It was on the front page of my newspaper. It is in the data services I subscribe to for the American Society of Health-System Pharmacists and the American Society of Clinical Oncology. It is the feature of a new survey from the Hematology Oncology Pharmacy Association and is the lead-in for the Pharmacists’ Newsletter. It is on the nightly news, and it was explored in depth in the last issue of the Journal of Hematology Oncology Pharmacy (JHOP).
What exactly is this “it,” you may wonder. The drug shortage, of course. For pharmacists involved in any way with drug procurement, this shortage has been a source of extreme consternation, fear, apprehension, and frustration. Even the general population is becoming alarmed by drugs that are no longer readily available. We have an advanced civilization, but we apparently cannot figure out how to reliably provide some of the cheaper drugs that have significant impact on patient care. Or at least that seems to be the message that is promulgated today.
During a 30-minute newspaper interview on this issue at the end of August, I had to redirect the interviewer on 3 separate occasions to avoid inaccurate and sensational tendencies in the story. I reiterated 3 times that this was a national issue not unique to my center, and all the regional centers around us had the exact same (and in some cases worse) scenario. Nevertheless, what appeared on the front page of the published article was that my hospital was unable to treat patients with cancer, because of my inability to get drugs. Ironically, the day the story appeared in print, I received shipments of the main 2 drugs (liposomal doxorubicin and paclitaxel) that had caused us serious problems.
I have read stories about drug mark-ups in the gray market, and about the concern with the safety of the current drug supply. Michael R. Cohen, RPh, MS, president of the Institute for Safe Medication Practices (www.ismp.org), has just presented a teleconference on this subject. MSNBC posted a story on the drug shortage online in late August, and the more than 600 reader comments were vitriolic, bashing everyone from the current and past federal administrations to the evils of capitalism, and complaining that hospitals and doctors are “sticking it” to patients. Having now been involved as a Section Editor of JHOP and the author of the article on this topic that ran in the June 2011 issue of the journal, I believe I have some credibility in this regard. As such, the vast majority of the comments in the media were off base.
The drug shortage problems are complex and multifactorial; no single issue can be blamed alone. The Center for Drug Evaluation and Research is planning a public workshop titled “Approach to Addressing Drug Shortage” for September 26, 2011, but to date, the only expedient solutions appear to be focused on giving more authority to the government. Knowing that a problem is forthcoming may allow professionals to have better communication and planning, but giving more control to those in government who cannot balance a single budget (eg, the US Postal Service Office, Medicare, Social Security) makes me uneasy at best.
In addition, some colleagues in the pharmaceutical industry are worried that confidential marketing plans and strategies would be required to be divulged to federal agencies. Finally, although the US Food and Drug Administration (FDA) is not the primary culprit, it is certainly playing a role in this crisis with the increased regulatory scrutiny. Furthermore, the FDA has admitted that it only has 4 employees who are dedicated to working with generic approvals.
The pharmaceutical companies also have some burden to bear, but in a capitalistic system such as ours, the problem arises from taking a product that has little profit and removing whatever remains of that profit incentive, by imposing new rules and increased regulatory compliance. Add to the mix the unstable world in which many of these drugs are sourced and manufactured, and the situation gets even worse. Many generic manufacturers can no longer afford to compete if the drugs are manufactured in the United States, with labor costs being more affordable elsewhere.
The other concern is not controlled by manufacturers, but by payers. The federal government—via Medicare and Medicaid reimbursement—is the single largest payer in the world today. Remember that the average sales price (ASP) system is only a few years old, and all drug manufacturers must submit (or suffer egregious fines) the prices for all the drugs they sell to the United States, and the US government then publishes the ASP for each drug based on these drug prices.
That has a devastating effect on contracting and negotiating a drug price. The effect on profits has been curtailed by companies succumbing to pressure and conforming to a mean, even with a minimal profit for a time, but eventually looking for a better use of the company’s resources. Many times that means exiting existing markets, which results in the current drug shortage that is plaguing our system today.
Solutions are neither easy nor obvious, but we can hope that the coming summit will provide more than just giving the federal government even more power. In the meantime—brother, can you spare some paclitaxel?
Timothy G. Tyler, PharmD, FCSHP, Section Editor
Director of Pharmacy Services, Comprehensive Cancer Center
Desert Regional Medical Center, Palm Springs, CA
Author Disclosure Statement
Dr Tyler is on the Speaker’s Bureau of Bristol-Myers
Squibb and Eisai Pharmaceuticals