A new study has shown that the continued promotion of off-label drug uses by pharmaceutical representatives can influence physicians to prescribe medicines for unapproved uses, sometimes with adverse consequences for the patient.
Pharmaceutical companies are prohibited by law from marketing a drug for any use other than what is listed on the label – uses approved by the Food and Drug Administration (FDA) – but a physician is permitted to prescribe an approved drug for any use he or she deems appropriate. Since many drugs can be used to treat diseases other than those listed, physicians do write “off-label” prescriptions. Research published in the journal Health Affairs, however, shows that some drug companies, despite the restrictions, encourage off-label prescribing through the process known as “detailing”: the direct promoting of drugs to physicians by pharmaceutical sales reps, Triangle Business Journal reports.
According to the article’s authors, “Pharmaceutical industry marketing has been shown to affect physician prescribing in favor of the promoted product, even if that use is not supported by the totality of the evidence.” The authors note that off-label prescribing can have benefits if it is “based on solid data… However, it carries the risk that patients will be exposed to uncertain benefits and the prospect of serious adverse effects,” Triangle Business Journal reports. The study looked at prescribing of antidepressant and antipsychotic drugs to children, a controversial area because of limited evidence for their use in this population.
Pharmaceutical company GlaxoSmithKline recently reached a $105 million settlement over allegations that it improperly marketed drugs including the asthma drug Advair (fluticasone/salmeterol), according to Triangle Business Journal. Other drug makers face fines or settlements.
The authors do not advocate complete abandonment of off-label prescribing, but they encourage hospital systems, doctors, and patients to be careful about drugs that are prescribed for off-label uses, according to Triangle Business Journal.