Experienced Adverse Drug Reactions Research Articles

Coadministration of Voriconazole and Rifabutin Can Increase the Risk of Adverse Drug Reactions in Patients with Multiple Infections.

Coinfection of tuberculosis or nontuberculous mycobacteria and Aspergillus presents a challenge in medication selection because of the pharmacokinetic interactions between rifampin and voriconazole. Some researchers have suggested the use of rifabutin as an alternative to rifampin because of its lower hepatic cytochrome P450 enzyme induction potency despite its contraindication to drug labels. This study presents clinical cases of voriconazole and rifabutin coadministration and their potential risks. This retrospective study was conducted using clinical data from patients who met the following criteria: (1) admitted to Seoul National University Hospital between July 2014 and August 2023 and (2) concurrently administered rifabutin and voriconazole for more than 5 days. Among the 6 patients analyzed, 4 experienced adverse drug reactions (ADRs). Three patients experienced visual and auditory hallucinations, lower extremity numbness, or delirious behavior. Two patients had prolonged the time from the start of the Q wave to the end of the T wave intervals, and 1 had elevated aspartate aminotransferase and alanine aminotransferase levels. In addition, 2 patients experienced severe nausea, poor oral intake, and weight loss. Despite receiving 1.81-fold the recommended voriconazole dosage, a therapeutic concentration (1.0-5.5 mg/L) was not achieved because of cytochrome P450 induction by rifabutin. However, during septic shock, the voriconazole concentration increased by 13.7- to 36-fold. Concurrent use of rifabutin and voriconazole was associated with ADRs, including the time from the start of the Q wave to the end of the T wave prolongation, hallucinations, and severe nausea. Moreover, initially, there was a significant decrease in voriconazole concentrations; however, these concentrations substantially increased during septic shock. Therefore, it is essential to monitor drug concentrations and ADRs during concurrent use of voriconazole and rifabutin.

Angiotensin-converting enzyme inhibitors, statins and the polypill in cardiovascular diseases prevention: ignorance is bliss or not?

The polypill strategy, which combines several medicines that simultaneously control different risk factors/diseases in a single pill, is one of the approaches used in cardiovascular therapy. In different guidelines, this one-pill combination therapy is suggested as first-line step in disease management. Because the cardiovascular diseases (CVD) pandemia, prevention is essential. The approaches that could improve adherence are of great importance to achieve health, social and economical benefits. However, direct or indirect experience of adverse drug reaction is often the reason for discontinuation, with serious fatal and non-fatal consequences especially for a polypill. Angiotensin-converting enzyme inhibitors (ACEi) and statins are the most prescribed medications in CVD prevention. It is well known that both drugs may have adverse effects that induce discontinuation. Often, the personal awareness of these effects is a reason for self-discontinuation. In this study an analysis of the ACEi/statin awareness is reported. Is it potentially harmful for polypill?

Spotlight on eltrombopag concentration in pediatric immune thrombocytopenia: A single-center observational study in China.

Eltrombopag has been recommended for pediatric immune thrombocytopenia (ITP). Response and adverse drug reactions (ADRs) varied widely between individuals, even at the same dose of eltrombopag. The appropriate eltrombopag concentration in ITP has not been reported. This study aims to explore the appropriate eltrombopag concentration in pediatric ITP. This was a single-center, prospective cohort study. Children diagnosed with refractory persistent/chronic ITP and platelet count < 30×109/L were treated with eltrombopag and followed up for at least 2 months. Concentration was detected by high-performance liquid chromatography-mass spectrometry at least 2 weeks after eltrombopag. The clinical characteristics-concentration, concentration-response, and concentration-ADRs were analyzed. A total of 30 patients were enrolled, comprising 13 males and 17 females, with a median age of 72 (45‒94) months. The median dose and concentration were 1.39 (1.09‒1.56) mg/kg and 2.70 (2.25‒4.13) mg/L, respectively. Of the enrolled patients, 14 responded to treatment, whereas 16 did not. Additionally, five experienced adverse drug reactions. No linear correlation was observed between eltrombopag concentration and clinical characteristics. The concentration was lower in the response group than in the nonresponse group, but there was no significant difference (t = 0.755, P = 0.457). Patients who experienced ADRs had a higher concentration than those without ADRs (t = 2.538, P = 0.017). The area under the receiver operating characteristic curve of ADRs was 0.78 (95% confidence interval: 0.56‒1.00). Youden's index identified the cutoff point as 4.33 mg/L, with a sensitivity of 88% and a specificity of 60%. Logistic regression analysis demonstrated that a higher platelet count before eltrombopag predicted a favorable response. Eltrombopag proves efficacious and well-tolerated for treating pediatric ITP. However, prolonged and high-dose administration may increase the likelihood of ADRs. Thus, examining the appropriate eltrombopag concentration assists in directing individualized management of pediatric ITP.

A risk identification model for detection of patients at risk of antidepressant discontinuation.

Between 30 and 68% of patients prematurely discontinue their antidepressant treatment, posing significant risks to patient safety and healthcare outcomes. Online healthcare forums have the potential to offer a rich and unique source of data, revealing dimensions of antidepressant discontinuation that may not be captured by conventional data sources. We analyzed 891 patient narratives from the online healthcare forum, "askapatient.com," utilizing content analysis to create PsyRisk-a corpus highlighting the risk factors associated with antidepressant discontinuation. Leveraging PsyRisk, alongside PsyTAR [a publicly available corpus of adverse drug reactions (ADRs) related to antidepressants], we developed a machine learning-driven algorithm for proactive identification of patients at risk of abrupt antidepressant discontinuation. From the analyzed 891 patients, 232 reported antidepressant discontinuation. Among these patients, 92% experienced ADRs, and 72% found these reactions distressful, negatively affecting their daily activities. Approximately 26% of patients perceived the antidepressants as ineffective. Most reported ADRs were physiological (61%, 411/673), followed by cognitive (30%, 197/673), and psychological (28%, 188/673) ADRs. In our study, we employed a nested cross-validation strategy with an outer 5-fold cross-validation for model selection, and an inner 5-fold cross-validation for hyperparameter tuning. The performance of our risk identification algorithm, as assessed through this robust validation technique, yielded an AUC-ROC of 90.77 and an F1-score of 83.33. The most significant contributors to abrupt discontinuation were high perceived distress from ADRs and perceived ineffectiveness of the antidepressants. The risk factors identified and the risk identification algorithm developed in this study have substantial potential for clinical application. They could assist healthcare professionals in identifying and managing patients with depression who are at risk of prematurely discontinuing their antidepressant treatment.

Sex differences in adverse drug reactions from Adalimumab and etanercept in patients with inflammatory rheumatic diseases

ABSTRACT Background We examine sex differences in relation to the nature, frequency, and burden of patient-reported adverse drug reactions (ADRs) in patients with inflammatory rheumatic diseases. Research design and methods Rheumatoid arthritis, psoriatic arthritis, or axial spondyloarthritis patients using etanercept or adalimumab from the Dutch Biologic Monitor were sent bimonthly questionnaires concerning experienced ADRs. Sex differences in the proportion and nature of reported ADRs were assessed. Additionally, 5-point Likert-type scales reported for the burden of ADRs, were compared between sexes. Results In total 748 consecutive patients were included (59% female). From the women 55% reported ≥1 ADR, which was significantly higher than 38% of the men that reported ≥1 ADR (p < 0.001). A total of 882 ADRs were reported comprising 264 distinct ADRs. The nature of the reported ADRs differed significantly between both sexes (p = 0.02). Women in particular reported more injection site reactions than men. The burden of ADRs was similar between sexes. Conclusions Sex differences in the frequency and nature of ADRs, but not in ADR burden, exist during treatment with adalimumab and etanercept in patients with inflammatory rheumatic diseases. This should be taken into consideration when investigating and reporting results on ADRs and when counseling patients in daily clinical practice.

Adverse drug reactions in children and adolescents on daily antitubercular regimen: An observational longitudinal study

ObjectivesSubsequent to introduction of daily fixed dose combination (FDC) regimen with increased dosages and inclusion of ethambutol in continuation phase of antitubercular therapy (ATT) in India, this study was done to evaluate adverse drug reactions (ADRs) in children and adolescents. MethodsLongitudinal observational study conducted in tertiary teaching hospital. Children (1 month–18 year), with newly diagnosed drug sensitive tuberculosis, started on daily FDC regimen of ATT, were included. Participants were followed up at 2 weeks, 8 weeks and 6 months. Division of AIDS (DAIDS) severity grading and World Health Organization-Uppsala Monitoring Centre (WHO-UMC) causality assessment was done. ResultsIn 99 participants, 29 experienced ADRs. Most commonly ADRs involved hepatobiliary (11.1%) and gastrointestinal (8.1%) systems. Grade 3 severity noted in 35.5% ADRs. Certain causality classified in 19.3%. Presence of ADRs was significantly higher in participants with vs without malnutrition [40.5% vs 21.1% (p = 0.036)]. Tendency for more severe ADRs noted in participants with vs without malnutrition [Grade 3 ADRs out of all ADRs: 64.7% vs 0% (p < 0.001)]. ConclusionIncidence and severity of ADRs has increased after introduction of daily FDC of ATT. Most common ADR observed were hepatobiliary. Malnutrition and less weight for age were risk factors for occurrence and severity of ADRs.

Safety, acceptability, and adherence to a dolutegravir-based regimen among adults living with HIV at Kenyatta National Hospital

Background: Dolutegravir-based therapy was rolled-out in Kenya in 2017 with limited safety studies in the country and Africa. This study sought to assess and profile the adverse drug reactions, acceptability, and adherence to the newly rolled out dolutegravir-based regimens among HIV patients attending Kenyatta National Hospital.Methods: This was a cross-sectional study conducted between November and December 2019 at Kenyatta national hospital comprehensive care clinic. Through systematic random sampling, a sample of 219 adult HIV patients on a dolutegravir-based antiretroviral regimen were recruited and interviewed for the experience of adverse drug reactions, adherence, and acceptance of the dolutegravir-based regimen using a researcher-administered questionnaire. Descriptive analysis was conducted using IBM SPSS V 21 software. The alpha was set at p≤0.005.Results: A-quarter of the patients (24.7%, n=54) reported experiencing drug-related adverse drug reactions. The most frequent adverse reaction was insomnia (24.1%, n=19), followed by headaches (19.0%, n=15) and skin reactions (13.9%, n=11). The least cited was vomiting (2.5%. n=2). Most (87.3%, n=69) of the adverse reactions were mild (grade 1 reactions), with very few (7.6%, n=6) of them being severe (toxicity grade 3). Only 2 (0.9%) of the reactions resulted in the dolutegravir-based regimen switch. Adherence was high (97.3%, n=213), and 90.4% (n=198) of patients reported to accept the new dolutegravir-based regimen.Conclusions: Adult patients living with HIV on a dolutegravir-based regimen experienced some adverse drug reactions; mostly mild and resolved without medical intervention. Generally, the regimen had an acceptable safety profile, and a high adherence rate was reported.

159 DOES SHARED DECISION MAKING (SDM) ADDRESS POTENTIALLY INAPPROPRIATE PRESCRIBING (PIP)?

Abstract Background Potentially Inappropriate Prescribing (PIP) as identified by STOPP/START criteria is associated with poor patient outcomes. The objective of this study was to investigate the extent of reduction in PIP achieved by Shared Decision Making (SDM) employed by pharmacists delivering, comprehensive, person-centred medication reviews as part of the EU INTERREG-VA funded iSIMPATHY project. The relationship between reductions in PIP and improvements in the iSIMPATHY Patient Reported Outcome Measures (PROMs) was explored. Methods This study was conducted across 3 General Practice (GP) practice sites. List of eligible patients aged ≥65 years and on ≥10 regular medications were generated from practice software. Patients were contacted by phone and offered iSIMPATHY reviews and consented to data collection. The first 100 iSIMPATHY reviews actioned by the GPs and for which post review PROM data was collected were included. Data was independently reviewed and analysed by the Medication Safety, Quality Improvement Division of the Health Service Executive. Results At least one STOPP/START criteria was identified in 93% of study participants and an average of 4 per patient, were found. 76% of these were resolved within the study timeframe. 88% of patients reported an improvement in at least one PROM domain. 76% reported an improvement in their Understanding, 54% in their experience of Adverse Drug Reactions (ADRs), 21% in their Activities of Daily Living (ADLs) and 8% in adherence. 68% of STOPP/START criteria were resolved for the 53% patients reporting improvements in 0-1 PROM domains, whereas 85% were resolved for the 47% reporting improvements in 2-4 domains. Conclusion Delivery of the iSIMPATHY medication review service in the Irish GP practice setting significantly improves both medicines appropriateness and Patient Reported Outcome Measures (PROMs). There appears to be a positive relationship between the extent in reduction in PIP achieved by SDM and reported improvements in PROMs. The relationship between PROM outcomes and individual PIP criteria warrants further investigation.

Pharmacists’ involvement with and pharmacy clients’ awareness of adverse drug reaction reporting in Nigeria – a mixed-methods approach

Abstract Objectives Adverse drug reactions are one of the leading causes of death, yet they are under-reported. This study assessed the involvement of community pharmacists in the identification, documentation, and reporting of adverse drug reactions and pharmacy clients’ awareness of the adverse drug reaction reporting system. Methods A cross-sectional questionnaire-guided survey was conducted among 780 pharmacy clients in six selected community pharmacies, and seven mystery clients visited 125 community pharmacies in Ibadan, Nigeria. Information on pharmacy clients’ experience of adverse drug reactions, to whom and how they were reported, was obtained. Female and male mystery clients’ performed two scripted scenarios, complaining of black patches on their thighs and blood in their faeces, respectively. The proportion of pharmacists who identified the complaints as adverse drug reactions, documented and reported them, was described. Key findings The response rate for the pharmacy clients’ survey was 98.5%. Some pharmacy clients, 385 (50.1%), had experienced adverse drug reactions; 49 (12.7%) of these pharmacy clients were hospitalised and 73 (19.0%) of them reported the adverse drug reactions to physicians or pharmacists. Most of the pharmacy clients, 706 (91.9%), did not use the available reporting system. A total of 218 mystery client visits were made. The proportion of pharmacists who recognised the mystery client complaints as adverse drug reactions was 4.9–60.3% depending on the scenario presented and up to two pharmacists documented and supposedly reported the adverse drug reactions. Conclusions Some of the pharmacy clients reported experiencing adverse drug reactions to healthcare professionals, but most did not report through the existing reporting scheme. Community pharmacists could identify adverse drug reactions but most failed to document or report them.

Safety and efficacy of anagrelide in Japanese post-marketing surveillance, with subgroup analyses on the effect of previous cytoreductive therapies, age, and starting dose

BackgroundIn Japan, anagrelide has been approved for use in patients with essential thrombocythemia. Here, the safety and efficacy of anagrelide was assessed in clinical practice as post-marketing surveillance. Subgroup analyses were conducted to compare patients (1) with or without a history of cytoreductive therapy (CRT), (2) <60 or ≥60 years of age, and (3) with an anagrelide starting dose of ≤0.5 mg/day or 1.0 mg/day.MethodsData were collected for all patients who received anagrelide, with an observation period of 12 months after treatment initiation.ResultsOf the 648 patients, 54.3% experienced adverse drug reactions (ADRs). The most commonly reported ADRs were headaches, palpitations, and anemia. No significant difference was observed in overall ADRs across patient subgroups. A significantly higher incidence of headaches was observed in patients < 60 years versus those ≥ 60 years (P < 0.001). The incidence of anemia and serious ADRs were significantly higher in patients ≥ 60 years, and those with a history of CRT (P < 0.05). The discontinuation rate at 6 months was significantly lower in patients started at the lower anagrelide dose (P < 0.05). Platelet counts decreased in all analyzed groups.ConclusionsThis surveillance showed that anagrelide has a tolerable safety and efficacy profile.

A pharmacovigilance study on antiepileptic medications in a paediatric hospital in Italy

ObjectiveThe standard treatment for epilepsy is based on the appropriate use of antiseizure medications (ASMs) to prevent the recurrence of seizures. For the newer ASMs, however, little information on their...

Drug utilization pattern and adverse drug reactions of chemotherapy in pediatric patients at Muhimbili National Hospital, Tanzania.

Background: Cancer is a highly debilitating non-communicable disease and an essential contributor to the global burden of disease. Pediatric patients are highly exposed to multiple drugs for the management of cancer. Monitoring drug utilization patterns helps to provide feedback to healthcare providers to ensure the rational use of medicines; as a result, it increases the therapeutic efficacy and decreases the frequency and severity of adverse drug reactions (ADRs). Therefore, this study assessed the utilization pattern and ADRs of chemotherapy in pediatric patients at Muhimbili National Hospital (MNH). Methods: A descriptive cross-sectional study was conducted for three months from February to April 2021 in pediatric cancer patients undergoing chemotherapy at MNH. A total of 123 children diagnosed with cancer and on chemotherapy were enrolled in this study. Patients' socio-demographics, clinical information, chemotherapy status, prescribed medications, and prevalence of ADRs were collected. Descriptive statistics was used in data analysis, whereby frequency and proportions were used to summarize data. Results: Out of 123 patients, 62.6% were male. Most patients received an average of four anticancer drugs. Vincristine (55.3%) was the most used anticancer drug, followed by cytarabine (44.7%) and methotrexate (42.3%). The most used adjuvant drugs were ondansetron (30.9%), hydrocortisone (27.6%), and piperacillin/tazobactam (23.6%). The percentage of drugs prescribed from the Tanzania Essential Medicine List (TEML) and World Health Organization (WHO) list was 66.4% and 93%. Most (87%) of the patients reported having experienced ADRs whereby nausea and vomiting (45.8%), hair loss (33.6%), and neutropenia (32.7%) were more prevalent ADRs reported. Conclusions: This study found the drug prescribing pattern to be in line with the essential medicine list, but the average number of drugs prescribed was higher than recommended. ADRs were prevalent among pediatric cancer patients.

Identifying and managing adverse drug reactions: Qualitative analysis of patient reports to the UK yellow card scheme.

IntroductionAdverse drug reactions (ADRs) can have significant negative impact on peoples' daily lives, with physical, economic, social and/or psychological effects. Patient reporting of ADRs has been facilitated by pharmacovigilance systems across Europe. However, capturing data on patients' experiences of ADRs has proved challenging. Existing patient reports to the UK Yellow Card Scheme contain free‐text comments which could be useful sources of information.ObjectivesTo investigate patients' experiences of ADRs and their impact on patients as described in free‐text data within patient Yellow Card (YC) reports submitted to the Medicines and Healthcare products Regulatory Agency.MethodsA qualitative review of narrative texts was conducted on free‐text data from 2255 patient YC reports from July to December 2015.ResultsThree key narrative themes emerged from analysis of the free‐text data in 2255 reports: (1) identification of ADRs, (2) severity and impact of ADRs, and (3) management of ADRs. Temporal associations were the most common method of identification followed by differential diagnoses and confirmation with information sources such as healthcare professionals (HCPs). A combination of explicit and implicit impacts were described: physical, psychological, economic and social effects often persisted and caused serious disruption to many patients' lives. A range of strategies were used to manage ADRs, including consultation with HCPs, stopping/reducing the medicine or taking medicines to alleviate symptoms.ConclusionFree‐text data from YC reports has been an underutilised resource to date, but this research has confirmed its potential value to pharmacovigilance and medication safety research.

Safety and Effectiveness of Letermovir in Allogenic Hematopoietic Stem Cell Transplantation Recipients: Interim Report of Post-marketing Surveillance in Japan.

ObjectiveSince May 2018, a 6-year post‑marketing surveillance (PMS) has been underway to evaluate the safety and effectiveness of letermovir for cytomegalovirus (CMV) prophylaxis in Japanese patients with allogenic hematopoietic stem-cell transplantation (allo-HSCT). The interim PMS data for 461 patients collected as of March 2021 are reported in this publication.MethodsThe case report forms (CRFs) were drafted in part by the Japanese Data Center for Hematopoietic Cell Transplantation (JDCHCT) using data elements in the Transplant Registry Unified Management Program (TRUMP) and sent to individual HSCT centers to decrease burden of reporting. These CRFs were completed by physicians in the respective HSCT centers and sent to MSD K.K., Tokyo, Japan.ResultsAllo-HSCT recipients prescribed with letermovir for CMV prophylaxis were included across 136 centers in Japan between May 2018 and March 2021. Safety and effectiveness were assessed for 460 and 373 patients, respectively. Of the patients in the safety analysis, 13.9 % experienced adverse drug reactions, the most frequent of which were renal impairment (2.2 %) and nausea (1.7 %). Among patients in the effectiveness analysis, the overall CMV antigen positivity rate was 21.2 % at Week 14 and 37.5 % at Week 24 after allo-HSCT.ConclusionsInterim data from this largest of real-world studies confirm the safety and effectiveness of letermovir for CMV prophylaxis in Japanese allo-HSCT recipients. Given the limited data on Asian patients for letermovir use, this survey will provide valuable information for medical decision-making in routine clinical practice, serving as a vital supplement to the results obtained from clinical trials.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40261-021-01096-5.

Symptom experience of adverse drug reaction among male and female patients with newly diagnosed pulmonary tuberculosis in Thailand.

Patients with newly diagnosed pulmonary tuberculosis often suffer from adverse drug reaction symptoms, which leads to the automatic discontinuation of anti-tuberculosis drugs. Thus, understanding symptom experience of adverse drug reactions is necessary. This study aimed to examine differences in symptoms experienced in four dimensions: presence, frequency, severity, and distress of adverse drug reactions, between male and female patients. This was a quantitative survey with a cross-sectional design, with data collected between January and April 2020. A total of 394 patients with newly diagnosed pulmonary tuberculosis was selected through a purposive sampling technique. The symptom experiences of adverse drug reactions were measured using a validated instrument. Data were analyzed using mean, standard deviation, and independent t-test. The most commonly reported symptom was itchiness (24.1% in males and 34.9% in females). Vomiting occurred as the most frequent symptom among males (x̄ ± SD = 2.73 ± .88), and fatigue was found to be the most severe and distressing symptom across male patients (x̄ ± SD = 2.50 ± 1.61 and 2.06 ± 1.30, respectively). In contrast, yellowing of the eyes and skin was most frequent and severe among females (x̄ ± SD = 3.17 ± .75 and 3.83 ± 1.47, respectively). In addition, flu-like symptoms were evaluated as the most distressing symptom for female patients (x̄ ± SD = 2.80 ± 1.09). The symptom burdens of the females ranged significantly and reached higher than those of the male patients at a p-value of .05 (t = 3.33). Females taking anti-tuberculosis drugs should be carefully monitored to deal with adverse drug reaction symptoms. This finding would help to decrease the severity of disease and improve their quality of life.

Active Extraction of Experience of Adverse Drug Reactions in Children.

Safety information regarding the use of medication, over-the-counter drugs, and supplements for Japanese children is scarce. The aim of this study was to clarify adverse drug reaction (ADR) experiences in children and consider the method to collect ADRs efficiently. We conducted a questionnaire survey regarding the ADR experiences of 20,412 children who were attending a preschool or kindergarten in the cities of Warabi and Toda, Saitama Prefecture, in May 2013. Responses were received from the guardians of 15,076 children (49.5% girls; 8.2 ± 3.5 yr). A total of 196 guardians (1.3%) responded that their children had experienced ADRs. Among them, a total of 243 suspected drugs and 284 ADRs were reported. Of the 243 suspected drugs, 2.5% were associated with a vaccine. The most frequently reported medication, reaction, and "medication-reaction pair" were antibacterials for systemic use, rash, and "antibacterials for systemic use and rash," respectively. In this study, we clarified that there were many potential ADRs among children, but all "medication-reaction pairs" reported were consistent with adverse events reported in the clinical trials available in the prescribing information of each medication. This study provides data respective to the frequency of these adverse events in the general pediatric population. Additional education is needed to enlighten guardians of the importance to report ADRs through the Direct Patient Reporting System.

Prescription practices, experiences, and perspectives on the usage of hydroxychloroquine among rheumatologists and other specialists

Background/Objectives: The use of hydroxychloroquine (HCQ) for COVID-19 has raised concerns for adverse effects. We aimed to understand the practice, perceptions, and experience of adverse drug reactions (ADRs) with HCQ use for COVID-19 and other indications. Methods: A validated e-survey with 30 questions was circulated among rheumatologists and other specialists using SurveyMonkey. Responses from rheumatologists were compared with other doctors (odds ratio [OR], median, interquartile range), and ADRs encountered based on their indications. Results: Among 410 respondents (71.2% rheumatologists, 27% academicians) with a lifetime experience of 17886 (4884–52074) patients over 12 (7–20) years, and 148 (48–349) prescription of HCQ per month, one-third (135) were managing COVID-19 with 10 (0–60) prescriptions per physician. Electrocardiograms were seldom ordered preprescription (5%), but visual scans were requested by one-thirds, especially by rheumatologists (OR-1.9). Agreement on the safety of HCQ for non-COVID indications was nearly unanimous (99%), but only two-third (64%) perceived it to be safe for COVID-19, with most (72%) being uncomfortable using HCQ with macrolides. ADRs were most often encountered after middle-age with skin pigmentation (554 [123–2063]) being the most frequent, followed by gastrointestinal intolerance (222 [42–980] per million prescriptions). Cardiac toxicity was rarely reported. ADRs other than cutaneous and visual were noted more frequently by nonrheumatologists. Rheumatologists were less likely to consider HCQ unsafe (OR-0.04) and reportedly faced a greater challenge in drug procurance (OR-2.6) during the pandemic. Conclusions: Most ADRs are rare with HCQ use in our respondent population with a large user experience. HCQ use was considered unsafe by one-thirds in the setting of COVID-19 but not outside it, lesser so by rheumatologists.

Pharmacovigilance and radiologists: How well do they get along?

Considering the growing use of imaging modalities and contrast agents, radiologists are prone to encounter adverse drug reactions (ADR). In the current study, we mainly aim to evaluate the knowledge of radiologists regarding pharmacovigilance (PV). Also, we intend to gather information about their previous ADR experiences. Secondarily, we hope to increase the awareness about contrast-medium-related ADRs and attract attention to the importance of properly reporting these ADRs. A survey was generated by using an online survey webpage, and the relevant link was e-mailed to radiologists and radiology residents. The survey begins with a short explanation about the study. The second section contains questions about PV knowledge level, and the final section aims to gather information about the experienced ADRs. The survey was completed by 202 participants. 65.3% stated that they were aware of PV. 24.8% of the participants said that they know the national PV program. 97% told that they knew the term ADR. 66.3% of the participants encountered an ADR. 53.7% of them reported these ADRs. 70.8% of them reported these ADRs to a clinician. Radiologists encounter ADRs almost as frequently as the other doctors. Their awareness about PV is similar with other healthcare professionals. They have fewer information about TUFAM and PvCPs. Radiologists generally prefer to communicate with a clinician about an ADR. Overall condition of radiologists about PV is quite similar with other healthcare professionals and education can improve it, as for the others. Radiologists encounters ADRs almost as frequently as the other doctors. Overall condition of radiologists about PV is quite similar with other healthcare professionals and education can improve it, as for the others.

Patient-Reported Burden of Adverse Drug Reactions Attributed to Biologics Used for Immune-Mediated Inflammatory Diseases.

Although the burden of adverse drug reactions (ADRs) has a significant impact on patients' quality of life, thorough knowledge about patients' perspectives on the burden of ADRs attributed to biologics is lacking. This study was conducted to gain insight into the patient burden of ADRs experienced with biologic use. The Dutch Biologic Monitor is a prospective, multicentre, event monitoring cohort system including information collected by web-based questionnaires from patients using biologics, mainly for immune-mediated inflammatory diseases (IMIDs). Patients were asked to complete bimonthly questionnaires on biologics used, indication for the biologic, experienced ADRs, consequences of ADRs and burden on a five-point Likert-type scale, ranging from 1 (no burden) to 5 (very high burden). We assessed potential factors associated with patient-reported burden of ADRs. A total of 1355 patients completed 6293 questionnaires between 1 January 2017 and 1 May 2019. Almost half of the patients (665 patients, 49%), 69% with rheumatic diseases and 31% with other diseases, collectively reported 1720 unique ADRs. Infections and musculoskeletal complaints were the most burdensome ADRs and injection-site reactions were the least burdensome. ADRs leading to healthcare professional contact were more burdensome than ADRs without healthcare professional contact. Smoking, respiratory and psychiatric comorbidities were associated with higher burden of ADRs. Crohn's disease, use of adalimumab and use of sulfasalazine as combination therapy were associated with lower burden of ADRs. The patient perspective gives important insights into the burden of ADRs experienced with biologics. This information could be used by healthcare professionals to optimise treatment with biologics.

ADHERENCE AND ASSOCIATED ADVERSE DRUG REACTION WITH ANTIDEPRESSANTS MEDICATION AMONG DEPRESSION PATIENTS IN PSYCHIATRIC HOSPITAL IN POKHARA, NEPAL

Background: The present study determined the prescription pattern of antidepressants, adverse drug reactions (ADRs), the level of adherence, and factors affecting it.&#x0D; Methods: This prospective cross-sectional study was conducted with depression patients (n=174; 55.74% female) from August 2019 to November 2019 at a psychiatric hospital of Pokhara, Kaski, Nepal. The Naranjo ADR Probability Scale was employed to assess the ADRs. The rate of medication adherence (MA) was determined using Morisky MA Measurement Scale-Eight. Descriptive statistics (median, interquartile range, frequency, and percentage), bivariate analysis, and Chi-square test were used; p&lt;0.05 was taken as significant in multivariate analysis.&#x0D; Results: Selective serotonin reuptake inhibitors (SSRIs) were found to be the most commonly prescribed antidepressants (58.04%) followed by serotonin and noradrenaline reuptake inhibitors (SNRIs; 13.79%). More than half of the patients had a low level of adherence (52.29%) and about 74.13% experienced ADR. The most common ADRs were insomnia (17.05%) and anxiety (17.05%). Female were found to be more non-adherent compared to male (odds ratio 1.011; 95% confidence interval; 0.507–1.832). The level of adherence was found to be associated with the probability and severity of ADR.&#x0D; Conclusion: The majority of patients used SSRIs. ADRs were more prevalent. However, adherence to medications was extremely poor in the hospital, which was attributed to factors such as gender, occupation, education, and ADRs.