Tonight I had a text exchange that included a fair number of expletives between myself and a few colleagues. What could get a couple of pediatric oncologists angry like this? Drug shortages. Yes, every year we have drug shortages that affect our ability to treat our children in the way that they need and we’re getting fed up with it.
The number of drug shortages in the US has steadily been on the rise. In 2005, there were 60 drug shortages. In 2012 there were more than 300. In response to this growing public health crisis, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA) on July, 9, 2012. Among other things, Title X of FDASIA directs the Food and Drug Administration (FDA or the Agency) to establish a task force on drug shortages to develop and submit to Congress a Strategic Plan to enhance FDA’s response to preventing and mitigating drug shortages. This has been helpful in some areas but transparency is still lacking. There are no regulations in place to require how the pharmaceutical industry communicates information about what drugs are manufactured at which plants and where those plants are located. This leads to a reactive situation and downstream scrambling to cover for our patients.
The graph shows the number of new and ongoing shortages each year. The types of drugs that are in short supply are generally injectable ones, such as chemotherapy, IV antibiotics and even IV fluids. This year, because of a disruption to manufacturers in Puerto Rico due to Hurricane Maria, we have been dealing with a shortage of IV fluids and the sterile bags to put the medications in.
The reasons for shortages are multifaceted and include:
1. Production of drugs may be temporarily stopped due to quality problems with how the drugs are made.
2. Shortages of raw materials due to problems with quality of these ingredients or severe weather.
3. Companies may make business decisions to stop making a product. Less of the drug may be available after the merger of two companies that make the same product.
4. Changes in the amount of medications supplied to different hospital systems, community pharmacies, and chain drugstores.
#3 is why pediatric oncology is hit so hard. Most pediatric cancer drugs are old and are in generic form. When vincristine only sells for 8-15 dollars per vial and a new drug on the market under patent can sell for $10,000+ dollars…well, it’s pretty obvious that business choices come into play.
The problem is that behind those business decisions and drug shortages are actual PEOPLE. It is a young man who couldn’t enroll on a clinical trial this week because we were missing a standard drug that was part of the trial. It is a child who traveled around the world for the best care and I have to hand him bottles of water in the room and ask him to please drink because we can’t start IV fluids until much later because they are on ration. It is a young boy whose tumor is finally shrinking and now I don’t have one of the drugs that is working to give him any longer. It’s infuriating.
These are big issues with complicated solutions. If you are well connected, like to lobby, or write your congressmen and women here are some questions to consider (taken from ASCO advocacy site).
1. Should manufacturers be required to disclose to the medical community their manufacturing sites andthe products produced in those sites, in terms of volume and percentage of product line?
2. Should sole-source products be allowed to be produced in a single plant?
3. Should there be redundancy in production of critical products?
4. Should the FDA identify a list of “critical medications” that would require manufacturers to develop areasonable contingency plan in the event of a production interruption or shutdown?
5. What incentives could be developed for other manufacturers to increase production when drug shortages occur?
6. What can be done to determine the best locations of pharmaceutical plants in addition to ensuring that backup systems can quickly accommodate needs in the event of a disaster, given there are several types of natural disasters that can occur?
“The only thing necessary for the triumph of evil is for good men to do nothing” Edmund Burke
#morethanfour #ChildhoodCancer365
- ASHP Drug Shortage Resource Center
www.ashp.org/shortages
www.ashp.org > Resource Centers > Drug Shortages > Current Shortages
Provides information and shortages and the management of drugs in short supply - FDA Drug Shortages Page
www.fda.gov/Drugs/DrugSafety/DrugShortages
Lists current and resolved drug shortages, drugs to be discontinued, and policies & procedures.
