non-medicinal products Flashcards
what is a regulated substance
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
what is a reportable substance
” 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
what is part 1 ?
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
What is part 2
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
what is part 3
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
what is part 4
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
how can you apply for home office licence and how long does it last.
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
who needs a licence
- general public onlyyy
- business to business is exempt
what does the licence do?
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
what has to be done when someone comes to the pharmacy to ask for a regulated substance
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
what is the poison register?
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
when should you not supply regulated substances
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)
what should be done if you are suspicious?
-report to anti-terrorist hotline
or
theft -police 101
what are offences for the supplier
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
what is CLP
- 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
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
what is COSHH
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
what substances are hazardous to health under COSHH
Substances in CLP approved supply list Biological agents (bacteria and other microorganisms) Dust Asphyxiants (argon, helium) Pesticides Medicines Nanotechnology
what substances are not hazardouras to health under COSHH
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
COSHH what are the 8 basic measures that employees must take
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
what is the COSHH risk assessment
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
what is denatured alcohol
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
what are the 3 main categories of alcohol
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
what is CDA -
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
what is IDA
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
what records must be kept for IDA
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)
Safety data sheet
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.
