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.
White House Campaign
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.