giga

U.S. Public Health Service
10+ Year Member
Aug 23, 2005
768
1,268
On the land and the sea for humanity
Status
Pharmacist
A friend of mine who works in a clinic in MD was telling me about how patients at the clinic are having a more difficult time getting testosterone cypionate 10 ml vials (200 mg/ml) dispensed at community pharmacies, after they've been getting testosterone 10 ml vial prescriptions filled for years without any issues.

Typically, the sig for these prescriptions is inject 200 mg (1 ml) IM every other week or 100 mg (0.5 ml) every week, with a quantity of 10 ml. A 10 ml vial will usually last someone between 4.5 to 5 months.

My friend is saying that the patients are only able to get the 1 ml vials instead of the 10 ml vial, and was asking me what I think is going on. This is concerning to the patients because the multiple 1 ml vials end up being more expensive than one 10 ml vial, as well as those that inject 0.5 ml every week tend to not be able to get full two doses, since there is some medication wasted with each injection and the vials aren't significantly overfilled.

The first obvious reason someone would have an issue getting this filled is insurance day supply limits. But from what my friend is telling me it's not an insurance issue, the pharmacist is just outright refusing to fill with the 10 ml vial, and instead will only dispense 1 ml vials, even if the patient is paying out of pocket.

I am guessing the reason for switching the 10 ml vial to 1 ml vials is because of USP standards that state that a multidose vial's beyond use date is 28 days from the first needle puncture, unless otherwise specified by the manufacturer. Therefore, even though it wouldn't be a violation of the law per se to dispense the 10 ml vial, a reasonable and prudent pharmacist wouldn't dispense a 10 ml vial with instructions to use that vial for beyond 28 days, right?

The thing I don't get and was hoping SDN could help me figure out, is that many of these patients have been getting 10 ml vials for years, and all of a sudden (over the past few months), they are having trouble getting the 10 ml vials. The USP 28-day rule isn't a new thing. Why the sudden change? Anyone know what might be driving this? Is there something else besides sterility concerns that is driving this switch from the 10 ml vial to the 1 ml vial?
 

maria1oh

10+ Year Member
Jul 23, 2009
609
155
Status
I was told to stop ordering the 10 ml vial bc of the 28 day rule. Also day supply not only is an insurance problem but my partner was paranoid of DEA audit for dispensing a 10 ml vial instead of 1 ml vial for day supply purposes even if patient was paying out of pocket.

Also safety is a concern because of accidental overdoses. If a patient is dumb and injects the entire 1ml vial they will likely survive. If they are dumb and inject the 10 ml vial then they could suffer harm.
 
  • Like
Reactions: catalyzt and giga

lord999

Moderator Emeritus
15+ Year Member
Feb 20, 2002
2,736
2,817
DC
Status
Pharmacist, Academic Administration
A friend of mine who works in a clinic in MD was telling me about how patients at the clinic are having a more difficult time getting testosterone cypionate 10 ml vials (200 mg/ml) dispensed at community pharmacies, after they've been getting testosterone 10 ml vial prescriptions filled for years without any issues.

Typically, the sig for these prescriptions is inject 200 mg (1 ml) IM every other week or 100 mg (0.5 ml) every week, with a quantity of 10 ml. A 10 ml vial will usually last someone between 4.5 to 5 months.

My friend is saying that the patients are only able to get the 1 ml vials instead of the 10 ml vial, and was asking me what I think is going on. This is concerning to the patients because the multiple 1 ml vials end up being more expensive than one 10 ml vial, as well as those that inject 0.5 ml every week tend to not be able to get full two doses, since there is some medication wasted with each injection and the vials aren't significantly overfilled.

The first obvious reason someone would have an issue getting this filled is insurance day supply limits. But from what my friend is telling me it's not an insurance issue, the pharmacist is just outright refusing to fill with the 10 ml vial, and instead will only dispense 1 ml vials, even if the patient is paying out of pocket.

I am guessing the reason for switching the 10 ml vial to 1 ml vials is because of USP standards that state that a multidose vial's beyond use date is 28 days from the first needle puncture, unless otherwise specified by the manufacturer. Therefore, even though it wouldn't be a violation of the law per se to dispense the 10 ml vial, a reasonable and prudent pharmacist wouldn't dispense a 10 ml vial with instructions to use that vial for beyond 28 days, right?

The thing I don't get and was hoping SDN could help me figure out, is that many of these patients have been getting 10 ml vials for years, and all of a sudden (over the past few months), they are having trouble getting the 10 ml vials. The USP 28-day rule isn't a new thing. Why the sudden change? Anyone know what might be driving this? Is there something else besides sterility concerns that is driving this switch from the 10 ml vial to the 1 ml vial?
Look no further than your office. FDA CDER and ORA in the last six months are specifically demanding manufacturers to submit their testosterone cyprionate for USP testing (and it outright fails quite a bit because the quality standard is really easy to tell). I actually think this one's going to come off the grandfathered list sooner than later.

http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm310739.htm
 
  • Like
Reactions: giga
OP
giga

giga

U.S. Public Health Service
10+ Year Member
Aug 23, 2005
768
1,268
On the land and the sea for humanity
Status
Pharmacist
Look no further than your office. FDA CDER and ORA in the last six months are specifically demanding manufacturers to submit their testosterone cyprionate for USP testing (and it outright fails quite a bit because the quality standard is really easy to tell). I actually think this one's going to come off the grandfathered list sooner than later.

http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm310739.htm
Damn, and I thought I was a pro at navigating FDA's million different databases... Thanks for pointing this out. I was wondering if FDA was driving this in some way or another...

ETA: granted, these are recalls from compounding pharmacies, not the actual NDA/ANDA manufacturers... so it would be quite a stretch to implicate the manufactured product as well.
 

npage148

Senior Member
10+ Year Member
May 2, 2005
2,023
738
Us
Status
Pharmacist
Yeah, I refuse to full mdv when you run into the 28 day issue esp with controls. If you fill a 10ml vial for 28 days it creates safety, legal and third party issues. Patients who've been getting 10ml vials and using them form months get testy because now they actually need to pay an accurate copay when before they were getting lucky.
 

Dr Wario

Hey you! Want to try this pill?
7+ Year Member
Feb 12, 2011
739
580
Status
Pharmacist
Speaking of testosterone, has anyone else had "addiction specialists" in their area start really pumping out the scripts for this? My local clinic said that newer research has shown that men on long term opiates develop hypogonadism and this is the reason for the increase. I looked into this "research" and while it does appear this can happen, I have seen several patients from this clinic that get their 1ml biweekly injection that are completely jacked, so I am inclined to believe this clinic is just making more money from from a patient population that is already highly predisposed to abuse drugs. Oh and this clinic also pumps out an excessive amount of adderall, I guess they also need that to help them get off the dope right?

Back on topic, I think the sudden switch to the 1ml vials of testosterone is mostly due to availability with reasons that have already been stated above.
 

ldiot

2+ Year Member
Oct 7, 2015
1,619
922
Miami, FL
Status
Resident [Any Field]
It could be the USP 28 day rule but seems just as likely the pharmacy simply didn't have a 10 mL vial on the shelf so handed them the 1 mL vials instead since they had it in stock. I've done this many times.

Also, insurance plans change. They might have been able to get the 10 mL for the last 5 years but that doesn't mean they will be able to get it tomorrow. Patients have a hard time getting things like this through their head so God only knows what kind of crazy story was relayed to the MD.
 

Sine Cura

10 seconds or less
7+ Year Member
Feb 5, 2010
1,995
1,564
Status
Pharmacist
after they've been getting testosterone 10 ml vial prescriptions filled for years without any issues.
Because there's always some ******* pharmacist who failed at their basic job function.

FYI the 1 mL is also multi-dose.

If someone can explain to me why a 10 mL vial is even manfactured, that would be great.
 
  • Like
Reactions: giga

ldiot

2+ Year Member
Oct 7, 2015
1,619
922
Miami, FL
Status
Resident [Any Field]
At the end of the day who cares if they have to pay more most of them don't need it anyways.
 
Last edited:

maria1oh

10+ Year Member
Jul 23, 2009
609
155
Status
While we are on the topic of this do you sell syringes for these patients to go along with their injection or do you require a separate prescription. Then they will claim they lost their syringes and need a few extra. Or they last got it filled 4 months ago but now using mail order or another pharmacy and just need to buy the syringes from you. What size syringe do you recommend if no rx. In several states it is legal to sell syringes without a rx but many pharmacies are against it without a rx.
 

FarmD711

5+ Year Member
Sep 19, 2013
418
238
Status
Pharmacist
For us, the 1 ml had been unavailable for a while so we were dispensing the 10 ml with no more than a 28 day supply and documenting the unavailability of the 1 ml. The 1 ml is available again and we are not able to dispense greater than a 30 day supply of a CIII so there is no reason not to give the 1 ml.


Sent from my iPhone using SDN mobile
 
  • Like
Reactions: catalyzt and giga

wagrxm2000

A different perspective
5+ Year Member
Sep 17, 2014
3,454
1,976
A long time ago I vaguely remember receiving an email from my dm about apparently the board doing an inspection and they checked to make sure all open vials had expiration dates on them. This occurred sometime after starting flu shots.

I could be remembering this wrong though.
 
OP
giga

giga

U.S. Public Health Service
10+ Year Member
Aug 23, 2005
768
1,268
On the land and the sea for humanity
Status
Pharmacist
While we are on the topic of this do you sell syringes for these patients to go along with their injection or do you require a separate prescription. Then they will claim they lost their syringes and need a few extra. Or they last got it filled 4 months ago but now using mail order or another pharmacy and just need to buy the syringes from you. What size syringe do you recommend if no rx. In several states it is legal to sell syringes without a rx but many pharmacies are against it without a rx.
I'm on the pro-harm reduction side, but I really don't want to go off-topic on a huge debate about this issue. To answer your question, back when I worked in retail I would sell syringes to these patients regardless of whether they had a prescription or not. With testosterone injections, we usually recommend patients fill the syringe with a bigger gauge needle (e.g. 21 g), and then switch out the needle to a smaller gauge (e.g. 25 g) to inject. The reason for switching out the needle is because even that one puncture into the vial will dull out the needle. Since the testosterone suspension is quite thick, using a bigger gauge needle makes it easier to fill the syringe. I've known some patients to inject with needles as small as 27 g, which you could probably get away with if you are injecting smaller amounts, such as 0.5ml or less. 23 to 25 g needles are fairly common for injecting. I knew one MD who had all his patients on T injecting with 22 g needles and didn't see anything wrong with that... it's just unnecessarily more painful.
 
  • Like
Reactions: catalyzt
OP
giga

giga

U.S. Public Health Service
10+ Year Member
Aug 23, 2005
768
1,268
On the land and the sea for humanity
Status
Pharmacist
Speaking of testosterone, has anyone else had "addiction specialists" in their area start really pumping out the scripts for this? My local clinic said that newer research has shown that men on long term opiates develop hypogonadism and this is the reason for the increase. I looked into this "research" and while it does appear this can happen, I have seen several patients from this clinic that get their 1ml biweekly injection that are completely jacked, so I am inclined to believe this clinic is just making more money from from a patient population that is already highly predisposed to abuse drugs. Oh and this clinic also pumps out an excessive amount of adderall, I guess they also need that to help them get off the dope right?

Back on topic, I think the sudden switch to the 1ml vials of testosterone is mostly due to availability with reasons that have already been stated above.

When I was at the VA it was actually standard practice to check serum testosterone levels for folks enrolled in the pain management clinic who were on chronic opiates, due to the effects on the hypothalamic-pituitary-gonadal axis. Some of them were prescribed testosterone as a result of having symptoms of hypogonadism + low serum T levels, so I would venture to say this is not uncommon. Not to say that there aren't times where T is overprescribed or inappropriately prescribed, so if you are concerned about it you can call the doctor to do your due diligence to ensure there is a legitimate medical purpose for the prescription.

Also, thanks for your input re: the 10 ml vial issue.
 
Last edited:
  • Like
Reactions: catalyzt
OP
giga

giga

U.S. Public Health Service
10+ Year Member
Aug 23, 2005
768
1,268
On the land and the sea for humanity
Status
Pharmacist
At the end of the day who cares if they have to pay more most of them don't need it anyways.
Is this comment really necessary? Maybe you happen to work down the street from a shady "age reversal" clinic and you see a lot of potentially unnecessary prescriptions for T.... But without additional context, this comment comes off as very presumptuous and unsympathetic.

I know several people who are literally dependent on testosterone / they have complete hypogonadism and aren't able to produce any significant testosterone of their own. For these patients testosterone makes a huge difference in their quality of life and overall health, to the extent that it isn't a stretch to say it is life-saving. I wouldn't wish it upon anyone to have to deal with not being able to produce their own endogenous sex hormones from a young age/their entire life, and the various serious health consequences associated with it (e.g. severe depression, osteoporosis, etc.).

The guys who don't really need testosterone - they usually discontinue it within a few months once they realize what a pain in the a$$ it is to inject it or apply it topically, and that the "benefits" are often overstated. For those who abuse testosterone and other anabolic steroids for bodybuilding and athletics, most of those folks are not getting it from legit pharmacies to begin with.
 
Last edited:

lord999

Moderator Emeritus
15+ Year Member
Feb 20, 2002
2,736
2,817
DC
Status
Pharmacist, Academic Administration
Because there's always some ******* pharmacist who failed at their basic job function.

FYI the 1 mL is also multi-dose.

If someone can explain to me why a 10 mL vial is even manfactured, that would be great.
Look at the 1970s Remington's. The dose used to be a lot higher (like 5-10X higher and weekly think Venice Beach, Miami bodybuilder) but no one figured out the cardiac issues until the 1980s. The DEA put it under scheduling mainly for the abuse issues back in the day.

Why is it today? I'm more cynical, I'll bet Purdue and most manufacturers "know" their real clientele:
http://www.latimes.com/projects/oxycontin-part1/
 

Ackj

10+ Year Member
Nov 25, 2008
2,460
286
Status
Pharmacist
The reason for switching out the needle is because even that one puncture into the vial will dull out the needle.
I learned this a few years ago when we started carrying the prefilled syringes for flu season. The 100% fresh needle is way easier/less pain than one that has had to puncture a vial to withdraw a dose first, even though it is just that one brief puncture.
 
  • Like
Reactions: giga

Niosh

7+ Year Member
Feb 25, 2010
299
182
Iowa
Status
Pharmacist
I learned this a few years ago when we started carrying the prefilled syringes for flu season. The 100% fresh needle is way easier/less pain than one that has had to puncture a vial to withdraw a dose first, even though it is just that one brief puncture.
This is why I've always told diabetics to never re-use needles. This picture shows nicely what happens with re-use. Google image search and you'll find other nice ones.
 

trailerpark

5+ Year Member
May 27, 2013
1,357
745
Status
Pharmacist
To me that picture says you can definitely get 2 uses out of a needle.


Sent from my iPhone using SDN mobile app
 

npage148

Senior Member
10+ Year Member
May 2, 2005
2,023
738
Us
Status
Pharmacist
I do feel a little bad when I use the same needle for zoster. 3 vial punctures and a stab in the arm. The needle feels like it takes a little more muscle to get through the skin
 
  • Like
Reactions: radio frequency

owlegrad

Uncontrollable Sarcasm Machine
Staff member
Administrator
10+ Year Member
Mar 19, 2009
21,900
6,809
Locked in the basement
www.facebook.com
Status
Pharmacist
To me that picture says you can definitely get 2 uses out of a needle.


Sent from my iPhone using SDN mobile app
As long as it isn't your arm, sure.

Sent from my SAMSUNG-SM-G920A using SDN mobile
 
  • Like
Reactions: giga

owlegrad

Uncontrollable Sarcasm Machine
Staff member
Administrator
10+ Year Member
Mar 19, 2009
21,900
6,809
Locked in the basement
www.facebook.com
Status
Pharmacist
I do feel a little bad when I use the same needle for zoster. 3 vial punctures and a stab in the arm. The needle feels like it takes a little more muscle to get through the skin
I always changed the needle.

Sent from my SAMSUNG-SM-G920A using SDN mobile
 

no_future

2020? SERIOUSLY?
Aug 25, 2016
7
5
Status
Pharmacist
Seeing giga and lord999 post in the same thread is a treat. I doubt half of you goobers can fully appreciate that between the two of them there is an infinite amount of pharmaceutical / regulatory knowledge.
 

samuricool

10+ Year Member
Jul 26, 2008
363
84
Status
Pharmacist
It was a couple years ago now but I remember the only 1 ml vials we could get were the brand name depo. I at least would give them the 10 and try to bill the insurance appropriately.


Sent from my iPhone using SDN mobile app
 
  • Like
Reactions: giga