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Temperature Management of Pharmaceutical Distribution: Update 2008
As world populations continue to become more sophisticated and more
interconnected, the growing importance of the sustained quality
and easy availability of pharmaceutical products cannot be overestimated.

Mike Beard

GLOBAL SALES GROWTH in pharmaceutical products for 2008 is forecast to be in the 5 to 6 percent range, totaling $735 billion according to IMS Health, up from $643 billion in 2006. Today the North American pharmaceutical market represents 50 percent of that worldwide total, with Canada’s share at 3 percent. However, fully 31 percent of new growth is coming from less prosperous countries outside the traditionally leading markets of the U.S.and Japan,where year-over-year growth has fallen to 4 to 5 percent—all-time lows. Many factors drive these statistics,including maturing North American populations and the swift rise of economies outside North America.
Traditionally, the global pharmaceutical industry has been characterized by quick,profitable expansion and structural stability while demonstrating dramatic innovations through intense, expensive research.However, in 2008 pharmaceutical companies find themselves on a stage set for wrenching change. Dramatic developments in medicine; the rise of biotechnology; the long,arduous path to drug approval; rising costs of research and clinical trials—all contribute to this economic squeeze.
Online opportunities to sell drugs not only erode potential profits but seriously challenge the security of the supply chain. Knockoffs invade and confront any semblance of product integrity, a central foundation of patient confidence.
Countries around the world continue to struggle with managing the growth of pharmaceutical and other treatment costs as more and more innovative drugs and rising patient demand outstrip public budgets and private willingness to pay. This leads to a continuing— some would say relentless—drive to wring cost savings from both global and national supply chains. One result has been the consolidation of prescription and over-the-counter (OTC) distribution through third-party warehousing and logistics providers.The advantages of this model are that fewer trucks vie for time and space outside busy pharmacies and hospitals. In effect, the distributors become the customers of pharmaceutical manufacturers and collect vital marketing information for their suppliers.

TEMPERATURE MANAGEMENT One area of increasing regulatory scrutiny is the transportation of temperature-sensitive pharmaceuticals and OTC medications.
In North America the United States Pharmacopia’s USP1079, “Good Storage and Shipping Practices,” and Health Canada’s “Guidelines for Temperature Control of Drug Products During transportation and Storage” (Guide 0069, November 2005) each lay out regulatory expectations and good distribution practices for temperaturesensitive deliveries. The Canadian document is expected to be revised later this year.
The transportation and delivery management of temperature-sensitive products enters the world pharma stage as a necessary, complex and expensive set of technologies, suppliers and protocols. In general,what regulatory agencies require is monitoring, data and records—in other words, proof. That is, proof of temperature (POT) from point of origin to point of delivery is required for all pickup and delivery vehicles, line-haul trailers and temperature-managed facilities, as well as the transfer of products between each. Even greater risks are apparent when including air transportation in the mix. A manufacturer’s first step in complying with this mandate is to develop categories based upon stability data for all their products. Each category describes modes of transport, approved carriers, temperature limits and allowable excursions. At what temperature is the product stable and when does temperature begin to alter its efficacy over time? Precise lengths of time out of range, plus the severity of temperature excursions themselves, must be established and documented both for in-house production and storage and for out-offacility shipping and distribution.

SPECIAL NEEDS DEFINED Ambient temperature offerings keep pharmaceutical products at room temperature: between 15°C and 25°C (59º–77ºF). Cold-chain temperatures must remain between 2°C and 8°C (35º–46ºF),which is typically required for sensitive blood resources, vaccines, serums and biotechnology products.
Volatile swings in the weather, coupled with vast distances between population centers, defines the North American condition. These circumstances make temperature-managed transportation programs all the more necessary—and make their success all the more difficult. When designing strategies to eliminate environmental threats, pharmaceutical companies must come to grips with the risks of failure for patients, for product integrity and for their brands. So what do pharmaceutical and health-care manufacturers look for in a temperature-management ally? First they must find a collaborative partner who will:
• extend the rigorous care that is so important within their organizations out into the real world;
• build an open,cost-effective program that will protect their products on every level;
• share information and lessons learned;
• be available 24/7 in time of need; and, most important;
• provide the proof-of-temperature data as required.
Finally, partners must search for culturally aligned copartners they can trust, each of whom completely understands the differences,expectations and sometimes limitations of the other.

THE DISTRIBUTION PROCESS Typically distribution begins at the pharmaceutical manufacturer’s initial point of release, usually a temperature-managed warehouse.What’s notable overall is the sheer complexity of the supply chain, the number of facilities and vehicles required, the loading/packing/storage operations (typically hot spots of high risk) to be performed,and the scanning technologies needed to route and track each package. All personnel, from managers to facility workers to drivers,must be fully trained in the required procedures and technologies. An appropriate system for identifying and labeling temperature-sensitive packages must be universally recognized and understood.Each new technology and standard operating procedure (SOP) must be thoroughly tested and qualified.
Preparation within facilities should follow good manufacturing practice (GMP) for setting up and continuously monitoring temperature-managed rooms. However, setting up temperature-management programs, and the reporting and tracking technologies that enable them within transport vehicles, is an emerging science. Proactive strategies that convert incoming temperature and logistics information into preventive actions should be put in place. Contingency procedures and systems must be introduced to mitigate the negative effects of power and mechanical failures, catastrophic events and weatherrelated delays of service, plus any number of other possibilities.

TEMPERATURE MAPPING For the temperature to remain within precise limits, sensors must be set in both vehicles and warehouse storage rooms. Temperature mapping to show variations throughout each room and trailer should be performed during annual extreme climate fluctuations and when the spaces are full and empty of content.These results will point to the best placement for calibrated monitoring devices and to the manner in which shipments should be stacked to maximize airflow. Temperature mapping and all other temperature management procedures, systems and technologies must be qualified by an experienced quality-assurance and control department,whether in-house or outsourced,that is thoroughly trained in validation activities.

LOADING PROCEDURES Temperature-sensitive products must be properly scanned into a tracking system at each step,at the loading and unloading of the trailer and upon entering and exiting the temperature-controlled room or facility. Warehouse personnel must be trained to stack product packages and skids safely according to established load patterns, leaving room for the easy flow of air around, above and below packing areas that is required for refrigeration techniques. Prior to departure, drivers must inspect their vehicles, refrigeration devices and the products being shipped in accordance with established protocols.

ON THE ROAD Once the shipments are on the road, temperatures must be relayed on a consistent basis to a central monitoring station. Excursion alerts should be conspicuously posted on the screen.Complete alert histories,of both single vehicles and the entire fleet, should be easily accessible. In case of excursions or other incidents, the ability to replay what transpired is a necessary ingredient both in understanding what happened and to prevent further occurrences.

What’s important in the future is to promote a culture of industry collaboration and to champion the value of information-sharing across all stakeholders. Regulatory bodies in the U.S. and Canada may differ somewhat in their handling of new requirements,but in both countries and around the world the safety and quality protection of pharmaceuticals and other health-care products in transit can no longer be left in doubt.

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