Authorities Warn Against Multi-dose Drug Vial Use In Wake Of Colonoscopy Clinic Hepatitis C Outbreaks

Authorities Warn Against Multi-dose Drug Vial Use In Wake Of Colonoscopy Clinic Hepatitis C Outbreaks

shutterstock_161808080Hepatitis C outbreaks at three Toronto, Canada, colonoscopy clinics were not made public until the Toronto Star newspaper broke the story. The authorities that investigate outbreaks and inspect clinics, Toronto Public Health and the College of Physicians and Surgeons of Ontario, respectively, do not make such outbreaks public, but when pressed by the Star’s Theresa Boyle, Toronto Public Health confirmed that 11 patients had been infected, and that tainted sedative injections were the “possible” cause in all cases — specifically the use of multi-dose vials, which are small glass or plastic drug bottles containing more than one dose of liquid medication or vaccine used in conjunction with needles and syringes. Such vials can become contaminated if the same syringe or needle is used for multiple patients.

Ms. Boyle reports that nine of the 11 infected patients have since developed chronic hepatitis C, which means the virus has remained in their bodies, putting them at risk of serious, long-term health issues, including often-fatal cirrhosis of the liver and liver cancer.

In a presentation entitled Infection Prevention and Control: Out-of-Hospital Premises (OHP) and Independent Health Facilities (IHF) delivered at the College of Physicians and Surgeons of Ontario (CPSO) Canada, Education Day April 7, 2014, presenting Infection Prevention and Control (IPAC) Physicians: Dr. Maureen Cividino, MD, FCFP, CCBOM, and Dr. Kevin Katz, MD, MSc, FRCPC, noted that outbreaks associated with use of multidose vials in outpatient settings are frequent and recurring. They advise that multidose vials should be avoided when possible, and when using them is unavoidable, clinicians should:
• Never re-enter a vial with a used needle/syringe.
• Access all vials using a new sterile syringe, needle/cannula for each access and adhere to aseptic technique.
• See the product leaflet for recommended duration of use after entry of multidose vial.
• Mark vial with the date it was first used, to facilitate discarding at the appropriate time.
• Discard opened multidose medication vials according to the manufacturer’s instructions or 28 days after opening, whichever is shorter.
• Use multidose medication vials for a single patient whenever possible.
• Never leave a needle in a multidose vial.
• Discard medication vials if sterility is questioned or compromised.

For self administration of injectables, single dose vials are preferred over multidose vials, and patients are advised:
• Do not reuse single dose vials. They should be entered once and then immediately discarded.
• Cleanse the access diaphragm of vials using friction and 70% alcohol. Allow to dry before inserting a needle into the vial.
• Always use a new sterile syringe and needle when entering a vial
• The leftover contents of single dose vials should never be combined or pooled.

Single-use Medical devices must only be used ONCE (emphasis theirs), and critical and semicritical medical equipment/devices labelled as single-use must not be reprocessed and re-used unless the reprocessing is done by a licensed reprocessor. Single-use medical equipment/devices are usually labelled by the manufacturer with this symbol:

The Centers for Disease Control and Prevention (CDC) says transmission of life-threatening bacterial infections can occur when health-care personnel do not adhere to these Standard Precautions and instead use medication in containers labeled as single-dose or single-use for more than one patient.

The CDC cites a 2012 report summarizing investigation of two invasive Staphylococcus aureus infection outbreaks in Arizona and Delaware confirmed in 10 patients being treated for pain in outpatient clinics. In each outbreak, the use of single-dose or single-use vials (SDVs) for more than one patient was associated with infection transmission. In both investigations, clinicians reported difficulty obtaining the medication type or vial size that best fit their procedural needs.

“These outbreaks are a reminder of the serious consequences that can result when SDVs are used for more than one patient,” say the CDC. “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.” They note that medications labeled as “single dose” or “single use” typically are preservative-free and should be dedicated for single-patient use to protect patients from infection risks.

The report says proper use of SDVs in clinical settings consists of 1) withdrawing contents into a new sterile syringe in an aseptic manner, 2) promptly using the contents for a single patient during a single procedure, and 3) disposing of the vial and any remaining contents.

To prevent unsafe practices and patient harm, CDC recently issued a communication clarifying recommended practices for safe use of SDVs. The safest option remains dedicating SDVs to individual patients. When individually packaged and appropriately sized SDVs are unavailable, qualified health-care personnel may repackage medication from a previously unopened SDV into multiple single-use vehicles (e.g., vials or syringes). However, this procedure should only be performed using a laminar-flow hood in accordance with standards in U.S. Pharmacopeia General Chapter 797 (Pharmaceutical Compounding — Sterile Preparations). Strict adherence to U.S. Pharmacopeia 797 standards is critical and might have helped prevent recent outbreaks associated with unsafe practices (6,7). These outbreaks could be avoided if smaller medication vial sizes that better fit procedural needs were manufactured.

More information about safe injection practices can be found at:
http://www.cdc.gov/injectionsafety/CDCsRole.html
and:
http://www.cdc.gov/injectionsafety/

A Guidance document on Infection Prevention and Control for Clinical Office Practice by the Ontario Provincial Infectious Diseases Advisory Committee (PIDAC) can be accessed here:
http://www.publichealthontario.ca/en/eRepository/IPAC_Clinical_Office_Practice_2013.pdf

Sources:
Centers for Disease Control and Prevention
Public Health Ontario
The Toronto Star

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