OVERVIEW Threats and Hazards Identification and characterization of - PowerPoint PPT Presentation

Chemical and Radiation OVERVIEW Threats and Hazards Identification and characterization of the clinical toxicology of novel psychoactive substances (NPS) by laboratory analysis of biological samples from recreational drug users. Short title Identification Of Novel psychoActive substances (IONA)

Chemical and Radiation IONA Study Threats and Hazards Overview National Poisons Information Service Clinical data NHS Hospitals • Edinburgh from cases of • Bart’s, London • Newcastle suspected NPS • Blackpool • Birmingham exposure • Cardiff • Cardiff • Edinburgh • Liverpool HPRU Newcastle • London Hospital • Newcastle • Laboratory analysis • Northumbria • Data processing • North Manchester NHS Toxicology labs • Plymouth Samples and • Wansbeck • Southport & Omskirk clinical data • Birmingham • St Georges, London from patients • Cardiff • St Thomas’, London with severe Forensic Toxicology labs NPS toxicity • • ..more to follow Scottish Police Authority Data on samples (Edinburgh) positive for NPS Samples for identification of NPS

Chemical and Radiation IONA Study Threats and Hazards Overview Identify trends in enquiries to the NPIS Further develop methods of screening, (telephone and internet) relating to NPS analysis and quantification for and characterize and monitor the new/emerging NPS in biological samples epidemiology of reported exposures (urine, oral fluid and blood) Identify trends in the numbers of Analyse samples from patients with samples positive for NPS as identified in acute severe toxicity relating to NPS to participating NHS laboratories identify responsible agents Develop sophisticated mathematical Link the presence of analytically models for analyzing NPIS and toxicology confirmed NPS exposure with the toxic laboratory data effects experienced

Chemical and Radiation IONA Study Threats and Hazards Overview Study 4. Collection of samples for research purposes from people attending participating emergency departments (Post amendment 1) Study 4 Inclusion criteria Exclusion criteria   Patient with suspected novel Refusal of consent  psychoactive substance exposure Absence of severe toxicity   Presence of severe acute toxicity Children and young people <16 y  (See text) Samples collected for investigation of  Patient consent (immediate or suspected non-accidental injury retrospective)

Chemical and Radiation Threats and Hazards IONA Study Recruitment

Criteria for severe toxicity Chemical and Radiation Threats and Hazards (present at any time after exposure) (Post amendment 1)   Fever > 38.5 o C Acidosis (arterial or venous pH < 7.35 or  bicarbonate < 20 mmol/L) Clinically important hypothermia   Severe electrolyte or fluid disturbances Glasgow coma scale < 8 a   Hypoglycaemia (<1.7 mmol/L) ITU/HDU/CCU admission   Methaemoglobinaemia (>50%) Respiratory insufficiency   Tachycardia > 140 /min Requirement for intubation and ventilation   SBP > 180 mmHg Seizures   SBP < 80 mmHg Hallucinations/psychosis   Acute kidney injury b Extreme agitation   Creatine kinase activity raised (> 1000 IU/L) Severe or prolonged (> 24 h) behavioural  disturbance ALT/AST activity > 300 IU/L   Arrhythmia PT > 15 s or INR > 1.3   Chest pain or ECG evidence of cardiac ischaemia Death  Poisons Severity Score 61 of 3 (Severe) c or myocardial infarction  Other severe manifestations of toxicity, as determined and justified by the investigator a In the absence of likely alternative causes (e.g. severe alcohol intoxication, use of sedative drugs etc). b Defined as a rise in serum creatinine of ≥26 micromol/litre within 48 hours, a 50% or greater rise in serum creatinine known or presumed to have occurred within the past 7 days, or a fall in urine output to less than 0.5 ml/kg/hour for more than 6 h 63 c Criteria for PSS 3 relevant to recreational drug use include abnormal chest Xray with symptoms, generalized paralysis, blindness or deafness

Chemical and Radiation Study website Threats and Hazards http://www.ncl.ac.uk/hpru/research/neuro/nps/

Chemical and Radiation Participant information sheet Threats and Hazards

Chemical and Radiation Consent form Threats and Hazards

Chemical and Radiation Consultee information sheet Threats and Hazards

Chemical and Radiation Consultee declaration form Threats and Hazards

Consent form (person previously included Chemical and Radiation Threats and Hazards when they did not have capacity

Consent form (person previously included Chemical and Radiation Threats and Hazards when they did not have capacity

Chemical and Radiation Data provided Threats and Hazards • Clinical records retained by the local researcher. • Information passed on to the research team in Newcastle will include – study number – the age, sex and postcode (first 4 digits) of the patient – nature and timing of the exposure – timing of sample collection – recorded clinical features (structured data collection form). – The great majority of samples and data will be provided with consent – there will be a small number of samples collected without consent from adults with incapacity by means of appropriate declarations from consultees (England and Wales)

Chemical and Radiation Threats and Hazards

Chemical and Radiation Case report form Threats and Hazards (Page 1)

Chemical and Radiation Data collection sheet (Jan 2016 Version) Threats and Hazards (page 1)

Chemical and Radiation Data collection sheet (Jan 2016 Version) Threats and Hazards (page 2)

Chemical and Radiation Threats and Hazards

Chemical and Radiation Contact details Threats and Hazards • Simon Thomas (CI) • Tel 0191 2824642 • email simon.thomas@ncl.ac.uk