You are here
These presentation papers are provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.
The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.
View this presentation for information on:
- what postmarket monitoring is and why it is important
- tools used in postmarket monitoring, including risk management plans
- managing risk and adverse events
- the TGA's early warning system and recall actions.
Slide 1 - Postmarket monitoring
Slide 2 - Overview
- What is postmarket monitoring?
- Why is it important?
- Tools used in postmarket monitoring
- Managing risk
- Adverse events
- Risk management plans
- Recall actions
- Pharmacovigilance Inspection Program
- Other education modules
Slide 3 - 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:
- Changes to product information, safety alerts, recalls
- Enforce compliance
- Assess evidence
Slide 4 - 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- Vioxx was withdrawn from the market worldwide in 2004.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.
Slide 5 - 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
Slide 6 - 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.
Slide 7 - 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.
Slide 8 - 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
Slide 9 - 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.
Slide 10 - 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.
Slide 11 - Who currently reports adverse events?
Medicines pie chart:
- Industry 54%
- State & territory health departments 17%
- Hospitals 11%
- General practitioners 6%
- Consumers 6%
- Community pharmacists 5%
- Others 1%
Medical devices pie chart:
- Sponsors 81%
- Hospital supply and administrators 7%
- Engineers and technicians 1%
- Health professionals 7%
- Consumers 3%
- Others 1%
The TGA is developing strategies to encourage increased reporting by health professionals and consumers
Slide 12 - Why Risk Management Plans? (RMPs)
- Real-world use of a medicine or biological identifies issues that may not have been discovered during a clinical trial
- RMPs are completed by sponsors as part of the registration process for high-risk medicines and biologicals (made from or contains human cells or human tissue)
- They outline the risk management system for a product once it is available for use in Australia
- RMPs are living documents that cover the lifecycle of a product and inform the periodic safety update reports
Slide 13 - Key elements of an RMP
Safety profile of a medicine or biological, including known and potential safety concerns
Plan for how safety concerns will be monitored and how further information will be collected
Risk minimisation activities
Plan for how the risks associated with the use of the product will be minimised
Slide 14 - Safety signals
How we respond
- Signals are information collected from one or more sources that show a potentially causal relationship between a product and an adverse event.
- There are three steps in the signal investigation process
Slide 15 - Step 1 - detecting signals
Involves a review of adverse event reports, international monitoring activities and reports, published literature and post-approval studies to identify harmful effects
Slide 16 - Step 2 - assessing signals
Involves determining the:
- health significance
of potential safety problems and their impact on the overall risk-benefit of the product. This process takes into consideration factors such as whether it is a serious adverse event in a few patients or a moderate adverse event in a large number of patients.
Slide 17 - Step 3 - responding to signals
Regulatory actions taken to mitigate risk include:
- communication of information for consumers, health professionals and industry regarding the problem
- alteration of the product label
- recall of goods from sale or use, or for correction
- changes to the conditions of registration
- suspension or cancellation of the product.
Slide 18 - Case study – one report can make a difference
- Report that an epidural catheter, which is normally clear, was yellow when removed from the packaging for use.
- Upon testing, the yellow catheter was found to be cytotoxic. New, clear catheters (of the same brand) were also found to be cytotoxic.
- Further analysis found a plasticiser used to soften the catheter, n-butyl benzene sulfonamide, is a neurotoxin. The manufacturer had been using it for 30 years with no reports of related adverse events.
- The catheter was reformulated wordwide due to the TGA’s discovery.
Slide 19 - Case study – a handful of reports can uncover previously unknown safety issues
- The TGA received eight reports of serious liver injury associated with the use of lumiracoxib (an anti-inflammatory used to treat osteoarthritis) including two fatalities, two liver transplants, severe jaundice and acute hepatitis without liver failure.
- The TGA investigated the reports and received expert advice that the apparent rate of severe liver injury with lumiracoxib appeared greater than for other similar medicines.
- The TGA immediately cancelled the registration of all forms of lumiracoxib in Australia, on the grounds that failure to do so would create an imminent risk of death, serious illness or serious injury.
Slide 20 - Recall actions
A recall action is taken to resolve a problem with a therapeutic good already supplied in the market. There are three distinct types of recall actions:
Recall: The permanent removal of an affected therapeutic good from supply or use in the market.
Recall for product correction: Repair, modification, adjustment or re-labelling of a therapeutic good.
Hazard alert: Information issued to health professionals about issues or deficiencies relating to an implanted medical device or biological product.
You can search for recall actions via the 'Recalls (SARA)' link under the 'Search databases' section.
Slide 21 - Pharmacovigilance Inspection Program
The TGA's Pharmacovigilance Inspection Program (PVIP) has been introduced to help sponsors meet pharmacovigilance obligations by:
- educating sponsors on their pharmacovigilance requirements
- verifying Australian sponsors' compliance with existing requirements
- working with sponsors to ensure systems are collecting current information on the safety and efficacy of their medicines.
- Safety alerts
- Recall actions
- Medicines Safety Update
- Medical Devices Safety Update
- Introduction to the TGA
- Good manufacturing practice
For more details visit: https://www.tga.gov.au/pharmacovigilance-inspection-program
Slide 22 - Subscribe to the TGA information services to stay up-to-date: www.tga.gov.au
Receive information on:
Slide 23 - Other eductation modules include
*Large file warning: Attempting to open large files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.