Evaluation Of Adverse Drug Reactions Research Articles

Exploration and Evaluation of Adverse Drug Reactions Documented in a Tertiary-Care Hospital in Chennai: An In-Depth Retrospective Observational Study

Exploration and Evaluation of Adverse Drug Reactions Documented in a Tertiary-Care Hospital in Chennai: An In-Depth Retrospective Observational Study

Evaluation of adverse drug reactions to off-label use of drugs in children from spontaneously reported cases at a tertiary care hospital

Background: Off-label use of drugs (OLUDs) is relatively common in pediatric and this may be associated with adverse drug reactions (ADRs). The studies about the safety of drugs used in children cannot be applied to safety of drugs during OLUDs as drug is used in way that is different from that described in regulatory body. Hence, it is worthwhile to evaluate the off-label status of the suspected drugs causing ADRs. Aims and Objectives: The aim of the study was to analyze the pattern of ADRs occurring during OLUDs in pediatric patients from the spontaneously reported ADRs cases at the pharmacovigilance unit of a tertiary care hospital. Materials and Methods: Single center, retrospective, observational study was conducted in the department of pharmacology. ADRs spontaneously reported from January 2016 to December 2017, which occurred during OLUDs in children, where causality is certain, probable and possible. Results: A total of 46 ADRs occurred during OLUDs in 44 patients, these patients received 174 medicines among which 66 were off-labeled drugs. Off-label drugs mainly belonged to anti-infectives for systemic use (70.31%) and it is associated with 30 ADRs (68.18%). The most commonly affected organ system is skin and subcutaneous tissue (43.18%). Conclusion: OLUDs is associated with ADR, so caution should be taken while prescribing a drug in off-label manner in children.

Evaluation of Adverse Drug Reactions Induced by Cardiovascular Medications in Outpatient’s Clinics: A Cross Sectional Study

Evaluation of Adverse Drug Reactions Induced by Cardiovascular Medications in Outpatient’s Clinics: A Cross Sectional Study

EPH95 Evaluation of Adverse Drug Reactions and Quality of Life of HIV Patients Assessing Care at Public Secondary Hospitals in Ilorin, Nigeria

Adverse drug reactions (ADRs) linked to antiretroviral therapy (ART) can outweigh their benefits thereby compromising patients’ quality of life (QoL). This study evaluated ADRs and QoL of HIV patients assessing care at public secondary hospitals in Ilorin, Nigeria.

An evaluation of adverse drug reactions and outcomes attributed to kratom in the US Food and Drug Administration Adverse Event Reporting System from January 2004 through September 2021.

Kratom is a widely used Asian botanical that has gained popularity in the United States due to a perception that it can treat pain, anxiety, and opioid withdrawal symptoms. The American Kratom Association estimates 10-16 million people use kratom. Kratom-associated adverse drug reactions (ADRs) continue to be reported and raise concerns about the safety profile of kratom. However, studies are lacking that describe the overall pattern of kratom-associated adverse events and quantify the association between kratom and adverse events. ADRs reported to the US Food and Drug Administration Adverse Event Reporting System from January 2004 through September 2021 were used to address these knowledge gaps. Descriptive analysis was conducted to analyze kratom-related adverse reactions. Conservative pharmacovigilance signals based on observed-to-expected ratios with shrinkage were estimated by comparing kratom to all other natural products and drugs. Based on 489 deduplicated kratom-related ADR reports, users were young (mean age 35.5 years), and more often male (67.5%) than female patients (23.5%). Cases were predominantly reported since 2018 (94.2%). Fifty-two disproportionate reporting signals in 17 system-organ-class categories were generated. The observed/reported number of kratom-related accidental death reports was 63-fold greater than expected. There were eight strong signals related to addiction or drug withdrawal. An excess proportion of ADR reports were about kratom-related drug complaints, toxicity to various agents, and seizures. Although further research is needed to assess the safety of kratom, clinicians and consumers should be aware that real-world evidence points to potential safety threats.

Evaluation of Adverse Drug Reaction Caused by Concomitant Use of Trimethoprim-Sulfamethoxazole and Methotrexate in Pediatric Acute Lymphoblastic Leukemia Patients

Evaluation of Adverse Drug Reaction Caused by Concomitant Use of Trimethoprim-Sulfamethoxazole and Methotrexate in Pediatric Acute Lymphoblastic Leukemia Patients

Linking Activity Theory Within User-Centered Design: Novel Framework to Inform Design and Evaluation of Adverse Drug Reaction Reporting Systems in Pharmacy.

Adverse drug reactions (ADRs) may cause serious injuries including death. Timely reporting of ADRs may play a significant role in patient safety; however, underreporting exists. Enhancing the electronic communication of ADR information to regulators and between health care providers has the potential to reduce recurrent ADRs and improve patient safety. The main objectives were to explore the low rate of ADR reporting by community pharmacists (CPs) in Australia, evaluate the usability of an existing reporting system, and how this knowledge may influence the design of subsequent electronic ADR reporting systems. The study was carried out in 2 stages. Stage 1 involved qualitative semistructured interviews to identify CPs' perceived barriers and facilitators to ADR reporting. Data were analyzed by thematic analysis, and identified themes were subsequently aligned to the task-technology fit (TTF) framework. The second stage involved a usability evaluation of a commercial web-based ADR reporting system. A structured interview protocol that combined virtual observation, think-aloud moderating techniques, retrospective questioning of the overall user experience, and a System Usability Scale (SUS). The field notes from the interviews were subjected to thematic analysis. In total, 12 CPs were interviewed in stage 1, and 7 CPs participated in stage 2. The interview findings show that CPs are willing to report ADRs but face barriers from environmental, organizational, and IT infrastructures. Increasing ADR awareness, improving workplace practices, and implementing user-focused electronic reporting systems were seen as facilitators of ADR reporting. User testing of an existing system resulted in above average usability (SUS 68.57); however, functional and user interpretation issues were identified. Design elements such as a drop-down menu, free-text entry, checkbox, and prefilled data fields were perceived to be extremely useful for navigating the system and facilitating ADR reporting. Existing reporting systems are not suited to report ADRs, or adapted to workflow, and are rarely used by CPs. Our study uncovered important contextual information for the design of future ADR reporting interventions. Based on our study, a multifaceted, theory-guided, user-centered, and best practice approach to design, implementation, and evaluation may be critical for the successful adoption of ADR reporting electronic interventions and patient safety. Future studies are needed to evaluate the effectiveness of theory-driven frameworks used in the design and implementation of ADR reporting systems.

An evaluation of adverse drug reactions of Bakuchi containing formulations used in the management of Shvitra (vitiligo): A retrospective, observational record-based study

An evaluation of adverse drug reactions of Bakuchi containing formulations used in the management of Shvitra (vitiligo): A retrospective, observational record-based study

Evaluation of adverse drug reactions of chemotherapeutic agents used in advanced non-small cell lung cancer - experience from a rural tertiary care institution in North Eastern India.

Lung cancer is one of the major causes of morbidity and mortality both in developed and developing countries. Adverse drug reactions (ADRs) are inevitable, albeit unwanted aspects of cancer chemotherapeutic agents used in lung cancer. To determine common ADRs and the severity of ADRs of different chemotherapeutic agents used in non-small cell lung cancer (NSCLC) patients. The study was conducted among purposively selected 160 patients who had undergone chemotherapy for lung carcinoma. Clinical records of NSCLC patients were reviewed and data related to the socio-demographic and clinic-therapeutic profiles of patients were collected. ADRs were graded according to the Common toxicity criteria (CTC) grading. Data analysis was done using the IBM-SPSS software and presented using the principle of descriptive statistics. Relationships between ADRs and drug regimens were determined using Chi-square tests considering a 95% confidence interval and P value ≤ 0.05 as significant. Among 160 patients, 78.8% were males and 21.3% were females. The mean age was 59.15 ± 10.6 years, illness duration was 7.5 ± 10.6 months, and treatment duration was 4.4 ± 0.91 months. The overall mortality rate and systemic toxicity of the paclitaxel-carboplatin combination were the lowest. Almost an equal proportion of moderate to severe changes in parameters such as myelosuppression, anemia, thrombocytopenia, alopecia, skin changes, allergic reaction, and peripheral neuropathy, were observed with all chemotherapeutic regimens. Gemcitabine-carboplatin regimen was associated with a higher proportion of altered liver enzymes, electrolyte imbalance, diarrhea, pleural effusion, and renal toxicities. There was a high prevalence of ADRs with different chemotherapeutic agents. Early detection of these ADRs may help in minimizing the damage by either modifying the dose or changing the offending agent.

Evaluation of Adverse Drug Reactions Due to Fixed-dose Combinations at a Tertiary Care Hospital: An Observational Retrospective Study

Introduction: The mushrooming of Fixed-dose Combinations (FDCs) has been observed in the past decade in the Indian market. The majority of these FDCs are irrational and put patient safety at risk. Aim: To evaluate Adverse Drug Reactions (ADRs) due to rational as well as irrational FDCs available in India. Materials and Methods: This was an observational, retrospective study where recorded data of ADRs reported over a period of 10 years (January 2011-December 2021) at the Regional Training Centre and ADR Monitoring Centre (B.J. Medical College and Civil Hospital, Ahmedabad, Gujarat, India) was analysed. The data evaluation was carried out from May 1, 2022, to December 15, 2022. Any ADR where FDC(s) was the suspected causal drug was included in the analysis. Out of a total of 8,218 reported ADRs in the ten-year duration, 1,575 ADRs were reported to have occurred due to FDCs. The data were analysed for age, gender, System Organ Class (SOC), suspected drug, seriousness of the ADRs, causality assessment, and outcome of ADRs, and presented in terms of numbers or percentages. Results: A total of 1,575 ADRs occurred due to 1,649 FDC(s). The most common SOC class of ADRs was Gastrointestinal (GI) disorders in 359 (23%) cases, followed by skin and subcutaneous disorders in 317 (20%). The common suspected groups were Anti-Retroviral (ARV) drugs in 787 (50%) ADRs, followed by antitubercular drugs in 298 (19%). Out of a total of 1,649 FDCs as the suspected drug, 1,551 (94%) were rational, and 98 (6%) were irrational. A total of 169 (11%) serious ADRs were reported, of which seven ADRs were due to irrational FDCs (prescribed for cold and cough). Causality assessment using the World Health Organisation-Upsala Monitoring Centre (WHO UMC) classification showed a possible causal association with the suspect FDCs for 1,385 (84%) ADRs. Conclusion: FDCs contribute to a significant proportion of ADRs, which could be prevented by avoiding the use of irrational FDCs and monitoring the patients for the possible development of ADRs.

Pharmacists' role in detection and evaluation of adverse drug reactions: Developing proactive systems for pharmacosurveillance.

To identify current challenges in detection of medication-related symptoms, and review technology-based opportunities to increase the patient-centeredness of postmarketing pharmacosurveillance to promote more accountable, safer, patient-friendly, and equitable medication prescribing. Pharmacists have an important role to play in detection and evaluation of adverse drug reactions (ADRs). The pharmacist's role in medication management should extend beyond simply dispensing drugs, and this article delineates the rationale and proactive approaches for pharmacist detection and assessment of ADRs. We describe a stepwise approach for assessment, best practices, and lessons learned from a pharmacist-led randomized trial, the CEDAR (Calling for Detection of Adverse Drug Reactions) project. Health systems need to be redesigned to more fully utilize health information technologies and pharmacists in detecting and responding to ADRs.

AN EVALUATION OF ADVERSE DRUG REACTIONS WITH REMDESIVIR IN PATIENTS OF COVID-19

Objectives: The aim of the study was to evaluate the adverse drug reactions (ADR) following Remdesivir therapy in patients of COVID-19. Methods: All patients more than 18 years of age of any gender, diagnosed with COVID-19 infection receiving remdesivir therapy and fulfilling the selection criteria were included in the study after informed consent. They were monitored for ADRs till end of treatment and analyzed for characteristics of the ADRs: Causality, severity, and preventability. Results: Out of 80 patients (mean age of 49.27±16.22 years) enrolled, 51 (63.75%) developed 84 ADRs. Most common ADRs included increased aspartate transaminases, (20.23%), increased bilirubin (19.04%), increased alanine transaminases (13.09%), increased creatinine (11.90%), and increased blood urea (9.52%). Causality assessment using WHO-UMC scale showed, 85.71% possible, 13.09% probable, and 1% certain causal association of the ADRs with remdesivir. A total 75% ADRs were mild in severity and 45% patients recovered from the event at the end of treatment. Conclusion: Hepatic and Renal dysfunctions are observed with remdesivir in COVID-19 patients. Intensive monitoring of ADRs with newer drugs with EUA such as remdesivir is warranted to ensure safer use in patients.

Epidemiology and evaluation of adverse drug reactions in a Korean hospital database for spontaneous reports in the period 2009 to 2018.

To evaluate the epidemiology of adverse drug reactions (ADRs) in the Korean population and to identify their characteristics and factors affecting their severity. The analysis was based on the ADRs reported to the Seoul National University Hospital between 2009 and 2018. Statistical assessment (SPSS Statistics 25) included frequency analysis and the χ2-test. Risk factors were assessed using logistic regression analysis. Results were considered significant at p< 0.05. A total of 44,122 cases were analyzed of which 24,801 (56.2%) cases concerned females and 19,321 (43.8%) males. A total of 47% of cases involved persons aged between 50and79 years. Antineoplastic agents, immunomodulating agents, and systemically administered anti-infective agents accounted for 57.6% of all drugs reported. Gastro-intestinal system disorders accounted for the largest proportion (25.8%) of adverse drug reactions reported. A total of 3,429 (7.8%) ADRs were reported as being in the category severe. Multivariate analysis showed that the risk of an ADR being reported as severe is higher in males than in females (OR=1.25, 95% CI: 1.16-1.35), and higher in those aged 0-4 years (OR=1.74, 95% CI: 1.46-2.08), in those aged 5-19 years (OR=1.19, 95% CI: 1.07-1.31), and in those aged 65 years and over (OR=1.26, 95% CI: 1.16-1.37), compared to those aged 20-64 years. From a public health perspective, ADRs are important because they are preventable. Important determinants, such as differences in specific age groups and drug classes, for the occurrence of ADRs and the occurrence of severe ADRs in particular, were identified. These determinants need to be carefully monitored in both private medical practices, clinics and hospitals. This monitoring of specific groups will involve close attention factors associated with gender, age group, and drug classes.

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.

Effect of Irbesartan on Elderly Hypertensive Patients in Community and Evaluation of Adverse Drug Reactions

Effect of Irbesartan on Elderly Hypertensive Patients in Community and Evaluation of Adverse Drug Reactions

Evaluation of adverse drug reaction in patients warfarin therapy.

This research aimed to understand the adverse drug reaction (ADR) in heart disease outpatients who were administered warfarin at a hospital in Bandung city. The research was conducted using a cross-sectional design with an observational approach. Subsequently, data were collected from 74 patients who met the inclusion criteria. The causality assessment was made by the Naranjo Algorithm and the incidence of bleeding was classified based on the Bleedscore™. The result showed that the most common ADR were nausea, dizziness, stomach ache, ecchymosis, petechiae, bleeding in the mouth, melena, etc. Furthermore, the INR value was the most significant factor in the incidence of ADR. It was 6.445 using a value of P = 0.001 or a confidence interval of 95%. The most common side effect of warfarin in cardiac outpatients was superficial bleeding, followed by internal bleeding (melena). The INR value is the most significant factor in measuring the incidence of ADR.

Evaluation of adverse drug reactions in patients of schizophrenia in tertiary care teaching hospitals in Central India

Background: For decades, it has been observed that mental health is shrouded in stigma and discrimination. The scope, severity, and expense of impairment and costs to people, families, and societies are staggering. Mental illnesses are among the most frequent illnesses, affecting over a quarter of the population in any given year. According to national institute of mental health and neurosciences, Bangalore, the prevalence of schizophrenia has been considered as 4/1000 for all ages and both sexes. Aim and Objectives: The objectives of this study were to as follows: (1) To evaluate adverse drug reactions (ADRs) in patients with schizophrenia who received antipsychotic treatment and (2) to compare ADRs in typical versus atypical antipsychotic agents in schizophrenic patients. Materials and Methods: A total of 50 schizophrenic patients were enrolled for evaluating adverse effects to antipsychotic drugs. During the research, all ethical precautions were taken. All patients were followed up by medical history, history of drugs, and any severity of adverse drug reaction. Causality assessment was graded by Naranjo scale. Result: Among all of the antipsychotic drugs, risperidone (05%), quetiapine (04%), and aripiprazole (04%) have shown lowest propensity to cause serious adverse event. These drugs are most commonly prescribed drugs and are least likely to affect quality of life of patient. However, the risk of extrapyramidal symptoms is lower with olanzapine (05%) than haloperidol (34%) and even in case with risperidone at higher dose (20%). Although atypical antipsychotics such as olanzapine (46%) have shown maximum potential to produce metabolic side effect such as dyslipidemia and hyperglycemia compared to that of other antipsychotics. Conclusion: The most common adverse effects were found with typical and atypical antipsychotics such as weight gain, drowsiness, constipation, sedation, dyslipidemia, and hypotension.

Evaluation of adverse drug reactions in patients with Type II diabetes mellitus in tertiary care hospitals, Bhopal

Evaluation of adverse drug reactions in patients with Type II diabetes mellitus in tertiary care hospitals, Bhopal

Evaluation of Adverse Drug Reactions in Paediatric Patients: A Retrospective Study in Turkish Hospital.

Drug safety in paediatric patients is a serious public health concern around the world. The paediatric patients are more prone to adverse drug reactions (ADRs) than adults. Moreover, there is a scarcity of information about ADRs in paediatric patients. This study was conducted to determine the frequency, causality, severity, preventability of paediatric patients’ ADRs reported in a tertiary care hospital in Adana, Turkey. A retrospective study was conducted on all spontaneously reported ADRs between January 01, 2020, to July 30, 2021, in paediatric patients. The ADRs reports were evaluated in terms of gender, age, ADR characteristics, suspected drugs and reporting source. All included ADRs reports were characterized according to the Naranjo Algorithm/World Health Organization (WHO) causality scales, Hartwig/Siegel and Common Terminology Criteria for Adverse Events (CTCAE) severity scales, the modified Schoumock and Thornton preventability scale and hospital pharmacovigilance center criteria for seriousness. Therapeutic groups were also coded using the WHO-Anatomical Therapeutic and Chemical (ATC) classification. During the study period, 8,912 paediatric patients who were admitted had 16 ADRs with 1.7 ADRs/1,000 admissions. The majority of ADRs were found in infants (31.2%) and children (56.2%) as compared to adolescents (12.5%). ADRs were observed more in females (81.2%) than males. Skin (62.5%) was the most affected organ due to the ADRs, and maculopapular rash and erythema multiforme were the most commonly reported symptoms. Most ADRs were probable/likely (93.7%), severe (50%), preventable or probably preventable (43.7%) and serious (37.5%). Antibiotics (93.7%) were found to be the most common cause of ADRs in paediatric patients. The majority of ADRs were associated with vancomycin (68.7%). Most of the ADRs were reported by a medical doctor in this study. This small sample size study highlights significant problems of ADRs in paediatric patients, mainly caused by antibiotics and with a majority of ADRs manifest as skin reactions. Furthermore, a high proportion of the identified ADRs were found to be preventable. More focused efforts are needed at the national level to avoid preventable ADRs in hospitals. Monitoring and management of ADRs and future studies would be beneficial for better patient care and safety.

Safety and efficacy of Tolvaptan in real-world patients with autosomal dominant polycystic kidney disease- interim results of SLOW-PKD surveillance

BackgroundTolvaptan is a vasopressin type 2 receptor antagonist and has been used to treat autosomal dominant polycystic kidney disease (ADPKD) since 2014. There has been limited real-world data on the safety and efficacy of tolvaptan.MethodsThis post-marketing surveillance was conducted to evaluate the long-term safety and the efficacy of tolvaptan in Japanese patients with ADPKD in real-world clinical settings. The baseline characteristics of 1630 patients treated with tolvaptan are reported. Safety analysis comprises evaluation of adverse drug reactions (ADRs). The efficacy evaluation includes percent change in total kidney volume (TKV) and change in estimated glomerular filtration rate (eGFR) before and after tolvaptan treatment.ResultsMean age was 49.7 ± 11.2 years and 843 (51.7%) patients were male. Baseline TKV was 2158 ± 1346 mL and eGFR was 44.4 ± 21.7 mL/min/1.73 m2. The majority of CKD patients were stage G3b (27.0%) and G4 (30.1%). Frequently reported ADRs were hepatic function abnormal (8.3%), thirst (8.2%), and hyperuricaemia (6.9%). The frequency of ALT elevation (> 30 and > 90 IU/L) was slightly high (32.9 and 8.3%) to previous studies. After tolvaptan treatment, the annual rate of percentage change in TKV reduced from 11.68%/year to 2.73%/year (P < 0.0001). Similar results were also obtained for the effect on change in eGFR from − 3.31 to − 2.28 mL/min/1.73 m2/year after initiation of tolvaptan treatment (P = 0.0403).ConclusionThere were no major problems with safety of tolvaptan treatment and comparable efficacy for TKV and eGFR was observed in relation to the previous pivotal two randomized control trials in this post-marketing surveillance.