Comparison of Adverse Event Reports by Physicians and Pharmacists in Japanese Adverse Drug Event Report Database (JADER) / 医薬品情報学

Objective: In Japan, healthcare professionals are required to report the adverse drug events that occur with the use of medicines to the Minister of Health, Labor, and Welfare. The reported information is collected in the Japanese Adverse Drug Event Report database (JADER) and is freely available. There are no reports that evaluated the adverse events (AEs) in JADER based on the need for a physician’s diagnosis. This study classified AEs by pharmacists or physicians in JADER based on the need for a physician’s diagnosis and evaluated the differences in their contents.Methods: AEs reported by pharmacists, physicians, pharmacists and physicians in the economic years 2004 to 2017 in JADER were collected annually, and the trends were compared. The AEs of methotrexate in 2017 were classified into two groups based on the need for a physician’s diagnosis. The necessity of a physician’s diagnosis was judged by two senior pharmacists and compared using the chi-squared test.Results: The number of AEs reported by pharmacists and physicians from 2004 to 2017 increased from 689 to 7,127 and from 20,933 to 39,382, respectively. Among the AEs of methotrexate in 2017, AEs requiring physician’s diagnosis reported by pharmacists were 337 events and physicians were 2,413 events. Whereas, AEs that did not require a physician’s diagnosis reported by pharmacists were 172 events and physicians were 321 events. Physicians had significantly more AEs requiring diagnosis than pharmacists did (p＜ 0.0001).Conclusion: The reports of pharmacists with JADER have fewer AEs with the diagnosis than those of physicians.

Association between Antipsychotic Use and Extrapyramidal Symptoms: / 医薬品情報学

<b>Objective: </b>To examine the association between atypical and typical antipsychotics and extrapyramidal symptoms (EPS), we analyzed the US Food and Drug Administration Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report database (JADER) from the Pharmaceuticals and Medical Devices Agency (PMDA).<br><b>Methods: </b>A reporting odds ratio was calculated and used to detect spontaneous report signals, with detection defined as a lower limit >1 in a 95% confidence interval.  In addition, time to onset and age at onset of EPS were investigated.<br><b>Results: </b>Drug-reaction pairs were identified in both FAERS (<i>n</i>=29,017,485) and JADER (<i>n</i>=2,079,653).  In analyses of both databases, significant associations were found between atypical and typical antipsychotics and EPS.  Atypical antipsychotics cause EPS with a longer duration of therapy compared to typical ones.  EPS in patients treated with atypical antipsychotics was observed at a broad range of ages compared to the patients treated with typical ones.<br><b>Conclusion: </b>Atypical antipsychotics, like typical ones, may increase the risk of EPS.  Because of the longer latency of onset, it may be difficult to find EPS associated with atypical antipsychotics.  Therefore, the severe symptom may be developed in patients treated with atypical antipsychotics.  The attention should be paid to the EPS in patients of all ages treated with atypical antipsychotics.