Overall Incidence Of Adverse Drug Reactions Research Articles

Time to develop adverse drug reactions and associated factors among children HIV positive patients on antiretroviral treatment in North West Amhara Specialized Hospitals: Retrospective cohort study, 2022.

Adverse drug reactions (ADRs) are harmful and unintended reactions to medicines given at standard doses through a proper route of administration for the purpose of prophylaxis, diagnosis, or treatment. The objective of this research paper was to assess median time to development of ADRs and associated factors among children HIV positive patients on antiretroviral treatment (ART) in North West Amhara Specialized Hospitals. The adverse drug effect survival time was estimated using the Kaplan-Meier survival method and log-rank test curves was applied for analyze "time-to-event" data. Cox regression model was used to identify the associated factors. Adjusted hazard ratios with their respective 95% confidence intervals (CIs) were estimated and a value of p less than 0.05 was used to declare the presence of a significant association. The overall incidence of ADRs was 0.67 (95% CI: 3.74-4.44) per 10,000 person-year observation, with a median of 57 months. Adults are presenting with opportunistic Infections (OIs) experiences, baseline CD4 < 200 cells/µL counts, 1e, tenofovir disoproxil fumarate-lamivudine-efavirenz ART regimen, bedridden baseline functional status, World Health Organization (WHO) clinical stage II and III were notably associated with the incidence of ADRs development. ADRs were uncommon in this study. predictors, such as OIs experiences, a low CD4 count, ART regimen, an advanced WHO stage, and bedridden functional status were significantly associated with ADRs.

Incidence and severity of nonionic low-osmolar iodinated contrast medium-related adverse drug reactions in the Republic of Korea: Comparison by generic.

We aimed to report the incidence and severity of nonionic low-osmolar iodine contrast medium (ICM)-related adverse drug reactions (ADRs) in the Republic of Korea, by analyzing data from our single tertiary institution and published Korean reports, and to determine whether there is a difference in the incidence of ICM-related ADR by ICM generics. A total of 1,161,419 consecutive contrast-enhanced computed tomography (CT) examinations between January 2016 and December 2021 at Asan Medical Center were included. A systematic search of the literature investigating the incidence of ICM-related ADR in the Republic of Korea published up to December 31, 2021 was performed. We pooled these outcomes with those of our study using a binomial-normal model, and the pooled incidences of ADRs were compared among ICM generics using chi-square tests. Seven studies with a total of 2,570,986 contrast-enhanced CT examinations from 12 institutions were included. The pooled incidences of overall, mild, moderate, and severe ICM-related ADRs in the Republic of Korea were 0.82% (95% CI: 0.61%-1.10%), 0.72% (95% CI: 0.50%-1.04%), 0.11% (95% CI: 0.08%-0.15%), and 0.013% (95% CI: 0.010%-0.018%), respectively. In multiple pairwise comparisons, there were no significant differences in the overall incidence of ADRs between ICM generics, except iomeprol versus iobitridol and iomeprol versus iohexol. For moderate and severe ADRs, there were no significant differences in ADR incidence between ICM generics. The incidence of moderate and severe ICM-related ADRs did not differ among ICM generics. Our results suggest that no restriction is required for selection among nonionic low-osmolar ICMs.

Long-term safety and effectiveness of vonoprazan for prevention of gastric and duodenal ulcer recurrence in patients on nonsteroidal anti-inflammatory drugs in Japan: a 12-month post-marketing surveillance study

ABSTRACT Background This study assessed the safety and effectiveness of vonoprazan for prevention of duodenal and gastric ulcer recurrence in patients on long-term nonsteroidal anti-inflammatory drugs (NSAIDs) in routine clinical practice. Research design and methods This 12-month, prospective, observational study (145 sites, Japan, September 2016–April 2020) analyzed patients with a history of gastric or duodenal ulcer who started once-daily vonoprazan and were receiving NSAIDs for pain. The primary outcome was the incidence of adverse drug reactions (ADRs). Results Most patients (86.7% [1099/1268]) received vonoprazan for at least 6 months. Most patients (98.6% [1250/1268]) received the 10-mg dose of vonoprazan, 38.3% (486/1268) received cyclooxygenase-2 inhibitors, and 61.7% (782/1268) received other NSAIDs. The overall incidence of ADRs was 0.71% (9/1268). Most commonly reported ADRs were gastrointestinal (0.32%), nervous system (0.16%), and hepatobiliary system (0.16%) disorders. The overall incidence of gastric or duodenal ulcer recurrence was 1.04% (95% CI 0.56–1.78). Conclusions No new safety concerns were reported for vonoprazan for prevention of secondary ulcer or bleeding in patients receiving long-term NSAIDs. Vonoprazan was effective for preventing NSAID-related peptic ulcer recurrence in this real-world study. Trial registration ClinicalTrials.gov: NCT03214198; Japan Pharmaceutical Information Center Clinical Trials Information: JapicCTI-163436.

Safety and Effectiveness of Ustekinumab for Crohn's Disease in Japanese Post-marketing Surveillance in Biologic-Naive and -Experienced Conriemed.

To present the real-world evidence on the safety and effectiveness of ustekinumab (UST) through 52-week treatment for Crohn's disease (CD) under an analysis of post-market surveillance data in Japan. This prospective, post-marketing surveillance study was conducted in 341 patients from 91 medical facilities in Japan. Patients received UST 90 mg injected subcutaneously once every 12 weeks (or every 8 weeks if patients show weak effectiveness) after an induction dose given intravenously. Clinical response (100-point decrease in Crohn's Disease Activity Index [CDAI] score), clinical remission (CDAI score of <150), steroid-free clinical remission, C-reactive protein, endoscopy, physician global assessment, and adverse drug reactions (ADRs) were evaluated through 52 weeks. The overall rate of clinical remission was 49.2% at week 8 and 56.0% at week 52. The rate of clinical remission in biologic-naive patients was 75.9% and 66.7% at weeks 8 and 52, respectively, whereas the rate in biologic-experienced patients was 41.4% and 52.6% at weeks 8 and 52, respectively. For 52 weeks, the overall incidence of ADRs and serious adverse drug reactions (SADRs) was 11.7% and 6.7%, respectively. The most frequently reported SADRs was worsening of CD (1.8%). In multivariate analysis, ADRs incidence was significantly lower in patients with ileal involvement of CD (odds ratio = 0.25, 95% CI 0.07-0.85, P = .026), although disease location has no association with effectiveness of UST. The present study identified no new safety concerns and effectiveness for CD in Japanese patients treated with UST.

A study of the efficacy of sacubitril/valsartan plus dapagliflozin combination treatment in pulmonary arterial hypertension due to left heart disease.

To determine the efficacy of sacubitril/valsartan plus dapagliflozin in the treatment of patients with pulmonary arterial hypertension (PAH) due to left heart disease and to explore new treatment regimen for PAH due to left heart disease. This study is a randomized controlled trial (RCT) study of 120 patients with PAH due to left heart disease admitted to the cardiovascular department of our hospital from Dec. 2019 to Dec. 2021. The patients were randomized 1:1 to the study group and control group. All patients were given baseline treatments targeting left heart disease and symptoms of PAH. In addition to the baseline treatments, patients in the control group were given sacubitril/valsartan tablets, while patients in the study group were given sacubitril/valsartan tablets plus dapagliflozin tablets. After 6 months of treatment, parameters including left heart function and exercise tolerance, Hemodynamics (left ventricular end systolic diameter [LVSED], left ventricular end diastolic diameter [LVEDD], left ventricular ejection fraction [LVEF], 6 min walk distance (6MWD), mean pulmonary artery pressure (mPAP) and pulmonary artery systolic pressure (PASP)), vascular endothelial function (plasma endothelin (ET) -1 and nitric oxide [NO]), heart failure markers (plasma N-terminal pro-brain natriuretic peptide (NT-proBNP)], inflammatory factors (serum C reactive protein [CRP], interleukin (IL)-6, and tumor necrosis factor (TNF)-α], and adverse drug reactions (ADRs) were assessed in both groups. Both groups had reduced LVESD and LVEDD, increased LVEF, and extended 6MWD after 6 months of treatment. The improvements in these parameters were significantly greater in the study group than in the control group (all P < 0.05). In addition, both the mPAP and PASP showed a decrease, and the mPAP and PASP in the study group were lower than those in the control group (p<0.05). Furthermore, both groups had decreased plasma ET-1 and NT-proBNP but increased plasma NO after 6 months of treatment. The improvements in these parameters were significantly greater in the study group than in the control group (all P < 0.05). Serum CRP, IL-6 and TNF-α levels were decreased in both groups after 6 months of treatment, and were significantly lower in the study group than in the control group (all P < 0.05). There was no significant difference in the overall incidence of ADRs between the two groups (P > 0.05). Sacubitril/valsartan plus dapagliflozin in the treatment with PAH due to left heart disease can improve left heart function of patients by improving vascular endothelial functions and alleviating inflammation, which helps to reduce the PAH process. Therefore, this combination treatment is safe and effective in PAH due to left heart disease.

Change the preprocedural fasting policy for contrast-enhanced CT: results of 127,200 cases

ObjectivesTo analyze the relationship between the dietary preparation status prior to contrast-enhanced CT (CECT) and adverse drug reactions (ADR) and emetic complications.MethodsNon-emergency adult patients who underwent routine CECT in our hospital from January 2019 to December 2020 were retrospectively analyzed. Stratified dietary preparation regimens were implemented for different clinical scenarios. The relationship between actual dietary preparation status and ADR and emetic complications was analyzed.ResultsA total of 127,200 cases were enrolled, including 49,676 cases in the fasting group (57 years ± 13, 56.79% men) and 77,524 cases in the non-fasting group (60 years ± 13, 54.55% men). No statistical difference was found in the overall incidence of ADR (0.211% vs. 0.254%, p = 0.126) or emetic complications (0.030% vs. 0.046%, p = 0.158) between the two groups, and no aspiration pneumonia or death occurred. For patients with an ICM-ADR history, the ADR incidence in non-fasting group was significantly lower than fasting group (2.424% vs. 12.371%, p = 0.002). For patients with hypertension, injection dose ≥ 100 mL, injection rate ≥ 5 mL/s, and Iopromide 370 usage, non-fasting was associated with higher ADR incidence (p < 0.05). 36.67% of the patients experienced unnecessary excessive fasting in practice. Excessive fasting (≥ 10 h) and more water ingestion (≥ 500 mL) within 1 h prior to CECT were associated with higher ADR incidence (p < 0.05).ConclusionUnrestricted food ingestion would not increase the overall risk of ADR and emetic complications. For some special patient subgroups, non-fasting, excessive fasting, and more water ingestion were associated with higher ADR incidence.

Comparison of Clinical Efficacy and Safety of Metformin Sustained-Release Tablet (II) (Dulening) and Metformin Tablet (Glucophage) in Treatment of Type 2 Diabetes Mellitus

ObjectivesThis study investigated the clinical efficacy and safety of metformin hydrochloride sustained-release (SR) tablet (II) produced by Dulening and the original metformin hydrochloride tablet produced by Glucophage in the treatment of type 2 diabetes mellitus (T2DM).MethodsThis randomized, open and parallel controlled clinical trial consecutively recruited a total of 886 patients with T2DM in 40 clinical centers between May 2016 and December 2018. These patients were randomly assigned to the Dulening group (n=446), in which patients were treated with Dulening metformin SR tablets, and the Glucophage group (n=440), in which patients were treated with Glucophage metformin tablets, for 16 weeks. The changes in the levels of glycated hemoglobin (HbAc1) and fasting blood glucose (FBG) as well as weight loss were compared between these two groups. Also, the overall incidence of adverse drug reactions (ADRs) and the incidence of ADR of the gastrointestinal system observed in patients of these two groups were also compared.ResultsThere were no significant differences in demographic and basal clinical characteristics between these two groups. The Dulening and Glucophage groups showed comparable levels of decrease in HbA1c levels, FBG and weight loss after 12-week treatment (all p>0.05). The Dulening group had a significantly lower overall incidence of ADRs as well as gastrointestinal ADR than the Glucophage group.ConclusionsMetformin SR tablets (II) and the original metformin tablets exhibit similar therapeutic efficacy in the treatment of T2DM, but metformin SR tablets (II) has the significantly lower incidence of ADRs than the original metformin tablets.

A prospective study on prescribing pattern of drugs in geriatric patients in the department of medicine in a tertiary care center

Background: India stands at 3rd position with large elderly population in the world. Elderly population has special problems related to health, social support, and economic security. Comorbidities in elderly people are frequent, which require use of multiple medications which increases the number of inappropriate medications noncompliance, economic burden, adverse drug reactions (ADRs), and drug interactions. The overall incidence of ADR is two to three times higher due to physiological and pharmacological variations. Currently used screening tools for inappropriate prescription in old age are: Beers criteria and inappropriate prescribing in the elderly tool (IPET).Methods: A prospective observational study of elderly patients of either sex admitted in the medicine ward, conducted from May 2019-November 2019. A total of 102 prescriptions were collected and analysed. Data was analysed using Microsoft excel.Results: In this study most of the patients (67 out of 102) were in the age group 65-70 years with male population (73%) dominance. Most of the patient were admitted due to cardiovascular (35.84%) and respiratory system (14.15%) disorder. Anti-diabetics (17.64%) followed by anti-microbials (14.24%) were the most commonly prescribed medicines in this study. Our study revealed poly pharmacy in geriatric patients with an average number of drugs per prescription being 6.07. According to BEER’s criteria 3.47% of total drugs prescribed were inappropriateConclusions: In this study most of the patients had co morbid conditions, cardiovascular disease and diabetes being the common cause led to polypharmacy. A high number of potential prescription errors were found.

Incidence and cost of chemotherapy-induced adverse drug reactions among cancer patients in a charitable hospital

Introduction: Chemotherapy-induced adverse drug reactions (ADRs) are one of the major consequences of cancer therapy that affects patients’ quality of life, outcomes of the treatment, morbidity, and mortality and increases the economic burden. The study’s objective was to evaluate the incidence, causality, severity, and preventability and to calculate the direct medical cost of chemotherapy-induced ADRs among cancer patients. Materials and Methods: A prospective observational study was conducted for 8 months in patients above 18 years and receiving chemotherapy. ADRs were evaluated for their causality, severity, and preventability using different ADR assessment scales, and the economic burden for different ADRs was based on their direct medical costs. Results: A total number of 230 patients were enrolled in the study, out of which 84 patients developed 148 ADRs. Patients who received chemotherapy showed a higher incidence of ADRs in 45–55 years of age group (30.95%), females (69.04%), solid tumors (92.85%), stage III (55.95%), and double regimen (61.90%). Paclitaxel and carboplatin were reported to cause most ADRs, such as anemia (14.18%) and leucopenia (6.75%). ADRs were assessed using scales. As per the WHO-UMC scale, 59.4% ADRs were possible, followed by probable (39.2%). The majority of the ADRs were mild (52%) in severity. About 41.9% reactions were probably preventable, and 3.4% were definitely preventable. Conclusion: The overall incidence of ADRs was 36.52%. The direct medical cost incurred for the management of ADRs was 457.23 USD.

Acute Adverse Drug Reactions in Inpatient Children Diagnosed with Cancer over a 12-Year Period: A Report from a Single Center Study

Objectives: In this study, we aimed to assess the incidence rate of adverse drug reactions (ADR) to chemotherapeutic agents and related problems in hospitalized pediatric patients diagnosed with cancer who referred to Mahak hospital in Tehran. Methods: All information about 125 children younger than 18-years-old who experienced ADR during their chemotherapy period (from March 2008 to March 2020) in Mahak Pediatric Cancer Treatment and Research Center (MPCTR) was collected and analyzed in SPSS-25. Results: Most of patients (approximately 65%, n=81) were male and the mean age of both genders was approximately 6.6 years of old. In addition, leukemia was the most common cancer type followed by Central Nervous System tumor. In terms of adverse events, skin and subcutaneous disorders occurred in 74 cases of 125, whereas nervous system, Immune system disorders and musculoskeletal related disorders were the least common events each occurring only in four cases. According to Naranjo’s Probability Scale, most ADRs were evaluated as probable in relation with administrated drug (61.60%) and 56.80% of reactions were determined as mild. Furthermore, the commonest ADRcausative drugs were L-asparaginase followed by carboplatin (together more than 56% of all cases. Conclusion: The overall incidence of ADR amongst children diagnosed with cancer in our retrospective study was 3.68 %. Additionally, leukemia treatment regimen including L-asparaginase seems to be significantly vulnerable to induce ADRs in pediatric ward. Finally, there is a crucial need for monitoring pediatric patients during treatment process in order to reduce the risk of ADR occurrence. Key words: Adverse drug reaction, Chemotherapy, Childhood cancer, Pediatrics, CTCAE.

Self-Reported Allergy to Thyroid Replacement Therapy: A Multicenter Retrospective Chart Review

To determine patterns of adverse drug reactions (ADRs), including immediate drug hypersensitivity reactions (DHRs) and predictable ADRs, to thyroid replacement therapy (TRT). TRT is the treatment of choice for hypothyroidism. Levothyroxine (LT4) is among the most commonly prescribed medications in the United States, with over 70 million prescriptions annually. Documented immediate DHRs to TRT are rare, with only a few case reports. An 11-year (2008-2018) retrospective medical chart review of identified patients with self-reported allergy to TRT. ADRs to TRT were divided into immediate DHRs and predictable ADRs. A total of 466 patients were included in our study. We found an overall incidence of ADRs to TRT of 0.3%. Median age was 61.2 years; 85.8% were women, and 94.4% were Caucasian. The principal indication for TRT was autoimmune hypothyroidism (73.6%), followed by postsurgical hypothyroidism (17.4%) and subclinical hypothyroidism (6.7%). Predictable ADR manifestations to TRT were reported more commonly than DHR manifestations (57.5% vs. 42.5%, respectively). The most frequently reported of the former were palpitations (16.4%), nausea/vomiting (9.3%), and tremor (6.3%), while rash (23.8%), hives (9.5%), and pruritus (7.1%) were the most common regarding the latter. Fifty-six percent of the patients with an ADR to TRT tolerated an alternative TRT presentation. In our cohort, the majority of self-reported allergies to TRT were due to predictable ADRs rather than an immediate DHR. ADR = adverse drug reaction; DHR = drug hypersensitivity reaction; FDA = Food and Drug Administration; LT3 = liothyronine; LT4 = levothyroxine; SCAR = severe cutaneous adverse drug reaction; TRT = thyroid replacement therapy.

Tu1171 INCIDENCE OF ADVERSE DRUG REACTIONS OF POLYETHYLENE GLYCOL ELECTROLYTES POWDER: THE ANALYSIS OF REPORTS IN CHINA

Since 2018, the National Medical Products Administration of China has issued a notice on the Direct Reporting of Adverse Drug Reactions (ADRs) by Marketing Authorization Holders (MAH), which has ushered in a new era in the reporting of ADRs in China. Objective: Niflec (Polyethylene Glycol Electrolytes Powder, PEG-ELP) is one of the most widely used oral intestinal lavage preparation agents in China. The purpose of this study is to analyze the incidence of Niflec ADRs reported in the database of ADR monitoring system in the first six months after the MAH reporting policy, and to evaluate the clinical safety of Niflec. The reports of ADRs caused by Niflec were screened out from the database of ADR monitoring system, and they were analyzed by gender, age, primary disease, concomitant drugs, occurrence time, history of allergy, ADR types, causality, and severity. From December 15, 2018 to June 15, 2019, thirty-two ADR cases were reported, including one serious adverse event. The adverse reactions were more in patients aged 60 and over (50.0%) and more in female (71.9%). Only one patient had a clear history of drug allergy. The main adverse reactions occurred in the gastrointestinal system (53.1%) or skin and mucous membrane (34.4%). The top three manifestations were vomiting, nausea and rash. Most of the ADRs were observed within 30 minutes after the first use, accounting for 37.5%. Concomitant drugs were taken by 9.4% of the patients. The one serious adverse event was intestinal obstruction with shock. According to Pharmaceutical DataBase (PDB) data, the market size of Niflec in China was approximately 2 million bags in the first and second quarter of 2019. The number of drug users was estimated to be 679,896. Based on the above analysis, the overall incidence of ADR of Niflec was relatively low, less than 5 per 100,000 patients. The total incidence of serious ADR was less than 1.5 per million, which was very rare. All patients recovered or improved after proper treatments. The safety of PEG-ELP is confirmed by this study. However, it is still necessary to pay attention to the correct preparation and proper use. The bowel preparation personnel should be alert to monitor ADRs, especially on patients aged 60 and over, and take corresponding measures if any of these reactions are encountered.

Effectiveness and tolerability of tramadol versus diclofenac in treatment of knee osteoarthritis: A comparative clinical study

Background: Osteoarthritis (OA) is a progressive joint disease. It causes wear and tear of the articular cartilage of the joint. It is painful and symptoms include joint pain, stiffness, and tenderness. Performing daily life activities gets affected over time. Aim and Objectives: The aim of the present study was to compare the effectiveness and tolerability of tramadol versus diclofenac in treating chronic pain due to knee OA and to determine Adverse drug reactions (ADRs) with the use of the drugs. Materials and Methods: Consecutive patients of OA reporting to our hospital with chronic knee pain aged 45–65 years were divided into two treatment groups, tramadol and diclofenac groups, and received the tramadol drug and diclofenac drug orally with doses of 50 mg and 75 mg 2 times a day, respectively, for 8 weeks. Overall improvement was evaluated through various parameters. Results: There was a 16.73% decrease in time taken to walk 100 feet in the diclofenac group and an 18.30% decrease in the tramadol group. There was a 42.85% decrease in pain score at rest in diclofenac and a 50.72% decrease in the tramadol group. A decrease in pain score during active movement was 32.4% in diclofenac and 44.8% decrease in the tramadol group. The overall incidence of ADRs reported in the study was n = 8 (16%) in the tramadol group and n = 13 (26%) in the diclofenac group. Conclusions: Tramadol was superior to diclofenac for reducing knee joint pain, stiffness, tenderness, and difficulty in daily performing tasks. There was a significant improvement in the standard of life in patients suffering from knee OA when treated with tramadol.

Safety and effectiveness of tadalafil in patients with pulmonary arterial hypertension: Japanese post-marketing surveillance data

Objective: To evaluate the long-term safety and effectiveness of tadalafil in patients with pulmonary arterial hypertension (PAH) in real-world clinical practice.Methods: This prospective, multicenter, noninterventional, post-marketing surveillance included patients with PAH who were observed for up to 2 years after initiation of tadalafil. Safety was assessed by analyzing the frequency of adverse drug reactions (ADRs), discontinuations due to adverse events (AEs), and serious adverse drug reactions (SADRs). Effectiveness measurements included the assessment of the change in World Health Organization (WHO) functional classification of PAH, 6-minute walk test, cardiac catheterization, and echocardiography.Results: Among 1676 patients analyzed for safety, the overall incidence of ADRs was 31.2%. The common ADRs (≥1.0%) were headache (7.0%), diarrhea (1.9%), platelet count decreased (1.8%), anemia, epistaxis, and nausea (1.6% each), flushing (1.3%), hepatic function abnormal (1.1%), hot flush, and myalgia (1.0% each). The common SADRs (≥0.3%) were cardiac failure (0.7%), interstitial lung disease, worsening of PAH, and platelet count decreased (0.3% each). Among 1556 patients analyzed for effectiveness, the percentages of patients with improvement of WHO functional class at 3 months, 1 year, and 2 years after the initiation of tadalafil, and last observation were 17.1%, 24.8%, 28.9%, and 22.5%, respectively. At all observation points (except pulmonary regurgitation pressure gradient at end diastole at 3 months), the mean 6-minute walk distance, cardiac catheterization, and echocardiogram measurements showed statistically significant improvement.Conclusion: This surveillance demonstrated that tadalafil has favorable safety and effectiveness profiles for long-term use in patients with PAH in Japan.

Magnitude of Antiretroviral Drug Toxicity in Adult HIV Patients in Ethiopia: A cohort study at seven teaching hospitals.

The introduction of antiretroviral therapy (ART) has resulted in significant mortality reduction and improvement in the quality of life. However, this has come at a cost of increased drug toxicity. The objective of this study was to assess the patterns and predictors of ART toxicity in adult HIV patients in Ethiopia. This is a prospective cohort study conducted at seven teaching hospitals between September 2009 and December 2013 involving 3921 HIV patients on ART. Adverse drug reactions (ADR) due to ART were identified based on clinical assessment and/or laboratory parameters. Multivariable random effects Poisson regression analysis was used to identify factors independently associated with toxicity. ADR due to ART drugs was reported in 867 (22.1 %) of the participants; 374 (9.5%) had severe forms. About 87% of reported toxicities were limited to three organ systems - the skin, nervous system and blood. The overall incidence of ADR was 9 per 100 person years. About a third of toxicities occurred during the first six months after ART initiation with the incidence rate of 22.4 per 100 person years. Concomitant anti-tuberculosis treatment was the strongest independent predictor of toxicity. ADR was found to be highly prevalent in HIV patients on ART at tertiary hospitals in Ethiopia. Most of these conditions occurred early after ART initiation and in those with concomitant anti-tuberculosis treatment. Thus, routine monitoring of patients on ART should be strengthened with particular emphasis in the first 6 months. Strategies should also be devised to replace older and more toxic agents with newer and safer drugs available.

Standard approach to antiepileptic drug therapy in focal epilepsy at a tertiary care hospital in Bengaluru: A retrospective cohort study

Background: Epilepsy is a common neurological disorder which demands long-term therapy and thereby carries a huge medical, social, psychological, and economic impact on a developing country. In India, it is estimated that 6-10 million people suffer from epilepsy which accounts for 1/5th of the global epilepsy burden. About 2/3rd of the newly diagnosed epilepsies are focal. The overall aim of treating epilepsy should be complete control of seizures, without causing any untoward reaction due to the antiepileptic therapy. Aims and Objectives: The primary objectives are to analyze the pattern of antiepileptic drugs (AEDs) used in focal epilepsy and to assess the retention rate (success rate) at 1-year follow-up. The secondary objectives are to evaluate the effectiveness of substitution versus add-on in treatment failure cases and to assess the profile of adverse drug reactions (ADRs) reported. Materials and Methods: This is a retrospective cohort study spanning from January 2009 to January 2014. Patients diagnosed as focal epilepsy attending Neurology outpatient department attached to BMCRI were included in the study. Data were collected through the integration of case records to retrieve the information regarding the demographic and clinical details, AEDs, and ADRs. Retention rate with initial AED was determined at the end of 1-year follow-up. Efficacy was assessed in terms of adequate seizure control between substitution and add-on therapies in all treatment failure cases. The results were analyzed by descriptive statistics, Chi-square, and Fisher’s exact tests. Results: Out of 134 patients, 57% were males and 43% were females. The age ranged from 14 to 82 years. Monotherapy accounted for 67% of the total epileptic patients, in which 42% continued with initial, 25% substituted to alternative AED, and 33% of them required add-on therapy. The most common AEDs prescribed as monotherapy were carbamazepine (35.07%) and phenytoin (11.94%) and as add-on were carbamazepine with valproate (4.47%) and carbamazepine with phenytoin (4.47%). Carbamazepine showed higher retention rate among all initial AEDs at the end of 1-year follow-up (odds ratio: 2.1, 95% confidence interval: 1.03-4.24). On Fisher’s exact test, substitution therapy was better than add-on in adequate seizure control (P = 0.026). The overall incidence of ADRs was 21.6%. Drowsiness and agitation and tiredness were the common ADRs reported. Conclusion: Despite the availability of newer AEDs, the domain of pharmacotherapy in focal epilepsy is still dominated by conventional AEDs. Carbamazepine has showed better retention rate at 1-year follow-up. Our study suggests that substitution therapy is a better alternative than add-on therapy in all treatment failure cases with initial AEDs.

New Ways of Detecting ADRs in Neonates and Children.

Severe adverse drug reactions (ADRs) cause 5-7% of all hospital admissions, an estimated 2,000,000 severe reactions, and over 100,000 deaths each year in the USA. A recent systematic review indicated that the overall incidence of ADRs was 11% in hospitalized children and 1% in outpatients. Detecting ADRs in neonates and children is challenging, particularly because there are fewer clinical trials involving children than adults and drug use in children is common without a labeled indication. Ontogeny and significant physiological changes related to age have an impact on metabolic drug clearance and pharmacodynamics in children compared to adults, as well as on drug action. A variety of strategies have been developed for the identification and further evaluation of ADRs, starting from case reports and advancing into more structured methodologies, such as active surveillance, for accumulating the necessary information. While each approach has merit, a comprehensive surveillance approach with different methods is required to monitor drug safety in the post-market period. Among the methods that have shown value in neonates and children are anecdotal reporting, voluntary organized reporting, prescription event monitoring, pharmacoepidemiology using administrative databases, and active surveillance. There is an urgent need to improve the evaluation of paediatric drug safety in the pre- and post-market phases of drug evaluation in order to better predict in whom serious harm may occur and better ensure the safe use of drugs for neonates and children.

Pharmacovigilance study of Ayurvedic medicine in Ayurvedic Teaching Hospital: A prospective survey study.

Introduction:Though Ayurveda is practiced in the Indian subcontinent since centuries, there is a paucity of systematic documentation related to the occurrence of adverse drug reactions (ADR) and other issues regarding the safety of Ayurveda medicines.Aim:To monitor and analyze the pattern and frequency of ADR to Ayurvedic medicines in an Ayurvedic hospital setup.Materials and Methods:In this prospective study, ADR monitoring was done in KLE Ayurveda Secondary Care Hospital, Belgaum, Karnataka, India by spontaneous and intensive monitoring technique for a span of 1-year (June 2010 to May 2011). Data pertaining to patient demography, drug and reaction characteristics, organ system involved and reaction outcomes were collected and evaluated. The reaction severity and predisposing factors were also assessed.Results:In a span of one year, 84 adverse drug events were reported out of which 52 confirmed as ADR. The overall incidence of ADR in the patient population was 1.14%, out of which 23 (44.23%) were related to Panchakarma (detoxification process), 13 (25.00%) related to the herbal formulations and 06 (11.53%) were of Rasa Aushadhi (mineral or herbo-mineral formulations). The commonly affected organ systems were gastrointestinal system 24 (46.15%) and skin 15 (28.84%). The majority of the reactions were moderate 30 (57.69%) to mild 20 (38.46%) in severity. Most patients recovered from the incidence.Conclusion:The present work has documented the incidence and characteristic of ADR to Ayurvedic medicine in a typical Ayurveda hospital setup. This will help in developing various strategies for boosting pharmacovigilance in Ayurveda, thereby ensuring safer use of Ayurveda medicines.

Pattern Of Use Of Highly Active Antiretroviral Therapy Regimens And Pattern Of Occurrence Of Adverse Drug Reactions In An Indian Human Immunodeficiency Virus Positive Patients.

ABSTRACT Background: In India, Human immunodeficiency (HIV) infected patients with highly active antiretroviral therapy (HAART) are at higher risk of developing adverse drug reactions (ADRs). Objectives: The aim of this study was to characterize the pattern of use of HAART, occurrence, incidence, severity and causality of ADRs to HAART in Indian HIV positive patients. Methods: This was a prospective observational study conducted between August 2009 and May 2012. Enrolled HIV positive patients were intensively monitored for ADRs with fixed dose antiretroviral therapy as per National AIDS Control organization (NACO).World Health Organization (WHO) definition of ADR was adopted to detect ADRs to HAART and classified based on WHO adverse reaction terminologies. Naranjo’s scale was used for causality assessment of ADRs. Preventability was assessed using Thornton and Schuman criteria and severity was assessed using the modified Hart wig and Siegel scale. Pattern of ADRs was assessed with patient demographics, ADRs characteristics, and pattern of drug and reaction characteristics. P-value <0.05 was considered as statistically significant. Results: A total of 426 ADRs to HAART were evaluated from 1982 HIV positive patients during the study period. The overall incidence of ADRs to HAART was 21.4%. Significant difference was seen in the incidence of ADRs in the age group of 41-60 years (p <0.001), CD4+T-cell counts of 350-500 cells/μl (p <0.001), females (p <0.001). Three fatal ADRs of with cutaneous drug eruptions of Steven Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) was 1.1%. Anemia (31.7%) accounted for majority of the reports followed by vomiting (15.5%), skin rash (12.9%) and peripheral neuropathy (10.7%). The suspected drug was withdrawn for the management of the ADRs in majority (27.9%) of the reports. Higher incidence rate of ADRs was noted with lamivudine (3TC) + nevirapine (NVP) + stavudine (D4T) (22.9%). In, naranjo's causality assessment, majority of the ADR reports were rated as possible (69%). Symptomatic treatment for ADRs was given in 91.8% of the reports and 86.4% of the reports the patient recovered from the suspected adverse reaction at the time of evaluation. Conclusion: In India, occurrence of ADRs to HAART in HIV infected patients was found to be higher with zidovudine induced anemia (31.7%). The higher percentage of ADRs to HAART was seen with female patients, age 41-60 years; CD4+ T-cell counts 350-500 cells/μl. Physician must focus for monitoring all lab investigations for early detection and prevention of adverse effects associated with HAART.

Evaluation of adverse drug reactions in medical intensive care units

Patterns of adverse drug reactions (ADRs) in the medical intensive care unit (MICU) were analysed, and signals for detecting ADRs were developed from the analysis. A retrospective study was conducted in MICU wards at a tertiary care teaching hospital in Seoul, Korea. The areas included one general MICU and one cancer centre MICU. Two pharmacists evaluated ADRs in terms of length of stay, causality, severity, preventability, types, related organs, and incidence. Differences in ADR perception rates between physicians and pharmacists were also evaluated. ADR cases detected through the evaluation were reviewed to develop specific alerting signals for ICU ADRs. The study group included 346 patients admitted to the ICU over 4 months. The overall incidence of ADRs was 32%. ICU length of stay is closely related to ADRs (p = 0.014). Most ADR cases were mild, temporary, and harmful to the patient. Twenty percent of ADRs were preventable, and 74% were type A. Of the ADRs, 70% were noted by physicians; 80% required intervention. The most commonly implicated drug was amphotericin B, and the clinical presentation was a haematologic reaction. Data on the time required for pharmacists to identify ADRs indicated that they were not slower than physicians. Six signals for early detection of the ADRs were developed. The overall ADR incidence in the MICU was about one-third, and the length of stay of the ADR group was longer than that of those without this experience. Automated signal generation was developed. It seemed to be a valuable tool for faster and more efficient patient management, and possibly prevention of ADRs. A future study should scientifically evaluate the clinical relevance of this tool.