THE VIRGINIAN-PILOT
Copyright (c) 1997, Landmark Communications, Inc.
DATE: Wednesday, February 19, 1997 TAG: 9702190004
SECTION: FRONT PAGE: A12 EDITION: FINAL
TYPE: OPINION
SOURCE: BY JAMES S. TODD, M.D.
LENGTH: 84 lines
The Virginia Senate is currently considering legislation, already passed by the House of Delegates, which would make an essential change in the laws governing the use of prescription medications in the commonwealth. This change will help eliminate a potential threat to the health and safety of Virginia citizens who are currently or may in the future be taking one or more of a small group of medicines known as narrow therapeutic index, or NTI, drugs.
Of the many thousands of prescription drugs in use today, only about two dozen have been classified by the U.S. Food and Drug Administration (FDA) as having a narrow therapeutic index, sometimes also known as a narrow therapeutic range.
The narrow therapeutic index designation refers to the need to make sure patients using NTI drugs are receiving exactly the amount of the drug they need for treatment of their medical condition. Too little of an NTI drug in a patient's bloodstream results in a lack of effectiveness, too much may result in toxic effects, literally threatening the patient's health.
When patients are first prescribed an NTI drug, they normally go through an intensive period of monitoring to make sure they are receiving the precise amount of the drug necessary for treatment - that the drug is in the narrow therapeutic range for that drug in that patient. Once a patient has been ``stabilized'' on the NTI drug, he or she continues to be monitored on a regular basis to make sure the blood level of the drug remains in the therapeutic range.
One important concern about the use of NTI drugs centers on the issue of the substitution of different formulations of the same drug, an increasingly common practice because of the push to help control prescription-drug costs through the use of less-costly ``generic'' drug formulations.
When a new drug is approved by the FDA and introduced into the marketplace, the manufacturer of the drug is usually granted protection from imitators by patent laws. This allows the manufacturer to recoup some of the research-and-development costs incurred in discovering and developing drugs. After several years, however, the manufacturer of the original (often called ``innovator'') drug loses patent protection and is subject to competition from other manufacturers who may produce ``generic'' formulations of the medication.
There is nothing fundamentally wrong with this system. Generic formulations of prescription drugs have a legitimate role in helping bring down the costs of health care by introducing competition to the marketplace.
While the FDA has recognized the special nature of NTI drugs for more than 15 years, the agency has not established a stricter bioequivalency standard for generic formulations of NTI drugs. The current process the FDA uses to evaluate a generic formulation of an existing drug may not assure that the new formulation will have exactly the same effect in an individual patient as the original formulation.
In the case of most prescriptions, substitution of generic formulations is usually not a problem. In the case of NTI drugs, however, there is growing concern that such substitution of formulations may indeed cause a problem for the patient. The potential problem with changing a patient from one formulation of an NTI drug to another without the knowledge of the patient or the physician is that it is possible the new formulation may not have exactly the same effect in the patient's bloodstream.
Under current Virginia law, it is entirely possible one of my patients could receive a new formulation of an NTI drug without my knowledge or their knowledge. In this case, I would be unable to make sure the patient went through the monitoring needed to make sure he or she was properly stabilized on the new formulation.
The legislation currently being considered by the Senate will ensure that formulations of NTI drugs are never interchanged without the knowledge and approval of both the patient taking the drug and the physician who prescribed it. This legislation does not favor any pharmaceutical company or any drug formulation over another. It is purely a patient-safety measure, protecting patients who take both branded and generic drug formulations.
With the many important pieces of legislation before the General Assembly, it may be easy to fail to recognize the importance of this legislation to so many Virginians. The Virginia General Assembly currently has the opportunity to establish the commonwealth as a leader in establishing important safeguards designed to protect the health and safety of thousands of our citizens who take NTI drugs. MEMO: James S. Todd, M.D., of Ridgewood, N.J., is a retired physician
and immediate past executive vice president of the American Medical
Association. He is on the advisory committee of the Health Alliance for
NTI Patient Safety, a national coalition dedicated to safeguarding the
interest of patients taking narrow therapeutic index drugs. He
testified recently before the Virginia House of Delegates.