Pharmaceutical company perspectives on current safety risk communications in Japan

Abstract

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. The final report was issued in 2010. One agenda item of this restructuring was the improvement of drug-related safety risk communications. Our research group on drug safety risk communications, which is funded by the Government of Japan, surveyed pharmaceutical companies regarding their perspective on current risk communications. The survey was conducted using an anonymous questionnaire developed for this study which included the three operational domains of targets, contents, and measures of drug risk communication. Fifty-two of the 74 member companies of the Post-marketing Surveillance Subcommittee of the Japan Pharmaceutical Manufacturer’s Association participated, and this response rate of more than 70% was considered sufficient to ensure the external validity of the survey results. Results showed that the most highly prioritized aspect of risk messaging was the strength of evidence, and that outcome evaluation of risk communication gained recognition. Further, while physicians and pharmacists were the most prioritized communication targets, pharmacovigilance departments devoted the most resources to regulators, at more than 30%. The Internet was recognized as a useful public source of risk information, whereas Drug Guides for Patients delivered on the web were considered under-recognized. Further discussion of these results with the aim of enhancing the restructuring of the Japanese drug regulatory administration system are warranted.Electronic supplementary materialThe online version of this article (doi:10.1186/2193-1801-3-51) contains supplementary material, which is available to authorized users.

The effectiveness of direct to healthcare professional communication – A systematic review of communication factor studies

“…While the other three factors (i.e. "content," "media" and "recipient", as "effect" is beyond the scope of this review) were covered by multiple studies, only one study reports on the perspective of the communicative role of industry and regulators, namely Urushihara et al 38 Even though this factor may seem less important, the absence of studies does call for more research because efforts to evaluate the effectiveness of risk minimization measures should encompass the entire communication process. While not directly relevant to other geographical areas nor representative of industry perspectives, Urushihara et al's study invites questions about the compatibility of industry risk minimization practices and the objectives of communicative risk minimization measures targeting HCPs.…”

Analyzing occupational risks of pharmaceutical industry under uncertainty using a Bow-Tie analysis

“…This study also was incapable to capture model uncertainty owing to the individual difference among the input events in FTA or ETA. There is limited research in the literature related to workers health and safety assessment in pharmaceutical industry [1,5,[45][46][47][48][49]] since the quality risk management is commonly studied in this industry. As it is evident in the previous studies in the literature, this paper is the first QRA study performing Fuzzy Bow-Tie for pharmaceutical industry to analyze and visualize risks, causes and consequences of potential risk events and their impacts with possible preventive and protective control measures or barriers in prospective manner.…”

Community pharmacists’ knowledge and perceptions on risk management plans in the Southern Region of Portugal

“…Information communications, particularly safety risk information, are supervised by the regulatory authority in the country and streamed down to concerned regulators, healthcare professionals, patients, and other parties of interest (15). Regardless of strong recommendations for adapting communication to specific recipients, the opportunity for the general public, patients, and practitioners to be involved in this discussion is still limited (16,17).…”

“…According to The Erice Declaration on Communicating Drug Safety Information, risk communication is a public health activity which depends on the mutual responsibility of all players-patients, healthcare professionals, pharmaceutical industry, drug regulators, academia, and the media (15). Information communications, particularly safety risk information, are supervised by the regulatory authority in the country and streamed down to concerned regulators, healthcare professionals, patients, and other parties of interest (15).…”