Flashcards in POMs, GSLs, Ps And POs Deck (77)
What does GSL stand for?
General Sale List
What does P stand for?
What does PO stand for?
Pharmacy only medicine
What is a GSL?
A medicinal product that is not a prescription only medicine or a pharmacy medicine (P) but has an authorisation which states that it is to be available on general sale
This authorisation may be:
UK marketing authorisation/ THR/ article 126a
These are MPs that with reasonable safety, can be sold or supplied without supervision of the pharmacist, they are obtainable from any lockable premises eg. A supermarket
Examples of things that aren't usually GSLs?
Aspirin containing products for children
Vitamin A and D containing products over a certain amount
paracetamol/aspirin if sold over certain pack sizes get classified as P
Limits get imposed on the pack sizes of certain GSL products when they're sold from non pharmacy businesses (eg supermarkets) eg?
Aspirin 75mg- 28 tablets
Ibuprofen- 16 tablets
What is a PO?
A substance which contains GSL ingredients but is licensed for sale through pharmacies only.
Cystemme cystitis sachets
Note: PO is not an official class of medicinal product under the HMR (Human medicines regulations)
What is a P medicine?
A product that is not a POM product or a medicinal product subject to general sale but it covered by an authorisation which states it should only be available from a pharmacy
These MPs require more control than GSLs
Larger quantities, higher concs and higher doses of GSLs
Mix of two GSLs= P
Made up in pharmacy and it's ingredients aren't POM
They're obtainable only from registered pharmacies with a responsible pharmacist present
Where / by who can P medicines be supplied?
A person lawfully running a retail pharmacy
From premises that are a registered pharmacy
Acts under supervision of a pharmacist
What are retail sales?
Any sales that don't fall into the meaning of wholesale dealing
What does supervision mean?
The pharmacist must be aware of what is going on and must be in a position to intervene in a transaction
What 7 types of MPs are POM?
MPs with a marketing authorisation which classifies it as a POM
MPs that are controlled Drugs
MPs for parenteral administration.
Aloxiprin, aspirin and paracetamol products
Pesuedoephedrine and ephedrine products
A person may not parenterally administer (unless to himself) a POM unless the person is?
An appropriate practitioner
Acting in accordance with the direction of such an appropriate practitioner
Who are classed as appropriate prescribers of medicines for human use?
Doctor, dentist, nurse independent prescriber, supplementary prescriber, pharmacist IP, optometrist IP, community practitioner nurse prescriber (but only certain POMs)
Ephedrine and pseudoephidrine are exemptions from POM classification under certain circumstances.
Although it is unlawful to supply the following without a Rx:
Product containing more than 720 mg pseudoephidrine or 180 mg ephedrine
A product containing ephedrine with a product containing pseudoephidrine together in one transaction.
All controlled drugs are POMs but __ CDs may be P medicines under certain conditions....
How long are new medicinal products a POM for after first
Iicensing unless there is existing evidence of safety?
For 5 years after first licensing
When can a MP switch from POM to P?
When MP is safe to be supplied without a prescription and not likely to be dangerous without prescriber supervision, or normally prescribed for parenteral admin. usually takes around 5 years
P-> POM if new risks are identified which need a prescriber to be involved eg a bad drug interaction.
Example: terfendinine (antihistamine)
When can an MP switch from P to GSL?
When an MP is safe to be supplied without the supervision of a pharmacist....
GSL-> P when MP is not longer safe to be supplied without supervision of a pharmacist
What are codeine and dihydrocodeine indications?
Short term treatment of acute moderate pain that is not relived by paracetamol, aspirin or ibuprofen alone
What is the maximum pack size of codeine and dihydrocodeine?
Max 32 doses
What labels and PIL info need to be present with codeine and dihydrocodeine?
"can cause addiction. For 3 day use only"
Can cause headache if use for over 3 days
PIL should give info on warning signs of addiction
Indication must be stated
Medicines containing antitussives, expectorants, nasal decongestants and antihistamines should NOT be used for _____
Cough and cold medicines usually contain these
what's the legal class of:
OSodium Chloride BP
OSalt (Sodium Chloride) Tablets BP
OSodium Chloride Mouthwash BP (made up in the Pharmacy)
OSodium Chloride Injection
OCommon Salt. NOT a MP. (just salt-food!)
OSodium Chloride BP= GSL
OSalt (Sodium Chloride) Tablets BP= GSL
OSodium Chloride Mouthwash BP (made up in the Pharmacy)= P
OSodium Chloride Injection= POM (parenteral!)
What is the legal class of:
OIbuprofen Tablets 400mg for headache
OInjection of Hydrocortisone 100mg/ml
OParacetamol Tablets 500mg 16
OChloramphenicol 0.5% Eye Drops 10ml
OWater for injection 10ml
OIbuprofen Tablets 400mg for headache = P
OInjection of Hydrocortisone 100mg/ml = POM
OParacetamol Tablets 500mg 16 = GSL
OChloramphenicol 0.5% Eye Drops 10ml = POM or P
OWater for injection 10ml = POM
What is a POM?
They're obtainable by wholesale dealing, they can only be supplied when a prescription is present.
Eg a practitioner may obtain a POM by wholesale from a pharmacy or wholesaler
What 4 ways is a member of the public able to obtain a POM?
Against a valid prescription from a practitioner
Emergency supply at request of doctor/ patient
By a Patient Group Direction
Who are Private POM prescriptions funded by?
So you don't send it to NHS BSA
Are repeat prescriptions allowed on private prescriptions?