Lessons lost by the global pharmaceutical
From the April 18, 2001 issue
Despite many frustrations with the slow resolution of some
product-related problems in the US, it is clear that practitioners'
efforts to report medication errors to the United States Pharmacopeia
(USP), ISMP and FDA have not been in vain. We have learned
much from practitioner reports, including evidence that a
large percentage of medication errors are attributable, at
least in part, to commercial labeling, packaging, and nomenclature
issues. As a result, the US pharmaceutical industry, USP,
and FDA have been given sufficient information upon which
to base improvements in labeling, packaging and naming of
pharmaceuticals aimed at reducing the risk of errors. However,
our recent interactions with ISMP Canada demonstrate that,
all too often, the pharmaceutical industry has failed to apply
many life-saving lessons learned in the US to the same products
used in other countries. This leaves patients throughout the
world at risk of harm from the very same problems that have
already been addressed in the US. Some examples:
· When LOSEC (omeprazole) was launched in 1989, it was often
confused with LASIX (furosemide). Scores of mix-ups and at
least two related deaths were reported. As a result, the brand
name was changed to PRILOSEC in the US. Yet, Losec remains
the brand name in other parts of the world, and in some countries
such as Canada, it is still being confused with Lasix.
· After a number of fatalities were reported from inadvertent
intrathecal injection of vincristine, USP and FDA issued requirements
for US manufacturers to visibly place a warning label on the
package. In addition, practitioners are required to place
a warning label, "FATAL if given intrathecally. FOR IV USE
ONLY," on extemporaneously prepared syringes. The syringe
must also be placed into an overwrap with this special warning,
which is supplied by the manufacturer. Yet, these label and
practice changes have not been required or made available
to practitioners in other countries, such as Canada or the
United Kingdom (UK), and fatalities in children and adults
continue to be reported. In one recently published editorial
related to a teenager's death in the UK (Berwick DM. Not again!
BMJ 2001;322:247-8) the author notes that 13 identical cases
of intrathecal vincristine have occurred in the UK since 1985.
· Recognizing that a 10-fold overdose may occur if the abbreviation
"U" (units) is mistakenly read as a zero, or if the decimal
point before a trailing zero is not seen, USP specifically
bans these designations on US product labels. Yet in Canada,
a manufacturer's container of insulin cartridges expresses
the concentration as "100U/mL, 3.0 mL cartridges."
· After numerous mix-ups between potassium chloride concentrate
and other medications, USP and FDA required US manufacturers
to package only potassium chloride concentrate vials with
a black cap, and to list clear warnings, "must be diluted"
on the cap, vial ferrule, and in a box on the front label
panel. In Canada, a plastic ampul of the concentrate contains
only a small black mark on the snap off portion. Labeling
requirements similar to those in the US are lacking.
· In Canada, vials of the neuromuscular blocking agent, QUELICIN
(succinylcholine), are devoid of any warning about it being
a paralyzing agent that causes respiratory arrest (therefore
requiring artificial ventilation when administered). In the
US, the vial cap and ferrule state, "Warning: paralyzing agent,"
and similar warnings appear on the front label panel.
If manufacturers and regulators of products used worldwide
fail to translate the lessons we've learned in the US into
the wider global market, is there any reason to believe that
the US is benefiting from lessons learned in other countries?
Are there ways for us to learn about label, package, and nomenclature
improvements made in other parts of the world? Are lessons
learned in other countries being translated into industry
actions here, or are we just waiting for accidents to happen
in the US in large enough numbers before taking action? While
so much of our improvement efforts have been reactive to date,
FDA and pharmaceutical manufacturers in the US are now beginning
to routinely analyze proposed brand names, labels, and packages
to determine error potential before product approval. Now,
it is time for global pharmaceutical industry leaders to understand
and give their full support to cooperative improvement efforts,
both reactive and proactive, which are implemented everywhere
products are used. Both ISMP Canada and ISMP Spain are committed
to working with ISMP (US) and facilitating this effort with
the pharmaceutical industry and regulatory agencies in their
respective countries. Despite language differences, the information
contained in a product's name, package, and label is universal
and must be clear for all pharmacists, physicians, nurses
and patients worldwide who must make decisions based on the