Skip to main content
SpringerLink
Log in

Reporting of Adverse Drug Reactions by Community Pharmacists: A Qualitative Study in Quebec

  • Drug Information
  • Published:
Drug information journal : DIJ / Drug Information Association Aims and scope Submit manuscript

Abstract

We report on the findings of an original research initiative to explore current gaps that exist in the level of awareness and utilization of Canada’s adverse drug reaction (ADR) reporting system among community pharmacists. To understand the level of knowledge and practices related to ADR reporting, a survey was conducted among Quebec pharmacists. Nearly two thirds of respondents had reported at least one ADR in the past, but many did not recognize “lack of effectiveness” as an ADR and were unaware of the minimum requirements for ADR reporting. Events seen as “unexpected, rare, or serious” were most likely to be reported whereas “well-known or common” events or those with “uncertain causality” tended not to be reported. Regarding switching from brand name to generic formulation, two thirds reported that they did not perform special monitoring, yet the same proportion recalled a specific ADR associated with switching, particularly with Effexor XR (venlafaxine XR), Pantoloc (pantoprazole), and Concerta (methylphenidate-OROS). The majority of the current survey participants (Quebec pharmacists) are aware of the ADR reporting system, but underutilization exists.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. McGettigan P, Feely J. Adverse drug reaction reporting: opinions and attitudes of medical practitioners in Ireland. Pharmacoepidemiol Drug Saf. 1995;4:355–358

    Article  Google Scholar 

  2. Health Canada. Drugs and health products. Adverse reaction information, http://www.hc-sc.gc.ca/dhp-mps/medeff/advers-react-neg/index-eng.php#a1 (accessed September 7, 2010).

  3. MedEffect Program, www.hc-sc.gc.ca/dhp-mps/medeff/about-sujet-eng.php (accessed August 26, 2010).

  4. Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356:1255–1259

    Article  CAS  Google Scholar 

  5. Canada Vigilance Adverse Reaction Reporting. http://www.hc-sc.ca/dhp-mps/medeff/vigilance-eng.php (accessed August 26, 2010).

  6. National Association of Pharmacy Regulatory Authorities. Standards of practice for Canadian pharmacists. Pharm Connect. 2010;17(4):12–22

    Google Scholar 

  7. National Association of Pharmacy Regulatory Authorities. National statistics, http://napra.ca/ pages/Practice_Resources/National_Statistics.aspx?id=2103 (accessed January 14, 2011).

  8. National Association of Pharmacy Regulatory Authorities, http://napra.ca/pages/practice_resources/national_statistics_aspx?id=2104/ (accessed July 6, 2011).

  9. Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2009;32(1):19–31

    Article  CAS  Google Scholar 

  10. Hazell L, Shakir SA. Under reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29(5):385–396

    Article  Google Scholar 

  11. Motola D, Vargiu A, Leone R, et al. Influence of regulatory measures on the rate of spontaneous adverse drug reaction reporting in Italy. Drug Saf. 2008;31(7):609–616

    Article  CAS  Google Scholar 

  12. Health Canada. Adverse reaction reporting—survey with health professionals. May 2007. HC POR 06–93.

  13. van Grootheest K, Olsson S, Couper M, et al. Pharmacists’ role in reporting adverse drug reactions in an international perspective. Pharmacoepidemiol Drug Saf. 2004;13:457–464

    Article  Google Scholar 

  14. Canada Vigilance Adverse Reaction Reporting Program. Completion of form instructions. http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/medeff/report-declaration/ar-ei_form-eng.pdf (accessed August 26, 2010).

  15. Burkiewicz JS, Zgarrick DP. Evidence based practice by pharmacists: utilization and barriers. Ann Pharmacother. 2005;39:1214–1219

    Article  Google Scholar 

  16. Brown CM, Barner JC, Shepherd MD. Issues and barriers related to the provision of pharmaceutical care in community health centers and migrant health centers. J Am Pharm Assoc. 2003;43:75–77

    Article  Google Scholar 

  17. Nadaira N, Ouellet C, Rene-Henri N, et al. Factors influencing a community pharmacist’s interventions in asthma care. Can Pharmacists J. 2009;142(5):240–246

    Article  Google Scholar 

  18. Amsler MR, Murray MD, Tierney WM, et al. Pharmaceutical care in chain pharmacies: beliefs and attitudes of pharmacists and patients. J Am Pharm Assoc. 1997;37:535–542

    Google Scholar 

  19. Borgherini G. The bioequivalence and therapeutic efficacy of generic versus brand-name psychoactive drugs. Clin Ther. 2003;25(6):1578–1592

    Article  CAS  Google Scholar 

  20. Makus KG, McCormick J. Identification of adverse reactions that can occur on substitutions of generic for branded lamotrigine in patients with epilepsy. Clin Ther. 2007;29(2):334–341

    Article  CAS  Google Scholar 

  21. Chenu F, Batten LA, Zernig G, et al. Comparison of pharmacokinetic profiles of brand-name and generic formulations of citalopram and venlafaxine: a crossover study. J Clin Psychiatry. 2009;70:958–966

    Article  CAS  Google Scholar 

  22. Vial J, Cohen M, Sassiat P, et al. Pharmaceutical quality of docetaxel generics versus originator drug product: a comparative analysis. Curr Med Res Opin. 2008;24:2019–2033

    Article  CAS  Google Scholar 

  23. LeLorier J, Duh MS, Paradis PE, et al. Clinical consequences of generic substitution of lamotrigine for patients with epilepsy. Neurology. 2008;70:2179–2186

    Article  CAS  Google Scholar 

  24. Endrenyi L, Tothfalusi L. Do regulatory bioequivalence requirements adequately reflect the therapeutic equivalence of modified release drug products? J Pharm Pharmaceut Sci. 2010;13(1):107–113.

    CAS  Google Scholar 

  25. Andermann F, Duh MS, Gosselin A, et al. Compulsory generic switching of antiepileptic drugs: high switchback rates to branded compounds compared with other drug classes. Epilepsia. 2007;48(3):464–469

    Article  CAS  Google Scholar 

  26. LeLorier J, Duh MS, Paradis PE, et al. Economic impact of generic substitution of lamotrigine: projected costs in the US using findings in a Canadian setting. Curr Med Res Opin. 2008;24:1069–1081

    Article  Google Scholar 

  27. Nichols V, Theriault-Dube I, Touzin J, et al. Risk perception and reasons for noncompliance in pharmacovigilance: a qualitative study conducted in Canada. Drug Saf. 2009;32:579–590

    Article  Google Scholar 

  28. Health Canada. Underutilization of the adverse reaction reporting system. June 2007 (HC-POR-06-83).

  29. Green CF, Mottram DR, Raval D, et al. Community pharmacists’ attitude to adverse drug reaction reporting. Int J Pharm Pract. 1999;7:92–99

    Article  Google Scholar 

  30. Sweis D, Wong IC. A survey on factors that could affect adverse drug reaction reporting according to hospital pharmacists in Great Britain. Drug Saf. 2000;23:165–172

    Article  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Pharmacy Department, Sir Mortimer B. Davis Jewish General Hospital, 3755 Chemin de la Cote-Sainte-Catherine, Montreal, Quebec, H3T 1E2, Canada

    Benoît Rouleau BPharm, MSc

  2. Community Pharmacy, USA

    Louise Lavoie BPharm, Simon Moretti BPharm & Chantal Collin BPharm

  3. Institut Universitaire en Santé Mentale de Québec, Canada

    Jacinthe Leblanc BPharm, DPH

Authors
  1. Benoît Rouleau BPharm, MSc
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Louise Lavoie BPharm
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Jacinthe Leblanc BPharm, DPH
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Simon Moretti BPharm
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Chantal Collin BPharm
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Benoît Rouleau BPharm, MSc.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Rouleau, B., Lavoie, L., Leblanc, J. et al. Reporting of Adverse Drug Reactions by Community Pharmacists: A Qualitative Study in Quebec. Ther Innov Regul Sci 45, 627–639 (2011). https://doi.org/10.1177/009286151104500613

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1177/009286151104500613

Key Words

Search

Navigation