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