1.1．Spontaneous Report Database and Case-control Studies
Japanese Journal of Pharmacoepidemiology 2020;25(2):56-63
In the current review, the relationship between the reporting odds ratio (ROR) and the case-control study is addressed.The proportional mortality ratio (PMR) obtained in the proportional mortality studies in the death registry cannot be regarded as the risk ratio (RR) in the cohort study, but, the mortality odds ratio (MOR) estimated by using deaths unrelated to the exposure as ‘controls’ can be regarded as the RR.In 2004, Rothman et al proposed to estimate the ROR which can be regarded as the RR by using proper ‘control events’ in the spontaneous reports database. However, in the study conducted in Japan where the RORs estimated from 20 ‘control events’ were compared with the RRs obtained from many ‘drug use investigations’, the ROR vs RR plots were so diverse.The author of the current review concludes that the study estimating the ROR in the spontaneous reports cannot be regarded as the case-control study as the case-control study should estimate the RR of the cohort study in the source population as the odds ratio (OR).The ‘disproportionality measures’ like the ROR in the spontaneous reports database should be used primarily to detect the signals of the association between a drug and an adverse outcome. However, spontaneous reports can contribute to the characterization of the adverse drug reactions and to determining the causal relationship as well. The methods of signal detection are evolving and it is hoped that Japanese researchers contribute to their further developments.
2.Appendix 1
Masao IWAGAMI ; Kotonari AOKI ; Manabu AKAZAWA ; Chieko ISHIGURO ; Shinobu IMAI ; Nobuhiro OOBA ; Makiko KUSAMA ; Daisuke KOIDE ; Atsushi GOTO ; Norihiro KOBAYASHI ; Izumi SATO ; Sayuri NAKANE ; Makoto MIYAZAKI ; Kiyoshi KUBOTA
Japanese Journal of Pharmacoepidemiology 2018;23(2):124-124
3.Appendix 2
Masao IWAGAMI ; Kotonari AOKI ; Manabu AKAZAWA ; Chieko ISHIGURO ; Shinobu IMAI ; Nobuhiro OOBA ; Makiko KUSAMA ; Daisuke KOIDE ; Atsushi GOTO ; Norihiro KOBAYASHI ; Izumi SATO ; Sayuri NAKANE ; Makoto MIYAZAKI ; Kiyoshi KUBOTA
Japanese Journal of Pharmacoepidemiology 2018;23(2):125-130
4.Appendix 3
Masao IWAGAMI ; Kotonari AOKI ; Manabu AKAZAWA ; Chieko ISHIGURO ; Shinobu IMAI ; Nobuhiro OOBA ; Makiko KUSAMA ; Daisuke KOIDE ; Atsushi GOTO ; Norihiro KOBAYASHI ; Izumi SATO ; Sayuri NAKANE ; Makoto MIYAZAKI ; Kiyoshi KUBOTA
Japanese Journal of Pharmacoepidemiology 2018;23(2):131-139
5.Appendix 4
Masao IWAGAMI ; Kotonari AOKI ; Manabu AKAZAWA ; Chieko ISHIGURO ; Shinobu IMAI ; Nobuhiro OOBA ; Makiko KUSAMA ; Daisuke KOIDE ; Atsushi GOTO ; Norihiro KOBAYASHI ; Izumi SATO ; Sayuri NAKANE ; Makoto MIYAZAKI ; Kiyoshi KUBOTA
Japanese Journal of Pharmacoepidemiology 2018;23(2):140-143
6.Appendix 5
Masao IWAGAMI ; Kotonari AOKI ; Manabu AKAZAWA ; Chieko ISHIGURO ; Shinobu IMAI ; Nobuhiro OOBA ; Makiko KUSAMA ; Daisuke KOIDE ; Atsushi GOTO ; Norihiro KOBAYASHI ; Izumi SATO ; Sayuri NAKANE ; Makoto MIYAZAKI ; Kiyoshi KUBOTA
Japanese Journal of Pharmacoepidemiology 2018;23(2):144-146
7.Task Force Report on the Validation of Diagnosis Codes and Other Outcome Definitions in the Japanese Receipt Data
Masao IWAGAMI ; Kotonari AOKI ; Manabu AKAZAWA ; Chieko ISHIGURO ; Shinobu IMAI ; Nobuhiro OOBA ; Makiko KUSAMA ; Daisuke KOIDE ; Atsushi GOTO ; Norihiro KOBAYASHI ; Izumi SATO ; Sayuri NAKANE ; Makoto MIYAZAKI ; Kiyoshi KUBOTA
Japanese Journal of Pharmacoepidemiology 2018;23(2):95-123
Although the recent revision of the ministerial ordinance on Good Post-marketing Study Practice (GPSP) included the utilization of medical information databases for post-marketing surveillance, there has been limited research on the validity of diagnosis codes and other outcome definitions in Japanese databases such as administrative claims (“receipt”) database. This task force proposed how to conduct good validations studies, based on the narrative review on around 100 published papers around the world. The established check list consists of ： (ⅰ) understanding the type of the database (e.g. administrative claims data, electronic health records, disease registry) ； (ii) understanding the setting of the validation study (e.g. “population-based” or not) ； (iii) defining the study outcome ； (iv) determining the way of linkage between databases ； (v) defining the gold standard ； (vi) selecting the sampling method (e.g. using the information of all patients in the database or a hospital, random sampling from all patients, random sampling from patients satisfying the outcome definition, random sampling from patients satisfying and not satisfying the outcome definition, “all possible cases” method) and sample size ； (vii) calculating the measures of validity (e.g. sensitivity, specificity, positive predictive value, negative predictive value) ； and (viii) discussing how to use the result for future studies. In current Japan, where the linkage between databases is logistically and legally difficult, most validation studies would to be conducted on a hospital basis. In such a situation, detailed description of hospital and patient characteristics is important to discuss the generalizability of the validation study result to the entire database. This report is expected to encourage and help to conduct appropriate validation studies.
8.3. A Review of Completed Activities of “The Task Force to Make an Ideal Pharmacovigilance Plan (PVP) in Japan” : Evaluation of the Published Pharmacovigilance Plan (PVP) by JSPE's Check List and the Future Challenges&l
Japanese Journal of Pharmacoepidemiology 2015;19(2):115-122
Following the notice of “Guidance of Drug Risk Management Plan (RMP)” by MHLW in 2012, Japanese Society for Pharmacoepidemiology (JSPE) started. “A Task Force to make an acceptable Pharmacovigilance Plan (PVP) in Japan” from May 2013. As an outcome, the force published a check list used to evaluate individual PVP for a specific medicinal product together with the guidance for the use of the check list in “Yakuzai-ekigaku”, Journal of JSPE. During over one year since RMP was implemented, RMPs with PVP (included as a component of RMP) were published for 40 compounds and we tried to evaluate those PVPs using the check list we developed. It turns out that an answer to the first question in the check list “Is the necessity of additional PVP described?” was “No” for all 40 PVPs. More serious problem was that one of a few stereotyped study designs was selected in all of the 40 PVPs. No rationale was given to explain why the selected study design could achieve the study aim associated with the important problems specified in the section of safety specification. We conclude that although RMP has been implemented over one year ago, the conventional study design remains to be used in the actual PVP and the main messages of ICH E2E guideline have not been fully realized.
9.Good Pharmacovigilance Planning in Japan: Proposals from the “Task Force for Good Pharmacovigilance Planning in Japan” of Japanese Society for Pharmacoepidemiology (JSPE)
Osamu KOMIYAMA ; Kotonari AOKI ; Akira KOKAN ; Kiyoshi KUBOTA
Japanese Journal of Pharmacoepidemiology 2015;20(2):73-83
The reform of regulation is proposed to implement the Pharmacovigilance Planning (PVP) based on the ICH E2E guidelines as indicated in the notification of Risk Management Plan (J-RMP). Even after the J-RMP is enforced, the pharmacovigilance method still heavily depends on the traditional methods like “drug use results surveys”. The “Good Post-marketing Study Practice (GPSP)” ordinance and related notifications are the root causes of the malfunctioned operation of the system. Specifically, 1) the GPSP ordinance does not encourage the investigations according to the ICH E2E notification and 2) it is believed that the pharmacovigilance method should be limited to one of the three options only, namely, “drug use results surveys”, “specific use surveys” and “post-marketing clinical studies”. The followings are proposed:
• The GPSP ordinance should be revised to encourage referring the annex “pharmacovigilance methods” in “Pharmacovigilance planning”.
• The use of the early post-marketing phase vigilance (EPPV) should be restricted to the drugs marketed at the same time in the world or marketed for the first time in Japan.
• The notification connecting the “Good Vigilance Practice (GVP)” and GPSP ordinances (March 11, 2013, No 0311-7) should be revised to include a prescription that the “Safety Control Manager encourage the Post-marketing Surveillance Control Manager to develop a pharmacovigilance plan according to the ICH-E2E guidelines”.
• Forms attached to the individual RMP submissions should be revised according to the J-RMP notification.
• The notification on the RMP development (No.0426-1 and No.0426-2, on April 26, 2012) should be revised to indicate that the study design is acceptable to the health professionals.
• It should be clarified that the additional pharmacovigilance activities may be conducted by the divisional cooperation in the world or may be conducted as a non-clinical study, if appropriate.
10.Checklist and Guidance of Scientific Approach to Developing Pharmacovigilance Plan (PVP) in Japan: A Report from a Task Force of JSPE
Kiyoshi KUBOTA ; Kotonari AOKI ; Hisashi URUSHIHARA ; Tatsuo KAGIMURA ; Shigeru KAGEYAMA ; Daisuke KOIDE ; Akira KOKAN ; Tsugumichi SATO ; Toshiaki NAKAMURA ; Ken NAKAJIMA ; Naoya HATANAKA ; Takeshi HIRAKAWA ; Kou MIYAKAWA ; Mayumi MOCHIZUKI
Japanese Journal of Pharmacoepidemiology 2014;19(1):57-74
A Task Force team consisting of members from pharmaceutical companies --a central player to develop and implement RMP (Risk Management Plan)-- as well as health care professionals and members from academia was established in JSPE. The Task Force developed guidance for scientific approach to practical and ICH-E2E-compliant Pharmacovigilance Plan (PVP) stated in Japanese Risk Management Plan issued in April 2012 by the Ministry of Health, Labour and Welfare. The guidance contains the following topics.
1．Introduction: JSPE's activities and this task force's objectives for pharmacovigilance activities
2．How to select Safety Specification (SS) and describe its characteristics
・Selection of SS
・Characterization of SS
・Association with Research Questions (RQ)
3．How to define and describe RQ
・What is RQ ?
・RQ interpretation in other relevant guidelines
・Methodology to develop RQ for PVP with examples
・Best approach to integrating PVP for whole aspects of safety concern
4．How to optimize PVP for specific RQ
・Routine PVP or additional PVP ?
・Additional PVP design (RQ and study design, RQ structured with PICO or GPP's research objectives, specific aims, and rationale)
・Checklist to help develop PVP
5．Epilogue:
・What can/should be “Drug use investigation” in the context of ICH-E2E-compliant PVP.
・Significance of background incidence rate and needs for comparator group
・Infrastructure for the future PVP activities
6．Appendix: Checklist to help develop PVP activities in RMP
The task force team is hoping that this guidance help develop and conduct SS and PVP in accordance with ICH E2E, as stated in Japanese Risk Management Plan Guideline.
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