Proposed Curbs on Some Prescription Drugs Anger Doctors, Pharmacists

Tighter prescription controls proposed for some powerful drugs, including popular medications for anxiety and sleep disorders, have some lawmakers at odds with medical and pharmaceutical groups.

Increased government scrutiny of dispensing certain drugs will help reduce abuse and illegal use, authors of several bills contend. But doctors, pharmacists and drug companies say the tighter regulations would make it harder for people who legitimately need medication to obtain it.

Much of the controversy surrounds the benzodiazepine class of drugs, which include the sleep-inducing drugs Halcion and Dalmane and the tranquilizers Xanax and Valium. Such medications slow the central nervous system and are used to relieve short-term nervousness and tension, and to treat insomnia. Particular medications within the benzodiazepine class also are used to treat muscle spasms and some convulsive disorders, such as epilepsy.

The law requires that controlled substances must be “scheduled” according to what is known about their potential for abuse. For example, Schedule I drugs (such as opium) have the highest abuse potential and the strictest controls; Schedule V drugs have the lowest such potential and restrictions.

Some politicians say they want to reduce abuse of the benzodiazepines, which by some accounts constitutes one-fourth of drug arrests and emergency-room admissions.

In California, Assemblywoman Jackie Speier (D-South San Francisco) has introduced legislation that would move benzodiazepines from Schedule IV to Schedule III.

“While there may be good associated with some of the estimated 10 million benzo prescriptions written in California each year, there is also pain and suffering associated with its misuse,” Speier said in introducing the bills on March 6. “Benzodiazepines are not benign drugs. Consumer awareness must be heightened about these prescription drugs.”

If benzodiazepines were moved from Schedule IV to III, physicians would have to write prescriptions by hand. Doctors prescribing Schedule IV drugs can use convenient, pre-printed forms and only have to sign their name and, if needed, the dosage.

An even farther-reaching bill will be introduced in Congress by Rep. Pete Stark (D-Oakland) later this spring. It would require triplicate prescription forms for drugs in schedules II through V, with one copy sent to a government agency to monitor abuse.

But many physicians say accusations that benzodiazepines are over-prescribed and misused are exaggerated, and several medical and psychiatric groups, drug manufacturers and pharmacists’ organizations oppose rescheduling.

According to a statement released in January by an advocacy group, the Committee For Responsible Use of Psychiatric Medication, tighter regulations would:

* Limit medication access for patients with legitimate disorders.

* Lead physicians to substitute drugs that are less safe and effective.

* Destroy patient confidentiality.

* Increase costs because of repeated physician and pharmacist visits for each refill.

* Increase the stigma associated with mental illness.

Dr. Dennis Munjack, of the anxiety disorders clinic at the University of Southern California, says benzodiazepine abuse is not as prevalent as some lawmakers suggest: “There is very clear evidence that people who abuse benzodiazepines abuse everything. In our studies and follow-up studies, people end up taking less medication than more. We are selecting people (for the medication) with no history of drug abuse.”

Only one state, New York, has implemented triplicate prescriptions for benzodiazepines. State health department officials there estimate that benzodiazepine prescriptions have fallen 50% and say illegal street use has disappeared since the regulation went into effect on Jan. 1, 1989.

“That (illegal use) certainly went down,” says Christopher Delker, associate director of New York’s division of public health protection. “But that was not our main purpose. Our concern was that these drugs were being prescribed for longer than necessary even when the initial diagnosis was necessary.”