Adverse Drug Reaction Profile Research Articles

Preferences for Prophylactic Oral Antibiotic Use in Dermatologic Surgery: A Multicenter Discrete Choice Experiment.

Antibiotics are often prescribed after dermatologic surgery for infection prophylaxis, but patient preferences about prophylactic antibiotics are not well understood. To understand patient preferences about taking antibiotics to prevent surgical site infection (SSI) relative to antibiotic efficacy and antibiotic-associated adverse drug reactions. Multi-center, prospective discrete choice experiment (DCE). Three hundred thirty-eight respondents completed the survey and DCE. 54.8% of respondents preferred to take an antibiotic if it reduced the SSI rate from 5% to 2.5% and if the risk of adverse drug reactions was low (1% risk gastrointestinal upset, 0.5% risk itchy skin rash, 0.01% risk emergency department visit). Even if an antibiotic could eliminate SSI risk (0% risk SSI) and had a low adverse drug reaction profile, 26.7% of respondents prefer not to take prophylactic oral antibiotics. Risk-benefit thresholds for taking antibiotics to prevent SSI vary widely. Clinical trials are needed to better characterize the effectiveness and risks of oral antibiotic SSI prophylaxis to guide decision-making. Future studies should also evaluate whether shared decision-making can improve the patient experience.

Adverse drug reaction monitoring in patients of hypertension at a tertiary care hospital, Aurangabad, Maharashtra, India

Background: Hypertension is one of the highest prevailing diseases worldwide. Due to long term therapy antihypertensive drugs are commonly associated with adverse drug reactions (ADRs). Therefore, the study was conducted with the objective to examine the incidence of different types of ADRs in drug treated hypertensive patients.Methods: Present study was a prospective cross sectional observational study carried out in the outpatient of department of medicine of MGM hospital, a tertiary care teaching hospital, in Aurangabad. 320 diagnosed hypertensive patients were studied. Questionnaire was asked and their prescription were analysed and follow up was done.Results: Among 320 patient’s 75 patients were reported ADR. Males accounted for higher percent of ADRs 46 (61%) than females 29 (38.6%). Most of the patients 147 (55.9%) were on mono therapy. Calcium channel blocker was the frequently used class of drug, showed maximum number of ADR (30.6%) followed by ACE inhibitor (28%) and ARB (21.3%). As per WHO-UMC scale, type of reactions and their percentage were as certain (9.3%), Probable/ Likely (64%), possible (22.6%), and unlikely (4%). According to Naranjo scale most of the reactions were possible (64%). severity assessment is done by Hartwig and Siegel scale. No lethal ADR were reported. 4% reactions were severe, 32% were of moderate category and 64% were mild reactions.Conclusions: Such type of studies are helpful in selection of appropriate medicines for hypertensive patients, enhancing patient adherence with the therapy by selecting medicines of lesser ADR profile, reducing unnecessary economic burden to the patients due to unwanted effects of the therapy.

Gastrointestinal Adverse Drug Reaction Profile of Etanercept: Real-world Data From Patients and Healthcare Professionals.

We aimed to describe the nature and frequency of gastrointestinal adverse drug reactions (GI-ADRs) of etanercept (ETN) using patient-reported and healthcare professional (HCP)-registered data and compared this frequency with the GI-ADR frequency of the widely used tumor necrosis factor-α inhibitor adalimumab (ADA). Reported GI-ADRs of ETN for rheumatic diseases were collected from the Dutch Biologic Monitor and DREAM registries. We described the clinical course of GI-ADRs and compared the frequency with ADA in both data sources using Fisher exact test. Out of 416 patients using ETN for inflammatory rheumatic diseases in the Dutch Biologic Monitor, 25 (6%) patients reported 36 GI-ADRs. In the DREAM registries 11 GI-ADRs were registered for 9 patients (2.3%), out of 399 patients using ETN, with an incidence of 7.1 per 1000 patient-years. Most GI-ADRs consisted of diarrhea, nausea, and abdominal pain. GI-ADRs led to ETN discontinuation in 1 patient (4%) and dose adjustment in 4 (16%) in the Dutch Biologic Monitor. Eight GI-ADRs (73%) led to ETN discontinuation in the DREAM registries. The frequency of GI-ADRs of ETN did not significantly differ from GI-ADRs of ADA in both data sources (Dutch Biologic Monitor: ETN 8.7% vs ADA 5.3%, P = 0.07; DREAM: ETN 2.8% vs ADA 4.7%, P = 0.16). Most GI-ADRs associated with ETN concerned gastrointestinal symptoms. These ADRs may lead to dose adjustment or ETN discontinuation. The frequency of ETN-associated GI-ADRs was comparable to the frequency of ADA-associated GI-ADRs. Knowledge about these previously unknown ADRs can facilitate early recognition and improve patient communication.

Comparative Study of Different Oral Iron Preparations in Females of Reproductive Age Group

Background: Anemia (anemia) is a decrease in the total amount of red blood cells (RBCs) or hemoglobin in the blood, or a lowered ability of the blood to carry oxygen. The commonness of iron inadequacy is high in all age bunch females. Around 32.4% of ladies have mellow iron deficiency, 14.19% ladies have direct sickliness, 2.2% have serious weakness.
 Objective: The aim of the study is to compare the efficacy and safety profile of oral iron formulations in iron deficiency anemia.
 Methods: A cross sectional study in patients with anemia receiving oral ferric ammonium citrate, folic acid, vitamin B12and iron hydroxide respectively was included. The patients were followed up once in 0 day, end of week, 1 month, for 3 months and observed for hematological improvement and adverse drug reactions (ADRs). Total 350 anemic patient were included in the study.
 Results: The data analyzed in 185 patients received ferric ammonium citrate, folic acid, 165 received, iron hydroxide,folic acid, vitamin B12 have significantly improved mean hemoglobin and anemia indices at the end of study, however, there was no significant differences between the groups when compared. “All four formulations showed similar ADR profile, there was no significant difference in adverse reactions.’’
 Conclusion: Ferric ammonium citrate can be considered as best cost-effective choice for treatment of irons deficiency anemia.

Characteristics of people on long-acting injectable antipsychotics in Australia: Data from the 2010 National Survey of High Impact Psychosis.

This study investigates (1) the proportion of people with psychosis who are on long-acting injectable antipsychotics; (2) the difference in the demographic, clinical, substance use and adverse drug reaction profiles of people taking long-acting injectables compared to oral antipsychotics; and (3) the differences in the same profiles of those on first-generation antipsychotic versus second-generation antipsychotic long-acting injectables. Data were collected as part of the Survey of High Impact Psychosis. For this study, participants with diagnoses of schizophrenia or schizoaffective disorder who were on any antipsychotic medication were included (N = 1049). Nearly a third (31.5%) of people with psychosis were on long-acting injectables, of whom 49.7% were on first-generation antipsychotic long-acting injectables and 47.9% were on second-generation antipsychotic long-acting injectables. This contrasts with oral antipsychotics where there was a higher utilisation of second-generation antipsychotics (86.3%). Of note, compared to those on the oral formulation, people on long-acting injectables were almost four times more likely to be under a community treatment order. Furthermore, people on long-acting injectables were more likely to have a longer duration of illness, reduced degree of insight, increased cognitive impairment as well as poor personal and social functioning. They also reported more adverse drug reactions. Compared to those on first-generation antipsychotic long-acting injectables, people on SGA long-acting injectables were younger and had had a shorter duration of illness. They were also more likely to experience dizziness and increased weight, but less likely to experience muscle stiffness or tenseness. Long-acting injectable use in Australia is associated with higher rates of community treatment order use, as well as poorer insight, personal and social performance, and greater cognitive impairment. While long-acting injectables may have the potential to improve the prognosis of people with psychosis, a better understanding of the choices behind the utilisation of long-acting injectable treatment in Australia is urgently needed.

ADVERSE DRUG REACTIONS IN PEDIATRIC PATIENTS IN A TERTIARY CARE HOSPITAL IN KOLLAM

Objective: Adverse drug reactions have not been as thoroughly studied in children as they have in adults. Extrapolation of efficacy, dosing regimens, and ADRs from adult data are inappropriate owing to developmental changes in physiology and drug handling. There is a lack of local data regarding the potential risk of ADRs in pediatric patients. Objective of this study is to identify the adverse drug reaction (ADR) profile in pediatric patients.
 Methods: In this cross-sectional study, 450 children attending the pediatric inpatient and outpatient department were selected, and the CDSCO reporting form for suspected ADR reporting forms was collected from those who had any adverse events by the consulting pediatrician. Later, this form was analyzed for the details for ADRs and assessed for causality, severity, and preventability using Naranjo’s algorithm, Hartwig and Siegel scale, and modified Schumock and Thornton scale of adverse drug reactions.
 Results: The cross-sectional study revealed a prevalence of 12.89%. Antibiotics caused more ADRs than any other group of drugs. Dermatological ADRs were the most common. Most ADRs were not preventable and were of moderate severity. The causality assessment showed that most ADRs were possible category.
 Conclusion: The ADRs are often unrecognized. We need more strict monitoring for early detection, treatment, and more importantly prevention of these events in the future. For that, more awareness programs, CMEs and teamwork are extremely important among the caregivers.

A Profile of Adverse Drug Reactions in a Teritiary Care Teaching Hospital and Associated Factors

Objective: The present study was conducted to identify, analyze the causality, and severity of adverse drug reactions and to find out the factors associated with ADR related factors. Adverse effects of drugs are identified as one of the main reason for increasing in-patient number in the hospital. This has become financial burden and also rise in mortality rate in society. The main purpose of the pharmacovigilance program is to identify the risks linked with the use of drugs. This study may be useful to identify and prevent adverse effects caused by drugs to increase the quality of life and ability of doctors to treat consequences of ADRs more effectively. The main aim of the present study was to explore and identify adverse effects caused by drugs and to improve patient safety with pharmacovigilance activities. Method: An observational study was conducted as part of Pharmacovigilance program for 14 months (January 2018 - Feb 2019). ADRs reported from hospital were filled into Suspected ADR forms - CDSCO forms. Causality assessment was done based on WHO- UMC causality scale and severity was assessed using Hartwig-Siegel scale. By taking history of the patient, and by regular monitoring of the inpatients, the causative factors for ADR related hospital admissions were evaluated. Results: Total 145 ADR reports were analyzed. Most of the ADRs were observed in females (60%). Majority of ADRs were caused by NSAIDs (32.4%), followed by antimicrobials (20%). Most common organ systems involved was skin (38%). Causality assessment showed 85.5% ADRs as probable. 18.6% of ADRs were of severe type and 51% moderate. ADR related hospital admissions were found in 53 cases (36.5%) and 92 cases of ADRs occurred during hospitalization (63.4%). Conclusion: The study generated a data of ADRs that is useful to the clinicians for optimum and safe use of drugs in day to day practice and help in creating ‘P’ drug list. The major reasons for ADR related hospital admissions are OTC and non-compliance. Hence a constructive Pharmacovigilance to minimize ADR related hospitalization, treatment cost, morbidity and mortalities are the need of the hour.

Potential Alteration of Statin-Related Pharmacological Features in Diabetes Mellitus.

Objective Type 2 diabetes mellitus is a chronic metabolic disease caused by insulin resistance or insulin deficiency resulting in elevated blood glucose levels. Poorly controlled diabetes is associated with the development of cardiovascular disease and dyslipidemia. 3-Hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statin) are an important class of therapeutic agents used to control hyperlipidemia and prevent cardiovascular disease in diabetic and nondiabetic patients. Since the effect of diabetes on the pharmacokinetics and pharmacodynamics of drugs and toxins has been shown, the aim was to review previous studies on the efficacy of statins such as atorvastatin, simvastatin, pravastatin, pitavastatin, fluvastatin, and rosuvastatin in clinical and preclinical studies in both diabetic and nondiabetic groups. Method For this purpose, Web of Science, PubMed, Scopus, and Google Scholar databases were reviewed, and related English articles published until October 2020 were included in this review article. Results The findings revealed that diabetes affected statin effectiveness through changes in pharmacokinetic parameters such as clearance and biotransformation biomarkers at mRNA and protein levels. Plasma and serum concentrations of statins were accompanied by alteration in cellular activities including oxidative stress, Akt inhibition, and endothelial nitric oxide synthase (eNOS) and phosphorylation that were reflected in changes in the adverse drug reaction profile of the differing statins. Conclusion Given that dyslipidemia frequently accompanies diabetes and statin therapy is common, more clinical studies are needed regarding the effects of diabetes on the effectiveness of these drugs.

Do dimethyl fumarate and nicotinic acid elicit common, potentially HCA2 -mediated adverse reactions? A combined epidemiological-experimental approach.

Dimethyl fumarate and nicotinic acid activate the hydroxy-carboxylic acid receptor 2 (HCA2 ) and induce flushing. It is not known whether HCA2 mediates other adverse drug reactions (ADRs) to these two substances. This study aims to compare ADRs associated with dimethyl fumarate and nicotinic acid, and to discuss whether they are HCA2 -mediated. We identified spontaneous reports of suspected ADRs to dimethyl fumarate and nicotinic acid in the European Adverse Drug Reaction Database (EudraVigilance). These reports were analysed at different hierarchical levels of the Medical Dictionary for Regulatory Activities (MedDRA). In addition, we screened murine organs for HCA2 expression. Similarities in the ADR profile of dimethyl fumarate and nicotinic acid included "gastrointestinal signs and symptoms" (odds ratio [OR] 0.8 [0.6-1.1]), "hepatobiliary investigations" (OR 1.3 [0.7-2.5]) and "anxiety disorders and symptoms" (OR 0.9 [0.3-2.2]) in High Level Group Terms; "diarrhoea (excluding infective)" (OR 1.2 [0.7-1.8]) and "liver function analyses" (OR 1.3 [0.7-2.6]) in High Level Terms; and "diarrhoea" (OR 1.2 [0.7-2.0]) and "vomiting" (OR 0.9 [0.4-1.7]) in Preferred Terms. In analogy, HCA2 was expressed in the gastrointestinal tract, liver and central nervous system (CNS) of murine organs. A discrepant ADR profile was seen for "lymphopenia" (n = 777) at the preferred term level (only reported for dimethyl fumarate) and "blood glucose increased" (more often reported for nicotinic acid; OR 0.1 [0.0-0.5]). The gastrointestinal ADRs common to both substances may be mediated by HCA2 . Other ADRs not common to both substances are compound or indication-specific reactions and likely do not involve HCA2 .

Multi-Drug Featurization and Deep Learning Improve Patient-Specific Predictions of Adverse Events.

While the clinical approval process is able to filter out medications whose utility does not offset their adverse drug reaction profile in humans, it is not well suited to characterizing lower frequency issues and idiosyncratic multi-drug interactions that can happen in real world diverse patient populations. With a growing abundance of real-world evidence databases containing hundreds of thousands of patient records, it is now feasible to build machine learning models that incorporate individual patient information to provide personalized adverse event predictions. In this study, we build models that integrate patient specific demographic, clinical, and genetic features (when available) with drug structure to predict adverse drug reactions. We develop an extensible graph convolutional approach to be able to integrate molecular effects from the variable number of medications a typical patient may be taking. Our model outperforms standard machine learning methods at the tasks of predicting hospitalization and death in the UK Biobank dataset yielding an R2 of 0.37 and an AUC of 0.90, respectively. We believe our model has potential for evaluating new therapeutic compounds for individualized toxicities in real world diverse populations. It can also be used to prioritize medications when there are multiple options being considered for treatment.

A systematic review and meta-analysis of the association between clozapine and norclozapine serum levels and peripheral adverse drug reactions.

Clozapine is the most effective antipsychotic for treatment-refractory schizophrenia for reducing positive psychotic symptoms. It is associated with a reduction in hospitalisation and overall mortality. In spite of this, clozapine remains underutilised due to its complex adverse drug reaction (ADR) profile. This systematic review aims to investigate the association of clozapine and norclozapine serum levels, and peripheral ADRs. Studies were searched from four electronic databases (PubMed, EMBASE, PsycINFO and CINAHL) from inception to 12 June 2020. Studies were included if they had adult patients, provided data on steady-state trough clozapine or norclozapine levels and reported on clozapine-associated ADRs. Pregnant women, case reports and series were excluded. A statistically significant correlation was found for clozapine serum levels and triglycerides (n = 70; r = 0.303, 95% CI 0.0119-0.546, p = 0.042), heart rate (n = 137; r = 0.269, 95% CI 0.0918-0.486, p = 0.035), and overall combined ADRs (n = 160; r = 0.264, 95% CI 0.110-0.405, p = 0.001), but not for absolute neutrophil count (n = 223; r = - 0.164, 95% CI - 0.529-0.253, p = 0.444) or total white cell count (n = 18; r = 0.0176, 95% CI - 0.203-0.237, p = 0.878). Interestingly, norclozapine serum levels were found to be statistically correlated to triglycerides (n = 120; r = 0.211, 95% CI 0.0305-0.378, p = 0.022), total cholesterol (n = 120; r = 0.272, 95% CI 0.0948-0.432, p = 0.003) and weight gain (n = 118; r = 0.208, 95% CI 0.0261-0.377, p = 0.025). Heart rate, triglycerides and combined ADRs are significantly correlated with clozapine levels, and triglycerides, total cholesterol and weight gain with norclozapine levels. Future prospective, randomised controlled studies are needed to identify the cause-effect relationship between clozapine levels and peripheral ADRs.

Nobody ever questions-Polypharmacy in care homes: A mixed methods evaluation of a multidisciplinary medicines optimisation initiative.

Nurse-led monitoring of patients for signs and symptoms associated with documented 'undesirable effects' of medicines has potential to prevent avoidable harm, and optimise prescribing. The Adverse Drug Reaction Profile for polypharmacy (ADRe-p) identifies and documents putative adverse effects of medicines commonly prescribed in primary care. Nurses address some problems, before passing ADRe-p to pharmacists and prescribers for review, in conjunction with prescriptions. We investigated changes in: the number and nature of residents' problems as recorded on ADRe-p; prescription regimens; medicines optimisation: and healthcare costs. We explored aetiologies of problems identified and stakeholders' perspectives. In three UK care homes, 19 residents completed the study, December 2018 to May 2019. Two service users, three pharmacists, six nurses gave interviews. This mixed-method process evaluation integrated data from residents' ADRe-ps and medicines charts, at the study's start and 5-10 weeks later. We recruited three of 27 homes approached and 26 of 45 eligible residents; 19 completed ADRe-p at least twice. Clinical gains were identified for 17/19 residents (mean number of symptoms 3 SD 1.67, range 0-7). Examples included management of: pain (six residents), seizures (three), dyspnoea (one), diarrhoea (laxatives reduced, two), falls (two of five able to stand). One or more medicine was de-prescribed or dose reduced for 12/19 residents. ADRe administration and review cost ~£30 in staff time. ADRe-p helped carers and nurses bring residents' problems to the attention of prescribers. ADRe-p relieved unnecessary suffering. It supported carers and nurses by providing a tool to engage with pharmacists and prescribers, and was the only observable strategy for multidisciplinary team working around medicines optimisation. ADRe-p improved care by: a) regular systematic checks and problem documentation; b) information transfer from care home staff to prescribers and pharmacists; c) recording changes. NLM Identifier NCT03955133; ClinicalTrials.gov.

An observational study on adverse drug reaction profile in patients on long-term treatment with proton pump inhibitors

An observational study on adverse drug reaction profile in patients on long-term treatment with proton pump inhibitors

Adverse drug reactions of anti-infective drugs for systemic use in Morocco: Pharmaco-Epidemiological study 2008-2016

Analyzing the spontaneous reports of adverse drug reactions (ADRs) of anti-infective drugs for systemic use is an essential pillar in creating valuable database in pharmacovigilance.Therefore, the main of this study is to describe the epidemiological and clinical properties, as well as, the frequency and profile of ADRs generated by anti-infective treatment, declared at the Moroccan Anti-Poison and Pharmacovigilance Center (MAPPC).A retrospective descriptive study was implemented from the notifications of ADRs generated between 2008 and 2016 and recorded on VIGIBASE. Over the research period, 1161 cases of ADRs reports were declared. The average age was 37.4 years ± 19.52, it’s been noticed that the adults were the most affected in 81.89% of the total cases, with the sex ratio (Female / Male) being 1.34. Antimycobacterials and antibacterials for systemic use were responsible for 68% and 28.3% of the adverse reactions, respectively. 29.76% of the cases showcased skin and subcutaneous tissue disorders and 23.23% of the cases displayed hepatobiliary and pancreatic system disorders. Serious cases represented 30% of all noted cases, including 2 fatalities. In the interest of preventing the risk of adverse reactions originating from the taking anti-infective drugs for systemic use, reporting to the ADRs to the pharmacovigilance system should be highly encouraged.

Regulatory Safety Learning Driven by the Mechanism of Action: The Case of TNF‐α Inhibitors

The summary of product characteristics (SmPCs) is an important information source that includes the adverse drug reactions (ADRs) associated with the drug. Drugs with the same mechanism of action are expected to have a similar ADR profile and thus a substantial overlap of the described ADRs in the SmPC. The objective of this study is to assess this overlap. We extracted all ADRs (excluding hypersensitivity and administration site reactions) that were described in the first and all subsequent versions of the SmPCs of all approved TNF‐α inhibitors in the European Union. The Medical Dictionary for Regulatory Activities was used to characterize the ADRs. At the end of follow‐up, 293 unique ADRs (at high level term level) were described in the SmPCs of the 5 TNF‐α inhibitors. There was substantial variation in the number of ADRs described in the SmPC among the TNF‐α inhibitors. Of the 293 ADRs, 133 (45%) were described in the SmPC of one TNF‐α inhibitor and 39 (13%) in the SmPCs of all 5 TNF‐α inhibitors. Serious ADRs and ADRs classified as important risks were described approximately four times more often in a second SmPC than ADRs not classified as such. In conclusion, the ADRs described in the SmPCs of the TNF‐α inhibitors differ considerably in number and type. In order to adequately inform prescribers and patients, acquired knowledge of the safety profile of drugs with the same mechanism of action should increasingly be taken into account in the assessment of all drugs within the class.

Adverse drug reactions in elderly: a five-year review of spontaneous reports to the Portuguese pharmacovigilance system

ABSTRACT Background: Adverse drug reactions (ADRs) are responsible for considerable morbidity and mortality in elderly. This study aimed to characterize the ADRs profile in Portuguese elderly patients, thus enhancing ADRs knowledge in this vulnerable population. Methods: All spontaneous ADRs reported to the Portuguese Pharmacovigilance System from 2013 to 2017 were examined. However, considering the aim of this study, ADRs referring to patients aged 65 and over were analyzed in higher detail and compared with those reported in non-elderly adults. Results: Considering the age of 65 years and above, 3692 spontaneous reports of suspected ADRs were analyzed. The suspected ADRs most frequently reported fall within the categories of general disorders and administration site conditions, and skin and subcutaneous tissue complaints. Regarding therapeutic agents, the antineoplastic drugs were the most common involved. Among the 2458 cases of serious ADRs reported, 34.0% led to hospitalization and in 5.8% of them occurred a fatal outcome. The antineoplastic and antithrombotic drugs were the most represented pharmacotherapeutic groups of suspected drugs involved in patient’s death (25.0% and 13.6%, respectively). Conclusions: Most of the suspected ADRs were classified as serious. The majority of them were expected, so preventable, highlighting the importance of improving medication use in elderly.

Profils d’effets indésirables sous abiratérone et enzalutamide : analyse descriptive des données de la base nationale de pharmacovigilance

The aim of this study was to describe the profile of adverse drug reactions (ADRs) observed with abiraterone and enzalutamide, based on cases registered in the French regional pharmacovigilance centres to identify potential pharmacovigilance signals. We extracted from the French pharmacovigilance database all cases of ADRs or drug interactions involving abiraterone or enzalutamide from the time they market authorization date until December 31st, 2017. Signal detection results have been transmitted by the French Agency for Health Products (ANSM). The data were compared with those of the risk management plans for each drug and the literature. Among the 233 observations analyzed, nearly 62% involved abiraterone as a suspect drug and 38% involved enzalutamide; only 1 case involved both drugs. The ADRs profile is different between the drugs. Abiraterone is mostly associated with expected cardiac diseases (heart failure, and QT prolongation), expected with the drug. Also described, several cases of hepatotoxicity have been reported, however some cases with fatal outcome suggest that despite a follow-up of the liver function tests, it is difficult to anticipate this risk. Signals concerning acute renal failure and ischemic stroke have arisen. Enzalutamide is more particularly associated with various neurological disorders (convulsions, hallucinations, fatigue, and memory impairment) expected with the drug. While ischemic heart disease is also expected, signals of heart failure and atrial fibrillation have arisen. A potential hepatotoxicity of the molecule is discussed because of cases of cholestatic hepatitis. The analysis of the French pharmacovigilance database cases allows to confirm an expected and monitored risk profile in the risk management plan for both drugs. Several signals have arisen, some of which will be investigated through a pharmacoepidemiology study.

Clinical Profile of Adverse Cutaenous Drug Reactions in Patients with Human Immunodeficiency Virus

Background: Adverse cutaneous drug reactions (ACDRs) are common problems in patients during the treatment of various diseases. The clinical feature varies from mild manifestation such as morbilliform, urticaria, and contact dermatitis, to severe manifestation such as Stevens - Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). Patients infected with the human immunodeficiency virus (HIV) have an increased risk of developing ACDRs due to immune system disruption. This study aimed to describe the clinical features of ACDRs in HIV patients and the drugs that cause ACDRs. Method: This study was a retrospective study using secondary data from medical records of HIV patients with ACDRs who visited Teratai Clinic of Dr. Hasan Sadikin General Hospital Bandung from 2014 to 2018. Total sampling was applied and results were presented in percentage. Results: There were 94 HIV patients with ACDRs out of 557 HIV patients. Adverse cutaneous drug reactions are commonly found in males aged 20-39 years old. The clinical features found were morbilliform (85.6%), SJS (8.9%), urticaria (4.4%), and erythroderma (1.1%). The most common drugs causing ACDRs were Cotrimoxazole (30%), Efavirenz (28.9%), and Nevirapine (16.7%). Conclusion: The prevalence of ACDRs in HIV patients in this study is 16.9%. The most common clinical features are morbilli form and SJS with Cotrimoxazole, Efavirenz, and Nevirapine causing most of the ACDRs.

Red yeast rice (Monascus purpureus) supplements: Case series assessment of spontaneously reported cases to The Netherlands Pharmacovigilance Centre Lareb.

Serious concerns are expressed on the safe use of red yeast rice (RYR) supplements. The aim of the present study was to analyse cases received by Lareb on RYR‐related adverse health events. These cases were analysed for the number of reports, number of adverse drug reactions (ADRs), causality, seriousness of the reaction, latency‐period, age and sex of the patients, concomitant medication and type of reporter. A total of 94 individual reports were collected by Lareb, corresponding with 187 ADRs. The analysis showed most reported ADRs were labelled musculoskeletal and connective tissue disorders (n = 64), gastrointestinal disorders (n = 33) and general disorders and administration site conditions (n = 23). The use of RYR supplements should be considered as a significant safety concern. Exposure to monacolin K could lead to serious adverse effects. To fully assess the safety profile of RYR supplements, more research is necessary to compose a complete ADR profile of RYR supplements.

SAFETY OF HYDROXYCHLOROQUINE FOR COVID-19 PROPHYLAXIS AMONG HEALTHCARE WORKERS: AN OBSERVATIONAL STUDY

Objective: Indian Council of Medical Research recommended hydroxychloroquine (HCQ) for prophylaxis of COVID‐19 for healthcare workers and the Food and Drug Administration approved its use in the treatment and prophylaxis of COVID‐19 disease. Even though HCQ is adequately tolerated in usual circumstances, still questions about the harmful effects of the drug remain a cause for concern in adults treated with HCQ. The objective of this study was to evaluate the major and minor adverse effects of prophylactic HCQ for COVID-19 among healthcare workers.
 Methods: Our analysis was intended to analyze HCQ’s adverse drug reaction profile for COVID‐19 prophylaxis in prophylactic doses in health-care staff. This was a cross-sectional study carried out among healthcare workers taking HCQ prophylaxis for COVID‑19. The study was carried out over 08 weeks period from April to May 2020. The data were obtained regarding age, sex, comorbidities, and possible adverse effects. A pretested and validated online questionnaire was provided to the participants to assess the harmful effects that they experienced when taking HCQ. Furthermore, pre and post 8 weeks prophylaxis, individuals underwent general and systemic examination, along with ECG and blood sugar level monitoring.
 Results: The research group comprised 70 previously healthy and health-care staff. In 70 patients, 27 minor adverse effects were reported (18.9%). Headache was the most frequently reported symptoms followed by nausea and vomiting, itching, and skin rashes. There was no statistically relevant variation in harmful effects due to age or number of doses administered. However, none of the adverse effects was serious or debilitating.
 Conclusion: With adequate pre-prophylaxis evaluation, health education, and regular monitoring, HCQ prophylaxis is safe and devoid of any serious adverse effects in previously healthy individuals.