Editor's Note: Regulatory Reform to Eliminate IV Medication Errors?

JANUARY 01, 2009
James C. McAllister III, MS, FASHP

Mr. McAllister is a health-systems consultant based in Chapel Hill, North Carolina.

In mid-November 2008, the FDA rejected an appeal from Richard Daines, MD, New York State's health commissioner, and Thomas Frieden, MD, MPH, New York City's health commissioner, to ban the manufacture and distribution of multiple-dose vials. I was stunned to learn that they had even proposed such a notion, but I eventually learned that the proposal was well-intentioned, if not timely.

Apparently, a pain management physician in New York was in the habit of reusing syringes in treating multiple patients, causing at least one case of hepatitis C transmission. A public outcry arose when it was learned that the state health department waited 3 years to inform the public of that particular physician's practice. Although state and federal guidelines prohibit the practice, Drs. Daines and Frieden wrote the FDA commissioner and stated that, despite the existing guidelines and recommendations, some physicians continue to misuse needles and syringes, which can lead to the contamination of multiple-use vials.

This seems like the classic "throwing the baby out with the bathwater." As the FDA commissioner recognized in his response, multiple-dose vials "are an important dosage option for hospital pharmacies" that reduce cost, improve efficiency, and limit storage space requirements.

On a personal note, I have a family member who is being treated with a complicated and unusual chemotherapy regimen in his local oncologist's office. It is a satellite clinic with no pharmacist presence, so nursing staff compound all the intravenous (IV) admixtures. My wife "coaches" the patient and family to ask appropriate questions about the doses being administered, and we have been appalled at how little the nursing staff apparently knows about what they are doing. Even more troubling is that the nursing staff has very limited resources to consult, and they have become almost surly when the family asks questions. The problem is further compounded when drugs require reconstitution prior to making the final product for administration. Because we were concerned that a medication error had occurred that may have caused a temporary cessation of treatment, I consulted with the North Carolina Board of Pharmacy to determine whether medical boards typically have regulations and/or guidelines on IV compounding practices in private physicians' offices. I learned that the Pharmacy Practice Act defines a pharmacy as "any place where prescription drugs are dispensed or compounded." Offices compounding chemotherapy are plainly within the definition of a pharmacy and thus, on the face of the act, would require a pharmacy permit. Although boards of pharmacy with such language in their statutes technically have purview over compounding in the physician's office, my guess is that they are rarely, if ever, enforced.

The public, the press, and certainly practitioners in organized health care settings know that compounding IV drugs is a process with inherent and dangerous risks. It is time to convene a group or begin a process that includes all stakeholders, including medical boards, boards of pharmacy, boards of nursing, the pharmaceutical industry, and health system pharmacists to review current IV compounding practices, policies, and procedures and propose recommendations to ensure the quality of compounded IV drugs, regardless of the environment in which they are prepared and administered. This process should look forward to the practice of preparing individualized therapies from genetically derived drugs.

Let's use the proposal made by the health commissioners as an example. Eliminating the availability of multiple-dose vials for hospitals would cause significant problems in many ways. There is an emerging industry to produce technologies (robotic devices) that capitalize on the use of multiple-dose vials. We need to strongly encourage pharmaceutical manufacturers to continue to make multiple-dose vials available and, when possible, pursue formulations that do not require reconstitution. We should work with state boards of pharmacy to educate the public regarding what they should expect from their office-based physicians when injectables are administered in the office, because this is a growing phenomenon. It is time to take bold steps to improve IV therapy for all patients. What do you think?