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THE (IN)EFFICIENCY OF THE NATIONAL CONTROLLED PRODUCTS
MANAGEMENT SYSTEM - SNGPC IN MANAGING MEDICINES SUBJECT
TO SPECIAL CONTROL IN THE PHARMACEUTICAL CHAIN IN BRAZIL
- A CRITICAL ANALYSIS
Lincoln Ferreira de Oliveira1
Abstract: This course conclusion work has as its theme The National Controlled Products Mana-
gement System-SNGPC and its ineciency in real control in the pharmaceutical chain. The central
proposal of the study is to critically analyze the SNGPC, a system created by the government with
the aim of controlling and monitoring the movement of controlled medicines in the country, from
their production to nal consumption. The main objective is to highlight that, since its creation, the
SNGPC has presented signicant failures in managing the distribution chain of these products. These
failures have important consequences, as they can lead to a lack of these medicines in some regions
and an excess in others, in addition to facilitating the occurrence of illegal practices such as sale wi-
thout a prescription or even diversion into tracking. The guiding question of the research is: Did
the SNGPC control the movement of medicine distributors to drugstores or was the control only for
pharmaceutical retail? This question is fundamental to understanding whether system failures are
concentrated at a specic point in the chain or whether they are diuse. The methodology employed
involves a comprehensive bibliographical review on the topic and also a detailed analysis of ocial
SNGPC reports and other relevant government documents. It is hoped that this study can contribute
to a better understanding of the challenges faced by the SNGPC and inspire proposals to improve its
functioning, thus ensuring greater eectiveness in the control of controlled medications in the country.
Keywords: medicines, products, management, system
1 Specialist in Regulatory Aairs in the Pharmaceutical Industry from Faculdade Iguaçu
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Introduction
The pharmaceutical industry is one of the most regulated in the world, with several control
bodies and systems to ensure the safety and eectiveness of medicines distributed to the population. In
Brazil, one of these systems is the National System in Management in Products Controlled (SNGPC),
created in 2007 by the National Health Surveillance Agency (ANVISA) with the aim of tracking and
monitoring the movement of controlled medicines in the pharmaceutical chain (ANVISA, 2016).
However, despite its creation being motivated by the need for a control more eective about
those products, studies recent he has pointed signicant aws in the SNGPC. In particular, The question
arises whether the system has been ecient in controlling the movement of medicine distributors to
drugstores or whether this control is restricted to pharmaceutical retail (Melo et al., 2018).
The present work aims to discuss this issue, seeking evidence that can clarify the role of
SNGPC in the pharmaceutical chain. Through critical analysis of the system and studies published on
it to date, intended to understand which they are to the your limitations It is as they can be overcome
to improve the management of controlled products in the country.
Since the creation of the National Controlled Products Management System (SNGPC) by
the National Health Surveillance Agency (Anvisa) in 2007, the eectiveness of the system has been
constantly questioned. The SNGPC was designed for to allow one management more ecient from
the chain in distribution of controlled products and substances subject to special control, but, despite
the technological advances associated with the implementation of the system, there are still several
aws that prevent complete control (Ribeiro et al., 2016).
To better understand these aws, it is important to rst understand the basic functioning
of SNGPC. The system was created to monitor the distribution of controlled medicines and other
substances that require special regulation in Brazil. The idea was to provide stricter control over the
pharmaceutical supply chain and reduce the risk of abuse and misuse of these products (Figueiredo
et al., 2019).
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However, since its implementation, the SNGPC has presented several aws in its functioning.
One of the main issues is related to the fact that the system concentrates its eorts only on pharmaceutical
retail, leaving gaps in the supervision of distributors. The lack of control over distributors may allow
controlled medications to be sent to drugstores without Anvisa’s knowledge or approval, potentially
contributing to the diversion and misuse of these products (Gomes et al., 2020).
Therefore, the research question is pertinent: Did the SNGPC control the movement of
medicine distributors to drugstores or was the control only for pharmaceutical retail?
Revision from the Literature
O System National in Management in Products Controlled (SNGPC) is a computerized
tool that aims to control the sale of medicines subject to special control in Brazil, as established by
National Health Surveillance Agency (ANVISA). Despite its purpose, several studies have questioned
the eciency of the SNGPC in controlling the pharmaceutical chain.
One study accomplished per Santos et al. (2018) pointed what The Implementation of the
SNGPC still presents many challenges, especially in relation to the lack of standardization of processes
and the underreporting of sales of controlled medicines. The research also highlighted the need for
adequate training of professionals involved and from the improvement at infrastructure technology
for ensure ecient functioning of the system.
Another study, conducted by Silva et al. (2019), identied that the SNGPC faces problems
related to information management, such as diculties in integrating data between dierent levels of
the system and guaranteeing the reliability of recorded information. The authors suggest the need to
create mechanisms to verify and validate the data entered into the system to improve its eciency.
Furthermore, an ANVISA report (2017) recognized that the SNGPC has limitations signicant
what harm your performance, including frequent technical problems, unfriendly interface and lack of
essential functionalities for eective management of controlled products. The report highlighted the
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need to modernize the system to overcome these diculties.
The ineciency of the National Controlled Products Management System (SNGPC) at
reality of control from the chain pharmaceutical he has been object of study by several researchers.
According to Souza e Silva (2018), the SNGPC presents deciencies in terms of traceability and
transparency, in addition to failures in monitoring the logistics of controlled medicines.
The system was implemented with the aim of improving medication control, nonetheless, yet
they exist weaknesses what compromise your eciency. According to Santos et al. (2019), the SNGPC
has not proven ecient in avoiding deviations It is cheats at chain pharmaceutical, then lots of times
to the irregularities only are detected after external audits.
The lack of integration between the various bodies involved in drug control is also a factor
that contributes to the ineciency of the SNGPC. According to Lima and Costa (2020), the lack
of eective communication between regulatory agencies makes it dicult to monitor and inspect
activities related to controlled medicines.
Furthermore, failures in the training of professionals who operate the system they are other
point critical in this question. For Pereira It is Oliveira (2021), many of the shortcomings of SNGPC
could to be minimized with one training of users, especially those directly involved in the handling
of controlled medications.
The ineciency of the National Controlled Products Management System (SNGPC) is widely
discussed in the literature. According to Santos et al. (2019), poor management of the pharmaceutical
chain can lead to drug shortages, which has direct implications for public health. The SNGPC, despite
to be one tool developed for promote O control It is The traceability of medicines throughout chain
pharmaceutical, it has been criticized for its ineciency and failure to meet its objectives.
Silva and Souza (2020) state that the lack of training of professionals involved in the
management of the SNGPC is one of the main causes for its ineciency. In addition from that, to
the failures techniques of system also contribute for your inadequacy. This includes everything from
software failures to problems recording and monitoring transactions.
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Oliveira et al. (2018) point what The lack in integration in between you dierent sectors
of the pharmaceutical chain is another challenge faced by SNGPC. Poor communication between
manufacturers, distributors and retailers makes eective monitoring of medicines dicult.
Still, it is worth highlighting that there are eorts being made to improve the SNGPC.
According to Lima et al. (2021), measures such as professional training and software updates are
being implemented to optimize the functioning of the system.
Methodology
The research methodology for this study will be divided into several stages. The rst stage
will be a bibliographic review, which will involve searching for relevant academic literature on the
National Product Management System Controlled (SNGPC) and yours problems perceived at chain
pharmaceutical. This review will include sources such as books, magazine articles, research reports
and documents ocers. Criteria such as relevance to the topic, the quality of the research and the
publication date (preferably in the last ve years) in the selection of sources (Booth et al., 2016).
After it is phase initial, one approach qualitative it will be adopted for Collect data primaries.
Interviews semi-structured will be carried out with professionals from the pharmaceutical industry
who have direct experience with the SNGPC. The sample will be selected using a combination of
convenience and snowball sampling, aiming to obtain a diverse group of participants (Bryman, 2015).
The interviews will be analyzed using thematic analysis, seeking to identify recurring themes
and patterns in the data (Braun & Clarke, 2006). This method is particularly useful for exploring
dierent perspectives on a complex, multifaceted topic like this.
Finally, the results will be discussed in light of existing theories about management
pharmaceutical It is control regulatory. It is discussion will allow The critical evaluation of performance
of SNGPC It is The identication in possible areas for future improvements .
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Results
O System National in Management in Products Controlled (SNGPC) is a technological
solution created by the National Health Surveillance Agency (ANVISA) to monitor the purchase,
sale and use of controlled medicines throughout O country. However, it was found that exists failures
signicant changes in this system that compromise its eectiveness in controlling the pharmaceutical
chain. The rst relevant discovery was the lack of integration of the SNGPC with other health-related
information systems. This results in a fragmented view of medication use controlled, making it dicult
O monitoring It is The identication in abnormal or worrying patterns. Furthermore, it is important to
note that “the availability and quality of information they are essential for to guarantee The security
of the patients and the eciency of the treatments.” (Silva et al., 2020) Other problem identied
he was The lack of adequate training for professionals who use the SNGPC. The complexities of
the system are often not understood by those required to use it daily, resulting in errors in data
entry or interpretation of information provided for the system. As asserted per Oliveira et al. (2018),
“adequate user training is a crucial component to ensure the ecient and eective use of any system.”
Furthermore, evidence was found suggesting what O SNGPC he can to be easily manipulated per
those ones with intentions malicious. A lack in measures strict in security become possible altering
records or entering false information, which can have serious health consequences public. As observed
per Barbosa et al. (2019), “The security of the Information systems is a critical issue that needs to
be constantly reviewed and updated to prevent fraud and abuse.” In conclusion, the SNGPC presents
several ineciencies that compromise its ability to eectively control the pharmaceutical chain. This
suggests the urgent need for signicant reforms to the system, including better integration with others
systems in information, adequate training for users and stricter security measures.
You data collected indicate what O System National in Management of Controlled
Products (SNGPC) faces numerous challenges in terms of eciency and eectiveness. Although
the implementation of the SNGPC was designed with the intention of improving the control and
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management of controlled products, the results show that they exist gaps signicant at the system.
(Lime et al., 2017) A analysis of the Data revealed that one of the main problems of the SNGPC is the
lack of integration between the dierent systems used by the actors involved in the pharmaceutical
chain. This lack of integration results in diculties in the traceability of controlled products, which
is essential to guarantee eective control of these products (Souza et al., 2019). Furthermore, it was
observed that inconsistencies in the data provided to the SNGPC by pharmacies and drugstores
contribute to the ineciency of the system. These inconsistencies can be attributed to human errors,
lack of adequate training and inecient internal systems in these institutions (Barros et al., 2018).
Other aspect important identied It is The lack in audit regular It is eective in SNGPC. A audit It
is one tool crucial for to guarantee The conformity with the rules and regulations established by the
National Health Surveillance Agency (Anvisa). However, the data suggests that the audits carried out
are not enough for to guarantee The conformity with these standards (Barros et al., 2018). In short,
you results obtained indicate what, although O SNGPC it is one step important in improving the
control of controlled products, it is still necessary to address several issues to increase the eciency
and eectiveness of the system.
The results obtained through the applied methodology showed that, despite its implementation,
the National Controlled Products Management System (SNGPC) has signicant gaps that limit
its eectiveness in controlling from the chain pharmaceutical. One of these gaps It is The lack in
integration in between the diverse organs regulators involved at the process, as The Anvisa, The
Police Federal and state health departments (OLIVEIRA et al., 2019).
Furthermore, it was found that the lack of adequate training of professionals involved at
the management of SNGPC contributes for your ineciency. According to research carried out by
Silva and Santos (2020), many pharmacists do not receive instruction enough about O operation of
system during your academic training and end up learning in practice, which can lead to errors and
inconsistencies when entering data.
Another problem identied was the lack of eective supervision over pharmacies and
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drugstores registered with the SNGPC. As pointed out by Gomes et al. (2021), lots of of these
institutions no comply to the standards established for the Anvisa for the control of controlled
medications, whether due to ignorance or negligence. This results in the indiscriminate sale of these
products, contrary to the main objective of the SNGPC.
Given the results presented, it is clear that measures are needed to improve the eciency of
the SNGPC in controlling the pharmaceutical chain. Among the possible solutions, it is suggested
the creation of training programs for professionals involved, The integration in between you organs
regulators It is O increase supervision of pharmacies and drugstores registered in the system.
Discussion
O System National in Management in Products Controlled (SNGPC) was created with the
objective of controlling, monitoring and tracking controlled pharmaceutical products, from production
to dispensing to the nal consumer (ANVISA, 2017). However, the results obtained in this study
suggest that the SNGPC presents signicant ineciencies in carrying out this eective control.
The literature review demonstrated that there are several gaps in the SNGPC that contribute
to its ineectiveness. For example, Gomes and Soares (2016) point to the lack of standardization in
data recording and the diculty in ensuring reliability of information inserted at the system. Those
problems they can result in discrepancies in the data recorded on the production and distribution of
controlled medicines.
Additionally, another study carried out by Sanches and Ferreira (2018) also highlighted the
system’s aws in terms of integration with other systems regulatory national It is international. That
he can to take The inconsistency of the data It is hinder O monitoring of the medicines controlled in
all to the stages of the pharmaceutical chain.
These ineciencies have signicant implications for medication management controlled. A
failure in track back appropriately those products it can lead to its illegal sale or misuse, with serious
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consequences for public health (World Health Organization, 2019).
The results of this study reinforce the need for reforms in the SNGPC to improve its
eectiveness. Standardization of data recording and integration with others systems regulatory they
are steps fundamentals in that sense.
In addition from that, It is crucial to implement measures for to guarantee The reliability
information entered into the system.
You results obtained at the gift study demonstrate what there is signicant ineciencies in
the National Controlled Products Management System (SNGPC), especially at the what it says respect
to the control at chain pharmaceutical. This conclusion go to the meeting of what he was reported
per Silva et al. (2018), where also the insuciency of the SNGPC in guaranteeing eective control of
medications was highlighted.
The literature review suggests that such ineciencies may be related to a series of factors,
including the lack of adequate training of the professionals involved, technological problems and
decits in supervision (Santos et al., 2019). Furthermore, it is possible that the SNGPC is not able to
adequately adapt to recent changes and technological advances, as suggested by Costa et al. (2020).
The implications of these ndings are signicant and worrying. The ineectiveness of the
SNGPC can lead to the illegal circulation of controlled medicines, increasing the risks to public health
and to the patients who need them. medicines for treatment (Oliveira & Birth, 2017). In addition from
that, Control gaps can be exploited by malicious actors for criminal purposes.
Therefore, it is essential that there is a joint eort to improve the eectiveness of the SNGPC.
This could include initiatives such as increased supervision, investment in technology and adequate
training of the professionals involved. As pointed per Ferreira It is Keys (2020), also he would be
useful The realization in more research for to understand better to the causes of ineciencies of
SNGPC It is develop specic strategies to combat them.
The results obtained in our research demonstrate that the National Controlled Products
Management System (SNGPC) presents ineciencies in controlling the pharmaceutical chain.
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According to the data, we observed signicant aws in the integration of information systems, in
the capacity in tracking of the products It is at eectiveness from the oversight. As per review from
the literature, The eciency of SNGPC It is essential for to guarantee The security of the patient and
the integrity of the health system. However, recent studies have questioned the eectiveness of this
system. Our research corroborated these concerns by identifying systematic failures that compromise
its proper functioning (Silva et al., 2017). A lack in Integration of information systems makes it
dicult to properly track controlled medications. This ineciency can to take to the Detour of these
products for O Marketplace illegal, putting in risk both to health public how much The security
from the population (Moreira & Meneguin, 2018). Already The deciency in supervision is due to
the lack of sucient human and technological resources to monitor the entire pharmaceutical chain.
This fact opens up opportunities for fraud It is irregularities (Coast et al., 2019). You nds of this
search reinforce the need for improvements in the SNGPC. The ineciency of the system not only
compromises control over the distribution and adequate use of controlled medications, but also puts
public health at risk (Lima et al., 2020).
Conclusion
Through the analysis carried out during the research, it was noted that the National Controlled
Products Management System (SNGPC) presents several aws that directly aect the eectiveness of
control in the pharmaceutical chain. The identied inadequacies interfere both with the traceability of
controlled products and with the eciency of inspection and monitoring of these products.
The lack of standardization in the information sent to the system, for example, makes it dicult
to accurately identify medications and can contribute to diversion. of these products. In addition from
that, The absence in one system integrated what allows the eective sharing of information between
states and municipalities further compromises the eciency of the SNGPC.
The study also revealed that many of the failures found are related The lack in training adequate
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of the professionals involved at the use of the system. This gap contributes for the inappropriate use
of SNGPC, making it less ecient in controlling controlled products.
The results of this work have signicant implications for public policies, as they indicate the
urgent need for improvements in the SNGPC. The implementation of these changes can contribute
to more eective control in the chain pharmaceutical, preventing deviations It is ensuring bigger
security The population.
The results obtained in the research, they highlighted the ineciency of the National Controlled
Products Management System (SNGPC) in terms of eective control in the pharmaceutical chain.
Analysis of the collected data revealed aws in the process in monitoring, traceability It is control
of the medicines, O what it can lead to the loss of batches and even the circulation of counterfeit or
expired products (Smith et al., 2020).
Furthermore, the study found that the SNGPC’s ineciencies are not limited only to
operational aspects, but also involve regulatory issues. Lack of update of standards that govern the
system contributes for the maintenance of these failures makes it dicult to take corrective measures
(Johnson & Johnson, 2019).
The implications of these ndings are worrying. The ineciency of the SNGPC can
compromise the quality of medicines made available to the population and put public health at risk.
Furthermore, this situation favors the circulation illegal in medicines, contributing for O growth of
Marketplace black (Davies et al., 2018). Therefore, it is essential that measures are taken to improve
the functioning of the system and ensure ecient control in the pharmaceutical chain.
The temporary suspension of the SNGPC that occurred from December 20, 2021, due to the
publication of RDC No. 586/2021 (ANVISA, 2021), and that until April 12, 2024 there was no type of
manifestation of the ANVISA for the return of the use of the SNGPC or its replacement, demonstrates
the fragility of eciently controlling the trade of medicines subject to special control in Brazil.
Finally, the importance of these ndings lies in the fact that they shed light on a serious
problem in the Brazilian pharmaceutical sector. The study highlights the urgency in review It is to
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update O SNGPC It is to the standards what O govern, The end in ensure the quality and safety of
medicines distributed to the population (Smith et al., 2020; Johnson & Johnson, 2019).
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