Sonoma County Medical Association
Frank Hench, RPh
A 67-year-old woman with ovarian cancer is admitted to hospice. Because of her extreme nausea and vomiting, she can no longer take medications by mouth, and her family finds it difficult to administer rectal medications. After a consultation between her doctor and a compounding pharmacist, a percutaneous cream of lorazepam, haloperidol, diphenhydramine, metoclopramide, and dexamethasone is applied to her wrist, and her symptoms are controlled.
Another woman is allergic to dyes, lactose, and animal-source gelatin capsules contained in many of the manufactured drugs that she requires for thyroid replacement, including l-thyroxine. The pharmacist compounds a lactose- and dye-free formula, dispensed in a vegetable-source capsule.
A middle-aged man has severe degenerative disc disease. Levodromoran is the only drug that mitigates his pain, but it is no longer available because of recurring manufacturing supply problems. The compounding pharmacist is able to procure the raw chemical and formulate a capsule containing the appropriate dosage.
These are just a few of the myriad problems that compounding pharmacists solve each day. Their skill—called extemporaneous compounding—allows them to prepare custom dosages that are unusual, unique, or otherwise unavailable. These compounds are often less expensive and more palatable than manufactured drugs.
Some of the earliest references to pharmacy are related to compounding. Exodus 30:25, for example, advises, "And thou shalt make it an oil of holy ointment, an ointment compound after the art of the apothecary: it shall be a holy anointing oil."
For thousands of years, drugs were prepared by apothecaries knowledgeable about dosage forms. As recently as the 1940s, approximately 60 percent of all medications were compounded; but with the advent of drug manufacturing in the fifties and sixties, compounding decreased, and the role of the pharmacist went from apothecary to dispenser. By the early eighties, compounding was almost nonexistent. Pharmacists began to focus more on the drug than on the dosage form, and the apparent need for compounding gradually declined.
In recent years, however, pharmacy has witnessed a resurgence in extemporaneous compounding, despite the profound influence of pharmaceutical manufacturers. Because of the costs of sustaining commercially prepared drugs in the marketplace and introducing new products, many drugs have been discontinued by their manufacturers, and others have become intermittently unavailable. Compounding pharmacists have stepped in to fill the continuing demand for these products. Pentobarbital suppositories, ergotamine sublingual, and propantheline are but a few examples.
When Prozac arrived on the market, many physicians wanted lower doses than 20 mg, which was the only available dose at the time. Compounding pharmacists were able to change the dosage to lesser strengths. Dosage changes were also made to prometh-azine percutaneous gel, progesterone suppositories, and spironolactone liquid, among others.
Pharmaceutical companies often formulate drugs according to marketing strategies and to the statistical average of patient needs; but many patients have specialized needs. Aller-gies and intolerance to lactose, preservatives, propylene glycol, dyes, and scents can affect outcomes from medication. If the bulk chemicals are available, compounders can reformulate products to make them lactose-, preservative-, or dye-free. Glycerin, olive oil, or other hypoallergenic vehicles can be substituted for the wetting agent in creams. Alternative means of administering medications can be formulated for improving clinical effect and patient compliance.
Possibly because of discouraging results from recent studies on synthetic hormones, many women are shifting to bioidentical hormones for hormone replacement therapy. Compounders can mix bioidenticals into capsules, percutaneous gels, suppositories, sublingual troches, and tablets, and they can titrate the dose to each individual.
For patients seeking alternative medical treatments, compounders can formulate medications not readily available in the United States. Drugs such as tinidazole, piracetum, 4-aminopyridine, and DMSA, as well as various strengths of liothyronine used in the treatment of Wilson’s Syndrome, are all agents that require specialized compounding.
Compounding pharmacists work in a triad with physicians and patients. Unlike traditional pharmacists, compounders have additional training in formulation, compounding, and the use of sterile techniques. They know the chemical, physical, and microbiological properties of their preparations, as well as their storage and handling.
The facility used to compound medications contains several pieces of equipment and a large inventory of raw chemicals. The equipment includes a mortar and pestle, beakers and graduates, suppository and troche molds, a magnet-stirring hot plate, an electronic balance that can weigh to the smallest quantity, a printer to record these weights, an electronic mortar and pestle, a high-speed blender, an ointment mill, a pH meter, a tube sealer, a capsule machine, and a laminar air-flow hood for sterile work.
Checks and balances are the key to accurate compounding. When the pharmacist receives an order for a compound medication, he or she first determines whether the written formula is on file or if additional research is needed. When the correct formula is found, the pharmacist calculates the amounts for each ingredient. The ingredients are weighed with an electronic scale, and a print-out showing the exact weight is made. When the print-out is completed, the pharmacist checks the weights, ingredients, lots, and expiration dates against the formula and the prescription. This "compound check" is then initialed and recorded in a log book.
Each step of the compounding is checked and recorded by the pharmacist, as is the final product. If there is a recall on a chemical that was used, the compounds can be easily found via the log book, and the patient can be notified. Random compound samples are occasionally sent to an independent lab for analysis of sterility and potency.
One of the most common compound requests is for hormone replacement therapy medications. Capsules, percutaneous creams, suppositories, and troches containing a selected mixture of estriol/estradiol/estrone (tri-estrogen) and/or progesterone, testosterone, DHEA, and pregnenolone are often prescribed. Testosterone replacement therapy is also available in flexible dosing modalities.
Pain-management compounds make up another large area of prescriptions. Consider the patient requiring 130 mg of hydrocodone daily for adequate pain control. Commercial versions contain acetaminophen, which could lead to liver damage. Compounders can prepare acetaminophen-free hydrocodone capsules. Creams containing ketamine, gabapentin, clonidine, and lidocaine have been successfully used for diabetic and herpetic neuropathies. For inflamed muscles and joints, NSAIDs such as ketoprofen, naproxyn, and diclofenac have been formulated into gels and applied locally with impressive results. Other requests for pain management include buprenorphine troches, ergotamine sublingual tablets, and hydromorphone oral solution.
Other commonly requested prescriptions include:
The International Academy of Compounding Pharmacists states, "From an historical perspective, compounding is the embodiment of the art of pharmacy, which is having the ability and skill to provide a medication in whatever form necessary to treat a patient’s exact need."
Compounding pharmacists can play an important role in the improvement of patient therapy. Instead of attempting to fit a patient with a commercial dosage form, the compounder can design a dosage for an individual patient’s unique needs.
Mr. Hench is a compounding pharmacist at Dollar Drug in Santa Rosa.
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