JC Finding - hand writing on prescription medication pill bottle

[DrZRx]

Good morning everyone,
we have TJC here surveying us.
we have a special program where an interdisciplinary team goes into the pts home for their primary care.
The NP is the primary prescriber/provider and can fill mediplanners, provide medication education, etc.
This patient is cognitively impaired. There was a change to his guaifenesin order - from scheduled to PRN.
so it was taken out of his mediplanner and the bottle was available. The NP changed crossed out old dose, hand wrote on the bottle the new dose with her initials and the date.
The Joint Commission issued this as a finding stating

“When an individualized medication(s) is prepared by someone other than the person administering the medication, the label includes the following: Directions for use and applicable accessory and cautionary instructions.”

Our SOP states that "HBPC providers, pharmacists and nursing staff are responsible for: instructing patients and/or caregivers in the use and purpose of medications; medication labeling; "

I wonder if this is because they see it as mislabeling? Because it is being done by an NP and not a pharmacist?
I'm not sure but we are trying to think of a rebuttal ASAP today so they will hopefully take it away.

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[DrZRx]

Additional information:
The standard they provided was


MM.05.01.09: Medications are labeled.

Rationale: A label on every medication and medication container has long been a standard of practice by the pharmacy profession and is required by law and regulation. A standardized method to label medications and containers promoted medication safety.

Elements of performance

12. “When an individualized medication(s) is prepared by someone other than the person administering the medication, the label includes the following: Directions for use and applicable accessory and cautionary instructions.”

 

[Niosh]

I don't understand their problem. As far as I know there is nothing wrong with a hand written label vs printed given it contain all legally required information. Which if the NP just crossed off the old instructions and wrote new ones, I'd think it'd be just fine.

Edit for the additional info, are they saying a written label isn't sufficient then? Or isn't following the standardized method of labeling?

 

[DrZRx]

I don't understand their problem. As far as I know there is nothing wrong with a hand written label vs printed given it contain all legally required information. Which if the NP just crossed off the old instructions and wrote new ones, I'd think it'd be just fine.

Edit for the additional info, are they saying a written label isn't sufficient then? Or isn't following the standardized method of labeling?

I think they are thinking because the pharmacy created the original label from the original script and prescriber. Now the covering provider adjusted the label - that , for some reason it is not legal and appropriate to edit/adjust that original label.

 

[bacillus1]

I think they are thinking because the pharmacy created the original label from the original script and prescriber. Now the covering provider adjusted the label - that , for some reason it is not legal and appropriate to edit/adjust that original label.

Are all legal parts of the prescription on the new label, such as the new prescriber's full name and the date that the new instructions started? If not, then it's not a legal label. In addition, is this a VA? You really should be updating meds in CPRS so the patient has a complete medication list. One way of going around that without dispensing a new bottle is edit the rx in CPRS and then placing it on hold.

 

[DrZRx]

yes it was updated in CPRS as well. and it was updated dose (handwritten) with date and initials of provider.

 

[bacillus1]

Just looked up my state's law: "Tampering with label prohibited.- So long as any of the original contents remain in the container, a person may not alter, deface, or remove any label required by this section."--I am not sure if the VA is subject to whatever state law says in your state, or if there is any federal law or regulation like this--but this may be the problem. Also I have a problem with the prescriber's full name not on the bottle, in case they need to be tracked down for adverse effects, but I am not sure if there is a law regulating that.

 

[zelman]

As stated by others, the only issue with this is an old provider's name on the label.

 

[ldiot]

I think they need to get a life if you want to know the truth. But they may consider it tampering with the label or have an issue with the prescriber on the label as others have mentioned.

 

[Sparda29]

I wonder how this applies to retail. We have a few patients who don't speak any English and ask that the indication be written in Spanish on the label. I have my spanish speaking tech tell me how the indication translates into spanish and I write it.

 

[ldiot]

I wonder how this applies to retail. We have a few patients who don't speak any English and ask that the indication be written in Spanish on the label. I have my spanish speaking tech tell me how the indication translates into spanish and I write it.

What is the state board going to go to their house and check? lol. Just don't do it if an inspector is standing next to you. Or just put it in the sig

 

[bacillus1]

I wonder how this applies to retail. We have a few patients who don't speak any English and ask that the indication be written in Spanish on the label. I have my spanish speaking tech tell me how the indication translates into spanish and I write it.

This should be OK, as it's the original label, and you're not really "altering" or "crossing out" anything, just adding Spanish instructions.

 

[Ackj]

I wonder how this applies to retail. We have a few patients who don't speak any English and ask that the indication be written in Spanish on the label. I have my spanish speaking tech tell me how the indication translates into spanish and I write it.

NY had some changes where certain aspects of the label must have a font of a certain size now to help people read it better. Our entire labels were redesigned for that purpose maybe 2 years ago. Handwriting might not meet requirements, although I don't know the law verbatim.