Critical shortages of prescription medication in the United
States (and globally)
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?
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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
|
Purpose
|
Surgical antibiotic for critical care
|
Hemorrhage prevention during surgery
|
Childhood disease prevention
|
Manufacturer
|
Fresenius, Sargent, Santos
|
American Regent, Hospira
|
Sanofi Pasteur
|
Length of Shortage
|
1 to 2 months
|
Unspecified
|
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. http://www.amazon.com/Unraveling-U-S-Health-Care-Personal/dp/1442222972
This article in no way provides medical advice.
