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[Review of national and international legal and regulatory mechanisms on the management of drugs and the residues thereof].

Authors :
Oliveira NR
Lacerda PSB
Kligerman DC
Oliveira JLDM
Source :
Ciencia & saude coletiva [Cien Saude Colet] 2019 Aug 05; Vol. 24 (8), pp. 2939-2950. Date of Electronic Publication: 2019 Aug 05.
Publication Year :
2019

Abstract

This paper presents a descriptive review of laws and regulations on the management of drugs and the residues thereof adopted by countries in Europe, the Americas and Australia. This review integrates relevant points of official documents of regulatory agencies in these countries, as well as important scientific works. All countries surveyed carry out drug management concomitant with the management of the residues thereof, ranging from awareness programs on the rational use and the risks of drugs through to the collection and safe disposal of such residues. Germany, the USA and Sweden demand a prior assessment of the environmental impact caused by a given drug as a criterion for its registration. Sweden is noteworthy in that it periodically updates a list of essential drugs based on risk assessment and the environmental risks posed by the residues thereof. In Brazil, the legal measures proposed including rational prescription and reverse logistics have not yet been effectively implemented. Prior environmental impact assessment safeguards the risks to human health and the wild biota caused by exposure to drug residues. Therefore, these international models could serve as a basis for discussion and/or legal and regulatory changes in Brazil.

Details

Language :
Portuguese
ISSN :
1678-4561
Volume :
24
Issue :
8
Database :
MEDLINE
Journal :
Ciencia & saude coletiva
Publication Type :
Academic Journal
Accession number :
31389541
Full Text :
https://doi.org/10.1590/1413-81232018248.05712017