Skip to content
  • About
  • Contact
  • Contribute
  • Book
  • Careers
  • Podcast
  • Recommended
  • Speaking
  • All
  • Physician
  • Practice
  • Policy
  • Finance
  • Conditions
  • .edu
  • Patient
  • Meds
  • Tech
  • Social
  • Video
    • All
    • Physician
    • Practice
    • Policy
    • Finance
    • Conditions
    • .edu
    • Patient
    • Meds
    • Tech
    • Social
    • Video
    • About
    • Contact
    • Contribute
    • Book
    • Careers
    • Podcast
    • Recommended
    • Speaking

Why the drug shortage is leading to desperate measures in hospitals

Al Patterson, PharmD
Meds
August 15, 2012
Share
Tweet
Share

More than 80 percent of the United States supply of heparin, a commonly used blood thinner, originates from pigs reared in farm co-ops in China. Farmers scrape mucus from the intestines and send it to central processing facilities, where heparin is extracted and purified before being sold to U.S. pharmaceutical companies.

But in 2007, blue-ear pig disease, causing a respiratory syndrome, became endemic in Asia—leading to a shortage of pigs and a shortage of heparin. In order to preserve their market share, producers began creating fraudulent substitutes, including one that behaved chemically like heparin, but was actually a manmade compound known as oversulfated chondroitin sulfate (OSCS) derived from pig, sheep or cow cartilage.

In late 2007 and early 2008, dialysis clinics in the U.S. began reporting cases of anaphylaxis – severe allergic reactions – that were eventually traced to tainted heparin from Baxter Healthcare Corporation. The problem spread beyond dialysis clinics, and Baxter recalled all their heparin lots in mid 2008. The highly allergenic, OSCS-tainted heparin caused at least 175 deaths worldwide.

That was the start of a drug shortage problem that extends far beyond heparin and is getting progressively worse, threatening the vulnerable children we treat. As a hospital pharmacy director, I’ve often dealt with drug shortages, but nothing like what we’re experiencing now.

In the wake of the heparin situation and others, the FDA dramatically ramped up its regulatory actions and inspections, shutting down many pharmaceutical manufacturers. Others abandoned the market on their own, finding the profit margins too low.

The remaining pharmaceutical vendors haven’t been able to pick up the slack. The number of drugs in short supply has tripled since 2006—it’s now hovering at around 265—and hasn’t crested yet.

To make things worse, wholesalers accelerated the practice of taking drugs out of normal distribution channels, selling them to secondary wholesalers, hoarding them and trying to sell them at inflated prices on the “grey market.”

We’re concerned. Methotrexate, which we use to treat acute lymphoblastic leukemia, the most common childhood cancer, is now in critical shortage. At one point, we could not obtain it—leaving us at the brink of being unable to provide a standard of care established by Sidney Farber’s work here 60 years ago.

Intravenous medications, especially generics, are especially hard-hit. Over the past year, we’ve had to scramble to provide essential IV nutrition for our premature infants, as every component of total parenteral nutrition (TPN) has been in short supply.


Here’s another example: When babies are born with a heart problem called patent ductus arteriosus—a blood vessel that fails to close at birth—we typically close the vessel by giving IV injections of indomethacin. A shortage of this medication has threatened to force these vulnerable infants to undergo surgery instead.

There are work-arounds and substitutions for some drug shortages, but other times, frankly, we have to resort to hoarding and rationing to protect our patients. We recently learned that chloral hydrate, used for sedation, is going to be discontinued. We bought forward more than a year’s supply to sustain us until we figure out another solution.

Work-arounds can be problematic, especially in critical care settings. Due to possible contamination and recalls, the anesthetic propofol has been in short supply, forcing our intensive care units to use earlier-generation anesthetics that cause nausea and vomiting and take longer to wear off. Even more alarming are the shortages of epinephrine and atropine, essential resuscitation medications that lack any real substitutes.

While the FDA has a small staff devoted to alleviating drug shortages, it has no authority to compel a company to manufacture a drug. It generally won’t allow importation from Europe, which is not experiencing shortages to the extent we are, unless the FDA inspects the facility.

Since an Executive Order issued last fall by President Obama, the FDA is now allowing some importations, like thiotepa from Italy, which we use to treat the pediatric brain tumor medulloblastoma (to the tune of $17,000 a vial). Late last month, the FDA even overrode a drug company patent and allowed a generic version of the ADHD drug Adderall to be marketed.

ADVERTISEMENT

On July 9, President Obama signed the Food and Drug Administration Safety and Innovation Act into law. Among its provisions is a requirement that manufacturers of certain drugs notify the FDA when they foresee a possible shortage. It also provides for expedited FDA review of proposed manufacturing changes for these drugs. Finally, it clarifies the rules around hospitals’ repackaging of drugs into smaller amounts, a provision especially helpful for pediatrics.

These are small steps, not a comprehensive solution to drug shortages. We will continue to work with the Children’s Hospital Association and others on further legislative strategies to solve this pressing issue.

Has the FDA gone overboard in regulating, as the House Committee on Oversight and Government Reform charged in June? It probably has. But in a drug industry that’s now become global, quality issues are a real concern. Eighty percent of active pharmaceutical ingredients come from the Pacific Rim, where we have no direct control. The tainted baby formula scandal was a dire warning of what can happen when there aren’t tight standards.

Drug shortages (and related price gouging) will likely get worse before they get better.  Until then, Boston Children’s and other hospitals will continue to beg, borrow and steal every way we can. If push comes to shove, we will formulate some drugs ourselves. In the meantime, we will build the most resilient safety net possible.

Al Patterson is Director of Pharmacy, Boston Children’s Hospital.  He blogs at Vector, the Boston Children’s Hospital science and clinical innovation blog.

Prev

AMA works to reduce administrative burden for physicians

August 15, 2012 Kevin 2
…
Next

Doctors who prescribe too many antibiotics: It's not that simple

August 15, 2012 Kevin 3
…

Tagged as: Cardiology, Hospital-Based Medicine, Medications, Pediatrics

Post navigation

< Previous Post
AMA works to reduce administrative burden for physicians
Next Post >
Doctors who prescribe too many antibiotics: It's not that simple

ADVERTISEMENT

More in Meds

  • Every medication error is a system failure, not a personal flaw

    Muhammad Abdullah Khan
  • Why kratom addiction is the next public health crisis

    Muhamad Aly Rifai, MD
  • FDA delays could end vital treatment for rare disease patients

    GJ van Londen, MD
  • Pharmacists are key to expanding Medicaid access to digital therapeutics

    Amanda Matter
  • How medicine repurposing enables value-based pain management and insomnia therapy

    Olumuyiwa Bamgbade, MD
  • Forced voicemail and diagnosis codes are endangering patient access to medications

    Arthur Lazarus, MD, MBA
  • Most Popular

  • Past Week

    • Why palliative care is more than just end-of-life support

      Dr. Vishal Parackal | Conditions
    • When life makes you depend on Depends

      Francisco M. Torres, MD | Physician
    • Guilty until proven innocent? My experience with a state medical board.

      Jeffrey Hatef, Jr., MD | Physician
    • Why medical notes have become billing scripts instead of patient stories

      Sriman Swarup, MD, MBA | Tech
    • How denial of hypertension endangers lives and what doctors can do

      Dr. Aminat O. Akintola | Conditions
    • A powerful story of addiction, strength, and redemption

      Ryan McCarthy, MD | Physician
  • Past 6 Months

    • Why transgender health care needs urgent reform and inclusive practices

      Angela Rodriguez, MD | Conditions
    • COVID-19 was real: a doctor’s frontline account

      Randall S. Fong, MD | Conditions
    • Why primary care doctors are drowning in debt despite saving lives

      John Wei, MD | Physician
    • New student loan caps could shut low-income students out of medicine

      Tom Phan, MD | Physician
    • Confessions of a lipidologist in recovery: the infection we’ve ignored for 40 years

      Larry Kaskel, MD | Conditions
    • mRNA post vaccination syndrome: Is it real?

      Harry Oken, MD | Conditions
  • Recent Posts

    • Imagining a career path beyond medicine and its impact

      Hunter Delmoe | Education
    • What is professional identity formation in medicine?

      Adrian Reynolds, PhD | Education
    • A step‑by‑step guide to crafting meaningful research questions

      Julian Gendreau, MD | Physician
    • When recurrent UTIs might actually be bladder cancer

      Fara Bellows, MD | Conditions
    • How restrictive opioid policies worsen the crisis

      Kayvan Haddadan, MD | Physician
    • Why doctors should rethink investing compared to the average U.S. investor [PODCAST]

      The Podcast by KevinMD | Podcast

Subscribe to KevinMD and never miss a story!

Get free updates delivered free to your inbox.


Find jobs at
Careers by KevinMD.com

Search thousands of physician, PA, NP, and CRNA jobs now.

Learn more

View 2 Comments >

Founded in 2004 by Kevin Pho, MD, KevinMD.com is the web’s leading platform where physicians, advanced practitioners, nurses, medical students, and patients share their insight and tell their stories.

Social

  • Like on Facebook
  • Follow on Twitter
  • Connect on Linkedin
  • Subscribe on Youtube
  • Instagram

ADVERTISEMENT

ADVERTISEMENT

  • Most Popular

  • Past Week

    • Why palliative care is more than just end-of-life support

      Dr. Vishal Parackal | Conditions
    • When life makes you depend on Depends

      Francisco M. Torres, MD | Physician
    • Guilty until proven innocent? My experience with a state medical board.

      Jeffrey Hatef, Jr., MD | Physician
    • Why medical notes have become billing scripts instead of patient stories

      Sriman Swarup, MD, MBA | Tech
    • How denial of hypertension endangers lives and what doctors can do

      Dr. Aminat O. Akintola | Conditions
    • A powerful story of addiction, strength, and redemption

      Ryan McCarthy, MD | Physician
  • Past 6 Months

    • Why transgender health care needs urgent reform and inclusive practices

      Angela Rodriguez, MD | Conditions
    • COVID-19 was real: a doctor’s frontline account

      Randall S. Fong, MD | Conditions
    • Why primary care doctors are drowning in debt despite saving lives

      John Wei, MD | Physician
    • New student loan caps could shut low-income students out of medicine

      Tom Phan, MD | Physician
    • Confessions of a lipidologist in recovery: the infection we’ve ignored for 40 years

      Larry Kaskel, MD | Conditions
    • mRNA post vaccination syndrome: Is it real?

      Harry Oken, MD | Conditions
  • Recent Posts

    • Imagining a career path beyond medicine and its impact

      Hunter Delmoe | Education
    • What is professional identity formation in medicine?

      Adrian Reynolds, PhD | Education
    • A step‑by‑step guide to crafting meaningful research questions

      Julian Gendreau, MD | Physician
    • When recurrent UTIs might actually be bladder cancer

      Fara Bellows, MD | Conditions
    • How restrictive opioid policies worsen the crisis

      Kayvan Haddadan, MD | Physician
    • Why doctors should rethink investing compared to the average U.S. investor [PODCAST]

      The Podcast by KevinMD | Podcast

MedPage Today Professional

An Everyday Health Property Medpage Today
  • Terms of Use | Disclaimer
  • Privacy Policy
  • DMCA Policy
All Content © KevinMD, LLC
Site by Outthink Group

Why the drug shortage is leading to desperate measures in hospitals
2 comments

Comments are moderated before they are published. Please read the comment policy.

Loading Comments...