The controversy over prescription drug shortages continues to rage as meds either remain unavailable for treatment and clinical trials or are being sold at high prices on the gray market. At least 15 patient deaths have been reported, a congressional probe is under way, legislation has been introduced and President Obama issued an executive order (seehere and here). In the latest effort to better understand the exact nature of the problem, IMS Health has examined some of the nuances and characteristics, and reports these findings....
The problem is actually highly concentrated in that 83 percent of the drugs for which shortages exist are generics, and 82 percent are injectables, according to IMS. On one hand, these represent a small part of the overall market, but involve critical drugs used to treat cancer, infections, cardiovascular disease, central nervous system conditions and pain. Oncology drugs comprise 16 percent of the meds in short supply, the market research firm finds, affecting nearly 550,000 patients annually. Anti-infectives are a close second at 15 percent. The shortages involve a large number of suppliers, but most of the meds are made by only or two companies.. More than 100 drugmakers supply 168 meds included on the shortages list maintained by the FDA and the American Society of Health-System Pharmacists, but 51 percent of the drugs have only one or two suppliers. And 13 drugmakers have stopped supplying meds on the shortages lists within the past two years, suggesting supplies of still more meds are likely since the slack would not be picked up by other drugmakers (here is the list).
Nine of the companies, or their affiliates have supplied 20 or more products, including Hospira, Teva, Boehringer Ingelheim and Fresenius Kabi, which supplied more than 50 products each. The Boehringer unit, known as Ben Venue Laboratories, blamed capacity constraints, but did not publicly acknowledge ongoing quality control problems that were documented by regulators (see this).
The total supply volume for many of meds in short supply has actually been stable or growing - the total monthly supply volume for all meds on the list has increased 4 percent over the past five years, IMS writes. And, for more than half of the listed drugs, total supply is relatively stable or has increased. At the same time, IMS finds that "significant volatility" exists among suppliers, and this is a new trend.
For instance, for 75 drugs, "supply volume has fallen substantially. A subset of products has experienced supply declines of more than 20 percent in recent months, compared with a three-year base period ending in 2009," IMS writes. "The per-capita supply of injectables has fallen more than 30 percent in 13 states, suggesting significant treatment protocol disruption for patients." Which states? Hawaii, Arizona, Arkansas, Ohio, Massachusetts, Delaware, West Virginia, Florida, Maryland, Nevada, New Jersey, Kentucky and South Carolina.
What to do? IMS suggests an early warning System for drug shortages that should include risk identification, demand forecasting, a volatility index and predictive modeling (you can read the full IMS report here). Separately, the American Medical Association panel of delegates is expected to vote today to require drugmakers to report shortages (see this).
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11 Comments
Drug shortages are mostly generic injectables? Interesting! Ironically, cuts in Medicare payments to doctors who administer outpatient chemotherapy drugs (mainly injectable drugs) actually led to an increase in treatment rates among Medicare recipients, according to a Harvard University study last year.
Under the 2005 Medicare Modernization Act, Medicare no longer automatically paid what physicians billed. Instead, Medicare calculated the average amount that physicians typically pay for each chemotherapy drug and reimbursed no more than 6 percent above this average cost. If you can't increase the margin, increase the turnover!
Physicians don't always respond to incentives the way most people expect, but in this case they do respond in a way that makes sense to economists. It seems logical on the one hand that when you pay less, you get less. However, in this case, since a high proportion of an oncologist's income depends on prescribing, paying less per drug results in more drugs.
However, the use of more costly chemotherapy drugs increased, while the use of less-expensive drugs declined, the researchers found. Pehaps OII can answer this?
Greg, my dad was a general surgeon and surgical oncologist. In his experience, the older oncology drugs, used in correct combination, were comparable to the newer targeted drugs, with acceptable toxicity. Among his favorites were cisplatin, doxorubicin, and 5FU. Sadly, these are three of the drugs on the FDA shortage list.
OII
So your dad was one of your mentors (surgical oncologist). Hope you have picked his brain enough times. I've picked enough mentors' brains as much as I could over the last 15 years (still do). I wholeheartedly agree that older oncology drugs, used in correct combination, are comparable to newer targeted drugs, particularly with acceptable toxicity.
Cisplatin, doxorubicin and 5FU, all injectables, administered in outpatient clinics, at an increased rate since the MMA. I betcha Xeloda (the pill version of 5FU) is not prescribed much in community-based or hospital-based infusion clinics as opposed to injecting 5FU.
Dr. Neil Love's Research To Practice found out that in first line chemotherapy of metastatic breast cancer, 84-88% of the academic center-based oncologists (who are motivated to keep off-protocol patients out of their chemotherapy infusion rooms to reserve these rooms for on-protocol patients) prescribed oral-dose capecitabine, while only 13% prescribed infusion drugs, and none of them prescribed the expensive, highly remunerative drug docetaxel.
In contrast, among the commuity-based oncologists, only 18% prescribed the non-remunerative oral-dose drug (capecitabine), while 75% prescribed remunerative infusion drugs, and about 40% prescribed the expensive, highly remunerative drug docetaxel.
Mmm, what are the ethics of generic companies rushing to get approvals for products the very second patents run out and lock in deals to see their copies - only to not be able to supply them.
In the meantime, patent-holders, with the prospect of their markets getting completely eaten alive, stop making the original product (or make less of it).
This a big problem with the current generics field. Generic companies can't supply everything.
I'm not a CMC guru. Maybe someone can help. We hear that one reason for the shortages realtes to manufacturing issues. Leaving aside market forces, don't parenterally administered drugs need to subscribe to a higher CMC standard, re. pyrogen testing, sterile container closure systems, etc? I'm as skeptical as the next person, but given the above, might not there be some validity to some of the clasims re manufacturing problems?
If most drugs are generics, it makes sense that most of the shortages are for generic drugs. If only having one manufacturer contributes to shortages, why shouldn't brand products be a problem too?
There are lots of reasons for shortages. Unless you adjust your stats for overall market share...they are meaningless.
Original industry insider: Along with manufacturing issues, some shortages are triggered by supply chain problems.
Given the imminent creation of an FDA framework for the approval of biosimilars and the fact that infectious disease was replaced by cancer as the number one cause of death in the world (i.e. USA is competing for medicine), it concerns me that injectable drug shortages might get worse before they get better.
WRT to oral drugs, there are a lot of drugs that will be losing patent. It would mae sense for a generic drug company to focus on new oral generic drugs as these are often more profitable. I worry that we are at the tipping point for shortages of oral generic drugs.
OII,
I work in CMC for injectables. The problem is with the higher standards enforced these days and low profit margins of generic injectables, there is very little incentive for pharmaceutical companies to take the risk and dedicating valuable resources to manufacture when the FDA is breathing down your neck.
Kevin - thank you for supporting my point that I have been making to those that rile against the "high cost of medicine."
If you want safe drugs, they will necessarily be more expensive.
I just can't understand why more companies don't want to enter this highly regulated, low-margin, manufacturing-challenged marketplace.
Salient, you've just described the status of the US chemical industry, so how do they make money? As Murray Hamilton told Dustin Hoffman in "The Graduate", in a word: Plastics. Why plastics, because they are made of petrochemicals. Anybody getting the hint as to one reason why oil prices are so high?