Reports Of Adverse Drug Reactions Research Articles

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

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

ASSESSMENT OF PHARMACOVIGILANCE SYSTEM IN INDONESIA ACCORDING TO WHO PHARMACOVIGILANCE INDICATORS: CHALLENGES AND POSSIBLE SOLUTIONS

Due to the potential of Indonesia as a market and a huge number of emerging new products, a comprehensive pharmacovigilance evaluation is critical in overcoming challenges and assure product safety. This article evaluates the current pharmacovigilance establishment in Indonesia in accordance with indicators stated in the manual published by WHO to identify actual challenges and solution. Evidence of compliance with each indicator was based on data published by the Indonesian national agency of drug and food control that can be accessed on the official website. Furthermore, the collected data were categorized and summarized in tables. From the table, evidence of compliance for indicators CST6, CP6-7, and CO3-8 cannot be found on any official website. These indicators are related to a system for reporting therapeutic ineffectiveness and suspected medication errors, the cost and the number of medicine-related hospital admissions and medicine-related deaths, and low human resources and report numbers. Major cause of the issues, which is reflected in the low number of annualy taken actions, is the low number of reports of Adverse Drug Reactions (ADR) which are highly dependent on the Healthcare Professionals’ (HCPs) and industries’ pharmacovigilance competency and system. Improving HCP’s competency and procurement of resources necessary to arrange the required system are considered as effective solutions for attaining a comprehensive pharmacovigilance system. Keywords: Assessment, national agency of drug and food control, pharmacovigilance, WHO Indicators

Evaluation of Knowledge, Attitudes, and Practices about Pharmacovigilance among Community Pharmacists in Qassim, Saudi Arabia.

Pharmacovigilance (PV) is an essential activity to detect adverse drug reactions (ADRs) and ensure patient safety. Hence, we aimed to evaluate knowledge, attitudes, and practices (KAP) regarding PV among community pharmacists in Qassim, Saudi Arabia. A cross-sectional study was conducted by using a validated questionnaire after obtaining ethical approval from the Deanship of Scientific Research, Qassim University. The sample size was calculated based on the total number of pharmacists in the Qassim area by using Raosoft, Inc. Statistical Package for the Social Sciences version 20 was used for data entry and analysis. Ordinal logistic regression was performed to identify the predictors of KAP. A p-value of <0.05 was considered statistically significant. A total of 209 community pharmacists participated in the study; 62.9% of them defined the PV correctly, and 59% of them defined ADRs correctly. However, only 17.2% knew where to report ADRs. Interestingly, the majority of participants (92.9%) reported that it is necessary to report ADRs, and 73.8% of them were willing to report ADRs. A total of 53.8% of the participants identified ADRs during their careers; however, only 21.9% reported ADRs. Barriers discourage ADR reporting; the majority of the participants (85.6%) do not know how to report ADRs. Community pharmacists who participated in the study were knowledgeable about PV, and their attitude towards reporting ADRs was highly positive. However, the number of reported ADRs was low because of the lack of knowledge on how and where to report ADRs. Continuous education and motivation about ADRs reporting and PV are warranted among community pharmacists for the rational use of medications.

Is PEGylation of Drugs Associated with Hypersensitivity Reactions? An Analysis of the Italian National Spontaneous Adverse Drug Reaction Reporting System.

Evidence highlights the allergenic potential of PEGylated drugs because of the production of anti-polyethylene glycol immunoglobulins. We investigated the risk of hypersensitivity reactions of PEGylated drugs using the Italian spontaneous adverse drug reaction reporting system database. We selected adverse drug reaction reports attributed to medicinal products containing PEGylated active substances and/or PEGylated liposomes from the Italian Spontaneous Reporting System in the period between its inception and March 2021. As comparators, we extracted adverse drug reaction reports of medicinal products containing the same non-PEGylated active substances and/or non-PEGylated liposomes (or compounds belonging to the same mechanistic class). A descriptive analysis of reports of hypersensitivity reactions was performed. Reporting rates and time to onset of hypersensitivity reactions were also calculated in the period between January 2009 and March 2021. As a measure of disproportionality, we calculated the reporting odds ratio. Overall, 3865 adverse drug reaction reports were related to PEGylated medicinal products and 11,961 to their non-PEGylated comparators. Around two-thirds of patients were female and reports mostly concerned patients aged between 46 and 64 years. The frequency of hypersensitivity reactions reporting was higher among PEGylated versus non-PEGylated medicinal products (11.7% vs 9.4%, p < 0.0001). The hypersensitivity reaction reporting rates were higher for PEGylated medicinal products versus non-PEGylated medicinal products, with reporting rate ratios that ranged from 1.4 (95% confidence interval 0.8-2.5) for pegfilgrastim versus filgrastim to 20.0 (95% confidence interval 2.8-143.5) for peginterferon alpha-2a versus interferon alpha-2a. The median time to onset of hypersensitivity reactions was 10 days (interquartile range: 0-61) for PEGylated medicinal products, and 36 days (interquartile range: 3-216) for non-PEGylated comparators. Statistically significant reporting odds ratios were observed when comparing the reporting of hypersensitivity reactions for PEGylated versus non-PEGylated medicinal products (reporting odds ratio: 1.3; 95% confidence interval 1.1-1.4). However, when using all other drugs as comparators, the disproportionality analysis showed no association with hypersensitivity reactions for PEGylated nor non-PEGylated medicinal products, thus suggesting that many other triggers of drug-induced hypersensitivity reactions play a major role. The findings of this analysis of the Italian spontaneous adverse drug reaction database suggest a potential involvement for PEGylation in triggering drug-related hypersensitivity reactions, especially clinically relevant reactions. However, when comparing both PEGylated and non-PEGylated drugs under study to all other drugs no disproportionate reporting of hypersensitivity reactions was observed, probably due to a masking effect owing to the presence in the same database of other medicinal products increasing the threshold required to highlight a safety signal when the entire database is used as a reference.

Association of NSAID hypersensitivity with opioid prescribing following total joint arthroplasty

Nonsteroidal anti-inflammatory drugs (NSAIDs) are indicated for post-operative pain management, but medication use may be precluded by report of adverse drug reactions (ADRs). The impact of NSAID allergy labeling on opioid prescribing following total joint arthroplasty is unknown.

Impact of Educational Intervention on the Knowledge, Attitude, and Practice of Pharmacovigilance Among Nurses at a Tertiary Care Public Hospital.

Nursing students and employees remain the first point of contact in case a patient develops an adverse drug reaction in hospital settings. Thus, it is important for nurses to understand the importance of pharmacovigilance activity and implement the same in their practice. They can also contribute to drug safety by reducing medication errors and adverse drug reaction reporting. After ethics approval, an observational questionnaire-based study was conducted in 2017 that involved nursing students and nursing employees (N=390) to assess their baseline knowledge, attitude, and practice toward pharmacovigilance. Participants who consented were enrolled and a pre-training survey was conducted. Pharmacovigilance sensitization/ training sessions were conducted in the same year after getting their baseline data. Three years later in 2021, the same questionnaire was distributed to a subset of nursing students and employees (N=299) to analyze any change in their knowledge, attitude, and practice towards the pharmacovigilance activity as a posttest. Pre and post sensitization session questionnaire-based survey data was analyzed to confirm the long-term impact of conducting such pharmacovigilance awareness training. The nurses' overall performance before and after training in each of the domains of knowledge, attitude and practice were 17.53%, 72.86%, 39.69% in the pretest group, respectively, and post test scores were 30.77%, OR-3.04, p=0.0 (Knowledge), 85.92%, OR-0.14, p=0.0 (Attitude) and 37.21%, OR-0.08, p=0.08 (Practice) in the corresponding domain. Overall, there was a declining trend in the practice domain of the nurses response between the pre-test and post intervention groups however this decline was not statistically significant (p=0.08). Pharmacovigilance awareness training and sensitization programs had an impact on the knowledge and attitude of nurses but there is a need to ensure that it is implemented in clinical practice.

Characteristics of paediatric adverse drug reaction reports in Malaysia

During clinical trials, special populations such as children, pregnant women and elderly are excluded, creating lack of information on safety profile of medicines in these population. The lack of reliable efficacy and safety data often leads to under- or over-dosing in paediatric age groups which make them susceptible to adverse drug reactions (ADRs). This study was aimed to investigate the characteristics of ADR reports and serious ADRs among paediatric population in Malaysia. Descriptive analyses were undertaken for demographic characteristics and severity of the ADRs. Binary logistic regression was performed to identify association between selected variables and ADRs. A total of 3410 paediatric case reports for 6769 ADRs were reported within the 5-year period. Children aged one to 12 years old were the most frequently reported to experience ADRs (n=5488, 81%). Male gender exceeds more than half of the ADR reports (n=3812, 56.3%) and Malay race has the highest ADR reports (n=4780, 72%). Majority of the ADR reports were not serious (n=6285, 93%). Anti-infective medicines contributed most of the ADR reports (n=6024, 75%). The most common ADRs were from general disorders and administration site conditions (n=2879, 43%). A binary logistic regression showed male gender were more likely to experience nervous and respiratory system disorder ADRs (p &lt; 0.05). Surveillance of medicines marketed for use in children must be strengthened to prevent severe life-threatening ADRs. Effective support decision tool for prescribing in paediatric population with an integrated pharmacovigilance monitoring will support continuous safety monitoring for all marketed medicines.

First reports of adverse drug reactions

First reports of adverse drug reactions

The completeness of adverse drug reaction reports in South Africa: An analysis in VigiBase®.

Spontaneous reporting is regarded as a cornerstone of pharmacovigilance (PV) but presents many limitations, including varying quality and completeness of information, which is essential for causality assessment. This study aimed to evaluate the completeness of adverse drug reaction (ADR) reports in South Africa based on the vigiGrade completeness score. The South African Health Products Regulatory Authority (SAHPRA). A cross-sectional, descriptive study of all reports received by SAHPRA and submitted to VigiBase® in 2017 was conducted. A report with a vigiGrade score 0.8 is considered well-documented. The mean completeness score for the 8438 reports received was 0.456 (s.d. = 0.221). Only 11.3% of reports had a completeness score 0.8. The completeness of reports submitted by consumers professionals did not significantly differ from reports by physicians, pharmacists or other healthcare professionals (d ≤ 0.2). Reports of reactions that resulted in death (M = 0.572, s.e. = 0.007), disability (M = 0.491, s.e. 0.033) or were life threatening (M = 0.474, s.e. = 0.013) had a medium to large practically significant effect (0.5 ≥ d ≤ 0.8) on the completeness score compared with reports of congenital anomaly (M = 0.348, s.e. = 0.089). The completeness of reports submitted by consumers is comparable to those submitted by healthcare professionals. The completeness of reports was low and multiple measures to improve reporting are recommended.Contribution: This study describes the completeness of ADR reports in South Africa and the results can be used to improve training.

Reporting, Monitoring, and Handling of Adverse Drug Reactions in Australia: Scoping Review.

Adverse drug reactions (ADRs) are unintended consequences of medication use and may result in hospitalizations or deaths. Timely reporting of ADRs to regulators is essential for drug monitoring, research, and maintaining patient safety, but it has not been standardized in Australia. We sought to explore the ways that ADRs are monitored or reported in Australia. We reviewed how consumers and health care professionals participate in ADR monitoring and reporting. The Arksey and O'Malley framework provided a methodology to sort the data according to key themes and issues. Web of Science, Scopus, Embase, PubMed, CINAHL, and Computer & Applied Sciences Complete databases were used to extract articles published from 2010 to 2021. Two reviewers screened the papers for eligibility, extracted key data, and provided descriptive analysis of the data. Seven articles met the inclusion criteria. The Adverse Medicine Events Line (telephone reporting service) was introduced in 2003 to support consumer reporting of ADRs; however, only 10.4% of consumers were aware of ADR reporting schemes. Consumers who experience side effects were more likely to report ADRs to their doctors or pharmacists than to the drug manufacturer. The documentation of ADR reports in hospital electronic health records showed that nurses and pharmacists were significantly less likely than doctors to omit the description of the drug reaction, and pharmacists were significantly more likely to enter the correct classification of the drug reaction than doctors. Review and analysis of all ADR reports submitted to the Therapeutic Goods Administration highlighted a decline in physician contribution from 28% of ADR reporting in 2003 to 4% in 2016; however, within this same time period, hospital and community pharmacists were a major source of ADR reporting (ie, 16%). In 2014, there was an increase in ADR reporting by community pharmacists following the introduction of the GuildLink ADR web-based reporting system; however, a year later, the reporting levels dropped. In 2018, the Therapeutic Goods Administration introduced a black triangle scheme on the packaging of newly approved medicines, to remind and encourage ADR reporting on new medicines, but this was only marginally successful at increasing the quantity of ADR reports. Despite the existence of national and international guidelines for ADR reporting and management, there is substantial interinstitutional variability in the standards of ADR reporting among individual health care facilities. There is room for increased ADR reporting rates among consumers and health care professionals. A thorough assessment of the barriers and enablers to ADR reporting at the primary health care institutional levels is essential. Interventions to increase ADR reporting, for example, the black triangle scheme (alert or awareness) or GuildLink (digital health), have only had marginal effects and may benefit from further improvement revisions and awareness programs.

Pharmacovigilance Activities in Maulana Azad Medical College and Associated Hospitals

Introduction: Pharmacovigilance plays an important role in patient safety and rationalizing the use of medicines. It helps in identifying the frequency of adverse drug reactions (ADRs), their causes, and the associated risk factors. Pharmacovigilance activities are facilitated through adverse drug reactions monitoring centers (AMCs) in most of the institutions. Aim: The objective of this paper is to provide an overview to the health care professionals regarding ADRs reported from the associated hospitals of Maulana Azad Medical College (MAMC) and the pharmacovigilance activities undertaken. Observations: Maulana Azad Medical College, Department of Pharmacology was recognized as an AMC in 2014 under the Pharmacovigilance Program of India (PvPI). The AMC established a way for reporting ADRs both by spontaneously and through active monitoring of ADRs from different wards. The causality assessment of all ADR reports collected is done. The program was informed by a college pharmacovigilance committee, emails, and by putting posters in the hospital nursing stations. Fourteen training workshops for doctors and pharmacists and two training workshops exclusively for nurses have been conducted so far on pharmacovigilance. In 2017, a program to sensitize doctors working in the Delhi government hospital was started. A total of 854 healthcare workers have been sensitized. The center has reported a total of 2572 ADRs to the National Coordination Centre (NCC) at Indian Pharmacopoeia Commission until December 2021. ADRs reported were highest in the age group of 20 to 59 years. Most of the reports were from the department of T.B. and Chest (n = 589, 23.8%). The most common class of medicines implicated in causing ADRs was antimicrobials (n = 1100, 44%). Among the ADRs reported, the majority were mild (n = 1451, 81.1%) with 346 (18.8%) reported as serious. Conclusion: A system for reporting ADRs on campus has been established. The pattern of ADRs reported to this ADR monitoring center is comparable to the national and global data. Hospital-based ADR monitoring and reporting programs are very crucial to identify and quantify the risks associated with the use of medicines. The pharmacovigilance program at MAMC is a commitment and a small step towards patient safety.

A Review of In Silico and Chemoinformatic Models in Pharmacovigilance Studies.

Background: Following an increase in the reports of adverse drug reactions, it is pertinent that in silico and cheminformatic models are adopted as most pharmacovigilance activities to enhance drug safety during drug utilization. Objectives: The study therefore assessed in silico and chemoinformatic models in literature that would help in the furtherance of pharmacovigilance activities. Methods Extraction of data was carried out based on pre-defined inclusion criteria and such data were evaluated for bias. Novel method based on Drug Interaction Profile Fingerprints (DIPFs) with successful application to Drug-Drug Interaction (DDI) detection was the approach adopted. Results: The main database search identified 56,675 articles, among which 143 articles were excluded based on titles and duplicates. Out of those that were included, 18 articles had relevance to the topic being studied. Out of those excluded, 95 articles had full-text incompletion and 48 articles were identified in the grey literature. The reference lists for the included articles identified 5 additional articles. Relevant articles published after completing the search were also included. Ten different articles or sets of data were described as novel methodologies using Quantitative- Structure-Activity Research (QSAR) to predict DDI, and Stevens-Johnson Syndrome (SJS). Databases were also identified. Conclusion: Findings in this study have shown that some researchers are working to enhance and develop easier models for pharmacovigilance studies. Therefore keen interest in in silico and chemoinformatic models should be adopted to enhance pharmacovigilance activities.

Incidence of urticaria, angioedema, and type I hypersensitivity reactions associated with fibrinolytic agents in Thailand using the database of the health product vigilance center.

Besides hemorrhage, allergic reactions have also been observed in several clinical trials of fibrinolytic agents. These reactions might negatively affect patient outcomes, especially life-threatening type I hypersensitivity reactions such as anaphylaxis. However, there are limited data on the incidence of these reactions. The aim of study was to analyze the incidence of urticaria, angioedema, and type I hypersensitivity reactions from fibrinolytic agents for various indications. A retrospective analysis of data from the Thai Vigibase database was conducted. All reports of adverse drug reactions from fibrinolytic agents from 1984 to 2017 were identified using the World Health Organization adverse reaction terminology. The proportion of each suspected adverse drug reaction and the cumulative incidence were calculated. A total of 284 reports were identified in the Thai Vigibase database. The overall incidence of urticaria, angioedema, and type I hypersensitivity reactions for the streptokinase group was 52.64/10,000 persons, with individual incidence rates of 9.64/10,000 persons for urticaria, 8.90/10,000 persons for angioedema, and 34.11/10,000 persons for type I hypersensitivity reactions. In the alteplase group, the overall incidence for all suspected reactions was 18.90/10,000 persons, with individual incidence rates of 3.29/10,000 persons for urticaria, 5.75/10,000 persons for angioedema, and 9.86/10,000 persons for type I hypersensitivity reactions. Type I hypersensitivity reactions were the most common allergic reactions from fibrinolytic agents. It is necessary to take these reactions into consideration when using fibrinolytic therapy.

PHARMACOVIGILANCE IN SERBIA: A TEN-YEAR PHARMACOEPIDEMIOLOGIC ANALYSIS.

Pharmacovigilance as a science and group of activities related to detection, collection, analysis, understanding and prevention of adverse drug reactions (ADRs) is an essential activity in the regulatory system of drugs of any country. Defining increased patient safety as the main purpose of ADR reporting, a well-designed national pharmacovigilance system achieves its ultimate goal, i.e., protection of public health. In organizational and technical terms, the Republic of Serbia has a well-developed system of pharmacovigilance, created on the basis of a proven reliable system of the former SFR Yugoslavia, and carried out by the National Agency for Medicines and Medical Devices of Serbia (ALIMS), which conducts all organized activities aimed at strengthening the national system of ADR monitoring and reporting. Unlike the neighboring Croatia and Montenegro with similar pharmacovigilance systems, Serbia has only recently approached the WHO standard of 200 reports per million inhabitants despite a significant increase of 180 ADR reports per million inhabitants in 2019 (1251 in total). Considering this, our study aimed to provide a critical insight into the practice of pharmacovigilance in Serbia by pharmacoepidemiologic analysis of a ten-year period of ADR monitoring and reporting activities.

Assessing adverse drug reaction reports for antidiabetic medications approved by the food and drug administration between 2012 and 2017: a pharmacovigilance study.

Between 2012 and 2017, the U.S. Food and Drug Administration (FDA) approved 10 antidiabetic indicated therapies. Due to the limited literature on voluntarily reported safety outcomes for recently approved antidiabetic drugs, this study investigated adverse drug reactions (ADRs) reported in the FDA Adverse Event Reporting System (FAERS). A disproportionality analysis of spontaneously reported ADRs was conducted. FAERS reports from January 1, 2012 to March 31, 2022 were compiled, allowing a 5-year buffer following drug approval in 2017. Reporting odds ratios were calculated for the top 10 ADRs, comparing new diabetic agents to the other approved drugs in their therapeutic class. 127,525 reports were identified for newly approved antidiabetic medications listed as the primary suspect (PS). For sodium-glucose co-transporter-2 (SGLT-2) inhibitors, the odds of blood glucose increased, nausea, and dizziness being reported was greater for empagliflozin. Dapagliflozin was associated with greater reports of weight decreased. Canagliflozin was found to have a disproportionally higher number of reports for diabetic ketoacidosis, toe amputation, acute kidney injury, fungal infections, and osteomyelitis. Assessing glucagon-like peptide-1 (GLP-1) receptor agonists, dulaglutide and semaglutide were associated with greater reports of gastrointestinal adverse drug reactions. Exenatide was disproportionally associated with injection site reactions and pancreatic carcinoma reports. Pharmacovigilance studies utilizing a large publicly available dataset allow an essential opportunity to evaluate the safety profile of antidiabetic drugs utilized in clinical practice. Additional research is needed to evaluate these reported safety concerns for recently approved antidiabetic medications to determine causality.

First results from the lessons learnt from the deployment of the Med Safety App for reporting adverse drug reactions in Ghana.

The use of mobile phone technology for reporting adverse drug reactions (ADRs) in pharmacovigilance is relatively new.The objective of the study was to explore challenges and facilitators for the use of the Med Safety App for reporting ADRs in Ghana. A comparative evaluation of ADR reports received through the app and the standard paper-based form was also conducted. This was a cross-sectional study with a purposive sampling technique. The study population was persons who had downloaded the Med Safety App launched in Ghana 18 months before the study. Of the 350 participants, 121 provided answers to the questionnaire sent as a Google form, representing a response rate of 34.6%.Ninety-five (78.5%) of the participants were healthcare professionals, and the remaining were patients. Seventy-five (64.7%) of the participants were using the app after initial installation because they thought it had helpful features. However, only 33 (27.3%) participants used the app to report ADRs, and of these, seven (21.2%) participants indicated that they would continue to use the app because it was easier than the other means of reporting ADRs. Most of the respondents, 109 (94%), indicated that they would recommend the app to someone else. There were some differences between the reports received through the app and between the paper-based Council for International Organizations of Medical Sciences (CIOMS) 1 form and the app, which warrant further exploration. Most participants indicated that the app is a useful tool and easy to use, and they were satisfied with the features of the app. Given that only just under one-third of participants had used the app to report ADRs, more time and training may be required to fully evaluate the feasibility of the use of the app going forward. The findings will help improve introduction of the app in other countries.

Knowledge, Attitude and Practice of Adverse Drug Reactions (ADRS) Reporting in Nursing Staffs of Tertiary Care Hospital

Background Adverse Drug Reactions (ADRs) are adverse consequences of drug therapy and are a major cause of morbidity and mortality. Approximately 2.9-5.6% of all hospital admissions are due to ADRs and up to 35% of hospitalized patients experience ADRs during their hospital stay. Therefore, the study assesses nurses’ knowledge, attitudes and practices (KAP) for monitoring and reporting spontaneous adverse drug reactions (ADRs). Methods In this observational study, 155 professional nurses with Proficiency Certificate Level (PCL), Bachelor Nurses and Masters working in various hospitals and academic institutes in Janakpur Municipality were selected to complete 19 pre-validated questionnaires on knowledge, attitudes and practice of ADR monitoring and reporting’ response. The data were converted by a predetermined scoring method and subjected to statistical analysis. Results Most participants from PCL Nursing (52.25%), participants from Bachelor Nursing (35.48%) and the fewest participants from Master Nursing (12.25%) were between 26 and 35 years old. Regarding ADRs knowledge, the majority of the Master Nurses (86.18%) answered the question correctly. ADR that reported regularly, most certificate nurses disagreed (33.3%) and more certificate nurses were neutral (38.2%) and some certificate nurses were agreed (28.3%). Most master nurses (63.1%) had patients with ADRs, but bachelor nurses (52.7%) and certificate nurses (64.2%) had not experienced any patients with ADRs in the past year. Master nurses (78.9%) were aware of the response to ADRs reporting and monitoring, but most certificate nurses (83.9%) and bachelor nurses (65.5%) were unaware of the ADRs reporting and monitoring response. Conclusion We conclude that KAP of ADRs in nurses is not sufficient especially in certificate and bachelor nurses. But master level nurses responded well. This is due to their knowledge, attitude and practices on ADRs reporting and monitoring.

Analysis of the activity of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in the field of clinical trials, registration of medicinal products and monitoring of adverse drug reactions in 2017-2021

The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (ORMP) is the state registration authority that grants the marketing authorization for medicinal products on the pharmaceutical market in Poland. ORMP is also involved in approving and controlling clinical trials and in safety of pharmacotherapy (pharmacovigilance) by collecting and analysing reports of adverse drug reactions (ADR). The aim of the study was to review the activity of ORMP in the field of 3 basic competences of this authority: clinical trials, registration of medicinal products and pharmacovigilance in the last 5 years. The evaluation was carried out by the method of document analysis on the basis of data contained in annual bulletins of medicinal products for the years 2017-2021 published by ORMP. In 2017-2021, an increasing trend of clinical trials submitted to ORMP was observed, and they were mainly in phase II and III. Most of the medicinal products introduced to the Polish pharmaceutical market in 2017-2021 were drugs prescribed by a doctor, registered in a decentralized procedure, used in diseases of the nervous and cardiovascular systems and in the treatment of cancer. A relatively low activity of ORMP in monitoring the safety of pharmacotherapy was demonstrated, which was a consequence of low activity of medical staff in the spontaneous ADR reporting. The conducted analysis confirmed the key role of ORMP in surveillance of clinical trials and introducing new medicinal products to the pharmaceutical market in Poland but also indicated the need for increased activity in the area of pharmacovigilance.

Safety Profile of Molnupiravir in the Treatment of COVID-19: A Descriptive Study Based on FAERS Data

Concerns have been raised about the actual benefit and safety of molnupiravir, a new antiviral treatment for coronavirus disease 2019 (COVID-19). In order to provide additional evidence to support its use, we aimed to evaluate the real safety profile based on post-marketing pharmacovigilance data. Molnupiravir safety data were captured from the FDA Adverse Event Reporting System (FAERS). We performed a descriptive analysis of the baseline demographic characteristics of patients who experienced at least one adverse drug reaction (ADRs) related to molnupiravir, and then evaluated those most frequently reported. As of 31 March 2022, 612 reports of ADRs related to molnupiravir were submitted to the FDA, 301 (49.18%) were related to females and 281 (45.92%) to males. Most reports (524; 85.62%) were submitted by healthcare professionals and 345 (56.37%) concerned serious outcomes. The most common reported ADRs were diarrhoea (57; 4.51%), rash (36; 2.85), nausea (29; 2.30%), and COVID-19 pneumonia (22; 1.74%). The most frequent adverse reactions reported with molnupiravir in the U.S. post-marketing experience are consistent with the safety evaluation of the antiviral medicine. Even if no evident safety concerns emerged, an unexpectedly high rate of serious adverse reactions together with a few cases of potential new adverse reactions occurred.

Patient involvement in pharmacovigilance: determinants and evolution of reporting from 2011 to 2020 in France

IntroductionBecause patients and patient organizations want to strengthen their role in the care pathway and drug evaluation and in order to improve pharmacovigilance activities, European competent authorities implemented regulations to allow direct reporting of adverse drug reactions related to medicinal products by patients in 2012.ObjectivesTo describe evolution and analyze determinants of patient reporting activity in France in order to assess patient involvement in pharmacovigilance.MethodUsing the French national pharmacovigilance database, univariate and multivariate analyses were performed to compare the characteristics of adverse drug reaction (ADR) reports from patients and healthcare professionals (HCP) between 2011 and 2020. The relationship between regional patient ADR report activity and regional care provision and socio-professional characteristics was analyzed using the principal component analysis.ResultsA significant and higher increase in ADR reports over time from patients (r = 0.89, p < 0.001) compared to HCP (r = 0.27, p = 0.002) has been observed. Patient ADR report activities compared to HCP concerned more women (80% vs. 55%, p < 0.001), younger age classes (p < 0.001), reporting through web portal (83% vs. 17%, p < 0.001), and less serious events (26% vs. 63%, p < 0.001). In the principal component analysis, regional patient reporting activity was related to socio-professional categories, age classes, and densities of hospital beds and physicians.ConclusionOur results confirm an increasing involvement of patients in ADR report activities. The determinants of patient reporting activities are not only related to drug and medical factors but also to social factors. Digital tools may also play a role in health democracy in pharmacovigilance.