Jean, a nurse and grandmother from Broomfield, has been bravely fighting advanced ovarian cancer for the past few years.
Initial treatment pushed Jean’s cancer into remission, but an April visit to her doctor revealed the cancer had returned. To treat it, her doctor prescribed a potentially life-saving chemotherapy drug, which she received in her first two treatments. But when she went to receive her third treatment in August, she was told that she would be unable to receive her treatment because her drug was unavailable.
As Jean and her family continue to struggle with this frightening situation, I find it astonishing that in the most civilized nation in the world, a patient in the middle of cancer treatment may face death because her physicians suddenly cannot obtain the drug she needs to save her life.
Recently, I had the privilege of visiting Exempla Saint Joseph Hospital to speak with doctors, pharmacists and patients like Jean about this growing medical crisis.
As drug shortages continue to rise, doctors are often forced to choose between delaying treatment or leaving patients susceptible to increased risk of side effects of substitute drugs or potentially harmful drug interactions. Pharmacists are left in the dangerous position of deciding how to dole out the sharply limited supply of over 200 drugs in shortage this year alone. And, as I heard that morning at Saint Joseph, the reality for patients is nothing short of terrifying.
Shortages of common, life-saving drugs continue to rise to critical levels, more than tripling since 2005. A vast majority of the drugs in short supply are used in life-saving treatments, including cancer therapies, widely used anesthetics, and pain medications. In many instances, no safe alternatives to these drugs exist.
Unfortunately, there is no single reason why shortages of drugs continue to increase. The drugs in shortage tend to be long-standing in the marketplace, and have been used widely for many years. They also tend to be injectable and are available in generic form. They are often difficult to make and must be manufactured in sterile environments. The Food and Drug Administration also reports that in many instances, shortages are caused by impurities in the drugs, like floating metals in a vial arising from the manufacturing equipment itself.
While solving such a complex crisis will require action on many fronts, we do know there are effective ways to begin to prevent the effects of these shortages. Communication and collective action throughout the system can help doctors and pharmacists better prepare to treat patients. Already this year, the FDA has prevented 99 prescription drug shortages when manufacturers have voluntarily reported to the government that they are experiencing or predicting a shortage.
As an important first step to begin to tackle this crisis, I have introduced bipartisan legislation to provide an early warning system, enhancing communications among all relevant stakeholders when shortages occur. The bill requires manufacturers to notify the FDA of shortages — including discontinuances or production interruptions — promptly. Information on those shortages, including the expected duration, would then be posted on the FDA website and distributed to health care providers and organizations. This bill represents an immediate safeguard to help prevent sudden shortages of life-saving medications, and will help us move forward in tackling this critical issue.
The Preserving Access to Life-saving Medications Act has broad bipartisan support in the House of Representatives and the Senate. President Obama is backing the legislation, and has called on Congress to pass it.
Around the country, Americans are expressing their frustration with the partisan politics of Washington. But drug shortages affect Democrats and Republicans equally, and far too many patients have no time for politics when they confront the unimaginable situation of coping with a devastating illness, only to be hit with the heartbreaking news that the very life-saving drug they need, their doctor can no longer provide.
For Jean and the thousands of other Colorado families whose health is at risk, this early warning system is a first critical step towards addressing this crisis.
Democratic Rep. Diana DeGette represents Colorado’s 1st Congressional District.
