EudraVigilance. URL: http://www.eudravigilance.org. This Web site provides useful background information on the pan-European pharmacovigilance system for ongoing monitoring of drug adverse effects. The EudraVigilance database compiles individual case safety reports related to medicinal products authorized for marketing under the EU's Centralized Registration scheme. This collection is accessible only to designated regulatory authorities and selected personnel in pharmaceutical companies. The latter may search and view only adverse effect data related to their own products.
EU Public Safety Reports and Marketing Authorization Withdrawals or Suspensions are accessible at the EMEA Web Site, annotated in greater detail later in this chapter.
MedWatch. URL: http://www.fda.gov/medwatch/index.html. The FDA's MedWatch Web site outlines procedures for voluntary reporting of serious adverse events or product problems by consumers and healthcare practitioners. It also includes a small database of Public Safety Alerts (1996 forward) related to specific drugs, biologies, devices, and dietary supplements. A separate index, updated monthly, provides access to all safety-related drug labeling changes retrospective to 1996. Searchable by product brand name, labeling records show specific additions and deletions initiated to clarify indications and precautions.
DIOGENES®: Adverse Drug Events Database. 1969-. Gaithersburg, MD: FOI Services. Quarterly. Legally mandated adverse event reporting to the FDA began in 1969, when data from manufacturers and distributors were entered into the government agency's ADR system. Original reports varied greatly in the amount of detail provided, and many included only minimal information. In November 1997, a new Adverse Event Reporting System (AERS) succeeded the ADR database as a repository for more consistent and detailed information gathered through a redesigned MedWatch submission form. Searchable data elements include drug name, reaction date, FDA receipt date, manufacturer name, dosage and route of administration, concomitantly administered drugs, patient age and gender, and reported reactions and outcomes. Information gathered through the MedWatch program originates from both mandated reports submitted by pharmaceutical companies about their own marketed products and from voluntary reports relayed by healthcare professionals and consumers. The DIOGENES: Adverse Drug Events Database compiles both ADR and AERS records in a single, integrated file for online searching.
FDA Enforcement Report Index. 1990- . Weekly. URL: http:// www.fda.gov/opacom/Enforce.html. This database provides access to drug and medical device recalls and product seizures in the United States. A search form incorporated into the opening page enables keyword searches of the entire collection. Simple queries involving only one factor, such as a company or brand name, quickly locate pertinent recall notices, each of which identifies specific product batches, quantities withdrawn from commerce, and their previous geographic distribution. Each entry also describes the reason for recall (contamination, subpotency, mislabeling, etc.) and the FDA classification of the severity of the problem (I, II, or III, where class I indicates a potentially life-threatening error or risk of serious damage). Unfortunately, search queries that require coordination of more than one factor (such as company name and "class I'') retrieve references to entire issues of the FDA Enforcement Report where both terms occur—rather than individual recall notices, where their colocation would be relevant.
Other searchable sources of FDA recall data are DIOGENES: FDA Regulatory Updates (1984 forward) and F-D-C Reports (1988 forward). Because both of these commercial databases create separate online records for each recall notice, results from searches that involve coordination of multiple factors (e.g., company name + recall class of severity) are more precise than those retrieved using the FDA Web site's search engine.
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