I am fed up! You must be too. One of our professional students presented her project to our Pharmacy Executive Group, which entailed writing a specific policy and procedure for dispensing a drug that is available only through a "special distribution" program. In addition, she created a learning module so that our entire staff could be "credentialed" for performing responsibilities related to the use of this drug in our hospitals. Listening to her presentation was a tipping point for me, because we have been required to establish similar policies for a growing array of products, including dofetilide, bosentan, epoprostenol, treprostinil, iloprost, abatacept, natalizumab, sorafenib, sunitinib, omazumab, deferasirox, thalidomide, and lenalidomide.
These "special distribution" programs usually are created by the pharmaceutical manufacturers, apparently endorsed by the FDA and most frequently defended on the basis of patient safety. The obvious common characteristic of most of these agents is that they are incredibly expensive. Many of these programs require specific educational or "credentialing" requirements for pharmacists, physicians, and/or nurses. Some programs require data collection and submission, special packaging and storage requirements, and, frequently, a unique dispensing procedure. As a result, our staff and your colleagues have to comply with a myriad of disparate policies and procedures, with which they must maintain familiarity on an ongoing basis.
I cannot dispute that educational and distribution requirements of special distribution programs reduce the potential for drug-related medication variances, but I suspect that they have been recommended to the FDA by the manufacturer. I will let the readers speculate on why manufacturers promote and implement special distribution systems and, further, why the FDA supports them.
I am baffled by the decision to impose these extraordinary requirements on hospitals and their providers. As one of my staff members commented recently, quinidine probably would not achieve FDA approval today without a special distribution system. As far as having a potential for serious medication errors, chemotherapy, anticoagulants, thrombolytics, and scores of other agents have profiles similar to agents that require special distribution programs.
Our hospital and its providers have developed and maintained a highly effective medication management system for all drugs. Admittedly, we continuously strive to improve, because no process is consistently perfect. I believe that creating these many new programs introduces opportunity for reducing access, delaying time of initial drug administration; consumes excessive resources; and adds cost to the health care system.
It is time to put a stop to the expansion of special distribution programs. I believe that manufacturers of drugs with special distribution programs should be held accountable to substantiate the value and need for existing programs on an ongoing basis. Finally, if the manufacturers and the federal government require compliance, which of the two will pay hospitals for the additional resources required for compliance?
Mr. McAllister is director of pharmacy at University of North Carolina (UNC) Hospitals and Clinics and associate dean for clinical affairs at UNC School of Pharmacy, Chapel Hill.