Characteristics of Post-Marketing Studies and their Contribution to Post-Marketing Safety Measures in Japan
- PDF / 244,475 Bytes
- 7 Pages / 595.276 x 790.866 pts Page_size
- 90 Downloads / 160 Views
ORIGINAL RESEARCH ARTICLE
Characteristics of Post-Marketing Studies and their Contribution to Post-Marketing Safety Measures in Japan Kazuhiro Kanmuri • Mamoru Narukawa
Springer International Publishing Switzerland 2014
Abstracts Introduction Post-marketing activities to continuously assess new drugs have been actively driven around the world. In Japan, post-marketing surveillance (PMS) studies have commonly been performed to assess the safety and efficacy of new drugs in the clinical setting, in tandem with the safety reporting system. However, to date, little has been reported on the usefulness and role of the PMS study. Objective We conducted research to investigate the implications and utility of the safety information obtained from PMS studies, characteristics of the PMS studies, and how the safety and efficacy information obtained by a new drug’s PMS program contributes to timely label changes. Methods Re-examination reports for 150 products were reviewed, along with their PMS study data and information obtained from the safety reporting system (e.g., spontaneous reports by healthcare professionals, adverse drug reaction reports, and foreign reports from the marketing authorization holders). The evidence source for each safety-/efficacy-related label change was reviewed. Results For all 150 products, it was confirmed that at least one PMS study had been conducted during the product’s re-examination period. In total, 302 PMS studies were performed, which included approximately 490,000 patients for safety analyses in the PMS studies. All 302 PMS studies were conducted as observational studies without a comparator arm. Of the products, 8.7 % (13/150) had a safety-related label change as a result of a PMS study,
K. Kanmuri (&) M. Narukawa Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of Pharmaceutical Sciences, Kitasato University, Shirokane 5-9-1, Minato-ku, Tokyo 108-8641, Japan e-mail: [email protected]
whereas 68.0 % (102/150) had a label change as a result of the safety reporting system. Conclusion Commonly, one or two PMS studies are conducted, with an observational study design, during the re-examination period. There were few PMS studies targeting special populations, particularly geriatric, renal impairment and liver impairment patients. A major evidence source for safety-related label changes for new drugs in Japan is the safety reporting system, and safety-related label changes resulting from PMS studies are not frequent.
1 Introduction A common concern amongst healthcare professionals and health authorities is whether a new drug approved for marketing based on data collected from a limited population in the setting of clinical trials will show the expected balance of risk and benefit in the setting of real-world use [1–3]. Health authorities in the USA and European Union (EU) have been active in establishing schemes to strengthen postmarketing safety measures for the last decade. Japan’s health authority recently issued a Risk Management Plan Guidance to
Data Loading...
