Types Of Adverse Drug Reactions Research Articles

Predictors of Adverse Drug Reaction-Related Hospitalisations Among People with Dementia: A Retrospective Case-Control Study.

Adverse drug reactions (ADRs) are common among people with dementia; however, little is known about the magnitude and predictors associated with ADR-related hospitalisation among these individuals. This study aimed to determine the magnitude, types, drugs implicated and predictors of ADRs associated with hospitalisation among people with dementia. This retrospective case-control study analysed medical records of individuals aged ≥ 65 years with dementia admitted to major public hospitals in Tasmania, Australia, from July 2010 to July 2021. Adverse drug reactions and implicated drugs were identified using administrative data and cross-checked with hospital medical records, with consensus reached among the research team. Of the 7928 people admitted to hospital at least once within the study period, 1876 (23.7%) experienced at least one ADR-related hospitalisation. Of these, 300 case patients with 311 ADRs and 300 control patients were randomly selected. The most common types of ADRs were renal (acute kidney injury; AKI) (36.0%), followed by neuropsychiatric (17.6%), cardiovascular (16.0%) and haematological (13.1%). Diuretics, renin-angiotensin system (RAS) inhibitors and anti-thrombotics constituted the main implicated drug classes. The ADR-related hospitalisation was associated with: chronic kidney disease (CKD) (OR 8.00, 95% CI 2.63-24.28, p < 0.001), Australian-born (OR 1.62, 95% CI 1.08-2.43, p = 0.019), hypertension (OR 1.48, 95% CI 1.01-2.17, p = 0.044) and the number of medicines (OR 1.06, 95% CI 1.00-1.12, p = 0.022). Potentially inappropriate medication use and anticholinergic burden did not predict ADR-related hospitalisation. These predictors could help identify the individuals at the highest risk and enable targeted interventions to be designed.

Physicians’ awareness and use of drug-drug interactions software: A preliminary study

Background: Drug-drug interactions software is used as a tool to investigate clinically harmful interactions. Prescribers need to be aware of these tools to improve the quality of drug prescriptions, thus ensuring better patient care. Drug-drug interactions are a common avoidable type of adverse drug reactions, which can have detrimental effects on patients in the form of drug toxicity Objective: To determine the awareness of prescribers and the use of drug-drug interaction software. Method: The awareness of physicians of drug interaction software was assessed. A self-administered questionnaire was administered to all resident physicians in the Department of Internal Medicine, University of Benin Teaching Hospital to assess their awareness and use of the drug-drug interaction software. The information sought includes sociodemographic characteristics, Physician’s awareness, and use of drug interaction software. The results are presented descriptively. Results: Thirty-four medical residents filled out the self-administered questionnaire. The number of physicians aware of drug-drug interactions software was 30 (82.2%) for Medscape, Drugs.com 21 (61.8%), Lexi-interact 4(11.8%), and 3 (8.8%) for Epocrates. Medscape interaction checker was most used by 26 (76.5%) while Micromedex was least used by one (2.9%) medical resident. Conclusion: Physicians were largely aware of and used Medscape.

Advancing Adverse Drug Reaction Prediction with Deep Chemical Language Model for Drug Safety Evaluation.

The accurate prediction of adverse drug reactions (ADRs) is essential for comprehensive drug safety evaluation. Pre-trained deep chemical language models have emerged as powerful tools capable of automatically learning molecular structural features from large-scale datasets, showing promising capabilities for the downstream prediction of molecular properties. However, the performance of pre-trained chemical language models in predicting ADRs, especially idiosyncratic ADRs induced by marketed drugs, remains largely unexplored. In this study, we propose MoLFormer-XL, a pre-trained model for encoding molecular features from canonical SMILES, in conjunction with a CNN-based model to predict drug-induced QT interval prolongation (DIQT), drug-induced teratogenicity (DIT), and drug-induced rhabdomyolysis (DIR). Our results demonstrate that the proposed model outperforms conventional models applied in previous studies for predicting DIQT, DIT, and DIR. Notably, an analysis of the learned linear attention maps highlights amines, alcohol, ethers, and aromatic halogen compounds as strongly associated with the three types of ADRs. These findings hold promise for enhancing drug discovery pipelines and reducing the drug attrition rate due to safety concerns.

Drug hypersensitivity reactions: review of the state of the science for prediction and diagnosis.

Drug hypersensitivity reactions (DHRs) are a type of adverse drug reaction that can occur with different classes of drugs and affect multiple organ systems and patient populations. DHRs can be classified as allergic or non-allergic based on the cellular mechanisms involved. Whereas non-allergic reactions rely mainly on the innate immune system, allergic reactions involve the generation of an adaptive immune response. Consequently, drug allergies are DHRs for which an immunological mechanism, with antibody and/or T cell, is demonstrated. Despite decades of research, methods to predict the potential for a new chemical entity to cause DHRs or to correctly attribute DHRs to a specific mechanism and a specific molecule are not well-established. This review will focus on allergic reactions induced by systemically administered low molecular weight (LMW) drugs with an emphasis on drug- and patient-specific factors that could influence the development of DHRs. Strategies for predicting and diagnosing DHRs, including potential tools based on the current state of the science, will also be discussed.

Impact of antiretroviral therapy on cutaneous adverse drug reactions in adult HIV patients: A study from a tertiary care hospital

Background: Adverse drug reactions (ADRs) significantly impact public healthcare, especially among HIV patients. These reactions, which range from mild pruritus to severe conditions such as Steven-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), affect the quality of life and treatment outcomes. Aims and Objectives: The current study was designed to evaluate the various types of cutaneous ADRs (CADRs) in adult HIV patients undergoing antiretroviral therapy (ART). Materials and Methods: A retrospective record-based study was conducted at the Department of Dermatology, Venereology, and Leprosy, Government Medical College/Government General Hospital, Suryapet, Telangana, India. Data from November 2017 to October 2020 were analyzed, focusing on patients over 18 years on ART. Relevant demographic and medical data, including blood tests, liver and renal function, and CD4 counts, were collected. Results: Out of 3532 patients on ART, 568 (16.08%) developed CADRs. Females represented 54.2% of these cases. The age group most affected was between 29 and 48 years. The most common ART regimen was Tenofovir+Lamivudin+Dolutegravir, followed by zidovudine-based combinations. Nevirapine-based regimens had a higher association with CADRs, particularly severe reactions such as SJS and TEN. Conclusion: A significant proportion of HIV patients on ART experience CADRs, with certain drug combinations posing higher risks. This study highlights the need for careful monitoring and selection of ART regimens to minimize the risk of severe CADRs, thereby improving patient outcomes and quality of life in HIV treatment.

Pattern of central nervous system related adverse drug reactions (ADRs) due to anti-retroviral therapy in HIV infected patients in tertiary care hospitals in North India

Background: Anti-retroviral therapy is associated with myriads of side-effects. Central nervous system related side effects are troublesome and mostly self limiting. Working knowledge of these side effects can improve the prescription habits of physicians. The study aimed pattern of central system related adverse drug reactions (ADRs) due to anti-retroviral therapy in HIV infected patients in tertiary care hospitals in North India. Materials and methods: A prospective observational study was conducted and all HIV positive patients, previously registered and new; attending OPD who encountered ADRs were enrolled in our study irrespective of their age and sex. Data was collected using ADR reporting form issued by Indian Pharmacopoeia Commission. Causality assessment was done by using Naranjo’s Probability Scale. Modified Hartwig severity scale was used to evaluate severity, WHO criteria for seriousness and guidelines of council for international organizations of medical sciences to decide the predictability of ADRs. Results: A total of 250 patients encountered various types of ADRs during the study period. Total number of ADRs recorded was 452. Out of total ADRs (n=452) recorded, 20.35% (n=92) were central system related ADRs. Most common central nervous system related ADR was dizziness. Most central nervous system related ADRs were of moderate type and possible in nature on causality assessment. Conclusion: Relatively overweight, older age and baseline CD4 absolute count below 250 cells/mm3, were predictors for central nervous system related side effects due to anti-retroviral therapy in HIV patients. We suggest that more stringent evaluation and monitoring should be carefully done in all HIV/AIDS patients who will receive and on efavirenz based anti-retroviral therapy, especially if they have the above predictors.

Fixed drug eruption-induced balanoposthitis: a case report.

Fixed Drug Eruptions (FDE) represent a distinctive type of adverse drug reaction, typically characterized by recurring, sharply demarcated skin lesions occurring at identical sites with each administration of the causative drug. A less frequent, albeit significant manifestation of FDE, is balanoposthitis, an inflammatory condition affecting the glans penis and prepuce. This rare case report explores the clinical presentation, diagnosis, and therapeutic management of FDE-induced balanoposthitis in a 34-year-old male patient who developed this condition following azithromycin administration to treat a pulmonary infection. The patient's distinctive symptoms, coupled with a medical history of similar antibiotic-induced reactions, pointed strongly towards an FDE diagnosis. Management entailed immediate discontinuation of the offending drug and initiation of symptomatic treatment, culminating in a positive therapeutic outcome. This case illuminates the potential of commonly prescribed medications, such as antibiotics, to incite balanoposthitis via FDE. It underscores the critical need for healthcare professionals to include FDE in their differential diagnosis for balanoposthitis, especially when patient exposure to high-risk medications is evident. Furthermore, the report emphasizes the pressing requirement for additional research to elucidate the pathogenesis of FDE-induced balanoposthitis and to devise effective therapeutic and preventive measures.

Diabetes mellitus increases risk of adverse drug reactions and death in hospitalised older people: the SENATOR trial.

Adverse drug reactions (ADRs) are a major cause of morbidity and mortality, especially in older people. Older people with diabetes mellitus may be at especially high risk of ADRs but this risk has not been well studied. This study aimed to compare severity and type of ADRs in hospitalised, multimorbid older people with and without diabetes and secondly to assess the impact of ADRs on mortality, rehospitalisation and length of stay. Participants in the SENATOR (Software Engine for the Assessment and optimization of drug and non-drug Therapy in Older peRsons) trial were assessed for 12 common and 'other' prevalent and incident adverse drug reactions using a blinded end-point adjudication process. Descriptive analyses, logistic regression and mediation analyses were undertaken. Of 1537 people in the SENATOR trial, 540 (35.1%) had diabetes mellitus (mean age 77.4 ± 7.3years, 58.5% male). In the total population, 773 prevalent and 828 incident ADRs were reported. Both prevalent and incident symptomatic hypoglycaemia and incident acute kidney injury (AKI) were significantly more common in people with diabetes (p < 0.05). Patients with diabetes had higher all-cause mortality at 12weeks than those without (9.1% vs 6.3%, p = 0.04). Mediation analysis revealed that mortality was significantly higher (OR = 1.43, Sobel test p = 0.048) in people with diabetes and ADRs causing AKI. Older multimorbid people with diabetes presenting to hospital with acute illness have significantly more ADRs than those without, and a significantly higher mortality that is mediated by medication-associated AKI and poorer renal function.

Safety of subcutaneous and sublingual immunotherapy with allergoids in children: a real-life pharmacovigilance study.

Aims: Allergen-specific immunotherapy uses a sublingual (sublingual immunotherapy [SLIT]) or subcutaneous (subcutaneous immunotherapy [SCIT]) route. This pharmacovigilance study aimed to determine the number and type of adverse drug reactions (ADRs) for SLIT and SCIT using carbamylated monomeric allergoids (CMAs) in children. Materials & methods: This pharmacovigilance study analyzed real-world post-marketing reports collected from a safety database of Lais sublingual tablets and injective Lais-in, containing CMAs for over 10 years. Results & conclusion: From January 2009 to September 2022, 26,107 doses of Lais-in were administered in children; only two nonserious related ADRs (incidence: 0.000077%) were reported. Regarding SLIT, the results showed only 12 spontaneous nonserious ADR reports (incidence: 0.000004%). These data showed the excellent safety profile of both SLIT and SCIT CMAs.

Safety profile of methotrexate used off-label in ectopic pregnancy: an active monitoring study based on a Chinese hospital pharmacovigilance system

Objective Methotrexate (MTX) is characterized as first-line therapy although its indication of ectopic pregnancy is off-label use. We aimed to conduct a retrospective cohort study to investigate the incidence, characteristics of adverse drug reactions (ADRs) of MTX, provide valuable insights for medical workers. Methods Basing on China Hospital Pharmacovigilance System (CHPS), a retrospective analysis was performed to evaluate the safety of MTX (n = 672). An active monitoring model was set to detect ADR signals from the hospital information system. Frequency, Common Terminology Criteria for Adverse Events (CTCAE) grade proportion and association of dose exposure with ADRs were presented as outcomes. Results The total incidence of ADRs was 54.0%. Anaemia (37.6%) was the most frequent ADR, followed by hepatic function abnormal (11.3%), hyperuricemia (6.1%), neutropenia (4.6%), leukopenia (4.0%), and dyslipidaemia (2.5%). For the composition of all ADRs, CTCAE grade one, two and three dominated for 86.3%, 12.1% and 1.6%, respectively. The severity of hepatic function abnormal was more serious in the two-dose exposed group (p = .021), while other types of ADRs had no statistical or clinical differences. Logistic regression analysis showed the incidence of any ADRs (OR 1.87 [1.31–2.64]; p = .001), hepatic function abnormal (OR 2.75 [1.69–4.48]; p < .001), dyslipidaemia (OR 5.15 [1.87–14.13]; p = .001) were significantly higher in the two-dose exposed group. After adjusted, the positive associations were still maintained. Conclusions MTX is quite safe in ectopic pregnancy, despite its mild to moderate hematotoxicity, hepatotoxicity and nephrotoxicity. Taking CHPS can present the accurate denominator of the incidence of adverse drug reactions into account, our study advocates that it may have great potential to be used as an active monitoring tool for off-label drug use risk management.

Cutaneous adverse drug reactions

Cutaneous adverse drug reactions (ADRs) represent a heterogeneous field including various clinical patterns without specific features suggesting drug causality. Maculopapular exanthema and urticaria are the most common types of cutaneous ADR. Serious cutaneous ADRs, which may cause permanent sequelae or have fatal outcome, may represent 2% of all cutaneous ADR and must be quickly identified to guide their management. These serious reactions include bullous manifestations (epidermal necrolysis i.e. Stevens-Johnson syndrome and toxic epidermal necrolysis), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP). Some risk factors for developing cutaneous ADRs have been identified, including immunosuppression, autoimmunity or genetic variants. All drugs can cause cutaneous ADRs, the most commonly implicated being antibiotics (especially aminopenicillins and sulfonamides), anticonvulsants, allopurinol, antineoplastic drugs, non-steroidal anti-inflammatory drugs and iodinated contrast media. Pathophysiology is related to immediate or delayed "idiosyncratic" immunologic mechanisms, i.e., usually not related to dose, and pharmacologic/toxic mechanisms, commonly dose-dependent and/or time-dependent. If an immuno-allergic mechanism is suspected, allergological explorations (including epicutaneous patch testing and/or intradermal test) are often possible to clarify drug causality, however these have a variable sensitivity according to the drug and to the ADR type. No in vivo or in vitro test can consistently confirm the drug causality. To determine the origin of a rash, a logical approach based on clinical characteristics, chronologic factors and elimination of differential diagnosis (especially infectious etiologies) is required, completed with a literature search. Reporting to pharmacovigilance system is therefore essential both to analyze drug causality at individual level, and to contribute to knowledge of the drug at population level, especially for serious cutaneous ADRs or in cases involving newly marketed drugs.

Prescribing cascades in ambulatory care: A structured synthesis of evidence.

The strength of evidence for specific ambulatory care prescribing cascades, in which a marker drug is used to treat an adverse event caused by an index drug, has not been well characterized. To perform a structured, systematic, and transparent review of the evidence supporting ambulatory care prescribing cascades. Ninety-four potential prescribing cascades identified through a previously published systematic review. Systematic search of the literature to further characterize prescribing cascades. (1) Grading of evidence based on observational studies investigating associations between index and marker drugs, including: Level I-strong evidence [i.e. multiple high-quality studies]; Level II-moderate evidence [i.e. single high-quality study]; Level III-fair evidence [no high-quality studies but one or more moderate-quality studies]; and Level IV-poor evidence [other]. (2) Listing of the adverse event associated with the index drug in the product's United States Food and Drug Administration (FDA) label. (3) Synthesis of the evidence supporting mechanisms linking index drugs and associated adverse events. Of 99 potential cascades, 94 were supported by one or more confirmatory observational studies and were therefore included in this review. The 94 cascades related to 30 types of adverse drug reactions affecting 10 different anatomic/physiologic systems and were investigated by a total of 88 confirmatory studies, including prescription sequential symmetry analysis (n = 51), cohort (n = 30), and case-control (n = 7) studies. Overall, the evidence from observational studies was strong for 18 (19.1%) prescribing cascades, moderate for 61 (64.9%), fair for 13 (13.8%), and poor for 2 (2.1%). Although the evidence supporting mechanisms that link index drugs and associated adverse events was variable, FDA labels included information about the adverse event associated with the index drug for most (n = 86) but not all of the 94 prescribing cascades. Although we identified 18 of 94 prescribing cascades supported by strong clinical evidence and most adverse events associated with index drugs are included in FDA label, the evidentiary basis for prescribing cascades varies, with many requiring further evidence of clinical relevance.

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.

Knowledge, Attitudes, and Practices of Adverse Drug Reaction Reporting Among Healthcare Professionals in Sri Lanka- A Cross Sectional Study.

Objectives: The objectives of this study were to describe the knowledge, attitudes and practices of Adverse Drug Reactions (ADR) reporting among healthcare professionals at Teaching Hospital Karapitiya (THK), a tertiary care hospital in Sri Lanka. Methodology: A descriptive cross-sectional study was conducted at THK. The healthcare professionals working in THK who were available during the study period were invited to the study. A self-administered pre-tested questionnaire was administered to the participants. Respondents were evaluated for their knowledge, attitudes and practices related to ADR reporting. The data were analyzed using SPSS statistical software. Results: Of the total 444 respondents, 31% were doctors and 69% were nurses. The majority of respondents, 90% (n = 400) were aware of the term ADR, while 64.8% (n = 288) could correctly define it. Among the respondents, 30.8% (n = 137) knew about the types of ADR and only 15.5% (n = 70) were able to mention a drug that is banned due to ADR correctly. Among the respondents, only 38.7% (n = 172) were aware of a formal process of reporting ADR and, only 35.3% (n = 157) stated that they had seen the ADR reporting form. Further, only 33.7% (n = 150) respondents have recognized ADR during their clinical practice and only a small proportion 18.2% (n = 81) have ever reported an ADR during their practice. Regarding attitudes toward ADR reporting, overall 84.1 (n = 373) had positive attitudes toward ADR reporting, while 13.54% (n = 60) of them stayed neutral and 2.25% (n = 10) had negative attitudes toward ADR reporting. Conclusions: Although the majority were aware of ADR , the knowledge and practices regarding spontaneous reporting of ADR are inadequate. However, most respondents have shown a positive attitude toward ADR reporting. A sincere and sustained effort should be made by concerned bodies to enhance the healthcare professionals' knowledge, attitudes, and practices regarding ADR reporting.

Association of adverse effects with high serum posaconazole concentrations.

Posaconazole therapeutic drug monitoring (TDM) is widely utilized to assess therapeutic efficacy and safety; however, clinical effects of very high serum concentrations are unknown. A retrospective review of 90 patients receiving posaconazole for treatment or prophylaxis of invasive fungal infections with serum concentrations ≥3000ng/mL from 1/1/2019 to 4/30/2021 evaluated the incidence and type of adverse drug reactions (ADRs). Symptomatic ADRs were very common in patients with posaconazole concentrations of ≥5000ng/mL and 3000-4999ng/mL (80% vs. 58.8%; P=0.31). Posaconazole TDM should be performed for both treatment and prophylaxis indications and dose decrease for serum concentrations >3000ng/mL should be considered.

Aripiprazole-Induced Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis: A Case Study.

The use of medications in management of disease is an integral part of treatment to patients in both the inpatient and outpatient setting; however, these medications often have risk of adverse effects associated with their benefits of use. Adverse cutaneous reactions are one of the most frequent types of adverse drug reactions. Two major phenotypes of cutaneous adverse drug reactions are toxic epidermal necrolysis (TEN), and Stevens-Johnson syndrome (SJS). Aripiprazole is an antipsychotic drug with a well-documented profile of adverse effects for physicians to be aware of; however, SJS/TEN is not known to be included in that profile. The authors encountered a case of aripiprazole-induced SJS/TEN and used the electronic medical records from this encounter to summarize this novel case in detail. Existing literature was reviewed using public databases for evaluation of similar cases. We present a case of SJS/TEN induced by aripiprazole use for bipolar disorder, type 1, which is not an adverse effect of the drug that has been documented in the literature. We include patient history, hospital course, images, and treatment of disease throughout admission as well as a thorough discussion of the topic. We present a case of an adverse drug reaction that has not previously been documented in the literature with the goal of informing readers of the potential for this life-threatening atypical effect and the severity of disease it may cause.

Drug-related problems among esophageal, gastric and colorectal cancer patients at the National and referral hospital in Kenya.

Cancer therapy has remarkable potential for drug-related problems due to the high cytotoxicity and narrow therapeutic index of most anti-neoplastic regimens. However, there is a lack of comprehensive studies on drug-related problems in patients with gastrointestinal cancer in Kenya. Therefore, the present study aimed to investigate the prevalence, types and predictors of drug-related problems among gastrointestinal cancer patients at Kenyatta National Hospital. A cross-sectional study was used to assess the prevalence of drug-related problems among a random sample of 160 esophageal, 103 gastric, and 96 colorectal cancer patients. Data were collected using a researcher-administered questionnaire and data abstraction tool after training the data collectors. Patient-specific details such as socio-demographic features, histological cancer types, cancer stage, comorbidity types, and treatment regimen were recorded after the review of medical records and patient interviews. The potential of drug-related problems was determined as per the standard guidelines. The data were entered and analysed using version 26.0 SPSS statistical software. Most esophageal (51.9%), gastric (59.2%), and colorectal (62.5%) cancer patients had a high prevalence of drug-related problems. The need for additional drug therapy and adverse drug reactions were the predominant categories of drug-related problems. Most adverse drug reactions identified had possible categories of causality score, mild severity levels, and definitely preventable types of adverse drug reactions among all gastrointestinal cancer patients. Comorbidity and advanced-stage disease were significant predictors of drug-related problems. Drug-related problems were prevalent among gastrointestinal cancer patients in our setting. Comorbidity and advanced stages of disease were significant predictors of drug-related problems.

Documented Adverse Drug Reactions and Discontinuation of Angiotensin-Converting Enzyme Inhibitors and Angiotensin Receptor Blockers in Chronic Kidney Disease

Introduction: Angiotensin-converting enzyme inhibitors (ACEis) and angiotensin receptor blockers (ARBs) are frequently discontinued in patients with chronic kidney disease (CKD). Documented adverse drug reactions (ADRs) in medical records may provide insight into the reasons for treatment discontinuation. Methods: In this retrospective cohort of US veterans from 2005 to 2019, we identified individuals with CKD and a current prescription for an ACEi or ARB (current user group) or a discontinued prescription within the preceding 5 years (discontinued group). Documented ADRs in structured datasets associated with an ACEi or ARB were categorized into 17 pre-specified groups. Logistic regression assessed associations of documented ADRs with treatment discontinuation. Results: There were 882,441 (73.0%) individuals in the current user group and 326,794 (27.0%) in the discontinued group. There were 26,434 documented ADRs, with at least one documented ADR in 7,520 (0.9%) current users and 9,569 (2.9%) of the discontinued group. ADR presence was associated with treatment discontinuation, aOR 4.16 (95% CI: 4.03, 4.29). The most common documented ADRs were cough (37.3%), angioedema (14.2%), and allergic reaction (10.4%). ADRs related to angioedema (aOR 3.81, 95% CI: 3.47, 4.17), hyperkalemia (aOR 2.03, 95% CI: 1.84, 2.24), peripheral edema (aOR 1.53, 95% CI: 1.33, 1.77), or acute kidney injury (aOR 1.32, 95% CI: 1.15, 1.51) were associated with treatment discontinuation. Conclusion: ADRs leading to drug discontinuation were infrequently documented. ADR types were differentially associated with treatment discontinuation. An understanding of which ADRs lead to treatment discontinuation provides an opportunity to address them at a healthcare system level.

TO ASSESS THE KNOWLEDGE, ATTITUDE, AND PRACTICE OF PHARMACOVIGILANCE AND ADVERSE DRUG REACTION REPORTING AMONG THE UNDERGRADUATE AND POSTGRADUATE MEDICAL STUDENTS IN A TERTIARY CARE TEACHING HOSPITAL IN ASSAM: A QUESTIONNAIRE-BASED STUDY

Objectives: Adverse drug reaction (ADR) is an important factor contributing to mortality and morbidity worldwide. Since undergraduate (UG) and postgraduate (PG) students are the future caregivers to the patients, they should have sound knowledge, a positive attitude, and good practice of Pharmacovigilance (PV). Hence this study was conducted to assess their knowledge, attitude, and practice (KAP) of PV and ADR reporting. Furthermore, secondarily this study tried to look into the impact of competency-based medical education (CBME) on the KAP of the students. Methods: Questionnaire-based, observational, and cross-sectional study. The questionnaire was pre-validated and consisted of 30 questions to assess the KAP of UG and PG medical students of a tertiary care teaching hospital in Assam. Results: A total of 419 students participated in the study. Data were analyzed using Microsoft Excel Sheet and the Student’s t-test. Both UGs and PGs have good knowledge about PV, ADR, and the types of ADRs to be reported. They also have a positive attitude but in practice, only a few have filled up the ADR form. Mean score analysis showed p-value was significant for attitude and practice among the UGs and PGs and highly significant for KAP when the CBME and Old Curriculum were compared. Conclusion: Although students have good knowledge and attitude, they need to improve in their practice. Regular training and awareness programs might help in educating them about PV and ADR reporting. However, the introduction of the CBME curriculum has been shown to improve the knowledge and attitude of the students about PV and ADR reporting.

Antibiotics-Related Adverse Drug Reaction in a Tertiary Hospital in Saudi Arabia: A Cohort, Retrospective Study.

Adverse drug reactions (ADR) are caused by a wide range of drugs including antibiotics. Currently, the prevalence and pattern of antibiotic-related ADR in Saudi Arabia are not well reported. The present study aimed to evaluate the ADR pattern caused by antibiotics in a tertiary healthcare center. This was a retrospective study conducted on 85 patients admitted to tertiary care hospitalmedical wards during the period from 2015 to 2019.The following data such as patient demographics (age, gender, weight, height), reason for admission, number of antibiotics use, comorbid condition, antibiotic(s) involved in ADR, classification of ADR, and type of ADR were recorded. Naranjo's scale was used to measure the probability of ADR. Among the 85 patients, the most frequent type of antibiotic was cephalosporins in 36.47%, followed by penicillins in 31.76% of the patients. The major type of ADR was rash (52.95%), followed by anaphylaxis reactions (10.59%) of the patients. Based on the Naranjo scale, the ADR was possible in 80% and probable in 18.82% of the cases. The presence of medical conditions displayed a significant association with the development of rashes (p=0.03). In addition, the female gender (p=0.009) and the presence of medical conditions (p=0.03) showed significant association with the development of anaphylaxis. Cephalosporin and penicillins were the most common antibiotics responsible for ADR, and the rash was the most common ADR.