From POM to P From POM to P

Wellard’s NHS trainingwellards.co.uk

2004

POMs and Ps: POMs and Ps: legal status of medicineslegal status of medicines

The Medicines Act 1968 controls the supply and sale of medicines

• Legal status of a medicine is part of marketing authorisation 1 (MA). Available as:

– POM: Prescription only medicine

– P: Available in pharmacy without prescription under supervision of pharmacist

– GSL: General sales list

1. Since April 2002

BackgroundBackground

The NHS Plan:

‘To introduce a wider range of over the counter medicines and both simplify and speed switches whilst continuing to protect public health.’ 2

2. The NHS Plan: a plan for investment, a plan for reform (2000)

Government policyGovernment policy

‘The promotion of self-care, enabling more of us to take care of ourselves at home.’ 3

3. December 2000

Switching from POM to PSwitching from POM to P

POM to P can occur when a medicine is deemed safe to be supplied without a prescription, ie, when a medicine no longer:

a) is likely to present a direct or indirect danger to human health, even when used incorrectly, if used without the supervision of a doctor

b) is frequently and to a wide extent used incorrectly, and as a result is likely to present a direct or indirect danger to human health

c) contains substances or preparations of substances of which the activity requires, or the side effects require, further investigation

d) is normally prescribed by a doctor for parenteral administration (ie, by injection) 4

4. Medicines Act 1968, section 58A

Reclassification requirementsReclassification requirements

• Generally initiated by company with marketing authorisation 5

• For POM to P, Medicines and Healthcare Products Regulatory Agency (MHRA) considers:

– Clinical expert report: demonstrating that none of POM criteria apply

– Drug used for some years

– Adverse reactions few and minor

– Sufficient evidence of safety

– Patient information – full details of leaflets, labels and indication of advertising plans

– Training and education – summary of education/training provision5. Can also be made by any interested party ie, MHRA

Reclassification: Reclassification: processprocess

• Applications evaluated by MHRA with advice from Committee on Safety of Medicines (CSM)

• Public consultation

• Reclassification only applies to the product that has gone through process. All other products with same active substance need to make a separate application

• UK procedures are basis for new EU procedures

The story so farThe story so far

• Some 50 substances reclassified

• Important changes including:

– Nicotine replacement therapy (NRT)

– Emergency contraception

– Hay fever treatments

– Pain killers

– And now…

Stop press: Stop press: ZocorZocor

• Next POM to P?

• Reclassification from POM to P of Zocor Heart-Pro (10mg)

– 17/11/03 consultation document

– Go-ahead for the move granted in May 2004 for implementation later in the summer

ChangesChanges

• No longer possible to have more than one legal supply status on a single marketing authorisation. Therefore POM, P and GSL versions of the same product require different brand names

• Legal status becomes part of the marketing authorisation (MA) rather than determined by the active substance listed in secondary legislation