U1 L1 & L2 Sale And Supply Flashcards
When was the Responsible Pharmacist introduced?
2008
What is the main responsibility of the RP?
To ensure the safe and effective running of the pharmacy
What must be included on the RP notice?
Name and registration
What is included in a pharmacy record?
- Name
- Date
- GPhC number
- Time signs in and out
How long must a pharmacy record be kept?
5 years after the last entry or forever if electronic
Under what circumstances is a pharmacy able to run without an RP present?
- RP is contactable
- Pharmacy runs safe and effectively without RP
- RP able to return quickly
How long can an RP be absent in a given 24 hours?
2 hours
What are other members of staff able to do while the RP is absent?
- assemble medications if competent
- sell GSL meds
- take prescriptions with permission from RP
Without the presence of a second pharmacist, staff cannot …
- sell P meds
- hand out prescriptions
What is the Human Medicines Regulation of 2012?
Regulation stopping sale of ineffective or dangerous drug formulations
How does the Human Medicines Regulation define ‘medicinal product’?
Any substance or combination of substances presented as having properties of preventing or treating disease in human beings
What are marketing authorisations? (product licenses)
Allow for manufacture and sale of medicinal products
(Having ensured the product has met standards for safety, quality, efficacy)
Where are marketing authorisations obtained from?
MHRA - Medicines and Healthcare Regulatory Agency
What is meant by ‘off label’ medicines?
Medicines that can be used outside the terms of the MA e.g. aspirin
When is it acceptable to use unlicensed medications in the UK?
- licensed from outside the EU
- unlicensed but manufactured in UK
- non-medicines e.g. supplements
What are the characteristics of GSL meds?
- short term and generally safer
- no need for pharmacist present
- label does not need GSL
- must be sold in original, unopened containers
What are the characteristics of P meds?
- supplied from registered pharmacy under pharmacist supervision
- must contain P in box on packaging
- must not be available for self selection by public
What are the characteristics of POM?
- usually long term use and increased risk
- usually only on provision of prescription
- supplied by registered pharmacy directly by or under supervision of pharmacist
- label must contain POM in box
Under what circumstances can POM be given without prescription?
- emergency supply (in advance of prescription)
- patient group directions e.g. prescribers giving morning after pill
POMV
Prescription only medicines for veterinary
AVM-GSL
Authorised vet medicine general sales list
pack size Paracetamol and 325mg Aspirin as GSL
Max pack size 16
pack size Paracetamol and 325mg Aspirin as P
Max pack size 32
pack size Paracetamol and 325mg Aspirin as POM
Anything over 100
pack size 75mg Aspirin as GSL
Max pack size 28
What two active ingredients cannot be sold together?
Pseudoephedrine and ephedrine
Ephedrine for P
180mg max
Pseudoephedrine for P
720mg max
Co-codamol as P pack size
Max pack size 32
What are the five legal requirements for an NHS or private Rx?
- Patient name and address
- Age or date of birth (both if under 12)
- Prescriber signature
- Date within 6 months
- Prescriber details
What is included in the prescriber details on a Rx?
- name
- registration number
- address
- contact details
What legal errors on a Rx can a pharmacy amend?
Name, address, age or d.o.b.
What is needed to be considered sufficient information with regard to a medicine on a prescription?
- strength
- quantity
- dose
- dose frequency
What must be included on the POM register?
- patient name and address
- prescriber name and address
- medication prescribed name, quantity, strength, form
- date on Rx
- reference number
- date of dispensing
What must dispensing labels contain?
- Patient name
- Drug quantity, name, form, strength
- Directions for use
- Cautionary labels (if applicable)
- Keep out of reach and sight of children
- Address of pharmacy
- Date of dispensing
What is EPS?
Electronic prescription service
How does EPS work for repeat prescriptions?
Sends Rx from GP to patient choice of pharmacy
How does EPS benefit patients?
- patient choice of pharmacy e.g. close to work, home
- no need to pick up paper prescription from GP
- saves time therefore more time for patient appointments
How does EPS benefit pharmacies and the NHS?
- saves time, storage and money
- Rxs cannot get lost between GP and pharmacy
- improved stock control; eRD downloaded 7 days early therefore prep time
What does eRD stand for?
Electronic repeat dispensing
What is meant by ‘acute’ prescription?
Medicine issued by GP but not added to repeat Rx record
What Rx can be EPS?
Acute or repeat Rx in primary or secondary care
What cannot be prescribed under EPS?
- schedule 1 controlled drugs
- medicines outside of NHS Dictionary of Medicines and Devices (dm+d)
- private prescriptions
- items for personal admin
- instalment prescribing (FP10MDA)
What is a post-dated Rx?
A Rx written to be filled at a later date
What happens to post-dated Rxs in the EPS?
Post-dated Rxs are held locally within the system and automatically sent to the pharmacy system on the specified date
the content of a post-dated Rx on the EPS cannot be viewed by the pharmacy prior to the specified date meaning…
- information regarding the Rx cannot be checked by the pharmacy prior to the date
- the Rx cannot be prepared in advance
An alternative use of post-dated EPS Rxs may be
The eRD
What controlled drugs can be given via EPS?
Schedule 2 and 3
What is different about prescribing oral liquid methadone as EPS?
A paper FP10 Rx needs generating so that the pharmacy can collect the correct fees
What are some uses of controlled drugs?
- pain relief
- palliative care
- epilepsy
- alcohol and drug withdrawal
- methadone substitution
What are the five classes of controlled drugs?
- Schedule 1: CD Lic (highest control)
- Schedule 2: CD POM
- Schedule 3: CD No Register
- Schedule 4: CD Benz and CD Anabolic
- Schedule 5: CD Inv
Safe custody requirements for all schedule 2 CDs except
Quinalbarbitone
Schedule 1,2,3, and 4 Rxs are valid for how long?
28 days
Records of supply of Schedule 2 CDs must be kept in the
Controlled drugs register
Schedule 5 Rxs valid for
6 months
Emergency supply of Schedule 1,2 or 3 cannot be made except for
Phenobarbitone for treatment of epilepsy
A veterinary medicine is defined as any substance …
Presented as having properties for treating or preventing disease in animals or that may be used for either restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis
POM-V characteristics
- only prescribed by a veterinary surgeon
- supplied by a veterinary surgeon or pharmacist with written Rx
- clinical assessment of animal by vet required
POM-VPS meaning and characteristic
POM that can be prescribed and supplied by a vet surgeon, pharmacist or suitably qualified person upon oral or written Rx
When is a written Rx needed for POM-VPS?
If the supplier is not the prescriber
NFA-VPS characteristic
Medicine for non-food animals
Can be supplied by vet surgeon, pharmacist or suitably qualified person
Written Rx not required
AVM-GSL characteristic
An authorised veterinary medicine that is available on general sale
A pharmacist prescribing/supplying POM-VPS or NFA-VPS must
- advise safe admin of product
- advise of warnings and contraindications on label, leaflet
- be satisfied that the person administering is competent and intends for correct use
- prescirbe
What is The Cascade Exemption?
Allows for supply of human medicines not otherwise licensed for use in animals
Under what circumstance can a human medicine lawfully be supplied against a Veterinary Rx?
- if it is prescribed by a Vet
- Rx specifically states ‘for administration under the Cascade” or wording to this effect
What are the stages of the Cascade?
- When not possible to supply a licensed vet med, consider existing vet med for another species/condition
- When above not possible an EU or UK licensed human med can be considered
- When above not possible, extemporaneous or specially manufactured med can be considered
What are the three types of Rx collection and/or delivery service?
- Standard Prescription Collection Service
- Managed Prescription Collection Service
- Delivery Service
All governed by GPhC
How does the Standard Prescription Collection Service work?
Pharmacy receives Rx from someone other than the patient or their representative
E.g. is collected by driver/pharmacy staff
Under the Standard Prescription Collection Service, what four things must the pharmacy do?
(This is the same for MPCS)
- Obtain consent to receive patient Rxs
- Explain to patient/carer what service involves, when to collect Rxs
- Ensure Rxs collected by persons in accordance with pharmacist’s directions
- Have procedures to safeguard confidentiality and security
What are three rules regarding the process of the Standard Prescription Collection Service?
- Request for ongoing service must be direct from patient or carer (ideally in writing)
- On receipt of Rx the pharmacist must ensure they are authorised to receive and dispense
- Any Rx received without consent to be returned to GP
How does the Managed Prescription Collection Service differ from the Standard Prescription Collection Service?
For MPCS the patient does not prompt the pharmacy to order their repeat RX
But
The pharmacy will prompt the patient to establish what meds are needed and when meds are ready to collect
How does using Managed Prescription Collection Services benefit the pharmacy?
- allows 7 days to order and dispense Rx
- reduces wastage
- increases compliance
- secures a patient’s repeat custom
How do Prescription Delivery Services work?
Medicines are handed to the patient/carer someplace other than the registered pharmacy premises e.g. their home
What are three considerations to ensure best practice for Prescription Delivery Services?
- Pharmacist has responsibility to ensure patient knows how to safely use meds, have no side effects or compliance issues
- Pharmacist must obtain consent to receive and dispense, preferably in writing
- Appropriate records must be kept
For what types of drugs must the pharmacist exercise caution supplying via Prescription Delivery Services?
Drugs requiring frequent blood level monitoring e.g. warfarin
What are some responsibilities of the pharmacist regarding Prescription Delivery Services?
- ensure prompt delivery with use instructions
- meds handed to patient/carer unless said otherwise
- confirm patient name, address
- cater for special storage requirements
- clear audit trail, confidentiality safeguards
- obtain signature upon delivery
What forms are involved in Batch Repeat Dispensing, RPD?
- Repeat Dispensing Rx - authorising Rx (for 2.) - marked ‘RA’
- Repeat Dispensing issue forms - marked ‘RD’
How long are RD issue forms valid for?
Up to 12 months
What does patient supply to chosen pharmacy to begin BRD?
Both the authorising repeat dispensing Rx and first RD issue form
Who keeps the remaining RD issue forms?
The patient or the pharmacy
What happens when the patient uses the last RD issue form?
The pharmacy will prompt the patient to revisit the GP for a new set of RP forms along with a new RA Rx
What if the patient already has a sufficient supply of a medication on the RD?
The pharmacy does not have to supply every med on the form with each RD issue
What type of patient is best suited to BRD?
Patients on a stable long-term treatment e.g. those with a chronic illness
What are the benefits of BRD to the patient?
- more patient centred approach via increased control and ownership of Rx
- minimal need to visit GP
- regular opportunities to discuss medications and associated issues with a pharmacist
What is the the benefit of BRD to the pharmacy?
Reduced workload
Why are faxed Rxs risky?
- not legally valid because not indelible ink, not signed by appropriate practitioner
- associated with misinterpretation, fraud etc
When may faxed prescriptions occur?
Emergency supply
Should a faxed prescription be used, what must be done?
- Ensure integrity of original Rx e.g. phone surgery
- Make arrangements to get original Rx ASAP
Supply of what drugs without possession of a lawful Rx could be prosecuted as a criminal offence?
Schedule 2 or 3 Controlled Drugs
Most medicine wholesalers are required to have what sort of licence according to the MHRA?
Wholesale Dealer’s License - WDA(H)
In order for pharmacies to remain exempt from needing a Wholesale Dealer’s License when supplying to other HC professionals, what is required?
- supply must take place on occasional basis
- small quantities supplied
- supply on a not for profit basis
- supply not for onward wholesale distribution
For what three instances do pharmacies not require a Wholesale Dealer’s License?
- To supply meds to UK public and others authorised to receive meds
- To obtain small quantities of meds from another pharmacist to meet needs of individual patient
- To supply meds to other UK HC providers who hold meds for treatment and supply
What is a Signed Order?
A document needed to allow a registered pharmacy to supply POMs to HC professionals
When a pharmacy supplies POM to another HC professional what must be done?
An entry must be made to the POM register
OR
The Signed Order/invoice must be retained for 2 years from date of supply
What must be included in the POM register entry if medicine supplied to a HC professional?
- date of POM supply
- name, quantity and formulation and strength
- name and address, trade, business etc of person to whom POM was supplied
- purpose of supply
What six other circumstances allow the sale or supply of POMs without a prescription?
- Emergency injections
- Pandemic exemptions
- Optometrist/podiatrist signed orders for patients
- Supply of Salbutamol inhalers to schools
- Supply of adrenaline autoinjectors to schools
- Supply of naloxone to individuals providing recognised drug treatment services
What is meant by ‘repeatable’ Rx?
The instance where a prescriber adds an instruction for the prescribed item to be repeated ie. Supplied more than once against the same form
What schedules of Controlled Drugs are repeatable for private Rxs?
Schedules 4 and 5
(Not 2 or 3)
Within how many days must schedule 4 Controlled Drugs be dispensed for Private Scripts?
28
For most private repeatable Rx (including Schedule 5 CDs), within how long must the first dispensing be made?
6 months
What is the legal time limit for the remaining repeats after the first dispensing of a repeatable private Rx?
There is no legal time limit
How many total times would a medicine be dispensed if Rx repeated 5x?
6 total dispenses
How many times can a repeatable Rx be dispensed if number of repeats is not stated?
Once
What is the exception regarding only repeating the dispense of a repeatable Rx once if the number of repeats is not stated?
Oral contraception, one month supply
Can be dispensed 6 times (repeated x5) within 6 months of appropriate date
How is an audit trail of a repeatable Rx maintained?
Pharmacist at time of supply advised to mark on Rx
- date
- name and address of pharmacy
- indication as to which number of dispensing was made
How are records of NHS Rxs kept in Wales?
PMR - Patient Medication Record
Rx sent to NHS Wales Shared Services Partnership (NWSSP) at end of month
How are records of NHS Rxs kept in England?
PMR - Patient Medication Record
Rx sent to NHS Business Services Authority (NHSBSA) in England
How long is the POM kept for?
2 years after last entry
What must be included on POM register entries for private Rxs only?
- Price paid (no VAT added)
- stamp script with branch stamp
Rxs for what POMs are exempt from record keeping via POM register?
- oral contraceptives
- Schedule 2 Controlled Drugs (ONLY where a separate CD record is made)
