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MPharm 2 - PH2110 > unit 1 - health & Safety 2 > Flashcards

unit 1 - health & Safety 2 Flashcards

1
Q

When must a supplier label a substance or mixture containing in packaging according to CLP before placing in on the market?

A

Either when:
a substance is classified as hazardous
a mixture contains one or more substances classified as hazardous above a certain threshold

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2
Q

Who defines the content of the label and the organisation of the various labelling elements?

A

CLP

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3
Q

What does the label need to include, according to CLP?

A

The name, address and telephone number of the supplier
The nominal quantity of a substance or mixture in the packages made available to the general public (unless this quantity is specified elsewhere on the package)
Product identifiers
Where applicable, hazard pictograms, signal words, hazard statements, precautionary statements and supplemental information required by other legislation

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4
Q

What is a hazard statement?

A

A phrase that describes the nature of the hazard in the substance or mixture

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5
Q

Give examples of hazard statements

A

Causes serious eye damage
Toxic if swallowed
Toxic to the aquatic life with long lasting effects
May cause allergy or asthma symptoms or breathing difficulties if inhaled

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6
Q

What is a precautionary statement?

A

A phrase that describes recommended measure(s) to minimise or prevent adverse effects resulting from exposure to a hazardous substance or mixture due to its use or disposal

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7
Q

Give examples of precautionary statements

A

Wear eye protection
Do not eat, drink or smoke when using this product
Avoid release to the environment
In case of inadequate ventilation, wear respiratory protection

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8
Q

What is a signal word?

A

If the chemical has a more severe hazard, the label includes the signal word ‘Danger’
In case of less severe hazards, the signal word is ‘Warning’

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9
Q

What three conditions must packaging adhere to?

A

Packaging must be suitable for the contents:
Prevent escape of the chemical
Not be adversely affected by the chemical and
Be strong enough to withstand normal handling

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10
Q

How can packaging be designed to protect children?

A

The packaging for some chemicals must not have a shape or designation likely to attract the active curiosity of children or mislead consumers

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11
Q

What other packaging requirements are needed in some cases?

A

Child resistant closures/fastenings

Tactile warnings

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12
Q

What does REACH stand for?

A 
Registration
Evaluation
Authorisation
and restriction of
Chemicals
Regulation
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13
Q

What is the system for controlling chemicals in the EU?

A

REACH

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14
Q

What is parallel to EU CLP regulations?

A

REACH

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15
Q

When does a company have to register for REACH?

A

Any company manufacturing or importing into the EU a substance on its own, in a preparation (mixture of substances) or intentionally released from articles (finished manufactured goods) at or above 1 tonne per year may have to register it

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16
Q

What is the aims of REACH?

A

To provide a high level of protection of human health and the environment from the use of chemicals
To make the people who place chemicals on the market (the manufacturers and importers) responsible for understanding and managing the risks associated with their use
To allow free movement of substances on the EU market
To enhance innovation in and the competitiveness of the EU chemicals industry
To promote the use of alternative methods for the assessment of the hazardous properties of substances e.g. quantitative structure-activity relationships (QSAR) and read across

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17
Q

What are SDSs?

A

Safety Data Sheets

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18
Q

When do SDSs not have to be provided?

A

Do not have to be provided for certain products for the final user e.g. medicinal products or cosmetics

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19
Q

Why do SDSs not have to be provided if you are selling medicinal products or cosmetics?

A

If you offer or sell dangerous substances or mixtures to the general public and you provide sufficient information to enable users to take the necessary measures as regards safety and the protection of human health and the environment

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20
Q

Which substances need a Safety Data Sheet?

A

Substances of high concern

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21
Q

What is a PBT chemical?

A

Persistent, Bioaccumaltive and Toxic

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22
Q

What is RIDDOR?

A

Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 2013

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23
Q

When does RIDDOR require deaths and injuries to be reported?

A

When:
there has been an accident which caused the injury
the accident was work-related
the injury is of a type which is reportable

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24
Q

What is an accident?

A

A separate, identifiable, unintended incident, which causes physical injury. This specifically includes acts of non-consensual violence to people at work

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25
Q

What must happen to count as an accident?

A

There must be an identifiable external event that causes the injury e.g. a falling object striking someone

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26
Q

Is cumulative exposure to hazards classed as accidents under RIDDOR?

A

No even if they eventually cause injury

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27
Q

How is an accident classed as ‘work-related’?

A

The fact that there is an accident at work premises does not, in itself, mean that the accident is work-related. The work activity itself must contribute to the accident. An accident is ‘work-related’ if any of the following played a significant role:
the way the work was carried out
any machinery, plant, substances or equipment used for the work, or
the condition of the site of premises where the accident happened

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28
Q

What are reportable injuries?

A

Death of any person (regulation 6)
Specified injuries to workers (regulation 4)
Injuries to workers which result in their incapacitation for more than 7 days (regulation 4)
Injuries to non-workers which result in them being taken directly to hospital for treatment, or specified injuries to non-workers which occur on hospital premises (regulation 5)

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29
Q

Which regulations cover dealing with waste medicines?

A

The Controlled Waste Regulations 1992

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30
Q

What are waste medicines from a patient or residential house classified as?

A

Household waste

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31
Q

What are waste medicines from a nursing home classified as?

A

Industrial waste

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32
Q

Who reviewed waste exemptions?

A

Environmental Agency

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33
Q

Which framework exemption states that a pharmacy no longer needs to register an exemption to receive waste medicines (other than substances with a flash point below 21C)

A

Non-Waste Framework Directive (NWFD)

34
Q

What can pharmacies now do if certain conditions are met?

A

Accept back industrial waste medicines (from nursing homes) AND sharps

35
Q

Where can pharmacies accept waste medicines from?

A

ANY source including nursing homes and other healthcare professionals (doctors, dentists, veterinarians, midwives or nurses)

36
Q

What are the conditions for the temporary storage of waste medicines?

A

No more than 5 cubic metres of waste may be stored at any one time
Temporary storage only (no longer than 3 months, as a general rule)
Stored in secure containers

37
Q

Who are still responsible for collecting patient returned waste (nursing homes and other healthcare professionals are classed as patients)?

A

Primary Care Organisation (PCO)

38
Q

What have some LHBs introduced so patients can return sealed sharps boxes from their own personal use?

A

A patient sharps return service

39
Q

What should the de-blistering of a blister strip be seen as?

A

Waste treatment

40
Q

Why should decanting of liquids from bottles be avoided?

A

It falls within the definition of waste treatment

41
Q

Can a blister strip be removed from its inert packaging (the box)?

A

Yes - as long as the product stays in the innermost packet, it’s OK! The medication itself is not exposed, so is not classed as waste treatment

42
Q

Which medicines come under Hazardous Waste Regulations 2005?

A

Cytotoxic/static medicines

Any medicinal product that is toxic, carcinogenic, mutagenic or toxic for reproduction

43
Q

Who issues the guidance around medicines that are dealt with under Hazardous Waste Regulations 2005, as there is no agreed list?

A

RPSGB

44
Q

When should the environmental agency be notified about any waste medicine that has been stored?

A

> 200kg per annum

45
Q

What should not be mixed, if technically and economically feasible?

A

Hazardous and non-hazardous waste

46
Q

Who provides waste bins for waste medicines?

A

Primary Care Organisation (PCO)

47
Q

What is a poison?

A

Any substance included in the Poisons list made under the Poisons Act 1972

48
Q

Is a substance a poison if it not on the Poisons list made under the Poisons Act 1972?

A

No, no matter how toxic or harmful

49
Q

What is a Part 1 poison?

A

One sold by person lawfully conducting pharmacy business at a registered premises under the supervision of a pharmacist

50
Q

What is a Part 2 poison?

A

One sold by listed sellers and through pharmacy. Listed sellers may nominate up to 2 deputies - does not have to be under supervision of a pharmacist

51
Q

Who maintains the Poisons list?

A

Local authority

52
Q

Where must sales of chemicals that are on the Poisons List be made?

A

On registered premises or listed premises

53
Q

What are poison containers and labelling governed by?

A

CLP regulations

54
Q

How many active poison schedules are there?

A

8

55
Q

Describe poison schedule 1

A

They have special restrictions relating to storate, conditions of sale and records of sale

56
Q

Which schedule 1 poisons are subject to extra control?

A

Fluoroacetic acid
Fluoroacetamide sodium
Strychnine

57
Q

What are the conditions of sale of a schedule 1 poison?

A

Buyer must be known to the seller, or the pharmacist employed at the premises where poison is to be sold
If not known, a householders certificate to be completed to certify the purchaser is a responsible person
If the householder is not known then a police officer in charge of a police station endorses the certificate

58
Q

How are records made of Schedule 1 poisons?

A

Poisons register - entry and signed BEFORE supply

59
Q

How long is the poisons register kept for following completion?

A

2 years

60
Q

What may replace a purchaser signature in the poisons register?

A

Signed Order

61
Q

Within what timeframe can an emergency supply of a Schedule 1 poison be made with a Signed Order?

A

72 hours

62
Q

Where should Schedule 1 poisons be stored?

A

Cupboard or drawer exclusively for poisons OR
Separate part of premises to exclude the public OR
A shelf exclusively for poisons with no food beneath it
There are different restrictions for agriculture/horticulture

63
Q

Which Schedule 1 poisons have special restrictions?

A

Strychnine (removed from mole control in September 2006)

Fluoroacetic acid as a rodenticide

64
Q

Describe poison schedule 4

A

Exempts certain substances from poisons regulations

65
Q

Describe poison schedule 5

A

Exempts certain substances from poisons regulations in certain circumstances e.g. aldicarb is part 2 schedule 1, but schedule 5 for horticulture to persons engaged in trade

66
Q

Where are schedules 2, 3, 6 and 7 from the Poisons List?

A

Deleted in 1985!

67
Q

What is IDA?

A

Industrial denatured alcohol

68
Q

What is IDA made from?

A

95 parts alcohol

5 parts wood naptha

69
Q

What is IDA used for?

A

Approved use in industrial, scientific OR external medical application

70
Q

Who must you apply to to receive IDA?

A

HM Revenue and Customs

71
Q

Who must receive authorisation BEFORE they can receive IDA?

A

The supplier (pharmacist)

72
Q

How long is the authority for IDA for?

A

Indefinitely, unless the formulation changes

73
Q

What are pharmacists required to do before stocking IDA?

A

Make an entry of premises

74
Q

How should IDA be stored?

A

Under lock and key by the pharmacist

75
Q

What should an authorised pharmacist do if they want to supply another authorised user?

A

Check user’s authorisation
Ensure the IDA is employed for authorised use
Quantity < 20 litres

76
Q

Under what conditions can a pharmacist also supply medical (including nurses and chiropodists) and veterinary practitioners?

A

Quantity not exceeding 3L
No set format for order (needs quantity and class)
Any ‘medical use’, except internal administration

77
Q

What is Trade Specific Denatured Alcohol (TSDA) used in?

A

Toiletries
Cosmetics
Cleaning materials

78
Q

What is CDA used for?

A

Completely denatured alcohol

For 100 parts alcohol
Mix 3 parts isopropyl alcohol, 3 parts methyl ethyl ketone
1g denatonium benzoate

Heating
Lighting
Cleaning
General domestic use

79
Q

Where can CDA be purchased?

A

A variety of retailers including DIY shops

80
Q

In Scotland, what is the legal age to buy CDA?

A

14 years old

MPharm 2 - PH2110 (15 decks)

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