english.prescrire.org > Annual Prescrire Awards > The Prescrire Awards for 2010 > The 2010 Prescrire Awards: chosen in all independence by Prescrire's Editorial staff > Prescrire's annual review of drug packaging in 2010 > Editors' opinion: Regulatory agencies and companies must take packaging more seriously

The Prescrire Awards for 2010

The 2010 Prescrire Awards: chosen in all independence by Prescrire's Editorial staff

Prescrire's annual review of drug packaging in 2010
Editors' opinion: Regulatory agencies and companies must take packaging more seriously

Everything that is needed to produce safe and convenient drug packaging is already available on the market, yet the quality of most packaging remains mediocre. As a result, some products carry a risk of potentially dangerous medication errors.

Guidelines needed
Guidelines are needed for packaging safety, including: quality criteria for unit-dose packaging; the design of dosing devices; safety guidelines for dangerous substances; careful use of colour on the labelling in order to distinguish between different dose strengths belonging to the same product line; specific recommendations for paediatric drug packaging; and key information for patients, according to the nature of the medication, its indications, route of administration, pharmaceutical form, and devices for preparation and administration.

Existing guidelines tend to focus on administrative requirements and cost rather than on the quality of patient care. For example, European recommendations on the expression of drug concentrations and dose strengths exist solely for administrative purposes, not to help health professionals and patients use drugs correctly (1).

More stringent controls
Some drugs with dangerous packaging still reach the market despite controls put in place by European or national regulatory authorities and pharmacovigilance committees. The French Transparency committee is supposed to weigh the advantages and disadvantages of new drugs relative to existing products; this includes the packaging. Ineffective controls create an unacceptable risk of confusion and medication errors in practice.

Making drug packaging safer and more convenient to use is a means of improving the quality of health care. Regulatory agencies and drug companies must take this issue more seriously. 

©Prescrire 1 June 2011

"2010 drug packaging review: identifying problems to prevent errors" Prescrire Int 2011; 20 (117): 162-165. (pdf, free)

Reference:
1- European Medicines Agency “QRD Recommendations on the expression of strength in the name of centrally authorised human medicinal products” 18 November 2009 + “Submission of comments - Comments from International Medication Safety Network” 28 May 2009: 5 + 9 pages.