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Posterior reversible encephalopathy syndrome (PRES) is a clinicoradiological condition characterized by headaches, seizures, confusion, and visual impairment. It typically causes transient lesions in the posterior white matter in magnetic resonance imaging (MRI) of the brain. PRES induced by chemotherapy is uncommon in oncology but can be a significant neurological event. The exact cause of PRES remains unclear. This case report describes a 15-year-old female patient with acute lymphoblastic leukemia who developed PRES following chemotherapy with prednisolone (100 mg), vincristine (2 mg), and daunorubicin (40 mg) as per the modified Berlin-Frankfurt-Munster (95/2002) protocol. She developed headaches, partial seizures, and elevated blood pressure 1 day after starting chemotherapy. Brain MRI showed T2 and fluid-attenuated inversion recovery hyperintensities in the bilateral cerebral parenchyma, brainstem, and cerebellum. She was treated with levetiracetam (500 mg stat and then 1.5 g BD) for seizures, amlodipine (5 mg) for hypertension, and paracetamol (650 mg TDS) for headaches. Her symptoms improved and resolved within 2 days. The event was deemed possibly related to the chemotherapy drugs according to the World Health Organization-Uppsala Monitoring Centre causality assessment system.
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Dipeptidyl-peptidase 4 (DPP-4) inhibitors are one of the most commonly used anti-diabetic drugs because of their established safety and efficacy. Bullous pemphigoid which is an autoimmune blister skin disorder associated with DPP-4 inhibitors is a recognized adverse drug reaction (ADR) reported in some Southeast Asian Nations but has not been reported earlier from India. It is an uncommon, serious treatment with emergent adverse effects. Here, we report a series of five cases of DPP-4 inhibitor Linagliptin-induced bullous pemphigoid reaction in Type 2 diabetes mellitus patients. We are reporting five cases that showed various clinical manifestations in terms of gender (males 4), duration of diabetes (average 7.2 years), glycemic control (average HbA1C 6.7%), and latency period (average 3.6 weeks) for development of the ADR. Quality of life and treatment satisfaction were severely impacted by this ADR. Withdrawal of Linagliptin, use of topical and oral steroids and immunosuppressant like azathioprine were prescribed and effective for improving the lesions of all the cases. As per the World Health Organization-Uppsala Monitoring Center scale, causality was established as “probable” for all the cases. This case series serves to bring to the notice of prescribers regarding this important cutaneous ADR with the use of Linagliptin. This case intends to improve awareness among clinicians regarding the possibility of this cutaneous ADR among diabetic patients to facilitate early diagnosis and intervention.
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Background: It is estimated that only 6–10% of all adverse drug reactions (ADRs) are reported. Although India is participating in the pharmacovigilance program, its reporting is still in its initial stages. It is important to sensitize health-care professionals regarding ADR reporting and pharmacovigilance helping in better reporting. Educational interventions have been widely shown to be effective at improving the rate of ADR reporting among healthcare workers. Aims and Objectives: The primary objective of this study is to understand the knowledge of health-care professionals regarding ADR reporting and pharmacovigilance and also to know the effectiveness and outcome of the pharmacovigilance workshop. Materials and Methods: A retrospective audit of the data obtained from the workshops conducted on pharmacovigilance over 2 days in April 2023 was conducted after obtaining the requisite permission from the Institutional Ethics Committee. The workshops were conducted by the ADR monitoring center of Terna medical college, Nerul for the health-care professionals. A questionnaire consisting of 21 questions was used during the workshop for both pre-test and post-test. The questions tested the knowledge and attitude of health-care professionals. At the end of the session, feedback was taken regarding the workshop. The data were entered into Microsoft Excel and subjected to descriptive statistics. A paired t-test was done for the pre-test and post-test scores on Microsoft Excel. Results: In total, there were 67 participants in the workshop, 51 (76.12%) were nursing staff of different departments. Thirteen (19.4%) were duty medical officers, 1 (1.49%) was pharmacist and 2 (2.99%) were from pathology laboratory. A paired t-test was done for the pre-test and post-test marks of the participants, and the P-value was calculated to be 0.00000297 showing a statistically significant difference between the scores. About 92.53% agreed that it is important to report an ADR. About 71.64% agreed that reporting a known ADR still contributes to the system. Conclusion: The results of the present study demonstrate that the attitude of health-care professionals is positive regarding reporting an ADR. The improvement of the knowledge of the professionals was good after the workshop. It also concludes that workshops on pharmacovigilance and ADR reporting are necessary to increase awareness among health-care professionals on pharmacovigilance. ADR reporting is important to reduce the morbidity associated with the use of medications. There is a necessity to conduct interventions in the form of more workshops regularly to improve ADR reporting.
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Standard anti-TB treatment (ATT) is highly effective and one of the great challenges for ATT success is 4 management of TB drugs toxicity. This toxicity is manifested through adverse drug reactions (ADR) . NTEP, the then RNTCP had adopted thrice weekly regimen for treatment of drug sensitive TB until the year 2016. Various research studies have shown that relapse rates were higher with intermittent regimen. Hence the programme has now shifted to daily regimen for treatment of all drug sensitive TB patients. The adverse drug reactions with daily regimen may be higher compared to intermittent regimen, therefore, it is necessary to clinically monitor the patients on treatment. ToObjectives: estimate the proportion of ADR among patients receiving rst line antitubercular drugs in Respiratory Medicine department of AGMC and also to determine the factors associated with ADR in different phases of DOTS therapy. Cross-Methodology: sectional study hospital-based observational study and was conducted for a period of 18 months from Jan 2022 to June 2024 at AGMC & GB Pant Hospital in the department of Respiratory Medicine, among newly diagnosed drug sensitive tuberculosis patients of both pulmonary and extra-pulmonary registered for rst-line ATT during the study period In the presentResults: study, 105 tuberculosis patients were included. There were 81 male and 24 female patients. Out of total 105 cases diagnosed with Tuberculosis, 60 cases (57.1%) developed ADR and 45 cases (42.8%) did not develop any ADR to First line ATT. It was found that majority of the patients suffered from Liver dysfunction (55%) followed by Gastrointestinal symptoms (20%), Fever (11.67%), Neurological symptoms (6.67%), generalised weakness and allergic drug reactions (3.33% each). AConclusion: majority of these ADRs occurred during the intensive phase of treatment. Signicant risk factors for developing adverse reactions to antitubercular drugs include male sex, malnutrition, alcohol consumption, cigarette smoking, co-morbidities and having pulmonary tuberculosis. Therefore, healthcare providers treating tuberculosis must identify these vulnerable patient groups to prevent, diagnose, and manage these ADRs. By doing so, patients can adhere to treatment and achieve higher cure rates.
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Background: Off-label use of drugs (OLUDs) is relatively common in pediatric and this may be associated with adverse drug reactions (ADRs). The studies about the safety of drugs used in children cannot be applied to safety of drugs during OLUDs as drug is used in way that is different from that described in regulatory body. Hence, it is worthwhile to evaluate the off-label status of the suspected drugs causing ADRs. Aims and Objectives: The aim of the study was to analyze the pattern of ADRs occurring during OLUDs in pediatric patients from the spontaneously reported ADRs cases at the pharmacovigilance unit of a tertiary care hospital. Materials and Methods: Single center, retrospective, observational study was conducted in the department of pharmacology. ADRs spontaneously reported from January 2016 to December 2017, which occurred during OLUDs in children, where causality is certain, probable and possible. Results: A total of 46 ADRs occurred during OLUDs in 44 patients, these patients received 174 medicines among which 66 were off-labeled drugs. Off-label drugs mainly belonged to anti-infectives for systemic use (70.31%) and it is associated with 30 ADRs (68.18%). The most commonly affected organ system is skin and subcutaneous tissue (43.18%). Conclusion: OLUDs is associated with ADR, so caution should be taken while prescribing a drug in off-label manner in children.
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Background: Adverse drug reaction (ADR) reporting is the integrity of healthcare professionals (HCPs) to counteract fatal outcomes aroused by the use of medications during therapy. The underreporting of ADRs imposes major problems globally. The pharmacovigilance program plays a key role in detecting and preventing ADRs. Targeting the upcoming younger generation of HCPs and sensitizing them towards ADR reporting in their clinical practice is essential. Aims and Objectives: The main objective of our study is to measure the knowledge, attitude, and practice of interns and postgraduates at our institute towards ADR reporting and pharmacovigilance. Materials and Methods: This study was a cross-sectional study conducted on interns and postgraduates of a tertiary care teaching hospital in Udaipur, Rajasthan. A set of 28 standard questions related to knowledge, attitude, and practice of pharmacovigilance and ADR reporting were distributed among 106 students after taking the ethical approval from the institute. The collected data were analyzed using SPSS (version 20) software in percentage. The Chi-square test (?2) was used, and P < 0.01* was considered significant statistically. Results: In our study, we found most of the participants were in 21–30 age groups (84.19%); male participants were (67%) in comparison with females (33%). The majority of interns showed their interest in participation (66%) rather than postgraduates (34%) in this study. The overall knowledge (14.645, P = 0.01), attitude (14.64, P = 0.01), and practice (35.712, P = 0.01) of HCPs were found to be significant. Conclusion: We conclude from this study that both interns and postgraduates have good knowledge of ADR reporting, but interns lack practice in their daily duties due to fear of heavy paper work, and postgraduates lack attitude towards ADR reporting due to heavy duty schedules. Most of the participants, i.e., interns and postgraduates, felt ADR reporting was their primary responsibility along with patient safety. Recurrent training and sensitization of upcoming medical professionals about ADR reporting will impart better patient compliance and eradicate fatal outcomes. They also suggest a separate working body needs to keep by institutions to collect the ADR reports during their busy duty schedules.
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Objective: Cancer being a deadly disease and global threat, necessitate the use of anticancer agents. Hence, continuous Adverse Drug Reaction (ADR) reporting should be carried out in the oncology departments of health care systems. The objective of the study was to assess commonly prescribed anticancer agents and report ADRs associated with the anticancer treatment. Material and Method: This observational, cross-sectional study was done in the Radiotherapy department of a tertiary care teaching hospital for a period of three months. Female Patients of breast carcinoma attending Radiotherapy department for chemotherapy were included. Patients were enquired about occurrence of any ADRs and details were noted. Preventability and severity of ADRs were assessed by modied Schumock and Thornton scale. Result: A total of 60 patients were included in the study. Nausea was the most commonly reported ADR followed by tingling of feet, vomiting, alopecia and abdominal pain. Conclusion: Inspite of various prophylactic antiemetic treatment majority of patients had nausea and vomiting which indicates that more vigorous prophylactic measures to prevent emesis need to be undertaken since these ADRs of the antineoplastic drugs are usually preventable.
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Background: Adverse drug reactions (ADRs) are one of the leading causes of mortality and morbidity. It is well established that the spontaneous reporting of ADR by the health-care professionals determines the success of a pharmacovigilance program, but not followed in practice. As the major reasons for the poor ADR reporting were said to be lack of awareness, training, and time, we did this study to evaluate the knowledge, attitude, and practice of nurses and junior doctors in our hospital towards ADR. Aims and Objectives: To assess the knowledge, attitude, and practice of pharmacovigilance among interns, postgraduates, and nurses at Hassan Institute of Medical Science Teaching Hospital. Materials and Methods: This is a cross-sectional questionnaire-based study conducted among interns, postgraduates, and nurses working at Hassan Institute of Medical Sciences, Hassan Karnataka. This validated questionnaire had 19 questions pertaining to knowledge, attitude, and practice of pharmacovigilance. Results: The questionnaire was sent to 120 interns, 89 postgraduates, and 375 nurses. Of which, 410 responded (70.2% response rate). Interns had better knowledge than postgraduates and nurses, but a good attitude was seen among all but comparatively better among the postgraduates. Still, the practice of ADR reporting is poor overall. Even though 74% of them came across ADR, only 32% managed to report them. Conclusion: This study found that even though knowledge regarding pharmacovigilance among the health-care professionals involved in the study is good, the rate of ADR reporting is very low. Taking advantage of their better attitude, adding a bit more education regarding its importance and training, ADR reporting can be very well improved.
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Background: Adverse drug reactions (ADRs) are unintended and harmful reactions to medications that occur at doses normally used for therapeutic purposes. The reporting of ADRs is essential for the identification and prevention of ADRs. Aims and Objectives: The aim of the study was to estimate the frequency and distribution of spontaneously reported ADRs in the tertiary care teaching hospital. Materials and Methods: A retrospective cross-sectional study was conducted from July 2020 to June 2023, from spontaneously reported ADRs by the ADR Monitoring Centre, MGM Medical College, Kishanganj, Bihar. Distribution of age, gender, department, medication groups, and systems involved were examined. Utilizing certain scales, causality, severity, and preventability were evaluated. Results: Total 47 ADRs were reported during the study period. The most common ADRs were cutaneous ADRs (n = 19,40.43%) followed by the central nervous system (CNS) (n = 12, 25.53%), gastrointestinal system (GI) (n = 9, 19.15%), musculoskeletal (n = 4, 8.51%) and others. The most commonly implicated drugs were Antibiotics (21.28%) followed by analgesics (12.77%), DMARD (12.77%), antihypertensive (12.77%), and others shown in the study. The severity assessment of ADRs was done by Modified Hartwig et al. severity assessment scale and was found mild (87%), followed by moderate (8.5%) and severe (4.3%). Using the modified Schumock and Thronton preventability scale preventability assessment of ADRs was done and was found 51.06% of ADRs were definitely preventable, 38.30% were probably preventable and 12.77% of ADRs were not preventable. Conclusion: The findings of this study emphasize the significance of pharmacovigilance and the requirement that medical personnel be knowledgeable about the indications and symptoms of ADRs.
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Mujer de 85 años con múltiples comorbilidades: enfermedad pulmonar obstructiva crónica (EPOC) y fallo cardíacao. Fue hospitalizada el mes previo por tromboembolismo pulmonar (TEP) manejado con rivaroxabán 20 mg/día; delirium mixto y demencia en tratamiento con risperidona inicialmente 0,5 mg/día y luego 1 mg/día al egreso. Reingreso hospitalario por choque séptico urinario por Klebsiella pneumoniae (KPC), tratado con ceftazidima/avibactam 2,5 g c/8 horas. Cuadro hemático (CH) de ingreso con 770 leucocitos/mm3, hemoglobina 6,3 g/dL, hematocrito 18,9% y plaquetas 61 000/mm3. Se suspende risperidona e inicia haloperidol; además se le transfunden 2 unidades de glóbulos rojos, y presenta mejoría al cuarto día. En el día 11 de hospitalización el CH muestra leucocitos 1840/mm3, neutrófilos 740/mm3, hemoglobina 9,8 g/dL, hematocrito 29,3% y plaquetas 227 000/mm3. La causalidad de la reacción adversa al medicamento (RAM) evaluada con algoritmo de la Organización Mundial de la Salud (OMS) fue clasificada como "posible". Es relevante tener un elevado índice de sospecha sobre los efectos adversos de los medicamentos en los pacientes y su relevancia clínica desde la perspectiva del personal sanitario, aplicando una farmacovigilancia activa, principalmente en el manejo del paciente con polifarmacia. (AU)
85-year-old woman with multiple comorbidities: Chronic Obstructive Pulmonary Disease (COPD) and heart failure. Hospitalization one month ago for pulmonary embolism (PE) managed with rivaroxaban 20 mg/day; mixed delirium and dementia treated with risperidone initially 0.5 mg/day and then 1 mg/day upon discharge. Rehospitalized for urinary septic shock caused by Klebsiella pneumoniae (KPC), treated with ceftazidime/avibactam 2.5 g every 8 hours. Admission blood count (CBC) showed 770 leukocytes/mm³, hemoglobin 6.3 g/dl, hematocrit 18.9%, and platelets 61,000/mm³. We suspended risperidone and started haloperidol, 2 units of red blood cells were transfused, showing improvement on the fourth day; CBC showed leukocytes 1,840/mm³, neutrophils 740/mm³, hemoglobin 9.8 g/dl, hematocrit 29.3%, and platelets 227,000/mm³. The causality of the adverse drug reaction (ADR) evaluated with the World Health Organization (WHO) algorithm ranked as "possible." It is relevant to have a high index of suspicion about the adverse effects of drugs in patients and their clinical relevance from the perspective of healthcare personnel, applying active pharmacovigilance, mainly in the management of patients with polypharmacy. (AU)
Subject(s)
Humans , Female , Aged, 80 and over , Pancytopenia/etiology , Pancytopenia/chemically induced , Acyclovir/toxicity , Risperidone/toxicity , Drug-Related Side Effects and Adverse Reactions/diagnosis , Pancytopenia/blood , Shock, Septic/diagnosis , Klebsiella Infections/etiology , Acyclovir/pharmacology , Risperidone/pharmacology , Polypharmacy , Drug Interactions , Leukopenia/bloodABSTRACT
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.
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Background: Chronic obstructive pulmonary disease (COPD) is one of the major causes of death around the world. Early initiation of treatment can reduce disease progression and mortality. COPD cannot be treated with monotherapy and requires multidrug therapy. The present study planned to evaluate the drug utilization pattern in the COPD patients. Aim and Objective: The aim of the study was to evaluate the common drug used in COPD patients. Second objective is to evaluate the safety of drugs. Materials and Methods: This study was conducted in the Department of Pharmacology, Sree Mookambika Institute of Medical Sciences during the period of January 2017–2018. According to study protocol, a total of 150 patients were included in the study. All the patient demographic, clinical, and medication details were collected and analyzed. Results: Totally 150 COPD patients were analyzed. Among 85 were male and 65 were female. The mean age of the study population is 58.28. 4.33 is the average number of drugs prescribed per patient in that beta-2 agonists are most common compared to other drugs. Patients are developed adverse drug reaction that was analyzed with WHO causality assessment. Conclusion: The study results concluded that most of the patients were taking beta-2 agonists.
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Background: One of the main causes of morbidity is psychiatric disorders, which are becoming a burden to public health. The therapeutic choices are influenced by several factors, including treatment paradigms, safety, and costs that determine outcomes. Aim: We carried out the drug utilization evaluation (DUE) of antidepressants in patients visiting the psychiatry outpatient department. Study Design: An observational, prospective, and cross-sectional study. Place and Duration of Study: Department of Psychiatry, Jaya Krishna Hospital, Hanamkonda, TS, between September 2021 to April 2022. Methodology: We included patients who visited the psychiatric outpatient hospital, were clinically diagnosed, and received any antidepressants for the long term. The relevant data collected from the information resources was systematically analyzed for DUE. Results: Among 417 patients, the majority were in the age group of 31-40 (33.3%) years, and the most affected were female (57.3%), married (73.4%), and housewives (29.5%). Depression (37.6%) was the most commonly diagnosed psychiatric disorder. Of these prescriptions, 5.3% were monotherapy, the remaining was polytherapy (94.7%), and the majority of them had three drugs (36.2%). The average number of drugs per encounter was 3.4, drugs prescribed by generic names were 41.4%, injectable drugs prescribed were 2.6%, and drugs listed in the National List of Essential Medicines were 61.3%. Of all, 88.7% of prescriptions had at least one antidepressant, predominantly SSRIs, and fluoxetine (23.0%) was the most commonly prescribed. Benzodiazepines (59.7%) were the most frequently prescribed concomitant drug class and clonazepam (50.6%) was the most widely prescribed. Suicidal thoughts (5.8%) were the most commonly observed ADR. Conclusion: The study observed a pattern of polytherapy, mainly antidepressants from the SSRIs, notably fluoxetine mostly prescribed, and suicidal thoughts were the frequent ADR. Drug use surveillance studies, rationalizing therapeutic choices, and proper patient counseling would improve therapeutic outcomes by minimizing side effects and ADRs.
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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.
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Background: Ensuring the safety of pharmaceutical products, including drugs, vaccines, and biologicals, is essential to safeguard public health by guaranteeing their efficacy and security. Unfortunately, medication-related errors combined with imprudent medication practices frequently lead to significant repercussions for global health-care systems. Aims and Objectives: This study was undertaken to evaluate the comprehension, perspective, and conduct of postgraduate students and doctors regarding pharmacovigilance, as well as to identify barriers hindering the reporting of adverse drug reactions (ADRs) within tertiary care hospitals associated with the Government Medical College in Jalgaon. Materials and Methods: A descriptive cross-sectional research endeavor took place within the tertiary care hospitals associated with the Government Medical College in Jalgaon. This study planned from June 2018 to March 2021 and involved registered doctors employed in tertiary care hospitals and postgraduates. Throughout this duration, a total of 220 eligible participants who met the inclusion criteria and consented to be part of the study successfully filled out and submitted the validated structured questionnaires. Results: The results showed that the overall level of knowledge and attitude toward pharmacovigilance was good, with a mean score of 7.41 ± 1.05 out of 10 for knowledge and 4.02 ± 0.61 out of five for attitude. However, the level of practice was poor, with only 36.4% of participants reporting that they had ever reported an adverse drug reaction. The study also found that postgraduate students had a better level of knowledge and attitude toward pharmacovigilance compared to doctors. Conclusion: The study highlights the need for increased awareness and education on pharmacovigilance among health-care professionals, particularly in terms of reporting ADRs.
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Background: Adverse drug reactions are a major contributor to morbidity and hospitalization in patients and have been held responsible for as much as 5% of hospital admissions. This is especially relevant in cancer patients undergoing palliative care because they often suffer from advanced/terminal cancer and the adverse drug reactions from the palliative care drugs can affect their remaining quality of life. Aim and Objectives: The aim of this study was to study the adverse drug reaction profile of palliative drugs used in cancer patients undergoing palliative care at the Pain and Palliative Care OPD and their association with gender, age, dose, and duration of opioid intake. Materials and Methods: After receiving permission from the Institutional Ethics Committee, TDMC Alappuzha, 138 eligible cancer patients receiving palliative care from the pain and palliative care OPD were included in the study. The necessary data were obtained through interviews with the patients, who had given their consent to the study and the information was used to fill a questionnaire. Results: Out of the 138 study participants, 96 were male and 42 were female. The age composition ranged from 35 years to 88 years of age. There were 30 diabetic patients, 28 hypertensive patients, and 13 patients with CAD. The most frequent adverse effects, seen within 2 weeks of a 5 mg dose oral morphine regimen, were nausea (58.26%), constipation (51.18%), vomiting (43.30%), insomnia (33.07%), sedation (31.49%), dry mouth (25.19%), abdominal discomfort (24.04%), edema (20.47%) and tremors (19.68%). Using the modified Naranjo algorithm, 12% of ADRs were doubtful, 40% of ADRs were possible, 32% of ADRs were probable, and 16% of ADRs were definite. Among male patients taking 5 mg oral morphine, the most frequent ADRs were nausea (56.25%), constipation (45.31%), vomiting (40.62%), insomnia (34.37%), sedation (26.56%), dry mouth (21.87%), abdominal discomfort (18.75%), and edema (17.18%). Among female patients, the most frequent ADRs were vomiting (58.62%), nausea (55.17%), constipation (55.17%), abdominal discomfort (34.48%), dry mouth (31.03%), insomnia (31.03%), tremors (31.03%), sedation (24.13%), edema (20.68%), and pruritus (20.68%). Almost no significant associations were seen w.r.t to age, dose, and duration of opioid intake. Conclusion: The study identified the adverse effects associated with palliative care and their relative incidence. It also attempted to derive a correlation between the incidence of adverse effects and the age and gender of patient, the dose, and duration of opioid use.
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Background: Antimicrobial agents (AMAs) are the mainstay of treatment in modern medicine. In view of emerging threat of antimicrobial resistance, there is a requirement aimed at identifying patterns of antimicrobial prescribing. This study focuses on the prescribing pattern of AMAs and the incidence of adverse drug reaction (ADR) among the inpatients of Malabar Medical College and Hospital, Calicut. Aims and Objectives: The objectives of this study were to evaluate antibiotics prescribing pattern and ADR’s in a tertiary health-care center in Northern Kerala. Materials and Methods: This is a prospective and observational study for a period was 6 months between March 2022 and August 2022. A total of 500 enrolled patients were observed from admission till discharge. Medical case sheets, drug charts, and laboratory investigations were recorded in a self-designed standardized performa and analyzed. Results: Most of the patients were in the age group 51 to 60 (26%), followed by 61 to 70 (22%), followed by 71 to 80 (16%). Out of 500 patients assessed, 64% were males and 36% were females. Out of 100 prescriptions, 64% of the prescriptions were in the parenteral form, 30% oral, and the remaining in topical form. Out of 500 prescriptions, 83% used brand name while prescribing, while the remaining 13 % used generic name. The most commonly prescribed antibiotic was Cefoperazone-Sulbactem combination (16%) followed by Piparacillin, Tazobactam, and Azithromycin Combination. Out of 500 patients, 30 patients (6%) developed ADR. The most common ADRs seen with the study included hypersensitivity (44%), gastrointestinal upset (30%), and headaches (10%). Conclusion: From an analysis of 500 patients from six in-patient departments, it was found that hospital doctors prescribed antibiotics more logically, with fewer newer drugs and no banned ones. ADRs were seen in 6% of patients, which was comparatively higher compared to previous studies.
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A 68-year-old male patient with malignant left lung tumor was treated with gefitinib(250 mg,po,qd)for 29 days.Liver function test results showed AST 310 U·L-1,ALT 493 U·L-1,AKP 100 U·L-1,TBil 18 μmol·L-1,GGT 60 U·L-1,INR 1.81.Several liver function indicators of the patient showed abnormal,which was consistent with the clinical manifestations of moderate liver injury.The liver function index of the patient improved after the doctor adopted the suggestion of clinical pharmacists to protect the liver.Clinical pharmacists made a comprehensive and dynamic assessment of the patient's condition,analyzed the correlation between the patient's liver injury and gefitinib,and judged that the patient's liver injury was likely caused by gefitinib.Clinical pharmacists analyzed the drug use of a blind trial patient,proposed the follow-up treatment plan,and discussed the blind trial drugs,which provided references for clinical safe and rational drug use and had important reference significance.
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A 75-year-old female patient with gastric cancer received cadonilimab(500 mg,iv,d1)combined with albumin-bound paclitaxel(300 mg,iv,d2)and tegafur,gimeracil and oteracil potassium(40 mg,po,bid,d2-15)and 21 days was a cycle.Admission examination at the end of 4 cycles of treatment,laboratory tests showed adrenocorticotropic hormone＜1.00 pg,mL-1,cortisol 0.42 μg·dL-1 and serum sodium 131 mmol·L-1.Immune checkpoint inhibitor-related hypophysitis was diagnosed,and pituitary crisis was developed on the 4th day.The diagnosis of hypophysitis concurrent with pituitary crisis was considered to be related to cadonilimab.High-dose glucocorticoids replacement and symptomatic treatment such as rehydration to maintain electrolyte imbalance were given.On the 9th day after admission,the patient was basically in remission.The administration of cadonilimab may cause pituitary crisis,which is relatively rare in clinical practice.This case reminds that the possibility of hypophysitis when patients emerge with the symptom of fatigue and anorexia along with hyponatremia.Assessment of endocrine gland function,correct diagnosis and proper therapy are of significant clinical value to improve the patients'prognosis.
ABSTRACT
Objective To evaluate adverse events(AEs)of hematological toxicities in cyclin-dependent kinase 4/6(CDK4/6)inhibitors based on the FDA adverse event reporting system(FAERS)database,and to provide a reference for rational drug use in the clinic.Methods A total of 29 quarterly AEs were extracted from the FAERS database from January 2015 to March 2022.Reported odds ratio(ROR)and proportional reported ratio(PRR)were used for data mining of CDK4/6 inhibitor AEs.Results A total of 7 872 AEs related to CDK4/6 inhibitors were reported,and the proportion of hematological AEs of each inhibitor was palbociclib(80.31%),ribociclib(15.36%),and abemaciclib(4.33%).Neutropenia and anemia were common in hematological toxicities.Palbociclib(2 982/6 322,47.17%)and ribociclib(613/1 209,50.70%)caused more neutropenia than abemaciclib(117/341,34.31%).Hematological toxicities mainly occurred 60 days after drug initiation(1 630,61.86%).Palbociclib had the longest median onset time,and 32.9%of patients still had hematological toxicities after 90 days of treatment.The clinical features and intensity were different among CDK4/6 inhibitors.Conclusions Palbociclib,abemaciclib,and ribociclib all cause significant hematological toxicities,among which abemaciclib has fewest reports of hematological toxicities.Still,the risk of death after anemia caused by abemaciclib should be noted.Complete blood cell count should be closely monitored within the first two months after treatment to monitor the patient's neutrophils and hemoglobin.The occurrence of hematological AEs associated with CDK4/6 inhibitors should be noted in the clinic.