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.
Cite this paper
Gharibyar, H. , Sharif, Y. , Ghandour, S. , Saffarini, M. and Aden, B. (2013) Measuring compliance of package inserts in the Emirate of Abu Dhabi—UAE. Health
, 834-837. doi: 10.4236/health.2013.55110
 Joubert, P.H. and Skene, D. (1984) Attitudes of private medical practitioners towards package inserts and other drug information sources. South Africa Medical Journal, 66, 306-307.
 Fuchs, J., Hippius, M. and Schaefer, M. (2005) A survey of package inserts use by patients. Hospital Pharmacy Europe, 21, 29-31.
 Shivkar, Y.M. (2009) Clinical information in drug package inserts in India. Journal of Post Graduate Medicine, 55, 104-107. doi:10.4103/0022-3859.52840
 European Medicines Agency (2008) Guideline on the packaging information of medicinal products for human use. http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-2/c/bluebox_02_2008.pdf
 Food and Drug Administration (2006) Requirements on content and format of labeling for human prescription drug and biological products. Federal Register, 71, 3922-3997.
 Raynor, D.K., Svarstad, B., Knapp, P., et al. (2007) Consumer medication information in the United States, Europe, and Australia: A comparative evaluation. Journal of the American Pharmacists Association, 47, 717-724.
 Raynor, D.K., Blenkinsopp, A., Knapp, P., et al. (2007) A systematic review of quantitative and qualitative research on the role and effectiveness of written information available to patients about individual medicines. Health Technology Assessment, 11, 1-160.
 Gharibyar, H., Sharif, Y., Al Qawasme, K. and Fahmy, S. (2012) Physicians’ perception of drug information resources in the emirate of Abu Dhabi—UAE. Pharmacology & Pharmacy, 52-56.
 Gharibyar, H. and Sharif, Y. (2012) Evaluation of pharmaceutical drug information brochures in the emirate of Abu Dhabi (United Arab Emirates). Journal of Pharmaceutical Health Services Research, 3, 57-62.
 Health Authority—Abu Dhabi (2011) Health statistics.
 Ministry of Health (2012) Investigation new drug application. www.moh.gov.ae/en/
 Bawazir, S.A., Al-Hassan, M.I., Al-Khamis, K.I., Abou-Auda, H.S. and Gubara, O.A. (1991) Comparative study of Saudi-marketed products and US drug labeling. DICP, 25, 863-866.
 Al-Aqeel, S.A. (2012) Evaluation of medication package inserts in Saudi Arabia. Drug, Healthcare and Patient Safety, 4, 33-38. doi:10.2147/DHPS.S29402
 Duke, J., Friedlin, J. and Li, X. (2012) Consistency in the safety labeling of bioequivalent medications. Pharmacoepidemiology and Drug Safety, 22, 294-301.