In 2018, Colombia’s Ministry of Health and Social Protection led the development of the country’s National Antimicrobial Resistance Response Plan (National AMR Plan) (1). In coordination with the public agriculture sector and with adaptations to the national context, the plan implemented the five strategic lines of the World Health Organization’s 2015 Global Action Plan on Antimicrobial Resistance: 1) improve awareness and understanding of antimicrobial resistance; 2) strengthen the knowledge and evidence base through surveillance and research; 3) reduce the incidence of infection; 4) optimize the use of antimicrobial medicines; and 5) develop the economic case for sustainable investment.
With regard to the dispensing of antimicrobials, the National AMR Plan establishes regulations, from the time antibiotics are registered, that classify them as medicines that require a medical prescription (Decree 677 of 1995)(2). Regulations also establish that the dispenser should require the medical prescription when the medicine is labeled “sale by prescription” and confirm that the prescription has been prepared by qualified health workers and that it complies with the characteristics and contents of prescriptions cited in the regulations. (Decree 780 of 2016, Art. 2.5.3.10.18) (3).
The National AMR Plan recognizes that compliance with these regulations is limited. According to a study conducted in the city of Bogotá, 56% of the population had used antibiotics without a medical prescription at some time, while 44% of those who purchased antibiotics in selected pharmacies did so without a prescription. It is recognized that these problems may be worse in remote regions (1).
Development of proposed regulations for enforcement procedures
In this context, the Ministry of Health and Social Protection is developing proposed regulations to address the main constraints on the control of prescription antibiotic sales. The proposal is aimed at establishing guidelines for the proper use of antibiotics and includes specific guidelines for antibiotic sales. The goal is that through adoption of the WHO AWaRe classification (4)––which categorizes antibiotics into access, watch, and reserve groups––retail sales of reserve-group antibiotics will be explicitly prohibited in retail pharmaceutical establishments and will only be allowed in hospitals, hospital pharmacy services, and wholesale establishments that supply antibiotics to hospitals.
The proposed regulations clarify the types of pharmaceutical establishments authorized to sell prescription antibiotics. They also require that invoices for antibiotic purchases from wholesale dealers, as well as the original medical prescriptions for public sales, must be saved for a specified time. It is necessary to implement a system to track incoming and outgoing inventory and dispatched prescriptions in order to facilitate monitoring through inspections by the appropriate local authorities. Furthermore, the proposed regulations clarify which authorities are in charge of inspection and monitoring and they establish sanctions for violations, considering that the current regulations do not mention these aspects. Sanctions must be compatible with those set forth in the national regulations (Law 9 of 1979) (5). Depending on the severity of violation found by the authorities in charge of monitoring, sanctions may include warnings, a series of fines, seizures of products, suspension or cancellation of operating licenses, and/or temporary or permanent closures of facilities.
A variety of technical areas within the Ministry of Health and the National Institute of Drug and Food Monitoring (INVIMA, the regulatory agency) have supported and participated in development of the proposal. However, a thorough discussion process is still needed with local authorities, pharmaceutical establishments, and other stakeholders in the regulations. Due to the difficulties of organizing a meeting of the various actors because of the COVID-19 pandemic and considering the need to prioritize the response to this situation, the timetable for the regulatory process has been delayed.
Health education campaign in mass media and social media
While the greatest difficulty in enforcing regulations on the sale of prescription antibiotics is when they are dispensed, the AMR plan recognizes that there is also a related problem of public demand for unprescribed antibiotics. This is due to a lack of knowledge about the implications of this behavior with regard to antibiotic resistance. Accordingly, the Ministry has conducted educational campaigns in the mass media and social networks to improve understanding of AMR and raise awareness about how the community can help prevent it. As part of this initiative, the Ministry of Health launched a commercial entitled “A vital contract: no antibiotics without a medical prescription” on 3 March 2020. The key message is for people not to use unprescribed antibiotics against the common cold and general pain in order to help ensure that bacteria do not stop responding to antibiotics when they are needed. (available at: https://www.facebook.com/177016012461505/videos/142258413685557)
Identified challenges to this communication strategy include the difficulty in measuring its direct impact on the target audience in terms of behavioral changes affecting the purchase of prescription antibiotics. Another significant challenge is to ensure the availability of resources to maintain public educational campaigns on this subject, considering the priority given to communication on the COVID-19 pandemic health emergency.
Disclaimer
Authors hold sole responsibility for the views expressed in their texts, which may not necessarily reflect the opinion or policy of the Pan American Health Organization. The mention of specific companies or certain manufacturers' products does not imply that they are endorsed or recommended in preference to other ones of a similar nature.
Note: Article subscribed by Laura Angelica Pineda Velandia, pharmaceutical chemistry, Colombia´s Ministry of Health and Social Protection, Medicines and Health Technologies, to PAHO/WHO for the Bulletin on Rational Use for of antimicrobials for the containment of the resistance.
References
- Ministry of Health and Social Protection. PLAN NACIONAL DE RESPUESTA A LOS ANTIMICROBIANOS. 2018 Available at: https://www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/RIDE/VS/MET/plan-respuesta-resistencia-antimicrobianos.pdf
- Office of the President of the Republic of Colombia. Decreto 677 de 1995, “Por el cual se reglamenta parcialmente el Régimen de Registros y Licencias, el Control de Calidad, así como el Régimen de Vigilancia Sanitaria de Medicamentos, Cosméticos, Preparaciones Farmacéuticas a base de Recursos Naturales, Productos de Aseo, Higiene y Limpieza y otros productos de uso doméstico y se dictan otras disposiciones sobre la materia”. Available at: https://www.invima.gov.co/documents/20143/453029/decreto_677_1995.pdf
- Ministry of Health and Social Protection. Decreto 780 de 2016. Por medio del cual se expide el Decreto Único Reglamentario del Sector Salud y Protección Social. Available at: https://www.minsalud.gov.co/Normatividad_Nuevo/Decreto%200780%20de%202016.pdf
- World Health Organization. WHO releases the 2019 AWaRe Classification Antibiotics. Available at: https://www.who.int/medicines/news/2019/WHO_releases2019AWaRe_classification_antibiotics/en/
- Congress of the Republic of Colombia. Ley 9 de 1979. Por la cual se dictan Medidas Sanitarias. Available at: https://www.funcionpublica.gov.co/eva/gestornormativo/norma_pdf.php?i=1177