Abstract
In view of the possible disruptions in the manufacturing and supply of health products following the coronavirus disease 2019 (COVID-19) pandemic, the Tunisian medicines regulatory authority was mobilized to guarantee patient safety. Teleworking has become the ultimate way of service continuity. The planning was revised according to health priorities. Work procedures were set online. A minimum list of medicines known as "medicines of health and strategic interest" was established. The Directorate of Pharmacy and Medicines (DPM) has been working on updating medicines stock data. A provisional suspension of authorizations for medicines export for 1 mo was decided. A fast-track procedure allowing the validation of alternative sources of raw materials has been put in place. An appeal for a fast track manufacture of hydroalcoholic gel/solutions was launched. A Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI) procedure has been adopted in order to dispense off-label prescriptions of hydroxychloroquine and azithromycin combination. Focus groups were organized in order to set up therapeutic trials exploring possible strategies of COVID-19 treatment, such as serotherapy and BCG vaccine. This proactive and anticipatory policy has made it possible to meet the health challenges dictated by this crisis.
Highlights
In view of the possible disruptions in the manufacturing of health products and supply shortages following the COVID-19 pandemic, the Tunisian medicines regulatory authority was mobilized to ensure the availability of medicines and medical devices and to guarantee patient safety
The Tunisian pharmaceutical laboratories were informed by means of a press release from Directorate of Pharmacy and Medicines (DPM) of the provisional suspension of authorizations for medicines export for 1 mo, renewable according to the health situation evolution in the country
Regulatory authorities faced a real challenge during the COVID-19 pandemic to ensure patient safety in a health emergency
Summary
The coronavirus disease 2019 (COVID-19) pandemic is an unprecedented health, economic, and social crisis.[1,2,3,4,5] In view of the possible disruptions in the manufacturing of health products and supply shortages following the COVID-19 pandemic, the Tunisian medicines regulatory authority was mobilized to ensure the availability of medicines and medical devices and to guarantee patient safety. During the period of general containment decreed in Tunisia in early March, DPM and LNCM had to ensure services continuity and react to this public health emergency. Confronted with this unprecedented situation, an active collaboration between the Ministry of Health’s compute center (CIMS), DPM, and LNCM was urgently established to put in place logistical means for a new organization of work.
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