Incidence Rate Of Adverse Drug Reactions Research Articles

Prospective,multi-center,and large-scale hospital centralized monitoring of clinical safety of Reduning Injection in 100249 children cases

This study utilized a prospective, large-sample, multi-center, and registered key specialty approach of hospitals to monitor the application of Reduning Injection. A total of 100 249 adolescent patients aged 14 years and below who received Reduning Injection were monitored, resulting in 83 cases of adverse events, with 76 of them being classified as adverse drug reaction(ADR). The calculated incidence rate of ADR for Reduning Injection was 0.076%, indicating a very rare ADR. The main symptoms of ADR were pruritus, diarrhea, abdominal pain, vomiting, high fever, dyspnea, convulsion, and chills. All ADR cases were reported for the first time, including three new ADR cases and 73 known ADR cases. The categories of ADR was general ADR. All ADR was mild in severity. There were more males than females in ADR patients. One patient had a history of ADR, and the drug causing ADR was buprofen. The largest number of ADR cases occurred when the dosage of Reduning injection was 5-10 mL. The dropping speed was 30 drops or less per min, and the solvent type was 5% glucose injection. The most common manifestation of ADR patients was pruritus, followed by diarrhea, abdominal pain, vomiting, high fever, dyspnea, convulsions, and chills. 72 patients(94.74% of ADR patients) discontinued the drug, and three patients(3.95% of ADR patients) were given oxygen inhalation. 47 cases(61.84% of ADR patients) were treated with medication, of which dexamethasone was the most used(24 cases, 46.15% of ADR patients). 76 ADR patients were cured or improved. ADRs are more likely to occur when diagnosed with acute bronchitis by western medicine and cough by traditional Chinese medicine(TCM), TCM syndrome type is wind heat syndrome, and the combination medicine is ambroxol hydrochloride and bromhexine hydrochloride injection, ascorbic acid/vitamin C injection. This result provides an evidence-based safety basis for active pharmacovigilance of Reduning Injection in adolescents aged 14 years and below.

Incidence and Predictors of Major Adverse Drug Reactions Among Human Immunodeficiency Virus–infected Children on Antiretroviral Treatment in West Amhara Comprehensive Specialized Hospitals, Northwest Ethiopia: A Multicenter Retrospective Follow-up Study

PurposeMajor adverse drug reactions (ADRs) are the leading causes of poor adherence, switching of drugs, morbidity, and mortality. A limited studies was conducted to investigate major ADR in developing countries including Ethiopia, and the purpose of this study was to assess the incidence and predictors of major ADRs among HIV-infected children receiving antiretroviral therapy (ART) in West Amhara Comprehensive Specialized Hospitals, Northwest Ethiopia. MethodsAn institutional-based retrospective follow-up study was conducted among 460 children receiving ART from January 1, 2014 to December 31, 2021. A simple random sampling technique was employed, and data were collected using Kobo Toolbox software and then deployed to STATA 14 for analysis. The Kaplan-Meier survival curve and the log-rank test were used to estimate and compare survival times. Both bivariable and multivariable Weibull regression models were fitted to identify predictors. Finally, an adjusted hazards ratio (AHR) with a 95% CI was computed, and variables with P < 0.05 were considered statistically significant predictors of major ADR. FindingsThe overall incidence rate of major ADRs was 5.8 (95% CI, 4.6–7.3) per 1000 child months. Being female (AHR, 2.71; 95% CI, 1.52–4.84), tuberculosis (TB)–HIV co-infection (AHR, 2.49; 95% CI, 1.32–4.68), World Health Organization stage (III and IV) (AHR, 2.52; 95% CI, 1.39–4.56), zidovudine-based (AHR, 2.84; 95% CI, 1.11–7.31), and stavudine-based (AHR, 5.96; 95% CI, 1.63–21.84) regimens were found to be significant predictors of major ADRs. ImplicationsThe major ADR incidence rate was high. Health professionals should employ early screening and close follow-up for children with advanced World Health Organization clinical staging, females, those with TB-HIV co-infection, and those receiving stavudine- and zidovudine-based initial regimens to reduce the incidence of major ADRs.

Real-world reported adverse events related to systemic immunomodulating therapy in patients with atopic dermatitis: Results from the TREAT NL (TREatment of ATopic eczema, the Netherlands) registry.

Evidence on the (long-term) safety of systemic immunomodulating therapies in atopic dermatitis (AD) generated by real-world data is sparse. To describe real-world reported adverse drug reactions (AEs) related to systemic immunomodulating therapy in patients with AD and to compare the incidence rates of AEs with the Summaries of Product Characteristics (SmPCs). We conducted an observational prospective multi-centre cohort study, using the TREAT NL registry. All severe AEs, AEs of special interest and serious AEs in adult and paediatric patients on systemic immunomodulating treatment (ciclosporin, methotrexate, azathioprine, mycophenolic acid, dupilumab, tralokinumab, baricitinib and upadacitinib) were assessed. Incidences rates of all (potentially) drug-related AEs were standardized in patient years and compared to the cumulative incidences in the associated SmPCs. We collected 422 patient years of safety data from 266 patients, of whom 129 (48.5%) reported a total of 224 (potentially) drug-related AEs. Compared to dupilumab's SmPC, higher incidence rates were found for four AEs (reported ≥5 times): eosinophilia, blepharitis, dry eyes and head and neck erythema (i.e. dupilumab facial redness). A higher incidence rate of fatigue was found in patients on oral methotrexate in our cohort compared to the SmPC. Two new drug-related AEs (reported ≥5 times) were found in patients on dupilumab, including non-infectious conjunctivitis and meibomian gland dysfunction. Real-world reported AEs captured in AD patient registries can add information on the estimated incidence of AEs and benefit clinical decision aids. Future studies using data derived from the TREAT NL registry combined with data from other registries within the TREAT Registry Taskforce will provide more information on (rare) AEs associated with immunomodulating therapy in AD patients.

Detection of Adverse Drug Reactions in COVID-19 Hospitalized Patients in Saudi Arabia: A Retrospective Study by ADR Prompt Indicators.

Seeking an alternative approach for detecting adverse drug reactions (ADRs) in coronavirus patients (COVID-19) and enhancing drug safety, a retrospective study of six months was conducted utilizing an electronic medical record (EMR) database to detect ADRs in hospitalized patients for COVID-19, using "ADR prompt indicators" (APIs). Consequently, confirmed ADRs were subjected to multifaceted analyses, such as demographic attribution, relationship with specific drugs and implication for organs and systems of the body, incidence rate, type, severity, and preventability of ADR. The incidence rate of ADRs is 37%, the predisposition of organs and systems to ADR is observed remarkably in the hepatobiliary and gastrointestinal systems at 41.8% vs. 36.2%, p < 0.0001, and the classes of drugs implicated in the ADRs are lopinavir-ritonavir 16.3%, antibiotics 24.1%, and hydroxychloroquine12.8%. Furthermore, the duration of hospitalization and polypharmacy are significantly higher in patients with ADRs at 14.13 ± 7.87 versus 9.55 ± 7.90, p < 0.001, and 9.74 ± 5.51 versus 6.98 ± 4.36, p < 0.0001, respectively. Comorbidities are detected in 42.5% of patients and 75.2%, of patients with DM, and HTN, displaying significant ADRs, p-value < 0.05. This is a symbolic study providing a comprehensive acquaintance of the importance of APIs in detecting hospitalized ADRs, revealing increased detection rates and robust assertive values with insignificant costs, incorporating the hospital EMR database, and enhancing transparency and time effectiveness.

A RETROSPECTIVE STUDY: ANALYSIS OF ADVERSE DRUG REACTION IN PEDIATRIC PATIENTS IN A TERTIARY CARE HOSPITAL

Objective: The objective of this study was to analyze various parameters such as admission type, demographics, type of reaction, organ system classification, drugs involved, action is taken, reaction outcome, causality assessment, severity assessment, and the preventability of Adverse drug reactions (ADRs) in pediatric patients. Methods: This retrospective observational study was conducted during the period of September 2017 to June 2020 (34 months) at the ADR monitoring center, Department of Pharmacology, Jawaharlal Nehru Medical College, Ajmer, Rajasthan. All spontaneously reported ADRs were evaluated using various parameters such as type of reaction, causality assessment, preventability, and severity. Results: In the present study, 72 (7.27%) ADRs were reported in relation to 65 pediatric patients. In this study, more ADRs were reported in male (53.85%) as compared to female (46.15%) pediatric patients. The majority of ADRs were considered type B (63.89%), probable (87.5%), moderate (51.39%), and definitely preventable (88.89%) in nature. The majority of ADRs were reported due to antimicrobial classes of drugs, including anthelmintic drug (Albendazole), followed by glycopeptide antibiotic (Vancomycin) and third-generation cephalosporin antibiotics (Ceftriaxone, Cefotaxime, and Cefixime). The organ systems most commonly affected were skin and subcutaneous tissue disorders (47.22%), followed by general disorders and administration site conditions (20.83%) and gastrointestinal disorders (16.67%). Conclusion: The present study 30 different types of suspected ADRs that were reported with multiple frequencies, with included 34 different categories of drugs and combinations of drugs. The majority of patients recovered, with associated ADR, after necessary medical intervention and management. Our purpose is to minimize the incidence rate of ADRs in the pediatric population.

Safety and Effectiveness of Empagliflozin in Korean Patients with Type 2 Diabetes Mellitus: Results from a Nationwide Post-Marketing Surveillance.

To evaluate the safety and effectiveness of empagliflozin in routine clinical settings, we collected and assessed the clinical profiles of Korean patients with type 2 diabetes mellitus. This was a post-marketing surveillance study of empagliflozin 10 and 25 mg. Information on adverse events and adverse drug reactions (ADRs) was collected as safety data sets. Available effectiveness outcomes, including glycosylated hemoglobin (HbA1c) level, fasting plasma glucose, body weight, and blood pressure, were assessed. The incidence rate of ADRs was 5.14% in the safety dataset (n=3,231). Pollakiuria, pruritis genital, and weight loss were the most common ADRs. ADRs of special interest accounted for only 1.18%, and there were no serious events that led to mortality or hospitalization. In the effectiveness data set (n=2,567), empagliflozin significantly reduced the mean HbA1c level and body weight during the study period by -0.68%±1.39% and -1.91±3.37 kg (both P<0.0001), respectively. In addition, shorter disease duration, absence of dyslipidemia, and higher baseline HbA1c levels were identified as the clinical features characteristic of a "responder" to empagliflozin therapy. Empagliflozin is a safe and potent glucose-lowering drug in routine use among Korean patients with type 2 diabetes mellitus. It is expected to have better glycemic efficacy in Korean patients with poorly controlled type 2 diabetes mellitus.

GENDER CHARACTERISTICS OF ADVERSE DRUG REACTIONS DEVELOPMENT: EXPERIENCE OF REGIONAL DATABASE ANALYSIS

The aim of the article is the gender characteristics study of the adverse drug reactions (ADRs) development based on the data of the notification forms registered in the regional database ARCADe (Adverse Reactions in Crimea, Autonomic Database), for the period from 2009 to 2018.Materials and methods. The objects of the study were 6903 notification forms about adverse drug reactions recorded in the regional database called ARCADe (Adverse Reactions in Crimea, Autonomic Database) for the period from 2009 to 2018. The classification of drugs for separate pharmacological groups was carried out using the codes of the Anatomical Therapeutic Chemical (ATC) classification system of the World Health Organization (WHO) medicinal products, the instructions data of the State Registers of medicinal preparations used in the Russian Federation and Ukraine (for the cases registered before the entry of the Republic of Crimea into the Russian Federation).Results. A general analysis of the number of cases of the adverse drug reactions (ADRs) development in patients of different genders made it possible to determine that 59.9% (4132 notification forms) of ADRs cases were observed in female patients; 37.7% (2602 cases) – in male patients. In 169 cards (2.4%), information about a patient’s gender was missing. The groups with the largest number of the registered cases of ADRs were antimicrobial agents for a systemic use (2864 cases, 41.5% of the total number of the ADRs registered cases), the drugs affecting the cardiovascular (811 cases, 11.7%) and nervous (734 cases, 10.6%) systems. In each of the presented groups, the incidence rate of ADRs in female patients exceeded that in men.Conclusion. The study of the gender characteristics of the pharmacotherapy safety, carried out on the basis of the notification forms of the ADRs data registered in the Republic of Crimea, confirmed a higher likelihood of developing ADRs in female patients. This may be due to the peculiarities of the pharmacokinetics and pharmacodynamics of drugs in the female body, psychological factors, a more frequent use of drugs by this category of people. The implementation of the drug, taking into account specific features of each gender, can lead not only to better treatment outcomes, but also to increased patients’ compliance.

Annual Costs Incurred in Managing Adverse Drug Reactions Attributable to Fixed-Dose Combination Highly Active Antiretroviral Therapy in an Outpatient Antiretroviral Clinic in Gauteng: A Budget Impact Analysis

ObjectivesThis study aimed to identify adverse drug reactions (ADRs) attributable to tenofovir (TDF)- and zidovudine (AZT)-based fixed-dose combinations of highly active antiretroviral (ARV) therapy and subsequently determine the annual costs incurred in managing these ADRs and the budget implications in an outpatient ARV clinic in Mamelodi, Pretoria. MethodsThis retrospective cohort study reviewed deidentified clinical data for ADRs. Medical charts of human immunodeficiency virus–positive patients, who were receiving either TDF- or AZT-based fixed-dose combinations of ARV therapy, were analyzed. Costs were converted to US dollars using the rate of US$1 equivalent to ZAR14.3853. Based on the costs and the incidence rates of ADRs observed in the analysis, a decision tree model was established to estimate the cost impact of ADR management on the clinic’s budget. ResultsA total of 469 patient files were analyzed (62% female vs 38% male). The mean age at the start of ARV therapy for the cohort was 36.6 years (95% confidence interval 35.74-37.45), and the mean baseline CD4 count was 380 (95% confidence interval 343-418). The incidence of ADRs to TDF- or AZT-based fixed-dose combinations of ARV therapy was found to be 24.95%. The study revealed that US$29.70 was the cost attributed to ADRs owing to TDF-based regimens, whereas US$32.53 was the cost attributed to ADRs owing to AZT-based regimens, per patient, annually. Costs attributed to gastrointestinal-related ADRs were the highest in comparison with other ADRs. The estimated total cost of ADRs attributed to AZT-based therapy was US$556.40, and the estimated total cost of ADRs attributed to TDF-based ARV therapy per annum was US$2348.80 for the 1221 patients who started receiving ARV therapy between July 2017 and June 2018 at the clinic. ConclusionsDespite the estimated costs related to ADRs in the study being lower than those in similar studies, there remains a notable budget impact, particularly in a resource-limited setting. The study findings allow for improved budget forecasts in an ARV clinic setting.

Incidence and Predictors of Severe Adverse Drug Reaction Among Patients on Antiretroviral Therapy in Tigray, Ethiopia: A Retrospective Cohort Study.

BackgroundThe aim of the present study was to assess the incidence and predictors of severe adverse drug reactions among patients on antiretroviral therapy (ART) in Tigray, North Ethiopia.MethodsWe employed four years retrospective cohort study using a structured data extraction sheet. The study populations were HIV patients on ART follow-up from January 2017 to February 2020 in the study area. Severe adverse drug reaction (ADR) was an outcome variable and defined as having any one of the complaints related to ARV drug reaction due to regimen change, discontinuation, and/or in-patient care. Data were collected using a structured data extraction sheet. A Cox proportional hazard regression model was used to determine the relationship between the predictors and the outcome variable. The mean survival time of the cohort was estimated using the Kaplan–Meier method.ResultsThe incidence rate of ADRs was 3.6 (95%CI: 2.9–4.35) per 100-person years. HIV patients with no formal education (adjusted hazard ratio=1.58, 95%CI: 1.03–2.41), with experience of regimen change (adjusted hazard ratio=1.59, 95%CI: 1.12–2.91), who ever took other medication (adjusted hazard ratio=1.49, 95%CI: 1.05–2.15) and with lower body mass index (adjusted hazard ratio=3.24, 95%CI: 1.18–4.91) were more likely to develop severe adverse drug reaction.ConclusionADRs were diagnosed an inconsiderable number of HIV patients on ART and factors were patient and drug-related. To minimize it, special attention is sought for patients with no formal education, previous regime change, whoever took other medication, and who have lower body mass index levels.

TPMT and HLA-DQA1-HLA-DRB genetic profiling to guide the use of azathioprine in the treatment of interstitial lung disease: First experience

BackgroundThe choice of immunosuppressive therapy in interstitial lung disease (ILD) other than idiopathic pulmonary fibrosis (IPF) is based on safety profile and expected efficacy. Azathioprine is one of the most commonly used agents to treat ILD. The immunosuppressive effect and pancreatitis risk of azathioprine are influenced by the activity of the enzyme thiopurine methyltransferase (TPMT) and by the genetic mutations in HLA-DQA1-HLA-DRB locus, respectively. We hypothesized that systematic genotyping prior to starting azathioprine improves the rate of discontinuation of immunosuppressive therapy and the total incidence of adverse drug reactions (ADRs). MethodsEighty-two patients with ILD other than IPF were included in the study. The rate of immunosuppressive therapy discontinuation due to major ADRs and the total incidence of ADRs were compared between a cohort of genotyped patients (n = 49) and an untested cohort of patients (n = 33). ResultsThirty-seven out of 49 patients in the genotyped cohort and 27 out of 33 patients in the untested cohort were started on azathioprine. The rate of immunosuppressive therapy discontinuation due to major ADRs was significantly lower (6/49) in the genotyped cohort compared to the untested cohort (11/33; p = 0.0276). All but one discontinuation due to severe ADRs occurred within a month of therapy. However, the total incidence rate of ADRs was very similar in the 2 cohorts (0.025 in the genotyped cohort vs. 0.023 in the untested cohort). ConclusionIn patients with ILD other than IPF, genotyping for azathioprine metabolism prior to starting therapy is associated with a significantly reduced rate of immunosuppressive therapy discontinuation due to major ADRs, with prevention of bone marrow suppression and pancreatitis, but without a reduction of the total incidence of ADRs. While these data support the use of genetic profiling prior to starting azathioprine to treat ILD, its cost effectiveness remains to be established.

Predictors of adverse drug reaction among adult HIV-infected patients on antiretroviral therapy in government hospitals of Kaffa Zone, Ethiopia; November 2018: a retrospective cohort.

Introductionincidence of adverse drug reactions (ADR) associated with antiretroviral therapy (ART) was higher in developing countries. In two teaching hospital in Ethiopia: Debremarkose 23% and Yirgalem 73.2% of study participants reported at least one ADR. Since there was limited information about ADR in the study area; we aimed to determine its incidence-rate and predictors.Methodswe conducted retrospective cohort study using medical records of HIV-infected patients enrolled on ART between 2006 and 2017 in government hospitals of Ethiopia. ADR was defined as report of at least one unwanted response to ART. We run descriptive and cox regression analysis (CRA).Resultsincidence-rate of ADR was 4.1 per 100 person-years (py). Hazards of ADR among patients living at rural was almost two times than at urban; [Adjusted hazard ratio (AHR): 1.94(95% (CI): 1.18, 3.20)]. Stavudine (D4T)-Lamivudine (3TC)-Nevirapine (NVP) had about two times [AHR: 1.78(95%CI: 1.03, 3.08)], Zidovudine(AZT)-3TC-NVP had about two times [AHR: 2.34 (95%CI: 1.20, 4.57)], D4T-3TC-Efaviranze(EFV) had about three times [AHR: 2.86(95%CI: 1.38, 5.95)] and AZT-3TC-EFV had about two times [AHR: 2.16(95%CI: 1.21,3.90)] hazards of ADR than Tenofovir(TDF) based regimens. Being WHO clinical stage III had about two times hazard of ADR [AHR: 2.46 (95%CI: 1.22, 4.95)] and IV had about four times hazard of ADR [AHR: 4.32 (95%CI: 1.88, 9.93)] than stage I.Conclusionrisk of ADR was higher among adult HIV-infected patients on ART living in rural, WHO clinical stage III and IV, and patients on AZT and D4T based regimen. AZT should not be given as an alternative treatment, increase access of TDF regimens.

A 3-year postmarketing study on the safety and effectiveness of once-monthly risedronate in Japanese patients with osteoporosis

ObjectivesThis postmarketing study aims to evaluate the safety and effectiveness of oral administration of risedronate at 75 mg once monthly for 36 months in patients with osteoporosis in Japan. MethodsParticipants were ambulatory outpatients with osteoporosis who were ≥ 50 years old and had prevalent vertebral fractures. Outcomes were the incidence rate of adverse drug reaction (ADR), cumulative incidence of vertebral, nonvertebral, and hip fractures, the percent changes of lumbar spinal L2–4 bone mineral density (BMD), and low back pain. In addition, medication compliance was examined. ResultsSafety, vertebral fractures, and other outcomes were analyzed in 542, 328, and 535 patients, respectively. In the safety analysis set, 88.38% of the patients were women and the mean age was 75.9 years. The monthly medication compliance rate ranged from 83.24% to 95.38%. The incidence rate of ADRs, including 4 severe ADRs, was 10.52% (n = 57). The common ADRs were gastrointestinal disorders, musculoskeletal, and connective tissue disorders. No osteonecrosis of the jaw was reported. The cumulative incidences (95% CI) of vertebral, nonvertebral, and hip fractures at 36 months were 12.58% (8.61–18.18), 6.59% (4.31–10.01), and 1.58% (0.64–3.88), respectively. The L2–4 BMD increased by 10.59% compared with baseline value (P < 0.01), and the proportion of patients with low back pain decreased to 30.77%, at 36 months. ConclusionsAdministering 75 mg of risedronate once a month remains a favorable compliance rate and may be useful for the treatment of patients, even the elderly, with osteoporosis in daily practice.

Adverse Drug Reaction due to Antidepressants among Patients with Depression in a Private Psychiatric Hospital of Nepal.

Background Adverse drug reactions (ADRs) are the known cause of morbidity and mortality, resulting in increased hospitalization, healthcare costs, complications, and decreased adherence in patients with depression. This study is aimed at evaluating adverse drug reactions due to antidepressants among patients with depression in the psychiatric hospital of Nepal. Methods A hospital-based prospective observational study was conducted among 47 patients using purposive sampling techniques among patients with depression visiting a private psychiatric hospital. The causality, severity, and preventability assessment of reported ADRs was performed using the Naranjo scale, modified Hartwig Siegel's Severity Assessment Scale, and Schumock and Thornton scale, respectively. The data collected were entered into and analyzed using IBM-SPSS 20.0. Results The incidence rate of ADR was found to be 4.54%, with females having a higher incidence rate of 5.56%. A total of 54 ADRs were reported. The majority of them were probable (30, 55.55%), moderate (36, 66.66%) and probably preventable (24, 44.44%). Most of the ADRs were managed either by stopping (19, 35.18%) or substituting (19, 35.18%) the suspected drug and 66.66% of the ADRs were recovered. Selective serotonin reuptake inhibitors (SSRIs) were associated with a higher number of ADRs i.e. 34. Conclusion The findings highlight the need for regular intensive monitoring of ADRs in psychiatric outpatients by clinical pharmacists for early detection and reduction of risk caused by ADRs associated with antidepressants.

Adverse drug reactions and nursing interventions in the treatment of non-Hodgkin's lymphoma by Aidi injection.

To explore adverse drug reactions (ADRs) and the effects of nursing interventions after Aidi injection for the treatment of non-Hodgkin's lymphoma (NHL). A total of 104 NHL patients treated in our hospital from March 2019 to March 2020 were selected. All patients underwent conventional chemotherapy, with a concomitant Aidi injection administered at different doses (40, 60, 80, and 100 mL). ADRs were analyzed for all patients, and the clinical outcomes of ADRs were recorded after specific nursing interventions were performed. A total of 17 NHL patients had ADRs, with a total incidence rate of 15.89% (total of 30 ADRs). In terms of different types of ADRs, inappetence accounted for the largest proportion, followed by skin pruritus and fever, phlebitis, nausea and vomiting, and chest distress and/or palpitation, the last of which shared the same proportion as chills and/or low fever and urticaria. The incidence rate of ADRs (total of 18 ADRs, 60.00%) was higher in NHL patients who were given 100 mL of Aidi injection. In terms of age and gender distribution of ADRs, there were 10 males (55.56%) and 7 females (44.44%), and ADRs were more common in patients aged 46-60 years old (total of 6 ADRs, 35.29%). Aidi injection mainly induced mild ADRs (total of 22 ADRs, 73.33%), and the resulting ADRs mostly occurred for <2 hours (total of 19 ADRs, 60.00%). After the specific nursing interventions were performed, no deaths due to ADRs occurred, and 12 (64.71%) cases were cured, 5 (29.41%) cases improved, and 1 (5.88%) case had no progression. Particular attention should be paid to ADRs in the treatment of NHL patients with Aidi injection. After ADRs occur, specific nursing interventions can aid in recovery and lead to improvements in prognosis.

Monitoring of adverse drug reactions in psychiatry outpatient department of a tertiary care hospital in Central India

Background: Adverse drug reactions (ADRs) are prevalent in patients taking psychotropic medications and can occur even at the normal doses used in the management of acute and maintenance phases of psychiatric disorders. Pharmacovigilance have cardinal role in alerting the healthcare providers from the possible ADRs and thus protecting the patients who are using psychotropic medications. To Monitor and estimate the incidence and nature of ADRs in psychiatry OPD of tertiary care hospital in central India and assess the causality, preventability and severity of documented ADRs.Methods: A prospective observational study was conducted in psychiatry out-patient department (OPD). Patients diagnosed with any psychiatric disorder and receiving psychotropic medications was included in the study. The recorded data were filled in the ADR form obtained from pharmacovigilance program of India (PvPI). Causality assessment was done using Naranjo scale and severity was assessed using Hartwig scale and preventability assessment using modified Schumock and Thornton’s scale.Results: The incidence rate of ADR was found to be 15.8%. A total of 61 ADRs were documented. Weight gain 14 (18.1%) followed by nausea 11 (14.2%) was the most commonly reported ADR. Atypical antipsychotics were the most common class of psychotropic drugs implicated in ADRs. Clonazepam 21 (27.2%) followed by amitriptyline 20 (25.9%) were associated with a maximum number of ADRs. Majority of the suspected ADRs were probable in nature (40.9%) followed by possible type (31%).Conclusions: Study revealed a moderate incidence of ADRs in patients attending the psychiatry OPD. Majority of the ADRs reported during the study were mild in nature and definitely preventable type.

Pneumocystis pneumonia in patients with rheumatic diseases receiving prolonged, non-high-dose steroids\u2014clinical implication of primary prophylaxis using trimethoprim\u2013sulfamethoxazole

ObjectivesTo investigate the incidence of pneumocystis pneumonia (PCP) and its risk factors in patients with rheumatic disease receiving non-high-dose steroid treatment, along with the risks and benefits of PCP prophylaxis.MethodsThis study included 28,292 treatment episodes with prolonged (≥ 4 weeks), non-high-dose steroids (low dose [< 15 mg/day, n = 27,227] and medium dose [≥ 15 to < 30 mg/day, n = 1065], based on prednisone) over a 14-year period. Risk factors for PCP and prophylactic effect of trimethoprim–sulfamethoxazole (TMP-SMX) were investigated if the 1-year incidence rate (IR) of PCP in each dose group was > 0.1/100 person-years. Cox regression with LASSO was used for analysis.ResultsOne-year PCP IR in the low-dose group was 0.01 (95% CI 0.001–0.03)/100 person-years, and only the medium-dose group showed eligible PCP IR for further analysis. In the medium-dose group, prophylactic TMP-SMX was administered in 45 treatment episodes while other episodes involved no prophylaxis (prophylaxis group vs. control group). In 1018.0 person-years, 5 PCP cases occurred exclusively in the control group, yielding an IR of 0.5 (0.2–1.2)/100 person-years. Concomitant steroid-pulse treatment and baseline lymphopenia were the most significant risk factors for PCP. Treatment episodes with at least one of these factors (n = 173, high-risk subgroup) showed higher 1-year PCP IR (3.4 (1.1–8.0)/100 person-years), while no PCP occurred in other treatment episodes. TMP-SMX numerically reduced the risk (adjusted HR = 0.2 (0.001–2.3)) in the high-risk subgroup. The IR of adverse drug reactions (ADRs) related to TMP-SMX was 41.5 (22.3–71.6)/100 person-years, including one serious ADR. The number needed to treat with TMP-SMX to prevent one PCP in the high-risk subgroup (31 (17–226)) was lower than the number needed to harm by serious ADR (45 (15–∞)).ConclusionIncidence of PCP in patients with rheumatic diseases receiving prolonged, medium-dose steroids depends on the presence of risk factors. Prophylactic TMP-SMX may have greater benefit than potential risk in the high-risk subgroup.

Efficacy and safety of combination of magnesium sulfate, phentolamine and nifedipine in treatment of patients with hypertensive disorder complicating pregnancy.

Efficacy and safety of the combination of magnesium sulfate, phentolamine and nifedipine in the treatment of patients with hypertensive disorder complicating pregnancy (HDCP) and its effect on hemodynamics and urinary protein level were investigated. One hundred and six patients with HDCP diagnosed at the Affiliated Hospital of Beihua University from February 5, 2016 to May 9, 2017 were retrospectively analyzed. Patients were divided into the magnesium sulfate group and the combination group, according to the therapeutic schemes. The efficacy 1 week later was observed. The general clinical data of the patients were recorded, and data were acquired with respect to hemodynamic indexes before and after treatment [changes of S/D ratio of umbilical artery flow, and cardiac index and total peripheral resistance (TPR)], the 24-h urinary protein level, clinical efficacy and safety [adverse drug reactions (ADR) and maternal and neonatal outcomes]. Before treatment, there was no statistically significant difference between the two groups in terms of S/D ratio of umbilical artery flow (P>0.05), while after treatment the S/D ratio was significantly lower than that before treatment in both groups (P<0.05). Before treatment, there was no statistically significant difference between the two groups in terms of cardiac index (P>0.05). TPR after treatment was significantly lower than that before treatment in both groups (P<0.001). Compared with the magnesium sulfate group, patients in the combination group had significantly lower 24-h urinary protein level after treatment (P<0.001), significantly higher total effective rate (P<0.05), significantly lower incidence rate of ADR (P<0.001), and significantly lower incidence rate of adverse maternal and neonatal outcomes (P<0.001). In conclusion, the combination of magnesium sulfate, phentolamine and nifedipine can significantly improve the hemodynamic indexes, the 24-h urinary protein level, the clinical efficacy, ADR and maternal and neonatal outcomes of patients with HDCP, therefore it is worthy of use in the clinic.

Prevalence and profile of adverse drug reactions in high-risk pregnancy: a cohort study

BackgroundCommonly used drugs in pregnant women include antihypertensives, hypoglycemic agents, analgesics, antimicrobials, antiemetics and antispasmodics but the use of medicines during pregnancy, especially in high-risk pregnancy, may be associated with high risk of adverse drug reactions (ADR). The objective of this study was to determine the risk of an adverse drug reaction in hospitalized high-risk pregnant women and the factors associated with their occurrence.MethodsThe study received IRB approval and all patients gave written informed consent. Observational cohort study conducted from September 2015 to November 2016 in 1070 pregnant women consecutively admitted to the high risk sector of the University Maternity Januário Cicco in Brazil. ADR were detected through daily active search. Risk factors for the occurrence of ADR were determined using multivariate logistic regression.ResultsThe mean age of the study population was 26.2 ± 7.2 years and gestational age was 31.2 ± 7.2 weeks. The average number of previous pregnancies was 2.4 ± 1.8 and 46.4% reported cases of previous abortion/miscarriage. ADR were observed in 10.7% of women. The main medicines involved, with the incidence rate of ADR per 100 prescriptions of the drug (IR), were parenteral scopolamine (IR 14.9%), methyldopa (IR 15.9%), insulin (IR 8.46%), oral scopolamine (IR 3.58%), captopril (IR 2.38%) and ceftriaxone (IR 18.4%). Multivariate analysis showed that only gestational age in weeks (odds-ratio 0.97, 95% confidence interval 0.95–0.98) was related to the occurrence of adverse reactions.ConclusionLower gestational age is a risk factor for high-risk pregnant women, increasing the likelihood of adverse reactions, with parenteral medications being those that have the highest potential risk of harm.

Safety and Effectiveness of Ipragliflozin for Type 2 Diabetes in Japan: 12-Month Interim Results of the STELLA-LONG TERM Post-Marketing Surveillance Study.

IntroductionThe present interim report of the STELLA-LONG TERM study aimed to examine the safety and effectiveness of ipragliflozin in real-word clinical practice in Japan using data up to 12 months. We also evaluated the effect of ipragliflozin on aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels in patients with normal vs. abnormal liver function.MethodsThis is an ongoing 3-year post-marketing surveillance study. We analyzed data from Japanese type 2 diabetes mellitus (T2DM) patients who were first prescribed ipragliflozin between 17 July 2014 and 16 October 2015 at participating centers in Japan, and whose data were locked by 16 January 2018. The incidence of adverse drug reactions (ADRs) was evaluated for safety. Changes in glycemic control and body weight were evaluated for effectiveness. The effect on liver function was evaluated by changes in the fatty liver index, and changes in AST and ALT were evaluated in patients with normal and abnormal liver function.ResultsThe safety analysis set comprised 11,051 patients and the efficacy analysis set comprised 8788 patients. The incidence rates of ADRs and serious ADRs were 14.6% (1616/11,051) and 0.97% (107/11,051), respectively. Significant reductions (all P < 0.001 vs. baseline, paired t test) in glycated hemoglobin (− 0.8%), fasting plasma glucose (− 31.9 mg/dL), body weight (− 2.9 kg), and fatty liver index (− 8.7) were observed. In patients with normal liver function at baseline, no clinically significant changes in AST and ALT were observed. In patients with abnormal liver function at baseline, clinically and statistically significant decreases (P < 0.05 vs. baseline, two-sample t test) in AST (− 9.0 U/L) and ALT (− 14.7 U/L) levels were observed.ConclusionIpragliflozin was effective and well tolerated in Japanese patients with T2DM over 12 months in the real-world clinical setting. Improvements in liver function parameters (AST and ALT) were observed in T2DM patients with abnormal liver function.Trial RegistrationClinicalTrials.gov identifier, NCT02479399.FundingAstellas Pharma Inc., Japan.

Incidence of adverse drug reactions in a paediatric ward of a Malaysian hospital: A prospective observational study

Purpose : To investigate the incidence, characteristics and risk factors of adverse drug reactions (ADRs) in hospitalized children in a Malaysian hospital. Methods : Patients admitted to the Paediatric Department of Hospital Ampang in Kuala Lumpur, Malaysia were monitored for occurrence of ADRs by spontaneous reporting or daily review of their case notes. Characteristics of ADRs were categorised and ADRs were analysed for causality, severity and preventability. Multivariate analyses were performed to determine associations between certain selected risk factors and ADR occurrence. Results : In 423 paediatric patients admitted in Hospital Ampang (436 admissions), the ADR incidence rate was 8.0 % (95 % CI, 5 - 11 %). The most commonly involved medications were systemic antibacterial drugs (77.4 %). About 61.3 % of the ADRs were of probable causality and 12.9 % were definitely preventable. No severe ADRs were detected, with 41.9 % being moderate and 58.1 % being mild, based on a severity scale. Younger children (OR = 3.387, 95 % CI, 1.377, 8.334) and the number of systemic antibacterial drugs given (OR = 1.469, 95 % CI 1.201, 1.798) were potential risk factors associated with ADRs. Conclusion : ADRs occur at a significant rate in the Malaysian children admitted to the hospital studied. Further studies are needed to provide drug safety data for the paediatric population in Malaysia. Keywords : Adverse drug reaction, Children, Paediatric, Drug safety