Cecily O'Connor
RedwoodAge.com
For about two years, Wendy Merrill has been taking a custom compound of drugs to combat a triple-whammy of stress, exhaustion and menopause.
She's among a growing class of baby boomers, notably women, who profess faith in "compounding," the process of producing drugs designed specifically for each patient's needs and genetic makeup.
Drawing on pharmacology's founding principles, the thinking behind compounding is that a one-size-fits-all medication isn't always the best cure for what ails you.
While compounded medications might be more expensive than a commercial drug, a far greater range of treatment options often outweighs the expense.
Merrill, for example, says her bio-identical hormone replacement therapy (BHRT) minimizes side effects with a unique blend of estrogen and progesterone that has been made to mimic the same structure and function as her own hormones.
"It's like installing new shocks [in a car]," said the 50-year-old author from Sausalito, Calif. "I am still traveling a bumpy road sometimes, but it's not like I’m hitting a lot of potholes."
In addition to hormone therapies, compounding is used in a variety of other health concerns that often accompany aging, including dermatological treatments, dental medications and pain management. Pediatric and veterinary prescriptions are common, too.
"As you get older, you’re going to have some specialized needs that start to arise, and compounding has been able to provide some options to people experiencing those changes," said Dagmar Climo, spokeswoman for the Professional Compounding Centers of America, which represents 3,400 licensed compounding pharmacies.
Some women might need a lower amount of estrogen than what is mixed into a mass-produced prescription drug. Other patients might be allergic to a specific ingredient in a commercial medication and require a tailored prescription.
Sometimes patients require their medication to be mixed in a form other than a pill. For example, compounding pharmacists can dispense certain prescriptions as topical creams for hospice care patients who are no longer able to swallow. Other forms include lollipops and suppositories.
Compounding is, in a sense, "going back to the future for pharmacy," said Peter Koshland, a pharmacist at Elephant Pharm in San Rafael, Calif., which has stepped up its hormone marketing efforts since opening a centralized compounding facility in July.
Compounding growth estimates are hard to come by, but one industry group said it is confident that consumer adoption will increase steadily over time. At least 1 percent of all prescriptions were compounded in 2005, according to Joshua Wenderoff, a spokesman for the International Academy of Compounding Pharmacists, which was founded in 1991 to promote pharmaceutical compounding. He said BHRT likely accounted for the bulk of prescriptions, but added that cancer treatments and hospice care also are areas in which compounding is prevalent.
"As doctors and patients become more aware that this service exists, it's going to be adopted more," Wenderoff predicted.
Push For Change
Elephant Pharm's marketing push follows a time in which women have been more
vigilant about hormone replacement therapies after concerns in 2002 about
Premarin, a synthetic estrogen offered from Wyeth Pharmaceuticals that's made
from pregnant horse urine. That was a wake-up call to doctors and pharmacists
about their assumptions in treating menopausal women.
Baby boomers are "looking for individualized care...we're champions of women's rights," added Stacy Bischoff, a women’s health care nurse-practitioner in San Rafael. "We're forward thinking and like change that benefits the human body, mind and spirit."
Bischoff said she likes to do saliva or blood tests to look at women’s hormones and give them choices about their treatments.
"I also ask, 'What’s your lifestyle like? Do you like creams or lotions? Or a dropper bottle?'" she said. "The idea is to balance the hormones to do what they naturally do as best as we can."
Since starting her treatment with Bischoff, Merrill has not only changed her dosage of progesterone, but also the form in which she takes her meds.
Pharma Responds
At the same time, pharmaceutical manufacturers are placing more emphasis on
understanding genetics, and how patients respond to various treatments in
positive or negative ways, said Alan Goldhammer, deputy vice president for
scientific and regulatory affairs at Pharmaceutical
Research and Manufacturers of America, a trade group. One area of
particular focus is on liver toxicity and how it occurs in patients with certain
genetic predispositions, he said.
Many patients benefit from mass-produced prescription drugs that have been "extensively studied through clinical trials to understand the safety and efficacy of products," Goldhammer said. He claims compounded prescriptions were "never intended to replace pharmaceuticals that were proven safe and effective by the Food and Drug Administration..."
Yet expected increases in compounding has resulted in greater efforts to monitor the practice. Compounded prescriptions are regulated by state boards of pharmacy, but unlike manufactured drug products, are not under the jurisdiction of the FDA.
To promote quality assurance, IACP and seven other industry organizations started an accreditation program in 2004. So far, a "few dozen" pharmacies have earned the accreditation, while about 100 more are in the pipeline, Wenderoff said. "We hope this will provide uniformity of standards and the ability to verify quality of services by pharmacies," he said.
Costs and Considerations
Compound prices vary depending on the drug, quantity and amount of active
ingredient, as well as the labor and expertise involved in production, according
to Koshland. Most compounded prescriptions fall between $30 to $50, he said, but
some can cost as much as $300.
He noted some of the equipment can be expensive if you want to make a high-quality product. For example, a machine called an ointment mill dramatically raises the quality of topical creams and ointments by pulverizing the active ingredients to micron size.
As part of the cost equation, Koshland said about one-third of insurance plans cover compounds. However, the actual amount of coverage can vary, so it's smart for patients to do some homework about the expense.
While Merrill said she's been frustrated by some billing issues, she still recommends that others give compounding a try. "I have three younger sisters," she said. "As each one hits these milestone ages, I encourage them to investigate the possibility because it’s helped me."
