Adverse Drug Reaction Monitoring Research Articles

Behavioral Science: Enhancing Our Approach to the Development of Effective Additional Risk Minimization Strategies.

Additional risk minimization strategies may be required to assure a positive benefit-risk balance for some therapeutic products associated with serious adverse drug reactions/risks of use, without which these products may be otherwise unavailable to patients. The goals of risk minimization strategies are often fundamentally to influence the behavior of healthcare professionals (HCPs) and/or patients and can include appropriate patient selection, provision of education and counselling, appropriate medication use, adverse drug reaction monitoring, and adoption of other elements to assure safe use, such as pregnancy prevention. Current approaches to additional risk minimization strategy development rely heavily on information provision, without full consideration of the contextual factors and multi-level influences on patient and HCP behaviors that impact adoption and long-term adherence to these interventions. Application of evidence-based behavioral science methods are urgently needed to improve the quality and effectiveness of these strategies. Evidence from the fields of adherence, health promotion, and drug utilization research underscores the value and necessity for using established behavioral science frameworks and methods if we are to achieve clinical safety goals for patients. The current paper aims to enhance additional risk minimization strategy development and effectiveness by considering how a behavioral science approach can be applied, drawing from evidence in understanding of engagement with pharmaceutical medicines as well as wider public health interventions for patients and HCPs.

Retrospective analysis of perioperative anaphylactic shock induced by cefuroxime

This study investigated the characteristics and frequency of perioperative anaphylactic shock induced by cefuroxime, so as to provide a reference for the safe and rational use of cefuroxime in the perioperative period. Cases of perioperative anaphylactic shock caused by cefuroxime in our hospital from 2011 to 2021 were extracted from the Adverse Drug Reaction Monitoring System. Literature reporting adverse drug reactions (ADR) including cefuroxime-induced anaphylactic shock in perioperative settings was collected from the CNKI, VIP, Wanfang, PubMed, and Web of Science databases from their respective inception to May 2022. Statistical analysis was performed for all cases of cefuroxime-induced perioperative anaphylactic shock. A total of 31 patients were included [13 men (48.1%) and 14 women (51.9%)], most of whom were over 60 years old (n=16, 59.3%); 9 (29.0%) patients had a history of drug allergy; 5 (16.1%) patients had received skin tests, but with negative results; 28 (90.3%) patients received treatment intravenously; 22 (71.0%) patients were treated after anesthesia. For 20 (64.5%) patients the ADR occurred within 10 minutes after anesthesia. The main manifestations were hypotension, dyspnea, rash, and tachycardia. For all patients, symptoms resolved after withdrawal of the drug and active rescue, and there were no deaths. A history of allergy and skin test findings may have limitations in predicting perioperative anaphylactic shock caused by cefuroxime; greater vigilance should be exercised when using cefuroxime in the perioperative period. Close monitoring is recommended for patients undergoing treatment with cefuroxime. Rescue therapy should be administered for allergic shock, and suitable response measures must be taken in a timely manner to ensure the safety of patients.

Adverse Drug Reactions and Prescription Patterns of Antiretroviral Drugs: A Longitudinal Observational Study From a Tertiary Care Hospital in Western India.

Background In 2018, the World Health Organisation (WHO) released interim guidelines, advising a change of regimens to dolutegravir-based first- and second-line antiretroviral therapy (ART), based on which, in 2021, the National Aids Control Organisation (NACO) updated its guidelines to include the tenofovir+ lamivudine + dolutegravir (TLD) regimen as a first line of therapy for all people living with HIV (PLHIV) and second- and third-line regimens to dolutegravir-based regimens. Considering this change of regimen, the adverse drug reaction (ADR) profiling and longitudinal prescription pattern of antiretroviral and concomitant medications in adult patients at the ART centre of a tertiary care hospital were assessed in this study. Methods Ninety-seven PLHIV out of all the patients who attended the ART centre from September 2021 to July 2022 were enrolled and followed up for six months. The ADRs that occurred during this period were collected along with details of prescription patterns and analyzed by descriptive statistics. Causality assessment for ADR was done using the World Health Organisation-Uppsala Monitoring Centre (WHO-UMC) scale. Results Seventy-eight percent (n=76 out of 97) of patients experienced at least one ADR, and 128 ADRs were seen in 97 patients. The most common ADRs were increased alkaline phosphatase (39.0%, n=128), dyslipidaemia (12.5%, n=128), and nephrotoxicity (10.1%, n=128). The drug most suspected of causing ADRs was dolutegravir (27.5%, n=342). The most common therapeutic regimen was TLD (71.2%, n=97). The most prescribed drug was lamivudine (30.6%, n=1183). The most prescribed concomitant medication was cotrimoxazole (15%, n=312). Conclusions Dolutegravir-based regimens have been implemented for PLHIV in a phased-out manner from previous non-dolutegravir-based ART regimens, which is in line with the recent NACO guidelines. However, it has also led to an increase in dolutegravir-associated ADRs like increased alkaline phosphatase, dyslipidaemia, and nephrotoxicity. Continuous monitoring of prescriptions and ADRs can add to our knowledge regarding their use and ADRs.

Regulatory requirement for Medical Devices

The safety and regulatory compliance of a widely used medical device have become a growing concern among a significant population. This has raised questions about the assessment of risks, monitoring of adverse drug reactions (ADR), and overall product safety. The efficacy and safety of such medical devices heavily rely on the regulations and guidelines set forth by regulatory agencies (RAs).
 In the pharmaceutical industry, regulatory affairs (RA) professionals play a crucial role in overseeing the lifecycle of healthcare products. They provide strategic, tactical, and operational guidance to ensure compliance with regulations, facilitating the efficient development and delivery of safe and effective healthcare products worldwide. Evaluating adherence to regulations requires a combination of expertise from the business, legal, and pharmaceutical domains.
 Regulatory authorities must thoroughly monitor medical device design, development, and manufacturing processes to guarantee that the products reaching the market are safe and effective. The certification process is intricate, involving multiple steps and the assessment of materials by competent authorities. In the United States, manufacturers must seek marketing authorization from the United States Food and Drug Administration (USFDA) through two primary application types: 510(k) and Pre-Market Application (PMA). In the European Union (EU), national authorities grant permission for the sale of medical devices, employing a third-party compliance system where notified bodies ensure quality assurance pre- and post-approval. In India, the Central Drug Standard Control Organization (CDSCO) licenses devices for sale and import under the CLAA framework.
 Conclusion
 Pharmaceutical regulatory affairs experts play a critical role in ensuring compliance with industry requirements for all pharmaceutical products. This review provides an overview of how medical devices are regulated and monitored in the EU, India, and the USA, emphasizing the importance of regulatory affairs in maintaining the safety and efficacy of healthcare products.

ASSESSMENT OF KNOWLEDGE, ATTITUDE AND PRACTICE (KAP) OF NUTRIVIGILANCE AMONG PHASE-2 MBBS AND POSTGRADUATE STUDENTS OF A TERTIARY CARE HOSPITAL-A CROSS-SECTIONAL OBSERVATIONAL STUDY

Objective: Nutrivigilance is a new concept in India. Several adverse drug reactions (ADRs) arising due to the use of Nutraceuticals are undermined and under-reported by prescribers. Spontaneous reporting of ADRs forms the backbone of Nutrivigilance. This paper will examine the knowledge, attitude, and practice of nutrivigilance among medical students and postgraduate doctors and discuss the need, challenges, and opportunities for improving nutrivigilance in the future.
 Methods: A Cross-sectional study was conducted between Phase-2 MBBS (UGs) and Postgraduates (PGs) of GMC, Ananthapuramu. The study tool was a validated questionnaire having 30 questions to evaluate KAP of Nutrivigilance. Data was collected in Google forms and was analyzed using SPSS 21 and P value<0.05 was taken as statistically significant.
 Results: The results revealed poor knowledge on Nutrivigilance (UGs-16% and PGs-14%). The Attitude towards Nutrivigilance was equally positive (92%, 94%) in the two groups. Practice on Nutrivigilance was 54% and 52%, respectively. There was no significant difference in KAP on Nutrivigilance between the UGs and PGs.
 Conclusion: UGs and PGs lack adequate knowledge and skill of reporting ADR, but both have a positive attitude towards Nutrivigilance programme. To increase awareness on the topic, Nutrivigilance and adverse reaction reporting of nutraceuticals must be added to the academic curriculum of undergraduate and postgraduates, thus improving the reporting and monitoring of ADRs by Nutraceuticals thus improving the health of the community.

A real-world disproportionality analysis of Everolimus: data mining of the public version of FDA adverse event reporting system.

Background: Everolimus is an inhibitor of the mammalian target of rapamycin and is used to treat various tumors. The presented study aimed to evaluate the Everolimus-associated adverse events (AEs) through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS). Methods: The AE records were selected by searching the FDA Adverse Event Reporting System database from the first quarter of 2009 to the first quarter of 2022. Potential adverse event signals were mined using the disproportionality analysis, including reporting odds ratio the proportional reporting ratio the Bayesian confidence propagation neural network and the empirical Bayes geometric mean and MedDRA was used to systematically classify the results. Results: A total of 24,575 AE reports of Everolimus were obtained using data from the FAERS database, and Everolimus-induced AEs occurrence targeted 24 system organ classes after conforming to the four algorithms simultaneously. The common significant SOCs were identified, included benign, malignant and unspecified neoplasms, reproductive system and breast disorders, etc. The significant AEs were then mapped to preferred terms such as stomatitis, pneumonitis and impaired insulin secretion, which have emerged in the study usually reported in patients with Everolimus. Of note, unexpected significant AEs, including biliary ischaemia, angiofibroma, and tuberous sclerosis complex were uncovered in the label. Conclusion: This study provided novel insights into the monitoring, surveillance, and management of adverse drug reaction associated with Everolimus. The outcome of serious adverse events and the corresponding detection signals, as well as the unexpected significant adverse events signals are worthy of attention in order to improving clinical medication safety during treatment of Everolimus.

THE ADVERSE DRUG REACTIONS OF INTERMITTENT AND DAILY REGIMENS IN THE TREATMENT OF THE INTENSIVE PHASE OF TUBERCULOSIS

Objective: To study the adverse drug reactions (ADRs) of intermittent and daily anti-tubercular therapy in intensive phase (IP), in patients attending the RNTCP unit, Government Medical College (GMC), Thrissur. Methods: A prospective observational study was done at the RNTCP unit, GMC, Thrissur, during October 2016-2017. Two hundred and thirty-five patients satisfying inclusion criteria, receiving anti-tubercular therapy as intermittent and daily regimens were selected. Demographic data, risk factors, comorbidities, and investigations were recorded and patients were followed up for IP. Results of investigations, treatment outcome, and ADRs recorded after IP. ADRs were monitored and its causality and severity were assessed. Data were entered in MS Excel and analyzed using SPSS. Qualitative variables are represented as proportions and quantitative as mean and standard deviation. Associations were analyzed using appropriate statistical tests. Analysis was performed using paired t-test p<0.05 taken as significant. Results: Orange-red urine and secretions were the most common ADR, followed by nausea, fatigue, heartburn, etc. Significant increase in random blood sugar, renal function tests (RFTs), and liver function tests (LFT) after treatment, then before noticed. 84.4% of patients from the daily group and 78% of patients from the intermittent group experienced ADRs. Causality was assessed using Naranjo’s algorithm and severity using a modified Hartwig and Siegel scale. Conclusion: The majority of patients developed ADRs, which were mild and managed symptomatically. Some reactions required alteration of therapy, reduction of drug dose, or change of suspected drug. To conclude, meticulous monitoring of ADRs in patients on anti-tubercular drugs is mandatory.

Safety and Efficacy of Treatments for COVID-19: A Pharmacovigilance Perspective

Objective: COVID-19 has generated the development of safe and effective against viral disease. In this context, the Pharmacovigilance emerges as a crucial tool to provide detailed follow-up of treatments administered to infected patients. The objective of this review is to understand the role and progress of pharmacovigilance in the COVID-19 pandemic by supporting healthcare professionals and providing information about possible Adverse Drug Reactions in patients. Methods: A review of Pharmacovigilance related to COVID-19 was conducted, addressing aspects such as the monitoring of Adverse Drug Reactions, virus structure and therapeutic advances, since 2019 to 2022, databases such as Pubmed, Scielo, Science Direct, JAMA y Redalyc were used, analyzing clinical trials, observational studies and case reports to assess the safety of drugs used in the treatments of COVID-19. Results: Pharmacovigilance provides information of risk and benefits of drugs. Reports have been implemented to detect Adverse Drug Reactions and seek pharmacological alternatives to reduce serius symptoms and complications. Conclusion: Pharmacovigilance in the COVID-19 pandemic requires efficient communication between healthcare professionals and pharmacists ensuring quality treatments and detecting possible Adverse Drug Reactions.

A study to Monitor Adverse drug reactions in a patients of Chronic Obstructive pulmonary Disease

Background: Inappropriate drug usage may preclude ideal benefit due to increased medical cost, adverse effects and mortality. Therefore drug utilization studies have become a plausible means in evaluating the healthcare systems. COPD management usually involves more than one drug which may escalate the risk of ADEs (adverse drug events). The present study aimed at assessing the current drug practice and ADEs in COPD management in ICU. Material and Methods: A prospective, single centered, observational and open labeled study was carried out in Department of Pulmonary Medicine and Pharmacology, Tertiary Care Teaching Hospital. The patient population was broadly divided into four categories based on diagnosis ‑ chronic obstructive pulmonary disease, Infections, Asthma and Others. Suspected ADRs were reported, analyzed, and causality assessment was carried out using Naranjo’s algorithm scal0065. Results: In our study, most important causative drug was Budesonide (11.1%). Causality assessment of ADR by Naranjo’s algorithm showed 11.9% probable and 88.1% possible reactions. According to WHO-UMC scale, 85.9% reactions are possible, 11.1% are probable, and 3% are unlikely. Among the 270 ADR reported, the most common ADR was oral thrush which accounted for 11.1% (n = 30) of the reported cases, followed by palpitation 11.1% (n = 30), sore throat 20 (7.4%), dizziness 17 (6.3%) cases, and headache 20 (7.4%) of reported ADR cases. Conclusion: Many research have been conducted separately on various respiratory diseases such as COPD, tuberculosis, asthma, respiratory tract infections (upper/lower), and so on. However, this study included some of the most common diseases in this field, such as COPD, tuberculosis, and respiratory tract infections. A routine patient follow-up is needed for the early detection and prevention of ADRs in order to improve patient adherence to drug therapy and provide improved drug therapy by avoiding associated morbidity and mortality.

Pediatric oncology services in Nepal: A special focus on pharmacy practice.

The role of clinical pharmacists or oncology pharmacists in pediatric oncology has been established as important in anticancer regimen review, dose calculation, recommendation, chemocounseling, identification of drug-related problems, its resolution, and, prevention and monitoring of adverse drug reactions within high-income countries. With several hospitals providing pediatric oncology services in Nepal, clinical pharmacist involvement in these hospitals is very poor. Upon reviewing the reputed organization and association focused on pediatric oncology pharmacy practice, it looks imperative for Nepal to initiate clinical pharmacy services which will further help in improving patient health outcomes. As such in this commentary, we try to accentuate the pediatric oncology services and pediatric pharmacy practice within Nepal and try to pinpoint the potential areas for clinical pharmacists to focus if they intend to provide services in pediatric oncology pharmacy practice.

Rare neurologic sequelae: A case report of toxic metabolic encephalopathy caused by carbamazepine-induced hypovolemic hyponatremia

Metabolic or secondary encephalopathies originate from non-cerebral organ system failures, often with multifactorial origins. Toxic-metabolic encephalopathy (TME) results from acute cerebral dysfunction due to metabolic disruptions, including drug effects. TME leads to altered consciousness, from delirium to coma, necessitating intensive care and mechanical ventilation. This study delves into TME, a reversible brain pathology triggered by extracerebral factors, notably drug-induced disturbances. Clinical presentation involves nonspecific altered consciousness, sometimes with asterixis or myoclonus. Carbamazepine (CBZ), a common antiepileptic medication, is linked to hyponatremia, defined by serum sodium levels below 135 mmol/l. The complexity of AED-induced hyponatremia is explored through a comprehensive patient analysis, revealing an array of symptoms including altered mentality, seizures, respiratory distress, and even coma or death. The case study dissects a patient's experience with toxic-metabolic encephalopathy secondary to CBZ-induced hypovolemic hyponatremia. This underscores the need for vigilant monitoring and management of adverse drug reactions, spotlighting the intricate interplay of drug-induced metabolic encephalopathies within clinical practice. The study reinforces the importance of awareness and tailored management strategies to enhance treatment outcomes for individuals with epilepsy.

A retrospective and observational study of the adverse drug reactions reported in a tertiary care hospital

Background: Adverse drug reaction (ADR) is considered a common cause of prolonged hospitalization and death among patients. Pharmacovigilance is essential in the surveillance of adverse drug reactions. The responsibility of a healthcare professional is to report any adverse reaction that occurs with the use of drugs. This helps in providing a database and improving the safety of patients. The aim of the study was to determine the incidence of ADR, assess causality, severity, and preventability of the submitted adverse drug reactions, increase the awareness of preventability of adverse drug reactions in health care professionals by conducting regular workshops on ADR, and document occurrence of a rare ADR. Methods: A retrospective observational study was conducted to assess the ADR reported to the ADR monitoring Centre, for the past 6 years included in the study. The data were entered into Microsoft excel and analyzed using descriptive statistics. Mean and standard deviation were calculated for the categorical data. Drugs were classified according to the class. Reactions were analyzed using scales and presented in descriptive statistics. Results: A total of 95 ADR reports were received and reported. These ADRs were associated with a total of 108 drugs that were prescribed- the occurrence of ADRs dominated among females 60% (57). Antimicrobials were causing the highest number of adverse reactions 21 (19.44%) and antituberculosis drugs and radiocontrast media were associated with the following larger number of the ADRs 19 (17.59%). Intravenous at 40% was the most common route related to the development of ADR. The most common ADR caused by antimicrobials was rash (9), antitubercular therapy commonly caused hepatitis, and chills and rigors were more common with radiocontrast media. Most of the reactions observed in the patients were moderate reactions at 52.63% with 3.16% fatal ones. Conclusions: In this study, the predominant causative drugs associated with ADR were antimicrobials, antitubercular drugs, and radiocontrast media. The number of ADRs reported though was less there was a wide range of drugs causing ADR that were reported which gave a broader spectrum for analysis. There is a requirement for active monitoring of ADRs to understand the occurrence as well as help in prevention.

Knowledge, Attitude and Practice on Adverse Drug Reactions and its Reporting Among Nursing Students

Adverse Drug Reaction (ADR) is defined as ‘a response to a medicine which is noxious and unintended, and which occurs at doses normally used in man’. ADR reporting does not yet appear to be regarded by healthcare practitioners as an integral element of standard professional practice. This is mainly because there isn't a robust and active ADR monitoring system or a culture of reporting among medical personnel. If given sufficient knowledge and skills during their undergraduate training careers, medical students could play a significant role and shift the paradigm in the successful implementation of a Pharmacovigilance program. At the moment, they don't have any significant roles due to insufficient training they received regarding ADR reporting. Thus it can be reasoned that effective educational intervention regarding ADR reporting improves Spontaneous Reporting. This study improves the Knowledge Attitude and Practice on ADRs among nursing students as they are the next generation of healthcare workers who will be the first point of contact in case a patient develops an adverse drug reaction in hospital settings. The goal of the study is to assess and improve the Knowledge, Attitude and Practice on Adverse Drug Reactions and its reporting among nursing students. The study also aimed to identify the barriers associated with reporting of Adverse Drug Reactions among the study subjects. An educational interventional study was carried out among 150 samples in selected nursing colleges of Bengaluru. The data was collected by using self designed content validated questionnaire and responses were recorded. All data obtained was processed and analyzed by using Microsoft excel. It was found that most of the student’s knowledge towards Adverse Drug Reactions and its reporting were found to be improved after suitable intervention. Lack of training, less exposure, absence of professional confidence was identified as barriers associated with reporting of ADR. With the right coaching and guidance provided by means of educational programs, this study was able to further enhance nursing student’s knowledge, attitude and practice regarding Adverse Drug Reactions and its reporting.

Active monitoring for adverse drug reactions of microtubule-damaging anti-neoplastic drug in a tertiary care hospital

Background: Cancer is a critical disease characterized by unhampered progress and metastasis of atypical aberrant cells. In India, cancer is a leading cause of increased mortality, and it is also the cause of 3 million deaths per year. Most of the anti-cancer medications originated from plants, and despite the promising anti-cancer effects of natural medications, researchers have encountered various adverse drug reactions (ADR) related to the drug. Aims and Objectives: The aims and objectives of the study are to analyze the ADR profile of cancer patients treated with microtubule-damaging anti-neoplastic and assess the preventability, severity, and causality of the documented ADR. Materials and Methods: All the cancer patients on treatment regimens containing taxanes undergoing treatment in the medical oncology department were included in this study. All the study participants were monitored for adverse effects, and any ADR reported by the patients that were diagnosed and documented in the case sheet form was recorded in the adverse reaction reporting form. The mean ± standard deviation was performed for continuous variables. Categorical variables were stated in numbers and percentages. Results: A total of sixty study participants with ADR to microtubule-damaging anticancer drugs were registered for the study and among them, 10% were males and 90% were females. The majority of adverse reactions developed in patients between 51 and 60 years of age with female dominance. A total of 114 adverse reactions were reported by the sixty study participants registered in this study, and nevertheless, more than one ADR was noticed in a greater number of patients. Conclusion: Early observation of ADR may help in either modifying the dose or changing the drug that produces adverse reactions so that damage to the organ system can be prevented.

COVID-19 pandemic period - adverse drug reactions reporting, observing, assessing and analysis at tertiary care teaching hospital, IMS-BHU Varanasi – 3-years observational study

Background: Effects of drugs that are undesirable and beyond their therapeutic effect are labeled as adverse drug reactions (ADRs). These often lead to increase hospital stay, repeated hospitalization, adversely affecting the quality of life, and perhaps, one of the causes of mortality making it a chief challenge in modern health-care system. This observational study analyzed and summarized details linked to ADRs identification, reporting, severity, treatment, and preventive measures for health professionals. Aims and Objectives: The objectives of the study are to assess and evaluate demographic profile, drug prescribed with its dosage, clinical findings, seriousness, outcome, causality, and organ system affected by concerned ADRs. Materials and Methods: An observational prospective study analyzing submitted ADRs mentioned in individual case safety reports (ICSR), mentioning demographics profile, suspected drug, involved bodily organ system, causality and reaction severity in different age groups of indoor and outdoor patients reported from 2020 January to 2022 December at ADR monitoring center, Department of Pharmacology, IMS-BHU. Performa used for ADRs reporting is ICSR, which later on transferred to the Indian database (VigiFlow) for data collection and analysis. Results: Total 1096 ADRs were identified and reported in 36-month duration, with male (629/1096) to female (466/1096) ratio of 1.35:1. On age group analysis, 74.8% (820/1096) adults (18–59 years) followed by 23.4% (256/1096) elderly (>59 years) and only 1.8% (20/1096) children and adolescents (<17 years) cases were found. Endocrine system was the most common organ system affected with 27.9% case (306/1096), succeeded by 25.4% (278/1096). ADRs were linked to the gastrointestinal system and 15.69% (172/1096) cases were related to dermatological problems. Antimicrobial drugs were most involved group, which on further analyzing and classifying revealed majority of ADRs were related to antiviral drugs, followed by antibiotics with 27.2% (298/1096) and 23.4% (257/1096) cases, respectively. Antiallergic and antifungal drug groups were found be least involved with only 1.6% (17/1096) cases each. On assessment of causality, majority of ADRs were possible in 60.40% (662/1096) cases and probable in 39.14% (429/1096) cases. Conclusion: Occurrence of ADRs is very common and perhaps a serious concern regarding well-being and safety of public as may lead to non-serious to serious health problems. This observational study identified the need of increased awareness of ADR monitoring, reporting and benefits, to fulfill the space created by under-reporting, especially in geriatrics and pediatric age group patients. A detail evaluation and removal of the barriers so that all the patients may easily approach for spontaneous reporting of side effects after start usage of any medicinal product, if any. In addition, surveillance studies emphasizing on reporting are essential for early recognition, detection, and avoidance of ADRs leading to appropriate with safe usage of drugs.

Adverse drug reaction monitoring of commonly prescribed antimicrobial agents in patients at Rama medical college, hospital and research centre, Kanpur

Background: An adverse drug reaction (ADR) is defined as a harmful or unpleasant reaction due to the use of a drug and may cause different types of effects, such as side effects. The World Health Organization states that adverse drug effects are a response to harmful and unintended medicine and occur at doses normally used in men for the prevention, diagnosis, or therapy of disease or for modifying physiological function. Aims and Objectives: The objective of the study was ADR monitoring of commonly prescribed antimicrobial agents. Materials and Methods: The study was conducted at Rama Hospital and the Research Center Mandhana Kanpur. Data were collected from the patients attending the outpatient and inpatient departments (OPD and IPD) of the medicine departments during the study period at Rama Hospital Mandhana, Kanpur. The sample size was a total of 60 patients. The study duration was conducted for 1 year. Data were collected by analyzing OPDs and IPDs in the Department of Medicine. Results: There are different types of adverse drug effects; we observed only three types of adverse drug effects in this study. The most commonly observed ADR was type A (56.66%). Out of the total ADRs reported in antimicrobial agents, skin ADRs (42.02%) and gastrointestinal tract ADRs (57.97%) are higher. There are also three different types of severity conditions observed in patients prescribed antimicrobial drugs; among them, the most commonly observed severity conditions were mild (58.33%). Conclusion: These study findings suggest that antimicrobial drugs are generally safe for most patients but can cause mild ADRs. It is important to monitor patients for ADRs while taking antimicrobial drugs and to provide appropriate treatment if necessary. Pharmacovigilance programs can help to identify and monitor ADRs, which can lead to improved patient safety.

Assessment of antitubercular treatment induced adverse drug reactions data at a tertiary care hospital

Background: Standard anti-tuberculosis (TB) treatment is highly effective, but managing adverse drug responses is a major challenge that can negatively affect treatment compliance and outcomes of an anti-tubercular treatment (ATT) regimen. Hence, monitoring of these adverse drug reactions (ADRs) is very essential wherein the drug-causing ADR can be detected and an appropriate therapeutic regimen can be given to the patient. Aims and Objectives: To assess the ATT-induced ADRs in Individual Case Safety Reports (ICSRs), to find the incidence and prevalence of ADRs due to ATT, and to analyze the causality assessment of the ADRs due to ATT. Materials and Methods: A retrospective observational study was carried out using spontaneous ICSRs data from the ADR monitoring centre at Madras Medical College, Chennai. A suspected adverse drug reaction reporting form (sADR reporting form) provided by the Pharmacovigilance Programme of India was used to collect the data of an ICSR. Results: A total of 93 ICSRs were assessed during the study period. The majority of the ADRs occurred in males (n = 55), and the maximum number of ADRs were found in the age group of 18–44 years (n = 46). The majority of the ICSRs were categorized as “serious” (n = 60), of which the maximum number of ADRs belonged to the “hospitalization/prolonged hospital stay” category (n = 45). Most of the suspected ATT drugs involved in implicating ADRs were found to be fixed-dose combination pills of Isoniazid, Rifampicin, Pyrazinamide, and Ethambutol (n = 71). Most of the ADRs were “skin and subcutaneous disorders” (n = 51) of the system organ class. The outcome of the ADRs was assessed and found that the majority of them were in the “recovering” (n = 54) category, and the majority of the ICSRs were found to be “probable” (n = 67). Conclusion: An effective implementation of a Pharmacovigilance system with early detection and management of ADRs is needed to overcome the nonadherence to TB therapy.

ADRs (Adverse Drug Reactions) related to ayurvedic medicine used in COVID-19

Background: Adverse Drug Reaction (ADR) is a response to a drug which is noxious and unintended, and which occurs at therapeutic doses. Due to a lack of systematic documentation regarding the occurrence of ADR and other issues to the safety of Ayurvedic medicines, concern about the traditional medical system has recently been increased. This is seen by a rise in safety reports and misunderstandings, especially in the recent pandemic.
 Objective: To monitor and analyse the suspected ADR to Ayurvedic medicines used in COVID-19.
 Materials and Methods: ADR monitoring data was collected through spontaneous and intensive method for a span of 2-year (April 2020 to April 2022) during the peak days of COVID-19 from the IPvCC of the National Institute of Ayurveda, Jaipur, India. The IPvCC Program is governed by NPvCC under the supervision of Ministry of AYUSH, Govt. of India, New Delhi. NPvCC is ultimately responsible to monitor and recommend regulatory interventions on the generated national ADR data.
 Result: In a span of two-year, 142 adverse drug events were reported out of which 17 were confirmed as ADR due to suspected Ayurvedic drugs.
 Conclusion: Overall review demonstrated that Ayurveda has traditionally been placed a strong emphasis on treatments that aim to heal the underlying illness while preventing the development of new illnesses.
 Bangladesh Journal of Medical Science Vol. 23 No. 01 January’24 Page : 237-245

Unveiling the Therapeutic Landscape of Oseltamivir: Exploring Drug Utilization, Adverse Reactions and Interactions with Comorbidities-A Prospective Study

Objective: This study aimed to investigate adverse drug reactions (ADRs) associated with Oseltamivir in the presence of various co-morbidities. The objective was to analyze prescription patterns, administration rationale, and ADR prevalence among patients receiving Oseltamivir for therapeutic or preventative purposes. Material and Methods: The study, conducted over six months at St. Philomena’s Hospital in Bengaluru, involved patients of all ages and genders. Ethical approval secured, the research gathered data from diverse sources for 140 patients. Naranjo’s scale was employed for causation, severity, and preventability assessments of Oseltamivir-related ADRs. Descriptive statistics were utilized to compare ADR frequencies between patients using Oseltamivir for prevention and those for therapeutic purposes. Results: The study revealed a 3.57% incidence of Oseltamivir-related ADRs, with co-morbidities contributing to 2.8% of cases, predominantly associated with hypertension. The research shed light on the importance of monitoring ADRs, particularly in the context of co-morbidities during Oseltamivir treatment. Conclusion: This research underscores the importance of monitoring ADRs in the context of co-morbidities during Oseltamivir treatment. The prevalence of hypertension as the most common co-morbidity highlights the need for careful prescription practices, especially for individuals with underlying medical conditions. These findings provide valuable insights into optimizing Oseltamivir usage in diverse patient populations.

Adverse Drug Reaction (ADR) and Pharmacovigilance: A Current Prospectives

Unwanted medication response is defined as "a significantly undesirable or harmful reaction; side effects typically indicate a risk from additional management and contact for prevention, special care, a change in the dosage schedule, or withdrawal of the product. Generally, ADR have been divided into two types: Type-A which is dose dependent and predictable on the basis of the pharmacology of the drug. e.g. beta blocker. Type-B which is unpredictable and not dose dependent. e.g. anticonvulsant. The science and activities related to the detection, assessment, understanding and prevention of adverse events or any other drug-related problem" is the definition of pharmacovigilance. Post-marketing surveillance and additional ADR monitoring techniques include prescription event monitoring, digital medical record connection, voluntary reporting by hospitals (such as the UK's Yellow Card System), cohort/case control studies, and personal case reports from physicians. Because preventing or reducing the risk of adverse drug reactions (ADRs) continues to be a challenge in our daily clinical practice, reaching the highest level of possible results from treatments continue to be a top priority for individual clinicians.