Pharmacy Law 2
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- Created by: LBCW0502
- Created on: 13-10-17 22:04
What are the three categories of medicines?
General Sales List (GSL), Pharmacy (P), Prescription Only Medicines (POM)
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How can GSL medicines be sold?
Without supervision of pharmacist, in any retail premises which can be closed to exclude public, automated dispensing machines and in original packs
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How can P medicines be sold?
Only in registered pharmacies and by/or under the supervision of a pharmacist
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When does a pharmacist not have to be involved in the sale of a P medicine?
On the premises (able to intervene), sales by trained staff working to protocols, must not be accessible to public by self-selection
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Who can supply POMs against a prescription? (6)
Medical practitioner (doctor), dentist, IP, SP, community practitioner nurse (limited POMs), EEA Swiss doctors/dentists (but not for all CDs)
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What are the conditions for POM? (2)
All new medicines are POM for the first five years of licensing, all parenteral (injection) medicines are POM, including sterile water for injection
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How can POMs become GSL or P? (3)
Reduce pack size, reduce strength, reduce maximum dose
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What are the other POM exemptions? (4)
Low concentrations of CDs, emergency supply, patient group direction and written direction (hospital practice)
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What are the prescription requirements? (3)
Signed by prescriber (advanced electronic signature), indelible, dispensed in appropriate time (6 months)
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What details must a prescription include? (5)
Address of prescriber (indication of an appropriate practitioner), date, age of patient/DOB for under 12s, name and address of patient
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The regulations for dispensing European prescriptions covers who?
EU nations (EEA), Norway, Iceland, Lichtenstein, Swtizerland
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What do these regulations for European prescriptions allow? (3)
Dispensing of prescriptions, emergency supply at direction of prescriber, emergency supply at request of patient
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How can a medicine for a patient be provided? (3)
NHS, insurance, self pay
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Which details are not part of the prescription requirement?
Details of the medicine such as dosage and form (this comes under 'clinical' screening)
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For an NHS prescription, are records required?
No
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Which details are required for a private prescription? (5)
Date of prescription/supply, patient/prescriber details, details of medicine supplied, reference number/price, prescription kept for 2 years (keep record for 2 years after last entry)
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Which medications can doctors (medical practitioners) prescribe?
Legally, any medicine (including CDs). Under NHS, any that are not 'black-listed' in BNF
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Which medications can dentists prescribe?
Legally, any medicine (including CDs) Under NHS, in the Dental Practitioners Formulary (DPF)
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What are the procedures for a supplementary prescriber? (4)
Training course, annotated register, partnership (patient/doctor/SP), clinical management plan
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The procedures for a supplementary prescriber includes who? (7)
Nurses, midwives, pharmacists, podiatrists, physiotherapists, radiographers and optometrists
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What are the procedures for an independent prescriber? (3)
Training course, annotated register, 'whole BNF'
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The procedures for a supplementary prescriber includes who? (7)
Nurses, pharmacists, optometrists, physiotherapist, veterinary surgeon and practitioner
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What are the issues with BNF for IP? (3)
Limited area of competence, unlicensed medicines are allowed subject to good clinical practice and CDs are allowed if within area of competence
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Which medications can a community practitioner nurse prescribe? (3)
Very early form of non-medical prescribing, district nurses and health volunteers, very limited range of medicines in the Nurse's Prescribing Formulary
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What is a patient group direction?
A written instruction for the sale, supply and/or administration of named medicines in an identified clinical situation
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Who does the patient group direction apply to? (2)
Groups of patients who may not be individually identified before presenting for treatment. See and treat/minor injury units
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What is the procedure for patient group direction? (3)
Produced by multi-disciplinary team, authorised for use within specific organisation and signed by doctor/dentist/pharmacist/organisation representative
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What are the details in a patient group direction? (7)
Details of organisation, clinical indication, medicine to be used, label, warnings (adverse reaction), appropriate patients/exclusion criteria and review date/training requirements/audit
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Which professions take part in patient group direction?
Lots, as for SP and dietician, occupational therapists and many more
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What types of medicines are involved in patient group direction? (3)
Analgesics, emergency contraception, vaccines (flu campaigns)
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In an emergency can POMs be supplied from a pharmacy without a prescription?
Yes (two scenarios - request of patient, request of prescriber (doctor, dentist, SP, IP)
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Emergency supply excludes CDs in Schedule 2 and 3 except for what?
Epilepsy (phenobarbitone)
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Is emergency supply an NHS service?
No
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What are the key aspects of a patient request? (5)
Interview patient, immediate need, getting a prescription on undue delay, patient has had medicine before, patient knows the dose
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What is the maximum supply (patient request)?
Maximum 30 day supply
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What are the exemptions for the maximum supply (patient request)?
Pack should not/cannot be broken, maximum 5 days for Schedule 4 or 5 CD
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Entry must be made in which register?
Entry in POM register (as for private prescription plus reason for emergency supply)
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What details are included in the label for medicine (patient request)? (4)
Date of supply, name/strength/quantity, name/address of patient/pharmacy and 'emergency supply'
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What are the aspects of a prescriber request? (5)
Request must be genuine from prescriber (unsatisfied/prescription cannot be provided), prescription within 72 hours, record in prescription register (+ date on which prescription was actually received), label, no limit on quantity
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Why is self prescribing considered to be poor practice? (3)
Professional judgement may be impaired or influenced, may not be possible for proper clinical assessment, GMC and NMC advice is to avoid self prescribing
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What are unlicensed medicines (1)?
Off label. Medicines has Market Authorisation but it is being used outside that: clinical indication, dose, route or patient group (e.g. children)
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What are unlicensed medicines (2)?
No MA in the UK, imported, special (manufacturer's licence, medicines act exemption), not a medicinal product - diagnostics or devices often fit this category
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What does Part 10 of the Human Medicines Regulations state? (3)
Allows doctor/dentist to prescribe or order, allows pharmacist to prepare or order to meet the prescription, allows a medicine ordered and supplied under the above to administered
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Professional exemption is under with part of the Human Medicines Regulations?
Part 12
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Which medicines can doctors/dentists sell/supply to their own patients?
All medicines
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Which medicines can midwives sell/supply in course of practice?
Any GSL or P medicine, a few POMs (administer certain specified POMs by injection)
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Which medicines can optometrists sell/supply in course of practice?
Any GSL or P medicines and a few POMs. Can obtain for use in practice (no sell/supply) certain local anaesthetics
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Which medicines can podiatrists (registered chiropodists) sell/supply in course of practice?
Any GSL or P medicines and a few POMs. With additional qualifications, can administer some POMs by injection
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Registered ambulance paramedics can administer which types of medication?
Certain specified POMs by injection for immediate necessary treatment of a sick of injured person
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Which professional may supply any medicines as necessary for sick and injured people?
Certified first aiders of recognised first aid organisations (Red Cross, RNLI)
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What are the professional exemptions for owners and masters of ships which do not carry a doctor?
Drug treatment services for addicts can supply ampoules up to 2 mL sterile water for injection (POM) - others e.g. occupational health schemes, seek advice if unsure
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Pharmacists working in registered pharmacies are exempt from licensing for which professional functions? (5)
Dispensing against a prescription, preparing to a formula (P or GSL), counter prescribing (OTC), assembly, sales to practitioners
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What are the aspects of licensing exemption? (5)
No MA for import for personal or family use, no MA required where made for export only, vitamin supplement provided no medicinal claims, clinical trials still requires a certificate from MHRA
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Other cards in this set
Card 2
Front
How can GSL medicines be sold?
Back
Without supervision of pharmacist, in any retail premises which can be closed to exclude public, automated dispensing machines and in original packs
Card 3
Front
How can P medicines be sold?
Back
Card 4
Front
When does a pharmacist not have to be involved in the sale of a P medicine?
Back
Card 5
Front
Who can supply POMs against a prescription? (6)
Back
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