Prescription off-label Drug
The direct promotion of off-label drug uses direct promotion of off-label drug uses by pharmaceutical sales representatives can influence physicians to prescribe medicines for unapproved uses, sometimes with adverse consequences for patients, a new study reports.
Research published in the journal Health Affairs shows that some drug companies 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. Pharmaceutical companies are prohibited by law from labeling or marketing a drug for any use other than what has been approved by the Food and Drug Administration (FDA), but a physician may prescribe an approved drug for any use the doctor deems appropriate. Many drugs can be used to treat diseases other than those listed on the label, and physicians write off-label prescriptions, especially where other drugs have failed to help the patient.
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.” Off-label prescribing can have benefits, the authors write, but “it carries the risk that patients will be exposed to uncertain benefits and the prospect of serious adverse effects,” Triangle Business Journal reports. The Health Affairs study looked at the prescribing of antidepressant and antipsychotic drugs to children, a controversial area because “it includes substantial prescribing of drugs for uses that have not been approved by the Food and Drug Administration (“off label”) and are not evidence based,” the authors explain in the article’s abstract.
A number of pharmaceutical companies have faced fines or lawsuits over adverse effects of off-label use of these medications in children. GlaxoSmithKline, accused of improperly marketing drugs including the asthma drug Advair (fluticasone/salmeterol), agreed to a $105 million dollar settlement, according to Triangle Business Journal.
The authors do not advocate abandoning off-label prescribing, but they urge hospital systems, doctors, and patients, to be cautious about off-label prescriptions, according to Triangle Business Journal.