Abstract
ABSTRACTOBJECTIVE To characterize the technical issues and conditions of medicines conservation in Primary Health Care of Brazilian regions, responsible for pharmacy/dispensing unit profile; environmental, storage, and dose fractioning conditions; inventory control and waste management; fire and electrical failure safety items; transportation problems; advertising regulation; and pharmacovigilance.METHODS This article is part of the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos – Serviços (National Survey on Access, Use and Promotion of Rational Use of Medicines – Services)–, a cross-sectional and exploratory study, of evaluative nature, consisting of an information survey within a representative sample of municipalities, stratified by Brazilian regions, which constitute the study domains, and a sample of Primary Health Care services. Pharmaceutical services (PS) were directly observed with photographic record and face-to-face interviews with those responsible for the dispensing of medicines and over the telephone with those responsible for pharmaceutical services. Data were processed with the SPSS® software version 21.RESULTS The investigated dimensions showed relevant deficiencies and inequalities between the regions, generally more favorable in the Southeast and Midwest regions and weaker in the Northeast and North regions. We verified non-compliance with technical requirements and conditions essential to the conservation of medicines, which may interfere with the maintenance of stability and, thus, on their quality, efficacy, and safety. The regulation of advertising/promotion of medicines is still incipient and there is some progress in the structuring of mechanisms regarding pharmacovigilance.CONCLUSIONS The sanitary situation of medicines in Brazilian Primary Health Care is alarming due to the violation of the specific sanitary legislation for dispensing establishments and due to a wide range of requirements essential to the conservation of medicines. We observed a disconnection between the efforts made in the Brazilian Unified Health System to promote access to medicines for all population and the organization and qualification of pharmaceutical services.
Highlights
Medicines have a hybrid nature, present benefits, and health risks; they are health care inputs and, at the same time, a commodity on the market that requires, sanitary regulation in all stages of their production cycle
We observed a disconnection between the efforts made in the Brazilian Unified Health System to promote access to medicines for all population and the organization and qualification of pharmaceutical services
This article is part of the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos – Serviços, 2015 (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines – Services, 2015), which aimed to characterize the organization of pharmaceutical services in the Primary Health Care of SUS, aiming at the access and promotion of rational use of medicines, as well as to identify and discuss factors that interfere in the consolidation of pharmaceutical services in the cities
Summary
Medicines have a hybrid nature, present benefits, and health risks; they are health care inputs and, at the same time, a commodity on the market that requires, sanitary regulation in all stages of their production cycle. The State is responsible for regulating the production, trade, transport, storage, dispensing, and use of medicines so they can achieve their purpose in the health system[6]. The history of medicines in Public Health has been marked by successes and tragedies, which encouraged national states to implement strong regulatory systems, in legislation and institutional structures, as well as the formulation and implementation of concepts that mean safety assurance measures before the medicine is delivered to consumption[15]. The regulatory systems must act to protect the population’s health from ineffective and unnecessary medicines and promote the rational use, in addition to intervene in market strategies that aim to stimulate the consumption of medicines[5] as common consumer goods. The information reports from the analysis and approval of reports and package inserts of the product to the advertising and promotion of the medicine[27]
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