Thornton Scale Research Articles

Prevalence of Adverse Drug Reactions in Diabetic patients receiving Antidiabetic Medications at Tertiary Care Hospital

Background: Diabetes mellitus is a chronic metabolic condition defined by elevated blood glucose levels caused by abnormalities in insulin secretion, insulin action, or both. Anti-diabetic drug pharmacovigilance can be extremely useful in identifying and resolving the adverse drug reactions (ADRs) and safeguarding patients from needless injury. Objective: The objective of the study was to determine the prevalence of various adverse events caused by the use of anti-diabetic medications in patients treated at tertiary care hospital. Method: It was a randomized controlled study where the participants were randomized into two groups i.e., interventional or study group and control group. All suspected ADRs were collected, analysed and confirmed by the physician-in-charge and were assessed for causality using WHO-UMC Causality Categories, Naranjo’s causality assessment scale, preventability using Modified-Schumock and Thornton scale, severity using Modified Hartwig and Siegel scale by the Causality Assessment Committee (CAC). Results: The study included a total of 300 subjects among which 218 were male (72.67%) and 82 were female (27.33%). A total of 300 patients, 104 ADRs were identified, in which 46.15% were observed in the control group and 53.85% in the interventional group. Females were more prevalent to the ADRs. The majority of ADRs were seen in age group of >70 in which 15.38% were observed in the control group and 18.27% in the interventional group. The Highest observed ADR of 20 (19.23%) was Hypoglycemia in which 9(8.65) were observed in the control group and 11(10.57) in the interventional group followed by weight gain i.e, 10 (9.61%) in which 5(4.80%) were observed in the control group and 5(4.80%) in the interventional group. Conclusion: ADR relating to antidiabetic therapy utilizing oral antidiabetics and insulin was found to be prevalent. The doctors and clinical pharmacists are therefore needed to identify and report the appropriate signals generated to the nearest ADR monitoring centre or Pharmacovigilance Programme of India for the benefit of the patients.

Adverse Drug Reactions Related with Antibiotic Medicines in Malawi: A Retrospective Analysis of Prevalence and Associated Factors.

We aimed to assess the occurrence and characteristics of antibiotic-associated adverse drug reactions (ADRs) in Malawi. We retrospectively reviewed 304 patient records from medical wards in three hospitals in Southern Malawi. A global trigger tool was applied for the detection of suspected ADRs, and we used the Naranjo scale, the World Health Organization classification and the Schumock and Thornton scale for causality, seriousness and preventability assessment respectively. ADRs were also further characterized according to anatomical systems. Statistical analysis was done in STATA 14.1. The Chi-square test was used to determine the association between categorical variables and logistic regression analysis was used to measure the strength of the association between various independent variables and the occurrence of ADRs. Suspected ADRs were detected in 24% (73/304) of patients, of which 1.4% were definite, 15.1% were probable and 83.6% were possible ADRs. Most of the sADRs were gastrointestinal events (42.5%), followed by: musculoskeletal (26.3%); cardiovascular (16.3%); central nervous system (13.8%; and urinary events (1.3%). About 27% of the sADRs were serious events such as convulsions. The geriatric age group (≥65 years) was more likely to experience sADRs as compared to the younger age group, with an adjusted odds ratio (aOR) of 4.53, 95% CI (2.21-9.28), P<0.001. Patients taking more than one antibiotic medicine had a higher risk of developing sADRs as compared to patients who were administered one type of antibiotic medicine, aOR 2.14, 95% CI (1.18-3.90), p < 0.012. A long hospital stay of >3days was associated with a higher risk of sADRs with aOR of 5.11, 95% CI (2.47-10.55), p < 0.001 than those who stayed ≤ 3 days in the hospital. We found a higher prevalence of serious sADRs associated with antibiotic medicines than reported elsewhere. This may, among others, contribute to high patient mortality, poor treatment adherence, antibiotic resistance and increased cost of care.

Pharmacovigilance Study of Anticancer Drugs in a Tertiary Care Teaching Hospital in North India: A Retrospective Study.

Anticancer agents are responsible for a majority of adverse drug reactions (ADRs) in cancer patients. ADR reporting with anticancer drugs is very rare in India due to the lack of awareness and knowledge about the Pharmacovigilance Programme of India. Hence, this study was done to assess the pattern of ADRs with anticancer agents in cancer patients and to increase awareness about ADR monitoring among healthcare professionals. This is an observational, retrospectiveand non-interventional study conducted in an ADR monitoring centre (AMC) in Govt. Guru Gobind Singh Medical College and Hospital, Faridkot, Punjab, North India. Voluntarily reported ADR forms with anticancer drugs as suspected drugs over a period of seven years from January 2016 to December 2022 were analyzed. Various parameters were analyzed, which include demographic details of the patients, type of ADR, department reporting ADR and suspected drug. Causality assessment, severity assessment and preventability assessment were done according to the World Health Organization Uppsala Monitoring Centre (WHO-UMC) scale, modified Hartwig and Siegel scale and modified Schumock and Thornton scale, respectively. The maximum numbers of ADRs were reported in the age group of 41-60 years (68.29%) and in females (59.75%). The maximum number of ADRs was reported with the use of taxanes (docetaxel and paclitaxel) (24.39%), targeted drugs (geftinib, imatinib, bortezomib, bevacizumab, rituximab and pazopanib) (24.39%) and platinum co-ordination complexes (cisplatin, oxaliplatin and carboplatin) (17.07%). Majority of the ADRs reported were shivering and ADRs on the skin. Majority of the ADRs were probable (64.70%), mild in nature (85.29%), definitely preventable (45.58%) and probably preventable (45.58%). ADR monitoring is needed to increase the outcome of anticancer drug treatment in cancer patients. The quality of treatment in cancer patients can be improved through the timely management of these ADRs. It is a need of the present era to inform healthcare professionals about the Pharmacovigilance Programme to increase the reporting of ADRs due to anticancer drugs.

Epidemiological investigation of emergency infusion adverse drug reactions in Nanjing, China: a prospective cross-sectional study

ABSTRACT Objective Little is known about the morbidity and mortality of infusion Adverse drug reactions (ADRs) in the emergency department. We sought to evaluate the epidemiology of emergency infusion ADRs. Materials and Methods This was a prospective study of infusion ADRs in the emergency infusion unit (EIU) of a tertiary hospital from 1 January 20201 January 2020, to 31 December 2021w31 December 2021. Emergency infusion ADRs were identified as intravenous drug-related ADRs that the causality was determined using the Naranjo algorithm. The incidence, severity and preventability of these ADRs were assessed using other standard criteria. Results A total of 327 ADRs were recorded for 320 participants, antibiotics were the class of drugs most commonly involved, and 76.15% of ADRs occurred within the first hour. The most common symptoms observed were skin manifestations, accounting for 46.04% of ADRs. Mild reactions accounted for 85.32% based on the Hartwig and Siegel scale. In 89.30% of the reports, the ADRs were evaluated as not preventable based on the modified Schumock and Thornton scale. The causality and severity of ADRs were related to Charlson Comorbidity Index score and age (P < 0.05). Conclusion This epidemiological study described the pattern of emergency infusion ADRs in East China in detail. These findings may be useful to compare patterns among different centers.

Causality, severity, and preventability of adverse drug reactions due to multi-drug therapy in leprosy: evidence from a national level institution in Sri Lanka

Objective This study describes the causality, severity, and preventability of adverse drug reactions (ADR) in patients affected by leprosy treated with multi-drug therapy (MDT) at the dermatology and central leprosy clinics of the National Hospital of Sri Lanka. Methods This cross-sectional analytical study consisted of two components (retrospective and prospective). Prospective cases were recruited and followed up for six months. Retrospective data collection was carried out at relevant clinics in the NHSL by extracting data from the clinical records of the patients. When an ADR was suspected, it was confirmed after discussion with the clinic medical officers/consultant dermatologist and scored according to the Naranjo ADR probability scale. The intensity of an individual ADR was evaluated using the modified Hartwig and Siegel Severity Assessment Scale, and preventability assessment was performed using the modified Schumock and Thornton scale. Results One hundred and ninety-seven patients were included for ADR attributable to MDT. Approximately 145 patients (73.6%) developed ADR associated with dapsone. Another 50 cases (25.3%) were associated with rifampicin, and 10 (5.1%) were associated with clofazimine. Of the dapsone related 145 ADRs, 59 (40.7%) were definite, 64 (44.1%) were probable, and 22 (15.2%) were possible. Of the rifampicin-related cases, four (8%) were definite, 35 (70%) were probable, and 11 (22%) were possible. The most common adverse drug reactions detected were haemolytic anaemia and hepatic abnormalities due to MDT. Dapsone was discontinued in 40% (59 out of 145) of these patients, while rifampicin was stopped in 8% (4 out of 50) of patients. Clofazimine was not stopped in any of the patients. Conclusions Adverse drug reactions associated with multidrug therapy in leprosy are common among patients diagnosed with leprosy in Sri Lanka. Most ADRs reported in this study were of mild severity and preventable. Careful monitoring and objective scales are needed to identify ADRs at an early stage.

To Assess Causality, Severity and Preventability of Adverse drug reactions of Amlodipine in the treatment of hypertension

Background: Every drug has the potentiality to cause an adverse drug reaction (ADR). ADRs are a major problem in drug therapy. The aim of this study was to assess the incidence and causality, severity and Preventability of ADRs Amlodipine (antihypertensive agents) used for the essential hypertensive patients during the time period of April 2022 to Jun 2022. Methods: This prospective-observational study was carried out in general medicine outpatient department in 15 Patients. Results: Out of 15 patients, 10 (66.66%) patients were developed ADRs to antihypertensive drugs. 8 (85.72%) were male and 2 (14.28%) were female. Calcium channel blockers were the commonest therapeutic class of antihypertensive drugs associated with ADRS (n = 50, 64.10%). According to WHO causality assessment scale most of the ADRs of Amlodipine were "probable" 8(57.14%) followed by "possible" 2 (14.28%), certain 4 (28.57%)). According to Hartwig and Siegel scale of severity assessment, the most of the adrs were mild 10(71.42%) and moderate 4 (28.57%). According to Schumock and Thornton scale of preventability assessment all ADR are definitely preventable. Conclusions: The results of this study concluded that antihypertensive drugs able to induce the development of adverse drug reactions, which were significant cause of increase burden on health care system and decrease the quality of life, the health care professionals should take care about the rational use of antihypertensive agents. Thus, to minimize the incidence of adverse drug reaction and to increase the quality of life.

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 &amp; 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 &amp; organ involved, causality assessment using WHO-UMC Scale and Naranjo's Algorithm, severity assessment using modified Hartwig &amp; Siegel’s scale and preventability by modified Schumock &amp; 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 &amp; 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.

Adverse drug reactions and correlations with drug-drug interactions: A retrospective study of reports from 2011 to 2020.

Introduction: Adverse drug reactions (ADRs) represent a public health problem worldwide that deserves attention due to the impact on mortality, morbidity, and healthcare costs. Drug–drug interactions (DDIs) are an important contributor to ADRs. Most of the studies focused only on potential DDIs (pDDIs), while the detailed data are limited regarding the ADRs associated with actual DDIs. Methods: This retrospective study evaluated ADRs reported between 2011 and 2020 in a tertiary hospital. The causality and severity of ADRs were evaluated through the Naranjo Algorithm and Hartwig’s scale, respectively. Preventability classification was based on the modified Schoumock and Thornton scale. For ADRs with at least two suspected drugs, pDDIs were identified according to the Lexi-Interact. We further checked whether the ADR description in the reports corresponded to the clinical consequences of the pDDIs. Results: A total of 1,803 ADRs were reported, of which 36.77% ADRs were classified as mild, 43.26% as moderate, and 19.97% as severe. The assessment of causality showed that the distributions of definite, probable, and possible categories were 0.33%, 58.68%, and 40.99%, respectively. A total of 53.97% of ADRs were identified as preventable ADRs, while 46.03% were recognized as unpreventable. The severity of ADRs was significantly correlated with age, the number of suspected drugs and preventability. Antimicrobial agents were the most common implicated pharmacological group, and the most frequently affected system was the gastrointestinal system. Considering individual drugs, aspirin was the most frequently reported drug. Among 573 ADRs with at least two suspected drugs, 105 ADRs were caused by actual DDIs, of which only 59 and 6 ADRs were caused by actual DDIs in category D and X, respectively. The most frequent drugs involved in actual DDIs of category D were aspirin and heparin, with the majority of ADRs being gastrointestinal bleeding. Conclusion: This study analyzed the pattern of ADRs in detail and obtained clinical evidence about ADRs associated with actual DDIs. These findings may be useful to compare patterns between different centers and to design preventive strategies for ADRs. Continuous education and training should be provided for physicians regarding the knowledge and recognition of ADRs associated with DDIs.

Adverse drug reaction profile of patients taking amantadine for traumatic brain injury in a tertiary care hospital

Background: Amantadine is found to be effective for the treatment of complications associated with traumatic brain injury. Drug-related side effects are common with Amantadine especially when combined with other drugs. Comprehensive information about the incidence and severity of these adverse effects is not available. Aim and Objectives: The aim of the study was to analyze the pattern of occurrence of adverse drug reactions (ADRs) in patients receiving Amantadine for traumatic brain injury in a tertiary care hospital. We also assessed the causality, severity, and preventability of ADRs. Materials and Methods: This prospective and cohort study was conducted among patients taking Amantadine for a continuous period of 1 month for traumatic brain injury in neurosurgery department between June 2020 and December 2020. Tools used were ADR Reporting form of National Pharmacovigilance Centre, WHO causality scale, Hartwig and Siegel scale, and Schumock and Thornton scale. Descriptive statistics were used and the values were expressed in numbers and percentages. Results: ADRs were experienced in 55 patients (36.7%) out of 150 patients and all the patients were on combination therapy. ADR was present more in male patients (63.6%) compared to females (36.4%). The most common ADRs were headache, ankle edema, and dry mouth. Majority of ADRs belonged to the possible category according to the WHO causality assessment scale. Majority of the ADRs (61.9%) were mild level 1 according to severity scale. All the ADRs came under the definitely or probably preventable category. Conclusion: ADRs with Amantadine are common but mild and preventable.

Patterns, causality, severity, and preventability of adverse drug reactions: An observational study at a tertiary health-care center

Background: Adverse drug reactions (ADRs) are among the top leading causes of death, adversely affect the quality of life by increasing hospital stay, treatment cost, and morbidity. Spontaneous reporting of ADRs by health-care professionals (HCP) helps in signal detection and enables regulatory agencies to formulate drug use guidelines, issue warnings, or even ban/withdraw the drug from the market. Dissemination of knowledge regarding the patterns of ADRs seen in adverse drug reaction monitoring centers (AMCs) among HCP will enable to promote awareness on ADRs, help in early detection, and encourage them to be more vigilant so as to prevent recurrence of ADRs. Aims and Objectives: We conducted an observational study, with the following objectives. The aim of the study was to determine the pattern of ADRs reported to AMC at PESIMSR, causality assessment, severity score, and preventability. Materials and Methods: We conducted an observational, retrospective, and questionnaire-based study in PESIMSR AMC, Department of Pharmacology. The study period was between January 2016 and December 2016. All ADRs reported to the AMC in the above period were collected by convenient sampling method. Data collected includes patient characteristics such as age, gender, details of the reaction, details regarding suspected drugs, treatment, and outcome of ADR details as outlined in the standard CDSCO ADR notification form. Data were entered in SPSS version 22. Descriptive statistics used and values are expressed in frequency and percentages. Results: A total of 153 cases were taken for analysis. Among them, 52% were males and 48% were females. The incidence of ADRs was higher (26%) among third and fourth decade than other age groups. Most frequent classes of drugs causing ADRs are antibiotics (44%) followed by analgesics (10%) and oral hypoglycemics (6%). The most frequently reported ADRs were cutaneous reactions. According to the WHO scale for causality assessment, 59% were possible ADRs. According to modified Hartwig Seigel’s severity assessment scale, about 16% were assessed as severe reactions. About 39% were probably preventable ADRs as assessed by modified Schummock and Thornton scale. Conclusion: Hospital-based ADR monitoring and reporting programs aim to identify and quantify the risks associated with the use of drugs. This study gives an insight to emphasize the awareness to the health-care providers on vigilant monitoring of ADRs and promptly reporting the same so as to prevent the occurrence of the reactions in vulnerable population.

Assessment of Adverse Drug Reactions of Antibiotics in General Surgical Patients of a Charitable Hospital

<p style="text-align: justify;"><strong>Objective:</strong> To study the Adverse Drug Reactions (ADRs) related to antibiotics in surgical patients. <strong>Materials and Methods:</strong> A prospective observational study was conducted in the General Surgery Department for six months. All surgical patients receiving antibiotic therapy were enrolled in the study, and necessary demographics details, diagnosis, suspected ADRs, and suspected drug details were documented. The scales Naranjo and WHO were used to determine ADRs&rsquo; causality, whereas severity and preventability were measured using Modified Hartwig and Siegel scale, Modified Schumock and Thornton scale, respectively. <strong>Results: </strong>There were 32 ADRs identified among 300 study subjects receiving antibiotic therapy, which had a male predominance of 68.75% and a higher occurrence in the age range of 40-49. Causality assessment based on the WHO-UMC criteria showed that 56.25% of ADRs were probable, whereas, by Naranjo&rsquo;s scale, 71.87% of ADRs were possible. Penicillins, Fluoroquinolones, and Cephalosporins were the most common antibiotics prescribed to induce ADRs (21.875%). The most frequently experienced ADRs were gastrointestinal reactions (65.625%) followed by skin reactions (28.125%). <strong>Conclusion: </strong>The occurrence of antibiotic-induced ADRs in the study is 10.66%. The study concluded that ADRs are indeed a major drugrelated problem affecting health outcomes and an issue that needs to be addressed vastly. It also emphasizes the importance of a clinical pharmacist in monitoring and reviewing the subjects&rsquo; treatment. <p style="text-align: justify;"><strong> Key words:</strong> Adverse Drug Reaction, Antibiotics, Assessment, Drug Safety, Pharmacovigilance.

A Prospective Study on Adverse Drug Reactions in Inpatients of General Medicine Department in a Tertiary Care Hospital- A clinical Pharmacist-led Study

The present study was carried out to determine the incidence of Adverse Drug Reactions (ADRs) in general medicine department and to assess and analyze the causality, severity, and preventability of ADRs. A prospective observational study was conducted in the general medicine department for six months. All patients receiving drug therapy are considered and are selected based on the inclusion criteria. Patient demographic details like age, gender, diagnosis, past medical history, concomitant medications, etc., are recorded from the patient data gathering form. The causality assessment is accomplished using Naranjo and WHO scales. The severity is carried out using the Modified Hartwig and Siegel scale. The preventability evaluation is accomplished using the Modified Schmock and Thornton scale. The study included 385 patients were between the age group of 18 years and, out of which 34 patients developed adverse drug effects including female and male. Patients between the age group of 40-50 years (18.1%) developed a high incidence of ADRs. The causality was assessed using Naranjo’s causality assessment scale, 44.1% reactions were probable; 29.4% reactions were certain, 23.5% reactions were possible and 2.9 % reactions were conditional. When the reactions were assessed most of them were assessed 55.1% were moderate and 61.8% were probably preventable. Appropriate observation of the drug effect is essential to ensure the safety of the patient. This also will have the advantage of reducing the incidence of the ADRs, thus deplete the complications and helps to improve the quality of life of the patients.

Preventability, predictability, severity and causality assessment of adverse drug reactions reported from a teaching hospital in chhattisgarh: A retrospective analysis.

Background and Objectives:Adverse Drug Reactions (ADRs) can lead to significant morbidity, rarely mortality and financial burden over the patient. ADRs that can be prevented can be considered as form of medication error sometimes. This study assessed the preventability, predictability and severity of ADRs using different assessment scales.Methods:ADR Monitoring Centre under newly established teaching hospital in Chhattisgarh collected ADR reports from different healthcare professionals during the period from November 2016 to November 2018. Analysis of the reported ADRs was done for their causality assessment, demographic details of patients, most common drug class responsible for the ADR. Seriousness and preventability of ADRs were analysed by using WHO Causality Scale and Modified Schumock and Thornton Scale respectively. Severity of ADRs was assessed by Modified Hartwig and Siegel Scale.Results:Totally 288 ADRs were reported in a 2-year period. 92.01% ADRs were non serious. 44.8% were mild, 53.81% moderate and 1.39% were severe ADRs. Causality assessment showed: 5.21% certain, 54.86% probable, 39.24% possible and 0.69% unlikely ADRs. Around 26% ADRs were definitely and probably preventable and 27.78% ADRs were predictable. The highest number (32.29%) of ADRs were reported to antimicrobials. 11.15% ADRs were reported to NSAIDs, in that 37.5% ADRs were due to NSAIDs combination.Conclusion:Many ADRs in this study are non-serious, preventable and predictable. Management of such ADRs through therapeutic interventions would be beneficial in a better patient outcome. Multidisciplinary strategies involving physicians, pharmacists, other healthcare professionals and patient education and awareness about ADRs are needed for prevention of ADRs.

Assessment of Causality, Preventability and Severity of Cutaneous Adverse Drug Reactions: A Prospective Observational Study

Background: All drug regulatory authorities have to ensure the safety, efficacy and quality of all the marketed products. Quality and efficacy can be determined by the data from preclinical and clinical trials. In clinical trials at the pre-marketing stage, it is challenging to identify rare Adverse reactions (ADR) and delayed side effects or effects due to long-term exposure because of lack of follow-up. In this case, pharmacovigilance comes into picture where it plays a significant role in marketed drugs safety profile establishment.&#x0D; Aim: This study helps in safety profile establishment for drugs.&#x0D; Methodology: It was conducted by the Department of pharmacy practice at drug information Centre in collaboration with Department of pharmacology at private multi-specialty Hospital. ADR reporting forms of the Central Drug Standard Control Organization has been used for collecting the data, and this form includes patient demographic details like clinical history, co-morbid conditions like Diabetes mellitus, Hypertension, Asthma, history of any drug allergies etc. were collected. The chance of preventability modified Schumock and Thornton criteria was found to be very less, and it was evident that most of them were not. By using Hartwig et al., scale, the severity of ADRs were of moderate severity. The reason behind this moderate severity was a history of allergy and multiple drug therapy.&#x0D; Result: It was observed that preventability 86% were not preventable whereas 14% were preventable as per Schumock and Thornton scale. In these cases of definitely preventable cases were due to history of reaction upon administration of the same drug. It is advised that in such cases usage of drug alert card is preferred.&#x0D; Conclusion: The major risk factor for the development of ACDR includes self-medication, patients’ lack of awareness regarding the dose and frequency of administration, polypharmacy. This can be avoided by prescribing the required drugs only and by educating the patients regarding the drugs.

ADVERSE DRUG REACTIONS IN PEDIATRIC PATIENTS IN A TERTIARY CARE HOSPITAL IN KOLLAM

Objective: Adverse drug reactions have not been as thoroughly studied in children as they have in adults. Extrapolation of efficacy, dosing regimens, and ADRs from adult data are inappropriate owing to developmental changes in physiology and drug handling. There is a lack of local data regarding the potential risk of ADRs in pediatric patients. Objective of this study is to identify the adverse drug reaction (ADR) profile in pediatric patients.&#x0D; Methods: In this cross-sectional study, 450 children attending the pediatric inpatient and outpatient department were selected, and the CDSCO reporting form for suspected ADR reporting forms was collected from those who had any adverse events by the consulting pediatrician. Later, this form was analyzed for the details for ADRs and assessed for causality, severity, and preventability using Naranjo’s algorithm, Hartwig and Siegel scale, and modified Schumock and Thornton scale of adverse drug reactions.&#x0D; Results: The cross-sectional study revealed a prevalence of 12.89%. Antibiotics caused more ADRs than any other group of drugs. Dermatological ADRs were the most common. Most ADRs were not preventable and were of moderate severity. The causality assessment showed that most ADRs were possible category.&#x0D; Conclusion: The ADRs are often unrecognized. We need more strict monitoring for early detection, treatment, and more importantly prevention of these events in the future. For that, more awareness programs, CMEs and teamwork are extremely important among the caregivers.

Appraisal of Inter-rater Agreement among Assessment Scales and Retrospective Analysis of Validated Reports of Cutaneous Adverse Drug Reactions at Tertiary Care Hospital in Eastern India

Introduction: Cutaneous Adverse Drug Reactions (CADRs) share significantly to Adverse Drug Reactions (ADRs) comprising 10%-30% of all ADR reporting in India. Multi Drug Therapy for Leprosy (MDT-L) and antimicrobials contribute remarkably to the overall CADRs burden. Aim: To show distinctive pictures of CADRs profile and to assess inter-rater agreement of assessment scales among study populations. Materials and Methods: A retrospective analysis was done for 245 CADRs reported from March 2018 to March 2020. Cohen kappa statistics was applied for inter-rater agreement study for causality (World Health Organisation-Uppsala Monitoring Cente {WHO-UMC} Scale and Naranjo’s Algorithm), severity (Hartwig and Siegel scale) and preventability assessment (Modified Schumock and Thornton scale). Results: CADRs contribute 45.54% of total ADRs reported during study period. Male (60.41%) and age group 21-40 years (22.45%) were predominant sex and age group, respectively. Multidrug therapy for leprosy (51.83%) was the most common offending agent and hyperpigmentation (20.82%), dryness (13.1%), and both (11%) were the most prevalent CADRs. Causality of WHO–UMC Scale was higher with ‘Possible’ than ‘Probable’. Whereas, ‘Probable’ was maximally found with Naranjo’s Algorithm. Severity assessment showed maximum ‘mild’ cases i.e., 66.53% (manual) and 69.8%% (app). Preventability assessment depicted mostly ‘Definite’, 66.53% (manual) and 85.71% (app). Inter-rater agreement study showed ‘Substantial agreement’ for WHO-UMC Scale (K=0.678) and Naranjo’s algorithm (K=0.820), when manual vs app ratings were compared. ‘Almost perfect’ for severity assessment (K=0.893) and ‘Moderate’ for preventability assessment (K=0.434) were noticed. ‘Fair’ agreement was observed when manual (WHO-UMC scale) vs manual (Naranjo’s algorithm) were compared with K=0.290 and also, in app (WHO-UMC scale) vs app (Naranjo’s algorithm) with K=0.319. Conclusion: CADRs were most prevalent among ADRs which have a distinctive picture in eastern India. WHO- UMC scale and Naranjo’s algorithm concluded significant differences in causality with only ‘fair’ agreement between them. Severity and preventability assessment done by manually little varied in their results with pharmvigill app and is still more reliable and popular.

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.

A Retrospective Descriptive Study of Adverse Drug Reaction Monitoring in Tertiary Care Hospital

ABSTRACT Introduction An adverse drug reaction (ADR) is any undesirable effect of a drug to the patient beyond its anticipated therapeutic effects while used clinically. Aims and objective To analyze the incidence of ADRs in a tertiary care hospital reported from April 2015 till December 2017. Materials and methods Two hundred ADR forms were included in the study and analyzed. These were codified into various drug classes according to anatomical therapeutic chemical (ATC) classification based on WHO–ATC Index 2019 besides categorized into preventable or not modified Schumock and Thornton scale. Severity was assessed based on a scale by Hartwig et al. Also, the ADRs were classified based on MedDRA 13.01 to system organ class (SOC) and preferred terms (PT) falling under respective SOC. Results Maximum ADRs were reported by dermatology. Most commonly, it involved gastrointestinal system (GIT) followed by skin. Antibiotics and anti-cancer drugs caused maximum ADRs. About two-thirds were classifiable as moderate to severe, whereas about one-third were preventable. About 10% of cases were such that left deep impact of sequelae or were not recovered and one case was fatal. Conclusion Extreme vigilance by clinicians is of utmost crucial virtue in detecting, diagnosing, and reporting such ADR for continued drug safety monitoring. How to cite this article Gupta AK. A Retrospective Descriptive Study of Adverse Drug Reaction Monitoring in Tertiary Care Hospital. J Med Acad 2020;3(2):54–58.

Adverse Drug Reaction due to Antidepressants among Patients with Depression in a Private Psychiatric Hospital of Nepal.

Background Adverse drug reactions (ADRs) are the known cause of morbidity and mortality, resulting in increased hospitalization, healthcare costs, complications, and decreased adherence in patients with depression. This study is aimed at evaluating adverse drug reactions due to antidepressants among patients with depression in the psychiatric hospital of Nepal. Methods A hospital-based prospective observational study was conducted among 47 patients using purposive sampling techniques among patients with depression visiting a private psychiatric hospital. The causality, severity, and preventability assessment of reported ADRs was performed using the Naranjo scale, modified Hartwig Siegel's Severity Assessment Scale, and Schumock and Thornton scale, respectively. The data collected were entered into and analyzed using IBM-SPSS 20.0. Results The incidence rate of ADR was found to be 4.54%, with females having a higher incidence rate of 5.56%. A total of 54 ADRs were reported. The majority of them were probable (30, 55.55%), moderate (36, 66.66%) and probably preventable (24, 44.44%). Most of the ADRs were managed either by stopping (19, 35.18%) or substituting (19, 35.18%) the suspected drug and 66.66% of the ADRs were recovered. Selective serotonin reuptake inhibitors (SSRIs) were associated with a higher number of ADRs i.e. 34. Conclusion The findings highlight the need for regular intensive monitoring of ADRs in psychiatric outpatients by clinical pharmacists for early detection and reduction of risk caused by ADRs associated with antidepressants.

Adverse Drug Reactions and its Management Associated with Cancer Chemotherapy

Adverse Drug Reactions () are the problem that adds extra burden in the global scenario. Anticancer drugs can lead to severe negative consequences due to these . This study was conducted to assess the causality, severity and preventability of the identified of chemotherapeutic drugs among hospitalized patients diagnosed with cancer and also to analyze its management. A prospective observational study was conducted among cancer patients for a period of eight months. A total of 120 hospitalized patients who developed at least one ADR due to chemotherapy were included in this study. Data were collected and documented in a well-designed data collection form. A total of 166 were detected in 120 patients. 33(19.8%), was found as the most commonly identified ADR. Patients administered with as were found to be reported with the highest number of (36). According to Naranjo’s scale and WHO causality assessment, 110(66.2%) and 105(63.2%) were found probable. &amp;amp; scale of severity showed that 97(58.4%) were moderate and Modified and Thornton scale revealed that 129(77.7%) were not preventable. The patients prescribed with , , regimen should be strictly and continuously monitored for the symptoms of ADR. Early detection of ADR can decrease morbidity and mortality.