Prescription Drug Abuse Prevention and Treatment Act of 2011

Far-reaching Senate bill would establish mandatory opioid prescribing training for physicians and create comprehensive opioid treatment guidelines.

Far-reaching Senate bill would establish mandatory opioid prescribing training for physicians and create comprehensive opioid treatment guidelines.

With all of the coverage following the recent release of “Epidemic: Responding to America's Prescription Drug Abuse Crisis,” the national action plan to fight prescription drug abuse presented by the White House in conjunction with the Office of National Drug Control Policy, the DEA, and the FDA, readers may also want to take a moment to revisit a complementary bill recently introduced in the US Senate.

The Prescription Drug Abuse and Prevention Act of 2011, introduced in early March by Senator Jay Rockefeller (D-WV), is intended to provide for “increased Federal oversight of prescription opioid treatment and assistance to States in reducing opioid abuse, diversion, and deaths.”

The introduction to the bill listed several “findings,” including:

  • According to the Substance Abuse and Mental Health Services Administration, the proportion of all substance abuse treatment admissions aged 12 or older that reported any pain reliever abuse increased more than 400 percent between 1998 and 2008, from 2.2 to 9.8 percent.
  • In 2008, among the population of the United States aged 12 or older, nonmedical use of prescription pain relievers was the second most prevalent type of illicit drug use, after marijuana use.
  • Prescriptions for methadone have increased by nearly 700 percent from 1998 through 2006.
  • The number of poisoning deaths involving methadone increased nearly 7-fold from almost 790 in 1999 to almost 5,420 in 2006, which is the most rapid increase among opioid analgesics and other narcotics involved in poisoning deaths.
  • Deaths from methadone and other opiates may actually be underreported. There is no comprehensive database of drug-related deaths in the United States.
  • The lack of standardized reporting by Medical Examiners precludes a uniform definition of ‘cause of death’ on death certificates.
  • Every provider who dispenses or who proposes to dispense controlled narcotics, including methadone, whether for pain management or opioid treatment must obtain registration from Drug Enforcement Administration. Unfortunately there is no requirement as a condition of receiving the registration that these practitioners receive any education on the use of these controlled narcotics, including methadone.
  • Current Federal oversight of methadone and other opioids is inadequate to address the growing number of opioid-related overdoses and deaths.
  • Federal legislation is needed to avert opioid abuse, misuse, and death, without reducing patient access to needed care.

The bill covers eight key topics: consumer education, physician education, methadone hydrochloride tablets, opioid treatment programs, clinical standards for controlled substances, prescription drug monitoring, and mortality reporting.

For physicians the key provisions of the bill are as follows:

Physician/Practitioner Education

In order to be “registered to prescribe or otherwise dispense methadone or other opioids,” physicians and other prescribers must comply with a 16-hour training requirement at least once during each three-year period. The training, which will be done through “classroom situations, seminars at professional society meetings, electronic communications, or otherwise,” will focus on the treatment and management of opioid-dependent patients, pain management treatment guidelines, and early detection of opioid addiction, including through such methods as screening, brief intervention, and referral to treatment.

If this bill is passed, these requirements would become effective July 1, 2012. The DEA would use a portion of the licensing fees paid by controlled substance prescribers to fund the enforcement of these educational requirements.

Prescribing/Dispensing Methadone Hydrochloride Tablets

Following approval of this bill, “no individual or entity may prescribe or otherwise dispense a 40-mg diskette of methadone unless such prescription or dispensation is consistent with the methadone 40-mg diskette policy of the Drug Enforcement Administration as in effect on the date of enactment of this Act, except that such prohibition shall extend to hospitals unless such hospitals provide for direct patient supervision with respect to such methadone.” This moratorium would stop should the Controlled Substances Clinical Standards Commission (see below) finalize and publish methadone dosing guidelines that find that 40-mg diskettes of methadone are “safe and clinically appropriate.”

Controlled Substances Clinical Standards Commission

The Secretary of the Department of Health and Human Services shall establish a Controlled Substances Clinical Standards Commission, “composed of representatives from the Administration, the Centers for Disease Control and Prevention, the Food and Drug Administration, the Pain Management Consortia of the National Institutes of Health, and other agencies,” tasked with developing appropriate and safe dosing guidelines for all forms of methadone, guidelines for the reduction of methadone abuse, “conversion factors for use by health care providers in transitioning patients from one opioid to another,” guidelines for initiating pain management with methadone, and “guidelines for both methadone maintenance therapy and pain management that apply to safe and effective use and include detoxification.”

The dosing guidelines created by the Commission shall:

  • Cover “all forms of methadone used for both pain management and opioid treatment programs, including recommendations for maximum daily doses of all forms, including recommendations for the induction process for patients who are newly prescribed methadone”
  • Establish “requirements for individual patient care plans, including initial and follow-up patient physical examination guidelines, and recommendations for screening patients for chronic or acute medical conditions that may cause an immediate and adverse reaction to methadone”
  • Establish consensus guidelines for pain management with prescription opioid drugs

Physicians would be required to comply with the guidelines for initiating pain management with methadone or risk failure to meet Drug Enforcement Administration certification and re-certification requirements.

National Opioid Death Registry

Upon enactment of this act, the National Center for Health Statistics will be required to establish a National Opioid Death Registry to track opioid-related deaths and information related to such deaths. The goal is to create a uniform reporting system for opioid-related deaths that contains the following information:

  • The particular drug formulation used at the time of death
  • The dosage level of the opioid
  • A description of the circumstances surrounding the death in relation to the recommended dosage involved
  • A disclosure of whether the medication involved can be traced back to a physician’s prescription
  • A disclosure of whether the individual was in an opioid treatment program at the time of death
  • The age and sex of the individual, as well as other non-personal information

This bill has been referred to the Senate Health, Education, Labor, and Pensions committee

A news release put out by Senator Rockefeller’s office, said the Prescription Drug Abuse Prevention and Treatment Act is designed to “prevent the unsafe use of prescription drugs and reduce the number of deaths from prescription drugs by promoting both physician and patient education and creating a uniform reporting system for painkiller-related deaths.” Calling this initiative a “top priority,” Rockefeller said this measure will “help reduce the number of deaths from prescription drugs, as well as better assist those facing problems with abuse.”

Commenting on this proposed legislation, the FDA Law Blog pointed out that under the terms put forth, physicians and other prescribers would actually have to “complete 16 hours of specialized pain management training before they could register to prescribe or dispense methadone and other opioids, then complete at least 16 hours of training every three years.”

HCPLive wants to know:

Do you favor enactment of the Prescription Drug Abuse Prevention and Treatment Act of 2011?

Are the new continuing education requirements called for in this bill too onerous for physicians who already face a litany of other CME requirements?

What are your thoughts on the proposed Controlled Substances Clinical Standards Commission? Would you welcome the creation of comprehensive guidelines covering all facets of opioid treatment for pain?

Do you support the creation of a National Opioid Death Registry?

Please leave a comment below!