Law Y2S2 Flashcards Preview

The Pharmacist > Law Y2S2 > Flashcards

Flashcards in Law Y2S2 Deck (189):
1

Where is legislation for medicines set out?

In HMR 2012

2

What does Part 3 of HMR deal with?

Manufacturing and wholesale dealing

3

What does Part 4 of HMR deal with?

Requirement for authorisation

4

What does Part 5 of HMR deal with?

Marketing authorisations

5

What does Part 6 of HMR deal with?

Certification of homeopathic medicinal products

6

What does Part 7 of HMR deal with?

Traditional herbal registration

7

What does Part 9 of HMR deal with?

Borderline products

8

What does Part 10 of HMR deal with?

Exceptions to requirements for marketing authorisations etc

9

What are the main objectives of legislation?

- Ensure efficacy, safety and quality of the medicinal product
- withdrawal from use if any danger comes to light

10

Are authorised products and investigational products covered by legislation?

Yes

11

Define medicinal product

any substance or combination of substances which are:
1. presented as having properties that prevent or treat disease in humans
2. used by / administered to humans

12

Define authorised medicinal product

Product with marketing authorisation certificate of registration and traditional herbal registration

13

Define relevant medicinal product

A medicinal product that isn't a registrable homeopathic or traditional herbal medicinal product BUT has marketing authorisation

14

Define borderline substance

Shouldn't have any pharmacologically active substances or make medicinal claims.

15

Define medical device

Product covered by Medicinal Devices Regulation 2002 - includes sutures, dressings, contact lens care products.

16

What mark do medical devices have?

CE mark

17

What are the licences and certificated available?

- Marketing authorisation
- Certificate of registration
- Traditional herbal registration
- Manufacturers licence
- WDL
- Clinical trial authorisation

18

What do all relevant medicinal products require?

A marketing authorisation

19

In what circumstance was a 'product licence of right' granted?

Given to medicines that were on the market prior to Medicines Act 1968

20

Why is a MA required?

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

What must an application for a MA in the UK include?

1. Name and permanent address
2. Name of medicinal product
3. Detailed specification of product and constituents
4. Evaluation of potential environmental risks
5. Methods of manufacture and quality control
6. Data on - indications, compatibility and clinical studied
7. Pharmacovigilence
8. SPC, package and leaflet
9. Legal category

22

What are the types of application for a MA?

- New active substances
- Abridged substances
- Biological and biotechnological products

23

What must the licensing authority be satisfied with?

- product is safe and efficacious
- facilities for manufacture and quality control are adequate to ensure conformity with specification

24

How long are MAs initially granted for?

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