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To the Editor.—
Prescribing and dosing errors (including administration of 10 times or one 10th of the correct dose) have long been recognized as a source of serious concern in pediatrics, where they frequently can be life-threatening.1–3 We wish to draw attention to an insidious form of medication error that can occur at the pharmacy dispensing stage, which to the best of our knowledge has hitherto gone unreported: the provision of paper packets containing incorrect dosages of powder obtained from crushed tablets.
Our direct experience regards 2 newborns receiving outpatient treatment (in 2002) with oral flecainide for the treatment of clinically severe paroxysmal supraventricular tachycardia. In both patients, clinically important dosing errors were uncovered after serum flecainide dosing4: serum flecainide concentrations were below the therapeutic range (90 and 110 ng/mL, respectively, with the therapeutic range being 200–600 ng/mL). In both cases, we found that each of the paper packets of crushed powder yielded <6 mg (instead of the required 15 mg) of the active principle, flecainide acetate. Given the relatively narrow therapeutic window of the drug, such a discrepancy can put infants’ lives at risk. Indeed, in 1 of our patients, the problem was discovered after a severe recurrence of supraventricular tachycardia with clear signs of low cardiac output. In the other patient, the error was unmasked by an early serum flecainide dosing, highlighting the importance of close monitoring during such delicate therapeutic situations.4
One of the pharmacists in question freely admitted how the mistake had happened. After crushing a tablet weighing 265 mg, containing 100 mg of flecainide acetate, he had prepared paper packets containing 15 mg of the powder instead of 15 mg of the active ingredient, as had been clearly indicated on the prescription form. Struck by the similarity of the 2 incidents and by the fact that the 2 sets of packets had been made up independently in 2 separate pharmacies, we decided to investigate the possible incidence of such occurrences in our region. We therefore sent similar, clearly worded prescriptions to 17 different pharmacies in 5 different towns. Two additional, identical errors occurred (in different towns), suggesting that this particular prescribing modality might be associated with a risk of error as high as 10%.
The clinical relevance of such mistakes suggests the need to identify and prevent possible sources of medication error at the pharmacy dispensing stage. How could this particular problem be solved? In some countries, life-saving and other important drugs used in a pediatric setting are available on request from local pharmacies in solution form. Such a strategy might provide a simple solution to this "crushing" problem. In the meantime, pharmacists should be made aware of the importance of avoiding this elementary, but apparently not so infrequent, blunder.
ACKNOWLEDGMENTS
We dedicate this report to Francesco Bronzetti, who paid advanced prenatal visits to the pharmacies with his mother, A.C.
REFERENCES
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