compounding HOTLINE

Author: Martin A. Erickson III, RPh

Q: I have worked locum tenens in several different pharmacies, each of which makes various mouthwashes for postirradiation pain and infections. These formulations are FIRST, Malik's, Gillespie's, and Magic Mouthwashes. Isn't there one way to compound each of these preparations? I keep seeing differences among the pharmacies.

A: An advantage of extemporaneous compounding is its flexibility?the pharmacist can tailor therapy to meet a particular patient's requirements. Usually, interaction with the patient and physician is required to accomplish such targeted therapy. The process of developing compounded formulations requires a pharmacist's special knowledge and skills.

"Magic Mouthwash" (for want of a better category name) formulations are as varied as the patients treated and the prescribers who diagnose. For example, postirradiation burns are often treated with a formulation of nystatin, diphenhydramine, lidocaine, and antacid suspension such as Maalox. Sometimes an antibiotic such as tetracycline is added. A number of different regional names are applied to various formulations, and, within a region, variations on the main theme are often found. Stanford Mouthwash and Powell's Mouthwash are 2 such "named formulations," but variations abound.

A central point to consider is that strict adherence to a particular compounded formulation is important to providing consistent care to a particular patient. When a particular formulation appears to provide relief for a patient, that patient should always obtain the same formulation compounded the same way.

Compounding differs from manufacturing?current Good Manufacturing Practices promulgated by the FDA require strict adherence to formulations in manufactured drug products. Extemporaneous compounding is not manufacturing but is the province of the pharmacist. It should be carried out with adherence to principles of pharmacy practice (cf USP 28<795> and <797>).

E-mail your compounding questions to compounding@pharmacytimes.com.

Mr. Erickson is director of professional affairs at Gallipot Inc.