Drug quality deviations: notifications in a sentinel hospital in Ceará

Objective: To characterize the drug quality deviation (DQM) notification and their financial impact of a sentinel network university hospital in Ceará. Methods: This is a cross-sectional observational pharmacovigilance study carried out in Fortaleza-CE, through spontaneous reports of DQM from Janua...

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Autores principales:	Elana F. CHAVES, Juliana A. GUIMARÃES, Antonia M. MORORÓ, Bruna C. MARTINS, Andreína F. TEIXEIRA
Formato:	article
Lenguaje:	EN PT
Publicado:	Sociedade Brasileira de Farmácia Hospitalar e Serviços de Saúde 2020
Materias:	Public aspects of medicine RA1-1270 Pharmacy and materia medica RS1-441 Therapeutics. Pharmacology RM1-950
Acceso en línea:	https://doaj.org/article/e48d337e490845aab694df76124ecfcb
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spelling	oai:doaj.org-article:e48d337e490845aab694df76124ecfcb2021-11-28T02:44:39ZDrug quality deviations: notifications in a sentinel hospital in Ceará10.30968/rbfhss.2020.113.04892179-59242316-7750https://doaj.org/article/e48d337e490845aab694df76124ecfcb2020-09-01T00:00:00Zhttps://www.rbfhss.org.br/sbrafh/article/view/489https://doaj.org/toc/2179-5924https://doaj.org/toc/2316-7750 Objective: To characterize the drug quality deviation (DQM) notification and their financial impact of a sentinel network university hospital in Ceará. Methods: This is a cross-sectional observational pharmacovigilance study carried out in Fortaleza-CE, through spontaneous reports of DQM from January 2016 to June 2017. Data was obtained from the patient’s records, registered and analyzed using Excel spreadsheets. Results: A total of 49 (84.48%) reports were included in this study, with a monthly average of 2.72 notifications. These came mainly from the pharmacy (n=14; 28.57%) and medical clinics (n=12; 24.49%), with nurses (n=28; 57.14%) and pharmacists (n=13; 26.53%) being the largest notifiers. A total of 92 drugs were used, being blood substitutes and perfusion solutions (n=50; 54.35%), antibacterials for systemic use (n=12; 13.04%) and immunoglobulins (n=6; 6.52%) the most frequent. Injectable pharmaceutical formulations were more frequent (91,30%; n=84). The most frequently observed DQM were the presence of foreign body / material in suspension (n=16; 32.65%) and crack / bubble / leak (n=14; 28.57%). The supplier was contacted in em 65,31% (n=32), of the cases, with formal responses received in 65,62% (n=21) of them. The manufacturer took responsibility for DQM in 38,10% (n=8) of cases. The notification to the National Health Surveillance Agency (ANVISA) occurred in 20,41% of the cases. The reimbursement of the value of the drug by the producer laboratories contacted occurred in 25% (n=8) of the cases, corresponding to a value of R $ 4,254.97. Conclusions: The importance of conducting DQM notifications is evident since these can ensure better knowledge about health products on the market and safer products for patients and health professionals. Elana F. CHAVESJuliana A. GUIMARÃESAntonia M. MORORÓBruna C. MARTINSAndreína F. TEIXEIRASociedade Brasileira de Farmácia Hospitalar e Serviços de SaúdearticlePublic aspects of medicineRA1-1270Pharmacy and materia medicaRS1-441Therapeutics. PharmacologyRM1-950ENPTRevista Brasileira de Farmácia Hospitalar e Serviços de Saúde, Vol 11, Iss 3 (2020)
institution	DOAJ
collection	DOAJ
language	EN PT
topic	Public aspects of medicine RA1-1270 Pharmacy and materia medica RS1-441 Therapeutics. Pharmacology RM1-950
spellingShingle	Public aspects of medicine RA1-1270 Pharmacy and materia medica RS1-441 Therapeutics. Pharmacology RM1-950 Elana F. CHAVES Juliana A. GUIMARÃES Antonia M. MORORÓ Bruna C. MARTINS Andreína F. TEIXEIRA Drug quality deviations: notifications in a sentinel hospital in Ceará
description	Objective: To characterize the drug quality deviation (DQM) notification and their financial impact of a sentinel network university hospital in Ceará. Methods: This is a cross-sectional observational pharmacovigilance study carried out in Fortaleza-CE, through spontaneous reports of DQM from January 2016 to June 2017. Data was obtained from the patient’s records, registered and analyzed using Excel spreadsheets. Results: A total of 49 (84.48%) reports were included in this study, with a monthly average of 2.72 notifications. These came mainly from the pharmacy (n=14; 28.57%) and medical clinics (n=12; 24.49%), with nurses (n=28; 57.14%) and pharmacists (n=13; 26.53%) being the largest notifiers. A total of 92 drugs were used, being blood substitutes and perfusion solutions (n=50; 54.35%), antibacterials for systemic use (n=12; 13.04%) and immunoglobulins (n=6; 6.52%) the most frequent. Injectable pharmaceutical formulations were more frequent (91,30%; n=84). The most frequently observed DQM were the presence of foreign body / material in suspension (n=16; 32.65%) and crack / bubble / leak (n=14; 28.57%). The supplier was contacted in em 65,31% (n=32), of the cases, with formal responses received in 65,62% (n=21) of them. The manufacturer took responsibility for DQM in 38,10% (n=8) of cases. The notification to the National Health Surveillance Agency (ANVISA) occurred in 20,41% of the cases. The reimbursement of the value of the drug by the producer laboratories contacted occurred in 25% (n=8) of the cases, corresponding to a value of R $ 4,254.97. Conclusions: The importance of conducting DQM notifications is evident since these can ensure better knowledge about health products on the market and safer products for patients and health professionals.
format	article
author	Elana F. CHAVES Juliana A. GUIMARÃES Antonia M. MORORÓ Bruna C. MARTINS Andreína F. TEIXEIRA
author_facet	Elana F. CHAVES Juliana A. GUIMARÃES Antonia M. MORORÓ Bruna C. MARTINS Andreína F. TEIXEIRA
author_sort	Elana F. CHAVES
title	Drug quality deviations: notifications in a sentinel hospital in Ceará
title_short	Drug quality deviations: notifications in a sentinel hospital in Ceará
title_full	Drug quality deviations: notifications in a sentinel hospital in Ceará
title_fullStr	Drug quality deviations: notifications in a sentinel hospital in Ceará
title_full_unstemmed	Drug quality deviations: notifications in a sentinel hospital in Ceará
title_sort	drug quality deviations: notifications in a sentinel hospital in ceará
publisher	Sociedade Brasileira de Farmácia Hospitalar e Serviços de Saúde
publishDate	2020
url	https://doaj.org/article/e48d337e490845aab694df76124ecfcb
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Drug quality deviations: notifications in a sentinel hospital in Ceará

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