Magazine article Drug Topics

Noncompliance Data and Clinical Outcomes: Impact on Health Care

Magazine article Drug Topics

Noncompliance Data and Clinical Outcomes: Impact on Health Care

Article excerpt

The failure of patients to take drugs as prescribed has been thoroughly documented, and many health care proffesionals are aware of the implications of noncompliance. That the matter of compliance remains relatively neglected by regulatory agencies, physicians, and many drug manufacturers is therefore of concern to health care professionals.

Noncompliance occurs for myriad reasons and may be difficult to explain in a given patient. At one extreme is the rare patient who is totally noncompliant--who never fills a prescription or who fills the prescription but never takes the drug--and at the other is the one who never forgets a dose. Most patients intend to comply but fail to do so for various reasons.

WHY PATIENTS FAIL TO COMPLY

A chief reason that many patients are not compliant is that they simply forget to take their medication. As the elderly memory impairment becomes more widespread, forgetfulness is becoming an increasingly significant factor. The problem is compounded by the fact that many elderly persons do not have regular caregivers. Furthermore, the elderly have more medical problems and therefore take more medications.

Some patients fail to comply with their treatment regimen because they have not understood the physician's instructions. Physicians should confirm that their patients have understood their instructions, provide written explanations when necessary, and stress the need for compliance and relate the implications of noncompliance.

Patients may stop taking medication because of intolerable side effects. It is difficult to predict which patients will have a real or perceived adverse reaction to a particular drug, but it may be helpful to discuss the possibility of adverse reactions to assure patients that in most cases the reaction can be alleviated by adjusting the dosage or changing medications. For the issue of side effects to be addressed effectively, however, patients must be truthful when telling physicians about their degree of compliance.

A perception exists that the elderly are at increased risk for adverse medication effects. However, I believe that if one stratified the general population by age, severity of disease, type of disease, and number of medications, a greater overall incidence of side effects among the elderly would not be observed.

Some patients exhibit "intelligent" noncompliance. For example, serum digoxin levels were measured in patients whose care was being supervised by a group of competent cardiologists and internists at a major teaching hospital. The physicians believed that digitalis had been titrated to appropriate levels. The results of serum assays, however, showed that many of the patients had very low or unmeasurable serum digoxin levels. Presumably, the patients had discovered over time that when they stopped taking their medication, they did not feel any worse. Possibly the greatest challenge in encouraging compliance is to overcome a patient's lack of incentive to adhere to a treatment whose goal is prevention of some future harm.

THE ROLE OF NONCOMPLIANCE IN THE DRUG APPROVAL PROCESS

Noncompliance affects the evaluation and approval of new pharmaceutical agents at two stages: during clinical investigation, which precedes drug approval and marketing, and at the post-approval stage, when some manifestations of compliance become apparent because the drug has begun to see general use and the number of patients on the medication increases.

PREAPPROVAL

Some approval delays probably can be attributed to noncompliance and the failure of investigators to recognize it. Difficulty in demonstrating a drug's efficacy may relate to the requirement of the Food and Drug Administration (FDA) that studies employ an "intent-to-treat" analysis, which assumes that patients follow the regimen to which they are assigned. Noncompliance may interfere with the determination of the most effective dosing schedule. …

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