Drug manufacturers produce medicines that meet the needs of most people. But what if you require a certain drug and you can't tolerate the preservatives and dyes that are added? You need a compounding pharmacist who can tweak the medication to your specifications.
The U.S. Food and Drug Administration states that pharmacy compounding is a practice in which a licensed pharmacist combines, mixes or alters ingredients of a drug in response to a licensed practitioner's prescription to create a medication tailored to the medical needs of an individual.
The FDA acknowledges that pharmacists engaging in traditional pharmacy compounding provide a valuable medical service that is important to patient health. The administration claims it doesn't want to stop that. It does want to regulate the larger compounding pharmacies such as the New England Compounding Center whose contaminated medication resulted in 64 deaths and 750 illnesses from meningitis in 2012.
"They are manufacturing," Chester explains about NECC, adding that the company is not performing traditional compounding. "When you mass produce and it's no longer one prescription for one person, then you're manufacturing."
Proposed legislation to prevent another NECC scenario includes a bill co-sponsored by Rep. Morgan Griffith, R-Virginia, Rep. Gene Green, D-Texas, and Rep. Diana DeGette, D-Colorado, that seeks to put pharmacies like NECC into the manufacturing category for FDA oversight but wants to protect traditional compounding pharmacies. "I agree," Chester says. "I think that's fair."
Reinhardt agrees, too, but she wants to make sure any new legislation doesn't adversely affect the types of compounding that she and other individual pharmacists perform. "There's still some work to do," she confirms.
"It's a triad," explains Cindy Reinhardt, a compounding pharmacist at Black Oak Pharmacy in Medford. "The patient, physician and pharmacist work together to come up with an appropriate medication to fit the patient's needs."
According to the Professional Compounding Centers of America, at one time, nearly all prescriptions were compounded. With the advent of mass drug manufacturing in the 1950s, compounding rapidly declined. The pharmacist's role as a preparer of medications quickly changed to that of a dispenser of manufactured dosage forms, and most pharmacists were no longer trained to compound medications. But the one-size-fits-all nature of many mass-produced medications meant that some patients' needs were not being met.
In the 1990s, compounding started making a comeback. The International Academy of Compounding Pharmacists notes that the compounding industry now makes up an estimated 1 percent to 3 percent of the $300 billion U.S. prescription market.
A national survey of independent pharmacists showed that 76 percent compound medications for patients.
"Every individual is different," says Rick Chester, a pharmacist and co-owner of Medicap Pharmacy in Talent. "Every person reacts differently to medications."
There are several reasons why compounded medications are necessary. When a large pharmaceutical manufacturer discontinues a medication, there are still people who need it. A compounding pharmacist can recreate that medication by compounding it.
Some people are allergic to or intolerant of an ingredient commonly found in the commercially manufactured form of a medication including lactose, preservatives, dyes, gluten and sugar. A compounding pharmacist can create a personalized medication, formulated to give the needed treatment while leaving out the problematic ingredient.
Some medications have an unpleasant flavor, which makes the patient less likely to take it as directed. A compounding pharmacist can flavor many medications to make them taste better without compromising the medication's effectiveness. This is often used for young patients and even pets.
Sometimes the form of the medicine is the problem. Patients who have difficulty swallowing pills, for example, might prefer it as a flavored liquid. Some medications can be compounded in a topical form such as a cream or a gel that allows the medicine to be absorbed into the bloodstream through the skin.
The FDA doesn't oversee compounding pharmacies, and compounded medications are not FDA-approved. This is because every compounded medication is mixed on an as-needed basis for an individual patient. Even when a pharmacist mixes two FDA-approved drugs, the result isn't an FDA-approved drug. "That's a new drug," Chester says. "You've changed the formula."
The Oregon Board of Pharmacy regulates and inspects compounding pharmacies in the state. "They make sure we're using the right quantities of the right ingredients," Chester says. "I check every ingredient. I check the weights. I check the products. Every prescription that goes out has had every step checked by a pharmacist."
Offering compounded medicines fills a need in the community, Chester believes. "I know that every individual is unique," he says. "From time to time, they need unique products." Reinhardt concurs. "I love working one-on-one with patients," she emphasizes, "and helping them to achieve a better quality of life."