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

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.

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.

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

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

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. 

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.

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

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.

A variation letter is suitable. 

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.

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.

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.

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. 

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. 

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.

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. 

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

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

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

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

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.

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.

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. 

Due to expire week commencing 24th June 2024.

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

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.

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.

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

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.

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.

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

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.

Both, LPCH and agency nurses.

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.

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

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.

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

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

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.

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.

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.  

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.

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

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.

This should be following your standard internal procurement processes.

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.

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

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.

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.

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

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

Please refer to the SMPC here: https://www.medicines.org.uk/emc/product/334/smpc#gref

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

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

No Orencia is being supported by additional resource.

Delivery will be every 28 days.

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. 

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. 

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. 

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.  

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.

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

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

1 week after last SC 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.

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.

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

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

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

lpch.prescriptionsmgmt@nhs.net

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.