Importance Of Adverse Drug Reactions Research Articles

Frequency, Characteristics, and Preventability of Adverse Drug Reactions in Perioperative Neurosurgery: Analysis Over 11 Years

Frequency, Characteristics, and Preventability of Adverse Drug Reactions in Perioperative Neurosurgery: Analysis Over 11 Years

Exploring pharmacovigilance practices and knowledge among healthcare professionals: A cross-sectional multicenter study.

Healthcare professionals' awareness of adverse drug reaction reporting and pharmacovigilance practices differ by country. The study assesses healthcare professionals' knowledge, practice, and potential barriers to pharmacovigilance-related practices and reporting adverse drug reaction. A cross-sectional investigation was conducted in government and private healthcare settings. The study included licensed physicians, pharmacists, and nurses. To examine knowledge, practice, and potential barriers to pharmacovigilance-related practices and adverse drug reaction reporting, a 22-item validated questionnaire was used. The final analysis included 311 healthcare professionals. Most healthcare professionals, 59% (N = 182), mentioned encountering patients with adverse drug reactions during the last year. On the other hand, most healthcare professionals, 54% (n = 167), mentioned that they had not reported adverse drug reactions. A good proportion of respondents mentioned that it is essential to report adverse drug reactions (N = 288, 92.6%), availability of adverse drug reactions reporting forms in practice sites (N = 216, 69.5%), had awareness regarding how to report adverse drug reactions (N = 221, 71.1%), the necessity of reporting minor/less important adverse drug reactions (N = 265, 85.2%), and were trained on how to report adverse drug reactions (N = 201, 64.6%). Adverse drug reaction reporting program in the United Arab Emirates (N = 148, 47.6) was known to many healthcare professionals. Lack of time was the major impediment to reporting adverse drug reactions at 42.7% (N = 133). The predictor variable work experience does add to the model (p < 0.05) concerning association with filling of adverse drug reaction forms (Estimate = 0.380; SE = 0.452; p = 0.400), professional role (Estimate = 0.454; SE = 0.673; p = 0.500). In addition, the predictor variable practice setting adds to the model (p < 0.05) concerning the knowledge regarding the availability of adverse drug reaction reporting forms (Estimate = -1.229; SE = 0.298; p = 0.000), training on how to report adverse drug reactions (Estimate = -0.660; SE = 0.294; p = 0.025), and awareness regarding the adverse drug reaction reporting program in the United Arab Emirates (Estimate = -1.032; SE = 0.280; p = 0.000). Pharmacists had the most knowledge regarding adverse drug reaction reporting and pharmacovigilance. The underreporting of adverse drug reactions was documented among physicians and nurses. Lack of time was the most significant barrier to reporting adverse drug reactions, followed by uncertainty and complicated adverse drug reaction documentation forms.

Bullous pemphigoid associated with the use of DPP4 inhibitors: A case series

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.

Interstitial lung disease caused by niraparib in ovarian cancer patient: a case report and literature review.

Drug-induced interstitial lung disease (DIILD) is one of the most common and important adverse drug reactions. Still, the details of the clinical presentation of DIILD caused by poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitors are unknown. A 73-year-old Japanese woman was started on niraparib maintenance therapy after radical surgery and adjuvant chemotherapy for high-grade serous carcinoma originating from the fallopian tube. Forty-seven days after starting niraparib, she presented to the hospital with dyspnea and was diagnosed with DIILD caused by niraparib. The drug was discontinued, and the patient was treated with steroid pulse therapy, and her condition improved. In clinical trials of PARP inhibitors, DIILD was reported in 0.13% of patients with olaparib, but no DIILDs, including pneumonia or pneumonitis, were reported in any patient with niraparib. This is the first report of DIILD caused by niraparib worldwide. In the future, the frequency of DIILD caused by niraparib should be clarified in real-world data.

An expert review of clozapine in Latin American countries: Use, monitoring, and pharmacovigilance

There is growing interest in clozapine clinical use, monitoring, and research, particularly adverse drug reactions (ADRs) other than agranulocytosis. In this study we focused on clozapine pharmacovigilance. Hence, we contacted clinicians and researchers in Latin America and requested information about local psychiatric services, clozapine availability, clinical use, and ADR monitoring with the VigiBase system. Only two countries have the minimum recommended number of psychiatric beds (15 per 100,000 residents): Uruguay (N = 34.9) and Argentina (N = 17). Bolivia is the only country where clozapine is unavailable. Nine out of twenty countries (45 %) reported ADRs to VigiBase. Argentina, Brazil, Chile, Colombia, and Mexico published national guidelines for schizophrenia treatment. Chile is the sole country with clozapine clinics with drug serum monitoring. Ethnicity-related drug titration in not described in package inserts in any country. We examined in detail the 9 most frequent and important clozapine ADRs in the worldwide database (pneumonia, sudden death, cardiac arrest, agranulocytosis, myocarditis, constipation, arrhythmia, seizure, and syncope). These 9 ADRs led to 294 reports with fatal outcomes in Argentina (N = 3), Brazil (N = 3), Chile (N = 2), and Peru (N = 1). Agranulocytosis was reported from 7 countries: constipation or seizures from 8 countries. Only two countries reported pneumonia and one country reported myocarditis. The number of clozapine reports in VigiBase has no relationship to the country's population. All Latin American countries underreport clozapine associated ADRs. Latin American governments, along with clinicians, researchers, and educators, should optimize clozapine use and monitoring for the benefit of people with severe mental and some neurological disorders.

Validation of 3- and 5-point severity scales to assess ARIA-E.

Anti-amyloid-β (Aβ) monoclonal antibodies (mAbs) offer the promise of disease modification and are emerging treatment options in Alzheimer's disease. Anti-Aβ mAbs require brain magnetic resonance imaging (MRI) examinations to detect anti-amyloid-induced amyloid-related imaging abnormalities (ARIA), important adverse drug reactions associated with some anti-Aβ mAbs currently available in the United States and in clinical development. We present a simple rating system for ARIA-edema (ARIA-E) that can assess severity on a 3- or 5-point scale based upon a single linear measurement of the largest area of lesion, and dissemination in space, termed the 3-point Severity Scale of ARIA-E (SSAE-3) and the 5-point Severity Scale of ARIA-E (SSAE-5), respectively. MRI results were collected from 75 participants from the SCarlet RoAD (NCT01224106) and Marguerite RoAD (NCT02051608) studies of gantenerumab. Three neuroradiologists experienced with the detection of ARIA-E were selected to read all cases independently. One rater was then chosen for a second read to assess intra-reader reproducibility. The three raters had high agreement in identifying and grading ARIA-E. The Cohen/Fleiss kappa (κ) scores (95% confidence interval [CI]) for the inter- and intra-reader comparisons for SSAE-3 and SSAE-5 were 0.79 (0.70-1.00), 0.94 (0.94-1.00), 0.73 (0.66-1.00), and 0.90 (0.90-1.00), respectively. Our study suggests that SSAE-3 and SSAE-5 are valid ARIA-E rating scales for use in routine clinical practice by experienced radiologists in specialized settings. The application of these scales in everyday use in clinical practice will support the expansion of anti-Aβ mAbs as a treatment option for people living with Alzheimer's disease. A simple rating scale is needed to rate severity of amyloid-related imaging abnormalities-edema (ARIA-E) in both research and clinical settings.The 3- and 5-point Severity Scales of ARIA-E (SSAE-3/-5) have good inter- and intra-reader agreement.The SSAE-3/-5 have been used in most major Alzheimer's disease (AD) trials to date and are suitable for large-scale use in routine clinical practice, which may help support the expansion of anti-amyloid antibodies as treatment options for AD.

Chinese guideline for diagnosis and management of drug-induced liver injury (2023 version)

Drug-induced liver injury (DILI) is an important adverse drug reaction that can lead to acute liver failure or even death in severe cases. Currently, the diagnosis of DILI still follows the strategy of exclusion. Therefore, a detailed history taking and a thorough and careful exclusion of other potential causes of liver injury is the key to correct diagnosis. This guideline was developed based on evidence-based medicine provided by the latest research advances and aims to provide professional guidance to clinicians on how to identify suspected DILI timely and standardize the diagnosis and management in clinical practice. Based on the clinical settings in China, the guideline also specifically focused on DILI in chronic liver disease, drug-induced viral hepatitis reactivation, common causing agents of DILI (herbal and dietary supplements, anti-tuberculosis drugs, anti-neoplastic drugs), and signal and assessment of DILI in clinical trials.

Temporal presentations of heparin‐induced thrombocytopenia following cardiac surgery: A single‐center, retrospective cohort study

BackgroundHeparin‐induced thrombocytopenia (HIT) is an important adverse drug reaction that can occur postcardiac surgery. Preoperative exposure to unfractionated heparin (UFH) is common, raising the issue of how frequently cardiac surgery‐associated HIT occurs after immunizing preoperative exposure to heparin. ObjectiveTo determine the frequency and clinical picture of HIT occurring within 4 days of cardiac surgery (early presentation) versus later presentations (typical, delayed). MethodsWe identified patients with laboratory‐confirmed HIT following cardiac surgery over 30 years in a single cardiac surgery center. Three different clinical presentations of HIT were identified: typical (HIT‐related platelet count fall beginning between postoperative days [PODs] 5–10), delayed (patients with falls after POD10 or who presented following hospital discharge), and early (established before POD5, including during cardiac surgery [acute intraoperative HIT]). ResultsOf 129 patients identified with HIT complicating cardiac surgery, 100 had typical and 16 had delayed presentation of HIT; only 13 patients (10.1%) presented with early HIT, all of whom had received exposure to UFH during the 10 days before cardiac surgery. No patient was identified in whom remote preoperative UFH exposure was implicated in explaining early HIT. Notably, five patients appeared to have had acute intraoperative HIT, without immediate adverse consequences. ConclusionsApproximately 90% of patients with HIT after cardiac surgery appear to develop this complication due to immunization triggered by cardiac surgery; however, in approximately 10% of patients, early presentation during the first four PODs (or intraoperatively) can be explained by recent immunizing exposure to heparin.

Vonoprazan-associated nephrotoxicity: extensive real-world evidence from spontaneous adverse drug reaction reports

Vonoprazan-associated nephrotoxicity: extensive real-world evidence from spontaneous adverse drug reaction reports

Safety profile of hydroxychloroquine used off-label for the treatment of patients with COVID-19: A descriptive study based on EudraVigilance data.

At the beginning of the COVID‐19 pandemic, worldwide attempts were made to identify potential drugs effective against the COVID‐19. Hydroxychloroquine was among the first receiving attention. However, following its use in therapy, it has been shown that hydroxychloroquine was not only ineffective but probably, due to its known side effects, even responsible of increased mortality of patients. The objective of this study was to review the safety profile of hydroxychloroquine used off‐label for the treatment of COVID‐19. We analyze the reports of suspected adverse drug reactions (ADRs) collected in EudraVigilance, the European database of ADR reports. We collected 2266 reports for 2019 and 6525 for 2020. The most reported ADRs during 2020 were those relating to cardiac, hepatic, renal toxicity such as QT prolongation with 400 cases in 2020 (of which, 345 cases—9.97%—with COVID‐19 as a therapeutic indication) versus 1 case only in 2019 (0.01%), long QT syndrome: 38 cases in 2020 (36 as COVID‐19 treatment) versus 0 in 2019, hepatitis: 13 cases in 2019 (0.11%) and 132 in 2020, and 32 cases (24, 0.69%) of acute kidney injury in 2020 and only 3 cases in 2019. Moreover, some important vision‐related ADRs also increased significantly during 2020, such as retinal toxicity with 92 cases in 2020 versus 7 in 2019. Even though with its intrinsic limitations, our results may be added to the most recent scientific evidence to confirm the unfavorable risk profile of hydroxychloroquine in its off‐label use in the treatment of COVID‐19 disease.

Evaluation of Drug-Related Problems in Chronic Kidney Disease Patients.

BackgroundChronic kidney disease (CKD) is a challenging global health problem with increasing prevalence worldwide. Concurrence of CKD and comorbidities results in the use of multiple medications and exposing patients to polypharmacy. Polypharmacy in CKD is common across all the stages of the disease and leads to poor medication adherence, higher healthcare costs, and drug-related problems, such as drug-drug interactions (DDIs) and adverse drug reactions (ADRs). DDIs and ADRs in CKD patients may lower the quality of life, increase the length of hospital stay, and augment the risks of morbidity and mortality.MethodologyThis was a hospital-based, prospective, cross-sectional study conducted in a secondary care hospital. The study population comprised 130 adult CKD patients admitted to the nephrology department including those on maintenance hemodialysis. Study-related data were obtained from the electronic patient case records. Medications prescribed to the patients were analyzed for potential DDIs (pDDIs) using Portable Emergency and Primary Care Information Database (PEPID 12.1) drug interaction checker. All observed and reported suspected ADRs related to the prescribed drugs were evaluated for causality, severity, preventability, and predictability.ResultsOut of the 130 patients, majority were males (n = 71, 54.6%), in the age group of 61-70 years (n = 45, 34.6%), and belonged to CKD stage 5 (n = 105, 80.8%). The mean number of drugs prescribed was 11.1 ± 3.8 per patient. The prevalence of pDDIs was found to be 89.2%. Upon analysis by the PEPID database, 708 pDDIs with 215 different pairs of interacting drugs were identified. Polypharmacy (odds ratio (OR): 62.34, 95% confidence interval (CI): 7.97-487.64, p < 0.001) was identified as an independent predictor of the occurrence of pDDIs. Negative binomial regression analysis revealed that dyslipidemia (incidence rate ratio (IRR): 2.7, 95% CI 2.09-3.48, p < 0.001) and diabetes (IRR: 1.2, 95% CI 1.01-1.54, p = 0.040) increased the probability of occurrence of pDDI by 2.7 and 1.2 folds, respectively. Furthermore, the likelihood of pDDI increased with every one-day increase in the length of hospital stay (IRR: 1.02, 95% CI 1.00-1.03, p = 0.015) by 1.02 times and polypharmacy (IRR: 6.30, 95% CI 3.04-13.02, p < 0.001) by 6.3 times. The incidence of ADRs was found to be 10.7%. Majority of suspected ADRs were possible (n = 7, 50.0%), of mild and moderate severity (n = 7, 50.0%), and non-preventable (n = 8, 57.1%) type.ConclusionsThis study investigated two important drug-related problems, pDDIs, and ADRs, in the CKD population. High proportion of CKD patients in the study had pDDIs. Comorbid conditions such as dyslipidemia and diabetes mellitus, length of hospital stay, and polypharmacy were significantly associated with increased likelihood of pDDIs. Furthermore, there was a burden of ADRs in the study population, of which most ADRs were possible and of mild to moderate severity. Prevention, identification, and resolution of these problems in CKD patients is important and can be achieved through medication optimization, which requires a proactive interdisciplinary collaboration between clinicians, clinical pharmacists, and other healthcare professionals.

CONTRAST-INDUCED NEPHROPATHY: PREVALENCE, DIAGNOSIS, PREVENTION AND TREATMENT

Resume. Medical imaging has become an important diagnostic and therapeutic tool in clinical medicine in the era of great technological advances. One of the most frequent and important adverse drug reactions during angiographic studies is contrast-induced nephropathy. Study of epidemiology, risk factors for the development of contrast-induced nephropathy, possible ways of prevention and treatment to reduce the frequency and severity of this complication, improve the quality of patient therapy and reduce the cost of treating complications. Materials and methods. The search for information in the database PubMed, Scopus, Web of Science, e-library, etc. was carried out using the following words and phrases: percutaneous coronary intervention, coronary angiography, contrast-induced nephropathy. Results. The incidence of contrast-induced nephropathy during coronary angiography varies from 2 to 25 %, however, in high-risk groups it can reach 50 %. To prevent the development of contrast-induced nephropathy, there are a number of pharmacological and non-pharmacological approaches. Its prevention is most relevant in high-risk patients. Conclusions. Minimizing the volume of the radiopaque agent, preventing and correcting hypovolemia, preventing the activation of vasoconstriction are the most effective measures to prevent contrast-induced nephropathy.

High-dose gatifloxacin-based shorter treatment regimens for MDR/RR-TB

SettingThe shorter treatment regimen (STR) for multidrug- or rifampicin-resistant tuberculosis (MDR/RR-TB) has achieved successful outcomes in many countries. However, there are few studies on high-dose gatifloxacin-based STR with adverse drug reactions (ADRs) and management. DesignA prospective observational study was conducted with MDR/RR-TB patients who were treated with a standardized 9 or 12 - month regimen: including gatifloxacin (Gfx), clofazimine (Cfz), ethambutol (EMB), and pyrazinamide (PZA), and supplemented by amikacin (Am), isoniazid (INH), and prothionamide (Pto) during an intensive phase of 4 or 6 - month. Monitored ADRs monthly until treatment completion and then followed up every three months for one year. ResultsAmong the 42 eligible patients, 35 (83.3%) completed treatment successfully, 1 (2.4%) lost to follow-up (LTFU), and 6 (14.3%) failed due to ADRs, with no death. The most important ADR was drug-induced liver damage, which occurred in 24 out of 42 (57.1%) patients and resulted in 4 (9.5%) failed treatments and 4 (9.5%) adjusted treatments. QT interval prolongation occurred in 17 out of 42 (40.5%) patients, 9 (21.4%) of them with the corrected QT interval according to Fridericia (QTcF) > 500 ms resulting in 7 (16.7%) adjusted treatments. ConclusionsThis study confirmed the effectiveness of the high-dose gatifloxacin-based STR but severe ADRs, especially hepatotoxicity and QT interval prolongation should never be ignored.

Survery of healthcare professionals to assess the awareness, knowledge and self-reported behavior regarding recent fluoroquinolones safety issues.

The impact of fluoroquinolone (FQ)-induced long-lasting, disabling, and potentially irreversible serious adverse drug reactions (ADRs) on the overall benefit-risk balance and the need for adequate risk minimization measures has been recently assessed. The present study aims to evaluate physicians and pharmacists' awareness and knowledge of the recent safety issues communicated through a direct healthcare professional communication (DHPC), regarding FQs, at a national level, in Romania, as well as healthcare professionals (HPs) self-reported behavior regarding the management of the risk. Cross-sectional, online survey study, conducted in Romania. A total of 127 participants responded to the survey. Six (4.7%) were physicians and 121 (95.3%) were pharmacists. The predominant age was 31-40 years (N=52, 40.9%), and most respondents were females (N=117, 92.1%). A majority of 101 (79.5%) were reportedly aware of the existence of the new safety issues associated with FQs, and slightly less were aware of the DHPC (N=86, 67.7%) issued in 2019. In terms of knowledge, slightly more than half of the respondents had correctly selected the responses regarding key safety messages on most important ADRs and restrictions / cautions for use. The impact of the communication on HPs self-reported behavior was high or very high in almost half of the participants (N=63, 49.6%). A high percentage of participants were aware of the FQ-associated safety concerns. Knowledge was relatively good for the key safety concerns among HPs. A notable impact on behavior was observed, mostly in terms of counselling of the patient and disseminating the information to colleagues.

Validity of hospital ICD-10-GM codes to identify anaphylaxis.

Anaphylaxis (ANA) is an important adverse drug reaction. We examined positive predictive values (PPV) and other test characteristics of ICD-10-GM code algorithms for detecting ANA as used in a multinational safety study (PASS). We performed a cross-sectional study on routine data from a German academic hospital (2004-2019, age ≥ 18). Chart review was used for case verification. Potential cases were identified from the hospital administration system. The main outcome required at least one of the following: any type of specific in-hospital code (T78.2, T88.6, and T80.5) OR specific outpatient code in combination with a symptom code OR in-hospital non-specific code (T78.4, T88.7, and Y57.9) in combination with two symptom codes. PPV were calculated with 95% confidence interval. Sensitivity analyses modified type of codes, unit of analysis, verification criteria and time period. The most specific algorithm used only primary codes for ANA (numbers added in brackets). Four hundred and sixteen eligible cases were evaluated, and 78 (37) potential ANA cases were identified. PPV were 62.8% (95% CI 51.1-73.5) (main) and 77.4% (58.9-90.4) (most specific). PPV from all modifications ranged from 12.9% to 80.6%. The sensitivity of the main algorithm was 66.2%, specificity 91.5%, and negative predictive value 92.6%. Corresponding figures for the most specific algorithm were 32.4%, 98.0%, and 87.0%. The PPV of the main algorithm seems of acceptable validity for use in comparative safety research but will underestimate absolute risks by about a third. Restriction to primary discharge codes markedly improves PPV to the expense of reducing sensitivity.

Reporting, handling, and subjective importance of adverse drug reactions among general practitioners: an exploratory cross-sectional survey

ABSTRACT Background: Interventions for improving reporting and management of adverse drug reactions (ADRs) need regular evaluations of attitude and knowledge of health care professionals regarding pharmacovigilance. Research design and methods: An exploratory survey among general practitioners in Germany was conducted. Results: We interviewed 302 individuals (participation rate 34.3%; mean age 54 yrs; 37.1% female). Underreporting was prevalent in the sample (only 16.6% had reported an ADR in 2015; average total number of ADR-reports was 5). We found awareness of the importance of pharmacovigilance and ADRs, information deficits (43% were not aware of the obligation to report ADRs), and several uncertainties regarding the detection and reporting of ADRs. The participants rated the German ADR reporting system as satisfactory (mean grade 3.7 ± 1.2) and criticized the expenditure of time (63.6%) and the overall complexity (47.4%). To increase the motivation to report ADRs, the majority requested the possibility to report by telephone (61.3%), feedback after reporting (49.3%), telephone consultations (47.4%), and more education and training in pharmacovigilance (31.1%), also during medical school (25.8%). Conclusions: We found evidence of objective and subjective need for further (mandatory) education and training in pharmacovigilance, already during medical school. Our results point to some shortcomings of the German pharmacovigilance system.

Assessment of suspected adverse drug reactions in elderly patients with diabetes mellitus based on a Portuguese spontaneous reporting database: analysis of reporting from 2008 to 2018

ABSTRACT Background Age is one of the most important risk factors in the development of diabetes mellitus and certain drug classes indicated for this condition may be associated with clinically important adverse drug reactions (ADRs). The aim of this study was to analyze the suspected ADRs in older patients with diabetes mellitus, reported to the Portuguese Pharmacovigilance System from 2008 to 2018. Research design and methods A retrospective analysis of suspected ADRs reports was performed, involving patients aged ≥65 years. Results Of a total of 751 reports collected, 439 were considered serious, 199 led to hospitalization and in 19 of them occurred a fatal outcome. Most of them were observed in females (n = 393) and involved patients belonging mainly to the age group 65–74 years (n = 405). Taking into account a total of 2134 suspected ADRs, the most frequent were hypoglycemia (2.67%) and lactic acidosis (2.62%). The drugs specifically indicated for glycemic control were the most frequently involved in ADRs. Conclusions Most of the ADRs were reported as serious and were mainly associated to drugs in diabetes mellitus. In addition, the majority of them, such as hypoglycemia, are preventable, highlighting the importance to identify possible factors that determine this occurrence, especially in the elderly.

Assessment of adverse drug reactions of psychopharmacological drugs in patients of psychiatric disorders

Introduction: Psychopharmacological drugs are used in the treatment of different types of psychotropic disorders. These drugs are associated with a variety of adverse drug reactions (ADRs). The ADRs due to psychopharmacological drugs are a significant cause of mortality and morbidity.&#x0D; Objectives: The current study assessed the adverse drug reactions of psychopharmacological drugs in patients with psychiatric disorders.&#x0D; Methods: This study was a retrospective study. All ADR forms related to psychopharmacological drugs that were reported to the pharmacovigilance center, UCMS, and GTB Hospital, between December 2019 to February 2020, were assessed to identify the incidence and nature of important ADRs. Causality assessment was done by WHO Uppsala Monitoring Centre Global Introspection Method. A total of 150 ADR forms were analyzed.&#x0D; Results: Females (60.66 %) experienced more ADRs than males (39.33 %). ADRs were most commonly reported in the age group of 18-28 years followed by 29-39 years. Depression was the most common diagnosis in patients with psychiatric disorders. Dizziness was the most common ADR followed by headache and insomnia. Escitalopram (12.21 %) was the most commonly implicated drug causing ADRs followed by clonazepam (9.92 %). As per the WHO causality assessment method, 77 % of ADRs were possible and 23 % were probable.&#x0D; Conclusions: Therefore, early detection and awareness of ADRs are important to enable health professionals to perform alterations in the prescribed drug treatment to prevent or reduce the adverse effects due to psychotropic drugs. This will improve patient care and safety as well as promote rational use of drugs.

The development of a scoring and ranking strategy for a patient-tailored adverse drug reaction prediction in polypharmacy

Only few applications are currently dealing with personalized adverse drug reactions (ADRs) prediction in case of polypharmacy. The study aimed to develop a patient-tailored ADR web application, considering characteristics from 734 drugs and relevant patient related factors. The application was designed in Python using a scoring and ranking system based on frequency and severity, computed for each ADR and expressed through an online platform. A neural networks algorithm was used for predicting the severity of ADRs. The application inputs are: age, gender, drugs, relevant pathologies. The outputs are: an overall severity profile (hospitalization and mortality risk), a stratified risk on specific ADR groups and a sorted list of the most important ADRs depending on frequency and severity. The Severity prediction model validation resulted in 79.7–85.1% Area Under the Receiver Operating Characteristic Curve Score, which lies in the good cut-off of 75–90%. The program offers a complex view regarding the ADR profile of a given patient and could be used by the physician and clinical pharmacist during patient safety monitoring, for a coherent therapy choice or medication adjustment, due to the good therapy coverage and the inclusion of relevant patient comorbidities.

Heparin-induced Thrombocytopenia: Pathophysiology, Diagnosis and Management.

Heparin-induced thrombocytopenia (HIT), even rare, is a life-threatening, immune-mediated complication of heparin exposure. It is considered the most severe non-bleeding adverse reaction of heparin treatment and one of the most important adverse drug reactions. The pathophysiological basis of HIT results from the formation of an immunocomplex consisting of an auto-antibody against platelet factor 4 (PF4) - heparin complex, which binds to the surface of platelets and monocytes, provoking their activation by cross-linking FcgIIA receptors. Platelets and monocyte activation, leads to the generation of catastrophic arterial and venous thrombosis, with a mortality rate of 20%, without early recognition. The definitive diagnosis of HIT i.e., clinical and laboratory evidence, can not be done at the onset of symptoms because laboratory results may not be available for several days. Thus, the initial approach is to predict the likelihood of HIT, because in highly suspected patients immediate heparin cessation and initiation of alternative anticoagulation treatment are crucial for the prevention of the devastating thrombotic sequelae. Herein, we describe the pathophysiology, the clinical manifestations, the diagnostic approach, and the management of patients with HIT.