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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 aspects according to the criteria of Media Doctor Australia in risk communication messages for pharmaceutical products by pharmacovigilance staff at drug companies. Evidence: Where relevant there is mention of the strength of evidence and correct interpretation. Stratification of patients with regard to harm: Mentions which groups of patients are most likely to be harmed. Number of people affected by harm: Some quantification of the number of people or percent of people affected by the harm. Novelty of harm: Mentions whether or not the harm was previously identified or mentions what is added to previous knowledge about it. Quantification of harms: Some quantification of harm in terms of severity. Benefit to harm ratio: Tries to balance reporting of both benefits and harms or gives some sense of the ratio between the two. Sources of information: Provides details on information sources and their potential COI, and reports independent source or mentions unsuccessful attempts to obtain corroboration. Treatment options: Mentions alternatives and discusses whether alternatives are more or less harmful. Each criterion was rated from first to eighth according to its importance in transmitting risk information.
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Fig1: Prioritization of aspects according to the criteria of Media Doctor Australia in risk communication messages for pharmaceutical products by pharmacovigilance staff at drug companies. Evidence: Where relevant there is mention of the strength of evidence and correct interpretation. Stratification of patients with regard to harm: Mentions which groups of patients are most likely to be harmed. Number of people affected by harm: Some quantification of the number of people or percent of people affected by the harm. Novelty of harm: Mentions whether or not the harm was previously identified or mentions what is added to previous knowledge about it. Quantification of harms: Some quantification of harm in terms of severity. Benefit to harm ratio: Tries to balance reporting of both benefits and harms or gives some sense of the ratio between the two. Sources of information: Provides details on information sources and their potential COI, and reports independent source or mentions unsuccessful attempts to obtain corroboration. Treatment options: Mentions alternatives and discusses whether alternatives are more or less harmful. Each criterion was rated from first to eighth according to its importance in transmitting risk information.

Mentions: The relative importance of eight aspects in the transmission of messages for risk information, which is known as the Media Doctor Australia rating criteria for adverse effects, was rated (Figure 1). Seventeen respondents ranked ‘evidence (mention of strength of evidence and correct interpretation)’ as the first-ranked aspect, followed by ‘stratification of patients with regard to harm (mentions which groups of patients are most likely to be harmed)’ and ‘number of people affected by harm (some quantification of the number of people or percent of people affected by the harm)’, with the total of the above three aspects accounting for approximately one-half of the first through fourth ranks. Less importance was given to the other aspects, with ‘treatment option’ assigned the lowest importance. When respondents were asked about what they paid attention to when creating messages for risk communication, 26 answered they would give consideration to the comprehensibility of contents, while 12 others focused on the prevention of health hazard as an outcome of risk communication. When asked what they would pay attention to in transmitting risk messages, 16 respondents answered the promptness of communication and 10 answered the medium used for communication. Four respondents emphasized the importance of behavioral changes as an outcome of message transmissions with the intention of risk minimization.Figure 1


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 aspects according to the criteria of Media Doctor Australia in risk communication messages for pharmaceutical products by pharmacovigilance staff at drug companies. Evidence: Where relevant there is mention of the strength of evidence and correct interpretation. Stratification of patients with regard to harm: Mentions which groups of patients are most likely to be harmed. Number of people affected by harm: Some quantification of the number of people or percent of people affected by the harm. Novelty of harm: Mentions whether or not the harm was previously identified or mentions what is added to previous knowledge about it. Quantification of harms: Some quantification of harm in terms of severity. Benefit to harm ratio: Tries to balance reporting of both benefits and harms or gives some sense of the ratio between the two. Sources of information: Provides details on information sources and their potential COI, and reports independent source or mentions unsuccessful attempts to obtain corroboration. Treatment options: Mentions alternatives and discusses whether alternatives are more or less harmful. Each criterion was rated from first to eighth according to its importance in transmitting risk information.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Fig1: Prioritization of aspects according to the criteria of Media Doctor Australia in risk communication messages for pharmaceutical products by pharmacovigilance staff at drug companies. Evidence: Where relevant there is mention of the strength of evidence and correct interpretation. Stratification of patients with regard to harm: Mentions which groups of patients are most likely to be harmed. Number of people affected by harm: Some quantification of the number of people or percent of people affected by the harm. Novelty of harm: Mentions whether or not the harm was previously identified or mentions what is added to previous knowledge about it. Quantification of harms: Some quantification of harm in terms of severity. Benefit to harm ratio: Tries to balance reporting of both benefits and harms or gives some sense of the ratio between the two. Sources of information: Provides details on information sources and their potential COI, and reports independent source or mentions unsuccessful attempts to obtain corroboration. Treatment options: Mentions alternatives and discusses whether alternatives are more or less harmful. Each criterion was rated from first to eighth according to its importance in transmitting risk information.
Mentions: The relative importance of eight aspects in the transmission of messages for risk information, which is known as the Media Doctor Australia rating criteria for adverse effects, was rated (Figure 1). Seventeen respondents ranked ‘evidence (mention of strength of evidence and correct interpretation)’ as the first-ranked aspect, followed by ‘stratification of patients with regard to harm (mentions which groups of patients are most likely to be harmed)’ and ‘number of people affected by harm (some quantification of the number of people or percent of people affected by the harm)’, with the total of the above three aspects accounting for approximately one-half of the first through fourth ranks. Less importance was given to the other aspects, with ‘treatment option’ assigned the lowest importance. When respondents were asked about what they paid attention to when creating messages for risk communication, 26 answered they would give consideration to the comprehensibility of contents, while 12 others focused on the prevention of health hazard as an outcome of risk communication. When asked what they would pay attention to in transmitting risk messages, 16 respondents answered the promptness of communication and 10 answered the medium used for communication. Four respondents emphasized the importance of behavioral changes as an outcome of message transmissions with the intention of risk minimization.Figure 1

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