Possibility of Database Research as a Means of Pharmacovigilance in Japan Based on a Comparison with Sertraline Postmarketing Surveillance

Hirano, Yoko; Asami, Yuko; Kuribayashi, Kazuhiko; Kitazaki, S; Yamamoto, Yuji; Fujimoto, Yoko

doi:10.1016/j.vhri.2017.05.002

Cited by 5 publications

(9 citation statements)

References 6 publications

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“…External validity is important in database research. A previous study showed that the characteristics of patients with antidepressant prescriptions extracted from the MinaCare database were similar to those of patients in a postmarketing surveillance study for antidepressants, which reflects actual clinical practice 26 . The demographic characteristics of the population in the present study, such as mean age and sex distribution, are also similar to those of a prospective, multicenter, epidemiological study of Japanese outpatients with MDD aged 18 to 65 years 47 .…”

Section: Discussionsupporting

confidence: 76%

“…A cross-sectional study found that age trends by sex for various parameters, including blood pressure, lipid parameters, and blood glucose levels, were generally consistent across the MinaCare database and Japanese national survey data sources 25 . Another study reported that the characteristics of sertraline-prescribed patients in the MinaCare database were similar to those of a postmarketing surveillance study conducted to collect the safety and effectiveness information of sertraline in routine clinical practice, as mandated by the Japanese regulatory agency 26 …”

Section: Methodsmentioning

confidence: 89%

“…25 Another study reported that the characteristics of sertralineprescribed patients in the MinaCare database were similar to those of a postmarketing surveillance study conducted to collect the safety and effectiveness information of sertraline in routine clinical practice, as mandated by the Japanese regulatory agency. 26 Medical and pharmaceutical claims data recorded between April 1, 2014, and March 31, 2020, were extracted and used for the present study. The database contained data for approximately 3.4 million individuals with medical/pharmaceutical claims during the period between April 1, 2014, and March 31, 2020.…”

Section: Data Sourcementioning

confidence: 99%

See 2 more Smart Citations

Inverse Association Between Persistence With Antidepressant Medication and Onset of Chronic Pain in Patients With Depression

Higa

Nakamura²,

Ohwaki

2022

J Clin Psychopharmacol

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Purpose/BackgroundDespite the known involvement of depression in chronic pain, the association between persistence with and adherence to antidepressant medication and onset of chronic pain in patients with depression remains unclear.Methods/ProceduresThis retrospective cohort study used a Japanese claims database to extract data for adult patients with depression who were prescribed antidepressants between April 2014 and March 2020. Patients were divided into groups according to duration of continuous prescription of antidepressants (≥6 months [persistent group] and <6 months [nonpersistent group]) and medication possession ratio (≥80% [good adherence group] and <80% [poor adherence group]). The outcome was onset of chronic pain, which was defined as continuous prescription >3 months of analgesics and diagnosis of pain-related condition after discontinuation of the first continuous antidepressant prescription. The risk of onset of chronic pain was compared between the paired groups.Findings/ResultsA total of 1859 patients were selected as the study population and categorized as the persistent (n = 406) and nonpersistent (n = 1453) groups, and good adherence (n = 1551) and poor adherence (n = 308) groups. Risk of onset of chronic pain was significantly lower in the persistent group than in the nonpersistent group after controlling for confounding via standardized mortality ratio weighting (hazard ratio, 0.38; 95% confidence interval, 0.18–0.80; P = 0.011). There was no significant difference between the good and poor adherence groups.Implications/ConclusionsAntidepressant persistence for ≥6 months is recommended and may reduce the onset of chronic pain in patients with depression.

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Section: Discussionsupporting

confidence: 76%

Section: Methodsmentioning

confidence: 89%

Section: Data Sourcementioning

confidence: 99%

See 1 more Smart Citation

Inverse Association Between Persistence With Antidepressant Medication and Onset of Chronic Pain in Patients With Depression

Higa

Nakamura²,

Ohwaki

2022

J Clin Psychopharmacol

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“…Pv these days also covers drug therapy-related problems (DTRPs) shown by herbals, traditional, complementary, and alternative medicines (TCAMs), biologicals and blood products, medical devices, and vaccines [6,11,12]. Pharmacoepidemiologic studies are popular these days to evaluate the safety and effectiveness of medicines in clinical practice [13]. Materiovigilance (Mv) has similar reporting purposes and approaches as that of Pv but deals with adverse reactions caused by medical devices and their prevention strategies [2-4, 8, 14, 15].…”

Section: Pharmacovigilance and Emergence Of Materiovigilancementioning

confidence: 99%

Materiovigilance in Perspective: Understanding Its Concept and Practice in the Global Healthcare System

Sapkota

Palaian

Shrestha

et al. 2023

Ther Innov Regul Sci

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Materiovigilance (Mv) has the same purpose and approach in ensuring patient safety as pharmacovigilance but deals with medical devices associated with adverse events (MDAEs) and their monitoring. Mv has been instrumental in recalling many defective or malfunctioning devices based on their safety data. All MDAEs, such as critical or non-critical, known, or unknown, those with inadequate or incomplete specifications, and frequent or rare events should be reported and evaluated. Mv helps to improve medical devices’ design and efficiency profile and avoid device-related complications and associated failures. It alerts consumers and health professionals regarding counterfeit or substandard devices. Common events reported through Mv are device breakage and malfunction, entry- and exit-site infections, organ perforations or injuries, need for surgery and even death, and life cycle assessment of devices. Health authorities globally have developed reporting frameworks with timeframes for MDAEs, such as MedWatch in the USA, MedSafe in New Zealand, and others. Health professionals and consumers need to be made aware of the significance of Mv in ensuring the safe use of medical devices and getting familiar with the reporting procedures and action plans in case of a device-induced adverse event.

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“…Very few studies [8, 9] have been reported that examined the possibility of using a DB as an alternative to the conventional PMS studies in Japan. Hence, the objective of this study was to understand the extent to which the healthcare claims DB captures the safety profile of patients prescribed eribulin mesylate (Halaven ® , Eisai Co., Ltd., Japan) through the comparison of patient characteristics, drug use, and adverse event (AE) incidence between the data extracted from a large-scale DB and data extracted from a conventional prospective PMS of metastatic breast cancer patients treated with eribulin.…”

Section: Introductionmentioning

confidence: 99%

Use of a Healthcare Claims Database for Post-Marketing Safety Assessments of Eribulin in Japan: A Comparative Assessment with a Prospective Post-Marketing Surveillance Study

Sakata

Matsuoka

Ohashi

et al. 2019

Drugs - Real World Outcomes

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BackgroundTo understand the extent to which a large-scale healthcare claims database (DB) captures the safety profile of eribulin mesylate (Halaven®, Eisai Co., Ltd., Japan), we compared patient characteristics, drug use, and adverse events (AEs) between data for patients treated with eribulin retrieved from a DB and data for metastatic breast cancer patients from a conventional prospective post-marketing surveillance (PMS).MethodsWe descriptively summarized patient characteristics and AEs of 551 and 951 patients retrieved from DB and PMS, respectively, during 2011‒2013. Using 2814 patient data from the DB during 2011‒2016, the drug use and AE incidence over time were assessed.ResultsIn both datasets, 99.8% were females, and the mean age was 57.8 ± 10.7 years. The mean number of eribulin administration was 11.1 ± 10.9 and 10.1 ± 7.8 in DB and PMS, respectively. Although, overall, the difference in AE incidence between the two datasets was moderate, gaps were larger for nausea (DB: 73.32% vs. PMS: 15.77%), neutropenia (20.87% vs. 66.67%), stomatitis (37.39% vs. 10.94%), and alopecia (0.36% vs. 12.09%). During 2011‒2016, the observed incidence of anemia or pyrexia significantly decreased (trend test, p = 0.0009 for both).ConclusionGenerally, patient characteristics, drug use, and AE incidence between the DB and PMS were comparable; however, AEs such as neutropenia may require defining based on the laboratory data to achieve more comparable results in DBs. Besides the usefulness of healthcare claims DBs for long-term assessments, they may also serve as a good complementary to PMS in the pharmacovigilance of eribulin.

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Possibility of Database Research as a Means of Pharmacovigilance in Japan Based on a Comparison with Sertraline Postmarketing Surveillance

Abstract: Our results support the concept of using database research as a cost-effective pharmacovigilance tool that is free of selection bias . Further investigation using database research is required to confirm our preliminary observations.

Cited by 5 publications

References 6 publications

Inverse Association Between Persistence With Antidepressant Medication and Onset of Chronic Pain in Patients With Depression

Inverse Association Between Persistence With Antidepressant Medication and Onset of Chronic Pain in Patients With Depression

Materiovigilance in Perspective: Understanding Its Concept and Practice in the Global Healthcare System

Use of a Healthcare Claims Database for Post-Marketing Safety Assessments of Eribulin in Japan: A Comparative Assessment with a Prospective Post-Marketing Surveillance Study

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