EU Automation: Digitally securing the pharmaceutical supply chain
Errors in the pharmaceutical supply chain can lead to late delivery, increased costs and poor quality products, which can have a detrimental impact on consumers. Due to current trends changing the way the pharmaceutical industry operates, supply chains are becoming more complex, making it more important than ever to streamline operations. Here, Jonathan Wilkins, director at automation parts supplier EU Automation, explains how organisations can use digital technologies to improve the pharmaceutical supply chain and minimise the risk of errors.
In 2009, consumers of the pain reliever Tylenol reported a musty odour, requiring Johnson & Johnson to make numerous large recalls. It was eventually found that wood pallets used in shipment were causing the problem. The pallets had been treated with a fungicide that had decayed into a chemical that was causing the odour, as well as gastrointestinal adverse effects. The recall cost Johnson & Johnson $900mn and the damage to the Tylenol brand will never be fully repaired.
There are four trends making it increasingly challenging for pharmaceutical organisations to prevent supply chain errors like that of the Tylenol scandal. However, organisations can implement digital technologies to improve supply chain operations and ensure consumers receive a high standard of healthcare and safe and effective medications.
The pharmaceutical industry has been much slower to globalise than other industries, with high-income countries still dominating production and consumption. However, with many clinical trials now operating globally, including in developing countries, and many developing countries increasing their healthcare budgets, pharmaceutical supply chains are gradually globalising.
Often, a drug’s active pharmaceutical ingredient (API) will be manufactured by one contract manufacturing organisation (CMO), incorporated into the final dosage form by a second CMO and packaged by a third. It is becoming increasingly common for these CMOs to be in different countries.
Despite the increasing costs and complications caused by the globalisation of pharmaceutical supply chains, customers are expecting faster deliveries than ever before. Therefore, efficient transport, effective tracking and stringent quality control are becoming even more important.
According to a recent report by the Access to Medicine Foundation, one of the major causes of antibiotic shortages is a lack of visibility in the supply chain. Organisations can increase supply chain visibility using cloud technology to ensure real-time sharing of secure data. The cloud can be accessed by any authorised person, regardless of their location, so geographical boundaries are not a hindrance.
Augmented reality (AR) and virtual reality (VR) technology can also make it easier to work with people in other countries. The technology allows workers to visit sites overseas, whether for a meeting, a conference, to provide training or to observe the equipment and operations, without having to travel. If workers do not have access to AR or VR technology, there are several video conferencing platforms, such as Skype, that can be used to participate in meetings, share screens and send files in real time.
Despite the ease with which colleagues can collaborate overseas, it is still important to meet in person occasionally to maintain strong relationships. Technology can still be used to streamline the process — mobile phones, laptops, tablets and portable Wi-Fi hotspots make it possible to work while travelling.
It takes an average of three years from submitting a drug to the Food and Drug Administration (FDA) or European Medicines Agency (EMA), to the drug reaching a patient. This is not fast enough for personalised medicine — patients with serious illnesses often cannot wait three years for a suitable drug. Therefore, the supply chain for personalised medicine must be rapid, without negatively impacting product quality or regulatory compliance.
Investments in automation systems will be vital for speeding up the supply chain for personalised medicines, while ensuring the level of precision required for patient safety is achieved consistently. At Hannover Messe in 2017, Siemens demonstrated how automation can be used to design a manufacturing environment that makes personalised medicine more commercially viable. To help automation technology find its way into the personalised medicine industry, Innovate UK has up to £6mn to invest in technology that will help businesses to understand and meet the challenges involved in developing personalised medicines.
However, a fully digitalised factory is a big shift for most manufacturers, requiring rapid change. To make the process more cost-effective, manufacturers can make existing equipment smarter by retrofitting, as well as implementing new equipment.
Forecasting demand for personalised medicines is much more challenging than with traditional medicines. Production must be timed with prescribing, which means demand driven manufacturing resource planning and just-in-time (JIT) schedules will become more important. Organisations should make greater use of data, such as epidemiology information, genetic analysis and insight from wearable wellness trackers, to make predictions about demand and ensure sufficient and timely supply.
Personalised medicines are specific for individual patients and if the wrong patient receives the wrong drug, the consequences can be severe. Therefore, traceability along the supply chain is extremely important. Automated manufacturing lines can be equipped with radio-frequency identification (RFID) technology, to track and trace products during manufacturing, packaging and delivery. Radio waves can also be used to communicate information between a reading device and a product.
The global biologics manufacturing market is expected to show a compound annual growth rate of over nine per cent between 2018 and 2022, according to a recent market research report by Technavio. To be prepared for this growth, pharmaceutical supply chains should adapt to the additional requirements of biologic drugs.
The stability of biologics is complex because they are made from living organisms or contain components of living organisms. They often degrade by multiple pathways and these pathways may vary at different stages of shelf life. Also, many biologic drugs contain proteins, which can undergo slight structural changes in response to stresses such as temperature excursions. Slight protein structural changes can have large effects on the therapeutic properties of drugs. To make sure biologics are safe for consumption when they reach patients, the supply chain must be fast and physical conditions along the supply chain must be tightly and consistently controlled, to minimise degradation and structural changes.
Often, biologics require cold chain transport and storage, usually between two and eight degrees Celsius. Improving the cold chain capabilities in the supply chain requires a huge network of time and temperature sensors in factories, warehouses, trucks, labs and pharmacies.
Generally, temperature control is greater at earlier stages of the supply chain. Every drug has a label claim, which provides stability information. As drugs begin their journey through the supply chain, the manufacturer starts the clock by shipping full trailers of products with the same label claim. However, when the products reach wholesalers, pallets are broken up and products are comingled for distribution with others, meaning label claims become mixed. To make sure supply chains are temperature controlled in their entirety, the industry should pay close attention to improvements at the wholesaler stage.
FedEx’s TEMP-Assure portfolio maintains pharmaceutical products at consistent, required temperatures. When bad weather delays a shipment, the company moves the products into in-transit, temperature-controlled storage, to minimise the impact of the delay on the properties of the products. The company’s supply chain visibility system SenseAware comprises multiple sensors that monitor the temperature of containers in transit in real time. It indicates whether a shipment has been opened or subjected to light, humidity or sudden movement and tracks the entire supply chain.
Delta Cargo has also introduced digital technologies to ensure temperature control in the pharmaceutical supply chain. It has equipped its warehouses with temperature-calibrated coolers and uses thermal mapping to ensure the temperature remains consistent throughout storage containers, vehicles and rooms.
There are also biochemical technologies that could improve the biologics supply chain. A collaboration between StoneStable, a start-up in Oregon, US, and Portland State University is investigating improved ways to transport vaccines, a type of biologic drug comprised of viruses. The team is experimenting with coating viruses in silica, which renders them inert and resistant to hot and cold temperatures, and then returning them to their original state prior to consumption. This would allow vaccines to be transported at room temperature safely, which would reduce supply chain costs and the number of products discarded due to temperature excursions.
The World Health Organisation (WHO) recently estimated that one third of all medicines sold worldwide are counterfeits. As well as damaging the reputation of pharmaceutical companies and causing them a loss of revenue, counterfeit medicines can cause considerable harm to consumers if the ingredients are not the same as those of the genuine product. This has been demonstrated in Sub-Saharan Africa, where counterfeit malaria pills have been responsible for an estimated 116,000 deaths a year.
The prevalence of counterfeit drugs is expected to increase as global costs for healthcare increase and technological advancements make it easier to make exact copies of drugs and their packaging. Fortunately, there are several technologies that can help protect pharmaceutical products against counterfeiting. A common approach is to package drugs with a barrier to entry, which, if breached or missing, indicates that tampering has occurred. Examples include film wrappers, shrinkable seals and bands, breakable caps, tape seals and blister packs. The disadvantage of this approach is that the barriers are easy to mimic.
More advanced technology can provide greater protection against counterfeiting. For example, holograms can combine three layers of security features that show a product is legitimate. Embedded images, digital watermarks and invisible printing are also effective, because they require regulatory approval so are challenging to replicate. Also, chemical and biological tags can offer highly secure authentication, but are more expensive than other options and more challenging to implement.
The FDA recommends pharmaceutical manufacturers use multiple, periodically changing authentication measures on a product specific-basis, to provide the best possible protection against counterfeiting. This may involve physical barriers like blister packs, as well as holograms for first line authentication, in addition to covert features like scrabbled images, microtext or UV-sensitive inks for second line authentication.
Since 2009, the capabilities of technology have increased dramatically. This has given companies like Johnson & Johnson the opportunity to improve their supply chains, so that crises like that of the Tylenol brand do not happen again. For more information about how to digitalise your supply chain, visit https://www.euautomation.com/.