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.

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.

Background: The present study was undertaken to evaluate the incidence and pattern of adverse drug reaction (ADRs), causality, severity and preventability of ADRs.Methods: Data was collected and analyzed with the information such as patients’ demographic details, associated co-morbid conditions and detailed drug related information gathered from ADR reporting forms. World Health Organization (WHO) scale was used for assessing causality, modified Hartwig scale was used for assessing severity and modified Schumock and Thorntons scale were used for assessing preventability of ADRs. Data was analyzed using descriptive statistics.Results: Total 154 ADRs were reported in a period of one year (August 2016- July 2017). Out of 154 ADRs analyzed, 120 (77.9%) were in adults, 33 (21.4%) pediatric and 01 (0.7%) in geriatric patients. The most common ADR recorded was cutaneous reactions (43.5%) and the most common causative class of drugs for the same was found to be antimicrobials (46.7%) followed by non-steroidal anti-inflammatory drugs (15.6%). Causality assessment scale indicated 68.8% ADRs possible and 24% ADRs as probable. Severity assessment revealed that 45.5 % were mild, 50.6% moderate and 3.9% ADRs severe. Preventability assessment showed 84.4% of the cases were probably non-preventable.Conclusions: In this study it was found that, most of the ADRs were of possible category with mild to moderate severity and majority being non-preventable. Antimicrobial drugs being the most common offending drug class causing ADRs. Strategies targeting appropriate and cautious use of this class of drugs may benefit in reducing the number of ADRs and therefore the cost involved in the treatment.

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.

Background: Coronary artery disease (CAD) is a major cause responsible for mortality more in younger age group than in elderly. Studies have reported underuse of four evidence based medicines namely aspirin, β-blockers, angiotensin-converting enzyme inhibitors (ACE-I) or angiotensin receptor blockers (ARB), and statins in patients with CAD, particularly in developing countries. Therefore, this study was planned to analyse the prescriptions of patients with CAD to determine the appropriateness of the prescriptions.Methods: After obtaining the Institutional ethics committee permission, a cross sectional observational study was conducted at a tertiary care hospital. Total 150 patients were enrolled from the outpatient department, wards and intensive care unit of medicine department. Total 150 patients’ prescriptions presenting with varied category of CAD were screened and analysed.Results: The most common categories of CAD encountered was ST segment elevated myocardial infarction (N=50, 33%) followed by chronic stable angina (N=29, 20%). Among the drugs prescribed, antiplatelet drugs were prescribed to 135 (90%), hypolipidemics to 134 (89%), nitrates to 114 (76%), beta blockers to 97 (65%), ACE inhibitors to 94 (64%), anticoagulants to 60 (40%) and miscellaneous drugs to 52 (35%), patients. Of 68 (45%) patients with type 2 diabetes mellitus, 15 (22%) were prescribed only metoprolol and others were given ACE-I or ARBs.Conclusions: Among four evidence based drugs, use of 3 drugs, antiplatelets, beta blockers and hypolipidemics was apparent in 90% of prescriptions. Use of ACE inhibitors and ARBs was observed in type 2 diabetic patients with CAD, reflecting rational prescribing behavior of clinicians.