The purpose of the PBM-MAP-VPE Ez-Minutes Newsletter is to communicate with the field on items that will impact clinical practice in the VA……whether it be changes to the National Formulary, availability of new Criteria for Use, or recent medication safety issues. We want clinicians to be informed and be the first to know about all updates and changes because it will impact the end users….i.e., the Veterans that we have the privilege of serving. Speaking of changes….you may have noticed with the previous issue, that you never received an automatic notice informing you that the Ez-minutes Newsletter was now available. Subscribing to the PBM-MAP-VPE Ez-Minutes and the electronic notification will no longer be offered. We believe our 15K+ “followers” of Ez-Minutes is sufficient to keep the lines open between the field and the PBM-MAP-VPE Committee. The Ez-Minutes Newsletter will continue to be posted on the PBM Internet and Intranet websites. Notification of the availability of Ez-Minutes Newsletter will be done electronically via multiple internal list serves also. Of course, we are depending on you to continue to spread the word, forward the newsletter to your colleagues, P&T committee members, and CMOs etc. Each issue will include the date when the next issue will be released so, you will know in advance when to expect the next issue of Ez-Minutes.

Editor's Note: This 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 continue, we welcome any feedback and comments. Send comments directly to Janet.Dailey@va.gov with Ez-Minutes in the subject line.

INSIDE THIS ISSUE

·       National PBM Documents Posted: Nov 11-Jan 12)

·       VAMedSAFE Documents posted: Nov 11-Jan 12

·       Anticoagulation in Women Veterans

·       Effect of Concomitant Use of Clopidogrel and PPI after PCI….again??

·       Fingolimod CFU Changes

·       Ask PBM Clinical Email

·       Pharmacy-Prosthetics-Logistics Acquisitions [PPLA] Workgroup Recommendations

·       PBM Educational Programs

·       VHA and FDA’s Drug safety Oversight Board Recent Decisions

VAMedSAFE Documents Posted: November, 2011 – January, 2012

National PBM Bulletins

National PBM Communication

·         Aliskiren Adverse Events in Combination with an Angiotensin-Converting Enzyme Inhibitor or Angiotensin II Receptor Antagonist in Patients with Type 2 Diabetes Mellitus [Jan. 2012-pending posting]

·         Dronedarone (MULTAQ) and Increased Risk of Death and Serious Cardiovascular Events in Patients with Permanent Atrial Fibrillation [Jan. 2012- pending posting)

·         Lexiscan® (Regadenoson) Update: New Safety Labeling Changes Approved By FDA [Jan. 2012]

Anticoagulation in Women Veterans of Reproductive Age

VA MedSAFE has identified women Veterans of childbearing potential who have been prescribed warfarin and may require additional counseling or referrals.  (See VA PBM’s guidance document: Anticoagulation, Special Considerations for Women of Reproductive Age

Warfarin poses unique concerns for women of childbearing age.  As an anticoagulant, it can exacerbate menstrual problems (e.g., heavy bleeding) and increase risk should an ovarian cyst rupture.  Unless women are provided with guidance on how to control menses, they may engage in dangerous self-management efforts (e.g. decreasing their warfarin dose).  As an FDA class X medication, warfarin requires women carefully plan for pregnancy, using effective contraception until they are ready to transition to low molecular weight heparin with pregnancy.  In an effort to prevent medication-induced birth defects, VA Women’s Health Strategic Healthcare Group and VA Pharmacy Benefits Management (PBM) Services aim to improve awareness of these issues and increase documented use of contraception by women Veterans prescribed warfarin. 

Action:  Please ensure that the women Veterans you follow on warfarin are assessed for menstrual difficulties, medication adherence, and chance of unintended pregnancy, and that referrals to local Primary Care or Women’s Health are provided as needed.  No feedback to VA MedSAFE is required at this time. 

Effect of Concomitant Use of Clopidogrel and Proton Pump Inhibitors After Percutaneous Coronary Intervention

Banerjee S, Weideman RA, Weideman MW, et al. Am J Cardiol. 2011;107:871-878.

Still wondering whether combined use of clopidogrel and proton pump inhibitors (PPIs) impairs the intended antiplatelet activity of clopidogrel?

Data from the Veterans Affairs Pharmacy Benefits Management database was analyzed in post-discharge exposure on the outcomes of 23,200 patients who received uncomplicated cardiac stent placement using daily reconciliation of medication exposures for each patient. Omeprazole was the most commonly prescribed PPI (88%); esomeprazole, lansoprazole, rabeprazole, and pantoprazole accounted for the remainder of PPI prescriptions.

Key Study Points

·         Continuous exposure to clopidogrel with concomitant use of PPIs in patients after percutaneous coronary intervention was not associated with increased risk for major adverse cardiovascular events, the primary endpoint of the study.

·         The hazard ratios of adverse cardiovascular outcomes overall replicated the concerns of increased risks associated with concomitant exposure to clopidogrel and a PPI. However, after the investigators used propensity-matched evaluations to correct for covariate cardiovascular risks, no significant association between major cardiovascular events and use of clopidogrel with continuous, switched, or discontinued PPIs was found.

·         This study also illustrates the importance of careful analysis of drug-prescription patterns before conclusive recommendations previously reported from retrospective analyses.

Be sure to read PBM-MAP-VPE Clinical Recommendations about Clopidogrel and Pharmacogenomic Testing

Changes to Fingolimod CFU

The FDA and European Union (EU) are currently reviewing all reports of death associated with fingolimod during clinical trials and post marketing reports. In November 2011, a patient death was reported 24 hours after the initial dose of fingolimod was administered. At this time, there are no other details available about this case other than the concurrent medications being amlodipine and metoprolol. The summary provided by Novartis describes 11 deaths which could be related to cardiac causes; 3 listed as complications of MS, 3 MI, 2 drowning, 2 unexplained that occurred during sleep and 1 hypertensive cardiovascular disease.  Additionally, there is a published case report of a patient developing a 7 second period of asystole 21 hours after fingolimod initiation. As a result of the recent findings, there is concern regarding the level of monitoring during the 6 hr post dose period, patient groups who may be at increased risk and the need to use telemetry. The EU has issued new guidance regarding the monitoring parameters to be used with fingolimod. The FDA has not issued final guidance on any changes to the product labeling.  See Fingolimod CFU

Submitted by Kathryn Tortorice Pharm D, BCPS                                                                                                                                                      

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 will not receive a response.

Pharmacy-Prosthetics-Logistics and Acquisitions (PPLA)* Workgroup Recommendations

The table below depicts the various products reviewed during December meeting. The X marks which service(s) the workgroup recommended is responsible for managing the respective products.  For a list of previous workgroup recommendations, please click HERE,

Implementation of these recommendations should be coordinated between services at local sites to ensure a smooth transition if recommendations lead to a change in responsible service. If you have any questions related to this announcement, please contact the responsible local service (Pharmacy, Prosthetics, or Logistics) for more detailed information.

*The Pharmacy, Prosthetics, Logistics (PPL) workgroup was created to help clarify the responsibility for management (e.g. ordering, storing, purchasing, AND/OR 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.

Give Those Bones a Break: Understanding the Algorithms and Criteria for Use (CFU) for Osteoporosis

February 21 at 3 PM EST.

Todd Semla, PharmD, BCPS, FCCP, AGSF Clinical Pharmacy Specialist, National PBM Services

Dial In Number: 1 -800-767-1750 Access 49792#.

Join the meeting

All PBM-MAP-VPE Webinars are held monthly on the third Tues at 3 PM EST. Tentative Future Program Schedule

Click HERE to view other Accredited PBM-MAP-VPE Educational Programs on anticoagulant bleeding, Pharmacy Technician Training Modules, and Treating Osteoporosis in male Veterans. Click here HERE to view archived PBM-MAP-VPE Programs on Hepatitis C Therapy, dabigatran, and more. (Please note, these programs do not offer accreditation)

All PBM-MAP-VPE Live Meeting programs are posted on CDN/TMS with no accreditation.

FYI: PBM Educational Programs are being transitioned over to a new site: https://vaww.portal.va.gov/sites/ed/default.aspx. Bookmark this link to your favorite!

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