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Lessons lost by the global pharmaceutical industry



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 information presented.

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