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. 2022 Oct-Dec;20(4):2730.
doi: 10.18549/PharmPract.2022.4.2730. Epub 2022 Oct 6.

Evaluation of patient comprehension and quality of consumer medicine information

Supawinee Pongpunna  1 , Kamonphat Wongtaweepkij  2 , Thongchai Pratipanawatr  3 , Narumol Jarernsiripornkul  4
Affiliations

Evaluation of patient comprehension and quality of consumer medicine information

Supawinee Pongpunna et al. Pharm Pract (Granada). 2022 Oct-Dec.

Abstract

Background: Consumer medicine information (CMI) is voluntarily produced by pharmaceutical manufacturers in Thailand, but quality assessment of Thai-CMI is not routinely performed.

Objective: This study aimed to evaluate the content and design quality of CMI available in Thailand and assess patient understanding of the medicine information provided.

Methods: A cross-sectional study that consisted of two phases. Phase 1 was expert assessment of CMI using 15-item content checklists. Phase 2 was patient assessment of CMI by user-testing and the Consumer Information Rating Form. Participants (n=130) were outpatients aged 18 years or older with an educational level of less than grade 12. Self-administered questionnaires were distributed to patients at two university-affiliated hospitals in Thailand.

Results: A total of 60 CMI produced by 13 Thai pharmaceutical manufacturers were included in the study. Most of the CMI contained essential information about the medicines, but lacked information about serious adverse effects, maximum dose, warnings, and use in specific patient groups. Of 13 CMI selected for user-testing, none met the passing criteria with only 40.8% - 70.0% of answers found in the correct position and answered correctly. The mean values of patients' rating the CMI were between 2.5 (SD=0.8) and 3.7 (SD=0.5) for utility on a 4-point scale, and 2.3 (SD=0.7) to 4.0 (SD=0.8) for comprehensibility and 2.0 (SD=1.2) to 4.9 (SD=0.3) for design quality on a 5-point scale. Eight CMI were rated as poor (less than 3.0) for font size.

Conclusion: More safety information about medications should be included in Thai CMI and the design quality must be improved. CMI needs to be evaluated before distribution to consumers.

Keywords: assessment; consumer health communication; patient safety.

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References

    1. 1. Raynor DK, Blenkinsopp A, Knapp P, et al.A systematic review of quantitative and qualitative research on the role and effectiveness of written information available to patients about individual medicines. Health Technol Assess. 2007;11(5):1-160. https://doi.org/10.3310/hta11050 - PubMed
    2. Raynor DK, Blenkinsopp A, Knapp P, et al. A systematic review of quantitative and qualitative research on the role and effectiveness of written information available to patients about individual medicines. Health Technol Assess. 2007;11(5):1–160. doi: 10.3310/hta11050. - DOI - PubMed
    1. 2. Shrank WH, Avorn J. Educating patients about their medications:the potential and limitations of written drug information. Health Aff (Millwood). 2007;26(3):731-740. https://doi.org/10.1377/hlthaff. 26. 3.731 - PubMed
    2. Shrank WH, Avorn J. Educating patients about their medications:the potential and limitations of written drug information. Health Aff (Millwood) 2007;26(3):731–740. doi: 10.1377/hlthaff.26.3.731. - DOI - PubMed
    1. 3. Pires C, Vigário M, Cavaco A. Readability of medicinal package leaflets:a systematic review. Rev Saude Publica. 2015;49:4. https://doi.org/10.1590/s0034-8910.2015049005559 - PMC - PubMed
    2. Pires C, Vigário M, Cavaco A. Readability of medicinal package leaflets:a systematic review. Rev Saude Publica. 2015;49:4. doi: 10.1590/s0034-8910.2015049005559. - DOI - PMC - PubMed
    1. 4. Steering Committee for the Collaborative. Development of a Long-Range Action Plan for the Provision of Useful Prescription Medicine Information. 1996. Available:http://www.keystone.org/ spp/documents/ FinalActionplan.pdf. Accessed 8 September 2021.
    2. Steering Committee for the Collaborative. Development of a Long-Range Action Plan for the Provision of Useful Prescription Medicine Information. 1996. [Accessed 8 September 2021]. Available: http://www.keystone.org/ spp/documents/ FinalActionplan.pdf .
    1. 5. European Commission. Guideline on the Readability of the Labelling and Package Leaflet of Medicinal Products for Human Use. 2009. Available:https://ec.europa.eu/health/sites/ /files/files/eudralex/ vol-2/c/2009_01_12_readability_guideline_final_en.pdf. Accessed 8 September 2021.
    2. European Commission. Guideline on the Readability of the Labelling and Package Leaflet of Medicinal Products for Human Use. 2009. [Accessed 8 September 2021]. Available:https: //ec.europa.eu/health/sites/ /files/files/eudralex/ vol-2/c/2009_01_12_r... .

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