Is that Adverse Experience Really Expected? Guidelines for Interpreting and Formatting Adverse Experience Information in the United States

Brown, Kristina S.; Sykes, Robbie; Phillips, George L.

doi:10.1177/009286150103500132

Cited by 3 publications

(3 citation statements)

References 2 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…One of the key requirements for pharmacovigilance reporting for most regulatory authorities is the determination of whether or not the adverse reaction was 'expected'. For human medicines, the response to this depends largely on what appears in the company core safety information (CCSI), in current labelling, or in the summary of product characteristics (SPC), depending on where the product is marketed (Castle & Phillips, 1996;Brown et al, 2001). Veterinary medicines lack a formal CCSI although they may have an equivalent referred to using another name, and so expectedness is based on the information that appears on the label, in the product literature or in the SPC.…”

Section: Expectednessmentioning

confidence: 99%

“…Indeed, there is very little guidance of any description for either human or veterinary medicines. The exception is a publication by Brown and her colleagues in 2001 and in this she examines some examples, criteria and contingencies collected from human medicine (Brown et al, 2001) and these can be adapted for use in veterinary medicine pharmacovigilance. Some suggestions, based closely on Brown's publication, are offered for consideration below and these build upon those described above.…”

Section: Expectednessmentioning

confidence: 99%

“…One of the key requirements for pharmacovigilance reporting for most regulatory authorities is the determination of whether or not the adverse reaction was ‘expected’. For human medicines, the response to this depends largely on what appears in the company core safety information (CCSI), in current labelling, or in the summary of product characteristics (SPC), depending on where the product is marketed (Castle & Phillips, 1996; Brown et al. , 2001).…”

Section: Algorithms For Causalitymentioning

confidence: 99%

See 2 more Smart Citations

Veterinary pharmacovigilance. Part 5. Causality and expectedness

Woodward¹

2005

Vet Pharm & Therapeutics

View full text Add to dashboard Cite

In the European Union and elsewhere there is a requirement to ascribe causality to adverse drug reactions which occur in treated animals. In the EU, the ABON system of causality assessment is used but the assignment of causality assigned is not always self evident, and it may be complicated for a variety of reasons. In this paper, the approaches to causality assessment, based on a number of key criteria which examine the administration of the drug in relation to the sequence of ensuing events and the presence of biological plausibility are examined, along with the utility of using algorithms to facilitate this process. Unexpected adverse drug reactions usually require expedited reporting, depending on national or regional regulatory requirements. Again, deciding on what might constitute an expected (or unexpected) adverse reaction, particularly when a product may be intended for use in a number of species, and when within any one species a number of breeds may be treated, is not necessarily a straightforward issue. However, an approach to facilitate the decision- making process, based on a similar approach used in the pharmacovigilance of human medicinal products is discussed.

show abstract

Section: Expectednessmentioning

confidence: 99%

Section: Expectednessmentioning

confidence: 99%

Section: Algorithms For Causalitymentioning

confidence: 99%

See 1 more Smart Citation

Veterinary pharmacovigilance. Part 5. Causality and expectedness

Woodward¹

2005

Vet Pharm & Therapeutics

View full text Add to dashboard Cite

show abstract

Causality in Pharmacovigilance and Expectedness of Adverse Reactions

Woodward¹

2009

Veterinary Pharmacovigilance

View full text Add to dashboard Cite

Pharmacovigilance for Veterinary Medicinal Products

Woodward¹

2018

Regulatory Toxicology in the European Union

View full text Add to dashboard Cite

Collecting and analysing reports of suspected adverse reactions to veterinary medicinal products is an important part of the regulatory process. The information obtained contributes to the body of knowledge of the adverse effects of a veterinary medicine and its constituents, further defines its safety profile and, where necessary, permits alterations to the terms of the marketing authorisation through restrictions or modifications to the terms of the authorisation, including changes to the product label and product literature. In some cases, authorisations may be suspended or revoked if the adverse reactions are deemed to be sufficiently serious or if mitigating measures are impractical. This chapter examines the European Union requirements for veterinary pharmacovigilance and the guidelines that are applicable. It is important to stress that not all adverse drug reactions have a toxicological basis, for example lack of expected efficacy and reactions to biological products. However, others do have a toxicological origin, and some examples of such adverse reactions to veterinary medicinal products in animals and in humans are reviewed.

show abstract

Is that Adverse Experience Really Expected? Guidelines for Interpreting and Formatting Adverse Experience Information in the United States

Cited by 3 publications

References 2 publications

Veterinary pharmacovigilance. Part 5. Causality and expectedness

Veterinary pharmacovigilance. Part 5. Causality and expectedness

Causality in Pharmacovigilance and Expectedness of Adverse Reactions

Pharmacovigilance for Veterinary Medicinal Products

Contact Info

Product

Resources

About