Until recently, it has been illegal for physicians in the United States to prescribe narcotics to opioid addicts for the purpose of treating their addiction outside of specially licensed methadone clinics. President Clinton signed a bill on November 17, 2000, however, which amends the Controlled Substances Act to allow qualified physicians to prescribe schedule III, IV or V narcotics for the treatment of opioid addiction from their offices (the Drug Addiction Treatment Act of 2000, HR 4365, http://thomas.loc.gov). This law is expected to have major ramifications for the availability of effective office-based opioid treatment for heroin and other opioid addictions, for pharmaceutical company incentive to develop new medications for this population, and for physician liability in treating opioid addiction.
According to the Narcotic Addict Treatment Act of 1974 (21 U.S.C. 823(g)), physicians may not legally prescribe any narcotic agent for the purpose of opioid detoxification or maintenance outside of special federally-licensed settings. Only limited exceptions to this rule exist. These opioid substitution programs generally administer the schedule II long-acting opioid agonists methadone and LAAM (l-alpha-acetyl-methadol). (Physicians may prescribe narcotic agents to opioid addicts for non addiction-related conditions, however, such as acute or chronic pain.) The purpose of this law, of course, is to put the few unscrupulous "script doctors" who profit by selling narcotic prescriptions out of business, albeit at the cost of denying effective treatment for hundreds of thousands of addicts. The current system of methadone clinics can only handle approximately 180,000 patients per year, which is far fewer than the estimated 810,000 Americans addicted to opioids.
In addition, FDA approval is expected shortly for a schedule V sublingual form (Subutex, Reckitt Benckiser) of the partial opioid agonist buprenorphine, a medication currently available in this country only as an injectable liquid (Buprenex, Reckitt Benckiser) for the treatment of pain. This drug has been used in France to treat opioid addiction since 1996, and has been found effective for opioid maintenance and detoxification in a number of studies. As a partial agonist at the mu opioid receptor, it causes much less euphoria and overdose toxicity than full agonists such as heroin or methadone, including reduced respiratory depression and very low lethality. Buprenorphine may also be approved as a combination product with the pure opioid antagonist naloxone (Suboxone, Reckitt Benckiser), to further reduce the risk of abuse. Prescribers of buprenorphine will be required to have specialized training or experience in substance abuse (such as subspecialty board certification in addiction psychiatry by the American Board of Psychiatry and Neurology, or addiction certification by the American Society of Addiction Medicine), or have a minimum of eight hours of specialized training in the use of this medication. They will have to register with the Department of Health and Human Services, which will monitor prescribing practices and issue practice guidelines, and they can only prescribe for up to a maximum of 30 patients at one time.
The combination of the new law with the anticipated availability of sublingual buprenorphine is expected to lead to dramatically improved quality and availability of office-based treatment for opioid dependence. Forensic psychiatrists involved with addiction treatment (or with malpractice cases concerned with the standard of care for opioid addiction treatment) should stay tuned to the continued evolution of practice standards in this area.