supply of non-medicinal products

Question 1

who does the poisons act 1972 apply to?

Answer 1

1) Applies to members of the general public ONLY
2) Business to Business sales are exempt
3) Sales of substances restricted to professional users are exempt

Question 2

Regulated and Reportable Substances are divided into 4 parts. list these 4 parts

Answer 2

1) Part 1: Regulated Explosive Precursors
2) Part 2: Regulated Non-Medicinal Poisons
3) Part 3: Reportable Explosive Precursors
4) Part 4: Reportable Non-Medicinal Poisons

Question 3

what are the regulations surrounding Regulated Explosive Precursors?

Answer 3

1) may be imported, exported, sold or supplied providing the person doing so has a licence
2) MUST hold a Home Office Licence
3) Inspection and enforcement by the police
- hydrogen peroxide 12%, nitric acid >3%, potassium chlorate >40%

Question 4

what are the regulations surrounding Regulated Non-Medicinal Poisons ?

Answer 4

1) can ONLY be sold from a pharmacy
2) Inspection and enforcement by the police
- hydrogen cyanide, lead acetates, oxalic acid >10%

Question 5

what are the regulations surrounding Reportable Explosive Precursors?

Answer 5

1) may be imported, exported, sold or supplied providing the person doing so has a licence
2) Inspection and enforcement by the police
- acetone, hexamine, ammonium nitrate, sodium nitrate

Question 6

what are the regulations surrounding Reportable Non-Medicinal Poisons?

Answer 6

1) can be sold from a pharmacy (without need for supervision)
2) Inspection and enforcement by the police
- barium salts, fromaldehyde, ammonia

Question 7

what do you need to have in order to purchase a regulated substance?

Answer 7

1) Need a Home Office licence to purchase: Explosive Precursor and Poisons licence (EPP)
2) Checks are made by the Home Office, evidence of identity and address, certificate of good standing etc needed to get the license.

Question 8

What does an EPP license allow you to do?

Answer 8

1) Permits the holder to acquire and use the chemicals listed on the EPP licence
2) It is an offence for a member of the general public to Import into GB, Acquire, Possess or Use a regulated substance without a valid EPP licence

Question 9

Where can the supply of Regulated Poisons take place from?

Answer 9

1) Must be from a registered pharmacy
2) Must be lawfully conducting a retail pharmacy business
3) Must be by or under the supervision of a pharmacist

Question 10

what should you do if a costumer comes in asking for a regulated substance?

Answer 10

1) check the purchaser has a home office licence
2) check to see if it is unaltered and in date
3) check ID- supplies cannot be made to third party
4) check substance requested and total quantity match the details on the licence
5) record details of the transaction onto the licence

Question 11

only part 2 regulated poisons have to be entered in the poisons register. list the details that need to be entered in the register

Answer 11

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

Question 12

what should be done about suspicious transactions and requests?

Answer 12

1) suspicious transactions, and thefts need to be reported
how to spot:
2) purchaser not sure about what it is for or how it is used
3) large quantities, repeated requests
4) pay with cash
5) does not want to provide ID

Question 13

how can a pharmacist commit an offence with regards to regulated substances?

Answer 13

1) Not checking for a valid licence or checking photo ID with the licence before sale / supply
2) Not entering the details of the transaction on the licence
3) Not putting the required warning label on the regulated substance
4) Not making a record
5) Not reporting a suspicious transaction / theft / disappearance

Question 14

what is CHIP, CLP and COSHH

Answer 14

1) Chemicals (Hazard Information and Packaging for supply) (CHIP) Regulations 2009 (will be replaced by CLP from 1 June 2015)
2) Classification, Labelling and Packaging of Substances and Mixtures (CLP Regulations) (Poisons that are “chemicals”)
3) Control of Substances Hazardous to Health Regulations 2002 (COSHH)

Question 15

outline the aims of CHIP/CLP regulations

Answer 15

1) Identification of harmful properties of chemicals (hazards) and the communication of this information to users by means of labels
2) To cover hazards to health, safety and the environment both at home and at work
3) Does not cover medicines (incl. veterinary), CD’s, food or animal feeding stuff, cosmetics

Question 16

what does CHIP/CLP regulations require suppliers to do

Answer 16

1) Identify hazards of chemicals they supply (classification)
2) Provide information about the chemicals’ hazards (labelling)
3) Package the chemicals safely

Question 17

Where a dangerous substance is supplied in or from a registered pharmacy who enforces regulations?

Answer 17

1) GPhC enforces the regulations
2) It is an offence to supply a dangerous or hazardous substance before it is classified
3) Where supplies are made in any shop, market stall etc.- local weights and measures authority

Question 18

what CLP pictograms indicate danger?

Answer 18

1) Explosive
2) Extremely or highly flammable,
3) Very toxic, toxic
4) Corrosive
5) Oxidising
6) Irritant, harmful
7) Dangerous to the environment

Question 19

what CLP pictograms indicate risk?

Answer 19

1) Reacts violently to water
2) Irritating to the eyes
3) Harmful if swallowed
4) Sensitising
5) Carcinogenic

Question 20

what is the purpose of a Safety data sheet ?

Answer 20

1) provided when substances subject to Registration , Evaluation, Authorisation and restriction of CHemicals (REACH) Enforcement Regulations 2008 are supplied for the first time in connection with work
2) Ensures recipient can take any necessary precautions relating to the protection of health and safety at work, and protection of the environment
3) Supplier ensures data sheet up to date and revises accordingly
4) Not needed when supplies made to the general public for private use (eg. Domestic use)

Question 21

outline the legislation surrounding the packaging of dangerous substances

Answer 21

1) CHIP sets out special requirements for packaging of certain chemicals sold to public
2) 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
3) child resistant closures (CRC)
4) chemicals which are labelled very toxic, toxic, corrosive, harmful, extremely flammable, or highly flammable should have a tactile danger sign (for blind and partially sighted)

Question 22

outline the legislation surrounding the labelling of dangerous substances

Answer 22

1) Label – required to indicate name of chemical, hazards, how to use and precautions
2) Labelling guide (ACLG) is used after chemical is classified
3) Must be:
In plain English, Clearly and indelibly marked,Securely fixed
4) Label dimension for supply are specified and must be adhered to

Question 23

what substances does COSHH apply to?

Answer 23

1) 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
2) Puts an emphasis on employers to ensure safety in the workplace when dealing with substances hazardous to health

Question 24

list some substances Hazardous to health under COSHH

Answer 24

1) Substances in CHIP approved supply list
2) Biological agents (bacteria and other microorganisms)
3) Dust
4) Asphyxiants (argon, helium)
5) Pesticides
6) Medicines

Question 25

list some substances that are not Hazardous to health under COSHH

Answer 25

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

Question 26

COSHH sets eight basic measures that employers, and sometimes employees must take. outline these 8 measures

Answer 26

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

Question 27

explain why a COSHH risk assessment is required

Answer 27

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

1) a suitable and sufficient assessment of the risks to employees’ health created by that work has been carried out; and
2) the steps needed to comply with the Regulations have been identified; and those steps have been put into operation
3) 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 28

what is denatured alcohol?

Answer 28

1) Denatured alcohol is alcohol that has been made unsuitable for drinking by the addition of denaturants
2) Use and supply of alcohols not for human consumption regulated by Denatured Alcohol Regulations 2006

Question 29

list the 3 different categories of denatured alcohol

Answer 29

1) Completely denatured alcohol (CDA)
2) Industrial denatured alcohol (IDA)
3) Trade-specific denatured alcohol (TSDA) – unlikely to be used in pharmacy (commonly used in manufacture of propellants, cosmetics, toiletries, cleaning products).

Question 30

what is Completely denatured alcohol (CDA)? and what is it used for

Answer 30

1) every 100 parts by volume of alcohol mix 3 parts isopropyl alcohol, 3 parts methyl ethyl ketone and 1g of denatonium benzoate
2) Sales not restricted to pharmacies
3) CLP labelling regulations
4) Suitable for heating, lighting, cleaning and general domestic use
5) No restriction in quantity that can be obtained from wholesalers or that supplied

Question 31

what is Industrial denatured alcohol IDA and what is it used for?

Answer 31

1) Grade of alcohol typically used in extemporaneous dispensing
2) Mixture of 95 parts alcohol, 5 parts wood naphtha
Can only be supplied to those authorised by HMRC as “authorised users”
3) Anyone (including pharmacies) wanting to receive IDA need an authorisation from HMRC
4) An authorised user may also supply IDA to another authorised user
5) Pharmacists must see a copy of the authorisation before supply. unless for medical use on the prescription or order of a medical or veterinary practitioner

Question 32

outline the supply of IDA from a pharmacy.

Answer 32

1) Pharmacist must hold a copy of users authorisation and retain it for 6 years
2) Can supply in quantities of less than 20L at any one time (3L if a written order from doctor, dentist, nurse, chiropodist, veterinary surgeon)
3) Greater than 20L can be obtained from an authorised producer of distributor
4) Large stocks should be stored out of public areas of the pharmacy
5) All alcohol-based products should be kept in a locked, flammable cupboard

Question 33

outline the record keeping process for IDA

Answer 33

1) 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
2) Must make records of sales
3) Including when receipt of written order from a medical or veterinary prescriber (no records for prescriptions, unless private)

Question 34

what is a medical device?

Answer 34

Any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, to be used on human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease, control of conception
- The Medical Devices Regulations 2002

Question 35

what regulatory body governs medical devices

Answer 35

1) Regulated by the MHRA
2) Manufacturers must ensure their devices are safe and fit for the intended purpose- Examples: dressings, thermometers, needles, syringes, BP monitors, Stoma care products, condoms.
3) CE marked (mandatory conformity mark for products placed in the EU market)
4) Custom-made devices, devices undergoing a clinical investigation and in vitro diagnostic devices are exempted from CE marking