Off-label Prescribing Among Office-Based Physicians

Abstract

Background: Unlike medicines prescribed for Food and Drug Administration-approved indications, off-label uses may lack rigorous scientific scrutiny. Despite concerns about patient safety and costs to the health care system, little is known about the frequency of off-label drug use or the degree of scientific evidence supporting this practice. Methods:We used nationally representative data from the 2001 IMS Health National Disease and Therapeutic Index (NDTI) to define prescribing patterns by diagnosis for 160 commonly prescribed drugs. Each reported drug-diagnosis combination was identified as Food and Drug Administration-approved, off-label with strong scientific support, or off-label with limited or no scientific support. Outcome measures included (1) the proportion of uses that were off-label and (2) the proportion of off-label uses supported by strong scientific evidence. Multivariate analyses were used to identify drug-specific characteristics predictive of increased off-label use.Results: In 2001, there were an estimated 150 million (95% confidence interval, 127-173 million) off-label mentions (21% of overall use) among the sampled medications. Off-label use was most common among cardiac medications (46%, excluding antihyperlipidemic and antihypertensive agents) and anticonvulsants (46%), whereas gabapentin (83%) and amitriptyline hydrochloride (81%) had the greatest proportion of off-label use among specific medications. Most off-label drug mentions (73%; 95% confidence interval, 61%-84%) had little or no scientific support. Although several functional classes were associated with increased off-label use (PϽ.05), few other drug characteristics predicted off-label prescription.Conclusions: Off-label medication use is common in outpatient care, and most occurs without scientific support. Efforts should be made to scrutinize underevaluated off-label prescribing that compromises patient safety or represents wasteful medication use.

Critical evaluation of the off-label indication and of the risks associated to the use of multi-dose vials on the treatment of age-related macular degeneration

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‘Off-label’ drug use in sexual medicine treatment

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Drug utilization study of off-label drug use in outpatient department of psychiatry: a prospective study at a tertiary care teaching hospital

“…[4][5][6] The prescription of psychotropic drugs for management of psychiatric conditions across all age groups is rising worldwide. [7][8][9][10] Evidence showed that some antipsychotics are frequently prescribed as off-label for unapproved indication but only 4% of cases were supported by powerful clinical evidence. 9 Whereas, in India only two studies reported that the prevalence of prescribing off label drugs were 39.5% and 42.34% as per British National Formulary.…”

“…[7][8][9][10] Evidence showed that some antipsychotics are frequently prescribed as off-label for unapproved indication but only 4% of cases were supported by powerful clinical evidence. 9 Whereas, in India only two studies reported that the prevalence of prescribing off label drugs were 39.5% and 42.34% as per British National Formulary. 11,12 Through extensive literature review it was revealed that till date no such study is conducted in India as per National Formulary of India (NFI).…”