Medical Device Link.

Originally Published PMPN March 2003

NEWS

Packaging, stability, shipping, and storage are coming into play as elements in the concerns about Canadian drugs being sold into the United States.

On January 3, 2003, GlaxoSmith-Kline Inc. (GSK; Research Triangle Park, NC) sent a letter to Canadian pharmacies suspected of selling the company’s Canadian pharmaceutical products into the United States. The letter said it would refuse to supply products to any wholesaler or distributor that did business with such pharmacies. Some U.S. consumers try to obtain their pharmaceuticals from Canada for price reasons. With the letter, GSK became the first pharmaceutical company to formally take measures to prevent the practice.

The letter attracted national media coverage and prompted discussions of trade pacts, drug pricing, intellectual property and patent law, and contract law. It even elicited concern from FDA Commissioner Mark B. McClellan, MD, PhD, at the UBS Warburg Global Healthcare Services Conference on February 4 in New York City. “We do not have any control over the safety and effectiveness of those drugs,” he said. “Neither does the Canadian government. They are prohibited by their laws from regulating anything that does not go to a Canadian citizen. So, these are not safe and effective products. This is a significant public health concern.” 

At the heart of GSK’s letter is concern about storage and shipping. “We are concerned that our medications may be being transported directly to patients under improper storage conditions,” stated the letter, written by Steven Popp, GSK’s director of customer operations and distribution strategy. “Products shipped directly to patients can be exposed to radiation and/or temperature and humidity extremes during transit that may affect the stability and effectiveness of the medications and put patients at risk.”

However, Paul Clark, president and chief executive officer of Hometown Meds (Carman, MB, Canada), one of the pharmacies targeted, called those statements “complete and utter nonsense. One short trip in the air between Canada and the United States will in no way, shape, or form compromise the stability of the product,” he said. “It seems to me a company like GSK manufactures its finished product within a certain safety margin that allows them to send it all over the world in a safe and effective manner.” He said that his pharmacy will only send its U.S. shipments in the original manufacturer’s packaging, avoiding stability concerns that can arise from repackaging, and strictly follows any shipping and refrigeration instructions listed by the manufacturer on the label. 

“If they have a valid concern, then show us the studies that show the product is being compromised,” Clark said. “If there are safety concerns that Glaxo has identified, why not bring them to the industry in a proactive fashion? I can give hard data on my end. We are saving lives.”
But C. Jeanne Taborsky, a former FDA reviewer who is now proprietor and senior consultant for SciRegs (Columbia, MD), said GSK did the right thing.

“They are taking a reputable stand,” she said. “We can only test drug products for foreseeable conditions. There is a risk any time they are exposed to conditions for which they have not been tested.”

Unplanned shipments from Canada to the United States can also be a problem because the packages may be irradiated at the border as part of anti-terrorism efforts, Taborsky said. Radiation can cause some pharmaceuticals to lose their potency. “You can’t just put a drug product through gamma,” she said. “A drug company would have to validate that practice.”

Another concern, she said, is that if Canadian pharmacies do repackage before shipping to the United States, some pharmacy vials used in Canada, mainly ones made of polystyrene, do not meet United States Pharmacopeia (USP; Rockville, MD) standards, meaning they are not protective enough for use in the United States. 

Claudia Okeke, PhD, senior scientist for USP, noted that “most drugs, if properly packed, will have no problem” being shipped anywhere. But “some drugs are temperature- and humidity-sensitive products,” meaning highly susceptible to temperature and humidity extremes, and many will prompt concerns if poorly repackaged. 

USP has been working on a proposal for a test to determine whether a drug should be classified as temperature and humidity sensitive, as well as a standard for storage and shipping, but neither is official yet, she said.

What’s important, Okeke said, is that “if you properly inform the pharmacist of the nature of the product, hopefully the pharmacist will realize that and handle it properly, as well as give the proper advice to the patient about how to handle it.” 

Copyright ©2003 Pharmaceutical & Medical Packaging News