Evaluation of rapid drug safety communication materials for patients in Japan.

Since 2011, pharmaceutical companies in Japan have been required to issue two types of documents regarding severe adverse drug reactions reported post-marketing, namely the Rapid Safety Communication Materials for Patients and the Related Materials. However, the adequacy of these documents has not yet been systematically assessed. The aim of this study was to evaluate the adequacy of these two types of materials.

[Current Status and Development of Drug Information Infrastructure System for the Public in Japan and Overseas].

With the progress of medical treatment, information on drugs, etc. is overflowing on the media and the Internet, and some of them are leading to uncertain information for the purpose of profit, and some of them are wrong information or inaccurate information, and the effect on the patient is regarded as a problem. In Japan, information on public pharmaceuticals for patients and consumers is provided on the Internet, but its utilization is not sufficient.

A Prospective, Randomized, Open-Label Trial of Early versus Late Favipiravir Therapy in Hospitalized Patients with COVID-19.

Favipiravir is an oral broad-spectrum inhibitor of viral RNA-dependent RNA polymerase that is approved for treatment of influenza in Japan. We conducted a prospective, randomized, open-label, multicenter trial of favipiravir for the treatment of COVID-19 at 25 hospitals across Japan. Eligible patients were adolescents and adults admitted with COVID-19 who were asymptomatic or mildly ill and had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

[Significance and Role of Academic Detailing for Optimal Medication].

"Academic detailing" is used to clearly explain scientific issues. In the field of clinical practice, "academic detailing" is a form of interactive educational outreach to physicians in order to provide unbiased, non-commercial, evidence-based information about medications and other therapeutic modalities, with the goal of improving patient care. It is necessary to provide proper information about prescription drugs for their appropriate use in clinical practice.

[Activities of Choosing Wisely and Role of Pharmacists].

Choosing Wisely (CW) is a pharmaceutical campaign activity that is spreading rapidly internationally. Briefly, it is an activity "aiming for appropriate medical care by reviewing the medical practice that is practiced despite lack of evidence from the viewpoint of evidence based medicine (EBM)". Here, healthcare workers and patients, through dialogue, are aiming to be able to carry out medical practices (examinations, treatment) that are scientifically validated, truly necessary, and have few side effects.

Adaptation of the European Commission-recommended user testing method to patient medication information leaflets in Japan.

Background: The safe use of drugs relies on providing accurate drug information to patients. In Japan, patient leaflets called Drug Guide for Patients are officially available; however, their utility has never been verified. This is the first attempt to improve Drug Guide for Patients via user testing in Japan.

Multicenter Phase II Study of Nedaplatin and Irinotecan for Patients with Squamous Cell Carcinoma of the Lung: Thoracic Oncology Research Group 0910.

Squamous cell carcinoma (SCC) of the lung is moderately responsive to anticancer drugs, but no specific chemotherapy regimens have yet been established. We conducted a multicenter phase II study of nedaplatin (NP) and irinotecan (CPT) for SCC of the lung. Fifty patients underwent 4 to 6 cycles of chemotherapy comprising of NP at 100 mg/m(2) on day 1 and CPT at 60 mg/m(2) on days 1 and 8 every 4 weeks.

Phase I and pharmacokinetic study of erlotinib administered in combination with amrubicin in patients with previously treated, advanced non-small cell lung cancer.

Objectives: We conducted a phase I trial of erlotinib, an epidermal growth factor receptor tyrosine kinase inhibitor, combined with amrubicin, a topoisomerase II inhibitor. The aim was to determine the maximum tolerated dose, the dose-limiting toxicities (DLTs), and the pharmacokinetics of this combination in patients with non-small cell lung cancer who had received previous chemotherapy.

Methods: A total of 9 patients with stage IV disease were treated at 3-week intervals with erlotinib once daily on days 1 through 21 plus a 5-minute intravenous injection of amrubicin on days 1 through 3.

[Drug information for patients (Package Leaflets), and user testing in EU].

Patients and consumers have desired high quality drug information in their pharmacotherapy, and are entitled to receive it. It is desirable that the information should be aimed at shared decision-making between patients and healthcare professionals about medications. The quality of drug information available to patients should also be assured.

Relationship between health literacy, health information access, health behavior, and health status in Japanese people.

Objective: To examine the relationship between health literacy (HL), health information access, health behavior, and health status in Japanese people.

Methods: A questionnaire survey was conducted at six healthcare facilities in Japan. Eligible respondents aged 20-64 years (n=1218) were included.

Patients views and experiences in online reporting adverse drug reactions: findings of a national pilot study in Japan.

Background: Patients have been allowed to report adverse drug reactions (ADRs) directly to the government in some countries, which would contribute to pharmacovigilance.

Objective: We started a pilot study to determine whether web-based patient ADR reporting would work in Japan. This article aims to describe the characteristics of the patient reporters, and to clarify patient views and experiences of reporting.

[Academic detailing for best practice and pharmacists' role].

It is necessary to offer the proper information about prescription drugs for appropriate use of them in clinical practice. However, a lot of time and labor is required to comprehensively collect the information necessary for clinical application and it could be extremely difficult. If the clinical experience and other information is derived solely on a commercial basis, then it may lead to improper prescription practices.

Pharmaceutical company perspectives on current safety risk communications in Japan.

In 1987, a group infection of hepatitis in patients receiving a contaminated fibrinogen product was first reported to the Japanese regulatory agency. Eventually, this serious drug incident involved more than 10,000 cases of infection. In response, the Government of Japan established a responding inspection committee in 2008 to make recommendations for the restructuring of drug regulatory administration.