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Pre-Reg Exam > Law > Flashcards

Law Flashcards

1
Q

Where can GSL medicines be supplied?

A
  • sold in retail outlets that can close to the public

- sold in registered retail pharmacy under a responsible pharmacist - these can be out for self-selection

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2
Q

Where can P medicines be supplied?

A

In a registered retail pharmacy by/under supervision of an RP.

P Meds HAVE to be behind the counter/not accessible by self-selection.

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3
Q

Where can POM medicines be supplied?

A

Requires a prescription by an appropriate prescriber.

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4
Q

What is a PO (Pharmacy Only) medicine?

A

A GSL medicine that a manufacturer restricts sale through via pharmacies.

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5
Q

True or False. A pharmacist always has to sell a GSL medicine but doesn’t always have to sell a P medicine.

A

FALSE - the pharmacist have the power to refuse sale/supply of any medicines if it goes against their clinical judgement.

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6
Q

True or False. GSL medicines can only be sold when a pharmacist has assumed the role of the responsible pharmacist.

A

TRUE - can also be sold during the 2 hours of their allowed absence as they have assumed the role.

Only cannot be sold in a pharmacy when an RP hasn’t signed on for the day.

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7
Q

Appropriate practitioners can prescribe medicines - who are they?

A
  • Doctors, Dentists, Vets
    (Dentists can prescribe on an NHS Rx only drugs of the dentist formulary)

Independent Prescribers:

  • Nurse
  • Pharmacist
  • Paramedic
  • Optometrist (no CDs or parenteral POMs)
  • Podiatrists
  • Physiotherapists
  • Therapeutic Radiographers (POMs, certain CDs, off-label medicines)

Supplementary Prescribers according to a clinical management plan:
- Pharmacists, midwives, nurses, chiropodists, dietician, podiatrist, physiotherapist, radiographer, optometrist

Community Nurse Prescriber

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8
Q

What is the maximum amount of pseudoephedrine that can be sold?

A

720mg

60mgs (x12 tabs)

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9
Q

What is the maximum amount of ephidrine that can be sold?

A

180mg

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10
Q

True or False? Pseudoephedrine and ephedrine can be supplied together on prescription.

A

TRUE - they can be supplied on a prescription but NOT sold together as they can be abused to produce methyl amphetamine

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11
Q

True or False?

A pharmacist can make an advanced supply of EHC.

A

TRUE.

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12
Q

Which EHC can be supplied to someone who is 15?

A

Ella One (Ulipristal)

Levonelle is 16+ only

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13
Q

What is the maximum pack size of Paracetamol/Aspirin that can be sold?

A

MAXIMUM - 100 tabs

in practice its 3 x 32 = 96 tabs

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14
Q

What is the maximum pack size of effervescent paracetamol/aspirin that can be sold?

A

NO maximum pack size on any liquids, effervescent, granules or powders.

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15
Q

What is the only indication of codeine/dihydrocodeine OTC?

A

Short-Term treatment of acute, moderate pain not relieved by simple analgesia.

NOT for any coughs/colds etc.

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16
Q

What is the maximum pack sizes of codeine/dihydrocodeine?

A

32 dose units

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17
Q

What is the maximum pack size of effervescent codeine/dihydrocodeine?

A

32 dose units - SAME as normal tabs.

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18
Q

What is the legal required wording on the packs of codeine/dihydrocodeine products?

A
  • ‘can cause addiction, for three days use only’

- ‘can cause addiction or headache if used continuously for more than 3 days’

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19
Q

What are the legal requirements of a general prescription (NHS + Private)?

A
  1. Name + Address of Patient
  2. Prescriber Particulars + Address of Prescriber
  3. Age (if under 12)
  4. Date
  5. Signature
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20
Q

What is the validity of private POM prescriptions?

A

6 months from the date of the SIGNATURE

- cannot be from the ‘appropriate’ date as with NHS prescriptions

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21
Q

What is a repeatable prescription?

A

ONLY for private prescriptions - means they contain a direction which means they can be dispensed more than once

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22
Q

On a repeatable prescription, if a value isn’t stated, how many times can the prescription be dispensed?

A

TWICE

unless an oral contraceptive - can be repeated 5 times to give a total of 6 DISPENSED items

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23
Q

What items can be prescribed on a repeatable prescription?

A

Schedule 4 + 5
POM

NOT schedule 2/3

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24
Q

When must the first dispensing be made for repeatable prescriptions?

A

within the first 6 months of the date
(within 28 days for a Schedule 4)

no legal limit on the remaining repeats of a repeatable prescription

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25
Q

If you have dispensed a repeatable prescription for the first time, where does the prescription go?

A

BACK to the patient - remains their property and can take to different pharmacies.

Mark the prescription with pharmacy details + date of supply.

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26
Q

What are the legal requirements of an entry for a private prescription into the POM register?

A
  • Supply Date
  • Prescription Date
  • Medicine Details (name, quantity, formulation, strength) - NOT legal requirement
  • Prescriber Name + Address
  • Patient Name + Address
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27
Q

How long should private prescriptions be retained for?

A

2 years

  • from the date of sale/supply for normal private prescriptions
  • from the date of the LAST sale/supply for repeatable prescriptions
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28
Q

How long should private prescriptions for Schedule 2 + 3 be retained for?

A

NOT retained by the pharmacy - sent to the NHS BSA

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29
Q

How long should the POM register be retained for?

A

2 years from the date of the last entry in the register

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30
Q

When should records for a private POM be made?

A

ON the day of the sale/supply or on the next day following

oral contraceptives are exempt

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31
Q

When should records for a private CD Schedule 2’s be made in the POM register?

A

records NOT kept in the POM register - only in the CD register

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32
Q

What can dentists prescribe on an NHS prescription?

A

ONLY medicines included in the Dentist’s Prescribers Formulary

but can prescribe ANYTHING on a private prescription

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33
Q

True or False. Faxed prescriptions can be dispensed against as they are proof a prescription exists.

A

FALSE. Faxed prescriptions are NOT legal prescriptions + carry many risks.

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34
Q

What are the legal requirements of a prescription from an EEA country/Switzerland?

A

SAME as a normal UK private prescription EXCEPT:

- need full details of the prescriber (email address, telephone, fax number, work address, professional qualifications)

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35
Q

TRUE or FALSE. Prescriptions in another language is not legally valid.

A

FALSE. Can supply against the prescription provided there are enough details to ensure a safe supply.

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36
Q

What medicinal products are allowed to be prescribed on a prescription from EEA countries/Switzerland?

A

GSL, P, POM, Schdeule 4 + 5

Schedule 1, 2, 3 (incl. Phenobarbital) + unlicensed medicines aren’t allowed

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37
Q

TRUE or FALSE. EEA/Switzerland prescribers or patients from these countries cannot request emergency supplies.

A

FALSE. They can, it is legally possible.

Follow usual procedures but remember that prescriptions at request of prescribers still need tone received within 72 hours.

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38
Q

What are the conditions of military prescriptions?

A
  • community pharmacies have to have a Ministry of Defence contract + invoice the MOD directly
  • if they don’t have an MOD contract, treat as a private prescription
  • written on an FMED 296 military form
  • Schedule 2 + 3 cannot be dispensed on these forms
  • they’re usually computer generated + have a British Forces Post Office address stamp
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39
Q

What are the legal requirements of labels of dispensed medicinal products?

A
  • Name of the Patient
  • Name + Address of Pharmacy
  • Date of Dispensing
  • Name of the Medicine
  • Directions for Use
  • Precautions relating to the use of the medicine
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40
Q

What is recommended to been the labels of dispensed medicinal products?

A
  • keep out of the reach and sight of children

- use this medicine only on your skin (where applicable)

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41
Q

What are the requirements of broken bulk containers (in anticipation of prescriptions)?

A
  • Name of the medicine
  • Quantity of the medicine in the container
  • Quantitative particulars of the medicine (ingredients)
  • Handling + storage requirements where appropriate
  • Expiry Date
  • Batch Ref No.

e.g. packing down Gaviscon 500mLs into 100mL bottles ready for prescriptions

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42
Q

True or False. Only an appropriate practitioner can administer parenteral POM’s?

A

FALSE - can be an appropriate practitioner/someone in accordance with the directions of an appropriate practitioner

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43
Q

What are the exemptions for the administering of parenteral POM’s?

A
  • Naloxone for a drug-related overdose
  • Adrenaline in anaphylaxis
  • Smallpox vaccine after exposure
  • Midwives/Paramedics certain POM’s in certain conditions
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44
Q

What is a patient specific direction?

A

usually, a WRITTEN instruction from a Dr/Dentist/Non-Medical Prescriber for a medicine to be supplied to a named patient

e.g. inpatient charts

although can be verbal/telephoned

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45
Q

What are the legal requirements of a patient specific direction?

A

there are no legal requirements - law doesn’t stipulate what should be included but there should be enough info that the medicine can be administered safely

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46
Q

What are the scenarios sales + supplies of POMs can be made without a prescription?

A
  • PGD
  • PSD
  • Emergency Supplies
  • Optometrist/Podiatrist Signed Orders
  • Salbutamol & Adrenaline to Schools
  • Naloxone to individuals providing recognised drug treatment services
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47
Q

What is a Patient Group Direction?

A

a set of written directions that allows the supply/administration of a specified medicine by named health professionals to a DEFINED group of patients

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48
Q

How should medicines of a Patient Group Direction be labelled?

A

in the same way as if supplied against a prescription

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49
Q

Which prescribers can make a request for an emergency supply of a medicine?

A

the same as appropriate practitioners

  • all IPs
  • Dr/Dentists
  • supplementary prescribers
  • EEA/Swiss
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50
Q

What classes of medicines can be requested by a prescriber on an emergency supply?

A

Only GSL, P, POM’s, Schedules 4 + 5

NOT Schedule 1, 2, 3 (except for phenobarbital for specific prescribers)

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51
Q

What prescribers are able to request phenobarbital for the treatment of epilepsy on an emergency supply?

A
  • Dr/Dentist
  • Nurse/Pharmacist Prescriber
  • Supplementary Prescriber
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52
Q

What are the conditions of an emergency supply at the request of a prescriber?

A
  • must be made by an appropriate prescriber
  • must be satisfied that it’s an emergency
  • prescription needs to be received in 72 hours
  • supplied in accordance with the direction of the prescriber
  • entry in the POM register
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53
Q

What needs to be recorded for the emergency supply at the request of a prescriber?

A

GOING to receive a prescription, so:

  • Name + Address of Prescriber
  • Name + Address of Patient
  • Name + Quantity of Medicine Supplied
  • Date the medicine is supplied
  • Date on the prescription (when it arrives)
  • Date on which the prescription is received (when it arrives)
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54
Q

What are the conditions of an emergency supply at the request of a patient?

A
  • interview the patient
  • establish an immediate need
  • must have been prescribed before by a UK, EEA/Swiss prescriber
  • satisfied with the dose
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55
Q

What medicines can be supplied for an emergency supply at the request of a patient?

A

POM

NO Schedule 1, 2, 3 (except for phenobarbital - but these patients need to have their prescribers as UK-registered)

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56
Q

TRUE or FALSE. You cannot make an emergency supply of a medicine at the request of a patient if a Dr’s surgery is open.

A

FALSE.

Sending someone to a surgery may not always be the most appropriate option.

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57
Q

What medicines can EEA/Swiss prescribers request as an emergency supply?

A

POM

NOT Schedule 1, 2 OR 3 (incl. phenobarbital - can’t do this)

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58
Q

What medicines can patients of EEA/Swiss prescribers request as an emergency supply?

A

POM

NOT Schedule 1, 2 OR 3 (incl. phenobarbital) + UNLICENSED in the UK

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59
Q

What is the maximum treatment length of an emergency supply at the request of the patient?

A

Phenobarbital, Schedule 4 + 5 = 5 days

Other POM’s = 30 DAYS

  • unless to the nearest small pack size available (e.g. inhaler, cream, insulin)
  • unless an oral contraception = full treatment cycle to be supplied
  • smallest quantity to provide a full course of treatment of liquid Abx
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60
Q

What needs to be recorded for the emergency supply at the request of a patient?

A
  • Name + Address of Patient
  • Info on the Nature of Emergency
  • Name if drug + quantity
  • Date POM supplied
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61
Q

When do records for emergency supply have to be made?

A

SAME day or next day if more practical.

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62
Q

What is a signed order?

A

NOT a prescription = request from an optometrist/podiatrist/school for a supply of a POM directly to a patient

need a record in the POM register

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63
Q

TRUE or FALSE. Signed order still have to comply with prescription requirements.

A

FALSE - Optometrist/Podiatrist

but still need to be satisfied with the advice on there

(schools - additional requirements)

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64
Q

TRUE or FALSE. Optometrists and Podiatrists can’t authorise prescriptions unless they’re IP’s, which is why they use signed orders.

A

TRUE.

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65
Q

What medicines are able to be supplied from a signed order of an optometrist/podiatrist?

A

one which can be legally sold/supplied by the optometrist/podiatrist rather than one the they can only administer

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66
Q

What information legally needs to be included on a signed order from a school for adrenaline/salbutamol?

A
  • Name of the School
  • Product Details (strength)
  • Purpose for which the product is required
  • Total quantity required
  • Signature of the principal/head teacher

Headed Paper - not a legal requirement

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67
Q

What records need to be made for a signed order from a school for adrenaline/salbutamol?

A

Entry in the POM Register:

  • Name, Address, Trade, Business, Profession
  • Name, Quantity of Medicine
  • Purpose for which Sold/Supplied
  • Date POM Supplied

RETAIN Signed Order for 2 years

68
Q

Who can supply naloxone for the purpose of saving a life in an emergency opioid overdose?

A

‘persons employed/engaged in drug treatment services provided by, on behalf of or under arrangement made by one of the following bodies

  • NHS body
  • local authority
  • Public Health England/agency’

e.g. a community pharmacy that does needle exchange

69
Q

What are the conditions of supplying oral retinoids under the PPP?

A
  • prescription validity is 7 days
  • should be dispensed on the date it’s written (ideally)
  • quantity only for 30 days
  • monthly review
  • effective contraction
70
Q

When can’t oral retinoids be supplied?

A
  • repeat prescriptions
  • faxed prescriptions
  • emergency supply at request of patient
71
Q

When can oral retinoids be supplied via emergency supply?

A
  • at the request of a PPP specialist prescriber only

- confirmation that pregnancy status is negative in the previous 7 days

72
Q

What should be done upon dispensing sodium valproate to women of child-bearing age?

A
  • provide patient card each time valproate is dispensed
  • dispense in original packs where possible OR ensure PIL/warning labels on white boxes
  • ensure label doesn’t cover the warnings
  • importance of annual review
  • report side effects via Yellow Card Scheme
  • if planning pregnancy/become pregnant = KEEP taking but need to refer to GP urgently
73
Q

What is a biologic?

A

medicine made from human, animal, microorganism origins

e.g. insulin, vaccines, blood prodcuts

74
Q

What is a biosimilar?

A

a biologic similar to an already licensed biologic medicine

specifically developed to treat the same disease, but marketed after the original product and after the patent has ended

enhances access and reduces costs

(e.g. same as a generic for normal meds, but because it’s biologics and they’re complicated you can’t make exact copies, they’ll always be a bit different)

75
Q

Are biologics and biosimilars interchangeable?

A

NO. Biosimilars are still prescribed by brand name to avoid any automatic substitution and decisions to change must be made by prescribers.

76
Q

What is an advanced therapy medicinal products (ATMPs)?

A

a biological product that is gene therapy, somatic cell therapy or tissue engineered product

(e.g. CAR-T therapy)

77
Q

What can Drs/Dentists prescribe?

A
  • Schedule 2-5 CDs
  • Unlicensed medicines
  • Emergency Supply: Schedule 4 + 5, POMs (+ phenobarbital)

CAN supply cocaine, diamorphine, dipopanone for treating addiction but need a home office license

78
Q

What can Vets prescribe?

A
  • Schedule 2-5 CDs
    (2 + 3 on standardised forms)
  • Unlicensed medicines
  • NO emergency supplies
79
Q

What can nurse/midwife IP’s prescribe?

A
  • Schedule 2-5 (but NOT cocaine, diamorphine, dipopanone)
  • Unlicensed Medicines
  • Emergency Supply: Schedule 4 + 5, POMs (+ phenobarbital)
80
Q

What can optometrist IP’s prescribe?

A
  • NO CDs
  • NO unlicensed (off-label permitted)
  • Emergency Supply: yes to the items that can be prescribed
  • NO parenteral
81
Q

What can Paramedic IPs prescribe?

A
  • NO CDs
  • NO unlicensed (off-label permitted)
  • Emergency Supply - YES but no Schedule, 1, 2, 3 and no phenobarbital
82
Q

What can Pharmacist IPs prescribe?

A
  • Schedule 2-5 (but NOT cocaine, diamorphine, dipopanone)
  • Unlicsened medicines
  • Emergency Supply - no Schedule 2, 3, but yes phenobarbital
83
Q

What can Physio IPs prescribe?

A

Certain CDs:

  • PO: diazepam, dihydrocodeine, lorazepam, morphine, oxycodone, temazepam
  • Ini: morphine
  • Patches: Fentanyl

ONLY off-label (not unlicensed) meds
Emergency Supply - YES but no Schedule, 1, 2, 3 and no phenobarbital

84
Q

What can podiatrist IP’s prescribe?

A

Certain CDs;
- PO: diazepam, dihydrocodeine, lorazepam, temazepam

ONLY off-label (not unlicensed) meds
Emergency Supply - YES but no Schedule, 1, 2, 3 and no phenobarbital

85
Q

What can therapeutic radiographer IPs prescribe?

A
  • NO CDs
  • ONLY off-label, not unlicensed
  • Emergency Supply - YES but no Schedule, 1, 2, 3 and no phenobarbital
86
Q

What can supplementary prescribers prescribe?

A

SAME as Drs/Dentists etc but they HAVE to be included within a written clinical management plan

87
Q

What can community practitioner nurse prescribers prescribe?

A

NO CDs
NO off-label OR unlicensed (other than nystatin for neonates)
YES to emergency supplies

88
Q

What can EEA/Swiss prescribers prescribe?

A
  • Schedule 4 + 5 CDs Only
  • NO unlicensed or off-label medicines
  • Can authorise an emergency supply (but not of schedule 2 or 3, no phenobarbital)
89
Q

How are pharmacies exempt from wholesale distribution authorisations (licenses)?

A

pharmacies supplying stock to another pharmacies in the same legal entity = no WDA

pharmacies/hospitals supplying small quantities to HCPs for onward treatment/supply to their patients = no WDA provided that

  • transaction is occasional
  • quantity of medicines is small
  • supply is not-for-profit
  • supply not for onward wholesale distribution
90
Q

When is a wholesale distribution authorisation (license needed)?

A
  • anyone trading medicines to someone who is not a patient

if trading CDs - also need a home office license

91
Q

What records need to be made for a wholesale deal/supply to a HCP or organisation?

A

EITHER:
- retain the signed order/invoice for 2 years from date of supply

OR
- make an entry in the POM register

92
Q

What are the classes of veterinary medicines?

A
  • POM-V (prescribed by a vet + supplied by vet/pharmacist)
  • POM-VPS (prescribed + supplied by vet, pharmacist or suitable person with oral/written Rx)
  • NFA-VPS (non-food animals, no Rx required, supply by vet, pharmacist or suitably qualified person)
  • AVM-GSL - available for general sale anywhere
93
Q

Which classes of veterinary medicines require a prescription?

A
  • POM-V
  • POM-VPS

(all private prescriptions)

94
Q

What are the prescription requirements for a veterinary medicine?

A
  • Name, Address, Telephone No, Qualifications of Prescriber
  • Name + Adress of Owner
  • Identification of Species + Address
  • Date
  • Name + Quantity, Dose, Administration of Medicine
  • Warning Labels
  • Signature
95
Q

How long a veterinary medicines valid for?

A

6 months (or shorter if indicated by the prescriber)

all repeatable supplies must be made within 6 months or shorter

CDs - 28 days for Schedule 2, 3, 4

96
Q

What are the prescription requirements for a veterinary CD?

A
  • CD 2 + 3 - no standardised form but needs to have ‘prescribed for treatment of an animal/herd under my care’
  • needs Royal College of Veterinary Surgeons registration number
  • treatment shouldn’t exceed 28 days
  • usual CD requirements (on human prescriptions

CD prescriptions retained for 5 years (unlike human private prescriptions)

97
Q

How long should veterinary prescriptions be retained for?

A

5 years

98
Q

What is the veterinary cascade?

A

exemption for when a licensed veterinary product isn’t available, and other medicines can be supplied (e.g. human medicines/unlicensed medicines)

99
Q

What are the steps of the cascade?

A

when a UK licensed medicine (indication + species) isn’t available:

  1. Vet Medicine licensed in NI
  2. GB/NI/UK-wide Vet Med licensed in a different species/condition
  3. GB/NI/UK human medicine OR veterinary medicine licensed outside of the UK
  4. extemporaneous/special manufactured medicine
100
Q

What are the prescription requirements if cannot supply a UK licensed veterinary medicine and follow the steps of the cascade?

A

must contain the wording ‘for administration under the cascade’

101
Q

TRUE or FALSE. As long as the veterinary surgeon has said to, people can buy human GSL/P medicines for their animals.

A

FALSE - illegal to sell/supply unauthorised veterinary medicines unless it takes place under the veterinary cascade

cannot buy OTC from a pharmacy

102
Q

What veterinary medicines need to have a dispensing label?

A

ALL those under the cascade

all those licensed for use in animals are not legally required to have a label

103
Q

What are the labelling requirements of veterinary medicines?

A

ONLY for vet meds under the cascade

  • Name of prescribing surgeon
  • Name + Address of Owner
  • Name + Address of Pharmacy
  • Date of Supply
  • Export date of product
  • Name/description of product or active ingredients
  • Dosage + Administration
  • Special Storage Instructions
  • Warnings/Precautions
  • Withdrawal periods
  • ‘For animal treatment only’
  • ‘Keep out of reach of children’
104
Q

What are the legal requirements of a record of veterinary medicines?

A
  • Name of the medicine
  • Date of the receipt/supply
  • Batch number
  • Quantity
  • Name + Address of supplier/recipient
  • Name + Address of Prescriber
105
Q

What veterinary medicines require the physical presence of a pharmacist when supplying?

A

POM-V, POM-VPS, NFA-VPS

UNLESS authorised in advance and delegated to a competent person to hand out.

106
Q

TRUE or FALSE. Manufacturers of veterinary medicine or those who have a WDA can routinely supply to authorised retailers.

A

TRUE

however, authorised retailers can supply to each other to relieve temporary supply shortages

107
Q

What are the controlled drugs contained in Schedule 1?

A

e.g. hallucinogenics/ecstasy

  • NO therapeutic use
  • Home office license required
  • pharmacists can possess for the purpose of destruction/handing over to a police officer (maintain confidentiality)
108
Q

What are the controlled drugs contained in Schedule 2 and the requirements?

A

Diamorphine, Morphine, Methadone, Oxycodone, Pethidine, Amphetamines, Quinalbarbitone, Ketamine

  • prescription requirements
  • valid for 28 days
  • address of prescriber MUST be UK
  • not able to be repeatable
  • no emergency supply
  • requisition required
  • CD register entry (don’t need to retain invoice)
  • safe custody (except quinalbarbitone)
109
Q

What are the controlled drugs contained in Schedule 3 and the requirements?

A

Buprenorphine, Temazepam, Tramadol, Midazolam, Phenobarbital, Gabapentin, Pregabalin

  • prescription requirements
  • valid for 28 days
  • address of prescriber MUST be UK
  • not able to be repeatable
  • NO emergency supply (except phenobarbital if UK prescriber)
  • retain invoice for 2 years
  • safe custody (except for tramadol, phenobarbital, midazolam, gabapentin + pregabalin)
110
Q

What are the controlled drugs contained in Schedule 4 and the requirements?

A

Part 1: Benzodiaepines, Zopiclone, Sativex
Part 2: Anabolic Steroids, Growth Hormones

  • no prescription requirements
  • valid for 28 days
  • EEA/Swiss and UK prescribers
  • able to be repeatable
  • emergency supply allowed
  • NO invoices or registers
111
Q

What are the controlled drugs contained in Schedule 5 and the requirements (P/POMs)?

A

Codeine, Pholcodeine, Morphine (lower strengths)

  • no prescription requirements
  • valid for 6 months
  • EEA/Swiss and UK prescribers
  • able to be repeatable
  • emergency supply allowed
  • invoices retained for 2 years
112
Q

TRUE or FALSE. A license is needed for a pharmacy to import/export CD schedules 2, 3, 4 + 5?

A

FALSE. All except Schedule 5.

113
Q

TRUE or FALSE. A personal license from the home office is required for those travelling?

A

TRUE for those travelling with more than 3 months supply, otherwise don’t need one.

114
Q

What are the schedules that need particular prescription requirements, need to be on a CD requisition form if private and cannot be repeatable?

A

Schedule 2 + 3

115
Q

Which CDs can be supplied via emergency supply?

A

CD’s 4 + 5

Phenobarbital (3) if the prescriber is from UK/patient’s prescriber’s address is in the UK

116
Q

Which CDs can be supplied on a prescription from an EEA/Swiss prescriber?

A

CD 4, 5 - NOT 2 or 3 OR phenobarbital

117
Q

Which CDs require safe custody?

A

ALL CD 2 + 3 except:
2 - Quinalbarbitone
3 - Phenobarbital, Midazolam, Gabapentin, Pregabalin, Tramadol

118
Q

Which CDs require entry into the CD register?

A

CD 2 only

119
Q

Which CDs do you need to keep invoices for?

A

CD 3 + 5 for 2 years

120
Q

TRUE or FALSE. Requisitions for a CD schedule 2 + 3 must be on an approved requisition form if being provided for the same legal entity.

A

FALSE.

Only if receiving requisitions from a different legal entity does the request need to be on an approved requisition form.

121
Q

TRUE or FALSE. Requisitions must be received in writing by pharmacies before delivery of any Schedule 2 or 3 CDs to a recipient that is NOT another registered pharmacy.

A

TRUE.

However, in an emergency, Drs + Dentists can be supplied with a Schedule 2/3 providing that they supply a prescription in the next 24 hours.

122
Q

What are the requirements of a CD requisition?

A
  • Name + Address of Recipient
  • Profession/Occupation
  • Purpose of Requisition
  • Total Quantity of Drug
  • Signature of Recipient
  • Suppliers Name + Address
123
Q

What is the fate of CD requisition forms?

A

as they are for Schedule 2 + 3 - sent off to NHS BSA

if Veterinary - retain original for 5 years

124
Q

What drugs can a midwife obtain via a CD requisition?

A
  • Diamorphine
  • Morphine
  • Pethidine
125
Q

What are the requirements of a CD requisition of a midwife?

A
  • Name + occupation of midwife
  • Name of patient
  • Purpose
  • Total Quantity
  • Signature of appropriate medical officer (Dr authorised to supervise midwives)
126
Q

What are the legal NHS CD prescription requirements?

A

(Schedule 2 + 3)

  • Name + Address of Patient
  • Name + Address of Prescriber
  • Name of CD
  • Formulation
  • Strength
  • Dose
  • Quantity - words + figures
  • Signature
  • Date - valid for 28 days after appropriate date
127
Q

What are the legal private CD prescription requirements?

A

as normal except:

  • on a standardised form
  • prescriber number ID needed (particular number on a register)
128
Q

What are the legal requirements for a dental CD prescription?

A

must state ‘for dental treatment only’

129
Q

What are the legal requirements for instalment prescriptions?

A
  • must have dose + amount specified separately
  • mark the date of supply + time supply is made
  • first instalment HAS to be within 28 days but then you dispense according tot he instructions (even if it runs over the 28 days)
130
Q

What are examples of doses that are NOT legally acceptable?

A
  • as directed (should be ONE as direct)
  • when required (should be TWO when required)
  • PRN (should be ONE PRN)
  • as per chart
  • titration dose
  • weekly
  • decrease dose by 3.5mL every four days
  • twice a day
131
Q

What are the Home Office approved wording for instalment prescriptions?

A
  • dispense instalments due on pharmacy closed days on a prior suitable day
  • if a collection day is missed, dispense the amount due for any remaining day(s)
  • consult prescriber if 3 or more days missed
  • supervise consumption on collection dyas
  • dispense daily doses in separate containers
132
Q

What amendments can a pharmacist make to a CD prescription?

A
  • minor typographical error or spelling mistake

- add either the quantity in words OR figure if one of them is omitted

133
Q

TRUE or FALSE. Prescriptions for drug misuse can ONLY be collected by the patient themselves.

A

FALSE. As long as the drug misuser writes a letter authorising a named representative to present at the pharmacy (incl. police officers).

Register details of the representative in the CD register.

134
Q

What CDs require to be denatured before disposal?

A

Schedule 2, 3 + 4 (Part 1 - Benzos)

rendered irretrievable

135
Q

What CDs need a witness in order to carry out destruction?

A
  • Stock of Schedule 2’s

Patient returned DOES NOT need a witness.

136
Q

Who is the accountable officer?

A
  • accountable for oversight of monitoring/auditing/management of CDs
  • cannot be an authorised witness themselves, but can authorise other people
137
Q

What are the conditions of denaturing a patient returned control drug?

A

does not need a witness

does not need to be ‘booked out’ of the CD register but an entry should be made in a separate register

138
Q

What are the conditions of denaturing expired/obsolete/unwanted stock?

A

DOES need a witness for Schedule 2 (3 is good practice)

entry need to be made in the CD register

139
Q

How do you denature CDs?

A

grind/crush solid forms, pour liquids, open liquid ampoules, mix powder ampoules, fold patches over on themselves, expel aerosols into water

then ADD to a CD denaturing kit

140
Q

What CD’s require an entry in the CD register?

A
  • Schedule 1
  • Schedule 2
  • Sativex (Schedule 4)
141
Q

What are the requirements of an entry into the CD register following a receipt of CDs?

A
  • Date supply received
  • Name + address of whom received
  • Quantity received
142
Q

What are the requirements of an entry into the CD register following a supply of CDs?

A
  • Date supplied
  • Name + address of recipients
  • Details of authority to possess
  • Quantity supplied
  • Details of person collecting (the patient/representative)
  • If proof of identity was requested/provided
143
Q

What are the requirements when making an entry in the CD register?

A
  • entered chronologically
  • entered promptly
  • ink/indelible
  • unaltered - corrections have to be made with notes/footnotes
144
Q

What are the requirements of a CD register?

A
  • must be kept at the location
  • have to be kept for 2 year s
  • kept in original form/copied
  • be available for inspection
  • be electronic or bound-book
145
Q

TRUE or FALSE. Running balance is a legal requirement in the CD register.

A

FALSE - it is good practice, balance checks are recommended to be carried out once weekly

146
Q

What licensed cannabis products are there and what drug classes to they fall into?

A

Licensed:

  • Sativex (THC + CBD) for moderate-severe spasticity in MS = Schedule 4
  • Nabilone for N&V caused by chemotherapy = POM
  • Epodyolex (CBD) for seizures in Lennox-Gastaut/Dravets syndrome = Schedule 5

Special:
- Dronabinol (Synthetic THC) for treatment of loss of appetite in AIDS and N&V associated with chemo

147
Q

What is a cannabis-based product for medicinal use (CBPM)?

A

HAS TO BE:

  • product contains cannabis, cannabis resin, cannabinol, cannabinol derivative
  • produced for medicinal use in humans
  • product that is regulated as a medicinal product

this DOES NOT include cannabidiol-based products (CBD)

148
Q

What are the conditions of prescribing a cannabis-based product for medicinal use (CBPM)?

A
  • unlicensed
  • Schedule 2
  • specialist GMC register
149
Q

What is CBD oil?

A

marketed as FOOD supplements and regulated bu the Food Standards Agency

they only contain CBD - not THC, as this would then make them fall under medicines legislation

150
Q

What do the terms ‘use by/use before’ mean?

A

means to use BEFORE that month

e.g. 06/22 - don’t use after 31/05/22

151
Q

What does an expiry date of 12/2022 mean?

A

to use by 31/12/22.

152
Q

TRUE or FALSE. All medicines should come in child-resistant containers.

A

FALSE - they have to unless there is a specific request not to or the original pack doesn’t come as a CRC

153
Q

TRUE or FALSE. Homeopathic products hold an MHRA license.

A

FALSE - to hold a license it has to show efficacy, currently the products only need to demonstrate quality + safety.

154
Q

What drugs are considered a significant liability to be abused that can affect driving?

A
  • Amfetamines
  • Clonazepam
  • Diazepam
  • Lorazepam, Oxazepam, Temazepam
  • Methadone
  • Morphine
  • Selegiline (metabolises to amfetamines)
155
Q

What is a statutory medical defence?

A

a defence that exists to protect patients who test positive for the specified drugs when taking them in accordance with advice from a HCP

156
Q

When can a statutory medical defence be raised/

A

if patient was taking legally + driving was NOT impaired

patients can still be prosecuted if the driving was impaired - don’t drive if you feel sleep, dizzy etc. remains the responsibility of drivers to ensure they are safe.

157
Q

In the event of a pandemic, what condition about the emergency supply to a patient is relaxed?

A

no need to interview the patient

able to supply medicines from designated collection points

158
Q

What needs to be included on a responsible pharmacist display notice?

A
  • name of RP
  • GPhC reg number
  • the fact that that is the RP in charge of the pharmacy at that time
  • must be publicly viewable
159
Q

When is a responsible pharmacist notice displayed?

A

when the pharmacist assumes the role of the RP + is left up even during the allowed ‘absence’ time

160
Q

What is legally required for a record in the responsible pharmacy record?

A
  • RP name
  • RP registration no.
  • Date + Time became RP
  • Date + Time stopped RP
  • Date of Absence, time left pharmacy + time of return

records should be made by the RP personally
entries can be made remotely

161
Q

How long should the responsible pharmacist record be kept for?

A

5 years

162
Q

How long is the responsible pharmacist allowed to be absent for?

A

maximum of 2 hours during pharmacy hours (12am-12am)

  • only be absent if pharmacy can run safely + effectively
  • remain contactable to pharmacy staff/arrange for someone else to be contactable
163
Q

What activities can take place when the RP is in charge, and under the supervision of a pharmacist but the pharmacist doesn’t have to be physically present?

A

Assembly Process:

  • Generating labels
  • Dispensing
  • Labelling
  • Accuracy Checking
164
Q

What activities can take place when the RP is in charge but doesn’t require the supervision of a pharmacist (absence)?

A
  • sale of GSL

- processing waste stock/patient returned CDs that AREN’T CDs

165
Q

What activities can take place when there is no RP in charge?

A
  • ordering stock
  • receiving stock (excluding CDs)
  • putting stock away (not CDs)
  • date checking
  • stocking pharmacy with consumables
  • responding to enquiries
  • accessing PMR
  • receiving prescriptions
  • processing prescriptions for NHS
  • delivery person taking medicines to a patient
  • receiving returned medicines (excluding CDs)
166
Q

What activities need to have a pharmacist physically present

A
  • professional check
  • supply/sale of P meds
  • sale/supply of POMs
  • wholesale of medicines
  • emergency supplies

Pre-Reg Exam (8 decks)

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