After nearly 10 years since the Drug Supply Chain Security Act (DSCSA) was signed into law, the deadline for tracking and tracing serialized pharmaceutical products across the US supply chain will come into force in November this year.

Most manufacturers have plans and ongoing activity in place to meet this deadline. However, some, often for very good reason, do not. If you fall into this latter category, read on. If you do have plans and activities in place, then chances are that you have worked with one of the Be4ward team at some point over the last 15 years in developing them.

DSCSA requires manufacturers to put in place several significant elements to help secure the US pharmaceutical drug supply chain:

There are many ways to achieve the above, depending on the nature of your supply chain and the scale of your operations. For smaller manufacturers, this will often involve working closely with and coordinating activity across several internal functions, Contract Manufacturing/Packaging Organizations (CMO / CPO), 3rd Party Logistics organizations (3PL), Wholesalers or Specialty Pharmacies and product traceability system vendors.

If you are unsure that your company understands these requirements fully, or that your plans will get you to compliance on time, we are here to help.

Be4ward is one of the longest standing serialization and traceability consultancies, with a team of senior specialists that have worked with many manufacturers, industry groups and standards organizations over the last 15 years, delivering successful serialization solutions.

After nearly 10 years since the Drug Supply Chain Security Act (DSCSA) was signed into law, the deadline for tracking and tracing serialized pharmaceutical products across the US supply chain will come into force in November this year.

Most manufacturers have plans and ongoing activity in place to meet this deadline. However, some, often for very good reason, do not. If you fall into this latter category, read on. If you do have plans and activities in place, then chances are that you have worked with one of the Be4ward team at some point over the last 15 years in developing them.

DSCSA requires manufacturers to put in place several significant elements to help secure the US pharmaceutical drug supply chain:

There are many ways to achieve the above, depending on the nature of your supply chain and the scale of your operations. For smaller manufacturers, this will often involve working closely with and coordinating activity across several internal functions, Contract Manufacturing/Packaging Organizations (CMO / CPO), 3rd Party Logistics organizations (3PL), Wholesalers or Specialty Pharmacies and product traceability system vendors.

If you are unsure that your company understands these requirements fully, or whether your plans will get you to compliance on time, we are here to help.

Be4ward is one of the longest standing serialization and traceability consultancies, with a team of senior specialists that have worked with many manufacturers, industry groups and standards organizations over the last 15 years, delivering successful serialization solutions.

Principal Consultant Grant Courtney provides an overview of the findings of the recent Operation Pangea, looking at what the rise in the fake medicines and the consequences of Brexit means for the UK and what action needs to be taken to protect our supply chains. 

Operation Pangea is an international effort coordinated by INTERPOL, across 92 countries, which aims to disrupt the online sale of fake and illicit health products.

Through the combined work of regulatory bodies, healthcare companies, customs and the police, millions of potentially dangerous medicines are prevented from reaching patients each year.

In addition to seizing falsified product the operation also successfully brings down websites and online marketplaces operated by criminals, dismantles criminal gangs and raises awareness of the risks to the public.

Operation Pangea XIV (2021) ran from May 18 – 25th and it comes as no surprise that products related to the COVID-19 pandemic featured heavily, with testing kits accounting for more than half of all medical devices seized.

The numbers speak for themselves:

• 277 arrests. • 113,020 web-links taken down. • $23m worth or illicit products seized.

What is really telling is the dramatic increase in the value of seized products, up 164% over 2020 numbers.  The UK was a focal point of this year’s operation with over 3 million medicines and medical devices seized with a value of almost $13 million.

Whilst Pangea focuses on the illegal on-line sale of medicines, we must not forget that falsified drugs also enter the legitimate supply chain.  Between 2011 and 2014 thousands of stolen medicines from Italian hospitals were taken out of the controlled supply chain and ended up in pharmacies across the UK, this included Lyrica, the epilepsy drug, but also medicines for prostate cancer and schizophrenia.

Legislation such as the EU Falsified Medicines Directive (EU FMD) has been enacted with the specific objective of providing  protection to patients from Falsified Medicines entering the legitimate supply chain, however since Brexit the EU FMD no longer applies to Great Britain.

In October 2020 the Royal Pharmaceutical Society (RPS) wrote to the health secretary, Matt Hancock and asked for plans to be established to help authenticate medicines that move between the EU and UK.  The RPS were concerned that the removal of safeguards provided by the EU FMD could lead to an influx of falsified medicines.

Clearly Pangea XIV and historical cases show that the UK is a target of an increasing level of criminal activity and the implications of the Pandemic and Brexit leave patients more exposed than before.

Our attention must therefore focus on two important legislative areas, the first is the Digital Services Act (DSA), as this represents an opportunity to help prevent criminals anonymously operating on-line websites and selling to the public.  The second will be the UK legislation which replaces the EU FMD.  Both of these will be critical to the continued fight against fake medicines.

 

Image: Fake medicines seized during Operation Pangea XIV (2021) - Photo source INTERPOL

Electronic Product Code Information Services (EPCIS) is a global GS1 Standard for creating and sharing supply chain information, both within and across enterprises, which enables companies to gain shared, often real time visibility of their end-to-end supply chains. Anyone who has been involved with trying to make business processes and information flow across multiple organisations and IT systems will understand the value of such standards to govern data format and transfer methods. This is the reason for the existence of organisations like GS1 and why it’s member organisations pay it’s fees, and often contribute significant employee time to helping develop these standards. This is also why those same member organisations implore regulators to adopt and mandate those standards in their legislation.

 

Today, compliance to these standards brings benefits such as a reduction in the cost of maintenance or upgrade of interconnected system and increased agility to change supply chains. In future, adherence to these standards will be the key enabler that allows companies to take advantage of supply chain big data, artificial intelligence and end-to-end visibility technologies that will bring benefits simply not possible today.

 

During the global deployment of Pharma serialisation/traceability over the last 15 years, much time and effort has been put into the development of the EPCIS standards to enable the frictionless flow of supply chain visibility information, but what exactly does it mean to be ‘compliant’ with EPCIS?

Does it mean ensuring the EPCIS messages you generate and receive conform to the EPCIS Schema and Core Business Vocabulary and conform to published guidelines from GS1 Member organisations?

Or does it mean that systems just work for getting data from point A to point B and hopefully loosely follow EPCIS?

And how do we measure and monitor this compliance?

Within your own organisation, are your system suppliers claiming their compliance is sufficient? Are the various EPCIS compliance/testing services adequate?

And what importance is the industry placing on being ‘compliant’ in any form?

In response to a global manufacturer wanting to evaluate their overall EPCIS compliance, Be4ward, supported by tools from their partner Jenneson, developed a four-level methodology focusing on:

- Technical adherence to the EPCIS standards
- Measuring risk associated with the proper/improper use of EPCIS for market regulatory compliance
- Best practice EPCIS design to enable future value opportunities from serialisation/traceability data

Our in depth compliance review allows you to take control of your own EPCIS compliance.

Contact us to learn how Be4ward’s approach can help you identify and mitigate foundational EPCIS data issues.

 

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.  

 

This year I once again had the pleasure of attending, chairing and presenting at the IQPC Pharmaceutical Packaging and Labelling Summit in Zurich on 18th and 19th June. Many thanks to Lucy Comer and the team at IQPC for organising the event.

I presented on the topic Managing Portfolio Complexity in Packaging – Dealing with Small Volume Products, looking at the growing challenge of complexity in packaging portfolios. As companies chase niche opportunities and products become more specialised, large volume packing runs are becoming increasingly rare. However, many pharmaceutical packaging facilities have been designed for higher volume product. Coping with portfolios dominated by small volume product significantly reduces operational efficiencies and drives a large hidden factory of support staff to maintain.

I reviewed some of the environmental factors causing this growth in portfolios and presented a three stage methodology to address the challenges of complexity. Firstly, the portfolio needs to be assessed and understood so that the characteristics and requirements of each SKU are clear. Secondly, sources of non-added value complexity need to be removed to standardise as much as possible. Thirdly, appropriate mechanisms, like postponement and late stage customisation, need to be introduced to provide the necessary complexity in a more effective manner. Finally, I reviewed the sorts of benefits in terms of efficiencies, lead times and costs savings that can be achieved by such a programme.

Other presentations from the event included:

The Role of Packaging and Labelling on Supply Chain Efficiency Prabir Das: Vice President – Packaging Development, Mylan

Prabir presented a broad overview of the interface between packaging and the supply chain. He talked about the commercial and environmental challenges facing packaging and how product characteristics impact packaging design and material selection. All of these issues should be addressed by the packaging system, which in turn should consider all of the requirements that need to be delivered by the packaging design. Prabir also talked about how packaging needs to protect the product, ensuring that the product is fit for use when it reaches the end-user. Finally, he looked at how technology will impact packaging in the future and what barriers will have to be overcome.

Evaluating the Use of Smart Packaging and Interaction with Smartphones Andrew Smith: Technical Packaging Director, GSK

Andrew presented on the use of smart packaging within the pharma industry. He discussed the benefits and opportunities presented by eLeaflets. Smartphone enabled leaflets permit the provision of enhanced product information, for example usage videos. Smartphones can also be used for alerts and compliance, security features and usage monitoring. This improves patient engagement and product security. Andrew reviewed the different types of technology that can be used as carriers to link to product information including tags, QR codes and barcodes. He highlighted the benefits and challenges of each technology and what potential application scenarios might occur.

Solutions to Optimise Your End-to-End Artwork Process Suzanne Ivory: Chief Operating Officer, Perigord

Suzanne presented on the challenges facing pharmaceutical artwork, particularly the impact on patient safety. She highlighted the need for clear processes with detailed instructions to ensure the desirable right-first-time outcome. The implementation of a comprehensive Quality Management System and the underpinning Artwork Management System are key capabilities to support the creation of correct artwork. She also discussed how the introduction of appropriate measures drives performance through focusing on addressing performance deviations. Finally, Suzanne discussed the areas of new technology emerging that will impact artwork processes and capabilities.

Ensure a Return on Your Investment by Implementing E-Labelling into Pre-exiting, Multi-functional Barcodes Tatjana Pathare: Senior Artworks and Regulations Specialist within the Serialisation Project, Roche and Christian Hay: Senior Consultant – Healthcare, GS1

Tatjana and Christian presented on the use of the serialisation barcode to provide a patient leaflet. They highlighted the opportunity of using GS1 Digital Link as the carrier for accessing the eLeaflet as it is an open standard platform. GS1 are now undertaking some pilots to develop this capability. Christian then followed up with a discussion on the ISO standard that is being drafted to support this use of the supply chain identifier to access digital information.

Digital Maturity Model for Packaging: Digitise, Automate and Connect in Pharma Simon Cavanaugh: Senior Account Executive – Global Business Group, ESKO and Steven Brookes: Solution Consultant, ESKO

Simon and Steve presented on the journey companies undertake to manage their digital assets in a comprehensive manner. As the volume of digital assets grows in a company, capabilities also need to evolve to manage assets effectively. ESKO has developed a roadmap tool to help companies with this journey. Simon also explained some of the different use cases they have witnessed for artwork introduction and reasons behind these process variations. Finally, Simon covered some of the other learnings ESKO have witnessed in client implementations, particularly around regulatory processes.

Maximise your Brand Engagement with Patient-centric Packaging and Understand How it Improves Patient Lives Gabriele Iannizzotto: Chairman, HCPC Europe

Gabriele presented on the work carried out by HCPC Europe and the annual Columbus Award for patient safety packaging. He discussed some of the numerous issues facing patients, which can be resolved through improved packaging design. He then introduced some of the previous winners of the Columbus Award demonstrating some of the patient safety / adherence features they included.

What’s Holding Us Back? Identify your Supply Chain Bottlenecks and Risks Jeffrey Hardy: Director General, TRACIT and Suriya Prabha Padmanaabhan: Director of Programs, TRACIT

Jeff and Suriya led a discussion on the issues attendees are witnessing with illicit trade across their supply chains. They looked at each step of the supply chain defining key issues, causes and impacts. This is part of a wider survey they are undertaking across many industry sectors. The outcomes will be captured in a cross-functional business report on illicit trade.

Challenges for Global Pharma Companies to Implement Anti-counterfeit Strategy for Russian Track & Trace Regulation Dr Ettore Cucchetti: Chief Executive Officer, ACG

Ettore presented on the development of secure supply chains across various industry sectors and territories. He compared the maturity of security activities in life sciences against other sectors and examined how capabilities are likely to develop in the life sciences sector. Ettore also discussed each of the elements required for a full product traceability solution.

Putting Patient Safety at the Heart of FMD Leyla Hannbeck: Chief Pharmacist & Director of Pharmacy, National Pharmacy Association

Leyla presented on the patient safety issues associated with packaging and FMD, as witnessed in pharmacies. In particular, she highlighted the significant amounts of 'look-alike, sound-alike' errors that happen and how improved packaging design could alleviate these. She presented a number of case studies highlighting the issues where dispensing errors had occurred. Leyla also discussed the impact of FMD on community pharmacies and the preparation activities that have been undertaken to date.

Serialisation and the Future of Hospital Pharmacy Robert Moss: Director of Professional Development, European Association of Hospital Pharmacists

Robert presented on the impact of serialisation and other technological developments on hospital pharmacies. He discussed the problem of identifying the point of authentication in a hospital pharmacy. There are a number of points within the hospital environment where is could be carried out from goods receipt to patient use and each presents challenges. Regarding other technological developments, Robert explained how aggregation would have a significant benefit to hospitals by avoiding having to scan each pack in a case. Scannable single dose primary pack barcoding provides significant patient safety benefits, and EAHP have been advocating this for a number of years. Finally, Robert showed some of the automated drug dispensing and delivery equipment that is being developed.

Fulfilling the Needs of the Local Market with Need-based Packaging Innovation Rajesh Mishra: Associate Director – Packaging Development, Abbott

Rajesh presented on the challenge of designing products to meet local market needs. Focusing on India, he highlighted some of the issues created in a market that is high volume but low cost, with a very high degree of competition. In this environment, needs-based innovation is key to defining how to differentiate your product. Rajesh showed a few examples of packaging design that were developed to meet these challenges. He highlighted a key learning which was making sure that the design of the pack or device was easy to understand and use across many different demographic groups.

EU MDR and its Implications for Labelling and Artwork Karolina Komposh: Labelling and Artwork Manager, Croma-Pharma

Karolina presented on the new Medical Device Regulations. She provided an overview of the regulations, some of the major changes that have been introduced and the timelines to be achieved. She then explained some of the issues that are being discussed between industry and the regulators. As can be expected by such a large piece of legislation, there are many details that need to be further worked to develop practical solutions and time pressures are making these issues more acute.

End-to-End Solution for Managing Labelling and Packaging Artwork Ray Collia: Senior Account Executive, Loftware

Ray presented a clinical trials artwork case study on an implementation undertaken by Loftware. He outlined some of the challenges in clinical trials that can impact the development of clinical trial artwork. He also gave an overview of the business issues that the case study company were wanting to address. He highlighted the benefits that can be delivered through a suitable labelling and artwork system and explained key features of the Loftware system.

Preparing for the Worst : Negotiating with Sites That Have Not Prepared for FMD and Anticipating Brexit Huda Awidi, Regional Regulatory Affairs Manager – Labelling & Artworks – Middle East, Africa, Turkey & Pakistan, Mundipharma

Huda presented on the impact of Brexit and FMD on Middle Eastern / African countries. This is a complex range of countries with many local requirements. She covered the actions being taken to prepare for potential Brexit scenarios which will impact many things including, for example, product licenses due to changes to sites of release. Huda also discussed the implementation of FMD. There is a strong pull in the countries she represents for a serialisation solution, due to the levels of counterfeit product, but countries are at different levels of development. Products are supplied from 60 CMOs so agreeing processes and procedures is difficult. As some countries are implemented and some are not it has also made it difficult to share packs. Finally, Huda explained the methodology they have used to implement serialisation across the region and highlighted key learnings from their implementation.

Morning Workshop: From Manufacture to Use: Overcome the Challenges Encountered during the Three Stages of the Packaging Lifecycle Prabir Das: Vice President – Packaging Development, Mylan

Interactive Workshop: Moving Beyond Compliance – Transitioning from Serialisation to Securitisation Mark Willis: MDR and Compliance, Johnson and Johnson

In addition to the presentations by the speakers above, Prabir and Mark held workshop sessions on the Packaging Lifecycle and Transitioning beyond Serialisation respectively.

It was a pleasure to chair such an informative and engaging two day event, tackling a wide breadth of topics, many of which are constantly evolving as the Pharma Packaging and Labelling landscape responds to many wider industry changes. Thank you to all the speakers and attendees for making a productive and enjoyable session. I look forward to meeting again next year.

Be4ward is a niche consultancy company helping pharmaceutical, biotech and medical device companies and their supply base improve their serialisation, labelling and artwork capabilities. We help clients define the most efficient business processes, organisation design and, being completely independent, help them select and implement the most appropriate service providers and IT systems to meet their needs. Be4ward helps these companies improve patient safety and drive additional value from their product range.

Should you have any questions or would simply like to request a copy of my booklets, please don’t hesitate to contact me directly on my email [email protected]

For more information on our areas of expertise, go to our free download section.

I had the opportunity to attend, chair and present at the IQPC Pharmaceutical Packaging and Labelling Summit in Zurich on 18 - 20 June. Many thanks to Katherine Gordon and the team at IQPC for organising the event.

I presented a mini-workshop on How to Identify the Steps to Provide a Comprehensive Artwork, Labelling & Packaging Service. In the workshop I explored the impact of portfolio growth and complexity on artwork, packaging and labelling teams. I focused on what capabilities you might introduce to meet the challenges of growing product portfolios. I also looked at how to engage your organisation to make necessary enhancements compelling. Finally, I explored how to ensure you deliver successful outcomes.

I also hosted an interactive round table discussion, Global Regulatory Deep Dive – Identifying Similarities and Differences Across Key Market Requirements. I focused on analysing the global regulatory landscape – how black market trade and product counterfeiting threatens the supply of pharmaceuticals across borders. I also looked at how to ensure market compliance by identifying key international areas of regulatory similarity to exploit and differences to prepare for ISO 21296 – looking towards the new international standard on Tamper Verification techniques.

Other presentations from the event included:

GS1 Standards - A Toolkit for Fighting Against Pharmaceutical Counterfeiting
Tania Snioch, Director Healthcare, GS1 Global Office

Tania introduced the role of GS1 and how GS1 standards underpin serialisation and traceability. Tania explained how GS1 works with partner organisations through the Joint Initiative Council.

Tania also discussed the impact of counterfeit drugs in developing countries. Tania also highlighted the benefits of standardisation to hospitals and their supply chains. Finally, Tania outlined the regulatory requirements for serialisation and traceability across a number of countries that are legislating solutions.

Let's Dream Big! Clearly and Quickly Connect with Patients and Consumers Through Packaging and Labelling Artwork
Simon Cavanagh, Account Executive Brand Solutions, and Steven Brookes, Pre-Sales Solution Architect Brand Solutions, Esko

Simon and Steven talked about the digitalisation of packaging tools and packaging design, and how this will change the approach to packaging design in the future. Simon and Steven also gave an overview of Esko’s tools, the enhancements that Esko have been working on, and how they address the growing challenges brought on by digitalisation.

Solutions to Optimise your End-to-End Artwork Process
Suzanne Ivory, Global Quality Director, Perigord

Suzanne talked about how artwork fits into the overall end-to-end labelling process. Suzanne discussed key drivers for change that are impacting labelling and artwork including product proliferation, data security and an increased focus on pharmacovigilance. Suzanne distilled this down to the key challenges to artwork and the solutions required to meet them. These included the need for a quality management system, an artwork management system and carefully selected long-term partners.

Anti-Counterfeiting Requirements with a Focus on Non-EU Areas
Horst Kastrup, Senior Regulatory Advisor, MEDA Pharma (retired)

Horst presented on anti-counterfeiting requirements, particularly outside of the EU. Horst highlighted the magnitude of counterfeit products in low to medium income countries, particularly antimalarials, with estimates of 1 million deaths per year due to counterfeit products.

Horst discussed several case studies across a number of products and countries. Horst also outlined the various regulatory requirements that have been introduced to address this.

Implementing Child Resistant Packaging Without the Tantrum
Stephen Wilkins, Chairman, Child-Safe Packaging Group

Stephen presented on the requirements for child resistant packaging and the background reasons for these requirements. Stephen provided an overview of the various regulations and standards. Stephen showed a number of failure modes and some examples of good practice.

Stephen also discussed the impact of packaging design on the elderly, which can be detrimentally impacted by child resistant features.

Purchasing for Patient Safety - Payer's Influence on Assessment of Packaging & Labelling for UK NHS Hospital Formularies
Omar Ali, Formulary Development Pharmacist, QIPP Advisor Payer Network and Former Formulary Advisor, UK National Health Service (NHS)

Omar’s presentation covered the role of packaging in patient safety. Omar talked about the environment of medication errors and the impact on patients and healthcare professionals. Omar showed the impact of similar product names and discussed potential systems solutions e.g. electronic prescribing tools.

Omar then looked at labelling issues and what was needed to resolve them. Referring to the NPSA guide to packaging design, he showed how layout and colour can be used to help highlight specific product issues.

Overview of the FMD Challenges and Opportunities for Hospital Pharmacies
Robert Moss, Board Member & Director of Professional Development, European Association of Hospital Pharmacists

Robert discussed the implications of FMD on hospital pharmacies. Robert looked at the hospital supply chain and the issue of when the product should be authenticated within the hospital. This is a complex issue for many hospitals where they are integrated with other healthcare facilities.

Robert then discussed the other issues presented by FMD on hospital pharmacies. This included the impact on pharmacist capacity and workload, processes for product rejection and return, and impacts on cold chain product.

BfArM Pharmacovigilance Inspection - Case study from a labelling point of view
Hannah Hähl, Regulatory Affairs Manager (Labelling), Grunenthal

Hannah presented on the learnings and improvements made to Grunenthal’s labelling process following inspection observations. Hannah gave an overview of the inspection process and activities. Hannah then discussed the need for more end-to-end oversight of safety variations and the introduction of a tracking tool and other process improvements they have undertaken. Hannah highlighted that regulators are increasingly looking for end-to-end oversight that safety changes are implemented in a timely manner, but that inside a company, implementation can mean different things.

Case Study - Improving Artwork Process Efficiency on a Global Scale
Russell Collins, Director, Packaging Strategy and Global Labelling Business Process, AstraZeneca and Paul Goldberg, Vice President of Product Strategy, Loftware

Russell and Paul presented on the improvements that AstraZeneca have been undertaking and the implementation of Loftware’s artwork management system. Paul gave an overview of Loftware, the acquisition of Gap Systems and how their product offering will evolve. Russell explained AstraZeneca’s process maturity development model and how their capability improvements have been prioritised. They are now at the stage of considering how the labelling and artwork process will be seamlessly integrated into the overall company process architecture.

Russell showed how the improvements they are making are aligned to the company’s goals and the benefits these improvements will deliver. Russell emphasised the need to focus on improvements that clearly support business requirements.

The Trials and Tribulations of a Labelling Professional
Keith Howard, Former Senior Labelling Manager, Vertex Pharmaceuticals

Keith discussed the issues faced by Regulatory and Labelling professionals. Keith walked through the life of a typical change, highlighting the issues that can arise in execution. This showed the amount of variability that can arise in the process due to different problems that can occur. Keith also emphasised the need for collaboration across and outside of the company. Regardless of the application of artwork management systems, there are still a high degree of people involved and many issues arise due to differences in opinion. Someone needs to be accountable to resolve these issues and ensure changes are delivered on time.

Increasing therapy adherence through packaging: Designing packaging that improves patient's lives
Ger Standhardt, Executive Director, HCPC Europe

Ger presented on how packaging can improve the life of patients. Ger explained the remit of HCPC Europe and the purpose of packaging. Using examples of HCPC Europe Columbus award winners, he highlighted features on packaging that improve patient adherence. These include; calendarisation, portability and discreteness, child resistance, ergonomics and provision of usage information.

How to Prepare For Delivery Of The FMD On Time And Final Considerations To Be Made
Johan Verhaeghe, National Policy Liaison, Medicines for Europe

Johan discussed the FMD regulation deployment. Johan outlined; the FMD regulations, explained the European Stakeholder model, the European Hub and national systems, and the roles of the different participants. Johan then explained that deadlines are imminent and there is still much work to do in many organisations. Country preparations are progressing but there is a concern that some may be late.

Be4ward is a niche consultancy company helping pharmaceutical, biotech and medical device companies and their supply base improve their serialisation, labelling and artwork capabilities. We help clients define the most efficient business processes, organisation design and, being completely independent, help them select and implement the most appropriate service providers and IT systems to meet their needs. Be4ward helps these companies improve patient safety and drive additional value from their product range.

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 directly on my email.

For more information on artwork, go to our free download section.

The new EU Medical Device Regulation and In Vitro Diagnostic Regulation are here and companies need to be deciding how they will address them. Approved by the European Parliament in May 2017, these new regulations are the biggest change to the legislative framework for medical device and in vitro diagnostic products in decades. As discussed in my previous blog on the subject, one aspect of this new legislation is the requirement to appoint a Person Responsible for Regulatory Compliance. This requirement has an impact on manufacturers and authorised representatives supplying medical device and in vitro diagnostic product in the EU market. Companies will need to implement many new or enhanced capabilities to meet these obligations.

For companies faced with these challenges, it begs the obvious question ‘So where do we start?’

Define your strategy
The logical first step is to define the company’s strategy for how to tackle the new regulations. Typically, strategy development would include:

1. Understanding of the current and new legislation.
2. Impact of the legislation on the company's operations, including any opportunities that might present.
3. A gap analysis of each relevant aspect of the company’s operations against the requirements of the new legislation.
4. An assessment on existing and pipeline product registrations, testing and labelling.
5. Initial high level designs of potential new processes, capabilities and IT solutions.
6. High level roadmap for re-registrations, testing or re-labelling and implementing new processes, capabilities and IT solutions.
7. Cost and resource impact estimation.
8. Plan for the next phase of activity.

Some considerations when defining your strategy
From our experience of delivering large and complex legislative-driven change, there are a number of things to think about when defining your strategy:

Take a cross functional approach: The impacts of the regulations are cross-functional so make sure that you have all relevant functions involved in defining your strategy. Avoid the temptation to ‘slice and dice’, allowing each function to independently develop their approach. The company needs a holistic response so develop your strategy as a true cross-functional activity. All stakeholder groups involved in the delivery of the legislation need to contribute effectively or the whole process is at risk of failure. Therefore, all parties must buy into their roles in the processes and actively contribute to them. This will rarely happen if they are simply passive bystanders in the design of the capabilities or the delivery of the resulting activities.

Define and agree some governing principles: Providing guidance to the team on what would be permissible or not, defining the ‘rules of game’ to all parties. This provides a boundary and decision-making framework for solutions being developed and should be approved and managed by the governance team.

Ensure effective cross-functional governance: Given the cross-functional and cross-organisational nature of the regulations, establishing the right inclusive leadership and governance is key to the long-term success of the activity. A cross-function governance team should therefore be established to steer the definition, establishment and ongoing delivery of your strategy. This governance body should include membership from all the stakeholder groups involved.

Build in flexibility: The implementation of solutions to address new legislative drivers is complex, not least because through the implementation journey, the legislation evolves.  Unforeseen situations and challenges will arise, timelines may change, Delegated Acts may introduce further local requirements. Therefore, solutions defined need to have sufficient flexibility to cope with further emerging requirements. This is not easy, but is a key challenge of which solution design teams must be made aware.

Look for standard approaches: In large and complex operations, it may be necessary to implement solutions at multiple locations. It can therefore be beneficial to develop standard approaches for solutions that can be replicated at each of these locations rather than ‘re-inventing the wheel’ at each one. This provides two benefits – it can be more efficient in preparing the solutions and learnings across the organisation can be shared. However, if taking this approach, local requirements must be highlighted and built into the developed solutions.

Put a capable, dynamic and motivated leader on the problem: These regulations are complex and evolving, touching many parts of an organisation. With the challenges facing the leadership that is charged with implementing such capabilities, they need to have a broad range of skills, the drive and motivation to anticipate risks and issues, as well as ensure they are effectively managed proactively. Furthermore, there will be many technical challenges to address so the leadership of the program needs to have the technical strength and breadth to succeed in managing these.

Involve local country teams and management early: Good change management practice encourages the involvement of those impacted early in the activity. The local country teams will be key in supporting implementation and ongoing operation of solutions implemented, as well as undertaking a significant role in product re-registration and labelling updates. Involving them early will ensure solutions are fit for purpose and that they buy into the activities you need them to do.

Refresh your strategy as appropriate: The implementation of the new regulations will take many years and requirements will probably evolve. The environment you operate in and your company will likely change in this time as well. Your strategy is therefore not a one-time activity. It needs to grow and evolve as the surroundings change. Hence you need to build in regular reviews of the strategy to ensure it remains pertinent and comprehensive.

Your strategy will help you chart your course
As can be seen from the above, developing your strategy is a key point in your journey to address the issues presented by EU MDR/EU IVDR. It will help your company understand what needs to be done and how resources will be marshalled to address those challenges. The strategy processes need to be timely, giving enough time to undertake the strategy process itself effectively but also giving enough time to subsequently implement the new requirements, and it is an ongoing process tuning the company’s response as situations change. Appropriate flexibility and risk mitigation needs to be built into your solutions and deployment plans. A good strategy will help facilitate a successful response to the legislation across your organisation.

If you are impacted by EU MDR / IVDR, start planning how to transition to the new requirements and avoid supply interruptions. Our Executive Briefing, An Introduction to the EU Medical Device Regulation (EU MDR) can help you understand the legislation and develop a strategy for transition.

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

Be4ward is proud to sponsor Making Pharmaceuticals UK Exhibition and Conference this year. The event will take place April 24 – 25, 2018, at Ricoh Arena, in Coventry, UK. We hope to see you there.

The team at Be4ward will take the opportunity to present at the event. Neil Wetherall, Consultant, will be speaking on April 25, at 14:00 in Room A. Neil Wetherall will focus on the EU Falsified Medicines Directive –An Update on the Latest Status and Key Learnings From Implementation. I will also be speaking on April 25, at 15:00 in Room A. I will focus on the EU Medical Devices Regulations – An Update on Latest Status and Implications for Combination Products.

This event is proudly sponsored by Be4ward and will be attended by Be4ward.

For more information, follow the link to the event organiser website.
Making Pharmaceuticals UK

Be4ward is a niche consultancy company helping Pharmaceutical, Biotech and Medical Devices companies and their supply base improve their serialisation, labelling and artwork capabilities. Be4ward help clients define the most efficient business processes, organisation design and, being completely independent, help them select and implement the most appropriate service providers and IT systems to meet their needs. Be4ward helps these companies improve patient safety and drive additional value from their product range. Corporate website: www.be4ward.com Contact: [email protected]

Be4ward is proud to sponsor Making Pharmaceuticals Europe Exhibition and Conference this year. The event will take place March 13-14, 2018, at Brussels Expo, in Brussels, Belgium. This event will be attended by Be4ward and I will be taking the opportunity to present. We hope to see you there.

The team at Be4ward will take the opportunity to present at the event. Andy Cumming, Consultant, will be speaking on March 13, at 11:30 in Room B. Andy Cumming will focus on the EU Falsified Medicines Directive –An Update on the Latest Status and Key Learnings From Implementation. I will also be speaking on March 13, at 12:10 in Room B. I will focus on the EU Medical Devices Regulations – An Update on Latest Status and Implications for Combination Products.

For more information, follow the link to the event organiser website.

 

Be4ward is a niche consultancy company helping Pharmaceutical, Biotech and Medical Devices companies and their supply base improve their serialisation, labelling and artwork capabilities. Be4ward help clients define the most efficient business processes, organization design and, being completely independent, help them select and implement the most appropriate service providers and IT systems to meet their needs. Be4ward helps these companies improve patient safety and drive additional value from their product range. Corporate website: www.be4ward.com
[dt_sc_email emailid="[email protected]"/]