After a long period of industrialised economies’ domination of the pharmaceutical market, the emerging countries are outgrowing their developed peers. The rapidly growing demand for medicines in Africa, Asia and Latin America (dubbed as “pharmerging economies” by IMS Health)1 is a fact that has to be addressed by the packaging industry. Creating packaging that will resonate in the local market is critical to success in emerging markets. This is driving innovation in packaging, and in turn coding and marking technologies, presenting pharmaceutical manufacturers with more options than ever. However, a successful global pharmaceutical expansion strategy is built on a foundation of best practices that will help ensure products are safe to use for patients across the globe.
Alongside their increasing economic wealth is a notable rise in healthcare spending among emerging markets. Investments in the healthcare system, made by government, non-governmental organisations (NGOs) and the private sector are fuelling the growth of the pharmaceutical market. The combination of strengthening economies and an expanding middle class is the main stimulator for pharmaceutical expansion. By 2016, pharmaceutical spending in Asia Pacific is expected to grow at a 12.5% compound annual growth rate (CAGR) to 2016, followed by Africa at 10.6% and Latin America at 10.5% over the same period.2 At the same time the developed markets of North America, Europe, and Japan will see more modest single-digit spending growth between 2014 and 2017 (Source: IMS Health)3. The global focus on pharmaceutical expansion in emerging markets is driving an urgent need for global serialization and traceability, to secure both supply chain integrity and patients’ safety.
Coding is fundamental
With total global spending on medicines projected to reach over $1 trillion by 2017 (Source: IMS Health)4, the demand for standardised serialisation of pharmaceutical packaging becomes a crucial matter. At the moment, most industrialised economies are strengthening their legislation relating to preventing falsification of pharmaceutical packaging and protection of patients’ safety. It is a $7 billion problem for the pharmaceutical industry with thousands of packaging lines needing to change. Yet without precision coding and marking technology, serialisation efforts will be ineffective and, in worst cases, can lead to costly product recalls and potential fines. Therefore pharmaceutical packaging manufacturers investing in “pharmerging” markets have to be aware of the challenges lying ahead and secure their business by implementing the latest coding and marking technologies.
Pharmerging packaging growth
Correct product coding is vital for pharmaceutical packaging manufacturers – large and small – interested in the emerging markets. The latest technologies available on the market enable companies to embrace more innovative packaging solutions by expanding their product portfolio, both in the range of materials used and in production efficiency. For example, blister packs are the fastest growing package type in pharmerging markets due to product protection, patient compliance, and support of daily and weekly dosages.
Currently, coding technologies are applied primarily on secondary packaging (e.g. cartons), but the market is expressing a growing interest in coding on primary packaging, such as blisters. As such, a range of printing solutions is now available to code both types of packaging, however, manufacturers need to consider the substrate characteristics and available print area first when selecting the right technology. Substrate characteristics as well as uptime and code resolution requirements can all have an impact on which printing solution is optimal for a given serialisation initiative.
Successful printing for track and trace
After ensuring appropriate printing capabilities, the next step is capturing product information (such as device and production identifiers) so the package can be tracked throughout the supply chain. Stable product control is vital to avoid false rejects. Two different methods are considered best practice: integrating the print & inspect system directly into the cartoner or through a dedicated transport system.
A complimentary strategy is required to manage the vast array of product information created throughout the supply chain. This can be achieved through aggregation, where unique codes are created on outer packaging that is linked to all the units within. Aggregation avoids the opening of cases and scanning while the products are moving across the supply chain. Downstream in the supply chain, when a case or pallet code is read, an inference is made that all the individual units linked to the outer case are contained inside. Obviously this makes code quality and data integrity paramount.
In order to aggregate cartons/bottles into cases, the serial number reading should be coded at the last possible moment, preferably once the product is already inside the case, to guarantee data integrity.
Finally, the manufacturer should use authoritative data sources, such as manufacturing execution systems (MES), supervisory control and data acquisition (SCADA), enterprise resource planning (ERP) or similar. This way the company ensures that proper information is pulled to the printer automatically when the job is selected. According to a UPS report (Pain in the Chain, 2013), 56% of healthcare companies have found that IT investments, including bar coding and e-pedigree technology, have helped them to successfully address product security.
Flexibility is the key
Since the global track and trace serialisation regulations are evolving constantly (including Latin and North America, South-East Asia and Europe), careful consideration of the local market is key to success. Pharmaceutical packaging manufacturers must invest in a printing solution capable of addressing today's and tomorrow’s regulatory demands, as well as specific local needs. Given the rapid growth and uncertain regulatory future, the chosen printing solution should be flexible to make the producer’s life easier. Ideally, your technology provider will offer an operator-friendly standard interface compatible across printing technologies that can simplify user experience regardless of technology. As 50-70% of coding errors result from incorrect data entry, a centralised message management removes the task of message creation from the line, and helps ensure the right codes get on the right products. Therefore the right printer can be a productivity driver in the face of growing complexity of global pharmaceutical market.
Author:
Richard Nemesi is Global Vertical Marketing Manager for Pharmaceutical and Medical Devices at Videojet Technologies. His main responsibilities at the company are to develop a deep understanding of global trends and customers’ needs within the sector, create marketing content to support sales efforts and provide counsel to product development teams on equipment functionality. Prior to Videojet, he was a Systems Sales Specialist in the Systems and Technology Group at IBM.
1. www.quotidianosanita.it/allegati/create_pdf.php?all=6540948.pdf (Page 15)