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FDA Risk Reduction Plan Aims To Reduce
Opioid Abuse, Addiction and Deaths
After several years of hearing evidence and studying the data, the Food and Drug Administration (FDA) has finally announced its new risk reduction program – called a Risk Evaluation and Mitigation Strategy, or REMS – for all extended-release and long-acting opioid painkillers.
(Opioids are the synthetic versions of the naturally derived narcotics made from opium, which are called opiates.)
The program is intended to reduce the national opioid overdose and opioid addiction epidemic, which is claiming hundreds of lives every year across the country and driving thousands to need opioid detox. The FDA list of extended-release and long-acting opioids includes OxyContin, Avinza, Dolophine, Duragesic, and eight other brand names.
Many extended-release opioid painkillers are prescribed for pain that is far less than the original intention for such drugs – extreme chronic pain, such as in terminal cancer.
The result has been a widespread proliferation of these powerful drugs, which the FDA is finally admitting have been “extensively misprescribed, misused, and abused, leading to overdoses, addiction and deaths across the country.”
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Only time will tell if the REMS initiative goes far enough
Working in conjunction with the White House drug initiative, the FDA’s REMS plan includes:
- Educating doctors about “proper pain management, patient selection, and other requirements and improving patient awareness about how to use these drugs safely.”
- Increased funding for state prescription drug monitoring programs (see “Florida’s rescription drug monitoring program is in limbo again”, below.)
- Drug Enforcement Administration (DEA) to step up law enforcement actions against opioid prescribers.
- Take-back programs to reduce problems associated with the leftover pills that find their way into the hands of others.
- A proposal for new legislation requiring doctors and dentists to complete special opioid education, to qualify for DEA registration and permission to prescribe them.
- The REMS plan applies to various brand name products, which use these generic names:
- hydromorphone
- oxycodone
- morphine
- oxymorphone
- methadone
- transdermal fentanyl
- transdermal buprenorphine
The FDA wants the drug companies to create educational materials for patients as well as doctors. Patients would receive “medication guides” that uses “consumer friendly language to explain safe use and disposal.”
The FDA is asking the pharmaceutical companies to “work together to develop a single system for implementing the REMS strategies.” Opioid drug makers have been informed that they have 120 days – four months – to submit a REMS plan to the FDA.
Misuse of opioid painkillers has become the leading cause of death in at least 17 states, ahead of traffic accidents, killing more than 28,000 people annually. In Florida opioid deaths top the list, and opioid detox is at or near the top two of all drug treatments sought.
There are tens of thousands of victims of opioid abuse, dependence and addiction, and thousands of families who have lost loved ones, all of whom hoped for outright banning of the most dangerous opioids, especially a ban on OxyContin.
Only time will tell if the REMS initiative goes far enough to be truly effective.
Florida’s prescription drug monitoring program is in limbo again
Prescription monitoring has proven effective at reducing opioid abuses, overdoses and deaths by reducing doctor shopping and illegal prescriptions in many states. In all, forty-three states already use prescription drug monitoring programs or close to going on line.
In Florida, the state’s planned prescription drug monitoring program was cancelled by the new governor earlier this year. Then, in mid-April, it got a new lease on life when it was re-approved, based on partial funding by a $1 million federal grant.
This week, however, the federal government announced that grants for prescription drug monitoring programs were cancelled, at least for the remainder of this year. This, from a government which loudly proclaims its “war” on prescription drug abuse.
Once again, Florida’s long-anticipated program is again up in the air.
What is most ironic is how the White House REMS initiative officially announced its support for increased funding, in the same week that it announced, through another initiative, the cancellation of such funding.
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