Medicines and the law/prescription writing and signed orders Flashcards
when was the medicines act published
1968
what does the medicines act 1968 define
three legal categories of medicine
what are the three legal categories of medicine that the medicines act 1968 defines
- general sales list medicines (GSL)
- pharmacy medicines (P)
- prescription only medicines (POM)
what 2 things does the medicines act 1968 define about the general sales list GSL
- GSL medicines can be sold by a wide range of shops, such as news agents and supermarkets
- often only a small pack size or low strength of the medicine may be sold
what does the medicines act 1968 state about the pack size of general sales list medicines of paracetamol in shops
the largest pack size of paracetamol that shops can sell is 16 tablets
what does the medicines act 1968 state about the pack size of general sales list medicines of paracetamol in pharmacies
the largest pack size of paracetamol that pharmacies can sell is 32 tablets
what does the medicines act 1968 state about the strength of general sales list medicines of ibuprofen in shops
the highest strength of ibuprofen tablets that shops can sell is 200mg
what does the medicines act 1968 state about the strength of general sales list medicines of ibuprofen in pharmacies
the highest strength of ibuprofen tablets that shops can sell is 400mg
what 2 things does the medicines act 1968 state about pharmacy medicines P
- pharmacy medicines can only be sold from pharmacies and a pharmacist must make or supervise the sale (so pharmacists can intervene if necessary)
- pharmacists may ask patients if they have any medical conditions or take any other medications, to check that it is safe to take the medicine
as part of the medicines act 1968 on pharmacy medicines P, what may a pharmacist ask patients and why
if they have any medical conditions or take any other medications
to check that it is safe to take the medicine
who were the only 2 groups or people allowed to prescribe when the medicines act 1968 was published?
and who else is also now allowed to legally prescribe since then?
- doctors and dentists
- now several professions can legally prescribe supplementary or independent prescribers including: nurses, pharmacists, pediatrists, physiotherapists etc
what does the medicines act 1968 state about prescription only medicines
prescription only medicines cannot be without a prescription from an appropriate prescriber
what are some prescription only medicines classed as, and name 3 examples
classed as controlled drugs such as:
morphine, pethidine and methadone
what applies to class controlled prescription only medicines
stricter legal controls
when did the human medicines regulations come into force and what did it replace
on 14th august 2012 - medicines for human use in the UK
this replaced the medicines act 1968 and subsequent medicines legislation
what was the human medicines regulations 2012 the result of
the initiative by the medicines and healthcare products regulatory agency (MHRA) to consolidate and view UK medicines legislation
what 2 things does the human medicines regulations 2012 replace
- most of the medicines act 1968
- around 200 statutory instruments in the process
what exemptions is now defined within the human medicines regulations 2012
exemptions from the general rules laid down in he medicines act for optometrists
what is the 2 exemptions that are now defined within the human medicines regulations 2012 for optometrists which were previously laid down in the medicines act 1968 for optometrists
provided it is in the course of their professional practice, registered optometrists may sell or supply the following medicinal products to a patient:
- all medicinal products on the general sales list GLS
- all P medicines
provided it is in the course of their professional practice and an EMERGENCY, registered optometrists may sell or supply the following POMs:
- 0.5% chloramphenicol eye drops or 1% eye ointment
- cyclopentolate hydrochloride
- fusidic acid
- tropicamide
how is an emergency defined in the humans medicines regulations 2012 act and how must it be acted upon by optometrists
there is no legal definition of what is an emergency, so the optom has to make a judgement that there is infact an emergency needed and is in the best interest of the patient
which optometrists can sell, supply or write an order for an extended range of medicines
give some examples of medicines
the optometrists who have undergone additional training and are accredited by the general optical council (‘additional supply optometrists’)
- topical antihistamines
- mast cell stabilisers
- NSAIDS
- mucolytic drugs such as: acetyl cysteine
- atropine
- pilocarpine
what is required and what is included in the additional supply ‘The medicines regulations SI 2005 No, 1520
4 points
- further training required
- specialist CET for continued accreditation required
- includes drugs previously designated ‘entry level’
- includes a number of anti-histamines, mast cell stabilisers and the NSAID diclofenic sodium
what 7 things should a signed POM order include
- optometrist’s name and address
- date
- name and address of the patient (if applicable)
- name of the drug
- quantity, pharmaceutical form and strength of the POM (e.g. 0.5% eye drops 10ml)
- labelling directions (where applicable)
- original signature of the optometrist
what form of ink must the signed POM order be in
indelible ink; this includes typewritten and computer-generated orders i.e. computer generated orders must include the original signature
what does the college of optometrists guidance also recommended about signed POM orders
that the optometrist’s signature and GOC number should also be included
list 4 POM medications for administration (as opposed to sale or supply) containing the following substances that are part of the medicines act exemptions
- amethocaine hydrochloride (tetracaine)
- lignocaine hydrochloride (lidocaine)
- oxybuprocaine hydrochloride (benoxinate)
- proxymetacaine hydrochloride
how should a prescription for a medicine be written and what information should it contain
should be written legibly in ink or computer generated and should contain the following information:
- date
- name and address of the patient
- patients age and DOB (a legal requirement in under 12’s)
- name of the drug, dose and number of days of treatment required
- prescribers signature
what is a legal requirement when writing a prescription for a medicine for someone ages under 12
the patients age and DOB
what must happen before a medicine can be used in the uk
it must first be granted a licence
what does a licence that must be issued before a medicine can be used in the uk indicate
that all proper checks have been carried out and the benefits of the medicine are believed to outweigh the risks
what is a licence that is issued before a medicine can be used in the uk also known as
a marketing authorisation
name 2 ways a that licences for medicine can be granted in the uk
- the MHRA which can grant licences for medicines only in the UK
- the European medicines agency (EMEA) which can grant licences for medicines in the European union (EU)
list 4 pieces of information that the licence for a medicine includes
- what health condition the medicine should be used to treat
- the dose, form and who can use the medicine e.g. age restrictions
- how long treatment with the medicine should last
- warnings about known safety issues, such as side effects and interactions with other medicines
