What is Post Market Surveillance for Drugs?
What is Post Market Surveillance for Drugs?
What is post market surveillance for drugs?
Postmarketing drug surveillance refers to the monitoring of drugs once they reach the market after clinical trials. It evaluates drugs taken by individuals under a wide range of circumstances over an extended period of time. Such surveillance is much more likely to detect previously unrecognized positive or negative effects that may be associated with a drug. The majority of postmarketing surveillance concern adverse drug reactions (ADRs) monitoring and evaluation.
Other important postmarketing surveillance components include unapproved or off-label drug use, problems with orphan drugs, and lack of paediatric formulations, as well as issues concerning international clinical trials in paediatric population. The process of evaluating and improving the safety of medicines used in paediatric practice is referred to as paediatric pharmacovigilance. It requires special attention. Childhood diseases and disorders may be qualitatively and quantitatively different from their adult equivalents. This may affect either benefit or risk of therapies (or both), with a resulting impact on the risk/benefit balance. In addition, chronic conditions may require chronic treatment and susceptibility to ADRs may change throughout the patient’s lifetime according to age and stage of growth and development. Therefore, paediatric pharmacovigilance aspects need to be tailored to a number of variables based on heterogeneity of paediatric population. This chapter will summarize and discuss the key issues.
The FDA Adverse Event Reporting System (FAERS) is a computerized information database designed to support the FDA’s post-marketing safety surveillance program for all approved drug and therapeutic biologic products. The ultimate goal of FAERS is to improve the public health by providing the best available tools for storing and analyzing safety reports. The reports in FAERS are evaluated by a multidisciplinary staff safety evaluators, epidemiologists and other scientists in the Center for Drug Evaluation and Research’s (CDER) Office of Surveillance and Epidemiology to detect safety signals and to monitor drug safety. As a result, the FDA may take regulatory actions to improve product safety and protect the public health, such as updating a product’s labeling information, sending out a “Dear Health Care Professional” letter, or re-evaluating an approval decision.
The MedWatch program is for health professionals and the public to voluntarily report serious reactions and problems with medical products, such as drugs and medical devices. It also ensures that new safety information is rapidly communicated to the medical community thereby improving patient care. All data contained on the MedWatch form will be entered into the AERS database. The MedWatch page includes sections on how to report an adverse event, safety information, and publications. For more information on how to report adverse events, see Reporting Problems to FDA.
The Division of Drug Marketing, Advertising and Communications page also contains other useful drug advertising and surveillance information.
After a drug is approved and marketed, the FDA uses different mechanisms to assure that firms 1) adhere to the terms and conditions of approval described in the application and 2) that the drug is manufactured in a consistent and controlled manner. This is done by periodic, unannounced inspections of drug production and control facilities by FDA’s field investigators and analysts.
Manufacturers of prescription medical products are required by regulation to submit adverse event reports to the FDA. The MedWatch site provides information on mandatory reporting by manufacturers. In addition, drug manufacturers must submit either error and accident reports or drug quality reports when deviation from current good manufacturing practice regulations occur.
FDA receives medication error reports on marketed human drugs (including prescription drugs, generic drugs, and over-the-counter drugs) and non vaccine biological products and devices. The National Coordinating Council for Medication Error Reporting and Prevention defines a medication error as “any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, healthcare products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.” CDER medication errors program staff review medication error reports sent to the USP-ISMP Medication Errors Reporting Program and MedWatch, evaluate causality, and analyze the data to provide feedback to others at FDA.
Drug Shortages. It is FDA’s policy to attempt to prevent or alleviate shortages of medically necessary products. Drug shortages may arise from varying causes, such as the unavailability of raw materials or packaging components, marketing decisions, and enforcement issues. See the MaPP on Drug Shortage Management (PDF – 78KB) for an overview of CDER’s drug shortage management responsibilities, and how drug shortage reports are processed.
Therapeutic Inequivalence Reporting. In the past 10 years, FDA’s Center for Drug Evaluation and Research has received an increase of reports of drug products that fail to work in patients because the product simply has no effect or is toxic. These problems are usually attributed to switching brands of drugs. As a result, on Sept. 14, 1988, FDA created in CDER the Therapeutic Inequivalence Action Coordinating Committee (TIACC) to identify and evaluate reports of therapeutic failures and toxicity that could indicate that one product is not equivalent to another similar product.
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