The 4 most problematic drug shortages

June 12, 2015

Drug shortages are significant public health threats. They can delay, or even deny, critical care for patients. Here are the four drugs in shortage that are among the most problematic.

Drug shortages are a significant public health threat that can delay, and in some cases even deny, critical care for patients. 

A recent article in The Wall Street Journal featured a bladder cancer patient's inability to access BCG to treat her cancer due to a shortage of the drug. According to the University of Utah Drug Information Services, the number of drugs in short supply in the United States has risen 74% from 5 years ago to approximately 265. 

Related: Drug shortages mobile app launched by FDA

Dr BenjaminHere, Bona E. Benjamin, BS Pharm, director, Medication-Use Quality Improvement and coordinator, Drug Shortages Resources Center for Medication Safety and Quality, American Society of Health-System Pharmacists (ASHP), and the University of Utah Drug Information Service, helps identify the 4 drugs in short supply that are among the most problematic.

Additional information can be found at the ASHP’s drug shortages page and at FDA’s drug shortages page.

#1. Droperidol, Promethazine Injection, Prochlorperazine Edisylate Injection, and Ondansetron Injection

These drugs are the most common drugs used for treating nausea and vomiting.

Droperidol

Reason for droperidol shortage:

  • American Regent has droperidol injection on back order due to manufacturing delays.

  • Hospira has droperidol on back order due to shortage of raw material.

Estimated resupply dates:

  • American Regent and Hospira both have droperidol 2.5-mg/mL 2-mL vials on back order and the companies cannot estimate a release date.

For more on droperidol, see ASHP’s shortage bulletin.

Promethazine injection

Reason for shortage:

Estimated resupply dates:

  • Hospira has promethazine 25 mg/mL 1 mL Carpuject syringes on back order and the company cannot estimate a release date.

  • Teva has all promethazine injection presentations on back order and the company estimates a release date of July 2016.

  • West-Ward has promethazine 25-mg/mL 1-mL ampules on allocation. Promethazine 25-mg/mL 1-mL vials are available in both regular and short expiration dating (November 2015). Promethazine 50-mg/mL 1-mL ampules are on allocation. Promethazine 50-mg/mL 1-mL vials are available with short expiration dating (April 2016).

  • West-Ward has Phenergan 50-mg/mL 1-mL ampules available with short expiration dating (October 2015). Phenergan 50-mg/mL 1-mL vials are available with short expiration dating (April 2016). Phenergan 25-mg/mL 1-mL ampules in 25 count are on back order and the company cannot estimate a release date. Phenergan 25-mg/mL 1-mL vials are available on allocation.

  • X-Gen has promethazine 25-mg/mL 1-mL ampules on back order and the company cannot estimate a release date.

For more on promethazine injection see ASHP’s shortage bulletin.

Prochlorperazine Edisylate Injection

Prochlorperazine is a phenothiazine antiemetic used to control nausea and vomiting produced by a variety of causes. During this shortage use alternative antiemetics. Oral and rectal prochlorperazine products are effective, however these routes may not be practical for all patients.

Reason for shortage:

Alternative agent/management:

No single agent can be substituted for prochlorperazine injection. The choice of alternative agents must be patient-specific and based on the clinical situation.

Estimated resupply dates:

  • Heritage has prochlorperazine injection available.

For more on prochlorperazine injection, see ASHP’s shortage bulletin.

Ondansetron injection

Reasons for shortage:

  • AuroMedics did not provide a reason for the shortage.

  • Caraco temporarily discontinued ondansetron injection.

  • Ben Venue stopped production in its plant in Bedford, Ohio, and closed in July, 2014.

  • Fresenius Kabi has ondansetron injection on back order due to increased demand.

  • Heritage cannot provide a reason for the shortage.

  • Sagent has ondansetron on back order due to increased demand.

  • Teva re-launched ondansetron 20-mL injection in 2015.

  • West-Ward had ondansetron on back order due to increased demand.

  • Wockhardt has ondansetron injection on an FDA import alert.

  • All presentations of ondansetron 32-mg/50-mL premixed bags have been discontinued.

Estimated resupply dates:

  • AuroMedics has ondansetron 2-mg/mL 2-mL vials on intermittent back order with regular releases.

  • Fresenius Kabi has ondansetron 2-mg/mL 2-mL vials on back order and the company cannot estimate a release date.

  • GlaxoSmithKline has Zofran 2-mg/mL 20-mL vials on back order and the company estimates a release date of mid-June 2015. Zofran will be ordered from Novartis instead of GlaxoSmithKline as of June 1st, 2015.

  • Heritage has ondansetron 2-mL and 4-mL vials on allocation with full recovery estimated in August 2015.

  • Hospira has ondansetron 2-mg/mL 2-mL vials on allocation.

  • The Medicines Company has ondansetron 2-mg/mL 2-mL and 20-mL presentations on back order and the company cannot estimate a release date.

  • Sagent has ondansetron 2-mg/mL 2-mL vials on allocation.

  • West-Ward has ondansetron 2-mg/mL 20-mL vials (NDC 00143-9890-01) available with both regular and short expiration dating (October, November, or December 2015). The 20-mL vials (NDC 00641-6079-01) are also available with both regular and short expiration dating (February 2016). The 2-mL vials are on allocation.

For more on ondansetron injection, see ASHP’s shortage bulletin.

 

NEXT: Nitroglycerin injection shortages

 

#2. Nitroglycerin injection

Nitroglycerin is a vasodilating agent. Intravenous nitroglycerin is used in conditions such as cardiac arrest to increase flow of oxygenated blood through blood vessels.

“No one alternative drug is therapeutically equivalent to nitroglycerin,” according to Dr Benjamin.

Reasons for shortage:

  • American Regent has recently upgraded their manufacturing plant. Product will become available in stages as production resumes.

  • Hospira discontinued nitroglycerin injection.

  • Baxter had nitroglycerin premixes on shortage due to a raw material supply issue.

  • Arbor Pharmaceuticals, in cooperation with FDA, was importing glyceryl trinitrate (Nitronal) injection to the US market to help alleviate the shortage. This glyceryl trinitrate is manufactured in an FDA-approved facility in Germany by Pohl Boskamp. Glyceryl trinitrate is another name for nitroglycerin.

Alternative agent/management:

No single agent can be substituted for this drug. Alternatives will depend on the specific therapeutic indication and patient characteristics.

Estimated resupply date:

  • American Regent has nitroglycerin 5-mg/mL vials in limited supply. The company offers daily updates.

  • Baxter has all nitroglycerin premixed bottles on allocation.

For more, see ASHP’s shortage bulletin.

 

NEXT: Methylene blue injection and indigo carmine injection shortages

 

#3. Methylene blue injection and indigo carmine injection

These are 2 marker dyes commonly used in diagnostic procedures. The dye used depends on the type of procedure, as well as physician discretion, according to Dr Benjamin.

Reasons for shortage (methylene blue injection):

Alternative agent/management:

There’s no single dye that can replace methylene blue; consider reserving a supply of methylene blue for the treatment of methemoglobinemia. A recommended stocking level is five 10-mL vials to treat 1 patient.

Estimated resupply date:

  • Akorn has both methylene blue 1-mL and 10-mL vials on intermittent back order and is releasing it as soon as it becomes available. Resolution is expected in early July 2015.

  • American Regent has all methylene blue presentations on back order and it cannot estimate a release date.

For more on methylene blue injection, see ASHP’s shortage bulletin.

Indigo carmine is indigotindisulfonate sodium, a marker dye used during cystoscopy and ureteral catheterization.

Reasons for shortage (indigo carmine injection):

  • American Regent has this drug on back order because of manufacturing delays.

  • Akorn has discontinued production of indigo carmine due to raw material shortage.

Alternative agent/management:

There is no single dye that can replace indigo carmine.

Estimated resupply date:

American Regent has indigo carmine 8 mg/mL 5 mL ampules on back order and the company cannot estimate a release date.

For more on indigo carmine injection, see ASHP’s shortage bulletin.

 

NEXT: Vancomycin shortages

 

#4. Vancomycin

Vancomycin is an antibiotic used for serious infections and pretreatment of certain patients at risk for infection before surgery, according to Dr Benjamin. Vancomycin is active against gram-positive bacteria, including staphylococcal species, streptococcal species, and enterococcal species.

“It is usually reserved for certain organisms, patients allergic to other drugs, and patients requiring prophylaxis for certain surgical procedures,” she said.

Reasons for shortage:

  • Baxter is allocating vancomycin.

  • Sagent has vancomycin injection on allocation due to increased demand.

Alternative agent/management:

Institutions should not stockpile vancomycin injection and should adhere to the Centers for Disease Control and Prevention (CDC) recommendations for avoiding unnecessary vancomycin use and thus preventing the spread of vancomycin resistance.

Estimated resupply date:

  • Fresenius Kabi has vancomycin 5-g and 10-g bulk vials on intermittent back order and the company is releasing product as it becomes available. Vancomycin 500-mg and 1-g vials are on allocation.

  • Baxter and Hospira have all vancomycin presentations on allocation.

  • Mylan Institutional has vancomycin 500-mg vials and 10-g bulk vials on intermittent back order and the company is releasing product as it becomes available. Vancomycin 1-g and 5-g vials are available for drop shipment only.

  • Sagent has vancomycin 5-gram vials on allocation.

For more, see ASHP’s shortage bulletin.

FormularyWatch/Source: ASHP Drug Shortages Resource Center

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