4. Medicines Regulations and Classification

Question 1

What is the purpose of Medicines Act 1968?

Answer 1

To control the safety, quality and efficacy of medicinal products for human use.

Question 2

What does the Medicines Act 1968 control ?

Answer 2

1. Which medicines can be marketed (licensing)
2. Medicines manufacture, sale and supply
3. Labelling and description
4. Sale promotion

Question 3

What was the Medicines Act 1968 a response to?

Answer 3

Thalidomide

Question 4

What is the purpose of Human Medicine Regulations 2012?

Answer 4

Only covers human medicines (check lecture: Legal and ethics 4)

Question 5

What are the classes of human medicinal products ?

Answer 5

1. General Sales List medicines (GSL)
2. Pharmacy medicines (P)
3. Prescription Only Medicines (POM)

Question 6

Do products classified within GSL require supervision of a pharmacist ?

Answer 6

No, can be sold or supplied with reasonable safety without the supervision of a pharmacist

Question 7

What are the conditions for GSL sale?

Answer 7

1. Must be sold/supplied in a closed place to exclude the public
2. Hold an EU or UK marketing authorisation (or equivalent)
3. Herbal and homeopathic products included
4. Product container made elsewhere and cannot be opened
5. Pharmacy Only (PO) Medicines
6. Excluded certain types of human products (e.g. eye ointments)

Question 8

How would you identify a GSL product ?

Answer 8

1. Has Marketing Authorisation
2. Does not have P or POM

Does not need GSL on box

Question 9

Can a pharmacist be physically absent for a limited period of time when a GSL sale is taking place?

Answer 9

Yes

Question 10

Where and when can a Pharmacy (P) medicine be sold ?

Answer 10

1. Can be sold from a registered pharmacy

2. …by a pharmacist or a person acting under the supervision of a pharmacist

Question 11

Can pharmacy (P) medicines be accessible to the public for self selection ?

Answer 11

NO

Question 12

Can GSL medicines be accessible to the public for self selection ?

Answer 12

Yes

Question 13

What are OTC?

Answer 13

Over the counter medicines including P and GSL

Question 14

How can you identify a P medicine ?

Answer 14

Should have P on the manufactures original packaging

Question 15

What is a POM?

Answer 15

A prescription only medicine which requires a prescription from an appropriate prescriber

Question 16

What is the maximum amount of paracetamol tablets that can be sold to the public, provided that there is a good reason?

Answer 16

Up to 100 but since pack sizes come in 32 and 16 a maximum of 96 can be sold

also applies to aspirin

Question 17

Is there a legal limit to effervescent, liquid, powder, granules paracetamol being sold to a patient ?

Answer 17

No, because it is hard to overdose

also applies to aspirin

Question 18

When is paracetamol considered to be POM and not GSL?

Answer 18

When pack-sizes exceed 32

Question 19

Medicines are POM if…

Answer 19

1. MA as a POM
2. Injections
3. Controlled drugs unless MA specified as P or GSL
4. Non effervescent products containing aspirin, paracetamol or aloxiprin unless MA specified P or GSL
5. Contains ephedrine, its salt or pseudoephadrine, unless MA specifies P or GSL

Look at slide for additional

Question 20

How can you identify a POM ?

Answer 20

States POM on the manufacturers original packaging

Question 21

What are the exceptions from POM

Answer 21

1. Specifically licensed products
2. high dilution products
3. Pack size of certain products
4. Certain controlled drugs at low dose
5. Pseudoephedrine and ephedrine

Question 22

What is the maximum strength allowed for supply of pseudoephedine?

Answer 22

up to 720mg pseudoephedrine salt

Question 23

What is the maximum strength allowed for supply of ephidrine ?

Answer 23

up to 180mg

Question 24

Can you sell a pseudoephadrine product at the same time as an ephadrine product ?

Answer 24

No