The naranjo adverse drug reactions probability scale is a simple and widely used nonspeci. The severity of each reported adr was assessed using the criterion developed by modified hartwig et al. Naranjo adverse drug reaction probability scale evidencio. Objectives to evaluate agreement between causality assessments of reported adverse drug reactions adrs obtained from decisional algorithms, with those obtained from an expert panel using the who global introspection method gi, according to different levels of imputability and to evaluate the influence of confounding variables. Scale reaction was done by who probability scale w. Published on december 19, 2018 december 19, 2018 14 likes 0 comments. The use of the whoumc system for standardised case causality assessment. The use of the whoumc system for standardised case causality assessment 3 have or any other drug taken. Therefore, a modified naranjo scoring system for causality assessment of adverse events ae was developed. Causality assessment in individual case reports richard hill uppsala, may, 2011. Thehorns drug interaction probability scale dips consists of 10 questions each with three response options to which a score is assigned 37.
Apr 14, 2020 a problematic approach to the causal assessment appears where the guidelines 1 state that in doing causality assessment on an individual case report, it must be remembered that in essence one is conducting a differential diagnosis page 7 and that it is important to recognize that causality assessment of an aefi in an individual patient. Recent studies have questioned the use of naranjo s algorithm and compared new instruments against the superseded naranjo scale. Eskandarian tr 2 effectively using the naranjo scale. Pdf adverse drug reaction and causality assessment scales. Similar to other clinical event monitor studies, computer alert signals with a score of. The scale was also designed for use in controlled trials. Annexure 12 naranjo adverse drug reaction probability.
Criteria used in the naranjo s algorithm are shown in table 1. Objectives define adverse drug reactions discuss epidemiology, classification and causes of adrs describe basic methods to detect, assess, manage and document adrs in the clinical setting describe postmarketing drug safety surveillance, the fda medwatch. Ravi page 1 1 whoumc causality assessmentscale causality term assessment criteriaall 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. Objective was to study the interrater and intrarater agreement in causality assessment of adverse drug reactions between whoumc and naranjo scale. Methods for estimating causal relationships of adverse. The naranjo adr probability scale was developed to help standardize assessment of causality for all adverse drug reactions. These algorithms ranged from 8 questions to 72 questions. The causality assessment of the reported adrs was done using the naranjo causality assessment scale into definite, probable, or possible or doubtful 8. Scale, while there was a higher agreement when using the council for international organizations of medical sciences. Acute liver injury ali induced by paracetamol overdose is a well known cause of emergency hospital admission and death. Naranjo scale, kramers algorithm, karsh and lasagna scale and whoumc causality assessment criteria but the two most widely used are the whoumc and naranjo probability scale. Most commonly used causality assessment scales are naranjo adr probability scale and who. For the assessment of causality between drug and suspected adr, various causality assessment scales been used. Adverse drug reaction and causality assessment scales.
Certain a clinical event, including a laboratory test abnormality, that occurs in a plausible time relation to drug coun 100% chi administration, and which cannot be explained by. However, there is debate regarding the risk of ali after therapeutic dosages of the drug. Since the 20 publication of the causality assessment of an adverse event following immunization aefi, user manual for the revised who classification, there has been extensive global interest in adopting the new revised causality assessment methodology for vaccine pharmacovigilance systems. Naranjo probability scale are the generally accepted and most widely used methods for causality assessment in table 1. The naranjo algorithm, naranjo scale, or naranjo nomogram is a questionnaire designed by. For probable, on the other hand, the event is unlikely to be attributable to another cause. It is an essential part of adr report and important task, conducted by.
Development and validation of a modified naranjo scale for. These scales represent convenient, practical tools for assessing the probability that a given reaction can be. Empirical methods to assess the likelihood that an adr has taken place have. Are there previous conclusion reports on this reaction. The following algorithm has been adapted from published information and may be used as a guide by registrants to conduct causality assessments of adverse experience reports. A method for estimating the probability of adverse drug reactions 1. A method for estimating the probability of adverse drug reactions. Are there previous conclusive reports on this reaction. Naranjo adverse drug reaction probability scale worksheet pdf.
The causality assessment of druginduced liver injury dili remains a challenge and eagerly awaits the development of reliable hepatotoxicity biomarkers. The aim is to describe the characteristics of patients admitted to hospital with jaundice who had previous exposure to therapeutic doses of paracetamol. We modified the naranjo scale by a changing the weightage given to certain responses in the existing naranjo scores b expanding few questions allowing greater clarity for causality assessment c modifying the cutoff scores for classification of aes as definite, probable, possible, doubtful and. Causality or relatedness assessment in adverse drug reaction.
Several methods exist for evaluating causality, including the naranjo scale,12, the food and drug administration fda algorithm,1416 the kramer scale, 17 the liverpool scale18 and the who scale. A total of 302 patients were observed, of which 98 patients experienced adrs, which accounted for 32. Many algorithms have been developed and published in the last forty years from ireys algorithm1972, karch and lasangas method 1977, to the who causality scale and the naranjo scale more recently. Naranjo adverse drug reaction probability scale institutional ethics committee hm patel centre for medical care and education, karamsad page 1 of 1 causality assessment to assess the adverse drug reaction clinical trial protocol no protocol title. Currently, a wide variety of causality assessment scales exist, which attribute clinical events to drugs in individual patients or in case reports. Nov 28, 2017 the causality assessment of druginduced liver injury dili remains a challenge and eagerly awaits the development of reliable hepatotoxicity biomarkers. A number of algorithms or decision aids have been published including the jones algorithm, 11 the naranjo algorithm, 9 the yale algorithm, 12 the karch algorithm, the begaud algorithm, 14 the adrac, 15 the whoumc 16 and a newer quantitative approach algorithm. Ravi page 1 1 whoumc causality assessmentscale causality term assessment criteriaall 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. Did the ae reappear when drugcombination was readministered. This scale was developed to help standardize assessment of causality for all adverse drug reactions and was not designed specifically for drug induced liver injury. Agreement between assessors using the same algorithms was examined, and agreement between the algorithms for the same assessor was also measured.
A study of agreement between the naranjo algorithm and who. Agreement among different scales for causality assessment in. Modified naranjo causality scale for icsrs monarcsi. Nevertheless, causality assessment has become a common routine procedure in pharmacovigilance. Director of pharmacy services glendale adventist medical center, glendale, ca learning objectives methodologies in capturing suspected adrs implement a system in assessing adrs pharmacists role in assessing adrs reporting findings introduction all drugs are dangerous fda drug safety. The same observer assessed all adrs n 9 collected between january 2010 and december 2012 using the who. Recent studies have questioned the use of naranjos algorithm and compared new instruments against the superseded naranjo scale. General features of assessment methods selected methods who probabilistic naranjo algorithmic. The commonly used naranjo scale ns for causality assessment has several limitations and tends to rule in favor of a positive causal effect even when adverse events are unrelated to the drug.
Paracetamol in therapeutic dosages and acute liver injury. Study on the classification, causality, preventability and. Each registrant should conduct a causality assessment for each adverse experience report aer. Adverse drug reaction probability scale naranjo in drug. Algorithms for assessing the probability of an adverse.
Validation of a modified naranjo scale for causality. Method two hundred reports were included in this study. The use of the whoumc system for standardised case. Causality assessment examples of causality algorithms naranjo adverse drug reaction probability scale world health organization, the uppsala monitoring centre whoumc causality assessment system causality outcomes naranjo adr probability scale. It is also called the naranjo scale or naranjo score.
It is also used to evaluate and to check that the particular treatment is the cause of an observed adverse event or not. The causality assessment system proposed by the world health organization collaborating centre for international drug monitoring, the uppsala monitoring center whoumc and the naranjo probability scale are the generally accepted and most widely used methods for causality assessment in clinical practice as they offer a simple methodology. Advances and limitations of standardised case causality assessment what causality assessment can do what causality assessment cannot do. Roussel uclaf causality assessment method scale 72%, j w. Using the naranjo causality scale romic eskandarian, pharm. Evaluation of naranjo adverse drug reactions probability scale in. Causality assessment of adverse drug reaction in pulmonology. The adverse drug reaction adr probability scale was developed in 1991 by naranjo and coworkers from the university of toronto and is often referred to as the naranjo scale. Anyone who has had the opportunity to use an algorithm of 30 questions or above would appreciate the thought process and. Adverse drug reaction and causality assessment scales medind. Probability is assigned via a score termed definite, probable, possible or doubtful.
An example of one of the more commonly used algorithms. Naranjo algoritm systematic causality assessment 10 questions sumscore 63 cases from the literature only 3 authors. Methods for causality assessment of adverse drug reactions. The use of the whoumc system for standardised case causality. Adverse drug reaction probability scale naranjo in drug induced.
Naranjo adverse drug reaction probability scale worksheet pdf 100 kb the naranjo algorithm, or adverse drug reaction probability scale, is a method by which to assess whether there is a causal relationship between an identified untoward clinical event and a drug using a simple questionnaire to assign probability scores. Causality assessment in hepatotoxicity is challenging. The naranjo adverse drug reactions probability scale had low sen. Assessment of causality it is often difficult to decide if an adverse clinical event is an adr or due to deterioration in the primary condition. The causality assessment of dili began more as an art form than a science,7 although the use of early methodologies involving nonorganspecific drug reactions, such as the naranjo scale, are now considered inadequate for determining liverspecific damage. Adapted from the naranjo algorithm, recently a new assessment method was developed known as the liverpool adr causality assessment tool lcat showed high interrater agreement when used by its developers 27,28.
This study was conducted to examine the agreement among different causality assessment scales in. Whoumc causality assessment 2012 clinical safety geek. Roussel uclaf causality assessment method scale is complex and dif. Causality assessment is the assessment of relationship between a drug treatment and the occurrence of an adverse event.
Anyone who has had the opportunity to use an algorithm of 30 questions or above would appreciate the thought process and effort made. The current standard liverspecific council for international organizations of medical sciencesroussel uclaf causality assessment method scale is complex and difficult to implement. In the present study we assessed agreement between the two widely used causality assessment scales, that is, the world health organizationuppsala monitoring center whoumc criteria and the naranjo algorithm. Each reported adr was assessed for its causality by using various scales, namely the who probability scale, naranjo s scale. None of the different available algorithms used for the causality assessment of dili has been universally accepted as the gold standard. The causality assessment system proposed by the world health organization collaborating centre for international drug monitoring, the uppsala monitoring centre whoumc, and the naranjo probability scale are the generally accepted and most widely used methods for causality assessment in clinical practice as they offer a simple methodology. Causality assessment of suspected adverse drug reaction. The naranjo adverse drug reactions probability scale. Background causality assessment in hepatotoxicity is challenging. It is often compared to the whoumc system for standardized causality assessment for. Furthermore, if it is an adr, which medicine caused it, as many patients are on multiple new medications when ill, particularly if admitted to hospital. Annexure 12 naranjo adverse drug reaction probability scale.
The current standard liver specific council for international organizations of medical. Causality assessment of suspected adverse drug reactions 1. A problematic approach to the causal assessment appears where the guidelines 1 state that in doing causality assessment on an individual case report, it must be remembered that in essence one is conducting a differential diagnosis page 7 and that it is important to recognize that causality assessment of an aefi in an individual patient. Causality assessment of suspected adverse drug reaction with. Values obtained from this algorithm are often used in peer.
As a component of the adopted standard operating procedures of the portuguese pharmacovigilance system, the global introspection gi based on the world health organisation scale of imputability2 has been used. The naranjo algorithm, naranjo scale, or naranjo nomogram is a questionnaire designed by naranjo et al. Pdf causality assessment of adverse drug reactions. This algorithm was chosen because its four levels of causality assessment coincide with the causality categories. Critical evaluation of causality assessment of herba drug. These causality assessment scales will be displayed and discussed during this poster presentation. We have therefore attempted to modify the existing ns for better causality assessment. Assessing causality between drug and suspected reaction by. The monarcsi exploratory causality decision support tool is a novel drugevent pair causality assessment. Algorithms for assessing the probability of an adverse drug.
959 1528 1616 110 1432 871 398 519 1607 1351 138 845 76 268 1400 783 1327 597 558 767 533 585 545 980 451 1512 1081 694 49 314 685 1545 1494 1246 1533 583 380 1080 865 1093 812 1366 1289 473 220 1448