The next issue of the PBM-MAP E_z-Minutes Newsletter (Nov. 2009-Jan. 2010) will be released February 5^th, 2010. The PBM-MAP would like to take this opportunity to be the first (we hope) to wish everyone Happy Holidays and a Wonderful New Year!

Warning: This newsletter contains information that will impact clinical practice in the VHA.  Subscribe to it. If you are already a subscriber, forward this newsletter to your staff, fellow colleagues, and P&T committee so they too can subscribe! You won’t regret it. How can NEW subscribers subscribe to this newsletter? Click on stxcollage@va.gov and type in "PBM subscribe" in the subject line and click on “Send.” That’s all it takes…. you are done. Mission accomplished.

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.

INSIDE THIS ISSUE

·       Posting of National PBM Documents Aug-Oct. 09

·       Posting of VAMedSAFE Documents Aug-Oct 09)

·       Pancreatic Replacement Enzymes

·       Policies for Future Reference

·       Pharmacy-Prosthetic Workgroup Decisions

·       Bacitracin Ophthalmic Ointment

·       Use of  Term “½” in Rxs

·       President’s Emergency Plan for AIDS Relief

·       Kudos to CMOP and PBM

·       ASK PBM Clinical E-mail

·       Available CE Programs

·       Request a VANF Formulary Change or Removal

·       Helpful Reminder

·       Submit Pharmacists’ Publications

·       Opportunity for VA Pharmacists in Psychiatry

·       Field Question: Policy for Travel Vaccines and Medications?

Posting of VA Center for Medication Safety VAMedSAFE Documents: Aug-Oct 09

National Safety Bulletins

National PBM Communication

·         Influenza Vaccine Adverse Event Reporting [10-19-09]

·          Vitamin D: High Dose Use and Safety [9-15-09]

·         Dextroamphetamine/Amphetamine 20mg Tablet recall Due to Weight Variability [8-20-09]

·         Fentanyl Transdermal System Recall Due to Leaking Contents [8-20-09]

·         Heparin and Potency Variation [10-02-09]

·         Sitagliptin and Acute Pancreatitis [9-29-09]

Pancreatic Replacement Enzymes

Pancreatic replacement enzymes have been available for treatment of pancreatic insufficiency before the 1938 Federal Food, Drug and Cosmetic Act was passed.  As a result, these agents have been exempt from FDA regulation.  In April 2004, the US Food and Drug Administration (FDA) announced that manufacturers of pancreatic insufficiency products needed approval by the FDA in order to remain on the market. The FDA decided to require approval of new drug applications (NDAs) for all pancreatic extract drug products after data showed substantial variations in drug potency among marketed products thereby affecting the safety and effectiveness of the drugs. By April 2010, pancreatic enzymes are required to have approved NDAs and must be manufactured under the 2006 Guidance for Industry Submitting NDAs for Exocrine Pancreatic Insufficiency Drug Products.

CREON® delayed-release capsules were FDA approved in May 2009 and has replaced CREON® 5, CREON®10, CREON® 20.  This is the first pancrelipase product receive FDA approval.  The new formulation of CREON® has new Prescribing Information, a new dosing schedule, and a Medication Guide to provide important dosing and safety information to patients. CREON® also has new dosage strengths and requires new prescriptions for all patients who have previously been prescribed CREON® 5, 10, or 20. The companies making Viokase, Ultrase, Pancrease, Pancrecarb, and pancrelipase by X-Gen have filed a NDA with the FDA and are awaiting approval. 

Submitted by Debbie Khachikian, PharmDl                                                                                                                      Top of Page

Dual Care National Directive, published August 25^th 2009: http://vaww1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2058

Remember, the 2009  VHA Handbook 1108.08 includes the following policies:

·         Compassionate Use of Nutriceuticals

·         Cosmetic And Enhancement Drugs

Click here to read a detailed document entitled “Nutriceuticals, Compassionate Use in VHA” (formerly White Paper)

Product Reviews:  Decisions by the Pharmacy-Prosthetics Workgroup

Pharmacy Service will be responsible for the following product:

Evicel® Fibrin Sealant (Human): blood based product used to control bleeding during a surgical procedure when achieving hemostasis by standard surgical techniques is ineffective or impractical. Predecessor product was Crosseal which is no longer available.

Prosthetics Service will be responsible for the following products:

Zyplast® (bovine collagen implant): implanted into a patient during a procedure and left in place

Integra® Flowable Wound Matrix: administered as a “filler” into a tunneled wound and covered with a secondary dressing

SPD Service will be responsible for the following product:

Trufill® Liquid Embolic System (n-Butyl Cyanoacrylate): used as a part of a surgical procedure (cerebral AVM resection)

Bacitracin Ophthalmic Ointment is an antibiotic preparation for treatment of ophthalmic gram positive organisms.  It has been used in conjunctivitis, blepharitis and bacterial keratitis.  It was recently removed from the VA National Formulary.  Click here to review other alternative formulary products to treat ocular infections.  Please note that the erythromycin ophthalmic ointment is in short supply at this time, but based on an updated bulletin from American Society Health-System Pharmacists (ASHP), the shortage is expected to end in 2010. 

Submitted by Berni Heron, Pharm.D.,BCOP

Use of the Term “1/2” in Prescription Directions for Use

During the September 09 MAP/VPE meeting, it was recommended that the language in the VHA Handbook 1108.8 be changed to read “Directions on the prescription label must reflect the exact product and dosing instructions. To avoid misunderstanding, providers need to prescribe the medication strength and dose in milligrams (mg) (e.g., simvastatin 40mg tablet. Take 20mg [one-half tablet] daily). To ensure patient understanding, one-half is to be spelled out on the label to avoid misreading “1/2” as 1-2 tablets. This recommendation was approved for the next handbook update.

President’s Emergency Plan for AIDS Relief

In May 2004, in support of the President's Emergency Plan, FDA announced a new initiative to help ensure that those being served by the Presidents' Plan would receive safe, effective, and quality manufactured antiretroviral drugs. This new initiative included an expedited review process. Through guidance and an active outreach program to the pharmaceutical industry, FDA actively encouraged any sponsors worldwide to submit U.S. marketing applications for single entity, fixed dose combination (FDC), and co-packaged versions of previously approved antiretroviral therapies - even if there was still a patent or exclusivity market protection for the product in the U.S. Click here to read more about FDA's special initiative for these products.

ASK PBM Clinical E-Mail

If you’re 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.

Programs accredited for ACPE are still available for the following Independent Studies via CDN:

Transplant Therapy: Treating the Unexpected thru November 30, 2010

Evolving Care in Multiple  Myeloma thru November 30, 2010

Treatment Options for Myelodysplastic Syndromes thru November 30, 2010

Optimizing Therapy When HIV Treatment Fails thru September 30^th, 2010

Minimizing Anticoagulant Bleeding thru September 30, 2010

Generic Substitution in Epilepsy Therapy starting November 23, 2009-November 30, 2010

LMS Anticoagulation Programs:

The Anticoagulation Staff and Prescribers Courses will remain on LMS thru Dec. 31, 2009. These courses are currently being updated/revised. Following 508 compliance review, these courses will be placed on LMS with accreditation by February 2010. The requirements for completing these courses are to be determined by individual facilities and/or VISNs. The programs offer ANCC, ACCME, CA BRN, ACPE, and CDR CEUs. Check the PBM web site under Quick Links >>>Distance Learning Broadcast Program and Educational Opportunity tab for more details.

Requests for change in VANF status may be submitted to the PBM by a VISN Formulary Executive (VPE), the VISN Formulary Executive Committee, the Medical Advisory Panel (MAP), a VHA Chief Medical Consultant or VHA Chief Medical Officer. Procedure to Request a VA National Formulary Change

Procedure to Request  a VA National Formulary (VANF) Removal

An individual or group of field practitioners (i.e. physicians, pharmacists, and nurse practitioners) may submit a request for VANF deletion through their VISN Formulary Committee(s). VACO Chief Consultants may submit forms directly to the National PBM Office. This form does not need to be completed for drug formulations discontinued or removed from the U.S. market. Please see Procedure to Request for Formulary Removal.doc

Helpful Reminder:

To eliminate the need to enter your authentication credentials every time you visit the PBM website, please do the following:

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.

Depending on how your browser is configured, you may or may not need administrative rights on your computer to perform the aforementioned operation; please enlist the assistance of your local IRM support staff if you are unable.                                                                                           Top of Page

Third Call for Publications/Abstracts by VA Pharmacists—Keep Them Coming

The VA PBM Research Steering Committee would like to house publications of articles and/or abstracts by VA pharmacist published for national meetings. Forward your citations and/or abstracts starting from year 2008 to present to Janet.Dailey@va.gov. Citations will be posted to the PBM website. This site will soon have a facelift but the publications/abstracts can still be viewed. CLICK HERE to check out the research being done by your colleagues.

Field Question: Does PBM have any guidance on travel-related vaccines and medications?

The PBM doesn’t have specific policy addressing travel-related vaccines and medications.  The Health eligibility page (http://www.va.gov/healtheligibility/coveredservices/StandardBenefits.asp) indicates that VA provides immunizations. The CDC travel website can be used as reference for appropriate care http://wwwn.cdc.gov/travel/contentVaccinations.aspx