Packaging Practices Represent a Major Waste of Insulin

| Dec 11, 2007

For more than fifty years, I have been a type 1 diabetic. I am writing to bring attention to the fact that huge amounts of insulin are wasted due to the insulin packaging practices of the pharmaceutical industry.

Today, U.S. insulins are packaged either in ten-milliliter vials (each containing 1000 units of U-100) or in three-milliliter pen cartridges (each containing 300 units of U-100 insulin). That's considerably more than many type 1 diabetics (and some type 2s) require. For example, my daily insulin dose is only 20 units (600 units per month).

Since today's fast-acting insulins must be discarded 28 days after opening, my vials still contain more than one-third of their original insulin when I have to throw them out. I also end up wasting nearly 800 units of Lantus (injected at bedtime) every month. And depending upon how many times I use the insulin pen (a great help away from home), there is additional waste.

These packaging practices represent a major waste of insulin, resulting in increased costs not only to the millions of diabetics, but also to third parties such as health insurance companies and government agencies. I recently brought this issue to the attention of the ADA. Here is their response: "The American Diabetes Association does not have a position on insulin packaging by the different pharmaceutical companies. You can voice your concerns…with their customer service departments." I also called the FDA, but have received no reply.

In my opinion, insulin packaging will change only if professional and lay organizations and the FDA jointly bring pressure on the insulin manufacturers. I'm willing to do my part.

William J. Jasper, DDS, MPH
Raleigh, North Carolina

Editor-in-Chief replies: I agree. Let's write to the companies and get after them to cut down on this insulin waste.

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Posted by Anonymous on 11 December 2007

While I agree it would be nice to prepackage insulin specifically to everyone's individual needs, it is highly unlikely that this will be a cost savings to the company or the consumer. People on the pump, for example, may go through 3 or 6 vials of insulin in one month. Selling prepackaged resevoirs or filling each vial/pen with just the right amount of insulin per patient per month might make it easier, but such packaging requires glass (plastic infuses into the insulin after less than a week) and many patients are on a sliding scale with strict insurance requirements that doses match their prescriptions - what if they need more insulin that month due to pregnancy, illness, or holiday meals? If you have a suggestion as to how to make it feasible, please post it. It might be worth the time if you have a plan in mind.

Posted by ricklude on 11 December 2007

I agree with the author that, vials sold to individual users contain more than needed for self medication and much is wasted.

However, the vials are and have been packaged for the treatment of multipule patients. Changing to a smaller size vial with less content, geared to the individual diabetic's usage, will force higher manufacturing costs onto the consumer.

I question if this end result would be worth the extra expence but, still it's a grand idea.

Posted by Anonymous on 11 December 2007

Insulin pens are geared for people such as yourself. Most insurance companies will cover them at the same rate as the vial and you will only be opening 300 units at a time instead of 1000. The Lantus pen is good for 28 days, as are the Apidra, Humalog and Novolog pens I believe (check the package insert) The unopened/unused pens are good in the refrigerator through their expiration date, just as an unopened vial is. Even if you were only on 10 units of Lantus a day, then that 300 unit pen would cause you very little waste. Look into it. I agree that for most type 1 patients a 1000 unit vial seems wasteful, but you wouldn't believe the number of units an average insulin resistant type 2 can go through! Great food for thought, look into alternatives to the vial and I think you will be happier!

Posted by Anonymous on 14 December 2007

As a pump user with a 100+ units per day, I would like the vials 5 times the size! But that too would waste because the providers would not sell as many. What we have now is an OK compromise. In an ideal world none of us would need insulin! In a better world than we have now, pumps would be combined with glucose monitors that we would change once a month. We would fill with u500 and be set. I can dream, but the drug companies would not like it. So we live now!

Posted by Anonymous on 14 December 2007

Even if you don't use an insulin pen, you can ask for the insulin pen vials and access them with syringes the same as with the regular 1000 unit bottle (this is often done by my pediatric patients who are on very low doses of insulin). Remember to follow all the same cleaning & injecting air steps you would do using the bottles.

Posted by Anonymous on 14 December 2007

I've never discarded a single vial of insulin due to the amount of time opened, which is always way over a month, with never a problem. And I've been diabetic for over 40 years. I think this is hype by pharmaceutical cos to get you to buy much more insulin. I bet they don't throw it out in third world countries, either. Just my own opinion/practice. Anyone else doing this? I can't believe I'm the only one.

Posted by Anonymous on 14 December 2007

Type I for over 35 years, my issue is somewhat different. My metabolism has become resistant to Regular insulin. This was resolved with Apidra and frequent bg tests to titrate dosages.

However, lack of health insurance made self-purchase of Apidra cost prohibitive. I use over 1000 units of Regular because of erratic bg's, but local public health care, when available, does not cover Apidra and considers one vial of each insulin (R/NPH) a 30 day supply.

For those who use insulin syringes, choice of syringe can mitigate dosage titration. Experience and an electronic log book has provided better control for me with bolus insulin administered to a half-unit accuracy. Some .30cc syringes are marked with .5 unit ticks. While not a solution to the issue addressed, it does make more effective use of a vial.

To me, the greatest issue is lack of affordable, universal health insurance coverage. This has a much greater economic impact on the individual, family, and society as a whole.

I agree that insulins and other medications could be more flexibly and economically packaged.

The health insurance industry continues to make self-insurance cost prohibitive. Diabetes is clearly a pre-existing ocndition in many cases, and many perople with Diabetes are either wholly excluded or subject to premiums that cannot be met by a large proportion of the uninsurance population.

Let us write not only to the pharmaceutical companies, but also to our Congressional representives and press for an affordable, effective universal health coverage. This is critically important to uninsured people with Diabetes.

Posted by Anonymous on 14 December 2007

I am a pump user who uses 2-3 vials per month. Even as a syringe user in my youth though, I never had to throw out a bottle of insulin. I think I managed to use a whole vial in a month. It's not inconceivable that Type 1 diabetics could be using at least a vial per month. I would say that, while I understand this writer's personal frustrations, he does not necessarily speak for all Type 1 diabetics. There may be a better packaging solution, but I think what we have now is a happy medium.

Posted by Anonymous on 14 December 2007

I agree with the other long time anonymous user -- unless you live in Arizona or somewhere similar without air conditioning in the summer, that silly 28 day rule should be ignored. I've been insulin dependent over 32 years, and have never thrown away a vial because 28 days were up -- although I was diagnosed in Africa and frequently work in the tropics. It is simply an example of the manufacturers protecting themselves from litigation and increasing their sales -- good piece of advice from their point of view, total nonsense for the typical non-brittle diabetic. Check the literature on line on rate of degradation of insulins if exposed to temperatures above 10 but ambient in the US -- the mean is something like 5% loss of potency after 30 days. At your dosage, you've probably got that much measurement error in your syringes anyway. Ignore them!

Posted by Anonymous on 14 December 2007

Not all of us take such small amounts of insulin. I waste none of the 12 vials of Lantus and the 12 vials of Novolog I take each and every month.

Posted by Anonymous on 14 December 2007

I wonder if the 28 day limitation is too restrictive. I have never paid attention to it, and have never had a problem.

Posted by Anonymous on 14 December 2007

It will be a plus plus if manufacturers can extend the 28 day limit to 60 or 90 days.

Posted by Anonymous on 14 December 2007

Have been Type 1 for 26 yrs. Insulin pumper for over 15, and have never discarded a vial of inslin until it is empty.
And it has always been more than 28 days (and my insurance has always covered 100%). I think it's hype.
Firm believer that there will never be cure--big money being made on us, and which company is going to want that to stop?

Posted by Anonymous on 14 December 2007

PLEASE--don't discard your insulin if it is over 28 days old!! I've been injecting and/or using a pump for over 35 years--trust me, if you keep your opened vials in the fridge between uses you can certainly use your insulin vial till it's empty! Try it -- if your BG is truly too high all the time towards the end of the vial, then maybe you can discard. But it will last longer than the suggested "28 days"
Been there--done that!

Posted by Anonymous on 14 December 2007

If I read the information correctly you say you use 600 units a month...that is two vials of 300 units?? I too have gone over the 28 day rule, as do many people I know, and it has not done anything to my control. I think the dates are required by the FDA as a protection for people who might be tempted to keep them for over 2 months. I have a doctor friend who takes and gives his family "outdated" meds He feels that is a waste to toss them when they are fine, belive me they do not toss anything in poorer countries

Posted by Anonymous on 15 December 2007

The manufactuers have tested the viability for only 28 days, or so they say. Therefore, they know it is good for at least that long and this covers their butts, legally. It also allows them to sell a lot more insulin by having the user through away perfectly good insulin to buy more. Many have reported using a vial for 35 to 40 days will no loss of potentcy. With a DDS and a MPH after his name, and 50+ years as a type 1, I can only assume that the DR. is employed in the pharmaceutical industry or has a large investment in Eli Lily.

Posted by Anonymous on 15 December 2007

I have a different gripe! The vials Aventis uses for Lantus are far less sturdy than any other insulin I have ever used. I occasionally drop vials, and several times (maybe three or four times over the last seven years), the Lantus vials have shattered when they hit the floor. This is particularly true when the vials are full. I have never had this happen with Lilly or Novo insulins. Each time it has happened, I have contacted Aventis via email or through their website, and many times they have ignored my complaint. When they haven't done so, they have sent me a whole packet of forms to fill out, and offered to reimburse me for the original out-of pocket cost of the vial that broke, rather than the retail cost of the vial I had to purchase to replace the broken one. My insurance company was also unwilling to provide me with coverage for such a replacement vial. I have ended up not even bothering with all of the paperwork.

I think a company such as Aventis needs to ship a replacement vial to someone who has had such a loss, rather than expecting them to obtain it through the normal channels.

Posted by Anonymous on 15 December 2007

I think Levemir is approved for 42-day storage.

Posted by Anonymous on 15 December 2007

I'm a Type 1 and my little bottle of Lantus contains a 2 month supply. I don't throw that bottle away until I've used every last bit.

Posted by Anonymous on 15 December 2007

Type 1 for 36 years. Now taking Lantus and Humalogue. I keep the insulin refrigerated and do not discard until the bottles are empty - after about 2 1/2 months. I check blood sugars and have never found a problem using the insulin past the '28'days.

Posted by amymercer on 15 December 2007

I agree with the writer, I take about 12 units of lantus and 9 units of humalog each day. I've been type 1 for 23 years and am in very good control. What gets me is that my lantus starts to go bad as I get to the end of the bottle. I live in the south and keep the lantus in my fridge, but every time, when I get to the end of the bottle, it starts to go bad and my blood sugars rise. For $40 a bottle, this is a rip off!

Posted by Anonymous on 16 December 2007

My daughter takes Lantus for Type I Diabetes and everyone I spoke to thinks they should make a smaller vial for children who usually at a young age are taking less than 10 units a night. I don't understand why they don't make a smaller vial and was always wondering if I could go longer than 28 days if I keep it refrigated and the top clean. I was relieved to read that you could but just need to make sure your numbers were still alright. I feel it is so a waste to throw more than half a bottle away every month.

Posted by Anonymous on 17 December 2007

I'm a Type 1 on 7-8 units a day of Lantus. I never throw it out until the cartridge is done. I haven't noticed any rise in BGs after 28 days. I think it's like the shampoo companies telling you to lather, rinse, and repeat. It allows them to sell more product.

Posted by Anonymous on 17 December 2007

In the ADA's latest comprehensive guide they advise you can keep your insulin unrefrigerated after opening for up to 28 days and say if you keep it in the fridge, while using, you should mark when you began - but they don't say you can't use it past 28 days if kept refrigerated. I think it's their way of saying (without legal problems), that you can use insulin past 28 days, just check your blood sugars knowing eventually they will rise when the insulin loses its potency. As a 35 years type 1, on small amounts of insulin, I use my Lantus and Humalog until they run out or I notice my sugar rises, and that's way past 28 days.

Posted by Anonymous on 17 December 2007

A couple of suggestions to the responses:
If you take more than 100 units a day, talk to your doctor or Certified Diabetes Educator about using U-500 insulin, it has 5 times more insulin per unit than the U-100 type of insulin that most of us use. that may cut down on expense as well as the hassle of using such large doses of insulin.

If you use Apidra and it is not covered by your insurance, see if they will cover Humalog or Novolog. Most insurances do and it works the same as Apidra.

Just some suggestions!

Posted by Anonymous on 18 December 2007

I transfer 1/3 to a clean, sterilized used vial using a syringe, and leave the rest in the fridge. Thus I can make a 1000 unit vial last for 3 months.

Posted by Anonymous on 18 December 2007

I work in Manufacturing for a large aerospace company. My first guess would be that the insulin manufacturers know they are wasting insulin or design in some waste factor. furthermore the cost of that wasted insulin is less than the cost of producing more vials/pens with less insulin. It all comes down to money, and though it may appear that there is room for improvement, I would guess the manufacturers are knowingly doing this.
-ken fried
-R&D Aerospace Engineer

Posted by Anonymous on 19 December 2007

I have been type 1 for 20 years and a pump user for 10. I keep my bottles long over the 28 day marker sometime I even have 2 or 3 open at a time and have NEVER had a problem with bad insulin. Don't give into the hype, they just want you to throw, waste and buy more!

Posted by Anonymous on 20 December 2007

Come on, Editor in Chief, you should know better. No one has to discard their insulin after 28 days and DH has run letters in the past disproving this old myth. The 28 day limit in the insert refers to the claim that the manufacturers have only tested it's effectiveness for 28 days and therefore are covering their legal butt by putting 28 days in print. This also allows them to sell a lot more insulin than if they actually tested the full length of viability of an insulin vial or perhaps published the facts that they had already done so and the vial is good for a lot more than 28 days. Many of your readers have written that they were fine using their insulin for 35 or more days.

Your insulin is no longer viable when your testing shows your readings climbing and there is no other plausible reason for that to occur. Of course, don't forget to consider pizza's, pastas, turkeys and any other food which will raise your readings for a day or two. This could be 20 days, 30, 40 or more. I've gone 39 days on a vial with no loss of effectiveness. If insulin freezes or is overheated, it's potency will drop drastically in hours or days. Properly maintained, and that does not require constant refrigeration, the vial should be good until it is empty; for most diabetics. Testing is the only sure proof of a problem with the insulin although discoloration should hint that there may be a problem developing. You can send a vial back to the manufacturer through your pharmacy if you are having a problem and they will do an in depth analysis as to what occurred with the vial. You will get a call or a letter telling you what they found and what they suspect caused the problem so you can prevent the problem from reoccurring.

Dr. Jasper apparently has some medical background and should know enough to do a little research before accepting pharmaceutical company claims and going off on his crusade. (See Exubera) And while he may personally prefer smaller packaging, I don't think he should be the spokes person for all diabetics. I would imagine most diabetics don't want to pay more in co-pays for the same amount of insulin and many would like to see more insulin available for the same co-pay. He can always go to an insulin pen if he wants to get less insulin for the same co-pay, and the pen seems to meet his requirements without costing the rest of us more money. Finally, with a DDS and a MPH after his name, I can only assume he knows the facts and is acting as a shill for the pharmaceutical industry; or at the least has a substantial stock investment in Aventis and Eli Lily.

Ted Martin
Iselin, NJ

Posted by Anonymous on 20 December 2007

I've been Type 1 since age 11; 40 years--pumping since 2004. I use a vial of insulin unrefrigerated until it runs out. I fill my reservoir w/ 250-300 units and keep my infusion set in for 7 days instead of the recommended 3. I test several times a day and change lancets maybe twice a YEAR. I've had only two storage problems: old Ketostix giving false results (remedied by buying foil-wrapped) and concentrated, white crystal-floating insulin used w/ a jet injector (The top of the vial adapter always broke and wouldn't seal well).

If they start changing vial sizes, THEY will charge the same ridiculous amount of money. Humulin is such a ripoff and way inferior to beef/pork (give me lows I can recognize!).

Posted by Anonymous on 30 December 2007

I have Type 1. I only take 24 units of Lantus daily. I do toss the vial the 1st of every month.. which is 30-31 days. I keep thinking, lets try it longer and see what happens. I sure will do that the month of January. WHAT A WASTE. I use Novalog, about 16-20 units daily. I keep that vial for about two months. I have been using the cartridges of Novalog since this summer, when it is empty I toss it. Has some savings. I am lucky and have good insurance that will give me a bottle of each for each month. But for those without insurance it sure does add up.

Posted by Doreen Taylor on 31 December 2007

I have had Type 1 for 33 years. Using insulin pump since 1999. I have never thrown out any insulin and have reused syringes and lancets a number of times. I also keep my open bottle of insulin currently using at room temperature for less bubbles and comfort. My last A1C was 5.4%. Pharmacies are just trying to make more money.

Posted by chickadee410 on 2 January 2008

I have had Type 1 diabetes for 40 years, and my dog has had diabetes for 1.5 years. I never throw our insulin out. I have always used it until completely gone. I have never had any problems, and it saves me money.

Posted by Anonymous on 10 January 2008

Use a pen. 3 ml vial only lasts a couple of weeks, then use a syringe to suck the last remaining drops out of the vial before discarding it. Or if you are anti pen, just use the penfill cartridge with a syringe.

The only insulin I have in a big vial is the lantus, and I make that last as long as possible. After about a month and a half I do notice a drop in potency... but that's a full two weeks past the 28 day rule. As soon as I notice the change I discard the bottle.

Posted by Anonymous on 1 February 2008

Perhaps a fair way would be to charge according to ordered dosage ie 20 units x 28 days or per unit rather than charging the patient according to the containers available doses

Posted by Seymour on 23 May 2008

I have been taking Types "R" and "N" in a combined dose and have not noticed any change in strength after any amount of time. A question that comes to mind to me is, "Why do so many types expire in exactly 28 days"? Of course the answer is that 28 days is a convienent amount of time to put on the label. That way, you feel like you are squeezing out a couple of extra days from each bottle and still throw away some good insulin each month. Type "R" for me runs about 42 days per 1000 unit bottle.

One place that Lily can reduce some cost is the size of the package that they recently switched to. That package is larger and does not fit in the containers that I store my unopened bottles in. Aggravating.

Posted by Anonymous on 5 June 2008

I know from experience that Novolog seems to last almost forever, and I switched from Lantus to Levemir *specifically* because it is more stable (it's protraction mechanism is based on a fatty acid side chain and reversible albumin binding in the blood, rather than the solution's pH)

I am adult-onset Type 1, use cartridges with needles (which allows me half-unit dosing and quarter-unit estimation), and use 1-2 units Novolog per meal, and 10 units Levemir per day (split dose). I also eat a diet similar to that which Dr. Bernstein recommends - which is why I am able get away with such small insulin usage, maintain near non-diabetic blood sugar (75-85), and may still be honeymooning after two and a half years.

Posted by Anonymous on 4 July 2008

Before I started puming I kept my Lantus bottles in a baby sock so they would not break if dropped.

I regularly use open vials of insulin (Novolog) until 45 days or more until gone with no problems.

Posted by Anonymous on 18 July 2008

Why nin this day are do you continue to use Vial & syringe when pens are portable going with you whenever you need them without refrigeration . Co-pays in most case are the same for pens and vials. Levemir in a FlexPen is good for 42days NovoLog in a Flexpen 30 days and NovoLog Mix 70/30 - 15 days these time frames eliminate waste .

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