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Pre reg > Pharmacy law > Flashcards

Pharmacy law Flashcards

1
Q

Maximum supply of pseudoephedrine and ephredine

A

720mg pseudoephredine

180 ephredine

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2
Q

In practice, how many non-effervescent tablets and capsules of paracetamol and aspirin can be sold OTC at any one time?

A

Most OTC pack sizes come in 16 and 32, so in practice the maximum number that be sold is 96

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3
Q

How many codeine/dihydrocodeine capsules/tablets can you sell OTC?

A

<32

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4
Q

What statement should the label state on a box of codeine/dihydrocodeine say?

A

‘Can cause addiction. For three days only.’

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5
Q

What are the standard seven prescription requirements?

A

1) Signature of prescriber (can be electronic)
2) Address of prescriber
3) Date - valid for SIX months
4) Particulars - e.g Type of practitioner
5) Pt name
6) Pt address
7) Age if under 12

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6
Q

Can you supply an advanced supply of EHC?

A

Yes - prior to unprotected sexual intercourse or in case of failure)
Patient should be assessed to ensure that are competent

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7
Q

If there is no number of repeats stated on a private prescription, how many can you dispense (and contraception)

A

You can repeat it ONCE (dispensed twice)

COC - repeat FIVE times (dispensed 6 times)

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8
Q

What controlled drugs can be repeated and which ones cannot?

A

Schedule 4-5 repeateable

Schedules 2-3 not repeatable

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9
Q

What is the legal time limit that the repeats have to be made?

A

Non CD - First dispensed within 6 months and no time limits for repeats
CD - First dispensed within 28 days and no time limits for repeats
Even though no legal time limit for repeats - pharmacists should use professional judgement

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10
Q

How long must private prescriptions for a POM be kept?

A

TWO years from the date of supply or for repeatables from the date of the last sale or supply

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11
Q

How long do POM registers have to be kept?

A

2 years from the date of the last entry

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12
Q

Where do private prescription CD 2-3 have to be submitted to?

A

The relevant NHS agency

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13
Q

What must the POM record include?

A

1) Supply date
2) Rx date
3) Medicine details - name, quantity, formulation and strength
4) Prescriber details - the name and address of the practioner
5) Patient details - the name and address of the patient

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14
Q

What is FMD and what does it aim for? How is it done?

A

Falsified Medicines Directive.
Aims to create a system that ensure medicines supplied in the UK are safe.
It ensures the trade in medicines is controlled to reduce the risk of fake medicines entering the medicines supply chain and reaching patients

1) New security features on pack
2) New electronic scanning authentication process to be undertaken at point of dispensing

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15
Q

Are EEA countries and Switzerland legally recognised in the UK?

What cannot be prescribed on these prescriptions?

A

Yes

1, 2, 3 CDs and medicinal products without a marketing authorisation valid in the UK

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16
Q

Can you supply emergency supply at the request of an EEA or Swiss prescriber?

A

Yes

Standard emergency supply process

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17
Q

If EEA or Swiss emergency request from prescriber - when does Rx need to be received? (This is same for normal emergency supply)

A

Within 72 hours

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18
Q

Legal requirements on a label

A

1) Name of patient
2) Name and address of supply pharmacy
3) Date of dispensing
4) Name of medicine
5) Directions for use
6) Precautions for use
7) Precautions relating to use of medicine

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19
Q

What requirements do RPS recommend being on dispensing label but not legal requirement

A

1) ‘Keep out of reach and sight of children’

2) ‘Use this medicine only on your skin’ where applicable

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20
Q

Can diamorphine/morphine be prescribed under a PGD

A

Yes - if necessary treatment of sick or injured persons

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21
Q

What drugs cannot be supplied in an emergency supply

A

Schedules 1-3, except phenobarbital for treatment of epilepsy

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22
Q

What details need to be written in POM register for emergency supply? (If made at request of prescriber)

A

1) The date the POM was supplied
2) The name and quantity
3) The name and address of the prescriber requesting the emergency supply
4) The name and address of the pt of whom POM supplied
5) The date on the Rx
6) The date on which the RX received

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23
Q

Conditions that need to be met when an emergency supply is made at request of patient?

A
  • Interview (may not always be feasible)
  • Immediate need
  • Previous Tx
  • Dose
  • Not for CDs, except phenobarbital
  • Length (schedule 4 and 5, max 5 days, any other POM no more than 30 days)
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24
Q

What details need to be written in POM register for emergency supply? (If made at request of patient)

A

1) The date the POM was supplied
2) The name and quantity
3) The name and address of the pt of whom POM supplied
4) Nature of emergency

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25
Q

Extra labelling requirement for emergency supply made at request of patient

A

‘Emergency supply’

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26
Q

Who can provide a signed order for salbutamol inhalers/adrenaline autoinjectors (AAI) for a school?

A

By the principal or head teacher

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27
Q

What information should be included in this signed order” (salbutamol inhalers/AAIs) + which info is ideal but not a legislative requirement

A
  • The name of the school
  • The purpose for which product required
  • The total quantity required
  • Signature of the principal/head
  • Ideally appropriately headed paper should be used but not legal
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28
Q

How long does the signed order for salbutamol inhalers/AAIs need to be kept? (what else instead)

A

2 years from the date of supply

OR an entry can be made in the POM register

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29
Q

What must the POM register include if salbutamol inhaler supply made?

A
  • Date POM supplied
    name, quantity and strength
  • name and address of person who who med supplied
  • purpose of supply
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30
Q

How long before pregnant when taking retinoids?

A

At least 1 month

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31
Q

How long are prescriptions valid under PPP?
What is max quantity supplied?
(retinoids)

A

7 days

Max 30 days

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32
Q

What should pharmacists do regarding patients on sodium valporate?

A
  • Have a conversation with female patients of child-bearing age prescribed valporate to find out if they had a review with their doctor and are aware of risks and on PPP
  • Those planning pregnancy should schedule appointment with prescriber and continue with contraception whilst on valporate
  • If there is an unplanned pregnancy whilst on valporate - NOT stop treatment and urgently see prescriber for view
  • Report any suspected side ffects to yellow card scheme
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33
Q

List the types of veterinary medicine classes

A

POM-V - POM that can only be prescribed by a veterinary surgeon and supplied by a vet surgeon or a pharmacist with a written Rx
POM-VPS - POM that can be prescribed and supplied by a veterinary surgeon, a pharmacist or a suitably qualified person on an oral or written prescription. A written Rx is only required if the supplier is not the prescriber
NFA-VPS - A category of medicine for non-food animals that can be supplied by a vet surgeon, pharmacist or suitable qualified person. A written RX not required.
AVM-GSL - An authorised vet med that is available on general sale

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34
Q

Rx requirements for a veterinary Rx

A

Telephone of prescriber
Name and address of the owner
Species of the animal, and its address if different to the owner
Name, quantity, dose, administration instructions and relevant warnings for medicines
‘Prescribed under the veterinary cascade’
Washout period if for food animal
If a CD: the vet’s RCVS number, and ‘the item has been prescribed for an animal or herd under the care of the veterinarian’

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35
Q

How long are veterinary Rx valid for and CDs

A

Valid for 6 months

CD 28 days (2, 3, 4)

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36
Q

Differences between vet and human CD Rxs

A

1) Standardised forms not required for vet Rx - but must state that medicines are ‘prescribed for the treatment of an animal or herd under my care’ for CD 2-3
2) Standardised forms required for human private prescriptions for 2-3
3) Vet Rx should be retained for 5 years not submitted to the relevant NHS agency. Original human prescriptions for sch 2-3 must be submitted to the relevant NHS agency.
4) Highly recommended that the Max supply for CDs is 30 days for humans, good practice for 28 days vets
5) Sch 2 + 3 vets must have RCVS. Human 2 + 3 prescriber identification number

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37
Q

Pharmacies that supply POM-V and POM-VPS need to undertake what each year?

A

An annual audit

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38
Q

Classification of controlled drugs

A

Sch 1 - Have no therapeutic use and a licence is generally required for their production, possession and supply
Sch 2 - Pharmacists and other classes of person have authority to possess supply and procure.
Includes opiates (diamorphine, morphine, methadone, oxycodone, pethidine) and major stimulants (amfetamines)
Sch 3 - Minor stimulants and other drugs (buprenoprhine, tramadol, temazepam, midazolam, phenobarbital), that are less likely to be abused.
Sch 4 - Part 1 (CD Benz) - Contains most of the benzos, non beze hypnotics and Sativex
Part 2 (CD anab) Contains most of the anabolic and androgenic steroids, celbuterol and GH

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39
Q

Applications for obtaining a licence must be supported by a cover letter signed by the prescribing doctor or drug worker, which must confirm:

A

1-4 (part 1).
None required for sch 5
No licence required if travelling less than 3 months. Advised that cover letter supplied signed by prescriber to confirm name of pt, travel plans and name of prescribbed CDs, quantities and dose

40
Q

When would an approved mandatory requisition form must be used to request stock of sch 3-4?

A

Received by hospital - if the request isn’t on behalf of a ward or department in the same entity
OR
Received by community pharmacy - and is a request from a hospital, community, health provided or vet surgeon

41
Q

Drugs that fall under safe custory

A

Sch 1, 2, 3 (except phenobarbital, mazindol, meprobamate, midazolam, tramadol)

42
Q

Which drugs require denaturing?

A

Sch 1 - 4 (part 1) that have been returned to pharmacy or out of date stock

43
Q

Do patient returned CD medicines require a witness

44
Q

Record keeping for returned patient CDs

A

Schedule 2 only should be made in another book other than the CD one

45
Q

Do stock CD meds require an authorised witness to watch denature

A

Yes for schedule 2 stock

46
Q

Record keeping for returned patient CDs

A

Into the CD register for Sch 2

47
Q

Pharmacy Record - How long does it need to be kept?

A

Five years

48
Q

What information needs to be kept in the Pharmacy Record?

A
  • RP name and reg number
  • Date and time they became RP and stopped being rP
  • If you are absent (date, time left and time returned)
49
Q

What arrangements must the RP put in place before being absent

A
  • Pharmacy can continue safelt and effectively
  • Remain contactable and return with reasonable promptness
  • If cannot do this elect someone else
50
Q

What activities cannot be done when RP not there

A
  • Professional check (legal and clinical)
  • Supply of P
  • Handing out POMs to patients
  • Supply of meds under PGF
  • Wholesale of meds
  • Emergency supply of meds at request of pt or HCP
51
Q

What are the limits for RPs of absences in a 24 hour period?

52
Q

What happens to private Rx inbetween repeats

A

Pt retains - can have disepsned from diff pharmacies - the name and address of pharmacy and date supplied needs to be on Rx

53
Q

When must a POM entry be made for private Rx

A

day of or day after

54
Q

What medicines are exempt from being entered into the POM register, when on a private prescription?

A
  • Contraceptives

- CD 2 -> CD book

55
Q

What are the exceptions for prescription requirements for EEA prescriptions?

A

Patient address and age

56
Q

How long can supply of phenobarbital be made for ES

57
Q

Who can supply POM-Vs?

A

A vet

A pharmacist with a prescription from a vet

58
Q

Who can supply POM-VPSs?

A

A vet
A pharmacist with a prescription from a vet
Another suitably qualified person

59
Q

Who can supply NFA-VPSs?

A

A vet
A pharmacist (doesn’t need a Rx)
Another suitably qualified person

60
Q

Who can supply AVM-GSLs?

A

All vets and retailers

61
Q

What are the 4 steps of the veterinary cascade?

A
  1. A licensed medicines for that species
  2. A licensed medicine for another species of indication
  3. A licensed human, or EU veterinary, medicine
  4. An extemp medicine
62
Q

Which vet medicines need an entry to be made in the POM register?

A

POM-V and POM-VPS

63
Q

What records need to be made in the POM register for POM-V and POM-VPSs?

A 
Name of medicine
Date of supply
Batch number
Quantity
Name and address of recipient
If there is a written prescription, the name and address of the prescriber
64
Q

For which CDs do prescription requirements apply to?

A

CD 2s and 3s

65
Q

How long are CD Rx valid for?

A

1-4 - 28 DAYS

5 - 6 MONTHS

66
Q

Which CDs can only be prescribed by a UK-based prescriber?

67
Q

Which CDs can EEA and Swiss prescribers prescribe?

68
Q

Which CDs can be repeatable on prescription?

69
Q

Which CDs can be requested by ES?

A

4 + 5 (Phenobarbital only for sch 3)

70
Q

Which CDs can only be given to other professionals with a legal requisition?

71
Q

Which CDs must have their invoices retained for 2 years?

A

CD 3s and 5s

72
Q

What type of form must be used for CD requisitions?

73
Q

A registered midwife may use a midwife supply order to obtain the following CDs:

A

Diamorphine
Pethidine
Morphine

74
Q

What are the extra CD prescription requirements?

A

Address of the prescriber must be in the UK
Formulation must be stated
Strength should be stated if product comes in multiple strengths
Total quantity in words and figures
‘For dental treatment only’ if applicable
Clear doses
Valid installment directions if applicable

75
Q

What are valid installment directions? (CD)

A

Amount of medicine per installment

Interval of time between each installment

76
Q

What actions are required when a patient or representative is picking up a CD 2?

A

ID (if not known)

77
Q

What details are required when a HCP is picking up a CD 2 for a patient?

A

Evidence of ID
Name of HCP
Address of HCP

78
Q

Which two sch 3 drugs require safe custory

A

Buprenorphine and temazepam

79
Q

Which CDs must be entered into the CD register when received and supplied?

A

CD 2 and sativex (sch 4 part 1)

80
Q

What must be recorded for CD 2s received into stock?

A

Date supply received
Name and address from who received
Quantity received

81
Q

What must be recorded for CD 2s supplied?

A 
Date supplied
Name and address of recipient
Prescriber details
Quantity supplied
Details of person picking up the CD
Whether proof of ID was requested
Whether proof of ID was shown
82
Q

Is CD balance legally required?

A

No, but good practice

83
Q

What is the only CD law involving schedule 5s?

A

They are exempt from virtually all Controlled Drug requirements other than retention of invoices for two years

84
Q

Which CDs can be dispensed by installments?

85
Q

Who issues the personal export licence?

A

The Home Office

86
Q

What should be done with private Rx for CD 2 and 3s after dispensing?

A

Send to the relevant NHS agency

87
Q

What should be done with requisitions for CD 1-3 from Drs?

A

Send to relevant NHS agency

88
Q

How can a medicine be told apart from a medical device during the dispensing process?

A

Device - CE on it

89
Q

What should a borderline substance be endorsed with by the prescriber?

90
Q

What are the 3 categories of the drug tariff? And what are they?

A

A - It includes popular generics, which are widely available. The price is based on a weighted average of the List Prices from 2 wholesalers and 2 generic manufacturers
C - Items that are based on a particular brand or manufacturer
M - It includes drugs that are readily available, where the Department of Health and Social Care calculates the reimbursement price based on information submitted by manufacturers

91
Q

OOP endorsement meaning

A

The out of pocket (OOP) expenses endorsement enables community pharmacy contractors to claim payment, where in exceptional circumstances, the contractor has incurred expenses in obtaining eligible products, e.g. postage and packaging

92
Q

Superintendent pharmacists should review their pharmacy’s SOPs at least every…

93
Q

Which CD classes are repeatable?

94
Q

What is the standardised form that private Rx for CD 2 and 3 must be on?

95
Q

How many audits must community pharmacies complete per year? Who decides the topic?

A

2: one clinical audit decided by the pharmacy, and one on a topic determined by NHS England

Pre reg (45 decks)

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