Health Councils and Pharmaceutical Policy: Challenges and prospects for social participation in Brazil

Manzini, Fernanda; Chaves, Luisa Arueira; Boff, Vinícius André; Sá, Dalmare Anderson Bezerra de Oliveira Falcão e; Lima, Maria Eufrásia de Oliveira; Leite, Silvana Nair

doi:10.1590/1413-81232026311.14132025

person Fernanda Manzini

study conception and design · data analysis and interpretation · manuscript writing · approval of the final version of the manuscript

schoolPrograma de Pós-Graduação em Assistência Farmacêutica, Universidade Federal de Santa Catarina. R. Delfino Conti s/n, Trindade. 88040-370 Florianópolis SC Brasil. manzinifer@gmail.com

0000-0002-3047-4632

person Luisa Arueira Chaves

data analysis and interpretation · manuscript writing · approval of the final version of the manuscript

schoolCentro Multidisciplinar UFRJ-Macaé, Universidade Federal do Rio de Janeiro. Macaé RJ Brasil.

0000-0002-9597-3651

person Vinícius André Boff

Data analysis and interpretation · manuscript writing · approval of the final version of the manuscript

schoolPrograma de Pós-Graduação em Assistência Farmacêutica, Universidade Federal de Santa Catarina. R. Delfino Conti s/n, Trindade. 88040-370 Florianópolis SC Brasil. manzinifer@gmail.com

0000-0002-0145-2629

person Dalmare Anderson Bezerra de Oliveira Falcão e Sá

study conception and design · data collection · manuscript writing · approval of the final version of the manuscript

schoolPrograma de Pós-Graduação Profissional em Saúde Pública, Instituto Aggeu Magalhães Fiocruz Pernambuco. Recife PE Brasil.

0009-0001-5212-9215

person Maria Eufrásia de Oliveira Lima

study conception and design · data collection · data analysis and interpretation · manuscript writing · approval of the final version of the manuscript

schoolMestrado Profissional em Políticas Públicas em Saúde, Escola de Governo Fiocruz-Brasília. Brasília DF Brasil.

0000-0002-0846-8156

person Silvana Nair Leite

study conception and design · data interpretation · approval of the final version of the manuscript

schoolPrograma de Pós-Graduação em Assistência Farmacêutica, Universidade Federal de Santa Catarina. R. Delfino Conti s/n, Trindade. 88040-370 Florianópolis SC Brasil. manzinifer@gmail.com

0000-0002-5258-9684

Chief editors:

Maria Cecília de Souza Minayo, Romeu Gomes, Antônio Augusto Moura da Silva, Vania de Matos Fonseca

Analytical category	What the categories address	Nº of excerpts
Access to medicines and supplies in the SUS	They address important issues regarding the judicialization, standardization, and distribution of medicines and supplies. Discussions focus on the impact of the high cost of lawsuits, the time required for medicine registration, shortages, and the lack of cancer treatments, as well as care strategies for chronic diseases and progress in access to medicines for people with HIV/AIDS. They also discuss the benefits of decentralizing medicine distribution and the challenges related to accessibility in pharmacies and the management of medicines for rare and chronic diseases, with suggestions for improvements in pharmaceutical services.	29
Acquisition and shortage of medicines and supplies	They highlight recurring problems of medicine shortages in units managed by health secretariats and in outsourced services. Council members discussed issues such as the lack of pharmaceutical professionals and the challenges of acquiring medicines due to problems with suppliers and bidding processes. There are some clarifications from management regarding acquisition processes, interstate consortia, and efforts to normalize supply. Actions were suggested to improve transparency, the structure of pharmacies, and the creation of commissions to address pharmaceutical services issues more frequently.	34
Pharmaceutical Services Committee or Working Group	They address discussions about the importance of creating or strengthening committees to deal with the complexities of pharmaceutical services, including medicine shortages and litigation. Some councils recognize the importance of creating the committee, but highlight challenges related to the excessive number of committees within the councils and quorum problems at meetings.	6
Financing and management tools of the SUS	They address issues such as reading and approving proposals from state and national conferences, presenting and analyzing the Previous Quarterly Detailed Report (RDQA), the Annual Management Report (RAG), the Multi-Year Plan (PPA), and the Annual Budget Law (LOA). The approval of funds transferred by a state secretariat to municipalities to structure pharmaceutical services is highlighted, as is the concern regarding the oversight of the use of these resources. The council members discuss the creation of committees and working groups to improve the management and execution of established goals. They reveal some mentions of the implementation of indicators and targets, the financing of pharmaceutical services, and a deficit in the payment of the state counterpart, reflecting a historical underfunding.	33
Organization of services and access to medicines and supplies during the COVID-19 pandemic	The discussions focus on conducting rapid COVID-19 tests in pharmacies, managing essential medications and supplies such as sedatives for intubation, the logistics and distribution of vaccines, and training pharmacy professionals. There are also mentions of difficulties in acquiring and distributing medications, including questions about the use of medications without proven efficacy in treatment, such as chloroquine and hydroxychloroquine. Finally, concerns about the transparency of stocks and the management of hospital supplies are highlighted, as well as criticisms of the pandemic response by municipal and state authorities.	45
Health services management	Several issues relate to the administration and management of health units and contracts, including the outsourcing of services and the role of social organizations. There is concern about the lack of transparency in contracts and their impacts, such as problems with medication logistics and the closure of specialized services, directly affecting access to medicines. The actions of social organizations are questioned regarding the purchase of medicines without bidding.	12
Pharmaceutical services	Discussions focus on the role of pharmacists in the SUS, highlighting the reduced number of these professionals in PHC units and hospitals, and concerns about the impact of this shortage on access to medicines and comprehensive care for users, especially in areas such as mental health and chronic diseases. The outsourcing of pharmaceutical services and the management of these units are also central themes, raising concerns about the safety and quality of medicine dispensing. The discussion includes advancements in the PP management services over the years, the expansion of access to medications from the Specialized Component, and the implementation of pharmaceutical care projects.	19
Integrative and Complementary Practices (ICPs)	They primarily highlight the development and implementation of Living Pharmacy Projects, focusing on the production of medicinal plants and herbal remedies. There are concerns about problems in the execution of resources allocated to the projects, the difficulty in acquiring supplies, and the sustainability of the projects. The advisors emphasized the importance of Integrative and Complementary Health Practices (ICPs) as a way to value traditional knowledge.	8

Analytical category	Examples of excerpts from state/district councils (CE) or municipal councils (CM)
Access to medicines and supplies in the SUS	Regarding women experiencing homelessness [...] for the subdermal implant, Service X is the one that has the project. However, she points out that the amount is small. Together with the Ministry of Health, she reinforces that they have tried several times to include both Implanon and the Mirena IUD, and they can't - CONITEC always blocks it, not including these methods, which is one of the things she considers fundamental to be in the range of reproductive planning options (CE16). There is a lawsuit asking for the trade name of a medicine, when we are prohibited from bidding with the trade name. [...] She believes that there is a deviation from the judicialization process when a person takes this route to guarantee a right that is not for everyone, but only for her. A right is valid when it is for everyone. When a trick is used so that it only serves me, a problem is created (CE6).
Acquisition and shortage of medicines and supplies	Councilor U2 says she is happy with the presentation [made by management], but has in hand a list of the 28 medicines that are missing. She understands that there is a whole process, but the medicine that has been missing for two or three months, elderly users travel a distance to get there, and have to return. This communication is not happening, and the user is having to buy the medicine (CE11). [...] He adds that last Friday, he and the State Secretary of Health were at the first meeting of the Northeastern Consortium of State Health Secretaries, and that the proposals are quite interesting - to standardize some procedures, such as the issue of acquiring medicines and necessary supplies, expanding the potential for acquisition to obtain better prices and advantageous purchases (CE16).
Pharmaceutical Services Committee or Working Group	Councilor U1 calls on the Council to reactivate the Pharmaceutical Services Committee [...], and says that these situations may be the result of some irresponsibility on the subject, recalling that the committee ceased to exist in 2010. Councilor P1 puts the proposal to reactivate the Pharmaceutical Services Committee to a vote, which is approved with only one abstention (CE20). Councilor P5 recommends that the Municipal Council prioritize Pharmaceutical Services more frequently, with a committee solely to address this demand. He concludes by saying that the lack of medicines is a Public Health issue and, as such, should be addressed. Social Participation is responsible for this process (CM16).
Financing and management tools of the SUS	Councilor G3 says, "I can speak authoritatively about the rural region. However, I can say the following: the process of debt credits for Pharmaceutical Services in the capital and the rural region was handled in different processes [...]. So even though it is less time, the municipalities had already been 4 years without receiving the Pharmaceutical Services' funds from the State. Now, in the last CIB, we approved and are transferring two years at once of these delayed funds [...] (CE4). In Guideline VIII - Qualification of pharmaceutical services, management of the logistics of acquisition, storage, and distribution of health supplies, Councilor P2 said that the mandatory demands and supply of the units served, the medicines for linked programs, and specific, acute, or chronic conditions served. The number of users served in the specialized component of pharmaceutical services left something to be desired when the low financial investments for this guideline were seen (CE2).
Organization of services and access to medicines and supplies during the COVID-19 pandemic	Councilor P1 mentions that in May, shortages of anesthetic and sedative medicines, necessary for intubating patients, began to emerge. [...] Councilor P3 also asks that the government respect science, as it is disrespectful for the federal government to insist on medicines that have not been proven to combat COVID-19 (CE20). People were asked to wait or return a few hours later to pick up some medicines [...] Azithromycin was out of stock at the UPA for a few hours, but this is not a lack of medicines in the city; it was a logistical issue due to increased demand. The demand for this medicine was reviewed, as its use was considered unnecessary for what was being prescribed [for early treatment of COVID-19] (CE11).
Health services management	We know that some Social Organizations (OSS) in our municipality have been receiving money for some time to manage municipal Public Health [...]. The big problem with OSS is that they run rampant, they do what they want, because most managers, when they hire an OSS, are outsourcing the problem because they have difficulty managing people, managing the purchase of supplies, equipment, medicines, and the like, which should follow the rules of the legislation [bidding, public competition] (CM6). [...] He suggested that the conditions under which the operator has to perform the service should be analyzed before implementation. He used as an example a case of the warehouse, in which the medicines spoiled due to the lack of a cold storage chamber (CM23).
Pharmaceutical services	[...] At the time of the visit, we did not have the physical structure and sufficient pharmacists, so we decided that the implementation of the Project would begin at the Pharmacy School of University X, which has an agreement with the SES for the provision of the Specialized Component of Pharmaceutical Services (CE11). [...] Regarding Pharmaceutical Services and Mental Health, some planned actions involve expanding pharmacies, increasing the number of pharmacists, and other management aspects [...] (CM23).
Integrative and Complementary Practices (ICPs)	Councilor P4 reports that the Call for Proposals for the implementation of living pharmacies is open at the Ministry of Health and that this call for proposals occurs annually. In 2013, the Municipal Health Secretariat submitted a project that was approved but has not yet yielded results, and one of the requirements to participate in subsequent calls for proposals is that the project has had results [...]. It also questions why these resources are not being used; consequently, phytotherapy is not progressing in the municipality (CM14). The Local Productive Arrangement Project, known as Living Pharmacy, which produces phytotherapeutic plants, which are medicines made from medicinal plants, is accompanied by manipulation, production, and dispensing. It is an instrument of the SUS of the municipality, and consequently, the sale will be prohibited, as the Health network itself produces it. He also says that it is a project that has been in place since 2014, where there were many difficulties in moving forward, because the inputs are very uncommon, which hinders procurement (CM16).

[TFN3n] Source: Authors.