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Volume 16 - Issue 6 - December 2022

Contents

Page 7 of 7

Report from the Field

  • COVID-19 Vaccines and Roles of the Health Regulatory Authority in Tunisia

  • Nour Chtiba, Dora Cherif, Imène Mersni, Meriem Kadri, Aroua Jemei, Imed Lassoued, Myriam Razgallah Khrouf
  • Published online by Cambridge University Press:
    28 July 2022, pp. 2694-2696

  • Given the unstoppable spread of coronavirus disease (COVID-19), the development of a vaccine was needed to contain the pandemic. In such a situation of global emergency, regulatory authorities ensured timely, safe, and equitable access to the vaccine.

    This article aims to outline the roles of the Tunisian regulatory authority, the Directorate of Pharmacy and Medicines (DPM) at the Ministry of Health, in registration and procurement of the COVID-19 vaccine.

    Requirement to grant the Exceptional Provisional Authorizations of Marketing (EPAM) for COVID-19 vaccines was 27 days versus 869 days for conventional marketing authorizations (MAs). The DPM has optimized its activity through: early dialogue with manufacturers, online submission, the use of distance communication technologies. It has demonstrated unprecedented flexibility through the continuous and rolling review approach.

    Regulatory authorities in Tunisia and around the world have partnered with manufacturers to speed up administrative procedures while ensuring the quality, safety, and efficacy of vaccines.

Addendum

Corrigendum

Retraction

Original Research

  • RETRACTED–Assessing Hospital Adaptive Resource Allocation Strategies in Responding to Mass Casualty Incidents

  • Roberto Faccincani, Paolo Trucco, Claudio Nocetti, Michele Carlucci, Eric S. Weinstein
  • Published online by Cambridge University Press:
    11 June 2021, pp. 2700-2708
  • Background:

    Hospitals are expected to operate at a high performance level even under exceptional conditions of peak demand and resource disruptions. This understanding is not mature yet and there are wide areas of possible improvement. In particular, the fast mobilization and reconfiguration of resources frequently result into the severe disruption of elective activities, worsening the quality of care. This becomes particularly evident during the on-going coronavirus disease 2019 (COVID-19) pandemic. More resilient resource allocation strategies, that is, which adapt to the dynamics of the prevailing circumstance, are needed to maximize the effectiveness of health-care delivery. In this study, a simulation approach was adopted to assess and compare different hospital’s adaptive resource allocation strategies in responding to a sudden onset disaster mass casualty incident (MCI).

    Methods:

    A specific set of performance metrics was developed to take into consideration multiple objectives and priorities and holistically assess the effectiveness of health-care delivery when coping with an MCI event. Discrete event simulation (DES) and system dynamics (SD) were used to model the key hospital processes and the MCI plan.

    Results:

    In the daytime scenario, during the recovery phase of the disaster, a gradual disengagement of resources from the emergency department (ED) to restart ordinary activities in operating rooms and wards returned the best performance. In the night scenario, the absorption capacity of the ED was evaluated by identifying the current bottleneck and assessment of the benefit of different resource mobilization strategies.

    Conclusions:

    The present study offers a robust approach, effective strategies and new insights to design more resilient plans to cope with MCIs. It becomes particularly relevant when considering the risk of indirect damage of emergencies, where all the available resources are shifted from the care of the ordinary to the “disaster” patients, like during the on-going COVID-19 pandemic. Future research is needed to widen the scope of the analysis and take into consideration additional resilience capacities such as operational coordination mechanisms among multiple hospitals in the same geographic area.

Page 7 of 7