Pharmacovigilance Activities Research Articles

Adverse Drug Reactions to β-Lactam Antibiotics: A Portuguese Pharmacovigilance Database Analysis

Abstract Background The β-lactam antibiotics are one of the most relevant drug classes globally. They accounted for the largest share of systemic antibiotics consumption in Portugal across both community and hospital settings. Due to their significance, continuous monitoring of adverse drug reactions (ADR) associated with β-lactams is fundamental. Aim To analyse and characterise cases related to β-lactam antibiotics received by the Portuguese National Pharmacovigilance System. Methods Retrospective analysis of cases containing at least one medicinal product classified as suspect under the Anatomical Therapeutic Chemical (ATC) code J01C or J01D, reported to the Portuguese Pharmacovigilance System between 2014 and 2023. Characterisation of cases considered patient demographics, reported suspected medicines, MedDRA Preferred Term (PT), seriousness and type of reporter. Results A total of 3557 cases were identified (54.0% females; median age = 42.0 years; interquartile range = 52.2), with 95.9% originating from spontaneous reporting and 93.5% being reported by healthcare professionals. The most frequently reported medicines were those belonging to ATC J01CR. Around 70% of cases were classified as serious, with 38.7% being related to situations of disability or other criteria of greater seriousness. Most frequently reported PTs were related to skin disorders. Anaphylactic reaction was the most reported Designated Medical Event term. The PTs “Drug ineffective” and “Off label use” were reported in 5.2% and 2.4% of the cases, respectively. Conclusions Despite the majority of cases are serious, most of the ADR identified are related to already known hypersensitivity reactions. To improve the knowledge regarding these medicines and to generate evidence to address emerging public health issues it is of paramount importance to strength the Portuguese Pharmacovigilance System. This can be achieved through enhancing spontaneous reporting and implementing active pharmacovigilance programs. Key messages • Monitoring the efficacy and safety profile of β-lactams in a real-world context is crucial to mitigate the impact in public health and associated economic burden. • Enhancing the surveillance systems improves data collection and evidence generation, supporting tailoring treatment approaches and implementation of public health policies.

Assessment of Knowledge, Attitude and Practice of Community Pharmacists towards Adverse Drug Reactions Reporting in Pokhara

Introduction: The pharmacovigilance activities were initiated since 2004 AD which promote Adverse Drug Reactions (ADRs) reporting in hospital-based set-up in Nepal. But the system lacks robust activities related to ADRs and its reporting on community-based pharmacy. The role of pharmacist is very essential in preventing harmful effects of medicine. Objective: The main objective of the research is to assess the knowledge, attitude and practice of community pharmacists towards ADR reporting and to correlates the KAP scores with the demographic distribution of the respondents. Methods: A cross-sectional study was carried out by using a self-administered structured questionnaire. During the study period 132 pharmacists working at community pharmacies in Pokhara were selected and they were interviewed. Results: Out of 132 pharmacies visited, with an overall response rate of 65.33%, only 87 pharmacists agreed to response. There were 56 males and 31 females. The pharmacists with post-graduation degree had a high KAP score (21.00) followed by PharmD (19.5), graduate pharmacists (19.35), and then assistant pharmacists (13.8). Conclusion: Majority of the pharmacist had relatively better attitude but good knowledge towards ADRs and pharmacovigilance. In spite of that the knowledge and attitude could not reflected on the practice of ADR reporting. The majority of respondents emphasize the reporting of ADR from ground level is essential, so that the outcome-based treatment can enhance the patient’s safety.

Assessment of the State of Pharmacovigilance in Secondary Hospitals in the Federal Capital Territory of Nigeria, Using WHO Pharmacovigilance Indicators.

The importance of pharmacovigilance (PV) in ensuring drug safety, especially in the detection and prevention of adverse drug reactions (ADRs) is critical. However, PV activities in Nigeria still face many challenges, such as very low spontaneous reporting rates, and inadequate training and funding. This study assessed the state of pharmacovigilance in the federal capital territory of Nigeria (FCT), using WHO pharmacovigilance indicators. A cross-sectional questionnaire-based survey was carried out among secondary healthcare facilities in the FCT. The WHO Pharmacovigilance Indicators Questionnaire, which consists of the structural, process and outcome measures, was used to collect data from the focal person for pharmacovigilance at all the consenting facilities. Descriptive statistics were used to summarize all variables. Ethical approval was obtained from the Ethics Review Committee of the FCT development authority. Of the 14 secondary healthcare facilities in the FCT, 11 agreed to the study (response rate = 84.6%). Among the respondents, 4 (36.4%) were females, and 2 (18.2%) had 9 years of experience in pharmacovigilance. For the core structural indicators, 7 (63.6%) of the facilities had a pharmacovigilance center while only 4 (36.4%) had a copy of the Nigerian pharmacovigilance policy. Regarding financial provisions, 10 (90.9%) hospitals reported that there was no regular financial provision for the center while 10 (90.9%) centers had a standard adverse drug reaction reporting form. For the core process indicators, the mean ± SD of the nine core process indicators ranged from 0.9 ± 3.0 to 75.6 ± 38.6 and the total number of reports in the local database, therapeutic ineffectiveness, and medication error were limited. The assessment of pharmacovigilance activities in the Federal Capital Territory of Nigeria revealed significant gaps in infrastructure, financial support, and process implementation. Despite the presence of pharmacovigilance centers in the majority of facilities, the lack of consistent financial support and limited adherence to core process indicators highlight the need for enhanced training, resources, and policy enforcement to improve ADR reporting and overall drug safety monitoring. Strengthening these areas is crucial for advancing pharmacovigilance practices and ensuring patient safety in Nigeria.

Unintentional poisoning in older Australians: a retrospective audit of New South Wales Poisons Information Centre data

Introduction Poisons information centres provide phone-based risk assessment and management advice on poisonings. Unintentional poisonings are a common reason for consulting a poisons information centre, and older adults are at increased risk of unintentional poisoning and adverse outcomes. We describe patterns of unintentional poisoning in older adults reported to a regional poisons information centre. Methods We conducted a retrospective audit of poisons information centre call records and identified unintentional poisonings involving older adults (≥75 years) over a 12-month period to determine patient demographics and poisoning circumstances (substances, contributing factors, and disposition recommendation). Univariate analyses identified variables associated with hospital referral and multivariate models to identify independent risk factors in home-dwelling older adults. Results We identified 2,757 calls. More exposures occurred in women (62%) and involved therapeutic errors (70.8%). Paracetamol was the most common drug involved (11%), and cardiovascular drugs were the most common drug class (36%). Only 14.3% of the study population was referred to hospital. Independent risk factors for hospital referral in home-dwelling older adults were exposure to cardiovascular, centrally acting and antihyperglycaemics, non-oral route of administration and symptoms at the time of the call. Discussion Unintentional poisoning is not uncommon, and our findings are similar to those in other countries over recent decades. These findings suggest that unintentional poisoning in older adults is inadequately addressed by current medication safety strategies. Our findings indicate the value of timely advice by poisons information centres for preventing potentially unnecessary hospitalizations. Conclusion Further research is needed to identify more effective approaches to medication safety strategies for older adults. Poisons information centre data contribute to pharmacovigilance activities and could inform patient care.

Strategies to enhance risk communication about medicines in Malaysia: a Delphi study among multinational experts

BackgroundEffective risk communication about medicines is crucial to the success of all pharmacovigilance activities but remains a worldwide challenge. Risk communication has been conducted in Malaysia for decades, yet awareness on the communication methods remains low among healthcare professionals. While international guidelines are available, clear guidance on effectively communicating the risks of medicines in specific countries is scarce. This study aimed to establish a consensus on the priority strategies for enhancing risk communication about medicines by regulators.MethodsWe conducted a two-round modified Delphi survey among local and international communication experts, and also recipients of medicines risk communication in Malaysia. We developed a list of 37 strategies based on the findings of our previous studies. In Round 1, participants were asked to rate the priority for each strategy using a 5-point Likert scale and suggest additional strategies via free-text comments. Strategies scoring a mean of ≥ 3.75 were included in Round 2. We defined consensus for the final list of strategies a priori as > 75% agreement. Data were analysed using descriptive statistics and thematic analysis.ResultsOur final Delphi panel (n = 39, 93% response rate) comprised medicines communication experts from nine countries and Malaysian healthcare professionals. Following Round 1, we dropped 14 strategies and added 11 strategies proposed by panellists. In the second round, 21 strategies achieved consensus. The priority areas identified were to improve the format and content of risk communication, increase the use of technology, and increase collaboration with various stakeholders. Priority ratings for the strategy “to offer incentives to pharmaceutical companies which maintain effective communication systems” were significantly higher among recipients compared to communicators [χ2(1, N = 39) = 10.1; p = 0.039] and among local versus international panellists [χ2(1, N = 39) = 14.3; p = 0.007].ConclusionsOur study identified 21 priority strategies, which were used to develop a strategic plan for enhancing medicines risk communication. This plan is potentially adaptable to all countries with developing pharmacovigilance systems. The difference in views between communicators and recipients, as well as local and international panellists, highlights the importance of involving multiple stakeholders in research.

A Comparison of Active Pharmacovigilance Strategies Used to Monitor Adverse Events to Antiviral Agents: A Systematic Review.

The safety of antiviral agents in real-world clinical settings is crucial, as pre-marketing studies often do not capture all adverse events (AE). Active pharmacovigilance strategies are essential for detecting and characterising these AE comprehensively. The aim of this study was to identify and characterise active pharmacovigilance strategies used in real-world clinical settings for patients under systemic antiviral agents, focusing on the frequency of AE and the clinical data sources used. We conducted a systematic review by searching three electronic bibliographic databases targeting observational prospective active pharmacovigilance studies, phase IV clinical trials for post-marketing safety surveillance, and interventional studies assessing active pharmacovigilance strategies, focusing on individuals exposed to systemic antiviral agents. We included 36 primary studies, predominantly using Drug Event Monitoring (DEM), with a minority employing sentinel sites and registries. Human immunodeficiency virus (HIV) was the most common condition, with the majority using DEM. Within the DEM, there was a wide range of incidences of patients experiencing at least one AE, and most of these studies used one or two data sources. Sentinel site studies were less common, with two on hepatitis C virus (HCV) and one on HIV, each relying on one or two data sources. The single study using a registry focusing on HIV therapy reported using just one data source. Patient interviews were the most common data source, followed by medical records and laboratory tests. The quality of the studies was considered 'good' in 18/36, 'fair' in 1/36, and 'poor' in 17/36 studies. DEM was the predominant pharmacovigilance strategy, employing multiple data sources, and appears to increase the likelihood of detecting higher AE incidence. Establishing such a framework would facilitate a more detailed and consistent approach across different studies and settings.

[Artículo traducido] Predicción de reacciones adversas a medicamentos en pacientes geriátricos ingresados en unidades de cuidados intensivos

IntroductionIntensive Care Units (ICUs) pose challenges in managing critically-ill patients with polypharmacy, potentially leading to Adverse Drug Reactions (ADRs), particularly in the elderly. ObjectiveTo evaluate whether the severity and clinical prognosis scores used in ICUs correlate with the prediction of ADRs in aged patients admitted to an ICU. MethodsA cohort study was conducted in a Brazilian University Hospital ICU. APACHE II and SAPS 3 assessed clinical prognosis, while GerontoNet ADR Risk Score and BADRI evaluated ADR risk at ICU admission. Severity of the patients' clinical conditions was evaluated daily based on the SOFA score. Adverse Drug Reaction (ADR) screening was performed daily through the identification of ADR triggers. Results1295 triggers were identified (median 30 per patient, IQR = 28), with 15 suspected ADRs. No correlation was observed between patient severity and ADRs at admission (p=0.26), during hospitalization (p=0.91), or at follow-up (p=0.77). There was also no association between death and ADRs (p=0.28) or worse prognosis and ADRs (p>0.05). Higher BADRI scores correlated with more ADRs (p=0.001). ConclusionsThe data suggest that employing the severity and clinical prognosis scores used in Intensive Care Units is not sufficient to direct active pharmacovigilance efforts, which are therefore indicated for critically ill patients.

Prospective,multi-center,and large-scale hospital centralized monitoring of clinical safety of Reduning Injection in 100249 children cases

This study utilized a prospective, large-sample, multi-center, and registered key specialty approach of hospitals to monitor the application of Reduning Injection. A total of 100 249 adolescent patients aged 14 years and below who received Reduning Injection were monitored, resulting in 83 cases of adverse events, with 76 of them being classified as adverse drug reaction(ADR). The calculated incidence rate of ADR for Reduning Injection was 0.076%, indicating a very rare ADR. The main symptoms of ADR were pruritus, diarrhea, abdominal pain, vomiting, high fever, dyspnea, convulsion, and chills. All ADR cases were reported for the first time, including three new ADR cases and 73 known ADR cases. The categories of ADR was general ADR. All ADR was mild in severity. There were more males than females in ADR patients. One patient had a history of ADR, and the drug causing ADR was buprofen. The largest number of ADR cases occurred when the dosage of Reduning injection was 5-10 mL. The dropping speed was 30 drops or less per min, and the solvent type was 5% glucose injection. The most common manifestation of ADR patients was pruritus, followed by diarrhea, abdominal pain, vomiting, high fever, dyspnea, convulsions, and chills. 72 patients(94.74% of ADR patients) discontinued the drug, and three patients(3.95% of ADR patients) were given oxygen inhalation. 47 cases(61.84% of ADR patients) were treated with medication, of which dexamethasone was the most used(24 cases, 46.15% of ADR patients). 76 ADR patients were cured or improved. ADRs are more likely to occur when diagnosed with acute bronchitis by western medicine and cough by traditional Chinese medicine(TCM), TCM syndrome type is wind heat syndrome, and the combination medicine is ambroxol hydrochloride and bromhexine hydrochloride injection, ascorbic acid/vitamin C injection. This result provides an evidence-based safety basis for active pharmacovigilance of Reduning Injection in adolescents aged 14 years and below.

Knowledge, attitude and practices about pharmacovigilance activities among hospital nurses: a multicentre cross-sectional survey.

The national pharmacovigilance (PV) system has been established in many countries worldwide following the thalidomide tragedy. Nurses have an important role in recognising and reporting any Adverse Drug Reaction (ADR); however, their role has not been widely explored, particularly in Southeast Asian countries. To assess the knowledge, attitudes and practice (KAP) about PV activities, along with barriers and facilitators that affect ADR reporting among hospital nurses in Malaysia. The present study also explores the relationship between demographic characteristics and predictors of KAP among hospital nurses in Malaysia. A multicentre, questionnaire-based, cross-sectional study was conducted in March-May 2021, among nurses working at tertiary care hospitals in Malaysia. The mean KAP score of study participants was 57 ± 11. Overall participants had poor ADR knowledge (37.4%), and poor reporting practices (48.9%). Age >30 years (AOR = 2.7 (1.13-6.8), p = 0.02), and working experience of greater than 10 years (AOR = 2.44 (1.08-5.52), p = 0.03), were significantly associated with good ADR knowledge and reporting practices among study participants. In summary, study findings offer valuable insight for developing targeted interventions and formal training to improve nurses' ADR knowledge and reporting practices. Addressing gaps in these areas can enhance patient safety and overall healthcare quality.

Commentary: Knowledge, attitude and practices about pharmacovigilance activities among hospital nurses: a multicentre cross-sectional survey.

Commentary: Knowledge, attitude and practices about pharmacovigilance activities among hospital nurses: a multicentre cross-sectional survey.

Active surveillance pharmacovigilance for Clostridioides difficile infection and gastrointestinal bleeding: an analytic framework based on case-control studies

Active surveillance pharmacovigilance is an emerging approach to identify medications with unanticipated effects. We previously developed a framework called pharmacopeia-wide association studies (PharmWAS) that limits false positive medication associations through high-dimensional confounding adjustment and set enrichment. We aimed to assess the transportability and generalizability of the PharmWAS framework by using medical claims data to reproduce known medication associations with Clostridioides difficile infection (CDI) or gastrointestinal bleeding (GIB). We conducted case-control studies using Optum's de-identified Clinformatics Data Mart Database of individuals enrolled in large commercial and Medicare Advantage health plans in the United States. Individuals with CDI (from 2010 to 2015) or GIB (from 2010 to 2021) were matched to controls by age and sex. We identified all medications utilized prior to diagnosis and analysed the association of each with CDI or GIB using conditional logistic regression adjusted for risk factors for the outcome and a high-dimensional propensity score. For the CDI study, we identified 55,137 cases, 220,543 controls, and 290 medications to analyse. Antibiotics with Gram-negative spectrum, including ciprofloxacin (aOR 2.83), ceftriaxone (aOR 2.65), and levofloxacin (aOR 1.60), were strongly associated. For the GIB study, we identified 450,315 cases, 1,801,260 controls, and 354 medications to analyse. Antiplatelets, anticoagulants, and non-steroidal anti-inflammatory drugs, including ticagrelor (aOR 2.81), naproxen (aOR 1.87), and rivaroxaban (aOR 1.31), were strongly associated. These studies demonstrate the generalizability and transportability of the PharmWAS pharmacovigilance framework. With additional validation, PharmWAS could complement traditional passive surveillance systems to identify medications that unexpectedly provoke or prevent high-impact conditions. U.S. National Institute of Diabetes and Digestive and Kidney Diseases.

IJCM_245A: Beyond the Basics: Insights into Pharmacovigilance Literacy among Postgraduate Medical students: A Mixed-Methods study from central India.

Background: Pharmacovigilance ensures medical intervention safety by detecting, assessing, understanding, and preventing adverse drug effects or related issues. As the guardians of patient well-being, healthcare professionals, particularly postgraduate medical students, are integral contributors to the pharmacovigilance landscape. Understanding their knowledge, attitudes, and practices in this domain is essential for fostering a culture of drug safety and continuous improvement in healthcare delivery. The present study aspires to identify potential gaps in awareness, uncover barriers to active participation in pharmacovigilance activities, and, ultimately, offer insights that can inform targeted educational interventions. Objectives: To assess the knowledge levels of postgraduate medical students regarding pharmacovigilance, to examine their attitudes towards reporting adverse drug reactions, and explore the practical application of pharmacovigilance principles in their clinical practice. Additionally, the study aimed to identify potential barriers and facilitators influencing their engagement with pharmacovigilance activities. Methodology: This research adopted a mixed-method approach, combining quantitative and qualitative techniques to provide a comprehensive understanding of the subject matter. In Qualitative phase the focused group discussion has been undertaken followed by developing the questionnaire which after validation was used for quantitative data collection. The study population comprised postgraduate medical students from the tertiary care institute of central India. Data analysis involved thematic analysis for qualitative data and statistical techniques for quantitative data. Results: It was observed that the knowledge of the participants regarding ADR reporting and pharmacovigilance was poor. Conclusion: Various barriers regarding ADR reporting were identified, and appropriate interventions were suggested by the participants.

Strategic Partnerships in Pharmacovigilance: Business, Legal, and Regulatory Domains

Pharmaceutical development is a highly regulated industry through numerous worldwide guidance, laws, and regulations. Issues related to the safety of pharmaceutical products have been the most common cause of withdrawals from the market, as well as restrictions on distribution and limitations on labeling. Collaboration (hereafter referred to as partnership) between pharmaceutical companies in drug development has been recognized as critically significant to maximize the efficiency of drug development. In general, pharmaceutical companies might benefit from partnering in conducting pharmacovigilance (PV) activities, resulting in enhanced safety monitoring, improved clinical outcomes, and support of optimal benefit-risk assessment. However, some challenges exist. Differences between partners in strategy, culture, and processes can impact the harmonization of safety practices and decision-making processes, necessitating open communications and consensus-building to effectively address safety concerns. Both successful and unsuccessful partnership attempts within the pharmaceutical industry provide valuable business cases and lessons for the future. This paper sheds light on some of the critical aspects of PV in partnerships within the pharmaceutical industry. It addresses issues of the benefits and risks of partnerships, regulatory/legal expectations, and best practices for safety teams’ integration.

An Overview of Pharmacovigilance Practice and Management in Sub-Saharan African Countries

Most sub-Sahara African countries faced with prolonged resource deficiencies suffers specific constraints in establishing a functional and operationally-free pharmacovigilance systems platforms which should guide and in facilitate the generation of vital data to reinforce health information policies and practices. Despite the commendable efforts invested by the different stake holders within such countries to harmonize pharmacovigilance guidelines and regulations, lack of integration and the dependence on pharmacovigilance systems remain major constrains. Other identified difficulties are those associated with the problem of translating data reporting tools into multiple communicable languages, and the inadequacy of the healthcare experts who translates with the patient’s population, the pressure imposed by the short consultation time between a patient and a health practitioner. To add to this, there exist issues of community concern like the increasing use of herbal traditional products with anecdotal therapeutic evidence, low quality, self-medication practices, counterfeit and roadside drugs use, substandard medications that are readily accessible to the population. Some prolonged problems are associated with social and political instability, territorial conflicts, little or no access to drug utilization data, which makes it difficult to reliably estimate the true risks of medication use. Pharmacovigilance activities are still at its infancy due to poor and less trained health personnel, lack of budget allocation for health vigilance from the State financial attributions. In addition to the limited investment in pharmacovigilance activities, there is little collaboration between public health programmes and National Medicines Regulatory Authorities (NMRA), especially during mass drug administration for neglected tropical diseases and mass vaccinations. Frequent spontaneous report in SSA is low and this can hinder robust signal detection analyses. This paper attempts to identify the challenges of the practice of pharmacovigilance in sub-Saharan African countries and its implication in health vigilance in the community. In this paper, we review the specific challenges and areas of progress in pharmacovigilance in SSA.

Pharmacovigilance in Nigeria: Addressing challenges in ensuring drug safety and monitoring adverse effects

This paper examines the specific challenges faced by Nigeria in implementing pharmacovigilance measures to ensure drug safety and monitor adverse effects. Despite the critical importance of pharmacovigilance in safeguarding public health, Nigeria grapples with several obstacles in its implementation. Through a nuanced exploration of literature and regulatory frameworks, this study sheds light on the unique hurdles encountered in pharmacovigilance practices within the Nigerian context. Challenges in Nigeria's pharmacovigilance landscape include limited awareness and understanding of pharmacovigilance principles among healthcare professionals and consumers, resulting in underreporting of adverse drug reactions. Additionally, there is a lack of robust infrastructure and resources for pharmacovigilance activities, including inadequate funding, shortage of trained personnel, and deficient pharmacovigilance databases. Regulatory enforcement and oversight are also hindered by issues such as weak regulatory frameworks, fragmented reporting systems, and suboptimal collaboration among regulatory agencies. Furthermore, Nigeria's pharmacovigilance efforts are compounded by factors such as the proliferation of counterfeit and substandard medicines, informal drug markets, and cultural beliefs influencing healthcare-seeking behaviors. These challenges pose significant barriers to effective pharmacovigilance implementation and compromise patient safety and public health outcomes in Nigeria. Addressing these challenges requires a multifaceted approach encompassing regulatory reforms, capacity building initiatives, public awareness campaigns, and collaboration with international partners. Strengthening regulatory frameworks, enhancing healthcare professional training on pharmacovigilance, establishing robust reporting systems, and fostering partnerships between regulatory agencies, healthcare institutions, and pharmaceutical companies are essential steps toward improving pharmacovigilance practices in Nigeria. Through a thorough examination of the Nigerian context, this paper aims to raise awareness of the specific challenges hindering pharmacovigilance implementation in the country and stimulate dialogue on potential solutions to enhance drug safety and monitoring of adverse effects in Nigeria's healthcare system.

Automation in Pharmacovigilance

The term “pharmacovigilance,” first proposed in the1970s, has gradually gained traction to become one of the two common terms of art for the overall discipline, the other, older term being “drug safety.” “World Health Organization (WHO)” as “the science and activities relating to the detection, assessment, understanding and prevention of drug-related problems”. The information about suspect product is collected from healthcare providers and patients to detect and prevent abnormalities associated with it. Therefore, PV deals with adverse effects of drug, poly-pharmacy, paradoxical reactions, and severe adverse events. Automation in pharmacovigilance entails using cognitive technologies such as machine learning (ML) and advanced analytics to transform legacy data compilation processes and information gathering for regulatory approval. Automation technologies have strong potential to automate routine work and balance resource use across safety risk management and other pharmacovigilance activities. This article provides an overview of automation in pharmacovigilance.

Recording of suspected adverse drug reaction reporting in veterinary free-text clinical narratives.

To use text mining approaches to identify instances of suspected adverse drug reactions recorded in first opinion veterinary free-text clinical narratives, and to evaluate whether these were also reported to either the Veterinary Medicines Directorate or the relevant Marketing Authorisation holder in order to derive an estimate of the suspected adverse drug reaction (sADR) minimum under-reporting rate. To characterise sADR reports and explore whether particular features are associated with report submission. Two regular expressions were developed to identify mentions of "adverse drug reactions" and "side effects" in the free-text clinical narratives of electronic health records contained within the Small Animal Veterinary Surveillance Network database. Consultations containing a match for the developed regular expressions were manually reviewed for inclusion and further classified to determine the suspected product, seriousness and expectedness of the event, and an indication of whether the event had been reported. The associations between event characteristics and reporting were explored using Fisher's exact tests. A total of 10,565 records were manually reviewed from which 827 sADRs were identified. Approximately 90% of these sADRs were not recorded as reported. Suspected adverse drug reactions that were not considered "expected" were recorded as reported more frequently than "expected" sADRs. However, clinical severity did not appear to impact on whether there was a record of reporting. This is the first estimate of under reporting sADRs based on real world evidence from veterinary clinical records. The under-reporting rate implied by this study highlights that further interventions are required to improve reporting rate within the veterinary profession in order to support pharmacovigilance activities and improve drug safety.

Improving Drug Safety in Pediatric and Young Adult Patients with Hemato-Oncological Diseases: A Prospective Study of Active Pharmacovigilance.

The acquisition of relevant pediatric clinical safety data is essential to ensure tolerable drug therapies. Comparing the real number of Adverse Drug Reaction (ADR) reports in clinical practice with the literature, the idea of ADR underreporting emerges. An active pharmacovigilance observational prospective study was conducted to assess the safety of oncology pharmacological prescriptions in patients aged 0-24 years at Institute for Maternal and Child Health IRCCS Burlo Garofolo in Trieste and IRCCS CRO National Cancer Institute in Aviano (Italy) between January 2021 and October 2023. Prescriptions and ADRs were evaluated by a multidisciplinary team. A total of 1218 prescriptions for 38 patients were analyzed, and 190 ADRs of grade 3-5 were collected. As compared to historical data, we registered a significant increase (p < 0.001) in the number of ADRs. The risk of ADR was 3.4 times higher in the case of off-label prescriptions compared to on-label ones (OR 3.4; [1.47; 7.89]; p-value = 0.004). The risks of error and near-miss were reported for 6.3% and 18.2% of total prescriptions, respectively. Of the total of 133 interactions, 47 (35.3%) resulted in ADRs. This study shows the importance of pro-active pharmacovigilance to efficiently highlight ADRs, and the fundamental role of multidisciplinary teams (oncologist, pharmacist, pharmacologist, pediatrician, nurse) in improving patients' safety during therapy.

Current situation and issues regarding termination of risk management plans in Japan.

In Japan, drugs approved after the 2013 implementation of the risk management plan (RMP) have the opportunity to be evaluated for RMP termination. However, the guidelines for risk management following the termination of an RMP remain unclear. Drugs are evaluated for RMP termination at the timing of reexamination. Reexamination system is unique to Japan and initiated in 1979, verifies the approved efficacy and safety of a newly marketed drug based on the data from its actual use over a certain period. This study investigated drugs in Japan for which the RMP requirement was lifted upon reexamination and those for which it was not. We organized their characteristics and considered future issues. We identified drugs with RMPs and obtained information on RMP termination from the public website of the Pharmaceuticals and Medical Devices Agency (PMDA). The survey period spanned 10 years, from April 2013, when the RMP was implemented, to March 2023. During the survey period, 72 drugs with RMPs completed reexamination in Japan. The RMP requirement was lifted for 69 drugs (95.8%) and remained for three drugs (4.2%). Upon RMP termination, 16 out of 69 drugs (23.2%) had important potential risks not listed in the package insert, with malignant neoplasm being the most common. Eleven drugs (15.9%) had important missing information not listed in the package insert, with the most common being the impact on cardiovascular risk. Two drugs (2.9%) had ongoing additional pharmacovigilance activities, and 43 drugs (62.3%) had additional risk minimization activities. Upon reexamination completion, the RMP requirement was lifted for many drugs and remained for a few. Should safety concerns require continued attention following reexamination, we advocate for the continuation of the RMP, guided by more explicit rules. In light of the harmonization of RMP rules with those of other countries, there is a desire for enhanced drug safety management.

Exploring the community pharmacist's knowledge, attitude, and practices regarding adverse drug reactions and its reporting in the United Arab Emirates: a survey-based cross-sectional study.

Adverse drug reactions (ADRs) contribute significant clinical and economic burden to the country's healthcare system globally. Prompt reporting of ADRs by the community pharmacist is essential to the active pharmacovigilance program. This study assesses private community pharmacists' knowledge, attitude, and practice (KAP) about ADRs and reporting. A cross-sectional, qualitative study was performed using a pre-validated self-administered questionnaire. This self-administered questionnaire was conducted at community pharmacies between March and July 2022. The data collected were analyzed using the Mann-Whitney and Kruskal-Wallis tests to examine the differences in overall KAP scores with a subgroup of sociodemographic characteristics of the study participants. Logistic regression analysis was used to analyze the predictors of practice. In total, 156 fully completed questionnaires were collected by the community pharmacists. A positive association between the designation, qualification, and work experience with the total scores of the respondents was observed (p < 0.05). Among the predictors of ADR reporting practice, a significant association was observed with knowledge score (⩾6, p = 0.0219), designation (pharmacists, p = 0.0102), qualification (masters, p = 0.0002), and work experience (⩾11 years, p = 0.0184). Most community pharmacists had good knowledge and attitude but poor practice toward reporting ADRs. Uncertainty of how and where to report, lack of training, lack of reporting forms, and insufficient clinical knowledge were the practice-based barriers in the ADR reporting process. Though the study found sufficient understanding and favorable views on ADR reporting, participants reported poor practices and barriers to reporting ADR. Therefore, structured continuing professional development programs for community pharmacists are needed to overcome the barriers and enhance the practice of ADR reporting.