Skip to main content
SpringerLink
Log in

Healthcare professionals’ knowledge and practice of and attitudes towards pharmacovigilance in Alexandria, Egypt: a cross-sectional survey

  • Original Research Article
  • Published:
Drugs & Therapy Perspectives Aims and scope Submit manuscript

Abstract

Introduction

Pharmacovigilance as a concept is still new to healthcare professionals (HCPs) in Arabian countries. Morbidity and mortality related to adverse drug reactions (ADRs) are health problems that affect both adults and children worldwide, greatly impacting on patients’ health and the costs of healthcare services. Good pharmacovigilance programs can quickly recognize both risks and factors that reduce or prevent harm.

Objective

Our objective was to compare HCPs’ knowledge and practice of and attitudes towards pharmacovigilance in Alexandria, Egypt.

Methods

A cross-sectional survey comprising 20 questions was completed by 547 pharmacists and physicians in three different health sectors between August 2017 and March 2018. Data were analyzed using SPSS version 20. Bivariate analysis was conducted using the Chi-squared test and multivariate logistic regression. The main outcome was measuring HCPs’ knowledge and practice of and attitudes towards pharmacovigilance.

Results

In total, 232 (42.4%) physicians and 315 (57.6%) pharmacists completed the survey. The odds of having a high level of knowledge of and a positive attitude towards pharmacovigilance were nearly six times higher among pharmacists than among physicians (odds ratio [OR] 6.60 [95% confidence interval {CI} 2.31–18.85] and OR 5.66 [95% CI 2.26–14.15], respectively). The odds of high levels of pharmacovigilance practice for pharmacists were more than twice as high as those for physicians (OR 2.62 [95% CI 1.35–5.05]). Major barriers to reporting ADRs were lack of time (71%) and difficulty deciding whether or not an ADR occurred (48%).

Conclusion

In Egypt, physicians had less knowledge and less positive attitudes towards pharmacovigilance than did pharmacists. This limited knowledge among physicians could be affecting the practice of ADR reporting. Health authorities in Egypt should initiate educational interventions and a practical training program primarily targeting physicians to enhance a culture of pharmacovigilance and drug safety in the country.

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. Sultana J, Cutroneo P, Trifirò G. Clinical and economic burden of adverse drug reactions. J Pharmacol Pharmacother. 2013;4(Suppl 1):S73–7.

    Article  Google Scholar 

  2. Gyllensten H, Hakkarainen KM, Hagg S, et al. Economic impact of adverse drug events—a retrospective population-based cohort study of 4970 adults. PLoS ONE. 2014;9(3):e92061.

    Article  Google Scholar 

  3. Impicciatore P, Choonara I, Clarkson A, et al. Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies. Br J Clin Pharmacol. 2001;52(1):77–83.

    Article  CAS  Google Scholar 

  4. Gallagher R, Bird K, Mason J, et al. Adverse drug reactions causing admission to a paediatric hospital: a pilot study. J Clin Pharm Ther. 2011;36(2):194–9.

    Article  CAS  Google Scholar 

  5. Paine M. Therapeutic disasters that hastened safety testing of new drugs. Clin Pharmacol Ther. 2017;101(4):430–4.

    Article  CAS  Google Scholar 

  6. Olsson S. The role of the WHO programme on International Drug Monitoring in coordinating worldwide drug safety efforts. Drug Saf. 1998;19(1):1–10.

    Article  CAS  Google Scholar 

  7. World Health Organization. The importance of pharmacovigilance: safety monitoring of medicinal products. 2002. https://apps.who.int/iris/handle/10665/42493. Accessed 10 Nov 2020.

  8. World Health Orgnization. Safety of medicines—a guide to detecting and reporting adverse drug reactions—why health professionals need to take action. 2002. https://apps.who.int/iris/handle/10665/67378. Accessed 10 Nov 2020.

  9. Ahmad SR. Adverse drug event monitoring at the Food and Drug Administration. J Gen Intern Med. 2003;18(1):57–60.

    Article  Google Scholar 

  10. Bawazir SA. Attitude of community pharmacists in Saudi Arabia towards adverse drug reaction reporting. Saudi Pharm J. 2006;14(1):75.

    Google Scholar 

  11. Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29(5):385–96.

    Article  Google Scholar 

  12. 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(2):165–72.

    Article  CAS  Google Scholar 

  13. Green CF, Mottram DR, Rowe PH, et al. Attitudes and knowledge of hospital pharmacists to adverse drug reaction reporting. Br J Clin Pharmacol. 2001;51(1):81–6.

    Article  CAS  Google Scholar 

  14. Kelly M, Kaye KI, Davis SR, et al. Factors influencing adverse drug reaction reporting in New South Wales teaching hospitals. J Pharm Pract Res. 2004;34(1):32–5.

    Article  Google Scholar 

  15. Hasford J, Goettler M, Munter KH, et al. Physicians’ knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions. J Clin Epidemiol. 2002;55(9):945–50.

    Article  CAS  Google Scholar 

  16. Nadew SS, Beyene KG, Beza SW. Adverse drug reaction reporting practice and associated factors among medical doctors in government hospitals in Addis Ababa, Ethiopia. PLoS ONE. 2020;15(1):e0227712.

    Article  CAS  Google Scholar 

  17. Qassim S, Metwaly Z, Shamsain M, et al. Reporting adverse drug reactions: evaluation of knowledge, attitude and practice among community pharmacists in UAE. IOSR J Pharm. 2014;22(30):31–40.

    Google Scholar 

  18. Suyagh M, Farah D, Abu FR. Pharmacist’s knowledge, practice and attitudes toward pharmacovigilance and adverse drug reactions reporting process. Saudi Pharm J. 2015;23(2):147–53.

    Article  Google Scholar 

  19. Pirmohamed M. Personalized pharmacogenomics: predicting efficacy and adverse drug reactions. Annu Rev Genom Hum Genet. 2014;15:349–70.

    Article  CAS  Google Scholar 

  20. World Health Organization–Uppsala Monitoring Centre. The use of the WHO-UMC system for standardised case causality assessment. 2018.  https://www.who-umc.org/media/164200/who-umc-causality-assessment_new-logo.pdf. Accessed 18 May 2020.

  21. Uppsala Monitoring Centre. Countries participating in the WHO programme for International Drug Monitoring, with year of joining. 2018. https://www.who-umc.org/global-pharmacovigilance/who-programme-for-international-drug-monitoring/. Accessed 10 Nov 2020.

  22. Bham B. The first Eastern mediterranean region/Arab countries meeting of pharmacovigilance. Drugs Real World Outcomes. 2015;2(1):111–5.

    Article  Google Scholar 

  23. Alraie NA, Saad AA, Sabry NA, et al. Adverse drug reactions reporting: a questionnaire-based study on Egyptian pharmacists’ attitudes following an awareness workshop. J Eval Clin Pract. 2016;22(3):349–55.

    Article  Google Scholar 

  24. Alshammari TM, Alamri KK, Ghawa YA, et al. Knowledge and attitude of health-care professionals in hospitals towards pharmacovigilance in Saudi Arabia. Int J Clin Pharm. 2015;37(6):1104–10.

    Article  Google Scholar 

  25. Khan TM. Community pharmacists’ knowledge and perceptions about adverse drug reactions and barriers towards their reporting in Eastern region, Alahsa, Saudi Arabia. Ther Adv Drug Saf. 2013;4(2):45–51.

    Article  Google Scholar 

  26. Suresh K, Chandrashekara S. Sample size estimation and power analysis for clinical research studies. J Hum Reprod Sci. 2012;5(1):7–13.

    Article  Google Scholar 

  27. World Health Organization. The safety of medicines in public health programmes: pharmacovigilance an essential tool. 2006. https://www.who.int/medicines/areas/quality_safety/safety_efficacy/Pharmacovigilance_B.pdf?ua=1. Accessed 10 Nov 2020.

  28. Pérez García M, Figueras A. The lack of knowledge about the voluntary reporting system of adverse drug reactions as a major cause of underreporting: direct survey among health professionals. Pharmacoepidemiol Drug Saf. 2011;20(12):1295–302.

    Article  Google Scholar 

  29. Herdeiro MT, Figueiras A, Polónia J, et al. Influence of pharmacists’ attitudes on adverse drug reaction reporting. Drug Saf. 2006;29(4):331–40.

    Article  Google Scholar 

  30. Toklu HZ, Uysal MK. The knowledge and attitude of the Turkish community pharmacists toward pharmacovigilance in the Kadikoy district of Istanbul. Pharm World Sci. 2008;30(5):556–62.

    Article  Google Scholar 

  31. Davis DA, Thomson MA, Oxman AD, et al. Evidence for the effectiveness of CME: a review of 50 randomized controlled trials. JAMA. 1992;268(9):1111–7.

    Article  CAS  Google Scholar 

  32. Rehan H, Vasudev K, Tripathi C. Adverse drug reaction monitoring: knowledge, attitude and practices of medical students and prescribers. Natl Med J India. 2002;15(1):24–6.

    CAS  PubMed  Google Scholar 

  33. Belton K, Group EPR. Attitude survey of adverse drug-reaction reporting by health care professionals across the European Union. Eur J Pharmacol. 1997;52(6):423–7.

    CAS  Google Scholar 

  34. Taziaux P, Franck J, Ludovicy R, et al. A study of general practitioners’ prescribing behaviour to the elderly in Wallonia, Belgium. Eur J Public Health. 1996;6(1):49–57.

    Article  Google Scholar 

  35. Granas AG, Buajordet M, Stenberg-Nilsen H, et al. Pharmacists’ attitudes towards the reporting of suspected adverse drug reactions in Norway. Pharmacoepidemiol Drug Saf. 2007;16(4):429–34.

    Article  Google Scholar 

  36. Gavaza P, Brown CM, Lawson KA, et al. Influence of attitudes on pharmacists’ intention to report serious adverse drug events to the Food and Drug Administration. Br J Clin Pharmacol. 2011;72(1):143–52.

    Article  Google Scholar 

  37. Figueiras A, Herdeiro MT, Polónia J, et al. An educational intervention to improve physician reporting of adverse drug reactions: a cluster-randomized controlled trial. JAMA. 2006;296(9):1086–93.

    Article  CAS  Google Scholar 

  38. Herdeiro MT, Figueiras A, Polonia J, et al. Physicians’ attitudes and adverse drug reaction reporting: a case-control study in Portugal. Drug Saf. 2005;28(9):825–33.

    Article  Google Scholar 

  39. Belton KJ, Lewis SC, Payne S, et al. Attitudinal survey of adverse drug reaction reporting by medical practitioners in the United Kingdom. Br J Clin Pharmacol. 1995;39(3):223–6.

    Article  CAS  Google Scholar 

  40. Figueiras A, Tato F, Fontaiñas J, et al. Influence of physicians’ attitudes on reporting adverse drug events: a case-control study. Med Care. 1999;37(8):809–14.

    Article  CAS  Google Scholar 

  41. Agarwal R, Daher AM, Ismail NM. Knowledge, practices and attitudes towards adverse drug reaction reporting by private practitioners from Klang Valley in Malaysia. Malays J Med Sci. 2013;20(2):52–61.

    PubMed  PubMed Central  Google Scholar 

  42. Herdeiro MT, Polonia J, Gestal-Otero JJ, et al. Factors that influence spontaneous reporting of adverse drug reactions: a model centralized in the medical professional. J Eval Clin Pract. 2004;10(4):483–9.

    Article  Google Scholar 

Download references

Acknowledgements

The authors thank Professor Dr. Ramez Bedwany, PhD, Professor Dr. Adel Zaki, PhD (Medical Research Institute, Alexandria University), and Dr. Maged Wasfi, PhD (Faculty of Pharmacy, Alexandria University) for reviewing the manuscript and providing input.

Author information

Authors and Affiliations

  1. Department of Biomedical Informatics and Medical Statistics, Medical Research Institute, Alexandria University, Alexandria, Egypt

    Fayek Salah ELkhwsky, Iman El Sayed, Omaima Gaber Mohamed Yassine & Mai Mohamed Salama

  2. Department of Critical Care Medicine, Faculty of Medicine, Alexandria University, Alexandria, Egypt

    Sherif Abdelmonem

  3. Pharmaceutical Sciences, Faculty of Pharmacy, Alexandria University, Alexandria, Egypt

    Mai Mohamed Salama

Authors
  1. Fayek Salah ELkhwsky
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Iman El Sayed
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Omaima Gaber Mohamed Yassine
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Sherif Abdelmonem
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Mai Mohamed Salama
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Mai Mohamed Salama.

Ethics declarations

Funding

No sources of funding were used to conduct this study or prepare this manuscript.

Conflict of interest

Fayek Salah ELkhwsky, Iman El Sayed, Omaima Gaber Mohamed Yassine, Sherif Abdelmonem, and Mai Mohamed Salama have no conflicts of interest that are directly relevant to the content of this article.

Ethics approval

The study was conducted in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The questionnaire and methodology for this study was approved by the Human Research Ethics committee of the Medical Research Institute, Alexandria University (Ethics approval number: IORG#: 10RG0008812).

Consent to participate

Informed consent was obtained from all individual participants included in the study.

Consent for publication

Participants consented to submission of the manuscript to the journal.

Availability of data and material

All data and material are available upon request.

Code availability

Not applicable.

Author contributions

FSE, OGY, ISA, and MMS developed the survey instrument, drafted the manuscript and analyzed the data; MMS suggested the idea, and designed the study; SA and MMS distributed the survey questionnaire, collected the data and conducted pilot testing; FSE, OGY, and ISA contributed towards the reliability and validity of the questionnaire and proofreading the manuscript. All authors approved the version submitted for publication.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary File 1 (PDF 584 KB)

Supplementary File 1 (DOC 126 KB)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

ELkhwsky, F.S., El Sayed, I., Yassine, O.G.M. et al. Healthcare professionals’ knowledge and practice of and attitudes towards pharmacovigilance in Alexandria, Egypt: a cross-sectional survey. Drugs Ther Perspect 37, 124–136 (2021). https://doi.org/10.1007/s40267-020-00798-8

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40267-020-00798-8

Search

Navigation