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Friday, February 12, 2016

Drug Shortages in the U.S. and What We Can Do About It

Critical shortages of prescription medication in the United States (and globally)
The United States has chronic shortages of certain medicines, especially those used in critical care and surgical treatments. Recently, both the New York Times and the Wall Street Journal published articles on medication shortages. This analysis looks at current drug shortages, whether there are substitutions, the reasons for this phenomena, and what we could do about it. To help you understand the reasons for shortages in medications, I reviewed detailed information from the American Society of Health System Pharmacists, which tracks medications and posts an almost live-time report on drug shortages on its web site.[1] This chart shows several categories of drugs, both preventive and interventional medications which are in short supply as of February 2016.

Drug Shortages as of February 2016
Drug Type
Ampicillin injectable
Aminocaproic Acid Injectable
DtapIPVHib Vaccine

Surgical antibiotic for critical care
Hemorrhage prevention during surgery
Childhood disease prevention
Fresenius, Sargent, Santos
American Regent, Hospira
Sanofi Pasteur
Length of Shortage
1 to 2 months
In short supply since mid-January
Reason for Shortage
Increased demand
American Regent is no longer making it; Hospira indicated manufacturing issues
Manufacturing delay
Availability of Substitute
Yes, Unysn
None listed
Yes, Pentacel

Source: American Society of Health-System Pharmacists

The venerable Cleveland Clinic has a sterile room and the ability to compound its own drugs in a pinch, but this is certainly not the case with most hospitals.[2] Anesthesiologists must determine how to ration some drugs used in surgeries and hospitals should have a policy for determining this process. Still, much of it is in the dark, because when you consent to a hospital procedure, it is giving broad consent for the surgical team and the facility to make decisions for you while you are incapacitated in the procedure. This in and of itself isn’t bad, as it is a basic tenant of medical triage, and this is what the medical team is trained for. However, as a society, can we be doing more to assure adequacy of necessary medications and even preventive care immunizations?
 Mark Baum, CEO of Imprimis Pharmaceuticals, has some interesting observations, expressed in the January 26th Wall Street Journal Op Ed article.[3] His tenant is that federal regulatory policies interfere with free market competition for drugs and he has some interesting ideas to provide more of a supply of medicines and to lower the cost to the health system. He has several suggestions to improve the marketplace for less expensive drugs including:
1.       Allowing compounded-drug makers, which are companies who make the off-patent generic drugs, to create new formulations of expired patents for medicines and make them available at drastically reduced costs. This practice was not allowed until November 2013, when the Drug Quality and Security Act was passed.
2.       At present, Medicare or the Centers for Medicare and Medicaid (CMS), which is the largest drug purchaser in the nation, does not pay for compounded drugs, which means it is paying only for brand names, when a far less expensive substitute may be available. His example, Medicare will pay $750 for the Daraprim made by Turing Pharmaceutical, but not for the 99 cent generic alternative. I can just hear the swoop of lobbyists rushing for the beltway to scare Congress out of this good idea.
3.       Medicare also pays doctors a percentage of the cost of the drugs they prescribe, so there is no incentive for clinicians to prescribe the lower cost medications. This is especially true now when doctors are required to complete so much paperwork and receive so little in the way of reimbursement for primary healthcare.

 Since pharmaceutical manufacturers are privately held companies, often of a global nature, their entry into drug markets is controlled by the FDA, but their exit from the supply chain-not as much. Though the U.S. government is still one of the largest investors in healthcare research, through the department of Health & Human Services, product approval is regulated, but in general the drug companies use market pricing for their products. This means, if they have a monopoly, they can charge a lot more, which is what Valeant and Turing did, as detailed in a previous article.[4] Though Mr. Baum brings some good ideas to the fold, I don’t have quite as much confidence in the efficacy of the private sector marketplace as he does. Americans already pay more for their cardiac devices[5], orthopedic devices[6], and other medical gear than other nations, because these companies gouge the U.S. health system for the sake of their profits.  However, I am all for making the ninety-nine-cent pill available, as an alternative to the opportunistic price gouging of companies like Valeant and Turing. And finally, let’s stop blaming the physicians for everything, they are merely actors in a health system that rewards many of the wrong things and slights those that could make a difference. We need to focus on systemic changes and Congress should also pay the promised fee increase to physicians for primary care, which the Republicans refused under the budget sequestration process. Sequestration means the act of confiscating something or forcibly taking possession. It is unconscionable that physicians and health systems are encouraged by law, to provide health services, based on a certain rate of reimbursement and then jerked around by Congress in some power play.

And this is the healthpolicymaven signing off and encouraging you to share this article virally.
The healthpolicymaven is a trademark of Roberta E. Winter and Praevalere Inc. Ms. Winter is a healthcare writer and analyst and author of Unraveling U.S. Healthcare-A Personal Guide.

This article in no way provides medical advice.