REGISTRO DOI: 10.69849/revistaft/ma10202509261650
Rodrigo Salvo Henrique1
Abstract: This study analyzes the central role of the pharmacist serving as the Pharmacist-in-Charge (PIC) — a position legally defined in Brazil as Responsável Técnico (RT), or “Technical Responsible” — in health governance and pharmaceutical logistics, especially in crisis contexts such as the COVID-19 pandemic. Based on a bibliographic, documentary, and regulatory review, it is evident that the presence of the RT is a legal requirement, reaffirmed by decisions of the Superior Court of Justice (STJ) and by guidelines from the Federal Council of Pharmacy, making it an exclusive function of the pharmacist. The study shows that RT’s work goes beyond bureaucratic compliance, encompassing the implementation of quality management systems, development of standard operating procedures (SOPs), technical audits, supplier validation, and strategic planning, ensuring the traceability and integrity of health products. During the pandemic, their role was crucial in reorganizing inventories, creating contingency plans, and disseminating reliable scientific information, ensuring transparency, risk mitigation, and reduced shortages. From a social perspective, the RT contributed to equity in access to medicines, the protection of healthcare professionals, and the optimization of public resources, reinforcing their role as an agent of collective protection. The article also highlights persistent challenges, such as regional logistical inequalities and regulatory instability, while projecting future perspectives based on technological innovation, continuous training, and the strengthening of public policies. It concludes that the pharmacist RT — or PIC in international terms — should be recognized not merely as a technical inspector, but as a risk manager and a key factor in health security, whose strategic role is essential for the sustainability of supply chains and for the resilience of Brazil’s healthcare system both in emergency situations and in routine care.
Keywords: Health governance; Pharmaceutical logistics; COVID-19; Standard Operating Procedure (SOP); Optimization of public resources.
Pharmacist-in-Charge in Pharmaceutical Distribution
The role of the pharmacist as Pharmacist-in-Charge — legally defined in Brazil as Responsável Técnico (RT) — in distributors of medicines and health products is both a legal requirement and a fundamental practice to ensure the quality, safety, and traceability of supplies throughout the logistics chain. According to Collegiate Board Resolution (RDC) No. 304/2019, of the Brazilian Health Regulatory Agency (ANVISA), distributors must comply with “Good Distribution Practices (GDP), storage, and transportation of medicines,” ensuring that storage, transport, and handling conditions preserve product integrity until dispensing (Brazil, 2019). In this context, the RT is the legally responsible professional for supervising and validating all stages, acting as the technical and ethical guardian of regulatory compliance.
Brazilian legislation reinforces the exclusive nature of this role: as established by the Federal Council of Pharmacy (CFF), only pharmacists may serve as the technical responsible professional in wholesale companies and distributors of medicines. Their presence is mandatory during all operating hours, in accordance with Federal Law No. 5,991/1973 (art. 15, §1), Provisional Measure No. 2,190-34/2001, and Special Appeal No. 1,435,489 – DF (2014/0032955-0) of the Superior Court of Justice (STJ), issued in 2015. Beyond being a regulatory requirement, this obligation reflects institutional recognition that the distribution of medicines demands continuous oversight by a professional specifically trained in pharmacology, health legislation, and quality management (CRF-PI, 2015).
The pharmacist’s responsibilities as RT extend far beyond bureaucratic compliance with regulations. They include implementing quality management systems, drafting Standard Operating Procedures (SOPs), training employees, and overseeing infrastructure adjustments (Rodrigues et al., 2021). The professional must also validate suppliers, audit receiving and storage processes, ensure batch traceability, and prepare technical reports for public agencies or private partners. These duties place the RT at the core of maintaining the reliability of the pharmaceutical supply chain, especially in emergency contexts.
During the COVID-19 pandemic, the role of the pharmacist RT became even more strategic. Exceptional federal regulations, such as RDC No. 430/2020, introduced temporary flexibility in dispensing and logistics processes but maintained the pharmacist’s non-transferable technical responsibility. Documentary studies indicate that these professionals were engaged in stock reorganization, supplier negotiations, and the creation of contingency plans to mitigate shortages (Miranda & Silva, 2023). In addition, they contributed to disseminating reliable scientific information, reducing uncertainty, and strengthening institutional trust during the crisis (Lula-Barros & Damascena, 2021).
Therefore, the RT must be understood as a structuring pillar of health governance, as this role articulates legal, technical, and social requirements. On one hand, it guarantees compliance with sanitary regulations and ensures product integrity; on the other, it represents an instance of collective protection, by contributing to equitable access to medicines and health supplies. This centrality of the pharmacist RT in the logistics of medical products reinforces the need for public policies that expand and strengthen their inclusion in technical-strategic positions, consolidating their relevance not only as an inspector but also as a risk manager and leading actor in health security in Brazil.
Methodological Approach in Crisis Scenarios
The COVID-19 pandemic exposed structural weaknesses in the health supply chain and demanded immediate responses from professionals responsible for the distribution of medicines. In this context, the pharmacist’s methodology of action took on a strategic character, combining regulatory, technical-operational, and risk management practices to ensure the continuity of supply and the quality of products delivered to the population.
According to RDC No. 304/2019 (BRAZIL, 2019), distributors must comply with strict standards of Good Distribution Practices, covering everything from storage to transportation of medicines, under the direct responsibility of the RT. In a crisis situation, these requirements were maintained but adapted by emergency regulations, such as RDC No. 430/2020, which temporarily relaxed certain processes without removing the pharmacist’s obligation to ensure technical compliance (BRAZIL, 2020), as mentioned above.
Among the main methodological procedures adopted by RT pharmacists during the pandemic, the following stand out:
● Development and monitoring of Standard Operating Procedures (SOPs), focused on the receipt, storage, fractionation, and transportation of supplies in safe and traceable conditions (RODRIGUES et al., 2021).
● Continuous technical audits, carried out both in storage conditions and in transport vehicles, aiming to prevent failures that could compromise product integrity.
● Careful validation of national and international suppliers as a strategy to mitigate the risks of counterfeiting, quality deviations, and shortages in markets under pressure from high demand (MIRANDA; SILVA, 2023).
● Preparation of technical reports and contingency plans for public contracting agencies and institutional managers as a tool for communication and transparency (RODRIGUES et al., 2021).
● Adaptation of distribution to regional specificities, especially in states with poor logistics infrastructure, such as the North Region, requiring the integration of river and air transport (Henriques).
From a social and institutional point of view, the methodology applied by the RT pharmacist also involved the production and dissemination of reliable technical information, an essential element in combating misinformation and ensuring that managers and health professionals made evidence-based decisions (LULA-BARROS; DAMASCENA, 2021).
Thus, the RT’s methodology for acting in crisis scenarios cannot be understood merely as the application of regulatory protocols, but as an integrated management process that combines health compliance, technical auditing, strategic planning, and institutional communication. This approach, consolidated during the pandemic, demonstrated that the presence of the RT pharmacist is indispensable for health logistics governance, being able to articulate operational efficiency with the ethical commitment to protect life.
The Strategic Relevance of Pharmaceutical Practice
The presence of the pharmacist as Technical Manager (TM) in drug distributors transcends the role of mere enforcer of health regulations. Their work is strategic in nature, as it involves mediation between public and private actors, ensuring institutional reliability, and protecting public health. In contexts of health crises, such as the COVID-19 pandemic, this relevance has been amplified, as it has been demonstrated that the presence of the TR was decisive in ensuring continuity of supply and transparency in institutional relations (LULA-BARROS; DAMASCENA, 2021).
From a regulatory perspective, Brazilian legislation already recognizes pharmacists as central actors in health governance. The mandatory permanent presence of RTs in distributors, confirmed by the Superior Court of Justice (STJ), consolidated the exclusivity of pharmacists in the technical and strategic management of drug distribution (CRF-PI, 2015). This legal support shows that the role of the TR goes beyond a formal requirement: it is an instrument of institutional credibility, ensuring that companies comply with the quality and traceability standards established by ANVISA (BRAZIL, 2019; BRAZIL, 2020).
From a strategic point of view, the RT pharmacist performs crucial functions, such as validating national and international suppliers, coordinating technical audits, and preparing technical reports for public agencies in emergency procurement processes (RODRIGUES et al., 2021). These practices strengthen trust between distributors, public authorities, and society, reducing the scope for fraudulent practices or irregularities in supply.
Pharmaceutical activities also contribute directly to strengthening health governance. By implementing compliance and quality management methodologies, the TR not only ensures the integrity of the supplies distributed but also acts as a risk manager, anticipating logistical failures, identifying vulnerabilities, and proposing solutions that minimize impacts on the healthcare network (MIRANDA; SILVA, 2023). This proactive function reveals a strategic role that goes beyond technical supervision, taking the form of leadership in decision-making processes of great health relevance.
In addition, in emergencies, such as in the fight against COVID-19, the RT pharmacist has become a key player in enabling emergency contracts and public-private partnerships, as their presence lent technical legitimacy to negotiations. Documentary studies show that the inclusion of this professional was decisive for the implementation of public policies on pharmaceutical assistance and for reducing inequalities in access to medicines and supplies (LULA-BARROS; DAMASCENA, 2021).
Thus, the role of the RT pharmacist should be understood as a strategic element of health management, capable of articulating legal norms, operational practices, and ethical commitments in favor of health security. Strengthening the presence of this professional in leadership and decision-making positions, therefore, is not only a normative necessity but also an indispensable condition for the sustainability of health supply chains in Brazil.
Social and Sanitary Impacts of the Pharmacist-in-Charge
The role of the pharmacist as Pharmacist-in-Charge in drug distributors goes beyond technical and operational management: it has direct repercussions on public health and the reduction of social inequalities. During the COVID-19 pandemic, it became clear that the presence of the TR was essential not only for maintaining the integrity of the supply chain, but also for ensuring that the population had timely and equitable access to medicines, hospital supplies, and personal protective equipment (LULA-BARROS; DAMASCENA, 2021).
From a health perspective, the work of Pharmacist-in-Charge ensures the timely availability of diagnostic tests and critical supplies (SILVA; COSTA, 2022). The logistical agility coordinated by pharmacists enabled effective support to hospitals and basic health units, especially in more vulnerable regions, where logistical access difficulties could result in shortages and worsening of the crisis (MIRANDA; SILVA, 2023).
In the social field, Pharmacist-in-Charge played a decisive role in protecting the lives of health professionals and the general population by ensuring the continuous delivery of personal protective equipment (PPE) and essential medicines (RODRIGUES et al., 2021). This action contributed to preserving not only the safety of frontline workers but also the population’s confidence in the public and private institutions involved in responding to health emergencies.
Another significant impact concerns the optimization of the use of public resources through the application of technical criteria in the selection of suppliers and inventory management. RT pharmacists helped reduce waste and prevent inappropriate purchases, ensuring greater efficiency in public health spending. This represents a collective gain, as it reinforces the sustainability of the system and strengthens transparency in the use of resources allocated to crisis response.
Documentary studies confirm that the pharmaceutical assistance measures implemented during the pandemic were strategic in ensuring access to and continuity of treatment, especially for patients with chronic diseases who depended on regular medication to maintain their quality of life (LULA-BARROS; DAMASCENA, 2021). In this sense, the social impact of the RT’s work transcends immediate logistics, reaching the sphere of health equity by minimizing regional and socioeconomic inequalities in access to therapies and supplies.
In summary, the social and health impacts of the Pharmacist-in-Charge’s work demonstrate that this professional not only fulfills regulatory functions but also assumes a dimension of social and institutional leadership, articulating technique with ethics and a commitment to life. This role reaffirms the pharmacist as an indispensable agent of Brazilian public health, whose strengthening in strategic positions is a necessary condition for the resilience of supply chains in future crises.
Challenges and Future Perspectives
Despite the advances and the recognition of the importance of pharmacists serving as Pharmacist-in-Charge (RT) in pharmaceutical distributors, several challenges persist and hinder the full effectiveness of this role. The main ones include:
Uneven logistics infrastructure: in regions such as the Amazon, difficulties in land transport, dependence on river transport, and the high costs of air transport impose significant limitations on the distribution of supplies. This reality directly impacts the ability to respond to emergencies, making the RT’s role even more complex (Henriques).
Regulatory and fiscal instability: during the pandemic, ANVISA’s emergency measures, such as RDC No. 430/2020, relaxed procedures without altering the technical responsibility of pharmacists (BRAZIL, 2020). However, the lack of regulatory and budgetary predictability creates uncertainty for both professionals and companies (MIRANDA; SILVA, 2023).
Professional undervaluation: although the STJ and CFF have reaffirmed the mandatory permanent presence of pharmacists in distributors (CRF-PI, 2015), there are still attempts to relax this requirement, which reveals the need for greater institutional recognition of RT as a strategic agent and not just a regulatory one (CRF-MS, 2025).
To overcome these challenges, some future perspectives can be outlined:
● Strengthening public policies: it is essential that the State promote policies aimed at placing pharmacists in technical-strategic positions of greater leadership, expanding their role in the formulation of contingency plans and health supply strategies (LULA-BARROS; DAMASCENA, 2021).
● Investments in logistics innovation: the incorporation of digital technologies, such as real-time traceability systems and blockchain, can increase the safety and efficiency of distribution. These tools allow RT greater control over flows and greater responsiveness to incidents (SILVA; COSTA, 2022).
● Continuing education: continuing education programs promoted by universities, CFF, and CRFs are essential for RT pharmacists to be able to deal with new scenarios, such as global health emergencies, humanitarian crises, and challenges in the cold chain for biological medicines (RODRIGUES et al., 2021).
● International integration: Brazil’s participation in global cooperation networks, such as the World Health Organization (WHO) logistics guidelines, can strengthen the standardization of practices and consolidate the position of Brazilian pharmacists in the international debate on health security (WHO, 2020).
In summary, the challenges facing the future of RT pharmacists require structural responses that combine investments in logistics, professional development, and the strengthening of public policies. At the same time, they open up space for innovative perspectives, in which pharmacists are no longer seen only as inspectors but take on the role of risk managers and protagonists of health governance. Strengthening this role is essential for Brazil to respond effectively and equitably to future health crises.
Conclusion
The analysis developed throughout this study demonstrates that the role of the pharmacist as Pharmacist-in-Charge is an indispensable element of health governance. During the COVID-19 pandemic, it became clear that this role goes beyond the regulatory dimension, assuming a strategic and social character, capable of articulating legal requirements, technical methodologies, and ethical commitments in favor of protecting life.
The RT pharmacist was responsible for ensuring the quality, traceability, and regulatory compliance of the medicines and supplies distributed, in addition to implementing audits, validating suppliers, and coordinating logistical contingency plans in crisis situations. These technical aspects, supported by standards such as RDC No. 304/2019 and RDC No. 430/2020, demonstrate that the pharmacist’s presence guarantees the continuity of supply and the integrity of the healthcare supply chain.
At the same time, the results highlight that the relevance of the RT pharmacist goes far beyond regulatory compliance. Their work generated significant social impacts, such as reducing inequalities in access to medicines, protecting healthcare professionals and vulnerable communities, and optimizing public resources, thereby reinforcing their role as a central actor in public health.
The challenges identified — including regional inequalities in logistics infrastructure, regulatory instability, and professional undervaluation — underscore the need to strengthen public policies, invest in logistics innovation, and promote continuous professional training. Such measures are fundamental to consolidating the pharmacist’s role as both a risk manager and a key player in health security.
It can therefore be concluded that the RT pharmacist is more than a technical inspector: they are strategic managers and social agent, whose work is essential to the effectiveness of the health system in routine contexts and, above all, in health emergencies. Recognizing and reinforcing this role represents a decisive step toward improving health governance, ensuring greater equity in access to supplies, and enabling faster, safer, and more sustainable responses to future crises.
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1Rodrigo Salvo Henriques has a degree in Pharmacy and Biochemistry from Nilton Lins University and is the technical manager of R S HENRIQUES COMÉRCIO E REPRESENTAÇÕES EPP