Post-marketing Surveillance & Pharmacovigilance

915- 9/23/26

define post marketing surveillance?

the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market

define pharmacovigilance?

the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

What does post-approval monitoring evaluate?

Long-term safety and effectiveness in real-world use.

What happens to drugs before FDA approval?

Discovery → preclinical testing → Phase I–III clinical trials.

How was widespread thalidomide use largely prevented in the U.S.?

FDA reviewer Dr. Frances Kelsey refused to approve the drug

What does the thalidomide case demonstrate?

The importance of rigorous drug safety oversight.

When does drug safety monitoring end?

It does not end at approval; safety must be monitored continuously.

Why must drugs be monitored throughout their lifecycle?

To ensure ongoing safety after approval in real-world use.

what is the purpose of post marketing surveillance?

to identify unwanted and negative consequences associated with the use of a given medication (as opposed to side effects)

what are two examples of consequences with the use of a given medication?

1.Adverse events (AE):

2.Adverse drug reactions (ADR)

define adverse events (AE)

any untoward medical occurrence in a patient

administered a medicinal product and which does not necessarily have to

have a causal relationship with this treatment

define adverse drug reactions (ADR)

noxious and unintended responses to a medicinal product; a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility

define safety signal

Information from ≥1 sources suggesting a possible drug-event association.

Safety signal: Information that suggests a possible new drug safety problem that may need regulatory action.

What can a safety signal suggest?

A new, potentially causal association between a drug and an event.

what is a second thing a safety signal can suggest?

A new aspect of a known association between a drug

and an event that is of sufficient likelihood to justify

regulatory action

What does the FDA evaluate when reviewing a medicine?

Its efficacy and safety.

What must be true about a medicine’s potential risks?

A medicine must demonstrate meaningful

clinical benefit, while its potential risks must

be acceptable and manageable

When does the FDA evaluate a medicine’s benefit-risk balance?

Continuously throughout the drug’s lifecycle.

What is the FDA balancing when evaluating a medicine?

Its clinical benefits against its potential risks.

What should pharmacists do when they suspect an adverse drug event?

Recognize and document suspected adverse

drug events

Where should pharmacists report serious or unexpected adverse events?

Report serious or unexpected events to FDA

reporting systems, such as FAERS/MedWatch.

What should pharmacists encourage patients to do?

Encourage patients to report adverse events

and provide relevant safety information.

what do surveillance systems do

monitor prescription drug

safety, illicit drug markets, and substance-related

morbidity and mortality

What are examples of passive adverse event reporting systems?

• MedWatch → FDA Adverse Event Reporting System (FAERS)

• Vaccine Adverse Event Reporting System (VAERS)

What is FAERS?

FAERS is a post-marketing pharmacovigilance database that collects reports of suspected adverse events after drugs enter the market.

Who can voluntarily report adverse events through MedWatch?

Healthcare professionals and patients.

What reporting responsibility do drug manufacturers have?

They have regulatory reporting obligations to the FDA.

What type of surveillance is FAERS used for?

Post-marketing pharmacovigilance (drug safety surveillance).

What is the VAERS reporting form?

A form that can be submitted online, by fax, or by mail.

What information does the VAERS form collect about the person submitting it?

It identifies the reporter, such as a parent, healthcare provider, or vaccine distributor.

Is reporting through VAERS always voluntary for healthcare providers?

No. Some adverse events require mandatory reporting by healthcare providers.

What does the FDA do after a drug is approved?

The FDA continues to monitor the drug’s safety.

What can happen when new safety risks are identified?

The FDA can take different actions to protect patients.

What determines the FDA’s response to a new safety risk?

The seriousness of the safety concern and the actions needed to protect patients.

What is a Black Box Warning?

An FDA-required warning highlighting serious or potentially life-threatening risks in a drug’s prescribing information.

What is the purpose of a Black Box Warning?

Alerts healthcare

professionals and patients to serious

risks that require careful consideration

when prescribing or using the

medication.

What is a (REMS)Risk Evaluation and Mitigation Strategy?

An FDA-required program for certain medications with serious safety risks.

What is the goal of REMS?

To prevent, monitor, or manage a particular safety risk.

What may REMS require to ensure safe medication use?

Specific actions by prescribers, pharmacists, or patients.