Course: MSc in Pharmaceutical Business and Technology
Pharmaceutical Business and Technology
Abstract
The reporting of adverse events is a key component of the Pharmacovigilance process. In particular in the post marketing phase,adverse event reporting plays a central role in the discovery of relatively rare and long-term drug interactions that are not typically picked up in clinical trials. This thesis investigates the determinants of success in the design of systems for adverse events in Post Marketing Surveillance Studies from the perspective of market authorisation holders. This study applies the Analytic Hierarchy Process to firstly breakdownthe design of adverse reporting systems into itsconstituent parts and then creates a ranking of these components based on asurvey of expert practitioners. In total 42 practitioners weresurveyed across three categories of practitioners, operational staff and management/medical practitioners. The results of the AHP process provides a ranking of factors that determine the success of systems for adverse reporting. The outcomeof this work providesa tool that can be used by practitioners to aid in the design of adverse reporting systems and provides sound future direction and guidance for researchers working in adverse events reporting in the pharmaceutical industry.
Investigating the determinants of success in the design of systems for Adverse Event Reporting in Post Marketing Surveillance Studies.
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Section 1. Introduction
1.1 Pharmacovigilance
Pharmacovigilance is critical to the safe and effective marketing of pharmaceutical products. The objective of pharmacovigilance is to collect information on adverse reactions in patients caused by pharmaceutical products. It involves careful analysis to verify the effectiveness of the medicinal product and subsequent disclosure of the information, including severity of observed reactions. Pharmacovigilance should occur at all stages of development of a medicinal product and continues on a permanent basis once the product has passed the marketing phase (ANVISA 2019). The exercise of pharmacovigilance has an ethical and legal role to monitor the marketing phase and large-scale use of the medicinal product to ensure patient safety. Therefore, Pharmacovigilance departments are established in the pharmaceutical industry to maintain the active and vigilant system, maintaining channels of communication with health professionals and consumers to record adverse events that have occurred during the use of medicines. (ANVISA, 2019).
1.1.1 The Pharmacovigilance Process
This thesis investigates a critical component of the pharmacovigilance process, the reporting of adverse effects in post marketing authorisation studies (PASS). Before outlining the objectives of the thesis in further detail, the role of reporting of adverse events in the pharmacovigilance process will be discussed (is illustrated). There are four basic steps in the pharmacovigilance process as outlined in figure 1.
Thetotal cost and time required increases at each stage, mainly due to the enlargement of the size of the volunteer sample. However, the initial stages involve greater technological challenge, with emphasis on phases I and II, when defining the dose of the new drug and the effectiveness of its action (Gomes et al., 2012). A description of each phase follows.
Phase 1.
The main objective of phase 1 is to assess the safety of the drug being tested for the first time in humans. At this stage, the drug is tested in increasing doses, usually in small groups of healthy volunteers (10 to 20 people). Depending on the drug studied, patients need not necessarily be healthy. However, they must necessarily be in a good clinical condition and with preserved organic functions. If the drug is shown to be safe in phase I, (one) it may proceed to Phase 2.
Phase 2
Phase 2 has the main objectives of (1)Assessingthe efficacy of a drug or regimen (sometimes referred to as the phase IIA study) and/or(2)To identify a promising treatment to be tested in phase III (phase IIB) studies. In general, a phase II study includes a larger number of patients than the phase 1 studies, but much lower than those of phase III (usually 70 to 100 patients).
Phase 3
Phase 3 is variable and in a larger scale. The goal of this phase is to compare the new drug with the standard drug or treatment in a larger number of patients (more than 1,000 patients). At this stage, the studies are randomized, that is, the patients are divided into two groups through a lottery. The groups in this phase are: control (receiving the drug or standard treatment) and case/experimental (receiving the new drug). Phase III studies are sometimes performed to verify that the combination of two drugs is better than the use of a drug alone. Studies of this phase are often referred to as comparative trials or controlled trials.
Phase 4
In this stage the studies are carried out to confirm that the results obtained in phase III are applicable in a large patient population, since the drug has already been approved for commercialization. The advantage of the studies in this phase is that they allow monitoring the effects of drugs in the long term and in large samples (tests in real life), allowing for findings that are relevant for new indications of the drug(Gomes et al.,2012).
1.1.2 Post Authorization Safety studies
Post Authorization Safety studies thus represent the final stage (Phase IV) of the iterative pharmacovigilance process as represented in figure 1 (Cohet et al., 2017). Market Authorization holders rely on phase IV studies to identify rare reactions to pharmaceutical products and reactions that occur due to long term use of the product (Cohet et al., 2017). PASS studies are therefore essential for the ongoing market authorization of products. Unlike the previous three phases, phase IV studies are done outside of the clinical environment. This creates a challenge for practitioners has they do not have direct control over the sampling of patients involved in the trial. Instead in order to detect adverse events, practitioners are reliant on the reporting of adverse events by medical practitioners. In order for this process to be effective in practice,market authorization holders must ensure there is a quality system in place.
Despite its importance for ensuring drug safety, there are increasing doubts as to the effectiveness of adverse event reporting in practice (Molokhia et al., 2009). Much of the debate in the literature however has focused on evaluating the effectiveness of systems of adverse reporting (Molokhia et al., 2009, Howell et al., 2017). Such studies raise the issue and impact of ineffective systems for adverse event reporting, however they do not provide impetuous as to how such systems can be improved.
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Section 2.Objectives and Aim
2.1 Aim
This study aims to contribute towardsthe improvement of systems for the reporting of adverse events through investigating the design of systems for adverse reporting from the perspective of the market authorization holder. Specifically,the study aims to identify which components of the system for adverse are critical for success. Through identifying the most critical components of the system, the study aims to contribute to the design of by allowing practitioners to prioritize those components that are most likely to lead to success in the design process.
2.2 Objectives
To achieve this objective, the study leverages the opinion of expert practitioners. To enable this it is firstly essential to identify the design components of adverse reporting systems.
(1) The first objective is thus to identify the design components of systems of adverse event reporting. To accomplish the first objective an extensive review of extant literature will be completed to identify a preliminary list of essential design features. Following this, preliminary interviews will be completed with practitioners to verify the identified design components.
(2) The second objective is to identify the criticality of various design components. To achieve this, the analytic hierarchy process was chosen as the methodology. AHP was developed by Saaty, (1973) and involves structuring a problem into components in a manner that enables the comparison of various solutions to a problem in terms of its critical components. A key aspect of thisapproach is to rank the importance of the various components, thus allowing for inference into the relative criticality of thecomponentsthemselves. Therefore, to achieve the second objective an AHP analysis will be completed using survey data generatedby this study from expert practitioners.
(3) The third objective is to examine the extent to which opinions regarding the criticality of various design components vary across types of practitioners.Lastly it is recognized that practitioners in various roles may have differentopinions regarding the criticality of various design components. Not allowing for this and aggregating, may bias the results.
The remainder of the study is structured as follows: Section 3contains a review of relevant literature. Section 4outlines the methodology employed in the study. Section 5 detailsthe results of the study. Finally section6discusses the implications of the results and conclusion.
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Section 3. Literature review
3.1 Introduction
This chapter will present a narrative review of the literature which will supportthe results and discussionof this study.
The Institute of Medicine (IOM) of the United States of America (US), defines the quality of healthcare as ‘the degree to which healthcare services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge' (ANVISA, 2019). Kohn et al., (1999) describe a paper published by the IOM in which it is reported that approximately 44,000 to 88,000 patients die each year in US hospitals because of injuries caused during provision of health care. This IOM study generated concernsabout the quality of health care. Subsequent to the findings of the report, national and supranational organizations mobilized and initiated strategies for the prevention of failures of interventions in health care.
In 2002, the Fifty-fifth World Health Assembly on the "Quality of Care: Patient Safety" tasked the World Health Organization (WHO) to establish standards and support countries for the development of policies and practices for patient safety. In 2004, the Global challenge initiative, part of the Alliance project World Congress on Patient Safety identified challenges which guided the identification of 26 actions that help avoid risks for patients and the countries in which they should be implemented. (Riehle et al., 2013). This is the Patient Safety Program which aims to coordinate, disseminate and accelerate the progress in patient safety around the world (Riehle et al., 2013).
As the use of medicinal products is a key component of the treatment of patients, the effectiveness and safety of drugs is key to patient safety. Information regarding the safety of drugs is generated in the pharmacovigilance process. As outlined in the introduction chapter this study aims to investigate systems of adverse reporting in phase IV studies. To illustrate the role of adverse reporting systems in the context of PASS studies, the literature on PASS studies will be firstly explored in more detail.
PASS studies are increasingly important given the frequency of occurrence of drug recalls and the emergence of additional risks post initial-marketing. To illustrate this, Gough (2005) identifies two prominent examples. Firstly, Astra Deneca had to issue a "Dear Doctor" letter in June 2004, to outline the risk of rhabdomyolysis with the drug marketed as Crestor (rosuvastin) (Gough, 2005). In addition, Merck had to withdraw rofecoxib (Vioxx) due to an increased risk of cardiovascular disease following 18 months of use (Gough, 2005). As a result of the increasing rate of product recalls in medicinal products, new regulations have been introduced to improve safety of patients across Europe.
With the new pharmacovigilance legislation, effective in 2012, a Marketing Authorization (MA) may be conditionally granted, with a requirement that the Marketing Authorization Holder conducts post- authorization efficacy studies in case concerns relating to some aspects of the efficacy of the medicinal product are identified and can be resolved only after the medicinal product has been marketed. The new Directive 2001/83/EC states that PASS studies must cover not only on-label as was stated in the previous directive, but also off-label studies. Thus implying that any new safety information, based on the studies conducted outside the scope of the market authorization, MA, ought to be communicated and be taken as part of the risk/benefit analysis of the product. The implications of this new legislation is to ensure appropriate study design and analysis so that incorrect or premature conclusions do not drive decisions regarding product safety. Study design thus needs to be tailored to particular products and safety concerns, where different principles are applied in different situations (European Medicines Agency, 2012).
The procedures by which PASS studies are evaluated are subject to uncertainty. In an attempt to provide improved certainty, the European Medical Agency introduced guidelines for the design and registration of PASS studies (European Medicines Agency, 2012). The protocol outlined a number of design options including various types of active surveillance studies, observational studies and clinical trials. The protocol states that the best design is contingent on the objectives required. As such, there is significant scope available to practitioners in the design of PASS studies.
A critical component of the design of a PASSstudy is the establishment of a system for the reporting of adverse events. The occurrence and the reporting of adverse events has an important impact on the Health System because of the increase in morbidity, mortality, time of treatment of patients and costs assistance in other fields of social life and economic development (ANVISA, 2019). The purpose of reporting adverse events is to inform managers, and thus establish improvement measures, allowing for learning among healthcare professionals from the shortcomings found.
3.2 Reporting of Adverse events in Practice
The reporting of adverse events in the post-marketing stage of the pharmacovigilance process is particularly important as during earlier stage clinical trials there is too small a sample size to identify all potential adverse reactions (Molokhia et al., 2009). In particular clinical trials are not best suited to the identification of particularly rare adverse events or adverse events that are attributable to long term use. The aforementioned seminal report by the Institute of Medicine published in 1999 "to err is human",identified as part of its overall recommendations a greater emphasis on adverse event reporting (Molokhia et al., 2009). The report cites the use of adverse reporting in other high risk industries, particularly aviation, as a system to follow. Following this report there has been a great deal of attention been given to improving national systems for adverse event reporting from a regulatory standpoint (Mitchell et al., 2016). This has led to a huge increase in the volume of adverse events being reported every year. For example, under the UK system, approximately 1.5millionincidents are reported every year (Mitchell et al., 2016). The majority of these reports are spontaneous reports arising in the post authorization phase. Typically these reports are generated by systems whereby clinical practioners report to market authorization holders who then report to national or supranational databases.
As outlined above,the major legislation governing the practice of clinical trials is Directive 2001/83/EC. Most recently, the European Medicine Agency released a series of guidelines outlining the requirements for market authorization holders regarding the reporting of adverse events (European Medicines Agency, 2017). Under the regulation (Art 104(1), Art 107(1) of the directive) each market authorization holder is required to have in place a system for the collection, recording and reporting of suspected adverse events that are brought to its attention. In addition all suspected adverse events must be stored electronically and made available for further follow-up and inspection. Reports must be kept for 10 years after the market authorization permit has ceased. In Europe adverse reports must also be recorded in the Eudravigilance database that is maintained by the European Medicine Agency. Despite the development of a detailed regulatory framework and increase in the prevalence of adverse reporting both in the EU and worldwide, there is still significant uncertainty as to the effectiveness of adverse reporting in ensuring drug safety. Some of the most recent studies examining this topic will be explored in turn.
A large number of studies have sought to examine the success of adverse reporting schemes through the examination of trends in incidence of adverse reports (Shojania and Thomas, 2013). Most recently Landrigan et al., (2010) observed no significant reductions in the harm or preventable harm rate in 10 US hospitals due to patient safety initiatives. Classen et al., (2011) found in a case study in the US that standard tools to measure adverse events in hospitals were underreporting up to 90% of total adverse events. Finally Baines et al., (2013) found that there was no improvement in the rate of non-preventable adverse rates in the Netherlands. These studies point to a lack of significant impact of schemes to improve adverse events on improvements in safety.
Mitchell et al., (2016) investigated issues related to adverse event reporting in the United States. The authors conducted thematic analysis based on semi-structured interviews conducted with leading experts on patient safety in the US. They identified 5 factors explaining current inadequacies in the US system. Namely, inadequate report processes, lack of adequate medical engagement, insufficient action from the regulator, insufficient funding and institutional support and failure to capture evolving health information technology developments. Howell et al., (2017) used a Delphi approach to capture experts' opinions regarding initiatives to improve adverse event reporting at an international level. The paper produced forty recommendations. The most prominent recommendations highlighted by the paper were that reporting systems should not be used as a tool to appraise hospitals and the recommendation for more healthcare professional training.
These studies point toward a need for improved systems for the collection of adverse reporting on the part of both regulatory bodies and market authorisation holders. The studies point toward steps that can improve such systems however do not necessarily deal with how to design these systems from an operational perspective. In the next section literature that deals with the design of Adverse Reporting Systems will be examined from the Market Authorisation Holders perspective.
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3.3 Literature that reviews the design of systems for adverse events
In addition to literature that evaluates the effectiveness of adverse event reporting, there is also literature on the design of systems for adverse reporting from the perspective of Market Authorization holders. For thiscurrent research,two sources were found to be particularly relevant. Firstly, the European Medicines Agency (2017) published a guideline on good pharmacovigilance practice in relation to the reporting of adverse events in the pharmacovigilance process. Thisguideline presents detailed recommendations on the establishment of a system for adverse event reporting in phase IV trials and post marketing studies. The report identified the following key processes; collection of data, processing of data, reporting of data and data management.
Secondly, Becker et al., (2003) focuses more on the factors that lead to success in the reporting of adverse events in the pharmacovigilance process. In line with the EMA guidelines they outline three key processes in a pharmacovigilance reporting system, namely collection of safety information, processing and reporting of safety information and safety information management (Becker et al., 2003). In terms of the first process, (collecting of information), the author's identify the following: the importance of training both reporters and the reporters of information, the management of information, the use of standardized forms and a quality medical dictionary. Regarding the second process the authors outline the importance of well-defined work flow responsibilities, an effective safety database, and effective and regularly updated safety operating procedures. Finally in relation to the last process the authors identify the importance of the query process an effective system for the description and evaluation of signals and finally appropriate statistical and data storage capabilities.
Becker et al., (2003) further highlights the increasing role of Clinical Research Organizations in the design and management of adverse event reporting systems. Increasing costs and complexity in operations has incentivized market authorization holders to outsource responsibility for the conducting of pharmacovigilance processes to specialized organizations. Popescu et al., (2012) is more formal in its analysis of the CRO industry and highlights that pharmaceutical companies are increasingly downsizing their operations to focus on their core skills and specialties. Citing lack of in-house capacity, skill deficiency, and most importantly cost control in influencing the trend toward outsourcing. Looking forward Grand View Research (2018) forecasts the CRO industry to continue to grow rising to a value of $55 billion dollars in 2025. CRO's as such provide an increasingly important role in the pharmacovigilance process.
While EMA (2017) and Becker el al., (2003) deal with the design of systems for adverse event reporting directly, many other studies deal with elements of adverse event reporting. A number of studies examined the use of databases for signal detection. Moulis et al., (2012) examine the reporting of adverse events post market authorization. The authors examine the French Pharmacovigilance system for serious and non-adverse reports. The authors complete linear trend analysis on reported cases to examine the volume and rate at which non-adverse events are reported relative to serious events. Results indicate that in the immediate years more non-serious events are reported, however in later years more serious reports are reported as the volume of non-serious events decreases. The reason given for the reduction in volume of non-serious events is that after the initial years of post-market authorization most non-serious adverse events become known.
Blake et al., (2014) explored the use of database mining of safety databases to provide evidence for drug reactions. The authors specifically examined the difference in reporting for adult and pediatric adverse events. The authors found that database mining was an effective tool for providing evidence in response to medical queries. Specifically the authors confirmed that reports of reactions in children were different to those in adults, not only in terms of reactions and drugs involved but also more concentrated around limited sets of reaction types and drugs.
Fukazawa et al., (2018) similarly sought to verify the effectiveness of data mining methods for signal detection by spontaneous reports. The authors examined extant signals identified from reports from the Federal Drug Association. The authors found that data mining is effective for early detection of safety issues for newly marketed drugs. The continuous monitoring of safety issues for old drugs, and signal detection of nonserious AEs to which little attention is usually given.
Rorie et al., (2017) addressed the advantages of electronic data capture through an extensive review of the literature. The authors found that the major advantage of Electronic data capture (EDC) over paper-based systems of research is that it is able to detect protocol violations and data"outside the normal range at the time of entry and not days, weeks or months after". In addition EDC improve the quality of trials, are more cost effective, improve data quality and productivity. Limitations identified included lack of available technical support, a lack of investigator motivation, complexity of installation, maintenance of software, high initial investment cost, and complexity of use.
In addition to the examination of databases a number of studies created tools for the improvement of adverse reporting. Lee et al., (2019) examined the importance of coding systems for reporting. The authors develop a medical coding system and dictionary. Coding of results is a critical component of the accurate reporting and processing of adverse events. The authors aim to provide a semantically enriched adverse drug reaction (ADR) dictionary for post-market drug safety research and enable multicenter EHR-based extensive ADR signal detection and evaluation. To achieve the objective the reporters create a comprehensive controlled vocabulary-based ADR signal dictionary (CVAD). The authors validate their results through a clinical review by medical professionals and a detailed analysis of a number of specific reaction types.
Lu (2010), similar to Lee et al., (2019) examined the creation of standardized forms for improved accuracy of coding. The authors however focused primarily on the design of electronic case report forms (eCRFs). The author conducted a systematic review of the literature to identify the key aspects, processes, standards, recommendations, and best practices in designing eCRFs. The authors identified the following as the key aspects toward the design of eCRFs.
a. To identify required data elements from the study protocol supporting data analyses and reporting requirements.
b. The application of accepted best practices, CDASH & CDISC guidelines, and company internal or therapeutic unit standard
c. TheMapping of coding (MedDRA) should be implemented and managed.
d. (Lastly) That Electronic Data capture technologies should be monitored to ensure compliance of eCRFs
Rodrigues et al., (2018) examine signal detection and the use of statistical methods to improve the rate of signal detection and assessment of causality in adverse event reporting. The authors create and trial a Bayesian network approach to signal detection. The model was trailed in Portugal over a three year period. The authors found that the model improved assessment of causality in cases with high levels of causality (above 80%). The model however still struggled to improve assessment of causality in cases with lower levels of causality. A key innovation of the model was the use of a visual interactive interface that allowed for visualization of interactions between causal factors and events. This allowed for improved feedback for users of the system. This was found to be an improvement on existing systems which rely on decision trees and neural networks. This is mainly attributed to the ease of understanding of the visual interface relative to these other methods.
Molokhia et al., (2009) use a systematic review of the literature to evaluate methods to improve the reporting of adverse events. The authors firstly identify the use of educational interventions to improve spontaneous reporting rates, finding a positive effect in the literature. Chart reviews, questionnaires and patient interviews were found to be useful sources of information but are associated with a high use of time resources. Improved coding of events to improve the quality of data reported is further identified along with improved statistical analysis of resulting events. Finally the authors argue in favour of the improvement of existing safety databases given advances in digitalisation.
In addition, Palleria et al., (2018) developed a system to train the reporters of cases in post-marketing studies. This system was trialed in Italy with physicians involved in the treatment of rheumatology with biologics. During the study period 399 patients with active rheumatology were observed. 125 adverse events were reported during the period of which the most common adverse event reactions were injection site reactions and skin disorders. To examine the effectiveness of the system for improving adverse event the results were compared with pre trial adverse event reporting for an equivalent period and number of patients. The results provided evidence of improved reporting of adverse events. Similarly Leistikow et al., (2017) focus on training of reporters and propose a new system for training reporters in Dutch hospitals.
Harinstein et al., (2018) examined the effectiveness of industry led programs in signal detection relative to non-industry led programs for adverse event reporting. The authors picked a set of cases based on pre-identified criteria, the study evaluated reports based on differences in reporters, outcomes, data completeness, and usefulness (usefulness of individual case safety reports was assessed by manually reviewing the availability of key information in the narrative including temporality and comorbidity). The authors concluded that industry led reports contain more data but are similar in usefulness in relation to non-industry led programs.
Portnoff and Lewis, (2017) examined the nature of market authorization holder sponsored patient support programs and their association with adverse event reporting. Patient support programs are designed to help improve the reporting of adverse events and are a form of organized data collection scheme. The research involved the survey of market authorization holders to examine the methods, techniques and scope of pharmacovigilance activities in use. The results indicated a degree of variation in use of system across respondents. The authors highlight a need for increased oversight to improve consistency of programs across organizations.
Finally a series of studies looked at general factors that lead to better systems for adverse reporting. Avery et al., (2011) investigate the reporting of adverse events in the UK yellow card system from the perspective of the reporters. The study contains both a qualitative and quantitative analysis of reporter's attitudes to the current reporting system. The quantitative analysis includes analysis of survey responses of over 2000 reporters across a number of types. The qualitative analysis consists of a panel discussion of over 40 practioners. The reports find that patient reports contained a higher number of adverse reactions per report, a higher number of serious cases and better descriptions. The findings indicate that most reporters found it easy to make reports however there were a number of suggestions. Suggestions included greater publicity and redesign of web and paper based reporting systems.
Aagaard et al., (2012) analyzed the link between national income of a country and propensity to report adverse events. To complete the study, the study examined 1,359,067 adverse events on the vigibase database. The authors found that high income countries had the highest rate of reporting and low income countries the lowest. Further the study found that a high degree of variation between different types of reactions across countries. The authors call for a strengthening of reporting rates in poorer countries.
Lastly Moore et al., (2016) assessed the completeness of reports the Food and Drug Administration received in 2014 in order to identify areas for improvement. The study identified that in 2014 the FDA received 528,192 case reports with 95.3% coming directly from market authorization holders and 4.7% coming from direct reporters. It was found that reports coming from market authorization holders were less complete at 40.4% in comparison to direct reports at 86.2% complete. The authors called for increased accuracy for market authorization holders.
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3.4 Contributions of this study
The reporting of adverse events is a critical component in the establishment of the safety and efficacy of newly authorized medicines (Moore et al., 2016).Over the last thirty years the improvement in the reporting of adverse events has been an important component of the literature on effective pharmacovigilance. Recent legislation establishes the role of market authorization holders in ensuring that adverse events are effectively reported. As identified by Moore et al., (2016) however there is frequently questions as to the quality of reports generated from Market Authorization Holders. This study aims to contribute toward the improvement of the systems that are used by Market Authorization holders for reporting of adverse events.
EMA's Good Pharmacovigilance Practices clearly outlines the requirements for market authorization holders in terms of key process for their respective reporting systems under the current legislation. In addition as detailed in the last section there is an increasing literature on the improvement of systems for adverse event reporting. This study aims to build on this literature to examine which factors are most critical in the effective reporting of adverse events in post marketing surveillance. Through identifying the most critical factors that influence the success of the relevant system the study will provide valuable insight for practitioners into which factors are most crucial to prioritize in the design and management of reporting systems. In addition it is clear that Market Authorization Holders are equally reliant on reporters and in particular medical practioners in the successful design and implementation of systems for adverse reporting. This study will also identify the critically of various factors in the design of systems from the perspective of medical reporters (Avery et al., 2011; Palleria et al., 2018).
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