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International Journal of Clinical Pharmacy

, Volume 37, Issue 1, pp 168–174 | Cite as

Survey of patients’ experiences and their certainty of suspected adverse drug reactions

  • Jarernsiripornkul NarumolEmail author
  • Patsuree Arunrot
  • Janet KrskaEmail author
Research Article

Abstract

Background Patients are best placed to recognize and monitor their own experiences of adverse drug reactions (ADRs), however they may need medicines information to help them do so. In Thailand patients rarely receive information leaflets, but are permitted to report ADRs directly to the regulator. Objectives To determine frequency of ADRs reported by hospital out-patients, the information sources used to evaluate suspected ADRs and patients’ confidence in ADR identification. Setting Srinagarind hospital in Khon Kaen, the second-largest province of North-eastern Thailand. Methods A questionnaire designed for self-completion and distributed to out-patients at this tertiary hospital using systematic random sampling over a 2-month period. Main outcome measures Frequency of reported ADRs, information sources confirming ADRs and degree of confidence in ADR identification. Results Of 1,195 questionnaires distributed, 1,044 usable responses were obtained (87.4 %). The majority of respondents were female (57.1 %) with average age 39.6 ± 13.6 years. Of 1,044 valid questionnaires, 257 (24.7 %) patients indicated they had experienced an ADR with high (56.0 %) and moderate (31.9 %) degree of confidence in ADR identification. The most frequent causative agent was an anti-infective (19.1 % of the patients). Major sources of information used for ADR assessment were healthcare professionals (35.5 %) and past ADR experience (25.5 %), with information leaflets being used infrequently (14.6 %). Conclusions This study showed high frequency of ADRs among Thai patients who were mostly confident about casual relationships with medicines. Patients mostly used healthcare professionals as confirmation source to evaluate suspected ADRs. Reliable medicines information sources such as information leaflets should be made more widely available.

Keywords

Adverse drug reactions Medicines information Patients’ experience Patient reporting Thailand 

Notes

Acknowledgments

Special thanks are expressed to all patients who completed the questionnaires and to all staff who provided help in data collection at Srinagarind Hospital.

Funding

This study received financial support from Faculty of Pharmaceutical Sciences, Khon Kaen University. 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.

Conflicts of interest

There are no conflicts of interests to declare.

References

  1. 1.
    Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet. 2000;356:1255–9.PubMedCrossRefGoogle Scholar
  2. 2.
    US General Accounting Office. FDA Drug Review: Postapproval Risks, 1976-85. Washington: US General Accounting Office; 1990.Google Scholar
  3. 3.
    Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998;279:1200–5.PubMedCrossRefGoogle Scholar
  4. 4.
    Davies EC, Green CF, Taylor S, Williamson PR, Mottram DR, Pirmohamed M. Adverse drug reactions in hospital in-patients: a prospective analysis of 3695 patient-episodes. PLoS One. 2009;4:e4439.PubMedCentralPubMedCrossRefGoogle Scholar
  5. 5.
    Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ. 2004;329:15–9.PubMedCentralPubMedCrossRefGoogle Scholar
  6. 6.
    Wu C, Bell CM, Wodchis WP. Incidence and economic burden of adverse drug reactions among elderly patients in Ontario emergency departments: a retrospective study. Drug Saf. 2012;35:769–81.PubMedCentralPubMedCrossRefGoogle Scholar
  7. 7.
    Jarernsiripornkul N, Krska J, Capps PA, Richards RM, Lee A. Patient reporting of potential adverse drug reactions: a methodological study. Br J Clin Pharmacol. 2002;53:318–25.PubMedCentralPubMedCrossRefGoogle Scholar
  8. 8.
    Hazell L, Shakir SA. Under-reporting of adverse drug reactions : a systematic review. Drug Saf. 2006;29:385–96.PubMedCrossRefGoogle Scholar
  9. 9.
    de Langen J, van Hunsel F, Passier A, de Jong-van den Berg L, van Grootheest K. Adverse drug reaction reporting by patients in the Netherlands: three years of experience. Drug Saf. 2008;31:515–24.PubMedCrossRefGoogle Scholar
  10. 10.
    van Hunsel F, Harmark L, Pal S, Olsson S, van Grootheest K. Experiences with adverse drug reaction reporting by patients: an 11-country survey. Drug Saf. 2012;35:45–60.PubMedCrossRefGoogle Scholar
  11. 11.
    Krueger JL, Hermansen-Kobulnicky CJ. Patient perspective of medication information desired and barriers to asking pharmacists questions. J Am Pharm Assoc. 2011;51:510–9.CrossRefGoogle Scholar
  12. 12.
    Elkalmi R, Hassali MA, Al-Lela OQ, Jawad Awadh AI, Al-Shami AK, Jamshed SQ. Adverse drug reactions reporting : knowledge and opinion of general public in Penang, Malaysia. J Pharm Bioallied Sci. 2013;5:224–8.PubMedCentralPubMedCrossRefGoogle Scholar
  13. 13.
    Blenkinsopp A, Wilkie P, Wang M, Routledge PA. Patient reporting of suspected adverse drug reactions: a review of published literature and international experience. Br J Clin Pharmacol. 2007;63:148–56.PubMedCentralPubMedCrossRefGoogle Scholar
  14. 14.
    Avery AJ, Anderson C, Bond CM, Fortnum H, Gifford A, Hannaford PC, et al. 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. 2011;15:1–234.PubMedCrossRefGoogle Scholar
  15. 15.
    Rolfes L, van Hunsel F, Wilkes S, Grootheest KV, Puijenbroek EV. Adverse drug reaction reports of patients and healthcare professionals-differences in reported information. Pharmacoepidemiol Drug Saf. 2014. [Epub ahead of print].Google Scholar
  16. 16.
    Jarernsiripornkul N, Senacom P, Uchaipicha V, Chaipichit N, Krska J. Patient reporting of suspected ADRs to anti-epileptic drugs in Thailand: factors affecting attribution accuracy. Epilepsy Behav. 2012;24:102–6.PubMedCrossRefGoogle Scholar
  17. 17.
    Herxheimer A, Crombag R, Alves TL. Adverse drug reactions: a fifteen-country survey and literature review [Internet]. Health Action International Europe. 2010. http://consumers.cochrane.org/sites/consumers.cochrane.org/files/uploads/10%20May%202010%20Report%20Direct%20Patient%20Reporting%20of%20ADRs.pdf.
  18. 18.
    Inch J, Watson MC, Anakwe-Umeh S. Patient versus healthcare professional spontaneous adverse drug reaction reporting: a systematic review. Drug Saf. 2012;35:807–18.PubMedCrossRefGoogle Scholar
  19. 19.
    Jarernsiripornkul N, Chaisrisawadsuk S, Chaiyakum A, Krska J. Patient self-reporting of potential adverse drug reactions to non-steroidal anti-inflammatory drugs in Thailand. Pharm World Sci. 2009;31:559–64.PubMedCrossRefGoogle Scholar
  20. 20.
    Anderson C, Krska J, Murphy E, Avery A. The importance of direct patient reporting of suspected adverse drug reactions: a patient perspective. Br J Clin Pharmacol. 2011;72:806–22.PubMedCentralPubMedCrossRefGoogle Scholar
  21. 21.
    van Hunsel F, van der Welle C, Passier A, van Puijenbroek E, van Grootheest K. Motives for reporting adverse drug reactions by patient-reporters in the Netherlands. Eur J Clin Pharmacol. 2010;66:1143–50.PubMedCentralPubMedCrossRefGoogle Scholar
  22. 22.
    Valente S, Murray LP. Creative strategies to improve patient safety: allergies and adverse drug reactions. J Nurses Staff Dev. 2011;27:E1–5.PubMedCrossRefGoogle Scholar
  23. 23.
    Krska J, Morecroft CW. Patients’ use of information about medicine side effects in relation to experiences of suspected adverse drug reactions: a cross-sectional survey in medical in-patients. Drug Saf. 2013;36(8):673–80.PubMedCrossRefGoogle Scholar
  24. 24.
    Krska J, Jones L, McKinney J, Wilson C. Medicines safety: experiences and perceptions of the general public in Liverpool. Pharmacoepidemiol Drug Saf. 2011;20(10):1098–103.PubMedCrossRefGoogle Scholar
  25. 25.
    Miller GC, Britth HC, Valenti L. Adverse drug events in general practice patients in Australia. Med J Aust. 2006;184:321–4.PubMedGoogle Scholar
  26. 26.
    McLernon DJ, Bond CM, Lee AJ, Watson MC, Hannaford PC, Fortnum H, et al. Patient views and experiences of making adverse drug reaction reports to the Yellow Card Scheme in the UK. Pharmacoepidemiol Drug Saf. 2011;20:523–31.PubMedCrossRefGoogle Scholar
  27. 27.
    Center Health Product Vigilance. ADR reporting 2012. Bangkok: Thai Food and Drug Administration, Ministry of Public Health; 2012.Google Scholar
  28. 28.
    Krska J, Anderson C, Murphy E, Avery AJ. How patient reporters identify adverse drug reactions: a qualitative study of reporting via the UK Yellow Card Scheme. Drug Saf. 2011;34:429–36.PubMedCrossRefGoogle Scholar
  29. 29.
    Hughes L, Whittlesea C, Luscombe D. Patients’ knowledge and perceptions of the side-effects of OTC medication. J Clin Pharm Ther. 2002;27:243–8.PubMedCrossRefGoogle Scholar
  30. 30.
    Phueanpinit P, Jarernsiripornkul N, Pongwecharak J, Krska J. Hospital pharmacists’ roles and attitudes in providing information on the safety of non-steroidal anti-inflammatory drugs in Thailand. Int J Clin Pharm. 2014;36:1205–12.Google Scholar

Copyright information

© Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie 2015

Authors and Affiliations

  1. 1.Department of Clinical Pharmacy, Faculty of Pharmaceutical SciencesKhon Kaen UniversityKhon KaenThailand
  2. 2.Medway School of PharmacyUniversities of Greenwich and KentChatham MaritimeUK

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