Here are some more questions dealing with expiration dates that we received during the live webinar:
Q: Does the 28 day exp. date apply to vaccines that are NOT supplied by the CDC?
A: The 28 day dating expectation does not apply to vaccines in the Centers for Disease Control and Prevention and state immu- nization programs, but does apply to vaccines not in these programs.
Q: Can you clarirfy expiration dating for single dose vials with a manufacturer exp. date longer than the BUD of 6 hours (ex: daptomycin PI states 48 hours after reconstitution)?
A: We expect you to follow the manufacturer's recommendation. We do not allow multi-dose use of single dose vials.
Q: Can you provide guidance on the time period for the expiration date for oral solids that are taking out of bulk bottles and put into a prescription vial in the patient’s med drawer? Similarly, what about bulk liquids transferred to smaller bottles for patient-specific use?
A: We have no specific requirements, but USP has standards related to this. I believe it is 1 year.
Q: if manufacturer has information that it is stable for this extended duration, can pharmacies store a refrigerated medication (ie, succinylcholine) out of refrigerator longer than package insert states,
A: If you have information obtained directly from the manufacturer, that is sufficient and you can use that date. But if it is from another source, you must use the manufacturer's recommendations.
My question is medication security in the OR setting. Our OR is set up with a medication cart that is stored in the OR in the center core. This cart is not under constant surveillance by nurses since outside of the OR rooms and OR center core techs are there doing their duties. Each OR room has an anesthesia cart in each room. My question is does this medication cart have to be locked since center core techs are in the area and do not have authorization to medications?
A> The medication cart is considered in a secure area while the OR is functioning. If the OR complex is closed, then the OR complex must be locked or the cart must be put into a room that is locked.
I was hoping for clarification on one issue discussed in the seminar. The issue involves mobile vs. non-mobile carts and requirements for the devices to be behind a locked door. Would an automated anesthesia cart (on wheels) be considered mobile? Would the keyed locks on the cart itself be sufficient to meet the standards?
A hospital with five CRNAs has a current practice where the CRNAs each have a locking mobile cart for their supplies. They keep their drug trays in the carts, and the trays include controlled substances. Rather than return the trays to the Pharmacy at night, they keep them in the mobile carts for several days at a time (basically until they run out of drugs). These carts are in the Surgery department, which is secure, and locked at night. I am told that each CRNA has a unique code for these carts and do not know each other's combinations. In summary, the mobile carts are locked and in a locked department, and contain controlled substances. Housekeeping does clean at night, and there is a policy in place allowing this as required. Is this still in violation of any JC or CMS standards as related to med storage and security? Your opinion will be appreciated. Thank you.
Here are some more questions featured from our live webinar:
Q: Do Code Blue/Crash Carts need to be kept in a locked room?
Q: If a crash cart is kept at a nurse station is that considered under constant surveillance, even if the station is not always staffed, but is under video surveillance?
Q: Is there a standard or interpretation regarding the expected number of crash carts per patient (aka, some ratio)?
Q: In regards to concentrated electrolytes on crash carts there used to be a qualifier for magnesium that it should not exceed a certain volume (i.e. 4mL) before it was considered a concentrated electrolyte. Is that still the case?
Q: With all the current product shortages, how does TJC survey medication carts when the product is not available commercially---is detailed labeling adequate???
Just an interprtation issue. We feel that any "drug" left at the bedside of a patient would be unacceptable as we read the MM standards (we don't have any policies for self administration). Our management team feels they have been told it is OK to leave at bedside prefilled Normal Saline Flush syringes, and Normal Saline for Inhalation "bullets" as these are "Central Supply items" and are not drugs. What woould be Dr. Rich's call?
I am a former surveyor (17 years as a surveyor and 14+ years as a Program Manager of enforcement and regulatory programs for both Medicare and state licensure) from a large Dept. of Health in a Mid-Atlantic State. I currently practice as both a staff pharmacist in the outpatient setting of a regional medical center and consultant to hospital-owned medical practices, and also conduct seminars on regulatory and medication error issues.
There is no regulation or guideline that I am aware of that discusses open containers such as Betadine Solutiono or Phisohex. I always looked at the manufacturer's expiration date. However, for over-the-counter liquids that may not have an expiration date, my understanding from an old FDA guideline was that these products have a shelf life of 3 years from the date of manufacture. Unfotunately, you need to contact the manufacturer to decipher the codes for those dates. Also, I would inspect the containers carefully for labeling that may have disappeared or worn off and dirty containers. Finally, the institution or facility can always have their own policy on how long to keep these items. Most Medicare and/or state regulations are minimal, so facilities can always be more stringent.
06-09-201010:29 PM - last edited on 06-09-201010:33 PM
ct73 wrote:
I was hoping for clarification on one issue discussed in the seminar. The issue involves mobile vs. non-mobile carts and requirements for the devices to be behind a locked door. Would an automated anesthesia cart (on wheels) be considered mobile? Would the keyed locks on the cart itself be sufficient to meet the standards?
Thank you!
A: The following is from the CMS interpretative guidelines;
"Due to their mobility, mobile nursing medication carts, anesthesia carts, epidural carts, and other medication carts containing drugs or biologicals (hereafter, all referred to as "carts") must be locked in a secure area when not in use. Hospital policies and procedures are expected to address the security and monitoring of carts, locked or unlocked, containing drugs and biologicals in all patient care areas to ensure their safe storage and to ensure patient safety.Medication automated distribution units with security features, such as logon and password or biometric identification, are considered to be locked, since they can only be accessed by authorized personnel who are permitted access to the medications. Such units must be stored in a secure area."
Thus, we would expect the automated anesthesia carts to be locked when they in the OR and not in active use. The keyed locks on the cart would be sufficient if the area is secure (active staff and providing patient care). If the area is not actively staffed or providing patient care, the locked carts must additionally be put into a locked room or the entire OR locked.
