MHRA information update on 7^th January 2008   

 

The Medicines and Healthcare products Regulatory Agency has announced tighter controls for pseudoephedrine and ephedrine, will become law from 1 April 2008. Pseudoephedrine and ephedrine are contained in some nasal decongestants in cold and flu remedies, This follows public consultation in the light of reports of misuse of these medicines in the manufacture of the Class A drug methylamphetamine (crystal meth).

 

The tighter controls announced by MHRA are:

·         Pseudoephedrine and Ephedrine containing medicines will be replaced by smaller packs of 720mg (the equivalent of 12 tablets of 60 mg or 24 tablets of 30mg)

·         The status of products containing pseudoephedrine and ephedrine will be reclassified from pharmacy only to prescription only (POM) except for the packs detailed above

·         There will be a limit to one pack only per customer

 

Updated guidance from the Pharmaceutical Society of Northern Ireland January 2008

Pharmacists should be extra vigilant in the supply of these products to the public. Pharmacists must work to effectively reduce their stock levels without adding any increased risk to the public.   Where there is any doubt on the validity of a sale then the sale should be declined and other products recommended in their place.  

Pharmacists should be aware of the practice of obtaining large quantities by using a group of persons to make multiple single purchases in an area [smurfing].

Where inappropriate usage is evidenced this should be reported to the Medicines inspectorate or the Society or an appointed person within the Area Health Boards

·         One pack per sale

·         Pack size to be a total of 720mg of pseudoephedrine

·         Personal supervision [sale] by the pharmacist

·         Written SOP in each Pharmacy for these products

·         Governance to be established for sale by a qualified person [non pharmacist]

·         Records to be kept [optional]

·         Identification required for sale [optional]

Useful contact numbers

Pharmaceutical Society NI   02890326927

Brendan Kerr MPS    brendan.kerr@psni.org.uk