Today I read about falsified COVID-19 vaccines being identified in the Islamic Republic of Iran.  This demonstrates that the fight against fake medicines is ongoing and serves as a timely reminder about the risks being faced by patients.

Medical Product Alert N°7/2021: Falsified COVID-19 Vaccine AstraZeneca (who.int)

Medical Product Alert N°6/2021: Falsified Pfizer-BioNTech COVID-19 Vaccine (who.int)

Why was this so timely . . . ?

Only yesterday I had the privilege to join a panel at the GS1 Healthcare 3rd Online Summit.  The session focused on the progress being made in Africa, on the journey towards Healthcare Supply Chain Traceability.

The session chaired by Tom Woods, Global Steering Committee for Quality Assurance - World Bank, highlighted the progress being made in countries such as Nigeria, Ethiopia, Zambia, and Rwanda.

Also included was a presentation of the Verification and Traceability Initiative, which is supporting countries to reduce the urgent risk of falsified and diverted health products.  Initially focused on COVID-19 vaccines, the initiative has a vision of working towards national traceability of all vaccines, medicines, and health products.

UNICEF and its partners (USAID, Gavi, The Global Fund, The World Bank, Bill & Melinda Gates foundation) provided an overview of the repository, currently being set up, which will allow the verification of COVID-19 vaccines, using GS1 standards.

Whilst systems alone will not fully address the risks, when combined with other interventions, such as destroying used vials and packaging after use, we can make a difference in the fight against fake healthcare products.

One of my takeaway thoughts, having participated in the Summit, is that we are now at the start of the next wave of countries which are embarking on their journey towards Healthcare traceability.  There is also a tremendous drive by these countries to deliver the benefits which we have seen in places such as Argentina, Turkey, and the European Union.  We must support these countries and use the knowledge and experience gained over the past ten years of traceability deployment to help them be successful.

There is no doubt that we are going to see more Lower Middle Income Countries (LMICs) adopting GS1 standards to increase supply chain visibility and secure the supply chain.  We must all do our part to support these countries on their journey towards traceability, to ensure we protect every patient from fakes.

Grant Courtney

Principal Consultant - Be4ward

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 8th Annual Pharmaceutical Packaging and Labelling Summit is taking place on the 18th - 20th June 2018 in Switzerland. I will be chairing this event. Key challenges will be addressed, surrounding:

I will be presenting a mini-workshop at this event on, How to Identify the Steps to Provide a Comprehensive Artwork, Labelling & Packaging Service. This workshop will explore the impact of portfolio growth and complexity on artwork, packaging and labelling teams. I will be focusing on:

I will also be hosting an interactive round table discussion, Global Regulatory Deep Dive – Identifying Similarities and Differences Across Key Market Requirements. I will be focusing on: