Reuse of Drug Vials May Lead to Infections: CDC

Patients across the United States may be at serious risk for getting hospital-acquired infections after healthcare clinics provide multiple patients with injections of medications from vials that are meant to be used on just one person, federal health officials report. 

In recent months, there have been at least two high-profile cases involving patients hospitalized with severe infections due to drug vial mis-use.

One of those cases surfaced in Arizona in April 2012, involving at least three patients diagnosed with MRSA infections after receiving outpatient treatment at a pain management clinic.

The other case surfaced in Delaware in March 2012, when at least 7 patients were hospitalized with evidence of septic arthritis and bursitis after receiving joint injections from the same outpatient clinic.

According to a report in the current issue of the U.S. Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report (MMWR), federal health officials suggest that in both cases, clinicians reported difficulty obtaining the medication type or vial size that best fit their procedural needs, resulting in attempts to reuse single use vials on multiple patients.

Since 2007, the year that injection safety was included as part of Standard Precautions, at least 20 infection outbreaks have been associated with the use of single-dose or single-use medications on more than one patient.

The CDC report emphasizes the importance of full adherence to U.S. Pharmacopeia standards for safe injection practices to prevent infection transmission and reduce the risks associated with multipatient use of single-dose vials. The CDC indicates that medications labeled as “single dose” or “single use” should only be used for one patient. This protects patients from life-threatening infections that may occur when medications get contaminated from multiple patient use.

Concerns have been raised about whether these guidelines and related policies contribute to drug shortages and increased medical costs for health care providers.

The number of drug shortages annually has tripled from 61 in 2005 to 178 in 2010, according to an FDA report issued last year. Of the 127 studied drug shortages in 2010-11, the report states, sterile injectables accounted for the majority (80%).  The major therapeutic classes of drugs in shortage included oncology drugs (28%), antibiotics (13%), and electrolyte/nutrition drugs (11%).

The report also sates the leading primary reasons for the shortages reported to FDA were problems at the manufacturing facility (43%), delays in manufacturing or shipping (15%), and active pharmaceutical ingredient shortages (10%).

Manufacturing quality problems that have resulted in shortages can be serious, including findings of glass shards, metal filings, and fungal or other contamination in products meant for injection into patients.