National Medication Safety Officer Network - PowerPoint Presentation

1. National Medication Safety Officer NetworkWelcome to the monthly web meeting Wednesday 26th April 2023Web meeting processWelcome to our monthly meeting using MS TeamsPlease use the chat box to comment, share your experiences and ask questions.The meeting will be recorded & available on the MSO Workspace on FutureNHS along with the slides and any additional resources.Email: lnwh-tr.sps-mso@nhs.net for an invite to the MSO FutureNHS Workspace Medication Safety Officer - FutureNHS Collaboration Platform Make sure the contact details for your organisation are up to date. This should be a generic MSO email address.Email: safety.alerts@mhra.gov.uk with any changes in MSO or email addresses

2. Agenda 26th April 2023DetailPresenterTimeNetwork UpdateMSO Network UpdateEmma Kirk Specialist Pharmacist – Lead Medication SafetySPS6 minsSharing the learningSystems learning - SulphasalazinePolly CranmerMSO, Gateshead Health NHS Foundation Trust15 mins National updateNHSEReview and response to new and under recognised issuesSarah JenningsPatient Safety Clinical Lead (Medical Devices) NHS England10 minsNational UpdateValproate SafetyTony JamiesonPatient Safety and Clinical Improvement LeadMedicines Safety Improvement ProgrammeNHS England15 mins Medication Safety UpdateA summary of recent safe medication practice research, reports and publicationsChristine RandallLead Pharmacist for Dental Medicines Information and PharmacovigilanceSPS Medicines Advice Service 12 minsClosing remarksCloseEmma KirkSpecialist Pharmacist – Lead Medication Safety, SPS2 mins

3. Ensure contact details are correct for the databaseParticularly if you were in a CCGSpecific MSO feedback on MSATS webinarSlido #2480291 passcode: b1kuhv MDSO/MSO Conference – Event recording now available to accesshttps://youtu.be/g-7FJ00CsRENetwork Update

4. Future NHS Platform – MSO Workspace – Discussion ForumNetwork Update

5. Joint MSO/EPMA webinar – Wednesday 17th May 1-2pmRegister hereRPS Error reporting standards Consultation open Give your views hereNetwork Update

6. MSc Research Study: Medication Error from Verbal CommunicationMSO Network SurveyThe study aims to evaluate medication error from verbal communication between healthcare professionals. You are invited to participate in this study in your capacity as a Medication Safety Officer. You will be invited to: 1) Complete an online survey that is expected to take no more than 5 minutes to complete. Invitation and survey link will be sent via email. 2) At the end of the survey, offered an opportunity to participate in a follow-up interview, which will take no longer than 45 minutes. Interviews will be held online at a mutually agreed time via MS Teams. Participation in this study is completely voluntary. The identity of all participants will remain confidential. If you have any questions about this study or your participation, please contact me at Sharon.howarth21@imperial.ac.uk or Sharon.howarth3@nhs.netThank you in advance for your consideration and participation.Sharon Howarth (GPhC 2041375)

7. Polly Cranmer26.4.23Systems learningSulfasalazine

8. Patient caseThe learning and how this was sharedBarriers faced and solutionsExperience of use of new PSII report templateReflections: What would we do differently next time?Content

9. Patient with COPD and rheumatoid arthritis (RA) – previously treated with methotrexateRecurrence of RA symptoms – review by rheumatology teamDecision with patient to trial sulfasalazineBaseline blood tests normalInitiation followed protocol – including shared care process, therapy audit monitor and follow up, patient counselling (verbal and written). 2 weekly blood tests plannedRepeat blood tests at 2 weeks – normal – shared care initiated10 days later felt unwell (fatigued) and contacted rheumatology teamAdvised to stop for 2 weeks, no blood tests advisedFollow up at 2 weeks – felt better, decision to restart, no blood tests advised but arranged for 2 weeksPatient case – unexpected death during treatment with sulfasalazine

10. 10 days later felt unwell (sore throat, fatigue), patient stopped sulfasalazineAttended GP practice, prescribed antibiotics for tonsillitis, advised to keep planned blood test appointment due at day 14 (4 days later). Sulfasalazine acknowledged as stoppedRepresented at GP practice 3 days later. Ongoing sore throat. Advised to continue antibiotics and keep planned blood test for the following dayPatient cancelled blood test as felt too unwellPatient cancelled planned telephone follow up with rheumatology team – rheumatology nurse was concerned and called patient back to assessRheumatology nurse contacted GP practice to arrange urgent blood test via e-Contact, not arrangedPatient case – unexpected death during treatment with sulfasalazine

11. Following day patient contacted 111 – advised to attend walk in centre – seen and antibiotics changed, acknowledged already stopped sulfasalazine2 days later contacted 111 again – referred to ED – admitted. Diagnosed with neutropenic sepsis and treatment given as per policyPatient sadly died following cardiac arrest 5 days later, August 2022Incident report completed by medical examiner during scrutiny of death. Triggered discussion at safety triangulation group, agreement to declare as SI, FLO’s (family liaison officers) assigned, investigation begun. Coroner involvement.MSO assigned as lead investigator to work across the primary secondary care interfaceDecision to utilise new format for PSII from PSIRF for organisational learning and individual experiencePatient case – unexpected death during treatment with sulfasalazine

12. What was the learning?Learning was identified at three points in care:The initiation phaseInterruption to treatment phaseAcute illness phaseEach learning point triggered a safety recommendation for the system improvement plan.Initiation phaseA new national shared care protocol for the prescribing and monitoring of sulfasalazine was published in June 2022.The therapy audit monitor (TAM) system used to flag overdue blood tests was set to flag at ten days following a missed blood test. Patients would not be sent a reminder letter to book a blood test until at least ten days after the missed appointment.

13. What was the learning?Patients can ‘opt in’ to a text message reminder service to remind the patient when blood tests are due. This is included in the counselling checklist for the rheumatology team to ask for consent. Once consent is gained there is then a required action to update the TAM system to allow the automated message to be triggered. There is no safeguard in place if this is not actioned by the team member.There was an occurrence where an expected system flag on TAM did not occur. When planned blood tests reached 10 days overdue on 4.8.22 the system flag should have generated a reminder task to print an overdue blood test letter. Despite investigation with the digital support team from the system provider we were unable to establish why.The administration of the TAM system is carried out by the TAM clerk. This includes generating letters for patients to inform of missed blood tests. During times of absence this role is not adequately covered. Additional administrators are now available to the rheumatology team but additional training is required to ensure the current standard operating procedures are followed. Use of paper based system (postal letters) can lead to delays in patients receiving communication to book a blood test.

14. What was the learning?Interruption to treatment phaseThere is no local protocol within the rheumatology service to support decision making if patients have an unplanned interruption to treatment within the initiation phase of treatment.Acute illness phaseThe current shared care protocol does not give clear guidance on when additional blood tests are indicated during the initiation phase where the patient has already discontinued therapy. The guidance states that it is not normally necessary to stop treatment with sulfasalazine during treatment with antibiotics but this conflicts with the need for urgent blood tests when a patient presents with a severe sore throat.Sulfasalazine is accepted as having a lower risk of serious side effects than other medicines used in the treatment of rheumatoid arthritis as serious side effects are rare.

15. What was the learning?Only one section of the shared care agreement was visible in the GP digital notes – the section that was signed by the GP practice to accept shared care was visible but the rest of the agreement (including the guidance sections) was not scanned in.A digital system called GP Team net is used as a resource sharing platform for GP practices. The approved and most contemporary shared care guidance for the Trust could not be found within this platform.

16. How did we share the learning?Family via FLO and final reportMedicines governanceRegional Drug and Therapautics Committee – regionally commissioned to undertake review of national protocolsRegional MSO networkICB pharmacy leadsTrust digital leadsLearning library – hosted via sharepoint

17. What barriers did we face? How did we overcome them?BarrierWhat helped?Initial reaction – this is a primary care eventDiscussion at STG, rapid review process, recognition of complexity – we need to know moreMultiple points of care/teams involved, complexityMapping of contact points in conjunction with familyHosted learning team event with all stakeholdersICB structure was evolving at the time, delay in establishing the right people and escalation routesLines of communication via patient safety teamMeeting the families needsFLO’s, TOR, answering complaint alongside investigation report – referenced in reportPrevious negative experience of team member relating to coronial processRecognition of second victim, additional support providedEngagement with GP practice, statement based on assumptions, no process, 3rd party engagement, delay in learningAsking very specific questions in line with TORSharing report template, introducing SEIPS, face to face discussion, use of language

18. Experience of the new PSIRF PSII templateUse of SEIPs – helpful to frame a systems investigation for both family and teams involved – helps to introduce some of the language of patient safetySetting clear terms of referenceFlexibility to include family questionsAligning each learning point specifically to a safety action or recommendation to inform the system improvement plan

19. What would I do differently next time?Utilise after action review template and stakeholder map to support discussion with external teamsNHS England » Patient safety learning response toolkitAcknowledge different services/partners at different points of the PSIRF safety culture journey. Replace ‘reflective account’ documentation with a framework for systems discussionShare the draft report with family before sign off to check for factual inaccuracy and give further opportunity to discuss contentSeek wider support earlier in process – look outwards, challenge own assumptions about the learning, widen lens, be realistic about time frames for engagement

20. Summary of my approach nowWhat are the family or patient needs? Duty of candour? Who is interacting with the family or patient?What is the right format for review here? What is available to me? PSII? After action review? Something else?Who needs to be involved? Widen lens, pharmacy teams exist within complex systemsSet timeframes and expectationsBe prepared for the unexpected. You may have to change courseResist urge to assume learning!

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22. Review and response to potentially new and under recognised medicines safety issuesMedication Safety Officer NetworkSarah JenningsPatient Safety Clinical Lead (Medical Devices) National Patient Safety Team NHS England and ImprovementApril 2023

23. Insulin delivery via pen devices and the impact of appropriate needle selectionA trigger incident (Ref 82952222) was identified during our regular review of reported death and severe harm incidents (August 2022): Patient with Type 1 diabetes developed diabetic ketoacidosis. No precipitating factor identified other than potential incorrect administration of insulin. Nursing staff administer the insulin. The insulin is not available in a vial, therefore a safety pen needle was used. When checking safety needles available on the ward it was found the BD Duo AutoShield Safety needles were mixed in with the other pen needles. All ward areas have been advised that these should not be used due to previous concerns with partial doses being administered. Patient required transfer to critical care.Reported as Severe Harm.MDSO Patient Safety updates from the National PS team April 2023

24. Insulin delivery using insulin pens and safety needlesEU Directive 2010/32/EU Prevention from sharp injuries in the hospital and healthcare sector which was adopted in May 2010DisposableReusableAlways use a new needle for each administration/useInsulin pen needles can have either an active or a passive safety mechanism. Choice impacts method of delivery.MDSO Patient Safety updates from the National PS team April 2023

25. Insulin pen safety needles MDSO Patient Safety updates from the National PS team April 2023

26. Insulin delivery using insulin pen safety needlesWhen dose administered noticed that had not fully fired and not all of the dose was administered . Approximatley five units were not given . team leader informed and GP being informed . CBG monitoring being carried out this pm to check CBG levels staying within range . .Patient was found to have developed DKA as an inpatient despite being prescribed subcutaneous insulins . Clinical suspicion remains that the cause of this was use of auto - cover needles to administer the insulins ; when using normal insulin needles , the patient blood sugar was under much better control .During administration of prescribed dose I moved my hand holding the syringe and as less pressure was applied the safety feature clicked in . When administration checked , needle mark seen at sight of the injection but also insulin observed on the skin . Not able to determine how much insulin had been administered . Patient informed me that she had to attend A&E yesterday evening as her blood glucose levels were very high . Patient reports that the District Nurse that attended at 16:30 to administer the patient insulin , gave it with a new type of needle . Patient reports it was an [name of passive device]needle . Patient says she didn't think the needle was used properly , and that she felt the ' wetness' of the insulin on her skin after the injection suggesting that the full dose hadn't been administered MDSO Patient Safety updates from the National PS team April 2023

27. Shared decision making in selecting appropriate devices for insulin delivery via a pen deviceConsideration when selecting insulin pen needles as to:Who is administering?Level of understanding, access to training, education and competency review?Type of workforce – transient or temporary?Storage – do staff know what they are using?Who may be at risk of a NSI in the environment of use – other HCPs, ancillary staff (domestics, laundry staff), other family members and carers?ResourcesPassive or active delivery devices in diabetes administration? - PharmiWeb.comInjection Technique Matters – Trend DiabetesInjection Technique Matters – Trend Diabetes Learning PlatformFindings being shared with:NAMDET, Diabetes leads at TREND and RCN Diabetes Specialists, Clinical procurement, MSOs and MDSOsMDSO Patient Safety updates from the National PS team April 2023

28. Valproate SafetyApril 2023Tony Jamieson, Patient Safety Specialist and Clinical Improvement LeadVivian De Vittoris, Chief Pharmaceutical Officer Clinical Fellow

29. Population on Valproate: 167,346 peopleValproate Safety – Estimated Figures

30. Valproate Registry at March 2022

31. Variation: Initiation of valproate in 13-54 yearsThe UK has a higher rate of valproate prescribing than many other countries in Europe. For example Denmark has roughly 20% of the UK’s estimated patient years for treatment.-Cumberlege reportValproate Safety

32. Valproate Safety

33. Valproate Safety * proposed by CHM and subject to agreement

34. Informed personalised careShared decision makingOptimised careAcknowledged riskValproate Safety

35. Appreciative InquiryThanks to: Bristol, North Somerset and South Gloucestershire; Cornwall; Somerset; Bath, North East Somerset, Swindon & Wiltshire; Surrey Heartlands; Avon & Wiltshire; Devon; Lancashire & North Cumbria; Greater Manchester; NHS England Clinical LeadershipValproate Safety

36. Findings of the Appreciative InquiryValproate Safety

37. Moving forwardValproate Safety

38. Prepared by Christine RandallSPS MA Pharmacist(Liverpool)Christine.Randall@liverpoolft.nhs.ukSPS Medication Safety Update April 2023Recent critical patient safety alerts, reports, and publications

39. DHSCCOVID-19 Therapeutic Alert (CEM/CMO/2023/001)Publication of NICE Multiple Technology Appraisal (MTA) - Treatment Recommendations for COVID-19Patient Safety Alerts

40. Recent regulator and statutory body activityClass 4 Medicines Defect Information: Ethigen Limited, Briviact 75mg & 100mg film-coated tablets, EL(23)A/13Patient Information Leaflet (PIL) in Briviact 75mg and Briviact 100mg film coated tablets contains incorrect or missing information.Class 4 Medicines Defect Information: Sandoz Limited, Co-amoxiclav 125/31.25mg/5ml, 250/62.5mg/5ml powder for oral suspension, EL (23)A/14Sandoz limited has informed the MHRA that the products mentioned in this notification are not sugar free despite the carton stating ‘sugar free’. The ‘sugar free’ text was added to the carton in December 2008 in error.Company led medicines recall: Spectrum Therapeutics UK, Canopy AKH 22 Dried Cannabis 5g [unlicensed medicine], CLMR (23)A/04The importer and distributor of the above products has informed us of reports that the microbial limit for Total Microbial Aerobic Count (TAMC) has been tested to exceed the predefined limit of 200 CfU/g as per the product specification fixed according to Pharm. Eur. Monograph 5.1.4 (inhalation use).Belzer UW Cold Storage Solution and Belzer MPS UW Machine Perfusion Solution manufactured by Carnamedica (UKRP: Bridge to Life): Contamination of fluid (update to DSI/2023/002), DSI/2023/005Replaces advice in DSI/2023/002, which should no longer be followed. Details an updated list of LOTs associated with defect reports, additional problems identified with the solution, and new actions for healthcare professionals.

41. Recent regulator and statutory body activityDrug Safety Update – April issue published after slides finalised

42. Direct HCP communicationDirect to Healthcare professionals letters (sent Feb 2023)Mylotarg (gemtuzumab ozogamicin) 5mg powder for concentrate for solution for infusion: interim supply from USOnasemnogene abeparvovec (Zolgensma▼): fatal cases of acute liver failureONIVYDE pegylated liposomal 4.3 mg/ml concentrate for dispersion for infusion Interim Supply of Irish packs (common pack for Republic of Ireland and Northern Ireland) to Mitigate Supply DisruptionADAKVEO ▼ (crizanlizumab): Phase III study (CSEG101A2301) shows no superiority of crizanlizumab over placebo

43. Pharmacovigilance Risk Assessment Committee (PRAC)Meeting 11-14th April 2023The Committee did not start or conclude any referral procedures. Ongoing Referrals Topiramate – use in pregnancy and women of childbearing potentialPseudoephedrine – safety review of pseudoephedrine containing medicines

44. SPC changes or Manufacturer RMMRevised SPC: Stivarga (regorafenib) 40 mg film-coated tabletsWarnings on risk of thrombotic microangiopathy (TMA), including thrombotic thrombocytopaenic purpura, which has been reported with use of regorafenib. In patients who develop TMA, SPC advises to discontinue regorafenib and seek prompt treatment.Revised SPC: Mezavant (mesalazine) XL 1200mg, gastro-resistant, prolonged release tabletsPotential to cause red-brown urine discoloration after contact with sodium hypochlorite bleach (e.g. in toilets cleaned with sodium hypochlorite contained in certain bleaches).Revised SPC: Venlafaxine XL 150 mg prolonged-release tablets (Dexcel Pharma)Patients should be advised not to use alcohol, considering its CNS effects and potential of clinical worsening of psychiatric conditions, and potential for adverse interactions with venlafaxine. Overdose with venlafaxine has been reported predominantly with alcohol.Revised SPC: Orkambi 100 mg/125 mg and 150 mg/188 mg (lumacaftor/ ivacaftor) granules in sachetNew table for patients on strong CYP3A inhibitors; revised table to include data on both moderate & severe hepatic impairment; revised method of administration to include more examples of foods & liquids, & info on sweat chloride added to pharmacodynamics section.

45. SPC changes or Manufacturer RMMRevised SPC: Omeprazole preparationsAcute tubulointerstitial nephritis has been added as a rare potential adverse effect. It may occur at any point during therapy and can progress to renal failure. Omeprazole should be discontinued in case of suspected cases, and appropriate treatment promptly initiated.Revised SPC: Dysport (Clostridium botulinum type A toxin-haemagglutinin complex) 500 units Powder for solution for injectionAddition of pictograms showing the injection sites into the muscles.Revised SPC: Vaborem 1g/1g (meropenem, and vaborbactam) infusionRisk of interaction when administering Vaborem concomitantly with drugs metabolised by CYP1A2, CYP3A4, CYP2C and transported by P-gp which may result in decreased plasma concentrations of the co-administered drug.Revised SPC: Piqray (alpelisib) tabletsColitis and angioedema have been added as potential adverse effects of treatment (frequency unknown for both).Revised SPC: Revlimid (lenalidomide) Hard Capsules (all strengths)Dose for patients with severe renal impairment/end stage renal disease for follicular lymphoma indication updated based on additional pharmacokinetic analysis, as has existing warning highlighting men should not donate semen/sperm during treatment & for ≥7 days afterwards.

46. SPC changes or Manufacturer RMMRevised SPC: Dexamfetamine Sulfate 1 mg/ ml Oral SolutionDexamfetamine is in part metabolised via CYP2D6. Although the clinical significance of this interaction is likely to be minimal, attention should be paid when medications metabolised by these pathways are administered.Revised SPC: Lipitor (atorvastatin) 80 mg film-coated tabletsIn a few cases, statins have been reported to induce de novo or aggravate pre-existing myasthenia gravis or ocular myasthenia, and that treatment should be discontinued in case of aggravation of symptoms.Revised SPC: Amorolfine nail lacquer preparationsThe product contains 55.2% ethanol, and it includes warnings with respect to being a flammable substance that should not be used near an open flame, a lit cigarette or some devices (e.g. hair dryers).Revised SPC: Spikevax bivalent (elasomeran, imelasomeran)Chemical and physical stability has also been demonstrated for unopened vaccine vials for 12 months (previously 9 months) when stored at -50°C to -15°C and now notes preferred site of intramuscular administration is the deltoid muscle of the upper arm.Revised SPC: Covid-19 Vaccine JanssenSections 4.8 and 5.1 have been updated to include safety and immunogenicity data following a booster (second dose).

47. SPC changes or Manufacturer RMMEducational Risk Minimisation Materials to help reduce the risk associated with using Ximluci (ranibizumab) 10 mg/mL solution for injectionMaterials include patient audio guide & booklet covering how Ximluci works & is administered, as well as safety information, when used to treat neovascular(wet) AMD, choroidal neovascularisation, proliferative diabetic retinopathy, diabetic macular oedema & retinal vein occlusion

48. Drug shortages and discontinuationsRecent medicine shortages and discontinuations are available via: the SPS Medicines Supply Tool (registration required to access)Discontinuations highlighted by SPS supply tool in last monthLanoxin PG (digoxin) 50micrograms/ml elixirAbelcet 100mg/20mg concentrate for suspension for infusion vialsVenlafaxine (Venlalic) XL 37.5mg tabletsThis is not a comprehensive list.

49. Drug shortages and discontinuationsRecent medicine shortages and discontinuations are available via: the SPS Medicines Supply Tool (registration required to access)New Shortages highlighted by SPS supply tool where the MSN states MSO action requiredLidocaine 40mg/2ml (2%) solution for injection ampoules(MSN/2023/029*)Octreotide 50micrograms/1ml solution for injection vials (MSN/2023/040*)Streptokinase 250,000unit powder for solution for infusion vials (MSN/2023/038*)Ketamine (Ketalar) 10mg/ml solution for injection vial (Schedule 2 controlled drug) (MSN/2023/043*)[Oxycodone 5mg/5ml oral solution (MSN/2023/042), no MSO action but likely high impact]This is not a comprehensive list. Only critical safety medication shortages, where MSO action required, have been highlighted.

50. Specialist Pharmacy Service Using angiotensin-converting enzyme (ACE) inhibitors during breastfeeding Enalapril is the ACE inhibitor of choice during breastfeeding. Recommendations apply to full term and healthy infants only.Using lipid-lowering medicines during breastfeeding Rosuvastatin, pravastatin and atorvastatin are preferred; simvastatin and ezetimibe can also be used. Recommendations apply to full term and healthy infants.Using bisphosphonates with proton pump inhibitors (PPIs) Although no interaction between bisphosphonates and PPIs is documented, the increased risk of fractures when given together should be reviewed and managed.Poisoning and toxicity: resources to support answering questions Resources for primary care healthcare professionals to find information to answer questions about medicine toxicity or overdose.Identifying risk factors for developing a long QT interval Some medicines (erythromycin, citalopram, ondansetron) can cause a long QT interval. Consider risk factors and follow MHRA recommendations for safe use.

51. Specialist Pharmacy Service Understanding the characteristics of Comirnaty 10 Concentrate (for children 5-11 years) vaccine Update: Shelf life and storage - added maximum shelf life post dilution of 6 hours for microbiological reasons. Allergies, excipients and dietary advice moved to this page.Understanding the characteristics of Comirnaty Original / Omicron BA.4-5 vaccine An overview of the Comirnaty Original / Omicron BA4. 4-5 vaccine and signposts to other useful resources. NB: Allergies, excipients and dietary advice now moved into this article. Preparing Comirnaty Original / Omicron BA.4-5 An example SOP for preparing Comirnaty Original / Omicron BA.4-5 vaccine.Preparing Comirnaty 10 Concentrate vaccine Update: Change to SOP to state vial should not be used for longer than 6 hours post puncture for microbial reason.Understanding the characteristics of VidPrevtyn Beta An overview of the VidPrevtyn Beta vaccine and signposts to other useful resources. NB: Allergies, excipients and dietary advice now moved into this article.Preparing VidPrevtyn Beta vaccine An example SOP for the preparation of VidPrevtyn Beta vaccine.Managing COVID-19 Vaccines: Guidance and SOPs Update: inclusion of vaccines used in spring 2023 campaign.

52. Specialist Pharmacy Service Ordering, receiving and storing COVID-19 vaccines Update: SOP and page updated to remove reference to frozen storage / thawing of vaccines as this is no longer routine practiceTransporting COVID-19 vaccines Update: SOP HCV 6 updated to reflect vaccines used in spring 2023 campaign.Interactions information for COVID-19 vaccines Update: Updated to reflect co-administration with other vaccines advice in green book.Safe and secure handling, spillage and disposal of COVID-19 vaccines Update: Attachment SOP HCV 7 updated following launch of VidPrevtyn Beta. Now states defaced cartons may be disposed of via general waste stream.The legal mechanisms available for giving COVID-19 vaccines and their application Update: Minor formatting amendments to reflect changes to a single NP and single PGD for spring campaign.Amendments to the expiry date on cartons of COVID-19 vaccines Update: Nuvaxovid and Comirnaty Original/Omicron BA.4-5 expiry extensions added.

53. Specialist Pharmacy Service Pharmacy responsibilities for management of stocks of oxygen and other medical gases Update: NHS Protect guidance on security and storage of medical gas cylinders added.Patient Group Direction use in virtual ward services Considerations required before implementing Patient Group Direction (PGDs) for in virtual ward services.Patient Group Direction use by temporary professional registrants Update: Minor updates to text to reflect changes in temporary registers in response to their extension.Retaining legal mechanism documentation Update: PSD record keeping information added.SPS Spotlight Monthly Digest March slide deck summarising new and existing materials from across SPS, and signposting to upcoming events and activities. Please distributed to relevant healthcare professionals and their teams.New Medicines News March highlights of recent new product launches and significant medicines regulatory changes.Medication Safety Update Update: March - latest medication safety communications and publications to inform, support and inspire medication safety improvements.

54. Specialist Pharmacy Service The following Intrathecal medicines pages have updated links:Baclofen products: information for supporting intrathecal risk assessmentColistimethate Sodium products: information for supporting intrathecal risk assessmentCytarabine products: information for supporting intrathecal risk assessment  Levobupivacaine products: information for supporting intrathecal risk assessmentOmnipaque products: information for supporting intrathecal risk assessmentTrastuzumab products: information for supporting intrathecal risk assessment

55. National guidance, publications and resources UKHSA All influenza vaccines marketed in the UK for the 2023 to 2024 seasonThe table lists all of the vaccines that are marketed in the UK for the 2023 to 2024 flu vaccination season, including ovalbumin content. (Information on use of influenza vaccines in egg allergic individuals can be found in the green book (Chapter 19)).COVID-19 vaccination: spring 2023 booster resourcesPatient information on the spring 2023 booster dose for eligible individuals.British Menopause Society Joint BMS FSRH RCGP RCOG SfE and RCN Women's Health Forum safety alertJoint safety alert from 6 leading UK health bodies has been published in response to concerns about requests from private clinics to prescribe high doses of oestrogen, outside of product licence & sometimes with insufficient progestogen, for women experiencing menopause symptoms.SIGNNational clinical guideline for stroke for the UK and IrelandThis partial update of 2016 edition, developed in collaboration with SIGN & National Clinical Programme for Stroke, Ireland, is endorsed for use in clinical practice by RCP (London), SIGN & RCP (Ireland). Of 538 recommendations, almost 300 have been updated, added or endorsed.Pharmacological management of migraine - updated SIGN guidelineFollowing a scoping review, this guideline has been updated to include revised safety advice on use of topiramate, candesartan, flunarizine and CGRP monoclonal antibodies, SMC advice on eptinezumab, and recommended use of sodium valproate restricted to patients > 55 years.

56. National guidance, publications and resources NHSE Community pharmacy oral anticoagulant safety audit 2021/22Findings show there is still significant scope to improve the safety of patients who require anticoagulation, with no improvement in patient knowledge since 2017/18 audit. Although pharmacy teams can play a key role, wider discussion is required about the role of the wider MDT.Community Pharmacy Quality Scheme: 2019/20 high risk medicines audit report – Lithium, methotrexate, amiodarone and phenobarbitalA total of 40,419 patients were audited as part of this PQS scheme by 10,673 pharmacy contractors. Some patients were identified who were not routinely receiving appropriate monitoring for high-risk medicines. Systems should be improved to ensure monitoring is in place for all patients taking these high-risk medicines.NHS delivery and continuous improvement review: findings and recommendationsActions from review conducted by Anne Eden are to establish a national improvement board, launch a single, shared ‘NHS improvement approach’, and co-design and establish a Leadership for Improvement programme.NHS DigitalMedicines and Pregnancy Registry - Antiepileptic use in females aged 0 to 54 in England: April 2018 to September 2022An analysis of valproate prescribing in female patients aged up to 55 between April 2018 and September 2022 shows a reduction of over 9,092 in that timeframe (18,349 vs 27,441). Of the women taking valproate in September 2022, over 50% were under 45 years old.NICEGenedrive MT-RNR1 ID Kit for detecting a genetic variant to guide antibiotic use and prevent hearing loss in babies: early value assessmentNICE recommends that this can be used while further evidence is generated as an option for detecting the genetic variant m.1555A>G to guide antibiotic (aminoglycoside) use and prevent hearing loss in newborns who are being considered for treatment with aminoglycosides.

57. National guidance, publications and resources HSIB Safety risk of air embolus associated with central venous catheters used for haemodialysis treatmentThis report explores factors that affect the ability of staff to safely access haemodialysis catheters, its findings, safety observations, and three resultant recommendations to the General Medical Council and MHRA.Failing to communicate: challenges with electronic communication systemsArticle notes that electronic administrative systems have been chosen to meet organisational needs and the requirement for connectivity with other organisations may not have been predicted at the time of purchase. It discusses potential patient safety problems with this issue.NIHR Alert Combination therapy for painful diabetic neuropathy is safe and effectiveCommentaries provided on RCT comparing pregabalin, amitriptyline, & duloxetine showing combinations of these drugs are safe, and equally effective at relieving pain, so clinicians can be reassured patients can be started on any one of the 3 and have another added, if needed.Antipsychotics are increasingly prescribed to children and teenagersExpert commentaries on findings that 0.3% of children and young people in England were prescribed antipsychotics in primary care at least once between 2000 and 2019, with rates doubling during this period, raise concerns due to lack of safety and efficacy data for this age group.DHSCGovernment announces national ‘swap to stop’ scheme designed to encourage one million smokers to swap cigarettes for vapes to reduce smoking ratesOne in 5 of all smokers in England will be provided with a vape starter kit alongside behavioural support as part of a series of new measures to help the government ambition to be smoke-free by 2030. Pregnant women will also be offered financial incentives to help them quit.

58. National guidance, publications and resources King’s FundThe rise and decline of the NHS in England 2000–20: How political failure led to the crisis in the NHS and social careReport notes NHS has just come through its most difficult winter in living memory. Rather than attributing current situation to some inevitable built-in decay, it draws out the decisions (or lack of them) that have led to the current crisis.Pharmacist prescribing – professional revolution or damp squib?From 2026, pharmacy graduates registered with GPhC will automatically become prescribers. In guest blog, former CPO for England fears yet another innovation to help transform patient care could just fall over cliff edge into world of piecemeal & largely unplanned utilisation.Pharmaceutical Services Negotiating CommitteeSummary Care Record (SCR) to be replaced by National Care Records Service  (NCRS)In September 2023, the SCR will be replaced by the NCRS, which enables view of SCR information but additionally view of Personal Demographics Service, National Record Locator, and Reasonable Adjustments Flag; locally held care plans can also be included.

59. National guidance, publications and resources Pharmaceutical JournalPharmacy audit finds one in three patients taking lithium unaware of toxicity warning signsIn an audit of 40,419 patients under the Pharmacy Quality Scheme, 34% were unable to describe the signs of lithium toxicity. Additional counselling was provided by the pharmacy 23,957 times during the audit, where answers to the audit questions suggested this was required.Government warned repeatedly to better regulate supply of drugs online after series of deathsAn analysis of coroner’s reports by the Pharmaceutical Journal has revealed concerns about the regulation of supply of dugs online have been raised in 20 reports since 2013; including for example that many dangerous drugs are “freely marketed” with “no regulation” in supply.Audit finds fewer than one in ten patients carry anticoagulation safety cardLatest community pharmacy (CP) oral anticoagulant safety audit, which took place Sept 2021 to Mar 2022, with data from 131,526 patients attending 9,303 pharmacies, found just 8% prescribed an anticoagulant were carrying their yellow anticoagulant card when visiting CP.Third of women taking anti-seizure medication unaware of pregnancy risks, survey revealsA survey by Epilepsy Action found that 33% of women and girls taking carbamazepine, phenobarbital, phenytoin, pregabalin or topiramate were unaware of the increased risk of physical birth abnormalities if taken in pregnancy. However, awareness of risks of valproate had improved.

60. National guidance, publications and resources Prenatal Exposure to Antiseizure Medication and Incidence of Childhood- and Adolescence-Onset Psychiatric DisordersCohort study (n=38,661 children) found prenatal exposure to valproate was associated with an increased risk of psychiatric disorders (aHR 1.80; 95% CI 1.60-2.03). Associations were also found for topiramate with ADHD (2.38; 1.40-4.06) and levetiracetam with anxiety and ADHD.JAMA NeurologyAntiseizure Medication Use During Pregnancy and Neonatal Growth Outcomes: A Systematic Review and Meta-AnalysisReview (65 studies) found pregnant people exposed to these drugs had increased risk of small for gestational age (RR 1.33, 95% CI 1.18-1.50, I2 74%) and low birth weight (RR 1.54, 95% CI 1.33 to 1.77, I2 67%) babies. Polytherapy was linked to higher risks compared to monotherapy. British Journal of Clinical Pharmacology

61. Prevention of Future Death Reports (Regulation 28)Ref: 2023-0107Propranolol prescribed for anxiety by a locum GP 6 months previously, recently changed to sertraline. An overdose of remaining propranolol was taken as an impulsive act, after which help was sought, the provision of which was delayed. Individual rang the Crisis Team and NHS 111 within 30 minutes of taking the overdose. Two opportunities were missed to send an ambulance sooner which may have meant her reaching hospital at least two hours earlier than she eventually did.Cause of deathIntentional Propranolol OverdoseAnxiety & Mood Disorder ConcernsNo advice given to safely dispose of propranolol which was no longer required/prescribed – propranolol is known to be cardiotoxic in overdose and the patient was known to be in a potentially fragile mental state (recent prescription of sertraline for depression/anxiety).

62. Prevention of Future Death Reports (Regulation 28)Ref:2023-0106The individual inhaled the contents of a number of nitrous oxide cannisters. She started to wheeze and used her blue inhaler. She declined an ambulance and collapsed as she was going outside to get air. An ambulance was called and her friend performed CPR. She was resuscitated but died the next day.Cause of death Inhalation of Nitrous Oxide compounding Asthma ConcernsThe present legal framework concerning Nitrous Oxide should be reviewed, in the light of this death, having regard to the seemingly increasing use of Nitrous Oxide particularly by young persons.

63. Primary research- Medication SafetyFrequency of nursing student medication errors: A systematic review.The frequency of nursing student medication errors is high. The safe administration of medications is an important skill that nursing students should learn. At a theoretical and practical/clinical level, it would be advisable for clinical nurses and academics to jointly develop an educational program to acquire correct knowledge and perceptions regarding safe medication administration. (Greece)medRxiv (In press)Is primary care a patient-safe setting? Prevalence, severity, nature, and causes of adverse events: numerous and mostly avoidableKnowing the frequency and characteristics of adverse events is key to implementing actions that can prevent their occurrence. A high prevalence of adverse events (1 in 66 consultations) was observed, which was slightly higher than those reported in similar studies. About three out of four such events were considered to be avoidable and one out of 13 were severe. Prescription errors, drug administration errors by patients, and clinical assessment errors were the most frequent types of adverse events.Int J Qual Health CareMedication errors in community pharmacies: Evaluation of a standardized safety program.Using reports to the Canadian AIMS programme the authors found that most frequent event types involved the incorrect drug (19.5%), concentration (17.2%) or quantity (14.5%). Approximately 25% of events were identified by the involved patient or their agent. When looking at medication classes, antihypertensives, opioids and antidepressants were involved in over one-quarter of overall and higher severity events. Environmental staffing problems and interruptions were the contributory factor and sub-factor most frequently reported, respectively.Exploratory Research in Clinical and Social PharmacyThe Value of Learning From Near Misses to Improve Patient Safety: A Scoping Review4,745 articles were identified. Health care assumes that reporting and learning from near misses improves patient safety. The literature provides limited evidence supporting these assumptions and shows that actions as a result of near misses are commonly aimed at the humanJ Patient Safety

64. Primary research- Medication SafetyImplementation status of safety measures to prevent errors with non-oncologic methotrexate: surveys in community and hospital pharmacies.Accidental overdose of low-dose methotrexate can lead to serious patient harm. Safety in relation to methotrexate in pharmacies relies mostly on staff instructions, which are considered weak measures. In light of the serious risk imposed on patients, pharmacies should set a focus on stronger IT-based measures that rely less on human performance.International Journal of Clinical Pharmac (in press)Analysis of the nature and contributory factors of medication safety incidents following hospital discharge using National Reporting and Learning System (NRLS) data from England and Wales: a multi-method study.Medication incidents after hospital discharge are associated with patient harm. A total of 1121 medication-related incident reports underwent analysis. More than one in 10 incidents were associated with patient harm. The drug monitoring (17%) and administration stages (15%) were associated with a higher proportion of harmful incidents than any other drug use stages. The most common contributory factors were organisation factors (82%), followed by staff factors (16%).Therapeutic Advances in Drug Safety. (in press)"Are we there yet?" Ten persistent hazards and inefficiencies with the use of medication administration technology from the perspective of practicing nurses(1) Compatibility constraints (2) Missing action cues (3) Intermittent communication flow between safety monitoring systems and nurses (4) Occlusion of important alerts by other, less helpful alerts (5) Information required for tasks is not collocated; (6) Inconsistent data organization (7) Hidden medication administration technologies (MAT) limitations (8) Software rigidity causes workarounds (9) Cumbersome dependencies between technology and the physical environment (10) Technology breakdowns require adaptive actions.J Am Med Inform AssocNursing Student Errors and Near Misses: Three Years of DataUnderstanding the magnitude of errors and near misses in all health care situations is crucial to preventing them from occurring in the future. Medication errors represented more than half (58.8%) of the total error and near-miss data (n = 1,042) submitted. Errors and near misses were attributed to students not adhering to three major patient safety procedures: checking the patient's identification, checking the patient's allergy status, and following the rights of medication administration.J Nurs Educ

65. Thank you to our presenters Polly, Sarah, Tony and ChristineHow can we continue to work together? All ideas welcomeDo you have an interesting case or project that you would like to share at a future webinar?Email lnwh-tr.sps-mso@nhs.netReminder Joint EPMA/MSO webinar Wednesday 17th May 1-2pmMay MSO webinar Wednesday 31st May 1-2pmThank you for your time