Pharma: what are the big serialization opportunities?

As the final preparations for serialization of medicines in the US, Europe and elsewhere get underway and businesses work towards completing their programmes, many are turning their attention to projects that will make more of their serialization investment beyond its regulatory intent. 

FutureLink Munich speaker, Paul Andreianu, the Quality Assurance manager at Leadiant Biosciences and head of the company’s serialization programme, discusses how to use serialization as driver for operational improvement.

Tidying up the house

Serialization offers several opportunities for ‘tidying up the house’ and improving business processes - the biggest being master data.

Years of mergers and acquisitions, divestments and changing contract partners has meant that many pharmaceutical companies are using numerous legacy systems or processes and have spent little time on standardising and finding synergies across the business between them.

Companies must invest time and resources into master data collection and review at the early stages of their serialization programmes. Identifying master data sources and formats is vital but often provokes panic in many businesses due to its complexity.

Having the right master data in place is a determining factor in the success of serialization at the enterprise and network level for businesses. It will also determine the effectiveness of regulations such as the Falsified Medicines Directive. For businesses, it provides an opportunity to make more of their serialization investment by overhauling legacy systems and implementing new processes.

One area that most drug manufacturers would benefit from is removing data artifacts (blocks of information and sources that are obsolete) from their systems. Dealing with complex supply chains in an ever-changing regulatory environment, they will undoubtedly have them and by removing those obsolete blocks of information the companies will generate operational efficiency, improvements in data quality, all easily translated into cost reductions.

Patient engagement and patient-centricity

By investing in patient safety through serialization, pharma companies are taking another important step in building trust among its key beneficiaries of their products. Patient engagement is vital in an industry moving towards the next dimension in its development.

Patient-centricity may have been a futuristic concept a few years ago, today it should be the centre of gravity for any pharmaceutical company.

And one of the enablers of the new patient-centred digital ecosystem is the activated through serialization, adding the option of more granularity when it comes to the pharmaceutical product from batch to unit.

In the long-term, this can support further developments in key pharmacovigilance processes and reduce non-adherence cases by increasing disease awareness.

Delivering the right product…

Making sure the right product is available at the right time is one of the underpinning principles of the FMD. The anti-tampering requirements of the regulation, while being paid less attention than the serialization aspect, are just as important when it comes to delivering drugs to patients safely.

From the patient perspective, anti-tampering evidence is even more important – it is a safety statement that provides assurances that a medicine has been dispensed without any interventions during its transition from the manufacturing site to the dispenser, irrespective of the complexity of the supply chain. There are other potential patient features to be considered like temperature sensitive evidence labels on the pack (e.g. irreversible change of colour in case of exposure to high temperatures for cold chain products, etc.) but the industry should take this one step at a time. This is one area where the sky is no longer the limit.

…at the right time

One of the biggest issues in Europe is drug shortages, which has major implications for patient health. Past and recent drug shortage issues have been caused several factors including:

• A lack of understanding of supply chains and key markets
• A lack of consideration for the lead times in both sourcing APIs and manufacturing products;
• Failures to consider in-depth the complexity of supply chain and their interaction with both EEA and non-EEA “ecosystems”.

In a serialized environment, the additional data being generated by serialization should enable the pharmaceutical companies to develop a better understanding of their supply chain, product use and uptake and use this information to create a more accurate picture of future requirements.

Ultimately, better manufacturing forecasting and understanding of the supply chain reduces the risk of shortages and improves the outcome for patients.

Final thought

Regulatory compliance is simply one of the steps businesses must take on a journey towards realising numerous inherent, short and long-term opportunities, presented by serialization.

Ultimately, the principle of the FMD is to improve patient safety. In the short-term, the law will ensure that patients are receiving the right drug. In the longer-term businesses should be able to use serialization data to ensure that drugs are in the right markets, at the right time, in the right quantities and use packs as a means of opening channels of communication with dispensers and patients. Data will underpin safety for years to come.

Paul Andreianu is a quality manager and business consultant with over 15 years’ experience in pharmaceuticals and healthcare. He has worked as a Qualified Person and as an executive quality professional, and is a member of the EU QP Association, the EU GDP Association and the Pharmaceutical Quality Group. He is currently Quality Assurance manager at Leadiant Biosciences.