July 11, 2014
ADMINISTRATIVE ORDER
No. 2014 – 0023
DESIGNATION OF THE RESEARCH INSTITUTE FOR TROPICAL MEDICINE
(RITM) AS THE PHILIPPINE NATIONAL INFLUENZA CENTER (PNIC)
I. RATIONALE/BACKGROUND
Influenza
is a recurring respiratory condition recognized as occurring particularly
during the winter months in temperate countries where influenza was first
observed. Influenza has high morbidity rates for children and for adults about
60 years old, patients with chronic illness and pregnant women. The influenza
virus A that affects human mutates easily, often causing new antigenic
variants, and the occurrence of influenza pandemic. The 1957 – 1958 Asian
influenza was caused by Influenza A/H2N2, while the HongKong flue which took
place in 1968 – 1969, resulting in nearly one million deaths, and was caused by
Influenza A/H3N2. The SARS outbreak in 2004 also demonstrated the speed by
which new and emerging infections may be transmitted. The occurrence of a potential
influenza pandemic is unpredictable, imminent and possibly inevitable. In 2009,
the world experience the 2009 Influenza A/H1N1 pandemic resulting in 18,000
deaths according to the World Health Organization.
The
Philippine Disease Integrated Surveillance and Response (PIDSR) is a
multifaceted public health disease surveillance system that provides public
health officials the capabilities to monitor the occurrence and spread of
disease. The goal of the PIDSR is to strengthen surveillance and response
capabilities at each level of the health system by building local capacities
and leveraging strengths and areas of expertise through partnership and
coordination. The vision of PIDSR is to improve the availability and use of
surveillance and laboratory data so that public health managers and decision
makers can plan for and carry out more timely detection and response to the
leading causes of illness, death and disability. Information from the PIDSR is
expected to be used for the following purposes:
· Facilitate
collection, managing, analyzing, interpreting and disseminating health related
data for diseases designated as nationally notifiable,
· Develop and
maintain national standards, such as consistent case definitions for nationally
notifiable diseases) applicable across all the provinces and cities,
· Maintain the
official national notifiable diseases statistics,
· Provide detailed
data to control programs to facilitate the identification of specific disease
trends; and
· Work with cities
and provinces and partners to implement and assess prevention and control
programs.
Influenza–like–illness
(ILI) is among the notifiable diseases under the PIDSR. In addition to
obtaining epidemiologic information, it also collects data on whether
laboratory confirmation was done as the ILI case either through virus isolation
or polymerase chain reaction (PCR). It also classified ILI cases as either
suspect or laboratory confirmed, thereby highlighting the role of laboratory
procedures as necessary in the classification of ILI cases.
The
Global Influenza Surveillance and Response System (GISRS), previously known as
the Global Influenza Surveillance Network (GISN), have set up a network for the
conduct of influenza virological surveillance since 1948. An integral part of
GISRS activities is the laboratory diagnosis and virological surveillance of
circulating influenza viruses – key elements in both influenza vaccine virus
selection and the early detection of emerging viruses with pandemic potential.
The primary aims of the system have been threefold: to monitor changes in
antigenicity of influenza viruses; to guide the selection of strains for the
annual influenza vaccine; and to provide virus samples for use in vaccine
production. The GISRS consist of over 130 National Influenza Centres (NICs)
around the world that collects and test clinical specimens, submitting a sample
of these to WHO Collaborating Centers and Essential Regulatory Laboratories for
further characterization. In effect that GISRS has contributed significantly to
the protection of global public health by updating seasonal influenza vaccine
compositions and by functioning as a global alert mechanism for the emergence
of influenza viruses with pandemic potential.
The
Research Institute for Tropical Medicine participated in the GISN as the
country’s sole National Influenza Center in 2005. The WHO recognized the RITM
insofar as influenza surveillance information is concerned and has participated
in all the NIC related activities as called for by both the WHO and US – CDC.
This was further facilitated by a grant provided by the US – Center for Disease
Prevention and Control (CDC) that RITM and the Department of Health’s National
Epidemiology Center (NEC) to develop a national influenza surveillance for the
country from 2005 to 2010. Because of an oversight, the RITM was not designated
the country’s NIC by its national authorities, in this case, the Department of
Health, although it has functioned as such for nearly a decade now. It is about
time for the RITM to be officially designated as the Philippines’ National
Influenza Center.
II. DECLARATION
OF POLICIES
The
creation and organization of the PNIC shall be guided by the following legal
mandates and policies:
A. Republic Act 3573 (Law of Reporting of Communicable
Disease) requires all individuals and health facilities to report notifiable
disease to local and national health authorities. Influenza is among the
notifiable disease of the DOH through the NEC.
B. Resolution WHA 48.13 (1995) urges all Member States to
strengthen national and local programs of active surveillance for infectious
disease, ensuring that efforts are directed towards the early detection of
epidemics and prompt identification of new emerging and re–emerging infectious
diseases.
C. Resolution WHA 58.3 (2005) urges all Member States to
develop, strengthen and maintain, as soon as possible, but not later than five
years from the entry into force of the revised International Health Regulations
(IHR), the capacity to detect, assess, notify and report events in accordance
with these regulations.
D. Resolution WHA 58.5 (2005) urges all Member States to
develop and strengthen national surveillance and laboratory capacity for human
influenzas.
E. Resolution WHA 59.2 (2006) urges all Member States the
mobilization of financial support, in building, strengthening and maintaining
the capacity for influenza surveillance and response in countries affected by
avian influenza or pandemic influenza;
F. Resolution WHA 64.5 (2011) urges all member states
particularly developing countries to develop national laboratory and influenza
surveillance capacity including: the early detection, isolation and
characterization of viruses, participate in pandemic risk assessment and
response, develop research capacity related to influenza and achieve technical
qualifications for consideration of laboratories as National Influenza Centers.
G. Administrative Order 2005 – 0023 (Implementing
Guidelines for Formula One for Health as Framework for Health Reforms) Section
C2 states that “Disease surveillance shall be intensified to ensure that the
targets for disease elimination prevention and control are attained.”
H. Department Personnel Order No. 2005 – 1585 (Creation
of Management Committee on Prevention and Control of Emerging and Re–emerging
Infectious Diseases (DOHMC – PCREID) creates the Epidemiology and Surveillance
Sub-committee (ESSC) in which one of its major functions is to “…formulate and
recommend policies, standards, procedures guidelines and systems on the early
detection, contract tracing, surveillance, investigation and follow–up of
emerging and re–emerging (EREID) suspects and the timely and accurate
recording, reporting and collation of epidemiological data on EREID.”
I. Administrative Order No. 2007 – 0036 (Guidelines on
the Philippine Integrated Disease Surveillance and Response (PIDSR) Framework.
This administrative order provides the framework for the PIDSR to guide its
implementation at all levels of the health care delivery system as well as both
the public and private sectors.
III. GOALS AND
OBJECTIVES
A. The designation of a functional, integrated and
sustained National Influenza Center resulting in the appropriate response
during influenza pandemics and policy recommendations for influenza prevention
and control.
B. General Objective
1. To develop, improve/strengthen and sustain influenza
laboratory surveillance in the country.
2. To provide continuous, timely and accurate influenza
laboratory surveillance information to guide influenza pandemic response or
interventions for all stakeholders from the national to the local levels.
C. Specific Objectives
1. To designate the Research Institute for Tropical
Medicine as the Philippine National Influenza Center.
2. To define the terms of reference, duties and
responsibilities of the PNIC.
3. To provide guidelines for the establishment,
organization, operationalization and sustainability of the PNIC.
4. To provide the mechanism by which the PNIC support
influenza disease surveillance by the NEC and response by the National Center
for Disease Prevention and Control – Infectious Disease Office (NCDPC – IDO),
during the inter–pandemic period and during pandemic periods.
5. To define the terms of reference, duties,
responsibilities and operations of the influenza sub–national laboratories.
IV. SCOPE AND
COVERAGE
This
Administrative Order covers the designation of the RITM as the Philippine
National Influenza Center (PNIC) its terms of reference, tasks and
responsibilities and the provisions required for its continued operations and
sustainability. It also covers the creation and terms of reference of the
influenza sub–national laboratories.
The
guidelines and standards prescribed thereto shall be applied to, and benefit,
the entire health sector, with the Department of Health as the lead agency.
V. DEFINITION
OF TERMS
Disease
surveillance – the systematic
continuing assessment of the health of a community, based on the collection,
interpretation and use of health data. Surveillance provides information
necessary for public health decision – making.
Influenza
epidemic – an outbreak of influenza
caused by influenza A or B viruses that have undergone antigenic drift. The
terms “influenza epidemic” and “influenza outbreak” have the same meaning, and
may occur locally or in many parts of the world during the same season.
Influenza
pandemic – by conversion, worldwide
outbreaks of influenza caused by influenza A viruses that have undergone
antigenic shift. A pandemic is a global disease outbreak. A flue pandemic
occurs when a new influenza virus emerges for which people have little or no
immunity and for which there in no vaccine. The disease spreads easily person–to–person,
causes serious illness, and can sweep across the country and around the world
in very short time.
Influenza
inter–pandemic period – the influenza
inter–pandemic period has two phases. In phase 1, no new influenza virus
subtypes have been detected in humans; the influenza virus subtype that has
caused human infection may be present in animals, but the risk of human
infection or disease is considered to be low. In Phase 2, although no new
influenza virus subtypes have been detected in humans, there is a circulating
animal influenza virus subtype posing a substantial risk or human disease.
National
Influenza Centers – are institutions
recognized by the World Health Organization to perform influenza virological
surveillance. These NICs collect specimens in their country; perform primary
virus isolation and preliminary antigenic characterization. The also ship newly
isolated strains to WHO Collaborating Center for high level antigenic and
generic analysis, the result of which forms the basis for WHO recommendations
on the composition of influenza vaccine for the Northern and Southern
Hemisphere each year.
Influenza
Virological Surveillance – the
ongoing and systematic collection and analysis of influenza viruses in order to
monitor their characteristics.
Polymerase
Chain Reaction – a powerful,
molecular technique for the identification of influenza virus genomes even when
they are present at very low levels.
VI. GENERAL
PROVISIONS
The
International Health Regulations of 2005 aims to protect countries against
international disease spread while avoiding unnecessary interference with
global travel and trade. Succeeding resolutions of the World Health Assembly
from 2005 to 2011, highlighted the urgency and the significance of developing
national laboratory and influenza surveillance capacity including the
mobilization of financial support for strengthening and sustaining this
laboratory capacity. As a member state of the World Health Assembly, the
Philippines has the obligation to prevent and control the spread of disease
inside and outside its borders, especially for diseases like influenza which is
both emerging and re–emerging disease.
In
recognition of this, the Department of Health hereby orders that the Research
Institute for Tropical Medicine is the country’s National Influenza Center and
shall receive the technical, logistic and financial support to perform its functions.
VII. GUIDELINES
FOR THE OPERATIONS OF THE PNIC
1. Organizational
Structure of the NIC
Disease
Prevention and Control Bureau – Infectious Diseases for Prevention and Control
Division (DPCB – IDPCD)
This
office is primarily responsible for the development and implementation of the
integrated national preparedness and response plan, to provide updates,
technical advice and recommendations on the recognition, prevention and control
of diseases and the organization of the DOH Management Committee for the
Prevention and Control of Emerging and re – emerging Infectious Diseases, to
provide logistical support for surveillance and laboratory activities. EB shall
share with the DPCB the report on influenza laboratory confirmed cases.
Epidemiology
Bureau (EB)
This
office is primarily responsible for collection of information on notifiable
diseases through the PIDSR and detecting or confirming disease outbreaks.
Through its sentinel sites, it will refer ILI from its sentinel sites to the
PNIC for influenza laboratory testing. Since ILI is among the notifiable
diseases for which information is required to classify an ILI case as suspected
or laboratory confirmed, the PNIC will report to the EB all the laboratory
results of ILI cases from whom nasal swabs are obtained. It is also responsible
for providing logistical support surveillance activities which includes
laboratory confirmation.
Philippine
National Influenza Center (PNIC)
Within
the RITM, the PNIC is composed of three departments: Virology, Molecular Biology
and Epidemiology and Biostatistics. The functions of these departments are as
follows
a. Department
of Virology (DV)
This
department is responsible for the detection of influenza and other viruses
using Polymerase Chain Reaction (PCR) and viral isolation techniques. This will
require the laboratory to maintain several cell lines to allow for the
detection of a variety of respiratory pathogens, in addition to influenza. The
DV is also responsible for the typing subtyping and further determining the
antigenic characteristics of influenza viral isolates using haemagglutination
inhibition (HAI) test. In instances when isolates need confirmation or are
unsubtypable, the department will send these isolates to a WHO Collaborating
Center. The department is also responsible for the training of health workers
in the collection, storage and transport of specimen in different sentinel
sites.
b. Molecular
Biology Department
This
department is responsible for the application of molecular techniques to
directly detect influenza A or B genetic material in respiratory samples or
viral cultures. The employment of these techniques can greatly facilitate the
identification of human influenza A subtypes including those with potential to
cause a pandemic and thus expedite the investigation of outbreaks or
respiratory illness. It is the primary department responsible for processing of
specimen during influenza pandemic and the training of sub – national
laboratories staff in the use of conventional and real – time PCR for influenza
detection.
c. Department
of Epidemiology and Biostatistics (DEBS)
This
department is responsible for the date management of the data collected and
generated by the PNIC. It is also responsible for the provision of information
on influenza activity in the country to the Epidemiology Bureau (EB) of the
Department of Health and the World Health Organization through the FLUNET.
Office
of the director of RITM
The
Office of the director of RITM is at the same time Director of the PNIC, who
has administrative responsibilities over the departments under the NIC. Its
operations are overseen by the Center Management Team (CMT) which is composed
of the departments under the PNIC, including the Institute’s Chief
Administrative Officer and Head of the Accounting Departments.
Sub–national
Laboratories
These
are laboratories housed in regional hospitals and equipped with the facility
required to perform real time PCR procedures on influenza samples collected.
2. Functions
of the PNIC
a. General
Functions of the PNIC
(1)
Provides
laboratory support for the ILI and SARI surveillance of the EB, as part of its
Philippine Integrated Disease Surveillance and Response (PIDSR), through the
laboratory diagnosis of influenza using viral isolation and/or molecular
techniques.
(2)
Continuously
strengthen the PNIC capacity to support ILI and SARI surveillance, influenza
outbreaks and pandemic through (1) the recruitment, hiring and training of
adequate personnel, (2) acquisition of appropriate equipment, (3) participation
in regular influenza conferences, meetings and training activities conducted by
WHO, CDC and other relevant authorities and (4) participation in the WHO
influenza quality assurance activities.
(3)
Makes
recommendations for the setting up of additional sub–national laboratories or
in the upgrade of laboratory equipment in these laboratories, if necessary.
(4)
Trains staff of
the sub–national laboratories in the timely and accurate detection of pandemic
influenza viruses using appropriate molecular techniques, i.e., Real Time PCR.
(5)
Provides
proficiency and external quality assessment for the sub– national laboratories
in the detection of influenza virus types by PCR to monitor the quality of its
diagnoses and identify gaps of PCR testing in these laboratories.
(6)
Provides
technical assistance in the conduct of SARI surveillance in the hospitals
housing sub–national laboratories.
(7)
Acts as the
national reference laboratory for influenza.
(8)
Serves as the
resources for training on influenza surveillance of the Department of Health.
(9)
Serves as the key
point of contact with the DOH Epidemiology Bureau and the World Health
Organization in all concerns and questions relating to influenza virological
surveillance.
(10)
Maintains active
communication with the EB and the members of the WHO – GISN through (1) the
timely submission of virus isolates to the WHO Collaborating Centers, (2)
prompt information on isolation of unusual viruses or disease outbreaks, (3)
weekly reports on influenza activity during the influenza season and the
provision of any other relevant information on influenza surveillance and
control of FLUNET and other health authorities.
b. Specific
Functions of the PNIC
During
the Intrapandemic Period
(1) Provides laboratory support for the routine ILI and
SARI epidemiologic surveillance conducted by the EB as part of its Philippine
Integrated Disease Surveillance and Response (PIDSR).
(2) Process collected clinical specimen from (1) routine
ILI and SARI surveillance and (2) during influenza outbreaks for the detection
and/or isolation of influenza virus.
(3) Provides guidance and training in the biosafety
requirements for influenza diagnosis – including the safe handling, storage and
transport of specimen.
(4) Conducts seasonal influenza virus isolation and
preliminary analyses of the virus isolates and send representative isolates to
the WHO – Collaborating Center.
(5) Monitor continuously the influenza circulating strains
in the country and remains alert to non–subtypeable or low–reacting virus
isolates.
(6) Acts as collection point for virus isolates from sub –
national laboratories, where available.
(7) Participates in the pandemic planning of the
Department of Health.
(8) Provides regular guidance and training to the sub–national
laboratories involved in the influenza surveillance and diagnosis to ensure
that basic PCR skills are maintained.
(9) Provides regular quality assurance process on the sub–national
laboratories in the detection of influenza virus types by PCR.
(10) Develops surge
capacity plans in response to possible needs during the pandemic.
(11) Transport
representative seasonal influenza virus isolate to WHO Collaborating Centers to
contribute to the annual WHO annual recommendations on seasonal influenza
vaccine composition.
(12) Provides weekly
report on circulating virus strains in the country to the EB and the WHO
FLUNET.
(13) Alerts the EB and
the WHO – GISN of the:
(a) Emergence of unusual outbreaks of influenza–like–illness
(ILI) or severe acute respiratory illness (SARI);
(b) Indications of the emergence of influenza viruses with
pandemic potential.
(14)
Forward
representative virus isolate and any low reacting viruses to a WHO
Collaborating Center for confirmation and further characterization.
During
the Pandemic Period
(15) Ensures that it
is fully equipped with the necessary materials and reagents to detect new
subtypes of influenza infection in humans as early as possible.
(16) Provides the
national authorities with the necessary virological information for the
necessary development, amendment and implementation of the national
preparedness plan.
(17) Provides sub–national
laboratories with the necessary reagents and training required to detect the
new subtypes of influenza infection.
(18) Ensure the prompt
and timely reporting of laboratory results of cases to the referring
facilities, EB and the WHO – GISN.
(19) Provide laboratory
diagnosis for monitoring the geographical spread of the pandemic in the country
to the EB.
(20) Performs viral
susceptibility testing on the pandemic virus.
(21) Confirms
detection of new virus for those which may not be detected by the sub–national
laboratories.
(22) Maintains
enhanced virological surveillance for the early detection of a possible
subsequent rise in pandemic influenza activity.
(23) Where possible
conduct serological studies to understand the spread and other features of the
pandemic.
(24) Coordinates
closely with the Department of Health Central Office for the planning,
response, and reporting requirements of a pandemic.
c. Functions of
the Sub–national Laboratories
During
the Intrapandemic Period
(1)
Provide
laboratory support for the routine ILI and SARI epidemiologic surveillance
conducted by the EB as part its Philippine Integrated Disease Surveillance and
Response (PIDSR) System.
(2)
Process collected
clinical specimen from routine SARI surveillance conducted in its hospitals and
other hospitals in its catchment area.
(3)
Participate in the
quality assessment procedures of the PNIC by sending representative isolates
for confirmation or further characterization.
(4)
Monitor
continuously the influenza circulating strains in the hospitals or regions and
remain alert to non–subtypeable or low–reacting virus isolates.
(5)
Participate in
the pandemic planning of the provincial and regional health offices and local
government units.
(6)
Develop surge
capacity plans in response to possible needs during the pandemic.
(7)
Provide weekly
report on influenza virus strains in the hospital or the region to the Regional
Epidemiological Surveillance Unit (RESU), PNIC and EB.
During
the Pandemic Period
(1)
Process collected
clinical specimen from suspected pandemic cases from the sub–national
laboratory’s catchment area.
(2)
Ensure that it is
fully equipped with the necessary materials and reagents to detect new subtypes
of influenza infection in humans as early as possible.
(3)
Provide the PNIC
with the necessary virological information for the necessary development,
amendment and implementation of the national preparedness plan.
(4)
Ensure the prompt
and timely reporting of laboratory results of cases to the referring
facilities, local government units, RESU, PNIC and EB.
(5)
Provide laboratory
diagnosis for monitoring the geographical spread of the pandemic in its
catchment area, province or region.
(6)
Maintain enhanced
virological surveillance for the early detection of a possible subsequent rise
in pandemic influenza activity.
(7)
When possible
conduct serological studies to understand the spread and other feature of the
pandemic.
Sentinel–site
Hospitals (where Sub–national Laboratories are Located)
(1) Appoint or designate disease surveillance coordinator,
preferably the Infectious Disease Physician in the hospital to be responsible
for the conduct of Severe Acute Respiratory Infections (SARI) surveillance in
the hospital.
(2) Train physicians and nurses at the Emergency Room and
in the wards in the conduct of Severe Acute Respiratory Infection (SARI).
(3) Request technical assistance from the Epidemiology
Bureau or from the RITM in the training of hospital staff for SARI
surveillance.
(4) Ensure that core surveillance procedures in the
conduct of SARI surveillance, including the specimen collection, are complied
with.
(5) Ensure that all SARI specimens are processed by the
sub–national laboratory housed in the hospital and reporting procedures
observed and adhered to.
(6) Ensure that preliminary investigation of SARI cases
seen at the hospital are investigated, as prescribed by the PIDSR guidelines.
d. Logistical
and Funding Support
The
operations of the Philippine National Influenza Center is among the Philippine
National Influenza Center is among the Philippine government’s responsibility
as signatory to the IHR 2005. Thus, it is important that logistic support for
its continued development, improvement, strengthening and sustainability be
provided by the Philippine government through the Department of Health and its
agencies.
(1) The budget required for the operation, continued
improvement, strengthening and sustainability of the PNIC shall be from the
Office of the Secretary of the Department of Health.
(2) The PHIC and the different sub–national laboratories
shall include in its annual line item budget the amounts necessary for its
continued strengthening and sustainability operations. This shall include (1)
wages, benefits and other personnel expenses of the laboratory, data
management, and field surveillance staff, (2) the cost of laboratory supplies
and reagents, (3) participation in influenza related meetings and training, (4)
participation in proficiency testing and quality assurance assessment both
local and international and (5) transport of representative isolates to the NIC
or to the WHO Collaborating Center.
(3) Supplemental budgetary requests may also be submitted
for funding to the DOH Epidemiology Bureau, specifically but not limited to
salary augmentation, cost of reagents, utilities in case of outbreaks,
epidemics and pandemics, and participation in proficiency testing and quality
assurance testing.
(4) Supplemental budgetary request may also be submitted
for funding to the Disease Prevention and Control Bureau, specifically but not
limited to participation in influenza–related training and conferences.
(5) Equipment acquisition and upgrade of the PNIC and the
subnational laboratories, including the provision of training for the operation
of new equipment shall be provided through the Health Facilities and
Development Bureau; any capital outlay funds available for laboratory equipment
and/or disease control subject to the approval of the Secretary of Health.
VIII. REPEALING
CLAUSE
All
other issuances inconsistent with the provisions of this Order are hereby
repealed /rescinded and modified accordingly.
IX. SEPARABILITY
CLAUSE
If
for any reason, any part or provision of this Order be declared invalid or
unconstitutional, such shall not affect the other provisions which shall remain
in full force and effect.
X. EFFECTIVITY
DATE
This
Order shall take effect 15 days upon approval.
Secretary of Health
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