Over the past 50 years, globalisation has, for better or worse, dramatically altered the way everyone lives, trades and communicates. Despite its critics, there is no doubt that becoming increasingly interconnected has also benefitted the human race: it has facilitated speedier economic development, brought accountability to governance, and meant feats that were once impossible are now achievable.
For the pharmaceutical industry, globalisation has opened up possibilities that were previously unthinkable. Scientists can more easily collaborate and share their findings from anywhere in the world, and manufacturers can develop and produce medicines used by patients thousands of miles away soon after coming out of the plant. But the transportation of these products is a major challenge. The growing complexity of innovative drugs is reflected in their increasingly diverse and intricate supply chain.
"Time and coordination is the key to moving a shipment efficiently," says Andrea Gruber, manager of cargo business, process and standards at the International Air Transport Association (IATA). "Any delay in the shipment can have consequences, especially if the cargo is perishable. Temperature control in shipment is an important component of the industry and is continuously rising in line with international trade."
Pharma transportation
Pharmaceutical air freight is set to grow far faster than even the most popular air cargo, consumer electronics. Over the next five years, pharmaceutical shipments will rise by as much as 12%, leading the likes of carriers UPS and Lufthansa to open new facilities aimed at catering for this growing revenue source, now worth an estimated $63bn. That increase is largely the result of economic development in Asia and Latin America.
"The transport by air of perishables such as fruit, vegetables, fish and even pharmaceuticals increases on a yearly basis in line with consumers’ expectations and demand," explains Gruber. "India is an important emerging market. IATA sees a shift in consumer markets that will drive that future growth, and shift the epicentre of air cargo. The emergence and expansion of Brazil, Russia, India, China and South Africa as major consumer markets will shift demand and lead to more balanced trade flows in the air cargo industry. We are already seeing this in China and to an extent in India. The growing middle classes in emerging economies are discerning high-end consumers who will continue to sustain air freight growth in the years to come."
Acknowledging that pharmaceutical products and the wider healthcare industry face a number of unique transportation challenges, Gruber says the most important issue for the industry and its logistics providers is to clarify mutual expectations between the stakeholders involved and to minimise risks for air freight within the cold chain.
"Temperature deviation and excursions of temperature throughout the journey require the establishment of a complete logistical process to maintain the shipment integrity," says Gruber. "Quality, reliability and performance are key. Therefore, dialogue, joint strategy and standardisation within the supply chain is needed."
But, she argues, the shipper is ultimately responsible. "They should ensure that the product and any necessary packaging is preconditioned to the required temperature, and will remain within a temperature range for a certain period of time, using the appropriate refrigeration method adapted to the shipping circumstances," Gruber explains.
Cargo control
For some time, however, this was not the way that pharmaceutical products were treated: they were simply batched together with other perishables. But, says Gruber, this posed its own challenges because the two cargoes were so different. These concerns ultimately led to recognition of the need for specific guidelines.
"It was identified that the potential gap and risk to time and temperature-sensitive healthcare products lay with having them sitting on the airport ground," explains Gruber.
Since then, guidelines have been introduced and subsequently adapted. Recent changes include:
- the United States Pharmacopeia (USP)’s ‘Supply Chain Integrity’ has a new general chapter (1083), Drug Product Distribution Supply Chain Integrity Pharmacopeia Forum, which describes the best practice for ensuring supply chain integrity with distribution practices
- the USP’s final Guidance and New Chapter (1079) on Supply Chain Integrity
- the World Health Organization’s new technical report ‘Model Guidance for the Storage and Transport of Time and Temperature-Sensitive Pharmaceutical Products’
- the European Commission’s revised guidelines on Good Distribution Practices.
One of the most recent significant changes to the way pharma products are transported has been the introduction of IATA’s Perishable Cargo Regulations (PCR). Because of the challenges IATA had identified in transporting pharmaceutical products, its Time and Temperature Task Force – a working group of air freight carriers, healthcare industry representatives and subject matter experts across the healthcare supply chain – worked to find solutions.
"The most significant were the implementation of a quality management system approach, and a time and temperature-sensitive handling label specific to healthcare freight," explains Gruber. "These developments needed implementation guidelines, with the solution being a specific chapter within the PCR. Known as Chapter 17 (of the tenth edition of IATA’s PCR), or ‘Air Transport Logistics for Time & Temperature-Sensitive Healthcare Products’, it addresses the requirements to transport time and temperature-sensitive healthcare products, and sets standards such as the use of the IATA Time and Temperature-Sensitive label."
Healthcare shipping label
On 1 July 2010, the shipping label, which is specific to the healthcare industry, was introduced. Initially, its use was ‘strongly recommended’, but the industry believed that unless guidelines were mandatory they would not be fully applied. As a result, on 1 July 2012, the IATA ‘Time and Temperature-Sensitive’ label will become mandatory, regardless of any agreement.
"Already, many federal healthcare regulators consider the label as a best practice, with the threat of shippers facing fines during audits for not following current best practice guidelines," says Gruber.
The label reflects the temperature range external to the package allowed during transportation and distribution to reduce risk of adverse exposure. The PCR Chapter 17 requirements set the standards that cold-chain stakeholders are required to meet.
"The Time & Temperature-Sensitive handling label came about as a result of standardising the nearly endless parade of labels applied by shippers throughout the industry," says Gruber. "In addition to the label, IATA is working on other projects to help tackle difficulties in pharmaceutical transportation. We will be focusing on describing the end-to-end business process flow between the stakeholders of the supply chain. This will allow the identification of minimum requirements that could be set as standard procedures that will need to be followed by the industry."
Room for growth
For pharmaceutical goods, the associated risks generate costs for industry stakeholders. Of the major challenges, controlling temperature throughout the supply chain and storage infrastructure are critical, but they are being addressed by improving facilities and equipment, and reinforcing quality management systems.
Speed to market is essential, particularly with the industry becoming increasingly dependent on air cargo. Because of this and the sensitive nature of the products being shipped, the procedures, practices and requirements of the healthcare industry must be understood and applied by all those involved in the supply chain.
While there has been a lot done and more planned, Gruber concludes: "There is further room for pharma and the logistics industry to work together in a better collaborative approach," which, she adds, will help meet future demands.
