Trends Affecting Pharmacovigilance 21 Nov 2022
Pharmacovigilance (PV) – the proactive maintenance of drug safety through collection, detection, assessment, monitoring and prevention of adverse effects – has been evolving since the first concerns were raised over the negative effects of chloroform anaesthetic in the 1800s.
Since that time, the safety of medicines has been taken more seriously as new therapies have come onto the market. However, it was only in the 1960s that various PV approaches were formalised in the US and Europe, following the discovery of links between Thalidomide and birth defects.
Methods for maintaining medicines’ safety regulation and monitoring have been accelerating ever since, especially in recent decades, to keep pace with the explosion in new therapies and medical technologies.
It is vital that PV keeps pace with the latest advances, so what are the trends to look out for today?
Data Mining and Assessment
While safety is reviewed throughout all phases of the drug life cycle, post-marketing assessment remains important to assess therapies over a longer period in a real-world setting. Today, large quantities of health data – both from distributed databases and generated by digital tools – provide new and increasing opportunities to investigate and use them in health surveillance.
Alongside this proliferation of data, the means are now available to mine it. Artificial intelligence (AI) can use natural language processing (NLP) to sift information and uncover details about adverse drug reactions (ADRs), as well as drug-to-drug interactions.
Both public and private organisations are developing AI solutions to process ADRs automatically.
Applications for AI and machine learning in PV include the automation of case report entry, the discovery of patterns of adverse events (AEs), and modelling based on real-world evidence to predict and prevent AEs.
Safety of Digital Therapies
The rising number of digital therapeutics (DTx) approved and under review requires corresponding scrutiny to assess their effectiveness and safety in real-world use. While these are clinically evaluated before launch and side effects may be milder and easier to manage that those of drugs, there is still a need for ongoing monitoring post marketing.
In addition, DTx provide vast amounts of data that can be examined to inform safety and effectiveness in the real-world environment. Possible drawbacks here include the need to maintain patient data privacy and ensure the quality of the data being mined. Any government frameworks put in place must support these requirements.
The UK wants to position itself as a leader in technology innovation for health, with the government’s MedTech strategy expected soon. As part of this, the Medicines and Healthcare products Regulatory Agency (MHRA) launched a roadmap on 17 October 2022 to explain how its Software and AI as a Medical Device Change Programme will be actioned. Its approach is to issue guidance initially, with secondary legislation introduced as needed, following consultations with stakeholders. This programme is part of the wider proposed reforms to the Medical Devices Regulations 2002, feedback on which was outlined by the government in June 2022.
The complexities of the issues here cannot be underestimated, but providing guidance, rather than legislation, should speed delivery to industry and allow the MHRA to respond quickly to changes in this fast-moving sector.
Advanced Therapy Medicinal Products
Advanced therapy medicinal products (ATMPs) represent another growing area of focus for PV. Often ATMPs are given accelerated assessment and approval, which places greater emphasis on post-marketing data to understand their benefits and risks. Also, many ATMPs serve rare disease populations, which, by definition, have low patient numbers for trials and poorer pre-marketing data as a result. PV has a part to play in filling gaps in knowledge across the drug development process and ensuring safety in the longer term. Furthermore, some ATMPs are one-off treatments, meaning that PV has an ongoing role over a patient’s lifetime.
It is important to keep up to date with the latest pharmaceutical and health trends that are impacting the operation and evolution of PV, to ensure drugs, devices and, increasingly, medical technologies, are safe at all phases of development, as well as during and after use in the real world.
Help is at Hand
If you are working on a new drug or device and are not sure what the requirements are regarding safety and regulation, in the UK and farther afield, PharmaMedic Consultancy’s team of experts is ready to assist you through the process. Please contact us to find out how we can help you get your product to market and beyond.