Medicines Law Flashcards
Human Medicines Regulations 2012
Brought together simplified medicines legislations
Medical Devices Regulations 2002
Covers **non-medicinal product items that pharmacists deal with
Misuse of Drugs Act 1971 and Regulations 2001
Controls supply of medicines likely to be misused
Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008
Introduced the role of the Responsible Pharmacist
Medicinal Products Regulation
Any substance or combination of substances presented as having properties of preventing or treating disease in human beings or restore or make a medical diagnosis
What authorisations are medicines supposed to get before they are sold/supplied?
Marketing Authorisations (MA). Medicines which meet standard of safety, quality and efficacy are granted a Marketing Authorisation
What does MHRA stand for?
Medicines and Healthcare Products Regulatory Agency
Off-label medicines
A product that can be used outside the terms of its MA e.g product licensed adults given to a children, treat a different condition ect.
Unlicensed medicines
If patients needs still not met, further options are:
- Import a medicine licensed in home country
- Unlicensed UK medicine
- Unlicensed abroad medicine
- Non-medicine (chemical or supplement)
The three classifications of medicinal products
- General Sales List (GSL)
- Pharmacy (P)
- Prescription Only Medicines (POM)
General Sales List medicines rules
- Can be sold without supervision of a pharmacist
- Can be sold by retail
- Must be in the original packs and unopened
- Cannot be sold from a vehicle or market stall (except trains and planes under certain conditions)
- Label not required to have GSL
- Can sell maximum 16 paracetamol
Pharmacy Medicines
- Supplied from a registered pharmacy by or under the supervision of a pharmacist
- Label must contain ‘P’ in a box with no other material
- Must not be accessible to the public for self-selection
Prescription Only Medicines (POM)
- Only supplied on production of prescription (usually)
- Only supplied from registered pharmacy, by/under pharmacist supervision
- Label must contain POM in a box with no other material
When is a medicinal product considered a POM?
- Needs medical supervision to reduce possibility of harm
- Widely and frequently misused
- A new active substance
- For parenteral administration
Paracetamol (500mg) or aspirin (<325) tablets and capsules pack size
GSL = 16
P = 32
POM = n/a
Paracetamol (500mg) or aspirin (<325) tablets and capsules maximum no. tabs
GSL = 100
P = 100
POM= n/a
Paracetamol or aspirin pack size and tab exception
- Aspirin e/c 75mg tablets pack size up to 28 GSL, max 100
- Doesn’t apply to granules, powders, effervescent tablets, liquids
Ibuprofen tablets and capsules quantity/pack size
MHRA only permit a max of 16 tablets/capsules (200mg only) to be sold GSL, 32 P
Pseudoephedrine and ephedrine capsules quantity/pack size
- POM= a prescription is required to supply more than 720 mg of pseudoephedrine or more than 180mg ephedrine TOTAL in pack
- P= less than 720mg or 180mg
- Cannot be sold together
Codeine and dihydrocodeine quantity/pack size
P= Max pack size 32 (including effervescent).
Not available as GSL
What factors can affect the classification of a drug?
- Formulation
- Strength
- Indication (the type of condition its being used for)
- Marketing Authorisation
What does a CE mark indicate
Indicates it is a device and not a medicine
Why may a medicines category/classification change?
- To make it more/less restricted
- A change in category is often associated with limitations on pack size/dose/indication
What are herbal products marked with?
A THR number (Traditional Herbal Registration). They must comply with law but doesn’t have an MA so cannot make claims about efficacy
What are homoeopathic products?
- Made from natural substance and are highly diluted to produce remedies (the more diluted the more effective)
- Contains no active ingredient and the royal pharmaceutical society does not endorse it as a form of treatment because there is no evidence to support its efficacy
What are the responsibilities of a Responsible Pharmacist?
- Check procedures are in place that support the safe + effective running of the pharmacy
- Complete the pharmacist record to show who the RP is at any given time
- Display a notice with name + registration number stating they are in charge
- There can only be RP for a pharmacy at any given time
- A pharmacist can only be responsible for one pharmacy at a time
- Remains responsible for activities undertaken when he/she is absent
What can run when the RP is absent and there is no other pharmacist present?
- Sell GSL medicine
- Take in prescriptions
- Get prescriptions ready
What can run when the RP is absent and there is another pharmacist present?
- Sell GSL, P medicine
- Take in prescriptions
- Get prescriptions ready
- Give out prescriptions
In what conditions is the pharmacy allowed to run when the RP is not physically on the premises?
- RP remains contactable
- Adequate standard operating procedures are in place so pharmacy runs effectively and safely
- RP is able to return (can be absent for max 2 hrs in 24 hrs period)
What is required for the pharmacy record?
- Must be kept for 5 years after last entry if paper or indefinitely if electronic
- Date, full name, Gphc number, sign in/sign out time, time of leaving/returnin
- Total time absent and reason for absence
