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CDER 2007 Update
Drug Safety Surveillance
We evaluate the safety of drugs available to American consumers using a variety of tools and disciplines. We maintain a system of post-marketing surveillance and risk assessment programs to identify adverse events that did not appear during the drug development process. We monitor adverse events such as adverse drug reactions, drug-drug interactions and medication errors.
We have access to commercial databases that contain non-patient-identifiable information on the actual use of marketed prescription drugs in adults and children. These resources augment our ability to determine the public health significance of adverse event reports.
As we discover new knowledge about a drug’s safety profile, we make risk assessments and decisions about the most appropriate way to manage any new risk or new perspective on a previously known risk. Risk management methods may include new labeling, drug names, packaging, “Dear Health Care Practitioner” letters, education or special risk communications, restricted distribution programs or product marketing termination.
Population-based drug safety evaluation
We have established several contracts that give us access to population-based data resources. This enables us to evaluate the use and safety of newly marketed drugs in real world settings. The databases we work with provide healthcare data on more than 20 million persons in the United States in different geographic areas and include special populations, such as children and pregnant women. We also work with a database from the United Kingdom that provides electronic medical record data on nearly 10 million persons receiving their health care from a general practitioner.
We use these databases to:
- Evaluate the extent of drug exposure in the population and the levels of potential risk that may be associated with that exposure.
- Provide a mechanism for collaborative investigations to test hypotheses, particularly those arising from suspected adverse reactions reported to us.
- Enable our rapid access to U.S. population-based data sources to examine patterns of care and their impact on the safe use of drugs.
CDER is developing a guidance on best practices for pharmacoepidemiologic studies of drug safety issues using electronic healthcare data. FDA entered into collaborations with the Veterans Health Administration, the Centers for Medicaid & Medicare, and the Agency for Health Care Research Quality to enable access to their large databases to look at drug effects and evaluate drug safety signals.
Data mining
Our safety evaluators and epidemiologists routinely use data mining software for quantitative analysis of drug safety data. Using data mining for drug-event signal generation increases our awareness and understanding of trends and patterns in adverse drug reactions. In 2007, CDER began a pilot project between Office of Surveillance and Epidemiology and Office of New Drug’s Division of Cardiovascular and Renal Products to increase post-marketing data mining surveillance of all products within this division.
Adverse Event Reporting System
A powerful drug safety tool is the Adverse Event Reporting System, known as AERS. This computerized system combines the voluntary adverse drug reaction reports from MedWatch and the required reports from manufacturers. These reports can often be signals that there may be a potential for serious and unrecognized drug-associated events. When a signal is detected, further testing of the hypothesis is undertaken using various epidemiological and analytic databases, previously published studies or other instruments and resources. AERS features both paper and electronic submission options with international compatibility.
In 2007, we received 482,155 reports of suspected drug-related adverse events from the MedWatch program and from the postmarketing 15-day and periodic safety reports submitted by manufacturers:
- 23,033 MedWatch reports directly from health-care providers and consumers.
- 230, 922 manufacturer 15-day reports for adverse events that are both serious and unexpected (not in the approved labeling).
- 228,200 manufacturer periodic reports for adverse events that are both serious and expected or non-serious.
Accessible text.
Report types
- Direct reports to MedWatch. An individual, usually a health-care practitioner, notifies us directly of a suspected serious adverse event.
- 15-day (expedited) reports. Manufacturers report adverse events that are both serious and unexpected as soon as possible but within 15 days of discovering the problem.
- Manufacturer periodic reports. These report all other adverse events, such as those that are not serious and that are already described in the product’s labeling. These reports are submitted quarterly for the first three years of marketing and annually there after.
Adverse event electronic submissions
Electronic submission of adverse event reports permits more timely receipt and evaluation at a considerable cost savings for both the FDA and industry. In late 2007, 40 sponsors submitted their 15-day reports electronically, and 11 submitted periodic adverse event reports electronically.
Since electronic submissions began in 2000 for 15-day reports and in 2001 for periodic reports, the number of electronic submissions has grown tremendously each year. Our initiative to encourage electronic reporting continues to make progress and remains a high priority.
We provide useful information on electronic adverse event reports at http://www.fda.gov/cder/aerssub/default.htm.
MedWatch
Safety Information and Voluntary Adverse Event Reporting
We administer the MedWatch program that helps promote the safe use of drugs by:
- Rapidly disseminating new safety information on the internet and providing e-mail listserve and RSS feed notification to health professionals, institutions, the public and our MedWatch partner organizations, consisting of professional societies, health agencies and patient and consumer groups.
- Providing a mechanism for health professionals and the public to voluntarily report serious adverse events, product quality problems, medication use errors and therapeutic failure and inequivalence for CDER-regulated drugs and therapeutic biologics. Reports can be filed by mail, fax, telephone or online at www.fda.gov/medwatch/report.htm.
- Educating health professionals― both practitioners and students― and consumers about the importance of recognizing and reporting serious adverse events and product problems, including medication errors. Our education program includes Internet outreach, speeches, articles and exhibits. We also offer a video self-learning module, "FDA MedWatch and Patient Safety", at: www.connectlive.com/events/fdamedwatch/
Individual health-care professionals and consumers can sign up for our GovDelivery
e-mail notification service, which now has over 92,000 subscribers. We also have 160 MedWatch partner organizations who work with MedWatch to promote FDA's drug safety program. In 2007, these individuals and groups received:
- 102 safety alerts for drugs and therapeutic biologics.
- 25 to 70 safety-related labeling changes for drugs each month, these include important changes to boxed warnings, warnings, contraindications, precautions and adverse reaction sections, and new or updated patient labeling information, medication guides and patient package inserts.
Medication Error Prevention
We review proposed brand names, labels, labeling and packaging to help prevent medication errors in prescribing, dispensing or administering drug products. To ensure the safe use of drugs we avoid brand names that look or sound like the name of existing products.
We review about 2,000 post-marketing reports of medication errors each month. About half are due to error-prone labeling such as similar looking labels and labeling, poor package design, confusing instructions for use and confusing names. We investigate the causes and contributing factors of these errors and recommend revisions to the label, labeling and/or packaging of these products to avert further error.
In January 2007, we conducted a public workshop to explore how labels on intravenous drug products could be designed to minimize medication errors and to define the limitations faced by the different stakeholders. The workshop was an opportunity to hear from all stakeholders in order to gain a better understanding of the medication error issues they face and the challenges they have in making changes to improve patient safety.
Drug Shortages
We work to help prevent or alleviate shortages of medically necessary drug products. Drug shortages occur for a variety of reasons including manufacturing difficulties, bulk supplier problems and corporate decisions to discontinue drugs.
Because drug shortages can have significant public health consequences, we work with all parties involved to make sure all medically necessary products are available within the United States.
Drug shortage program aids counterterrorism effort
Utilizing data obtained from manufacturers and distributors, our drug shortage program provides supply and production information in response to federal government requests in relation to counterterrorism efforts.
We have a Web site that lists current drug shortages, describes efforts to resolve them and explains how to report them. The site is at www.fda.gov/cder/drug/shortages. We have an e-mail address to provide the public a communication tool for drug shortage information at DrugShortages@cder.fda.gov.
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Date created: July 31, 2008 |
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