Health Canada fails to act as drug shortages impact trans men

An ongoing drug shortage is causing a hassle for trans men and other users of injectable testosterone.

Mary Potter is a registered nurse with the Sherbourne Health Centre's [1] LGBT Primary Care Program. She says the most important thing for users to know is that they have other options for medication.

"The issue is when they don't come to see us or... they're told by the pharmacy that they just don't have it and people are waiting without the medication," she says.

Waiting, rather than finding an alternative drug, can result in a lapse of the medication's effects. "They should be coming in to see their physicians or nurse practitioners because they can be switched to a different compound."

She says that this is the second time a shortage of the drug has happened this year. "We actually had a recent problem with Delatestryl being back ordered; there was an issue with the raw material in the summer," Potter says.

Five pharmacies in Toronto were asked about the availability of Delatestryl. All the pharmacists contacted said the drug was on back-order.

But another injectable testosterone, called Depo-Testosterone (testosterone cypionate), is available. The concentration of the active ingredient is lower in Depo-Testosterone, so injections may be bigger and more uncomfortable, and the drug is made with a different oil.

A topical gel and patch are also available, although they are significantly more expensive. Adam Silvertown [2] is the pharmacy manager at Pace Pharmacy on Isabella Street. The transdermal patch, known as Androderm, can cost users between $150 to $160 a month, he says.

Silvertown says a month's supply of Delatestryl is cheaper, ranging "from high $60s to the mid-to-high $70s, depending on the pharmacy."

Potter says pharmacies and health providers should reach out and tell those who are using the drug about the shortage, so that users aren't surprised.

Theramed, the former manufacturer of Delatestryl, recently sold the product rights [3] to Valeant International, another drug distributor.

But Valeant Canada's Carine Remolien, a pharmalogical co-ordinator for Valeant Canada, says that Valeant's purchase of Delatestryl is not the reason for the shortage. She says the product is unavailable because of a "manufacturing delay."

"The product might be available January 15," she says, but she adds that the date for its return remains uncertain.

Lorraine Allen is manager of operations for Theramed Canada, the company that used to manufacture the drug. She refused to comment on the winter shortage or on Valeant's acquisition of the rights to the drug. However, she did say that Theramed's earlier shortage in the summer was, also, "due to manufacturing."

When asked to explain what sort of problems in manufacturing had caused the shortage at that time, Allen responded, "This is a privately held company. There's no more information you're going to get from us."

Jeff Morrison is director of government relations and public affairs for the Canadian Pharmacists Association. He says, "there's no requirement on the part of manufacturers or industries to disclose why a particular drug is in short supply."

Dr. Joel Lexchin, is a professor in the Atkinson School Health Policy & Management at York University. Lexchin isn't familiar with the particular shortage, but notes that shortages are a global problem.

"There are a number of things that can cause the shortages," he says. "One of them is the fact that the drug companies are accessing the active ingredients, in many cases from developing countries primarily India and China, and the production standards may not be as stringently enforced as they are in North America.

"You can also get loss of production for purely economic reasons, sales aren't high enough and the companies decide it's not in their interest to keep making the product."

Lexchin says there's not much that Canadians can expect will be done to stop such drug shortages soon. "In the Canadian perspective, probably very little will be done to try to prevent this."

However, he does have a few recommendations.

"At a minimum Health Canada could require that drug companies, if they plan on stopping producing particular products, have to give a notice that would be in the range, six months to a year, so everybody could prepare for that," he says.

"You could go further and Health Canada could say to companies, if you're going to have a license to produce the drug, that you have to give a guarantee that you will continue to produce that drug for a particular period of time -- otherwise we won't allow you to market it."

Morrison, of CPA, says a new reporting system for shortages is allowing pharmacists to anticipate problems in advance. Manufacturers haven't yet reported Delatestryl as being in short supply, he says. However, he says, the system for reporting drug shortages is about two weeks old and still working out some kinks.

Morrison wants to see the state using its purchasing power to pressure drug manufacturers to maintain a steady supply of their products. "Provincial governments... are big purchasers of drugs for their public drug plans. A lot of the contracts provinces have with manufacturers, there are clauses that mandate [drug companies to] maintain certain supply levels," he explains. "The problem is a lot of provinces just don't enforce those."

In a 2010 Canadian Pharmacists Association report, [4] 91.3 per cent of pharmacists said drug shortages "inconvenienced" their patients. 69.8 per cent said their patients' health outcomes were "adversely affected" by shortages.

"In a lot of cases, patients are the ones sort of having to run back and forth between their doctor's office and their pharmacy to get a new prescription and they're saying it's a huge inconvenience," Morrison says.

Benjamin Vandorpe was lucky. He filled his prescription before learning the medication was on back-order in Toronto. The Nova Scotia native says he first heard about the shortage from friends in that province. When he learned many Toronto pharmacies were also out of stock -- and could be for about another month -- he decided to call the suppliers to ask what was causing the hold-up. Instead, he found himself bounced from one automated voice to another [5].

Vandorpe thinks Valeant and Theramed should have notified users of the drug about the hiccup. "Even just a note on the website explaining the situation would have been great, especially since there is only one person who deals with inquiries about medications, and she's out of the office until January," he says, in an email.

"A lot of people depend on this medication for physiological, mental, and emotional well-being," Vandorpe adds. "There are so few doctors who are willing to prescribe it to trans-identified individuals that it's a serious inconvenience to have to seek out another medication."

Potter seems to agree. "It is quite disruptive," she says. She says because an alternate product is available, the shortages create unnecessary frustration for clients. "Maybe I'll just be recommending the cypionate instead of the Delatestryl as a result of these shortages."

"Trans people have to fight so hard just to get that medication in the first place," she says. "Putting people through these gaps or making them... [have to] struggle to get a medication is just kind of unreasonable."

Katie Toth [6] is a journalist based out of Toronto, Ontario. A shorter version of this article originally appeared in Xtra! Canada [7].

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