Management Of Adverse Drug Reactions Research Articles

Challenges and opportunities in dentistry regarding adverse drug reactions

Adverse drug reactions (ADRs) are a critical issue in dental practice, significantly impacting patient safety, treatment outcomes, and healthcare costs. This empirical study aims to explore the prevalence, causes, and management of ADRs among dental practitioners in Lucknow, Uttar Pradesh, India. Data were collected through a structured questionnaire distributed to 130 dental practitioners, focusing on the frequency of ADRs, types of drugs involved, management strategies, and barriers to reporting. The results revealed that 84.6% of practitioners encountered ADRs in the past year, with antibiotics (53.8%) and NSAIDs (30.8%) being the most commonly implicated drugs. Allergic reactions were the most frequently reported ADRs (46.2%), followed by gastrointestinal issues (23.1%) and systemic toxicity (15.4%). The primary management strategy was discontinuation of the offending drug (53.8%). Significant barriers to ADR reporting included lack of time (46.2%) and insufficient knowledge (30.8%). Inferential statistics showed no significant association between the type of practice and frequency of ADRs, but a significant association between years of practice and reporting practices, indicating more experienced practitioners are more likely to report ADRs. The study highlights the need for enhanced education and training, interdisciplinary collaboration, and the use of technology to improve ADR management and reporting in dental practice, ultimately aiming to enhance patient safety and treatment outcomes.

A PROSPECTIVE OBSERVATIONAL STUDY OF MONITORING AND REPORTING OF ANTIMICROBIAL DRUGS ASSOCIATED ADVERSE DRUG REACTIONS AND THEIR SIGNIFICANCE ON PATIENTS SAFETY AND HEALTH-CARE OUTCOMES

Objective: Adverse drug reaction (ADR) surveillance and reporting practices are at an early stage of development within the Indian context. The pharmacovigilance rate in India falls below 1%, which is notably lower compared to the global average of 5%. India holds the position of being the fourth most significant contributor to the pharmaceutical industry worldwide. Therefore, there exists a pressing demand to enhance the pharmacovigilance framework for safeguarding the health of the Indian population. ADR is defined as the unintended, obnoxious, and unwanted reaction due to the use of a drug. The administration of antimicrobial agents causes various ADR that has been analyzed throughout the study. The main objective of the research is to monitor and report the adverse drug reaction caused by antimicrobial drugs Methods: A prospective observational study was carried out in the various departments of the hospital with duration of 3 months including 100 patients using patient profile form and ADR reporting forms and analyzing with the scales for causality, severity, and preventability assessment. Results: During the study, 29 ADRs were found among 100 patients, with an incidence rate of 9.6%, more common in females (52%) than in males (48%). ADRs were most frequently reported in the age group of 35–51 years (34%), then 18–34 years (28%), and 1–17 years (24%). The general medicine department reported the highest number of ADRs (66%), followed by the pediatric department (24%). Cephalosporins caused the most ADRs (35%). Common ADRs included constipation, diarrhea (34%) and rashes, nausea, and vomiting (34%). Naranjo scale indicated that the causality of ADRs was probable (52%). Hartwig severity scale showed 55% ADRS to be mild. Schumock and Thornton method found that 76% of ADRs were preventable.Management of most of ADRs included drug withdrawal (52%). Conclusion: The majority of cephalosporin-related side effects, which included constipation, diarrhoea, and rashes, were observed. Most of the patients got better with the help of ADR monitoring and management. Finding and treating drug-related problems early make patients feel better and keep them safe. This study shows health-care system why it is important to monitor and report ADR caused by drugs.

Enhancing Outcomes in Chronic Fibrotic Interstitial Lung Disease Through Aggressive Management of Nintedanib-Induced Adverse Drug Reactions: A Retrospective Analysis.

Nintedanib, a tyrosine kinase inhibitor, is integral in slowing pulmonary fibrosis progression in chronic fibrotic interstitial lung disease (ILD). However, the occurrence of adverse drug reactions (ADRs) often limits its use, leading to treatment discontinuation, typically within 3-12 months. Discontinuation adversely affects patient outcomes. The study investigated whether aggressive ADR management can prolong nintedanib therapy and improve patient outcomes. This retrospective, single-center study enrolled Taiwanese patients with chronic fibrotic ILD who were treated with nintedanib from January 2016 to December 2022 in Kaohsiung Chang Gung Memorial Hospital. Patients were categorized into those who discontinued treatment within 180 days and those continuing beyond. Management of ADRs was identified through concurrent prescriptions for symptoms such as nausea, vomiting, diarrhea, or hepatic dysfunction. Baseline demographics, comorbidities, pulmonary function tests, and instances of acute exacerbation were analyzed. The study enrolled 94 patients, with 71 (75.5%) experiencing ADRs. Among these, 41 (43.6%) discontinued nintedanib within 180 days. The administration of medications for managing nausea/vomiting [17 (41.5%) versus 36 (67.9%), p = 0.0103] and diarrhea [12 (29.3%) versus 33 (62.3%), p = 0.0015] was less frequent in the discontinued group compared with the continued group. Additionally, a higher incidence of acute exacerbation was observed in the discontinued group (34.1% versus 20.8%, p = 0.016). Aggressive management of ADRs may enhance patient tolerance to nintedanib, potentially prolonging treatment duration and improving outcomes in chronic fibrotic ILD.

Patients' Identification, Management and Prevention of Adverse Drug Reactions: A Cross-Sectional Survey of Patients with Severe Adverse Drug Reactions.

Background: Few studies have been conducted on how patients identify, manage, and prevent severe adverse drug reactions (ADRs). This study aimed to explore the reasoning that patients use to identify symptoms of severe ADRs and the methods they employ to manage and prevent them. Methods: A cross-sectional survey using structured telephone interviews was administered to patients with a self-assessed severe ADR and to patients with serious skin ADRs from a hospital medical record database (in-patient and out-patient) from 1 September 2016 to 1 September 2019. Patients identified via the medical records were asked to assess their ADR for severity, and only patients that rated their ADR as severe were followed up with a telephone interview. Structured telephone interviews were conducted with respondents by a research pharmacist and audio-recorded. Results: A total of 722 patients with a severe ADR were identified, with 300 completing the interview (41.6%). The most frequently cited reasons for classifying ADRs as severe was worsening ADR symptoms (58.3%), severe ADR symptoms (44.4%), and ADR symptoms interfering with their life (36.4%). Only severe ADR symptoms were significantly different between the questionnaire and the medical records database groups (p = 0.007). The most frequent method of ADR management was discontinuation of drug by physicians (88.3%). About 79.0% of patients stated that they increased their carefulness when using other drugs after experiencing ADRs. The main method patients used to prevent ADRs was informing healthcare professionals (HCPs) about their drug allergy history (65.7%). Conclusions: Worsening ADR symptoms were often used to identify severe ADRs. However, HCPs were mainly responsible for the management and prevention of severe ADRs. Increasing awareness of ADRs by HCPs, and providing additional drug information, may improve patient safety.

Pharmacovigilance Practices by Healthcare Providers in Oncology: A Cross-Sectional Study.

Investigating pharmacovigilance (PV) practices among oncology healthcare providers (HCPs) is crucial for patient safety in oncology settings. This study aimed to assess the awareness, attitudes, and practices towards PV and identify barriers to effective adverse drug reaction (ADR) reporting for HCPs working in oncology-related settings. Employing a cross-sectional survey design, we collected data from 65 HCPs, focusing on their experiences with ADR reporting, education on ADR management, and familiarity with PV protocols. The results showed that about half of the responders were pharmacists. Around 58.9% of the respondents reported ADRs internally, and 76.9% had received some form of ADR-related education. However, only 38.5% were aware of formal ADR review procedures. Methotrexate and paclitaxel emerged as the drugs most frequently associated with ADRs. The complexity of cancer treatments was among the common reasons for the low reporting of ADRs by the study participants. The findings highlight the need for enhanced PV education and standardized reporting mechanisms to improve oncology care. We conclude that reinforcing PV training and streamlining ADR-reporting processes are critical to optimizing patient outcomes and safety in oncology, advocating for targeted educational interventions and the development of unified PV guidelines.

A Mobile Applet for Assessing Medication Adherence and Managing Adverse Drug Reactions Among Patients With Cancer: Usability and Utility Study.

Medication adherence and the management of adverse drug reactions (ADRs) are crucial to the efficacy of antitumor drugs. A WeChat applet, also known as a "Mini Program," is similar to the app but has marked advantages. The development and use of a WeChat applet makes follow-up convenient for patients with cancer. This study aimed to assess the usability and utility of a newly developed WeChat applet, "DolphinCare," among patients with cancer in Shanghai. A qualitative methodology was used to obtain an in-depth understanding of the experiences of patients with cancer when using DolphinCare from the usability and utility aspects. The development phase consisted of 2 parts: alpha and beta testing. Alpha testing combined the theory of the Fogg Behavior Model and the usability model. Alpha testing also involved testing the design of DolphinCare using a conceptual framework, which included factors that could affect medication adherence and ADRs. Beta testing was conducted using in-depth interviews. In-depth interviews allowed us to assist the patients in using DolphinCare and understand whether they liked or disliked DolphinCare and found it useful. We included participants who had an eHealth Literacy Scale (eHEALS) score of ≥50%, and a total of 20 participants were interviewed consecutively. The key positive motivators described by interviewers were to be reminded to take their medications and to alleviate their ADRs. The majority of the patients were able to activate and use DolphinCare by themselves. Most patients indicated that their trigger to follow-up DolphinCare was the recommendation of their known and trusted health care professionals. All participants found that labels containing the generic names of their medication and the medication reminders were useful, including timed pop-up push notifications and text alerts. The applet presented the corresponding information collection forms of ADRs to the patient to fill out. The web-based consultation system enables patients to consult pharmacists or physicians in time when they have doubts about medications or have ADRs. The applet had usabilities and utilities that could improve medication adherence and the management of ADRs among patients with cancer. This study provides preliminary evidence regarding the usability and utility of this type of WeChat applet among patients with cancer, which is expected to be promoted for managing follow-up among other patients with other chronic disease.

A RETROSPECTIVE ANALYSIS OF REPORTED CUTANEOUS ADVERSE DRUG REACTIONS IN A TERTIARY CARE TEACHING HOSPITAL

Objectives: Analysis of adverse drug reactions (ADR) reports enriches and updates physician’s awareness about the pattern of cutaneous adverse reactions in the population studied and may play an important role to envision the frequency of appearance of reactions to specific drugs and morphological designs. This study intends to portray the clinical profile and causative agents of dermal ADRs in our population. Methods: All the ADR reporting forms received from February 2021 to February 2023 were scrutinized, and forms with cutaneous ADRs (CADRs) were analyzed. The data about the history of drug intake, names of the drug taken, time lag of appearance of reaction, and clinical examination details were collected from the reports. Demography, prevalence, reaction time morphological pattern, and causative agents of CADRs were evaluated. Results: Among the CADRs, acute urticaria 53.4 was the most common followed by acute exanthematous reaction 35.8% and lichenoid drug eruption 3.8%. Among the drugs causing CADRs, antibiotics top the list with 47% followed by ATT at 29.7% and iron sucrose 12.9%. Among the antimicrobials, fluoroquinolones 48% top the list followed by cephalosporins 21.6% and penicillins and vancomycin each 8.3%. Conclusion: Physician’s knowledge about pattern and causative agents of CADR in the specific population can aid in prevention and early management of ADRs and thereby reducing hospitalization.

Assessment of antitubercular treatment induced adverse drug reactions data at a tertiary care hospital

Background: Standard anti-tuberculosis (TB) treatment is highly effective, but managing adverse drug responses is a major challenge that can negatively affect treatment compliance and outcomes of an anti-tubercular treatment (ATT) regimen. Hence, monitoring of these adverse drug reactions (ADRs) is very essential wherein the drug-causing ADR can be detected and an appropriate therapeutic regimen can be given to the patient. Aims and Objectives: To assess the ATT-induced ADRs in Individual Case Safety Reports (ICSRs), to find the incidence and prevalence of ADRs due to ATT, and to analyze the causality assessment of the ADRs due to ATT. Materials and Methods: A retrospective observational study was carried out using spontaneous ICSRs data from the ADR monitoring centre at Madras Medical College, Chennai. A suspected adverse drug reaction reporting form (sADR reporting form) provided by the Pharmacovigilance Programme of India was used to collect the data of an ICSR. Results: A total of 93 ICSRs were assessed during the study period. The majority of the ADRs occurred in males (n = 55), and the maximum number of ADRs were found in the age group of 18–44 years (n = 46). The majority of the ICSRs were categorized as “serious” (n = 60), of which the maximum number of ADRs belonged to the “hospitalization/prolonged hospital stay” category (n = 45). Most of the suspected ATT drugs involved in implicating ADRs were found to be fixed-dose combination pills of Isoniazid, Rifampicin, Pyrazinamide, and Ethambutol (n = 71). Most of the ADRs were “skin and subcutaneous disorders” (n = 51) of the system organ class. The outcome of the ADRs was assessed and found that the majority of them were in the “recovering” (n = 54) category, and the majority of the ICSRs were found to be “probable” (n = 67). Conclusion: An effective implementation of a Pharmacovigilance system with early detection and management of ADRs is needed to overcome the nonadherence to TB therapy.

Adherence, adverse drug reactions, and discontinuation associated with adverse drug reactions of HIV post-exposure prophylaxis: a meta-analysis based on cohort studies

Objective: Evaluate the profiles of post-exposure prophylaxis (PEP) adherence, adverse drug reactions (ADRs), and discontinuation associated with ADRs to provide information for further PEP program improvement and increase adherence to PEP.Methods: The Web of Science, PubMed, Embase, and the Cochrane Library were searched for cohort studies reporting data related to PEP adherence or ADRs (PROSPERO, CRD42022385073). Pooled estimates of adherence, the incidence of ADRs and discontinuation associated with ADRs, and their 95% confidence intervals (CI) were calculated separately for the included literature using random effects models. For substantial heterogeneity, meta-regression and subgroup analyses were conducted to explore sources of heterogeneity.Results: Overall adherence was 58.4% (95% CI: 50.9%–65.8%), with subgroup analysis showing differences in adherence across samples, with the highest adherence among men who had sex with men (MSM) (72.4%, 95% CI: 63.4%–81.3%) and the lowest adherence among survivors of sexual assault (SAs) (41.7%, 95% CI: 28.0%–55.3%). The incidence of ADRs was 60.3% (95% CI: 50.3%-70.3%), and the prevalence of PEP discontinuation associated with ADRs was 32.7% (95% CI: 23.7%-41.7%), with subgroup analyses revealing disparities in the prevalence of discontinuation associated with ADRs among samples with different drug regimens. Time trend analysis showed a slight downward trend in the incidence of ADRs and PEP discontinuation associated with ADRs.Conclusion: Adherence to PEP was less than 60% across samples, however, there was significant heterogeneity depending on the samples. SAs had the lowest adherence and the highest incidence of PEP discontinuation. Ongoing adherence education for participants, timely monitoring, and management of ADRs may improve adherence.

Adverse drug reactions as cause of nonspecific symptoms in patients in the emergency department

In alarge proportion of patients admitted to the emergency department (ED), the initial main symptom is nonspecific. One possible reason for this, especially in older patients, may be adverse drug reactions (ADR) due to their frequent polypharmacy. To illustrate the incidence of ADRs, the affected patient population including risk factors, and drug classes with ADRs leading to nonspecific symptoms. To provide practice recommendations for the management of ADRs in the ED. Presentation of the pharmacological principles on ADRs, statistics of pharmacovigilance centers as well as original literature including experiences from clinical practice and own projects. In 10% of patients with nonspecific symptoms an ADR is responsible for presentation in the ED. In 60% of cases these ADRs are not correctly identified in the ED setting. Asmall number of drug classes are responsible for most of these referrals. Databases, risk stratification, clinical pharmacists, or clinical decision support systems are available to improve ADR identification and management. As these options are partly associated with considerable costs or the validation for German EDs is missing, awidespread application does not take place. Correct identification of ADRs in patients with nonspecific symptoms in the ED is necessary to initiate adequate treatment. These ADRs are often overlooked because processes and tools for identification and management are not applied in the ED, leading to a lack of awareness. For high-risk patients in the ED, the focus should be on drug history, ideally considering patient-specific risk factors and specific drug classes.

Impact of web application support versus standard management on adherence with adjuvant hormone therapy in patients treated for breast cancer: the WEBAPPAC study

BackgroundNon-metastatic breast cancer treatment is mainly based on surgery, with or without chemotherapy, radiotherapy and/or hormone therapy. To reduce the risk of hormone receptor positive (HR+) disease recurrence, hormone therapy is prescribed for at least 5 years. It may induce adverse drug reactions (ADRs) as joint pain, sexual dysfunction, weight increase, fatigue, mood disorders and vasomotor symptoms. Around 30–40% of patients withhold hormone therapy within 5 years after initiation. Based on encouraging results of mobile health in patient follow-up, we developed a web-application addressed for breast cancer patients initiating adjuvant hormonal therapy and aimed to assess its impact on hormone therapy adherence, ADRs management, and health-related quality of life.MethodsThe WEBAPPAC trial is a randomized, open-label, prospective, single-center phase 3 study aiming to assess the interest of a web-application support as compared to standard management among breast cancer patients initiating hormone therapy. The main endpoint is the proportion of patients with hormone therapy adherence failure within 18 months after treatment start, in each arm. Eligible patients will be 1:1 randomized between the WEBAPPAC web-application support (experimental arm,) or standard support (control arm), with stratification on type of hormone therapy (Aromatase inhibitor or Tamoxifen). We plan to enroll 438 patients overall. Failure to hormone therapy will be assessed using the Morisky 8-item self-questionnaire (MMSA8), patient adherence logbook, and medical consultations. Secondary outcomes include hormone therapy adherence at 6 months, pain (Visual Analogue Scale and Brief Pain Inventory), quality of life (EORTC QLQ-C30 and BR23 self-questionnaires), anxiety and depression (Hospital and Depression Scale), and return to work and/or daily activities. The user experience with the WEBAPPAC web-application will be assessed using the System Usability Scale (SUS) questionnaire.DiscussionHormone therapy discontinuation or adherence failure in breast cancer patients may be indirectly related to an increased risk of recurrence. A better control of medication adherence, through the detection of side effects and some proposed actions trying to reduce them, appears therefore essential to limit the risk of disease recurrence. The WEBAPPAC web-application thus aims better monitoring and allowing higher level of responsiveness in case of ADRs, thus improving treatment adherence.Trial registrationNCT04554927, registered September 18, 2020.Protocol versionVersion 2.1 dated from December 21, 2021.

Cost Estimations of Managing Adverse Drug Reactions in Hospitalized Patients: A Systematic Review of Study Methods and Their Influences

This study aimed to systematically review and explore the impact of study methods on the cost of managing adverse drug reactions (ADRs) among hospitalized patients to guide policymakers and researchers. A literature search was conducted in MEDLINE, EMBASE, CINAHL, Cochrane Library, and Google Scholar. The search was restricted to studies from 2000 to 2017. Two authors independently reviewed the studies, assessed their risk of bias, and extracted information for analysis. Data abstraction was based on the study design, ADR reporting, and costing approaches. Of 677 studies identified, 12 were included for analysis. All studies defined ADR according to WHO classifications. The percentage of admission due to ADR ranged from 0.03% to 17.11%. All studies adopted a healthcare provider perspective, using either a micro-costing (n = 7), case-mix group costing (n = 3), or average-per-diem costing (n = 2) approach. The cost per ADR widely fluctuated from USD 65.00 to USD 12,129.90 based on various factors. The micro-costing approach generally had a lower cost compared to other approaches. The cost per ADR in high-income countries was also 10 times higher than in lower- or middle-income countries. This study evidenced that the methodological heterogeneity across studies has resulted in a wide range of cost estimations for ADR management.

ASSESSMENT OF KNOWLEDGE, ATTITUDE AND BEHAVIOR ON ADVERSE DRUG REACTIONS BETWEEN COMMUNITY AND HOSPITAL PHARMACISTS: A QUESTIONNAIRE-BASED STUDY

Adverse drug reactions (ADRs) are a significant drug-related cause of disease and death. Pharmacovigilance (PV) plays a key role in the management of ADRs. To assess the pharmacist’s knowledge, attitudes and behavior of ADRs among community and hospital pharmacists in Gujarat, a validated questionnaire was developed and used to assess the understanding, attitudes and behavior of community and hospital pharmacists. 166 community pharmacists and 37 hospital pharmacists agreed to complete the ADR questionnaire. According to the study, the response of male pharmacists was higher than that of female pharmacists. In response to knowledge and practice, only the proportion of community pharmacists reporting ADR was 25 %, far lower than hospital pharmacists, who reported 65 %. Factors that encouraged the pharmacist to report ADR were the incredibly potent drug reactions, responses to the new product, and also well-recognized drug reactions documented in this study. In this study, 35 (94 %) hospital and 118 (75 %) community pharmacists guided and advised patients on their side-effects; while 25 (68 %) hospital and 115 (70 %) community pharmacists advised patients on what to do if they developed side-effects. The results of this study suggest that community pharmacists and hospital pharmacists in Gujarat need to improve their knowledge of the ADR. Pharmacists, on the other hand, should be participating in ADR awareness-raising events and refresher courses.

Estimating Culprit Drugs for Adverse Drug Reactions Based on Bayesian Inference.

The utility of big data in spontaneous adverse drug reactions (ADRs) reporting systems has improved the pharmacovigilance process. However, identifying culprit drugs in ADRs remains challenging, although it is one of the foremost steps to managing ADRs. Aiming to estimate the likelihood of prescribed drugs being culprit drugs for given ADRs, we devised a Bayesian estimation model based on the Japanese Adverse Drug Events Reports database. After developing the model, a validation study was conducted with 67 ADR reports with a gross of 1,387 drugs (67 culprit drugs and 1,320 concomitant drugs) prescribed and recorded at Yamaguchi University Hospital. As a result, the model estimated a culprit drug of ADRs with acceptable accuracy (area under the receiver operating characteristic curve 0.93 (95% confidence interval 0.88-0.97)). The estimation results provided by the model to healthcare practitioners can be used as one clue to determine the culprit drugs for various ADRs, which will improve the management of ADRs by shortening the treatment turnaround time and increasing the precision of diagnosis, leading to minimizing the adverse effects on patients.

Severity and Management of Adverse Drug Reactions Reported by Patients and Healthcare Professionals: A Cross-Sectional Survey

Adverse drug reaction (ADR) severity levels are mainly rated by healthcare professionals (HCPs), but patient ratings are limited. This study aimed to compare patient-rated and pharmacist-rated ADR severity levels and determined methods employed for ADR management and prevention by patients and HCPs. A cross-sectional survey was conducted in outpatients visiting two hospitals. Patients were asked about ADR experiences using a self-administered questionnaire, and additional information was retrieved from the medical records. In total, 617 out of 5594 patients had experienced ADRs (11.0%), but 419 patients were valid (68.0%). Patients commonly reported that their ADR severity level was moderate (39.4%), whereas pharmacists rated the ADRs as mild (52.5%). There was little agreement between patient-rated and pharmacist-rated ADR severity levels (κ = 0.144; p < 0.001). The major method of ADR management by physicians was drug withdrawal (84.7%), while for patients, it was physician consultation (67.5%). The main methods for ADR prevention by patients and HCPs were carrying an allergy card (37.2%) and recording drug allergy history (51.1%), respectively. A higher level of ADR bothersomeness was associated with higher ADR severity levels (p < 0.001). Patients and HCPs rated ADR severity and used ADR management and prevention methods differently. However, patient rating of ADR severity is a potential signal for severe ADR detection of HCPs.

Development and application of Adverse drug reactions reports QUality Algorithm (AQUA-12) score: a single-centre quality improvement initiative

PurposeTo develop a reliable assessment tool to monitor the quality of adverse drug reaction (ADR) reports and evaluate its performance within a quaternary hospital setting. MethodsAdverse drug reactions report QUality Algorithm (AQUA-12) was developed by a multidisciplinary team with the expertise in the management of ADRs. The design was based on data elements required to establish medication causality. Inter-rater reliability of AQUA-12 was evaluated over three rounds in two phases: development and prospective evaluation phases, by independent assessors both internal and external to the institutional ADR review processes. The characteristics and quality of ADR reports were subsequently assessed, and potential factors contributing to low-quality reports were identified.ResultsA total of 70 ADR reports were assessed, 20 in development and 50 in evaluation phases. The inter-rater reliability of AQUA-12 was found to be excellent in all three rounds (Cronbach’s alpha of ≥ 0.9, p < 0.001 for all). Approximately one in five reports concerned immediate hypersensitivity reactions while delayed hypersensitivity reactions constituted 60% of all reactions. AQUA-12 identified 18 (25.7%) reports as ‘low-quality’ with a score of < 10. Identification of suspected medications (37.1%), description of index ADR (27.1%), and key events (ADR narrative, 35.7%) were the top data elements incomplete or missing from all reports. Univariable analyses identified the severity of the reaction as a factor associated with low quality of reports (p = 0.008).ConclusionsAQUA-12 is a practical and highly reliable assessment tool that can be utilised in hospital settings to regularly monitor the completeness of ADR reports to guide quality improvement initiatives.

Hospital admissions attributed to adverse drug reactions in tertiary care in Uganda: burden and contributing factors.

Adverse drug reactions (ADRs) contribute to the burden of disease globally and of particular concern are ADR-related hospital admissions. This study sought to determine the burden, characteristics, contributing factors and patient outcomes of ADRs that were the primary diagnosis linked to hospital admission among inpatients in Uganda. We conducted a cross-sectional secondary analysis of data from a prospective cohort study of adult inpatients aged 18 years and older at Uganda's Mulago National Referral Hospital from November 2013 to April 2014. We reviewed clinical charts to identify inpatients with an ADR as one of the admitting diagnoses and, if so, whether or not the hospital admission was primarily attributed to the ADR. Logistic regression was used to determine factors associated with hospital admissions primarily attributed to ADRs. Among 762 inpatients, 14% had ADRs at hospital admission and 7% were primarily hospitalized due to ADRs. A total of 235 ADRs occurred among all inpatients and 57% of the ADRs were the primary diagnosis linked to hospital admission. The majority of ADRs occurred in people living with HIV and were attributed to antiretroviral drugs. HIV infection [aOR (adjusted odds ratio) = 2.97, 95% confidence interval (CI): 1.30-6.77], use of antiretroviral therapy (aOR = 5.46, 95% CI: 2.56-11.68), self-medication (aOR = 2.27, 95% CI: 1.14-4.55) and higher number of drugs used (aOR = 1.13, 95% CI: 1.01-1.26) were independently associated with hospital admissions attributed to ADRs. Antiretroviral drugs were often implicated in ADR-related hospital admissions. HIV infection (whether managed by antiretroviral therapy or not), self-medication and high pill burden were associated with hospital admissions attributable to ADRs. The high HIV burden in Sub-Saharan Africa increases the risk of ADR-related hospitalization implying the need for emphasis on early detection, monitoring and appropriate management of ADRs associated with hospital admission in people living with HIV.

A study of reporting pattern of adverse drug reactions in a tertiary care teaching hospital

Background: Adverse drug reactions (ADRs) are one of the prime causes of morbidity and mortality, increase in hospital stay and socioeconomic burden on the patients. Periodic monitoring aids in formulating methods for safe usage of medicines in hospitals. Identification of ADRs and their reporting pattern can provide useful information for their prevention. Hence this study was done to see the pattern of reported ADRs in Patna Medical College and Hospital, Patna in a 3 months of study.Methods: It was an observational and retrospective study carried out between July 2022 to September 2022. Both outpatients and inpatients were included in the study. The ADRs in the form of Individual Case Safety Reports (ICSRs) were sent to the nearby adverse drug reaction monitoring centre (AMC).Results: The occurrence of ADRs was more common in females (56.25%) as compared to males (43.75%). Patients of age-group 21-40 years (40.625%) were most commonly involved. Medicine department (34.375%) reported the maximum percentage of ADRs. Antimicrobials (37.50%) was the most common drug-group causing ADRs. Maximum reported ADRs (81.25%) were probable, 9.375% were possible, 6.25% were certain, while 3.125% were unlikely with the suspected drug as per Naranjo scale.Conclusions: The pattern of ADRs reported in our hospital is comparable with the results of studies conducted in hospital setup elsewhere, along with a few differences. The study results revealed opportunities for interventions in ADR management especially for the preventable ADRs to ensure safer drug use.

Pharmacist-led olaparib follow-up service for ambulatory ovarian cancer patients: A prospective study in a tertiary specialized cancer hospital in China.

Purpose: To establish a pharmacist-led olaparib follow-up program for ovarian cancer patients, provide patient education, get information on adverse drug reactions (ADRs), and identify and manage drug-related problems. Methods: Ambulatory adult patients with ovarian cancer receiving olaparib were enrolled. At least one follow-up session was conducted by clinical pharmacists. Pharmacists collected data on the type and grade of ADRs, drug adherence, olaparib dosing, concomitant medications, and pharmacists' suggestions. Results: 83 patients were enrolled with the median age of 58. The average number of the follow-up sessions provided to each patient was 1.31, and the average duration of each follow-up was 17.78min. The olaparib starting dose for most patients (97.59%) was 600mg/d. 36.14% of the patients had missed olaparib doses and 27.71% of the patients had dose adjustments due to ADRs. The most common ADRs (incidence≥10%) were: fatigue (40.96%), anemia (36.14%), leukopenia (36.14%), nausea (28.92%), thrombocytopenia (16.87%), anorexia (16.87%), dyspepsia (15.66%). The tolerability profiles were generally similar between patients treated for "first-line maintenance" and those treated for "recurrence maintenance" (p > .05). There were 42% of the patients who were concomitantly taking medications without exact chemical contents (such as formulated Chinese medicines and Chinese decoctions), and common types of concomitant medications with exact drug names were antihypertensive, anti-hyperglycemic, and anti-hyperlipidemic medications. The pharmacists identified 4 clinically significant drug-drug interactions (DDIs) in two patients. Pharmacists made 196 suggestions mainly related to rational use of the medications and management of ADRs. Conclusion: The study provides the first report about pharmacist-led follow-up service for olaparib. The types of ADRs were similar to those previously observed in clinical trials, and the profiles of ADRs in different types of patients (first-line maintenance vs. recurrence maintenance) were also similar. Pharmacists identified drug-related problems (such as adherence, DDIs and management of ADRs) and offer suggestions for the patients.

Pattern of adverse drug reactions to anticancer drugs at an apex hospital in south India: A retrospective study

Cancer chemotherapy is rampant as cancer is the 2nd most common cause of global mortality. It is challenged by a horde of adverse drug reactions (ADRs) and adverse events. A proper study of these ADRs is very crucial to limit their occurrences and thereby ameliorate the sufferings of the patients. Our study was to assess the frequency, nature and profile of the ADRs with anticancer drugs. A retrospective analysis of the ADR data collected over a period of 5 years was considered. Demography, drug related changes and clinical details of the patients were recorded and analysed. A total of 1145 ADR events were reported during the study period of January 01, 2017 to December 31st 2021 of which 232 cases (20.26 %) were due to anticancer drugs. The majority of the ADRs were accounted in females and in the elderly age group (&amp;#62;60 years). The commonly reported ADRs included breathing difficulty, chest discomfort, itching all over the body, numbness, neuropathy, mucositis and hand foot syndrome. The most common drugs that caused ADRs were Platinum coordination complex drugs, Taxanes, Rituximab and pyrimidine antagonists like Capecitabine and Gemcitabine. Causality assessment done using WHO-Uppsala Monitoring Centre causality assessment scale which showed 69.4% cases as “probable”, 29.3% cases as “possible” and 1.3% as “certain”. Severity assessed using the modified Hartwig and Siegel scale showed most of the cases as of moderate severity. Most of the ADR events in our study was manageable although a few required the withdrawal of the causative drug. Rigorous monitoring and adequate reporting are very crucial for the prompt identification, assessment and timely management of ADRs in the patients receiving chemotherapy so as to improve the quality of life in these patients.