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Broadening the Scope of Pharmacovigilance

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Book cover Pharmacovigilance

Abstract

Over the past years, the scope of pharmacovigilance widened, allowing for better adjusted information on adverse drug reactions (ADRs) to the needs of regulators, clinicians and patients.

For treatment and managing the ADRs, not only is information on their clinical aspects important but also information characterising our attitude and behaviour towards ADRs. For healthcare professionals as well as patients, this information is vital for optimising treatment. Unfortunately, many of the methods used in pharmacovigilance are still focused on the detection of unknown serious and often rare events but not on extending our knowledge of the known, more common but often burdensome ADRs encountered by patients. To do this, pharmacovigilance should make a shift from the focus on finding new, previously unknown associations and elucidating the frequency of events to the analysis of the content and meaning of ADRs for both healthcare professionals and patients. This also implies a shift from population- and regulation-based pharmacovigilance to a patient-centred pharmacovigilance.

The discrepancy between the way the rules and regulations are often being implemented and the needs of patients and healthcare professionals is a point of concern. In this article we describe the way the concepts of pharmacovigilance have developed over time, the current playground of pharmacovigilance, the influence of modern day’s rules and regulations and possible ways to overcome the existing gap between the need for information of ADRs taking different stakeholders’ perspectives into account and its availability and usefulness in daily practice.

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References

  1. The importance of pharmacovigilance. (Safety monitoring of medicinal products) (2002) World Health Organisation

    Google Scholar 

  2. European Commission (2001) Directive 2001/83/EC of the European Parliament and of the Council

    Google Scholar 

  3. CIOMS (2010) Practical aspects of signal detection in pharmacovigilance. Report of CIOMS Working Group VIII. CIOMS, Geneva

    Google Scholar 

  4. The Erice Manifesto: for global reform of the safety of medicines in patient care (2007) Drug Saf 30(3):187–190

    Google Scholar 

  5. Borg JJ, Aislaitner G, Pirozynski M, Mifsud S (2011) Strengthening and rationalizing pharmacovigilance in the EU: where is Europe heading to? A review of the new EU legislation on pharmacovigilance. Drug Saf 34(3):187–197

    Article  PubMed  Google Scholar 

  6. European Medicines Agency (2015) Guideline on good pharmacovigilance practices (GVP) module VI – Management and reporting of adverse reactions to medicinal products. London. Report No.: EMA/873138/2011

    Google Scholar 

  7. Uppsala Monitoring Centre (2015) Reporting Trends. 22 Oct 2015

    Google Scholar 

  8. Substantial increase in ADR reports on Eudravigilance (2014) Reactions Weekly 1501(1):1

    Google Scholar 

  9. Ajzen I, Fishbein M (1980) Understanding attitudes and predicting social behavior. Prentice Hall, Englewood Cliffs

    Google Scholar 

  10. FDA (2009) Guidance for industry, patient-reported outcome measures: use in medical product development to support labeling claims

    Google Scholar 

  11. Golomb BA, McGraw JJ, Evans MA, Dimsdale JE (2007) Physician response to patient reports of adverse drug effects: implications for patient-targeted adverse effect surveillance. Drug Saf 30(8):669–675

    Article  PubMed  Google Scholar 

  12. van Hunsel F, Passier A, van Grootheest K (2009) Comparing patients’ and healthcare professionals’ ADR reports after media attention: the broadcast of a Dutch television programme about the benefits and risks of statins as an example. Br J Clin Pharmacol 67(5):558–564

    Article  PubMed  PubMed Central  Google Scholar 

  13. Medawar C, Herxheimer A, Bell A (2002) Paroxetine, Panorama and user reporting of ADRs: consumer intelligence matters in clinical practice and post-marketing drug surveillance. Int J Risk Saf Med 15:161–169

    Google Scholar 

  14. Medawar C, Herxheimer A (2004) A comparison of adverse drug reaction reports from professionals and users, relating to risk of dependence and suicidal behaviour with paroxetine. Int J Saf Med 16:5–19

    Google Scholar 

  15. Avery AJ, Anderson C, Bond CM, Fortnum H, Gifford A, Hannaford PC et al (2011) Evaluation of patient reporting of adverse drug reactions to the UK ‘Yellow Card Scheme’: literature review, descriptive and qualitative analyses, and questionnaire surveys. Health Technol Assess 15(20):1–iv

    Article  CAS  PubMed  Google Scholar 

  16. Rolfes L, van Hunsel F, Wilkes S, van Grootheest K, van Puijenbroek E (2015) Adverse drug reaction reports of patients and healthcare professionals-differences in reported information. Pharmacoepidemiol Drug Saf 24(2):152–158

    Article  PubMed  Google Scholar 

  17. Blenkinsopp A, Wilkie P, Wang M, Routledge PA (2007) Patient reporting of suspected adverse drug reactions: a review of published literature and international experience. Br J Clin Pharmacol 63(2):148–156

    Article  CAS  PubMed  Google Scholar 

  18. van Hunsel F, van der Welle C, Passier A, van Puijenbroek E, van Grootheest K (2010) Motives for reporting adverse drug reactions by patient-reporters in the Netherlands. Eur J Clin Pharmacol 66(11):1143–1150

    Article  PubMed  PubMed Central  Google Scholar 

  19. Frankenfeld C (2004) “Serious” and “severe” adverse drug reactions need defining. BMJ 329(7465):573

    Article  PubMed  PubMed Central  Google Scholar 

  20. de Langen J, van Hunsel F, Passier A, de Jong-van den Berg L, van Grootheest K (2008) Adverse drug reaction reporting by patients in the Netherlands: three years of experience. Drug Saf 31(6):515–524

    Article  PubMed  Google Scholar 

  21. Hazell L, Cornelius V, Hannaford P, Shakir S, Avery AJ (2013) How do patients contribute to signal detection?: A retrospective analysis of spontaneous reporting of adverse drug reactions in the UK’s Yellow Card Scheme. Drug Saf 36(3):199–206

    Article  PubMed  Google Scholar 

  22. van Hunsel F, Talsma A, van Puijenbroek E, de Jong-van den Berg L, van Grootheest K (2011) The proportion of patient reports of suspected ADRs to signal detection in the Netherlands: case-control study. Pharmacoepidemiol Drug Saf 20(3):286–291

    Article  PubMed  Google Scholar 

  23. Lester J, Neyarapally GA, Lipowski E, Graham CF, Hall M, Dal PG (2013) Evaluation of FDA safety-related drug label changes in 2010. Pharmacoepidemiol Drug Saf 22(3):302–305

    Article  PubMed  Google Scholar 

  24. Harmark L, Puijenbroek E, Grootheest K (2011) Longitudinal monitoring of the safety of drugs by using a web-based system: the case of pregabalin. Pharmacoepidemiol Drug Saf 20(6):591–597

    Article  PubMed  Google Scholar 

  25. van Balveren-Slingerland L, Kant A, Harmark L (2015) Web-based intensive monitoring of adverse events following influenza vaccination in general practice. Vaccine 33(19):2283–2288

    Article  PubMed  Google Scholar 

  26. Sloane R, Osanlou O, Lewis D, Bollegala D, Maskell S, Pirmohamed M (2015) Social media and pharmacovigilance: a review of the opportunities and challenges. Br J Clin Pharmacol 80(4):910–920

    Article  PubMed  PubMed Central  Google Scholar 

  27. Bergvall T, Noren GN, Lindquist M (2014) vigiGrade: a tool to identify well-documented individual case reports and highlight systematic data quality issues. Drug Saf 37(1):65–77

    Article  PubMed  Google Scholar 

  28. Vandenbroucke JP (1998) Observational research and evidence-based medicine: what should we teach young physicians? J Clin Epidemiol 51(6):467–472

    Article  CAS  PubMed  Google Scholar 

  29. Vandenbroucke JP (2001) In defense of case reports and case series. Ann Intern Med 134(4):330–334

    Article  CAS  PubMed  Google Scholar 

  30. Viola E, Coggiola PA, Drahos A, Moretti U, Conforti A (2015) Photosensitivity with angiotensin II receptor blockers: a retrospective study using data from VigiBase((R)). Drug Saf 38(10):889–894

    Article  CAS  PubMed  Google Scholar 

  31. Hill AB (1965) The environment and disease: association or causation! Proc R Soc Med 58:295–300

    CAS  PubMed  PubMed Central  Google Scholar 

  32. van Puijenbroek EP, Broos N, van Grootheest K (2010) Monitoring adverse events of the vaccination campaign against influenza A (H1N1) in the Netherlands. Drug Saf 33(12):1097–1108

    Article  PubMed  Google Scholar 

  33. Mackay FJ (1998) Post-marketing studies: the work of the Drug Safety Research Unit. Drug Saf 19(5):343–353

    Article  CAS  PubMed  Google Scholar 

  34. Harrison-Woolrych M, Coulter DM. PEM in New Zealand. In: Mann R, Andrews E, eds. Pharmacovigilance. 2nd editon. John Wiley & Sons Ltd; Chichester, UK; 2007. p. 317–32

    Google Scholar 

  35. Shakir SA (2007) PEM in the UK. In: Mann R (ed) Pharmacovigilance. Wiley, Chichester, pp 307–316

    Google Scholar 

  36. Mol PG, Straus SM, Piening S, de Vries JT, de Graeff PA, Haaijer-Ruskamp FM (2010) A decade of safety-related regulatory action in the Netherlands: a retrospective analysis of direct healthcare professional communications from 1999 to 2009. Drug Saf 33(6):463–474

    Article  PubMed  Google Scholar 

  37. Piening S, Reber KC, Wieringa JE, Straus SM, de Graeff PA, Haaijer-Ruskamp FM et al (2012) Impact of safety-related regulatory action on drug use in ambulatory care in the Netherlands. Clin Pharmacol Ther 91(5):838–845

    Article  CAS  PubMed  Google Scholar 

  38. Reber KC, Piening S, Wieringa JE, Straus SM, Raine JM, de Graeff PA et al (2013) When direct health-care professional communications have an impact on inappropriate and unsafe use of medicines. Clin Pharmacol Ther 93(4):360–365

    Article  CAS  PubMed  Google Scholar 

  39. Piening S, de Graeff PA, Straus SM, Haaijer-Ruskamp FM, Mol PG (2013) The additional value of an e-mail to inform healthcare professionals of a drug safety issue: a randomized controlled trial in the Netherlands. Drug Saf 36(9):723–731

    Article  PubMed  Google Scholar 

  40. Raynor DK, Blenkinsopp A, Knapp P, Grime J, Nicolson DJ, Pollock K et al (2007) A systematic review of quantitative and qualitative research on the role and effectiveness of written information available to patients about individual medicines. Health Technol Assess 11(5):iii1–iii160

    Article  Google Scholar 

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Author information

Authors and Affiliations

  1. Netherlands Pharmacovigilance Centre Lareb, ’s-Hertogenbosch, The Netherlands

    Eugène P. van Puijenbroek & Linda Harmark

Authors
  1. Eugène P. van Puijenbroek
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  2. Linda Harmark
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Corresponding author

Correspondence to Eugène P. van Puijenbroek .

Editor information

Editors and Affiliations

  1. Uppsala Monitoring Centre, Uppsala, Sweden

    I. Ralph Edwards

  2. Uppsala Monitoring Centre, Uppsala, Sweden

    Marie Lindquist

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van Puijenbroek, E.P., Harmark, L. (2017). Broadening the Scope of Pharmacovigilance. In: Edwards, I., Lindquist, M. (eds) Pharmacovigilance. Adis, Cham. https://doi.org/10.1007/978-3-319-40400-4_13

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  • DOI: https://doi.org/10.1007/978-3-319-40400-4_13

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  • Publisher Name: Adis, Cham

  • Print ISBN: 978-3-319-40399-1

  • Online ISBN: 978-3-319-40400-4

  • eBook Packages: MedicineMedicine (R0)

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