id:"swepub:oai:DiVA.org:su-103987"
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- Caster, OlaStockholms universitet,Institutionen för data- och systemvetenskap,Uppsala Monitoring Centre, Sweden (författare)
Computing limits on medicine risks based on collections of individual case reports
- Artikel/kapitelEngelska2014
Förlag, utgivningsår, omfång ...
- 2014-03-24
- Springer Science and Business Media LLC,2014
- printrdacarrier
Nummerbeteckningar
- LIBRIS-ID:oai:DiVA.org:su-103987
- https://urn.kb.se/resolve?urn=urn:nbn:se:su:diva-103987URI
- https://doi.org/10.1186/1742-4682-11-15DOI
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- Språk:engelska
- Sammanfattning på:engelska
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- AuthorCount:3;
- Background: Quantifying a medicine's risks for adverse effects is crucial in assessing its value as a therapeutic agent. Rare adverse effects are often not detected until after the medicine is marketed and used in large and heterogeneous patient populations, and risk quantification is even more difficult. While individual case reports of suspected harm from medicines are instrumental in the detection of previously unknown adverse effects, they are currently not used for risk quantification. The aim of this article is to demonstrate how and when limits on medicine risks can be computed from collections of individual case reports. Methods: We propose a model where drug exposures in the real world may be followed by adverse episodes, each containing one or several adverse effects. Any adverse episode can be reported at most once, and each report corresponds to a single adverse episode. Based on this model, we derive upper and lower limits for the per-exposure risk of an adverse effect for a given drug. Results: An upper limit for the per-exposure risk of the adverse effect Y for a given drug X is provided by the reporting ratio of X together with Y relative to all reports on X, under two assumptions: (i) the average number of adverse episodes following exposure to X is one or less; and (ii) adverse episodes that follow X and contain Y are more frequently reported than adverse episodes in general that follow X. Further, a lower risk limit is provided by dividing the number of reports on X together with Y by the total number of exposures to X, under the assumption that exposures to X that are followed by Y generate on average at most one report on X together with Y. Using real data, limits for the narcolepsy risk following Pandemrix vaccination and the risk of coeliac disease following antihypertensive treatment were computed and found to conform to reference risk values from epidemiological studies. Conclusions: Our framework enables quantification of medicine risks in situations where this is otherwise difficult or impossible. It has wide applicability, but should be particularly useful in structured benefit-risk assessments that include rare adverse effects.
Ämnesord och genrebeteckningar
- NATURVETENSKAP Matematik hsv//swe
- NATURAL SCIENCES Mathematics hsv//eng
- NATURVETENSKAP Data- och informationsvetenskap Bioinformatik hsv//swe
- NATURAL SCIENCES Computer and Information Sciences Bioinformatics hsv//eng
- Pharmacovigilance
- Pharmacoepidemiology
- Benefit-risk
- Risk-benefit
- Adverse drug reactions
- Adverse drug reaction surveillance
- Post-marketing
- Post-marketing surveillance
- Spontaneous reports
- data- och systemvetenskap
- Computer and Systems Sciences
Biuppslag (personer, institutioner, konferenser, titlar ...)
- Norén, G. NiklasStockholms universitet,Matematiska institutionen,Uppsala Monitoring Centre, Sweden (författare)
- Edwards, I. Ralph (författare)
- Stockholms universitetInstitutionen för data- och systemvetenskap (creator_code:org_t)
Sammanhörande titlar
- Ingår i:Theoretical Biology and Medical Modelling: Springer Science and Business Media LLC111742-4682
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