The Ocrelizumab Pharmacy Service at the Leeds Teaching Hospitals NHS Trust (LTHT): Improving the Patient Experience

Jeremy Robson & Sumrah Shaffiq, Leeds Teaching Hospitals NHS Trust Neurology Academy MS Advanced MasterClass 9.2

Background

In 2018, the approval of Ocrevus (ocrelizumab) offered another treatment option for the management of relapsing remitting Multiple Sclerosis (RRMS)1, but the breakthrough decision came in 2019 upon its approval for early primary progressive MS (PPMS)2.

The West Yorkshire MS Treatment Programme (WYMST) was set up to centralise a multi- district clinic and provides an effective model to ensure appropriate and equitable treatment for people with MS3. The WYMST has approximately 600 RRMS and approximately 100 PPMS from Leeds. Patients eligible for ocrelizumab are consented by the MS team and the prescribing is undertaken by independent pharmacist prescribers (IPPs). Ocrelizumab is administered on the LTHT day case unit, which is also used for the management of other neurology conditions. The IPPs contribute to the prescribing for these patients. Prescribing of ocrelizumab is undertaken on paper drug charts.

At LTHT, the compounding of a majority of monoclonal antibodies (MAbs) (e.g. rituximab, alemtuzumab, infliximab, ocrelizumab) are overseen by the aseptics department. This is the default position to guarantee a sterile product and also mitigate the potential risk to staff members. This part of the service review involved challenging discussions between the IPPs, their aseptics colleagues and the MS team.

The approval of ocrelizumab for RRMS and PPMS means a potential increase in prescribing, day case admissions and aseptics involvement in the manufacture of MAbs. A service review was warranted to establish if the current approach ensured the LTHT ocrelizumab service was efficient, safe and patient-centred.

Aim: To review the WYMST ocrelizumab pharmacy service on the day case unit

Objectives • To understand the patient experience of those receiving ocrelizumab on the day unit • To ensure a timely availability of ocrelizumab infusion • To establish the safe and appropriate place to compound ocrelizumab infusions • To ensure safe and effective prescribing ocrelizumab

Method Patient feedback via paper questionnaires on the unit was sought to set to help identify the patient needs of the LTHT ocrelizumab service. Figure 1 provides an overview of the most common comments. The UK Clinical Pharmacy Association (UKCPA) Neurology email group was used to establish how other trusts managed their service and how ocrelizumab was compounded.

In addition, a retrospective review of all patients initiated on ocrelizumab during the period of 1st November 2018 to 31st December 2019 was conducted. The primary focus was the time taken to prescribe ocrelizumab on the paper drug charts and the time taken for the aseptics process in manufacturing and delivering ocrelizumab. Data on the time was attained via the use of the Pando4 application, a communication tool that enables encrypted messaging. The Pando application was used to notify the pharmacy team when a patient is fit for treatment and enabling orders to be sent to aseptics. The time in motion techniques was used to establish the time taken for the IPPs’ prescribing on paper drug charts.

Results A total of 63 RRMS patients had ocrelizumab infusions between 1st November 2018 and 31st December 2019, some of which had subsequent doses, and equated to a total of 92 doses of ocrelizumab.

The average time for the ocrelizumab to be delivered to the day unit once the patient was deemed fit for therapy was 155 minutes, with a shortest time of 63 minutes and the longest time 289 minutes. Figure 2 illustrates the time taken for ocrelizumab to arrive on the day unit for all the 92 doses administered.

With regards to IPP prescribing, it took approximately 10 minutes to prescribe a dose per patient on a paper drug chart, including the pre-medications.

Figure 1: Time taken for ocrelizumab to arrive to the day unit from aseptics

Discussion

The overall patient experience of the day case was good, with comments referencing fantastic staff engagement, the great atmosphere on the unit and good quality and accessible information. See figure 2 for some common themes. The one area for contention was the time taken for the ocrelizumab infusion to arrive from the aseptics unit upon the patient being deemed fit for treatment.

Figure 2: Feedback from Day Case Patients in 2020

13 out of the 15 colleagues who responded stated the ocrelizumab was compounded on their respective units by the nurses; making LTHT an outlier. The day unit managing the preparation of ocrelizumab is likely to reduce patients’ waiting time. The IPPs liaise with aseptics to review the risk assessment of compounding MAbs in clinical areas. We used our data to revisit these discussions with and were informed aseptics will still compound ocrelizumab.

Although the time in motion data illustrated prescribing was not an arduous task but due to a number of factors, a review was needed. Such factors included the potential waste of paper charts as the indefinite use of ocrelizumab would require numerous paper charts, as there is only space for 3 doses, leading to waste. Furthermore, there are 2 different ocrelizumab regimens (induction and maintenance) thus potential for a prescriber error with a paper prescribing. Furthermore, given the digital transformation of the NHS there is a drive to move toward a paperlite system, thus reviewing the current prescribing method (i.e. paper drug chart) is prudent. Information relating to prescribing processes was not gathered from colleagues due to the availability of different electronic prescribing systems.

LTHT utilises a number of electronic prescribing systems in all other clinical areas, one of which is ChemoCare. ChemoCare is utilised to prescribe chemotherapy electronically, with an integrated scheduling system and provides individual patient records. Once a patient is assigned on ChemoCare the time to prescribe subsequent doses is likely to be more efficient. Currently ChemoCare is being trialled as the prescribing system for ocrelizumab. The IPPs have trained the MDT involved on ChemoCare and ensured appropriate IT facilities in all the necessary areas (e.g. day unit, neurologists’ and pharmacy team’s computers). Initial results from the pilot, have demonstrated ChemoCare provides a more efficient and safer prescribing system however the orders still need to be printed and faxed to the aseptics unit.

LTHT pharmacy aseptics, initially risk assessed ocrelizumab as must be compounded in an aseptics unit due to limited evidence regarding the late adverse effects of occupational exposure to MAbs. There is a potential risk of occupational exposure to healthcare staff from the ingestion of liquid aerosol during the preparation of any liquid MAb, including a risk of chronic low-grade exposure due to the handling of multiple MAbs over a period of time 5, 6.

Using the data, patient feedback and gaining insight into how other MS centre compound ocrelizuamb, allowed the IPPs to re-visit the risk assessment of ocrelizumab. The aseptics management team reviewed the above data and up to date evidence. The updated risk assessment still concluded that ocrelizumab must be made in a pharmacy aseptic unit.

With the focus on the patient experience, subsequent discussions between the aseptics service, IPPs, pharmacy management and neurosciences management offered a compromise of pre-making ocrelizumab. Pre-made ocrelizumab offers the confines within its 24 hour expiry and have the product on the day unit in advance of the patient’s appointment. It was agreed the patient experience outweighed the financial risk, should a dose have to be wasted if a patient is not deemed fit for treatment. The review of the pilot is still on-going and it is hoped that this will generate further discussions.

This project concentrated on the pharmacy service to ocrelizumab and the rest of the MS team are keen to review the rest of the ocrelizumab pathway.

Recommendations

• To extend the review to include the whole ocrelizumab pathway to investigate if any improvements can be made.

• To review pre-made ocrelizumab pilot has the benefit of improved patient experience outweighed the financial risk.

• To review the ChemoCare pilot with the neurology MDT – does it offer the most efficient electronic prescribing tool/method and consider using it for other day case treatments (e.g. natalizumab, rituximab, cyclophosphamide).

• To collaborate with the aseptics unit to establish an electronic alternative to ordering ocrelizumab.

• To revisit the possibility of ocrelizumab being compounded on the day unit, with possibility of making the day before scheduled day unit visits.

References

1. NICE Relapsing Remitting MS June 2018: https://www.nice.org.uk/guidance/ta533

2. NICE Primary Progressive MS June 2019: https://www.nice.org.uk/guidance/ta585

3. Ford, H.L., Johnson, M. and Fear, J., 2002. A multi-district model for the management of disease- modifying treatments in multiple sclerosis. British Journal of Clinical Governance. LTHT. 2014.

4. Pando 2020. Communication for health & social care. Available online: https://hellopando.

5. Alexander M, King J, Bajel A et al, 2014. Australian consensus guidelines for the safe handling of monoclonal antibodies for cancer treatment by healthcare personnel http://edcan.org.au/assets/edcan/files/Alexander_et_al-2014-Internal_Medicine_Journal.pdf

6. Halsen G & Kramer I, 2011 Assessing the risk to health care staff from long-term exposure to anticancer drugs--the case of monoclonal antibodies. J Oncol Pharm Pract. 2011 Mar;17(1):68- 80.https://doi.org/10.1177/1078155210376847