B1. Intro to classification of meds

Question 1

what is a licence required for?

Answer 1

the sale, supply and administration of medicines and medical devices for human use

Question 2

what is the licensing body?

Answer 2

the medicines and healthcare products regulatory agency (MHRA)

Question 3

Describe marketing authorisation (MA)

Answer 3

-name given to the licence with full regulatory approval
-places restrictions on products

Question 4

what is the classification of medicines controlled by?

Answer 4

human medicines regulations 2012: sale or supply of medicinal products

Question 4

What are the different classes of medicine products?

Answer 4

-general sale list medicines (GSL)
-Pharmacy medicines (P)
-Prescription only medicines (POM)

Question 5

Describe GSL medicinal products

Answer 5

-can be sold or supplied with reasonable safety without the supervision of a pharmacist
-includes some herbal and homeopathic products
-excludes certain types of products e.g eye ointments, injections

Question 6

what are the conditions for GSL sale medicines?

Answer 6

-Place where sold or supplied must be able to close so as to exclude the public (proper shop)
-has a UK marketing authorisation (or equivalent for herbal and homeopathic)
-must have been made up in a container elsewhere and not altered

Question 7

how do you identify a GSL medicine?

Answer 7

GSL medicine does not need anything on the box to identify it. Therefore product is GSL if it has a marketing authorisation (MA) and is not a P or POM medicine

Question 8

Pharmacy (P) medicines definition?

Answer 8

neither a Prescription Only Medicine (POM) or GSL medicine

Question 9

what are the restrictions on the sale and supply of Pharmacy (P) medicines?

Answer 9

may not be sold, supplied or offered for sale/supply unless:
1)person is lawfully conducting a retail pharmacy business
2)the product is sold, offered or exposed for sale, or supplied on premises which are a registered pharmacy
3)the person is, or acts under the supervision of a pharmacist
-products must not be accessible for self selection

Question 10

how do you identify a Pharmacy medicine?

Answer 10

must have a P in a box somewhere on the original packaging

Question 11

what are over the counter (OTC) medicines?

Answer 11

GSL+P medicines (non-prescription)

Question 12

what laws and regulations control OTC medicines as a group?

Answer 12

-MA specifies legal category
-Regulations impose restrictive conditions e.g pack sizes

Question 13

what is the maximum pack size for aspirin and paracetamol (non-effervescent) tablets or capsules in GSL and P medicines?

Answer 13

16 (GSL) and 32 (P)
-maximum quantity = 100 (96 in reality)

Question 14

what are the conditions for prescription only medicines (POMs)?

Answer 14

A pharmacist may sell or supply a POM under the authority of a prescription from an appropriate practitioner, or via an exemption (patient specific directions, PSDs)

Question 15

POM medicines are listed in the Prescription Only Medicines Order and/ or…

Answer 15

1. Hold a marketing authorisation (MA) as a POM
2. For parenteral administration
3. Emit radiation on administration
4. Cyanogenic (if not for external use)
5. Controlled drugs, unless MA specifies P or GSL
6. Non-effervescent products containing aloxiprin, aspirin or paracetamol, unless
   MA specifies P or GSL
7. Contain ephedrine, its salts or pseudoephedrine, unless MA specifies P or GSL
8. Products without a MA meeting certain criteria

Question 16

How to identify a POM medicine?

Answer 16

letters POM on the original packaging

Question 17

What products are exempt from POM status?

Answer 17

specifically licensed products sold within the terms of that licence e.g Hana (desogestrel) oral contraceptive

Question 18

Up to how much pseudoephedrine salts and ephedrine base/ salts can you sell or supply to one person in a single transaction?

Answer 18

-up to 720mg pseudoephedrine salts
-up to 180mg ephedrine base/ salts
-you may not supply more than one product containing the same drug and may not supply both drugs, even within limits

Question 19

who can administer POMs?

Answer 19

no one can administer parenterally (by injection), other than to themselves, unless they are a practitioner or acting under the direction of a practitioner
(exemptions during emergency)

Question 20

Describe the controlled by misuse of drugs act 1971/ Regulations 2001

Answer 20

-concerns drugs which are likely to be misused
-restricts production, obtaining, supply, offer to supply, possession and cultivation of controlled drugs
-schedules determine the control of the drugs (one note)