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Pharm Y2S2 > Law Exam > Flashcards

Law Exam Flashcards

1
Q

What are the 5 sections of control of the HMR 2012?

A 
Manufacture
Sale
Supply
Import
Authorisation
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2
Q

What are the two licensing authorities?

A

MHRA

European Medicines Agency

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3
Q

Define a medicinal product.

A 
Any substance(s) presented as having properties of preventing/treating disease in humans. 
Administrable to humans with a view to restoring/correcting physiological function or making medical diagnosis
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4
Q

Define an authorised medicinal product.

A

A product with one of:

  • marketing authorisation as a medicine
  • Certificate of registration as homeopathic
  • Traditional herbal registration as herbal remedy
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5
Q

Define a relevant medicinal product.

A

Medicinal product with marketing authorisation, not registrable homepathic or traditional herbal

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6
Q

Define borderline substances.

A

Products not easily distinguished as medicines, food supplements and cosmetics

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7
Q

What defines a borderline substance as medicinal?

A

If it contains active pharmacological substances or makes medicinal claims

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8
Q

Give examples of medical devices.

A

Sutures
Dressings
Contact lens care products

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9
Q

Under what legal document are medical devices addressed?

A

Medical Device Regulations 2002

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10
Q

What are the three available licenses for medicines?

A

Marketing authorisation
Certification of registration as homeopathic
Traditional herbal registration

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11
Q

What is marketing authorisation?

A

Required by all relevant medicinal products for sale/supply

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12
Q

What happened upon implementation of licensing requirements for medicines?

A

Any product on the market prior were granted a product license of right, became marketing authorisation in 1994

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13
Q

What are the three application types for MA?

A

New active substances
Abridged- generic pre-existing products
Biological/biotechnology products

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14
Q

What must an MA application include? (12 things total)

A 
Name/address of applicant
Name/address of manufacturer
Name of medicinal product
Details of product constituents
Evaluation of potential environmental risks
Data on indications, contraindications, clinical studies etc
Pharmacovigilence system
SPC
Packaging
Leaflet
Proposed legal category
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15
Q

How long is an MA granted for?

A

5 years

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16
Q

What records must license holders keep?

A

Adverse reports
Sale/supple
Source of all materials
Periodic safety update

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17
Q

On what grounds may the MHRA reject a product name?

A

Where it causes confusion, is misleading or otherwise unsafe

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18
Q

What are the 4 stages of clinical trials?

A
  1. 20-80 patients to determine dosage, side effects etc
  2. 100-300 patients to determine efficacy
  3. 1000-3000 patients to confirm dose, side effects, indication
  4. post marketing studies
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19
Q

What are the requirements of all container and packaging labels?

A

Easily legible
Comprehensible
Indelible
Where there is more than one language, same particulars must appear in each
Name expressed in braille on outer packaging

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20
Q

What are the labelling requirements for outer and immediate packaging? (18 total)

A 
Name of product
Strength and form
Intended use in...
Common name of substances up to 3
Statement of active substances (qualitative and quantitative) per unit dosage
Form/contents by weight or volume
List of excipients (all in injectables, topical and eye preparations)
Method/route of administration
Space to indicate prescribed dose
Store out of reach and sight of children
Special warnings
Expiry date
Storage/disposal requirements
MA number and holder details
Batch number
Instructions for use where it is not a POM
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21
Q

What are the labelling requirements for blister packs?

A 
Name
Strength and form
Intended for...
Common name of active substances up to 3
Name of MA holder
Expiry date
Batch number
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22
Q

What are the additional labelling requirements for paracetamol?

A

‘Contains paracetamol’ unless stated in the name
‘Do not take more than the medicine labels tells you to. If you do not get better consult your doctor’ adjacent to directions for use
‘Talk to a doctor at once if you take too much of this medicine, even if you feel well. (This is because too much paracetamol can cause delayed and serious liver damage)’ (only requirement where there is no leaflet included)

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23
Q

What does a manufacturers license allow you to do?

A

Manufacture and assemble licensed products (with MA)

Export and import to countries outside the EEA

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24
Q

What does a manufacturer specials license allow you to do?

A

Manufacture and assemble unlicensed products

Supply made in response to unsolicited order for patient under direct care of requestee with specific needs

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25
Q

What does a manufacturers license for investigational products allow you to do?

A

Manufacture and assemble products for phases 1-3 of clinical trials

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26
Q

What are two additional manufacturers licenses available?

A

For exempt advanced therapy

For non-orthodox practitioners

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27
Q

What does a wholesale dealers license allow you to do?

A

Wholesale of POM, P, GSL and traditional herbal medicines

Import of unlicensed products from inside EEA

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28
Q

Who may persons holding a wholesale dealers license distribute to?

A

Holder of WL relating to particular products
Holder of EEA equivalent license
Persons who may lawfully sell, supply or administer medicines

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29
Q

How long must distribution records be kept?

A

5 years

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30
Q

Who is exempt from wholesale/manufacturing licensing? Under what circumstances?

A

Pharmacist may manufacture and assemble products
Doctors and dentists may prepare and assemble products
Nurses and midwives may assemble products
Herbalists may prepare and assemble herbal medicines
MUST- be within the course of their practice, for patient under their care who is present, in lockable premises

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31
Q

Under what circumstances is a WDL not necessary?

A

Manufacturers marketing their own products for which they hold MA
Import to specific individual or products intended to be re-exported without alteration

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32
Q

Under what circumstances are food supplements not exempt from licensing?

A

Promoted to practitioners
Oral administration where there is specific written benefit for disease
Vitamins with no written direction for dosage
Vitamins with daily doses exceeding specific values

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33
Q

Under what circumstances are cosmetics not exempt from licensing?

A

Containing antibiotic
0.004% or more of any hormone
Hexachlorphane over 0.1% (providing cautions are labelled clearly below 0.1%)
Resorcinal over 1%

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34
Q

What are the three responsible bodies for advertising?

A

Advertising standards authority
Proprietary association of GB
Prescription medicines code of practice authority

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35
Q

What are the conditions of giving medicinal samples to professionals?

A

Comply with limited number of annual supples
Marked as free sample
Maximum smallest presentation available for sale
Supply against written and signed request

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36
Q

Define a herbal medicinal product.

A

Medicinal product whose active ingredients are herbal substances or preparations

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37
Q

What is a herbal substance?

A

Plant, algae, fungi, lichen or unprocessed exudate defined by its botanical name and the part of the plant it came from

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38
Q

What is a herbal preparation?

A

Obtained by subjecting a herbal substance to processes such as extraction, concentration, distillation and fermentation

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39
Q

Give examples of herbal preparations.

A

Essential oils
Tinctures
Extract

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40
Q

What is unique about herbal practitioners?

A

No need to be registered with Health and Care Professionals Council

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41
Q

What are the 3 types of herbal medicines.

A

Licensed, with MA
Registered traditional
Unlicensed, not produced industrially

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42
Q

What are the two types of herbal medicine suppliers?

A

Dealers

Practitioners

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43
Q

When are unlicensed herbal medicines supplied?

A

For an individual based on a one-to-one consultation with said individual to meet their needs. Practitioner accepts liability

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44
Q

What does HMR regulation 3 state about supply of herbal medicines?

A

Restrictions to sale/supply do not apply if the product is manufactured or prepared by a herbalist for administration to an individual who is present

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45
Q

What are the 3 herbal substances that are not permitted for import, sale or supply by medicines for human use orders?

A

Aristolochia
Kava-kava
Senecio

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46
Q

What is Part I of the HMR 2012 schedule 20 for?

A

Dictates the herbal substances that cannot be sold/supplied

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47
Q

What substances are in Part I of HMR 2012 schedule 20?

A 
Areca
Canadian hemo
Embelia
Male fern
Strophanthus
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48
Q

What is Part II of the HMR 2012 schedule 20 for?

A

Dictates the herbal substances that cannot be sold/supplied over a certain specified dose/strength

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49
Q

What substances are in Part II of HMR 2012 schedule 20?

A 
Aconite
Adonis vernalis
Belladonna herb
Conium leaf
Ephedra
Lobelia
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50
Q

What is aconite?

A

Also known as monkshood, a poisonous plant that is particularly toxic to the heart

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51
Q

What is the exception to HMR 2012 schedule 20?

A

Pharmacists may sell from a registered premises substances containing part I or II substances

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52
Q

What can herbal dealers/shopkeepers sell?

A

GSL herbals
Registered traditional herbal medicines
Foods/cosmetics

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53
Q

What is the THM directive of 2004?

A

Transition of herbal medicines to become registered, happened over 7 years making registration legal from April 2011

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54
Q

What is HMR 2012 regulation 125?

A

Allows use of herbal medicines without the need for a medical practitioner to diagnose or monitor treatment

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55
Q

What are the requirements for products included in HMR 2012 regulation 125?

A

For oral, topical or inhaled administration

In medical use for 30 years and continuous use in the EU for 15 years

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56
Q

What are the labelling requirements for traditional herbal medicinal products?

A

Clearly stated that it is a THMP
Use for specific purposes
Consult doctor where symptoms do not improve or adverse effects occur that are not stated

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57
Q

What must advertising of THMP state?

A

Use is based upon long standing used as a traditional remedy

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58
Q

What are homeopathic medicinal products?

A

Products based on the theory that ‘like cures like’ at low dilutions
No therapeutic indication is permitted

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59
Q

What is the National Rules scheme 2006?

A

Registration of homeopathic medicinal products based on safety and efficacy for self treatment of minor symptoms and conditions

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60
Q

Under what circumstances are homeopathic medicinal products registered without using the national rules scheme?

A

If pre-existing upon implementation of Medicines Act, given a product license of right

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61
Q

What is the GHS?

A

Globally harmonised system for labelling and classification of chemicals

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62
Q

What regulation controls chemical labelling? When was it introduced?

A

Classification, labelling and packaging regulation 2008, came into full effect in 2015

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63
Q

Give examples of physicochemical dangers associated with chemicals.

A

Explosive
Flammable
Oxidising

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64
Q

Give examples of health dangers associated with chemicals.

A 
Toxic
Harmful
Corrosive
Irritant
Carcinogenic
Mutagenic
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65
Q

Under what circumstances do the label requirements for chemicals not apply?

A

Chemicals in their finished state intended for use as medicines, medical devices, food, cosmetics, feeding stuffs

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66
Q

What are the main aims of a chemical label?

A

Tell anyone using/handling of hazards

Brief precautionary advice

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67
Q

What are the requirements of a chemical label?

A 
Substance name and quantity
Contact details of supplier
Firmly affixed
Clear and indelible
To read horizontally
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68
Q

What are the requirements of chemical packaging?

A

Must prevent chemical escaping
Not be adversely affected by chemcial
Strong enough to withstand normal handling
If for general sale, child resistant with tactile danger warnings

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69
Q

Give examples of non-medicinal products used in the course of practice of a chiropodist. How are these regulated?

A 
Liquid phenol
Pyrogallol
Monochloroacetic acid
Salicylic acid
Regulated as medical devices if placed on the market with medicinal claims
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70
Q

Give examples of poisons used as medicinal products. How are these regulated?

A

Arsenic
Strychnine
Regulated by HMR 2012

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71
Q

How are non-medical poisons regulated and ordered?

A

Poisons Act 1972 splits poisons into 4 lists, regulated and reportable explosive precursors and poisons

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72
Q

Under what circumstances do you need a license to obtain poisons?

A

To purchase regulated poisons or explosive precursors for home use, to purchase certification and ID is required

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73
Q

What license is required to obtain regulated poisons? How is this obtained?

A

An EPP licence from the home office, application requires ID, proof of address, certificate of good standing and a doctor’s report

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74
Q

Give examples of regulated explosive precursors.

A

Hydrogen peroxide, potassium/sodium chlorates, nitric acid

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75
Q

Give examples of reportable explosive precursors.

A

Sulphuric acid, acetone, nitrates

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76
Q

Give examples of regulated poisons.

A

Hydrogen cyanide, lead acetates, barium salts

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77
Q

Give examples of reportable poisons.

A

Ammonia, hydrogen chloride, phenols

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78
Q

What are the special requirements for storage of chemicals and poisons?

A

Should be stored in a cupboard or drawer solely dedicated to chemicals, not accessible to the public and no food should be stored below

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79
Q

Define denatured alcohol.

A

Made unsuitable for drinking by the addition of denaturants, methylated spirits

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80
Q

What are the two pieces of legislation controlling denatured alcohol?

A

Alcoholic liquor duties act 1979

Denatured alcohol regulation 2005

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81
Q

Define alcohol (spirit).

A

Alcohol of any description, including liquor mixed with alcohol, and all mixtures, compounds and products made with alcohol.

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82
Q

When can intoxicating liquor be sold?

A

Only by a person holding a justice’s license

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83
Q

What are the three types of denatured alcohol?

A

Completely
Industrial
Trade specific

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84
Q

What are the features of completely denatured alcohol?

A

Mineralised methylated spirits, no supply of usage limits/regultions
Per every 100 parts volume, 3 parts methylethylketone, 1 gramme denatonium beznoate
May contain methyl violet as dye

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85
Q

What are the features of industrial denatured alcohol?

A

95% alcohol

5% wood naphtha

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86
Q

What is trade specific denatured alcohol?

A

Approved to meet trade specific needs, 11 approved formulations

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87
Q

How can pharmacists obtain industrial denatured alcohol?

A

Written authorisation required from revenue and customs which is valid indefinitely. States what they can receive and its purpose of use, may specify storage conditions

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88
Q

Can pharmacists trade industrial denatured alcohol between each other if they both hold authorisation to obtain?

A

Yes, in quantities below 20L

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89
Q

What are the conditions of supply of denatured alcohol for medical use?

A

Prescriptions may be dispensed as normal
Written orders from practitioners has no quantity limit but the classification and quantity must be provided
Patients/prescribers do not require authorisation

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90
Q

What is surgical spirit?

A

89-85% ethanol
1-5% methanol
No direct controls but must be labelled for external use only

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91
Q

What are the features of duty free spirits?

A

Records should be kept in stock book

Can have medical use

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92
Q

What is isopropyl alcohol?

A

Usually 70%

No specific requirements

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93
Q

What are the two pieces of legislation that control veterinary medicines?

A

Veterinary Medicines Regulation 2013

Misuse of Drugs Act 1971

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94
Q

What are the two regulatory bodies of veterinary medicines?

A

Veterinary medicines directorate

National office of animal health

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95
Q

Define veterinary medicinal product.

A

Any substance presented to have properties for treating or preventing disease in animals with marketing authorisation

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96
Q

What is a POM-VPS?

A

Prescription only medicine that can be supplied by veterinarian, pharmacist or suitably qualified person

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97
Q

What is an NFA-VPS?

A

Veterinary P product for non-food producing animals

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98
Q

What is an AVM-GSL?

A

Authorised veterinary medicine for general sale

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99
Q

Under what circumstances does a vet not need to be present for handover of medicine against their prescription?

A

If each individual transaction is authorised before supply or they are satisfied that the person who is handing over is competent

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100
Q

What is an SQP in terms of veterinary medicines?

A

An animal medicine advisor who has passed the appropriate examinations to prescribe

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101
Q

What are the features of POM-V medicines?

A

Strcit limitations of use for safety reasons
Narrow safety window
Require specialist vet knowledge
Clinical assessment of animal must occur for prescription to be given
Only the minimum amount necessary for treatment should be supplied

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102
Q

What are the features of POM-VPS medicines?

A

Used to reduce/prevent effects of endemic disease in herds
Use implies risk to target species or user
Simple advice should be given along side supply
Professionals may receive adequate training for administration

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103
Q

What are the overlapping features of POM-V and POM-VPS?

A

For food producing animals
Special precautions taken to avoid unnecessary risk
May interfere with future diagnosis
Include new VMPs

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104
Q

What are the features of AVM-GSL?

A

Wide safety margin
Treatment for common ailments
No specialist advice

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105
Q

What is the exemption for small pet animals?

A

Permits certain medicines to be placed on the market in any retailer without MA subject to conditions

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106
Q

What animals come under the exemption for small pets?

A 
Aquarium animals
Cage birds
Homing pigeons
Terrarium animals
Small rodents
Ferrets
Rabbits
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107
Q

What must be determined by an RQP before the supply of a veterinary prescription/medicine?

A

Recipient is competent in the use of the product for authorised purpose
Advise on safe administration
Provide warnings
Give minimum quantity necessary for treatment

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108
Q

What are the record requirements for POM-V and POM-VPS?

A 
Name of medicine
Date of receipt/supply
Batch number
Quantity
Name and address of Rx-er
Name and address of recipient
Copy of Rx if possible
Retain for 5 years
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109
Q

How long are veterinary prescriptions valid for?

A

6 months, unless a shorter time is indicated by the prescriber
28 days for schedule 2 and 3

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110
Q

What are the requirements of a veterinary prescription?

A 
Name, address, telephone and qualification of Rx-er
Signature
Name and address of owner
Species, identification and address of animal
Date
Name and amount of medicine
Dosage/administration instructions
Warnings/withdrawal periods
Number of repeats where necessary
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111
Q

What are the additional prescription requirements for veterinary CD schedule 2 and 3?

A

RCVS number of prescriber

‘Item prescribed for animal/herd under the care of a veterinarian’

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112
Q

What are the requirements for an EEA veterinarian prescriber?

A

Must be registered with RCVS

Must have carried out a clinical assessment on the animal

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113
Q

What is the additional requirement for a veterinary prescription under the veterinary cascade?

A

‘Prescribed under the cascade’

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114
Q

What are the requirements for manufacturer labelling of veterinary medicines?

A 
Must be in English
UK authorised veterinary medicinal product stamp
Name, strength, form
Name/proportion of active ingredients and any excipients mentioned in MA
Route of administration
Batch number
Expiry date
'For animal treatment only'
'To be supplied on veterinary Rx'
Contents by weight, volume or dosage unites
MA number and holder details
Labelled space for discard date
Target species
'Keep out of reach and sight of children'
Distribution category
Storage instructions
In use shelf life
Withdrawal period for food producing species (even if zero)
Warnings specified in MA
Disposal advice
Full indications
Dosage instructions
Contraindications
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115
Q

What are the label requirements for POM-V?

A 
Name, address of owner and supplier
Date of supply
Name, strength and quantity
Dosage and directions for use
'For animal use only'
'For external use only'
116
Q

What are the stages of the veterinary cascade?

A

1- VMP authorised in the UK for another animal species OR another condition in the same species
2- UK medicinal product for human use OR VMP authorised in another EU country for use with any animal species
3- medicine prepared extemporaneously as prescribed

117
Q

What is the veterinary cascade?

A

Used to find an alternative where there is no suitable authorised VMP in the UK

118
Q

Which persons can supply under the veterinary cascade?

A

Veterinarians and pharmacists may supply any medicine supplied under the cascade
SQPs may dispense any authorised VMPs prescribed

119
Q

What is a schedule 1 controlled drug?

A

Licensed POM

120
Q

What are the requirements of CD schedule 1 drugs?

A

No therapeutic use, limited to research etc

License required from the home office to produce/possess/supply

121
Q

Under what circumstances may a pharmacist possess a schedule 1 CD?

A

For destruction or police handover

122
Q

Give examples of schedule 1 CDs?

A

LSD
Ecstasy
Raw opium
Cannabis

123
Q

What is a schedule 2 controlled drug?

A

Register POM

124
Q

What are the requirements of CD schedule 2 drugs?

A

License required for import/export
Pharmacy controls over destruction, container marking, record keeping and safe custody including expired and returned meds
Private prescriptions written on a standard form

125
Q

What is the exception for safety custody of CD schedule 2?

A

Quinalbarbitone

126
Q

Give examples of schedule 2 CDs?

A 
Cocaine
Methadone
Morphine
Ketamine
Opiates
127
Q

What is a schedule 3 controlled drug?

A

No register POM

128
Q

What are the requirements for schedule 3 controlled drugs?

A

No register or destruction requirements

Invoice must be retained for two years

129
Q

Which schedule 3 drugs to safe custody rules apply to?

A

Diethylpropion
Temazepam
Buprenorphine
Flunitrazepam

130
Q

Give examples of schedule 3 CDs?

A

Barbituates
Midazolam
Tramadol

131
Q

What are schedule 4 part I CDs?

132
Q

What are schedule 4 part II CDs?

133
Q

What are the requirements for schedule 4 controlled drugs?

A

No register, safe custody or destruction requirements
Home office license for import/export
Emergency supplies permitted
No restriction on possession of part II

134
Q

Give examples of schedule 4 CDs?

A

Part I- benzodiazepines, cannbinoids

Part II- anabolic/androgenic steroids, growth hormones

135
Q

What are schedule 5 CDs?

A

Invoice POM/P

136
Q

What are the requirements for schedule 5 controlled drugs?

A

Negligible potential to supply or for misuse
Invoices retained for 2 years
Exempt from other controls

137
Q

Give examples of schedule 5 CDs?

A

Codeine
Pholcodeine
Morphine present at low strengths

138
Q

Are legal highs banned?

A

Yes for import, manufacture, distribute and supply

139
Q

What is Sativex?

A

Schedule 4 CD derived from whole plant extracts of cannabis

Destruction requirements apply to importers, exporters and manufacturers

140
Q

When is it lawful to possess/supply CDs?

A

Prescribed for person (or animal)
Have appropriate Home Office license
Person specified in regulations as acting in their capacity (constable, postal worker, customs officer)

141
Q

Who is specified in law to possess CDs?

A 
Doctors, dentists, pharmacists, independent prescribers
Senior registered nurse on a ward
Person in charge of laboratory
Public analyst, sampling officer
Master of a ship with no doctor on board
Ambulance trusts
142
Q

What are the requirements for taking CDs abroad?

A

No personal license required by the home office for less than 3 months supply
Patient advised to obtain covering letter from prescriber, check with embassy and travel operators before travel

143
Q

When do CD requisitons/prescriptions not need to be sent to the NHSBSA? What is their fate?

A 
Veterinary prescriptions- retained for 5 years
Hospital/care home- retain for 2 years
Manufacturer/wholesale
Prison pharmacy to prison wings
Midwife supply order- retain for 2 years
144
Q

What CDs can a midwife obtain on a supply order?

A

Diamorphine
Morphine
Pethidine

145
Q

How many days treatment can be given on a CD instalment?

146
Q

What drugs are given on a CD instalment?

A

Schedule 2 drugs
Buprenorphine
Diazepam

147
Q

When must the first instalment be dispensed on an FP10MDA prescription?

A

Within 28 days of date on Rx or date expressly specified

148
Q

What is contained within an instalment direction?

A

Amount per instalment
Interval between instalments
Dose and instalment amount must be specified separately

149
Q

What exemptions may be included in an instalment direction?

A

Dispense instalments due on pharmacy closed days on prior suitable days
If a day is missed, dispense the amount due for remaining days
Contact Rx-er if 3 or more consecutive days are missed

150
Q

Who may prescribe treatment for addicts? What treatment does this include?

A

Prescribers specifically authorised by the secretary of state
Cocaine, diamorphine, dipipanone

151
Q

What is the protocol for collection of CDs?

A

Supply to patient or representative and request of ID is at the pharmacist’s discretion
HCP collecting on behalf of patient must provide ID, name and address

152
Q

What is the protocol for collection of drug misuse CDs?

A

Representative must have a letter of authorisation from the patient for each time they collect
Rx-er must be contacted if this is a supervised dose

153
Q

What CDs may a nurse or pharmacist supply against a PGD?

A

For necessary immediate treatment of a sick patient they may supply diamorphine or morphine

154
Q

What CDs may a nurse or pharmacist supply in addiction?

A

Schedule 5 or 4 part I
Midazolam
Not parenteral

155
Q

What are the requirements of emergency supplies of CDs?

A

Phenobarbitone or schedule 4/5 are permitted at the request of a prescriber
Up to 5 days treatment with schedule 4/5 at patient request

156
Q

Where does safe custody apply to CDs?

A

Retail dealers
Care homes
Private hospitals

157
Q

What are the requirements of CD containers?

A

Should be plainly marked with the amount of drug

With preparations, with the amount per dosage unit and number of dosage units

158
Q

How long should a CD register be kept for?

A

2 years from its last entry

159
Q

What are the requirements for destruction of schedule 2 CDs?

A

Must have an authorised witness present, not necessary for patient returns

160
Q

What is a CD accountable officer?

A

Some appointed by a designated body who does not routinely supply/handle CDs

161
Q

Who may act as an authorised witness?

A 
Constable
GPhC inspector
Senior staff
Suitably trained employees
Controlled drug liaison officer
162
Q

What legislation accounts for patient returned CDs?

A

Hazardous Waste Regulations 2005

163
Q

What are P medicines?

A

Available in registered pharmacies without prescription under the supervision of a pharmacist
Listed in HMR 2012 Schedule 1 part 2

164
Q

What products are included in the P medicine category?

A

Anthelmintics
Parenterals
Enemas and irrigation
Aspirin in under 16s
POM under certain conditions of marketing authorisation
GSL above certain quantities
Covered by exemptions from licensing from pharmacists

165
Q

What medicines are included in HMR 2012 schedule 1 part 1?

A 
Parenterals
CDs
Cyanogenics
Those that emit radiation
Restrictions of aloxiprin, aspirin, paracetamol, pseudoephedrine salts
166
Q

Which controlled drugs are exempt from POM status?

A 
Those containing one of the following substances in a specified form and at a max strength
Dihydrocodeine
Ethylmorphine
Pholcodeine
Codeine
Morphine
Any of their salts
167
Q

What are counter prescribed medicines?

A

Can be made up by a pharmacist if deemed appropriate consisting of either GSL or P medicines

168
Q

What are the restrictions on pseudoephedrine and ephedrine products?

A

Unlawful to sell these products together where they contain more than 720mg of pseudoephedrine salt or 180mg of ephedrine

169
Q

What are the main professional problems presenting with sale of P medicines?

A

Emergency oral contraception
Codeine/dihydrocodeine should not be used for more than 3 days, max supply of 32
Cough medicines unsuitable for children contains pholcodine, dextromethorpran, guaifenesin, ephedrine
OTC codeine liquid not for use in under 18s

170
Q

What are GSL medicines?

A

Not classified as P or POM but have marketing authorisation. May be sold with reasonable safety without supervision of a pharmacist

171
Q

Give an example of a medicine available as POM, P and GSL?

A

Quinine
P with a max daily dose of 300mg
GSL in its base form with a max daily dose of 35mg

172
Q

When can retail shops sell GSL?

A

Where they can be closed to exclude the public
The product was made elsewhere and remains in its original packaging
Follow schedule 15 requirements

173
Q

What are the exemptions for general conditions of sale/supply of GSL?

A

Doctor/dentist to a patient under their care
Registered midwife in the course of their practice
Hospitals/healthcare centres

174
Q

What are the common pack size limits in GSL medicines?

A

Paracetamol and aspirin up to 500mg in packs of 16
Aspirin, aloxiprin and paracetamol effervescent up to 30
EC aspirin 75mg in packs of 28
Ibuprofen in packs of 16 or 12 granules/powder sachets

175
Q

What are the requirements for a product to be moved from a POM to a P classification?

A

No longer presents danger to health
Not frequently used incorrectly
Activity/side effects require no further investigation
Not usually prescribed by doctor as a parenteral

176
Q

What are PO medicines?

A

Not a legal classification in HMR 2012

GSL products whose sale is restricted to pharmacies, RP does not need to be present

177
Q

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

A

Prescriber is appropriate
There is a genuine emergency
Rx to be provided within 72 hours
Supply made in accordance with instructions
CD 4 and phenobarbital are permitted from UK prescriber
Record may on the day or day following

178
Q

What are the record requirements for an emergency supply?

A 
Medicine supplied, all details including quantity
Name/address of Rxer
Name/address of patient
Date on which POM is sold
Date on Rx
Date Rx received by pharmacy
Reason for supply
Reference number
179
Q

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

A

Immediate need
Treatment has previously been received on Rx
Dose appropriated
Patient has been interviewed
Treatment does not exceed 30 days (5 days for phenobarbital and Sch 4/5)

180
Q

What POMs cannot be given in an emergency supply at patient’s request?

A 
Bromide salts
Hexobarbitone
Methohexitone
Strychnine
Thiopentone
181
Q

What may be given in emergency supply at patient’s request where treatment exceeds 30 days?

A

Inhalers
Creams
Insulin
Where smallest pack size exceeds 30 days

182
Q

Which POMs may be administered by anyone for the purpose of life saving?

A 
Adrenaline 1mg/ml
Atropine sulphate
Chlorphenamine
Dicobalt edetate
Glucagon
Glucose 50%
Hydrocortisone
Naloxone
Pralidoxime
Antiserum (venom)
Sodium nitrite
183
Q

What are the requirements of a PGD?

A 
Doctor/dentists signature
Pharmacist signature
Name of business that owns it
Description of medicines
Start/end dates
Health professionals able to administer
Signature by appropriate organisation
Clinical situation where it applies
Details of dosage, form, quantity and regimen
Warnings
Follow up actions
Records
184
Q

What medication requires guidance or is not permitted on a PGD?

A

Antimicrobials to be used with caution
Black triangle drugs included in exceptional circumstances
Unlicensed drugs not permitted
No anabolic steroids
No midazolam from schedule 3
Schedule 2 morphine and diamorphine excluded for addiction

185
Q

Under what circumstances is it permissible to supply others with ‘wholesale’ medicines without a wholesale license?

A

Supply to HCPs to hold for local provision or to other pharmacies to meet the needs of individuals where this happens only on occasion and in small quantities on a non-profit basis where the medicines are not for onward wholesale distribution

186
Q

Where can you find the list of persons eligible to receive wholesale medicines?

A

Listed in HMR 2012, schedules 17 and 22

187
Q

What medicines may a midwife sell/supply in their capacity?

A

GSL and P medicines

POM medicines containing diclofenac, hydrocortisone, miconazole, nystatin or phytomenadione

188
Q

What medicines may a midwife administer parenterally in their capacity?

A

Adrenaline, anti-D immunoglobulin, cyclizine, diamorphine, ergometrine, hep B vaccine, lignocaine, naloxone, oxytocin, pethidine, prochlorperazine, NaCl

189
Q

What POM medicines may optometrists supply in their capacity?

A 
Chloramphenicol eye drops <0.5%
Chloramphenicol eye ointment <1%
Cyclopentate
Fusidic acid
Tropicamide
190
Q

What POM medicines may optometrists obtain in their capacity for clinical use?

A

Amethocaine
Lignocaine
Oxybuprocaine

191
Q

What POM medicines may additional supply optometrists supply in emergencies?

A

Diclofenac

Polymixin B

192
Q

What P medicines may chiropodists supply in their capacity?

A 
Potassium permanganate crystals
Ibuprofen
Heparinoid ointments
Clotrimazole 1%
Crobamiton 10%
Griseofulvin 1%
Miconazole 2%
Salicylic acid 70%
Terbinafine 1%
193
Q

What medicines may POM chiropodists supply in their capacity?

A 
Amoxicillin
Erythromycin
Flucloxacillin
Co-codamol
Co-dydramol
Codeine
Amorolfine
Hydrocortisone 1%
194
Q

What medicines may local anaesthetic chiropodists give parenterally in their capacity?

A

Adrenaline
Lignocaine
Prilocaine
Methylprednisolone

195
Q

What medicines may paramedics administer to patients requiring immediate treatment?

A 
Diazepam 5mg/ml
Succinylated gelatin 4% infusion
Adrenaline
Amiodarone
Anhydrous glucose
Ergometrine
Furosemide
Heparin (cannula flushing)
<20mg morphine
Metoclopramide
Naloxone
Streptokinase
NaCl
196
Q

Define criminal law.

A

Relationship between an individual and the state, regulating human behaviour

197
Q

Define civil law.

A

Relationship between individuals relating to the conduct of human relations
Compensation may be awarded to the victim

198
Q

What is penal law?

A

Conditions of bodies of rules with potential for severe punishment, actions considered harmful to society as a whole

199
Q

What is primary legislation?

A

An act of parliament laying down general principles

200
Q

What is secondary legislation?

A

An act delegates power to other bodies by making detailed rules

201
Q

What are statutory instruments?

A

Concerned with working detail, referring back to an act

Including regulations and orders

202
Q

What is the process of enactment? (6 stages)

A

1- green paper for discussion
2- white paper, signal of intention
3- proposals set for other parties to give input
4- bill, proposes introduction of new legislation
5- debate in both Lords and Commons
6- formal enactment, royal assent received

203
Q

What is judicial precedent?

A

Common law
A statement of the legal position in a particular case/situation based on decisions of previous courts in similar situations

204
Q

Under what circumstances does a judge make the law?

A

Where there is no legislation on a particular situation or the available legislation has a meaning that is unclear

205
Q

Describe the features of the Medicines Act, including date published.

A

1968
Controls medicinal products at all stages
Over 200 statutory instruments

206
Q

Describe the features of the Misuse of Drugs Act, including date published.

A

1971
Controls medicines that are misused
Regulations published 2001

207
Q

Describe the features of the Poisons Act, including date published.

A

1972
Controls poisons
Amended by deregulation act of 2015

208
Q

Describe the features of the second Health Act, including date published.

A

2006

Supervision and management of controlled drugs

209
Q

Describe the features of the first Health Act, including date published.

A

1999
Amended by health and social care act of 2008
GPhC control of pharmacists 2010

210
Q

Describe the features of the Human Medicines Regulation, including date published.

A

2012

Divided into 17 schedules covering everything relating to human medicines

211
Q

What constitutes as medicinal purpose?

A 
Treating/preventing disease
Diagnosing disease
Contraception
Inducing anaesthesia
Otherwise preventing/interfering with normal operation of physiological function
212
Q

What is the protocol for dental prescribing?

A

Medicines act permits dentists to prescribe anything in the BNF
GDC recommends that they prescribe drugs in their area of competency
NHS limits them to DPF

213
Q

What are the main considerations for forgery of prescriptions?

A 
Excessive quantity
Appropriateness for patient/condition
Known Rx-er
Known patient
Title 'Dr' present in signature
Patient behaviour
Commonly misused medicine
214
Q

Are CD Schedule 2 and 3 drugs valid on an EPS?

A

Yes as of 2015

215
Q

What is the protocol for prescribing/supply in hospitals?

A

Maybe supplied against kardex providing written direction to supply is patient specific and given by appropriate practitioner

216
Q

When don’t POM records apply?

A

NHS prescriptions
Oral contraceptives
Separate record kept, such as CD
Sale is by way of wholesale deal, invoice kept for 2 years

217
Q

What are the legal requirements for a dispensing label?

A 
Patient name
Name/address of pharmacy
Dispensing date
Medicine name etc
Directions for use
Precautions relating to use of product
'Keep out of reach and sight of children'
218
Q

What are the additional legal requirements of a CD prescription?

A 
Clearly defined dose, not mud or prn
Formulation
Strength where more than one exists
Total quantity in words and figures, should not exceed 30 days
'For dental treatment only'
219
Q

When should a CD be dispensed? Including repeatable prescriptions.

A

Within 28 days if Sch 2 or 3
Sch 4 first repeat must be within 28 days
Schedule 5 first repeat within 6 months

220
Q

What is a POM?

A

Medicinal products which may only be sold/supplied by retail in accordance with a prescription given by an appropriate prescriber

221
Q

Give common reasons for POM classification.

A

Required medical supervision to prevent damage to human health
Wide/frequent misuse
New active substance
Parenteral administration

222
Q

What are the prescribing restrictions of an optometrist?

A

No parenterals or CDs

223
Q

What are the prescribing restrictions of a chiropodist?

A

No CDs other than oral diazepam, oral dihydrocodeine, fentanyl patches, oral lorazepam

224
Q

What are the prescribing restrictions of a physiotherapist?

A

No CDs other than diazepam, dihydrocodeine, fentanyl, temazepam, lorazepam, morphine, oxycodone

225
Q

What is supplementary prescribing?

A

Voluntary prescribing partnership between an independent and supplementary prescriber to implement a care plan

226
Q

What must a written clinical care plan include?

A 
Specific named patient
Illness/conditions treated by SP
Date of start and review
Reference to description of medicinal products
Restrictions (dose etc)
Warnings
Arrangements in case of suspected ADRs
When to seek advice from IP
227
Q

What are the legal requirements for a prescription?

A 
Signature
Appropriate Rx-er address
Date
Rx-er type
Patient name and address
Age if under 12
228
Q

What are the additional legal requirements for a prescription from an EEA HCP?

A

Date of birth
Rx-er qualifications
Direct contact details for Rx-er
Appropriate translation

229
Q

Define supervision.

A

Linked to personal control, physical presence in the pharmacy

230
Q

What regulations does the Health Act 2006 set out for the responsible pharmacist?

A

Statutory duty to secure safe and effective running, allows ministers to produce regulations covering the ability of an RP to be absent

231
Q

What is a superintendent pharmacist?

A

Required where a pharmacy is carried by a corporate body, any RP remains subject to SI direction

232
Q

What is required on an RP notice?

A

Name of RP
GPhC number
State that they are in charge of the pharmacy at that time

233
Q

What records are required to be filled out daily by the RP?

A

Name and reg number
Date/time start and end of their role as RP
Continuous daily record
Absence details, with reason

234
Q

Under what circumstances may an RP be absent?

A

For a maximum of 2 hours in 24 hours

Should remain contactable and able to return with reasonable promptness

235
Q

What cannot occur in the absence of an RP? (5 things)

A 
Professional check of Rx
Sale/supply of P medicines
Sale/supply of POM, including handover of prescription items
Supply under a PGD
Emergency supply
236
Q

What is professional supervision?

A

Supervision by a suitable qualified person other than the RP

237
Q

What may occur in the absence of the RP, under professional supervision? (5 things)

A 
Generation of dispensing label
Taking medicines off shelves
Assembly of items
Labelling containers
Accuracy check
238
Q

What can occur in the absence of the RP? (6 things)

A 
Ordering stock from wholesaler
Receiving stock (exc. CDs)
Date checking (exc. CDs)
Accessing PMR
Receiving prescriptions
Delivery person handing over medication to patient
239
Q

What may occur within a pharmacy without supervision? (2 things)

A

Sale of GSL medicines

Processing waste and patient returns (exc. CDs)

240
Q

Define a retail pharmacy business?

A

Business that consists of or includes the retail sale of medicinal products that are not subject to general sale

241
Q

Who may lawfully conduct a retail pharmacy business?

A 
Individual pharmacist or partnership (do not all have to be pharmacists in Scotland)
Body corporate (must be under SI management)
Representative incase of death, illness or bankruptcy
242
Q

What are the conditions of conducting a retail pharmacy business as a representative?

A

Must notify GPhC of their name and address
May act for 3 years in case of illness, disability or bankruptcy
May act for 5 years in case of death

243
Q

What are the requirements for being an SI pharmacist?

A

Must be a pharmacist
Statement in writing sent to registrar signed by them and the body corporate
Must not act in a similar capacity for any other body corporate
May act as RP
Must be appointed to manage pharmaceutical aspects of business

244
Q

What are the 4 types of GPhC membership?

A

Member
Fellow
Associate
Student

245
Q

What does the GPhC represent?

A

Best interests of the patient

246
Q

What does the RPS represent?

A

Interests of pharmacists

247
Q

What does the GPhC regulate?

A

Pharmacists
Pharmacy technicians
Premises

248
Q

What are the principal functions of the GPhC?

A

Establish and maintain register
Promote standards for safety and effective practices
Fitness to Practice requirements
Standards relating to education, training, CPD and experience

249
Q

What is the basic structure of the GPhC?

A

14 members, 7 lay members and 7 registrant members
Appointed by a committee
At least one member from each GB country
Registrar appointed by committee, may appoint a deputy

250
Q

What are the 5 parts of the GPhC register?

A 
Pharmacists (protected title)
Pharmacy technicians (protected title)
Premises
Pharmacists visiting as a practitioner
Pharmacy technicians visiting as a practitioner
251
Q

What are the criteria for entitlement to the register?

A

Appropriate qualification
Fitness to practice
Prescribed fee paid
Intend to practice in GB, channel island or the isle of man

252
Q

What constitutes the appropriate qualification for entry to the GPhC register?

A

UK MPharm, pre-registration year and exam
EEA equivalent
Overseas qualification, OSPAP course and pre-registration year

253
Q

What personal information is held on the GPhC register?

A 
Full name
Postal town
Annotations
Registration number
FtP issues
254
Q

What premises information is held on the GPhC register?

A 
Trading name
Owner
Address
Subject to conditions
Internet logo
Registration number
255
Q

What is required for an application to the GPhC?

A 
Form
Copy of degree
Certified copies of birth certificate, marriage certificate, proof of identity
Final declaration from tutor
Letter of good standing
Certified photograph
256
Q

What annotations may be included in a GPhC register entry?

A

Additional qualifications
SI
Supplementary/independent prescriber

257
Q

When may temporary access to the GPhC register be granted?

A

In the case of emergencies, loss of life or health epidemics

258
Q

What education facilities may be accredited by the GPhC?

A 
Training/education courses
Qualifications granted upon successful examination
Institutions 
Tutors
Premises
259
Q

What are the English language requirements for entry to the GPhC register?

A

Health Care and Associated Professions order 2015 makes it a legal requirement for all registrant to have necessary knowledge of English

260
Q

What governance arrangements are set out in GPhC principles for registered pharmacies 2012?

A

Safeguarding health, safety and wellbeing of patients
Clear definitions of accountability and risk management
Staff are empowered and competent
Environment and conditions
Delivery of pharmacy services
Equipment and facilities

261
Q

Define traditional pharmacy service.

A

All parts of pharmacy service take place in the same registered premises

262
Q

Define distance pharmacy service.

A

Any activities being carried out at different registered pharmacies or locations
Or where the member of staff and person using the same service are not both in the same registered pharmacy together

263
Q

What is the GPhC inspectorate?

A

Made up of 38 inspectors across GB

Proactively assess premises routinely every 5 years

264
Q

What is the role of the GPhC inspectors?

A

Enforce standards
Securing compliance with the law
Enforce article 38 regarding offences relating to the register
Assist council in FtP matters

265
Q

What is the power of entry of GPhC inspectors?

A

Able to enter any registered premises at any reasonable hour
Must provide identity and authorisation
Not obliged to notify prior to visit

266
Q

What is an improvement notice served by GPhC inspectorate?

A

Served to SI and RP
State grounds for belief of failure in complicance
Specify measures to rectify failures
State right of appeal

267
Q

What occurs in the case of non compliance with an improvement notice served by GPhC inspectorate?

A

Results in a fine
Inspector must notify registrar in writing
May suspend or remove the premises from the register

268
Q

What is fitness to practice?

A

Annual declaration of competence submitted with 4 CPD records

269
Q

What constitutes impairment of FtP?

A 
Misconduct towards a patient/customer
Deficient professional performance
Adverse health
Failure to comply with requirement imposed by assessor
Conviction of criminal offence
Fixed penalty
Police caution
Inclusion in barred list
270
Q

Under what circumstances may the registrar refer an FtP case to the investigating committee?

A

Where evidence suggests:
Conduct presents risk, undermines confidence in pharmacy professionals, serious failure to meet standards
Honesty/integrity can no longer be relied upon
It is in public interest

271
Q

What may an FtP investigation involve?

A 
Speaking to complainant and witnesses
Speaking to pharmacist
Visiting location of alleged incident
Collect witness statements
Formally interview employees, owners and pharmacist
Seize evidence
272
Q

What is the role of the investigating committee?

A

Screening cases before referral to FtP committee

Do not hear oral evidence, may give warning to appear in register

273
Q

What is the role of the FtP committee?

A

Consider all referred cases to determine if impairment is present

274
Q

What sanctions may the FtP committee impose?

A 
Give advice
Issue a warning
Impose conditions to register entry for up to 3 years
Suspend for up to 12 months
Remove from register
275
Q

What are the criteria for FtP suspensions?

A

Following review, the suspension may be extended for a further 12 months or the entry may be removed completely
May suspend indefinitely where it has been in place for over 2 years
On termination of suspension, conditions may be imposed for 3 years

276
Q

Under what circumstances may entries not be removed from the register regarding FtP?

A

Where it is impaired by ill health alone

277
Q

What occurs after referral to FtP committee?

A

Registrant must supply details of their employer within 14 days
Employer must be notified of the referral
Professional performance assessor may demand records within 14 days or seek a court order

278
Q

What is an interim order?

A

Imposed when the FtP committee feel that it is in the best interests of the public or the registrant
May be suspension for up to 18 months or conditional re-entry
Reviewed every 6 months or where new evidence is available

279
Q

What are the conditions or restoration or reapplication to the register?

A

Application cannot be made for 5 years after removal or within 12 months of another application
Restoration may be conditional for up to 3 years
FtP committee can direct that no further applications can be made

280
Q

What directions from the FtP committee may be appealed

A

Direction to remove entry
Direction fro suspension or conditional entry
Direction to alter conditions
Direction to prevent further applications

281
Q

What are the possible outcomes of an appeal against an FtP direction?

A

Dismissal
Allow appeal and quash direction
Substitute for alternative direction FtP committee could have given
Referral

282
Q

When does FtP committee direction take effect?

A

After period of appeal or appeal itself is complete

May be sooner or immediately where to committee deem necessary to protect public safety

283
Q

What is a coroner?

A

Independent offices of the crown
Usually a doctor or solicitor
Appointed by local councils
Investigate deaths that are unnatural or unexpected

284
Q

What deaths are reported/investigated by a coroner?

A

Deceased not seen by a doctor during final illness
No death certificate available
Death certificate cannot be signed by a doctor within 14 days
Death during surgery or before anaesthetic wears off
Death from industrial disease or poisoning
Sudden, unexplained
Violent or due to neglect
Suspicious
In police custody or prison

285
Q

What is a rule 43 report?

A

Formal letter issued by a coroner to interested parties in order to prevent future deaths
Must be responded to in writing and acted upon

286
Q

What is the Bolam/Bolitho test?

A

Used to assess medical negligence against what other people would do
Cannot defend case on the basis of current practice that is not legal or reasonable

Pharm Y2S2 (26 decks)

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