Testosterone Cyp Days Supply Limit Question (Texas especially)

[Wickett]

Hey guys....I have tried finding an answer to this but haven't reached a clear conclusion. If there is another post I missed or a simple link to lead me too it would be much appreciated. If no one is really sure, I will just contact the State Board on Monday to see if they can clarify as well as contact corporate.

My issue:

I am a pharmacist in Texas. I have a particular patient (someone I am quite sure would not be afraid to file a complaint if the situation isn't handled correctly). Because of this I want to be sure I do everything properly/correct, especially if I am not able to give them what they want. Elderly patient has received 1mL vials in the past for testosterone injections, and he came by today saying he wants a 10mL vial because his doctor said it would be cheaper that way/complaints about the cost. Their insurance doesn't cover/they will pay cash, so no issues worrying about insurance wanting max 90 days.

If I were to fill the 10mL vial, according to MD instructions, it would come out to be a 5-6 month supply. I have been unable to find anything concrete from looking up Texas or general DEA regulations when it comes to a maximum days supply for a single controlled fill. It falls under the general 6 month window for a controlled script, but I have never filled beyond 90 days for a controlled fill so I am a bit wary to fill an entire 10mL vial at its prescribed days supply, nor have I found DEA and/or TSBP opinions on this. I also have concerns since the CDC recommends a 28 day BUD once a vial is punctured, and he would be using it much longer than that.

I also haven't had much success to find and verify if the 10mL products have a legitimate BUD once punctured beyond the recommended 28 days or not/what the State Board feels about that. I have been unable to find anything online and the plan is if I need to, contact the manufacture on Monday and try to find out directly from them.

So to sum up my TL;DR post, I want to hear what some of you think about this/your opinions on how to handle 10mL testosterone fills for a cash payer. The patient is very particular/prone to offense, but is not someone I am concerned about abuse/drug seeking behavior. Currently this is what I can do:

a. Just fill the 10mL vial under the proper days supply as a cash payer and be done with it. This
is the least path of resistance and will make the customer the most happy, but I worry this is frowned upon and may open up to DEA audit or general future issues, including possible infection.
b. Inform the patient that we can only fill 1mL vials at a time due to the excessive days supply with a 10mL vial; chaos erupts and probably get a corporate complaint. However, more secure about being in compliance
c. Inform patient of the risks of infection/the CDC recommendation not to use the same vial for
more than 28 days. Recommend to stick to 1mL vial, but document they and their MD is aware
of the risk if they choose to go with 10mL and counsel on aseptic technique. Obviously just a better version of option A, minus some risk patient will get upset/think I am just trying to steer them to the 1mL.

Sorry for the long post, but this particular person has caused issues in the past. I am trying to get all the info so I can try to follow best practices while also trying to prevent another customer service headache. Any input is appreciated and sorry once again for the post length.

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[CetiAlphaFive]

Hey guys....I have tried finding an answer to this but haven't reached a clear conclusion. If there is another post I missed or a simple link to lead me too it would be much appreciated. If no one is really sure, I will just contact the State Board on Monday to see if they can clarify as well as contact corporate.

My issue:

I am a pharmacist in Texas. I have a particular patient (someone I am quite sure would not be afraid to file a complaint if the situation isn't handled correctly). Because of this I want to be sure I do everything properly/correct, especially if I am not able to give them what they want. Elderly patient has received 1mL vials in the past for testosterone injections, and he came by today saying he wants a 10mL vial because his doctor said it would be cheaper that way/complaints about the cost. Their insurance doesn't cover/they will pay cash, so no issues worrying about insurance wanting max 90 days.

If I were to fill the 10mL vial, according to MD instructions, it would come out to be a 5-6 month supply. I have been unable to find anything concrete from looking up Texas or general DEA regulations when it comes to a maximum days supply for a single controlled fill. It falls under the general 6 month window for a controlled script, but I have never filled beyond 90 days for a controlled fill so I am a bit wary to fill an entire 10mL vial at its prescribed days supply, nor have I found DEA and/or TSBP opinions on this. I also have concerns since the CDC recommends a 28 day BUD once a vial is punctured, and he would be using it much longer than that.

I also haven't had much success to find and verify if the 10mL products have a legitimate BUD once punctured beyond the recommended 28 days or not/what the State Board feels about that. I have been unable to find anything online and the plan is if I need to, contact the manufacture on Monday and try to find out directly from them.

So to sum up my TL;DR post, I want to hear what some of you think about this/your opinions on how to handle 10mL testosterone fills for a cash payer. The patient is very particular/prone to offense, but is not someone I am concerned about abuse/drug seeking behavior. Currently this is what I can do:

a. Just fill the 10mL vial under the proper days supply as a cash payer and be done with it. This
is the least path of resistance and will make the customer the most happy, but I worry this is frowned upon and may open up to DEA audit or general future issues, including possible infection.
b. Inform the patient that we can only fill 1mL vials at a time due to the excessive days supply with a 10mL vial; chaos erupts and probably get a corporate complaint. However, more secure about being in compliance
c. Inform patient of the risks of infection/the CDC recommendation not to use the same vial for
more than 28 days. Recommend to stick to 1mL vial, but document they and their MD is aware
of the risk if they choose to go with 10mL and counsel on aseptic technique. Obviously just a better version of option A, minus some risk patient will get upset/think I am just trying to steer them to the 1mL.

Sorry for the long post, but this particular person has caused issues in the past. I am trying to get all the info so I can try to follow best practices while also trying to prevent another customer service headache. Any input is appreciated and sorry once again for the post length.

Easy.
Ask the patient if their "low T" is due solely to age. *Don't ask the clinics. They're probably gonna lie to you.

If they say yes, refuse to fill and cite "not prescribed for a legitimate medical use. Old men have Low testosterone, and the FDA/CDC advises against using test cyp in elderly males. Risk of heart disease/cancer"
^ this makes you bullet proof with corporate ^


That is MUCH more significant than any risk for infection.

There is no single fill days supply limit in Texas except for NP/PA.

Don't be scared of roided up geezers.

I used to make PAs and NPs at the "male health" clinics furious because I'd refuse to fill 10mL vials from them because they're limited to 90 days in Texas.

EDIT:

Aseptic technique?
How do you think that will help?

 

[Wickett]

Easy.
Ask the patient if their "low T" is due solely to age.

If they say yes, refuse to fill and cite "not prescribed for a legitimate medical use. Old men have Low testosterone, and the FDA/CDC advises against using test cyp in elderly males. Risk of heart disease/cancer"


I used to make PAs and NPs at the "male health" clinics furious because I'd refuse to fill 10mL vials from them because they're limited to 90 days in Texas.

EDIT:

Aseptic technique?
How do you think that will help?

With this customer, taking that hard line would not be advisable although I agree with you on principle (trust me/not going to go into much detail here on that, but it would not be in my best interest). My main thing here is to try and figure out if in Texas you can fill for such a long supply without having to worry about either the board or DEA possibly coming down on you about it.

Aseptic technique I mentioned just because if I were to give out a MDV for that long of personal patient use, I would just want to minimize the risk of infection for their sake and my general peace of mind.

 

[zelman]

With this customer, taking that hard line would not be advisable although I agree with you on principle (trust me/not going to go into much detail here on that, but it would not be in my best interest). My main thing here is to try and figure out if in Texas you can fill for such a long supply without having to worry about either the board or DEA possibly coming down on you about it.

Aseptic technique I mentioned just because if I were to give out a MDV for that long of personal patient use, I would just want to minimize the risk of infection for their sake and my general peace of mind.

DEA won’t care. There is no federal limit on CIII Rx duration. I’m not licensed in TX, so I can’t tell you about the BOP’s opinion on the matter.

I would probably fill it for cash and append “discard after 28 days” or whatever length of time the manufacturer says is okay to the end of the directions. Then it’s in writing in their medical record to CYA. They will ignore it anyway.

 

[npage148]

Just order 1ml vials and refuse to dispense anything thing else. Dispensing of 10ml test vials is a pet peeve. It blows up can dispensing limits. The patient will use it for 6-9months despite 28 bud and will love you for only charging a single copay

 

[Sine Cura]

You know a board inspector would be like "CIII are only valid for 6 months yet you dispensed a single 10 mL vial at 0.25 mL once a week for 280 days. A reasonable pharmacist would not dispense this blah blah blah this prescribing not in the usual course of practice blah blah blah"

There is lots of dumb prescribing like writing for albuterol nebs 0.5%. Doesn't mean you have to go along with it

 

[maria1oh]

I lost a customer because I refused to give him 10 ml vial instead of 1 ml. Life goes on. Take his complaint and let him try elsewhere.
I tried asking what his diagnosis was and he told me none of my business.

 

[zelman]

...I tried asking what his diagnosis was and he told me none of my business.

“...that’s literally my business.”

 

[quickpic007]

Hey guys....I have tried finding an answer to this but haven't reached a clear conclusion. If there is another post I missed or a simple link to lead me too it would be much appreciated. If no one is really sure, I will just contact the State Board on Monday to see if they can clarify as well as contact corporate.

My issue:

I am a pharmacist in Texas. I have a particular patient (someone I am quite sure would not be afraid to file a complaint if the situation isn't handled correctly). Because of this I want to be sure I do everything properly/correct, especially if I am not able to give them what they want. Elderly patient has received 1mL vials in the past for testosterone injections, and he came by today saying he wants a 10mL vial because his doctor said it would be cheaper that way/complaints about the cost. Their insurance doesn't cover/they will pay cash, so no issues worrying about insurance wanting max 90 days.

If I were to fill the 10mL vial, according to MD instructions, it would come out to be a 5-6 month supply. I have been unable to find anything concrete from looking up Texas or general DEA regulations when it comes to a maximum days supply for a single controlled fill. It falls under the general 6 month window for a controlled script, but I have never filled beyond 90 days for a controlled fill so I am a bit wary to fill an entire 10mL vial at its prescribed days supply, nor have I found DEA and/or TSBP opinions on this. I also have concerns since the CDC recommends a 28 day BUD once a vial is punctured, and he would be using it much longer than that.

I also haven't had much success to find and verify if the 10mL products have a legitimate BUD once punctured beyond the recommended 28 days or not/what the State Board feels about that. I have been unable to find anything online and the plan is if I need to, contact the manufacture on Monday and try to find out directly from them.

So to sum up my TL;DR post, I want to hear what some of you think about this/your opinions on how to handle 10mL testosterone fills for a cash payer. The patient is very particular/prone to offense, but is not someone I am concerned about abuse/drug seeking behavior. Currently this is what I can do:

a. Just fill the 10mL vial under the proper days supply as a cash payer and be done with it. This
is the least path of resistance and will make the customer the most happy, but I worry this is frowned upon and may open up to DEA audit or general future issues, including possible infection.
b. Inform the patient that we can only fill 1mL vials at a time due to the excessive days supply with a 10mL vial; chaos erupts and probably get a corporate complaint. However, more secure about being in compliance
c. Inform patient of the risks of infection/the CDC recommendation not to use the same vial for
more than 28 days. Recommend to stick to 1mL vial, but document they and their MD is aware
of the risk if they choose to go with 10mL and counsel on aseptic technique. Obviously just a better version of option A, minus some risk patient will get upset/think I am just trying to steer them to the 1mL.

Sorry for the long post, but this particular person has caused issues in the past. I am trying to get all the info so I can try to follow best practices while also trying to prevent another customer service headache. Any input is appreciated and sorry once again for the post length.

If the 1 ML is available in your area it is not prudent to fill a 10 ML day supply quantity because the patient wants it. That is a very good point of the BUD/28 days.
I assume you filled Test Cyp for this guy before so its harder to tell him no, not legitimate medical use due to only age.

Maybe monday the board will answer!

 

[CetiAlphaFive]

With this customer, taking that hard line would not be advisable although I agree with you on principle (trust me/not going to go into much detail here on that, but it would not be in my best interest). My main thing here is to try and figure out if in Texas you can fill for such a long supply without having to worry about either the board or DEA possibly coming down on you about it.

Aseptic technique I mentioned just because if I were to give out a MDV for that long of personal patient use, I would just want to minimize the risk of infection for their sake and my general peace of mind.

Whoops, looks like I edited my post after you quoted it.

Believe me, I've had grumpy old men call the 1 800 number AND report me to the board for refusing to fill their testosterone.
One was a 68 year old man with a history of MI.

Trust me, those testosterone clinic practitioners are truly scum, and all they care about is money.

They'll tell you "well the patient is going to lose weight so it's a positive"

I had complaints, and my district managers would always drop it once I said it was a patient safety problem / not for a legit medical purpose.

Like I said, TSBP/DEA doesn't care about days supply for a single fill, as long as it's not a mid-level.

You know a board inspector would be like "CIII are only valid for 6 months yet you dispensed a single 10 mL vial at 0.25 mL once a week for 280 days. A reasonable pharmacist would not dispense this blah blah blah this prescribing not in the usual course of practice blah blah blah"

There is lots of dumb prescribing like writing for albuterol nebs 0.5%. Doesn't mean you have to go along with it

You're misinterpreting the law, if it's not a mid level. Technically

6 months dictates how long we can fill the prescription for. It has nothing to do with the day supply of a single fill.

 

[Apotheker2015]

I am not licensed in Texas. You can handle this issue the same way you would handle dispensing insulin pens for someone on a very low dose or the same way you would handle dispensing an augmentin suspension for a 25 day supply. Your days supply becomes the beyond-use-date. I'm giving you these examples so that you can extrapolate when these situations arise. Works for me. Fairly newish at this, too.
I would not dispense the 10 mL vial because it's clear that the patient intends to use it for however long it lasts and it's against CDC. USP 797 & Joint commission recommendations.
If 10 mL = 6 months; then 5 mL = 90 days; then you dispense Five 1-mL vials.

You listed all these possible MPJE-like scenarios. Re-read each one of them and ask yourself what happens to your license. Never forget the mission of the board of pharmacy is to protect the public from pharmacists. It's not to protect pharmacists. Otherwise, how do you think CVS got away with not giving pharmacists a 30 -minute uninterrupted lunch break?
You are at the pharmacy to ensure compliance. It's the reason no one can be inside the pharmacy unless you're in it. As long as you are professional, and beat the patient to the punch and inform your DM/Market director/your supervisor that a complaint may be coming their way, you will be fine. Bosses prefer to be aware of complaints before they happen. Otherwise, you end up having to defend your side of the story.
Your license ALWAYS comes first.

 

[CetiAlphaFive]

I am not licensed in Texas. You can handle this issue the same way you would handle dispensing insulin pens for someone on a very low dose or the same way you would handle dispensing an augmentin suspension for a 25 day supply. Your days supply becomes the beyond-use-date. I'm giving you these examples so that you can extrapolate when these situations arise. Works for me. Fairly newish at this, too.
I would not dispense the 10 mL vial because it's clear that the patient intends to use it for however long it lasts and it's against CDC. USP 797 & Joint commission recommendations.
If 10 mL = 6 months; then 5 mL = 90 days; then you dispense Five 1-mL vials.

You listed all these possible MPJE-like scenarios. Re-read each one of them and ask yourself what happens to your license. Never forget the mission of the board of pharmacy is to protect the public from pharmacists. It's not to protect pharmacists. Otherwise, how do you think CVS got away with not giving pharmacists a 30 -minute uninterrupted lunch break?
You are at the pharmacy to ensure compliance. It's the reason no one can be inside the pharmacy unless you're in it. As long as you are professional, and beat the patient to the punch and inform your DM/Market director/your supervisor that a complaint may be coming their way, you will be fine. Bosses prefer to be aware of complaints before they happen. Otherwise, you end up having to defend your side of the story.
Your license ALWAYS comes first.

I agree 100%.

As long as a professional keeps his ducks in a row and is smart, there is no such thing as a situation in which the patient/customer has power over them.

That has to be given away.

Sounds looks OP has given away his leverage because he's scared of a bad attitude.

 

[Wickett]

I agree 100%.

As long as a professional keeps his ducks in a row and is smart, there is no such thing as a situation in which the patient/customer has power over them.

That has to be given away.

Sounds looks OP has given away his leverage because he's scared of a bad attitude.

Not scared, but the timing of a possible complaint would be pretty awful. We already had an issue with this patient and it blew up into this awful thing. I would just like to avoid that hell again.[/QUOTE]

 

[CetiAlphaFive]

Not scared, but the timing of a possible complaint would be pretty awful. We already had an issue with this patient and it blew up into this awful thing. I would just like to avoid that hell again.

I see.

We must just think differently.
I'd jump at a "get out of jail free card" chance at getting rid of that patient.

1.) It would get rid of what sounds like an dingus patient, and 2.) Restore some credibility for you because it would show the patient was the source of the previous problem.

That's just me, though.

 

[owlegrad]

No offense, but if your biggest worry is a baseless complaint something is wrong. There are so many reasons not to dispense that 10ml vial, I wish it wasn't even made. Just refuse to stock it and let the patient go somewhere else to get it.

 

[CetiAlphaFive]

No offense, but if your biggest worry is a baseless complaint something is wrong. There are so many reasons not to dispense that 10ml vial, I wish it wasn't even made. Just refuse to stock it and let the patient go somewhere else to get it.

I'm gonna start spamming the FDA asking why the 10mL is even approved for manufacture if no one could ever possibly use 10mL in 28 days.

 

[owlegrad]

I'm gonna start spamming the FDA asking why the 10mL is even approved for manufacture if no one could ever possibly use 10mL in 28 days.

No worries bro it’s been clarified. They used to get this question all the time but not anymore.

 

[zelman]

I am not licensed in Texas. You can handle this issue the same way you would handle dispensing insulin pens for someone on a very low dose ...

We restarting the box breaking thread, too?

 

[CetiAlphaFive]

No worries bro it’s been clarified. They used to get this question all the time but not anymore.

I wonder if anyone can proof it to me by dispensing a 10mL vials?

 

[owlegrad]

I wonder if anyone can proof it to me by dispensing a 10mL vial?

I would never tell someone to dispense a 10ml vial if I, myself did not routinely dispense it. In fact I only tell people to dispense a 10ml vial if I, myself have that very day dispensed a 10ml vial. Anything else would be dishonest and malicious.

Come to think of it, I don't dispense testosterone at all in my LTC gig for obvious reasons. I guess I don't know what I am talking about and shouldn't be telling people what to do or not to do at all. Sorry about that folks!

 

[maria1oh]

Back in the 70s before testosterone was linked to cardiac problems the doses were much higher and it made sense to have 10ml vial. Since the dangers of testosterone have been studied the high doses no longer make sense.

 

[CetiAlphaFive]

My favorite was when a pot bellied 50 year old came in with a script for an estrogen blocker.

When I called the clinic, I heard the PA clacking furiously on the keyboard.

"L... Low sperm count!"

I laughed and refused the Rx

 

[Apotheker2015]

We restarting the box breaking thread, too?

LOL, if my opinion or stance on an issue changes or evolves, that's life. I have only been a pharmacist for a couple of years and some change. I don't keep track of who I disagree with or what I have said in the past. Do you?

 

[zelman]

... I don't keep track of who I disagree with or what I have said in the past. Do you?

Nope.

 

[Sine Cura]

You're misinterpreting the law, if it's not a mid level. Technically

6 months dictates how long we can fill the prescription for. It has nothing to do with the day supply of a single fill.

I know federal regulations do not address duration of therapy but that is a line of reasoning a BOP inspector would use independent of any state-specific duration of therapy regulations (writing RX or filling RX for excessive duration of therapy is way beyond the usual course of practice)

 

[npage148]

Corresponding Responsibility is a pretty vague duty.

 

[beautifulrobot]

I would go with option C, +/- adding a note on the directions to discard remainder after 28 days.

1) you arent violating any federal laws by dispensing greater than a 90 day supply. No knowledge regarding TX law.
2) you are covering yourself regarding the very conservative 28-day rule for multi-use vials
3) you increase access to medication by reducing cost, and increase patient satisfaction without risk to your license

If you truly have concerns about the medical necessity of testosterone for this patient, it doesn't matter if you dispense it in 10ml vials or 1ml vials, i.e. you shouldn't dispense it at all. Otherwise, just dispense the 10ml and make sure you counsel about the 28 day rule and document it somehow.

I've worked with several patients on testosterone therapy (mostly transgender men). There are several pharmacists that are willing to dispense the 10ml without worry. The 1ml vials are truly a pain, and often difficult to get the full dose out of them, especially if someone is doing 0.5ml per dose, because they are not really overfilled much. Additionally, many patients, especially in the trans population who have experienced barriers to care, and straight-up refusal of care, have reasonable anxiety about access to testosterone. Having the 10ml vial provides a little bit of comfort that you wont go without medication for at least the next few months. Just another perspective to keep in mind - the patient isn't always making things difficult just for the sake of being difficult.

 

[beautifulrobot]

I know federal regulations do not address duration of therapy but that is a line of reasoning a BOP inspector would use independent of any state-specific duration of therapy regulations (writing RX or filling RX for excessive duration of therapy is way beyond the usual course of practice)

Testosterone therapy, when used for appropriate medical reasons, is often lifelong. So duration of therapy that is greater than 90 days isnt excessive from a clinical standpoint. Someone on a stable dose of T only needs annual check ups of labs after the first year of therapy in most cases. If it wasn't a controlled substance it would make sense to write a prescription with a year's worth of refills once the patient has been stable on T for a year.

 

[beautifulrobot]

I wonder if anyone can proof it to me by dispensing a 10mL vials?

I will dispense a 10ml vial as long as i can confirm and document that both the prescriber and patient are aware of the 28 day rule and still prefer the 10 ml vial over the 1 ml vial. I think cost and patient preference are valid reasons for the 10 ml vial when testosterone is being presctibed for a legitimate medical reason.

Eta: assuming my current organization didnt have a policy against the 10 ml vials / dispensing multi-dose vials for use greater than 28 days, which it does. And the reason for the policy is concerns about product integrity after 28 days, not because of any problems with the DEA. I wish i could give my patients the choice, but i can't until the policy changes. At least they dont have to pay for their meds and i can give them 90 days worth of the 1ml vials per fill, so it's not really that big of a deal at the end of the day.

 

[CetiAlphaFive]

I would go with option C, +/- adding a note on the directions to discard remainder after 28 days.

1) you arent violating any federal laws by dispensing greater than a 90 day supply. No knowledge regarding TX law.
2) you are covering yourself regarding the very conservative 28-day rule for multi-use vials
3) you increase access to medication by reducing cost, and increase patient satisfaction without risk to your license

If you truly have concerns about the medical necessity of testosterone for this patient, it doesn't matter if you dispense it in 10ml vials or 1ml vials, i.e. you shouldn't dispense it at all. Otherwise, just dispense the 10ml and make sure you counsel about the 28 day rule and document it somehow.

I've worked with several patients on testosterone therapy (mostly transgender men). There are several pharmacists that are willing to dispense the 10ml without worry. The 1ml vials are truly a pain, and often difficult to get the full dose out of them, especially if someone is doing 0.5ml per dose, because they are not really overfilled much. Additionally, many patients, especially in the trans population who have experienced barriers to care, and straight-up refusal of care, have reasonable anxiety about access to testosterone. Having the 10ml vial provides a little bit of comfort that you wont go without medication for at least the next few months. Just another perspective to keep in mind - the patient isn't always making things difficult just for the sake of being difficult.

That's understandable and reasonable.

Unfortunately, for us in outpatient, they're a practically non existent fraction of our patient population.

Also, my "proof it to me" comment as a joke.

 

[owlegrad]

I will dispense a 10ml vial as long as i can confirm and document that both the prescriber and patient are aware of the 28 day rule and still prefer the 10 ml vial over the 1 ml vial. I think cost and patient preference are valid reasons for the 10 ml vial when testosterone is being presctibed for a legitimate medical reason.

Eta: assuming my current organization didnt have a policy against the 10 ml vials / dispensing multi-dose vials for use greater than 28 days, which it does. And the reason for the policy is concerns about product integrity after 28 days, not because of any problems with the DEA. I wish i could give my patients the choice, but i can't until the policy changes. At least they dont have to pay for their meds and i can give them 90 days worth of the 1ml vials per fill, so it's not really that big of a deal at the end of the day.

So you are telling people to do something you yourself would not do. How malicious of you.

- If you don't get the joke, you don't follow SDN closely enough

 

[beautifulrobot]

So you are telling people to do something you yourself would not do. How malicious of you.

- If you don't get the joke, you don't follow SDN closely enough

Unfortunately, i am missing the joke... been a bit preoccupied the past few days. is there a thread you can refer me to? You've piqued my interest.

(Just for the record, i have dispensed 10ml vials in the past, and would be comfortable doing so now if it werent for an org-specific policy. The reason i even mentioned it was more for the benefit of the OP, i.e. make sure your company doesnt have a policy against dispensing then 10 ml vials, since thats a possibility, too)

 

[owlegrad]

Unfortunately, i am missing the joke... been a bit preoccupied the past few days. is there a thread you can refer me to? You've piqued my interest.

(Just for the record, i have dispensed 10ml vials in the past, and would be comfortable doing so now if it werent for an org-specific policy. The reason i even mentioned it was more for the benefit of the OP, i.e. make sure your company doesnt have a policy against dispensing then 10 ml vials, since thats a possibility, too)

Oh my, I am practically embarrassed to share the link, but since you asked here you go: Oregon BOP's take on the DEA forwarding issue

Also the argument from that thread is a spill over from an even lengthier argument in another thread. That thread I am simply too embarrassed to link to but suffice to say it is more of the same, lol

 

[beautifulrobot]

Oh my, I am practically embarrassed to share the link, but since you asked here you go: Oregon BOP's take on the DEA forwarding issue

Also the argument from that thread is a spill over from an even lengthier argument in another thread. That thread I am simply too embarrassed to link to but suffice to say it is more of the same, lol

Omg. Wow. I made it as far as mid-way of the second page. And yes, I remember the lengthier older thread about this. Thanks for pointing this out.

@CetiAlphaFive , your proof joke makes a lot more sense now, too.

 

[johnpharm01]

Ran into this at work. The multidose vials of testosterone, even with preservative, are only good for 30 days USP standards.

 

[beautifulrobot]

Ran into this at work. The multidose vials of testosterone, even with preservative, are only good for 30 days USP standards.

Technically, the medication is likely still good after 30 days, but USP does have a general 28-day rule for multi dose vials, unless the manufacturer specifies otherwise. Testosterone cypionate is old as dirt and its approval precedes the arbitrary 28-day rule, and the manufacturer has not formally studied the sterility of the 10 ml vial beyond 28 days (and has no financial incentive to do so now), so a prudent pharmacist would not recommend using it beyond 28 days from the first puncture. For this reason i wouldn't recommend dispensing the 10ml vial without documenting that both the patient and prescriber are aware of the (mostly theoretical risk of) lose of sterility after 28 days. Nonetheless, as long as folks arent sticking dirty needles into the vial, are swabbing the vial rubber topper with alcohol before each puncture, etc., the increased risk of infection is very low, and potentially nonexistent, for several months after 28 days from the first puncture (and although time is a factor, also number of re-punctures is a factor, which makes the 28-day rule even more arbitrary). The problem is we dont have manufacturer data that beyond 28 days is ok, so, from a liability perspective, we have to fall back on the 28-day rule. But it's a bit of a misnomer to say that the vial is no longer good after 28 (or 30) days, depending on how you define "good."

TL;DR: 28-day rule is arbitrary, and we don't have data to support that the vial is not good or is good beyond 28 days from the first puncture. (Although i do have plenty of anecdata of patients using the 10 ml for 4-5 months without issue, so i would feel comfortable dispensing the 10 ml vial as long as ive documented that everyone is aware of the 28 day rule as a CYA)

 

[RxRetailRx]

Very good point giga!
However, if BUD is 28 days, what’s the days supply will be? for example with an 10ml vial, pt inject 1ml q weekly, days supply should be 70 or 28 ???

 

[beautifulrobot]

Very good point giga!
However, if BUD is 28 days, what’s the days supply will be? for example with an 10ml vial, pt inject 1ml q weekly, days supply should be 70 or 28 ???

Yeah, that part gets a little tricky. Technically, if you put on the prescription and directions to discard after 28 days, you are really giving a 28 day supply. If the patient decides to use the vial after 28 days and not get another fill for a few months, thats on them (and this is what usually happens IME). I havent had a patient try to refill the vial every month, (even though they technically could/should), because of cost. If you had a patient that was refilling the 10ml vial every 28 days, and are worried that they are hoarding the 10 ml vials and not discarding them (or worse, diverting them), i suppose there are a few different ways you can handle it:

1) just go back to filling the 1ml vials
2) if the patient is someone you know well and trust, dont worry about it, and fill the 10 ml vial every 28 days, unless a major red flag comes up. You can counsel the patient each time to confirm they discarded the old vial and document just in case.
3) go as far as requiring the patient bring in the old vial and witness them dumping out the remainder of the vial. (This is extreme, and i have never done this, but seems like a reasonable way to handle any concerns on hoarding/diversion and no one can argue you arent doing your due diligence - just remember you should never take a controlled substance back from a patient and dump it for them, have them dump it while you witness it).

 

[Apotheker2015]

I would go with option C, +/- adding a note on the directions to discard remainder after 28 days.

1) you arent violating any federal laws by dispensing greater than a 90 day supply. No knowledge regarding TX law.
2) you are covering yourself regarding the very conservative 28-day rule for multi-use vials
3) you increase access to medication by reducing cost, and increase patient satisfaction without risk to your license

If you truly have concerns about the medical necessity of testosterone for this patient, it doesn't matter if you dispense it in 10ml vials or 1ml vials, i.e. you shouldn't dispense it at all. Otherwise, just dispense the 10ml and make sure you counsel about the 28 day rule and document it somehow.

I've worked with several patients on testosterone therapy (mostly transgender men). There are several pharmacists that are willing to dispense the 10ml without worry. The 1ml vials are truly a pain, and often difficult to get the full dose out of them, especially if someone is doing 0.5ml per dose, because they are not really overfilled much. Additionally, many patients, especially in the trans population who have experienced barriers to care, and straight-up refusal of care, have reasonable anxiety about access to testosterone. Having the 10ml vial provides a little bit of comfort that you wont go without medication for at least the next few months. Just another perspective to keep in mind - the patient isn't always making things difficult just for the sake of being difficult.

That’s an excellent point.

 

[Wickett]

I see.

We must just think differently.
I'd jump at a "get out of jail free card" chance at getting rid of that patient.

1.) It would get rid of what sounds like an dingus patient, and 2.) Restore some credibility for you because it would show the patient was the source of the previous problem.

That's just me, though.

I am just trying to use sdn as a resource to get some perspective on this issue before I dig in and make a decision. My main concern in my job is not to just avoid complaints, but this person is not a typical case. All I can say is they've been a problem patient in the past that has no intention of leaving and have taken incredible, public steps to go against me personally and go after my job if they feel slighted in any way.

It wasn't a typical case of just complaining to corporate. I am just trying to make sure I understand all angles and make the best decision before I have another go around with this person and deal with corporate about it.

 

[Wickett]

No offense, but if your biggest worry is a baseless complaint something is wrong. There are so many reasons not to dispense that 10ml vial, I wish it wasn't even made. Just refuse to stock it and let the patient go somewhere else to get it.

This patient has not been a typical problem patient and they have no intention of leaving. I'm just trying to get all the info I can from people with more experience to protect myself. I don't see anything wrong with getting the opinions of other pharmacists to try and prevent another issue to deal with. And if there is another complaint, so be it, but I want to make sure my reasoning isn't incorrect if I have to defend the decision.

 

[Deja]

Yeah, that part gets a little tricky. Technically, if you put on the prescription and directions to discard after 28 days, you are really giving a 28 day supply. If the patient decides to use the vial after 28 days and not get another fill for a few months, thats on them (and this is what usually happens IME). I havent had a patient try to refill the vial every month, (even though they technically could/should), because of cost. If you had a patient that was refilling the 10ml vial every 28 days, and are worried that they are hoarding the 10 ml vials and not discarding them (or worse, diverting them), i suppose there are a few different ways you can handle it:

1) just go back to filling the 1ml vials
2) if the patient is someone you know well and trust, dont worry about it, and fill the 10 ml vial every 28 days, unless a major red flag comes up. You can counsel the patient each time to confirm they discarded the old vial and document just in case.
3) go as far as requiring the patient bring in the old vial and witness them dumping out the remainder of the vial. (This is extreme, and i have never done this, but seems like a reasonable way to handle any concerns on hoarding/diversion and no one can argue you arent doing your due diligence - just remember you should never take a controlled substance back from a patient and dump it for them, have them dump it while you witness it).

this is all well and good if it's a cash paying patient, but if you are dispensing this through insurance, wouldn't the insurance do an audit and ask why you are dispensing the 10ml vials for 28 days supply when 1ml was enough? since insurance has to reimburse more for the 10ml

 

[BidingMyTime]

LOL, if my opinion or stance on an issue changes or evolves, that's life. I have only been a pharmacist for a couple of years and some change. I don't keep track of who I disagree with or what I have said in the past. Do you?

I only do if they say something beyond the level of belief, ie like saying if you dispense an expired med, that it's OK because it will be good for 1 year after dispensing.

this is all well and good if it's a cash paying patient, but if you are dispensing this through insurance, wouldn't the insurance do an audit and ask why you are dispensing the 10ml vials for 28 days supply when 1ml was enough? since insurance has to reimburse more for the 10ml

Yeah, that would be insurance fraud. This discussion would only be pertinent to cash paying patients.

 

[beautifulrobot]

this is all well and good if it's a cash paying patient, but if you are dispensing this through insurance, wouldn't the insurance do an audit and ask why you are dispensing the 10ml vials for 28 days supply when 1ml was enough? since insurance has to reimburse more for the 10ml

If a person has insurance that will cover testosterone injections, it makes the 10ml vial less justified imho. Although, why would the insurance cover the 10ml vial to begin with? A 10ml vial, per USP guidance, should be discarded after 28 days, and there is no clinically appropriate case in which one individual would need 2000mg (10ml x 200mg/ml) of testosterone in 28 days. and if the patient prefers the 10ml vials (i.e. you arent pushing it on them; in some cases the patient even asks the prescriber to specify on the script to dispense 10ml vial only), and the insurance covers it, where is the fraud?

Eta: i'm not a lawyer, and i dont deal with insurance audits in my work, so i am actually curious if this would be a real issue and if a pharmacist would actually get in trouble with 3rd party payors in this situation?

 

[CetiAlphaFive]

If a person has insurance that will cover testosterone injections, it makes the 10ml vial less justified imho. Although, why would the insurance cover the 10ml vial to begin with? A 10ml vial, per USP guidance, should be discarded after 28 days, and there is no clinically appropriate case in which one individual would need 2000mg (10ml x 200mg/ml) of testosterone in 28 days. and if the patient prefers the 10ml vials (i.e. you arent pushing it on them; in some cases the patient even asks the prescriber to specify on the script to dispense 10ml vial only), and the insurance covers it, where is the fraud?

Eta: i'm not a lawyer, and i dont deal with insurance audits in my work, so i am actually curious if this would be a real issue and if a pharmacist would actually get in trouble with 3rd party payors in this situation?

Just Google "men's health clinic" in any major city.

Be assured each of those clinics is prescribing multiple 10mL vials a day

 

[CetiAlphaFive]

If a person has insurance that will cover testosterone injections, it makes the 10ml vial less justified imho. Although, why would the insurance cover the 10ml vial to begin with? A 10ml vial, per USP guidance, should be discarded after 28 days, and there is no clinically appropriate case in which one individual would need 2000mg (10ml x 200mg/ml) of testosterone in 28 days. and if the patient prefers the 10ml vials (i.e. you arent pushing it on them; in some cases the patient even asks the prescriber to specify on the script to dispense 10ml vial only), and the insurance covers it, where is the fraud?

Eta: i'm not a lawyer, and i dont deal with insurance audits in my work, so i am actually curious if this would be a real issue and if a pharmacist would actually get in trouble with 3rd party payors in this situation?

Just Google "men's health clinic" in any major city.

Be assured each of those clinics is prescribing multiple 10mL vials a day

 

[beautifulrobot]

Just Google "men's health clinic" in any major city.

Be assured each of those clinics is prescribing multiple 10mL vials a day

This is why we can't have nice things.

 

[CetiAlphaFive]

Not sure how I managed this

Double post

 

[Deja]

If a person has insurance that will cover testosterone injections, it makes the 10ml vial less justified imho. Although, why would the insurance cover the 10ml vial to begin with? A 10ml vial, per USP guidance, should be discarded after 28 days, and there is no clinically appropriate case in which one individual would need 2000mg (10ml x 200mg/ml) of testosterone in 28 days. and if the patient prefers the 10ml vials (i.e. you arent pushing it on them; in some cases the patient even asks the prescriber to specify on the script to dispense 10ml vial only), and the insurance covers it, where is the fraud?

Eta: i'm not a lawyer, and i dont deal with insurance audits in my work, so i am actually curious if this would be a real issue and if a pharmacist would actually get in trouble with 3rd party payors in this situation?

well think of it like if its tablets... if the doctor wrote for 90 tabs for 1qd and insurance only pays for 30 days, you can't just dispense 90 tabs and say it's 30 days supply... it would be different if 10ml vial was the only product available but since there is a 1ml vial available, you can't justify in billing for the 10ml vial

 

[beautifulrobot]

well think of it like if its tablets... if the doctor wrote for 90 tabs for 1qd and insurance only pays for 30 days, you can't just dispense 90 tabs and say it's 30 days supply... it would be different if 10ml vial was the only product available but since there is a 1ml vial available, you can't justify in billing for the 10ml vial

The tablets analogy doesn't quite hold, since there is no rule that says that the remainder of the 90 tabs should be discarded after 28 days (as is the case with the 10 ml vial), or concerns that that the 30 day tablets won't actually provide the full doses regardless of how the tablets are split (as the case with the 1 ml vial if someone's dose is less than 1 ml per dose). I agree that things are a bit murky when you bill for 28 days, you say to discard the vial for 28 days, but there is an unspoken understanding that the patient intends to use the vial for greater than 28 days despite the directions for use. And there is obvious waste with dispensing the 10 ml vial as a 28 day supply and instructing to discard the remainder, but in either case, I'm not convinced there is technically anything illegal going on here (not that I am recommending that folks do either, you do what's comfortable for you and follow your org's policies and use your judgement, etc.)