Why Are Some Prescription Drugs So Hard to Get?
If you have some types of cancer and your treatment includes chemotherapy, there’s a good chance you’ll be prescribed the drug Doxil. If your doctor can get her hands on any, that is. Doxil is one of many crucial drugs that’s in seriously short supply.
Just take a look at some posts to a message board for cancer patients: “The doctor’s office called to say ‘no Doxil available anywhere’.” “I managed to get two rounds of Doxil in for my recurrence [of ovarian cancer] but it’s not looking likely for round three.” “It turned out the Doxil I was so afraid of was not available.” Those are just a few comments posted online at the Ovarian Cancer National Alliance’s site by women with ovarian cancer facing a shortage of the drug.
And they help to explain the elation in the cancer community earlier this week when the Food and Drug Administration (FDA) announced that it had expedited approval of a generic version of Doxil (doxorubicin hydrochloride liposome injection) to help fill this great need. Until the company making the generic version is able to ramp up its manufacturing, the FDA will continue to allow a version made outside the U.S. to be imported for use by patients. In addition to ovarian cancer, Doxil is also approved (and in short supply for) multiple myeloma and AIDS-related Kaposi’s sarcoma.
This new approval will enable thousands of cancer patients to get the much-needed drug.
Doxil is just one of many drugs for which there’s a shortfall in the U.S.; according to the New York Times, the shortage peaked in 2011 at 251 drugs. The current FDA list of “endangered drugs” still tops 100 and includes two versions of the painkiller morphine; the flu drug Tamiflu; and Propofol, an anesthetic linked to the death of singer Michael Jackson.
Many of the shortages are for injected drugs, and the FDA says the problem is often manufacturing difficulties, since those drugs must be made in sterile facilities that can be hard to maintain. Other reasons for the shortages include scarce raw ingredients and companies getting out of the drug business. Congress’ General Accounting Office is looking into what impact price has had on drug shortages.
The White House issued an executive order in 2011 that requires drug manufacturers to let the FDA know if supplies of a drug look to be dwindling and the agency has introduced some strategies to ease the shortages, including allowing more drug imports and speeding up some drug approvals that can be used in place of drugs that are hard to find.
The shortages have had some very serious patient consequences. A recent study in the New England Journal of Medicine links a relapse in cases of Hodgkin’s lymphoma, which typically affects teenagers, to a shortage of a critical drug to treat the cancer, forcing doctors to swap in a less effective medication.
And in a survey last year by the Institute for Safe Medication Practices, based in Horsham, Pennsylvania, hospital pharmacists said they knew of patients who’d suffered harm from shortages of drugs, including cancer medications, opioid pain relievers, and antibiotics. The consequences included illness lasting longer than expected or progressing to a more serious stage; temporary and permanent injuries, sometimes because hospital staff did not know how to administer the replacement drug correctly; and even death. One pharmacist told of a nurse traveling three hours after her shift was over to go to another state to get a drug in short supply, so that a child wouldn’t be delayed a second time the next day for a stem cell transplant to treat leukemia.
The FDA is seeing success from its efforts: Over 100 drugs came off the shortage list in the past year. Lisa Kubaska, Pharm.D., a spokesman for the agency, says that after the executive order on drug shortages was issued last year, the FDA sent letters asking drug manufacturers to notifying the agency if they anticipated a disruption in their supply and they saw a six-fold increase in the number of notifications from manufacturers. The FDA now gets daily calls and emails from manufacturers about potential problems. “This has enabled FDA to work closely with firms to try to prevent shortages before they actually occur,” says Kubaska.
Consumers can help too: The FDA says notification from a doctor or patient is sometimes their first indication that a drug is in short supply. If a drug you need is unavailable you or your doctor can let the FDA know at email@example.com.
Have you ever experienced a shortage of a drug you or someone you love really needed?