Chris Hutts, a pharmacist with Cantrell Drugs, is shown working in the cleanroom of Cantrell Drug Company’s compounding facility in Little Rock.

Compound drugs to meet individual needs can come at less cost

Currently there are hundreds of prescription drug shortages in the U.S, but hospitals and patients throughout Arkansas don’t have to go without prescription drugs because of the capabilities of state compounding pharmacies.

“Right now the FDA has identified hundreds of drug shortages,” said Chris Hutts, MS, Pharm D, director of product development, Cantrell Drug Company (www.cantrelldrug.com), Little Rock. “Some of these are life saving drugs such as medicine used to stimulate the heart after it goes into arrest. They have gone short so we are compounding them. Hospitals are desperate to get them. If a drug goes off the market for some reason – it may be backordered or there may be a problem with producing one of the ingredients at the manufacturing facility – we basically step up and fill the need for the consumers at hospitals by preparing injectables.”

Only a few companies make sterile drug products. Shortages can be caused for various reasons ranging from lack of an adequate profit margin to manufacturing slowdowns at facilities while equipment is retooled.

Compounding is not manufacturing, but is the combining of ingredients into a final preparation. Hutts said that if compounding pharmacists can get the raw ingredients, they can, in most cases, prepare the medicines.

“It is just like following a recipe,” said Hutts, whose company employs about 40 people in an 18,000-square-foot facility. “We research the formulation, develop a formula, test the final preparation, and package it appropriately. We have plenty of technicians and pharmacists to provide oversight to check orders and make sure everything is done correctly. One thing that makes us stand out from a lot of other compounders is our quality assurance and testing. We have a very high standard that exceeds the standards of the market. We test every batch. Our quality is suburb. It lets doctors rest assured at night.”

In addition to providing drugs that have gone off the market, a vital service is providing alternatives for people who are allergic to a component of the drug. Compounders can produce the medication without the ingredient to which the patient is allergic.

“If you want it preservative free, we can make it without preservative,” Hutts said. “With children’s antibiotics, if they are allergic to dyes on the coating, we package it into clear gelatin without the ingredient they are allergic to. We can also adjust the dosage. If the standard dosage is 40 milligrams, and the patient needs 30, we can compound that.”

While they do retail compounding for patients and even for pets (pets don’t like to take pills so sometimes vets prescribe topical medicines), the bulk of their business is to hospitals as injectable formulations. 

Compounding isn’t new. In fact, back in the 1950s it was common.

Arkansas compounding pharmacies are making medicines not just for people in the state, but across the nation.

“Right now we are formulating a ton of medications that are on manufacturer backorder for hospitals, surgery centers and doctors’ offices all over the country,” said Becca Mitchell, PharmD, chief operating officer, US Compounding, (www.uscompounding.com) in Conway. “We are working licensed in 48 states. A good compounding pharmacist is an invaluable resource providing innovative, solution and customized care solutions using sophisticated established procedures.”

Mitchell said that the Arkansas Board of Pharmacy is very supportive of compounding.

“The Pharmacy Board is there to protect the public, but it also sees the value we provide to the healthcare system,” Mitchell said.

US Compounding specializes in injectables, and women’s health and pediatrics. Mitchell said they work with physicians to look at the whole person. For example, they work a lot with both men and women to get customized dosages of hormone treatments.

“We don’t claim bioidentical hormone replacement is safer than other hormone replacement alternatives, but there is a lot of scientific evidence to support bioidentical hormone therapy,” Mitchell said. “After the doctor has approved the customized hormone replacement plan, we get the patient started on hormone replacement therapy and then check continuously to make sure the patient’s hormones are balanced. A doctor would never put someone on blood pressure medicine and then never check on the patient’s blood pressure again, so we don’t just dispense a prescription and walk away. We even actually do work with several oncologists for hormone replacement for breast cancer survivors. Any time there is a history of any type of cancer, we make sure the patient’s oncologist is involved to evaluate the risk/benefit to the patient and oversee the therapy.”

Modern compounding has become very sophisticated through technology and processes said Mitchell. US Compounding welcomes practitioners to stop by their pharmacy at any time for a personal tour and demonstration of the quality assurance procedures, and to learn more about compounding.

Mitchell said they also work with universities on clinical trials, and with doctors who want to try a new therapy.

Pharmacist Lee Shinabery, owner of Shinabery’s Compounding Pharmacy, Jonesboro, said while a lot of doctors know about compounding, it is often not on the top of their minds when they run across a problem.

“The majority of doctors don’t think, ‘My patient has had trouble with this medicine. Let’s see what a compounder can do,’” Shinabery said. “It needs to become more widely known there are other options out there. Once doctors start using compounding and see how their patients benefit, usually they start a lot more patients using it.”

Shinabery said one reason compounding isn’t used more is that Medicare and Medicaid don’t cover compounds, while insurance companies may or may not.

“Pharmacists have compounded since the start of medicine, so why they don’t cover these things, I don’t understand,” Shinabery said. “Custom medicine is not overly expensive. The average prescription on the compounding side averages $42.”

Shinabery recommends medical professionals considering a compounder visit the facility to see how it works. Any pharmacy can compound, but are they set up to compound? Do they have a lab? Do they have the facility to make a top quality product? Where have they been trained? Facilities with a full laboratory—as opposed to someone compounding on a back counter—have better quality controls.

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