Pharmac meters and test strips

Diabetes Youth New Zealand PO Box 67 – 041 Mt Eden Auckland Natalie Davis Therapeutic Group Manager PHARMAC PO Box 10 254 Wellington 6143 Diabetes Youth New Zealand (DYNZ) represents children and young people up to the age of 18 years and their families living with diabetes. DYNZ is closely affiliated with Diabetes New Zealand, and the DYNZ President sits on the DNZ National Board. At present we estimate there are 3000 patients with diabetes under 18; exact figures are hard to verify as there is no national register. Though this patient group only amounts to approximately 1.5% of the total number of people with diabetes in New Zealand, we know that this group consumes a disproportionately large percentage of the annual and long-term pharmaceutical spend due to the type of treatment they receive (multiple daily injections and pump therapy, and frequent blood glucose testing) and the lifelong nature of the condition. Young patients with diabetes are not able to manage their condition alone, and the condition is life threatening on a daily, if not hourly basis. A heavy workload is placed on Mum, Dad and siblings to care for the patients with diabetes. Included in this are Grandparents, extended family members, sports coaches, school nurses, teachers, parents of the children’s friends, after-school activity carers. All of these people have been trained in caring for the young people, they all have access to written instructions concerning EMERGENCY PROCEDURES and are trained to manage that particular individuals medical needs. It may look like simple economics to change out the supply of some meters for a new one, but the knock-on effect to these families is very significant. In this case it is not a situation of one size fits all, there are many variables in diabetes as a condition, and what works for one, will not work for another. If your proposal to replace current meters with the CareSens meter is confirmed, most of our
members and their support networks will be required to make significant changes (see Appendix
1: SAFETY ISSUES and GENERAL CONCERNS).
The strain and stress that families live with 24/7 for years is immense and many families do not cope. We believe that the change you are proposing will increase the stress due to the increased risks associated with the sole supplier arrangement and with the logistics of actually re- training all of the networks and changing all of the Instruction sheets that each family has distributed to these networks. Most families have in excess of 3 meters in operation at any one time. One in the medical kit that is carried everywhere with the young person, one in the car and one in the school office. This is because these meters are an integral part of keeping these children alive. Young people suffer many more life threatening hypoglycaemic episodes than the rest of the population. This is because their regimes are constantly changing due to their growth and development, their daily schedules are less stable and illness associated with their young age. Patients have self-funded these multiple meters as they are considered essential safety devices not a ‘nice to have’ extra device. When they experience a hypoglyceamic episode a child or young person is unable to help themselves and potentially facing a life threatening situation. This is why everyone around them needs to be trained and have access to the instructions. It is essential that our families have their safety protected as they are a particularly sensitive and vulnerable section of New Zealand society. Children diagnosed with diabetes have a life-long condition with the reality that they will face long term complications. The aim is to minimise these complications by the use of correct safety devices that suit the patient’s needs and minimise the cost of their future medical care. Families are very well aware of the long term risks their children face. They know that even if they take extreme care of their children, they will in the end face health issues because of the Diabetes. This is why many families have chosen to borrow money or appeal to the charity of others to help to purchase unfunded pumps, consumables and unfunded extra meters. Just as the young patient has a network supporting them, the families in turn have their own network. This involves organisations like ours, DNZ, Medical Practitioners and specialist nurses, charitable organisations along with the extra services that pharmaceutical companies provide free to families. The network has benefited from the increasing competitive market environment over recent years in that we have seen a greater range of devices and medicines introduced into the market to better meet individual needs. Diabetes may be just one of many issues that our children and young people are facing, and the reality is that a child with dyslexia and diabetes on a pump uses a meter that minimises the risks of that child transposing a number and entering incorrect life threatening information. A child with failing eyesight needs a backlight in order to read the meter, as does a parent routinely testing their child in the middle of the night. The reality of this proposed sole supplier arrangement is that the children and young people will face increased risks to their lives and that the present support networks to both them and their families will be eroded away. Sole Supply for a life dependent medical device is dangerous, particularly in the instances of civil emergencies, quality issues and recalls of strips or meters and the delays that occur around shipping and transport. Patients cannot administer insulin using guess work. They must have an accurate blood glucose reading in order to calculate the correct dose. Any failure of the sole supplier arrangement will cause increased doctor and hospital visits and a decline in the health and safety of the patient, which in turn will increase health costs and in some cases death. We also fear that the lack of consultation to our patient groups and to the specialist medical teams that look after our young people will inevitably end up in a decline in care and overall outcome for our young patients causing an increase in the overall health costs. (note: The New Zealand Medical Journal dated 5 March 2010, Vol 123 No1310 ‘No meter offers definite advantages over other meters in all clinical situations, rather meters should be chosen because they fit the needs of individual patients and because the provider is able to offer appropriate educational and quality assurance backup to the meter user.’) We ask that you reconsider this proposal and take time to consult fully with both patient groups and specialist medical teams to ensure the safety of patients. Appendix 1:
SAFETY ISSUES and GENERAL CONCERNS created by the
proposed withdraw of meters from the Pharmac Schedule
Please note: this information has been prepared by Karen Foster and is a volunteer laypersons interpretation of the information that we have had to assemble within an extremely short timeframe with no notice. SAFETY ISSUES
1. We note that the proposed meter has a reduced temperature band, meaning that it will not work when it is in temperatures below 10C or above 40C. Very dangerous hypoglycemic episodes are very often in the middle of the night. Many New Zealand homes record temperatures below 10C overnight. Currently the meters we use operate at 6C and above and you are able to warm them up within 5 mins. The manual for the CareSensN on page 40 talks of Er3 and suggests that if the temperature was below the operating range you need to ‘Move to an area where the temperature is within the operating range (10-40C) repeat the test after 30 minutes’. If you are on a train, bus, walking to school or on the move in any other cool environment it may not be possible to move to a warmer area. Our young people could suffer brain injury if they are very low and wait 30 minutes to respond. (note. The New Zealand Medical Journal 5 March 2010, Vol 123 No1310 states ‘Historically, low winter temperatures and cold houses made it difficult for patients to obtain accurate results. A temperature sensor is now present either in the meter or in the strips. This allows correction of the glucose value for ambient temperature across a wide temperature range. Inadvertent patient use of time expired meter test strips, which often contain ‘spoiled’ analytical reagents, was a common source of error with the older systems. This error has been minimised but not eliminated in some meter and strip systems. One example of how this is achieve, is by determining the expiry date of the strip batch from the calibration chip and pre-setting the meter software to ‘disallow’ strip use after the batch’s expiry date.) 2. Many schools have a sharps policy that does not allow un-enclosed lancet devices to be easily accessed by students. For this reason many of our patients choose to have the lancet devices that are available which are fully enclosed. As you are aware students at schools must have their medical kits with them at all times in order to keep themselves safe. It looks like CareSens will not provide a fully enclosed lancet device with their meters? 3. We understand the vials of CareSens strips will fail to work or give a faulty reading if they have been open for more than 6 months. The manual on page 9 suggests that you write the date on which you open the vial, on the side of the vial, then recheck regularly to ensure that you replace the vial before the expiry date. The problem with this is that the spare meters you have for emergencies (in the school office and in the car etc.) are not necessarily used regularly. The fact that these strips will need to be thrown away regularly and replaced is not the main issue. It is the safety problem that you could be in an emergency and you think you have strips and you don’t. So in fact you would have to keep multiple strip vials as spares and backup spares in case of expiry date problems. Children are not reliable in so far as writing accurate dates on vials especially in the rushed school environment. If an out of date strip gives a faulty reading, the wrong dose of insulin could be administered resulting in expensive hospitalisation costs. 4. We are surprised that you do not get warning of an expired strip when the strip is entered. For children they will have to do the blood test and then be told that there is an error. They will then have to do another blood test to get a reading once a new vial is located. For very young children it is not uncommon for parents to have to chase their children around the room to catch them to do a blood test, the thought that you could do a test and then be told it is a faulty strip and then to have to perform another test is unthinkable for most parents. The stress that this will cause is immense and the time delay in getting an accurate reading will be unsatisfactory. 5. It takes time for families to ensure that the instructions and safety precautions are in place for all of the people in the network surrounding a child with diabetes. If for any reason there is a failure to update the instructions and safety precautions when a meter changes, a child’s life could be at risk. 6. What about little 5 year olds who have just mastered their meters and will have to change half way through their first year of school? It can take 3 – 6 months to train a 4 year old to do their own tests. To have to retrain this group of parents will not only be excessively time consuming but it will mean that parents or other caregivers may be required to attend school with these children until they master the new procedures. 7. Families will have to pay for Optium meters to be able to test ketones and will no longer have blood testing strips funded so will have to carry two meters with them. With access to a Blood Testing Meter that allows you to test for Ketones, patients are able to monitor their ketone levels from home, thus avoiding hospitalisation. One night accommodation within a hospital environment would cost in excess of $1000, this would well outweigh the cost of the test strips that supply these meters. Children and young people with diabetes are more prone to illness than adults and they can quickly become very ill with ketones if they are not monitored and managed correctly. (Note: testing ketones with a urine stick is not real time and can often result in unnecessary hospitalisation due to the time delay of results) (Note: The New Zealand Medical Journal 5 March 2010, Vol 123 No1310 states ‘One meter system, the Optium Xceed can be dual calibrated to measure both glucose and also capillary ketones (beta Hydroxybutyrate), allowing patents to treat mild ketoacidosis at home.) 8. Families will no longer have support for Roche Combo or Medtronic pumps if these 9. Any increased opportunities for the meters to fail to perform will directly increase the inability of patients to self-manage their life threatening episodes. We note that 2 batteries are required to perform 1000 tests where one battery performed 2000 tests currently. So a 1:2000 ratio becomes a 1:500. The increased incidence of battery outages will increase risks to patients in that they may not be able to perform a test to cope with a hypoglycaemic episode if they are out of battery. 10. How do the battery warnings compare to the meters on the market? We have been unable to purchase a meter to check this. However, because multiple people care for children with diabetes, the low battery warning will need to give sufficient warning as not all people who care for the child will have access to batteries. This means that the meter has to last till it returns home at the end of the day for the parents to change the batteries. It needs to be evident immediately that the battery is low. Our current meters keep a low battery signal on them until it is rectified, is this the same with this meter? We note that the CareSens N has passed the evaluation process performed by the Christchurch Diabetes Service. However, we understand this test was under controlled conditions by trained technicians not a study in the real world setting and most certainly not with a group of patients in the age range that DYNZ represent. TRAINING AND EDUCATION

1. DYNZ will struggle to exist and run important activities such as family conferences, as we receive significant funding and support from pharmaceutical companies - many of whom we believe will withdraw from the NZ market as a result of this decision. And with the sole supplier arrangement, there will be less 'pressure' on the new company to fund and support to the extent that the previous multiple-company environment generated. 2. Further to this, DYNZ will struggle to ensure that all newly diagnosed patients and their families receive a starter pack (containing guides and resources) as these are currently funded by two pharmaceutical companies: Roche and Medica 3. Who will train the medical staff on the new software? 4. All families will have to get another blood testing meter and be trained how to use it, the DHB's will not pay for nurses time to do this and nurses are too busy to be seeing all families, schools, caregivers to do this. 5. Teachers have already had their annual training this year and will have to be taken out of 6. We believe that the level of training and support that families receive from pharmaceutical companies (which is much more than just specific information and assistance relating to their products) will be significantly less in sole supplier arrangement, increasing the burden on our volunteers and the health system. 1. Changing Meters will cause families extra stress. It will not be an ‘unsettling period of adjustment’. It will be a ‘frightening loss of safety precautions that are currently provided by the meters in use at present’. 2. All families, the patient themselves, the babysitters, the grandparents the after-school activities coaches and carers will all have to be re-trained 3. DYNZ will no longer have funding for the parents manuals and school flip charts given to 4. Families research and trial many different lancing devices to ensure that their children suffer the minimal amount of pain when blood testing up to 10 times a day. It is important for the Psychological well-being of the families that pain suffered by their children is minimised where possible. 5. Research studies have shown that it is very important when you are testing blood that you do so on the sides of the fingers, not the sensitive pads of the fingers. Damage to fingers can occur if you use lancet devices that are too fierce for delicate little fingers. Given the fact that a child endures 3650 finger blood tests per annum and that they need to use their fingers for their lifetime we do not believe that it is appropriate to economise on these devices or to remove consumer choice with this device. 6. Good health outcomes occur where families feel well supported in caring for their children with chronic illness. In turn children grow up confident and diligent in taking care of themselves. The result of this positive approach is that in taking care of themselves they in fact save the Ministry of Health unnecessary costs. EXTRA COSTS TRANSFERRED TO FAMILIES

1. Who will pay for the new download software? 2. The instruction sheets in all schools will have to be updated laminated again and placed 3. What about all the spare meters that Granny has, school has, the car has etc., who will pay 4. There will be no choice for families in blood testing meters or pumps. So if a device doesn’t suit your needs you will have to self-fund. 5. We note that patients will now have to cover the cost of the batteries themselves, where the Pharmaceutical companies provide these at present. LOSS OF TOOLS TO MANAGE DIABETES

1. What about the backlight features for families who test their little ones at night 2. What about alarm/reminder features to help people who need it 3. What about the download features so that you can analyse your records to speak to 4. Will the new software give the exact same information that we currently rely on? The quality of the reporting from the Meters to the patient and medical specialists allows for accurate adjustments to be made to the medical regime. These adjustments have a direct impact on the HBA1C and long term health of the patient. Any loss of reporting ability will result in increased cost of long term health. 5. We understand that the software does not allow the Merge function. Because most families run more than one meter at any one time they need to be able to merge the individual meter data in order to calculate adjustments to their medication 6. We note the new meter software does not appear to be compatible with Mac applications. Most young people are encouraged for school to have Mac devices and would therefore be unable to run their reports to analyse their adjustments. 7. We note that Children and Young people with Type 2 diabetes and on Metformin do not appear to qualify for a funded meter. Without a funded meter they are unable to monitor their condition. Therefore they will not be able to engage in the diabetes care for themselves that is essential in order for them to try to minimise the impact of their condition on the long term health outcome. UNDUE HARDSHIP FOR PATIENTS WHO INVESTED IN GOOD FAITH IN AN ACCU-CHEK
COMBO PUMPING SYSTEM
1. Families will not be able to use their Accu-Chek Combo Roche pumps as they will have no Accu-check strips funded. Families have purchased these pumps personally in good faith and made investment decisions based on the fact that the strips are funded. The pump will not work with other branded strips. So you either now have to fund the strips yourselves or change pumps. So this group of patients have not been provided strips under the meter proposal. The strips proposed do not meet the medical needs of this group of patients. 2. Is it likely that the current providers of devices may withdraw from the NZ market completely? If so, where will the support for products already in the marketplace be supplies from? SUSTAINABILITY AND WASTE ISSUES
1. We are concerned at the carbon footprint/sustainability precedence that this is setting. Most families will have at least 3 meters in use at any one time. One at the school office, one in the car and one in the daily medical kit. All of these current meters will no longer have funded strips and will therefore become redundant. This seems a great waste, especially given the fact that many of these meters have substantial life left in them and in many cases they are a superior model to the one you are intending to fund. Our question would be, in 3 year’s time when the sole supply agreement comes up for renewal/review, it is possible that the proposed funded meter will then become redundant and another more economic strip choice made. With another lot of training and waste….?? 2. We note that the CareSens N is listed as having a 5 year warranty and many of the current meters have a lifetime warranty. We would ask whether this difference has been factored into the cost saving calculations. 3. Small children do sometimes knock strip vials over and sometimes are inclined to play with the vial. For those particularly inquisitive types the Optium strips that are sealed are more suitable and economical. Each strip is individually wrapped so that they are perfectly fine to be placed back into the container for future use without compromising the accuracy of future testing

Source: http://www.diabetesyouth.org.nz/files/PHARMAC-Submission-DYNZ-March2012.pdf?phpMyAdmin=5dcc513c517at148ea649