The International Air Transport Association (IATA), the 230-airline member global organization, held its fifth annual World Cargo Symposium March 8-11 in Istanbul, Turkey with an estimated 1,100 people in attendance. During the opening plenary, Desmond Veritannes, IATA’s Global Head of Cargo, listed the industry’s leading improvements, and cited the implementation of the Time & Temperature Label for Healthcare Products. That label, the result of many hours of deliberation among supply chain stakeholders, was permanently implemented in 10th Edition of the IATA Perishable Cargo Regulations in 2010 as a recommendation by the airline industry. Now, they plan to make the label obligatory beginning in July, 2012.

Gradual Label Adoption

Adoption of the IATA Time & Temperature Label for Healthcare Products has been slower than expected since it was first introduced in 2009 and it remains a bit of an enigma within the industry. Its primary use has been seen in the clinical trials or investigational drugs market where adherence to tight temperature ranges are often more critical due to the lack of stability data on the products. Some major pharma and biologics manufacturers are beginning to phase in the use of the label for certain lanes, routes and international destinations where the risks to prolonged exposures of temperature extremes are greater than most. But widespread adoption of the label has not occurred partly due to a lack of understanding and partly due to lack of any regulatory enforcement. But all that is about to change.

Regulators Take Notice

Ian Holloway, manager, Defective Medicines Reporting Center at the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, stated at the IQPC Cool Chain Europe Conference in Rotterdam, Netherlands in January, “IATA has done great work in improving control of the supply chain process and the MHRA recognizes and fully supports the use of the Time & Temperature Label for Healthcare Products as a means of good distribution practices.” Additionally, Dr. Umit Kartoglu, Technical Officer at the World Health Organization (WHO), Department of Immunization, Vaccines and Biologicals, Quality, Safety, and Standards, also commented at the same conference that the IATA Time & Temperature Label for Healthcare Products is specifically called out for use in their agency’s newly adopted Model guidance for the storage and transport of time and temperature�sensitive pharmaceutical products. The document serves as a protocol between the WHO, distributors of approximately 43% of the world’s vaccines and its affiliated agencies like UNICEF, making use of the label a contractual requirement.

Health Canada’s recently revised GUI-0069, Guidelines for Temperature Control of Drug Products during Storage and Transportation, becomes effective April 28, 2011. It also makes reference in Appendix B, to Chapter 17 of the IATA PCR and the IATA Time & Temperature Label for Healthcare Products.

And finally, the United States Pharmacopeia, the standards-setting organization often tapped by the FDA as a source for best practices, is considering referencing the IATA label in its upcoming revision to General Chapter (1079) Good Storage and Distribution Practices.

Best Kept Secrets

Although the use of the label is clearly defined in Section 17.10 of the IATA Perishable Cargo Regulations Chapter 17: Air Transport Logistics for Time and Temperature-Sensitive Healthcare Products, the chapter, well-known by name, appears to have been read by few. The complaint from the healthcare industry – as repeatedly voiced during the Time & Temperature Track at the World Cargo Symposium and at the subsequent open session of the IATA Time & Temperature Task Force Meeting – was that IATA has done little to notify and educate the users of the document and has made Chapter 17 difficult for them to obtain. Healthcare products shippers have no use for the rest of the Perishable Cargo Regulations – a manual that contains 16 chapters on perishable flora and fauna – and the industry continues to lobby IATA for a separate stand-alone document. Other complaints from potential users of the chapter include IATA’s reluctance to make the chapter available in an on-line electronic and downloadable version, licensing reproductions of the document for distribution, and imposing a fee for the purchase of a document that is necessary to comply with IATA’s own regulations. The Secretariat of the Live Animals and Perishables Board / Time & Temperature Task Force at IATA has agreed to take these concerns to the IATA Publications Department in hopes of an amicable and equitable resolution.

Changes Coming

During the World Cargo Symposium in Istanbul, the Cargo Services Committee at IATA met and voted to adopt mandatory use of the Time & Temperature Label for Healthcare Products. It was resolved to be included in the 12th Edition of the Perishable Cargo Regulations effective July 1, 2012. While in the long run this is probably a good thing, it leaves little time for the industry to get up to speed and adopt the label and to use it properly. Currently, air carriers have to use a double standard for healthcare products: those with a label and those without. This forces an undue burden on those handling the freight and raises the risk of confusion along the supply chain for those responsible for these products, i.e. freight forwarders and ground handlers.

It is clearly in the industry’s best interest – shippers and carriers alike – to adopt the label and educate their supply chain partners on the proper use of the IATA Time & Temperature Label for Healthcare Products. The label is unique to the healthcare industry and cannot, for example, be used on perishable products. It is not a cure-all however, and IATA is careful and adamant when stating that use of the label in and of itself is not a guarantee. “Time and temperature sensitive healthcare product shipments should be labeled with the standard IATA ‘Time and Temperature Sensitive’ label only when a specific agreement (i.e. SLA, QMS, SOP, etc) between the stakeholders is in place (PCR 17.10.5.) and the label “must only be applied where specific arrangements have been agreed to by the stakeholders (forwarder, handling company, individual airline carrier or other partners within the logistics cold chain) for the transport of healthcare products.” (PCR 17.10.6.1).

Consequences for Not Using the Label?

“Unless otherwise specified in a contractual agreement, it is the responsibility of the shipper to apply the Time and Temperature Sensitive label for Healthcare Products to the outermost visible means of containment (e.g. package, overpack, ULD, etc) to be shipped.” (PCR 17. 10.6.1) Shippers of time and temperature sensitive healthcare products need to get on board with IATA and adopt usage of the label – ideally, before the mandatory deadline. If they do not, two likely consequences will result:

1. Shippers who opt out of using the label and any additional costs for levels of service required are likely to have their products shipped as “general cargo.” In the airline world, general cargo receives the least amount of priority in terms of handling, flight and storage. This translates to high risk of exposure to extremes and delay – the bane of any time and temperature sensitive drug product shipment.

2. Global regulators are increasingly scrutinizing supply chains and distribution practices and are aware of the airlines efforts to improve their processes in an effort to minimize risk in the supply chain for drug products. As long as regulatory authorities recognize the use of the Time & Temperature Label for Healthcare Products as part of cGDP, shippers will have a hard time defending why they haven’t adopted it.

You can obtain a copy of the Perishable Cargo Regulations only by contacting IATA directly. The printed version (English) is $175, the e-version is $225, and the combo costs $290. Here’s a link to their publications section: http://www.iata.org/ps/ publications/Pages/perishable-cargo.aspx

Kevin O’Donnell is director and chief technical advisor to industry at Tegrant Corp., ThermoSafe Brands. He can be reached at kevin.o’[email protected]. His blog, Where Cooler Heads Prevail, can be found at http://www.coolerheadsblog.com/blog/