TRUST BOARD MEETING PUBLIC. CQC Registration standards 12(2)f and 12(2)g (Medicines Management)

Transcription

1 TRUST BOARD MEETING PUBLIC To be held on Wednesday 3 rd August 2016 Title of Report: Medicines Management Annual Report for Sponsoring Director: Author(s): Michelle Norton - Director of Nursing Paul Mills - Chief Pharmacist Background Paper(s): Assurance Framework Link(s): CQC Link(s): 2.2.2; 5.3 CQC Registration standards 12(2)f and 12(2)g (Medicines Management) Corporate Objective(s) supported by this paper:- (please tick) Patient care/experience Service Delivery Service Development/ Stakeholders Achieving targets Workforce Legal Implication(s): Resource Implication(s): Compliance with UK medicines legislation; Specific reference to Responsible Pharmacist regulations; Controlled drugs regulations; MHRA licensing. There may be cost implications to implement action identified by routine ward medicines management & controlled drug audits, and to implement national directives. Use of Netformulary software to manage the hospital formulary will incur an annual cost of 4K Additional manpower costs will be incurred to sustain the current level of activity being delivered from the pharmacy aseptic unit. Cost associated with procurement and implementation of electronic prescribing. Impact on Health Inequalities including Equality & Human Rights: Patient and/or Public Involvement: Purpose of Report: The Trust continues to follow national and local best practice. There is patient membership on both the Drugs & Therapeutics Committee and the Medicines Management Group. To provide an annual update to the Trust Board for on pharmacy and medicines management issues within the Trust 1 PEM/Medicines Management Annual Report to the Trust Board /

2 Report Summary: 1. Compliance with CQC medicines management standards (standards 12(2) f and 12(2)g) was generally maintained during A series of CQC-style inspection visits to clinical areas, co-ordinated by the Governance Team, identified some non-compliances which have been reported to the appropriate ward managers for action. Implementation of an automated, wireless temperature monitoring system would improve compliance with medicines storage temperature monitoring across the Trust. 2. The number of reported medicines-related incidents was sustained during , with an average of 48 incidents per month being reported. National data from the NRLS shows this puts this Trust 58 th out of 139 acute Trusts (the highest rate of reporting being first), with an incident rate of 4.26 incidents per 1000 bed days, suggesting a healthy reporting culture. 3. A substantive Medication Safety Officer was appointed in March 2016, following a re-organisation within the pharmacy team, to further promote the reporting, investigation and dissemination of learning from medicines-related incidents within the Trust. 4. An independent report prepared by the Head of Governance highlighted concerns regards the number of reported medicines-related incidents associated with moderate harm. An action plan to deliver the report s recommendations has been approved by the Medicines Management Group. The plan aims to reduce medication related incidents associated with moderate harm by 20% in (compared to ). 5. The Trust completed an updated self-assessment against the TDA s Medicines Optimisation Framework in March A series of 6 assessment criteria in each of 6 domains were assessed. A score between 1 and 4 was assigned to each criterion. The Trust sustained its previous score in Further improvement is anticipated now that a substantive Medication Safety Officer has been appointed. An action plan to achieve further improvement has been prepared by the Medical Director, Director of Nursing and Chief Pharmacist. 6. Following publication of the Carter report, Operational productivity and performance in English NHS acute hospitals: Unwarranted variation in February 2016, the Trust has compiled an action plan to deliver a Hospital Pharmacy Transformation Programme (HPTP) by April The executive lead for the Carter programme, including the HPTP, is the Director of Finance. 7. Seven day working for the pharmacy team was sustained during The Sunday dispensing service facilitated an average of 15 patient discharges (range 7-26) each Sunday, freeing up beds for new admissions. 8. The ward-based processing of EDS TTOs by the pharmacy team was continued during , to expedite the preparation of medicines for discharge. 9. The pharmacy department continued to complete over 95% of outpatient prescriptions within 30 minutes of presentation (average turnaround time 17 minutes), whilst the average 2 PEM/Medicines Management Annual Report to the Trust Board /

3 turnaround time for discharge prescriptions (which invariably include more items) was 57 minutes. 10. The pharmacy aseptic unit showed a sustained increase in workload as a result of increased demand for cancer chemotherapy and for intravenous nutrition in Meeting immediate demands for these products has resulted in delays in issuing stock from the pharmacy computer system and hence delays in reclaiming payments from commissioners. The collation of monitoring data for the unit has also been compromised. A business case for additional preparation (pharmacy) and administration (nursing) staff has been prepared by CBU5 and is awaiting approval. 11. The medicines management audit programme was curtailed in owing to manpower constraints in both nursing and pharmacy teams. Despite these constraints, useful audit was completed and shortcomings identified were acted upon. 12. Medicines security audits have highlighted ongoing noncompliances, particularly on the Acute Medical Unit. Following a successful bid to the Nurse Technology Fund, funding has been secured for three Omnicell cabinets, electronic drug storage cabinets which use fingerprint identification to access and remove the need for keys. These will be deployed on AMU, A&E and the emergency medicines cupboard. Deployment is anticipated in early The Trust continued to participate in the national Medication Safety Thermometer tool during Comparative data with other participating Trusts suggest the frequency of missed doses, including missed doses of critical medicines (anticoagulants, opiates, insulin, anti-infectives) is higher in this Trust than nationally. Ward managers are becoming more actively engaged in data collection so as to foster ownership, enhance understanding of the issues and promote corrective action.` 14. The Trust s Antimicrobial Stewardship Group, Chaired by Dr Sam George (Consultant Anaesthetist) met three times in Its terms of reference are in accordance with the requirements of the ARHAI s document Start Smart then Focus. A workplan have been established, based on the requirements of a national ARHAI self-assessment tool, NICE NG15 and the national CQUIN for antimicrobial prescribing (for ) 15. The medicines-related working groups, including the Drugs & Therapeutics Committee, Medicines Management Group, Medical Gases Group, Non-Medical Prescribers Group and Nutritional Steering Group continued to operate effectively in delivering their respective remits during The Chief Pharmacist and Chair of DTC remain active members of the Coventry & Warwickshire Area Prescribing Committee. Recommendation(s): That this report be approved by the Trust Board. 3 PEM/Medicines Management Annual Report to the Trust Board /

4 Acronyms and Abbreviations ADSL Acute Drugs Status List APC Area Prescribing Committee ARHAI advisory committee on Antimicrobial Resistance and Healthcare Associated BNF British National Formulary CDU Clinical Decisions Unit CIP Cost Improvement Programme CLRN Comprehensive Local Research Network CPD Continuous Professional Development CQC Care Quality Commission CQUIN Commissioning for QUality and INnovation CWPT Coventry & Warwickshire Partnership Trust DARE Department of Audit, Research and Evidencebased medicine DDD Defines Daily Doses DKA Diabetic Keto-Acidosis DoH Department of Health DTC Drugs & Therapeutics Committee EDS Electronic Discharge Summary EPMAR Electronic Prescribing and Medicines Administration Recording ESCA Essential Shared Care Agreement HSCIC Heath Service Clinical Information Centre ICH - IMP International Conference on Harmonization Good Clinical Practice (in clinical trials) Investigational Medicinal Product IPACC Infection Prevention And Control Committee KSF Knowledge & Skills Framework LIN Local Intelligence Network (for controlled drugs) MGPS Medical Gas Pipeline System MHRA Medicines & Healthcare-related products Regulatory Agency MI Medicines Information MMG Medicines Management Group NHSLA National Health Service Litigation Authority NICE National Institute of health and Clinical NPSA National Patient Safety Agency NR Not Recommended NVQ National Vocational Qualification PBR Payment By Results PCA Patient Controlled Analgesia PDP Personal Development Plan PDSA Plan-Do-Study-Act (a service improvement technique) PGD Patient Group Directions PID Project Initiation Document PPL Preferred Prescribing List SC Shared Care (ESCA required) SI Specialist Initiation SO Specialist Only TDA Trust Development Authority TPN Total Parenteral Nutrition (intravenous nutrition) TTO To Take Out medicines WHO World Health Organisation 4 PEM/Medicines Management Annual Report to the Trust Board /

5 Action plan for planned developments & enhancements for Development / enhancement Produce Hospital Pharmacy Transformation Programme, as required by the Carter report. Action By who By when Implement agreed action plan Various, as on action plan Apr 17 Further encourage reporting of no-harm and low-harm and medicinesrelated incidents Implement action plan to achieve enhanced compliance with all elements of the TDA s Medicines Optimisation Framework Complete proposed enhancements to EDS system, as they relate to pharmacy practice. Complete Medicines Management audit programme for Deploy Netformulary software, to manage the Trust s medicines formulary Implement national alerts and other national reports within required timescales Contribute to the procurement and implementation of Electronic Prescribing & Medicines Administration (EPMA) within the Trust. Deploy Omnicell cabinets on AMU, A&E and Medicines Emergency Cupboard Implement wireless temperature monitoring system Trust-wide Remind all clinical staff at induction and mandatory update. Regular discussion at multidisciplinary Medicines Management group. MMG members to promote in their clinical areas. New MSO to identify and promote initiatives Progress with action plan to be monitored bi-monthly by Medicines Management Group. Modification to enable choice of pharmacy printer remains outstanding (on Risk Register) Progress with the programme to be overseen by the Medicines Management Group Set up Netformulary template to reflect local Trust formulary The Medicines Management Group ensures national alerts and other national reports are actioned within required timescales. Actively participate in the Lorenzo project with regards to EPMA. Contribute to other initiatives to secure EPMA for the Trust (e.g. external funding bids). Complete configuration, installation and staff training, in accordance with the project plan Secure capital funding for the project and deploy when approved. MMG, Pharmacy team, MSO MMG, Director of Nursing, Chief Pharmacist IT dept Apr 16 and ongoing Mar 17 Dec17 MMG Mar 17 Formulary Pharmacist Aug 16 MMG Mar 16 and ongoing Chief Pharmacist Omnicell Project Team MMG, Director of Nursing, Chief Pharmacist Apr 16 and ongoing Apr 16 and ongoing Jul 16 Mar 17 5 PEM/Medicines Management Annual Report to the Trust Board /

6 1. Care Quality Commission Registration Standards: Standard 12(2)f and 12(2)g (Management of Medicines) Care Quality Commission registration standards were revised in , with performance being assessed in each of 5 domains safe, effective, caring, responsive and well led. Medicines management is now included in the safe domain, though aspects of care involving medicines fall into all domains. Table 1: Compliance with Standard 12(2)f and 12(2)g based on self-assessment Item Standard Current performance 12(2)(f) Where equipment or medicines are supplied by the service provider, ensuring that there are sufficient quantities of these to ensure the safety of service users and to meet their needs; Pharmacy stock is managed using a JAC computer system. Ward stock lists are reviewed every 6 months. Wards stocks are replenished 2-3 times a week. Medicines must be available to meet patient s needs, to avoid missed doses. Sufficient medication should be available in case of emergencies. Medicines are available when care is transferred 12(2)(g) The proper and safe management of medicines; Staff responsible for the management and administration of medication must be suitably trained and competent and this should be kept under review. Staff must follow policies and procedures about managing medicines (details of required policies specified) including those related to infection control. Emergency cupboard containing range of medicines available out-of-hours. An on-call pharmacist is available when pharmacy is closed. A minimum of 14 days supply of medication is provided to patients on discharge. The re-supply of medicines resulting from a failure to transfer medicines between wards is monitored. All clinical staff, including senior medical staff, receive a medicines management session as part of their induction AND an annual mandatory update. In addition, nurse training in medicines management is provided as part of a mandatory clinical study day. Policies and procedures relating to the supply, storage, preparation, administration, disposal and recording of medicines are updated as part of a rolling programme, overseen by the MMG and DTC. During , a series of internal CQC-style inspections were completed in identified clinical areas, co-ordinated by the governance team, to assess compliance at ward/department level. The Chief Pharmacist was an active participant in some of these inspections. The aggregated issues highlighted by these inspections with regards to medicines management practice is summarised below. Individual reports of noncompliances identified in specific clinical areas, with action plans, were presented to those areas. Controlled drugs: Missing second signature for disposal of part-used ampoules / vials Missing second signature for administration (very infrequent) Corrections in CD book not compliant with guidelines (i.e. brackets or single line) Record of daily controlled drug stock check not completed on some days Receipts of controlled drugs not always recorded in words 6 PEM/Medicines Management Annual Report to the Trust Board /

7 Other medicines management issues Failure to label in-use insulin pens Records of monitoring of fridge and room temperature missing on some days Occasional breaches of medicines security (infrequent) Patients own medicines not returned to patient or to pharmacy (for disposal) after patient left the ward Not consistently recording date opened on oral liquid medicines Process for managing outpatient prescriptions not robust Implementation of an automated, wireless temperature monitoring system would improve compliance with medicines storage temperature monitoring across the Trust. This multi-disciplinary programme supports the regular audits of controlled drugs and medicines management practice undertaken by the pharmacy team (section 4.6). 2. Medicines Optimisation Framework In August 2013, the Trust submitted its response to the Trust Development Authority s Medicines Optimisation Framework, a document which assesses the Trusts medicines management structures and practice against a range of 6 domains, each having 6 assessment criteria, to which a score between 1 and 4 is assigned. Table 2: Changes in compliance with Medicines Optimisation Framework since initial assessment Domain Domain description Initial score Score end Score end Action taken to achieve improvement 1.1 Optimisation strategy Optimisation Strategy approved by DTC 2.3 Medication incident reporting 2.5 Policies to minimise risks from medicines 3.1 Effective decision making process for medicines use 3.3 Routine medicines audits 3.5 Implementation of NICE guidance 4.6 Transfer of care and pharmaceutical care plans 5.4 All medicines are stored appropriately 5.5 Controlled drugs are managed safely and effectively 5.6 Areas where medicines are stored, dispensed, prepared and administered are monitored and maintained Trend data on common incident types included on monthly Quality Report; Medication Safety Thermometer in use on 10 wards Register of PGDs maintained in pharmacy Business plan for DTC compiled and approved by DTC Medicines Management audit programme amended to include assessment of Homecare DARE systems for monitoring compliance with NICE have been improved Audit of recording changes to regular medicines not completed in (completed in early 16-17_ Medicines storage temperature monitoring policy updated Chief Pharmacist attends and contributes to Local Intelligence Network meetings on behalf of the Accountable Officer. Annual report on controlled drugs presented to the Trust Board Medicines policy updated, to include a specification for clinical rooms where medicines are stored and prepared. 7 PEM/Medicines Management Annual Report to the Trust Board /

8 The six domains are: Strategy, risk and governance Safe use of medicines Effective choice of medicines The patient experience Environment for medicines optimisation Workforce for medicines optimisation The assessment was completed following a discussion between the Medical Director, Director of Nursing and Chief Pharmacist. An overall score of 89/144 was achieved in An action plan was compiled to enable the Trust to achieve at least level 3 for all assessed criteria. The Framework was updated nationally during , to reflect the requirements of NHS/PSA/D/2014/005, Improving medication error incident reporting and learning. A reassessment was completed in March 2016, which demonstrated that the score had not changed since the previous assessment in March 2015, as a result of the delayed appointment of a substantive Medication Safety Officer. This specialist pharmacist started in post in March 2016, so did not influence the score before year end. The two areas where performance remained at level one at the end of are self medication and electronic prescribing. A new action plan to further develop medicines management practice within the Trust has been agreed by the Medical Director, Director of Nursing and Chief Pharmacist for The Carter report and the Hospital Pharmacy - Medicines Optimisation (HOPMOP) programme In November 2015, Trust-specific feedback was provided from the Carter review team comparing this Trust with data derived from the Ideal Hospital model, a model developed by the Carter team from an analysis of data from 23 acute hospitals of varying size. This analysis showed the Trust to have a lower-than-average staff cost per unit of Cost Weighted Output (CWO) ( a metric devised by the Carter team) ( for GEH compared with a benchmark of ), a lower-than-average medicine cost per unit of CWO ( 0.07 for GEH compared with 0.10 benchmark) and a lower-than-average number of staff (4.01 FTE/ 10m CWO for GEH compared with a benchmark of 5.04). These data suggest the pharmacy department is very efficient in delivering cost-effective medicines management but with very limited manpower. The Carter report, Operational productivity and performance in English NHS acute hospitals: Unwarranted variation was subsequently published in February The report highlights that the NHS spends 6.7bn on medicines in hospitals, managed by just 7000 pharmacists, supported by pharmacy technicians and other staff. The ethos of the report is that these limited pharmacy resources should focus on medicines optimisation ensuring patients derive the optimum benefit from the medicines they are prescribed. Medicines Optimisation, as promoted by the Royal Pharmaceutical Society, requires a patient-centered approach, guided by 4 principles: Aim to understand the patient s experience Evidence-based choice of medicines Ensure medicines use is as safe as possible Make medicines optimisation part of routine practice This approach seeks to ensure that the high level of expenditure on medicines by the NHS is well spent, by ensuring appropriate medicines are selected for the individual, that the patient is bought in to the decision to take the medicines (reducing waste) and that the patient 8 PEM/Medicines Management Annual Report to the Trust Board /

9 knows how to use them correctly and safely so as to derive the optimum health gain from those medicines. The report requires hospital pharmacies to review the support services currently provided, so as to identify whether there are affordable options for providing those services by different mechanisms so as to enable the hospital pharmacy team to be more focussed on medicines optimisation activities. This may involve collaboration with other providers within or outside the NHS. To this end, all acute Trusts are required to produce a Hospital Pharmacy Transformation Programme by April This Trust has nominated the Director of Finance as the lead for implementation of the requirements of the Carter review, including HOPMOP. An action plan has been compiled, with input from the Chief Pharmacist, to clarify the tasks to be completed. This action plan will evolve during the course of , to deliver the HPTP by the required deadline. A series of national metrics, still to be issued, will be used to assess Trusts performance in delivering improvements in Medicines Optimisation. 4. Pharmacy Operations 4.1 Staffing: The pharmacy team remained quite stable during , though a number of concurrent vacancies and requests for hours changes meant that it was possible to review the previous structure with a view to appointing a substantive Medication Safety Officer within the same financial envelope as previously. In addition to the replacement of staff in fixed-term training positions (pre-registration pharmacists and pre-registration pharmacy technicians), four pharmacists, three technicians, two pharmacy assistants, one clerical officer / receptionist and two pharmacy messengers were replaced during the year. A locum pharmacist was employed from June 2015 until the end of the financial year (and beyond) to back fill the sequence of pharmacist vacancies Agency cover was used to cover the vacant band 1 messenger posts during , pending substantive recruitment. A senior technician (band 6), to support pharmacy co-ordination of an expanded medicines homecare service, was sustained during This post continues to be funded from VAT savings on homecare medicines provided to rheumatology patents repatriated from UHCW, as part of an ongoing funding arrangement with Warwickshire North Clinical Commissioning Group. From September 2014, the availability of the pharmacy service was extended to 7 days with the pharmacy department providing a dispensing service on Saturdays and Sundays as part of the pharmacy team s normal hours, following a formal management of change process. This dispensary-based service is provided 09:00 to 13:00 on Saturday and 11:00 to 14:30 on Sunday. The Saturday service provides a dispensary service for urgent inpatient needs and discharges, whilst the Sunday service (provided by a smaller team) is for discharges only. A new band 3 dispensing assistant has been appointed, to provide back fill for staff rotered to work shifts at weekends, as part of 7 day working. This post was funded by monies allocated for weekend working and the expansion of AMU. The revised pharmacist rota, initiated in November 2012, continued to reduce the number of cancelled pharmacist ward visits during , albeit with less time being spent on each visit (Figure 1). The reduced time available at each pharmacist visit, however, impacts on other areas of ward-based pharmacy practice, most notably routine inpatient prescription review and endorsement. It is envisaged that the future implementation of electronic prescribing will provide the opportunity for clinical pharmacists to focus their limited time on new 9 PEM/Medicines Management Annual Report to the Trust Board /

10 prescriptions and prescriptions requiring close monitoring (e.g. high risk medicines like gentamicin which require careful monitoring). Figure 1: Cancelled pharmacist ward visits per month New rota Introduced 4.2 Governance All substantive members of the pharmacy team, except two on 12-months maternity leave, were appraised using the Trust s approved documentation during and a personal development plan (PDP) agreed for Each appraisal included an assessment of their job performance, compliance with the core dimensions of their KSF outline and their understanding and implementation of the Trust s EXCEL value pledges Further appraisal dates are scheduled for Most members of the pharmacy team completed their required statutory and mandatory training update during , in accordance with the Trust-approved staff training matrix. Owing to pressure from workload demands, a small number of staff failed to complete retraining prior to the required deadline, but these were re-scheduled for completion shortly thereafter. The pharmacy department continued to provide training for Health Education West Midlands-funded pre-registration pharmacists (2 wte) and student pharmacy technicians, NVQ3 (4 wte) during Two wte centrally-funded pre-registration pharmacist posts and 4 wte student pharmacy technicians (NVQ3) have been approved for the September academic year. Two pharmacists successfully completed the first year of the Keele University clinical diploma programme during and have successfully progressed to year two, one supported by HEWM finding and the other by Trust funding. One further pharmacist started the course in January 2016, supported by Trust funding. He is expected to progress to year 2 in January A further pharmacist will start the course in January All have been identified on the pharmacy department s learning needs analysis for PEM/Medicines Management Annual Report to the Trust Board /

11 All registered pharmacists and technicians are required to complete at least nine pieces of Continuous Professional Development (CPD) each year, preferably using the General Pharmaceutical Council s on-line CPD record system, in order to maintain their registration. This is undertaken largely in the pharmacists and technicians own time. Some pharmacists and technicians within this hospital have been asked to submit their CPD entries for assessment by the General Pharmaceutical Council. To date, the feedback they have received has been excellent. 4.3 Responsible Pharmacist Regulations The responsible pharmacist regulations came into force on The regulations require each registered pharmacy premises to have one designated pharmacist as the Responsible Pharmacist at all times, for the name of that pharmacist to be prominently displayed and for a responsible pharmacist log (including start and stop times) to be maintained and retained for 5 years. Registration of the satellite outpatient dispensary was maintained during , enabling the dispensing of private prescriptions and the sale of over the counter medicines. Compliance with the Responsible Pharmacist regulations was sustained in the satellite dispensary throughout Medicines Reconciliation The pharmacy team continued to complete medicines reconciliation on adult inpatients on medical and surgical wards within the Trust. The documentation system devised at GEH, whereby medicines reconciliation disparities are documented in a dedicated section of the inpatient medicine chart, ensures this information moves with the patient should they transfer between wards, avoiding duplication of effort. Figure 2: Medicines reconciliation performance Figure 2 displays the percentage of adult inpatients on medical and surgical wards who had medicines reconciliation completed during their inpatient stay, based on the number of discharges from these wards. The use of discharges (rather than admissions) ensures that patients admitted via CDU, then transferred to a permanent ward, are not omitted from the denominator. Data from CDU, DPU and Maternity are not included as these areas receive 11 PEM/Medicines Management Annual Report to the Trust Board /

12 no clinical pharmacy service and have been identified as low risk for medicines reconciliation error, on the basis that these patients are either very short stay (CDU, DPU) or are generally well (Maternity). A new system for providing the ward-based pharmacy service has been in place since November The system was introduced with a view to ensuring wards get a visit from the pharmacist, albeit shorter than previously, on most days. The new system has reduced the number of ward cancellations (Figure 1), though the shorter visits mean that some tasks cannot be completed, particularly the routine review of inpatient medicine charts (for missed doses, antibiotic monitoring, dose and interaction checking etc). Overall, 78% of adult medical and surgical inpatients had medicines reconciliation completed during their inpatient stay during , higher than the 73% achieved in , reflecting the effort afforded to completing this important activity. It is unlikely that a significant further increase can be delivered with the current Monday to Friday service. The implementation of a weekend medicines reconciliation service will form part of the Trust s Hospital Pharmacy Transformation Programme, part of the Carter Review programme, which is scheduled to be submitted by (see section 3). 4.5 Audit An audit programme for medicines management for was compiled by the Chief Pharmacist and approved by the Medicines Management Group. This programme includes the annual rolling audit of medicines management practice, together with a 3-monthly rolling audit of controlled drugs practice, on all wards and departments within the Trust, conducted by pharmacy technicians using a proforma in use across the West Midlands. For , the regional proformas were updated, to include an assessment of issues raised as concerns in CQC visits to other acute Trusts. All non-compliances were highlighted to the appropriate ward manager and matron and reported as clinical incidents on Datix at the time of each audit. The collated results of these audits were presented to the Medicines Management Group in April As a result of the changes to the regional audit proformas for , non-compliances were identified in all clinical areas assessed. It is anticipated that an improvement will be observed in as appropriate remedial actions are implemented. The monthly medicines security inspections previously conducted by the Local Security Management Specialist and Health & Safety Officer were suspended in April 2016 when the LSMS left the Trust. The audit was reinstated in August 2016, supported by a Pharmacy Technician and the Health & safety Officer. The results of these audits were reported to the Medicines Management Group so that non-compliant wards can be followed up by the appropriate matron. Compliance was initially poor (non compliances identified in nine clinical areas) but improved over subsequent months. The use of lockable Pharmacy Delivery Units for medicines deliveries was continued in each clinical area. Following a successful bid to the Nurse Technology Fund in late 2014, funding was secured for three electronic medicines storage cabinets which use fingerprint recognition for access, avoiding the need for keys. The procurement process was completed during , with the order being awarded to Omnicell. The new Omnicell cabinets will be deployed on AMU, A&E and the Emergency Medicines Cupboard in early It is anticipated that these cabinets will improve medicines security in these clinical areas. A benefits realisation programme is in place, to demonstrate the impact of the new cabinets. This will be used to inform subsequent business cases for enable further roll out. Monthly audits of antibiotic usage (see section 6 below), medication errors (see section 7 below) and compliance with the Area Prescribing Committee formulary (a commissioned 12 PEM/Medicines Management Annual Report to the Trust Board /

13 quality standard for the Trust see section 9 below) have been completed and reported to the MMG and IPACC Throughout , the Trust submitted data to the Medication Safety Thermometer tool which prospectively assesses risks and harms from medicines use. Throughout , 10 wards (Adam Bede, Alexandra, Bob Jakin, CCU, Elizabeth, Felix Holt, Mary Garth, Melly, Nason and Victoria) were included in the assessment, with AMU being added in November The number of patients included in the audit rose from 200 in April 2015 to 238 in March In March 2015, the national co-ordinators of the tool launched a dashboard on their website, enabling individual Trusts to compare their performance against each other and the national average. The tool identified that compliance with allergy documentation was similar at this Trust (96.5%) to the national performance (96.8%) but not consistently at 100%. On average, 35.6% of patients at this Trust had at least one omitted dose of medication in the 24 hours prior to the audit, compared to 24% nationally. Of these 16.0% at this Trust (9.6% nationally) were not the result of patient refusal or another valid reason for omission. Whilst still above the national norm, this represents an improvement from , when total omissions were 42% with 18.6% for no valid clinical reason. National performance was virtually unchanged between the 2 years (last year s figures 25% and 9.3% respectively). Regards critical medicines, defined in the tool as anticoagulants, opiates, insulin or antiinfectives, a smaller proportion of patients were prescribed these medicines locally, compared to the national picture (29.3% versus 38.1% respectively) but on average 7.9% of doses were omitted at this Trust, compared to the national average of 6.8%. Follow up work provoked by these findings identified unsigned boxes on the medicine chart as a key contributor to the apparent high level of omission. It appears this may be the result of doses being given and not signed for rather than omitted. Work continues on tackling this problem, via the MMG. Ward managers are now actively encouraged to participate in data collection so as to foster ownership, enhance understanding of the underlying issues and to promote corrective action. The following ad hoc audits were also completed during : Audit of IV to oral antibiotic switching (presented to DARE multidisciplinary audit day, MMG and ASG). West Midlands Regional audit of medicines reconciliation (presented to MMG) West Midlands Regional audit of missed doses (presented to MMG) Airtube station security audit (presented to MMG) Non-medical prescribers audit ( ) (presented to MMG and NMP forum) Audit of refrigerator temperature monitoring on wards and departments (presented to MMG) Audit of temperature monitoring in the pharmacy department (refrigerators and room temperature storage areas) (presented to MMG) Audit of compliance with antibiotic prescribing policy (indication and duration documented) (presented to DTC, IPACC) Audit of medical gas pipeline system by Authorising Engineer (presented to MGG) Mandatory annual audit of compliance with thalidomide dispensing requirements (provided to manufacturer, Celgene). Nurse-led audits of compliance with the medicines administration procedure, the procedure for preparation and administration of intravenous medicines and NPSA alerts 19, 20 & 21 were started but not completed during as an appropriate audit lead could not be identified. A nurse was temporarily seconded to progress these audits in early 2015 but did not complete them. Options to ensure completion in have been discussed at MGG meetings, though these will be dependent on the availability of nurse time. 13 PEM/Medicines Management Annual Report to the Trust Board /

14 4.6 MHRA-licensed aseptic unit The MHRA- licensed aseptic unit continues to prepare a range of injectable products including cytotoxic chemotherapy and monoclonal antibody injections for cancer patients attending the Trust, intravenous nutrition (TPN) for patients requiring such therapy, morphine sulphate PCA bags along with several other injectables as required within the Trust. The unit, which houses 3 isolators in two clean rooms, prepared 6747 doses of individually dispensed cytotoxic drugs (for cancer chemotherapy) of which 1102 doses were of a monoclonal antibody. This compares with 6920 doses, of which 1180 were of a monocolonal antibody in , a slight fall in year but still a 22% increase over (Figure 3). The demand for intravenous nutrition (TPN) increased significantly during from 389 bags in to 624 bags in All patients on TPN were reviewed by the Nutrition Team, to ensure use was clinically appropriate so the increase is attributed to changes in the case mix of patients presenting. The preferred lipid source (SMOF-Kabiven) precludes the use of ready made bags, owing to their limited shelf life. The increase in activity therefore further increased the demands on the aseptic unit s capacity. In addition, 898 bags of morphine patient-controlled analgesia and 715 doses of other injectable medicines (including desferrioxamine and antibiotics) were prepared during Comparative numbers from were 1280 and 917 respectively. The aseptic unit is struggling to manage this workload, which exceeds its operational capacity. This has resulted in staff working additional hours and in the accumulation of stock on the pharmacy computer system whilst awaiting processing, which has in turn resulted in delayed claims for reimbursement of these tariff excluded medicines by commissioners. CBU5 is currently working with the pharmacy department on a business case to provide additional support to the aseptic unit and other areas of the hospital affected by the increase in oncology activity. Figure 3: Growth in preparation of cancer chemotherapy drugs The use of chemotherapy dose banding for some chemotherapy drugs was introduced in late Delayed implementation resulted from an absence of agreed national dose bands and delays in updates to the MOSAIC electronic prescribing system used at GEH but hosted by UHCW. From February 2016, dose bands were implemented for five commonly prepared chemotherapy drugs. Opportunities to purchase ready-made dose banded products, to alleviate pressure on the aseptic unit, are being explored, though this will 14 PEM/Medicines Management Annual Report to the Trust Board /

15 require a change in practice for chemotherapy nurses, as individual doses will be provided in multiple syringes of different size (not a single syringe as at present). A Q-pulse quality management system was in place during early , to facilitate the management of documents and monitoring data associated with the pharmacy aseptic laboratory, as recommended at the previous MHRA inspection of the unit. It has proved to be very effective for document control but further roll out has been impeded by the constraints of time, resulting from the workload increase described above. The systems for aseptic preparation of products for individual patients (covered by section 10 of the Medicines Act) were independently re-inspected by an inspector from Quality Control North West in November This EL(97)52 Farwell audit complements the MHRA inspection. Work to implement the recommendations of the report continues. A further Farwell audit will be conducted in Medicines information The Medicines Information (MI) section of the pharmacy department continues to operate with a low level of pharmacist manpower (0.1wte), with pharmacist resources being focussed on direct patient care (particularly admissions and discharges). Despite this, the MI pharmacist has successfully completed the training of pre-registration pharmacists (a function previously undertaken by the regional MI department at Good Hope Hospital) and pre-registration technicians in accordance with UKMI standards. MI Databank, an electronic system for recording and analysis of medicines information queries and responses, was successfully maintained during The ongoing cost of this system is 400 per annum (assigned to pharmacy department budget). The full roll out of the system within the pharmacy team continues to be impeded by the limited time available for pharmacist training. Limited progress was made in , however priority will be afforded to this training in the coming year, as other imperatives allow. The Trust continues to benefit from having the Micromedex medicines database available within the MI department, for use by the clinical pharmacy teams. 4.8 Clinical trials The pharmacy department continues to support clinical trials involving Investigational Medicinal Products (IMPs), in accordance with ICH-GCP guidelines. During , the pharmacy dispensaries provided support for the 11 studies listed in table 3. One of these studies (embolded in the table) was commenced during Four further studies are currently in the pipeline, to commence recruitment in In addition, the aseptic unit had input into 27 chemotherapy studies, seven of which were new in Of these, 16 are open for recruitment and treatment at this Trust with a further five open for recruitment here but for treatment at UHCW. All members of the pharmacy team who are involved in the management of clinical trials have up to date training in ICH-GCP regards the pharmacy aspects of clinical trials. One pharmacist completed refresher training in All others will require refresher training in PEM/Medicines Management Annual Report to the Trust Board /

16 Table 3: Clinical trials Study name Study drug(s) Investigator 1 Leader Liraglutide Dr P Saravanan 2 Aspect Esomeprazole +/- aspirin Dr S Raman 3 BMS Metformin Metformin Dr P Saravanan XR/IR 4 Fourier AMG 145 (Evolocumab) + Dr P Saravanan Statin (patient s usual statin or Atorvastatin) 5 MK MK-3102 (DPP-4 Inhibitor) Dr P Saravanan 6 Devote Insulin Degludec versus Dr P Saravanan Insulin Glargine +/- Insulin Aspart 7 Compass Rivaroxaban +/- Aspirin +/- Dr A Venkataraman Pantoprazole 8 Add-Aspirin Aspirin Dr Chan 9 MK MK-3102 (DPP-4 Inhibitor) Dr Saravanan 10 TAILoR Telmisartan Dr David 11 Ease 2 Empagliflozin Dr Saravanan 4.9 Pharmacy computer systems and robot The pharmacy department operates a JAC Pharmacy computer system, which manages procurement, supply, dispensing and reporting on medicines usage. In the main pharmacy, the JAC system is linked with a Mach-4 Medimat with Speedbox robot, which picks products for dispensing and for ward stock replenishment. The JAC system is currently version 5.1, however there is an IT-led project to replace the current Windows servers (which has a software version which is no longer supported) with new servers. As part of this project, the pharmacy will adopt JAC version No significant impact on the pharmacy team is anticipated, however, as the majority of changes in v2014 relate to the JAC Prescribing System not used at GEH. The Trust continued to use its in-house developed computer system for production of electronic discharge summaries (EDS) during The option to select printers for the pharmacy copies of the EDS, to facilitate ward-based dispensing, remains outstanding for development. This is recorded as a risk on the Trust s risk register. This issue has been highlighted to the new Associate Director of IT. The Trust, via the Chief Pharmacist, has been an active member of the Lorenzo IPPMA user group, as the Trust considers whether (or not) to adopt Lorenzo IPPMA as its preferred electronic prescribing solution. Sheffield are now most advanced in progressing towards golive with Lorenzo IPPMA phase 1, but had not gone live by the end of March 2016, owing to a number of critical issues with the software. The Trust awaits the eventual outcome of this deployment with interest, to inform its own decision regards Lorenzo IPPMA. The TMS insight prescription tracking system was used throughout , to enable turnaround times for prescriptions to be monitored and reported. 16 PEM/Medicines Management Annual Report to the Trust Board /

17 Figure 4: From June 2015 onwards, pharmacist cover in the satellite dispensary was maintained using locum pharmacists as a result of a sequence of substantive pharmacist vacancies following the departure of the substantive band 6 pharmacist and the subsequent pharmacy reorganisation. A high level of service was maintained however, with over 95% of prescriptions being completed within 30 minutes for most of the year with a slight dip from January 2016 following the introduction of a new locum pharmacist (figure 4). The average turnaround time for an outpatient prescription form (i.e. ALL items together) for was 17 minutes. Figure 5 shows that over 95% of discharge prescriptions clinically checked on the ward were consistently processed within 2 hours during The average turnaround time was 51 minutes. Figure 5 For discharge prescriptions not clinically checked on the ward (i.e where the clinical check AND dispensing is completed in the dispensary), 80% were consistently processed within two hours of presentation (Figure 6). Performance fell below this level in May 2015 and July 2015 as a result of staff vacancies compounded by sickness absence. The average turnaround time for this group of TTOs was 77 minutes. As 76% of all TTOs are clinically checked on wards, the average turnaround time for ALL TTOs was 57 minutes. 17 PEM/Medicines Management Annual Report to the Trust Board /

18 Figure 6 The pharmacy department continues to use Powergate e-commerce software to electronically send orders for medicines, exported from the JAC system, to the appropriate supplier using electronic data interchange, a point-to-point protocol (with major wholesalers) or e-fax. Some suppliers, most notably wholesalers, send invoices through the same system, which are processed electronically by the JAC system without the need for all data to be manually entered. Electronic ordering and invoicing is now highlighted as best practice in the Carter report. The Trust is already delivering on this element Dispensing errors All dispensing errors which are not detected and corrected by the final pharmacy check and so leave the pharmacy department are recorded and investigated. The number of such dispensing errors identified in was 20 per 100,000 items dispensed, 11 of which were serious errors, involving incorrect drug, strength, form or directions for use (Figure 7). The national benchmark for such serious errors is 18 per 100,000, so the department is not a negative outlier, however the pharmacy team continue to look for ways to further reduce their dispensing error rate, including monitoring detected errors and providing constructive feedback to dispensing staff. Figure 7: Annual dispensing error rate 18 PEM/Medicines Management Annual Report to the Trust Board /

19 4.11 Pharmacy temperature monitoring system The Comark integrated pharmacy temperature monitoring system was used throughout to monitor medicines storage temperatures (ambient and refrigerator) in the main and satellite pharmacies. Temperatures which fall outside the pre-determined range for the area being monitored (2-8C for refrigerators, less than 25C for room temperature storage) generate alerts which are ed to the senior technicians and (out-of-hours) texted to the out-of-hours pharmacist. Reports from the system allow the ongoing storage temperature of medicines in the pharmacy department to be assured. No room temperature excursions above 26C were encountered during Excursions in refrigerator temperatures were invariably short lived, related to the fridge being accessed. Excursions were responded to promptly, when identified Routine financial reporting The pharmacy department continues to provide electronic and hard copy data to the finance department, for subsequent circulation to the CBUs. The finance team use the data supplied to identify expenditure on medicines by each cost centre, and to identify and retrieve savings realised as a result of medicines CIP initiatives. In addition, patient-specific medicine usage data is used to recover payments for PBR-excluded drugs from commissioners. Data on expenditure on the top 10 highest spend drugs for each cost centre assists directorates in identifying changes in prescribing patterns promptly, so that appropriate investigation and remedial action can be taken where necessary, with the support of the pharmacy team. Pharmacy input into the Clinical Business Units is currently ad-hoc and reactive. Investment in the pharmacy team will be required, to enable a pro-active approach to be adopted, which would include regular input into CBU management meetings by a CBU pharmacist to advise on savings opportunities and areas of concern regards prescribing. This will be incorporated into the Hospital Pharmacy Transformation Programme, highlighted earlier (section 3) Pharmacy service improvement initiatives A number of service improvement initiatives were sustained during , particularly focussed on expediting the discharge of hospital inpatients. Seven-day working, as part of normal staff rotas, was continued during to enable discharge medicines to be provided seven days a week, so as to expedite patients leaving hospital once they become fit for discharge. The previous Saturday provision was incorporated into the new scheme, so that now, both Saturday and Sunday working are incorporated into normal rotas. Figure 8 shows the number of patients discharge prescriptions processed on Sundays during On average, 15 patients discharge medicines are processed each Sunday, demonstrating the benefits of this service in enhancing the availability of beds within the Trust 19 PEM/Medicines Management Annual Report to the Trust Board /

20 Figure 8: Number of pat ient s TTO s pr ocessed on Sundays The ward-based processing of discharge prescriptions by the pharmacy team was continued during , with three pharmacy teams (usually comprising one pharmacist and one technician per team) providing a ward-based discharge service to groups of 3-4 wards in the afternoons. This allows the technician to check with the patient whether they already have a supply of pre-admission medicines, either with them in hospital or at home, to avoid unnecessary resupply. This avoids putting the patient at risk of taking a double dose (by inadvertently taking their own medicines AND new medicines supplied by the hospital) and avoids the cost of re-supply. The pharmacist checks the discharge prescription against the inpatient medicine chart, also on the ward, to ensure there are no transcription errors or omissions by the prescriber. Any concerns identified are discussed directly with the doctor or patient on the ward, avoiding the need for phone calls (as would be the case for the dispensary-based service). During , owing to staffing constraints (sickness, turnover, maternity leave), the ward based teams were frequently operating without technician support, reducing their efficiency. It is anticipated that this will improve during as the technician team is restored. 5. Financial performance The pharmacy department delivered its service in budget for and delivered 230K medicines cost improvement programme, via a range of initiatives, agreed with the Medical Director and Director of Nursing, which did not adversely impact on patient care. The initiatives included securing discounted prices for medicines, savings from changing the choice of medicine from a group (e.g. biosimilar filgrastim) and changes to medicines management procedures (e.g. increasing use of patients own medicines). 6. Antimicrobial Prescribing The prudent management and audit of antimicrobial drugs within the Trust has been sustained during with the support of the antimicrobial pharmacists. The Trust s antibiotic treatment guidelines were revised and approved by DTC in March 2015 and subsequently issued in May The Trust s Clostridium difficile management guidelines were updated and approved in March Copies of all current antimicrobial guidelines & policies are available on the Pharmacy Guidelines website on the Trust s intranet, which has a direct link from the intranet homepage. 20 PEM/Medicines Management Annual Report to the Trust Board /

21 The Trust s Antimicrobial Stewardship Group, met three times in , the latest meeting being held on Dr Sam George, Consultant Anaesthetist, agreed to chair the group from December Terms of reference and a work plan, based on a self assessment completed using a tool produced by the ARHAI, have been agreed. The work plan includes the revision of antimicrobial prophylaxis guidelines and a series of audits. In addition, the ASG approved the Trust s response to NHS/PSA/Re/2015/007 on Antimicrobial Stewardship, developed an action plan for implementation of NICE NG15 (antimicrobial stewardship) and worked on a revised inpatient medicine chart which includes a highlighted prompt for review of antibiotics after up to 72 hours of initiation (as required by the national CQUIN on antimicrobial stewardship for ). The monitoring of compliance with the Trust s antimicrobial policy by the antibiotic pharmacists, which requires all prescriptions for antibiotics to state the indication and duration of treatment, was monitored monthly during (Figures 9 & 10). Figure 9: Compliance with DURATION of course on prescription chart Figure 10: Compliance with INDICATION for antibiotic on prescription chart 21 PEM/Medicines Management Annual Report to the Trust Board /

22 The results showed a sustained moderate level of compliance with documentation of indication (65-95%) and duration(70-95%). The target remains at 100% compliance, which may only be achieved following deployment of electronic prescribing. The importance of compliance with the antibiotic prescribing policy continued to be emphasised to junior medical staff during induction and to consultants at their mandatory update, at Divisional meetings and at DARE multidisciplinary audit days The use of broad spectrum antibiotics, particularly those associated with the development of Clostridium difficile infection, is monitored monthly by the antibiotic pharmacists and reported monthly to IPACC. Usage data derived from the pharmacy issues records is converted to WHO Defined Daily Doses (DDDs) and presented graphically (figures 11-14). The continued low usage of quinolones and cephalosporins was noted throughout , though an upward trend in the use of ciprofloxacin is apparent, following the publication of prescribing guidelines in May 2015 advocating its use in patients with severe penicillin allergy. The relatively high use of co-amoxiclav reflects its use as an alternative to quinolones and cephalosporins. The IPACC continues to monitor this usage in association with any changes in the incidence of C difficile. The number of patients identified with C difficile infection remained low during , with only 10 reportable post-72 hour cases being identified, five of which were considered to be unavoidable. Figure 11: Use of cephalosporins for inpatients and for patients on discharge Figure 12: Use of ciprofloxacin for inpatients and for patients on discharge 22 PEM/Medicines Management Annual Report to the Trust Board /

23 Figure 13: Use of broad spectrum penicillins for inpatients and for patients on discharge Carbapenem usage increased during reflecting their use as an alternatives to penicillin in patients with mild penicillin allergy, the emergence of extended spectrum betalactamase-producing organisms (ESBLs) and the growth in activity in the Ambulatory Care Unit, where ertapenem is a useful once-daily broad spectrum agent (Figure 14). Figure 14: Use of carbapenems for inpatients and patients on discharge For , a national CQUIN has been issued, requiring provider trusts to reduce their use of carbapenems by 1%, relative to usage. Given the change in use between and the present, this represents a 15% reduction in use from Given that the alternatives to carbapenems are very costly (e.g. fosfomycin) or associated with C difficile (e.g. quinolones and cephalosporins), it is currently unclear how this CQUIN will be delivered. The Trust s Antimicrobial Stewardship Group has reaffirmed that the safe and effective management of patients (i.e. avoiding medicines which may predispose the patient to C difficile infection) must remain the paramount consideration. As most wards carry stocks of antibiotics, it is NOT currently possible to assign each DOSE to an individual patient, from the data currently available. The presented data reflects the number of doses supplied to the clinical area, rather than the number administered, and is therefore skewed by changes in ward stock holding. This is the reason for the peaks in usage around some bank holidays, as wards stock up. 23 PEM/Medicines Management Annual Report to the Trust Board /

24 Accurate administration data would be available with the introduction of inpatient electronic prescribing (see section 13 below). In addition to recording every dose administered to each patient, electronic prescribing would absolutely restrict the prescribing of some antibiotics to consultants only. 7. Medicines-related incidents Staff continued to report medicines-related incidents via the Datix incident reporting system during The number of reported incidents per month varied from 29 to 62 with an average of 48 incidents per month in % of incidents were classified as no harm whilst 11.4% were designated low harm, 9.7% as moderate harm and 0.2% (1 incident) as severe harm. The latter involved a patient with sepsis who did not receive antibiotics in a timely manner. The apparent increase in the number of medicines-related incidents associated with moderate harm corresponded with the introduction of the Datix incident reporting system. The difference may represent a change in the way harm is assessed and presented on Datix, compared to the previous Prism system, rather than a real change in severity. The MMG reviewed a series of incidents classified as moderate harm on Datix and identified that many were actually low harm or no harm but had the potential to cause moderate harm. For the purpose of the Datix report, actual harm should be recorded. For , the MSO will review the harm classification of all medicines-related incidents to ensure that they consistently represent actual harm. This will improve the quality of the data presented within the Trust. An independent report looking at medicines management within the Trust, prepared by the Head of Governance, was presented to the Quality Assurance Committee in February The report highlighted concerns regards the number of reported medicines-related incidents associated with harm. A series of recommendations for action were included in the report. One of the report s recommendations was to reduce the number of medicines-related incidents associated with moderate or severe harm by 20% (from the baseline level in ). The Medicines Management Group has agreed a comprehensive action plan to deliver this outcome. Progress with the action plan is reviewed regularly by the QAC. Figure 15: Number and severity of medicines-related incidents reported Datix introduced In March 2016, following reorganisation within the pharmacy team, a substantive Medication Safety Officer was appointed, taking over from the Chief Pharmacist who was nominated as 24 PEM/Medicines Management Annual Report to the Trust Board /

25 interim MSO in September The new post-holder will support staff in reporting medicines-related incidents, support investigators to identify root causes of incidents and support the dissemination of learning from incidents. The work of the new MSO will support the achievement of the 20% reduction in medicines-related incidents associated with moderate to severe harm. Nationally, the most recent validated data from the NRLS is for the 6 months from 1 st April 2015 to 30 th September 2015, which shows that the rate of reporting of medicines-related incidents at this Trust fell from 6.53 incidents per 1000 bed days in the same period of 2014 to 4.26 incidents per 1000 bed days in (figure 16). The high level of reporting in early 2014 reflects the Trust s acute response to the CQC visit in April The latest reported level of reporting puts the trust 58 th out of 139 acute trusts regards the number of medicines-related incidents reported. This keeps the Trust in the upper half of all acute (nonspecialist) Trusts (n=137) with regards to medicines-related incident reporting, suggesting the healthy reporting culture within the organisation continues. The newly appointed Medication Safety Officer will further promote the reporting of medicines-related incidents resulting in no- or low harm Figure 16 Benchmarking data from NRLS George Eliot Whilst a high level of reporting of no-harm and low-harm incidents reflects a positive culture within the Trust, it is imperative that such incidents are appropriately investigated, so as to enable learning to be derived and disseminated. The new MSO will actively promote the reporting, investigation and dissemination of learning from medicines-related incidents. A report on medicines-related incidents is included in the Director of Nursing s monthly quality report to the Quality Assurance Committee. This report also includes a review of the most frequently encountered incident types: missed doses, administration errors, prescribing errors & omissions and incidents involving discharge medicines. Figures show the trends in these common error types. No sustained trends are apparent. 25 PEM/Medicines Management Annual Report to the Trust Board /

26 Figure 17: Incidents involving missed doses Figure 18: Incidents involving other administration errors Figure 19: Incidents involving prescribing errors and omissions 26 PEM/Medicines Management Annual Report to the Trust Board /