Download 2016 primary care update

The Northwest Ohio Osteopathic Association
In Partnership with
The University of Toledo, Center for Continuing Medical
Education
Present the:
2016 PRIMARY CARE UPDATE
Friday, November 11 – Sunday November 13, 2016
Kalahari Resort and Conference Center
7000 Kalahari Dr
Sandusky, OH 44870
NWOOA
NORTHWEST OHIO
OSTEOPATHIC
ASSOCIATION
Treating our families and yours
Please be sure to visit our exhibitor booths:
PLANNING COMMITTEE MEMBERS
Nicholas J. Pfleghaar, D.O.
Program Director
President, Northwest Ohio Osteopathic Association
BG Family Physicians
Nicholas G. Espinoza, D.O.
State Trustee, Northwest Ohio Osteopathic Association
Dean of CORE St.Vincent’s Hosp., Toledo, OH
Med Director, The Falcon Health Center, Bowling Green, OH
Kris L. Lindbloom, D.O.
President Elect, Northwest Ohio Osteopathic Association
Hospitalist, Firelands Hospital
Tracey O’Neal Hooker, D.O.
Local Trustee, Northwest Ohio Osteopathic Association
Jennifer Pfleghaar, D.O.
Local Trustee, Northwest Ohio Osteopathic Association
John T. Rooney, D.O.
Secretary/Treasurer, Northwest Ohio Osteopathic Association
Verde Valley Medical Center
Joy A. Studer, ED
Executive Director, Northwest Ohio Osteopathic Association
Roger L. Wohlwend, D.O.
Local Trustee, Northwest Ohio Osteopathic Association
William J. Davis, D.D.S., MS
Associate Dean, CME
The University of Toledo
Becky Roberts
Sr. CME Coordinator
The University of Toledo
FACULTY
Constance P. Cashen, DO, FACOS, FACS
Associate Professor, St George’s University;
Director, Medical Education, Program Director
Osteopathic General Surgery Residency Program,
Mercy St Vincent Medical Center; Chairperson
General Surgery, Clinical Professor, General
Surgery Ohio University Heritage College of
Osteopathic Medicine
Cleanne Cass, DO
Director, Community Care and Physician
Education, Hospice of Dayton; Professor, Palliative
Medicine, Ohio University Heritage College of
Osteopathic Medicine; Adjuvant Clinical Faculty,
Department of Family Medicine, Wright State
University Boonshoft College of Medicine
Robert J. Cromley, DO
Family Medicine Private Practice; Medical
Director, Stein Hospice; Family Medicine Adjunct
Faculty, Ohio University Heritage College of
Osteopathic Medicine; Clinical Preceptor, Des
Moines University College of Osteopathic
Medicine
A Thomas Dalagiannis, MD, FACS
Chief of Plastics, St Vincent Mercy Medical
Center. St Luke’s Hospital, Toledo Hospital;
Private Practice, Arrowhead Plastic Surgeons
David Degnan
Instructor, American Heart Association, AHA
Instructor Trainer, Promedica Fremont Memorial
Hospital, Sandusky Fire Chief
Gregory Kramp, PharmD, RPh
Pharmacy Manager, Rite Aid Pharmacy
Carlos G. Lowell, DO
Des Moines University, College of Osteopathic
Medicine; Firelands Regional Medical Center, DO
Rotating Internship; Medical College of
Wisconsin, Psychiatric Residency; TMS Institute
of Ohio, Medical Director
George Thomas Magill, MD
Medical Director, Wound Care Services
Richard M. Miller, DO, FAOAO
Orthopaedic Surgery Residency Program Director,
Mercy St Vincent Hospital; Clinical Associate
Professor, Orthopaedic Surgery, Ohio University
Heritage College of Osteopathic Medicine
Nicholas M. Naudad, DPM
Private Practice, Advanced Foot and Ankle of NW
Ohio
Ajith K. Pai, MD, FACA, DABA
Associate Professor, Anesthesiology and Pain
Medicine, Des Moines University; Associate
Professor, Anesthesiology, Ohio University
Sarath K. Palakodeti, DO
Attending General and Cosmetic Surgeon, Toledo
Clinic
Sarah E. Pawlicki, Esq., SPHR, SHRM-SCP
Eastman & Smith, Ltd.
Brent C. DeVries, DO
ProMedica Physicians Cardiology
Laura T. Phillipps, RN, MSN, CHPN
Nurse Educator, Hospice of Northwest Ohio;
Terry Mark Gibbs, DO, NCMP
Promedica Obstetrics, Gynecology, Robotic
Surgery
James E. Preston, DO, FAODME
Senior Medical Director, Stein Hospice and
Palliative Care Inc.; Assistant Dean, Clinical
Affairs, Ohio University Heritage College of
Osteopathic Medicine; Program Director, Firelands
Regional Medical Center; Fellowship, Hospice and
Palliative Medicine
Erin Hennessey, DNP, APRN, FNP
Director, RN/BSN Program, Mercy College of
Northwest Ohio
Tracy A. Karolyi, DO, FACOP
Clinical Assistant Professor of Pediatrics, Ohio
University College of Osteoapathic Medicine
C. Jeff Kesler, MD FACS
Private Practice, Plastic, Cosmetic and
Reconstructive Surgery, Head and Neck Surgery,
Hand Surgery, Arrowhead Plastic Surgeons
Todd Rambasek, MD, FAAAAI
Clinical Allergist/Immunologist
Judge Jodi Debbrecht Switalski
Attorney, Family Law, Criminal Municipal and
Medical Malpractice, Giarmarco, Mullins &
Horton P.C.; Judge, Waterford District Court
Robert M. Stutman
The Stutman Switalski Group, LLC
DISCLOSURES
FACULTY DISCLOSURES
Dr. Gibbs discloses he is a speaker and receives honorarium from Pfizer.
Dr. Rambasek discloses he is a speaker and receives honorarium from Mylan.
Robert Stutman discloses he is a speaker and receives honorarium from Quest Diagnostics,
Linden Care and Solo Technologies.
Jodi Debbrecht Switalski discloses she is a speaker and receives honorarium from Quest
Diagnostics, Linden Care and Solo Technologies.
Drs. Cashen, Cass, Cromley, Dalagiannis, Karolyi, Kesler, Lowell, Miller, Nadaud, Pai,
Palakodeti, Preston nor David Degnan, Brent DeVries, Erin Hennessey, Gregory Kramp,
Laura Phillips, George Magill, or Sarah Pawlicki do not have any financial interest or other
relationship with any manufacturer of commercial product or service to disclose.
PLANNERS
Drs. Davis, Espinoza, Lindbloom, Jennifer Pfleghaar, Nicholas Pfleghaar, O’Neal Hooker,
Rooney, Joy Studer and Becky Roberts do not have any financial interest or other
relationship with any manufacturer of commercial product or service to disclose.
ACCREDITATIONS
AOA AACCREDITATIONS
The NWOOA certifies credit hours in conjunction with the OOA, directly to the AOA with the
requirements and policies of the AOA. A total of up to 23 Category 1A credits will be
requested from the American Osteopathic Association.
This activity has been planned and implemented in accordance with the accreditation
requirements and policies of the Accreditation Council for Continuing Medical Education
(ACCME) through the joint providership of the University of Toledo and Northwest Ohio
Osteopathic Association. The University of Toledo is accredited by ACCME to provide
continuing medical education for physicians. The University of Toledo designates this live
activity for a maximum of 23 AMA PRA Category 1 CreditsTM. Physicians should claim only
credit commensurate with the extent of their participation in the activity.
This Live activity, 2016 NWOOA Primary Care Update 2016, with a beginning date of
11/11/2016, has been reviewed and is acceptable for up to 22.75 Prescribed credit(s) by the
American Academy of Family Physicians. Physicians should claim only the credit
commensurate with the extent of their participation in the activity.
The Ohio Board of Nursing will accept, at face value, the number of hours awarded for an
educational activity that has been approved for CE, provided it was approved by a nationally
accredited system of CE approval.
The AAPA accepts certificates of participation for educational activities, certified for Category
1 credit from AOACCME, Prescribed credit from AAFP, and AMA PRA Category 1 CreditTM
from organizations accredited by ACCME or a recognized state medical society.
EVALUATION/CERTIFICATE
Evaluations will be readily available online daily at the start of the program. Evaluation is an important
component of continuing education programs. In addition to providing feedback to the program planners and
faculty, it provides information to improve future programs. The evaluation is an integral part of your
participation in this meeting.
TO OBTAIN YOUR CME CREDIT
Evaluations will be readily available each day after the program, and
MUST be completed for all days you attend order to receive a
certificate. Certificates will be available online on Monday, November
14, 2016 after 12 noon. Follow the instructions below:
 Go to website cme.utoledo.edu
 Click on Direct Link to Login
 Login: lastnamefirstname (no commas, no spaces)
Password: zip code (unless you have changed in our system previously)
 If you have not completed your online evaluations: You will be immediately directed
to an “Online Forms Inbox”
o Click on the evaluation form for the activity,
Complete every field and hit “Submit”
o You will be directed to view/print your certificate
 If you have completed your online evaluations:
o Choose “Credit Transcript” in the left side margin
o Next to the activity, will be a certificate icon, click it and print your certificate
o Remember each day has a certificate
FRIDAY, NOVEMBER 11, 2016 9 credits
7:00 a.m. -7:55 a.m.
Registration/Breakfast - West Pathway
Moderator:
Nicholas J. Pfleghaar, D.O.
8:00 a.m.-9:00 a.m.
Diabetic Lower Extremity Health
Nicholas M. Nadaud, DPM
9:00 a.m.-10:00 a.m.
Hormone Therapy: Past, Present, Future
Terry Mark Gibbs, D.O., NCMP
10:00-10:30 a.m.
Break/View Exhibits - West Pathway
10:30-11:30 a.m.
Colorectal Cancer: Hitting Your Screening Target
Constance P Cashen, D.O. FACOS, FACS
11:30 a.m.-12:30 p.m.
Ohio’s Opioid Guidelines, Laws and Rules:
Protecting the Patient and the Prescriber
Cleanne Cass, D.O.
12:30 p.m.-12:45 p.m.
Lunch Buffet Line (Lunch and Learn)
12:45 p.m.-1:45 p.m.
The Five Common Disorders of the Hand Seen by PCP’s
C. Jeff Kesler, M.D., FACS
1:45 p.m.-2:45 p.m.
See Spot Change: Identification and Management in Primary Care
Erin Hennessey, DNP, APRN, FNP-C
2:45 p.m.-3:00 p.m
Break /View Exhibits-West Pathway
3:00 p.m.-4:00 p.m.
Plastic Surgery Overview for the PCP
A. Thomas Dalagiannis, M.D., FACS
4:00 p.m.-5:00 p.m.
Common Pediatric Sightings
Tracy A. Karolyi, D.O., FACOP
5:00 p.m.-6:00 p.m.
Angioedema
Todd Rambasek, M.D., FAAAAI
SATURDAY, NOVEMBER 12, 2016 9 credits
7:30 a.m.-7:55a.m.
Registration/Breakfast - West Pathway
Moderator:
Nicholas G. Espinoza, DO
8:00 a.m.-9:00 a.m.
Issues in Pain Management
Ajith K. Pai, M.D., FACA, DABA
9:00 a.m.-10:00 a.m.
Workplace Issues Associated with Legalized Medical Marijuana
Sarah E. Pawlicki, Esq., SPHR, SHRM-SCP
10:00 a.m.-10:30 a.m.
Break /View Exhibits - West Pathway
10:30 a.m.-11:30 a.m.
Prescribing Naloxone and Management of Chronic Non-Cancer Pain
Gregory Kramp, PharmD, RPh
11:30 a.m.-12:30 p.m.
Risk Evaluation and Mitigation Strategies (REMS) for
Extended-Release and Long-Acting Opioids
James E. Preston D.O., FAODME
12:30 p.m.-12:45 p.m.
Lunch Buffet (lunch and Learn)
Moderator:
Jennifer Pfleghaar, D.O.
12:45 p.m.-1:45 p.m.
Risk Evaluation and Mitigation Strategies (REMS) for
Extended-Release and Long-Acting Opioids
James E. Preston D.O., FAODME
1:45 p.m.-3:45 p.m.
Osteopathic Manipulation in a Busy Practice
Robert J. Cromley, D.O.
3:45 p.m.-4:00 p.m.
Break/View Exhibits – West Pathway
4:00 p.m.-6:00 p.m.
Drugs in America 2016
Robert M. Stutman & Judge Jodi Debbrecht Switalski
SUNDAY, NOVEMBER 13, 2016 5 credits
7:00 a.m.
Breakfast Buffet - West Pathway
Moderator:
Roger L. Wohlwend, D.O. 7:00 a.m.-9:00 a.m.
Breakfast Buffet Served
8:00 a.m.-9:00 a.m.
Breast Cancer Update 2016:
The Latest in Diagnosis and Treatment
Sarath K. Palakodeti, D.O.
9:00 a.m.-10:00 a.m.
Young , Healthy…and Immortal: Discussing Advance Directives
with Patients Who Don’t Think They Need Them
Laura T. Phillipps, RN, MSN, CHPN
10:00 a.m.-11:00 a.m.
The Basic Principles and History of Hyperbaric Oxygen Therapy
George Thomas Magill, M.D.
11:00 a.m.-12:00 p.m.
TMS Therapy: A Unique and Proven Approach to Treating
Depression
Carlos G. Lowell, D.O.
12:00 pm.-1:00 p.m.
The Anterior Approach to Hip Replacement
Richard M. Miller, D.O., FAOAO
Or
8:00 a.m.-1:00 p.m.
ACLS Recertification - Tamarind Room
Brent C. DeVries, D.O. & Captain DavidDegnan, Fire Chief
COME AND JOIN US
FOR
A PIZZA
PARTY
SPONSORED BY THE:
NORTHWEST OHIO
OSTEOPATHIC
ASSOCIATION
Saturday, November 12, 2016
BEGINNING AT 6:30 PM
IN ZAMBESI ROOM
FRIDAY, NOVEMBER 11, 2016 9 credits
7:00 a.m. -7:55 a.m.
Registration/Breakfast - West Pathway
Moderator:
Nicholas J. Pfleghaar, D.O.
8:00 a.m.-9:00 a.m.
Diabetic Lower Extremity Health
Nicholas M. Nadaud, DPM
9:00 a.m.-10:00 a.m.
Hormone Therapy: Past, Present, Future
Terry Mark Gibbs, D.O., NCMP
10:00-10:30 a.m.
Break/View Exhibits - West Pathway
10:30-11:30 a.m.
Colorectal Cancer: Hitting Your Screening Target
Constance P Cashen, D.O. FACOS, FACS
11:30 a.m.-12:30 p.m.
Ohio’s Opioid Guidelines, Laws and Rules:
Protecting the Patient and the Prescriber
Cleanne Cass, D.O.
12:30 p.m.-12:45 p.m.
Lunch Buffet Line (Lunch and Learn)
12:45 p.m.-1:45 p.m.
The Five Common Disorders of the Hand Seen by PCP’s
C. Jeff Kesler, M.D., FACS
1:45 p.m.-2:45 p.m.
See Spot Change: Identification and Management in Primary Care
Erin Hennessey, DNP, APRN, FNP-C
2:45 p.m.-3:00 p.m
Break /View Exhibits-West Pathway
3:00 p.m.-4:00 p.m.
Plastic Surgery Overview for the PCP
A. Thomas Dalagiannis, M.D., FACS
4:00 p.m.-5:00 p.m.
Common Pediatric Sightings
Tracy A. Karolyi, D.O., FACOP
5:00 p.m.-6:00 p.m.
Angioedema
Todd Rambasek, M.D., FAAAAI
Diabetic Lower Extremity Health
Nicholas M. Nadaud, DPM
Learning Objectives:
Outline how to perform foot screening effectively using accepted screening tools
Describe foot ulcer risk following foot screening.
Identify referral pathways and describe when, where and who to refer.
Discuss effective and targeted foot health education for people with diabetes.
10/31/2016
Diabetic Lower Extremity Health
Nicholas Nadaud DPM
Advanced Foot and Ankle of NW Ohio
Toledo Ohio
Diabetes Impact
• Nearly 24 million people, or 8 percent of the U.S. population, have diabetes
• 17.9 million people have been diagnosed
• 5.7 million people are still undiagnosed
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Risk Factors for Ulceration
 Social / cultural habits







Mobility
Deformities
Vascular status
Neurological status Skin lesions: ulcers, callus, blisters
Footwear
Compliance & understanding
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Risk Factors
• Ethnicity plays a large factor in developing diabetes. The following groups are at an increased risk:
African‐American
American Indian/Alaskan Native
Asian‐American
Pacific Islander Hispanic‐American/Latino
• Overweight or obese
• A family history of diabetes or gestational diabetes raises the risk
Signs & Symptoms
Diabetes warning signs in the feet:
•
•
•
•
•
•
Redness
Numbness
Swelling
Cold to touch
Inflammation
Decrease hair growth
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Diabetes’ Impact on the Feet
• Neuropathy ‐ causes numbness, burning or tingling and diminishes sensation in the feet. • Ulcers ‐ a breakdown of skin on the foot that is difficult to heal and often leads to infection.
• Amputations ‐ occur as a result of foot wounds and ulcers that do not heal.
Diabetes is a biochemical disease
• “Diabetes mellitus is a biochemical disease, but a large number of lower extremity complications of the disorder are due to biomechanical dysfunction.” (Source: Payne, 1998.)
• Diabetics may have altered biomechanics; or
• Present with a complication of any pre‐existing neurovascular or biomechanical dysfunction.
4
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Foot Ulceration
• Approximately 85% of diabetes‐related amputations start off with a foot ulcer that deteriorates, becomes infected & gangrenous!
Most foot ulceration CAN be avoided /prevented
Risk Factors for Ulceration
• Peripheral neuropathy
– Sensory
– Autonomic
– Motor
• Risk factors for neuropathy include:
hyperglycemia, elevated triglycerides, high BMI, smoking & hypertension.
10
5
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Risk Factors for Ulceration
Sensory Neuropathy
• Largest single risk factor for diabetic foot ulcers
– Burning, tingling, ”pins & needles”, numbness or “dead” feeling
– Repeated unrecognized stress, pressure, friction & shearing.
– Lack sensation to feel foreign objects, heat changes, discomfort or pain.
11
Risk Factors for Ulceration
Autonomic Neuropathy
• Impairs skin integrity, sweat regulation & blood flow.
• Leads to:
– thick, dry cracked skin, fissures
– callus build‐up at pressure points
6
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Risk Factors for Ulceration
Motor Neuropathy
• Loss of muscle tone in the foot
• Foot deformities:
–
–
Hammer toes
Claw toes
• Metatarsal heads become prominent
• Changes in pressure distribution & gait pattern
Risk Factors for Ulceration
Under diagnosis of neuropathy
• Fundamental problem in primary care.
• Impedes early identification, management & prevention of squeals .
7
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• Occur in presence of: peripheral sensory neuropathy, autonomic neuropathy and
trauma.
• Presentation: painless, unilateral oedema, erythema, with or without foot deformity, bounding pedal pulses. Post tib dysfunction in later stages.
Photo used with permission from Dr.Axel Rohrmann, Podiatrist.
CHARCOT FOOT Diabetic Neuropathic Osteoarthropathy
• Occur in presence of peripheral sensory neuropathy, autonomic neuropathy & trauma.
• Presentation: painless, unilateral edema, erythema, with or without foot deformity, bounding pedal pulses. Post tibial dysfunction in later stages.
• Note: –
–
–
–
Acute charcot can mimic cellulitis & DVT
Radiological findings can be normal at first
Strict immobilization of foot for management
Patient education, protective footwear to prevent ulcerations
8
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9
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Risk Factors for Ulceration
Calluses
• Presence of callus in an insensitive foot is highly predictive of subsequent foot ulceration.
• Breakdown of underlying tissues
• Regular debridement • Pressure relief : insoles / moulded orthotics
• Footwear
Calluses increase pressure on underlying tissue by 30%
Photo used with permission from Axel Rohrmann, Podiatrist.
11
10/31/2016
Risk Factors for Ulceration
Limited Joint Mobility
–
–
–
–
Hallux rigidus
Hallux limitus
Hammer toes
Claw toes
Limited joint mobility can cause increased
ground reaction forces under weight‐bearing joints. This can lead to ulceration.
Photo used with permission from Dr. Axel Rohrmann, Podiatrist.
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Risk Factors for Ulceration
Previous Ulceration & Amputation
• Skin texture • Scar tissue reduced tensile strength. • Pressure points
Prevalence of Ulcers
• Up to 25 percent of those with diabetes will experience an ulcer or wound at some point.
• Amputation rates can be reduced by 45 to 85 percent with a comprehensive foot care program.
• Without proper treatment, ulcers can quickly escalate into amputation.
13
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Early Detection is Key
• A simple foot exam can reveal the first signs and symptoms of diabetes, and identify more serious complications that could potentially lead to lower‐limb amputations.
Multi‐Specialty Care
•
•
•
•
•
•
Primary Care/Internal Medicine
Endocrinology
Podiatry
Opthamology
Vascular Surgery
Nutritionist
14
10/31/2016
Podiatry Savings
• Limbs
• Cost
• Quality of life
DIABETIC FOOT HEALTH • Up to 25%of those with DIABETES will develop a FOOT ULCER • COST OF DIABETES IN THE US $245B • Estimated annual U.S. burden of diabetic foot ulcers is at least $15 BILLION 15
10/31/2016
INVESTMENT IN CARE • $1 invested in care by a podiatrist results in $27 to $51 of savings for the health‐care system, • $1 invested in care by a podiatrist results in $9 to $13 of savings, among Medicare eligible patients.
How to Examine?!
• The three minute diabetic foot exam
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10/31/2016
Three Minute Exam
• What to ask
– H/O previous ulcer or amputation?
– Vascular intervention (stents, angioplasty, bypass)
– Wounds >3wks to heal? Unexplained foot blisters?
– Smoking/nicotine useage
– Do you have a Foot doctor??
Three Minute Exam What to check for
• Dermatological
– Dystropic toenails? Ingrown?
– Corns/calluses/fissured heels?
– Between the toes?
– Skin color changes
• Neurological
– Light touch sensation – Semmes weinstein 5.07/10g monofilament
17
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Three Minute Exam What to check for
• Vascular
–
–
–
–
Hair growth?
Temperature gradient proximal to distal
Foot pulses
CFT
• Muscularskeletal
– Hammertoes (reducible vs not)
– Equinus
– Midfoot arthritis 18
10/31/2016
Three Minute Exam
What to tell the patient
•
•
•
•
•
•
Check feet nightly (mirror or family member)
Dry feet throughly
Report any new changes to feet
NO barefoot walking
Replace shoes Yearly and inserts every 4 months
QUIT SMOKING
• The 5 most dangerous words to a diabetic
– “Maybe this will go away”
Mapping a Treatment and Follow‐up Plan
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For More…
• Visit www.apma.org to “Find a Podiatrist”
• Visit www.apma.org/diabetes for more diabetes information
• Visit www.Foothealthfacts.org for common foot and ankle pathology
Questions?
20
Hormone Therapy
Past, Present, Futureh
Terry Mark Gibbs, D.O.
Learning Objectives:
Recognize guidelines for hormone therapy use.
Evaluate starting hormone therapy.
11/9/2016
HORMONE THERAPY:
PAST, PRESENT, FUTURE
Terry Gibbs DO,NCMP
Sandusky 2016
HISTORY OF ESTROGEN

Early 1900’s- Women drink solutions of animal ovaries to treat
menopause symptoms

Mid 1930’s -Drug companies produce estrogen injections and
pills from animal placentas and fetal fluid to relieve symptoms
of menopause
1
11/9/2016
HISTORY OF ESTROGEN CONT.

1941-1942-Ayerest produces Premarin estrogen produced from
urine of pregnant mares

1951- Sex researcher William Masters re-commends hormone
therapy to rejuvenate mental and physical function
HISTORY OF ESTROGEN CONT.

1953- Mayo Clinic Scientists postulate that estrogen is cardioprotective (Autopsies show women with ovaries removed suffered
more advance atherosclerosis than women with ovaries)

1950s- concerned by animal studies suggesting estrogen is
carcinogenic, physicians only prescribed estrogen primarily for
short-term relief
2
11/9/2016
HISTORY OF ESTROGEN CONT.

1966- Gynecologist, Robert Wilson writes Feminine Forever,
promotes
estrogen use through a drug
company sponsored
foundation.
HISTORY OF ESTROGEN CONT.

1975- Studies show a link between estrogen and endometrial
cancer

1979- Ten year study finds
estrogen taken within 3
years
of menopause onset reverses
bone
loss
3
11/9/2016
HISTORY OF ESTROGEN CONT.

1984- FDA and NIH sanction estrogen as the most effective drug to
prevent osteoporosis

1985- Nurses Health Study, concludes estrogen users have lower
risk of heart disease

1985- but… the Framingham Study finds the opposite
HISTORY OF ESTROGEN CONT.

1991- More than twenty small studies estimate that HT halves
heart disease in menopausal women.

1992- The American College of Physicians recommends HT to all
women to prevent cardiovascular disease and osteoporosis
4
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HISTORY OF ESTROGEN CONT.

1994- First randomized controlled clinical trial (RCT) of combined
HT, shows better cholesterol scores for women taking HT

1998- Four-Year Heart and Estrogen/ Progesterone Replacement
Study finds HT does not reduce heart attacks in women whom
already have heart disease
HISTORY OF ESTROGEN CONT.

2002- Estrogen/Progesterone arm of the 27,000 subject
Women’s Health Initiative Study (WHI) is halted three years
early when it substantiates increased risk of breast cancer,
heart attacks, strokes and blood clots
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HISTORY OF ESTROGEN CONT.

2004- Estrogen, (Premarin) arm of the WHI study is ended a
year ahead of schedule because estrogen alone offered
no cardio-protective benefit but increased the risk of blood
clots and stroke
WOMEN’S HEALTH INITIATIVE (WHI), AGES
50-79
HORMONE PROGRAM DESIGN
Women who had
no uterus at
start of study
YES
N= 10,739
Placebo
Hysterectomy
Women who had
a uterus at
start of study
Conjugated equine
estrogen (CEE) 0.625 mg/d
NO
N= 16,608
CEE 0.625 mg/d +
medroxyprogesterone
acetate (MPA) 2.5 mg/d
Placebo
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WHI Estrogen+Progestin Trial Findings, July 2002
( N=16,608; mean age 63 yrs; mean follow-up 5.2 yrs)
Risks
Benefits
Coronary Heart Disease
29% 
Stroke 41% 
Pulmonary Embolism
113% 
Breast Cancer 26% 
Hip Fracture 34% 
Colorectal Cancer 34% 
Threshold Level
STOPPED Early,
Clear Harm
Dementia 105% (age 65+)
Stopped 3.3 years early
Adapted from: Writing Group for the Women’s Health Initiative. JAMA 2002;288:321.
WHI Estrogen-Alone and Health Outcomes
(N=10,739; mean age 63.6 yrs; mean follow-up 6.8 yrs)
Risks
Null
Benefits
Stroke 39% 
CHD (0.91)
Pulm Emb (1.34)
Breast Cancer (0.77)
Colorectal Cancer (1.08)
Total Mortality (1.04)
Global Index (1.01)
Hip Fracture 39% 
STOPPED Early
Threshold Level
Dementia 49% (age 65+)
Stopped 1 year early
Source: JAMA 2004; 291:1701.
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Key Differences Between the WHI and
Observational Studies of Hormone Therapy (HT)
WHI
Observational
Studies
Age at HT initiation (mean)
63 yrs
52 yrs
Time since menopause (mean)
>12 yrs
1-3 yrs
Generally –
Generally +
28-30
24-25
Vasomotor symptoms
BMI (kg/m2, mean)
Estrogen+Progestin Therapy and Risk of CHD in WHI:
Results According to Age and Time Since Menopause
Age
RR
Time since
Menopause Onset
50-59
1.27
<10 yrs
0.89
60-69
1.05
10-19 yrs
1.22
70-79
1.44
>20 yrs
1.71*
P, interaction 0.4
RR
P, interaction 0.036†
* P-value <0.05
† meta-regression analysis (0.33 as continuous variable)
Source: Manson JE, et al. NEJM 2003.
8
11/9/2016
Women’s Health Initiative Estrogen-Alone Trial:
Detailed CHD Results According to Age at Randomization
RR (95% CI) by Age Group at Baseline
Outcome
50-59
60-69
70-79
MI or CHD Death
(N=418)
0.63
0.94
1.11
(0.36-1.08)
(0.71-1.24)
(0.82-1.52)
CABG or PCI
(N=529)
0.55
0.99
1.04
(0.35-0.86)
(0.78-1.27)
(0.78-1.39)
Composite MI/CABG/PCI
(N=728)
0.66
1.02
1.08
(0.44-0.97)
(0.83-1.25)
(0.85-1.38)
CEE = conjugated equine estrogens. MI = myocardial infarction. CABG = coronary artery bypass grafting.
PCI = percutaneous coronary intervention
Source: J Hsia, R Langer, J Manson, et al. Arch Intern Med 2006.
Absolute Excess Risks (cases per 10,000 pys) by Age in the
Combined Trials (E+P and E-Alone) of the WHI
Outcome
Age (years)
50-59
60-69
70-79
CHD
-2
-1
+18*
Stroke
+2
+14*
+15*
Total mortality
-10*
-4
+14
Global index†
-4
+12
+44*
* P <0.05
† Global index is a composite outcome of CHD, stroke, pul embolism, breast ca, colorectal ca, endometrial ca,
hip fracture and mortality
Source: Rossouw JE, Prentice RL, Manson JE, et al. JAMA 2007.
9
11/9/2016
Timing of Hormone Therapy Initiation in Relation to Stage of Atherosclerosis:
Observational Studies vs Clinical Trials
Premenopausal Years
Postmenopausal Years
Years Since Menopause Onset
10
15
5
Observational Studies
20
Clinical Trials
(1° and 2° Prevention)
Progression of
Cardiovascular
Disease
Fatty streaks
Fatty plaques
Atherosclerotic plaques
Favorable Lipid and
Endothelial Effects of
Estrogen Predominate
Plaques grow and may rupture
Prothrombotic and
Proinflammatory Effects of
Estrogen Predominate
(plaque rupture, thrombo-occlusion)
Favorable Influence
From: J Manson, et al. Menopause 2006.
Adverse Influence
of Initiating
of Initiating
Exogenous Estrogens
Exogenous Estrogens
Relative Risk of Breast Cancer with E+P and E-Alone
in the WHI, Stratified by Age Group
Relative Risk by Age Group at Baseline
50-59
60-69
70-79
E+P
1.20
1.22
1.34
E-Alone
0.72
0.72
0.94
Source: Chlebowski R, et al. JAMA 2003.
WHI Investigators. JAMA 2004.
10
11/9/2016
The statement was published in the journals of
The North American Menopause Society (Menopause),
the American Society for Reproductive Medicine
(Fertility and Sterility), and The Endocrine Society
(Journal of Clinical Endocrinology and Metabolism)
ENDORSING ORGANIZATIONS

Academy of Women’s Health

American Academy of Physician Assistants

American Academy of Family Physicians

American Association of Clinical Endocrinologists

American Medical Women’s Association

Asociación Mexicana para el Estudio del Climaterio

Association of Reproductive Health Professionals

National Association of Nurse Practitioners in Women’s Health

National Osteoporosis Foundation

Society for the Study of Reproduction

Society of Obstetricians & Gynaecologists of Canada

SIGMA Canadian Menopause Society
11
11/9/2016
DURATION OF USE
 With
EPT, increased risk of breast cancer
incidence and mortality with 3-5 years of
use
 With
ET, no increase of breast cancer with
early postmenopausal use; decrease
found after hiatus in estrogen exposure
 With
ET, potential CAD and CHD benefits
with early use
 Initial
increase in CHD risk when EPT is
initiated further from menopause
(cont’d)
NAMS position statement. Menopause 2012.
DURATION OF USE (CONT’D)

Extending EPT use is acceptable for:
 Women
who request it and are well
aware of potential risks and benefits
 Prevention
of further osteoporosisrelated fracture and bone loss when
alternate therapies are not
appropriate or cause unacceptable
adverse effects
NAMS position statement. Menopause 2012.
12
11/9/2016
DISCONTINUATION
 After
3 years of EPT discontinuation:

Rate of cardiovascular events, fractures,
and colon cancer same as placebo group

Increase in rate of all cancers and mortality
from breast cancer
 After
3 years of ET discontinuation:

No increase in CHD, DVT, stroke, hip fracture, colorectal cancer,
or total mortality

Decrease in breast cancer persisted
(cont’d)
DISCONTINUATION
(CONT’D)

HRs for all-cause mortality neutral
for both

50% chance of vasomotor symptoms recurring when HT
discontinued

Symptom recurrence similar whether tapered or abruptly
discontinued

Decision to continue HT should be individualized
NAMS position statement. Menopause 2012.
13
11/9/2016
14
11/9/2016

Hormone therapy still has a role in treating moderate-to-severe
menopausal symptoms but shouldn’t be used for chronic disease
prevention. Risk stratification (based on time since menopause
and underlying risk factors) can be helpful in identifying
appropriate candidates for hormone therapy.
SUMMARY
15
Colorectal Cancer:
Hitting Your Screening Target
Constance P. Cashen, D.O., FACOS, FACS
Learning Objectives:
Discuss current statistics about colorectal cancer in the US.
Recognize what the American Cancer Society’s “80% by 2018 Colorectal Cancer
Screening Campaign” is about.
Identify what screening tests will meet the CMS screening guidelines.
11/8/2016
Colorectal cancer:
Hitting your
Screening Target!
CONSTANCE CASHEN D.O. FACOS FACS
NOVEMBER 11, 2016
Objectives:

1. Understand the current statistics about colorectal cancer in the
United States.

2. Know what the American Cancer Society’s “80% by 2018
Colorectal Screening Campaign” is about.

3. Know what screening tests will meet quality performance
guidelines.
1
11/8/2016
CRC Stats
*A COMMON and LETHAL CANCER:
•
2nd most common ca in women, 3rd in men
•
Lifetime incidence in the US is 4.5%
** The SECOND MOST COMMON CAUSE OF CANCER DEATH in the US
***1 in 3 people diagnosed with CRC will die***
Screening can decrease deaths by
finding cancer early

Early diagnosis can save lives:

Localized disease (confined to colon wall) means 5 yr treatment
survival is 90%

Regional disease (lymph nodes positive) means 5 yr treatment
survival is 68%

Distant metastases at diagnosis means 5 yr treatment survival is sadly
only 10%
2
11/8/2016
But better yet - Screening can
actually prevent CRC in the 1st place

The Polyp – Cancer connection

Focal hyper-proliferation of colorectal epithelial cells forms
adenomas also called adenomatous polyps

Over 7 – 10 yrs adenomatous polyps can progress to cancer

But although 50 – 65% of polyps will be adenomas, the good news is
that less than 5% of them will advance to malignancy

In addition to the common pedunculated adenomatous polyp we
all know there is also a more flat “sessile serrated adenoma” which
occurs more often in the proximal colon and carries similar potential
for cancer

Both types when removed will prevent CRC
Screening impact

Since the mid-1980’s the incidence of CRC has
steeply dropped from 80/100,000 men and
55/100,000 women to 45/100,000 men and
35/100,000 women

This is attributed largely to colonoscopic polypectomy
3
11/8/2016
Screening methods – are thought
of as falling into 2 categories
Structural tests that find both polyps and cancer
Colonoscopy, Flexible sigmoidoscopy, DCBE, CT Colonography
Stool tests that primarily detect cancer
Fecal Occult Blood Testing(FOBT),
Fecal Immunochemical Test (FIT),
Stool DNA test (Cologuard)
Though Colonoscopy is the gold
standard, the rest have value
 Flexible
sigmoidoscopy

Examines the rectum, sigmoid and descending colon

Less bowel prep

Deep sedation usually not used so some may have discomfort

Risk of perforation <1 / 20,000

If adenoma is found then colonoscopy is required

A large study in the UK showed that compared to no screening
there was a 23% decrease in incidence and a 31% decrease in
mortality from CRC with FS (followed by c-scope if polyp found and
obviously detected polyps were removed)
4
11/8/2016
What’s the risk of not evaluating
the rest of the colon?

2 large studies done in 2000 showed 30/2000 people
screened (a single company) and 80/3122 VA patients
screened who had negative flex sigs were later found to
have advanced proximal neoplasia when they
developed symptoms

Based on these studies apprx 1.5 – 2.5% of patients
screened with flexible sigmoidoscopy will have a
proximal cancer or premalignant polyp that progresses
to cancer that will be missed
Hence Colonoscopy is the most
commonly used screening test in the US

The entire colon is examined and any polyps or lesions can be
biopsied or removed

However it does require a good bowel prep which can
be inconvenient and uncomfortable, and requires
sedation so a workday for the pt and a chaperone is lost

Overall complications are 2.8 in 1000 scopes

Perforation is 1/1000 scopes overall with more occurring in the
elderly and those with diverticulosis – 1/500 Medicare pts

Post polypectomy bleeding is .2%

$2500-3000 cost
5
11/8/2016
Colonoscopy

Anesthesia risks – either conscious sedation (ie Versed and fentanyl)
or MAC (monitored anesthesia care typically using propafol)
include cardiac arrhythmias, hypotension, and O2 desaturation in
5.4 of 1000 scopes (.5%)

Missing polyps can occur based on size:

2% miss for polyps> 10mm

13% miss for polyps 5-10 mm

26% miss for polyps <5mm

The golden rule of colonoscopy is that you should spend a minimum
of 6 minutes withdrawing the scope to see the colon thoroughly
Surveillance Interval if polyp(s)
found

No polyp
10 yrs

Small hyperplastic polyps
10 yrs

1-2 small <10mm tubular adenoma polyps

3-10 small aden polyps, tubular adenoma>10mm
3yrs

Villous adenoma or high grade dysplasia
3yrs

Sessile serrated polyp <10mm & no dysplasia
5yrs

SSP >10mm or dysplasia or traditional type
3yrs

Serrated polyposis syndrome
1yr

The doc performing the colonoscopy should indicate when the next
c-scope is due in the colonoscopy report.
5-10 yrs
6
11/8/2016
Imaging alternatives if patient
declines a scope for screening

DCBE – Double Contrast Barium Enema (barium and air)

Still requires a bowel prep though no sedation required

Like flex sigmoidoscopy, if a polyp is found (unless<6mm), then
colonoscopy will be needed (which means another prep)

Sensitivity for CRC is 85 – 97%. Frequency – every 5 yrs

CT Colonography – Multiple CT images are used to
reconstruct 2D and 3D images of the colon, no sedation required

Sensitivity for polyps>5mm is good at 90-94%, specificity 80-95%

Requires bowel prep and oral contrast and any polyps>5mm require
colonoscopy.
Frequency – every 5 yrs
Alternatives to tests requiring bowel
prep– Stool analysis tests

FOBT – Fecal Occult Blood Test

FIT – Fecal Immunochemical Test

Fecal DNA Test - Cologuard
7
11/8/2016
FOBT

Oldest screening test, several versions – works by detecting blood in
stool using the pseudoperoxidase activity of heme in hemoglobin

Recommend use Hemoccult SENSA

Advantages: cheap, long track record, no bowel prep

Sensitivity= 80-85%
Specificity= 88% (for older Hemoccult tests,
the specificity is higher-98%, but the sensitivity is only 40%)

Disadvantages: need to sample 3 stools (not random rectal exam in
office), variability in interpretation (“is it really blue?”), need to avoid
ASA/NSAIDs x 1wk and red meat & High Vit C 3 days (some
research shows only Vit C an issue due false neg results)

Any + needs C-scope follow up
Fecal immunochemical test- FIT

Works by detecting human globin not the heme component of
blood and since any globin from the UGI is digested, only bleeding
from the colon will be detected

Advantages: no drug or diet restrictions, only 1 sample, automated
interpretation vs a visual judgement

Sensitivity: 80% (for ca, ½ for polyps), specificity=90-95%

Disadvantages: need to mail it on time, more expensive ($30 vs 10)

+ result mandates C-scope

This is the most common strategy used by large companies
8
11/8/2016
Fecal DNA test

Detects DNA (KRAS) mutations and methylation biomarkers as well
as an immunochemical test for blood (similar to FIT)

Advantages: requires only 1 stool, no prep or restrictions, only needs
to be done every 3 yrs vs annual for FOBT/FIT, covered by Medicare

Sensitivity=92%

Disadvantages: need to collect an entire stool, cost ($600 in 2014)

+ test mandates C-scope but some question what it means if scope
is negative (does a neg scope mean next screen in 10yrs?)
Specificity=87%
Other tests that may become
options for screening

Blood-based markers

Look for DNA specific for CRC (ie Septin 9 study)

At best have a sensitivity=75% and specificity=85%

The higher the stage of CRC, the better the s/s so for Stage I CRC
the s/s was only about 65/65% - not a good option for early
detection or finding polyps

Colon capsule endoscopy – approved by the FDA but not in use yet

About the size of a vitamin pill, 2 cams, takes 10 hrs of pics, 35/sec

Sensitivity=85% for polyps, Specificity=65-95% (lesion size)

Requires more bowel prep than colonoscopy
9
11/8/2016
Current Screening Guidelines

USPSTF 2016:

Emphasizes the need for ANY screening strategy (vs none) for all
average risk adults age 50 – 75 (Grade A evidence) and to screen
selectively for age 75 – 85 (Grade C evidence of benefit)

Did not recommend one strategy over another since data
demonstrating superior risk/benefit ratio of any specific strategy is
lacking

The guideline supports the following: Colonoscopy q10, annual FIT +
Flex sigmoidoscopy q10, CT colonography q5, Flex sig alone q5,
Fecal DNA q3, FOBT or FIT q1
So what should I recommend to
patients?

Start with the 2008 American Cancer Society guidelines
(same as US Multi-Society Task Force on CRC and Am Coll of
Radiology)

They distinguish “tests that find cancers and polyps” from “tests that
find mostly cancers”

Start at age 50 unless in a higher risk group* then start at age 40

* a Fhx of CRC/polyps in any 1st degree relative <60y/o or two 1st
relatives >60

Since there is no “best test”, offer pts multiple screening options and
let them choose – however most common practice shows……
10
11/8/2016
Tests that find cancer and polyps

Flexible sigmoidoscopy

Every 5 yrs

Colonoscopy

Every 10 yrs

DCBE

Every 5 yrs

CT Colonography

Every 5 yrs
Tests that mainly find cancer

Fecal Occult Blood Testing

Every year

Fecal Immunochemical
Test (FIT)

Every year

Every 3 yrs

Stool DNA test
11
11/8/2016
Higher risk groups rec colonoscopy

With a positive family history - recommend colonoscopy as the best
screening strategy and start per the ACS guidelines and then follow
the recommended interval indicated by the physician performing
the study

If a patient is at higher risk because of a personal hx of polyps, CRC,
or IBD, strongly recommend that they have colonoscopy and then
follow as above

If they have multiple family members with cancer including CRC,
suspect a genetic syndrome and strongly recommend colonoscopy
as the preferred screening method
Remember to Document

Ideally document that your patient has been informed of the
importance of screening and that there are options

Maintain good follow up on screening intervals

Document if your patient declines to be screened (though the
quality parameter police don’t care about this!)

Nonetheless, encourage patients to get screened – by any method
– and tell them about the American Cancer Society’s initiative:
“80% by 2018” CRC screening goal which will save thousands of
Americans from death due to CRC (>140 organizations have joined
with the ACS to promote this since 2014)
12
11/8/2016
“80% by 2018” – 5 things the PCP
can do – rec’s from the ACS

1. Understand the power of the physician recommendation. Surveys
show that 90% of pts who were recommended by their physician to
get screened, did vs 17% who reported never getting a provider rec

2. Measure the CRC screening rate in your office/clinic (tools at
cancer.org/colonmd)

3. Use evidence-based practices like EHR alert systems and staff
alerts to identify those needing screening.

4. Understand screening options and actively promote
Colonoscopy, FOBT and FIT (with f/u c-scope if FOBT/FIT positive).

5. Make sure that patients and staff know that most insurance
companies are required to cover CRC screening.
And finally remember: YOU
CAN MAKE THE DIFFERENCE!
13
Ohio’s Opioid Guidelines, Laws and Rules:
Protecting the Patient and the Prescriber
Cleanne Cass, D.O.
Learning Objectives:
Define the difference between guidelines, rules and laws and how each impacts
opioid prescribing practices.
Describe the origin of Ohio’s opioid epidemic and the prescriber’s role in combating
it.
Describe the opioid guidelines, rules and laws currently in place that affect the
practice of medicine in Ohio.
11/7/2016
Ohio’s Opioid Guidelines, Laws and Rules: Protecting the Patient and the Prescriber
NorthwestOhioOsteopathicAssociation
16th AnnualPrimaryCareUpdate
Sandusky,Ohio
November11,2016
Today’s Discussion
• Understandthedifferencesbetweenguidelines,rules
andlawsandhoweachimpactsprescribingpractices
• Describetheoriginsoftheopioid epidemicandthe
prescriber’sroleincombatingit
• Describeopioid guidelines,lawsandrulescurrentlyin
placeinOhioandhowtoutilizethemforsuccessful
painmanagementinyourpractice
2
1
11/7/2016
Conundrum for Physicians:
“TwinSerpentsintheCaduceus”
Toassurethat
werelievethe
painofour
patients,
but……
…...neverallowour
medicationstofall
intothehandsof
thosetheymay
harm
The Physician’s Dilemma:
“TwinserpentsintheCaduceus”
•UndertreatedPainandrelatedcosts:
‐ Nationally100millionAmericanswith
chronicpainatacostof>635billion
dollars
IOMReportonPain‐ 2011
•OpioidAbuseandrelatedcosts
‐ Nationally>6millionAmericansabusing
opioidsatacostof70billionperyear
MoneyMagazineAugust,2009
4
2
11/7/2016
Institute of Medicine Report –
June, 2011:
• Treatingpainisamoralimperative
• Increaseresearch/educationonpain
• Biopsychosocial modelofpain
managementimprovesoutcomes
• Transformationinourculturalviewof
painisneeded
5
Chronic Pain – the new 4 letter word
• Cancerpain:validated‐ reliefisanexpectation
• ChronicnonmalignantPain– societal
disapproval,treatmenthardtofind
• Patientswithchronicpainandtheir
prescribersaremarginalizedandeven
criminalized!!
6
3
11/7/2016
Chronic Pain
• Chronicpain‐ thepricetagforalifetimeof
activeliving?
• Chronicpain‐ thepriceofbeinganathlete?
• Chronicpaincanbetheresultoftheactivities
welove:jogging,boating,skiing
7
• 80%ofpatientspresentingforcarereportpainasa
reasonforseekingmedicalcare
• Undertreatedandimproperlytreatedacutepaincan
transitiontochronicpain:complexregionalpain
syndromes
• Undertreatedpainintheelderlyisariskfactorfor
alcoholabuse,deconditioning,andinstitutionalization
8
4
11/7/2016
Who has Chronic Pain?
• Patientswithchronicdegenerativeconditions:COPD,HF,
•
•
•
•
•
CKD
Patientswithmusculoskeletaldisorders‐ osteoporosis,
osteoarthritis,chronicinflammatoryconditions
Traumaticinjurysurvivors
Patientswithneuoromusculardisorders:MS,Huntington’s
chorea,ALS,postStrokepatients
Occupationalinjuryandoverusesyndromes
Chronicvisceralsyndromes:Crohn’sdisease,chronic
pancreatitis,etal.
9
Clinical Imperatives
Tobelievethepainofourrealpatients:
Allpatientspresentingwithpaindeserveadequateevaluation
andtreatmentbasedoncarefulconsiderationoftherisksand
benefits
ScottFishman,ResponsibleOpioid Prescribing
2nd edition,2014,p37
• Tobecomebetterpainmanagersandtreatpainin
mannerthatissafeandeffectiveforthepatient
• TounderstandandimplementOhio’sregulatory
oversightinordertoprotectourprescriptiverights
10
5
11/7/2016
Origins of the opioid epidemic
Aggressive
Marketingof
Opioids
Changesin
ClinicalPain
Management
Direct‐to‐
Customer
Marketing
Self‐Medicating
HabitsofBaby
Boomers
GrowingUseof
Prescriptive
Opioids
Epidemic
Diversion
*Internet
*PillMills
*Deception/Scams
*Theft
*Friendsand
family
Origins of the Opioid Epidemic in Ohio
• Pocketsofsocioeconomicdeprivation‐ concentrated
insoutheasternOhio
• Geneticpredispositiontoopioid addictionfollowssame
incidenceaspredispositiontoalchohol addiction:one
outofeverytenopioid naïvepatientsgivenanopioid is
atriskofaddiction‐ highincidenceofoxycodone
addictioninsoutheastOhioamongfamilygroups–
geneticpredisposition??
12
6
11/7/2016
Origins of the Opioid Epidemic
• “Itisunclearhowmuchabuse,diversionand
addictionistheresultofwellmeaningbut
under‐educatedorunder‐informed
physicians.”
ScottFishman,
ResponsibleOpioid Prescribing
2nd Edition,2014,p39
13
The Opioid Epidemic
• Thenumberofdeathsnationwideattributableto
prescriptionopioid analgesicsquadrupledbetween
1999and2007
• Opioid overdoseisthethe secondleadingcauseof
accidentaldeathinAmerica,exceededonlyby
vehiculardeath;in17statesopioid overdoseisthe
leadingcauseofaccidentaldeath
14
7
11/7/2016
Ohio and U.S. Unintentional Drug Overdose Death Rates per 100,000 Population 1999‐2006 U.S. /1999‐2008 Ohio
Number of Deaths from Motor Vehicle Traffic, Suicide and Unintentional Drug Poisonings by Year in Ohio 1999 – 2008 8
11/7/2016
Unintentional Drug/Medication Poisoning Death Rates per 100,000 by County 2004 – 2008
Response to the Epidemic: Guidelines for Pain Management ‐ State and Federal
•
•
•
•
•
Developedbyconsensusagreementofpanelsof
appointedexpertsandstakeholders
Reviewed,adaptedandapprovedbyprovider
organizations:OOA,OSMA,OAFP,OBP,etc
Areonlyguidelines– notrulesorlaws:“shoulds”and
not“shalls”
Usuallyconsideredtoconstitutestandardofcareand
thereforecanbeimportantinlitigation
Insurersmayusetodeterminepayment
18
9
11/7/2016
Laws
• Billsaresponsoredbylegislatorsandintroducedinto
thesenateorhouseofrepresentatives
• Generallyreferredtocommitteeinbothhouses
requirepublichearingsandifpassedmustbesigned
bythegovernor
• Whenenactedtheybecomethelawoftheland
• AprovisionofthebillwilldirectanagencysuchasODH
orOSMBtodeveloptherulesofthelaw
19
Rules
• Lawsdirectanagencyorbureautodevelop
rules– lawsareaskeletonandtherulesare
themuscle
• Theagencyorbureaumayconveneapanelof
expertsoruseitsownstandingboardsto
developrules
• Publichearingsandcommentsmayprovide
opinion
• Oncedevelopedandapprovedtherules
becomepartoftheOhioRevisedCode
20
10
11/7/2016
Federal Guidelines
•
NationalPainStrategy– 2011, developedbytheInstituteof
MedicineandNationalInstitutesofHealth
‐ validatedtheneedtoaddresspaininAmerica
•
CDCGuidelinesforManagingChronicPain– 2011– national
responsetotheopioid epidemic,endorsedfindingsinthestrategy
andrecommendedtreatment,education,research
•
CDCGuidelinesforManagingChronicPain,March,2016‐sharp
departurefromearlierguidelines‐ notfelttobeevidencedbased
andwidelycriticizedbytheAmericanAcademyofPain
Managementandothers
www.cdc.gov
21
WiththeexceptionoftheDEA,thefederal
governmentleavesregulationofopioid
prescribingtothestatesandnational
guidelinesaremeanttobeeducationaland
guideposts
Numerousotherguidelines:Federationof
StateMedicalBoards,AmericanPainSociety,
etc
22
11
11/7/2016
Ohio’s Automated Rx Reporting System –
Prescription Monitoring System
OhioRevisedCode– 4729.75‐4729.84EffectiveJanuary1,
2006,expandedregulationsHB93,HB341(effective
April1,2015)
•
Toolforprescribers,pharmaciststoidentifyandpreventabuse
andaddiction
•
Toolforlawenforcementtodeterdiversion
•
Pharmacistsmustenterdataelectronicallydaily
•
Reporteddrugs:scheduleCII,CIII,CIV,V,Carisoprodol (Soma)&
Tramadol (Ultram)effectiveDecember1,2016‐ Gabapentin
23
Ohio’s Automated Rx Reporting System –
Prescription Monitoring System
• HB93Mandatedthatalllicensingboardsmust
establishrulesgoverningtheuseofOARxRS by
theirlicensees– OSMB,OSBP,etc
• HB341Mandatedthatallprescribersmust
attestthattheyareregisteredwithOARxRS
inordertogettheirlicensesrenewed
24
12
11/7/2016
OARxRS
In2011:
OhioPopulationapproximately11million
ScriptsinOARRS:46.9million
#ofpatientsinOARRS:5.7million
Timetogetreport:98%within23seconds
5%5mins‐3hrsreportsavailable24/7
Lagtimeof1‐3daysfromdispensingofmedicationuntil
reportavailable
25
Provided Courtesy of the National Association of Boards of Pharmacy®.
13
11/7/2016
OARxRS
WhocanaccessOARRS?
•
Pharmacist– owncustomeronly
•
Physician– currentpatientonly
•
Physician’snonlicenseddesignees(HB93)
•
Individual– ownreport
•
Licensingboards– ownlicensee
•
Lawenforcement‐ onlyaspartofacertifiedactive
investigationofsuspecteddiversion,abuseordrugtrafficking
27
OARxRS
• Thereportisprivilegedhealthinformation(HIPPA),
notapublicrecord,notevidence
• Youmaynotsharetheinformationwithother
professionalsunlesstheyusesamechart
• Youmayshowthepatientthedatabutnotgiveitout
• Youmustkeepreportinnonreproduciblepartofchart
• YoumaynotuseOARRStoscreenemployeesor
potentialemployees
28
14
11/7/2016
OARxRS – How often must you access?
•
Beforeprescribing/dispensingthe1st doseofanopioid toapatient
Every90daysthatyoucontinuetoprescribe/dispenseopioids for
thatpatient
• Accessthedatafromstatesadjoiningthecountiesinwhichyou
practice
•
•
Everytimethereisa“REDFLAG”event
RedFlagevents??
DocumentinthecharteverytimeyouaccessOARxRS
29
OARxRS
Whenmustyouenterdata:
• Ifyoudispenseareporteddrugfromyour
office
• Donotneedtoreportinjections
• Donotneedtoreportifthepatientisexempted
(hospicepatientsandcancerrelatedpain)
30
15
11/7/2016
OARxRS
Exemptions‐ whendoyounothavetoaccess
OARxRS
• Scriptsforlessthan7dayssupply
• Patientswhoareonhospice
• Patientsinnursinghomes,residentialcare
facilities,hospitalizedpatients
• Cancerpainorpainrelatedtocancer
• BeforeprescribingGabapentin products
31
Signing up for OARxRS
GoogleOARxRS
Homepage– “Register”
‐ registrationtakesabout15minutes
Moreinformation– Questions??
614‐466‐4131option1
oarrsadmin@ohiopmp./gov
32
16
11/7/2016
Ohio’s Chronic Pain Law‐ 1998
( originally the Intractable Pain Law)
•
Providesadefinitionof“chronicpain”
•
RequiresthattheStateMedicalBoardadoptrulesestablishing
standardstobefollowedbyphysiciansinthediagnosisand
treatmentofchronicpain‐ completetextoftherulescanbefound
at:http://med.ohio.gov/rules/4731‐21.htm
•
Allowsaphysiciantotreatchronicpainwithappropriateamounts
orcombinationsofdrugs
Mandatesconsultationpriortomakingadiagnosisofintractable
pain
• Outlinesrequiredmedicaldocumentation
•
33
OSMB rules regarding documentation
•
•
•
•
•
Historyandphysicalexamination
Thediagnosisofchronicpain,includingsigns,
symptoms,andcauses
Theplanoftreatment,thepatient'sresponseto
treatment,andanymodificationtoplanoftreatment
Thepatient’snameandaddress,theamountsand
dosageformsofthedrugs,thedates,onwhichdrugs
wereprescribed,furnished,oradministered
Acopyofthereportmadebythephysicianorthe
physiciantowhomreferralforevaluationwasmade
underthisdivision.
34
17
11/7/2016
Chronic Pain Law/ OSMB Rules
ORC4731.052(D)Addressesfearofregulatoryscrutiny:
“Aphysicianwhotreatschronicpainbymanagingitwith
dangerousdrugsisnotsubjecttodisciplinaryactionby
theboardundersection4731.22oftheRevisedCode
solelybecausethephysiciantreatedtheintractablepain
withdangerousdrugs.Thephysicianissubjectto
disciplinaryactiononlyifthedangerousdrugsarenot
prescribed,furnished,oradministeredinaccordance
withthissectionandtherulesadoptedunderit.”
35
Ohio’s Opioid Laws
Ohio’s130th GeneralAssembly,
2013‐2014therewere17ormore
opioid billsintroduced– most
diedincommittee!
36
18
11/7/2016
Sub HB 341 ‐
ChronicPain:
Definitionof“12weeks”definescriteria
forcheckingOARxRS
Sub.HB341:Requiresthataprescriberbeforeprescribing
orpersonallyfurnishinganopioid analgesicor
benzodiazepinerequestpatientinformationfrom
OARRS,andifthetreatmentcontinuesformorethan90
daysrequirestheprescribertoaccessinformationin
OARRSatintervalsnot>90days
EffectiveApril15,2015
37
HB 170 ‐ Naloxone
• HB170Allowscertainlicensedprofessionals
toprescribe,administer,dispenseorfurnish
naloxone topatientsatriskofoverdoseorto
friendsorfamilyofthoseatrisk
38
19
11/7/2016
Ohio’s Opioid Laws
• SubHB314MinorPrescriptions‐ requires
prescriberstoobtainwrittenconsentbefore
prescribingacontrolledsubstancetoaminor–
EffectiveSeptember17,2014
‐ certainexceptionsapplyincludingsafety
concernsfortheyouthifparentsareawareof
theopioid prescription
39
Ohio’s Opioid Prescribing Guidelines
• DevelopedbytheGovernor’sCabinetOpioid
ActionTeam – 2012‐2015(GCOAT)
• Censusprojectofover30stakeholders
• CommissionedbyGovernorKasich,October,
2011
• “Aseatatthetable”– theOhioOsteopathic
Association‐ JonWills,ExecutiveDirector
40
20
11/7/2016
“If you’re not at the table,
!
you’re
on the menu”
‐
41
Ohio Emergency and Acute Care Facility Prescribing Guidelines: OOCS (opioids and other controlled substances)
PriortodecidingwhethertotreatwithanOOCS,ED
clinician:
_mustaccessOARRS
– CheckaphotoIDorphotographpatient
– mayperformadrugscreen
•
EDshouldconsidercontactingthepatient’sregularphysicians
•
RequestaPalliativeCareorpainconsult,orsubspecialtyservice
•
PerformcasemanagementonpatientsrepeatedlyseeninED
42
21
11/7/2016
Ohio Emergency and Acute Care Facility Prescribing Guidelines: • Requestmedicalandprescriptionrecords
• Requirethatthepatientsignapainagreement
outliningexpectationsoftheEDdepartmentregarding
painmanagement
• UseEMRtocommunicatewithotherprovidersabout
patient
• LimittheRxofOOCStoa3daysupply
43
Ohio Emergency and Acute Care Facility Prescribing Guidelines: • Dischargeinstructionswithinformationonaddiction
risk,dangersofmisuse,appropriatestorage/disposal
ofunusedmeds
• Facilitiesshouldmaintainalistofclinicsthatprovide
primarycareservicesandpainmanagement
• EDandotherfacilitiesshoulddisplaysignageof
theseprescribingguidelinesandstatementof
facilitypositiononprescribingofopioids andother
controlledsubstances
44
22
11/7/2016
Guidelines for Prescribing Opioids for the
Treatment of Chronic, Non-Terminal Pain
80 mg of a Morphine Equivalent Daily Dose (MED)
“Trigger Point” Protocol
• Pertainstopatientsreceivingopioids equaltoor
greaterthan80mgMEDdailyfor>90days
• Consideredtobea“PressPause“pointtoreconsider
thepatient’streatmentplanandwhetherasa
prescriberyouarefullycompliantwiththeaccepted
andprevailingstandardsofcare
80MED Daily Dose
Thisistheequivalentofabout:
16Vicodin perdayPO
10oxycodone IR(Percocet)perday
Oxycontin 30mg2dayPO
Fentanyl Patch37mc/hrtopicalpatches
Methadone???15mg/day??
46
23
11/7/2016
TheGuidelinesToolkit
1.Re‐establishInformedconsent,providethepatientwithwritten
informationontheadverseeffectsoflong‐termopioid therapy
2.
Reviewthepatient’sfunctionalstatusanddocumentation,
includingthe“4A’s”ofchronicpaintreatment‐ activitiesofdaily
living,
3.
Reviewthepatient’sprogresstowardtreatmentobjectives
4.
ChecktheOARRSreportagain
47
4 “A”s of Chronic Pain Treatment
1. ActivitiesofDailyLiving‐ Oswestry lowback
painquestionaire
2. Analgesia
3. Adverseaffects
4. Abberant behaviors:SBIRT,CAGE‐AID,
Opioid RiskTool
48
24
11/7/2016
Press Pause at 80MED daily dose
• Considerupdatingthepatientspaintreatment
agreement:considermorefrequentofficevisits,
differenttreatmentoptions,useofonepharmacy,a
drugscreen,consequencesofnoncompliancewiththe
termsoftheagreement‐ besurepatientisbeing
carefullymonitored
• Consideraspecialtyconsult
• Documenttheperformanceofa“presspause“
reviewatthe80MEDtriggerpoint
49
80 MED Daily Dose
Reviewthepatientsproblemlistandmed
sheet:
•
COPD?,Heartdisease?renalinsufficiency??
•
Othersedating/hypnoticdrugs– almostall
opioid prescriptionoverdosesinvolve
multiplesubstances!!!
•
Riskylifestylebehaviors– alcoholuse,
recreationaldrugs,marijuana,OTCmeds
50
25
11/7/2016
Ohio’s Guidelines for Management of Acute Pain Outside the ED‐ January, 2016
1Assessmentofthepaintoidentifyitsetiology,
determinewhetherthepainisofsomatic,
visceralorneuropathicoriginbasedonthe
patientsdescriptionofthepain,your
examinationanddiagnosticworkup
51
Acute Pain Guidelines
2.DevelopaPlan:
• Measureablegoalsforthereductionofthepain
• Useofbothnon‐pharmacologicand
pharmacologictherapieswithaclear
therapeuticpath
• Mutuallyunderstoodexpectationsforthe
degreeanddurationofthepainduringtherapy
• Goal:returntofunctionatbaselineratherthan
completeresolutionofpain
52
26
11/7/2016
Treatment of Acute Pain
3.Utilizenon–PharmacologicTreatment:ice
heat,bracing,splints,directedexercise,
massagetherapy,acupuncture,Osteopathic
neuromuscularcare
3.Non–opioid pharmacologictreatment:
Acetomeminophen,NSAIDS,Corticosteriods
Gabapentin,tricyclics,SNRIsmusclerelaxants,
others
53
Opioids for Acute Pain‐ how and when
• Appropriateriskscreening– consideraopioid risktool
• Prescribetheleastpotentopioid toeffectivelycontrol
•
•
•
•
thepain
Prescribetheminimalquantity/norefills
ConsidercheckingOARxRS priortoprescribing‐
requiredifprescribingfor7or>days
Avoidlongactingopioids
Caution:ifpatientisonothersedatingdrugs:
benzos,sleepers,orifpatientisknowntousealcohol
orrecreationaldrugs
54
27
11/7/2016
Opioids for Acute Pain
• Preplanaweanoffofopioids asthepain
resolves
• Discussproperstorageandsafetyofopioids in
thehome
• Discussimportanceofproperdisposalof
unusedmedications
• Remindpatientthatsharingisunsafeand
unlawful!!
55
Acute pain – What to do if pain persists
Ifpainpersists>14days:
• Reevaluateetiology
• Reevaluatethetreatmentmodalities
• Determinereasonforcontinuedpain
• Otherdiagnosticandmanagementstrategies
suchasaspecialtyconsultation
56
28
11/7/2016
Landmarks for Navigating the Waters in a Murky Sea
• Knowyourpatient– treatyourrealpatients
withrealpain
• Ifyoudon’ttrustthepatient‐ don’ttreat
• Utilizeabiopsychosocial modelofpain
management‐ almostallpainwilleithercome
withordevelopemotionalconnections–geton
topofthisearly
• Treatthepatientandnotthepain
57
Emotional distress and Pain
• Emotionaldistressalwaysresultswhenan
acutepainissevereenoughtobecome
chronic
• Thedevelopmentofemotionaldistress
associatedwithacutepainmaybearisk
factorforthedevelopmentofchronicpain
Waldman– pp207‐209
58
29
11/7/2016
Pain and emotional distress: Operant Conditioning
• Individualsbehaveincertainwaysaccordingto
reinforcementpatterns
• Forchronicpainpatientsmaladaptivepain
behaviorsareoftenbeingreinforcednegatively
andpositivelywhilewellbehaviorsarebeing
ignoredandextinguished
• Operantconditioninghasbeenshowntobe
effectiveforincreasingactivitylevels,exercise
andtolerance
59
Navigating the Waters
• Usereturntofunctionasthegoal– nota
reductioninapainnumber!
• Setrealistic,achievablegoals
• Withnewonsetpain– keepthepatientmoving
rightfromthestart!
• Utilizeneuropathicpainadjuvants whenever
treatingchronicpainandearlyinthecoarseof
treatingacutepainaswell
60
30
11/7/2016
Navigating the Waters
• UtilizeOARxRS – it’sagreattool
• KnowtheOSMBrulesandfollowthem
“TreatingPainisamoralimperative”
IOM2011
61
At the end of the day
“Physiciansneedtrainingandexperiencein
painmanagementifissuesofaccessandunder
treatmentaregoingtobeaddressed”
NationalPainCarePolicyActof2009IncorporatedintotheObama
HealthcareReformBill
TherealissueforprescribersinOhio’s
PainEpidemicisnotwhetherornotto
treatpainbuthow!
62
31
11/7/2016
At the end of the day
“SlowlyIlearnabouttheimportanceof
powerlessness.Iexperienceitinmyownlife,
andIlivewithitinmywork.Thesecretisnot
tobeafraidofit,nottorunaway.Patients
knowthatwearenotGod…Alltheyonlyaskis
thatwedonotdesertthem.”
Cassidy,S.Sharingthe
Darkness. London:Darton,
LongmanandTodd,1988
63
Thankyou!
Questions?
64
32
11/7/2016
References: The Chronic Pain Association
TheAmericanChronicPainAssociationhasoffered
supportandinformationforpeoplewithchronicpain
since1980.Itsmissionistofacilitatepeersupportand
educationforindividualswithchronicpainandtheir
familiessothattheseindividualsmaylivemorefullyin
spiteoftheirpain,andtoraiseawarenessamongthe
healthcarecommunity,policymakersandthepublicat
largeaboutissuesassociatedwithlivingwithchronic
pain.LearnmoreabouttheAmericanChronicPain
Associationatwww.theACPA.org.
65
References
•
AAFPMonograph:BalancingClinicalandRiskManagementConsiderationsfor
ChronicPainPatientsonOpioid Therapy,October,2008
•
OfficeofNationalDrugControlPolicyActionPlanepidemic:Respondingto
America’sPrescriptionDrugAbuseCrisis,2011
•
Veteran’sAffairs/DepartmentofDefense;ClinicalPracticeGuidelinesSummary
ManagementofOpioid TherapyforChronicPain,2010
•
Fishman,ScottMResponsibleOpioid Prescribing2ndedition,2014WaterfordLife
Sciences,Washington,DCwww.fsmb.org/books
•
med.ohio.gov/rules4731‐21htm
Twillman,BFromPolicytoPractice:“HowtheCDCGuidelinesPlayOutinPrimary
Care“presentedatAAPMAnnualMeeting,Sept21‐25,2016,SanAntonioTexas
•
66
33
11/7/2016
References
•
•
•
•
•
AAFPMonograph:BalancingClinicalandRiskManagement
ConsiderationsforChronicPainPatientsonOpioidTherapy,October,
2008
APS‐ AAPMClinicalGuidelinesforOpioidUseinChronicNonCancerPain
2009
Fishman,ScottM.ResponsibleOpioidPrescribing,2ndedition,Waterford
LifeSciences,2012pp1‐129
InstituteofMedicine:RelievingPaininAmerica,aBlueprintfor
transformingprevention,care,educationandresearch.ReportBrief,June
2011
OfficeofNationalDrugControlPolicyActionPlanepidemic:Responding
toAmerica’sPrescriptionDrugAbuseCrisis,2011
67
References
•
•
•
•
•
•
Reform.8.Availableat:
http://www.maydaypainreport.org/docs/A%20Call%20to%20Revolutionize
%20Chronic%20Pain%20Care%20in%20America.pdf
Shega,JW.etal.Theassociationbetweennoncancerpain,cognitiveimpairment
andfunctionaldisability J.GerontologySeriesA,65A(8)880‐886
TheMaydayFund.(2010).ACalltoRevolutionizeChronicPainCarein
America:AnOpportunityinHealthCare
Veteran’sAffairs/DepartmentofDefense;ClinicalPracticeGuidelines
SummaryManagementofOpioidTherapyforChronicPain,2010
Waldman,Steve,PainManagement,Vol1,Saunders,Philadelphia,2007212‐
221
Waldman,Steve,PainManagement,Vol2,Saunders,Philadelphia2007pp965‐
971,1003‐1009
68
34
Sample E-newsletter and Blast Email
Headlines/Subjects:
1—How Can OARRS Help You?
2—Help Improve Patient Care Using OARRS
3—Reduce Prescription Abuse Using OARRS
4—Prescribe Safely Using OARRS
How can Ohio’s Automated Rx Reporting System (OARRS) help you? It
can help you improve patient care, reduce prescription abuse, and
prescribe safely.
Are you registered for OARRS? If you are not using OARRS, you need to
start today (link words “start today” to
http://www.ohiopmp.gov/portal/registration/default.aspc)!
OARRS can help you:





Provide better patient care
Identify patients with potential drug seeking behaviors
Ensure that the patient’s drug therapy is appropriate
Comply with “press pause” clinical guidelines at 80 morphine equivalent dose (MED)
Demonstrate the effectiveness of clinical guidelines making adoption of prescribing rules
unnecessary.
The Time is Now!
On September 1 all of the state regulatory boards adopted clinical prescribing guidelines (link to
PDF – note: if you don’t have PDF you can download it here: http://www.ohioafp.org/wpcontent/uploads/Guidelines-for-Prescribing-Opioids-for-the-Treatment-of-Chronic-Non-TerminalPain.pdf) that became the standard of care in Ohio. Over the next 15 months, OARRS data will
be used to assess the impact of these guidelines.
Using the recently adopted 80 MED guidelines in coordination with OARRS reports is a best
practice that offers insight into a patient’s use of controlled substances while also alerting
prescribers to possible medication conflicts as well as signs of abuse, addiction or diversion.
OARRS reports have recently been enhanced to include a dosage calculator to assist
prescribers in determining whether patients are at, near or over the daily 80 MED.
Read more about OARRS (link to OAARS page on your website) and Ohio’s opioid prescribing
information (link to http://www.opioid.prescribing.gov).
Watch for more updates in (name and link to your e-newsletter).
State Medical Board of Ohio
30 E. Broad Street, 3rd Floor, Columbus, OH 43215-6127
(614) 466-3934
med.ohio.gov
Guidelines for Prescribing Opioids for the Treatment of Chronic, Non-Terminal Pain
80 mg of a Morphine Equivalent Daily Dose (MED) “Trigger Point”
May 9, 2013
These guidelines address the use of opioids for the treatment of chronic, non-terminal pain. "Chronic pain" means pain
that has persisted after reasonable medical efforts have been made to relieve the pain or cure its cause and that has
continued, either continuously or episodically, for longer than three continuous months. The guidelines are intended to
help health care providers review and assess their approach in the prescribing of opioids. The guidelines are points of
reference intended to supplement and not replace the individual prescriber’s clinical judgment. The 80 mg MED is the
maximum daily dose at which point the prescriber’s actions are triggered; however, this 80 mg MED trigger point is
not an endorsement by any regulatory body or medical professional to utilize that dose or greater.
Recent analysis by the Centers for Disease Control
and Prevention (CDC) shows that “patients with
mental health and substance use disorders are at
increased risk for nonmedical use and overdose
from prescription painkillers as well as being
prescribed high doses of these drugs.” Drug
overdose deaths increased for the 11th consecutive
year in 2010. Nearly 60% of the deaths involved
pharmaceuticals, and opioids were involved in
nearly 75%. Researchers also found that drugs
prescribed for mental health conditions were
involved in over half. These findings appear
consistent with research previously published in
the Annals of Internal Medicine that concluded
that “patients receiving higher doses of prescribed
opioids are at an increased risk for overdose, which
underscores the need for close supervision of
these patients” (Dunn, et al., 2010).
Health care providers are not obligated to use
opioids when a favorable risk-benefit balance
cannot be documented. Providers should first
consider non-pharmacologic and non-opioid
therapies. Providers should exercise the same
caution with tramadol as with opioids and must
take into account the medication’s potential for
abuse, the possibility the patient will obtain the
medication for a nontherapeutic use or distribute it
to other persons, and the potential existence of an
illicit market for the medication.
Providers must be vigilant to the wide range of
potential adverse effects associated with long-term
opioid therapy and misuse of extended-release
formulations. That vigilance and detailed attention
has to be present from the outset of prescribing and
continue for the duration of treatment. Providers
should avoid starting a patient on long-term opioid
therapy when treating chronic pain. Providers should
also avoid prescribing benzodiazepines with opioids
as it may increase opioid toxicity, add to sleep apnea
risk, and increase risk of overdose deaths and other
potential adverse effects.
Providers can further minimize the potential for
prescription drug abuse/misuse and help reduce the
number of unintentional overdose deaths associated
with pain medications by recognizing times to “press
pause” in response to certain “trigger points.” This
pause allows providers to reassess their compliance
with accepted and prevailing standards of care. The
80 mg Morphine Equivalent Daily Dose (MED)
“trigger point” is one such time.
To protect and enhance the health and safety of the public through effective medical regulation
State Medical Board of Ohio
Guidelines for Prescribing Opioids – 80 MED “Trigger Point”
2
Providers treating chronic, non-terminal pain
patients who have received opioids equal to or
greater than 80 mg MED for longer than three
continuous months should strongly consider doing
the following to optimize therapy and help ensure
patient safety:
 Reestablish informed consent, including
providing the patient with written information
on the potential adverse effects of long-term
opioid therapy.
 Review the patient’s functional status and
documentation, including the 4A’s of chronic
pain treatment:
o Activities of daily living;
o Adverse effects;
o Analgesia; and
o Aberrant behavior.
 Review the patient’s progress toward
treatment objectives for the duration of
treatment.
 Utilize OARRS as an additional check on patient
compliance.
The 80 MED “trigger point” is an opportunity to
review the plan of treatment, the patient's response
to treatment, and any modification to the plan of
treatment that is necessary to achieve a favorable
risk-benefit balance for the patient’s care. If opioid
therapy is continued, further reassessment will be
guided by clinical judgment and decision-making
consistent with accepted and prevailing standards of
care. The “trigger point” also provides an
opportunity to further assess addiction risk or
mental health concerns, possibly using Screening,
Brief Intervention, and Referral to Treatment (SBIRT)
tools, including referral to an addiction medicine
specialist when appropriate.
For providers treating acute exacerbation of chronic,
non-terminal pain, clinical judgment may not trigger
the need for using the full array of reassessment
tools.
Providers treating patients with acute care
conditions in the emergency department or urgent
care center should refer to the Ohio Emergency and
Acute Care Facility Opioids and Other Controlled
Substances Prescribing Guidelines at
http://www.healthyohioprogram.org/ed/guidelines.
 Consider a patient pain treatment agreement
that may include: more frequent office visits,
different treatment options, drug screens, use
of one pharmacy, use of one provider for the
prescription of pain medications, and
consequences for non-compliance with terms
of the agreement.
 Reconsider having the patient evaluated by one
or more other providers who specialize in the
treatment of the area, system, or organ of the
body perceived as the source of the pain.
Approved by Medical Board: May 9, 2013
Released January 2016
Ohio Guideline for the Management of Acute Pain Outside of Emergency Departments
Preface: This guideline provides a general approach to the outpatient management of acute pain. It is not intended to take the
place of clinician judgement, which should always be utilized to provide the most appropriate care to meet the unique needs of
each patient. This guideline is the result of the work from the Governor’s Cabinet Opiate Action Team (GCOAT) and the
workgroup on Opioids and Other Controlled Substances (OOCS).
Introduction
In 2014, 2,482 individuals in Ohio died from an unintentional opioidrelated overdose – more than a four-fold increase in 10 years1.
Unintentional opioid overdose has become one of the leading causes
of injury-related death in Ohio over the past decade. To respond to
this challenge, public health and health care leaders have committed
to helping healthcare providers better serve their patients with pain,
while reducing the potential for overdose and death. As part of the
Governor’s Cabinet Opiate Action Team (GCOAT), the workgroup on
Opioids and Other Controlled Substances (OOCS) was charged with
developing guidelines for the safe, appropriate and effective
prescribing of self-administered medications for pain. The two
previously released guidelines are:
•
•
Ohio Emergency and Acute Care Facility Opioids and Other
Controlled Substances Prescribing Guidelines [Released 2012;
Revised 2014]
Guidelines for Prescribing Opioids for the Treatment of Chronic,
Non-Terminal Pain 80mg of a Morphine Equivalent Dose (MED)
“Trigger Point” [Released 2013]
Purpose
This third guideline is focused on the management of acute pain and
the prescribing of self-administered medications for acute pain,
delineating a standardized process that includes key checkpoints
for the clinician to pause and take additional factors into
consideration.
Definition of Acute Pain
For this guideline, acute pain is defined as pain that normally fades
with healing, is related to tissue damage and significantly alters a
patient’s typical function. Acute pain is expected to resolve within
days to weeks; pain present at 12 weeks is considered chronic and
should be treated accordingly. This guideline may not apply to acute
pain resulting from exacerbations of underlying chronic conditions.
Assessment and Diagnosis of Patient Presenting with Pain
For assessing patients presenting with acute pain, in addition to a
proper medical history and physical exam, initial considerations
should include:
•
Location, intensity and severity of the pain and associated
symptoms
•
Quality of pain e.g. somatic (sharp or stabbing), visceral
(ache or pressure) and neuropathic pain (burning, tingling
or radiating)2
•
Psychological factors, including personal and/or family
history of substance use disorder
A specific diagnosis should be made, when appropriate, to facilitate
the use of an evidence-based approach to treatment.
Develop a Plan
Upon determining the symptoms fit the definition of acute pain, both
the provider and patient should discuss the risks/benefits of both
pharmacologic and non-pharmacologic therapy. The provider should
educate and develop a treatment plan together with the patient that
includes3:
•
Measureable goals for the reduction of pain
•
Use of both non-pharmacologic and pharmacologic
therapies, with a clear path for progression of treatment
•
Mutually understood expectations for the degree and the
duration of the pain during therapy
•
Goal: Improvement of function to baseline or pre-injury
status as opposed to complete resolution of pain
Treatment of Acute Pain
While these guidelines provide a pathway for the management of
acute pain, not every patient will need each option and care should
be individualized.
Non-Pharmacologic Treatment
Non-pharmacologic therapies should be considered as first-line
therapy for acute pain unless the natural history of the cause of
pain or clinical judgment warrants a different approach. These
therapies often reduce pain with fewer side effects and can be
used in combination with non-opioid medications to increase
likelihood of success. Examples may include, but are not limited
to:
•
Ice, heat, positioning, bracing, wrapping, splints, stretching
and directed exercise often available through physical
therapy
•
Massage therapy, tactile stimulation,
acupuncture/acupressure, chiropractic adjustment,
manipulation, and osteopathic neuromuscular care
•
Biofeedback and hypnotherapy
Non-Opioid Pharmacologic Treatment
Non-opioid medications should be used with non-pharmacologic
therapy. When initiating pharmacologic therapy, patients should
be informed on proper use of medication, importance of
maintaining other therapies and expectation for duration and
degree of symptom improvement. Treatment options, by the
quality of pain, are listed below.
Somatic Pain
•
Acetaminophen
•
Non-steroidal anti-inflammatory drugs (NSAIDS)
• Corticosteroids
Alternatives include the following: gabapentin/pregabalin,
skeletal muscle relaxants, serotonin-norepinephrine reuptake
inhibitors, selective serotonin reuptake inhibitors and tricyclic
antidepressants.
Visceral Pain
•
Acetaminophen
•
Non-steroidal anti-inflammatory drugs (NSAIDS)
• Corticosteroids
Alternatives include the following: dicyclomine, skeletal muscle
relaxants, serotonin-norepinephrine reuptake inhibitors, topical
anesthetics and tricyclic antidepressants.
Neuropathic Pain
•
Gabapentin/pregabalin
•
Serotonin and norepinephrine reuptake inhibitors
• Tricyclic antidepressants
Alternatives include the following: other antiepileptics, baclofen,
bupropion, low-concentration capsaicin, selective serotonin
reuptake inhibitors and topical lidocaine.
Opioid Pharmacologic Treatment
In general, reserve opioids for acute pain resulting from severe
injuries or medical conditions, surgical procedures, or when
alternatives (non-opioid options) are ineffective or contraindicated.
Short-term opioid therapy may be preferred as a first line therapy
in specific circumstances such as the immediate post-operative
period. In most cases, opioids should be used as adjuncts to
additional therapies, rather than alone.4 It is critical that
healthcare providers communicate with one another about a
patient’s care if the patient may be receiving opiate prescriptions
from more than one provider to ensure optimum and appropriate
pain management. The following are recommendations for the
general use of opioids to manage acute pain:
•
Appropriate risk screening should be completed (e.g. age,
pregnancy, high-risk psychosocial environment, personal
or family history of substance use disorder).
•
Provide the patient with the least potent opioid to effectively
manage pain. A morphine equivalence chart should be
used if needed.
•
Prescribe the minimum quantity needed with no refills
based on each individual patient, rather than a default
number of pills.
•
Consider checking Ohio Automated Rx Reporting System
(OARRS) for all patients who will receive an opiate
prescription. (Note: An OARRS report is required for most
prescriptions of seven days or more.)
•
Avoid long-acting opioids (e.g. methadone, oxycodone ER,
fentanyl).
•
Use caution with prescribing opioids with patients on
medications causing central nervous system depression
(e.g. benzodiazepines and sedative hypnotics) or patients
known to use alcohol, as combinations can increase the
risk of respiratory depression and death.
•
Discuss with the patient a planned wean off opioid therapy,
concomitant with reduction or resolution of pain.
•
Discuss proper secure storage and disposal of unused
medication to reduce risks to the patient and others.
•
Remind the patient that it is both unsafe and unlawful to
give away or sell opioid medication, including unused or
leftover medication.
Pain Reevaluation
Key Checkpoint: Reevaluation of patients who receive opioid
therapy for acute pain will be considered if opioid therapy will
continue beyond 14 days. This reevaluation may be through an
office visit or phone call based on the discretion of the provider.
For patients with persisting pain, providers should reevaluate the
initial diagnosis and consider the following:
• Pain characteristics (consider using a standardized tool
[e.g. Oswestry Disability Index])
• Treatment methods used
• Reason(s) for continued pain
• Additional management options, including consultation with
a specialist
Additional Checkpoint:
For patients with pain unresolved after 6 weeks, providers should
repeat an assessment and determine whether treatment should be
adjusted. Referral to guidelines on chronic pain management may be
helpful at this point, although chronic pain is defined as pain
persisting for longer than 12 weeks.
References:
1.
2.
3.
4.
ODH, Office of Vital Statistics, Analysis by Injury Prevention Program.
2013.
Institute for Clinical Systems Improvement. Assessment and management
of acute pain. Bloomington (MN): Institute for Clinical Systems
Improvement; 2008 Mar. 58p.
Massachusetts Medical Society Opioid Therapy and Physician
Communication Guidelines. May 21, 2015.
Washington State Agency Medical Directors Group. Interagency Guideline
on Prescribing Opiates for Pain Washington State Guidance. June 2015.
The Five Common Disorders of the Hand Seen by PCP’s
C. Jeff Kesler, M.D., FACS
Learning Objectives:
Identify the signs and symptoms of nerve compression syndrome.
Perform the physical exam for the five common hand disorders.
List necessary diagnostics for nerve compression syndrome.
Define treatments for the five common hand disorders.
11/1/2016
FRIDAY, NOVEMBER 11, 2016
NWOOA
ELEVENTH ANNUAL
PRIMARY CARE UPDATE
SANDUSKY, OHIO
DR. C. JEFF KESLER, MD
FACS
THE FIVE COMMON
DISORDERS OF THE HAND
SEEN BY PRIMARY CARE
PROVIDERS
1
11/1/2016
INTRODUCTIO
N
DR. C.
JEFF
KESLER,M
D FACS
INTRODUCTION
▸ COSMETIC RECONSTRUCTIVE SURGEON
▸ ARROWHEAD PLASTIC SURGEONS INC.
▸ UNDERGRADUATE EDUCATION AT YOUNGSTOWN STATE UNIVERSITY,
YOUNGSTOWN, OHIO
▸ POST GRADUATE EDUCATION AT MEDICAL COLLEGE OF OHIO IN
TOLEDO , OHIO
▸ POST GRADUATE TRAINING IN GENERAL SUGERY AT SWEDISH
HOSPITAL MEDICAL CENTER IN SEATTLE, WASHINGTON
▸ BOARD CERTIFIED GENERAL SURGEON
▸ POST GRADUATE RESIDENT IN PLASTIC RECONSTRUCTIVE SURGERY
AT MEDICAL COLLEGE OF OHIO IN TOLEDO, OHIO
▸ TRAINED UNDER DRS JOHN KELLEHER AND MICHEAL YANIK
▸ BOARD CERTIFIED PLASTIC RECONSTRUCTIVE SURGEON
2
11/1/2016
FELLOWSHIP TRAINING
▸ PLASTIC, COSMETIC AND
RECONSTRUCTIVE SURGERY
▸ HAND SURGERY
▸ HEAD AND NECK SURGERY
PRACTICING IN
TOLEDO, OHIO SINCE
1995 WITH
ARROWHEAD
PLASTIC SURGEONS
INC.
3
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MY TEAM
DAWN BURGE,
PATIENT CARE
COORDINATOR
MY TEAM
MONIQUE
NAVARRE
, RN
4
11/1/2016
THE FIVE COMMON
DISORDERS OF THE
HAND SEEN IN THE
PRIMARY CARE
1. NERVE COMPRESSION SYNDROMES
SETTING
(CARPAL, CUBITAL SYNDROME)
2. TRIGGER FINGER
3. DUPUYTREN’S CONTRACTURE
4. DEQUERVAIN’S SYNDROME
5. GANGLION CYST
OBJECTIVES
1. TO IDENTIFY THE SIGNS AND SYMPTOMS OF NERVE COMPRESSION
SYNDROMES, TRIGGER FINGER, DUPUYTRENS CONTRACTURE,
DEQUERVAINS SYNDROME AND GANGLION CYST.
2. TO PERFORM THE PHYSICAL EXAM FOR THE 5 COMMON HAND
DISORDERS.
3. TO LIST NECESSARY DIAGNOSTICS FOR NERVE COMPRESSION
SYNDROMES.
4. TO DEFINE TREATMENTS FOR THE 5 COMMON HAND DISORDERS.
5. TO DETERMINE WHEN IT IS NECESSARY TO REFER THE PATIENT TO
THE HAND/ PLASTIC SURGEONS FOR SURGICAL EVALUATION AND
TREATMENT.
6. TO DESCRIBE THE NORMAL POST-OPERATIVE COURSE FOR
PATIENTS WHO HAVE THESE SURGERIES.
5
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NERVE COMPRESSION
SYNDROMES
CARPAL TUNNEL
SYNDROME
CARPAL TUNNEL
SYNDROME
ICD-10 - G56.0
1. SIGNS AND SYMPTOMS
EPIDEMIOLOGY
2. CAUSES
REPETITIVE MOTION
ASSOCIATED CONDITIONS
3. DIAGNOSIS
PHYSICAL EXAM
‣ PHALEN’S MANEUVER
‣ TINELS SIGN
‣ DURKAN TEST,CARPAL COMPRESSION TEST
‣ HAND ELEVATION TEST
4. TESTING
EMG
MRI
6
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CARPAL TUNNEL
SYNDROME
5. PATHOPHYSIOLOGY
6. PREVENTION
7. TREATMENTS
SPLINTS
CORTICOSTEROIDS
SURGERY
OCCUPATIONAL HAND THERAPY
8. PROGNOSIS
7
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8
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9
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NERVE COMPRESSION
SYNDROMES
CUBITAL TUNNEL
SYNDROME
10
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CUBITAL TUNNEL SYNDROME
ICD-10 G56.2
1. SIGNS AND SYMPTOMS
2. CAUSES
3. DIAGNOSIS
MOTOR
SENSORY
MIXED
4. PREVENTION
CUBITAL TUNNEL
SYNDROME CONTINUED…
5. TREATMENT
CONSERVATIVE
SURGICAL
6. POST- OPERATIVE COURSE
7. PROGNOSIS
8. CUBITAL TUNNEL SYNDROME VERSUS GUYON’S CANAL
SYNDROME
11
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12
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13
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14
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TRIGGER
FINGER
TRIGGER FINGER
ICD-10 M65.3
1. SIGNS AND SYMPTOMS
2. CAUSES
3. TREATMENT
CORTICOSTEROID INJECTIONS
SURGERY
4. POST-OPERATIVE COURSE
5. PROGNOSIS
15
11/1/2016
16
11/1/2016
17
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DUPUYT
REN’S
CONTRA
CTURE
DUPUYTREN’S CONTRACTURE
ICD-10 M72.0
1. DEFINITION
2. SIGNS AND SYMPTOMS
3. ANATOMY
4. RISK FACTORS
18
11/1/2016
DUPUTRYEN’S
CONTRACTURE
5. TREATMENTS
CONTINUED…
RADIATION THERAPY
SURGICAL
AMPUTATION
INJECTIONS
6. PROGNOSIS
7. POST OPERATIVE CARE
19
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20
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XIAFLEX INJECTION
DE
QUERVAI
N’S
SYNDRO
ME
21
11/1/2016
DE QUERVAIN
SYNDROME
ICD-10 M65.4
1. SOCIETY AND CULTURE
2. SIGNS AND SYMPTOMS
3. PATHOPHYSIOLOGY
4. DIAGNOSIS
5. TREATMENT
CONSERVATIVE TREATMENT
SURGERY
OCCUPATIONAL HAND THERAPY
22
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FINKELSTEIN
TEST
23
11/1/2016
GANGLIO
N CYST
GANGLION CYST
ICD-10 M67.4
1. SIGNS AND SYMPTOMS
SITES
SIZE
2. CAUSES
3. DIAGNOSIS
RADIOLOGY
ULTRASOUND
24
11/1/2016
GANGLION CYST
CONTINUED…
4. TREATMENT
DO NOT HIT THE CYST WITH THE BIBLE!!
ASPIRATION
CORTICOSTEROID INJECTION
SURGERY
5. PROGNOSIS
RECURRENCE
SCAR FORMATION
25
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26
11/1/2016
QUESTI
ONS?
ASK ME
ANYTHING!
CONTACT INFORMATION
DR. C. JEFF KESLER, MD FACS
1360 ARROWHEAD ROAD
MAUMEE, OHIO 43537
DAWN BURGE, PATIENT CARE COORDINATOR
(419) 887-4507 M-TH
MONIQUE A. NAVARRE, RN
(419) 887-4526 M-TH
27
11/1/2016
28
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IT HAS BEEN MY
PLEASURE PRESENTING
AT THIS WONDERFUL
CONFERENCE
THANK
YOU FOR
HAVING
ME!
29
See Spot Change: Identification and Management in
Primary Care
Erin Hennessey, DNP, APRN, FNP-C
Learning Objectives:
Discuss malignant skin lesions commonly seen in primary care.
Identify common treatments and surgical procedures utilized for management.
Review criteria for referral to plastic surgery.
11/1/2016
See spot change:
Lesion identification
and management in
primary care
ERIN HENNESSEY DNP, APRN, FNP-C
Learning objectives

Discuss malignant skin lesions commonly seen in
primary care.

Identify common treatments and surgical
procedures utilized for management.

Review criteria for referral to plastic surgery.
1
11/1/2016
Commonly seen malignant skin
lesions in primary care.

1) Basal cell carcinoma

2) Squamous cell carcinoma

3) Melanoma
Non Melanoma and Melanoma
Skin Cancer

History and Physical

With evaluating lesions that may be non healing or present for an extended
period of time, it is helpful to obtain the following:


- Ethnicity and skin color (fair, olive, African American)
- Lifetime sun exposure (frequent vs. intermittent)

- History of sunburn as a child or adult

- Tanning bed use

- Smoking or chewing tobacco use

- Occupational exposure

- Immunosuppression or organ transplantation (renal transplant patients have a
253 fold increase in the risk for squamous cell carcinoma)

- History of radiation treatment for cancer or previous PUVA or UVA treatment
for psoriasis
2
11/1/2016
Basal Cell Carcinoma

Basal cell carcinoma is the most common invasive malignant
cutaneous neoplasm. It is traditionally diagnosed by clinical
identification and shave or scoop biopsy.

The most common presenting complaint is a bleeding or scabbing
sore that heals and recurs.

Although it will not metastasize, if left untreated it will advance by
direct extension and destroy normal tissue causing significant
damage.
Location, Epidemiology and
Pathogenesis

85% appear on the head and neck, 25 – 30% occur on the nose which is
the most common site for basal cell carcinoma.

20% of tumors occur on sites that are typically sun protected such as
the genitals and breasts.

The average lifetime risk for Caucasians to develop BCC is 30%

Individuals with fair skin, blonde or red hair, light eye color, poor tanning
ability and sun damaged skin are at the highest risk. Male to female
ratio is 2:1 with the exception being women under the age of 40. The
closer one lives to the equator, the greater their risk is for developing
BCC.

UVB plays a greater role in BCC development than UVA

Arise from basal keratinocytes of the epidermis and adnexal structures
(e.g., hair follicles and eccrine sweat ducts)
3
11/1/2016
Basal Cell carcinoma
Basal cell
carcinoma
Nodular Basal Call
Carcinoma
BCC
Inferior lateral canthus
Left cheek / side burn area
Note the rolled borders
BCC
4
11/1/2016
Squamous Cell Carcinoma

20% of all non melanoma skin cancers in the US are SCC (80% are BCC).
They arise from the epithelium and common in the middle aged and
elderly populations. Lifetime risk of 18 – 20% and rising.

Risk factors include exposure to sunlight during childhood, sunburns,
ionizing radiation, light skin, hazel, blue or green eyes, blond or red hair,
outdoor occupations, freckling, living in the south, previous psoriasis
therapy (oral psoralen and UVA radiation), and exposure to arsenic via
medication or drinking water.

UVB plays a major role in SCC. UVB damages DNA by inducing the
formation of pyrimidine dimers and induces mutation of p53 tumor
suppressor genes. These mutations are found in SCC lesions. Cell
mediated immunity and immune function may be modulated by UVB
as well. HPV virus 6 and 11 are found in genital tumors and HPV 16 in
periungual tumors. Diagnosis is made by shave or scoop biopsy.
Location, Epidemiology and
Pathogenesis

Most commonly found in sun exposed areas – scalp, backs of the hands
and the pinna – BCC is rarely found on these sites.

They may appear as flat, scaly lesions that indurate. Central crusting
and ulceration is common. They can develop a thick , warty
appearance on top. It is very common to see SCC of the mouth or lip in
smokers or those who use chewing tobacco.

Two major groups (based on malignant potential) A) Those arising in
areas of radiation or thermal injury, chronic draining sinuses, and in
chronic ulcers are typically aggressive and have a high frequency of
metastasis. B) Those originating from actinically damaged skin are less
aggressive and less likely to metastasize.

Patients who have undergone solid organ transplantation or who are
immunosuppressed need to be monitored closely for SCC. They can be
very aggressive in these patients.
5
11/1/2016
Management of Basal cell and
Squamous Cell carcinoma

Mohs procedure – micrographic surgery excellent in areas where
conservation of tissue is salient (e.g., inner or outer canthus of the eye, nasal ala,
vermillion border of the lip, fingers and ears. Benefits – excellent cure rate (up to
99%) Drawbacks - time consuming and expensive. There is a risk that the Moh’s
surgeon will be unable to close the wound that day and the patient will have to
find a plastic surgeon to close.

PDT – is FDA-approved for the treatment of superficial or nodular BCC.. A light-

Electrodesiccation and curettage - The technique may not be as useful for
aggressive BCCs, those in high-risk sites, or sites that would be left with
cosmetically undesirable results. Typically, a round, whitish scar is left at the
surgery site.
sensitizing agent, topical 5-aminolevulinic acid (5-ALA), is applied to the lesion in
the physician’s office. Subsequently, the medicated area is activated by a
strong blue light; theoretically, this will selectively destroy BCCs while causing
minimal damage to surrounding normal tissue Benefits - cure rates ranging from
70 to 90 percent Draw backs - . Some redness, pain, and swelling can result.
Patients must strictly avoid sunlight for at least 48 hours, or UV exposure may
further activate the medication, causing severe sunburn. Very time consuming.
Treatment of BCC and SCC
(cont’d)
Surgical excision - gold standard treatment in our office. If the lesion is
on the face, chest, shoulders, neck or lower extremities, referral to
plastic surgery is warranted due to the possible need for skin grafting in
these areas as well as an optimum aesthetic outcome for patients.
Benefits - histologic margin control and rapid healing, and minimal pain
Excellent cure rate with frozen section ( approx 99% in our office).
Drawbacks – requires a surgical procedure with anesthesia.
 BCC only:
 Erivedge (vismodegib) – oral capsule used to treat adults with multiple
BCCs, recurrent BCC or is not a candidate for surgery or radiation.
Pregnancy category X. Females are required to use two forms of birth
control for 7-8 months following treatment and Males may not donate
semen or impregnate their partner for 3 months due to the birth defect
risks associated. Benefit – no surgical procedure needed. Drawbacks –
side effects and challenging to use in women of child bearing age.

6
11/1/2016
Actinic Keratosis





Clinically, these can be felt most times before they are seen. They begin
as slightly rough textured skin and gradually an adherent yellow scale
forms as the skin inferior becomes more erythematous. They can be
biopsied, but most diagnoses are made based on clinical acumen.
Often these progress to thickened or hypertrophic lesions and often
times to squamous cell carcinoma.
The extent of the disease may vary from a single lesion to diffuse lesions
that most often present on the the forehead, balding scalp, temples
and sideburn areas.
Induration, erythema, pain, inflammation, ulceration and oozing are
suggestive of progression to malignancy.
Histologically is squamous cell carcinoma in situ confined to the
epidermis. It is very difficult to say where a lesion stops being an actinic
keratosis and begins to be SCC in situ because they are biologically the
same. They are on a continuum of disease
Actinic Keratosis
7
11/1/2016
Management – single lesions of
Actinic Keratosis

Cryotherapy – liquid nitrogen is applied to the area causing
separation of the dermis and epidermis. Benefits – highly specific
and in light skinned people is usually non scarring. Drawbacks – in
darker skinned folks, may cause hyperpigmentation.

CO2 laser resurfacing, dermabrasion and chemical peels. Benefits –
fast and may also soften lines and aesthetically improve the
appearance of skin. Drawbacks – not covered by insurance and
has a lower cure rate than topical therapies.

Electrodessication and Curettage

Surgical excision
Management of multiple or diffuse
actinic keratoses

Field Directed therapy –– total sun avoidance is recommended.

5-fluorouracil – topically applied chemotherapy agent Benefits – good
insurance coverage, can be done at home, does not harm healthy skin, can be
used over a larger surface area. Drawbacks – intense inflammation, erythema
and crusting, at possible risk for secondary infection, poor compliance.

Imiquimod – topical immune response modifier cream. Applied 3x per week for
16 weeks or 3x per week for 4 weeks, 4 weeks of drug holiday, then a second 3x
per week for 4 weeks. Can be reduced to 2x per week if there local skin
reaction. Benefits – reduction of 86.6% of Aks with 3.75% formulation. Drawbacks
– tricky prescription pattern for the patient to follow and possible issues with
compliance.

Picato (ingenol mebutate) – plant based (Euphorbia puplus) from Australia –
once daily for 2-3 days. Creates the same inflammatory response as other
topical chemotherapy agents with clearance in 2 weeks. Benefits – compliance
(2-3 days!) Drawbacks – side effects and no long term studies available yet.
8
11/1/2016
Management of multiple or diffuse
actinic keratoses (con’t)

PDT – photo dynamic therapy – topical chemotherapy provides
much better histologic response

Diclofenac (Solaraze) – BID for 60 – 90 days – great placebo control
studies in transplant patients out of Germany: a complete
clearance of AK lesions was achieved in 41% (9/22) compared to
0% (0/6) in the vehicle group. At 24 months 55% of the patients had
recurrent AKs but there were 0 SCC within the group.
Malignant Melanoma

Malignant melanoma is a cancerous neoplasm of pigment forming
cells, melanocytes, and nevus cells.

Clinically it’s hallmarks are: irregularly shaped and pigmented patches,
papules or plaques.

Melanoma can arise from a preexisting lesion or de novo. There is no
difference in the survival rate, but melanoma arising from a pre-existing
lesion is more commonly found on the trunk, in younger individuals, and
is more likely to be superficial spreading

The earlier melanoma is diagnosed the better the changes of complete
surgical eradication.

Down and dirty - New research shows that having more than 11 nevi
on one arm can indicate a increased risk for melanoma and patients
can be appropriately advised to follow up with yearly skin exams
9
11/1/2016
Melanoma

Cutaneous melanoma types:
Superficial
spreading melanoma
Nodular melanoma
Acral lentiginous melanoma
Lentigo maligna melanoma
Epidemiology and Pathogenesis

Melanoma is the fifth most common cancer in men and the sixth
most common cancer in women.

1 in 50 Americans will develop melanoma in their lifetime For
historical perspective, in 1935, the risk was 1 in 1500. The majority of
melanoma in the US is diagnosed in the 15 – 50 year old age group.

Patient with acute, episodic exposures to sunlight have a greater
chance of developing melanoma than those with continuous
exposure in either adulthood, adolescence or via occupational
exposure.
10
11/1/2016
ABCDEs of identifying
characteristics.

A– asymmetry

B – Border irregularity

C – Color variegation

D – Diameter > 6mm or approximately the size of a pencil eraser

E – Evolution or change

Lesions can be red, white, blue, have notched borders or a papule
or nodule within it.

Ugly duckling rule – 10% of melanoma do not follow the traditional
rules. When a patient presents with any pigmented lesion that
appear different from other nevi, it should be biopsied.
Malignant Melanoma
11
11/1/2016
Melanoma of the
Lip
Superficial spreading melanoma

70% of ALL cutaneous melanoma

Location: Most commonly found on the trunks of men and the
extremities of women (questionable correlation with intermittent sun
exposure)

Asymmetrical presentation with variation in color and border
irregularities are common

Papular or nodular component to the lesion may suggest a deeper
invasion

Can arise from preexisting moles
12
11/1/2016
Nodular melanoma

Nodular melanoma comprises 9-20% or invasive melanoma

Occurs most often in the fifth or sixth decade and more often in
men than women 2:1

It does not conform to the usual pattern – is it occasionally flesh
colored and resembles a flesh colored nevi or basal cell carcinoma.
It is most frequently misdiagnosed as a blood blister, hemangioma,
nevus, seborrheic keratosis or dermatofibroma.

They have rapid growth patterns and tend to ulcerate.
Lentigo Maligna Melanoma

4 – 15% of melanomas

Located on the head, neck, arms and sun damaged skin

Slow growing: 5 – 20 years

Most commonly presents in the sixth or seventh decade

Clinically appears as a brown to black or blue to black nodule
13
11/1/2016
Acral lentiginous melanoma

2 – 7% found in Caucasians

30 – 75% of melanomas in African American, Asian and Hispanic

Located on the palms or soles as well as within the proximal nail fold
Squamous Cell carcinoma
invasive
Squamous cell
carcinoma
Squamous cell
carcinoma
Squamous cell carcinoma
In situ
Of the lower right lip
14
11/1/2016
Management of melanoma

A punch biopsy is performed and lesions are micro staged by a
pathologist. If there is extension to the border, a wider excision is
indicated. Breslow thickness, ulceration status, mitotic rate,
peripheral and deep margin status, anatomic level of invasion and
tumor infiltrating lymphocytes are all factored into the staging
process.

Surgical margins for invasive melanoma should be at least 1 – 2 cm
clinically measured around the primary tumor.

The decision to perform sentinel node biopsy is based on clinical
staging. Pathologic stage 0 – IA do not routinely need node biopsy.
In the pipeline
Sunscreen – Scientists out of Yale have developed a method for
encapsulating padimate O creating a bio adhesive nano particle that
adheres to the stratum corneum and does not absorb into the skin. It is
water resistant, but comes off with towel friction.
Field treatment for actinic keratosis - Low-dose 5-FU/SA is an effective
and well-tolerated treatment option licensed for the lesion-directed
treatment of mild-to-moderate hyperkeratotic AK lesions and currently
under investigation for field-directed treatment.
Europe has developed guidelines for the treatment of actinic keratosis
recently and I expect the US to adopt similar guidelines in the next
couple years.
15
11/1/2016
Take home points
If you suspect a non melanoma skin cancer on evaluation, shave or
scoop biopsy is appropriate. For a suspected melanoma or pigmented
nevus biopsy, punch is recommended to obtain Breslow thickness which
better predicts prognosis.
 Encourage all patients to utilize chemical free sunscreen. Benefits of
wearing chemical containing sunscreen outweigh the risk of damage
from UVA and UVB rays in the absence of a better option. SPF 30 – 50 is
recommended. Any SPF below 12 will prevent burn, but provide no
protection against UVA / UVB radiation.
 Follow up for patients who have AKs or have had BCC or SCC treated
should be evaluated once yearly with a full body skin exam. Patient’s
with a history of melanoma should be evaluated with a full body skin
exam every 3 months for the first year then every 6 months or yearly
there after.
 Patient’s who have greater than 11 nevi on one arm on physical exam
should be advised to obtain once yearly skin checks.

References

Bradford PT, Goldstein AM, McMaster ML, Tucker MA. Acral lentiginous melanoma: incidence and
survival patterns in the United States, 1986-2005. Arch Dermatol. 2009 Apr;145(4):427-434. doi:
10.1001/archdermatol.2008.609.

Claas Ulrich, Antje Johannsen, Joachim Röwert-Huber, Martina Ulrich, Wolfram Sterry, Eggert
Stockfleth Skin Cancer Centre Charité, Department of Dermatology, Charité Universitätsmedizin,
Charité-Platz 1, 10117 Berlin, Germany

Deng, Y., Ediriwickrema, A., Yang, F., Lewis, J., Girardi, M., & Saltzman, W. M. (2015). A Sunblock
Based On Bioadhesive Nanoparticles. Nature Materials,14(12), 1278–1285.
http://doi.org/10.1038/nmat4422

Habif, T. P. (2004). Clinical dermatology: A color guide to diagnosis and therapy. Edinburgh:
Mosby.

Lin, W. M., Luo, S., Muzikansky, A., Lobo, A. C., Tanabe, K. K., Sober, A. J., & ... Duncan, L. M. (2015).
Outcome of patients with de novo versus nevus-associated melanoma. Journal Of The American
Academy Of Dermatology, 72(1), 54-58. doi:10.1016/j.jaad.2014.09.028

Marks, J. G., Miller, J. J., Lookingbill, D. P., & Lookingbill, D. P. (2006). Lookingbill and Marks'
principles of dermatology. Philadelphia, PA: Saunders Elsevier.

Ribero, S., Zugna, D., Osella-Abate, S., Glass, D., Nathan, P., Spector, T. and Bataille, V. (2016),
Prediction of high naevus count in a healthy U.K. population to estimate melanoma risk. Br J
Dermatol, 174: 312–318. doi:10.1111/bjd.14216

Werner RN, Jacobs A, Rosumeck S, Erdmann R, Sporbeck B, Nast A. Methods and Results Report Evidence and consensus-based (S3) Guidelines for the Treatment of Actinic Keratosis International League of Dermatological Societies in cooperation with the European Dermatology
Forum. J Eur Acad Dermatol Venereol. 2015;29(11):e1-66.

http://cms.sagepub.com/content/early/2016/07/19/1203475416659259
16
Plastic Surgery Overview for the PCP
A. Thomas Dalagiannis, M.D. FACS
Learning Objectives:
Discuss what the sub-specialty of plastic surgery encompasses.
Discuss the basics of burn care and when to refer.
Recognize which procedures may be self-pay vs insurance coverage.
Common Pediatric Sightings
Tracy A. Karolyi, D.O., FACOP
Learning Objectives:
Distinguish between various pediatric skin conditions.
Distinguish between viral and bacterial skin condition.
Identify visually common pediatric dermatologic conditions
10/31/2016
Tracy Karolyi, D.O., F.A.C.O.P.
1
10/31/2016
 Aka:
Exanthema subitum, sixth disease.
 Caused by human HSV-6 or 7.
 Usually between ages 6mo-2yrs.
 Sudden high fever for few days, followed by
rash.
 Rash begins on trunk and spreads
peripherally.
 Common etiology for febrile seizures.
 Treatment is supportive.
2
10/31/2016
First Line Treatment: Penicillin
Second Line Treatment: Macrolides or Cephalosporins
 Other symptoms:
abdominal pain, swollen glands
headache
rashes – scarletina
Why do we treat?
* Peritonsillar abscess
* Rheumatic heart disease
* Glomerulonephritis


Can an infant get strep???
 Testing
should generally not be performed in
children younger than 3 years in whom GAS
rarely causes pharyngitis and rheumatic fever
is uncommon.
 In children and adolescents, negative RADT
tests should be backed up by a throat
culture; positive RADTs do not require a
back-up culture.
Shulman ST, Bisno AL, Clegg HW, et al. Clinical practice
guideline for the diagnosis and management of group A
streptococcal pharyngitis: 2012 update by the Infectious
Diseases Society of America. Clin Infect Dis. 2012;55(10):e86–
102
3
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4
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 Types:
morbilliform
exanthematous
urticarial
serum sickness
Treatment:
Stop offending agent
Antihistamine for pruritus
Steroids for severe reactions
 Penicillin
is most widely stated drug allergy
by patients (5-10% report)
 Although, 85-90% of those who report a PCN
allergy either aren’t allergic or allergy has
resolved.
 PCN IgE antibodies decrease over time,
therefore more recent reactions are more
likely to be true
 50% will lose sensitivity by 5 years
 80% will lose sensitivity by 10 years
 2% cross reaction with Cephalasporin
5
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©2016 UpToDate®
6
10/31/2016
 Chronic
and recurrent.
 Most commonly develops between infancy
and age 12.
 Neurodermatitis: itch-scratch-rash-itch cycle
 Can be localized or generalized
 Treatment consists of antihistamines,
hydration, topical anti-inflammatory agents
(corticosteroids).
7
10/31/2016
 Enterovirus
family
 Either Coxackie A or B with 24 serotypes
 Coxackievirus A16 most common
 3-7 day incubation period
 Seen more in summer and fall
 May have only rash or may have
constitutional symptoms of fever, headache,
malaise
 Treatment is supportive
8
10/31/2016
9
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 Newer
strain seen summer of 2012 in US
 Previously only seen in Africa and Asia
 More widespread, maculopapular rash or
vessicles and scabbing
 Carries higher risk for serious illness
 Rash mimics HSV eruption
 Nailbed disruption of fingers and toes.
 Significant skin peeling may occur.
10
10/31/2016
 Etiology
unknown
 Longterm – weeks to months
 Usually asymptomatic
 Firm, dermal papules in annular arrangement
 Usually isolated lesions
 May be pruritic
 Commonly misdiagnosed as tinea corporis
 No treatment generally, however, can put
high potency steroid creams topically or
intradermally for cosmetic reasons
11
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12
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 Benign
and self-limiting
 Occurs in up to 50% of newborn infants
 Lesions begin 24-48 hrs. after birth
 Can come and go for up to 2 weeks
 Smear
from pustule reveals: eosinophils
13
10/31/2016
14
10/31/2016
 Likely
caused by infectious agent.
 “herald patch” presents first and commonly
mistaken as an eczema patch or tinea.
 May or may not be pruritic.
 Spontaneous remission in 6-12 weeks or less.
 Treatment is to control pruritus.
 More severe cases may respond to UV light.
15
10/31/2016
 Rapidly
developing, bright red nodule
 Recurrently bleeds when touched
 Caused by proliferation of capillaries.
 Seen on fingers, lips, mouth, trunk, face.
 Common at prior sites of trauma.
 Doesn’t spontaneously disappear, must be
removed.
 Depending on location- derm or plastics.
16
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17
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 Etiology:
infectious, drug induced,
idiopathic.
 Rash can be widespread.
 May be pruritic.
 If develops mucous membrane involvement
then becomes EM Major aka: Stevens Johnson
Syndrome.
 Hadn’t
had antibiotics for 12 days.
 No other constitutional symptoms.
 Had developed a nagging cough and was
more fatigued.
 Labs
??
18
10/31/2016
 CBC-D,
EBV, Mycoplasma ordered
 IgG and IgM Mycoplasma both positive
 Treatment:
Remember: Did not finish Amox so strep not
effectively treated. Also need to treat the
mycoplasma.
Zithromax 6/kg daily for 5 days.
19
10/31/2016
 Unknown
eitiology.
 Self-limiting.
 1-2 mm, vesiculopustules or ruptured
pustules which disappear in 24-48 hours.
Leaves a collarette of scale.
 Wright stain shows neutrophils.
 Differential DX:
*toxicum
*staph
*HSV
20
10/31/2016
 Infection
of eyelid or skin surrounding the
eye.
 Most common under age of 6yr.
 Occurs most usually after a scratch or bug
bite in the periorbital region.
 Most common bacteria implicated:
- Staph aureus
- Strep pyogenes
- H. flu
Aggressive treatment to prevent…..
21
10/31/2016
 Rapid
swelling of the dermis, subcutaneous
tissue or mucosa
 Swelling can be itchy and painful
 Treatment if localized is antihistamines and
cool compresses.
Secondary to a wasp sting to bottom lip
22
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
HISTORY ??
23
10/31/2016
 Caused
by minor hemorrhaged capillaries.
 Most commonly caused by physical trauma,
ie: coughing, vomiting, crying.
 This young lady was in marching band and
rash began after a marching competition.
Remembers her feet being extremely wet
and cold.
 If petechiae more widespread and associated
with systemic symptoms then need to
consider vasculitic or infectious processes.
24
10/31/2016
 Psuedocysts
 Painless
swelling of connective tissue due to
ruptured salivary glands, usually secondary
to local trauma.
 Most commonly located on surface of lower
lip, buccal mucosa, ventral surface of tongue
or floor of mouth.
 Usually are <1 cm in diameter, smooth
walled, and bluish or translucent
 May resolve spontaneously, if remains chronic
then surgical resection necessary
25
10/31/2016
 Hairless,
well circumscribed, skin colored or
yellowish plaque on scalp.
 Due to overgrowth of sebaceous glands.
 Small percentage can give rise to secondary
neoplasms: basal cell or sebaceous
carcinoma
 Derm referral as teen for close observation
and decision to excise.
26
10/31/2016

History ??
 Patient
was seen 2 weeks prior in Urgent
Care and diagnosed with Group A Strep
 Treated appropriately with Amoxicillin
27
10/31/2016
Erythematous, tender nodules on pretibial
surface.
 Hypersensitivity reaction in the subcutaneous fat
tissues.
 30-50% of cases unknown etiology.
 May be secondary to infectious processes ie.
Mycoplasma, Group A strep, Hepatitis C, EBV.
 May be result of medications ie. OCP’s, sulfas
 Self-limiting resolving in 3-8 wks.
 Treatment is supportive and focuses on
underlying cause.
 Bedrest, elevation of legs, NSAIDS.

28
10/31/2016
 Aka-
pityriasis versicolor.
 Multiple, oval, scaly lesions.
 Hypo or Hyperpigmented.
 Usually located on upper back, neck,
proximal extremities. Rarely on face.
 Caused by fungus: Malassezia globosa or
furfur.
 Can definitively diagnose by KOH prep or
lesions may fluoresce under woods lamp.
 Treatment: selenium sulfide shampoos (RX
strength), ketoconazole, Ciclopirox (Loprox)
 Vitiligo
– won’t have the fine scale and there
is complete de-pigmentation.
 Pityriasis
Alba- lesions predominantly occur
on the face and less commonly on the trunk
and upper extremities. Will also have a fine
scale.
29
10/31/2016
 Major
clinical manifestations:
^ palpable, purpuric rash
^ arthralgias or arthritis
^abdominal pain: colicky ~ 50%
GI bleed ~ 20-30%
^renal disease: some form of renal
involvement in ~20-50%
30
10/31/2016
 routine
blood tests (ex CBC-D, serum
chemistries, and urinalysis) are nonspecific.
 Renal involvement often becomes detectable
after other manifestations of HSP, so urinary
screening should be continued beyond the
acute presentation.
 Most typically will find proteinuria or
hematuria.
 Abdominal US if severe abdominal pain
31
10/31/2016
A
form of impetigo in which the vesicles
enlarge to form bullae with clear yellow
fluid.
 After bullae rupture, a thin brown crust
forms.
 Due to a staph aureus that produces an
exfoliative toxin A.
 Treatment should target s.aureus
32
10/31/2016
TREATMENT:
1. Empiric oral antibiotic therapy with activity
against MRSA is particularly important
2. Clindamycin and TMP-SMX are antibiotics of
choice. (comparable treatment)
3. Parenteral antibiotic therapy — warranted if
^Extensive soft tissue involvement
^Signs of systemic toxicity
^Rapid progression of clinical manifestations
^ Persistence or progression of symptoms after
48 to 72 hours of oral therapy
^Immunocompromise
33
10/31/2016
 Parvovirus
B19
 Widespread clinical findings depending on
age of patient.
 25% children asymptomatic, 50% will have
non-specific flu like symptoms/fever, 25%
will have rash and arthralgias.
 Incubation period of 1-3 wks.
 Facial rash followed by lace like extremity or
body rash several days later.
 Treatment: supportive
34
Angioedema
Todd Rambasek, M.D., FAAAAI
Learning Objectives:
Differentiate among the various causes of urticarial and angioedema.
Develop the skills to decide which patients need allergy testing.
Recognize the signs of hereditary angioedema.
10/14/2016
Angioedema
TODD RAMBASEK M.D. FAAAAI
Angioedema

Swelling due to vascular leak caused by vasoactive
mediators
 Histamine
induced
 Bradykinin
Induced

Histaminergic is identified by response to high dose
antihistamine treatment.

Bradykinin induced diagnosed by lack of response to
antihistamines.
1
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Edema
Orolabial Angioedema
2
10/14/2016
Angioedema - subtypes
 Histaminergic


Idiopathic histaminergic angioedema

Allergic angioedema (foods – medications – latex – insect)

Physical urticaria/angioedema (cold – vibratory – pressure)
Bradykinin mediated

ACE Inhibitor induced

Idiopathic non-histaminergic angioedema

Hereditary angioedema types 1 & 2

Acquired C1-esterase inhibitor deficiency
12 y.o. girl presents with recurrent lip swelling and
abdominal pain that does not respond to
antihistamines. She has a paternal uncle who died of
laryngeal asphyxiation and her C4 level is 4 (14-40
mg/dl). What test will confirm her diagnosis?
A.
CH50
B.
Skin testing for food allergens.
C.
SPEP
D.
Flow cytometry
E.
C1 inhibitor level
3
10/14/2016
Hereditary Angioedema

Autosomal dominant disease caused by deficiency
of C1-esterase inhibitor (type 1) or poor function of
C1-esterase inhibitor (type 2)

Recurrent non-pruritic angioedema without hives.

May have prodromal erythema marginatum which
can mimic hives.

50% of patients present by age 10.
4
10/14/2016
Hereditary Angioedema
Erythema Marginatum
Patienthelp.org
5
10/14/2016
Hereditary Angioedema

Attacks may be triggered by minor trauma,
medical procedures, estrogen, or ACE I or be
spontaneous.

May involve face, throat, hands, feet, abdomen,
genitals.

Unnecessary surgery is a common historical feature.

GI attacks may cause bowel obstruction.
Hereditary Angioedema

50% of patients may experience laryngeal
attacks at some point.

Historical data suggests that 30% of patients
died from asphyxiation.

Any patient may have a laryngeal attack
anytime.
6
10/14/2016
HAE – Laboratory Diagnosis

C4 complement level is low during attacks and
asymptomatic periods.

Sensitivity of C4 test is 95% and so may be used
for screening.

C1 inhibitor antigenic level will be low in HAE I

C1 inhibitor functional level will be low in HAE I
and HAE II
HAE – Acute attacks

Epinephrine, antihistamines, are steroids and not
effective in treating acute attacks  bradykinin
mediated.

FFP may help – or worsen.

C1 inhibitor replacement therapy

Kallikrein inhibitor (ecallantide)

Bradykinin receptor antagonist – (icatibant)
7
10/14/2016
8
10/14/2016
HAE – Short Term Prophylaxis

Needs to be given prior to medical procedure
especially dental (not routine cleaning).

C1 INH several hours before procedure

Attenuated androgens 7 days before until 2 days
afterword.

Emergency therapy on hand.
HAE – Long Term Prophylaxis

Patients who experience repeated attacks should
be placed on long term prophylaxis.

Daily C1 inhibitor – requires IV access every 3 days.

Danazol – effective and well tolerated but may
have virilizing effects.

Tranexemic acid – generally less effective and may
have thrombotic side effects.
9
10/14/2016
Acquired C1 inhibitor Deficiency

Patients present exactly like HAE but at an older age.

Very rare.

The cause is usually B cell lymphoma.

Previously divided into 2 types (I – autoantibody & II
Lymphoma related) but these are now thought to be
greatly overlapping.

C4 – low – C1 INH low – C1q low.
HAE with normal C1 Inhibitor

By 2000 – 10 families described with 36 women – no men –
with recurrent angioedema including airway compromise
and normal C1 INH.

Was initially termed HAE III.

Subsequently other kindreds found with male probands.

Some of these patients found to have a mutation in Factor
12 (XII HAE). Some however do not (U-HAE).

Often have a pharmacologic response to bradykinin
inhibiting drugs.
10
10/14/2016
55 y.o. man on an ACE I for 6 yrs has severe tongue
and lip swelling without hives and is drooling. There
is no response to antihistamines or steroids. Which is
true?
A.
He is likely to respond to epinephrine.
B.
He is likely to tolerate an ARB.
C.
Asphyxiation is rare with ACE angioedema.
D.
ACE I is not the cause as he has been on it for 6 years.
E.
There is no drug treatment for ACE I angioedema.
ACE Inhibitor Angioedema

Angiotensin converting enzyme is involved in the
breakdown of bradykinin.

Angioedema occurs in 0.5% of patients on ACE I
but is more common in African Americans, women,
and smokers. Diabetics are relatively protected.

Latency of onset can vary from several hours to
several years.
11
10/14/2016
ACE Inhibitor Angioedema

Usually localizes to the face and lips – deaths
have been reported.

GI angioedema may also occur and lead to
obstructive symptoms.

May recur up to 6 weeks after stopping the drug.

Bradykinin mediated
ACE Inhibitor Angioedema
12
10/14/2016
ACE Inhibitor Angioedema - Treatment

27 patients with ACE I induced angioedema
randomized to icatibant 30 mg SC or prednisolone
and clemastine.

Median time to resolution of symptoms was:
 Icatibant
– 8 hours
 Prednisolone/clemastine

– 27 hours
$ 11,328.94 per dose
NEJM 2015 Jan
ACE Inhibitor Angioedema – ARB’s

98% of patients with ACE I angioedema will
tolerate an ARB.

However because ARB’s are reported to cause
angioedema the risk benefit ratio should be
carefully weighed before giving these
medications.
13
10/14/2016
26 y.o. woman presents with 20 episodes of swelling
of the lips, hands, and feet for 6 months.
Occasionally associated hives. Not aware of a
food or medication trigger. Family history negative.
Mostly better with cetirizine. Which is correct?
A.
Order C4 level to rule out hereditary angioedema.
B.
Skin testing for common food allergens.
C.
Reassure and treat with cetirizine 20 mg B.I.D.
D.
C1 inhibitor level to rule our hereditary angioedema.
E.
Cetirizine 20 mg B.I.D. and epinephrine pen.
Idiopathic (histaminergic) Angioedema

Common condition that may mimic hereditary
angioedema or ACE I.

Differentiated by:
 Lack
 No
of family history
ACE use
 Less
severe episodes
 Response
to antihistamines
 Presence
of hives (not always present)
14
10/14/2016
Idiopathic (histaminergic) Angioedema
 How
do we know it’s not occult allergy?.
 Autologous
 Isolation
studies
 Anti-FcER1
auto-antibody
 Associated
 No
serum skin test
with Hashimoto’s thyroiditis.
associated wheeze, hypotenstion, GI symptoms
 History
negative
Idiopathic (histaminergic) Angioedema

Take a careful history.
Sex
 Foods

 Medications

NSAIDS
 Latex

ACE I
 Stings

Antibiotic creams/ointments
 Suppositories

Heat/Cold
15
10/14/2016
Idiopathic (histaminergic) Angioedema
Typical
regimen
1.
Cetirizine 20 mg B.I.D. (or loratidine)
2.
Ranitidine 150 mg B.I.D. (or famotidine)
3.
Montelukast 10 mg qd
4.
Hydroxyzine 100 mg qhs
34 y.o. man has shrimp at 6:00 p.m., goes to bed
at 10:00 pm and wakes at 7:00 am with swelling of
the lips but no other symptoms of allergic
reaction. We can tell him that 99% of food allergy
reactions occur within:
A. 2
B.
hours
3 hours
C. 4
hours
D. 6
hours
E.
8 hours
16
10/14/2016
IgE Mediated Food Allergy

99% occur within 2 hours

95-97% involve:
 Peanut/tree
nut
 Egg
 Milk
 Soy
 Seafood
IgE Mediated Food Allergy

90% of food reactions involve something on the skin
(hives, flush, and angioedema)

Do not result in chronic abdominal symptoms

To differentiate from idiopathic angioedema – food
allergy will have:

Wheeze or chest tightness

Low BP

Consistent food trigger within 2 hours

Rapid resolution in 4-6 hours
17
10/14/2016
Bradykinin Mediated Angioedema
Presentation
Diagnosis
NO hives
• C4 and C1 inh
Face, hands, throat, Low
GI
• Family History
• After minor trauma
•
Treatment
•
•
HAE
•
•
Acquired C1
Esterase
Deficiency
Older age
• B Cell Lymphoma
typical cause
•
Face/Lips/tongue
• May occur up to 6
wks after stopping
•
Ace Inhibitor
•
•
C1 inh, C4, and
C1q all low
Clinical
C1 inh
replacement
Kallikrein
inhibitor
Bradykinin
Antagonist
(icatibant)
• Stop
medication
tolerate ARB
• Consider icatibant
• 98%
Janean Wedeking DO
Histamine Mediated Angioedema
Presentation
• Wheeze,
Allergic IgE
Low BP, chest
tightness
• < 2 hours (99%)
• Skin manifestations (90%)
•
Testing based
on clinical history
Treatment
• Allergy
• Avoidance
• Compatible
• High
• Epinephrine
Pen
Peanut, egg, milk, soy, seafood (9597%)
• Mimics
Idiopathic
Diagnosis
• +/-
HAE, less severe
hives
history
C4
• Responds to
antihistamines
• Normal
dose H1 and H2
+ montelukast
Janean Wedeking DO
18
10/14/2016
A Challenging Case – Slide 1

T.F. is a 26 y.o. woman with a history of systemic lupus
erythematosis who presented to the CCF ED on June 15th, 2003
with the chief complaint of throat swelling and difficulty
breathing.

Earlier that day, while undergoing hemodialysis and after taking
tylenol she had complained of pain and tingling in her hands
and then later on that day began feeling swelling in her throat.
This then progressed to difficulty swallowing. When she arrived
in the ED she was having SOB and her speech was ‘garbled’.
A Challenging Case – Slide 2

In the ED she was given diphenhydramine, solumedrol,
pepcid, and clindamycin. She was then taken to the OR
emergently where she was intubated under direct
fiberoptic visualization. Fiberoptic exam by an
otolaryngologist showed ‘mostly supraglottic swelling with a
diffuse boggy epiglottis.’
19
10/14/2016
A Challenging Case – Slide 3
 T.F.
has had a few episodes of facial swelling in the past.
One of them was shortly after she was given piperacillin
and was attributed to PCN allergy. She does not recall
ever having hives with these events which in general have
been few and far between. She has never had an episode
this severe.
A Challenging Case – Slide 4
 Patient
was intubated and admitted to MICU where exam
notes a thick tongue, 2/6 systolic murmur and Quinton
dialysis catheter. History of SLE w/ ESRD, HIT, endocarditis,
anti-phospholipid antibody syndrome, depression,
mitral regurgitation, DVT with IVC filter placement,
multple line infections, mitral regurgitation, cellulitis,
pericardial effusion, strongyloidiasis.
20
10/14/2016
A Challenging Case – Slide 5
 Patient
born in Brazil, adopted to Cleveland and no known
family history of angioedema. Labs show a C4 level of 4
(16-64). Because of low C4 level patient was placed on FFP
around the clock and danazol and had improvement and
was extubated and sent to medical floor. Working
diagnosis at this point is C1 inhibitor deficiency.
A Challenging Case – Slide 6
 However
24 hours after going to medical floor patient has
recurrent angioedema of face, neck, and tongue and is
reintubated. C1 inhibitor antigenic and functional level
return as normal. Diagnosis is now unclear.
 Follow
up phone discussion showed persistent symptoms in
spite of use of danazol. Patient’s mother noted that
patient had symptoms of persistent facial swelling for as
long as one month.
21
10/14/2016
Given this extensive medical
history – the best test to clarify the
diagnosis at this point would be:
A. C1-Q
B.
auto-antibody level
Food allergy testing
C. Lip
biopsy of the facial swelling
D. SPEP
E.
CT of chest - neck
22
10/14/2016
SVC Syndrome
23
10/14/2016
SVC Syndrome

Facial and head swelling which results from
compression of the SVC – most often from
bronchogenic carcinoma.

Symptoms include shortness of breath, headache,
facial swelling, and venous distention of the neck.

May have a positive Pemberton’s sign (facial swelling
and cyanosis with raising the arms.)

SVC stenting may relieve the symptoms as was the
case for this patient.
24
NOTES
_________________________________________________
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_________________________________________________
_________________________________________________
_________________________________________________
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_________________________________________________
SATURDAY, NOVEMBER 12, 2016 9.0 credits
7:30 a.m.-7:55a.m.
Registration/Breakfast - West Pathway
Moderator:
Nicholas G. Espinoza, D.O. 8:00 a.m.-9:00 a.m.
Issues in Pain Management
Ajith K. Pai, M.D., FACA, DABA
9:00 a.m.-10:00 a.m.
Workplace Issues Associated with Legalized Medical Marijuana
Sarah E. Pawlicki, Esq., SPHR, SHRM-SCP
10:00 a.m.-10:30 a.m.
Break /View Exhibits - West Pathway
10:30 a.m.-11:30 a.m.
Prescribing Naloxone and Management of Chronic Non-Cancer Pain
Gregory Kramp, PharmD, RPh
11:30 a.m.-12:30 p.m.
Risk Evaluation and Mitigation Strategies (REMS) for
Extended-Release and Long-Acting Opioids
James E. Preston D.O., FAODME
12:30 p.m.-12:45 p.m.
Lunch Buffet (lunch and Learn)
Moderator:
Jennifer Pfleghaar, D.O.
12:45 p.m.-1:45 p.m.
Risk Evaluation and Mitigation Strategies (REMS) for
Extended-Release and Long-Acting Opioids
James E. Preston D.O., FAODME
1:45 p.m.-3:45 p.m.
Osteopathic Manipulation in a Busy Practice
Robert J. Cromley, D.O.
3:45 p.m.-4:00 p.m.
Break/View Exhibits – West Pathway
4:00 p.m.-6:00 p.m.
Drugs in America 2016
Robert M. Stutman & Judge Jodi Debbrecht Switalski
Issues in Pain Management
Ajith K. Pai, M.D., FACA, DABA
Learning Objectives:
Review management of chronic pain patients
Discuss opiate epidemic: Why/what physicians can do.
Recognize new Ohio State rules, guidelines and policies regarding
Opiate prescriptions.
Define opiate withdrawal treatment options
Workplace Issues Associated with Legalized
Medical Marijuana
Sarah E. Pawlicki, Esq., SPHR, SHRM-SCP
Learning Objective:
Discuss Ohio’s Amended HB 523 legalizing medical marijuana and its impact on
Ohio’s workforce and comparing it to the other states with legalized marijuana.
Discuss the practical implications of medical marijuana in the workplace.
Navigate the impact of medical marijuana on drug free workplace policies.
10/31/2016
Workplace Issues Associated with Legalized Medical Marijuana
Presented by
Sarah E. Pawlicki, Esq., SPHR, SHRM‐SCP
Legalized Marijuana
WWW.EASTMANSMITH.COM
1
10/31/2016
Ohio’s Support of Legalized Medical Marijuana
• What percentage of Ohioans support legalization of Medical Marijuana?
– March, 2016 Quinnipiac Poll – March, 2015 Quinnipiac Poll
– February, 2014 Quinnipiac Poll
WWW.EASTMANSMITH.COM
Federal Law and Marijuana
• Marijuana continues to be classified as a Schedule I drug under the Federal Controlled Substances Act – August 11, 2016 DEA declines petition to reclassify
• No currently accepted medical use • Lack of accepted safety for use under medical supervision
• High potential for abuse
WWW.EASTMANSMITH.COM
2
10/31/2016
Amended H.B. 523 – September 8, 2016
• Legalizes medical marijuana
• Establishes the Medical Marijuana Control Commission
• Physicians may recommend and must keep a log of the recommendations and why MJ was recommended over other drugs
• No home growing
• Minors must have consent of parent or guardian
WWW.EASTMANSMITH.COM
Amended H.B. 523
• Employers are allowed to refuse to hire, discharge, or discipline because of an employee’s use, possession, or distribution of medical MJ
• Drug free workplace policies enforceable
• Just cause for discharge for unemployment purposes
WWW.EASTMANSMITH.COM
3
10/31/2016
Qualifying Medical Conditions
• Acquired immune deficiency syndrome; • Alzheimer's disease; • Amyotrophic lateral sclerosis; • Cancer; • Chronic traumatic encephalopathy; • Crohn's disease; • Epilepsy or another seizure disorder; • Fibromyalgia; • Glaucoma; •
•
•
•
•
•
•
•
•
•
•
Hepatitis C;
Inflammatory bowel disease; Multiple sclerosis; Parkinson's disease; Positive status for HIV; Post‐traumatic stress disorder; Sickle cell anemia; Spinal cord disease or injury; Tourette's syndrome; Traumatic brain injury; Ulcerative colitis
WWW.EASTMANSMITH.COM
Qualifying Medical Conditions
• Pain that is either of the following:
– Chronic and severe;
– Intractable.
• Any other disease or condition added by the state medical board under section 4731.302 of the Revised Code.
WWW.EASTMANSMITH.COM
4
10/31/2016
Medical Marijuana Control Program
• Dept. of Commerce and State Board of Pharmacy must establish:
– Licensure of medical marijuana cultivators, processors, and retails dispensaries
– Registration of patients and caregivers
– Licensure of labs that test medical marijuana
• State Medical Board
– Issue certificates to physicians seeking to recommend • Rules must be adopted within 1 year and the program fully operational in 2 years
WWW.EASTMANSMITH.COM
Medical Marijuana Advisory Committee
•
•
•
•
•
•
•
Curtis L. Passafume, Jr., R.Ph. (Chair), practicing pharmacist and member of the State of Ohio Board of Pharmacy.
Stephanie M. Abel, Pharm.D., practicing pharmacist.
James “Ted” Bibart, representing patients.
Tony E. Coder, Jr., representing persons involved in the treatment of drug and alcohol addiction.
Michael G. Hirsch, representing agriculture.
Sheriff John Lenhart, representing local law enforcement.
Jason Kaseman, representing labor.
•
•
•
•
•
•
•
Martin McCarthy, Jr., representing caregivers.
Dr. Jerry W. Mitchell, Jr., practicing physician. Nancy Walsh Mosca, CNP, practicing nurse.
Marcie Seidel, representing persons involved in mental health treatment.
Dr. Amol Soin, practicing physician and member of the State Medical Board of Ohio. Michael E. Stanek, representing employers.
Gary L. Wenk, engages in academic research.
WWW.EASTMANSMITH.COM
5
10/31/2016
Permissible forms and methods
•
•
•
•
•
•
Oils;
Tinctures;
Plant material;
Edibles;
Patches;
Any other form approved by the state board of pharmacy under section 3796.061 of the Revised Code.
WWW.EASTMANSMITH.COM
But… No smoking!
• With respect to the methods of using medical marijuana, all of the
following apply:
(1) The smoking or combustion of medical marijuana is prohibited.
(2) The vaporization of medical marijuana is permitted;
(3) The state board of pharmacy may approve additional methods
of using medical marijuana, other than smoking or combustion,
under section 3796.061 of the Revised Code.
• Any form or method that is considered attractive to children, as
specified in rules adopted by the board, is prohibited
WWW.EASTMANSMITH.COM
6
10/31/2016
Affirmative Defense
• How much? Not more than a 90‐day supply
• To establish a physician must have written a recommendation certifying:
–
–
–
–
A bona‐fide physician‐patient relationship exists
Patient diagnosed with a qualifying medical condition
Physician requested an OARRS report
Physician informs the patient that the benefits outweigh the risks
• Also gives defense to parent/guardian or caregiver
WWW.EASTMANSMITH.COM
But… No driving
• This section does not authorize a registered patient to operate a vehicle, streetcar, trackless trolley, watercraft, or aircraft while under the influence of medical marijuana.
WWW.EASTMANSMITH.COM
7
10/31/2016
Medical Marijuana at Work
• Casias v. Wal‐Mart (6th Cir. 2012) Michigan Medical Marihuana Act did not prohibit employer from terminating employee for testing positive for marijuana despite the employee having a registered marijuana card because it did not regulate private employers.
WWW.EASTMANSMITH.COM
Medical Marijuana at Work
• Coats v. DISH Network (CO Supreme Court, June 15, 2015) CO law does not prohibit employers from terminating employees for positive test even where there is no impairment and employee is lawfully using medical marijuana because marijuana use is not “lawful” under federal law. WWW.EASTMANSMITH.COM
8
10/31/2016
Medical Marijuana at Work
• Braska v. Challenge Manufacturing (MI Court of Appeals, 2014) Employee discharged for positive drug screen entitled to unemployment benefits if the employee has a medical marijuana card and was compliant with MI law.
WWW.EASTMANSMITH.COM
Change in the wind…
• State of CT v. CT Employees Union Independent
WWW.EASTMANSMITH.COM
9
10/31/2016
Legal Issues Associated with Drug Testing
• Drug testing ≠ medical test under ADA
• ADA does not require marijuana use as a
“reasonable accommodation”
WWW.EASTMANSMITH.COM
MJ and Workers’ Compensation Claims
• Positive post‐accident drug screen ≠ denied workers’ compensation claim
• R.C. 4123.54 and the “rebuttable presumption”
• Voluntary abandonment for violation of written work rule
WWW.EASTMANSMITH.COM
10
10/31/2016
Questions?
Sarah E. Pawlicki, Esq., SPHR, SHRM-SCP
419-247-1701
[email protected]
www.eastmansmith.com
419-241-6000
11
Prescribing Naloxone and Management of Chronic Non
Cancer Pain
Gregory Kramp, PharmD, RPh
Learning Objective:
Identify patients who would benefit from naloxone.
Recognize legal and clinical issues in prescribing naloxone.
Describe overdose and its management.
Describe evidence based treatment of chronic non-cancer pain.
Describe evidence based treatment of addiction.
10/31/2016
Prescribing Naloxone & Management of Chronic Non‐
Cancer Pain
By Greg Kramp, PharmD., RPh.
11/12/2016
Statement of Disclosure
• I have no relevant financial relationships.
• I work for a retail pharmacy chain that just began dispensing naloxone through a protocol.
1
10/31/2016
Objectives
At the completion of this program, participants should be able to:
• Identify who would benefit from naloxone.
• Recognize legal and clinical issues in prescribing naloxone.
• Describe an overdose and its management.
• Describe treatment of chronic non‐cancer pain.
• Describe treatment of addiction.
http://www.cdc.gov/drugoverdose/data/statedeaths.html
24
Overdose Rate
18
18 %
Increase from ‘13 to ‘14
13%
4th
National Rank
18th
2
10/31/2016
Epidemiology
• 50 million in the USA have chronic pain2
• 2015: 3.8 million live with opioid abuse / dependence. 329K are addicted to heroin3
– 12.8% Misuse Rx opioids4
• 18,893 deaths due to rx opioid overdose4
– 2,482 in Ohio ‘ 14
Rudd, R. Increases in Drug and Opioid Overdose Deaths — United States, 2000–
2014. MMWR. January 1, 2016 / 64(50);1378‐82. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6450a3.htm
3
10/31/2016
Economic Impact
• Pain is a $560 ‐ 635 billion problem5,6
• Non‐medical use of rx opioids $72 billion problem7
– $15.9 B are costs related to overdoses
Clinical Risk Factors of Opioid‐Induced Respiratory Depression and Opioid Overdose8
• Hx of substance abuse
• Hx of mental illness
• Use of long acting opioids
• Switching to another opioid
• Morphine equivalent > 20mg/day
• Use of BZDs or alcohol
• Start/stop of 3A4 inhibitors
• COPD or asthma
• Sleep apnea
• Reduced kidney or liver fxn
• Skin ulcers
• Pancreatitis • Traumatic injury
4
10/31/2016
Vital Signs: Overdoses of Prescription Opioid Pain Relievers --- United States, 1999--2008
November 4, 2011 / 60(43);1487-1492. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6043a4.htm#tab1
National Overdose Deaths: http://www.drugabuse.gov/related‐topics/trends‐
statistics/overdose‐death‐rates
30,000
25,000
20,000
15,000
10,000
5,000
0
1999
2000
2001
2002
Prescription Drugs
2003
2004
2005
2006
2007
2008
Opioid Pain Relievers
2009
2010
2011
Illicit Drugs
2012
2013
2014
Heroin
5
10/31/2016
Anatomy and Physiology
• Normal rate: 12 – 20 breaths/min9
• Controlled by Hypoxic reflex10
– Medulla • μ and δ opioid receptors inhibit 11
– Baroreceptors in the aortic and carotid arteries
• μ opioid receptors inhibit11
– ↑ respiratory rate and depth
• pH, O2, CO2
Etiology11
• Taking prescribed medication with alcohol or other sedative
• Worsening lung function, kidney, liver fxn
• Start / stop of 3A4 inhibitor: fluconazole
• Adulterated heroin (fentanyl)
• Abuse / misuse
6
10/31/2016
Pathophysiology12
• RR < 10 / min
• Opioids bind to the mu receptor
–
–
–
–
↓response to CO2
↓ O2 levels
↓depth of respira on
↓ pharyngeal tone  ↑ upper airway resistance
• ↑Heart rate and cardiac output
• Similar morphine equilvent dosing similar respiratory depression10
• Tolerance to respiratory depression slower than analgesia Signs and Symptoms13
•
•
•
•
•
Pinpoint pupils
Low shallow breathing
Unable to wake person with sternal chest rub
Stupor
Diminished oxygen saturation SpO2< 92%15
13) Washington Manual. 32nd Edition. 2007 14) http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3739053/
7
10/31/2016
Diagnosis13
• Hx: ingestion of multiple meds is common
– Seek to identify drugs ingested
• Clinical presentation: Check vitals signs, pupillary rxns, neurologic rxns.
• Lab studies: ABGs, electrolytes, acid‐base gaps, baseline liver and kidney fxn, pregnancy test, EKG
• No need to get opioid levels
Differential Diagnosis 14
• Alcoholic Wernicke‐Korsakoff’s syndrome
– 100mg thiamine IVP
• Hypoglycemia
– 50% dextrose in NS 50mL IV
– Oral glucose paste
• Carbon Monoxide – Oxygen
• Benzodiazepine overdose
– Flumazenil
• May cause seizures 8
10/31/2016
Treatment 14
•
•
•
•
Goal: respiration depression w/o withdrawal
ABCs
IV access
Gastric Lavage – activated charcoal if with in 1 hour of ingestion
– Emesis contraindicated
• NAC for acetaminophen if needed
• Whole bowel irrigation
– body packers or fentanyl patch
• Naloxone 2mg to 10 mg
– High doses for diphenoxylate, buprenorphine, pentazocine
Naloxone
•
•
•
•
Competitive μ opioid receptor antagonist
Onset: with in 2 minutes 16
Duration: 20 ‐ 90 minutes 15
Dosage 17: Titrate dose to arousal – then 2/3rds of this dose / hour
15) Edward W. Boyer, Management of Opioid Analgesic Overdose
Engl J Med. 2012 Jul 12; 367(2): 146–155. doi: 10.1056/NEJMra1202561
16) Evzio PI Rev. April 2012
17) Goldfrank L, Weisman R, Errick J, Lo M. A dosing nomogram for continuous infusion of intravenous naloxone. Annals of Emergency Medicine. 1986;15:566‐570.
9
10/31/2016
Edward W. Boyer, Management of Opioid Analgesic Overdose
Engl J Med. 2012 Jul 12; 367(2): 146–155. doi: 10.1056/NEJMra1202561
Special Populations
• Pregnancy category B – crosses placenta
• Nursing mothers: unknown if present in milk
• Neonates and Pediatrics: usually require higher doses
• Geriatric: unknown / no changes seen
• Limited Effect with partial or mixed agonist / antagonists
16) Evzio PI Rev. April 2012
10
10/31/2016
Side Effects14: Narcan and OD
•
•
•
•
•
•
Hyper / Hypotension
Irritability
Anxiety
Restlessness
Nausea / vomiting
Cardiac arrhythmia
Arrhythmia
Renal failure
Rhabdomyolysis
Compartment Syndrome
• Pulmonary edema
•
•
•
•
Treatment
Product
Sig
NDC
Evizo® 0.4 mg/0.4 ml
Use one auto‐
injector upon signs of opioid overdose. Call 60842‐0030‐01
911. May repeat ×1 after 3 minutes.
Billing Qty
How Supplied
0.8 mL*
2 injections + 1 trainer
11
10/31/2016
Product
Sig
NDC
Naloxone 2 mg/2 ml Spray one‐half of syringe into each nostril upon signs of 4ml ( 2 opioid 76329‐3369‐01 syringes)
overdose. Call 911. May repeat x 1 after 3 minutes
Use as directed Dispense with 2 McKesson ID: for naloxone atomizers
2580348
administration
Billing Qty
2 atomizers†
How Supplied
2 syringes / box
25 atomizer / box
12
10/31/2016
13
10/31/2016
Product
Sig
Naloxone 0.4 mg/ml 10mL
Naloxone 0.4 mg/ml single dose vial, 2 vials
Naloxone 0.4 mg/ml single dose vial, 2 vials
BD 3mL 23 g x 1in Syringe
Product
NDC
Billing Qty
How Supplied
00409‐1219‐01
10 mL (1 vial)
25 multi‐dose vials / case
Inject 1 ml IM upon signs of opioid overdose. Call 00409‐1215‐01
911. May repeat ×1 after 3 minutes. 67457‐0292‐02
2 mL (2 vials)
10 single‐dose vials / box
2 mL (2 vials)
Use as directed for naloxone 08290‐3095‐71
administration
2 (2 syringes)
100 / case
NDC
Billing Qty
How Supplied
2
1 box of 2 ready
to use nasal sprays.
Sig
Use 1 spray in 1 Narcan Nasal nostril as Spray 4mg / needed may 0.1mL
repeat after
69547‐0353‐02
14
10/31/2016
Laws
• OH: through physician protocol
– Someone at risk or caregiver or friend or police officer
– One‐stop shop on www.pharmacy.ohio.gov : Protocol, patient handout, guidance document • MI: so far police have it
– Working on rx thru protocol law
15
10/31/2016
Narcan by Protocol: What Patients Get
• Verbal and written education required
– Call 911
– Overdose: Risk factors, how to prevent, signs / symptoms, how to respond
– Info on naloxone: how to use, store, expiration
– Where to get a referral for substance abuse tx
– Now at: CVS, Drug Mart, Giant Eagle, Kroger, Meijer, Rite Aid, Walgreens • 65% of all retail pharmacies
Identify and talk with our high‐risk patients:
1) Previous opioid intoxication or overdose. 2) History of nonmedical opioid use. 3) Initiation or cessation of methadone or buprenorphine for opioid use disorder treatment. 4) Higher‐dose (>50 mg morphine equivalent/day) opioid prescription. 5) Patients who may have difficulty accessing emergency medical services (distance, remoteness).
6) Voluntary request from a family member, friend, peace officer or other person in a position to assist an individual who there is reason to believe is at risk of experiencing an opioid‐related overdose
7) Receiving any opioid prescription plus: 16
10/31/2016
Receiving any opioid prescription plus:
a. Rotated from one opioid to another because of possible incomplete cross‐tolerance. b. Smoking, COPD, emphysema, asthma, sleep apnea, respiratory infection or other respiratory illness. c. Renal dysfunction, hepatic disease, cardiac illness or HIV/AIDS. d. Known or suspected concurrent alcohol use. e. Concurrent benzodiazepine or other sedative prescription. f. Concurrent antidepressant prescription.
Naloxone Laws
OH
Yes
Yes
Yes
Yes
Yes
Yes
‐‐
Yes
Yes
‐‐
Yes
MI
Yes
‐‐
‐‐
Yes
‐‐
‐‐
Yes
‐‐
Yes
Yes
Yes
Standing order
3rd Party
Possession w/o Rx
Distribution
Criminal
Civil
Disciplinary
Criminal
Civil
Disciplinary
Immunity: Dispensers
Criminal
Civil
State
Immunity: Prescribers
Lay distribution Immunity: Lay & Prescribing administrator possession permitted
Yes
Not
Yet
OH: HB 170 (2014); HB 4 (2015) MI: MI Comp. Law: 691.1503 & 333.17744b
Davis, Corey, JD. Legal Interventions to Reduce Overdose Mortality Naloxone Access & Overdose Good Samaritan Laws. The Network for Public Health Law. https://www.networkforphl.org/_asset/qz5pvn/network‐naloxone‐10‐4.pdf
17
10/31/2016
Guidelines
• WHO, AMA, VA: Those likely to witness an OD should have access to Narcan. – (Strongly recommended / opinion)
• WHO: No preference to dosage form – (Recommendation based on cost / opinion)
Pain Management ‐ CDC
• Non‐opioids are preferred – Exercise, SSRI, SNRI, TCAs, anticonvulsants, CBT
•
•
•
•
•
•
Opioids when benefits out‐weigh risks
Tx Goals and plan to stop if benefits not seen
Initially lowest effective dose of IR opioid
Recheck w/ dose ↑ ≥ 50mg Morphine / day
Avoid BZDs when possible
Recheck every 3 months (urine screen yearly)
18
10/31/2016
Neuropathic Pain ‐ IASP
1st line: Neurontin (gabapentin), Lyrica (pregabalin), Cymbalta (duloxetine), Effexor (venlafaxine), TCAs (amitriptyline) (desipramine) 2nd line: Lidoderm (lidocaine), Ultram (tramadol), Qutenza (capsaicin 8%)
3rd line: Opioids, Botox (botulinum toxin A)
Lancet Neurol. 2015;14(2):162‐73
Pain Assessment
• PEG: Pain, Enjoyment, General Activity
• PHQ‐9: depression scale
• ORT, SOAPP(‐R): Opioid Risk Tools
– Low Level of evidence
• 4 As: Analgesia, Activities of daily living, adverse effects, aberrant drug behavior
• Patient education: E.g. https://theacpa.org/
19
10/31/2016
April 1st 2015 OARRS for Physicians • Before prescribing opioids or benzodiazepines
– Previous 12 months / every 90 days / documented
• Exceptions
– Hospice or terminally ill
– If for 7 days or less
– Tx of cancer or condition associated with cancer
– Tx in hospital, LTC, nursing patient
– Tx of acute pain from pregnancy, surgery, invasive procedure OARRS for Pharmacists
Outpatient scripts only
All controlled substances
New drug, directions, strength Every 12 months
MD or pt outside of area
More than 1 prescriber (not same office)
Your judgment: early refill, intoxicated, “Percs”
20
10/31/2016
Opioid Use Disorder – DSM‐5
• Mild, moderate, or severe
• Inability to control or reduce use
• Interferes with major obligations or social fxn
– DSM5.org Medication Assisted Treatment (MAT)
• Methadone, buprenorphine, naltrexone
• Allows addicts to fxn
– Prevent relapse, reduce Hep C & HIV transmission www.samhsa.gov
Suboxone Preferred
• If suspect a lower tolerance to opioids (opinion)
• If concurrent heavy or unstable use of sedating drugs/medication(uncontrolled intervention)
• If elderly (opinion)
• If significant respiratory illness (opinion)
• Subutex preferred over methadone in pregnancy
• Ceiling effect for respiratory depression
21
10/31/2016
Source: www.hhs.gov/sites/default/files/factshee
t‐opioids‐061516.pdf
New Treatments
• Suboxone Docs: 1st year: 30→ 2nd 100→ 3rd 275 patients ‐ CNPs & PAs coming soon • FDA approves Probuphine® – buprenorphine implant
• Each implant supplies 8mg/day for 6 months
• Max 1 year of tx: once in each upper arm
• Vivitrol (Naltrexone)
– Every month in the glut for EtOH or opioids
– After withdrawals & in counseling
www.hhs.gov/sites/default/files/factsheet‐opioids‐061516.pdf ®http://probuphine.com/prescribing‐info www.vivitrol.com
22
10/31/2016
What Works & Doesn’t
• PDMP – no evidence of deaths prevented
• OARRSa
– 11.6% decrease in opioid scripts
– 71% decrease in MD shopping
• Abuse deterrent meds decrease useb
– Oxycontin less 42%
– Opana less 68% a: http://www.logandaily.com/news/opioid‐doses‐prescriptions‐for‐ohio‐patients‐
continue‐to‐decrease/article_6852f902‐9b7f‐5daf‐a7ac‐182973a8d1f8.html b: http://www.radars.org/portals/1/newsletters/2013q3‐radars‐system‐newsletter.pdf
Works (cont.)
• Methadone
– 2.5% taper off successfully – 12 – 52 weeks better vs. < 12 weeks
• Slower taper is more effective
Source: Defining dosing pattern characteristics of successful tapers following methadone maintenance treatment: Results from a population‐based retrospective cohort study. Addiction. 2012 Sep; 107(9): 1621–1629.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3376663/
23
10/31/2016
Heroin
Ohio Substance Abuse Monitoring (OSAM)
– A law enforcement professional reflected on the link between increased monitoring of prescription opioids and increased use of heroin:“When we [law enforcement] really made the push on the oxy’s [OxyContin®] and on the pain clinics, it really kinda pushed it [drug abusers] over into the heroin … and you’re seeing it almost as a national trend now
(OSAM) Jan to June ‘15 http://mha.ohio.gov/Portals/0/assets/Research/OSAM‐TRI /June2015‐ExecutiveSummary.pdf
• Heroin – easier to get than Rx opioids
– Often mixed with fentanyl
– 1/10th gram $10 ‐ $40
– ½ gram $40 ‐ $90
– 1 gram $80 ‐ $200
• Dealers sell syringes
– $2 ‐ $5 a piece
– Indiana saw 188 new cases of HIV/HCV
• cost ~ $80 million in medical expenses 24
10/31/2016
• Typical user is white 18 – 40 years old
• Some make a living off selling rx opioids – $1‐ $2 /mg
• Hancock Probation: 30% of positive urine screens for Suboxone
– $10 ‐ $35 per film
• For withdrawal
– Kratom, Lyrica 75mg $1.50, Gabapentin 300mg $2 Arrowhead Behavioral
Inpatient: $750 / day x 5days = $3750
1) $250 / day x 10 days over 2 weeks = $2500
Or
2) $175 / day x 18 days over 6 weeks = $3150
Then Suboxone classes at $80 / session. Weekly or monthly.
Not included: med costs, physician fees
25
10/31/2016
References
1)
Rudd, R. Increases in Drug and Opioid Overdose Deaths — United States, 2000–2014. January 1, 2016 / 64(50);1378‐82. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6450a3.htm?s_cid=mm6450a3_w ( Accessed 9/7/2016)
2) Nahin, R. 2015. Estimates of Pain Prevalence and Severity in Adults: United States, 2012. J Pain. 2015 Aug: 16(8):769‐780. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4562413/ (Accessed 9/8/2016)
3) Center for Behavioral Health Statistics and Quality. (2016). Prescription Drug Use and Misues in the United States: Results from the 2015 National Survey on Drug Use and Health (HHS PublicationNo. SMA 16‐4984, NSDUH Series H‐51). Retrieved from http://www.samhsa.gov/data/. Accessed: 9/8/2016
4) Center for Behavioral Health Statistics and Quality. (2016). Key substance use and mental health indicators in the United States: Results from the 2015 National Survey on Drug Use and Health (HHS PublicationNo. SMA 16‐4984, NSDUH Series H‐
51). Retrieved from http://www.samhsa.gov/data/sites/default/files/NSDUH‐FFR2‐2015/NSDUH‐FFR2‐2015.htm /. Accessed: 9/8/2016
5) Institute of Medicine Report from the Committee on Advancing Pain Research, Care, and Education: Relieving Pain in America, A Blueprint for Transforming Prevention, Care, Education and Research. The National Academies Press, 2011.
http://books.nap.edu/openbook.php?record_id=13172&page=1.
6) The economic costs of pain in the United States. J Pain. 2012 Aug;13(8):715‐24. doi: 10.1016/j.jpain.2012.03.009. Epub
2012 May 16. http://www.jpain.org/article/S1526‐5900(12)00559‐7/fulltext
7) http://www.cdc.gov/vitalsigns/pdf/2011‐11‐vitalsigns.pdf
8) Fala L, Welz JA. New perspectives in treatment of opioid‐induced respiratory depression. American Health & Drug Benefits. Oct 2015. Vol 8: 6 Supl 3 S51‐63
9) https://my.clevelandclinic.org/health/healthy_living/hic_Pre‐participation_Evaluations/hic_Vital_Signs
10) Goodman & Gillman 11th ed. P 390
11) White JM, Irvine RJ. Mechanisms of fatal opioid overdose. Addiction. 1999;94:961–72. [PubMed]
12) http://www.medscape.com/viewarticle/749755_3 . Risk Factors for Opioid‐Induced Excessive Respiratory Depression Carla R. Jungquist, RN, PhD; Suzanne Karan, MD; Michael L. Perlis, PhDPain Manag Nurs. 2011;12(3):180‐187.
26
Risk Evaluation and Mitigation Strategies (REMS) for
Extended-Release and Long-Acting Opioids
James E. Preston, D.O., FAODME
Learning Objective:
Describe the opioid crisis in America and the REMS development as a consortia to
improve the physician opioid prescribing safety and appropriateness.
List several representative opioids commercially available and their indications.
Describe the contraindications to opioids and safe opioid prescribing procedures.
List the patient consent and educational requirements for opioid prescriptions.
10/31/2016
Presented by CO*RE
Collaboration for Relevant Presented
Educationby CO*RE
www.core-rems.org Collaboration for REMS Education
www.corerems.org
Collaborative for
REMS Education
Collaborative for REMS Education
James E. Preston, DO, FAODME
Bio:
Senior Medical Director
Stein Hospice and Palliative Care Inc.
Assistant Dean, Clinical Affairs
Ohio University Heritage College of
Osteopathic Medicine
Program Director
Firelands Regional Medical Center
Fellowship
Hospice and Palliative Medicine
DISCLOSURE:
Dr. Preston has nothing to disclose.
2 | © CO*RE 2013
Collaborative for REMS Education
1
10/31/2016
James E. Preston, DO, FAODME
Senior Medical Director
Stein Hospice and Palliative Care Inc.
Assistant Dean, Clinical Affairs
Ohio University Heritage College of
Osteopathic Medicine
Program Director
Firelands Regional Medical Center
Fellowship in Hospice and Palliative Medicine
DISCLOSURE:
Dr. Preston has nothing to disclose.
Collaborative for REMS Education
3 | © CO*RE 2013
Collaborative for REMS Education
On July 9, 2012, the
Food and Drug
Administration (FDA)
approved a Risk
Evaluation and
Mitigation Strategy
(REMS) for extendedrelease (ER) and longacting (LA) opioid
medications.
Founded in June, 2010, the
Collaborative on REMS Education
(CO*RE), a multi-disciplinary team of
13 partners has designed a core
curriculum based on needs assessment,
practice gaps, clinical competencies,
and learner self-assessment to meet
the requirements of the FDA REMS
Blueprint.
www.core-rems.org
4 | © CO*RE 2015
Collaborative for REMS Education
2
10/31/2016
Organizations
Our Partners







American Pain Society (APS)
•
American Academy of Hospice and
Palliative Medicine (AAHPM)
•
American Association of Nurse
Practitioners (AANP)
•
American Academy of Physician
Assistants (AAPA)
American Osteopathic Association
(AOA)
American Society of Addiction
Medicine (ASAM)
•
Healthcare Performance
Consulting (HPC)
Interstate Postgraduate Medical
Association (IPMA)
Nurse Practitioner Healthcare
Foundation (NPHF)
Physicians Institute for Excellence
in Medicine which coordinates 15
state medical societies
•
Medscape
•
American College of Emergency
Physicians (ACEP)
California Academy of Family
Physicians (CAFP)
Collaborative for REMS Education
6 | © CO*RE 2015
Collaborative for REMS Education
3
10/31/2016
Content Development/Planner/Reviewer Disclosures
The following individuals disclose no relevant financial relationships:
David Bazzo, MD
Professor of Family Medicine, University of California San Diego School of Medicine
Roberto Cardarelli, DO, MPH
Professor, Department of Family and Community Medicine, University of Kentucky College of Medicine
Ronald Crossno, MD
Senior National Medical Director, Gentiva Health Services, Rockdale, TX
Katherine Galluzzi, DO
Professor and Chair, Department of Geriatrics, Philadelphia College if Osteopathic Medicine, Philadelphia, PA
Carol Havens, MD
Family physician and addiction medicine specialist, The Permanente Medical Group, Sacramento, CA
Randall Hudspeth PhD, APRN‐CNP, FRE, FAANP
Practice and Regulation Consultant in Advanced Practice Pain Management and Palliative Care
Edwin A. Salsitz, MD, FASM
Beth Israel Medical Center, Division of Chemical Dependency; Assistant Professor, Albert Einstein College of Medicine
Barbara St. Marie, PhD, ANP‐BC
Supervisor, Pain and Palliative Care; Adult and Gerontology Nurse Practitioner, Pain Management, Associate Faculty, University of Iowa College of Nursing, Iowa City, IA
Cynthia Kear, CHCP, MDiv
Jerri Davis, CHCP
Senior Vice President, California Academy of Family Physicians, San Francisco, CA
Director, Continuing Professional Development, California Academy of Family Physicians
Robin and Neil Heyden
Staff, CO*RE Operations Team, Heyden TY, Alameda, CA
Julie Bruno, MSW LCSW
Director, Education and Training, American Academy of Hospice and Palliative Medicine, Chicago, IL
Anne Norman, DNP, APRN, FNP‐BC
Associate Vice President of Education, American Association of Nurse Practitioners
Marie‐ Michele Leger, MPH, PA‐C
Eric D. Peterson, EdM, FACEHP
Director, Clinical Education, American Academy of Physician Assistants, Alexandria, VA
Senior Director, Performance Improvement CME, American Academy of Physician Assistants
Collaborative for REMS Education
CO*RE Staff Disclosures
The following individuals disclose no relevant financial relationships:
Stephanie Townsell, MPH
Sharon McGill, MPH
Public Health Project Manager, Department of Research and Development, American Osteopathic
Association, Chicago, IL
Director, Department of Quality and Research, American Osteopathic Association, Chicago, IL
Jennifer Reinard
Catherine Underwood, MBA, CAE
Education Manager, American Pain Society
Chief Executive Officer, American Pain Society, Chicago, IL
Arlene Deverman, CAE, CFRE
Penny Mills, MBA
Vice President, Professional Development, American Society of Addiction Medicine
Executive Vice President and CEO, American Society of Addiction Medicine Chevy Chase, MD
Thomas McKeithen Jr, BS, MBA
Chris Larrison
Partners, Healthcare Performance Consulting Inc., Indianapolis, IN
Kate Nisbet, BBA, MBA
Mary Ales, BA
Director of Health Systems Education, Interstate Postgraduate Medical Association
Executive Director, Interstate Postgraduate Medical Association, Madison, WI
Pam Jenkins‐Wallace, MS, NP
Phyllis Zimmer, MN, FNP, FAAN
Program Director, NPHF Continuing Education Program
President, Nurse Practitioner Healthcare Foundation, Bellevue, WA
Sara Bennett
Adele Cohen, MS, PCMH CCE
Project Manager, Physicians’ Institute for Excellence in Medicine
Senior Vice President, Physicians’ Institute for Excellence in Medicine, Atlanta, GA
Piyali Chatterjee
Cyndi Grimes, CCMEP
Sarah Williams, PhD
Director, Medical Education, Medscape, LLC New York ,NY
CME/CE Director, Medscape, LLC, New York, NY
Scientific Director, Medscape, LLC, New York, NY
Cynthia Singh
Lori Foley
Director, Grants and Foundation Development, American College of Emergency Physicians
Director, Strategic Partnerships, American College of Emergency Physicians, Irving, TX
8 | © CO*RE 2015
Collaborative for REMS Education
4
10/31/2016
Acknowledgement
Presented by [Insert Partner Name], a member
of the Collaborative on REMS Education
(CO*RE), 13 interdisciplinary organizations working
together to improve pain management
and prevent adverse outcomes.
This educational activity is supported by an
independent educational grant from the ER/LA
Opioid Analgesic REMS Program
Companies. Please see http://ce.er-laopioidrems.com/IwgCEUI/rems/pdf/List_of_RPC_Co
mpanies.pdf for a listing of the member
companies. This activity is intended to be fully
compliant with the ER/LA Opioid Analgesic REMS
education requirements issued by the US Food &
Drug Administration.
9
9 || ©
© CO*RE
CO*RE 2015
2013
Collaborative for REMS Education
Products Covered by this REMS
Brand Name Products
sulfate ER capsules
Belbuca® buprenorphine buccal film
Butrans® buprenorphine transdermal system
Dolophine® methadone hydrochloride tablets
Duragesic® fentanyl transdermal system
Embeda® morphine sulfate/naltrexone ER capsules
Exalgo® hydromorphone hydrochloride ER tablets
Hysingla® ER (hydrocodone bitartrate) ER tablets
Kadian® morphine sulfate ER capsules
MorphaBond® morphine sulfate ER tablets
MS Contin® morphine sulfate CR tablets
Nucynta® ER tapentadol ER tablets
Opana® ER oxymorphone hydrochloride ER tablets
OxyContin® oxycodone hydrochloride CR tablets
Targiniq™ oxycodone hydrochloride/naloxone
hydrochloride ER tablets
• Zohydro® hydrocodone bitartrate ER capsules
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
Avinza® morphine
8 | © CO*RE 2015
Generic Products
• Fentanyl ER transdermal
systems
• Methadone hydrochloride
tablets
• Methadone hydrochloride
oral concentrate
• Methadone hydrochloride
oral solution
• Morphine sulfate
ER tablets
• Morphine sulfate
ER capsules
• Oxycodone hydrochloride
ER tablets
Collaborative for REMS Education
5
10/31/2016
© CO*RE 2014
WHY PRESCRIBER EDUCATION
IS IMPORTANT
Introduction
Collaborative for REMS Education
11 | © CO*RE 2015
Prescribers of ER/LA
Opioids Should Balance:
The benefits
of prescribing
ER/LA opioids
to treat pain
The risks
of serious
adverse
outcomes
ER/LA opioid analgesics should be prescribed only by health care professionals
who are knowledgeable in the use of potent opioids for the management of pain
12 | © CO*RE 2015
Collaborative for REMS Education
6
10/31/2016
Opioid Misuse/Abuse is a Major
Public Health Problem
Improper use of any opioid can result in serious AEs
including overdose & death
This risk can be greater w/ ER/LA opioids
ER opioid dosage units contain more
opioid than IR formulations
Methadone is a potent opioid with
a long, highly variable half-life
In 2012
In 2011
37 million Americans age ≥12
had used an opioid for
nonmedical use some
time in their life
488,004 ED visits involved
nonmedical use of opioids
• Methadone involved in 30% of
prescription opioid deaths
SAMHSA. (2013). Results from the 2012 National Survey on Drug Use and Health: Detailed Tables. NSDUH Series H-46, HHS Publication No. (SMA) 13-4795. Rockville, MD. SAMHSA.
(2013). Drug Abuse Warning Network, 2011: National Estimates of Drug-Related Emergency Department Visits. HHS Publication No. (SMA) 13-4760, DAWN Series D-39. Rockville,
MD. CDC. CDC Vital Signs. Prescription Painkiller Overdoses. Use and abuse of methadone as a painkiller. 2012. FDA. Questions and Answers: FDA approves a Risk Evaluation and
Mitigation Strategy for Extended-Release and Long-Acting Opioid Analgesics. www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm309742.htm. 2012.
13 | © CO*RE 2015
Collaborative for REMS Education
In 2013
43,982 Americans
DIED FROM DRUG POISONINGS
Nearly 16,235 deaths involved prescription opioids
In 2008
NCHS Data Fact Sheet, June 2015 http://www.cdc.gov/nchs/data/factsheets/factsheet_drug_poisoning.pdf
CDC. Policy Impact: Prescription Painkiller Overdoses. http://www.cdc.gov/homeandrecreationalsafety/rxbrief/ (Historical
content - 2008 data) (accessed on 1/6/15).
14 | © CO*RE 2014
Collaborative for REMS Education
7
10/31/2016
First-Time Use of Specific Drugs
Among Persons Age ≥ 12 (2012)
Number in millions
3
2.5
2
1.5
1
2.4
1.9
1.4
0.9
0.7
0.5
0.6
0.6
0.4
0.2
0.2
0
SAMHSA. (2013). Results from the 2012 National Survey on Drug Use and Health: Summary of National Findings.
NSDUH Series H-46, HHS Publication No. (SMA) 13-4795. Rockville, MD.
15 | © CO*RE 2015
0.1
Collaborative for REMS Education
Learning Objectives
Describe the opioid crisis in America, and the REMS development as a
consortia to improve the physician opioid prescribing safety and
appropriateness.
List several representative opioids commercially available and their
indications
Describe the contra-indications to opioids and safe opioid prescribing
procedures.
List the patient consent and education requirements for opioid
prescriptions.
16 | © CO*RE 2015
Collaborative for REMS Education
8
10/31/2016
Misuse, abuse, divergence and
overdose of ER/LA opioids is a major
public health crisis.
YOU and YOUR TEAM can have an
immediate and positive impact on this
crisis while also caring for your
patients appropriately.
Collaborative for REMS Education
17 | © CO*RE 2015
© CO*RE 2014
ASSESSING PATIENTS FOR
TREATMENT WITH ER/LA OPIOID
ANALGESIC THERAPY
Unit 1
18 | © CO*RE 2015
Collaborative for REMS Education
9
10/31/2016
Balance Risks Against Potential Benefits
•
•
Conduct thorough H&P
and appropriate testing
Comprehensive benefitto-harm evaluation
Benefits Include
Risks Include
Analgesia
(adequate pain control)
Improved Function
• Overdose
• Life-threatening respiratory depression
• Abuse by patient or household contacts
• Misuse & addiction
• Physical dependence & tolerance
• Interactions w/ other medications &
substances
• Risk of neonatal withdrawal syndrome
w/ prolonged use during pregnancy
• Inadvertent exposure/ingestion by
household contacts, especially children
Chou R, et al. J Pain. 2009;10:113-30. Department of Veterans Affairs, Department of Defense. VA/DoD Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain. 2010.
FDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics. Modified 08/2014. www.fda.gov/downloads/
Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM311290.pdf
19 | © CO*RE 2015
Collaborative for REMS Education
Adequately DOCUMENT
all patient interactions,
assessments, test results,
& treatment plans
20 | © CO*RE 2015
Collaborative for REMS Education
10
10/31/2016
Clinical Interview: Patient Medical History
Illness relevant to (1) effects or (2) metabolism of opioids
1. Pulmonary disease, constipation, nausea, cognitive impairment
2. Hepatic, renal disease
Illness possibly linked to substance abuse, e.g.:
Hepatitis
HIV
Tuberculosis
Cellulitis
STIs
Trauma,
burns
Cardiac
disease
Pulmonary
disease
Chou R, et al. J Pain. 2009;10:113-30. Zacharoff KL, et al. Managing Chronic Pain with Opioids in Primary Care. 2nd ed.
Newton, MA: Inflexion, Inc., 2010. Department of Veterans Affairs, Department of Defense. VA/DoD Clinical Practice
Guideline for Management of Opioid Therapy for Chronic Pain. 2010.
21 | © CO*RE 2015
Collaborative for REMS Education
Clinical Interview: Pain & Treatment History
Description of pain
Location
Intensity
Quality
Onset/
Duration
Variations /
Patterns / Rhythms
What relieves the pain?
What relieves the pain?
What causes or increases pain?
Effects of pain on physical, emotional, and psychosocial function
Patient’s pain & functional goals
Heapy A, Kerns RD. Psychological and Behavioral Assessment. In: Raj's Practical Management of
Pain. 4th ed. 2008;279-95. Zacharoff KL, et al. Managing Chronic Pain with Opioids in Primary
Care. 2nd ed. Newton, MA: Inflexion, Inc., 2010.
22 | © CO*RE 2015
Collaborative for REMS Education
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10/31/2016
Clinical Interview: Pain & Treatment History, cont’d
Pain Medications
Past use
Current use
• Query state PDMP where available to confirm patient report
• Contact past providers & obtain prior medical records
• Conduct UDT
Dosage
• For opioids currently prescribed: opioid, dose, regimen, & duration
‒ Important to determine if patient is opioid tolerant
General effectiveness
Nonpharmacologic strategies & effectiveness
Collaborative for REMS Education
23 | © CO*RE 2015
Perform Thorough Evaluation
& Assessment of Pain
Seek objective
confirmatory data
General: vital signs,
appearance, posture,
gait, & pain behaviors
Neurologic exam
Components of
patient evaluation
for pain
Musculoskeletal Exam
• Inspection
• Palpation
• Percussion
• Auscultation
• Provocative
maneuvers
Lalani I, Argoff CE. History and Physical Examination of the Pain Patient. In: Raj's Practical Management of Pain.
4th ed. 2008;177-88. Chou R, et al. J Pain. 2009;10:113-30.
24 | © CO*RE 2015
Order diagnostic
tests (appropriate
to complaint)
Cutaneous or
trophic findings
Collaborative for REMS Education
12
10/31/2016
Assess Risk of Abuse, Including Substance
Use & Psychiatric Hx
Obtain a complete Hx of current & past substance use
• Prescription drugs
• Illegal substances
• Alcohol & tobacco
Social history also
relevant
‒ Substance abuse Hx does not prohibit
treatment w/ ER/LA opioids but may
require additional monitoring & expert
consultation/referral
• Family Hx of substance abuse &
psychiatric disorders
• Hx of sexual abuse
Employment, cultural
background, social
network, marital history,
legal history, & other
behavioral patterns
Collaborative for REMS Education
25 | © CO*RE 2015
Risk Assessment, cont’d
Be knowledgeable
about risk factors
for opioid abuse
• Personal or family
Hx of alcohol or
drug abuse
• Younger age
• Presence of
psychiatric
conditions
26 | © CO*RE 2015
Understand &
use addiction
or abuse
screening tools
• Assess potential
risks associated
w/ chronic
opioid therapy
Conduct a UDT
• Understand
limitations
• Manage patients
using ER/LA
opioids based on
risk assessment
Collaborative for REMS Education
13
10/31/2016
Risk Assessment Tools: Examples
Tool
# of items
Administered
By
5
patient
Patients considered for long-term opioid therapy:
ORT Opioid Risk Tool
SOAPP® Screener
& Opioid Assessment for Patients w/ Pain
24, 14, & 5
patient
7
clinician
PMQ Pain Medication Questionnaire
26
patient
COMM Current Opioid Misuse Measure
17
patient
PDUQ Prescription Drug Use Questionnaire
40
clinician
4
clinician
DIRE Diagnosis, Intractability, Risk, & Efficacy Score
Characterize misuse once opioid treatments begins:
Not specific to pain populations:
CAGE-AID Cut Down, Annoyed, Guilty, Eye-Opener Tool,
Adjusted to Include Drugs
RAFFT Relax, Alone, Friends, Family, Trouble
5
patient
DAST Drug Abuse Screening Test
28
patient
Varies
clinician
SBIRT Screening, Brief Intervention, & Referral to Treatment
Collaborative for REMS Education
27 | © CO*RE 2015
Opioid Risk Tool (ORT)
Mark each box that applies
1.
2.
Female
Male
Family Hx of substance abuse
Alcohol
1
3
Illegal drugs
2
3
Prescription drugs
4
4
Personal Hx of substance abuse
Alcohol
3
3
Illegal drugs
4
4
Prescription drugs
5
5
3.
Age between 16 & 45 yrs
1
1
4.
Hx of preadolescent sexual abuse
3
0
5.
Psychologic disease
ADD, OCD, bipolar, schizophrenia
2
2
Depression
1
1
Administer
On initial visit
Prior to opioid
therapy
Scoring (risk)
0-3: low
4-7: moderate
≥8: high
Scoring Totals:
Webster LR, Webster RM. Pain Med. 2005;6:432-42.
28 | © CO*RE 2015
Collaborative for REMS Education
14
10/31/2016
Screener & Opioid Assessment for
Patients with Pain (SOAPP)®
Identifies patients as at high, moderate, or low risk for
misuse of opioids prescribed for chronic pain
How is SOAPP® administered?
Usually selfadministered in
waiting room,
exam room, or
prior to an
office visit
May be completed
as part of an
interview w/ a
nurse, physician,
or psychologist
SOAPP® Monitoring Recommendations. https://painedu.org/soapp/SOAPP_Monitoring_Recommendations.pdf
The SOAPP® Version 1.0 Tutorial. https://painedu.org/soapp-tutorial_01.asp
29 | © CO*RE 2015
Prescribers should
have a completed
& scored SOAPP®
while making
opioid treatment
decisions
Collaborative for REMS Education
When to Consider a Trial of an Opioid
Potential benefits are likely to outweigh risks
Failed to adequately respond to nonopioid & nondrug interventions
Continuous, around-the-clock opioid analgesic is
needed for an extended period of time
Pain is chronic and severe
No alternative therapy is likely to pose as
favorable a balance of benefits to harms
Chou R, et al. J Pain. 2009;10:113-30. Department of Veterans Affairs, Department of Defense.
VA/DoD Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain. 2010.
30 | © CO*RE 2015
Collaborative for REMS Education
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When to Consider a Trial of an Opioid, cont’d
60-yr-old w/ chronic disabling OA pain
• Nonopioid therapies not effective, IR opioids provided some
relief but experienced end-of-dose failure
• No psychiatric/medical comorbidity or personal/family
drug abuse Hx
‒ High potential benefits relative to potential risks
‒ Could prescribe opioids to this patient in most settings w/ routine monitoring
30-yr-old w/ fibromyalgia & recent IV drug abuse
• High potential risks relative to benefits (opioid therapy
not 1st line for fibromyalgia)
• Requires intensive structure, monitoring, & management
by clinician w/ expertise in both addiction & pain
‒ Not a good candidate for opioid therapy
Chou R, et al. J Pain. 2009;10:113-30.
31 | © CO*RE 2015
Collaborative for REMS Education
When to Consider a Trial of an Opioid, cont’d
Selection of patients between these 2 extremes requires:
Careful
assessment &
characterization
of patient risk
Structuring of care
to match risk
In patients w/ Hx of substance abuse
or a psychiatric comorbidity, this may
require assistance from experts in
managing pain, addiction, or other
mental health concerns
In some cases opioids may not be
appropriate or should be deferred
until the comorbidity has been
adequately addressed
‒ Consider referral
Chou R, et al. J Pain. 2009;10:113-30.
32 | © CO*RE 2015
Collaborative for REMS Education
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Referring High-Risk Patients
Prescribers should
Understand when to
appropriately refer
high-risk patients to
pain management or
addiction specialists
Also check your state
regulations for
requirements
Chou R, et al. J Pain. 2009;10:113-30.
33 | © CO*RE 2015
Collaborative for REMS Education
Special Considerations:
Elderly Patients
Does patient have medical problems that increase risk of
opioid-related AEs?
Respiratory depression more likely in elderly, cachectic, or
debilitated patients
• Altered PK due to poor fat stores, muscle wasting, or altered clearance
• Monitor closely, particularly when
− Initiating & titrating ER/LA opioids
− Given concomitantly w/ other drugs that depress respiration
• Reduce starting dose to 1/3 to 1/2 the usual dosage in debilitated, nonopioid-tolerant patients
• Titrate dose cautiously
Older adults more likely to develop constipation
• Routinely initiate a bowel regimen before it develops
Is patient/caregiver likely to manage opioid therapy responsibly?
American Geriatrics Society Panel on the Pharmacological Management of Persistent Pain in Older Persons. J Am Geriatr Soc. 2009;57:133146. Chou R, et al. J Pain. 2009;10:113-30.
34 | © CO*RE 2015
Collaborative for REMS Education
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Special Considerations:
Pregnant Women
Managing chronic pain in pregnant women is challenging,
& affects both mother and fetus
Potential risks of opioid therapy to the newborn include:
• Low birth weight
• Premature birth
• Hypoxic-ischemic brain injury
• Neonatal death
• Prolonged QT syndrome
• Neonatal opioid withdrawal syndrome
Given these potential risks, clinicians should:
• Counsel women of childbearing potential about risks & benefits of
opioid therapy during pregnancy & after delivery
• Encourage minimal/no opioid use during pregnancy, unless potential
benefits outweigh risks
If chronic opioid therapy is used during pregnancy, anticipate &
manage risks to the patient and newborns
Chou R, et al. J Pain. 2009;10:113-30.
35 | © CO*RE 2015
Collaborative for REMS Education
Special Considerations:
Children (<18 years)
Safety & effectiveness of most ER/LA
opioids unestablished
Pediatric analgesic trials pose challenges
Transdermal fentanyl approved in children aged ≥2 yrs
Oxycodone ER dosing changes for children ≥ 11 yrs (see Unit 6)
Most opioid studies focus on inpatient safety
Opioids are common sources of drug error
Opioid indications are primarily life-limiting conditions
Few children with chronic pain due to non-life-limiting
conditions should receive opioids
When prescribing opioids to children:
Consult pediatric palliative care team or pediatric pain
specialist or refer to a specialized multidisciplinary pain clinic
36 | © CO*RE 2013
Berde CB, et al. Pediatrics. 2012;129:354-64. Gregoire MC, et al. Pain Res Manag 2013;18:47-50.
Mc Donnell C. Pain Res Manag. 2011;16:93-8. Slater ME, et al. Pain Med.
2010;11:207-14.
Collaborative
for
REMS Education
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Challenge: The Friday Afternoon Patient
Red Flag:
Adjusting a
prescription
without
performing
appropriate
evaluation or
screening
37 | © CO*RE 2015
It is 4 pm on Friday and you are four patients
behind schedule. Mr. Kingston asks you to
increase his current dosage of hydrocodone,
because he says it is not relieving his pain. It
would take you two minutes to say yes.
Action: Check your local PDMP. Employ
practice management strategies that maximize
efficiency.
• Patient-administered screening tools
• Office staff to administer and score tools,
document results, and communicate to the
prescriber
Collaborative for REMS Education
Challenge: The Delayed Surgery
Red Flag:
Patient may be
stalling to
continue an
opioid regimen
Ms. Van Buskirk says she needs opioids to
manage her pain until she can have
surgery. She reports continued delays in
getting to surgery. You phone the
surgeon and discover that no date has
been set and that she has cancelled
several appointments.
Action: Set expectations for time
limitations. Offer non-medicine and nonopioid options for pain management.
Consider referral to addiction specialist.
38 | © CO*RE 2015
Collaborative for REMS Education
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Unit 1
Pearls for Practice
Document EVERYTHING
Conduct a Comprehensive H&P
General and pain-specific
Assess Risk of Abuse
Compare Risks with Expected Benefits
Determine Whether a Therapeutic Trial is Appropriate
Collaborative for REMS Education
39 | © CO*RE 2015
© CO*RE 2014
INITIATING THERAPY,
MODIFYING DOSING, &
DISCONTINUING USE OF ER/LA
OPIOID ANALGESICS
Unit II
40 | © CO*RE 2015
Collaborative for REMS Education
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Federal & State Regulations
Comply w/ federal & state laws & regulations
that govern the use of opioid therapy for pain
Federal
State
• Code of Federal Regulations, Title
• Database of state statutes,
21 Section 1306: rules governing
the issuance & filling of
prescriptions pursuant to section
309 of the Act (21 USC 829)
–
regulations, & policies for
pain management
– www.medscape.com/resource/pain/opioid-policies
– www.painpolicy.wisc.edu/database-statutes-
regulations-other-policies-pain-management
www.deadiversion.usdoj.gov/21cfr/cfr/2106cfrt.htm
• United States Code (USC) -
Controlled Substances Act, Title
21, Section 829: prescriptions
–
www.deadiversion.usdoj.gov/21cfr/21usc/829.htm
Collaborative for REMS Education
41 | © CO*RE 2015
Initiating Treatment
Prescribers should regard initial treatment
as a therapeutic trial
May last from several weeks
to several months
Decision to proceed w/ long-term treatment should be
intentional & based on careful consideration of outcomes
during the trial
Progress toward meeting
therapeutic goals
Presence of opioidrelated AEs
Changes in underlying
pain condition
Changes in psychiatric or
medical comorbidities
Identification of aberrant drug-related
behavior, addiction, or diversion
Chou R, et al. J Pain. 2009;10:113-30
42 | © CO*RE 2015
Collaborative for REMS Education
21
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ER/LA Opioid-Induced
Respiratory Depression
Chief hazard of
opioid agonists,
including
ER/LA opioids
• If not immediately
recognized & treated,
may lead to
respiratory arrest
& death
Manifested by
reduced urge to
breathe &
decreased
respiration rate
Instruct
patients/family
members to
call 911*
• Managed w/ close
observation,
supportive measures,
& opioid antagonists,
depending on
patient’s clinical
status
• Shallow breathing
• CO2 retention can
• Greatest risk: initiation
exacerbate opioid
sedating effects
of therapy or after
dose increase
Chou R, et al. J Pain. 2009;10:113-30. FDA. Blueprint for Prescriber Education for
Extended-Release and Long-Acting Opioid Analgesics. 08/2014.
www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafety
InformationforPatientsandProviders/UCM311290.pdf
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43 | © CO*RE 2015
ER/LA Opioid-Induced
Respiratory Depression
More likely to occur
• In elderly, cachectic, or debilitated
patients
– Contraindicated in patients w/
respiratory depression or conditions
that increase risk
• If given concomitantly w/ other
drugs that depress respiration
Reduce risk
• Proper dosing & titration are
essential
• Do not overestimate dose when
converting dosage from another
opioid product
– Can result in fatal overdose w/
first dose
• Instruct patients to swallow
tablets/capsules whole
– Dose from cut, crushed, dissolved, or
chewed tablets/capsules may be fatal,
particularly in opioid-naïve individuals
FDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics. 08/2014.
www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM311290.pdf
44 | © CO*RE 2015
Collaborative for REMS Education
22
10/31/2016
Initiating & Titrating:
Opioid-Naïve Patients
Monitor patients
closely
for respiratory
depression
Drug & dose selection
is critical
Some ER/LA opioids or
dosage forms are only
recommended for
opioid-tolerant patients
Especially within 24-72 h
of initiating therapy &
increasing dosage
• ANY strength of transdermal
fentanyl or hydromorphone ER
• Certain strengths/doses of
other ER/LA products (check
drug PI)
Individualize dosage by
titration based on
efficacy, tolerability,
& presence of AEs
Check ER/LA opioid
product PI for minimum
titration intervals
Supplement w/ IR
analgesics (opioids
& nonopioid) if pain
is not controlled
during titration
The ER/LA Opioid Analgesics Risk Evaluation & Mitigation Strategy. Selected Important Safety Information. Abuse potential & risk of life-threatening respiratory depression.
www.er-la-opioidrems.com/IwgUI/rems/pdf/important_safety_information.pdf. 2012. Chou R, et al. J Pain. 2009;10:113-30. FDA. Blueprint for Prescriber Education for
ER/LA Opioid Analgesics. 08/2014. www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafety InformationforPatientsandProviders/UCM311290.pdf
45 | © CO*RE 2015
Collaborative for REMS Education
Initiating: Opioid-Tolerant Patients
If opioid tolerant –
no restrictions on which products can be used
Patients considered opioid tolerant are
taking at least
– 60 mg oral morphine/day
– 25 mcg transdermal fentanyl/hr
– 30 mg oral oxycodone/day
For 1 Wk
Or Longer
– 8 mg oral hydromorphone/day
– 25 mg oral oxymorphone/day
– An equianalgesic dose of another opioid
Still requires caution when rotating a
patient on an IR opioid to a different
ER/LA opioid
The ER/LA Opioid Analgesics Risk Evaluation & Mitigation Strategy. Selected Important Safety Information. Abuse potential & risk of life-threatening respiratory depression.
www.er-la-opioidrems.com/IwgUI/rems/pdf/important_safety_information.pdf. 2012.
46 | © CO*RE 2015
Collaborative for REMS Education
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Opioid Rotation
Definition:
Change from an existing opioid regimen to another
opioid w/ the goal of improving therapeutic outcomes or to
avoid AEs attributed to the existing drug, e.g., myoclonus
Rationale:
Differences in pharmacologic or other effects make it likely that a
switch will improve outcomes
• Effectiveness & AEs of different mu opioids vary among patients
• Patients show incomplete cross-tolerance to new opioid
– Patient tolerant to 1st opioid can have improved analgesia from 2nd
opioid at a dose lower than calculated from an EDT
Fine PG, et al. J Pain Symptom Manage. 2009;38:418-25. Knotkova H, et al. J Pain Symptom Manage. 2009;38:426-39.
Pasternak GW. Neuropharmacol. 2004;47(suppl 1):312-23.
47 | © CO*RE 2015
Collaborative for REMS Education
Equianalgesic Doses
Opioid rotation requires calculation of an
approximate equianalgesic dose
Equianalgesic dose is a
construct derived from relative
opioid potency estimates
• Potency refers to dose required
to produce a given effect
Relative potency estimates
• Ratio of doses necessary
to obtain roughly
equivalent effects
• Calculate across drugs or
routes of administration
• Relative analgesic potency is
converted into an
equianalgesic dose by applying
the dose ratio to a standard
48 | © CO*RE 2015
Collaborative for REMS Education
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10/31/2016
Equianalgesic Dose Tables (EDT)
Many different versions:
Published
Online
Online Interactive
Smart-phone apps
Vary in terms of:
Equianalgesic values
Which opioids
are included:
Whether ranges
are used
May or may not include transdermal opioids, rapid-onset
fentanyl, ER/LA opioids, or opioid agonist-antagonists
Collaborative for REMS Education
49 | © CO*RE 2015
Example of an EDT for Adults
Drug
Morphine
Oxycodone
Hydrocodone
Hydromorphone
50 | © CO*RE 2015
Equianalgesic Dose
SC/IV
PO
Parenteral
Usual Starting Doses
PO
10 mg
30 mg
2.5-5 mg SC/IV q3-4hr
( 1.25 – 2.5mg)
NA
20 mg
NA
NA
1.5 mg
30 mg
7.5 mg
5-10 mg q3-4
( 2.5 mg)
5 mg q3-4h
( 2.5 mg)
NA
0.2-0.6 mg SC/IV q2-3hr
( 0.2mg)
5-15 mg q3-4hr
(IR or oral solution)
( 2.5-7.5 mg)
1-2 mg q3-4hr
(
0.5-1 mg)
Collaborative for REMS Education
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Limitations of EDTs
Single-dose potency studies using a specific route,
conducted in patients w/ limited opioid exposure
Did Not Consider
Chronic dosing
High opioid doses
Other routes
Different pain types
Comorbidities or
organ dysfunction
Gender, ethnicity,
advanced age, or
concomitant
medications
Direction of switch
from 1 opioid to
another
Inter-patient
variability in
pharmacologic
response to opioids
Incomplete crosstolerance among
mu opioids
Collaborative for REMS Education
51 | © CO*RE 2015
Utilizing Equianalgesic Doses
Incomplete cross-tolerance & inter-patient
variability require use of conservative dosing
when converting from one opioid to another
Equianalgesic dose a starting point for opioid rotation
Intended as General Guide
Calculated dose of new drug
based on EDT must be
reduced, then titrate the
new opioid as needed
Closely follow patients
during periods of dose
adjustments
Follow conversion instructions in individual ER/LA opioid PI, when provided
52 | © CO*RE 2015
Collaborative for REMS Education
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Guidelines for Opioid Rotation
Reduce calculated equianalgesic
dose by 25%-50%*
Select % reduction based on clinical judgment
Calculate
equianalgesic
dose of new
opioid from
EDT
Closer to 50% reduction if
patient is
• Receiving a relatively
high dose of current
opioid regimen
• Elderly or
medically frail
Closer to 25% reduction
if patient
• Does not have these
characteristics
• Is switching to
a different
administration route
of same drug
*75%-90% reduction for methadone
53 | © CO*RE 2015
Collaborative for REMS Education
Guidelines for Opioid Rotation, cont’d
If switching to methadone:
• Standard EDTs are less helpful in opioid rotation to
methadone
• In opioid tolerant patients, methadone doses should not
exceed 30-40 mg/day upon rotation.
• Consider inpatient monitoring, including serial EKG monitoring
• In opioid-naïve patients, methadone should not be given
as an initial drug
If switching to transdermal:
• Fentanyl, calculate dose conversion based on
equianalgesic dose ratios included in the PI
• Buprenorphine, follow instructions in the PI
54 | © CO*RE 2014
Collaborative for REMS Education
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Guidelines for Opioid Rotation,
cont’d
Have a strategy to frequently assess analgesia, AEs and
withdrawal symptoms
Titrate new opioid dose to optimize outcomes & safety
Dose for breakthrough pain (BTP) using a short-acting, immediate
release preparation is 5%-15% of total daily opioid dose,
administered at an appropriate interval
If oral transmucosal fentanyl product is used for BTP, begin dosing lowest
dose irrespective of baseline opioid dose
NEVER use ER/LA opioids for BTP
Collaborative for REMS Education
55 | © CO*RE 2015
Breakthrough Pain in Chronic
Pain Patients
Patients on stable
ATC opioids may
experience BTP
Disease progression
or a new or
unrelated pain
Therapies
• Directed at cause
of BTP or
precipitating factors
• Nonspecific
symptomatic therapies
to lessen impact
of BTP
Consider adding
• PRN IR opioid trial based
on analysis of benefit
versus risk
‒ Risk for aberrant drug-related
behaviors
‒ High-risk: only in conjunction w/
frequent monitoring & follow-up
‒ Low-risk: w/ routine follow-up &
monitoring
• Nonopioid drug
therapies
• Nonpharmacologic
treatments
56 | © CO*RE 2015
Collaborative for REMS Education
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Reasons for Discontinuing
ER/LA Opioids
No progress toward
therapeutic goals
Intolerable &
Unmanageable AEs
Nonadherence or
unsafe behavior
Pain level decreases in
stable patients
Aberrant behaviors suggestive
of addiction &/or diversion
• 1 or 2 episodes of increasing dose
without prescriber knowledge
• Use of illicit drugs or
unprescribed opioids
• Sharing medications
• Repeatedly obtaining opioids
from multiple outside sources
• Unapproved opioid use to treat
another symptom (e.g., insomnia)
• Prescription forgery
• Multiple episodes of
prescription loss
57 | © CO*RE 2015
Collaborative for REMS Education
Challenge: The Broken Stereotype
Red Flag:
Making
assumptions
about a
patient’s risk
factors without
objective
evidence
58 | © CO*RE 2015
Ms. Yeun seems like a “good” patient. She
has never abused opioids previously. She
has been in the practice a long time, has
never been a problem, and in fact, is rather
enjoyable. She always brings Christmas
cookies for the staff around the holidays.
Action: Require all patients receiving opioids
to follow a treatment plan and adhere to
defined expectations. Evaluate risk in all
patients. Use patient-provider agreements,
contracts, or other tools.
Collaborative for REMS Education
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Challenge: The Early Refill
Red Flag:
Patient requests
an early refill
every month.
You have prescribed Mr. Arias a long-acting
opioid for low back pain and a short-acting
PRN opioid for breakthrough pain. Every
month he requests a refill for both
prescriptions 3-8 days early. Upon
questioning, Mr. Arias tells you that he
takes both pills whenever he feels he needs
them.
Action: Make sure that patients understand each medication’s
dosage, time of day, and maximum daily dose. Ask them to repeat
these instructions back to you. Avoid clinical terms such as “PRN”
that the patient may not understand.
Collaborative for REMS Education
59 | © CO*RE 2015
Unit 2
Pearls for Practice
Treat Initiation of Opioids as a Therapeutic Trial
Anticipate ER/LA Opioid-Induced Respiratory Depression
It can be immediately life-threatening
Be Conservative and Thoughtful In Dosing
When initiating, titrating, and rotating opioids
First calculate equinalgesic dose, then reduce dose appropriately
Discontinue ER/LA opioids slowly and safely
60 | © CO*RE 2015
Collaborative for REMS Education
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© CO*RE 2014
MANAGING THERAPY
WITH ER/LA OPIOID
ANALGESICS
Unit III
61 | © CO*RE 2015
Collaborative for REMS Education
Informed Consent
Before initiating a trial of opioid analgesic therapy, confirm
patient understanding of informed consent to establish:
Analgesic & functional
goals of treatment
The potential for & how to manage:
• Common opioid-related AEs
Expectations
(e.g., constipation, nausea, sedation)
• Other serious risks (e.g., abuse, addiction,
Potential risks
Alternatives to opioids
62 | © CO*RE 2015
respiratory depression, overdose)
• AEs after long-term or high-dose opioid
therapy (e.g., hyperalgesia, endocrinologic or
sexual dysfunction)
Collaborative for REMS Education
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Patient-Prescriber Agreement (PPA)
Document signed by both patient & prescriber
at time an opioid is prescribed
Clarify treatment plan & goals of treatment w/ patient,
patient’s family, & other clinicians involved in patient’s care
Assist in patient education
Inform patients about the risks & benefits
Document patient & prescriber responsibilities
63 | © CO*RE 2015
Collaborative for REMS Education
Consider a PPA
Reinforce expectations for appropriate & safe opioid use
• Obtain opioids from a
• Commitments to return for
• Fill opioid prescriptions at a
• Comply w/ appropriate
single prescriber
designated pharmacy
• Safeguard opioids
– Do not store in medicine
cabinet
– Keep locked (e.g., use a
medication safe)
– Do not share or sell
medication
follow-up visits
monitoring
– E.g., random UDT & pill counts
• Frequency of prescriptions
• Enumerate behaviors that
may lead to opioid
discontinuation
• An exit strategy
• Instructions for disposal when
no longer needed
64 | © CO*RE 2015
Collaborative for REMS Education
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Monitor Patients During
Opioid Therapy
Therapeutic risks &
benefits do not
remain static
Affected by change in
underlying pain
condition, coexisting
disease, or
psychologic/ social
circumstances
Identify patients
• Who are benefiting from
opioid therapy
• Who might benefit more
w/ restructuring of
treatment or receiving
additional services (e.g.,
addiction treatment)
• Whose benefits from
treatment are outweighed
by risks
Periodically assess
continued need for
opioid analgesic
Re-evaluate underlying
medical condition
if clinical presentation
changes
Collaborative for REMS Education
65 | © CO*RE 2015
Monitor Patients During
Opioid Therapy, cont’d
Periodically evaluate:
• Pain control
– Document pain intensity, pattern,
& effects
Patients requiring more
frequent monitoring include:
• High-risk patients
• Patients taking high opioid doses
• Functional outcomes
– Document level of functioning
– Assess progress toward
achieving therapeutic goals
• Health-related QOL
• AE frequency & intensity
• Adherence to prescribed therapies
66 | © CO*RE 2015
Collaborative for REMS Education
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Anticipate & Treat Common AEs
Constipation
Nausea &
vomiting
most common AE; does not
resolve with time
tend to diminish over
days or weeks
 Initiate a bowel regimen before
constipation develops
 Increase fluid & fiber intake, stool
softeners, & laxatives
Oral & rectal antiemetic therapies as needed
 Opioid antagonists may help prevent/treat
opioid-induced bowel dysfunction
Drowsiness &
tend to wane over time
sedation
Counsel patients about driving, work & home
safety as well as risks of concomitant exposure
to other drugs & substances w/ sedating effects
Pruritus &
myoclonus
tend to diminish over
days or weeks
Treatment strategies for either condition
largely anecdotal
Chou R, et al. J Pain. 2009;10:113-30
67 | © CO*RE 2015
Collaborative for REMS Education
Monitor Adherence and
Aberrant Behavior
Routinely monitor patient adherence to treatment plan
• Recognize & document aberrant drug-related behavior
– In addition to patient self-report also use:
• State PDMPs, where available
• UDT
– Positive for nonprescribed drugs
– Positive for illicit substance
– Negative for prescribed opioid
• Family member or caregiver interviews
• Monitoring tools such as the COMM, PADT, PMQ, or PDUQ
• Medication reconciliation (e.g., pill counts)
PADT=Pain Assessment & Documentation Tool
68 | © CO*RE 2015
Collaborative for REMS Education
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Address Aberrant Drug-Related Behavior
Behavior outside the boundaries of
agreed-on treatment plan:
Behaviors that are less
indicative of aberrancy
Behaviors that are more
indicative of aberrancy
Unsanctioned dose escalations or
other noncompliance w/ therapy
on 1 or 2 occasions
Multiple dose escalations or other
noncompliance w/ therapy despite
warnings
Unapproved use of the drug to
treat another symptom
Prescription forgery
Openly acquiring similar drugs
from other medical sources
Obtaining prescription drugs from
nonmedical sources
Collaborative for REMS Education
69 | © CO*RE 2015
Prescription Drug Monitoring
Programs (PDMPs)
49 states have an operational PDMP
DC has enacted PDMP legislation, not yet operational
1 state has no legislation
Individual state laws determine
• Who has access to PDMP information
• Which drug schedules are monitored
• Which agency administers the PDMP
• Whether prescribers are required to register
w/ the PDMP
• Whether prescribers are required to access
PDMP information in certain circumstances
• Whether unsolicited PDMP reports
are sent to prescribers
70 | © CO*RE 2015
Collaborative for REMS Education
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PDMP Benefits
Record of a patient’s
controlled substance
prescriptions
Provide warnings of
potential misuse/abuse
• Some are available
• Existing prescriptions not
• Opportunity to discuss
• Multiple
online 24/7
w/ patient
reported by patient
prescribers/pharmacies
• Drugs that increase overdose
risk when taken together
• Patient pays for drugs of
abuse w/ cash
Prescribers can check their own prescribing Hx
Collaborative for REMS Education
71 | © CO*RE 2015
PDMP Unsolicited Patient
Threshold Reports
Reports automatically generated on patients who cross certain
thresholds when filling prescriptions. Available in some states.
E-mailed to prescribers to
whom prescriptions were
attributed
If inaccurate, contact
PDMP
72 | © CO*RE 2015
Prescribers review records to confirm it is
your patient & you wrote the prescription(s)
attributed to you
If you wrote the prescription(s), patient
safety may dictate need to discuss the
patient w/ other prescribers listed on report
• Decide who will continue to prescribe for the patient &
who might address drug abuse concerns.
Collaborative for REMS Education
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Rationale for Urine Drug Testing (UDT)
Help to identify drug misuse/addiction
• Prior to starting opioid treatment
Assist in assessing adherence during opioid therapy
• As requirement of therapy w/ an opioid
• Support decision to refer
UDT frequency is based on clinical judgment
Depending on patient’s
display of aberrant behavior
and whether it is sufficient to
document adherence to
treatment plan
Check state regulations for
requirements
Collaborative for REMS Education
73 | © CO*RE 2015
Main Types of UDT Methods
Initial testing w/ IA drug panels:
• Classify substance as present or absent according to cutoff
• Many do not identify individual drugs within a class
• Subject to cross-reactivity
• Either lab based or at POC
Identify specific drugs &/or metabolites w/
sophisticated lab-based testing; e.g.,
GC/MS or LC/MS*
• Specifically confirm the presence of a given drug
– e.g., morphine is the opiate causing a positive IA*
• Identify drugs not included in IA tests
• When results are contested
74 | © CO*RE 2015
* GC/MS=gas chromatography/ mass spectrometry
IA=immunoassay
LC/MS=liquid chromatography/ mass spectrometry
Collaborative for REMS Education
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Detecting Opioids by UDT
Most common opiate IA
drug panels
GC/MS or LC/MS will
identify specific opioids
• Detect “opiates” morphine &
• Confirm presence of
• Do not reliably detect
• Identify opioids not included in
codeine, but doesn’t distinguish
semisynthetic opioids
a drug causing a positive IA
IA drug panels, including
semisynthetic & synthetic
opioids
– Specific IA panels can be ordered
for some
• Do not detect synthetic opioids
• Identify opioids not included in
(e.g., methadone, fentanyl)
– Only a specifically directed IA
panel will detect synthetics
IA drug panels, including
semisynthetic & synthetic
opioids
Collaborative for REMS Education
75 | © CO*RE 2015
Interpretation of UDT Results
Positive
Result
Demonstrates recent use
• Most drugs in urine have detection times of 1-3 d
• Chronic use of lipid-soluble drugs: test positive for ≥1 wk
Does not diagnose
• Drug addiction, physical dependence, or impairment
Does not provide enough information to determine
• Exposure time, dose, or frequency of use
Negative
Result
Does not diagnose diversion
• More complex than presence or absence of a drug in urine
May be due to maladaptive drug-taking behavior
• Bingeing, running out early
• Other factors: eg, cessation of insurance, financial difficulties
76 | © CO*RE 2015
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Interpretation of UDT Results, cont’d
Be aware
Testing technologies &
methodologies evolve
Differences exist between IA
test menu panels vary
• Cross-reactivity patterns
– Maintain list of all patient’s prescribed
& OTC drugs
– Assist to identify false-positive result
• Cutoff levels
Time taken to
eliminate drugs
• Document time of last use &
quantity of drug(s) taken
Opioid metabolism may
explain presence
of apparently
unprescribed drugs
Collaborative for REMS Education
77 | © CO*RE 2015
Examples of Metabolism of Opioids
Codeine
Morphine
6-MAM*
Heroin
t½=25-30 min
t½=3-5 min
Hydrocodone
Hydromorphone
Oxycodone
Oxymorphone
*6-MAM=6-monoacetylmorphine
78 | © CO*RE 2015
Collaborative for REMS Education
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Interpretation of UDT Results
Use UDT results in conjunction w/ other clinical information
Investigate unexpected results
Discuss w/ the lab
Schedule appointment
w/ patient to discuss
unexpected/abnormal results
Chart results, interpretation, & action
Do not ignore the unexpected positive result
May necessitate closer monitoring
&/or referral to a specialist
Gourlay DL, et al. Urine Drug Testing in Clinical Practice. The Art & Science of Patient Care. Ed 4. 2010.
79 | © CO*RE 2015
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ER/LA Opioid Use in
Pregnant Women
No adequate & well-controlled studies
Only use if potential benefit justifies the risk to the fetus
Be aware of the pregnancy status of your patients
•
80 | © CO*RE 2015
If prolonged use is required during pregnancy:
Advise patient of risk of neonatal withdrawal syndrome
• Ensure appropriate treatment will be available
Collaborative for REMS Education
40
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Be Ready to Refer
Be familiar w/ referral sources for
abuse or addiction that may arise from
use of ER/LA opioids
SAMHSA substance
abuse treatment
facility locator
SAMHSA mental
health treatment
facility locator
http://findtreatment.samhsa.gov/Treatme
ntLocator/faces/quickSearch.jspx
http://findtreatment.samhsa.gov/MHTreat
mentLocator/faces/quickSearch.jspx
81 | © CO*RE 2015
Collaborative for REMS Education
Challenge: The Insistent Patient
Red Flag:
Patient refuses
to consider
non-opioid
treatment
options
Mr. Lee’s daily function has improved
significantly over the past two years. You suggest
titrating his dosage down or trying alternative
pain management options. He is extremely
resistant and tells you “Nothing else relieves my
pain.”
Action: Work with your patient to set treatment goals and
expectations. Select and document a therapy plan or use a patientprovider agreement. Evaluate Mr. Lee for potential addiction;
consider referral to psychiatry or addiction medicine.
82 | © CO*RE 2015
Collaborative for REMS Education
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Unit 3
Pearls for Practice
Anticipate and Treat Common Adverse Effects
Use Informed Consent and Patient Provider Agreements
Use UDT and PDMP as Valuable Sources of Data About your
Patient
However, know their limitations
Monitor Patient Adherence, Side Effects, Aberrant Behaviors,
and Clinical Outcomes
Refer Appropriately if Necessary
Collaborative for REMS Education
83 | © CO*RE 2015
© CO*RE 2014
COUNSELING PATIENTS &
CAREGIVERS ABOUT THE
SAFE USE OF ER/LA OPIOID
ANALGESICS
Unit IV
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Use Patient
Counseling
Document to
help counsel
patients
Download:
www.er-laopioidrems.com/IwgUI/rems/pdf/patient_co
unseling_document.pdf
Order hard copies:
www.minneapolis.cenveo.com/pcd/SubmitOr
ders.aspx
FDA. EXTENDED-RELEASE (ER) AND LONG-ACTING (LA) OPIOID ANALGESICS RISK EVALUATION AND MITIGATION STRATEGY (REMS). Modified 08/2014. www.fda.gov/downloads/
Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM311290.pdf
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Counsel Patients
About Proper Use
Explain
• Product-specific information about
the prescribed ER/LA opioid
• How to take the ER/LA opioid as
prescribed
• Importance of adherence to
dosing regimen, handling
missed doses, & contacting
their prescriber if pain cannot
be controlled
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Instruct patients/
caregivers to
• Read the ER/LA opioid
Medication Guide
received from pharmacy
every time an ER/LA
opioid is dispensed
• At every medical
appointment explain all
medications they take
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Counsel Patients About Proper Use,
cont’d
Counsel patients/caregivers:
• On the most common AEs of ER/LA opioids
• About the risk of falls, working w/ heavy
machinery, & driving
• Call the prescriber for advice about managing AEs
• Inform the prescriber about AEs
Prescribers should report serious AEs to the FDA:
www.fda.gov/downloads/AboutFDA/ReportsManualsForms
/Forms/UCM163919.pdf
or 1-800-FDA-1088
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Warn Patients
Never break, chew, crush or snort an oral ER/LA
tablet/capsule, or cut or tear patches prior to use
• May lead to rapid release of ER/LA opioid causing
overdose & death
• When a patient cannot swallow a capsule whole, prescribers
should refer to PI to determine if appropriate to sprinkle
contents on applesauce or administer via feeding tube
Use of CNS depressants or alcohol w/ ER/LA
opioids can cause overdose & death
• Use with alcohol may result in rapid release & absorption
of a potentially fatal opioid dose
• Other depressants include sedative-hypnotics & anxiolytics,
illegal drugs
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Warn Patients, cont’d
Misuse of ER/LA opioids can
lead to death
• Take exactly as directed*
• Counsel patients/caregivers on risk
factors, signs, & symptoms of overdose &
opioid-induced respiratory depression, GI
obstruction, & allergic reactions
• Call 911 or poison control
TAKE 1 TABLET BY MOUTH
EVERY 12 HOURS
OXYCONTIN 10 MG
Qty: 60 TABLETS
1-800-222-1222
*Serious side effects, including death, can occur even
when used as recommended
Do not abruptly stop or reduce
the ER/LA opioid use
• Discuss how to safely taper the dose
when discontinuing
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Co-Prescribing Naloxone
Naloxone:
• An opioid antagonist
• Reverses acute opioid-induced respiratory depression
but will also cause withdrawal and reverse analgesia
• Administered intramuscularly and subcutaneously
• Intranasal formulation currently under consideration
with the FDA
Available as:
• Naloxone kit
(w/ syringes,
needles)
• EVZIO™ (naloxone
HCl) auto-injector
• NARCAN nasal
spray
What to do:
• Encourage patients to create an
‘overdose plan’
• Involve and train family, friends, partners
and/or caregivers
• Check expiration dates and keep a viable
dose on hand
• In the event of known or suspected
overdose, administer Naloxone and call
911.
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When to Consider Co-Prescribing Naloxone:
Those at a higher risk for opioid overdose
including…
• Taking opioid high-doses for pain (50 mg/day equiv)
• Receiving rotating opioid medication regimes (at risk for
incomplete cross tolerance)
• On opioid preparations with increased overdose risk
• With respiratory disease (COPD, emphysema, asthma)
• With renal or hepatic impairment
• Concurrent benzodiazepine use
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Abuse Deterrent/Tamper Resistant Opioids
• Response to growing nonmedical use problem
• An ER/LA opioid with physical barrier to deter extraction
• less likely to be crushed, injected, or snorted
• Consider these formulations as one part of an overall REMS
strategy
• There is mixed evidence on the impact of ADF/TR on misuse
• Remember overdose is still possible if taken orally in excessive
amounts
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Protecting the Community
Caution Patients
• Sharing ER/LA opioids w/ others
may cause them to have serious AEs
– Including death
• Selling or giving away ER/LA opioids
is against the law
• Store medication safely and securely
• Protect ER/LA opioids from theft
• Dispose of any ER/LA opioids when
no longer needed
– Read product-specific disposal
information included w/ ER/LA opioid
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Source of Most Recent Rx Opioids
Among Past-Year Users (2011-2012)
0.2%
1.8%
4.3%
5.1%
14.9%
54.0%
19.7%
Free: friend/relative
1 doctor
Bought/took: friend/relative
Other
Drug dealer/stranger
>1 doctor
Bought on Internet
SAMHSA. (2013). Results from the 2012 National Survey on Drug Use and Health: Summary of National Findings.
NSDUH Series H-46, HHS Publication No. (SMA) 13-4795. Rockville, MD.
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Educate Parents: Not in My House
Step 1: Monitor
 Note how many pills in each prescription bottle or
pill packet
 Keep track of refills for all household members
 If your teen has been prescribed a drug, coordinate &
monitor dosages & refills
 Make sure friends & relatives—especially grandparents—
are aware of the risks
 If your teen visits other households, talk to the families
about safeguarding their medications
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Rx Opioid Disposal
New “Disposal Act” expands ways for
patients to dispose of unwanted/expired opioids
Decreases amount of opioids introduced into the environment, particularly into water
Collection receptacles
Call DEA Registration Call Center at
1-800-882-9539 to find a local collection
receptacle
Mail-back packages
Obtained from authorized collectors
Local take-back events
• Conducted by Federal, State, tribal, or
local law enforcement
• Partnering w/ community groups
Voluntarily maintained by:
• Law enforcement
• Authorized collectors, including:
 Manufacturer
 Distributer
 Reverse distributer
 Retail or hospital/clinic pharmacy
• Including long-term care
facilities
DEA National
Prescription Drug
Take-Back Day on
April 30, 2016
DEA. Federal Register. 2014; 79(174):53520-70. Final Rule. Disposal of Controlled Substances. [Docket No. DEA-316] www.deadiversion.usdoj.gov/fed_regs/rules/2014/2014-20926.pdf
DEA. Disposal Act: General Public Fact Sheet. www.deadiversion.usdoj.gov/drug_disposal/fact_sheets/disposal_public.pdf
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Other Methods of
Opioid Disposal
If collection receptacle, mail-back
program, or take-back event unavailable,
throw out in household trash
• Take drugs out of original containers
• Mix w/ undesirable substance, e.g., used
coffee grounds or kitty litter
– Less appealing to children/pets, & unrecognizable
to people who intentionally go through your trash
• Place in sealable bag, can, or other container
– Prevent leaking or breaking out of garbage bag
• Before throwing out a medicine container
– Scratch out identifying info on label
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Prescription Drug Disposal
FDA lists especially harmful medicines –
in some cases fatal w/ just 1 dose –
if taken by someone other than the patient
• Instruct patients to check medication guide
Flush down sink/toilet if no collection
receptacle, mail-back program, or take-back
event available
• As soon as they are no longer needed
– So cannot be accidentally taken by children, pets, or others
• Includes transdermal adhesive skin patches
– Used patch worn for 3d still contains enough opioid to harm/kill a child
– Dispose of used patches immediately after removing from skin
• Fold patch in half so sticky sides meet, then flush down toilet
• Do NOT place used or unneeded patches in household trash
–
Exception is Butrans: can seal in Patch-Disposal Unit provided & dispose of in the trash
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Challenge: The Offended Patient
Red Flag:
You decide not to
request routine
risk assessment
for fear of creating
conflict
Mrs. Jorgensen has been your patient for
eight years and has never caused any
problems. When you ask her to under
urine drug testing, she becomes upset and
accuses you of not trusting her.
Action: Describe UDT as a routine part of medication monitoring
rather than a “drug test”. Create an office policy for performing UDT
on all ER/LA opioid patients. Practice by following universal
precautions. Use a patient-provider agreement to clarify
expectations of treatment.
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Challenge: The Daughter’s Party
Red Flag:
Patients do not
safeguard their
opioid
medications
correctly
Your patient’s daughter, Jody, stole
her father’s opioids from his bedside
drawer to take to a “fishbowl party”.
Her best friend consumed a mix of
opioids and alcohol and died of an
overdose.
Action: Always counsel patients about safe drug storage; warn
patients about the serious consequences of theft, misuse, and
overdose. Tell your patients that taking another person’s
medication, even once, is against the law.
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Unit 4
Pearls for Practice
Establish Informed Consent
Counsel Patients about Proper Use
Appropriate use of medication
Consequences of inappropriate use
Educate the Whole Team
Patients, families, caregivers
Tools and Documents Can Help with Counseling
Use them!
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GENERAL DRUG INFORMATION
FOR ER/LA OPIOID ANALGESIC
PRODUCTS
Unit V
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General ER/LA Opioid Drug Information
Prescribers should be knowledgeable about
general characteristics, toxicities, & drug
interactions for ER/LA opioid products:
ER/LA opioid
analgesic products
are scheduled
under the
Controlled
Substances Act &
can be misused &
abused
Respiratory
depression
is the most
serious
opioid AE
Constipation
is the most
common
long-term
AE
Can be immediately
life-threatening
Should be
anticipated
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For Safer Use: Know Drug
Interactions, PK, & PD
CNS depressants can potentiate
sedation & respiratory depression
Some ER/LA products rapidly
release opioid (dose dump) when
exposed to alcohol
Use w/ MAOIs may increase
respiratory depression
Can reduce efficacy of diuretics
Certain opioids w/ MAOIs can cause
serotonin syndrome
Methadone & buprenorphine can
prolong QTc interval
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Some drug levels may increase
without dose dumping
Inducing release of antidiuretic hormone
Drugs that inhibit or induce CYP
enzymes can increase
or lower blood levels of
some opioids
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Opioid Tolerant
Tolerance to sedating & respiratory-depressant effects is
critical to safe use of certain ER/LA opioid products,
dosage unit strengths, or doses
Patients must be opioid tolerant before using
• Any strength of transdermal fentanyl or hydromorphone ER
• Certain strengths or daily doses of other ER products
Opioid-tolerant patients are
those taking at least
• 60 mg oral morphine/day
• 25 mcg transdermal fentanyl/hr
• 30 mg oral oxycodone/day
• 8 mg oral hydromorphone/day
• 25 mg oral oxymorphone/day
FOR 1 WK
OR LONGER
• An equianalgesic dose of another opioid
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Key Instructions: ER/LA Opioids
Individually titrate to
a dose that provides
adequate analgesia
& minimizes
adverse reactions
Times required
to reach
steady-state plasma
concentrations
are product-specific
Refer to product
information for
titration interval
Continually
re-evaluate to assess
maintenance of
pain control &
emergence of AEs
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Key Instructions: ER/LA Opioids,
cont’d
During chronic
therapy,
especially for
non-cancerrelated pain,
periodically
reassess the
continued need
for opioids
If pain increases,
attempt to
identify
source, while
adjusting dose
When an ER/LA
opioid is no
longer required,
gradually titrate
dose downward
to prevent signs
& symptoms of
withdrawal in
physically
dependent
patients
Do not abruptly discontinue
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Common Drug Information for
This Class
Limitations
of usage
• Reserve for when
alternative options (eg,
non-opioids or IR opioids)
are ineffective, not
tolerated, or otherwise
inadequate
• Not for use as an
as-needed analgesic
• Not for mild pain or pain
not expected to persist for
an extended duration
• Not for acute pain
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Dosage reduction
for hepatic or
renal impairment
See individual drug PI
Relative potency
to oral morphine
• Intended as general guide
• Follow conversion
instructions in individual PI
• Incomplete cross-
tolerance & inter-patient
variability require
conservative dosing when
converting from 1
opioid to another
– Halve calculated
comparable dose & titrate
new opioid as needed
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Transdermal Dosage Forms
Do not cut, damage, chew, or swallow
Exertion or exposure
to external heat can
lead to fatal overdose
Prepare skin: clip not shave - hair &
wash area w/ water
Rotate location of
application
Monitor patients w/ fever for
signs or symptoms of
increased opioid exposure
Metal foil backings are not
safe for use in MRIs
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Drug Interactions Common
to this Class
Concurrent use w/ other CNS
depressants can increase risk
of respiratory depression,
hypotension, profound
sedation, or coma
Reduce initial dose of one
or both agents
May enhance neuromuscular
blocking action of skeletal
muscle relaxants & increase
respiratory depression
Avoid concurrent use of
partial agonists* or mixed
agonist/antagonists† with
full opioid agonist
May reduce analgesic effect &/or
precipitate withdrawal
Concurrent use w/
anticholinergic medication
increases risk of
urinary retention &
severe constipation
May lead to paralytic ileus
*Buprenorphine; †Pentazocine, nalbuphine, butorphanol
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Drug Information Common to
This Class
Use in opioidtolerant patients
• See individual PI for products
which:
– Have strengths or total daily doses
only for use in opioid-tolerant
patients
– Are only for use in opioid-tolerant
patients at all strengths
Contraindications
• Significant respiratory depression
• Acute or severe asthma in an
unmonitored setting or in
absence of resuscitative
equipment
• Known or suspected
paralytic ileus
• Hypersensitivity (e.g., anaphylaxis)
• See individual PI for additional
contraindications
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Unit 5
Pearls for Practice
Patients MUST be opioid-tolerant in order to safely take most
ER/LA opioid products
Be familiar with drug-drug interactions, pharmacokinetics and
pharmacodynamics of ER/LA opioids
Central nervous system depressants (alcohol, sedatives,
hypnotics, tranquilizers, tricyclic antidepressants) can have a
potentiating effect on the sedation and respiratory depression
caused by opioids.
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Challenge: The Patient in the ER
Red Flag:
You are woken
by a telephone
call at 2 am
reporting that
your patient, Mr.
Diallo, is in the
ER with
apparent
respiratory
depression.
Action: Be familiar with risk factors
for respiratory depression and know
when opioids are contra-indicated.
Anticipate possible risks and develop
contingency plans. Teach patients,
family, and caregivers about
respiratory depression and its
symptoms.
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© CO*RE 2014
SPECIFIC DRUG INFORMATION
FOR ER/LA OPIOID ANALGESIC
PRODUCTS
Unit VI
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Specific Characteristics
Know for opioid products you prescribe:
Drug
substance
Formulation
Strength
Dosing
interval
Key
instructions
Use in opioidtolerant
patients
Productspecific safety
concerns
Relative
potency to
morphine
Specific information about
product conversions, if available
Specific drug interactions
For detailed information, refer to online PI:
DailyMed at www.dailymed.nlm.nih.gov Drugs@FDA at www.fda.gov/drugsatfda
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Morphine Sulfate ER Capsules (Avinza)
Capsules 30 mg, 45 mg, 60 mg, 75 mg, 90 mg, and 120 mg
Dosing interval
• Once a day
• Initial dose in opioid non-tolerant patients is 30 mg
Key
instructions
• Titrate in increments of not greater than 30 mg using a minimum of
3-4 d intervals
• Swallow capsule whole (do not chew, crush, or dissolve)
• May open capsule & sprinkle pellets on applesauce for patients who
can reliably swallow without chewing; use immediately
• MDD:* 1600 mg (renal toxicity of excipient, fumaric acid)
Drug
interactions
• Alcoholic beverages or medications w/ alcohol may result in rapid
release & absorption of potentially fatal dose
• P-gp* inhibitors (e.g., quinidine) may increase absorption/exposure of
morphine by ~2-fold
Opioid-tolerant
• 90 mg & 120 mg capsules for use in opioid-tolerant patients only
Productspecific safety
concerns
• None
* MDD=maximum daily dose; P-gp= P-glycoprotein
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Buprenorphine Buccal Film (Belbuca)
75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg, and 900 mcg
Dosing
interval
• Every 12 h (or once every 24 h for initiation in opioid naïve patients
& patients taking less than 30 mg oral morphine sulfate eq
• Opioid-naïve pts or pts taking <30 mg oral morphine sulfate eq:
Initiate treatment with a 75 mcg buccal film, once daily, or if
tolerated, every 12 h
- Titrate to 150 mcg every 12 h no earlier than 4 d after initiation
- Individual titration to a dose that provides adequate analgesia and
minimizes adverse reaction should proceed in increments of 150 mcg every
12 h, no more frequently than every 4 d
Key
instructions
• When converting from another opioid, first taper the current opioid
to no more than 30 mg oral morphine sulfate eq/day prior to
initiating Belbuca
- If prior daily dose before taper was 30 mg to 89 mg oral morphine sulfate
eq, initiate with 150 mcg dose every 12 h
- If prior daily dose before taper was 90 mg to 160 mg oral morphine sulfate
eq, initiate with 300 mcg dose every 12 h
- Titration of the dose should proceed in increments of 150 mcg every 12 h,
no more frequently than every 4 d
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Buprenorphine Buccal Film (Belbuca) cont’d
• Maximum dose: 900 mcg every 12 h due to the potential for QTc
prolongation
Key
instructions
• Severe Hepatic Impairment: Reduce the starting and incremental dose by
half that of patients with normal liver function
• Oral Mucositis: Reduce the starting and incremental dose by half that of
patients without mucositis
• Do not use if the package seal is broken or the film is cut, damaged, or
changed in any way
• CYP3A4 inhibitors may increase buprenorphine levels
Specific Drug
Interactions
Use in OpioidTolerant
Patients
ProductSpecific Safety
Concerns
Relative
Potency: Oral
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Morphine
• CYP3A4 inducers may decrease buprenorphine levels
• Benzodiazepines may increase respiratory depression
• Class IA and III antiarrhythmics, other potentially arrhythmogenic agents,
may increase risk for QTc prolongation and torsade de pointes
• Belbuca 600 mcg, 750 mcg, and 900 mcg are for use following titration
from lower doses of Belbuca
• QTc prolongation and torsade de pointes
• Hepatotoxicity
• Equipotency to oral morphine has not been established.
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Buprenorphine Transdermal System (Butrans)
Transdermal System 5 mcg/hr, 7.5 mcg/hr, 10 mcg/hr, 15 mcg/hr, 20 mcg/hr
Dosing
interval
• One transdermal system every 7 d
• Initial dose in opioid non-tolerant patients on <30 mg morphine
equivalents & in mild-moderate hepatic impairment: 5 mcg/h
• When converting from 30 mg-80 mg morphine equivalents, first taper
to 30 mg morphine equivalent, then initiate w/ 10 mcg/h
• Titrate in 5 or 10 mcg/h increments by using no more than 2 patches
of the 5 or 10 mcg/h system(s) w/ minimum of 72 h prior between
dose adjustments. Total dose from all patches should be ≤20 mcg/h
Key
instructions
• Maximum dose: 20 mcg/h due to risk of QTc prolongation
• Application
•
•
•
•
•
Apply only to sites indicated in PI
Apply to intact/non-irritated skin
Prep skin by clipping hair; wash site w/ water only
Rotate application site (min 3 wks before reapply to same site)
Do not cut
• Avoid exposure to heat
• Dispose of patches: fold adhesive side together & flush down toilet
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Buprenorphine Transdermal System (Butrans)
cont’d
• CYP3A4 inhibitors may increase buprenorphine levels
• CYP3A4 inducers may decrease buprenorphine levels
Drug
interactions
• Benzodiazepines may increase respiratory depression
Opioidtolerant
• 7.5 mcg/h, 10 mcg/h, 15 mcg/h, & 20 mcg/h for use in opioidtolerant patients only
Productspecific
safety
concerns
• QTc prolongation & torsade de pointe
Relative
potency: oral
morphine
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• Class IA & III antiarrythmics, other potentially arrhythmogenic
agents, may increase risk of QTc prolongation & torsade de pointe
• Hepatotoxicity
• Application site skin reactions
• Equipotency to oral morphine not established
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Methadone Hydrochloride Tablets (Dolophine)
Dosing
interval
• Every 8 to 12 h
Key
instructions
• Initial dose in opioid non-tolerant patients: 2.5 – 10 mg
• Conversion of opioid-tolerant patients using equianalgesic tables can
result in overdose & death. Use low doses according to table in full PI
• Titrate slowly with dose increases no more frequent than every 3-5 d.
Because of high variability in methadone metabolism, some patients
may require substantially longer periods between dose increases (up to
12 d).
• High inter-patient variability in absorption, metabolism, & relative
analgesic potency
• Opioid detoxification or maintenance treatment only provided in a
federally certified opioid (addiction) treatment program (CFR, Title 42, Sec 8)
• Pharmacokinetic drug-drug interactions w/ methadone are complex
Drug
interactions
− CYP 450 inducers may decrease methadone levels
− CYP 450 inhibitors may increase methadone levels
− Anti-retroviral agents have mixed effects on methadone levels
• Potentially arrhythmogenic agents may increase risk for QTc
prolongation & torsade de pointe
• Benzodiazepines may increase respiratory depression
FDA. Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics. 08/2014.
www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM311290.pdf
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Methadone Hydrochloride Tablets (Dolophine)
cont’d
Opioidtolerant
• Refer to full PI
Productspecific
safety
concerns
• QTc prolongation & torsade de pointe
• Peak respiratory depression occurs later & persists longer than
analgesic effect
• Clearance may increase during pregnancy
• False-positive UDT possible
Relative
potency:
oral
morphine
• Varies depending on patient’s prior opioid experience
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Fentanyl Transdermal System (Duragesic)
12, 25, 37.5*, 50, 62.5*, 75, 87.5*, and 100 mcg/hr
(*These strengths are available only in generic form)
Dosing
interval
• Every 72 h (3 d)
• Use product-specific information for dose conversion from prior
opioid
• Hepatic or renal impairment: use 50% of dose if mild/moderate,
avoid use if severe
• Application
Key
instructions
−
−
−
−
−
Apply to intact/non-irritated/non-irradiated skin on a flat surface
Prep skin by clipping hair, washing site w/ water only
Rotate site of application
Titrate using a minimum of 72 h intervals between dose adjustments
Do not cut
• Avoid exposure to heat
• Avoid accidental contact when holding or caring for children
• Dispose of used/unused patches: fold adhesive side together &
flush down toilet
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Fentanyl Transdermal System (Duragesic), cont’d
Specific contraindications:
• Patients who are not opioid-tolerant
Key instructions
• Management of
− Acute or intermittent pain, or patients who require opioid analgesia for a short time
− Post-operative pain, out-patient, or day surgery
− Mild pain
• CYP3A4 inhibitors may increase fentanyl exposure
Drug interactions
Opioid-tolerant
Product-specific
safety concerns
• CYP3A4 inducers may decrease fentanyl exposure
• Discontinuation of concomitant CYP P450 3A4 inducer may increase
fentanyl plasma concentration
• All doses indicated for opioid-tolerant patients only
• Accidental exposure due to secondary exposure to unwashed/unclothed
application site
• Increased drug exposure w/ increased core body temp or fever
• Bradycardia
• Application site skin reactions
Relative potency:
oral morphine
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• See individual PI for conversion recommendations from prior opioid
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Morphine Sulfate ER-Naltrexone (Embeda)
Capsules 20 mg/0.8 mg, 30 mg/1.2 mg, 50 mg/2 mg, 60 mg/2.4 mg,
80 mg, 3.2 mg, 100 mg/4 mg
Dosing interval
• Once a day or every 12 h
• Initial dose as first opioid: 20 mg/0.8 mg
• Titrate using a minimum of 1-2 d intervals
Key instructions
• Swallow capsules whole (do not chew, crush, or dissolve)
• Crushing or chewing will release morphine, possibly resulting in fatal
overdose, & naltrexone, possibly resulting in withdrawal symptoms
• May open capsule & sprinkle pellets on applesauce for patients who can
reliably swallow without chewing, use immediately
Drug
interactions
• Alcoholic beverages or medications w/ alcohol may result in rapid release
& absorption of potentially fatal dose
• P-gp inhibitors (e.g., quinidine) may increase absorption/exposure of
morphine by ~2-fold
Opioid-tolerant
• 100 mg/4 mg capsule for use in opioid-tolerant patients only
Product-specific
safety concerns
• None
Collaborative for REMS Education
125 | © CO*RE 2015
Hydromorphone Hydrochloride (Exalgo)
ER Tablets 8 mg, 12 mg, 16 mg, 32 mg
Dosing interval
• Once a day
Key instructions
• Use conversion ratios in individual PI
• Start patients w/ moderate hepatic impairment on 25% dose
prescribed for patient w/ normal function
• Renal impairment: start patients w/ moderate on 50% & patients w/
severe on 25% dose prescribed for patient w/ normal function
• Titrate in increments of 4-8 mg using a minimum of 3-4 d intervals
• Swallow tablets whole (do not chew, crush, or dissolve)
• Do not use in patients w/ sulfite allergy (contains sodium
metabisulfite)
Drug interactions
• None
Opioid-tolerant
• All doses are indicated for opioid-tolerant patients only
Product-specific
adverse reactions
• Allergic manifestations to sulfite component
Relative potency:
oral morphine
• ~5:1 oral morphine to hydromorphone oral dose ratio, use conversion
recommendations in individual product information
126 | © CO*RE 2015
Collaborative for REMS Education
63
10/31/2016
Hydrocodone Bitartrate (Hysingla ER)
ER Tablets, 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg, 120mg
Dosing
interval
• Once a day
• Opioid-naïve patients: initiate treatment with 20 mg orally once daily.
• During titration, adjust the dose in increments of 10 mg to 20 mg every 3 to 5
days until adequate analgesia is achieved.
• Swallow tablets whole (do not chew, crush, or dissolve).
Key
instructions
• Consider use of an alternative analgesic in patients who have difficulty
swallowing or have underlying gastrointestinal disorders that may predispose
them to obstruction.
• Take one tablet at a time, with enough water to ensure complete swallowing
immediately after placing in the mouth.
• Use 1/2 of the initial dose and monitor closely for adverse events, such as
respiratory depression and sedation, when administering Hysingla ER to
patients with severe hepatic impairment or patients with moderate to severe
renal impairment.
127 | © CO*RE 2015
Collaborative for REMS Education
Hydrocodone Bitartrate (Hysingla ER), cont’d
• CYP3A4 inhibitors may increase hydrocodone exposure.
• CYP3A4 inducers may decrease hydrocodone exposure.
Drug interactions
• Concomitant use of Hysingla ER with strong laxatives (e.g., Lactulose) that
rapidly increase GI motility may decrease hydrocodone absorption and
result in decreased hydrocodone plasma levels.
• The use of MAO inhibitors or tricyclic antidepressants with Hysingla ER may
increase the effect of either the antidepressant or Hysingla ER.
Opioid-tolerant
• A single dose ≥ 80 mg is only for use in opioid tolerant patients.
• Use with caution in patients with difficulty swallowing the tablet or
underlying gastrointestinal disorders that may predispose patients to
obstruction.
• Esophageal obstruction, dysphagia, and choking have been reported with
Hysingla ER.
Product-specific
safety concerns
• In nursing mothers, discontinue nursing or discontinue drug. QTc
prolongation has been observed with Hysingla ER following daily doses of
160 mg.
• Avoid use in patients with congenital long QTc syndrome. This observation
should be considered in making clinical decisions regarding patient
monitoring when prescribing Hysingla ER in patients with congestive heart
failure, bradyarrhythmias, electrolyte abnormalities, or who are taking
medications that are known to prolong the QTc interval.
• In patients who develop QTc prolongation, consider reducing the dose.
Relative potency:
oral morphine
Collaborative for REMS Education
• See individual PI for conversion recommendations from prior opioid
64
10/31/2016
Morphine Sulfate (Kadian)
ER Capsules 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg, 80 mg,
100 mg, 130mg, 150 mg, 200 mg
Dosing interval
• Once a day or every 12 h
Key instructions
•
•
•
•
Drug interactions
• Alcoholic beverages or medications w/ alcohol may result in rapid
release & absorption of potentially fatal dose of morphine
• P-gp inhibitors (e.g., quinidine) may increase absorption/exposure of
morphine by ~2-fold
Opioid-tolerant
• 100 mg, 130 mg, 150 mg, 200 mg capsules for use in opioid-tolerant
patients only
Product-specific
safety concerns
• None
PI recommends not using as first opioid
Titrate using minimum of 2-d intervals
Swallow capsules whole (do not chew, crush, or dissolve)
May open capsule & sprinkle pellets on applesauce for patients who
can reliably swallow without chewing, use immediately
Collaborative for REMS Education
129 | © CO*RE 2015
Morphine Sulfate (MorphaBond)
ER Tablets 15 mg, 30 mg, 60 mg, 100 mg
Dosing interval
• Every 8 h or every 12h
Key instructions
• Product information recommends not using as first opioid
• Titrate using a minimum of 1 – 2 d intervals
• Swallow tablets whole (do not chew, crush, or dissolve)
Specific Drug
interactions
• P-gp inhibitors (e.g. quinidine) may increase the
absorption/exposure of morphine sulfate by about two-fold
Opioid-tolerant
• MorphaBond 100 mg tablets are for use in opioid-tolerant
patients only
Product-specific
safety concerns
• None
130 | © CO*RE 2015
Collaborative for REMS Education
65
10/31/2016
Morphine Sulfate (MS Contin)
ER Tablets 15 mg, 30 mg, 60 mg, 100 mg, 200mg
Dosing interval
• Every 8 h or every 12 h
• Product information recommends not using as first opioid.
Key instructions
• Titrate using a minimum of 1-2 d intervals
• Swallow tablets whole (do not chew, crush, or dissolve)
Drug interactions
• P-gp inhibitors (e.g., quinidine) may increase
absorption/exposure of morphine by ~2-fold
Opioid-tolerant
• 100 mg & 200 mg tablet strengths for use in opioid-tolerant
patients only
Product-specific
safety concerns
• None
Collaborative for REMS Education
131 | © CO*RE 2015
Tapentadol (Nucynta ER)
ER Tablets 50 mg, 100 mg, 150 mg, 200 mg, 250 mg
Dosing interval
Key instructions
• Every 12 h
50 mg every 12 h is initial dose in opioid non-tolerant patients
Titrate by 50 mg increments using minimum of 3-d intervals
MDD: 500 mg
Swallow tablets whole (do not chew, crush, or dissolve)
Take 1 tablet at a time w/ enough water to ensure complete
swallowing immediately after placing in mouth
• Dose once/d in moderate hepatic impairment (100 mg/d max)
• Avoid use in severe hepatic & renal impairment
•
•
•
•
•
Drug interactions
• Alcoholic beverages or medications w/ alcohol may result in rapid
release & absorption of a potentially fatal dose of tapentadol
• Contraindicated in patients taking MAOIs
Opioid-tolerant
• No product-specific considerations
Product-specific
safety concerns
• Risk of serotonin syndrome
• Angio-edema
Relative potency:
oral morphine
• Equipotency to oral morphine has not been established
132 | © CO*RE 2015
Collaborative for REMS Education
66
10/31/2016
Oxymorphone Hydrochloride (Opana ER)
ER Tablets 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg
Dosing interval
• Every 12 h dosing, some may benefit from asymmetric (different
dose given in AM than in PM) dosing
• Use 5 mg every 12 h as initial dose in opioid non-tolerant patients &
patients w/ mild hepatic impairment & renal impairment (creatinine
clearance <50 mL/min) & patients >65 yrs
Key instructions
• Swallow tablets whole (do not chew, crush, or dissolve)
• Take 1 tablet at a time, w/ enough water to ensure complete
swallowing immediately after placing in mouth
• Titrate in increments of 5-10 mg using a minimum of 3-7 d intervals
• Contraindicated in moderate & severe hepatic impairment
Drug interactions
• Alcoholic beverages or medications w/ alcohol may result in
absorption of a potentially fatal dose of oxymorphone
Opioid-tolerant
• No product-specific considerations
Product-specific
safety concerns
• Use with caution in patients who have difficulty swallowing or
underlying GI disorders that may predispose to obstruction (e.g. small
gastrointestinal lumen)
Relative potency:
oral morphine
• Approximately 3:1 oral morphine to oxymorphone oral dose ratio
Collaborative for REMS Education
133 | © CO*RE 2015
Oxycodone Hydrochloride (OxyContin)
ER Tablets 10mg, 15mg, 20,mg, 30mg, 40mg, 60mg and 80 mg
Dosing interval
NEW
DOSING
INFO
• Every 12 h
• Initial dose in opioid-naïve and non-tolerant patients: 10 mg every 12 h
• Titrate using a minimum of 1-2 d intervals
• Hepatic impairment: start w/ ⅓-½ usual dosage
Key instructions
• Renal impairment (creatinine clearance <60 mL/min): start w/ ½ usual dosage
• Consider other analgesics in patients w/ difficulty swallowing or underlying GI
disorders that predispose to obstruction. Swallow tablets whole (do not chew, crush,
or dissolve)
• Take 1 tablet at a time, w/ enough water to ensure complete swallowing immediately
after placing in mouth
Drug interactions
Opioid-tolerant
Product-specific
safety concerns
Relative potency:
oral morphine
134 | © CO*RE 2015
• CYP3A4 inhibitors may increase oxycodone exposure
• CYP3A4 inducers may decrease oxycodone exposure
• Single dose >40 mg or total daily dose >80 mg for use in opioid-tolerant patients
only
• Choking, gagging, regurgitation, tablets stuck in throat, difficulty swallowing tablet
• Contraindicated in patients w/ GI obstruction
• Approximately 2:1 oral morphine to oxycodone oral dose ratio
Collaborative for REMS Education
67
10/31/2016
Oxycodone Hydrochloride (OxyContin) con’t
ER Tablets 10mg, 15mg, 20,mg, 30mg, 40mg, 60mg and 80 mg
For Adults:
• Single dose greater than 40 mg or total daily dose greater than 80 mg are for use in
adult patients in whom tolerance to an opioid of comparable tolerance has been
established.
• When a dose increase is clinically indicated, the total daily oxycodone dose usually can
be increased by 25% to 50% of the current dose.
Key instructions
For Pediatric Patients (11 years and older)
• For use only in opioid tolerant pediatric patients already receiving and tolerating opioids
for at least five (5) consecutive days with a minimum of 20 mg per day of oxycodone or
its equivalent for at least 2 days immediately preceding dosing with Oxycodon ER.
Renal impairment (creatinine clearance <60 mL/min): start w/ ½ usual dosage
• If needed, pediatric dose may be adjusted in 1 to 2 day intervals.
• When a dose increase is clinically indicated, the total daily oxycodone dose usually can
be increased by 25% of the current daily dose.
•
IMPORTANT:
•
135 | © CO*RE 2015
Opioids are rarely indicated or used to treat pediatric patients with chronic
pain.
The recent FDA approval for this oxycodone formulation was NOT
intended to increase prescribing or use of this drug in pediatric pain
Collaborative
for to
REMS
treatment. Review the product information
and adhere
bestEducation
practices
in the literature.
Oxycodone Hydrochloride/Naloxone
Hydrochloride (Targiniq ER)
ER Tablets 10 mg/5mg, 20 mg/10 mg, 40 mg/20 mg
Dosing interval
• Every 12 h
Key instructions
•
•
•
•
•
Drug
interactions
Opioid-naïve patients: initiate treatment w/ 10mg/5mg every 12 h
Titrate using min of 1-2 d intervals
Do not exceed 80 mg/40 mg total daily dose (40 mg/20 mg q12h)
May be taken w/ or without food
Swallow whole. Do not chew, crush, split, or dissolve: this will release
oxycodone (possible fatal overdose) & naloxone (possible withdrawal)
• Hepatic impairment: contraindicated in moderate-severe impairment. In
patients w/ mild impairment, start w/ ⅓-½ usual dosage
• Renal impairment (creatinine clearance <60 mL/min): start w/ ½ usual dosage
• CYP3A4 inhibitors may increase oxycodone exposure
• CYP3A4 inducers may decrease oxycodone exposure
Opioid-tolerant
• Single dose >40 mg/20 mg or total daily dose of 80 mg/40 mg for opioidtolerant patients only
Product-specific
safety concerns
• Contraindicated in patients w/ moderate-severe hepatic impairment
Relative potency:
• See individual PI for conversion recommendations from prior opioids
oral morphine
Collaborative for REMS Education
136 | © CO*RE 2015
68
10/31/2016
Hydrocodone Bitartrate (Zohydro ER)
ER Capsules 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 50 mg
Dosing interval
• Every 12 h
Key instructions
• Initial dose in opioid non-tolerant patient is 10 mg
• Titrate in increments of 10 mg using a min of 3-7 d intervals
• Swallow capsules whole (do not chew, crush, or dissolve)
Drug interactions
• Alcoholic beverages or medications containing alcohol may result
in rapid release & absorption of a potentially fatal dose of
hydrocodone
• CYP3A4 inhibitors may increase hydrocodone exposure
• CYP3A4 inducers may decrease hydrocodone exposure
Opioid-tolerant
• Single dose >40 mg or total daily dose >80 mg for use in
opioid-tolerant patients only
Product-specific
safety concerns
• None
Relative potency:
oral morphine
• Approximately 1.5:1 oral morphine to hydrocodone oral dose ratio
Collaborative for REMS Education
137 | © CO*RE 2015
Naloxone (Narcan)
Dosing interval
• IM or SQ: onset 2-5 minutes, duration >45 min
• IV: onset 1-2 min, duration 45 minutes
Key instructions
• Monitor respiratory rate
• Monitor level of consciousness for 3-4 hours after expected peak of blood
concentrations
• Note that reversal of analgesia will occur
Drug
interactions
• Larger doses required to reverse effects of buprenorphine, butorphanol,
nalbuphine, or pentazocine
Opioid-tolerant
• Assess signs and symptoms of opioid withdrawal, may occur w-i 2 min – 2 hrs
• Vomiting, restlessness, abdominal cramps, increased BP, temperature
• Severity depends on naloxone dose, opioid involved & degree of dependence
Product-specific
safety concerns
• Ventricular arrhythmias, hypertension, hypotension, nausea & vomiting
• As naloxone plasma levels decrease, sedation from opioid overdose may
increase
138 | © CO*RE 2015
Collaborative for REMS Education
69
10/31/2016
Summary
Prescription opioid abuse & overdose is a national
epidemic. Clinicians must play a role in prevention
Understand how to
assess patients for
treatment
w/ ER/LA opioids
Be familiar w/ how to
initiate therapy,
modify dose, &
discontinue use of
ER/LA opioids
Know how to counsel
patients & caregivers
about the safe
use of ER/LA opioids,
including proper
storage & disposal
139 | © CO*RE 2015
Know how to manage
ongoing therapy w/
ER/LA opioids
Be familiar w/ general
& product-specific
drug information
concerning
ER/LA opioids
Collaborative for REMS Education
IMPORTANT!
Thank you for completing the post-activity
assessment for this CO*RE session.
Your participation in this assessment allows CO*RE
to report de-identified numbers to the FDA.
A strong show of engagement will demonstrate
that clinicians have voluntarily taken this
important education and are committed to
patient safety and improved outcomes.
THANK YOU!
140 | © CO*RE 2015
Collaborative for REMS Education
70
10/31/2016
Thank you!
www.core-rems.org
159 | © CO*RE 2015
Collaborative for REMS Education
71
Osteopathic Manipulation for the Busy Practice
Robert J. Cromley, D.O.
Learning Objectives:
Define a fundamental approach to patients to increase the inclusion of OMM in a
clinical practice.
Describe common clinical scenarios where OMM is underutilized.
Present a practical approach to utilizing OMM in a way to increase usefulness in a
busy practice.
Drugs in America 2016
Robert M. Stutman
Jude Jodi Debbrecht Switalski
Learning Objectives:
Describe the paradigm shift in the US involving substance abuse.
Describe what actions medical professionals can take to better identify and prevent
prescription drug misuse/abuse and diversion.
Discuss what physician liabilities exist for a patient’s addiction to or overdose from
prescription drugs.
Discuss current trends in the use of medication assisted treatments for opioid addition
and the argument for and against their use.
NOTES
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SUNDAY, NOVEMBER 13, 2016 5 credits
7:00 a.m.
Breakfast Buffet - West Pathway
Moderator:
Roger L. Wohlwend, D.O. 7:00 a.m.-9:00 a.m.
Breakfast Buffet Served
8:00 a.m.-9:00 a.m.
Breast Cancer Update 2016:
The Latest in Diagnosis and Treatment
Sarath K. Palakodeti, D.O.
9:00 a.m.-10:00 a.m.
Young , Healthy…and Immortal: Discussing Advance Directives
with Patients Who Don’t Think They Need Them
Laura T. Phillipps, RN, MSN, CHPN
10:00 a.m.-11:00 a.m.
The Basic Principles and History of Hyperbaric Oxygen Therapy
George Thomas Magill, M.D.
11:00 a.m.-12:00 p.m.
TMS Therapy: A Unique and Proven Approach to Treating
Depression
Carlos G. Lowell, D.O.
12:00 pm.-1:00 p.m.
The Anterior Approach to Hip Replacement
Richard M. Miller, D.O., FAOAO
Or
8:00 a.m.-1:00 p.m.
ACLS Recertification - Tamarind Room
Brent C. DeVries, D.O. & Captain David Degnan, Fire Chief
Breast Cancer Update 2016:
The Latest in Diagnosis and Treatment
Sarath K. Palakodeti, D.O.
Learning Objectives:
Identify breast lesions and masses, and know appropriate workup for a breast mass.
List appropriate patient recommendations based on breast imaging BIRADS guidelines.
Recognize the latest in breast cancer diagnosis and treatment.
Young, Healthy…and Immortal:
Discussing Advance Directives with Patients Who
Don’t Think They Need Them
Laura T. Phillipps, RN, MSN, CHPN
Learning Objectives:
Review the evolution of advance directives and advance care planning in our country.
Explain Ohio advance directives forms.
Discuss the advance care planning process with a healthy adult.
NOTES
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________________________________________________
The Basic Principles and History of Hyperbaric Oxygen
Therapy
George Thomas Magill, M.D.
Learning Objectives:
Recognize the basic principles and history of hyperbaric oxygen therapy (HBOT).
Define the role of HBOT in wound healing
Identify the chronic and acute indications for HBOT.
11/10/2016
Introduction to
Hyperbaric Medicine
George Magill, MD
Wound Care Solutions
Bryan Hospital
Bryan, Ohio
CME Disclosure
No relevant financial relationships with commercial interests
Purpose of Presentation
History of Hyperbaric Medicine
Physiology & Pharmacology Of HBO2
Rationale For HBO2 In Wound Healing
HBO Indications
1
11/10/2016
Monoplace chambers are designed for one
patient at a time using 100% Oxygen
2
11/10/2016
The model we are using is easy to operate,
with few moving parts and no
computerization.
3
11/10/2016
We are plumbed for two chambers. One tech
can safely operate two chambers at a time.
 1670:
Robert Boyle
demonstrated that a reduction
in ambient pressure could lead
to bubble formation in living
tissue. This description of a
viper in a vacuum was the first
recorded description of
decompression sickness
4
11/10/2016
Where Did It All Start ?
Interestingly, The Story
Starts With the
Brooklyn Bridge

1873: Andrew Smith first utilized the
term "caisson disease" describing
110 cases of decompression
sickness as the physician in charge
during construction of the Brooklyn
Bridge. The project employed 600
compressed air workers.
Recompression treatment was not
used. The project chief engineer
Washington Roebling suffered from
caisson disease, and endured the
after-effects of the disease for the
rest of his life.
5
11/10/2016
 There
were many reports of
illness associated with
compressed air
environments prior to the
building of the Brooklyn
Bridge, But Smith was the
first to “put it all together”
and write it up.
Caisson Disease
6
11/10/2016
 Launching
Size and weight
of Brooklyn Caisson: 168 x
102 x 14.5 feet; 3000 tons.
Launching Size and weight
of New York Caisson: 172 x
102 x 14.5 feet; 3250 tons
 1900:
Leonard Hill used a frog
model to prove that
decompression causes
bubbles and that
recompression resolves them.
Hill advocated linear or uniform
decompression profiles. This
type of decompression is used
today by saturation divers.
7
11/10/2016
HBOT History

1930s- Used to speed nitrogen removal from
divers

1950s- HBO first used in treatment of tumors.

Life without Blood

1960s- Used to treat gas gangrene and CO
Poisoning

1970s- Committee formed to study Hyperbaric
Oxygen Therapy as approved treatment for
Decompression Sickness, Air Embolism, Carbon
Monoxide Poisoning
Beginning of Modern HBO2

I. Churchill-Davidson, MD (1955) study of
radiosensitivity of tumors
Churchill-Davidson I et al. High pressure oxygen and
radiotherapy. Lancet 1955; 1: 1091-95.
8
11/10/2016
Ite Boerema, MD
Father of Hyperbaric Oxygen
Therapy

Leven Zonder Bloed (1960)

“Life Without
Blood” is possible
under hyperbaric
conditions

Pig study at 3 ata

Paved way for
HBO2 for wounds
Ite Boerema, MD
What is…
Hyperbaric Oxygen
Therapy?

Breathing 100% Oxygen while
pressurized greater than One
Atmosphere (sea level)

Increased pressure causes
Oxygen to dissolve in the
plasma

Substantial increase in tissue
Oxygenation
9
11/10/2016
What does
Hyperbaric Oxygen Therapy
do?

Enhances Wound Healing
through ROS and RNS which..

Stimulates new blood vessel
growth
-increases growth factors,
mobilizes stem cells that form
new blood vessels and…
> Decreases inflammation

Arrests certain types of infections
HBO Chamber
Differences
Multi-place

Monoplace

Larger multi-person

One person

Air Atmosphere

100% oxygen

100% O2 via hood

Mask for air breaks

More acute patients can
be treated

Stable patient

Patient alone in chamber

In chamber tender
10
11/10/2016
Growth in Hyperbaric
Medicine
More Acceptance in Mainstream Medicine
 Published Clinical Trials
 Maturity of the Field



Fellowships

Board Certification
Access to Training


UHMS Approved Introductory Courses in HM
Reimbursed by Medicare/ Medicaid & Private
Insurance
Clinical Hyperbaric Facilities in USA
1400
1200
1000
800
600
400
200
0
1965
1976
1986
1996
2001
2004
2008
2012
Sources: Univ of Maryland, UHMS, CMS, IATMO
11
11/10/2016
Approved NonEmergent Indications

Diabetic Wounds of Lower Extremity

Radiation Tissue Damage

Osteoradionecrosis (ORN)

Chronic Refractory Osteomyelitis

Compromised Skin Grafts and Flaps
Approved Indications










Clostridial Myonecrosis (Gas Gangrene)
Actinomycosis
Air or Gas Embolism
Carbon Monoxide Poisoning
Smoke Inhalation
Decompression Sickness
Severe Anemia
Cyanide Poisoning
Thermal Burns
Crush Injury, Compartment Syndrome &
other acute Traumatic Ischemias
12
11/10/2016
Physiology &
Pharmacology
of HBO2
Pressure in
Atmospheres
Absolute
(ATA)
Most HBO
Treatments
0 ATA
1 ATA
Space
SL
2 ATA
33 fsw
3 ATA
66 fsw
13
11/10/2016
Daltonʼs Law Applies

Total pressure = sum of partial
pressures

PB (air) = PO2 + PN2 + Pothers
2.5
2
pOthers
pN2
pO2
1.5
1
0.5
0
1 ata
2 ata
As total pressure doubles, pO2 doubles
Hyperbaric Oxygen Therapy
is a spin-off of technology for treating DCS
Bubble compression
High dose oxygen
2500
1 ata
2 ata
2000
1500
pO2
1000
3 ata
500
0
1
2
3 ata
14
11/10/2016

The atmospheric pressure decrease at 10,000-foot altitude =
523mm Hg ambient air pressure resulting in 87 percent
hemoglobin saturation and 61mm Hg arterial oxygen.

At 15,000 feet (429mm Hg) the hemoglobin saturation is 80
percent (we need 87-97 percent for normal functioning),
and arterial oxygen is 44mm Hg .
Benefits of HBO2 in Wound
Healing

Hyperoxygenation

Vasoconstriction

Angiogenesis

Leukocyte Oxidative Killing

Antibacterial Effects

Attenuates Reperfusion Injury

Mobilizes Stem Cells
15
11/10/2016
Hyperoxygenation of Tissue
As pressure inside the
chamber increases:
Alveolar PO2
O2 transport
Tissue O2
uptake
Aids healing of
hypoxic wounds
Oxygen Gradient

Between capillary
perfused edge
and wound space

Capillaries


>40 mm Hg
Wound Edge


>40 mm Hg
<20 mm Hg
O2 Gradient
<20 mm Hg
Important for GF
release and
angiogenesis
Photo courtesy of TK
Hunt, MD
16
11/10/2016
O2 Electrodes Confirm:
Problem Wounds Have Low
PO2
Patient 946OP: Amputation of 2 Toes on Left Foot
Air
30
02
Air
02
Air
02
Air
20
Wound
at 1 ATA
10
0
10
20
5
20
5
20
10
Sheffield PJ, 1985
Time interval (min)
O2 Electrodes Confirm:
HBO2 Elevates Wound PO2
Patient 603EM: Radiation necrosis over sacrum
Weekly wound response at 1 ata & 2.4 ata
1 ata
2.4 ata
PO2 (mm Hg)
O2
O2
1 ata
O2
1500
1000
O2
O2
O2
4 wks HBO2
500
1 wk HBO2
0
0
30
60
90
120
150
Lapse time (min)
180
210
Sheffield PJ, 1985
17
11/10/2016
HBO2 Effect on Plasma O2
Vol % = ml O2 / 100 cc plasma
Pressure
(ata)
1.0
V ol % in
Plasm a (air)
0.3
V ol % in
Plasm a (O 2)
2.1
2.0
0.8
4.4
2.4
1.0
5.2
3.0
1.3
6.8
Effect on Microorganisms:
Leukocyte Oxidative
Killing

Leukocytes

Improved phagocytosis

Neutrophil-generated high energy oxygen radicals

Protected by superoxide dismutase enzyme system
Mandell G, 1974

Gas Gangrene (Clostridium perfringens)

Alpha toxin ceases when pO2 > 250mmHg

Bactericidal when pO2 >1500 mmHg
Van Unnik AJM, 1965
18
11/10/2016
Effect on Microorganisms:
Antibacterial Effects
Count



Converts anaerobic
wounds with low pH to
aerobic wounds with
normal pH
Some antibiotics do not
work well in acid pH
HBO2 + tobramycin best
eradicates Pseudomonis
aeruginosa from infected
bone
7
6
Control
5
HBO2
4
TM
3
2
HBO2 +
TM
1
0
Mader JT, et al, 1987
21
28
35
42 Days
HBO2 Attenuates Reperfusion Injury

Direct injury from severe hypoxia
Indirect injury from
prolonged ischemia
- Inappropriate activation of
leukocytes
- Neutrophils block venules
& prevent flow
HBO2 protects tissue from reperfusion injury
- Inhibits sequestration of neutrophils in venules
- Prevents “no reflow”
Zamboni WA, et al, 1989
19
11/10/2016
HBO2 stimulates stem cell mobilization
from bone marrow and more cells are
recruited to the skin wounds




HBO2 mobilizes stem/ progenitor cells by
stimulating •NO synthesis
Circulating stem cells doubled after HBO
Nitric oxide synthase activity increased in
platelets and remained elevated > 20 hrs
Adult stem cells repair and remodel the
tissue in which they are found
Thom SR, et al. Vasculogenic stem cell mobilization and wound recruitment in
diabetic patients: increased cell number and intracellular regulatory protein content
associated with hyperbaric oxygen therapy. Wound Repair Regen, 2011 Mar;19(2):
149-61.
What is the Evidence for
HBOT in Diabetic Foot Ulcers?

10 published, independent, evidence based
reviews for HBO in DFUs

7 RCT, 2 CT, 7 retrospective case series all with
different end points, patient selection criteria,
protocols, endpoints.

Despite the differences, HBO was consistently
shown to be beneficial.

Margolis et al. is one of the few dissenting papers.
This retrospective study had many limitations.
Included Wagner 1, 2 and 3 Ulcers.
20
11/10/2016
What is the Evidence for
HBOT in Radiation Injuries?

Used for more than 30 years as therapy for
delayed radiation injury.

Stimulates angiogenesis, reduces fibrosis, and
mobilizes/increases stem cells in irradiated tissues.

Radiation induced mandibular necrosis responds
well to HBOT when combined with surgical
excision of necrotic bone.
Delayed Radiation Injuries

Robert Marx, DDS has done the most definitive
work on the role of HBOT in mandibular necrosis.
He established that the majority of the HBO
treatments need to happen BEFORE surgical
removal of all necrotic bone.

Marx reports a 100% success rate on 268 patients
using a well-defined protocol.

There have been negative reports, usually these
did NOT follow Marx’s guidelines and total less
than 60 patients.
21
11/10/2016
Burn Wound Angiogenesis
Ketchum et al 1969

Scald wound
on back of rat
at 22 days
- HBO2
treated

Control
Ketchum etal 1969: Angiographic studies of the effects of
HBO on burn wound revascularization. Proceedings of 4th
Int Cong on Hyperb Med. Baltimore, Williams &
Wilkins;388-394.
Patient Selection is Very
Important

Patients Who
Will Heal
Without HBOT
Patients Who
Might Heal With
HBOT

Patients Who
Will Not Heal
Even With
HBOT
22
11/10/2016
HBO2 As A Drug

Complications & Side
Effects
Absolute
Contraindications

Untreated
pneumothorax

Selected medications

Doxorubicin
(Adriamycin®)

Mafenide Acetate
(Sulfamylon®)

Confinement Anxiety

Barotrauma


Ears, sinuses, lungs
O2 toxicity

Eyes, brain, lungs
Kindwall EP, Whelan HT, 2008
CNS Oxygen Toxicity
Time / dose relationship
 Exposure: 100% O2 at >2.0 ata
 Incidence: 1 per 10,000 patient tx

5
4
ATA 3
2
Risk of Seizure
Safe Zone
1
1
2
3
4
Hours
23
11/10/2016
PtcO2 <40 mmHg
Healing
Impaired
 38
studies 1982 - 2009
 Defined PtcO2 < 40 mm Hg
(on air) as hypoxia sufficient
to impair or prevent healing

Fife CE et al . Transcutaneous oximetry in clinical practice.
Consensus statements from an expert panel based on
evidence. UHM 2009; 36(1): 43-53.
What Does Tissue Oximetry
Do?
TCOM

Measures tissue PO2


Approximates capillary PO2
Identifies

Tissue that is hypoxic

Tissue that responds to O2

Nutritive oxygen value
24
11/10/2016
Conducting A TCOM Assessment
of Wound Healing Potential

Question 1: Is wound healing complicated by
hypoxia?
Test 1: Baseline - Air

[Air at 1 atm abs]

> 40
Adequate to heal

31-40
Mild hypoxia

21-30
Moderate hypoxia

11-20
Severe hypoxia

0-10
Profound hypoxia
Positive test for healing: PtcO2 > 40 mm Hg

Conducting A TCOM
Assessment of Wound Healing
Potential

Question 2: Is wound healing complicated
by peripheral arterial occlusive disease?

Test 2: Leg Elevation 30o
[Air at 1 atm abs]

Positive test: Sustained 10% decrease is significant

Disease is present if PtcO2 remains diminished while leg is elevated
25
11/10/2016
Conducting A TCOM Assessment of
Wound Healing Potential
 Question
3: Does the patientʼs wound
site respond to oxygen breathing?

Test 3: O2 Challenge
[O2 at 1 atm abs]

Positive test for healing w/HBO2:
 Mean
>
O2 value > 35 mm Hg
50% rise above air value
Conducting A TCOM Assessment of
Wound Healing Potential
 Question
4: Does the patientʼs wound
site respond to hyperbaric oxygen?

Test 4: HBO2 challenge
[O2 at 2-2.5 atm abs]

Positive test for healing w/ HBO2:
Achieve
>200 mm Hg
26
11/10/2016
Conclusions of the Cohort
Study:
PtcO2 as a Predictor of Healing
Outcome

Best parameters for predicting healing w/ HBO2:
TC-O2
>35 mmHg and TC % Rise >50%
Sheffield PJ et al. Mean PtcO2 values as an outcome predictor in hyperbaric
oxygen treatment of hypoxic wounds, UHM 2008; 35(4): 272 abstract.
In-Chamber Oxygen Dose Outcome:
6 Center Study in Diabetic Wounds
(n=222)

Retrospective analysis of 1144 diabetic
foot ulcer patient outcomes

Likelihood of benefiting from HBO2 > 90%
when in-chamber PtcO2 was >200 mm
Hg
Fife et al (2002)
27
11/10/2016
Documentation

Failed 30 days of standard therapy

No improvement with standard therapy during the previous
30 days.

Wagner 3 with infection

Hemoglobin A 1 C (Controlled blood sugars)

Blood glucose levels before and after treatment

Vascular assessment

Control of infection

Offloading

Optimize nutritional status

Physician supervision

ACLS immediately available
28
TMS Therapy: A Unique and Proven Approach to
Treating Depression
Carlos G. Lowell, D.O.
Learning Objectives:
Describe TMS therapy.
Discuss when you would consider referring a patient for TMS therapy.
Recognize what excludes a patient from being a TMS therapy candidate.
Define mechanism of action for TMS-How does it work?
10/31/2016
TMS THERAPY:
A UNIQUE AND PROVEN APPROACH
TO TREATING DEPRESSION
CARLOS G. LOWELL, D.O.
DES MOINES UNIVERSITY
COLLEGE OF OSTEOPATHIC MEDICINE
FIRELANDS REGIONAL MEDICAL CENTER
D.O. ROTATING INTERNSHIP
MEDICAL COLLEGE OF WISCONSIN
PSYCHIATRIC RESIDENCY
TMS INSTITUTE OF OHIO
MEDICAL DIRECTOR
2
1
10/31/2016
DISCLOSURES:
I HAVE NO CONSULTING CONTRACTS WITH ANY TMS MANUFACTURERS OR
PHARMACEUTICAL COMPANIES. NOR DO I HAVE ANY GOVERNMENT GRANTS.
3
THE BIOLOGY
OF DEPRESSION
2
10/31/2016
Major Depression is a Brain Disease
5
Major Depressive Disorder
prefrontal
cortex
anterior
cingulate
cortex
striatum
hypothalamus
HIGH
thalamus
Neural
Activity
LOW
amygdala
brainstem
neurotransmitter
centers
In MDD, some
areas of the
brain are
hypoactive and
others are
hyperactive.
hippocampus
6
3
10/31/2016
Major Depressive Disorder:
Circuits and Neurotransmitters
concentration
pleasure/
interests
psychomotor
fatigue
monoamine
(mental)
neurotransmitter
guilt
projections
suicidality
worthlessness
psychomotor fatigue
(physical)
pleasure/interests
sleepare
Regions implicated in MDD
appetite
connected to the brainstem
via monoaminergic circuits
mood
guilt
suicidality
worthlessness
mood
Monoamine
Neurotransmitters
Serotonin (5-HT)
Dopamine (DA)
When there is
appropriate
• an
Monoamine
amount ofis
dysfunction
monoamine
linked
to MDD
neurotransmitter
• Malfunctioning
activity,
circuits lead
to
neuronal
activity
specific
throughout
the
symptoms
brain
functions
normally.
Norepinephrine (NE)
7
STAR*D Treatment Algorithm
8
4
10/31/2016
Study demonstrates that medication
treatment have limited effectiveness
Trivedi (2006) Am J Psychiatry; Rush (2006) Am J Psychiatry; Fava (2006) Am J Psychiatry; McGrath (2006) Am J Psychiatry
9
Study also demonstrates the discontinuing
treatment increases with each NEW medication
Systemic Drug Side Effects

Weight Gain

Fatigue

Constipation

Headache/
Migraine

Diarrhea


Nausea
Abnormal
Ejaculation

Drowsiness

Impotence

Insomnia

Sweating

Decreased
Libido

Tremor

Treatment
Discontinuation
Side Effects

Weakness

Dry Mouth

Dizziness

Nervous Anxiety

Increased
Appetite

Decreased
Appetite
Trivedi (2006) Am J Psychiatry; Rush (2006) Am J Psychiatry; Fava (2006) Am J Psychiatry; McGrath (2006) Am J
Psychiatry; Neuronetics, Inc. (data on file)
10
10
5
10/31/2016
Chemical Antidepressants
Antidepressant
TherapeuticSide
Effects
Effects
suchsuch as:
increased
as :
blurred vision
concentration
agitation
insomnia
dry mouth
nausea
GI
distress
improved
mood
sexual
dysfunction
Antidepressant
insomnia
fatigue
blood
pressure
changes
weight gain
reduced feelings of
guilt, suicidality,
weight
and worthlessness
gain
11
Medication May Not Work for Everyone!
STAR*D study sponsored by NIMH using antidepressant
medications shows:
When patients don’t benefit from
antidepressant medication…
… their chances of getting better from
additional medication treatments
declines
… they are more likely to stop a
medication due to unwanted side
effects
12
6
10/31/2016
TRANSCRANIAL MAGNETIC
STIMULATION:
MECHANISM OF ACTION
Science Behind TMS Started in 1831 with
Michael Faraday
The physical principles of
TMS were discovered in
1831 by Michael Faraday,
who observed that a pulse of
electric current passing
through wire coil generates a
magnetic field.
The rate of change of this
magnetic field determines
the induction of a secondary
current in a nearby
conductor.
This current in turn depolarizes
neurons and can generate
various physiological and
behavioral effects depending
on the targeted brain area.
The conductors in TMS are
neurons in the brain, allowing
electrical stimulation in the
brain in a non-invasive fashion.
14
7
10/31/2016
TMS Therapy Directly Depolarizes
Cortical Neurons
Neuron
Pulsed magnetic fields:
• induce a local electric
current in the cortex
which depolarizes
neurons
• eliciting action
potentials
• causing the release of
chemical
neurotransmitters
Neurons are
“electrochemical cells”
and respond to either
electrical or chemical
stimulation
15
TMS RELEASES Neurotransmitters in the
Brain
Depolarization of neurons in
the DLPFC causes local
neurotransmitter release
Dorsolateral
These
prefrontal
cortex
effects are
associated with
Anterior
improvements in
cingulate
cortex depressive
symptoms
Kito (2008) J Neuropsychiatry Clin Neurosci
Depolarization of pyramidal
neurons in the DLPFC also causes
neurotransmitter release in deeper
brain neurons
Activation of deeper brain neurons
then exerts secondary effects on
remaining portions of targeted
mood circuits
16
8
10/31/2016
Targeted Effects on Mood Circuits in Brain
R
L
TMS Coil
L
R
Activation of fronto-cingulate brain circuit following a
course of TMS applied to the left dorsolateral prefrontal
cortex in patients with Major Depression
Kito (2008) J Neuropsychiatry Clin Neurosci
17
Biological and Behavioral Effects of TMS
Effects Seen After Chronic Exposure:
 Specific outcome is dependent upon stimulation parameters
 Alteration of monoamine concentrations
 Beta-receptor, serotonin-receptor modulation
 Evidence of induction of neurogenesis genes (eg, BDNF)
 Plasticity-like actions (ie, LTD/LTP-like effects)
 Local GABA, glutamate effects
 Stimulation of the dorsolateral prefrontal cortex (DLPFC) alters functional activity of the
anterior cingulate (AC) and deeper limbic regions
18
9
10/31/2016
TMS Increases Neurogenesis in Hippocampal
Dentate Gyrus
Ueyama, et al., 2011
19
TMS Restrains the Activation of HPA Axis
During Chronic Stress
Czeh, B., et al., Biol Psychiatry. 2002;52:1057-1065
20
10
10/31/2016
NeuroStar TMS
Therapy System
Magstim System
Brainsway TMS Device
Magventur System
21
TMS Therapy Session
 Patient is awake and alert
 No anesthesia or sedation
needed
 No negative effects on thinking and
memory
 After treatment, patients can
drive or return to work
 Some patients experience headache
or mild to moderate pain or
discomfort at or near the treatment
area
 None of the side effects typical with
antidepressant medications
22
11
10/31/2016
TMS: Contraindications
 Non-removable metallic objects in or around the head
 Conductive, ferromagnetic or other magnetic sensitive metals
that are implanted or are non-removable within 30 cm of
treatment coil
 Implanted electrodes/ stimulators
 Deep Brain Stimulator
 Aneurysm clips or coils
 Cochlear implants
 Stents
 Bullet or other metal fragments
NeuroStar TMS Therapy System User Manual. Neuronetics, Inc: Malvern, PA.
23
TMS Therapy:
A Well-Tolerated Antidepressant
(Adverse Events with Incidence > 5%)
24
12
10/31/2016
Time Course for Most Common Adverse
Events
Janicak PG et al. J Clin Psychiatry. 2008;69(2):222232.
25
Potential Serious Adverse
Events

Cognition

Suicide Ideation

Seizures
26
13
10/31/2016
TMS and Cognition
Data on file. Neuronetics, Inc.
27
Emergence of Suicidal Ideation:
Multicenter Study
28
14
10/31/2016
TMS and Seizures
 Seizure is the most serious side effect associated
with TMS
 Most cases associated with TMS were prior to the
publication of the TMS safety guidelines in 1998
 Considering the large number of healthy individuals
and patients who have undergone TMS sessions
since 1998 and the small number of seizures
reported, the risk of TMS to induce seizures could be
considered very low.
Wassermann, E. Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International
Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5–7, 1996. Electroencephalography and Clinical
Neurophysiology, 108, 1998
29
SCIENTIFIC EVIDENCE OF
EFFICACY
FOR
TMS THERAPY
15
10/31/2016
Large-Scale Randomized Controlled Trials
(RCT’s)




Four large-scale studies (sample size > 100)
Two large multicenter industry supported trials that lead to
FDA approval for two devices
One NIH-funded study with dosage parameters similar to
those in the industry-sponsored study but with sham design
enhancements
One European study of the augmentation effects of TMS when
used in combination with pharmacotherapy
George et al., Archives of General Psychiatry. 2010(67);507-516
Herwig et al., British Journal Psychiatry. 2007;191, 441-448
Levkovitz et al., World Psychiatry. 2015(14); 64-73
O’Reardon et al., Biological Psychiatry. 2008(62); 1208-1216
31
Repetitive Transcranial Magnetic Stimulation
for Treatment-Resistant Depression: A
Systematic Review and Meta-Analysis
 Evaluate the efficacy of TMS in patients with treatmentresistant depression (TRD)
 Included 18 TRD studies published from Jan 1980 –
March 2013
 Those receiving TMS were 3 times more likely to
respond and 5 times more likely to obtain remission vs.
those who received sham
JBN Gaynes et al., Clin Psychiatry 2014;75(5):477–489
32
16
10/31/2016
Multisite Naturalistic Observational Study of TMS for
MDD: Acute Treatment Outcomes and One-Year Follow-Up
Study Goal: Define real world outcomes associated with TMS
Therapy across a broad spectrum of patients and practitioners
42 Sites: Comprised of
institutions and private
practice
Acute Phase
Acute Phase
(treatment
course
Treatment
course
driven by
patient
response
drivenclinical
by patient
clinical response)
307 Patients: Unipolar, nonpsychotic MDD patients in acute
phase
Long-term Outcomes
Measured at 3, 6, 9 and 12 months
Carpenter, Depression and Anxiety, 2012; Dunner, et al., (2014) J. Clin Psych
33
Patients Who Entered Study Had
Significant Morbidity
Carpenter, Depression and Anxiety, 2012
34
17
10/31/2016
% of Patients (N=307)
Comparison of End of Acute Treatment Clinical Status:
Clinician-and Patient-Assessed Outcomes
80
Clinician Rating
(CGI-Severity of Illness)
80
Patient Rating
(PHQ-9 Scale)
70
70
58.0%
60
56.4%
60
50
50
40
40
30
30
20
20
10
10
0
0
Baseline
Baseline
End of Treatment
End of Treatment
LOCF Analysis of intent-to-treat population
Markedly ill or worse
Moderately ill
Mildly ill or better
35
Carpenter, et al, (2012) Depression and Anxiety
Remission is Possible with TMS Therapy:
1 in 2 Patients Respond, 1 in 3 Achieve Remission
Percent of Patients
(N=307)
70
60
Clinician Rating
(CGI-Severity of Illness)
Patient Rating
(PHQ-9 Scale)
56.4%
58.0%
50
40
37.1%
28.7%
30
20
10
0
Responders (CGI-S ≤3, PHQ-9
<10)
Remitters (CGI-S ≤2, PHQ-9
<5)
LOCF Analysis of intent-to-treat population
Carpenter (2012), Depression and Anxiety
36
18
10/31/2016
Long-Term Phase Results at 12 Months
70
Clinician Rating
(CGI-Severity of Illness)
67.7%
60.7%
Percent of Patients
N=257
60
50
45.1%
Patient Rating
(PHQ-9 Scale)
44%
40
37%
30
20
Outcomes measured for one
year following end of acute
treatment
 Physician directed standard of care
 36.2% of patients received TMS
reintroduction
 Average number of TMS treatment
days = 16
10
0
Responders (CGI-S ≤3, PHQ-9
<10)
Remitters (CGI-S ≤2, PHQ-9
<5)
Long term durability of effect has
not been established in a
controlled trial
37
Dunner, et al., (2014) J. Clin Psych
Why are Real World Results Better than
Clinical Trial Results?
 Combination Strategies
 Well tolerated with medication
Biological
 Psychotherapy
 Engagement in Life
 Intensive Outpatient Program – Factors
 Routine
 Interaction
 Engaging with People who Care
Social
Psychological
38
19
10/31/2016
Maintenance TMS
■ No approved maintenance protocol
■ Do not need full course
■ If treat with re-emergence of depression, TMS is more effective with fewer
number of treatments
“It is notable that TMS reintroduction was successful in rescuing most patients
with threshold deterioration and returning them to their prior level of depressive
symptom relief.”
Important observation given:
•
The chronic and relapsing nature of pharmacoresistant major depression
•
Absence of definitive data suggesting that re-treatment with previously effective medications
is capable of doing the same.
The results provide support for long-term treatment strategy that incorporates retreatment with
TMS for patients who showed positive response to an initial acute course. (p.257)
N.S Phillip et al., Brain Stimulation 2016;9:251-257
39
40
20
10/31/2016
WHO MAY BE
CANDIDATES FOR
TMS THERAPY?
Why Do We Need to Consider
Neuromodulation as Treatment Option?
 Depression is a common mental disorder. Globally, more
than 350 million people of all ages suffer from
depression.
 Depression is the leading cause of disability worldwide,
and is a major contributor to the burden of disease.
 ~50% individuals diagnosed seek help and more than
30% do not receive adequate treatment from medication
or psychotherapy
42
21
10/31/2016
STAR-D Data Supports Need for Other Treatment Options
**After 6 weeks of acute phase treatment, NeuroStar
TMS Therapy achieved statistically significantly superior
outcomes as measured by QIDS-SR total scores
compared to next choice antidepressant medication
treatment, when compared to a propensity score
matched sample of patients in the STAR*D Study.
Demitrack, et al., 2013
43
Who is Right for TMS Therapy?
Indicated for:
•TMS Therapy is indicated for the treatment of Major Depressive
Disorder in adult patients who have failed to receive satisfactory
improvement from prior antidepressant medications at or above the
minimal effective dose and duration in the current episode
Patient Characteristics:
•In a recurrent episode
•Multiple medication attempts, yet still symptomatic
•Considering a complex drug regimen
•Experience frequent side effects from medication
Carpenter, et al. (2012), Depression and Anxiety
44
22
10/31/2016
TMS is Included in Practice Guidelines
Following Failure of Initial Treatment
Schlaepfer, et al. World J Biol Psychiatry (2009); Kennedy, et al J Aff Disorders (2009); Institute for Clinical Systems Improvement (2010); American Psychiatric Association (2010)
45
TMS Insurance Coverage
248.4 M Covered Lives
 TMS has coverage in every state for Major
Depressive Disorder
 Covered by all major private insurance
companies
 Covered by Medicare in every state
 Coverage policies vary, but most typically
require a failure of 3-6 antidepressant
medications from different classes and
Psychotherapy
46
23
10/31/2016
Conclusion
 TMS is focal non-invasive form of brain stimulation based on
principles of electromagnetic induction that has been well
established for nearly 200 years.
 TMS is a safe and effective treatment of moderate to severe
MDD and research supporting it’s efficacy in treatment of other
mental and neurological disorders.
 TMS is well-tolerated and without risks of systemic side effects
seen with medications.
 TMS needs to be considered as a treatment option.
47
24
The Anterior Approach to Hip Replacement
Richard M. Miller, D.O., FAOAO
Learning Objectives:
Describe the history of anterior hip replacement.
Recognize the difference between the traditional approach vs the anterior approach.
Identify the anticipated results of the anterior approach.
NOTES
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_________________________________________________
_________________________________________________
_________________________________________________
_________________________________________________
_________________________________________________
_________________________________________________
_________________________________________________
_________________________________________________
_________________________________________________
_________________________________________________
_________________________________________________
_________________________________________________
_________________________________________________
_________________________________________________
_________________________________________________
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_________________________________________________
________________________________________________
ACLS Re-Certification
Brent C. DeVries, D.O.
&
Captain David Degnan, Fire Chief
Learning Objectives:
Respond to and initiate early management of peri-arrest conditions that may result
in cardiac arrest or complicate resuscitation outcome.
Respond to unresponsive victim initiating high-quality CPR skills/appropriate
airway management.
Respond appropriately to Respiratory Arrest with a Pulse/w/o a Pulse.
Respond appropriately to Ventricular Fibrillation/Pulseless VT (AED).
NOTES
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