Pharmacovigilance of quality deviations in the public healthcare system

Drug quality deviation (DQD) is the disagreement with the parameters at the registration with after commercialization step. Pharmacovigilance programs should be notified of DQD to ensure drug efficacy and support patient safety. Objective: To describe DQD from public healthcare system and its im...

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Autores principales:	Carolina Resende Bitencourt, Cristiane Aparecida Menezes De Pádua, Paula Lana De Miranda Drummond, Edson Perini
Formato:	article
Lenguaje:	EN PT
Publicado:	Sociedade Brasileira de Farmácia Hospitalar e Serviços de Saúde 2019
Materias:	Public aspects of medicine RA1-1270 Pharmacy and materia medica RS1-441 Therapeutics. Pharmacology RM1-950
Acceso en línea:	https://doaj.org/article/b5da99e20a1c4a8a97b339708dbc50ab
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spelling	oai:doaj.org-article:b5da99e20a1c4a8a97b339708dbc50ab2021-11-28T02:46:27ZPharmacovigilance of quality deviations in the public healthcare system10.30968/rbfhss.2018.094.0042179-59242316-7750https://doaj.org/article/b5da99e20a1c4a8a97b339708dbc50ab2019-11-01T00:00:00Zhttps://www.rbfhss.org.br/sbrafh/article/view/385https://doaj.org/toc/2179-5924https://doaj.org/toc/2316-7750 Drug quality deviation (DQD) is the disagreement with the parameters at the registration with after commercialization step. Pharmacovigilance programs should be notified of DQD to ensure drug efficacy and support patient safety. Objective: To describe DQD from public healthcare system and its impact on the pharmaceutical service. Methods: Descriptive analysis of DQD recorded at Belo Horizonte primary and secondary care facilities, from April to September 2016. Variables: Type of DQD, pharmaceutical product, therapeutic class, notifying health unit, risk classification, and reply of DQD notification. This analysis was described by measures of central tendency and dispersion. Results: 329 DQD in 271 notifications were recorded leading to a loss of 9,311 preparations, representing on average 0.2% of the purchased lot. Most DQD were recorded at the primary health care level in solid preparations. Drug-related problems included deviations in package content (47%), package integrity (26%), label (5%), and pharmaceutical product itself (22%). Anti-infectives for systemic use (21%) and nervous system drugs (20,3%) were the main therapeutical classes. Approximately 70% of the DQD were classified as of intermediate risk. Drug suppliers replied 83.6% of notifications. No notification has been completely analyzed by the sanitary surveillance. Conclusions: Pharmacovigilance is an important tool to minimize potential harm to the patient, since it prevents inappropriate medications from being made available for dispensing. DQD management also helps to minimize financial losses. The strengthening of this activity in all healthcare services also contributes to regulatory actions at the national level. Carolina Resende BitencourtCristiane Aparecida Menezes De PáduaPaula Lana De Miranda DrummondEdson PeriniSociedade 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 9, Iss 4 (2019)
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 Carolina Resende Bitencourt Cristiane Aparecida Menezes De Pádua Paula Lana De Miranda Drummond Edson Perini Pharmacovigilance of quality deviations in the public healthcare system
description	Drug quality deviation (DQD) is the disagreement with the parameters at the registration with after commercialization step. Pharmacovigilance programs should be notified of DQD to ensure drug efficacy and support patient safety. Objective: To describe DQD from public healthcare system and its impact on the pharmaceutical service. Methods: Descriptive analysis of DQD recorded at Belo Horizonte primary and secondary care facilities, from April to September 2016. Variables: Type of DQD, pharmaceutical product, therapeutic class, notifying health unit, risk classification, and reply of DQD notification. This analysis was described by measures of central tendency and dispersion. Results: 329 DQD in 271 notifications were recorded leading to a loss of 9,311 preparations, representing on average 0.2% of the purchased lot. Most DQD were recorded at the primary health care level in solid preparations. Drug-related problems included deviations in package content (47%), package integrity (26%), label (5%), and pharmaceutical product itself (22%). Anti-infectives for systemic use (21%) and nervous system drugs (20,3%) were the main therapeutical classes. Approximately 70% of the DQD were classified as of intermediate risk. Drug suppliers replied 83.6% of notifications. No notification has been completely analyzed by the sanitary surveillance. Conclusions: Pharmacovigilance is an important tool to minimize potential harm to the patient, since it prevents inappropriate medications from being made available for dispensing. DQD management also helps to minimize financial losses. The strengthening of this activity in all healthcare services also contributes to regulatory actions at the national level.
format	article
author	Carolina Resende Bitencourt Cristiane Aparecida Menezes De Pádua Paula Lana De Miranda Drummond Edson Perini
author_facet	Carolina Resende Bitencourt Cristiane Aparecida Menezes De Pádua Paula Lana De Miranda Drummond Edson Perini
author_sort	Carolina Resende Bitencourt
title	Pharmacovigilance of quality deviations in the public healthcare system
title_short	Pharmacovigilance of quality deviations in the public healthcare system
title_full	Pharmacovigilance of quality deviations in the public healthcare system
title_fullStr	Pharmacovigilance of quality deviations in the public healthcare system
title_full_unstemmed	Pharmacovigilance of quality deviations in the public healthcare system
title_sort	pharmacovigilance of quality deviations in the public healthcare system
publisher	Sociedade Brasileira de Farmácia Hospitalar e Serviços de Saúde
publishDate	2019
url	https://doaj.org/article/b5da99e20a1c4a8a97b339708dbc50ab
work_keys_str_mv	AT carolinaresendebitencourt pharmacovigilanceofqualitydeviationsinthepublichealthcaresystem AT cristianeaparecidamenezesdepadua pharmacovigilanceofqualitydeviationsinthepublichealthcaresystem AT paulalanademirandadrummond pharmacovigilanceofqualitydeviationsinthepublichealthcaresystem AT edsonperini pharmacovigilanceofqualitydeviationsinthepublichealthcaresystem
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Pharmacovigilance of quality deviations in the public healthcare system

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