Responsible Practice in E-Vapour Products (EVP) Product Stewardship
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1 Responsible Practice in E-Vapour Products (EVP) Product Stewardship Tanvir Walele, MSc, ERT 11 October
2 Responsible Practice Responsible practice can be divided in to 3 areas: Pre-market product stewardship Batch release Post-market product stewardship 2
3 Pre-market product stewardship Risk assessment of ingredients & materials Performed by registered Toxicologist Device Quality Testing Stability testing: normal & accelerated Aerosol chemistry & invitro toxicology Focus on nicotine, carbonyls & metals Ingredients pharmacopeia / food grade Extractables & Leachables Particle size measurements & characterisation No CMRs / respiratory sensitizers Microbiological testing In-vitro biological testing 3
4 Responsible Practice Todays presentation Pre-market product stewardship Batch release Post-market product stewardship Focus today on batch release and post-market product stewardship - Emphasis on testing approaches and strategies 4
5 Batch Release Manufacturing Quality Process Control Source: BSI PAS 54115:2015 Vaping products, including electronic cigarettes, e-liquids, e-shisha and directly related products Manufacture, importation, testing and labelling - Guide 5
6 Batch release Traceability Traceability Device and packaging authenticity Corrective actions 6
7 Batch release Testing DFMEA CoA & CoC batch reconciliation Puff count verification Solid investment in quality and testing provides reassurance to consumers and regulators and contributes to development of the e-vapour sector PFMEA Liquid batch nicotine assay Bioburden testing Final device nicotine assay 7
8 Post-Marketing Surveillance Why is it important? In a nutshell, best estimates show e- cigarettes are 95% less harmful to your health than normal cigarettes Although All of the the evidence long-term suggests hazards thatof the e- cigarettes health risks areposed not yetbyclearly e-cigarettes defined, are e- cigarettes relatively small are probably by comparison close in the butharm we that musttheir continue use confers to studyonthe the long user term and others effects. ENDS use poses serious threats to adolescents and foetuses 8
9 Regulatory Frameworks What is pre-market & what is post-market? EUTPD2 (Article 20) Notification to contain: - List of ingredients - Toxicological data - Nicotine dosage - Production process description Nicotine containing liquid to be placed in dedicated containers with volume <10ml Nicotine containing liquid to be placed in dedicated containers with volume <10ml Liquid in tanks and cartridges is <2ml Only ingredients of high purity to be used Doses delivered at consistent levels Emission testing: Nicotine, Carbonyls & Metals UK MHRA (Medicinal License) Meet the essential requirements of Medical Device Directive 93/42/EEC (Class Iia) ISO Quality Management System Dossier to include relevant information on: - Development - Manufacturing process - Characterisation & properties - Quality control operation & requirement - Stability - Emission testing: Nicotine, Carbonyls & Metals Manufactured at sites which operate with principles of GMP Extensive safety literature review Abridged application PK study with PD assessment (VAS for nicotine) Increasing pre-market requirements depending on regulatory framework US ENDS PMTA Detailed descriptive information - Production process description - Product formulation & design - Conditions for using the product and instructions for use - Discussion demonstrating how the data contained in the PMTA is appropriate for the protection of public health Environmental assessment Scientific studies to include - Ingredient assessment - Aerosol chemistry (HPHCs & particle size) - Stability, E&L - In-vitro toxicology studies - Bridging studies - Pharmacokinetics - Exposure response - Likelihood of initiation/cessation - Abuse liability assessment - Impact to both user & bystander 9
10 Post-marketing surveillance The 4 Big Questions 1 What impact do EVPs have on consumers? 2 What impact do EVPs have on bystanders? 3 Do EVPs renormalise or act as a gateway to tobacco? 4 What is the addictiveness and health impact of nicotine? 10
11 Post-marketing surveillance Q1 Impact of EVP on Consumers Clinical Studies Registered Clinical Studies published since 2011 Outcomes investigated in these studies >100 studies registered on ClinicalTrials.gov Huge investment and research invested in clinical studies >30 scientific publications for Randomised Clinical Trials identified >10 scientific publications for Non- Randomised Clinical Trials identified - Safety and Tolerability - Nicotine PK - Smoking reduction - Subjective effects - EVP vs Nicotine Inhalator - EVP awareness, use and harm perceptions - Cardiovascular function - Evaluation of weight gain - Use amongst smokers with mental illness - Consumer behaviour & Topography - Biomarkers of Exposure & Biomarkers of Biological Effect 11
12 Post-marketing surveillance Q1 Impact of EVP on Consumers Registry Real world data Large N Observational Hypothesis generating Effectiveness Flexible, sub-studies Opportunistic or mandatory Clinical Trial Formatted data (selection criteria) Small N Usually randomized Hypothesis driven Efficacy Powered Usually mandatory 12
13 Confinement Mean ( SEM) Plasma Nicotine Concentration (ng/ml) Confinement Ambulatory Ambulatory Post-marketing surveillance Q1 Impact of EVP on Consumers Pharmacokinetic Biomarkers of Exposure Exposure response studies Registries Time (min) ECG & LFTs Vital signs Adverse events Outcomes measured Biomarkers of Exposure & Effect Haematology & Clinical biochemistry Subjective questionnaires Active: Active collection of data, registries, specific studies, AE reporting Passive: Spontaneous reports, submitted by manufacturer, healthcare professsional. Increased duration of use; artificial to real life-settings 13
![Post-marketing surveillance Q2 Impact of EVP on bystanders aerosol compounds [inhaled] compounds [released] Source; O'Connell et al.](/docs-images/75/71685883/images/14-2.jpg "Indoor Air Quality and Exhaled Breath Composition After Use of Nicotine Delivery Products. Poster presented at Society for Research on Nicotine and Tobacco (SRNT), USA, 2015. Available at www.")
14 Post-marketing surveillance Q2 Impact of EVP on bystanders aerosol compounds [inhaled] compounds [released] Source; O'Connell et al. Indoor Air Quality and Exhaled Breath Composition After Use of Nicotine Delivery Products. Poster presented at Society for Research on Nicotine and Tobacco (SRNT), USA, Available at Exhaled breath analysis shows far fewer peaks compared to conventional cigarette 14
15 Post-marketing surveillance Q2 Impact of EVP on bystanders Detected at low levels at all sampling times and substantially below respective WHO or Indoor Air Quality Guideline levels Source: O'Connell et al. An Assessment of Indoor Air Quality before, during and after Unrestricted Use of E-Cigarettes in a Small Room. Int. J. Environ. Res. Public Health 2015, 12,
16 Post-marketing surveillance Q2 Impact of EVP on bystanders No difference in the levels of nicotine detected on the surfaces before, during or after use of both the closed and open system e-cigarettes Source: O Connell et al. An assessment of nicotine levels on office surfaces before, during and after use of electronic cigarettes. In preparation for poster presentation at Society for Research on Nicotine and Tobacco (SRNT), Italy,
17 Post-marketing surveillance Q3 Does EVP act as a gateway to tobacco Two behavioural studies conducted by the UK Centre for Substance Use Research (funded by Fontem Ventures) Investigating EVPs and smoking initiation, relapse and dependency on nicotine 24,000 vapers enrolled EVPs are a roadblock to smoking initiation not a gateway EVPs de-normalise smoking, rather than re-normalise it 17
18 Post-marketing surveillance Q3 Does EVP act as a gateway to tobacco Dynamic Population Modelling Probability that never-user will come to smoking via EVPs whereas if EVPs does not exist they would still never-smoker Gateway effect P3 + P4 (P1 - P2) 18
19 Post-marketing surveillance Q4 Addictiveness & Health Impact of Nicotine Nicotine is regarded as addictive No toxicity concern Long term health risks? Nicotine is regarded as addictive EVPs meet consumers smoking-ritual needs Growing evidence that EVPs support smoking cessation No toxicity concern with nicotine in the small doses in an EVP USSG: Science is inadequate to conclude either way on nicotine and cancer Any long term risks are unknown Further long term research is required 19
20 Post-marketing surveillance Answers to the 4 Big Questions 1 What impact do EVPs have on consumers? 3 Do EVPs renormalise or act as a gateway to tobacco? 2 What impact do EVPs have on bystanders? 4 What is the addictiveness and health impact of nicotine? Consumer perception and behaviour assessment Post-market surveillance 20
21 Summary Responsible Practice in EVP Product Stewardship Pre-market product stewardship Risk assessment of ingredients & materials Device quality testing Aerosol chemistry & in-vitro toxicology Batch release Process Control Batch traceability Specification testing Post-market product stewardship Long-term health effects Impact to bystanders Abuse liability 21
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