South West Competency Guide to the Dispensing and Checking of Oral Chemotherapy Bristol Royal Infirmary Marlborough Street BRISTOL BS2 8HW Tel. 0117 342 3543 Email: SWPharmacy.Training@UHBristol.nhs.uk 1
Index Summary 3 How to complete the framework 3-4 Glossary (from Skill for Health) 5-6 Undertaking an in-process accuracy check of assembled prescribed items prior to the final accuracy check (SKF Pharm 27) 7-8 Undertake the final accuracy check of dispensed medicines and products (SKF Pharm 28) 9-11 Verifying prescription for chemotherapy against a protocol (SKF Pharm 56 & BOPA SACT FINAL 8.1.10) 12-15 Competency Based framework Feedback Form (to be photocopied for each assessment) 16 Register of persons validated to perform tasks (example) 17 Notes Page 18 Competency framework Management 19 Comment and Feedback page 20 2
Summary This competency guide has been developed in response to the National Chemotherapy Advisory Group (NCAG) 2009 Report 1 along with the National Patient Safety Agency (NPSA) Rapid Response Report, risks of incorrect dosing of oral anti-cancer medicines, January 2008 2. A key recommendation: The NCAG 2009 report recommends that, Prescribing, prescription verification and dispensing of chemotherapy should only be undertaken by appropriately trained staff. All chemotherapy services should maintain up to date lists of staff that are designated to prescribe (either first or subsequent cycles), check prescriptions and dispense chemotherapy. Protocols should be agreed across a Cancer Network, incorporated into a protocol book (actual or web-based) and updated at least annually. The competencies within this guide have been assembled to action the above recommendation. The competencies have been taken from both the Skills for Health National Occupational Standards (www.skillsforhealth.org.uk) and the Standards for Clinical Pharmacy Verification of Prescriptions for Cancer Medicines, developed by the British Oncology Pharmacy Association (BOPA) 3. The National Occupational Standard (SKF PHARM 56) verifying prescription for chemotherapy against a protocol has been combined with the BOPA standards. Completing the assessment Before a trainee commences the competency based assessment, Standard Operating Procedures must be in place covering functions within the assessment In-house training must be available for the trainee undertaking the assessment. Knowledge indicators are available on the Skills for Health to help with training. The trainee must be aware of local and national guidance and documentation The trainee must be assigned a mentor to guide them through the assessment process 3
Completing the assessment The competency based framework is designed to be used once a trainee and their assigned mentor are confident that the trainee has been trained sufficiently within a given area and has gained appropriate knowledge, skills, experience and confidence. To complete the assessment the trainee should Familiarise themselves with the competencies they will be assessed against. Be assessed with real patients. The assessments must be performed objectively on performance/competence assessed against the set standards. After each assessment constructive feedback must be provided and documented by the mentor. To become accredited the trainee must complete five satisfactory assessments. Where a competency point has several components (i.e. a) b) c) d)), each component must be completed to fulfil the competency. It is important that there should be clear guidance on how the candidate can access an appropriate person for support, guidance and further information. Standard Operating Procedures It is recognised that there are differences in chemotherapy services and individuals roles within the service. If some of the competencies are not a part of an individual s role, the organisation should have a policy in place clearly identifying who is responsible for the outstanding role and how information is documented 3. 1. National Chemotherapy Advisory Group. 2009. Chemotherapy Services England: Ensuring Quality & Safety 2. National Patient Safety Agency. 2008. Rapid Response Report, risks of incorrect dosing of oral anti-cancer medicines 3. British Oncology Pharmacy Association.2010. Standards for Clinical Pharmacy Verification of Prescriptions for Cancer Medicines 4
Glossary of Terms from Skill for Health (pharm 27, pharm 28, pharm 56) Clinical Check - A clinical check carried out by a prescriber and/or a pharmacist. This may include performing checks to ensure that the prescription meets the appropriate legal, safety and clinical requirements Chemotherapy - Anti-cancer (cytotoxic) drugs and monoclonal antibodies used to treat cancer Prescription - A document which describes the medication determined by an authorised individual for a named individual. It includes the medication to be used, the dose, dilution, mode of delivery and time period for delivery Dispensing - Includes all of the activities which occur from the time the prescription is received by the pharmacy or a dispensary until the medication or other prescribed item has been collected or transferred to the individual Final Accuracy Check - Is the final accuracy checking process performed on dispensed items by a suitably qualified person immediately prior to the dispensed medicines/products being issued to individuals or their representatives and includes a check that nothing has changed since the last clinical check. Near Miss - A near miss is an error made during the dispensing process which is identified and rectified before the medicine reaches the patient. Standard Operating Procedures (SOPs) - Referred to as SOPs and include written protocols and procedures. They state the way your organisation requires tasks to be carried out to ensure a quality pharmaceutical service is provided at all times Valid - A prescription is considered valid when it is legal and legible. A valid prescription must include any special requirements and meets the requirements as stated in the relevant mandatory guidance Verify - If you verify something, or verify that something is the case, you find out whether it is true. If you verify your findings, you find out whether your findings are supported by the information you have. If you verify a source, you check that a particular source is indeed where information has come from. 5
Appropriate person may include: a) a pharmacist b) a prescriber Fit for purpose may include: a) intact, presentable packaging b) clean, non-contaminated packaging c) within expiry date for course of treatment d) packaging complies with legal requirements e) complies with relevant regulatory requirements Prescribed items may include: a) solid forms (tablets, capsules, pessaries, suppositories) b) liquid forms (oral, topical, injectable) c) preparations to be taken internally d) preparations to be used externally e) original packs f) cytotoxic drugs g) medical devices h) appliances i) controlled drugs Suitably qualified person may include: a) a pharmacist b) a prescriber c) a registered pharmacy technician Appropriate sources may include: a) professional colleagues b) written materials c) electronic information Individual data may include: a) age b) height c) weight d) clinical investigation results e) biochemistry results Individual treatment related data may include: a) previous treatment b) number of chemotherapy cycles Prescription May include from: a) general practitioners b) nurse prescribers c) pharmacist prescribers d) doctors from clinics or hospitals e) doctors from drug addiction clinics f) general practitioners for drug addiction g) dentists h) other registered prescribers i) repeat dispensing prescription form 6
South West Medicines Management Competency based assessment criteria for Undertaking an in-process accuracy check of assembled prescribed items prior to the final accuracy check (SKF Pharm 27) Trainee s Name. Assessor's Name. You must always 1. ensure that you work in accordance with current Standard Operating Procedures at all times 2. refer queries at all times to a suitably qualified person 3. ensure that the prescription has had a clinical check and has been assessed as suitable for dispensing by an appropriate person 4. check with the appropriate person to confirm that the prescription is valid 5. check that all prescribed items have been assembled according to instructions (all components a-f must be completed) a) check that the correct item has been dispensed in the correct form and correct strength b) check that the correct quantity has been dispensed or arrangements for further future supply made as indicated on the prescription 7
c) check that the label on the item matches the dispensed product and the prescription requirements including the form and strength d) check that the assembled items are fit for purpose e) check appropriate packaging has been used f) check appropriate selection of medicine devices/sundry items to accompany the medicine or product 6. rectify any dispensing errors in accordance with Standard Operating Procedures 7. annotate and endorse prescription in accordance with Standard Operating Procedures 8. ensure any dispensing errors are recorded in accordance with local policies and guidelines 9. record the date and your details in accordance with Standard Operating Procedures 10. once satisfied with the in-process accuracy in dispensing, pass the dispensed prescription on for a final accuracy check to be undertaken by a suitably qualified person During the assessments, on at least one occasion, a full assessment must be undertaken where ALL competency-based criteria are achieved 8
South West Medicines Management Competency based assessment criteria to undertake the final accuracy check of dispensed medicines and products (SKF Pharm 28) Trainee s Name. Assessor's Name. You must always 1. ensure that you work in accordance with current Standard Operating Procedures at all times 2. refer any queries to an appropriate person 3. ensure that the prescription has had a clinical check by an appropriate person and has been assessed as suitable for dispensing 4.check to confirm that the: (all components a-d must be completed) a) individual or their representative has completed the declaration on the prescription if required b) prescription is valid c) prescription is correctly written in respect of meeting national and local policies and guidelines d) prescription is correctly endorsed 5. perform an accuracy check on each of the dispensed medicines / products 9
(all components a-e must be completed) a) check that the correct item has been dispensed in the correct form and correct strength b) check that the correct quantity has been dispensed or arrangements for further future supply made as indicated on the prescription c) check that the label on the item matches the dispensed product and the prescription requirements including the form and strength d) check that the assembled items are fit for purpose e) check appropriate packaging has been used 6. rectify any dispensing errors in accordance with Standard Operating Procedures using appropriate communication methods 7. ensure that the type of dispensing error is recorded in the correct documentation format in accordance with local policies and guidelines 8. record the date and your details in the dispensary records on the prescription as appropriate 9. ensure that the appropriate medicine devices/sundry items to accompany the medicine or product have been provided 10
10. place medicine or product in the appropriate packaging 11. annotate the prescription appropriately 12. complete the required dispensary records in accordance with Standard Operating Procedures During the assessments, on at least one occasion, a full assessment must be undertaken where ALL competency-based criteria are achieved. 11
South West Medicines Management Competency based assessment criteria for verifying prescription for chemotherapy against a protocol (based on BOPA standards & SKF Pharm 56) Trainee s Name. Assessor's Name. You must always 1. Work within the legislative framework and guidelines in your place of work including SOPs. Understand and advise on local and national policy in context of the use of chemotherapeutic agents. Review evidence to support the use of treatment regime. Ensure the prescription request is complete, appropriate, achievable and verified by the authorised person against agreed protocols including funding approval BOPA 4.1 Check prescribers details and signature are present and confirm they are authorised to prescribe SACT 4.2 Ensure regimen has been through local approval processes e.g. clinical governance and financial approval and/ or is included on a list of locally approved regimens 4.6 Check that the timing of administration is appropriate i.e. interval since last treatment 4.12 Check method of administration is appropriate 12
2. Collate the relevant individual data and individual treatment related data 3. Check individual data and individual treatment related data for validity, consistency, accuracy and completeness BOPA 4.3 On the first cycle check regimen is intended treatment as documented in a treatment plan, in the clinical notes or in the electronic record. 4.4 Check regimen is appropriate for patient s diagnosis, medical history, and performance status and chemotherapy history. 4.7 Check patient demographics (age, height and weight) are correct on prescription. 4.8 Check body surface area (BSA) is correctly calculated, taking into account recent weight. Note there should be local agreement for frequency of monitoring and checking patient weight. 4.9 Check all dose calculations and dose units have been calculated correctly according to the protocol and any other relevant local guidance, e.g. dose rounding/banding 4.13 Check laboratory values FBC, U&E s and LFT s 13
are within accepted limits if appropriate 4.14 Check doses are appropriate with respect to renal and hepatic function and experienced toxicities 4.15 Check other essential tests have been undertaken if appropriate 4. Check drug-drug interactions and drug food interactions BOPA 4.5 Check there are no known drug interactions (including food) or conflicts with patient allergies and other medication(s) 5. Discuss with an appropriate expert the evidence and need for the treatment regime 6. Interpret data and select appropriate methodology according to protocol in order to calculate treatment dose BOPA 4.11 Check reason and consistency of any dose adjustments e.g. reduction(s) or escalations and ensure reason is documented 7. Record all calculations, calculation results and treatment instructions according to protocols 14
BOPA 4.10 Check cumulative dose and maximum individual dose as appropriate. 8. Ensure that supportive medication has been prescribed appropriately BOPA 4.16 Check supportive care is prescribed and is appropriate for patient and regimen 9.Sign and date the prescription in line with Standard Operating Procedures BOPA 4.17 Sign and date prescription as a record of verification 10. Recognise situations where you need to seek advice/ support from appropriate sources and respond appropriately; in particular, where the complexity exceeds your personal level of competence or where there is reason for concern about the individual s suitability for the prescribed treatment 11.Document and record the outcome of any pharmaceutical issues in accordance with Standard Operating Procedures During the assessments, on at least one occasion, a full assessment must be undertaken where ALL competency-based criteria are achieved 15
South West Medicines Management Competency Based Assessment Feedback Form Candidate Name.. Assessment 1 : Assessment 2 : Assessment 3 : Assessment 4 : Assessment 5 : Comments Comments Comments Comments Comments Mentor signature/initials Mentor signature/initials Mentor signature/initials Mentor signature/initials Mentor signature/initials 16
South West Medicines Management Register of persons validated to perform oral chemotherapy tasks: in-process accuracy check/final accuracy check/verifying prescription Name & Job Role In-Process Checking Final Accuracy Check Verifying Prescription Sign & 17
South West Medicines Management Competency Based Assessment Notes Page 18
Management of the Scheme This scheme can be used in its entirety or can be adapted for use within individual departments. It has been assembled from the Skills for Health competencies and the BOPA standards by South West Medicines Information and Training (SWMIT). The competency guide is designed to be used after appropriate training of checking functions, primarily associated with oral chemotherapy medicines has been undertaken. SWMIT will, Ensure the document is available for use on the SWMIT website (www.swmit.nhs.uk) Ensure the document is updated regularly and is in line with current guidance and best practice Provide advice if required and information to hospitals and individuals wishing to implement the competency assessment For more information on this scheme, please contact: Ellen Williams, Regional Education & Training Lead, SWMIT, ellen.williams@nhs.net 0117 342 3487 Trevor Beswick, Director SWMIT, trevor.beswick@uhbristol.nhs.uk 0117 342 2867 19
Comments and Feedback Page Please rate the following aspects of the competency framework Totally Disagree Disagree Agree Totally Agree a) The framework fulfilled the dispensing aspects of the NCAG requirement b) The framework fulfilled the organisation/individuals competency requirements c) The framework was easy to use and implement d) The framework has improved knowledge and skills base within the organisation Further comments: Once completed please return by post or electronically to: Ellen Williams,, Marlborough St, Bristol Royal Infirmary, Bristol, BS2 8HW. ellen.williams@nhs.net 20