NO SMOKE... BUT PLENTY OF FIRE...
As a new report from the University of Pittsburgh Medical Centre in Pennsylvania highlights the fact that vaping may lead to ‘broken bones in even minor falls’, the Medicines and Healthcare products Regulatory Agency has published clear guidance to support bringing e-cigarettes to market as licensed therapies…
T
he publication of the ‘Guidance for licensing electronic cigarettes and other inhaled nicotine-containing products as
medicines’ report by the Medicines and Healthcare products Regulatory Agency (MHRA) has certainly created some surprise among healthcare professionals.
The report, which provides further details on the steps required to license an e-cigarette as a medicinal product and how to achieve a licence, will, if successful, potentially allow safe and effective products to be made available for prescription, for tobacco smokers who wish to quit or reduce smoking.
According to the MHRA, as stated in the Department of Health and Social Care 2017 Tobacco Control Plan, the evidence is clear that e-cigarettes are less harmful to health than smoking tobacco.
E-cigarettes regulated as medicines may be made available in strengths and volumes greater than those permitted under the TRPR (ie, containing more than 20 mg/ml nicotine, more than 2 ml for single use cartridge/disposable products or more than 10 ml for refill containers).
Finished product (drug product) According to MHRA, a description of the product, together with details of the composition of the formulation should be provided in the dossier with details of the development and manufacture of the product. Where applicable, evidence of CE/UKCA marking, which is required by the applicable UK legislation on medical devices should be provided. For example, this would be required for e-cigarettes where the ‘cigarette’ device either contains cartridges of nicotine which can be replaced or if the device can be refilled with nicotine solution.
The finished product should be controlled by appropriate specifications. Controls would include: • ensuring the levels of nicotine meet recognised pharmaceutical standards (for example, 95.0 to 105.0 per cent of the declared content) throughout the product shelf-life
• limits on impurities to ensure they are controlled at safe levels throughout the product shelf-life
• evidence that the product consistently delivers the correct dose of nicotine during use and
26
scottishpharmacist.com
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47
