Collection of medical drug information in pharmacies: Drug Event Monitoring (DEM) in Japan

To establish a system for collecting and reporting information from community pharmacists such as that on adverse effects, the Japan Pharmaceutical Association (JPA) conducts Drug Event Monitoring (DEM). In the fiscal year 2002, a survey was carried out to clarify the incidence of sleepiness due to antiallergic drugs. The investigated active ingredients were ebastine, fexofenadine hydrochloride, cetirizine hydrochloride, and loratadine. Community pharmacists asked the following question to patients who visited their pharmacies: "Have you ever become sleepy after taking this drug?" During a 4-week survey period, reports of 94256 cases were collected. To evaluate the incidence of sleepiness, we analyzed cases in which reports showed alleged absence of concomitant oral drugs, and drug use in conformity with the dose and method described in package inserts. The incidence of sleepiness was significantly different among the drugs (chi(2)-test, p<0.001). The observed incidences of sleepiness due to the drugs (8.8-20.5%) were higher than those described in each package insert (1.8-6.35%). This may be because an active question was used ("Have you ever become sleepy after taking this drug?"). Active intervention by pharmacists may be useful for collecting more information on improvement in the QOL of patients and safety. In addition, the pharmacists were asked to report events other than "sleepiness" in the free description column of the report. Some symptoms not described in the package inserts were reported, suggesting that DEM may lead to the discovery of new adverse effects. These results suggest that community pharmacists have a good opportunity to collect information in DEM, and safety information such as that on adverse effects can be obtained from pharmacies.