Measuring compliance of package inserts in the Emirate of Abu Dhabi—UAE

Hadaya Gharibyar, Yasser Sharif, Sherif El Ghandour, Maysoon Saffarini, Bashir Aden

Health Authority—Abu Dhabi, Abu Dhabi, UAE.
Health Authority—Abu Dhabi, Abu Dhabi, UAE;.
Section Head Medication & Medical Products Safety, Health Authority—Abu Dhabi, Abu Dhabi, UAE.

DOI: 10.4236/health.2013.55110                

Abstract

Purpose: The aim of this study was to examine if package inserts (PIs) supplied with prescribed medications in the Emirate of Abu Dhabi contain all relevant information to the safe and appropriate use of these medications. Methods: Sixty seven PIs for prescription—only medications were evaluated against a set of safety criteria published from the Ministry of Health. Results: Analyzed PIs showed many deficiencies with regard to the Ministry of Health (MOH) Investigation New Drug Application (INDA) requirements. Particularly of concern were side effects, warnings, use in pregnancy, lactation, and the storage conditions for the product. Conclusions: This study indicated that information relevant to the safe and appropriate use of medications was not uniformly mentioned in the PIs analyzed. To avoid medication errors due to deficits in the current PIs, we recommend regulatory oversight and regulator audits from pharmaceutical company, followed by enhancement of regulations requiring companies to also create patient information leaflets.

Keywords

Drug Labeling; Generic Medications; Adverse Reactions; Drug Safety; Pharmacoepidemiology; Drug Information; Abu Dhabi; UAE; Package Inserts

Conflicts of Interest

The authors declare no conflicts of interest.

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