Methadone center warned - Montefiore Methadone Maintenance Treatment Program Unit III, Bronx, New York

FDA Consumer, Oct, 1991 by Tom Cramer, Dixie Farley, Rebecca Williams

FDA recently warned a methadone treatment program in New York City that its program approval would be revoked if it did not comply with safety standards.

Methadone, a synthetic opiate, can help wean heroin addicts from that illegal and potentially fatal drug.

Used in hospital drug treatment centers, methadone blocks the euphoric effects and withdrawal symptoms of heroin. But it also sets up a new addiction as well--to methadone--and withdrawal from the treatment can be just as painful as from heroin itself. Therefore, FDA requires all narcotics treatment centers to meet certain program standards for safety.

Montefiore Methadone Maintenance Treatment Program Unit III, of the Bronx, repeatedly violated standards concerning medical orders, attendance schedules for patients, record keeping, confidentiality of medical charts, urinalyses, and admissions to the program.

FDA found the violations during a routine inspection in February 1985 and then during follow-up inspections in March 1987 and July 1989. FDA sent the treatment center a notice of adverse findings in June 1985 and January 1990. The program managers responded in June 1985, August 1987, and January 1990 with written plasn for correcting the problems.

FDA officials from the New York district also met with Montefiore managers in July 1987 and December 1989 to discuss the violations and plans for correcting them.

When FDA inspected again in September 1990 and found the same violations, the agency said it would revoke approval of the Montefiore program unless its president, Spencer Foreman, M.D., came to FDA headquarters in Rockville, Md., to explain why the program should remain in business and to outline plans for correcting violations.

On March 22, 1991, Foreman met with FDA officials in Rockville. He assured FDA that the program plus two others owned by the Montefiore Medical Center, would implement a number of new procedures in line with federal regulations.

Foreman said the New York State Division of Substance Abuse Services would help review and redesign procedures at the center.

Foreman also said the Montefiore program director had established methods of auditing patients' files regularly to ensure they have adequate treatment plans, proper drug orders, attendance requirements, and admission evaluations. He promised to hold in-service training programs for the staff to teach them about federal standards, and he said he instructed them to change record-keeping procedures so that patients' identities would remain confidential. A new computer system would help keep track of random urinalysis tests, he said.

After the hearing, FDA decided not to revoke Montefiore's program approval at the time, but the agency will verify the program's progress through regular reinspections.