Publication:

Drug package inserts: how accessible is the information?

Background Information given in drug package inserts is often not easily accessible by patients and practitioners. Presentation of important information in an easily accessible manner fulfills the very purpose of inserts. In the present study, accessibility of important information in drug package inserts is evaluated.

Methods We evaluated 110 package inserts. Accessibility to important information was noted under following headings: use of box, use of special/bigger font or color, use of table of contents and information in front sheet. Each of these parameters was given a point. Cumulative accessibility score of more than three considered as accessible. Provision of toll free numbers and internet addresses of the companies noted.

Results Information in inserts regarding posology, method of administration, precautions under special conditions, contraindications, pharmacokinetics, interactions, pregnancy and lactation, driving, and machine use precautions were adequate and orderly in most. Only seven drug inserts mentioned important information with special font/different color. 18 drug inserts had used boxes. About 13 inserts used bigger font size for revealing important information. We observed a mean accessible score was 0.37 a insert. Only two inserts carried toll free numbers.

Conclusion Important information in drug package inserts is not easily accessible. Display of toll free numbers and internet addresses for queries and reporting adverse drug reactions is highly recommended.