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Did you notice that the Ez-Minutes Newsletter has another partner? Yes, the VPE (VISN Pharmacist Executives) have been added. Many decisions are made by the VPE committee in conjunction with the PBM-MAP, so it only seems appropriate to place VPE on the Ez-billboard. Now, if we could only get the Vitruvian Man (see left upper corner) to read the memo. J |
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PBM-MAP-VPE Ez-Minutes Newsletter wants you to subscribe. The purpose of the PBM-MAP-VPE 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. For NEW subscribers only; click on stxcollage@va.gov with "PBM subscribe" in the subject line to subscribe to the newsletter. If “old” subscribers, (but young at heart), please forward this newsletter to your staff, fellow colleagues, P&T committee members so they may take this opportunity to subscribe.
Editor's Note: The newsletter is in a HTNL 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. 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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INSIDE THIS ISSUE · Posting of National PBM Documents (May-July 2010) · Posting of VAMedSAFE Documents (May-July 2010) · CG vs. MDRD for Dosing Medications in Patients with Impaired Kidney Function · VA Guidance on Potential for Reduced Effectiveness of Clopidogrel · PPSPD Workgroup Recommendations · Accredited Educational Programs · Questions/Answers and Useful Links · Procedure to Request a VA National Formulary Change · VHA and DSB: Drug Safety Oversight Board (DSB): Recent Board Topics · Publications by VA Pharmacists
The next PBM-MAP-VPE Ez Minutes newsletter will be released November 5th, 2010. Mark your calendar. |
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National Safety Bulletins |
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· New Considerations for the Safe and Effective Use of Colchicine (7/15/2010) 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. |
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Crockcroft-Gault (CG) versus Modification of Diet and Renal Disease (MDRD) in Dosing Medication in Patients with Impaired Kidney Function
The article is abbreviated due to space constraints. Please CLICK HERE to read the article in its entirety and to learn more about the clinical usefulness of MDRD vs. CG.
Historically, most medication package inserts indicate dosing recommendations according to estimated creatinine clearance (eCrCl) in mL/min as calculated by the Crockcroft-Gault (CG) equation. More recently, the Modification of Diet and Renal Disease (MDRD) equation has been developed as an estimate of glomerular filtration rate (eGFR) and may be a more accurate equation for estimating GFR in patients with chronic kidney disease (CKD). This equation uses a variable for race but has no weight variable like the CG equation. Dosing with the MDRD equation requires conversion of its usual units of mL/min/1.73m2 to mL/min as is given in the FDA required medication package inserts. It should be noted that the CG estimates CrCl while the MDRD was designed to estimate GFR. The MDRD has not been validated in person’s age 70 years and older.
In September 2009, the National Kidney Disease Education Program (NKDEP) recommended the use of either eGFR or eCrCl to estimate kidney function for dosing medications. In May 2010, the VA revised its summary of information on the use of eGFR and eCrCl for medication dosing in CKD, that in addition to eCrCl, eGFR is a reasonable option for sites that are reporting the isotope dilution mass spectrometry (IDMS)-traceable creatinine value.
Some VA facilities have implemented the IDMS procedure in the past year which will reduce variability between facilities much the same as INRs have standardized PT. If so, labs are required to re-express the MDRD with a new constant to account for the IDMS calibration. It should be noted that the CG equation cannot be standardized in this way because the creatinine method used in its creation is no longer used and study samples are no longer available. As a result, the CG may be less accurate in facilities that have converted to the IDMS traceable measurement of serum creatinine.
If practitioners choose to use eGFR per the MDRD equation for drug dosing, they must first convert its standard output units to mL/min before comparing with recommendations according to eCrCl by CG. Laboratories should ensure that they are using the appropriate MDRD constant if they have changed to the IDMS standard and understand that the CG calibrated values may change with its implementation. Further research and studies must be done with medications to accurately find the appropriate cut-points for eGFR as calculated by the MDRD equation before it can be fully implemented as the standard for medication dosing in patients with CKD. In the interim, clinicians should use their clinical judgment and evaluate patients while understanding the pitfalls of using either equation at this time.
Author: At the time of submission, Karsten Duncan, Pharm.D. was a PGY2 Pharmacoeconomics Resident at VISN 21 Sierra Pacific Network VA Guidance on Potential for Reduced Effectiveness of Clopidogrel In case you missed it, below is an excerpt of an e-mail that was sent to the field July 13, 2010.
The American College of Cardiology Foundation (ACCF) Task Force on Clinical Expert Consensus Documents and the American Heart Association (AHA) published a Clinical Alert on approaches to the FDA boxed warning for clopidogrel regarding the potential for reduced effectiveness of the drug in patients who are poor metabolizers of the CYP2C19 enzyme, which is involved in the activation of clopidogrel. There are several ongoing studies that will help clarify the role of genetics and platelet function testing in directing antiplatelet therapy. A Summary of the ACCF/AHA Clinical Alert is found below. The guidance in the ACCF/AHA document does not change any of the recommendations in the PBM documents. The national PBM has solicited the opinions of the MAP, VPE, Cardiology Chief Consultants/FAC and VACO Laboratory services. These groups concur that the PBM recommendations are in agreement with the ACCF/AHA guidance and do not need to be changed.
· Although there is growing evidence on genetic polymorphisms that may affect clopidogrel metabolism and clinical outcomes, there are no evidenced-based data available at this time to develop specific recommendations on the role of routine genetic testing or on strategies to improve the safety and efficacy of specific pharmacologic approaches. · CYP2C19 polymorphisms account for only ~12% of the variability in clopidogrel response, and the positive predictive value of a CYP2C19 variant ranges from 12-20%. · The FDA boxed warning only informs physicians and patients that genetic testing is available; it neither mandates, requires, nor recommends genetic testing, thereby allowing for flexibility in clinical decisions. · Recommendations: o Evidence is insufficient to recommend either routine genetic or platelet function testing at the present time. o Adherence to existing ACCF/AHA guidelines for the use of antiplatelet therapy should remain the foundation for therapy. Compliance with the dual antiplatelet regimen needs to be ensured. o Alternative strategies such as use of prasugrel, higher maintenance doses of clopidogrel (150 mg QD) and higher loading doses of clopidogrel (600 mg given once or twice prior to PCI) may be considered on a case by case basis. o Careful clinical judgment is required to assess the importance of the variability in response to clopidogrel for an individual patient and its associated risk to the patient. Alternative strategies need to be addressed on a patient by patient basis so that risk/benefit issues are evaluated for patient specific factors. Pharmacy-Prosthetics-SPD (PPSPD) Workgroup Recommendations · Catheters § Pharmacy will assume responsibility for management of those catheters that are considered disposable and used by outpatients (e.g. urinary catheters, etc.). If use of a long-term catheter requires use of disposable supplies as an outpatient, pharmacy would be responsible for those supplies. § Prosthetics will assume responsibility for management of those catheters that are considered durable (not disposable) and implanted into a specific patient during a procedure and left in place for >30 days (e.g. dialysis catheter, PleurX catheters, etc.) § SPD-Logistics will assume responsibility for management of those catheters that are disposable and used during an inpatient stay. They will also be responsible for disposable supplies associated with use of any catheter during an inpatient stay. When discharged, the disposable supplies will become the responsibility of pharmacy. In addition, SPD-Logistics will be responsible for those catheters that need to be available for use (e.g. chest tubes, foley catheter, suprapubic catheter, etc.) in inpatients but are implanted during a procedure and left in place (not disposable).
· Anti-thromboembolic stockings (e.g. thromboembolic stockings (TED hose), compression stockings or Jobst stockings): Thromboembolic stockings or TED hose are generally used for inpatients along with a compression device. In general, they should not be provided for outpatient use since for optimal effectiveness, a compression device should be used. Compression stockings need to be fitted and can be used for inpatients and outpatients. § SPD-Logistics will assume responsibility to manage and provide thromboembolic stockings or TED hose, and compressions stockings or Jobst stockings for inpatients. § Prosthetics will assume responsibility for the management of compression stockings or Jobst stockings for outpatients
· DexCom Glucose Sensors -Used with the DexCom SEVEN Plus continuous blood glucose monitoring system which includes a 7-day sensor and transmitter and durable receiver. It is recommended that the sensors be replaced every 7 days. The device provides for continuous glucose monitoring (CGM) to identify trends in glucose or high and low values as often as every 5 minutes. § Prosthetics will continue to provide the durable part of the DexCom CGM system using their current process of completing a form 2641 requiring approval by Dr. Len Pogach. § Pharmacy will be responsible for managing the sensors for outpatients o Please note, for inpatients, SPD-Logistics generally provides disposable parts of the system, however due to the expected very limited use of this product; the decision for management of inpatients will be left to the VISNs/facilities to decide.
Additional products discussed during the April, 2010 meeting included: Baby powder, shampoo, lotion for inpatients, Dignicare Stool Management System, Rotaglide Lubricant, Promiseb Topical Cream. For recommendations on these products, please click HERE
Products discussed during the June, 2010 meeting included: dermabond, diapers/incontinence products for inpatients, bedpans for outpatients, and systems to manage laryngectomies. Recommendations for these products are located AT THIS LINK
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. CLICK HERE In December 2006, the FDA ordered all manufacturers of “unapproved” quinine to cease manufacturing and marketing of their products since these “unapproved” products lacked adequate labeling intended to warn patients and providers of the appropriate indications for use and the potential for serious adverse events that can occur with quinine. In July, 2010 FDA released a safety announcement pertaining to the “off label” use of quinine. In FY 2006, there were 43,146 veterans being prescribed quinine. Make an educated guess……How many veterans are being prescribed quinine in FY2010 through May, 2010? Do you know what quinine is FDA approved for? CLICK HERETO LEARN THE ANSWERS AND READ ALL ABOUT IT Accredited Educational Programs · Anticoagulation LMS Programs: “Anticoagulation Education Basic Module”, VA Item 6720 is available (www.lms.va.gov) and accredited for ACPE (pharmacy technicians only), ANCC (including LPNs), CA BRN, and CDR (dietitians) for one year. “Anticoagulation Education Advanced Module”, VA Item 6719, is also available on LMS. This module is accredited for ACCME, ACPE, ANCC, and CA BRN for one year. Please note the determination of participants for which programs to view if used is by the discretion of local facility and/or VISNs. These programs are not mandatory. In the past, facilities have assigned these as mandatory programs for all staff. Medical Centers should also consider using the results of anticoagulation quality assurance and performance improvement activities in determining educational needs to improve staff competence. Contact Janet Dailey Janet.Dailey@va.gov with any questions or additional information. · VA Adverse Drug Event Reporting System – ADE Report Entry and Building Reports: ACPE CE Program August 25th, 26th, and 31st 2010 (1-3 PM EST) This program is for VA pharmacists and pharmacy technicians who report or participate in reporting adverse drug events. The program will teach users about the VA ADERS system, report entry, report retrieval, and how to access the information from the VA ADERS canned reports and VA ADERS ProClarity Cube. This program is approved for 1 hour of ACPE Continuing Education. The first hour of the program is required to receive CE credit. The second hour will be used to demonstrate canned reports and ProClarity. Participants are only required to participate for one day. You may register at: http://vaww.national.cmop.va.gov/PBM/VAADERS/Lists/VA%20ADERS%20CE%20Needs%20Assessment%20and%20Registration/overview.aspx Live Meeting. VANTS information to join the meeting and registration information will be sent via Outlook. Any questions may be directed to Von Moore via e-mail (von.moore@va.gov) or by phone (765-674-3321x73809).
· Treating Osteoporosis in Male Veterans- coming in September/October 2010 · Generic Substitution in Epilepsy Therapy- ACPE will be available for this program as an independent Study via CDN thru November. 30, 2010 · Minimizing Anticoagulant Bleeding- ACPE accreditation has been extended for this program as an independent Study via CDN thru September 30, 2012Click HERE and open the Under Distance Learning Broadcast folder for more program information 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. Questions/Answers and Useful Links: Over the past 3 months, questions sent via pharmacy list serve were compiled. We hope the links will help others in the field.
Q1: Can VISNs alter National Criteria for Use documents? Q2. Where can I find the policy for dispensing non formulary meds to a patient transferring from one VA to another? Q3. Where can I find the guidance for compassionate use of Nutriceuticals? Q4: Where are the PBM criteria for drugs which are considered cosmetic?
Answers to the questions (Q1-Q4) can be found in the VHA Handbook 1108.08, VHA Formulary Management Process on the PBM website or http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1834. Refer to page 11, 14, 15, and 17 for the answers for Q1, Q2, Q3, and Q4 respectively.
Q5: Any guidance to providing medications to veterans living in foreign countries? See VA Foreign Medical Program: http://www4.va.gov/HAC/forbeneficiaries/fmp/handbook/FMP-Handbook-121009web.pdf Q6: What is the status of reviews being done at National PBM? Q7: Is there any Guidance for off-label prescribing?
Did you know that the VA/DoD Bipolar Clinical Practice Guidelines were recently posted? Check it out and other Clinical Practice Guidelines on the OQP website: http://www.healthquality.va.gov/ Requests for change in VANF status (click on above link) 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. The Veteran’s Health Administration (VHA) and FDA’s Drug Safety Oversight Board The FDA Drug Safety Oversight Board (DSB) discussed two topics at the April 2010 and the June 2010 meetings. A link to the Public Summary of each meeting is included. In addition to the regular VHA representative on the DSB, in April 2010, Dr. Charles Anderson, Chief of Radiology for the Veterans Health Administration (VHA), joined the DSB as a guest expert. Dr. Anderson shared data regarding X-ray and CT testing trends at the VHA.
Update on Recent Board Topics: April 2010: CT scans, radiation exposure, and cancer risk; Bisphosphonates and a potential risk of atypical femoral shaft fracture http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm213437.htm June 2010: Gadolinium-based contrast agents and renal adverse events and anaphylaxis; Meta-analysis update http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm219567.htm
Editor’s Note: As mentioned in last issue, 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. Click HERE to review topics from the Oct. 2009 and March 2010 meetings. If you have any feedback to the DSB, please contact Steven Osborne, MD, Executive Director of the Drug Safety Oversight Board. |
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Publications by VA Pharmacists (← CLICK ON THE LINK) Hey VA Pharmacists: The site to host publications by VA Pharmacists has been revised. Check out the above link and see what your colleagues are researching/reporting. The PBM again would like to request VA pharmacists to send your published articles/studies starting from 2009 on. Don’t be shy….send them to Janet.Dailey@va.gov for posting. |