Keywords
COVID-19
Pharmacovigilance
Patient Safety
Systematic Review
How to Cite
Abstract
The aim was to outline the protocol for carrying out the systematic review, which will have the objective of evaluating the impact of the COVID-19 pandemic on notifications of adverse drug events to health authorities worldwide. This is a systematic review protocol consistent with PRISMA 2020 regulations and checklist, will be conducted in accordance with the recommendations of the Cochrane Manual, will include original observational studies, letters to editors and editorials containing summary information on adverse drug events before and during the COVID-19 pandemic. The search strategy was developed for the MEDLINE, Embase, CINALH, SciELO and gray literature databases, using the Health Sciences Descriptors (DECs) and the Medical Subject Heading (MeSH). Two independent reviewers will investigate the eligibility of the articles, extract the data and assess the risk of bias. The results of this review will contribute to identifying the impact of COVID-19 on adverse drug event reporting, this will be a significant step in informing and preventing such events and will provide an essential evidence base for the development of strategies and improvements that will contribute to patient safety worldwide.
References
World Health Organization (WHO). Patient Safety [Internet]. WHO; 2019. [acesso em 20 set 2021]. Disponível em: https://www.who.int/news-room/fact-sheets/detail/patient-safety
World Health Organization (WHO). Medication without harm WHO global patient safety challenge [Internet] Australian (AU): WHO; 2019 [acesso em 20 set 2021]. Disponível em: https://www.who.int/initiatives/medication-without-harm
World Health Organization (WHO). Draft Global patient safety action plan 2021–2030: towards zero patient harm in health care [Internet]. Geneva (GE): WHO; 2020 [acesso em 21 set 2021]. Disponível em: https://www.who.int/docs/default-source/patient-safety/1st-draft-global-patient-safety-action-plan-august-2020.pdf?sfvrsn=9b1552d2_4
Agency for Healthcare Research and Quality (AHRQ). Medication errors and adverse drug events [Internet].Fishers Lane (MD); 2019 [acesso em 21 set 2021]. Disponível em: https://psnet.ahrq.gov/primer/medication-errors-and-adverse-drug-events
Furini ACA, Nunes AA, Dallora MELV. Notificação de eventos adversos: caracterização dos eventos ocorridos em um complexo hospitalar. Revista Gaúcha de Enfermagem. 2019;40(spe). DOI: 10.1590/1983-1447.2019.20180317
World Health Organization (WHO). Patient Safety Incident Reporting and Learning Systems: technical report and guidance [Internet]. Geneva (GE): WHO; 2020 [acesso em 21 set 2021]. Disponível em: https://www.who.int/publications/i/item/9789240010338
World Health Organization (WHO). Medications without harm-Global Patient Safety Challenge on Medication Safety [Internet]. Genova (IT): WHO; 2017 [acesso em 20 set 2021]. Disponível em: https://apps.who.int/iris/bitstream/handle/10665/255263/WHO-HIS-SDS-2017.6-eng.pdf
Noronha JC. Cobertura universal de saúde: como misturar conceitos, confudir objetivos, abandonar princípios. Perspectivas. Cad. Saúde Pública. 2013;29(5). DOI: 10.1590/S0102-311X2013000500003
World Health Organization (WHO). Patient safety: global action on patient safety. Seventy-second World Health Assembly A72/26 [Internet]. Genebra (GE): WHO; 2019 [acesso em 20 set 2021]. Disponível em: https://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_26-en.pdf
Agência Nacional de Vigilância Sanitária (Anvisa). Boletim de farmacovigilância n°7: Subnotificação de suspeitas de reações adversas a medicamentos [Internet]. Brasília (DF): Anvisa; 2019. [acesso em 20 de set de 2021]. Disponivel em: Farmacovigilância: 7º Boletim trata de subnotificação - cosmetovigilancia – Anvisa
Staines A, Amalberti R, Berwick DM, Braithwaite J, Peter Lachman, Vincent CA. COVID-19: patient safety and quality improvement skills to deploy during the surge. International Journal for Quality in Health Care. 2020;33(1). DOI: 10.1093/intqhc/mzaa050
Cabral FF, Pereira MB, Borges KDM, Passos ACB, Francelino EV, Monteiro MP, et al. Evento adversos a medicamentos no tratamento da covid-19 no Ceará. Revista Ciência [Internet]. 2020 [acesso em 20 set 2021];14(1). Disponível em: //cadernos.esp.ce.gov.br/index.php/cadernos/article/view/401
Vaismoradi M, Logan PA, Jordan S, Sletvold H. Adverse drug reactions in Norway: A sytematic review. Pharmacy (Basel). 2019. DOI: 10.3390/pharmacy7030102
Li R, Zaidi SRZ, Chen T, Castelino R. Effectiveness of interventions to improve adverse drug reaction reporting by healthcare professionals over the last decade: A systematic review. Pharmacoepidemiol Drug Safety. 2020. DOI: 10.1002/pds.4906
Page MJ, McKenzie JE, Bossuyt PM,Boultron I, Hoffmann TC, Mulrow CD et al. The PRISMA 2020 statement: an update guideline for reporting systematic reviews. BMJ. 2021. DOI: 10.1136/bmj.n71
Higgins J, Thomas J, Chandler J, Cumpston M, Li T, et al. Cochrane Handbook for systematic reviews of interventions. Cochrane Training. [E-book] 2020. [acesso em 20 set 2021]. Disponível em: https://training.cochrane.org/handbook
Kesselheim AS, Misono AS, Lee JL, Stedman MR, Brookhart A, Choudhry NK, et al. Clinical equivalence os generic and brand-name drugs used in cardiovascular disease: a sytematic review and meta-analysis. JAMA. 2008. DOI: 10.1001/jama.2008.758
Sterne JAC, Hernán MA, Reeves BC, Savović J, Berkman ND, Viswanathan M, et al. ROBINS-I: a tool for assessing risk of bias in non-randomized studies - of Interventions. BMJ;2016. DOI: 10.1136/bmj.i4919
Sterne JA, Hernán MA, Aleenan AM, reeves BC, Higgins JP. Chapter 25: Assessing risk of bias in a non-randomized study. Cochrane Training [Internet] 2020. [acesso em 20 set 2021]. Disponível em: https://training.cochrane.org/handbook/current/chapter-25
Mota DM, Vigo A, Kuchenbecker RS. Reações adversas a medicamentos no sistema de farmacovigilância do Brasil, 2008 a 2013: estudo descritivo. Cad. Saúde Pública. 2019;30(8). DOI: 10.1590/0102-311X00148818
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