Educação em equivalência terapêutica: impacto sobre tomada de decisão do paciente, compreensão do tratamento e segurança do uso de medicamentos

Authors

  • Giselle Ávila Sousa Farmacêutica e Bioquímica, Conselho Regional de Farmácia do Estado de Goiás (CRF-GO), Brasil. Autor Author

DOI:

https://doi.org/10.69849/7e26nb79

Keywords:

therapeutic equivalence, patient education, community pharmacy, pharmacist counseling, medication adherence, patient safety

Abstract

Therapeutic equivalence, while grounded in regulatory standards, has practical implications for safety and continuity of treatment when interpreted by patients in community pharmacy settings. At the counter, conceptual confusion between reference, generic, and similar medicines may increase decisional insecurity, unadvised switching across presentations, and the likelihood of medication misuse, with downstream effects on adherence and preventable harm. A pharmacist-led education model is proposed as a clinical communication intervention designed for high-demand workflows, integrating: essential counseling content, standardized language, comprehension verification (teach-back), and minimal documentation for governance. The approach is framed as a patient-safety strategy linking medication literacy and informed decision-making, organized to sustain fidelity under workforce and workflow variability. In the absence of consolidated longitudinal quantitative data, a pragmatic evaluation architecture is defined, relying on process, comprehension, and safety indicators suitable for prospective sampling. This set of elements outlines a replicable strategy to reduce confusion, strengthen treatment understanding, and mitigate risks associated with substitution and home medication use.

References

AGENCY FOR HEALTHCARE RESEARCH AND QUALITY. Health literacy universal precautions toolkit. 2. ed. Rockville, MD: Agency for Healthcare Research and Quality, 2015. (AHRQ Publication No. 15-0023-EF). Disponível em: https://labpages2.moffitt.org/media/1499/ahrq-hl-toolkit-2nd-edition-2015.pdf.

BERKMAN, N. D.; SHERIDAN, S. L.; DONAHUE, K. E.; HALPERN, D. J.; CROTTY, K. Low health literacy and health outcomes: an updated systematic review. Annals of Internal Medicine, v. 155, n. 2, p. 97-107, 2011. DOI: 10.7326/0003-4819-155-2-201107190-00005.

CHARLES, C.; GAFNI, A.; WHELAN, T. Shared decision-making in the medical encounter: what does it mean? (or it takes at least two to tango). Social Science & Medicine, v. 44, n. 5, p. 681-692, 1997.

COCHRANE CONSUMERS AND COMMUNICATION GROUP. Improving communication in healthcare: evidence and implications. [Referência não confirmada com estes dados — ver lista ao final].

DAVIS, T. C.; WOLF, M. S.; BASS, P. F.; THOMPSON, J. A.; TILSON, H. H.; NEUBERGER, M.; PARKER, R. M. Literacy and misunderstanding prescription drug labels. Annals of Internal Medicine, v. 145, n. 12, p. 887-894, 2006.

ELWYN, G.; FROSCH, D.; THOMSON, R.; JOSEPH-WILLIAMS, N.; LLOYD, A.; KINNERSLEY, P.; CORDING, E.; TOMSON, D.; DODD, C.; ROLLNICK, S.; EDWARDS, A.; BARRY, M. Shared decision making: a model for clinical practice. Journal of General Internal Medicine, v. 27, n. 10, p. 1361-1367, 2012.

EUROPEAN MEDICINES AGENCY. Guideline on the investigation of bioequivalence (Rev. 1). London: EMA, 2010. Disponível em: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-bioequivalence-rev1_en.pdf.

FOOD AND DRUG ADMINISTRATION (UNITED STATES). Approved drug products with therapeutic equivalence evaluations (Orange Book). Silver Spring, MD: U.S. FDA, 2026. Disponível em: https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book.

FRANSEN, M. P.; VAN SCHAIK, T. M.; TWICKLER, T. B.; ESSINK-BOT, M. L. Applicability of internationally available health literacy measures in the Netherlands. Journal of Health Communication, v. 16, supl. 3, p. 134-149, 2011.

GRISSINGER, M. The five rights: a destination without a map. P T, v. 35, n. 10, p. 542, 2010. Disponível em: https://pmc.ncbi.nlm.nih.gov/articles/PMC2957754/.

HERSH, L.; SALZMAN, B.; SNYDERMAN, D. Health literacy in primary care practice. American Family Physician, v. 92, n. 2, p. 118-124, 2015.

HOLT, E. W.; RUNG, A. L.; LEON, K. A.; FIRESTEIN, C.; KROUSEL-WOOD, M. A. Medication adherence in older adults: a qualitative study. Educational Gerontology, v. 41, n. 3, p. 198-211, 2015.

INSTITUTE OF MEDICINE. Health literacy: a prescription to end confusion. Washington, DC: National Academies Press, 2004.

KRIPALANI, S.; YAO, X.; HAYNES, R. B. Interventions to enhance medication adherence in chronic medical conditions. Archives of Internal Medicine, v. 167, n. 6, p. 540-550, 2007.

LINDQUIST, L. A.; GO, L.; FLEISHER, J.; JAIN, N.; FRIESEMA, E.; BAKER, D. W. Relationship of health literacy to intentional and unintentional non-adherence of hospital discharge medications. Journal of General Internal Medicine, v. 26, n. 6, p. 619-626, 2011.

MCCAFFERY, K. J.; HOLMES-ROVNER, M.; SMITH, S. K. Addressing health literacy in patient decision aids. BMC Medical Informatics and Decision Making, v. 13, supl. 2, S10, 2013.

MORRISON, A. K.; SCHAPIRA, M. M.; GORELICK, M. H.; HOFFMANN, R. G.; BROUSSEAU, D. C. Low caregiver health literacy is associated with higher pediatric emergency department use and nonurgent visits. Academic Pediatrics, v. 14, n. 3, p. 309-314, 2014.

OSTERBERG, L.; BLASCHKE, T. Adherence to medication. The New England Journal of Medicine, v. 353, n. 5, p. 487-497, 2005.

SCHILLINGER, D.; PIETTE, J.; GRUMBACH, K.; WANG, F.; WILSON, C.; DAHER, C.; LEONG GROTZ, K.; CASTRO, C.; BINDMAN, A. B. Closing the loop: physician communication with diabetic patients who have low health literacy. Archives of Internal Medicine, v. 163, n. 1, p. 83-90, 2003.

SHRANK, W. H.; COX, E. R.; FISCHER, M. A.; MEHTA, J.; CHOUDHRY, N. K. Patients’ perceptions of generic medications. Health Affairs, v. 28, n. 2, p. 546-556, 2009.

SØRENSEN, K.; VAN DEN BROUCKE, S.; FULLAM, J.; DOYLE, G.; PELIKAN, J.; SLONSKA, Z.; BRAND, H. Health literacy and public health: a systematic review and integration of definitions and models. BMC Public Health, v. 12, art. 80, 2012.

WORLD HEALTH ORGANIZATION. Medication without harm: global patient safety challenge on medication safety. Geneva: WHO, 2017.

WORLD HEALTH ORGANIZATION; INTERNATIONAL PHARMACEUTICAL FEDERATION. Developing pharmacy practice: a focus on patient care. Geneva: WHO; The Hague: FIP, 2006.

ZOLNIEREK, K. B. H.; DIMATTEO, M. R. Physician communication and patient adherence to treatment: a meta-analysis. Medical Care, v. 47, n. 8, p. 826-834, 2009.

Published

2026-03-10

How to Cite

Sousa, G. Ávila. (2026). Educação em equivalência terapêutica: impacto sobre tomada de decisão do paciente, compreensão do tratamento e segurança do uso de medicamentos. Revista Ft, 30(156), 01-12. https://doi.org/10.69849/7e26nb79