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Transcript
Drug Therapy
ADVISORY
FDA Alert: Injections Associated
with Fungal Meningitis
(Sean Krohn, PharmD Candidate 2013, NEOMED and Paul Bandfield, PharmD,
Formulary Management Services)
 Methylprednisolone and triamcinolone acetonide injections
compounded by a Massachusetts pharmacy, New England
Compounding Center (NECC), have gained attention in the
national media
o Kaiser Permanente is NOT affiliated with the NECC and does
NOT purchase products from this pharmacy
o Kaiser Permanente has a rigorous process for approving
compounding vendors and only contract with a select
number of compounding pharmacies
 The Centers for Disease Control and Prevention (CDC) is
working with the New England Compounding Center to contact
patients who were potentially infected
 Federal health authorities said that prior to the recall,
hundreds of vials were distributed to many medical facilities
across the United States between May-September
 The steroid injections are injected into the lower back and
travel to the brain via the cerebrospinal fluid
 Symptoms may not appear until 2-4 weeks after exposure and
include fever, headache, neck pain, nausea, vomiting, confusion,
and stroke-like symptoms
 If caught early, the disease can be treated with antifungal
therapy
 Those infected are mainly the elderly with weakened immune
systems, patients receiving chemotherapy, patients with asthma or
cystic fibrosis or transplant patients
 Fungal meningitis is NOT contagious
 All products compounded at and distributed by the New
England Compounding Center have been recalled
 More information can be found at:
http://www.cdc.gov/hai/outbreaks/meningitis.html and
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAler
tsforHumanMedicalProducts/ucm322849.htm
Updates to the Beers Criteria
(H. Paige Stewart, PharmD, Pharmacy Practice Resident)
 The Beers Criteria for Potentially Inappropriate Medication Use
in Older Adults has been revised from the edition published in
2003
o The 2012 revision was released in August
o The authors intend to update the list every 3 years
 “Older Adults” are defined as people age 65 or older
 The revision of the criteria consisted of:
o Medication removal due to elimination from the market,
lack of evidence, or evidence indicating the warning is not
unique to the elderly population
o Medication addition as a result of new drug approvals and
increased evidence published
o Additions and removals for drug-disease state interactions
o Additional table column indicating strength of evidence
supporting recommendation
Issue 10
October 2012
Network Edition
o Added “Use with caution” category
 Medications of note added to the criteria list:
o All short-acting benzodiazepines regardless of dose
 Increases risk for cognitive impairment, delirium, falls,
fractures, and motor vehicle accidents
 Avoid for treatment of insomnia, agitation, or delirium
o Nonbenzodiazepine hypnotics (e.g. zolpidem, zaleplon)
 Increases risk for cognitive impairment, delirium, falls,
fractures, and motor vehicle accidents
o Sliding scale insulin
 Increased risk of hypoglycemia without improving
hyperglycemia
o Long acting sulfonylureas — chlorpropamide and glyburide
 Chlorpropamide — extended half-life in older adults;
may potentiate hypoglycemia and causes syndrome of
inappropriate antidiuretic hormone (SIADH)
 Glyburide — increased risk of hypoglycemia in older
adults
o Metoclopramide
 Increases risk of extrapyramidal side effects including
tardive dyskinesia; risk further increased in frail older
adults
 Avoid unless for gastroparesis
 Noted additions to drug-disease interactions
o Rosiglitazone and pioglitazone with heart failure
o Serotonin reuptake inhibitors in history of falls or fractures
o Antipsychotics for behavioral problems of dementia
o Anticholinergics to treat extrapyramidal side effects of
antipsychotics or to treat Parkinson’s disease (benztropine
and trihexyphenidyl)
 For complete list of The Beers Criteria with revisions, visit:
http://americangeriatrics.org/health_care_professionals/clinical
_practice/clinical_guidelines_recommendations/
Pantoprazole Added to
Commercial Formulary
(Alex Luli, PharmD Candidate 2013, NEOMED and Paul Bandfield, PharmD,
Formulary Management Services)
 Pantoprazole 20mg and 40mg delayed-release tablets will be
added to Commercial formulary, effective November 6, 2012
 Studies have shown that pantoprazole 40mg is equally effective
as omeprazole 20mg for various indications
 Pantoprazole inhibits CYP2C19 the least of all the Proton Pump
Inhibitors (PPIs)
o Omeprazole is the most potent inhibitor of CYP2C19 of all
the PPIs
o The concomitant use of clopidogrel and omeprazole may
result in the diminished effect of clopidogrel
o Pantoprazole is preferred over omeprazole in patient’s
taking other drugs that are metabolized via CYP2C19
(clopidogrel and citalopram) who require PPI therapy
o At approved doses, pantoprazole does not significantly alter
active clopidogrel levels and no dosage adjustment is
necessary per the pantoprazole prescribing information
(Continued on reverse side)
Issue 10 — Network Edition
(Continued from reverse side)
Avoid NSAIDS in Patients with
Chronic Kidney Disease
(Carina Haught, PharmD Candidate 2013, Ohio Northern University and Paul
Bandfield, PharmD, Formulary Management Services)
 Chronic kidney disease (CKD) is defined as the irreversible
loss of renal function as a result of reduced glomerular filtration
rate (GFR) and metabolic waste buildup in the blood
 CKD is classified in 5 stages
o Stage 1: GFR of > 90
o Stage 2: Mild; GFR of 60 to 89
o Stage 3: Moderate; GFR of 30 to 59
o Stage 4: Severe; GFR of 15 to 29
o Stage 5: Kidney failure; GFR <15
 Non-steroidal anti-inflammatory drugs (NSAIDs) generally
should be avoided in patients with CKD
o Especially avoid in patients with Stage 3, 4 or 5 CKD
o Except low dose aspirin for cardiovascular indications
 NSAIDs inhibit prostaglandin synthesis causing additional
reduction in renal blood flow
o Can also cause sodium retention, edema, HTN and
hyperkalemia
 NSAIDs can also reduce the effectiveness of ACE inhibitors,
angiotensin receptor blockers and loop diuretics
 Patients may not be aware that over-the-counter (OTC)
NSAIDs can also exacerbate kidney damage
 Researchers for the CDC found that 5% of people with
moderate to severe kidney disease used OTC NSAIDs regularly
o 11% of patients with moderate to severe kidney disease had
prescriptions for NSAIDs
 Alternatives to NSAIDs
o Acetaminophen (Tylenol)
o Opioids
o Low dose prednisone
Other FDA Alerts
Hospira Lactated Ringer's And 5% Dextrose Injection, 1000
Ml, Flexible Containers: Recall - Mold Contamination
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAler
tsforHumanMedicalProducts/ucm322966.htm
Initiatives
Inter-Regional Clinical Pharmacy Services
Subcommittee (ICPSS) Initiatives
 OxyContin use discouraged over other long-acting opioids
 Generic statin agents preferred over brand statin agents (i.e.,
Atorvastatin preferred over Vytorin and Crestor)
 Regular Insulin preferred over Analog/Combo Insulin agents
 Generic atypical antipsychotic agents preferred over brand
 Boceprevir (Victrelis) preferred over Telaprevir (Incivek)
 Skeletal muscle relaxant use discouraged in elderly
 Hydroxyzine use discouraged in elderly
Pharmacy Conversion Team Projects
 Half-Tab Initiatives
 Bupropion immediate release to Bupropion extended release
October 2012
Current Half-Tab Initiatives
Abilify
Crestor
Levitra
Nuvigil
Viagra
Aricept
Imitrex
Lexapro* Paxil
Zocor
Celexa
Lamictal
Lipitor
Provigil* Zoloft
*Both brand and generic tablet products are half-tab initiatives
Formulary Changes
The Ohio Regional Pharmacy & Therapeutics Committee approved
the following formulary changes. The KP Ohio Region Drug
Formulary is available by accessing the Lexicomp Online Formulary:
 The KP Ohio Region Drug Formulary is available by accessing the
Lexicomp Online Formulary through the Internet
(http://online.lexi.com/login) using login and password: ohkprx
 Formulary changes are updated in Lexicomp on their respective
effective dates
Commercial Additions
Drug
Pantoprazole (generic Protonix) 20mg, 40mg
Cap
Raltegravir (Isentress) 25mg, 100mg Chw Tab
Effective Date
11.6.12
10.2.12
Commercial Deletions
Drug
Triamcinolone Acetonide (Kenalog) Aerosol
Spray
Effective Date
11.6.12
Medicare Part D Additions
Drug
Aclidinium Bromide (Tudorza Pressair)
400mcg/actuation Inh
Amylase/Lipase/Protease [Pancrelipase]
(Viokace) 39,150U, 78,300U Tab
Bosutinib (Bosulif) 100mg, 500mg Tab
Enzalutamide (Xtandi) 40mg Cap
Mirabegron (Myrbetriq) 25mg, 50mg ER Tab
Prednisone (Rayos) 1mg, 2mg, 5mg Delayed
Release Tab
Raltegravir (Isentress) 25mg, 100mg Chw
Tab
Rotigotine (Neupro) 1mg/24hr, 2mg/24hr,
3mg/24hr, 4mg/24hr, 6mg/24hr, 8mg/24hr
Transdermal Patch
Sumatriptan (Sumavel Dosepro) 12 mg/mL
Prefilled Syr
Teriflunomide (Aubagio) 7mg, 14mg Tab
Effective DateNew Tier
10.2.12 - Tier 4
10.2.12 - Tier 4
10.2.12 - Tier 5
10.2.12 - Tier 5
10.2.12 - Tier 4
10.2.12 - Tier 4
10.2.12 - Tier 5
10.2.12 - Tier 4
10.2.12 - Tier 4
10.2.12 - Tier 5
Criteria Updates
Aprepitant (Emend)
Budesonide Enteric Coated Capsule (Entocort
EC)
Itraconazole (Sporanox) and Ciclopirox
Olamine (Penlac)
Milnacipran (Savella)
Oral Proton Pump Inhibitors
Serotonin 5HT-3 Receptor Antagonists
Triptans
Varenicline (Chantix)
Revised 10.12
Revised 10.12
Revised 10.12
Revised 10.12
Revised 10.12
Revised 10.12
Revised 10.12
Revised 10.12
Inquiries
Ohio Regional Formulary Management/Drug Information Service
(8:30 a.m. — 5:00 p.m. Mon — Fri, excluding holidays)
E-mail: [email protected]
Pager for urgent inquiry: (216) 568-3133
References are available upon request