Compounding Pharmacies

A century ago, well before there were chain drugstores on every corner and shelves stocked with manufactured pharmaceuticals, town druggists would create prescriptions based on a list of ingredients provided by a doctor.

Today, things may be a lot different, but there are still pharmacists who create custom prescriptions—although now they do so with 21^st-century equipment and research. These pharmacists are called compounding pharmacists, and they fill a unique niche in the pharmacy world by offering personalized products to patients for whom certain commercially available products don’t work.

Boutique Medicine; Filling the Gaps

These days, most medications are manufactured in factories where consistency is critical; every patient with a prescription for, say, 80 mg of Oxycontin is going to get the same basic bottle of pills. This is a very efficient model of drug production that benefits the majority of people. Occasionally, however, a person’s needs may be unique.

Consider the following scenarios in which a commercial prescription would not be ideal, or safe:

° The patient cannot tolerate the side effects of the drug.

° The patient is allergic to an ingredient, such as gluten, corn or dye, in the drug’s formula or coating.

° The drug is available only in pill form, and the patient has difficulty swallowing.

° The patient is an infant or young child and needs a customized dose.

° The drug the patient needs is currently off the market.

These are a few of the more common instances when a compounded drug would be the most beneficial choice, says Bryan Prescott, PharmD, consultant pharmacist for the Pharmacy Consulting Department of the Professional Compounding Centers of America (PCCA).

“Mass-produced prescription products are vitally important,” says Dr. Prescott. “Compounders aren’t here to replace those entities; we’re here to fill in the gaps when traditional treatments don’t offer patients the delivery or effects they need.”

Special Delivery

According to Scott Karolchyk, MS, RPh, past president of IACP (International Academy of Compounding Pharmacists) and vice president of formulations at QmedRx, there are a lot of people whose needs extend beyond commercially available drugs—and of these people, chronic pain patients are a large percentage.

“Chronic pain is notoriously difficult to treat,” says Karolchyk. “Perhaps the medicinea patient is taking isn’t properly targeting the pain. Or maybe it is, but the side effects are unmanageable.” These are instances in which compounded drugs can complement the mainstream drugs, say Karolchyk and Dr. Prescott.

A patient taking a high-dose opioid for back pain, for example, might be getting pain relief from that drug. However, it might be at the expense of day-to-day functioning. In such a scenario,a compounding pharmacist can work with that patient’s doctor to devise a different delivery of the drug that will reduce side effects while still addressing the pain. So, for example, the doctor might reduce the dosage of the prescription opioid the patient takes by mouth, but ask the compounder to create a topical formula that will be applied directly to the site of the pain.

“When you take a drug orally,it’s distributed throughout the body,” says Dr. Prescott. “If the pain is in your back, why do you need pain relief in your elbows, ears and feet, and everywhere else? You can still stay on that oral medication and get that central effect, but a targeted topical pain treatment at the siteof the injury can allow your doctor to reduce your oral dosage and help you experience fewer overall side effects. And best of all, you have concentrated pain relief in the exact location you need it.”

Of course, some patients are able to eliminate oral pain medicine altogether. This was the case for Sarah Gentner of Baltimore. Due to Osgood Schlatter disease in childhood and later injuries including IT (iliotibial) band damage and a meniscus tear, she had suffered from chronic knee pain since she was a preteen. Gentner also has chronic back pain that resulted from a work injury. As a result, she was initially prescribed Percocet, an opioid-containing pain reliever, and Flexeril, a muscle relaxer. However, she was often unable to take the drugs due to the side effects.

“I found myself having to weigh whether I’d be able to handle the side effects based on what I’d have to do that day,” says Gentner. “My commute is over 40 minutes long, and my work is technical. With these drugs, I have to worry about drowsiness and cognitive function—it takes me much longer to process things. There were many times I’d have to choose between being in pain or being able to function and take care of my responsibilities.”

Gentner says her doctor tried putting her on a high-dose anti-inflammatory as an alternative, but that drug wreaked havoc on her stomach. In pursuit of additional therapies and overall wellness, Gentner started seeing an integrative pain physician, who prescribed a custom compounded formula designed for her. She has been using it since 2013 and has found it to be an invaluable tool for pain relief.

“It’s wonderful,” she says. “I just rub some onto my knee or lower back, and within 15 minutes I feel relief. It doesn’t make me drowsy, slow my cognitive skills or give me other side effects like constipation. I can take it at work or while I’m driving without having to worry about being able to function and focus on other tasks.”

Targeted Delivery

Targeted drug delivery is one of the biggest benefits of compounds, says Karolchyk. “Not only is the medication more targeted, but the patientis more likely to take it consistently when there are fewer side effects. That kind of compliance enhances pain relief.”

Gentner combines the compound with physical therapy. For other non-pain-related conditions and symptoms, she still uses commercial drugs—with the exception of her estrogen prescription, which she takes in compounded form.

“Compounding is rarely a replacement for mainstream pharmacy services,” says Dr. Prescott. “It works best as a supplement to it.”

Every pharmacist is taught compounding in school,and every pharmacy has the leeway to provide compounded prescriptions, says Karolchyk. You may even find some retail pharmacies that offer both commercial and compounded drugs. These are known as hybrid pharmacies. Typically, however, pharmacists who concentrate on compounds tend to work in or run compounding-only pharmacies.

Just as compounders offer customized drugs not available at mainstream pharmacies, mainstream pharmacies offer prescriptions that compounders don’t. If you need a name-brand drug in its existing formula and delivery method, you’ll need to go to your regular pharmacy to have that prescription filled. Compounding-only pharmacies don’t offer copycat versions of commercially available drugs. What they do is create new formulas using the active ingredients of existing drugs.

“Commercially available medications are made by manufacturers; compounded medications are made from scratch by the compounding pharmacist,” explains Karolchyk.

“If there’s a commercial product that will suit the needs of the patient, we won’t replicate it,” says Dr. Prescott. “There’s a ton of time, effort and money that go into developing those products. Undercutting those drugs would ultimately damage the entire research and development process for pharmaceutical products.”

Compounders do step up in case of drug shortages,however. Karolchyk says there are around 450 commercial drugs that are currently off the market. Compounding pharmacists can create those drugs.

“Drug shortage is a major issue we address,” says Dr. Prescott. “We keep our ears to the ground to see where there might be shortages. And if there is one, we’re ready to step in and help with that.”

In addition to the already-discussed topical preparations, such as gels and creams, compounding pharmacists can also create injections, liquids and suppository deliveries of certain drugs. Or, they can make an oral tablet or capsule with different coatings and filler ingredients. While compounding pharmacies have existing formulas they use, they’re willing to make modifications for patients, says Karolchyk.

The Communication Triad

If you think compounding might be right for you, talk to your physician. It’s always important that there be open communication between a doctor, patient and pharmacist. This is especially true when compounding pharmacists are involved. Because they aren’t administering a pre-made product, they need to be highly aware of what the physician is requesting and what the patient needs.

“We operate on a triad,” says Dr. Prescott. “It’s not just a case of the doctor calling in the prescription. The compounding pharmacist needs to be in direct contact with both the patient and the doctor. And the doctor and patient need to be communicating well, too. Everyone is on equal footing to discuss therapeutic concerns, cost concerns and anything else that comes up.”

“The pharmacist should be viewed as a key partner in the patient’s care,” agrees Karolchyk.

Accreditation

Many compounding pharmacists are accredited by the Pharmacy Compounding Accreditation Board (PCAB), or another accreditation organization. Not only are compounding pharmacists educated in compounding, they are also up to date on drug studies and modern compounding methods. Dr. Prescott’s organization, PCCA, is a resource for compounding pharmacists. Members have access to the association’s research, computer equipment and raw materials.

“It’s important to remember that compounding pharmacies are regulated just like everyone else,” says Karolchyk. “But I would always recommend using pharmacies that are accredited. The accreditation bodies ensure the pharmacy is using the right equipment, suppliers and testing. Also talk to your doctor to see which compounding pharmacies he or she has a good relationship with.”

“Compounding pharmacies are very research driven, but that level of oversight that comes with accreditation is important,” says Dr. Prescott. “Members of our organization also have an extra edge based on the education and resources we provide.”

The Cost of Custom Rx

When considering going the compounding route, it’s also important to discuss cost with your doctor, pharmacist and insurance carrier. Most compounding prescriptions are moderately priced. They don’t carry the hefty price tag that comes with the extensive research and development of new commercial drugs. However, unlike pharmaceutical companies, they don’t have the cost advantage of mass production.

Karolchyk points out that compounded drugs can reduce costs over time. “If you’re taking five or six drugs for your pain, and a topical cream helps you reduce that number to one or two, then you’re saving money on those monthly copayments.”

Dr. Prescott agrees. “The quicker a compound can get the patient out of the acute disease phase, the less expensive treatment will be overall.”

Each compounding pharmacy sets its own prices, so it may be beneficial for a patient to do some research. This is no different from retail pharmacies, which also vary quite a bit in price. Compounding pharmacies can provide the cost of a particular prescription and may also be able to work with you on the price of refills.

In addition, contact your insurance carrier to see if they’ll cover a compounded prescription. Dr. Prescott says coverage is variable, but patients are often surprised to find they can receive at least some reimbursement. He says Medicare will pay for a compound if the pharmacist used a manufactured drug in the creation of it.

Gentner says her prescription drug coverage includes coverage of her compounds, so she only has a copayment to worry about.

Room to Grow

Doctors are becoming more aware of compounding pharmaciesas a valuable component of patient care particularly when it comes to pain management. However, it’s still an underused resource.

“According to the Archives of Internal Medicine, 5 percent of patient in the United States need a compound but don’t have access to one,” says Karolchyk. “And only 1 percent of patients currently take a compounded medication.”

“Pain management doesn’t come in a one-size-fits-all pill,” says Dr. Prescott. “Talk to your doctor about compounds. If a patient is still in a lot of pain, an alternative medication may be just what the patient needs.”

“By tailoring a drug specifically for a patient, we can help that patient achieve real relief,”says Karolchyk. “We don’t want to just make a dent in the pain,we want to make a real difference. Our goal is to work with the doctor and patient to bring that pain level down to a 3 or lower.”

Gentner is happy with the pain relief she’s experienced due to her compound. “It’s targeted, there are minimal—if any—side effects, and it’s fast acting,” she says.“All of those factors are deeply important to me. I’m still very young, and I need this body to last.” {PP}