PBM-MAP-VPE Ez-Minutes Newsletter is an on-line quarterly newsletter. In order for the newsletter to automatically be delivered to your InBox, you need to subscribe to it. The purpose of the PBM-MAP-VPE E_z-Minutes is to communicate with the field on items that will impact clinical practice in the VHA...whether it be changes to the National Formulary, new Criteria for Use or medication safety issues. We want clinicians to be informed. For NEW subscribers only; click on stxcollage@va.gov with "PBM subscribe" in the subject line to subscribe to the newsletter. For “old” subscribers, (but young at heart), please forward this newsletter to your staff, fellow colleagues, and P&T committee members etc. so they may take this opportunity to subscribe.

Editor's Note: The newsletter is in a HTML format. A printer-friendly document throughout the system is more likely to occur with a HTML format compared to a Word document. Users should select print preview and review the document, then make any necessary changes to the document before printing to ensure the document will print fine for their hardware configuration.  As further updates to the newsletter and websites continue, we welcome any feedback and comments. Send comments to Janet.Dailey@va.gov with E_z-Minutes in the subject line.

INSIDE THIS ISSUE

·  Posting of National PBM Documents (Aug-Oct. 2010)

·  Posting of VAMedSAFE Documents (Aug-Oct. 2010)

·  Serious Medication Errors from IV  Administration of Nimodipine PO Capsules

·  VAMedSAFE Pilot Study: Currently Recruiting Sites

·  PPSPD Workgroup Recommendations

·  Heparin and Change in USP Monograph

·  VA Advanced Provision of Levonorgestrel Emergency Contraception

·  CEUs: PBM-MAP-VPE Educational Programs

·  ASK PBM Clinical Email

·  Questions/Answers and Useful Links

·  VHA and DSB: Drug Safety Oversight Board (DSB): Recent Board Topics

·  Publications by VA Pharmacists

VAMedSAFE Documents Posted August-October 2010

National PBM Communications:

·                     Epoetin Alfa (Epogen® and Procrit®) Voluntary Recall [September, 2010]

·                     Regadenoson (Lexiscan®) and Updated Labeling Changes [September, 2010]

Please Note: On the Bulletins and News Alerts section of the VAMedSAFE website, click on the heading of the first column (Safety Issue) to sort Bulletins/Communications alphabetically according to drug or safety issue.  Click on the heading of the second column (Date) to sort chronologically. 

FDA Drug Safety Communication: Serious Medication Errors from IV Administration of Nimodipine Oral Capsules

Editor’s Note: This article was abbreviated due to space limitations. Please Click Here to read the full content.

Information for Healthcare Professionals (per the FDA Drug Safety Communication)

·         Be aware that nimodipine capsules should be administered ONLY by the oral route or via nasogastric tube. It should NEVER be administered intravenously.

·         If the nimodipine capsule cannot be swallowed, e..g., at the time of surgery, or if the patient is unconscious, a hole should be made in both ends of the capsule with an 18 gauge needle, and the contents of the capsule extracted into a syringe. To help minimize administration errors, it is recommended that the syringe be labeled "Not for IV Use." The needle should be removed from the syringe and the contents should then be emptied into the patient's in situ nasogastric tube and washed down the tube with 30 mL of normal saline (0.9%).

·         Report adverse events or medication errors involving nimodipine capsules to the FDA MedWatch program.

According to the VA National Center for Patient Safety (VA NCPS), there have been no reports of medication errors related to the IV administration of nimodipine.  In addition, there have been no reports of adverse events with nimodipine in the VA Adverse Drug Event Reporting System (VA ADERS).  If an adverse event or medication error occurs with nimodipine, these should be reported to VA ADERS or VA NCPS per local VA protocols.

See the following link for the full content of the FDA Drug Safety Communication on Nimodipine from Aug. 2, 2010:  http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm220386.htm#sa

Submitted by Elaine Furmaga, PharmD

 VAMedSAFE Supported Research Feasibility Study

Interested in participating in a feasibility study as a Site Investigator or Provider, including an optional resident component? VAMedSafe is currently recruiting sites for a pilot cluster-randomized trial of chlorthalidone and HCTZ. The goal of the study is to assess the feasibility of the study design for comparative effectiveness trials embedded in usual care. Click Here to read more details. If interested, please contact Madeline.McCarren@va.gov  or call 708-786-7987.

Pharmacy-Prosthetics-SPD (PPSPD) Workgroup Recommendations

The Pharmacy, Prosthetics, SPD workgroup was created to help clarify the responsibility for management (e.g ordering, storing, purchasing, and dispensing) of those products in which it is not clear which service should provide. The workgroup is not responsible for determining formulary status, clinical merit or appropriate use of the products reviewed. The table below depicts the various products reviewed at the Aug. and Sept 2010 meetings. The X marks which service(s) is responsible for managing the respective products. Please refer to CLICK HERE  for further details and explanation of the decision process including decisions made from earlier meetings.

Heparin and Change in USP Monograph

Editor’s Note: This article was abbreviated due to space limitations. Please CLICK HERE to read more information including additional links to helpful resources such as the FDA Communication update [April, 2010] and the VA National PBM Communication [April, 2010].

VA Pharmacy Benefits Management Services (PBM) and VA Center for Medication Safety (VA MedSAFE) are performing ongoing monitoring of adverse drug events (ADEs) associated with heparin in VA reported via the VA Adverse Drug Event Reporting System (VA ADERS) that could potentially be related to the reduced potency of the “new” heparin products (e.g., therapeutic failure, new thromboembolic event, etc.).  To date, reports do not indicate a significant increase in ADEs associated with “new” heparin products.  If an ADE is suspected, remember to report the event according to usual local procedure in the Computerized Patient Record System (CPRS) and subsequently submit the report into VA ADERS by local procedure.  If possible, also note in the report whether the “new” or “old” heparin product was used.

Advanced Provision of Levonorgestrel Emergency Contraception (EC) (Plan B™) in VA

Editor’s Note: This article was abbreviated due to space limitations. Please CLICK HERE to read the article in its entirety. Be sure to review the PBM Monograph for additional information.

Levonorgestrel EC tablets are on the VA National Formulary without additional national restrictions, and processes should already be in place at VA Medical Centers to insure that women veterans have timely access (e.g., same day/visit) to levonorgestrel EC without barriers.  The drug is most effective the sooner it is taken after an episode of unprotected intercourse, generally up to 72 hours, though some effectiveness is maintained for up to 120 hours.  In addition to requests for immediate use, VA providers are also requesting that levonorgestrel EC be provided to certain women veterans before it is needed, also known as “advanced provision.”

The PBM-MAP-VPEs recommend the following:  1) The topic of EC should be included in contraception discussions between patient and provider at regular visits; 2) For immediate use, levonorgestrel should be made readily available to women veterans who request it for up to 120 hours after unprotected intercourse; and 3) An advanced supply of levonorgestrel EC may be provided to women veterans when requested by provider or patient.

Submitted by Lisa Longo, PharmD, BCBS

Accredited PBM-MAP-VPE Educational Programs

* Per Field Request:  Posted on the PBM website (under Distance Learning Broadcast and other Educational Opportunities tab) are screen shots for each respective program. To date, since these programs can only be taken once, the content is being provided to the field to modify or use for future use if needed. An update on whether these programs will be “reset” will be posted later. However, if LMS/EES elects to reset the programs, NO accreditation will be provided. Please note the determination of participants for which programs to view if used is by the discretion of local facility and/or VISNs. These programs are not mandatory. In the past, facilities have assigned these as mandatory programs for all staff.  Medical Centers should also consider using the results of anticoagulation quality assurance and performance improvement activities in determining educational needs to improve staff competence. Contact Janet Dailey Janet.Dailey@va.gov with any questions or additional information.

Click HERE and open the Distance Learning Broadcast folder for more program details including the

Women’s Health Teleconferences

ASK PBM Clinical E-Mail

If you’ve been eager to know the status of a new drug as it moves through the formulary approval process or have a question about criteria for use etc., drop us an e-mail at VHAPBH Ask PBM Clinical (AskPBMClinical@va.gov).  Please note this address should only be used by VA employees; requests from e-mail addresses outside the VA may not receive a response.

Questions/Answers and Useful Links:

VHA Handbook 1108.08, VHA Formulary Management Process: Great resource that answers many of the field questions asked such as:

Can VISNs alter National Criteria for Use documents? (see pg 11)

Where can I find the guidance for compassionate use of Nutriceuticals? (see pg. 14)

Is there a policy for dispensing non formulary meds to a patient transferring from one VA to another? (see pg. 15)

Where are the PBM criteria for drugs which are considered cosmetic? (see pg. 17)

VA Foreign Medical Program: Provides guidance to providing medications to veterans living in foreign countries

National PBM status of reviews: Learn the status of reviews being conducted at the National PBM

Guidance for off-label prescribing:

http://www.healthquality.va.gov/: This is the OQP website which includes VA/DOD Clinical Practice Guidelines such as Management of Opioid Therapy for Chronic Pain  and the Management of Diabetes Mellitus ---BOTH NEW!

http://vaww.national.cmop.va.gov/PBM/Lists/Pharmacy%20Phone%20Directory/General.aspx: List of Direct VA Pharmacy Numbers

http://vaww.national.cmop.va.gov/FDAMedicationGuideTestSite/FDAMedicationGuides/Forms/AllItems.aspx: List of medications the VA pharmacy dispenses with a medication guide.

Clinical Considerations Regarding Veteran Patients who Participate in Sate Medical Marijuana Programs

The Veteran’s Health Administration (VHA) and FDA’s Drug Safety Oversight Board

The FDA Drug Safety Oversight Board (DSB) discussed two topics at its July 2010 meeting and three topics at its September 2010 meeting. A link to the Public Summary of each meeting is included.  DSB members representing the VHA include Drs. C. Bernie Good (VA Pittsburgh Healthcare System), Peter Glassman (VA Greater Los Angeles Healthcare System), and Walid F. Gellad (VA Pittsburgh Healthcare System).

The Board also discusses recently released and proposed Drug Safety Communications at each of its meetings. FDA Drug Safety Communications can be accessed through the following webpage:

http://www.fda.gov/Drugs/DrugSafety/ucm199082.htm

Update on Recent Board Topics:

July 2010: Proton pump inhibitors and the risk of fractures; A path forward update for the Drug Safety Oversight Board http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm221994.htm

September 2010: Update on Risk Evaluation and Mitigation Strategies (REMS); Stalevo and cardiovascular safety; Update on the Safe Use Initiative http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm082136.htm

Editor’s Note: As mentioned previously, a new feature to the newsletter will be including recent updates discussed by the DSB.

We hope that it will provide greater awareness among VA healthcare professionals about the DSB. If you have any feedback to the DSB, please contact Steven Osborne, MD, Executive Director of the Drug Safety Oversight Board.

Publications by VA Pharmacists (← CLICK ON THE LINK)

Hey VA Pharmacists: The site is growing. Be sure to click on to the link to see what your colleagues are researching and reporting. The PBM again would like to remind VA pharmacists to send your published articles/studies starting from 2009 on. Don’t be shy….send them to Janet.Dailey@va.gov for posting.