10 Medication Safety Rules to Live By

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Expert advice for sound drug delivery and security.


Who's authorized to administer propofol at your facility? What's your rescue strategy if a patient you've administered propofol to reaches a deeper-than-intended level of anesthesia? If you store dantrolene for malignant hyperthermia, do you have at least 2,400ml of sterile water without preservative — and preferably in 100ml vials rather than large plastic bags? How do you respond to a loss of controlled drugs? Yes, medication safety is a multi-faceted challenge for surgical facility managers. Here are several areas worth reviewing.

1. Clarity of the anesthesia record. You must be able to clearly recount the types of drugs given, when they were administered and their specific dosages. Antibiotic administration, when delivered by anesthesia providers (or pre-operatively by nurses) must be noted in the record along with when they were initiated so you can validate "timeliness" (within 60 minutes of the incision). Finally, ensure that the dosing details of anesthetic agents aren't vague. For example, listing a propofol dose as "20" creates question as to whether it's 20ml or 20mg.

2. Compliance with USP 797. The national standards for sterile product preparation, USP 797 (www.usp.org), have brought into focus how you're to manage and prepare sterile products. Products not for immediate use are to be prepared like they are in acute care hospitals. I'm often asked about the expiration dating of multiple-dose and single-dose vials once they're opened. The following is a direct excerpt from USP 797: "Opened or needle-punctured single-dose containers, such as bags, bottles, syringes, and vials of sterile products and CSPs shall be used within 1 hour if opened in worse than ISO Class 5 (maximum of 3,520 particles up to 0.5 microns in size per cubic meter of air) air quality, and any remaining contents must be discarded. Single-dose vials exposed to ISO Class 5 or cleaner air may be used up to 6 hours after initial needle puncture. Opened single-dose ampules shall not be stored for any time period. Multiple-dose containers (vials, for example) are formulated for removal of portions on multiple occasions because they usually contain antimicrobial preservatives. The beyond-use-date (BUD) after initially entering or opening (needle-punctured, for example) multiple-dose containers is 28 days unless otherwise specified by the manufacturer."

3. Formulary management. How surgical facilities manage their formulary listings has come under recent scrutiny. The document should be functional and embraced in a formal way by the governing medical staff committee. Drugs proposed for inclusion in the formulary should have distinct advantages, be fiscally viable and, above all, have attractive safety indexes.

4. Compounding pharmacy resources. Be sure that your providers of compounded products are compliant with best practice standards and are licensed to provide services in your state.

5. Insulin pump management. Can you safely assist and guide patients who present on insulin pumps? Newer pumps continue to evolve; fortunately, patients who use insulin pumps tend to be extremely competent in their management. How-ever, competency is not a constant during much of the post-operative phase. You should have a written order to enable the continuation of pumps, identifying adequately the actual pump, type of insulin and rates. Develop policies to accommodate usage of pumps.

6. Malignant hyperthermia preparedness (as well as other reversals). If you use triggering anesthetic agents, your staff must be trained to administer reversal agents. An emergent situation should not be the first time someone handles dantrolene. Use outdated products in an in-service environment to train staff on the challenge that dissolution of this product represents. Similarly, you should prepare for bupivacaine-induced cardiotoxicity that requires fat or lipid emulsion reversal. Additionally, awareness of toxicity reversal induced by benzocaine-containing sprays (often used in endoscopy) should be part of the educational agenda.

7. Anesthesia cart security. Access to anesthesia carts should be restricted to authorized individuals, and must be denied when carts are unattended.

8. Recall status. Patients expect that they'll be insulated from drugs that have been deemed unsafe or compromised in a qualitative or quantitative manner. Suppliers should have a track record, that is recoverable on examination, of prompt and thorough communications pertaining to voluntary or regulated recalls.

9. Look-alike/sound-alike lists. These should be available to staff, especially in the admitting area.

10. Controlled drugs. Ensure that there is a trail of withdrawal from the PACU to the ORs each day, as well as documentation of who returned what and when. The discarding of all controlled drugs must be witnessed by another licensed individual. Validate counts of the controlled drug cabinet at the beginning and end of each day. And remember, no erasures or White-Out on controlled drug documentation forms.

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