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Purpose of the PBM-MAP-VPE Ez-Minutes Newsletter: To communicate with the field on items that will impact clinical practice in the VA….whether it is changes to the National Formulary, availability of new Criteria for Use, or recent medication safety issues. We want clinicians to be informed! Subscribe using RRS (Really Simple Syndication) Feed: Any computer with a RSS-compatible program installed will work such as Microsoft Outlook 2007 or later. To view and subscribe to this RSS Feed, copy and paste the following web address into your web browser: http://www.pbm.va.gov/rss/EzMinutesRSS.xml. After selecting the RSS Feed, a link at the bottom of the page called Subscribe to a RSS feed will provide instructions on how to subscribe to a RSS feed depending on what software you want to use for the subscription. Question: “What does a RSS feed do?” Answer: When new content is posted, in this case, the new issue of Ez-Minutes, it will alert the user BUT….it isn’t until the user clicks on the RSS feed notification will it download the content. We are testing it first with Ez-Minutes before adding the feature to other areas so we welcome any feedback and comments. Send comments directly to Janet.Dailey@va.gov with Ez-Minutes in the subject line. |
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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. Feedback and comments are welcomed. Send comments to Janet.Dailey@va.gov with Ez-Minutes in the subject line. |
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National PBM Bulletins |
National PBM Communication |
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· Ondansetron 32mg Single IV Dose Market Withdrawal Due to Cardiac Risks [Dec. 2012]
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· Zolpidem and Proposed Lower Doses Due to Impaired Mental Alertness, [Jan. 2013] · Dabigatran (Pradaxa®) and Packaging Error - Recall Due to Possible Compromise in Product Quality [Nov. 2012] · Ameridose Recall of All Unexpired Product Line [Nov. 2012] |
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DABIGATRAN ETEXILATE: MONITORING OUTCOMES, SAFETY, AND APPROPRIATE USE Dabigatran etexilate (Pradaxa), an anticoagulant used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, was FDA approved in Oct. 2010. In response to a high number of postmarketing reports of serious bleeding events with dabigatran following its approval, FDA launched a safety investigation. In Nov. 2012, results from the FDA Mini-Sentinel assessment were released and showed that bleeding rates with new users of dabigatran do not appear to be higher than bleeding rates with new users of warfarin.
Because of the potential widespread use of dabigatran in the VA population, the lack of long-term safety data, and limited information outside of a clinical trial setting, the VA Center for Medication Safety (VA MedSAFE) regularly monitors dabigatran for safety and inappropriate use through both active and passive surveillance. Outcome events undergo active surveillance assessments comparing new users of dabigatran to new users of warfarin with atrial fibrillation (AF) (Table 1). Monitored outcomes of interest include intracranial hemorrhage (ICH), gastrointestinal (GI) bleed, acute myocardial infarction (MI), and stroke. Thus far, rates for dabigatran adverse outcomes are relatively low, making it difficult to draw firm conclusions from the data. However, in concurrence with FDA Mini-Sentinel results, no safety signals have been identified for the outcomes studied to date (Table 2). The most common adverse events reported in the passive surveillance web-based VA Adverse Event for Reporting Systems (VA ADERS), with dabigatran as the primary suspect drug, are bleeding and GI symptoms. In addition to surveillance efforts, the dabigatran Medication Use Evaluation Tracker (MUET) is an intervention tool now available for pharmacists to evaluate potentially inappropriate (e.g., off-label use, incorrect dose) or unsafe (e.g., contraindication, severe renal impairment) use of dabigatran at the facility level. Monitoring will continue with reports provided every 6 months. |
VA MedSAFE Surveillance Summary through 9/30/2012:
Table I. Demographics
Table 2. Selected Outcomes of Interest -- Incidence per 1000 patient-years, (95% Confidence Interval [CI])
*Unadjusted hazard ratio (HR) for new DABI users vs. new WARF users = 0.99 (95% CI 0.78 – 1.25); adjusted HR = 1.1 (95% CI 0.85 – 1.37). Note: Confidence Intervals overlap between all groups for each outcome, indicating no significant differences between treatment groups and outcomes at this time. The number of outcome events with dabigatran is relatively small (new drug, limited patient exposure), resulting in wide confidence intervals for each outcome.
Submitted by Lisa Longo, Pharm.D., BCPS-VHA Pharmacy Benefits Management Services |
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PBM UPDATE: MANUFACTURER’S DISCONTINUATION OF BUPRENORPHINE/NALOXONE (SUBOXONE) SUBLINGUAL TABLETS Reckitt Benckiser Pharmaceuticals Inc. plans to voluntarily discontinue the distribution of buprenorphine / naloxone (SUBOXONE) 2 mg/0.5 mg and 8 mg/2 mg sublingual tablets on March 18th, 2013. Early education on the use of the film product may facilitate a smooth transition for patients when the time comes to switch from tablets to film. Early education about the film may be especially helpful for stable patients who may be seeing their provider only every 2 to 3 months for prescription renewals. PBM is recommending that VA pharmacies keep a 3-month supply of SUBOXONE tablets in stock to ensure an orderly transition to the film.
RECOMMENDATIONS FOR SUBOXONE prescribers: 1. Begin to educate your patients about the upcoming switch from tablets to film, particularly patients who are being seen on a less frequent basis. Explain to patients that the early education on the film is being provided to ease the transition from tablets to the film once the tablets are discontinued. 2. The film can be started at the same mg-per-mg dose as the tablets; however, individual patients may experience a different response on the film since some patients may have a slightly higher drug bioavailability with the film. Patients should be informed about this possibility and to call you or your clinic for possible dosage adjustment. 3. Refer to the SUBOXONE Medication Guide for patient instructions on administration and use of SUBOXONE film. Note that there are special instructions for opening the foil pouch; this is a safety feature intended to prevent young children from taking the medication. 4. Keep in contact with your facility’s Chief of Pharmacy to stay informed whether there is an ample supply of tablets in pharmacy to accommodate prescriptions, particularly those for more than one months’ supply of SUBOXONE tablets. Submitted by Francine Goodman, PharmD, BCPS-VHA Pharmacy Benefits Management Services VA POSTTRAUMATIC STRESS DISORDER (PTSD) CONSULTATION PROGRAM http://vaww.ptsd.va.gov/PTSD_Consultation_Program.asp The PTSD Consultation Program through the National Center for PTSD is available for VA providers to discuss any question having to do with PTSD (medication and prescribing questions, assessment and diagnosis, triage, clinical programming, etc.) within 24 hours of the request for consultation in a one-on-one telephone conversation. Consultation is free and can be with a psychiatrist or other mental health professional depending on the question. Questions can come from any VA provider from any discipline, not only PTSD specialists. This is a great resource for brainstorming about a tough case or getting consultation on a specific question. To request consultation, you can send an e-mail to ptsdconsult@va.gov or call 1-866-948-7880. More information about PTSD can be found at http://www.ptsd.va.gov/
PTSD Lecture Series PTSD Psychopharmacology Best Practices Lecture Series: The issues of polypharmacy and guideline-concordant prescribing remain a priority for VA in Veterans diagnosed with PTSD. This new lecture series will provide information on pharmacologic best practices in patients with PTSD and updates to recommendations in the PTSD Clinical Practice Guideline. With PTSD being one of the major disorders seen by VHA clinicians in Veteran patients, new information and recommendations must be communicated to all health care providers to keep up with the continuous updates to prescribing practices, practice guidelines, and pharmacologic best practices. The lectures are held on the 3rd Wednesday of every month at 2pm eastern and are followed by “office hours” by the guest speakers at 3pm.
The PTSD Consultation Program Lecture Series: Topics covered in this monthly lecture series emerge from clinical cases that have come into the PTSD Consultation Program with a lecture by an expert in a particular area. The lectures are held on the 3rd Tuesday of every month at 2:00pm eastern, are coordinated with EES and offer CEU’s and CME’s. They are also available on the VA TMS site for later viewing.
To receive notifications about the lecture series and links to sign up for specific talks, email casey.grysen@va.gov at EES. For more information about the PTSD Consultation Program, email sonya.norman@va.gov. Submitted by Sonya Norman, Ph.D. PTSD Consultation Program Director National Center for PTSD Pharmacy-Prosthetics-Logistics and Acquisitions (PPLA)* Workgroup The table below depicts the various products reviewed during November, 2012 meeting. The X marks which service(s) is responsible for managing the respective products. Please click HERE for further details and decisions made from earlier meetings.
+ Contingent upon approval from VISN or local Clinical Products Review Committee (CPRC)
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. For certain products, VISN or local Clinical Product Review Committee (CPRC) must review and approve prior to providing. If you have any questions related to this announcement, please contact the responsible local service (Pharmacy, Prosthetics, or Logistics) for more details information.
*The Pharmacy, Prosthetics, Logistics and Acquisitions (PPLA) 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. Teratogenic Medication Order Check: Creating a CPRS Tools Menu link to REPROTOX Read the Frequently Asked Questions (FAQ) Document for more information about the Teratogenic Medication Order Check. Instructions for a direct CPRS Tools menu link are posted HERE. NOTE: Some facilities will elect to place a hyperlink to REPROTOX directly on the CPRS Tools menu. Others will place the hyperlink on an existing website that is accessed from the Tools menu. Either approach is acceptable, and should be accompanied by staff education to inform providers of the availability of this new resource. Submitted by: Rob Silverman PharmD-PBM Clinical Informatics; Lisa Longo, PharmD, BCPS-VHA Pharmacy Benefits Management Services; Karen Feibus, MD VACO SAVE-THE-DATE PBM-MAP-VPE Webinars · February 19th, 2013 @ 3 PM ET: Update on Hepatitis C Treatment in VA . Join the meeting 1-800-767-1750 Access Code: 49792#. Accreditation ACPE, ACCME, ANCC, ACCME-NP (pending) · March 19th, 2013 @ 3 PM ET: STATS ALIVE! (2 part series)! Kick-Off for the Board Certification Study Groups and PBM Moodle Site: 1-800-767-1750 Access Code: 49792# Accreditation: ACPE (pending) Did you miss the Transforming VA Pain Care 2-part series on THE TALK: Opioid Trial and Exit Strategy? Click HERE on the PBM Education SharePoint site to listen to the taped series including all previous taped webinars. Taped webinars are also available via On-demand viewing in TMS: https://www.tms.va.gov/learning/user/login.jsp. Type “PBM” in the search field to retrieve PBM-MAP-VPE programs.
Future educational/training Program details are posted to the National PBM Education SharePoint site: https://vaww.portal.va.gov/sites/ed/default.aspx |
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