2. Which functions do you consider are optional (i.e. would be nice to have but are not essential)?

Transcription

1 1 April 2015 Diabetes Feedback PHARMAC PO Box Wellington 6143 Sent via to: To Whom It May Concern RE: FUTURE FUNDING APPROACH FOR BLOOD GLUCOSE METERS AND TEST STRIPS Thank you for the opportunity to provide feedback on the above consultation. The Pharmacy Guild of New Zealand (Inc.) (the Guild) is a national membership organisation representing the majority of community pharmacy owners. We provide leadership on all issues affecting the sector and advocate for the business and professional interests of community pharmacy. Our feedback on this consultation focuses on Guild members concerns around general economic, funding and supply issues. Guild submissions should not be taken as any endorsement of, or any attempt to comment on, issues of safety, efficacy or individual patient utility. We will address each of the specific questions below. 1. Which functions must a blood glucose meter provide/perform? It is absolutely vital that consumers are involved throughout the process of assessing meter usability. There will be some variability in what is important to different age groups, as younger users are more likely to be comfortable with technology and expect more of their meters and older users may place higher value on an easy to read screen. Pharmacists often come across patients that stockpile test strips or keep a spare packet or two to one side for emergencies ; therefore they are not always using up their oldest strips first. This means that there is potential for patients to use expired strips. It is important that a meter is able to recognise expired strips and not perform the test. 2. Which functions do you consider are optional (i.e. would be nice to have but are not essential)?

2 This is the sort of information that only consumers will be able to answer. Again this is likely to vary depending on the age of the consumer, what medications they use and how stable their diabetic control is. 3. What do you consider to be the pros and cons of each of the three approaches? outlined above? Health literacy is an issue in New Zealand and the average reading age is only about eight years old. In December 2011, the Ministry of Education s Briefing to the Incoming Minister about reading abilities stated that the gap between our high performing and low performing students remains one of the widest in the Organization of Economic Cooperation and Development (OECD).These low performing students are likely to be Māori or Pasifika and/or from low socio-economic communities. This is particularly relevant as Maori and Pasifika people have higher rates of diabetes. This needs to be taken into account when developing any training program to use new meters. Our opinions on the different approaches for usability testing are discussed below: a) Practical people may be able to work out how to use a meter themselves without needing to refer to written instructions, so this approach could hide health literacy issues. Those with poor health literacy may not be able to use other functions even if they performed well at the one or two tasks set in this situation. This approach may indicate how understandable the quick guides are. b) If there is no initial instruction, patients could end up using the meter incorrectly for the entire time of the test period. This could lead to safety issues if they aren t using it correctly unless they continue to use their usual meter during this testing phase. A time period like the suggested three to four weeks will allow sufficient time for any problems to surface. c) The usability test still needs to assess the long-term usability to iron out any unexpected difficulties. Approach (c) would illustrate what is likely to be the outcome of a more in-depth consultation with the patient in a health practitioner setting, e.g. similar to what would happen in a community pharmacy. 4. Do you think that usability testing should use one of these approaches or a combination of these three approaches? There are good elements to all three approaches; however using one method exclusively will not capture all the likely patient groups affected by a change. The Allen & Clark 1 evaluation highlighted how ethnic groups respond differently to different methods of training. Maori and Pacific patients preferred face-to-face interactions. Chinese patients ignored any instructions written in English. Any of the methods need to ensure they consider cultural issues and that the usability testing is culturally appropriate. 1 Allen & Clark, Evaluation of the implementation of a decision to change the funding and supply of blood glucose meters and test strips, 1 September 2014.

3 A combination of the approaches would be helpful, i.e. a + b or b + c. It is important that an initial usability test is performed, as well as a longer-term assessment so that patients are given time to allow any problems they experience when using the meter to surface. Whatever approach is taken, it is important that the patient groups that are likely to struggle with the changeover are represented in the testing. 5. Are there any other methods of usability testing you think would be better? It will be helpful to explore usability testing undertaken by the health professionals that would be expected to be demonstrating the use of meters to consumers e.g. pharmacists and practice nurses, in addition to consumer usability testing. 6. What criteria should be used when assessing the usability of a blood glucose meter? How intuitive it is to use and this judgement must be assessed by consumers as opposed to a recommendation made by the Diabetes Subcommittee as was the case during the CareSens brand change. Something else to consider is that it is not conducive to regular testing, and therefore better diabetic control, if the meter type is changed every three or fours years. People have sufficient change in their lives without changing something as critical as the brand of their diabetes meter without their being a real need for change. 7. What further accuracy and clinical assessment criteria should be considered, i.e. what further analytical functions should a meter and test strips have? The ability of the meters to test blood ketones should be considered as well. PHARMAC undertook clinical testing of CareSens meters however this testing was in a controlled setting only, rather than a real world setting. Clinical testing in a real world setting is crucial in order to identify the functionality and usability issues for real patients. A common complaint reported to pharmacists with respect to the CareSens brand was the meter s inability to perform in cold conditions. Meters and strips must be tested against temperature and humidity assessment indicators. 8. Have you been involved in the testing of meters and test strips or can you suggest who could conduct testing of this type? No. 9. What support (i.e. educational, information) from suppliers of meters would be desirable?

4 Patients asked pharmacists whether the new supplier would be as available as Roche had been to answer patient concerns. This illustrates how important it was for patients to be able to have direct contact with the supplier for any concerns. It is essential that health practitioners and patients have access to a toll-free supplier helpline. The supplier must provide every pharmacy with free demonstration meters so that they are able to demonstrate to the patient. Not all pharmacists were aware during the CareSens brand change that they were able to request demonstration meters. It is important that any support is culturally appropriate. With the CareSens brand change, patients raised concerns over meter accuracy and the tendency for it to produce higher readings on average than other meter brands. These concerns were often referred to pharmacists who found it difficult to answer. Pharmacist support that includes a resource that can be given to patients with a troubleshooting page explaining potential causes for error readings would be helpful. A resource that has information on how to help patients understand the reason for the brand change, potential patient objections and how to deal with these, would be extremely helpful for pharmacists and other health professionals. 10. What accessories should be provided with meters - for example a case, lancing device etc.? Case, lancet, spare batteries, and an initial supply of test strips. If calibration is required, the calibration solution must be provided to patients so they are able to perform this themselves. During the CareSens change, pharmacists spent considerable time undertaking calibration of meters. The calibration took approximately 15 minutes per patient and then it often led to other questions and meant pharmacists spending up to half an hour per patient who wanted their machine calibrated. 11. Should different types of meters and test strips be funded for people who are taking different medications (i.e. a different meter for those administering insulin versus those on oral diabetic medications) or who have differencing clinical circumstances (i.e. are visually impaired or who test for blood glucose and blood ketones)? While it is important to recognise that one size does not fit all, it would be helpful if there was one meter funded that was appropriate for all users. Different versions or models of the same meter could accommodate differences in users such as those with poor eyesight, but all versions would need to use the same strips and have the same usage instructions. It would not be helpful for patients who have started on oral diabetic medications to have to change to a different type of meter should they progress to insulin. It was clear from the change to the CareSens brand, how reluctant some patients were to the

5 change. If people have uncontrolled diabetes, they can die. Therefore some of this reluctance to change stems from their reliance on the meter that they are familiar with. Most important for patients with a lifelong condition such as diabetes is stability. It is unacceptable to change a brand of meter every three years for these patients As stated above, a meter that could test for blood ketones as well as blood glucose could be of benefit to many patients. 12. What software and data capabilities of funded meters are both practical and desirable? Results that are easy to download to a patient s computer or uploaded to a shared care platform would be of benefit. Results that can be transferred to phone apps may be helpful. Reminder functions for adherence. Text alert capability. 13. Are there any other comments you wish to make related to this proposed approach? Patients expressed their concern to pharmacists about who would service the meters and pay for that service, as well as who would pay for battery changes. As you will be aware, prior to the switch to CareSens, all these functions were provided for free from Roche. The brand switch fee paid to pharmacy was insufficient for implementing such a major change. Pharmacists spent anywhere from 5 minutes to 45 minutes per patient explaining the change to CareSens brand and how to use the new meter. Many pharmacists reported spending time with a patient on multiple occasions explaining the brand change. Last time a brand switch fee was listed for the meter and another for the strips. This amounts to $10.60 and is sufficient to purchase 5 minutes of a pharmacist s time at current average charge out rate. If PHARMAC want pharmacists to spend longer than 5 minutes with each patient they will need to consider how to reimburse this. Pharmac provided close to $44,000 of community support grants in the latter stages of the CareSens brand switch to Maori, Pasifika and consumer organisations to engage with patients. There were also payments made to PHOs to recognise their efforts in the brand change. The actual savings to the Combined Pharmaceutical budget was $10.1 million in the 2013 calendar year as a result of the change. Some of this saving would have been better allocated to a sufficient brand switch fee for pharmacists to ensure that all patients received the same level of advice at their community pharmacy. Pharmacists play a key role in reassuring patients when a medicine or device is changed. Pharmacists address any patient concerns over safety and effectiveness. It can often take a significant amount of time and skill to do this. The pharmacist is the health

6 professional patients see most often and the pharmacist-patient interaction also provides an opportunity to check the patient understands diabetes and the reasons for undertaking blood glucose measurements. It is important that the contribution a pharmacist makes to the overall health of the patient is recognised. Pharmacists were eligible to prescribe and claim for one meter per patient between 1 September 2012 and 1 March 2013 for the CareSens brand change. This removed much pressure from GPs and likely contributed to the speed of uptake on the new meters. It is important that any future changes enable pharmacists to prescribe and claim in a similar way. The Allen & Clarke report stated that the single supplier arrangement requirement with Pharmaco regarding CareSens was for Pharmaco to hold four month s worth of stock. The Guild received many calls from pharmacists regarding difficulty sourcing stock by the end of September 2012, as well as the supplier running out of two of the three meters. Stock shortage puts undue stress on pharmacists and patients. Measures must be taken to ensure that there are no stock issues with any future brand change. Thank you for taking the time to read our response to your consultation. If you have any questions about our feedback, please contact our Pharmacist - Professional Services and Support, Tracey Sullivan, at t.sullivan@pgnz.org.nz or Yours sincerely, Lee Hohaia Chief Executive