Assessment Of Adverse Drug Reactions Research Articles

The assessment of severe cutaneous adverse drug reactions.

SUMMARYSevere cutaneous adverse drug reactions include Stevens-Johnson syndrome, toxic epidermal necrolysis and acute generalised exanthematous pustulosis. These eruptions are a type of delayed hypersensitivity reaction and can be life-threatening.The assessment of a severe cutaneous drug reaction requires a detailed clinical history and examination to identify the culprit drug and evaluate the allergy. Allopurinol, antibiotics and anticonvulsants are often implicated.Patch testing and delayed intradermal testing can assist in determining if the reaction was allergic, however there is limited evidence about the sensitivity and specificity of skin testing in severe cutaneous adverse drug reactions. If the testing is non-conclusive or negative, it is recommended to avoid the suspected culprit drug and any structurally similar drug in future.Any decision to reintroduce a drug should be made after considering the harm–benefit ratio. Caution is also needed if considering a possibly cross-reactive drug in a patient with a history of severe cutaneous adverse drug reactions.

A pharmacogenomic assessment of psychiatric adverse drug reactions to levetiracetam.

ObjectiveLevetiracetam (LEV) is an effective antiseizure medicine, but 10%–20% of people treated with LEV report psychiatric side‐effects, and up to 1% may have psychotic episodes. Pharmacogenomic predictors of these adverse drug reactions (ADRs) have yet to be identified. We sought to determine the contribution of both common and rare genetic variation to psychiatric and behavioral ADRs associated with LEV.MethodsThis case‐control study compared cases of LEV‐associated behavioral disorder (n = 149) or psychotic reaction (n = 37) to LEV‐exposed people with no history of psychiatric ADRs (n = 920). All samples were of European ancestry. We performed genome‐wide association study (GWAS) analysis comparing those with LEV ADRs to controls. We estimated the polygenic risk scores (PRS) for schizophrenia and compared cases with LEV‐associated psychotic reaction to controls. Rare variant burden analysis was performed using exome sequence data of cases with psychotic reactions (n = 18) and controls (n = 122).ResultsUnivariate GWAS found no significant associations with either LEV‐associated behavioural disorder or LEV‐psychotic reaction. PRS analysis showed that cases of LEV‐associated psychotic reaction had an increased PRS for schizophrenia relative to contr ols (p = .0097, estimate = .4886). The rare‐variant analysis found no evidence of an increased burden of rare genetic variants in people who had experienced LEV‐associated psychotic reaction relative to controls.SignificanceThe polygenic burden for schizophrenia is a risk factor for LEV‐associated psychotic reaction. To assess the clinical utility of PRS as a predictor, it should be tested in an independent and ideally prospective cohort. Larger sample sizes are required for the identification of significant univariate common genetic signals or rare genetic signals associated with psychiatric LEV ADRs.

Efficacy and safety of phenytoin versus clobazam as monotherapy for newly diagnosed epileptic patients

Background: Epilepsy is a chronic disorder characterized not only by recurrent seizures but also by a great variety of medical and psychosocial implications. Its burden to the patients and their families has been recognized and even the impact upon the community is vast. Aims and Objectives: The aim of the study was to compare the efficacy and safety of phenytoin and clobazam in monotherapy for the management of new onset, untreated epileptic patients. Materials and Methods: A 6 months, observational, comparative study was conducted on 60 adult patients with epilepsy. The eligible patients were given either phenytoin sodium (Group A; n=30) in a loading dose of 15 mg/kg orally, followed by 5 mg/kg/day maintenance dose for 6 months while Group-B (n=30) received clobazam in a dose of 1 mg/kg oral loading dose followed by 0.5 mg/kg/day. Seizure frequency was evaluated and compared with baseline at 1, 2, 3, 4.5, 6 months along with adverse drug reaction assessment. Results: In Group A mean pre-treatment baseline seizure frequency was 6.3±2.19 and for Group B 5.80±2.22. After 6 months, seizure frequency for Group A 2.30±1.99 and in Group B 1.30±1.91. In Group B, there was a significantly higher reduction in seizure frequency (P=0.001) than that of Group A. Both the drug groups significantly reduced the seizure frequency but Group B was found to be superior. Adverse drug reaction was more in Group A in comparison with Group B. The common side effects were drowsiness, weight gain, headache, tiredness, nausea and ataxia. Conclusion: Clobazam monotherapy had demonstrated better efficacy than phenytoin for the treatment of epilepsy and also well tolerated.

Molecular Fingerprinting by Single Cell Clone Analysis in Adverse Drug Reaction (ADR) Assessment.

Causality assessment for idiosyncratic ADRs mainly relies on epidemiology, signal detection and less often on proven or plausible mechanistic evidence of the drug at a cellular or organ level. Distinct clones of cells can exist within organs of individual patients, some conferring susceptibility to well-recognised Adverse Drug Reactions (ADRs). Recent advances in molecular biology have allowed the development of single-cell clonal techniques, including single-cell RNA sequencing (scRNA-seq) to molecularly fingerprint ADRs and distinguish between distinct clones of cells within organs in individuals, which may confer differing susceptibilities to ADRs. ScRNA- seq permits molecular fingerprinting of some serious ADRs, mainly in the skin, through the identification of Directly Expressed Genes (DEG) of interest within specific clones. Overexpressed DEGs provide an opportunity for targeted treatment strategies to be developed. scRN A-seq could be applied to a number of other ADRs involving tissues that can be biopsied/sampled (including skin, liver, kidney, blood, stem cells) as well as providing a molecular basis for rapid screening of potential therapeutic candidates, which may not otherwise be predictable from a class of toxicity/organ involvement. A framework for putative assessment for ADRs using scRNA-seq is proposed as well as speculating on potential regulatory implications for pharmacovigilance and drug development. Molecular fingerprinting of ADRs using scRNA-seq may allow better targeting for enhanced pharmacovigilance and risk minimisation measures for medicines with appropriate benefit-risk profiles, although cost-effectiveness and other factors, such as frequency/severity of individual ADRs and population differences, will still be relevant.

Oxaliplatin Induced Severe Hypoxemia, Chills and Hypersensitivity Reaction

Hypersensitivity reactions to platinum containing compounds are well described and potentially life threatening. The hypersensitivity reactions can occur either during, or shortly after the infusion of drug. The incidence increases with increase in the number of chemotherapy cycles. Hypersensitivity reactions can vary from mild reactions like rashes to severe reactions, which include laryngospasm, tachycardia, hypotension or hypertension. The combination of 5-flurouracil, leucovarin and oxaliplatin has been used in several studies to increase survival rates and reduce the risk of disease progression in patients with metastatic colorectal cancer (CRC) and stage III colon cancer. We report a case of patient treated with oxaliplatin who developed Severe Grade-III Toxicity including Hypoxemia, Chills and hypersensitivity reaction like rashes all over the body with itching sensation about few hrs after the oxaliplatin infusion. Patient tolerated 7 cycles of FLOT chemotherapy well. During cycle 8 chemotherapy after 50% infusion of oxaliplatin patient developed severe reaction to oxaliplatin such as breathlessness, shivering, hypersensitivity reaction like rashes all over the body and itching sensation. The drug infusion was stopped immediately, vitals were checked which shows BP: 170/110mmhg, Temperature 100⁰F, Spo2 85% RA. It was confirmed as grade 3 toxicity of oxaliplatin. The adverse drug reaction assessment was done using Naranjo’s causality assessment scale which showed ‘definite’ type of adverse drug reaction with oxaliplatin. Prompt recognition of this event and symptomatic treatment with supplemental oxygen and corticosteroids and prolonging the infusion time of oxaliplatin can lead to better patient compliance and lesser hypersensitivity reactions to these regimens.
 Keywords: Oxaliplatin, Colorectal cancer (CRC), Dyspnoea, Hypersensitivity reactions, Chemotherapy.

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.

Assessment of the Radio-contrast Media-Induced Self-Reported Adverse Drug Reactions in a Tertiary Care Hospital of North India: A Prospective Study.

Background:Radio-contrast media are the agents which are used on daily basis in the radiological practice for either diagnostic or therapeutic purpose. Currently used agents are considered to be safe but not devoid of side effects.Objectives:Objectives of the study were to assess the incidence of adverse drug reactions (ADRs) in the patients who receive radiographic contrast media for computed tomography (CT) and intravenous pyelography (IVP), to stratify the ADRs into different types based on their time of appearance and as per their severity.Materials and Methods:A prospective and observational study of 1-year duration was done on all the patients who received radio-contrast media (Iohexol) intravenously for CT and IVP in the radiodiagnosis department. Patients who experienced ADRs were recorded for the basic demographic characteristics and types of ADRs. Stratification of ADRs as per their severity was done using common terminology criteria for adverse events scale and Modified Hartwig and Siegel ADR Severity Assessment Scale, and casualty assessment was done using Naranjo's Algorithm.Results:Out of the total 3522 patients who were included in the study, eight patients got 12 suspected ADRs with some of the patients having more than one type of ADR. The most frequent ADR was nausea and vomiting (25%), followed by fever, chills, or sweating. Incidence of ADRs was 0.23%. All the ADRs were acute and occurred within 30 min of contrast administration. As per the severity scales used, all the ADRs were mild (75%) to moderate (25%) in nature with none of the reactions to be severe. Causality assessment showed 87.5% of the reactions to be “probable” in nature.Conclusion:Low osmolar nonionic radio contrast media are associated with very low incidence of ADRs in the North Indian population.

Study of pattern &amp; distribution of adverse drug reactions in acute coronary syndrome patients in a tertiary care hospital

With the availability of a wide range of drugs to treat patients with acute coronary syndrome (ACS), adverse drug reactions (ADRs) have become inevitable in clinical practice. Thorough knowledge of such reactions is essential for the treating physician for optimal treatment and better outcomes. There are many scales to define, measure and assess the ADRs, but there is a dearth of data available on such drug reactions among ACS patients. Hence, this study attempted to analyze the pattern, causality, severity, predictability and preventability of ADRs in ACS patients. All the ADRs reported during the study period were analyzed for causality by the World Health Organization-Uppsala Monitoring Centre (WHO-UMC), Naranjo's and Karch and Lasagna scales; severity by modified Hartwig and Siegel scale; predictability by Rawlins and Thompson criterion and preventability by Schumock and Thornton scale. A single-centre, record-based analysis for the occurrence of ADRs was done among ACS patients admitted to the department of Cardiology between January and October 2017. Demographic data, comorbid conditions, reported ADRs and ADR assessment details were noted from the hospital case records and ADR monitoring centre (AMC) records. The data were analyzed and presented in a descriptive manner using percentages, mean and standard deviation. The Pearson's chi-squared test was used to ascertain the significance of the association between different groups. Out of 324 patients under evaluation, 67 had developed one or more ADRs. There were 30 different types of ADRs reported, headache being the most common. Among the drugs, heparin was the most common factor, causing 27 per cent of ADRs. Definite causality of a suspected drug causing ADRs was seen in 11.9 (n=8), nine (n=6) and 7.5 (n=5) per cent cases as per WHO-UMC, Naranjo (Naranjo algorithm) and Karch and Lasagna scales, respectively. In the severity of ADRs, the most severe reactions according to the modified Hartwig-Siegel scale (level 4a in our study) were seen in 17.5 (n=12) per cent of patients, and the rest were either level 2 or 3 reactions. Nearly 92.5 (n=62) per cent of reactions were predictable according to the Rawlins and Thompson criterion. Application of the modified Schumock-Thornton scale showed that 22.4 per cent of ACS patients had preventable reactions, and the rest were not preventable. The study results suggest that ADRs are relatively common among ACS patients. Most of these can be identified and assessed for causality, severity, predictability and preventability using various available scales. Diligent pharmacovigilance for identifying and assessing ADRs may help manage and mitigate morbidity associated with these in high-risk ACS patients.

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.

Assessment and Management Pattern of Chemotherapeutic Drug Induced Adverse Effects among Cancer Patients at Tertiary Care Centre

Aim and Objective: Cancer chemotherapy drugs causes substantial toxicity and produces number of adverse effects which can significantly reduce patient's health related quality of life. The aim of this study was to perform the assessment and explore the management practice of chemotherapy induced side effects among cancer patients.&#x0D; Material and Methods: Demographic characteristics of patient undergone cancer chemotherapy and adverse drug reactions (ADRs) of chemotherapeutic drugs were noted in patient's case report form. Assessments of ADRs were performed for Severity, Causality and Preventability of each ADR. Association between occurrence of severe ADRs and patient' characteristics were studied using chi square statistics. Frequencies of ameliorative therapy were studied in each patient.&#x0D; Results: 120 patients were selected and included in the study and a total of 412 ADRs were detected after cancer chemotherapy. Majority (60%) of the participant were female. Most common cancer was found as breast cancer (23%). Commonly used chemotherapy regimens were combination of carboplatin and paclitaxel (14%). Upon severity assessment of ADR, more than one third categorized as "Severe" ADR (36.4%). Majority of the Severe ADR were alopecia and nausea &amp; vomiting. Most of the ADRs (73%) on preventability assessment were found as Not-Preventable. There is a significant association between occurrence of severe ADRs and age, sex &amp; chemotherapy regimen. Combination of palonosetron, dexamethasone and pantoprazole were used as ameliorative therapy (43.3%).&#x0D; Conclusion: Cancer chemotherapy drugs produce numerous adverse effects. Assessment of severity of ADRs and associated triggering factor may support in management practice of side effects.

An unusual presentation of pemphigus foliaceus following COVID‐19 vaccination

An unusual presentation of pemphigus foliaceus following COVID‐19 vaccination

Risk Assessment Of Adverse Drug Reactions In Elderly Patients With Chronic Diseases

Introduction: The adverse drug reaction (ADR) is 4-7 times more common in elderly patients. That was also related to changes in pharmacokinetics and pharmacodynamics that triggered the emergence of Drug-Related Problems. Objective: The purpose of this study was to assess ADR in elderly patients with chronic diseases using the GerontoNET Score and the Screening Tool of Older People's Prescriptions (STOPP) criteria. Methods: The research design used a cross-sectional study which was analyzed descriptively. The sample consisted of 72 patients, aged more than 60 years, accompanied by chronic diseases, and hospitalized at Waluyo Jati Kraksaan Hospital. The exclusion criteria were patients referred to the Intensive Care Unit. Assessment to see the risk of ADR in elderly patients with chronic diseases using the GerontoNet Score while the wrong type of drug is given to elderly patients using the STOPP criteria. The variables contained in the GerontoNET Score are comorbid conditions ³4 (score= 1), heart failure (score= 1), liver disease (score = 1), the number of drugs such as: £5 (score= 0); 6-7 (score=1); ³8 (score=4), history of ADR (score=2), kidney failure (score=1). Results: The variable with the most ADR risk factors was the number of drugs ³8 drugs as many as 47 patients (65.3%) with GerontoNET score ³4 as much as 70.8%. The types of drugs included in the STOPP criteria are clopidogrel, Arixtra (fondaparinux), beta-blockers, NSAIDs, and furosemide. Conclusion: The risk factor for ADR was the number of drugs ³8 drugs.

Knowledge and Perception of Pharmacy Practice Students on Causality Assessment of Adverse Drug Reactions

Pharmacy Practice students play an important role in identifying and reporting Adverse Drug Reactions (ADRs). Prior studies focused on knowledge of pharmacy students on reporting ADRs. There are no studies conducted to assess the knowledge and understand the perception of students on causality assessment of ADRs. A web-based cross-sectional study was conducted from October 2019 to April 2020 among the Pharmacy Practice students in various pharmacy colleges across India. Consent form was obtained before filling the questionnaire. The questionnaire was distributed through social media applications and staff of respective colleges. Descriptive analysis was performed to calculate frequencies and percentages of categorical variables. A total of 723 students, 608 responses were received from 30 pharmacy colleges across India. The mean age (SD) of participants was 22.95 (1.61) years. The majority of responses were received from females (70.39). The majority of participants (90.78%) were aware of various causality assessment scales. More than half (58.55%) strongly agreed that there is a need for hands on training on causality assessment of ADRs at college level. Around 80% of the participants strongly agreed that clinical pharmacist is necessary in the healthcare team for causality assessment of ADRs. The knowledge of students on causality assessment of ADRs was found satisfactory. Students believed that having regular workshop on causality assessment of ADRs may help improve their skills in identifying the suspected medications that caused ADRs and helps in better patient care.

Causality assessment of adverse drug reactions by applying a global introspection method in a high complexity hospital

BackgroundCausality assessment of adverse drug reactions (ADRs) is an essential approach in pharmacovigilance. The World Health Organization-Uppsala Monitoring Center (WHO-UMC) system has been considered one of the most adequate method for establishing causal relationship in hospitalized patients. ObjectiveTo describe the causality of potential ADRs in hospitalized patients assessed by the WHO-UMC system and by different healthcare professionals. MethodsThree healthcare professionals, with different backgrounds, acted as judges to adjudicate the causality categories for potential ADRs according to WHO-UMC system, in a Brazilian high complexity hospital. Judges' agreement was evaluated by using Fleiss' and Cohen's kappa coefficients. ResultsNinety potential ADRs identified in 300 participants were adjudicated by each judge, comprising a total of 270 assessments. Most potential ADRs were classified as probable or possible (77.8%). Fleiss´ kappa revealed slight concordance among judges (k = 0.096;CI:95%;0.01–0.18). ConclusionsDiverse backgrounds may have influenced the results for causality assessment of ADRs by employing the WHO-UMC system. Despite the slight concordance found for the method, this result suggests potential opportunity to enrich the ADRs management by engaging multiprofessional teams in the process. Further studies should be considered to investigate the performance of methods for ADRs assessment in hospitalized patients in low- and middle-income countries.

Agreement between WHO-UMC causality scale and the Naranjo algorithm for causality assessment of adverse drug reactions.

Background:The Pharmacovigilance Program of India recommends the use of the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale, while many clinicians prefer the Naranjo algorithm for its simplicity. In the present study, we assessed agreement between the two widely used causality assessment scales, that is, the WHO-UMC criteria and the Naranjo algorithm.Materials and Methods:In this study, 842 individual case safety reports were randomly selected from 1000 spontaneously reported forms submitted to the ADR Monitoring Center at a tertiary healthcare Institute in Central India between 2016 and 2018. Two well-trained independent groups performed the causality assessment. One group performed a causality assessment of the 842 ADRs using the WHO-UMC criteria and the other group performed the same using the Naranjo algorithm. The agreement between two ADR causality scales was assessed using the weighted kappa (κ) test.Results:Cohen's kappa coefficient (κ) statistical test was applied between the two scales (WHO-UMC scale and Naranjo algorithm) to find out the agreement between these two scales. “No” agreement was found between the two scales {Kappa statistic with 95% confidence interval = 0.048 (P < 0.001)}.Conclusion:There was no agreement found between the WHO-UMC criteria and the Naranjo algorithm in our study.

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.

Translation, transcultural adaptation and validation to Brazilian Portuguese of tools for adverse drug reaction assessment in children

BackgroundChildren are more vulnerable to adverse drug reactions (ADRs) due to complex changes in the body during the growth process and lack specific pharmacoepidemiologic studies. Causality and Avoidability assessment of ADRs are relevant to clinical guidelines development and pharmacovigilance. This study aimed to translate and transcultural adapt two new tools—Liverpool Causality Assessment Tool (LCAT) and the Liverpool Avoidability Assessment Tool (LAAT)—to Brazilian-Portuguese and evaluate the psychometric properties of these tools to analyse ADRs in Brazilian children.MethodsThe validation of the cross-cultural adaptation of tools was obtained by the functional (conceptual, semantic, operational, and measurement) equivalence between the original and translated versions of each instrument. The translated version of LCAT and LAAT was applied to assessing the twenty-six case reports of suspected adverse drug reactions in a Brazilian teaching paediatric hospital. The inter-rater reliability (a pharmacist and a physician) was evaluated using Cronbach’s alpha. The exact agreement percentages (%EA) and extreme disagreement (%ED) were computed. Overall Kappa index was calculated with a 95% confidence interval.ResultsThere was a need to modify some terms translated into Portuguese for semantic and conceptual equivalence. The Cronbach’s alpha coefficient values obtained were 0.95 and 0.85, and the weighted Kappa (95% confidence interval) were 0.82 (0.67–0.97) and 0.68 (0.45–0.91) for LCAT and LAAT, respectively. The Brazilian-Portuguese versions of the LCAT and LAAT showed reliable and valid tools for the diagnosis and follow-up of ADRs in children.ConclusionThe methodological approach allowed the translation, transcultural adaptation, and validation to Brazilian-Portuguese of two easy and quick to perform tools for causality and avoidability of ADRs in children by a multidisciplinary expert specialist committee, including the authors of original tools. We believe these versions may be applied by professionals (patient safety teams) and researchers in Brazil in groups or by a single reviewer.Trial registrationThis study was evaluated and approved by the Research Ethics Committee (Instituto de Pediatria e Puericultura Martagão Gesteira – Federal University of Rio de Janeiro – Number: 3.264.238.

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 Adverse Drug Reactions of Psychopharmacological Drugs in Patients of Psychiatric Disorders

Assessment of Adverse Drug Reactions of Psychopharmacological Drugs in Patients of Psychiatric Disorders

Assessment of Adverse Drug Reactions of Psychopharmacological Drugs in Patients of Psychiatric Disorders

Assessment of Adverse Drug Reactions of Psychopharmacological Drugs in Patients of Psychiatric Disorders