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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 is changes to the National Formulary or new Criteria for Use. We desire ALL clinicians be informed earlier than later. We cannot utilize a single mass mailing so it is up to you to subscribe to Ez-Minutes. Recently, the proposed release dates of future issues were posted. This schedule corresponds to 2-3 weeks after major PBM meetings. So, act now. Don’t delay. Subscribe. Be sure to tell your colleagues too.
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 a subscriber, please forward this newsletter to your staff, fellow colleagues, and P&T committee members so they may take this opportunity to subscribe.
Editor's Note: Thanks to all the comments regarding the previous issue. 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 look at 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, please send them directly to Janet.Dailey@va.gov with Ez-Minutes in the subject line. |
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· Posting of National PBM Documents May-July 09 · Posting of VAMedSAFE Documents May-July 09 · Pharmacy-Prosthetic Workgroup Decisions · Considerations for using Thiazide-Type Diuretics in HTN · Save the Dates-Educational Opportunities · Standardizing Prenatal Vitamins in VA · Medical Advisory Panel (MAP) and VISN Pharmacist Executives (VPE) · Procedure to request VA National Formulary Change · Second call for Publications by VA Pharmacists |
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Posting of VA Center for Medication Safety (VAMedSAFE) Documents: May- July 09 |
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National PBM Bulletins |
FDA MedWatch Safety Alerts |
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· Macrodantin and Macrobid LASA Confusion · Tacrine and Tacrolimus LASA Confusion · Oxybutynin and Oxycodone and Look-Alike/Sound-Alike (LA/SA) Confusion · Risk of Severe Hypoglycemia with Glyburide Use in Elderly Patients with Renal Insufficiency · Varenicline (Chantix®) and Bupropion (Zyban®, Wellbutrin® and generics) and Neuropsychiatric Events National PBM Communication · Regadenoson (Lexiscan®) and Updated Labeling · Leukotriene Inhibitors and Neuropsychiatric Adverse Events · Varenicline and Bupropion and Neuropsychiatric Adverse Events · Medtronic and Quick-Set Infusion Sets Recall · Propofol and Urgent Drug Recall by Teva Due to Contaminated Lots · Citalopram Recall due to tablet size Variance |
· TNF-a Blockers, including Golimumab, (SimponiTM) and Risk of Fungal Infections |
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Decisions from the Pharmacy-Prosthetics Workgroup—Refer to last issue of Ez-Minutes for discussion on the newly developed Pharmacy-Prosthetic Workgroup Implanon® (etonogestrel implant): Implanon® is a non-biodegradable, sterile rod containing etonogestrel for subdermal implantation. Implanon® is a progestin-only, long-acting (up to 3 years) contraceptive agent containing no estrogen. It works by suppressing ovulation, increases viscosity of cervical mucus and leads to changes in the endometrium. Prosthetics Service will be responsible for managing Implanon®.
Retisert® (fluocinolone acetonide) is an intravitreal implant. Retisert® is surgically implanted into the posterior segment of the affected eye in patients with chronic noninfectious uveitis. It is designed to release fluocinolone acetonide locally at an initial rate of 0.6 mcg/day; decreasing over the first month to a steady state release rate of 0.3-0.4 mcg/day for 30 months. Prosthetics Service will assume responsibility for Retisert®. Providers must complete a Prosthetics 2641 form and receive final approval from VA Central Office in order to receive the product. Lisinopril (Zestril®) Labeling Change Recently (May 2009), labeling for lisinopril (Zestril®, AstraZeneca) was revised to include … “and mood alterations (including depressive symptoms)” under Nervous System/Psychiatric in the Adverse Reactions section of the product information (http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm153798.htm). According to the manufacturer, a review of post-marketing surveillance data found that over 40% of the reported cases of depression supported a drug-induced mood disorder; in the remaining cases, there were either inadequate data or the symptoms did not correspond to a diagnosis of depression. Several of the ACEIs including captopril, enalapril, perindopril, quinapril, and ramipril include depression as an adverse event, occurring in less than 1% of patients. In addition, case reports of mania or acute psychosis have been reported in the literature with lisinopril, captopril, and quinapril. Fosinopril also includes wording that behavioral changes and mood changes may occur. Report any of these types of adverse drug events to the FDA MedWatch program via VA ADERS https://medora.va.gov/vaaders/MedSafe_portal/index.asp Submitted by Elaine Furmaga, PharmD Return To the Top Considerations for the Use of Thiazide-Type Diuretics in the Management of Patients with Hypertension (HTN): Review of Recent Evidence The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC 7) and the VA/DoD Clinical Practice Guideline on the Diagnosis and Management of HTN in the Primary Care Setting currently recommend a thiazide-type diuretic as first-line treatment for uncomplicated (i.e., the patient does not have a compelling indication for treatment with an agent other than a thiazide) HTN and as an adjunct agent in most patients when combination therapy is indicated. Since the publication of these guidelines, additional long-term outcome studies have been conducted evaluating antihypertensive therapy compared to a thiazide-type diuretic alone, or in combination with a thiazide-type diuretic. These data have been reviewed and are available at http://vaww.national.cmop.va.gov/PBM/default.aspx under Clinical Guidance/Clinical Recommendations. Since the publication of JNC 7, (JNC 8 anticipated to be released within the next year) other HTN treatment guidelines have made alternate recommendations to thiazide diuretics as first line therapy (e.g., ESH/ESC: thiazide-type diuretic, ACEI, ARB, beta-blocker, or CCB all appropriate first-line therapy for HTN; NICE: thiazide-type diuretic or CCB first-line if > 55 years of age or black, an ACEI first-line if < 55 years).
While evidence from more recent trials (i.e., ANBP-2, ASCOT-BPLA, ACCOMPLISH) should be considered when selecting antihypertensive therapy, it is also important to take into account the selection of thiazide and dose, comparator(s) used, and the endpoints evaluated in the clinical trials. Clinicians may choose to select other medications as first-line treatment in patients with HTN; however, overall, the best available evidence continues to favor a thiazide-type diuretic as the preferred first line therapy in most patients with uncomplicated HTN; and a thiazide should be used in combination with other agents for most patients who require more than one antihypertensive agent. These recommendations will again be reviewed and considered when HTN clinical practice guidelines are updated or as additional clinical trial data are published.
When selecting a thiazide-type diuretic, it is recommended that doses shown to reduce cardiovascular morbidity and mortality in large, randomized, controlled trials be used. More specifically: · If hydrochlorothiazide is prescribed, the goal range is 25 to 50 mg daily; with an initial dose of 12.5 or 25 mg daily (an initial dose of 12.5 mg may be considered for older patients or where initial response should be closely monitored) and titrated to goal as indicated · If chlorthalidone is prescribed, the goal range is 12.5 to 25 mg daily, with an initial dose of 12.5 mg and titrated to 25 mg as indicated
When any thiazide diuretic is initiated or titrated, patients should be monitored for BP response and serum electrolytes (to assess for hypokalemia and/or kidney dysfunction) within 1 month, unless otherwise indicated. Submitted by Elaine Furmaga, PharmD Physician Clinical Support System for Methadone (PCSS-M) is a national, free mentoring network for health care providers prescribing methadone for either opioid addiction or pain. Modeled after the PCSS for buprenorphine (PCSS-B), the program connects providers needing information and mentoring on methadone with national experts via e-mail, telephone, or on-site support. Andrew J. Saxon, Director of Addictions Care Line at the Seattle VAMC is the program’s medical director. PCSS-M is coordinated by the American Society of Addiction Medicine (ASAM) and funded by a grant from The Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Substance Abuse Treatment (CSAT). For more details, go to http://www.pcssmethadone.org. Providers who would like mentoring can sign up online at www.pccssmentor.org, by email at PCSSproject@asam.org, or by calling (877) 630-8812. Save the Dates-Educational Opportunities: Click here for more details. Broadcast Program: “Minimizing Anticoagulant Bleeding” Accreditation: ANCC, ACCME, CA BRN, CDR, ACPE. The last VANTS call is scheduled for Aug. 11th at 3 PM ET Dial in Number is: 1-800-767-1750 Access Code: 86360#. ACPE will be available for this program as an independent Study via CDN starting October 1, 2008 thru October 1, 2009. Live Meeting: “VA Adverse Event Reporting System (VA ADERS): ADE Report Entry and Building Reports” August 4, 6, 12, 2009 at 1-3 PM ET--Dial in Number for all dates: 1-800-767-1750; Access Code: 36551#. Accreditation: ACPE—for pharmacists and pharmacy technicians Web-based Anticoagulation Education Programs: For Staff and Prescribers Accreditation: ANCC, ACCME, CA BRN, CDR, ACPE The web-based programs are currently being revised and will be made available January, 2010. Pharmacy technician accreditations will be added. Broadcast Program: “Generic Substitution in AED”—coming soon in October, 2009. Check the PBM website for details in the near future. Accreditation: ANCC, ACCME, CA BRN, ACPE
Don’t forget ACPE is still available for the following programs as Independent Studies via CDN: “Transplant Therapy: Treating the Unexpected” thru November 3, 2009 “Management of Chronic Hepatitis B” thru September 30th, 2009 "Optimizing Therapy When HIV Treatment Fails" thru September 30th, 2009 Return To the Top Standardizing Prenatal Vitamins in the VA The VISN Pharmacist Executives (VPE) and the National VA PBM are taking steps to standardize prenatal vitamins in the VA. Prenatal vitamin products (over-the-counter or prescription) have not undergone full review, do not have full FDA approval, and may vary greatly in amount and type of ingredients. Significant reformulations with little or no warning and frequent shortages have occurred. The National VA PBM along with the Women’s Health Group developed a list of minimum components for a suitable prenatal vitamin product, which includes requirements for folic acid, calcium, vitamin D, iron, and vitamin A. To allow for more consistency between CMOPs and Medical Centers in product dispensing, multiple VA Product Names for prenatal vitamins in the National Drug File entries have been consolidated to the following: MULTIVITAMINS W/MINERALS, PRENATAL CAP/TAB. As a reminder, prenatal vitamins are supplements and not intended to be the sole source of nutrients. All women of childbearing potential should be counseled on the importance of maintaining a healthy diet. In reviewing national utilization, it was noted that a significant portion of male patients are currently receiving prenatal vitamins. Sites and/or VISNs may wish to review all multivitamin use, product compositions and provide nutritional education if needed. Products specifically labeled prenatal vitamins should be reserved for female maternal use. Suitable multivitamin products and/or other supplements (e.g., folic acid) may be prescribed as appropriate for other patients. Submitted by Lisa Longo, PharmD, BCPS/Melissa Neff, PharmD 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. The PBM’s Medical Advisory Panel and VISN Pharmacist Executives: Who are they and what is their role in the VA National Formulary Process? Read more in the last issue of Ez-Minutes. For additional information on the PBM, MAP, VPE 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”. Remember…..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 Second Call for Publications/Abstracts by VA Pharmacists
Thanks to those that have submitted papers already. As a reminder, the VA PBM Research Steering Committee would like to house publications of articles and/or abstracts by VA pharmacists published for national meetings. Please submit your citations and/or abstracts starting from year 2008 to present to Janet.Dailey@va.gov. Citations will be posted to the PBM website. Your research is much appreciated and will assist other sites in making better informed decisions. Check it out. Click Here
Did you see this? PBM in the NEWS: http://www.ashp.org/import/news/HealthSystemPharmacyNews/newsarticle.aspx?id=3087
Click on the link to review the “DO NOT SUBSTITUTE LIST” http://vaww.national.cmop.va.gov/PBM/National%20Formulary/Forms/AllItems.aspx Having problems getting on PBM website? In order to eliminate the need to enter authentication credentials when you visit the SharePoint site, please perform the following operation on your computer: a) Open an Internet Browser window b) Go to Tools, internet Options, Security Tab c) Click on Local Intranet, then click on Sites. d) Click on Advanced. e) In the "Add this Web site to the zone" type "*.va.gov" without the quotes and then click Add. f) Click Ok until all boxes are closed. Return To the Top |
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