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During the study period, a total of 72 patients met the inclusion criteria from the list of patients receiving drugs through the SAP; the parents of 65 patients (90%) consented to participation in the study. For the other 7 patients, the parents agreed to participate by telephone but did not return the written consent form by mail, despite two reminders. The files of 63 of the patients were obtained from the pharmacists after at most 2 follow-up contacts.

The patients were receiving a variety of drugs, the most common being cisapride (n = 25) and nitisinone (n = 10) (Table 1). The patients were divided about equally between the sexes (34 [52%] boys and 31 [48%] girls). Half of the patients were no more than 20 months of age when they started to take the unlicensed medication. Twenty-four (37%) of the patients were followed only by the physician who had prescribed the unlicensed drug, and 41 (63%) were followed by at least one other physician. Most of the patients (60 [92%]) had only one community pharmacist.
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Table 1. Method of Obtaining Unlicensed Medications through the Special Access Programme

Data concerning the types of physicians who prescribed the unlicensed medications and how these drugs were obtained are presented in Table 1. From the moment each patient started taking the unlicensed medication until the end of his or her participation in the study, the total duration of therapy was the equivalent of 1973 months. The mean duration of therapy (and standard deviation) with an unlicensed medication was30.4 ± 30.1 months. However, access to the community pharmacists’ files was available for a total of only 1351 months. Of that subset, 474 (35%) months of treatment involved unlicensed medications known to have level I, II, or III interactions (Table 2), and interactions actually occurred in 4 (0.8%) of those months (Table 2). These interactions occurred in a total of 3 patients, all of whom were taking cisapride. This represents 12% of the patients who used this medication, 8% of all patients who took a medication with known interactions, and 2% (4/243) of the total number of months during which cisapride was taken. Three (8%) of the 39 patients who took a medication with a known interaction were in fact exposed to a potential drug interaction.
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Table 2. Potential Drug Interactions Detected

The potential interactions detected involved cisapride and either erythromycin, clarithromycin, or amitriptyline. Interactions between cisapride and either erythromycin or clarithromycin are considered major. Such interactions are caused by inhibition of the metabolism of cisapride by each antibiotic; this could in turn increase the plasma concentration of cisapride and the potential for toxic manifestations such as arrhythmias. The interaction between cisapride and amitriptyline is classified as a level I interaction in Drug Interaction Facts and is judged as major in Micromedex MD. The risk associated with the latter interaction would be due to the potential additive increase in QT interval from the combination of the two agents. The 3 cases of potential interactions observed in this study are described briefly here.
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