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Pharmacy Year 2 > Law - Semester 2 > Flashcards

Law - Semester 2 Flashcards

1
Q

Which regulations determine licensing requirements?

A

HMR

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2
Q

Which aspects of medicines does licensing affect?

A

Manufacture
Sale
Supply
Importation

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3
Q

Which bodies can provide licensing for medicines?

A

Medicines and Healthcare products Regulatory Agency (MHRA)

European Medicines Agency (EMA)

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4
Q

What are the objectives of legislation surrounding licensing?

A
  • Efficacy, safety and quality of medicinal product

- Withdrawal of the product should any danger be discovered

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5
Q

What medicinal products are covered by licensing legislation?

A
  • Authorised medicinal product

- Investigation medicinal products

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6
Q

Which stages does licensing legislation cover?

A

Initial development and research through to final marketing

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7
Q

What are the different types of licenses or certificates?

A 
Marketing authorisation
Certificate of registration
Traditional herbal registration
Manufacturer's license
Wholesale dealers license
Clinical trial authorisation
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8
Q

Describe the three stages of clinical trials

A
  • Drug given to small groups - Evaluating safety, therapeutic range and side effects
  • Drug given to a larger group - Testing efficacy and safety
  • Drug given to even larger group - Increased safety, confirm efficacy, monitor side effects. Compare to other common treatments
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9
Q

What is a marketing authorisation and who must have one?

A
  • Allows the sale, supply, import and export of a relevant medicinal product
  • Must be held by the person in charge of the product manufacture
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10
Q

What must an application for a marketing authorisation contain?

A
  • Name and address of applicant (and manufacturer)
  • Name of product and specification
  • Evaluation of environmental risks
  • Method of manufacture and quality control
  • Indications, contraindications, compatibility and clinical studies data
  • Pharmacovigilance system
  • Product characteristics, package and leaflet
  • Proposed legal category
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11
Q

What type of products may require application for a marketing authorisation?

A
  • New active substances
  • Generic medicinal products
  • Biological/Biotechnology products
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12
Q

What is important for a marketing authorisation to be granted?

A
  • Product determined safe and effective

- Manufacturing/quality control facilities must be adequate

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13
Q

How long is an initial marketing authorisation valid for?

A

5 years

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14
Q

What should be continuously relayed to the licensing authority for renewal of a marketing authorisation?

A

Changes to products and procedures

Any new information

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15
Q

What records must a marketing authorisation holder have?

A
  • Adverse reports
  • Sales and supplies
  • Sources of materials
  • Any document that will support product withdrawal
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16
Q

What must a marketing authorisation holder produce regarding safety?

A

Periodic safety update report

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17
Q

When may a product name be rejected by the MHRA?

A

if name is misleading, could cause confusion or is generally unsafe

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18
Q

In what patient group are unlicensed medicines used and why?

A

Children - medicinal products generally only have clinical trials in adults due to ethical issues

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19
Q

How do clinical trials for paediatric medicines differ to adult clinical trials?

A

Clinical trials for every age group within paeds

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20
Q

What are the EU regulations to increase availability of medicines for paeds?

A
  • Paediatric investigation plan

- Paediatric use marketing authorisation

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21
Q

What legislation sets out the labelling requirements for relevant medicinal products?

A

HMR and Misuse of Drugs Regulations

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22
Q

What are the requirements for labelling medicinal products?

A
  • Easily legible and comprehensible
  • Indelible
  • English only or English PLUS other languages
  • Braille on outer packaging and PIL for blind patients
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23
Q

What are the outer and immediate packaging requirements?

A
  • Name, strength and formulation of medicinal product
  • Patient group intended
  • Name and amount of active substance
  • Pharmaceutical form by weight/volume/no. of doses
  • List of excipients that have an effect (all excipients if injectable, topical or eye prep)
  • Method and route of administration
  • Prescribed dose (if appropriate)
  • Children statement and cautionary warnings
  • Expiry date
  • Storage/disposal instructions
  • MA holder name and address, MA number
  • Batch no
  • Instruction for use
  • Classification
  • NO PROMOTIONAL STYLE INFO
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24
Q

What must a blister pack contain?

A
  • Name, strength and formulation of RMP
  • Who the product is for (if appropriate)
  • Name of active substance
  • Name of MA holder
  • Expiry date and batch no
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25
Q

What is the difference between the labelling of a small container and a blister pack?

A

All requirements of a blister pack but method of administration too

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26
Q

What are the labelling requirements for paracetamol?

A
  • ‘Contains paracetamol’ if name does not state this
  • ‘Do not take more than the label tells you to’
  • Direct patients to doctor in case of overdose
  • If consequences of overdose on PIL, does not need to be on outer packaging
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27
Q

Define manufacture

A

Any process carried out in the course of making the product

Not simply dissolving, dispersing, diluting or mixing the substance with a vehicle

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28
Q

Define assembly

A

Dividing up, packaging and presentation of the substance

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29
Q

What does a manufacturer’s license enable the holder to do?

A
  • Manufacture or assemble licensed medicinal products
  • Export product to countries outside the EEA
  • Import licensed products from outside the EEA
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30
Q

What must the licensing authority know before granting a license?

A
  • Operations to be carried out
  • Premises
  • Equipment available
  • Qualifications of supervisors
  • Safekeeping records
  • Maintenance of adequate records
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31
Q

Who must hold a marketing authorisation before its manufacture?

A

Manufacturer OR person ordering the product

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32
Q

What does a manufacturer ‘specials’ license allow the holder to do?

A
  • Manufacture of unlicensed medicines

- Import unlicensed products from outside the EEA

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33
Q

When is a ‘specials’ license not required?

A

If special product is being extemporaneously prepared in pharmacy

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34
Q

When are unlicensed products used?

A
  • When licensed products do not meet the patient’s clinical needs
  • Supplied according to unsolicited order from appropriate prescribers (for use by patient under their direct care)
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35
Q

What is a manufacturers license for investigational medicinal products?

A
  • Allows manufacture of IMPs for clinical trials

- For phase 1, 2 and 3 clinical trials

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36
Q

Define wholesale dealing

A

Supplied to someone before the medicine reaches the patient

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37
Q

What classifications can be sold with a wholesale dealers license?

A
  • Pharmacy
  • POM
  • Traditional herbal medicines
  • GSL medicines
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38
Q

What other action can be undertaken with a wholesale dealers license?

A

Import of unlicensed products from inside the EEA

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39
Q

Who can medicines be distributed to?

A
  • Wholesale dealer license holder (for those products)
  • Equivalent EEA wholesale license holder
  • Those who can lawfully sell or supply in retail sale
  • Those who can lawfully administer
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40
Q

What are the conditions of a wholesale license?

A
  • Staff, premises, equipment and facilities must be adequate for the handling, storage and distribution go medicinal products
  • Distribution records must be kept for at least 5 years
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41
Q

When are licenses not required?

A
  • If product prepared for an individual or for someone who holds relevant authorisations
  • If activity takes place in registered pharmacy under supervision of a pharmacist
  • If preparation and dispensing against a practitioner’s prescription or customer’s recipe/specification
  • Counter prescribing
  • Product assembly or stock mixtures
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42
Q

What are the conditions for own name products and is a license required to produce them?

A

No license - prepared under pharmacist supervision and not advertised to public

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43
Q

When are doctors and dentists exempt from licensing?

A

When preparing or assembling products on an individual patient basis

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44
Q

When are nurses and midwives exempt from licensing?

A

When assembling medicines for individual patients

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45
Q

What are the herbalist exemptions to licensing?

A

Products can be manufactured or assembled without a license or authorisation if:

  • Herbal practitioner is present and premises can be locked
  • Product is for administration to a person present at the time
  • Product does not contain specific listed substance
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46
Q

When do manufacturers/marketing authorisation holders not require a wholesale dealers license?

A

If marketing own product

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47
Q

When is a wholesale dealers license not required for importing a product?

A

If product is imported for a specific patient

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48
Q

When is a wholesale dealers license not required for exporting a product?

A

If product is being re-exported without making any alterations

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49
Q

When is a marketing authorisation required for food and cosmetics?

A

If promoting products to practitioners

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50
Q

When do food and cosmetics require appropriate licensing?

A

If administered orally for beneficial/medicinal purposes - has a stated dose

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51
Q

When do vitamins require licensing?

A
  • Oral administration with no dosage direction
  • If dose exceeds a specified amount
  • If foods with added vitamins exceed the daily range
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52
Q

Cosmetics containing what excipients must be appropriately licensed?

A
  • Antibiotics
  • 0.004% or more of a hormone
  • 0.1% or more of hexachlorophane
  • More than 1% resorcinol
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53
Q

What is a herbal medicinal product?

A

Products where the only active substances are herbal substances or preparations

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54
Q

Define ‘herbal substance’

A

A plant or part of a plant, fungi, lichen or algae or unprocessed exudate of a plant, defined by the plant part used and its biological name

Can be fresh or dried but otherwise unprocessed

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55
Q

Define ‘herbal preparation’

A

Herbal substance subjected to processes such as extraction, distillation, expression, fractionation, purification, concentration or fermentation

Contains a commented/powdered herbal substance, tincture, extract, essential oil, expressed juice or processed exudate

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56
Q

What are the types of herbal remedies and what licensing does each require?

A
  • Licensed herbal medicines (MA and relevant classifications)
  • Registered traditional herbal medicines (traditional herbal registration)
  • Unlicensed herbal products (individual production based on face-to-face consultation)
  • Food supplements or cosmetics (no licensing required)
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57
Q

Who are recognised suppliers of herbal remedies?

A
  • Pharmacists
  • Dealers - give product requested
  • Practitioners - Prescribe using specialist knowledge
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58
Q

When can practitioners deal in any herbs?

A

Following 1-1 consultation and if patient is present

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59
Q

When do HMR restrictions for sale and supply of herbal products not apply?

A
  • When product manufactured by herbalist practitioner on their premises (which can exclude public)
  • If product is for administration to a person who has requested it in person
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60
Q

What ingredients prohibit the manufacture, sale, supply and importation of unlicensed medicines?

A
  • Aristolochia

- Mu Tong

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61
Q

What ingredient prohibits the sale, supply and importation of products (unless for external use)?

A

Kava kava

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62
Q

What ingredient cannot be sold, supplied or imported?

A

Senecio

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63
Q

What are the restrictions of supply of herbal medicinal products by herbalists?

A
  • If plant listed in schedule 20 part 1: Can only be sold in registered pharmacy under the supervision of a pharmacist
  • If plant listed under schedule 20 part 2: Max. dose and percentage can be supplied after consultation with a herbalist, anything exceeding this can only be sold in a pharmacy under pharmacist supervision
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64
Q

What are the main groups of herbal products listed under schedule 20?

A
  • Part 1: Daily anthelmintics and irritants

- Part 2: Alcaloids

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65
Q

Why may herbal products containing aconite have adverse effects?

A
  • Extremely poisonous

- Cardiotoxic

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66
Q

What herbal remedies can be sold by pharmacists?

A
  • Substances in pt1 and pt2 of schedule 20

- Anything that can be sold by a herbal practitioner, shopkeeper or herbal dealer

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67
Q

What herbal remedies can be sold by herbal practitioners?

A
  • Any substances in pt2
  • GSL herbal medicines
  • Anything that can be sold by a shopkeeper or herbal dealer
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68
Q

What are the conditions for sale of herbal remedies by herbal practitioners?

A
  • If remedy requested by person present

- Written record of sale/supply given to UK enforcement authority

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69
Q

What herbal remedies can be sold by shopkeepers/herbal dealers?

A
  • GSL herbal medicines
  • Products with a traditional herbal registration
  • Food supplements or cosmetics
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70
Q

What are the conditions for a product to be given a traditional herbal registration?

A
  • Used without need for medical practitioner
  • Intended for use at a specific dose/strength
  • Intended for oral, inhaled or external administration
  • Been in use for min 30 years and 15 in the EU
  • Traditional use should be effective and not harmful
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71
Q

What are the labelling requirements for traditional herbal medicines?

A
  • Statement that product is a herbal medicine for a specific purpose
  • Statement advising patient to seek medical attention if experiencing adverse effects
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72
Q

What license is required for importation of a traditional herbal medicinal product from a non EU country

A

Wholesale’s (import) license

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73
Q

What statements must be included in adverts for traditional herbal medicinal products?

A

‘THMP for use for [indication] exclusively based upon long standing use as a traditional remedy’

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74
Q

What regulatory body is responsible for the registration, manufacture and SPC of THMP? What powers do they have?

A

MHRA

Can ban sale or supply of herbal remedies that are thought to have adverse effects

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75
Q

How are THMP adverse effects reported?

A

Yellow card scheme

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76
Q

What are homeopathics?

A

Self treatment for minor conditions

Usually products in high dilutions

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77
Q

What is the national rules scheme similar to?

A

MA - but for homeopathics

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78
Q

What is the purpose of advertisements for medicinal products?

A

Promote prescription, sale, supply and use of the product

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79
Q

What are the methods of advertisement for medicinal products?

A
  • Door-to-door canvassing
  • Medical sales representatives visits (to those qualified to prescribe or supply)
  • Samples
  • Benefit of bonus to induce prescription or supply of product
  • Sponsorship of promotional meetings attended by those who can prescribe or supply
  • Sponsorship of scientific congresses
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80
Q

What are the different places of advertisement?

A
  • Medical journals, magazines, newspapers
  • Posters, public billboards
  • TV, radio, internet
  • Films/cinema
  • Letters (circulating or direct)
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81
Q

When may a medicines advertisement be changed by the advertising standards authority?

A

If it is deemed misleading

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82
Q

Which regulatory body must confirm advertisements before their release?

A

MHRA

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83
Q

Which substances may have their promotional material vetted?

A
  • New active substances with MAs
  • Reclassified products
  • Products that may have previously breached advertising regulations
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84
Q

What happens in the cases of a complaint against a medicines advertisement?

A
  • Handled by MHRA or self-regulatory bodies

- Outcome of investigation published

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85
Q

What are the self-regulatory bodies and what advertising does each manage?

A
  • Advertising Standard Authority - General advertising
  • Proprietary Association of Great Britain - OTC medicine advertising
  • Prescription Medicines Code of Practice Authority - POM advertising
86
Q

What is the purpose of product licensing?

A

Determines who may be supplied with the product and, therefore, who it may be advertised to

87
Q

What are the regulations an advertisement must stick to and what may be included?

A
  • Must not be offensive, misleading or promote unrealistic expectations
  • Information from SPCs may be included in an advert
88
Q

What type of information can be given in an advertisement?

A

Factual announcements but not product claims

89
Q

What is the legal basis for the control of medicines advertising?

A

Part 14 of HMR

90
Q

What are the quality standards for medicines advertising?

A
  • Comply with SPC particulars
  • Encourage rational use - do not exaggerate
  • Ensure advert is not misleading
91
Q

How long should advertising records be kept by the license holder?

A

Minimum 3 years

92
Q

Which medicines can be advertised to the public?

A
  • P medicines
  • GSL medicines
  • Vaccines
93
Q

What are the guidelines for advertising medicines to the public?

A
  • Clear that product is a medicine
  • Information for correct use
  • Indicate that safe use is dependent of compliance
  • Not suggestive or comparative
  • Does not make any guarantees or suggest there is no need for a consultation
  • No claims about side effects or purity, speed claims ONLY if relevant
  • Advise against volume based promotions
94
Q

Who is regarded as persons qualified to prescribe (PQPS)?

A
  • Those to which medicinal products are sold or supplied to in the course of their business/profession
  • Those who are legally entitled to prescribe a chosen medicine
  • Those who can provide advice on medicine at the point of sale
95
Q

Can medicines be advertised to health professionals on the internet?

A

Yes, as long as they comply with the standard regulations

96
Q

When can POMs be advertised on the internet?

A

If content is specifically aimed at healthcare professionals

97
Q

What must full and short form adverts for PQPS contain?

A
  • Full: Information relating to SPC
  • Wording relating to technical knowledge of the PQPS
  • Short form: Information relating to SPC but detailed prescribing information on a specified website
98
Q

What are promotional aids and what should they contain?

A

Simply a reminder, only the medicine name

99
Q

What is the guidance for giving samples?

A
  • Only to those who can prescribe
  • Exceptional basis
  • Compliance with max. no. of annual supplies
  • Only supplied against written requests
  • Control and accountability lies with supplier
  • Max sample should be smallest amount for sale
  • Sample accompanied by SPC
100
Q

What are the regulations for medical sales representatives?

A
  • Have appropriate training and knowledge
  • Provide everyone they visit with SPC
  • Safety information from healthcare professionals should be relayed back to scientific services set up by license holder
101
Q

What is the purpose of advertisements for medicinal products?

A

Promote prescription, sale, supply and use of the product

102
Q

What are the methods of advertisement for medicinal products?

A
  • Door-to-door canvassing
  • Medical sales representatives visits (to those qualified to prescribe or supply)
  • Samples
  • Benefit of bonus to induce prescription or supply of product
  • Sponsorship of promotional meetings attended by those who can prescribe or supply
  • Sponsorship of scientific congresses
103
Q

What are the different places of advertisement?

A
  • Medical journals, magazines, newspapers
  • Posters, public billboards
  • TV, radio, internet
  • Films/cinema
  • Letters (circulating or direct)
104
Q

When may a medicines advertisement be changed by the advertising standards authority?

A

If it is deemed misleading

105
Q

Which regulatory body must confirm advertisements before their release?

A

MHRA

106
Q

Which substances may have their promotional material vetted?

A
  • New active substances with MAs
  • Reclassified products
  • Products that may have previously breached advertising regulations
107
Q

What happens in the cases of a complaint against a medicines advertisement?

A
  • Handled by MHRA or self-regulatory bodies

- Outcome of investigation published

108
Q

What are the self-regulatory bodies and what advertising does each manage?

A
  • Advertising Standard Authority - General advertising
  • Proprietary Association of Great Britain - OTC medicine advertising
  • Prescription Medicines Code of Practice Authority - POM advertising
109
Q

What is the purpose of product licensing?

A

Determines who may be supplied with the product and, therefore, who it may be advertised to

110
Q

What are the regulations an advertisement must stick to and what may be included?

A
  • Must not be offensive, misleading or promote unrealistic expectations
  • Information from SPCs may be included in an advert
111
Q

What type of information can be given in an advertisement?

A

Factual announcements but not product claims

112
Q

What is the legal basis for the control of medicines advertising?

A

Part 14 of HMR

113
Q

What are the quality standards for medicines advertising?

A
  • Comply with SPC particulars
  • Encourage rational use - do not exaggerate
  • Ensure advert is not misleading
114
Q

How long should advertising records be kept by the license holder?

A

Minimum 3 years

115
Q

Which medicines can be advertised to the public?

A
  • P medicines
  • GSL medicines
  • Vaccines
116
Q

What are the guidelines for advertising medicines to the public?

A
  • Clear that product is a medicine
  • Information for correct use
  • Indicate that safe use is dependent of compliance
  • Not suggestive or comparative
  • Does not make any guarantees or suggest there is no need for a consultation
  • No claims about side effects or purity, speed claims ONLY if relevant
  • Advise against volume based promotions
117
Q

Who is regarded as persons qualified to prescribe (PQPS)?

A
  • Those to which medicinal products are sold or supplied to in the course of their business/profession
  • Those who are legally entitled to prescribe a chosen medicine
  • Those who can provide advice on medicine at the point of sale
118
Q

Can medicines be advertised to health professionals on the internet?

A

Yes, as long as they comply with the standard regulations

119
Q

When can POMs be advertised on the internet?

A

If content is specifically aimed at healthcare professionals

120
Q

Are there any restrictions on the receipt or supply of isopropyl alcohol 70%?

A

No authorisation required

121
Q

What are promotional aids and what should they contain?

A

Simply a reminder, only the medicine name

122
Q

What is the guidance for giving samples?

A
  • Only to those who can prescribe
  • Exceptional basis
  • Compliance with max. no. of annual supplies
  • Only supplied against written requests
  • Control and accountability lies with supplier
  • Max sample should be smallest amount for sale
  • Sample accompanied by SPC
123
Q

What are the regulations for medical sales representatives?

A
  • Have appropriate training and knowledge
  • Provide everyone they visit with SPC
  • Safety information from healthcare professionals should be relayed back to scientific services set up by license holder
124
Q

What legislation controls the sale and supply of denatured alcohol?

A
  • Alcoholic Liquors Duties Act

- Denatured Alcohol Regulations

125
Q

What is denatured alcohol?

A

Denaturants are added to make the alcohol unsuitable for drinking

126
Q

What is a Justice’s License and when is it not required?

A
  • Allows sale of intoxicating liquids

- Not required for sale of medicine made with alcohol by a pharmacist

127
Q

What is completely denatured alcohol and what is it made of?

A
  • Mineralised methylated spirits
  • 3 parts isopropyl alcohol, 3 parts methyl ethyl ketone and 1g denatonium benzoate per every 100 parts alcohol
  • May contain methyl violet
128
Q

What are the uses for completely denatured alcohol?

A

Heating
Lighting
General domestic use

129
Q

Are there any restrictions on the supply of completely denatured alcohol?

A

No, supplied to anyone with no quantity restriction/conditions of use

130
Q

Are there any restrictions or records for retails of completely denatured alcohol?

A
  • No, but should be suitably stored

- Pharmacies can purchase from wholesale dealers in any quantity

131
Q

What does industrial denatured alcohol consist of and what are its uses?

A
  • 95% v/v alcohol and 5% v/v wood naphtha (or substitute)
  • Solvent in industry
  • External medical applications
132
Q

What is trade specific denatured alcohol and what are some of the approved formulations?

A
  • Approved to meet specific trade needs

- Perfumes, toiletries, cosmetics, medicated creams/ointments, disinfectants for sterile environments

133
Q

How can IDA or TDSA be obtained?

A
  • Revenue and customs written authorisation form from retail or hospital pharmacies
  • Form states what can be received, use and conditions to be observed
  • Authorisation has no expiry but reviewed periodically
134
Q

What quantities of IDA/TDSA can be obtained once pharmacists have authorisation?

A
  • 20+ litres if from authorised producer/wholesaler

- <20 litres if from others with authorisation

135
Q

What should be given to the supplier before a pharmacist can obtain denatured alcohol?

A

Copy of the authorisation

136
Q

What are the conditions for the sale or supply of IDA/TDSA?

A
  • Only used as authorised
  • Records of dealings and quantities kept
  • Written signed orders from practitioners kept
  • Annual return to revenue and customs if requested
137
Q

What are the storage requirements for alcohols?

A

Kept under lock and key unless otherwise specified by revenue and customs
Stock take records

138
Q

What should be done when IDA/TDSA is received?

A
  • Amount received recorded in supplier dispatch document and pharmacy records
  • Signed copy should be returned to supplier as receipt
139
Q

What are the storage requirements for regulated and reportable substances?

A
  • Stored alone with no customer access
  • Kept away from food items
  • Risk assessment before storing/selling
140
Q

What are the conditions for sale/supply of IDA/TDSA from a pharmacist for medical use?

A
  • Medical, surgical, dental or veterinary purpose
  • Requested by prescription or written order
  • Patient/Animal owner/Prescriber do not need authorisation
  • Prescription: Dispense and keep record
  • Written order: Any quantity and class but must be specified, written order kept
141
Q

What are surgical spirits and what are they used for?

A
  • 85-95% ethanol, 1-5% methanol

- External use only

142
Q

What are duty-free spirits and what are the conditions of use?

A
  • Used to make up a prescribed product by pharmacist
  • Application to revenue and customs to obtain and use
  • Stock book records kept
143
Q

Are there any restrictions on the receipt or supply of isopropyl alcohol 70%?

A

No authorisation required

144
Q

What should be known if non-medicinal chemicals are requested from a pharmacist by a customer?

A

Who, what, how much, and purpose intended

145
Q

What are the exemptions for a vet/pharmacist being present when handing over a VMP?

A
  • Individual transaction has been approved before supply

- Vet/pharmacist is satisfied that person handing medicine over is competent

146
Q

How are chemical classifications decided?

A

Investigating the impact of chemical supply on you, others and the environment

147
Q

What are the GHS and CLP regulations?

A

GHS: Globally harmonised system on classification/labelling of chemicals
CLP regulation: Classification, labelling and packaging of substances and mixtures (European)

148
Q

What are the physicochemical danger properties of chemicals?

A 
Explosive
Oxidising
Flammable
Highly flammable
Extremely flammable
149
Q

What are the danger health effects of chemicals?

A 
Toxic
Very toxic
Harmful
Corrosive
Irritant
Sensitising
Carcinogenic
Mutagenic
Toxic for reproduction
150
Q

What other adverse effects may chemical have?

A

Environmental effects

151
Q

Which chemicals are not subject to CLP regulation? Give some examples of these

A

Chemicals in the finished state

Medicines/medical devices, vet medicines, food, cosmetics, feeding stuffs)

152
Q

What is the pharmacist’s role in the sale/supply of chemicals?

A
  • Retailer: Limited duties compared to manufacturer, importer or downstream user
  • If sold to third party consumers: Use classification and labelling from manufacturer/importer
  • If part of supply chain: Responsible for correct labelling and packaging before marketing
153
Q

What is the aim of a label on a chemical;?

A

Tell users about hazards and provide brief precautionary advice

154
Q

What particulars should be included on the label of a chemical?

A
  • Name, address and tel no of supplier
  • Name and quantity of substance
  • Product identifiers
  • Hazard information (where appropriate)
155
Q

What are the requirements for packaging of chemicals?

A
  • Prevent chemical escaping without being affected itself
  • Withstand repeated normal handling
  • Child resistant opening if available to public
  • Danger warnings
156
Q

What chemicals may chiropodists and podiatrists use in practice?

A
  • Liquid phenol
  • Pyrogallol
  • Monochloroacetic acid
  • Salicylic acid
157
Q

What legislation covers use of poisons?

A
  • If used as medicine - HMR

- If not - Poisons Act

158
Q

What do the different part of the poisons act cover?

A
  • Parts 1+2: Regulated poisons or explosive precursors

- Parts 3+4: Reportable poisons or explosive precursors

159
Q

What are the regulations for purchase of regulated substances?

A
  • Explosive precursor and poisons license required (valid for 3 years)
  • License and photo ID required when purchasing
  • Suspicious activity should be checked and reported by pharmacy team
160
Q

What records should be made for the purchase of regulated substances?

A
  • Poisons records for pt2 substances - Contains date, name and address of purchaser, name and amount of poison, purpose, signature
  • Pt1 and 2 substances - Record made on back of license
161
Q

When can unauthorised vet medicines be sold/supplied?

A

Under veterinary cascade

162
Q

What are the storage requirements for regulated and reportable substances?

A
  • Stored alone with no customer access
  • Kept away from food items
  • Risk assessment before storing/selling
163
Q

What are authorised vet medicinal products?

A

List of UK products as well as SPCs

164
Q

What are the regulations surrounding VMPs?

A

Similar to HMP, MA required, manufacture/wholesale/records all still apply

165
Q

What are the VMP distribution categories and who can prescribe from each?

A
  • POM-V: Only vets can prescribe
  • POM-VPS: Vets, pharmacists and suitably qualified people
  • NFA-VPS: Non-food animal products, same prescribers as POM-VPS
  • AVM-GSL: General sale of authorised vet medicines
166
Q

What are the requirements for vets to prescribe and supply VMPs?

A

Have to be registered with the RCVS

167
Q

Where can VMPs be supplied from?

A

Veterinary practice premises registered with the RCVS or registered pharmacy

168
Q

What are the exemptions for a vet being present when handing over a VMP?

A
  • Individual transaction has been approved by vet before supply
  • Vet is satisfied that person handing medicine over is competent
169
Q

Who is classed as a suitably qualified person when prescribing vet medicines and what are the requirements?

A
  • Animal medicines advisor
  • Can prescribe and supply certain medicines
  • Have to pass exam and be registered
170
Q

Who is responsible for the training and registration of an animal medicines advisor?

A
  • Animal Medicines Training Regulatory Authority

- Vet Skills ltd

171
Q

What medicines are classified as POM-V and why do they require specialist vet knowledge?

A
  • Schedule 2+3 CDs
  • Products with new active substances
  • Products containing narcotic or psychotropic substances
  • Narrow safety margin elicits high level of control
  • Only minimum amount should ever be prescribed
172
Q

When is a medicine classified as POM-VPS?

A
  • Used to reduce/prevent effects of endemics
  • May be risk for animal, user, environment but countermeasures can be provided
  • Professional users can be given training relating to use
173
Q

What is covered under POM-V/POM-VPS?

A
  • Products for food-producing animals
  • Products requiring special precautions
  • Products that may interfere with future diagnosis
  • New products
174
Q

What are NFA-VPS medicines used for?

A

Non-food producing animals

175
Q

What are the exemptions for small pet animals?

A
  • Products can be marketed without an MA if labelled exclusively for use in aquarium animals, cage birds, homing pigeons, terrarium animals, small rodents, ferrets and rabbits
  • Products sold by any retailer
176
Q

What must be done in the retail supply of VMPs?

A
  • Recipient has to be competent for use and should be given advise on safe administration
  • Give info on contraindications and warnings
  • Min. amount of products supplied
177
Q

What are the requirements for POM-V/POM-VPS records?

A
  • Medicine name and quantity
  • Batch no
  • Date
  • Name and address of supplier/recipient and prescriber
  • Keep copy of prescription
  • Keep records for 5 years
178
Q

When should a prescription for a POM-V/POM-VPS be written and not verbal?

A

If supplier and prescriber are different

179
Q

What are the legal requirements for a veterinary prescription?

A
  • Prescriber name, address, tel no, qualification and signature
  • RCVS reg no. if CD2/3
  • Animal owner name and address
  • Species and identification of animal
  • Animal address (if different to owner)
  • Date
  • Medicine name, quantity, dose and administration instructions
  • Warnings (e.g. time between medicine administration and animal use for food)
  • No. of repeats (if required)
  • Statement for prescribing under veterinary cascade (if appropriate)
  • Statement of vet prescribing for animal if CD2/3
180
Q

How should VMPs be labelled?

A
  • State ‘UK authorised VMP’
  • Name, strength and formulation of medicine
  • Name and proportion of active substance
  • RoA
  • Batch no and expiry date
  • “For animal treatment only”
  • Contents by volume/dosage units
  • MA number and name/address of holder
  • Target species and distribution category
181
Q

What should be done before taking on the role of the responsible pharmacist?

A
  • Check staff presence, systems and messages
  • Is notice displayed?
  • Has pharmacy record been completed?
  • Are they aware of all aspects of SOPs?
  • Do they plan to be absent and do they have procedures in place for this?
  • Have fridge temps been checked?
  • Do they know where the CD cupboard keys are?
182
Q

What is the veterinary cascade?

A

Used to treat animals where there is no authorised treatment

  • Step 1: For use in other species/different indication in same species
  • Step 2: For human use in UK or any animal in EU
  • Step 3: Extemporaneously prepared
183
Q

Who can prescribe and dispense under the veterinary cascade?

A

Only vets can prescribe but pharmacists can dispense against a prescription

184
Q

When can unauthorised vet medicines be sold/supplied?

A

Under veterinary cascade

185
Q

How did the Health Act alter the Medicines Act?

A
  • More regulations to provide more detail on pharmacist role

- Secure sale and supply of medicines but not necessarily always there to supervise (more clinical role)

186
Q

What is a body corporate?

A

Large chains owning multiple pharmacies

187
Q

What is the role of a superintendent?

A
  • All body corporates must have one
  • Make sure every pharmacy has a responsible pharmacist
  • Look after all pharmaceutical business of body corporate
188
Q

Whose responsibility is it to ensure that there is a responsible pharmacist in a pharmacy?

A
  • Superintendent, chief pharmacist or owner (in GPhC registered sites)
  • Chief pharmacist (in hospital pharmacies as they are not always registered)
189
Q

Who may have the role of the responsible pharmacist?

A
  • Owner
  • Partner
  • Registered pharmacist employed there
  • Superintendent (smaller body corporates)
190
Q

What must be displayed in a pharmacy?

A

Responsible pharmacist notice containing name, GPhC no. and statement saying they are in charge

191
Q

What does a pharmacy record contain?

A

Name and GPhC no. of the responsible pharmacist and the time period which they covered

192
Q

What is the role of the responsible pharmacist?

A

Responsible for keeping SOPs and records

193
Q

What should be done in the responsible pharmacist’s absence?

A
  • Record date and time period

- Reason is good practice

194
Q

What are the requirements for a pharmacy record?

A
  • Electronic or in writing
  • Keep for 5 years
  • Daily or continuous entry (NOT IN ADVANCE)
  • Alterations identifiable
195
Q

What is the role of the responsible pharmacist in pharmacy procedures?

A
  • Establish, maintain and review procedures
  • Procedures either electronic or in writing
  • Must date procedure when prepared and reviewed (ideally every 2 years)
  • Mark temporary changes
196
Q

What are the requirements for SOPs?

A
  • What to do in absence of RP
  • Arrangements for safe and effective journey of medicines
  • Provide medicines advice for non-pharmacists
  • Activities undertaken by each role
  • Record keeping
  • Handling complaints/adverse incidents
197
Q

When should there be a responsible pharmacist and how long can they be absent for?

A
  • When pharmacy is operating (may be outside of opening hours)
  • 2 hours per 24 hour period
198
Q

What are the requirements for the absence of a responsible pharmacist?

A
  • Easily contactable and able to return

- Procedures in place if this is not possible

199
Q

Define supervision

A

Pharmacist has to be present and able to advise during a transaction

200
Q

What activities require a responsible pharmacist to be in charge and present?

A
  • Clinical/legal check of a prescription
  • Sale/supply of P/POMs
  • Supply under PGD
  • Emergency supply
201
Q

What activities require responsible pharmacist to be in charge and supervising but not physically present?

A

Assembly process

202
Q

What activities require a responsible pharmacist to be in charge but not present or supervising?

A
  • Sale of GSL

- Processing of waste stock/patient returned medicines

203
Q

What activities do not require a responsible pharmacist?

A
  • Stock orders
  • Receiving stock
  • Putting away stock
  • Date checking
  • Receiving prescriptions
  • Delivering checked prescriptions and medication
204
Q

What should be done before taking on the role of the responsible pharmacist?

A
  • Check staff presence, systems and messages
  • Is notice displayed?
  • Has pharmacy record been completed?
  • Are they aware of all aspects of SOPs?
  • Do they plan to be absent and do they have procedures in place for this?
  • Have fridge temps been checked?
  • Do they know where the CD cupboard keys are?
205
Q

What are the premises/supervision requirements for the sale and supply of medicines?

A

Sale in registered premises
Sale and supply under supervision of pharmacist

UNLESS GSL

206
Q

What is a retail pharmacy?

A
  • Premises registered with the GPhC or PSNI
  • Business which consists of the retail sale of medicines
  • Responsible pharmacist in charge
207
Q

Who may own a retail pharmacy business?

A
  • Individual pharmacist
  • Body corporate
  • Pharmacist representative
208
Q

In what circumstances can pharmacist representatives carry on a retail pharmacy business?

A
  • Pharmacist has died
  • Bankruptcy
  • Suffering from mental disorder
209
Q

What are the conditions of a pharmacist representative?

A
  • Have to inform GPhC
  • Can continue for 5 years in case of death
  • Can continue for 3 years in other cases
210
Q

How do body corporates relate to legal responsibility?

A

Act together and therefore accept legal responsibility as one

211
Q

What are the requirements for a superintendent of a body corporate?

A
  • Have to be a pharmacist
  • Signed statement of appointment sent to GPhC
  • Only works for one body corporate
  • May be responsible pharmacist
  • Full-time position

Pharmacy Year 2 (9 decks)

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