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

Abstract

Objectives To present a design for Prescription‐Event Monitoring in Japan (J‐PEM). Methods 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. Results and Conclusions 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. Copyright © 1999 John Wiley & Sons, Ltd.

Drug use investigation (DUI) and prescription‐event monitoring in Japan (J‐PEM)

“…Prescription-Event Monitoring in Japan (J-PEM) was launched by the Department of Pharmacoepidemiology, Faculty of Medicine, University of Tokyo, in 1997 as a cohort study to replace the DUI. 8 In the pilot study, which started in 1997, patients who were prescribed a new antidiabetic agent, troglitazone, were compared with those treated during the same period of time and prescribed another oral antidiabetic drug. 9 The study was sponsored by more than 20 drug companies and four contract research organizations; in addition, a dozen individuals provided ®nancial support.…”

“…J-PEM is a scheme for hypothesis generating, where the rates of adverse events are determined and the event rates are compared between the test and control drugs to detect unknown ADRs, as well as unknown problems associated with known ADRs. 8,9 When the ®rst and second pilot studies of J-PEM were started in 1997 and 1998, respectively, virtually no guidelines existed on ethical issues in epidemiological studies in Japan, except for those speci®cally drawn up for cancer registration, issued in 1996. 10 In J-PEM pilot studies, the researchers in the university and those representing JPA, JSHP, and JMARI decided that with regard to the ethical aspects, pilot studies would be conducted in a manner similar to that in the DUI, where approval by neither the institutional ethics board nor individual consent is required, though con®dentiality of personal data must be strictly maintained.…”

“…The method employed in J-PEM to maintain the con®dentiality is described elsewhere. 8,9 Brie¯y, in J-PEM, a pharmacist in the community or at hospital pharmacies registers the patient code created speci®cally for the J-PEM study but not the patient's name. Two questionnaires, one for the pharmacist who registered the patient and one for the prescribing doctor, are mailed to the pharmacist.…”

Event Monitoring and Evaluation by Community Pharmacists in Japan: A Pilot Study on Fenofibrate and Pemafibrate

“…Studies using similar methodologies have been conducted in New Zealand and Japan [ 2 , 4 ]. PEM in Japan (J-PEM) [ 5 , 6 ], which was launched in 1997, has been suspended in 2004. Instead, another investigation of drug-related events, called drug event monitoring (DEM), has been implemented in 2002 by community pharmacists under the purview of the Japan Pharmaceutical Association (JPA) [ 7 ] to monitor events occurring in prevalent users of some pre-selected study drugs [ 8 ].…”