NATIONAL PREPAREDNESS

PLAN FOR INFLUENZA PANDEMIC

FINAL DRAFT

LEBANON

2007

Executive summary

Introduction

1-Seasonal Influenza:

3- The Avian Influenza H5N1:

4- A severe pandemic scenario:

I- Strategic axis of the plan:

II- Rapid Response Team (RRT)

II.1 Objective

II.2 Team composition

II.3 Meetings

II.4 Roles of the Core team members:

II-5.Roles of the support team members

II.6 Reporting

III- Pandemic phases

III.1 WHO classification of pandemic phases

III.2 Guidelines for actions at different scenarios:

Pandemic phases are declared by the WHO.

III.2.1 Avian inflenza H5N1 presence in birds but no human cases

III.2.2 Isolated human cases: Pandemic alert Phase 3b

III.2.3 Early signals of improved human to human transmission: Pandemic alert Phase 4b

III.2.4 More efficient human to human transmission: Pandemic alert Phase 5b

III.2.5 Pandemic

IV- Surveillance

IV.1 WHO Case Definition for avian influenza A (H5N1)

IV.1.1 Person under investigation

IV.1.2 Suspected H5N1 case

IV.1.3 Probable H5N1 case (notify WHO)

IV.1.4 Confirmed H5N1 case (notify WHO)

IV.2 Case detection:

IV.2.1 Hierarchy of notification

IV.2.2 Epidemiological investigation (Refer to annex 1-4)

IV.2.3 Laboratory tests

IV.2.4 Investigate the source or reservoir

IV.3-Confirmation

IV.4 Surveillance for influenza at ministry of public health

V-Containment response

V.1 Standard measures

V.1.1 Case management

V.1.2 Infection control in health care settings

V.1.3 Antiviral treatment and targeted prophylaxis

V.1.4 Intensified surveillance

V.1.5 Contact tracing

V.1.6 Monitoring contacts for signs of illness

V.2 Exceptional measures

V.2.1 Voluntary quarantine

V.2.2 Social distancing

V.2.3 Mass antiviral prophylaxis

V.2.4 Reporting of adverse events of antivirals.

VI-Antiviral

VI.1 Antiviral treatment for HAI

VI.1.1 Antiviral drugs

VI.2 Antiviral stockpile

VI.3 Requesting and distributing the WHO global stockpile of antivirals

VII-Laboratory

VII.1 Laboratory methods for the diagnosis of AI

VII.2 Specimen collection

VII.3 Specimen collection kit

VII.4 Specimen transport

VII.5 Storing of kit and specimen

VII.6 PCR diagnosis of H5N1:

VII.7 Confirmation at NAMRU-3

VII.8 Disposal of laboratory waste

VII.9 Stockpile and location of specimen collection kit

VII.10 National laboratory capacity building:

VIII- Infection control

VIII.1 Mode of transmission

VII.1.1Seasonal Influenza

VIII.1.2 Pandemic Influenza

VIII.2 Cough etiquette

VIII.3 Personal protective equipments (PPE):

VIII.4 Negative pressure room

VIII.5 Other measures

IX-Vaccine

IX.1 Vaccine for seasonal influenza

IX.2 Vaccine for prepandemic influenza

IX.3 Vaccine for pandemic influenza

X- Communication plan

XI_ Cost

References and supporting documents

Annex 1: Case reporting form

Annex 2: Contact Tracing/Follow-Up Form

Annex 3Daily Situation Report

Annex 4:Case Linelist

Annex 5: Field Data Collection Form

Annex 6: Triple packaging system

Annex 7: Suitability of various storage/shipment conditions for different specimen types

Annex 8: WHO Global Stockpile Antiviral Request Form

Annex: List of district physicians and contact details

Annex: Designated hopitals

Annex: Contact details

Executive summary

-Over the last century there were three pandemics of influenza. The most severe was in 1918 with around 40 millions deaths; the remaining pandemics in 1957 and 1968 were moderate. We are currently in the WHO pandemic alert 3: we have a new subtype of influenza virus,H5N1 that has become well established in birds, can occasionally jump species to cause disease in humans but with very limited clusters of human to human transmission. H5N1 influenza virus, which remains essentially a disease of birds, should be monitored for the fear that it will acquire, or a subtype of it, the genes that allow easy transmission among humans and therefore causing a pandemic.

-A pandemic of influenza A can have disastrous consequences. A virulent virus similar to the one that appeared in 1918 can overwhelm the public health infrastructure with one third of the population becoming infected over the eight weeks average of the pandemic period, and a significant portion requiring hospitalization and many requiring ICU stay and mechanical ventialtion. They will not be enough hospitals beds, ICU beds, and ventilators for everybody. They will be also shortage of medicine and other patient care related items. The best hope is to maximize the preparedness for pandemics, and to identify the early signs of a pandemic to contain it, in the hope of aborting or delaying it until the production of effective vaccine.

-Our plan starts with the formation of a rapid response team (RRT) at the national level. The role of this team is to coordinate preparedness for pandemics and investigates suspected cases of human avian influenza.

-We are adopting the WHO case definition for avian influenza A (H5N1). It has four categories: person under investigation, suspected case, probable case and confirmed case. Cases that fall under this category should trigger an intensive epidemiological investigation. Three or more persons, with suspected or probable human avian influenza constitute an early signal of improved human to human transmission if they are geographically linked and within 10 days of each other. Case suspicion starts usually at the level of the treating physician who will alert the district physician, and the district physician will alert the RRT, which will initiate the investigation.

-Cases should be hospitalized in airborne isolated rooms at Rafic Hariri University Hospital (RHUH). Contact tracing for the last two weeks before onset of symptoms should be initiated, and contact should be monitored for 7 days for fever and cough. Active case searching should be initiated at this point. Patients and their close contact should receive oseltamivir. RT-PCR from pharyngeal swab on patients should be done at RHUH laboratory within 48 hrs of identification of the case. Confirmation samples as well as blood sample for serology will be sent to NAMRU-3 labs in Cairo,Egypt.

-A trigger point for exceptional measures should be established, like two generation nosocomial transmission of avian influenza or a cluster of 5 to 10 suspected cases with at least two confirmed. Those measures include voluntary quarantine, social distancing, and mass prophylaxis of the population at risk. A successful containment strategy is time dependent. Ring prophylaxis has a chance of success if initiated within 21 days following the detection of the first case with improved human to human transmission.

-Containment is heavily relying on antivirals. The government has a stockpile of 3000 treatment course of oseltamivir. This stockpile is going to improve with the addition of 70 kg of oseltamivir powder in the first trimester of 2007 that can be locally processed to provide 70,000 treatment courses. Very close relation with the manufacturer of the drug should be established. Other antiviral drugs like zanamivir should be licensed to be used in Lebanon. For containment efforts the local government can request antivirals from the WHO global stockpile.

-Laboratory diagnosis is performed locally and confirmed abroad. Pharyngeal swab are put on a Viral Transport Media (VTM), with three packaging layers for transport. VTM without the specimen should be stored at -20°C, and can be stored for short period at 4-6°C. VTM with the specimen are stored at 4°C for 48 hrs then at -70°C. There should be a stockpile of 50 specimen collection kit at RHUH laboratory.

-Health care workers and laboratory personel in contact with suspected cases should have full protection with personal protective equipment (PPE). This includesprincipally N95 face mask, long sleeved gown, ambidextrous gloves and eye goggles. Hospitals should have a stockpile of PPE kits.

-Pandemic preparedness involves capacity building. Several areas listed below need further development:

1- More accurate assessment of the burden of pandemic influenza taking into accounts the healthcare resources and availability of those resources.

2- Establishment of a seasonal influenza vaccination program, with the objectives of increasing usage of the vaccine and assuring availability.

3- Enhanced surveillance for seasonal influenza.

4- Assurance of an adequate stockpile of oseltamivir that will be ready to be mobilized in containment efforts.

5- Rapid approval of other antivirals not licensed in Lebanon like zanamivir.

6- Assurance of the presence of adequate stockpile and availability of specimen collection kits.

7- Laboratory diagnosis capabilities:the reference laboratory for the diagnosis of H5N1, should be adequately staffed and provided the capabilites of doing routine PCR diagnosis of viral respiratory infection for the purpose of surveillance. A long term plan for the establishment of a biosafety level 3 laboratory for viral culture of dangerous organisms should be part of the strategic planning. The relation with a WHO reference laboratory outside Lebanon should be enhanced and streamlined.

8- Commercial Diagnostic laboratories should be encouraged to use the available tests (e.g, rapid antigen testing, PCR) for the diagnosis of seasonal influenza and other respiratory viruses.

9- Negative pressure rooms for airborne isolation should be established at RaficHaririUniversityHospital with a governement grant. Other hospitals should be encouraged or required to have at least one negative pressure room in their establishment.

10- Adequate infection control principles should be promoted at the national level. This includes among other the availability in hospitals of an adequate supply of Personal Protective Equipments and the policy and procedure for usage.

11- Training seminars organised by the ministy of public health for the district physicians, aswell as seminars for health care professionals, representatives of the health care institutions of Lebanon (training of the trainers).

12- Hospitals should be required to develop local pandemic preparedness plan and scenarios for surge activities. They should have adequate support and subsequently audited by the ministry.

13- Ongoing studies for the prepandemic vaccine should be monitored, and the plan should be adjusted based on new developments. The government should explore the agreements that can be done to assure the availability of a pandemic vaccine to the Lebanese population in case of a pandemic.

-A communication plan to the general public should be released in collaboration with the concerned parties. Among the items that should be covered, there should be information on cough etiquette, seasonal influenza vaccine, and avian influenza. A clear transparent and consisted message should be formulated in instance of human cases of avian influenza. A spokeperson should be appointed to speak to the public.

-Preparedness should limit the negative impact of an influenza pandemic. It enhances also the capabilities of the country to deal with other major health threats and other epidemic prone diseases.

Introduction

1-Seasonal Influenza:

-Influenza virus cause respiratory infection characterized by fever, coughs, sore throat, and is associated with malaise, and myalgias. It is a self limited disease that lasts 2 to 7 days. Occasionally it is complicated by otitis media, sinusitis and the more serious viral or bacterial pneumonia. The complications are more common in elderly patients, immunocompromised patients, young children, and in patients with chronic respiratory and cardiac disease.

-There are three types of influenza: A, B, and C. Influenza A is the most important because it has the potential to cause pandemics. Influenza is an RNA virus, and this type of viruses are notorious for mutation, that is a change in their genetic composition, that leads to change in their expression which might allow them to escape recognition by the immune system.

-Seasonal influenza occurs each winter, and lasts an average of eight weeks, and cause increased morbidity and mortality due to its complication, mainly in elderly and immunocompromised hosts. The antigenic drift, that is minor changes in the genetic composition of this RNA virus, which leads to minor changes in the surface antigens, is responsible for the seasonal epidemics. For this reason influenza vaccine is adjusted yearly based on the circulating influenza viruses in the preceding season, and is recommended yearly for the population at risk.

-The Influenza vaccine is trivalent, which means it contains three strains of influenza that were circulating in the preceding season. Two strains of influenza A and one strain of influenza B.

-Influenza A is epizootic, it causes disease in birds, in mammals, and in sea mammals. Influenza virus subtype of one species doesn’tusually cause disease in another species. However, animalinfluenza can occasionally jump species to cause disease in humans, similar to what is happening with the avian influenza H5N1. Despite being highly pathogenic, human disease is limited with H5N1, because of the inability of this virus to spread easily among humans.

2- Pandemic Influenza:

-A pandemic is a worldwide epidemic. An epidemic is a significant increase of the incidence of a disease that exceeds its usual rate (the endemic rate). A pandemic occurs when three conditions are fulfilled: a new influenza A virus emerges in the human population with new surface antigens H (Hemaglutinin) and/or N (Neuraminidase) that are not recognised by the human immune system, it should be able to multiply and cause disease in humans, and the third condition it should be able to spread easily from person to person.

-Major genetic changes in influenza A, called antigenic shift, caused by either adaptive mutation of an avian influenza viruses (slow adaptive changes over time) or recombination of a human infuenza with an avian influenza that creates a new strain, can lead to a virus that fulfill the three conditions above and cause a pandemic.

-Over the last century we had three pandemics. In 1918, the Spanish flu due to Influenza A H1N1, caused around 40 Million deaths worldwide, mainly in young population. It is believed, that this virus originally an avian influenza acquired by adaptive mutation the genes necessary to cause disease in humans. Two other moderate pandemics occurred in 1957 (H2N2) and 1968 (H3N1), caused by recombination of human and avian influenza.

3- The Avian Influenza H5N1:

-The Avian influenza H5N1, is a novel influenza subtype for humans and is highly pathogenic. It requires close monitoring to determine if it will obtain the capabilities of pandemic spreadby acquiring the genes that will allow it to spread easily among humans.

--Since its appearance in Hong Kong in 1997, and its reemergence in 2003, it has become widespread in birds. Its presence in birds is confirmed in Asia, Europe and in Africa. It has caused limited human disease in 10 countries, three of them are close to Lebanon namely Egypt, Turkey and Iraq.

-H5N1 remains mainly a disease in birds, it has caused millions of death in birds and just around 200 cases in humans.

-Human acquisition is usually by close contact with infected birds. Incubation period is 2-5 days. It is highly pathogenic for humans with a case-fatality rate of 59%. Very few clusters of human to human transmission have been noted, and it seems it is going to be difficult for this virus to acquire the gene responsible for human to human transmission. But this dreaded possibility can happen, and the virus has evolved since 1997 and has adapted better to humans, and we have currently two clades 1 and 2 with some antigenic differences among them.

- For the risk to domestic birds in Lebanon please refer to the MoAg/FAO document.

4- A severe pandemic scenario:

-In case of a pandemic, with highly pathogenic virus, 1918-like, and for a population of 4.5 Millions like the Lebanese population, around 1.35 Millions person (30%) will catch the illness, half of them will be treated as outpatient, 148,500 patients will require hospitaliation, 22,275 will require ICU beds, 11,200 of them will require mechanical ventilation, with a death toll of 28,350. We’re taking the assumption of a case-fatality rate of 2.1%, much lower than the current case-fatality rate of H5N1 of 59%.

-This mean that there will be an enormous stress on the public health sector, with shortage of hospital beds, ICU beds, mechanical ventilators, medicines, vaccines, personal protective equipments, and health care personnel.

-The country will barely be able to cope with a more moderate scenario. The country has an estimate of 10,000 hospital beds, 900 ICU beds, and we are assuming that it has 400 ventilators. Using the FluSurge program from the CDC for pandemic simulation, a pandemic that lasts eight weeks and has an attack rate of 35% will require at its peaks (4th and 5th week), to use 90 and 100% of the ICUs and ventilators capacity in all the Lebanese territories and around 30% of the hospital beds.

-Efforts to recognize the pandemics at its origin and contain it are important to delay and limit its spread. This national plan outlines the preparedness for such event. It requires the creation of a rapid response team that coordinates efforts and responds to suspected cases, as well as involvement of different sectors in the society, and assisstance of international organisations.

I- Strategic axis of the plan:

-The purpose of this plan is prevention and preparedness. It set out the plan to recognise cases of human avian influenza with potential of human spread and contain it at its source. It also delineates recommendation for preparedness at different stages of the interpandemic.

-This plan resides on six strategic axes:

1-Development of a national Rapid Response Team: it will lead the efforts for preparedness and initiates investigation of suspected human cases.

2-Develop an early warning system: to detect human cases and recognise the cases with enhanced human to human transmission.

3-Strategy of containment by using antivirals and other nonpharmacologic interventions: treating patients and their close contacts with antivirals and using more massive prophylaxis strategy in special circumstances. The purpose is to abort or delay the spread of the virus.

4-Close collaboration with international organisations, mainly WHO: to assure adequate preparedness, and access to the global antiviral stockpile.

5-Training : training of the health care force on influenza preparedness.

6-Capacity building; Preparedness for pandemic influenza should lead to other benefits:

-Improve management and surveillance of seasonal influenza.

-Improve laboratory capacity

-Improve field epidemiology

-Improve awareness andapplication of infection control

-Improve response to other emerging and epidemic-prone diseases.

7- Communication strategy based on adequate communication with the public for information and prevention

-This plan should be updated and expanded at least on a yearly basis to reflect any changes in the interpandemic situation and in the preparedness activities.

II- Rapid Response Team (RRT)

II.1 Objective

-A team of professionals at the national level involves in pandemic preparedness and that investigates suspected cases of human avian influenza and supports the containment response.