The U.S. Food and Drug Administration (FDA) recently announced that it
will require manufacturers of immediate-release (IR) opioids to provide
training to health care providers who prescribe IR opioids, including
training on safe prescribing practices and consideration of non-opioid
alternatives. The new requirement is the latest step in the
agency’s attempt to curb the misuse of opioid drugs.
As we have previously discussed on this San Diego Injury Blog, many Americans
who are addicted to opioids were initially exposed to opioids via a legal
prescription. Many addicted patients then moved on to higher dose formulations
or more accessible illegal street drugs.
According to the FDA, approximately 90 percent of all opioid pain medications
prescribed (160 million prescriptions annually) are for IR formulations
like hydrocodone and acetaminophen or oxycodone and acetaminophen combinations.
To help prevent the misuse of such “gateway” drugs, the FDA
recently notified 74 manufacturers of IR opioid analgesics intended for
use in the outpatient setting that their drugs will now be subject to
a more stringent set of requirements under a Risk Evaluation and Mitigation
Manufacturers of extended release/long acting opioid analgesics have been
subject to a similar REMS since 2012. As detailed by the FDA, the sponsors
of the ER/LA opioid analgesics have been providing unrestricted grants
to accredited continuing education providers for the development of education
courses for health care professionals based on content outlined by FDA,
which the agency calls the “Blueprint.”
In addition to extending these requirements to manufacturers of IR formulations,
the FDA is also adding content on pain management to the educational “Blueprint”
required under the REMS. This includes principles related to acute and
chronic pain management; non-pharmacologic treatments for pain; and pharmacologic
treatments for pain (both non-opioid analgesic and opioid analgesic).
The revised Blueprint will also cover information about the safe use of
opioids, and basic information about addiction medicine and opioid use
In addition, training will now be made available to other health care professionals
who are involved in the management of patients with pain, including nurses
and pharmacists. “FDA believes that all health care professionals
involved in the management of patients with pain should be educated about
the safe use of opioids so that when they write or dispense a prescription
for an opioid analgesic, or monitor patients receiving an opioid analgesic,
they can help ensure that the product is properly indicated for the patient
and used under appropriate clinical care,”
FDA Commissioner Scott Gottlieb wrote in a blog post.
Given the number of patients that are negligently prescribed opioids, the
FDA’s new requirement is welcome news. According to the agency,
it is also considering “whether there are circumstances when FDA
should require some form of mandatory education for health care professionals,
and how the agency would pursue such a goal.”
If you or a loved one was negligently prescribed opioids, don’t hesitate to
a San Diego medical malpractice lawyer at the Law Offices of Robert Vaage
for a free consultation.