compounding HOTLINE
Q:I have worked locum tenens in several different pharmacies,each of which makes various mouthwashesfor postirradiation pain and infections. These formulationsare FIRST, Malik's, Gillespie's, and Magic Mouthwashes. Isn'tthere one way to compound each of these preparations? Ikeep seeing differences among the pharmacies.
A:An advantage of extemporaneous compounding is itsflexibility?the pharmacist can tailor therapy to meeta particular patient's requirements. Usually, interaction withthe patient and physician is required to accomplish such targetedtherapy. The process of developing compounded formulationsrequires a pharmacist's special knowledge andskills.
"Magic Mouthwash" (for want of a better category name)formulations are as varied as the patients treated and theprescribers who diagnose. For example, postirradiationburns are often treated with a formulation of nystatin,diphenhydramine, lidocaine, and antacid suspension such asMaalox. Sometimes an antibiotic such as tetracycline isadded. A number of different regional names are applied tovarious formulations, and, within a region, variations on themain theme are often found. Stanford Mouthwash andPowell's Mouthwash are 2 such "named formulations," butvariations abound.
A central point to consider is that strict adherence to aparticular compounded formulation is important to providingconsistent care to a particular patient. When a particularformulation appears to provide relief for a patient, thatpatient should always obtain the same formulation compoundedthe same way.
Compounding differs from manufacturing?current GoodManufacturing Practices promulgated by the FDA requirestrict adherence to formulations in manufactured drug products.Extemporaneous compounding is not manufacturingbut is the province of the pharmacist. It should be carried outwith adherence to principles of pharmacy practice (cf USP28<795> and <797>).
E-mail your compounding questions tocompounding@pharmacytimes.com.
Mr. Erickson is director of professional affairs at Gallipot Inc.
