A design for prescription-event monitoring in Japan (J-PEM)

To present a design for Prescription-Event Monitoring in Japan (J-PEM).

In J-PEM, pharmacists are asked to register patients who are prescribed the 'test drug' or a 'control drug' for the first time ever, the drug, and prescribing physician. Although J-PEM does not identify all users of a drug, this method provides concurrent controls. In J-PEM, a questionnaire for the pharmacist and one for the prescribing physician are mailed 6 months after the drug to be monitored is first prescribed to a patient. Doctors and pharmacists are asked to report events that occurred in the patient after the drug was prescribed. The questionnaire for the physician includes questions that are specific to the class of drug that was prescribed, to obtain information on possible confounding variables. Pharmacists are requested to give information on all concomitant drugs used by the patient during or for a part of the period that the patient was taking the drug to be monitored.

Compared with the UK PEM, the weakness of J-PEM is its inability to identify all users of a drug, and its strengths are the availability of concurrent controls and a relatively large amount of information per patient.