"We have patients with chronic diseases like rheumatoid arthritis, multiple sclerosis, or perhaps an enzyme deficiency. There are fewer patients requiring these drugs than say, drugs for diabetes. These are very expensive drugs, and there's a limited quantity of them." One example, he says, "is for an antibody-related cancer drug that can run upwards of $4,000 a month." Some of these specialty medications are combination products, "hybrids" of a drug and a device, such as a pen or a syringe that serves as the carrier for the drug.
The 33,000-sq-ft Lake Mary facility receives packaged drugs either directly from the pharmaceutical manufacturer or through a distributor such as McKesson or AmeriSource Bergen. Manufacturers are responsible for maintaining the drugs within the 2ºC to 8ºC temperature range from the time they're made to when they're received by WMSP. At the Lake Mary facility, WMSP stores drugs in coolers, refrigerators, or freezers. "All of the refrigeration units are monitored by devices 24/7/365," says Soucey.
Soucey delivered a presentation entitled "Cold chain at the 'local' pharmacy, the real 'last mile of distribution,'" during the 5th Annual Cold Chain Distribution for Pharmaceuticals event last September in Philadelphia.
At its facility, WMSP relies on wireless remote monitoring systems from Isensix, Inc. "They are used mostly in hospitals and blood banks," says Soucey. "We are probably one of the few standalone pharmacies using their monitoring devices. One of the primary reasons we picked them was that their software is Food and Drug Administration-compliant as far as security levels and things like that. They have a wireless setup where you monitor temperatures in each of these units. It feeds that data back into a sensor that feeds a server. The server takes the data, then forwards it to the Isensix home server in San Diego.
"We are usually open from seven in the morning until eleven at night, so if something were to happen [with a temperature fluctuation] at three in the morning, an alarm would sound. Our server would pick that up and relay that alarm information to the San Diego server. Depending on what the alarm type is, somebody from our company is either paged or called [to assess or repair the problem]. If we need extra help, we will get in touch with Isensix. We monitor one walk-in freezer, a large, walk-in cooler, and nine floor units, so 11 in all."
Products arrive at WMSP prepackaged from manufacturers, so the specialty pharmacy operators in Lake Mary focus on "caretaker" tasks, meanwhile making sure packaged products are maintained and delivered within the 2ºC to 8ºC temperature range.
"For 'outlier' areas such as Hawaii or Alaska, we use packaging that is prequalified to maintain products within that temperature range for about 48 hours," says Soucey. Purchased from Tegrant Corp., formerly SCA Packaging North America, the packaging includes a corrugated shipper with a polyurethane inner foam liner/cooler, as well as refrigerated and frozen gel packs.
WMSP developed a package with Alpine Packaging Group, Inc. that is used for the majority of its monthly shipments. It consists of (two sizes of) a corrugated overpack, an inner expanded polystyrene cooler, and various seasonally adjusted numbers of gel packs to maintain medications at the compendial range for better than 36 hours.
Soucey says, "In general, we pack one order per shipper or one product per shipper. It's not like mail order where you might get five or six of your drugs at one time. An exception would be if you are being treated for Hepatitis-C. Then you might be taking an injectable and a capsule that are shipped together to the patient, but usually we send one product per package."
WMSP employs 118 people at Lake Mary. Its packaging process, Soucey explains, is largely manual, with the exception of what he refers to as standard conveyors. "No other machinery is necessary because we're taking finished pharmaceutical products packaged by the manufacturer and putting them in refrigerated shippers to deliver them to the clinic, or to the patient's home," he says.
"The legality of it is that we must preserve drugs in the state they came in from the manufacturer until they reach the patient. Essentially, we own that drug until the patient signs for it."
Soucey says that WMSP is investigating the use of a pharmacy-provided overpack that would allow consumers "to take a product they just purchased from the retail pharmacy and pop it into the bag, which would come from the Wal-Mart pharmacist and would keep the prescription at the appropriate temperature for three or four hours." He says a couple of versions of the device-a reclosable and perhaps reusable pouch-are being tested.
For WMSP customers, Soucey points out that product must be kept within the 2ºC- to 8ºC-range for a considerably longer time span. "There's a dirty little secret about common carriers in that they may pool their shipments for two to three days before they actually send it out to an outlying area such as Alaska-as a way of improving their efficiencies. That means we really need shippers that last 72 to 96 hours," he says.
To address that need, Soucey says WMSP is exploring a shipper that would maintain appropriate temperatures for 96 hours. Cost, understandably, could be a drawback. "In any specialty pharmacy operation, be it ours or a 'mom-and-pop' business, we all eat the cost of shipping," says Soucey. The consumer relies on insurance and/or takes care of their co-payment. A script sent to Alaska or Hawaii might cost us up to $150. Our average shipping cost is about $22,000 a day." Nearly all of WMSP's 8,000 to 10,000 monthly shipments are delivered overnight by common carrier. Only a handful of local customers pick up prescriptions at the Lake Mary site. [HCP]
--By Jim Butschli, Editor