Sig line with Warning: Okay or Not. Quick answer please. Thank you very much.

[molyhelp]

Dear Colleague,
Please give your thoughts on this discussion:
Patient was given warfarin 1 mg, 30 pills, 1 pill a day. That should last 30 days.
After 14 days, warfarin 1 mg is not enough, doctor gives new instruction (patient still has 16 pills of warfarin 1 mg.)

If doctor writes:
STOP WARFARIN 1 MG.
START WARFARIN 2 MG, TAKE 1 TABLET BY MOUTH DAILY. DISPENSE: 30 PILLS. REFILL: 3.
My official label has this information:
WARFARIN 2 MG
TAKE 1 TABLET BY MOUTH DAILY. STOP WARFARIN 1 MG.

What do you think about the sig:
TAKE 1 TABLET BY MOUTH DAILY. STOP WARFARIN 1 MG.

My reason to put “STOP WARFARIN 1 MG.” in the sig line is:
I want to counsel in writing. I heard of malpractice lawsuit where:
New dose was given with verbal counseling that patient should stop old pill.
But patient took both old pill and new pill and overdosed and sued pharmacist for overdosing.
In lawsuit, of course, patient claimed the pharmacist never counseled me to stop old pill so I took both old pill and new pill.
Because of that lawsuit, I always put extra warning directly in the sig line so no patient can go back and claim that I did not warn about stopping old pill.

However, my manager insisted that: we all should not add ANYTHING to sig line and for ANY WARNING for any medication, we should only write a piece of paper to put in the bag and counsel verbally and when patient signs, we make sure patient marks that “I have been counseled.”

I have a few worries with that method:
If patient died because of overdose, the family will claim pharmacist did not counsel.
The evidence that ‘’patient signed and marked “I have been counseled”’’ can be claimed by attorney that: pharmacist counseled about side effects but still did not counsel about “stopping old pill.”

I discussed with a few friends and we agree that: the solid proof of counseling to prevent overdosing is on the label which is on the vial. If patient claims pharmacist did not counsel about “stopping old pill”, my defense would be: “Show me the label. You took the pill from the bottle, you have duty to read the label. On the label, I did my duty and wrote “stop old pill.” That’s solid counseling to me.
If I hand write a piece of paper, somewhere along the line, the paper may fall off the basket, or paper may drop out of bag when tech pulls med out, or get lost and hidden inside all the printouts. In my heart, even if patient does not sue later, I do not want any patient to suffer overdosing on my watch.
Therefore, the only solid proof of warning is: on the sig line.
Is there any legal reason why we should not put warning in sig line as a defense in malpractice lawsuit?

Am I missing something in the law book that says we can not add extra warning to sig line? (My manager has 7 years of experience so he may know things I do not know yet)? I have respect for him at the same time worrying about patient’s life as well as my license if warning for prevention of overdosing is lost or not clear.

Would you put that warning in sig line? Please give your quick answer and vote (Vote is at the top of this post).

Thank you very much.

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[mona2004]

Dear Colleague,
Please give your thoughts on this discussion:
Patient was given warfarin 1 mg, 30 pills, 1 pill a day. That should last 30 days.
After 14 days, warfarin 1 mg is not enough, doctor gives new instruction (patient still has 16 pills of warfarin 1 mg.)

If doctor wrote:
STOP WARFARIN 1 MG.
START WARFARIN 2 MG, TAKE 1 TABLET BY MOUTH DAILY. DISPENSE: 30 PILLS. REFILL: 3.
My official label has this info:
Warfarin 2 mg
TAKE 1 TABLET BY MOUTH DAILY. STOP WARFARIN 1 MG.

What do you think about the sig:
TAKE 1 TABLET BY MOUTH DAILY. STOP WARFARIN 1 MG.

My reason to put “STOP WARFARIN 1 MG.” in the sig line is:
I want to counsel in writing. I heard of malpractice lawsuit where:
New dose was given with verbal counseling that patient should stop old pill.
But patient took both old pill and new pill and overdosed and sued pharmacist for overdosing.
In lawsuit, of course, patient claimed the pharmacist never counseled me to stop old pill so I took both old pill and new pill.
Because of that lawsuit, I always put extra warning directly in the sig line so no patient can go back and claim that I did not warn about stopping old pill.
However, my manager insisted that we all should not add anything to sig line and we should only write a piece of paper to put in the bag and counsel verbally and when patient sign, we make sure patient marks that “I have been counseled.”

I have a few worries with that method:
If patient died because of overdose, the family will claim pharmacist did not counsel.
The evidence that ‘’patient signed and marked “I have been counseled”’’ can be claimed that pharmacist counseled about side effect but still did not counsel about “stopping old pill.”

I discussed with a few friends and we agree that: the solid proof of counseling to prevent overdosing is on the label which is on the vial. If patient claim pharmacist did not counsel about “stopping old pill”, my defense would be: “Show me the label. You took the pill from the bottle, you have duty to read the label. On the label, I did my duty and wrote “stop old pill.” That’s solid counseling to me.
If I hand write a piece of paper, somewhere along the line, the paper may fall off the basket, or paper may drop out of bag when tech pulls med out, or get lost and hidden inside all the printouts. In my heart, even if patient does not sue later, I do not want any patient to suffer overdosing on my watch.
Therefore, the only solid proof of warning is: on the sig line.
Is there any legal reason why we should not put warning in sig line as a defense in malpractice law suit? Am I missing something because my manager has 7 years of experience? I have respect for him at the same time worrying about patient’s life as well as my license if warning for prevention of overdosing is lost or not clear. Would you put that warning in sig line? Please give your quick answer. Thank you very much.

 

[mona2004]

I always add the stop ... at the end of sig and also put a consultation notice and also put a piece of paper indicates stop ...... .with warfarin also I am calling pt and if I get a chance to talk to pt I will notify pt over the phone too and of course document it on hard copy. Should be very careful before dispensing a new sig or strength with warfarin.

 

[Wheresmyaricept]

If it's something like warfarin, then yes, it is acceptable. I always include directions like that. Better safe then sorry. Politely tell the manager that you don't want something to come back and bite you in the butt, so you're extra careful. Maybe the physician knows this person has Alzheimer's or dementia and will forget to not take the 1 mg. How often do we get the full story behind a script? Just keep doing what you're doing.

What's he going to do? Write you up for transcribing what was actually on the prescription?

 

[WVUPharm2007]

That's perfectly fine. There's never anything wrong with giving more information that legally required.

 

[Ackj]

If it's written on the rx, yes, write it on the sig. Otherwise you're giving out incomplete instructions. That would be similar to the rx saying "1 tablet daily before meals" and you simply writing "1 tablet daily." The "stop" was part of the directions.

However, if the rx did not say to stop 1mg, I would not include it, because we all know how often warfarin doses can change, and perhaps in a week or two they will be taking some of the 1mg tabs again.

For your lawsuit concerns, I don't know how far you would get with "you have duty to read the bottle." Patients don't always read their bottles, and I don't think having something on the vial will be sufficient evidence if they claim they were not counseled. They get handed a big packet of paper full of side effects and instructions; that does not count as counseling.

 

[Digsbe]

I'm just a student, but if it is in the sig line I would put it on the label. Why does the manager have an issue with it? I don't really see how it could be a big problem.

 

[trailerpark]

For your lawsuit concerns, I don't know how far you would get with "you have duty to read the bottle." Patients don't always read their bottles, and I don't think having something on the vial will be sufficient evidence if they claim they were not counseled. They get handed a big packet of paper full of side effects and instructions; that does not count as counseling.

So couldn't a patient sue about anything and just say they weren't counseled regardless of the pharmacist writing something on their sig, documenting on the prescription, counseling during pick up, signing they were counseled, etc...? I mean what else are we supposed to do in order to protect ourselves...

 

[Kelp103]

Umm... It's in the original sig. My pharmacist would yell at me for NOT putting it in there. I don't really get what your manager is saying :-/

 

[pezdispenser]

I would definitely put the "stop warfarin 1mg" on the label because counseling in my state is almost non-existent.

If I could, I would also go ahead and close out any refills on discontinued meds. We have a lot of patients who just call up and ask the tech to "refill all my meds", and of course the tech could mistakenly refill something that is not current.

 

[KidPharmD]

I would see no problem putting it on the label. However, I might use an auxiliary label so it is only on the first bottle.

In addition, I do not think this is part of the sig for the new dose warfarin.

I see two orders here
1. Stop Warfarin 1 mg
2.Warfarin 2mg SIG: Take 1 tablet by mouth daily.

 

[zelman]

So couldn't a patient sue about anything and just say they weren't counseled regardless of the pharmacist writing something on their sig, documenting on the prescription, counseling during pick up, signing they were counseled, etc...? I mean what else are we supposed to do in order to protect ourselves...

I could literally sue you for inducing anxiety with this post. Being able to sue someone and being able to win a lawsuit are two very different things. You do the right thing and carry malpractice insurance, and you'll be just fine.

 

[confettiflyer]

I once had a community pharmacy instruct one of my patients to IGNORE the warfarin regimen that I gave him that morning in clinic because the sig on the bottle (from 4 refills ago) said otherwise.

He wasn't demented, but he was easily confused in general. I gave him a specific dosing calendar each visit.

I only found this out 2 weeks later when his INR went to 1.1 and he gave me an old/wacky dosing regimen, later admitting his retail pharm told him to follow the directions in the bottle and nothing else.

I wonder who, if anyone, would be liable if he threw a clot from that event (if anything could ever be proven, expired patients can't be deposed).

 

[owlegrad]

I would not type it into the sig personally. I would just put a forced counseling note on the prescription to inform patient to stop the 1 mg strength. I see no liability whatsoever from dispensing in this manner. Having said that I do not see what your manager's issue is with this. Including it or not including it both seem very reasonable to me.

Do you make every decision in the pharmacy based on liability? I think you are blowing the liability angle way out of proportion. Do you plan to add every counseling point into every sig line as a defense and proof of counseling?

 

[Kaipo]

I was told by corporate that adding anything to the sig that the dr didn't authorize was considered mislabeling.

 

[BidingMyTime]

I once had a community pharmacy instruct one of my patients to IGNORE the warfarin regimen that I gave him that morning in clinic because the sig on the bottle (from 4 refills ago) said otherwise.

He wasn't demented, but he was easily confused in general. I gave him a specific dosing calendar each visit.

I only found this out 2 weeks later when his INR went to 1.1 and he gave me an old/wacky dosing regimen, later admitting his retail pharm told him to follow the directions in the bottle and nothing else.

I wonder who, if anyone, would be liable if he threw a clot from that event (if anything could ever be proven, expired patients can't be deposed).

If you had changed the patient's dosing, then why would you not immediately send a new prescription to the pharmacist? If the patient is easily confused, he probably called the pharmacist and asked him how to take his medicine, so of course, the pharmacist told him based on the last prescription he had received from you. The other problem is insurance billing requires days supply, if you changed how the patient is taking his warfarin, that will undoubtedly cause an insurance rejecting for early refill, and if its a weekend, the patient will have the choice of paying cash or going without warfarin until your office opens so a new prescription can be gained.

Pharmacists have to deal with this kind of thing all the time, every weekend some patient will be requesting an early refill on something, because their dose has changed, but there is no new prescription on file. Please, for your patient's safety (and to make it possible to bill their insurance), anytime you verbally tell a patient to change how they are taking their medicine, send a new prescription to their pharmacy to document this.

 

[confettiflyer]

If you had changed the patient's dosing, then why would you not immediately send a new prescription to the pharmacist? If the patient is easily confused, he probably called the pharmacist and asked him how to take his medicine, so of course, the pharmacist told him based on the last prescription he had received from you. The other problem is insurance billing requires days supply, if you changed how the patient is taking his warfarin, that will undoubtedly cause an insurance rejecting for early refill, and if its a weekend, the patient will have the choice of paying cash or going without warfarin until your office opens so a new prescription can be gained.

It's Coumadin, I don't have time to call in/send new prescriptions every damn time the dose changes. Sometimes it's twice a week, sometimes I instruct patients to hold a day or reduce by a day d/t abx treatment. Pharmacies would freak out if I were to send down instructions that looked like "Take 2.5 mg 5/19 and 5/20, then 5mg a day except MWF take 2.5 mg." My sigs are usually the last known dose + a proviso about per clinic dosing (example sig: "Take 5mg daily, or as directed by Coumadin Clinic.") cuz apparently UAD isn't allowed due to the days supply thing, and I anticipate the whole days supply issue by issuing purposefully liberal dosing.

The CYA part of it is "or as directed by Coumadin Clinic" and the fact that I chart what I told the patient. That will trump any out of date Rx label on the shelf.

Pharmacists have to deal with this kind of thing all the time, every weekend some patient will be requesting an early refill on something, because their dose has changed, but there is no new prescription on file. Please, for your patient's safety (and to make it possible to bill their insurance), anytime you verbally tell a patient to change how they are taking their medicine, send a new prescription to their pharmacy to document this.

See above comment about purposefully liberal days supplies. I do this with insulin too whenever I need to call things in (very rarely). I issue instructions like "Test up to 10x/day" for strips and "Use up to 120 units of insulin per day sliding scale (or insulin pump)" knowing that the actual usage is much less.