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SEVERITY ASSESSMENT OF ADRs – Dr.Renju.S.Ravi
Page 1
1) WHO–UMC CAUSALITY ASSESSMENTSCALE
Causality term Assessment criter...
SEVERITY ASSESSMENT OF ADRs – Dr.Renju.S.Ravi
Page 2
Causality term Assessment criteria(all points shouldbe
reasonably com...
SEVERITY ASSESSMENT OF ADRs – Dr.Renju.S.Ravi
Page 3
2) The term severity is often used to describe the intensity of a med...
SEVERITY ASSESSMENT OF ADRs – Dr.Renju.S.Ravi
Page 4
3) Hartwig et al categorized ADRs into seven levels as per their seve...
SEVERITY ASSESSMENT OF ADRs – Dr.Renju.S.Ravi
Page 5
4) Adverse Drug ReactionProbability Scale (Naranjo)
The AdverseDrug R...
SEVERITY ASSESSMENT OF ADRs – Dr.Renju.S.Ravi
Page 6
While this scale includes all of the usual features that are importan...
SEVERITY ASSESSMENT OF ADRs – Dr.Renju.S.Ravi
Page 7
Adverse Drug Reaction Probability Scale
Question YesNo
Do Not
Know
Sc...
SEVERITY ASSESSMENT OF ADRs – Dr.Renju.S.Ravi
Page 8
Naranjo Algorithm - ADR Probability Scale
Score Interpretationof Scor...
SEVERITY ASSESSMENT OF ADRs – Dr.Renju.S.Ravi
Page 9
Instructions for Using the ADR Probability Scale
The response“Do not ...
SEVERITY ASSESSMENT OF ADRs – Dr.Renju.S.Ravi
Page 10
dechallenge or stopping the medication. The answer “Yes” (+1) applie...
SEVERITY ASSESSMENT OF ADRs – Dr.Renju.S.Ravi
Page 11
Question6. Did the reaction reappear when a placebo was given? This ...
SEVERITY ASSESSMENT OF ADRs – Dr.Renju.S.Ravi
Page 12
applies when there is no information on previous reactions or the in...
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Adverse drug reaction causality assessment
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Causality assessment scales

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ADR ASSESSMENT SCALES

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Causality assessment scales

  1. 1. SEVERITY ASSESSMENT OF ADRs – Dr.Renju.S.Ravi Page 1 1) WHO–UMC CAUSALITY ASSESSMENTSCALE Causality term Assessment criteria(all points shouldbe reasonably complied) Certain  Event or laboratory test abnormality, with plausible time relationship to drug intake  Cannot be explained by diseaseor other drugs  Responseto withdrawalplausible (pharmacologically, pathologically)  Event definitive pharmacologically or phenomenologically (ie. an objective and specific medical disorder or a recognized pharmacologic phenomenon)  Rechallenge satisfactory, if necessary Probable/likely  Event or laboratory test abnormality, with reasonabletime relationship to drug intake  Unlikely to be attributed to diseaseor other drugs  Responseto withdrawalclinically reasonable  Rechallenge not required Possible  Event or laboratory test abnormality, with reasonabletime relationship to drug intake  Could also be explained by disease or other drugs
  2. 2. SEVERITY ASSESSMENT OF ADRs – Dr.Renju.S.Ravi Page 2 Causality term Assessment criteria(all points shouldbe reasonably complied)  Information on drug withdrawalmay be lacking or unclear Unlikely  Event or laboratory test abnormality, with a time to drug intake that makes a relationship improbable(but not impossible)  Diseaseor other drugs provideplausible explanation Conditional/unclassified  Event or laboratory test abnormality  More data for proper assessmentneeded, or  Additional data under examination Unassessable/unclassifiable  Report suggesting an adversereaction  Cannot be judged because information is insufficient or contradictory  Data cannot be supplemented or verified
  3. 3. SEVERITY ASSESSMENT OF ADRs – Dr.Renju.S.Ravi Page 3 2) The term severity is often used to describe the intensity of a medical event, as in grading ‘mild’, ‘moderate’ and ‘severe’. Severity assessment categorizes the ADRs as mild, moderate, or severebased on the based on the steps taken for the management of the ADRs. Karch and Lasagna classified severity into minor, moderate, severeand lethal as defined below: i. Minor: no antidote, therapy or prolongation of hospitalization required. ii. Moderate: requires a changein drug therapy, specific treatment or an increase in hospitalization by at least 1 day. iii. Severe: potentially life threatening, causing permanent damage or requiring intensive medical care. iv. Lethal: directly or indirectly contributes to the death of the patient. The USFDA classifies an ADR as serious when it resultsin death, life- threatening causes, or prolongshospitalization, causesa significant persistent disability, resultsin a congenital anomaly, or requires intervention to prevent permanent damage.
  4. 4. SEVERITY ASSESSMENT OF ADRs – Dr.Renju.S.Ravi Page 4 3) Hartwig et al categorized ADRs into seven levels as per their severity. Level 1 & 2 fall under mild category, level 3 & 4 under moderate and level 5, 6 & 7 fall under category severe. ADR severity assessmentscale (ModifiedHartwig andSiegel) Mild Level 1: The ADR requires no change in treatment with the suspected drug. OR Level 2: The ADRrequires that the suspected drug be withheld, discontinued or otherwisechanged. No antidote or other treatment is required, and there is no increase in lenght of stay. Moderate Level 3: The ADR requires that the suspected drug be withheld, discontinued or otherwisechanged, and/ or an antidote or other treatment is required. There is no increase in lenght of stay. OR Level 4 (a): Any level 3 ADRthat increases lenght of stay by at least one day. OR Level 4 (b): The ADR is the reason for admission. Severe Level 5: Any level 4 ADR that requires intensive medical care. OR Level 6: The ADR causes parmanentharm to the patient. OR Level 7: The ADR either directly or indirectly leads to the death of the patient.
  5. 5. SEVERITY ASSESSMENT OF ADRs – Dr.Renju.S.Ravi Page 5 4) Adverse Drug ReactionProbability Scale (Naranjo) The AdverseDrug Reaction (ADR) Probability Scale was developed in 1991 by Naranjo and coworkers fromtheUniversity of Toronto and is often referred to as the Naranjo Scale. The scale was also designed for use in controlled trials and registration studies of new medications, rather than in routine clinical practice. Nevertheless, it is simple to apply and widely used. Many publications on drug induced liver injury mention results of applying the ADRProbability Scale. The ADR Probability Scale consists of 10 questions that are answered as either Yes, No, or “Do not know”. Differentpoint values (-1, 0, +1 or +2) are assigned to each answer. A simplified version of the 10 questions is provided below:  Are there previous conclusivereports of this reaction?  Did the adverseevent appear after the drug was given?  Did the adversereaction improve when the drug was discontinued or a specific antagonistwas given?  Did the adversereaction reappear upon readministering the drug?  Were there other possiblecauses for the reaction?  Did the adversereaction reappear upon administration of placebo?  Was the drug detected in the blood or other fluids in toxic concentrations?  Was the reaction worsened upon increasing the dose? Or, was the reaction lessened upon decreasing the dose?  Did the patient have a similar reaction to the drug or a related agent in the past?  Was the adverseevent confirmed by any other objective evidence? The actual ADRProbability Scale formand instructions on how it is completed are provided below. Total scores rangefrom -4 to +13; the reaction is considered definite if the scoreis 9 or higher, probable if 5 to 8, possible if 1 to 4, and doubtful if 0 or less.
  6. 6. SEVERITY ASSESSMENT OF ADRs – Dr.Renju.S.Ravi Page 6 While this scale includes all of the usual features that are important in assessing causality, the scale is not weighted for the mostcritical elements in judging the likelihood of drug induced liver injury, such as specific time to onset, criteria for time of recovery, and list of critical diagnoses to exclude, making the scale of limited use in assessing hepatotoxicity. The Naranjo scale also relies upon testing for drug levels, which is rarely helpful in idiosyncratic drug induced liver disease. Finally, the scalewas designed for use in clinical trials, and points are subtracted if the reaction reappears with administration of placebo, which does not apply to the usualcase of drug induced liver disease. Direct comparisons to the RUCAM system haveshown that the ADRProbability Scale is easier to apply, but has less sensitivity and specificity in assigning causality to cases of drug induced liver injury. Naranjo Algorithm - ADR Probability Scale The Naranjo Algorithm, or AdverseDrug Reaction Probability Scale, is a method by which to assess whether there is a causalrelationship between an identified untoward clinical event and a drug using a simple questionnaire to assign probability scores.
  7. 7. SEVERITY ASSESSMENT OF ADRs – Dr.Renju.S.Ravi Page 7 Adverse Drug Reaction Probability Scale Question YesNo Do Not Know Score 1. Are there previousconclusivereportsonthisreaction? +1 0 0 2. Did the adverse eventappearafterthe suspecteddrugwasadministered? +2 -1 0 3. Did the adverse eventimprovewhenthe drugwasdiscontinued oraspecific antagonistwasadministered? +1 0 0 4. Did the adverse eventreappearwhenthe drugwasreadministered? +2 -1 0 5. Are there alternativecausesthatcouldontheirownhave causedthe reaction? -1 +2 0 6. Did the reactionreappearwhen aplacebowasgiven? -1 +1 0 7. Was the drug detectedinbloodorotherfluidsinconcentrationsknownto be toxic? +1 0 0 8. Was the reactionmore severe whenthe dose wasincreasedorlesssevere whenthe dose wasdecreased? +1 0 0 9. Did the patienthave a similarreactiontothe same or similardrugsinany previousexposure? +1 0 0 10. Was the adverse eventconfirmedbyanyobjective evidence? +1 0 0 Total Score:
  8. 8. SEVERITY ASSESSMENT OF ADRs – Dr.Renju.S.Ravi Page 8 Naranjo Algorithm - ADR Probability Scale Score Interpretationof Scores Total Score >9 Definite. Thereaction (1) followed a reasonabletemporal sequence after a drug or in which a toxic drug level had been established in body fluids or tissues, (2) followed a recognized responseto the suspected drug, and (3) was confirmed by improvement on withdrawing the drug and reappeared on reexposure. Total Score 5 to 8 Probable. The reaction (1) followed a reasonabletemporal sequence after a drug, (2) followed a recognized responseto the suspected drug, (3) was confirmed by withdrawalbut not by exposure to the drug, and (4) could not be reasonably explained by the known characteristics of the patient’s clinical state. Total Score 1 to 4 Possible. Thereaction (1) followed a temporal sequence after a drug, (2) possibly followed a recognized pattern to the suspected drug, and (3) could be explained by characteristics of the patient’s disease. Total Score ≤0 Doubtful. The reaction was likely related to factors other than a drug.
  9. 9. SEVERITY ASSESSMENT OF ADRs – Dr.Renju.S.Ravi Page 9 Instructions for Using the ADR Probability Scale The response“Do not know” should be used sparingly and only when the quality of the data does not permit a “Yes” or “No” answer. “Do notknow” can be applicable if the information is not available and also if the question is inapplicable to the case. When more than one drug is involved or suspected, the ADR Probability Scale is usually applied separately to each of the possibleetiologic agents, and the drug with the highest scoreshould be considered the causative agent. In addition, the potential of interaction should be evaluated. Question1. Arethere previous conclusive reports on this reaction? The answer “Yes” (+1) applies if there have been two or more published reports in which the adversereaction has been described in detail or if the adversereaction is listed in a reliable source, such as a medical textbook, review article on the medication or on adversedrug reactions, or the productpackage insert. The response“No” applies when the adverseevent has not been described previously or if only one reporthas been published, or if published reports wereconsidered inconclusive or unconvincing. The answer “Do not know” is applicable only when there is no information, because the agent has not been available for an adequate period of time or has not been previously evaluated for this adversereaction. The scores given for “No” and “Do not know” are the same (0), so it is not critical to decide between these two answers. Question2. Did the adverseevent appear after the suspected drug was administered? This question evaluates the temporal relationship between the reaction and administration of the medication. The answer “Yes” (+2) applies if there is definitive evidence that the adverseevent occurred after the medication was started. “No” (-1) applies when the adverseevent developed before the first doseof the drug. “Do not know” (0) applies if the information is not available or is unclear. Question3. Did the adverseevent improvewhen the drug was discontinued or a specific antagonistwas administered? This question evaluates the responseto
  10. 10. SEVERITY ASSESSMENT OF ADRs – Dr.Renju.S.Ravi Page 10 dechallenge or stopping the medication. The answer “Yes” (+1) applies if the adverseevent diminishes or disappears at any time after stopping the medication, or if the reaction disappears upon administration of a specific pharmacologic antagonist(for example, an anticholinergic given for a cholinergic reaction to physostigmine). Theanswer “No” (0) applies if the adverseevent does not improveor improves in responseto a nonspecific therapy or an antidote to another medication or treatment of the underlying disease. The answer “Do not know” (0) applies if the medication was not stopped or the subsequentcourse was unknown, inconclusiveor unclear. Question4. Did the adverseevent reappear when the drug was readministered? This question evaluates the responseto rechallenge or reexposure. An answer of “Yes” (+2) indicates that the medication was stopped, the adverseevent resolved or improved, and there was an unequivocal reappearanceor worsening of the reaction when the medicine was restarted in a similar doseand by the same route. The Naranjo scale also allows for a “Yes” if the causalassociation is well known and rechallenge cannot be done for clinical or ethical reasons. An answer of “No” (-1) only applies if rechallenge was done, but the adverseevent did not reappear or worsen. The answer “Do not know” (0) applies if rechallenge was not done or information on rechallenge is not available or the reaction was ambiguous. Question5. Arethere alternative causes that could on their own have caused the reaction? This question assesses alternativeexplanations for the adverse event. Because adverseevents are often nonspecific and can be manifestations of the disease being treated or an unrelated, concurrentdiseaseor condition, other diagnoses need to be considered and excluded. The answer “No” (+2) applies if alternative causes havebeen excluded, based upon a systematic and complete evaluation, thus implicating the drug morestrongly. A risk or susceptibility factor is not an alternative cause. The answer “Yes” (-1) applies when there is an alternative cause or explanation. “Do not know” (0) applies if the investigation of other causes is incomplete, inconclusiveor was not done.
  11. 11. SEVERITY ASSESSMENT OF ADRs – Dr.Renju.S.Ravi Page 11 Question6. Did the reaction reappear when a placebo was given? This question applies to clinical research studies in which a placebo was administered. The answer “Yes” (-1) applies if the medication was stopped and the adversereaction resolved or improved conclusively, and there was an unequivocal reappearanceof the adverseevent after administration of placebo (single or double blind). The answer “No” (+1) applies if the reaction did not reappear or worsen after administration of placebo. “Do not know” (0) applies if placebo challenge was not done or the results were inconclusive. Question7. Was the drug detected in blood or other fluids in concentrations known to be toxic? This question applies specifically to dosedependent adverse reactions when blood, urine, tissueor other specimen concentrations of the medicine are available. The answer “Yes” (+1) applies if the concentration is in the accepted toxic or supratherapeutic range. “No” (0) applies if the concentration is below the toxic range. The answer “Do not know” (0) applies if drug levels are not available or are inconclusive. Question8. Was the reaction more severe when the dosewas increased or less severewhen the dose was decreased? This question evaluates the doseresponse relationship of medication and the adversereaction. “Yes” (+1) applies if the adverseevent was more severeor worsened when the dose of the medication was increased, or was less severeand improved when the dose was decreased. “No” (0) applies if there was no appreciable change in the severity of the adverseevent with dosemodification. “Do not know” (0) applies if the dose or regimen was not altered or the information was not available or inconclusive. Question9. Did the patient have a similar reaction to the sameor similar drugs in any previous exposure? This question is directed at past medical history of adversereactions to the same or a structurally related drug. “Yes” (+1) applies when there is documentation of a previous similar reaction to the specific drug or a related medication. “No” (0) applies when the patient does not havea previous exposureto the same medicine or when the patient did not develop the adverse reaction in a previous exposureto the same or related drugs. “Do not know” (0)
  12. 12. SEVERITY ASSESSMENT OF ADRs – Dr.Renju.S.Ravi Page 12 applies when there is no information on previous reactions or the information is inconclusive. Question10. Was the adverseevent confirmed by any objective evidence? The final question assesses thequality of the data on which the adverseevent is assessed. “Yes” (+1) indicates that there is laboratory test documentation of the adverseevent or that the event was directly observed by a qualified person (for example, a skin rash described in nursing or physician notes). The answer “No” (0) applies when neither laboratory tests nor direct clinical documentation can verify the reaction. “Do not know” (0) applies if there is no specific information available (no laboratory testing and no clinical description) or the information is inconclusive. The scores given for “No” and “Do not know” are the same (0), so it is not critical to decide between these two answers.
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ADR ASSESSMENT SCALES

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