Effect of an intervention New Medicine Service to improve adherence in the Spanish community pharmacies: a protocol of a pragmatic randomised trial

María de los Angeles González Vera; María del Carmen Valcárcel Cabrera; Javier López Narbona; María del Carmen Sánchez-Cantalejo Garrido; Juan Pedro  Vaquero Prada; Antonio Olry de Labry Lima

doi:10.30827/ars.v63i3.24625

Authors

María de los Angeles González Vera Community pharmacies. Pinos Puente, Granada. Programa de Doctorado en Farmacia Social de la Universidad de Granada
María del Carmen Valcárcel Cabrera Escuela Andaluza de Salud Pública (Andalusian School of Public Health). Granada
Javier López Narbona Servicio de Innovación en Consejería de Salud y Familias. (Innovation Service of the Regional Ministry for Health and Family Affairs of Andalusia). Seville
María del Carmen Sánchez-Cantalejo Garrido Programa de Doctorado en Farmacia Social de la Universidad de Granada
Juan Pedro Vaquero Prada Community pharmacies, Seville
Antonio Olry de Labry Lima Centro Andaluz de Información de Medicamentos (Cadime). Escuela Andaluza de Salud Pública. Granada, Spain. 7CIBER en Epidemiología y Salud Pública (CIBERESP) 8ibs.GRANADA, Instituto de Investigación Biosanitario (Institute of Biomedical Research (ibs) Granada, Spain. University Hospitals of Granada/ University of Granada, Spain https://orcid.org/0000-0001-5448-1370

DOI:

https://doi.org/10.30827/ars.v63i3.24625

Keywords:

Community Pharmacy Services; adherence; intervention; protocol

Abstract

Introduction: Non-adherence to medications is one of the challenges health systems faces. Patients with poor adherence to treatment fail to benefit from effective medication, and this is associated with reductions in quality of life, poorer outcomes, increased hospitalisations, deaths, and, consequently, higher healthcare costs. Community pharmacies are shown to be key elements in improving adherence to prescribed medications, optimising patient outcomes and increasing the efficiency of care.

Objectives: (1) assess the effectiveness of the New Medicine Service (NMS) intervention delivered by community pharmacists to improve adherence to treatment in patients who have been prescribed a new medicine for a specific chronic condition; and (2) to conduct an economic evaluation of this intervention.

Methods: A pragmatic randomized clinical trial at community pharmacy-level (clusters) will be performed. Patients identified in the collaborating community pharmacy as starting treatment for the following conditions, will be invited to join the study: chronic obstructive pulmonary disease, hypertension, diabetes mellitus or on an anticoagulant/antiplatelet agent. The intervention is based on the pharmacist-patient communication, aiming to assess the patient’s relationship with his/her new prescription, and identify potential issues, concerns and false beliefs or expectations.

Ethics and dissemination: The study protocol has been reviewed and ethics approval obtained from the regional ethics committee. The results from this study will be actively disseminated through manuscript publications and conference presentations.

Downloads

Download data is not yet available.

References

Akhter K, Sutton S, Mirzaei V, Kassavou A. A Systematic Review and Meta-analysis of Face-to-face Medication Adherence Interventions for Patients with Long Term Health Conditions. Ann Behav Med. 2022:kaac010. doi: 10.1093/abm/kaac010.

Sabate E. Adherence to long-term therapies: evidence for action. Geneva, Switzerland: World Health Organization, 2003.

Hope HF, Binkley GM, Fenton S, Kitas GD, Verstappen SMM, Symmons DPM. Systematic review of the predictors of statin adherence for the primary prevention of cardiovascular disease. PLoS One. 2019;14(1):e0201196. doi: 10.1371/journal.pone.0201196.

Monteiro C, Maricoto T, Prazeres F, Augusto Simões P, Augusto Simões J. Determining factors associated with inhaled therapy adherence on asthma and COPD: A systematic review and meta-analysis of the global literature. Respir Med. 2022;191:106724. doi: 10.1016/j.rmed.2021.106724.

Ababneh M, Nasser SA, Rababa’h A, Ababneh F. Warfarin adherence and anticoagulation control in atrial fibrillation patients: a systematic review. Eur Rev Med Pharmacol Sci. 2021;25(24):7926-7933. doi: 10.26355/eurrev_202112_27642.

Nieuwlaat R, Wilczynski N, Navarro T, Hobson N, Jeffery R, Keepanasseril A, et al. Interventions for enhancing medication adherence. Cochrane Database Syst Rev. 2014;2014(11):CD000011. doi: 10.1002/14651858.CD000011.pub4.

Lopez-Valcarcel BG, Barber P. Economic Crisis, Austerity Policies, Health and Fairness: Lessons Learned in Spain. Appl Health Econ Health Policy. 2017;15(1):13-21. doi: 10.1007/s40258-016-0263-0.

Oñatibia-Astibia A, Aizpurua-Arruti X, Malet-Larrea A, Gastelurrutia MA, Goyenechea E. El papel del farmacéutico comunitario en la detección y disminución de los errores de medicación: revisión sistemática exploratoria. Ars Pharm. 2021;62:16-39. doi: 10.30827/ars.v62i1.15901

Gastelurrutia MA, Llimós FF, Delgado PG, Gastelurrutia P, Faus MJ, Benrimoj SI. Barriers and facilitators to the dissemination and implementation of cognitive services in Spanish community pharmacies. Pharm Pract (Granada). 2005;3(2):65-77.

Patwardhan PD, Amin ME, Chewning BA. Intervention research to enhance community pharmacists’ cognitive services: a systematic review. Res Social Adm Pharm. 2014;10(3):475-93. doi: 10.1016/j.sapharm.2013.07.005.

Gastelurrutia MA, Fernández-Llimos F, Benrimoj SI, Castrillon CC, Faus MJ. Barreras para la implantación de servicios cognitivos en la farmacia comunitaria española. Aten Primaria. 2007;39(9):465-70. doi: 10.1157/13109494.

Elliott RA, Boyd MJ, Tanajewski L, Barber N, Gkountouras G, Avery AJ, et al. ‘New Medicine Service’: supporting adherence in people starting a new medication for a long-term condition: 26-week follow-up of a pragmatic randomised controlled trial. BMJ Qual Saf. 2020;29(4):286-295. doi: 10.1136/bmjqs-2018-009177.

Boyd M, Waring J, Barber N, Mehta R, Chuter A, Avery AJ, et al. Protocol for the New Medicine Service Study: a randomized controlled trial and economic evaluation with qualitative appraisal comparing the effectiveness and cost effectiveness of the New Medicine Service in community pharmacies in England. Trials. 2013;14:411. doi: 10.1186/1745-6215-14-411.

Hovland R, Bremer S, Frigaard C, Henjum S, Faksvåg PK, Saether EM, et al. Effect of a pharmacist-led intervention on adherence among patients with a first-time prescription for a cardiovascular medicine: a randomized controlled trial in Norwegian pharmacies. Int J Pharm Pract. 2020;28(4):337-345. doi: 10.1111/ijpp.12598.

Fraeyman J, Foulon V, Mehuys E, Boussery K, Saevels J, De Vriese C, et al. Evaluating the implementation fidelity of New Medicines Service for asthma patients in community pharmacies in Belgium. Res Social Adm Pharm. 2017;13(1):98-108. doi: 10.1016/j.sapharm.2016.02.001.

Wells KM, Thornley T, Boyd MJ, Boardman HF. Views and experiences of community pharmacists and superintendent pharmacists regarding the New Medicine Service in England prior to implementation. Res Social Adm Pharm. 2014;10(1):58-71. doi: 10.1016/j.sapharm.2013.03.003.

Evans CD, Eurich DT, Taylor JG, Remillard AJ, Shevchuk YM, Blackburn DF. A pragmatic cluster randomized trial evaluating the impact of a community pharmacy intervention on statin adherence: rationale and design of the Community Pharmacy Assisting in Total Cardiovascular Health (CPATCH) study. Trials. 2010;11:76. doi: 10.1186/1745-6215-11-76.

Barber N, Parsons J, Clifford S, Darracott R, Horne R. Patients’ problems with new medication for chronic conditions. Qual Saf Health Care. 2004;13(3):172-5. doi: 10.1136/qhc.13.3.172.

Clifford S, Barber N, Elliott R, Hartley E, Horne R. Patient-centred advice is effective in improving adherence to medicines. Pharm World Sci. 2006;28(3):165-70. doi: 10.1007/s11096-006-9026-6.

Blake RL Jr, McKay DA. A single-item measure of social supports as a predictor of morbidity. J Fam Pract. 1986;22(1):82-4. PMID: 3941304.

Valverde-Merino MI, Martinez-Martinez F, Garcia-Mochon L, Benrimoj SI, Malet-Larrea A, Perez-Escamilla B, et al. Cost-Utility Analysis of a Medication Adherence Management Service Alongside a Cluster Randomized Control Trial in Community Pharmacy. Patient Prefer Adherence. 2021;15:2363-2376. doi: 10.2147/PPA.S330371.

Agusti A, Soler JJ, Molina J, et al. Is the CAT questionnaire sensitive to changes in health status in patients with severe COPD exacerbations? COPD. 2012;9(5):492-498. doi:10.3109/15412555.2012.692409

Ruiz MA, Pardo A, Rejas J, Soto J, Villasante F, Aranguren JL. Development and Validation of the “Treatment Satisfaction with Medicines Questionnaire”(SATMED‐Q)©. Value Heal. 2008;11(5):913-926.

Martin-Ruiz E, Olry-de-Labry-Lima A, Ocaña-Riola R, Epstein D. Systematic Review of the Effect of Adherence to Statin Treatment on Critical Cardiovascular Events and Mortality in Primary Prevention. J Cardiovasc Pharmacol Ther. 2018;23(3):200-215. doi:10.1177/1074248417745357

Husereau D, Drummond M, Augustovski F, de Bekker-Grob E, Briggs AH, Carswell C, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 Explanation and Elaboration: A Report of the ISPOR CHEERS II Good Practices Task Force. Value Health. 2022;25(1):10-31. doi: 10.1016/j.jval.2021.10.008.

López Bastida J, Oliva J, Antoñanzas F, García-Altés A, Gisbert R, Mar J, et al. Propuesta de guía para la evaluación económica aplicada a las tecnologías sanitarias. Gac Sanit. 2010;24(2):154-70. doi: 10.1016/j.gaceta.2009.07.011.

ORDEN de 14 de octubre de 2005, por la que se fijan los precios públicos de los servicios sanitarios prestados por Centros dependientes del Sistema Sanitario Público de Andalucía. Available from: https://juntadeandalucia.es/boja/2005/210/boletin.210.pdf. Accessed: February 19, 2022.

Base de Datos de Medicamentos-BotPlus 2.0. General pharmaceutical council of Spain. Available from: https://botplusweb.portalfarma.com/. Accessed April 3, 2022.

Faria R, Gomes M, Epstein D, White IR. A guide to handling missing data in cost-effectiveness analysis conducted within randomised controlled trials. Pharmacoeconomics. 2014;32(12):1157-1170. doi: 10.1007/s40273-014-0193-3.

Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337:a1655. doi:10.1136/bmj.a1655

Wells KM, Boyd MJ, Thornley T, Boardman HF. What proportion of prescription items dispensed in community pharmacies are eligible for the new medicine service? BMC Health Serv Res. 2014;14:1-6. doi:10.1186/1472-6963-14-115

Adunlin G, Murphy PZ, Manis M. COVID-19: How Can Rural Community Pharmacies Respond to the Outbreak? J Rural Health. 2021;37(1):153-155. doi: 10.1111/jrh.12439.

Jordan D, Guiu-Segura JM, Sousa-Pinto G, Wang LN. How COVID-19 has impacted the role of pharmacists around the world. Farm Hosp. 2021;45(2):89-95. doi: 10.7399/fh.11652.