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The article presents abstracts of papers presented at the 39th European Society of Clinical Pharmacy (ESCP) European Symposium on Clinical Pharmacy and the 3th Société Française de Pharmacie Clinique (SFPC) Congress: Clinical Pharmacy at the Front Line of Innovations in Lyon, France, including "Hallucinations Due to Therapeutic Doses of Ertapenem," "Carboplatin Dosage in Overweight Patient: Case Report" and "Severe Hypokalemia Associated With Flucloxacillin."

Background: The Yellow Card Scheme was created in 1964 to oversee new and existing medicines and medical devices, and act as an early warning system for unexpected adverse drug reactions (ADRs). Under-reporting within the system is a known issue, estimated to be as high as 94% in a 2006 systematic review. Anticoagulants are often prescribed in the UK to prevent stroke in patients with atrial fibrillation but can be associated with gastrointestinal bleeding as a common ADR. Aim: The study aimed to investigate the incidence of suspected DOAC-related GI bleeds at a North-West England hospital and explore the volume of these incidents reported through the MHRA Yellow Card Scheme, over a 5-year period. Method: Hospital coding data was used to identify patient records with GI bleeding and cross-referenced with electronic prescribing records for anticoagulant usage. Additionally, pharmacovigilance reporting activity for the Trust was obtained from the MHRA Yellow Card Scheme. Results: For the period investigated, the Trust recorded 12,013 GI bleed related emergency admissions. Of these admissions, 1058 patients were taking a DOAC. During the same time period, a total of 6 DOAC-related pharmacovigilance reports were made by the trust. Conclusion: Utilisation of the Yellow Card System for reporting potential ADR is poor, leading to under-reporting of ADRs. [ABSTRACT FROM AUTHOR]

Background: Algorithms for causality assessment of adverse drug reactions (ADRs) in a neonatal intensive care unit (NICU) are important in the management of adverse events, however, it is inconclusive which tool best suits pharmacovigilance in neonates. Aim: To compare the performance of the algorithms of Du and Naranjo in determining causality in cases of ADRs in neonates in a NICU. Method: This observational and prospective study was conducted in a NICU of a Brazilian maternity school between January 2019 and December 2020. Independently, three clinical pharmacists used the algorithms of Naranjo and Du in 79 cases of ADRs in 57 neonates. The algorithms were evaluated for inter-rater and inter-tool agreement using Cohen's kappa coefficient (k). Results: The Du algorithm showed greater ability to identify definite ADRs (≈ 60%), but had low reproducibility (overall k = 0.108; 95% CI 0.064–0.149). In contrast, the Naranjo algorithm showed a lower proportion of definite ADRs (< 4%), but had good reproducibility (overall k = 0.402; 95% CI 0.379–0.429). The tools showed no significant correlation regarding ADR causality classification (overall k = − 0.031; 95% CI − 0.049 to 0.065). Conclusion: Although the Du algorithm has a lower reproducibility compared to the Naranjo, this tool showed good sensitivity for classifying ADRs as definite, proving to be a more suitable tool for neonatal clinical routine. [ABSTRACT FROM AUTHOR]

Background: Only 5–10% of all adverse drug reactions (ADRs) are reported. Mechanisms to support patient and public reporting offer numerous advantages to health care systems including increasing reporting rate. Theory-informed insights into the factors implicated in patient and public underreporting are likely to offer valuable opportunity for the development of effective reporting-interventions and optimization of existing systems. Aim: To collate, summarize and synthesize the reported behavioral determinants using the theoretical domains framework (TDF), that influence patient and public reporting of ADRs. Method: Cochrane, CINAHL, Web of science, EMBASE and PubMed were systematically searched on October 25th, 2021. Studies assessing the factors influencing public or patients reporting of ADRs were included. Full-text screening, data extraction and quality appraisal were performed independently by two authors. Extracted factors were mapped to TDF. Results: 26 studies were included conducted in 14 countries across five continents. Knowledge, social/professional role and identity, beliefs about consequences, and environmental context and resources, appeared to be the most significant TDF domains that influenced patient and public behaviors regarding ADR reporting. Conclusion: Studies included in this review were deemed of low risk of bias and allowed for identification of key behavioural determinants, which may be mapped to evidence-based behavioral change strategies that facilitate intervention development to enhance rates of ADR reporting. Aligning strategies should focus on education, training and further involvement from regulatory bodies and government support to establish mechanisms, which facilitate feedback and follow-ups on submitted reports. [ABSTRACT FROM AUTHOR]

Background: Adverse drug reactions are a problem in healthcare systems worldwide. Children are more susceptible than adults, especially when exposed to specific drug classes, such as antibiotics. Objective: To assess the incidence, causality, severity, and avoidability of antibiotic-associated adverse drug reactions in hospitalized pediatric patients. Setting: Pediatric ward of a high-complexity public hospital in northeast Brazil. Methods: A prospective cohort study was conducted over six months, including children aged between 28 days and 12 years, hospitalized for more than 48 h, and receiving antibiotics. Liverpool's causality and avoidability assessment tools were used. Primary outcome measures: Incidence of adverse drug reactions, causality, severity, and avoidability, major antibiotics implicated, risk factors. Results: A total of 183 patients were followed, and 35 suspected adverse drug reactions were recorded overall incidence equal to 14.7%. Most adverse drug reactions were classified as moderate severity (76.7%), probable (57.1%) and defined (28.6%) causality, and unavoidable (66.7%). The affected organs were the gastrointestinal system (74.1%) and skin (25.9%). Major antibiotics implicated were ceftriaxone (40.7%), azithromycin (25.9%), and crystalline penicillin (11.1%). The number of antibiotics prescribed per patient during hospitalization and the length of stay were the risk factors identified. Conclusion: Causality and severity assessment indicated that most adverse drug reactions were probable and moderate. Possibly avoidable reactions occurred due to inappropriate prescribing when preventive measures were not implemented. Monitoring the use of antibiotics in children is essential to ensure the safety of these patients. [ABSTRACT FROM AUTHOR]

Case: A case study of a patient who over complied with adjuvant capecitabine monotherapy on several occasions is described. The patient suffered worsening side effects, predominantly palmar plantar erythrodysesthesia which resulted in dose reduction and delay. The patient had disregarded advice to stop taking the capecitabine as he perceived it as 'important to fight his cancer'. The patient refused review with a psychologist. Conclusion: There is a lack of evidence regarding the issue of over compliance. Pharmacists should consider discussing patient's attitudes towards taking their medication and its importance to them in treating their cancer. Tools that are used to assess non-compliance could be utilised to identify patients who over comply. Further research is required to gain further understanding of the psychological factors behind patient's decisions to over comply with treatment. [ABSTRACT FROM AUTHOR]

Background Adverse reactions to warfarin may be serious and can lead to hospitalisation or death. Minimising the risk of adverse drug reactions through the intervention of community pharmacists is important for patients receiving warfarin, especially for elderly (≥ 65 years) patients living in rural areas. Objective To evaluate the impact of an intervention by community pharmacists on the risk of adverse drug reactions in elderly rural patients receiving warfarin. Setting: A community pharmacy in a rural area of Croatia. Method We conducted a prospective randomised trial. Eligible patients were recruited at the pharmacy and randomised into one of two groups. The participants were followed up every month for 6 months. Main outcome measure: The incidence and type of adverse drug reactions caused by warfarin and the time-to-event. Results In total, 140 patients were randomized and 131 patients completed the study; 65 patients were in the intervention group. The median age of patients was 73 years of age. The cumulative incidence of adverse drug reactions was significantly lower in the intervention group (6-months rate 29% vs. 85% for intervention and control, respectively; hazard ratio = 0.17, p < 0.001) than in the control group. Factors multivariately associated with the development of adverse drug reactions related to warfarin (p < 0.05) were the absence of pharmaceutical intervention, higher time in therapeutic range, change of warfarin dose, changes in dietary vitamin K intake, and marital status other than married. Conclusion Overall, the pharmacist's intervention significantly prolonged the time to occurrence of adverse drug reactions and reduced their incidence. [ABSTRACT FROM AUTHOR]

Background Adverse drug reactions (ADRs) monitoring in cancer patients is important to ensure early detection, effective management and possible prevention subsequently. Objectives This study was conducted to detect and monitor ADRs to anti-cancer agents, and to assess impact of clinical pharmacists (CPs)' interventions in minimizing ADRs to anti-cancer agents. Setting Private, specialty oncology care hospital in South India. Methods CPs prospectively followed cancer patients admitted to inpatient wards and treated at ambulatory care in order to identify ADRs, for a period of 3 years. Identified/reported ADRs were discussed with concerned oncologists and/or nurses, documented electronically and assessed further for their causality, severity, preventability and grading. Based on study findings during year 1, interventions (educational, therapeutic and system based) were developed by CPs and implemented in order to minimize preventable ADRs. Impact of CPs' interventions was studied during year 2 and year 3. Main outcome measure(s) Preventable factors contributing to ADRs and percentage of preventable ADRs before and after CPs' interventions. Results A total of 1279 ADRs were reported in 1133 patients from a cohort of 1328 patients. Vomiting (23.22%), alopecia (9.53%), diarrhoea (8.67%) and myelosuppression (7.42%) were the common ADRs reported. Inappropriate administration frequency and regimen of anti-emetics (22%), lack of/suboptimal supportive care (18%) and administration errors (16%) were identified as common contributing (preventable) factors for ADRs in year 1. Percentage of preventable ADRs was 81% during year 1 (pre-intervention), and 45% and 34% in year 2 and year 3 respectively (post-interventions). Conclusion Interventions by CPs helped to minimize preventable ADRs to anti-cancer agents. [ABSTRACT FROM AUTHOR]

Background Rational drug use and drug safety are becoming increasingly important concerns in China with the increasing public access to drugs and the health-care system, and this has led to the development of pharmacovigilance in China. Aim of the review To provide a brief introduction about pharmacovigilance in China in terms of system development, utilization and challenges. Method Relevant studies on pharmacovigilance related to the study aim was undertaken through literature search to synthesize the extracted data. Results The creation and evolvement of China's pharmacovigilance system spans across 30 years since 1989. The system consists of four progressing administrative layers: county, municipal, provincial and national levels. China has passed over 20 laws and regulations related to pharmacovigilance covering the processes of drug development, manufacture, distribution and use with the aim to guard drug safety. An online spontaneous self-reporting Adverse Drug Reaction (ADR) Monitoring System was established in 2003. ADRs are mainly reported by medical institutions, pharmaceutical manufacturers, and drug distributors. Currently there is no mandatory ADR reporting requirement for pharmaceutical manufacturers, and a proposed regulation under public comment will likely change this. China has started to build active pharmacovigilance surveillance programs in addition to the passive ADR reporting system. The China Food and Drug Administration has established the intensive Safety Monitoring Program and the National Adverse Drug Reaction Monitoring Sentinel Alliance Program based on electronic health records to further the efforts of ADR reporting, monitoring and analysis. Conclusion The practice of ADR monitoring and pharmacovigilance in China have made great progress. More efforts are needed both in system building, and creation of laws and regulations to strengthen the safe use of medicines. [ABSTRACT FROM AUTHOR]

Background Pharmacovigilance, as it is carried out primarily by healthcare professionals is more focused on being very objective in nature. Acknowledging the importance of the subjective experience of patients in pharmacovigilance was underpinned by its unique ability to bring about a more holistic understanding through the deep information unraveled by the patients. Medication safety-related information has to be shared with patients to allow them to be actively involved in their therapy and pharmacovigilance. Despite the advantages of sharing information, it stands to reasons whether sharing information related to possible side effects would negatively affect patients and impinge upon their treatment plan and process. Aim of the Review The purpose of this systematic review was to critically assess the potential negative impact of informing patients about medication side effects by written and/or oral information on medication compliance, occurrence/development of suspected side effects and clinical outcomes. Method A comprehensive search was conducted in PubMed, and Cochrane library to identify potential records between the year 1975 and 2017; then titles, abstracts, and full texts were screened using the inclusion criteria to filter out irrelevant studies. The data extraction, and the results were narratively synthesized and presented in tables. Results A total of 2012 articles were screened for inclusion, 32 full-text articles were assessed for eligibility and finally resulting in the inclusion of 17 randomized control studies which met the set criteria. Findings unraveled that the educational intervention did not result in increased occurrence/reporting of side effects in most of the evaluated studies; except 4 studies, and no significant impact on compliance to medications and negative clinical outcome was observed. Apprehension of negative events to medications were observed in two of the four studies which evaluated these parameters. Conclusion The present review did not find enough evidence to support the over concerns on the potential negative impact of sharing of information on the adverse effects to patients, though the influence could manifest as nocebo-effect. The various components and methods employed for this information sharing process can influence the potential impact of this activity. These concerns about the undesirable effects should not deter the active involvement of patients in pharmacovigilance activities. There is a definite need to have more studies in this area, where much of concern still does exist among the various stakeholders of drug safety information. [ABSTRACT FROM AUTHOR]

Background Side effects of cancer therapy are one of the most important issues faced by cancer patients during their illness. Pharmacovigilance, namely the science and activities aimed at monitoring the safety of drugs, is particularly important in oncology, due to the intrinsic biologic toxicity of antineoplastic agents, their narrow therapeutic windows, and the high doses and rigid timing of treatment regimens. Aim of the review To identify the main issues in carrying out an effective pharmacovigilance activity in oncology. Method We searched PubMed for articles about pharmacovigilance in relation to chemotherapy, radiotherapy and targeted therapy for cancer, using MeSH terms and text words. We also searched Embase, CINAHL, Scopus, Micromedex, the Cochrane Library, two pharmacovigilance databases and the gray literature for articles published in 2012-2018. Overall, 137 articles were considered potentially relevant and were critically appraised independently by two authors, leading to the inclusion of 44 relevant studies, guidelines and reviews. Another 10 important research reports were included in the review. Results Eight critical issues of pharmacovigilance in oncology were identified. These issues pertain to: terminology; range of side effects; targeted therapy and immunotherapy; chemoradiotherapy; generic drugs and biosimilars; drug interactions, pharmacogenetics and polypharmacy; special patient categories; and under-reporting of ADRs. Conclusion The importance of pharmacovigilance in oncology must be highlighted with every effort, to improve safety and offer cancer patients every possible help to improve their quality of life during such a critical period of their lives. [ABSTRACT FROM AUTHOR]

Adverse Drug Reactions (ADRs) are major global concern, adversely impacting patient safety and health outcomes. ADRs cause significant morbidity and mortality among hospitalised patients, causing greater length of hospital stay, increased healthcare costs and patient dissatisfaction to the treatments. Pharmacovigilance (PV), a process of detecting, monitoring and preventing drug-related harm, plays a vital role to ensure patient safety. ADR reporting is the cornerstone of PV. PV practices in Qatar are relatively new and are evolving rapidly. The purpose of this article is to explore the medication safety practices (notably ADR reporting) at the largest academic healthcare center in Qatar. The article further provides evidence on how information related to ADRs are generated and interpreted. Furthermore, it describes how a designated center for monitoring medication safety activities was established at the largest healthcare provider in Qatar. [ABSTRACT FROM AUTHOR]

Background Respiratory medications are frequently prescribed for use in children. Several studies have reported information on the safety of asthma medications in clinical studies in adults, but information about safety in children is scarce. Objective To review published clinical trials on the occurrence and characteristics of adverse drug reactions (ADRs) in children, reported for asthma medications licensed for paediatric use. Methods We systematically reviewed the literature following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement guidelines. PubMed, Embase, Cochrane Library, PsycINFO, IPA, and CINAHLs databases were searched from origin until July 2013 for studies reporting ADRs for beta2-receptor agonists, inhaled corticosteroids, leukotriene receptor antagonists and combination products in children from birth to age 17. Information on ADR reporting rates, age and gender, type and seriousness of ADRs, design, setting, observation period, type of assessors, and funding sources was extracted from the articles. Results Literature searches resulted in 162 potential relevant articles. However only 12 of these studies were included in this review as they reported information about ADR rates from use of salmeterol, formoterol, fluticasone, montelukast, zafirlukast and budesonide/formoterol in children. The total population was approximately 3,000 children; the majority was 6- to 11-year-olds and two thirds of these were boys. The observation period varied from 1 to 22 months. The most frequently reported ADRs were exacerbation of asthma, respiratory tract infection, cough, fever and headache. Only few ADRs were rated as being serious, however a number of children dropped out of the clinical trials due to serious ADRs, and, therefore, the real number of serious ADRs is probably higher. Conclusions Few clinical trials reporting ADRs from use of asthma medications in children were identified in the literature. These studies reported only a few types of ADRs, the majority being non-serious. [ABSTRACT FROM AUTHOR]

Background Adverse drug reactions are a major public health problem. Underreporting is an important limitation of all reporting systems, partially due to attitudes of health professionals. Objective This study sought: (1) to evaluate the reproducibility of a questionnaire on attitudes to and knowledge of adverse drug reaction (ADR) reporting among physicians, nurses and pharmacists: and (2) to compare the attitudes and knowledge of these three groups of health professionals. Methods This study targeted a sample of physicians (n = 30), nurses (n = 30) and pharmacists (n = 20) in the central region of Portugal. A structured questionnaire was administered to each health professional twice, at an interval of 2-4 weeks. Most attitudes were based on Inman's 'seven deadly sins' and measured using a continuous visual analog scale (VAS), with answers scored from 0 (total disagreement) to 10 (total agreement). Questionnaire reproducibility was determined using the intraclass correlation coefficient (ICC). Results The response rate was 100 %. Attitudes that registered the highest ICCs were Complacency (the belief that really serious ADRs are well documented by the time a drug is marketed) (physicians, ICC 0.84; nurses, ICC 0.70; pharmacists, ICC 0.99), and Diffidence (the belief that one would only report an ADR if one were sure that it was related to the use of a particular drug) (physicians, ICC 0.73; nurses, ICC 0.65; pharmacists, ICC 0.98). In most cases, there were no differences among the three groups of professionals in terms of attitudes and knowledge. Conclusions The Horizontal continuous VAS is reliable to detect the knowledge and attitudes about ADRs. [ABSTRACT FROM AUTHOR]

Objective The aim of this study was to assess the situation regarding spontaneous adverse drug reaction reporting in the Czech Republic during a 5-year period (2005-2009). Setting descriptive study was conducted using the data from the Czech State Institute for Drug Control pharmacovigilance database. Methods The data referring to all spontaneous adverse drug reaction reports received, by the pharmacovigilance department of the Czech State Institute for Drug Control during 2005-2009 were collected, analysed and compared with data from the Slovak Republic, Denmark, and the United Kingdom. Main outcome measures The number of received spontaneous adverse drug reactions reports by year per 10,000 inhabitants, the seriousness and outcome of reactions, the reporting groups, and the top ten molecules which contributed to the highest number of reports. Results During the study period 2005-2009, the pharmacovigilance department of the State Institute for Drug Control received 7,708 spontaneous adverse drug reactions reports of which 73.6% were serious and 2.1% resulted in death. The number of spontaneous adverse drug reactions reports per 10,000 inhabitants ranged from 1.3 to 1.7, which was lower when compared with the number of reports from three other EU countries. The healthcare professionals contributed to 64.2% of the adverse drug reactions reports, whilst marketing authorization holders provided 35.5%, and finally patients with 0.3%. Vaccines, ketoprofen, amoxicillin, statins, and estradiol were amongst the top ten molecules that gave the highest number of spontaneous adverse drug reactions reports. Conclusions Our assessment of adverse drug reactions spontaneous reports received by the Czech Institute for Drug Control during 2005-2009 showed that the reporting rate is relatively low and remains constant over the 5 year period. More emphasis on academic/professional training is needed to educate all potential reporters on the mechanism of reporting of adverse drug reactions and to also emphasize the importance of the whole pharmacovigilance process. [ABSTRACT FROM AUTHOR]