About the source of information

Having accepted the challenge of initiating AMC monitoring, the first task of national AMC surveillance teams is to choose reliable information sources from which data will be gathered. The different sources of information for AMC surveillance, such as import and/or manufacturing data, distribution data, drug prescription data in health services, dispensing records or the antimicrobials used by patients allow different levels of detail and disaggregation.

Although the sources of information closest to the patient in the pharmaceutical value chain provide the most reliable data, closest to reality, it is often more complex and expensive to be obtained. On the contrary, data sources that are further away from the patient, such as production, importation, distribution or purchasing data, although less precise due to the fact that not all manufactured/imported/ distributed/purchased medication is actually used, are more accessible and simpler to work with because the data is usually aggregated and consolidated.

On the other hand, and depending on the political configurations of countries, AMC data can be obtained from two different sectors: the public sector, which includes antimicrobials purchased by the government; and the private sector, comprising antimicrobials acquired by third parties.

Similarly, the data collected can also be determined by the level of care provided by the entities that acquire the antimicrobials: hospital (antimicrobials purchased and dispensed by hospital pharmacies to hospitalized patients) or community (antimicrobials bought and dispensed by community pharmacies). Likewise, data collection can encompass both levels or focus on a single level in the absence of data for the second level. Once more, the countries were able to choose among the three options: either disaggregate the data at the community or hospital level or maintain it as a whole if differentiation is not possible (total level).

Comparing the data sources included in this work among Latin-American & Caribbean countries, with other countries and regions, it could be said that heterogeneity is the common feature observed everywhere. For example, in the 29 countries (27 European Union (EU) Member States and two European Economic Area (EEA) countries – Iceland and Norway) ESAC-Network, results show that countries like Germany reported community level consumption, others like Cyprus reported overall consumption without discrimination, while the majority of the countries reported each level by separated files [22, Reference Ajulo and Awosile23].

The key point is the heterogeneity and complexity of each country’s national pharmaceutical markets and drug distribution systems that were used to assess antimicrobial consumption. In the Latin American and Caribbean countries that have conducted AMC assessments during the 2019–2022 period, various approaches were observed in obtaining consumption data, in terms of the sources used and the possibility of disaggregating the data by levels and sectors.

Countries may acquire antimicrobials from local production sources or may import them from other countries. The global data can be obtained by combining these sources. In this case, it may not be possible to break down consumption by sector (public or private) or level (outpatient or hospital), but there will be 100% coverage, encompassing the country’s total consumption. In Argentina and Colombia, drug manufacturing and import data were used, thus achieving 100% population coverage. Similarly, Barbados assessed AMC for the entire population (100%), using exclusively customs records for imports, as the country lacks local production of antimicrobials. If the antimicrobial distribution or purchasing information comes from the Ministries of Health that situation will exclusively represent consumption from the public sector. The representativeness of these data with respect to the national reality will depend on the country, its health system and the percentage of public sector coverage in relation to the total population. These sources may offer the possibility, eventually, of disaggregating consumption according to level, allowing the amount consumed at the hospital and outpatient level to be known. Countries such as Chile, Costa Rica, Cuba, Guyana, Honduras, Paraguay, Peru, Saint Kitts and Nevis, and Trinidad and Tobago used information on purchases, distribution or dispensing from the Ministry of Health or Social Security, corresponding only to the public sector, with variable coverage percentages. However, in most of these countries, the public or social security sectors represent the majority of the population (e.g., Cuba 100%, Costa Rica 97%, Peru 78%).

Another situation was observed in some countries, that faced difficulties in gathering information from all their geographical areas. The absence of centralized medication registries or bills, insufficient funding for travel and for obtaining copies or scanning of paper registries, the lack of internet access in remote areas and a shortage of human resources to collect the pertinent information became an obstacle to performing AMC surveillance. This was the situation faced by the national authorities of Guyana and Trinidad and Tobago that turned some of these limitations into challenges and decided to perform their evaluation in an escalated manner, starting with some regions of the country. In Guyana, consumption in Region 2 was analysed, while in Trinidad and Tobago, consumption was monitored through the Eastern Regional Health Authority (ERHA) [Reference Nagassar11]. These health teams not only succeeded in conducting the AMC assessment and reporting their own data but also managed to track four years of information in Guyana (2019–2022) and five in Trinidad and Tobago (2017–2021), analysing antimicrobial consumption behaviour before, during, and after the COVID-19 pandemic. Although it will be a future challenge for these countries to improve access to information sources for broader coverage, these initial assessments laid the groundwork for the methodology, provided valuable information, and allowed these countries to train skilled personnel for future evaluations.

An important aspect to highlight is that, although the improvement of information sources and data accessibility should be future goals in all countries, the majority have managed to develop or utilize their own sources. This advancement has allowed them to break free from dependence on commercial sources like IQVIA (formerly IMS Health), which was the only company available for evaluating AMC at a national level until a few years ago.

Despite the prestige of IQVIA and the quality of data that it provides, it is crucial to consider some aspects. To obtain information, the company makes estimations of volumes sold in retail pharmacies (community), and in certain countries, though not all, hospital pharmacies are also included. These estimations are derived from national sample surveys conducted at various points in the drug distribution channels, considered representative of each country (manufacturers, wholesalers, and/or distributors). Subsequently, using an algorithm developed by IQVIA, projections are made to obtain total sales volumes at the national level. Although it is known that this algorithm includes specific factors for each region and drug distribution channel, precise details and factors are not disclosed due to the company’s exclusive ownership [Reference Van Boeckel13]. Therefore, this method of information collection determines that the origin of the data and population coverage varies from country to country, not allowing comparisons between them. Additionally, IQVIA does not provide a defined population number that can be used as a denominator when calculating consumption, and determining this number is often a complicated task.

The use of own sources not only avoids costs associated with information acquisition but also allows for better contextualization of the data, providing greater precision regarding the population using monitored antimicrobials and a more detailed understanding of the data’s origin. This, in turn, results in a more robust analysis of consumption data.

About applying the WHO data collection instrument

The WHO-GLASS has developed an instrument for collecting AMC data, implemented since 2017 in different countries around the world. It consists of an Excel spreadsheet with associated macro functions, which allow the automatic calculation of consumption for each individual antimicrobial, according to the route of administration [9].

Once the information is uploaded, the tool validates the entered data, calculates the consumption in DDD and DID for each antimicrobial individually according to the route of administration, and exports the results of these calculations to a new workbook. It also enables the generation of an additional file for data export to the GLASS system.

During the validation process, if the tool system detects inconsistencies in the information entered in the three work tabs or certain errors in product load, the software identifies them and reports them as a “bug.”

This instrument is updated annually by the WHO, considering any modifications or new additions to ATC and DDD codes that may have occurred, in accordance with the provisions of the WHO Collaborating Centre for Drug Statistics Methodology in Oslo, the centre responsible for the development and update of the ATC/DDD system [17].

Although many countries in the Region have adopted the GLASS-AMC methodology, they used the tool for their AMC data collection at the local level.

Some other countries have implemented their own data collection systems. For instance, Mexico developed its own tool, designed to calculate the necessary annual antimicrobial purchases. Although the instrument effectively fulfils its original purpose, which is the calculation of the annual demand of antimicrobials in order to foresee the purchase that the country will need for the next period; the instrument does not adjust antimicrobial consumption based on population used, avoiding this way the possibility to obtain the DID. Hence, this tool does not allow AMC comparison between different regions of the country or other countries neither to track consumption over the years.

Similarly, Argentina has also developed its data collection instrument, supported by the European Union fund, which has the possibility of calculating AMC. However, this tool does not allow the export of data to GLASS. To do this, it is necessary to migrate the data to the WHO AMC Template.

Another noteworthy initiative regarding the publication of information related to the use of antimicrobials is the case of Chile. Through the CENABAST (Central Supply of the National Health Services System) website, via its observatory, it is possible to publicly access all purchases of antimicrobials made [15].

Currently, Colombia and Peru share their antimicrobial consumption surveillance data through the GLASS-AMC platform, and the information can be visualized online using the GLASS Dashboard [7]. Honduras has recently signed the compromise to report to the GLASS Dashboard. It is interesting to analyse why even when the countries have their own reports in the GLASS tool, they do not make the commitment to report periodically to the GLASS platform. From this experience, we have detected that although countries’ referents make the effort to collect AMC information, they have a certain reluctance to establish further commitments that they are not sure of being able to fulfil in the future. Likewise, some representatives have expressed that the data obtained is useful for decision-making at a local level and they do not see the advantages of sharing their data at a global level. In this sense, it should be noted that there are countries in which CUFAR and PAHO teams have collaborated and obtained information on AMC at the national level, but nevertheless, they have decided not to communicate their data, an aspect that our team respects and accepts since the first objective of this AMC survey takes local measures aimed at the best use of antimicrobials and the reduction of AMR. However, it is very important to understand that AMR is a global problem, and therefore, we must not face it in isolation. We must understand that knowing AMC in each country has positive externalities for other nations, and therefore, reporting to GLASS-WHO is a way to face this problem together. For this reason, we will continue to take measures in order to show the responsible in each country that sharing its own data does not have a punitive or critical meaning, but rather can be useful to correct and jointly confront the AMR problem.

About the process of training local teams on national AMC data collection

A crucial step in the national AMC assessment is the formation and training of a local team to identify the best source of information, upload collected data into the WHO AMC Template, and perform subsequent data analysis.

In each Latin American and Caribbean country that carried out their national AMC assessments, key persons named “focal points” were identified. These are individuals or work teams with a specific interest in the containment of AMR and, in particular, the methodology for evaluating AMC. After being identified, these focal points expressed their willingness to receive training.

The training was carried out through a course available on the PAHO Virtual Campus for Public Health (VCPH), “Online training on the WHO methodology for antimicrobial consumption surveillance” [12]. The course, in a self-administered format, allows the participants to access the material at any time of the day, advance through the content at their own pace, and have tutoring provided by CUFAR.

Besides the online resource, the CUFAR team provided training support and technical cooperation to the countries through virtual workshops, at the request of the PAHO national AMC-AMR focal points. Additionally, it offered individualized tutoring and assistance to the national teams to resolve questions, detect errors in data entry, and find solutions to possible obstacles in the AMC implementation process, through virtual or in-person meetings, email, and/or instant messaging. Although it is a task that requires time and dedication, the personalized support online or on-site, together with the person responsible for loading the data into the GLASS instrument, has been highly effective and allowed us to leave installed capacity in each country.

About the most common errors detected during data collection

Analysing AMC using the WHO methodology and the tool designed for this purpose is not overly complex, but it is by no means a routine task; especially when the tool is used for the first time.

The calculation of national AMC, using total local antimicrobial production plus imports as a source of information, may involve the loading of among 250 to 1,300 different products containing one or more antimicrobials when performing the task for the first time, depending on the country. In the case where the source of information is purchases, distribution, or dispensing data from the public sector, the number of products to be loaded is a little smaller, ranging between 40 and 150. In any case, handling these volumes of information increases the probability of slip-up during the loading process.

In subsequent years, the uploading process becomes easier as not all products need to be reloaded. Instead, it suffices to enter the number of packages consumed for the new year. At this point, the difficulty of the task lies in precisely identifying the products that were not used in this new year and the new products that may have been added. The latter must be loaded into the WHO AMC Template at that time.

Based on the experience obtained with the countries of Latin America and the Caribbean, it was observed that frequent difficulties were related to data loading in the WHO tool and resolving bugs that appeared when executing the macro functions [17, Reference Nation21].

In 60% of the countries, incomplete or erroneous product descriptions (“label”) were identified. These situations were linked, in some cases, to a lack of information or errors in the data sources, and in other cases, to omissions or mistakes when loading information into the WHO AMC Template. An inaccurate or incomplete description can lead to errors in variable input and, consequently, in consumption calculations. As an example, during the entry of “tobramycin 28 mg capsules,” it was mistakenly assumed to be an oral administration formulation and was entered as such when, in reality, it was a formulation for inhalation (powder capsules for inhalation).

About the quality control stage

The WHO AMC Template, through its associated macro functions, facilitates a first automatic validation to identify certain errors in data loading. This validation can detect empty cells inadvertently omitted when loading information, or data entered inconsistently with the corresponding column, such as the introduction of alphabetical values in columns that only accept numbers, or codes that do not comply with the methodology (for example, to account for tablets or vials, the code “pcs” for “pieces” must be entered; if the word “pieces,” “tablets” or “vials” is entered, the macro will indicate an error).

Although this initial automatic validation is useful, it does not allow the detection of other common loading errors, as mentioned in the previous section. For instance, if an additional zero or one is mistakenly entered when loading the concentration of a product, the macro will not detect it, leading to an overestimation or underestimation of consumption. To avoid these inconveniences, which can later translate into calculation errors, once the data is loaded into the WHO AMC Template, the countries had the option to share them with the CUFAR team for validation and quality control. Upon receiving the information, an initial manual verification process was carried out in order to identify loading errors not detected by the automatic validation of the macro. Once these errors were identified and analysed, suggestions were provided to the national AMC team, who reviewed and corrected the data load. In this way, with these exchanges, a double objective was achieved: a precise load, without errors, and the strengthening of the technical knowledge necessary to apply the methodology. Once all the data are loaded and validated, the AMC is calculated, and the analysis of the information is performed. This stage represented another critical opportunity to identify potential anomalies. Here, errors arose not only linked to the data loading itself but, for example, to the original information sources used to obtain the data. These errors manifested as excessively small or large DID, or as unjustified jumps in consumption within an expected pattern, especially when there were already some years evaluated.

The data validation and quality control stage turned out to be crucial. Difficulties and errors were identified in all countries, which could be corrected at this time, allowing a more precise calculation of consumption that is closer to reality.

Current limitations and future challenges in the national evaluation of AMC

As important as it is to highlight the progress achieved in terms of the implementation of national AMC surveillance in the Latin America and Caribbean Regions, it is also important to understand the limitations and challenges encountered. Recognizing that there is still a long way to go prompts us to reflect on building new strategies that allow us to obtain more accurate data, achieve broader data coverage, and have better-trained personnel in data entry while speeding up the process and minimizing errors. By obtaining more accurate and global data, countries will have more tools to make better-informed decisions, develop more effective policies, and achieve better public health results regarding AMR containment.

The variation in the results obtained in this study is explained, at least in part, due to the heterogeneity of the information sources used by different countries. These sources are extremely useful for temporal monitoring within the same country and understanding consumption trends in the evaluated sectors. However, precisely because of their heterogeneity, they do not provide the possibility of making reliable comparisons between countries or reaching regional conclusions with certainty.

Although the difficulties in accessing information sources vary considerably between different countries, possibly due to their diverse realities, it is relevant to mention some identified common obstacles.

To date, only Argentina, Barbados, and Colombia have managed to evaluate global consumption with 100% population coverage. In other countries, although some included a population percentage close to 100%, it is still not possible to access global data. In Argentina and Colombia, regulations require that laboratories report all antimicrobials produced, imported, or distributed, along with the corresponding quantity. Considering the possibility of improving access to information sources, a potential solution could be the implementation of specific legislation in this regard.

To assess global AMC with 100% coverage, data from the private sector is required. Therefore, it will be necessary to find ways to access this data, either through cooperation agreements or the implementation of regulations that mandate the mandatory reporting of production, importation, distribution, or sales by this sector.

At this point, it is also relevant to note that consolidated databases may not always exist, and it may be necessary to develop them. Argentina and Colombia have successfully addressed this challenge by building their own information databases to collect the necessary data for AMC analysis.

In the case of Argentina, the National Administration of Drugs, Food, and Medical Technology (ANMAT) has implemented that all laboratories producing and importing antimicrobials in the country have to annually report their production/importation through a sworn statement process, since 2016. From these individual notifications, ANMAT “builds” the necessary database.

In Colombia, the national team uses two different sources of information, which, when combined, provide all the necessary data for AMC surveillance. These sources are the Sanitary Registrations from the National Institute of Surveillance of Medicines and Food (INVIMA) and the Drug Price Information System (SISMED), through which laboratories must report to the Ministry of Health all drugs sold and their prices, whether domestically manufactured or imported.

For nations using information sources from the public sector, one of the future challenges should be obtaining data from the private sector to achieve a comprehensive assessment of global AMC. Despite the extensive population coverage provided by the public sector and social security in many countries in Latin America and the Caribbean, it is crucial to take into account the private sector to understand its consumption profile. Furthermore, factors such as long distances to public health centres or prolonged waiting times may lead individuals to seek private sector consultation. Another situation that could impact global consumption to varying degrees depending on the country, and not considered when relying solely on public sector sources, is the purchase of antimicrobials without a prescription. On the other hand, the sources used by most countries reflect AMC at the national level without the possibility of disaggregating consumption by states, provinces, regions or zones. This limitation prevents a precise correlation with local realities, which may not always coincide with the country’s overall situation. Evaluating consumption solely at the national level without taking into account regional differences may, for example, mask consumption increases in certain areas if consumption declines in neighbouring regions. It will also be important in the future to obtain disaggregated information regarding the level of care to understand different consumption profiles at the outpatient and hospital levels. So far, only Nevis and Trinidad and Tobago have been able to differentiate consumption by level.

Ultimately, for regional harmonization, there is a need to have unified national databases that systematically group all AMC information to assess global consumption. However, at the same time, it will be necessary to establish mechanisms that allow for the disaggregation of that information by sectors, levels of care, and zones. Accessing global consumption data on one hand and minimum levels of information sources on the other will enable the acquisition of more reliable and robust consumption data, with greater comparability, whether between different zones or different sectors of the healthcare system within the same country or across different countries. All of this will lead to a better interpretation and contextualization of the data.

Another aspect related to information sources, which mainly impacts the countries of the Caribbean Region, is the existence of data in physical format and its lack of consolidation, representing significant obstacles, making access to information difficult or unfeasible due to the magnitude of the work required. Digitization becomes imperative and essential to be able to handle large volumes of information efficiently. Likewise, in relation to the limitations of access to technology, in certain areas of this Region, poor Internet connection can constitute an obstacle, making it difficult, for example, to make video calls that are essential for training and the exchange of experiences, as well as access to training material.

In relation to the formation and training of national teams, a frequent limitation is the lack of “protected time” to learn methodological issues and to carry out the necessary technical training, perform data loading, and conduct the review and the analysis of the information. This is possibly a consequence of the scarcity of human and/or financial resources allocated to the AMR containment, and specifically, to the evaluation of AMC.

Furthermore, it is important to remark that in many countries, work teams have not been formed, and a single person has assumed the responsibility of uploading, verifying, and analysing the data. This can hinder the medium- and long-term continuity of AMC evaluations, due to the turnover or replacement of already trained personnel, generally linked to changes in political-health management. Additionally, working in a team could allow, for instance, one person to input data into the WHO AMC Template while another conducts a critical and thorough verification, which could be beneficial in decreasing errors and slip-ups, and ensuring data quality.

A final discussion of the work performed

Although international experiences offer valuable lessons, they are seldom entirely transferable to the internal reality of each country [Reference Frost24]. Our experience reflects the heterogeneity of the realities that are evident in the different countries of Latin America and the Caribbean. It will be essential for those countries aspiring to implement national monitoring of AMC to consider the specific situation of their own territory, with all its peculiarities in identifying the appropriate sources of information and the sector and level of data that will be obtained. These elements are crucial for the periodical monitoring and follow-up of the AMC, considering that this information will be essential for the decision-making in health policies at the national level. Even though the conditions may not be ideal, taking the first step in AMC registration is important, even if it seems small, as it will allow for the accumulation of experience. Ultimately, the path is made by walking.