The International Air Transport Association (IATA), the 240-member inter-airline organisation promoting safe, secure and economical air services for the benefit of the world's consumers, has taken a significant step towards improving the handling of temperature-sensitive pharmaceutical products. The organisation, which represents more than 140 nations, is adding a new chapter to its 7th edition of The Perishable Cargo Manual that specifically addresses air transport logistics for temperature-sensitive healthcare products.
Both the current 6th edition of the manual and its predecessors offer detailed procedures for handling perishables of the flora and fauna variety, but guidelines for handling medicinal products have thus far been vague and incomplete, with a heavy emphasis on vaccine transport.
Over the past decade, the growth of healthcare manufacturing has largely gone from intra-plant to international. The pharmaceutical industry is experiencing unparalleled changes and challenges - globalisation, treatment and pricing economics, government controls and ever-advancing technology1. It is not uncommon for a drug to go through a complex creation cycle, from API to finished product, in multiple steps in multiple countries. As a result, the requirements for packaging, storage, transport and distribution have, like the drugs and treatments themselves, become more sophisticated and the ability to maintain precise temperature control more critical.
International transport of healthcare products now includes API bulk reagents and intermediates in addition to finished products. The packaging for transporting them has diversified, too. The sophisticated designs are often highly engineered and expensive - capable of protecting sensitive and valuable products from the rigours of transportation and environmental extremes. Packages can range in size from small boxes to pallet-sized bulk insulated containers. There are passive packaging systems and active or mechanical units. These are used to transport everything from prescription drugs such as pills and capsules to injectibles, diagnostic reagents, medical devices, blood products, organs and tissues.
Market growth combined with new technologies such as heat labile biologicals have also proliferated. Worldwide biologics products have been growing at double-digit rates for several years and are projected to continue this kind of growth for the foreseeable future as new biotech products enter the marketplace2.
Along with the increase and availability of new drugs, devices and treatments, there has been a significant increase in global regulatory oversight. Since the pharmaceutical industry is one of the most heavily regulated industries in the world, every step of the lifecycle process, including manufacturing, storage, distribution, application and disposal, must be well defined and follow strict government agency guidelines.
New pharmacopeial standards for medicinal products are introduced on a regular basis and invariably broadened to include proper handling, storage and distribution as an extension of their manufacture. There is increased monitoring, management and control of environmental conditions across the entire supply chain for temperature-sensitive pharmaceutical products3. There is also expectation from various global regulators that the supply chain be maintained, from the manufacturer to the end-user4.
The airline industry has at last recognised the need for new guidance and handling procedures and, through the Live Animals and Perishables Board (LAPB), has worked with members of the pharmaceutical industry and their shared service providers in establishing practical guidelines for shippers handling healthcare products, to create an industry-wide standard of excellence.
The 7th edition of The Perishable Cargo Manual will be published in June 2007, and for the first time will be binding to its members. This is a significant stroke of good fortune for the pharmaceutical industry. Improvements to the process should be immediate and positive, since this portion of the distribution chain has long been identified by the pharmaceutical industry as a potential problem - ripe for mishandling, with significant risk from temperature extremes and improper storage.
The LAPB has assured the pharmaceutical industry that the 7th edition will provide the foundation for improved ground handling procedures and that subsequent annual editions will further improve the process.
1. Koester, L and Nash, Kim, 'Building Supply Chain Capabilities in the Pharmaceutical Industry',UPS Supply Chain Solutions white paper, 2005
2. Pharmaceutical Commerce, April 2006, p6
3. Bishara, R, 'Cold Chain Management - An Essential component of the Global Pharmaceutical Supply Chain', American Pharmaceutical Review, April 2006, p106
4. Bishara, R and O'Donnell, K,A Systematic Approach to the Development of Temperature Profiles for Medicinal Products in Distribution
Kevin O'Donnell is director and chief technical advisor to the thermosafe brands division at SCA Packaging NA. He retired in 2005 from Abbott Laboratories as principal packaging engineer, responsible for the design, development, qualification and implementation of all temperature controlled distribution packaging for its global pharmaceutical division. His 26-year career at Abbott included more than 20 years' cold chain experience in the diagnostics and international global logistics and supply chain divisions.
Well respected in the US and Europe as a leading advocate for implementing good cold chain distribution practices, he is active in advising the pharmaceutical industry and is also heavily involved in draft guidance. In addition to consulting on cold chain management and distribution practices, he is a frequent speaker and presenter at industry conferences.
He can be contacted at [email protected]