Craig Klugman, Ph.D.
There is a silent crisis in medical care that has received little press and little discussion, and yet will affect every patient who requires hospitalization or medication. America is dealing with an enormous drug shortage that is forcing hospitals and doctors to make substitute prescriptions and in some cases to postpone elective treatments.
The shortage is not for expensive new drugs, but rather for generics and regular everyday chemicals that are necessary for the care of many types of patients. This list includes antibiotics, calcium, phosphate, potassium, zinc, salt, bicarbonate, alcohol, dextrose (sugar), lipids (fats) for artificial nutrition, pain relievers like morphine, as well as many drugs used in anesthesia, cardiac and neonatal medicine. Sometimes the problem is lack of an item altogether and sometimes it is a lack of a certain package size.
The cause of this shortage is multifactorial and complex. For some generic medications there may be few manufacturers and if one of them goes out of business or has a production problem, then a shortage of that drug can occur. Such generics have low profit margins and thus there is a low incentive to produce more or for new companies to being making them. For other items, the problem isn’t manufacturing the product but rather packaging. As it turns out, there are very few manufacturers of sterile glass vials into which most doses of medication are packaged and then used. Plastic vials may sound like an alternative, but they are not approved for use. Another cause is lack of the elements used to make the medications whether because they are hard to find (mine or create) or the source is a war torn region with inconsistent supply lines.
One might assume that hospitals and pharmacies have stockpiles of these medications that can be available when needed. And that would be wrong thinking because it turns out not to be good business. Most hospitals and pharmacies use “just in time ordering” meaning that they keep a limited supply on hand and order when it is needed. They may only have 10 days worth of any particular medication on hand at any given time, even when supplies are good. The reason is financial. For a drug to be on the shelf, a company had to spend money to purchase it and is spending more money to store it. After all, companies only receive payment when the drug is purchased. By limiting stock, hospitals and pharmacies spend less of their money out-of-pocket and can put reserves to work in an investment portfolio.
Even when manufacturers have supplies, the current shortage means that they restrict how much any one entity can purchase. How do they decide who gets the limited supply available? From my brief conversations, many companies distribute proportional to the amount of business they get from a company. Thus, if a hospital normally is 10 percent of a manufacturer’s business, then that hospital will be allocated 10 percent of the available supply. The hospital may have ordered 50 units, but if the manufacturer only produces 100 units, then the hospital gets 10 units.
Another layer to this situation is the appearance of grey market distributors. These are companies that call manufacturers, hospitals, and pharmacies and buy whatever stock they might find, usually when those entities have a surplus (remember just-in-time ordering and not keeping too much stock on hand). Then when that drug is in short supply, the distributor can turn around and sell the drug for 3 or 4 times the retail price. They buy drug on speculation that the price may raise and supplies may shrink. Of course by cornering market they are in effect causing some of the shortage.
Some institutions are turning toward compounding pharmacies that can get raw supplies and produce small batches or certain compounds or can take large batches of a drug and repackage it into smaller doses. Recently the FDA has cracked down on such pharmacies citing them for lacking sterile conditions and not meeting federal standards. Thus even these drugs are in short supply. Some hospitals have discussed starting their own sterile compounding programs but there is a large financial investment in equipment, space, personnel and certification.
This perfect storm means that a patient in the hospital who needs calcium chloride at say 10% solution may not be able to get it. Hospitals and pharmacies are left making tough choices. Some are recommending substitutions for their physicians; taking large containers and drawing up the drug into needles for dosing (rather than from sterile, sealed vials of smaller amounts). Others are trying small-dose, non-sterile compounding. And many are forced to ration. Some hospitals are calling off elective procedures and surgeries that are likely to require the use of these limited drugs, saving the supply for emergency cases and current patients. Another tool is having hospital units that tend to use a drug in high quantities (cardiology and neonatology use a lot of drugs in common such as calcium) sit down and discuss how they will use what drugs are on hand—for heart patients or for neonates who need calcium to build bone. One hospital I spoke with has even discussed giving patients a list of drugs they will need during their stay and encouraging them to procure them elsewhere and “bring their own.” This is a common practice in the third world where families often provide drugs, food and even nursing for patients.
We need to work to increase knowledge and awareness of the drug shortage today because it is already affecting the choices physicians make and the care that patients can receive. Some of the solutions can come from policy such as outlawing price gouging and stockpiling as well as providing incentives to manufacturers. Other solutions are related to changing financial practices that limit hospitals and pharmacies to small stocks. And even other solutions can be found in developing transparent practices in hospitals for how they ration drugs. Some hospitals are creating drug shortage committees to make decisions. Such committees need to include the ethics committee or service, pharmacy services, community members and representatives of all disciplines. Rationing policies also need to be regional in scope rather than individual. If every hospital has its own policy, then patients will simply shop from hospital to hospital to see who will give them what they need. Coordination of care and of drug availability needs to occur across hospital systems, planning that is similar to that of disasters.
This all starts with educating ourselves. The FDA keeps a list of current drug shortages ( http://www.fda.gov/drugs/drugsafety/drugshortages/ucm050792.htm ). And then we need to educate our friends and our communities.