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Dronedarone
Safety Surveillance: Due to potential safety concerns identified during
the VA national drug review of dronedarone, VA MedSAFE was asked to conduct
an ongoing safety surveillance of patients prescribed dronedarone.
Results of these database evaluations are reported on a quarterly basis to
the VA Pharmacy Benefits Management Services (PBM) Medical Advisory Panel
(MAP) and VISN Pharmacist Executives (VPEs). VAMedSAFE and VA ADERS data will
continue to be reviewed and reported to the MAP and VPEs on a regular
basis. Data on thyroid, pulmonary and hepatic adverse events, as well
as drug interaction data with warfarin and other antiarrhythmic agents for
comparison, will be discussed when available. The following is a
snap-shot of the data with a focus on new onset heart failure (HF), HF
exacerbations, and patients with a potential contraindication due to
decompensated HF from 8/1/2009-6/30/2011.
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Patients
without a previous diagnosis of HF (N=1109)
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Patients
with a previous diagnosis of HF (N=293)
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Patients with
recent decompensated HF* (HF hospitalization within 30 days prior to Rx)
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· 1 (0.09%)
hospitalized for HF within 30 days of dronedarone prescription
· 3* (0.27%)
within 90 days
· 7* (0.63%)
within 180 days
*cumulative
within timeframe
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· 6 (2%)
hospitalized for HF within 30 days of dronedarone prescription
· 15* (5%)
within 90 days
· 24* (8%)
within 180 days
These
percentages were slightly less than the amiodarone comparator
group.
*cumulative
within timeframe
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· 14 of 1481
new users of dronedarone (0.95%)
· 1 of these
patients was rehospitalized for HF within 30 days of dronedarone
prescription
*dronedarone
is contraindicated in patients with New York Heart Association (NYHA)
Class IV HF or Class II-III HF with a recent decompensation requiring
hospitalization or referral to a HF clinic (Boxed Warning)
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CLICK
HERE
to read more details including data validation summary from
8/1/2009-3/31/2011; bleeding with warfarin and dronedarone in VA ADERS; and
AEs reported from Q1FY10-Q3FY11
Recommendations
for Providers:
§ Refer to the VA PBM-MAP-VPE Dronedarone,
Criteria for Use for recommendations on the appropriate patient
population, place in therapy, and monitoring and safety considerations for
prescribing dronedarone
§ Refer to VHA
Directive National Dual Care Policy for considerations in the
management of Veterans also receiving care from nonVA providers
§ Continue to report any adverse
reactions with the use of dronedarone by entering the information into
CPRS’ Allergies/ Adverse Reactions field and/or via local reporting
mechanisms. Adverse events should also be reported, as appropriate,
to the VA ADERS program and FDA MedWatch (1-800-FDA-1088, fax 1-800-FDA
0178, online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm,
or by mail)
Submitted
by Elaine Furmaga, PharmD;
National Pharmacy Benefits Management Services
Back To the Top
Intravitreal bevacizumab Update: Preparing bevacizumab (Avastin) for intraocular use
requires using aseptic technique to withdraw doses from a single-use
vial. Bevacizumab (Avastin) is FDA-approved as intravenous therapy
for various cancers. Recent outbreaks of infectious and sterile
endophthalmitis with toxic reaction both within the VA and outside of the
VA have led to vision loss. The FDA released an alert advising the
field to ensure the drug is obtained from appropriate, reliable sources.
National VA leadership met and decided that
bevacizumab (Avastin) use will cease in the VA until it is determined that
the drug was not the cause of these events and the procedures associated
with preparation and administration can be evaluated. This
prohibition of bevacizumab (Avastin) also extended to fee-based
patients. Requests for bevacizumab (Avastin) use, during this
time, were made to VA Central Office on a case-by-case basis.
Since the initial decision to cease use of
bevacizumab (Avastin), forensic laboratory analyses have indicated that
these events within VA were not related to the drug itself. An
inventory of pharmacy practices was taken and current efforts are now
focused on education, the development/assessment of competencies and
standardizing practice for the preparation of bevacizumab (Avastin).
Interim guidance was released on October 31, 2011,
that rescinds the prohibition of the use of intravitreal bevacizumab
(Avastin) by clinically appropriate patients treated by Fee Basis
providers. In addition, the guidance permits VA ophthalmologists to
resume the use of bevacizumab (Avastin), subject to the provisions outlined in the
interim guidance.
CLICK
HERE to read the Updated Interim Guidance on the Use of Intravitreal
Bevacizumab
Submitted
by Berni
Heron, PharmD, BCOP; National Pharmacy Benefits Management
Services
Target dose of Angiotensin II Receptor
Antagonists in Patients with Heart Failure (HF)
The
article is abbreviated due to space constraints. Please CLICK
HERE to read the article in its entirety (including
the references) to learn more about dosing of angiotensin II receptor
antagonists in the management of HF.
The losartan target dose of 150 mg daily in
patients with HF is based on results of the Heart Failure endpoint
Evaluation with the Angiotensin II Antagonist Losartan (HEAAL) study.
This study compared losartan 50 mg with losartan 150 mg daily, with the
primary endpoint of all-cause mortality and HF hospitalizations, in 3846
patients with HF and a left ventricular ejection fraction (LVEF) < 40%
who were intolerant to an angiotensin-converting enzyme inhibitor (ACEI)
(86% reported intolerance due to cough). Seventy-two percent of
patients received concomitant treatment with a beta-adrenergic
blocker. After a median of 4.7 years of follow-up, treatment with
losartan 150 mg resulted in a 10% decrease in the risk for death or HF
hospitalization compared to patients on losartan 50 mg daily (refer to
table below). Hyperkalemia, HTN, kidney impairment, and angioedema
occurred more frequently in the losartan 150 mg treatment group compared to
the 50 mg dose, with no difference in discontinuations due to these adverse
events.
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Losartan
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Primary endpoint
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Hazard ratio
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95% CI
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P
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150 mg
(mean 129+39 mg)
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823
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0.90
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0.82 to 0.99
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0.027
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50 mg
(mean 46+11 mg)
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889
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Review of the above data in addition to a recent
analysis of Swedish HF registry data comparing patients treated with
losartan or candesartan, prompted an evaluation of data in VA patients with
HF to identify if there was a potential gap in the recommended target dose
and the prescribed dose of angiotensin II receptor antagonists used in the
management of HF. According to VA data from 1/1/2011 to 3/31/2011
(refer to table below), approximately 14,500 patients with a diagnosis of
systolic HF were being treated with losartan, with 44% prescribed >
50% of the target dose of 150 mg. During this same timeframe, approximately
10,600 patients with HF were treated with valsartan, with 51% prescribed >
50% of the target dose of 320 mg (recommended 160 mg twice daily).
Data with candesartan are not provided due to the low utilization in VA.
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1/1/2011-3/31/2011
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Losartan
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Valsartan
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Number patients with HF
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14,477
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10,614
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Average daily dose
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66 mg
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156 mg
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Target dose per day
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150 mg
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320 mg
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< 25% target
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3860 (26.7%)
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2229 (21.0%)
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25-49% target
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4230 (29.2%)
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2974 (28.0%)
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50-74% target
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6233 (43.1%)
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2643 (24.9%)
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75-99% target
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8 (0.06%)
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184 (1.7%)
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> 100% target
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146 (1.0%)
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2584 (24.4%)
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Losartan is not currently FDA approved for use in
HF, and the target dose of 150 mg that was studied in the HEAAL trial is
higher than the maximum recommended dose used for other indications (e.g.,
hypertension). Losartan is available in 25 mg, 50 mg and 100 mg
tablets. Of the other available angiotensin II receptor antagonists,
valsartan and candesartan are FDA approved for the treatment of HF.
Reminders
to the Field:
· Losartan is available on the VA
National Formulary (VANF)
· Valsartan is also available on
the VANF, restricted to treatment of patients with systolic HF
· VA National Clinical
Recommendations for the use of the angiotensin II receptor antagonists are
available on the PBM Web sites (www.pbm.va.gov
and http://vaww.pbm.va.gov)
· It is recommended that patients
with systolic HF be maximized on therapy with agents such as an ACEI,
beta-adrenergic blocker, diuretic, and aldosterone antagonist, as
indicated. In some patients (e.g., African-Americans)
hydralazine/nitrates may also be appropriate
· As recommended by national
clinical practice guidelines, an angiotensin II receptor antagonist
may be considered in patients with systolic HF who are intolerant to an
ACEI (for additional recommendations for use of the angiotensin II receptor
antagonists in VA, refer to the document on the PBM Web site as indicated
above)
·
When
using losartan or valsartan for the treatment of HF, it is recommended that
patients be titrated to target doses (i.e., losartan 150 mg daily;
valsartan 160 mg twice daily), whenever possible
Submitted
by Elaine Furmaga, PharmD;
National Pharmacy Benefits Management Services
Back to the Top
Pharmacy-Prosthetics-Logistics
and Acquisitions (PPLA)* Workgroup Recommendations
The table below depicts the various products
reviewed during July-Sept 2001 meetings. The X marks which services(s) is
responsible for managing the respective products. Please CLICK
HERE for
further details and decisions made from earlier meetings.
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Products
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Pharmacy
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Prosthetics
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Logistics
and Acquisitions
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Gravity Feeding Bags
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X (outpatients)
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X (inpatients)
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Provent therapy for sleep apnea in outpatients
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X (outpatients)
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X (inpatients)
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Saline flushes
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X (outpatients)
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X (inpatients)
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Subsequent supplies of disposable cups/bags
associated with the use of the UrinCare System
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X
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TENS units supplies including pads/electrodes and
lead wires
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X (outpatients)
disposable items
such as the pads
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X (outpatients)
durable items
such as TENS unit and electrode (wires)
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X (inpatients)
disposable items
such as the pads
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TubularElastic Bandages (alternative to gauze for
covering wound/wound dressings)
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X (outpatients)
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Tracheostomy straps or tube holders
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X (outpatients)
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X (inpatients)
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UrinCare kit (control device, briefs/jock straps
integral to system and first 2-3 month supply of disposable cups/bags
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X
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Wound vac systems, including portable version
(Snap vac, KCL vac)
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X (outpatients)
all wound vac
including disposable supplies
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X (inpatients)
all wound vacs
including disposable supplies Also responsible for processing used wound
vacs if owned by the medical center
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*The Pharmacy, Prosthetics, Logistics
workgroup was created to help clarify the responsibility for management
(e.g. ordering, storing, purchasing, AND/OR 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. Implementation
of these recommendations should be coordinated between services at local
sites to ensure a smooth transition if recommendations lead to a change in
responsible service.
Any questions should be directed to responsible local service (Pharmacy,
Prosthetics, or Logistics).
Accredited
PBM-MAP-VPE Educational Programs
Taped
PBM-MAP-VPE Programs with No Accreditation
PBM-MAP-VPE
Nov/Dec Combined Webinar: Pharmacy Education Programs Debut for the New
Year. The National PBM Education Advisory Group will debut the PBM
educational programs for the New Year. Information about the CPE
Monitor for pharmacists and technicians, National Needs Assessment, and the
New PBM Educational SharePoint site will
be shared…and more!
Date:
Monday Dec. 19th
at 3 PM EST 1-800-767-1750 Access Code 49792#
Live Meeting Link: Join
the meeting
All PBM-MAP-VPE Live Meeting programs are posted on CDN/TMS with no
accreditation. Please see PBM
Website under Distance Learning Broadcast tab for program slides and additional information.
ASK PBM Clinical E-Mail
If you’ve been eager to know the status of a
new drug as it moves through the formulary approval process, click on the
New Molecular Entity Review List link. http://vaww.national.cmop.va.gov/PBM/New%20Molecular%20Entity/Forms/AllItems.aspx.
If you have a question about criteria for use, medication management
guidance/monitoring 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.
Veteran’s Health Administration
(VHA) and FDA Drug Safety Oversight Board (DSB)
The FDA Drug Safety Oversight Board (DSB) discussed
3 topics at the September 2011 meeting and 2 topics at the October 2011
meeting. The posting of the October Public Summary is pending. The
link to DSB Public Summaries is the following: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm082136.htm.
DSB members representing the VHA include Drs. C. Bernie Good (VA Pittsburgh
Healthcare System), Walid F. Gellad (VA Pittsburgh Healthcare System), and
William Duncan (VA Washington DC Healthcare System). The Board also
discussed recently released and proposed Drug Safety Communications at its
meetings. FDA Drug Safety Communications can be accessed through the
following webpage: http://www.fda.gov/Drugs/DrugSafety/ucm199082.htm.
Editors
Note: We hope providing recent DSB updates will provide greater awareness
among VA healthcare professionals about the DSB. If you have any feedback
to the DSB, please contact Georgianna Lenzi Georgiann.Ienzi@fda.hhs.gov,
DSB Project Manager.
Publications by VA Pharmacists: Keep holding on to your
submissions for now. More details during the PBM December Webinar.
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