Kenji Fukumuro

Study on literature monitoring of adverse drug reactions (ADR).

In order to grasp the current status of collecting the articles for literature monitoring of adverse drug reactions (ADR) in DI room and to utilize it as a guide for future activities, we investigated the contents and source of the articles which we ourselves selected, collected and reported in monthly drug information journal of our hospital during the period of 1980-1985. We also analysed the contents and source jounals of the articles describing on ADR which had been collected in our DI room during the past 6 years paying our attention to the drugs most frequently reported in the literatures in 1984, and compared with the results of on-line search using MEDLINE to examine the coverage.The selecting standard of the articles describing on ADR has been established in our DI room. The articles describing on the terms manifesting ADR symptoms as well as drug name or drug group name in the titles of the articles in particular case reports of ADR are indispensable.From the analysis of the articles collected according to this selecting standard, it was found that the drug groups most frequently reported in the literatures were 1) central nervous system agents, 2) cardiovascular agents, 3) hormone preparations, 4) antineoplastic agents and 5) antibiotic preparations, and this order showed an almost same tendency through the past 5 years. However, individual drug names most frequently reported in the literatures brought about considerable changes every year. According to the source journals reporting ADR, the four journals, “Lancet”, “Brit. Med. J.”, “J. Am. Med. Assoc.” and “N. Engl. J. Med.” were overwhelming, but Japanese journals reporting ADR were widely distributed without focusing on certain journal.From the study on the coverage, it was found that the number of articles we collected was apparently less than that of MEDLINE, but we had collected the articles describing on important ADR. This study suggests that the literature monitoring of ADR in DI room will play an important role in early collection and early communication of ADR.

Inquiries and survey procedures concerning adverse drug reactions.

In order to complete a collecting and investigating system for adverse drug reactions in our Drug Information (DI) room, we have analyzed 836 (13.4%) inquiries selected from a total of 6261 inquiries sent to the DI room from Sept. 1983 to Aug. 1984. The survey procedures were divided into 3 steps as indicators to clarify the depth of information and difficulty of answers:Step I: Adequate information can be presented by only package inserts-Solvers judgment is hardly necessary. Step II: Adequate information can be presented by drug handbooks (e. g. AMA-DE, PDR, AHFS, USP-DI, Extra Pharmacopoeia, etc.)-Solvers judgment is necessary. Step III: Adequate informtion can be presented only after original articles are referred to-Solvers judgment as well as the detail information is necessary.From the analysis of inquiries, the following results were obtained: the inquiries concerning. blood disorder and hepatic disorder were ranked first (more than 20%) according to symptomatic classification, and by pharmacotherapeutic category those concerning cardiovascular agents, antibiotic preparations, agents affecting central nervous system and antitumor agents were rated high. From the analysis of survey procedures, it was found that the inquiries classified as Step I was less than 30% and most inquiries were classified as Step II or Step III. Thus, an accumulation of detailed information and an adequate judgment are required for DI activity.We think that 3-step procedure for classification of inquiries used in the present analysis is a useful indicator to show depth of information and difficulty of answers.

Case Study on Drug Information Services of Hospital Pharmacy

This report presents the results of case study through questionnaires regarding drug information (DI) service of hospital pharmacy. Questionnaires were sent to 192, 90 and 61 doctors of different hospitals, A, B and C. The following is the study results:1. Doctors of hospital A who expected DI service to provide more detailed DI than package insert exceeded the number of doctors of hospital B. DI service of both hospitals could satisfy the needs of doctors in most cases, but one of the problems revealed was that doctors were sometimes not able to obtain information that satisfies them. Doctors pointed out that information supplied by hospital pharmacy was no better than information given in package insert. 2. The rate of doctors who had not inquired on the ground of the lack of DI in hospital pharmacy was higher in hospital B than in hospital A. 3. The reasons why the doctors take advantage of DI service of hospital pharmacy as pointed out by doctors of hospital A were varied, including “convenience, ” “readiness, ” “detailed information” and “objectiveness.” Reasons given by doctors of hospital B rather concentrated on certain points, eg, “readiness.” 4. Doctors of hospital C received information both on revision of inserted drug description and on “adverse reaction to drugs” more frequently than doctors of hospital A and B.