U1 L1 & L2 Sale And Supply Flashcards

1
Q

When was the Responsible Pharmacist introduced?

A

2008

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2
Q

What is the main responsibility of the RP?

A

To ensure the safe and effective running of the pharmacy

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3
Q

What must be included on the RP notice?

A

Name and registration

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4
Q

What is included in a pharmacy record?

A
  • Name
  • Date
  • GPhC number
  • Time signs in and out
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5
Q

How long must a pharmacy record be kept?

A

5 years after the last entry or forever if electronic

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6
Q

Under what circumstances is a pharmacy able to run without an RP present?

A
  • RP is contactable
  • Pharmacy runs safe and effectively without RP
  • RP able to return quickly
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7
Q

How long can an RP be absent in a given 24 hours?

A

2 hours

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8
Q

What are other members of staff able to do while the RP is absent?

A
  • assemble medications if competent
  • sell GSL meds
  • take prescriptions with permission from RP
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9
Q

Without the presence of a second pharmacist, staff cannot …

A
  • sell P meds
  • hand out prescriptions
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10
Q

What is the Human Medicines Regulation of 2012?

A

Regulation stopping sale of ineffective or dangerous drug formulations

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11
Q

How does the Human Medicines Regulation define ‘medicinal product’?

A

Any substance or combination of substances presented as having properties of preventing or treating disease in human beings

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12
Q

What are marketing authorisations? (product licenses)

A

Allow for manufacture and sale of medicinal products
(Having ensured the product has met standards for safety, quality, efficacy)

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13
Q

Where are marketing authorisations obtained from?

A

MHRA - Medicines and Healthcare Regulatory Agency

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14
Q

What is meant by ‘off label’ medicines?

A

Medicines that can be used outside the terms of the MA e.g. aspirin

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15
Q

When is it acceptable to use unlicensed medications in the UK?

A
  • licensed from outside the EU
  • unlicensed but manufactured in UK
  • non-medicines e.g. supplements
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16
Q

What are the characteristics of GSL meds?

A
  • short term and generally safer
  • no need for pharmacist present
  • label does not need GSL
  • must be sold in original, unopened containers
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17
Q

What are the characteristics of P meds?

A
  • supplied from registered pharmacy under pharmacist supervision
  • must contain P in box on packaging
  • must not be available for self selection by public
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18
Q

What are the characteristics of POM?

A
  • 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
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19
Q

Under what circumstances can POM be given without prescription?

A
  • emergency supply (in advance of prescription)
  • patient group directions e.g. prescribers giving morning after pill
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20
Q

POMV

A

Prescription only medicines for veterinary

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21
Q

AVM-GSL

A

Authorised vet medicine general sales list

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22
Q

pack size Paracetamol and 325mg Aspirin as GSL

A

Max pack size 16

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23
Q

pack size Paracetamol and 325mg Aspirin as P

A

Max pack size 32

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24
Q

pack size Paracetamol and 325mg Aspirin as POM

A

Anything over 100

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25
Q

pack size 75mg Aspirin as GSL

A

Max pack size 28

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26
Q

What two active ingredients cannot be sold together?

A

Pseudoephedrine and ephedrine

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27
Q

Ephedrine for P

A

180mg max

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28
Q

Pseudoephedrine for P

A

720mg max

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29
Q

Co-codamol as P pack size

A

Max pack size 32

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30
Q

What are the five legal requirements for an NHS or private Rx?

A
  1. Patient name and address
  2. Age or date of birth (both if under 12)
  3. Prescriber signature
  4. Date within 6 months
  5. Prescriber details
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31
Q

What is included in the prescriber details on a Rx?

A
  • name
  • registration number
  • address
  • contact details
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32
Q

What legal errors on a Rx can a pharmacy amend?

A

Name, address, age or d.o.b.

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33
Q

What is needed to be considered sufficient information with regard to a medicine on a prescription?

A
  • strength
  • quantity
  • dose
  • dose frequency
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34
Q

What must be included on the POM register?

A
  • patient name and address
  • prescriber name and address
  • medication prescribed name, quantity, strength, form
  • date on Rx
  • reference number
  • date of dispensing
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35
Q

What must dispensing labels contain?

A
  • 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
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36
Q

What is EPS?

A

Electronic prescription service

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37
Q

How does EPS work for repeat prescriptions?

A

Sends Rx from GP to patient choice of pharmacy

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38
Q

How does EPS benefit patients?

A
  • 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
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39
Q

How does EPS benefit pharmacies and the NHS?

A
  • saves time, storage and money
  • Rxs cannot get lost between GP and pharmacy
  • improved stock control; eRD downloaded 7 days early therefore prep time
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40
Q

What does eRD stand for?

A

Electronic repeat dispensing

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41
Q

What is meant by ‘acute’ prescription?

A

Medicine issued by GP but not added to repeat Rx record

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42
Q

What Rx can be EPS?

A

Acute or repeat Rx in primary or secondary care

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43
Q

What cannot be prescribed under EPS?

A
  • schedule 1 controlled drugs
  • medicines outside of NHS Dictionary of Medicines and Devices (dm+d)
  • private prescriptions
  • items for personal admin
  • instalment prescribing (FP10MDA)
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44
Q

What is a post-dated Rx?

A

A Rx written to be filled at a later date

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45
Q

What happens to post-dated Rxs in the EPS?

A

Post-dated Rxs are held locally within the system and automatically sent to the pharmacy system on the specified date

46
Q

the content of a post-dated Rx on the EPS cannot be viewed by the pharmacy prior to the specified date meaning…

A
  • information regarding the Rx cannot be checked by the pharmacy prior to the date
  • the Rx cannot be prepared in advance
47
Q

An alternative use of post-dated EPS Rxs may be

A

The eRD

48
Q

What controlled drugs can be given via EPS?

A

Schedule 2 and 3

49
Q

What is different about prescribing oral liquid methadone as EPS?

A

A paper FP10 Rx needs generating so that the pharmacy can collect the correct fees

50
Q

What are some uses of controlled drugs?

A
  • pain relief
  • palliative care
  • epilepsy
  • alcohol and drug withdrawal
  • methadone substitution
51
Q

What are the five classes of controlled drugs?

A
  • 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
52
Q

Safe custody requirements for all schedule 2 CDs except

A

Quinalbarbitone

53
Q

Schedule 1,2,3, and 4 Rxs are valid for how long?

A

28 days

54
Q

Records of supply of Schedule 2 CDs must be kept in the

A

Controlled drugs register

55
Q

Schedule 5 Rxs valid for

A

6 months

56
Q

Emergency supply of Schedule 1,2 or 3 cannot be made except for

A

Phenobarbitone for treatment of epilepsy

57
Q

A veterinary medicine is defined as any substance …

A

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

58
Q

POM-V characteristics

A
  • only prescribed by a veterinary surgeon
  • supplied by a veterinary surgeon or pharmacist with written Rx
  • clinical assessment of animal by vet required
59
Q

POM-VPS meaning and characteristic

A

POM that can be prescribed and supplied by a vet surgeon, pharmacist or suitably qualified person upon oral or written Rx

60
Q

When is a written Rx needed for POM-VPS?

A

If the supplier is not the prescriber

61
Q

NFA-VPS characteristic

A

Medicine for non-food animals

Can be supplied by vet surgeon, pharmacist or suitably qualified person

Written Rx not required

62
Q

AVM-GSL characteristic

A

An authorised veterinary medicine that is available on general sale

63
Q

A pharmacist prescribing/supplying POM-VPS or NFA-VPS must

A
  • 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
64
Q

What is The Cascade Exemption?

A

Allows for supply of human medicines not otherwise licensed for use in animals

65
Q

Under what circumstance can a human medicine lawfully be supplied against a Veterinary Rx?

A
  • if it is prescribed by a Vet
  • Rx specifically states ‘for administration under the Cascade” or wording to this effect
66
Q

What are the stages of the Cascade?

A
  1. When not possible to supply a licensed vet med, consider existing vet med for another species/condition
  2. When above not possible an EU or UK licensed human med can be considered
  3. When above not possible, extemporaneous or specially manufactured med can be considered
67
Q

What are the three types of Rx collection and/or delivery service?

A
  • Standard Prescription Collection Service
  • Managed Prescription Collection Service
  • Delivery Service

All governed by GPhC

68
Q

How does the Standard Prescription Collection Service work?

A

Pharmacy receives Rx from someone other than the patient or their representative

E.g. is collected by driver/pharmacy staff

69
Q

Under the Standard Prescription Collection Service, what four things must the pharmacy do?

(This is the same for MPCS)

A
  1. Obtain consent to receive patient Rxs
  2. Explain to patient/carer what service involves, when to collect Rxs
  3. Ensure Rxs collected by persons in accordance with pharmacist’s directions
  4. Have procedures to safeguard confidentiality and security
70
Q

What are three rules regarding the process of the Standard Prescription Collection Service?

A
  1. Request for ongoing service must be direct from patient or carer (ideally in writing)
  2. On receipt of Rx the pharmacist must ensure they are authorised to receive and dispense
  3. Any Rx received without consent to be returned to GP
71
Q

How does the Managed Prescription Collection Service differ from the Standard Prescription Collection Service?

A

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

72
Q

How does using Managed Prescription Collection Services benefit the pharmacy?

A
  • allows 7 days to order and dispense Rx
  • reduces wastage
  • increases compliance
  • secures a patient’s repeat custom
73
Q

How do Prescription Delivery Services work?

A

Medicines are handed to the patient/carer someplace other than the registered pharmacy premises e.g. their home

74
Q

What are three considerations to ensure best practice for Prescription Delivery Services?

A
  1. Pharmacist has responsibility to ensure patient knows how to safely use meds, have no side effects or compliance issues
  2. Pharmacist must obtain consent to receive and dispense, preferably in writing
  3. Appropriate records must be kept
75
Q

For what types of drugs must the pharmacist exercise caution supplying via Prescription Delivery Services?

A

Drugs requiring frequent blood level monitoring e.g. warfarin

76
Q

What are some responsibilities of the pharmacist regarding Prescription Delivery Services?

A
  • 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
77
Q

What forms are involved in Batch Repeat Dispensing, RPD?

A
  1. Repeat Dispensing Rx - authorising Rx (for 2.) - marked ‘RA’
  2. Repeat Dispensing issue forms - marked ‘RD’
78
Q

How long are RD issue forms valid for?

A

Up to 12 months

79
Q

What does patient supply to chosen pharmacy to begin BRD?

A

Both the authorising repeat dispensing Rx and first RD issue form

80
Q

Who keeps the remaining RD issue forms?

A

The patient or the pharmacy

81
Q

What happens when the patient uses the last RD issue form?

A

The pharmacy will prompt the patient to revisit the GP for a new set of RP forms along with a new RA Rx

82
Q

What if the patient already has a sufficient supply of a medication on the RD?

A

The pharmacy does not have to supply every med on the form with each RD issue

83
Q

What type of patient is best suited to BRD?

A

Patients on a stable long-term treatment e.g. those with a chronic illness

84
Q

What are the benefits of BRD to the patient?

A
  • 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
85
Q

What is the the benefit of BRD to the pharmacy?

A

Reduced workload

86
Q

Why are faxed Rxs risky?

A
  • not legally valid because not indelible ink, not signed by appropriate practitioner
  • associated with misinterpretation, fraud etc
87
Q

When may faxed prescriptions occur?

A

Emergency supply

88
Q

Should a faxed prescription be used, what must be done?

A
  1. Ensure integrity of original Rx e.g. phone surgery
  2. Make arrangements to get original Rx ASAP
89
Q

Supply of what drugs without possession of a lawful Rx could be prosecuted as a criminal offence?

A

Schedule 2 or 3 Controlled Drugs

90
Q

Most medicine wholesalers are required to have what sort of licence according to the MHRA?

A

Wholesale Dealer’s License - WDA(H)

91
Q

In order for pharmacies to remain exempt from needing a Wholesale Dealer’s License when supplying to other HC professionals, what is required?

A
  • supply must take place on occasional basis
  • small quantities supplied
  • supply on a not for profit basis
  • supply not for onward wholesale distribution
92
Q

For what three instances do pharmacies not require a Wholesale Dealer’s License?

A
  1. To supply meds to UK public and others authorised to receive meds
  2. To obtain small quantities of meds from another pharmacist to meet needs of individual patient
  3. To supply meds to other UK HC providers who hold meds for treatment and supply
93
Q

What is a Signed Order?

A

A document needed to allow a registered pharmacy to supply POMs to HC professionals

94
Q

When a pharmacy supplies POM to another HC professional what must be done?

A

An entry must be made to the POM register
OR
The Signed Order/invoice must be retained for 2 years from date of supply

95
Q

What must be included in the POM register entry if medicine supplied to a HC professional?

A
  • 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
96
Q

What six other circumstances allow the sale or supply of POMs without a prescription?

A
  1. Emergency injections
  2. Pandemic exemptions
  3. Optometrist/podiatrist signed orders for patients
  4. Supply of Salbutamol inhalers to schools
  5. Supply of adrenaline autoinjectors to schools
  6. Supply of naloxone to individuals providing recognised drug treatment services
97
Q

What is meant by ‘repeatable’ Rx?

A

The instance where a prescriber adds an instruction for the prescribed item to be repeated ie. Supplied more than once against the same form

98
Q

What schedules of Controlled Drugs are repeatable for private Rxs?

A

Schedules 4 and 5

(Not 2 or 3)

99
Q

Within how many days must schedule 4 Controlled Drugs be dispensed for Private Scripts?

A

28

100
Q

For most private repeatable Rx (including Schedule 5 CDs), within how long must the first dispensing be made?

A

6 months

101
Q

What is the legal time limit for the remaining repeats after the first dispensing of a repeatable private Rx?

A

There is no legal time limit

102
Q

How many total times would a medicine be dispensed if Rx repeated 5x?

A

6 total dispenses

103
Q

How many times can a repeatable Rx be dispensed if number of repeats is not stated?

A

Once

104
Q

What is the exception regarding only repeating the dispense of a repeatable Rx once if the number of repeats is not stated?

A

Oral contraception, one month supply

Can be dispensed 6 times (repeated x5) within 6 months of appropriate date

105
Q

How is an audit trail of a repeatable Rx maintained?

A

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

106
Q

How are records of NHS Rxs kept in Wales?

A

PMR - Patient Medication Record

Rx sent to NHS Wales Shared Services Partnership (NWSSP) at end of month

107
Q

How are records of NHS Rxs kept in England?

A

PMR - Patient Medication Record

Rx sent to NHS Business Services Authority (NHSBSA) in England

108
Q

How long is the POM kept for?

A

2 years after last entry

109
Q

What must be included on POM register entries for private Rxs only?

A
  • Price paid (no VAT added)
  • stamp script with branch stamp
110
Q

Rxs for what POMs are exempt from record keeping via POM register?

A
  • oral contraceptives
  • Schedule 2 Controlled Drugs (ONLY where a separate CD record is made)