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HAPPY NATIONAL HEALTH-SYSTEMS PHARMACY WEEK: OCTOBER 20-24th |
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PBM-MAP Ez-Minutes Newsletter wants you to subscribe to the PBM-MAP Ez-Minutes Newsletter. It doesn't matter if you are a Democrat, Independent, or Republican (note the alphabetical order)....vote YES! It takes a minute and is less expensive than gasoline. It is FREE! What a bargain! For new readers of this newsletter, 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. Here is how you can subscribe... For NEW subscribers only; click on stxcollage@va.gov with "PBM subscribe" in the subject line to subscribe to the newsletter. If you are already an subscriber, (note, I didn't write OLD subscriber) please forward this newsletter to your staff, fellow colleagues, P&T committee members so they may take this opportunity to subscribe. Editor's Note:Thanks to all the comments regarding the new format for the previous issue. For this current issue, we have attempted to make the newsletter a more print-friendly document. Use your print button at the top of the browser and print away. As further updates to the newsletter and websites continue, 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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| VAMedSAFE May 08-Sept.08 | |
| National Safety Bulletins | National PBM Alerts |
National PBM Communication
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Mitoxantrone Associated with Heart Failure The FDA recently released an alert for patients with multiple sclerosis (MS) who are treated with mitoxantrone. The current labeling for mitoxantrone includes a quantitative left ventricular ejection fraction test at baseline and before each dose of the drug given to a patient with MS. Because the drug's toxic effects on the heart can occur long after a course of treatment ends, additional cardiac function testing was recommended if patients later had symptoms suggestive of heart failure. A postmarketing study using insurance claims data and medical record review indicates that the cardiac monitoring recommended in 2005 "is not being performed in a majority of patients with MS treated with mitoxantrone.” The study found four cases of heart failure that developed 4–17 months after the patients had completed mitoxantrone therapy. These findings on late-occurring cardiac toxicity apparently prompted the new recommendation for yearly left ventricular ejection fraction testing. http://www.fda.gov/cder/drug/InfoSheets/HCP/mitroxantroneHCP.htm. http://www.pbm.va.gov/vamedsafe/NATIONAL%20PBM%20RESPONSE_MITOXANTRONE_Final_081808.pdf Natalizumab and Progressive Multifocal Leukoencephalopathy The FDA and the manufacturers of natalizumab (Tysabri®, Biogen-Idec) have reported two additional cases of PML (progressive multifocal leukoencephalopathy). The first case was reported on July 30, 2008 with the second case reported one day later. These were the first reported cases of PML with natalizumab as monotherapy. Providers must remain vigilant for symptoms of PML.To ensure close monitoring, all patients must enroll in the “TOUCH Prescribing Program” by completing an enrollment form. All patients must be thoroughly informed of the risks of natalizumab therapy, and sign a detailed consent form. The patient must be evaluated by an informed health professional before each monthly infusion. Natalizumab should not be given if PML is suspected. The TOUCH program provides guidelines for distinguishing PML from MS including MRI and cerebrospinal fluid assessment for JC virus DNA where PML might be considered. natalizumab MS CFU- update 09 30 08 Natalizumab MSCoE Annual Registry Natalizumab MSCoE Initial Registry Additional helpful links: http://www.fda.gov/cder/drug/InfoSheets/HCP/natalizumab2008HCP.htm http://www.pbm.va.gov/vamedsafe/NATIONAL%20PBM%20COMMUNICATION_NATALIZUMAB_082708.pdf http://www.aan.com/practice/guideline/uploads/298.pdf Submitted by Kathy Tortorice, PharmD, BCPS Return to the Top Bevacizumab for Age Related Macular Degeneration?
During the Second Annual Clinical Pharmacy Meeting (September 23-25, 2008), discussion occurred regarding a potential cost savings of $700,000 by using bevacizumab (Avastin®) for age related macular degeneration (AMD). This has generated some questions regarding the National PBM position on the issue. The use of bevacizumab may be considered for the treatment of AMD according to the off label criteria for use on the PBM intranet site.
Bevacizumab (Avastin), Criteria for Non-Formulary Use
A policy statement has been prepared by the American Academy of Ophthalmology regarding the use of VEGF inhibitors in AMD. A summary statement from this group states, "review of the available literature to date suggests that anti-VEGF pharmacotherapy, delivered by intravitreal injection, is a safe and effective treatment for neovascular AMD for up to 2 years. There is level I evidence to support this conclusion for pegaptanib and ranibizumab, but none for bevacizumab at this time.”
There is a head to head trial of bevacizumab and ranibizumab in AMD being conducted by the National Eye Institute with a starting date of February 2008 and primary outcome completion date of February 2010. More information can be found at
http://www.clinicaltrials.gov/ct2/show/NCT00593450?term=bevacizumab+and+macular+degeneration&rank=16 Reference: MS Ip, IU. Scott, GC Brown, et al. Anti–Vascular Endothelial Growth Factor Pharmacotherapy for Age-Related Macular Degeneration A Report by the American Academy of Ophthalmology. Ophthalmology 2008;115:1837–1846 Submitted by Kathy Tortorice, PharmD, BCPS ESA Medication Use Evaluation Tracker (MUET) Coming Soon Look for information on the Erythropoietin Stimulating Agent (ESA) MUE Tracker (MUET) in the next EZ Minutes Issue. This is an online web application to help track local ESA interventions. Zolpidem/Zolmitriptan Look-Alike Sound-Alike (LASA) Medication Error: Importance of Bar Code Medication Administration (BCMA) Indications Below is an abbreviated review of the incident. To read more. Zolpidem_zolmitriptan for May-Sept. 08 EZMinutes WHAT HAPPENED: A patient with an active “As Needed” (PRN) orders for zolpidem (for insomnia) and zolmitriptan (for migraines) received the wrong medication. DETAILS OF THE INCIDENT: Zolpidem 5mg tab PO QHS PRN was scanned instead of the requested zolmitriptan 2.5mg tab PO q2 hr PRN. Zolpidem passed the scan since it was also an active PRN order and available on the BCMA Virtual Due List (VDL). VAMEDSAFE FINDINGS: Sound-alike similarities for the two medications resulted in the patient not receiving the correct medication. At this particular VA facility, there is a requirement by pharmacy for PRN medications to have an accompanying indication (e.g. for sleep). It was discovered that although the indication for zolpidem appeared on the BCMA screen when the medication was scanned, it was ignored by the medication administrator. Had the information that was provided by the BCMA screen been utilized, it may have prevented the medication error. The reporting site completed a medication aggregate log review for the incident and entered a New Service Request (NSR) for a software solution at the point of administration to alert nurses to the look-alike sound-alike potential between PRN medications. VAMedSAFE RECOMMENDATIONS:
Review and educate staff annually on LASA pairs identified by JCAHO and VA. http://www.jointcommission.org/NR/rdonlyres/C92AAB3F-A9BD-431C-8628-11DD2D1D53CC/0/LASA.pdf http://www.pbm.va.gov/vamedsafe/VA_Specific_LASA.pdf Sulfite Sensitivity and Medication Use Sulfites, metasulfites, and bisulfites are used as preservatives for their antioxidant and antimicrobial properties in foods, drinks, and pharmaceuticals but may cause hypersensitivity reactions in certain individuals.
The overall prevalence of sulfite sensitivity is unknown but is suspected to be low. As per a Food and Drug Administration (FDA) report from the mid-1990s, an estimated 1% of the population is sulfite sensitive, although higher in asthmatic patients (approximately 5-10%).
Upon systemic administration, drugs containing sulfites may cause immediate hypersensitivity reactions with symptoms such as dyspnea, bronchospasm, urticaria, tachycardia, hypotension, and anaphylaxis. Management is aimed at reversal of hypotension and bronchospasm, supportive therapy, and symptom management with intravenous fluids, corticosteroids, epinephrine, bronchodilators, etc. To increase awareness in the VA of the issue of sulfite-sensitivity as it relates to medication administration, PBM recommends the following:
Look for the full summary of the review soon on the VA MedSafe website: http://www.pbm.va.gov/VACenterForMedicationSafety-Index.aspx Submitted by: Lisa Longo, PharmD, BCPS Topical Drug Products Containing Papain On September 23rd 2008, the FDA announced that companies must stop manufacturing and marketing unapproved topical drug products containing papain because of reports of serious adverse events associated with their use. At this time, there are no FDA approved topical products containing papain. We are aware of at least two manufacturers (Healthpoint and Stratus) that intend to comply with the FDA’s notice to stop manufacturing/marketing topical products containing papain by November 24th 2008 and to stop shipment of their product by January 21st 2009. Over the next two weeks, the Medical Advisory Panel and VISN Formulary Leaders will be voting to remove topical products containing papain from the VANF in response to the FDA’s notice. Please share this information with your wound care providers. FDA Register: Notices: http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-22300.pdf Questions and Answers: Papain http://www.fda.gov/cder/news/papain/qa.htm Submitted by: Cathy Kelley, PharmD 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. The PBM’s Medical Advisory Panel and VISN Formulary Leaders: Who are they and what is their role in the VA National Formulary Process? Under the direction of the VA Undersecretary for Health, the VA Pharmacy Benefits Management (PBM) was established in 1995. The PBM was tasked with the development and management of a VA National Formulary. At that time, a VA Medical Advisory Panel (MAP) was convened to act as medical consultants to the PBM. The MAP members are currently comprised of twelve practicing VA physicians from across the country and include general internists, as well as specialists practicing in the areas of cardiology, critical care, endocrinology, geriatrics, infectious disease, and psychiatry. The MAP also includes Clinical Pharmacists from the PBM, a representative from the Department of Defense (DoD), and a VISN Formulary Leader (VFL). In addition to the MAP, all PBM documents are reviewed and approved by the VFL Committee; a group of pharmacists representing each of the 21 VISNs and a MAP member.
The MAP and VFL Committee are an integral component of the VA National Formulary process. When a document is developed by the PBM (e.g., drug monograph, drug class review, criteria for use, therapeutic interchange guidance, etc), the recommendations are reviewed by the MAP members as well as the VFL Committee prior to final approval and posting to the PBM Web site. All recommendations for addition to or deletion from the VA National Formulary are discussed with and voted on by these two National PBM voting bodies. In addition, the PBM-MAP works closely with VHACO Field Advisory Committees (e.g., Cardiology, Dermatology, Diabetes, Gastroenterology, Nephrology, Neurology, Oncology, Ophthalmology, Optometry, Orthopedics, Pain, Pulmonary, Rheumatology, Substance Abuse Disorders, Urology) as well as VHACO Chief Consultants and/or clinical experts (e.g., Cardiology, Endocrinology, Geriatrics and Extended Care, Mental Health, Oncology, Ophthalmology, Women’s Health) for input on VA National Formulary considerations and recommendations for pharmacotherapy. Documents are also disseminated to these groups and the field for review and comment. Comments are reviewed with the MAP and VFL Committee and are considered for incorporation into the final version of the document before approval. For additional information on the PBM, MAP, VFL Committee, and their role in the VA National Formulary Process, please refer to the PBM INTRAnet site at http://vaww.national.cmop.va.gov/PBM/Learn%20About%20PBM/Forms/AllItems.aspx and click on “Learn About PBM”. Submitted by Elaine Furmaga, PharmD Requests for change in VANF status may be submitted to the PBM by a VISN Formulary Committee, the VISN Formulary Leaders Committee (VFL), the Medical Advisory Panel (MAP), a VHA Chief Medical Consultant or VHA Chief Medical Officer. Procedure to Request a VA National Formulary Change Recommendations for Use of Fluorides in Medical Management of Dental Caries Internet http://www1.va.gov/vhapublications/ Intranet http://vaww1.va.gov/vhapublications/ CE Program: Transplant Therapy: Treating the Unexpected October 28th at 2 PM (ET) with VANTs call at 3PM (ET). This will be the last opportunity discuss with the faculty transplant issues. ACPE, ANCC, ACCME available. Dial in number for the VANT call is: 1-800-767-1750; Access Code: 86360#. This program can be viewed on VAKN at the same time/day when it is aired. Click on the VA Catalog link http://vaww.sites.lrn.va.gov/vacatalog/default.asp for more details. Have you ever wondered how to find CE programs in the VA Catalog? To learn all about it, view the PPT tutorial "How to Use the VA Catalog" located on the Distance Learning Broadcast site. Distance Learning Broadcast Programs The following ACPE accredited CDN (Content Distribution Network) Programs are available thru 10/09!
Click on the VA Catalog link to locate the CDN links for these programs. If CDN is not functioning, please contact “EES CDN Support” in Outlook for assistance.
FIELD QUESTION: Is there anything that can be done so I don't have to log in so many times when viewing different web pages on the PBM InTRAnet website? Answer: You can change the setting on your computer so you won't have to log in so many times. This will only work for the InTRAnet. Just follow the directions below.
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