07-13-2017 10:46 AM
Hi Eric: Several pharmacists in my institution had some inquiries regarding the USP 797 provision on immediate-use compounding when performed by nursing. USP 797 states that only under emergency situations (such as cardiopulmonary resuscitation..etc) , nurses are allowed to compound in the patient care areas, however, the compound needs to be a low risk CSP (3 or less ingredients or less than two entries in a vial/bag, etc). If there is a case where a patient is seizing and the nurse needs to prepare Phenobarbital IV 500 mg (which includes a total of 5 ingredients), and it needs to be administered immediately, does USP 797 make an exception in this situation? If this is not acceptable, are there any alternatives offered by USP 797 or any suggestions from your personal experience?
Thank you for your assistance.
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07-14-2017 08:37 AM
There aren't exemptions for CSPs that fall out of the traditional definition of immediate-use provisions. Why are the nurses mixing the phenobarb vs. pharmacy? Is the pharmacy open 24/7? You can certainly define this practice internally as an emergency situation based on your example. If you have an emergency medical situation, then the immediate-use rules would be in effect. The key issue, in my opinion, is do the nurse's use good aseptic technique?
07-14-2017 10:21 AM - edited 07-14-2017 10:26 AM
We have a policy in place for nursing compounding in the patient areas. In the policy, it is stated that nursing personnel must follow aseptic technique , assign a BUD of 1 hr, and only compound low-risk CSP's as determined by USP 797 (only under emergent situations) . My question is the following: For a first dose of Phenobarbital 500 IV (as in the example above), if the nurse follows aseptic technique and taking into consideration that it is a medical emergency (although the compound being prepared is medium-risk level), would this be acceptable for nurses to compound this IV?
If the order for Phenobarb IV is then written by the provider to be continued every 12 hr (as a scheduled med)- this should be compounded by pharmacy as it is a scheduled med and not a STAT (emergency situation).
Please confirm if these statements are correct .
Thank you for your assistance ,
07-14-2017 10:22 AM
I forgot to mention that our pharmacy is 24/7 and has available personnel to compound IV's on every shift.
07-14-2017 11:30 AM
Your description of the process seems to be appropriate. This is not to say that an accreditation organization or board of pharmacy inspector may have a different opinion but if you feel this the best way to care for your patient, then so be it. Hope this helps.