The Rational Use of Antimicrobials as a Compliance Strategy in Secondary Public Health Units

Franciny Marques Gastaldi; Lucas de Souza Lehfeld

DOI: 10.22167/2675-6528-202602925

Article derived from a Course Conclusion Work (TCC), with content based on the student’s original work and adapted to the editorial format of the E&S Magazine with the support of the ResumeAI tool, an artificial intelligence solution developed by Instituto Pecege for textual synthesis and organization.

Summary

Antimicrobial Management Programs (AMPs) promote the control of rational antimicrobial use, combating resistance and improving patient safety. The study aimed to describe the implementation of an AMP, integrated with a compliance policy, in public secondary care units of a medium-sized municipality in the Southeast region of Brazil. A descriptive study was conducted, focusing on the gradual implementation of the program starting in November 2023. The process involved infectious disease physicians from Hospital Infection Control and responsible technical pharmacists, developed in stages for the elaboration of institutional protocols. Data were systematically collected and care and management indicators were monitored, such as prescription compliance, antimicrobial consumption, and therapeutic de-escalation rate. The results indicated an improvement in the standardization of practices, resulting in a more rational indication and use of antimicrobials. Non-conformities and weaknesses in the process were also identified. The implementation of the AMP contributed to the strengthening of the institutional compliance policy, enabling better risk management and patient safety, and positively impacted the use of resources in the health unit.

Keywords: Health governance; Care indicators; Patient safety.

1. Introduction

The rational use of antimicrobials, known as Stewardship, represents a set of essential actions for public health. These actions involve the standardization of norms, flows, and responsibilities, aiming to ensure the correct prescription, dispensing, and administration of antimicrobials. Such practices are based on evidence-based medicine and require continuous multiprofessional training (ANVISA, 2017).

In this scenario, the compliance policy emerges as a strategic tool to structure and strengthen the rational use of antimicrobials, especially in secondary care health units. The implementation of a compliance policy implies the creation of a robust internal program, focused on auditing, identifying, and communicating irregularities. This is materialized through the implementation of evidence-based internal guidelines, preventing deviations and non-conformities that could compromise the integrity of the population and institutional management (Decree No. 11.129/2022).

The National Health Surveillance Agency (ANVISA) has emphasized the need for actions to combat antimicrobial resistance (AMR) since 2017, with the publication of the National Guideline for the Development of a Program for the Management of Antimicrobial Use in Health Services. AMR is a global health challenge, with data reinforcing its growing concern (WHO, 2024).

Regulatory documents such as RDC No. 471/2021, which establishes criteria for the prescription and control of antimicrobials, and Technical Note GVIMS/GGTES/ANVISA No. 06/2021, which guides the implementation of Antimicrobial Use Management Programs (PGA), are crucial. Ministry of Health Ordinance No. 2,616/1998 also defines guidelines and standards for the prevention and control of hospital infections, including the appropriate use of these medications.

The Healthcare-Associated Infection Control Program (PCIRAS) has, among its objectives, direct action in preventing AMR. This occurs through the monitoring and improvement of institutional programs, such as the PGA, to rationalize the prescription of these medications and ensure the safety of the environment and the patient. AMR, due to its environmental and social impact and its close relationship with the governance of health institutions, must be recognized in the risk matrix and addressed within their strategic map.

The alignment between high governance and the PCIRAS’s performance, especially in preventing healthcare-associated infections, makes it essential to develop policies that manage norms and guidelines. These policies should be based on current legislation and aim to promote the adoption of best practices within the organization. The absence of structured programs for antimicrobial management in secondary healthcare units represents a practical gap that compromises patient safety and treatment effectiveness.

The implementation of Antimicrobial Management Programs (AMPs) enables more effective control over the rational use of these medications, directly impacting the reduction of antimicrobial resistance and the improvement of patient safety. Continuous monitoring, through indicators, is an essential strategy to track the performance of the AMP and support continuous improvement interventions (ANVISA, 2017).

Thus, the implementation of an AMC contributes to strengthening institutional compliance policy, promotes more robust risk management, and increases patient safety, reflecting positively on the use of available resources in health units. The objective of this work was the design of the implementation of an Antimicrobial Management Program as part of the compliance policy of an institution responsible for managing secondary care health units (Urgent Care Units).

2. Material and Methods

The present study was characterized as a descriptive research, with a methodological approach focused on the gradual implementation of an Antimicrobial Management Program (AMP). The central objective was to describe the implementation process of this program in secondary care health units, integrating it into a policy of institutional compliance. The research was conducted in a medium-sized municipality, located in the interior of the Southeast region of Brazil, where the management of health units is carried out by a third-party company contracted by the Municipal Government.

During the study’s preparation, the Term of Consent was waived, as the analysis was based exclusively on aggregated and non-identifiable data. No information that would allow direct or indirect identification of patients or professionals involved was accessed or used, preserving the confidentiality and privacy of the information.

The study was not submitted to the Research Ethics Committee (CEP), in accordance with Article 1, sole paragraph, item V, of CNS Resolution No. 510/2016, and also by CNS Resolution No. 674/2022. These regulations establish that research conducted with aggregated databases, without individual identification, does not require registration or evaluation by the CEP/CONEP System.

The research was developed in four secondary care units (Units nº 1, nº 2, nº 3, and nº 4) in the municipality. These units are responsible for approximately 50% of the city’s secondary care services, covering an area of about 350,000 inhabitants. The selection of these units was due to the patient profile and the impact on the volume of antimicrobial prescriptions.

The participants involved in the program implementation were infectious disease physicians responsible for the Hospital Infection Control (CCIH) of the units and responsible technical pharmacists. The antimicrobial management program was created in November 2023, through the interaction between the hospital pharmacy team and the infectious disease physicians from CCIH, according to Collegiate Board Resolution No. 48, of June 02, 2000.

The implementation of the PGA occurred in distinct phases. The first phase consisted of defining the units and participants. The secondary care units were chosen due to their emergency care structure focused on severe or potentially severe patients, triaged by the Manchester tool, and the complexity of the cases.

The second phase involved the generation of institutional protocols. After meetings between collaborators and bibliographic review, the PGA was created and officially implemented. Complementarily, the Protocol for the Treatment of Main Infectious Syndromes and the Antimicrobial Table, updated according to the glomerular filtration rate, were elaborated, serving as guides.

The third phase was dedicated to data collection, selected according to the national guideline on the subject (ANVISA, 2017). The information was collected manually and daily by the CCIH team, with spreadsheet compilation by the infectious disease specialist. The first evaluation focused on the prescription of antimicrobials and global compliance, with monitoring by consumption indicators, such as Days of Therapy (DOT) and Length of Therapy (LOT).

In the fourth phase, the data were presented to those involved. Starting in March 2024, a monthly meeting was standardized, on the last Thursday of the month, between representatives of the pharmacy and the CCIH. These meetings aimed at presenting the collected data, allowing for critical discussion and analysis to identify opportunities for resource optimization.

The fifth phase, initiated in January 2025, focused on the implementation of new indicators for monitoring. The following were defined: compliance rate of broad-spectrum antimicrobials prescribed during hospitalization; de-escalation rate of broad-spectrum antimicrobials during hospitalization; de-escalation rate to oral antimicrobial regimen in patients with pulmonary infection who were discharged; and compliance rate in the prescription of antimicrobials in day hospital.

The first indicator assessed the assertiveness in the prescription of broad-spectrum antimicrobials (cefepime, piperacillin-tazobactam, meropenem, polymyxin, vancomycin, or teicoplanin) in each unit. The assessment was performed by the infectious disease specialist, considering dose, spectrum, and focus of treatment. The second indicator assessed whether broad-spectrum antimicrobials were de-escalated to lower-coverage medications during hospitalization, as guided by the infectious disease specialist, with initial pharmacist approach.

The third indicator involved the charting of patients diagnosed with pulmonary focus infection who were discharged from the hospital, verifying the transition from intravenous antimicrobial therapy to oral medication. The fourth indicator analyzed 30% of medical prescriptions in a day hospital setting (intramuscular or intravenous administration), evaluated by dose, focus, and spectrum.

The sixth phase, monitoring of indicators, began in September 2025. The data analysis technique consisted of a critical analysis of the collected data and the results of the indicators. This analysis was presented to institutional leadership to strengthen the strategy and link it to the organizational culture, reinforcing the performance of the pharmacy and CCIH sectors.

As part of the action plan for the indicators, existing protocols were improved or new ones were created. These documents, including the Antimicrobial Table with doses adjusted by weight and glomerular filtration rate, and treatment protocols for infectious syndromes and sepsis, were made available in digital and physical formats in strategic locations such as the pharmacy, prescription room, and consulting rooms.

3. Results and Discussion

The implementation of the Antimicrobial Management Program (AMP) in the four secondary care units of the municipality, initiated in November 2023, revealed an initial scenario of absence of systematic measurement of antimicrobial prescription and consumption data before the second half of 2024. The compiled data covered the first 18 months of operation, providing a basis for evaluating the program’s impact. The units, which serve an average of 11 to 14 thousand patients per month and cover approximately 90 thousand inhabitants each, presented a number of hospitalizations that varied between 250 and 350 patients monthly, influenced by seasonal factors such as dengue or respiratory syndrome epidemics.

The initial analysis of the period from July 2024 to December 2025, after the start of data collection, showed fluctuations in the number of antimicrobials prescribed for inpatients in all units. It was observed that Unit 1 and Unit 3, which are reference centers for adult clinical care and traumatology, and Units 2 and 4, which handle adult clinical care and pediatrics, presented varied prescription patterns throughout the months. For example, Unit 1 recorded approximately 250 prescriptions in July 2024, with peaks and troughs that repeated, while Unit 3 showed similar behavior, but with slightly different values, indicating the complexity and variability of the use of these medications in the hospital setting.

Regarding the average duration of antimicrobial use in hospitalized patients, data for the same period (July 2024 to December 2025) also revealed variations among the units. Although there was no prior measurement, the introduction of the PGA allowed for monitoring, identifying that the average treatment duration fluctuated between three and five days in most units, with some isolated peaks and drops. This variability suggests the need for standardization and optimization of conduct, one of the program’s central objectives, aiming to reduce patients’ exposure time to these medications and, consequently, decrease the risk of antimicrobial resistance.

Compliance rate of broad-spectrum antimicrobials prescribed during hospitalization

The first indicator implemented, the compliance rate of broad-spectrum antimicrobials prescribed during hospitalization, aimed to quantify the assertiveness in prescribing these medications. The evaluation performed by the infectious disease specialist considered the dose (adjusted for weight or glomerular filtration rate), the spectrum (need for coverage for hospital or community germs), and the coverage for the infectious focus being treated. The choice of hospitalized patients allowed for early intervention and control of use from the beginning to the end of therapy, aligning with the principles of rational and safe use.

The interferences identified for this indicator included the patient’s prior unknown glomerular filtration rate, the waiting time for test results, the prescriber’s experience with certain drugs, and the difficulty in determining or confirming the infectious focus in an emergency care setting, which requires speed. The criticality in prescribing high-cost antimicrobials with a greater impact on bacterial resistance, in addition to potential adverse events, reinforces the importance of action plans to mitigate these risks and optimize therapeutic outcomes, as recommended by health compliance guidelines.

Compliance data in the prescription of the first dose of broad-spectrum antimicrobials, collected in 2025, showed variable rates among the four units, generally ranging between 60% and 90%. For example, in January 2025, Unit 1 registered a compliance of approximately 85%, while Unit 4 presented about 75%. Throughout the year, all units exhibited monthly fluctuations, with some reaching peaks close to 95% and others falling to around 60%. These variations indicate the need for continuous monitoring and targeted interventions to ensure adherence to protocols and improve prescription quality, contributing to patient safety and risk management.

De-escalation rate of broad-spectrum antimicrobials during hospitalization

Complementary to the first indicator, the de-escalation rate of broad-spectrum antimicrobials during hospitalization aims to generate corrective actions for non-conformities. The initial prescription approach is carried out by the pharmacist, followed by a second evaluation by the infectious disease specialist, who participates in the case discussion with the care team. This two-step methodology allows for a more in-depth analysis, considering the patient’s diagnosis and clinical conditions, such as renal or hepatic diseases, which can influence the choice and dosage of antimicrobials.

The objectives of this approach are multifaceted, encompassing environmental, social, and governance aspects. In the environmental scope, the aim is to reduce unnecessary exposure of bacteria to broader-spectrum antimicrobials, minimizing selective pressure for resistance development. From a social and patient perspective, the focus is on clinical impact, prioritizing lower-spectrum drugs and shorter treatment durations to resolve the infection, avoiding negative impacts on gut flora and ensuring safety. In terms of governance, cost management and resource optimization are crucial, as waste impacts availability for future care, reinforcing the importance of efficiency in healthcare.

The interferences identified for this indicator include the availability of medications for exchange, such as the lack of Piperacillin-tazobactam, which can lead to the use of broader-spectrum carbapenems. The high patient turnover in emergency care, with an average length of stay between three and five days, also hinders the infection specialist’s approach, especially on weekends. These factors limit the ability to optimally de-escalate therapy, impacting the PGA’s effectiveness and resource optimization, requiring adaptive strategies to overcome such challenges.

The analysis of the de-escalation rates of broad-spectrum antimicrobials in Units 1, 2, 3, and 4, throughout 2025, revealed distinct patterns. In Unit 1, for example, the proportion of cases with an indication for de-escalation that were effectively de-escalated (Performed Desc./Susp.) fluctuated, but often remained below the proportion of cases with an indication. In February 2025, Unit 2 showed a peak in performed de-escalation, reaching about 80% of indicated cases, but in other months, such as April, this rate was significantly lower, around 20%. Units 3 and 4 also showed variations, with Unit 3 presenting performed de-escalation rates that, in some months, exceeded 80%, while Unit 4 had months with lower rates, such as 40% in March. This data indicates that, although de-escalation opportunities exist, their actualization still faces challenges, requiring continuous and targeted interventions to optimize clinical practice.

From a compliance perspective, monitoring de-escalation rates is an essential risk management tool, allowing the identification of inappropriate situations and timely intervention. This approach aligns with Soares’ (2022) vision, which integrates compliance with the concepts of governance, risk, and integrity, strengthening organizational control mechanisms. Applying this understanding to the PGA transforms care indicators into governance instruments, capable of supporting strategic decisions, mitigating risks associated with the inappropriate use of antimicrobials, and consequently, strengthening patient safety.

De-escalation rate for oral antimicrobial regimen, in patients diagnosed with pulmonary focus infection who were discharged from hospital

The third indicator focused on the de-escalation rate to an oral antimicrobial regimen in patients diagnosed with a pulmonary focus infection (pneumonia) who were discharged from the hospital. The choice of pulmonary focus is justified by representing the largest percentage of infectious processes in hospitalized patients. The evaluation of pneumonia treatment optimization is crucial, as a shorter treatment time directly impacts direct costs (medications, exams) and indirect costs (bed occupancy, professional care), in addition to contributing to the reduction of antimicrobial resistance and patient safety.

This indicator is considered to have greater interference due to factors such as the length of stay of patients due to pending issues unrelated to the infectious process (e.g., oxygen suspension, complementary exams) and the variable availability of adequate oral drugs for the continuity of pneumonia treatment. The diversity of patients requires multiple drug options, considering allergies, drug interactions, dosage, and tolerance. The difficulty in measuring the impact on bed turnover, exposure to invasive procedures, and time/resources spent per patient, although known, represents a challenge for the complete evaluation of the benefit.

De-escalation data for oral drugs in hospitalized patients with pneumonia who were discharged, referring to 2025, showed that rates varied between units and over the months. In January 2025, Unit 1 presented an oral de-escalation rate of approximately 70%, while Unit 2 registered about 85%. Throughout the year, fluctuations were observed, with Unit 3 reaching peaks of over 90% in some months, and Unit 4 showing an average of approximately 75%. These variations indicate that, although de-escalation to oral administration is a common practice, there is still room for optimization and standardization, especially considering the impacts on bed turnover and exposure to hospital risks.

Compliance rate in the prescription of antimicrobials in a day hospital

The fourth indicator, the compliance rate in the prescription of antimicrobials in day hospitals, expands the view of antimicrobial consumption to generally non-severe infections, administered daily in the health unit. This indicator is relevant due to the impact on the number of attendances and patient exposure to the hospital environment. The analysis of prescriptions in this context aims to ensure the adequacy of treatment and the optimization of resources, even in less complex cases, contributing to the safety and rationality of antimicrobial use.

The interferences in this indicator are significant, including the lack of knowledge of all prescribed drugs and the dependence on manual records filled out by the on-call physicians. The evaluation of patient adherence to the prescribed medication and daily dosage is not feasible without individual search, which is impractical with the current staff. The scarcity of clinical information in the medical records also interferes, requiring continuous improvement of records to ensure data security. These limitations in data collection and analysis impact the scope of the evaluation.

Despite the interferences, the potentialities of this indicator justify its continuity. It allows the identification of points for improvement, even with a reduced amount of data, for subsequent approaches to collaborators, following the concept of a just culture, which focuses on improvement and not on penalization. There is the possibility of actively searching for patients with inadequate treatment and understanding the profile of patients attended in each unit, which can support training or dissemination of consultation material for prescribing professionals, promoting continuous improvement and education.

Compliance data in prescriptions for daily administration in the emergency department, referring to 2025, indicated a relatively high consistency, with most units maintaining rates above 80% throughout the year. Unit 1, for example, registered a compliance of approximately 88% in January 2025, and Unit 4 remained around 85% in most months. Although there were small monthly fluctuations, the general stability of these rates suggests good adherence to existing protocols, but also points to the importance of continuing monitoring to identify and correct any deviations, ensuring the quality and safety of day hospital treatment.

As an action plan for the indicators, existing protocols were created and improved, made available in digital and physical format. Among these documents, the Antimicrobial Table with doses adjusted by weight and glomerular filtration rate, the Protocol for the Treatment of Major Infectious Syndromes (including concept, diagnosis, and treatment options), and the Sepsis Protocol (with concept, diagnosis, and treatment options) stand out. These guides aim to standardize conduct and provide support to professionals, ensuring that clinical decisions are aligned with best practices and scientific evidence.

The creation of these institutional mechanisms, based on current legislation and literature, and guided by professional ethics, guarantees risk management and the reduction of negative impacts on the institution. The systematic identification of non-conformities through indicators allows the PGA to transcend a merely normative performance, transforming assistance data into tools to direct institutional actions. This approach, according to Saad-Diniz (2019), overcomes a defensive performance, incorporating scientific evidence to guide decision-making, bringing antimicrobial management closer to an effective strategy of integrity and continuous improvement.

From the ESG (Environmental, Social, and Governance) perspective, the benefits of PGA go beyond compliance. On the environmental pillar, reducing the unnecessary use of antimicrobials contributes to decreasing the generation and release of pharmacological waste into the environment, and to reducing the selective pressure that leads to microbial resistance. Although measuring this impact is complex and indirect, it reinforces the importance of rational use as a sustainability strategy. On the social pillar, the program promotes patient safety by reducing unnecessary exposure to antimicrobials, preventing adverse events, and qualifying care, evidencing the positive impact on the quality of care.

The sustainability of the PGA depends on continuous investments in human resources, training, structure, and monitoring tools, considering the short, medium, and long-term assistance, financial, and institutional benefits observed. The institutionalization of the PGA as a permanent organizational policy, with formally defined responsibilities and indicators, is fundamental to reducing the program’s vulnerability to changes in management or team composition. This approach ensures the continuity of actions for rational antimicrobial use, risk management, and patient safety protection, regardless of changes in leadership or organizational structure.

In summary, the implementation of the Antimicrobial Management Program, through the monitoring of compliance and de-escalation indicators, demonstrated the ability to standardize conduct, identify weaknesses, and optimize resource use in secondary care units. The results indicated improvements in prescription rationality and risk management, strengthening the institutional compliance policy and contributing significantly to patient safety and the environmental and social sustainability of health practices.

4. Conclusion

This study aimed to describe the implementation of an Antimicrobial Stewardship Program (ASP), integrated with a compliance policy, in public secondary care units of a medium-sized municipality. It was observed that the gradual implementation of the program, initiated in November 2023, allowed for the standardization of practices and more rational use of antimicrobials, despite the initial absence of systematic data measurement. Over 18 months, fluctuations in the number of prescriptions and average duration of use were observed, with the introduction of care and management indicators. The compliance rate for broad-spectrum antimicrobial prescriptions generally ranged between 60% and 90%, while de-escalation rates showed variations, indicating opportunities for improvement. The implementation of the ASP contributed significantly to strengthening the institutional compliance policy, enabling more robust risk management and enhancing patient safety, in addition to positively impacting resource optimization in health units.

However, fragilities were identified in the process, such as dependence on manual data collection, scarcity of complete clinical information in medical records, and challenges related to drug availability and high patient turnover, which limited the full effectiveness of some interventions. To mitigate these limitations, institutional protocols were developed and improved, such as adjusted dose tables and treatment guidelines for infectious syndromes and sepsis, made available in digital and physical formats. The PGA’s performance transcends mere regulatory compliance, transforming care data into strategic tools for governance and integrity. From an ESG perspective, the program demonstrated environmental benefits through the reduction of unnecessary antimicrobial use and social benefits by promoting patient safety. The sustainability of the PGA requires continuous investment in human resources and technology, suggesting the incorporation of digital tools and artificial intelligence to automate data collection and analysis, and the institutionalization of the program as a permanent policy to ensure its continuity and expansion, including to primary care.

Bibliographic References

BRASIL. Agência Nacional de Vigilância Sanitária (ANVISA). Diretriz Nacional para Elaboração de Programa de Gerenciamento do Uso de Antimicrobianos em Serviços de Saúde. Brasília: ANVISA, 2017. Disponível em: https://www.gov.br/anvisa/pt-br/centraisdeconteudo/publicacoes/servicosdesaude/publicacoes/diretriz-nacional-para-elaboracao-de-programa-de-gerenciamento-do-uso-de-antimicrobianos-em-servicos-de-saude.pdf/. Acesso em: 25 set. 2025.

BRASIL. Agência Nacional de Vigilância Sanitária. Resolução RDC n.º 48, de 02 de junho de 2000. Aprova o Roteiro de Inspeção do Programa de Controle de Infecção Hospitalar. Disponível em: https://bvsms.saude.gov.br/bvs/saudelegis/anvisa/2000/rdc0048_02_06_2000.html. Acesso em: 25 set. 2025.

BRASIL. Decreto nº 11.129, de 11 de julho de 2022. Regulamenta a Lei nº 12.846, de 1º de agosto de 2013, que dispõe sobre a responsabilização administrativa e civil de pessoas jurídicas pela prática de atos contra a administração pública, nacional ou estrangeira. Brasília, DF: Presidência da República, 2022. Disponível em: Presidência da República – Decreto nº 11.129/2022. Acesso em: 10 ago. 2026.

Resolução CNS n° 510/2016 [Referência completa não encontrada no documento original]

Resolução CNS n° 674/2022 [Referência completa não encontrada no documento original]

SAAD-DINIZ, Eduardo. Ética negocial e compliance: entre a educação executiva e a interpretação judicial. 1º ed. Revista dos Tribunais, 2019.

SOARES, Fábio Lopes. Compliance: fundamentos e reflexões sobre integridade nas empresas. 2. ed., 2. tiragem. Rio de Janeiro: Lumen Juris, 2022.

WORLD HEALTH ORGANIZATION (WHO). Global Antimicrobial Resistance and Use Surveillance System (GLASS): data visualization dashboard. Geneva: World Health Organization, 2024. Surveillance data for the period up to 2022. Available at: WHO – GLASS Data Visualization Dashboard. Accessed: 2 Oct. 2025.

Article originating from the Final Course Work of the Specialization in Compliance and ESG of the MBA USP/Esalq

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