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Evaluation of the Implementation of Additional Risk Minimization Activities in Europe, the USA, and Japan
Yuka Yasuoka1,2, Masayuki Kaneko3, Mamoru Narukawa3
1Department of Clinical Medicine (Pharmaceutical Medicine), Graduate School of Pharmaceutical Sciences, Kitasato University, Tokyo, Japan. yuka.yasuoka15@gmail.com.
Background:
Risk minimization activities are planned and conducted as part of a drug's risk management plan; additional risk minimization activities are implemented as needed in consideration of the regulations and medical environment in each country/region, as well as drug-specific factors.
Objective:
The present study was conducted with the aim of investigating the status of implementing additional risk minimization activities in Europe, the USA, and Japan and understanding the characteristics of such activities commonly conducted in these countries/regions.
Methods:
For new drugs approved between 2013 and 2017, the status of implementing the additional activities was investigated based on the information published on each of the regulatory agencies' websites. Next, we identified drugs approved in all three countries/regions and investigated drug-specific factors such as indications and safety concerns. Furthermore, the contents of the activities were analyzed from the viewpoint of whether they intended risk mitigation or risk prevention.
Results:
The status of implementing additional activities was 26.4% (42/159 drugs) in Europe, 7.6% (15/197 drugs) in the USA, and 64.8% (92/142 drugs) in Japan. Forty-five drugs that were approved in all three countries/regions were identified. Many drugs with additional activities displayed novel mechanisms of action in therapeutic areas such as oncology. Common additional activities were implemented for only three drugs and for two of these drugs, "teratogenicity" was identified as a safety concern subjected to additional activities.
Conclusions:
Risk minimization activities were considered to be largely influenced by differences in regulatory thinking, medical systems, such as the number of healthcare providers per patient and the insurance system, and cultural differences. For drugs with a risk for teratogenicity and those with side effects that differ from conventional therapies, there was a tendency to commonly implement additional activities.
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