Regulatory intervention may be necessary in order to guarantee the quality of compounded intravenous medications.
Mr. McAllister is a health-systems consultant based in Chapel Hill, North Carolina.
In mid-November 2008, the FDArejected an appeal from RichardDaines, MD, New York State's healthcommissioner, and Thomas Frieden,MD, MPH, New York City's health commissioner,to ban the manufacture anddistribution of multiple-dose vials. Iwas stunned to learn that they hadeven proposed such a notion, but Ieventually learned that the proposalwas well-intentioned, if not timely.
Apparently, a pain management physicianin New York was in the habit ofreusing syringes in treating multiplepatients, causing at least one case ofhepatitis C transmission. A public outcryarose when it was learned that thestate health department waited 3 yearsto inform the public of that particularphysician's practice. Although state andfederal guidelines prohibit the practice,Drs. Daines and Frieden wrote theFDA commissioner and stated that,despite the existing guidelines and recommendations,some physicians continueto misuse needles and syringes,which can lead to the contamination ofmultiple-use vials.
This seems like the classic "throwingthe baby out with the bathwater."As the FDA commissioner recognizedin his response, multiple-dose vials"are an important dosage option forhospital pharmacies" that reduce cost,improve efficiency, and limit storagespace requirements.
On a personal note, I have a familymember who is being treated witha complicated and unusual chemotherapyregimen in his local oncologist'soffice. It is a satellite clinic withno pharmacist presence, so nursingstaff compound all the intravenous(IV) admixtures. My wife "coaches" thepatient and family to ask appropriatequestions about the doses being administered,and we have been appalled athow little the nursing staff apparentlyknows about what they are doing. Evenmore troubling is that the nursing staffhas very limited resources to consult,and they have become almost surlywhen the family asks questions. Theproblem is further compounded whendrugs require reconstitution prior tomaking the final product for administration.Because we were concernedthat a medication error had occurredthat may have caused a temporary cessationof treatment, I consulted withthe North Carolina Board of Pharmacyto determine whether medical boardstypically have regulations and/or guidelineson IV compounding practices inprivate physicians' offices. I learnedthat the Pharmacy Practice Act definesa pharmacy as "any place whereprescriptiondrugs are dispensed orcompounded." Offices compoundingchemotherapy are plainly within thedefinition of a pharmacy and thus, onthe face of the act, would require apharmacy permit. Although boards ofpharmacy with such language in theirstatutes technically have purview overcompounding in the physician's office,my guess is that they are rarely, if ever,enforced.
The public, the press, and certainlypractitioners in organized health caresettings know that compounding IVdrugs is a process with inherent anddangerous risks. It is time to convene agroup or begin a process that includes allstakeholders, including medical boards,boards of pharmacy, boards of nursing,the pharmaceutical industry, andhealth system pharmacists to reviewcurrent IV compounding practices, policies,and procedures and propose recommendationsto ensure the quality ofcompounded IV drugs, regardless of theenvironment in which they are preparedand administered. This process shouldlook forward to the practice of preparingindividualized therapies from geneticallyderived drugs.
Let's use the proposal made by thehealth commissioners as an example.Eliminating the availability of multiple-dosevials for hospitals would causesignificant problems in many ways.There is an emerging industry to producetechnologies (robotic devices)that capitalize on the use of multiple-dosevials. We need to strongly encouragepharmaceutical manufacturers tocontinue to make multiple-dose vialsavailable and, when possible, pursueformulations that do not requirereconstitution. We should work withstate boards of pharmacy to educatethe public regarding what they shouldexpect from their office-based physicianswhen injectables are administeredin the office, because this is agrowing phenomenon. It is time to takebold steps to improve IV therapy for allpatients. What do you think?