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Industry: Email Alert RSS FeedMedication packaging and labeling
AORN Journal, July, 2007 by Sharon Giarrizzo-Wilson
QUESTION: The medication vendor we use has changed packaging and labeling on some of our frequently used ophthalmic medications. Vials now have similar label colors and very small font size labeling, making it difficult to select the correct medication and distinguish its strength. The packaging on one medication has changed from a dual chamber diluent and powder to a blister pack containing a sterile ampoule and powder vial. The new delivery system requires scrubbed personnel to prepare the medication on the sterile field. Staff members have reported receiving glove punctures when opening the ampoule, and glass shards may contaminate the diluent. Should scrub personnel reconstitute this medication on the sterile field? Should medication manufacturers be required to use larger fonts on medication labels and change similar color-coding? Where should we report our problems with the packaging system and the concerns about changes in medication labeling?
ANSWER: Reconstitution of ready-to-use (eg, sterile) medications on the sterile field is desirable to reduce contamination and protect patients from medication errors. Recommendations from the US Pharmacopeia (USP) 2007 MEDMARX Data Report: A Chartbook of Medication Error Findings from Perioperative Settings from 1998-2005 (1) suggest that medication manufacturers provide products in ready-to-use packaging that allows the medication to be dispensed, with original labeling, on the sterile field. Changes in medication packaging and delivery systems are occurring to accommodate this international safety recommendation.
Perioperative team members should take care when reconstituting medications on the sterile field to avoid sustaining a sharps-induced injury or compromising the integrity of the diluent. Using a folded surgical sponge around the ampoule will help shield the gloved hand and prevent punctures as the scrub person opens the ampoule. After he or she inspects the solution for contamination, the scrub person should attach a filter between the syringe and needle before aspirating the diluent. The scrub person then discards the filter and needle and attaches a new needle to the syringe before injecting the diluent into the powder vial.
Medication manufacturers are required to follow medication labeling and packaging guidelines established by the US Food and Drug Administration (FDA). (2) These guidelines are in place to provide continuity in product identification, but they do allow some flexibility in how the manufacturer exercises implementation. Font size often is small to accommodate all the information that must be included on medication labels. Perioperative team members must remain vigilant when identifying a medication by name and strength to ensure that they prepare and administer the correct medication to the patient.
Medication selection should never be dependent solely on label color-coding. Color-coding that is used to draw attention to medication recognition has been associated with selection errors. (3,4) Similar problems exist when labels are molded into medication packaging (eg, plastic ampoules) or are devoid of color. (3) The best approach for accurate medication selection is to carefully check the medication package and label during selection and before administration. If needed and when directed by facility policy (eg, transferring medications to the sterile field), have a coworker review the selected agent for accuracy in name, dose, strength, and expiration date. (6)
Health care professionals who encounter problematic medication labeling or packaging should submit concerns to a national medication-reporting program. The USP, in collaboration with the institute for Safe Medication Practices, operates the Medication Errors Reporting (MER) Program. The MER Program allows health care professionals to report actual or potential medication errors to the USP confidentially through the Internet. The USP reviews and forwards these reports to the FDA and to the involved medication manufacturer. This program is designed to protect the public and improve medication standards. The MER Program can be accessed at http://www.usp.org.
Editor's note; MEDMARX is a trademark of the US Pharmacopeia, Rockville, MD.
REFERENCES
(1.) Hicks RW, Becker SC, Cousins DD. MEDMARX[R] Data Report: A Chartbook of Medication Error Findings from Perioperative Settings from 1998-2005. Rockville, MD: USP Center for the Advancement of Patient Safety; 2006.
(2.) US Food and Drug Administration. Title 21--Food and drugs, chapter 9--Federal Food, Drug, and Cosmetic Act, subchapter II--definitions. http://frweb gate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname= browse_usc&docid=Cite:+21USC321. Accessed May 29, 2007.
(3.) Institute for Safe Medication Practices. Hazard Alert! Rapamtme. http://www.ismp.org/hazardalerts/A200 10124.asp. Accessed May 29, 2007.
(4.) Fasting S, Gisvold SE. Adverse drug errors in anesthesia and the impact of coloured syringe labels. Can J Anaesth. 2000;47(11):1060-1067.
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