- Associated Press - Friday, August 5, 2016

LOGAN, Utah (AP) - At the age of 2, Colby Amundsen of Logan suffered a stroke, robbing him of his physical functions and ability to talk. His mom Erin is his chief caretaker, and makes sure he gets food and the medications he needs.

Now 11 years old, Colby is down from taking 14 medications when he was born to only six, but some of the doses require such small amounts of specific ingredients that they need to be made by compounding, reported the Herald Journal (http://bit.ly/2aNIGgV). For example, Colby needs 0.8 milligrams of artane in each dose (which he takes four times a day, whereas a pill typically contains two milligrams).

“They’re such tiny pills that even if I cut them in half, I’d never know if I got the exact dose, so by compounding, I can give him the exact dose he needs,” Amundsen said, noting if she could not get the drug compounded, it could lead to all kinds of side effects for Colby.

“I don’t have to worry about an overdose or an under dose; (compounding) makes his medication consistent, and that’s what he needs - consistency.”

Amundsen is one of an increasing number of people in Utah and elsewhere taking advantage of compounding - the pharmaceutical science of making a drug tailored to the individual patient’s needs by combining, mixing or altering ingredients.

“To me, that’s the art versus the medicine,” said D’Anne Moon, a nurse midwife who works at the Cache Valley Women’s Center in Logan. “The art of medicine is taking the science you know and applying it to each individual person, because every person is unique. Compounding is really the art of medicine and figuring out how to make this work with individual patients.”

Increasing popularity

Compounding used to be popular in the olden days, before major drug companies started manufacturing “cookie-cutter” medications, according to Shaun Klomp, a technician at Spence’s Pharmacy, 550 E. 1400 North, Logan.

But now, he said, compounding is making a comeback to help solve medical issues that those one-size-fits-all medications cannot - and Klomp is seeing that trend right here in Cache Valley.

“In the last decade compounding use has grown tremendously as more physicians and patients look for solutions to problems not easily solved by commercial drugs,” Klomp said. “Many medical disciplines that involve hormone therapy, pain therapy, dermatology, pediatrics, even veterinary have included compounded medications as a common prescribing practice.”

Medications from compounding can come in all different forms: capsules, creams, ointments, gels, nasal sprays, eye drops, sterile injections.

Klomp said compounding is ideal when standardized medications don’t work for patients.

“One size does not fit all; everyone has specific needs,” Klomp said. “A lot of the time (commercial) medications work. However, there’s a lot of people out there that need something that’s customized to them.

“What about those specific patients where a pallet doesn’t work for them? There can be certain issues and problems with the patient and the doctor wants to try a different route to make therapy more effective,” Klomp said.

Moon said hormones are the most common thing she compounds at Cache Valley Women’s Center.

“Sometimes there’s just not a product available that will meet the needs of my patients,” Moon said. “If I have a patient that comes in and maybe the medication is too strong, too weak, maybe they’re allergic to an ingredient, then I’m limited in what I can give them. That’s when I have to use the compounding pharmacy. Some things work, some things don’t but I generally have very good results with compounding.”

Moon talks with the pharmacy in charge of compounding the medication before it’s given to the patient.

“I say, ‘OK, I have these ingredients I want to put in,’ and the pharmacy helps me to pick the base that we’re going to put it in and then, with these ingredients, we figure out, ‘how much of this base am I going to need?’” Moon said. “Over the years, you develop an idea of how to do it.”

Amundsen, who wasn’t familiar with compounding before such medication was prescribed to Colby, said compounding has made a true difference in the health of her son.

Regulation and risk

Moon said compounded medications are not approved by the Food and Drug Administration, so that’s why it’s important to work with a “reputable pharmacy” that has technicians that understand compounding and how to do it.

Lyndsay Meyer, a press officer with the FDA, said compounded drugs are “not approved by the agency, and the FDA does not verify the safety, or effectiveness of compounded drugs.” Compounded drugs, she said, also “lack an FDA finding of manufacturing quality before such drugs are marketed.”

Meyer said state boards of pharmacy will “continue to have primary responsibility for the day-to-day oversight of state-licensed pharmacies that compound drugs in accordance with the conditions” of agency regulations.

Klomp said compounding pharmacies are able to make compounded medications because they are regulated by local state boards and licensing departments.

Safety is an important factor in making compounded medications, Klomp said.

“You always want to do extra research beyond those regulations,” Klomp said. “Like any industry, mistakes can be made.”

The risks of compounding medications recently came into the spotlight when an 8-year-old Denver boy with Sensory Input Disorder died after taking medication prescribed to him and made by a pharmacy.

Jake Steinbrecher’s parents are suing the pharmacy and pharmacist, alleging the boy died of an overdose after the pharmacy mixed the clonidine into the liquid at 1,000 times the boy’s prescription. His parents hope the lawsuit will lead to increased regulations of compounding pharmacies.

Amundsen said she’s heard about Steinbrecher’s story.

“That’s every parent’s worst nightmare,” she said.

As for risks of compounding medications, Amundsen said it’s low on her list of worries.

“You develop a trust with your pharmacy and he needs his medicines to stay alive, so there has to be some trust in the medicines themselves,” she said. “If you stop and think about all of the things that could happen with compounded medication, you could paralyze yourself with fear. I try not to think about it because so much is going on right in front of me.”

Klomp said such medication errors can be “horrific.”

“The chain of events in receiving a medication, from physician to pharmacist to patient, involve hundreds of steps,” Klomp wrote in an email. “There are a number of causes of medication error and just like any other industry, causes for errors are usually human. Check and balances within the system of pharmacy is critical for patient safety, and that does not just involve compounded medications.”

Klomp said pharmacies need to make sure the medication is dispensed correctly to avoid harmful or deadly errors to patients.

“We have developed a system of checks for our compounded medications so they end up being checked at most seven different times before being dispensed. Two of those times are hand calculations that are compared from two different individuals at the pharmacy,” Klomp said. “Any pharmacy should have a thorough quality assurance and control program for medications, both commercial and compounded, and nothing should be left to assumption.”

Amundsen tries not to think about the risks associated with compounding; she just tries to be a good caregiver for her boy.

“I wouldn’t have someone else come in and do it; he almost died and I’m counting my blessings every day, so along with that comes the extra responsibility and I’d gladly take that over him not being here.”

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Information from: The Herald Journal, http://www.hjnews.com

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