Drug Shortages Harm Patients

By Paul Abramowitz posted 01-08-2018 13:45

  
ASHP and our colleagues at the University of Utah have been leaders in providing ASHP members, policymakers, and the entire healthcare community with timely information on drug shortages for nearly 15 years. We have also worked hand in hand with numerous stakeholders to find solutions to help minimize or prevent drug shortages. These efforts have included passing federal legislation and holding numerous multidisciplinary summits on drug shortages, with the most recent stakeholder summit taking place on November 6, 2017, at ASHP headquarters.

Today, although progress has been made, drug shortages are still significantly threatening the ability of ASHP members and their healthcare colleagues to provide care to patients. It is unacceptable in the United States that drug shortages can happen as frequently as they do — and certainly not acceptable for them to harm patients. Regardless, the problem persists and grows, with the most recent being the severe shortage of small-volume parenteral (SVP) solutions.

Soon after we became aware that an SVP shortage had emerged, ASHP and the University of Utah released a resource on the conservation and management of SVPs. This resource has proven useful to ASHP members and other providers, and its use has been encouraged by the FDA Commissioner.

We have also been working on a daily basis with the FDA, Congress, and numerous other concerned organizations to find solutions for all drug shortages and advocate for needed changes. Further, we are working to keep the entire shortage situation on the radar of the media. ASHP also immediately conducted a survey to better understand the magnitude of SVP and other shortages, and to use that survey data in our advocacy and media outreach on behalf of our members and their patients.

ASHP believes that it is time for Congress to get involved to stop this threat to safe and effective patient care. ASHP recently led the development of a congressional call to action with other key stakeholders. In that letter, ASHP and our partners asked Congress to examine the following questions to address the underlying causes of shortages:

  • Should manufacturers be required to disclose to the medical community their manufacturing sites and the products produced in those sites, in terms of volume and percentage of product line?
  • Should sole-source products be allowed to be produced in a single plant?
  • Should there be redundancy in production of critical products?
  • Should the FDA identify a list of “critical medications” that would require manufacturers to develop a reasonable contingency plan in the event of a production interruption or shutdown?
  • What incentives could be developed for other manufacturers to increase production when drug shortages occur?
  • 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?
We strongly believe that the current drug shortage situation is unacceptable and unsustainable. It threatens harm to patients, wastes valuable healthcare resources, causes great uncertainty, and disrupts the healthcare system. Congress should not wait to take action on drug shortages until the current crisis worsens even further. The time for leadership and action is now.

ASHP will continue to be the leader on this critical patient care and patient safety issue until we and our partners find solutions that ensure that no patient is ever affected as a result of a drug shortage. Please contact your member of Congress through ASHP’s call to action, and please continue to review ASHP’s website and other communications for updates. Also, please don’t hesitate to contact us if you have any questions or need assistance from our drug shortages staff team. ASHP is looking for both short-term relief to current shortages and long-term solutions. Therefore, fixing the drug shortage problem will remain a top priority for ASHP until meaningful and systemwide solutions are identified and implemented.

Thanks so much for being a member of ASHP, and for everything that you do for your patients.

Paul

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23 days ago

This is such a serious issue....I work in a Long Term Acute Care Facility. I watch my Pharmacist struggle with this problem daily. They have to make those tough calls on who should be allow the last few Morphine or Demerol, it's unfathomable. How can we call it comfort care when there is nothing comfortable about it. I have contacted the FDA myself (not that it will do any good) asking to please do something. This needs to stop.

01-09-2018 16:23

​Thank you Paul and ASHP for addressing drug shortages and especially efforts to bring others like the AHA and other health professions to the table and to take action. Keeping the issue in the public eye like Monday’s article on the front page of the Wall Street Journal, including perspectives provided by Erin Fox, is important. The big difference in what I see in the press vs. what Paul raises in his blog is the issue of patient harm. Most of what is in the press and what most health systems are permitted to say publically paints this issues as a logistical challenge that is an inconvenience and adding costs that hospitals are managing. And it continues to be conveyed as a hurricane related problem (mainly with SVPs) that will go away once manufacturing capacity is restored in Puerto Rico.  The bottom line message conveyed by health systems is that we have good people working hard to deal with the issue and the public need not be concerned about care that is being delivered. But are patient’s really being harmed? I suspect they are.

The last time ASHP and others got Congress’ attention to act on drug shortages is when parents of children with cancer, who could not access the chemo drug of choice to treat their kids, went public. Until Congress sees this as a public safety issue vs. a disaster recovery / business issue, I do not believe we will get their attention to act. I would encourage those who have patients who experienced harm due to IV or drug shortages to ask those patients as well to reach out to Congress putting a constituent’s face and story to this public health crisis. I would add this to ASHP’s call to action for our members.

01-09-2018 10:05

Thank you to Paul, and all of the staff at ASHP for their critical attention to this public health crisis. I encourage everyone to join in ASHP's Call to Action - this is for our patients.

01-08-2018 14:49

All US Corporations just got a big tax cut. What they should do with their additional earnings, is to invest in US-based, sterile, pharmaceutical manufacturing facilities. Unfortunately, in the absence of incentives to do this, they will instead just redistribute this new wealth to their stock holders and to their corporate executives in the form of additional compensation.

Left the way things are, pharmaceutical manufacturers will continue to find the cheapest way possible to manufacture generic pharmaceuticals. Often, that means outsourcing to foreign contractors who are under less scrutiny by the FDA. If the FDA made it more difficult for companies to use cheap contract manufacturers overseas, then this would remove this easy option by corporate pharmaceutical executives. There need to be incentives to force/encourage corporate America to do the right thing for the American public, not just the few stockholders.

Our lives depend on this...

01-08-2018 14:25

I agree with the ASHP Call to Action. Free enterprise alone has driven the pharmaceutical manufacturing business plans and production processes. Pharmaceutical manufacturer altruism has evaporated this millennium.  Organized and meaningful actions are required to reset our medication supply chain market for the care of patients.