An Industry Perspective on the Erice Declaration and Risk Minimisation Plans

Ingate, Simon; Tranter, D.; Banerjee, Anjan K.; Hobbs, Andrew

doi:10.2165/00002018-200629080-00010

Cited by 4 publications

(2 citation statements)

References 3 publications

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“…We have produced nearly 30 risk minimization plans to permit the safer use of medicines by patients and to enhance the benefit to risk ratio. 2 We have appreciated for some time that many of the most effective risk minimization measures for new medicines are centered around the activities of the pharmacist and the relevant interface with both patients and prescribers. 3 Relevant tools can relate to pharmacist education and also to the role of pharmacist as educator, as well as prescriber restrictions based on the pharmacist acting as a gatekeeper for access.…”

Section: Health Care Reformmentioning

confidence: 99%

Population-Based Surveillance of Infectious Endocarditis in an Italian Region

Scudeller

Badano²,

Crapis³

et al. 2009

Arch Intern Med

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2008, there was wide support for tight glucose control. The impact of these new data on clinical practice has yet to be determined. Studies such as Steno-2 10 that highlight the mortality benefit of aggressive hypertension and cholesterol control, along with our data, should encourage a renewed emphasis of their control among patients with diabetes. Between 1999-2000 and 2005-2006, improvements occurred in the control of hyperglycemia, hypertension, and high cholesterol level among US adults with diabetes. Also, there was increasingly aggressive medication use with substantially more combination therapy in antidiabetes medications and use of newer agents. The data from this study support the perception that control of hyperglycemia frequently takes precedence over control of hypertension and high cholesterol level among adults with diabetes. These observations support the argument for a reprioritization of diabetes treatment goals emphasizing hypertension and cholesterol control before tight glycemic control as part of an evidence-based global CVD risk reduction effort.

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Section: Health Care Reformmentioning

confidence: 99%

Population-Based Surveillance of Infectious Endocarditis in an Italian Region

Scudeller

Badano²,

Crapis³

et al. 2009

Arch Intern Med

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“…Additionally, despite the fact that drugs require administration into patients’ bodies under the direction of practitioners to exert their efficacy, transparency is somewhat compromised for both patients and healthcare professionals with regard to the discussion over which risk information for medicinal products should be made publicly available, and when this information should be communicated, which in turn leads to public distrust to pharmaceutical companies (Olsen and Whalen 2009). The necessity of systematic investigation of safety risk communications carried out as part of the pharmacovigilance activities of pharmaceutical companies has long been recognized, but the number of reports appearing to date is markedly low (Giampaolo 2010; Ingate et al 2006). …”

Section: Introductionmentioning

confidence: 99%

Pharmaceutical company perspectives on current safety risk communications in Japan

Urushihara

Kobashi²,

Masuda³

et al. 2014

SpringerPlus

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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.

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Pharmacists Are Key to Enhancing Benefit Risk for Medicines

Banerjee¹

2009

Arch Intern Med

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An Industry Perspective on the Erice Declaration and Risk Minimisation Plans

Cited by 4 publications

References 3 publications

Population-Based Surveillance of Infectious Endocarditis in an Italian Region

Population-Based Surveillance of Infectious Endocarditis in an Italian Region

Pharmaceutical company perspectives on current safety risk communications in Japan

Pharmacists Are Key to Enhancing Benefit Risk for Medicines

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