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By: Sheldon Sones
Published: 4/15/2019
Instead of discarding unused fentanyl in real time, your anesthesia provider aggregates all discards and brings them out for witnessing by another licensed professional at the end of each day. Sounds like an efficient way to handle discards, right? Wrong.
Here’s the issue: Potential drug diverters may see this process as an opportunity to substitute the fentanyl for a substance like saline. At the end of the day, the witness will only see clear liquid and have no way of discerning the actual contents within.
Thanks in large part to the opioid crisis, your controlled substance practices are under the microscope. Documentation is your best friend here. You need to create an easy-to-follow trail of controlled drug withdrawal from the PACU to the ORs each day, with documentation of the when — and by whom (at least 2 licensed individuals).
To prevent diversion, you’ll want to ensure a licensed individual witnesses discards of partial portions of any controlled substance. Both the discarder and witness should sign off at the time of discard. You should also validate a count of the controlled drug cabinet at the beginning and end of each day.
Many facilities keep their controlled substances in a safe as well as in a PACU cabinet. Your safe will ultimately stave off diverters. First, you’ll need to ensure the safe is appropriately protected and that only a few (I recommend no more than 3) authorized individuals have access to the combination. Generally, this is the clinical director, PACU manager or the “pharmacy nurse” and the medical director or the holder of the controlled drug registration certificate. You’ll also need to ensure the count — a count that should always include expired drugs — within the safe is validated and documented at least monthly or upon the withdrawal of the medication for facility distribution. But keep in mind, some states require more frequent validation/documentation.
When it comes to controlled substances, you should also make every effort to minimize stocking various strengths of drugs. How? Adjust the formulary as much as possible to minimize the calculations of drugs on hand and the potential for error. Many medication errors, especially those involving pediatric patients, are the result of a provider or medication administrator using the wrong strength of a controlled substance. These potentially catastrophic mistakes can be greatly reduced (if not eliminated) through a bare minimum approach to stocking various strengths of drugs. However, this can be difficult — particularly with pediatrics and certain classes of drugs such as anesthetic injectables. If multiple strengths of drugs are essential, distinct “Look-Alike/Sound-Alike” (LASA) drug auxiliary labels, different color narcotic-use forms and separation in storage areas are all proven error-reducing tactics.
If you’re considering using a compounding pharmacy to offset the recent drug shortages, be sure to carefully vet the compounders you use. At a minimum, the pharmacy must be state-licensed and 503B-registered. After all, it wasn’t too long ago that we witnessed the 2012 New England Compounding Center (NECC) disaster where a strip-mall pharmacy singlehandedly caused a nationwide outbreak of fungal meningitis by selling vials of injectable steroids that were tainted with the deadly fungus that left 64 dead and 753 injured. Here are 2 proven ways to properly vet compounders:
Make sure compounders fulfill the “attestation tools” and meet all compounding requirements. Any compounder you use should, at a minimum, meet The American Society of Hospital Pharmacists’ (ASHP) “Guidelines on Outsourcing Sterile Compounding Services” (osmag.net/eyK7FE). Additionally, you can download this form at outpatientsurgery.net/forms to make sure a potential compounder meets minimum requirements and compares favorably with other compounding vendors.
Review recent FDA findings on inspections of compounding pharmacy providers. Before using the services of a compounder, you’ll want to find out if there are any red flags about its current or past practices. The FDA provides a wealth of info on facility inspections and recalls online, and you can access this info through a simple Google search. Type “Compounding pharmacies FDA inspections” into your search engine, and you’ll find outcomes that validate FDA-successful reviews. Go to osmag.net/7RrPkC for a listing from the FDA’s website of “Compounding: Inspections, Recalls, and other Actions.”
You’ll never completely prevent medication mishaps from occurring, but you can come pretty close. Make sure all drug labels for pre-drawn medications have each of the 5 required elements (drug name, strength, time drawn, initials of preparer and date drawn). Have a policy for both multiple- (MDVs) and single-dose vials (SDVs).
If you stock secured drug samples, you must somehow track everything from their entry into your facility until they’re dispensed. Finally, reversal drugs such as flumazenil, naloxone, methylene blue and lipids (Intralipid, for example) must be readily available.
To prevent common medication errors, use these best practices:
Because you use your emergency/MH cart in high-pressure situations, it’s critical to make sure everything is exactly as it should be on a regular basis. At least monthly, rotating staff members should review the cart contents to ensure widespread familiarity. During the review, make sure all drugs are within the manufacturer’s expiration date (hint: purchase soon-to-expire drugs a month ahead). Your Medical Executive Committee should approve (in writing) your official list of cart contents. Security is paramount, but you’ll want to use breakable locks — as opposed to key locks. Keep replacement locks with managers, not in the cart.
When stocking dantrolene on your MH cart, make sure you have a minimum of 36 vials and at least 2400 mL of sterile water without preservative (preferably in 100 mL vials, not large plastic bags). If you use a newer product such as Ryanodex, ensure you have the correct amount and diluent (osmag.net/tb3FMD). You’ll also want to cross-reference your MH supplies with the Malignant Hyperthermia Association of the United States’ (MHAUS) list of suggested supplies (osmag.net/Nnd5MQ).
If you serve pediatric patients, make sure the pediatric dosage guidelines and pediatric strength meds such as preloaded syringes (atropine and dextrose, for example) are readily available.
When it comes it medication safety, my philosophy has always been to envision myself or a family member was the one lying on the operating table and to ask, “What would I want as the optimum therapies, including drugs, used in the facility?” OSM
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