Development of Clinical Pharmacy Standards in Oncology Joanne Robinson Senior Pharmacist – Oncology NHS Forth Valley Member of Scottish Oncology Pharmacy Practice Group Spot the Difference Job title : Cancer Care Pharmacist Job title : Cancer Care Pharmacist Spot the Difference Job title : Cancer Care Pharmacist Job title : Cancer Care Pharmacist Based within aseptic services Based on ward/clinic Clinical check of prescription involves: Clinical check of prescription involves: BSA & dose check Check of diagnosis and staging Appropriate administration BSA & dose check Appropriate supportive care FBC, LFT & U&E check Appropriate supportive care Content • Development of Scottish SOP for pharmaceutical care planning • Development of ASTCP capacity plan for cancer • Update to clinical capacity plan • Development of clinical quality standards in oncology Scottish Care Planning Standards • Developed in 2001 • Aim to standardise clinical pharmacy practice in chemotherapy across Scotland – GUIDELINES FOR THE COMPLETION OF PHARMACEUTICAL CARE PLAN FOR CANCER PATIENTS RECEIVING CHEMOTHERAPY – STANDARDISED PHARMACEUTICAL CARE PLAN DOCUMENTATION Elements of PCP • All patients receiving chemotherapy – IV or oral • PMH • Previous treatment for cancer • Current medication • Height, Weight, BSA • Chemotherapy eligibility • Chemotherapy appropriateness – Drugs/doses – Administration • Immunosuppressants • Monitoring Issues • Individual care issues GENERIC PHARMACEUTICAL CARE PLAN : CANCER CARE Surname Date of birth / age Forename Patient number General practitioner Diagnosis: Chemotherapy Regimen: Community Pharmacist RELEVANT MEDICAL HISTORY Approx date Problem description 1 2 3 Known drug sensitivities: Sex Consultant Approx Date 4 5 6 PREVIOUS TREATMENT FOR CANCER Chemotherapy: Date No of cycles 1. 2 3 Radiotherapy: Date No Fractions Ward Problem description Response / toxicities / cumulative doses Response / toxicities Other treatments (including surgery): CONCURRENT MEDICATION: update on each cycle of treatment DATES start stop 1 8 2 9 3 10 4 11 5 12 6 13 7 14 ADR's / OTC medications: DATES start stop Initials / Dates of cycles Height: Weight Surface Area ( m2) Generic Care Issue 1 2 3 Action Output (initial) • Verified • Modified Chemotherapy Eligibility (only complete on first cycle) Chemotherapy Appropriateness Refer to local protocol to verify treatment plan from diagnosis, tumour type and performance status • LP • OLP • CT A: Drugs / doses • • • • • • (Cross if verified B: Administration • • • • • • tick if adjusted) (see monitoring plan for FBC/ CrCl/ LFT's) Immunosuppressive therapy Patients taking concurrent immunosuppressive therapy in addition to chemo Comments/dose reductions: • • • • • • (cross if verified, tick if adjusted) GENERIC PHARMACEUTICAL CARE PLAN : CANCER CARE Monitoring Issues: Cross if no problem, tick if a problem and document in care issues section or annotate N/A if not assessed Nausea and vomiting Mucositis/Mouthcare Neurology Bowel habit • • • • • • • • • • • • • • • • • • • • • • • • Neutropenic Sepsis Skin Toxicity Pain control Insomnia • • • • • • • • • • • • • • • • • • • • • • • • Depression Absorption / distribution Counselling/Education Discharge/ self med issues • • • • • • • • • • • • • • • • • • • • • • • • FBC LFT's / bilirubin Renal function Other: • • • • • • • • • • • • • • • • • • • • • • • • INDIVIDUAL CARE ISSUES Date Care issue Recurring care issues: Action Output (Initial) Care Planning in Practice • Care plan in original format used in majority of units/centres • Some units/centres have kept same elements but adapted for local use Care Planning in Practice • Advantages – Standardises practice – Allows us to define what is meant by clinical verification • Disadvantages – Documentation may duplicate effort – Very few like the ticks and crosses Application of Capacity Plan • Cancer in Scotland – Action for Change published in 2001 – In excess of £50million investment promised – ASTCP took unified approach to secure funding for pharmacy cancer services – Scottish capacity plan for pharmacy services to cancer patients was developed – Scotland-wide bid submitted for cancer pharmacy staffing Success! • > £1 million secured for pharmacy staff • > £1 million secured for pharmacy equipment What was this based on? • Safe staffing levels – Aseptic dispensing – based on items – Dispensing services – based on items – Clinical pharmacy services – based on patient numbers • 1 pharmacist = 20 outpatients per day • 1 pharmacist = 30 inpatients per day • Based on consensus of opinion which was benchmarked against current practice. Limitations of Model • Model did not take into account complexity of workload – Some patient groups require more intensive input eg BMT – Some patients require more patient education eg Capecitabine Update to Capacity Plan - 2007 • Scottish Oncology Pharmacy Practice (SOPPG) and Scottish Aseptic Services Specialist Interest Group (ASSIG) tasked with updating capacity plan • Aseptic capacity plan was updated taking into complexity of preparation and dispensing of dose banded products – Approved by Directors of Pharmacy Group 2008 Update to Clinical Capacity Plan • Incorporate complexity of workload – Inpatients v outpatients – Oncology v haematology • First step was to survey opinion of cancer pharmacists in 19 hospitals across all 3 cancer networks, cancer centres and cancer units Update to Clinical Capacity Plan • Next step – test assumptions – Pharmacists asked to measure the actual time taken for outpatients and inpatients – 9 centres participated • New outpatients 58 • Return outpatients 241 • New inpatients 40 • Return inpatients 88 • Non-chemo inpatients 102 New Model • No difference between oncology and haematology in terms of timings • Still needed different models for outpatients and inpatients • Need to differentiate between routine and complex inpatients Model for Outpatients • Timings – Chemotherapy care planning – cycle 1 • 16 minutes – Chemotherapy care planning – cycle 2 onwards • 12 minutes – Patient education • Simple – 6 minutes • Intermediate – 12 minutes • Complex – 18 minutes Spreadsheets • Devised to work out – How many pharmacists required to care plan a certain number of patients in a certain time period or – The total number of pharmacist hours required to care plan the total number of patients • Takes into account a 15% efficiency factor to account for peaks in workload • Allows for ‘liaison time’ eg phoning, faxing, communication etc Clinical Pharmacy Capacity Planning Spreadsheet Outpatients hours Available time per clinic Minus efficiency factor 7.5 minutes 450 30 Total number of patients at clinic Number of new patients Number of return patients Number of patients counselled Number of patients counselled Number of patients counselled 382.5 352.5 20 2 18 10 2 2 simple intermediate complex Outpatients receiving Chemotherapy New Time taken per patient (mins) Proportion of patients Proportion of time Time per group Number of patients Total number of outpatients able to be seen in allocated clinic time by one pharmacist Number of pharmacists required to cover clinic in cover clinic in allocated time Return 16 10% 9% 31 1.9 Education 12 90% 59% 207 17.2 6 50% 16% 57 9.58 Education Education 12 18 10% 10% 7% 10% 23 34 1.92 1.92 19.2 1.0 Total time required - per patient group New 32 Return 216 Education - simple 60 Education - intermediate 24 Education - complex 36 plus liaison time plus efficiency factor Total 368 398.0 468.235294 Total number of hours of pharmacist time required 7.8 Model for Inpatients • Timings – New admission for chemotherapy – cycle 1 • 20 minutes – New admission for chemotherapy – from cycle 2 • 15 minutes – New admission – no chemo • 11 minutes – Patients from day 2 • 6 minutes – Discharge Planning • 10 minutes – Patient Education • 6, 12, 18 minutes Clinical Pharmacy Capacity Planning Spreadsheet Inpatients hours Available time per ward visit Minus efficiency factor Exclude liaison time minutes 7.5 450 45 Total number of patients in the ward Total new chemo admissions Total return chemo admissions Total non-chemo admissions Total day 2 onwards Number of discharges Number of patients counselled -simple Number of patients counselled - intermed Number of patients counselled - complex 382.5 337.5 30 1 3 1 25 5 5 1 1 Inpatients New chemo Time taken per patient Proportion of patients Proportion of time Time taken per group Number of patients Return chemo 20 3% 6% 20 1.0 15 10% 13% 45 3.0 no chemo 1st day subsequent days 11 3% 3% 11 1.0 Total number of inpatients able to be seen in allocated ward time by one pharmacist Number of pharmacists required to cover ward in allocated time Total time required - patient group New Return no chemo 1st day subsequent days discharge planning Education - simple Education - intermediate Education - complex Total Total number of hours of pharmacist time required 20 45 11 150 50 30 plus liaison time plus efficiency factor 12 18 336 381.0 448.2352941 7.5 6 83% 45% 151 25.1 Discharge planning 10 17% 15% 50 5.0 Education 6 17% 9% 30 5.0 30.1 1.0 Education 12 3% 4% 12 1.0 Education 18 3% 5% 18 1.0 Complex Inpatients • Timings – New admission • 25 minutes – Subsequent days • 15 minutes – Rest as per standard inpatients Next steps • Model was endorsed by the Scottish Directors of Pharmacy Group – Timings to be incorporated into CPORT pilot sites to further validate – Agreement to share model UK wide and work collaboratively with BOPA to develop UK quality standards for cancer pharmacists Applicability to UK • Cancer Action Team – ‘All chemotherapy prescriptions should be checked by an oncology pharmacist, who has undergone specialist training, demonstrated their appropriate competence and is locally authorised/ accredited for the task.’ • NCEPOD report (2008) – “Pharmacists should sign the SACT prescription to indicate that it has been verified and validated for the intended patient and that all the safety checks have been undertaken”. • What does this signature mean? • May mean different things to different people Standardising Clinical Verification • BOPA to consult on the minimum requirements for a pharmacist verification check • Acknowledges there are differences in practice across the UK and therefore there needs to be flexibility in working practice • Some elements may not require to be personally undertaken by the pharmacist as long as there is a documented system in place to ensure that these checks are undertaken Elements of Verification 1 • Check Patients details are correct on prescription • Check prescribers details • Check regimen protocol is appropriate for patient’s diagnosis, medical history and chemotherapy history • Check regimen is the intended regimen • Complete pharmaceutical care plans/ patient record • Check there are no known drug interactions or conflicts with patient allergies • Check body surface area (BSA) is correctly calculated, taking into account most recent weight. Elements of Verification 2 • Check dose calculations and dose units are appropriate according to BSA • Check reason for any dose reduction(s) • Check method of administration is appropriate • Check laboratory values, FBC, U&E and LFTs • Check doses are appropriate with respect to renal and hepatic function and any experienced toxicities • Check other essential laboratory tests have been undertaken • Check supportive care prescribed is appropriate for the patient Next Steps in Scotland • Standard pharmaceutical care plan will be updated Next Steps - BOPA • Consultation on Verification standards • Produce supporting toolkit/ guidance that gives details to inform SOP’s • Work with Scottish Cancer Pharmacy Group to further validate capacity plan • Generic care plan made available for local use or adaptation Advantages • Ensure safe provision of chemotherapy • Standardisation of practice • Tool for improving access to information for pharmacists • Standards of practice allow capacity planning to be undertaken on larger scale – More credibility due to national system • Incorporate into future systems eg CPORT Spot the Difference Job title : Cancer Care Pharmacist Job title : Cancer Care Pharmacist Based within aseptic services Based on ward/clinic Clinical check of prescription involves: Clinical check of prescription involves: BOPA approved verification steps BOPA approved verification steps No Difference!