We know how to adapt our treatments to meet the specific needs of healthcare institutions and their patients.

You may have heard about the upcoming supply issues of the Bristol Myers Squibb (BMS) Orencia pre-filled pen devices for treatment of moderate to severe rheumatoid arthritis.

Despite this issue, our team are able to offer Orencia treatment through IV infusion to minimise disruption to patients and avoid operational burden to NHS trusts and health boards.

We know the importance of medication integrity and timely delivery in patient care.

Our team of registered nurses have capacity to support a full increase in demand for the administration of Orencia® IV infusion at home whilst there are ongoing supply issues of the Orencia pre-filled pen devices.

We are offering an IV infusion option for Orencia 250 mg powder for concentrate for solution for infusion to all suitable Orencia patients, meaning patients needn’t worry about delays in treatment during this time.

We understand this change can create uncertainty and we apologise on behalf of BMS for any inconvenience, but rest assured we are doing our best to help. We will keep you updated as we find out more.

We know the impact of a change to routine and the impact on patients lives. Our team have been collating FAQs for patients and Trusts to support in the process and we will add more FAQs as we all learn more.

If you have questions for us in relation to the Orencia issue please contact us directly at OrenciaFAQ@Lpclinicalhomecare.co.uk

 

Operational process for Orencia

The following points have been formulated for use with patients and customers by our front-line colleagues following the communication of the imminent stock outage of the Orencia Pre-Filled Pen. 

What’s the problem?

The pharmaceutical company Bristol-Myers Squibb Australia (BMS) has notified us of shortages of both Orencia (abatacept) 125 mg/mL products for subcutaneous administration: 

  • ClickJect (autoinjector), In shortage 8 May to 30 August 2024
  • Prefilled syringe, In shortage 8 May to 30 September 2024

The ClickJect (autoinjector) is in shortage due to manufacturing delays. The prefilled syringe is in shortage because of an expected increase in consumer demand.

What does this mean?

The shortages are only affecting the Orencia subcutaneous presentations. There is sufficient stock of Orencia 250 mg intravenous (IV) to support patients currently receiving it, this means that some patients will be switched to an intravenous preparation to enable them to continue their prescribed treatment.

How long is the supply outage expected to last?

We anticipate the outage to last for a minimum of 20 weeks and commences from 21st June 2024.

How is the decision being made on which patients will receive a pre-filled syringe or infusion service?

LPCH has undertaken various investigations of our current active patient cohort receiving Orencia medication in collaboration with the manufacturer and clinical teams. The following patients will be prioritised to receive the pre-filled syringe:

  • Paediatric patients
  • Patients over the age of 88
  • Patients in remote locations where nursing is not easily accessible.
  • Patients with a diagnosis of Morphea

What happens after the supply outage is resolved?

Patients will be switched back to their previous device as soon as practicable. Our Patient Services team will be contact to arrange the switch and supply of your medication when this becomes available. Your delivery frequency will resume in 4 weekly intervals. 

Nursing Specific FAQs

What is an infusion?

An infusion is a way of administering medication directly into the bloodstream through a vein. This process involves using an IV (intravenous) line, which is a thin, flexible tube placed into a vein in the arm. 

1. Preparation: Before the infusion, a nurse will perform a health check to ensure everything is in order.

2. During the Infusion: 

  • A nurse will insert a small IV catheter into a vein in the arm or hand.
  • The IV line will be connected to a bag of the Orencia solution.
  • The medication will then drip slowly from the bag through the IV line in about 30 minutes to an hour for Orencia.

3. Monitoring: 

During the infusion, the nurse will watch for any potential side effects.

4. After the Infusion: 

Once the infusion is complete, the IV line will be removed, and the patient observed for a short period to ensure there are no immediate reactions.

5. Frequency: 

Infusions of Orencia are usually done every four weeks, like the schedule with subcutaneous injections.

In relation to the timings of IV administration offered to patients. Do you offer evening and weekend IV service for Orencia?

We are offering 8am – 6pm 7 days a week for the duration of the project.

Will the product be reconstituted at bedside or aseptically? Licence states administer immediately but wondering if you had stability data?

It will be reconstituted bedside; it is only stable for 24 hours between 2-8 degrees after reconstitution and wouldn’t be suitable to go through the compounding process.

Will we need a new SLA and paperwork for the switch to IV. When does this need to be switched by?

A variation letter is suitable. 

Patient Specific FAQs

Are the side effects the same as the injections?

Yes, the side effects of Orencia (abatacept) can be similar whether it is administered as an injection (subcutaneous) or as an infusion (intravenous).  While the overall profile of side effects of the subcutaneous injection and intravenous infusion is similar, the main difference lies in the type and timing of reactions related to the method of administration. It’s essential that any adverse events continue to be reported through our usual AE reporting processes.

Why am I changing to an infusion service before the outage is due to start?

The process involved in switching patients from a dispense and delivery service to an infusion service requires significant input from our front-line colleagues and therefore we want to mitigate any risk to patients by commencing the switch in service ahead of the outage. This also allows us to protect the current supply of pre-filled pens for as long as possible.

Why can’t I change to a pre-filled syringe instead of the infusion service?

The majority of Orencia patients are currently using pre-filled pens. The decision to move patients to an infusion service has been made to prevent any further supply outage on the pre-filled syringe. There is a limited supply of this alternative device and only patients who meet strict criteria as defined by the manufacturer will be able to switch to a syringe supply.

How will my nurse visits be arranged?

A nurse will contact you by phone ahead of your estimated next delivery date to arrange a suitable nursing visit. Once this has been confirmed, it’s important you are available for both your nurse visit, and to accept the delivery of your medication. 

Will my delivery date or frequency of deliveries be changing?

Most of our patients are currently receiving their deliveries on a 4-weekly basis – there will be no change to this frequency of delivery. Patients will receive a 4-week supply of medication and ancillary items to enable a weekly nurse infusion visit. 

How will my deliveries be arranged?

Our Patient Services team will contact you at least 7 days prior to your first nurse visit in a 4-week period to arrange delivery of your medication and ancillary items. We will aim to deliver your medication 3 days prior to your nurse visit. It is vital that you or an authorised signatory are available to accept delivery of this medication.

Will I be visited by an LPCH Nurse?

We are partnering with an external nursing agency to support our patients during the outage. You may be visited by either an LPCH nurse or an agency nurse during this time. 

Trust Specific FAQs

As patients have not been weighed by the hospital recently, can we ask patients to contact their clinical team with their current weight via the patient letter?

The clinical team will need to contact their patients. The patients’ weight is the responsibility of the prescriber. 

When will we start to get a report of the status of our patients? How often will this be sent? Do you need the Trust to provide the names/emails of where this should be emailed?

We will send patient visit forms for all patients following each infusion. 

Before I take to Trust board could you send me SLA for IV and nursing documents to support? Third party company…who will these be, and would they be following LPCH nursing SOPs or their own Companies SOPs?

The Agency Nurses will be provided training in LPCH’s processes and will utilise LPCH’s standardised Patient Visit Forms.

Is LPCH able to temporarily switch all the PFP patients to IV from a capacity perspective?

LPCH has all the relevant resource aligned form a capacity perspective to support patients with this switch where applicable.

Have you done home admin for this before? Are there any risk assessments that have been done for this?

Whilst we have not administered the intravenous preparation for Abatacept in the home environment, we have extensive experience in providing and administering intravenous infusion with a full range of complexity that extends to systemic anti-cancer treatments and blood products. A full risk assessment has been completed on this molecule, in addition all nurses are BLS and anaphylaxis trained and carry the required emergency medications.

There is also potential that Trusts may move patients from another homecare provider to yourselves to use the nurse administration element as some of the other providers do not have capacity for this. Is this on your radar? 

LPCH have had experience of managing shared care arrangements with other Homecare providers and clinical referrers and will refer to the NCHA’s guidance to support these requests when required.

I understand that LPCH will be supporting us to identify which patients can switch to the PFS and who will need to be switched to IV infusions. Please can we arrange a meeting as soon as possible to plan this?

If trusts would like a meeting with LPCH to support, this is available and contact via the normal routes should remain. However, currently any patients that are receiving a PFP for Unlicensed use, Morphea diagnosis, paediatric or 88years and older, will receive PFS. All other patients will be offered the IV service – unless LPCH are provided clinical reason to not offer IV and this will be reviewed by the LPCH clinical panel twice weekly. 

When are the very last deliveries of PFP’s made, required so that we are able to prioritise getting the prescriptions signed?

Due to expire week commencing 24th June 2024.

Do you also have a clinical protocol that the nurses will use for IV home infusions?

Yes, guidance specific to this preparation is in development for the nursing teams.

Will the product be reconstituted at bedside or aseptically? Licence states administer immediately but wondering if you had stability data?

It will be reconstituted bedside; it is only stable for 24 hours between 2-8 degrees after reconstitution and would not be suitable to go through the compounding process.

Are Lloyds willing to annotate prescriptions with the required changes?

We can only annotate an existing prescription for the movement from PFP to PFS (assuming no dose changes). We will need a new prescription for all patients moving to the infusion.

Will Lloyds be notifying patients of this change? If so, will that be via letter or phone call when booking in the next delivery?

LPCH will be communicating with patients the first week of June directly after communications to the patients trusts.

Are you able to confirm what percentage if any of MFT pts can go onto PFS and when this supply will run out? Could pts end up switching to PFS and then IV then back to pen? What actions do we need to take? do we need to prepare our pts that they will need to go onto IV after 23/06/2024?

Comms to trust is paediatric, Scotland, Morphia and patients over 88 years will be supported in PFS switch via RNT. All other patients will go from PFP to IV then return to PFP when the stock supply is resolved.

Following receipt of the above alert we are writing to ask how many of our ABATACEPT patients you will be able to switch to the PFS?

Comms to trust is paediatric, Scotland, Morphia and patients over 88 years will be supported in PFS switch via RNT. All other patients will go from PFP to IV then return to PFP when the stock supply is resolved.

Will LPCH pre-populate IV Infusion prescriptions when template is available?

Yes, LPCH will be providing trusts with pre-populated templates for the patients who will be switching to IV Infusion.

Will the IV infusion be delivered with the nurse or separately?

The Drug along with all required ancillary items will be delivered directly to the patient. The nurse will then reconstitute the infusion at the patients home and administer.

What type of nurses are going to be used (lpch and agency)?

Both, LPCH and agency nurses.

Training level to be proven?

All nurses will have a competency document and agency nurses will complete a self-certification for the skills required. all nurses will be qualified and hold a registration PIN number with the NMC.

How is the Orencia infusion going to arrive at the patients, delivered separately or brought by nurse?

All ancillaries and the drug will be delivered to the patient ahead of the nurse visit as normal process within LPCH. 

Are you producing an SOP on the nursing provision?

LPCH nurses will work within the guidance provided in both the SOP provided for the service alongside internal work instructions, agency nurses will work within a dedicated work instruction provided for this service and will be provided with a digital pack of all work instructions required to complete these visits.

The risk of ADR/ anaphylaxis is higher with infusion, what is the process for nurses dealing with this?

All will have been BLS trained and trained to recognise and deal with hypersensitivity reactions and anaphylaxis. All will carry and emergency drugs kit.

Are the nurses trained to deal with Anaphylaxis / do they carry kits?

All will have been BLS trained and trained to recognise and deal with hypersensitivity reactions and anaphylaxis. All will carry and emergency drugs kit.

Can your compounding unit make abatacept and supplying to us as ‘ready-made IV infusion bags’?

No. The only treatments we can offer given the short time periods are only as per the recent communication – a prefilled syringe or the Orencia infusion.

If we arrange a clinic in the hospital for several patients to attend, could one of your nurses attend the hospital to support the administration rather than visit patients in their own home?

At LPCH, we offer a convenient homecare service where a registered nurse visits patients at their homes to administer IV infusions on their treatment due dates. To provide hospital-based care would involve a lengthy administrative process to obtain honorary contracts. However, please note that altering a patient’s treatment schedule to align with a clinic date may have implications for adverse event reporting.

How long would you recommend the prescriptions are written for? Is it likely that deliveries of PFP’s will resume in September, i.e. should we just have the prescriptions written for 3 months or is it likely to last longer, therefore a 6-month prescription might be a better option so that we don’t have to repeat the exercise of having a massive batch of prescriptions again in 3 months’ time?

BMS stated 19 weeks of supply disruption which is almost 5 months. LPCH would prefer a 6-month duration Rx if clinically appropriate, so we don’t have to repeat the Rx renewal exercise again. This should work to the advantage of the NHS customers as well.  If supply of PFP was reinstated, we would void the remaining infusion supplies and change to pen again.  

How are we going to check that the IV infusion is correct for the patient, will it be asked on a setup call, or will it be when the nurse arrives?

The responsibility of weighing patients will remain with the prescriber. Since a patient’s weight is necessary for prescribing IV Abatacept, it must be obtained before the nurse’s visit.

The Patient Letter only references pre-filled pens? As the shortage will include pre-filled syringes, can his be amended?

Patients already receiving PFS will remain on PFS’s. LPCH has undertaken various investigations of our current active patient cohort receiving Orencia medication in collaboration with the manufacturer and clinical teams. The following patients will be prioritised to receive the pre-filled syringe: 

  • Paediatric patients 
  • Patients over the age of 88 
  • Patients in remote locations where nursing is not easily accessible. 
  • Patients with a diagnosis of Morphea

Can your compounding unit support making abatacept and supplying to us as ‘ready-made IV infusion bags’?

No. The only treatments we can offer given the sort time periods are only as per the recent communication – a prefilled syringe or the Orencia infusion.

How do we procure stock of the IV vials for use in hospital?

This should be following your standard internal procurement processes.

If we arrange a clinic in the hospital for several patients to attend, could one of your nurses attend the hospital to support the administration rather than visit patients in their own home?

At LPCH, we offer a convenient homecare service where a registered nurse visits patients at their homes to administer IV infusions on their treatment due dates. To provide hospital-based care would involve a lengthy administrative process to obtain honorary contracts. However, please note that altering a patient’s treatment schedule to align with a clinic date may have implications for adverse event reporting.

Will you be contacting patients to confirm the date the infusion needs to start? Some patients may have extra stock, or be spreading out dosing frequency to conserve supplies. The next date of delivery wouldn’t be the date of infusion.

All patients will receive a call from our Nursing Scheduler, who will ascertain stock levels and book in their first IV Nursing appointment.

Will you be providing CEF forms after each infusion, so we know when they start?

During each IV infusion, the nurse will complete a patient visit form and submit to the referrer via email. This will include details of the visit, any AE’s and the next infusion date.

Any Nursing blackspots – Can you confirm that more rural Trusts will not be struggling for resource?

We are in partnership with a nursing agency to support our customers with ensuring all patients are offered an IV Abatacept visit. Through this collaboration, we haven’t highlighted any post code we are unable to service.

Will the patients who are already on PFS (but do not currently meet the criteria for Morphea) be remaining on this treatment?

All patient currently receiving PFS will remain with PFS during the stock shortage.

Any patients who are switched to PFS and are unable to inject the PFS due to dexterity issues will they receive ongoing nursing?

This will be reviewed on a case-by-case basis. We have capacity to support in most postcodes.

Do you have any data on incidence of hypersensitivity reactions with abatacept?

Are prescriptions going to go through all the normal checks when it arrives at Lloyds?

The prescription will be screened by one of our Pharmacists at LPCH.

For those who are being switched to IV infusion the Trust will supply new prescriptions as there are several variables in play compared to the prescriptions. Not a question but more an assurance for the trust?

Yes, for movement to IV infusion we would require new prescriptions.

While dedicated nursing is being directed at the Orencia® IV infusion, will this affect face-to-face training opportunities for your other services in Wales?

No Orencia is being supported by additional resource.

Delivery frequency for all subcutaneous device patients prescribed Orencia® from now until the shortage is over?

Delivery will be every 28 days.

Please can you tell me if any of our patients will be continuing on prefilled pens with their current prescriptions / stock availability?

Patient level data has been sent to your team. This list includes details of patients on the various Orencia preparations and recommendations for patients to be switched from PFP to IV infusion excluding the below criteria as advised by BMS and DoH: 

• Patients with the diagnosis of ‘Morphea’  

• Paediatric patients  

• Patients over the age of 88  

Should there be clinical grounds for patients not to receive the IV infusion of Orencia, please inform us of any changes by the 3rd of June to enable us to enact the process to ensure patients are treatment on their due dates. 

Which patients will be identified for a switch to prefilled syringes?

Patient level data has been sent to your team. This list includes details of patients on the various Orencia preparations and recommendations for patients to be switched from PFP to IV infusion excluding the below criteria as advised by BMS and DoH: 

• Patients with the diagnosis of ‘Morphea’  

• Paediatric patients  

• Patients over the age of 88  

Should there be clinical grounds for patients not to receive the IV infusion of Orencia, please inform us of any changes by the 3rd of June to enable us to enact the process to ensure patients are treatment on their due dates. 

Please can you tell me which patients may be identified for a switch to IV?

Patient level data has been sent to your team. This list includes details of patients on the various Orencia preparations and recommendations for patients to be switched from PFP to IV infusion excluding the below criteria as advised by BMS and DoH: 

• Patients with the diagnosis of ‘Morphea’  

• Paediatric patients  

• Patients over the age of 88  

Should there be clinical grounds for patients not to receive the IV infusion of Orencia, please inform us of any changes by the 3rd of June to enable us to enact the process to ensure patients are treatment on their due dates. 

Please can you tell me how this will be managed/plan in place to support the switch in terms of prescription requests/training/nurse visits and patient safety?

Plan:

Patient Communication: 

• Patients will be informed of the switch to the alternative preparation.

Prescriptions: 

• Prescriptions should include supply at least 3 infusions. This will not impact deliveries, as it the treatment will still be dispensed month by month.  

• LPCH will provide pre-populated prescription to each trust for patients switching to IV infusion. 

• For patients switching to pre-filled syringes, LPCH can annotate the current Clickjet prescriptions to amend them to PFS. 

Nursing Capacity and IV Infusion:  

• Patients eligible to receive the PFS formulation will be assessed remotely for self-injection training. For those who decline or are not suitable, a face-to-face nurse visit will be arranged.  

• LPCH has extensive experience in providing and administering intravenous infusions, including systemic anti-cancer treatments and blood products. A full risk assessment has been completed for Abatacept, and all nurses are BLS and anaphylaxis trained, carrying the required emergency medications.  

• LPCH is collaborating with an external nursing agency to provide IV Orencia infusions at home. Agency nurses will undergo specific Orencia training to maintain patient safety. Patients may be visited by either an LPCH nurse or an agency nurse during this time. The Nurse visit will include a 30 min pre and 30 min post observation period and all nurses carry a full anaphylactic kit and are trained in emergency care.  

• Patients will be visited on their due date to receive the IV infusion.  An explanation of the procedure and risk of hypersensitivity/anaphylaxis explained to the patient so as part of the consenting process.  

We would like to bring all our patients to a hospital clinic once a month and the LPCH nursing staff support this. This would save visiting each patient at home, rather have the patients attend a hospital clinic and the LPCH nurse carry out the infusion there instead of in the home. Details on this is key to our decision-making process. Are you able to consider this as an option and provide details of the support you COULD offer if this was an option?

At LPCH, we offer a convenient homecare service where a registered nurse visits patients at their homes to administer IV infusions on their treatment due dates. To provide hospital-based care would involve a lengthy administrative process to obtain honorary contracts. However, please note that altering a patient’s treatment schedule to align with a clinic date may have implications for adverse event reporting.

When this was previously completed for the subcutaneous devices, their home environment may have looked vastly different to how it is today, so who is now responsible for that, in order that both the patients and nurses are safe?

A home risk assessment will be completed by the nurse on arrival. Any concerns will be reported back to the referral hospital.

Can I please have a price for the compounded IV infusion of Orencia®, both on a named patient basis and as a batch?

We are not compounding the IV Orencia due to very short stability, it will be made up at the bedside.

What time frame after the SC dose is the IV given?

1 week after last SC Injection

Will Lloyds be calculating the date of their first infusion based on the last date of the s/c injection?

During the initial call from our scheduling team, we will ascertain the remaining stock level and the date of their finial PFP injection. We will book their nursing visit for the following week and ensure the delivery is align for this date.

What the offer is for supporting the administration of Orencia® IV infusion for most patients in our region, and which patient cohort this would apply to?

All patients who currently receive the PFP Orencia from LPCH will be offered the IV administration service for the duration of the PFP shortage. However, any patient 88 years or over, has a diagnosis of Morphea or a Paediatric patient, they will receive a PFS for the duration of the PFP shortage. If the PFS patients haven’t used this device in the past, they will be offered training via our Remote Nurse Training Team.

The medicines alert and official comms from LPCH states that we are allowed to move 15% of our PFP patients on to PFS. Is this number 15% additional to our current patients on syringes or is it limited depending on how many we already have on syringes?

LPCH has undertaken various investigations of our current active patient cohort receiving Orencia medication in collaboration with the manufacturer and clinical teams. The following patients will be prioritised to receive the pre-filled syringe: 

  • Paediatric patients 
  • Patients over the age of 88 
  • Patients in remote locations where nursing is not easily accessible. 
  • Patients with a diagnosis of Morphea

Will patients continue to receive their PENs as usual? Not sure if you needed a new prescription?

All deliveries booked until the 12th of June will receive their dispensed 4 x PFP order. 

All patients that are due to receive a delivery following the  12th June will receive a call to amend that delivery for IV Abatacept.

Where do we send the prescriptions?

Are Lloyds willing to annotate prescriptions with the required changes?

If the patient still has a valid prescription, and the change is simply switching from pens to syringes, we can annotate the prescription to reflect subsequent deliveries.  However, if the patient is being moved to IV infusion, we will need a new prescription.