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REMEDY : BNSSG referral pathways & Joint Formulary

COVID Medicine Delivery Unit (CMDU) Service

Checked: 13-06-2022 by vicky.ryan Next Review: 12-06-2023

Overview

Treatments are available for those the NHS considers at highest risk of developing severe COVID-19. 

The test to treatment pathway for the CMDU service will now be based primarily on lateral flow device (LFD) tests, supplied by UKSHA to the highest-risk patients which should be used if an individual eligible for COVID treatments experiences COVID symptoms.

Digitally identifiable, eligible patients will receive a letter from NHS England and NHS Improvement to inform them of the change and remind them about treatments with an initial supply of 7 LFD tests in the post.

Patients who have not been identified digitally or captured on national datasets, may be written to separately by their consultant. The national letter below may be utilised.

Anyone who does not receive their test kit, or needs further test kits, should order them via  https://www.gov.uk/order-coronavirus-rapid-lateral-flow-tests or by calling 119. 

It remains essential that patients report their test results (negative or positive) via  www.gov.uk/report-covid19-result  or 119 to assist in digital identification, timely access to treatment and wider surveillance. Results of privately bought tests cannot be registered.

Detailed information for patients can be found here www.nhs.uk/CoronavirusTreatments 

All relevant documentation can be found here CAS-ViewAlert (mhra.gov.uk)

WHAT are they?

Neutralising Monoclonal Antibodies (nMABs)

nMABS are synthetic monoclonal antibodies that bind to the spike protein of the Covid virus, which prevents entry into the host cell and replication.

The nMAB which will be in use:

  • Xevudy (sotrovimab) - symptom onset within 5 days 1stline option (along with Paxlovid -see below)

Antiviral

Antiviral medications inhibit viral replication and prevent progression of infection.

  • Paxlovid (PF-07321332: nirmatrelvir + ritonavir) = 1st line option(along with nMAB above) (symptom onset within 5 days)
  • Remdesivir 2nd line antiviral (symptom onset within 7 days)
  • Molnupiravir 3rd line antiviral (symptom onset within 5 days)

WHERE will they be used?

A CMDU Service has been set up in two GP practices within BNSSG. A clinical assessment team within these GP practices will screen and review patients for their suitability for specialist COVID treatments. These two practices also have an Infusion Unit where they can administer the nMAB via an intravenous infusion for the treatment of COVID-19 if most appropriate choice for the patient.

With the exception of the two GP practices that have an established CMDU other GP practices should not issue a prescription for antivirals and currently the antivirals are only available from hospital pharmacies or through a national trial.

Children aged 12-17 years will continue to receive their infusion at the Bristol Children’s hospital and will continue to be clinically assessed and medication prescribed by Clinical Assessment Team within UHBW only.

Eligibility

Patients will be identified as high risk at the point of a positive Lateral Flow or PCR test and be sent an email and/or SMS text to inform them of this.

If they are eligible for treatment, the designated CMDU GP practice will arrange for the patient to come in for the infusion, or a course of antivirals will be sent to the patient.

Patient who are assessed as not eligible will be informed of this by the CMDU triage service and offered remote monitoring via Oximetry@home.

Eligibility criteria

Non-hospitalised patients are eligible if:

  • Lateral Flow or PCR positive covid test result (registered via gov.uk or NHS 119)
  • Symptomatic AND onset of symptoms of COVID-19 within last 5 to 7 days and showing no signs of clinical recovery.
  • AND a member of a highest risk group (see below).

Exclusion criteria

Patients are not eligible if they meet any of:

  • Require hospitalisation or a new need for supplemental oxygen.
  • Children <40kg
  • Children <12 years of age
  • Known hypersensitivity reaction to the active substance or any of the excipients

Interactions

Further detail on interactions for nMABs or antivirals with other medication(s) can be found in the individual SPC.

Further information can also be found on the University of Liverpool COVID-19 drug interaction checker  https://www.covid19-druginteractions.org/checker

Eligible conditions (Highest risk group)

The published policy has been updated, effective from 13 June 2022, to link to the published report of the Independent Advisory Group commissioned by the Department of Health and Social Care (DHSC) to advise on the groups of patients most likely to be at highest risk of deterioration, hospitalisation or death from a COVID infection

Clinicians are asked to note that figure 1 of the report refers to adults (aged 18 years and over) and figure 2 refers to children (aged 12-17 years).

Please refer to this report to check eligible conditions.

Referral

You may come across some high-risk patients who have slipped through the net, or if the local CMDU has not contacted the patient within 24 hours of receipt of the result, they will be asked to contact either the GP practice or NHS 111 or specialist hospital clinician. You can refer to the Covid Medicines Delivery Unit (CMDU) via the routes below:

The CMDU service referral form has now been added to EMIS. Please send via eRS or email as below.  A Word version of the referral form is also available.

For the minority of clinicians unable to refer patients via the EMIS referral form e.g. specialist hospital clinicians please use the Word version or email as detailed below.

Via e-RS

Infectious diseases - BNSSG Covid-19 (nMABS) Delivery Unit (CMDU). Send these referrals direct and not via the Referral Service

  • Send with the date of the most recent positive Lateral Flow or PCR test please remind patient to register lateral flow test via www.gov.uk/report-covid19-result or NHS 119
  • Date of symptoms start (if known)
  • List of all patient medications/allergies
  • Include medical condition making patient eligible for CMDU
  • Make sure patient contact details are included (a telephone number is essential)
  • Hospital and ward if in Mental Health hospital

Via email

Contact sirona.bnssg.covidvw@nhs.net Subject: Referral for BNSSG Covid-19 CMDU  Include the patient’s:

  • Full name
  • NHS number
  • Date of Birth
  • Address including post code
  • GP practice
  • Date of most recent positive Lateral Flow or PCR test please remind patient to register lateral flow test via www.gov.uk/report-covid19-result or NHS 119
  • Include medical condition making patient eligible for CMDU
  • List of all patient medications/allergies
  • Date of symptoms start (if known)
  • Make sure patient contact details are included (a telephone number is essential)
  • Hospital and ward if in Mental Health hospital

IMPORTANT: State in the subject line “Referral for BNSSG Covid-19 CMDU” (this email also accepts referrals for pulse oximetry virtual ward so essential that it is clear that referral is for CMDU please)

Weekend Referrals

NHS111, Out of Hours and colleagues working within BNSSG

Adults and Children (aged 12-17 years old)

Please note over the weekend period the CMDU service (clinical assessment and eligibility screening) within primary care is available on a Saturday morning only. The service is then reinstated on a Monday morning with additional workforce. Therefore, patients referred on a Saturday afternoon, Sunday morning or afternoon are all screened on a Monday morning. Please can you advise patients that may present over the weekend to expect a phone call from a clinician on the Monday and to contact their regular GP if they haven’t heard from a clinician by the Monday afternoon. 

 

Mental Capacity

A pool of clinicians across BNSSG support the service by checking those referred are eligible (according to centrally published criteria) and discussing treatment options with the patient. 

In rare cases where patients lack capacity it may be necessary for the service to seek help from the patient’s GP. The time critical nature of the treatment means decisions need to be made on the day or within 24 hours for the majority of cases. The CMDU clinician will contact the practice – initially by phone and then by sending details to the email address the practice provides – with details of the eligibility criteria and treatments available. They will ask the GP whether the patient meets the criteria and if so – on balance – whether treatment is likely to be in the patients bests interest. For example, would traveling to hospital for a day case infusion be unduly distressing, would they accept an IV cannula, would they take a large capsule twice a day.

Screeners will make every effort to make this decision independently and the patient’s GPs will be asked to support only in exceptional circumstances.

Additional information

What are the side effects? 

For a list of side effects please refer to individual summary of product characteristics below

Effectiveness of the nMABs or antivirals

Drug

 

Hospital admission rate – control

Hospital admission rate – treatment

Number Needed to Treat

Relative risk reduction

Sotrovimab1

6%

1.0%

20

 85%

Molnupiravir2

9.7%

6.8%

35

 30%

Paxlovid3

7%

0.8%

16

89%

 

Summaries of Product Characteristics:

  1. SPC/Xevudy
  2. SPC/Lagevrio
  3. SPC/Paxlovid  Patient information leaflet Paxlovid 

National Letter sent to high-risk patients for preparation

Email/SMS/text sent to high-risk patients following positive COVID test from Monday 20 Dec 2021

Learning events

It is important that any near miss or incident is reported on Datix

As these medications are MHRA black triangle drugs, all adverse reactions occurring in individuals of any age after administration should be reported to the MHRA using the specific Coronavirus Yellow Card Scheme. https://coronavirus-yellowcard.mhra.gov.uk/

Panoramic Clinical Study

The Panoramic study is looking at the use of oral anti-viral treatment for patients with recently acquired COVID infection. Please see the attached Information on Panoramic Study looking at oral anti-viral treatment for COVID patients for further details and how patients can sign up.