The last mile: a metaphorical phrase that implies the end of a journey, the completion of a task, a sense of satisfaction and accomplishment. But it also carries with it the tenor of urgency, challenge and potential doom.

The term “last mile” is said to have originated in the telecommunications industry, representing the final leg of delivering connectivity from a communications provider to a customer. In recent years it has wormed its way into pharmaceutical supply chain vernacular.

The Parenteral Drug Association has published a very broad definition of last mile. According to PDA Technical Report No. 46, Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User, it describes it as a “multidimensional cross-industry term that defines a point in the supply chain where the product or service directly faces the customer, end user or patient.” This definition was obviously achieved by committee and, in order to conform with the document title, is inclusive of any and all stakeholders in the distribution process downstream from the drug product manufacturer.

To most however, last mile distribution of drug products refers to the final occurrence of physical transfer of the product to the patient. It can be a distance of a few inches or a few hundred miles, and can be administered by an on-site healthcare worker, a local caregiver, a retail pharmacist, or as is becoming more frequent in America, the U.S. Post Office and express shipping companies.

Mail order prescriptions have become the fastest-growing segment of the drug distribution process in the U.S., second only to chain store prescription sales. Pembroke Consulting reports that in 2010 nearly $62 billion, or 23% of all filled prescriptions in the U.S. were by mail order. Mail order pharmacies are the captive businesses of pharmacy benefit managers (PBMs) that include such giants as Medco, Caremark and Express Scripts, and which collectively control about 87% of the prescription U.S. mail order market. PBMs partner with insurance providers, pharmaceutical manufacturers, government agencies, physicians and patients. They typically operate on high volume but thin profit margins and are constantly looking for ways to reduce operational costs. Even some major chain stores have gotten into the mail order act as was evidenced by the CVS/Caremark merger and Walgreen’s recent acquisition of drugstore.com.

A significant portion of mail order distribution contains a $160 billion “niche” component usually referred to as Specialty Pharmacy, a wide variety of expensive therapies and value-added services that frequently includes temperature-sensitive medications that require refrigeration during transport. With the expected growth of expensive new and follow-on biological drugs, there is increased pressure to contain costs while ensuring effective medical and pharmacy management of an individual patient’s condition. Too often however, the lowest-hanging fruit targeted on the cost-cutting tree are packaging and shipping costs.

Last mile logistics present some unique challenges for maintaining drug quality. And while the cost benefits for mail order prescription services can be substantial, there is significant temperature risk to the drugs along this particular last mile path that differs from the traditional wholesaler to the retailer channel. Some mail order shippers provide a small layer of protection against heat transfer – or the appearance of such – by incorporating lightweight heat barrier materials, while others provide nothing more than a plain corrugated box or envelope. Few go to the extent of using insulated boxes and temperature stabilizers, like gel packs, due to the expense of the materials and increased weight/shipping costs. On the delivery side, express package services like UPS or FedEx don’t necessarily differentiate between a package containing temperature-sensitive drugs and a pair of mittens from the L. L. Bean catalog. And the U.S. Postal System supply chain is neither well understood nor well mapped. Packages under all of these distribution models are often exposed to extended periods of prevailing weather conditions as they make their way to our homes, bake in our mail boxes under the summer sun or freeze on our front doorstep for hours or days at a time, until we collect them and bring them into a controlled environment in our homes. If we are skeptical of a refrigerated product’s integrity due to suspect temperature exposure during delivery we are often told by a well-intentioned customer service representative that if the product is “cool to the touch,” it is safe. This is akin to saying if you scrape the mold off your cheese you can eat it without fear of any gastronomical distress.

Once a drug is received through the mail there is no guarantee that the drug products will be properly stored according to the label. We forget to return them to the refrigerator, or we have been conditioned to store them in a safe place: “the medicine cabinet,” located in the hottest, wettest room in the house, the bathroom, exposing the drugs repeatedly to elevated temperature and humidity, unwittingly reducing their efficacy and shelf life prematurely. And we are more likely to keep and use drugs past their expiration date anyway.

Ignorance, misconceptions, gaps and breakdowns during the last mile has been publically addressed by at least one major pharmaceutical company, which recently presented a case study indicating that 55% of all calls to its Medical Information Center in 2010 that were related to product stability and temperature exposure came 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 complete understanding of drug stability and execute handling procedures flawlessly thus making inquiries unnecessary, in reality it is indicative of the lack of knowledge and the disconnect in the current system. A doctor’s involvement in the supply chain process often begins and ends with writing the prescription, which is either administered on-site by a knowledgeable, registered healthcare professional other than the doctor, who is familiar with and has some control over the drug’s storage and handling requirements (such as infusion therapies or vaccines), or the prescription is filled by a pharmacist on behalf of the doctor and handed over – or mailed – to the patient. The latter places the responsibility of communicating any special handling and storage instructions on the shoulders of the pharmacist, where in 2009, 50% of all U.S. prescription transactions took place, according to IMS Health. Do retail and mail order pharmacies have an obligation to communicate any special handling or storage conditions to the consumer? Are they obligated to provide adequate protective packaging when administering temperature-sensitive prescriptions at the point-of-sale? Where do the pharmacists’ or PBMs’ responsibilities to the patient end? Perhaps this helps explain why 88% of all field inquiries in the aforementioned case study came from pharmacists and consumers.

Direct pharmacist-to-patient communication has long been one of the value-added hallmarks of the retail corner pharmacy where a local independent pharmacist typically fills 800 prescriptions a week. A chain drug store on average will fill twice that number. However, establishing a personal relationship is difficult when dealing with PBM prescriptions, where a large mail order house will fill 800,000 a week – or more than an independent pharmacy will fill in 19 years.Currently there is no top-down regulatory enforcement to force change to this paradigm. Therefore, it needs to be undertaken by the patient.

As consumers and patients, we must educate ourselves. We should at least know to question the quality and safety of drugs that are mailed to us that have been sitting in our mailboxes all day as readily as we question the quality and safety of the potato salad that has been sitting out all day at the 4th of July picnic.

Why are We So Trusting and Complacent About the Drugs We Take?

Stability of the drug product is well understood by their manufacturers, but this knowledge is not transmitted effectively, and sometimes purposely, downstream in the supply chain. And the further down the supply chain a drug progresses, the greater the likelihood an unwanted event will occur that can affect the quality of the drug product. By the time the drug reaches the last mile, the odds become overwhelmingly in favor of an adverse event occurring. As consumers, we should not accept this. We should not accept that “cool to the touch” is the same as refrigerated. We should not blindly trust the system. We should not wait around for an adverse event to occur that sickens people, endangers their lives or causes death. We should not apathetically wait for the media to bring this to our attention.

We should make this a patient responsibility. We should insist that the quality of the drugs we ingest are properly maintained when and where we can. Last mile distribution can be the first mile we impact.

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