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Veterinary pharmacovigilance in the United Kingdom is overseen by the Veterinary Medicines Directorate (VMD). [1]
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Veterinary pharmacovigilance in the United Kingdom is overseen by the Veterinary Medicines Directorate (VMD). [1]
The Pharmacovigilance Unit at the VMD monitors adverse events; [2] the monitoring carried out by this unit was previously known as the Suspect Adverse Reaction Surveillance Scheme, and is similar to the Yellow Card Scheme of pharmacovigilance for human medicine. The Pharmacovigilance Unit gathers information about suspected adverse events to veterinary medicines in both animals and humans, including suspected lack of expected efficacy, environmental problems, residues in foodstuffs. Anyone, including animal owners, can report suspected adverse events to the VMD, although veterinary surgeons submit most reports. [3]
The marketing authorisation holder of a medicine, that is, the company that has the licence for the medicine, is legally obliged to inform the VMD of any adverse events which are reported to them. The following must be reported by marketing authorisation holders within 15 days:
All other adverse events must be reported in a Periodic Safety Update Report. All SAEs (to animals and humans) should be reported by veterinary surgeons as this is considered good professional conduct (RCVS Guide to Professional Conduct).
Reporters can submit reports online. Hard copies of the reporting forms can also be requested from the VMD or downloaded and printed from the website.
The reports are monitored and analysed by the Pharmacovigilance team 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.
Pharmacovigilance, also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. The etymological roots for the word "pharmacovigilance" are: pharmakon and vigilare. As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.
An adverse drug reaction (ADR) is an injury caused by taking medication. ADRs may occur following a single dose or prolonged administration of a drug or result from the combination of two or more drugs. The meaning of this term differs from the term "side effect" because side effects can be beneficial as well as detrimental. The study of ADRs is the concern of the field known as pharmacovigilance. An adverse drug event (ADE) refers to any injury occurring at the time a drug is used, whether or not it is identified as a cause of the injury. An ADR is a special type of ADE in which a causative relationship can be shown. ADRs are only one type of medication-related harm, as harm can also be caused by omitting to take indicated medications.
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The Yellow Card Scheme is the UK system for collecting information on suspected adverse drug reactions (ADRs) to medicines. The scheme allows the safety of the medicines and vaccines that are on the market to be monitored.
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EudraVigilance is the European data processing network and management system for reporting and evaluation of suspected adverse reactions to medicines which have been authorised or being studied in clinical trials in the European Economic Area (EEA). The European Medicines Agency (EMA) operates the system on behalf of the European Union (EU) medicines regulatory network.
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