This morning, whilst grabbing a coffee and scanning through LinkedIn I spotted an advert posted by a former colleague of mine.  The role was to help split the serialisation operations for GSK as the company prepare to “de-merge” their Consumer Health business.

That got me thinking, what are the key bear traps in splitting an organisation’s serialisation operation either due a divestment or in this case a de-merger.  A couple of very specific things jumped to mind . . .

Firstly, the GTIN ownership and management.  The GTIN is broken down into sections as shown in the diagram below.  Part of the number represents the company which this range of GTINs has been allocated to and is between 7 and 10 numbers long.

The most important thing to establish is ‘who will inherit the GS1 company prefix’.  Only one of the organisations can continue to use the company prefix after the divestment or de-merger.  This becomes an issue if the same company prefix has been used on items that will be split between the two organisations.

Diagram of GTIN

This is relatively simple if the organisation only has a single company prefix, however this is often not the case.  In a large multinational there could be dozens of company prefixes all of which need to be identified and analysed.

Simply allocating the company prefix to the organisation which has the most items may not be the most cost effective and easiest to manage.  Although this sounds counterintuitive there are many other factors which need to be considered.  GTINs are increasing being used not just by the supply chain but increasingly for traceability, e-commerce and to access digital content.  The impacts on other stakeholders such as retailers, regulatory authorities and consumers needs to be factored in to understand the best approach.

So, the first issue of GTIN ownership and management has been taken into account, the second important factor is how to maintain serial number uniqueness.

The serial number can be up to 20 digits long and a combination of numbers and letters.  When the serial number is combined with the GTIN is provides a globally unique identifier for the item.

It is good practice not to simply apply serial numbers sequentially, particularly where they are used to help prevent falsification.  Therefore, it is common for IT systems to ‘randomise’ the allocation of serial numbers.  Randomisation is easy to control all the time that the same IT system is allocating the serial numbers, but what happens if the GTINs move to a new organisation which will have a separate instance of the serialisation IT system or perhaps even a new IT system provided by a different IT vendor.

It is important to ensure that the same GTIN & Serial Number combination is never allocated to two different physical packs.  Doing so could have consequences within traceability systems and even lead to real products being identified as fake.

GTIN Diagram

There are several ways to ensure uniqueness is maintained, and the solution will depend on the specific circumstances of the divestment or de-merger.  The simplest is to allocate a new GTIN to the item once transferred to the new organisation, however this is often simply not a workable approach as GTINs are already used extensively outside of the organisation within retail, supply chain, regulatory and traceability systems.

There are then other methods to address the issue of maintaining uniqueness such as the serial number length.  Each method must be considered, and the most appropriate approach selected.

GTIN management and Serial Number Uniqueness are just two of the many factors which need to be addressed during a de-merger or divestment.  Having worked on many such projects, Smarter and Safer Products have built up deep subject matter expertise in planning out the serialisation aspects of mergers and acquisitions.  If you would like help in avoiding the ‘bear traps’ and factoring in key aspects of serialisation transitioning please feel free to reach out.

Written and published by Grant Courtney

 

Devendra Mishra Executive Director of Bio Supply Management Alliance interviews Be4ward Principal Consultant Grant Courtney on the topic of traceability capabilities within the global Covid-19 vaccine supply chains.

Q. How has the lack of visibility/ traceability in the end-to-end COVID-19 vaccine supply chain been of major detriment?  

A. I would suggest that the lack of end-to-end traceability has not been of major detriment to vaccine supply rather that many of the issues being encountered can be attributed to other factors. Very few countries in the world have currently implemented traceability systems across their end-to-end supply chain. Turkey was the first and perhaps the most comprehensive system currently in operation. The system tracks the product from the point of manufacture through to the point of dispense and is used to prevent falsified products, reimbursement fraud, product diversion and promote the safer use of drugs. To achieve this, GS1 Standards have been implemented to allow the identification of items such as a pack, case or pallet and also for locations. Traceability events are then captured as the medicines move through the supply chain. 

Visibility in the Turkish system is achieved through the use of a central traceability system which was financed by the Turkish Medicines and Medical Devices Agency (TİTCK), which is affiliated to the Turkish Ministry of Health. This project took four years to achieve, starting in 2008 and completed in 2012. So clearly the establishment of traceability systems takes many years, relies on the establishment of legislation and requires significant investment and effort across all the stakeholders required to use the system. In Turkey there are over 42,000 stakeholders connected to the system, including 408 manufacturers, 592 wholesalers and over 25,000 pharmacies. 

Another significant example of implementation of serialisation is the European Medicines Verification System (EMVS) which was set up in response to the EU Falsified Medicines Directive.  As the name suggests, this is not a track and trace type system such as the one described in Turkey. The primary purpose of the EMVS is to verify every pack prior to dispense. This system does not provide complete visibility of the supply chain as not all product movements are tracked through the system. The fact that relatively few countries currently operate full track and trace traceability systems, tells us that end-to-end traceability is not a pre-requisite for a well-run and controlled supply chain, although clearly it helps and has additional benefits. 

Many of the challenges for the distribution of a COVID-19 vaccine are going to be the same as any other product, such as the need for common identification of an item, standard barcodes, accurate product master data and supply chain partners who are able to share data and transact through common processes.  It is more likely to be issues in these areas that present challenges to the distribution and management of a COVID-19 vaccinerather than the lack of traceability per se. 

 It could be argued that it is the introduction of common standards, processes and interoperable systems that drives many of the benefits when establishing a traceability system, as these are all needed for traceability to function and are evident in highly efficient supply chains. 

 Utilising common barcodes at all levels of the packaging from the vial up to the pallet would allow items to be scanned and the data captured for Logistic and Clinical purposes. Product Master is made available to all stakeholders so that systems can be populated. Transitions based on global protocols and standards ensures there is more interoperability of processes and systems. These are all factors that enable any supply chain to operate with Global Standards very much the DNA of any highly efficient and effective supply chain.  

 

Q. How can serialisation of drugs and vaccines enable the required integrity in the manufacture and distribution of drugs? 

A. Although serialisation and traceability are not the primary factors in operating efficient supply chains, there are benefits which come with their implementation. Traceability through the vaccine supply chain using track and trace offers benefits by providing full product visibility from manufacture to patient’s arm. Knowing where inventory is at each stage of the supply chain makes for a safe and efficient supply chain. The benefits go further than just manufacture and distribution, all the way to administration of the drug and pharmacovigilance.  

By giving each product a unique identifier, we know it is a legitimate vaccine, we know the vaccine type and how many doses are contained in a vial. We also know the location of each vial at all times. This full visibility aids redistribution, recall and the integrity of supply chain before we even consider the big benefits of preventing product falsification and diversion. 

As we collect more data on these vaccinesit could be that we are able to extend shelf life. Traceability and digital data store to vial level allows us to update information held without having to recall or waste product. Similarly, there are benefits relating to electronic patient information. Much of this product is going out in common packaging across all countries, in a single language on the packaging. Barcodes can be used to scan and access leaflets in different languages.  

Due to the acceleration of manufacture with these vaccines, extra vigilance is required relating to, for example, side effects. Robust, reliable product data is essential here with product code and batch code linked to patient records for pharmacovigilance purposes.  

 

Q. In the emerging global situation of the disparity between demand and supply of COVID-19 vaccines, falsified products may appear in the marketplace. What is the solution? 

A. Unfortunately, we have already seen criminals profiting from the pandemic. Initially this was PPE items and some therapeutics, but there are now reports of criminal gangs gearing up to supply fake vaccines. In February 2021 authorities in China arrested over 80 people and 3,000 doses of fake COVID-19 vaccines were confiscated. It is understood that the group had been profiting from making and supplying the fake vaccines since September 2020 and that it is likely these were destined for export to countries in Africa. We have the conditions for the perfect storm, high value vaccines with high demand and low supply. This is a recipe for falsified products which will be distributed through both physical and online channels.  

 There is no single solution to solving falsified crime. If there were, we wouldn’t be facing the issue. What’s needed is a suite of capabilities and solutions in place to minimise the risk and take into account the national environment and needsPatients want this vaccine in their arm. It’s the key to reopening lives and economies. It will afford the vaccinated greater freedoms, and therefore strong demand existsConsequently, some patients will buy it illegitimately, whether just queue jumping or due to concerns over a lack of supply.  

One route for falsified product to enter the marketplace is via the internetI’ve written an article relating specifically to cybercriminal activity around these vaccines, whereby efforts to fight this crime are being made by organisations such as EAASM and ASOP, to raise awareness with consumers. This is where the high media profile of these vaccines is of benefit. It’s highly publicised that there is no extra out there, so unless your vaccine is secured via legitimate channels, it’s fake. Also, policing the sellers and monitoring cross border movements helps the effort

As well as tackling the illegitimate supply chain, we must also secure our legitimate supply chain. This highly valuable product is hugely vulnerable to theft and hijackingleading to the dangerous situation of spoiled batches in circulationThis is a particular issue in low-middle income countries. We need to put systems in place with monitoring efforts on the legitimate supply chain to ensure its security 

 

Q. With the desire to foster international travel, what is a Healthcare Passport for travellers? 

A.  A Healthcare Passport for the vaccinated would extend beyond just travel, it could mean individuals being able to work, attend a conference, or visit a care home. If we are granted more freedom or have more opportunities offered to us by being vaccinatedthen the evidence we carry becomes very valuable and therefore a target for forgeryMethods of proving vaccination in a failsafe way is a huge challenge.  For example, who confirms you’ve been vaccinated?  Staff at the centres are busy vaccinating and caring, so who keeps the recordsWe will need to create a link to the record of administration and who the patient is, relying on robust identification at the point of vaccination. All this requires further levels of administration and staffing.  

These passports are going to be really important if we’re going to get some industries safely back up and running, such as travel, leisure and entertainment industries. But how will we make them as secure as current travel passports or online banking for instance?  

 

Q. How can IoT enhance the potential business value of serialisation? 

A. Web enabling packs, where every pack can be treated as a unique thing with a unique identifier brings about huge benefits. This means you can leverage track and trace, but also can provide additional information about each specific thing by scanning to get to additional pack contentThis could be for example a leaflet in a different language, or the new expiry date. You can create use cases such as product verification to link to patient records.  

 

Q. How would you quantify the economic value of an investment in serialisation?  

A. The two main benefits of patient safety and supply chain efficiencies are hard to put an economic value on. Patient safety, the safe product correctly administered, means less stress on the healthcare systems. Unsafe product could result in legal action, people being removed from the workplace, damaged healthcare systems, reduced staffing and additional treatments, all at huge cost to society. Improving the efficiencies of your supply chain presents great economic value too. With COVID-19, the global economic cost has been extreme. A stronger, more visible supply chain for the vaccines will help us reopen societies and begin our recovery.  

 

Understand the full impact of these multiple pieces of legislation on the company and product supply chain

Serialisation presents a potentially broad impact on a typical organisation. It is important to engage all of the potentially impacted parties early in the impact assessment phase to ensure that comprehensive solutions can be defined.

A further challenge is that multiple pieces of evolving legislation will often impact many of the same capabilities. Understanding these potential impacts and their likely evolution over time is key to ensuring effective solutions are defined and implemented in a timely manner.

I’m looking forward to attending and leading a workshop session at the Pharmaceutical Traceability Forum next month, November 16-18 at the Boston Park Plaza. My workshop, “Global Serialization Legislation Update and Management” will be held on Monday, November 16.

I’ll be joined with industry experts from organizations including Abbott, McKesson, Bristol-Myers Squibb and others who will be leading the knowledge-sharing sessions, in-depth discussions, pre-conference workshops and much more.

The Forum is designed to provide key strategies, solutions and techniques throughout the three-day program. Topics include:

Download the event agenda here.

Use Be4ward’s own promo code when you register to take 20% off registration. Just provide “2PTF_BE4WARD” when you register online at www.pharmaceuticaltraceabilityforum.com, email [email protected] or
call 1-800-882-8684.

 

As I discussed in my last blog on the topic, the Ministry of Health in Russia has published a  draft federal drug traceability law.

As you would hope, the likes of the Association of International Pharmaceutical Manufacturers (AIPM) have responded to the Russian Ministry of Health (MoH) with the following points, which seem to cover most of the key concerns that manufacturers have.

The AIPM have issued a questionnaire, urging companies to let them know their timeline to readiness and the significant investment that will be required. They intend to use this to further influence the MoH.

Do you think the AIPM missed any key points?

Should you have any questions about this or any other of my blogs, or would simply like to request a copy of my booklets, please don’t hesitate to contact me at [email protected].

Available for request:

Serialisation Lessons Cover     Serialisation Legislation Cover     Booklet image (2)

 

The Ministry of Health in Russia has published a  draft federal drug traceability law, a Russian version of which is on the official website www.regulation.gov.ru.

The draft law proposes to introduce a national electronic system to track product from manufacturer to end user, identifying product down to the primary pack level with machine readable coding. Unfortunately, as usual, the types of details that allow companies to implement solutions are absent from the law and will follow in an implementation document. So the full complexity of what is being proposed is uncertain at the point.

I also understand that this system may be used to manage drug pricing across Russia.

If the likes of primary coding requirements are not enough cause for concern, the proposed timelines are enough to send serialization program owners straight to the whisky cabinet:

The Association of International Pharmaceutical Manufacturers have sent a letter to the Russian Ministry of Health pointing out a number of significant concerns with the draft legislation and it’s timing. They also urge individual companies to complete a questionnaire explaining their timeline to readiness and the significant investment that will be required. But more on that next week.

Any thoughts on how you think this will pan out?

Should you have any questions about this or any other of my blogs, or would simply like to request a copy of my booklets, please don’t hesitate to contact me at [email protected].

Available for request:

Serialisation Lessons Cover     Serialisation Legislation Cover     Booklet image (2)

Pharmaceutical product serialisation legislation is being developed and approved across the World to ensure patient safety and prevent fraud. Achieving this across the supply chain is a major and very costly undertaking. Failure to comply with these legislative requirements will mean that pharmaceutical companies will not be able to sell products in the affected markets.

Serialisation legislation requires that every product pack is uniquely identified and registered in an external agency database, together with information about the product contained in the pack. Depending on the particular legislation, it may also be necessary to update the external agency database with product movement and change of ownership information, a significantly more complex requirement.

Whilst some pharmaceutical companies understand this legislation and have a clear strategy and program of capability implementation under way, others do not.

This series of articles outlines the requirements of serialisation and related product coding legislation, discusses what needs to be done to address it and identifies some next steps to effectively manage the risk.


This is one in a series of articles outlining the requirements of serialisation and related product coding legislation, discussing what needs to be done to address it and identifing some next steps to effectively manage the risk. Please help me improve the thinking by adding your comments and share this with others who may have a view.

To obtain an e-copy of our paper on the topic, go to www.be4ward.com or contact me directly at [email protected].

Many thanks to Alan Reynolds and the team at CAPDM for inviting me to speak to them about global trends in product coding and serialization.

I had the pleasure of presenting to about seventy of the CAPDM members a couple of weeks ago in Toronto. We discussed a simple model to help understand the requirements of the various pieces of legislation around the world and the impacts that this has on the supply chain.

The Canadian supply chain is faces imminent legislation to manage product coding at the item level in the vaccines supply chain, and guidelines to extend this to all Pharma products in the next few years. Whilst serialization is not likely for a number of years, I understand that Health Canada are closely monitoring the US epedigree and Global situation, with the intention of considering legislation in the next couple of years.

Many thanks to Anna Fraenkel and the team at IQPC for organising this year’s Packaging and Labelling Summit in Basel, it was a great event that was well attended.

I have pulled out a few my highlights of the event below.

Book launch and chairing the event

My colleague and co-author Andrew Love chaired the first day of the event and we took the opportunity to officially launch our new book, Developing and Sustaining Excellent Packaging Labelling and Artwork Capabilities, which is now available on Amazon.

Many thanks to those people who took the time to flick through the book during the event and give us some great immediate feedback.

Falsified medicines directive and serialisation

Clearly, given the recently published Falsified Medicines Directive in Europe, a focus of attention at the Summit was on serialisation. It took me back to my time managing serialisation at GSK to listen to the speakers from a number of Pharma companies and suppliers share their experience of implementing serialisation pilots and the first live implementations.

Of the many messages, a few came through from all the speakers:

When asked about the likely timing of the publishing of the detail requirements for the legislation, which then drives the implementation timing three years later, the panel discussing the topic were unanimous in believing that these requirements would be published in late 2013 or early 2014. This would set a likely implementation date in most European countries of 2017.

Single dose pack marking

Dr Roberto Frontini, from the European Association of Hospital Pharmacists, gave a very interesting talk on research that demonstrates that individual dose, machine readable pack marking significantly increases patient safety.

I would emphasise that this has nothing to do with serialisation, as the requirement here is to mark the individual dose (e.g. a blister pocket or vial) with a machine readable code (e.g. 2D datamatrix) containing the product code (e.g. Global Trade Identification Number). With this, scanners and computer systems can be used in the process of dispensing and administering drugs to patients to ensure that they are receiving the right medicine.

If the information in this dose marking is limited to product codes, then the coding can be built into static packaging labelling and artwork, significantly simplifying it’s adoption by manufacturers.

Packaging’s role in patient compliance

Tassilo Korab from the European Healthcare Compliance and Packaging Council (EHCPC) gave a talk and hosted a round table discussion on the topic of packaging’s role in ensuring patient compliance. In the context of the discussion, compliance was taken to mean: right medicine; right dose; right application; right time and for the duration of the prescription. Soren Skovlund, form Novo Nordisk, also spoke on the topic.

Whilst research shows that the reasons poor compliance are many and complex, packaging and the information provided on it, and linked to it electronically, are clearly key elements to improving compliance. One of the key thrusts of the EHCPC’s argument, is that we need a better balance between the often opposing requirements of [providing information and motivation to patients to improve compliance] and the need to avoid [Pharma companies advertising too and unduly influencing drug choices.]

The EHCPC and it’s members believe that there will need to be a readjustment of the current regulatory focus in many countries on using packaging to ensure all the risks of a medicines are spelt out to patients, as this is not a very encouraging message where compliance is concerned.

 

It is highly likely that one or more parts of your organisation are already working on this issue, perhaps in a coordinated way, perhaps not. Initially, we would recommend continuing this work until the appropriate course of action has been decided.

We would recommend a small and focussed piece of work which has the following objectives:

From here, a programme of activity can be managed by the governance team to effectively manage the legislative risk.

How we can help

Our Be4ward team has many years of experience in managing and implementing solutions for serialisation for some of the world’s largest and smallest pharmaceutical companies.

We offer a range of services to assist our clients in the following areas:

As a first step, we would welcome the opportunity to discuss your situation and identify any immediate areas in which we might be of assistance.


This is one in a series of articles outlining the requirements of serialisation and related product coding legislation, discussing what needs to be done to address it and identifing some next steps to effectively manage the risk. Please help me improve the thinking by adding your comments and share this with others who may have a view.

To obtain an e-copy of our paper on the topic, go to www.be4ward.com or contact me directly at [email protected].

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