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Academic literature on the topic 'WHO-UMC SCALE'

Author: Grafiati
Published: 4 June 2025
Last updated: 23 June 2025

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Journal articles on the topic "WHO-UMC SCALE"

1

Sharma, Sushil, Ajay Kumar Gupta, and G. Jyothi Reddy. "Inter-rater and intra-rater agreement in causality assessment of adverse drug reactions: a comparative study of WHO-UMC versus Naranjo scale." International Journal of Research in Medical Sciences 5, no. 10 (2017): 4389. http://dx.doi.org/10.18203/2320-6012.ijrms20174564.

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Background: The causality assessment system proposed by the WHO collaborating centre for international drug monitoring, the Uppsala monitoring centre (WHO-UMC) and the Naranjo probability scale are the generally accepted and most widely used methods for causality assessment. Both these scales are structured, transparent, consistent, and easy to apply with distinct advantages. The PvPI recommends use of WHO-UMC scale while many clinicians prefer Naranjo scale for its simplicity. As both these scales are used very widely in practise, it is important to study the level of agreement among them, to ensure proper interpretation of the causality assessment of the drugs. Objective was to study the inter-rater and intra-rater agreement in causality assessment of adverse drug reactions between WHO-UMC and Naranjo scale.Methods: A total of 200 cases were analyzed by three raters. Each ADR reporting form was analyzed by the raters independently using both the Naranjo scale and the WHO-UMC scale. The inter-rater and Intra-rater agreement of all the three raters was analyzed using kappa statistics.Results: The most common category of causality assessment was ‘possible’ which was around 73%, while the probable, definite and unlikely accounted for 23%, 3% and 1% respectively. The inter-rater agreement for the various categories of causality assessment when using Naranjo scale ranged from “very good to excellent” (Kappa value 0.95) while the same ranged from “good to very good” when the WHO-UMC scale was used (Kappa value 0.89) while the Intra-rater agreement for the three raters ranged from good to very good. The mean time (in minutes) taken for assessing the suspected adverse drug an ADR was 8. 26±2.53 for WHO-UMC scale while it was 14.18±3.44 when Naranjo scale was used.Conclusions: Both the WHO-UMC scale and Naranjo scale are reliable and valid tools for causality assessment but the Inter-rater agreement was slightly better with Naranjo as compared to WHO-UMC scale.
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Rehan, H. S., Deepti Chopra, and Ashish Kumar Kakkar. "Causality assessment of spontaneously reported adverse drug events: Comparison of WHO-UMC criteria and Naranjo probability scale." International Journal of Risk & Safety in Medicine 19, no. 4 (2007): 223–27. https://doi.org/10.3233/jrs-2007-420.

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ADRs usually do not present with unique clinical and laboratory findings making it difficult to demarcate them from the concurrent illness. For the estimation of the probability that a drug caused an adverse event several methods have been developed namely, the WHO-UMC criteria, the Naranjo probability scale, the Kramer scale and the Karch and Lasagna scale. But none of the available assessment methods have been shown to produce a precise and reliable quantitative estimation of relationship likelihood. The present study was planned to compare the WHO-UMC causality assessment criteria and the Naranjo probability scale for determining causal relationship between the drug and the event. Randomly 100 Adverse Drug Event (ADE) reports were selected and assessed first by the WHO-UMC criteria and second, by using the Naranjo probability scale. Time needed for evaluation by these methods was also recorded. A disagreement in causality assessment was found in 31% cases (κ=0.214). Mean time taken while using WHO-UMC criteria was 5.3±0.37 minutes vs. 13.26±1.33 minutes while using the Naranjo probability scale. In conclusion disagreement exists amongst the WHO-UMC criteria and the Naranjo probability scale but the former method is simple and less time consuming.
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3

Misra, Saurav, Manmeet Kaur, Tirthankar Deb, et al. "Agreement and correlation between WHO-UMC Causality scale and the Naranjo algorithm for causality assessment of adverse drug reactions at tertiary care center in Northern India." Journal of Family Medicine and Primary Care 14, no. 4 (2025): 1252–58. https://doi.org/10.4103/jfmpc.jfmpc_1148_24.

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Abstract Background: To develop a structured and harmonized causality assessment method has been a holy grail in pharmacovigilance. The Pharmacovigilance Programme of India (PvPI) recommends the use of the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale, whereas many clinicians prefer the Naranjo algorithm for its simplicity. There is no universally accepted method for the causality grading of ADRs. In the present study, we assessed agreement and correlation between the two widely used causality assessment scales, that is, the WHO-UMC criteria and the Naranjo algorithm. Materials and Methods: In this study, 313 individual case safety reports were analyzed from April 1, 2020, to March 31, 2023, reported at the Adverse Drug Reaction Monitoring Center (AMC) at Kalpana Chawla Government Medical College, Karnal. Two well-trained independent groups performed a causality assessment. One group performed a causality assessment of 313 ADRs using the WHO-UMC criteria and the other group performed the same using the Naranjo algorithm. The agreement between two ADR causality scales was assessed using the weighted kappa (κ) test. Spearman’s correlation was also used to find the correlation between the two scales. Results: Cohen’s kappa coefficient (κ) statistical test was applied between the two scales (WHO-UMC scale and Naranjo algorithm) to find out the agreement between these two scales. A weak agreement was found between the two scales (Kappa statistics with 95% confidence interval = 0.463, [P < 0.001]). Spearman’s correlation coefficient was found to be 0.506. Conclusion: The assessment of causality for adverse drug reactions (ADRs) is challenging, and none of the different methods available for assessing ADR causality is accepted as the gold standard. In our study, we found weak agreement between the WHO-UMC criteria and the Naranjo algorithm. It is essential to standardize the causality assessment tool to create a universally acceptable method for assessing causality. Further research is needed to establish a gold standard method for assessing the causality of adverse drug reactions.
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4

Kishore Babu, A. V., and A. Srinivasa Rao. "A Pharmacovigilance Study on Causality and Severity Assessment of Adverse Drug Reactions in a Teaching Hospital." Journal of Drug Delivery and Therapeutics 9, no. 6-s (2019): 44–52. http://dx.doi.org/10.22270/jddt.v9i6-s.3746.

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Objectives: The main purpose of the study is to assess the causality, severity, preventability of ADRs and factors associated with ADRs in chronic disease patients of tertiary care teaching hospital.
 Study setting and Design: A Prospective observational longitudinal study was conducted in a tertiary care teaching hospital at Hyderabad, India, for 3 years.
 Materials and Methods: Patients of age group > 18 years were included in the study. All the patients were distributed according to their gender, age, number medications used, disease condition, and socioeconomic state. The reported ADRs were analyzed by WHO-UMC causality, Hartwig’s Siegel’s scale and modified Shumock and Thornton criteria respectively. Statistical analysis used: Descriptive statistical analysis was used.
 Results: A total of 691 patients enrolled in the study, in that 391 patients reported with 510 ADRs. Of these 37.0% are in-patients and 62.9% are out-patients. Majority of the patients are female category (58.0%) and 45.8% of ADRs reported from adults (41-60 years). 65.8% patients are non-adherent to medication. Life style habits, economic status and education are found to be predictors for ADRs. WHO-UMC scale showed 42.9% of ADRs probable. Hartwig’s and Siegel’s severity scales shown 13.1 % ADRs are severe followed by 33.7% moderate ADRs and 40% of ADRs were preventable.
 Conclusion: Hence our study advises that there is a need of improvement in ADR reporting from health care professionals. This study also suggests further research in India for the improvement of possible intervention strategies to reduce burden and cost of ADR.
 Keywords: Prospective, ADR reporting, WHO-UMC, Hartwig’s Siegel’s scale, Shumock and Thornton.
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5

Sidhu, Harpreet Singh, and Akshay Sadhotra. "Evaluation the pattern of adverse drug reactions by non-steroidal anti-inflammatory drugs at the outpatient orthopedics department of a university teaching hospital in north India." International Journal of Basic & Clinical Pharmacology 7, no. 10 (2018): 1974. http://dx.doi.org/10.18203/2319-2003.ijbcp20183933.

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Background: The study was conducted with an aim to evaluate the pattern of occurrence of adverse drug reactions (ADRs) of Non-steroidal anti-inflammatory drugs (NSAIDs) in orthopedic patients in a tertiary care teaching hospital of North India.Methods: An observational study was carried out in the orthopedic outpatient department at the tertiary care hospital for the period of six months. All patients diagnosed with acute pain and receiving NSAIDs were included. The documented ADRs were assessed for causality, severity and preventability using Naranjo’s algorithm and WHO-UMC scale, modified Hartwig and Seigel Scale and modified Schumock and Thornton scale, respectively.Results: A total of 84 ADRs were reported from 51 patients. The most common ADRs observed were from gastrointestinal (38%) followed by skin (18%) and autonomic nervous system (12%). Maximum number of ADRs were reported in patients on diclofenac (47%) followed by piroxicam (44%). Upon causality assessment, majority of the reactions were possible (61.5% with WHO-UMC scale, and 57.1% with Naranjo’s algorithm). The association of results between the two scales was statistically significant (p<0.001). Majority of ADRs (73.4%) were assessed as mild and 66.7% of the ADRs were probably preventable.Conclusions: Authors conclude that incidence of ADRs can be decreased and compliance can be improved by early detection and management.
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6

Kamdi, Amit S., Pankaj N. Bohra, and Suvarna M. Kalambe. "Ofloxacin-induced maculopapular rash in the infant." International Journal of Basic & Clinical Pharmacology 7, no. 11 (2018): 2261. http://dx.doi.org/10.18203/2319-2003.ijbcp20184185.

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Adverse drug reactions (ADRs) are a major cause of morbidity and mortality in countries having limited healthcare resources. The ofloxacin is an antimicrobial used for treating several bacterial infections. The ofloxacin, belonging to quinolone group of drugs, is bactericidal and acts by inhibition of bacterial DNA gyrase. Among the adverse drug reaction of ofloxacin, skin rashes are rare. An ofloxacin-induced maculopapular rash is the unique rare condition in the infant. The present case report was assessing the causality in ofloxacin induced maculopapular rash in the infant. Naranjo Adverse Drug Reaction Probability Scale and World Health Organization and Uppsala Monitoring Centre (WHO-UMC) system for standardized case causality assessment were used for assessing the causality. According to the Naranjo and WHO-UMC, ofloxacin scaled as the probable/likely cause of this ADR in infant. So, authors can conclude that the ofloxacin should be used cautiously in the pediatric age group.
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7

Kajal, Kumari Arpana. "Comparison of Pharmacovigilance and Herbovigilance Regulatory Guidelines at the Global level." Journal of Pharmacovigilance and Drug Research 4, no. 2 (2023): 13–21. http://dx.doi.org/10.53411/jpadr.2023.4.2.3.

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Pharmacovigilance is the most cutting-edge technology in the medical field, the most advanced technologies in the medical field. It focuses on identifying, evaluating, analyzing, and preventing pharmacological side effects based on identification evaluation analysis and prevention of pharmacological side effects based on long-term and short-term drug exposure. Through the monitoring of drug safety, pharmacovigilance science seeks to enhance patient safety and population welfare. Every nation has regulatory organizations examining case reporting data and examines case reporting data and actual drug-related toxicological concerns. All adverse international unfavourable events in the country are centred at Uppsala Monitoring Centre (UMC). UMC determines judgments based on their investigation connected to numerous aspects of every case report, from Herbovigilance to the Pharmacovigilance drug program. The World Health Organization (WHO) was assisted by UMC when making worldwide decision-making on a global scale.
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8

Kedia, Pulkit R., Netravathi Angadi, and Vikram P. Thondaebhavi. "Adverse drug reaction due to combination of gabapentin and nortriptyline along with its causality assessment." International Journal of Basic & Clinical Pharmacology 11, no. 5 (2022): 494. http://dx.doi.org/10.18203/2319-2003.ijbcp20222150.

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The combination of gabapentin and nortriptyline is used as the first line drug treatment for management of neuropathic pain; however adverse drug reactions (ADRs) are one of the main causes for discontinuation of the therapy. This is a case study of erythematous maculopapular rash induced by combination of gabapentin and nortriptyline along with its causality assessment. A 55-year-old female came with complaint of back pain for 1 month. She was diagnosed as a case of L1 acute osteoporotic disc compression fracture. The patient was then administered combination tablet of gabapentin and nortriptyline (100 mg/10 mg) orally for the neuropathic pain. After 3 days she developed erythematous maculopapular rash on face, upper limbs and back. Following this the drug was then discontinued and pheniramine, hydrocortisone and combination tablet of levocetirizine and montelukast was administered to treat the rashes. Causality assessment was done using the Naranjo scale and WHO UMC assessment scale. The ADRs was reported by VigiFlow in the pharmacovigilance centre. Causality assessment using Naranjo scale (Score 6) and WHO UMC scale indicates probable relationship. Hence, monitoring is essential for any ADRs while using combination of gabapentin and nortriptyline therapy. In case of ADRs, discontinue the therapy and report the adverse drug reactions to pharmacovigilance centre.
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9

Lakhani, Preet, Divya Singh, Shireen Barua, et al. "An observational study to analyze predisposing factors, causality, severity and preventability of adverse drug reactions among multidrug resistant tuberculosis patients treated under RNTCP program in Northern India." International Journal of Research in Medical Sciences 7, no. 3 (2019): 687. http://dx.doi.org/10.18203/2320-6012.ijrms20190918.

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Background: There were 4.1% of all new cases and 19% of previously treated patients were diagnosed with either multidrug resistant or rifampicin resistant tuberculosis in 2016. In the state of Uttar Pradesh, there were 2.16 new cases and 44,531 previously treated cases. The objectives of the study were to assess the predisposing factors, causality assessment, severity grading and avoidability of the adverse drug reactions (ADRs) of the antitubercular drugs in MDR-TB patients in a tertiary care hospital of northern India.Methods: This prospective observational study was conducted for 12 months at a tertiary care hospital. The patients with MDR tuberculosis on treatment with DOTS Plus regimen under RNTCP and who met the inclusion exclusion criteria were recruited after informed consent. ADRs were monitored daily till the patients remained admitted and thereafter monthly. Predisposing factors were recorded. Causality assessment was performed by Naranjo scale and WHO UMC scale, severity by Hartwig’s scale and avoidability by Halla’s scale.Results: There were 115 patients were recruited, 70 developed at least one ADR. 98 ADRs were reported. The commonest ADR reported were – gastrointestinal (38.76%), neurological (21.24%) and hepatobiliary (8.16%). Diabetes and HIV predisposed to development of ADRs. 58.18% ADRs were classified as possible and 37.5% as probable by Naranjo’s scale. 51.02% ADRs were classified as probable and 42.83% as possible by WHO-UMC. 56% were classified as mild, 36% moderate, and 6% severe via Hartwig’s scale. 51 ADRs were classified as avoidable and 40 ADRs were possibly avoidable.Conclusions: Monitoring and assessment of ADRs is necessary to promote awareness, curb resistance and maintain adherence.
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Misra, Saurav, AjayK Shukla, Ratinder Jhaj, ShahN Ahmed, Malaya Nanda, and Deepa Chaudhary. "Agreement between WHO-UMC causality scale and the Naranjo algorithm for causality assessment of adverse drug reactions." Journal of Family Medicine and Primary Care 10, no. 9 (2021): 3303. http://dx.doi.org/10.4103/jfmpc.jfmpc_831_21.

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