Question about 6 month, 5 refills for CIII and CIVs?

[trailerpark]

If partial fills are allowed then each dispensing is not considered a refill so basically you can dispense as much as you want to get the total quantity of pills. For example Xanax 0.5 #30 with 5 refills, the patient can get 15 at a time and it's only considered a refill once they get to 30 tablets? They can get all the original then 10 fills of 15 to reach 180?

Also the federal law 5 refills, 6 months only applies to C3 and 4, NOT 5, right?

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[BenJammin]

Straight from the DEA's Pharmacist Manual

A pharmacist may partially dispense a prescription for schedules III-V controlled substances provided that each partial filling is recorded in the same manner as a refilling, the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and no dispensing occurs beyond six months from the date on which the prescription was issued.

 

[trailerpark]

Straight from the DEA's Pharmacist Manual

A pharmacist may partially dispense a prescription for schedules III-V controlled substances provided that each partial filling is recorded in the same manner as a refilling, the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and no dispensing occurs beyond six months from the date on which the prescription was issued.

I don't think CV is under the 6 month/5 refills rule!

 

[BidingMyTime]

I don't think CV is under the 6 month/5 refills rule!

always has been since I've been practicing.

 

[EML9255]

The other day someone brought two Rxs for Xanax in. One was dated 8/18 for one month supply and one was dated 9/18 one month

The customer wanted to fill the one w the 8/18 date and store the 9/18 one. The pharmacist I was working w said she would only fill the 9/18 one.

I was a little confused I don't see why the 8/18 one couldn't have been filled? Nothing was written on it not to fill after certain dates

 

[trailerpark]

Straight from the DEA's Pharmacist Manual

A pharmacist may partially dispense a prescription for schedules III-V controlled substances provided that each partial filling is recorded in the same manner as a refilling, the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and no dispensing occurs beyond six months from the date on which the prescription was issued.

Then why does it also say: (it don't mention CV)
Refills
Schedules III and IV controlled substances may be refilled if authorized on the prescription. However, the prescription may only be refilled up to five times within six months after the date of issue. After five refills or after six months, whichever occurs first, a new prescription is required.

 

[Old Timer]

Then why does it also say: (it don't mention CV)
Refills
Schedules III and IV controlled substances may be refilled if authorized on the prescription. However, the prescription may only be refilled up to five times within six months after the date of issue. After five refills or after six months, whichever occurs first, a new prescription is required.

Because it considers each 30 tablets as a refill. If you get it one at a time or 30 at a time.

 

[owlegrad]

A partial fill is not a refill. I don't know why this is confusing to some people. I know pharmacists that inactivate controls after 5 partial fills because it is 'illegal' to refill it after that. Partial fills are not refills.

Federally CV does not fall under the 6 month/5 refills rule. State laws may differ of course.

 

[owlegrad]

The other day someone brought two Rxs for Xanax in. One was dated 8/18 for one month supply and one was dated 9/18 one month

The customer wanted to fill the one w the 8/18 date and store the 9/18 one. The pharmacist I was working w said she would only fill the 9/18 one.

I was a little confused I don't see why the 8/18 one couldn't have been filled? Nothing was written on it not to fill after certain dates

That is an example of a RPh coming up with their own rules. No law against filling the one from 8/18. The customer didn't even need to present the one from 9/18 and the RPh would have been none the wiser. Was the RPh going to rip up the one from 8/18? What was stopping the patient from using that one next month?

 

[trailerpark]

That is an example of a RPh coming up with their own rules. No law against filling the one from 8/18. The customer didn't even need to present the one from 9/18 and the RPh would have been none the wiser. Was the RPh going to rip up the one from 8/18? What was stopping the patient from using that one next month?

They contradict themselves. The same document from http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/pharm_content.htm
says:
Partial Dispensing
A pharmacist may partially dispense a prescription for schedules III-V controlled substances provided that each partial filling is recorded in the same manner as a refilling, the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and no dispensing occurs beyond six months from the date on which the prescription was issued.

But earlier they say only CIII and CIV:
Refills
Schedules III and IV controlled substances may be refilled if authorized on the prescription. However, the prescription may only be refilled up to five times within six months after the date of issue. After five refills or after six months, whichever occurs first, a new prescription is required.

Are they not contradicting?

 

[Old Timer]

They contradict themselves. The same document from http://www.deadiversion.usdoj.gov/pubs/manuals/pharm2/pharm_content.htm
says:
Partial Dispensing
A pharmacist may partially dispense a prescription for schedules III-V controlled substances provided that each partial filling is recorded in the same manner as a refilling, the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and no dispensing occurs beyond six months from the date on which the prescription was issued.

But earlier they say only CIII and CIV:
Refills
Schedules III and IV controlled substances may be refilled if authorized on the prescription. However, the prescription may only be refilled up to five times within six months after the date of issue. After five refills or after six months, whichever occurs first, a new prescription is required.

Are they not contradicting?

They are not contradictory at all. EACH DISPENSING IS NOT A REFILL Got it? How much simpler is it than that?

 

[trailerpark]

Well then why are they saying no dispensing after 6 months for a CV... as shown in the top statement... I get the first part of my question now, but still confused with the CV thing.

 

[MountainPharmD]

A partial fill is not a refill. I don't know why this is confusing to some people. I know pharmacists that inactivate controls after 5 partial fills because it is 'illegal' to refill it after that. Partial fills are not refills.

Ahhhh an oldie but a goodie! I've had many an argument over this. Usually with the part time back alley lawyer/pharmacist who loudly proclaims "I'm not doing that because its against the law" yet can't quote or find the law to support their position.

What's so hard to understand about a partial refill? The law doesn't say the prescription can only be dispensed 5 times in 6 months. It says the prescription can be refilled a max of five times in six months.

Ambien 10mg, 1 po qhs prn #30, Refills = 5, written 09/20/2014.

6 months = 09/20/2014 to 3/20/2014
Total tablets authorized = 180

The prescription can be dispensed for any quantity less than 30 as long as the dispensing occurs before 03/20/2014 and does not exceed 180 tablets.

It is perfectly legal for the patient to come in every 5 days and get 5 tablets. This would generate 36 partial dispensings with every 6th fill equaling a full refill. At no time did the patient get more than the doctor authorized nor did the patient get more than the prescribed number of full refills the doctor authorized.

 

[trailerpark]

I understand that now, but does it apply to CV because what I posted was from the same document which in 1 part says it does and later on says it doesn't.

 

[zelman]

They are not contradictory at all. EACH DISPENSING IS NOT A REFILL Got it? How much simpler is it than that?

I both understand and agree. However, people get confused by insurance company rejections starting at refill #6, so at there's an origin for this misinformation, and a practical reason to treat it as though it were true.

 

[Dr Wario]

The funniest thing in this thread is 180 Xanax for a 6 month supply LOL

 

[BidingMyTime]

A partial fill is not a refill. I don't know why this is confusing to some people. I know pharmacists that inactivate controls after 5 partial fills because it is 'illegal' to refill it after that. Partial fills are not refills.

You are 100% correct, but it confuses people because they think about CII, and how they are only allowed a single fill (with the 72 hour exception thing), if someone chooses to get a partial fill of 15 days, it counts as the 1 fill and the rest of the RX is cancelled out. So people start thinking the partial fill of the CIII-IV-V counts the same (it doesn't), but it is easy to see why people get confused.

The funniest thing in this thread is 180 Xanax for a 6 month supply LOL

some people would think that is only a 1 month supply.

 

[EML9255]

some people would think that is only a 1 month supply.

Yeah I did a refill for 240 yesterday. 8 a day.

 

[owlegrad]

Are they not contradicting?

No they are not contradicting, partial fills and refills are not the same thing.

 

[farmadiazepine]

I both understand and agree. However, people get confused by insurance company rejections starting at refill #6, so at there's an origin for this misinformation, and a practical reason to treat it as though it were true.

Benecard PBM

 

[FarmD711]

No they are not contradicting, partial fills and refills are not the same thing.

He's not asking what you all think he's asking.

The portion of the manual addressing partial fills refers to CIII, CIV, and CV and discusses a 6 month limit.

The portion of the manual addressing refills only refers to CIII and CIV.

He is asking if CV has a 6 month limit as the manual doesn't specify under the refills section.

 

[pezdispenser]

Also the federal law 5 refills, 6 months only applies to C3 and 4, NOT 5, right?

It does look contradictory. But first check if your state has a time or refill limit on C-V anyway. For example, Florida lumps all of C-III, C-IV and C-V together and limits them to 5 refills and 6 months, so we are not affected (Statute 893.04(1)(g)).

Oh and the Walgreens computer system does close out an Rx even after 6 partial fills, so you have to manually copy the Rx and start a new one to continue partially filling it until they exhaust the prescription. Happens all the time to Suboxone patients.

 

[trailerpark]

My state lets you fill CV for up to a year like non controlled medications, but that doesn't change the federal law saying 2 different things.

 

[pharmalt82]

I am currently studying for a law exam. I will use NYS as an example.

A patient walks in with an Rx for Ambien 10mg QHS #30, 5 refills, Dated 09/21/14.
This is a new Rx. The patient has no record of receiving this drug before. Ambien is a Schedule IV.

Patient pays cash for 15 tablets right now - 09/21.
This gets recorded as the first partial fill of 15 tablets.
The patient comes back 4 days later, on 09/25, asking for another 15 tablets for whatever reason (vacation, got more money, found time to go to the pharmacy now but no time later, etc.).
Another 15 tablets will now get recorded as another partial fill of 15 tablets on 09/25.
Why? The original fill entitled the patient to a full fill of 30 tablets on 09/21. The moment they hit 30 tablets or more before 10/21, you must make sure that they have no more than 7 days supply extra possible at home.

Now, here is where it gets tricky. Let's suppose that either scenario A, B, or C below occur.
A - The patient returns on 10/21 asking for a full 30 tablets. They are not early at all and can get a full 30 (recorded as the 1st full refill).
B - The patient returns on 10/11 asking for 1 to 30 tablets. They have an excess of 10 days supply at home. They are only entitled, by law, to having an extra 7 days supply or fewer at home before any more can be dispensed. Tell the patient to come back in 3 Days, on 10/14, or preferably later to avoid scrutiny.
C - The patient returns on 10/16 asking for 30 tablets. The patient should be told that they have an excess of 5 days supply at home. They are still entitled to and can get a full 30 (recorded as the 1st full refill). However, they will be held to greater scrutiny in the future and, at most, they can be 2 days early for their next fill, whether it is a partial or full fill.

Consider an odd case: On 09/21, the patient gets a partial of 10 tablets. On 09/26, they get another partial of 10 tablets. On 10/01, they get another partial of 10 tablets. A, B, or C above would still be correct.

Consider a scary case: On 09/21, the patient gets an initial partial of 10 tablets. They come back on 09/27 asking for 30 tablets. This is fine. They can get the 30 tablets as a full refill. You may argue that the patient is now getting 40 tablets within a time period where the Prescriber's Rx only intended for them to get 30 tablets. But, you are keeping count and making sure that they have no more than 7 days supply extra at home. In this case, they have an extra 4 days supply at home. Completely legal.

A borderline case: On 09/21, the patient gets a partial of 7 tablets. Then next day they come in and ask for 30 tablets. They have an excess of 6 days supply at home. This is still legally OK.

Why don't some pharmacies, even chains, not allow these practices at times?
Imagine that instead of simple old Ambien, you have to deal with Lyrica or Soma. Quantity and days supply calculations can get trickier, painful, and time-consuming.
It's easy for a us to sit here and say that pharmacies should do the math and follow what the law allows, but pharmacies must also think about what they are capable of doing properly and consistently.
Drive-thru, flu-shots, phones ringing, staffing issues, long lines, etc. and now we must carefully do and communicate the mathematics behind why a patient can or cannot get a certain days supply partial of a controlled substance. One wrong reading or calculation error and we could be accused of giving pills early or late and face professional penalties.
This is why many busy stores, or even some slow stores, may just set hard rules of "no partials on any controlled substances" or "partials as refills and no more than 5."

The middle ground that I've seen many stores follow is this: If a person gets partial fills, they are not given any more pills until the previous supplies are almost exhausted. Essentially, the patient is told to wait till the exact date of supply exhaustion or told "no more than 2 days early, no exceptions." So, scenario C, the odd case, and the scary case above would all be a NO by such pharmacies.
If patients don't like this, they can use another pharmacy.
I wonder what the legal repercussions are for such "middle ground" pharmacies.
I think these "middle ground" pharmacies have it right. Low chance of errors and most patients are fine with it.

 

[pharmalt82]

Here are some statutes from NYS law:
"Unless an earlier refilling is authorized by the prescriber, no prescription shall be refilled earlier than seven days prior to the date the previously dispensed supply would be exhausted if used in conformity with the directions for use."
Refill does not equal to partial fill.
NYS allows you to partial Schedules III to V for nearly any reason. This is not the case for Schedule II. Schedule II partials have specifically mentioned reasons for a partial.
The partialling rule for Schedules III to V:
"(j) Except as provided in sections 80.67 and 80.73 of this Part, a pharmacist may partially fill a prescription for a controlled substance provided that:
(1) each partial filling is recorded in the same manner as a refill;
(2) the total quantity dispensed does not exceed the total quantity prescribed for a 30 day period...."

Therefore, a more intricate question: What happens if you get an Rx for a 90-days-supply Schedule III to V that the patient wants to partial due to monetary or insurance reasons?
Example: Lyrica 75mg BID #180, Code C, 1 Refill.
My interpretation is that since there is no mention of partials with 90-days-supply-exemption prescriptions, I can only give up to a 30-days-supply, i.e. 60 Capsules at once. Then, 60 Capsules tomorrow if you want. Then, 60 Capsules the day after. Then, no more after until almost 90 days later.

Most pharmacies will just tell you to get a new Rx for a lower quantity or that partialing is not possible for this type of an Rx (90-day-exemption) or that we would have to lower it to 60 Capsules (30-days-supply) with 5 refills and notify/speak-with the doctor of this quantity change.

 

[wagrxm2000]

I keep it simple, I fill one day early on controls. If they pick up a partial for 15 I warn them I wont fill it again for 14 days.

 

[PharmDstudent]

All of this 7 day supply at home garbage is nonsense. Total nonsense. Why do we even waste our time?! The laws can't keep up with reality. People are highly mobile and there is a pharmacy on every corner...
There are only two things that could make a damn bit of difference and they include: if every single controlled substance is checked against a national database and no one is allowed multiple forms of identification.

 

[KidPharmD]

I keep it simple, I fill one day early on controls. If they pick up a partial for 15 I warn them I wont fill it again for 14 days.

This is unrelated to the original question, but this is why our neurology group "suggests" a handful of pharmacies for our local patients. It goes something like this... "We know that these 8 pharmacies in the area are good about not giving you too much trouble about getting your child's medications. You are of course welcome to use any pharmacy you like."

We tell patients over and over again to plan ahead and not wait till the last minute to get their medicine filled. Would you treat the seizure patient who is taking Phenobarb, Onfi, or Lyrica the same way (only 1 day early)?

 

[pharmalt82]

All of this 7 day supply at home garbage is nonsense. Total nonsense. Why do we even waste our time?! The laws can't keep up with reality. People are highly mobile and there is a pharmacy on every corner...
There are only two things that could make a damn bit of difference and they include: if every single controlled substance is checked against a national database and no one is allowed multiple forms of identification.

Whether someone uses multiple pharmacies or does doctor shopping is important BUT you are liable for the information that you have direct access and a legal requirement to check through.
NYS law says it plain and simple: 7 Days Excess Maximum Only for a refill of the same drug/dose combination.
If you can clearly see that someone is coming back for a refill on a controlled substance 10 days earlier than the supply exhaustion date, then you will be held liable for giving it to them earlier than they are legally entitled to having it.
As far as 7 days or 1 day or 2 days is concerned -- most pharmacies that I have seen are going with 2 days for any fills (partial or refill or new Schedule II Rx for the same drug/dose combo). Of course if the patient is 2 days early for 4 refills in a row, on refill number 4, you must tell them to wait another day or 2.

As far as a database is concerned: NYS's Rx Monitoring database isn't perfect and pharmacists are NOT REQUIRED to search it for any fills, but it is a useful tool nevertheless when you suspect that a patient is trying to trick the pharmacy.

 

[pharmalt82]

This is unrelated to the original question, but this is why our neurology group "suggests" a handful of pharmacies for our local patients. It goes something like this... "We know that these 8 pharmacies in the area are good about not giving you too much trouble about getting your child's medications. You are of course welcome to use any pharmacy you like."

We tell patients over and over again to plan ahead and not wait till the last minute to get their medicine filled. Would you treat the seizure patient who is taking Phenobarb, Onfi, or Lyrica the same way (only 1 day early)?

EXACTLY.
You must go on a patient-by-patient basis.
I've filled 5 days early on a phenobarbital Rx but I told the patient/guardian that the law only allows them to have an excess of 7 days worth at home and we are legally required to keep count and then they will only have 2 days or fewer of leeway upon the next refill. Upon hearing something like this, no patient has raised an issue with me.
I follow a 2-day-rule otherwise and especially if the patient accepts it without an argument because that is what I see most pharmacists and stores doing. I don't want to raise a problem for those stores by breaking "their rules."

From my experience: MOST PATIENTS, especially those new to taking controlled substances, DON'T KNOW THAT THEY ARE NOT ENTITLED TO EARLY FILLS REPEATEDLY.
Heck, most pharmacists don't even know about the 7-day rule in NYS. They just do "two-days early" because that is the way they learned it while working.

 

[Ackj]

Upon hearing something like this, no patient has raised an issue with me.......

......From my experience: MOST PATIENTS, especially those new to taking controlled substances, DON'T KNOW THAT THEY ARE NOT ENTITLED TO EARLY FILLS REPEATEDLY.

Right, and if you're using it properly and there's no abuse, you won't need it 2 days early every single month. Even if the first refill is 7 days early, you can hold them to the day for the rest of their lives, and there shouldn't be any issue, because that 7 day surplus should still exist.

The ones that crab about being held to the day are the ones who have crept in an extra day here and there, and are far beyond their 7 day surplus. They can go on about how they're leaving for vacation and just need it early this one time, but when you look back and over the past year, they should have an extra #90 tabs floating around somewhere, there is no reason for it.

NY is very restrictive on many things, but I agree with the 7 day rule. It's flexible enough to manage legitimate cases where you need an early refill, and limiting enough that abusers won't be exploiting anything.

 

[wagrxm2000]

This is unrelated to the original question, but this is why our neurology group "suggests" a handful of pharmacies for our local patients. It goes something like this... "We know that these 8 pharmacies in the area are good about not giving you too much trouble about getting your child's medications. You are of course welcome to use any pharmacy you like."

We tell patients over and over again to plan ahead and not wait till the last minute to get their medicine filled. Would you treat the seizure patient who is taking Phenobarb, Onfi, or Lyrica the same way (only 1 day early)?

I of course give exceptions but I'm not going to give ambien out two.days early like some pharmacies every month when after two times they should have 4 days worth on their hands. I just tell them if you are needing more of a control then what is prescribed you need to talk to your doctor.

 

[PharmDstudent]

Again, there are pharmacies on every corner. What makes you think that abusers won't just go somewhere else next time? I think it's quite amusing how pharmacists think they have total control. Patients can go wherever, whenever with a new script. And shoot, KidPharmD's crew will even get the word out on the street as to where they should go.

This is unrelated to the original question, but this is why our neurology group "suggests" a handful of pharmacies for our local patients. It goes something like this... "We know that these 8 pharmacies in the area are good about not giving you too much trouble about getting your child's medications. You are of course welcome to use any pharmacy you like."

 

[pharmalt82]

This is not about power. It is about liability.
You could snort the oxycodone I dispense to you. I don't care.
My rule is that you get the in-stock and in-allowance controlled substance if:
1 - The fill isn't too early (NYS's 7-Day Rule).
2 - The staff doesn't think you seem intoxicated.
3 - You have been ID'd or have a long rx history.
4 - You state Rx monitoring program record is clean.
5 - You're not coming here from 300 miles away without a good reason.

If I follow these rules, I shouldn't face legal issues. That's what this is about.
The entire purpose of this thread is to figure out exactly what the law allows us to do so that we don't get into trouble.
An example of "trouble" is a lawsuit from the patient or their family for dispensing controlled substances early and therefore causing harm to the patient.
Another example of "trouble" is the state/DEA penalizing you for not following some of the rules I mentioned above.

Pharmacists know that they don't have total control and are aware that the customer is just going to go to another pharmacy.
But, now, this other pharmacy, at least in NYS, is forced to report the dispensing to the state.
They don't have to check this state Rx record but they do have to report to it.
Most private pharmacies in NYS have begun checking this state controlled substance profile for EVERY SINGLE CONTROLLED SUBTANCE RX FILLED/REFILLED/PARTIALED.
This sounds crazy but they have more direct liability issues to face compared to the chains which only have to pay fines that are far lower than the profits they make.
Can people find ways to circumvent this system? Sure, but the hassle may not be worth it anymore, even for a $10k-street-price bottle of oxycodone IR 30mg.

Again, there are pharmacies on every corner. What makes you think that abusers won't just go somewhere else next time? I think it's quite amusing how pharmacists think they have total control. Patients can go wherever, whenever with a new script. And shoot, KidPharmD's crew will even get the word out on the street as to where they should go.

Which state or states have you seen pharmacy practice in?
It seems that you are unaware of many of these new controlled substance rx monitoring programs that many states now have.

 

[BenJammin]

Is there a DEA rule about how early you can fill a controlled substance? 26/30 days? 28/30 days? When insurance approves it?

 

[pharmalt82]

Is there a DEA rule about how early you can fill a controlled substance? 26/30 days? 28/30 days? When insurance approves it?

Ahhh, the bane of my existence: state vs federal law.
Federal law seems vague at best.
I am trying to find the fine print.
The closest I got is this: http://www.deadiversion.usdoj.gov/21cfr/21usc/829.htm

 

[PharmDstudent]

This is not about power. It is about liability.
You could snort the oxycodone I dispense to you. I don't care.
My rule is that you get the in-stock and in-allowance controlled substance if:
1 - The fill isn't too early (NYS's 7-Day Rule).
2 - The staff doesn't think you seem intoxicated.
3 - You have been ID'd or have a long rx history.
4 - You state Rx monitoring program record is clean.
5 - You're not coming here from 300 miles away without a good reason.

If I follow these rules, I shouldn't face legal issues. That's what this is about.
The entire purpose of this thread is to figure out exactly what the law allows us to do so that we don't get into trouble.
An example of "trouble" is a lawsuit from the patient or their family for dispensing controlled substances early and therefore causing harm to the patient.
Another example of "trouble" is the state/DEA penalizing you for not following some of the rules I mentioned above.

Pharmacists know that they don't have total control and are aware that the customer is just going to go to another pharmacy.
But, now, this other pharmacy, at least in NYS, is forced to report the dispensing to the state.
They don't have to check this state Rx record but they do have to report to it.
Most private pharmacies in NYS have begun checking this state controlled substance profile for EVERY SINGLE CONTROLLED SUBTANCE RX FILLED/REFILLED/PARTIALED.
This sounds crazy but they have more direct liability issues to face compared to the chains which only have to pay fines that are far lower than the profits they make.
Can people find ways to circumvent this system? Sure, but the hassle may not be worth it anymore, even for a $10k-street-price bottle of oxycodone IR 30mg.

So the truth comes out. You are worried about getting in trouble. Of course. I should have known. I just hope you don't wet your pants whenever another pharmacist at a different store reviews a controlled script from your store. Heaven forbid they let something slide. I mean, the DEA, BOP, FDA, CDC, ABC, DEF, GHI, JKL, MNO, PQR, STU, VWX, or YZ could be watching... right... now... as we speak!

Do you understand who actually gets in trouble? Do you realize who gets sued by family members?

The most important part of your job is to get the right medicine to the right patient. That's the easiest way to avoid a lawsuit. Second, playing stand off games with patients just makes them and everyone else despise you.

I'm not advocating that you fill controlled substances on a whim, but I think it's your job as a concerned pharmacist to find out why the 7 day law was passed. If other pharmacists don't even know about the law, then why is it such a big deal to you? (I mean, is this not a valid and obvious question?) What does the board want to prevent with that law and what can you avoid so that you don't make the same mistake as someone else? In other words, you can either follow an arbitrary law or rule and make yourself crazy over it or you can simply find out what not to do. Enactments are typically reactive instead of proactive.

Which state or states have you seen pharmacy practice in? It seems that you are unaware of many of these new controlled substance rx monitoring programs that many states now have.

Nope. We've had monitoring systems for quite a while now, and like any other tool, you have to know when to use it.

Again, unless a database is getting checked each and every time, laws that limit patients to a 7 day supply are impractical and antiquated. Why not limit it to 6 days or 5 days or 4 days or 3 days or 2 days or 1 day?


ETA: Oh, and doesn't the law specifically state that the 7 day rule concerns the last fill and not what adds up to what once you start keeping tabs or backtracking over the entire time you've known a patient? "3. Unless an earlier refilling is authorized by the prescriber, no prescription for a controlled substance may be refilled earlier than seven days prior to the date the previously dispensed supply would be exhausted if used in conformity with the directions for use." Hence, if the patient has gone elsewhere and you don't look them up in the monitoring system whenever they leave there and come to you, you won't know the difference!

 

[genesis09]

Is there a DEA rule about how early you can fill a controlled substance? 26/30 days? 28/30 days? When insurance approves it?

The DEA is silent on the issue. All it says is more or less is to use your judgment. If your state has a law about it, you should follow it. Most allow in the neighborhood of 2-3 days early.

 

[pharmalt82]

So the truth comes out. You are worried about getting in trouble.

I wasn't trying to hide this fact. Am I worried about getting in trouble? Slightly. But, that's only because I don't understand some aspects of the law.
I don't write the law. It doesn't keep up with reality sometimes. Nevertheless, you can be certain that its words will be used against you in a court of law.

Of course. I should have known. I just hope you don't wet your pants whenever another pharmacist at a different store reviews a controlled script from your store. Heaven forbid they let something slide. I mean, the DEA, BOP, FDA, CDC, ABC, DEF, GHI, JKL, MNO, PQR, STU, VWX, or YZ could be watching... right... now... as we speak!

A little-known fact about company-policies at major chains that allow RPhs to verify controlled substance Rxs for other stores: the pharmacist performing final drug verification/review/check is held to the greatest level-of-responsibility. Nevertheless, the other RPh who verified the Rx at the other store does NOT get a free pass but is held to a lower level of liability, at least in the company. So, if an RPh lets an extremely early fill slide when reviewing an Rx from your store, you may both be in trouble.
How would a NYS court distribute liability and penalties in such a technologically distributed scenario? I don't know. Maybe someone can find a case for us to learn from.

Do you understand who actually gets in trouble? Do you realize who gets sued by family members?

Not exactly, please give me examples. My assumption is that pharmacists who make errors in Rx information entry, DUR-resolution, and or dispensing may get into trouble with their employer or the law. My assumption is also that pharmacists who fill controlled substances too early will get into trouble with the law.
My goal is to figure out how exactly lenient I can or cannot be.

The most important part of your job is to get the right medicine to the right patient. That's the easiest way to avoid a lawsuit. Second, playing stand off games with patients just makes them and everyone else despise you.

All these years, I didn't realize this was the job of a pharmacist. Thank you for enlightening me.
What is odd is that I have never, in all these years, seen even the strictest pharmacist get into a serious stand-off with a patient over an early fill of a controlled substance.

I'm not advocating that you fill controlled substances on a whim, but I think it's your job as a concerned pharmacist to find out why the 7 day law was passed. If other pharmacists don't even know about the law, then why is it such a big deal to you? (I mean, is this not a valid and obvious question?) What does the board want to prevent with that law and what can you avoid so that you don't make the same mistake as someone else? In other words, you can either follow an arbitrary law or rule and make yourself crazy over it or you can simply find out what not to do. Enactments are typically reactive instead of proactive.

Other pharmacists can be wrong. I just want to try to figure out what the "truth" is. My current rule is 2-days-early-only for any refills/partials or same drug Rxs if there isn't a history of odd early fills. If something seems odd, I calculate the excess supply you may have at home as per your previous fills and hold you to the 7-day-rule.
Honestly, I don't care about why the law was passed. I can guess that it is to prevent people from abusing controlled substances. Either way, I am subject to the law. Maybe pharmacists can lobby NYS to clarify or change the law as we see fit.

Again, unless a database is getting checked each and every time, laws that limit patients to a 7 day supply are impractical and antiquated. Why not limit it to 6 days or 5 days or 4 days or 3 days or 2 days or 1 day?

So, a pharmacist who clearly sees that a patient is coming in 10 days early for a refill on a schedule IV controlled substance just by viewing their own database/profile, should ignore the 7-day-rule because his opinion says that the law is stupid because someone could be using multiple pharmacies?
You are held liable for what you know about this patient's history. No one is going to penalize for not knowing that someone is skillfully doctor and pharmacy shopping and selling or abusing the drugs dispensed to them. But, if you can see the record of controlled substance fills by a patient via your company's own database and if this record clearly shows repeated early fills, then you should and will be held liable, if you keep dispensing early.

Newsflash: No one cares about our opinions of the law. When push comes to shove, the letter of the law will be used against us in court, even 5 years down the line.
Most of the major chains now have policies on the books (I know this via friends) that require that you must query your state database for certain, but not all, controlled substance Rxs. NYS law does not require pharmacies to check the state database, only to report to it. Therefore, if someone is doctor and pharmacy shopping on a controlled substance that isn't on my company's "watch list," then I don't care.

My only issue is to figure out what I will be held liable for based on what I know: company's medication profile and occasionally, a check of the state's database.

ETA: Oh, and doesn't the law specifically state that the 7 day rule concerns the last fill and not what adds up to what once you start keeping tabs or backtracking over the entire time you've known a patient? "3. Unless an earlier refilling is authorized by the prescriber, no prescription for a controlled substance may be refilled earlier than seven days prior to the date the previously dispensed supply would be exhausted if used in conformity with the directions for use." Hence, if the patient has gone elsewhere and you don't look them up in the monitoring system whenever they leave there and come to you, you won't know the difference!

Excellent point. After reading enough of the law, it is this type of ambiguity that irritates me. For now, I will assume "the previously dispensed supply" includes ALL previous fills of that same drug/dosage that I am to be aware of via my company's database and occasionally, the state's database that my company may require me to check for certain drugs.

 

[zelman]

ETA: Oh, and doesn't the law specifically state that the 7 day rule concerns the last fill and not what adds up to what once you start keeping tabs or backtracking over the entire time you've known a patient? "3. Unless an earlier refilling is authorized by the prescriber, no prescription for a controlled substance may be refilled earlier than seven days prior to the date the previously dispensed supply would be exhausted if used in conformity with the directions for use." Hence, if the patient has gone elsewhere and you don't look them up in the monitoring system whenever they leave there and come to you, you won't know the difference!

If you get 30 tabs of a QD med on day #x and 30 more on day #(x+25), the second supply should not be started for 5 more days in conformity with the directions for use. While you are technically looking specifically at that prescription, the previous prescription dictates the therapy start date, and thus the end date (and 7 day early date).

 

[PharmDstudent]

So if John Doe filled the script early previously, and when I say early I mean like five times over and over again for whatever reason, then you filled it correctly based on the previous supply that was dispensed, should pharmacist number three then hold off after you because John Doe filled it early five times before you even touched it?
My point is that you have to use your common sense to draw a line between the past and the here and now. You can't fix what John Doe did, but if the patient is out of medication, then you need to have a discussion with the patient to start a new precedent. Playing tit for tat games will just waste you time, get people pissed off, and open you up to more scrutiny once the drama ensues.

But what do I know? I've never been called into court. My old pharmacy manager has though. Perhaps she should have spent more of her time verifying prescriptions correctly than playing tit for tat with pain management patients?!

 

[Estrace]

Are you even a pharmacist? You can play with your license when you get one.

 

[BidingMyTime]

So if John Doe filled the script early previously, and when I say early I mean like five times over and over again for whatever reason, then you filled it correctly based on the previous supply that was dispensed, should pharmacist number three then hold off after you because John Doe filled it early five times before you even touched it?
My point is that you have to use your common sense to draw a line between the past and the here and now. You can't fix what John Doe did, but if the patient is out of medication, then you need to have a discussion with the patient to start a new precedent. Playing tit for tat games will just waste you time, get people pissed off, and open you up to more scrutiny once the drama ensues.

In this situation, you call the physician & discuss the issue with him, if he authorizes the early refill (or gives you a new RX if required), then you document it & fill it (from my reading of NY law, earlier fills than 7 days are allowed if the doctor OK's it.) The patient gets the medication they need, the law is fulfilled, and everyone is happy. If the doctor does not authorize it, or says the patient needs an appt first to discuss their medication usage, then document it and let the patient know. If the patient doesn't like that answer, well they can discuss it with their doctor.

I really don't get pharmacists who try to think up excuses not to follow the law. I can understand the math is a pain in the rear to have to deal with during a busy day, but following this law really isn't that hard.

 

[pharmalt82]

Here is something that happened about 2 months ago.
I was floating and it was my third time at this store.

A patient came in with a schedule II Rx for an EXACT 15-days-supply (based on the maximum daily dose). I looked at the patient's profile which reaches back nearly 4 years. Her state's Rx monitoring record is clean, and she only seems to have used our pharmacy.
Here's what I found: she has been getting this same exact Rx for the past 3 years: 15 days supply, same drug, same sig, same strength, same frequency, same doctor, etc.
The Rx is legitimate, typewritten, signed, and identical for the past 3 years (except for the date and serial number, of course).

What's the catch?
She has been filling this Rx at this pharmacy EXACTLY every 14 days, like clockwork, for the past 3 years.
This essentially means that she's got 30 to 90 days-supply worth extra over the course of the past 3 years.

What did I do?
I called the doctor and asked him if he was okay with this. I told him I would fill it if I could document the fact that he was aware of these constant 1-day-early fillings for the past 3 years and if he was still okay with her getting this Rx right now. I also asked him if he wanted me to reset the excess-days-supply-clock for her by documenting that as well to make it easier for her in the future.
Lo and behold, the doctor was instantly bewildered. Here's a summary of what he said: "Wait. No way. Tell her to come back to me tomorrow, actually today if she can..etc. I have to talk to her. Are you able to fax me your record of the fills?"
My response: "Check the state's Rx monitoring website and extrapolate back. It's an identical story for the past 3 years."
His response: "Okay. But, can you VOID this prescription I issued to her yesterday? I'll also have my secretary call her and tell her to come in again just in case she doesn't respond to your request to come and see me again."
My response: "I don't think I have the authority to VOID this prescription. I can return it to her and make a note in our computer about this so that no one here fills it without seeing the note."
Doctor's final response: "Fair enough."

Obviously, the patient was angry. I foresaw and received statements about how I have no right to call her doctor..blah..blah..blah..
I gave her the Rx back and told her to contact her doctor's office.

This incident scared me. I saw the other staff RPhs in this store as being competent. Not anymore.

The stupidest thing is the fact that NYS has just created the monitoring record but, even without it, the doctors know the rules they have to follow but apparently can't, don't, and or won't.

After working for a while, I have found that this type of BS is commonplace.
RPhs think "1-day-early only" or "2-days-early-only" and they are good to go. NO. That isn't the only thing.
You can be 1-day-early or 2-days-early for every fill over the past year but that won't make it legal/right. But, plenty of RPhs think that this is fine. It's not.

If you're 1 or 2 days early each damn time, you are stockpiling or abusing or selling and that's fine with me as long as I have your doctor on-the-record as being okay with each and every early-fill you demand after a whole slew of early fills.
Something tells me you're going to go somewhere else though...

 

[owlegrad]

I'm always confused when doctors don't realize their patient's are filling early don't they know how many prescriptions they've written for the control in the last year?

 

[PharmDstudent]

Here is something that happened about 2 months ago.
I was floating and it was my third time at this store.

A patient came in with a schedule II Rx for an EXACT 15-days-supply (based on the maximum daily dose). I looked at the patient's profile which reaches back nearly 4 years. Her state's Rx monitoring record is clean, and she only seems to have used our pharmacy.
Here's what I found: she has been getting this same exact Rx for the past 3 years: 15 days supply, same drug, same sig, same strength, same frequency, same doctor, etc.
The Rx is legitimate, typewritten, signed, and identical for the past 3 years (except for the date and serial number, of course).

What's the catch?
She has been filling this Rx at this pharmacy EXACTLY every 14 days, like clockwork, for the past 3 years.
This essentially means that she's got 30 to 90 days-supply worth extra over the course of the past 3 years.

What did I do?
I called the doctor and asked him if he was okay with this. I told him I would fill it if I could document the fact that he was aware of these constant 1-day-early fillings for the past 3 years and if he was still okay with her getting this Rx right now. I also asked him if he wanted me to reset the excess-days-supply-clock for her by documenting that as well to make it easier for her in the future.
Lo and behold, the doctor was instantly bewildered. Here's a summary of what he said: "Wait. No way. Tell her to come back to me tomorrow, actually today if she can..etc. I have to talk to her. Are you able to fax me your record of the fills?"
My response: "Check the state's Rx monitoring website and extrapolate back. It's an identical story for the past 3 years."
His response: "Okay. But, can you VOID this prescription I issued to her yesterday? I'll also have my secretary call her and tell her to come in again just in case she doesn't respond to your request to come and see me again."
My response: "I don't think I have the authority to VOID this prescription. I can return it to her and make a note in our computer about this so that no one here fills it without seeing the note."
Doctor's final response: "Fair enough."

Obviously, the patient was angry. I foresaw and received statements about how I have no right to call her doctor..blah..blah..blah..
I gave her the Rx back and told her to contact her doctor's office.

This incident scared me. I saw the other staff RPhs in this store as being competent. Not anymore.

The stupidest thing is the fact that NYS has just created the monitoring record but, even without it, the doctors know the rules they have to follow but apparently can't, don't, and or won't.

After working for a while, I have found that this type of BS is commonplace.
RPhs think "1-day-early only" or "2-days-early-only" and they are good to go. NO. That isn't the only thing.
You can be 1-day-early or 2-days-early for every fill over the past year but that won't make it legal/right. But, plenty of RPhs think that this is fine. It's not.

If you're 1 or 2 days early each damn time, you are stockpiling or abusing or selling and that's fine with me as long as I have your doctor on-the-record as being okay with each and every early-fill you demand after a whole slew of early fills.
Something tells me you're going to go somewhere else though...

So in this case, I would have called the patient out on it as politely as possible and said no to an early refill. If the patient rejected my decision or escalated the situation, then I would have contacted the doctor.

If the patient is out of medication then playing catch to recoup early refills just makes the situation worse. You can't make up for lost time or the incompetence of other people. Retail pharmacy is like an oncoming river that you have to keep back in order to save yourself. You can't change what others do, so whenever they do it again next time, which will happen, you will find yourself in the same position again cleaning up another person's mess again.

After seeing all of this paranoia unfold, I'm contemplating calling the NY BOP myself to get their stance on the law because a few of you are worrying me

 

[pharmalt82]

I expect nothing but ambiguous statements from NYS BOP and BNE.
I would love to see one of us bring up the scenarios I brought up about partials on schedules III-V.
They'll probably never respond "on the record."
When time permits, we should compile a list of odd but realistic scenarios and ask them what the "correct" answer is.

Here's something that scared me when I was just starting out as a pharmacist:
I was new to all the screens that only the pharmacist had access to.
When an Rx claim is settled, the pharmacist is able to view the extra messages that an insurance company responds with.
Most chain pharmacy programs ask you to "override" or "confirm" these messages. Private pharmacies just let you view these messages.
It means that the insurance has just paid for the drug but has something to tell you.
These messages may include the fact that the same or another antibiotic has been filled at another pharmacy a few days ago. No big deal.

But, on controlled substances, insurances may tell you that the patient has filled x# of Rxs for in the past 90 days.
This x# count isn't specific and seems to include all controlled substances filled in the past 90 days.
I spoke to other, more experienced, pharmacists and all of them told me to override/ignore/confirm this specific type of message.
I even agreed because some patients are on many different controlled substances at the same time and this x# count may therefore reach as high as 20 or more.
Nevertheless, this x# count includes controlled substance Rxs filled at your pharmacy and OTHER PHARMACIES.
I began merrily overriding these message based on a quick estimation of the number of controlled substances a patient is filling at my location via a quick glance at the medication profile.

One fine day, I was processing a refillable schedule III to V that I never check the state's Rx monitoring record for.
The claim goes through but the message it wanted me to override was "14 Rxs filled in the past 90 days."
I look at the profile and, apart from some antibiotics, he only gets this one refillable schedule III to V drug from us written by the same doctor.
He comes in, on time, for his refills every 30 days. So, there was no way the count should have reached 14.
So, I looked him up on the state's Rx monitoring website hoping that he gets different controlled substances from other pharmacies, therefore mostly clearing him of any wrongdoing.
What did I find? 3 other chain pharmacies, all with active Rxs written by the same doctor for the same drug/dosage/days-supply.
The doctor seemed to be writing her a new Rx upon every appointment but placing a different number of refills on it every time.
The script is typewritten also. No sign of tampering. Even without refills, the time period between when new Rxs were issued was too short. No alerts about stolen pads.
Guess what? The insurance is paying for all these claims at these other pharmacies and previous pharmacists at my location and at these chains have been ignoring these messages forever. So much for insurance companies being stingy.

You can fill in the rest of the story. I didn't refill the Rx and alerted the staff. The patient acted dumbfounded. No arguments though.

What am I to assume?

I'm always confused when doctors don't realize their patient's are filling early don't they know how many prescriptions they've written for the control in the last year?

In my case, my assumption is that this doctor is either negligent or corrupt. I don't waste my energy calling and reporting these things. I just don't refill.
This type of story has become VERY common as well. It doesn't even bother me anymore.

But, a more important question: What if I had ignored that message?
Would I have been held liable by the patient's family or by the DEA/BOP/BNE?
What about all the other pharmacists who just ignored the message?

What if the x# count was 4 instead of 3 and he had just filled the same Rx at another pharmacy a few days ago?
I wouldn't have checked the state's records. He would have gotten away with it. Would I still be liable? I don't think I should be scrutinized at that point. But, if the count says 14...screw that, I'm double-checking.

 

[swatchgirl]

He's not asking what you all think he's asking.

The portion of the manual addressing partial fills refers to CIII, CIV, and CV and discusses a 6 month limit.

The portion of the manual addressing refills only refers to CIII and CIV.

He is asking if CV has a 6 month limit as the manual doesn't specify under the refills section.

The manual doesn't specific, so it is state-specific.

 

[Sine Cura]

In case anyone studying for a state MPJE is confused, partial fill regulations shouldn't be confused with refill limit regulations or day supply limitations.

Like with CII partial fills for LTCF or terminal illness not exceeding 60 days from the date of issue. Federal regulation does not explicitly limit CII day supply at all (that whole "legitimate medical purpose" thing limits day supply in practice) and many states don't limit day supply either on CIIs.

Nor does federal regulation specify refill limits on schedule V or expiration date (some states do limit schedule V to six months, like California where all controlled substances are not valid after six months from the date of issue, whereas Arizona limits CV to one year like all other non-controlled prescriptions).

 

[ilyac]

Partial fill for CII is clear. No refill on CII at all keep that in mind. There is a state where the partial fill can done within 50 days.
I just passed MS, MO, AZ and LA within a 30 days from 02/09/2016 some of them I studied only for two days


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