APhA: Strengthen proposed opioid REMS by recognizing role of
pharmacists
Advisory panels suggest more is needed in FDA’s proposed
REMS for long-acting, extended release opioids.
Two FDA advisory committees last week voted 25-10 not to recommend
FDA’s proposed Risk Evaluation and Mitigation Strategies (REMS)
for long-acting and extended release opioid analgesics. During the
public comment part of the July 22–23 meeting, held in the suburbs
of Washington, DC, APhA recommended that
pharmacists receive outreach and educational materials about the REMS
program, and that FDA recognize the role pharmacists play as the
medication expert on the health care team.
Pharmacists won’t see changes until there’s an
FDA-approved REMS for this drug class.
According to the June 7 Federal Register notice announcing
the meeting, “The need for adequate pain control is an element of
good medical practice. In this context, some persons suffering from pain
need access to potent opioid drug products; however, inappropriate
prescribing, addiction, and death due to prescription opioid abuse and
misuse have been increasing over the last decade.”
Members of the Anesthetic & Life Support Drugs Advisory Committee
and the Drug Safety & Risk Management Advisory Committee
“agreed that a REMS was needed, but they voted no because they
didn’t think the proposal from FDA was all that they thought was
needed,” John Jenkins, MD, Director, Office of New Drugs, Center
for Drug Evaluation and Research, FDA, said at a press conference after
the meeting. Specifically, they wanted training for prescribers to be
mandatory, rather than voluntary, as FDA had proposed.
While FDA will consider the advisory committees’
recommendations, it doesn’t have to follow them exactly. “I
don’t think I can give you a specific timeline, but we do want to
move on this as rapidly as possible,” Jenkins said during the
question-and-answer part of the press conference. “We have to go
back inside internally and discuss it—decide whether we want to
make significant modifications to what we had proposed based on the
committees’ feedback, or whether we want to go forward with what
we had proposed.”
The proposed REMS under discussion last week has a recent history. In
February 2009, FDA notified manufacturers of long-acting and extended
release opioids that their products would require a REMS “to
ensure that the benefits of those products continued to outweigh their
risks,” according to FDA briefing
information for the meeting. The list of targeted opioids
includes long-acting and extended release products formulated with any
of several medications: fentanyl, hydromorphone, methadone, oxycodone,
and oxymorphone.
While the proposed REMS did not include specific requirements for
pharmacists, APhA advocated for the important role played by
pharmacists, as the medication experts on the health care team, in safe
medication use and patient care. “With appropriate time and
resources, pharmacists can further improve public health and education
for those medications requiring a REMS,” Marcie A. Bough, APhA
Director of Federal Regulatory Affairs, said in the APhA comments.
“We challenge FDA and sponsors to continue to evaluate the
potential impact, need for, and ability to compensate for counseling
services at the point of dispensing as part of a REMS
program.”
APhA also expressed appreciation for FDA’s dedication of time
and resources toward a REMS program, and support for several elements of
the proposed program.
The Accreditation Council for Pharmacy Education (ACPE) also spoke
during the meeting, recommending that REMS education be linked to
accredited continuing pharmacy education (CPE) programs as a means of
providing an incentive to pharmacists. "CPE providers should be
encouraged to develop independent activities that support the proper use
of medications under REMS, and ACPE will be working with other key
stakeholders to track, evaluate, and measure the effectiveness of those
activities," Peter H. Vlasses, PharmD, DSc (Hon), Executive Director of
ACPE, said in a news release issued after the meeting.
Related resources on www.pharmacist.com
Diana Yap (dyap)
Posted July 27, 2010, 9:00 am EDT
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