PH1122 - medicines laws Flashcards
what does the medical devices regulation 2002 cover `?
covers many non medicinal product items that pharmacists deal with.
What does the misuse of drugs act 1971 & regulations 2001 do ?
controls the supply of medicines likely to be misused (e.g controlled drugs)
What does the medicines (pharmacies) (responsible pharmacist) regulations 2008 cover ?
introduced the role of the responsible pharmacist
What does medicinal products mean ?
In these Regulations “medicinal product” means—
any substance or combination of substances presented as having properties of preventing or treating disease in human beings; or
any substance or combination of substances that may be used by or administered to human beings with a view to—
restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or
making a medical diagnosis.
what are some potential reasons to give an off label medicine and unlicensed medicine ?
If necessary, a product can be used outside the terms of its MA. When the medicine is licensed but its use is not, it is called “off label” use, e.g.
a product licensed for adults might be given to a child
higher (or lower) than licensed dose may be used
a different route of administration might be used (e.g. an injectable liquid might be given orally)
it might be given to treat a different condition
If the patient’s needs still cannot be met, further options are:
import a medicine licensed in its home country (EU preferable to outside Europe)
an unlicensed medicine may be manufactured in the UK
an unlicensed medicine from outside the UK
a non-medicine (e.g. a chemical or a supplement).
It is legal to do all these things but there is an increased responsibility on the prescriber and the pharmacist
what are some general rules for GSL medicine ?
Can be sold with reasonable safety without the supervision of a pharmacist.
Can be sold by retail from a premises which can be closed as to exclude the public
Must have been made up in a container prepared elsewhere & not opened (original packs)
Cannot be sold from a vehicle or market stall (except trains and planes under certain conditions)
Label is not required to have GSL in a box
Certain medicines for human use cannot be classed as GSL -
eye ointments
products with high doses of vitamin A or D
anthelmintics (worming preparations e.g. roundworms, threadworms)
parenteral products (injections)
Enemas (large volume rectal products)
products for use wholly or mainly for irrigating wounds, bladder, vagina, rectum
aspirin for children
What are some general rules for P medicines
Can be 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
What are some general rules for POM medicines.
Only supplied on production of a prescription (usually)
Only supplied from registered pharmacy, by/under the supervision of pharmacist
A medicinal product will be classified as a POM if it
needs medical supervision to reduce possibility of harm or
is widely and frequently misused or
is a new active substance or
is for parenteral administration (to be injected)
Label must contain POM in a box with no other material
What are the different abbreviations for non human medicines ?
Prescription-only Medicine – Veterinarian; abbreviated to POM-V;
Prescription-only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person (SQP); abbreviated to POM-VPS;
Non-Food Animal – Veterinarian, Pharmacist, Suitably Qualified Person; abbreviated to NFA-VPS; and,
Authorised Veterinary Medicine – General Sales List; abbreviated to AVM-GSL.
What is a reason that medicines of the same formulation but different doses may cause it to vary from GSL –> P –> POM
the idea behind it is that the larger the box the longer the time frame before the patient seeks medical help. therefore if the smaller box hasn’t worked they are more likely to ask a health care professional before buying another box.
what is the maximum pack size and maximum amount of paracetamol tablets you can buy as a P medicine
max pack size = 32
max amount of tablets = 100
