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FDA's opiod REMS implies there is still value in industry-sponsored CME
The main solution to the nation's opioid abuse epidemic is for pharma companies to devise educational programs for physicians on the dangers of overuse, misuse, and abuse of these widely used painkillers. As part of a White House program to reduce prescription drug abuse and addiction, FDA wants industry to develop educational materials that will make physicians and consumers more aware of the dangers of opioids, as well as their appropriate use in treating pain. This communications program is the main component of a Risk Evaluation and Mitigation Strategy (REMS) to promote safe use of extended-release or long-acting opioids, which have been the subject of FDA/industry negotiations for several years.
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.
The REMS was announced in April by the White House Office of National Drug Control, along with other anti-abuse initiatives: the Centers for Disease Control and Prevention (CDC) will expand monitoring of prescription drug use, and the Drug Enforcement Agency (DEA) will crack down harder on "pill mills" and clinics offering easy access to pain meds. More federal and state "take-back" events will promote proper disposal of unused or expired medications, and state prescription drug monitoring programs will expand databases to track prescriptions and patient use.
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.
FDA adopted this moderate approach for the opioid REMS even though FDA advisory committees rejected such a voluntary educational campaign in July 2010 as too weak to curb abuse. But FDA faces fierce opposition from the medical community to any limited distribution system for opioids, and a broader program would create oversight responsibilities far beyond FDA's capabilities. FDA lacks authority to tell physicians what to prescribe, noted Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER). But FDA can require manufacturers to develop educational materials.
The Obama administration proposes to put teeth into this educational campaign by asking Congress to mandate physician training on opioid use to obtain the DEA registration number needed to prescribe these and other controlled substances. But for now, training is optional for the 600,000 health professionals with DEA licenses to prescribe these drugs. In 2000, Congress approved legislation that requires eight hours of special training for physicians to prescribe and dispense buprenorphine for treating opioid addiction, but this involves much more limited drug use and far fewer physicians. The prospect of Congressional action in the near future is fairly dim, however, due to opposition to mandatory actions likely to limit access to pain meds from the medical pain community as well as manufacturers.
Even though training is voluntary, requiring pharma companies to develop educational materials on opioid use for CME providers raises a host of issues regarding industry involvement in provider education. Most states require CME for physicians to renew medical licenses, which supports a vast physician education network involving both non-profit and commercial CME providers, many certified by the American Council for Continuing Medical Education (ACCME). An Institute of Medicine (IOM) report in 2009 called for eliminating all industry support of CME as the only way to curb drug company influence on prescribers, and many healthcare organizations are adopting such policies. Consequently, the $856 million that drug and medical device companies provided for CME programs in 2009 was down almost 30 percent from $1.2 billion in 2007; although declining, the amount still represents nearly half of the $2 billion spent on CME.
ACCME expects pharma companies will provide independent support for opioid-related CME activities, and most doctors won't complain. Only 15 percent of physicians want to completely remove industry CME funding, according to a recent survey, although 88 percent acknowledge that commercial support biases educational presentations. Doctors evidently feel they can deal with pharma bias, and they don't want to pay more for these programs.
FDA says it will review opioid course materials to eliminate any promotional slant, and ACCME cites a "firewall" policy that permits pharma to fund educational efforts without any say on content or presentation. FDA also may look to outside opioid experts to prepare some of the REMS training materials on prescribing to treat pain, which would moderate industry's role. "It is essential that the information be independent and avoid any commercial overtones," emphasizes CDER deputy director Douglas Throckmorton. Yet, the REMS plan raises objections. Rep. Mary Bono Mack (R-Calif.) complained to FDA commissioner Margaret Hamburg that the agency's actions merely "punt to the drug companies when it comes to prescriber education."
Just how some 16 brand and generic firms will devise a single shared system for educating prescribers and patients, and for monitoring the program's impact, is fairly murky. While components of the educational materials and MedGuides will apply to all drugs in the class, each manufacturer also will have to provide drug-specific information. And a common approach is needed to obtain independent audits of training quality and impact and to survey continuing abuse and deaths.
ACCME says it can support CME assessment by tracking how many physicians take training courses and how much they learn about opioid prescribing. Yet, each company will be responsible for providing post-marketing safety information to FDA on its particular products and will have to monitor CME programs.
It remains to be seen how the opioid REMS affects industry involvement in physician training. "FDA endorsement of industry education should cause the critics of speaker bureaus and industry support of CME to embrace these techniques for improving patient care," says John Kamp, head of the Coalition for Healthcare Communication. "But I'm not holding my breath."