MEDICINES FOR GENERAL SALE (GSL) Flashcards

1
Q

What is a GSL medicine? (3)

A
  • 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
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2
Q

Where can you find details of the legal classification of medicines?

A
  • BNF
  • Summary product characteristics
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3
Q

All liquid paraffin BP preparations are GSL. True or false?

A

False - nasal preparations (drops, sprays and inhalations) and oral laxatives are P

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4
Q

What is quinine used for? (4)

A
  • Antipyretic (reduce fever)
  • Leg cramps
  • Chloroquine resistant malaria
  • Analgesic (reduce pain)
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5
Q

When are qunine preparation GSL or P medicines?

A

P - 100mg (maximum dose) OR 300mg (maximum daily dose)

P - 35mg (maximum dose of qunine base)

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6
Q

What legal classification is cetirizine hydrochloride?

A

POM

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7
Q

What legal classification is cetirizine hydrochloride if the maximum daily dose is 10mg?

A

P

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8
Q

What is the max pack size for cetrizine hydrochloride tablets and liquid preparations, sold as GSL?

A
  • 30 tablets (maximum daily dose: 10mg)
  • 70ml (maximum strength = 1mg/ml or 10mg MDD and older than 6)
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9
Q

Beconase Hayfever nasal spray can be sold as GSL. True or false?

A

True

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10
Q

Beconase nasal spray (aqueous) is GSL. True or false?

A

False - it is a POM

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11
Q

Beconase allergy nasal spray is GSL. True or false?

A

False - it is a P medicine

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12
Q

In what places can GSL products be sold in? (3)

A
  1. Retail pharmacies
  2. Other retail shops
  3. Automatic machines
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13
Q

What is the responsibility of the pharmacist in the sale of GSLs? (2)

A
  • Staff training
  • SOPs
  • Responsible pharmacist (RP) must be in charge of premises but doesn’t have to be physically present
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14
Q

What are the conditions for retail stores to sell GSL medicines? (4)

A
  • 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
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15
Q

Which practitioners can give GSL medicines to a patient?

A
  • Doctors
  • Dentists
  • Midwives
  • IF patient under their care
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16
Q

Who can supply GSL medicines under the direction of a prescriber?

A

Hospitals and health centres

17
Q

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?
A
  • 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
18
Q

What is the legal limit of OTC effervescent tablets, powders, granules, or liquids of aspirin/ paracetamol that can be sold at any one time?

A

No legal limit but use professional judgement

19
Q

What are the GSL schedule 15 requirements for aspirin effervescent tablets? (2)

A
  • 0-325mg aspirin per tablet - max 30 tabs
  • more 325mg aspirin BUT up to 500mg - max 20 tabs
20
Q

What are the GSL schedule 15 requirements for EC aspirin tablets?

A
  • Max 75mg per tablet
  • Max 28 tablets
  • Only contain aspirin
21
Q

What is the max pack size for paracetamol/aspirin that is non-effervescent and not enteric coated to be sold GSL?

A

16 tablets

22
Q

What are the GSL schedule 15 requirements for powders/granules and liquid preparations of paracetamol?

A
  • Powders/Granules: Max 10 sachets
  • Liquid preparations (>12years): Max 160ml
  • Liquid preparations (<12 years): Max 100ml, 5ml per dose
23
Q

What are the GSL schedule 15 requirements for tabs/caps, powders/granules and liquid preparations of ibuprofen? (3)

A
  • Capsules/ Tablets - 16
  • Powder/Granules: Max 12 sachets
  • Liquid preparations: Max 100ml, 5ml per dose
24
Q

When can POMs be reclassified to P? (4)

A
  • 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
25
Q

When can P medicines be reclassified to GSL?

A

Wider sale is more convenient and therefore more important than the risk of damage to health or risk of misuse

26
Q

What medicine has been deregulated from a P to a GSL (include forms and its purpose and what group has it be licensed to)?

A
  • Benzoyl Peroxide 5%
  • Face gel (15g) and face wash (50g)
  • For acne with comedones
  • adults that are 12+
27
Q

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)

A
  • 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
28
Q

Can GSLs be prescribed on the NHS?

A

Blacklisted items cannot be prescribed on NHS (e.g. Capol cannot be prescribed by paracetamol can) - NHS will not reimburse

29
Q

If a GSL was prescribed on the NHS or by private prescriber, what are the legal prescription requirements for GSL medicines?

A
  • 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
30
Q

Is PO medicines a legal classification in HMR 2012?

A

No, a PO medicine is licensed as a GSL medicine but can only be sold in a pharmacy

31
Q

What are the conditions for selling PO medicines? (3)

A
  • RP must be signed on
  • Sale doesn’t need to be supervised by a pharmacist
  • PO medicines are available by self selection