ISMP releases new medication safety best practices document

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One response to “ISMP releases new medication safety best practices document”

1. August 15, 2016

   Ray Vrabel

   I have mixed emotions about this ISMP Best Practice as it relates to IV Workflow medication safety.

   To elucidate this, I need to break down the best practice into it’s defined components:

   (1) Perform an independent verification to assure that the proper ingredients (medications and diluents) are added.

   This independent verification of ingredients prior to compounding could be accomplished by barcode scanning or by direct inspection by a second qualified person. Since virtually all medications and diluents have a barcode, barcode scanning would be the preferred method to do this. Besides, involving a second person does not prevent a human-slip type error by both parties during the checking process. Therefore, it is my opinion that a barcode check of CSP ingredients (medications and diluents) is the safest and most efficient method to accomplish this objective.

   (2) Perform an independent verification…including confirmation of the proper amount (volume) of each ingredient prior to its addition to the final container.

   This is the part of the Best Practice that I struggle the most with. Without technology, the only means to accomplish this is for a second person to visually inspect the volume in the drawn-up syringe prior to adding the contents of the syringe into the final container.

   I agree with the independent verification of the drawn-up syringe for high-alert, high-risk medication medication orders (e.g., chemotherapy, pediatrics, intrathecal), but I feel it is impractical for other routine, lower risk, CSP preparations.

   The Best Practice encourages the use of verification technologies (e.g., barcode scanning verification of ingredients, gravimetric verification, robotics, IV workflow software). Although, with the exclusion of the barcode scanning of ingredients, there are only limited ways to fully utilize these IV Workflow safety technologies to complete the second phase of CSP verification (i.e., independent verification of the correct drug amount prior to addition to the final container).

   All of the available IV Workflow technologies utilizes barcode scanning up front in the process. That should be the minimum requirement for EVERY CSP, individual or batch, prepared by the Pharmacy.

   For the technologies that primarily use the photo capture of the technician’s workflow process (e.g., DoseEdge, MedKeeper), this Best Practice requires the pharmacy technician to take a picture of the drawn-up syringe and obtain verification by a remote pharmacist BEFORE proceeding. After the pharmacist has confirmed the volume in the syringe by viewing the photo image, then the technician may complete the CSP preparation.

   For the technologies that use gravimetrics, with or without workflow process photo capture, (e.g., BD-Cato, i.v.SOFT), this Best Practice would require the gravimetric verification of the syringe prior to addition to the final container. The Best Practice would NOT permit the use of a terminal gravimetric verification check on the final container as a method of verification.

   Therefore, I feel the Best Practice should better define how IV Workflow safety technologies should be used when an interim syringe check in not required (e.g., lower risk CSPs).

   I propose the following modifications to the original ISMP Sterile Compounding Best Practice:

   (1) Barcode scanning must be utilized for verification of all CSP ingredients (e.g., medications and diluents) prior to addition to the final container and for verification of a pre-mixed products before patient labeling.

   (2) Interim syringe verification, to confirm the proper amount (volume) of each ingredient, must be used for for high-risk/high-alert medication orders prior to addition to the final container. This may be accomplished, either by the use of gravimetric syringe verification or by visual inspection by the pharmacist (i.e., directly or by viewing a photo image of the drawn-up syringe).

   (3) Syringe volume verification after addition to the final container may be used for lower-risk CSP preparation. This could be performed using either gravimetrics, photo-capture of the IV Workflow process steps, or other methods to determine the volume drawn up with a syringe (e.g., direct inspection by a pharmacist via a live, remote camera focused into the hood; photo-determination of syringe volume, etc.).

   Refinement of these best practices, as defined above, allows the pharmacy department to risk-assess their CSP production processes and make corresponding, optimal use of IV Workflow medication safety technologies.

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