Drug packaging
Online posting: February 13, 1997
Published in print: Mar. 15, 1997 (CMAJ 1997;156:764)
Re: Over the counter and into trouble, by Dr. Catherine Younger-
Lewis, CMAJ 1997;156:17 [letter]
See also: Action long overdue on drug labelling, N.A. Rosen
The letter on drug-labelling confusion by Dr. Younger-Lewis made
me wonder how a human-factors consultant might approach this
problem.
May I offer 10 drug-delivery principles that I think apply?
1. Labelling
Package labelling should be clear and unambiguous, with
readable fonts and sharp print contrast.
2. Warnings
Special instructions or warnings should be highlighted and
prominently displayed on the packaging (e.g., May be sedating —
avoid operating heavy machinery).
3. Product identifiability
All products should have a product code, lot number, expiry
date and suggested route of administration. In addition, tablets
should have unique markings to allow product recognition.
4. Generic name
The generic (scientific) name of the drug should be
prominently displayed on the drug label.
5. Trade name
The drug trade name, if displayed, should not be expected to
result in drug misidentification.
6. Dose
For tablets and other oral forms, the dose of each tablet
should be clearly stated (not necessarily as markings on the
tablet). Tablets should be marked with a unique identifier.
7. Concentration
Labels for drugs in liquid form should clearly indicate the
concentration and volume.
8. Strength
On the label, the strength of the product should be
predominant over the number of units in the package.
9. Safety
The drug packaging should not present a safety hazard to
users (e.g., glass ampoules that completely disintegrate when
opened).
10. Special needs
Users with special needs, such as children, patients with
limited vision and patients with arthritis, should be taken into
consideration.
The problems discovered by Younger-Lewis appear to be a
serious violation of principle 5.
John Doyle, MD, PhD
Toronto Hospital
University of Toronto
Toronto, Ont.
djdoyle@compuserve.com
http://doyle.ibme.utoronto.c
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