Drug Shortages, Product Standardization Plague IV Drug Delivery

Ongoing threats to the safety of intravenous (IV) drug delivery include drug shortages and lack of IV product standardization, according to an expert panel.

The panel of health care providers developed recommendations after they received feedback from 30 health care industry leaders at the Third Consensus Conference on the Safety of Intravenous Drug Delivery Systems in November 2018.

The findings of the panel, who have experience in medication quality and safety, pharmacy and nursing operations, information technology, and/or sterile compounding, were published in the American Journal of Health-System Pharmacy.

The panel’s findings include:

1. The panel believes in the overall superiority of manufacturer ready-to-use products, and says they are the safest IV drug delivery systems, followed by outsourced, ready-to-use, pharmacy compounded, point-of-care activated, and nonpharmacy compounded at point of care.

2. Drug shortages and lack of standardization are the 2 most significant threats to IV drug safety. “The panel concluded that drug shortages in particular are not only a highly significant threat to patient safety, but they are also a threat to the consistent use of the safest IV drug delivery system,” the panel wrote.

Of all reported shortages through September 30, 2018, 56% involved injectable medications. “The rate of new shortages continues to increase and involves many essential medications (eg, bupivacaine, lidocaine, morphine, saline, and sterile water) that severely impact patient care as well as pharmacy operations,” the panel wrote. “The inability to acquire manufacturer ready-to-use products due to shortages may result in medication errors and patient harm, as health care institutions are required to use less-safe IV drug delivery systems.”

3. Variations in IV medication concentrations during transitions of care within the same institution or between different facilities can increase the likelihood of a medication error, leading the panel to identify lack of standardization as a major threat to safety.

In addition, a requirement to compound patient-specific preparations leading to the calculation of custom infusion rates may also lead to harm, according to the panel. “The lack of agreement regarding standard concentrations for widely used IV medications may result in health care institutions increasing the amount of pharmacy-compounded products and thereby increase quality and safety concerns.”

4. Manufacturer-prepared products are the safest IV drug delivery system, and manufacturer-prepared, ready-to-administer products are preferred for patient use whenever possible, the panel said. “Compounding sterile preparations is a high-risk practice, and incorporating established standards, such as USP chapter 797, is essential to ensure benefit while reducing risks to the patient,” the panel wrote. All non-pharmacy compounding should be restricted to only immediate-use, urgent situations.

5. Specialized education, training, certification, and competency with regard to compounding of sterile preparations should be required for pharmacists, pharmacy technicians, and other involved health care providers. In addition, the industry should utilize automation and technology that have been validated to improve the safety of CSPs.

6. A legislative and regulatory framework that supports and encourages IV medication safety in all settings (such as physician offices) should be developed. “The organizational costs of inaction, or of pursuing the minimum action necessary with regard to the safety of IV drug delivery, far exceed an institutional financial investment in the safest systems for the patient and staff,” the panel said.