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Microsoft word - 120314 pharmac submission

Natalie Davis Therapeutic Group Manager PHARMAC PO Box 10-254 WELLINGTON 6143 Dear Ms Davis, Proposal to move to a sole supplier for Blood Glucose Testing and Pumps Diabetes NZ Auckland is a NFP Society supporting more than 60,000 people, of all ages, with diabetes in the Auckland region. Whether it is Type 1, Type 2 or Pre-diabetes - the information, education and support people need in between their contacts with the formal health service are all vital in the every-day management of this condition. Blood Glucose testing meters are a lifeline for people with diabetes. They are the key tool that keeps them alive, out of hospital (thereby saving the Government millions of dollars every year) and enables them to live productive lives. People who are currently managing with a ‘diet-and-exercise’ regime still need to test (between their GP’s HbA1c tests) as a way of learning what impacts their blood glucose levels and how self-management can best be constructed. We support over 800 school-age children, mainly Type 1, in the Auckland region. These children are totally dependent on their families, their schools and sports clubs to be fully conversant with Type 1 diabetes and its management. At the other end of life, many of our members are elderly and rely heavily on family members, caregivers and rest home staff to assist them in dealing with their diabetes alongside a myriad of other conditions, all requiring a careful balancing act. All these support people also need to have a thorough knowledge of how to use a blood glucose meter. In between, there are the thousands of people living with all the variations of diabetes and the differing demands of an individual’s work, lifestyle and culture. In our opinion, a single supplier policy is dangerous and will not serve. Not only does it increase risk but also it destroys access to the device that best suits each individual’s personal management of diabetes. In addition, Pharmac’s preferred brand is relatively old technology. Many exceptions will need to be made to accommodate those with particular medical requirements. Attached are the details of our feedback on behalf of the users of meters that we represent. We request that you now reconsider this Proposal and consult fully with patient groups to ensure the best outcomes for people with diabetes in New Zealand. We recommend an alternative strategy of maintaining, at minimum, the two major existing suppliers. SUBMISSION TO PHARMAC MARCH 2012 Background: Diabetes is seen as a Government health priority with three characteristics: a) It is growing very rapidly b) It is not presently well-managed at any level (primary care, secondary care, ancillary The major disruption to diabetes management that will occur on a mass-change to another meter will prove very detrimental to improving health outcomes. We see many examples where “small upsets” in the system can have dramatic consequences. For instance, it is hard enough encouraging and supporting people to test adequately at present, without having the burden of technology change being imposed just as people start to gain self-confidence and trust in testing. It will drive people to less testing with consequent greater use of Emergency Departments. Comment: Diabetes NZ Auckland fully supports the search by Pharmac for economies in the pharmaceutical schedule. This is an important function in the management of our health spend and there have been some notable savings effected over many years. We appreciate the consultation process. However, we do note some particular anomalies in that process which need to be reviewed: Whilst you have used the PTAC Committee as an advisory group, there does seem to be a distinct absence of consumer representatives in that committee. It would have been an advantage to consult with user groups at an earlier stage. We observe that there was no field testing of the proposed glucose meters amongst users prior to the issue of your proposal. Testing by medical experts has its place but, of course, the meters are largely in home-use amongst the community of patients so ‘field’ testing with a group of patients would have provided a valuable insight on how the proposed meters perform in actual conditions. We observe that the transition period you are proposing coincides with the busiest part of the year for the medical system – winter – when primary care and pharmacists are running into peak demand. Health & Disability Commission – Patients’ Rights We believe that the current Pharmac Proposal breaches Item 4 – Proper Standards – which states “You have the right …. to receive services that reflect your needs.” United Nations General Assembly Resolution on the Prevention and Control of Non-communicable Diseases – September 2011 New Zealand was one of the signatories who adopted the Political Declaration of this Assembly. We believe that the current Pharmac Proposal breaches this Declaration in clauses: Item 45 (c) – According to national priorities … increase and prioritize budgetary allocations for addressing non-communicable diseases …. and treatment of non-communicable disease and the related care and support …. Submission on the Pharmac Proposal to move to a sole supplier for Meters & Pumps March 2012 Item 45 (m) - …. ensure the scaling-up of effective, evidence-based and cost-effective interventions that demonstrate the potential to treat individuals with non-communicable diseases, protect those at risk of developing them and reduce risk across populations; Single supplier Monopoly Risk. If the funded meters fail in any way or prove unsuitable in the NZ conditions, there appears to be no ‘Plan B’. Once the other meter companies have wound down or gone off-shore, New Zealand will be totally reliant on the performance (or otherwise) of a single supplier. Patients cannot administer insulin using guesswork; neither can they deal correctly with Hypo or Hyper situations without glucose readings. Sole supply for a life dependent medical device is dangerous, particularly in the instance of quality issues, civil emergences and recall of strips or meters and the delays that occur around shipping and transport. (Evidence: cf Roche meter-swap 3-4 years ago.) Further, we note that no New Zealand pilot of the proposed meter with users has yet been conducted. This should be a pre-requisite. Customer support: The level of support required, not only by users but also by GPs, Practice Nurses, Pharmacies, Clinics, Schools and Rest Homes, is likely to be difficult for a sole supplier to manage at start-up and in our opinion will be significantly higher than Pharmac appears to envisage. Not only must users be trained in the proper use of the new meters but also associated family members (i.e. separated/divorced parents, grandparents and caregivers who will all need separate training). In addition to this are the various staff and supporters of diabetes camps and other events that could not be held without the safe support of children temporarily in our care. Whilst it is stated that PHARMAC will work with Health Care Professionals and provide training there are no details of how this will be managed and implemented. How will it be rolled out to the other agencies mentioned above and what costs have been allowed to fund this? Pharmacy Involvement in upskilling patients on use of new meters: We are advised that for the 2,500 pharmacists in community practices in New Zealand to devote the necessary training time to the 120,000+ customers involved in this swap-out, would take an average of 16 hours per pharmacist. Of course, the burden is not spread evenly across the country so many pharmacists in high-risk areas (i.e. South Auckland) will have to devote many times this figure. Learning typically is not a one-lesson delivery. It is progressive; many return visits of customers with additional questions or who have poorly understood their initial instruction will be required. Language will be a major issue in Auckland. Submission on the Pharmac Proposal to move to a sole supplier for Meters & Pumps March 2012 Has Pharmac considered the practicalities of the exercise they are asking pharmacists to perform and what recompense will be required? If training isn’t completed satisfactorily, the burden will either transfer to Diabetes Societies, like Diabetes Auckland, with no indication of any funding allowance for this or will fall back onto Government through patients who have stopped testing, thereby increasing risk of complications through uncontrolled diabetes with a subsequent increased cost to the health system. One brand of meter does not suit everyone. As mentioned in our covering letter, there are many variables in the diabetes condition and within each of the major types that need to be taken into consideration (e.g. Management of Type 1 in children, in adults or in the elderly each have differing protocols). Much the same applies for Type 2 - a person with multiple conditions may be on treatments that interfere with the method of blood glucose readings in some brands. (e.g. people receiving oxygen can’t use a meter that gives a glucose oxidase reading). Also, people receiving IVIG treatment (IntragramP) can only use meters that are not affected by this treatment. Please advise us whether there has been any consideration given to people who fall within this category, as wrong or inaccurate readings will be life-threatening? 5a) Use in Pregnancy: The CareSens Manual states that this meter “should not be used for testing newborns or pregnant women”. Has Pharmac made provision for an appropriate blood glucose testing meter (other than the CareSens range) for pregnant women with either type 1 or gestational diabetes? 5b) Use by Ambulance and other emergency personnel: The CareSens Manual states that the meter may give inaccurate readings if used on patients experiencing a hyperglycemic or hyperosmolar state, with or without ketosis, in shock (severe hypoglycemia?) or critically ill.” Has Pharmac made provision for an appropriate blood glucose testing meter (other than the CareSens range) for the use of Ambulance or other emergency personnel? See also para 6 below: Technical Capabilities of Proposed Meters: 6a) International Standards: Do the intended meters comply with the International Standard ISO 15197? 6b) Temperature range: Not only is the CareSens safe temperature range narrower than others but also it takes significantly longer for it to come back into the safe operating range. This will be life-threatening in an emergency or hypo situation. The CareSens manual states on page 46:” … if the temperature is below the operating range you need to move to an area where the temperature is within the operating range and repeat the test after 30 minutes.” Submission on the Pharmac Proposal to move to a sole supplier for Meters & Pumps March 2012 People in the middle of a hypo whilst away from warm shelter (working in fields, walking to school or playing sport) could suffer brain injury if they are very low and have to wait 30 minutes to use their meter. This is unacceptable. 6c) Expired strips: The proposed meters continues to work when the strips are expired. Readings taken with expired strips (particularly those stored in pots that have the potential of moisture contamination each time the pot is opened) must be regarded as ‘unreliable’ and it would be dangerous for people calculating an insulin dose or taking treatment for a hypo to rely on them. Again, this renders the proposed technology unsafe. 6d) Exposed lancets: Is Pharmac aware that schools general forbid the use of exposed lancets in finger-pricking devices? The proposed lancing device has the capacity for exposed needles (by merely unscrewing the top) and therefore may be unacceptable for school use. (Compare the Roche Multiclix device – the sharps cannot be accessed.) 6e) No back-light or port-light is an issue for people who need to test during the night (i.e. a parent testing a child without waking it) or in any poorly lit area (e.g. Cinema). 6f) Ketone Testing. The Proposal states that “Optium ketone test strips will continue to be funded for existing patients requiring blood ketone monitoring.” There is no mention in the Proposal as to how new patients coming into the system will test for ketones in future. (Urine testing is less accurate as it provides only historical information not real-time results. This is old technology.) De-listing Optium B.G. strips will mean that many people (particularly parents of young children and babies for whom this is the only method of assessing their child’s condition) will need to carry multiple meters in each testing kit (School, Home, Sports bag etc). 6g) Battery life. CareSens N takes 2 lithium batteries yet, at 1,000 tests, gives only half the readings of other meters. Batteries are not provided free of charge as has been the case with some other companies, occasioning additional costs to patients (at $4.65+ per battery this is a big imposition for people on a benefit.) 6h) Software: CareSense currently does not offer download facilities to DiaSend, a facility of Starship whereby children’s data from the meter and pump can be downloaded and the hospital can analyse it to help correct any problems that may be encountered. (thereby having the potential to cost the Government millions of dollars every year in additional/unnecessary hospital admissions – currently approximately $1,000 per day per patient). No indication of the cost of software cables to download results or whether the reporting is in a form required by the GP or can be used, for example, on a Mac computer. (Note this will be more essential with the new meter as it only have a 250 memory.) Submission on the Pharmac Proposal to move to a sole supplier for Meters & Pumps March 2012 6i) Latest Technology: Dr Moodie stated that the CareSens N meter has the latest technology but doesn’t point out what this is. The CareSens N appears to have less features than other meters on the market. (Less averages, less memory, shorter battery life etc as stated above) 6j) CareSens Pop: This meter has severe limitations and we are at a loss to know why Pharmac proposes to continue funding it. With no date/time function, only 10-reading memory, extremely small test strips, its use by people with a life-threating illness is unsafe. 6k) Manual Deletion of results/memory: The ability to manually delete a result is of great concern to parents who fear their child will remove any results they don’t want seen. This could severely affect any calculation of treatment after school or before bedtime, which could have fatal consequences. 6l) Improvements: The Proposal appears to lock New Zealand into an existing and somewhat historic technology and makes no indication of whether Pharmac will encourage or fund that single supplier to bring out any improved technology before 2015 since the natural incentive of competition has been removed. We caution that, in excluding from Pharmac funding the two companies with the majority share of the market at present, that these two major companies may find re-entry costs in 2015 prohibitive, thus permanently depriving New Zealanders of access to future technology. Meter technology is changing fast, especially towards integration with Pumps and CGMs. Will New Zealanders’ care remain substandard when compared with Australia or the OECD? Non-subsidised users: “The proposal would require patients eligible for subsidised treatment to switch their current brand.” It is unclear on whether meters will be exchanged for people who do not qualify for a subsidised meter (metformin or diet/exercise). These people have purchased a meter themselves in an effort to maintain their health (and save the formal health system Emergency Department costs). The Proposal is also unclear on multiple meter exchanges for patients who have more than one meter, as mentioned in point (6d) above, to ensure their own health is maintained Disposal of de-listed meters. Should this proposal go ahead, there will be several thousand blood-contaminated meters that will require safe disposal. Nowhere in the Proposal is the disposal process discussed. Has Pharmac considered this and are the associated costs of disposal of medical waste been included? Submission on the Pharmac Proposal to move to a sole supplier for Meters & Pumps March 2012 SUBMISSION: INSULIN PUMPS We welcome the fact that Pharmac is moving to include insulin pumps and consumables on to the subsidised products list. Insulin Pumps give users greater control of their diabetes, helping them avoid costly hospital stays. Technology is rapidly moving towards Pumps that rely on or work in tandem with a particular meter. Some are already in use in New Zealand, mostly purchased at the patient’s own expense. We see this as a growth area and a path to future improved diabetes control. If the meters that work in ‘tandem’ with a pump are to be delisted, then the cost of purchasing test strips for people who are bound to use them with their particular pump needs to be carried by the State. Additionally we have concerns about the future availability of strips for these meters should the suppliers leave New Zealand. This also raises the question of repairs and maintenance of the various insulin pumps that patients have invested in to self-manage their health, the suppliers of which may now close their New Zealand operations. As stated above regarding meters, one pump device will not suit all the varying needs of patients and, although many users have funded the pump and consumables themselves, to then not be able to make full use of it because the meter and strips are unavailable is surely a backward move in diabetes management. There are inherent dangers in moving patients settled on a particular pump regime to one that may not fully suit their health requirements. Pharmac needs to encourage self-management by allowing continuance of supplies to those who have settled into a system that serves their needs. Many of the same comments shown in the Blood Glucose meters submission above apply to this proposal, i.e paragraphs 1 through 4 and the introductory paragraph of 5. OTHER CONCERNS FOR DIABETES SUPPORT ORGANISATIONS ACROSS THE COUNTRY: Diabetes Support Organisations across New Zealand are not funded by government. They rely solely on philanthropy, their own endeavours and the support of the diabetes supply industry to fund the services they provide. For Diabetes NZ Auckland, we have only been able to deliver professional services and keep membership fees at a low $20p.a. (affordable to families and those on a benefit) because of this support. Although not strictly within Pharmac’s mandate, the following points need to be taken into consideration, as they will surely severely erode any proposed savings as greater pressure is placed on Government to fund: a) Camps for children and families to learn how to live well with diabetes are held throughout New Zealand. Diabetes supply companies support these through donated product and experienced staff to help in the daily running of camps. This support will become unavailable if major suppliers are eliminated from the New Zealand scene. Submission on the Pharmac Proposal to move to a sole supplier for Meters & Pumps March 2012 Health Professional Conferences – Pharmaceutical companies help finance conferences, keeping health professionals up-to-date and skilled in diabetes management. Their support will diminish. c) Fundraising events – Diabetes Industry companies generously support our fundraising efforts, at golf events, fun runs, dinners etc. No single supplier will be able (or could be expected) to support us to the extent that, collectively, the companies we will lose have done. Less philanthropy equals less help to people with diabetes. We will be forced to diminish our levels of service to people with diabetes. d) Industry Support through advertising in magazines that keep members, GPs and Nurses up-to-date with current diabetes-care management and news. Again, no single supplier will be able (or could be expected) to support us to the extent that, collectively, the companies we will lose have done, so the viability of these communications will be at risk. People with diabetes will not receive such expansive coverage. All of the above four points have the potential to severely hamper the ability of Diabetes Support Organisation across the country to fulfil their mandate – to improve the lives of people with diabetes and to work towards a future without diabetes. RECOMMENDATION: Many of the issues raised can be overcome by broadening the proposal to include multiple suppliers. This provides the ability to meet differing needs. SUMMARY: In New Zealand, uncontrolled diabetes contributes the vast proportion of heart attacks, strokes, kidney failure, adult blindness and limb amputations to health costs – a burden set to contribute more than a billion dollars a year to the taxpayer. The present Pharmac proposal will have a dramatic, deleterious effect on the diabetes sector by: Deterring testing – many will fail to adapt to re-training At a time when diabetes is the largest pandemic faced by this country and the world, such steps are inappropriate. It surely makes economic sense to put more effort and resources into keeping people from developing diabetes complications by making available tools in use at present rather than incurring the costs of the risks being undertaken which will very rapidly swallow up the supposed $10m savings each year. We recommend the proposal be withdrawn and negotiation with multiple suppliers be completed, allowing patients’ needs to be met reasonably. UN Resolution 2011 Submission on the Pharmac Proposal to move to a sole supplier for Meters & Pumps March 2012



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