Analysis of over-the-counter medicines’ information and strategies oriented to the community for improving its access and quality.
DOI:
https://doi.org/10.31053/1853.0605.v75.n4.21599Keywords:
nonprescription drugs, package inserts for the patient, access to information, consumer health information, community pharmacy servicesAbstract
Introduction
The Disposición ANMAT 753/2012 states definitions and guidelines about the information that inserts and labels must include in nonprescription drugs (also known as over-the-counter or OTC drugs).
Aims: to analyze the adequacy to the norm in a sample of OTC drugs; promote and disseminate strategic viable actions for being developed by pharmacists to improve the patient’s information.
Methods
During a course destined to community pharmacists, a practical activity and an on-line forum about the adequacy to the Disposición ANMAT 753/2012 were developed. The compliance of 17 requirements of the norm, in a sample of 66 OTC drugs, was registered. Forum duration: 2 weeks. A content analysis related to the strategies proposed by the participants was conducted.
Results
From the sample, 87.9% of the medicines do not accomplish to at least 1 of the requirements. The major noncompliances were: inappropriately described composition, lack of telephone number for consultations, uncomprehensible therapeutic action, and package requirements. Strategies to develop by pharmacies individually, grouped, or through professional associations were formulated.
Conclusion
A high level of noncompliance in the analyzed aspects of the norm was observed. The strategies proposed are oriented to patient empowerment by health education about OTC drugs and access to reliable information resources, comprehensible for consumers. It is necessary to reinforce the control procedures for the information the OTC drugs must include, and to encourage both the participation and commitment of the pharmacist.
Downloads
References
Ley de Medicamentos, Ley Nacional 16463, Poder Ejecutivo Nacional, República Argentina (Agosto 08, 1964).
Reglamentación de la Ley 16463, Decreto Nº 9763/1964 Poder Ejecutivo Nacional, República Argentina (Diciembre 07, 1964).
Tong V, Raynor DK, Aslani P. Receipt and use of spoken and written over-the-counter medicine information: insights into Australian and UK consumers' experiences. Int J Pharm Pract. 2018;26(2):129-137.
Cardoso P, Curbelo J, Palazzesi A, Álvarez G, Cargnel E. Comprensibilidad de un prospecto de medicamento de venta libre. Rev Argent Salud Pública. 2012; 3(13):30-35
Tong V, Raynor DK, Aslani P. Design and comprehensibility of over-the-counter product labels and leaflets: a narrative review. Int J Clin Pharm. 2014;36(5):865-72.
Confederación Farmacéutica Argentina (COFA) [Internet] n.d. Informe 2016 – Parte I. [Consultado 19 de julio 2018]. Disponible en: http://www.cofa.org.ar/?p=20359y
Fuchs J, Hippius M, Schaefer M. Analysis of German package inserts. Int J Clin Pharmacol Ther. 2006;44:8-13.
March Cerdá JC, Prieto Rodríguez MA, Ruiz Azarola A, Simón Lorda P, Barrio Cantalejo I, Danet A. Mejora de la información sanitaria contenida en los prospectos de los medicamentos: expectativas de pacientes y de profesionales sanitarios Aten Primaria 2010;42(1):22-7.
González de Cossio M. Nuevas etiquetas de medicamentos para apoyar la automedicación en México. El caso de un analgésico pediátrico. Salud Pública de México. 2008;50(supl. 4).
Guidance for Industry. Label Comprehension Studies for Nonprescription Drug Products. U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research; April 2009.
Guideline on the Readability of the Labelling and Package Leaflet of Medicinal Products for Human Use. European Commission. Enterprise and Industry Directorate-General. Bruselas; 2009.
Definiciones y Lineamientos Generales de la información que deberán contener los prospectos/etiquetas/rótulos de especialidades medicinales de condición de venta libre, Disposición 753/2012, Administración Nacional de Medicamentos, Alimentos y Tecnología Médica, Ministerio de Salud y Ambiente, República Argentina (febrero, 2012) [acceso: 05/07/2017]. Disponible en: http://servicios.infoleg.gob.ar/infolegInternet/anexos/190000-194999/194057/norma.htm
Colegio de Farmacéuticos de Córdoba. Curso on line “Gestión de Servicios Profesionales Farmacéuticos (SPF): Parte 1: Indicación Farmacéutica” [acceso: 02/10/2017]. Disponible en: https://colfacor.educativa.com
Hancock B, Windridge K, Ockleford E. An Introduction to Qualitative Research. The NIHR RDS EM / YH, 2007.
Centers for Disease Control and Prevention. Analyzing Qualitative Data for Evaluation [Internet]. Evaluation Briefs 19. EEUU: CDC, Department of Health and Human Services; 2009 [acceso: 30/05/2018]. Disponible en: https://www.cdc.gov/healthyyouth/evaluation/pdf/brief19.pdf
Cavaco AM, Dias JP, Bates IP. Consumers' perceptions of community pharmacy in Portugal: a qualitative exploratory study. Pharm World Sci. 2005;27(1):54-60.
Tong V, Raynor DK, Aslani P. Comparative User Testing of Australian and UK Over-the-Counter Labels and Leaflets for Diclofenac. Ther Innov Regul Sci. 2018;52(1):38-48.
Barrio IM, Simón-Lorda P, Melguizo M, Molina A. Consenso sobre los criterios de legibilidad de los folletos de educación para la salud. An Sist Sanit Navar.2011;34(2):153-165.
Lampert A, Wien K, Haefeli WE, Seidling HM. Guidance on how to achieve comprehensible patient information leaflets in four steps. Int J Qual Health Care. 2016;28(5):634-638.
Young A, Tordoff J, Smith A. 'What do patients want?' Tailoring medicines information to meet patients' needs. Res Social Adm Pharm. 2017;13(6):1186-1190.
OPS/OMS. Servicios farmacéuticos basados en la atención primaria de salud. SERIE La Renovación de la Atención Primaria de Salud en las Américas N 6. Washington DC: OPS; 2013.
Armando P, Tenllado MI, Martínez P, Uema SAN. Estrategias para fomentar un adecuado compromiso del farmacéutico con respecto a la publicidad de medicamentos de venta libre. Rev Fac Cien Med Univ Nac Cordoba. 2018. En prensa.
Hamrosi KK, Raynor DK, Aslani P. Enhancing provision of written medicine information in Australia: pharmacist, general practitioner and consumer perceptions of the barriers and facilitators. BMC Health Serv Res. 2014 23;14:183.
Ryan R, Santesso N, Lowe D, Hill S, Grimshaw J, Prictor M et al. Interventions to improve safe and effective medicines use by consumers: an overview of systematic reviews. Cochrane Database Syst Rev. 2014 29;(4):CD007768.
Raynor DK, Blenkinsopp A, Knapp P, Grime J, Nicolson DJ, Pollock K 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.
Additional Files
Published
How to Cite
Issue
Section
License
The Faculty of Medical Sciences Journal (RFCM) subscribes to the Open Access policy and does not charge authors fees for publishing, nor does it charge readers fees for accessing published articles (APC).
