ORDER No. 1094 from October 13, 2005
regarding the National Plan of intervention in a flu pandemic and the National Committee formation and the county committees for flu pandemic case intervention.
ISSUER: MINISTRY OF HEALTH
PUBLISHED WITHIN: OFFICIAL JOURNAL NO. 935 from October 20, 2005
Based on the Law No. 100/1998provisions regarding the public health, with the subsequent amendments and the supplements, and on the Government Decision No. 168/2005 regarding the Health Ministry organisation and functioning, with the subsequent amendments and the supplements,
seeing the approval Report of the Public Health Direction, no. E.N. 2.274 from October 11, 2005,
the Ministry of Health issues the following order.
ARTICLE 1
It is approved the National Plan of flu pandemic intervention, stipulated in annex no. I.
ARTICLE 2
It is approved the National Committee and the county committee components for flu pandemic case intervention, stipulated in annex no. II.
ARTICLE 3
It is abrogated the Health Minister’s Order no. 861/2004stipulations regarding the organisation of the National Committee and the county committees for flu pandemic case intervention, as well as other contrary dispositions.
ARTICLE 4
Annexes no. I and II is part and parcel of the present order.
ARTICLE 5
The present order shall be published within the Official Journal of Romania, Part I.
Minister of Health,
Gheorghe Eugen Nicolăescu
ANNEX 1
The NATIONAL PLAN
Of intervention in a flu pandemic
Abbreviations:
MS - Ministerul Sănătăţii (Ministry of Health)
CNIP - Comitetul Naţional de Intervenţie în caz de Pandemie de Gripă (National Committee for flu pandemic case intervention)
CJIP - Comitetul judeţean de intervenţie în caz de pandemie de gripă (CountyCommittees for flu pandemic case intervention)
CNG - IC - Centrul Naţional de Gripă - Institutul Cantacuzino (National Flu Centre – Cantacuzino Institute)
CNAS - Casa Naţională de Asigurări de Sănătate (The National House of Health Insurances)
OMS - Organizaţia Mondială a Sănătăţii (World Health Organisation)
ANM - Agenţia Naţională a Medicamentului (Medicine National Agency)
DSP - Direcţia de sănătate publică (Public Health Direction)
ISP - Institutul de Sănătate Publică (Public Health Institute)
MAI - Ministerul Administraţiei şi Internelor (Ministry of Administration and Home)
MApN - Ministerul Apărării Naţionale (Ministry of National Defence)
MTCT - Ministerul Transporturilor, Construcţiilor şi Turismului (Ministry of the Transports, Construction and Turism)
MJ - Ministerul Justiţiei (Ministry of Justice)
MEC - Ministerul Educaţiei şi Cercetării (Ministry of Education and Research)
SRI - Serviciul Român de Informaţii (Romanian Information Service)
SIE - Serviciul de Informaţii Externe (External Information Service)
INCDMI - Institutul Naţional de Cercetare-Dezvoltare în
"Cantacuzino" Microbiologie şi Imunologie "Cantacuzino" (The National Institute of Research-Development in “Cantacuzino” Microbiology and Immunology “Cantacuzino” )
Declaration of principles:
- MS agrees and sustains the participation of Romania at the national, regional and international intervention measures in the case of a flu pandemic.
- MS, through the minister of health, shall assure the Government and the local board involvement in taking some political, economical and financial, and social decisions regarding a flu pandemic case emergence.
- Because the flu pandemic is considered a calamity, the Government as well as the MS shall assure the participation of the representatives of all the society activity segments at the intervention measures.
A. Objectives:
- the morbidities, complications and deceases reductions;
- the social disorders and economical losses limitation.
B. Directions (activities/actions)
I. General measures (organisational):
- CNIP and CJIP establishment;
- local (county) plans elaboration regarding the flu pandemic intervention.
II. Specifically measures:
1. surveillance;
2. cases management;
3. chemoprophylaxis and extensive vaccination of the population;
4. the antiviral therapy of the sever and/or complicated flu.
III. The flu pandemic phases and the preparation levels
The inter-pandemic period
Phase 1. No new influenza subtypes have been detected in human population. An influenza virus subtype that has caused human infection may be present in animals. If present in animals the risk *1) of human infection or disease is considered to be low.
Phase 2. No new influenza virus subtypes have been detected in human population. However, a circulating animal influenza virus subtype poses a substantial risk *1) of human disease.
The pandemic alert period
Phase 3. Human(s) infection(s) with a new subtype, but no human-to-human spread, or at most, rare instances of spread to a close contact *2).
Phase 4. Small pest hole(s) with the a new subtype virus, with limited human-to-human transmission but the spread is highly localised, suggesting that the virus is not well adapted to humans *2).
Phase 5. A bigger pest hole (bigger pest holes), but the human-to-human transmission is still limited, suggesting that the virus is becoming increasingly better adapted to humans, but may not yet be fully transmissible (represents a substantial pandemic risk *2).
The pandemic period
Phase 6. Increased and sustained transmission in general population *2).
The post-pandemic period
The re-emergence at the inter-pandemic period.
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*1) The difference between phase 1 and phase 2 is based on the risk of human infection or of the disease caused by the circulating subtypes at animals. The distinction is based on different factors and on their importance in accordance with the scientifically information. The factors may include: the animal and human pathogen level; the occurrence at the domestic animals and at those living in farms or only at the wild animals; if the virus is enzoonetic or epiozoonetic, geographically localized and wide spread; other information regarding the viral genome and/or other scientifically information.
*2) The distinction between phases 3, 4, 5 and 6 is based on the pandemic risk assessment. It must be taken into account different factors as well as their importance in accordance with the scientifically information. The factors may include: the transmission rate; the geographically localisation and the spread; the disease astringency; the genes presence originated in the human subtypes (if the virus derived from an animal subtype); other information regarding the viral genome and/or other scientifically information.
IV. Communications:
- the circuit of the specialized information;
- the circuit of the public interest information;
- warning/notifying the population.
C. Methodology
I. General measures
a. Control/coordination/decision structures
1. at the central level: CNIP (MS, CNG - IC) – component (WHO model)
- enhanced:
a) authority representatives (that ca function in case of necessity):
- MS – Public health direction (director, second-in-command);
- CountyDSP and BucharestMunicipality (general director, second-in-command – preventive medicine);
- ANM (the president or the chief of the biological products compartment);
- MS – The pharmaceutical and medical devices general direction (general director);
- CNG - IC (the central chief and the diagnostic compartment manager);
- the Virology Institute director and/or flu laboratory chief;
- National Committee of Epidemiology co-presidents;
- National Committee of Infectious Diseases co-presidents;
b) The General Physicians National Association (president); the general physicians county association (presidents); the Pneumology National Institute "Marius Nasta" director; the county pneumology sections chiefs or the pneumologists designated by these; the syndicate representative or the National Association of the Medical Assistants representative; one representative of the Physicians’ Collegium of Romania and one representative of the Pharmacists’ Collegium of Romania;
c) the virology and epidemiology departments chiefs from the ISP (Bucharest, Cluj-Napoca, Timişoara, Iaşi); microbiology department chiefs or the virology disciplines chiefs (Bucharest, Arad, Craiova, Cluj-Napoca, Braşov, Iaşi, Constanţa, Sibiu, Oradea, Timişoara); the chiefs of the epidemiology department from the same universities; the clinics and the infectious diseases department chiefs;
d) the Veterinary Diagnostic Centre Laboratory director and/or the virology department chief; the sanitary and veterinary county laboratories chiefs and/or designated virologists; the microbiology departments or the virology disciplines chiefs from the veterinary medicine faculties;
e) the representatives of the flu vaccine national manufacturer (the second in command for production and the coordinator of the production area regarding the flu vaccine from INCDMI "Cantacuzino");
f) the representatives of the Pharmaceutical Products Exporters and Importers Association and those of the distributors;
g) a Ministry of Labour, Social Solidarity and Family representative;
h) representatives of the county directions of assistance and social protection;
i) the chief of the infectious diseases fight and prevention compartment from the health directions of MApN and MAI;
j) a civil protection representative – central organism;
k) a Red Cross representative – central organism and, eventually, a Red Crescent representative;
l) a representative/representatives of the religious cults;
m) mass-media representatives (journals, televisions, press agents, radio);
- the central nucleus (executive) with a permanent activity:
- a public health direction representative (director);
- a MS general direction pharmaceutical and medical devices representative;
- a MS general direction representative of the medical assistance, sanitary and remuneration structures (general director/second-in-command);
- a CNG - IC representative (centre chief);
- the INCDMI "Cantacuzino" second-in-command for health programs;
- a specialist in the flu vaccine production;
- the INCDMI "Cantacuzino” general director;
- a representative of the Pneumology National Institute "Marius Nasta" (director);
- a MApN medical direction representative (second-in-command);
- a MAI medical direction representative (second-in-command);
- a MTCT medical direction representative (chief epidemiologist);
- a MJ medical structure representative;
- a SRI medical structure representative;
- a SIE medical structure representative;
- a MAI representative (non-medical personal, as a representative of the local administration);
- a representative of the General Institute for Emergency Situations (specialized personal, non-medical);
- the MS Epidemiology National Committee co-presidents;
- the MS Infectious Diseases National Committee co-presidents;
- a ANM representative (chief compartment biological products);
- a General Physicians National Association representative;
- a mass-media representative;
2. at local level: recommended component of CJIP (DSP):
- the DSP second-in-command for preventive medicine;
- the DSP epidemiology compartment chief;
- chiefs of academic clinics/sections with infectious diseases, internal medicine, paediatrics, and pneumology profile;
- a representative of the pharmacists county collegium;
- the DSP microbiology county laboratory chief;
- a representative of the health insurances county house;
- a MAI medical representative, within the county medical centres, as well as of the Bucharest municipality, from their own network;
- a MAI medical representative;
- a SRI medical structures representative;
- a SIE medical structures representative;
- a representative of the sanitary and veterinary county authority;
- the president of the general physicians county association;
- the director of the county ambulance station;
- a mass-media representative.
b. Executive units:
- surveillance: countyDSP and those of the Bucharest municipality (general physicians cabinets, county laboratories, epidemiology compartment), medical directions (epidemiology compartment: MApN/MAI/MTCT, CNG - IC, The Diagnostic and Animal Health Institute);
- cases management: countyDSP (general physicians, hospitals, ambulance stations, pharmacies, medicaments magazine);
- chemoprophylaxis an extensive vaccination of the population: countyDSP (general physicians cabinets, vaccination centres);
- vaccine production: INCDMI "Cantacuzino" (depending on the possibilities, doses supplementation through acquisitions/redistributions – WHO); the vaccine and antiviral distribution: national (MS), local (DSP, pharmacies and magazines);
- the antiviral treatment of a sever/complicated flu: general physicians cabinets, hospitals.
II. Specifically measures
1. Surveillance:
a) monitoring the human flu viruses circulation, through the viruses isolation/detection from the pathologically products sampled in every region of the country from pest holes and from persons with affections similar to flu, from ambulatory, interned or who came from/have made visits from/in the affected areas during the current season or out of season in case of a flu pandemic outbreak;
b) monitoring the animal flu viruses circulation by the sanitary and veterinary authorities with the assistance of the CNG - IC;
c) the serologic diagnostic usage enhancement with the assistance of the CNG - IC in all the county laboratories (DSP) and/or in the laboratories from the infectious diseases clinics (hospitals) (if case, rigging and personal training);
d) the preparation and supplying with reagents for serologic diagnostic (HI) of the county laboratories by the CNG - IC;
e) the surveillance of the unspecific indicators evolution of the flu activity (morbidity, mortality, absenteeism, medicine consumption etc.);
f) the preparation of reagents for the virology diagnostic (the antigenic characterisation of the isolated) from the reference viruses for the current season and from the pandemic virus (source WHO) by the CNG - IC.
2. Cases management:
a) the general assistance insurance (consultants, home visits);
b) the emergency assistance insurance (ambulance, watch houses, intensive therapy);
c) the insurance of the hospitalisation spaces;
d) the insurance of the medicaments and sanitary materials stockpiles (syringes, needles, masks etc.).
3. Chemoprophylaxis and the extensive vaccination of the population:
- choosing the vaccination strategy and establishing the optimum necessary of vaccine doses;
- establishing the antiviral necessary for prevention and severe cases treatment.
III. Phases description and preparation levels:
The inter-pandemic period
Phase 1. No new influenza subtypes have been detected in human population. An influenza virus subtype that has caused human infection may be present in animals. If present in animals, the riskof human infection or disease is considered to be low.
Phase 2. No new influenza virus subtypes have been detected in human population. However a circulating animal influenza virus subtype poses a substantial risk of human disease.
Actions that must be taken: flu surveillance and control in accordance with the annual action plan.
The pandemic alert period
Phase 3. Human(s) infection(s) with a new subtype, but no human-to-human spread, or at most, rare instances of spread to a close contact.
This level of preparation is instituted after the first reports regarding the new viral subtype isolation, without existing clear proofs of such a virus spreading or of an activity in the pest hole associated with the new virus.
Actions that must be taken:
- surveillance intensification through increasing the flu virus isolators and serologic diagnostic;
- reagents request – from WHO – for the new flu virus subtype;
- antigenic characterisation, isolators that differ significantly from the circulating subtypes are send to the reference regional centres;
- monitoring the persons that travel to or from the areas where the new flu virus subtype has been isolated.
Phase 4. Small pest hole(s) with the a new subtype virus, with limited human-to-human transmission but the spread is highly geographic localised, suggesting that the virus is not well adapted to humans.
This level of preparation is instituted in the moment when there have been confirmed two or more cases of infection with the new viral subtype in humans, but when the virus’s capacity of spreading immediately from human to human and its capacity of causing multiple pest holes that can result in the epidemic occurrence, remains scant (low).
Actions that must be taken:
- the case definition communication regarding the new viral subtype to all the partners from the surveillance system;
- the national surveillance intensification through increasing the number of isolators and their characterisation, using reagents prepared for the new viral subtype – the emergency delivery of the isolators similar to the new viral subtype at the reference regional centres;
- persons surveillance;
- the intense participation at the regional and international surveillance;
- the national manufacturer training regarding the preparation of the new viral subtype vaccine;
- the production capacity increase, fast authorisation and distribution of the vaccine;
- the activation of the pandemic preparation plan.
Phase 5. A bigger pest hole (bigger pest holes), but the human-to-human transmission is still limited, suggesting that the virus is becoming increasingly better adapted to humans, but may not yet be fully transmissible (represents a substantial pandemic risk.
This level of preparedness regards the situation in which the new viral subtype transmission to human has been confirmed by the existence of some clear proof regarding the human-to-human spread, within the general population, as in the secondary cases that result after the contact with a index case, with at least one pest hole having a minimum period of two weeks in a country.
Actions that must be taken:
- the transmission of the case definition regarding the new viral subtype to all partners from the surveillance system;
- the increase of the isolation number and their characterisation, using reagents prepared for the viral subtype and those that are different from the reference subtypes are transmitted to the reference regional centre for flu;
- the vaccine preparation, using the new subtype, simultaneous with the vaccine preparation for the current season;
- the production capacity assessment, the government funds allocation for the production, the vaccine distribution optimisation and the possibilities studying (through international consulting - via WHO) in order to purchase from other producers a number of doses for increasing the vaccination cover of the population;
- the intensification of the information dissemination received from WHO regarding the particular characteristics of the new virus, its spreading and control;
- the usage of information regarding the new subtype for the activation and re-updating of the national plan of preparation;
Pandemic period
Phase 6. Increase and sustained transmission within the general population *2).
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*2) See note 2) from page 7.
The start of a pandemic is declared when the WHO confirms that the a virus with a new haemaglutinic subtype, in comparison with the recent epidemic subtypes, begins to determine the occurrence of several pest holes in at least one country and spreads in other countries, having an epidemiologic model of the disease that indicates the existence, with a large probability, of a severe morbidity and mortality occurrence within at least one segment of the population.
This level of preparation is necessary when the pest holes ad epidemics appear in more countries and is observed the spread of the virus from one region to another.
The activity increase in the states or regions initially affected has stoped or has changed, but in other regions continues to appear pest holes and epidemics.
Based on the accumulated experience, it is expected that within 3- 9 moths from the first epidemic date to appear at least the second wave of epidemic in some states.