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The purpose of the PBM-MAP Ez-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 or new Criteria for Use. We want clinicians to be informed. We ask your assistance in forwarding this newsletter to health professionals on the front line, your staff, fellow colleagues, and VISN/local P&T committee members so they are kept informed of all the changes. Encourage them to take the opportunity to subscribe to the newsletter.….it’s FREE! For NEW subscribers only; click on stxcollage@va.gov with "PBM subscribe" in the subject line to subscribe to the newsletter.
Watch for the next PBM-MAP Ez-Minutes Newsletter (May –July 2010)….to be released August 5th, 2010.
The Pharmacy Benefits Management Services welcomes Thomas Emmendorfer, Pharm.D., as the new Assistant Chief Consultant.
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. We are interested in your feedback. Do you have any suggestions? Any topics you would like to read about that would be helpful? Send all comments/questions/suggestions, directly to Janet.Dailey@va.gov with Ez-Minutes in the subject line. Have a great summer! |
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· Posting of National PBM Documents (Feb - April 10) · Posting of VAMedSAFE Documents (Feb -April 10) · Ophthalmic MVI for Age-Related Macular Degeneration · VHA and FDA: Drug Safety Oversight Board (DSB) · Schedule II, III Narcotics and Alcohols Register Form o Can VA fill Rxs written by private prescribers? o What is a Medical Food? o How does FDA Oversee Medical Foods? |
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VAMedSAFE Documents Posted February - April 2010 |
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National Safety Bulletins |
National PBM Communications |
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· Clopidogrel and Omeprazole Drug Interaction (3/25/2010) · Natalizumab and the Risk for Developing PML and IRIS (3/09/2010) |
· Heparin and Potency Variation: UPDATE (4/07/2010) · LABA Safety in Asthmatic Patients (3/09/2010) |
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Please note: On the Bulletins and News Alerts section of the website (http://www.pbm.va.gov/VACenterForMedicationSafety-BulletinsAndNewsAlerts.aspx), 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. Medication Utilization Evaluation (MUE) Tracker VAMedSAFE developed the MUE Tracker (MUET) to facilitate the MUE process by serving 2 main functions: 1) identifying risk patients in need of a therapeutic intervention; 2) providing a centralized vehicle for recording and tracking these interventions in close to real-time. MUET is a secure web-based interactive data collection tool that can be accessed by VA clinicians within the VA healthcare system. On a monthly basis, each VA medical center is provided with lists of target risk patients that meet pre-set criteria for interventions. After entering pertinent information regarding a patient’s drug therapy, the clinician is prompted to select an intervention that best documents the action that was taken to address the safety issue. Navigating through the application is simple and self-intuitive. The results of the interventions are available through the MUET ProClarity cube (used for aggregate reporting and trend analysis). The summary results of the intervention are available the following business day. MUET will be utilized as the main vehicle to conduct some of our future medication safety initiatives. The current VAMedSAFE Risk Reduction Projects will be transitioned to this web application in the coming months.
Did
you know that
the first medication safety initiative utilizing MUET was the
Erythropoiesis Stimulating Agent class (ESAs)? The ESA MUET was piloted
by several VISNs during the latter half of FY2009, and was recently
approved for VA-wide use in February 2010. This graph depicts the number of interventions
that were completed each month to address at-risk patients. Click HERE
to learn more about how to access MUE Tracker and the findings of the ESA
MUET. For iinformation on how to
access MUET https://medora.va.gov/MedSafe_portal/
or to request a training session, please contact: Von.Moore@va.gov or Muriel.Burk@va.gov. Ophthalmic Multivitamins for Age-Related Macular Degeneration The Medical Advisor Panel, VISN Pharmacist Executives (MAP/VPE) committees and the national ophthalmology group evaluated the ophthalmic multivitamins. A review of the national purchasing data demonstrated that the use of ophthalmic multivitamins was not consistent with the evidence from the medical literature review. In some instances, ophthalmic multivitamins were being denied due to their non-formulary status. The committees believed that VA needs could be met by the use of two products; one product designated as a non-smokers formula and another designated as a smokers formulation. The major differences between the non-smoker and smoker formulation are the lack of Vitamin A and the addition of lutein in the product for smokers.
The formulary options for NON-SMOKERS are I-Caps® AREDS, I-Vite Protect and PreserVision® AREDS. The formulary option for SMOKERS is PreserVision® Lutein Softgels.
CLICK THIS LINK to view a table that compares the clinical formulations of ophthalmic multivitamin products and learn what products were inactivated in the April NDF update. Prepared by: Sue Lenz RPh; Kathy Tortorice PharmD, BCPS; and Berni Heron PharmD, BCOP Pharmacy-Prosthetics-SPD (PPSPD) Workgroup Recommendations Products Discussed During Dec 09 · AIGISRx® Anti-Bacterial Envelope-The device is intended to hold an implantable pacemaker or defibrillator and create a stabile environment for the implanted device and reduce the potential for local infection. Ø The group recommended Prosthetics Service assume responsibility. · Collagen Hemostat-Many products are available. The products are used to stop bleeding during surgical procedures Ø The group recommended SPD to assume responsibility for collagen hemostat type products. · Gliadel Wafers-Each wafer consists of a biodegradable co-polymer which controls the delivery of carmustine into the surgical cavity. It is indicated in recurrent glioblastoma multiforme patients as an adjunct to surgery. Ø The group recommended Pharmacy Service continue to manage Gliadel Wafers · Ozurdex® (Dexamethasone Intravitreal Implant)-The implant is used for the treatment of macular edema following branch central retinal vein or central retinal vein occlusion. It is implanted into the vitreous and does not need to be removed. Ø Because this product is approved as a drug, and can be associated with a number of adverse events and patient selection is important, the group recommended that Pharmacy Service assume responsibility.
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. Decisions made by the workgroup from earlier meetings may be read at this link: Esterified estrogens (EE) tablets were added to the VANF to provide another option to female veterans for the treatment of menopausal symptoms (see Abbreviated Drug Monograph at http://vaww.pbm.va.gov). Other estrogen formulations on the VANF include conjugated equine estrogens (CEE) tablets and vaginal cream and the estradiol transdermal patch. Estrogens are considered overall to be clinically similar, though differences in individual response to a particular product may occur, given the complex pharmacokinetic and pharmacodynamic properties of estrogens. The primary use of estrogen therapy (in combination with a progestin in women with a uterus) is for the treatment of moderate to severe menopausal symptoms, where efficacy and safety have been established. The decision to use estrogen therapy should be made on an individual basis, considering treatment goals, benefits, and risks. The lowest effective estrogen dose should be used for the shortest duration of time. (See the North American Menopause Society 2010 Position Statement for more information: http://www.menopause.org/PSht10.pdf ). Any change in formulation for patients already receiving therapy should be done only with patient and provider knowledge and agreement. Respectfully Submitted, Lisa Longo, Pharm.D., BCPS The Veteran’s Health Administration (VHA) and FDA’s Drug Safety Oversight Board In 2005, the FDA formed the Drug Safety Oversight Board (DSB or Board). It provides advice to the Director of the Center for Drug Evaluation and Research (CDER) on handling and communicating postmarket drug safety issues. Currently, the Board is composed of representatives from three FDA Centers and six other federal agencies including the Veteran’s Health Administration. In 2008, the VHA and the Food and Drug Administration (FDA) entered into a Memorandum of Understanding (MOU) to agree to work together to promote safety initiatives related to FDA-regulated drugs, biologics, medical devices, and foods, including dietary supplements. Members from VHA provide input on critical, ongoing drug safety issues discussed by the DSB and input on how the FDA’s decisions affect the VHA patient population. The DSB meetings are internal; however, a public summary of each meeting is posted on FDA’s website. (http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm082129.htm)
Recent Board Topics: October 2009: Table Splitting http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm191353.htm) March 2010: Development of a Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting (ER/LA) opioid products. http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm209187.htm) Respectfully Submitted, Drug Safety Oversight Board, Office of the Center Director/FDA/CDER
Editor’s Note: 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. If you are 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…send an e-mail to 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. LMS Web-Based Anticoagulation Educational Programs Please note: These courses are NOT mandatory national programs. They are being provided as an option for medical centers to use to meet the Joint Commission NPSG Element of Performance related to prescriber and staff education. Medical Centers may choose to provide education locally in forums such as staff meetings, newsletters, grand rounds, external programs or other venues. These courses can only be “completed” one time in LMS. If you completed the course previously, you cannot take it again and receive a Certificate of Completion from EES. An updated LMS anticoagulation program with accreditation will be available in May, 2010. Please check the PBM website http://vaww.national.cmop.va.gov/PBM/default.aspx under Distance Learning Broadcast and Other Educational Opportunities tab for further details in the near future. Conference on Antimicrobial Stewardship This conference is being offered by the National Infectious Diseases Program Office, Pharmacy Benefits Management Services and the Employee Education System. There will be three separate conferences (the same conference will be repeated three times) later May through July 2010. Please check the PBM website http://vaww.national.cmop.va.gov/PBM/default.aspx under Distance Learning Broadcast and Other Educational Opportunities tab for more information. VA Form 10-2320, Schedule II, Schedule III Narcotics &Alcohols Register: http://vaww4.va.gov/vaforms/medical/pdf/vha-10-2320-fill.pdf Please note: The Handbook has been updated. The two inclusions not contained in 1108.02, dated February 1,2010 are noted below: Under Responsibilities of the Controlled Substance Coordinator (CSI)…..The CSC is responsible for ensuring that: a. The required inspections are completed in each area that stores controlled substances each month. NOTE: On a rare occasion a given area may go uninspected. However, this area must be inspected in the subsequent month. b. All new CSIs complete the Controlled Substance-Drug Diversion Inspection Certification course available on the LMS prior to participation in the inspection program. Documentation of Certification will be maintained in the LMS. Field Questions: Can VA fill prescriptions written by a private provider? Answer: There are two circumstances where VA can fill prescriptions written by a private physician other than a Fee Basis physician. One is a State home provider for eligible veterans. The other circumstance is based on a 1967 law that allows VA to fill prescriptions for patients who receive an NSC aid and attendance/Housebound pension or the service connected enhanced pension. These are low income patients who require constant attention or are housebound. Click the below link to read the AA/HB regulation covering this policy in 38 CFR section 17.96. http://edocket.access.gpo.gov/cfr_2009/julqtr/pdf/38cfr17.96.pdf Click HERE to read a memorandum dated May 27, 2009 regarding the interim process for veterans residing in State Veterans Homes. Additional SC regulations can be found at the below link to the Federal Register but have not been published in 38 CFR as yet. (see section 51.42b) http://edocket.access.gpo.gov/2008/pdf/E8-28171.pdf
What is a Medical Food? How Does FDA Oversee Medical Foods? READ ALL ABOUT IT HERE |
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Everyone’s schedule is busy so don’t you want to make sure your communication holds value? Have you ever wondered how to send a “No Reply All” message or how to remove yourself from a mailgroup. Take a few minutes to review the PP slides AT THIS LINK for these outlook tips and others. Please consider sharing this with new employees, resident orientation, and/or staff meetings.
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