WHO-UMC causality assessment - Uppsala Monitoring Centre

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How does it work?How the WHO-UMC causality assessment system can be used will be illustrated with theaid of a few real-life case reports. These will be made available on the UMC website in thenear future.1. Meyboom RHB, Royer RJ. Causality Classification in Pharmacovigilance Centres in the EuropeanCommunity. Pharmacoepidemiology and Drug Safety 1992; 1:87-97.2. Meyboom RHB. Causal or Casual? The Role of Causality Assessment in Pharmacovigilance. Drug Safety17(6): 374-389, 1997.3. Edwards IR, Biriell C. Harmonisation in Pharmacovigilance. Drug Safety 10(2): 93-102, 1994.
Summary description of Causality AssessmentTerm Description CommentCertianA clinical event, includinglaboratory test abnormality,occurring in a plausible timerelationship to drugadministration, and whichcannot be explained byconcurrent disease or otherdrugs or chemicals. Theresponse to withdrawal of thedrug (dechallenge) should beclinically plausible. The eventmust be definitivepharmacologically orphenomenologically, using asatisfactory rechallengeprocedure if necessary.It is recognized that this stringent definitionwill lead to very few reports meeting thecriteria, but this is useful because of thespecial value of such reports. It is consideredthat time relationships between drugadministration and the onset and course ofthe adverse event are important in causalityanalysis. So also is the consideration ofconfounding features, but due weight mustplaced on the known pharmacological andother characteristics of the drug productbeing considered. Sometimes the clinicalphenomena described will also be sufficientlyspecific to allow a confident causalityassessment in the absence of confoundingfeatures and with appropriate timerelationships, e.g. penicillin anaphylaxis.Probable/ LikelyA clinical event, includinglaboratory test abnormality,with a reasonable timesequence to administration ofthe drug, unlikely to beattributed to concurrentdisease or other drugs orchemicals, and which followsa clinically reasonableresponse on withdrawal(dechallenge). Rechallengeinformation is not required tofulfil this definition.This definition has less stringent wording thanfor "certain" and does not necessitate priorknowledge of drug characteristics or clinicaladverse reaction phenomena. As stated norechallenge information is needed, butconfounding drug administration underlyingdisease must be absent.PossibleA clinical event, includinglaboratory test abnormality,with a reasonable timesequence to administration ofthe drug, but which could alsobe explained by concurrentdisease or other drugs orchemicals. Information ondrug withdrawal may belacking or unclear.This is the definition to be used when drugcausality is one of other possible causes forthe described clinical event.UnlikelyA clinical event, includinglaboratory test abnormality,with a temporal relationship todrug administration whichmakes a causal relationshipimprobable, and in whichother drugs, chemicals orThis definition is intended to be used whenthe exclusion of drug causality of a clinicalevent seems most plausible.
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WHO-UMC causality assessment - Uppsala Monitoring Centre

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