risk assessment guidelines

National Institutefor Public Healthand the Environment

Risk assessment guidelinesLeon van Aerts

Scientific Committee meeting November 2008 Lisbon

18 November 2008Risk Assessment guidelinesLeon van Aerts ׀ Lisbon

2National Institutefor Public Healthand the Environment

Overview

• Need for redrafting the risk assessment guidelines• Structure of the current draft guidelines• Defining risk• Use of categories and criteria in risk assessment• Delphi method• Ranking of risks



Need for redrafting the risk assessment guidelines (1) • 97/396/JHA Joint Action replaced by Council Decision

2005/387/JHA • Aim: information exchange, risk assessment, measures of

control• More transparancy needed• Change of scope:

97/396/JHA Joint Action Council Decision 2005/387/JHA

1971 UN Convention on psychotropic substances Schedules I and II

1971 UN Convention on psychotropic substances Schedules I, II, III and IV1961 UN Convention on narcotic drugs Schedules I and III and IV



Need for redrafting the risk assessment guidelines (2)

• Conservatively revised version produced in 2007- Recommendation from previous Sci.Comm.

• review the risk assessment items related to the involvement of organised crime with an input from Europol

• numerical scoring system should not constitute a formal part of the risk assessment, but could be used as a trigger to focus the discussion; only items where severe or moderate risk ratings are discussed by the full risk assessment Committee

• risk assessment meetings could explore the viability of using small working groups and rapporteurs for each assessed domain




• Comments from current Sci.Comm.- Criminal involvement aspects- Some inconsistencies between headings for risk

assessment, technical annexes and risk assessement categories

- Further detailed remarks




• Current revision:- Introductory chapter addressing the need for the

guidelines and explaining their scope- Appropriate references to the legal framework- Clarify further the principles of risk assessment, also

including prevalence as a factor contributing to the risk at the level of the population (i.e. public health risks).

- Clarify further the headings for risk assessment.- Restructure the proposed scoring system in line with

aforementioned adaptations and clarification of it as a tool for risk assessment.



Introduction: Aim

• The principle aim of a risk assessment as described in these guidelines is to provide a scientifically sound basis for a decision whether or not a new psychoactive substance should be subjected to measures of control at the level of the European Union.

- Other options for control need to be considered as well.- The risk assessment has regard to the health and social

risks of the use of, manufacture of, and traffic in the new psychoactive substance, and the involvement of organised crime and the possible consequences of control measures.



Introduction: Legal basis (1)

• Council Decision 2005/387/JHA of 10 May 2005 on the information exchange, risk-assessment and control of new psychoactive substances

• Has regard to the Treaty of the European Union, in particular Articles 29, 31(1)(e) and 34. These articles are provisions on police and judicial cooperation in criminal matters (Title VI of the Treaty of Amsterdam) – ‘Third pillar’.

• Risk assessment described in Article 6 of the Decision



Introduction: Legal basis (2)

• Council Decision also clearly refers to the 1961 United Nations Single Convention on Narcotic Drugs and the 1971 United Nations Convention on Psychotropic Substances.

- definition of new psychoactive substances (article 3)- defining the scope (article 2)- affect the nature of the risk assessment (article 6)- can provide a basis for exclusion of a new psychoactive

substance from risk assessment (article 7)- affect the measures of control to be taken by the Members

States (article 8).• The relevance of the UN Conventions for the risk

assessment lies predominantly in indicating the factors that should be taken into account when a risk assessment is carried out.



Factors that need to be assessed

• Article 6(3): The risk assessment shall be carried out on the basis of information to be provided to the scientific Committee by the Member States, the EMCDDA, Europol, the EMEA, taking into account all factors which, according to the 1961 United Nations Single Convention on Narcotic Drugs or the 1971 United Nations Convention on Psychotropic Substances, would warrant the placing of a substance under international control.



Factors to be taken into account (1)

• Narcotic drugs: UN 1961 conv. Art 3.3.iii and 3.5): - Abuse liability and producing ill effects similar to substances

already scheduled (I and II resp. IV), or is convertible to such a substance

• Psychotropic substances UN 1971 conv. Art 2.4.a): - Able to produce a state of dependence, and CNS stimulation

or depression, resulting in hallucinations or disturbances in motor function, behaviour, thinking, perception or mood or

- Similar abuse and ill effects as substances already scheduled



Factors to be taken into account (2)

• Psychotropic substances UN 1971 conv. Art 2.4.b): - sufficient evidence that the substance is being or is likely to

be abused so as to constitute a public health and social problem

- assessment of the substance, including the extent or likelihood of abuse, the degree of seriousness of the public health and social problem and the degree of usefulness of the substance in medical therapy, together with recommendations on control measures, if any, that would be appropriate in the light of its assessment.



Principles of risk assessment

- Definition of risk- Prevalence of use- Benefits of use- Independent of legal status- Wide range of options for control- Comparison with better known substances - Quality of data- Reliability and relevance of data



Defining risk (1)

• Seriousness of an adverse effect. • Often referred to as HAZARD• Factors that increase Hazard

- Extent of personal suffering- Mortality- Irreversibility- Impact on the social environment- Impact on society as a whole



Defining risk (2)

• PROBABILITY (chance) an adverse effect (Hazard) may occur in a single user

• Aspects that determine Probability- Weight of evidence

• Theoretical vs. Actual observations• Animal data vs. Human data• Case reports vs. Epidemiological studies

- Actual figure that can be derived from observations



Defining risk (3)

• PREVALENCE of use of the substance• The larger the population that uses a substance the

greater the chance that an adverse effect may occur



Defining risk (4)

RISK = HAZARD X PROBABILITY X PREVALENCE

RISK at POPULATION LEVEL = (HAZARD X PROBABILITY) X PREVALENCE

RISK at INDIVIDUAL LEVEL = (HAZARD X PROBABILITY)



Criminal involvement

Definition: “"Organised crime" is understood to be the large-

scale and complex criminal activity carried on by groups of persons, however loosely or tightly organised, for the enrichment of those participating and at the expense of the community and its members. It is frequently accomplished through ruthless disregard of any law, including offences against the person, and frequently in connexion with political corruption”.



Criminal involvement

Main characteristics: A) It is an activity of groups of people primarily

aimed at financial gain.B) Criminal offences are committed by these

groups in a systematic way with serious consequences for society.

C) These groups are prepared to protect themselves from law enforcement, especially by means of intimidation, violence or by corruption.



Risks to be assessed – comparison with other substances

• Health risks

• Social risks

• Involvement of organised crime

• Possible consequences of control measures



Risks to be assessedCAM (The Netherlands)• Health:

- Individual health• Acute toxicity• Chronic toxicity• Dependence potential

- Public health• Extent and frequency of use• Vulnerable groups• Quality of information• Availability of substance• Quality of substance• Quality of distribution system• Reporting of incidents



Risks to be assessedCAM (The Netherlands)• Social

- Civil order and safety• Public nuisance• Violence• Impaired reaction (traffic)

• Organised crime- Regarding final product- Regarding raw materials



CAM assessments until 2007

Substance Health individual

Public health

Civil order and safety

Involvement crime

Total score Recommendation

khat small small none-small none 7,1 Education; research

Magic mushrooms none-small moderate small small 8,5

Improvement quality product and trade;

education

ketamine small-moderate

small-moderate

small-moderate none-small 8,8 monitoring

MBDB moderate-large moderate small small 10,3 monitoring

GHB small-moderate moderate moderate small-

moderate 10,9 monitoring

PMMA moderate moderate-large small moderate-

large 11,8 Control measures

4-MTA moderate moderate moderate moderate-large 12,1 Control measures



Categories to be assessedNutt et al., 2006 (ACMD, UK)



Categories to be assessed inDraft guidelines

• B Dependence and abuse potential• C Prevalence of use• D Health risks• E Social risks• F Involvement of organised crime



Delphi method

• 1st round: Individual scoring by experts on each criterion• 2nd round: Discussion of outlyers

- Difference of opinion?- Reaching consensus?- New score if needed

• Suitable for complex social and medical problems were multiple criteria are relevant



Advantages of using multiple risk scales• Comprehensive• Standardized• Transparant• Rational and scientific basis• Facilitates drug-drug comparisons• Can be repeated

- as knowledge advances - or pattern of drug use develops

• Suitable for Delphi approach



Pitfalls of using numerical scores

• Extreme risks on a single criterion are not visible in average scores

• Average or total scores can be overemphasized



Conclusion

• The risk assessment of new psychoactive substances is a complex process in which many facets need to be considered and weighed and compared with other situations. It is the task of the Scientific Committee to do this in a multidisciplinary way. The result of this process should be a scientifically sound basis for a decision on control measures.



Thank you!



Backup slides



WHO assessment

• According to UN Conventions WHO is responsible for the assessment.

• Draft Proposal for the revision of the Guidelines for the WHO review of psychoactive substances for international control [vs. 15 April 2008]

• Par. 46-60 consider the assessment process.• Reference to article 3 of 1961 Convention and article 2 of

1971 Convention• Deliberations based on critical review document, report on

the questionnaire, comments received, and information meeting



WHO critical review document (1)

• As thorough as possible• Include adequate and relevant data from medical and

abuse studies• Balanced in its presentation• Should facilitate evidence-based assessment




1. substance identification by International Nonproprietary Name (INN), chemical or other common name and trade names, other identifying characteristics, Chemical Abstracts Service (CAS) registry number;

2. chemistry, including general information on synthesis, preparation and properties;

3. ease of convertibility into controlled substances;4. general pharmacology, including pharmacokinetics and

pharmacodynamics;5. toxicology, including adverse reactions in humans;6. dependence potential;7. abuse potential;8. therapeutic applications and extent of therapeutic use;9. listing on the WHO Model List of Essential Medicines;




10. marketing authorizations (as a medicine);11. industrial use;12. epidemiology of medical and non-medical use, abuse and

dependence;13. nature and magnitude of public health problems related to abuse

and dependence;14. licit production, consumption and international trade;15. illicit manufacture and traffic, and related information;16. current international controls and their impact;17. current and past national controls;18. other medical and scientific matters relevant for a recommendation

on the scheduling of the substance.



Conclusion: What needs to be assessed? (1)• Health risks, social risks, involvement of organised

crime and possible consequences of control measures• Abuse liability and ill effects similar to UN 1961

Convention schedule I, II or IV or,• (a) ((1) Able to produce a state of dependence, and (2)

CNS stimulation or depression, resulting in hallucinations or disturbances in motor function, behaviour, thinking, perception or mood) or, similar abuse and ill effects as substances already scheduled under UN 1971 Convention and (b) sufficient evidence that the substance is being or is likely to be abused so as to constitute a public health and social problem and



Conclusion: What needs to be assessed? (2)• the extent or likelihood of abuse, • the degree of seriousness of the public health and

social problem

risk assessment guidelines

Documents

risk assessment items

principles of risk assessment

moderate risk ratings

council decision

legal basis

current sci

jha aim

involvement of organised