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Alert: Concentrated Electrolyte Products During Drug Shortages

Example from CHPSO database: Due to a shortage of the premixed electrolyte solution bags used in the NICU, pharmacy had a process to compound the product if needed. The process, including the compounding recipe and labels were adopted from a sister facility. While compounding magnesium sulfate, a pharmacist discovered that the concentration in the vials at the sister facility was different than the concentration typically available at this facility.. This led to the compounding of a bag containing a total of 4.7 mEq magnesium sulfate instead of 0.75 mEq. Once the discrepancy was discovered, the labels and recipe were immediately corrected. The problem was caught after one bag had been compounded and given to a patient. The patient received  1.5 mEq/kg magnesium sulfate, a dose which is at least three times the usual dosing range of 0.3-0.5 mEq/kg. A magnesium level was checked upon discovery of the issue. Fortunately, the patient, who previously had hypomagnesemia, had a low-normal level after receiving the incorrectly compounded solution.

The National Alert Network (NAN), a coalition of the National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) members, recently issued an alert on safe handling of concentrated electrolyte products from outsourcing facilities during critical drug shortages.

Outsourcing pharmacies do not necessarily adhere to the labeling requirements commercial manufacturers must follow and the labeling and packaging differences may promote error. In the above case, similar vials ended up having significantly different quantities of a concentrated electrolyte.

CHPSO recommends review of the NAN alert and its recommendations for risk mitigation. The first two recommendations, in particular, should be highlighted:

  1. “Whenever possible, only use commercial FDA-approved products or, when necessary, products from outsourcing facilities that follow USP <7> labeling standards.
  2. “Anticipate unexpected differences in the labeling and packaging of products from outsourcing facilities…”

Steps to consider include restricting to pharmacy use only dangerous drugs (such as concentrated electrolytes) that do not conform to standard safety labeling, removing them from the wards.