Intensive monitoring of new drugs based on first prescription signals from pharmacists: a pilot study.
BACKGROUND
Intensive monitoring can be a valuable tool in the early detection of adverse drug reactions, especially of new drugs. Aim of this pilot study was to investigate the practical possibilities of a system of intensive monitoring, using the pharmacy computer system to detect the first dispensing of a new drug.


METHODS
Eight pharmacists were asked to monitor, using their computer system, when a general practitioner prescribed the target drug (rofecoxib). The pharmacists were also requested to provide the researchers at Lareb with an overview of the patient's medication history. Subsequently, the pharmacist sent the prescribing physician an envelope containing information about the project and a reporting form (all provided by Lareb), which the GP was requested to return to Lareb after the next visit of the patient. The items on the questionnaire concerned characteristics of the patient (anonymous), indication, dose and information about possible adverse drug reactions.


RESULTS
During a 4-week period, the participating pharmacists signalled 44 first prescriptions of rofecoxib. For each of these signals, the pharmacist provided Lareb with the medication history of the patient involved. Of the prescribing GPs who had been sent the report form, 70.5% (n = 31) returned the form. Twenty-one of the 31 forms were returned within 4 weeks. The medication histories showed that in 43 of the 44 cases, the dispensing of the target drug was indeed the first delivery. The participating pharmacists and GPs were also sent an evaluation form. All pharmacists returned their evaluations, indicating an overall motivation to participate in the proposed system. In total, seven GPs returned their evaluation forms, three of whom had not reported adverse drug events to the national spontaneous reporting centre before.


CONCLUSIONS
Although the number of participants in this trial was small, we conclude that pharmacists and prescribing physicians are able and willing to contribute to an intensive monitoring system for new drugs.
D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D016861:Cyclooxygenase Inhibitors / Q000009:adverse effects; D011307:Drug Prescriptions; D006801:Humans; D007783:Lactones / Q000009:adverse effects; D010595:Pharmacists; D010865:Pilot Projects; D013450:Sulfones
D016861:Cyclooxygenase Inhibitors; D007783:Lactones; D013450:Sulfones; C116926:rofecoxib