A very concise set of notes covering the important aspects of law required to pass the GPhC exam. Topics include:
- Prescription requirements (private, vet, EEA & Swiss)
- Emergency supplies
- Controlled Drugs (CDs)
- OTC product laws
- Pregnancy Prevention Programmes (PPPs)
- Responsbile pha...
PRIVATE RXs REQUIREMENTS:
- Prescriber’s particulars (name, type, GMC no., contact details)
- Prescriber’s signature in INDELIBLE INK
- Patient’s particulars (full name and full address – DOB needed if under 12)
- Date of prescription (i.e. when it was written)
- Full details of the medicine (name, form, strength, dose, quantity, additional admin
requirements)
PRIVATE CD RXs (Sch.2 & 3 CDs):
Same requirements as above, but with additional measures:
- Must use standardised FP10PCD pink Rx form – so the NHS can keep track of Sch.2-3
CDs prescribed in private sector – FP10PCD forms are the only private Rxs to be sent
to NHS BSA (good practice to keep photocopy of pink script for own records)
- Must have prescriber identification number on FP10PCD - prescribers can obtain
this from their local health authority
- Can NOT repeat items on FP10PCDs
- Total supply must NOT exceed 30 days of treatment
- Total quantity must be written out in numbers AND words
- Non-Sch.2-3 CDs can NOT be prescribed on the FP10PCD – if this does happen e.g.
the prescriber adds paracetamol to the pink script, they must issue a new FP10PCD
with paracetamol on a regular private script.
REPEATABLE RXs (NOT Sch.2 & 3 CDs):
- If Rx just says ‘repeat’ (without specifying the number of repeats), then an initial
supply is made, followed by one repeat (totalling to 2 supplies)
- If the number of repeats is specified, then the total number of supplies will be the
no. of repeats +1 (as we account for the initial supply)
- The first supply must be collected within 6 months (EXCEPTION – Sch. 4 CDs = 1st
supply collected within 28 days), but subsequent repeats can theoretically be
collected at any time (i.e. there is no expiration date), however use clinical &
professional judgement to assess whether the patient needs this repeat (if they
haven’t collected for a while – this may mean contacting their prescriber)
- Oral contraceptives - total of 5 repeats can be made (i.e. six total supplies) – do NOT
need to write ‘repeat x5’ – just ‘repeat’ by itself means 6 supplies can be made (for
oral contraceptives ONLY)
- Sch.2-3 CDs CANNOT be repeated (both for NHS and private Rx) – if it does say
repeat, then just dispense and supply once only (i.e. ignore the repeat)
- To keep track of the number of supplies made, stamp the Rx each time a supply is
made (best to do this immediately after supply) – next to the stamp write down the
level of dispensing (e.g. was that the first supply, first repeat etc.)
- Patients have the option to take their Rx back (even if they’ve got some repeats left
on that Rx) – they can take this to another pharmacy to continue the remaining
repeats (or they may ask you to keep it)
, THE POM / PRIVATE REGISTER
RECORD KEEPING (in the POM/private register):
- There is no standardised system for private Rx record-keeping – so can be paper or
digital – but these records must contain specific information:
o Date the Rx was written
o Date the meds were supplied
o Patient particulars (full name and full address)
o Prescriber particulars (name, contact details, GMC no., sigature)
o Medicine particulars (name, strength, form, quantity)
o Cost of the Rx
- Repeatable items – don’t need to re-enter all the info for subsequent supplies – only
need to make a note of the supply date (ensuring this is being linked back to the
initial entry for that repeatable item)
- Entries into the private register (aka the POM register) must be made on the day of
supply, or the next day latest
- Records must be kept for TWO YEARS
WHICH DRUGS LEGALLY REQUIRE ENTRY INTO POM REGISTER:
- All POMs EXCEPT for Sch. 2 CDs and oral contraceptives require entry
- Sch. 2 CDs are ‘register CDs’ i.e. they require entry into the CD register (unlike Sch. 3
CDs) – since these drugs are already being recorded elsewhere, there’s no need to
enter them in POM register again
- Oral contraceptives don’t require entry (no particular reason)
- Although it’s good practice to enter all medicines from private Rxs into the private
register, it’s NOT legally required for all medicine classes, including P meds
EUROPEAN ECONOMIC AREA (EEA) & SWISS PRESCRIPTIONS
INTRO:
- EEA & Swiss Rxs CAN be dispensed in UK if they’re legally & clinically valid
- Sch.1-3 CDs can NOT be prescribed/dispensed here
- Medicines WITHOUT UK marketing authorisation (MA) can NOT be dispensed in UK
WHICH EEA/SWISS PRESCRIBERS CAN WE ACCEPT RXs FROM:
- Non-exhaustive list of foreign prescribers, including:
o Doctors, Dentists, Nurses, Pharmacists, Podiatrists, Physiotherapists etc.
- Best practice to check if these clinicians have prescribing rights in their home
country, e.g. nurses may be able to prescribe in the UK, but not in other countries
EEA/SWISS RX LEGAL REQUIREMENTS:
- Almost exact same requirements that apply to private Rx – EXCEPT Sch.1-3 CDs and
drugs without UK marketing authorisation can NOT be dispensed
- Sch.4 CDs CAN be dispensed, but must be collected within 28 days of Rx date (like in
NHS and private scripts)
, - Patient particulars – Address is NOT a legal requirement (since diff countries have
diff legal requirements, but their DOB is a legal requirement)
- Prescriber particulars – full name, type of prescriber, address with country of origin,
and direct contact details e.g. phone no., fax, or email.
- Must have prescriber signature in indelible ink
Even if the prescription is written in a foreign language, you can still use your clinical
judgment to decide whether you want to dispense the meds or not
If for any reason you refuse to dispense an EEA/Swiss Rx, then you should refer the
patient to a UK prescriber
EEA/SWISS RX RECORD-KEEPING:
- These Rxs are private scripts – so they’re registered into the POM/private register
with the same requirements as any other private script
EMERGENCY SUPPLY FOR EEA/SWISS Rx – YES, they can be made (at request of prescriber
/ patient)
EMERGENCY SUPPLIES (ES) - UK PRESCRIPTIONS
INTRO:
- ES can either be made at the request of:
o The prescriber
o The patient
1- ES AT PRESCRIBER’S REQUEST – LEGAL REQUIREMENTS:
- Must be an appropriate prescriber (i.e. licensed physician)
- Must be satisfied that a prescription cannot be issued to the pharmacy at the time of
request i.e. must be an emergency
- Prescribers can be any prescriber in UK or EEA/Switzerland with prescribing rights
- RX must be issued within 72 hours of the ES-request
- Medicines must be supplied in accordance with direction from the prescriber
- ‘Emergency supply’ must be included on the dispensing label
- Can NOT give ES for any Sch.1-3 CDs (EXCEPT for phenobarbital for epilepsy in UK)
EXCEPTIONS TO ES RULES:
- Phenobarbital is a Sch.3 CD but can still be given as ES when used for epilepsy
- This exception ES made by UK prescribers ONLY – not applicable to EEA/Swiss HCPs,
since we don’t accept ANY Sch.1-3 CDs from them
- EEA/Swiss HCPs can request ES for other drugs (only if that drug has a valid UK MA)
RECORD KEEPING REQUIREMENTS OF ES (PRESCRIBER’S REQUEST):
- 3 dates per entry:
o The date the ES was made
o The date the follow-up Rx was received (must be within 72 hours of ES)
o The date on that follow-up Rx (i.e. when it was written)
- Prescriber particulars (Name, address, GMC no.)
- Patient particulars (Name, address)
- Medicine particulars (name, strength, form, quantity)
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