If you don’t know much about compounding pharmacies, well, it’s okay — you’re not the only one.
Just over 3,500 of these operations exist in the country, not a large number, considering the total number of pharmacies (some 67,000) in the United States. It just so happens that one of the largest is based in Federal Way.
Key Compounding Pharmacy, with roughly 50 employees, is the largest compunding pharmacy in the Pacific Northwest. Like others of its kind, it doesn’t receive its medications prefabricated from ‘big pharma’ companies like Pfizer and Eli Lilly, then dispense them to customers.
Rather, Key makes its own medications in-house, receiving chemical components – called “inputs” – from a Los Angeles-based wholesaler and personalizing its products for each individual patient’s needs.
“Your typical medications you might get from pharmaceutical companies, it’s kind of ‘one dose fits all,’” explained Tom Masters, business operations manager at Key. “For a lot of people, their physicians like to kind of change their dosing a little bit to fit their specific, personal needs. But you can’t do that with a standard medication.
“That’s where we come in. You can go to a compounding pharmacy to adjust the dosing or maybe change how the medication is delivered – sometimes a tablet isn’t as effective as a patch or a gel or a cream or an injection. It’s basically customized medication, and it’s all done by prescription. We can even combine medications together in one, so if you’re taking several at the same time, sometimes, we can create something where you don’t have to take three or four different tablets. You’d be able to take it in one.”
Not a lot of people are familiar with it, so it may seem like a new concept, Masters said. Historically, however, it’s how pharmacies had traditionally operated.
“It’s the way that pharmacies used to operate before World War II,” explained Masters. “All the medications were kind of ‘made’ right there. But then with the rise of big pharma, they switched to mass manufacturing medications – basically, local pharmacies just switched to putting tablets from one bottle into another bottle, and that’s your prescription.”
Compounding pharmacies, however, are making a comeback, with market researcher IBISWorld reporting the industry’s annual revenue at roughly $5 billion. And while the segment’s growth has slowed somewhat, IBISWorld forecasts progress and improved conditions over the next five years, driven by demand for custom medications from an increasingly aging population.
Locally, Key is doing its part to expand the industry’s horizons.
“We’re sort of extending what we do into this whole realm of personalized medicine,” Masters said. “One of the things that has come along with the rise of genomics is the use of genetics in determining a patient’s dosing. What they’ve learned is just by your genetic makeup, you may or not be able to process certain medications effectively.”
The inverse, Masters, continued, may also be true; a person’s body may process a certain drug “too effectively.” Essentially, a person may metabolize a drug twice as fast as it was designed for, so that person may take a lower dose than the regularly prescribed dosage. On the other hand, someone who metabolizes medicine slowly may need twice the dosage to get the same effect as someone taking a standard dose.
“They’re beginning to realize that one size does not fit all when it comes to medication,” Masters quipped, “just from a genetic standpoint. Your body has about five or six metabolic pathways that all medication is processed through before it gets to the places where it needs to work. That’s a limited number of channels, and because of your genetic predispositions, a couple of those channels may not work as effectively.”
To that end, Key has partnered with Seattle-based Genelex Corporation, which offers YouScript Personalized Prescribing: a DNA test to determine if a medication’s dosage fits your specific metabolism. It begins with a simple cheek swab, which is then sent to Genelex’s laboratory for genetic sequencing and analysis of the patient’s unique drug-processing genetic characteristics. The company then delivers a comprehensive report of which medications the patient metabolizes normally, rapidly or slowly, along with any that the patient may not be able to metabolize at all.
The entire procedure, from taking the swab to receiving the results, takes about a week, Masters said, and the cost of DNA sequencing has decreased dramatically.
“That was our first question to Genelex,” Masters said. “Everybody’s sensitive to the cost of health care. But the cost of their test is a real eye-popper. It’s $1,200 that they bill the insurance company. However, their policy is, if the insurance company doesn’t cover it, they (Genelex) absorb the additional cost.
“But the insurance world is beginning to cover this test like Genelex is offering now,” Masters continued. “They’re realizing the benefit, because people don’t want to spend money on medications that won’t have a good outcome. I think, in not too many years, it might be standard for you to get your DNA sequenced for a wide variety of reasons, but certainly, if you’re taking prescriptions.”
The test has been around for a couple of years, but has only reached the public eye just recently, Masters said. Key Compounding aims to be at the forefront of the movement.
“We’re starting with our own employees,” he said. “We’re rolling out a pilot program for them to try it, and then we’re going to team up with our prescriber base to offer it to patients who would like to get their DNA sequenced and find out what medication metabolism issues they might have.”
Genelex first reached out to Key roughly a year ago about YouScript, and the firms reconnected in the early spring, with Key hashing out the details of a pilot and reaching out to area physicians since. At the end of September, Key kicked off a multi-part clinical webinar course for doctors to educate them on the program; according to Masters, roughly 50 or 60 physicians have registered for the series already.
“Patients hear about genetics and genomics in the news now, but it hasn’t really hit wide clinical practice yet,” Masters said. “Physicians aren’t as educated to it yet, so when the patient comes in saying, ‘Hey, I had my genome sequenced and here’s what they’re telling me,’ we want to make sure they’re prepared.”
“It’s pretty amazing stuff when you think about it in terms of personalized medicine,” Masters added. “It’s really the wave of the future. With the rise of genetic technology, the big pharma model is kind of under pressure.
“The average American has between 12 to 14 prescriptions. We’re the most prescribed country on Earth by far. People spend a lot of money a year on prescriptions, and those prescriptions may not be working for them as well as they could be. This (testing and compounding, too, are) something that could be great, not just from a business standpoint, but also for getting a healthier population on the whole.”