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

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From the May 1998 ACP Observer, copyright 1998 by the American College of Physicians.

FDA addresses worries about certain drug substitutions

In a recent letter, the FDA tried to assuage consumer fears over the growing trend of drug substitutions by explaining how bioequivalence is established between brand name drugs and their generic counterparts.

A number of advocacy groups have voiced concern as managed care organizations and state Medicaid programs increasingly substitute generic drugs in place of brand-name drugs. The concern has focused on a special class of prescription medications known as narrow therapeutic drugs (NTI), for which there is a very fine line between underdosing and overdosing.

The Health Alliance for NTI Patient Safety, which has gained the support of major medical organizations including the AMA, the American Psychiatric Association and the Epilepsy Foundation of America, has warned that the FDA standards for bioequivalence allow for too much variation between original brand name NTI drugs and generic NTI formulations. NTI drugs comprise about two dozen antiasthmatics, anticonvulsants, antiarrythmics, anticoagulants and antidepressants.

The Health Alliance for NTI Patient Safety is supported in part by DuPont Merck, the makers of Coumadin, a brand-name blood thinner for which a generic formulation, known as warfarin, has been released. It has publicized testimonials on the Internet from consumers who experienced complications such as seizures resulting from substitution of an NTI name-brand drug with a generic.

The FDA, however, stands by its claim that any therapeutically equivalent generic drug—NTI or not—that is identified in the FDA publication "Approved Drug Products with Therapeutic Equivalence Evaluations," otherwise known as the "Orange Book," is safe to substitute for the equivalent brand name.

The recent FDA letter on the matter, written by the associate commissioner for health affairs, Stuart K. Nightingale, MD, explained that products are tested to assure quality and interchangeability. The letter stated that NTI drugs might be subject to extra testing, depending on the complexity of the drug and on whether small changes in the dose or blood concentration could change how the drug affects patients.

Further, Dr. Nightingale stated that "there are no documented examples of a generic product manufactured to meet its approved specification that could not be used interchangeably with the corresponding brand-name drug." That includes NTI medications.

North Carolina, Texas and Virginia have passed laws forbidding pharmacies from substituting any NTI drug with a cheaper generic unless it's first approved by the physician and the patient.

As 'gatekeeping' grows, so do concerns

While gatekeeping has become a regular part of practice for both doctors and internists, a majority of Americans want a consumer protection law to require health plans to provide greater access to medical specialists—even if it means increased insurance premiums.

According to a study by the Washington-based Center for Studying Health System Change, 90% of internists and 94% of primary care physicians in group practices with more than three doctors serve as gatekeepers for at least some of their patients. Gatekeepers are defined as primary care doctors who control patients' access to specialists.

About 40% of internists' patients were in gatekeeping arrangements, according to the study. That percentage varied widely depending on the patient's type of insurance, with 46% of people with private insurance in gatekeeping arrangements, compared to 14% of Medicare beneficiaries.

A majority of Americans also say laws are needed to curb practices sometimes associated with gatekeeping. A study by the Henry J. Kaiser Family Foundation and Harvard School of Public Health found that 72% of the public supports laws that would guarantee consumer health care rights like those found in the "Consumer Bill of Rights," which was proposed by a presidential advisory commission last year. In the survey, 24% of the respondents said that they had experienced or knew of someone else having difficulty getting permission to see a medical specialist.

More than 80% of respondents in the second survey said they also favored a law that would provide greater access to medical specialists and would require health plans to allow women to see a gynecologist without preapproval. When told that such a law might increase health care premiums, the approval rating dropped to nearly 60%.

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