Drug Reaction

The World Health Organization (WHO) defines adverse drug reactions (ADR) as "response to a drug that is noxious and unintended and occurs at doses normally used in men for prophylaxis, diagnosis or therapy of disease, or for modification of physiological function" . Reactions can be caused by any therapeutic agent, such as antibiotics, analgesics, blood products, vaccines or radiographic contrast media . The reaction may be a well-known side effect of the drug or an undefined new reaction. Initially, many ADRs are unpredictable; they are mostly described after the post-marketing widespread usage . Age, polypharmacy and additional diseases are the main risk factors for ADRs . A study by Pirmohamed et al. [4] showed that patients admitted with ADRs were significantly older than patients without ADRs (76 versus 66 years). Therefore, ADRs pose a considerable burden among hospitalized patients who are more likely to be older and taking multiple medicines. ADRs are more common than expected among hospitalized patients; they may occur in up to 16.8% of patients during hospitalization, and 16% of these reactions may be fatal . Spontaneous ADR reporting systems are used for surveillance of drug associated risks, and in many countries, the adverse drug reporting form is the standard of care for detecting the annual rate of ADRs in inpatient or outpatient settings. Additionally, a computer software and database for case report management have been designed for monitoring ADRs at some centers in Europe . Questionnaires are an inexpensive and simple method for identifying new ADRs occurring in hospitals. The adverse drug reporting form can be filled by pharmacists, hospital doctors, nurses, and other healthcare professionals. However, many physicians are not aware of this form and are not reporting ADRs. According to the results of a survey, only 26% of physicians know which ADRs to report, 36% think that reporting is too bureaucratic, 22% do not know how to report and 18% are unaware of the need to report ADRs . Doctors and other healthcare professionals also declare that they do not have enough time to report ADRs . Nevertheless, in recent years, an increase in the proportion of reports, filled and sent by nurses and pharmacists, has been noticed . At our institutions, we systematically monitor ADRs occurred during inpatient care. The ADR reporting forms are completed by our inpatient nurses immediately after an unwanted drug reaction has been detected. These forms include patients' demographic details, culprit drug, details of the reaction and the management of ADR (Figure ) [8]. The ADR team at our hospital, which comprises a pharmacist, an allergist, a pulmonologist, and a nurse, is responsible for collecting data from the forms and organizing educational activities for improving ADR management. The allergist arranges training activities according to the needs of the staff and the pharmacist submits data to our national pharmacovigilance data system. Two training sessions are organized each year for inpatient nurses; these trains consist of updated education about drug interactions, ADRs, allergic drug reactions, and methods for appropriately filling out the ADR reporting form. Our reporting system provides valuable information to our healthcare professionals and helps them to be aware of the factors related to ADRs and prevention strategies to reduce the occurrence of unwanted drug reactions, accurate diagnosis, and effective management of ADRs, such as adrenaline use in anaphylaxis. Our computer based data collecting system will also be available in the near future and will help improve the service we provide.

___________________________________________________________________________________________________________________ SJS/TEN is a rare, potentially life threatening, immune-complex-mediated cutaneous adverse drug reaction. Almost one-third of cases are idiopathic. This syndrome is associated with drug treatment as well as infectious agents, neoplasia, and connective tissue diseases. Here we report a 36-year-old male presenting with toxic epidermal necrolysis after 2 days of oral acyclovir.

Alterations of pharmacological or clinical responses that occur during polytherapy are defined as drug-drug interactions (DDIs) (1). DDIs may lead to life-threatening adverse reactions or therapeutic failure by influencing the therapeutic efficacy of drugs. Five to twenty percent of serious adverse drug reactions due to DDIs have been reported to result in hospitalization or death (2). Many factors such as age, multiple diseases, and sex have been found to be risk factors for potential DDIs (3). Occurrence of DDIs is correlated with the number of prescriptions. Lima and De Bortoli Casiani demonstrated that incidence of DDIs increases by 10%-20% in patients using 10-20 drugs (4). In the elderly, DDIs may be diagnosed as adverse outcomes associated with drug therapy (5). The impact of DDIs on the mortality rate of elderly patients was determined in a retrospective research (6). Consideration of DDIs for patients in the intensive care unit (ICU) is critical for the quality of the patient's life. Clinically important DDIs are more likely for ICU patients with many medications, comorbid diseases, and altered organ functions (7). The rate of occurrence of potential DDIs in ICU patients (54%) was reported to be two times that of patients in other wards (8). The risk of DDIs can increase the length of hospital stay because new drugs are often added to an existing drug therapy (9). Potential DDIs being reported early may prevent many complications, and this increases the medication safety of patients and promotes the quality of the patient's life. The present study was planned to detect the frequency and clinical severity of the potential DDIs of ICU patients. This is an observational and prospective study performed with the internal medicine patients of the ICU at the Marmara University Pendik Education and Research Hospital. This academic hospital has an eight-bed and closed-format ICU where pediatric and surgical patients are hospitalized in different ICUs and there is no data management system in the ICU to check on the occurrence of possible DDIs. The Medical Pharmacology Department organized reports on the first visit of the Background/aim: Drug-drug interactions (DDIs) can impact patient safety. Occurrence of clinically important DDIs is higher for intensive care unit (ICU) patients. This observational study aimed to evaluate the potential DDIs in medical ICU patients of a university hospital. The Medical Pharmacology Department organized consultation reports for ICU patients in order to detect the DDIs. To focus on clinically important DDIs, interactions in the C, D, or X risk rating categories of the Lexi-Interact online database were analyzed. Frequency and clinical risk rating categories of DDIs were detected. Relationship between number of prescriptions and DDIs were assessed. The most frequent drug/drug groups were identified. Results: Of 101 ICU patients, 45.5% were found to have DDIs. We detected 125 C (72.2%), 37 D (21.4%), and 11 X (6.4%) risk category interactions. A statistically significant increase in the number of DDIs was shown with the number of prescriptions (P = 0.002). The most frequent DDIs were between agents acting on the cardiovascular system and corticosteroids (12.8%). Results of this study show that pharmacological consultation plays a critical role in the recognition of DDIs for improvement of medication management and effective therapeutic endpoints without any adverse or toxic reactions.

Hypersensitivity reactions to aspirin (acetylsalicylic acid) and other nonsteroidal anti-inflammatory drugs (NSAIDs) constitute only a subset of all adverse reactions to these drugs, but due to their severity pose a significant burden to patients and are a challenge to the allergist. In susceptible individuals, NSAIDs induce a wide spectrum of hypersensitivity reactions with various timing, organ manifestations, and severity, involving either immunological (allergic) or nonimmunological mechanisms. Proper classification of reactions based on clinical manifestations and suspected mechanism is a prerequisite for the implementation of rational diagnostic procedures and adequate patient management. This document, prepared by a panel of experts from the European Academy of Allergy and Clinical Immunology Task Force on NSAIDs Hypersensitivity, aims at reviewing the current knowledge in the field and proposes uniform definitions and clinically useful classification of hypersensitivity reac...

Background: Survival time for Human Immune virus infected patients is the survival of HIV patients from date of antiretroviral therapy initiation to still one of the following events registered; death, lost to follow up, transferred out to other health institutions or alive under follow up.
Objective: To assess survival status  of HIV infected patients and its predictors in Doctor Bogalech Gebre memorial general hospital.
Methods and Materials: A retrospective cohort study was conducted among 299 randomly selected adult HIV patients who initiated antiretroviral therapy at Doctor Bogalech Gebre memorial general hospital between May 2017 and August 2024. The Cox proportional hazards regression model was used to identify the predictors of the survival status of the patients. The strength and significance of associations between variables was assessed using an adjusted hazard ratio (AHR), its 95% confidence interval (CI), and p-values.
Results: A total of 299 adult HIV patients on ART contributed to 773-person year observation and 173(57.9%) were active, 74(24.7%) were died, 28(9.4%) were transfer out and 24(8.0%) were lost follow up. The estimated death rate was 14%, 17%, 20.4%, 22.7%, 24.1%, 24.7%, 24.7%, and 24.7% at 6, 12, 24, 36, 48, 60, 72 and 84 months follow up period respectively. Out of 74 deaths, 42(56.8%) were died within the first 6 months. The overall incidence rate of death during ART treatment was 9.57 per 100-person years observation (PYO). In multi variable analysis Presence of comorbidity (AHR: 1.801, 95% CI: 1.051-3.108), Poor ART adherence level (AHR: 13.368, 95% CI: 5.981-29.878) bedridden baseline functional status (AHR: 2.629, 95% CI: 1.101-6.288) and sever hemoglobin level (AHR: 4.526, 95% CI: 1.434-14.286) were predictors of survival status and statistically significant covariates.
Conclusion: This study had identified the independent significant predictors of survival status of HIV infected patients Received ART, factors include patients with presence of comorbidity, bedridden baseline functional status, Poor ART adherence level and sever hemoglobin level should be monitored closely by their clinicians.
Keyword: HIV, ART, Survival Status

The aim of the present study was to monitor adverse drug reactions (ADRs) in the Medicine out patient department (OPD) of a University Teaching Hospital. Method: A prospective evaluation of the ADRs reported in the Department of Medicine of our University Teaching Hospital over a period of 4months was conducted. Results: During the study period, a total of 600 patients visited the Medicine OPD and 122 ADRs were reported. Out of 122 reports that were identified, a higher percentage of ADRs in males (52.4%) was observed as compared to females (47.5%). Of the 122 ADRs, 50 were found to be mild (41.0%), 49 moderate (40.2%), and 23 severe (18.2%). A total of 71 (58.0%) ADRs were observed in patients receiving 4 or more medications concurrently. Conversely 46 (37.7%) ADRs were detected in patients using 3 or less medicines. The largest number of reports were associated with antihypertensive therapy (39.3%), followed by antimicrobials (31.1%) and antidiabetics (10.7%). Amongst the organ systems affected, gastrointestinal ADRs constituted a major component (24.7%) followed by skin reactions (22.2%). On causality assessment, nearly 29.5% ADRs were considered as probable, 33.6% possible and 6.6% could not be categorised and were placed under unassessable. Conclusion: The present work is the maiden pharmacovigilance study conducted at our university teaching hospital. The data presented here will be useful in future, long term and more extensive ADR monitoring in the hospital and in *

Background: Iohexol is widely used radiocontrast media in the radiology departments for the diagnostic imaging purpose. As very few studies are carried out focusing on safety profiles of this contrast media. This study was conducted to know the profile of adverse drug reactions (ADRs) induced by Iohexol in patients who are undergoing the contrast-enhanced computed tomography (CECT) examination.Methods: Total 106 patients from CT unit of radiology department were observed for adverse drug reactions from Iohexol contrast media in 2 months duration. Acute ADRs were recorded immediately after contrast media administration by observation and personal interviews and delayed ADRs are recorded by follow up after 24hrs.Results: Total 23 out of 106 patients who had undergone CT imaging investigations by Iohexol contrast media had developed ADRs. Total 29 ADRs were developed in 23 patients. Out of these, 22 ADRs were acute and 7 ADRs were delayed reactions. All acute ADRs were of “probable” ca...

Electronic Health Records (EHR) narratives are a rich source of information, embedding high-resolution information of value to secondary research use. However, because the EHR is mostly in natural language free-text and highly ambiguity-ridden, many natural language processing algorithms have been devised to extract meaningful structured information about clinical entities. The performance of the algorithms however, largely varies depending on the training dataset as well as the effectiveness of the use of background knowledge to steer the learning process. In this paper we study the impact of initializing the training of a neural network natural language processing algorithm with pre-defined clinical word embeddings to improve feature extraction and relationship classification between entities. We add our embedding framework to a bi-directional long short-term memory (Bi-LSTM) neural network, and further study the effect of using attention weights in neural networks for sequence labelling tasks to extract knowledge of Adverse Drug Reactions(ADR). We incorporate unsupervised word embeddings using Word2Vec and GloVe from widely available medical resources such as Monitoring in Intensive Care (MIMIC) II corpora, Unified Medical Language System (UMLS) as well as embed pharmaco lexicon from available EHR. Our algorithm implemented on two datasets, show that our architecture outperforms baseline Bi-LSTM or Bi-LSTM networks using linear chain and Skip-Chain conditional random fields (CRF).

Electronic Health Records (EHR) narratives are a rich source of information, embedding high-resolution information of value to secondary research use. However, because the EHR is mostly in natural language free-text and highly ambiguity-ridden, many natural language processing algorithms have been devised to extract meaningful structured information about clinical entities. The performance of the algorithms however, largely varies depending on the training dataset as well as the effectiveness of the use of background knowledge to steer the learning process. In this paper we study the impact of initializing the training of a neural network natural language processing algorithm with pre-defined clinical word embeddings to improve feature extraction and relationship classification between entities. We add our embedding framework to a bi-directional long short-term memory (Bi-LSTM) neural network, and further study the effect of using attention weights in neural networks for sequence labelling tasks to extract knowledge of Adverse Drug Reactions(ADR). We incorporate unsupervised word embeddings using Word2Vec and GloVe from widely available medical resources such as Monitoring in Intensive Care (MIMIC) II corpora, Unified Medical Language System (UMLS) as well as embed pharmaco lexicon from available EHR. Our algorithm implemented on two datasets, show that our architecture outperforms baseline Bi-LSTM or Bi-LSTM networks using linear chain and Skip-Chain conditional random fields (CRF).

Objective: It is commonly reported that medicines have side effects related to dermatological practice. However, it is extremely difficult to establish how commonly, or rarely skin-related medication side effects occur. Common dermatological side effects include rash, pruritus, and photosensitivity. Objective: To demonstrate the dermatological side-effects of the most commonly prescribed medications in the United Kingdom. Methods: This paper discusses dermatological side-effects of the commonly prescribed medications, including uncommon or rare manifestations such as angioedema and Stevens - Johnson syndrome (SJS). The list used for the most frequently prescribed drugs in the United Kingdom was created by nurses. This list was compared to the British National Formulary to demonstrate the reported frequency of occurrence of dermatological side-effects or complications. Conclusion: The top 100 prescribed medication cause a number of dermatological side effects that need to be consider...

Hypersenzitivní syndrom (hypersensitivity syndrome)/DRESS (drug rash with eosinophilia and systemic symptoms, DRESS) syndrom (jiný termín i polékový hypereozinofi lní syndrom) je vzácně se vyskytující alergický, život ohrožující nežádoucí účinek některých léků postihujících i srdeční funkci, s vysokou mortalitou a dlouhodobým srdečním selháním. U 28leté ženy došlo dva měsíce po stanovení diagnózy DRESS na podkladě podávání sulfasalazinu k rozvoji fulminantní eozinofi lní nekrotizující myokarditidy. Po intenzivní multiorgánové podpoře se pacientka zotavila a její srdeční funkce se normalizovala. O osm měsíců později došlo k recidivě s rychlou progresí k refrakternímu kardiogennímu šoku a úmrtí. V článku upozorňujeme na vzácné a nedostatečně diagnostikované onemocnění s nepříznivou prognózou, které je nutno včas odhalit a léčit.

Background: Adverse Drug Reactions (ADR) is worldwide health issues associated with increased morbidity and mortality. These issues are addressed by pharmacovigilance, in which nurses can play a crucial role by reporting ADRs, but their participation is very poor in this field. Purpose: This study aimed to evaluate the impact of training session on nursing students' knowledge, attitude and practice (KAP) towards pharmacovigilance. Methods: A quasi experimental, cross sectional, observational study was conducted among 315 nursing students at tertiary institutes. Nursing students completed a pre-validated questionnaire before and after a training session covering pharmacovigilance concepts. Pre and post session responses were compared using chi-square and paired t-tests. Results: Almost 64.13% reported no prior training regarding pharmacovigilance. The percentage recognizing ADR reporting as a professional obligation increased to 92.7%. After the session, 97.14% came to know that anyone can report ADR. Conclusion: The educational intervention effectively improved the knowledge and importance of pharmacovigilance, positive attitude in responsibility, and competency of ADR reporting in practice among the nursing students.

The therapeutic potential of phytochemicals lies in their ability to modulate multiple diseaserelevant targets simultaneously, yet conventional reductionist assays often fail to capture this polypharmacology. Network pharmacology, when integrated with in silico methods such as molecular docking, molecular dynamics simulations, and cheminformatics, offers a powerful systems-level framework to decode the multi-target mechanisms of plant-derived compounds. This review critically evaluates the state of the art, comparing computational tools, databases, and validation strategies. I synthesize case studies across inflammation, cancer, and neurodegeneration to identify best practices and persistent pitfalls, including overreliance on binding affinity cutoffs, neglect of pharmacokinetic constraints, and insufficient experimental validation. Emerging solutions, such as machine learning-based target prediction, pharmacophore-constrained network analysis, and integrated ADMET filtering, are discussed. I conclude that the future of phytochemical network pharmacology lies in quantitative, predictive models that prioritize functional network perturbation over simple topological metrics, coupled with standardized experimental validation pipelines.

Considering increased use of cardiovascular drugs and limitations in pre-marketing trials for drug safety evaluation, post marketing evaluation of adverse drug reactions (ADRs) induced by this class of medicinal products seems necessary. Objectives: To determine the rate and seriousness of adverse reactions induced by cardiovascular drugs in outpatients. To compare sex and different age groups in developing ADRs with cardiovascular agents. To assess the relationship between frequencies of ADRs and the number of drugs used. Methods: This cross-sectional study was done in cardiovascular clinic at a teaching hospital. All patients during an eight months period were evaluated for cardiovascular drugs induced ADRs. Patient and reaction factors were analyzed in detected ADRs. Patients with or without ADRs were compared in sex and age by using chi-square test. Assessing the relationship between frequencies of ADRs and the number of drugs used was done by using Pearson analysis. Results: The total number of 518 patients was visited at the clinic. ADRs were detected in 105 (20.3%) patients. The most frequent ADRs were occurred in the age group of 51-60. The highest rate of ADRs was recorded to be induced by Diltiazem (23.5%) and the lowest rate with Atenolol (3%). Headache was the most frequent detected ADR (23%). Assessing the severity and preventability of ADRs revealed that 1.1% of ADRs were detected as severe and 1.9% as preventable reactions. Women significantly developed more ADRs in this study (chi square = 3.978, P<0.05). ADRs more frequently occurred with increasing age in this study (chi square = 15.871, P<0.05). With increasing the number of drugs used, the frequency of ADRs increased (Pearson=0.259, P<0.05). Conclusion: Monitoring ADRs in patients using cardiovascular drugs is a matter of importance since this class of medicines is usually used by elderly patients with critical conditions and underlying diseases.

Objective: Adverse drug reactions (ADRs) are known as a cause of hospital admission. We have carried out a prospective study to characterize and assess the frequency, probability, preventability, and severity of ADRs, which lead to hospital admission in children. Methods: In a prospective observational study, a cohort of children admitted to a tertiary pediatric hospital was randomly screened to assess ADR as the cause of admission from June 2014 to January 2015. ADRs causing admissions were detected based on patients' records, interviewing their parents, and confirmation by medical team. The probability of the ADRs was assessed based on WHO criteria and Naranjo tool. The preventability assessment was performed using Schumock and Thornton questionnaire. Findings: Of the 658 evaluated emergency admissions, 27 were caused by an ADR giving an incidence of 4.1%. Among ADRs, 37.1% were estimated to be preventable. Antibiotics were the most common medication class which caused hospital admission. Conclusion: Pediatric pharmacotherapy still needs evidence-based strategies to improve child care including education, monitoring, planning for medications after ADR occurrence, and implementing preventive measures when applicable.

Burden of adverse drug reactions (ADRs), in home-environment and domestic settings, is unknown.To discuss the epidemiology of reported ADRs to 13-Aban drug and poison information center (DPIC) and to discuss the burden of hospitalization caused by these ADRs from commonly implicated therapeutic groups.A retrospective analysis of the yellow card schemes of suspected ADRs reported to the 13-Aban DPIC was conducted from 21 March 2013 to 21 November 2016 inclusive.Characteristics of the ADRs, such as the sex and age of the patient, the therapeutic group involved, and the medical outcome of the exposure, were examined. ADR Hospitalization (ADRH) index was calculated for each drug group by dividing the number of ADR-related hospitalizations with total number of reported ADR cases (n = 748), and then multiplying by 100.ADRs were reported for 748 patients representing 5 cases per 1000 enquiries to the 13-Aban DPIC over almost 4-years of the study period. Public were responsible for reportin...

RATIONALE: Penicillin allergy testing has historically been underutilized in the inpatient setting where it may directly impact treatment. We expanded penicillin allergy testing to hospitalized patients to determine the rate of penicillin hypersensitivity, the barriers of inpatient testing, and the subsequent use of beta-lactams or cephalosporins. METHODS: We evaluated 55 hospitalized patients from 9/2017-8/2018 with reported penicillin allergy that were referred by primary teams or specialists if beta-lactams or cephalosporins were desired for prophylaxis or to treat underlying infection. Qualifying patients then underwent skin testing followed by oral Amoxicillin challenge. RESULTS: 37 patients (67%) underwent testing with 35 (94%) proving to be tolerant of beta-lactams or cephalosporins. Of the patients that were tested, direct drug challenges were administered to 19 (51%) patients based on clinical history, with no reported adverse outcomes. Of the 35 tolerant patients, 25 (71%) had a beta-lactam added to their treatment, 9 (26%) received a cephalosporin, whereas 4 (11%) received other antibiotics. Barriers to testing included patients with incompatible medication use (4), clinical instability (5), or delayed symptoms (4); 4 patients declined testing. CONCLUSIONS: Our results suggest that 6% of patients with reported penicillin allergy exhibit true sensitivity, consistent with previous reports. A majority of patients were able to tolerate direct drug challenge, indicating that improved utilization of clinical history can simplify testing protocols and may prove sufficient for many patients. Additionally, most subsequent treatment plans for tested patients included a beta-lactam or cephalosporin. Despite barriers, inpatient penicillin allergy testing may decrease reported allergies and broaden antibiotic options.

In Tanzania, pharmacovigilance system is implemented by Tanzania Food and Drugs Authority (TFDA) that monitors drug use countrywide. TFDA is the main national custodian for recording, analyzing and disseminating safety information that is generated through conventional health care facilities. Since the introduction of Care and Treatment Centre (CTC) in the health care system, little has been achieved on translating safety information from these facilities to the TFDA. Since the inception of national pharmacovigilance framework in 2003 there has been no systematic operational research to map the gaps in the existing pharmacovigilance system. Furthermore, it is not clear if there is adequate training and supervision. It is, therefore, important to strengthen antiretroviral therapy (ART) related adverse drug reactions (ADRs) reporting by mapping gaps in implementation of pharmacovigilance (PV) system. Information obtained will assist in addressing training needs to ensure effective rep...

Background: Pharmacovigilance (PV) is essential for ensuring drug safety by monitoring and reporting adverse drug reactions (ADRs). Despite the presence of national programs such as the Pharmacovigilance Programme of India (PvPI), underreporting of ADRs remains a challenge. This study aimed to evaluate the knowledge, attitude, and practice (KAP) regarding pharmacovigilance among healthcare professionals in Warangal, Telangana, and to identify gaps influencing ADR reporting. Materials and Methods: A prospective observational, questionnaire-based study was conducted over six months among 200 healthcare professionals, including doctors, nurses, and pharmacists, in hospitals, pharmacies, and colleges of Warangal. A pretested 20-item structured questionnaire assessed KAP domains. Descriptive statistics, including frequencies and percentages, were used to analyze responses. Results: Most participants (84.3%) correctly defined pharmacovigilance, and 91% were aware of the PvPI. A majority (95.2%) agreed ADR reporting is necessary, and 96.2% supported teaching PV in detail to healthcare professionals. However, only 17.5% had ever reported an ADR, despite 65.4% encountering one during practice. While 67.2% had seen an ADR reporting form, only 45.4% had received training on ADR reporting. Key barriers identified included lack of time (46.9%), difficulty in determining causality (24.6%), and insufficient training. Pharmacists constituted the largest group of respondents (45.5%), followed by nurses (34.6%) and doctors (19.9%). Conclusions: The study revealed satisfactory knowledge and positive attitudes toward pharmacovigilance but poor reporting practices among healthcare professionals. Strengthening pharmacovigilance requires targeted training, simplified reporting procedures, institutional support, and integration of PV into professional education. Bridging the gap between awareness and practice is crucial for improving ADR reporting and ensuring patient safety