Version 2 (29th January 1999)Alerting System for Chemical Health Threats Phase II (ASHTII)
WP5 Mechanism for Alerting and Engaging Public Health Authorities and Ministers, and capacity to post potential threats on RAS-CHEM (D3)
WP Lead Partner Organisation
Wyke S, Coleman G, Orford R, Duarte-Davidson R HPA Associate Partners
Mathieu-Nolf M, Linke JC, Nisse P CHRU-Lille
Dragelyte G, Badaras R HESC
Pelclova D GFH
Funding and disclaimer
This report arises from the project Alerting System for Chemical Health Threats Phase II (ASHTII; project number 2007210) which has received funding from the European Union, in the framework of the Health Programme. Sole responsibility for this publication lies with the authors and the Executive Agency for Health and Consumers is not responsible for any use that may be made of the information contained therein.
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iii
ACKNOWLEDGEMENTS
Department of Health, Social Services and Public Safety Northern Ireland.
Public Health Wales
Health Protection Scotland
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ABBREVIATIONS
CMO Chief Medical Officer
DHSSPS Department of Health, Social Services and Public Safety (NI)
FOI Freedom of Information
HPA Health Protection Agency
HPS Health Protection Scotland
HSSB Health and Social Services Boards (NI)
NIH National Institute of Health (Italy)
NHS National Health Service
NFP National Focal Point
PHA Public Health Agency (NI)
PHEICs Public Health Emergencies of International Concern
WAG Welsh Assembly Government
WHO World Health Organization
1 International Reporting of Health Threats 1
2 European Alerting of Health Threats 4 2.1 Programme of cooperation on preparedness and response to biological and chemical agent attacks 4 2.2 The Health Security Committee (HSC) 5 2.3 Available Rapid Alert Systems 6
2.3.1 Rapid Alert System for Food and Feed (RASFF) 6 2.3.2 Rapid Alert System for non-food consumer products (RAPEX) 6 2.3.3 The Early Warning and Response System 6 2.3.4 Rapid Alert System for Biological and Chemical Alert (RAS
BICHAT) 7
3 Developing a Rapid Alert System for Chemical Health Threats (RAS- CHEM) 9
3.1.1 Why does the EU need RAS-CHEM? 10 3.1.2 RAS-CHEM users 12
3.2 Existing alerting systems at International, European and Member states levels 13
3.2.1 The European Association of Poisons Centres and Clinical Toxicologists (EAPCCT) 14
3.2.2 Two sub-regional European Networks 15 3.2.3 The Nordic Association 15 3.2.4 The Society of Clinical Toxicology of German, Austrian and
Swiss Poisons Centres (Gesellschaft für Klinische Toxikologie, GfKT) 15
4 United kingdom 18 4.1 Specialist Public Health Protection Resources 18
4.1.1 The Health Protection Agency (England and Wales) 18 4.1.2 Public Health Wales 19 4.1.3 Health Protection Scotland (Scotland) 21 4.1.4 Department of Health, Social Services and Public Safety
(DHSSPS) 22 4.2 The current alerting process in the UK 24 4.3 National Services in the UK where an alert could be escalated from the EUPC Forum 27
4.3.1 National Health Service 27 4.3.2 Primary responders 27 4.3.3 National Poisons Information Service (NPIS) 28 4.3.4 Local Government 28 4.3.5 Intelligence Agencies 28 4.3.6 Department for Environment, Food and Rural Affairs (DEFRA) 28
5 Czech Republic 30 The Fire Brigade Rescue Corps of the Czech Republic 31
6 France 32 6.1 The French toxicovigilance system : its role in the management of toxicological alerts 32 6.2 National organisation of toxicovigilance 32
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6.2.1 Current situation 32 6.3 Evolution of the French legislation 34
6.3.1 National poison centres information system, the French-TESS 34 6.3.2 ToxAlert System 35 6.3.3 National organisation of health alert 36
7 Lithuania 38 7.1 The Health Emergency Situation Centre (HESC) 38
7.1.1 Specific functions of the HESC 39
8 Germany 40 8.1 Legal obligation and legislation 40
8.1.1 Institutions, Authorities, Ministries and Government Departments responsible for managing chemical incidents 40
8.1.2 The role German Poisons Centres in issuing a Public Health Alert 41
9 Italy 43
APPENDIX A 44 A1 Control Authorities involved in the RASFF 44
APPENDIX B 47 B1 Reporting of IHR notifiable diseases from UK to WHO 47 B2 Assessment of potential PHEICs not included in the defined list of diseases 48 B3 Provision of information to WHO about potential PHEICs not included in defined lists of diseases 49
APPENDIX A 44 A1 Control Authorities involved in the RASFF 44
APPENDIX B 47 B1 Reporting of IHR notifiable diseases from UK to WHO 47 B2 Assessment of potential PHEICs not included in the defined
list of diseases 48 B3 Provision of information to WHO about potential PHEICs not
included in defined lists of diseases 49
Figure 1: The IHR alerting structure 2 Figure 2. Bindeez™ toy beads which contained 1,4-butanediol, metabolised to GHB in humans. 11 Figure 3. Example of melamine contamination 11 Figure 4. Visual representation of RAS-CHEM and the EUPC Forum 13 Figure 5. Reebok’s heart-shaped charm bracelet distributed as a gift to its clients in 2006. 14 Figure 6: Summary of European Alerting Networks 17 Figure 7: Structure of the current alerting process in the United Kingdom 26 Figure 8: Structure of the current alerting process in the Czech Republic 31 Figure 9: Organisation of the French Toxicovigilance system 33 Figure 10: Procedure for managing toxicological alerts and requests intended to the NCCT 34
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Figure 11: Health Emergency Situations Centre 39 Figure 12: Overview of poisons centres in the Federal Republic of Germany. 41
INTERNATIONAL REPORTING OF HEALTH THREATS
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1 INTERNATIONAL REPORTING OF HEALTH THREATS
In today’s globalised economy, disease can spread far and wide via international travel and trade. A health crisis in one country can impact livelihoods and economies in many parts of the world. Such crises can result from emerging infections like Severe Acute Respiratory Syndrome (SARS), or a new human influenza such as the recent H1N1 international pandemic.
The International Health Regulations 2005 (IHR) came into effect on 15 June 2007, and impact governmental functions and responsibilities across many ministries, sectors and levels. The IHR 2005 are an international legally binding instrument in 194 States worldwide, designed to help protect all States from the international spread of disease, including public health risks that have the potential to cross borders and threaten people worldwide.
IHR (2005) require countries to report defined disease outbreaks and public health events to WHO. Building on the unique experience of WHO in global disease surveillance, alert and response, the IHR define the rights and obligations of countries to report public health events, and establish a number of procedures that WHO must follow in its work to uphold global public health security.
The IHR also require countries to strengthen their existing capacities for public health surveillance and response. WHO is working closely with countries and partners to provide technical guidance and support to mobilize the resources needed to implement the new rules in an effective and timely way.
The purpose and scope of the IHR (2005) are very broad and focus on almost all serious public health risks that might spread across international borders. Specific aim of the IHR (2005) are "to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade." Because the IHR are not limited to specific diseases, but are applicable to health risks, irrespective of their origin or source, they will follow the evolution of diseases and the factors affecting their emergence and transmission. The IHR also require States to strengthen core surveillance and response capacities at the primary, intermediate and national level, as well as at designated international ports, airports and ground crossings.
The scope includes “illness or medical condition, irrespective of origin or source that presents or could present significant harm to humans”. If a State Party has evidence of an unexpected or unusual public health event, irrespective of origin or source, which may constitute a public health emergency of international concern, they are required to provide WHO with all relevant public health information. In cases where there is insufficient information available to complete the decision instrument, a state may still keep the WHO advised through the National IHR Focal Point and consult with WHO on appropriate health measures (if required). National Health Bodies are involved in the communication of alerts and there is a WHO and European Union National Focal Point in each Member State.
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To fulfil its mandate under the IHR (2005), WHO must rapidly and consistently identify and assess events of potential international public health concern. Depending on its assessment, WHO must then inform its Member States about such threats and assist affected states in their investigation and control. Finally, in extreme and rare circumstances, the Director General may declare events to be Public Health Emergencies of International Concern (PHEIC). An effective event management process will protect international public health security by ensuring that:
• Events are detected early
• Reactions are appropriate and based on well-founded risk assessments and international best practice where the latter is established
• The international community is provided with timely and accurate information about the event
• Effective international assistance, when requested, is rapidly provided to control threats at their source, and to reduce human suffering, economic and social losses
Figure 1: The IHR alerting structure
The effective implementation of these obligations requires than an adequate legal framework is in place and according to the IHR (2005) State Parties are required to designate a National Focal Point (NFP) (a national centre, established or designated by each State Party) to be accessible at all times (7 days a week, 24 hours a day and 365 days a year) for IHR (2005) related communications with WHO IHR Contact Points. Another role of the NFP is to disseminate information to, and consolidate input from
International Community
WHO GENEVA
IHR Secretariat
WHO Euro
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relevant sectors of the administration within the country, including those responsible for surveillance and reporting, points of entry, public health services, clinics and hospitals.
The NFP has a duty to both assess events that may be Public Health Emergencies of International Concern (PHEICs) and to notify them to WHO. The majority of NFP communications are expected to relate to disease outbreaks, however, the broad scope of IHR (2005) may require the NFP to carry out activities with respect to events arising from non-communicable or unknown aetiologies, including chemical or radionuclear events. Accordingly, the required information and communication functions and capacities must be established for these areas as well as those concerning communicable disease.
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2 EUROPEAN ALERTING OF HEALTH THREATS
Each member state is responsible for the safety of its citizens and the management of emergency situations, however communicable diseases and chemical, biological radiation and nuclear (CBRN) events do not respect national borders. Threats to public health are an ongoing cause of concern for health authorities across the world and it is important to ensure a coordinated approach between EU countries for the public health management in emergency situations. To ensure that the EU is ready to face such threats, the European Commission has been working in collaboration with EU Member States to develop appropriate response strategies.
In order to improve the EU state of preparedness and better protection of EU citizens against health threats, the Commission actively cooperates with international public health partners, such as the World Health Organization (WHO), the Global Health Security Initiative, the countries of the European Economic Area and those particularly included in the European Neighbourhood Policy.
EU Member States are implementing International Health Regulations (IHR), which are legally binding regulations (see chapter 1) that have been adopted by most countries and have the aim to contain the public health threats that may rapidly spread from one country to another. In this context, the rapid alert system for chemical health threats is a supporting tool for EU Member States.
Article 152 of the EC Treaty says that a "high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities". There is various legislation1 2 3
The Commission is working to ensure that, in the event of an emergency Member States are able to react in a coordinated and more effective way. The Commission have put in place a programme and structure to identify key national personnel to enable them to achieve the best response for each Member State.
(Decision No’s 1786/2002/EC, 1350/2007/EC and regulation (EC) No 851/2004) that underpins the Commission’s mission to support and improve preparedness and response to potential public health threats.
2.1 Programme of cooperation on preparedness and response to biological and chemical agent attacks
The programme of cooperation on preparedness and response to biological and chemical agent attacks was established with the aim to coordinate and support the
1 Decision No 1786/2002/EC of the European Parliament and of the Council of 23 September 2002 adopting a programme of Community action in the field of public health (2003-2008). OJ L 271, 9.10.2002, p. 1–12. 2 Decision No 1350/2007/EC of the European Parliament and of the Council of 23 October 2007 establishing a second programme of Community action in the field of health (2008-13), OJ L 301, 20.11.2007, p. 3–13 3 Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European centre for disease prevention and control. OJ L 142, 30.04.2004, p. 1-11.
EUROPEAN ALERTING OF HEALTH THREATS
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public health/ health security preparedness and response capacity and planning of Member States against biological and chemical agent attacks.
Specific objectives of the programme are to;
• Set up a mechanisms for information exchange, consultation and coordination for the handling of health-related issues with regard to attacks in which biological and chemical agents might be or have been used;
• Create an EU-wide capability for the timely detection and identification of biological and chemical agents that might be used in attacks and for the rapid and reliable determination and diagnosis of relevant cases, in particular by building on systems already available with the aim of long-term sustainability;
• Create a medicines stock and health services database and a standby facility for making medicines and health care specialists available in cases of suspected or unfolding attacks;
• Draw-up rules and disseminate guidance on facing-up to attacks from the health point of view and coordinating the EU response and links with third countries and international organisations.
2.2 The Health Security Committee (HSC)
The Health Security Committee (HSC) is comprised of high-level representatives and officials of the EU Member States who are authorised to take decisions and commitments with respect to preparedness planning and response in case of emergency. The HSC is chaired by the European Commission and other members include officials of the Directorate General for Health and Consumers (DG SANCO) and other relevant Commission services and agencies (e.g. ECDC, EMEA). The HSC holds face-to-face meetings twice a year. Specific functions of the HSC are to;
• To exchange information on health-related threats from acts of terrorism or any deliberate release of biological or chemical agents with intent to harm health;
• To share information and experience on preparedness and response plans and crisis management strategies;
• To be able to communicate rapidly in case of health-related crises; • To advice Health Ministers and the European Commission on preparedness and
response as well as on coordination of emergency planning at EU level; • To share and coordinate health-related crisis responses by Member States and the
Commission; • To facilitate and support coordination and cooperation efforts and initiatives
undertaken at EU level and help contribute to their implementation at national level. In order to ensure a rapid and effective response by the EU to a wide range of emergencies, the Commission has put in place several early warning and rapid alert systems. These systems allow public health authorities in Member States and the Commission to receive and trigger an alert, as well as exchanging other relevant information regarding events likely to affect public health at EU Level and coordination of measures.
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2.3 Available Rapid Alert Systems
A Public Health incident may occur at any time, and early warning and rapid alert systems are in place to exchange information on incidents within the EU and neighbouring or third countries. These systems are based on an information exchange network for receiving and triggering an alert as well as exchanging other relevant information. Each of these systems covers a specific health threat field.
2.3.1 Rapid Alert System for Food and Feed (RASFF)
The Rapid Alert System for Food and Feed (RASFF) was established in 1979. The purpose of the RASFF is to provide control authorities (listed in Appendix A1) with an effective tool for exchange of information on measures taken to ensure food safety. In 2008, RASFF was recognised as a great success in preventing numerous cases of food poisoning. Most important risks of food poisoning (regarding the number of alerts) are products containing potentially pathogenic micro-organisms, foreign bodies (such as glass fragments in yoghurt), heavy metals (such as mercury in fish) and mycotoxins (EU, 2008). The Commission publishes a weekly overview of alert notifications, information notifications and border rejections1
2.3.2 Rapid Alert System for non-food consumer products (RAPEX)
.
The Rapid Alert System for non-food consumer products (RAPEX) is the EU rapid alert system for all dangerous consumer products, with the exception of food, pharmaceutical and medical devices. It allows for the rapid exchange of information between Member States via central contact points. The RAPEX system was established in 2002 and aims to prevent, restrict, or impose specific conditions on the marketing or use of consumer products which can cause a serious risk to the health and safety of consumers. The number of RAPEX notifications is constantly rising, making it a crucial tool in the area of risk prevention 2. The Commission publishes a weekly overview of the dangerous products reported by the national authorities (the RAPEX notifications) and provides information on the product, the possible danger and the measures that were taken by the reporting country3
2.3.3 The Early Warning and Response System
.
The Early Warning and Response System (EWRS) is a web-based system linking the Commission, the public health authorities in Member States responsible for measures to control communicable diseases and the European Centre for Disease Prevention and Control (ECDC), and has been in operation since 2004. EEA Countries (Iceland,
1 RASFF updates available at: http://ec.europa.eu/food/food/rapidalert/index_en.htm 2 DG SANCO (2006) Annual Report on the Operation of the Rapid Alert System for non-food consumer products (RAPEX) 2005, European Communities, Brussels. 3 RAPEX weekly overview is available at: http://ec.europa.eu/consumers/dyna/rapex/rapex_archives_en.cfm
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Lichtenstein and Norway) are also linked to the system. The EWRS authorities in each Member State form a network committee chaired by the European Commission to make legal decisions on communicable diseases.
Under Decision 2119/98/EC of the European Parliament and of the Council, and Decision 2000/57/EC (amended by Commission Decision of 28/IV/2008), Member States should inform one another and the Commission about events likely to affect public health at the EU-level. Therefore, the EWRS is frequently used for notification of outbreaks, exchange of information and discussion about the coordination of measures among players. Since its launch in 2004, the EWRS has been successfully used in a number of events such as SARS, avian influenza in humans and other major communicable diseases 1
.
The Rapid Alert System for Biological and Chemical Threats (RAS-BICHAT) is the EU Rapid Alert System used for exchanging information on health threats due to deliberate release of chemical, biological and radio-nuclear agents.
It is a web-based tool that fulfils the same purpose as EWRS (notification of confirmed or suspected events, exchange of information and coordination of measures among partners.) The system links the Commission with the designated competent authority and 24 hour operational contact points of each Member States. RAS-BICHAT is part of the Programme of cooperation on preparedness and response to biological and chemical agent attacks2 and was launched in 2002. RAS-BICHAT was established to serve all Member States, particularly the Health Security Committee members3. The overall aim of the system is to address and coordinate (together with the Commission) all preparedness and response issues relating to public health effects following the hostile use of biological and chemical agents4
.
As RAS-BICHAT only deals with chemical threats in relation to terrorist activities, the Health Security Committee has identified the need of having a warning system that
1 DG SANCO (2007). Report from the Commission to the Council and the European Parliament on the operation of the Early Warning and Response System (EWRS) of the Community Network for the epidemiological surveillance and control of communicable diseases during years 2004 and 2005 (Decision 2005/57/EC) COM 2007 121, Commission of the European Communities, Brussels. 2 Available at: http://ec.europa.eu/health/ph_threats/Bioterrorisme/bioterrorism01_en.pdf 3 “The Health Security Committee is composed of health experts from the European Union member states and the European Commission, representatives of the European Centre for Disease Prevention and Control (ECDC), the World Health Organisation (WHO), the World Organisation for Animal Health (OIE) and the Food and Agriculture Organisation (FAO)” (Source: European report, 2006). 4 DG SANCO (2001) Programme of cooperation on preparedness and response to biological and chemical agent attacks (Health Security), Commission of the European Communities Health and Consumer protection directorate-general, Luxemborg.
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would cover the public health aspects in this area. The gap will be filled by the further development of RAS-CHEM (Rapid Alert System for Chemical Health Threats) – see chapter 3 for more details.
DEVELOPING A RAPID ALERT SYSTEM FOR CHEMICAL HEALTH THREATS (RAS-CHEM)
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3 DEVELOPING A RAPID ALERT SYSTEM FOR CHEMICAL HEALTH THREATS (RAS-CHEM)
As detailed in the chapter 2 (section 2.3.1 – 2.3.4) Rapid Alert Systems are not a new concept and have been in operation since 1979, however, until recently there was no specific rapid alert system for chemical health threats (including deliberate or accidental release).
Due to growing public and government concern about the possible deliberate use of chemicals for terrorist purposes, Member States (MS) agreed the need for a mechanism to rapidly identify and circulate information about, biological and chemical terrorist events between MS health authorities and the Commission to allow for rapid response throughout the European Union (EU). As described previously systems are already in place for the rapid notification of confirmed events with biological or chemical health risks of supranational concern. However, no such system is available to disseminate information on outbreaks of chemical related illnesses and only limited data is currently available on suspected cases.
The ASHT phase 1 project was a response to the European Commission Health and Consumer Protection Directorate-General’s (Directorate C – Public Health and Risk Assessment) call for proposals to implement the priority actions defined in the 2004 work plan of the public health programme (2003-2008) (Official Journal L 60/58-70, 27.2.04). One of the priority actions for this call for proposals was to ‘explore the feasibility of setting up a surveillance system for syndromes caused by exposure to chemicals recorded by poison centres, and to detect chemicals that might be used in attacks’. Originally this was a two year project (which started on the 1st of October 2005) but was subsequently extended and ran for 32 months from the 01/10/2005 until 30/06/2008.
The purpose of the ASHT phase 1 was to develop an EU system to enable the early identification and circulation of information about poisoning cases and clusters that might be associated with the deliberate release of chemicals. The overall objective of ASHT phase I was to develop the means of establishing an early warning and syndromic surveillance system for the timely detection of unusual health events due to exposure to chemicals, exploiting poisons centres as front-line resource to detect sentinel events. The target groups for this project were poisons centres, BICHAT representatives, primary and secondary health facilities and public health departments.
ASHT phase 1 project ended in 2008 and the European Commission have funded a second phase, which will take the outputs of ASHT phase 1 forward. The ASHT phase II project has been funded for 3 years (01/10/08 to 01/10/2010).
A key objective of the ASHT phase II project is to improve national and international public health authorities’ response to potential public health threats involving chemicals in the EU. These chemical events may be of national or international concern and occur as a result of either accidental or deliberate release. The process of alerting will be facilitated by the development of an information exchange platform (European Union Poison Centres forum) that will allow EU Poison Centres and Public Health Officials to
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exchange information on chemical events. The mechanisms and strategies as to how these events are escalated to member states, the WHO and the European Commission will also be established. The Rapid Alert System for Chemical Health Threats (RAS- CHEM) is being developed to enable information about validated chemical health threats to be communicated by National Public Health Officials to other Member States, the European Commission and WHO.
The ASHT phase II project expects to deliver:
• An information exchange platform to facilitate communication between EU Poison Centres (EUPC Forum) as an integral part of RAS-CHEM.
• Established policies, mechanisms and protocols to alert National Public Health Authorities of events reported to the EUPC Forum that may require further action and reporting to RAS-CHEM. The EUPC Forum will provide National Public Health Authorities a valid interpretation of what has been reported on the EUPC Forum in a simple and easy to understand format.
• Standardised terminology to describe chemical agents and clinical effects associated with exposure or poisoning.
The RAS-CHEM system is being developed and designed to link poison centres throughout Europe and their associated Public Health Authorities and Health Ministries and will include an EUPC Forum, which will act as a web-based communication platform, with the intention to eventually link all EU poison centres, to facilitate and enable rapid information exchange (i.e. suspected poisoning events).
RAS-CHEM will include a list of chemical agents identified as public health threats and their associated health effects (symptoms and features of poisoning). It is envisaged that exposure to an ‘unknown’ chemical agent could possibly be identified by comparison of clinical effects and symptoms associated with reported to the EUPC forum.
3.1.1 Why does the EU need RAS-CHEM?
In recent years, several incidents involving various chemical agents have demonstrated a need for a rapid alert system for chemicals. A few examples of where such a system would have proved useful are outlined in this section.
In October 2007, a neurological illness of unknown aetiology emerged in Angola. WHO Headquarters (HQ) and the Regional Office for Africa (AFRO) investigated the outbreak and results showed extremely high levels of bromide in blood samples. Further investigation identified the cause as bromide contaminated table salt 1
.
1 Gutschmidt G, Haefliger P and Zilker P. Outbreak of Neurological Illness of Unknown Etiology in Cacuaco Municipality, Angola. WHO rapid assessment and cause finding mission 02/11/07 – 23/11/07.
DEVELOPING A RAPID ALERT SYSTEM FOR CHEMICAL HEALTH THREATS (RAS-CHEM)
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same category as heroin in the US, was not directly present in toy beads but analyses of samples from toy beads ingested by both children found 1,4-butanediol, which is metabolised to GHB in humans. Following confirmation, the New South Wales Poison Centre notified regulatory authorities, which lead to an international recall of the toys1
Figure 2. Bindeez™ toy beads which contained 1,4-butanediol, metabolised to GHB in humans.
. This example highlights the importance of poisons centres in raising an alert.
Example of the toys responsible for the GHB poisoning of two children in Australia in 2008, available at:http://www.brisbanetimes.com.au/news/queensland/bindeez-distributor-announces- recall/2007/11/07/1194329300123.html (accessed 23/07/09)
Another large scale poisoning event reported recently was melamine contamination of milk containing products, dairy and non dairy products as well as animal feed manufactured in China in 2007-2008. In 2008, six children died and more than 51,900 infants and young children were hospitalized for urinary tract disorders after consuming food tainted with melamine in China.
Figure 3. Example of melamine contamination
The melamine molecule and Thai officials collecting melamine-tainted snacks and food products prior to destroying them. Pornchai Kittiwongsakul/AFP/Getty images available at: http://www.theepochtimes.com/n2/content/view/8334/ (accessed 24/07/09).
1 Gunja N, Doyle E, Carpenter K, Chan OT, Gilmore S, Browne G and Graudins A. γ-Hydroxybutyrate poisoning from toy beads. MJS 2008; 188 (1): 54-55.
3.1.2 RAS-CHEM users
RASCHEM users will include National Public Health Authorities, Health Ministries, RAS- BICHAT (Rapid Alert System for Biological and Chemical Alert Threats) and WHO (World Health Organization), and will be alerted to a potential public health threat or concern by the relevant Health Agency 1
The main purpose of RASCHEM is to function as a rapid alert and early warning system for chemical health threats, and as a result will provide competent Public Health Authorities a valid interpretation of what has been reported on the EUPC Forum in a simple and easy to understand format.
. Public Health Authorities and Health Agencies will be responsible for validating events reported to the EUPC Forum, if the reported event warranted further escalation; an alert would be raised to RAS-CHEM.
Chemical incidents will be reported to RAS-CHEM whilst chemical terrorist threats will be reported to RAS-BICHAT.
1 In England, Wales and Northern Ireland the relevant Health Agency is the Health Protection Agency (HPA) and Scotland the relevant Health Agency is Health Protection Scotland (HPS).
DEVELOPING A RAPID ALERT SYSTEM FOR CHEMICAL HEALTH THREATS (RAS-CHEM)
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Figure 4. Visual representation of RAS-CHEM and the EUPC Forum
Essentially the RAS-CHEM system will comprise two parallel but compatible IT systems. RASCHEM will be used by Public Health Officials in the detection of cross border chemical health threats; this will include a number of toxic chemical agents and will be fully tested. The EUPC forum will be used by European poisons centres to communicate emerging chemical hazards and to inform the treatment of exposed individuals. The EUPC forum will feed into RASCHEM, both systems will be analogous in content and operability.
A fundamental requirement for both applications to operate successfully is to develop and introduce a standardised approach for notifying Public Health Authorities, Health Ministries and Officials.
3.2 Existing alerting systems at International, European and Member states levels
Poison centres are already linked to networks (e.g. toxicovigilance and pharmacovigilence) that are also used for alerting purposes. However, the majority of these networks are informal, such as toxicovigilance, which are informal and consist of professional associations who aim to share information and issue alerts on a voluntary basis. Some of these networks may have a national or regional focus but for most of them membership is international.
A recent example of existing poisons centres informal alerting systems was the lead contamination children’s charm bracelets sold with Reebok trainers in 2006. The UK
Rapid Alert System –Biological and Chemical Alert Threats (RAS BICHAT)
Public Health Authorities (Member States)
Validated Not
RAS-CHEM
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National Poisons Information Service (NPIS) issued an alert on the online poisons information database TOXBASE about lead contamination of 300,000 charm bracelets provided as free gifts to Reebok customers. A product recall was issued on the 23rd March 2006 following the death of a 4 year child who had swallowed the heart-shaped charm of the bracelet 1
.
Photo of the type of Reebok bracelet which caused the death of a four years old child, and was the subject of a voluntary recall by Reebok International Ltd. and the Consumer Product Safety Commission on 23rd March 2006, available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm55d323a1.htm (accessed 23/07/09)
Another example of lead contamination of was the large product recall of Mattel® toys in August and September 2007. Almost 20 million toys were recalled due to the discovery that the paint used in the toy’s contained large concentrations of lead.
In some European countries poison centres national networks have been established on a more formal basis and poisons centres are recognised in national legislation and have a legal obligation to report poisoning incidences to a central national body, for example in Germany, poisons centres report cases to the Federal Institute for Risk Assessment (BfR). As a result these networks are usually linked to higher institutions such as Ministry of Health or another government body.
More information about these different structures is provided below and summarised in Figure 6.
3.2.1 The European Association of Poisons Centres and Clinical Toxicologists (EAPCCT)
The EAPCCT is an international network of poisons centres and clinical toxicologists, members include poisons information specialists, clinical toxicologists and other professionals working in the field of clinical toxicology. The EAPCCT board have
1 Berg KK, Hull HF, Zabel EW, Stanley PK, Brown MJ and Homa DM. Death of a child after ingestion of a metallic charm – Minnesota, 2006. Morbidity and Mortality Weekly Report; 2006; 55 (12): 340- 341.
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recently begun to issue alert messages to members via its mailing list, and alerts are filtered by the EAPCCT General Secretary who decides if an alert should be escalated to members. The EAPCCT website also provides members with a private discussion forum and is another means of issuing alert messages to Poisons centres. The EAPPCT is involved in the ASHTII project.
3.2.2 Two sub-regional European Networks
In Europe, there are two recognized sub-regional networks of poisons centres: the Nordic Association of Poisons Information Centres and the Society of Clinical Toxicology of German, Austrian and Swiss Poisons Centres.
3.2.3 The Nordic Association
Poisons centres in Denmark, Finland, Iceland, Norway and Sweden form the Nordic Association. The Nordic Association aims to share experience and co-operation between Nordic countries. Communication between members is regular and mainly consists of exchanging information on products and discussions around problematic cases. Alerts can be circulated by telephone or e-mails. The Nordic association of poisons centres are a collaborating partner on the ASHTII project.
3.2.4 The Society of Clinical Toxicology of German, Austrian and Swiss Poisons Centres (Gesellschaft für Klinische Toxikologie, GfKT)
This Society includes staff from German-speaking poisons centres and professionals working in the fields of clinical, analytical or forensic toxicology. Its principal activities include data harmonization and data pooling between poisons centres, developing common protocols and standards. Members can use this society to transmit an alert by telephone or e-mail. The society of clinical toxicology of German, Austrian and Swiss Poisons Centres are also involved in the ASHTII project.
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SICAP and TOXALERT
Structure Association of professionals working in the field of clinical toxicology
Poisons centres in Austria, Germany and Switzerland.
4 poisons centres in the UK (Birmingham, Cardiff, Edinburgh and Newcastle)
10 poisons centres and 3 toxicovigilance centres, and the database TOXALERT.
9 poisons centres and the Federal Institute of Risk Assessment (BfR)
9 poisons centres accredited by the National Institute of Health.
Poisons centres in Denmark, Finland, Iceland, Norway and Sweden.
How alerts are communicated
Email Email or telephone
Publishing an alert on TOXBASE Email or telephone
TOXALERT is planned to have an ‘alert’ function. Email or telephone
Poisons centres report incidents to BfR who are responsible for issuing an alert.
Informal email or telephone communication
Email or telephone.
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Under the International Health Regulations (2005), Member States are required to designate a National IHR Focal Point (NFP) to be accessible at all times for communications with the World Health Organization (WHO) IHR Contact Point. The NFP has a duty to both assess events that may be Public Health Emergencies of International Concern (PHEICs) and to notify them to WHO.
In the wake of emergencies both natural (e.g., floods and foot and mouth disease in cattle) and manmade (e.g., 9/11 and general terrorism), the Parliament of the United Kingdom passed The Civil Contingencies Act 2004. The Act imposes legal obligations on emergency services, public health related bodies and local authorities (Category 1 responders) to assess the risk of, plan, and exercise for emergencies, as well as undertake Business Continuity Management. Category 1 responders include; Local Council Authority councils, Environment Agency, Police, Fire and Rescue Service, Ambulance Service, Health Protection Agency, Health Protection Scotland, National Public Health Service Wales, Primary Care Trusts*
The Act also places legal obligations for increased co-operation and information sharing between emergency services (e.g. Ambulance service and Police Force) and also to non-emergency services (e.g. Utility services). Non-emergency services are defined as Category 2 responders and include; Utilities (Electricity, Gas, Water and Sewerage, Public Communications Providers [both landline and mobile]), Transport Operators (Train and Bus Operating Companies), Health and Safety Executive and Strategic Health Authorities.
(England), Hospital Trusts and Port Health Authorities.
The Civil Contingencies Act seeks to manage the risk before an event and ensure the resiliency of government after an event has occurred.
4.1 Specialist Public Health Protection Resources
4.1.1 The Health Protection Agency (England and Wales)
The Health Protection Agency (HPA) is an independent organisation dedicated to protecting people’s health throughout England, Wales and to some extent Northern Ireland. The HPA is a tertiary service in Scotland. The HPA provide impartial scientific and medical advice and authoritative information on health protection issues to a broad range of stakeholders including the public, professionals and to UK government. The organisation comprises a Centre for Emergency Preparedness and Response, a Centre for Infections, a Centre for Radiation, Chemicals and Environmental Hazards, a Regional Microbiology Network as well as Local and Regional Services. The Centre for Radiation, Chemicals and Environmental Hazards has a Radiation Protection Division and a Chemical Hazards and Poisons Division (including a commissioned National
* NHS Boards in Scotland, Health and Social Care Trusts in Northern Ireland and Local Health Boards in Wales.
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Poisons Information Service), responsible for providing advice about the known health effects of chemicals, radiation, poisons and other environmental hazards. The HPA operates a 24-hour dedicated chemical response hotline.
The remit of the HPA is: protecting people, preventing harm and preparing for threats. Specific roles of the HPA include;
• Providing impartial expert advice on health protection and providing specialist health protection services
• Identifying and responding to health hazards and emergencies cause by infectious disease, hazardous chemicals, poisons or radiation;
• Anticipating and preparing for emerging or future threats
• Supporting and advising other organisations with a health protection role
• Improving knowledge about health protection through research and development, education and training.
4.1.1.1 Chemical Hazards and Poisons Division
The Chemical Hazards and Poisons Division (CHaPD) provides advice to UK government departments and agencies (England, Wales and to some extent Northern Ireland) on human health effects from chemicals in water, soil and waste as well as information and support to the NHS and health professionals on toxicology.
The strategic goal of CHaPD is to anticipate and prevent the adverse effects of acute and chronic exposure to hazardous chemicals and other poisons. Every day in Britain, serious chemical incidents occur which threaten people's health. Such potential health threats might involve chemical fires, chemical contamination of the environment, or the deliberate release of chemicals and poisons. Exposure to hazardous substances can also occur during accidents at home and work, and as a result of deliberate and malicious releases.
Guidance is available round-the-clock from medical toxicologists, clinical pharmacologists, environmental scientists, epidemiologists and other specialists. The division also advises doctors and nurses on the best way to manage patients who have been poisoned through a contract with the National Poisons Information Service (NPIS).
There are five supra-regional CHaPD teams located in; Birmingham, Cardiff, Chilton, London, and Nottingham.
4.1.2 Public Health Wales
Public Health Wales is a newly created organisation that has been established as a result of the recent NHS reorganisation in Wales. It represents the largest specialist public health resource in Wales, with its remit being the provision of resources, information and advice to enable the Welsh Assembly Government, local authorities and other NHS bodies to discharge their statutory public health functions. Public Health Wales plays a vital role in health protection in Wales, meeting its responsibilities through:
• Consultants in Communicable Disease Control and Health Protection Teams (South East, Mid & West and North Wales). Responsibilities extend beyond communicable disease control and include chemical, radiation, environmental hazards and emergency preparedness);
• Consultant in Environmental Public Health Protection (with all-Wales environmental public health protection responsibilities);
• The Communicable Disease Surveillance Centre (providing specialist advice in relation to epidemiological studies and investigations, incident management and epidemiological surveillance techniques);
• A microbiology laboratory network;
• Provision of an out of hours health protection service;
• Wider public health professionals working for Public Health Wales, but outside of the health protection discipline. This wider public health resource contributes to the organisation’s out of hours health protection service and is available in times when surge capacity is required to deal with major acute events;
• Dedicated public health communications team.
Public Health Wales has a broad range of expertise, including public health risk assessment; risk communications, public health response co-ordination, environmental epidemiology, surveillance, emergency planning and response, environmental inequalities, research and development.
In preparing for, and responding to, chemical health threats, Public Health Wales works closely with the HPA. Depending upon the nature of the chemical incident and/or threat(s), it may be appropriate and necessary for other agencies to also contribute to, and inform, the specialist public health response. Information and advice may therefore be provided by a range of partner agencies, including the Environment Agency (Wales), emergency services, local authorities, Food Standards Agency (Wales), Health and Safety Executive (Wales), Welsh Assembly Government and private agencies such as water companies.
The specialist public health resource provided by Public Health Wales is able to provide a timely response to acute incidents on a 24/7/365 basis. Should a major incident be declared, public health protection specialists will take directions initially from the emergency services (particularly fire service colleagues) and then actively contribute to the public health management of the incident (including any appropriate follow-up). For chronic or routine chemical-related issues or events, the collective specialist public health resource will provide a co-ordinated routine health protection/health gain response. In addition, public health specialists are able to provide a strategic response to support the development of relevant policy.
Closer and stronger working links have been forged between Public Health Wales and the HPA in Wales through the appointment of a Consultant in Environmental Public Health Protection. This has resulted in more effective and efficient ways of working that
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allow a closely integrated service to be delivered to those that need it wherever they are in Wales.
4.1.3 Health Protection Scotland (Scotland)
Health Protection Scotland (HPS) is a specialist Division of NHS National Services Scotland (NSS), which is a non-departmental public body accountable to the Scottish Government, responsible for providing strategic support services and expert advice to NHS Scotland.
Health Protection Scotland works in partnership with others, to protect the Scottish public from being exposed to hazards which could damage their health and to limit any impact on health when such exposures cannot be avoided. HPS works closely with other public health and related organizations in Scotland and the rest of the UK and beyond including.
• 14 local NHS Boards and their Health Protection Teams
• 32 Local Authorities; Environmental Health and other Departments
• Scottish Environment Protection Agency
• The Health Protection Agency (UK)
• National Poisons Information Service (NPIS)
HPS coordinates the surveillance and investigation of communicable diseases at national (Scotland) level. HPS also maintains surveillance of non-communicable hazard incidents associated with exposure to chemical, physical and other environmental hazards via the Scottish Environmental Incident Surveillance System (SEISS) a web based reporting system. The 14 local NHS Boards are required to report any significant public health incidents or threats to public health occurring in their local areas to HPS, for onward alerting as appropriate, including incidents fulfilling the criteria specified in the IHR.
HPS provides expert advice and support on health protection matters including risk analysis (risk assessment, management and communication) relating to microbiological and chemical hazards, bringing together expert knowledge from within and outside Scotland as necessary. HPS also advises the Chief Medical Officer for Scotland and the Scottish Government on health protection matters and assists in the development of national policy and national level initiatives.
HPS are responsible for coordinating the management of incidents and outbreaks within Scotland when these involve more than one NHS Board area, are national or supra-national (e.g. pandemic influenza) or are very unusual (CBRN). HPS also advise the Scottish Government on the strategic aspects of managing outbreaks and incidents (including bio-terrorism and deliberate release (CBRN)). HPS supports the local NHS Boards in their role as health protection advisers to local Strategic Coordination Groups
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(SCGs) set up to manage any local incident under the provisions of the Civil Contingencies Act.
HPS acts to ensure a coordinated response across Scotland by working with the Health Protection Teams in the 14 local NHS Boards and assists with maintaining adequate capacity and resilience across Scotland. HPS maintains mechanisms for the rapid dissemination of information and alerting messages to the NHS in Scotland.
HPS also provides support in the form of education and training activities for Health Protection Staff and other related fields within Scotland. HPS collaborates in a variety of research and development activities as well as Quality Assurance initiatives associated with improving health protection capability and response and improving public health outcomes.
4.1.4 Department of Health, Social Services and Public Safety (DHSSPS)
The Department of Health, Social Services and Public Safety (DHSSPS) is one of 11 Northern Ireland Departments created in 1999 as part of the Northern Ireland Executive by the Northern Ireland Act 1998 and the Departments (Northern Ireland) Order 1999.
The DHSSPS’s mission is to improve the health and social well-being of the people of Northern Ireland. The Department endeavours to do so by ensuring the provision of appropriate health and social care services, both in clinical settings such as hospitals and GPs’ surgeries, and in the community through nursing, social work and other professional services. It also leads a major programme of cross-government action to improve the health and well-being of the population and reduce health inequalities. This includes interventions involving health promotion and education to encourage people to adopt activities, behaviours and attitudes which lead to better health and well-being. The aim is a population which is much more engaged in ensuring its own health and well-being.
The Department has three main business responsibilities:
Health and Social Care (HSC), which includes policy and legislation for hospitals, family practitioner services and community health and personal social services;
Public Health, which covers policy, legislation and administrative action to promote and protect the health and well-being of the population; and
Public Safety, which covers policy and legislation for fire and rescue services
4.1.4.1 Public Health Agency (Northern Ireland)
The review of public administration (April 2009) saw a range of functions in Health and Social Care Services (HSCS) brought together to focus on improving the health and wellbeing of everyone in Northern Ireland, and resulted in the formation of the new Public Health Agency (PHA).
In the interim and until the new public health structure within NI has been clarified, the Communicable Disease Surveillance Centre (CDSC) NI will be the contact point to refer IHR and PHEIC related issues to the HPA. It is likely that the majority of events will concern communicable disease there are also provisions for chemical and radiological
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issues. As an interim solution (pending clarification of structures as a consequence of the review of public administration) CDSC (NI) will act as the Northern Ireland single contact point for all IHR issues. In terms of chemical and radiological issues CDSC (NI) will be acting outside its corporate remit as defined by the DHSSPS and outside its corporate expertise. For these issues it will seek to liaise with the PHA Director of Public Health who has statutory responsibility for such events and with the Chief Medical Officer, DHSSPS.
These arrangements will be revisited by the Director of Public Health when post-RPA health protection infrastructure has been determined.
Notifying the UK National Focal Point of an incident in Northern Ireland
• Report of PHEIC by PHA or other agency to CDSC (NI)
• The notifier together with DHSSPS and CDSC (NI) agree their assessment against the IHR criteria, and subsequent action
• CDSC (NI) notifies the HPA.
UK National Focal Point requests information on (alleged) events in Northern Ireland (within potentially very short IHR specified timescales).
• HPA routes information requests through to CDSC (NI)
• CDSC (NI) notifies DHSSPS
• CDSC (NI) (with DHSSPS authority) requests information/ action through PHA
• CDSC (NI) collates the information received and produces a report for DHSSPS
• With DHSSPS approval CDSC (NI) sends report to HPA
Dissemination of information within Northern Ireland as decided by the UK CMO and DH
• CMO/ DH authorises dissemination of information by HPA with/ without accompanying UK Government comments
• DH and HPA to jointly consider to whom information should be disseminated and how
• HPA notifies CDSC (NI)
• CDSC (NI) notifies DHSSPS and assists in development of dissemination plan. In most foreseeable circumstances this will follow the principles developed by DH/ HPA. However, local variation in terms of Health Service structures and existing dissemination mechanisms will need to be accounted for.
• Potential modes of dissemination include:
o Through on-call public health rota(s)
o Through existing CMO cascade
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o Through media using DHSSPS press office
• PHA / Trusts will assist DHSSPS / CDSC (NI) in implementation of the dissemination plan.
4.2 The current alerting process in the UK
It is not possible to devolve responsibility for notifying events to WHO to individual devolved administrations, Crown Dependencies, or overseas territories. Notifying events to WHO under IHR 2005 is the responsibility of the UK Government, because an event which needs to be considered for possible notification to WHO will not necessarily be a single incident occurring in only one place. Nor will an event (or an incident that is part of a wider event) in the territory of a devolved administration, Crown Dependency, or overseas territory necessarily engage only the responsibilities of the Crown Dependency or overseas territory. The current alerting process in the UK is represented in Figure 7.
The UK Government has designated the Health Protection Agency (Centre for Infections) as the UK's National Focal Point (NFP) and a joint protocol has been developed between the Department of Health (DH) and the HPA for the assessment and reporting of Public Health Emergencies of International Concern (PHEICs) by the NFP. The NFP has a duty to both assess events that may be PHEICs and to notify them to WHO. The majority of NFP communications are expected to relate to disease outbreaks, however within the scope of IHR (2005), PHEICs may also include events arising from non-communicable or unknown aetiologies, including chemical, biological or radionuclear events.
The UK Government welcomes any contributions the DAs wish to make to the assessment of events that occur (at least partly) within their territories. Such contributions should be provided to the HPA national focal point, and where the HPA puts an assessment to the Chief Medical Officer (CMO) for decision, the DA contribution will then be included by the HPA with that assessment.
For the HPA to be in a position to consider whether events should be notified to WHO as potential PHEICs it is essential the HPA receives information from all parts of UK, devolved administrations, Crown Dependencies and overseas territories about events that need to be considered in this category.
The HPA’s existing surveillance responsibilities already mean that the HPA receives information about events in England. The HPA already has well established contacts within England, because of its day to day involvement in health protection matters for England. Devolved administrations, Crown Dependencies and overseas territories are asked to ensure that they have arrangements in place to ensure that they alert the HPA without delay to any events in their areas that need to be assessed to decide whether they are PHEICs, and to provide a single contact point through which the HPA may route requests for information about urgent IHR issues.
It will not always be desirable to put a decision to notify an event into the public domain. The HPA will include in its Freedom of Information (FOI) publication scheme a commitment to publish information about notifications to WHO and events considered
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for notification. It will therefore be possible for Das to respond to questions by saying that information will be published in due course. Sometimes it may be necessary to release information for example, if required by Parliament or by WHO decision. Where feasible the UK Government will consult with the DA government concerned if it occurs in their territory. A DA will also liaise with UK government (where feasible) about any information regarding a notification they wish to make public.
The default HPA contact point is the Duty Doctor rota at the Centre for Infections (CfI) at Colindale, London. Individual DAs have been requested to provide a single contact point through which the HPA may route requests for information about urgent IHR issues.
The HPA have produced three specific algorithms for providing information to WHO about potential PHEICs (see Appendix B1-B3).
The Director-General is responsible for determining if the event is a public health emergency according to criteria within the IHR. At the request of the state, WHO shall collaborate in the response to public health risks and other events by providing technical guidance and assistance by assessing the effectiveness of the control measures in place, including mobilisation of international teams of experts for on-site assistance when necessary.
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Figure 7: Structure of the current alerting process in the United Kingdom
Health Protection Agency (National Focal Point)
Category 1 responders: Ambulance service Local council authorities Environment Agency Primary Care Trusts Hospital Trusts Port Health Authorities National Poisons Information Service (part of Health Protection Agency) Police Service Fire and Rescue Service Health Protection Agency Health Protection Scotland National Public Health Service Wales Public Health Agency
Local Public Health Director (Wales) Public Health
Agency (NI)
Welsh Assembly Government
Health Protection Scotland (HPS)
Intelligence Agencies (UK)
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4.3 National Services in the UK where an alert could be escalated from the EUPC Forum
4.3.1 National Health Service The National Health Service (NHS) provides healthcare to anyone normally resident in the United Kingdom and the majority of services are free at the point of use for the patient (although charges are associated with eye tests, dental care, prescriptions, and many aspects of personal care). The NHS is largely funded from general taxation (including a proportion from National Insurance payments). The UK government department responsible for the NHS is the Department of Health, headed by the Secretary of State for Health. Most of the expenditure of The Department of Health (£98.7 billion in 2008-9) is spent on the NHS.
There are four National Health Services in the UK, including;
• National Health Service (England)
• Health and Social Care (Northern Ireland)
4.3.1.1 Hospitals and A&E departments Hospital emergency departments (sometimes termed accident & emergency (A&E) department or casualty department) provide initial treatment to patients with a broad spectrum of illnesses and injuries, some of which may be life-threatening and require immediate attention. If a case involving a potential chemical health threat was referred to Hospital and warranted further investigation, the hospital would consult the National Poisons Information Service, the Health Protection Agencies (HPS – Scotland, HPA – England and Wales) or the National Health Service.
4.3.1.2 NHS Direct and NHS24 NHS Direct and NHS24 (Scotland) are national health information resources, providing expert health advice, information and reassurance to members of the public either over the telephone or the internet (website). If a suspected case or potential chemical health threat was received by either service (NHS Direct or NHS24) then the National Poisons Information Service (NPIS) would be consulted for further advice or information.
4.3.2 Primary responders As outlined in the introduction to this chapter there are legal obligations and responsibilities placed on emergency services (Category 1 responders) to plan, prepare and respond to major emergencies under the Civil Contingencies Act 2004.
Primary responders include; ambulance, fire and police services. If a potential chemical health threat was received by either service then they would alert either the National Poisons Information Service, Local and Regional services or both. In some circumstances they may report concerns directly to the Health Protection Agency (England, Wales and Northern Ireland) or Health Protection Scotland.
Department of Health, Social Services and Public Safety (NI)
Intelligence Agencies (UK)
The proposed structure of the EUPC-Form would enable poisons centres to communicate concerns at this stage in the alerting process.
4.3.4 Local Government A potential chemical health threat maybe reported to local government (e.g. local council authorities). Local government would then seek further information from Local and Regional services (England) Public Health Wales, the Public Health Policy Unit (Scotland), or the Public Health Agency (NI).
4.3.4.1 Local and Regional Services (England and Wales) and Public Health Policy Unit (Scotland) Local and Regional Services (England), Public Health Wales, Public Health Policy Unit (Scotland), or the Public Health Agency (NI), could be alerted to a potential chemical health threat by either Primary responders or local government. They would then escalate the information to the Chemical Hazards and Poisons Division of the Health Protection Agency (England, Wales and Northern Ireland). If an alert was limited to Scotland, then Health Protection Scotland would be consulted, however if a national threat was suspected, concerns would be raised and shared with the Health Protection Agency.
4.3.5 Intelligence Agencies Intelligence services include;
• MI5 – Security Service • MI6 – Secret Intelligence Service If Intelligence agencies were alerted to a potential chemical health threat it would depend on National security related issues if this information would be cascaded over to the Health Protection Agency (England, Wales and Northern Ireland) or Health Protection Scotland and up-to the Department of Health (DH), DHSSPS and RAS- BICHAT.
4.3.6 Department for Environment, Food and Rural Affairs (DEFRA) DEFRA (the Department for Environment, Food and Rural Affairs) is a Government Department linked to a number of other UK Government departments including; Veterinary Medicines Directorate, Marine and Fisheries Agency, Animal Health, Centre for Environment Fisheries and Aquaculture Science, Food and Environment Research Agency, Veterinary Laboratory Authority. Non departmental public bodies associated with DEFRA include; Environment Agency and Natural England, public corporations
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include British Waterways and others include Forestry Commission (non ministerial department) and the National Parks Authorities.
A Rapid Alert System for Food and Feed (RASFF) already operates within DEFRA and is housed in the suite of RAS systems in the European Commission. The purpose of the RASFF is to provide the control authorities with an effective tool for exchange of information on measures taken to ensure food safety. It is envisaged that if an alert was picked up by this already established rapid alerting system it would be fed-across to RAS-CHEM.
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5 CZECH REPUBLIC
The Czech Republic has one poison centre, the Toxicological Information Centre, which serves the entire population of the Czech Republic (10 million inhabitants). The poison centre is situated in the Department of Occupational Medicine of the General University Hospital and Charles University in Prague. The poison centre provides information and advice in case of exposure to toxic agents both to health care professionals and the general public. The poison centre operates 24 hours a day, 7 days a week. Simultaneously, a specialised centre for Radiation incidents is in the same location. The current alerting process in the Czech Republic is represented in Figure 8.
In accordance with the International Health Regulations (2005), the National Focal Point is based at the Ministry of Health, in the office of the Main Public Health Officer who works closely with the Department of Crisis Management of the Ministry of Health. This Department provides partial financial support to the Toxicological Information Centre; especially concerning a limited antidote stock both for the toxic and radionuclide’s exposures, however no formal alerting system links the Toxicological Information Centre to the Ministry of Health. However, exercises concerning emergency preparedness both for chemical and radiological incidents occur in different time intervals. In addition, in cases of public health concern, the Toxicological Information Centre is consulted by the Ministry of Health.
The Czech Fire Brigade Rescue Corps is the main controlling unit and a coordinator of the integrated rescue system, which unites all rescue system components for performing rescue and clearing works in a state of an emergency or crisis. The Fire Brigade Rescue Corps of the Czech Republic cooperates with other components of the integrated rescue system (paramedics, police, army), as well as with the administration, state and local authorities, legal and physical entities, non-profit organizations and civil associations. At present, the Fire Brigade Rescue Corps of the Czech Republic also plays the main role in the state’s preparedness for emergency situations. In 2001, the Czech Fire Brigade Rescue Corps was integrated with the Head Office for Civil Protection. The Corps is responsible for the protection of citizens in a similar way as in some other European countries. The Fire Brigade Rescue Corps of the Czech Republic deals with fire prevention, crisis management, civil emergency planning, citizen protection and integrated rescue system.
The National Focal Point and the Department of Crisis Management would be consulted if there was an incident involving chemicals of public health concern. When contacting or prior to contacting the National Focal Point information would be obtained from various sources including:
• Fire Rescue Service 24h
• Department of Crisis Management
• Toxicological Information Centre 24h
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Figure 8: Structure of the current alerting process in the Czech Republic
Ministry of Health
Antidotes Stock (toxic chemical agents and radionuclide exposures
Main Public Health Officer - National Focal Point
Department for Crisis Management
Corps of the Czech
of Public Health
6 FRANCE
6.1 The French toxicovigilance system : its role in the management of toxicological alerts
Toxicovigilance could be defined as the surveillance of the toxic effects of a product, a substance or a mixture on human health. The toxicovigilance system works as a surveillance system: it collects data continuously with the aim of alerting, preventing and providing information on the occurrence or consequences of toxic events to public authorities and public. The toxicovigilance system works as a vigilance system : it monitors previously unknown or unrecorded health events possibly associated to environmental factors.
Finally, toxicovigilance draws on toxicological and epidemiological assessment and is deeply involved in surveillance, vigilance and alert in environmental health, as chemical exposure.
6.2 National organisation of toxicovigilance
6.2.1 Current situation
Currently, the French toxicovigilance system is essentially based on a network of 10 Poison control and toxicovigilance centres (PCC) and 3 Toxicovigilance centres (TVC), located throughout France under the responsibility of the Ministry of Health. PCC and TVC face two missions according to the public health code : 1) they provide by phone a free 24/7 toxicological expertise, on acute or chronic risks to anyone who call (public, health professionals or administrations) ;
2) they collect environmental and medical data providing from people queries or other medical networks (for example, emergency or intensive care units), and develop specific medical networks on toxicovigilance topics (lead poisoning in children, carbon monoxide poisoning, exposure to chemicals during pregnancy, etc.).
Note that the 3 TVC only respond to health professionals or administrations in business hours. All information on products and health events collected by the PCC is recorded in a national specific information system, named the French-TESS (Toxic Exposure Surveillance System)1
Since 2004, the coordination of the toxicovigilance system has been provided by the French Institute for Public Health Surveillance (InVS)
. Members of the PCC or TVC on call can log on instantaneously to this database in order to record new files and query on details of products of exposure. The French-TESS also allows for toxicological and epidemiological studies ; this system is described in part II.
2
1 In french : Système d’information des centres antipoison - SICAP
as part of the National
2 In french : Institut national de veille sanitaire - InVS
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Figure 9: Organisation of the French Toxicovigilance system
.
National Coordination Committee for Toxicovigilance (NCCT) French agency for food safety (Afssa), French health products safety agency (Afssaps), French agency for occupational and environmental health safety (Afsset), PCC, French ministry of Health (DGS), InVS,
Agricultural social mutual fund (MSA)
Operational Unit of the NCCT (Executive Board) French agency for food safety (Afssa), French health products safety agency (Afssaps), French agency for occupational and environmental health safety
(Afsset), PCC, French ministry of Health (DGS), InVS
Working groups of the NCCT • Drugs
• Phytopharmaceutics
• Chemical products
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Figure 10: Procedure for managing toxicological alerts and requests intended to the NCCT
6.3 Evolution of the French legislation
A French law adopted in July 2009 strengthens the role of national coordination of toxicovigilance by the French Institute for Public Health Surveillance (InVS). Furthermore, health professionals are required to declare poisoning cases which they know to PCC; industrials are compelled to declare qualitative and quantitative compositions of dangerous mixtures to PCC.
6.3.1 National poison centres information system, the French-TESS
The French-TESS has been operational since 1999 and is currently used by all PCC. This system has been confirmed by an order of the ministry of health dated of June 2002 the 18th.
French-TESS is composed of:
1 FND-TE : Base Nationale des Cas d’Intoxication – BNCI
located in the Paris PCC. This database includes data on poisoning and exposure cases recorded during the usual activity of the PCC ; this database contains at the present time, more than 1.6 million cases ;
Emission – Transmission Alerts and requests
Reception – Registration Forwarding to the operational unit
Examination, reformulation, Validation
Operational unit of the NCCT (executive board)
NCCT – scientific and administrative desk (InVS)
Notice Working groups
• The French national database of Substances and Products1
Every exposure in the French national database of Toxic Exposures is linked to one or more products registered in the French national database of Substances and Products. PCC staffs can upload information from these databases to evaluate (for the emergency response) the risk for the patient.
located in the Nancy PCC. This database includes validated information and composition on more than 200 000 agents (substances, mixtures, drugs) provided by public who called and by manufacturers. Confidential information on the composition of products is transmitted according to an article of the public health code (when, following an intoxication, the PCC ask the industrial) or thanks to voluntary declarations of industrials to PCC. With the recent law, industrials would be obliged to transmit this information to PCC for dangerous mixtures in the 30 days after the release on the market.
French-TESS is continually enriched: for example, information are imported from other databases like drugs database of the French health products safety agency or industrials products via a quite new web system of declaration. PCC also import intoxication cases from emergency, other hospital services and all notifications to toxicovigilance system. A new version of this information system is in progress using secured web technology for better ergonomics and ability to share patient files between PCC.
French-TESS is overall the essential tool for toxicovigilance. A Decision Information System, based on the French-TESS, provide complete and easy ways to analyse the full databases (except personal data), with a daily update. PCC also establish activity reports, multi-criteria queries, studies on products associated with poisoning cases and toxicovigilance surveys. All requests of the NCCT are associated with queries on French-TESS by the way of the Decision Information System. Moreover, it is also projected to elaborate an early detection alert system on French-TESS / Decision Information System based on statistical analyses of the number of exposure cases by class of agents or by agent (quite similar to the American NPDS database).
6.3.2 ToxAlert System
ToxAlert is a secured website developed by French Poison Control Centres at the request of the French Ministry of Health in order to manage toxic alerts and for toxicovigilance surveys. It could be considered as a collaborative website for toxicovigilance management.
To achieve these objectives, ToxAlert has two main features: a content management system and an e-form defining and generating system. Each toxic alert or toxicovigilance survey has a dedicated space in the website. User rights are managed for each space: administrator, expert, contributor, reader. The content management system allows users (except for readers) to create or upload files in a space: news, texts, FAQs, pictures, galleries and links. Each file is submitted to referral experts and
1 FND-SP : Base Nationale des Produits et Compositions – BNPC
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published only if validated. All appointed users of a space can then access the pool of validated files.
ToxAlert also allows e-forms to be defined, generated and published in the website. All completed e-forms are immediately available for authorized users; Epidemiologic and statistical analyses can be performed on the data at any time.
The National Coordination Committee for Toxicovigilance uses ToxAlert to share data and files concerning current national toxic alerts and surveys, and to collect data about selected toxic exposures. All committee documents (meeting reports, announcements, e-mails, survey results) are also available on ToxAlert.
In a near future, the use of ToxAlert will be extended to regional toxicovigilance networks. Another project would be to connect ToxAlert with the current national PCC database to inform physicians about a related survey as they record a specific case.
ToxAlert is a useful tool for PCC and French toxicovigilance networks.
6.3.3 National organisation of health alert
6.3.3.1 Toxicological alert
The existing alerting system is initiated by PCC and the Department of Emergency Preparedness and Response of the Health General Directorate (DGS) - French Ministry of health. In case of a toxic event detected by PCC, ministries or agencies that could have significant public health impact, this signal is sent to DGS by phone and email. Alert information will then be transmitted by the DGS through email and its website DGS-Urgent (https://dgs-urgent.sante.gouv.fr/).
French Institute for Public Health Surveillance (InVS) is specifically mandated for launching health alert to the Minister for Health. Accordingly, InVS provides a 24/7 on call duty to health professionals and administrations. Contact for emergency requests is: alerte@invs.sante.fr. Furthermore, the French Institute for Public Health Surveillance (InVS) has provided since 2005 an email address in case of toxicological alerts: alerteTV@invs.sante.fr.
The ministry of Health has initiated since 2003 a national on-call duty to support toxicological risk assessment (chemical accident, chemical terrorism attack) and provide a real-time specific expertise. Senior toxicologists are on call 24/7 to respond to health ministry or its agencies in such cases.
6.3.3.2 General national health alert system
The Operational Public Health Centre is a functioning centre established within the Department of alert, response and preparedness of the Ministry of Health. It is accessible at all times (24/7) and has the ability to collect all public health of national and international concern. While the vast majority of events will relate to communicable disease outbreaks, it is important to note that this centre has a broad scope of activities in respect of events arising from non-communicable or unknown aetiologies, such as chemical or radiological.
This Centre has also been designated as National Focal Point for the implementation of the International Health Regulations (IHR). Mandatory functions of the NFPs include : (1) sending to WHO IHR Contact Points urgent communications concerning IHR (2005) implementation ; and (2) disseminating information to, and consolidating input from, relevant sectors of the administration within the country, including those responsible for surveillance and reporting, points on entry, public health services, clinics and hospitals. By the Early Warning and Response System (EWRS) network and other RAS (Rapid Alert System), this centre sends information to the European Commission and other Member States.
Other activities of the Department of alert, response and preparedness include the establishment and maintenance of all national public health emergency response plans, the ability to assess all reports of urgent events with other public health agencies and to rapidly determine the control measures required to manage any urgent public health alert.
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7 LITHUANIA
In Lithuania there is only one poison centre (Lithuanian Poison control and Information Centre) which is situated within the Health Emergency Situation Centre (HESC). The Lithuanian HECS forms part of the Lithuanian Ministry of Health.
The Lithuanian poison centre provides information and advice to health care professionals and the general public in event of poisoning incidents (either accidental or intentional) 24 hours a day, seven days a week. If information received by the poison centre appears to be of national public health concern (e.g. pharmacovigillance) the HESC is officially notified (according to mandatory procedure). The alert would be escalated up from the poisons centre, to the HECS who would also inform the Ministry of Health. The HESC is the National Focal Point for Lithuania according to the International Health Regulations 2005.
7.1 The Health Emergency Situation Centre (HESC)
The HESC is a state funded institution that is accountable to the Ministry of Health and is responsible for undertaking the administration and management of public health functions. The structure of the HESC can is represented in Figure 11. The Director of the HESC is a member of the Health Security Committee (Health and Consumer Protection Directorate-General, European Commission), and is also a member of NATO SCEPC Joint Medical Committee. Representatives of HESC are also members of sections of Health Security Committee and their working groups.
LITHUANIA
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Figure 11: Health Emergency Situations Centre
The HESC is involved in the coordination of preparedness of institutions and National Health Care Systems to work in cases of crisis and emergency. The HESC is also the National Focal Point and National Coordination Centre according to the International Health Regulations 2005 (since 2008). The HESC also houses the poisonings control and information bureau, coordinates the activities of ambulance dispatch centres and manages the state medical reserves.
7.1.1 Specific functions of the HESC
• Organisation and implementation of activities of Emergency Management Centre for the Ministry of Health
• Act as the National Focal Point and health emergency contact point (24 hours/ 7 days a week) for RAS-BICHAT, EWRS and IHR reporting responsibilities.
• Preparation of legal acts, emergency planning, prepareness and response and producing guidelines for the effective management of medical and natural disasters.
• Responsible for organising training events (e.g. exercises, conferences and seminars) and disseminate information to the general public.
• Advice and scientific consultation is provided by the Poisonings Information and Control Bureau (service available 24 hours a day/ 7 days a week).
Ministry of Health
Health Emergency Situations Centre (embedded within the Ministry of Health)
Administration
Storage of medicines of the Ministry of Health
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8.1 Legal obligation and legislation
In Germany, the Act on the Protection Against Hazardous Substances (Gesetz zum Schutz vor gefährlichen Stoffen) or ‘Chemicals Act’ as last amended by an Act of 2 July 2008 (Bundesgesetzblatt I, 1146) aims to protect man and the environment from the harmful effects of dangerous substances and preparations, in particular to identify them, avert them and prevent their occurrence. It includes the responsibility of German federal states to establish and maintain poisons centres. This legislation is mainly directed to routine handling of chemicals but not to the management of chemical emergencies.
8.1.1 Institutions, Authorities, Ministries and Government Departments responsible for managing chemical incidents
Germany consists of 16 federal states. According to the German constitution federal states are responsible for most aspects of administration, e. g. health care, police and education. Federal states have their own legislation which means that the rules for the management of incidences may differ.
On the other hand, the federal government is responsible for providing guidelines and frames to harmonize administrational actions, facilitate cooperation of federal state administrations, and provide European and international contact points.
There are several institutions and ministries who would be involved in and responsible for response to health threats within the Federal Republic of Germany.
Management starts on a local level of authorities and service, including
• Police
• Local government bodies
If the management of the event exceeds the ability of local forces, an incident of disaster (Katastrophenfall) is declared and help is provided from other parts of the federal state. Under these conditions the following authorities are involved:
• Federal State Ministries of the Interior
• Federal State Ministries of Health
• and adjunctive authorities
If the problem requires resources that are in excess of those available from the federal state authorities then the German Joint Information and Situation Centre (Gemeinsames Melde- und Lagezentrum von Bund und Ländern, GMLZ) at the Federal
GERMANY
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Office of Civil Protection and Disaster Assistance (BBK) would be responsible for coordinating help from other Federal states or EU member states.
Other Federal Ministries and institutions that could be involved include;
• Federal Ministry of the Interior
• Federal Ministry of Health
• Federal Ministry for Food, Agriculture and Consumer Protection
• Federal Institute for Risk Assessment (BfR)
• Federal Office of Consumer Protection and Food Safety (BVL)
Such Federal Ministries and Institutions are involved if specialised expert judgement is required, or if international information exchange has to be performed. These Ministries and Institutions provide the national focal points for European and international alert systems.
Due to the number of Institutions and Ministries involved in coordinating response to different public health threats in Germany, well defined mechanisms for raising an alert about potential public health threats do exist. Poisons centre may be involved in the early detection of an event.
8.1.2 The role German Poisons Centres in issuing a Public Health Alert
Traditionally, the role of poisons centres was restricted to medical advice in individual poisoning. Since the 1990 revision of the Chemicals Act, the role of German poisons centres has been expanded to include toxicovigilance activities.
Poisons centres (Information and Treatment Centres for Poisonings) are officially mentioned in section 16e of the Chemicals Act. Today, the Federal Republic of Germany has nine poisons centres. Different Ministries in the federal states throughout the German Republic are responsible. Figure 12 summarizes the geography of German poisons centres (PC), the federal state and ministry that are responsible for them.
Figure 12: Overview of poisons centres in the Federal Republic of Germany.
Poisons Centre Responsible for State(s) Ministry responsible for
Poisons Centre
Ministries for Social Affairs
Ministries for Social Affairs and Health
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Berlin Berlin, Brandenburg Senate of Health
Mainz Hesse, Rhinel