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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.
NEW! Subscribe to PBM-MAP-VPE Ez-Minutes RSS (Really Simple Syndication) Feed on any computer with an RSS-compatible program installed, 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
Editor's Note: You will note a few new features in this issue of Ez-Minutes. First, hyperlinks have been added to the posted documents below so it will be one click shopping and EZ to locate the documents! Thank you Dr. DeBoer-Billings CBOC for your suggestion. Also, on the Ez Minutes web site a RSS (Really Simple Syndication) subscription link has been added. After selecting the RSS Feeds, a link at the bottom of the page called Subscribe to an RSS feed will provide instructions on how to subscribe to an RSS feed depending on what software you want to use for the subscription. Some of you may be asking, “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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INSIDE THIS ISSUE · National PBM Documents Posted: May-July 2012 · Updated Performance Measure for Lipid Control · Seasonale (and Equivalents) Extended Cycle Oral Contraceptive Added to VANF · Pharmacy-Prosthetics-Logistics and Acquisitions (PPLA) Workgroup Recommendations · Veteran’s Health Administration (VHA) and FDA Drug Safety Oversight Board (DSB)
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VA ADERS is the VA’s National Adverse Drug Event (ADE) Reporting System. All observed ADEs should be reported to VA ADERS to aid in VA’s medication safety activities. VA Clinical Staff with access to read progress notes in CPRS may log into VA ADERS at this site: https://medora.va.gov/vaaders/medsafe_portal/index.asp select VA ADERS Launch and use your CPRS/VistA Access and Verify codes to login. - VA ADERS Summary (Canned) Reports are up to date through June 2012 and available by logging into VA ADERS and selecting Canned Reports (local pharmacy chief approval for access is required for viewing Summary Reports). Updated Performance Measure for Lipid Control
A previous issue of the PBM-MAP-VPE EzMinutes May-July 2011 “first broke” this story. The new performance measure for lipid control has come to fruition. Background: Recent analyses of cardiovascular prevention studies have raised concerns about performance measures for lipid management based solely on achieving target values of LDL-C. It is recognized that the use of statin drugs can provide significant benefit in patients with diabetes or ischemic heart disease even if the LDL-C values remain above 100 mg/dL. A successful lipid management intervention should be based on the appropriateness of the therapy and NOT solely on the value of the LDL-C. In response to the evidence, VA’s Performance Measurement System and External Peer Review Program are implementing a revised approach to lipid management beginning with fiscal year 2012. In the interim, the clinical reminders for lipid control based solely on LDL-C <100 mg/dL are to be discontinued. It should be noted that performance measures are NOT intended to substitute for clinical judgment and patient-centered care.
For Veterans with Diabetes or Ischemic Heart Disease, lipid control will be deemed appropriate if either of the following criteria are met: 1) The patient is receiving at least a moderate dose of a statin drug, as defined as : · atorvastatin ≥ 10 mg/day; fluvastatin ≥80 mg/day; lovastatin ≥ 40 mg/day; pravastatin ≥ 40 mg/day; rosuvastatin ≥5 mg/day; simvastatin ≥20 mg/day OR 2) LDL-cholesterol (LDL-C) value is 100 or less
The Updated Performance Measure for Lipid Control will be the topic for the next PBM Webinar scheduled for September 18th, 2012 at 3 PM EST. (see below for Live Meeting link). Representatives from cardiology, endocrinology, and primary care will be the faculty. Make sure you save the date on your calendar. You won’t want to miss it.
References: ACCF/AHA/AMA–PCPI. 2011 Performance Measures for Adults With Coronary Artery Disease and Hypertension A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Performance Measures and the American Medical Association–Physician Consortium for Performance Improvement. Circulation. 2011, 124:248-270. Hayward RA, Krumholz HM. Three Reasons to Abandon Low-Density Lipoprotein Targets: An Open Letter to the Adult Treatment Panel IV of the National Institutes of Health. Circulation: Cardiovasc Qual Outcomes 2012;5;2-5. Seasonale (and Equivalents) Extended Cycle Oral Contraceptive Added to VANF
In comparison to traditional oral contraceptive pill regimens that provide 21 days of active pills followed by 7 days of placebo pills, extended cycle products provide longer durations of active pill days (e.g., 84 active pill days followed by 7 placebo days). Extended cycle oral contraceptives reduce the frequency of withdrawal bleeding or suppress menses completely and offer women increased convenience, health benefits, and potentially cost savings. In addition to the medical benefits that all oral contraceptives provide such as relief from dysmenorrhea, menorrhagia, menstrual migraine, etc., extended cycle regimens offer women less frequent menstruation. Several extended cycle oral contraceptive products are available differing in regimen and amount of estrogen and progestin. Off-label use of traditional cycle products includes “stacking” the 21 active /7 placebo day packs of pills for 4 packs, skipping the placebo pills in the first 3 packs thus providing 84 active pill days and 7 placebo pills. Patients need to be instructed on how to take pills, including discarding the placebo pills depending on the type of regimen. Pharmacies and providers need to adjust the days’ supply when ordering products to be stacked (e.g., 4 packs of pills needed for a 90 day supply when the placebo pills are skipped). Seasonale and equivalent products (30 mcg EE and 0.15 mg levonorgestrel x84 active pills followed by 7 placebo pills) were recently added to VA National Formulary, offering women Veterans a convenient and cost-effective alternative for contraception. If a lower dose of estrogen (e.g., 20 mcg) is desired by patient or provider, patients should be offered either 1) a VANF option of a stackable low-dose estrogen regimen of the traditional 21 active/7 placebo Alesse and equivalent products (20 mcg EE/0.1 mg levonorgestrel) for 4 packs, skipping placebo pills for the first 3 packs; or 2) a nonformulary lower dose extended cycle product (e.g., Lo Seasonique and equivalents) based on clinical need. The Lo-Seasonique and equivalent products provide 7 days of low dose estrogen only pills instead of placebo pills at the end of the pack. CLICK HERE to view lowest cost equivalents as of June 2012 for extended cycle oral contraceptive regimens. Note the VA costs may vary and should be periodically reviewed at the facility level.
Submitted by Lisa Longo, PharmD, BCPS Editor’s Note: This article was condensed due to space constraint. Please CLICK HERE to read the complete article. Upcoming PBM Educational Programs
Taped PBM-MAP-VPE Programs with No Accreditation during May-July 2012
All PBM-MAP-VPE Live Meeting programs are posted on CDN/TMS with no accreditation. Links to taped programs can also be found here: https://vaww.portal.va.gov/sites/ed/FormServerTemplates/Webinars.aspx Pharmacy-Prosthetics-Logistics and Acquisitions (PPLA) Workgroup Recommendations The table below depicts the various products reviewed during May 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
For certain products, VISN or local Clinical Product Review Committee (CPRC) must review and approve prior to providing.
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. Veteran’s Health Administration (VHA) and FDA Drug Safety Oversight Board (DSB) The FDA Drug Safety Oversight Board (DSB) met in May, June, and July 2012. Topics discussed were: FDA Approved Label and Public Payer Coverage Decisions; Patient – Prescriber Agreements; Sterility Requirements for Antiseptic Preoperative Skin Preparations; Commercial Websites and Safety Information, and Clozapine Registries. The DSB also took part in a focus group this past January on Risk Communication and the results of that research were discussed at the July meeting.
The link to the DSB Public Summaries: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm082136.htm?
The Board discussed 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
DSB members representing the VHA include Drs. C. Bernie Good and Walid F. Gellad (VA Pittsburgh Healthcare System) and Dr. Peter Glassman (VA Greater Los Angeles Healthcare System).
Editor’s Note: If you have any feedback to the DSB, please contact Georgianna Ienzi Georgiann.lenzi@fda.hhs.gov., DSB Project Manager
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