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Introduction Registries that collect information on specific drugs and medical devices need to anticipate the need Aes case analysis adverse event AE detection, processing, and reporting.
This chapter addresses the identification, processing, and reporting of AEs detected in situations in which a registry has contact with individual patients. This document is not Aes case analysis formal regulatory or legal document; therefore, any information or suggestions presented herein do not supersede, replace, or otherwise interpret Federal guidance documents that touch on these subjects.
Registry sponsors are encouraged to discuss plans for AE collection and processing with local health authorities when planning a registry. This chapter primarily focuses on AEs related to pharmaceutical products. Medical devices are significantly different from pharmaceutical products in the manner in which AEs and product problems complaints present themselves, in the etiology of their occurrence, and in the regulation governing the defining and reporting of these occurrences, as well as postapproval study requirements.
Other sources provide more information about defining and reporting device-related AEs and product problems, and about postmarketing studies including those involving registries. Food and Drug Administration FDA defines an adverse drug experience as any AE associated with the use of a drug in humans, whether or not considered drug related, 4 while the International Conference on Harmonisation ICH guideline ICH E2A similarly defines an AE as an untoward medical occurrence in a patient administered a pharmaceutical product, whether or not the occurrence is related to or considered to have a causal relationship with the treatment.
Prior to marketing approval, relatedness is an additional determinant for reporting events occurring during clinical trials or preclinical studies associated with investigational new drugs and biologics.
For AEs occurring in postapproval studies and reported during planned contacts and active solicitation of information from patients, as when registries collect data regarding one or more FDA-approved products, 67 the requirements for mandatory reporting also include whether there is a reasonable possibility that the drug caused the adverse experience.
The medical device reporting regulations differ from those for drugs and biologics in that reportable events include both AEs and problems with the device itself.
With the passing of the FDA Amendments Act in September and the increased emphasis on ongoing monitoring of safety profiles, evaluation of risks unknown at the time of product approval, and proactive detection of potential safety issues, registries increasingly continue to be used to fulfill safety-related objectives.
The FDA maintains MedWatch, a Web-based reporting system that allows consumers and health professionals to voluntarily report serious adverse events and other serious problems that they suspect are associated with the use of an FDA-regulated product.
However, in addition to direct data collection, AEs can be detected through retrospective analysis of a population database, where direct patient or health care provider contact does not occur. Patient interactions include clinical interactions and data collection by phone, Internet, or other means; perusal of electronic medical records or insurance claims data would not be considered direct patient interaction.
Reporting is rarely required for individual AEs observed in aggregate population data, since there is no direct patient interaction where an association might be suggested or inferred.
Nevertheless, if aggregate or epidemiologic analyses suggest that an AE is associated with exposure to a drug or medical product, it is desirable that the minimum dataset information be forwarded to the manufacturer of the product, who will determine any need for, and timing of, reporting of study results to the relevant regulatory authorities.
Figure 12—1 Best practices for adverse event reporting to FDA by registries of postmarket products. Some registries also collect and record AEs reported directly by the patients or their caregivers.
It is important to develop a plan for detecting, processing, and reporting AEs for any registry that has direct patient contact. If the registry receives sponsorship in whole or part from a regulated industry for drugs or devicesthe sponsor has mandated reporting requirements, including stringent timelines.
AE reporting requirements for registry sponsors are discussed later in this chapter. Prior to registry launch, the process for detecting and reporting AEs should be established in collaboration with the sponsor and any oversight committees. AE reporting is based on categorization of the AE according to the seriousness of the event, its expectedness based on product labeling, and presumed causality or possible association with use of the product, as follows: Serious AEs SAEs include events that result in death, are life threatening an event in which the patient was at risk of death at the time of the eventrequire or prolong inpatient hospitalization, result in persistent or significant disability or incapacity, or result in a congenital anomaly.
Important medical events may also be considered serious when, based on medical judgment, they may jeopardize the person exposed and may require medical or surgical intervention to prevent one of the outcomes listed above e.
Determination of expectedness is made by the sponsor on a case-by-case basis.
Expected events typically do not require expedited reporting to the regulatory authorities. Relatedness is a term intended to indicate that a determination has been made that the event had a reasonable possibility of being related to exposure to the product.
This assessment of causality may be based on factors such as biological plausibility, prior experience with the product, and temporal relationship between product exposure and onset of the event, as well as dechallenge discontinuation of the product to determine if the AE resolves and rechallenge reintroduction of the product to determine if the AE recurs.
Many terms and scales are used to describe the degree of causality, including terms such as certainly, definitely, probably, possibly, or likely related or not related, but there is no standard nomenclature.What the students are learning is a process of problem definition (and each case has multiple problems, some important and some partly important and some unimportant), assembly of information and data, analysis and evaluation, formulating actions or policies or decisions, and selecting a course of action.
AES Case AES Corporation historically used a very simple method that was used for all projects being examined, regardless of geographical location. The method worked well when implemented in the U.S., but when it began to be used to evaluate international projects, it was giving the company false.
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