Anne-MarieSupporting arguments for better rulings around oral corticosteroids for patients who need replacement therapy. Please pass on and consider carefully.
RE: My previous contact regarding Access Exemption Cirteria and also cost of ongoing replacement therapy in Adrenally Insufficient in New Zealand where Pharamceutucal Rulings are concerned:
I would like to show you two other medical conditions within patients here and their drug supplies in New Zealand and ongoing care etc. Firsty two that are more common than Congenital Adrenal Hyperplasia and are treated at home by patients are Insulin Dependant Diabetes and also Asthma.
People with Diabetes (Insulin Dependant)
They depend on replacement insulin to control their diabetic state or otherwise they may have a coma and die. They don’t make insulin.
My brother in law has insulin dependant diabetes and gets his scripts for insulin on a monthly basis I presume due to the nature of the insulin and it’s shelf life only. This is because insulin needs to be fresh I presume and the storage life of such is not as lengthy as tablets in a jar which can last anything up to 12 months if stored correctly.Some facts about Insulin:
Insulin vials approximately a month at room temperature (defined as 59 to 86 degrees F, according to Lilly).
In hot climates, try to keep insulin in a cool pack or in a chilled thermos, if there’s no refrigerator. Keep insulin out of direct sun and light. Remember: Never freeze insulin, and don’t store insulin directly against ice.
Even if insulin loses some potency in heat, you can prevent further de-strengthening by keeping the insulin chilled. Rechilling does not restore the insulin to original potency, one manufacturer warns. If your insulin loses strength, other factors may also affect your blood sugars. If you increase activity levels during travel, your insulin sensitivity may increase; if your insulin loses potency, your increased activity level may or may not compensate for the decrease in potency. Monitoring is important, obviously, to track these unknowns. Talk with your care provider about how to manage these issues.Microbrial Growth
According to manufacturers, possible microbrial growth warrants disposing insulin when the given shelf life expires. “Air introduced to the vial, for example, may contribute to microbrial growth” because air isn’t absolutely clean. Also, shelf life of some disposable insulin pens and cartridges (for reusable pens) is shorter than the shelf life stated for vials. Shelf life may depend on factors such as the insulin type and size of cartridge/disposable pen (3 mL vs. 1.5 mL). Vials, as a rule, are reported to keep about a month at room temperature (defined as 59 to 86 degrees F, according to Lilly’s standards). Cartridges for reusable pens, as well as disposable pens, may have a shelf life of a week or two, depending on the insulin type. Note that Eli Lilly states not to refrigerate its disposable Humalog Pen, Humulin NPH Pen or Humulin 70/30 Pen though pens with cartridges may be stored.
Shelf Life
Manufacturers’ stated shelf life of insulin when stored at room temperature:
Vials
Lilly R 28 days Lilly N 28 days Lilly 70/30 28 days Lilly Humalog 28 days
Novolin R 30 days Novolin N 30 days Novolin 70/30 30 days
Cartridges for Re-usable Pens
1.5 mL
Novolin R 30 days Novolin N 7 days Novolin 70/30 7 days
Lilly R 28 days Lilly N 7 days Lilly 70/30 7 days Lilly Humalog 28 days
3 mL
Novolin R 28 days Novolin N 14 days Novolin 70/30 10 days
Disposable Pens
3 mL
Lilly N 14 days Lilly 70/30 10 days Lilly Humalog 28 days
Proper storage of insulin is paramount, to avoid contamination and loss of potency that could affect your dosage levels. In extremely hot or cold or hot climates, you need to be even more careful to protect your insulin supply.They also have to inject the insulin, whereas with tablets for corticosteroid replacement, these can be taken orally for example. So the only reason that a diabetic may pick their script up monthly, is the fact that it is safety wise much better to get fresher supplies. Keeping stores of this for longer could mean problems due to it’s liquid state.
The next Medical condition I am going to bring to your attention which is very common in children is asthma. I derived information from this site here:
I note that asthma is treated with both a reliever and a preventer. The preventer has corticosteroid within it which can be inhaled up to 2-3 times per day at som many puffs. The reliever is not usually used unless there is an asthma spell.
Many children suffer asthma, and take steroids in this way on a daily basis to prevent asthma attacks. For this reason, they are allowed to be scripted up to 5 inhalers POS. I presume POS means something like "Period of Script" does it? Period of script being three monthly in most cases. If not what does this mean?
From my understanding asthma is not in anyway as serious as adrenal insufficiency in the sense that a child who does not make ANY cortisol at all, has a distinct disadvantage over a child that can perhaps make cortisol normally but just needs the steroid within an inhaler to prevent an asthma attack. Or that asthma attacks without such an inhaler, would not be quite as frequent or serious as if a child who is on "TOTAL REPLACEMENT CORTICOID THERAPY" would endure.
So we have a child who could theoretically do without a days doses of inhaler, and at the very least, if they have an asthma attack, they are still not quite at the same level of risk as a child missing a days worth of replacement corticosteroid because their medications ran out and the pharmacy was not open to collect the next months supply? This is how I perceive this as a parent anyway. So therefore I read that a child with a lesser medical problem than my son with adrenal insifficiency (or even if considered "similar"in seriousness-the point is my sons is no less important where medications are concerned) allowed to have UP TO five inhalers in anyone three monthly period which are at the cost of $3 in total for that.
However on the other hand my child is only scripted what his body would require on normal healthy days, and even though the physcian KNOWS he could possibly need more at some point within that three months period if he get’s ill or sick, he ignores this fact and does not account for it. By now you will see that he has accounted for a child with asthma if sensible and can script up to five inhalers in one script period. However, knowing full well my childs inability to even make the stuff, due to the system and what he writes on the script, if my child becomes ill, I am not as fortunate as the asthmatic parent, because I only have the small daily amount the Doctor scripted for healthy days.
I know someone will put forth a point of view about Diabetes at this point. that fi they should have to collect supplies of their med’s on a monthly basis--why shouldn’t my son? There are two answers to this.
1./ A diabetic will I presume only NEED the insulin he has been prescribed throughout the whole three month period. Therefore what is at the pharmacy, will NOT need to be increased upon. Therefore the diabetic ONLY pays $3 for the whole script period.
2./ The ONLY reason that a diabetic is possibly allowed to collect the insulin on at monthly intervals is due to the shelf life which is illustrated above.
Therefore there is a definate discrimination against people with adrenal insufficency where the Pharmac rulings are concerned and the necessary drugs to treat such. Here they are outlined:
1./ That a person who is adrenally insufficient and whose needs can change where their cortisol replacement needs are concerned can change from time to time at ANY given point within a 3 monthly script period and that THIS possibility for change is NOT catered for in the way that an asthmatic is catered for. Given that inhalers have a shelf life of over 12 months and tablets such as hydrocortisone are NO different, then this is not satisfactory. Tablets can be stored for over 12 months if kept cool and dry and at the right temperature. All that is needed therefore is education where the patient is concerned in this. It is NOT a viable reason to deprive a person who is dependant upon such drugs of having them in advance and having an adequate supply ABOVE their normal daily needs for cases where they may be ill within a given script period. They should have the same rights where medication is concerned applied to them as an asthmatic at the very least.
2./ These tablets in the 5mg hydrocortisone tablet form are supplied in bottles of 100 tablets by Douglas pharmaceuticals. They are also in the process of making 1mg tablets which I presume will also be supplied in 100 tablets or thereabouts. On average my child needs 90 tablets for a months period if he is well and just needing normal every day cortisol replacement. However, if he is sick for a week and I double, he will go through that bottle much faster. Much the same as an asthmatic will use their inhalers more frequently and use them up. The difference being that there is not a possibility that my child with adrenal insufficiency can do without HIS tablets.
his florinef has never changed throughout his life. He has always had 1 100mcg tablet per day and this has never changed EVEN when ill. Therefore, a three month script of florinef will last three months without a doubt. However, a three month script of 90 tablets each month where hydrocortisone is concerned may and may not.That an asthmatic can be prescribed his inhalers by quantity x5 irregardless as to whether he uses them all or not though IS a concern and I feel is discriminatory towards others on steroids for MUCH more serious reasons here. Someone should be taking into consideration what my sons possible needs are here. If an asthmatic does not use ALL those inhalers, they dispose of them. So why are we not allowed the same privelage here? If my son does not use up an excess of tablets, I am quite intelligent enough to note the shelf life and dispose as necessary.
3./ I guess someone could say, "Well of your child is sick, you need to see a Doctor."
My answer to that is:
So why is it that diabetes and asthma would be allowed to be managed at home when a child has more frequent episodes of illness than my child? They just use an inhaler or take a little extra glucose or are managed at home--no problem most of the time. Unless THEY have problems that complicate their asthma or diabetes, THEY don’t need to see a GP either! We do not need to see a GP unless we are in doubt about something or the child is ill and needs another drug or treatment as an aside from the cortisol. However, because of unfair rulings around drug supplies, we are being forced to pick up scripts and PAY extra for them. This is not acceptable when we should have had our needs anticipated for as an asthmatic does have within any given period. I take this as complete discrimination towards me as a parent that is educated in how to deal with my son when sick BY the Endo and leaflets and booklet’s, but not having this taken into consideration medicine wise by Pharmac’s rules . Our Doctor’s obviously cannot write on the script,"90 tablets per month or 6.75mg/3.75mg/5mg=15mg per day and MORE as per directed" can they? Yet we are given distinct instructions from that Endo and our family GP is absolutely NOT needed unless there are complications or we don;t understand the protcol for treating our children with adrenal insufficency. Given instructions by an Endo, and then expected to go to a GP JUST because there is no system in place where my son has been scripted the extra medication my sons Endo recommends if he is sick between one three monthly appointment and the next, I therefore have to pay MORE than the average parent with an asthmatic child and a diabetic child in this sense.
I would like to have someone read through and put this before the panel for discussion please. It seriously needs to be looked at and a better solution for us as parents. I would also like to have the right to self exempt under the "Access Exemption Criteria" on such occasions that my Doctor omits to sign such a script "Certified Exempt" as is often the case. I am SURE you all know that it is NOT our positions as parents or patients to tell a Doctor what to write on a script and we SHOULD not be put in that position where it concerns life dependany on these drugs. You can easily direct such exemptions genuinly to patients who are ONLY on these medicines for a 6 month period and beyond. This is because ANYONE that is on steroid for that length of time is in the same boat as an adrenally insufficent patient and is just as dependant upon them. Others that are on them temporarily are often weaned off. They only have ahsort time on them and therefore may not use the whole three months they have been given at anyone time. However, someone with adrenal insufficiency will NEVER not have a need for their medication and will NEVER end up with a surplus. Therefore you are NOT losing anwhere as they will eventually use up what surplus they DO have when things change for them where their cortisol needs differ from time to time.
I get the impression that a lot of the rulings is to prevent unneccesary dispensing of subsidised drugs that sit around in someone smedical cabinet and have been paid for therefore by the goverment and not used. this is not the case for people with adrenal insufficnecy that need steroids and there is absolutely NO reason why they should not be able to exempt themselves in the circumstances. The drugs have a long shelf life. They will ALWAYS need them and extra supplies for National emergencies (such as an erth quake---did you know that we have 14’000 tremors or earthquakes per year in New Zealand and which one is going to be the biggie? No one knows!) or illness. Please therefore look at this matter fairly and act.
Regards
Anne-Marie Jefferies
www.cahsupportforum.com
anne@cahsupportforum.com