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Suspected adverse reactions surveillance scheme (SARSS)

OC 394/1

Brief Summary

1. This guidance informs inspectors about the Suspected Adverse Reactions Surveillance Scheme (SARSS) operated by the Veterinary Medicines Directorate (VMD).

Purpose

2.To advise staff on the action to take in respect of incidents of ill-health that are alleged to have been caused by exposure to veterinary medicines such as sheep dips. The scheme does not apply to pesticides and should not be used to report alleged cases of ill health arising from incidents such as crop spraying etc.

Action

3.Individuals who believe they may have suffered an adverse health reaction to a veterinary medicine, should be advised about the scheme and encouraged to report the incident directly to the VMD.

4. As the scheme is voluntary the reporting of incidents cannot be enforced. It should be made clear that the scheme is not connected with health and safety legislation enforced by HSE, though cases of occupational ill health from exposure to veterinary medicines may be reportable under the Reporting of Incidents, Diseases and Dangerous Occurrences Regulations 1995.  Information received by the VMD under SARSS is treated in confidence.

Background

5. The Suspected Adverse Reactions Surveillance Scheme (SARSS) is a voluntary scheme for monitoring reports of suspected adverse reactions to veterinary medicines in both humans and animals in the UK. The scheme is run by the VMD, an Executive Agency of the Department for Environment Food and Rural Affairs (DEFRA).

6. In humans, an adverse reaction to a product may occur when animals are being treated e.g. accidental self-injection whilst vaccinating livestock, or after the treatment has taken place e.g. handling recently treated animals. The scheme covers all species of animals treated with veterinary medicines including farmed livestock, zoo animals and companion animals (pets).

7. A suspected human adverse reaction is defined as an incident in which an individual experiences adverse health effects following exposure to a veterinary medicinal product whether at work or elsewhere. Individuals who think they may have experienced an adverse reaction should be encouraged to seek medical advice and to report the reaction to the SARSS.

8. Anyone can report to the scheme using the hard copy Form MLA252A available from the VMD or by using the VMD’s on-line reporting system (see website address at the end of this guidance).

9. All reported human adverse reactions are considered by the VMD and may be referred to the Appraisal Panel for Human Suspected Adverse Reactions to Veterinary Medicines. This panel consists of independent experts and officials from the VMD, the Department of Health and HSE. The Panel’s role is to evaluate all harmful side effects of exposure, identify any trends or emerging problems and report its findings to the Veterinary Products Committee (VPC).

10. The VPC is an independent committee of experts, which advises Ministers on the safety, quality and efficacy of veterinary medicines. Possible actions include making changes to information on the product label, revising the instructions for use, changing the product packaging or requirements for personal protective equipment or in extreme cases suspending the supply of the product.

Further Information

11. For further advice, copies of reporting forms, and the submission of completed forms MLA252A use the following contact details:

Veterinary Medicines Directorate (Suspected Adverse Reactions Surveillance Scheme)
Freepost KT4503
Woodham Lane, New Haw, Addlestone, Surrey,
KT15 3BR
Telephone number 01932 338427

Feedback

Standard text and generic email address to be inserted by ROG team/CDS.

Contact

Head of Agricultural Health, Education and Employment Section Agriculture & Food Sector.

Updated 2012-03-27