Outcome Of Adverse Drug Reactions Research Articles

EFFECTIVENESS AND SAFETY PROFILE OF TNF ALPHA INHIBITORS IN REFRACTORY SPONDYLOARTHOPATHIES: AN OBSERVATIONAL STUDY.

Background About 40% patients of Ankylosing Spondylitis (AS) are refractory to rst line therapy. This observational longitudinal study evaluated the effectiveness and safety of iniximab, a TNF alpha inhibitor in refractory AS in an Indian cohort. Methods Adult AS patients who were prescribed iniximab were enrolled. Clinical effectiveness was assessed by changes in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score from baseline to study end visit. Safety was assessed by observing the frequencies, type, severity and outcome of adverse drug reactions. Results 31 adult AS patients with mean age of 33.84 yr were enrolled. 67.74 % had >5 years disease duration. 29%, 42%, 26%, 3% received 1, 2, 3 and 4 doses of iniximab respectively. The BASDAI scores were signicantly reduced from baseline values in all patients (p<0.0001) and 55 % of the patients achieved >50% reduction of the baseline BASDI score at 6 months. 35% of the cohort reported at least one ADR and none were serious in nature. Conclusion Iniximab is an effective, safe biologic and provides a statistically as well as clinically signicant reduction in disease activity scores in refractory AS patients. A larger cohort size and longer follow up period shall provide further insights in this regard

Incidence of adverse drug reaction and its outcome among patients in tertiary care hospital, Uttar Pradesh

Introduction: World Health Organization defines adverse drug reactions (ADRs) as any noxious, unintended, and undesired effect of a drug, which occurs at doses used in humans for prophylaxis, diagnosis, or therapy. For evaluating the incidence and outcome of adverse drug reactions (ADRs) to assist in minimizing the deleterious effects, the present study was planned to find the incidence of ADR, its severity, and outcomes among patients. Material and Methods: The spontaneous ADR reporting technique and the Suspected Adverse Drug Reaction Reporting Form were used for the data collection and reporting. All patients who developed an ADR during the study period has included. By using Expanded Rawlins and Thompson’s classification, all patients were categorized into types A to F and classified according to the severity levels (mild, moderate, severe) by applying the Modified Hartwig severity scale. The classification of outcomes of the ADRs was done as per WHO criteria as fatal, continuing, recovering, recovered, unknown, or any other. Results: Type B (Bizarre) ADRs were found to be the most frequently occurring ADRs (51%) followed by type A (Augmented) 29%. Maximum ADR cases were found in the 12-45 years age group (58%).

Incidence and outcomes of adverse drug reactions to first-line anti-tuberculosis drugs and their effects on the quality of life: A multicenter prospective cohort study.

In tuberculosis (TB) treatment, adverse drug reactions (ADRs) can interrupt treatment and decrease the quality of life (QoL). We aimed to prospectively investigate the incidence of ADRs to first-line anti-TB drugs and related outcomes and QoL. Adult patients with TB who had been treated with first-line anti-TB drugs in five Korean hospitals were enrolled. ADR questionnaire surveys and blood tests were performed four times serially, and QoL was assessed on the fourth TB treatment week (±2 weeks). Of 410 enrolled patients with TB (males, 62%; mean age, 52.1 ± 18.1 years [those aged ≥65 years, 26.6%]), 67.8% experienced any ADRs (≥ grade 2) to TB drugs. The most common ADR was fatigue (53.2%), followed by itching (42.7%) and anorexia (41.7%). Older adult patients experienced relatively more ADRs, including anorexia, dyspepsia, rash, dizziness, anemia, abnormal hepatic/renal function tests, and increased uric acid levels (p < 0.05). Treatment regimens changed for 9.5% of patients owing to ADRs to anti-TB drugs. Patients with any ADRs and older adult patients had significantly lower QoL than their counterparts (p < 0.05). Old age (odds ratio [OR], 1.02) and being male (OR 2.65) were independently associated with ADRs, whereas active smoking (OR 4.73) and a relatively long treatment phase (OR 5.13) were independently associated with hepatotoxicity. ADRs to first-line anti-TB drugs were common and related to relatively low QoL, especially among older adults. Although 9.5% of patients had ADR-related regimen changes, most patients with ADRs completed treatments successfully.

The evaluation of adverse drug reactions in Saudi Arabia: A retrospective observational study

PurposeThis study aimed to assess the type, severity, seriousness, reasons, and outcomes of adverse drug reactions (ADRs) in the reports submitted to the regional spontaneous ADR database. MethodsA retrospective observational study was conducted to analyze all the Tabuk Health Affairs hospitals in Saudi Arabia submitted to SFDA from January 2020 to December 2020. The database was structured according to the Saudi ADR form’s fields. The Naranjo algorithm was used to assess the causes of the ADRs (sFDA, 2022). ResultsFor 1 year, 2,349 ADR reports, along with 242 suspected drugs for 4,114 reactions, were submitted to SFDA. We found more males than females had ADRs (56.1% vs. 43.8%, P < 0.05).Antimicrobial drugs (26.9%), hematologic drugs (19.7%), and neuropsychiatric drugs (12.9%) were responsible for most ADRs. Most of the reactions were associated with the use of ciprofloxacin (7.7%), followed by the combination of lopinavir and ritonavir (4.1%). Two deaths resulted from salbutamol and cefazolin use. Based on the results of the Naranjo assessment of causality, cardiovascular events (9.9%) exhibited the highest score (≥9) for a causal relationship with the suspected drugs, followed by dermatological events (9.5%). ConclusionsThe spontaneous report database is an important and valuable source of aftermarket authorization safety information. In our study, most drugs used as antimicrobial, cardiovascular, and hematologic therapies were associated with a higher risk of developing severe and serious events. We recommend monitoring and using medications optimally to ensure patient safety.

Characterisation of seriousness and outcome of adverse drug reactions in patients received cancer chemotherapy drugs – A prospective observational study

Background: Cancer chemotherapeutic drugs are commonly associated with serious adverse effect which contributes to increase in the duration of hospitalisation and economic burden. Aim: The aim of this study was to characterise the seriousness and outcome of adverse drug reactions (ADRs) produced by chemotherapy drugs in cancer patients.Materials and Methods: Patient''s demographic characteristics and ADRs due to chemotherapeutic drugs were documented inpatient case report form. Frequencies of the seriousness of the ADRs, its outcome and preventability were studied using descriptive statistics. Proportion of life-threatening ADRs and ADRs linked to increase in duration of hospitalisation were studied. Factors associated with serious ADRs and patient characteristics were studied using calculation of odds ratio (OR) at 95% confidence interval (P < 0.5).Results: A total of 412 ADRs were noted in selected 120 patients received chemotherapy drugs. Majority of ADRs (61%) were linked to increase in duration of hospital admission. Some ADRs (12%) were noted as life-threatening to the patients. OR 1.58 was found on the association between patient age group and serious ADRs (P = 0.02). Association of preventability of ADRs and serious ADRs shows OR of 3.65 (P = 0.0001). Common serious ADRs were noted as anaemia, neutropenia, fever, thrombocytopenia, diarrhoea, mucositis and nausea and vomiting.Conclusion: The incidence of serious ADRs due to chemotherapy drugs amongst cancer patients is high. Studies on the nature of seriousness of ADRs, outcome and its triggering factors may help to prevent them. Early identification of serious ADRs may support to reduce hospital stay and economic burden.

COMPARATIVE REVIEW OF METHODOLOGIES FOR ESTIMATING THE COST OF ADVERSE DRUG REACTIONS IN THE RUSSIAN FEDERATION AND BRAZIL

The aim of the review article was to highlight the methodologies for assessing the financial costs of adverse drug reactions exemplified by the Russian Federation and Brazil.Materials and methods: for a comparative analysis, materials from open sources were used. The study of the experience of methods used for assessing the burden of adverse drug reactions, was carried out using the system for calculating payments for medical care by clinical-statistical and clinical-profile groups, the methodology for assessing the severity of adverse events of the US National Cancer Institute, drug-associated problems, and “the decision tree” model.Results. When comparing the costs of ADR management in the Russian Federation and Brazil, the following results have been obtained: in the Russian Federation, the “cost” of reaction can be estimated only for a limited number of nosological groups that are regulated by the classification of diseases by clinical and statistical groups; in Brazil, when predicting the costs of adverse reactions management, the combination of “the decision tree” method and the Delphi method is used. In the Russian Federation, the cost of the 3rd and above severity adverse event (according to CTCAE v. 4.03), varies from 26,849.22 up to 26,196.37 RUB in the North-West region (St. Petersburg). In Brazil, the cost of ADR ranges from 13 USD (the best scenario for the patient) to 574 USD (the worst scenario for the patient), which is about 975 and 43,000 RUB, respectively. The introduction of methods that make it possible to predict the development and potential outcomes of adverse drug reactions, as well as taking into account the experiences of foreign colleagues in their modeling, will reduce economic costs in the Russian Federation at the federal level.Conclusion: for the economic value analysis and further forecasting, an improvement of existing methodologies is required. The models used in the Russian Federation (“the decision tree”, classification of diseases by clinical groups, Markov model) do not take into account the time factor, therefore, when planning the analysis of potential costs for adverse reactions, it is necessary to reinforce the methods with such tools as QALY, YLL, and YLD.

Analysis of Docetaxel Adverse Drug Reactions: A Retrospective Study Based on Iraqi Pharmacovigilance Center Database

Docetaxel is an effective treatment approved for many types of cancers, but its effectiveness in clinical practice can be compromised by significant occurrence of adverse drug reactions. The aim of the current study was to measure the distribution of adverse drug reactions of docetaxel reported in Iraq and to assess the causality, severity, seriousness, preventability, expectedness and outcome of these adverse reactions. A retrospective study conducted on individual case safety reports from the Iraqi Pharmacovigilance Center / Ministry of Health. The study included 118 individual case safety report containing 236 adverse drug reactions.Most of the adverse drug reactions were related to skin and subcutaneous tissue disorders(26.7%), followed by respiratory, thoracic and mediastinal disorders (20.8%), gastrointestinal disorders (17.4%) and general disorders and administration site conditions (10.6%). The majority of these reactions with possible causality (68.6%), moderate severity (75.4%), expected (80.5%), possibly preventable (93.2%), and serious (80.5%). In addition the most common outcome of adverse drug reactions was recovered / resolved (46.19%).

An investigation into the avoidability of adverse drug reactions using the LAAT and modified Hallas tools.

An adverse drug reactions avoidability tool called the Liverpool ADR avoidability assessment tool (LAAT) was recently developed (for research purposes), and subsequently validated with mixed interrater reliability (IRR). We investigated the comparative IRR of this tool in an inpatient cohort to ascertain its practical application in this setting.The patient population was comprised of 44 ADR drug pairs drawn from an observational prospective cohort of patents with ADR attending a Weill Cornell Medicine-affiliated tertiary medical Centre in Doha Qatar (Hamad General Hospital). Using the LAAT, and modified Hallas tools, 4 independent raters (2 Clinical Pharmacologists, and 2 General Physicians) assessed and scored the 44 ADR-drug pairs. Agreement proportions between the rating pairs were evaluated as well individual/overall kappa statistics and intraclass correlation coefficients. We evaluated the weight of each of the 7 questions on the LAAT tool to ascertain its determinative role.Across 44 ADR-drug pairs, the overall median Fleiss kappa using the LAAT, and modified Hallas tools were 0.67 (interquartile range (IQR) 0.55, 0.76), 0.36 (IQR, 0.23-0.71) respectively. The overall percentage pairwise agreement with the LAAT and modified Hallas tools were 78.5%, and 62.2% respectively. Exact pairwise agreement occurred in 37 out of 44 (range 0.71-1), and 27 of 44 (0.53-0.77) ADR-drug pairs using the LAAT and modified Hallas tools respectively. Using the LAAT tool, the overall intraclass correlation coefficient was 0.68 (CI 0.55, 0.79), and 0.37 (CI 0.22, 0.53) with the modified Hallas tool.We report a higher proportion of "possible" and "definite" avoidability outcomes of adverse drug reactions compared with the modified Hallas, or that reported by developers of the LAAT tool. Although initially developed for research purposes, our report has suggested for the first time a potential applicability of this tool in clinical environment as well.

Adverse Drug Reactions, Power, Harm Reduction, Regulation and the ADRe Profiles.

The power and influence of healthcare systems comes largely from the ability to prescribe efficacious medicine. However, medicine can sometimes cause harm rather than bring benefits. Systematically checking patients for the adverse effects of medicines, as listed in manufacturers’ literature, would protect patients from iatrogenic harm, but this is rarely undertaken. We argue for the benefits of this approach using the example of the prescription of antipsychotics to older adults. Prescribing antipsychotics to control challenging behaviours associated with dementia is a controversial matter, and regulatory intervention is under discussion. Improved regulatory systems could protect against iatrogenic harm, such as over-sedation, falls, tremor, or drug-induced Parkinsonism. However, measuring the impact and outcomes of regulatory interventions has proved difficult, not least because there are rarely systematic records of all adverse effects of medicines. We indicate how regulatory initiatives to reduce antipsychotic prescribing can be supported by systematic monitoring and documentation of patients’ signs and symptoms of putative adverse drug reactions. Monitoring documentation then provides the rationale and support for professionals’ responses to identified problems. Longitudinal monitoring records would improve understanding of the impact and outcomes of adverse drug reactions (ADRs) on health and wellbeing, and the many costs of ADRs.

Adverse drug reactions of oral dexamethasone in children and adolescents with childhood acute lymphoblastic leukemia: a systematic review.

To summarise and review the best available evidence on the poorer outcome of adverse drug reactions (ADRs) induced by oral dexamethasone in adolescents with Acute Lymphoblastic Leukaemia (ALL) than in children with ALL. Five databases for published literature were searched for the period 1990 to 2009. Additionally, the reference lists of all retrieved articles were further searched for additional references. Assessment for methodological quality was undertaken using a critical appraisal tool from JBI-SUMARI. Following the critical appraisal, data extraction was carried out using the data extraction tool from JBI-MAStaRI. Specific details about the study, design, data collection methods, participants, stage of therapy, type of adverse drug reaction, location of evidence and findings were then described and compiled into a table. Data synthesis was presented in a narrative format as the methodologically heterogeneous nature of the quantitative studies made it not appropriate to perform meta-analysis. Eleven included studies, mostly descriptive, formed the basis of this systematic review. The ADRs induced by oral dexamethasone that have a poorer outlook in adolescents with ALL than in children with ALL are: transient hyperglycemia, infectious complications, thrombosis, thromboembolism and avascular necrosis. Adolescents were observed to have higher incidence and risk to these ADRs. In some included studies, adolescence age was found to be a predictor of the ADRs. The results indicated that adolescents experience more severe ADRs induced by oral dexamethasone during ALL treatment than children. This phenomenon may be explained by the age-related variability in pharmacokinetics characteristics of dexamethasone between the adolescents and younger children as well as the impact of pubertal changes that occur in adolescents. The outcome of the ADRs however, may be inevitably affected by the presence of confounders such as co-administered drugs as well. The findings call for more attention to be given to ALL patients who are diagnosed at an adolescent age, especially when dexamethasone is administered. This will alert the healthcare professionals to watch for the ADRs when administering the treatment. Healthcare professionals should also inform caregivers and patients so that they can be more aware of the ADRs. Prospective studies involving a larger number of subjects should be carried out, with a focus on revising protocol's efficiency in monitoring dexamethasone-induced ADRs in ALL patients. Patient subgroups who are more vulnerable to such ADRs and often ignored in non-specific protocols should be identified and prophylactic interventions, such as early screening, proposed.

Risk factors, management and outcomes of adverse drug reactions in adult patients on antiretrovirals at Kenyatta National Hospital, Nairobi

Antiretrovirals have been associated with serious adverse drug reactions. Several factors have been suggested as independent risk factors for their development. Identification of these factors may help in prevention and management of the adverse drug reactions. To describe the factors associated with adverse drug reactions, their management, and the clinical outcomes. A retrospective cohort study. Kenyatta National Hospital, Comprehensive Care Centre. Adult patients receiving antiretrovirals from 2003 to 2006. The primary outcomes were the risk-factors, interventions and outcomes of documented adverse drug reaction after exposure to antiretrovirals. Systematic random sampling was used to pick 350 patients' files. The risk factors for experiencing at least one adverse drug reaction were: having a baseline CD4 count less than 123 (odds ratio [OR] = 1.82, 95% confidence interval [CI: 1.18 to 2.79; p = 0.006); treatment with antiretrovirals for more than 32 months (OR = 1.76, CI: 1.15 to 2.71; p = 0.010), using didanosine containing regimens (OR = 3.7, CI: 1.40 to 9.70; p = 0.008) or being on stavudine containing regimens (OR = 4.4, CI: 2.53 to 7.71; p = 0.001). The most common intervention was addition of a non-antiretroviral while 41% of events resulted in a change of anti-retroviral therapy. Current standard regimens in resource-limited countries are associated with an increased risk of adverse drug reactions. Almost half of adverse reactions are managed by addition of a non-anti-retroviral drug alone but 41% necessitated a change of anti-retrovirals.