Is it okay to fill a CII 9 days early when the doctor has changed the sig?

swatchgirl

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This kid is on the Quillivant XR 5mg/ml oral suspension, last month the rx was written for 15 ml q day, disp. three 180ml bottles. This month, the rx was written for the same suspension, but for 20 ml q day, disp. four bottles. Insurance obviously had issues with the dosage, but that's not the only issue. The kid's dad wants the script filled 9 days earlier than due date. He says "I know it is okay to fill, because the doctor has changed the directions from 15 ml to 20 ml, so it's a new prescription, and not a refill".

Seriously? He's obviously not concerned with his 11-year old developing tolerance to the drug and possibly be at risk for overdosing. I told him I needed a PA from the doctor to override the insurance block, but I am still not sure filling the script 9 days ahead of schedule is okay. Could someone please help clarify?

I encountered a similar issue with a tramadol script last week where the directions changed and the dosage went up from the previous month's fill, patient wanted the tramadol filled early due to the change, claiming that it is now no longer a refill, but a new script.
 

lord999

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That's a toughy. I always decide these without insurance as a consideration as I consider it to be false-frend information to me in these circumstances (unless it's telling me that patient has filled elsewhere that I didn't know about it).

My answer:
The ideal answer is, yes, bring your old bottle in and I'll deal with the destruction, else, you can save some money and finish out the bottle with your new sig, and I'll have a fresh suspension prepared for the day it ends. The realistic answer is that I'd probably (as in how I say it may change but not what I say) say that it would be in their best interests to finish the old bottle as it is the same concentration just higher dosing, but I'm willing to accept the last part of the old script back for destruction to issue this new dose early (If objected on why they can't keep both, cite the USP stability rules for this drug, and it'll go bad sooner and that hurts everyone.) I am willing to remake the suspension to be as long-dated as possible, but would not be possible and stable with the old and the new prescription bottles together without one of them going bad.
 
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owlegrad

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Way over complicating it. Just figure out how long the old bottle would last with the new instructions and that's the due date. Unless I'm misunderstanding your question in which case I apologize.

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Momus

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Count how fast are they using the old stock based on the new dose. Only dispense new rx if the first fill run out based on the new dose. That's what I always do. Simple..

Based on your case, it's 540/20 = 27 days supply. You can dispense it again 27 days later based on new direction - maybe 1-2 days early for the new rx he presented. I'd write on the rx the date it can be filled and tell him it's too soon, explain it, if he argues, I tell him he can take his rx back and find another pharmacy. Keep in mind you already kill his script to be filled later since you write on it, most likely no one in town will fill it early also, he will probably come back to you.
 

waiter

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Way over complicating it. Just figure out how long the old bottle would last with the new instructions and that's the due date. Unless I'm misunderstanding your question in which case I apologize.

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I agree.
Would also not accept the old C-II bottle for disposal unless registered with the DEA as an authorized take-back site.
 

FarmD711

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I agree.
Would also not accept the old C-II bottle for disposal unless registered with the DEA as an authorized take-back site.
This. People telling you to take back CIIs are giving bad advice.

Also 3 180 ml bottles is a 36 day supply at the 15 ml dosing. Also not ok. You can't dispense greater than a 30 day supply.

Also 4 180 ml bottles would be a 36 day supply at 20 ml dosing. Also not ok.


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Lnsean

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This kid is on the Quillivant XR 5mg/ml oral suspension, last month the rx was written for 15 ml q day, disp. three 180ml bottles. This month, the rx was written for the same suspension, but for 20 ml q day, disp. four bottles. Insurance obviously had issues with the dosage, but that's not the only issue. The kid's dad wants the script filled 9 days earlier than due date. He says "I know it is okay to fill, because the doctor has changed the directions from 15 ml to 20 ml, so it's a new prescription, and not a refill".

Seriously? He's obviously not concerned with his 11-year old developing tolerance to the drug and possibly be at risk for overdosing. I told him I needed a PA from the doctor to override the insurance block, but I am still not sure filling the script 9 days ahead of schedule is okay. Could someone please help clarify?

I encountered a similar issue with a tramadol script last week where the directions changed and the dosage went up from the previous month's fill, patient wanted the tramadol filled early due to the change, claiming that it is now no longer a refill, but a new script.
what owl said....you're making this way too complicated than it has to be.
 

doublehh03

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Way over complicating it. Just figure out how long the old bottle would last with the new instructions and that's the due date. Unless I'm misunderstanding your question in which case I apologize.

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+1. Pretty much how I handle it. If it's a new sig or new dose, then everything is adjusted.
 

zelman

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I agree with the thread consensus. Just posting to note that "it's not a refill because the SIG changed" is a stupid argument. If I got a dozen morphine prescriptions from 12 different doctors, you shouldn't fill them all in one day since they aren't "refills" as they're different prescribers.
 

ldiot

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This kid is on the Quillivant XR 5mg/ml oral suspension, last month the rx was written for 15 ml q day, disp. three 180ml bottles. This month, the rx was written for the same suspension, but for 20 ml q day, disp. four bottles. Insurance obviously had issues with the dosage, but that's not the only issue. The kid's dad wants the script filled 9 days earlier than due date. He says "I know it is okay to fill, because the doctor has changed the directions from 15 ml to 20 ml, so it's a new prescription, and not a refill".

Seriously? He's obviously not concerned with his 11-year old developing tolerance to the drug and possibly be at risk for overdosing. I told him I needed a PA from the doctor to override the insurance block, but I am still not sure filling the script 9 days ahead of schedule is okay. Could someone please help clarify?

I encountered a similar issue with a tramadol script last week where the directions changed and the dosage went up from the previous month's fill, patient wanted the tramadol filled early due to the change, claiming that it is now no longer a refill, but a new script.
Calculate how much of the medication the patient should have left on the day of the dose change, then calculate how long that remaining medication should last them at the new dose and make that the fill date. What the patient says about it not being a refill is bogus and they are just trying to pressure you into filling it. It's a continuation of therapy at an adjusted dose, not a new therapy. All that being said 100mg/day for an 11 year old is ridiculous and I'd probably turn it away, especially considering he's trying to get it 9 days early.

Funny how nobody is ever trying to get their kid's singulair or multivitamin 9 days early.
 
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Dr Wario

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. All that being said 100mg/day for an 11 year old is ridiculous and I'd probably turn it away, especially considering he's trying to get it 9 days early.

Funny how nobody is ever trying to get their kid's singulair or multivitamin 9 days early.
This is the only part of this thread that makes sense, no way in hell would I fill that.
 

Apotheker2015

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This kid is on the Quillivant XR 5mg/ml oral suspension, last month the rx was written for 15 ml q day, disp. three 180ml bottles. This month, the rx was written for the same suspension, but for 20 ml q day, disp. four bottles. Insurance obviously had issues with the dosage, but that's not the only issue. The kid's dad wants the script filled 9 days earlier than due date. He says "I know it is okay to fill, because the doctor has changed the directions from 15 ml to 20 ml, so it's a new prescription, and not a refill".

Seriously? He's obviously not concerned with his 11-year old developing tolerance to the drug and possibly be at risk for overdosing. I told him I needed a PA from the doctor to override the insurance block, but I am still not sure filling the script 9 days ahead of schedule is okay. Could someone please help clarify?

I encountered a similar issue with a tramadol script last week where the directions changed and the dosage went up from the previous month's fill, patient wanted the tramadol filled early due to the change, claiming that it is now no longer a refill, but a new script.
Swatchgirl,

I would not have filled the first script to begin with. The max dose is 60mg/day. To me, it sounds like daddy got a taste of it and liked it. Why else would he insist on getting it 9 days early? In He probably asked the physician for a dose increase to accommodate his dose also. In fact, I would not be surprised if he did not have any left at home. A daily dose of 100 mg is almost twice as much as the max dose studied. I would not verify that. 75 mg/day is way more than enough. Dose is supposed to be increased by 10 mg to 20 mg per week. You're the last check point to ensure that dose is safe. I wouldn't bless it.

Best,

Apotheker2015
 

6GodPharm

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Do you guys use the date written on the new prescription to calculate how much they have left? What if the patient started using their old prescription as the new one earlier than the date on the new prescription? Do you just tell the patient tough luck?
 

Apotheker2015

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Do you guys use the date written on the new prescription to calculate how much they have left? What if the patient started using their old prescription as the new one earlier than the date on the new prescription? Do you just tell the patient tough luck?
6GodPharm,

I probably wouldn't say "tough luck". I would probably use the date the prescription with the new sig was written. Sometimes prescribers do tell a patient over the phone to go ahead and start using the drug with the new instructions before an appointment is available or way before someone is able to go pick up the script.
As I mentioned, I would have had an issue with the initial 75 mg/day dose. But in the case of a patient whose dose is increased within the maximum recommended daily dose, I would definitely contact the prescriber on this one and ask when the patient was supposed to start the new dig. Remember that all a patient can clarify on a C-II prescription to a pharmacist is the patient's address. That's it.
 
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swatchgirl

swatchgirl

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Swatchgirl,

I would not have filled the first script to begin with. The max dose is 60mg/day. To me, it sounds like daddy got a taste of it and liked it. Why else would he insist on getting it 9 days early? In He probably asked the physician for a dose increase to accommodate his dose also. In fact, I would not be surprised if he did not have any left at home. A daily dose of 100 mg is almost twice as much as the max dose studied. I would not verify that. 75 mg/day is way more than enough. Dose is supposed to be increased by 10 mg to 20 mg per week. You're the last check point to ensure that dose is safe. I wouldn't bless it.

Best,

Apotheker2015
The dad did sound strange on the phone, he put on a triumphant air as he was giving me the "it's a new script" excuse, like he knows exactly what he's doing and he has done it before. I was tempted to almost say to him "excuse you sir but are you the pharmacist or am I the pharmacist?" The dad sounded young, someone in his mid to late 30's, definitely still young and robust enough to experiment with ADHD medications for himself. I had a bad feeling about him just from talking to him over the phone, and the way he ended our conversation.

Thanks Apotheker2015. I'm gonna trust my instinct on this one and take your advice. I also thought the dosage had exceeded the 60 mg/day recommendation, and that 75 mg/day was already pushing it. Whatever the prescribing doctor has in mind for the kid (and/or the dad), I don't want to be a part of it. Now that it has increased to 100 mg/day, I'm going to draw the line and tell him his son's old bottles should have at least 195 ml left, which is enough for a 9 day-supply at the new dose. So he's going to have to wait for at least a week to have the new script filled, or better yet, take it somewhere else.
 
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swatchgirl

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This. People telling you to take back CIIs are giving bad advice.

Also 3 180 ml bottles is a 36 day supply at the 15 ml dosing. Also not ok. You can't dispense greater than a 30 day supply.

Also 4 180 ml bottles would be a 36 day supply at 20 ml dosing. Also not ok.


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I may be wrong but I almost feel like my pharmacy manager is condoning it, he dispensed the first script and the scripts before it. He keeps on ordering the 180 ml bottles, rather than the smaller sizes, so the 180 ml is the only size we currently have in stock. He keeps these bottles on hand every week just for this "family", he said, as they are his "regular customers". I'll ask him if we could start ordering some 120 ml bottles and see his reaction.
 

Old Timer

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Way over complicating it. Just figure out how long the old bottle would last with the new instructions and that's the due date. Unless I'm misunderstanding your question in which case I apologize.

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This is the only right answer. Anything else is writing or speaking to hear yourself talk.
 

Old Timer

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Also 3 180 ml bottles is a 36 day supply at the 15 ml dosing. Also not ok. You can't dispense greater than a 30 day supply.
Please tell me where you pulled this from. There is no limit to the amount in DS of controlled substances you can order per Federal Law. Your state law may be different. But Federally, you can give them 900 days....



TheSchedule II controlled substances require a written prescription which must be manually signed by the practitioner or an electronic prescription that meets all DEA requirements for electronic prescriptions for controlled substances. There is no federal time limit within which a schedule II prescription must be filled after being signed by the practitioner. However, the pharmacist must determine that the prescription is still needed by the patient. While some states and many insurance carriers limit the quantity of controlled substances dispensed to a 30-day supply, there are no express federal limits with respect to the quantities of drugs dispensed via a prescription. However, the amount dispensed must be consistent with the requirement that a prescription for a controlled substance be issued only for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. For a schedule II controlled substance, an oral order is only permitted in an emergency situationre is no limit to the amount in DS of controlled substances you can order per Federal Law. Your state law may be different. But Federally, you can give them 900 days....

 
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Dr Wario

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The OP made the mistake of asking this reasonable question in the context of an absolutely ridiculous situation. As others have stated, assuming dosing is reasonable, the increase begins on the written date of the new rx and you calculate the due date from there (unless the prescriber clarifies that it should have started at an earlier date).

I cannot tell you how many times junkies bring in "dose increases" to me and expect that just because it is an increase they can have it whenever they wish. One common example I see are the pain management people who have a sudden surgery/accident and increase their pain medication from tid to 1 q 4 (different doctor) but had a 30 day supply filled 5 days ago and think they should get the second now.
 
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Rukn

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Way over complicating it. Just figure out how long the old bottle would last with the new instructions and that's the due date. Unless I'm misunderstanding your question in which case I apologize.

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Yeah i thought this was what everybody did
 

ldiot

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Do you guys use the date written on the new prescription to calculate how much they have left? What if the patient started using their old prescription as the new one earlier than the date on the new prescription? Do you just tell the patient tough luck?
I ask them when the dose change was okayed by the doctor before they even get the hint that I'm going to calculate it out. "Okay so the doctor okayed the new dosage 2 days ago?" basing this on the date of the script. If they claim the doctor verbally told them to take more prior to the date of the new script I call to get the okay... most doctors okay it without even considering how much medication the patient should have left so if there is a significant discrepancy I try to get them to tell me the date that they verbally told the patient that it's okay to take more, document that date, and calculate it based on that.
 

maria1oh

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30 days could also apply for insurance. If you are dispensing actual 36 day supply to insurance only allowing 30 days.

I have seen some stores break the bottles of quillivant to dispense the exact amount. Others refuse to break them because they expire 4 months after reconstitution.
 

Old Timer

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The OP made the mistake of asking this reasonable question in the context of an absolutely ridiculous situation. As others have stated, assuming dosing is reasonable, the increase begins on the written date of the new rx and you calculate the due date from there (unless the prescriber clarifies that it should have started at an earlier date).

I cannot tell you how many times junkies bring in "dose increases" to me and expect that just because it is an increase they can have it whenever they wish. One common example I see are the pain management people who have a sudden surgery/accident and increase their pain medication from tid to 1 q 4 (different doctor) but had a 30 day supply filled 5 days ago and think they should get the second now.
Why. This is a moronic assumption. You should never assume. Especially with a C-II. The patient may be instructed by the prescriber to increase the dose verbally and then provide a new rx days or weeks later especially if they already have a supply in hand.

In your example someone goes to pain management on 8/1 and gets 90 doses at tid. Now they come with a new rx for q4, They would still have to wait 15 days and for a call to the pain management doc to let him know what ios going on as the patient probably violated their contract with pain management. So no, they couldn't get the new rx after getting 90 five days ago.
 

Apotheker2015

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Please tell me where you pulled this from. There is no limit to the amount in DS of controlled substances you can order per Federal Law. Your state law may be different. But Federally, you can give them 900 days....



TheSchedule II controlled substances require a written prescription which must be manually signed by the practitioner or an electronic prescription that meets all DEA requirements for electronic prescriptions for controlled substances. There is no federal time limit within which a schedule II prescription must be filled after being signed by the practitioner. However, the pharmacist must determine that the prescription is still needed by the patient. While some states and many insurance carriers limit the quantity of controlled substances dispensed to a 30-day supply, there are no express federal limits with respect to the quantities of drugs dispensed via a prescription. However, the amount dispensed must be consistent with the requirement that a prescription for a controlled substance be issued only for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. For a schedule II controlled substance, an oral order is only permitted in an emergency situationre is no limit to the amount in DS of controlled substances you can order per Federal Law. Your state law may be different. But Federally, you can give them 900 days....
I am pretty sure that FarmD711 meant that you can't dispense a 36-day supply and bill the insurance for a 30 day supply. Aside from that, sure, there is no federal limit on when a prescription must be filled or at least presented to the pharmacy and no limit on the day supply that can be dispensed. However, there are couple of things that do draw a dotted line around the issue. The DEA allows a practitioner to issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a schedule II controlled substance. So that's one dotted line. The other one is insurance. No insurance plan is going to pay for more than 30 days. In addition, some states do have a limit on when a prescription can be filled. Some say 60 days. Some don't say anything but leave it up to the pharmacist's judgment to decided if it is ok to fill a prescription for a 900 day supply of Quillivan XR 5 months after the prescription was issued. We all know the answer to that is no. Sure, there is "no federal limit" but in reality, you can't go by that.
 

Apotheker2015

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I agree.
Would also not accept the old C-II bottle for disposal unless registered with the DEA as an authorized take-back site.
On the take-back... yes, and no. Some states allow a pharmacy to take back a previously dispensed medication by that pharmacy if the medication dispensed is expired, defective, or it it was dispensed in error. 90mL extra were dispensed in error. That could fit within category. Another provision some states have is that a pharmacist can accept a previously dispensed medication if in the professional judgment of the pharmacist substantial harm could result to the public or a patient if they were to remain in the possession of the patient, patient’s family or agent. The issue at hand could fit within this provision. as well, if of course, her state allows that.
 

Dr Wario

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Why. This is a moronic assumption. You should never assume. Especially with a C-II. The patient may be instructed by the prescriber to increase the dose verbally and then provide a new rx days or weeks later especially if they already have a supply in hand.

In your example someone goes to pain management on 8/1 and gets 90 doses at tid. Now they come with a new rx for q4, They would still have to wait 15 days and for a call to the pain management doc to let him know what ios going on as the patient probably violated their contract with pain management. So no, they couldn't get the new rx after getting 90 five days ago.
I am going to assume that you read my post really fast because your reply really does not make any sense. I put in my post that I go by the written date UNLESS otherwise clarified by the doctor. As to your second paragraph, I really have no idea what you were trying to say except what I already said in different words.
 

BenJammin

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Just fill the damn prescription. There is ABSOLUTELY NO precedent set for a pharmacist getting in trouble with the DEA for one patient getting an early refill. There is no federal statute so, assuming you're in a state that doesn't regulate day supplies, you are all getting worked up over nothing.
 

Apotheker2015

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Just fill the damn prescription. There is ABSOLUTELY NO precedent set for a pharmacist getting in trouble with the DEA for one patient getting an early refill. There is no federal statute so, assuming you're in a state that doesn't regulate day supplies, you are all getting worked up over nothing.
She handed out the guy an extra 90 mL for the previous fill. So you're saying she should peddle him another 90mL and she should also do so 9 days early.

Sounds like great advice.
 

Old Timer

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OK. So let's dispense with all of the BS in this thread.
  1. First if this patient is abusing Quillivant XR, he will be the first one. Let's face it. Long acting Methylphenidate is not a hot street drug. It's not for 90 Adderrall 30 mg tablets on a discount card.
  2. If the quantity does not exceed what the prescriber ordered and the package should not be broken, it is not a big deal to dispense the product in full packages and put in a 30 day supply. If you document on the face of the rx why you did it, you will never have an issue on audit. If you want to gave one less bottle and bill for less than 30 days, I have no issue with that, though I wouldn't do it. The same with Trileptal Susp. I only dispense full bottles.
  3. If the dosage increases you should only involve the prescriber if there is any suspicion or red flags that would leave you to believe there is some impropriety. You ask the patient when the doctor increased the dose and do your calculations from there. It's not up to the prescriber to clarify anything unless you ask them to clarify. If you want to call the MD in this case, so be it. I wouldn't
  4. You should not try to turn this into and adversarial situation between you and the patient again unless you suspect something is going on.
  5. There is no Federal limit on the qty of a C-II that can be dispensed as long as the rx is for valid medical purpose and prescribed in the regular course of his/her practice. State laws or insurance limits may cause you to dispense less than the amt ordered by the prescriber, but Federal Law does not.
 
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Apotheker2015

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OK. So let's dispense with all of the BS in this thread.
  1. First if this patient is abusing Quillivant XR, he will be the first one. Let's face it. Long acting Methylphenidate is not a hot street drug. It's not for 90 Adderrall 30 mg tablets on a discount card.
  2. If the quantity does not exceed what the prescriber ordered and the package should not be broken, it is not a big deal to dispense the product in full packages and put in a 30 day supply. If you document on the face of the rx why you did it, you will never have an issue on audit. If you want to gave one less bottle and bill for less than 30 days, I have no issue with that, though I wouldn't do it. The same with Trileptal Susp. I only dispense full bottles.
  3. If the dosage increases you should only involve the prescriber if there is any suspicion or red flags that would leave you to believe there is some impropriety. You ask the patient when the doctor increased the dose and do your calculations from there. It's not up to the prescriber to clarify anything unless you ask them to clarify. If you want to call the MD in this case, so be it. I wouldn't
  4. You should not try to turn this into and adversarial situation between you and the patient again unless you suspect something is going on.
  5. There is no Federal limit on the qty of a C-II that can be dispensed as long as the rx is for valid medical purpose and prescribed in the regular course of his/her practice. State laws or insurance limits may cause you to dispense less than the amt ordered by the prescriber, but Federal Law does not.
Old Timer,

1. Whether you choose to accept it or not, Quillivant XR is a schedule II controlled substance according to the controlled substances act. Abusing a drug is not necessarily just getting a high from it or taking an absurd amount of it. Just taking a drug that is not prescribed for you entails abuse. Methylphenidate has the same potential for abuse as Adderall XR. It's a stimulant. It's a C-II. Done. In fact, the metabolism of methylphenidate is quite interesting. It is quite similar to cocaine's in the sense that if you drink alcohol, it kicks it back into your system and you get a second boost. If you take too much of it, you will get the same psychosis you would get with adderall, similar increase in blood pressure and delay in growth. So they're really not all that different. Sure, methylphenidate is only a dopamine reuptake inhbitor and adderall is a releasing agent and inhibits reuptake of dopamine and norepinephrine, as well. It's pretty strong and has a high potential for abuse.

2. Insurance billing and possibly facing an audit is the least important of the issues here. The initial dose of 75 mg/day is obscenely high. That's the first issue. The father received an extra 90 mL of it. 15 mL/day x 30 days = 450 mL. It's a C-II. It's not amoxicillin or a frozen yogurt shake. You can't just hand the person an extra 90 mL of a C-II. Her inventory is already short and will continue to be unless she dispenses 90 mL less this time and continues to dispense the exact volume the patient needs, per the sig. Were she to follow your logic here, then she would be dispensing four- 180 mL bottles for a total of 720 mL, when the patient only needs 20 mL per day; i.e., 600 mL per month. Were she to do that 12 times -assuming a monthly fill-, you are looking at a deficit of 1,440 mL (120 mL x 12 months) per year and 2,880 mL when you do your biennial inventory; i.e., sixteen - 180mL bottles. Really? How would you explain that?

3. The 75 mg/day dose should have never been dispensed. It is too high. Doses above 60 mg/day were not studied in any of the 45 pediatric patients in the clinical study. 45... that's it. Thus, to increase the dose to 100 mg is nonsense.

4. You keep going back to the federal limit. The lack of a federal limit does not even matter when we all know that there is likely a stricter regulation set by state law. In addition, whatever she dispenses has to match the quantity calculated by the SIG. The prescriber can write: Dispense 8 bottles. Why would you do that if you know the SIG tells you the patient will need a total of 450 mL/month for the previous fill and only 600 mL in order to provide a daily dose of 100 mg.

She is doing the right thing by coming forward and asking this valid question. She is also doing the right thing by questioning why he wants the medication 9 days early when he clearly should have an extra 6 day supply that should be intact at home. The suspension is stable for up to 4 months after reconstitution. However, it must be dispensed in the original container. Thus, setting aside the left over 90 mL to dispense them with the next fill is not an option. In that case, you have to waste it and document that or you secure it and wait until it expires. Then you order the 120 mL bottles for next time so that you do not have to deal with any waste.

Once again, you can't just hand out 90 mL of Quillivant XR. I doubt she will continue to give away extra volume to this patient. If she chooses not to practice pharmacy the way you would, that is OK, too. Though, to be clear, selling/handing out schedule II controlled substances without a prescription and legitimate medical purpose does not fit within the definition of practice of pharmacy. She would not be "dispensing" those 90 mL. She would literally be "selling" that volume. You only "dispense" pursuant to a prescription order.

Best,

Apotheker2015
 

Apotheker2015

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I am going to assume that you read my post really fast because your reply really does not make any sense. I put in my post that I go by the written date UNLESS otherwise clarified by the doctor. As to your second paragraph, I really have no idea what you were trying to say except what I already said in different words.
*He tends to do that...
 

BenJammin

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She handed out the guy an extra 90 mL for the previous fill. So you're saying she should peddle him another 90mL and she should also do so 9 days early.

Sounds like great advice.
If the patient isn't abusing the medication then what is the big deal? Nothing disturbs me more than hearing about pharmacists enforcing made up laws.
 

CountBy5s

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Just document, PDMP, clarify with MD. And CYA as much as possible before releasing any C2 early.

If the directions changed and the M.D. confirms not office staff but M.D. confirms early release. No red flags (consistent M.D., fill history avoid of multiple controls etc.). I would probably let it go.
 

owlegrad

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Why would the inventory be short? That's dumb. The inventory is not going to be short, they are going to be recording the amount dispensed.

Now you could make the point that the patient would be getting that much extra per year. But it's not going to be short on the inventory.

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Apotheker2015

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Why would the inventory be short? That's dumb. The inventory is not going to be short, they are going to be recording the amount dispensed.

Now you could make the point that the patient would be getting that much extra per year. But it's not going to be short on the inventory.

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You don't have a prescription to back up those 16 extra 180mL bottles that were sold.
 

Apotheker2015

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Why would the inventory be short? That's dumb. The inventory is not going to be short, they are going to be recording the amount dispensed.

Now you could make the point that the patient would be getting that much extra per year. But it's not going to be short on the inventory.

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Yikes, it must be really "dumb" as I've never heard you call anyone dumb around here.
 

Apotheker2015

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Why would the inventory be short? That's dumb. The inventory is not going to be short, they are going to be recording the amount dispensed.

Now you could make the point that the patient would be getting that much extra per year. But it's not going to be short on the inventory.

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I do have to ask you to explain why it's dumb to not want to hand out 16 bottles of Quillivant XR without a prescription order to back them up.
 

owlegrad

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You don't have a prescription to back up those 16 extra 180mL bottles that were sold.
Sure, and the moon is nearer to the earth than the sun. What does the one have to do with the other?

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owlegrad

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I do have to ask you to explain why it's dumb to not want to hand out 16 bottles of Quillivant XR without a prescription order to back them up.
Oh no I have no issue with wanting to not overdespence. Makes sense to me.

But it's silly to claim that you'll be short on the inventory. As long as you are logging the amount you actually dispense the inventory will be fine. Stick to the real issues not inventing fake ones.

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KidPharmD

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I am with those that wouldn't have dispensed the 75mg/day in the first place unless the prescriber was a psychiatrist.

Additionally, I think a lot of the quantity issues depend on how it was recorded. For our PDMP: records must be sent accurately. So if you dispensed a 36 day supply but only recorded a 30 day supply (because insurance wouldn't let you run 36 days through) that would get you in trouble with more than one group of people.

Here is a similar situation (that wouldn't happen): You get an Rx for Oxy IR 30mg TID #100. You run this through as a 33 day supply and the insurance rejects it. Because you don't want to break a bottle, you re-run it through as a 30 day supply. The patient then gets this filled every month exactly 30 days apart (which insurance allows because you said that 100 tabs were 30 days worth. By then end of the year they have 120 extra tablets of oxycodone even though their PDMP file looks perfectly clean.

Yes, I know that patients with PRN Rx's can stock up supplies in much the same way by taking less than the Rx is written for but still getting it filled, but you don't have a way of actually monitoring that they are taking their pills, do you?
 
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Old Timer

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1. Whether you choose to accept it or not, Quillivant XR is a schedule II controlled substance according to the controlled substances act. Abusing a drug is not necessarily just getting a high from it or taking an absurd amount of it. Just taking a drug that is not prescribed for you entails abuse. Methylphenidate has the same potential for abuse as Adderall XR. It's a stimulant. It's a C-II. Done. In fact, the metabolism of methylphenidate is quite interesting. It is quite similar to cocaine's in the sense that if you drink alcohol, it kicks it back into your system and you get a second boost. If you take too much of it, you will get the same psychosis you would get with adderall, similar increase in blood pressure and delay in growth. So they're really not all that different. Sure, methylphenidate is only a dopamine reuptake inhbitor and adderall is a releasing agent and inhibits reuptake of dopamine and norepinephrine, as well. It's pretty strong and has a high potential for abuse.
Lets get real. All C-II drugs do not have the same potential for abuse. Oxycodone is more abused than methylphenidate. Adderall IR is more abused than Methylphenidate ER.

2. Insurance billing and possibly facing an audit is the least important of the issues here. The initial dose of 75 mg/day is obscenely high. That's the first issue. The father received an extra 90 mL of it. 15 mL/day x 30 days = 450 mL. It's a C-II. It's not amoxicillin or a frozen yogurt shake. You can't just hand the person an extra 90 mL of a C-II. Her inventory is already short and will continue to be unless she dispenses 90 mL less this time and continues to dispense the exact volume the patient needs, per the sig. Were she to follow your logic here, then she would be dispensing four- 180 mL bottles for a total of 720 mL, when the patient only needs 20 mL per day; i.e., 600 mL per month. Were she to do that 12 times -assuming a monthly fill-, you are looking at a deficit of 1,440 mL (120 mL x 12 months) per year and 2,880 mL when you do your biennial inventory; i.e., sixteen - 180mL bottles. Really? How would you explain that?
First, I was not addressing the appropriateness of the dosage. I agree it is a high dose and I would probably check that out before dispensing. That is not what I am addressing. What I am auguring is assuming the dosage is safe an appropriate, what do you do when there is a dosage increase.


4. You keep going back to the federal limit. The lack of a federal limit does not even matter when we all know that there is likely a stricter regulation set by state law. In addition, whatever she dispenses has to match the quantity calculated by the SIG. The prescriber can write: Dispense 8 bottles. Why would you do that if you know the SIG tells you the patient will need a total of 450 mL/month for the previous fill and only 600 mL in order to provide a daily dose of 100 mg.
You are not accurately stating my position. I also noted, that an individual state may have more restrictive rules but the Federal Law is not only silent, it comes right out and says there is no qty limit. I am also pointing there are times when you dispense more than the insurance limit if you are dealing with sealed packages. I do not condone giving an extra full package. But if the 3 bottles is 36 days and 2 bottles are 24 days, I would give three bottles as long as the rx was for 3 bottles. I also noted I would not have an issue with giving 2 bottles. [/QUOTE]

She is doing the right thing by coming forward and asking this valid question. She is also doing the right thing by questioning why he wants the medication 9 days early when he clearly should have an extra 6 day supply that should be intact at home. The suspension is stable for up to 4 months after reconstitution. However, it must be dispensed in the original container. Thus, setting aside the left over 90 mL to dispense them with the next fill is not an option. In that case, you have to waste it and document that or you secure it and wait until it expires. Then you order the 120 mL bottles for next time so that you do not have to deal with any waste.
I never said she should not question any of this. She needs to determine when the dosage changed and then determine id the patient has any left and decide to dispense or not based on that information. DO NOT assume the date of the new rx is the date the therapy changed. I would never split a bottle and damage the rest. Too many years as an independent. You can go broke doing that. Also, plan may not reimburse enough if there is a price differential between the smaller and larger size. There may not be. It's just another consideration. I just had an incident last with test strips 100 1 per day. Thirty day limit so I billed for a box of 25 and it was rejected. Smallest size they pay for is 50. Go figure......

Once again, you can't just hand out 90 mL of Quillivant XR. I doubt she will continue to give away extra volume to this patient. If she chooses not to practice pharmacy the way you would, that is OK, too. Though, to be clear, selling/handing out schedule II controlled substances without a prescription and legitimate medical purpose does not fit within the definition of practice of pharmacy. She would not be "dispensing" those 90 mL. She would literally be "selling" that volume. You only "dispense" pursuant to a prescription order.


You love to make wild assumptions. You assume it has no legitimate medical purpose. A decision you do not have the ability to make witjout a discussion withe the prescriber. I have never advocated dispensing more units than the prescriber allowed. Where you got that from I have not the slightest clue. There is no shortage. Nothing like that.
 

Dr Wario

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I am also pointing there are times when you dispense more than the insurance limit if you are dealing with sealed packages. I do not condone giving an extra full package. But if the 3 bottles is 36 days and 2 bottles are 24 days, I would give three bottles as long as the rx was for 3 bottles. I also noted I would not have an issue with giving 2 bottles.
Woah wtf are you kidding? Of course there are times when the smallest, unbreakable package of a drug would be over a 30 day supply based on directions and you bill for 30 days, but you are seriously saying you would commit insurance fraud and bill 3 bottles that should be a 36 day supply as 30 days? Now if you billed the 60ml bottle as a 30 day supply and the directions said take 1.5ml per day that is completely different, but what you are talking about can easily get you audited and backcharged for that entire prescription. If 3 bottles = 36 day supply I would give the patient a choice, fill the entire script as cash or reduce the quantity to < or = 30 days (as could be done with full bottles) and void the remainder.
 

Old Timer

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Woah wtf are you kidding? Of course there are times when the smallest, unbreakable package of a drug would be over a 30 day supply based on directions and you bill for 30 days, but you are seriously saying you would commit insurance fraud and bill 3 bottles that should be a 36 day supply as 30 days? Now if you billed the 60ml bottle as a 30 day supply and the directions said take 1.5ml per day that is completely different, but what you are talking about can easily get you audited and backcharged for that entire prescription. If 3 bottles = 36 day supply I would give the patient a choice, fill the entire script as cash or reduce the quantity to < or = 30 days (as could be done with full bottles) and void the remainder.
Your choice. I have been doing this for 35 years. They would only take the overage, not the whole thing. They would prefer it my way, less fees to pay. I said I would have no problem doing it your way.
 

Apotheker2015

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Lets get real. All C-II drugs do not have the same potential for abuse. Oxycodone is more abused than methylphenidate. Adderall IR is more abused than Methylphenidate ER.

Sure... appeal the C-II status to your legislators or the DEA. It's a C-II. Read the package insert and compare to any other stimulant's package insert. I would ask you to read through it all but I doubt you would know what to do with one. It's unlikely that you ever look at package inserts after all you've been doing this for 35 years.

First, I was not addressing the appropriateness of the dosage. I agree it is a high dose and I would probably check that out before dispensing. That is not what I am addressing. What I am auguring is assuming the dosage is safe an appropriate, what do you do when there is a dosage increase.

Meh... You can't tell someone to fill it without addressing the appropriateness of the dosage. That should have been the first thing that jumped at you. THE DOSE! The only other person who jumped on the dosage issue was @idiot. You're acknowledging it now because I called you out on it. Others dismissevalid question with "you're over complicating it

You are not accurately stating my position. I also noted, that an individual state may have more restrictive rules but the Federal Law is not only silent, it comes right out and says there is no qty limit. I am also pointing there are times when you dispense more than the insurance limit if you are dealing with sealed packages. I do not condone giving an extra full package. But if the 3 bottles is 36 days and 2 bottles are 24 days, I would give three bottles as long as the rx was for 3 bottles. I also noted I would not have an issue with giving 2 bottles.
You said "I would give three bottles as long as the rx was for 3 bottles." Who talks about bottles these days? You can't rely on physicians to tell you how many bottles. Where are you getting the total quantity from? From the SIG or from the "dispense 3 bottles" part the physician wrote on the script that Swatchgirl is talking about?
The initial prescription was for a volume of 450mL. That's what should be dispensed if the dose were actually appropriate. Any volume over 450 mL is being sold without a prescription. You get the total quantity from the SIG. And I know that you are about to hop on your "35 years of experience" horse... Do it. If a prescription for a C-II is for 450 mL, I dispense 450 mL and record the rest as waste with a witness. I'm not giving anyone anything extra regardless of what total quantity the physician wrote. Total quantity and SIG have to match. When they do not match, the SIG overrides the total quantity in most cases (unless of course, the physician only wants a 7 day supply. Sure, you would not dispense a 30 day supply if the prescription clearly says "dispense a 7 day supply".

This is where I am getting that you would dispense in "full packages" a 36 day supply and "put in" a 30 days supply. I am assuming that the 30 day supply you "put in" is the quantity that you record on the patient profile, bill insurance for, and report to the PDMP. This quantity also gets subtracted from your inventory.

"If the quantity does not exceed what the prescriber ordered and the package should not be broken, it is not a big deal to dispense the product in full packages and put in a 30 day supply. If you document on the face of the rx why you did it, you will never have an issue on audit. If you want to gave one less bottle and bill for less than 30 days, I have no issue with that, though I wouldn't do it. The same with Trileptal Susp. I only dispense full bottles."

I never said she should not question any of this. She needs to determine when the dosage changed and then determine id the patient has any left and decide to dispense or not based on that information. DO NOT assume the date of the new rx is the date the therapy changed. I would never split a bottle and damage the rest. Too many years as an independent. You can go broke doing that. Also, plan may not reimburse enough if there is a price differential between the smaller and larger size. There may not be. It's just another consideration. I just had an incident last with test strips 100 1 per day. Thirty day limit so I billed for a box of 25 and it was rejected. Smallest size they pay for is 50. Go figure......

I never assumed that the date of the new prescription is the date the therapy changed. I've said over and over that she should check with the prescriber. I also mentioned that often times physicians will give patients the green light over the phone to increase the dose way before the new script is issued.

You love to make wild assumptions. You assume it has no legitimate medical purpose. A decision you do not have the ability to make witjout a discussion withe the prescriber. I have never advocated dispensing more units than the prescriber allowed. Where you got that from I have not the slightest clue. There is no shortage. Nothing like that.
[/QUOTE]

I am not making any wild assumptions. You like to say that a lot to people and then pull out the 35 years of experience card. When I said that "it has no legitimate medical purpose" I was referring to the extra volume being dispensed. It's blatant that is what I am referring to.That volume represents additional doses. Those have no legitimate purpose because the patient is not supposed to get those doses. They're not covered by the SIG. That is the case in the two states I am licensed in. Whatever leaves the pharmacy has to match the total quantity on the face of the prescription; i.e., the total quantity as calculated by the SIG. So yes, there is a shortage. Of course, there is. When you do inventory, you are comparing what you purchased from your supplier vs the quantities you dispensed. The quantity dispensed is determined by the SIG or the total quantity written on the prescription, whichever is less. If what you purchased does not equal what you have on the shelves + the quantity that you should have dispensed, then you should have a record of waste somewhere. If you do not, then you were over-dispensing. Thus, your inventory is short. Otherwise, how do you think an inventory is done?

What comes in has to match what goes out and if it does not, then it needs to be documented. "Did not want to split a bottle and damage the rest" is not valid documentation for any company, board of pharmacy or DEA. You have your reasons to practice your way. Go ahead. "Doing this for 35 years" does not mean you have been or that you are doing it right. I go by the book. If a prescription calls for 450 mL for 30 days and insurance only pays for 30 days and the closest I can get to that quantity is with three 180 mL bottles. I have two choices: 1. dispense 450 mL and waste 90 mL. 2. Not break up the bottles and not dispense it at all. Done. There is no "Did not want to split a bottle and damage the rest." So I gave the patient the extra volume even though that adds up to an additional 6 doses". All that documenting here and there, little exceptions here and there, that creates confusion and problems and will eventually get someone in trouble. And that is why I will never go to an independent pharmacy. Give me streamlined processes, rules and I'll make sure they're enforced.
 

Apotheker2015

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Why would the inventory be short? That's dumb. The inventory is not going to be short, they are going to be recording the amount dispensed.

Now you could make the point that the patient would be getting that much extra per year. But it's not going to be short on the inventory.

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Owlegrad,

Here is what I am understanding from you:
  1. You are saying that by recording 540 mL instead of 450 mL, the problem is solved.
  2. I am working under the assumption that you are:
    1. dispensing and recording this as a 30 day supply.
    2. reporting it as a 30-day supply to the PDMP.
    3. billing insurance for a 30-day supply.
In the two states that I am licensed in, you cannot give extra. If that means you waste some, then that's what you do. When you do inventory, you are comparing what you purchased from your supplier vs the quantities you dispensed. The quantity dispensed is determined by the SIG or the total quantity written on the prescription, whichever is less. The quantity that should be dispensed can't possibly be determined by what's convenient to dispense.

If what you purchased does not equal what you have on the shelves + the quantity that you should have dispensed, then you should have a record of waste somewhere. If you do not, then you were over-dispensing. Thus, your inventory is short. Those extra mL should have never been sold because they were not dispensed pursuant to a prescription. One of the two states I am licensed in, requires a monthly C-II inventory. The CVS system prompts you to count C-IIs every day. They pop up in QV. Not all get counted every day, of course. The ones that are slow movers pop up in QV just once a month. The fast movers pop up in QV several times a week It's down to the tablet and it is down to the mL. It is exact and it must match. The system knows what has been purchased vs. what has been dispensed and what should have been dispensed. If those don't match, of course, that will prompt an audit, likely an internal audit. Where are those bottles? You can't tell the auditor you did not want to waste those 90 mL each time. That's not a valid reason to anyone. Otherwise, how do you think an inventory is done? I'm curious now.

I've read plenty of disciplinary proceedings involving pharmacists who either underdispense or overdispense. Neither state board of pharmacy is keen on that. The Midwest is crackhead central. That won't fly here.

Best,

Apotheker2015
 

Old Timer

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All that documenting here and there, little exceptions here and there, that creates confusion and problems and will eventually get someone in trouble. And that is why I will never go to an independent pharmacy. Give me streamlined processes, rules and I'll make sure they're enforced.
You enforce rules that do not exist. Only in your imagination. If a drug comes in a package that cannot be broken. I will dispense that package size, Period. When you get an rx for Poly-Vi-SOl 1 ml daily and the welfare that pays for it limits you to 30 days you dispense 1 bottle of 50ml and put in 30 days for the insurance. You do not split the bottle. If a doctor orders mupirocin ointment 15 gm, you do noy weigh out 15 gm of 22 gm tube and put it in ointment jar.

Certainly C-II rxs complicate things as you cannot dispense more qty than allowed by the prescriber. You are assuming facts not in evidence. I am not assuming the doctor wrote 4 bottles. I am assuming the doctor wrote a specific amount and we are trying to navigate this under state and federal laws as well as insurance constraints. Forgetting the maximum dose issues for a second. If you get an RX for this drug for 20 ml per day disp 720 ml. I would probably order the 120 ml bottles and dispense the 30 day supply unless the insurance company penalizes me for using the smaller bottle. In that case I would dispense the 720 ml for a 30 day supply, noting the reasons on the face of the rx. The same goes with Trileptal Suspension. The same for AIDS drugs that cannot be opened. The list is endless. What about Flonase 1 spray daily or Ventolin 1 puff qid. All more than 30 days. What do you do, hand it back and say It's more than 30 days, I would be committing fraud, go mail order? I suppose you also open boxes of insulin pens, lancets and other similar items.

I would never be in a position where I would dispense a partial bottle of an item that has a short shelf life once opened.

As for my experience. I do do it correctly. I follow any laws that apply to me, I just don't make up extra laws to follow. I don't look for trouble where none exists. If your state law is different you have to follow the laws that apply to you.
 

Apotheker2015

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You enforce rules that do not exist. Only in your imagination. If a drug comes in a package that cannot be broken. I will dispense that package size, Period. When you get an rx for Poly-Vi-SOl 1 ml daily and the welfare that pays for it limits you to 30 days you dispense 1 bottle of 50ml and put in 30 days for the insurance. You do not split the bottle. If a doctor orders mupirocin ointment 15 gm, you do noy weigh out 15 gm of 22 gm tube and put it in ointment jar.

Certainly C-II rxs complicate things as you cannot dispense more qty than allowed by the prescriber. You are assuming facts not in evidence. I am not assuming the doctor wrote 4 bottles. I am assuming the doctor wrote a specific amount and we are trying to navigate this under state and federal laws as well as insurance constraints. Forgetting the maximum dose issues for a second. If you get an RX for this drug for 20 ml per day disp 720 ml. I would probably order the 120 ml bottles and dispense the 30 day supply unless the insurance company penalizes me for using the smaller bottle. In that case I would dispense the 720 ml for a 30 day supply, noting the reasons on the face of the rx. The same goes with Trileptal Suspension. The same for AIDS drugs that cannot be opened. The list is endless. What about Flonase 1 spray daily or Ventolin 1 puff qid. All more than 30 days. What do you do, hand it back and say It's more than 30 days, I would be committing fraud, go mail order? I suppose you also open boxes of insulin pens, lancets and other similar items.

I would never be in a position where I would dispense a partial bottle of an item that has a short shelf life once opened.

As for my experience. I do do it correctly. I follow any laws that apply to me, I just don't make up extra laws to follow. I don't look for trouble where none exists. If your state law is different you have to follow the laws that apply to you.
Of course, I am referring to C-IIs, namely C-II suspensions. Now you're bringing up mupirocin, etc. Yes, it is different here and that's what I just explained and that is what I will do.
 

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You said "I would give three bottles as long as the rx was for 3 bottles." Who talks about bottles these days? You can't rely on physicians to tell you how many bottles. Where are you getting the total quantity from? From the SIG or from the "dispense 3 bottles" part the physician wrote on the script that Swatchgirl is talking about?
The initial prescription was for a volume of 450mL. That's what should be dispensed if the dose were actually appropriate. Any volume over 450 mL is being sold without a prescription. You get the total quantity from the SIG.
If the script is as the OP says, "15ml qday, disp. 3 180ml bottles" then the quantity you should dispense is 540 ml. What's so hard about this? Why do you keep saying 450 ml? The script doesn't say "15ml qday x30 days." Even Florida law doesn't say that (from my brief search, maybe I'm wrong). There is no legal reason 3 180ml bottles can't be dispensed. No drug is being dispensed without a prescription.

Why can't a prescriber write for bottles? I see and fill all the time for 1 tube, 1 inhaler, 1 box, 1 whatever. If there is an issue with different sizes (30gm vs 80gm tube) then I call and clarify, but there is still nothing wrong with writing for a unit like that especially when they do specify the size.