Obama Administration Releases Plan to Deal with Prescription Drug Abuse Epidemic

Latest plan to confront opioid misuse, abuse, and diversion calls for stepped-up education, monitoring, proper disposal, and enforcement efforts.

Today the White House Director of National Drug Control Policy and other federal health officials announced the launch of the administration’s “comprehensive action plan to address the national prescription drug abuse epidemic.”

According to a news release put out by the Office of National Drug Control Policy (ONDCP), the plan will include “new Federal requirements aimed at educating the medical community about proper prescribing practices.”

Titled "Epidemic: Responding to America's Prescription Drug Abuse Crisis,” the plan introduces a national framework for reducing prescription drug misuse, abuse, and diversion by:

• Supporting the expansion of state-based prescription drug monitoring programs
• Recommending more convenient and environmentally responsible disposal methods to remove unused medications from the home
• Supporting education for patients and healthcare providers
• Reducing the prevalence of pill mills and doctor shopping through enforcement efforts

According to the ONDCP release, the FDA will also announce a new Opioids Risk Evaluation and Mitigation Strategy (REMS) program that will “require manufacturers of long-acting and extended-release opioids to provide educational programs to prescribers of these medications, as well as materials prescribers can use when counseling patients about the risks and benefits of opioid use.”

Howard K. Koh, MD, MPH, Assistant Secretary for Health, said that this new plan “coordinates a public health approach with a public safety approach, offers hope and health to our nation.”

According to the introduction to the plan, “The number of prescriptions filled for opioid pain relievers—some of the most powerful medications available—has increased dramatically in recent years. From 1997 to 2007, the milligram per person use of prescription opioids in the U.S. increased from 74 milligrams to 369 milligrams, an increase of 402 percent. In addition, in 2000, retail pharmacies dispensed 174 million prescriptions for opioids; by 2009, 257 million prescriptions were dispensed, an increase of 48 percent.”

The plan identifies several “action items” to improve provider and health care consumer education, including:

• Requiring practitioners who request DEA registration to prescribe controlled substances “to be trained on responsible opioid prescribing practices as a precondition of registration. This training would include assessing and addressing signs of abuse and/or dependence.”
• Work with “appropriate medical and healthcare boards to encourage them to require education curricula in health professional schools” and CME programs to “include instruction on the safe and appropriate use of opioids to treat pain while minimizing the risk of addiction and substance abuse.”
• Consult with medical specialty organizations to “develop methods of assessing the adequacy and effectiveness of pain treatment in patients and in patient populations, to better inform the appropriate use of opioid pain medications.”

The plan also calls for the establishment of effective prescription drug monitoring programs (PDMP) in every state (43 states currently have authorized PDMPs; 35 states have operational programs), and the reauthorization by Congress of the National All Schedules Prescription Electronic Reporting (NASPER) Act.

One interesting proposal in the plan is a directive to “evaluate the feasibility of providing reimbursement to prescribers who check PDMPs before writing controlled substance prescriptions for patients covered under insurance plans.” The plan also calls for the DEA and CMS to issue the Final Rule on DEA Electronic Prescribing of Controlled Substances.

On the enforcement side of the equation, the plan calls for a continuation of current “aggressive enforcement actions against pain clinics and prescribers who are not prescribing within the usual course of practice and not for legitimate medical purposes.” This will be accompanied by efforts to “work with the appropriate groups to write and disseminate a Model Pain Clinic Regulation Law.” PDMP data will be used to “identify criminal prescribers and clinics by the volume of selected drugs prescribed” and identify “doctor shoppers” by their numbers of prescribers or pharmacies. All data is encouraged to be shared among prescribers and clinics to pharmacies, law enforcement, and insurance providers.

The complete text of “Epidemic: Responding to America's Prescription Drug Abuse Crisis” can be downloaded as a PDF file.

The FDA offers more information on the FDA's Opioids Risk Evaluation and Mitigation Strategies at this site.

Although the plan calls for increased patient and provider training and education, this report on Vermont Public Radio noted that an expert advisory panel told the FDA last summer that any REMS proposal that did not call for mandatory training would be insufficient to the task of curbing opioid abuse, misuse, and diversion and voted 25-10 against the REMS approach proposed then by the FDA. A summary of the FDA advisory meeting is available here.

HCPLive wants to know:

Were you surprised by any provision in this latest plan to prevent the misuse, abuse, and diversion of prescription opioid medications?

Will the calls for enhanced training and patient education have any effect if they are not mandatory?

Do you support the increased use of prescription drug monitoring databases and other forms of electronic monitoring and surveillance of physicians’ prescribing habits?

Are you familiar with the concept of the Model Pain Clinic Regulation Law? What should such a statute call for?

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