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What Students Need To Know About FDA Post Marketing Drug Safety Surveillance

Postmarketing surveillance is the monitoring of drug performance in clinical practice and the taking of appropriate action to improve patient safety. The action taken can range from changes in product labeling (e.g., dose regimen alterations, drug interaction alerts, warnings about previously unknown adverse effects) to product withdrawal from the market. Postmarketing surveillance (PMS) is defined as the identification and collection of information regarding drugs after their approval for use in a population. The drug approval process in some countries is complicated and lengthy, which may hold drugs back from patients in desperate need of them. PMS is a method of systematically monitoring the safety and effectiveness of new drugs in the real world using a variety of patient types with many different comorbid diseases. The population of potential users after a drug is released is very different from the population studied in the premarking phase of a drug’s approval.

Even though clinical trials provide important information on a drug’s efficacy and safety, it is impossible to have complete information about the safety of a drug at the time of approval. Despite the rigorous steps in the process of drug development, limitations exist. Therefore, the true picture of a product’s safety actually evolves over the months and even years that make up a product’s lifetime in the marketplace. FDA reviews reports of problems with prescription and over-the-counter drugs, and can decide to add cautions to the dosage or usage information, as well as other measures for more serious issues. FDA regulates prescription drug advertisements and promotional labeling. By law, a developer is prohibited from advertising unapproved uses of their product.

All advertisements, such as product claims or reminder ads, cannot be false or misleading. They must contain truthful information about a drug’s effectiveness, side effects, and prescribing information. These advertisements can be found in medical journals, newspapers, and magazines, and on the Internet, television, or radio.

Promotional labeling differs from drug advertisements in the way it is distributed. Pharmaceutical companies give out brochures or other promotional materials to physicians or consumers. The drug’s prescribing information must accompany promotional labeling.

New drugs are patent protected when they are approved for marketing. This means that only the sponsor has the right to market the drug exclusively. Once the patent expires, other drug manufacturers can develop the drug, which will be known as a generic version of the drug. Generic drugs are comparable to brand name drugs and must have the same:

  • Dosage form
  • Strength
  • Safety
  • Quality
  • Performance characteristics
  • Intended use

Because generic drugs are comparable to drugs already on the market, generic drug manufacturers do not have to conduct clinical trials to demonstrate that their product is safe and effective. Instead, they conduct bio-equivalence studies and file an Abbreviated New Drug Application.

FDA has several programs that allow manufacturers, health professionals, and consumers to report problems associated with approved drugs.

  • MedWatch is a gateway for reporting problems with medical products (drugs and devices) and learning about new safety information. You can subscribe to regular MedWatch safety alerts.
  • Medical Product Safety Network (MedSun) monitors the safety and effectiveness of medical devices. FDA recruits 350 healthcare providers throughout the United States to report any medical device problems that result in serious injury or death. Each month, FDA publishes the MedSun newsletter. The newsletter gives consumers important information about medical device safety.

Under the Sentinel Initiative, FDA is developing a new national system to more quickly spot possible safety issues. The system will use very large existing electronic health databases—like electronic health records systems, administrative and insurance claims databases, and registries—to keep an eye on the safety of approved medical products in real time.

FDA assesses several data sources including:

  • The product’s pre-approval safety profile
  • The product’s current FDA-approved label
  • Reports made to the FDA Adverse Event Reporting System (FAERS), previously known as AERS
  • Reports made to the Vaccine Adverse Event Reporting System (VAERS)
  • Manufacturer-submitted periodic safety reports
  • Medical literature
  • Drug utilization databases
  • Data from post-approval clinical trials and other studies, when applicable

Postmarketing surveillance data focus on prescription drug use after it is available for use in the community. The cornerstone of pharmacovigilance and pharmacoepidemiological research are postmarketing surveillance data as they demonstrate whether a patient has been exposed to the drug, and adverse health effects that required a health care interaction. These data are generally de-identified which means they contain basic patient information such as date of birth, sex, limited socioeconomic information; and content data for drug databases including drug name, quantity dispensed, and prescribed daily dose (i.e. the amount of the prescribed per day by the clinician). However, content data for each health dataset varies between jurisdictions and health care systems.

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The ability to examine a drug’s safety profile depends on the rate of uptake. If a drug has a slow uptake then it may take years to examine the safety profile and potential adverse events. Alternatively, if there is rapid uptake, and the drug induces an adverse effect, then many people may experience ADEs while the safety of the drug is being investigated. These data may include: prescription data, pharmaceutical claims data, or electronic health records.

Prescription data are generated by general practitioner clinics, where patients present with a symptom/condition and a health care professional prescribes a drug to resolve the issue. However, these data generally overestimate the number of people taking prescription drugs as not all patients prescribed a drug will get the prescription filled at a pharmacy. A patient may decide not to take the drug or symptoms may resolve without taking the drug.

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