P & GSL Flashcards
What are the legal classes of UK products? (3)
General Sales List (GSL)
Pharmacy (P)
Prescription-Only Medicines (POM)
How would you find the legal classification of a medicine? (4)
BNF
Packaging
SPC
PAGB OTC directory
What is the usual move of medicine classes? (1)
POM -> P -> GSL
What is the rare move of medicine classes? (1)
GSL -> P -> POM
What are the potential restrictions with medicines? (4)
Indication
Pack Size
Strength
Route of Administration
What are the benefits of switching medicines classes? (3)
Widens patients access to medicines
Greater use of pharmacists’ expertise
Gov. Keen to declassify medicines - ‘self-care’ agenda, removes NHS cost.
Give e.g. of recent POM to P medicines. (3)
Desogestrel
Topical vaginal oestrogen
Tadalafil
What does HMR 2012 state about general medicinal sales? (1)
GSL don’t need to be sold from a registered pharmacy under the supervision of the pharmacist.
Define GSL. (2)
Not a P or POM
Has an MA that the product is available for general sale.
What conditions should be fulfilled for a retail sale of GSL medicines? (3)
Premises can be closed so as to exclude the public e.g. vending machines.
Product must have been made up for sale in a container elsewhere and not have been opened since then.
If sold from a pharmacy, a RP must have signed in and assumed this role.
Sale of GSL medicines can be in an aircraft (commander) / Train (operator)
What are the changes to the legal status of OTC stimulant laxatives? (7)
Stimulant laxatives susceptible to misuse. E.g. senna/sennoside, bisacodyl, sodium picosulfate.
Pack size restrictions (Small (GSL) for tx of constipation for short term use. Limited to pack size of 2 short tx courses i.e. up to 20 standard-strength tablets, 10 max strength tablets or 100ml solution/syrup. Large (P) up to 100 tablets.
GSL products only licensed for >=18 yrs.
Stimulant laxatives not for children < 12 yrs without advice from a prescriber while products for children 12-17 years can be supplied under supervision of a pharmacist (P).
Warnings on PIL:
- Overuse of laxatives = harmful due to risk of fluid/electrolyte disturbances and intestinal function disruption.
- Doesn’t aid weight loss.
Define P medicines. (2)
Medicine not POM/GSL or which are classified by manufacturer as P in their MA.
Medicines made in pharmacy.
Give e.g. of P medicines for strength/form. (1)
Hydrocortisone 1% cream
Give e.g. of P medicines for a specific indication. (1)
Naproxen 250mg primary dysmenorrhea for 15-50 yrs.
Give e.g. of CDs given at a low strength. (3)
Codeine
Dihydrocodeine
Morphine
What are the main features of Schedule 15 products? (4)
Paracetamol, Aspirin, Ibuprofen
Paracetamol 500mg (non-soluble):
- Pack size 16 (GSL)
- Pack size 32 (P)
- Illegal to sell a quantity of > 100 tablets OTC as it’s classified as POM.
Paracetamol tablets (soluble) no legal max.
What are the main features of retail sale of P medicines? (4)
May not be sold by any person unless:
- They’re lawfully conducting a pharmacy business.
- Registered pharmacy
- They’re a pharmacist or acting under the supervision of a pharmacist.
- N/A in event of pandemics.
What is the legal definition of supervision? (1)
The pharmacist must be aware of the sale and be in a position to intervene where necessary.
Explain the sales of P medicines whilst the pharmacist is in the consultation room.
Pharmacy has to have a robust SOP in place.
Ensure staff follows these procedures.
Pharmacist is happy for sales to take place.
What are the 3 main options for P medicine locations in a pharmacy? (3)
P medicines stored behind the pharmacy counter. Shouldn’t be placed on self-selection shelves unless empty boxes are placed instead then requested at the counter for the actual product.
P medicines in front of the medicine counter but behind glass or plastic lockable doors.
Not for open displays.
State the main features of ephedrine/pseudoephedrine. (7)
Decongestants (P)
Potential for misuse/abuse
Legal maximum quantity:
- 720mg pseudoephedrine,
- 180mg ephedrine.
Unlawful to sell a pseudoephedrine containing product with ephedrine product.
Sale must be made by a pharmacist or by trained member of staff who knows when it’s necessary to refer to the pharmacist.
Suspicions reported to local GPhC inspector, local CD liaison police officer or accountable officer.
State the main features of codeine/dihydrocodeine. (6)
Low strengths (P medicines)
Risk of abuse/misuse with LT use.
Indication: acute/moderate pain not relieved by Schedule 15 products. Not recommended for cold, flu, cough, sore throats and minor pain.
Pack size: Max pack size 32 dose units (all forms including effervescent. > 32 = POM)
PIL/Labels:
- ‘Can cause addiction for 3 days use only’
- Can cause addiction or overuse headaches for used continuously for > 3 days.
Only 1 pack sold to be sold per transaction.
What are the main features of promoting medicines? (5)
‘Free gifts’ of medicines = illegal.
Aims to sell higher quantities of medicines that px needs are unprofessional and can compromise px safety.
Price promotions may encourage stock piling of medicines by px and subsequent use for too long a duration or use beyond expiry date.
Most medicines for OTC are for short-term relief of acute condition. Continual use should be questioned.
Key issue: public safety and encouraging appropriate use of medicine.
Give e.g. of products that aren’t GSL. (6)
Products containing > specified max daily dose of vitamin A/D.
Eye ointment
Anthelmintics*
Parenteral administration*
Enema*
Wholly or mainly for irrigation of wounds or of bladder, vagina/rectum.*
For administration wholly or mainly to children being a preparation of Aloxiprin/Aspirin.*
Unless MA = GSL*
