Review on Adverse Event Reporting System
by
Developed by: Sarmistha Mahapatra
Reviewed by: Lanka Srinivas
Introduction
Adverse event reporting system is basically a database that is designed to support the US FDA’s post marketing surveillance program. This database contains a pool of information on adverse events and medication reports that are submitted to the FDA. The FDA uses AERS to monitor for new adverse events and medication errors that might occur with these marketed products. The structure of AERS is in compliance with the international safety reporting guidance (ICH E2B2) issued by the International Conference on Harmonization while the Adverse events in AERS are coded according to the terms in the Medical Dictionary for Regulatory Activities terminology (MedDRA).
Adverse event reporting in US though is not mandatory, however healthcare professionals, pharmaceutical companies and consumers may report the adverse events directly to the FDA. The MedWatch site provides information about voluntary and mandatory reporting. This reports received by the FDA are then evaluated by clinical reviewers in the centre for drug evaluation and Research (CDER) and the center for biologics Evaluation and Research (CBER) , which are used to monitor the product’s safety profile. On the basis of these evaluation , FDA may take regulatory action(s) to improve the product’s safety profile by either updating a product’s labeling information, restricting the use of the drug, communicating new safety information to the public, or, in rare cases, removing a product from the market , thereby ensuring the safety of the people.
The main purpose of setting up an adverse event reporting system is to refine the drug having least toxicity, as the increased number of reports would lead to analysis of the product characteristics which would indirectly help us to improve the product more thus ensuring the total safety to people. Besides this, it would also create an increased awareness among people about the product they are consuming.
Adverse Event Reporting system Requirements:
The three basic and quite essential parameters for maintenance of any ADR system are:
Collection: This involves the collection of adverse events occurring worldwide through various reliable sources such as marketing authorization holders, healthcare professionals, consumers, international/public bodies, journals, published and updated literature, etc.
Analysis and Classification:
All the collected information need to be analyzed and classified appropriately.
Circulation: This analyzed information now has to be circulated among the all the health care practitioners, Marketing authorization Holders ,for creating awareness about the benefit/risk characteristic of the product.
Contents of Adverse Event report:
While reporting an adverse event to any databases or forms , the adverse event report should cover these four factors:- Patient Drug Adverse event. Composer/reporter of the report.
Types of Reports:
Learning systems
Reporting to learning systems is usually voluntary, and typically spans a wider scope of reportable events than the defined set of events typically required by a mandatory system. Rather than assure a minimum standard of care, learning systems are designed to foster continuous improvements in care delivery by identifying themes, reducing variation, facilitating the sharing of best practices, and stimulating system-wide improvements. Following careful expert analysis of underlying causes, recommendations are made for system redesign to improve performance and reduce errors and injuries.
In Australia, for example, over 200 health-care organizations or health services voluntarily send incident reports to the Australian Incident Monitoring System (AIMS) sponsored by the Australia Patient Safety Foundation (APSF). AIMS uses the Healthcare Incident Types (HIT) classification system, which elicits very detailed information from the reporter regarding generic incident types, contributing factors, outcomes, actions, and consequences. The Japan Council for Quality Health Care collects voluntarily reported adverse events from health-care organizations in Japan, particularly sentinel cases with root cause analysis. A research team led by Tokai University asks health-care organizations to voluntarily pool their events, which are then aggregated and results disseminated. In 2003, the Ministry of Health, Labour and Welfare patient safety committee recommended a national reporting system. The National Reporting and Learning System (NRLS) in England and Wales is another example of a learning system. NRLS receives reports of patient safety incidents from local health-care organizations.
Accountability systems
Reporting in accountability systems is usually mandatory and restricted to a list of defined serious events (also called “sentinel” events) such as unexpected death,transfusion reaction, and surgery on the wrong body part. Accountability systems typically prompt improvements by requiring an investigation and systems analysis (“root cause analysis”) of the event. Few regulatory agencies have the resources to perform external investigations of more than a small fraction of reported events, however, which limits their capacity to learn. In Slovenia, a brief description of a sentinel event must be sent to the Ministry of Health within 48 hours, and 45 days later a satisfactory analysis with corrective actions must be submitted or else a follow-up consultation with the Ministry occurs. The Czech Republic has reporting requirements that follow from their accreditation standards. The Netherlands has a two-tiered process. The Health Care Inspectorate, the agency accountable for taking actions against substandard performance, mandates hospitals to report adverse events that have led to death or permanent impairment. Other adverse events are reported voluntarily. There is interest in moving towards a more uniform blame-free reporting system to aggregate events nationally. A number of states in the United States have reporting systems that require hospitals or other providers to report certain types of serious, usually preventable events.
Most accountability systems not only hold health-care organizations accountable by requiring that serious mishaps be reported, they provide disincentives to unsafe care through citations, penalties or sanctions. The effectiveness of these systems depends on the ability of the agency to induce health-care organizations to report serious events and to conduct thorough investigations. Accountability systems can (and should) be learning systems if investigations are carried out and if the lessons learned are disseminated to all other providers by the agency. For example, the Danish Health Care System recently passed an Act on Patient Safety that requires health-care providers to report adverse events so information can be shared and aggregated for quality improvement.
Confidentiality and public access to data
Experience has shown that learning systems are most successful when reports are confidential and reporters do not feel at risk in sharing information about errors. Indeed,some feel it is only with such safe reporting systems that subtle system issues and the multitude of contributing factors will be uncovered. From a pragmatic standpoint, many believe that protecting the confidentiality of health-care organizations significantly enhances participation in reporting.
However, some citizen advocacy groups have called for public disclosure of information uncovered during investigations of serious adverse events, asserting the Public’s right to know about these events. Surveys in the United States show that 62–73% of Americans believe that health-care providers should be required to make this information publicly available. Nonetheless, all but three states in the United States have statutes that provide legal protection of confidentiality.
Internal reporting
Reports to an agency or other national body from a hospital or other health-care organization usually originate from a report within the institution. While such report say merely reflect statutory requirements, an institution that values patient safety will have an internal reporting system that captures much more than that. The objectives of an internal reporting system for learning are first, to identify errors and hazards, and then through investigation to uncover the underlying systems failures, with the goal of redesigning systems to reduce the likelihood of patient injury. The key conceptual point here, and the heart of a non-punitive approach to error reporting, is the recognition that adverse events and errors are symptoms of defective systems, not defects themselves. Reporting, whether retrospective (adverse events and errors) or prospective (“hazards”, or “errors are waiting to happen”) provides the entry point into investigation and analysis of system’s defects which, if skillfully done, can lead to substantial system improvements. Reporting is one way to get this type of information, but not the only way. Ideally, internal reporting systems should go hand in hand with external reporting systems, by identifying and analyzing events that warrant forwarding to external reporting agencies. Conversely, external reporting systems are most effective when they are an extension of internal systems.
Current Adverse Event Reporting Systems
Currently the adverse events are reported by health care providers, consumers and pharmaceutical companies. Sometimes the consumers report to the pharmaceutical companies which then the company reports to the FDA. There are several databases which allow the reporting of adverse events such as FDA’s Medwatch online reporting and several commercial softwares and databases such as oracle’s Adverse Event Reporting System have been developed for reporting adverse events along with benefit/risk assessment of the concerned product. Oracle’s AERS not only are the single source of adverse event , they even produce regulatory reports from standard templates for regulations like Medwatch 3500a, CIOMS I, NDA Periodic, PSUR, IND Safety Update, Yellow Card, BfArM, Medwatch for Device, VAERS etc. They even monitor safety issues and incidents over time using audit trail and product tracking, however apart from sophisticated softwares there are simple databases which a lay man could even enter any adverse events he has experienced apart from the health care practitioners such as FDA’s Medwatch form 3500A, Please report all significant adverse events that occur after vaccination of adults and children, even if you are not sure whether the vaccine caused the adverse event. VAERS, software, which allows online reporting of all significant adverse events that occur after vaccination of adults and children, even if the reporter is unsure whether the vaccine has caused the adverse event.
Reporting adverse events to institutional review boards and other independent boards
Current systems for reporting adverse events to institutional review boards (IRBs) are a bit messy and problematic because these reports do not contain the complete information and even these reports are very hard to be analysed since they are unsystematic. Apart from this, FDA has limited authority over the IRB s, however to address these issues, Office of Human Research protection (OHRP) created a draft guidance document titled Guidance on Reporting and Reviewing Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others, that contained regulations to assist IRBs, investigators, research institutions, HSS agencies that conduct or sponsor human subjects research, and other interested parties. However more collaborative efforts are needed to improvise the adverse event reporting system.
Other independent boards, such as The Centers for Medicare and Medicaid Services (CMS) maintain a database that collects safety data about medications and medical devices and have even will also be establish Medicare Patient Event Safety Monitoring System that would examine the adverse events in the near future .the basic purpose of this board is to compile the medical data of the patient for the better management of the reimbursement issues.
However we need to focus on a reward based system that shows a distinct safety profile . According to Dr Woods’s proposal drugs that lacked long-term safety data would be clearly identified as such and in this way, physicians could make the appropriate choice of medication with their patients. A fundamental issue would be the design of these safety studies, which under Dr. Wood’s proposal would require FDA approval. In other words, extended exclusivity would be offered only for well-designed studies structured to answer important clinical questions. Another Forum member Robert Califf proposed a clinical trial “light” system, in which new users of drugs would be notified about known drug risks and benefits. The system would indicate that the drug being prescribed had recently been approved but that information concerning both risks and benefits was being developed. Patients would be provided information to report any adverse events and asked to participate in follow-up studies concerning the medication.
Pharmacovigilance Activities in India:
In India CDSCO has initiated the National Pharmacovigilance program under Family Welfare, and Government of India, where the national pharmacovigilance centers would be responsible for coordinating the program. The National Pharmacovigilance Advisory Committee (NPAC) would thereafter monitor the performance of various Zonal Pharmacovigilance Centre(ZPC), Regional Pharmacovigilance Centre(RPC), and peripheral centers and performs the functions of "Review Committee" for this program and would also recommend possible regulatory measures based on pharmacovigilance data received from various centers. The National Centre will operate under the supervision of the NPAC to recommend procedures and guidelines for regulatory interventions.
The National Pharmacovigilance Program (NPP) would operate with some definite objectives that include creating awareness and a sense of responsibility for several healthcare professionals and NGOs in the drug monitoring and information dissemination process. The NPP has the vision to achieve a benchmark for global drug monitoring endeavors.
Periodic Safety Update Reports shall be expected to be submitted every 6 monthly for the first 2 years of marketing in India, and annually for the subsequent 2 years. In addition, training programs and interaction meetings shall be held every 6 months after the initial training. All data generated (including reporting forms) will be stored and preserved for the purpose of archiving for a minimum period of 5 years at the ZPCs. The reporting of seemingly insignificant or common adverse reactions would be important because it may highlight a widespread prescribing problem
New approaches for improving reporting systems
Although there are several reporting systems for collecting adverse events, there is a need of developing highly sensitive and accurate system that would capture the adverse events worldwide. The new methods should be able to capture “high-frequency, high-impact” cases that are not detected with the current systems.
There can be several approaches for improving the current adverse event reporting system such as to have incentives for long-term safety studies.” This, however, would cause a long delay before drug approval and would not be cost-efficient. It would also entail discussion about which drugs would be subject to long-term study. Another approach is to conduct long-term safety studies after approval. This again requires consideration of which drugs would be chosen for study or whether all drugs should be studied. Another way is to ensure the completion of safety studies is to offer extended exclusivity to companies that have acquired data to demonstrate that their drug is safe in the long term. This makes the drug more valuable to consumers and to the company.
References
1.http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/default.htm
2. http://en.wikipedia.org/wiki/Adverse_Event_Reporting_System
3. http://www.drugcite.com/
4. http://www.fdable.com/
5. www.fda.gov/Drugs/InformationOnDrugs/ucm135151.htm
6. www.biotech.com/adverseEventReportSys.php
