Characteristics Of Adverse Drug Reactions Research Articles

A Retrospective Observational Study of Adverse Drug Reactions (ADR) Reported to ADR Monitoring Centre from 2010 to 2020.

Adverse Drug Reactions (ADR) are one of the essential causes of hospital admissions and pose a significant clinical and economic burden on the healthcare system. The Adverse Drug Reaction Monitoring Centre (AMC) in JIPMER functioning under the Pharmacovigilance Programme of India (PvPI) plays a vital role in ensuring medication safety by routinely detecting and monitoring ADRs. Hence, this study aimed to assess the characteristics of ADR reported from 2010 to 2020 in AMC JIPMER and to detect signals, if any. To study the characteristics of Adverse Drug Reactions (ADR) reported to a regional ADR monitoring center from 2010 to 2020 and to detect signals of disproportionate reporting (SDRs) if any from the reported ADRs. A total of 6007 ADR reports with a single suspect drug were included for analysis from 2010 to 2020. The characteristics of these reports, including patient's age and gender, Number and percentage of ADRs, the causality of ADR using WHO UMC (World Health Organization-Uppsala Monitoring Scale), the seriousness of the ADR, and outcome were collected from the ADR reports. MedDRA (Medical Dictionary for Regulatory Activities) Preferred Terms (PT) were used to classify adverse drug reactions. Causality analysis using the Naranjo Algorithm and Preventability using Modified Schumock and Thornton criteria were performed for the ADRs. The number and percentage of severe ADRs were analyzed. The System Organ class of all the ADRs was enumerated. ADRs not mentioned in the US FDA (United States Food and Drug Administration) product label (unlabelled reactions) were documented. Unlabeled reactions with ≥3 ADR reports were included for signal detection by disproportionality analysis. Antineoplastic drugs, followed by antimicrobials, anticonvulsants, Anti snake venom, and NSAID were the most common drugs implicated in ADRs. Skin and subcutaneous tissue disorders were the most common System Organ Class (SOC) involved in the ADRs. Among the 6007 reports, 19.2% were serious ADRs. Most of the ADR reports were of possible causality followed by probable and certain as per WHO UMC and Naranjo causality scales. Only ten ADRs were preventable and one reaction (Tamoxifen-induced neuropathy) was eligible for signal detection. Disproportionality analysis using a 2x2 contingency table showed insignificant signal detection using the Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR). Analysis of ADRs from an ADR Monitoring center functioning in a tertiary care hospital shows antineoplastic drugs to be the most common drugs associated with adverse drug reactions, with rash being the most common adverse effect. The majority of the ADRs were not preventable. No Signals of Disproportionate Reporting (SDR) were detected in our study.

DNA methylation inhibitors adverse reaction characteristic analysis: a descriptive analysis from WHO-VigiAccess.

DNA methylation inhibitors (azacitidine, decitabine) have revolutionized the treatment dilemma of myelodysplastic syndromes (MDS), a group of malignant hematopoietic disorders. This study evaluates the adverse drug reactions (ADRs) following the use of DNA methylation inhibitors in the World Health Organization (WHO) VigiAccess database and compares the characteristics of ADRs between the two drugs to select the drug with the minimum individualized risk for patients. This study employed a retrospective descriptive analysis method. We compiled ADR reports for two marketed DNA methylation inhibitors for the treatment of MDS from WHO-VigiAccess. Data collected included demographic data such as age groups, gender, and regions of global patients covered by ADR reports, as well as data on the disease systems and symptoms caused by ADRs recorded in the annual reports and reports received by WHO. By calculating the proportion of ADRs reported for each drug, we compared the similarities and differences in ADRs between the two drugs. Overall, 23,763 adverse events (AEs) related to the two DNA methylation inhibitors were reported in VigiAccess. The results showed that the top 10 most common AEs were febrile neutropenia, bone marrow suppression, neutropenia, anemia, pancytopenia, leukopenia, thrombocytopenia, bone marrow failure, agranulocytosis, and hematotoxicity. The top five common types of DNA methylation inhibitor AEs were blood and lymphatic system disorders (11,178 cases, 47.0%), cardiac organ diseases (1,488 cases, 6.3%), various congenital familial genetic diseases (49 cases, 0.2%), ear and labyrinth diseases (100, 4.2%), and endocrine system diseases (57, 2.4%). There is no Strong correlation between DNA methylation inhibitors and ADRs. Current comparative observational studies of these inhibitors show that there are common and specific adverse reactions in the ADR reports received by WHO for these drugs. Clinicians should improve the rational use of these drugs based on the characteristics of ADRs.

Cohort event monitoring of safety of COVID-19 vaccines: the Italian experience of the “ilmiovaccinoCOVID19 collaborating group”

Introduction: In 2021, the European Medicines Agency supported the “Covid Vaccine Monitor (CVM),” an active surveillance project spanning 13 European countries aimed at monitoring the safety of COVID-19 vaccines in general and special populations (i.e., pregnant/breastfeeding women, children/adolescents, immunocompromised people, and people with a history of allergies or previous SARS-CoV-2 infection). Italy participated in this project as a large multidisciplinary network called the “ilmiovaccinoCOVID19 collaborating group.”Methods: The study aimed to describe the experience of the Italian network “ilmiovaccinoCOVID19 collaborating group” in the CVM context from June 2021 to February 2023. Comprising about 30 partners, the network aimed to facilitate vaccinee recruitment. Participants completed baseline and follow-up questionnaires within 48 h from vaccination over a 6-month period. Analyses focused on those who completed both the baseline and the first follow-up questionnaire (Q1), exploring temporal trends, vaccination campaign correlation, and loss to follow-up. Characteristics of recruited vaccinees and vaccinee-reported adverse drug reactions (ADRs) were compared with passive surveillance data in Italy.Results: From June 2021 to November 2022, 22,384,663 first doses and 38,207,452 booster doses of COVID-19 vaccines were administered in Italy. Simultaneously, the study enrolled 1,229 and 2,707 participants for the first and booster doses, respectively. Of these, 829 and 1,879 vaccinees, respectively, completed both baseline and at least Q1 and were included in the analyses, with a significant proportion of them (57.8%/34.3%) belonging to special cohorts. Most vaccinees included in the analyses were women. Comirnaty® (69%) and Spikevax® (29%) were the most frequently administered vaccines. ADR rates following Comirnaty® and Spikevax® were higher after the second dose, particularly following Spikevax®. Serious ADRs were infrequent. Differences were observed in ADR characteristics between CVM and Italian passive surveillance.Conclusion: This study confirmed the favorable safety profile of COVID-19 vaccines, with findings consistent with pivotal clinical trials of COVID-19 vaccines, although different proportions of serious ADRs compared to spontaneous reporting were observed. Continuous evaluation through cohort event monitoring studies provides real-time insights crucial for regulatory responses. Strengthening infrastructure and implementing early monitoring strategies are essential to enhance vaccine safety assessment and prepare for future pandemics.

A real-world data analysis of ocular adverse events linked to anti-VEGF drugs: a WHO-VigiAccess study.

Vascular endothelial growth factor (VEGF) is key to wet age-related macular degeneration (wAMD). Anti-VEGF drugs are the main treatment in clinics. This study assessed ocular adverse events (AE) from anti-VEGF drugs in VigiAccess, WHO's database, and compared adverse drug reaction (ADR) profiles of four drugs to aid personalized treatment choices for optimal benefit and safety. The design was a descriptive retrospective study. We observed four anti-VEGF drugs commonly used in the clinical treatment of wAMD, and their ADR reports came from WHO-VigiAccess. The collected data included the age group, gender, and regional data, as well as the data of disease systems and symptoms caused by ADR recorded in the annual ADR reports and reports received by the WHO. We observed the overall characteristics of the ADR reports of these drugs, then explored the distribution of 27 SOCs of these drugs. Subsequently, we compared the most common ocular ADRs of the drugs. Finally, we compared the commonalities and differences of ocular ADRs related to the drugs. Overall, 57,779 AE associated with the four anti-VEGF drugs were reported. The results showed that the number of females experiencing ADRs (67.83%) was significantly higher than males (32.17%), the age group with the highest reported incidence was over 75years old. More than half of the ADR reports came from the Americas (50.86%). The five most common types of AE were: eye disorders (43.56%), general disorders and administration site conditions (34.47%), injury poisoning and procedural complications (13.36%), infections and infestations (11.61%), nervous system disorders (9.99%). Compared with the other three inhibitors, brolucizumab had a significantly higher rate of ocular ADR reports. The most common ocular ADRs of these four anti-VEGF drugs were mostly related to visual impairment, vision blurred, and blindness. However, there is still a disparity of ADRs between different drugs. The presence of ocular AEs when using anti-VEGF drugs to treat wAMD in clinical practice should attract clinical attention. Clinicians should use these expensive drugs more rationally based on the characteristics of ADRs and develop personalized treatment plans for patients.

Clinical analysis of adverse reactions in patients with multidrug-resistant and rifampicin-resistant pulmonary tuberculosis treated with delamanid-containing regimen

Objective: To explore the characteristics of adverse drug reactions during the 24-week therapy with delamanid-containing regimen for patients with multidrug-resistant and rifampicin-resistant pulmonary tuberculosis (MDR/RR-PTB). Methods: The prospective multicenter study was conducted from June 2020 to June 2023. A total of 608 eligible patients with MDR/RR-PTB were enrolled in 26 tuberculosis medical institutions in China including 364 males and 79 females, aged 39.6(19.0-68.0) years. Patients were treated with chemotherapy regimens containing delamanid. Patients were closely supervised during treatment of medication, and all adverse reactions occurring during treatment were monitored and recorded. The clinical characteristics of adverse reactions were evaluated by descriptive analysis. Chi-square test and multivariate logistic regression were used to analyze the related factors of QTcF interval prolongation (QT corrected with Fridericia's formula). Results: Of the 608 patients enrolled in this study, 325 patients (53.5%) reported 710 adverse events within 24 weeks of treatment. The top 6 most common complications were hematological abnormalities (143 patients, 23.5%), QT prolongation (114 patients, 18.8%), liver toxicity (85 patients, 14.0%), gastrointestinal reaction (41 patients, 6.7%), peripheral neuropathy (25 patients, 4.1%) and mental disorders (21 patients, 3.5%). The prolongation of QT interval mostly occurred in the 12th week after the first dose of medication. Serious adverse reactions occurred in 21 patients (3.5%). There were 7 patients (1.2%) with mental disorders, including 2 patients (0.3%) with severe mental disorders. Conclusions: The safety of dalamanid-based regimen in the staged treatment of MDR/RR-PTB patients was generally good, and the incidence of adverse reactions was similar to that reported in foreign studies. This study found that the incidence of QT interval prolongation in Chinese patients was higher than that reported overseas, suggesting that the monitoring of electrocardiogram should be strengthened when using drugs containing delamanid that may cause QT interval prolongation.

Adverse Drug Reactions: A Retrospective Analysis from the ADR Monitoring Centre at a Tertiary Care Hospital

Background: Adverse Drug Reactions (ADRs) present significant challenges in healthcare, necessitating vigilant monitoring and analysis to enhance medication safety protocols. This retrospective study aimed to analyse ADRs reported at an Adverse Drug Reactions Monitoring Centre (AMC) to understand prevalence, patterns, and characteristics of ADRs. Methods: Retrospective data from January to December 2023 were collected from the AMC at Vaishampayan Memorial Medical College, Solapur. A total of 282 ADR reports were analysed for frequency, severity, implicated medications, patient demographics, and associated clinical factors. Causality assessment was performed using the WHO- Uppsala Monitoring Centre scale. Results: The majority of ADRs were associated with the oral route of drug administration (79.43%), and most were categorized as minor severity (68.44%) and probable causality (91.84%). Common ADR symptoms included vomiting (9.55%) and rash (9.22%). Antimicrobial agents were the most suspected drugs causing ADRs (17.38%). The study revealed discrepancies in ADR reporting patterns and highlighted the importance of pharmacovigilance in capturing and addressing ADR occurrences. Conclusion: Our study provides valuable insights into the prevalence, patterns, and characteristics of ADRs, emphasizing the need for continued surveillance and reporting to promote patient safety and improve healthcare outcomes. Strategies to improve ADR reporting and enhance medication safety protocols are warranted to optimize patient care.

Characteristics of adverse drug reactions to N-acetylcysteine for paracetamol overdose in a tertiary Institution in Singapore

Characteristics of adverse drug reactions to N-acetylcysteine for paracetamol overdose in a tertiary Institution in Singapore

Pattern of Adverse Drug Reactions at a Tertiary Care Hospital, Kerala, India: A Cross-sectional Study

Introduction: With the rising use of medications, Adverse Drug Reactions (ADRs) have emerged as a significant public health issue. Therefore, establishing a robust pharmacovigilance system across the nation has become imperative. The present study focussed to analyse the trends and frequency of ADRs to enhance the safety of drug prescriptions and ensure public health protection. Aim: To assess the pattern of adverse effects, drugs implicated, causality, severity, and outcomes of ADRs reported to the ADR monitoring centre in the Department of Pharmacology, Government TD Medical College, Alappuzha, Kerala, India. Materials and Methods: This was a cross-sectional study in which 262 ADRs reported to the Department of Pharmacology, Government TD Medical College, Alappuzha, Kerala, India from May 2022 to April 2023 were analysed for patient demographics, drug and ADR characteristics, and the outcomes of the ADR. Causality and severity assessments of these ADRs were performed using the World Health Organisation (WHO)-Uppsala Monitoring Centre (UMC) scale and the modified Hartwig and Siegel’s scale, respectively. Data were tabulated using Microsoft Excel and expressed as mean, standard deviation, frequency, and percentage as appropriate, with the help of descriptive statistics using Epi Info 7 software. Results: A total of 262 ADRs were analysed. The mean age of the patients was 47.4±20.1 years. The majority were females 160 (61.1%). The intravenous route was the most common route involved in ADRs 158 (59.8%), followed by the oral route 91 (34.5%). Skin reactions accounted for more than half of the ADRs 151 (53.2%), followed by blood dyscrasias 48 (16.9%). Antibiotics were the most common group of implicated drugs 124 (44.9%), followed by anticancer drugs 43 (15.6%) and antitubercular drugs 34 (12.3%). Among antibiotics, cephalosporins (36.3%) were the most frequently encountered, followed by penicillins (30.6%). A total of 148 patients (56.5%) had recovered by the day of reporting, 146 (55.7%) ADRs were found to be ‘possible’ using the WHO-UMC causality scale, and 144 (54.9%) ADRs were classified as moderate severity. Conclusion: The study identified a widespread occurrence of ADRs, some of which increased healthcare costs due to prolonged hospital stays. The high incidence of ADRs from antimicrobials is concerning, as it contributes to antimicrobial resistance. This underscores the urgent need for prudent antimicrobial usage. The present study emphasises the importance of ADR reporting among healthcare workers and the necessity for hospitals to establish ADR reporting strategies for optimal patient care.

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

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

Characteristics of adverse drug reactions due to nonsteroidal anti-inflammatory drugs: a cross-sectional study.

Nonsteroidal anti-inflammatory drugs (NSAIDs) are widely used for treating pain and inflammation. Spontaneous adverse drug reaction (ADR) reports represent a rich data source for the detection of unknown and rare ADRs. This cross-sectional study aimed to analyze the characteristics of ADRs due to NSAIDs in Thailand. All ADR reports of NSAIDs for systemic use from 2015 to 2019 were extracted from the national database in Thailand. Patient characteristics, drug use information, adverse event information, and source of senders in 32,857 reports were analyzed. The annual number of ADR reports due to NSAIDs decreased from 7,008 in 2015 to 5,922 in 2019. The most frequently reported drug was ibuprofen (n=12,645, 38.5%) followed by diclofenac (n=7,795, 23.7%), most patients were 40-59 years old, and the major adverse reaction was angioedema (n=7,513, 22.9%). Serious reactions were recorded in 20.7% (n=6,801) of the total ADRs. Most patients (n=20,593, 62.7%) recovered without sequelae, but there were 5,420 patients (16.5%) who could not recover and 3,109 patients (9.5%) who were recovering. Eight patients (0.02%) died of Stevens-Johnson syndrome (n=3), toxic epidermal necrolysis (n=4), and anaphylactic shock (n=1), which were possibly related to ADRs. The number of ADR reports due to NSAIDs decreased from 2015 to 2019 in Thailand. Serious ADRs and death cases accounted for 20.7% and 0.02%, respectively. Most fatal cases exhibited severe drug-induced skin reactions.

Epidemiology of adverse drug reactions to antihypertensive, antithrombotic and antidiabetic medications among adult inpatients at a National Referral Hospital, Uganda

ABSTRACT Introduction Treatment for hypertension, thrombosis and type 2 diabetes mellitus is long term and usually requires a combination of drugs which increases the risk of adverse drug reactions (ADRs). This study aimed to establish the prevalence at admission, incidence during hospitalization and characteristics of ADRs linked to antihypertensive, antithrombotic and antidiabetic drugs among adult inpatients in Uganda. Methods We conducted a secondary analysis of data from a previously assembled prospective cohort study in Uganda’s Mulago National Referral Hospital. We reviewed the files of inpatients who received antihypertensive, antithrombotic and/or antidiabetic medications prior to and/or during hospitalization. The modified Schumock and Thornton Preventability Scale, the Division of AIDS Table for Grading the Severity of Adult and Paediatric Adverse Events and the World Health Organization – Uppsala Monitoring Centre seriousness criteria were used to characterize the ADRs. Results More than a quarter (27%, 42/155) of the inpatients experienced an ADR at admission or during hospitalization. The point prevalence of ADRs at admission was 8% (13/155) and the incidence of ADRs during hospitalization was 23% (36/155). Forty-one percent (35/86) of the ADRs were serious and the majority (59%, 51/86) were preventable. Conclusion One in 13 inpatients experienced an ADR on admission and one in four experienced an ADR that developed during hospitalization. Clinicians ought to prescribe medicines with lower ADR risk profile for cardiovascular and/or diabetic patients whenever possible.

Characteristics of adverse drug reactions induced by flutamide and bicalutamide: a real-world pharmacovigilance study using FAERS

ABSTRACT Background Flutamide and bicalutamide are indicated for the management of prostate metastatic carcinoma. The current study evaluated the adverse drug reactions related to flutamide and bicalutamide in a real-world setting. Methods To quantify the signals of flutamide and bicalutamide associated adverse events (AEs), we used the US Food and Drug Administration Adverse Event Reporting System (FAERS) for this pharmacovigilance study using established pharmacovigilance methods. Results A total of 2711 AEs of flutamide were investigated as the primary suspected; 522 AEs were related to prostate cancer. A total of 4459 AEs were investigated as the primary suspected for bicalutamide; 2251 AEs were related to prostate cancer. The analysis demonstrated 29 signals for flutamide and 84 for bicalutamide. Liver function test was the most common AEs for flutamide, and malignant neoplasm progression was the most common for bicalutamide. The signal strength of Dementia Alzheimer’s type was 26.53 (17.89–39.35) and 26.33 (607.34), which had the highest strength for flutamide. Anti-androgen withdrawal syndrome exhibited the strongest signal for bicalutamide. Generating awareness of rare AEs that were not listed on the label is critical. Conclusions The analysis of the AE signals may provide support for prescribing flutamide and bicalutamide.

Comparing patient reported and medical record data of adverse drug reactions to anti-seizure drugs.

Anti-seizure drugs (ASDs) can potentially cause serious adverse drug reactions (ADRs). Patient self-reporting can increase the rate of ADR detection, but studies examining patient self-reporting of ADRs caused by ASDs are lacking. To determine the characteristics of ADRs reported by patients receiving ASDs, assess laboratory data and medical record confirmation of patient-reported ADRs, and explore factors associated with laboratory data and medical record confirmation. A self-reporting questionnaire was distributed to patients prescribed ASDs at outpatient clinics. Patients assessed the causality of suspected ADRs using Causality Assessment Tool. Naranjo's algorithm was used by researchers for causality assessment. Medical records were used to gather information on ADR symptoms, ASD medication, and abnormal laboratory data. From 478 distributed questionnaires, 93.1% completed the questionnaire and 67.4% of respondents reported at least one ADR. The most common ADRs were drowsiness (50.7%), dizziness (9.7%), and ataxia (4.3%). For causality, suspected ADRs were classified as possible in 52.3% of cases and probable in 46.3% of cases by patients, and possible in 64.7% of cases and probable in 25.7% of cases by researchers. Only 12.7% of patients had laboratory data and/or medical record confirmation of suspected ADRs. The psychiatry clinic was less likely to confirm suspected ADRs compared to the epilepsy clinic (OR = 0.412, p = 0.022). Confirmation of patient-reported ADRs with either laboratory data or medical records was uncommon. Recording patient-reported ADRs in patients' medical history and monitoring laboratory tests related to patient-reported symptoms should be promoted to increase the safety of ASD treatment.

Cannabinoid-based medicines in clinical care of chronic non-cancer pain: an analysis of pain mechanism and cannabinoid profile

Aim: Among treatments for chronic non-cancer pain (CNCP), cannabinoid-based medicines (CBMs) have become extremely popular. Evidence remains modest and limited primarily to delta-9-tetrahydrocannabinol (THC) for neuropathic pain; nevertheless, the use of various CBMs, including cannabidiol (CBD) to treat neuropathic, nociceptive, and mixed pain has increased globally. This observational case-series assessed the impact of CBMs as a complementary treatment by pain mechanism and cannabinoid profile over three months. Methods: An analysis of patients with CNCP and treated with CBMs who consented to an ongoing registry was performed. Outcomes were patient-reported such as the Edmonton symptom assessment system-revised, brief pain inventory-short form, and 36-item short form health survey. Data from patients with complete outcomes for baseline and 3-month follow-up was extracted. Characteristics of adverse drug reactions (ADRs), including a description of the suspected product were also assessed. Results: A total of 495 patients were part of this analysis (mean age = 56 years old; 67% women). At 3-month, the proportional use of THC:CBD balanced and THC-dominant products increased. Patients with neuropathic pain had higher pain-severity scores vs. nociceptive pain. In addition to patients with neuropathic pain, patients with nociceptive and mixed pain also reported improvements in pain severity and secondary symptoms such as anxiety, depression, drowsiness, fatigue, sleep disturbances, and overall, health-related quality of life. THC-dominant treatment is more likely to be recommended when pain is severe, whereas CBD-dominant is favored for less severe cases. ADRs were more frequent among cannabis-naive patients and included dizziness, headache, and somnolence among others. Conclusions: Findings suggest that CBMs can be effective for neuropathic as well as nociceptive and mixed pain. THC is more frequently recommended for neuropathic and severe pain. Future research on CBMs in pain management must include details of CBM composition, and pain mechanism and must consider potential ADRs.

Adverse drug reactions in neonatal intensive care unit: Characteristics and risk factors

Adverse drug reactions (ADRs) in neonates can significantly affect expected clinical outcomes. The aim of this study was to analyze the prevalence and characteristics of ADRs and identify the risk factors involved in a neonatal intensive care unit (NICU). A prospective cohort study based on intensive pharmacovigilance was carried out in NICU of a public teaching hospital in the south of Mexico. Neonates admitted to the NICU who had between 1 and 90 days of age, with at least 24 hours of hospitalization, and a confirmed suspicion of ADRs were included. The prevalence and characteristics of ADRs were analyzed. Relative ratios (RR) were estimated with 95% confidence intervals (CI) to evaluate the risk factors of ADRs (p˂0.05). 998 newborns were included, 109 ADRs were detected in 75 newborns, the cumulative incidence was 7.51% and the ADRs were mainly probable imputability and moderate severity. The therapeutic group most frequently related to the development of ADRs was anti-infectives for systemic use and the blood and lymphatic system was most affected by the ADRs. Identified risk factors were: female sex (RR 1.58; 95% CI 1.01-2.47), prematurity (RR 5.6; 95% CI 3.45-9.11), low birth weight (RR 2.52; 95% CI 1.63-3.91), length of hospitalization &gt;15 days (RR 12.95; 95% CI 7.89-21.25) and drugs administered &gt;5 (RR 5.92; 95% CI 2.6-13.48). These results should be considered and studied in greater depth, which will allow the prevention of the development of ADRs in this group of patients.

Pattern of adverse drug reactions reported at the adverse drug reaction monitoring centre at tertiary care teaching hospital in North India

Background: The aim of the present study was to determine the pattern of adverse drug reactions (ADRs) reported at ADR monitoring centre (AMC) in Punjab. Methods: This observational retrospective study was done in department of Pharmacology, GGS Medical College and Hospital, Faridkot from September 2020 to August 2021. A total of 148 ADRs were reported during the study period. Each ADR was analyzed for demographic data and characteristics of ADR. Assessment of causality, severity and preventability was done according to WHO UMC scale, modified Hartwig and Siegel scale and Modified Schumock and Thornton Preventability Scale respectively. Results: A total of 148 ADRs were reported from both outpatients and in patients of various departments. Most of the ADRs were found in males (55%) and patients of age group 31-45 years (33%). Majority of ADRs were reported from dermatology department (40%). Overall, 38% of ADRs were due to antimicrobial drugs. Most of the ADRs were reported as possible (57%), followed by probable (41%) as per WHO causality assessment. Most of the ADRs were moderate severity (83%). 97% of the ADRs were found to be definitely preventable type. Conclusions: We concluded that most of the ADRs were reported from antimicrobial drugs, so it is advisable to have close monitoring of the antimicrobial drug therapy to prevent ADRs in the patients. Although the majority of ADRs were moderate in nature but mostly were recovered. The study of ADRs in a particular institute using demographic patterns will contribute to patient safety by sensitizing the clinicians in that particular institute.

Analysis of Burden and Outcomes of Anticoagulant Induced Adverse Drug Effects at a Tertiary Care Centre

Background: Anticoagulants are among the most commonly used drugs in hospitalized patients known to cause adverse drug reactions (ADRs). They have commonly been used as standard therapy in venous thromboembolism, stroke prevention, etc. Objectives: The authors aimed to assess the incidence of ADRs, clinical profile, severity and causality among the admitted patients taking anticoagulants in a tertiary care hospital. Materials and Methods: This was a hospital-based, prospective, observational, non-interventional cohort study undertaken in the General Medicine Wards of King Edward Memorial Hospital, Mumbai from June 2017 to December 2018. Every patient’s data was recorded using a structured ADR reporting form. The baseline parameters, medical history and underlying diseases, clinical data, characteristics of ADRs, and details of medication responsible for ADRs, as well as details of the drugs used for treatment of ADRs were recorded. The data was analyzed using descriptive statistics with the Statistical Packages for the Social Sciences (SPSS) version 26.0 software. Results: Out of the 164 patients admitted due to ADRs within the study period, 32 (19.5%) had developed ADRs due to anticoagulant treatment. Most anticoagulant-related ADRs involved the vascular system (n = 32). The severity of ADR was found to be mild in one patient (3.1%), moderate in 22 patients (68.8%), and severe in nine patients (28.1%). Twenty (62.5%) patients completely recovered, nine (28.1%) patients were still recovering (at the time of the analysis of the data), and three (9.4%) patients had a fatal outcome. Presence of systemic comorbidities and polypharmacy were found to be significant risk factors associated with anticoagulant-associated ADRs. Conclusion: Anticoagulants commonly cause ADRs in the study population. Patient education at the time of prescription can prevent many ADRs due to medication error or poor compliance. In addition, installing a better surveillance system in hospitals could alleviate the prevalence of ADRs.

Adverse drug reactions in geriatric psychiatry—retrospective cohort study of a 6-year period

ObjectiveTo investigate the frequency and characteristics of adverse drug reactions (ADRs) that occurred on the gerontopsychiatric ward of Hannover Medical School over a 6-year period.DesignRetrospective monocentric cohort study.ResultsSix hundred thirty-four patient cases (mean age 76.6 ± 7.1 years; 67.2% female) were analysed. In total, 92 ADRs in 56 patient cases were registered in the study population. The overall ADR prevalence, the ADR prevalence upon hospital admission, and the ADR prevalence during hospitalisation were 8.8%, 6.3%, and 4.9%, respectively. The most frequent ADRs were extrapyramidal symptoms, alterations in blood pressure or heart rate, and electrolyte disturbances. Of note, two cases of asystole and one case of obstructive airway symptoms related to general anaesthesia in the context of electroconvulsive therapy (ECT) were detected. The presence of coronary heart disease was associated with an increased risk of ADR occurrence (odds ratio (OR) 2.92, 95% confidence interval (CI) 1.37–6.22), while the presence of dementia was associated with a decreased risk of ADR development (OR 0.45, 95% CI 0.23–0.89).ConclusionsType and prevalence of ADRs in the present study were largely in accordance with previous reports. By contrast, we did not observe a relationship between advanced age or female sex and ADR occurrence. We detected a risk signal for cardiopulmonary ADRs related to general anaesthesia in the context of ECT that warrants further investigation. Elderly psychiatric patients should be carefully screened for cardiopulmonary comorbidities before initiation of ECT.

Patient involvement in pharmacovigilance: determinants and evolution of reporting from 2011 to 2020 in France

IntroductionBecause patients and patient organizations want to strengthen their role in the care pathway and drug evaluation and in order to improve pharmacovigilance activities, European competent authorities implemented regulations to allow direct reporting of adverse drug reactions related to medicinal products by patients in 2012.ObjectivesTo describe evolution and analyze determinants of patient reporting activity in France in order to assess patient involvement in pharmacovigilance.MethodUsing the French national pharmacovigilance database, univariate and multivariate analyses were performed to compare the characteristics of adverse drug reaction (ADR) reports from patients and healthcare professionals (HCP) between 2011 and 2020. The relationship between regional patient ADR report activity and regional care provision and socio-professional characteristics was analyzed using the principal component analysis.ResultsA significant and higher increase in ADR reports over time from patients (r = 0.89, p < 0.001) compared to HCP (r = 0.27, p = 0.002) has been observed. Patient ADR report activities compared to HCP concerned more women (80% vs. 55%, p < 0.001), younger age classes (p < 0.001), reporting through web portal (83% vs. 17%, p < 0.001), and less serious events (26% vs. 63%, p < 0.001). In the principal component analysis, regional patient reporting activity was related to socio-professional categories, age classes, and densities of hospital beds and physicians.ConclusionOur results confirm an increasing involvement of patients in ADR report activities. The determinants of patient reporting activities are not only related to drug and medical factors but also to social factors. Digital tools may also play a role in health democracy in pharmacovigilance.

Analysis of burden and outcomes of anti-tuberculosis therapy-induced adverse drug effects at a tertiary care center

Background: Tuberculosis (TB), one of the most ancient diseases known to mankind, is one of the ten major causes of mortality worldwide. Combinations of antibiotics, called anti-TB therapy (ATT), are given for a period of six months or more as treatment. Aims and Objectives: The aim of this study was to assess the incidence of adverse drug reactions (ADRs), clinical profile, severity and causality among the admitted patients taking ATT in a tertiary care hospital. Materials and Methods: This was a hospital-based, prospective, observational and non-interventional cohort study undertaken in the General Medicine wards of the hospital. This study was conducted from June 2017 to December 2018. The Patients’ data was recorded using a structured ADR reporting form. The baseline parameters, medical history and details of underlying diseases, clinical data, characteristics of ADRs and details of medication responsible for ADRs as well as medication for treatment of ADRs were recorded. The data was analyzed using descriptive statistics with the Statistical Packages for the Social Sciences (SPSS) version 26.0 software. Results: Out of the 164 patients admitted due to ADRs within the study period, 45 (27.4%) developed ADRs due to anti-TB treatment. Most ATT-related ADRs involved the liver (n=39). The severity of ADR was found to be mild in two patients (4.4%), moderate in 28 patients (62.5%) and severe in 15 patients (33.3%). 16 patients (35.6%) completely recovered, 23 patients (51.1%) were still recovering (at the time of the analysis of the data), one patient (2.2%) did not recover and five patients (11.1%) had a fatal outcome. The presence of systemic comorbidities and polypharmacy was found to be a significant risk factor associated with ATT associated ADRs. Conclusion: ATT is not without its side effects. About 27.4% of the patients on ATT in our study developed ADRs, a few resulting in fatality. Educating the patients about possible ADRs associated with ATT at the time of prescription can improve patient compliance and strengthen the doctor-patient relationship. Early diagnosis and treatment of ADRs associated with ATT is paramount. This requires a better surveillance system, which India is in a dire need for.