Reports Of Adverse Drug Reactions Research Articles

Development of a drug risk analysis and assessment system and its application in signal excavation and analysis of 263 cases of fluoroquinolone-induced adverse reactions.

Background: Adverse drug reaction (ADR) signal mining is essential for assessing drug safety. However, the currently available methods for this are rather cumbersome. Objective: We aimed to develop a drug risk analysis and assessment system using Java language and conduct pharmacovigilance data mining for fluoroquinolones at our hospital. Methods: We used ADR data reported by Shandong Provincial Third Hospital between July 2007 and August 2021. The signal detection methods included proportional reporting ratio (PRR), reporting odds ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN), Medicines and Healthcare products Regulatory Agency (MHRA). The BCPNN method was used as the reference standard for comparing the remaining three signal detection methods based on sensitivity, specificity, positive predictive value, negative predictive value, and Jorden index. Results: The hospital database contained a total of 2,621 ADR reports, among which 263 were attributed to fluoroquinolones. There were 391 fluoroquinolone-ADR pairs. Using the PRR, ROR, MHRA, and BCPNN method, we detected 13 signals, 13 signals, 10 signals, and 11 weak signals, respectively. After signal detection, levofloxacin and moxifloxacin were shown to induce high risk signals for mental and sleep disorders, with the signal intensity of moxifloxacin being the most significant. Compared with BCPNN, the PRR and ROR methods showed better sensitivity, whereas the MHRA method showed better specificity. Conclusion: We developed a drug risk analysis and assessment system that can help hospitals and other medical institutions to detect and analyse ADR signals in the self-reporting system database, and thus improve drug safety. Further, it indicates that the central nervous system damage caused by fluoroquinolones should be monitored closely, and thus provides a reference for the clinical application of these drugs.

Effectiveness and safety in the management of chronic inflammatory diseases with etanercept and infliximab biosimilars in Colombian patients

ObjectiveTo determine the effectiveness and safety of infliximab and etanercept biosimilar drugs in patients diagnosed with rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, and psoriasis in a specialized institution in Colombia, between 2015 and 2019. MethodsA retrospective study in patients treated with infliximab and etanercept biosimilar drugs treated in an institution specializing in the management of rheumatological diseases, to verify the clinimetric indicators of effectiveness and reports of adverse drug reactions. Clinical, sociodemographic, and pharmacological variables were identified over 5 years of follow-up. Results207 patients were identified with a mean age of 48.7±15.1 years, 61.4% were women. Of the patients, 58.0% (n=120) used infliximab and 42.0% (n=87) etanercept. It was found that 46 (22.2%) patients had adverse drug reactions. At the end of the observation period, 61.6% (n=72) of the patients with RA had achieved control of the disease (mild activity or remission), and 57.9% (n=117) had problems with access to and persistence with therapy. ConclusionIn a group of patients treated in Colombia, the biosimilars of infliximab and etanercept showed proportions of effectiveness and safety comparable to the reference drugs, but lack of adherence to treatment was quite common.

Clozapine-associated myocarditis in the World Health Organization's pharmacovigilance database: Focus on reports from various countries

IntroductionThe incidence of clozapine-associated myocarditis varies by country. These variations were explored in VigiBase, the World Health Organization's global database which has >25 million spontaneously reported adverse drug reaction (ADR) reports from 145 national drug agencies. MethodsOn January 15, 2021, a search of VigiBase since inception focused on myocarditis in clozapine patients. The 3572 individual reports were studied using the standard VigiBase logarithmic measure of disproportionality called information component (IC). The IC measures the disproportionality between the expected and the reported rates. After duplicates were eliminated there were 3274 different patients with myocarditis studied in logistic regression models. ResultsThe first case was published in 1980 but since 1993 the VigiBase clozapine-myocarditis IC has been significant; moreover, currently it is very strong (IC=6.0, IC005–IC995=5.9–6.1) and statistically significantly different from other antipsychotics. Of the 3274 different patients with myocarditis, 43.4% were non-serious cases, 51.8% were serious but non-fatal, and 4.8% were fatal. More than half (1621/3274) of the reports came from Australia, of which 69.2% were non-serious, 27.7% serious but non-fatal, and 3.1% fatal. Asian countries contributed only 41 cases. ConclusionsIn pharmacovigilance studies, confounding factors may explain statistical associations, but the strength and robustness of these results are compatible with the hypothesis that myocarditis is definitively associated with early clozapine treatment (84% [1309/1560] and 5% [82/1560] in the first and second months). Myocarditis reports from Australia are over-represented to a major degree. Asian countries may be underreporting myocarditis to their drug agencies.

Data mining for adverse drug reaction signals of daptomycin based on real-world data: a disproportionality analysis of the US Food and Drug Administration adverse event reporting system.

Previous reports on daptomycin's adverse drug reactions (ADRs) have been insufficient, often because of limited data. Pharmacovigilance risk signal detection is innovative and has been applied to the safety monitoring and reevaluation of drugs post-marketing. The study aimed to promote safe daptomycin prescribing by mining and evaluating the daptomycin ADR signals from the US Food and Drug Administration Adverse Event Reporting System (FAERS). A disproportionality analysis (reporting odds ratio ROR and proportional reporting ratio PRR) was utilized for FAERS data mining from the first quarter of 2004 to the second quarter of 2021 (the most recent quarterly data at the time of the study). Preferred Terms of ADR reports were categorized by System Organ Class (SOC) based on the Medical Dictionary for Regulatory Activities. This study retrieved 12,221 cases within the reporting period. A total of 140 repetitive signals were obtained by ROR and PRR, of which 53 new ADR signals were not recorded in the drug labels/datasheets. The top three ADR reports were"blood creatine phosphokinase elevation"(ROR, 56.66, 95% confidence interval (CI) 51.07-62.87, PRR 51.94), "eosinophilic pneumonia" (ROR 696.71, 95%CI 603.21-804.70, PRR 657.57), and "rhabdomyolysis" (ROR 22.85, 95%CI 19.94-26.18, PRR 21.83). The highest ROR of "antimicrobial susceptibility test resistant" was found at 9808.14. Reports of rare adverse events, such as "necrotizing fasciitis and compartment syndrome," have emerged. The significant SOCs were "Infections and Infestations" and "Investigations." New daptomycin ADR signals were detected. Clinicians should monitor these potential ADRs in patients receiving daptomycin.

Mobile apps for quick adverse drug reaction report: A scoping review.

Spontaneous notification systems are essential in a post-marketing safety context. However, using this method, only about 6% of all adverse drug reactions are notified. To overcome this sub-notification problem, new methods need to be developed to improve and facilitate reporting. In this sense, the use of digital media, mainly medical mobile apps, has been presented as a powerful tool, including in pharmacovigilance. We performed a scope review to identify the available apps used to report adverse drug reactions around the world to eventually identify which of them best fits the Portuguese pharmacovigilance system. The Joanna Briggs Institute guidelines were considered, and the framework proposed by Arksey and O'Malley was followed. All the articles that met the inclusion criteria were examined for this review. When the studies lacked in information about the app, Google was used to enhance the search for further information. A final number of five articles were included, revealing seven implemented mobile apps for adverse drug reaction report (Medwatcher, VigiBIP, Yellow Card, Bijwerking, Halmed, Med Safety, and ADR PvPi). These apps are implemented in the United States, France, United Kingdom, The Netherlands, Croatia, and India. Med Safety was originally designed for multi-region use and is implemented in 12 low and middle-income countries. Apps are easier and faster ways of reporting. The integration of such a tool in an individual care plan would allow to maintain a complete electronic health record at both individual and global level and could be eventually seen as an added value by both health professionals and patients. A country specific version of the WEB-RADR could be a solution for Portugal, in order to introduce an app to notify ADRs at the national level, due previous successful experiences in European countries.

Educate and Train Healthcare Professionals and Healthcare Profession Students and make Aware Public about Reporting Adverse Drug Reactions (ADRs)

Educate and Train Healthcare Professionals and Healthcare Profession Students and make Aware Public about Reporting Adverse Drug Reactions (ADRs)

Classification of patient characteristics associated with reported adverse drug events to neuraminidase inhibitors: an applicability study of latent class analysis in pharmacovigilance.

Signal detection in reports of spontaneous adverse drug reactions is useful in pharmacovigilance, but does not adequately consider potential confounding factors such as patient background information contained in the report data. Multiple indicators should be considered when generating safety hypotheses. The aim of this study was to evaluate whether latent class analysis (LCA) can complement conventional methods in pharmacovigilance. We conducted LCA of 2732 reports of adverse drug reactions involving four widely used anti-influenza neuraminidase inhibitors in the Japanese Adverse Drug Event Report (JADER) database covering April 2004 to June 2020. LCA classifies the target population into multiple clusters based on response probability. The same data was subjected to multivariate logistic regression using an adjusted reporting odds ratio. LCA grouped the target population into three classes. Cluster 1 (46.4%) contained patients who developed adverse events other than neuropsychiatric events; these events were specific to adult females. Cluster 2 (28.7%) contained patients who developed abnormal behavior; these events were specific to underage males. Cluster 3 (24.8%) contained patients who developed adverse neuropsychiatric events other than abnormal behavior, such as hallucinations and convulsion; these events were specific to minors. Logistic regression of adverse events for which a signal was detected identified factors similar to those found in LCA. LCA classified adverse events in JADER with similar incidence tendencies into the same cluster. The results included signals identified by conventional logistic regression, suggesting that LCA may be useful as a complementary tool for generating drug safety hypotheses.

Pharmacovigilance and Its Importance for Primary Health Care Professionals.

Pharmacovigilance is used to detect, assess, understand, and prevent the adverse effects of medications. The need for safety monitoring has evolved around unfortunate incidents in history, with deaths caused by anesthesia and congenital malformations from thalidomide use. Reports from adverse drug reactions (ADRs) are stored in a global database and can be used to evaluate the associations between various medications and associated ADRs. Clinicians play an important role in the recognition and reporting of ADRs to national pharmacovigilance centers (NPCs). The purpose of NPCs is to make the clinicians understand their functions, including the monitoring, investigation, and assessment of ADR reports, along with periodical benefit-risk assessments of medications via multiple sources. A case study on NPCs and the types of safety issues evaluated by them are provided to illustrate their role in medicine safety surveillance. ADR monitoring was also combined with vaccine safety surveillance approaches. Overall, this study will provide insights to clinicians on the importance of pharmacovigilance in maintaining patient safety with the proper use of medications.

Quality of Active versus Spontaneous Reporting of Adverse Drug Reactions in Pediatric Patients: Relevance for Pharmacovigilance and Knowledge in Pediatric Medical Care.

For drug safety in pediatric patients, knowledge about adverse drug reactions (ADRs) is essential to balance benefits and risks, especially because of the high incidence of off-label drug use. However, underreporting of ADRs is a serious problem, leading to a deficit in knowledge affecting clinical practice. The aim of this study is to find a method by which we can improve the quantity of ADR reporting while maintaining or improving the quality of the ADR reports. This was done in several steps. First, health care providers were educated to increase awareness of ADRs. Thereafter, a novel active supporting system was introduced, where reporting ADRs was simplified; if clinical physicians suspected an ADR, they only had to send the name or hospital number of the patient, the observed ADR, and the suspected drug to a supportive team. This team collects all information needed about the possible ADR from the patient’s medical records and hospital charts. With this information, the supportive team fills in the forms necessary for reporting ADRs to the nationwide pharmacovigilance centre Lareb. With this system, the quantity of ADR reports from both inpatients and outpatients rose dramatically. Subsequently, the quality of the obtained ADR reports was measured using the ClinDoc and vigiGrade systems. This study shows there is no loss of quality of the ADR reports in the active reporting system compared to spontaneous reporting systems. Based on the data of the present study, we suggest that an active reporting system has the potential to increase our knowledge about ADRs in pediatric patients.

Analysis of pharmacovigilance databases for spontaneous reports of adverse drug reactions related to substandard and falsified medical products: A descriptive study.

Introduction: The public health threat of substandard and falsified medicines has been well known in the last two decades, and several studies focusing on the identification of products affected and preventing consumption have been published. However, the number of these products reaching patients and causing health consequences and adverse drug reactions is not a well-researched area. Objectives: Our aim was to identify and describe the characteristics of cases that are related to adverse drug reactions potentially originating from counterfeit medication using publicly available pharmacovigilance data. Methods: A descriptive study was performed based on pharmacovigilance data retrieved from Individual Case Safety Reports (ICSRs) identified in the European Medicines Agency’s EudraVigilance and FDA Adverse Event Reporting System (FAERS) databases in April 2022 using selected MedDRA preferred terms: counterfeit product administered, product counterfeit, product label counterfeit, product packaging counterfeit, suspected counterfeit product, adulterated product, product tampering, and suspected product tampering. ICSRs were analyzed by age and gender, by year of reporting, region of origin, reporter’s profession, and severity of the outcome. The disproportionality method was used to calculate pharmacovigilance signal measures. Results: A total of 5,253 cases in the FAERS and 1,049 cases in the EudraVigilance database were identified, generally affecting middle-aged men with a mean age of 51.055 (±19.62) in the FAERS and 64.18% of the cases between 18 and 65 years, while the male to female ratios were 1.18 and 1.5. In the FAERS database, we identified 138 signals with 95% confidence interval including sildenafil (n = 314; PRR, 12.99; ROR, 13.04; RRR, 11.97), tadalafil (n = 200; PRR, 11.51; ROR, 11.55; RRR, 10.94), and oxycodone (n = 190; PRR, 2.47; ROR, 2.14; RRR, 2.47). While in the EV data 31, led by vardenafil (n = 16, PRR = 167.19; 101.71–274.84; 95% CI, RRR = 164.66; 100.17–270.66; 95% CI, ROR = 169.47; 103.09–278.60; 95% CI, p < 0.001), entecavir (n = 46, PRR = 161.26, RRR = 154.24, ROR = 163.32, p < 0.001), and tenofovir (n = 20, PRR = 142.10, RRR = 139.42, ROR = 143.74, p < 0.001). Conclusion: The application of pharmacovigilance datasets to identify potential counterfeit medicine ADRs can be a valuable tool in recognition of potential risk groups of consumers and the affected active pharmaceutical ingredients and products. However, the further development and standardization of ADR reporting, pharmacovigilance database analysis, and prospective and real-time collection of potential patients with health consequences are warranted in the future.

Publication ethics: Patient consent for publishing case reports of adverse drug reactions is important yet absent from several recent manuscripts

Case reports of adverse drug reactions (ADRs) constitute an important source of medication safety information. Detailed description of patients in such reports could potentially make subjects identifiable, thereby emphasizing the importance of consent for publication. The Committee on Publication Ethics and the International Committee of Medical Journal Editors recommend obtaining patient consent prior to publishing potentially identifiable patient information. However, this report shows absence of information regarding patient consent for publication from several recently-published ADR case reports. A sample of 100 most-recent ADR case reports with free full-text indexed in PubMed was qualitatively reviewed for information regarding publication consent and other ethical disclosures. Of the 100 most-recently-published ADR case reports, only 52 (52%) manuscripts clearly described obtaining patient consent for publication. Thirty-seven (37%) manuscripts made no mention of such consent or approval from an ethics committee. Eleven (11%) manuscripts contained ethical disclosures such as patient consent to undergo treatment and study approval from an institutional ethics committee, but without a clear statement regarding patient consent for publication. A significant number of recently-published ADR case reports do not clearly describe if patient consent for publication was obtained. This could be attributable to various factors, including lack of clarity in journals’ guidelines regarding publication consent for case reports and dilemma regarding what constitutes identifiable patient information. This report calls for diligence of all stakeholders involved in medical manuscript publishing, viz. authors, manuscript reviewers, editors, and journal publishers to ensure that information regarding patient consent for publication is properly disclosed in ADR case reports.

Disease-specific ADRs of TNF-α inhibitors as reported by patients with inflammatory rheumatic diseases: a registry-based prospective multicenter cohort study

ABSTRACT Background The extent to which adverse drug reactions (ADRs) of biologics differ per immune-mediated inflammatory disease (IMID), and the relevance of tailoring ADR information per IMID is not fully investigated. We aimed to compare patient-reported ADRs attributed to adalimumab and etanercept between different inflammatory rheumatic diseases (IRDs). Research design and methods ADR reports from IRD patients were extracted from the Dutch Biologic Monitor. ADR frequencies were compared using Fischer–Freeman–Halton exact test and the influence of covariates was assessed using binomial logistic regression. Results A total, of 729 participants were included, of which 354 participants reported 887 unique ADRs. ADR frequencies were not significantly different between the IRDs. Rheumatoid arthritis and ankylosing spondylitis including axial spondyloarthritis patients had an increased risk of ADRs related to ‘Respiratory, thoracic and mediastinal disorders’ and as compared to psoriatic arthritis patients. Etanercept use, combination therapy with methotrexate and/or corticosteroids, and age also influenced the risk of reporting specific ADRs. Conclusions There were no differences in frequencies and nature of patient-reported ADRs attributed to adalimumab and etanercept between different IRDs. However, more research is needed to align patients’ and health-care professionals’ perspectives to improve knowledge on disease-specific ADRs.

The Impact of Pharmacist-Led Medication Management Services on the Quality of Life and Adverse Drug Reaction Occurrence.

The aim of this research was to assess the impact of comprehensive medication management (CMM) services on patients’ health-related quality of life (HRQoL) and frequency of adverse drug reactions (ADRs) in older patients with cardiovascular diseases (CVDs). A prospective, pre- and post-intervention study with a one-year follow-up was conducted at the Health Care Centre Zagreb—Centre (HCZC). The Euro-Quality of Life Questionnaire 5 Dimensions 5 Levels (EQ-5D-5L) was used to measure the HRQoL at baseline (initial visit at the HCZC) and 12 months following CMM services. The ADRs collected at the initial assessment of the CMM services and throughout follow-up consultations were analyzed according to the occurrence mechanism, seriousness, expectedness and distribution of the Preferred Term according to the System Organ Class. Following the CMM intervention, 65 patients reported significant improvement in dimensions “self-care” (p = 0.011) and “usual activities” (p = 0.003), whereas no significant change was found in the “mobility” (p = 0.203), “pain/discomfort” (p = 0.173) and “anxiety/depression” (p = 0.083) dimensions and the self-rated VAS scale (p = 0.781). A total of 596 suspected ADR reports were found, the majority at patients’ initial assessment (67.3%), with a mean ± SD of 9.2 ± 16.9 per patient. The CMM services significantly reduced the rate of suspected ADRs, namely 2.7 ± 1.7 ADRs per patient at the initial assessment vs. 1.0 ± 1.5 ADRs per patient at the last consultation (p < 0.001). The obtained results indicate that CMM services may improve patients’ HRQoL. Additionally, as CMM services diminished the proportion of ADRs following 1-year patient follow-up, they may serve as a viable solution for safety management.

Benefits of a National Program for Adverse Drugs Reactions (ADRS) Surveillance in Diabetic Patients

Voluntary notification of suspected adverse drug reactions (ADR) is the most worldwide method to detect these events. Unfortunately, health professionals in Latin American countries have no “culture” to notify ADR. For this reason, the National Diabetes Program (NDP) in Paraguay decided to regularly contact their patients, in order to increase ADR detection. To evaluate the results of this experience, this study was performed.&#x0D; Methods: a descriptive, observational, cross-sectional study with an intervention phase was performed. A non-probabilistic sample of patients belonging to NDP was selected and compared with historical results of the program. The intervention activities consisted in a monthly contact of the patients by a member of the program. &#x0D; Results: 2,390 patients with type II diabetes were enrolled in the study and compared with the same number of patients belonging to the program but with classical follow-up. Concerning the adverse drug reactions, 146 reports were registered during the study period, which mean 6.1% of all patients enrolled, while in the same period, historically the ADR reports were 0.94%. 66.9% of these reports were performed by the patients while 42.1% were notified by health professional. Main ADRs reported were vomiting 28.8%, dizziness 28.4%, diarrhea 10.8%, hypoglycemia 10.2% or abdominal pain 6.5%. The antidiabetic drugs that presented the greatest suspicion of ADRs were metformin 45.31%, glimepiride 21.8%, glibenclamide 6.25% and insulin 3.13%.&#x0D; Conclusion: Periodical contact of patients covered by a National Diabetes program was able to increase 6 times the historically annual of report of pharmacovigilance adverse drug reactions.&#x0D; Keywords: pharmacovigilance, adverse drug reactions, reports, voluntary, active notification, program.

Attitude of Doctors and Nurses towards Adverse Drug Reaction Reporting at a University Teaching Hospital

Introduction: Spontaneous reporting of adverse drug reaction (ADR) is the main stay of pharmacovigilance. However the major limitation of this method is underreporting as it depends entirely on the participation of the health care professional. This study aimed to identify factors that discourage ADR reporting and possible ways to improve ADR reporting. Methods: This is a questionnaire based cross-sectional descriptive study employed at a tertiary level teaching hospital from December 2020 to March 2021 after approval from institutional review committee. All the doctors and nurses were included in the study and the data were collected using structured questionnaire. Results: Total numbers of participants were 283. Among them, 260(91.9 %) had encountered a patient/s with ADR and 119(45.6%) had documented ADR. However, there was no reporting to the pharmacovigilance centre/ unit of the hospital.Out of 283 participants, 123 (43.5%) agreed that the major discouraging factor to report ADR was unavailability of reporting form. Similarly decision to report ADR depended on new reaction to an existing product 217(76.7%) followed by seriousness of the reaction 213 (75.2%). The 245(86.7%) participants have recommended to conduct awareness among healthcare professional and 208(73.3%) to train healthcare professional to improve ADR reporting. Conclusion: Even though the large numbers of participants have encountered patient/s with ADR but documentation of ADR is less. Further, none have reported due to limited knowledge regarding“what, how and where to report ADR”? In addition to these, unavailability of ADR reporting form was the major discouraging factor to report ADR.

Multi-label classification of symptom terms from free-text bilingual adverse drug reaction reports using natural language processing

Allergic reactions to medication range from mild to severe or even life-threatening. Proper documentation of patient allergy information is critical for safe prescription, avoiding drug interactions, and reducing healthcare costs. Allergy information is regularly obtained during the medical interview, but is often poorly documented in electronic health records (EHRs). While many EHRs allow for structured adverse drug reaction (ADR) reporting, a free-text entry is still common. The resulting information is neither interoperable nor easily reusable for other applications, such as clinical decision support systems and prescription alerts. Current approaches require pharmacists to review and code ADRs documented by healthcare professionals. Recently, the effectiveness of machine algorithms in natural language processing (NLP) has been widely demonstrated. Our study aims to develop and evaluate different NLP algorithms that can encode unstructured ADRs stored in EHRs into institutional symptom terms. Our dataset consists of 79,712 pharmacist-reviewed drug allergy records. We evaluated three NLP techniques: Naive Bayes-Support Vector Machine (NB-SVM), Universal Language Model Fine-tuning (ULMFiT), and Bidirectional Encoder Representations from Transformers (BERT). We tested different general-domain pre-trained BERT models, including mBERT, XLM-RoBERTa, and WanchanBERTa, as well as our domain-specific AllergyRoBERTa, which was pre-trained from scratch on our corpus. Overall, BERT models had the highest performance. NB-SVM outperformed ULMFiT and BERT for several symptom terms that are not frequently coded. The ensemble model achieved an exact match ratio of 95.33%, a F1 score of 98.88%, and a mean average precision of 97.07% for the 36 most frequently coded symptom terms. The model was then further developed into a symptom term suggestion system and achieved a Krippendorff's alpha agreement coefficient of 0.7081 in prospective testing with pharmacists. Some degree of automation could both accelerate the availability of allergy information and reduce the efforts for human coding.

Detection and Reporting of Adverse Drug Reactions Related to Antibiotics in Primary Healthcare in Greece.

Detection of adverse drug reactions (ADRs) is a challenging matter for healthcare professionals who contribute significantly to the pharmacovigilance system through their participation inspontaneous reporting. The objective of this study was the detection and reporting of ADRs related to antibiotics in primary health care in the region of Peloponnese. A cross-sectional study was conducted in all national health system primary health units of the Peloponnese region in Greece. A self-administered questionnaire was distributed to a total of 404 physicians who provided services in these settings. Descriptive and multivariate statistical analysis was performed using the SPSS 25.0. Levels of significance were two-tailed and statistical significance was set at p =0.05. 306 out of 404 physicians responded to the questionnaire, giving a response rate of 75.8%. 81.6% of physicians stated that they rarely observe ADRs related to antibiotic administration during their practice, 49.8% rarely report them, and 33.7% never report them. Non-serious side effects (42.5%), physicians' workload (24.1%), and the lack of knowledge about the reporting obligation (20.6%) have been declared as the main reasons of non - reporting. In addition, physicians with ≤10 years of clinical practice rarely reported that they experienced ADRs after antibiotics' administration compared to those with more work experience and specialized physicians (p= 0.001). ADRs reporting rates among physicians in primary healthcare are low. Changes in physicians' attitudes are vital and can be achieved through consistent and continuous training programs as well as the inclusion of ADRs and pharmacovigilance themes into the tertiary education curricula.

First reports of adverse drug reactions and drug interactions

First reports of adverse drug reactions and drug interactions

Evaluation of spontaneous reports in the pharmacovigilance system

The purpose of the study: to analyze the characteristics of spontaneous reports (SR) of adverse drug reactions (ADRs), as well as to assess their correlation with patients’ individual characteristics (gender, age) and drugs, on the example of the data from the Rostov Region.

The effect of clinical pharmacists’ intervention in adverse drug reaction reporting: a retrospective analysis with a 9-year interrupted time series

BackgroundIn China, 85.4% of adverse drug reactions (ADRs) are spontaneously reported by healthcare facilities. As a result, many ADRs are not reported due to lack of mandatory reporting requirements. As healthcare professionals, clinical pharmacists (CPhs) serve as a bridge between clinical work and medication and ensure rational drug use. In China, A team of CPhs implemented an intervention for ADRs reporting, with the goal of improving the number of ADRs reports, the number of unreported ADRs, and the standardized reporting rate.MethodsOn June 01, 2015, a team of CPhs implemented an intervention for ADRs reporting at a Grade A, Class 3 hospital in China. The drug review catalogue (DRC) was used to screen physician orders for having visible symptoms of ADRs across departments, pooled the ADRs, and submitted them to the Center for Advanced Drug Monitoring (CNCAM). We retrospectively analysed the effect of a CPhs ADRs reporting intervention on the number of clinical ADRs reports, the number of unreported ADRs, and the standardized reporting rate over a 9-year period by interrupted time series (ITS). The method was implemented at the hospital on June 1, 2015, and a segmented regression model was used to analyse the data from January 1, 2010, to December 31, 2019.ResultsAfter the CPhs ADRs reporting intervention, the number of inpatient ADRs reports submitted to the CNCAM immediately increased by approximately 63 (62.658, P < 0.01) and then decreased by approximately 1 (0.701, P = 0.000151 < 0.01) per month afterward; the number of unreported ADRs was immediately reduced by approximately 44 (44.091, P < 0.01) and remained largely unchanged over time (P > 0.05); the standardized ADRs reporting rate per month immediately increased by 63.634% (P < 0.01) and remained largely unchanged over time (P > 0.05).ConclusionThe CPhs ADRs reporting intervention had an immediate effect on improving ADRs reporting, which highlights the severity of ADRs underreporting in Chinese hospitals. The method is practical and should be used more widely in clinical practice. For example, the method can adjust and establish a DRC catalog that meets the actual situation of the implementing hospital based on the hospital's drug use habits and has the characteristics of good adaptability. However, it does have some limitations; for example, it may be difficult to detect early ADRs without visible symptoms.