Cited by 11,914Pharmacovigilance and Adverse Drug ReactionsReliability and Agreement in MeasurementPharmaceutical Practices and Patient Outcomes

The DOI matches its Crossref record.

A method for estimating the probability of adverse drug reactions

Naranjo, C A, Busto, U, Sellers, E M, Sandor, P, Ruiz, I, Roberts, E A, Janecek, E, Domecq, C, Greenblatt, D J·1981·Clinical Pharmacology and Therapeutics

DOI 10.1038/clpt.1981.154

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Abstract

The estimation of the probability that a drug caused an adverse clinical event is usually based on clinical judgment. Lack of a method for establishing causality generates large between-raters and within-raters variability in assessment. Using the conventional categories and definitions of definite, probable, possible, and doubtful adverse drug reactions (ADRs), the between-raters agreement of two physicians and four pharmacists who independently assessed 63 randomly selected alleged ADRs was 38% to 63%, kappa (k, a chance-corrected index of agreement) varied from 0.21 to 0.40, and the intraclass correlation coefficient of reliability (R[est]) was 0.49. Six (testing) and 22 wk (retesting) later the same observers independently reanalyzed the 63 cases by assigning a weighted score (ADR probability scale) to each of the components that must be considered in establishing causal associations between drug(s) and adverse events (e.g., temporal sequence). The cases were randomized to minimize the influence of learning. The event was assigned a probability category from the total score. The between-raters reliability (range: percent agreement = 83% to 92%; κ = 0.69 to 0.86; r = 0.91 to 0.95; R(est) = 0.92) and within-raters reliability (range: percent agreement = 80% to 97%; κ = 0.64 to 0.95; r = 0.91 to 0.98) improved (p < 0.001). The between-raters reliability was maintained on retesting (range: r = 0.84 to 0.94; R(est) = 0.87). The between-raters reliability of three attending physicians who independently assessed 28 other prospectively collected cases of alleged ADRs was very high (range: r = 0.76 to 0.87; R(est) = 0.80). It was also shown that the ADR probability scale has consensual, content, and concurrent validity. This systematic method offers a sensitive way to monitor ADRs and may be applicable to postmarketing drug surveillance. Clinical Pharmacology and Therapeutics (1981) 30, 239–245; doi:10.1038/clpt.1981.154

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“For each drug-ADR pair, causality and preventability (categorized as definitely or probably preventable, or not preventable) were assessed using the Naranjo [18] scale and Schumock and Thornton [19] algorithm, respectively.”
Reporting adverse drug reactions on a geriatric ward: a pilot project
Somers, A., Petrović, M., Robays, H., et al. (2003) · European Journal of Clinical Pharmacology · doi:10.1007/s00228-002-0535-5 · Cited by 63
Incidence and Predictors of Adverse Drug Reactions Caused by Drug-Drug Interactions in Elderly Outpatients: A Prospective Cohort Study
Obreli-Neto, P. R., Nobili, A., de Lyra, D. P., et al. (2012) · Journal of Pharmacy & Pharmaceutical Sciences · doi:10.18433/j3cc86 · Cited by 63
Safety of Benzodiazepines in Newborns
Ng, E., Klinger, G., Shah, V. S., et al. (2002) · Annals of Pharmacotherapy · doi:10.1345/aph.1a328 · Cited by 63
Hypersensitivity to tranexamic acid: a wide spectrum of adverse reactions
Imbesi, S., Nettis, E., Minciullo, P. L., et al. (2010) · Pharmacy World & Science · doi:10.1007/s11096-010-9415-8 · Cited by 63
“The total score of our five cases was 9, 6, 8, 10 and 9, respectively, so the causality connection between adverse reaction and tranexamic acid administration was certain in the case 1, 4 and 5 and probable in the remaining two cases [8].”
BackgroundMethod
Carbamazepine-Induced Hyponatremia: Assessment of Risk Factors
Kuz, G. M., & Manssourian, A. (2005) · Annals of Pharmacotherapy · doi:10.1345/aph.1g209 · Cited by 63
Clinical and causality assessment in herbal hepatotoxicity
Teschke, R., Schwarzenboeck, A., Eickhoff, A., Frenzel, C., Wolff, A., & Schulze, J. (2013) · Expert Opinion on Drug Safety · doi:10.1517/14740338.2013.774371 · Cited by 63
“Algorithms include the ad hoc approach based on clinical judgment [86], the WHO global introspection method as the WHO method in short [87], and the Naranjo scale [88]; these methods are liver-unspecific and obsolete for hepatotoxicity assessment [90].”
BackgroundMethodInfluential
A study on adverse drug reactions in a tertiary care hospital of Northeast India
Lihite, R. J., Lahkar, M., Das, S., et al. (2016) · Alexandria Journal of Medicine · doi:10.1016/j.ajme.2016.05.007 · Cited by 63
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Torsades de pointes associated with fluoroquinolones: Importance of concomitant risk factors
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Meperidine Is Alive and Well in the New Millennium: Evaluation of Meperidine Usage Patterns and Frequency of Adverse Drug Reactions
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“This drug usage evaluation is limited by the fact that it is difficult to delineate if ADRs are due to the specific agent, meperidine, or to other causes such as benzodiazepines; therefore, Naranjo scores were calculated for all patients with ADRs.(18) It is also difficult to determine cause and effect.”
BackgroundInfluential
Rhabdomyolysis Causing AV Blockade Due to Possible Atorvastatin, Esomeprazole, and Clarithromycin Interaction
Sipe, B. E., Jones, R. J., & Bokhart, G. (2003) · Annals of Pharmacotherapy · doi:10.1345/aph.1c396 · Cited by 63
Drug-Related Emergency Department Visits in an Elderly Veteran Population
Yee, J. L., Hasson, N. K., & Schreiber, D. H. (2005) · Annals of Pharmacotherapy · doi:10.1345/aph.1e541 · Cited by 63
“Anticoagulants, 10 (15) ACE inhibitors, 3 (4) warfarin (10) fosinopril (1) Antiinfectives, 6 (9) lisinopril (2) amoxicillin/clavulanate (1) β-Blockers, 3 (4) cephalexin (2) atenolol (3) clindamycin (1) Calcium-channel blockers, 3 (4) tobramycin (1) diltiazem (1) trimethoprim/sulfamethoxazole (1) felodipine (1) Chemoth…”
Background
Multiorgan dysfunction and disseminated intravascular coagulation in children receiving lamotrigine and valproic acid
Chattergoon, D. S., McGuigan, M. A., Koren, G., et al. (1997) · Neurology · doi:10.1212/wnl.49.5.1442 · Cited by 63
Idiosyncratic Drug-Induced Haematological Abnormalities
Patton, W. N., & Duffull, S. B. (1994) · Drug Safety · doi:10.2165/00002018-199411060-00006 · Cited by 63
Severe bilateral panuveitis during melanoma treatment by Dabrafenib and Trametinib
Draganova, D., Kerger, J., Caspers, L., & Willermain, F. (2015) · Journal of Ophthalmic Inflammation and Infection · doi:10.1186/s12348-015-0049-9 · Cited by 62
“There are several drugs for which the clinical experience is sufficient to establish a “definite,” “probable,” or “possible” association with uveitis using an algorithm proposed by Naranjo and associates [9].”
Method
Anticonvulsant hypersensitivity syndrome: cross-reactivity with tricyclic antidepressant agents
Seitz, C. S., Pfeuffer, P., Raith, P., et al. (2006) · Annals of Allergy Asthma & Immunology · doi:10.1016/s1081-1206(10)61103-9 · Cited by 62
Herb induced liver injury presumably caused by black cohosh: A survey of initially purported cases and herbal quality specifications
Teschke, R., Schwarzenboeck, A., Schmidt‐Taenzer, W., Wolff, A., & Hennermann, K. (2011) · Annals of Hepatology · doi:10.1016/s1665-2681(19)31536-4 · Cited by 62

Authors: Naranjo, C. A., Busto, U., Sellers, E. M., Sandor, P., Ruiz, I., Roberts, E. A., Janecek, E., Domecq, C., & Greenblatt, D. J.
Affiliations: University of Toronto (CA)
Corresponding author: Naranjo, C A
ORCID: Sellers, E M
Sandor, P
Greenblatt, D J
Venue: Clinical Pharmacology and Therapeutics
Publisher: Wiley
Published: 1981-08
Volume: 30
Issue: 2
Pages: 239-245
ISSN: 0009-9236 (ISSN-L)
1532-6535
DOI: 10.1038/clpt.1981.154
OpenAlex: W2067978628
Cited by: 11,914
References: 0
Citations by year: 2026: 650 · 2025: 601 · 2024: 583 · 2023: 592 · 2022: 750 · 2021: 699 · 2020: 645 · 2019: 564 · 2018: 577 · 2017: 591 · 2016: 516 · 2015: 509 · 2014: 485 · 2013: 473 · 2012: 430
FWCI: 11.57
Type: journal article
Language: en
Open access: closed
Locations: Clinical Pharmacology & Therapeutics (publishedVersion)
PubMed (publishedVersion)
Topics: Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Reliability and Agreement in Measurement
Health Sciences › Medicine › Geriatrics and Gerontology › Pharmaceutical Practices and Patient Outcomes
Keywords: adverse drug reactions, drug causality assessment, probability of causation, inter-rater reliability, temporal sequence, post-marketing surveillance, pharmacovigilance, content validity, concurrent validity
MeSH terms: Evaluation Studies as Topic, Humans, Methods, Pharmacists, Physicians, Probability, Random Allocation, Drug-Related Side Effects and Adverse Reactions

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A method for estimating the probability of adverse drug reactions

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