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Managing the transportation and distribution of temperature-sensitive drug products has always been a top-down process, beginning with manufacturers evaluating how their supply chains work. Focus has been on qualifying appropriate packaging, transportation lanes and modes of transport.
This approach then cascaded down to the wholesaler level and filtered unevenly into supply chain segments such as among air carriers, integrators, freight forwarders and packaging companies. Too frequently, however, the farther down the drug delivery supply chain one travels, the greater the risk and the more out-of-control the process becomes.
The most common gaps in the supply chain for temperature-sensitive drugs occur as the result of three conditions: lack of understanding of regulatory requirements; poor communication to downstream supply chain partners; and little to no enforcement or accountability at or near the end of the supply chain.
Helping to inadvertently muddy the waters of complexity within the temperature-controlled supply chain is the raft of new and sometimes contradictory regulations—often country-specific—and an abundance of guidance and best practice to meet those expected requirements. For all their best intentions, what’s lacking is harmonization. To date there are 34 documents worldwide generated by dozens of agencies and associations covering Good Distribution Practices (GDPs) for medicinal products with most giving special consideration for temperature-sensitive drugs. Herein lies one of the biggest gaps in the supply chain—knowing which rules apply when and where and what guidance does one use to comply?
But there is hope on the horizon. The Swiss-based Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S) met in May 2011 to discuss extending PIC/S mandate to include GDPs in addition to their current charter of GMPs as regulators encounter a growing number of serious problems during the inspection of the supply chain. The measure, which is largely supported by its members representing 39 participating governmental authorities, is looking into whether the newly drafted GDP Guide authored by the European Medicines Agency with experts from EU Member States (and expected to gain approval in 2012) could serve as the basis for the PIC/S GDP Guide.
Communication to downstream supply chain partners is the ultimate responsibility of the drug manufacturer or drug license applicant. As more suppliers and service partners engage in transporting specialty pharma products, there is a growing inequality of reliable execution. This is why regulatory authorities worldwide have honed their sights on the robustness of quality management systems, including increasingly detailed quality agreements among service providers. As an example, the United States Pharmacopeia, the often emulated and frequently referenced public standards organization, has included the following statements in its latest draft of General Information Chapter <1079> Good Storage and Distribution Practices which is expected to become effective in the fourth quarter of 2012: “Good Storage and Distribution practices require that entities in the storage and/or distribution of drug products maintain a Quality Management System (QMS)…” and “…written agreements should be in place between applicable organizations to ensure clarity, transparency and delineate responsibilities of each organization in the supply chain.” To meet these goals, many supply-chain service partners have instituted specially trained or exclusive teams to handle pharma products/clients.
Last mile breakdowns
Ignorance, misconceptions, lack of communication and the breakdowns in the supply chain that result in temperature abuse are subject to increased occurrences during the last mile. Abbott Laboratories recently presented a case study indicating that 55% of all calls to its Medical Information Center were related to product stability and temperature exposure, and came directly from consumers. Another 33% were from pharmacists. Only 2% came collectively from medical doctors or nurses. While one might conclude from these data that doctors and nurses have a thorough understanding of drug stability and execute handling procedures flawlessly thus making inquiries unnecessary, in reality it is indicative of the disconnect in the current system.
I have long advocated the need for a simultaneous bottom-up push for improved handling of temperature-sensitive drugs and for regulatory compliance. There is a gap of not only distance but of expertise and interaction between those at the top of the supply chain and those at the bottom—along with considerable misunderstanding and ignorance as to the importance of handing temperature-sensitive drugs. Without enforcement and accountability at the last mile all the upstream efforts to get drugs safely to this point are for naught.
ABOUT THE AUTHOR
Kevin O’Donnell is Senior Partner at Exelsius Cold Chain Management (www.exelsius.us; tel: 847 363 8847), an international provider of research, training and gap analysis consultancy services to supply chain partners in the life sciences sector, with offices in the US and the UK. Previously, he was Director and Chief Technical Advisor to Industry at Tegrant/ThermoSafe Brands, and is chair of the International Air Transportation Assn. Time & Temperature Task Force. He is also known throughout the industry for his blog on management of temperature-sensitive life sciences products, Clutchcargo.us (formerly CoolerHeadsblog.com.)