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Use of Warfarin in Oral Anticoagulation Therapy: Challenges and EmpoderACO Strategy for Promoting Patient Empowerment in Self-Care

Empowerment for Health; Health Behavior; Health Education; Anticoagulants; Warfarin

Warfarin is an oral anticoagulant widely used for primary and secondary prevention of thromboembolism that belongs to the class of vitamin K antagonists.11. Fahmi AM, Elewa H, Jilany I. Warfarin dosing strategies evolution and its progress in the era of precision medicine, a narrative review. Int J Clin Pharm. 2022;44(3):599-607. doi: 10.1007/s11096-022-01386-8
https://doi.org/10.1007/s11096-022-01386...
,22. ISMP Brasil. Instituto para Práticas Seguras no Uso de Medicamentos. Prevenção de erros de medicação entre pacientes em uso de anticoagulantes orais. [Internet]. Boletim ISMP Brasil.2020;9(3):1-11. [acesso 20 maio de 2023]. Disponível em: https://www.ismp-brasil.org/site/wp-content/uploads/2020/06/BOLETIM_ISMP_MAIO_ANTICOAGULANTES_ORAIS.pdf
https://www.ismp-brasil.org/site/wp-cont...
In Brazil, warfarin is still the main oral anticoagulant distributed free of charge by the Unified Health System.33. Brasil. Ministério da Saúde, Secretaria de Ciência, Tecnologia, Inovação e Insumos Estratégicos em Saúde, Departamento de Assistência Farmacêutica e Insumos Estratégicos. Relação Nacional de Medicamentos Essenciais Rename 2022. Brasília; 2022. p. 183. According to the Institute for Safe Practices in the Use of Medicines (ISMP - Brazil), warfarin is classified as a high-alert or potentially dangerous drug since it has a low therapeutic index and its use requires constant attention for the drug to act in the prevention of thromboembolic events without increasing the risk of hemorrhages.22. ISMP Brasil. Instituto para Práticas Seguras no Uso de Medicamentos. Prevenção de erros de medicação entre pacientes em uso de anticoagulantes orais. [Internet]. Boletim ISMP Brasil.2020;9(3):1-11. [acesso 20 maio de 2023]. Disponível em: https://www.ismp-brasil.org/site/wp-content/uploads/2020/06/BOLETIM_ISMP_MAIO_ANTICOAGULANTES_ORAIS.pdf
https://www.ismp-brasil.org/site/wp-cont...
,44. Wigle P, Hein B, Bernheisel CR. Anticoagulation: updated guidelines for outpatient management. Am Fam Physician. 2019; 100(7):426-34. PMID: 31573167. Furthermore, it appears as one of the drugs that should be the target of priority actions for the prevention of damage, according to the Third Global Patient Safety Challenge of the World Health Organization Health.22. ISMP Brasil. Instituto para Práticas Seguras no Uso de Medicamentos. Prevenção de erros de medicação entre pacientes em uso de anticoagulantes orais. [Internet]. Boletim ISMP Brasil.2020;9(3):1-11. [acesso 20 maio de 2023]. Disponível em: https://www.ismp-brasil.org/site/wp-content/uploads/2020/06/BOLETIM_ISMP_MAIO_ANTICOAGULANTES_ORAIS.pdf
https://www.ismp-brasil.org/site/wp-cont...

Management of anticoagulant therapy with warfarin is a challenge for many patients. It requires procedures that are considered complex, such as the regular measurement of the international normalized ratio (INR), the interpretation of the results to adjust the drug dose by the responsible team, as well as the adequate understanding of the factors that may influence its effectiveness and safety, such as adverse reactions and interactions with other drugs and foods.22. ISMP Brasil. Instituto para Práticas Seguras no Uso de Medicamentos. Prevenção de erros de medicação entre pacientes em uso de anticoagulantes orais. [Internet]. Boletim ISMP Brasil.2020;9(3):1-11. [acesso 20 maio de 2023]. Disponível em: https://www.ismp-brasil.org/site/wp-content/uploads/2020/06/BOLETIM_ISMP_MAIO_ANTICOAGULANTES_ORAIS.pdf
https://www.ismp-brasil.org/site/wp-cont...
,44. Wigle P, Hein B, Bernheisel CR. Anticoagulation: updated guidelines for outpatient management. Am Fam Physician. 2019; 100(7):426-34. PMID: 31573167. Thus, strategies are needed to help in the proper and safe use of the medication and contribute to understanding its use process and consequent adherence to treatment.

The study by Barbosa et al.55. Barbosa HC, Torres HC, Oliveira JAQ, Santos RPM, Costa JM,1 Miranda LG, et al. Construction and Validation of a Protocol Targeting Patients on Oral Anticoagulation with Warfarin. DOI: https://doi.org/10.36660/abc.20220576. Arq Bras Cardiol. 2023; 120(6):e20220576
https://doi.org/10.36660/abc.20220576...
aimed to build and validate the EmpoderACO protocol to change patients’ behavior on oral anticoagulation with warfarin. The items in the tool were organized based on the five steps in the Behavior Change Protocol.66. Funnell MM, Tang TS, Anderson RM. From DSME to DSMS: developing Empowerment- Based Diabetes self-management support. Diabetes Spectr. 2007;20(4):221-6. doi:https://doi.org/102337/diaspect.20.221
https://doi.org/102337/diaspect.20.221...
,77. Chaves FA, Cecilio SG, Reis IA, Pagano AS, Torres HC. Translation and cross-cultural adaptation of the Behavior Change Protocol for educational practices in Diabetes Mellitus. Rev Lat Am Enfermagem. 2019;27:e3164. doi: 10.1590/1518-8345.2908.3164
https://doi.org/10.1590/1518-8345.2908.3...
The construction and validation of the EmpoderACO protocol followed well-defined steps proposed by the studies by Coluci88. Coluci MZ, Alexandre NM, Milani D. Construção de instrumentos de medida na área da saúde. Cienc Saude Coletiva.2015;20(3):925-36. doi: 10.1590/1413-81232015203.04332013.
https://doi.org/10.1590/1413-81232015203...
and Pasquali.99. Pasquali L. Princípios de elaboração de escalas psicológicas. Rev Psiquiatr Clin. 1998; 25(5):206-13. Initially, a conceptual map was built to identify self-care domains in oral anticoagulation. The development of the instrument included the participation of an internal and external expert committee composed of different health professionals. After this stage, the protocol was submitted for content validity assessment by the Committee of Judges, followed by the performance of the pre-test in patients using warfarin.

The final version of the instrument resulted in 27 items comprising different domains of self-care in oral anticoagulation. The EmpoderACO protocol can be applied in clinical practice as support in patient care, used by health professionals to strengthen the quality of interventions and encourage user empowerment regarding their pharmacotherapy. The patient’s involvement in their care process is one of the central components of person-centered care, which is related to the professional’s partnership with the user based on interaction and knowledge of the needs and problems experienced by the latter. Person-centered care emphasizes the idea that the professional should not only investigate diseases but also meet the needs of the individual more broadly, considering its subjectivity.1010. Starfield B. Is patient-centered care the same as person-focused care? The Perm J. 15(2):63-9. doi: 10.7812/TPP/10-148.
https://doi.org/10.7812/TPP/10-148...

The care developed in the management of oral anticoagulation with warfarin, especially in the context of primary health care, requires a long follow-up time in the health service, as well as building a relationship of trust with the professional so that the therapeutic bond helps in achieving the goals with the treatment and in the process of self-knowledge of the user about their treatment.1111. Universidade Federal do Rio Grande do Sul. Programa de Pós-Graduação em Epidemiologia. TelessaúdeRS (TelessaúdeRS-UFRGS). Como iniciar anticoagulação com varfarina na Atenção Primária à Saúde? Porto Alegre: TelessaúdeRS-UFRGS; 28 Mar 2022[acesso em mai 2023”]. Disponível em: https://www.ufrgs.br/telessauders/perguntas/ps-anticoagulacao-varfarina/
https://www.ufrgs.br/telessauders/pergun...
,1212. Magon A, Arrigoni C, Durante A, Falchi C, Dellafiore F, Stievano A, et al. Barriers to self‐monitoring implementation in the oral anticoagulated population: A qualitative study. Int J Nurs Pract. 2023;29(1):e13095. doi: 10.1111/ijn.13095.
https://doi.org/10.1111/ijn.13095...
This engagement also requires the consideration of the health literacy of individuals, that is, their knowledge, motivation, and skills to act, understand, evaluate, and apply health information to decisions related to care.1313. Sorensen K, Van den Broucke S, Fullam J, Doyle G, Pelikan J, Slonska Z, et al. Health literacy and public health: a systematic review and integration of definitions and models. BMC Public Health. 2012;12:80. doi: 10.1186/1471-2458-12-80
https://doi.org/10.1186/1471-2458-12-80...

Studies carried out in Brazil and Australia found a positive association between low levels of health literacy and worse outcomes related to managing oral anticoagulation therapy with warfarin.1414. Martins MA, Costa JM, Mambrini JV, Ribeiro AL, Benjamin EJ, Brant LC, et al. Health literacy and warfarin therapy at two anticoagulation clinics in Brazil. Heart. 2017;103(14):1089-95. doi: 10.1136/heartjnl-2016-310699
https://doi.org/10.1136/heartjnl-2016-31...
,1515. Yiu AW, Bajorek BV. Health literacy and knowledge in a cohort of Australian patients taking warfarin. Pharm Pract (Granada). 2018;16(1):1080. doi: 10.18549/PharmPract.2018.01.1080
https://doi.org/10.18549/PharmPract.2018...
In addition, the systematic review by Kim et al.1616. Kim JM, Suarez-Cuervo C, Berger Z, Lee J, Gayleard J, Rosenberg C, et al. Evaluation of patient and family engagement strategies to improve medication safety. Patient. 2018;11(2):193-206. doi: 10.1007/s40271-017-0270-8
https://doi.org/10.1007/s40271-017-0270-...
in 2017, which evaluated different patient and family engagement strategies to improve medication safety, points out that interventions for the patient engagement should not only have an informative function but should incorporate higher levels of patient engagement. These include actions involving the patient in decision-making and active communication with the health team, as well as establishing partnerships with individuals in care to become collaborators in their care process and including patients as integral members of the care team.

EmpoderACO contemplates aspects of high levels of engagement and can be an auxiliary tool for patient empowerment and involvement in their self-care process. In addition, future studies can evaluate the tool’s implementation in individuals with different characteristics in different scenarios and evaluate its strengths and weaknesses to promote the safe use of this anticoagulant.

Referências

  • 1
    Fahmi AM, Elewa H, Jilany I. Warfarin dosing strategies evolution and its progress in the era of precision medicine, a narrative review. Int J Clin Pharm. 2022;44(3):599-607. doi: 10.1007/s11096-022-01386-8
    » https://doi.org/10.1007/s11096-022-01386-8
  • 2
    ISMP Brasil. Instituto para Práticas Seguras no Uso de Medicamentos. Prevenção de erros de medicação entre pacientes em uso de anticoagulantes orais. [Internet]. Boletim ISMP Brasil.2020;9(3):1-11. [acesso 20 maio de 2023]. Disponível em: https://www.ismp-brasil.org/site/wp-content/uploads/2020/06/BOLETIM_ISMP_MAIO_ANTICOAGULANTES_ORAIS.pdf
    » https://www.ismp-brasil.org/site/wp-content/uploads/2020/06/BOLETIM_ISMP_MAIO_ANTICOAGULANTES_ORAIS.pdf
  • 3
    Brasil. Ministério da Saúde, Secretaria de Ciência, Tecnologia, Inovação e Insumos Estratégicos em Saúde, Departamento de Assistência Farmacêutica e Insumos Estratégicos. Relação Nacional de Medicamentos Essenciais Rename 2022. Brasília; 2022. p. 183.
  • 4
    Wigle P, Hein B, Bernheisel CR. Anticoagulation: updated guidelines for outpatient management. Am Fam Physician. 2019; 100(7):426-34. PMID: 31573167.
  • 5
    Barbosa HC, Torres HC, Oliveira JAQ, Santos RPM, Costa JM,1 Miranda LG, et al. Construction and Validation of a Protocol Targeting Patients on Oral Anticoagulation with Warfarin. DOI: https://doi.org/10.36660/abc.20220576 Arq Bras Cardiol. 2023; 120(6):e20220576
    » https://doi.org/10.36660/abc.20220576
  • 6
    Funnell MM, Tang TS, Anderson RM. From DSME to DSMS: developing Empowerment- Based Diabetes self-management support. Diabetes Spectr. 2007;20(4):221-6. doi:https://doi.org/102337/diaspect.20.221
    » https://doi.org/102337/diaspect.20.221
  • 7
    Chaves FA, Cecilio SG, Reis IA, Pagano AS, Torres HC. Translation and cross-cultural adaptation of the Behavior Change Protocol for educational practices in Diabetes Mellitus. Rev Lat Am Enfermagem. 2019;27:e3164. doi: 10.1590/1518-8345.2908.3164
    » https://doi.org/10.1590/1518-8345.2908.3164
  • 8
    Coluci MZ, Alexandre NM, Milani D. Construção de instrumentos de medida na área da saúde. Cienc Saude Coletiva.2015;20(3):925-36. doi: 10.1590/1413-81232015203.04332013.
    » https://doi.org/10.1590/1413-81232015203.04332013
  • 9
    Pasquali L. Princípios de elaboração de escalas psicológicas. Rev Psiquiatr Clin. 1998; 25(5):206-13.
  • 10
    Starfield B. Is patient-centered care the same as person-focused care? The Perm J. 15(2):63-9. doi: 10.7812/TPP/10-148.
    » https://doi.org/10.7812/TPP/10-148
  • 11
    Universidade Federal do Rio Grande do Sul. Programa de Pós-Graduação em Epidemiologia. TelessaúdeRS (TelessaúdeRS-UFRGS). Como iniciar anticoagulação com varfarina na Atenção Primária à Saúde? Porto Alegre: TelessaúdeRS-UFRGS; 28 Mar 2022[acesso em mai 2023”]. Disponível em: https://www.ufrgs.br/telessauders/perguntas/ps-anticoagulacao-varfarina/
    » https://www.ufrgs.br/telessauders/perguntas/ps-anticoagulacao-varfarina/
  • 12
    Magon A, Arrigoni C, Durante A, Falchi C, Dellafiore F, Stievano A, et al. Barriers to self‐monitoring implementation in the oral anticoagulated population: A qualitative study. Int J Nurs Pract. 2023;29(1):e13095. doi: 10.1111/ijn.13095.
    » https://doi.org/10.1111/ijn.13095
  • 13
    Sorensen K, Van den Broucke S, Fullam J, Doyle G, Pelikan J, Slonska Z, et al. Health literacy and public health: a systematic review and integration of definitions and models. BMC Public Health. 2012;12:80. doi: 10.1186/1471-2458-12-80
    » https://doi.org/10.1186/1471-2458-12-80
  • 14
    Martins MA, Costa JM, Mambrini JV, Ribeiro AL, Benjamin EJ, Brant LC, et al. Health literacy and warfarin therapy at two anticoagulation clinics in Brazil. Heart. 2017;103(14):1089-95. doi: 10.1136/heartjnl-2016-310699
    » https://doi.org/10.1136/heartjnl-2016-310699
  • 15
    Yiu AW, Bajorek BV. Health literacy and knowledge in a cohort of Australian patients taking warfarin. Pharm Pract (Granada). 2018;16(1):1080. doi: 10.18549/PharmPract.2018.01.1080
    » https://doi.org/10.18549/PharmPract.2018.01.1080
  • 16
    Kim JM, Suarez-Cuervo C, Berger Z, Lee J, Gayleard J, Rosenberg C, et al. Evaluation of patient and family engagement strategies to improve medication safety. Patient. 2018;11(2):193-206. doi: 10.1007/s40271-017-0270-8
    » https://doi.org/10.1007/s40271-017-0270-8
  • Short Editorial related to the article: Construction and Validation of a Protocol Targeting Patients on Oral Anticoagulation with Warfarin

Publication Dates

  • Publication in this collection
    30 June 2023
  • Date of issue
    June 2023
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