Pharmacy Aseptic Services Review Summary of Key Findings · • What is the current state and level of variation? • What are the reasons for variation (warranted and ... Secondary

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Pharmacy Aseptic Services Review Summary of Key Findings 28th March 2018

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Introduction

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Introduction

A key recommendation from Lord Carter’s report “Operational productivity and performance in English NHS acute hospitals: Unwarranted variations” is to shift the balance of activity in the pharmacy workforce from essential pharmacy infrastructure services to clinically facing roles.

Each non specialist acute trust in England then produced a Hospital Pharmacy Transformation Plan by April 2017. Many of these contained plans to consolidate aseptic services. At the same time there is growth in the volume of products that need aseptic preparation and there have been significant withdrawals from the market in the commercial sector.

Context

• Aseptic services by and for acute hospitals in England • MHRA Licensed and unlicensed (i.e. Section 10) activity • In-house NHS aseptic services and outsourced sources (both from NHS Providers and non-NHS

commercial suppliers) • Product categories: chemotherapy, parenteral nutrition, clinical trials / investigational medicinal

products, and pharmacy-led radiopharmacy (results for this available separately)

Project scope

• The aim of the review is to enable NHS Improvement to gain a comprehensive understanding of the nature and location of currently available services, which will be used to inform planning for future service provision that promotes quality and resilience plus ensures patient access to the medicines provided by these services

• Specific aspects of these services on which information was sought included: geographical location, capacity (staff and facilities), estate & equipment, management structure, staffing establishment, operational costs, service hours, range of products & services provided, and customer base

Aim

Presenter

Presentation Notes

Introduction: Building on the Carter Review and feedback from the Hospital Pharmacy Transformation Plans submitted a comprehensive understanding of the pharmacy aseptic services landscape was identified leading to the proposal of a business case which was written and approved in April 2017. NHS Improvement commissioned Deloitte through a formal tendering process to carry out this exercise with the clear objective or providing a tactical and strategic review of NHS Aseptic services in England including MHRA licensed, unlicensed, outsourced and pharmacy-led radiopharmacy services through the collection of intelligence from a data collection template and interviews.

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Approach for aseptic review We gathered evidence to map the current state and evaluate strategic choices to improve service sustainability, resilience, and future-readiness

What is

supplied?

• Product range and rationalisation

• Procurement practice

• Pricing practice

2.Products & materials

• Demand by product type & location

• Pipeline product trends e.g. ATMPs, biologics

• Policy impact e.g. R&D and clinical trials

• Unmet need

• Clinical area vs. pharmacy preparation

1. Needs & trends

What is the demand?

• Supply chain options

• Licence status, QA and audit results

• Geo coverage, supply consolidation, and contingency

• Outsourced compounding (NHS/ commercial supplier)

3. Outsourced / supply location

Who supplies and from where? How is supply managed?

• Prescribing practice & clinical planning e.g. 2-step chemo

• Stock levels, waste, and recycling

• Production management IT

6. Logistics, planning, & control

• Workforce capacity

• Staffing models

• Recruitment & training

• Succession plans & careers

• Equipment status and obsolescence

• Capital investment e.g. Facilities, automation

• Maintenance and QMS (Quality Management Systems)

4.Staff 5.Estate, equipment & automation

Demand assessment • What is the current product

demand (Chemo, PN, CIVAs, Radiopharmacy, IMP) from aseptic Facilities?

• What is the expected future demand and change to product demand?

• What is the unmet demand?

A B

Supply assessment Map current state • What is the current state and level of variation? • What are the reasons for variation (warranted and unwarranted)? • What are the pain points and challenges? Options for future state • What are the different operating models and options? • What does ‘good’ or ‘best’ look like? • What are the Requirements for success?

Impact of choices • What are the benefits i.e. cost, risk, revenue, access, and experience?

• What are the disbenefits? What is the impact or dependency on other strategic choices?

Roadmap future state • What are the elements of a business case to assess a

strategic choice? • What are the milestones to deliver it? • What are the barriers, including governance and legal

implications?

Stra

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se

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s

Presenter

Presentation Notes

The approach to this was made up of 4 main sections: What is the current demand by product types, if these were made on the ward or in an aseptic facility and what products and policies are currently in the pipeline. This would also include the current unmet needs. What is supplied from the aseptic units CIVAS/PN/Clinical trials. What is the range of products supplied? Are these rationalised at all? Who supplies and from where? Geographical coverage, are these supplies from an NHS supplier or an outsourced company? How is supply managed? This has been broken down by staff, estates and logistics Staffing –looking at the workforce, skill mix, recruitment and retention. Estates looks at the current state of the facilities and equipment – maintenance costs, any planned investments and what quality management systems exist. Logistics and planning looks at the systems used to plan the capacity of the unit, what are the determinants of these including prescribing practices and any IT systems used to manage this and stock management and waste control. These findings from the data collection template alongside interviews have allowed us not only to map the current state but has allowed us to determine a minimum dataset for the model hospital, create a series of case studies for existing units to use and a business case framework to use for future investments.

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Process for aseptic review Evidence in this review was collated from engagement with stakeholders and data collection

Data template returned by 195 Aseptic Service Facilities and Radiopharmacy facilities in 142

Trusts

Secondary research and additional data sources

97%

3%

% Facilities that returned data

Not sent data

Sent data

• NHS Benchmarking

• MHRA

• Model Hospital

• NHS Digital

• HSJ Intelligence

• EvaluatePharma

• DataMonitor

• Companies House

• MINT UK

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1 2 1

15

NHS Trusts NHS Collaborations

e.g. STP

Commercial Suppliers

1

NHS Regional

QA

NHS Professional

Networks

Other NHS e.g. NHSE/I,

Scotland

4

9

1 2

Completed interviews

Interviews by organisation type NHS Trust & Collaboration Interviews by region

Conducted 32 interviews across 43 stakeholders

London

North

Midlands & East

South

4 (21%)

3 (16%)

9 (47%)

3 (16%)

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Presenter

Presentation Notes

The evidence for this review was collated through 32 structured interviews across 43 NHS stakeholders and the breakdown by who these organisations were and which region in England can be seen in the breakdown in the first two graphs (comment majority of interviews with NHS trusts, of which majority were in the north region). A data template was designed by a number of specialists in Technical Services and was sent out to trusts for completion on the 12th of December 2017 and despite the winter pressures, Christmas, the 6-week turnaround time and approximately 4000 data points to be completed on a full return, we received an outstanding return of 97%, that is 195 trusts!!! The sample size for radiopharmacies is much smaller (<15% total radiopharmacies) and skewed towards small Section 10 facilities because only pharmacy-led radiopharmacies were in scope for this review Data sources for any secondary research was done independently using the sources available such as the MHRA and the NHS benchmarking data on aseptic services.

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Sample for data collection

Source: Aseptic Facility data collection JAN 2018

No data received within the deadline

1. Ashford And St Peter's Hospitals NHS Foundation Trust 2. Medway NHS Foundation Trust 3. Mid Cheshire Hospitals NHS Foundation Trust 4. Moorfields Eye Hospital NHS Foundation Trust 5. The Robert Jones And Agnes Hunt Orthopaedic Hospital NHS Foundation Trust 6. The Walton Centre NHS Foundation Trust 7. United Lincolnshire Hospitals NHS Trust 8. Warrington And Halton Hospitals NHS Foundation Trust

97%

76%82%

86%

Mean

Lower Quartile range

Median

93%

Staff Outsourcing + collaboration

Consumables + services

Demand + unmet need

Quality + risk

79%

Upper Quartile range 100%

90%

Facility + Equipment

79%

86%

99%

92% 89%

Preparation Time

Sampling

Product portfolio

75%

68%

90%

98%

Distribution of completion rates per worksheet (excluding non-responders)

Presenter

Presentation Notes

We received no data from 8 trusts, of which 2 did not have aseptic units and required us to use data from an existing submission. Six of the trusts had to be excluded. The graph here shows the ‘data quality’ in terms of completion of each worksheet within the data collection template. The drug level sampling worksheet is not shown here as completion for this was not tracked.

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Evidence confidence What is

supplied?

2.Products & materials 1. Needs & trends

What is the demand?



6. Logistics & ordering 4.Staff 5.Estate, equipment

& automation

Dat

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& d

ata

anal

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Demand + unmet need

Volume prescribed over time

Product portfolio

Volume made in-house under licence or S10

Chemo standardisation

PN standardisation

Charging practices

Drug level sampling

Shelf-life variation

Facility + equipment Staff Outsourcing + collaboration Product portfolio Consumables + services

Cost per item

Facilities + equipment

IT systems to manage production and ordering

Transportation ownership

Outsourcing + collaboration Product portfolio

Supply models

Level of outsourcing

Current supply networks

Intro + tracker

Future licence plans

Staff

Tenure of leaders

# QPs and QPs in training

Vacancies

Turnover

Staffing models

Task allocation variation

Staff capacity

Overtime

Capacity calculation variation

Hours of training

Opening hours variation

Facility + equipment Staff Outsourcing + collaboration Product portfolio Consumables + services Demand + unmet need

Future workforce size

Facility + equipment

Age of Facility and condition

Age of isolators/cabinets and condition

Age of AHUs and condition

Under-utilised equipment

Use of automated filling

Key: High confidence Medium confidence Indicative Not possible due to poor quality / incomplete data

Presenter

Presentation Notes

This slide outlines a deeper understanding of the quality of the data that was collected for each section. The green dots indicate high confidence in the evidence collated and the reds and greys indicate a lesser degree of confidence or none at all. Data for the cost per item was impossible to collate as more often than not this data was unavailable The level of outsourcing and staff capacity were only indicative in terms of confidence as practices for recording this data were highly variable across the board. It should be noted that the evidence confidence for all the radiopharmacy data analyses is ‘indicative’ due to the smaller sample size and skew towards small section 10 facilities.

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Current state Radiopharmacy data not included, although findings are highlighted where relevant

Presenter

Presentation Notes

The following results show the current state of aseptic services across England. The sample is not indicative of the whole of the radiopharmacy community but refers to pharmacy-led radiopharmacy (17 out of c.130 radiopharmacy of which 8 sites in the sample have MHRA Licences).

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Wha

t is

the

dem

and?

Demand for aseptically prepared products is increasing at c.5% per annum. Alongside meeting the growth of core chemotherapy and parenteral nutrition (PN), there is need to anticipate future demand for advanced therapy medicinal products (ATMPs, such as gene therapy), growth in clinical trials, and potential to address the sizeable unmet need for central intravenous additives (CIVAs) and monoclonal antibodies (MAbs)

Wha

t is

supp

lied?

Many Aseptic Services have successfully adopted dose-banded chemotherapy and enabled efficient high volume production. In contrast, PN is mostly made under Section 10* to the specific requirements of individual prescriptions and there is less awareness of the potential to standardise

Who

sup

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s an

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om w

here

?

The NHS relies upon commercial suppliers for at least a third of aseptic compounding and the commercial supplier market is concentrated and highly competitive with low single digit operating margin (c.5%). Many Licensed NHS Facilities reported that they already supply customers**. There remains an opportunity to optimise geographical coverage and maximise efficient batch production to achieve better return on investment

How

is s

uppl

y m

anag

ed?

Aseptic preparation is a labour intensive process and many Aseptic Facilities face significant problems with workforce recruitment, training, and retention. Lack of staff capacity is preventing c.60% Aseptic Facilities from offering desired services and a standard method to calculate capacity is needed to plan for national and local workforce requirements

An in-house NHS Aseptic Service is asset intensive: estate and equipment needs ongoing maintenance and periodic renewal, so high utilisation is preferable to maximise return on investment

Digital systems and collaboration with clinicians are critical to reduce waste, to control and share stock, and to optimise the timely flow of products, information, and prescriptions

Summary of key learnings about current state NHS Aseptic Facilities in England need to transform to deliver a future-ready, resilient, high quality, safe, and efficient service

Notes: *Section 10 of the Medicines Act enables a Pharmacist to supervise preparation of products against a prescription without needing a Specials Licence from the MHRA; ** external to their organisation, other NHS Trusts, as well as providers in other UK home countries and commercial suppliers Source: NHS stakeholder interviews; Aseptic Facility data collection JAN 2018; Companies House; MINT UK

Location and type of Aseptic Facilities

Presenter

Presentation Notes

A range of mapped data relating to the project has been developed and will be made available to support service planning

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What is the demand? 1. Needs and trends

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Summary of demand needs and trends

What is the demand?

Wha

t is

the

dem

and?

1. N

eeds

& tr

ends

Demand by product type & location

• The demand for aseptic medicines is increasing in all product categories: electronic prescribing of chemotherapy is growing at a constant 4.8% CAGR* and PN prescribing appears to have accelerated in the last year (from 4.7% to 8.0% growth per annum)

• Over time, products have also increased in complexity and require more time and skill to manipulate. Consequently NHS Aseptic Service workload is increasing at a faster rate

• Electronic prescribing records show that demand for Clinical trial products and antibiotics is also growing, but not as fast (c.1% CAGR)

• It is unknown what proportion of demand is appropriate (i.e. based on real clinical need)

Pipeline product trends e.g. ATMPs, biologics

• Aseptic medicines are predicted to continue to increase as a proportion of global drug spend and injectable medicine sales are growing at 7.3% CAGR

• Oncology drugs are an increasing proportion of the global research & development pipeline • Whilst few Trusts are currently involved in clinical trials of ATMPs, following national

tendering for 7 genomics sites, the demand for preparation of ATMPs may increase

Unmet need and clinical area vs. pharmacy preparation

• There are 2 strategies to address “unmet need”. Whilst most NHS stakeholders continue to follow an NPSA risk-based approach, a minority of Facilities have developed an efficiency aspect to their product portfolio assessment strategy

• NPSA risk-based strategies focus on the small volume of “red” CIVAs and MAbs (if any) and do not consider the workload impact on senior nurses of preparing many simple manipulations before drug rounds

• Volume-based and efficiency strategies aim to use stocked pre-fills (either outsourced or made in-house) to save nurses time

Policy impact e.g. R&D and clinical trials

• Government R&D policy is likely to continue to increase clinical trials and demand for IMPs** • NIHR funding has increased in every region on average 8% per annum, but the scale and

growth in funding varies per region

Demand for aseptically prepared products is increasing at c.5% per annum. Alongside meeting growth of core chemotherapy and PN there is need to anticipate future demand for ATMPs, growth in clinical trials, and potential to address the sizeable unmet need for CIVAs and MAbs

Notes: *Compound annual growth rate, ** Investigational medicinal products include drugs and placebos being tested or used as a reference in a clinical trial Source: NHS stakeholder interviews; Aseptic Facility data collection JAN 2018; Companies House; MINT UK

Presenter

Presentation Notes

The findings have shown that not only is the demand on aseptic services for all products growing (especially chemotherapy) but so is the complexity of products (with the introduction of ATMPs) requiring a greater amount of time and skill for the safe manipulation per product. With ~ 2000 immuno-oncology agents currently in development, many of the oncology drugs in the late stages of development at the end of 2017 , national tendering for 7 genomics sites and an increase in NIHR funding across England (reference NIHR, UK Clinical trials Gateway, Aseptic Facility data collection Jan 2018 for the years 2004-2014) the demand on aseptic services is predicted to continue to grow (unless manufacturers make these available as ready to use injectable-removing the need for manipulation prior to administration). Confidence in this data is rated at medium as it is unclear (due to tight period of time for data collection and lack of EPMA systems across all units) what proportion of this demand is based on ‘real clinical need’. There are 2 main strategies used to address the unmet need across all the aseptic units. Whilst most continue to follow an NPSA risk-based approach, a minority of Facilities have developed an efficiency aspect to their product portfolio assessment strategy with greatest focus on chemotherapy and PN lines.

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What is supplied? 2. Products and materials

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Summary of current state products & materials W

hat i

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2.P

rodu

cts

& m

ater

ials

Product range and rationalisation

• Excluding CIVAs, 80% of the units made in-house by the NHS are chemotherapy, 15% are PN, and 5% are Clinical Trial doses

• Irrespective of Facility licence status, 76% of chemotherapy, PN, and clinical trial units are prepared under Section 10*

• Including CIVAs, 45% of the units made in-house by the NHS are CIVAs, 44% are chemotherapy, 8% are PN, and 3% are Clinical Trials

• Irrespective of Facility licence status, 51% of these products are prepared under Section 10

• c.90% of chemo volume is dose-banded and 68% Facilities believe further standardisation is possible

• Dose-banding has been approved at Trust-level for 95% of Facilities and 90% have implemented the dose-banding CQUIN to incentivise uptake by clinicians

• On average, c.24% of the PN portfolio is scratch bags made in-house and c.41% are complete unlicensed regimens outsourced to commercial or NHS suppliers; therefore there is significant opportunity to standardise PN

• According to good practice, it may be possible to reduce the number of formulations and develop a standard list of licensed base bags for most adult patients

• Some Trusts have also developed base bags with standard additions for neonatal PN (see page 142)

• Fewer Facilities believe there is opportunity to standardise (i.e. increase the use of licensed base bags): 49% for adult PN and 36% for neonatal PN

• Shelf-life at named drug level varies significantly across Facilities • The differences may be explained by: inherent differences in drug presentation,

differences in operating procedure or licence status, or extended shelf-life gained from a stability study

Pricing practice

• 90% of Aseptic Services recover costs fully or partly through budgets agreed with their Trust; however, 22% report that their budgets are in deficit

What is supplied?

Many Aseptic Services have successfully adopted dose-banded chemotherapy and enabled efficient high volume production. In contrast, PN is mostly made under Section 10* to the requirements of individual prescriptions and there is less awareness of the potential to standardise

Notes: *Section 10 of the Medicines Act enables a Pharmacist to supervise preparation of products against a prescription without needing a Specials Licence from the MHRA Source: NHS stakeholder interviews; Aseptic Facility data collection JAN 2018; Companies House; MINT UK

Presenter

Presentation Notes

The portfolio of products made in an aseptic facility varies considerably. Where CIVAs is excluded, understandably chemotherapy (estimated spend of £1.5bn on routine commissioning of chemotherapy, with drug costs being 80% of this) is the main product made in aseptic units, where 90% of this volume is standardised, largely driven by NHSE’s CQUIN incentivisation driving uptake by trusts, however there remains more capability to standardise chemotherapy further. PN remains a small percentage of the total product portfolio made in aseptic facilities, there remains a large number of bespoke/scratch bag formulations produced especially in the paediatric and neonatal populations, where 41% of these are complete unlicensed products. These require complex calculations and manipulations increasing the potential for error at each stage of the production and checking process. One model emerging to help alleviate this production and risk burden is that of UCL. Alongside their network, UCL are planning to implement rationalised PN products for babies born before 32 weeks in April 2018, accounting for c.70% of the Neonatal PN portfolio. Their intention is to have 2 products in the range only, both will be extended shelf-life high-protein feeds with trace elements included in the bags, which will be outsourced in bulk. Where needed, feeds will be tailored to the individual patient by giving syringes of lipid emulsions and vitamins via a side arm injection. This model wold endeavour to free up 2-3 hours per day in the aseptic unit. One of the main findings of this section was the variability in how these products are manufactured and under which banner? Is it section 10 or under a manufacturers license? Irrespective of the status, 51% of all products are prepared under section 10, having a knock on effect on the shelf-life of products. Those that are prepared under a specials manufacturing licence are also affected by shelf-life variability, a result of the lack of centrally NHS funded stability studies. Cost-recovery – 90% recover costs fully/partly through budgets agreed with their trusts if that is budgeted or through income recovery or a combination of both and there were some facilities that actually have no idea of how costs are recovered.

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Who supplies and from where? 3. Outsourced / supply location

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Summary of current state outsourced / supply location

Who supplies and from where?

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3. O

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Supply chain options

• There are 180 known NHS Aseptic Facilities in England (excluding Radiopharmacies) and 17 sites that 100% outsource

• Aseptic Facilities have many different supply models; they vary by licensing, the extent to which the Trust outsources or supplies others, and whether the outsource suppliers are NHS or commercial non-NHS companies

• A third of Facilities are managing both significant in-house NHS preparation and purchasing outsourced commercial supply; most Facilities prepare under Section 10 since only 24% Facilities have an MHRA Specials Licence

• Trusts who have chosen to outsource did so for cost efficiency, investment, or capacity reasons. Recipient Trusts are more often choosing non-NHS Commercial suppliers for outsourced products, in lieu of other NHS Trusts

• Commercial suppliers currently tend to outperform licensed NHS suppliers in flexibility, responsive customer service, and economies of scale

Outsourced compounding (NHS / commercial supplier)

• Excluding CIVAs, overall at least 36% of aseptic compounding volume is outsourced to either NHS or non-NHS commercial suppliers: the rate of outsourcing appears to be higher for PN (49%) than chemotherapy (35%)

• This is likely to be an under-estimate of the level of outsourcing since some stakeholders have been unable to submit volume figures for outsourced supply

• Baxter, Qualasept Pharmaxo, and ITH Pharma are significant commercial suppliers to the NHS

• On average, the commercial supplier market has low, single digit operating margin (5.1%) and EBITDA** (6.5%) which restricts their ability to fund future capital investment and prompts suppliers to divest unprofitable product lines

Notes: ** Earnings before Interest, Tax, Depreciation, and Amortization; Source: NHS stakeholder interviews; Aseptic Facility data collection JAN 2018; Companies House; MINT UK

The NHS relies upon commercial suppliers for at least a third of aseptic compounding and the commercial supplier market is concentrated and highly competitive with low single digit operating margin (c.5%)

Presenter

Presentation Notes

- We found 180 NHS aseptic facilities across England (not including radiopharmacies) and 17 (9%) of these sites outsource 100%. Overall 36% of the total products are outsourced (PN = 51% and chemotherapy = 34%). Primary factors driving to trusts to outsource include: - failure or poor quality in-house equipment and estate - loss or inability to recruit key staff - outsourcing appears cheaper however nobody really has a good model of what this costs as often the in-house resource required to carry out a swift process is unaccounted for. - Recipient trusts are more often choosing non-NHS commercial suppliers as they tend to outperform licenced NHS facilities in terms of flexibility (as often nearby trusts have no capacity), responsive customer service (there is lack of prioritisation from an NHS supplier), and economies of scale. They have a more agile approach to hiring staff, allowing them the capability to quickly increase the numbers of low paid production staff. - One of the greatest myth busting this project has allowed is that the commercial sector is making a great deal of money from the NHS, when in fact low operating margins restrict their abilities for future investments and cause of disinvestment in low profit making lines. This may also explain the withdrawal from the market of two significant suppliers in the commercial sector and raises questions about assumptions that aseptic services can be outsourced and that current providers will stay in the market should they need to significantly upgrade their equipment/staff/premises (this has also been highlighted in the radio pharmacy community).

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Summary of current state outsourced / supply location

Who supplies and from where?

Who

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Licence status

• 82% of small to medium acute and DGH* aseptic Facilities are unlicensed by the MHRA and only 10% plan to get a MHRA Specials Licence. There is a trend of increasing product rationalisation and outsourcing

• 32% of large acute, teaching, and specialist hospital aseptic Facilities have a MHRA Specials Licence and an additional 13% are pursuing a licence so they can supply other Trusts

• On average licensed Facilities prepare c.51% of units under Section 10 and this is higher in licensed DGH Facilities (72%)

• There are different competencies required to manage a high volume, lean supply chain to produce batches of stock products under licence. In contrast, Section 10 products require more responsive, agile supply chains to rapidly meet bespoke demand. It may be more efficient and provide greater return on investment for Facilities to develop specialisation in either agile Section 10 preparation or lean Licensed production. Please see pages 30 to 33 for further details.

Geo coverage, supply consolidation, and contingency

• There is a significant flow of products between sites in and around the major metropolitan cities and 28 NHS Trusts supply other Trusts

• Trusts in London and the North have more customers over a greater geography; logistics may be suboptimal due to overlapping delivery areas

• Parts of the South, Midlands and East regions do not have any supply relationships between NHS Trusts because there is a lack of licensed Facilities in these geographical areas. However, several Facilities do have plans to apply for a Specials Licence

Notes: * district general hospital; ** Earnings before Interest, Tax, Depreciation, and Amortization; *** external to their organisation, other NHS Trusts, as well as providers in other UK home countries and commercial suppliers Source: NHS stakeholder interviews; Aseptic Facility data collection JAN 2018; Companies House; MINT UK

Many MHRA Specials Licensed NHS Facilities reported that they already supply customers***. There remains opportunity to optimise geographical coverage and maximise efficient batch production to achieve better return on investment

Presenter

Presentation Notes

- Efficiency not maximised as licensed DGH’s prepare in house on average 72% of units under section 10 (more responsive/agile supply chain meeting bespoke demand ) in comparison to competencies that are required for production of stock products under a license. Most of the facilities prepare under section 10 since only 24% have a specials license and trends show that small to medium acute and DGH -82% of these are unlicensed and 10% only intend to get a license. More product rationalisation and outsourcing commercial suppliers but some lack the QMS required to get a license. Those which outsource are standardising their portfolio and outsourcing more to commercial suppliers, where possible. Large acute, teaching and specialist 32% of these have a license and an additional 13% are pursuing a license with the main driver being the need to supply other trusts. (some focus on bespoke products in house and outsource other) NHS supplier trusts are linked to their customers via England’s major motorways (M40 and the M6) being the primary routes of customer supply relationships and all 100% outsourced sites are located near to these major roads. The network where commercial suppliers are used is huge across the country and follow no major pattern for supply. Our findings didn’t have the capacity to look at regional hubs for these companies and would be one of the areas that would require more granular information.

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How is supply managed? 4. Staff

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Summary of current state staff (1 of 2) Aseptic preparation is a labour intensive process and many Aseptic Facilities face significant problems with workforce recruitment, training, and retention. 103 out of 180 Aseptic Facilities have at least one vacancy

How

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4.S

taff

Staffing models

• MHRA Specials Licensed Facilities have a greater proportion of band 2 to 4 staff and a lower average labour cost; S10 Facilities use more time from Technicians and band 7 to 8 Pharmacists

• The proportion of staff per band also varies per region: the North uses the highest proportion of bands 2 to 4; London has the highest average labour cost due to the High Cost Area pay supplement

• Task allocation per staff band varies considerably, the most variable tasks are: aseptic service verification, first check, and in procedure checks

• It is likely that some of the variation across Trusts is unwarranted and productivity could be increased by increasing economies of scale in (existing and newly) licensed Facilities and identifying good practices from high quality low cost services

Recruitment & training

• Staff turnover is high (15-20%), particularly for operator roles in the Midlands and South, and turnover is costly due to the significant time and expense to recruit and fully train new staff

• The time to train new Assistants and Technicians varies from <2 weeks in large London Facilities to 5 to 7 weeks elsewhere. Further analysis is needed to evaluate the quality of training and whether there is opportunity to spread adoption of training materials

• There are vacancies at all junior bands, and band 7 has the highest vacancy rate (c.14%). Although this is in line with the overall NHS vacancy rate, it is higher than the rate for Pharmacy as a whole (c.8%), which may indicate a poorer perception of Technical Services

• Anecdotally the Carter Report has further increased the attractiveness of Clinical Pharmacy as a career choice for Pharmacists, to the detriment of Technical Services

• Band 4 and 6 staff are sometimes rotational roles, but the majority of staff do not rotate • Pharmacist rotations can help expose more staff to Aseptic Services as a future career

specialisation, but this must be balanced against the additional time to train rotating staff

How is supply managed?

Source: NHS stakeholder interviews; Aseptic Facility data collection JAN 2018

Presenter

Presentation Notes

Staff banding, average labour costs, task allocation by staff band and training are determined by geographical location and by license status of an aseptic unit. For example the North region uses the highest proportion of band 2-4 staff. S10 facilities use more time from band 7/8 pharmacists and technicians, whereas specials licensed facilities leverage a greater proportion of band 2 and 3 assistants. London has the highest average labour costs, as expected, due to the high cost area pay supplement – which raises the question that should we think about relocating facilities to a low cost area outside the M25? task allocation per staff band varies considerably. The most variable tasks are: aseptic service verification, first check and in procedre checks-further analysis is required to identify good practice in the allocation of staff. Depending on where you are located your training can vary anywhere between <2weeks (London) up to 7 weeks (south). The turnover rate is very high, with vacancies existing at all junior and band 7 levels. The turnover rate @ 15-20% exceeds the average for British manufacturing sectors, pharmacy as a whole and the NHS overall – is this due to the rotational nature of these roles, the lack of promotion, a greater move towards clinical activities? All these factors need more consideration to determine if role enrichment, career planning, or better workload planning is needed. (esp in the midlands and the south) One case study highlighted is that of Barts and the London who have redesigned their training pathway to upskill and retain existing production Assistants, to deepen the level of expertise of operators, and to attract a broader range of people to work in Aseptic Services (e.g. science graduates). Apprentices are permanent employees and learn how to manufacture products over a 2 year programme that combines college-based learning with work placements and study Following completion of the course, Apprentices are qualified as NVQ Level 3 Scientific Manufacturing Technicians and are able to register with the Science Council. This has allowed a reduction in training period, reduction in labour cost per dose, staff turnover, frees up existing technicians for other roles and can be offered immediately.

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Summary of current state staff (2 of 2) H

ow is

sup

ply

man

aged

?

4.S

taff

Workforce capacity

• There is no consistent methodology to calculate staff capacity, so results are incomparable. A single methodology is needed in order for future NHS supply networks to understand their collective resource base and compare productivity fairly

• Facilities report an average staff capacity of c.85% and c.60% Facilities perceive that a lack of staff capacity prevents them from offering desired services

• 35 Facilities want to make CIVAs, but cannot or have scaled back due to pressure to meet core demand

• In addition, small to medium acute / DGH Trusts are constrained by inability to recruit Pharmacists and high production staff turnover and training burden

• Overtime is a weekly occurrence for 41% Facilities and is attributed by stakeholders to chronic late prescribing, unpredictable demand, and upstream disruptions – as well as staff capacity consistently lagging increase in demand

• Monday to Friday, the vast majority of Aseptic Services are open from 8:30 to 17:00. Further analysis is needed to evaluate if there is a “quick win” opportunity to release capacity by staggering staff shifts for an earlier start-up and later close-down

Succession plans & careers

• Each Facility relies on a small number of highly qualified key individuals for leadership and QMS and the slowing pace of advancement at senior bands may cause band 7 staff to leave to progress their careers

• Succession is an issue for Accountable Pharmacists, QPs, and Regional QA posts • Accountable and Authorised Pharmacists have been in role on average 13 years

(median) and some may be nearing retirement • Outside of London there are insufficient QPs in training to replace existing QPs and it is

commonplace for newly certificated QPs to leave for better paid roles at Pharma Companies

• A strategy is needed to develop a career pathway for all roles and bands of the Aseptic Service workforce, to attract, develop, and retain knowledge and talent within the NHS


Lack of staff capacity is preventing c.60% Aseptic Facilities from offering desired services and a standard method to calculate capacity is needed to plan for national and local workforce requirements


Presenter

Presentation Notes

Major finding is that there is no consistent methodology to calculate staff capacity and different facilities remove different activities from the ‘available’ staff calculation creating even more diversity in the standard calculations. MHRA published capacity guidance in 2015 detailing that units should run between 70-80% to allow adequate resource for associated ancillary tasks, where compliance to this should be assessed at a minimum monthly during management review and reviewed at least annually A tool verified in NHS Scotland is available and various regions are working towards a standard capacity calculation (through devo-manc work and the PASG are working on this as part of their years strategy-TBC) What we found was that < 50% of trusts approved the capacity plan at a senior level in their trust, and of those that approve their capacity , most review it less frequently than every month and 60% of these facilities have been prevented from offering desired services as a result of staff constraints and lack of capacity. More than half of facilities are working overtime every week in the south. Due to staff capacity lagging demand increase, manufacturing being prioritised in normal hours, and staff absences and sickness. Succession- retirement does not appear to be a significant driver of succession issues. There is a lack of career opportunities may cause band 7 pharmacists to leave aseptic services. In addition, there are a small number of QPs to sponsor trainees and few authorised Facilities where trainees can gain the requisite IMP manufacturing experience. There is therefore an opportunity for NHS Trusts to work together on a strategy to train and retain QPs in the NHS and enhance the recognition of the role there are insufficient QPs in training to replace existing QPs.

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How is supply managed? 5. Estate, equipment, and automation

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Summary of current state estate, equipment, automation An in-house NHS Aseptic Service is asset intensive: estate and equipment needs ongoing maintenance and periodic renewal, so high utilisation is preferable to maximise return on investment

How

is s

uppl

y m

anag

ed?

5.E

stat

e, e

quip

men

t & a

utom

atio

n

Facility and equipment age, utilisation, and condition

• Aseptic Facilities tend to be owned by the Trust (75%) and are more than halfway through the design life but despite their age, most stakeholders report that walls and benches of Facilities are in good condition

• There is correlation between advancing age and deteriorating condition of estate • There is an installed base of 403 workstations* and equipment is typically near the end of

its design life and needs replacement or renewal • Laminar flow cabinets tend to be older and in poorer condition than isolators /AHUs • Layout & spatial proportions of estate and poor reliability of equipment have

prevented 37 Facilities from offering desired services • There are workstations that are significantly under-utilised during current opening hours

• Whilst equipment in Licensed Facilities has slightly higher utilisation, this could increase further to maximise efficient batch production

• There are 219 pieces of equipment not in use, of which 167 are in working condition and are awaiting validation, being retained as a contingency, or used to train new staff

Capital investment e.g. Facilities, automation

• New Facilities can be delayed or low quality when built by contractors that lack clean room experience and in-house Estate teams may lack resources and guidance

• Since new Facilities and equipment are installed very infrequently, there is insufficient local experience to plan, manage, and trouble-shoot projects. There is opportunity to centralise expertise and knowledge

• 12 NHS Aseptic Facilities (10%) have deployed 28 basic volumetric filling pump automation solutions for PN and CIVAs preparation. Currently there are no instances in England of high volume efficient batch production of aseptic medicines with robots

Maintenance and QMS

• The majority of Facilities were unable to provide for this review either maintenance or servicing costs, which is symptomatic of a generally poor understanding of the cost to provide in-house Aseptic Services

• Quality Management Systems (QMS) are sometimes deprioritised by senior leaders due to the pressure to prepare products to meet demand and patient needs


Notes: *workstations are the equipment where aseptic manipulations takes place and includes isolators and laminar flow cabinets Source: NHS stakeholder interviews; Aseptic Facility data collection JAN 2018

Presenter

Presentation Notes

Aseptic facilities are usually owned by the trust and the majority of these have installed isolators in preference to laminar flow cabinets. Aging facilities are found across all of the 4 regions irrespective of an urban or rural location. A direct correlation can be seen between advancing age of a facility and the deteriorating condition of the estate. Despite this, most stakeholders report that walls and benches of facilities are in ‘good’ condition. Estate and equipment have prevented some facilities expanding core services or supporting clinical trials –with 37 facilities have been prevented from offering desired services. Quantity and quality of data is insufficient to benchmark facilities in a peer group with similar number and condition of equipment or grade of clean rooms- symptomatic of a poor understanding of the cost per unit of different NHS and non-NHS commercial suppliers to inform supply chain choices. Workstations are significantly under utilised during current opening hours –alternative supply models may improve utilisation of expensive assets. 219 pieces of equipment are not in use, of which 167 are in working condition-awaiting either validation, being retained as contingency, or used to train new staff. There is anecdotal evidence from regional QA that accountable pharmacists lack the knowledge and experience to validate new equipment since equipment is renewed so infrequently. 12 NHS aseptic facilities have deployed 28 basic volumetric filling pump automation solutions for PN and CIVAs preparation and currently there are no instances of high volume efficient batch production of aseptic products with robots.

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How is supply managed? 6. Logistics, planning, and control

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Summary of current state logistics, planning, control H

ow is

sup

ply

man

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6. L

ogis

tics,

pla

nnin

g, &

con

trol

Stock levels, waste, and recycling

• There are many points in the supply chain for waste to occur and it is inconsistently and poorly tracked. Wasted stock is not routinely reimbursed so many Trusts are potentially losing money

• Possible solutions include improvements to: ordering visibility, demand volatility, stock management, risk assessment, risk reduction, and contingency arrangements

Prescribing practice & clinical planning e.g. 2-step chemo

• Disorganised clinical practices are a key driver of waste, aseptic service inefficiency, and unwarranted variation Late prescribing, unpredictable demand for PN, and upstream disruptions to booking and scheduling have a knock-on impact on aseptic preparation

• Successful waste reduction initiatives have been driven by collaboration between aseptic service managers and clinical leadership

• Small hospitals have disproportionately higher waste due to lower and more variable demand

IT systems

• 33% Facilities have electronic prescribing systems (EPMA) in key clinical areas, and this rises to 85% for cancer care

• For all product categories, production management and quality management is largely manual. A small number of Facilities have developed their own in-house solutions for label generation, quality management, and production management

• Information flow is critical to ensure timely demand visibility for agile Section 10 preparation. There may be good practice in-house or open source IT systems that could be scaled up

Logistics

• Most Facilities transport aseptic products to other sites using the Trust’s fleet of vehicles but 45% of Facilities only use aseptic products on the same site where they are made

• Best practice cold chain logistics can reduce waste by enabling unused stock products made under licence to be returned (see page 150 for a case study)


Digital systems and collaboration with clinicians are critical to reduce waste, to control and share stock, and to optimise the timely flow of products, information, and prescriptions


Presenter

Presentation Notes

Drivers of waste – patient is late/no show, not suitable for treatment , expiry of products made under license for stock, breakage , spillage, or staff error due to complex manipulations, contamination/equipment failure/break in cold chain One particular unit said that in order to prevent waste they went back to manufacturing on a named-patient basis and not using the dose-banded chemotherapy. Information flow is critical to ensure timely demand visibility for agile Section 10 preparation. There may be good practice in-house or open source IT systems that could be scaled up Interoperable systems are not available- a roadblock to potential service delivery redesign. 45% of facilities only use aseptic products on the same site where they are made-best practice cold chain logistics can reduce waste by enabling unused stock products to be returned.

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Next Steps Radiopharmacy data not included, although findings are highlighted where relevant

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Next Steps 1. Review of the detailed dataset by the Chief Pharmaceutical Officer and commissioning of

a Strategic planning group to develop and implement recommendations

2. Development of metrics for regular data collection

Draft metrics for discussion Selected metrics are feasible (low burden and technically possible) and collected with high coverage and good quality

What is supplied?

2.Products & materials 1. Needs & trends

What is the demand?



6. Logistics & ordering 4.Staff 5.Estate, equipment

& automation

Dat

a te

mpl

ate

wor

kshe

et &

ana

lyse

s

Product portfolio

Volume made in-house under licence or S10

Chemo standardisation

PN standardisation

Facilities + equipment

IT systems to manage workload planning and ordering

Outsourcing + collaboration Product portfolio

Number and names of customers and suppliers

Level of outsourcing

Intro + tracker

Future licence plans

Quality + risk

EL Audit and MHRA Audit overall risk rating

Staff

Number of QPs and QPs in training

Vacancies per band and role

Turnover

Staff capacity

Overtime

Hours of training

Opening hours variation

Facility + equipment

Age of isolators/cabinets and condition

Utilisation of equipment

Use of high volume batch automation

Would require alignment on a single methodology to calculate capacity

Presenter

Presentation Notes

There are many uncertainties affecting staffing numbers which need further analysis: future ATMP models, approach to outsourcing and supply networks, approach to unmet need, uptake of innovative staffing models, and uptake of automation

26

Next Steps 3. Several key questions require further information gathering at a local level

Source: NHS stakeholder interviews; Aseptic Facility data collection JAN 2018; Deloitte analysis

Future state: strategic options

Question Gaps in knowledge Comparison of cost per unit for in-house manufacture and identification of high quality low cost providers

• Full cost of in-house preparation / production attributable to product category (key costs such as maintenance, servicing, utilities, and depreciation are unknown)

Financial savings from robotic automation • Incremental efficiency gained from automation is unknown (accurate studies have not been undertaken) and return on investment needs further evaluation

Career development and training options for workforce

• Methods to engage and develop workforce need further exploration with Health Education England, Deans, Technical Specialist Education and Training group, and stakeholders

Identification of number and location of future regional supply hubs and evaluation of ability to meet standards for audit, QA, and licensing

• Although we have identified supplier recipient relationships, a significant number of these did not provide volume information – therefore we could not determine the location of current major supply hubs

• The majority of Trusts do not have EPMA and were unable to articulate the level of local demand for aseptic products, future work could link demand to types of patient and service

• Future hub locations should take into account the sites that win the national procurement for genomic laboratories

Quantifying savings opportunities for outsourcing

• High quality time and motion studies are not consistently available for a) efficient in-house production per product category, and b) well-managed outsourced supply management

• Full cost of in-house preparation/production attributable to product category (key costs such as maintenance, servicing, utilities, and depreciation are unknown)

Quantifying savings opportunities for waste reduction or a planned equipment replacement programme

• In interviews and data collection responses, stakeholders were unable to provide quantitative results from waste reduction initiatives

Quantifying number of workstations needed given optimal utilisation, quality, safety, and transfer of equipment between Trusts

• Local and regional evaluation of workstation utilisation is needed to analyse how to maximise the use of assets whilst maintaining appropriate segregation between product categories, optimising product flow, and protecting sufficient time for QMS

• Trusts don’t have a standardised methodology for calculating workstation utilisation

Future workforce numbers • There are many uncertainties affecting staffing numbers which need further analysis:

future ATMP models, approach to outsourcing and supply networks, approach to unmet need, uptake of innovative staffing models, and uptake of automation

Documents

Pharmacy Aseptic Services Review Summary of Key Findings · • What is the current state and level of variation? • What are the reasons for variation (warranted and ... Secondary