Adverse drug reaction monitoring: comparing doctor and patient reporting for new drugs.

摘要

PURPOSE: To compare the frequency of adverse drug reactions (ADRs) recorded by doctors with perceived ADRs reported by patients during hospitalization and post-discharge and to compare both to formal reporting in Thailand. SETTING: Tertiary teaching hospital, North-East Thailand. METHODS: Over a 6-month period doctors were requested to record ADRs to 13 recently marketed index drugs, occurring during hospitalization and after discharge, using specific forms. Patient perceived ADRs were detected by daily pharmacist interviews during hospitalization and a symptom checklist questionnaire after discharge. RESULTS: In total, 203 in-patients were prescribed an index drug and interviewed. Doctors recorded 13 ADRs in these patients, resulting in seven drugs being stopped. In-patients reported 15 further symptoms, but 12 were assessed as unlikely to be an ADR. Of 160 patients who continued the index drug after discharge, 152 accepted questionnaires and 88 (58%) were returned. Patients identified 249 symptoms, of which the pharmacist assessed 190 (76%) as probably or possibly ADRs, using a previously developed method. Only 26 symptoms were noted in out-patient department (OPD) records, although most patients claimed to have informed doctors about them. Doctors recorded only five symptoms on ADR forms, all associated with drug discontinuation. During the study period, four reports were received by the Thai FDA on these 13 drugs, none from this hospital. CONCLUSIONS: Forms encouraging doctors to identify ADRs may be an effective method of increasing recording, particularly in the in-patient setting. A combination of methods including patient reporting may enable pharmacists to increase formal ADR reporting.