July 25, 2012

CDC: Trained Pharmacists Must Be Involved in Dividing Single-Use Vials

Atlanta—In the wake of two outbreaks of invasive Staphylococcus aureus infection in 10 patients being treated for pain in outpatient clinics, the CDC is strongly urging providers faced with drug shortages to avoid using single-dose vials (SDVs) or single-use medications for more than one patient unless the formulation is prepared by a “high-quality” pharmacy.

In both cases, the clinics reported that they were unable to obtain smaller vial sizes needed by patients, either because of drug shortages or because the smaller size wasn’t being manufactured.

“These scenarios do not excuse unsafe practices,” Michael Bell, MD, associate director for infection control at CDC's Division of Healthcare Quality Promotion, writes in a blog. “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.” Bell also points out that some health care providers have been able to use alternative medications when the preferred agent is in short supply.

In the blog, Bell notes that the outbreaks were “completely preventable,” but that clinic staff members apparently were unaware that splitting the medication vials could put patients at risk of infection. They did try, however, using new needles and syringes. One of the clinics even prepared a “clean” medication preparation room.

Still, 10 patients who had received care at the clinics required hospitalization for severe infections—such as mediastinitis, bacterial meningitis, epidural abscess, septic arthritis, bursitis, and sepsis—caused by either Staphylococcus aureus or its drug-resistant form, MRSA.

“These outbreaks are a reminder of the serious consequences that can result when SDVs are used for more than one patient,” Bell emphasizes. “Clinician adherence to safe injection practices, particularly when appropriately sized SDVs are unavailable, is important to prevent infection transmission. If SDVs must be used for more than one patient, full adherence to U.S. Pharmacopeia standards is critical to minimize the risks of multipatient use.”

The most common side effects reported with Truvada included diarrhea, nausea, abdominal pain, headache, and weight loss. Overall, serious adverse events were uncommon.

Research is continuing, with Gilead agreeing as a condition of approval to collect viral isolates from those who acquire HIV while taking Truvada and to evaluate these isolates for the presence of resistance. Data on women who become pregnant while taking Truvada for PrEP also is being collected.

Overall drug adherence information gathered by Gilead will be provided to prescribers to help them identify patients who are unlikely to comply with the drug regimen.

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