Drug Supplies are Becoming Critical
One of the important stories in health care this past year has been the growing shortages of critical drugs. But the problem is getting worse not better.
It is now being reported that Methotrexate is in such short supply that the country may exhaust its stores by the end of February. This is especially true of the preservative free Methotrexate whose manufacturer, Ben Venue Laboratories, suspended production in November, 2011 because of “significant manufacturing and quality issues". This means thousands of patients and many children with acute lymphoblastic leukemia are at great risk of having their treatment suspended or not started.
Methotrexate is not the only cancer drug in short supply or the only critical drug with widespread shortages. In 2011 there were 230 drugs in short supply and at this point there are 180 critical treatment dugs in short supply. Many of these drugs are chemotherapy treatment medications. A survey of 200 board certified Oncologists by a for-profit research firm was released this week. Fifty percent of the respondents indicated that they expected to see hastened cancer deaths in 2012 due to the shortage and 48 percent said they saw tumor reoccurrences in 2011 due to the shortages of cancer treating drugs.
Also critical shortages are seen in attention deficit /hyperactivity disorder (ADHD) medications with Adderall and Ritalin in both brand and generic forms being in very short supply. In some parts of the United States only brand names are available and thus patients must pay $20 to $50 more in co-pays to obtain the medication. The FDA has labeled the ADHD drug shortage as a "situation out of control". The manufacturers blame the DEA for too low of quotas to meet demand and the DEA says plenty of supplies exist to fill the quotas and manufacturing process are the problem. Hospitals are especially seeing severe shortages of electrolytes, parenteral nutrition products for hyper alimentation, opioids like fentanyl for pain control after surgery and significant antibiotics. In fact commonly used drugs like tetracycline and erythromycin are in short supply.
In order to obtain these medication hospital are having to use the *gray" market where costs could escalate to 10 to 50 times as much to obtain the medication.
What causes the shortages-- It's a very complex situation-- in many cases its economics where brand protection is lost and generics are not as profitable so manufacturers close down lines or facilities. In the ADHD situation part of it is balancing controlled substances against increasing demand. The number of children being treated for ADHD has gone from 7.8% of all children in 2003 to 9.5% in 2007. The new guidelines have created the expanded treatment.
Physicians will have to work with their patient and pharmacies in any of these critical areas where drug shortages appear. The President has ordered the FDA to take a more active role in not only monitoring this problem but intervening when possible. When and if the drug shortage problem is solved the cost of medications for critical drugs will very likely be significantly higher.