PharmacyChecker Blog

Helping Americans Get The Truth About Prescription Drug Savings
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I write this post about insulin with ambivalence and frustration, but also hope. The diabetes patient and activist community is rightfully seething, screaming at the top of their lungs about high insulin costs in America. One young man stands out in my mind. He recently died because he could not afford his insulin, and now his mother bravely speaks out about her son’s death—an example of why drug prices are a national crisis.

In a March article in Insulin Nation, the journalist/editor Audrey Farley and I discussed the issue of buying more affordable insulin online from pharmacies located in Canada and the U.K. She found that many of her readers were doing so and wanted to let them know how to go about it safely.

One carton of Lantus Solostar (5 pens of 3ml each), a long-acting insulin made by Sanofi Aventis in Germany, goes for about $430 at a CVS in Brooklyn, New York. At Rexall Drugs in Toronto, the price is $84.99. That’s 80% less. Until recently, a small number of Canadian pharmacies in our Verification Program sold it for about $180. The online Canadian price is higher because of the fees associated with special packaging and shipping – but it’s still 56% less than the U.S. price. For those prices, Americans living with diabetes could save a couple of thousand dollars a year; and those who can’t afford it here at all could stay alive.

Insulin is a temperature-sensitive medication and, because of that, requires significant precautions when shipping. To prevent it from degrading requires special packaging. Effective patient communication is also necessary. Because of our recent updates to our refrigerated medications policy, one that places stricter requirements on pharmacies in the PharmacyChecker Verification Program, most will likely choose not to sell insulin to Americans— at least not for a while. Here’s why…

Our former policy required the attention and care in line with, and even beyond many, U.S. state pharmacy standards. It banned (and continues to ban) pharmacies outside Canada, the U.K. and the U.S. from shipping insulin and other medications requiring refrigeration in the U.S. For those pharmacies in Canada, the U.K. and the U.S., the policy required cold packs in the shipment, a temperature indicator for the patient to review, and patient communications on how to read the indicator to see if the product is still good.

Our current policy takes it further. It requires pharmacies to ensure that their insulin shipments will not deviate from 2 to 8 degrees Celsius. Pharmacies must use optimal packaging for cold chain dispensing and temperature indicators that show the patient if the product froze during shipment or was exposed to heat in a manner that may compromise the product, in accordance with the specifications on the manufacturer’s label. The shipping method is verified by PharmacyChecker by requiring a demo shipment (without the medication) from the pharmacy. Our new standards also require a pharmacy shipping insulin to include the following patient notification on web pages where insulin is sold:

“This product requires special packaging to maintain its integrity during the shipping process. DO NOT USE THIS MEDICATION if the attached temperature indicator shows that the medication was exposed to temperatures below 2 degrees or above 8 degrees Celsius, and contact the pharmacy immediately.”

Dr. Shivam Patel, our director of pharmacy verification and information, is a doctor of pharmacy and licensed pharmacist in Massachusetts. He has reviewed the strongest U.S. state pharmacy refrigerated medication standards and laws and found none are as strict as the refrigerated medications policy imposed by PharmacyChecker.

For the past few years, very few pharmacies in our program have elected to ship insulin to the U.S., in part because of the strictness of our policy but also because they are afraid of the optics of a bad shipment of insulin. The FDA could intercept an order and potentially find that the insulin is compromised, then use this occurrence for publicity against all personal importation of medication.

Sadly, U.S. pharmacies don’t always take care in shipping and even properly storing insulin. However, when they make a mistake, they are probably not going to receive a letter from the FDA asking them to stop dispensing insulin, or any medications at all, to U.S. patients.

We don’t want to ban Canadian pharmacies that are lawfully permitted and able to dispense by mail more affordable insulin to patients in the U.S. who cannot afford it here. However, for the reasons stated above, we see the the necessity in making our pharmacy standards for international shipping of insulin higher than any here in the U.S. for domestic shipping of insulin.

Advocacy Call to Action

Our policy can be met. One problem for Canadian pharmacies and U.S. patients is that Federal Express and UPS may not overnight ship insulin from a pharmacy in Canada to a patient in the U.S. It is my belief that the couriers are warned by the FDA not to take such shipments due to technical prohibitions against personal imports.

I suggest that the diabetes community use its collective voice to ask that those couriers for clarification on their policies related to shipping insulin. Guaranteed overnight shipments would make it easier for licensed pharmacies in Canada to meet our policy and it would be just as safe, if not safer, than ordering from U.S. mail order pharmacies.

Furthermore, according to the website of Federal Express, “Importation of prescription drugs by an individual U.S. consumer for personal use is prohibited unless FDA approved.” Is Lantus Solostar an FDA approved drug? The answer is yes, but the label in Canada is different therefore the FDA deems it “misbranded” if sold in the U.S. However, a U.S. patient with the U.S. label in hand, and a prescription from their provider, should be able to overcome the designation of “misbranded” and legally import the drug. Food for thought.

Finally, I call on the community of diabetes patients and activists to weigh in on our policies and recommend modifications. If you and your providers can get behind a sufficiently strict standard for Canadian pharmacies to ship insulin to Americans who cannot afford it here, then please let us know.

Let’s talk!

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