Survey of safety and efficacy information in drug inserts for topical prescription medications.
OBJECTIVE
Drug inserts are an important source of information for patients and physicians regarding the safety and proper administration of a drug. However, recent studies have found that inserts are still missing key information regarding a drug's safety and efficacy. The aim of this study was to ascertain whether inserts in US-sold topical prescription drugs are deficient with respect to key safety and efficacy information required by the US FDA.


METHODS
We evaluated the inserts of 15 topical prescription medications sold in the US against a set of 14 safety criteria based on FDA requirements.


RESULTS
Inserts were deficient in several key safety categories for patients, including information regarding pregnancy, nursing women, and pediatric and geriatric patients. Additionally, in a majority of inserts, information was not provided on how to deal with an administrative error made when attempting to apply a drug.


CONCLUSIONS
To improve drug inserts the industry must address these deficiencies as well as implement a safety index for nursing, pediatric, and geriatric patients detailing how dangerous the drug can be to these populations depending on available animal or human studies. Companies should also provide contact information for a dermatologist on staff who can provide answers to safety questions when these are not clearly detailed in the insert.
Zaghi
Danny
D
Department of Dermatology, School of Medicine, University of California San Francisco, San Francisco, CA 94143, USA.
Maibach
Howard I
HI
D000287:Administration, Topical; D004348:Drug Labeling / Q000592:standards*; D011307:Drug Prescriptions; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D033181:Information Dissemination; D010353:Patient Education as Topic; D014481:United States; D014486:United States Food and Drug Administration