Healthy Skepticism Library item: 9819

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Zaghi D, Maibach HI.
Survey of safety and efficacy information in drug inserts for topical prescription medications.
Am J Clin Dermatol 2007; 8:(1):43-6
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17298106&query_hl=19&itool=pubmed_DocSum

Abstract:

BACKGROUND AND 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.

METHOD: 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.

CONCLUSION: 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.

Keywords:
Publication Types: Evaluation Studies MeSH Terms: Administration, Topical Drug Labeling/standards* Drug Toxicity Humans Information Dissemination Patient Education Pharmaceutical Preparations/adverse effects* Prescriptions, Drug* United States United States Food and Drug Administration Substances: Pharmaceutical Preparations