Analysis of safety specifications in risk management plan at the time of drug approval and addition of clinically significant adverse reactions in the package insert post-approval in Japan.
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引用次数: 0
Abstract
Recently, post-marketing safety measures have been considered critical in Japan due to the globalization of drug development and the introduction of new drug approval systems. Pharmacists are expected to play an active role in ensuring the safety of drugs post-approval. Utilizing risk management plans (RMPs) to ensure safety throughout the development and post-marketing phases is becoming even more critical. In this study, we examine the relationship between the safety specifications (SSs) in RMPs at the time of drug approval and the adverse reactions (ARs) added to the clinically significant adverse reactions (CSARs) section of the package inserts (PIs) post-approval to determine whether SSs constitute useful drug information for pharmacists. The analysis included new active ingredient-containing drugs approved in Japan from FY2013 to 2019. A 2 × 2 contingency table was created and analyzed using odds ratios (ORs) and Fisher's exact test. The OR was 14.22 (95% CI: 7.85-24.77; p < .001), which indicates a strong relationship between the ARs being SSs at the time of approval and being added to the PIs as CSARs post-approval. The positive predictive value that SSs at the time of approval were added as CSARs to the PIs post-approval was 7.1%. In addition, a similar relationship was observed with the "approval in shorter-period drugs" reviewed for approval based on a limited number of clinical trials. Therefore, SSs in RMPs are important drug information for pharmacists in Japan.
期刊介绍:
PR&P is jointly published by the American Society for Pharmacology and Experimental Therapeutics (ASPET), the British Pharmacological Society (BPS), and Wiley. PR&P is a bi-monthly open access journal that publishes a range of article types, including: target validation (preclinical papers that show a hypothesis is incorrect or papers on drugs that have failed in early clinical development); drug discovery reviews (strategy, hypotheses, and data resulting in a successful therapeutic drug); frontiers in translational medicine (drug and target validation for an unmet therapeutic need); pharmacological hypotheses (reviews that are oriented to inform a novel hypothesis); and replication studies (work that refutes key findings [failed replication] and work that validates key findings). PR&P publishes papers submitted directly to the journal and those referred from the journals of ASPET and the BPS