September 7th, 2006 03:07 EST
Working Together: DEA and the Medical Community
DEA is unveiling a proposed rule that will make it easier for patients with chronic pain or other chronic conditions, to avoid multiple trips to a physician. It will allow a physician to prescribe up to a 90-day supply of Schedule II controlled substances during a single office visit, where medically appropriate.
The Notice of Proposed Rulemaking is accompanied by a policy statement, “Dispensing Controlled Substances for the Treatment of Pain,” which provides information requested by medical professionals regarding DEA’s position on this important issue.
Also new today, DEA is launching a new page on its website (www.dea.gov) called “Cases Against Doctors.” Everyone will be able to see for themselves the criminal acts committed by those few physicians who are subject to prosecution or administrative action each year.
DEA’s guiding principle is to prevent the abuse and diversion of prescription controlled substances, which have become increasingly popular and deadly, without impacting the ability of patients with legitimate need to have full access to pain relief prescribed by their physician. DEA remains committed to the September 2001 Balanced Policy of promoting pain relief and preventing abuse of pain medications.
“We listened to the comments of more than 600 physicians, pharmacists, nurses, patients, and advocates for pain treatment, and studied their concerns carefully. Today’s policy statement is the result of that collaboration. The policy statement reiterates the DEA’s commitment to striking the proper balance to ensure that people who need pain relief get it, and those who abuse it, don’t,” said DEA Administrator Karen P. Tandy.
The new policy statement outlines the longstanding legal requirements on dispensing controlled substances for the treatment of pain. It addresses the requirement that controlled substances be prescribed only for a legitimate medical purpose, examines the issues surrounding the treatment of pain, and elaborates on DEA’s policy for taking appropriate legal action against those very few physicians who illegally prescribe controlled substances.
“We believe that the statement and proposed rule will help the medical professional ensure that only patients who need medication for pain relief get it. The statement reflects an awareness of patients’ needs as well as the importance of preventing any illegal diversion of prescription drugs,” added Administrator Tandy.
The overwhelming majority of medical professionals who provided written input expressed concern about the statutory provision that restricts doctors from refilling schedule II prescriptions. In response, DEA has developed a proposed regulation that clarifies the statute and expressly allows for the issuance of multiple Schedule II prescriptions in appropriate circumstances. This proposed rule, which is being published for public comment as required by law, is intended to make sure patients get the pain relief they need, and that doctors have the latitude to prescribe in a manner consistent with their sound medical judgment, while enabling DEA to fulfill its legal obligation to prevent drug abuse and diversion.
Under the proposed rule, physicians, as they have always done, must determine whether a patient has a legitimate medical need for the prescribed substance, and the physician must be acting in the usual course of professional practice. DEA’s proposed regulation would then permit the physician to issue multiple Schedule II prescriptions, during a single office visit, allowing patients to receive a total of up to a 90-day supply of controlled substances according to the fill date that the doctor gives the pharmacist.
A sixty-day public comment period on the Notice of Proposed Rulemaking begins on September 6, 2006, the date of publication.
To aid doctors in their responsibility to prevent the diversion and abuse of controlled substances, DEA also has updated its Practitioner’s Manual, which has been posted on www.dea.gov today.
Prescription drug abuse is a growing epidemic and requires everyone’s vigilance. Statistics show that:
- Nearly 1 in 10 high school seniors admits to abusing powerful prescription painkillers.
- Today, more new drug users have begun abusing pain relievers (2.4 million) than marijuana (2.1 million) or cocaine (1.0 million).
- 6 million Americans are currently abusing controlled substance prescription drugs- that is more than the number abusing cocaine, heroin, hallucinogens, and inhalants, combined.
- Researchers from the Centers for Disease Control and Prevention report that opioid prescription painkillers now cause more drug overdose deaths than cocaine and heroin combined.
- Admissions to treatment for prescription opiates swelled by a third in just two years (from 46,972 in 2002 to 63,243 in 2004).
The law charges DEA with responsibility to combat this exploding problem by preventing the diversion of legal drugs into the illegal market where they can be abused. The medical community shares DEA’s urgent desire to put an end to this growing and dangerous illegal activity.
“Today’s policy statement reaffirms that DEA wants doctors to treat pain as is appropriate under accepted medical community standards. Physicians acting in accordance with accepted medical practice should be confident that they will not be criminally charged for prescribing all appropriate pain medications,” Administrator Tandy concluded.