In what is getting to be a familiar, tragic refrain, the improper use of single-dose vials has resulted in pain clinic patients in Arizona and Delaware acquiring serious bacterial infections that were “completely preventable,” the Centers for Disease Control and Prevention reports.
“Ultimately, ten patients in the two clinics were hospitalized for treatment of mediastinitis, bacterial meningitis, epidural abscess, septic arthritis, bursitis, and sepsis – all severe infections caused by either Staphylococcus aureus or its drug-resistant form MRSA,” Michael Bell, MD, an epidemiologist in the CDC’s Division of Healthcare Quality Promotion, reported in blog post .
The CDC details on the Arizona outbreak included the following key points:
- On April 8, 2012, the Arizona Department of Health Services was notified of a patient with acute mediastinitis with blood and pleural fluid cultures positive for MRSA. The report indicated this patient and two other patients with culture-confirmed invasive MRSA infections had undergone procedures recently at an outpatient pain management clinic.
- Investigations by the county and state health departments confirmed that the three MRSA-infected patients received pain injections on the same day, along with 25 other patients. Two MRSA-infected patients received epidural steroid injections, and one received a stellate ganglion block. Ten persons, including the MRSA-infected patients, received contrast injections for radiologic imaging to guide medication needle placement.
- Each morning, clinic staff members typically prepared contrast medium in the patient procedure room, before the arrival of patients; two new syringes were used to withdraw 5 mL each from a 10 mL SDV of contrast medium (300 mgl/mL) and a 10 mL SDV of saline solution. The contents from each syringe then were transferred to the alternate vial, resulting in two 10 mL vials of diluted contrast solution, one for use in the morning and one reserved for the afternoon. Among patients receiving contrast on the day of the outbreak, six received injections from the morning vial and four from the afternoon vial. All of the patients with MRSA infections received diluted contrast from the afternoon vial.
- The three patients with MRSA infections went to a local hospital 4–8 days after their outpatient pain remediation procedures. They required inpatient care for severe infections, including acute mediastinitis, bacterial meningitis, epidural abscess, and sepsis. Hospitalization ranged from 9 to 41 days, with additional long-term acute care required for one patient. The fourth recipient of diluted contrast from the afternoon vial was found deceased at home, 6 days after treatment at the clinic. The cause of death was reported as multiple-drug overdose; however, invasive MRSA infection could not be ruled out,
“These breaches resulted in life-threatening – yet completely preventable – infections in a number of patients receiving injections for pain relief,” Bell noted. “In both outbreaks, healthcare providers were splitting single-dose/single-use medication vials meant for one patient into new doses for multiple patients. There was a lack of awareness that this practice puts patients at risk of infection. Because injections were prepared with new needles and syringes and, in one of the clinics, in a separate “clean” medication preparation room, providers thought they were being safe. However, these preservative-free medications are not safe for multi-patient use.”
In both of the outbreaks, providers reported having difficulty obtaining smaller vial sizes that better matched patient treatment needs, either because of a drug shortage or because the smaller vial size isn’t manufactured, Bell notes.
“These scenarios do not excuse unsafe practices,” he says. “However, providers do have options. High-quality pharmacies that adhere to standards in United States Pharmacopeia General Chapter <797> can be used to more safely split doses from SDVs to increase availability, prevent waste, and minimize risk to patients. In addition, some providers are using appropriate alternate medications in times of shortage. “