Currently, a staple medicine, sodium bicarbonate solution, has come in short supply, precipitated by recalls, manufacturer delays, and increased demand.
Sodium bicarbonate is primarily used to rebalance the pH of patients whose blood has become too acidic. According to a recent article, “A Vital Drug Runs Low, Though its Base Ingredient is in Many Kitchens,” in The New York Times, sodium bicarbonate “is found on emergency crash carts and is used in open-heart surgery and as an antidote to certain poisons. Patients whose organs are failing are given the drug, and it is used in some types of chemotherapy.”
As it stands, there are only three manufacturers of sodium bicarbonate solution—one of which has recently begun making the product in response to the shortage.
The primary manufacturer, Pfizer, attributes the shortage to a delay in materials from third party glass supplier for its syringes as well as other unspecified delays. Compounding the problem, there was a separate recall due to some sodium bicarbonate solutions not being sterile.
There are other ways to manage the disbursement and use of sodium bicarbonate. On August 17th, 2017 The American Society of Health-System Pharmacists offered the following list of “Alternate Agents & Management”:
- Conserve sodium bicarbonate for critical uses. Avoid using product for non-essential purposes such as buffering lidocaine during this shortage. The Society of Critical Care Medicine has recommendations for conserving sodium bicarbonate.
- Evaluate vial use and consider methods to conserve supplies such as drawing up doses from vials rather than wasting unused product. Review storage locations such as crash carts and reduce inventory where possible.
- If purchasing premade Continuous Renal Replacement Therapy solutions, consider those with higher sodium bicarbonate concentrations.
- Sodium acetate injection can be an appropriate substitute for toxicology emergencies.
- Prepare oral solutions of omeprazole or lansoprazole using a sodium bicarbonate solution prepared from baking soda (1 teaspoon baking soda dissolved in 240mL water).
- Oral sodium bicarbonate 650-mg tablets may be an appropriate alternative for urine alkanization in patients receiving high-dose methotrexate.
Low-cost, generic drugs seem to be more susceptible to drug shortages, which is confirmed by a 2016 report from the U.S. Government Accountability Organization. There are at least two reasons this might be the case.
First, the products are manufactured on lines shared by dozens of other products, so, if there is a problem with the manufacturing line, a large number of products can be impacted.
Second, and perhaps more troubling, is that the margins on low-cost generic drugs are slim, so manufacturers have less financial incentive to stay on top of quality assurance measures in the same way they would for high-priced brand-name drugs.
However, there is reason for hope. In 2011, the FDA tracked 257 new shortages, an all time high according to The New York Times’ article, but that number fell to 23 in 2016. Healthcare professionals would be relieved if that trends continue, but it is nonetheless important to understand how drug shortages can be addressed at the hospital level and the limitations of what can be done.