Law Y2S2 Flashcards
(189 cards)
1
Q
Where is legislation for medicines set out?
A
In HMR 2012
2
Q
What does Part 3 of HMR deal with?
A
Manufacturing and wholesale dealing
3
Q
What does Part 4 of HMR deal with?
A
Requirement for authorisation
4
Q
What does Part 5 of HMR deal with?
A
Marketing authorisations
5
Q
What does Part 6 of HMR deal with?
A
Certification of homeopathic medicinal products
6
Q
What does Part 7 of HMR deal with?
A
Traditional herbal registration
7
Q
What does Part 9 of HMR deal with?
A
Borderline products
8
Q
What does Part 10 of HMR deal with?
A
Exceptions to requirements for marketing authorisations etc
9
Q
What are the main objectives of legislation?
A
- Ensure efficacy, safety and quality of the medicinal product
- withdrawal from use if any danger comes to light
10
Q
Are authorised products and investigational products covered by legislation?
A
Yes
11
Q
Define medicinal product
A
any substance or combination of substances which are:
- presented as having properties that prevent or treat disease in humans
- used by / administered to humans
12
Q
Define authorised medicinal product
A
Product with marketing authorisation certificate of registration and traditional herbal registration
13
Q
Define relevant medicinal product
A
A medicinal product that isn’t a registrable homeopathic or traditional herbal medicinal product BUT has marketing authorisation
14
Q
Define borderline substance
A
Shouldn’t have any pharmacologically active substances or make medicinal claims.
15
Q
Define medical device
A
Product covered by Medicinal Devices Regulation 2002 - includes sutures, dressings, contact lens care products.
16
Q
What mark do medical devices have?
A
CE mark
17
Q
What are the licences and certificated available?
A
- Marketing authorisation
- Certificate of registration
- Traditional herbal registration
- Manufacturers licence
- WDL
- Clinical trial authorisation
18
Q
What do all relevant medicinal products require?
A
A marketing authorisation
19
Q
In what circumstance was a ‘product licence of right’ granted?
A
Given to medicines that were on the market prior to Medicines Act 1968
20
Q
Why is a MA required?
A
So that a product can be manufactured or assembles, imported or exported and sold or supplied. A medicinal product must be covered by a MA and held by the person responsible.
21
Q
What must an application for a MA in the UK include?
A
- Name and permanent address
- Name of medicinal product
- Detailed specification of product and constituents
- Evaluation of potential environmental risks
- Methods of manufacture and quality control
- Data on - indications, compatibility and clinical studied
- Pharmacovigilence
- SPC, package and leaflet
- Legal category
22
Q
What are the types of application for a MA?
A
- New active substances
- Abridged substances
- Biological and biotechnological products
23
Q
What must the licensing authority be satisfied with?
A
- product is safe and efficacious
- facilities for manufacture and quality control are adequate to ensure conformity with specification
24
Q
How long are MAs initially granted for?
A
5 years - need to be renewed on expiry
25
What records should holders of MAs keep?
- adverse products
- sales / supplies
- sources of all materials
26
Are most medicinal products with a MA licence for used in children?
No - most have only been tested in adults and so use in children is unlicensed
27
What is the new category of MA for children?
Paediatric Use Marketing Authorisation (PUMP)
28
What age range was Bucculam licensed for?
3months - 18y/o
| used to treat severe convulsions and epileptic seizures
29
When was Bucculam licensed for children?
7th September 2011
30
What are the labelling requirements for relevant medicinal products?
- Legible, comprehensible and indelible
- English or English + other languages
- Braille on outer packaging for blind or partially sighted people
31
What are the Schedule 24 outer & immediate packaging information requirements?
1. Name of medicinal product
2. Strength and pharmaceutical form
3. Target audience
4. If it has up to 3 active substances, a common name for each active substance
5. Statement of active substances in product given as number and words per dosage unit or according to administration form for a given volume of weight
6. Pharmaceutical form & contents by weight, volume or doses of product
7. A list of all excipients or a list of excipients known to give effect
8. Method / ROA
9. Space for prescribe dose to be indicated
10. Warning that it should be kept out of children's reach
11. Special warning applicable to the product
12. Expiry date in clear terms
13. Any special storage precautions
14. Precautions relating to disposal
15. Name and address of holder of MA
16. Number of MA
17. Batch number
18. Instructions for use if not POM
32
What is required for labelling blister packs?
1. Name of product
2. Strength and form
3. Who product is for
4. Name of active substances
5. Name of MA holder
6. Expiry date
7. Batch number
33
What are the labelling requirements for paracetamol?
1. Products that contain paracetamol should say that they contain paracetamol
2. ' do not take more than the label says. If you don't better, go to GP'
34
What are the 4 types of manufacturers licence?
1. Manufacturer licence
2. Manufacturer 'specials' licence
3. Manufacturer licence for investigational medicinal product
4. Manufacturer licence exempt advanced therapy products
35
What does a manufacturer licence allow the holder to do?
Manufacturer and/or assemble medicinal products, including export to outside EEA countries and import licensed medicines from countries outside the EEA
36
Define manufacture
Process carried out in making the product but not dissolving, diluting, etc
37
Define assembly
Process of diving, packaging and presenting
38
Can a product be manufactured without a marketing authorisation?
No - has to be covered by a MA held by the manufacture or by a person ordering the product from the manufacturer
39
What is specials licence for?
Unlicensed medicines or imported unlicensed medicinal products from outside the EEA
40
Are pharmacies are exempt from requiring a specials licence?
Yes - they can prepare extemporaneous products
41
The law allows manufacture and supply of medicinal products for patients with special clinical needs...
True
42
Can chiropodists prescribe special medicinal products?
Yes (as a supplementary prescriber)
43
Who can prescribe specials?
```
Doctors,
Dentists,
NIPs,
PIPs,
Supplementary prescribers - pharmacist, nurse, midwife, chiropodist, radiographer, optometrist, dietician
```
44
What are the conditions for specials?
1. Supply to appropriate person for use under supervision of pharmacist in a registered pharmacy, hospital or health centre
2. No advertising
3. Supervision & procedure should meet specified requirement
4. Records should be available for inspection
5. Manufacturer should hold specials licence
45
A prescriber can prescribe a 'special' if a licence medicinal product exists...
False
46
Wholesale supply goes directly to the patient...
False
47
What does wholesale dealing involve?
sale and supply of medicines by larger distributors to pharmacies and by pharmacies to GP surgeries for individual patients
48
A wholesale dealers licence allows the holder to wholesale P, PO, traditional herbal and GSL medicines...
True
49
A WDL allows the holder to import unlicensed medicinal products from countries outside the EEA
False - from inside EEA only
50
Who can a WDL holder distribute medicines to?
1. Holder of a licence relating to those products
2. Holder of equivalent EEA WL
3. Person who can all products by retail or supply in circumstances corresponding to retail sale
4. person who may lawfully administer those products
51
What conditions have to be complied with to hold a WDL?
Staff, premises, equipment & facilities must be adequate for handling, storage and distribution
Records be kept for specified time for recall
52
What is the minimum length of time that distribution records have to be kept for?
5 years
53
When are pharmacists exempt from licensing requirements?
When manufacture takes place on registered pharmacy premises and the manufacture is supervised
54
Medicinal products specially prepared for individuals have to have a licence...
False - exempt from licensing
55
Products manufactured for holders of authorisations are exempt from licensing...
True
56
When does Medicines Act 1968 allow counter prescribing?
Only if the patient is PRESENT in the pharmacy at the time of request
57
What is counter prescribing according to HMR 2012?
A pharmacist recommending a product made up by them
58
When is a licence not needed?
Practitioners Rx
Customers request for self administration or for someone in their care
Assembly in the pharmacy
Stock mixtures - preparations for dispensing
59
What are chemist nostrums?
Pharmacies own name product - they must be prepared on registered premises and must not be advertised
60
Doctors and dentists are allowed to prepare and assemble products for individual patients..
True
61
Nurses and midwives need a licence to assemble for individual patients...
False - they don't need one
62
Do herbalists need a ML or MA?
No - the product is manufactured or assembled by a herbal practitioner
63
When can herbalists give out herbal remedies?
When the patient has been consulted, the herbalist used specialist judgement and on a registered premises
64
Does a manufacturer or MA holder need a licence to market products from licensed premises?
No
65
Group buying by retailer or practitioners needs a licences
False - only need a licence if the group is a separate company
66
When isn't a WDL needed?
When importing products for a specific person or for a product to be exported without alteration
67
Do food and cosmetics needs a licence?
They are generally exempt from licensing under HMR 2012
68
When do food needs licences?
If said to be beneficial for a particular disease or are labelled with dosages
69
When do vitamins need licences?
- Oral administration with no particulars / directions
- Daily adult dose doesn't exceed 2500 units for A, 25µg folic acid, 250 units D and 5µg cyanocobalamin
- Food with added vitamins >daily dosage
70
When do cosmetics need licences?
If they have any antibiotic, >0.004% hormones, hexachlorophane and >1% resorcinol
71
What is an advertisement of medicines?
Anything designed to promote the prescription, supply, sale or use of that product
72
Give examples of forms of advertising
```
Door to door visits
Visits by medical sales reps
Supple of samples
Provision of inducements to prescribe / supply medicinal products by gift, offer or promise of any benefit / bonus
Sponsorship of promotional meetings
Sponsorship of sciencey people
```
73
MHRA are not allowed to look at advertisements before they are issued...
False - they are allowed. All MAs grants for new active substance have their promotional material vetted
74
When is vetting requested?
When a product is reclassified or for products that have breached regulations
75
Who handles advertising complaints?
MHRA and/or regulatory bodies, the outcome is published
76
Which regulatory body is in charge of general advertising complaints?
ASA
77
Which regulatory body is in charge of OTC advertising complaints?
PAGB
78
Which regulatory body is in charge of POMs advertising complaints?
PMCPA
79
What does European legislation contain?
Rules on content of advertising and promotions & requirements for national monitoring
80
Which part of HMR contains general definitions relevant to advertising?
Part 14
81
What is included in the definition of advertisements for medicinal products?
1. Visits by medicinal sales representatives
2. Supply of samples
3. Provision of inducements to provide / supply medicines
4. Sponsorship of meetings
82
What are the quality standards an advert has to comply with?
- Compliance in SPC
- Encouragement of rational use
- Not misleading
83
Unlicensed products can be promoted...
False
84
Claims can go beyond what is specified in SPC...
False
85
How should rational use be encouraged?
In terms of when medicine should be taken, how & the ROA and information presented should be rational and accurate
86
How long should records of advertising be kept?
3 years after the last one
87
POMs can be advertised to the general public...
False - only P and GSL but they have to comply with regulations
88
Vaccines can't be advertised...
They can
89
Reference to other products in an advert is allowed...
False - it is prohibited
90
The advert should encourage reading of PIL...
True
91
Can adverts make comparative claims abasing other products?
No - they can say that it works faster than a standard, but the claim should not be misleading.
92
Can adverts claim that there are no side effects or claim fast action?
They shouldn't suggest that there are no side effects and should be cautious about claims on fast action (only related to a condition where speed of onset is necessary)
93
Does MHRA encourage volume based promotions?
No - sale and supply of large quantities on promotion undermines legislation of pack size restrictions
94
Are internet adverts acceptable?
Yes - as long as they comply with regulations.
95
Are public internet advertisements for POMs allowed?
No - such adverts should only be websites for healthcare professionals
96
What must short form advertisements contain?
Information compatible with product SPC, detailed info can be found on the website
97
What should adverts to person qualified to prescribe contain?
Information relating to SPC - wording must take into account their technical knowledge
98
What is promotional aid?
A form of reminder of advertisement - a non monetary gift for promotional purpose
99
What are the conditions for professional samples?
Supplied on exceptional basis
Limited number of samples of each product in a year
Supply in response to a written request, signed & dated
Suppliers maintain control and accountability
No larger than the smallest presentation available for sales
In line with requirements of article S4 (54) and be marked 'free medicinal sample - not for resale'
100
What conditions must medicine promoters comply with?
They must have adequate training and sufficient scientific knowledge to allow them to give accurate information and they should have a current SPC for each product produced
101
Define herbal medicine
Medicine product where the only active ingredients are herbal substances or herbal preparation
102
What is a herbal substance?
A plant or part of a plant, algae, fungi or lichen or an unprocessed exudate of a plant that is unprocessed
103
What is a herbal preparation?
Herbal substances that have been extracted, distilled, expressed, purified etc
104
What is a traditional herbal registration?
Registration granted by licensing authority
105
What are the types of herbal remedies?
1. Licensed herbal medicines
2. Registered traditional herbal medicines
3. Unlicensed herbal products
4. Non medicine - supplements or cosmetics
106
Which undeclared pharmaceutical ingredients do feline capsules have?
Chlorphenamine, oxetacaine, piroxicam and betametasone
107
In terms of herbal medicines, what does the MA 1968 recognise?
Pharmacists as suppliers of herbal remedies
| 2 types of herbal remedy suppliers (dealers & practitioners)
108
Herbalists are required to be registered with the Health and Care Professionals Council (HCPC)...
False
109
Herbal practitioners are restricted with the herbs they can deal...
False - They can deal any herbs as long as a one-to-one consultation has taken place with the patient being present in the shop
110
Which herbal remedies have been banned by MHRA?
Kava kava - has a risk of hepatotoxicity
| Senecia species - fatal veno-occulusive disease
111
In which case would herbal remedies be banned by MHRA?
If use results in adverse reactions
112
Part 1 herbal medicinal products can be sold in any shop...
False - they are prohibited from sale unless sold in registered pharmacies (they are mainly anthelmintics and irritants)
113
Part 2 herbal medicinal products are restricted to sale in pharmacies...
False - their strength determines where they can be bought
114
What is aconite?
A poisons plant toxic to the heart - can cause serious ADRs
115
Can shop keepers sell Part 1, Part 2, GSL and THMRs?
Nope - can only sell food supplements and cosmetics
116
What are the conditions for THMs registration?
1. Can use without diagnosis, Rx or monitoring
2. Product given at a particular strength / dose
3. Administered externally, orally or by inhalation
4. Must have been in medicinal use for 30 years and in the EU for 15 years
5. Must have sufficient information about traditional use
117
THMs are not covered by a registration scheme...
False - they are covered by THMRS, all registered products are given a THR registration number
118
What are the labelling requirements for THMs?
There must be a statement to specify that they are THR and there should be a statement to direct patients to doctor if symptoms persist or if ADRs occur
119
Do traditional medicinal products have to prove efficacy, safety and quality?
No - they only have to prove safety and quality
120
Do companies that import THMPs from a non EU country need a licence?
Yes - need a wholesaler's import licence
121
Adverts for herbal medicines don't need to specify that they are herbal...
False
122
What is the Product Licence of Right?
Products on the market before the Medicines Act
123
Do homeopathics have therapeutics indications?
No - they can't have any therapeutic indications. They are restricted to oral and external use
124
When was the National Rules Scheme for Medicinal Products introduced?
1 September 2006
125
What is the prefix for homeopathic authorisation numbers?
NR
126
Can pharmacists give out chemicals in retail?
No - need to establish the need for the chemical
127
What is the purpose of chemical classifications?
Allows you to find out how the chemicals can:
Harm you
Harm others
Harm the environment
128
What is the Globally Harmonised System?
A system uses for the classification and labelling of chemicals
129
What does the Europeans Regulation adopt in terms of chemicals?
Adopts UN GHS of classification and labelling of chemicals throughout the EU
130
What does CLP stand for in terms of chemicals?
Classification, labelling an packaging
131
When did CLP regulations come into effect?
Jan 2009 - they replaced CHIP in June 2015
132
What are the categories of danger?
Physiochemical properties
Health effects
Environmental effects
133
What doesn't CLP apply to?
Chemicals in a finished state for use by a final user
134
What is the purpose of a label on a chemical?
For whoever is dealing with the product, the customer should be able to identify any hazards and should be able to give advice on any potential pre-cautions
135
What must be included on a label for a chemical?
Name, address & (telephone number of supplier in EEA)
Name of substance and nominal quantity
Product identifiers
Where applicable : hazard pictograms, signal words, hazards statements, precautionary statements and supplemental information
136
What properties must the packaging have?
Must be able to contain the product, not be affected by the chemical and must be strong enough to withstand normal handling.
Should have child resistant fastening and warning of danger if give to general public
137
Can chiropodists and podiatrists use chemicals in practice?
Yes - they can use chemicals such as liquid phenol, pyrogallol, monochloroacetic acid or salicylic acid
138
If chiropodist chemicals are place on the market what conditions apply?
They are on the market at medicinal devices and should be CE marked
139
Can arsenic and strychnine be used as medicinal products?
Yes - if used as medicines they fall under the Medicines Act and are controlled by HMR 2012
140
When do arsenic and strychnine fall under the Poisons Act 1972?
When used as a non-medicinal poison
141
What are the 2 classes of regulated chemical substances?
Regulated explosive precursors
| Regulated poisons
142
What is required to obtain regulated substances?
an EPP Home Office licence
143
What is needed to apply for a licence for regulated substances?
ID and adress
Certificate of good standing
Doctors report
144
How long is a regulated substance licence valid for and how much does it cost
Valid for up to 3 years
| Costs ~£40
145
What needs to be presented when making a regulated substance purchase?
EPP licence and ID
146
What is an additional warning label needed on regulated substances?
"Acquisition, possession or use by the general public is restricted"
147
What information is needed on the poisons register?
```
Date of sale
Name and address of purchaser
Name and quantity of poison supplied
Purpose for which required
Signature of purchaser
```
148
What are the 2 classes of reportable substances?
Posions
| Precursors
149
How many lists does the Deregulation Act 2015 group poisons and explosive precursors into?
4 lists
150
When are records made for regulated poisons in the register?
For sale or supply
151
Do poisons registers need to include the purpose for which the poison is required?
Yes
152
What is denatured alcohol?
Alcohol that has been made unsuitable for drinking by the addition of denaturants
153
What are the 3 types of denatured alcohol?
Completely denatured alcohol (CDA)
Industrial denatured alcohol (IDA)
Trade specific denatured alcohol (TSDA)
154
What is CDA used for?
Heating, lighting, and general domestic use
155
Who can CDA be supplied to?
Anyone, in any quantity and there are no conditions on its use and no records are needed
156
What is IDA used for?
Industrial purposes as a solvent for external medical application
157
What is added to IDA to make it unsuitable for drinking?
Methanol
158
How many approved formulations are there of TSDA?
11
159
How can retail / hospital pharmacists obtain IDA (or TSDA)?
They need written authorisation from Revenue and Customs to obtain or receive
160
What does the authorisation of IDA state?
What can be received, what it can be used for and any other conditions
161
How long is a IDA authorisation valid for?
Indefinitely unless conditions change
162
What quantities of IDA can pharmacists obtain on receipt of authorisation?
>20 litres from a wholesale dealer
| <20 litres from other authorised users
163
What are the conditions a an authorised user of IDA or TSDA?
Only use as specified in authorisation
Keep records of all dealings
Keep written signed orders from medical practitioners
Provide annual return if requested
Keep stock securely & security is pharmacists responsibility
Local R&C may need special storage
Record results of stock takes & actions taken
164
What must happen on receipt of IDA/TSDA?
1. Record in stock account amount received
2. Note receipt details on suppliers dispatch doc and on own copy
3. Sign one copy as receipt and give back and put the other copy in records
165
Can IDA be supplied to other users?
Only authorised users and the quantity has to be <20 litres
166
What are the conditions of IDA supply to other authorised users?
Keep copy of authorisation
| Only supply for the purpose on the authorisation
167
When can IDA be given to members of the public?
Can be give for medical use and the requisition can come on written order or on Rx - no need for authorisation
168
What quantity of IDA can be given on written order?
Any - but all information should be kept by the pharmacist
169
What must be included on the label for surgical spirits?
'For external use only'
170
What do surgical spirits contain?
Ethanol: 89-95%
Methanol: 1-5%
171
When can duty free spirits be used?
They can be used for medicinal purposes, in the manufacture of any product prescribed by a doctor to be made up by a pharmacist
172
Is isopropyl alcohol denatured?
No - it isn't covered by regulations and there is no requirement for authorisation to receive or supply
173
Can veterinary medicinal products go on the market without a MA?
No - it is illegal
174
Who can prescribe VMPs?
Veterinary surgeons
Pharmacists
Suitably qualified persons
175
What is a POM-V?
PO veterinarian
176
What is a POM-VPS?
Vet and registered qualified person can prescribe
177
What is a NFA-VPS?
Non-food animal
178
What is a AVM-GSL?
Authorised veterinary medicine
179
In which cases does a Vet not have to be present to supply a VMP?
When they have authorised each transaction individually or when they are confident that the person handing over is competent
180
What is an animal medicine advisor?
A person qualified to prescribe and/or supply VMPs under VMR
181
Which organisations train and register SQPs?
AMTRa or Vet Skills Ltd
182
Which categories of medicine can SQPs supply?
POM-VPS that have been prescribed or any NFA-VPS
183
What are CD2-3 classed as in veterinary medicine?
POM-V
184
Can food producing animals have AVM-GSL?
No - they can only have POM-V
185
What is a legal requirements for vets in care of animals?
They have to carry out a clinical assessment of the animal and the animal has to be under their care
186
When are POM-VPS medicines used?
- Prevent / reduce effects of endemic disease
187
When can veterinary medicines be put on the market without a MA?
If they are for small pets - even still only certain medicines
188
What must a RQP prescribing a POM-V, POM-VPS or NFA-VPS ensure?
- Person administering is competent
- They have given advice on safe administration
- Provided info about contraindications
- Provided minimum amount needed
189
How long does a POM-V/POM-VPS record need to be kept?
5 years
