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Pharmacy Law and Ethics Ali > Supply of Non-Medicinal Products > Flashcards

Supply of Non-Medicinal Products Flashcards

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1
Q

Regulated substance and a reportable substance

A

is a substance that is included in schedule 1A of the poisons Act; if it is not in this list then not controlled under positions act 1972
-if it is not a poison, then it may be called as a chemical or medicinal product, depending on relevant regulations

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2
Q

Regulated substance definition

A

means a regulated explosives precursor or regulated poison

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3
Q

Regulated expolosives precursor

A

substance listen in Part 1 of Schedule 1 A of the act

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4
Q

Regulated poison

A

Substance listed in Part 2 of Schedule 1A of the act

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5
Q

Reportable substance definiton

A

reportable explosive precursor or reportable poison

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6
Q

reportable explosive precursor

A

listed in part 3 of Schedule 1A

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7
Q

Reportable poison

A

listen in Part 4 of schedule 1A

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8
Q

Part 1: Regulated Explosive Precursor Supply

A

-may be imported, exported, sold or supplied providing the person doing so has a home office licence

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9
Q

Part 2: Regulated Non-Medicinal Poisons supply

A
  • Purchaser needs a home office licence

- can only be sold from a registered pharmacy or by supervision of pharmacist

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10
Q

Part 3 and 4

A

Part 4: can be sold from a pharmacy (without the need for supervision)

  • Do not require purchaser to hold a home office licence
  • Can be supplied if request is not suspicious and after considering whether more appropriate commercial alternative and sellers are available
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11
Q

Regulated Substances licensing

A
  • Need a home office licence to purchase, Explosive precursor and poisons licence
  • online application on gov website
  • must provide identity, DOB and address
  • need to include type and volume of substance with intended use
  • may need a doctors report
  • Checks are made by home office
  • when purchasing, must provide EPP and photographic ID
  • Licence valid for 3 years
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12
Q

Who does having a licence apply to?

A
  • general public only
  • business to business sales are exempt
  • sales of substances restricted by law to professional users are exempt
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13
Q

What does the licence do?

A
  • permits the holder to acquire and use chemicals listed on EPP licence
  • Licence could provide terms and conditions about:
  • storage
  • use
  • max quantities
  • max levels of concentration
  • reporting of disappearances or theft
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14
Q

Offences under the rules

A

It is an offence for a member of the general public to

  • import into GB
  • acquire
  • posses and or
  • use

a regulated substance without a valid EPP

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15
Q

What to do if asked for a regulated substance?

A

Before supplying to member of the public you must:

1) check the purchaser has a home office licence and associated photographic ID
2) Check to see if it is unaltered and in date
3) Check whether licence and photographic ID matches the purchaser
4) Check substance requested and total quantity match the details on licence ( are they able to use, store, posses the requested substance)
5) Record details of the transaction onto licence
6) Record details of transaction (Part 2 poisons only) in a poisons register

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16
Q

Poisons Register

A

For part 2 regulated poisons, entry must be put

1) date of supply
2) name and address of purchaser
3) name and quantity of regulated poison
4) purpose of purchase
5) signature of purchaser

17
Q

Do not supply a regulated substance if:

A
  • no licence with photo ID is produced
  • the licence is out of date and no longer valid
  • licence has been tampered/altered with in one way
  • the request has come from a third party (unless its a business)
  • the request is for a substance not listed on their licence or is exceeding allowance
  • you have reason to suspect that the request is suspicious (also applies to reportable substances)
18
Q

Offences for the supplier

A
  • not checking for a valid licence or not checking photo id with the licence before sale supply
  • not entering details of the transaction on licence
  • not putting required warning label on regulated substance
  • must state: acquisition, possession or use by the general public is restricted
  • not making a record
  • not reporting suspicious transaction/ theft. disappearance
19
Q

CLP and COSHH

A

CLP: classification, labelling and packaging of substances and mixtures
COSHHH: Control of substances hazardous to health regulations

20
Q

CLP Regulations- General

A
  • Relates to the supply of most chemicals but not all
  • Does not cover meds (including veterinary), CDs, food or animal, feeding stuff, cosmetics

aims of regulations:

  • identification of harmful properties of chemicals (hazards) and the communication of this information to users by means of labels and safety data sheets (SDS)
  • To cover hazards to health, safety and the environment both at home and at work
21
Q

what does CLP regulations require supplier to do?

A
  • identify hazards of chemicals they supply (classification)
  • provide info about chemical hazards (labelling, SDS)
  • package the chemicals safely
  • approved classification and labelling guide sets out rules for hazard classification and labelling
22
Q

Inspection and Enforcement

A
  • it is an offence to supply a dangerous or hazardous substance before it is classified
  • where a dangerous substance is supplied in or from a registered pharmacy- GPhC enforced regulations
  • Where supplies are made in any shop - enforcement by local weights and measures authority
  • All other cases - Health and Safety Executive
23
Q

Classification

A
  • pharmacist don’t normally have to classify dangerous substances as this is usually done by supplier
  • must apply due diligence if you supply and label or package chemicals
  • if you supply a mixture of chemicals, then you must classify yourself
24
Q

Labelling

A

Label: required to indicate name of chemical, hazards, how to use and precautions
-labelling guide is used after chemical is classified

25
Q

Labelling requirements

A
  • In plain English, unless supply is to another EU member state
  • Clearly and indelibly marked
  • Securely fixed
26
Q

Safety Data Sheet

A
  • must be provided when subject to registration, evaluation, authorisation and restriction of chemicals (REACH) enforcement regulations 2008 are supplied for the first time in connection with work e.g. supply to a doctor for use in his or her practice, health centre or factories
  • ensures recipient can take any necessary precautions relating to the protection of health and safety at work, and protection of the environment
  • supplier ensures data sheet up to date and revises accordingly
  • not needed when supplies made to general public for private use (eg. domestic use)
27
Q

Packaging

A
  • CLP sets out special requirements for packaging of certain chemicals sold to public
  • it is unlawful to supply a dangerous substance unless it is in a receptacle which is designed, constructed, maintained and closed so as to prevent its escape when handled normally
  • Child resistant closures, unless it can be proven that children will not be able to gain access
  • chemicals which are labelled very toxic, toxic., corrosive, harmful should have a tactile danger sign (for blind and partially sited)
28
Q

COSHH

A
  • applied to a wide range of substances and preparations which have the potential to cause harm to health if they are ingested, inhaled or are absorbed by , or come into contact with, the skin or other body membranes whilst at workplace
  • puts an emphasis on employers (including in hospital or community pharmacies. lab and admin offices) to ensure safety in the workplace when dealing with substances hazardous to health
29
Q

Hazardous to Health under COSHH

A
  • substances in CLP approved supply list
  • biological agents (bacteria and other microorganisms)
  • Dust
  • Asphyxiants
  • Pesticides
  • Meds
30
Q

Non Hazardous to health under COSHH

A
  • Asbestos and lead (have their own regulations)
  • Substances hazardous only because they are radioactive, at high pressure, have explosive or flammable properties
  • Biological agents outside the employers control eg. catching an infection from a workmate
31
Q

COSHH sets high basic measures that employers , and sometimes employees must take

A

Step 1: assess the risks to health from hazardous substances used in or created by workplace activities
Step 2: consider risks and decide what precautions are needed
Step 3: prevent or adequately control exposure
Step 4: ensure control measures are used and maintained properly
Step 5: monitor exposure
Step 6: carry out appropriate health surveillance
Step 7: Prepare plans and procedures to deal with accidents, incidents and emergencies
Step 8: ensure individuals are properly informed., trained and supervised.

32
Q

COSHH risk assessment

A

employers must not carry out work which can expose any of their employees to any substances hazardous to health until:

  • a suitable and sufficient assessment of the risks to employees health created by that work has been carried out
  • and steps needed to comply with the regulations have been identified
  • and those steps have been put into operation

-the purpose of the risk assessment is to enable employers to make valid decisions about the measures needed to prevent or adequately control the exposure of their employees to substances hazardous to health arising from work

33
Q

Denatured Alcohol

A
  • Use and supply for alcohols not for human consumption regulated by denatured alcohol regulations 2006
  • denatured alcohol is alcohol that has been made unsuitable for drinking by the addition of denaturants
34
Q

Three main categories of alcohol

A

1) completely denatured alcohol : formerly known as mineralised methylated spirits
2) Industrial denatured alcohol, formerly known as industrial methylated spirits
3) Trade specific denatured alcohol: unlikely to be seen in pharmacy, commonly used in manufacture of propellants, cosmetics, required an authority to receive it by HMRC

35
Q

CDA

A
  • sales not restricted to pharmacies
  • requires labelling according to CLP regulations
  • Suitable for heating, lighting, cleaning and general domestic use
  • no restriction in quantity that can be obtained from wholesalers or that supplied
36
Q

IDA

A
  • grade of alcohol typically used in extemporaneous dispensing
  • can only be supplied to those authorised by HMRC as authorised users (includes pharmacies)
  • An authorised user may also supply IDA to another authorised user
  • pharmacists must see a copy of authorisation before supply
  • unless when a pharmacist supplied IDA for medical use on a prescription or written order of a medical or vet practitioner
  • pharmacist must have copy of authorisation and keep for 6 years
  • can supply in quantities less than 20L at any one time, 3L written order from doctor, dentist, nurse etc.
  • greater than 20L can only be obtained from a licensed or authorised producer or distributor
  • large stocks should be stored out of public areas of pharmacy
  • All alcohol based products should be kept in a locked, flammable cupboard
37
Q

Records for IDA

A
  • on receipt of IDA, must record amount received, one copy of suppliers dispatch record signed as a receipt and given back to supplier, one copy retained on premises
  • must make record of sales
  • including when receipt of written order from a med or vet prescriber
38
Q

Medical Devices

A

any instrument, apparatus appliance, software, when used alone or in combination to be used on human beings for purpose of:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease
  • diagnosis, prevention, monitoring, treatment, alleviation, compensation or an injury or handicap
  • investigation, replacement or modification of anatomy or of a physiological process
  • control of conception
39
Q

Regulation of Medical devices

A
  • regulated by MHRA
  • manufacturers must ensure their devices are safe and fir for the intended purpose
  • examples include, dressing, thermometers, syringes, stoma care products test kits, inhalers, glucose meters
  • CE marked
  • custom made devices, devices undergoing a clinical investigation and in vitro diagnostic devices are exempted from CE marking

Pharmacy Law and Ethics Ali (21 decks)

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