Same Day Multiple Prescriptions
 Why is Our Government Pursuing a War on Doctors?

Free Electronic Newsletter

Treating Addiction and Treating Pain

Treating Addiction and Treating Pain
By David B. Brushwood, R.Ph., J.D.
University of Florida
September 2002

The effective treatment of opioid addiction is inextricably linked with appropriate pain management. The willingness of physicians to prescribe, and of pharmacists to dispense, high dose opioids for the treatment of pain is adversely affected by the abuse of these drugs. Physicians and pharmacists are understandably concerned that a person who appears to be seeking medication for the relief of pain may in fact be an addict seeking a fix. Under federal law it is illegal to prescribe or dispense controlled substances to addicts for detoxification treatment or for maintenance treatment. Some physicians and pharmacists, erring on the side of caution, have denied patients access to legitimate pain therapy, out of concern that they might otherwise be duped into a violation of federal law by a convincing drug addict.

Drug addicts have targeted physicians and pharmacists as a source of drugs, because pharmaceutical grade products are pure and they are consistently available. Although drug abuse treatment centers have been established to assist addicts in managing their addiction, these centers have the capacity to treat fewer than 200,000 patients, while the number of Americans addicted to opiates approaches one million. Opioid addicts who would opt for treatment, if treatment were available, have been forced to rely instead on diversion from legitimate medical purposes, through fraud and theft. These illegal activities have led to conservative practices by physicians and pharmacists. Consequently, legitimate pain patients have, at times, been denied necessary and appropriate medications.

A new law and a new drug product should ease barriers to opioid access by enabling the treatment of drug addiction outside a limited number of federally approved programs. The Drug Addiction Treatment Act of 2000 (DATA) promises to mainstream the treatment of opioid addiction by increasing the options for treatment and destigmatizing the provision of medical care for the treatment of addiction. Under this law, physicians may prescribe, and pharmacists may dispense, Schedule III through V controlled substances that are approved by the FDA for narcotic addiction treatment. Physicians who wish to participate in this activity must certify that they are qualified, and they must obtain authorization from the DEA.

Under the Narcotic Treatment Act of 1974 (NTA), the only drugs available for the treatment of opioid addiction have been methadone and LAAM. These drugs may be provided only in highly regulated inpatient and clinic settings. They cannot be prescribed and dispensed for later outpatient use. The decentralized approach now permitted by DATA represents a huge policy shift that will allow addicts to legally use physicians and pharmacists as care providers rather than as conduits for controlled substance diversion.

Unfortunately, technology has not yet caught up with policy. Although the new law permits physicians to prescribe for addicts those Schedule III through V controlled substances that are specifically approved for this purpose, there are currently no such drugs available.

It is widely believed that sublingual dosage forms of the drug buprenorphine will soon be approved, and that they will become the first products available for use under the authority of DATA. An injectable dosage form of buprenorphine was approved in 1985 for marketing under the trade name Buprenex. Since it is not specifically approved for use in the treatment of addiction, Buprenex cannot be prescribed for that purpose under DATA.

Buprenorphine is a morphine-like drug that is pharmacologically classified as an opioid agonist-antagonist, meaning that it has a ceiling effect. Abuse of buprenorphine has been demonstrated in those countries where a sublingual dosage form has been available. Little abuse or diversion has been associated with injectable buprenorphine since 1985 in the United States. However, other drugs (notably pentazocine and butorphanol) were not identified as the subject of abuse when they were available only in the injectable form, yet they have become subject to abuse and diversion when reformulated as tablets and as nasal spray. In anticipation that the FDA will soon approve a sublingual tablet of buprenorphine, and permit this dosage form to be prescribed for addiction under the authority of DATA, the DEA has recently designated buprenorphine as a Schedule III controlled substance, a more highly restricted classification than the previous designation as Schedule V.

The success of DATA in providing a legitimate alternative to diversion and abuse will depend, in large part, on acceptance by health care providers and the public of community-based substance abuse treatment. If physicians and pharmacists refuse to participate, or if the public reproaches addicts who seek help for their addiction, then addicts may have little incentive to change their practice of acquiring controlled substances through fraud and theft. Physicians and pharmacists will continue to be skeptical of any person who seeks pain relief, concerned that perhaps the person might be a drug addict.

The treatment of addiction made available under the authority of DATA provides an opportunity for physicians and pharmacists to worry less about being the victims of crime or accomplices in crime, and focus more fully on the provision of competent care. It provides a means for even the smallest communities to confront the problem of drug addiction and provide hope rather than incarceration for drug addicts. It gives patients in pain a chance to receive treatment with opioid analgesics, unencumbered by suspicions of abuse and diversion.

David Brushwood is Professor of Pharmacy Health Care Administration at the University of Florida in Gainesville. He is a Mayday Scholar with the American Society of Law, Medicine and Ethics (ASLME). For information about ASLME pain policy projects, go to ASLME.