Piano Strategico-Operativo Nazionale Di Preparazione E Risposta A Una Pandemia Influenzale (PanFlu) 2021-2023

Objectives

Italy’s 2021–2023 national influenza pandemic plan provides a strategic-operational framework for preparedness, response, recovery and return to the inter-pandemic phase. It aims to strengthen national and local readiness, protect the population, reduce cases and deaths, safeguard health and emergency workers, preserve essential health and social services, and limit disruption to social and economic life.[1][2]The framework is designed principally for influenza pandemics but retains adaptable elements for other highly transmissible respiratory pathogens, including a potential “pathogen X”.[3][4][5]

• Establish national, regional and local roles, harmonised regional planning tools, continuous training, monitoring and periodic plan updating.[2]
• Strengthen prevention, rapid identification, epidemiological and virological surveillance, risk assessment, diagnosis, patient care and treatment while reducing infection risks for health workers and the public.[6][7][8]
• Organise action across inter-pandemic, alert, pandemic and transition phases, adapting measures to national and sub-national risk, severity, epidemiological evidence and health-service pressure.[9][10][11]
• Maintain resilient territorial and hospital services, including capacity for home care, emergency transfers, continuity of essential services, intensive-care expansion and management of vulnerable groups.[12][13][14]
• Embed infection prevention and control, non-pharmaceutical interventions, vaccination, antivirals, strategic supplies, personal protective equipment and essential medical devices within preparedness and response.[15][16][17][18]
• Promote equity, non-discrimination, proportionality, social responsibility and protection of vulnerable people in public-health decisions and clinical resource allocation.[19][20][21]
• Support recovery through restoration of health and other essential services, community support and structured learning from In-Action Reviews and After-Action Reviews.[22][23]

Implementation

Implementation uses a cyclical preparedness model of planning, exercising, monitoring, evaluation, revision and post-event learning.[24][1][25]The Ministry of Health provides national policy direction, coordinates regional preparedness, verifies regional operational capacity and leads collaboration with the Regions and Autonomous Provinces, the National Institute of Health, the Italian Medicines Agency, Civil Protection and other public bodies.[26][27][28]Regional authorities adopt strategic-operational pandemic plans and implementation documents, tailored to territorial conditions but aligned with national guidance.[29][27][30]

• Develop regional plans within six months of national-plan approval and implement them within the subsequent 120 days, including governance, service flexibility, workforce training, stockpiles, infection control, communications and resource estimates.[27]
• Coordinate preparedness through an Italian pandemic-preparedness network of regional and autonomous-province focal points and relevant institutions, supported by continuing training and simulation exercises.[31][28]
• Use DISPATCH, the epidemic-intelligence and risk-assessment network, to model possible impacts of emerging influenza viruses and inform contingency-plan updates.[32][33][34]
• Integrate human, animal and wildlife surveillance through a One Health approach, linking InfluNet, the National Influenza Centre, regional laboratories, epidemic-intelligence networks, international alert mechanisms and rapid-alert systems.[7][35][8][36]
• Deliver weekly influenza surveillance bulletins, expand diagnostic, sequencing and laboratory capacity, conduct first-case and outbreak studies, and intensify surveillance and risk assessment during alerts.[37][38][39]
• Plan scalable territorial and hospital delivery through regional service networks, continuity plans, remote triage, home management, alternative facilities, emergency transport and procedures for staff mobilisation.[40][41][42][14]
• Maintain strategic stocks and procurement mechanisms for medicines, vaccines, antivirals, personal protective equipment and medical devices, including stock rotation, national production capacity and extraordinary procurement where necessary.[17][43][18][44]
• Implement annual and cascade-based training, distance learning, periodic simulation exercises, risk communication and community engagement through national, regional and local actors.[45][46][47][48]
• Operate a three-year monitoring, evaluation and updating cycle, including annual regional self-assessment, formal first-year implementation review, a national and regional simulation exercise after two years, and plan revision following exercise findings.[25][49][50]

Regional plans are required to estimate implementation resources and are to be financed through pandemic-specific funds additional to National Health Fund and Regional Health Fund allocations; however, the supplied material does not provide monetary amounts or a consolidated budget.[27]A financed three-year operational plan is required for monitoring, evaluation and updating, but its funding level is not specified.[50]

Monitoring & Evaluation

The plan establishes a three-year monitoring, evaluation and updating cycle for 2021–2023, combining routine surveillance, formal implementation assessment, simulation exercises, regional self-assessment, post-event learning and plan revision.[1][25][50][51]Monitoring is intended to assess regional-plan implementation, territorial effects of national guidance, operational capacity and the effectiveness of preparedness instruments.[25][49]

• Conduct annual self-assessments and formal checks of regional plans, using questionnaires, checklists, documentary evidence, responsible actors and deadlines for inter-pandemic actions.[25][49][50][52][53]
• Report implementation findings to the Italian pandemic preparedness network and use them to develop subsequent roadmaps and update regional and national plans.[25][52][53]
• Run national and regional simulation exercises two years after publication, including table-top exercises, to test operational arrangements, interoperability, resources, roles, technology and sectoral plans.[1][46][54][25][51]
• Review the national plan within one year of simulation exercises and update it by the end of 2023, incorporating new scientific evidence, exercise findings and consultation with regional representatives.[25][51]
• Apply In-Action Reviews and After-Action Reviews following pandemic events and during recovery to identify strengths, weaknesses, unintended effects and recommendations for future plans.[22][23][55]

Surveillance integrates epidemiological, virological, veterinary, event-based, indicator-based and syndromic information. InfluNet combines epidemiological and virological influenza surveillance through a single portal, with data shared with the European Centre for Disease Prevention and Control and the World Health Organization.[28][56]The plan also provides for epidemic intelligence, a national rapid-alert system, International Health Regulations notifications and European Early Warning and Response System exchanges.[7][35][8][57][58]

• Monitor routine influenza-like illness and virological circulation during the inter-pandemic period, intensifying surveillance, laboratory characterisation, early-case studies and risk assessment during an alert.[11][29][7][39]
• Assess epidemic risk weekly at national and regional level, considering hazard, exposure, diffusion, impact on vulnerable groups and health services, and territorial resilience.[59][60][61]
• Track pandemic progression through case trends, incidence, service pressure, hospital and critical-care capacity, admissions, recoveries and deaths.[11][14][62]
• Monitor stocks, consumption and availability of personal protective equipment, medicines, vaccines, medical devices and other essential supplies, and revise projected requirements as epidemiological conditions evolve.[63][44][64]
• Use infection-prevention surveillance to track healthcare-associated infections, assess containment measures and verify readiness in hospitals, residential facilities and outpatient services.[15][65][66][67]

Accountability is principally exercised through Ministry of Health coordination and continuous verification of regional operational capacity, joint Ministry-Region monitoring, designated networks, regional progress reporting, approval acts and transparent public communication.[26][27][31][25]The material does not provide a consolidated national indicator set, uniform reporting templates, performance targets or an independent accountability mechanism.[24][68][7][50]

Costing & Financing

The plan identifies substantial resource requirements for surveillance, laboratories, training, communication, vaccines, antivirals, personal protective equipment, medical devices, hospital and territorial-service capacity, strategic stocks and emergency procurement.[40][41][17][69][18][70]It generally does not provide quantified budgets, cost estimates, funding gaps or economic assumptions.[1][71][50]

• Require regions and autonomous provinces to estimate the resources needed for their pandemic plans and report needs not covered by existing allocations.[27][28]
• Finance regional pandemic-plan resources through pandemic-specific earmarked funds additional to National Health Fund and Regional Health Fund distributions.[27]
• Provide dedicated annual resources for structured inter-pandemic activities for the duration of the plan.[28]
• Develop and approve a financed three-year operational plan for monitoring, evaluation and updating.[50]
• Use advance purchasing, preferential contracts, national and regional stocks, storage facilities and domestic production capacity to secure essential supplies.[72][18][70]
• Support research, laboratory-network upgrading and risk communication through dedicated or adequate funding where available, although no amounts are specified.[73][74][75]

Italy signed the European Community Joint Procurement Agreement in 2014, but the extract reports that insufficient funding prevented participation in a specific European Community procurement arrangement at that time.[72]Recovery planning also calls for quantifying implementation resources, defining additional pandemic-preparedness funding and obtaining Government commitment, without stating an amount.[76]