Ancient art in a high-tech world

The ancient art of pharmaceutical compounding originated from man’s attempts to seek relief from pain or protection from injury and death. As knowledge grew regarding the medicinal properties of organic and inorganic substances, ancient civilizations learned how to compound a variety of substances used for religious ceremonies and for making perfumes, as well as mixtures for staying well, treating the sick, and preparing the dead for burial. The alchemy movement gave rise to compounding drugs for medicinal purposes.

Compounding continued to evolve for many centuries. Large scale production of drugs began in the 1900s but by the 1950s, the commercial pharmaceutical industry was manufacturing drugs efficiently on a large scale and compounding was on the decline. Fortunately, the art of compounding was not lost, though it greatly diminished over the next 50 years. The pharmacist became the dispenser of drugs, rather than the compounder or apothecary.

The healthcare providers of today recognize the importance of customizing medications for the individual and compounding pharmacies are on the rise. Though the field requires more education, training and expertise for the pharmacist, it allows a return to the satisfying patient-pharmacist relationship in a specialized area of care.

Bill Johns’ fascination with compounding enticed him straight out of pharmacy school where, as a fresh graduate, he taught students about compounding in the labs at the University of Tennessee. In practice, he arrived at his focus on compounding in phases, launching his career in traditional pharmacy where he practiced for 20 years. He gradually incorporated more compounding, ultimately focusing on a compounding practice with a little traditional pharmacy for the second half of his 47-year career. In addition to his pharmacy practice, he has taught at the University of Tennessee College of Pharmacy and presently serves as a consulting pharmacist for major surgery centers. Williams C. Johns, Sr., DPh, FACA, FIACP, is the longtime owner of Peoples Custom Rx.

Why the evolution to compounding? “I found it more professionally fulfilling. We are in the business of helping people whose needs can’t be met in the traditional manner,” said Johns.

Established in 1969 as a traditional pharmacy, Johns’ transition to compounding engendered its renaming to Peoples Custom Rx in 1997. The pharmacy presently employs 13 and is a recent recipient of the Memphis Business Journal’s Small Business Award for 2011.

“Virtually all of our patients come to us by referral from physicians and hospitals. We also prepare medications for research, both human and animal, and we do a lot of veterinary work,” said Johns. Their business includes preparing medications not only for humans, but cats, dogs, birds and exotic pets as well as the zoo animals.

The demand for a ‘clean’ product

Compounded medications are required for many reasons. A pharmaceutical product may be unavailable commercially primarily due to lack of sufficient demand for profitability by the manufacturer or unavailability of the strength needed. And while the compounding pharmacists do perform dosage alterations from commercially made products, the bulk of the products made by Peoples Custom Rx are commercially unavailable. For example, “We can prepare gancyclovir as an intravitreal injection,” Johns said. “The drug is traditionally given for AIDS but it is also used for a resistant virus of the eye.

Given the incidence of allergies or sensitivities to gluten, dyes or fillers used commercially, the compounding pharmacy can prepare the ideal product devoid of chemicals or substances that can adversely affect the patient. “When we make a product from scratch, it is more pharmaceutically elegant,” claimed Johns. “We don’t use fillers and preservatives that manufacturers use, plus we can flavor our products when needed for patient compliance.” Some people have disabilities and can’t swallow medications. Fortunately, help is available across the broad spectrum of patient needs from a compounding pharmacy.

Hormone replacement therapy comprises a large part of the demand for services at Peoples Custom Rx. “We produce estrogen, progesterone and testosterone in several formulations: capsules, creams, gels, troches, and suppositories (vaginal). We make Tri-est, which contains all three estrogens estrone (E1); estradiol (E2), estriol (E3), Bi-est which contains estriol and estradiol, and then estradiol by itself.”  Different strengths are prepared, depending on individual needs of the patient, according to Johns.

“We also produce two products prescribed for some high risk pregnancies: progesterone suppositories and 17-alpha Hydroxyprogesterone Caproate injections,” he said.

“Testosterone therapy is also available for men in capsules, creams and gels. We also prepare erection dysfunction injections,” added Johns.

Pain management is another focus area for patients of all ages and is also important in palliative care. Compounding meets individuals’ needs for medications in non-traditional ways. “We provide medications for hospice patients who may be dealing with nausea, pain or an inability to eat. We make transdermal medications for pain or nausea when they can’t swallow. We make troches (lozenges) to deliver medications through the mouth mucosa and can formulate medications delivered into feeding tubes or TPN for infusion,” said Johns.

Children’s medications present special challenges relating to taste, fear of injections, difficulty swallowing, as well as the availability of proper dosage and in palatable form. Flavored suspensions, concentrates, freezer pops, “gummy bear” lozenges, and even lollipops for the younger set can be compounded and produced to improve compliance and eliminate spillage. Transdermal gels are also used for absorption through the skin.

Because of the smaller market for pediatric medications, lower dosages needed for children are not always commercially available. Compounding pharmacies provide smaller dosages and individualize the medication in a formulation that will work for the child. Johns recalled recently making a liquid form of Pepcid at a dose low enough for a four-week-old child. “We also prepare formulations for autistic children,” he added, who may have special sensitivities.

Sterile products comprise another area of concentration. Among the many sterile products prepared, Johns said, “We make intrathecal pump preparations and medications for patients. These products are very purified and go directly into the spinal cord area (via a small catheter). We also produce sterile ophthalmics. We prepare injections for various surgery centers, make eye drops with antibiotics and we prepare serum tears. The methodology for the tears involves the physician’s office drawing blood from the patient, spinning it down and then sending to us. We convert the serum into eye drops. It works very well because it is made from the patient’s own serum.”

Adjusting thyroid medications for patients can be a challenging task for physicians. “With thyroid medications, one strength does not fit all. We individualize strengths according to the patient and the physician’s orders,” said Johns.

Armour thyroid ® USP (Desiccated Natural Thyroid) is a natural, porcine-derived thyroid hormone replacement often prescribed as a first step in combination T4-T3 therapy for hypothyroidism if the synthetic thyroid supplements (levothyroxine alone or levothyroxine + liothyronine) are unsatisfactory or produce side effects. “Armour Thyroid is a combination T4-T3. If that balance is not right for the patient, you would want to consider compounding – we can adjust the percentages,” Johns indicated.

Various inhalation medications can be made including nasal antibiotics as well as ventilation therapies – often combining antibiotics with steroids. “These preparations are very effective because they are given in a formulation that is readily absorbed,” said Johns.

The compounding team

With over 120 years of combined experience and special training, Peoples Custom Rx has a small cadre of pharmacists and dedicated staff serving a multitude of customers’ needs. Their goal is to provide “personal service, preparing customized medications for customers using state of the art technology.”

When asked what might surprise physicians to know about compounding, Johns replied without hesitation, “Everything is done right here. We do old fashioned pharmacy with a high tech twist.”

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