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Pharmaceutical company perspectives on current safety risk communications in Japan.

Urushihara H, Kobashi G, Masuda H, Taneichi S, Yamamoto M, Nakayama T, Kawakami K, Matsuda T, Ohta K, Sugimori H - Springerplus (2014)

Bottom Line: 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.Further discussion of these results with the aim of enhancing the restructuring of the Japanese drug regulatory administration system are warranted.

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Yoshidakonoe-cho, Sakyo-ku, Kyoto, 606-8501 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.

No MeSH data available.


Related in: MedlinePlus

Prioritization of target audiences by pharmacovigilance staff at pharmaceutical companies in safety risk communication for pharmaceutical products. Respondents rated these criteria from first to eighth according to their importance as a target for risk communications.
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Fig2: Prioritization of target audiences by pharmacovigilance staff at pharmaceutical companies in safety risk communication for pharmaceutical products. Respondents rated these criteria from first to eighth according to their importance as a target for risk communications.

Mentions: Relative importance of the eight communication targets was rated (Figure 2). Physicians were ranked first by 31 respondents. Pharmacists were not ranked first by any respondent but were ranked second by 27 respondents; patients were ranked first by 8 respondents, second by 4, and third by 10; paramedics were ranked third by 14 respondents; and the regulatory authority was ranked fourth by 14. The public and media ranked lower than in-company divisions. The degree of subjective success in risk communication was assessed for each of the above communication parties (Figure 3). Risk communication with the regulatory agency was rated as most successful among the parties (‘fairly successful’ or above: 100%), followed by pharmacists and physicians (both 98.0%); whereas paramedics (76.0%), patients (61.7%), the media (53.1%) and the public (31.1%) were rated lower than in-company divisions (87.8%). Pharmacovigilance departments allocated the greatest time resources to the regulatory agency (mean 31.4%), followed by physicians (24.9%) and pharmacists (14.7%, Figure 4). The rough estimation of work-time allocation to paramedics (5.0%), patients (4.8%), the public (1.9%), and the media (1.6%) were smaller than that for in-company divisions (13.0%).Figure 2


Pharmaceutical company perspectives on current safety risk communications in Japan.

Urushihara H, Kobashi G, Masuda H, Taneichi S, Yamamoto M, Nakayama T, Kawakami K, Matsuda T, Ohta K, Sugimori H - Springerplus (2014)

Prioritization of target audiences by pharmacovigilance staff at pharmaceutical companies in safety risk communication for pharmaceutical products. Respondents rated these criteria from first to eighth according to their importance as a target for risk communications.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3921345&req=5

Fig2: Prioritization of target audiences by pharmacovigilance staff at pharmaceutical companies in safety risk communication for pharmaceutical products. Respondents rated these criteria from first to eighth according to their importance as a target for risk communications.
Mentions: Relative importance of the eight communication targets was rated (Figure 2). Physicians were ranked first by 31 respondents. Pharmacists were not ranked first by any respondent but were ranked second by 27 respondents; patients were ranked first by 8 respondents, second by 4, and third by 10; paramedics were ranked third by 14 respondents; and the regulatory authority was ranked fourth by 14. The public and media ranked lower than in-company divisions. The degree of subjective success in risk communication was assessed for each of the above communication parties (Figure 3). Risk communication with the regulatory agency was rated as most successful among the parties (‘fairly successful’ or above: 100%), followed by pharmacists and physicians (both 98.0%); whereas paramedics (76.0%), patients (61.7%), the media (53.1%) and the public (31.1%) were rated lower than in-company divisions (87.8%). Pharmacovigilance departments allocated the greatest time resources to the regulatory agency (mean 31.4%), followed by physicians (24.9%) and pharmacists (14.7%, Figure 4). The rough estimation of work-time allocation to paramedics (5.0%), patients (4.8%), the public (1.9%), and the media (1.6%) were smaller than that for in-company divisions (13.0%).Figure 2

Bottom Line: 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.Further discussion of these results with the aim of enhancing the restructuring of the Japanese drug regulatory administration system are warranted.

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Yoshidakonoe-cho, Sakyo-ku, Kyoto, 606-8501 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.

No MeSH data available.


Related in: MedlinePlus