Washington, DC., November 2022. With the entry into force of the Law on Medicines, published in Official Gazette Volume 394 on 2 March 2012, the restructuring of health regulations on medicines and other products in El Salvador began. The National Directorate of Medicines (DNM) was created, with a priority at that time, to regulate the price of prescription medicines and monitor their rational use.
Over time, antimicrobial resistance became an increasingly serious threat to global public health.Thus, in 2014, El Salvador decided to regulate the sale and dispensing of these medicines through public policies and develop different strategies to inform the population. The DNM promoted control of the sale of these products in regulated pharmaceutical establishments through the following actions:
- Discussion with key stakeholders:
- Pharmaceutical laboratories
- Establishments that sell medicines
- Pharmaceutical and medical associations
- Outreach to media editors to put the importance of antimicrobial control on their agendas.
- Communication on inspection activities to the pharmacies.
- Press management for media coverage on issues related to control measures.
- Dissemination of informational materials on the control of the sale of antimicrobials.
"The National Directorate of Medicines is focused on giving a single message: Taking antibiotics without medical supervision puts your health at risk. Take them only when prescribed by a doctor. In 2022 we have had an ongoing educational campaign, complemented with permanent health surveillance", noted Noe García Iraheta, National Director of Medicines.
The experience of implementing the regulations
The process began by informing the population about the new provisions. . As of June 2015, pharmacies were provided with official material restricting the dispensing of injectable antimicrobials with prescription only. . Pharmacies were also notified of the need to put in place the necessary measures to trace the sale of the injectable antimicrobials they dispensed and match that against their physical inventory. This resulted in the prohibition of the sale and dispensing of injectable antimicrobials without a prescription to the general public. As a result of these steps, the consumption of injectable antimicrobials decreased by 25% in one month.
Figure 1. Sales volume index of injectable antimicrobials after implementation of regulations on their sale in pharmacies in El Salvador, starting 1 June 2015.
In 2018, the DNM began phase two of the control plan in order to monitor the rational use of antimicrobials. As an enforcement measure, consumers were required to present a prescription signed by an authorized professional to purchase the following antimicrobials, regardless of the route of administration: cefixime, azithromycin, clarithromycin, levofloxacin, moxifloxacin, and norfloxacin.
To monitor implementation of this measure, the inspection plan included a specific section on controlling injectable antimicrobials and those included in the second phase of the control plan. Inspections were conducted in 90% of DNM-licensed pharmacies.
Development of a strategic plan to standardize the technical requirements for pharmacy inspections implementation
To continuously improve its actions and procedures for controlling the sale of antimicrobials in the country, the DNM participates in regular meetings organized by the Pan American Health Organization (PAHO). These forums lead to specific action plans that take into account components such as political support, coordination of actors, review/updating of regulations, inspections, sanctions, financing, and monitoring, among others.
As part of technical cooperation, El Salvador moved forward in the development of a strategic plan to standardize the technical requirements for pharmacy inspections. In November 2021, the first pilot plan was launched to control antimicrobials included in the World Health Organization’s AWaRe classification. This pilot uses a checklist consolidated by countries of the Region with experience in antimicrobial control (Cuba, Colombia, Mexico, and Paraguay) along with PAHO support. The plan seeks to assess the dispensing in a total of 20 public and private pharmacies in El Salvador.
Given the need for a national legal framework to implement technical requirements, updated regulations on good storage and dispensing practices applicable to DNM-regulated pharmaceutical establishments were published in June 2022 in Official Gazette No. 118, Vol. 435. The regulations include the control of antibiotics, thus providing greater regulatory power to control the dispensing of these medicines.
Communication Campaigns
The DNM’s next steps, in the short and medium term, include communication campaigns to raise awareness about the rational use of antimicrobials through the different official information platforms, as well as pharmacy inspections and surveillance of unauthorized facilities, to prevent the sale of these medicines.
*Photo: The photo corresponds to the album “Prevención del Zika en los controles de embarazo en El Salvador”. It was taken in 2016. © Pan American Health Organization.
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 Ventura, El Salvador´s National Directorate of Medicines, to PAHO/WHO for the Bulletin on Rational Use for of antimicrobials for the containment of the resistance.