WHO-UMC Causality Assessment Research Articles

Comparative study to evaluate efficacy and safety of topical alcaftadine 0.25% versus topical olopatadine 0.2% eye drops in patients with allergic conjunctivitis in a tertiary care teaching hospital, Haldwani

Background: Ocular component is the most prominent and disabling feature of allergy leading to symptoms like itching and watering of eyes causing significant irritation. Allergic conjunctivitis (AC) is one of the most common ocular conditions affecting adult and pediatric patients that requires treatment by ophthalmologists. AC and its debilitating symptoms like itching, watering of eyes and ropy discharge have interfered their day to day activities, difficulty in concentrating in work and has adversely affect the quality of life. Aim and objectives were to study and compare the efficacy and safety profile of topical alcaftadine versus topical o lopatadine eye drops in patient with AC. To compare efficacy of topical alcaftadine versus topical olopatadine eye drops, to observe adverse drug reaction of both eye drops. Methods: A prospective, open labelled comparative hospital based study was conducted in the department of ophthalmology in collaboration with department of pharmacology GMC Haldwani, Uttarakhand. Patients with AC (n=120) were randomised into two groups: Alcaftadine 0.25% eye drop and olopatadine 0.2% eye drop once daily. Patients were assessed on the first day 2nd week and 4th week. Reduction in total severity score and efficacy was measured in both treatment groups. Safety was assessed by observing adverse drug reaction using WHO UMC Causality assessment scale and modified Hartwig Siegel’s severity scale. Results: A trend in significant improvement in patients treated with alcaftadine eye drop in comparison to patients treated with olopatadine eye drop at both second week and fourth week follow up. No adverse effects were reported with either eye drops in both groups. Conclusions: Alcaftadine eye drop showed higher efficacy than olopatadine eye drop in relieving signs and symptoms of AC. Both treatment groups were found to be safe and effective.

Pattern, severity, and preventability of adverse drug reactions from a Northern Indian tertiary care facility: A retrospective analysis

Background Over the years, it has been observed that adverse drug reaction (ADR) is a major cause of mortality and morbidity and a major cause of concern for all healthcare professionals. ADR is a leading cause for hospitalisation and increases the financial burden of the patient. Thus, it is imperative that we need steps and strategies to decrease the burden of ADRs and effectively reduce the cost of therapy to treat ADR. Objective This study evaluated the pattern, severity, and preventability of ADRs in a tertiary care hospital. Methods A retrospective observational study of all the ADR reports due to medications submitted to the ADR monitoring centre in a Northern Indian tertiary care hospital from October 2017 to December 2019. Causality assessment of the ADRs was done using the WHO-UMC causality assessment scale, and the severity was assessed using the modified Hartwig scale. Furthermore, the preventability of the ADR was assessed using the Schumock and Thornton scale. Results A total of 252 ADRs were reported. A maximum number of the ADRs (33%) were due to antimicrobials followed by analgesics (16%) and antihypertensives (10%). Amongst the analgesics, a majority of ADRs were associated with Diclofenac (16 ADRs). Amlodipine was associated with maximum ADRs (10) amongst the antihypertensives. The ADRs of gastrointestinal systems (34.5%) were most common among all system organ class (SOCs) followed by skin and subcutaneous tissue disorders (32%). Majority of ADRs were probable and mild in severity. According to the Schumock and Thornton preventability scale 69% were not preventable while 12% were definitely preventable. Conclusions Antimicrobials were associated with majority of ADRs with gastrointestinal system being the most commonest organ involved. It was also observed that most of the ADRs were not preventable but some were definitely preventable. The awareness regarding preventability of ADRs needs to be emphasised and further studies to elaborate on the preventability of ADRs needs to be carried out.

A cross sectional study to analyse the ADR reported in a hospital during the past three years

Introduction: Cross sectional study is a type of observational study that analyzes data from apopulation, or a representative subset, at a specific point in time-that is, cross sectional data. The causality appraisal is assessment of the probability that the detected adverse event is produced by a specific medication. The most commonly used causality assessment scales are Naranjo Probability Scale and the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) causality scales. The study is to analyze the adverse drug reaction reported in a hospital for the past three years. Aim: A cross sectional study to analyze the ADR reported in a hospital during the past three years. Methodology: A cross sectional observational study was conducted at Nirmala medical centre, Muvattupuzha. ADR reported in the past three years in this hospital were analyzed. Drug leading to ADR, department .gender, observed reaction, severity, Naranjo probability scale and WHO UMC causality assessment were done. Classification of drugs according to their drug class, classification of ADR according to the system, based on severity, sex, Naranjo score, WHO UMC criteria were done. The datas were analysed and represented into graphs. Result: A total of 342 ADR reports were analyzed in this study. The key findings of this study include: Skin-related ADRs were the most frequently reported, affecting 27.83% of cases. The majority of reported ADRs were of moderate severity (56.7%).Naranjo probability scale and WHO-UMC causality assessment indicated that most cases were in the probable category, with 63% and 76%, respectively. The general medicine department had the highest number of reported ADRs. Males accounted for the majority of reported ADRs (57.18%).Cardiovascular agents and antibiotics were the drug classes most commonly associated with reported ADRs, at 25.6% and 22.28%, respectively. Among cardiovascular agents, diuretics were found to be the primary culprits, causing 38.66% of reported ADRs. Conclusion: This study highlights the importance of monitoring, assessing, and documenting ADRs in healthcare facilities, as it provides valuable insights into the prevalence, severity, and causality of adverse drug reactions. This information can contribute to improving patient safety and the rational use of medications in clinical practice.

Pantoprazole induced black hairy tongue: a case report

Black hairy tongue (BHT) is characterized by abnormally hypertrophied and elongated filiform papillae, appearing as blackish discoloration on the dorsal surface of the tongue. BHT has been reported as an adverse drug reaction to different categories of drugs. However, pantoprazole induced BHT has been rarely reported. We present the case of a 42-year-old female, admitted in the surgery ward with postoperative wound infection, for which she was prescribed oral clarithromycin and pantoprazole. On the third day of starting medications, she complained of blackish discoloration on the dorsal surface of the tongue with an alteration of taste sensation, which was clinically and microscopically diagnosed as BHT. Suspecting BHT as an adverse drug reaction to pantoprazole, it was stopped, while clarithromycin was continued for the full course. She was also advised to scrape her tongue thrice daily, drink adequate fluids and maintain good oral hygiene. On the third day after stopping pantoprazole, black discoloration and alteration of taste sensation resolved completely. WHO-UMC causality assessment scale showed a ‘probable’ association of the adverse drug reaction with pantoprazole. Physicians should be aware of the possibility of BHT with the use of pantoprazole and that it completely resolves on stoppage of the drug, mechanical debridement and good oral hygiene.

Assessing the impact of methotrexate, hydroxychloroquine, and their combination in rheumatoid arthritis: efficacy, safety, and cost analysis with vitamin D3 and BMI

Background: A chronic, symmetrical & inflammatory disease, which affects small joints and later progresses to involve large joints. To promote remission and control further joint destruction, disease modifying ant rheumatic drugs are used. The role of low Vitamin D3 and High BMI have been found in pathogenesis of RA. Methodology: The study was designed by Department of pharmacology and patients were enrolled from department of medicine. This was an open label; prospective study. After obtaining, informed written consent, the subjects were randomized in three groups, Group 1-Methotrexate 7.5-15mg once a week, Group 2 - Hydroxychloroquine 200mg BD and Group 3-Methotrexate 7.5mg once a week Plus HCQ 200mg OD. The Vitamin D3 levels and Body mass index was assessed at first visit. The quality of life was assessed using DAS-28/CRP, RAPID-3 Score. Average cost-effective ratio was also calculated. The adverse effects were also assessed using WHO-UMC causality assessment. The statistical analysis of the data Graph pad insta version 3.1 was used, p-value <0.05 was considered statistically significant. Results: The mean changes in DAS28/CRP and RAPID-3 between baseline & 16 weeks was highly significant (p<0.0001) in all groups. Vitamin D3 levels at baseline was 19.14±0.42, 19.86±0.67 and 19.52±0.98 in all groups respectively. Conclusion: The vitamin D3 levels were in the lower limit and BMI was raised in almost all the patients at first visit. The efficacy of combination therapy is found to be better when given at initial stages of RA patients

Assessing the impact of methotrexate, hydroxychloroquine, and their combination in rheumatoid arthritis: efficacy, safety, and cost analysis with vitamin D3 and BMI

Background: A chronic, symmetrical & inflammatory disease, which affects small joints and later progresses to involve large joints. To promote remission and control further joint destruction, disease modifying ant rheumatic drugs are used. The role of low Vitamin D3 and High BMI have been found in pathogenesis of RA. Methodology: The study was designed by Department of pharmacology and patients were enrolled from department of medicine. This was an open label; prospective study. After obtaining, informed written consent, the subjects were randomized in three groups, Group 1-Methotrexate 7.5-15mg once a week, Group 2 - Hydroxychloroquine 200mg BD and Group 3-Methotrexate 7.5mg once a week Plus HCQ 200mg OD. The Vitamin D3 levels and Body mass index was assessed at first visit. The quality of life was assessed using DAS-28/CRP, RAPID-3 Score. Average cost-effective ratio was also calculated. The adverse effects were also assessed using WHO-UMC causality assessment. The statistical analysis of the data Graph pad insta version 3.1 was used, p-value <0.05 was considered statistically significant. Results: The mean changes in DAS28/CRP and RAPID-3 between baseline & 16 weeks was highly significant (p<0.0001) in all groups. Vitamin D3 levels at baseline was 19.14±0.42, 19.86±0.67 and 19.52±0.98 in all groups respectively. Conclusion: The vitamin D3 levels were in the lower limit and BMI was raised in almost all the patients at first visit. The efficacy of combination therapy is found to be better when given at initial stages of RA patients

Evaluation of Metabolic Parameters on Use of Newer Antiepileptics Versus Conventional Antiepileptics in Patients of Generalised Tonic-Clonic Seizure: An Observational Study.

Background and objective Epilepsy is the commonest serious neurological condition and around 50 million people live with epilepsy (PWE). Primary and secondary generalised tonic-clonic seizures (GTCS) together constitute up to 50% of adult and adolescent epilepsy. GTCS respond well to broad-spectrum AEDs like valproate, phenytoin, levetiracetam, lamotrigine, and topiramate. Carbamazepine and oxcarbazepine are considered alternatives. Metabolic derangements with the conventional AEDs (phenytoin causes loss of bone mass in women, phenytoin and carbamazepine produce increases in serum lipid and C-reactive protein, weight gain with valproate) are well documented. But, there is limited data regarding the effect of the newer AEDs on metabolic parameters. Thus, this study was undertaken to assess the effects of the newer AEDs on the metabolic profile of patients with epilepsy. Material and methods A prospective observational study was conducted in the Department of Pharmacology, in collaboration with the Department of Neurology at S.C.B. Medical College and Hospital, Cuttack. 100 diagnosed patients with GTCS receiving monotherapy of either conventional or newer anti-epileptics were included in the study. Their metabolic parameters like total cholesterol, serum sodium, serum TSH and fasting blood glucose were collected at baseline, three months, and six months. ADRs were collected during the entire study period and causality assessment was done using WHO-UMC Causality Assessment Scale. All the data were analysed using SPSS 20.0 after applying appropriate statistical tests. Results There was a significant increase in total cholesterol in all four groups (p=0.002) but a pathological increasein the phenytoin and oxcarbazepine groups. There was a significant rise in the serum TSH levels in all groups except levetiracetam, but a pathological increase was seen with phenytoin and valproate, i.e., the conventional ones. Statistically significant hyponatremia was seen with valproate and oxcarbazepine. A rise in the FBS was seen with both phenytoin and valproate (p=0.002) but a pathological rise was seen with phenytoin. Out of the total reported ADRs, 53.5% were seen with conventional AEDs, and the rest 46.5% were seen with newer ones. Conclusion The advent of newer anti-epileptic drugs has unfolded wider horizons to the treatment of epilepsy. Each of these drugs has a unique mechanism of action, making it less prone to resistance. Metabolic derangements are a key determinant in the compliance of these drugs as they can predispose to other co-morbidities. Periodic monitoring of the various metabolic parameters is useful and together with patient counselling can improve the effectiveness of the anti-epileptic drugs.

Taxanes induced hypersensitivity reactions in cancer chemotherapy patients reported at adverse drug reaction monitoring centre at a tertiary care hospital

Background: Cancer chemotherapy involves highly complex regimens using antineoplastic agents like taxanes (paclitaxel, docetaxel) etc. Taxanes cause hypersensitivity reactions (HSRs) like redness, rashes, dyspnoea, severe anaphylaxis and death. In this study, adverse drug reactions (ADRs) associated with taxanes are described & analysed on their severity and preventability. The present study aims to analyse and determine the prevalence of ADRs, especially HSRs in patients treated with taxanes.Methods: After getting IEC approval, the present study is done retrospectively by assessing the HSRs in suspected ADR reporting forms from December 2019 to February 2022 in ADR monitoring centre (AMC) in the Department of Pharmacology at Kurnool Medical College, Kurnool. Descriptive statistics used to analyse patient demography, frequency, various carcinomas under treatment & organ involved, causality assessment using WHO-UMC Scale and Naranjo's Algorithm, severity assessment using modified Hartwig & Siegel’s scale and preventability by modified Schumock & Thornton scale.Results: A total of 258 ADRs were recorded, of which 30 cases reported HSRs with taxanes-paclitaxel (22) and docetaxel (8). The most commonly occurred HSR is shortness of breath. Naranjo’s algorithm showed 52.5% possible (score 1-4) HSRs. WHO-UMC causality assessment scale showed 56.4% as probable HSRs. Modified Hartwig & Siegel severity scale showed 46.6% moderate (level 3). Modified Schumock and Thornton scale showed 76.9% as not preventable.Conclusions: Chemotherapy-related ADRs among cancer patients urges the oncologists to be actively involved in ADR reporting, in the need of the hour in order to mitigate, avoid their occurrence and reducing morbidity and mortality, when practiced with diligence.

A Retrospective study of contrast media related adverse drug reactions at tertiary hospital in South India

: Adverse drug reaction not only occurs with curative, preventive and palliative drugs but also with diagnostic tools like radio contrast agents which are used for enhancement of images. Timely and incessant reporting of adverse drug reaction with various agents is necessary to reduce the incidence. The study aims to find out the trend of contrast media related adverse drug reactions from 2016 to 2021. A retrospective observational study was conducted on adverse drug reactions reported to the adverse drug reaction monitoring centre at tertiary care hospital in South India. All the adverse drug reactions related to various contrast agents used in computed tomography and magnetic resonance imaging were recorded. Patients’ demographic details, individual contrast agent, clinical manifestations of reactions, severity, causality were mentioned in descriptive statistics. : A total of 218 (16%) adverse drug reaction were reported due to various contrast media including non-ionic iodinated and gadolinium-based agents. The incidence of adverse drug reactions with radio contrast agents varies between 0.23% - 0.35%. 89% of symptoms were itching and rashes. Using the WHO-UMC (Uppsala monitoring centre) causality assessment scale, 87% of adverse drug reactions were categorized as ‘probable’. : Unavoidable and untoward reactions can happen in any patient with any contrast agent. With the introduction of newer agents for last six years reactions continue to occur in same proportion. There is no culprit agent, but being ‘vigilante’ on reactions and timely reporting is necessary.

Comparative Experimental Evaluation of L-carnitine and Cholecalciferol on Amikacin Induced Nephrotoxicity and Clinical Evaluation of Amikacin Induced Adverse Drug Reactions

Background: Reduction of health cost burden with existing low-cost drug and thereby improving patient compliance is utmost necessary. Keeping in mind the above, we started with low cost, broad spectrum, WHO enlisted essential drug amikacin. We tried to revaluate it with another two low-cost drugs, L-carnitine, and Cholecalciferol. Objectives: Measurement of amikacin induced nephrotoxicity by means of abnormal renal biochemical parameters on albino rats and comparison of improvement after administration of L-carnitine & Cholecalciferol along with renal histopathology examination (HPE) of amikacin treated rats and causality assessment of amikacin induced adverse drug reactions (ADR) in hospitalized patient. Materials and Methods: Healthy albino male rats (N=40) were taken from Institutional animal house of Burdwan medical College and Hospital (BMCH) and were randomly divided into 4 groups. CPCSEA acclimatization guideline followed. IEAC and CREC clearances taken. Renal biochemical parameters from blood samples were analysed. Sterile water for injection was given to all group. Group I is control (only vehicle), Amikacin added to Group II, III and IV. L carnitine & Cholecalciferol was added to Group III & Group IV respectively. Post test measurement of renal biochemical parameters and HPE were done. Clinical observation of amikacin treated hospitalised patients and collection of their ADR in BMCH were done to find out correlations with animal experiment. Results: Statistical analyses were done using Graph Pad Prism version.4 software. Minimisation of amikacin induced nephropathy were seen, more in Group IV than Group III. HPE found the same conclusion. WHO UMC causality assessment revealed, 94.35% ADR were “probable/likely” whereas 5.65% were “possible”. The Naranjo’s adverse reaction probability scale revealed almost the same. Conclusion: Interventional animal experiment, biochemical parameters, histopathology along with open label, non-interventional, prospective observational study clearly indicates cholecalciferol is significantly better than L carnitine to minimise the effects of amikacin induced nephropathy.

Histopathological and clinical correlation of cutaneous adverse drug reaction

<p><strong>Background:</strong> The aim was to study the histopathological features of cutaneous adverse drug reactions (ADRs) and its correlation to clinical presentation.</p><p><strong>Methods:</strong> We carried our study on 80 patients of drug reactions presented in OPD over a period of 24 months. We noted offending drug, time gap between drug intake and appearance of lesion clinically and performed biopsy to study histopathological patterns and their utility as an aid to diagnosis. WHO-UMC causality assessment method was used in few cases with due diligence. AGEP (acute generalized exanthematous pustulosis) validation score of the EuroSCAR study group was used and SCORTEN for prognosis of SJS/TEN (Stevens-Johnson syndrome/toxic epidermal necrolysis). Histopathological correlation and clinical correlation were statistically analysed.</p><p><strong>Results:</strong> The most common histopathological finding was vacuolar interface dermatitis and presence of eosinophils. The most common drug responsible was antimicrobials. Histopathological findings were most consistent in cases of FDE and AGEP and differentiating viral exanthems from maculopapular rash was challenging. Erythroderma showed varying patterns of histopathology</p><p><strong>Conclusions:</strong> Identification of histopathological patterns and clinical correlation is important for distinguishing between cutaneous ADR and the other inflammatory dermatoses. Drug reactions pose clinical challenge thus clinicopathological correlation can help in reaching diagnosis.</p>

Thalidomide and steroid in the management of erythema nodosum leprosum.

OBJECTIVE:The objective of the study was to assess the efficacy and safety profiles of combined treatment of prednisolone with thalidomide (Gr-A) and prednisolone with clofazimine (Gr. B) in patients with erythema nodosum leprosum (ENL) or type 2 lepra reactions.MATERIALS AND METHODS:Efficacy of both regimens was assessed on the basis of clinical recovery of recurrent ENL measured by reaction severity score (RSS), Visual Analog Scale (VAS), and recurrence of type 2 lepra reaction. The causality assessment of adverse drug reactions was done using the WHO UMC causality assessment scale.RESULTS:The average age of patients with recurrent ENL was 42.8 years (male) and 51.8yrs (female) and had mean duration of leprosy and recurrent ENL 2.4 years and 2.09 years, respectively. 80% of nonrecurrence was observed in Gr-A versus 66% in Gr-B. Significant (P < 0.05) lower RSS and VAS was found in both the treatment groups as compared to pretreatment value. The reduction in RSS and VAS was statistically significant (P < 0.05) in Gr-A compared to Gr-B treatment.CONCLUSION:Thalidomide combination with steroid was found to be more efficacious than clofazimine combination with steroid in the treatment of ENL both the treatment regimens showed few tolerable side effects. Improved strategies for the treatment and management of these reactions need to be developed.

Evaluation of glycemic status among hypercholesterolemic patients on atorvastatin in a tertiary care hospital - A retrospective study.

INTRODUCTION:Statins are effective in reducing low-density lipoprotein cholesterol and are favorable in primary and secondary prevention of cardiovascular disease. Recent large trials have linked the use of statins and increased incidence of new-onset diabetes mellitus, the possibility of worsening of glucose level in individuals with diabetes following statin therapy, and this possibility is increased with the use of atorvastatin. This study was undertaken to analyze the possibility of the diabetogenic potential of atorvastatin among hypercholesterolemic patients.MATERIALS AND METHODS:This retrospective cohort study was conducted in the cardiology department from July 2019 to December 2019. Patients on atorvastatin for more than 6 months with normoglycemia on commencement of therapy were included. The occurrence of prediabetes or new-onset diabetes mellitus after atorvastatin therapy is the outcome of the study. Adverse drug effects to atorvastatin were also recorded and WHO-UMC causality assessment was performed. Descriptive statistics were performed for baseline and demographic characteristics.RESULTS:Sixty study participants were included in the study. Eighteen (30%) study participants developed prediabetes with an HbA1c value of 5.97 ± 0.22 and 17 (28%) of participants developed new-onset diabetes mellitus with an HbA1c value of 7.24 ± 0.50. Atorvastatin at dose of 40 mg was found to be the most frequently prescribed dose.CONCLUSION:Atorvastatin has a dose-dependent risk of developing new-onset diabetes mellitus. Hence, the following statin therapy glycemic status should be periodically monitored especially in patients with a large dose of atorvastatin and also in patients with higher risk factors for diabetes.

POSA21 An In-Hospital Study to Trace the Risk Factors Associated with Adverse Drug Reactions during the Second Wave of COVID-19 in a Secondary Care Hospital in India

To characterize the adverse drug reactions (ADRs) and the risk factors associated with COVID -19 treatment in a secondary care hospital in South India. A prospective observational study was carried out on 327 patients admitted between April 1 and May 15, 2021, using an in-person surveillance system. The demographic characters of all the patients including the time of admission, comorbid diseases, length of stay, history of drug allergies, and the number of medications used during hospitalization were collected. After identification of an adverse drug event, the causality, suspicious drugs, and prognosis of ADRs were also recorded. Descriptive statistics and multivariate logistic regressions were carried out to analyze the risk factors of ADRs. Out of the 327 patients, 194 (59.3%) were men and the mean age was 45.7± 16.6 years. 122 ADRs were reported among 87 patients with an incidence rate of 26.6%. Most of the reactions were associated with dexamethasone (31.9%), remdesivir (18%), and favipiravir (14.7%) with dexamethasone-induced hyperglycemia being most prominent. The majority of the suspected ADR cases were categorized as probable (61.8%) according to the WHO-UMC causality assessment. When compared with the No ADRs group, the length of stay (p=0.004), history of drug allergies (p<0.001), number of drugs used in treatment (p<0.001) were significantly higher in the ADRs group. Multivariable analysis revealed that length of stay (OR: 2.03; 95% CI 1.02–3.98; P = 0.04), comorbidities (OR: 2.08; 95% CI 1.05–4.18; P = 0.04), number of drugs used for treatment (OR: 3.17; 95% CI 1.60–6.27; P = 0.001) and were independent risk factor for ADRs in the patients. Active surveillance measures are important in case of all drugs used for COVID treatment to keep the living guidelines the most live one.

A STUDY ON ADVERSE DRUG REACTION PATTERNS OF INJECTABLE ANTIBIOTICS REPORTED IN THE PHARMACOVIGILANCE CENTRE OF A TERTIARY CARE TEACHING INSTITUTE, MANIPUR

Background:Antibioticsare one of the most commonly used drugs in hospitalised patients and are sometimes associated with significant safety concerns. However, there is still insufficient data about the incidence of adverse drug reactions(ADR) especially in case of injectable antibiotics. This study was done to assess the severity and pattern of different types of adverse drug reaction that occurs with commonly used injectable antibiotics. Method: A retrospective cross-sectional study was done at Pharmacovigilance centre RIMS utilizing data from January 2018 till December 2019. Result: A total of 146patients who presented with antibiotic associated ADR reported during the study period were included in this study. Incidence was higher in males (90) as compared to females (56). The most common injectableantibiotic responsible for ADR was found to be the cephalosporin group (42.6%). A total of 178 different ADRs were observed among 146 patients, out of which the dermatological system (27.4%) was the most commonly affected system. On evaluation of WHO-UMC causality assessment of ADRs, majority were found to be possible (64.4%). Conclusion:Injectable antibioticsare one of the most importantdrugs used for treatment of various clinical conditions and the sheer magnitude of their usage among hospitalised patientsrequires special monitoring especially with respect to the adverse reactions they can cause.A more active pharmacovigilance is needed for better understanding of the types of injectable antibiotics associated ADRs. Active monitoring can also help promoterational use of these important life saving drugs.

Adverse Drug Reaction Monitoring of Antidepressant Drugs in a Mental Health Institute in Odisha

Introduction: Antidepressants are used primarily in the management of depressive and anxiety disorders. The occurrence of adverse drug reactions (ADRs) to antidepressants is a major challenge as it influences patient compliance. Aim: The aim of this study was to find out the ADR profile of antidepressant drugs in a mental health institute in Odisha. Materials and Methods: This is a cross sectional observational study conducted in Department of Pharmacology in collaboration with Mental Health Institute (Centre of Excellence) S.C.B Medical College and Hospital, Cuttack from September 2017 to September 2019. Patients who received at least one antidepressant drug were included in the study irrespective of age and sex. Data were collected by interviewing the patients or attendants and on detection of ADR, it was recorded on suspected ADR reporting form designed by PvPI. Causality, severity and preventability of ADRs were assessed by, WHO-UMC causality assessment, modified Hartwig-Siegel Scale and modified Schumock-Thornton criteria respectively. Results: Out of 180 patients taking antidepressants, ADRs were reported in 24% of patients, with either possible or probable causality. None were labelled as certain. ADRs were observed in 50% of patients who received TCAs and among 34.5% who received polytherapy. Insomnia (27%), fatigue (17%) and agitation (13%) were most common ADRs. Most of the ADRs were of mild severity (91%) and not preventable (84%). Conclusion: Insomnia, fatigue and agitation were among most common ADRs. There was increased chance of ADRs with polytherapy and use of TCAs. Most ADRs were mild and not preventable.

Monitoring Adverse Effects of Antipsychotics and Antidepressants: A Population Based Study

Abstract: Aim: To monitor the nature and incidences adverse effects of both antipsychotics and antidepressants medicines in the psychiatry outpatient department. Objectives: Reporting the incidences of adverse effects and to establish the frequency of a specific class of drug. Identifying the system affected and the assessment of the management of the adverse effects by the physician. For the study, we have adopted Global Assessment Scale (GAS), Simpson-Angus Extra pyramidal Side Effects Scale (SAS) and The Antidepressant Side-Effect Checklist (ASEC). Materials and Methods: A prospective cohort study carried out in the psychiatry out-patient department. All the patients attending psychiatry outpatient department enrolled based on the pre-specified inclusion criteria and monitored for adverse effects. Causality also assessed by WHO-UMC causality assessment system and Naranjo Causality Assessment. Results: The incidence rate of adverse effects (46.07%) and 560 adverse effects documented. Weight gain (n=29, 9.2%) followed by drowsiness (n=27, 4.82%) are most commonly reported adverse effects. Atypical antipsychotics (n=279, 49.82%) were the most common class of psychotropic drugs implicated in adverse effects. Escitalopram (n=93, 37.80%) followed by olanzapine (n=53, 21.54%) associated with a maximum number of adverse effects. Central nervous system (n=225, 40.17%) was the most affected organ system followed by gastrointestinal system (n=130, 23.21%). Conclusion: Study revealed moderate incidences of adverse effects in patients attending the psychiatry outpatient department. Majority of the adverse effects reported during the study were mild in nature and not preventable. The role of a clinical pharmacist clearly elucidated regular intensive monitoring of adverse effects may improve the quality of patients’ care, reduction in the treatment cost and augmentation of the medication adherence among patients. Key words: Adverse effects, Pharmacovigilance, Antipsychotics, Antidepressants, Extra pyramidal side effects.

A prospective observational study of ophthalmic adverse drug rections in a tertiary care hospital

Background: According to an epidemiological study, 1.7–25.1% of eye disease was drug induced, but the evidence of adverse drug reactions (ADRs) in ophthalmology is found to be scarce, as it is difficult in correlation between symptoms and ocular signs, and their causality assessment. Hence, the present study of ADR in ophthalmology is taken up. Aim and Objectives: The aim of the study was to assess the pattern of reported ophthalmic ADR due to ophthalmic or systemic drugs and systemic ADRs due to ophthalmic drugs and to assess the causality, severity, and preventability factors of reported ADRs. Materials and Methods: A prospective observational study enrolling 100 subjects with ocular ADRs due to ocular or systemic drugs, and systemic ADRs due to ocular drugs visiting KIMS Hospital and Research Centre, Bengaluru. Following Institutional Ethics Committee approval and clearance, and written informed consent from study subjects, 100 consecutive subjects fulfilling inclusion and exclusion criteria will be included for the study. The causality of ADRs is assessed by WHO-UMC and Naranjo’s causality assessment scale. The severity of ADR assessed using Modified Hartwig scale. The preventability of ADR assessed by Modified Schumock and Thornton scale follow-up will be done for severe ADRs. Results: The clinical spectrum of ADRs ranged from mild redness of the eyes, itching, lacrimation, blurred vision, and purulent discharge from the eyes and to loss of vision. The most common causative drugs were antimicrobials, anti-inflammatory agents, antiepileptics, and mydriatics. Majority of ADRs were probable in WHO-UMC causality assessment, mild in severity, and definitely preventable. No fatal cases were reported. Conclusion: The clinical pattern of reported ocular ADRs due to topical and systemic drugs from the ophthalmology department and in wards ranged from mild severity to moderately severe reactions requiring patient hospitalization.

Severe cutaneous adverse reactions to drugs: a case series study

Objective: to describe five cases of severe cutaneous adverse reactions to drugs (SCARD) that led to hospitalization and were investigated and diagnosed by the dermatology service of a university hospital. Methods: this is a descriptive observational study of the case series type in which were included patients aged 18 years old or older from both sexes, hospitalized between January 2015 and July 2019, in a university hospital in Rio de Janeiro, Brazil and whose reason for hospitalization was SCARD diagnosed by the dermatology service. For SCARD causality assessments, two internationally adopted criteria were used: the Naranjo algorithm and the WHO-UMC causality assessment system. Results: five cases of RCAG have been reported. Amongst these, three cases of erythroderma, one of Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and one of drug reaction with eosinophilia and systemic symptoms (DRESS). The cases of erythroderma have presented as suspected drugs substances such as hydrochlorothiazide, furosemide, captopril and carbamazepine, which is consistent with the literature reports. In the reported case of SJS/TEN, both the suspected drug, allopurinol, and the presence of an anti-HIV positive laboratory test are also referred to in the literature. The case of DRESS has shown allopurinol as a suspected drug, which is already related to this well-described skin reaction. The causalities were assessed as possible for the first two cases and probable for the following three. The results of the study supported the proposal for a model of pharmacovigilance of SCARD in a hospital environment, consisting of spontaneous reporting, periodic checking of medical records and for requests of opinion from the dermatology service registered in the hospital's computerized system. Conclusion: this study contributes to add knowledge and better understanding about SCARD, in regards to the nature of the type of reaction, identification of patients at risk, early detection of these and the responsible drugs. Furthermore, it proposes a model for monitoring SCARD to be implemented in the hospital, which combines passive and active pharmacovigilance strategies and encourage notification by health professionals.

A Study of Agreement between WHO-UMC Causality Assessment System and the Naranjo Algorithm for Causality Assessment of Adverse Drug Reactions Observed in Medical ICU of a Tertiary Care Teaching Hospital

Introduction Adverse Drug Reaction (ADR) can be defined as a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or modification of physiological function.[1] There are wide ranges of factors which c