A Sociotechnical Approach to Analyse Pharmaceutical Policy And Services In Primary Health Care

Background: Access to medicines and its rational use are persistent global concerns. It have a major impact on the quality and sustainability of the health system and on the health outcomes. In Brazil, access to medicines is a legal right and municipal government have the duty to ensure access and the best use of medicines in primary health care public facilities, stablishing the local Pharmaceutical Policy and Services (PPS) system. This article presents and analyses an innovative experience of diagnosis of municipal PPS as a sociotechnical system, aiming to prepare the interventions in the system. Methods:We adopted a multi-methods approach and various data sources were used. Sociotechnical theory was the framework of the methodology of evaluation and design of systems, analysing the Components of External System (health system, stakeholders, nancing) and Components of the Internal System (Goals, Management, Workforce, Infrastructure, Processes, Technology and Culture). Results:The component “aim” was identied as the central element of the system. The other system components interrelate with its scope. Medicines availability was a key part of the PPS architecture. Lack of central coordination, pharmaceutical services without central management and a fragmented organization prevented an integrated internal planning, and with other sectors. The stakeholders and documents referred only technical elements of the system: infrastructure, technical process and technology. The social components of workforce and culture were not mentioned in the Municipal Health Plan. People are essential socio-technical elements, as well the components affecting them, but they are not privileged in the system. The organizational culture established was the culture of isolation: “each one does his own”. Conclusions:The municipal PPS emphasized medicines and technical components and had limited scope as a public policy. It had constrained the characteristics of a complex and open system. Stakeholders understood PPS as a set of technical processes, without planning or integration. PPS has had a great development in Brazil in the last twenty years. A new level of development to ensure the populations right to access of treatment requires a turning point of strategy to understand municipal PPS as a sociotechnical system. The present study was performed during the situational diagnosis of PPS, which was part of implementing the pharmaceutical eld in an interprofessional collaboration residency course in PHC for04 municipalities in the state of Santa Catarina/Brazil. Its reports an in-service experience with the development of a socio-technical assessment designed to promote the reorientation of PPS in PHC at the municipal level. The results of the diagnostic are presented about one of the municipalities participating in the project, where the study was conducted in partnership with the Municipal Health Secretariat (MHS).

The present study was performed during the situational diagnosis of PPS, which was part of implementing the pharmaceutical eld in an interprofessional collaboration residency course in PHC for04 municipalities in the state of Santa Catarina/Brazil. Its reports an in-service experience with the development of a socio-technical assessment designed to promote the reorientation of PPS in PHC at the municipal level. The results of the diagnostic are presented about one of the municipalities participating in the project, where the study was conducted in partnership with the Municipal Health Secretariat (MHS).

The place of study
The municipality studied located in the European Valley, in Santa Catarina, has an estimated population is 135 thousand inhabitants, the Human Development Index (HDI) is approximately 0.8 and the predominant economic activities are industry, agriculture and services [22].

Data collection
Various data sources were used to cover the scope of the interpretation in a sociotechnical analysis. The collection was related to data from the municipal  Table 1. Municipal sustainable development index (IDMS), health situation analysis [23].
Municipal Transparency Portal https://brusque.atende.net/?pg=transparencia#!/ Expenses with pharmaceutical policy and services [24]. 1  The collected data were related to: Municipal health system: infrastructure, organizational structure, Family Health Strategy coverage, workforce description of the Family Health Support Center, health funding and nancial circumstances; PPS: goals, organizational structure, available workforce and infrastructure, processes and organizational culture.
An institutional documentary published on the proposal for reorienting PPS in the municipality provided testimonies from managers, pharmacists, coordinators of health units, doctors and patients of municipal health services (available at https://www.youtube. com / watch? v = MqtG8mI8Srw).Another data were collected from articles on issues related to the PPS in newspapers published in the city between January 2016 and February 2017, radio stations and blogs that carry news about the municipality. Search strategy combined the terms "medicine" and "pharmaceutical policy and services".

b) Assessment Matrix of the Management Capacity of municipal PPS
We collected the data with the instruments from Assessment Matrix of the Management Capacity (AMMC) of the municipal PPS. Manzini and Mendes [9] developed and rst used AMM Cof the PPS in Santa Catarina municipalitiesvalidated the instruments. The matrix framework uses Carlos Matus' management assumptions, rst adopted by Barreto and Guimarães [25].
The collection was performed at the pharmacies located on municipal health department.

Data analysis
The documentsevaluation was performed by content analysis. The nancial and rates data were used as original data.The social and technical components of the municipal PPS system were typi ed according to the socio-technical structure described in Fig. 1.
The results were analyzed based on the sociotechnical dimensions, on the researchers' experiences and were typi ed according to the components described in Table 2. Annual nancing of PPS. Budgeted amount and amount paid.

Regulations
Rules and laws that regulate the organization Rules and municipal laws that regulate the organization and activities of PPS.

Components of the Internal System
Goals Targets of the system, its operation or that generated the demand for its construction.
Objective of municipal PPS for the different healthcare actors.

Management
Organizational structure and its technical operations.
Organizational structure of municipal PPS and its management capacity in PHC. Dimensions: organizational, operational and sustainability.

Workforce
Number of people able to participate in the social division of labour process.
Group of people with the capacity and ability to carry out PPS activities. Workgroups where tasks are performed.

Structure
Equipment or the physical structure required for the performance of system activities.
Structures and infrastructure by workgroup of the PPS system.

Processes
Main activities that are part of the system, including the main and routine activities Main activities by PPS workgroup in PHC. Why does the unit of work exist? How does it communicate with the system and the environment in its technical and relational aspects?
Technology Equipment and methods used to produce products or services. A health technology can be de ned as a way, knowledge and the instruments used to produce health actions.
Description of drug treatments and instruments used for their access, use and monitoring. Drug treatment: Criteria and places for selection, access and monitoring of outcomes. Instruments: Municipal List of Medicines, Electronic Health Record, protocol, computerized system.

Culture
Organizational culture of the system, the way it thinks and acts, the beliefs and values held in organization and society.
Organizational culture of PPS on three aspects. Symbols: names, logos and physical characteristics used to convey the organization's image. Rituals: usual and repeated actions within an organization. Ideology: beliefs, moral principles and values provide the basis for organizational decision making.

Ethical Aspects
This study is part of a project called "Application of Sociotechnical Theory in the Reorientation of Pharmaceutical Care in Primary Health Care". It was approved by the Univali Research Ethics Committee (CAAE: 28471320.2.0000.0120).All participants signed a written form of consent after having received information about the study. The analysis was based on an existing database and information on the process of reorienting PPS in PHC in four municipalities in Santa Catarina.We do not identify the municipality by name to prevent identifying individual participants. Individual participants indicated by professional title and job position.

Results
The results of the socio-technical evaluation of PPS in PHC will be presented below in two sections: 1 -organization of the environment in terms of stakeholders, objective; nancial circumstances and health funding, the general regulations and those related to PPS system performance; and 2 -description of the of socio-technical elements of PPS in PHC.

Organization of environment
In 2016, the sustainable municipal development index (IDMS) was 0.726 (scale from 0.00 to 1.00), a medium high level. In the economic and social participation dimensions, the levels were low (0.630) and medium low (0.524), respectively. The analysis of the health situation falls within a medium high level, with index of 0.798.In 2017, the municipality experienced weaknesses in the economic and political contexts, attributed to the impeachment of the mayor and the vice-mayor in 2015. This scenario was accompanied by a strict control process, especially in the acquisition of products, and in the hiring of services and sta ng by public management, with a nancial surplus at the end of 2016 [24].
The main stakeholders identi ed in the municipality's PPS were the social control council, municipal health department and the press. The Municipal Health Plan (2014-2017) embraces the guarantee of the dispensation of medicines from Municipal List of Medicines (called REMUME) and, secondarily, building a laboratory to produce herbal medicines. The Table 3 illustrates expectations and demands about PPS based on the summary of reports published in local media outlets. The demands regarding the results to be produced by PPS focus on the availability of medicines, given the understanding that the system failed to meet this expectation. The 2016 management report points out that "considering the high consumption of medicines by patients, this policy [PPS] was insu cient to reach its totality in the face of a lack of resources". The municipality's 2015 Annual Health Program (AHP) de ned the "Guarantee of pharmaceutical assistance within the scope of SUS" in its Guideline H translated into objective H1 of "Ensuring the availability of medicines to the population" with the following planning:

Goal of the Sociotechnical System of PPS in PHC
The data collected were described and referred by several stakeholders that affected the social and technical factors of PPS, as shown by the evidence below.
One promise of the mayor-elect campaign (2017-2020) was to increase the accessibility of medicines in health facilities. The government plan carried the slogan "Medicines basic and of chronic use to the entire needy community". In the municipal health plans (MHP) for the periods 2010-2013 and 2014-2017, the objectives focused on the accessibility of medicines, as described in Table 5. Purpose Goal 2010 to 2013 "The municipal PPS's main purpose is to provide regular and free supply of selected drugs, in order to contemplate the outpatient drug treatment of the different pathologies that affect the population".
-Ensure the supply of medicines to all SUS patients in accordance with the list of selected medicines.
-Constantly review the list of selected medicines.
2014 to2017 "Guarantee the dispensation medicinesof municipal list to the population". Implement the herbal medicine production laboratory.
-Consolidate drug purchase, dispensing and inventory control routines, and the use of the G-MUS management system to improve purchase and dispensing monitoring.   10 0 Responsibility for de ning the programming parameters for distributing medicines to health units.

0
Health units with pharmacists working in the team.

1
Pharmacists trained in PA, management, public health or related elds in the past 2 years.

2
Type of employment contract of the PPS coordinator.

0
Pharmacist position in the list of municipal public service positions.

7
Total 77 03 Infrastructure component Integration of the PA information system with that used in the health care network. 6 6 Instruments to assess physical and environmental conditions to store medicines (external and internal conditions, lighting, refrigeration, security). 6 3 Investments in infrastructure in the last 4 years in PPS services. Prescribed medicines based on lists of medicines adopted by the municipality.

6
Medicines out of date available for dispensing. 6 6 Health services have a waste management plan. 5 0 The pharmacist's productivity record has a de ned procedure. Schedule for regular distribution of medicines to health units: monthly, biweekly or weekly.

6
Prescribers receive information about the availability of medicines in pharmacies at health facilities.

7
Prescribers know how to nd updates to the municipal list of medicines. INSERT Table 6 Page 10/17

Workforce of municipal PPS in PHC
Ten indicators of Assessment Matrix of the Management Capacity of municipal PPS correspond to sociotechnical dimension 'workforce', according Table 6.
Coordination was the responsibility of two nurses and an administrative assistant. Six pharmacists were active staff of the PPS, two with a xed-term employment contract and four civil servants. The experience of pharmacists in the municipal health service ranged from 01 to 05 years.
Nursing technicians and assistants were the major workforce to dispense medicines in health facilities. There was no prede ned scale to work and the premise was "whoever is out of activity stays at the pharmacy". The health services coordination (usually a nurse) asked for medicines from the warehouse. In the Central Pharmacy Dispensing Unit (UD1), there were two pharmacists and six assistants (a nurse and ve administrative staff). These pharmacists planned PPS services in an independent way.
We found a pharmacist in the dispensing services in specialized care service center (UDI2). Two pharmacists and three assistants in specialized and judicial dispensing centers (UD2). And one pharmacist worked at the Pharmaceutical Distribution and Supply Center. In all these services, pharmacists planned PPS activities thenselves. None of the pharmacist had previous training to work in the public service or in PPS, nor have they received training in the area in the past two years.The quotes below show PHC professionals opinions about the pharmacists qualifying the healthcare processes: PHC manager: "When I was at the PHC, we didn't have this process in place yet, I can't say it was a mess because it was part of the process, but we have two or three technicians in each health center and each one who had a little time at the pharmacy and dispensing medication, with that we had a lot of puncture in the stock, there were several complications".
Family Health Strategy Doctor: "I believe that a pharmacist xed in the PHC center would help us a lot, due to the knowledge, you know, for being a quali ed professional for that. Although we have a technician in a nished shift, but we do not have the technical knowledge of that job, which has to be performed".

PPS Infrastructure and Processes in PHC
Infrastructure component has 03 indicators described in Table 6. We analysed 22 UDI in PHC, UD1 (PHC medicines) and the Pharmaceutical Distribution and Supply Center. All facilities had internal and external areas in good conditions, allowing hygiene. The structure offered no risk to patients and employees, meeting the recommended standards. We found computers and internet access in all units. Fifteen percent of facilities had insu cient number of computers.
These equipments had no technical maintenance for two years.An information system manages the stock of medicines in PHC. A third party company provides the system. Table 6. In 2017, PPS services performed 20,406 attendance, as shown in Table 7. In 2017, PPS services included scheduling, ordering purchases, storing and dispensing medications. The procurement department of the city hall held bids to buy medicines with no pharmacist participation. We observed no services related to: 1) discard health care waste (there is no Health Services Waste Management Plan); 2) review patients' pharmacotherapy or perform pharmacotherapeutic follow-up; 3) provide technical support for the health team or health education for patients and the community. There were no standard technical criteria for programming, purchasing, distributing and dispensing drugs. Only in Central Pharmacy Dispensing Unit (UD1) we found de ned routines and procedures. There was no procedures related to pharmaceutical care and matrix support for healthcare teams.

The processes component include 23 indicators. It was detailed in
Pharmacists inferred the lack of standardized technical parameters can compromise availability of medicines. The availability of drugs was only 60% and there was a large amount of drugs out of date.Several actors point to other de cits in PPS services. They attribute to this, problems in the work process, waste of products, lack of access and treatments with inferior quality. The quotes below illustrate the statements.
Secretary of Health: "... the current management found primary healthcare with 'unstructured teams by the lack of professionals', lack of medicines − 60% of the items listed in the Municipal List of Medicines, 500 kilos of expired medicines and an empty warehouse.
Pharmacists from Pharmaceutical Distribution and Supply Center: "When I started at the warehouse, our purchases were based on the transfers that we made to the health units and then these values, these amounts that we had, they were not very reliable, because they were not based on the real demand that we had in the units at that time".
"I worked in the health store, in the medication sector and in the period 2014-2016, we did not have stock control, we did not have the management of stock control in health units, nor which distributions in the stockroom. The distribution was made to health units once a month and that was the supply that the units have".
Family Health Strategy doctor: "We had a very serious problem, in terms of user access, the medications in the unit, a di culty due to the lack of professionals to take care of the medication release and this in uenced the entire work process of other professionals".
PHC center Coordinator: "So three years ago when I started in the municipality, at the health unit, PPS was very de cient in many ways, in the sense of stock control, waste, user guidance, professional guidance, that we didn't have a lot of accessibility to some information and guidance regarding the delivery of the medication and PPS.
PHC Manager: "When I was at the unit, we didn't have this process in place yet, I can't say it was a mess because it was part of the process, but we have two or three technicians in each health unit and each one who had a little time went into the pharmacy and dispensed medication. With that, we had a lot of puncture in the stock, and there were several complications like that. Even for the nurse, it was di cult to charge someone who was a continuous process and walked smoothly".

2.5Technology in PHC
The technology component consists of 05 indicators, detailed in Table 6. It includes drug treatment and the instruments for its access and monitoring. The municipality regulates the prescription and dispensing of medicines. It de nes facilities to provide pharmaceutical services, as indicated in Fig. 2

2.6Organizational culture in PHC
The organizational culture has 04 indicators ( Table 6). The pharmacists working in the municipal health system did not know each other. There was no integration strategy between pharmacists and their work processes. The organizational culture has 04 indicators. Some pharmacists working in the municipal health system did not know each other. There was no integration strategy between pharmacists and their work processes. Some evidences of these we can found in pharmacists citations.
Pharmacist of Central Pharmacy: "When I started working here …, there was no PPS, we worked, each pharmacist in his workplace. We didn't have any contact between us, some of us didn't even know each other and that made the job very bad and very unrelated".
Pharmacist of the Specialized Care Dispensing Center said: "Specialized service has always been a very isolated sector of PHC".
PHC workers expressed dissatisfaction with the lack of support for PPS actions. The nursing team managed the stock besides deliver medicines to patients.
This caused overload. The following quotes illustrate this point.
Pharmacist in Specialized and Judicial Dispensing Center: "Until 2017, the municipality did not have a policy for PPS, we had pharmacists working one in each pharmacy, in the PHC pharmacies, in the out, in the specialized pharmacy, each one worked individually, not as a team or a group".
Secretary of Health in 2017said: "When I arrived and took over the portfolio of the health department, PPS was quite confused, there was no line or better a municipal policy for PPS, and this is what we need today,. We are not only ensuring insuring costs or expenses, but working with what public money in a responsible way. So, we had a very messy house, a lot of expired medicine and put in stock, something that today we prioritize the right purchase, good purchase, right and something that each health center worked on dispensing medication in the way that best suits them".

Discussion
The results of this article revealed the complexity involved in a PPS system. A Municipal PPS is characterized as an open system and interrelates with the municipal management and the municipal health systems as described in Fig. 1. Within the sociotechnical approach, these larger systems represent the environment of the municipal PPS.
The used index shows sustainability as the balanced development of the social, cultural, environmental, economic, and political dimensions. Despite the political weaknesses, the studied municipality showed good economic development. Its health indicators have a high average level. Social participation was the only indicator that was below average [23]. We can better understand some aspects of the sociotechnical nature of PPS in this context in which it did not please stakeholders.
The aim of the organizational structure is identi ed as the central element of the model. The other system components interrelate with its scope. For municipal managers, health professionals, and users the lack of medicines was the main frustration. The central aim of the Municipal Health Plan and PPS was the same. It was "to have medicine available from the Municipal List of Medicines in the dispensing centers". This aim exposes a conceptual reduction. Ensuring access to medicines is making them available. A broader perspective comes from WHO: availability is a dimension of access to medicines. So are affordability, acceptability, and rational use of medicines [41,42]. In Brazil, access is the purpose of PPS and involves its many dimensions [4]. It is more complex than the mere availability of medicines.
Medicine availability is a key part ofthePPS architecture. This dimension can suffer many constraints. We need supply-side strategies to ensure medicine availability and help expand access to medicines in health care systems [43]. But when a PPS system chooses medicine availability as a central goal, its commitment is narrowed down to delivering medicines. Barreto and Guimarães, and Rover and Leite discussed the constraintsof this approach for PPS development in public health systems [8,6].
We identify weaknesses in the PPS management component generated. Lack of central coordination, pharmaceutical services with more than a manager, and a fragmented organization prevented integrated planning with other sectors (Fig. 2). At the health secretariat, there were no human resources available to plan the actions that involved the services. PPS issues were discussed and decisions were made with no integration of the directorates (PHC, specialized services, or warehouse). In 76% of Brazilian municipalities PPS coordination is nominated in the health department organization chart [10].
PPS has a management logic based on an input distribution model. The environment refers only to technical elements of the system: infrastructure, technical process, and technology. The social components of workforce and culture are not mentioned in the Municipal Health Plan. But, the organizations' reality is based on social components. People are essential sociotechnical elements, as well as the components affecting them [44]. The architecture of municipal PPS should not ignore general and organizational culture.
We did not nd working groups organized in the municipal PPS. The working group is considered the elementary construction of the sociotechnical structure.
Self-regulation, semi-autonomy, and speci c functions but with interrelated tasks are working group features. What connects the groups is to achieve a common goal. This increases the capacity to meet the demands of the internal and external environments [30].
The organizational culture established was the culture of isolation: "each one does their own". People working in the health system did not know each other in a municipality system with only 130,000 inhabitants. There were no shared symbols or collective rituals. The ideology was based on the care logic of contribution. The national pharmaceutical policy advocates PPS with a comprehensive approach to the health-disease process [8,9,10,11].
The distribution and dispensing centers' infrastructure is the indicator that showed the best result. The result is better than those observed in other municipalities in the state [45]. But, the infrastructure does not seem to be enough to provide articulated pharmaceutical services. This component is connected to the PPS aim, restricted to distributing medicines.
The processes of the municipal PPS emphasized medicine supply. We highlight the regulation of technical processes for making medicines available. It involved prescription, acquisition, inventory control, and dispensing. Even with technical components in focus, pharmacists did not take part in planning or executing scheduling and purchasing services. In most municipalities in the state, this process involves the pharmacist. This reality impacts on availability, reasonableness of costs, and sustainability of access. In view of the volume of nancial resources allocated, this aspect is fundamental [45]. Processes that need intersectionality and participation, such as a Pharmacy and Therapeutics Committee and participatory planning, have not been carried out either.
In the technology component, PPS management at PHC did not meet the needs of prescribers or patients. The problems involved both the diversity of medication available and their recurrent scarcity. Here the key factors are: the formal constitution of the Pharmacy and Therapeutics Committee; and the consumption of 10% of the budget bu the "non-selected medicines' program". In both situation, there were no de ned access criteria. These factors are like those found in the studies by Hoepfner and Gerlack [45,10].
We can understand the weaknesses of the municipal PPS by looking at some results obtained by the system. The resource used for the PPS (R$ 38.90 / inhabitant) is higher than the national or state average (R$ 20.00) [46]. Even with a high cost, the observed effects show professionals' and users' dissatisfaction as well as a waste of medicines. What works in one con guration may not work elsewhere. We must adapt improvements to the local context and check. The sociotechnical systems approach is capable of answering to local speci cities. It also helps to produce incremental results and contributes to building exible organizational structures [17,30]. Understanding the municipal PPS as a sociotechnical system contributed to developing an intervention The results presented here suggest that the municipal PPS is a complex system, like the one Appelbaum found [30]. In a sociotechnical intervention, there are many strengths. They should be used within a strategic plan for organizational development instead of as an isolated approach. Policymakers and managers should target their support to systemic solutions, rather than contributing to proliferate fragmented efforts.
Some limitations of this study need to be highlighted. One di culty is collecting data from different and poorly systematized sources. The lack of good electronic systems and transparency of public data weaken the ability to study this eld. The scarcity of references to sociotechnical systems applied to PPS required the adaptation of study instruments, such as the management capacity assessment protocol, besides using references from administration and sociology.

Conclusion
The study revealed that a municipal PPS implemented had limited scope as a public policy. It had constrained characteristics as a complex and open system.
Stakeholders understood PPS as a set of technical processes, without planning or integration. Its absence in the health secretariat organization's chart symbolizes the poor understanding of the system in its policy dimension.
The municipal PPS was a fragmented resource and produced unsatisfactory results. The aim focused on the availability of medicines; this subverts the logic of a system whose purpose is to provide access to medicines. PPS was reduced to the availability of the input, with a low capacity to promote advances in health care. Even if pharmacists had technical-scienti c training for developing clinical pharmaceutical services, the situation found in the municipality did not offer the minimum conditions for doing so.
PPS has had a great development in Brazil in the last twenty years. A new level requires a turning point of strategy to understand municipal PPS as a sociotechnical system. It will allow advancing its contribution to the health care process. Availability of data and material:

Abbreviations
All original data can be accessed by authors contact.
NLMB performed the data collection and analyses; LS contribute in analyses and discussion; SNL coordinated the project, the data analyses and nal writing. All authors have read and approved the manuscript.