Important: Therapy notes
MHRA advice: CDK4/6 inhibitors (abemaciclib, palbociclib, ribociclib): reports of interstitial lung disease and pneumonitis, including severe cases (June 2021) (www.gov.uk).
Welcome to the Right Decision Service (RDS) newsletter for April 2024.
Tactuum has been working hard to address the issues experienced during the last week. They have identified a series of three mitigation measures and put the first of these in place on Friday 3rd May. If this does not resolve the problems, the second mitigation will be actioned, and then the third if necessary.
Please keep a lookout for any slowing down of the system or getting locked out. Please email myself, mbuchner@tactuum.com and onivarova@tactuum.com if you experience any problems, and also please raise an urgent support ticket via the Support Portal.
Thank you for your patience and understanding while we achieve a full resolution.
A rotating carousel presenting some of the key RDS tools and capabilities, and an editable slideset, are now available in the Resources for RDS providers section of the Learning and Support toolkit.
The redesign of RDS Search and Browse is still on-track for delivery by mid-June 2024. We then plan to have a 3-week user acceptance testing phase before release to live. All editors and toolkit owners on this mailing list will be invited to participate in the UAT.
The archiving and version control functionality is also progressing well and we will advise on timescales for user acceptance testing shortly.
Tactuum is also progressing with the deep linking to individual toolkits within the mobile RDS app. There are several unknowns around the time and effort required for this work, which will only become clear as the work progresses. So we need to be careful to protect budget for this purpose.
These have all been compiled and effort estimated. Once the redesign work is complete, these will be prioritised in line with the remaining budget. We expect this to take place around late June.
Many thanks to those of you completed the value and impact survey we distributed in February. Here are some key findings from the 65 responses we received.
Figure 1: Impact of RDS on direct delivery of care
Key figures
Figure 2 shows RDS impact to date on delivery of health and care services
Key figures
These data show how RDS is already contributing to NHS reform priorities and supporting delivery of more sustainable care.
Saving time and money
Quality assurance and governance
Service innovation and workforce development
A few examples of toolkits published to live in the last month:
Some of the toolkits the RDS team is currently working on:
Please contact his.decisionsupport@nhs.scot if you would like to learn more about a toolkit. The RDS team will put you in touch with the relevant toolkit lead.
Thanks to all of you who have responded to the retrospective quality audit survey and to the follow up questions. We still have some following up to do, and to work with owners of a further 23 toolkits to complete responses. An interim report is being presented to the HIS Quality and Performance Committee.
Eight clinical services and two public library services are undertaking tests of change to implement the Being a partner in my care app. This app aims to support patients and the public to become active participants in Realistic Medicine. It has a strong focus on personalised, person-centred care and a library of shared decision aids, as well as simple explanations and videoclips to help the public to understand the aims of Realistic Medicine. The tests of change will inform guidance and an implementation model around wider adoption and spread of the app.
With kind regards
Right Decision Service team
Healthcare Improvement Scotland
25/04/24 - Olaparib tablets 100mg. 150mg SMC2617 indication added.
25/04/24 - Daratumumab concentrate for solution for infusion 10mg/ml - additional indication added: in place of SMC advice 2302: In combination with bortezomib, lenalidomide and dexamethasone (Dara-VRD), for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
25/04/24 - Talazoparib capsules 0.25mg, 1mg SMC2607 added.
25/04/24 - Loncastuximab powder for concentrate for solution for infusion 10mg SMC2609 added.
25/04/24 - Ivosidenib tablets 250mg SMC2615 added.
30/04/24 - Bevacizumab corrected SMC indication from 878/13 to 806/12.
MHRA advice: CDK4/6 inhibitors (abemaciclib, palbociclib, ribociclib): reports of interstitial lung disease and pneumonitis, including severe cases (June 2021) (www.gov.uk).
Tabets 100mg (hospital use only)
See SMC advice 2346, 2347 and 2348.
Homecare is the preferred option - contact nhsh.homecare@nhs.scot
Tablets 20mg, 30mg, 40mg, 50mg (hospital use only)
See SMC advice 920/13.
MHRA advice: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection (July 2020) (www.gov.uk).
Concentrate for solution for infusion 25mg/mL (hospital use only)
See SMC advice 878/13.
Capsules 150mg (hospital use only)
See SMC advice 2012.
Injection 50mg/mL unlicensed (hospital use only)
Concentrate for solution for infusion 1mg/ml (hospital use only)
See SMC advice 2181.
Tablets film-coated 20mg, 40mg (hospital use only)
See SMC advice 2482.
MHRA advice: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection (July 2020) (www.gov.uk).
Film-coated tablets 40mg (hospital use only)
See SMC advice 2587.
Also for selected patients with indolent (FCC, MCL, MZL, SLL, LPC) non-Hodgkin’s lymphoma.
MHRA advice: Bendamustine (Levact): increased risk of non-melanoma skin cancer and progressive multifocal encephalopathy (PML) (March 2021) (www.gov.uk).
MHRA advice: Bendamustine (Levact): increased mortality observed in recent clinical studies in off-label use; monitor for opportunistic infections, hepatitis B reactivation (July 2017) (www.gov.uk).
Powder for concentrate for solution for infusion 25mg, 100mg (hospital use only)
See SMC advice 694/11.
Powder for solution for injection 15,000 units (hospital use only) unlicensed
Tablets 100mg, 500mg (hospital use only)
See SMC advice 910/13.
MHRA advice: Cabazitaxel (Jevetana): risk of medication error resulting in overdose (December 2014) (www.gov.uk).
Concentrate for solution for infusion 40mg/mL (hospital use only)
See SMC advice 735/11.
MHRA advice: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection (July 2020) (www.gov.uk).
Tablets 15mg (hospital use only)
MHRA advice: 5-fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity (October 2020) (www.gov.uk).
Powder and solvent for solution for injection 10mg (hospital use only)
See SMC advice 2266.
Concentrate for solution for infusion 10mg/mL (hospital use only)
See NICE guidance CG121.
MHRA advice: Carfilzomib (Kyprolis): risk of reactivation of hepatitis B virus (November 2019) (www.gov.uk).
MHRA advice: Carfilzomib (Kyprolis): reminder of risk of potentially fatal cardiac events (August 2019) (www.gov.uk).
Capsules 150mg (hospital use only)
See SMC advice 1097/15.
Concentrate for solution for infusion 1mg/mL (hospital use only)
See NICE guidance NG122.
MHRA advice: Cladribine (Mavenclad): new advice to minimise risk of serious liver injury (March 2022) (www.gov.uk).
Risk minimisation materials
Solution for subcutaneous injection 2mg/mL (hospital use only)
See SMC advice 537/09.
MHRA advice: Cirzotinib (Xalkori): risk of cardiac failure (November 2015) (www.gov.uk).
Risk minimisation materials
MHRA advice: Liposomal and lipid-complex formulations: name change to reduce medication errors (July 2020) (www.gov.uk).
Intrathecal injection 20mg/mL (hospital use only)
Injection 100mg/mL (hospital use only)
Tablets 15mg, 30mg and 45mg (hospital use only)
45mg once daily until disease progression or toxicity.
See SMC advice 2184.
Powder for solution for injection 500 micrograms (hospital use only)
MHRA advice: Daratumumab (Darzalex): risk of reactivation of hepatitis B virus (August 2019) (www.gov.uk).
Risk minimisation materials
Concentrate for solution for infusion 20mg/mL (hospital use only)
See SMC advice 1205/17 and 2302.
In place of SMC advice 2302: In combination with bortezomib, lenalidomide and dexamethasone (Dara-VRD), for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
Solution for injection 120mg/mL (15mL) (hospital use only)
See SMC advice 2447.
Solution for injection 1800mg/15ml (hospital use only)
See SMC advice 2536.
Concentrate for solution for infusion 100mg/5ml and 400mg/20ml (hospital use only)
See SMC advice 2536.
Tablets 20mg, 50mg, 80mg, 100mg, 140mg (hospital use only)
See SMC advice 370/07.
MHRA advice: Liposomal and lipid-complex formulations: name change to reduce medication errors (July 2020) (www.gov.uk).
Powder for solution for infusion 20mg (hospital use only)
Injection 50mg/mL (hospital use only)
MHRA advice: Liposomal and lipid-complex formulations: name change to reduce medication errors. (July 2020) (www.gov.uk).
Solution for injection 2mg/mL (hospital use only)
Solution for injection 0·44mg/mL (hospital use only)
See SMC advice 1065/15.
Tablets 100mg, 150mg (hospital use only)
See SMC advice 220/05.
Capsules 100mg (hospital use only)
See SMC advice 2462.
Tablets 10mg (hospital use only)
MHRA advice: 5-fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity (October 2020) (www.gov.uk).
Solution for infusion 25mg/mL, 50mg/mL (hospital use only)
Cream 5% (Efudix)
Tablets, film coated 100mg, 150mg (hospital use only)
As per SMC advice 2300.
Solution for injection 250mg (specialist recommendation or initiation only)
For use as monotherapy see SMC advice 114/04.
For use with palbociclib (SMC advice 2149) see fulvestrant shared care protocol.
Powder for concentrate for solution for infusion 5mg (hospital use only)
See SMC advice 2089.
Tablets film-coated 40mg (hospital use only)
See SMC advice 2252.
Capsules 500mg (hospital use only)
Oral solution 100mg/mL (hospital use only)
See SMC advice 2271.
MHRA advice: Ibrutinib (Imbruvica) reports of ventricular tachyarrhythmia; risk of hepatitis B reactivation and or opportunistic infections (August 2017) (www.gov.uk).
Capsules 140mg (hospital use only)
See SMC advice 1150/16, 1151/16.
Homecare is the preferred option - contact nhsh.homecare@nhs.scot
MHRA advice: Idelalisib (Zydelig): updated indications and advice on minimising the risk of infection (September 2016) (www.gov.uk).
MHRA advice: Liposomal and lipid-complex formulations: name change to reduce medication errors (July 2020) (www.gov.uk).
Concentrate for solution for infusion 20mg/mL (hospital use only)
See NICE guidance CG131.
Concentrate for solution for infusion 20mg/ml (hospital use only)
See SMC advice 2303.
Tablets 250mg (Restricted: Hospital use only)
See SMC advice 2615.
MHRA advice: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection (July 2020) (www.gov.uk).
Powder for concentrate for solution for infusion 44mg/100mg (hospital use only)
See SMC advice 2130.
Powder for concentrate for solution for infusion 10mg (Restricted: hospital use only)
See SMC advice 2609.
Tablets 50mg (hospital use only)
Oral suspension 100mg/mL (hospital use only)
See SMC advice 798/12.
MHRA advice: Methotrexate: advise patients to take precautions in the sun to avoid photosensitivity reactions (August 2023) (www.gov.uk).
MHRA advice: Methotrexate once-weekly for autoimmune diseases: new measures to reduce risk of fatal overdose due to inadvertent daily instead of weekly dosing (September 2020) (www.gov.uk).
Risk minimisation materials
Oral solution 10mg/5mL (hospital use only)
Solution for injection 25mg/mL, 100mg/mL (hospital use only)
Intrathecal injection 50mg/2mL (hospital use only)
Tablets 50mg (hospital use only)
See SMC advice 1330/18.
Film-coated tablets 40mg (hospital use only)
See SMC advice 2251.
MHRA advice: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection (July 2020) (www.gov.uk).
Capsules (Vargetef®) 100mg, 150mg (hospital use only)
See SMC advice 1027/15.
MHRA advice: Niraparib (Zejula): reports of severe hypertension and posterior reversible encephalopathy syndrome (PRES), particularly in early treatment (October 2020) (www.gov.uk).
Concentrate for solution for infusion 25mg/mL (hospital use only)
See SMC advice 1008/14.
Capsules 50mg (hospital use only)
See SMC advice 1047/15.
MHRA advice: Paclitaxel formulations (conventional and nab-paclitaxel): caution required due to potential for medication error (January 2022) (www.gov.uk).
MHRA advice: CDK4/6 inhibitors (abemaciclib, palbociclib, ribociclib): reports of interstitial lung disease and pneumonitis, including severe cases (June 2021) (www.gov.uk).
Concentrate for intravenous infusion 20mg/mL (hospital use only)
See NICE MTA 439.
Capsules 10mg, 15mg, 20mg (hospital use only)
See SMC advice 1122/16.
MHRA advice: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection (July 2020) (www.gov.uk).
Tablets 200mg, 400mg (hospital use only)
See SMC advice 676/11.
Tablets 4·5mg, 9mg, and 13·5mg (hospital use only)
See SMC advice 2399.
Solution for injection (Phesgo) 600mg/600mg, 1200mg/600mg (hospital use only)
See SMC advice 2364.
MHRA advice: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection (July 2020) (www.gov.uk).
MHRA advice: Ponatinib (Iclusig): reports of posterior reversible encephalopathy syndrome (October 2018) (www.gov.uk).
MHRA advice: Ponatinib (Iclusig): risk of vascular occlusive events - updated advice on possible dose reduction (April 2017) (www.gov.uk).
Tablets 15mg, 45mg (hospital use only)
See SMC advice 1032/15.
Hard capsules 100mg (hospital use only)
See SMC advice 2496.
MHRA advice: Radium-223 dichloride (Xofigo): new restrictions on use due to increased risk of fracture and trend for increased mortality seen in clinical trial (September 2018) (www.gov.uk).
Solution for injection 1,000kBq/mL (hospital use only)
See SMC advice 1077/15.
Powder for solution for infusion 2mg (hospital use only)
See NICE guidance CG131.
MHRA advice: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection (July 2020) (www.gov.uk).
MHRA advice: CDK4/6 inhibitors (abemaciclib, palbociclib, ribociclib): reports of interstitial lung disease and pneumonitis, including severe cases (June 2021) (www.gov.uk).
MHRA advice: Rucaparib (Rubraca): withdrawal of third-line treatment indication (September 2022) (www.gov.uk).
Tablets 200mg, 250mg, 300mg (hospital use only)
See SMC advice 2224.
Powder for concentrate for solution for infusion 180mg (hospital use only)
See SMC advice 2446.
MHRA advice: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection (July 2020) (www.gov.uk).
Film-coated tablets 120mg (hospital use only)
See SMC advice 2443.
MHRA advice: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection (July 2020) (www.gov.uk).
Capsules 0.25mg, 1mg (Restricted: hospital use only)
See SMC advice 2607.
MHRA advice: 5-fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity (October 2020) (www.gov.uk).
Capsules (Teysuno®) 15mg/4·35mg/11·8mg, 20mg/5·8mg/15·8mg (hospital use only)
See SMC advice 802/12.
MHRA advice: Temozolomide: risk of hepatic injury, including fatal hepatic failure - updated warnings and monitoring guidance (December 2014) (www.gov.uk).
Film-coated tablets 225mg (hospital use only)
See SMC advice 2535.
MHRA advice: Systemically administered VEGF pathway inhibitors: risk of aneurysm and artery dissection (July 2020) (www.gov.uk).
Hard capsules 890 micrograms and 1,340 micrograms (hospital use only)
See SMC advice 1335/18.
Powder for concentrate for solution for infusion 1mg (hospital use only)
See NICE guidance TA389.
Powder for concentrate for solution for infusion 0·25mg, 1mg (hospital use only)
See SMC advice 2283.
MHRA advice: Trametinib (Mekinist): risk of gastrointestinal perforation and colitis (March 2016) (www.gov.uk).
Tablets 50mg, 150mg (hospital use only)
See SMC advice 2398.
MHRA advice: Vemurafenib (Zelboraf): risk of potentiation of radiation toxicity (November 2015) (www.gov.uk).
Tablets 240mg (hospital use only)
See SMC advice 792/12.
Capsules 20mg, 30mg (hospital use only)
Concentrate for solution for infusion 10mg/mL (hospital use only)
See NICE guidance CG81.