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The next issue of the PBM-MAP Ez-Minutes Newsletter (February -April 2010) will be released when winter finally ends…… May 5th, 2010. J
Please forward this newsletter to your staff, fellow colleagues, and P&T committee so they too can subscribe! NEW subscribers may subscribe to this newsletter by clicking on stxcollage@va.gov and typing in "PBM subscribe" in the subject line. Click to send
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. If you have any comments/questions/suggestions, send them directly to Janet.Dailey@va.gov with Ez-Minutes in the subject line.
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· Posting of National PBM Documents Nov 09 thru Jan 10 · Posting of VAMedSAFE Documents Nov 09 thru Jan 10 · VHA Handbook - Financial Relationships between VHA Health Care Professionals and Industry · Tuberculin Skin Testing: Aplisol® vs. Tubersol® · Pharmacy-Prosthetics-SPD (PPSPD) Workgroup Recommendations · National Directory of Anticoagulation Services · LMS Web-Based Anticoagulation Educational Programs · Conference on Antimicrobial Stewardship |
The VA PBM, Medical Advisory Panel and VISN Pharmacist Executives have provided some interim guidance that can be used when current supplies of gemfibrozil run out. The guidance can be accessed by clicking HERE |
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Posting of VAMedSAFE Documents November 2009- January 2010 |
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National Safety Bulletins |
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· Safety of High Dose Statin-Fibrate Combinations · Sirolimus: Non-Interchangeability of Drug Monitoring Assays |
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VHA Handbook 1004.07 - Financial Relationships between VHA Health Care Professionals and Industry http://www.pbm.va.gov/vamedsafe/Link2.pdf Tuberculin Skin Testing (TST): Aplisol® vs. Tubersol® The Mantoux tuberculin skin test (TST) remains the standard screening tool used to detect infection with Mycobacterium tuberculosis (TB) in patients at risk. Since its availability, the TST has been recognized as having important limitations resulting in false-positive and false-negative reactions. Available reports/evidence that the use the Aplisol® product has led to a higher number of false-positive interpreted reactions compared to the Tubersol® product; especially in instances where a switch was made between products and proper notification was not given.
The Center for Disease Control and Prevention (CDC) Guidelines for Prevention of Transmission of TB infection in Health Care Settings states “Compared to the US reference PPD, no differences exist in TST interpretation between the two commercially available preparations. However, when Tubersol® and Aplisol® were compared to each other, a slight difference in reactivity was observed. Aplisol® produced slightly larger reactions than Tubersol® but the differences were not statistically significant. The difference in specificity 98% (Aplisol®) vs. 99% (Tubersol®) is limited. However when applied in large institutional settings that test thousands of workers annually who are at low risk for infection with M. tuberculosis, this difference in specificity might affect the rate of positive TST results observed.” Because of this, the CDC recommends that TB screening programs should use one antigen consistently and should understand that a change in product may make serial changes in TST results difficult to interpret.
Based upon this information, the VA Medical Advisory Panel, VISN Pharmacist Executives, VA Public Health Strategic Advisory Group, Infectious Disease Field Advisory Committee, Infection Control and Occupational Health have recommended the VA standardize on using one tuberculin reagent for TST with a preference for Tubersol®. Use of Aplisol® will be limited to times of short supply of Tubersol®. The Department of Defense/Joint Forces made a similar decision in 2008 that Tubersol® is their preferred brand. For additional details and references, please see the PBM review of Apliso®l vs. Tubersol® Submitted by Cathy Kelley, PharmD Pharmacy-Prosthetics-SPD (PPSPD) Workgroup Recommendations Products Discussed · Trufill® Liquid Embolic System (n-Butyl Cyanoacrylate): used as a part of a surgical procedure (cerebral AVM resection) (FDA approved September 2000) This agent was initially reviewed in July 2009. This product will continue to be the responsibility of SPD. · Floseal (Hemostatic Matrix): hemostatic agent that stops bleeding in two minutes or less. (FDA approved December 1999) The workgroup agreed that since this item is approved as a device and is used during a surgical procedure that SPD would be responsible. · Diaphragms/Pessaries: The workgroup agreed that pharmacy will be responsible for dispensing diaphragms. Diaphragms are currently listed as a generic entry in the VA drug file and facilities can choose which products to carry. The following link from the American Congress of OB/GYN (ACOG) can be used as an educational reference for pharmacists regarding “barrier-type contraceptive agents” http://www.acog.org/publications/patient_education/bp022.cfm?printerFriendly=yes Prosthetics Service will be responsible for managing pessaries · Medical Maggots: Indicated for debridement of non-healing necrotic skin and soft-tissue wounds such as pressure ulcers, neuropathic foot ulcers, chronic leg ulcers or non-healing traumatic or post-operative wounds. They were approved as medical devices by the FDA in 2004. Because of the very low use of these agents within VA, local sites will determine responsibility for management of these agents on a case by case basis. · LC Bead/Bead Block Compressible Microspheres: Indicated for embolization of hypervascular tumors and arteriovenous malformations (AVMs). The agent is delivered to the intended vessel using typical microcatheters. (FDA approved as a device December 2008) The workgroup recommended that since this agent is a device that is used during a surgical procedure, SPD would be responsible. · Implanon and drug-embedded IUDs: At this time, Prosthetics will continue to be responsible for managing Implanon and drug-embedded IUDs (e.g. Mirena). Pharmacies are encouraged to include implanted product information in their “non-VA medication” section of the pharmacy package since it will not be removed from the medication list over time. However, if a patient moves to another VISN or facility, that information will not follow the patient. There is currently one entry in the National Drug File for “sotalol”. Until recently, the VA had a mandatory use national contract for generic sotalol (this contract has been cancelled due to short supply). The VA will pursue another national contract when adequate supply can be guaranteed.
“Sotalol AF” is also now available as a generic (currently only available from one generic source). “Sotalol” and “sotalol AF” both contain the same active ingredient (sotalol hydrochloride); however, they are considered non-AB rated due to the difference in product labeling (sotalol is indicated for ventricular arrhythmias whereas sotalol AF is approved for atrial fibrillation/atrial flutter). Both sotalol and sotalol AF are available in doses of 80 mg, 120 mg, and 160 mg; only sotalol is available in a 240 mg dose. The MAP/VPE’s have previously determined that while the two products are packaged with different labeling associated with the indication, they are the same chemical entity, and can therefore be therapeutically interchanged in the VA. Differences in the product labeling are outlined in a document available on the PBM Intranet under Clinical Guidance/Drug Monitoring (at http://vaww.national.cmop.va.gov/PBM/Clinical%20Guidance/Drug%20Monitoring/Sotalol%20-%20Sotalol%20AF,%20Drug%20Monitoring.pdf).
In addition, the product packaging for sotalol AF includes a Patient Package Insert (PPI) with information specific for patients with atrial fibrillation/atrial flutter. It should be noted that the patient package insert provided by the manufacturer is not a “medication guide” and is not mandated to be supplied to the patient. In the VA, a Patient Medication Information (PMI) sheet for sotalol is included for all patients who receive sotalol or sotalol AF. If the provider deems it appropriate to provide to the patient, a patient information sheet (pocket card) is available on the VA PBM Intranet under Clinical Guidance/Pocket Cards (http://vaww.national.cmop.va.gov/PBM/Clinical%20Guidance/Pocket%20Cards/Sotalol,%20Patient%20Pocket%20Card.pdf) that includes information specific for patients receiving sotalol (i.e., sotalol or sotalol AF) for atrial fibrillation/atrial flutter.
In order to avoid medication errors, there will continue to be only one entry in the National Drug File for “sotalol”. Sites who wish to designate a separate entry for sotalol and sotalol AF should do so by editing the local drug file name and fill/dispense from the local pharmacy.
Submitted by Elaine Furmaga, PharmD
Azelastine Nasal Spray: Astelin® vs. Astepro®
Recommendation:
. Click HERE to read additional details. Submitted by Cathy Kelley, PharmD The National Directory of Anticoagulation Services It provides readily accessible contact information for one site to communicate with the other and help insure continuity of care for traveling veterans. The spreadsheet can be sorted as desired (e.g. ,by state, VISN, etc.), or use the Find function (ctrl+F) to search for a particular listing. The updated directory is located at the following sites: · VA PBM Intranet site Homepage under Quick Links: http://vaww.national.cmop.va.gov/PBM/default.aspx · VA High Alert Anticoagulant Sharepoint Site: http://vaww.national.cmop.va.gov/HighAlertMedications/Anticoagulants/Forms/AllItems.aspx.
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 April, 2010.Please check the website for further updates.
Save the Date - 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. The conference will be held May 17 to May 18 in Phoenix, AZ; June 28 to June 29 in St. Louis, MO; July 12 to 13 in Boston, MA (same conference but repeated in three separate cities; should only attend conference in one city). More details will forthcoming. Details will be posted on the PBM website. 2010 VHA Board Certified Pharmacotherapy Specialist (BCPS) Study Group has started. It’s not too late. Information regarding the BCPS exam and study group is located at the following link. http://www.bcpsstudygroup.com Exam date: Saturday, October 2, 2010 For additional information and to be part of the VHA-wide BCPS study group: contact Anders Westanmo PharmD, BCPS, MBA at Anders.Westanmo@va.gov 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. 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 Did You Know…extended release dipyridamole/aspirin was not proven superior to clopidogrel therapy for cerebral ischemia prophylaxis? Which agent is used should be based on patient characteristics. Recommendations for the use of clopidogrel in recurrent cerebral ischemic events · Patients with recurrence of cerebral ischemic events while on therapy with aspirin should be changed to an alternate antiplatelet agent. · Both clopidogrel and extended release dipyridamole/aspirin have been proven superior to aspirin in separate trials. · Extended release dipyridamole/aspirin was not able to demonstrate noninferiority to clopidogrel in a randomized, double blinded trial of stroke patients. The findings of the PRoFESS trial demonstrated a lack of evidence that either of the two treatments were superior to the other in prevention of recurrent stroke. · Clopidogrel is an alternative for those patients who have had recurrent cerebrovascular events, who have a documented aspirin allergy, as mentioned above or are intolerant of extended release aspirin/ dipyridamole (recurrent headache). · The combination of aspirin and clopidogrel is not advised for secondary stroke prophylaxis due to increased risk of adverse events demonstrated in the MATCH trial
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