Pharmacy law Flashcards
Maximum supply of pseudoephedrine and ephredine
720mg pseudoephredine
180 ephredine
In practice, how many non-effervescent tablets and capsules of paracetamol and aspirin can be sold OTC at any one time?
Most OTC pack sizes come in 16 and 32, so in practice the maximum number that be sold is 96
How many codeine/dihydrocodeine capsules/tablets can you sell OTC?
<32
What statement should the label state on a box of codeine/dihydrocodeine say?
‘Can cause addiction. For three days only.’
What are the standard seven prescription requirements?
1) Signature of prescriber (can be electronic)
2) Address of prescriber
3) Date - valid for SIX months
4) Particulars - e.g Type of practitioner
5) Pt name
6) Pt address
7) Age if under 12
Can you supply an advanced supply of EHC?
Yes - prior to unprotected sexual intercourse or in case of failure)
Patient should be assessed to ensure that are competent
If there is no number of repeats stated on a private prescription, how many can you dispense (and contraception)
You can repeat it ONCE (dispensed twice)
COC - repeat FIVE times (dispensed 6 times)
What controlled drugs can be repeated and which ones cannot?
Schedule 4-5 repeateable
Schedules 2-3 not repeatable
What is the legal time limit that the repeats have to be made?
Non CD - First dispensed within 6 months and no time limits for repeats
CD - First dispensed within 28 days and no time limits for repeats
Even though no legal time limit for repeats - pharmacists should use professional judgement
How long must private prescriptions for a POM be kept?
TWO years from the date of supply or for repeatables from the date of the last sale or supply
How long do POM registers have to be kept?
2 years from the date of the last entry
Where do private prescription CD 2-3 have to be submitted to?
The relevant NHS agency
What must the POM record include?
1) Supply date
2) Rx date
3) Medicine details - name, quantity, formulation and strength
4) Prescriber details - the name and address of the practioner
5) Patient details - the name and address of the patient
What is FMD and what does it aim for? How is it done?
Falsified Medicines Directive.
Aims to create a system that ensure medicines supplied in the UK are safe.
It ensures the trade in medicines is controlled to reduce the risk of fake medicines entering the medicines supply chain and reaching patients
1) New security features on pack
2) New electronic scanning authentication process to be undertaken at point of dispensing
Are EEA countries and Switzerland legally recognised in the UK?
What cannot be prescribed on these prescriptions?
Yes
1, 2, 3 CDs and medicinal products without a marketing authorisation valid in the UK
Can you supply emergency supply at the request of an EEA or Swiss prescriber?
Yes
Standard emergency supply process
If EEA or Swiss emergency request from prescriber - when does Rx need to be received? (This is same for normal emergency supply)
Within 72 hours
Legal requirements on a label
1) Name of patient
2) Name and address of supply pharmacy
3) Date of dispensing
4) Name of medicine
5) Directions for use
6) Precautions for use
7) Precautions relating to use of medicine
What requirements do RPS recommend being on dispensing label but not legal requirement
1) ‘Keep out of reach and sight of children’
2) ‘Use this medicine only on your skin’ where applicable
Can diamorphine/morphine be prescribed under a PGD
Yes - if necessary treatment of sick or injured persons
What drugs cannot be supplied in an emergency supply
Schedules 1-3, except phenobarbital for treatment of epilepsy
What details need to be written in POM register for emergency supply? (If made at request of prescriber)
1) The date the POM was supplied
2) The name and quantity
3) The name and address of the prescriber requesting the emergency supply
4) The name and address of the pt of whom POM supplied
5) The date on the Rx
6) The date on which the RX received
Conditions that need to be met when an emergency supply is made at request of patient?
- Interview (may not always be feasible)
- Immediate need
- Previous Tx
- Dose
- Not for CDs, except phenobarbital
- Length (schedule 4 and 5, max 5 days, any other POM no more than 30 days)
What details need to be written in POM register for emergency supply? (If made at request of patient)
1) The date the POM was supplied
2) The name and quantity
3) The name and address of the pt of whom POM supplied
4) Nature of emergency
Extra labelling requirement for emergency supply made at request of patient
‘Emergency supply’
Who can provide a signed order for salbutamol inhalers/adrenaline autoinjectors (AAI) for a school?
By the principal or head teacher
What information should be included in this signed order” (salbutamol inhalers/AAIs) + which info is ideal but not a legislative requirement
- The name of the school
- The purpose for which product required
- The total quantity required
- Signature of the principal/head
- Ideally appropriately headed paper should be used but not legal
How long does the signed order for salbutamol inhalers/AAIs need to be kept? (what else instead)
2 years from the date of supply
OR an entry can be made in the POM register
What must the POM register include if salbutamol inhaler supply made?
- Date POM supplied
name, quantity and strength - name and address of person who who med supplied
- purpose of supply
How long before pregnant when taking retinoids?
At least 1 month
How long are prescriptions valid under PPP?
What is max quantity supplied?
(retinoids)
7 days
Max 30 days
What should pharmacists do regarding patients on sodium valporate?
- Have a conversation with female patients of child-bearing age prescribed valporate to find out if they had a review with their doctor and are aware of risks and on PPP
- Those planning pregnancy should schedule appointment with prescriber and continue with contraception whilst on valporate
- If there is an unplanned pregnancy whilst on valporate - NOT stop treatment and urgently see prescriber for view
- Report any suspected side ffects to yellow card scheme
List the types of veterinary medicine classes
POM-V - POM that can only be prescribed by a veterinary surgeon and supplied by a vet surgeon or a pharmacist with a written Rx
POM-VPS - POM that can be prescribed and supplied by a veterinary surgeon, a pharmacist or a suitably qualified person on an oral or written prescription. A written Rx is only required if the supplier is not the prescriber
NFA-VPS - A category of medicine for non-food animals that can be supplied by a vet surgeon, pharmacist or suitable qualified person. A written RX not required.
AVM-GSL - An authorised vet med that is available on general sale
Rx requirements for a veterinary Rx
Telephone of prescriber
Name and address of the owner
Species of the animal, and its address if different to the owner
Name, quantity, dose, administration instructions and relevant warnings for medicines
‘Prescribed under the veterinary cascade’
Washout period if for food animal
If a CD: the vet’s RCVS number, and ‘the item has been prescribed for an animal or herd under the care of the veterinarian’
How long are veterinary Rx valid for and CDs
Valid for 6 months
CD 28 days (2, 3, 4)
Differences between vet and human CD Rxs
1) Standardised forms not required for vet Rx - but must state that medicines are ‘prescribed for the treatment of an animal or herd under my care’ for CD 2-3
2) Standardised forms required for human private prescriptions for 2-3
3) Vet Rx should be retained for 5 years not submitted to the relevant NHS agency. Original human prescriptions for sch 2-3 must be submitted to the relevant NHS agency.
4) Highly recommended that the Max supply for CDs is 30 days for humans, good practice for 28 days vets
5) Sch 2 + 3 vets must have RCVS. Human 2 + 3 prescriber identification number
Pharmacies that supply POM-V and POM-VPS need to undertake what each year?
An annual audit
Classification of controlled drugs
Sch 1 - Have no therapeutic use and a licence is generally required for their production, possession and supply
Sch 2 - Pharmacists and other classes of person have authority to possess supply and procure.
Includes opiates (diamorphine, morphine, methadone, oxycodone, pethidine) and major stimulants (amfetamines)
Sch 3 - Minor stimulants and other drugs (buprenoprhine, tramadol, temazepam, midazolam, phenobarbital), that are less likely to be abused.
Sch 4 - Part 1 (CD Benz) - Contains most of the benzos, non beze hypnotics and Sativex
Part 2 (CD anab) Contains most of the anabolic and androgenic steroids, celbuterol and GH