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Insulin
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Diabetes
Trust
.
Looking after your Insulin and Injection devices
It is over 75 years since the discovery of insulin and there is now a variety of insulins available, all of which are highly purified. It is important that the insulin we use is safe and effective so that the insulin itself is not responsible for varying blood glucose levels.
FACT – Insulin is a powder that is mixed in solution and once in solution it breaks down slowly into insulin transformation products [ITPs].
FACT – There is a slow rate of breakdown or transformation when insulin is stored in the refrigerator at 4 degrees C.
FACT – This breakdown is accelerated by exposure to light, heat and agitation or regular shaking.
FACT – Increasing the purity of insulin reduces its stability.
General Rules
· To ensure that your insulin remains effective, stable and undamaged you should discard your ‘in use’ insulin after 28days, whether in a vial or cartridge.
· Insulin that is not in use should be stored in the refrigerator. If refrigeration is not possible, it can be kept at room temperature [15-25 C] for 28 days.
· The in use vial may be kept at room temperature [15-25 C] for 28 days.
· In use cartridges should be kept at room temperature and SHOULD NOT be kept in the refrigerator.
· Insulin has a ‘use by’ date as well as an expiry date.
The advice about storing insulin may differ from one manufacturer to another and so we have obtained information from the various companies:
CP Pharmaceuticals Ltd – manufacturers of natural pork and beef insulins:
"Our recommendation is that a single vial may be used repeatedly over a 3 month period, as long as the vial is maintained at the correct storage temperature of 2 to 8 degrees C.
If the vial is stored outside the refrigerator [at room temperature] then this period of use should be reduced to 28 days. This also assumes that the vials are appropriately stored and are used under normal conditions [that is to avoid microbial contamination]. Insulin in cartridges is stable for up to 4 weeks once open if stored at 25 degrees C. We do not recommend that ‘in use’ cartridges are stored in the refrigerator."
Novo Nordisk Pharmaceuticals Ltd – manufacturers of pork and synthetic insulins, 'human' and analogues
"Our unopened insulins are stable until the expiry date if stored in a refrigerator. Once open vialled insulin is stable for up to 3 months in the refrigerator and 6 weeks at 25 degrees C. Insulin in cartridges is stable for up to 4 weeks once opened if stored at 25 degrees C; we do not recommend that in use cartridges are stored in the refrigerator. Brief exposure to temperature extremes need not necessarily reduce its efficacy. Our guidelines are quite cautious and are a guide so that people can be aware that should these restrictions be exceeded there is a strong likelihood that their insulin may be damaged and they should consider discarding it.
This table with permitted temperature and exposure times applies to single exposures only and repeated exposures to higher temperatures will gradually reduce the efficacy of the insulin. It shows permitted temperature and exposure times that will not reduce the efficacy of the insulin, PROVIDED it is then returned to the refrigerator.’
Permitted Exposure Times For Various Temperature Ranges
· Insulin preparations should not be exposed to temperatures between:
· -20 to –10 degees C for more than 15 minutes
· -10 to –5 degrees C for more than 30 minutes
· -5 to +2 degrees C for more than 2 hours
· 8 to 15 degrees C for more than 96 hours
· 15 to 30 degrees C for more than 48 hours
· 30 to 40 degrees C for more than 6 hours
· Insulin should never be stored above 40 degrees C.
· It is important that insulin is never frozen, or exposed to a combination of high temperatures and excessive vibration.
Table provided by Novo Nordisk
Eli Lilly – Manufacturers of synthetic insulins [‘human’ and anaolgues] in the UK and pork insulin in some countries
‘Our Humulin range has regulatory approval for in-use out of the fridge for 28 days. We have also performed our own in-house studies, however these were also completed after 28 days. Therefore, we do not have any data on in-use of Humulin vials after 28 days and thus, although we have no information to suggest that there is any problem with in-use vials stored in the fridge after 28 days, without data to support this we currently can only recommend in-use for 28 days.’
WARNING!
PATIENTS SHOULD ALWAYS DISCARD THEIR ‘IN USE’ insulins AFTER 28 DAYS AS A NECESSARY PRECAUTION
Why is this important?
There are no insulins that mimic the human body’s production of insulin in response to food intake. Diabetes is not an easy condition to live with and people with diabetes are individuals with different hormonal and metabolic rates. Each person responds to insulin in different ways.
There are many variables that affect diabetic control, such as:
· Diet and exercise
· Lifestyle
· Fears of low blood sugars [hypoglycaemia]
· Emotions and stress
Diabetes will remain a difficult and complex condition until we are provided with better ‘tools’ with which to control it. Until then it is important that we rule out anything which could affect our diabetic control. This must include ruling out the possibility that our insulin has started to break down so that it is less potent. This results in it being absorbed and moved around the body differently, so affecting blood glucose levels.
It is also important to realise that if we have been using ‘old’ insulin that has gone off, with a change to a new fresh fully effective vial there is a greater chance of a severe hypo at the changeover time.
REALITY!
How long do people use their insulin?
A study carried out in 1991 showed that people used a vial of insulin for about 4 to 13 weeks.
IDDT asked 40 people how they stored their insulins before and after opening the vials:
· The vast majority of them stored their unopened insulin in the fridge and 75% of them kept their opened insulin out of the fridge.
· The majority used their short acting insulin in less than 4 weeks but they used their longer acting insulin for 6 to 12 weeks and most of them kept it out of the fridge.
· Almost everyone used their insulin down to the very last drop and only one person had been told by their doctor to discard their insulin after 28 days.
Insulin
pens dribble from the tip of the needle.
The 3.0ml pens dribble more than1.5ml pens
With the introduction of the larger 3.0ml pens and the withdrawal of some of the smaller 1.5ml pens, a study [ref1] compared 6 pens of both sizes and provides useful information to ensure that you receive the intended dose of insulin.
The pens used were Lilly Pen 3.0ml, B-D pen 3.0ml, NovoLet 1.5 and 3.0ml, NovoPen 1.5 and 3.0ml. The study involved 20 people who injected sterile saline and the needle was withdrawn after 1, 3, 5 or 7 seconds respectively. Any dribble was collected on filter paper and weighed.
Results showed:
There was minimum of dribbling from the 1.5ml pens.
· 8 out of 20 NovoPen 3.0ml and B-D 3.0ml pens, 16 out of 20 NovoLet 3.0ml and 19 out of 20 Lilly 3.0ml pens dribbled after a 7second hold-in time.
· The different brands of pen dribbled different amounts with the B-D 3.0ml leaking the least followed by the NovoPen 3.0ml, the Novolet 3.0ml and the Lilly Saline Pen 3.0ml leaking the most, at nearly twice that of the Novolet.
Recommendation - hold in time of at least 10 seconds
As a result of the great number of leakages from 3.0ml pens even after 7
seconds, the researchers recommend a hold-in time of at least 10
seconds. They also point out that with 1.5ml pens where the leakage is
minimal, the risk of dribbling was not a major issue. Then the hold-in
time was only considered because of the risk of the insulin leaking from
the skin or blood being drawn back into the cartridge.
Note: none of the pen manufacturers recommend such a long hold-time for their 3.0ml pens – Novo Nordisk recommend 6 secs for both NovoPen and NovoLet, Lilly recommend 5 secs and BD do not mention hold-time.
Why is leakage important?
If you receive different amounts of insulin each time depending on
hold-in time, then this might lead to unstable blood glucose levels
especially as there are other factors that could influence the amount of
insulin actually injected.
Air bubbles - BD recommends the discharge into the air of 4units of insulin and thereafter 2units until a drop of insulin is seen at the tip of the needle. Lilly recommends discharging 2units before every injection. The information for the NovoPen 3.0ml is that 2units are discharged before every injection.
Needle replacement - loss of insulin and air bubbles. All 3 of these manufacturers recommend that the needle is removed after every injection but for different reasons!
· Novo Nordisk’s reason is ‘to avoid liquid leak’ [NovoLet]
· Lilly’s is ‘to avoid air entering the vial’ [Pre-filled pen1999], to avoid needle blockage and to keep sterility [Humalog pen package]
· BD’s reason is ‘’maximum safety and comfort’.
Pens have to be reliable and it seems that the 3.0ml pens have the disadvantage of insulin loss due to dribbling that is not a problem with 1.5ml pens. So hold-in time, dribbling and air bubbles could result in different amounts of insulin being injected and poorer blood sugar control.
Ref 1 Practical Diabetes, June 2000, Vol 17, No 4
There are many phobias that affect people and there is a small number of adults and children who have needle phobia – a fear of needles. This is a very real problem as it is a great deal more than just ‘not liking injections’ and of course becomes a very important problem if someone with needle phobia develops diabetes that requires insulin treatment.
· Needle phobia may affect treatment and/or diabetic control by adults and children "forgetting" injections, omitting injections and blood tests or refusing to go on to a multi-dose regime because it means even more injections.
· It is important that needle phobia is recognised as a very real problem and that assumptions are not made that the child, teenager or adult is just being ‘non-compliant’ and ‘not doing what they should’.
Is there a connection between needle phobia and injection pain?
Research carried out in Denmark (ref1) used questionnaires to ask 158
children and adolescents with diabetes about injection pain and needle
phobia. While the study concluded that most children and adolescents
experience only slight pain when injecting for some pain and needle
phobia are major problems.
The results were as follows:
Injection pain
· Pain with blood tests was significantly greater than with all types of injection devices.
· Younger children found both injections and blood testing more painful than older children.
· At the age of 14-18 years some still defined injection pain as unbearable.
· Pen users found only slightly lower pain than those using syringes even though they had twice as many injections. But those who had recent experience of both pens and syringes indicated significantly less pain with pens. However, when the research was carried out the fine needles that were available for pens were not available for syringes.
Needle Phobia
8.3% of those between 6 and 19 years classed themselves as having
pronounced needle phobia. However this group showed:
· that all family members had a more negative attitude towards diabetes
· 16.8% of mothers and 17.6% of fathers classed themselves as having pronounced needle phobia
· 9 of the 13 children with needle phobia had fewer than 5 years experience of diabetes.
Relationship between needle phobia, injection pain and diabetic control as measure by HbA1c levels
The study demonstrated a clear relationship between injection pain and HbA1c levels, those with injection pain had ‘poorer’ HbA1cs. There was also a clear relationship between needle phobia and injection pain, blood testing pain, patients’ attitude towards diabetes and their mood at the time.
Ref 1 Experiences of pain from injections and needle phobia in young patients with IDDM. Practical Diabetes July 1997, Vol 14: No 4
Note: We still know very little about the effects of self-inflicted pain on children, teenagers and adults. It is an area worthy of further research.
The mhi-500 needle-free injection system – is an alternative to pens or syringes for injections and is a useful device for people with needle phobia. It works by forcing a fine stream of insulin at high speed through a precision engineered nozzle.
This device from The Medical House Group has now been approved for use by people with diabetes on an NHS prescription. The device will be sold to the NHS at a similar price as has been charged privately – around £120 for the device and £20 a quarter for the nozzles.
For more information there is a freephone helpline: 0800 917 7328 or visit www.insulinjet.com
The J-Tip Injector - this is a needle-free injection that delivers the insulin, or any other medication to be injected, under pressure from a gas cartridge. The J-Tip Needle Free Syringe is 10cms long and weighs only 9 grams. Only the base tip of the device touches the skin. The gas is released by pressing a trigger and this drives the plunger that pushes a piston and the insulin from the sterile syringe through the skin. According to the manufacturers, the insulin is forced through a very tiny hole at high speed in a fraction of a second. The manufacturers also advise that the J-Tip Injector dispenses the medication uniformly in a spray pattern in the subcutaneous tissue [skin] and the rate of absorption is faster due to the increased surface are of the fluid and this has implications for diabetic control because the insulin will work faster.
Injection with a needle in the normal way leaves a pool of insulin under the skin and this takes longer to disperse and absorb.
Warnings:
· The product data sheet warns that this device should be sold under the direction or order from a physician.
· That you should consult your doctor about suitable injection sites and that injection sites should be where there is as much fatty tissue as possible.
· That there have been reports of local reactions such as skin irritation, hardening of the skin, bruising and bleeding.
Note: IDDT is not endorsing the J-Tip device but we are advising of its availability
The J-Tip is not available on the NHS and the costs are:
· In the UK £93.00
· To Europe £98.00
· To all other destinations £89.00
The details of the J-Tip Needle Free syringe can be obtained from:
M. Devices Group,
Marlborough House,
Riding Street,
Southport,
PR8 1ERW
UK
Telephone (+44) 01704 544 944
Or by visiting the website at
http://www.merseyworld.com/bennetts/mdg/jtip1.htm