Risk assessment and veterinary medicines
Introduction
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 a
Practice Standards Scheme.
Section 9.6, which relates to risk assessments, states the following;
“The practice must have undertaken a thorough assessment of the
risks arising from the use of veterinary medicines substances hazardous
to health within the practice (L)’’
The text goes on to explain how and why the risks posed by veterinary
medicines should be assessed;
“The risk to Health & Safety from veterinary medicines and other
substances has to be assessed under the Control Of Substances Hazardous
to Health Regulations 2002 (COSHH).
There is wide variation in risk – many are low to medium risk but
there are some substances in veterinary practice which pose a very
serious risk to health.
Implementing measures to control the exposure to low or medium
risk substances can be adequately achieved when they are assessed by
their therapeutic group/type/route of administration etc. The practice
can set out standard measures to control exposures, for example:
- Injectable anaesthetics;
- Pour-on anthelmintics;
- Steroidal compounds;
- Antibiotics.
Within these groups, practices must identify any specific
medicines or substances that could have longer-term health risks, such
as allergies e.g. Penicillin, or sensitivities e.g. latex
Specific and detailed assessments and the resulting measures to
control exposure must be made for high-risk substances such as:
- Any hormones;
- Oil-based vaccines;
- Cytotoxic drugs;
- Gluteraldehyde disinfectants;
- Micotil (tilmicosin);
- Large animal Immobilon (etorphine);
- Zoonoses’’
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.’’
REACH is a new European Regulation that covers the
Registration, Evaluation, Authorisation and restriction of CHemicals. It
entered into force in 2007. REACH has replaced a number of pieces of older
chemicals' legislation, including the Safety Data Sheet Directive.
Therefore, in the United Kingdom, the requirements for
safety data sheets have moved from The Chemical (Hazard Information and
Packaging for Supply) Regulations (CHIP Regulations) to REACH.
Veterinary (and human) medicines are exempt from some
parts of REACH. In particular, medicinal products for veterinary use within
the scope of Regulation (EC) No. 726/2004, Directive 2001/82/EC 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 of Data
Sheets and can also be found online at
http://www.noahcompendium.co.uk/ Alternatively, SPCs for all veterinary
medicines can be found at:
www.vmd.gov.uk/ProductInformationDatabase/Default.aspx.
SPCs for human medicines used by veterinary surgeons
under the cascade (where there is no licensed
veterinary medicine available) can be found at:
www.emc.medicines.org.uk.
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.
April 2010
Further reading
The REACH legislation can be accessed via the following link;
http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:136:0003:0280:EN:PDF
For details from the Health and Safety Executive (HSE) on REACH
exemptions, please refer to the HSE website via the following link;
http://www.hse.gov.uk/reach/resources/exemptions.pdf
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