Management Of Adverse Drug Reactions Research Articles

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.

Twenty-First Century Global ADR Management: A Need for Clarification, Redesign, and Coordinated Action.

Adverse drug reactions (ADRs) are estimated to be between the fourth and sixth most common cause of death worldwide, taking their place among other prevalent causes of mortality such as heart disease, cancer, and stroke. ADRs impact a broad range of populations across a wide variety of global geography and demographics, with significant mortality and morbidity burden in vulnerable groups such as older people, pediatric populations, and individuals in low-income settings. Too large a share of medicines risk management remains limited to signal detection in big ADR databases (USFDA, EMA, WHO, etc.) This resource allocation is antiquated and applied statistical signal detection methodologies have reached their limits of usefulness. In addition, existing databases are designed for short-term reactions, closely related to medication use and, thus, can only partially assess important broader consequences across geography, time, and clinical relevance. There is an urgent need change the dynamic. We need to identify (earlier and more regularly) many of the important but often overlooked or missed ADRs. Rather than assigning blame, we need to identify the root causes of the problem so they can be clearly addressed and fixed. The public health implications are profound—particularly as we recognize the importance of predicting and mitigating the next pandemic. Consequently, medicines risk management must be integrated within a broader global public health vision. To accomplish this, we need to develop the new tools and methodologies critical to assessing these public health imperatives.

Exploring Healthcare Professionals' Practices and Attitudes towards Monitoring and Reporting of Severe Adverse Drug Reactions.

Healthcare professionals (HCPs) play a key role in the monitoring of severe adverse drug reactions (ADRs). The present study aims to explore practices and barriers of HCPs in severe ADR monitoring and reporting, to evaluate their attitudes towards the monitoring and to assess the related factors. Self-administered questionnaires produced in hard copy and Google form were sent to 510 HCPs by stratified random sampling. Of the 350 HCPs that responded (68.6%), 44.9% had ever monitored ADRs. The most common practices were the observation of abnormal symptoms for ADR identification (88.5%), discontinuation of the suspected drug for ADR management (88.5%) and advice on recurrent drug allergy for ADR prevention (88.5%). Most HCPs (93.0%) obtained further patient history to identify severe ADRs. The uncertainty of the causal relationship was a major barrier to ADR reporting (60.0%). Pharmacists were more involved with practices in ADR monitoring and reporting (OR 20.405; p < 0.001), whereas longer work experience (>20 years) was negatively related to the practices (OR 0.271; p = 0.024). Over one-third (37.6%) of HCPs had a positive attitude towards severe ADR monitoring. In conclusion, the practices in severe ADR monitoring varied among different professions. However, the barriers to the reporting of ADRs still exist; hence, improving knowledge and cooperation among HCPs should be promoted.

Identification of hand-foot syndrome from cancer patients' blog posts: BERT-based deep-learning approach to detect potential adverse drug reaction symptoms.

Early detection and management of adverse drug reactions (ADRs) is crucial for improving patients’ quality of life. Hand-foot syndrome (HFS) is one of the most problematic ADRs for cancer patients. Recently, an increasing number of patients post their daily experiences to internet community, for example in blogs, where potential ADR signals not captured through routine clinic visits can be described. Therefore, this study aimed to identify patients with potential ADRs, focusing on HFS, from internet blogs by using natural language processing (NLP) deep-learning methods. From 10,646 blog posts, written in Japanese by cancer patients, 149 HFS-positive sentences were extracted after pre-processing, annotation and scrutiny by a certified oncology pharmacist. The HFS-positive sentences described not only HFS typical expressions like “pain" or “spoon nail”, but also patient-derived unique expressions like onomatopoeic ones. The dataset was divided at a 4 to 1 ratio and used to train and evaluate three NLP deep-learning models: long short-term memory (LSTM), bidirectional LSTM and bidirectional encoder representations from transformers (BERT). The BERT model gave the best performance with precision 0.63, recall 0.82 and f1 score 0.71 in the HFS user identification task. Our results demonstrate that this NLP deep-learning model can successfully identify patients with potential HFS from blog posts, where patients’ real wordings on symptoms or impacts on their daily lives are described. Thus, it should be feasible to utilize patient-generated text data to improve ADR management for individual patients.

Clinical Impact of Implementing a Nurse-Led Adverse Drug Reaction Profile in Older Adults Prescribed Multiple Medicines in UK Primary Care: A Study Protocol for a Cluster-Randomised Controlled Trial.

(1) Aims: Adverse drug reactions (ADRs) particularly affect older people prescribed multiple medicines. The professional bodies of nursing, medicine and pharmacy have issued guidelines on identification and management of ADRs; however, ADRs continue to account for ~10% unplanned hospital admissions in the UK. Current methods of ADR identification and management could be improved by multidisciplinary collaboration involving nurses. The aim of this study is to examine the impact of implementing the nurse-led Adverse Drug Reaction (ADRe) Profile in UK primary care. (2) Design: A pragmatic cluster-randomised controlled trial (RCT) followed by qualitative interviews in a sequential mixed-methods study. (3) Methods: For the cluster RCT, 60 patients aged ≥65 prescribed ≥5 regular medicines for long-term conditions will be recruited, 10 in each of 6 general practices. The intervention arm (n = 30) will complete the ADRe Profile, whilst the control participants (n = 30) continue to receive usual, standard care. Primary outcomes will include clinical impact on patients, benefit and prescription changes. On completion of the RCT, participants will be invited to semi-structured qualitative interviews, to evaluate the impact of the ADRe Profile from stakeholders’ perspectives, and to describe the contextual factors relevant to ADRe implementation. (4) Results: The findings of this study will evaluate the effectiveness of the ADRe Profile in identifying and resolving potential ADRs in primary care. Trial registration: This study was registered in ClinicalTrials.gov, registration number NCT04663360, date of registration—29 November 2021 (date of initial registration: 26 November 2020), protocol version 2, dated 8 January 2021.

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.