Research for Recognition of Pharmaceutical Companies toward the Effective Use of “Drug Guide for Patients” as Package Inserts for Patients

Hirohisa Doi; Rina Ito; Azusa Hara; Kazuhiro Asada; Michiko Yamamoto

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Research for Recognition of Pharmaceutical Companies toward the Effective Use of “Drug Guide for Patients” as Package Inserts for Patients

VernacularTitle:患者向け医薬品添付文書「患者向医薬品ガイド」の利活用に向けた製薬企業における認識調査
Author: Hirohisa DOI ¹ ; Rina ITO ¹ ; Azusa HARA ² ; Kazuhiro ASADA ³ ; Michiko YAMAMOTO ⁴
Author Information

1. Laboratory of Drug Informatics, Showa Pharmaceutical University
2. Laboratory of Social Pharmacy and Public Health, Showa Pharmaceutical University
3. Division of Drug Development and Regulatory Science, Faculty of Pharmacy, Keio University
4. Pharmacovigilance Department, Ohara Pharmaceutical Co., Ltd.
Keywords: drug guide for patients; routine risk minimization activity; risk management plan (RMP); user testing
From:Japanese Journal of Drug Informatics 2019;21(3):116-125
CountryJapan
Language:Japanese
Abstract: Objective: “Drug Guide for Patients” (DGP) is a drug information tool designated as one of the routine risk minimization activities in risk management plan (RMP) developed by the Ministry of Health, Labour and Welfare. However, patients and their families hardly recognize DGP. Therefore, we administered a questionnaire on drug consultation service of pharmaceutical companies that provide DGP with an aim to collect their views, elucidate problems when they prepare DGPs and examine effective utilization of DGP in the future.Methods: We sent a questionnaire by letter for 127 drug consultation service of pharmaceutical companies, and received questionnaire results using “Questant” that is web questionnaire making software. The results were examined using Fisher’s exact test or Pearson’s chi-squared test.Results: We obtained responses from 84 (66.1%) companies out of 127. As for the question of the published situation of DGP on their website, the most companies responded “Not published” with 47.6% and subsequently 41.7% for “Published for healthcare professionals”. The combined rate of “Published for Patients (3.6%)” and “Published for both healthcare professionals and patients (7.1%)” was only 10.7%. On the other hand, regarding the burden of companies making DGP, we found that more than 60% of pharmaceutical companies (63.5%) felt burdensome, whereas only 36.5% responded “Not burdensome.” Regarding the question on the role of DGP in RMP, pharmaceutical companies answered that the role is “sufficient” 3.6%, 29.8% “not sufficient”, and 66.6% “unknown”.Conclusion: Our results suggested that it is difficult for patients to get DGP from website of pharmaceutical companies and pharmaceutical companies felt burdensome in making DGP, and they recognized that DGP was not very much utilized by patients. Therefore, it would be necessary to improve the creation criteria of DGP. Furthermore, we felt it necessary to have the DGP known and utilized widely by (consumers and) patients.