Skip to main content
SpringerLink
Log in

Public confidence in ADR identification and their views on ADRreporting: mixed methods study

  • Pharmacoepidemiology and Prescription
  • Published:
European Journal of Clinical Pharmacology Aims and scope Submit manuscript

Abstract

Purpose

The value of patients as potential reporters into pharmacovigilance systems is acknowledged worldwide and allowed in Thailand. However, nothing is known about the Thai public’s awareness of direct patient reporting facility or their views concerning it. This study aimed to determine confidence among members of the public in identifying suspected adverse drug reactions (ADRs), information sources they use and their views towards direct ADR reporting.

Methods

Mixed methods study consisting of self-administered questionnaires (phase 1) and semi-structured, face-to-face interviews (phase 2) with members of the public recruited in primary care centres, pharmacies and public places during October 2013 to February 2015. All questionnaire respondents reporting an ADR were invited to participate in phase 2. Written informed consent was made before the start of the interview.

Results

There were 414 (17.2%) of 2400 questionnaire respondents who had experienced an ADR, almost half (46%) of whom used their own experience to identify ADRs. Having a degree, having a severe ADR and consulting a physician increased respondent confidence in the association between medicine and suspected ADR. The majority (27) of the 30 interviewees indicated general agreement with patient reporting to regulatory authorities. Four main themes emerged covering reasons for reporting ADRs including expectations of health authorities, healthcare professionals and manufacturers, and helping other people. Awareness of direct reporting was low with a desire for a range of reporting methods.

Conclusion

Results indicate support among the Thai general public of direct ADR reporting. Greater promotion of direct reporting by all healthcare professionals is required.

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. Palleria C, Leporini C, Chimirri S et al (2013) Limitations and obstacles of the spontaneous adverse drugs reactions reporting: two “challenging” case reports. J Pharmacol Pharmacother 4:S66–S72

    Article  PubMed  PubMed Central  Google Scholar 

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

    Article  PubMed  Google Scholar 

  3. van Hunsel F, Härmark L, Pal S, Olsson S, van Grootheest K (2012) Experiences with adverse drug reaction reporting by patients: an 11-country survey. Drug Saf 35:45–60

    Article  PubMed  Google Scholar 

  4. Inch J, Watson MC, Anakwe-Umeh S (2012) Patient versus healthcare professional spontaneous adverse drug reaction reporting: a systematic review. Drug Saf 35:807–818

    Article  PubMed  Google Scholar 

  5. Avery AJ, Anderson C, Bond CM 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 15:1–234

    Article  CAS  PubMed  Google Scholar 

  6. Aagaard L, Nielsen LH, Hansen EH (2009) Consumer reporting of adverse drug reactions: a retrospective analysis of the Danish adverse drug reaction database from 2004 to 2006. Drug Saf 32:1067–1074

    Article  PubMed  Google Scholar 

  7. 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 31:515–524

    Article  PubMed  Google Scholar 

  8. Fortnum H, Lee AJ, Rupnik B, Avery A (2012) Survey to assess public awareness of patient reporting of adverse drug reactions in Great Britain. J Clin Pharm Ther 37:161–165

    Article  CAS  PubMed  Google Scholar 

  9. Krska J, Jones L, McKinney J, Wilson C (2011) Medicine safety: experiences and perceptions of the general public in Liverpool. Pharmacoepidemiol Drug Saf 20:1098–1103

    Article  PubMed  Google Scholar 

  10. Chaipichit N, Krska J, Pratipanawatr T, Uchaipichat V, Jarernsiripornkul N (2014) A qualitative study to explore how patients identify and assess symptoms as adverse drug reactions. Eur J Clin Pharmacol 70:607–615

    Article  CAS  PubMed  Google Scholar 

  11. Patsuree A, Krska J, Jarernsiripornkul N (2016) Experiences relating to adverse drug reactions in the community: a cross-sectional survey among patients and the general public in Thailand. Expert Opin Drug Saf. doi:10.1517/14740338.2016.1135127

    PubMed  Google Scholar 

  12. Jarernsiripornkul N, Patsuree A, Krska J (2015) Survey of patients’ experiences and their certainty of suspected adverse drug reactions. Int J Clin Pharm 37:168–174

    Article  Google Scholar 

  13. Phueanpinit P, Jarernsiripornkul N, Pongwecharak J, Krska J (2014) Hospital pharmacists’ roles and attitudes in providing information on the safety of non-steroidal anti-inflammatory drugs in Thailand. Int J Clin Pharm 36:1205–1212

    Article  CAS  PubMed  Google Scholar 

  14. Anderson C, Krska J, Murphy E, Avery A (2011) The importance of direct patient reporting of suspected adverse drug reactions: a patient perspective. Br J Clin Pharmacol 72:806–822

    Article  PubMed  PubMed Central  Google Scholar 

  15. Krska J, Anderson C, Murphy E, Avery AJ (2011) How patient reporters identify adverse drug reactions: a qualitative study of reporting via the UK yellow card scheme. Drug Saf 34:429–436

    Article  PubMed  Google Scholar 

  16. Yamamoto M, Kubota K, Okazaki M et al (2015) Patients views and experiences in online reporting adverse drug reactions: findings of a national pilot study in Japan. Patient Prefer Adherence 9:173–184

    Article  PubMed  PubMed Central  Google Scholar 

  17. Walji R, Boon H, Barnes J, Austin Z, Welsh S, Baker GR (2010) Consumers of natural health products: natural-born pharmacovigilantes? BMC Complement Altern Med 10:8

    Article  PubMed  PubMed Central  Google Scholar 

  18. Dewitt JE, Sorofman BA (1999) A model for understanding patient attribution of adverse drug reaction symptoms. Drug Information Journal 33:907–920

    Google Scholar 

  19. Hughes L, Whittlesea C, Luscombe D (2002) Patients’ knowledge and perceptions of the side-effects of OTC medication. J Clin Pharm Ther 27:243–248

    Article  CAS  PubMed  Google Scholar 

  20. Lorimer S, Cox A, Langford NJ (2012) A patient’s perspective: the impact of adverse drug reactions on patients and their views on reporting. J Clin Pharm Ther 37:148–152

    Article  CAS  PubMed  Google Scholar 

  21. 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 66:1143–1150

    Article  PubMed  PubMed Central  Google Scholar 

  22. van Hunsel F, ten Berge E, Borgsteede SD, van Grootheest K (2010) What motivates patients to report an adverse drug reaction? Ann Pharmacother 44:936–937

    Article  PubMed  Google Scholar 

  23. McLernon DJ, Bond CM, Lee AJ et al (2011) Patient views and experiences of making adverse drug reaction reports to the yellow card scheme in the UK. Pharmacoepidemiol Drug Saf 20:523–531

    Article  PubMed  Google Scholar 

  24. Phueanpinit P, Pongwecharak J, Krska J, Jarernsiripornkul N (2016) Medicine information leaflets for non-steroidal anti-inflammatory drugs in Thailand. Int J Clin Pharm 38:25–29

    Article  CAS  PubMed  Google Scholar 

Download references

Acknowledgments

This study received financial support from the Research Fund for Supporting Lecturer to Admit High Potential Student to Study and Research on His Expert Program Year 2012, Khon Kaen University (Number 551H101). The funding organization had no role in the design and conduct of the study; in the collection, management, analysis and interpretation of the data; or in the preparation, review or approval of the manuscript.

Special thanks are expressed to all individuals who participated in the two phases of study and to all staff who provided help in data collection at primary care units and community pharmacies.

Contributions of authors

All authors contributed to the design of the study, plan for the work and interpretation of the results. NJ and AP analysed the data and wrote the first manuscript; NJ and JK were involved in revising the manuscript. All authors approved the final submission version.

Author information

Authors and Affiliations

  1. Division of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, 40002, Thailand

    Narumol Jarernsiripornkul & Arunrot Patsuree

  2. Medway School of Pharmacy, Universities of Greenwich and Kent, Chatham Maritime, Kent, UK

    Janet Krska

Authors
  1. Narumol Jarernsiripornkul
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Arunrot Patsuree
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Janet Krska
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding authors

Correspondence to Narumol Jarernsiripornkul or Janet Krska.

Ethics declarations

The study was approved by the Khon Kaen University Ethics Committee for Human Research in accordance with the Declaration of Helsinki and the International Conference on Harmonization for Good Clinical Practice (Institutional Review Board Number: IRB00001189).

Funding

This study received financial support from the Research Fund for Supporting Lecturer to Admit High Potential Student to Study and Research on His Expert Program Year 2012, Khon Kaen University (Number 551H101).

Conflicts of interest

The authors declare that they have no conflict of interest.

Ethical approval

All procedures performed in studies involving human participants were 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.

Informed consent

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

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Jarernsiripornkul, N., Patsuree, A. & Krska, J. Public confidence in ADR identification and their views on ADRreporting: mixed methods study. Eur J Clin Pharmacol 73, 223–231 (2017). https://doi.org/10.1007/s00228-016-2155-5

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00228-016-2155-5

Keywords

Search

Navigation