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PBM-MAP-VPE Ez-Minutes Newsletter is an on-line quarterly newsletter. In order for the newsletter to automatically be delivered to your InBox, you need to subscribe to it. 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, new Criteria for Use or medication safety issues. 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. For “old” subscribers, (but young at heart), please forward this newsletter to your staff, colleagues, and P&T committee members etc. so they may take this opportunity to subscribe.
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. Any feedback and comments are
welcomed. Send comments to
Janet.Dailey@va.gov
with Ez-Minutes in the subject line.
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INSIDE THIS ISSUE · Posting of National PBM Documents (Nov 2010-January 2011) · Posting of VAMedSAFE Documents (Nov 2010-January 2011) · Slo-Niacin: FDA Warning Letter · Slo-Niacin: Updated Use and AEs in the VA · High-Dose Simvastatin and Muscle Toxicity · Televancin: Increases Coagulation Test Results · Tdap: ACIP Updated Recommendations · Tobacco Use Cessation Treatment Guidance Publications · E-Cigarettes: To Use or Not to Use? · CEUs: PBM-MAP-VPE Educational Programs · Questions/Answers and Useful Links · New Updated PTSD Clinical Practice Guidelines |
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VAMedSAFE
Documents Posted November 2010 - January 2011
National PBM Communications:
·
Dronedaraone
and Adverse Events Reported in ISMP [November, 2010]
·
Propoxyphene
and Cardiac Toxicity [November, 2010]
·
Dronedarone
(Multaq®) and Liver Injury [January, 2011]
Please Note: On the Bulletins and News Alerts
section of the VAMedSAFE
website, 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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Slo-Niacin: FDA Warning Letter
Editor’s
Note: This article was abbreviated due to space limitations. Please
CLICK HERE
to read the
full content.
On January 19th,
2011, the Food and Drug Administration (FDA) issued a warning letter to
Upsher-Smith (manufacturers of Slo-Niacin®) notifying them of their recent
review of the Slo-Niacin® website (www.slo-niacin.com). Several violations of
the Federal Food, Drug and Cosmetic Act were identified. These violations
include the use of therapeutic claims, references and images on the
website which describes Slo-Niacin® improperly. The claims in question imply
that Slo-Niacin® is a drug approved by the FDA to aid in the “diagnosis, cure,
mitigation, treatment or prevention of disease.” The FDA also notes that
Slo-Niacin® is misbranded since the labeling does not provide adequate
instructions for use. Since Slo-Niacin® is not FDA approved; the FDA is
requiring Upsher-Smith to correct these violations.
The FDA action/warning letter does not involve the safety of Slo-Niacin® or any manufacturing violation; only that Upsher-Smith has included therapeutic claims on their website potentially misleading consumers to believe it is an FDA approved drug. The VA PBM, MAP and VPEs are aware that Slo-Niacin® is not an FDA approved drug. However, the available published evidence supports the use of Slo-Niacin® for the management of dyslipidemia. Interested in reading the full response from the PBM, MAP and VPEs? Click on this link to read more.
Slo-Niacin® Optional Conversion in VA-Update on Trends
in Use and Reported Adverse Events
In March 2010, the VA
MAP and the VPEs agreed that an optional conversion of other niacin products to
Slo-Niacin® appeared to be safe and effective. This decision was based upon the
published literature as well a successful conversion experience (pre and
post-lipid levels, LFTs, etc.) of nearly 6,000 patients to Slo-Niacin® at a
large VA facility.
In order to assist facilities in ensuring the conversion was conducted in a
consistent, controlled and safe manner, the PBM in collaboration with the MAP
and VPEs prepared
Slo-Niacin (Patient Letter)
and
Slo-Niacin (Provider Letter)
explaining the conversion and a document addressing
Slo-Niacin Frequently Asked Questions for Providers.
In addition, a recommendation was made that the PBM monitor trends in use
of Slo-Niacin®, Niaspan® and other niacin products (monthly) as well as closely
monitor adverse events (weekly) through the VAs Adverse Events (AE) Reporting
System (VA ADERS). The following information was presented to the MAP and VPEs
during the January, 2011 meetings:
Table 1: Use of Niacin Products in VA (April-November 2010, Unique Patients)
*Unspecified niacin
product
Table2: Niacin Adverse Events (April-October 2010, Total Number of Events Reported)
Table 3: Liver/Muscle Related Adverse Events (April-October 2010)
Since the VA ADERS is
comprised of spontaneously reported AEs, true incidence rates cannot be
determined. However, the PBM examined the number of reported AE/10,000 patients,
as follows:
Table 4: Adverse Events/10,000 Patients
Q3 FY 10=third quarter,
fiscal year 2010, etc.; Q1 FY 11=Usage numbers not available at time of request
Upon review of this
information, the PBM, MAP and VPEs concluded that there were no concerning
signals despite the increasing use of Slo-Niacin® in the VA and suggest that
although one cannot conclude that Slo-Niacin® is safer than Niaspan®, it appears
to have at least a similar safety profile. Trends in the use of niacin products
and adverse events will continue to be monitored.
Submitted
by Cathy Kelley, PharmD
High-Dose Simvastatin (80 mg) and Muscle Toxicity Editor’s Note: This article was abbreviated due to space limitations. Please Click Here to read the full content including: the FDA ongoing safety review and recommendations, review of the SEARCH trial, Jan. 2011 PBM-MAP-VPE discussion, evidence-based literature evaluation and AEs reported in VA ADERS review. PBM-MAP-VPE Recommendations · Reinforce to patients the importance of notifying their healthcare provider if they notice any unexplained muscle pain, tenderness or weakness while receiving statin therapy, especially after initiation of statins or change in statin therapy (e.g., escalation of dose or switch to another statin).
·
Be aware of and adhere to manufacturer dose limits when prescribing statins in
patients receiving drugs known to increase the risk for statin-associated muscle
toxicity (e.g., fibrates, cyclosporine, cytochrome p-450 inhibitors [for
simvastatin, lovastatin and atorvastatin], etc.)
·
Be aware that certain factors may increase an individual’s susceptibility to
statin-associated muscle toxicity including hypothyroidism, renal or liver
impairment, frailty, advanced age, drug-drug interactions, etc. Consider use of
lower statin doses in these patients.
·
Ensure patients are adherent to statin therapy prior to increasing statin doses or
switching statin therapy.
Submitted
by Cathy Kelley, PharmD |
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Televancin: Increase Coagulation
Test Results
Televancin is a lipoglycopeptide antibiotic approved for the treatment of adult
patients with complicated skin and skin structure infections caused by
susceptible Gram-positive bacteria. The drug binds to artificial phospholipid
surfaces which are added to common anticoagulation tests and thus, interferes
with the assembly of coagulation complexes and clotting in vitro. An increase in
PT, INR, aPTT, ACT, and coagulation-based factor Xa may be observed following
televancin administration. This observation has been demonstrated from 0 to 18
hours after televancin administration, and depends on both drug concentration
and the test reagent. With televancin concentrations of 100mcg/mL, PT may
increase by 6-295% over baseline and aPTT may increase by 44-76% over
baseline. (2010 letter from Astellas Pharma Global Development, Inc. to Melinda
Neuhauser, PharmD) To minimize this interaction, blood samples for these tests
should be drawn as close as possible to the next dose of televancin (at or near
the trough). There is no known way to reliably predict the degree of interaction
when blood is drawn within 18 hours of televancin administration.
Reference: Telavancin [Package insert]. Deerfield, IL: Astellas Pharma Inc;
September, 2009.
Submitted by Timothy Millar, PharmD, San
Francisco VAMC, PGY1 Pharmacy Resident
Tdap: Updated Recommendations from the Advisory
Committee on Immunization Practices (ACIP) Editor’s Note: This article was abbreviated due to space limitations. Please Click Here to read the full content.
On 1/14/11 updated recommendations for the use of
Tdap (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine)
were published in the MMWR (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6001a4.htm?s_cid=mm6001a4_w). ACIP now recommends the off-label
use of Tdap for adults aged 65 and older (see recommendations) and also
states that Tdap can be administered regardless of interval since
the last tetanus- or diphtheria-toxoid containing vaccine. Please read the
full report for complete information.
The VHA National Center for Health Promotion and Disease Prevention (NCP), Pharmacy Benefits Management Services (PBM), Office of Public Health and Environmental Hazards (OPHEH) and the Program Office for Infectious Diseases (ID) have reviewed these recommendations and agree they are appropriate for our Veteran population. Summary of updated ACIP recommendations regarding Tdap (for adults) can be Found at this Link.
Submitted
by Melinda Neuhauser, PharmD, MPH
Pharmacy-Prosthetics-SPD (PPSPD)
Workgroup Recommendations
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. Implementation of these recommendations should be coordinated between
services at local sites. The table below depicts the various products reviewed at the October
2010 meetings. The X marks which service(s) is responsible for managing the
respective products. Please refer to
CLICK HERE
for further details and
explanation of the decision process including decisions made from earlier meetings.
**Please note: the previous recommendation for the
management of “Gold Seed Implants” published in the
Aug 2010-October 2010 Ez-Minutes was rescinded post publication. Final
recommendation from the PPSPD Workgroup for this item is pending.**
New Tobacco Use Cessation Treatment Guidance Publications
Three new Tobacco Use Cessation Treatment
Guidance publications are now available for ordering or downloading. These
materials are located at
http://vaww.publichealth.va.gov/smoking/publications.asp, under the heading Tobacco Use Cessation
Treatment Guidance.
The FDA nor the VA
supports the use of e-cigs for tobacco cessation. Read about it more at these
links:
http://vaww.publichealth.va.gov/smoking/index.asp
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm172906.htm
Accredited PBM-MAP-VPE Educational Programs
* Per Field Request: Posted on the PBM website (under
Distance Learning Broadcast and other Educational Opportunities tab) are screen
shots for each respective program. To date, since these programs can only be
taken once, the content is being provided to the field to modify or use for
future use if needed. An update on whether these programs will be “reset” will
be posted later. However, if LMS/EES elects to reset the programs, NO
accreditation will be provided. 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.
Click
HERE and open
the Distance Learning Broadcast folder for more program details
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.
Back by Popular Demand: Helpful Links
for Frequently Asked Questions Click here to view helpful links and answers to frequently asked field questions. This list was included in the August-October 2010 Ez-Minutes. Click on this link to the list…Enjoy!
Updated Clinical Practice Guidelines on PTSD
The VA Office of Quality and Performance has
posted updated Clinical Practice Guideline (CPG) on PTSD. Click on this
http://www.healthquality.va.gov/
The Veteran’s Health Administration
(VHA) and FDA’s Drug Safety Oversight Board (DSB)
The FDA Drug Safety Oversight Board (DSB)
discussed four topics and three topics at the October 2010 and November 2010
meeting, respectively. A link to the Public Summary for each topic is included.
(see below). DSB members
representing the VHA include Drs. C. Bernie Good and Walid F. Gellad (VA
Pittsburgh Healthcare System), Peter Glassman (VA Greater Los Angeles Healthcare
System).
The Board also discussed recently released and
proposed Drug Safety Communications at each meetings. FDA Drug Safety
Communications can be accessed through the following webpage:
http://www.fda.gov/Drugs/DrugSafety/ucm199082.htm
Update on Recent Board Topics:
October 2010: Update on the Sentinel Initiative,
Patient Medication Information (PMI), Glass Syringes and Risk of Adverse Events
Due to Incompatibility with Needleless IV Connectors, Qualaquin (quinine
sulfate) Drug Safety Communication
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm234547.htm
November 2010: Update on Tablet
Splitting/Scoring, Benzocaine and Methemo-globinemia, draft Drug Safety
Communication related to a prescription product used to treat cough.
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm236933.htm
Editor’s Note: As mentioned previously, a new
feature to the newsletter will be including recent updates discussed by the DSB.
We hope that this segment will provide greater awareness among VA healthcare
professionals about the DSB. 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:
Thank you for your submissions. Keep them coming. Click on to the link to see
what your colleagues are researching. The PBM again would like to remind VA
pharmacists to send your published articles/studies starting from 2009 to
current. Please send them to
Janet.Dailey@va.gov for
posting. |
