Law Revision Flashcards
Define HSD.
Hub and Spokes Dispensing
When would HSD be legally used?
Used only if the Hub and Spoke belong to the same pharmacy company.
Explain the Windsor Framework.
Introduces UK wide licensing regime to ensure consistency in labelling and packaging across the UK.
From 1/1/25, all new medicines released to the UK market must be clearly legible marking on the outer packaging. This can be done using a stocker until 30/06/25.
Medicines that don’t have a UK MA aren’t required to have UK only mark e.g. unlicensed/imported, specials and extemp.
Medicines purchased by a pharmacy prior to 1/1/25 and without UKMA can still be dispensed if they haven’t reached their expiry date.
What are the legal requirements of FP10?
Rxer’s Signature
Rxer’s Address
Rx Date (Validity = 6 months)
Indication of type of Rxer.
Px Name
Px Address
Px Age if < 12 yrs
What are the legal requirements of FP10D?
Dentists can legally write Rx for any POM.
The GDC advises that dentists should restrict their prescribing to areas of their competence and generally only Rx medicines that are used in dentistry.
Dentists are restricted to the medicines listed in the DPF.
All POM legal requirements apply.
Sch. 2-4 CDs = 28 day validity.
Sch. 5 CD’s don’t need to follow CD requirements.
‘For dental tx only’ = Schedule 2-3 CDs.
CD reg = Schedule 2 = Kept for 2 years in the pharmacy.
Good practice requirement not to supply > 30 days for schedule 2-4 CDs. Query if this exceeds the limit.
Send to NHSBSA at the end of the month.
What are the legal requirements of FP10P?
Community nurse/district nurses can legally write Rx for any POM.
Their regulatory body advises that community nurses prescribers/ district nurses should restrict their prescribing to areas of their competence and generally only Rx medicines that are used in nursing.
Dentists are restricted to the medicines in the NPF.
POM legal requirements apply.
Good practice requirement: No > 30 days. Send to NHSBSA at the end of the month.
What are the legal requirements of Private Rx?
Can Rx any medicines as long as within their area of competence.
Can be written on any form
Legal requirement = POM Register
Schedule 2 and 3 CDs = Not allowed.
Schedule 4 CDs = 28 days validity, good practice to prescribe no more than 30 days supply.
Fate of Rx: Ref. No on Rx, keep in pharmacy for 2 years.
Records: POM register (ref, no, px’s/ prescriber’s name and address, supply date, rx date, medicine name, strength, form, quantity (dose = good practice).
Ref no in POM register, Rx, label.
What are the legal requirements of FP10PCD?
Private controlled drugs Rx only for Schedule 2-3 CDs.
Particulars: Px, full name and address, age / DOB (< 12 yrs), Appropriate date (28 days validity), medicine name/strength/form/ total quantity in words and figures, Rxer’s name, address indication to type, signature, ID number. Pharmacy stamps including initials and supply date.
Good practice requirement not to supply > 30 days.
Records: Schedule 2 (CD register = legal, POM register = good practice.) Schedule 3 (POM register = legal) Ref number needs to be on label, Rx and POM register.
Fate of Rx: Original sent to NHSBSA at the end of the month and copy is kept in the pharmacy.
What are the legal requirements of FP10MDA?
Mainly used for opioid dependence.
Schedule 2-4 CDs are used to replace the drug the px is addicted to.
Legal requirements particulars:
Patient’s full name, address, age/DOB,
Rxer’s type, address, signature.
Appropriate date (28 day validity)
Medicine name, strength ( more than one), form, total quantity in words and figures. Installment direction (amount and interval)
Pharmacy stamps: initial and supply date.
Records: Schedule 2 CDs: CD register = legal. Include quantity supplied on the day and need to fill in right side of the Rx.
Max tx = 14 days.
Fate of Rx:
- Keep in the pharmacy until all installments have been dispensed and send the Rx to the NHSBSA at then end of the month.
Home Office Approved Wording:
- Please dispense instalments due on pharmacy closed days on a prior suitable day.
- Supervise consumption on collection day.
- Dispense daily doses in separate containers
- If an instalment’s collection day have been missed, please still dispense the amount due for any remainder day(s) of that instalment.
- Consult the prescriber if 3 or more consecutive days of a Rx have been missed.
What are the legal requirements of Veterinary Rx?
Particulars:
- Prescriber’s name, address, telephone number.
- Prescriber’s prof. Qualifications
- Owner’s name and address
- Animal’s identication + species
- Animal’s address (if different to owners)
- Rxer’s signature
- Rx date
- Product Name and Quantity
- Dosage + Administration Instructions (as directed = NOT acceptable)
- Any necessary warnings
- Withdrawal period
- If prescribed under the cascade - a statement to show this.
Rx is valid for 6 months unless its a CD Schedule 2-4 =28 days
Schedule 2 & 3 CDs: Specific particulars
- Prescriber’s address
- RCVS registration no of prescriber
- Medicine form, strength, total quantity in words and figures,
- Statement confirming item has been Rx for an animal or herd under the care of vet.
- Px’s name and address
- Instalment dispensing, quantity and interval of instalments.
- Schedule 2-3 CDs repeats AREN’T allowed!.
Records: POM Register = Legal
- Supply date
- Medicine Name (other details)
- Batch no.
- Quantity supplied
- Px name, address (owner and animal)
- Rxer’s name and address
- Ref no present in POM register, label and Rx.
Labelling:
- Pharmacy name and address
- Prescribing vet’s name
- Animal owner’s name and address
- Animal’s identification and species
- Dispensing date
- Expiry date
- Product name
- Dose and administration instructions
- If appropriate, special storage requirements.
- Warnings for user
- For animal treatment only
- Keep out of reach and sight on children.
- Manufacturer’s name and batch no in POM register.
- Expiry date on label
Fate of Rx:
- Stamp Rx including initials, supply date
- Add reference number in POM register, label and Rx.
- Unless it’s a repeat, hand back to px.
What are the legal requirements of Requisitions?
POM Requisitions:
- No legal requirements.
- Ensure person ordering POMs is a qualified person who has the right to possess POMs.
- Kept at the pharmacy for 2 yrs.
- Stamped with date and initials.
- Records: POM register entry is needed, good practice = written requisitions, Legal = verbal. Supply date, prescriber’s name and address and prof. Medicine name, form, strength and quantity, Purpose for POM, Requisition date, ref. Number.
- If a white box or blister pack is on the medicine, expiry date and batch number included on the label.
CD Requisition:
- Legal requirements (Recipient’s full name, address, signature, Profession. Medicine name, form, strength and quantity. Purpose of CD.
- Good practice to have order date and 2 codes (individual prescriber code and practice code)
- Fate: Original sent to NHSBSA at the end of the month. Copy is kept at the pharmacy for 2 years. Stamps with date and initials.
- Records: POM register entry = good practice. (Supply date, person profession/address, medicine name, strength, form, total quantity (dose = good practice), purpose of CD and Requisition date.
If it’s a Schedule 2 CD = CD register (legal)
- Label: add ref number in POM, label and requisition. Name of the person that the medicine is being sold/supplied to. Expiry date, batch number.
What are the legal requirements of emergency supplies?
Px: Limited to 30 days (5 days = CDs)
There’s no Rx coming
Emergency supply on label
Good practice for practitioner’s details.
Px interview = required
Medicine supplied has to be given periodically by appropriate practitioners.
Prescribers: No limit to quantity, good practice for CDs. Rx supplied within 72 hrs. No wording of emergency supply on label. Legal requirements for practitioner’s details. Px interview = not required. Medicine supplied can be new medicine.
What are the legal requirements of wholesale dealing?
Wholesale dealing = sells or supplies it to someone else or administer it to someone else other than themselves.
No need to WDL for a supplying pharmacy providing that the supply of the medicine is to another pharmacy or a HCP for tx or onward supply to px and it:
- Takes place on an occassional basis
- Quantity supplied is small.
- Supple is made on a not for profit basis
- Supply not for onward wholesale distribution.
Requests can be made on a signed order or requisition. No legal requirement of its details and supplying whole packs is recommended.
Records: POM register = legal (no signed order), good practice (with signed order)
Signed order/ invoice kept for 2 years.
Details in POM register (Date of supply, medicine name, quantity, form and strength, purchaser’s name/address/trade/ business or profession.
POM’s purpose.
What are the legal requirements of non-medical prescribing?
IP - Responsible for initial clinical assessment and preparation of a CMP of a px.
- IP’s should be fully trained/accredited, prescribe within their area of competence, have access to the diagnosis when prescribing for existing LT condition or to info on which to base an accurate diagnosis, take responsibility for their actions.
SP - Can take responsibility for px management who has been assessed by IP.
- Must be a HCP that has undertaken an extra period of training and working with an IP.
- CMP must be specific to px and conditions and sets out what responsibilities is delegated, agreed and signed by both prescribers.
- Can Rx any medicine as long as it’s within the CMP.
CMP: ‘Written plan relating to the tx of an individual px.’
- Particulars: px’s name, illness and conditions to be tx, start/review dates, medicine class, Rx restrictions/limitations, px sensitivities, ADR, circumstances when SP should refer to IP or seek advice of IP.
What are the legal requirements of PGD?
A written instruction for the sale, supply and/or administration of named medicines in an identified clinical situation. Applicable to px groups who may not be individually identified before presenting for tx.
Particulars: Organisation name, PGD date/expiration date, medicine details, class of professionals, doctor/dentist and pharmacist signature, appropriate health organisation signature, clinical condition to which PGD applies to, px details who are excluded, when further advice/referral should be sought, dose, route, frequency, duration of tx. Warnings including s/e. Details of any necessary follow-up action, record details to be kept.
Medicines included: All POM, P and GSL, Schedule 2 CDs = Diamorphine, morphine, ketamine. Schedule 3 CDs = Midazolam, any Schedule 4 part 1 CDs, Any S5.
What are the legal requirements of GSL sales?
What are the legal requirements of P sales?
What are the main features of HMR 2012?
What are the main features of licensing?
What are the main features of licensing?
What are the main features of labelling?
What areas where a pharmacist can exercise due diligence?
Explain the main features of the Responsible Pharmacist Regulations 2008.
Explain the main features of the pharmacy profession regulation.
Explain the role of the GPhC.
What are the standards for pharmacy professionals?
Give e.g. of CDs Schedule 2
Give e.g. of CDs Schedule 3
Give e.g. of CDs Schedule 4 part 1.
Give e.g. of CDs Schedule 4 part 2.
Give e.g. of CDs Schedule 5
What are the Rx requirements for CDs?
What circumstances are exempted from CD Rx requirements?
What is the legal validity of CD Rx?
What is the maximum quantity of CD supplied as DHSC recommended?
What details needs to be recorded on CD register?
When do you need to record on CD register?
How are CD registers organised?
What to do if an error occurs when writing on a CD register?
Which CDs are written on FP10MDA?
What dates needs to be recorded on FP10MDA?
What are HOAM?
What is the max number of days supply on FP10MDA?
Explain the main features of supervising px.
Explain the main features of non-supervising px.
What records needs to be recorded on FP10MDA?
Explain how to handle missed doses on FP10MDA.
What are the legal classes of veterinary medicines?
NFA-VPS: Non-food animals that can be supplied by a veterinary surgeon, a pharmacist or a suitably qualified person. A written prescription isn’t required. These medicines shouldn’t be accessible by the public in a pharmacy.
POM-V: POM that can only be Rx by a veterinary surgeon and supplied by a veterinary surgeon or a pharmacist with a written Rx.
POM-VPS: POM that be prescribed and supplied by a veterinary surgeon, a pharmacist or a suitably qualified person on an oral or written Rx. A written Rx is only required if supplier isn’t the prescriber.
AVM -GSL: An authorised veterinary medicines that is available on general sale.
What are the labelling requirements of vet Rx?
What are the record requirements for veterinary Rx?
What is the fate of a Vet Rx?
What are the legal requirements for CD’s of animals?
Explain the main features of the cascade.
A veterinary medicine with a GB or UKMA must be supplied where one exists and is clinically appropriate. It’s unlawful to supply a human medicine against a veterinary prescription unless it’s prescribed by a veterinary surgeon and specifically states that it’s for administration under the cascade.
The cascade is an exemption within the veterinary medicines regulations and specifies that where a licensed veterinary product isn’t available other medicines can be considered.
- Supply a veterinary medicine with a GP or UK-wide MA for the species and condition indicated.
- Where this isn’t possible, a veterinary medicine with a NI MA for the species and condition indicated can be supplied.
- Where this isn’t possible, a GB, NI or UK-wide veterinary medicines that is licensed for another species or different conditions can be considered.
- Where this isn’t possible, A GB, NI or UK-wide licensed human medicine OR a veterinary medicine authorised outside the UK can be considered.
- An extemporaneous or specifically manufactured medicine can be considered.
Explain the main features of emergency supply of patient.
Explain the main features of emergency supply of prescriber.
What are max quantities of emergency supplies?
What are the exemptions for emergency supplies?
What are the labelling requirements for emergency supply?
What are the records requirements for emergency supply?
What are the professional issues for emergency supplies?
