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A qualitative study to explore how patients identify and assess symptoms as adverse drug reactions

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

Abstract

Purpose

To explore how Thai patients assess symptoms as adverse drug reactions (ADRs).

Methods

Out-patients at two hospitals in Thailand previously reporting suspected ADRs to statins were purposively selected to cover factors relevant to the accuracy of ADR reports. Semi-structured interviews explored the mechanisms participants used to work out whether their symptoms were related to their statin. All interviews were audio-recorded, transcribed and independently thematically analyzed by two researchers.

Results

One hundred interviews were suitable for analysis; 52 were male, age range was 36 to 77 years (mean ± S.D.: 59.83 ± 9.14) and most (92) were taking other medicines in addition to statins. Patient assessment of symptoms as ADRs fell into two major themes: medicine-related factors and external factors. Timing relationships were mentioned most frequently (74), followed by information received (55), seeing similar symptoms in others (7) and diagnosis through blood tests (4). Use of multiple medicines, consideration of the medicine versus diseases, symptoms occurring with more than one medicine or relieved through treatment reduced confidence in ADR attribution. Many participants proposed alternative explanations for symptoms, including old age. Lack of information and knowledge were obstacles to the assessment process.

Conclusions

Patients assessed possible ADRs most often by considering timing relationships. While they also used medicine information, Thai patients received inadequate information to help them assess their symptoms. Patients expressed uncertainty and difficulties in deciding attribution when concomitant medicines and diseases were involved. The findings could support the development of a patient-friendly systematic tool for identifying and assessing possible ADRs.

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Acknowledgments

This study received financial support from the Royal Golden Jubilee Ph.D. Programme and the Graduate School, Khon Kaen University. The funding organizations 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 patients who were involved in semi-structured interviews at Srinagarind hospital and Queen Sirikit Heart Center.

The authors would like to thank Dr. Ruth Rodgers and Arunrot Patsuree for their valuable cooperation in validation of translation.

Contributions of Authors

All authors participated in planning the work that led to the manuscript. NC, JK, and NJ analyzed and interpreted data, wrote the first draft, and made substantive suggestions for revision. All authors approved the final submission version.

Conflict of Interest

The authors declare that they have no conflict of interest.

Author information

Authors and Affiliations

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

    Nataporn Chaipichit, Verawan Uchaipichat & Narumol Jarernsiripornkul

  2. Medway School of Pharmacy, The Universities of Greenwich and Kent at Medway, Kent, UK

    Janet Krska

  3. Department of Internal Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand

    Thongchai Pratipanawatr

Authors
  1. Nataporn Chaipichit
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  2. Janet Krska
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  4. Verawan Uchaipichat
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  5. Narumol Jarernsiripornkul
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Correspondence to Narumol Jarernsiripornkul.

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Chaipichit, N., Krska, J., Pratipanawatr, T. et al. A qualitative study to explore how patients identify and assess symptoms as adverse drug reactions. Eur J Clin Pharmacol 70, 607–615 (2014). https://doi.org/10.1007/s00228-014-1653-6

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  • DOI: https://doi.org/10.1007/s00228-014-1653-6

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