Legal classification and prescription requirements
Call Kai
Learn
Practice Test
Spaced Repetition
Match
Flashcards
Knowt Play1/73
There's no tags or description
Looks like no tags are added yet.
74 Terms
What are the three legal classes of medicines?
POM, P and GSL.
What does POM sand for?
Prescription Only Medicine.
What does P stand for?
Pharmacy Medicine.
What does GSL stand for?
General Sales List Medicine.
How are POM medicines normally supplied?
Against a valid prescription from an appropriate practitioner unless a legal exemption applies.
How may P medicines be sold or supplied?
Without a prescription from a registered pharmacy under pharmacist supervision.
How may GSL medicines be sold?
Without pharmacist supervision if GSL conditions are met.
Give examples of POM medicines.
Antibiotics, antihypertensives, antidepressants, insulin and most injections.
Give examples of P medicines.
Larger OTC analgesic packs, chloramphenicol eye drops meeting product conditions and emergency hormonal contraception.
Give examples of GSL medicines.
Small packs of paracetamol or aspirin, some ibuprofen products and some cough and cold remedies.
Is there a fourth legal class called 'pharmacy only'?
No, the only legal classes are POM, P and GSL.
Where are POM medicines normally sold or supplied from?
A registered pharmacy or other lawful supply setting, usually against a valid prescription or legal exemption.
Where must P medicines be sold or supplied from?
A registered pharmacy.
What supervision is required for the sale of P medicines?
Sale or supply must be by or under the supervision of a pharmacist.
Where can GSL medicines be sold?
From premises that can be closed to exclude the public.
What condition applies to GSL medicines sold by general sale?
They must be sold in the manufacturer's original unopened pack.
What medicines may be sold from a vending machine?
Only GSL medicines.
Can P or POM medicines be sold from a vending machine?
No.
What factors can affect whether a medicine is classified as POM, P or GSL?
Strength, formulation, route, indication, patient group, dose, treatment duration, pack size, quantity supplied and product-specific warnings.
Why should you classify the product rather than the ingredient?
The same active ingredient can have different legal classifications depending on product conditions.
When can chloramphenicol 0.5% eye drops be supplied as a P medicine?
When authorised product conditions are met for acute bacterial conjunctivitis.
What age group can receive chloramphenicol 0.5% eye drops as a P medicine?
Adults and children over 2 years.
What is the difference between pack size and sales quantity?
Pack size is the number of tablets in one pack, while sales quantity is the total number sold to a person at one time.
What is the maximum GSL pack size for non-effervescent paracetamol or aspirin tablets/capsules?
16 tablets or capsules.
What is the maximum pharmacy pack size for non-effervescent paracetamol or aspirin tablets/capsules?
32 tablets or capsules.
What is the legal maximum quantity of non-effervescent paracetamol or aspirin that can be sold at one time?
100 tablets or capsules.
What is the practical intact-pack maximum quantity of non-effervescent paracetamol or aspirin?
96 tablets or capsules.
Why is the practical intact-pack maximum 96 tablets?
Because it equals 6 packs of 16 or 3 packs of 32.
What is MHRA best-practice guidance for paracetamol and aspirin sales?
A maximum of 2 packs per transaction.
Is the MHRA 2-pack limit a legal requirement?
No, it is best-practice guidance.
How many tablets are in 2 GSL packs of paracetamol?
32 tablets.
Is the sale of 96 paracetamol tablets within the legal limit?
Yes, because it is below 100 tablets.
Does selling 96 paracetamol tablets follow MHRA best practice?
No, because it exceeds the recommended 2-pack limit.
Is selling 112 paracetamol tablets legal?
No, because it exceeds the legal maximum of 100 tablets.
What is the low-dose aspirin GSL exception?
Enteric-coated aspirin 75 mg or less may be supplied in GSL packs of up to 28 tablets.
What numbers should be memorised for paracetamol and aspirin OTC sales?
16, 32, 100, 96 and 2 packs.
What is POM to P reclassification?
The process of changing a medicine from Prescription Only to Pharmacy medicine under defined conditions.
Who applies for a POM to P reclassification?
The marketing authorisation holder.
Who assesses whether a product can be reclassified from POM to P?
The MHRA.
Does POM to P reclassification mean a medicine is risk-free?
No.
Can the same active ingredient exist as both POM and P products?
Yes.
What factors may be restricted after POM to P reclassification?
Indication, strength, dose, duration, age, counselling requirements and pack size.
Give examples of medicines that have undergone POM to P reclassification.
Ibuprofen, hydrocortisone 1% cream, chloramphenicol eye drops, levonorgestrel and sildenafil.
What legislation covers manufacturer labelling requirements?
HMR 2012 Regulation 257 and Schedule 24.
Does manufacturer labelling refer to the dispensing label?
No, it refers to the manufacturer or marketing-authorisation packaging.
What information must appear on manufacturer labelling?
Medicine name, strength, pharmaceutical form, active substances, pack contents, route of administration, warnings, expiry date, storage conditions, MA holder, MA number and batch number.
What legislation covers Patient Information Leaflet requirements?
HMR 2012 Regulation 260 and Schedule 27.
What is a PIL?
A Patient Information Leaflet supplied with a medicine.
What document must a PIL be based on?
The Summary of Product Characteristics (SmPC).
How must information be presented in a PIL?
In the Schedule 27 order and in a clear, legible format.
When must a PIL be included in a medicine pack?
Unless all required information already appears on the packaging.
Can you substitute a leaflet from a different manufacturer?
No.
Is supplying a required PIL optional good practice?
No, it is a legal requirement.
What risk is created when dispensing split packs?
The patient may not receive the correct current PIL.
What resource can be used to check current SmPC and PIL information?
The Electronic Medicines Compendium (eMC).
What regulation contains the core legal requirements for ordinary prescriptions?
HMR 2012 Regulation 217.
What must a prescription be written in?
Ink or another indelible format.
Who must sign a prescription?
The appropriate practitioner.
What date information is required on a prescription?
The date of issue.
What practitioner information is required on a prescription?
The practitioner's address.
What repeatability information is required on a prescription?
Whether the prescription is repeatable.
What patient details are required on a prescription?
Patient name and address.
When must a patient's age be included on a prescription?
When the patient is under 12 years old.
How long is an ordinary POM prescription normally valid for?
6 months from the appropriate date.
Is a patient title legally required on a prescription?
No.
Is a patient postcode legally required on a prescription?
No.
Is the practitioner's printed name legally required in addition to their signature?
No.
Are dose, strength, form and quantity legally required under Regulation 217?
No, although sufficient information must exist for safe supply.
What are the core requirements for a private prescription?
Patient name, patient address, age if under 12, practitioner signature, practitioner details/address, date, repeatability status and indelible format.
What are the core legal requirements shared by NHS and private prescriptions?
The Regulation 217 requirements.
What additional requirements apply to NHS prescriptions?
NHS form, EPS and processing requirements.
Why do NHS prescriptions often include strength, form and quantity?
To satisfy NHS processing and payment requirements.
Can private prescriptions be repeatable?
Yes, if indicated by the prescriber.
Are NHS prescriptions usually intended for one supply?
Yes, unless supplied through an NHS repeat dispensing or service route.