Law and ethics Flashcards
When can GSL medicines be sold in a pharmacy?
-Once a pharmacist has assumed role of RP
Outline the laws for selling ephedrine and pseudoephedrine?
- Cannot sell combination
- 720mg pseudoep
- 180mg ep
Outline the 8 standard prescription requirements
1) Indelible ink
2) Prescriber address
3) Date
4) Prescriber particulars
5) Patient name
6) Patient address
7) Age of patient if under 12
8) Signature
Can prescriptions for schedule 2 and 3 CDs be dispensed if the prescribers address is outside the UK?
- No
- This includes Jersey, Guernsey and Isle of Man
Outline POM register requirements
- Supply date
- Prescription date
- Medicine details
- Prescriber details (Name and address)
- Patient details (Name and address)
What medicines are exempt from POM register record keeping?
- Oral contraceptives
- Schedule 2 CDs
Are prescriptions, prescriber requests for emergency supplies and repeatable prescriptions legally permitted in the UK, if from a Swiss/EEA prescriber?
-Yes
What are the prescription requirements for a Swiss/EEA prescription?
- Patient name, surname, DOB
- Prescriber details (everything)
- Medicine details
- Prescriber signature
- Date of issue
What medicines are invalid on Swiss/EEA prescriptions?
- CD1,2,3
- Medicines without UK marketing authorisation
How soon must a prescription be received from an EEA prescriber after an emergency supply is made?
-72 hours
What is the standard military prescription form and outline its legality
- Fmed 296
- No CDs allowed
- If no MOD contract then must be processed as private script.
What is legally required on a dispensing label?
- Patient name
- Name and address of pharmacy
- Name of medicine
- Directions for use
- Date of dispensing
What does a PSD allow?
-Supply or administration of a medicine to a named patient
Can prescribers outside Europe request an emergency supply?
-No, UK and EEA/Swiss only
What is the maximum quantity of treatment allowed for an emergency supply?
- 30 days for most medicines
- 5 days for CD 4,5 and phenobarbital
What is required on salbutamol/adrenaline supply requests for schools?
- Signed by principle/head
- Name of school
- Purpose of why it is required
- Total quantity required
- POM register entry
- Retain for 2 years
- Appropriately headed paper should ideally be used, but not a legal requirement
What are the regulations of PPP?
- Valid for 7 days
- Maximum of 30 days supply (Unless more agreed with prescriber)
Describe the characteristics of a POM-V
- POMs that can only be prescribed by a vet
- Can only be supplied by a vet or pharmacist with a written prescription
Describe the characteristics of a POM-VPS
- POM that can be prescribed and supplied by a vet, pharmacist or SQP
- Oral or written prescription allowed
- Written script only required if prescriber is not supplier too
Describe the characteristics of a NFA-VPS
- Script for a non-food animal
- Can be supplied by a vet, pharmacist or SQP
- Written prescription not required
Describe the characteristics of a AVM-GSL
-Authorised vet medicine available for general sale
Describe the characteristics of a SAES
-Unlicensed vet medicine that does not require marketing authorisation as it meets exemptions for small pet animals
Describe the characteristics of an unlicensed vet medicine
-Prescribed by vet under cascade only
Outline the 9 vet prescription requirements
1) Name, address, phone no, qualification and signature of prescriber (RCVS no needed for CD2+3)
2) Name and address of owner
3) Identification and species of animal, address (if different to owner)
4) Date
5) Name, quantity, dose and administration instructions of medicine (as directed not acceptable)
6) warnings/withdrawal period
7) Cascade wording
8) CD2+3 “for animal or herd” wording
9) Repeat instructions (All repeats must be made within 6 months or sooner)
Outline the differences vet CD scripts have to human ones
- Standardised forms not required
- Must be retained for 5 years
- 28 days treatment max (30 days for humans) unless justified
- RCVS number required
Explain the veterinary cascade
1) Licensed vet med
2) Licensed vet med for different species/condition
3) Licensed human medicine or EU-licensed vet med
4) Extemp or special product
What are the rules for supply of vet meds in the pharmacy?
-Pharmacist must be physically present, or have pre-authorised transaction beforehand
What additional details must be present on vet med dispensing labels (unless they are on the packaging)?
-Name of prescribing vet
-Name and address of owner
-Expiry date
-“for animal treatment only”
-“keep out of sight and reach of children” (recommended)
-
Are dispensing labels required for all vet meds?
- No, only those prescribed under cascade
- Considered good practice to have them for all
What details are required for record keeping of POM-V and POM-VPS?
- Medicine name
- Date of supply
- Batch number
- Quantity
- Name and address of recipient
- Prescriber details if written prescription
- Retain prescription if written
What is the exemption for supplying a retailer with vet meds, without a wholesale dealers authorisation?
-To relieve a temporary supply shortage
What are the regulations of CD1s?
- Called CD Lic POMs
- License required for production, profession or supply
- Exception is that pharmacist may briefly possess them to destroy or hand over to police.
- If quantity is small and for personal use then patient confidentiality should be maintained
- Examples = LSD, cannabis, raw opium
Describe CD2s
- Called CD POMs
- All cannabis based products for medicinal use are schedule 2 and currently unlicensed
What are CD3s known as?
-CD no reg POMs
Describe CD4s
- Part 1 = CD Benz POMs and includes sativex (Keep record for 6 years)
- Part 2 = CD anab POM
- Prescriber can be outside UK (Not the case for 1,2,3)
Describe CD5s
- Can be either CD INV P or INV POMs
- No prescription requirements and valid for 6 months
Which schedule of CD requires invoices to be kept and for how long?
-CD3 for 2 years
For what schedules of CD are requisitions necessary?
- CD 2 and 3
- Must be marked with supplier
For which schedule of CDs is a license required to import or export?
- CD 2, 3, 4(1)
- CD 4(2) required unless for self administration
It is good practice to retain all CD invoices for how long?
-6 years
Outline travelling rules for CDs
- Personal license not required if carrying less than 3 months supply
- Advised that a covering letter letter signed by prescriber is obtained
What are the legal requirements for a CD requisition?
- Signature of recipient
- Name and address of recipient
- Profession/occupation
- Total quantity of drug
- Purpose of requisition
- Approved form must be used unless requisition within same ward/department/legal entity in same hospital
Can supplies be made against a faxed or photocopied CD requisition?
-No
Can anyone be supplied with a CD 2 or 3 in an emergency without a written requisition?
- Yes, doctor or dentist
- Requisition must be supplied within 24 hours
How are CD requisitions processed?
- Mark with suppliers name and address
- Send original to NHS agency and retain a copy for 2 years
What can a midwife supply order be used for and what are the requirements?
- Morphine, diamorphine and pethidine
- Name and occupation
- Name of patient CD will be given to
- Total quantity
- Signature of appropriate medical officer
Outline CD instalment requirements
- Needs to have amount per instalment and intervals between intervals
- 1st instalment must be made within 28 days of date on script or specified date
- Subsequent instalments must be made as per instructions
What differences exist with private CD prescriptions?
- Must be prescribed on standardised form (unless a vet prescription)
- Prescriber ID number must be present (Different to GMC number)
- Must be submitted to NHS agency (CD 2 and 3s)
- A different form must be used if also prescribing non-CDs
Outline the destruction of patient returned CDs
- CD2, 3 and 4(1)s should be denatured before destroying
- AW not required, but good practice to be witnessed by staff or another HCP
- Record in a separate register if CD2
Outline the destruction of expired, obsolete or unwanted CDs
- CD2, 3 and 4(1)s should be denatured before destroying
- Destruction must be witnessed by AW (CD 2)
- Destroy CD 3 and 4 as per patient returns
- Make entry for CD2s into CD register
When can a statuary medical defence be raised regarding driving offences?
-Only when there is evidence the drug has been taken in accordance with prescriber instructions/PIL and when driving has not been impaired
What info must the RP notice contain?
- Name of RP
- GPhC reg number
- The fact that the RP is in charge at this time
What info must the pharmacy record contain?
- RP name and GPhC number
- Date and time RP assumed and ceased
- Date of any absence and time left and returned
How long must the pharmacy record be retained for?
-5 years
How long can an RP be absent for in 24 hours?
- 2 hours
- 2 hours total even if more than 1 RP