Abstract
Pharmaceutical Services (PS) is a growing field which has established itself over the last 25 years in Brazil through scientific publications. This work investigates the evolution of the field in the Brazilian periodical Journal Ciência & Saúde Coletiva. We conducted a scoping review of relevant literature produced in four separate periods (1996-2003, 2004-2010, 2011-2015, and 2016-2019). A search for articles that contained one or more of the pre-established key words in the title was performed by separate pairs of reviewers. The search resulted in 307 articles, 260 of which were included. The findings show that the number of publications increased steadily over the study period. The papers were predominantly open-topic and original articles and written in Portuguese. Most of the lead authors were from the South and Southeastern regions of Brazil and from public universities and Fiocruz. The predominant primary theme was medicine utilization (161 articles), followed by management (56), and tangential aspects of the PM cycle (43). An ontology of PS was created based on the classification of the articles. The findings show that the field of PS encompasses public policy and management and frontline activities involved in the delivery of health care to the population. It is hoped that the diverse range of interrelations in the field of PS will be increasingly addressed in future publications.
Key words: Pharmaceutical Services; Publications; Review
Resumo
A Assistência Farmacêutica (AF) é um campo em expansão no Brasil e nos últimos 25 anos vem se consolidando também através da publicação científica. O objetivo deste trabalho foi investigar a evolução da AF como campo na Revista Ciência & Saúde Coletiva. Uma revisão de escopo, em quatro períodos, 1996-2003, 2004-2010, 2011-2015, 2016-2019, foi realizada por duplas de pesquisadores, buscando palavras e termos de busca nos títulos. As inclusões foram totalizadas por ano de publicação, suas características descritas quanto ao tipo de artigo, idioma, local e instituição de origem do primeiro autor e classificadas por temáticas principais, secundárias e especificidades. Foram resgatados 307 artigos e incluídos 260. Os resultados refletiram aumento de publicações ao longo do tempo, participação majoritária de artigos de tema livre e originais, em português, de autores das regiões Sul e Sudeste, de universidades públicas e da Fiocruz. Os temas principais foram Utilização de Medicamentos (161 artigos), Gestão (56) e Temas Tangenciais ao Ciclo da AF (43). A partir da classificação foi elaborada uma ontologia própria da AF. O campo reúne política pública a atividades gerenciais e de cuidados em saúde à população. Espera-se que essa variada gama de interrelações venha a se expressar cada vez mais na publicação científica.
Palavras-chave: Assistência Farmacêutica; Publicações; Revisão
Introduction
Pharmaceutical Services (PS) is a relatively recent field within the pharmaceutical sciences, which has traditionally been shaped by the so-called basic sciences, such as physics, chemistry, biochemistry, and physiology. In turn, the basic sciences characterized the way in which pharmacy was taught and, consequently, the profile of professionals working in academia and care services. Over recent decades, social issues linked to medication have gained greater importance, given that the natural sciences on their own are not capable of explaining or delving deep into aspects that involve relationships between medication and individuals, families, communities, or indeed professional practice1,2.
Brazil’s Organic Health Law, which regulates public health services and actions, provides that one of the fields of action of the country’s public health care system, o Sistema Único de Saúde (SUS) or Unified Health System, is the formulation of the national medicines policy, and states that the health sector shall be responsible for executing comprehensive therapeutic care actions, including pharmaceutical services3. However, PS in Brazil only came to gain a clearer delineation with the introduction of the National Medicines Policy (NMP) in 19984. With regard to the public management of medicines, in 1999 the government embarked on a process to decentralize PS5, defining the responsibilities of each level of management as follows: federal - policy formulation and implementation; state - policy coordination, implementation, monitoring, and evaluation; and local - service provision3.
Another milestone was the creation of the National Pharmaceutical Services Policy (PNPS, acronym in Portuguese) in 2004, which states that the professional activities of pharmacy professionals in the field of PS include health promotion, protection, and recuperation. It also provides guidelines for the development of PS in terms of innovation and the production of medicines and supplies, promoting the inclusion of PS in the 2004 National Agenda of Priorities for Health Research6.
With the incorporation of PS into the framework of the NMP, an organizational model called the pharmaceutical management cycle (PM cycle) was adopted. Developed in the middle of the 1990s by Management Sciences for Health7, this milestone has been revisited over time to reflect changes in the field that have an impact on the organization of PS activities8. Three core activities are particularly relevant to the PM cycle: tangential activities that precede the cycle, involving actors outside the field of PS; management; and activities related to medicine utilization9.
It is to be expected that scientific output reflects political, normative, and technical frameworks, not only in key moments in the development of the field, but also in relation to the technical maturation of the area and involvement of professionals. An integral part of public health, PS is in its essence the articulation of knowledge tied to practices in health services. Although it encompasses various disciplines from the pharmaceutical sciences, the field is strongly influenced by the social sciences10. The literature has highlighted important changes in PS over time, reflecting on core themes and the role of PS in the SUS11.
Assuming that major public health issues are present in the discussion of this field and its evolution in Brazil, this article analyzes the literature on PS published in the pages of the Journal Ciência & Saúde Coletiva (C&SC) and proposes a first-of-its-kind ontology of PS in Brazil.
Methods
We conducted a scoping review of PS in the C&SC12,13. The review period (1996 to 2019) was divided into four time blocks circumscribed by important policies in the area of PS4-6,14-20 and volume of publications, as follows: 1996-2003, 2004-2010, 2011-2015, and 2016-2019.
A pair of researchers were responsible for conducting the search for relevant articles in each time block. The identification of articles was initially carried out independently by each pair member and then in consensus between the pairs and review team to clear up any doubts and detect inconsistencies.
A search was conducted of each issue of the Journal on the C&SC’s website, selecting articles that contained one or more of the following keywords in the title: assistência farmacêutica (pharmaceutical services), medicamentos (medicines), política de medicamentos (medicines policy), farmacêuticos (pharmaceuticals), setor farmacêutico (pharmaceuticals sector), indústria farmacêutica (pharmaceuticals industry), and farmácia hospitalar (hospital pharmacy). The full-text versions of the identified articles were then downloaded using the SciELO link on C&SC’s website and the abstracts were read to check for the keywords mentioned above.
The selected articles were then assessed for eligibility by reading the full-text version. Articles that addressed themes not directly related to PS or medication therapy were excluded, resulting in the final sample of articles for review.
The following information was extracted from the articles: year of publication, author(s), lead author’s affiliation and place of origin, Digital Object Identifier (DOI), section of the publication, type of article, abstract, and keywords. The articles were organized sequentially in a database.
For the analysis, the articles were described in chronological order, presenting the article number, author(s), lead author’s affiliation and place of origin, language in which the paper was published, and type of article. For the purposes of thematic analysis, the articles were grouped according to primary themes, secondary themes, and specific topics based the conceptual framework for pharmaceutical services described in the literature8,9,21: primary theme (tangential aspects of the PM cycle, management, and medicine utilization), secondary theme (an aspect of the primary theme constituting an activity, normative guideline, or conceptual discussion), and specific topics (an underlying topic that reflects the object or locus of the investigation). The dependency relations between the primary themes, secondary themes, and specific topics were also highlighted, thus creating an ontology of PS in the pages of the C&SC.
Results
The search by title yielded 307 articles (Figure 1). The reading of the abstracts resulted in the exclusion of 47 papers addressing topics not directly related to PS: health policy, health spending, health resource allocation, health funding, health care, diagnostics, toxicology, medical practices, medicalization (not related to medication therapy), smoking, illicit drug use, non-medical contraceptive practices, medical and hospital supplies, non-drug therapies, quality of life, and nutrient supplementation. This stage resulted in a final sample of 260 articles (Chart 1).
Flow diagram of the selection of articles addressing themes in the field of Pharmaceutical Services (PS) published in the Journal Ciência & Saúde Coletiva between 1996 and 2019. C&SC, 2020.
The time horizon covered by the review extended from the first volume of the Journal (published in 1996) to the last volume of 2019. In 1996, none of the articles published in the Journal met the eligibility criteria. The number of publications in the field of PS has grown considerably over the last 24 years, particularly from 2008, as shown in Figure 2.
Number of articles addressing themes in the field of pharmaceutical services published in the Journal Ciência & Saúde Coletiva between 1996 and 2019. C&SC, 2020.
In April 2008, the Journal launched its first thematic issue on medicines, leading to an increase of 29 articles in comparison to the previous year. Since then, the annual number of publications has stood between 11 and 38.
Although the number of articles grew consistently, article characteristics varied considerably over the period (Figure 3).
Characteristics of articles addressing themes in the field of pharmaceutical services published in the Journal Ciência & Saúde Coletiva between 1996 and 2019 - (A) article type, (B) language, (C) type of institution of origin of the lead author, and (D) lead author’s place of origin. C&SC, 2020.
With regard to article type (A), most of the articles were open-topic, followed by original articles (which according to the Journal comprise empirical works). The latter were prominent mainly between 2004-2010 (37) and 2016-2019 (25). The total numbers of thematic articles do not coincide exactly with the publication of thematic issues on the field (2008 and 2017). The number of reviews was small and the number of articles in the other categories was relatively insignificant. The debate articles were published in the years in which the thematic issues were published.
The large majority of works were published in Portuguese (B). The number of articles written in English or both Portuguese and English was greater in the period 2016-2019. The type of institution of origin (C) that contributed most to the theme was public universities (141), across all years, followed by the Oswaldo Cruz Foundation (48) or Fiocruz (acronym in Portuguese). The annual number of articles produced by these types of institutions grew steadily throughout the period, while the number produced by private universities (35) and foreign institutions (10) fell. Brazil’s National Health Surveillance Agency, ANVISA, published articles in the periods 2004-2010 (6) and 2011-2015 (1).
The majority of the lead authors were from the Southeast Region, followed by the South, Northeast, Center-West, North regions, and outside Brazil. The annual number of articles from authors from the Southeast Region grew throughout the period, while the number produced by authors from the other regions remained stable. Authors from the North Region and outside Brazil made only a modest contribution to the theme over the study period, showing a decrease in publications in the last period (2016-2019), and promoting an increase in publications by these authors remains a challenge.
An initial analysis of the themes addressed by the articles was conducted based on the key words. The 260 selected articles contained 909 key words. Duplicate words were eliminated, resulting in 550 words, 406 of which (74%) appeared only once. The 10 most frequent key words were descriptors: assistência farmacêutica or pharmaceutical services (38), medicamento or medication (a synonym of the descriptor ‘preparações farmacêuticas’ or pharmaceutical preparations) (35), uso de medicamentos or medicine use (23), sistema único de saúde or unified health system (20), atenção primária em saúde or primary health care (18), farmacoepidemiologia or pharmacoepidemiology (17), vigilância sanitária or health surveillance (13), and idoso or the elderly (12).
Figure 4 shows the trends in the primary themes based on the conceptual framework for PS in Brazil described in the literature7-9.
Proportion of articles published in the Journal Ciência & Saúde Coletiva between 1996 and 2019 in the field of pharmaceutical services, by primary theme. C&SC, 2020.
Figure 5 shows the percentage distribution of the primary themes in the four time-blocks covered by this study. Medicine utilization was consistently the most frequent core theme throughout the period, with 161 articles, followed by management, with 56 articles, and tangential aspects of the PM cycle, addressed by 43 articles.
Secondary themes addressed by the articles published in the Journal Ciência & Saúde Coletiva between 1996 and 2019 in the field of pharmaceutical services, by primary theme - (A) Management, (B) Tangential aspects of the PS Cycle, and (C) Medicine Utilization. C&SC, 2020.
Secondary themes addressed by the articles published in the Journal Ciência & Saúde Coletiva between 1996 and 2019 in the field of pharmaceutical services, by primary theme - (A) Management, (B) Tangential aspects of the PS Cycle, and (C) Medicine Utilization. C&SC, 2020.
The range of secondary themes increased steadily over the period, as demonstrated by Figure 5, which shows the secondary themes under each primary theme.
Figure 5 shows that the scope of the publications became increasingly complex over the study period, with the introduction of multiple secondary themes. The primary theme that showed the widest range of secondary themes was medicine utilization (A), starting with a relatively lower number in the period 1996-2003, but increasing thereafter.
In the primary theme management (B), articles initially concentrated mainly on the secondary theme medicines policy, with the emergence of several new themes thereafter, such as public provision, public procurement, technology assessment, and PS services. The core theme tangential aspects of the PM cycle (C) encompassed secondary themes related to health regulation across all periods, with the themes global health, registration, technology assessment, and research and development emerging in the last period.
With the classification of the articles into primary themes, secondary themes, and specific topics, it was possible to build the ontology of PS in the pages of the C&SC set out in Chart 2.
The chart shows each primary theme together with the dependent secondary themes and specific topics and the frequency of each classification. Two characteristics in particular stand out in the box: first, the same secondary themes and specific topics are present across the different primary themes, depending on the approach of the study; second, secondary themes also appear as specific topics in cases where they are the object of study. With regard to specific topics, the findings show that the frequency of the generic topic ‘frameworks and concepts’ decreased over the period, while the frequency of ‘the elderly’, ‘psychotropic drugs’, and ‘primary health care’ increased, becoming prominent topics in the publications. The relatively large number of articles with the secondary theme knowledge about medicines (26 articles), pharmacoepidemiology (26), and medicalization and pharmaceuticalization (18), also warrants highlighting.
The primary themes showed the following number of secondary themes and specific topics, respectively: tangential aspects of the PM cycle, 10 and 21; management, 18 and 31; and medicine utilization, 24 and 50. The box also shows the interconnection between each primary theme and the secondary themes and specific topics, according to the number of related articles.
Discussion
The growth of the theme of PS in the pages of the C&SC in recent years is notable. The publication of a thematic issue on medicines in 2008 marked an inflection point for the theme, appearing to have aroused interest in the area among researchers.
A number of journals in the area of Pharmaceutical Sciences reflect biomedical research output - be it laboratory studies, research in the field of pharmacology, or clinical studies. The research output is accompanied by the fact that most post-graduate courses in pharmaceutical sciences are within the pharmacy framework rather than the public health frameworkk22,23.
However, the findings show a growth in studies describing the results of pharmaceutical services within the theme of drug utilization research (DUR), which reflects the discussions and changes in the field over recent years. The increase in the number of works is to be expected, mainly due to the publication of national curriculum guidelines for pharmacy degrees in 2002 and 2017. These guidelines reinforce that essential content for the training of pharmacy professionals should encompass the health-disease process, focusing on users, their family, and the community, and drawing on the human and social sciences24-26.
PS has gained more prominence in the published literature over the years, covering a range of topics, including the development of the SUS11,27, health issues and health spending28,29, the evolution of pharmacoepidemiology30,31, and the discussion of activities and procedures designed to meet the population’s health needs32,33. Despite the increasing presence of articles about PS in other national periodicals, journals in the field of public health like the C&SC remain focused more on the so-called “social” aspects of the pharmaceutical sciences. It is evident that the C&SC is an important vehicle for disseminating the theme, accounting for between 5 and 10% of the annual publication of articles on PS in Brazil over the last 11 years.
Internationally, there are a number of periodicals in the fields of pharmaceutical sciences and public health. As in Brazil, scientific output on the theme tends to be dichotomized between biomedical research and the social sciences. However, conceptual differences related to the term PS adopted in the descriptors used in and outside Brazil remain a challenge for the appropriation of the theme across countries and influences publications in the field of PS. Assistência Farmacêutica has been translated to English in a variety of ways. A first such translation was “pharmaceutical care”. However, the international literature emphasizes the element of care, which involves interaction between the pharmacy professional and the patient, contributing to improve quality of life34. The term pharmaceutical care therefore refers to Atenção Farmacêutica in Portuguese. On the other hand, a free translation of this assistência farmacêutica would be “pharmaceutical assistance”, which is completely inadequate as a descriptor, because it refers to pharmaceutical benefits.
The term pharmaceutical services35 emerged in the context of the Americas as part of the discussions about local health systems. Although this term has not achieved unanimity, because it can refer to specific point-of-care services36-38, it is important to highlight that the Latin American and Caribbean Center on Health Sciences Information, or BIREME, adopts the English and Spanish terms “pharmaceutical services” and “servicios farmacéuticos” for assistência farmacêutica39. Thus, although the terms are close, but not identical, a concerted effort should be made to align terms towards a common, official synonym. Ensuring the use of the same descriptors is a strategy that seeks to consolidate the field and promote commonality throughout scientific publications. In the pages of the C&SC, this effort seems to be working, with poor translations of the term PS being witnessed only on rare occasions, especially after 2010.
Open-topic articles, and more recently original articles, make up a significant proportion of published articles, reflecting the adoption of this practice in health facilities and management practices. There are still relatively few reviews in the field of PS, be they systematic, narrative, scoping, or qualitative. This may be because the growth in research in this area is only recent and there is therefore an unmet need to bring together enough references on the same topic to ensure a robust review40-44.
An increasing number of articles are submitted for publication in English. The strategy adopted by the C&SC and other journals to translate articles and accept papers written in English and Spanish, based on a requirement established by SciELO, has helped not only to disseminate knowledge but also place authors in a better position for dialogue with international peers and partners. The topics brought by the articles on PS, such as pharmacoepidemiology, resource allocation, and technology assessment, are increasingly finding shared identity outside Brazil. In addition, the study of the advances made by the SUS - right to health and universal access to health care - reinforces the importance of studying system disparities brought about by context and disruption phenomena, which generate inequalities - leading for example to health-related litigation to gain access to medicines - and draw interest from the international community45-48.
The lead authors were predominantly from academic institutions such as universities and FIOCRUZ, showing that the theme is being disseminated and producing knowledge. However, it is public universities that dominate PS research output. Foreign institutions and authors made only a small contribution to publications over the period.
The findings show that output remains concentrated in the Southeast, the country’s leading region for scientific output. This reflects so many other “concentrations” in the Southeast, including research groups, research funding, and decision-making power in the allocation resources to health and PS49.
The predominant primary theme across all periods was medicine utilization. Medicine utilization involves questions often related to the characteristics of medicines, professionals - prescribers, dispensers - and patients. Its development is therefore largely driven by the need to understand the positive and negative consequences of medicine utilization, its relationship with health regulations, and the real obligation to provide inputs to support the adequate management of these supplies.
The first period (1996-2003) coincides with the beginnings of PS in the recently created SUS and the publication of the NMP. It is no coincidence therefore that open-topic articles addressing theoretical frameworks and concepts were the most frequent. The history of the normative framework that delineates PS in Brazil is recent. Despite the introduction of the NMP in 1998, the infra-legal rules that govern PS only emerged later. The drug fraud crisis of 1998 led to a focus on health surveillance and medicine regulation. The system, faced with the challenge of restructuring itself, focused on quality assurance for supplies and products, forcing the reshaping of public and private pharmaceutical services to ensure the guarantee of origin of products provided to the public50. This led to the emergence of themes related to regulation in the pages of the C&SC.
Another important moment was the launch of the Pacto pela Saúde or “Health Pact” in 200651,52. The Pact introduced a package of institutional reforms for the SUS, with a series of innovations in management processes and instruments, including the funding of PS. This gave rise to the appropriation of the new rules and their “impacts” on the population and system by both managers and academics.
In the second period (2004-2010), the country witnessed the expansion of the SUS and establishment of PS programs and original articles became more prominent. In this regard, studies addressing topics related to the components of PS funding, medicine access programs like the Farmácia Popular, and judicialization only began to be published after the limits and possibilities of PS and the SUS were delineated. Although medicine utilization remained the dominant theme throughout, management gained in relative importance over the period, reflecting professional practice in the organization of the SUS53-57. During the third period (2011-2015), PS experienced the turbulence generated by the conceptual modification of RENAME, the country’s essential medicines list, reducing it from a set of low, medium, and high complexity medicines to meet health needs to a mishmash of funding lists of on-demand medicines55.
With regard to the primary theme tangential aspects of the PM cycle, the number of publications addressing themes that shaped the field of PS at the beginning, such as health regulation, intellectual property, and the struggle for access to antiretroviral medicines, decreased proportionately over the period with the emergence of new themes like global health and international cooperation58,59. It is interesting to note that the number of studies addressing this primary theme increased in the last period (2016-2019), suggesting that it is the more innovative and global themes in the field of PS that will be more discussed and explored in coming years.
The ontology60 produced by this study reveals the wide diversity of themes related to the field of PS in the pages of the C&SC, bringing together a variety of recurring secondary themes, together with new topics (such as global health and international cooperation), others that have taken on greater prominence (such as pharmacoepidemiology, pharmacoeconomics, health technology assessment, and pharmaceuticalization and medicalization), and emerging themes like health emergencies and disasters. Our findings show that there are numerous specific topics that cut across the primary and secondary themes. It is this variety and range of perspectives that promotes the dissemination of various points of view on the same topic, bringing development and conceptual solidity and pointing to new pathways for analysis and new knowledge. The ontology shows that the field is not static, but rather dynamic, and, more importantly, integrated, demonstrating its utility for the investigation of relations of interdependency between themes and for future articles on the theme of PS.
This study has some limitations. Although article identification was conducted by the entire review team and special care was taken to ensure a systematic selection process and clear up doubts regarding article eligibility, there were differences of opinion regarding the inclusion of articles. However, the joint review of the articles by the review team meant that it was possible to resolve these differences. Another challenge was the classification of articles according to primary themes, secondary themes, and specific topics. Differing views on the themes and their interdependencies meant that the classification relied on objective judgment, which may have resulted in reductionist decisions regarding themes. Nevertheless, we believe that the ontology depicts the diversity of the field.
Finally, the descriptors used for an initial search of the SciELO website did not provide a reliable search, resulting is a series of information gaps. The search was only successful when it was repeated and validated by checking C&SC’s site. This shows the utility and reliability of C&SC’s site as a tool for future reviews using the Journal.
Conclusions
Our findings reveal the sustained growth and dynamism of the field of PS in the pages of the C&SC over the last 24 years, becoming one of the Journal’s core themes today. Although the Journal includes studies from all regions of Brazil, efforts should be made to increase the contribution of authors from the North, Northwest, and Center-West regions and authors outside Brazil. The types of institutions that contributed most to the expansion of the field were public universities, followed by Fiocruz.
The articles were classified into core primary themes (medicine utilization, management, and tangential aspects of the PM cycle), complemented by secondary themes and specific topics, illustrating the diversity of and interrelation between themes.
Different phenomena that had an impact on public health over the study period were present to a greater or lesser extent. As we have seen, PS has reflected the emerging knowledge in the field of medicines and medication therapy. It was PS that brought the theme of judicialization to the fore; It was PS that brought the discussion of themes like access to medicines and intellectual property. New and challenging studies on the theme directed at the C&SC are awaited.
PS is an expanding field that encompasses the complexity of public policy combined with management and frontline activities involved in the delivery of health care to the population. The field produces a diverse range of interrelations and it is hoped that these interrelations will be increasingly addressed by future publications.
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Publication Dates
-
Publication in this collection
04 Dec 2020 -
Date of issue
Dec 2020
History
-
Received
15 Apr 2020 -
Accepted
08 June 2020 -
Published
10 June 2020