non-medicinal products

Question 1

what is a regulated substance

Answer 1

means a regulated explosives precursor or regulated poison

“regulated explosives precursor” is a substance listed in Part 1 of Schedule 1A of the Act

“regulated poison” is a substance listed in Part 2 of Schedule 1A of the Act

Question 2

what is a reportable substance

Answer 2

” means a reportable explosives precursor or reportable poison

“reportable explosives precursor” listed in Part 3 of Schedule 1A

“reportable poison” listed in Part 4 of Schedule 1A

Question 3

what is part 1 ?

Answer 3

Part 1: Regulated Explosive Precursors

May be imported, exported, sold or supplied providing the person doing so has a Home Office licence

hydrogen peroxide, nitric acid, sodium chlorate, potassium chlorate

Question 4

What is part 2

Answer 4

Part 2: Regulated Non-Medicinal Poisons

Purchaser needs a Home Office licence

Can ONLY be sold from a registered pharmacy by or under supervision of a pharmacist

hydrogen cynaide , lead acetate, barium salt

Question 5

what is part 3

Answer 5

Part 3: Reportable Explosive Precursors

Do not require the purchaser to hold a Home Office Licence

Can be supplied if request is not suspicious and after considering whether more appropriate commercial alternatives and sellers are available

acetone, ammonium nitrate ,hexamine

Question 6

what is part 4

Answer 6

Part 4: Reportable Non-Medicinal Poisons

Can be sold from a pharmacy (without need for supervision)

Do not require the purchaser to hold a Home Office Licence

Can be supplied if request is not suspicious and after considering whether more appropriate commercial alternatives and sellers are available

ammonia, aldicarb

Question 7

how can you apply for home office licence and how long does it last.

Answer 7

Online application via gov.uk website
Must provide evidence of identity, DOB and address
Need to include type and volume of substance and intended use
May need a doctor’s report (health check)
Checks are made by the Home Office (criminal check)
When purchasing, MUST provide EPP and photographic ID

Licence valid for up to 3 years

Question 8

who needs a licence

Answer 8

• general public onlyyy

- business to business is exempt

Question 9

what does the licence do?

Answer 9

Permits the holder to acquire and use the chemicals listed on the EPP( explosive precursor poison) licence

The licence could provide terms and conditions about:
Storage
Use
Maximum quantities
Maximum levels of concentration
Reporting of disappearances or thefts

Question 10

what has to be done when someone comes to the pharmacy to ask for a regulated substance

Answer 10

Before supplying to a member of the public you must:

Check the purchaser has a Home Office Licence and associated photographic ID
Check to see if it is unaltered and in-date
Check whether the licence and photographic ID matches the purchaser
Check substance requested and total quantity match the details on the licence (are they able to use, store or possess the requested substance?)
Record details of the transaction onto the licence
Record the details of the transaction (Part 2 poisons only) in a Poisons Register

Question 11

what is the poison register?

Answer 11

ONLY for PART 2

For Part 2 regulated poisons make an entry into the poisons register:

Date of supply
Name and address of purchaser
Name and quantity of regulated poison
Purpose of purchase
Signature of purchaser

Question 12

when should you not supply regulated substances

Answer 12

No licence with photo ID is produced
The licence is out of date and no longer valid
The licence has been tampered/altered with in some way
The request has come from a third party (unless it is a business)
The request is for a substance not listed on their licence or is exceeding their allowance (amount that can be purchased)
You have reason to suspect that the request is suspicious (also applies to REPORTABLE substances)

Question 13

what should be done if you are suspicious?

Answer 13

-report to anti-terrorist hotline
or
theft -police 101

Question 14

what are offences for the supplier

Answer 14

Not checking for a valid licence or not checking photo ID with the licence before sale / supply

Not entering the details of the transaction on the licence

Not putting the required warning label on the regulated substance (Pharmacies are required to label regulated substances intended for sale to the general public). Must state that:
Acquisition, possession or use by the general public is restricted

Not making a record

Not reporting a suspicious transaction / theft / disappearance

Question 15

what is CLP

Answer 15

• classification, labelling, packaging of substances and mixtures

Requires suppliers to:
Identify hazards of chemicals they supply (classification)
Provide information about the chemicals’ hazards (labelling, SDS)
Package the chemicals safely

Relates to the supply of most chemicals but not all

Does not cover medicines (incl. veterinary), CD’s, 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

Question 16

Classification - pharmacists don’t usually classify the suppliers do but its important to be aware due to diligence
-if you prepare medication - you should know it

labelling - required to put the hazard signs
-should be in english, clear and securely fixed

packaging - 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 (CRC), unless it can be proven that children will not be able to gain access
• chemicals labelled

Question 17

what is COSHH

Answer 17

Control of Substances Hazardous to Health Regulations 2002 (COSHH)

Applies 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 the workplace

-emphasis - employers- safety

Question 18

what substances are hazardous to health under COSHH

Answer 18

Substances in CLP approved supply list
Biological agents (bacteria and other microorganisms)
Dust
Asphyxiants (argon, helium)
Pesticides
Medicines
Nanotechnology

Question 19

what substances are not hazardouras to health under COSHH

Answer 19

Asbestos and lead (their own regulations)
Substances hazardous only because they are radioactive, at high pressure, have explosive or flammable properties (other regulations apply)
Biological agents outside the employer’s control e.g catching an infection from a workmate

Question 20

COSHH what are the 8 basic measures that employees must take

Answer 20

Step 1: assess the risks to health from hazardous substances used in or created by workplace activities

Step 2: consider the risks and decide what precautions are needed

Step 3: prevent or adequately control exposure

Step 4: ensure that control measures are used and maintained properly

Step 5: monitor the 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

Question 21

what is the COSHH risk assessment

Answer 21

Employers must not carry out work which can expose any of their employees to any substance hazardous to health until:
a suitable and sufficient assessment of the risks to employees’ health created by that work has been carried out; and
the 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 the work

Question 22

what is denatured alcohol

Answer 22

Use and supply of alcohols not for human consumption regulated by Denatured Alcohol Regulations 2006

Denatured alcohol (also known as methylated spirits) is alcohol that has been made unsuitable for drinking by the addition of denaturants

Question 23

what are the 3 main categories of alcohol

Answer 23

Completely denatured alcohol (CDA), formerly known as mineralised methylated spirits

Industrial denatured alcohol (IDA), formerly known as industrial methylated spirits

Trade-specific denatured alcohol (TSDA) – unlikely to be seen in pharmacy (commonly used in manufacture of propellants, cosmetics, toiletries, cleaning products…). Requires an authority to receive it by HMRC

Question 24

what is CDA -

Answer 24

With every 100 parts by volume of alcohol mix 3 parts by volume of isopropyl alcohol, 3 parts by volume of methyl ethyl ketone and 1g of denatonium benzoate

Sales not restricted to pharmacies – can be supplied to anyone

No conditions on its use and no restriction in quantity that can be obtained from wholesalers or that supplied

Requires labelling according to CLP regulations

Suitable for heating, lighting, cleaning and general domestic use

Question 25

what is IDA

Answer 25

Grade of alcohol typically used in extemporaneous dispensing
Mixture of 95 parts alcohol, 5 parts wood naphtha

Can only be supplied to those authorised by HMRC as “authorised users” (includes pharmacies) – an ‘authorisation’

An authorised user may also supply IDA to another authorised user (only for use specified in the authorisation)

Pharmacists must see a copy of the authorisation before supply

Unless when a pharmacist supplies IDA for medical use on a prescription or written order from a medical or veterinary practitioner

Pharmacist must hold a copy of users authorisation and retain it for 6 years

Can supply in quantities of less than 20L at any one time (3L if a written order from doctor, dentist, nurse, chiropodist, veterinary surgeon…)

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 the pharmacy

All alcohol-based products should be kept in a locked, flammable cupboard

Question 26

what records must be kept for IDA

Answer 26

On receipt of IDA must record amount received, one copy of supplier’s dispatch record signed as a receipt and given back to supplier, one copy retained on premises

Must make records of sales
Including when receipt of written order from a medical or veterinary prescriber (no records for prescriptions, unless private)

Question 27

Safety data sheet

Answer 27

Must be provided when substances subject to UK Registration, Evaluation, Authorisation and restriction of CHemicals (UK REACH) Enforcement Regulations 2008 are supplied for the first time in connection with work e.g. supply to a doctor for use in his/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 the general public for private use (eg. domestic use)

The aims of UK REACH include:
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 responsible for understanding and managing the risks associated with their use.
To promote the use of alternative methods for the assessment of the hazardous properties of substances.