American College of Physicians: Internal Medicine — Doctors for Adults ®


FDA news

From the December 1997 ACP Observer, copyright 1997 by the American College of Physicians.

Wanted: reports of therapeutic switching

If you have a patient who was hurt when a managed care company or pharmacy benefit manager changed the drug you had prescribed for that person, the FDA wants to hear from you.

A number of consumer groups and pharmaceutical companies have asked the agency to write regulations that address the practice of "therapeutic switching," but the FDA has received few reports that this is a widespread problem. A therapeutic switch occurs when a totally different drug is substituted for a prescribed drug.

Therapeutic switching is becoming more common, according to the FDA, as pharmacy benefit management companies institute programs to reduce the drug costs to insurers. While most states require all switches in drugs to be approved by the doctor, there are some concerns that physicians feel pressured to authorize a switch.

"The problem is that we have gotten so few reports that we cannot draw any conclusions," said Laurie Burke, senior regulatory research officer with the agency. "If there is a real patient risk associated with these activities, that would be something we would address in terms of our regulation of prescription drug promotion."

One adverse reaction the FDA did hear about, Ms. Burke said, involved a diabetic with hypercholesteremia. When the patient's cholesterol-lowering drug was switched, his blood sugar went out of control.

Some of the concern about therapeutic switching grows out of the fact that three of the largest pharmacy benefits management companies were acquired in the last few years by three of the largest pharmaceutical companies, Ms. Burke said.

Therapeutic switching raises more concern than switching prescriptions to generics because generic products have mostly been proved to be bioequivalent, she said. In the case of therapeutic switches, however, the drugs are not always the same chemically.

Any health professional who is aware of any adverse consequences of therapeutic switches should report them through the FDA's MedWatch program. Information: 800-FDA-1088.

Who's spending the big bucks?

Guess the medical condition that was the subject of the fastest-growing direct-to-consumer drug advertising campaign last year.

If you said osteoporosis, thinking of Merck's Fosamax campaign, you were right. According to the latest report from Scott-Levin, a Pennsylvania-based pharmaceutical consulting firm, pharmaceutical companies spent $600 million on direct-to-consumer advertising of prescription products in 1996, up 56% from the previous year. In the first half of 1997, the report found, the companies spent about $450 million on drugs ads for consumers.

The top 10 drugs advertised directly to consumers in 1996 were Claritin, Zocor, Sporanox, Flonase, Zyrtec, Fosamax, Pravachol, Imitrex, Allegra and Prempro.

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