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With the introduction of SharePoint to the PBM web sites, the Ez-Minutes needed an "updated attitude" as well. We hope you will enjoy this trendy-new format. Future issues will be available on a quarterly basis. As a reminder, 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 One National Formulary or the utilization of new Criteria for Use. We want clinicians to be informed earlier than later. For this to happen, we need all healthcare providers to take a minute to subscribe to the newsletter. Please forward this newsletter to your staff, fellow colleagues, P and T committee members so they take this opportunity to subscribe. For NEW subscribers only; click on stxcollage@va.gov with "PBM subscribe" in the subject line to subscribe to the newsletter. Come on now ....that seems Ez enough to do!
Please note, as further updates to the newsletter and websites continue, we welcome any feedback and comments. Let us know how the newsletter can improve so needs of the field are meant. Be sure to let us know what topics you would like included in the next issue. To provide feedback, please send an e-mail directly to Janet.Dailey@va.gov with Ez-Minutes in the subject line. Welcome New MAP Members: Lori Highberger, Acting Chief of Psychiatry at the Carl T. Hayden VAMC in Phoenix, Arizona. Barry Cusack, Chief, Geriatrics Section at the Boise VAMC in Boise, Idaho and former MAP member. Robert S. Rosenstein, Cardiologist, West Palm Beach, Florida.
Welcome New MAP Consultants: Rollin M. Gallagher, Director, Pain Management at the Philadelphia VAMC. Suman Kambhampati, Staff Physician, Division of Hematology and Oncology, Kansas City VAMC, Kansas City, MO. |
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Including Clinical Recommendations; Criteria for Use (CFUs); monographs; Patient/Provider Letter for Procainamide; FAQ regarding Zoster Vaccine. Click to read more. Increased numbers of serious adverse events and deaths have been associated with heparin products. Given the recent events and expected shortages of heparin, alternatives may be considered where clinically appropriate. Check the VAMedSafe and other websites included here for additional information. The safety of calcium supplementation is being questioned in response to a recently published trial that showed trends of increased cardiovascular events in older postmenopausal women who received high doses of calcium citrate. Read on for more details. A clearinghouse of anticoagulation protocols, policies and procedures has been developed and is now posted on the Hi-Alert Medications Sharepoint website. Click to read more details.
Information for the ENDEAVOR stent has been added. White-paper regarding the two VA studies published on ACS and clopidogrel therapy will be forth coming. Read further to learn what the PADRECC Directors and the National PBM recommendations are for tapering of rotigotine.
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Do you need to know the status of a new drug as it moves through the formulary approval process or have a question about criteria for use? Send an e-mail to AskPBMClinical to get an answer. Rates of thiazide use thru FY08Q1 revealed using the Thiazide Performance Measurement. Click to read more. 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. Read on for more details. Two available oncology programs: Myelodysplastic Syndromes (MDS) and Multiple Myeloma. Programs will also be made available as an On Demand Video on the Desktop via CDN (Content Distribution Network). ACPE will be offered. Click to learn more details. New VA pamphlet with information from the Policy and Planning's National Center for Veterans Analysis and Statistics. Information includes current facts and statistics; benefits; health care and memorial affairs; VA toll-free help and information phone numbers and more.
If you missed the conference, here's your chance to watch the presentations. Click to read more.
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| Posting of National PBM Documents Since January 08 | |
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Formulary Decisions: Added to the VA National Formulary (VANF)
Not added to the National Formulary (VANF)
Removed from the VA National Formulary (VANF)
Clinical Recommendations:
Patient and Provider Letters
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Formulary Criteria For Use
Nonformulary Criteria For Use
Drug Monographs
National Safety Bulletins: Aprotinin (Traslol®) - May 16, 2008 Baxter - Allergic Reactions to Heparin Sodium - February 19, 2008 Antiepileptic Drugs and Suicidality - February 11, 2008 Temsirolimus (Torisel®) Final Dose Concentration – January 22, 2008 |
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Increased numbers of serious adverse events and deaths have been associated with heparin products that contained active pharmaceutical ingredient from China, resulting in widespread recalls of Baxter multi- and single-dose vials and heparin flush syringes. The FDA has since identified a contaminant, a heparin-like substance, present in the sampled product. Given the recent events and expected shortages of heparin, alternatives may be considered where clinically appropriate.
See the VA MedSafe website for more complete information on the recall as well as on the use of alternatives: http://www.pbm.va.gov/VACenterForMedicationSafety-DrugSafetyFeatures.aspx FDA website heparin page: http://www.fda.gov/cder/drug/infopage/heparin/default.htm#pha Check out ASHP’s up-to-date information on heparin shortages: http://www.ashp.org/s_ashp/bulletin.asp?id=387&CID=1500&DID=1544&sort=0
Calcium Supplements and CVD in Older Women The safety of calcium supplementation is being questioned in response to a recently published trial that showed trends of increased cardiovascular events in older postmenopausal women who received high doses of calcium citrate. These results were unexpected, as previous studies, although mainly observational, have suggested that calcium may be cardioprotective. It is expected that re-examination of data from earlier clinical trials will be performed in attempt to more clearly demonstrate whether a true risk exists. At this time, it may be reasonable to: 1) Re-evaluate total intake of daily calcium in patients, including intake from dietary sources, before calculating the amount of supplementation needed to achieve target calcium intake; 2) Consider the potential safety concerns along with benefits on bone health on an individual basis. Benefits of calcium supplementation in older women with relatively low risk of fracture may not outweigh the potential cardiovascular risk. See document for additional review of the study and potential implications for practice. It is posted on VA MedSafe: http://www.pbm.va.gov/vamedsafe/FINAL%20Ca%20Supp-CVD%20women%20v3.doc
Hi-Alert Medications-Anticoagulant Project As part of the project, a clearinghouse of anticoagulation protocols, policies and procedures has been developed and is now posted on the Hi-Alert Medications Sharepoint website. http://vaww.national.cmop.va.gov/HighAlertMedications/default.aspx
To view, click on Anticoagulants on the left side of the page. Check out the Master Grid (Excel Sheet) that includes key safety and efficiency elements of an effective anticoagulant monitoring practice which will be help locate documents that may be useful for your site.
The goal of protocol/policy clearinghouse is to provide examples of safe and effective anticoagulation monitoring practices across the VA. Examples of different protocols/policies from over 25 sites are included in hopes that facilities will be able to find elements that they can adapt to suit their particular needs. See individual protocols, policies and procedures listed in the folders on the website. Documents were reviewed by members of the anticoagulation practitioner subgroup. The reviews are included in the respective folders for additional information.
Submitted by:Lisa Longo, PharmD, BCPS Return to the Top |
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As a means to increase our communication with clinicians in the field, VACO Pharmacy Benefits Management Services Clinical Pharmacy Specialists have created a new e-mail address “VHAPBH Ask PBM Clinical” (AskPBMClinical@va.gov) so that questions and comments can be submitted directly to the entire clinical staff. We recognize that busy clinicians do not always know who we are or which one of us to contact if they have a question; many times questions are submitted to VHA Clinical Pharmacists. The new e-mail address is located in Outlook and on the PBM’s intranet home page http://vaww.national.cmop.va.gov/PBM/default.aspx towards the top of the page (under Mission). All questions, comments, and requests will be sent to the entire PBM clinical staff so that the correct person can respond.
So, 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, 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. |
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Neupro Recall
On March 20, 2008, UCB announced that they will be recalling Neupro® (rotigotine transdermal system) in the United States and certain batches in Europe. The recall decision resulted from ongoing monitoring of marketed product, which revealed a deviation from the approved product specification. As a result, there will be an out-of-stock situation with Neupro® in the United States in late April 2008. The manufacturer does not plan on reintroducing a supply of the drug for a prolonged and potentially permanent timeframe. In conjunction with the PADRECC Directors, the National PBM has developed a taper recommendation for rotigotine. Additionally, a suggested dosing regimen for ropinirole has been developed and could be used in those patients who will continue on dopamine agonist therapy. Patients receiving the rotigitone patch should be tapered by 2mg/24 hr until the patch can be discontinued. If an alternate dopamine agonist is indicated, it is suggested to initiate ropinirole tablets 1mg TID if patients were receiving the 6mg/24hr or 4 mg/24hr rotigotine and 0.5mg TID if they were receiving the 2mg/24 hr rotigotine patch. In both instances, the ropinirole dose should be titrated up to an effective dose which is often ≥12mg total daily dose. Initiation of ropinirole may begin during the rotigotine taper. Return to the Top |
Impact of the Thiazide Performance Measure
The goal of the Thiazide Performance Measurement is to promote the evidence-based use of thiazide diuretics in managing patients with hypertension (HTN). The specific aim of the series is to increase thiazide use for those patients with uncomplicated hypertension on both mono and multi-drug therapy. The second part of the series is to provide clinicians with knowledge of the rates of thiazide use in complicated hypertension patients with compelling indications who are already on appropriate therapy for that indication.
n Dataset and Definitions
q Denominator (Uncomplicated HTN) = all patients with ≥ 2 outpatient visits that include the diagnosis of HTN (exclusion criteria/compelling indication applied) within 2 years and who are on Active Rx for HTN (excluding loop diuretics)
q Active Rx = Received at least 1 day supply of antihypertensive medications during evaluation time period
q Compelling indication: outpatients with additional diagnoses that may warrant treatment with a medication other than a thiazide [diabetes, post-myocardial infarction, angina, coronary artery disease (introduced FY07Q2), supraventricular tachyarrhythmia]
q Exclusion criteria: outpatients with additional diagnoses that may exclude use of a thiazide (systolic heart failure, renal failure, SCr > 2, eGFR < 30, spinal cord injury, cor pulmonale, hyponatremia, hyperaldosteronism, prescribed lithium)
n Indicator 1 (2007 Threshold: Meet 19%; Exceeds 22%)
q Outpatients with a diagnosis of HTN (uncomplicated) on monotherapy including a thiazide diuretic (Exclusions/Compelling Indications applied)
n Indicator 2 (2007 Threshold: Meet 60%; Exceeds 63%)
q Outpatients with a diagnosis of HTN (uncomplicated) on multi-drug therapy including a thiazide diuretic (Exclusions/Compelling Indications applied)
The data in the following figures depict the increase in utilization of thiazide diuretics as monotherapy in patients with uncomplicated HTN as well as part of a multi-drug regimen.
Indicator 1: During the first quarter of fiscal year 2008 (FY08Q1), nearly 23% of patients are receiving a thiazide diuretic as monotherapy for HTN. Although this has increased since the initiation of the Thiazide Performance Measure, there continues to be room for improvement as evidenced by the percent of patients who have a compelling indication (43.5%) or exclusion (8.5%) in this cohort of patients, leaving 37% of patients on monotherapy for HTN who are eligible but are not prescribed a thiazide.
Indicator 2: For patients on multi-drug therapy, nearly 68% are receiving therapy with a thiazide diuretic with approximately 11% of patients potentially eligible for treatment who are not receiving a thiazide diuretic (taking into consideration the 51.9% of patients with a compelling indication and 14.2% reported to meet the exclusion criteria).
For complete results including data by quarter, VISN, VAMC, compelling indication, and exclusions refer to the "Thiazide Use in Hypertension Briefing Book - Performance Measure" at http://vssc.med.va.gov/products.asp?PgmArea=9.
Submitted by:Elaine Furmaga, PharmD
Percent Thiazide Monotherapy (Indicator 1)
Percent Thiazide Multi-Drug Therapy (Indicator 2)
Percent Thiazide Monotherapy by VISN (FY08Q1)
Percent Thiazide
Multi-Drug Therapy by VISN (FY08Q1)
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.
Note: An individual or group of physicians may submit a request for VANF addition through their VISN Formulary Committee(s).
1. All requests for change in VANF status generated by a VISN Formulary Committee must contain:
a. Minutes of the VFL Committee or other acknowledged meeting in which action was taken on the product (if applicable); and
b. Literature citations that support the recommendation.
2. All requests for addition to the VANF must contain:
a. Criteria for drug use that addresses indications, monitoring, and any efficacy or safety outcomes specific to the veteran population;
b. Completion of the Request for Formulary Review form (Appendix A-1);
c. Completion of the Conflict of Interest Form by the parties presenting the drug for formulary addition (Appendix B-1); and
d. The signature of the VISN Formulary Leader, VHA Chief Medical Consultant, or Chief Medical Officer.
NOTE: Requests should be forwarded to: Pharmacy Benefits Management Services (119D), P.O. Box 126, Hines, IL 60141
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Requests for the change of VANF status, with regard to pharmacy dispensed medical and surgical supplies, may be initiated by the medical center’s Commodity Standards Committee but must be submitted to the VISN Formulary Committee for review prior to forwarding to the PBM for consideration by the MAP and VFLs committees
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The PBM will send acknowledgement of receipt of the request to the submitting committee or individual within 30 days of receipt of a request for change in formulary status or review of a drug class. This response will be in writing and if a national review is to be conducted, will identify the target date for completion.
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The PBM will notify the VISN Formulary Leaders of requests received and seek evidence-based feedback from all VISN Formulary Committees before any decision regarding VANF addition or deletion is made. NOTE: If a review is conducted, a draft will be distributed to VISN Formulary Committees for wide dissemination and comment.
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Products with FDA approval in a category that is not regulated by the FDA will be preferentially selected for addition to the VANF over Non-FDA approved products. Return to the Top
Upcoming PBM-MAP Oncology CE Programs
Treatment Options for Myelodysplastic Syndromes
Air Date: May 28, 1 PM ET; Channel 2 followed by a VANTS conference call. 1-800-767-1750; Access code: 86360#.
Click on the above link for additional dates/times for rebroadcasts including information regarding program materials and CE requirements.
Accreditation: ACCME, ACPE, ANCC, CA BRN
(Pharmacists: View the program during any scheduled air times but you must participate in one of the VANTS calls to receive ACPE credit. A second VANTs call is scheduled for June 26 at 12 noon ET. Same number/access code as first VANTS call)
View the program during the same time/day/channel offered as above from your desktop through the VAKN website. A one-time registration process is required. Click on this link during scheduled air time: http://vaww.vakncdn.lrn.va.gov/default.asp
Program will be available as an On Demand Video on the Desktop via CDN (Content Distribution Network) after September 1st, 2008. ACPE will be offered.
Please check PBM-MAP Distance Learning Broadcast Programs in the near future for details on
Evolving Care in Multiple Myeloma Program. Available in June, 2008.
View the presentations made during the conference. Click on the following website http://vaww.vakncdn.lrn.va.gov/default.asp and type PBM Conference 2008 into the search box.
GET YOUR VA FACTS STRAIGHT WITH NEW PAMPHLET
Talking to a local group? Responding to a question? Preparing for a meeting? Request a copy of the newly updated three-fold, single-sheet pamphlet developed by the Office of the Assistant Secretary for Policy and Planning. The pamphlet contains current facts and statistics about the VA, benefits, health care and memorial affairs, plus it looks at the veteran population and VA’s focus on OIF/OEF veterans. Policy and Planning’s National Center for Veterans Analysis and Statistics provided the information and plans to update the pamphlet annually. The Office of Public Affairs is distributing a very limited supply of printed pamphlets through public affairs channels. Best bet is to download it from the Web at http://www1.va.gov/vetdata/docs/Pamphlet_2-1-08.pdf and print locally as needed.