Pharmacy Law Flashcards
For a pharmacist who qualified outside the EEA (do not have relevant European qualifications), what do they need to do to register?
Apply for registration via GPhCs overseas registration process
Who is the GPhCs overseas registration process intended for?
Pharmacist applicants who qualified outside of the EEA
do not have European qualifications
What is the process for a UK pharmacist applying to work in an EEA country?
Apply in the same way as an applicant from outside the EU
What is the effect of EU Falsified Medicines Directive on UK pharmacy?
Regulatory requirements no longer apply to pharmacy owners/ professionals supplying medicines in the UK
What is the effect of EU Mandated Distance-Selling Logo on UK pharmacy?
Negotiations currently ongoing at MHRA
GPhC voluntary internet pharmacy logo is unaffected
Are prescriptions from the EEA/ Switzerland still valid?
Allowed only IF issued by an approved HCP in an approved country
Are emergency supplies for patients of EEA/ Switzerland HCPs valid?
Yes
Are prescriptions from an unapproved country/ HCP valid?
No
Use professional judgement to find a solution for patient
What are the prescription requirements from an approved HCP?
(1) Patient details
- name
- DOB/ address
(2) Prescriber details
- signature
- qualification
- GP address
- Professional qualifications
- telephone/ FAX
(3) Date of issue
- ≤6 months
- 28 days for CD4
Is a prescription written in a foreign language valid?
Yes
Provided that enough information is given for safe supply of medicines
What is the prescription charge waiver, with regard to COVID-19?
Antiviral medicines to be supplied free of charge until 31/03/22
What is the Medicines and Medical Devices Act 2021?
New act to provide powers to amend the Human Medicines Regulations, Veterinary Medicines Regulations, and other legislation
Permits independent pharmacies to outsource dispensing to a different retail pharmacy business
What are the core duties of the Patient Safety Commissioner?
- Promote safety of patients with regard to medicines and medical devices
- Promote the importance of the views of the patients and other members of the public, in relation to medicines and medical devices
What is Hub and Spoke dispensing?
Hub received prescriptions from multiple spokes.
Hub assembles prescriptions and sends prescriptions to spokes
Spokes dispense prescriptions to patients
What is a ‘Hub’?
Pharmacies registered with the GPhC for DISPENSING
What is a ‘Hub’?
Pharmacies registered with the GPhC for DISPENSING
What are Caldicott Guardians?
Senior person within a health/ social organisation
Ensures personal info of patients is used legally, ethically and appropriately
To maintain confidentiality
What is the legislation regarding Summary Care Records (SCRs)?
Ensure staff working at your pharmacy can access SCRs reliably during opening hours
Can only be accessed by pharmacists and pharmacy technicians
Who can access Summary Care Records (SCRs)?
Pharmacists OR pharmacy technicians
What is the legislation regarding EPS failure?
Where a contractor is unable to access the EPS they must take all reasonable steps to ensure the item is supplied within a reasonable timeframe, e.g.
(1) Signpost patient to another pharmacy
(2) Make urgent supply at request of a prescriber
(3) Contact the prescriber and ask for urgent provision of a non-electronic prescription form
What does HLP stand for?
Healthy Living Pharmacy
What are the requirements for consultation rooms?
Almost all pharmacies need one
Exceptions are small pharmacies and distance-selling pharmacies
Must provide confidential telephone/ live audio link AND video link
Which pharmacies do not require consultation rooms?
(1) Distance-selling pharmacies
(2) Small pharmacies
What is a DSP?
Distance-selling pharmacy
What is a Healthy Living Pharmacy?
(1) Health + wellbeing ethos
(2) Local stakeholder engagement
(3) Consistent high quality service
(4) Health-promoting environment
(5) Trained health champions on site
(6) Pharmacy leadership
(7) Caters to public health needs of community
(8) Proactive/ friendly/ approachable staff
(9) Innovative initiatives + delivery
(10) Community hub
What are the stages of the veterinary cascade?
(1) Supply vet med for species + indication
- GB/ UK wide MA
(2) If not possible, Northern Ireland MA for species + indication can be supplied
(3) If not possible, vet meds for another species/ indication can be considered
(4) If not possible, vet/ human med licensed outside of UK can be considered
(5) If not possible, an extemporaneous/ specially manufactured med can be considered
What is an extemporaneous medication?
Medication made specially by a pharmacist when another is not available
What is the guidance on providing pharmacy services to friends and family?
(1) Emergency?
(2) Signpost to alternative providers?
(3) Can you maintain objectivity/ professional judgement
(4) Can confidentiality be maintained
(5) Can transparency be maintained
What is the Botulinum Toxin and Cosmetic Fillers Act 2021?
(1) Criminal offence to administer botox to <18yrs for cosmetic purposes in England
(2) Offence to make arrangements for botox treatments for <18yrs
When can Botox/ cosmetic fillers be administered to someone <18yrs?
When approved under the directions of a doctor
How can the Botulinum Toxin and Cosmetic Fillers Act 2021 be enforced?
(1) Verify age before booking appointment
(2) Verify age before administering treatment
How are ‘cosmetic fillers’ defined?
Subcutaneous/ submucous/ intradermal injection of filler where the likely effect of injection is to change the appearance of the patient injected
What is the Community Pharmacy Contractual Framework (CPCF)?
3 different types of pharmacy services
(1) Local
(2) Advanced
(3) Essential
What are some advanced pharmacy services?
(1) Appliance use review
(2) Stoma appliance customisation
(3) New medicine service (NMS)
(4) Flu vaccination service
(5) Community pharmacist consultation service (CPCS)
(6) Hepatitis C testing
(7) COVID-19 lateral flow device distribution service
(8) Hypertension case finding service
(9) Stop smoking advanced service
What is the COVID-19 lateral flow device distribution service?
Advanced pharmacy service
‘Pharmacy Collect’
Allows asymptomatic people to collect LFD test kits for free
One box per person
Max 2 boxes per transaction
What is ‘Pharmacy Collect’?
COVID-19 lateral flow device distribution service
Advanced pharmacy service
What is the ‘Hypertension Case Finding Service’?
Advanced pharmacy service
New from 1st Oct 2021
For those older than 40 only
2 stages
- Identify those at risk + offer monitoring
- Offer 24hr ambulatory BP monitoring (ABPM)
Results are shared with GP
What is a low clinic BP?
≤90/60mmHg
What is a normal clinic BP?
90/60mmHg to <140/90mmHg
What is a high clinic BP?
140/90mmHg to <180/120mmHg
What is a very high clinic BP?
≥180/120mmHg
What is the ‘Stop Smoking Advanced Service’?
From Jan 2022 onwards
NHS Trusts can refer patients discharged from hospital to a community pharmacy of their choice
To continue smoking cessation pathway
What is the ‘Hepatitis C Testing’ service?
Community Pharmacy Hepatitis C Antibody Testing Service
Provision of point of care testing (POCT) for HepC antibodies to people who inject drugs (PWIDs)
What is POCT?
Point of care testing
What are PWIDs?
People who inject drugs
Who is eligible for Hep C Testing Service?
(1) >18yrs old
(2) Not engaged in community drug and alcohol treatment services
How can consent be gained for the Hep C Testing Service?
Verbally
What is NMS?
New medicines service
Cap is increasing from 0.5 to 1% by contractors
What conditions are eligible for NMS?
(1) Asthma/ COPD
(2) T2DM
(3) HTN
(4) Hypercholesterolaemia
(5) Osteoporosis
(6) Gout
(7) Glaucoma
(8) Epilepsy
(9) Parkinsons
(10) Urinary incontinence/ retention
(11) Heart failure
(12) Acute coronary syndromes
(13) AFib
(14) Long-term VTE risk
(15) Stroke/ TIA
(16) CHD
How many conditions are eligible for NMS?
16
What is the ‘Community Pharmacy Consultation Service’?
Pharmacies take referrals from 111 calls
General practice for minor illness + urgent medicines supply
What should you do if contacted by a patient for the Community Pharmacy Consultation Service, but there is not referral on the system?
(1) Check patient is at correct pharmacy
(2) Check NHS mail
(3) Contact NHS 111 provider’s HCP or GP (whoever sent referral)
(4) Confirm patient’s NHS number/ ask for referral to be resent
(5) If no referral, treat patient as normal
What are government ‘emergency powers’?
Ability to respond rapidly to a public emergency
Enacting new/ existing legislation
Are prescriptions from EEA or Switzerland still approved following Brexit?
Rx must originate from a country or prescriber on the approved list
What are the prescription requirements from an approved healthcare professional?
(1) Patient details
(2) Prescriber details
(3) Prescribed medicine details
(4) Prescriber signature
(5) Date of issue
- 6 months
- 28 days for Sch 4 CDs
Is a prescription written in a foreign language valid in the UK?
Yes
Provided that it meets the appropriate prescription requirements
What is the prescription charge waiver?
Antiviral medicines to be supplied free of charge to COVID + patients who are considered eligible
Until 31st March 2022
What is the ‘Medicines and Medical Devices Act 2021’?
New act to provide powers to amend current acts and regulations, such as:
- Human medicines regulations
- Veterinary medicines regulations
- Medical devices regulations
What are the core values of the patient safety commissioner?
(1) Promote safety of patients with regard to the use of medicines and medical devices
(2) Promote importance of views of the patients and other members of the public to the safety of medicines and medical devices
What is hub and spoke dispensing?
A hub takes in prescriptions from many retail pharmacies (spokes)
Spoke checks and dispenses the medicine to the patient
What are Caldicott Guardians?
Senior figure within health/ social care
Ensure those using the service have their personal information treated appropriately, legally, and ethically
When are Caldicott Guardians required?
Every NHS organisation/ local authority with adult social care responsibilities
When can a Caldicott Guardian serve multiple organisations?
When is it not proportional for one Caldicott Guardian to serve one organisation
e.g. several smaller ones
Who can access summary care records (SCRs) in the pharmacy?
Pharmacists/ pharmacy technicians
Which pharmacies do not require a consultation room?
Small pharmacies + distance selling pharmacies (DSPs)
What are the stages of the veterinary cascade?
(1) Supply a vet med for the species + condition indicated
- if not possible, vet med with NI approval for species + condition indicated
(2) If not possible a GB/ NI/ UK wide licensed for another species/ condition
(3) If not possible a GB/ NI/ UK licensed for humans or vet med licensed outside of the UK
(4) Where not possible, an extemporaneous/ specially manufactured medicine can be considered
What is the Botulinum Toxin and Cosmetic Fillers Children Act 2021?
Criminal offence to administer botulinum toxin/ filler by way of injection for cosmetic purposes to a person <18yrs
Criminal offence to make arrangements to provide cosmetic botulinum toxin/ filler to a person <18yrs
What is the fine for failing to comply with the Botulinum Toxin and Cosmetic Fillers Children Act 2021?
Unlimited fine
When approved by a GP, which HCPs can administer botulinum toxin to a patient <18yrs?
Pharmacist/ nurse/ dentist
What is the CPCF?
The Community Pharmacy Contractual Framework
Name some advanced services potentially offered in pharmacies?
(1) Appliance use review
(2) Stoma appliance customisation
(3) New medicines service (NMS)
(4) Flu vaccination service
(5) Community pharmacist consultation service
(6) Hepatitis C testing
(7) C-19 lateral flow test distribution
(8) HTN case finding service
(9) Stop smoking advanced service
What is ‘pharmacy collect’?
C-19 lateral flow test kit distribution
How many C-19 test kits can be sold in one transaction?
2, one each for a maximum of 2 individuals
What is the Hypertension Case-Finding Service?
(1) Identifying people with potential for high BP and offering them clinic checks
(2) Offering 24hr ambulatory BP monitoring (APBM), when clinically indicated
Which patient group is the Hypertension Case-Finding service directed at?
> 40 years old
No previous diagnosis
Which patient group can be included in the Hypertension Case-Finding Service, at the pharmacist’s discretion?
<40yrs old
What is the ‘Stop Smoking Advanced Service’?
Referral of discharged hospital patients to a community pharmacy of their choice, for medication and behavioural support
Who is eligible for the ‘Stop Smoking Advanced Service’?
Only patients who have been referred during their discharge from an acute NHS trust
What does the term ‘PWID’ refer to?
Patients Who Inject Drugs
What is the target group for pharmacy Hepatitis C Testing?
PWIDs >18yrs
Not engaged in community alcohol/ smoking cessation services
What consent is required prior to administering Hepatitis C Testing in a pharmacy?
Verbal consent
What is the process, following Hepatitis C Testing, if a patient is positive for antibodies?
Referred for confirmatory test + treatment
What is the limit on the number of NMS a pharmacy can currently run?
Currently 0.5% but is being increased to 1% of monthly prescription volume
Name some conditions eligible for NMS?
- Asthma/ COPD
- T2DM
- HTN
- Hypercholesterolaemia
- Osteoporosis
- Gout
- Glaucoma
- Epilepsy
- Parkinson’s
- Urinary incontinence/ retention
- Heart failure
- Acute coronary syndromes
- AFib
- Long term risk of VTE
- Stroke/ TIA
- CHD
What is the CPCS?
Community Pharmacy Consultation Service
Pharmacies take referrals from NHS 111
What process should be followed if there is no evidence of referral on CPCS IT system but a patient has approached you?
(1) Confirm patient is at correct pharmacy
(2) Check NHS mail
(3) Contact NHS referral source
- confirm patient’s NHS number + GP
(4) Ask to be resent the referral
What should be done if a patient approaches from the CPCS system and you have already checked and confirmed no referral is present?
Deal with the patient as you usually would outside the CPCS system
How can CPCS consultations be held?
Ideally in person
Telephone consultation since C-19
What type of consent is required for NMS/ Flu vaccination service/ Appliance Use Reviews (AUR)?
Verbal consent – since 1st Sept 2020
What is the Pandemic Treatment PGD?
Supply of POM for prevention/ treatment of disease that is anticipated to be imminently pandemic
What are serious shortage protocols (SSPs)?
Endorsement code SSP for any supplies made in accordance with SSP regulation
What are some oral retinoids that should be avoided in pregnancy (PPP)?
- Oral isotretinoin
- Oral acitretin
- Oral alitretinoin
What is the referral criteria for a female patient on oral isotretinoin, with regard to PPP?
Female patient has become pregnant within 1 month of stopping isotretinoin
How long are prescriptions for oral retinoids valid?
7 days
What is the quantity limit for prescribing oral retinoids?
30 days supply
What is essential to be checked before prescribing oral retinoids to a female patient?
Negative pregnancy test
What should be provided, alongside valproate, when dispensed to all female patients?
Provide a valproate patient card
What does the prescriber endorsement ‘FS’ mean?
Free supply of sexual health treatment
Who can apply the ‘FS’ endorsement on a prescription?
Prescriber only
What are the 7 requirements of a prescription for it to be considered legally valid?
(1) Name of patient
(2) Age of patient (DOB) (if under 12yrs old)
(3) Address of patient
(4) Prescriber signature
(5) Prescriber work address
(6) Date prescription was written
(7) Particulars of prescriber
- prescriber type + role, e.g. ‘Dr’
What ink are prescriptions required to be written in?
Indelible ink
What type of prescription are repeat prescriptions normally written on?
Private prescriptions
How many times can a repeat prescription be dispensed if a number is not specified?
2 times
What is the maximum number of times a repeat prescription can be dispensed if the number is specified?
5 times
(1) Which controlled drug schedules can be repeated?
(2) Which can not?
(1) CD4 and CD5 -> CAN
(2) CD2 and CD3 -> CANNOT
For a repeat prescription, which controlled drug schedule(s) must the prescription be dispensed within 28 days?
CD4
CD5 is 6 months
What is the time limit of remaining repeats on a controlled drug repeat prescription, following dispensing within 28 days?
No time limit, provided that first one is dispensed within 28 days (CD4)
How long must private prescriptions of a POM be kept?
2 years from the date of sale/ supply
2 years of last supply for repeats
What details are required on the POM register?
(1) Supply date
(2) Prescription date
(3) Medicine details
(4) Prescriber details
- name
- address
(5) Patient details
- name
- address
Which POM prescriptions are exempt from a POM register?
(1) CD2, as a CD register must be completed
(2) Oral contraceptives
Can an EEA/ Swiss prescriber request emergency supply?
Yes, if prescription provided within 72 hours
NOT CD1/2/3, including phenobarbital
Can an EEA/ Swiss prescriber prescribe controlled drugs with emergency supply?
Yes, CD4 and CD5 only
NOT CD1/2/3
What is a PGD?
A written group direction that allows the supply/ administration of a specified medicine(s)
Which CDs cannot be dispensed via emergency supply at the request of a prescriber?
CD1, CD2, CD3
Exception of phenobarbital (UK prescriber only)
What record must be made for emergency supply at request of a prescriber?
POM Register, unless CD1/ CD2
What details are required on the appropriate register (records) kept for emergency supply at the request of a prescriber?
POM Register
(1) Date POM was supplied
(2) Name, strength, form, quantity of medicine supplied
(3) Name + address of prescriber
(4) Name + address of patient
(5) Date on prescription
- added when Rx received by pharmacy
(6) Date on which prescription was received
- added when Rx received by pharmacy
What needs to be identified to supply at emergency request of a patient?
(1) Interview
(2) Identify immediate need
(3) POM requested must have been previously prescribed by a UK/ Swiss/ EEA prescriber
(4) Pharmacist must be satisfied with the dose the patient wishes to take
What is the maximum duration of treatment for a controlled drug supply at the emergency request of a patient?
Phenobarbital, CD4 or CD5 - 5 days
No more than 30 days for every other POM
For supply at emergency request of patient for items such as inhalers, ointments (where the pack cannot be broken) how much should be supplied?
The smallest available pack size
For supply of an oral contraceptive at the emergency request of a patient, how much should be supplied?
Full treatment cycle
What records must be kept following emergency supply at the request of a patient?
POM Register
What is the difference between the records kept for emergency supply at the request of a prescriber and that of a patient?
Patient POM record includes reasons for emergency supply necessity, e.g. why Rx cannot be obtained
Prescriber POM record includes date on Rx and date Rx received
Which levonorgestrel brand, specifically, is a P-med contraceptive?
Levonelle OneStep 1.5mg
What is the Gosport Report?
1988-2000 around 450 patients expected to have died from inappropriately high opiate doses
Report produced to prevent reoccurrence
What is an ‘accountable officer’?
Responsible for supervising and managing the use of CDs
(1) Which CD category is split into 2 parts?
(2) What are these 2 parts?
(1) CD4
(2)
- Benzodiazepines
- Anabolic + androgenic steroids
Which CDs are valid for 28 days and which are valid for 6 months, if any?
- CD2-4 = 28 days
- CD5 = 6 months
Which CDs are required to have been prescribed by a prescriber in the UK?
CD2 + CD3
Which CDs can Swiss/ EEA prescribers legally prescribe?
CD4 + CD5
Which CD prescriptions are repeatable?
CD4 + CD5
For which CD schedules are invoices required to be retained for 2 years?
CD3 + CD5
What are the prescription requirements for CD2 and CD3?
(1) Patient name
(2) Patient address
(3) Patient age (if under 12)
(4) Quantity (words + numbers)
(5) Dose
(6) Form
(7) Strength
(8) Prescriber signature
(9) Prescriber role
(10) Prescriber’s address
(11) Date prescribed
(12) Prescriber identification number
What does ‘NFA’ on a prescription stand for?
No fixed abode
What is the recommendation for prescribing sugar-free products?
Higher potential for abuse
RPS recommends only to supply if specifically prescribed
What is the standardised controlled drugs private prescription form?
FP10PCD
What is an FP10PCD form used for?
Standardised controlled drugs private prescription form
If a HCP acting in their professional capacity comes to collect a dispensed CD2 prescription on behalf of a patient, what must the pharmacist confirm?
(1) Name of HCP
(2) Address of HCP
(3) Request ID
Which controlled drugs must be kept under safe custody?
- CD1
- CD2 (except some liquid formulations)
- CD3 (unless exempt, e.g. tramadol/ phenobarbital)
What are the requirements for controlled drug disposal within the pharmacy?
Responsible for denaturing of drugs
CD2/3/4part1
When is a CD Register required for disposal of controlled drugs?
Expired/ obsolete/ unwanted stock
- CD2s only
How are controlled drugs denatured when disposed of in the pharmacy?
Incinerated
How are solid dosage forms disposed of in the pharmacy?
Grind/ crush before adding CD denaturing kit
How are liquid dosage forms disposed of in the pharmacy?
Pour into an appropriately sized denaturing kit
When are CD Registers legally required?
CD1 or CD2
What details are required on a CD Register for CDs received?
(1) Date supply received
(2) Name + address from whom received
(3) Quantity received
What details are required on a CD Register for CDs supplied?
(1) Date supplied
(2) Name + address of recipient
(3) Details of authority to possess
What categories of veterinary prescriptions are there?
(1) POM-V
(2) POM-VPS
(3) NFA-VPS
(4) AVM-GSL
What is a POM-V prescription?
POMs prescribed by a veterinary surgeon
Supplied by either a veterinary surgeon/ pharmacist with a written prescription
What is a POM-VPS prescription?
POMs prescribed by a veterinary surgeon/ pharmacist/ suitably qualified person (SQP)
Oral/ written
- written required when supplier is not prescriber
When is a written prescription required for POM-VPS?
When supplier is not the prescriber
What is an NFA-VPS prescription?
Category of medicine for non-food animals
Supplied by veterinary surgeon/ pharmacist/ suitably qualified person (SQP)
Written prescription not required
What type of prescription is required for an NFA-VPS prescription?
Not a written prescription
Oral is sufficient
What is an AVM-GSL prescription?
For a veterinary medicine that is available on general sale
What are the prescription requirements for POM-V, POM-VPS, and medicines supplied under the veterinary cascade?
(1) Name/ address/ telephone/ qualification/ signature of prescriber
- RCVS reg num. required for CD2 + CD3
(2) Name + address of owner
(3) Identification + species of animal
(4) Valid for 6 months
- 28 days for CD2/3/4
(5) Name/ quantity/ dose/ administration instructions
(6) Necessary warnings
(7) When/ if medicine is prescribed under the veterinary cascade
(8) ‘Prescribed for animal/ herd under prescriber’s care’ if CD2 or CD3
(9) If repeatable, how many times it can be repeated
Are full words and figures required for CDs on a veterinary prescription?
Yes
Are standardised forms required for veterinary medicines on veterinary prescriptions?
No
How long should veterinary prescriptions be retained for?
5 years
NOT submitted to relevant NHS agency
What is the purpose of the veterinary medicine cascade?
To prescribe and supply medicines that are unlicensed for animals
- when specified ‘for administration under cascade’
When licensed medicines are not appropriate
What are the stages of the veterinary cascade?
(1) Supply a licensed vet med where available
(2) An existing licensed vet med for another animal/ condition should be prescribed
(3) Licensed human medicine
(4) Extemporaneous/ specially-manufactured medicines can be considered
What are the labelling requirements for supply of a veterinary medicine?
(1) Name of prescriber
(2) Name + address of owner
(3) Name + address of pharmacy
(4) Identification + species of animal
(5) Date of supply
(6) Expiry date
(7) Words ‘For animal treatment only’
(8) Words ‘Keep out of reach of children’
What are the 9 standards for pharmacy professionals?
(1) Provide person-centred care
(2) Work in partnership with others
(3) Communicate effectively
(4) Maintain, develop + use professional knowledge and skills
(5) Use professional judgement
(6) Behave in a professional manner
(7) Respect + maintain person’s confidentiality
(8) Speak up when having concerns/ things go wrong
(9) Demonstrate leadership
On an FP10-MDA prescription how many days have to be missed before no further supply can be made?
3 days missed
In England, what can be prescribed on an FP10-MDA prescription?
- CD2
- Buprenorphine
- Buprenorphine/ naloxone (Suboxone)
- Diazepam
What is the maximum duration of treatment that can be supplied from an FP10-MDA prescription form?
14 days
What endorsement should be made by the supplier of an FP10-MDA prescription?
Endorse volume/ quantity given