Quality Of Adverse Drug Reaction Reports Research Articles

Time series analysis of using the PDCA method combined with the Teach-back method to improve spontaneous reports of adverse drug reactions in a grade IIIA hospital in China.

Spontaneous reporting of adverse drug reactions (ADRs) is essential for the post-marketing safety evaluation of drugs. Therefore, good monitoring of ADRs is vital for strengthening drug supervision, management, and guiding rational drug use. Chinese medical institutions are the primary source of ADR case reports, but the proportion of the reports in grade IIIA hospitals is still low due to serious under-reporting. The 3rd Affiliated Hospital of Chengdu Medical College, Chengdu Pidu District People's Hospital, also has such a problem. To improve the quantity and quality of ADR reports and enhance the level of pharmacovigilance in hospitals, the Third Affiliated Hospital of Chengdu Medical College, People's Hospital of Chengdu Pidu District experienced 10years to gradually establish a management model to improve the medical staff's reporting rate of spontaneous reporting of ADRs. The management model is led by clinical pharmacists and combines the PDCA with Teach-back methods. The purpose of this paper is to introduce the management model and discuss its advantages and shortcomings of this model. This study was conducted at the Third Affiliated Hospital of Chengdu Medical College-Chengdu Pidu District People's Hospital. From 2016, the daily management of reporting, auditing, and data improvement of adverse drug reactions in the hospital was carried out by clinical pharmacists, who used the PDCA method combined with the Teach-back method to continuously improve the reporting program of ADRs in the hospital during 2016-2021. Then, the proportion of spontaneous reports of total, new, and serious ADRs was compared before and after the intervention. Also, we performed a time series analysis using an autoregressive moving average model to assess changes in the total number of spontaneous ADR reports before the intervention (2013-2015), the first intervention (2016-2018), and the second intervention (2019-2021). After the combined PDCA and Teach-back method intervention, the median number of reported ADRs per year increased from 50 (range 37-55) in the pre-intervention period to 88 (range 83-162) in the first intervention period and to 374 in the second (range 312-566). Breakpoint regression analysis of the spontaneous reporting rate of ADRs showed that the instantaneous increase after the first intervention was not statistically significant (P = 0.526). However, the reporting rate of ADRs increased at a month-by-month growth rate during the second intervention compared to the first intervention. Its spontaneous reporting rate improved 1.034 times (P = 0.002). After the second intervention, the spontaneous reporting rate of ADRs transiently increased 6.111-fold (P < 0.001), and the month-to-month growth rate increased 1.024-fold (P < 0.001) again. The management model that combines the PDCA and the Teach-back method significantly improves the reporting rate of adverse drug reactions.

Patient's reporting of adverse drug reactions: Which added value in 2023?

Several studies were focused on the qualitative and quantitative analysis of serious adverse drug reactions (ADRs) leading to hospitalisation or death. These figures do not take into account ADRs in ambulatory patients affecting their quality of life. Patient reporting has the advantages of bringing novel information about ADRs. It provides a more detailed description of ADRs, and reports about different drugs and system organ classes when compared with health care professional (HCP) reporting. A certain amount of information is crucial in order to determine the drug-reaction relationship. European regulation and patient support programs have contributed widely to increased patient reporting but the quality of ADR reports is still unequal from one country to another. Patient reports of ADRs have contributed enormously to pharmacovigilance signal detection in a number of ways. Over the last decades, countries have developed dedicated websites for direct patient reporting. The increasing involvement of patients in ADR reporting activities facilitated by a web portal was confirmed by some studies. Patients are now recognised as having a legitimate part to play in the decision-making process. The contribution of patient reports to drug safety was acknowledged and consolidated by European Union (EU) PV legislation in 2012 aiming to involve patients more actively, nowadays called "patient centricity in pharmacovigilance". Patient organisations are involved in regulatory issues and collaborate with health institutions on the development of guidelines. However, some studies suggested that a substantial number of patient organisations have potential financial conflicts of interest but limited disclosure practices. Pharmaceutical companies integrate into patient associations, particularly for chronic diseases by different strategies: educational therapeutic or observance support programs. The question of conflict of interest of patient associations is important requiring better transparency.

Pharmacovigilance in Saudi Arabia: A Narrative Review on Adverse Drug Reaction Reporting

Adverse drug reaction (ADR) reporting is an important aspect of pharmacovigilance (PV) in ensuring drug safety during the post-marketing surveillance phase. Currently, the National Pharmacovigilance Center (NPC) established by the Saudi Food and Drug Authority (SFDA) is the regulatory authority receiving ADR reports in Saudi Arabia. Spontaneous ADR reports from healthcare professionals and the public are received by the NPC through an electronic platform known as the Saudi Vigilance System. Signal analysis of the received ADR reports aids the decision-making initiatives related to the reported drugs. Stakeholders’ contribution to ADR reporting, and implementation of effective electronic platforms are important factors affecting the national PV performance. The concept of stakeholders reporting on ADR is relatively new in Saudi Arabia, especially to the public. In this narrative review the national studies describing the stakeholders’ knowledge, perception and barriers toward ADR reporting, and the incidence of ADR reporting by healthcare institutions in Saudi Arabia were evaluated. The findings indicate that more efforts are needed by the SFDA to educate stakeholders about the importance of ADR reporting. The study recommends ADR electronic systems integration between the SFDA and healthcare institutions to improve the frequency and quality of ADR reports, and regular feedback on decisions made about ADR reports should be provided by the SFDA to stakeholders to improve their awareness of the importance of ADR reporting and enhance their contribution to PV and ADR reporting process.

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.

The quality assessment of theJapanese Adverse Drug Event Report database using vigiGrade.

Background The quality of adverse drug reaction reports can have a strong influence on the causality assessment or the detection of safety signals. Various methods have been used to evaluate the quality of adverse drug reactionreports. Objective We used the vigiGrade completeness score to evaluate the quality of the Japanese adverse drug event report database (JADER). Methods Among all reports in the JADER (cases received by regulatory authorities from April 2004 to November 2018), 427,797 cases that did not meet the exclusion criteria were analyzed using vigiGrade. An report was considered a 'well-documented' report if the completeness score > 0.8. For each dimension, the proportion of incomplete information was calculated. Main outcome measure Proportion of 'well-documented' reports. Results A total of 211,774 (49.5%) cases were classified as 'well-documented' reports. When classified by sender, 6240 out of 8257 cases (75.6%) from medical institutions were 'well-documented', while 205,534 out of 419,540 cases (49.0%) from pharmaceutical companies were categorized as such. 'Time-to-onset' could not be calculated in 173,027 (41.2%) cases from the pharmaceutical companies and in 1228 (14.9%) cases from medical institutions. Conclusion In the JADER, the proportion of 'well-documented' adverse drug reactionreports from medical institutions was higher than that from pharmaceutical companies, and reports from medical institutions could help to clarify generated safety signals. We also found that more than 40% of the reports from pharmaceutical companies did not include information that is considered essential for the evaluation of any causal relationship between suspected drugs and adverse drug reactions, which could pose challenges to the detection of safety signals.

Effect of Educational Interventions on Adverse Drug Reaction Reporting in a Cancer Institute in Japan: A Questionnaire Study.

Background: Limited data regarding knowledge and factors related to understanding the adverse drug reaction (ADR) reporting system of health care professionals are available in Japan. Objective: The objective of this study was to identify factors related to understanding the ADR reporting system in Miyagi Cancer Center and to find ways to increase the number and quality of ADR reports. Methods: Self-administered questionnaire surveys were administered before and after the educational meeting among health care professionals who were working in our hospital during the study period. Subanalyses restricted to nurses were also performed. Main Outcome Measure: Understanding ADR reporting system among healthcare professionals. Results: The percentage of respondents who understood the ADR reporting system in the questionnaire after the educational meeting was significantly higher than that in the questionnaire before the educational meeting. In the questionnaire after the educational meeting, multivariate logistic regression analysis found that having over 30 years of practical experience (odds ratio [OR], 3.852; 95% confidence interval [CI], 1.228-12.081 for 20-29 years, 7.695; 1.650-35.881 for over 30 years), being a physician (8.071; 1.923-33.878), being a pharmacist (18.357; 3.847-87.585), and participating in the educational meeting (5.111; 1.700-15.365) were factors associated with understanding the ADR reporting system. Multivariate logistic regression analysis of the questionnaire results before the educational meeting among nurses showed that working at outpatient departments (8.330; 3.008-23.069) was significantly and independently associated with understanding the ADR reporting system. Conclusions: The present study demonstrated that many years of practical experience, profession (physicians, pharmacists), and educational interventions were associated with good understanding of the ADR reporting system among health care professionals.

FarmaREL: An Italian pharmacovigilance project to monitor and evaluate adverse drug reactions in haematologic patients.

Adverse drug reactions (ADRs) reduce patients' quality of life, increase mortality and morbidity, and have a negative economic impact on healthcare systems. Nevertheless, the importance of ADR reporting is often underestimated. The project "FarmaREL" has been developed to monitor and evaluate ADRs in haematological patients and to increase pharmacovigilance culture among haematology specialists. In 13 haematology units, based in Lombardy, Italy, a dedicated specialist with the task of encouraging ADRs reporting and sensitizing healthcare professionals to pharmacovigilance has been assigned. The ADRs occurring in haematological patients were collected electronically and then analysed with multiple logistic regression. Between January 2009 and December 2011, 887 reports were collected. The number of ADRs was higher in older adults (528; 59%), in male (490; 55%), and in non-Hodgkin lymphoma patients (343; 39%). Most reactions were severe (45% required or prolonged hospitalization), but in most cases, they were fully resolved at the time of reporting. According to Schumock and Thornton criteria, a percentage of ADRs as high as 7% was found to be preventable versus 2% according to reporter opinion. Patients' haematological diagnosis, not age or gender, resulted to be the variable that most influenced ADR, in particular severity and outcome. The employment of personnel specifically dedicated to pharmacovigilance is a successful strategy to improve the number and quality of ADR reports. "FarmaREL", the first programme of active pharmacovigilance in oncohaematologic patients, significantly contributed to reach the WHO "Gold Standard" for pharmacovigilance in Lombardy, Italy.

An Educational Intervention To Improve Nurses Reporting of Adverse Drug Reactions

AN EduCATioNAl iNTErVENTioN To improVE NurSES rEporTiNg of AdVErSE drug rEACTioNS S. Marquez; M.T. Herdeiro; and I. Ribeiro-Vaz University of Aveiro, Aveiro, Portugal; and Northern Pharmacovigilance Centre, Porto, Portugal Introduction: Adverse drug reactions (ADR) are an important cause of mortality and morbidity leading to additional costs with health. Drug safety data before commercialization is limited and incomplete, which is the reason why pharmacovigilance is important. ADR reporting system is efficient in drug safety monitoring. Nurses can have an important role in ADR reporting due to their daily activities of drugs administration (including vaccines). However, among these professionals, there a high rate of underreporting. Based on the reasons proposed by Inman for underreporting ADR, it was concluded that the main obstacles to ADR reporting among nurses were indifference (the belief that a single case cannot contribute to medical knowledge) and the lack of knowledge about the pharmacovigilance system. The aim of this study is to evaluate the quantitative and qualitative increase of ADR reports by nurses after an educational intervention. Methods: A quasiexperimental study was performed in nurses working in primary care in Braga district, Portugal. One hundred thirteen individuals were placed in the intervention group while the control group included 590 nurses. Two educational interventions were performed to nurses working in primary care in ACES Cavado II (intervention group) that focused on the problem of adverse drug reaction, the impact on public health and spontaneous reporting. Statistical analysis were based on absolute and relative frequencies. Results: Between January 2013 and September 2014 the Northern Pharmacovigilance Centre received 8 reports/100 nurses from the intervention group and 5 reports/100 nurses from control group. Conclusions: The educational intervention increased 1.6 times the number of reports during the study period. The second intervention had more impact than the first one. There was no significant increase in the quality of ADR reports in the intervention group. In the second intervention the number of reports increased only at the intervention day.

Quality of Adverse Drug Reaction (QADRA) reports: an algorithm to appraise the efficiency of spontaneous reporting systems in pharmacovigilance

To design and validate an algorithm for the multidimensional evaluation of the quality of adverse drug reaction (ADR) case reports (QADRA). One hundred fifty-three patients randomly and retrospectively selected from 15,906 records included in the Italian database of spontaneous ADR reports throughout 2009. Each report was evaluated by two panels of experts blinded to one another as well as by the algorithm developed in the present study. Each case was classified taking three parameters into consideration: plausibility, notoriety and clinical relevance. The two panels assessed that 21.6 % of reports were of “high” quality. When applying the QADRA algorithm (score range 0–15), its median value was 6 (4–7, 25 and 75 percentiles, respectively). The area under the receiver operator characteristics (ROC) curve, which assesses the ability of the risk score to predict the report quality, was 0.93 (95 % CI: 0.88–0.97). Herein, the cut-off points ≤5, 6 or 7 and ≥8 indicated the best balance between sensitivity and specificity, and they could be used to categorize the reports as being of ‘high’, ‘intermediate’ and ‘low’ quality (AUC = 0.87; 95 % CI: 0.80–0.92), respectively. The QADRA algorithm performs as a reliable and complete tool for assessing the quality of ADR reports. Several potential applications of this algorithm should be investigated in the future, both for scientific purposes and healthcare system management.

Detection and reporting of drug-induced proarrhythmias: room for improvement

Recently adopted guidelines mandate the inclusion of detailed non-clinical and clinical QT data in future drug labels. As a result of increasing recognition of drug-induced proarrhythmias, and the bias introduced by the prescribing physician's awareness of these events, it is likely that the number of adverse drug reaction (ADR) reports of life-threatening ventricular arrhythmias and sudden death, allegedly caused by the drug, will increase. To illustrate how different approaches have been used to assess proarrhythmic liability and validate ADR reports on serious ventricular arrhythmias, this overview assesses pharmacoepidemiology studies on terfenadine and cisapride, the quality of ADR reports and the effect of label changes on prescribing patterns and other information to prescribing physicians. Clinical and pharmacoepidemiology studies, which in most cases did not demonstrate an increased risk for proarrhythmias with these two drugs, are discussed with emphasis on limitations, studied endpoints, and populations. Recommendations are made on how to improve the effectiveness of labelled precautions and contraindications, which may include the implementation of more effective alert systems. Given the low incidence of drug-induced proarrhythmias, 'signal' generation through ADR reports will continue to have a key role for early identification of proarrhythmic liability of newly marketed drugs. The quality of these reports varies widely, and can be improved through implementation of procedures by which complementary information is captured and events are adjudicated and classified into confidence categories using a consistent scheme across different classes of drugs.

The role of hospital and community pharmacists in pharmacovigilance

In this paper, we give an overview of the role pharmacists actually have and could have in collecting reports of adverse drug reactions (ADRs) and more widely in pharmacovigilance. In the literature, several ways are mentioned in which the pharmacist, both the community pharmacist and the hospital pharmacist, can contribute to the safe use of drugs. In addition to their responsibilities regarding drug dispensing and compliance, they can have a substantial role in ADR reporting. Especially, hospital pharmacists can play a significant role in ADR reporting because the most serious adverse drug events occur in hospitals, and ADRs account for a substantial proportion of hospital admissions. Community pharmacists, however, can also play an important role in ADR reporting. This is, for example, the case in the Netherlands where community pharmacists contribute substantially, both in numbers and in quality of ADR reports. The contribution of the pharmacist to pharmacovigilance should, however, not be limited to ADR reporting. The various pharmaceutical disciplines could also greatly enhance our understanding of the nature of ADRs. If those involved in pharmaceutical disciplines can rise to this challenge, they will significantly help deepen our insights into ADRs.

Pharmacists' role in reporting adverse drug reactions in an international perspective.

The participation of the pharmacist in national spontaneous reporting systems for adverse drug reactions (ADRs) has not always been a matter of course. Even today, there are a number of countries, in particular the Scandinavian countries, where pharmacists are not authorised to report ADRs. In those countries in which they are allowed to report, they do not always use this opportunity. We have conducted a review of the literature to investigate the involvement of pharmacists in ADR reporting. In addition, we evaluated the pharmacists' actual contributions in 2001 by means of an international questionnaire-based survey among the countries participating in the WHO Drug Monitoring Programme in September 2002. Apart from the numbers of pharmacists' reports, respondents were asked to indicate their assessment of both the quality and the significance of the contribution. Of the 68 participating countries, 41 responded by returning the questionnaire. The appreciation of pharmacists' ADR reports is high in those countries that have more experience with greater numbers of pharmacists' reports. The countries that received fewer reports from pharmacists gave lower scores to their contribution. If the specific contribution pharmacists can make to the quantity and quality of ADR reports were to be exploited to a greater extent, this could lead to a substantial improvement of the international adverse drug reactions reporting system.

Multidisciplinary adverse drug reaction surveillance program

Initial experience with a multidisciplinary adverse drug reaction (ADR) surveillance program at a 350-bed community hospital center is described. The pharmacy and quality-review (QR) departments developed a program that was incrementally incorporated into the hospital's overall QR activity. After inservice training, nurses and QR personnel were asked to complete an "alert" card for every suspected ADR and send it to the pharmacy. In addition, medical records were reviewed retrospectively for disease classification codes related to drug toxicity and unspecified adverse effects. Laboratory and utilization-review personnel also conducted retrospective reviews. A pharmacist reviewed all ADR reports and categorized each according to the severity of the reaction and the probability that it was drug related. For each reaction classified as severe, the patient's chart underwent physician peer review for appropriateness of therapy, avoidability of the reaction, and adequate documentation; related patient-care issues were addressed by the medical staff as part of routine quality-review activities. When problems with prescribing were identified, the pharmacy and therapeutics committee intervened with the prescribers or recommended further medical staff review. Drugs repeatedly associated with ADRs became the focus of drug-use reviews. The number of ADR reports increased from 0 to 134 in the first 11 months of the program. A multidisciplinary approach to ADR reporting increased the number and quality of ADR reports.