It seems that every time I turn around these days there is another drug shortage that threatens Patrick’s health. Today, I spent over an hour on the phone trying to figure out the best oral form of L-carnitine to give Patrick, who is showing carnitine deficiencies but can’t receive them in his TPN because of shortages. Sadder still is the fact that I did all that work for a nutrient that he most likely can’t absorb in oral form anyway.
This was the final push I needed. I’ve been working on a draft of a letter to my state senator inviting him to help sponsor legislation that would require drug companies to actually tell the FDA when they expect that they won’t be able to produce enough of a drug so that they can try to encourage others to boost production.
I will mail this letter to the Senate today:
Dear Senator Lee,
My name is Emily Hoopes and I am mother to Patrick, a 2 year old who is waiting for an intestinal transplant. Patrick was born with a rare birth defect that led to the loss of his entire small intestine, a condition commonly known as Short Bowel Syndrome. Without a small intestine, Patrick cannot absorb nutrients from the food he eats. He relies entirely on intravenous nutrition, supplements, and drugs in order to grow and stay healthy while he waits for transplant. For the past two years, Patrick has beaten the odds time and again, defying doctor’s expectations. He is a happy, healthy, and active toddler, as long as he has this intravenous help to maintain nutrition and hydration.
That is why I am writing. Recently, an alarming number of drug shortages have occurred across the country, many of which have had a direct impact in Patrick’s quality of care. I am writing to ask your help in addressing the patient harm that is caused by drug shortages. Specifically, I am asking you to cosponsor S. 296, a bill that would help address the issues leading to drug shortages.
We are facing a drug shortage crisis in this country. Currently the American Society of Health-System Pharmacists (ASHP) DrugShortageResourceCenter lists 150 drugs in short supply. These include life-saving drugs, drugs to relieve pain, drugs to treat serious infections, medications used to provide parenteral nutrition (intravenous nutrition like my son uses), chemotherapy medications, and more.
Where these drugs are unavailable, doctors have been forced to use alternatives that have safety concerns, higher risk of error, and increased healthcare costs. When an alternative is unavailable, patients have no choice but to go without and hope for the best.
Since the beginning of the year, my little boy has already been directly affected by these shortages several times. In just the past few months, he has gone without several essential drugs, including vitamins, calcium, carnitine, amino acids, erythromycin (an antibiotic and motility medication), and ethanol (used to prevent infection.) There are also national shortages of other nutrients such as trace elements, vitamins, and electrolytes. Because Patrick cannot absorb nutrients by oral intake, when intravenous forms aren’t available, he simply goes without. For him, this means malnutrition and risk of serious complications. If this weren’t enough cause for concern, shortages of antibiotics and ethanol put Patrick at greater risk for a life-threatening systemic infection. Put more simply, a shortage of even one of these drugs can mean the difference between life and death for my son. With them, he has a good chance of surviving until he can receive a transplant. Without them, his prognosis is poor.
My son is not the only one whom these drug shortages have hurt. I am the founder of the Short Gut Syndrome Families’ Support Group, a national support group for children and families affected by Short Bowel Syndrome. Several of our members have felt the impact of these shortages and their children have been put at risk as a result. Just within our local chapter and hospital, rates of infection have increased, as have the number of nutritional deficiencies. As parents, we are scared for our children.
S. 296 would help improve communication between the U.S. Food and Drug Administration (FDA) and drug manufacturers. The legislation enables the FDA to work with drug manufacturers to establish contingency plans for manufacturing interruptions such as raw material shortages, adjustments to production capabilities, and product discontinuations.
Although I typically am of the opinion that less government regulation yields better results, the growing number of drug shortages is evidence that more needs to be done. S. 296 gives the FDA the resources needed to improve this problem.
Thank you for reading my story. And thank you in advance for your consideration to cosponsor S.296. Please do not hesitate to contact me if you have any questions or would like more information. I look forward to working with you as we work to resolve this import public health and patient safety issue.
Sincerely,
Emily Hoopes
If you’d like to know more about the drug crisis, just google “drug shortages”.
Patrick Hoopes 