17P: Choosing a quality compounding pharmacy

March 1, 2012

The words "compounding" or "compounded" are words heard more frequently in everyday medical practice and hospitals. What is compounding, and how does it benefit patients?

Key Points

The words "compounding" or "compounded" are words heard more frequently in everyday medical practice and hospitals. What is compounding, and how does it benefit patients? The intent of this article is to define what a compounding pharmacy is, how compounding can benefit patients, and to assist the reader in selecting a compounding pharmacy. Because compounded 17-alpha hydroxyprogesterone (17P) recently has been the focus of attention, this article will primarily address compounded 17P. However, other compounded formulations are often used in obstetrics and gynecology.

The National Association of Boards of Pharmacy (NABP) defines compounding as follows:

Compounding may bring to mind an image of a pharmacist leaning over a balance or mixing drugs in a mortar and pestle. But today's sophisticated, sterile compounding pharmacies look more like modern laboratories, with highly precise electronic balances and clean rooms with air many times purer than a typical operating room.

Although commercially available manufactured products are an effective way to treat the majority of patients, compounding-the creation of custom-made medications in the pharmacy-may be the solution to some medication problems, such as patient sensitivity to inactive ingredients, drug shortages, commercially unavailable medications, discontinued drugs, or doses that are not commercially available.

Allergy/intolerance

Some patients may respond to a manufactured medication but may not tolerate a particular excipient (ie, pharmacologically inactive carrier), dye, or base. This is not uncommon in medications applied to sensitive vaginal mucosa. A compounding pharmacy can prepare an alternative form of the medication using a different base or omitting ingredients to which the patient is sensitive. The pharmacy also can incorporate the active ingredient into a base the patient is known to tolerate.

Drug shortages

When a medication is not available from the manufacturer, a compounding pharmacy may be able to prepare an alternative preparation to meet the patient's needs. Recently, desiccated thyroid tablets used to treat hypothyroidism were in short supply due to manufacturing problems. Compounding pharmacies were able to obtain the active pharmaceutical ingredient and use it to prepare dosage forms to meet patients' needs during the shortage.

Commercially unavailable medications

Examples of compounded medications used in obstetrics and gynecology include progesterone suppositories for the treatment of infertility and boric acid capsules and suppositories used vaginally for treatment of Candida vaginitis. "All Purpose Nipple Ointment" or "Dr. Newman's Nipple Cream" are common names for compounded combinations of mupirocin, betamethasone, and miconazole or clotrimazole used to treat sore and infected nipples during breastfeeding. Pharmacies also prepare specialized medications combining topical amitriptyline, gabapentin, lidocaine, and estradiol for the treatment of vulvodynia.2,3

Discontinued medications

Manufacturers may discontinue making a medication for various reasons, such as economic considerations. In 1956, 17P was approved under the trade name Delalutin. Bristol-Myers Squibb stopped manufacturing the drug in 1999. In 2003, the Meis, et al trial was published; subsequently, at the request of prescribers, compounding pharmacies began to prepare compounded 17P.4