MEDICINES FOR GENERAL SALE (GSL) Flashcards
What is a GSL medicine? (3)
- Product that’s not a POM or P medicine
- A product that’s covered by a marketing authorisation that states product is available on general sale
- Doesn’t need to be supervised by a pharmacist
Where can you find details of the legal classification of medicines?
- BNF
- Summary product characteristics
All liquid paraffin BP preparations are GSL. True or false?
False - nasal preparations (drops, sprays and inhalations) and oral laxatives are P
What is quinine used for? (4)
- Antipyretic (reduce fever)
- Leg cramps
- Chloroquine resistant malaria
- Analgesic (reduce pain)
When are qunine preparation GSL or P medicines?
P - 100mg (maximum dose) OR 300mg (maximum daily dose)
P - 35mg (maximum dose of qunine base)
What legal classification is cetirizine hydrochloride?
POM
What legal classification is cetirizine hydrochloride if the maximum daily dose is 10mg?
P
What is the max pack size for cetrizine hydrochloride tablets and liquid preparations, sold as GSL?
- 30 tablets (maximum daily dose: 10mg)
- 70ml (maximum strength = 1mg/ml or 10mg MDD and older than 6)
Beconase Hayfever nasal spray can be sold as GSL. True or false?
True
Beconase nasal spray (aqueous) is GSL. True or false?
False - it is a POM
Beconase allergy nasal spray is GSL. True or false?
False - it is a P medicine
In what places can GSL products be sold in? (3)
- Retail pharmacies
- Other retail shops
- Automatic machines
What is the responsibility of the pharmacist in the sale of GSLs? (2)
- Staff training
- SOPs
- Responsible pharmacist (RP) must be in charge of premises but doesn’t have to be physically present
What are the conditions for retail stores to sell GSL medicines? (4)
- Must be able to lock premises to exclude public
- Medicines must be assembled elsewhere
- Packaging must not be opened
- Schedule 15 requirements must be met
Which practitioners can give GSL medicines to a patient?
- Doctors
- Dentists
- Midwives
- IF patient under their care
Who can supply GSL medicines under the direction of a prescriber?
Hospitals and health centres
What is the number of paracetamol and asprin (non-effervescent) tablets/capsules for it:
- a) to be a GSL medicine
- b) to be a P medicine?
- Tablets/ capsules have to be up to 500mg
- GSL - 16 tablets/ capsules
- P - 17-32 tablets/ capsule
- But no more than 100 sold at a time
What is the legal limit of OTC effervescent tablets, powders, granules, or liquids of aspirin/ paracetamol that can be sold at any one time?
No legal limit but use professional judgement
What are the GSL schedule 15 requirements for aspirin effervescent tablets? (2)
- 0-325mg aspirin per tablet - max 30 tabs
- more 325mg aspirin BUT up to 500mg - max 20 tabs
What are the GSL schedule 15 requirements for EC aspirin tablets?
- Max 75mg per tablet
- Max 28 tablets
- Only contain aspirin
What is the max pack size for paracetamol/aspirin that is non-effervescent and not enteric coated to be sold GSL?
16 tablets
What are the GSL schedule 15 requirements for powders/granules and liquid preparations of paracetamol?
- Powders/Granules: Max 10 sachets
- Liquid preparations (>12years): Max 160ml
- Liquid preparations (<12 years): Max 100ml, 5ml per dose
What are the GSL schedule 15 requirements for tabs/caps, powders/granules and liquid preparations of ibuprofen? (3)
- Capsules/ Tablets - 16
- Powder/Granules: Max 12 sachets
- Liquid preparations: Max 100ml, 5ml per dose
When can POMs be reclassified to P? (4)
- POMs can never go straight to GSL
- Will not present a danger to health if used without supervision
- Not commonly misused
- Does not contain substance requiring further investigation (activity and side effects need to be investigated)
- Not normally administered by injection
When can P medicines be reclassified to GSL?
Wider sale is more convenient and therefore more important than the risk of damage to health or risk of misuse
What medicine has been deregulated from a P to a GSL (include forms and its purpose and what group has it be licensed to)?
- Benzoyl Peroxide 5%
- Face gel (15g) and face wash (50g)
- For acne with comedones
- adults that are 12+
What medicines have been reclassified from a P to a POM medicine? (include forms and its purpose and what group has it be licensed to)? (2)
- Oral diclofenac (caused a small increased risk of arterial thromboembolic events)
- Domperidone (motilium 10mg tab/ orodispersible tabs) - contraindicated in underlying cardiac disease + severe hepatic impairment
Can GSLs be prescribed on the NHS?
Blacklisted items cannot be prescribed on NHS (e.g. Capol cannot be prescribed by paracetamol can) - NHS will not reimburse
If a GSL was prescribed on the NHS or by private prescriber, what are the legal prescription requirements for GSL medicines?
- All prescriptions legally still need legal or clinical check
- No legal prescription requirements under HMR 2012 for GSLs but NHS prescriptions must be written in accordance with NHS regulations to get reimbursed
- Private prescriptions don’t need to be signed or dated
Is PO medicines a legal classification in HMR 2012?
No, a PO medicine is licensed as a GSL medicine but can only be sold in a pharmacy
What are the conditions for selling PO medicines? (3)
- RP must be signed on
- Sale doesn’t need to be supervised by a pharmacist
- PO medicines are available by self selection
