Post-Marketing Surveillance

The goal of the Center for Drug Evaluation and Research’s (CDER) Post-Marketing Surveillance (PMS) system is to monitor the ongoing safety of marketed drugs. This is accomplished by reassessing drug risks based on new data learned after the drug is marketed, and recommending ways of trying to most appropriately manage that risk. This is done through a variety of activities and tools that are outlined below. This work is accomplished primarily through CDER's Division of Pharmacovigilance and Epidemiology.

• PMS Information Sources Chart - Provides an overview of the various drug experience and epidemiologic sources available to CDER in conducting surveillance and risk assessment of marketed drugs
• MEDWatch- a description of FDA's medical product reporting program
• Spontaneous Reporting System - For monitoring Adverse Drug Reaction Reports
• Pharmacoepidemiology - Efforts of CDER's epidemiology staff in monitoring drug safety
• Contracts/Cooperative Agreements - These provide important drug safety data on a national level

Medication errors cause at least one death every day and injure approximately 1.3 million people annually in the United States. Medication mishaps can occur anywhere in the distribution system:

• Prescribing
• Repackaging
• Dispensing
• Administering
• Monitoring

Common causes of such errors include:

• Poor communication,
• Ambiguities in product names, directions for use, medical abbreviations or writing,
• Poor procedures or techniques, or
• Patient misuse because of poor understanding of the directions for use of the product.

In addition, job stress, lack of product knowledge or training, or similar labeling or packaging of a product may be the cause of, or contribute to, an actual or potential error. CDER responsibilities are not completed when the safety and effectiveness of a drug product are determined. The Center also has the responsibility for helping to ensure the safe use of the drugs it approves by identifying and avoiding proprietary names that contribute to problems in the prescribing, dispensing, or administration of the product. Because early identification of a potential confusing proprietary name is crucial, CDER reviews these proposed names, prior to approval of a new drug application, by means of the Office of Postmarketing Drug Risk Assessment (OPDRA).

CDER's approach to medication errors is as follows:

• Prevent medication errors prior to a drug's approval
• After approval, evaluate, monitor, and take appropriate action on reports of medication errors
• Educate and provide feedback to health professionals
• Share information with outside organizations involved in preventing medication errors

Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority.

Class I recall - situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Class II recall - situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Class III recall - situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

If the FDA determines that a company is marketing a product in a way that conflicts with its official, approved, labeling (sometimes called the Package Insert), they issue a warning letter to the company involved. It is a serious notice to an investigator/company and demands development of effective corrective actions, with the threat of legal penalties if the actions are not impending. Serious repeat violators may be banned by the FDA from performing clinical research on FDA-regulated products. Additionally, the data from any clinical investigator’s site could be rejected from consideration in the FDA submission it is intended to support. Approximately two weeks after the warning letter is sent to the company, a copy of the warning letter is posted to the FDA website.

To search through the FDA database of Warning Letters go to: www.fda.gov/foi/warning.htm