Skip to main content
Top
Published in: Drug Safety 7/2015

01-07-2015 | From the ISoP

The ISoP CommSIG for Improving Medicinal Product Risk Communication: A New Special Interest Group of the International Society of Pharmacovigilance

Authors: Priya Bahri, Alexander N. Dodoo, Brian D. Edwards, I. Ralph Edwards, Irene Fermont, Ulrich Hagemann, Kenneth Hartigan-Go, Bruce Hugman, Peter G. Mol

Published in: Drug Safety | Issue 7/2015

Login to get access

Excerpt

Communicating to patients and healthcare providers about the risks of harm with medicines and how to use medicines safely is vital to pharmacovigilance for fulfilling its objectives—there is no or little risk avoidance/mitigation or patient safety without risk communication. Communication about risk characteristics and factors should also enable patients and healthcare providers to make informed therapeutic choices. This requires discussing risks of medicines in the context of their benefits as well as the risks of deciding against medication. Usually medicines are meant to benefit the individuals taking them. In the area of infectious diseases, however, vaccines are aimed at protecting the vaccinee and also, through repressing or eradicating the disease, protecting vulnerable individuals who cannot be vaccinated. …
Appendix
Available only for authorised users
Literature
1.
go back to reference Effective communication in pharmacovigilance: the Erice report. Uppsala: Uppsala Monitoring Centre (UMC); 1997. (Report on the International Conference on Developing Effective Communications in Pharmacovigilance held in Erice, 24–27 September 1997, organised by the UMC, the World Health Organization (WHO), the University of Verona, the International School of Pharmacology at the Ettore Majorana Foundation and Centre for Scientific Culture in Erice, Sicily, Italy and supported by EQUUS Communications, UK). Effective communication in pharmacovigilance: the Erice report. Uppsala: Uppsala Monitoring Centre (UMC); 1997. (Report on the International Conference on Developing Effective Communications in Pharmacovigilance held in Erice, 24–27 September 1997, organised by the UMC, the World Health Organization (WHO), the University of Verona, the International School of Pharmacology at the Ettore Majorana Foundation and Centre for Scientific Culture in Erice, Sicily, Italy and supported by EQUUS Communications, UK).
2.
go back to reference Erice statement 2009: communication, medicines and patient safety. Br J Clin Pharmacol. 2010; 69: 207–208. (Statement from the Workshop on Drug Risk Communication held in Erice, 3–8 July 2009, organised by the International School of Pharmacology at the Ettore Majorana Foundation and Centre for Scientific Culture in Erice, Sicily, Italy, in collaboration with the International Society of Pharmacovigilance (ISoP), the SK Foundation and the Uppsala Monitoring Centre (UMC)). Erice statement 2009: communication, medicines and patient safety. Br J Clin Pharmacol. 2010; 69: 207–208. (Statement from the Workshop on Drug Risk Communication held in Erice, 3–8 July 2009, organised by the International School of Pharmacology at the Ettore Majorana Foundation and Centre for Scientific Culture in Erice, Sicily, Italy, in collaboration with the International Society of Pharmacovigilance (ISoP), the SK Foundation and the Uppsala Monitoring Centre (UMC)).
3.
go back to reference Uppsala Monitoring Centre (UMC). Dialogue in pharmacovigilance. Uppsala: UMC; 2002. (Based on preliminary meeting organised by the UMC, the Department of Clinical Pharmacology of the University of Verona and EQUUS Communications, UK and sponsored by the World Health Organization (WHO) and the Council for International Organizations for Medical Sciences (CIOMS)). Uppsala Monitoring Centre (UMC). Dialogue in pharmacovigilance. Uppsala: UMC; 2002. (Based on preliminary meeting organised by the UMC, the Department of Clinical Pharmacology of the University of Verona and EQUUS Communications, UK and sponsored by the World Health Organization (WHO) and the Council for International Organizations for Medical Sciences (CIOMS)).
4.
go back to reference Uppsala Monitoring Centre (UMC). Expecting the worst: anticipating, preventing and managing medicinal product and other healthcare crises. 2nd ed. Uppsala: UMC; 2010. Uppsala Monitoring Centre (UMC). Expecting the worst: anticipating, preventing and managing medicinal product and other healthcare crises. 2nd ed. Uppsala: UMC; 2010.
7.
go back to reference Fischhoff B, Brewer NT, Downs JS. Communicating risks and benefits: an evidence-based user’s guide. Silver Spring: US Food and Drug Administration; 2009. Fischhoff B, Brewer NT, Downs JS. Communicating risks and benefits: an evidence-based user’s guide. Silver Spring: US Food and Drug Administration; 2009.
8.
go back to reference US Food and Drug Administration. Guidance on drug safety information: FDA’s communication to the public (2007), Guidance for industry and FDA staff: dear health care provider letters: improving communication of important safety information (2014) and Guidance for industry: internet/social media platforms with character space limitations: presenting risk and benefit information for prescription drugs and medical devices [draft] (2014) on: Guidances (drugs) [webpage]. Silver Spring: 2015. Available under: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. US Food and Drug Administration. Guidance on drug safety information: FDA’s communication to the public (2007), Guidance for industry and FDA staff: dear health care provider letters: improving communication of important safety information (2014) and Guidance for industry: internet/social media platforms with character space limitations: presenting risk and benefit information for prescription drugs and medical devices [draft] (2014) on: Guidances (drugs) [webpage]. Silver Spring: 2015. Available under: http://​www.​fda.​gov/​Drugs/​GuidanceComplian​ceRegulatoryInfo​rmation/​Guidances/​default.​htm.
10.
go back to reference Cox AR, Butt TF. Adverse drug reactions: when the risk becomes a reality for patients. Drug Saf. 2012;35:977–81.PubMedCrossRef Cox AR, Butt TF. Adverse drug reactions: when the risk becomes a reality for patients. Drug Saf. 2012;35:977–81.PubMedCrossRef
11.
go back to reference Fischhoff B. Good decision making requires good communication. Drug Saf. 2012;35:983–93.PubMed Fischhoff B. Good decision making requires good communication. Drug Saf. 2012;35:983–93.PubMed
12.
go back to reference Hartigan-Go K. Challenges of drug risk communication in the Philippines. Drug Saf. 2012;35:995–1004.PubMed Hartigan-Go K. Challenges of drug risk communication in the Philippines. Drug Saf. 2012;35:995–1004.PubMed
13.
go back to reference Hugman B. Protecting the people? Risk communication and the chequered history and performance of bureaucracy. Drug Saf. 2012;35:1005–25.PubMedCrossRef Hugman B. Protecting the people? Risk communication and the chequered history and performance of bureaucracy. Drug Saf. 2012;35:1005–25.PubMedCrossRef
14.
go back to reference Edwards B, Chakraborty S. Risk communication and the pharmaceutical industry: what is the reality. Drug Saf. 2012;35:1027–40.PubMedCrossRef Edwards B, Chakraborty S. Risk communication and the pharmaceutical industry: what is the reality. Drug Saf. 2012;35:1027–40.PubMedCrossRef
15.
go back to reference Dodoo A, Hugman B. Risk perception and communication in Sub-Saharan Africa. Drug Saf. 2012;35:1041–52.PubMed Dodoo A, Hugman B. Risk perception and communication in Sub-Saharan Africa. Drug Saf. 2012;35:1041–52.PubMed
16.
go back to reference Larson H, Brocard Paterson P, Erondu N. The globalisation of risk and risk perception: why we need a new model of risk communication for vaccines. Drug Saf. 2012;35:1053–9.PubMedCrossRef Larson H, Brocard Paterson P, Erondu N. The globalisation of risk and risk perception: why we need a new model of risk communication for vaccines. Drug Saf. 2012;35:1053–9.PubMedCrossRef
17.
go back to reference Piening S, Haaijer-Ruskamp FM, de Graeff PA, Straus SMJM, Mol PGM. Healthcare professionals’ self-reported experiences and preferences related to direct healthcare professional communications: a survey conducted in the Netherlands. Drug Saf. 2012;35:1061–72.PubMed Piening S, Haaijer-Ruskamp FM, de Graeff PA, Straus SMJM, Mol PGM. Healthcare professionals’ self-reported experiences and preferences related to direct healthcare professional communications: a survey conducted in the Netherlands. Drug Saf. 2012;35:1061–72.PubMed
18.
go back to reference Castot A. EU guidance on the handling of direct healthcare professional communications (DHPCs) on the safe and effective use of medicinal products for human use [training lecture]. In: Liège: 6th Annual Meeting of the International Society of Pharmacovigilance; 10 October 2006. Castot A. EU guidance on the handling of direct healthcare professional communications (DHPCs) on the safe and effective use of medicinal products for human use [training lecture]. In: Liège: 6th Annual Meeting of the International Society of Pharmacovigilance; 10 October 2006.
19.
go back to reference Schmickler M. How to prevent side effects: communicating risks to health professionals [training lecture]. In: Liège: 6th annual meeting of the international society of pharmacovigilance; 10 October 2006. Schmickler M. How to prevent side effects: communicating risks to health professionals [training lecture]. In: Liège: 6th annual meeting of the international society of pharmacovigilance; 10 October 2006.
20.
go back to reference Fermont I. How to built a new partnership aimed at risk communication [training lecture]. In: Liège: 6th annual meeting of the international society of pharmacovigilance; 10 October 2006. Fermont I. How to built a new partnership aimed at risk communication [training lecture]. In: Liège: 6th annual meeting of the international society of pharmacovigilance; 10 October 2006.
21.
go back to reference Stather R. Communicating drug safety: the role of the specialist journal [presentation]. In: Bournemouth: 7th annual meeting of the international society of pharmacovigilance; 24 October 2007. Stather R. Communicating drug safety: the role of the specialist journal [presentation]. In: Bournemouth: 7th annual meeting of the international society of pharmacovigilance; 24 October 2007.
22.
go back to reference Jones G. Communicating drug safety: the role of medical journals [presentation]. In: Bournemouth: 7th annual meeting of the international society of pharmacovigilance; 24 October 2007. Jones G. Communicating drug safety: the role of medical journals [presentation]. In: Bournemouth: 7th annual meeting of the international society of pharmacovigilance; 24 October 2007.
23.
go back to reference Abbasi K. Communicating drug safety: the role of the editor of a medical journal [presentation]. In: Bournemouth: 7th annual meeting of the international society of pharmacovigilance; 24 October 2007. Abbasi K. Communicating drug safety: the role of the editor of a medical journal [presentation]. In: Bournemouth: 7th annual meeting of the international society of pharmacovigilance; 24 October 2007.
24.
go back to reference Bahri P. Public pharmacovigilance communication: a process calling for evidence-based, objective-driven strategies. Drug Saf. 2010;33:1065–79.PubMedCrossRef Bahri P. Public pharmacovigilance communication: a process calling for evidence-based, objective-driven strategies. Drug Saf. 2010;33:1065–79.PubMedCrossRef
25.
go back to reference Castot A. Communication from regulatory authorities in the EU: current challenges and developments [presentation]. In: Reims: 9th annual meeting of the international society of pharmacovigilance; 7 October 2009. Castot A. Communication from regulatory authorities in the EU: current challenges and developments [presentation]. In: Reims: 9th annual meeting of the international society of pharmacovigilance; 7 October 2009.
26.
go back to reference Le Louet H. Patient reporting of adverse drug reactions and cooperation with patient associations: a pilot study [presentation]. In: Reims: 9th Annual Meeting of the International Society of Pharmacovigilance; 7 October 2009. Le Louet H. Patient reporting of adverse drug reactions and cooperation with patient associations: a pilot study [presentation]. In: Reims: 9th Annual Meeting of the International Society of Pharmacovigilance; 7 October 2009.
27.
go back to reference Kouimtzi M. Risks of evidence-based medicine and effective communication [presentation]. In: Reims: 9th Annual Meeting of the International Society of Pharmacovigilance; 7 October 2009. Kouimtzi M. Risks of evidence-based medicine and effective communication [presentation]. In: Reims: 9th Annual Meeting of the International Society of Pharmacovigilance; 7 October 2009.
28.
go back to reference Turone F. The media between alarmist headlines and confident declarations [presentation]. In: Reims: 9th Annual Meeting of the International Society of Pharmacovigilance; 7 October 2009. Turone F. The media between alarmist headlines and confident declarations [presentation]. In: Reims: 9th Annual Meeting of the International Society of Pharmacovigilance; 7 October 2009.
29.
go back to reference Fainzang S. Pharmacovigilance and patients: symbolic logics and ethical aspects [abstract]. Drug Saf. 2009;32:988. Fainzang S. Pharmacovigilance and patients: symbolic logics and ethical aspects [abstract]. Drug Saf. 2009;32:988.
30.
go back to reference Bahri P, Mol PGM, Théophile H, Edwards IR, Hugman BPJ. Communication in drug safety: a report from an interactive debate held at the 10th annual meeting of the International Society of Pharmacovigilance (ISoP), 2010. Drug Saf. 2011;34:881–2.PubMedCrossRef Bahri P, Mol PGM, Théophile H, Edwards IR, Hugman BPJ. Communication in drug safety: a report from an interactive debate held at the 10th annual meeting of the International Society of Pharmacovigilance (ISoP), 2010. Drug Saf. 2011;34:881–2.PubMedCrossRef
31.
go back to reference Osborne V, Layton D, Al Shukri M, Foff C, Shakir S. Indicators of dependence and aberrant behaviours during post-marketing use of fentanyl buccal tablets: risk scores in support of risk management [abstract]. Drug Saf. 2011;34:895. Osborne V, Layton D, Al Shukri M, Foff C, Shakir S. Indicators of dependence and aberrant behaviours during post-marketing use of fentanyl buccal tablets: risk scores in support of risk management [abstract]. Drug Saf. 2011;34:895.
32.
go back to reference Arnardottir A, Haaijer Ruskamp F, Straus S, Piening S, Monster Simons M, De Graeff P, Mol P. Which aspects of new glucose lowering drugs do different stakeholders value? A qualitative study [abstract]. Drug Saf. 2011;34:896.CrossRef Arnardottir A, Haaijer Ruskamp F, Straus S, Piening S, Monster Simons M, De Graeff P, Mol P. Which aspects of new glucose lowering drugs do different stakeholders value? A qualitative study [abstract]. Drug Saf. 2011;34:896.CrossRef
33.
go back to reference Bahri P. Patients, medicines and perceptions: “bridging continents” for improving risk assessment and communication [abstract]. Drug Saf. 2011;34:896.CrossRef Bahri P. Patients, medicines and perceptions: “bridging continents” for improving risk assessment and communication [abstract]. Drug Saf. 2011;34:896.CrossRef
34.
go back to reference Lofstedt R. Perception of risk and communication [lecture]. In: Istanbul: 11th Annual Meeting of the International Society of Pharmacovigilance; 28 October 2011. Lofstedt R. Perception of risk and communication [lecture]. In: Istanbul: 11th Annual Meeting of the International Society of Pharmacovigilance; 28 October 2011.
35.
go back to reference Stefansdottir G, Knol MJ, Leufkens HG, Arnardottir AH, Grobbee DE, De Bruin ML. Room for improvement in safety learning of same class drugs [abstract]. Drug Saf. 2011;34:892.CrossRef Stefansdottir G, Knol MJ, Leufkens HG, Arnardottir AH, Grobbee DE, De Bruin ML. Room for improvement in safety learning of same class drugs [abstract]. Drug Saf. 2011;34:892.CrossRef
36.
go back to reference Butt TF, Cox AR, Oyebode J, Ferner RE. Internet accounts of survivors of serious adverse drug reactions: a study of experiences of Stevens-Johnson syndrome and toxic epidermal necrolysis. Drug Saf. 2012;35:1159–70.PubMedCrossRef Butt TF, Cox AR, Oyebode J, Ferner RE. Internet accounts of survivors of serious adverse drug reactions: a study of experiences of Stevens-Johnson syndrome and toxic epidermal necrolysis. Drug Saf. 2012;35:1159–70.PubMedCrossRef
37.
go back to reference Psaty B. The rhetoric of risk communications: rosiglitazone and its aftermath in the US [presentation]. In: Cancun: 12th Annual Meeting of the International Society of Pharmacovigilance; 2 November 2012. Psaty B. The rhetoric of risk communications: rosiglitazone and its aftermath in the US [presentation]. In: Cancun: 12th Annual Meeting of the International Society of Pharmacovigilance; 2 November 2012.
38.
go back to reference Van Puijenbroek EP, Abbink NH, Van Grootheest AC. Perception of causality terms: a personal view [abstract]. Drug Saf. 2012;35:888. Van Puijenbroek EP, Abbink NH, Van Grootheest AC. Perception of causality terms: a personal view [abstract]. Drug Saf. 2012;35:888.
39.
go back to reference Tulkens PM, Arvis P, Kruesmann F. Communicating comprehensive safety data gained from clinical trials to the scientific community: opportunities and difficulties from an example with moxifloxacin [abstract]. Drug Saf. 2012;35:888. Tulkens PM, Arvis P, Kruesmann F. Communicating comprehensive safety data gained from clinical trials to the scientific community: opportunities and difficulties from an example with moxifloxacin [abstract]. Drug Saf. 2012;35:888.
40.
go back to reference Piening S, Reber KC, Wieringa JE, Straus SM, De Graeff PA, Haaijer-Ruskamp FM, Mol PGM. Determinants of impact of drug safety warnings: a retropespective analysis of direct healthcare professional communications [abstract]. Drug Saf. 2012;35:913. Piening S, Reber KC, Wieringa JE, Straus SM, De Graeff PA, Haaijer-Ruskamp FM, Mol PGM. Determinants of impact of drug safety warnings: a retropespective analysis of direct healthcare professional communications [abstract]. Drug Saf. 2012;35:913.
41.
go back to reference Bahri P. The relationship between pharmacovigilance and the various media types: increasing mutual understanding [abstract]. Drug Saf. 2013;36:939. Bahri P. The relationship between pharmacovigilance and the various media types: increasing mutual understanding [abstract]. Drug Saf. 2013;36:939.
42.
go back to reference Feinmann J. Risks of medicines and the media [oral comments]. In: Rome: 13th Annual Meeting of the International Society of Pharmacovigilance; 4 October 2013. Feinmann J. Risks of medicines and the media [oral comments]. In: Rome: 13th Annual Meeting of the International Society of Pharmacovigilance; 4 October 2013.
43.
go back to reference Radawski C, Morrato E, Hornbuckle K, Bahri P, Smith M, Juhaeri J, Mol P, Levitan B, Huang H-Y, Coplan P, Li H, on behalf of the BRACE Special Interest Group. Benefit-risk assessment, communication and evaluation (BRACE) throughout the life cycle of therapeutic products: overall perspective and role of the pharmacoepidemiologist. Pharmacoepidemiol Drug Saf. 2015. (Submitted). https://pharmacoepi.org/communities/BRACE.cfm Radawski C, Morrato E, Hornbuckle K, Bahri P, Smith M, Juhaeri J, Mol P, Levitan B, Huang H-Y, Coplan P, Li H, on behalf of the BRACE Special Interest Group. Benefit-risk assessment, communication and evaluation (BRACE) throughout the life cycle of therapeutic products: overall perspective and role of the pharmacoepidemiologist. Pharmacoepidemiol Drug Saf. 2015. (Submitted). https://​pharmacoepi.​org/​communities/​BRACE.​cfm
44.
go back to reference International Society of Pharmacovigilance (ISoP). In: 14th Annual Meeting of the International Society of Pharmacovigilance: new ideas in ancient cultures: advancing pharmacovigilance in Asia [conference programme]. 20–22 October 2014. Available under: http://www.isop2014.org/plan.aspx. International Society of Pharmacovigilance (ISoP). In: 14th Annual Meeting of the International Society of Pharmacovigilance: new ideas in ancient cultures: advancing pharmacovigilance in Asia [conference programme]. 20–22 October 2014. Available under: http://​www.​isop2014.​org/​plan.​aspx.
46.
go back to reference Arvai J, Rivers L III. Effective risk communication. London: Earthscan; 2013. Arvai J, Rivers L III. Effective risk communication. London: Earthscan; 2013.
47.
go back to reference Fischhoff B, Bostrom A, Jacobs Quadrel M. Risk perception and communication. In: Detels R, McEwen J, Reaglehole R, Tanaka H, editors. Oxford textbook of public health. 4th ed. Oxford: Oxford University Press; 2002. Fischhoff B, Bostrom A, Jacobs Quadrel M. Risk perception and communication. In: Detels R, McEwen J, Reaglehole R, Tanaka H, editors. Oxford textbook of public health. 4th ed. Oxford: Oxford University Press; 2002.
48.
go back to reference Lofstedt RE. Risk management in post-trust societies. London: Pelgrave Macmillan; 2005.CrossRef Lofstedt RE. Risk management in post-trust societies. London: Pelgrave Macmillan; 2005.CrossRef
49.
go back to reference Pidgeon N, Kasperson RE, Slovic P. The social amplification of risk. Cambridge: Cambridge University Press; 2003.CrossRef Pidgeon N, Kasperson RE, Slovic P. The social amplification of risk. Cambridge: Cambridge University Press; 2003.CrossRef
50.
go back to reference Siegrist M, Earle TC, Gutscher H. Trust in cooperative risk management: uncertainty and scepticism in the public mind. London: Earthscan; 2007. Siegrist M, Earle TC, Gutscher H. Trust in cooperative risk management: uncertainty and scepticism in the public mind. London: Earthscan; 2007.
51.
go back to reference Slovic P. Perception of risk. London: Earthscan; 2000. Slovic P. Perception of risk. London: Earthscan; 2000.
52.
go back to reference Beckmann J, Hagemann U, Bahri P, Bate A, Boyd IW, Dal Pan GJ, Edwards BD, Edwards IR, Hartigan-Go K, Lindquist M, McEwen J, Moride Y, Olsson S, Pal SN, Soulaymani-Bencheikh R, Tuccori M, Vaca CP, Wong ICK. Teaching pharmacovigilance: the WHO-ISoP core elements of a comprehensive modular curriculum. Drug Saf. 2014; 37: 743–759. Beckmann J, Hagemann U, Bahri P, Bate A, Boyd IW, Dal Pan GJ, Edwards BD, Edwards IR, Hartigan-Go K, Lindquist M, McEwen J, Moride Y, Olsson S, Pal SN, Soulaymani-Bencheikh R, Tuccori M, Vaca CP, Wong ICK. Teaching pharmacovigilance: the WHO-ISoP core elements of a comprehensive modular curriculum. Drug Saf. 2014; 37: 743–759.
54.
go back to reference International Society of Pharmacovigilance (ISoP). In: 15th Annual Meeting of the International Society of Pharmacovigilance: cubism in pharmacovigilance [conference programme]. 27–30 October 2015. Available under: http://www.isop2015prague.org. International Society of Pharmacovigilance (ISoP). In: 15th Annual Meeting of the International Society of Pharmacovigilance: cubism in pharmacovigilance [conference programme]. 27–30 October 2015. Available under: http://​www.​isop2015prague.​org.
Metadata
Title
The ISoP CommSIG for Improving Medicinal Product Risk Communication: A New Special Interest Group of the International Society of Pharmacovigilance
Authors
Priya Bahri
Alexander N. Dodoo
Brian D. Edwards
I. Ralph Edwards
Irene Fermont
Ulrich Hagemann
Kenneth Hartigan-Go
Bruce Hugman
Peter G. Mol
Publication date
01-07-2015
Publisher
Springer International Publishing
Published in
Drug Safety / Issue 7/2015
Print ISSN: 0114-5916
Electronic ISSN: 1179-1942
DOI
https://doi.org/10.1007/s40264-015-0301-0

Other articles of this Issue 7/2015

Drug Safety 7/2015 Go to the issue