The supply chain and good housekeeping for medicines Flashcards
What must the pharmacist ensure
they purchase pharmaceuticals of good and reliable quality from safe sources
that supplies are available at the point of need
that there is safe storage and routes of supply
what is the supply chain
The chain from manufacturer to patient (via wholesaler, distributor, pharmacy and healthcare professional)
What are the risks of the supply chain
Risks at every stage of the chain
Stored incorrectly
Wrong product sent
Delays
Licensing problems
Potential risks to patients
Stored incorrectly so does not work properly
Counterfeit so no drug at all or a different drug
Delay/ shortages so patient is without medicines.
European Legislation
October 2001- Regulation 2309/03 established a central authorisation process for Licensing of human and veterinary products and the EMEA (European Medicines Agency) was established
European Law was established in UK from November 2005 (Regulation 726/2004)
How are medicines licensed in the UK and by who?
Medicinal products made in the UK must be made on a site which holds a ML
Manufacturers Importers Licence (MIL)
allows manufacture, assembly and/or packaging of imported medicinal products
allows wholesale dealing of medicinal products imported from outside the EU
Marketing Authorisation
A licence (marketing authorisation) is needed before a product can be placed on UK market
Licence granted by MHRA
Licence sets out indications, dosage etc
Cosmetics and food supplements do not require a licence
What is a specials
Manufacturers Specials Licence (MS) allows the holder to manufacture unlicensed medicinal products or to import unlicensed medicines from outside the UK
what is a parallel import
UK parallel import licensing scheme allows medicinal products authorised in other EU member states to be marketed in the UK provided there are no therapeutic differences from the equivalent UK products
Legislation existed since 1984- major impact on UK costs of medicines
The cold chain, what do we mean about it and what are the risks
Ensuring that medicines needing to be refrigerated are not exposed to temperatures at which they may degrade or denature
Risk of damaged medicines is greater than using no medicine!
May cause harm or may result in no protection where this is expected
Storage in fridges
Refrigerators in pharmacies should be measured continuously
Maximum and minimum temperatures measured and recorded daily
Insulated containers can be used for small volume cold chain goods
Vital that products damaged by freezing are prevented from coming into contact with ice packs
Wholesale Dealers Licences (WL)
Required for anyone wishing to wholesale deal medicinal products in the EU
Full WL allows holder to wholesale deal P, POM and GSL medicines
A GSL licence allows the holder to wholesale deal GSL medicines only
MHRA administers licences
Counterfeit Medicines
WHO - spurious/falsely-labelled/falsified/counterfeit (SFFC) medicines as medicines that are deliberately and fraudulently mislabelled w.r.t. identity and/or source
Found everywhere in world
Greatest in regions where regulatory and enforcement systems for medicines are weakest
Lipitor-2005
70 counterfeit packs of Lipitor 20 mg discovered
2 separate licensed wholesalers- one parallel trader one not
Parallel trader had imported from outside EU (illegally) and passed to other wholesaler
Counterfeit Lipitor 40mg also found in Holland
Internet Pharmacies
All UK pharmacies must be registered with the GPhC
Supply of medicines via the internet is a risk and genuine Internet pharmacies will display the logo and registration number
Shortages - reasons
Manufacturing problems
Supply and demand problems
Raw material problems
Regulatory problems
Weakness of the pound (£)
Brexit
