Law - Semester 2 Flashcards
1
Q
Which regulations determine licensing requirements?
A
HMR
2
Q
Which aspects of medicines does licensing affect?
A
Manufacture
Sale
Supply
Importation
3
Q
Which bodies can provide licensing for medicines?
A
Medicines and Healthcare products Regulatory Agency (MHRA)
European Medicines Agency (EMA)
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
5
Q
What medicinal products are covered by licensing legislation?
A
- Authorised medicinal product
- Investigation medicinal products
6
Q
Which stages does licensing legislation cover?
A
Initial development and research through to final marketing
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
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
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
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
11
Q
What type of products may require application for a marketing authorisation?
A
- New active substances
- Generic medicinal products
- Biological/Biotechnology products
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
13
Q
How long is an initial marketing authorisation valid for?
A
5 years
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
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
16
Q
What must a marketing authorisation holder produce regarding safety?
A
Periodic safety update report
17
Q
When may a product name be rejected by the MHRA?
A
if name is misleading, could cause confusion or is generally unsafe
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
19
Q
How do clinical trials for paediatric medicines differ to adult clinical trials?
A
Clinical trials for every age group within paeds
20
Q
What are the EU regulations to increase availability of medicines for paeds?
A
- Paediatric investigation plan
- Paediatric use marketing authorisation
21
Q
What legislation sets out the labelling requirements for relevant medicinal products?
A
HMR and Misuse of Drugs Regulations
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
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
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
25
What is the difference between the labelling of a small container and a blister pack?
All requirements of a blister pack but method of administration too
26
What are the labelling requirements for paracetamol?
- '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
27
Define manufacture
Any process carried out in the course of making the product
Not simply dissolving, dispersing, diluting or mixing the substance with a vehicle
28
Define assembly
Dividing up, packaging and presentation of the substance
29
What does a manufacturer's license enable the holder to do?
- Manufacture or assemble licensed medicinal products
- Export product to countries outside the EEA
- Import licensed products from outside the EEA
30
What must the licensing authority know before granting a license?
- Operations to be carried out
- Premises
- Equipment available
- Qualifications of supervisors
- Safekeeping records
- Maintenance of adequate records
31
Who must hold a marketing authorisation before its manufacture?
Manufacturer OR person ordering the product
32
What does a manufacturer 'specials' license allow the holder to do?
- Manufacture of unlicensed medicines
| - Import unlicensed products from outside the EEA
33
When is a 'specials' license not required?
If special product is being extemporaneously prepared in pharmacy
34
When are unlicensed products used?
- 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)
35
What is a manufacturers license for investigational medicinal products?
- Allows manufacture of IMPs for clinical trials
| - For phase 1, 2 and 3 clinical trials
36
Define wholesale dealing
Supplied to someone before the medicine reaches the patient
37
What classifications can be sold with a wholesale dealers license?
- Pharmacy
- POM
- Traditional herbal medicines
- GSL medicines
38
What other action can be undertaken with a wholesale dealers license?
Import of unlicensed products from inside the EEA
39
Who can medicines be distributed to?
- 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
40
What are the conditions of a wholesale license?
- 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
41
When are licenses not required?
- 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
42
What are the conditions for own name products and is a license required to produce them?
No license - prepared under pharmacist supervision and not advertised to public
43
When are doctors and dentists exempt from licensing?
When preparing or assembling products on an individual patient basis
44
When are nurses and midwives exempt from licensing?
When assembling medicines for individual patients
45
What are the herbalist exemptions to licensing?
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
46
When do manufacturers/marketing authorisation holders not require a wholesale dealers license?
If marketing own product
47
When is a wholesale dealers license not required for importing a product?
If product is imported for a specific patient
48
When is a wholesale dealers license not required for exporting a product?
If product is being re-exported without making any alterations
49
When is a marketing authorisation required for food and cosmetics?
If promoting products to practitioners
50
When do food and cosmetics require appropriate licensing?
If administered orally for beneficial/medicinal purposes - has a stated dose
51
When do vitamins require licensing?
- Oral administration with no dosage direction
- If dose exceeds a specified amount
- If foods with added vitamins exceed the daily range
52
Cosmetics containing what excipients must be appropriately licensed?
- Antibiotics
- 0.004% or more of a hormone
- 0.1% or more of hexachlorophane
- More than 1% resorcinol
53
What is a herbal medicinal product?
Products where the only active substances are herbal substances or preparations
54
Define 'herbal substance'
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
55
Define 'herbal preparation'
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
56
What are the types of herbal remedies and what licensing does each require?
- 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)
57
Who are recognised suppliers of herbal remedies?
- Pharmacists
- Dealers - give product requested
- Practitioners - Prescribe using specialist knowledge
58
When can practitioners deal in any herbs?
Following 1-1 consultation and if patient is present
59
When do HMR restrictions for sale and supply of herbal products not apply?
- 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
60
What ingredients prohibit the manufacture, sale, supply and importation of unlicensed medicines?
- Aristolochia
| - Mu Tong
61
What ingredient prohibits the sale, supply and importation of products (unless for external use)?
Kava kava
62
What ingredient cannot be sold, supplied or imported?
Senecio
63
What are the restrictions of supply of herbal medicinal products by herbalists?
- 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
64
What are the main groups of herbal products listed under schedule 20?
- Part 1: Daily anthelmintics and irritants
| - Part 2: Alcaloids
65
Why may herbal products containing aconite have adverse effects?
- Extremely poisonous
| - Cardiotoxic
66
What herbal remedies can be sold by pharmacists?
- Substances in pt1 and pt2 of schedule 20
| - Anything that can be sold by a herbal practitioner, shopkeeper or herbal dealer
67
What herbal remedies can be sold by herbal practitioners?
- Any substances in pt2
- GSL herbal medicines
- Anything that can be sold by a shopkeeper or herbal dealer
68
What are the conditions for sale of herbal remedies by herbal practitioners?
- If remedy requested by person present
| - Written record of sale/supply given to UK enforcement authority
69
What herbal remedies can be sold by shopkeepers/herbal dealers?
- GSL herbal medicines
- Products with a traditional herbal registration
- Food supplements or cosmetics
70
What are the conditions for a product to be given a traditional herbal registration?
- 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
71
What are the labelling requirements for traditional herbal medicines?
- Statement that product is a herbal medicine for a specific purpose
- Statement advising patient to seek medical attention if experiencing adverse effects
72
What license is required for importation of a traditional herbal medicinal product from a non EU country
Wholesale's (import) license
73
What statements must be included in adverts for traditional herbal medicinal products?
'THMP for use for [indication] exclusively based upon long standing use as a traditional remedy'
74
What regulatory body is responsible for the registration, manufacture and SPC of THMP? What powers do they have?
MHRA
| Can ban sale or supply of herbal remedies that are thought to have adverse effects
75
How are THMP adverse effects reported?
Yellow card scheme
76
What are homeopathics?
Self treatment for minor conditions
Usually products in high dilutions
77
What is the national rules scheme similar to?
MA - but for homeopathics
78
What is the purpose of advertisements for medicinal products?
Promote prescription, sale, supply and use of the product
79
What are the methods of advertisement for medicinal products?
- 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
80
What are the different places of advertisement?
- Medical journals, magazines, newspapers
- Posters, public billboards
- TV, radio, internet
- Films/cinema
- Letters (circulating or direct)
81
When may a medicines advertisement be changed by the advertising standards authority?
If it is deemed misleading
82
Which regulatory body must confirm advertisements before their release?
MHRA
83
Which substances may have their promotional material vetted?
- New active substances with MAs
- Reclassified products
- Products that may have previously breached advertising regulations
84
What happens in the cases of a complaint against a medicines advertisement?
- Handled by MHRA or self-regulatory bodies
| - Outcome of investigation published
85
What are the self-regulatory bodies and what advertising does each manage?
- Advertising Standard Authority - General advertising
- Proprietary Association of Great Britain - OTC medicine advertising
- Prescription Medicines Code of Practice Authority - POM advertising
86
What is the purpose of product licensing?
Determines who may be supplied with the product and, therefore, who it may be advertised to
87
What are the regulations an advertisement must stick to and what may be included?
- Must not be offensive, misleading or promote unrealistic expectations
- Information from SPCs may be included in an advert
88
What type of information can be given in an advertisement?
Factual announcements but not product claims
89
What is the legal basis for the control of medicines advertising?
Part 14 of HMR
90
What are the quality standards for medicines advertising?
- Comply with SPC particulars
- Encourage rational use - do not exaggerate
- Ensure advert is not misleading
91
How long should advertising records be kept by the license holder?
Minimum 3 years
92
Which medicines can be advertised to the public?
- P medicines
- GSL medicines
- Vaccines
93
What are the guidelines for advertising medicines to the public?
- 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
Who is regarded as persons qualified to prescribe (PQPS)?
- 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
Can medicines be advertised to health professionals on the internet?
Yes, as long as they comply with the standard regulations
96
When can POMs be advertised on the internet?
If content is specifically aimed at healthcare professionals
97
What must full and short form adverts for PQPS contain?
- 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
What are promotional aids and what should they contain?
Simply a reminder, only the medicine name
99
What is the guidance for giving samples?
- 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
What are the regulations for medical sales representatives?
- 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
What is the purpose of advertisements for medicinal products?
Promote prescription, sale, supply and use of the product
102
What are the methods of advertisement for medicinal products?
- 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
What are the different places of advertisement?
- Medical journals, magazines, newspapers
- Posters, public billboards
- TV, radio, internet
- Films/cinema
- Letters (circulating or direct)
104
When may a medicines advertisement be changed by the advertising standards authority?
If it is deemed misleading
105
Which regulatory body must confirm advertisements before their release?
MHRA
106
Which substances may have their promotional material vetted?
- New active substances with MAs
- Reclassified products
- Products that may have previously breached advertising regulations
107
What happens in the cases of a complaint against a medicines advertisement?
- Handled by MHRA or self-regulatory bodies
| - Outcome of investigation published
108
What are the self-regulatory bodies and what advertising does each manage?
- Advertising Standard Authority - General advertising
- Proprietary Association of Great Britain - OTC medicine advertising
- Prescription Medicines Code of Practice Authority - POM advertising
109
What is the purpose of product licensing?
Determines who may be supplied with the product and, therefore, who it may be advertised to
110
What are the regulations an advertisement must stick to and what may be included?
- Must not be offensive, misleading or promote unrealistic expectations
- Information from SPCs may be included in an advert
111
What type of information can be given in an advertisement?
Factual announcements but not product claims
112
What is the legal basis for the control of medicines advertising?
Part 14 of HMR
113
What are the quality standards for medicines advertising?
- Comply with SPC particulars
- Encourage rational use - do not exaggerate
- Ensure advert is not misleading
114
How long should advertising records be kept by the license holder?
Minimum 3 years
115
Which medicines can be advertised to the public?
- P medicines
- GSL medicines
- Vaccines
116
What are the guidelines for advertising medicines to the public?
- 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
Who is regarded as persons qualified to prescribe (PQPS)?
- 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
Can medicines be advertised to health professionals on the internet?
Yes, as long as they comply with the standard regulations
119
When can POMs be advertised on the internet?
If content is specifically aimed at healthcare professionals
120
Are there any restrictions on the receipt or supply of isopropyl alcohol 70%?
No authorisation required
121
What are promotional aids and what should they contain?
Simply a reminder, only the medicine name
122
What is the guidance for giving samples?
- 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
What are the regulations for medical sales representatives?
- 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
What legislation controls the sale and supply of denatured alcohol?
- Alcoholic Liquors Duties Act
| - Denatured Alcohol Regulations
125
What is denatured alcohol?
Denaturants are added to make the alcohol unsuitable for drinking
126
What is a Justice's License and when is it not required?
- Allows sale of intoxicating liquids
| - Not required for sale of medicine made with alcohol by a pharmacist
127
What is completely denatured alcohol and what is it made of?
- 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
What are the uses for completely denatured alcohol?
Heating
Lighting
General domestic use
129
Are there any restrictions on the supply of completely denatured alcohol?
No, supplied to anyone with no quantity restriction/conditions of use
130
Are there any restrictions or records for retails of completely denatured alcohol?
- No, but should be suitably stored
| - Pharmacies can purchase from wholesale dealers in any quantity
131
What does industrial denatured alcohol consist of and what are its uses?
- 95% v/v alcohol and 5% v/v wood naphtha (or substitute)
- Solvent in industry
- External medical applications
132
What is trade specific denatured alcohol and what are some of the approved formulations?
- Approved to meet specific trade needs
| - Perfumes, toiletries, cosmetics, medicated creams/ointments, disinfectants for sterile environments
133
How can IDA or TDSA be obtained?
- 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
What quantities of IDA/TDSA can be obtained once pharmacists have authorisation?
- 20+ litres if from authorised producer/wholesaler
| - <20 litres if from others with authorisation
135
What should be given to the supplier before a pharmacist can obtain denatured alcohol?
Copy of the authorisation
136
What are the conditions for the sale or supply of IDA/TDSA?
- 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
What are the storage requirements for alcohols?
Kept under lock and key unless otherwise specified by revenue and customs
Stock take records
138
What should be done when IDA/TDSA is received?
- Amount received recorded in supplier dispatch document and pharmacy records
- Signed copy should be returned to supplier as receipt
139
What are the storage requirements for regulated and reportable substances?
- Stored alone with no customer access
- Kept away from food items
- Risk assessment before storing/selling
140
What are the conditions for sale/supply of IDA/TDSA from a pharmacist for medical use?
- 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
What are surgical spirits and what are they used for?
- 85-95% ethanol, 1-5% methanol
| - External use only
142
What are duty-free spirits and what are the conditions of use?
- Used to make up a prescribed product by pharmacist
- Application to revenue and customs to obtain and use
- Stock book records kept
143
Are there any restrictions on the receipt or supply of isopropyl alcohol 70%?
No authorisation required
144
What should be known if non-medicinal chemicals are requested from a pharmacist by a customer?
Who, what, how much, and purpose intended
145
What are the exemptions for a vet/pharmacist being present when handing over a VMP?
- Individual transaction has been approved before supply
| - Vet/pharmacist is satisfied that person handing medicine over is competent
146
How are chemical classifications decided?
Investigating the impact of chemical supply on you, others and the environment
147
What are the GHS and CLP regulations?
GHS: Globally harmonised system on classification/labelling of chemicals
CLP regulation: Classification, labelling and packaging of substances and mixtures (European)
148
What are the physicochemical danger properties of chemicals?
```
Explosive
Oxidising
Flammable
Highly flammable
Extremely flammable
```
149
What are the danger health effects of chemicals?
```
Toxic
Very toxic
Harmful
Corrosive
Irritant
Sensitising
Carcinogenic
Mutagenic
Toxic for reproduction
```
150
What other adverse effects may chemical have?
Environmental effects
151
Which chemicals are not subject to CLP regulation? Give some examples of these
Chemicals in the finished state
Medicines/medical devices, vet medicines, food, cosmetics, feeding stuffs)
152
What is the pharmacist's role in the sale/supply of chemicals?
- 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
What is the aim of a label on a chemical;?
Tell users about hazards and provide brief precautionary advice
154
What particulars should be included on the label of a chemical?
- Name, address and tel no of supplier
- Name and quantity of substance
- Product identifiers
- Hazard information (where appropriate)
155
What are the requirements for packaging of chemicals?
- Prevent chemical escaping without being affected itself
- Withstand repeated normal handling
- Child resistant opening if available to public
- Danger warnings
156
What chemicals may chiropodists and podiatrists use in practice?
- Liquid phenol
- Pyrogallol
- Monochloroacetic acid
- Salicylic acid
157
What legislation covers use of poisons?
- If used as medicine - HMR
| - If not - Poisons Act
158
What do the different part of the poisons act cover?
- Parts 1+2: Regulated poisons or explosive precursors
| - Parts 3+4: Reportable poisons or explosive precursors
159
What are the regulations for purchase of regulated substances?
- 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
What records should be made for the purchase of regulated substances?
- 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
When can unauthorised vet medicines be sold/supplied?
Under veterinary cascade
162
What are the storage requirements for regulated and reportable substances?
- Stored alone with no customer access
- Kept away from food items
- Risk assessment before storing/selling
163
What are authorised vet medicinal products?
List of UK products as well as SPCs
164
What are the regulations surrounding VMPs?
Similar to HMP, MA required, manufacture/wholesale/records all still apply
165
What are the VMP distribution categories and who can prescribe from each?
- 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
What are the requirements for vets to prescribe and supply VMPs?
Have to be registered with the RCVS
167
Where can VMPs be supplied from?
Veterinary practice premises registered with the RCVS or registered pharmacy
168
What are the exemptions for a vet being present when handing over a VMP?
- Individual transaction has been approved by vet before supply
- Vet is satisfied that person handing medicine over is competent
169
Who is classed as a suitably qualified person when prescribing vet medicines and what are the requirements?
- Animal medicines advisor
- Can prescribe and supply certain medicines
- Have to pass exam and be registered
170
Who is responsible for the training and registration of an animal medicines advisor?
- Animal Medicines Training Regulatory Authority
| - Vet Skills ltd
171
What medicines are classified as POM-V and why do they require specialist vet knowledge?
- 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
When is a medicine classified as POM-VPS?
- 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
What is covered under POM-V/POM-VPS?
- Products for food-producing animals
- Products requiring special precautions
- Products that may interfere with future diagnosis
- New products
174
What are NFA-VPS medicines used for?
Non-food producing animals
175
What are the exemptions for small pet animals?
- 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
What must be done in the retail supply of VMPs?
- 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
What are the requirements for POM-V/POM-VPS records?
- 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
When should a prescription for a POM-V/POM-VPS be written and not verbal?
If supplier and prescriber are different
179
What are the legal requirements for a veterinary prescription?
- 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
How should VMPs be labelled?
- 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
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What should be done before taking on the role of the responsible pharmacist?
- 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
What is the veterinary cascade?
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
Who can prescribe and dispense under the veterinary cascade?
Only vets can prescribe but pharmacists can dispense against a prescription
184
When can unauthorised vet medicines be sold/supplied?
Under veterinary cascade
185
How did the Health Act alter the Medicines Act?
- 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
What is a body corporate?
Large chains owning multiple pharmacies
187
What is the role of a superintendent?
- All body corporates must have one
- Make sure every pharmacy has a responsible pharmacist
- Look after all pharmaceutical business of body corporate
188
Whose responsibility is it to ensure that there is a responsible pharmacist in a pharmacy?
- Superintendent, chief pharmacist or owner (in GPhC registered sites)
- Chief pharmacist (in hospital pharmacies as they are not always registered)
189
Who may have the role of the responsible pharmacist?
- Owner
- Partner
- Registered pharmacist employed there
- Superintendent (smaller body corporates)
190
What must be displayed in a pharmacy?
Responsible pharmacist notice containing name, GPhC no. and statement saying they are in charge
191
What does a pharmacy record contain?
Name and GPhC no. of the responsible pharmacist and the time period which they covered
192
What is the role of the responsible pharmacist?
Responsible for keeping SOPs and records
193
What should be done in the responsible pharmacist's absence?
- Record date and time period
| - Reason is good practice
194
What are the requirements for a pharmacy record?
- Electronic or in writing
- Keep for 5 years
- Daily or continuous entry (NOT IN ADVANCE)
- Alterations identifiable
195
What is the role of the responsible pharmacist in pharmacy procedures?
- 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
What are the requirements for SOPs?
- 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
When should there be a responsible pharmacist and how long can they be absent for?
- When pharmacy is operating (may be outside of opening hours)
- 2 hours per 24 hour period
198
What are the requirements for the absence of a responsible pharmacist?
- Easily contactable and able to return
| - Procedures in place if this is not possible
199
Define supervision
Pharmacist has to be present and able to advise during a transaction
200
What activities require a responsible pharmacist to be in charge and present?
- Clinical/legal check of a prescription
- Sale/supply of P/POMs
- Supply under PGD
- Emergency supply
201
What activities require responsible pharmacist to be in charge and supervising but not physically present?
Assembly process
202
What activities require a responsible pharmacist to be in charge but not present or supervising?
- Sale of GSL
| - Processing of waste stock/patient returned medicines
203
What activities do not require a responsible pharmacist?
- Stock orders
- Receiving stock
- Putting away stock
- Date checking
- Receiving prescriptions
- Delivering checked prescriptions and medication
204
What should be done before taking on the role of the responsible pharmacist?
- 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
What are the premises/supervision requirements for the sale and supply of medicines?
Sale in registered premises
Sale and supply under supervision of pharmacist
UNLESS GSL
206
What is a retail pharmacy?
- Premises registered with the GPhC or PSNI
- Business which consists of the retail sale of medicines
- Responsible pharmacist in charge
207
Who may own a retail pharmacy business?
- Individual pharmacist
- Body corporate
- Pharmacist representative
208
In what circumstances can pharmacist representatives carry on a retail pharmacy business?
- Pharmacist has died
- Bankruptcy
- Suffering from mental disorder
209
What are the conditions of a pharmacist representative?
- Have to inform GPhC
- Can continue for 5 years in case of death
- Can continue for 3 years in other cases
210
How do body corporates relate to legal responsibility?
Act together and therefore accept legal responsibility as one
211
What are the requirements for a superintendent of a body corporate?
- 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
