According to the European Medicines Agency (EMA), pharmacovigilance is the process of detecting, assessing, understanding, and preventing adverse events related to licensed medicine use. Medication errors such as misuse, abuse, and overdose may also be studied as part of pharmacovigilance activities.
Pharmacovigilance is particularly crucial for orphan drugs, where clinical trials typically involve smaller sample sizes and shorter study durations. This can lead to potential gaps in the drug’s safety profile, meaning safety issues could arise when the medicine is used in a broader population.
Today, there is more focus than ever on monitoring the safety risks of drugs and deriving warning signs from individual case reports. As per EU regulations, marketing authorisation holders (MAHs) must collect complete adverse event data from physicians, patients, and consumers, combining it with information from other sources such as medical literature and clinical studies. This is then reported to the regulatory authorities for review – a process which must be maintained not just one or two years post-approval but across the entire lifecycle of the medicine. As the data is reviewed, there may be a need to conduct risk minimisation activities such as restrictions, controlled access, safety alerts, or even de-registration in extreme cases.
When a pharmaceutical manufacturer submits an application for marketing authorisation, they must provide a detailed overview of the pharmacovigilance system that will be in place when the product is released to the market. In the EU, they must provide proof that a Qualified Person for Pharmacovigilance is at their disposal. They may also be required to include a risk management plan (RMP) including detailed information on the medicine’s safety profile, how its risks will be prevented, and any plans for further studies to gain additional insights and address gaps in the existing information, such as investigating the product’s safety and efficacy in pediatric/geriatric patient populations or patients often excluded from clinical trials i.e. those with severe renal or hepatic impairment.
As pharmacovigilance systems advance, there is a growing trend towards the use of real-world data derived from electronic health records (EHR), patient registries, and social media. Unlike traditional pharmacovigilance systems which rely on voluntary reporting of adverse events, the use of EHRs may provide more continuous and comprehensive surveillance of a medicine post-approval. It can also facilitate the tracking of medication usage patterns and adherence in real-world settings.
Subcontracting pharmacovigilance activities
Depending on the number of territories a medicine is licensed in, ensuring compliance with local pharmacovigilance regulations can demand significant resources. Due to the expense associated with establishing and maintaining a full department of pharmacovigilance experts, there has been an increasing trend towards outsourcing taking place for many years.
Outsourcing pharmacovigilance brings benefits such as:
- Cost effectiveness: Outsourcing helps pharmaceutical companies save on the fixed employment costs associated with maintaining a full team of in-house pharmacovigilance experts.
- Specialist knowledge: The MAH gains access to highly skilled resources who have experience with a range of product types and risk minimisation measures.
- Flexibility: By working with an external provider, the challenging task of optimising pharmacovigilance resource allocation to the demand of the product is no longer a concern for the MAH.
Nonetheless, while more and more companies are drawn towards these advantages, there is sometimes a concern that the subcontractor will not meet the same standards as the MAH. According to the EMA, while “the MAH may subcontract certain activities of the pharmacovigilance system to third parties”, the MAH “shall nevertheless retain full responsibility for the completeness and accuracy of the pharmacovigilance system master file” – a legally required document which describes the MAH’s pharmacovigilance system.
At Abacus Medicine Pharma Services – an end-to-end commercialisation partner for rare disease products – delivering solutions that meet the stringent requirements of both regulators and MAHs is essential. At the same time, it is vital for us to deliver a customised solution that mirrors our clients’ own processes. This enables a seamless collaboration with consistent results.
“We take steps to understand what our partner’s structures, processes and procedures are and then dovetail with that to ensure that there is continuity and that there aren’t any gaps in the information that we gather,” says Maxine Hamilton, VP Medical & Technical Services.
“Our medical and technical services are all about not prescribing a one-size-fits-all solution or intending to reinvent the wheel. It’s more about understanding the requirements of the client and their product and ensuring regulatory compliance at all times.”
