What is Pharmacovigilance?
The definition of Pharmacovigilance is the science and activities related to detecting, assessing, understanding and preventing the adverse effects and other medicinal products related problems.
Essentially, once products are released to market, manufacturers are legally obligated to conduct monitoring activities to detect any warning signs that their products could negatively impact a patient’s wellbeing.
The level of monitoring is commensurate with the level of risk posed to the patient. New medicines that have very little data to support their safety will require stricter and more frequent monitoring activities whereas low risk products like complementary medicines could get away with less frequent checks.
Pharmacovigilance can get complicated, and I strongly recommend reviewing the regulations carefully, in this blog I have provided a high-level summary of some of the core key topics.
Why is good pharmacovigilance practice needed?
So, imagine you’re the owner of a pharmaceutical company, it could be API manufacture, complementary medicines, or even medicinal cannabis. You’ve just released a product to the market and it’s selling well.
Job done, you can now focus on the next product, right?
When a batch of medicine is released to the market it activates a monitoring system known as Pharmacovigilance, or Good Pharmacovigilance Practice.
Who does Pharmacovigilance apply to?
It is important to clarify that pharmacovigilance only applies to manufacturers or sponsors who have medicines registered or listed on the Australian Register of Therapeutic Goods (ARTG).
Unapproved medicines used in Clinical trials or supplied under the Special Access Scheme (SAS), or Authorised Prescribers (AP) Scheme are subject to similar but separate reporting requirements that are managed under different guidelines. Scroll to the last section of this blog for more details.
What are my Pharmacovigilance responsibilities?
Sponsors of medicines that approved for supply in Australia have the following responsibilities:
- Nominate an Australian Pharmacovigilance contact person to the TGA.
- Monitor products for adverse events and significant safety issues.
- Submit any serious adverse reaction reports to the TGA.
- Notify the TGA of any significant safety issues.
- Maintain up to date and accurate records of adverse events and provide information to the TGA when requested.
The list is deceptively short; each of these items have different methods of reporting as well as different reporting timeframes. Refer to Your regulatory reporting requirements at the TGA website for more details.
What are Adverse Events?
The most common way to detect if there is something amiss will be through consumers or medical practitioners reporting that there has been an Adverse Event. Adverse Events (a.k.a. side effects) come in a range of categories relating to whether the effects are:
- actual vs suspected (“suspected” events are still treated like “actual” events)
- expected vs unexpected
- serious vs non-serious
- valid vs non valid.
I recommend looking at the full definitions on the TGA website.
A simplified rule of thumb on how to process your adverse events is provided in the image below. Where your adverse event falls on the chart will influence whether you can just record the data in-house, or if it will require escalation to the regulator.
However, if you find that an adverse event needs to be reported to the TGA you must first check its validity and ensure the minimum required details have been captured, including:
- contact details for the reporter (name, address, phone number)
- patient identifier (such as initials, date of birth or age, but not their full name)
- details of the product involved
- details of the suspected adverse event.
If you haven’t captured these details, you cannot report the adverse event to the TGA, but you must keep in-house records.
NOTE: While you don’t need to report non-serious adverse events (including overseas reports) you may be requested by the TGA to provide a Periodic Safety Update Report (PSUR) so you should always have data readily on hand. If you have overseas customers, ensure that you have covered this reporting requirement in your commercial agreements!
How else can I detect potential safety issues?
Pharmacovigilance is not just about detecting when things go wrong via adverse events, but also picking up signs that things could go wrong. Thus, companies are also expected to monitor for “significant safety issues.”
Significant safety issues are essentially any signal detected during monitoring that raises concern or suspicions as to the ongoing safety and suitability of a product. As a part of their Pharmacovigilance strategy, sponsors should identify main keywords such as the drug name, active ingredients, materials, etc. and use these to screen external sources of information.
However, signals are not limited to external cues, and may also be detected in-house through the Quality system audits, or even reported by employees themselves. A few examples of areas to where safety signals may be detected are provided in the table below:
The TGA expects sponsors to use professional judgement and proceed according to risk when determining whether a safety signal is significant enough to report to the regulator.
When reporting you should include:
- A description of the safety issue
- Source(s) of information
- Your assessment of the risk and potential impact of the issue
- Any actions you propose to take, or justification for no further action
- Any relevant documentation.
More information can be found on the TGA page for sponsor reporting requirements.
What other safety signals do I need to be mindful of?
This is where Pharmacovigilance can get complicated. It is one thing to watch out for incidents and factors that could cause your product to trigger an adverse event, but the following also requires some consideration:
- Adverse exposure to your product during pregnancy and breastfeeding. Separate reports must be raised for the baby and the mother, and the baby followed up post-birth to ensure there has not been any serious long-term harm or congenital defects.
- Lack of efficacy of the product.
- Reports of transmission of an infectious agent in a batch.
- Reports of overdose, abuse, off-label use, misuse, medication error or occupational exposure.
Refer to Monitoring and collecting information for more information.
How I do to report adverse events for unapproved medicines?
Prescribing health practitioners are primarily responsible for reporting adverse events or defects arising from the use of unregistered or unlisted medicines under the clinical trial, SAS, or AP schemes.
However, Sponsors also hold responsibility for:
- monitoring the use of their medicines under those schemes
- reporting any unexpected serious adverse reactions, effects, and defects to the TGA
- continually assessing the risk-benefit of the product’s use.
It is also recommended for sponsors to request adverse event reporting from their prescribing health practitioners to ensure the business stays on top of the latest data. The TGA must be advised of any information that impacts the benefit-risk assessment of the product—particularly any information that could change how the product is used under the SAS.
If you found this content useful, and would like to develop your systems further, PharmOut sells a Pharmacovigilance template pack to help you get started on your monitoring journey. You can also get in contact to schedule a chat with one of our experienced consultants.
If you found this blog useful, you may also be interested in the ones below:
- PIC/S GMPs vs WHO GMPs – what’s the difference?
- Impact of COVID-19 on Pharmaceutical Manufacturing
- Pharmaceutical Quality Systems (PQS) 101
Or attend one of our online training courses on pharmacovigilance