Washington, DC., August 2020. The fight against antimicrobial resistance has led to several initiatives by the Ministry of Public Health and Social Welfare of the Republic of Paraguay, through the National Health Surveillance Directorate (Dirección Nacional de Vigilancia Sanitaria DNVS). Activities are underway to address the different lines of action proposed by the Pan American Health Organization/World Health Organization (PAHO/WHO) in the context of the Global Action Plan on Antimicrobial Resistance.
Various activities were planned on this issue during virtual meetings held in August 2018, and commitments were made. Afterwards, a face-to-face meeting attended by representatives of several countries was held in Bogota, Colombia, to outline a work plan on monitoring the sale of antimicrobials.
The following important factors were identified for the implementation of an effective and sustainable enforcement process: political will, coordination among actors, review of standards and procedures, inspections, sanctions, funding, monitoring, a pilot implementation phase, and an awareness campaign. Indicators were also assigned to these factors, including responsible parties, implementation times, expected results, activities involved, related responsible parties, resources required, feasibility, and others.
Political will was identified as the main factor needed for this project. Paraguay gave an immediate response, providing increased support for the work being done on the issue. Through swift action, the provisions of the Colombia meeting were almost entirely met within the prescribed deadlines.
Accordingly, regulations were adopted on the sale of systemic antibiotics with a simple archived prescription. Ministerial Resolution S.G. No. 576/18 and extended Resolution S.G. No. 608/18, require a simple archived prescription for the sale of systemic antibiotics. At the same time, Ministerial Resolution S.G. No. 596/18 and the extended Resolution S.G. No. 035/19 took effect, establishing a national technical committee to develop the National Plan to Combat Antimicrobial Resistance (Plan Nacional contra la Resistencia Antimicrobiana). On 4 April 2019, Ministerial Resolution S.G. No. 163/19 approved the National Plan to Combat Antimicrobial Resistance in Paraguay 2019/2023, providing for "IMPLEMENTATION AND APPLICATION IN ALL NATIONAL TERRITORY".
The national plan is based on five strategic lines. Enforcement actions to ensure archived prescription sales is included in the fourth strategic line: Optimize the use of antimicrobial medicines in human and animal health. Implementation of regulations.
Implementation of regulations
Some challenges arose after implementing regulations requiring a simple archived prescription for the sale of antibiotics. Several sectors were not receptive to the measure, including prescribers, dispensers, manufacturers, importers, and the general population.
Actions that accompanied implementation of the new condition of sale for these medicines included information sessions, notices issued to medical societies, and social media posts. The expected impact was not produced. However, radio, television, and print media communicated the conditions of the new regulation.
Enforcement procedures are carried out through verification of compliance with current regulations. Data were obtained on compliance with prescription requirements for dispensing antibiotics, and audits of sales records in pharmacies. Pharmacies committing violations are referred to DNVS legal counsel for action, according to the corresponding procedure.
To date, the biggest obstacle to implementing this restriction on the condition of sale of antibiotics is improper prescribing, for example, not meeting all prescription requirements. This impacts people's experience when purchasing medicines.
Considering the circumstances, initial enforcement planning has moved from the project stage to fieldwork, without a pilot phase. Obstacles for performing compliance checks include staff shortages and available means to increase controls. Existing regulations also must be adjusted or expanded in order to improve enforcement over the marketing of antibiotics.
The Technical Committee is working with the appropriate institutions on a permanent awareness campaign to inform the target population about the issue.
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Note: Article subscribed by por José María Cardozo Baruja, National Agency for Health Surveillance to PAHO/WHO for the Bulletin on Rational Use for of antimicrobials for the containment of the resistance.