Pharmacovigilance

an evaluation on the practice of pharmacists acting in pharmacies and drugstores

Authors

  • Mayra Bruna Fedalto Department of Pharmacy, Federal University of Paraná, Curitiba, Parana, Brazil
  • Fernanda Stumpf Tonin Department of Pharmacy, Federal University of Paraná, Curitiba, Parana, Brazil; Research Institute for Medicines (iMed.ULisboa), Department of Social Pharmacy, Faculty of Pharmacy, University of Lisbon, Lisbon, Portugal
  • Helena Hiemisch Lobo Borba Department of Pharmacy, Federal University of Paraná, Curitiba, Paraná, Brazil
  • Vinicius Lins Ferreira Department of Pharmacy, Federal University of Paraná, Curitiba, Parana, Brazil
  • Cassyano Januário Correr Department of Pharmacy, Federal University of Paraná, Curitiba, Paraná, Brazil
  • Fernando Fernandez-Llimos Research Institute for Medicines (iMed.ULisboa), Department of Social Pharmacy, Faculty of Pharmacy, University of Lisbon, Lisbon, Portugal; Laboratory of Pharmacology, Department of Drug Sciences, Faculty of Pharmacy, University of Porto, Porto, Portugal
  • Roberto Pontarolo Department of Pharmacy, Federal University of Paraná, Curitiba, Parana, Brazil

DOI:

https://doi.org/10.1590/

Keywords:

Pharmacovigilance, Notifications, Pharmacists, Pharmacies, Drugstores

Abstract

Pharmacists acting in pharmacies and drugstores stores are some of the most accessible healthcare providers and the last to intervene before the patient takes their medicine. This puts the pharmacist in a position of authority that should be harnessed for the benefit of health. Thus, this professional is strategic for performing pharmacovigilance. Our objective of this study was to interrogate the practice of pharmacists in relation to pharmacovigilance activities, and to identify difficulties and possible stimuli for the improvement these activities in pharmacies and drugstores. The information was collected through an online questionnaire via Survey Monkey®. The data were analyzed statistically using SPSS software. Responses were received from 5174 pharmacists: mostly young women within five years of graduation and experience in pharmaceutical retail. 81% of them reported having identified suspected substandard medicines, but only 16% used the Brazilian notification system Notivisa. More than 85% of pharmacists agreed with the importance of pharmacovigilance and the recognition of reporting services as part of pharmacist duties and pharmaceutical care. The main barriers to making notifications were the lack of access and knowledge about Notivisa. Pharmacists agreed that simplifying the system would be a stimulus for notifications, and requested more feedback from notifications, as well as material and courses to understand the notification process. Pharmacists have important data to feed into pharmacovigilance systems, recognize their responsibilities and are willing to contribute, but still demonstrate low compliance. Simplification of the system and training on it are likely to increase notifications.

Downloads

References

AbdulRazzaq HA, Aziz NA, Sulaiman SAS, Hassan Y, Kassab YW, Ismail O. Adverse drug reactions of statin based on patients’ self reports. J Pharm Res. 2012;5(2):864-868.

Al-Worafi YM, Kassab YW, Alseragi WM, Almutairi MS, Ahmed A, Ming LC, et al. Pharmacovigilance and adverse drug reaction reporting: a perspective of community pharmacists and pharmacy technicians in Sana’a, Yemen. Ther Clin Risk Manag. 2017;13:1175-1181.

Amrita P, Roomi MT. Scenario of Pharmacovigilance and ADR Reporting among Pharmacists in Delhi. Int J Pharm Pract. 2011;4(4):29-38.

Bawazir SA. Attitude of community pharmacists in Saudi Arabia towards adverse drug reaction reporting. Saudi Pharm J. 2006;14:75-83.

Bonal J. Los limites del rol del farmacéutico: hasta dónde debemos ir?. Pharm Care Esp. 2001;2:230-232.

Boynton PM. Administering, analysing, and reporting your questionnaire. BMJ. 2004;328(7452):1372-1375.

Brasil. Ministério da Saúde, Agência Nacional de Vigilância Sanitária. Lei n°13.021, de 8 de agosto de 2014. Dispõe sobre o exercício e a fiscalização das atividades farmacêuticas, 2014. [citad 2020 Aug 01].Available from: Available from: https://www.planalto.gov.br/ccivil_03/_Ato2011-2014/2014/Lei/L13021.htm#:~:text=Dispõe sobre o exercício e a fiscalização das atividades farmacêuticas.&text=Art.,de direito público ou privado

» https://www.planalto.gov.br/ccivil_03/_Ato2011-2014/2014/Lei/L13021.htm#:~:text=Dispõe sobre o exercício e a fiscalização das atividades farmacêuticas.&text=Art.,de direito público ou privado

Brasil. Ministério da Educação. Resolução nº 6, de 19 de outubro de 2017. Institui as Diretrizes Curriculares Nacionais do Curso de Graduação em Farmácia e dá outras providências, 2017. [citad 2020 Aug 01]. Available from:Available from:https://www.in.gov.br/materia/-/asset_publisher/Kujrw0TZC2Mb/content/id/19363913/do1-2017-10-20- resolucao-n-6-de-19-de-outubro-de-2017-19363904

» https://www.in.gov.br/materia/-/asset_publisher/Kujrw0TZC2Mb/content/id/19363913/do1-2017-10-20- resolucao-n-6-de-19-de-outubro-de-2017-19363904

Brasil. Ministério da Saúde, Agência Nacional de Vigilância Sanitária. Informe n° 01/2019. Orientações para notificação no sistema VigiMed, 2019. [citad 2020 Mar 15]. Available from: Available from: http://portal.anvisa.gov.br/informacoes-tecnicas13?p_p_id=101_INSTANCE_WvKKx2fhdjM2&p_p_col_id=column-2&p_p_col_count=1&_101_INSTANCE_ WvKKx2fhdjM2_groupId=33868&_101_INSTANCE_WvKKx2fhdjM2_urlTitle=orientacoes-para-solicitacao-de-cadastro-ao-sistema-vigimed&_101_INSTANCE_WvKKx2fhdjM2_struts_action=%2Fasset_publisher%2Fview_content&_101_INSTANCE_WvKKx2fhdjM2_assetEntryId=5720370&_101_INSTANCE_WvKKx2fhdjM2_type=content

» http://portal.anvisa.gov.br/informacoes-tecnicas13?p_p_id=101_INSTANCE_WvKKx2fhdjM2&p_p_col_id=column-2&p_p_col_count=1&_101_INSTANCE_ WvKKx2fhdjM2_groupId=33868&_101_INSTANCE_WvKKx2fhdjM2_urlTitle=orientacoes-para-solicitacao-de-cadastro-ao-sistema-vigimed&_101_INSTANCE_WvKKx2fhdjM2_struts_action=%2Fasset_publisher%2Fview_content&_101_INSTANCE_WvKKx2fhdjM2_assetEntryId=5720370&_101_INSTANCE_WvKKx2fhdjM2_type=content

Brasil. Ministério da Saúde, Agência Nacional de Vigilância Sanitária. Notificações em Vigilância Sanitária - NOTIVISA, 2020 [citad 2020 Mar 16]. Available from: Available from: http://portal.anvisa.gov.br/notivisa

» http://portal.anvisa.gov.br/notivisa

Canibal NA, Firmino BAM, Castilho JC. Farmacovigilância em farmácias e drogarias: situação atual. Rev Intellectus. 2017;1(37).

Chisholm-Burns MA, Zivin JG, Lee J K, Spivey CA, Slack MK, Herrier RN, et al. Economic effects of pharmacists on health outcomes in the United States: A systematic review. Am J Health Syst Pharm. 2010;67(19):1624-1634.

Conselho Federal de Farmácia (CFF). Dados 2018. 2018. [citad 2020 July 10]. Available from: Available from: https://www.cff.org.br/pagina.php?id=801&menu=801&titulo=Dados+2018

» https://www.cff.org.br/pagina.php?id=801&menu=801&titulo=Dados+2018

Correr CJ, Rossignoli P, Souza R, Pontarolo R. Perfil de los farmacéuticos e indicadores de estrutura y proceso en farmacias de Curitiba - Brasil. Seguimiento Farmacoterapéutico. 2004;2(1)37-45.

Dalton K, Byrne S. Role of the pharmacist in reducing healthcare costs: current insights. Integr Pharm Res Pract. 2017;6:37-46.

Fernandes BD, de Freitas RR, Melchiors AC. Evaluation of pharmaceutical services: Structure and process indicators in community pharmacies. Rev Bras Pesq Saúde. 2015;17(1):31-37.

Hughes CM, Hawwa AF, Scullin C, Anderson C, Bernsten CB, Björnsdóttir I, et al. Provision of pharmaceutical care by community pharmacists: a comparison across Europe. Pharm World Sci. 2010;32(4):472-487.

Hajj A, Hallit, S, Ramia E, Salameh P. Medication safety knowledge, attitudes and practices among community pharmacists in Lebanon. Curr Med Res Opin. 2018;34(1):149-156.

Júnior Hipólito EH, Halila GC, Reis WCT, Guimarães MM, Guanaes LD, Pontarolo R, et al. Quality indicators of pharmacists’ services in community pharmacies in Paraná State, Brazil. Braz J Pharm Sci. 2017;53(1).

Li R, Curtain C, Bereznicki L, Zaidi STR. Community pharmacists’ knowledge and perspectives of reporting adverse drug reactions in Australia: a cross-sectional survey. Int J Clin Pharm. 2018;40(4):878-889.

Laven A, Schmitz K, Franzen WH. Reporting Adverse Drug Reactions: Contribution, Knowledge and Perception of German Pharmacy Professionals. Int J Clin Pharm . 2018;40(4):842-851.

Mahmoud MA, Alsowaida Y, Alshammari T, Khan TM, Alrasheedy A, Hassali MA, et al. Community pharmacists’ knowledge, behaviors and experiences about adverse drug reaction reporting in Saudi Arabia. Saudi Pharm J . 2014;22(5):411-418.

Oreagba IA, Ogunleye OJ, Olayemi SO. The knowledge, perceptions and practice of pharmacovigilance amongst community pharmacists in Lagos state, south west Nigeria. Pharmacoepidemiol Drug Saf. 2011;20(1):30-35.

Prakasam A, Nidamanuri A, Kumar S. Knowledge, perception and practice of pharmacovigilance among community pharmacists in South India. Pharm Pract. 2012;10(4):222-226)

Ribeiro-Vaz I, Herdeiro MT, Polónia J, Figueiras A. Estratégias para aumentar a sensibilidade da farmacovigilância em Portugal. Rev de Saúde Pública. 2011;45(1):129-135.

Said ASA, Hussain N. Adverse drug reaction reporting practices among United Arab Emirates. Hosp Pharm. 2017;52(5):361-366.

Smith MP, Webley, SD. Pharmacovigilance teaching in UK undergraduate pharmacy programmes. Pharmacoepidemiol Drug Saf . 2013;22(3):223-8.

Tribunal de Contas da União (TCU). Auditoria operacional no controle pós-registro de medicamentos. 2016. [citad 2019 Dec 15]. Available from: Available from: https://portal.tcu.gov.br/biblioteca-digital/auditoria-operacional-no-controle-pos-registro-de-medicamentos.htm

» https://portal.tcu.gov.br/biblioteca-digital/auditoria-operacional-no-controle-pos-registro-de-medicamentos.htm

Tsuchiya M, Obara T, Sakai T, Nomura K, Takamura C, Mano N. Quality evaluation of the Japanese Adverse Drug Event Report database (JADER). Pharmacoepidemiol Drug Saf . 2019;1-9.

Varallo FR, Planeta CS, Mastroianni PC. Effectiveness of pharmacovigilance: multifaceted educational intervention related to the knowledge, skills and attitudes of multidisciplinary hospital staff. Clinics. 2017;72(1):51-57.

Vessal G, Mardani Z, Mollai M. Knowledge, attitudes, and perceptions of pharmacists to adverse drug reaction reporting in Iran. Pharm World Sci . 2009;31:183-187.

World Health Organization. WHO. The Importance of Pharmacovigilance - Safety Monitoring of Medicinal Products, Genebra: World Health Organization; 2002. 52 p.

Yu YM, Lee E, Koo BS, Jeong KH, Choi KH, Kang LK, et al. Predictive Factors of Spontaneous Reporting of Adverse Drug Reactions among Community Pharmacists. PLOS ONE, 2016;11(5).

Downloads

Published

2022-11-25

Issue

Section

Article

How to Cite

Pharmacovigilance: an evaluation on the practice of pharmacists acting in pharmacies and drugstores. (2022). Brazilian Journal of Pharmaceutical Sciences, 58. https://doi.org/10.1590/