Objective : We studied the effective utilization of the community pharmacy-based prescription data for the event monitoring system in Japan, and attempted to evaluate the association between symptoms suspected of adverse drug reactions (ADRS) and the drug, inorder to improve the quality of ADR reports.
Methods : 1) The community pharmacy-based prescription data obtained from 98 patients to whom medicines were dispensed in a community pharmacy, were examined to select subjects who had discontinued drug treatment and to evaluate outcome after the discontinuation.2) In the cases who discontinued treatment, risk information (for example, timing from the onset of therapyto the appearance of symptoms, outcome after discontinuation, relapses and disease states, etc....) was collected from the prescription data. The association between the specific symptoms and the suspected drug was evaluated using the algorithm of Kitaguchi et al. (IYAKUHIN KENKYU 1983; 14 : 980-992).3) Also, the 98 patients were screened for subjective symptoms by interview using an ADR check list, and the cases that complained of symptoms of suspected ADRS were selected.4) In the selected cases, risk information was collected by talking with the patients, and the association between symptoms and the suspected drug was evaluated by this algorithm.
Results : 1) 16 cases with 26 symptoms had discontinued drug treatment. In these cases, the information related to the outcome after the drug discontinuation and disease states were obtained;not much information was available from the medication records. By using the algorithm, in 46% of the symptoms of these cases, the association between the symptoms and the drug was assessed as “possible”. Percentages of “definite”, “probable” and “remote” were 4%, 27% and 23%, respectively. 2) As a consequence of screening, 27 patients with 82 symptoms were suspected of ADRS. In these cases, there was little information related to timing, outcome and disease state. In fact, in half of the symptoms of these cases, the association between symptoms and the suspected drug could not be precisely determined.
Conclusion : For the purpose of improvement in quality of ADR reports, community pharmacies need to develop a good relationship with health care agencies or providers to share clinical information and risk informations, as well as, to collect the time course information related to ADRS from the appearance of the symptoms to disappearance after drug discontinuation. The event monitoring system in Japan does not require causality evaluations for suspected ADRS now, however, the intention to effectively evaluate causality will improve the usefulness of ADR reports.
