Doctors and Narcotics–More Training, Please
Reports of individuals abusing or developing a dependence on drugs such as oxycodone, better known as OxyContin, have been around for decades. More recent drugs of choice for thrill-seekers or drug abusers include methadone and fentanyl, both opium-based drugs. But these medications, officially referred to as controlled dangerous substances, are also being improperly prescribed in some cases, leading, in part, to an increase in deaths and serious side effects.
FDA may soon take action, asking doctors to undergo special training to be able to prescribe these powerful narcotics, Dr. Bob Rappaport told The New York Times last week. Rappaport, director of FDA’s Anesthesia, Analgesia and Rheumatology Products division, said the agency is considering recommending additional education for doctors as early as 2009.
According a Dec. 21 FDA release, doctors have inappropriately prescribed the Fentanyl skin patch, whose directions need to be followed exactly to avoid overdose, and patents have incorrectly used it. Methadone has been implicated in more than twice as many deaths as heroin and is close to overreaching deaths related to OxyContin and Vicodin, reported the New York Times. The number of methadone prescriptions went up 700% between 1998 and 2006, and yet, reports the Times, too few doctors understand how patients differ in their responses to the drug.
Under current law, doctors need a license and a registration with the US Drug Enforcement Administration (DEA) to prescribe controlled dangerous substances (not all doctors have to register with DEA if they do not carry out this practice). Registration involves meeting one or more of the following requirements, according to US Code, Title 21, Chapter 13:
- Hold a subspecialty board certification in addiction psychiatry from the American Board of Medical Specialties
- Hold an addiction certification from the American Society of Addiction Medicine
- Hold a subspecialty board certification in addiction medicine from the American Osteopathic Association
- With respect to the treatment and management of opiate-dependent patients, complete not less than eight hours of training
- Participate as an investigator in one or more clinical trials leading to the approval of a related narcotic drug for maintenance or detoxification treatment
- Undergo other training or experience as the doctor’s state medical licensing board considers to demonstrate the ability of the physician to treat and manage opiate-dependent patients
- Undergo other training or experience as the Secretary considers to demonstrate the ability to treat and manage opiate-dependent patients (Note: There is a clause noting that any such criteria are effective only for 3 years, opening the door to continuing education).
Unfortunately, FDA doesn’t have the authority to force doctors to take additional classes beyond the above requirements to learn more about these painkillers and how they should be prescribed and explained to patients. Ideally, however, the agency’s recommendation will push doctors to take this step on their own.
For more on this topic, see these PharmTech stories:
Wyeth Recalls Cold Medicines, Lawmakers Urge FDA Action
FDA Committees Recommend Ban on Cough and Cold Medications for Young Children
Drug Makers Voluntarily Recall OTC Infant Cough and Cold Medications
FDA to Discuss Pediatric OTC Drugs, Warns Against Codeine Use
Was a little confused about your quote about what is needed for a DEA registration. All that is needed for a DEA registration is registration in the State of Practice and a clean history. I guess I was a little confused as to where these other requirements came from?
Thank you,
John P Mudri
It’s about time! So sadly long overdue. And a disgrace on the part of the major medical agency’s and authoritiies like Dr. Rappaport, who listened to testimony during thier investigations into deaths and addictions caused by drugs like OxyContin, since as early as 2001, and took no action. Other than a little slap on the hand of the manufacturer, Purdue, in the form of a warning letter, these boards did nothing to slow the deaths and addictions that were taking place. Deaths and addictions that are continuing to take place today. All because doctors have been given the power and authority to dispense dangerous, life altering drugs, with as much training and education on the subject as a veterinarian has. Worst; the little training/educ. they have is based on questionable science/studies.
The first time these people in positions of authority discovered the extraordinary increase in narcotic prescriptions written, correlated wth the extraordinary number of related death and addiction, all thier efforts should have been designed to contact and enlighten all the doctors holding narcotic licenses. The decision to address the doctors, who were/are giving these drugs out like candy, could have been the advice given by a kindergartener. It was that plainly evident. Why has this taken so long? I wonder if the profits would have reached the Billions, if action to control the doctors had been taken back then. Well, no, actually I don’t wonder.
PS I too am confused about the “requirements” for DEA registration that is listed in this article. I’m wondering if the writer was mistakenly using the requirements a doctor must have to dispense Buprenorphine. As far as I know, as of today, very little is “required” by doctors to hold a simple license to prescribe narcotics/opiates, after he/she graduates. When very little knowlege is required, very big results can occur. As is evidenced in this situation.