Compounding costs

May 6—Compounding pharmacies can offer a life-saving medicine to patients who may not be able to take standard medication, but the industry is in the midst of challenges because of rules and regulations that have been put in place in recent years.

First, a step back.

Albuquerque is dotted with pharmacies and compounding pharmacies. Pharmacies we know, but what's a compounding pharmacy? The easiest answer is that compounding pharmacies mix medications for patients, or compound them. In that regard, they're different from the usual pharmacy, which distributes pre-made medications, usually from major drugmakers.

New Mexico Regulation and Licensing Department spokesperson Andrea Brown offered this definition in an email: "Compounding pharmacies combine ingredients to create a unique medication for a patient's specific needs."

Those specific needs can have to do with allergic reactions to an ingredient in a medication. The patient, Brown said, may not be able to be treated with an FDA-approved medication, which may cause them to have an allergic reaction. But the compounding pharmacy can, for example, remove the ingredient causing the reaction.

In that sense, such pharmacies are lifesavers. But some challenges exist.

Dale Tinker, executive director of the New Mexico Pharmacists Association, said cost may be an issue for some.

"Compounding has become a very expensive activity with the new pharmacy requirements that have been promulgated as federal requirements," he said.

The new rules essentially put in place more safeguards for compound pharmacists to follow when mixing drugs, and require that certain work be done in a sterile environment.

In the industry the new rules are known as USP 797 and USP 800. United States Pharmacopeia, USP, a nonprofit organization, sets the rules for handling medications and compounding practices, and new rules have been put in place in recent years. Many of the rules deal with safe practices and avoiding contamination of medications.

Updates to USP 797 went into effect in 2023 and include changes to policies, procedures and facilities making compounded medicines. USP 800's revision includes a description of the practices and quality standards for the handling of hazardous drugs. That was updated Dec. 1, 2019, and may be enforced by each state's Board of Pharmacy.

Industry publication Pharmacy Times further explains the differences between USP 797 and 800, saying the rules have driven many hospitals and compounding pharmacies to develop or revise policies on sterile compounding of hazardous chemotherapies and biotherapies.

According to Pharmacy Times: "In USP 797, the guidance establishes standards for sterile compounding to ensure accuracy and avoid contamination of sterile products. On the other hand, USP 800 highlights recommendations and processes for the handling of hazardous drugs and includes guidance for health care personnel and facilities."

Tinker said those revisions have had an effect.

"Very few do sterile compounding because the equipment requirements for a clean room are very expensive," said Tinker.

Modern Alchemist

Locally owned independent pharmacy Modern Alchemist Compounding Pharmacy serves both people and animals, which, according to owner Nawid Farhad, is something many compounding businesses do.

As far as the costs facing pharmacies seeking to comply with federal rules, Farhad said, yes, it could be expensive.

But he said he's all for stricter rules "to be able to provide better, safer, more effective options for patients."

"But as far as has it become difficult for people to outfit their existing laboratories and facilities, yes, because they had to go redo their stuff," Farhad said.

Farhad said he was fortunate to avoid having to revamp his pharmacy lab at 7900 San Pedro NE, because he opened relatively recently and was able to put in place needed operational safeguards.

"I opened the pharmacy in 2020, during the pandemic ... so I didn't have to go re-outfit my facility like others," he said.

His compounding pharmacy makes prescriptions that are customized and personalized for specific patients' needs, and that patient could be human or animal, Farhad said.

"Quite often they require a compounded preparation because they require specific dosing ... and generally we flavor it to make it more palatable with their preferred flavor," he said.

Regular pharmacies do not do compounding, but there are pharmacies that can do both, Farhad said.

What sets apart compounding pharmacies like his from traditional pharmacies is that there are no commercially available, manufactured drugs at his pharmacy.

"Things that are commonly available, we don't compound," he said. "We come in to fill the gap between what's commercially available and when the patient requires a specialized formulation."

Olive Tree

One pharmacy that has the clean room and other amenities is Olive Tree Compounding Pharmacy in Rio Rancho. Owner and pharmacist Ndidiamak "Didi" Okpareke said the cost of setting up and maintaining a pharmacy depends on the operation, because different pharmacies do different things.

"In terms of whether it's expensive or not, it's relative," Okpareke said. "It really just depends on the owner's practice and how it's been designed. ... It varies from business to business."

She has a special lab at her pharmacy for mixing drugs.

"In my new space I do have a clean room, which is also known as a sterile lab, which is where you can prepare injectable products," Okpareke said. "I was able to do it for the amount that it cost, but for another pharmacist it may be cost-prohibitive."

But, she said, cost is just a secondary factor.

"The primary factor is to make sure that as pharmacists and technicians we know what we're doing so that we're making products that are safe for our community members," she said. "I think those federal regulations were put in place to make sure that whenever we dispense medications that were made in a sterile environment that they are indeed sterile and no one is going to be harmed from them."

Okpareke has been in practice for 16 years and opened Olive Tree in 2017. With its growing client load, the 2,500-square-foot pharmacy has plans to fill out its 6,000-square-foot building.

How to get compounded medicine

"Anything that we compound requires a prescription from a licensed practitioner," Farhad said. "A physician, veterinarian, a nurse practitioner or PA. It works like a regular pharmacy practice where you get a prescription from your doctor's office and you come to the pharmacy. You cannot obtain a compounded preparation without a prescription."

Mostly, it's not covered by insurance.

"Here at Olive Tree Compounding Pharmacy, we don't have any insurance contracts," said Okpareke. "Typically, insurance does not cover the cost of compounded medication, so typically, the patients or clients, whoever needs compounded medication, they're paying out of pocket."

Farhad said his view is that the cost for patients is "not expensive" but is "relative." The reaction he gets from satisfied patients makes it all worth it.

"To me, for the amount of benefits they're getting from the compounding formulation, an average of 40, 50 bucks, it's way worth more than that."