Product Compounding: Who Should Monitor?

You may have read an article inthe August 7, 2006, issue of USAToday entitled "Deaths SpurDebate about Drugs Made in Pharmacies."The article describes eventsover 10 months from 2004 to 2005,which suggest that sterile cardioplegiasolution compounded by a national compoundingorganization may have resultedin 11 patients contracting infections.The article was inflammatory and incompleteand in some ways failed to makeimportant points on the topic. Nevertheless,it was probably read by millionsof people and, in my opinion, tarnishedour professional image.

One important point was made, in thatresponsibility for the oversight of thequality of compounded products wasquestioned. The compounding pharmacythat allegedly was involved fell underregular FDA oversight, but the authoraccurately revealed that oversight ofsmaller compounding operations andhospitals are governed primarily by staterules and regulations, which vary substantiallyacross the country.A significantpoint that was not made was thebreadth and depth of the compoundingthat is done, including compoundingthat is done outsidehospitals.

Community and hospitalpharmacists always haveregarded it their right andresponsibility to compoundprescriptions to meet theirpatients' needs. Compoundedproducts go far beyond sterilepharmaceuticals, to includecapsules, topicals, ophthalmicproducts, and more. As pharmacyschool curricula havechanged, however, fewer newprofessionals have the interestand expertise to offer compoundingservices. As a result,many of us outsource thisresponsibility to compoundingpharmacies. In the majority of cases,these pharmacies uphold standards ofquality that we and our patients expect.We also assume that state regulatoryagencies provide the necessary oversightto protect the public.

Most of us know, however, that thereare far too many pharmacies that do notmeet our standards for quality and accuracy.We know that state boards of pharmacydo not monitor for the quality ourpatients expect, and they have beenreluctant to intervene proactively. Inmany cases, it is a matter of limitedresources. Most board inspectors, moreover,have limited expertise and experienceto ensure standard compliance andquality in all compounding pharmacies,but they do respond after alleged harm isdone. Boards themselves struggle withdeveloping guidelines and regulationsthat are intended to apply to compoundingpharmacies. I suspect that politics areinvolved in coming to grips with thisissue. Many independent pharmacistscontinue to offer basic (nonsterile) compoundingservices and do not encouragestate board involvement.

Something needs to be done. I amnot advocating more regulatory involvementat the federal level. I dobelieve that more of us need to partnerwith our state boards of pharmacy topursue a solution to this problem. If wefail to resolve the issue of compoundingpharmacies harming patients, wecan anticipate a loss for secundumartem and a limit on patient andprovider choices with federal intervention.I also can guarantee that ourimage will continue to deteriorate inthe eyes of the public, and we willdeserve the criticism.

Mr. McAllister is director of pharmacyat University of North Carolina (UNC)Hospitals and Clinics and associatedean for clinical affairs at UNCSchool of Pharmacy, Chapel Hill.