FDA estimates that more than 33 million Americans misused these painkillers in 2007—up from 29 million five years earlier. These drugs are associated with more emergency room visits, and unintentional overdose deaths involving opioids nearly quadrupled from about 3,000 in 1999 to more than 11,000 in 2007. Drug treatment programs are seeing more young patients coming in either addicted to opioid prescription drugs or in the first years of heroin use that started with opioids, explains Deni Carise, chief clinical officer at Phoenix House, a leading national drug abuse treatment provider, noting that "people think that taking a prescription drug is okay."
Yet millions of individuals rely on these powerful painkillers to mitigate the pain of cancer, surgery, and other conditions, complicating REMS approaches. Patient advocates and physicians strongly oppose limited distribution or registration systems that could curb access to these vital therapies.Conversely, drug abuse groups want to expand the scope of the REMS to include immediate-release pain medications, such as short-acting Vicodin—the most widely prescribed drug in the US, with 131 million prescriptions in 2010, according to IMS Health. The new program is limited to extended-release opioids such as hydromorphone, morphine, oxycodone, oxymorphone, and tapentadol, because these contain a stronger dose of active ingredient and thus are more dangerous when abused.
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To better educate prescribers in the appropriate use of these medications and to alert patients to dangers of drug misuse, FDA wants generic and brand opioid manufacturers to collectively design materials for use by continuing medical education (CME) programs, which agency officials will scrutinize to ensure objectivity, accuracy, and absence of promotional bias. The industry group also will develop common elements for medication guides that pharmacists will give patients.
In addition, companies will devise a collective strategy for evaluating the effectiveness of these educational and monitoring efforts in six months, 12 months, and annually thereafter to meet REMS Elements to Assure Safe Use (ETASU) requirements. Assessments will report on how many prescribers complete educational programs and the program's impact on patient access to opioids—for both appropriate and inappropriate uses. FDA has required similar REMS for two recently approved pain-relief products (Covidien's Exalgo and Purdue Pharma's OxyContin), and these would be incorporated into the new class-wide REMS. FDA wants to receive the industry REMS plan by fall so that the program can go into effect early next year.