Comparison of WHO-UMC and Naranjo Scales for Causality Assessment of Reported Adverse Drug Reactions.

OBJECTIVES: The 2 most commonly used scales worldwide are the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) and the Naranjo scales. The present study was planned to assess the degree of agreement between the 2 scales when the same adverse drug reactions (ADR) were assessed by 5 raters independently. METHODS: One hundred individual case safety reports were selected randomly from the ADR database of our institute and the details were emailed to 5 different experts (raters), who were DM Clinical Pharmacology residents from different institutes in India. An independent causality assessment of these ADRs was performed independently by these raters using both the WHO-UMC and Naranjo causality assessment scales. The agreement between the 2 scales was assessed for each rater using Cohen κ, and the overall interrater agreement was assessed using Fleiss κ. RESULTS: The Cohen κ level of agreement between the 2 scales for the 5 raters were substantial, fair, substantial, moderate, and substantial, respectively. The most common causality assessment category as per WHO-UMC scale was "possible" but varied among the raters on the Naranjo scale. No ADR was categorized as "certain" by any rater on the Naranjo scale. The Fleiss κ value for agreement among the 5 raters was found to be 0.2 (slight) for the WHO-UMC scale and 0.297 (fair) for the Naranjo scale. CONCLUSIONS: A moderate level of agreement was observed in this study between the WHO-UMC and Naranjo scales. The level of agreement among these 5 raters was found to be similar for the WHO-UMC and the Naranjo scales, indicating a similar degree of subjectivity for the 2 scales. Hence, more robust and less subjective scales are required for causality assessment.

Impact of educational interventions on pharmacovigilance and adverse drug reaction reporting by resident doctors and faculty members: A prospective comparative study.

Purpose/Aim: Adverse drug reactions (ADRs) are significantly under-reported worldwide. The aim of this study was to assess the impact of educational interventions (EIs) on knowledge, attitude, and practice (KAP) of hospital resident doctors and faculty members and compare ADR reporting in EI (medical specialties) vs. non-EI (surgical specialties) in these two cadres of doctors. Materials and Methods: This study was a prospective comparative study conducted in two groups (EI and non-EI) in resident doctors and faculty members working at a tertiary care hospital. EI group (medical specialties) were provided with EI to increase awareness about ADR reporting, whereas in non-EI group (surgical specialties), no EI was provided and they served as control. Respondents were asked to fill a pretest questionnaire followed by interactive EI in EI group and posttest questionnaire in both groups. The impact of EI among respondents was evaluated by their response to questionnaire and number of ADRs reported after intervention. Results: Total (n = 202) respondents were enrolled in the study. The number of resident doctors and faculty members in each group were (n = 101 [50%]). Overall, (n = 100 [49.5%]) were from the medical and (n = 102 [50.5%]) from surgical specialty. Post-EI period, there was statistically significant improvement in KAP domains. Conclusion: Our study serves as credible evidence that through EI; statistically significant improvement in KAP of resident doctors and faculty members in both medical and surgical specialties toward ADR reporting and existing pharmacovigilance system can be achieved.

A case of hypersensitivity to soluble and isophane insulins but not to insulin glargine.

Insulin is an important agent for the treatment of diabetes mellitus (DM). Allergic reactions to insulin therapy, although rare, have been evident since animal insulin became available for the treatment of DM in 1922. Hypersensitivity to insulin has considerably been reduced with the introduction of human insulin produced by recombinant deoxyribonucleic acid technology. Here, we present a case of Type 2 DM who demonstrated immediate (Type 1) hypersensitivity reaction on the sites of subcutaneous injection of soluble and isophane insulin but insulin glargine was tolerated well and provided good glycemic control.

A study of agreement between the Naranjo algorithm and WHO-UMC criteria for causality assessment of adverse drug reactions.

OBJECTIVES: Reliability and usefulness of various adverse drug reaction (ADR) causality assessment scales have not been fully explored. There is no universally accepted method for causality grading of ADRs. In the present study we assessed agreement between the two widely used causality assessment scales, that is, the World Health Organization-Uppsala Monitoring Center (WHO-UMC) criteria and the Naranjo algorithm. MATERIALS AND METHODS: The same observer assessed all ADRs (n = 913) collected between January 2010 and December 2012 using the WHO-UMC criteria and Naranjo algorithm at a tertiary care hospital in India. We found that the most frequently assigned causality category was "possible" with both the scales. RESULTS: A disagreement in the causality assessment was found in 45 (4.9%) cases reflecting "poor" agreement between the two scales (Kappa statistic with 95% confidence interval = 0.143 [0.018, 0.268]). The mean time taken to assess causality of the ADR using the WHO-UMC criteria was shorter than that by the Naranjo algorithm. CONCLUSION: This study showed that there is a poor agreement between the WHO-UMC criteria and Naranjo algorithm with the former being less time-consuming.

Ethics reporting practices in clinical research publications: A review of four Indian journals.

BACKGROUND: Manuscript authors of scientific journals are expected to report if their studies were conducted according to international and national ethical guidelines and inform readers regarding ethics approval and informed consent obtained from participants and/or their legally acceptable representative/s. In the present study we assessed the reporting practices of ethics approval and informed consent (assent in case of pediatric studies) in four Indian journals. MATERIALS AND METHODS: Original research articles published over a period of 4 years (2009-2012) in four major national clinical journals, viz. Journal of Association of Physicians of India (JAPI), Indian Journal of Surgery (IJS), Journal of Obstetrics and Gynecology of India (JOGI), and Indian Journal of Orthopedics (IJO) were reviewed with regard to documentation of ethics approval and written informed consent and assent in case of pediatric participants. RESULTS: We reviewed 673 research articles and found that, overall ethical approval was mentioned in 163 (24.2%) and informed consent or assent was mentioned in 179 (26.5%) articles in all four journals. Individually we found, in JAPI of the 174 manuscripts reviewed, 74 (42.5%) reported having obtained approval from the ethics committee and 68 (39.1%) reported taking written informed consent from participants. In IJS of 123 manuscripts, 18 (14.6%) reported ethics committee approval and 20 (16.2%) reported informed consent from participants. In JOGI of 152 manuscripts, 21 (13.8%) reported ethics committee approval while 49 (32.2%) reported informed consent from participants. In IJO, of 224 manuscripts, 50 (22.3%) reported ethics committee approval and 42 (18.7%) reported obtaining informed consent. CONCLUSION: Majority of the publications did not provide information regarding compliance to ethical guidelines in spite of the availability of various guidelines. Thus, there is a need for awareness and training on bioethics for authors, reviewers, and editors of biomedical journals.

Serum drug level-related sodium valproate-induced hair loss.

Sodium valproate is a well-established treatment in epilepsy and mood disorders. Its utility is compromised by its adverse effects such as tremor, weight gain, hair loss, and liver dysfunction. Hair loss may occur when drug is used in higher dose. Drug-induced hair loss is diffused and non-scarring, which is reversible upon withdrawal. But there are no case reports showing relation between serum levels of valproate and occurrence of hair loss. So we took interest in reporting this case report.

A prospective study of adverse drug reactions to artemisinin-based combination therapy in a tertiary care hospital in India.

OBJECTIVES: Antimalarial drugs are commonly prescribed for the treatment of malaria and suspected cases of malaria in India. The recent trend is to prescribe ACT and the incidence of adverse reactions to this therapy is notwell-documented in Indian population. Therefore, this study was designed to assess ADR pattern of antimalarial drugs particularly ACT in India. MATERIALS AND METHODS: Over a period of 1 year, 500 patients who were administered antimalarial drugs were enrolled in the study. The World Health Organization causality assessment scale was used for classifying the ADR. RESULTS: In this study out of 500 patients, 251 complained of ADRs. The sex-wise difference in reporting of ADRs was statistically not significant (P=0.0943). The most common ADRs reported were nausea, anorexia and vomiting. ADRs were most commonly reported when chloroquine was coprescribed. CONCLUSIONS: This study indicates that ACT was commonlyused in the treatment of malaria. Results of the analysis suggest that all the ADRs were of moderate intensity and no serious ADR was observed. This baseline information will be useful to implement the ACT in India.