On Tuesday, Apr. 19, 2011, officials from FDA, the US Department of Health and Human Services, and the Drug Enforcement Administration introduced President Obama’s plan for curbing prescription-drug diversion and abuse. The plan, titled “Epidemic: Responding to America’s Prescription Drug Abuse Crisis,” aims to expand state-based prescription-drug monitoring programs, recommends convenient and environmentally responsible drug-disposal methods, supports education for patients and healthcare providers, and directs law-enforcement resources against “doctor shopping” (i.e., visiting several prescribers to obtain controlled substances).
To support the president’s plan, FDA is requiring a Risk Evaluation and Mitigation Strategy (REMS) for all extended-release and long-acting opioid medications. This program will require manufacturers of these products to provide educational programs to doctors who prescribe them. Firms also will have to provide materials to help prescribers advise patients about the risks and benefits of opioid use. FDA will review the educational materials that companies develop, and confirm that they are not promotional.
“This is the most far-reaching REMS program that FDA has instituted,” said Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, in a press conference. “The action affects 16 companies, including branded and generic products,” she added.
The main goals of the agency’s new REMS plan are to teach doctors about proper pain management and patient selection, and to teach patients how to use opioid medications safely. As part of the plan, FDA is asking drugmakers to give patients educational materials, including a medication guide that uses consumer-friendly language to explain safe drug use and disposal. The agency is encouraging pharmaceutical manufacturers to collaboratively develop a single system for implementing the REMS strategies. FDA is notifying opioid makers that they must propose a REMS plan within 120 days.
“Long-acting and extended-release opioid drugs have benefit when used properly and are a necessary component of pain management for certain patients, but we know that they pose serious risks when used improperly, with serious negative consequences for individuals, families, and communities,” said FDA Commissioner Margaret A. Hamburg, in a White House press release. “The prescriber-education component of this opioid REMS balances the need for continued access to these medications with stronger measures to reduce their risks.”
The REMS plan does not make doctor training mandatory, but federal agencies are asking Congress to link mandatory physician training to the Drug Enforcement Administration registration number that doctors need to prescribe controlled substances. FDA also will require the risk-management plan to include a method to evaluate whether the education programs are helping to reduce problems associated with long-acting and extended-release opioids.
In addition, sponsors will have to determine whether the REMS adversely affects patient access to opioids. FDA will monitor the situation closely to make sure that access to the medications is not compromised and that the REMS does not unduly burden the healthcare system, said Woodcock.
Drug firms’ risk-reduction measures are expected to become effective in early 2012. The measures will be required for hydromorphone, oxycodone, morphine, oxymorphone, methadone, transdermal fentanyl, and transdermal buprenorphine.
FDA gained the authority to require manufacturers to develop and implement REMS with passage of the FDA Amendments Act of 2007. REMS are intended to ensure that a drug or biological product’s benefits outweigh its risks.
Opioids (e.g., morphine and oxycodone) are synthetic versions of opium used to treat moderate and severe pain. Extended-release and long-acting opioids are extensively misprescribed, misused, and abused, according to an FDA press release. These practices cause overdoses, addiction, and deaths.