Fight Against Heroin Addiction : Part 3

by Food and Drug Administration (FDA)

(Page 3 of 4)

Under FDA rules, programs may admit only current addicts with at least a one-year history of addiction, although previously addicted pregnant women at risk of returning to addiction may also be admitted. Methadone maintenance, but not LAAM, is approved for patients under 18 who have twice failed detoxification or other drug-free treatment. A parent, guardian, or other designated responsible adult must sign the consent form.

Enrollment is voluntary. Patients must report to the same program, except in an emergency.

Among other agency requirements, comprehensive programs must provide:

• medical services, counseling, vocational rehabilitation, and treatment plans
• tuberculosis skin testing during the initial medical evaluation
• HIV counseling
• information to women about drug risks to the fetus
• pregnancy tests for women of childbearing potential before admission to LAAM maintenance, and monthly tests thereafter
• individualized dosage to control withdrawal symptoms without causing sedation or other effects of intoxication, with the lowest effective doses for pregnant women
• regular physician review of dosage levels
• observed dosing at the clinic (With methadone, visits are six days a week to start but, with successful treatment, may be reduced with use of take-home doses. With LAAM, visits are every other day to start but eventually may be every third day.)
• complete patient records, which physicians must sign and date to document dosage changes and reasons for reducing visits
• frequent random urine tests for drugs of abuse — including an initial screening test for prospective patients.

Publicly funded treatment accounts for the vast majority of patients in treatment, says FDA's Nightingale. These programs may be free or have sliding scale fees. The cost of private programs varies.

In addition, FDA and SAMHSA in 1993 issued interim narcotic maintenance program standards for heroin addicts who can't get into a nearby comprehensive program within two weeks. The ADAMHA Reorganization Act of 1992 required the standards to reduce the AIDS threat posed by injection of illegal drugs — the major source of new AIDS infection in the general population, according to NIDA. States would guarantee patients' transfer to comprehensive treatment no later than 120 days. Although no clinics have applied to enroll patients in interim programs, any programs adopted would be restricted to public, nonprofit clinics with federal- and state- approved comprehensive programs.

Managing Compliance Problems

FDA field staff inspect programs every two or three years, reporting problems to the agency's regulatory management branch. Follow-up visits are on a case-by-case basis. "If there are serious violations and we send a warning letter," says compliance officer Gerald Hajarian, "three to six months after the program responds with its correction plan, the district inspects again to make sure the violations no longer exist." (The facility must submit its correction plan to FDA within 15 days of receiving the warning letter.)

DEA inspects programs on a routine cycle — or more frequently if a program has a history of violations or pending allegations of impropriety. DEA requires that programs follow all security and record-keeping regulations. Violations may result in actions such as an Investigative Warning or Letter of Admonition for less serious violations, or an Administrative Hearing, Order to Show Cause, or civil or criminal actions for serious violations. States inspect also.

There is continuing concern about some patients selling their take-home methadone doses on the street. In July 1990, FDA, DEA and NIDA warned program sponsors and medical directors that federal and state investigations confirmed increasing diversion of take-home medications, pointing out that diversion was one reason FDA requires frequent urine tests. (A negative test would indicate the patient hadn't taken the take-home medication.) They warned that, if necessary, they would revoke DEA registration or FDA approval.

Indeed, FDA and DEA in 1991 allowed two New York programs to stay open only after they presented evidence showing how they intended to remedy their problems. FDA, DEA, and Texas authorities in 1992 did close two Texas programs, with a third one closing voluntarily. Last February, FDA closed a New Mexico program.

Improving the Programs

Included among the Center for Substance Abuse Treatment's series of Treatment Improvement Protocols (or "TIPS") are several that cover narcotic maintenance treatment. These are developed by non-federal treatment experts.

"We take the scientific research and expertise of leading clinicians," the center's Lubran says, "and translate that into practical guidance that can help states, maintenance programs, and others improve the quality of services."

Several TIPS — some of which are still under development — provide recommendations about the most effective maintenance treatment practices for such groups as pregnant women and infants exposed to methadone, methadone patients who abuse stimulants (especially cocaine), and patients on LAAM treatment.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.