Abstract
Over the past decade, the annual meetings of national centres participating in the WHO Programme for International Drug Monitoring have increasingly included discussions on how to improve communication between national pharmacovigilance centres, patients, healthcare professionals, policy makers and the general public, with the aim of promoting the safe use of medicines. At the most recent meetings, working groups were dedicated to discuss possible applications and implementation of social marketing and patient-tailored approaches. This article provides the history and a summary of the recent discussions and recommendations to support progress in this respect at national and global level. Recommendations are made to investigate and pilot these approaches in small-scale projects at national pharmacovigilance centres. Applying elements from the social marketing and patient-tailored approaches to support behaviours of safe medicines use in patients and healthcare professionals should give the pharmacovigilance community new tools to achieve their goal to minimize risks with medicines and improve patient safety.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
The future is now: current concepts in risk management [topical edition]. Drug Saf 2004; 27: 489–617
US Food and Drug and Administration. Guidance for industry: development and use of risk minimization action plans. Rockville (MD): Food and Drug Administration, 2005
European Medicines Agency. Guideline on risk management systems for medicinal product for human use. London: European Medicines Agency, 2005 (since then revised and included in ref. [4])
European Commission. Volume 9A of the Rules Governing Medicinal Products in the European Union: guidelines on pharmacovigilance for medicinal products for human use (revised 2008). Bruxelles: European Commission, 2007
US Food and Drug and Administration. Guidance for industry: format and content of proposed risk evaluation and mitigation strategies (REMS), REMS assessments, and proposed REMS modifications [draft]. Silver Spring (MD): Food and Drug Administration, 2009
Muehlberger N, Schneeweiss S, Hasford J. Adverse drug reaction monitoring: cost and benefit considerations. Part I: frequency of adverse drug reactions causing hospital admissions. Pharmacoepidemiol Drug Saf 1997; Suppl. 3: S71–7
Goettler M, Schneeweiss S, Hasford J. Adverse drug reaction monitoring: cost and benefit considerations. Part II: cost and preventability of adverse drug reactions leading to hospital admission. Pharmacoepidemiol Drug Saf 1997; Suppl 3: S79–90
Pouyanne P, Haramburu F, Imbs JL, et al. Admissions to hospital caused by adverse drug reactions: cross-sectional incidence study. BMJ 2000; 320: 1036
Phillips J, Beam S, Brinker A, et al. Retrospective analysis of mortalities associated with medication errors. Am J Health System Pharm 2001; 58: 1835–41
Beijer HJM, Blaey de CJ. Hospitalisations caused by adverse reactions (ADR): a meta-analysis of observational studies. Pharm World Sci 2002; 24: 46–54
Institute of Medicine of the National Academies (IOM). Preventing medication errors. Washington, DC: National Academies Press, 2006
Howard RL, Avery AJ, Slavenburg S, et al. Which drugs cause preventable admissions to hospital? A systematic review. Br J Clin Pharmacol 2006; 63: 136–47
Council of Europe Expert Group on Safe Medication Practices. Creation of a better medication safety culture in Europe: building up safe medication practices. Strasbourg: Council of Europe, 2007
Leendertse AJ, Egberts ACG, Stoker LJ, et al., For the HARM study group. Frequency of and risk factors for preventable medication-related hospital admissions in the Netherlands. Arch Intern Med 2008; 168: 1890–6
Hakkarainen KM, Hedna K, Petzold M, et al. Percentage of patients with preventable adverse drug reactions and preventability of adverse drug reactions: a meta-analysis. PLOS One 2012; 7: e33236, 1-9
World Health Organization. Pharmacovigilance [online]. Available from URL: http://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/index.html [Accessed 2011 Aug 11]
Furedi A. The public health implications of the 1995 “pill scare”. Hum Reprod Update 1999; 5: 621–6
Kotler P, Roberto N, Lee N. Social marketing: improving the quality of life. Thousands Oaks (CA): Sage, 2002
World Health Organization. The importance of pharmacovigilance. Geneva: World Health Organization, 2002
Pharmaceuticals and Medical Devices Agency. Automobile accidents associated with the use of smoking cessation aid CHAMPIX (varenicline tartrate) [PDMA request for proper use of drugs]. Tokyo: Pharmaceuticals and Medical Devices Agency, 2011 Oct 2 [online]. Available from URL: http://www.pmda.go.jp/english/service/pdf/request/No2.pdf [Accessed 2012 Jan 24]
Medicines and Healthcare products Regulatory Agency. Public consultation (MLX 364): the regulation of nicotine containing products (NCPs). London: Medicines and Healthcare products Regulatory Agency (last modified 9 March 2011) [online]. Available from URL: http://www.mhra.gov.uk/Publications/Consultations/Medicinesconsultations/MLXs/CON065617 [Accessed 2012 Jan 24]
Kutner M, Greenberg E, Jin Y, et al. The health literacy of American adults: results from the 2003 National Assessment of Adult Literacy. Washington, DC: US Department of Education, 2006
World Health Organization. Thirty-third annual meeting of representatives of national centres participating in the WHO Programme for International Drug Monitoring, 1–3 November 2010. WHO Pharmaceuticals Newsletter 2010; 6: 8–11
World Health Organization. Thirty-fourth annual meeting of representatives of national centres participating in the WHO Programme for International Drug Monitoring 30 October–2 November 2011. WHO Pharmaceuticals Newsletter 2012; 1: 25–7
Tadin J, MacolićŠarinić V. Communicating safety issues: the Croatian experience. Uppsala Reports 2012; 57: 15
Acknowledgements
The 2010 session was facilitated by M. Harrison-Woolrych and Y.K. Gupta (All India Institute of Medical Sciences), with P. Bahri acting as rapporteur. The 2011 session was facilitated by P. Bahri. The authors thank all participants of the working groups for the discussions, as well as Y.K. Gupta and K. Hartigan-Go for the review of the manuscript and S. N. Pal (WHO) for her comments on the draft. Thanks are also conveyed to K. Hartigan-Go for providing his thoughts on global awareness of drug safety presented to the WHO ASCoMP in 2009, which were used as the background for the 2010 session. During the review phase, the authors became aware of the leading role of M. Couper (WHO) in initiating discussions on social marketing of medicines safety at the level of ASCoMP, and engaging K. Hartigan-Go, with contribution from B. Hugman (Uppsala Monitoring Centre, the WHO Collaborating Centre for International Drug Monitoring), to draft an advocacy document for discussion by ASCoMP in 2007.
The views expressed in this article present a summary of the discussions at the annual meetings as perceived by the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the WHO or any of the organizations the authors are affiliated to. No sources of funding were used to prepare this article and the authors have no conflicts of interest to declare.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Bahri, P., Harrison-Woolrych, M. How to Improve Communication for the Safe Use of Medicines?. Drug Saf 35, 1073–1079 (2012). https://doi.org/10.1007/BF03261993
Published:
Issue Date:
DOI: https://doi.org/10.1007/BF03261993