Risk assessment and veterinary medicines

Along with every other business, those who hold a stock of animal medicines for sale or supply will need to carry out a COSHH risk assessment. But what does this mean in relation to animal medicines? Is a ‘safety data sheet’ needed for each animal medicine? And where can businesses get the information on medicines to undertake a risk assessment?

Advice from the RCVS Practice Standards Scheme – risk assessments and the veterinary medicines perspective

The RCVS publishes its Practice Standards Scheme (Practice Standards Scheme – Professionals (rcvs.org.uk))In the Practice Team module, 16.1.19, it states:

The practice must have undertaken an assessment of the risks arising from the use of veterinary medicines and substances hazardous to health within the practice.’’

The following guidance is given relating to COSHH:

COSHH is the law that requires employers to control substances that are hazardous to health. You can prevent or reduce workers exposure to hazardous substances by:

  • Finding out what the health hazards are
  • Deciding how to prevent harm to health (risk assessment)
  • Providing control measures to reduce harm to health
  • Making sure they are used
  • Keeping all control measures in good working order – Providing information, instruction and training for employees and others
  • Providing monitoring and health surveillance in appropriate cases e.g. anaesthetic gas monitoring
  • Planning for emergencies

Examples given in the standards as hazardous substances are:

  • Veterinary medicines – low risk can be grouped together e.g. antibiotics, high risk should be assessed specifically e.g. carcinogenic substances
  • Cleaning products
  • Agents that can cause allergies e.g. latex, penicillin
  • Infectious agents e.g. bacteria, viruses
  • Substances e.g. dust

 The standards also state:

“A safety data sheet is not a risk assessment. Gathering information from safety data sheets is the first stage in the assessment process of gathering knowledge”

While this advice is aimed at veterinary practices, other businesses, such as animal health distributors and pet shops will also need to go through the risk assessment process.

In order to facilitate the risk assessment process, suppliers will need to have access to information about the veterinary medicinal products which they hold.

Do I need a Safety Data Sheet?

The answer is, it depends, but the important thing to note is that a Safety Data Sheet is not required for every medicine.

In the eyes of the law, there is no such thing as a ‘‘COSHH data sheet.’’ The correct term is “Safety Data Sheet’’ or “REACH safety data sheet.’’

UK REACH is the legislation that replaces the EU REACH Regulation following the UK’s exit from the European Union. UK REACH covers the Registration, Evaluation, Authorisation and restriction of CHemicals. UK REACH was brought into UK law in 2018, and the EU REACH in 2007. EU REACH replaced a number of pieces of older chemicals’ legislation, including the Safety Data Sheet Directive.

Veterinary (and human) medicines are exempt from some parts of REACH. In particular, medicinal products for veterinary use that are supplied in the finished state, intended for the final user are exempt from the requirement to supply a Safety Data Sheet.

Therefore, as long as the veterinary medicine is supplied in its final formulation and packaging for the final consumer, a Safety Data Sheet (SDS) is not required.

So, Safety Data Sheets are not legally required for veterinary medicines and many medicine companies do not produce them.

So how can a risk assessment be done?

Safety Data Sheets should not be confused with the Product Data Sheets and Summary of Product Characteristics (SPCs). Veterinary practices and other suppliers of animal medicines should ensure that they have access to the current version of either the SPC or the Data Sheet for each authorised medicine used or stored in the practice.

These provide all the necessary information to carry out the required risk assessment.

They are available in the current NOAH Compendium App and can also be found online at http://www.noahcompendium.co.uk/. Alternatively, SPCs for all veterinary medicines can be found at: Product Information Database – Home (defra.gov.uk)

SPCs for human medicines used by veterinary surgeons under the cascade (where there is no licensed veterinary medicine available) can be found at: MHRA Products | Home.

It should be noted that the lists mentioned are not exhaustive and practices and other businesses stocking animal medicines should consider their own individual medicine/substance usage.

Further reading

The REACH legislation can be accessed via the following link;

The REACH etc. (Amendment etc.) (EU Exit) Regulations 2020 (legislation.gov.uk)

For details from the Health and Safety Executive (HSE) on REACH exemptions, please refer to the HSE website via the following link;

UK REACH: Scope and exemptions (hse.gov.uk)

September 2021