TITLE:
Measuring compliance of package inserts in the Emirate of Abu Dhabi—UAE
AUTHORS:
Hadaya Gharibyar, Yasser Sharif, Sherif El Ghandour, Maysoon Saffarini, Bashir Aden
KEYWORDS:
Drug Labeling; Generic Medications; Adverse Reactions; Drug Safety; Pharmacoepidemiology; Drug Information; Abu Dhabi; UAE; Package Inserts
JOURNAL NAME:
Health,
Vol.5 No.5,
May
27,
2013
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.