Frequently Asked Questions

QUESTIONS ABOUT ADVERSE EVENTS AND THE FDA

Q: What is an adverse event?

A: An adverse event is an unwanted side effect associated with the use of a medication (drug) or medical product. Commonly known as “side effects”, adverse drug events occur when a patient experiences a negative reaction while taking one or more medications at the prescribed dosage directed by a healthcare provider.

Q: How are adverse events reported to the U.S. Food and Drug Administration (FDA)?

A: Adverse events must be reported to the FDA by the manufacturer and can be reported voluntarily to the FDA by providers and consumers. Reports submitted to the products’ manufacturers are then forwarded to the FDA as required by regulations. More often, patients report the problem to their physician, who then reports the information to the manufacturer.

Q: What does the FDA do with this data?

A: The FDA collects adverse drug events information from reports submitted by consumers, healthcare providers, and manufacturers into a collective database that is difficult to access, incomplete and only updated once a quarter. Given the fragmented and voluntary process of FDA adverse events reporting, the information in regards to harmful medication side effects can be inaccurate and time-delayed.

Q: How are adverse events with prescription drugs impacting the U.S. patient population?

A: Patients are now taking more prescription medications than ever. A reported 48 percent of the U.S. population took one prescription drug and 21 percent took three or more prescription drugs during the course of one month. The growing trend of patients relying on more than one medication increases the potential risk for harmful adverse events. Only 500,000 adverse drug events are reported to the FDA, estimated to be less than 10 percent of actual adverse events1.

The Institute of Medicine (IOM) estimates that approximately 9.3 percent of adverse drug events result in patient deaths and nearly 24 percent require hospitalizations2.

Q: What is the FDA’s Adverse Event Reporting System (AERS)?

A: The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA's drug safety surveillance program for FDA approved prescription medications. The AERS is a centralized database that includes information from voluntary reports from providers and consumers, along with mandatory reports from manufacturers in regards to medication interactions and adverse events. The medication interactions information collected by the FDA can be unreliable, sporadic and outdated. In fact, it is estimated that less than 10 percent of all adverse events are being recorded into AERS1.

The standardization of drug names, conditions treated and the nature of adverse events listed within AERS is also a challenge. For example, there are misclassifications of the approximately 6,000 FDA approved medications into over 200,000 separately identified drugs in AERS; with each drug listed by its brand, generic, foreign or misspelled name listed in the adverse event report. It is not unusual for a single branded drug to be identified by over 100 different names within AERS. Similar problems exist for the conditions treated and the adverse event descriptions, making it very difficult to identify all adverse events reported to the FDA associated with a particular medication.

Q: How is AERS used within the healthcare industry?

A: As the sole government resource for adverse drug events information in the U.S., the $835 billion drug industry uses AERS to guide economic and care decisions within the healthcare industry. The FDA relies on AERS to inform approval and labeling decisions and monitor for new medication interactions and medication errors. In addition, AERS data guides product and business development decisions by pharmaceutical companies, formulary and coverage decisions by insurance companies, treatment decisions by healthcare providers, investment decisions by healthcare investors and medication decisions by patients.

Q: What is the economic impact of the market segments within the healthcare industry that rely on AERS data?

A: The healthcare industry relies on AERS data to inform significant business and financial decisions. These decisions impact the following sectors within the healthcare industry:
Pharmaceutical and Biotech: This sector generates $835 billion globally and $320 billion domestically in annual drug sales, estimated to grow to $1.1 trillion by 20143.
Managed Care and Healthcare Insurance: This $465 billion industry generates over $15 billion in profits annually4. Over 1,000 companies in the managed care sector are largely responsible for purchasing the $835 billion in drug sales.
Healthcare Systems and Hospitals: The top ten healthcare providers are estimated to generate over $135 billion in patient revenue annually5. The hospital formularies and medications prescribed for their patients are largely dependent on drug safety information.
Healthcare Investment Community: More than 500 firms manage over $300 billion in healthcare funds6. AERS is used to calculate risk by identifying potential revenue trends in portfolio companies and identify market volatility from pending regulatory actions in the pharmaceutical industry.

AERS is used to calculate risk by identifying potential revenue trends in portfolio companies and identify market volatility from pending regulatory actions in the pharmaceutical industry.

Q: Is the FDA AERS data reliable?

A: AERS data have limitations, however, analysis of such data is the only way to conduct a wide reaching review of post-marketing adverse events linked to FDA approved drugs. AERS is utilized by the US government to monitor the safety of FDA approved medications.

Excerpted from the FDA's website: "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 E2B ) issued by the International Conference on Harmonisation. AERS is a useful tool for FDA, which uses it for activities such as looking for new safety concerns that might be related to a marketed product....Based on an evaluation of the potential safety concern, FDA may take regulatory action(s) to improve product safety and protect the public health, such as 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."

QUESTIONS ABOUT ADVERSEEVENTS INC.

Q: Who is AdverseEvents, Inc. (AEI)?

A: AdverseEvents, Inc. (AEI) is the first service provider to deliver accurate, real-time information on adverse drug events reported to the FDA. AEI utilizes a unique data method called RxFilter™ , a proprietary 17-step data refinement process that standardizes and normalizes data from the FDA’s Adverse Event Reporting System (AERS) into a user-friendly, fully searchable, database of over 5,900 approved medications. Over 500,000 medication adverse events are reported yearly to the FDA; estimated to be only 10% of all actual adverse events. As a leading resource for the pharmaceutical industry, AEI supports companies with competitive intelligence and data to inform drug marketing decisions and business development strategies. With AEI, the healthcare industry is able to quantify the benefit-risk assessments of FDA approved drugs to fully understand the scope of safety issues, based on accurate rates of side effects from such medications.

Q: How does AdverseEvents improve patient safety?

A: AdverseEvents utilizes a data sourcing method called RxFilter™ , providing precise, standardized solutions for an accurate view of drugs safety issues reported to the FDA. RxFilter is a proprietary 17-step data refinement process developed by AdverseEvents, Inc. that standardizes and normalizes the AERS database. Combining complex computer algorithms with hands-on data analysis by highly trained researchers, the RxFilter process is the most thorough optimization procedure ever applied to the FDA's drug safety database to accurately measure and track adverse events associated with medications reported to the FDA.

Through RxFilter’s refinement of information gaps in the FDA’s database, AEI’s reporting tools and solutions improve patient care by providing pharmaceutical companies with unparalleled drug safety data on which to base business and clinical development decisions. AEI also offers physicians reliable, accessible drug adverse events information to support clinical decisions at the point of care. With AEI, providers are able to quantify the benefit-risk assessments of FDA approved drugs and clearly understand the scope of safety issues and side effect trends in order to maximize patient safety.

AEI also improves patient safety by empowering the consumer with accurate, user-friendly medical information. AdverseEvent’s refined FDA dataset is also available online for direct consumer access. Therefore, consumers have the ability to submit their own adverse drug events data to AdverseEvents and have free access to medication side effects information. The data collected from consumers will bolster the value of AdverseEvents’ reporting tools and solutions available online, further enhancing the information on adverse drug events reported to the FDA, reflecting a more precise portrayal of potential side effects associated with a prescription medication. Patients can access these tools at http://www.adverseevents.com.

Q: What makes AEI unique from other online adverse event drug resources?

A: AEI'’s database is the only resource that utilizes the RxFilter process to combine all the varied designations for a medication found in AERS into a single name and standardizes the AERS database for improved accuracy of adverse drug event information, dramatically improving search functionality for side effect information and data analysis. In addition, AEI offers a unique resource that targets the broad healthcare industry, including providers, consumers and manufacturers, offering detailed case study reports relevant industrywide for accurate, drug side effect trends analysis.

Q: Who has access to AEI's data?

A: AEI's basic data is available to the general consumer for free. For advanced searching, alerts and the AdverseEvents Monitor Reports a premium subscription is required. Our client base includes, but is not limited to, pharmaceutical, insurance, financial, medical organizations and academic institutions.

Q: What does AEI provide that the FDA AERS data does not?

A: The FDA AERS database is unstructured, not easily searchable, and not standardized. AEI's RxFilter process has resulted in a clean, easy-to-read database for both health-care professionals and patients. RxFilter is a proprietary 17-step data refinement process developed to standardize and normalize the AERS database. Combining complex computer algorithms with hands-on data analysis by highly trained researchers, the RxFilter process is the most thorough optimization procedure ever applied to the FDA's drug safety database to accurately measure and track adverse events associated with medications reported to the FDA.

Q: What are the solutions AdverseEvents provides for healthcare professionals?

A: Healthcare professionals will have access to online advanced searching and reporting tools for all FDA approved medications. Qualitative analysis reports on FDA approved drug safety trends are also available, helping providers track medication trends based on accurate, refined, standardized AERS information to best inform clinical decisions for their patients. To access these tools, please visit http://www.adverseevents.com.

Q: What are the solutions AdverseEvents provides for pharmaceutical industry professionals?

A: Pharmaceutical industry professionals need access to reliable, real time drug safety data to identify new drug safety issues immediately, shape business development decisions, understand the scope of safety issues and side effect trends, survey the competitive landscape with detailed views into competing drug product lines, and utilize real time data to direct business and financial decisions. AEI offers the pharmaceutical industry a unique resource to achieve these goals to ensure high quality standards for their medications to protect patient safety.

QUESTIONS ABOUT ADVERSEEVENTS’ MONITOR REPORTS

Q: Is AdverseEvents Inc., sponsored or paid by a drug company to produce reports?

A: AdverseEvents Inc., (AEI) is an independent company not associated with the manufacturing, promotion or selling of drugs. AEI is a for profit company that generates income by providing FDA AERS data that has been normalized and standardized via its RxFilterTM, rendering it easily searchable and accessible. AEI, however, has not been compensated, directly or indirectly, by any third party for the preparation of any of its Monitor reports.

Q: How does AEI support the Monitor Report findings?

A: AEI does not conduct clinical trials. AEI's sole purpose is to highlight trends and drug safety information that were not previously available. AEI accomplishes this by converting postmarketing adverse event information from the FDA AERS database into a user-friendly and easily-searchable format. The Monitor Reports are produced as a public health service designed to highlight safety findings regarding popular drug classes. The Monitor Reports encourage and recommend further research and analysis in order to clarify side effect data contained within the FDA AERS reporting system.

Q: Does AEI champion the removal of products from the public market?

A: AdverseEvents mission is to supply access to unbiased drug side effect data for FDA approved drugs. The public data that we process through our RxFilter produces information on adverse event reporting trends. AEI Monitor Reports and associated data are meant to encourage open conversations regarding further analysis by both pharmaceutical companies and researchers. We believe that the more information available, the better the conversation, and therefore, the safer the public. There is no better way to determine the safety of a drug than by reviewing all the information available - from pre- to post-marketing. AEI believes that it would be irresponsible, having access to all the data and results that we do, to not openly share them publicly for further debate, discussion, and study.

Q: How can AEI's rankings of drug' vis-a-vis their adverse events be accurate when AERS data has notable limitations?

A: Any rankings are based on the adverse events gathered in the FDA AERS system. As with all aspects related to human health, no one element should be consider on its own, but instead as a vital component in the overall picture. AERS limitations should always be considered when reviewing our data and reports. We always recommend further analysis to the pharmaceutical and medical communities and stress that consumers must have a consultation with their prescribing physician before taking any action that relates to data supplied in our reports.

Q: How to you counter the argument that all AE reporting is heavily influenced by physician expectations/differential reporting/poor reporting?

A: Excerpted from the FDA Website -- "AERS data do have limitations. First, there is no certainty that the reported event was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. Further, FDA does not receive all adverse event reports that occur with a product. Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event. Therefore, AERS cannot be used to calculate the incidence of an adverse event in the U.S. population."

That said, the US Government and the medical and pharmaceutical industries look to AERS data as both a guide and indicator of drug safety issues. Prescription drugs routinely have their warning labels changed and/or are removed from the US drug market after the incidence, or severity, of their side effects is determined to differ from what there clinical trial testing phases suggested. Controlled clinical trials cannot accurately predict the magnitude and scope of side effects once a drug is released into large consumer populations. The AERS system is the only current way to capture these valuable data. We understand that these are a new type of data and that there may be objections to their predictive utility. However, with more information becoming available from more sources, and the wider availability of direct patient side effect and outcome reporting, we believe that these types of data are only going to become more prevalent and relevant.

1United States General Accounting Office. Testimony Before the Committee on Health, Education, Labor, and Pensions, U.S. Senate. \"Adverse Drug Events: Substantial Problem but Magnitude Uncertain\" http://www.gao.gov/new.items/he00053t.pdf
2 Committee on Quality Health Care in America. Institute of Medicine (IOM). To err is human: building a safer health system. Washington, D.C: National Academy Press. 2002.
3 IMS Health, Market Prognosis, 2010, April 2010 http://bit.ly/h59YbF
4 KPMG, 2010 Managed Care Industry Report, May 2010 http://bit.ly/gf3n3W
5 Modern Healthcare, Modern Healthcare’s 33rd Annual Hospital Systems Survey, June 8, 2009 http://bit.ly/1IZRLm
6 BigDough, http://www.bigdough.com