In this online exclusive, FutureLink Munich speaker, Dr Andrew Rut, CEO and founder of MyMeds&Me, discusses how serialised medicine will revolutionise patient safety and engagement as well as adverse event reporting in the coming years.
Pills
Much of the discussion around serialisation and the Falsified Medicines Directive (FMD) has been focused on the challenges of implementing a compliant solution, few however are talking about the immense scope of serialised medicine and what it could mean for patients.
The state of play
The way the pharmaceutical industry interacts with patients has undergone wholesale change in recent years. Increased patient engagement fostered by developments in everything from electronic data capture (EDC) systems and patient involvement in healthcare design to new social media strategies and monitoring vital signs using wearable technology, has led to more accurate data being collected faster and in greater quantities.
With the advent of the FMD and the mandate for serialised medicines comes another opportunity to engage with patients and further improve safety.
Patients want to know if their medications are of the veracity, quality and safety that the label claims.Given the growth of generics, where the potential for product quality issues is high, and the emerging biosimilars market, where patients are having increasingly different experiences of drugs, these reassurances are becoming more important. For drug manufacturers, there is a need to know if patients are experiencing adverse effects that might be related to manufacturing quality, supply chain issues or counterfeit products. This is where a disconnect exists that can be eliminated by serialised medicines combined with adverse event reporting at point of use.
Currently, the information about the quality of a batch of product is invariably stored within an enterprise system that may be associated with a local manufacturing site, whereas adverse effects data goes into a central safety database and then on to external agencies. Product quality and pharmacovigilance teams run independent signal detection activities to detect patterns in product complaint data or adverse events associated with a particular medicine. Where the health of a patient has been adversely affected either because of an adverse drug reaction, or lack of efficacy, as much information regarding a clinical incident should be obtained as possible, to allow assessment of the incident. During the manufacture or distribution of a medicine, an error or incident may occur whereby the finished product does not conform to its specification or is for some other reason defective (e.g. presence of a contaminant which may not be detected during routine analysis).
The scope of a serialised pack
The opportunity that comes with serialisation is to simultaneously integrate information on the product and its origins with adverse events. Getting accurate data at source from patients and healthcare providers (HCPs) means that manufacturers can rapidly determine if patient safety issues are likely causally associated with manufacturing quality, supply chain integrity or a falsified medicine. Combining this information also helps to remove the need for reconciliation activities between manufacturing quality and pharmacovigilance teams and organisations. Serialisation has the potential to enable:
- Market Authorisation Holders (MAHs) to have much more granular data on the product, which can help them trend patient safety signals and match them with manufacturing issues and identify potential problems earlier.
- Rapid product/counterfeit identification.
- Immediate linkage of batch/lot with Adverse Event (AE) and Product Quality Complaint (PQC) reports.
- Signal detection/trend analysis can be supplemented by batch sub-groups data.
- Recalls targeted at specific batches.
Pharma companies are looking for ways to increase patient engagement, providing them with both trusted medicines and trusted information.Online communities focused on diseases and the pharma company’s associated medicines provide a portal where patients and HCPs can seek reliable information while simultaneously verifying the product through scanning of serialised packs. This will further increase the value of pharma’s services, removing any uncertainty concerning the identity and origin of the medicine thus driving more meaningful two-way communication and identification of issues early. For patients it means an immediate and trustworthy response to a query or associated AE report or PQC. Clearly the goal is to address issues relating to the quality or authenticity of a product reducing likelihood of harm to patients and ideally assuring them of the quality of the product that they are taking.
Conclusion
Serialisation is expensive and tricky to implement but this is counter-balanced by significant and immediate benefits. Experience in India and elsewhere has shown that simple but powerful interventions with coded products can lead to better adherence, improved clinical outcomes and easier reporting of adverse events.
In a few years, the prescription drug will be a part of a much bigger patient experience, transformed through the mechanics of serialisation, where we’ll see printed DataMatrix codes superseded by Near-Field Communication (NFC) labels. In the future, a code scan of the pack could be part of an adverse event report, if for example, the pack has been diverted from its intended destination without reason.
The industry is already exploring ways to better manage the diversity of data coming through both traditional and non-traditional sources to detect trends that impact patient safety early. Much research is underway using artificial intelligence and machine learning to collect, structure and analyse data.
For drug makers, serialisation is merely the first step of a digitisation journey that will lead to a revolution in the way they engage with patients and ensure their safety.
Dr Andrew Rut will be speaking at FutureLink Munich, which will take place 6–7 June 2018. Designed for both commercial and operational executives from the pharmaceutical and healthcare industries, FutureLink will deliver two separate tracks customised for executives with interests in regulatory compliance or commercial initiatives. For more information and to reserve a seat, please visit FutureLink Munich.