Pharmacy law and ethics -classification of medicines

Which legislation controls the sale and supply of medicines?

Human medicines regulations (HMR 2012)

Which act controls controlled drugs?

Misuse of drugs Act 1971 and misuse of drugs regulations 2001

What is a marketing authorisation (MA)

A license allowing a medicinal product to be sold or supplied

What does an MA specify?

Legal classification, indication, dose, route and restrictions

What are the 3 legal classifications of medicines?

GSL, P and POM

Where can GSL medicines be sold?

In registered retail premises that can be closed too exclude the public

How do you identify a GSL medicine

It has an MA and is not classified as a P or POM

Where must a P medicine be sold?

In a registered pharmacy

How must a P medicine be stored?

Not accessible for self-selection

What is a POM?

A medicine that requires a valid prescription or legal exemption

Who can prescribe POMs?

Doctors, nurses, nurse prescribers, supplementary and independent prescribers

what is the maximum GSL pack size for paracetamol or aspirin tablets?

16 tablets

What is the maximum P pack size for paracetamol or aspirin tablet?

32 tablets

What is the maximum total quantity that can be sold?

100 tablets (96 in practice)

What is the maximum pseudoephedrine supply per transaction?

720mg

What is the maximum ephedrine supply per transaction?

180mg

Can pseudoephedrine and ephedrine be sold together?

No

Who can administer injectable medicines?

Practitioners or those acting under their direction

(Exemptions:to save a life)

Which schedules have no medicinal use?

Schedule 1

Which schedules are usually POMs?

Schedules 2,3, and 4

Which schedules may be P or POM?

Schedule 5