Suspected Adverse Reaction Surveillance Scheme
Encyclopedia
This article is about Veterinary Medicines. For Human Medicines, see the Yellow Card Scheme
.
The Suspect Adverse Reaction Surveillance Scheme used by the Veterinary Medicines Directorate
(VMD) is similar to the Human Yellow Card Scheme
. It is used in the UK to gather information on Suspected Adverse Reactions
(SARs) to veterinary medicines (in animals and humans) and other aspects of veterinary pharmacovigilance
, namely suspected lack of expected efficacy, environmental problems, and residues in foodstuffs which cast doubt on the validity of the withdrawal period of the medicine concerned. SARs can be reported by anyone: most are reported by marketing authorisation holders, followed by veterinary surgeons.
The following must be reported by marketing authorisation holders within 15 days:
All other adverse reactions must be reported in a Periodic Safety Update Report. All SARs (to animals and humans) should be reported by veterinary surgeons (this is a professional duty).
In addition to the Yellow Card (form MLA252A) for SARs in animals and humans, there is a green card (form MLA1) to report environmental incidents, and a blue card (form MLA2) to report suspected residues of antibiotics in milk.
The reports are monitored and analysed by the Suspected Adverse Reactions Surveillance Scheme of the VMD, who make reports to the Veterinary Products Committee. Where the Secretary of State for Environment, Food and Rural Affairs
considers, as a result of the evaluation of veterinary pharmacovigilance data that there is a significant safety concern, the marketing authorisation may be suspended, revoked or varied to restrict the indications, change the distribution category, amend the dose, add a contraindication, or add a new precautionary measure.
Yellow Card Scheme
The Yellow Card Scheme is the UK system for collecting information on suspected Adverse Drug Reactions to medicines. The Scheme was founded in 1964 after the thalidomide disaster, and was developed by Dr Bill Inman....
.
The Suspect Adverse Reaction Surveillance Scheme used by the Veterinary Medicines Directorate
Veterinary Medicines Directorate
The Veterinary Medicines Directorate is an Executive Agency of the Department for Environment, Food and Rural Affairs seeking to protect public health, animal health, the environment and promoting animal welfare by assuring the safety, quality and efficacy of veterinary medicines in the United...
(VMD) is similar to the Human Yellow Card Scheme
Yellow Card Scheme
The Yellow Card Scheme is the UK system for collecting information on suspected Adverse Drug Reactions to medicines. The Scheme was founded in 1964 after the thalidomide disaster, and was developed by Dr Bill Inman....
. It is used in the UK to gather information on Suspected Adverse Reactions
Adverse effect (medicine)
In medicine, an adverse effect is a harmful and undesired effect resulting from a medication or other intervention such as surgery.An adverse effect may be termed a "side effect", when judged to be secondary to a main or therapeutic effect. If it results from an unsuitable or incorrect dosage or...
(SARs) to veterinary medicines (in animals and humans) and other aspects of veterinary pharmacovigilance
Pharmacovigilance
Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines...
, namely suspected lack of expected efficacy, environmental problems, and residues in foodstuffs which cast doubt on the validity of the withdrawal period of the medicine concerned. SARs can be reported by anyone: most are reported by marketing authorisation holders, followed by veterinary surgeons.
The following must be reported by marketing authorisation holders within 15 days:
- Serious SARs (suspected adverse reaction that results in death, is life-threatening, results in significant disability or incapacity, is a congenital anomaly/birth defect, or that results in permanent or prolonged signs in the animals treated)
- Human adverse reactions (a reaction that is noxious and unintended and that occurs in a human being following exposure to a veterinary medicine)
- unintended transmission of an infectious agent through a veterinary medicinal product
All other adverse reactions must be reported in a Periodic Safety Update Report. All SARs (to animals and humans) should be reported by veterinary surgeons (this is a professional duty).
In addition to the Yellow Card (form MLA252A) for SARs in animals and humans, there is a green card (form MLA1) to report environmental incidents, and a blue card (form MLA2) to report suspected residues of antibiotics in milk.
The reports are monitored and analysed by the Suspected Adverse Reactions Surveillance Scheme of the VMD, who make reports to the Veterinary Products Committee. Where the Secretary of State for Environment, Food and Rural Affairs
Secretary of State for Environment, Food and Rural Affairs
The Secretary of State for Environment, Food and Rural Affairs is a UK cabinet-level position in charge of the Department for Environment, Food and Rural Affairs, and the successor to the positions of Minister of Agriculture, Fisheries and Food and Secretary of State for the Environment, Transport...
considers, as a result of the evaluation of veterinary pharmacovigilance data that there is a significant safety concern, the marketing authorisation may be suspended, revoked or varied to restrict the indications, change the distribution category, amend the dose, add a contraindication, or add a new precautionary measure.