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International Journal for Quality in Health Care Advance Access published online on March 12, 2008
International Journal for Quality in Health Care, doi:10.1093/intqhc/mzn001
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© The Author 2008. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved

Conformity of commercial oral single solid unit dose packages in hospital pharmacy practice

Maxime Thibault, Sonia Prot-Labarthe, Jean-François Bussières and Denis Lebel

Department of Pharmacy, Unité de Recherche en Pratique Pharmaceutique, Centre Hospitalier Universitaire Sainte-Justine, Montréal, Québec, Canada

Background. There are limited published data on the labelling of single unit dose packages in hospitals.

Setting and participants. The study was conducted in three large hospitals (two adult and one paediatric) in the metropolitan Montreal area, Quebec, Canada.

Objective. The objective is to evaluate the labelling of commercial oral single solid unit dose packages available in Canadian urban hospital pharmacy practice.

Method. The study endpoint was the labelling conformity of each unit dose package for each criterion and overall for each manufacturer. Complete labelling of unit dose packages should include the following information: (1) brand name, (2) international non-proprietary name or generic name, (3) dosage, (4) pharmaceutical form, (5) manufacturer's name, (6) expiry date, (7) batch number and (8) drug identification number. We also evaluated the ease with which a single unit dose package is detached from a multiple unit dose package for quick, easy and safe use by pharmacy staff. Conformity levels were compared between brand-name and generic packages.

Results. A total of 124 different unit dose packages were evaluated. The level of conformity of each criterion varied between 19 and 50%. Only 43% of unit dose packages provided an easy-to-detach system for single doses. Among the 14 manufacturers with three or more unit dose packages evaluated, eight (57%) had a conformity level less than 50%.

Conclusion. This study describes the conformity of commercial oral single solid unit dose packages in hospital pharmacy practice in Quebec. A large proportion of unit dose packages do not conform to a set of nine criteria set out in the guidelines of the American Society of Health-System Pharmacists and the Canadian Society of Hospital Pharmacists.

Keywords: blister packaging, bulk, drug packaging and labeling, unit dose package

Address reprint requests to: Jean-François Bussières; Department of Pharmacy, Unité de Recherche en Pratique Pharmaceutique, Centre Hospitalier Universitaire Sainte-Justine, Montréal, Québec, Canada. E-mail: jf.bussieres{at}ssss.gouv.qc.ca

Accepted for publication January 25, 2008.


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