Dear Editor,

I was distressed to see the article "The Dilution Confusion: Easy Dosing for Botulinum Toxins" advocating the use of a decapper to remove the metal collar and rubber stopper on vials so there is no waste of product. This is putting profits ahead of patient safety.

This practice is contrary to basic infection control guidelines. Per the Association of Professionals in Infection Control (2016): "Never use a decapping device to remove the top from a vial (e.g., to pour medications). Draw solutions through the diaphragm with a sterile syringe and sterile transfer device or needle using aseptic technique."

The Association of Professionals in Infection Control (2016) states that practitioners should always follow the manufacturer's instructions for storage and use. In a discussion that I had with Ms. Janet Bospecter of the Medical Information Division of Allergan on April 15, 2016, the manufacturer never advocates removing the collar and rubber stopper, as it potentially compromises sterility and puts the patient at risk.

While we are on the topic of proper techniques for botulinum toxins, I understand that there are many practitioners who use the single-use vial for multiple patients. Per Allergan in its "Highlights of prescribing information":

2.2 Preparation and Dilution Technique

BOTOX Cosmetic is supplied in single-use 50 Units and 100 Units per vial. Prior to intramuscular injection, reconstitute each vacuum-dried vial of BOTOX Cosmetic with sterile, preservative-free 0.9% Sodium Chloride Injection USP. Draw up the proper amount of diluent in the appropriate size needle and syringe to obtain a reconstituted solution at a concentration of 4 Units/0.1 mL and a total treatment dose of 20 Units in 0.5 mL for glabellar lines and 24 Units in 0.6 mL for lateral canthal lines (see Table 1). Then slowly inject the diluent into the vial. Discard the vial if a vacuum does not pull the diluent into the vial. Gently mix BOTOX Cosmetic with the saline by rotating the vial. Record the date and time of reconstitution on the space on the label. BOTOX Cosmetic should be administered within 24 hours after reconstitution. During this time period, reconstituted BOTOX Cosmetic should be stored in a refrigerator (2[degrees] to 8[degrees]C). BOTOX Cosmetic vials are for single-use only. Discard any remaining solution.

Reconstituted BOTOX Cosmetic should be clear, colorless, and free of particulate matter. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration and whenever the solution and the container permit. Do not freeze reconstituted BOTOX Cosmetic.

2.3 Administration

Draw at least 0.5 mL (for glabellar lines) or 0.6 mL (for lateral canthal lines) of the properly reconstituted toxin into the sterile syringe, preferably a tuberculin syringe and expel any air bubbles in the syringe barrel. Remove the needle used to reconstitute the product and attach a 30-33 gauge needle. Confirm the patency of the needle."

Per the Centers for Disease Control and Prevention (n.d.):

A SINGLE-DOSE VIAL (SDV) is approved for use on a SINGLE patient for a SINGLE procedure or injection. SDVs typically lack an antimicrobial preservative. Do not save left over medication from these vials. Harmful bacteria can grow and infect a patient.

These unsafe practices that have become commonplace with regard to the preparation and administration of botulinum toxin solutions are a good example of the normalization of deviance. Per AORN Journal:

When a nurse or other health care provider knowingly disregards safety practices, there is the risk that this behavior will become accepted as part of the individual's routine practice (i.e., normalized deviance). (Waring, Harrison, & McDonald, 2007)

The normalization of deviance is insidious and can spread throughout a workplace as others observe the unsafe practice, believe it is acceptable, and adopt the practice themselves.... Normalization of deviance rarely affects just one person. If the person seen performing the deviant behavior is an authority figure, a role model, or someone who coworkers see as uncorrectable, the behavior the person demonstrates can go unchallenged and spread to others. Deviations may initially appear harmless or appear to pose only a small risk; but over time, practice compromises, however small, can lead to tragedy for a patient. One practitioner cutting corners can make a difference. (McNamara, 2011)

Rachelle Springer, MS, ARNP, CS, CPSN, LHCRM

Clinical Consultant

Office Surgery

RCS Consulting Group

Boca Raton, FL

[email protected]

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