“Personalized medicine is about… making smarter decisions to treat patients on an individual basis. Personalized medicine is the essence of compounding.”
— FDA’s Felix Frueh, Office of Clinical Pharmacology
From the time of Galen, the father of pharmacy, until the mid 1950s, all pharmacists made or “compounded” medicines, using their knowledge of chemistry, botany, physiology, alchemy, and the disease process. Compounding is still an integral part of their responsibility and their profession. The making of medicine has always depended on a collaborative relationship between patient, pharmacist, and doctor.
In the mid 1950s, pharmaceutical companies began manufacturing and marketing medicine for the masses. Because of their marketing claims, these medications gradually replaced many of the individually compounded prescriptions.
Some drug stores decided there was no longer a need for compounding, but many independent pharmacists continued expanding the science and art form, making medicines on the cutting edge of science, filling in the gaps for medication needs the drug companies could not fill.
Today, pharmacists use pharmacogenomics, which is individualized pharmacotherapy that takes into account patients’ genetics, biochemistry, and their ability to metabolize, utilize, and excrete the medications and toxins, as well as protein binding and receptor site status. This science can improve the selection, dosages, and effectiveness of medication while reducing toxicities and side effects. It also allows compounding pharmacists to change lives by making customized medications to meet needs of patients that commercial pharmaceutical companies cannot. Practitioners, consumers, and the FDA recognize the importance of individualizing medications and dosing the exact amount and form the physician and patient agree upon.
Reasons why compounding is a necessary part of our health care system:
- Drugs on demand. Drug companies cannot make every drug for every condition. Even if they could, they could not provide them on demand. Making sterile autologous eye drops with no preservatives out of the patient’s serum is one such medication. These drops are very high-tech, as their production requires specialized equipment, and sterile training, storage, and handling. Patients have typically exhausted all other tear producing, inflammation controlling options for eye-sight threatening dry eye syndrome. Not only do they find great relief, but their eye-sight is restored and preserved because of these customized compounded drops.
- Individualized dosages. Manufacturers make only a few select dosages. Some patients need dosages that vary from those commercially available. Having the option of a compounded individualized dosage is a great benefit for patients taking thyroid medication. Non-porcine T3 and T4 can be compounded in strengths and ratios that Armour® and Nature-Throid® cannot provide (i.e. they are only in a 4:1 ratio). This option also avoids the autoimmune problems created by pork thyroid glandulars.
- Allergy-free medications. Some patients have allergies or delayed reactions to the preservatives or fillers in commercially made products. They need to have medications made without extra chemicals so they can receive the benefits of the drug without side effects created by allergens.
- Individualized type of administration. A patient may need a different route of administration than the one commercially available. For example, a patient may not be able to take a medication orally and needs it compounded in a suppository, a topical form, or an IV. There are many everyday examples of recreating or switching dosage forms that make an important difference in people’s health, and therefore in their lives. More appropriate dosage forms can protect the patient’s organs of detoxification, such as the liver, gallbladder, lungs, and kidneys. Dosage forms also dictate the efficacy of a particular medication. One such example is a chronically hospitalized patient with severe GI issues that were leading to her ultimate demise as she could not take in nutrients orally or through feeding tubes. But when her doctor contacted a compounding pharmacy regarding the possibility of making an IV form of the amino acid L-glutamine, her life was changed, as she was finally able to recover enough to leave the hospital.
- Providing medications that have been discontinued. Some patients still need medications that have been discontinued by large manufacturers. Most often, they are no longer manufactured because the drug is no longer as profitable as it was in the beginning and the patent has expired. Compounding pharmacies can provide these medications in multiple dosage forms for patients who cannot afford or tolerate the newly patented and highly profitable drugs, or for whom the newer drugs do not work.
- Multi-drug therapies. Compounding pharmacists can incorporate several drugs together in one dosage form so the patient does not have to purchase several individual prescriptions. Compounding several medications into one typically saves patients money as they are not buying each medication separately. Take for example a compounded ear powder used for multi-pathogenic resistant ear infection. It could contain two to three antibiotics, one or more anti-fungals, and a pain-relieving anti-inflammatory agent. If purchased using only the commercially available products, a patient would have to buy 2-3 antibiotic prescriptions, plus one or more anti-fungal prescriptions, and a steroid prescription (5-7 prescriptions). Even with insurance, some copays are $20-$40 for each prescription. You can see how quickly that could add up for multiple drug regimens. Oftentimes, the cost of the combined compounded medication is dramatically less than trying to achieve the same effect buying multiple drugs with multiple copays. For instance, there have been times when combined drugs could be compounded in a dosage form for approximately 1/2 or less of the amount of the copays. On top of that, the patient would have to administer 5-7 different kinds of commercial drops into the ear canal. The compounded powder is administered in one application, without extra chemicals.
In another instance, numerous eye surgeons in the know are very pleased with compounded pre-op eye formulas that contain up to 6 ingredients in one medication. This not only saves money, but also saves 30 minutes worth of surgery prep time per patient. The potential reduction in the number of commercially available prescriptions filled is a major reason drug companies, via the FDA, are trying to get rid of compounding pharmacies.
- Providing commercially unavailable drugs. As the Wall Street Journal wrote on January 26, 2007, “Drug companies suffer from blockbuster-itis … even the most brilliant discovery may not be translated into a drug unless it has a 10 digit sales figure ($1,000 million).” Compounding pharmacists can provide medications that are deemed not profitable enough for drug companies to embark upon in the first place, and therefore not available commercially in the United States. Frequently, compounding pharmacists have come up with formulations that have later become commercially available drugs, such as Retin-A®, now made by Johnson and Johnson. Pharmacists created cyclosporine eye drops, now marketed as Restasis® and made by Allergan. Various minoxidil formulations are now marketed as Rogaine® by McNeil-PPC. Pediatric chemotherapies were created by compounding pharmacists. When these products became available commercially, they were 3-30 times more expensive than when they were compounded.
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The O’Brien Pharmacy Difference
At O’Brien Pharmacy, we have but one passion: to serve our global community. We are dedicated to extraordinary and individualized patient care, providing innovative, well documented, and highest quality medication and holistic solutions for practitioners and patients alike. We promote optimal lifestyle and healing with clinical consultations and the art and science of compounding without compromise. It is with gratitude and our greatest pleasure that we accept our role as a trusted cornerstone in healthcare since 1962.
O’Brien Pharmacy is non-sterile and sterile PCAB accredited.
O’Brien Pharmacy is a FDA-inspected and FDA-compliant facility.
5453 W 61st Place
Mission, Kansas 66205