Birmingham, Solihull, Sandwell and environs (BSSE) Area Prescribing Committee's formulary (APC) for blood glucose meters was published in 2015. By 2017, advances in the meters and a fall in the price of test strips had left it out of date. Increasing expenditure on blood glucose (BGTS)/ketone test strips (£3m increase in 5 years) for Birmingham and Solihull Clinical Commissioning Group (BSol CCG); and more expensive BGTS being prescribed, meant the % growth expenditure was not reducing at a rate comparable to England and other CCGs. (Appendix 1 P3-5).
With over 80 glucose meters now on the market, the challenge was to create a quantitative evaluation process to select products that meet the needs of all diabetic patients across the health economy including paediatrics, gestational diabetes and specialist populations such as those patients on insulin pumps or carbohydrate counting. Mindful that the previous review took 2 years, the new process had to be efficient.
Guided by the parliamentary report (Reference), our goals were:
Reference: Best Practice Guidance: Development of a formulary for blood glucose testing devices. All-Party Parliamentary Group on Diabetes (July 2014)
The BSSE APC's Diabetes Medicines Management Advisory Group (DMMAG) formed a sub-group to undertake this project. Led by CCG pharmacists, it had clinical representation from all local NHS sectors (doctors, secondary care diabetes specialist nurses (DSNs) (adult and paediatric), community DSNs, practice nurses, diabetes specialist pharmacists (primary and secondary care) and also collaborated with patient groups and industry. A review process was established by the subgroup of DMMAG and approved by BSSE APC and also the Solihull CCG Patient panel. (Appendix 2). A generic email was established for pharmaceutical companies and BGM DMMAG sub group members to use with cloud access and a project timeline was created. (Appendix 3)
All manufacturers were invited to participate in the review and received the evaluation criteria (Appendix 4). The resulting completed evaluation criteria forms were scored, and the shortlisted products put forward for a Diabetes UK (DUK) organised patient event. (Appendix 5). Evaluation sheets were co-designed (Appendix 6 & 7) with the subgroup of DMMAG and DUK and approved by CCG Equality and Diversity leads. Patient attendees reviewed the shortlisted products, with diabetes nurses and pharmacists available to help. Needle sample packs were distributed at the patient event to be tested at home and the questionnaire's returned to DUK. DUK compiled the patient feedback into a report, this informed the final recommendations.
The review process and final guidance was published with open access on the BSSE APC website. (Appendix 8 & 9) After publication, the DMMAG subgroup finalised the implementation plan (Appendix 10). Involvement of all the stakeholders has aided implementation of the final formulary.
To aid uptake in primary care, launch events will take place across BSSE; (Appendix 11) for an example strategy from Solihull (Appendix 12):
We will continue to hold launch events for the formularies in different areas of the BSSE APC and will invite community Pharmacists, district nurse teams as well as GP practice staff.
Patients are our main beneficiaries of this project. Feedback from the patient event highlighted service users (and clinicians) wanted more advanced features to be available in the formulary choices, such as smartphone applications and links into clinical systems, as well as simple meters. This means more patient choice and a goal of improved diabetic control. We took their feedback into consideration and achieved our goal of creating a single formulary for meters, needles and lancets that encompasses the preponderance of diabetic patients. Plus a single formulary across the BSSE area to reduce 'postcode prescribing'. An approved implementation plan meant that it was agreed that “bulk switching' of meters without patient consent is actively discouraged. The formulary also includes guidance on self-monitoring of glucose (SMBG)/ketone, clear guidance on self-monitoring with an aim to prevent inappropriate rationing of test strips.
The CCG benefits as the new formularies include high quality and cost-effective meters and needles. Birmingham and Solihull CCG spent £3.68m on glucose and £286,000 on ketone strips in 2017/18. The total has increased by £3.08m over last 5 years (Fig. 1 & 2, Appendix 1). The new formulary forecasts a combined potential saving of approximately £660,000 in 18/19 which means that the NHS budget can be used wisely and reinvested to benefit patients. We have also produced a needles formulary with a forecast saving of £289,000 per year. (Appendix 1)
All stakeholders in involved in this project have benefited, it has enhanced cross-sector multidisciplinary working, including with Diabetes UK and will enable collaboration on future projects. Including all the stakeholders meant there is a sense of ownership regarding the formulary choices and including a wide range of healthcare professionals across the BSSE APC meant that they were familiar and happy with the products and supported the implementation of the new guidance. (Appendix 14)
Our new formulary has also enabled a Birmingham hospital to pilot a system of reviewing blood glucose results remotely via smartphone applications; this will reduce gestational diabetes attendances and improve patient experience.
“A unique and patient-inclusive positive project, combining effective collaborative teamwork between patients, Diabetes UK and the CCG,” Peter Shorrick, Regional Head (Midlands), Diabetes UK
Production of a Blood Glucose (and ketone) meter, needles formulary with improved cost and time efficiencies.
The project has led to the production of a single meters formulary, appropriate for diabetes patients across the health economy with advice on 'expert meters' e.g. pump compatibility or carbohydrate counting in addition to gestational and paediatrics benefits patients and clinicians (Appendix 8). Advice on specialist meters (gestational, paediatrics, insulin pumps etc) helps clinicians.
The meters have been thoroughly evaluated by specialist clinicians and patients, representing best practice. It also includes new CCG guidance on self-monitoring of glucose (SMBG)/ketone. The Insulin Pen needles formulary, includes advice regarding pen needle lengths, disposal and counselling points. (Appendix 9)
Since all manufacturers were invited to participate in the review and received the evaluation criteria. This significantly reduced the number of products for consideration, improving efficiency. Establishing the review process denotes time efficiencies, since the quantitative evaluation criteria can be updated and used to re-evaluate products for future formulary reviews) (Appendix 4)
The 6-month timescale (compared to 2 years for the last review) for completion of the meters/lancets formulary review was achieved which saved clinician time (when involved in the DMMAG subgroup) and maintained momentum for change. It coincided with the formation of the new Birmingham and Solihull CCG, merger of the two acute trusts, and the start of the new financial year.
Collaborative / integrated approach
Key to the success of the project was a collaborative approach that included all key stakeholders. This project has enhanced cross-sector multidisciplinary working, including with Diabetes UK. The evaluation was sanctioned by DMMAG and members nominated they to be part of the sub-group. The sub-group had clinical leadership from one of the secondary care diabetes specialist nurses (Theresa Smyth, DSN) and the project overall was led by the CCG diabetes lead pharmacists. This meant responsibility for completion was shared between primary and secondary care and was multi-disciplinary in its approach. Successful collaboration between CCG, patients and clinicians created reassurance that formulary choices weren't solely cost-driven and facilitated future team-working.
The following were the key stakeholders:
Clinical staff
Primary and secondary care clinicians (doctors, nurses and pharmacists) from across BSSE created the evaluation criteria, scoring matrix, shortlist of products, provided expert advice, and made final recommendations.
The sub-group identified that there was no paediatrics representation, so the lead paediatric DSN at Birmingham Women and Children's hospital was invited to participate. This ensured the final guidance was applicable to both adults and children/young people.
Patients
The full review process was sanctioned by the CCG patient panel. Diabetes UK was also approached to act as a partner and facilitate patient evaluation. They held a patient evening event where samples of the shortlisted products were made available (Appendix 5); evaluation sheets were co-designed with the project leads (Appendix 6 & 7), these were checked and signed off by a CCG Equality and Diversity lead. Attendees at the event reviewed the shortlisted products and provided feedback via a scoring system. Diabetes nurses and pharmacists attended the event to help patients with the new machines. Diabetes UK independently compiled the patient feedback into a report. This helped to inform the final recommendations.
Pharmaceutical industry
All manufacturers were invited to participate in the review and received the evaluation criteria (Appendix 4). They had ownership over which products we should consider, and which information was pertinent.
The robust process allowed any formulary challenges to be dealt with effectively, sharing the process and scoring system with industry ensured transparency. Some companies chose not to participate; others only submitted some of the products they make. This significantly reduced the number of products for consideration. Working with industry streamlined the process and simplified training delivery.
Commissioners
The CCG diabetes pharmacists led the project, bringing together all the stakeholders, and keeping it to time(Appendix 3). They prepared the final guidance and presented it to APC for approval. They also ensured the outcomes fit in with CCG priorities to facilitate primary care implementation.
This project has enhanced cross-sector multidisciplinary working, including with Diabetes UK to promote collaboration on future projects.
Good User feedback
“A unique and patient-inclusive positive project, combining effective collaborative teamwork between patients, Diabetes UK and the CCG,” Peter Shorrick, Diabetes UK (Midlands) (Appendix 14)
Primary and secondary care clinicians were integral to the evaluation process. Our diabetes dieticians particularly liked a feature of the new meters that allows photographs of meals to be linked with blood glucose readings.
The BGM subgroup set the quantitative evaluation criteria, this was used to shortlist, support challenges from industry and minimise bias.
Presenting the formulary process to a CCG patient panel highlighted the need to ensure disabilities were considered and this led to changes being made e.g. to the evaluation form at the patient event.
We felt it was important the patient event was organised and led by DUK as an independent, respected charity representing the views of service users.
A range of meters in each category maintains patient choice; the previous formulary only included 4 meters.
Sharing good practice
Since publication, a neighbouring CCG has requested use of the review process. It has also been shared with the West Midlands Cardiovascular Network, and NHS England (West Midlands), who have asked CCGs to prioritise BGM.
