Postmarket monitoring

Postmarket monitoring

Overview

• What is postmarket monitoring?
• Why is it important?
• Tools used in postmarket monitoring
• Managing risk
• Adverse events
• Risk management plans
• Signals
• Recall actions
• Pharmacovigilance Inspection Program
• Other education modules

What is postmarket monitoring?

The aim is to continually monitor and evaluate the safety and, in some cases, the efficacy or performance of therapeutic goods that are available on the market and to manage any risks associated with individual products.

We regulate therapeutic goods throughout their lifecycle in a number of ways:

• Register
• Monitor
• Changes to product information, safety alerts, recalls
• Enforce compliance
• Assess evidence

Why is this important?

Not all risks can be identified before registration

• Vioxx was first approved in Australia in 1999 for symptomatic treatment of osteoarthritis and rheumatoid arthritis.
• Postmarket study showed an increased risk of cardiovascular events beginning after 18 months of treatment in patients taking the recommended daily dose.
• Compared with placebo, this equated to one extra cardiovascular event for each 65 patients who took Vioxx for at least 18 months.
• Vioxx was withdrawn from the market worldwide in 2004.
• This was one catalyst for more vigorous postmarket monitoring for regulators around the world.

Tools used in postmarket monitoring

• Risk management  plans (RMPs)
• Adverse event reporting and Pharmacovigilance Inspection Program (PVIP)
• Environmental scanning (seeking confidential advice from other regulators and review of medical literature, regulatory news, media and other sources)

As a future health professional, you can help by learning how to report adverse events

Managing risk

• The TGA works on a risk-benefit assessment of products at a population level. The benefit of taking the medicine or using the device should be greater than the possible adverse events.
• Higher levels of risk may be acceptable for a product used to treat a terminal illness, but not for a common or minor complaint.

Definition of an adverse event

• For both medicines and medical devices: an event that resulted in, or could have resulted in, serious injury, illness or death.
• A medical device adverse event can also be associated with the use (or misuse) of a medical device. This may include difficulties or malfunctions, such as problems with getting the device to operate, the need for repeated repairs, difficulty of use or difficulty with cleaning after use.

Your role as a health professional

• You play an important role in monitoring the safety of therapeutic goods by reporting any suspected adverse events to the TGA.
• Reports can be made online, or by phone, fax or email.
• Visit the TGA website for more information about reporting.

Search the databases of adverse event notifications to see what has been reported to the TGA

What should you report?

The TGA is particularly interested in:

• serious or unexpected reactions to medicines (this is explained further on the next slide)
• serious medicine interactions
• faults or problems with medical devices that have resulted, or could have resulted, in adverse events.

Reporting serious and unexpected reactions to medicines

It is most important to report serious and unexpected reactions to medicines. These are distinct from well known side effects. For example, we would not expect reports of:

• tiredness after taking an opiate based painkiller
• nausea or diarrhoea after taking certain antibiotics.

Who currently reports adverse events?

2016 data

Medicines pie chart:

• Industry 54%
• State & territory health departments 17%
• Hospitals 11%
• General practitioners 6%
• Consumers 6%
• Community pharmacists 5%
• Others 1%