Implementation Date Announced For Tighter Controls On Nasal Decongestants, UK
This follows a public consultation (MLX 343) initiated by the MHRA on proposals to amend legislation to make the sale and supply of products containing more than 720mg of pseudoephedrine and 180mg ephedrine subject to a prescription, in the light of reports of misuse of these medicines in the manufacture of the Class A drug methylamphetamine (crystal meth).
Dr. June Raine, Director of Vigilance and Risk Management of Medicines at the MHRA, said "The MHRA is introducing these measures as promptlyas possible to protect the public health. All stakeholders are working together to ensure the controls are effective and an Expert Group is carrying out a programme of work to monitor the situation."
Notes:
1. The outcome of consultation was recently considered by the Commission on Human Medicines (CHM) and the Commission advised the MHRA to proceed with the amendments to the law by 1 April 2008 in order to underpin their previous recommendation that large packs of pseudoephedrine and ephedrine should be replaced by smaller packs of 720mg (the equivalent of 12 tablets/capsules of 60 mg or 24 tablets/capsules of 30mg) and a limit to one pack per customer.
2. In considering the outcome of the consultation the CHM noted that there is now believed to be four incidents in England and Wales of crystal meth manufacture using OTC medicines containing pseudoephedrine/ephedrine.
3. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone - the public and healthcare professionals as well as the industry - to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action. http:// www.mhra.gov.uk
4. The responses to the public consultation are available on the MHRA's website.
http:// www.mhra.gov.uk
Punerea în aplicare data anunþului Pentru mai stransa controalele privind nazale Decongestants, Marea Britanie - Implementation Date Announced For Tighter Controls On Nasal Decongestants, UK - articole medicale engleza - startsanatate