Download January 2012 - Kaiser Permanente

Ohio Region
Drug Therapy
ADVISORY
New Kaiser Permanente of Ohio
Facilities Now Open
(Paul Bandfield, PharmD and Andrea Nixon, PharmD, Formulary Management
Services)
 New Kaiser Permanente medical office locations have opened
in Mentor, Medina, Kent, Concord and North Canton
 The new facilities will provide primary care, laboratory and
pharmacy services
 These new facilities expand access to Kaiser Permanente’s
integrated care model for our members
 All new pharmacy facilities are open Monday through Friday
9:00 AM through 7:00 PM and are closed Saturday, Sunday and
holidays
 For a listing of all pharmacy phone and fax contact
information, search for “Pharmacy Locations” in the Ohio
Lexicomp database
 The new facility locations are:
Concord Medical Office
Gristmill Village, 7536 Fredle Drive, Concord, Ohio 44077
Kent Medical Office
2500 State Route 59, Suite 28, Kent, Ohio 44240
Medina Medical Office
3443 Medina Road, Suite 108, Medina, Ohio 44256
Mentor Medical Office
7695 Mentor Avenue, Mentor, Ohio 44256
North Canton Medical Office
4914 Portage Road, North Canton, Ohio 44720
Humulin R U-500 Insulin Dosing
(Ashley Mullins, PharmD Candidate 2012, University of Toledo and Alynn
Anzevino, PharmD, Formulary Management Services)
 Humulin R U-500 (500units/mL) is 5 times more concentrated
than Humulin R U-100 (100units/mL)
 Humulin R U-500 is for subcutaneous injection only
 Humulin R U-500 is a clear, colorless regular insulin that
cannot be mixed with other insulin
 Humulin R U-500 may be useful for patients with severe insulin
resistance requiring greater than 200units of insulin per day
 Humulin R U-500 is a high alert medication according to the
Institute for Safe Medication Practices (ISMP)
 Unintentional overdose of insulin is responsible for 14% of
adverse drug event emergency hospitalizations
 Humulin R U-500 is of particular safety concern due to its
increased potency
 ISMP released safety report in January 1997, weeks after
medicine was approved by the FDA
o No U-500 syringe available
o Options: Tuberculin syringe or U-100 syringe
Issue 1
January 2012
Network Edition
o Recommendation from ISMP & FDA: write dose as units
along with corresponding markings on the syringe the
patient is using
 U-100 syringe example: 50 units (10 units)
 Tuberculin syringe example: 50 units (0.1 mL)
 Package insert contains a conversion chart between U-500
insulin and U-100 syringes
Humulin R U-500 dose
U-100 insulin syringe
(units)
(unit markings)
100
20
200
40
300
60
400
80
500
100
Dose (actual Humulin R
Divide dose (actual Humulin
U-500 units)
R U-500 units) by 5
Counseling points with patients:
 U-500 insulin is 5 times as concentrated as the U-100 insulin
 Differences between how many units of U-500 they are taking
and how it will measure on a U-100 syringe
 Have patient write down their Humulin R U-500 exact dose in
units on a medication card and keep it in their wallet or purse to
help with future health visits
 Show the patient how to measure their insulin with the U-100
syringe, reminding them exactly how many units they are really
getting while using the U-500 insulin with this syringe
FDA Alerts
Dabigatran (Pradaxa): Reports of
Serious Bleeding
(Andrea Nixon, PharmD, Formulary Management Services)
 The U.S. Food and Drug Administration (FDA) is evaluating
post-marketing reports of serious bleeding events in patients
taking the anticoagulant dabigatran (Pradaxa) submitted to the
Adverse Events Reporting System (AERS) database
 The events are being analyzed to determine whether the
reports of bleeding in patients taking Pradaxa are occurring
more commonly than would be expected, based on observations
in the large clinical trial that supported the approval of Pradaxa
 FDA is analyzing the post-market reports for evidence of
inappropriate dosing, use of interacting drugs, or other clinical
factors that might lead to a bleeding event
 At this time, FDA believes the benefits of Pradaxa continue to
exceed the potential risks when the drug is used appropriately
following the approved drug label
 More information can be found at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAler
tsforHumanMedicalProducts/ucm282820.htm
(Continues on the reverse side)
Issue 1 — Network Edition
(Continued from previous side)
Liquid Acetaminophen Marketed for
Infants: Potential for Dosing Errors
(Paul Bandfield, PharmD, Formulary Management Services)
 An additional concentration of liquid acetaminophen marketed
for infants (160mg/5mL) is now available
 The concentration change will affect the amount of liquid given
to an infant
 This should be especially noted if someone is familiar to using
the 80mg/0.8mL or 80mg/mL concentrations of liquid
acetaminophen
 In addition to the concentration change, the new product
should be packaged with an oral syringe instead of a dropper
Recommendations:
 Carefully read the Drug Facts label on the package to identify
the concentration of the liquid acetaminophen dosage and
directions for use
 Use the dosing device provided with the product in order to
correctly measure the amount of liquid acetaminophen to be
given
 Always provide directions to patients that specify the
concentration and dose of liquid acetaminophen that should be
given to a child
 More information can be found at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAler
tsforHumanMedicalProducts/ucm284807.htm
Dronedarone: Increased Risk of Death
(Jessica Gentile, PharmD Candidate 2012, Ohio Northern University and Paul
Bandfield, PharmD, Formulary Management Services)
• In December 2011, the FDA completed a safety review of
dronedarone (Multaq) use in patients with permanent atrial
fibrillation (AF)
o Reported a two-fold increase in serious cardiovascular
events, including death, stroke and heart failure
• FDA released revised labeling regarding Multaq use to include:
o Healthcare professionals should NOT prescribe Multaq to
patients with permanent AF
o Cardiac rhythm monitoring with electrocardiogram (ECG)
should be conducted at least once every three months
o Patients prescribed Multaq should receive appropriate antithrombotic therapy
• At present, Multaq is indicated for reduction in hospitalization
for AF in patients with paroxysmal or persistent AF, who are
currently in sinus rhythm
• FDA will be further evaluating the risk evaluation and
mitigation strategy (REMS) program for Multaq
• More information can be found at:
http://www.fda.gov/Drugs/DrugSafety/ucm283933.htm
Other FDA Alerts
CardioGen-82 PET Scan: Drug Safety Communication Increased Radiation Exposure
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAler
tsforHumanMedicalProducts/ucm263157.htm
Endo Pharmaceuticals Opiate Products by Novartis Consumer
Health: Public Health Advisory - Potential Safety Risk
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAler
tsforHumanMedicalProducts/ucm286280.htm
Novartis Consumer Health Over-The-Counter Products: Recall
- Potential Presence of Foreign Tablets or Chipped or Broken
Tablets or Gelcaps
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAler
tsforHumanMedicalProducts/ucm286265.htm
January 2012
Gilenya (fingolimod): Drug Safety Communication - Safety
Review of a Reported Death After the First Dose
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAler
tsforHumanMedicalProducts/ucm284355.htm
Zocor (simvastatin): Label Change - New Restrictions,
Contraindications, and Dose Limitations
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAler
tsforHumanMedicalProducts/ucm258384.htm
Selective Serotonin Reuptake Inhibitor (SSRI)
Antidepressants: Drug Safety Communication - Use During
Pregnancy and Potential Risk of Persistent Pulmonary
Hypertension of the Newborn
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAler
tsforHumanMedicalProducts/ucm283696.htm
Initiatives
Inter-Regional Clinical Pharmacy Services
Subcommittee (ICPSS) Initiatives
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Insulin NPH and 70/30 use preferred over Lantus and Levemir
Lovenox use preferred over Arixtra
Abilify half-tab initiative
Dulera use preferred over Advair and Symbicort
Generic venlafaxine ER capsule use preferred over brand
Effexor XR capsule and venlafaxine ER tablet
Brand Adderall XR capsule preferred ADHD medication
OxyContin use discouraged over other long-acting opioids
Skeletal muscle relaxant use discouraged in elderly
Hydroxyzine use discouraged in elderly
Pharmacy Conversion Team Projects
 Androderm Therapeutic Interchange
Current Half-Tab Initiatives
Abilify
Brand Aricept
Brand Celexa
Crestor
Brand Imitrex
Brand Lamictal
Levitra
Lipitor
Nuvigil
Brand Paxil
Provigil
Viagra
Brand Zocor
Brand Zoloft
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 through the Internet
(online.lexi.com/login using login and password: ohkprx)
Formulary changes are updated in Lexicomp on their respective
effective dates.
Criteria Updates
Angiotensin II Receptor Blockers (ARB)
Omega-3-Acid Ethyl Esters (Lovaza)
Pentosan Polysulfate Sodium (Elmiron)
Revised 01.12
Revised 01.12
Revised 01.12
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.