Community Pharmacy Safety in Practice Warfarin Change Package 2017

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Cleopatra Holt
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1 Community Pharmacy Safety in Practice Warfarin Change Package

2 Community Pharmacy Safety in Practice Community Pharmacy Safety in Practice 2017/2018 is a pilot programme. We want to make it suit your needs. We welcome your feedback regarding the programme, learning sessions, ease of use of the materials and resources, and what can be improved for the programme going forward. Please send questions or feedback regarding Safety in Practice to Sarah Young, Sarah.Young2@Waitematadhb.govt.nz, mobile , phone x Warfarin Change Package Background A key aim of the Safety in Practice programme is to reduce the harm experienced by patients from medication use. Adverse drug events (ADEs) and adverse drug reactions are major causes of patient morbidity and mortality, and a source of significant costs for both organisations and patients 1. In a journal article from NZMJ this year, Medication-related patient harm in New Zealand hospitals, warfarin was noted to be the top 10 medicine causing harm, predominantly due to bleeding. Warfarin was attributed to 1.8% of harm documented in this study 1. Based on exploratory analysis into administrative data for 9,000 local hospital admissions, 9% of all potential adverse drug events (ADE) detected were anticoagulant related 2. This change package focuses on the safe use of warfarin, for example: o Effective patient education o Ensuring patient understanding of alarm symptoms to report to a healthcare professional o Consistent documentation of patient education and interventions to evidence work conducted 2

3 NSAID Change Package Aim Aim: All patients prescribed warfarin will receive appropriate warfarin counselling on collection of their medicine. Measuring Reliability of Your Care Pharmacist Scope of Practice 5 The practice of pharmacy is necessarily broad and is wider than pharmacists working directly with patients, given that such roles influence clinical practice and public safety. In a clinical role, the pharmacist acts as a medicines manager, providing patient-centred medication therapy management, health improvement and disease prevention services, usually in a collaborative environment. Pharmacists ensure safe and quality use of medicines and optimise health outcomes by contributing to patient assessment and to the selection, prescribing, monitoring and evaluation of medicine therapy 5. Good medicines management and patient education are core responsibilities of pharmacists, and in conjunction with a Pharmacy Expert Group, we have developed process and patient outcome measures that we believe represent best practice for warfarin management and education, in a succinct manner. These measures indicate expectations of best practice for every patient, every time, for those taking warfarin. It is important and best practice to document all interventions and recommendations made to evidence work that has been carried out. This is one way pharmacists can show all the work that they do, in line with Pharmacy Council of New Zealand Competence Standard O Therefore, the process measures relate to documented evidence that the best practice activities have been performed. Competence Standard O1.4.7 Supports and provides continuity of care with accurate and timely documentation of clinical and professional interventions and recommendations, using agreed handover protocols. 3

4 Process and Patient Outcome Measures Please see Table 1: Measures and Rationale below for further guidance regarding these measures. Please note: these questions relate to the patient or carer as applicable. Part 1: Warfarin Process Measures Questions 1 5 relate to whether there is documented evidence of these activities. Question 6 is a review of questions Have you checked whether the patient knows their target INR and current warfarin dose? 2. Has the patient been informed about what to do if they miss a warfarin dose? 3. Has the patient been informed about potential side effects and what to report? 4. Has the patient been informed about interactions with medicines (prescription, OTC and complementary), supplements, and the effects of food and alcohol? 5. Has the patient been offered written warfarin information? 6. Have all the measures been met? Part 2: Warfarin Patient Outcome Measures Questions 7 9 are patient questions to assess patient outcomes via follow up eg phone call. 1. Could the patient recall that a staff member told them about side effects of warfarin? 2. Could the patient identify at least one of the common side effects of warfarin? 3. Could the patient identify at least one appropriate person to ask for help about their medicines or side effects? 4

5 Data Collection Instructions In order to assess your processes for warfarin management and patient education, we require data from 10 patients taking warfarin to be collected every month. The process measure questions assess whether there is documented evidence of the measures. Data Collection Steps Please refer to the Toniq or LOTS screenshots in the appendix, for more guidance in selecting patients. 1. Identify all patients who were dispensed warfarin in the previous calendar month. 2. Randomly select 10 patients from the identified list. 3. On reviewing the patient records, complete the data collection table for compliance with the measures. Documented evidence is required for questions 1-5. Questions 7-9 are patient outcome measures and require patient follow up eg by phone call. If you are unable to locate a patient phone number for one of the 10 sample patients, please note this in the data collection spreadsheet. 4. Complete the data collection sheet and submit to sarah.young2@waitematadhb.govt.nz by the 15 th of the month. 5. Discuss the results as a team and look for opportunities for improvement. 6. Plan and test change(s) using PDSA cycles. 7. Repeat data collection and submission process each month. Please note: we expect very low scores for the baseline September data, where interactions occurred prior to the Safety in Practice programme beginning, so do not worry about this. 5

6 Measures and Rationale Please note: these questions relate to the patient or carer as applicable. # Measure Rationale 1. Have you checked whether the patient knows their target INR and current warfarin dose? There is good evidence that improved patient knowledge and understanding of the use of warfarin improves anticoagulation control. 3,4,5 2. Has the patient been informed about what to do if they miss a warfarin dose? Refer to Warfarin Red Book page 28 or other suitable source. Warfarin Treatment Booklet "Red Book" available free from Medidata, phone (09) Has the patient been informed about potential side effects and what to report? Bleeding can occur when the INR is between 2 and 3, but is more likely with higher INRs. Tell the patient about the following symptoms to report immediately to a health care professional: Red or brown urine Red or black stools Severe headache Unusual weakness Excessive menstrual bleeding Prolonged bleeding from gums or nose Dizziness, trouble breathing or chest pain Unusual pain, swelling or bruising Dark, purplish or mottled fingers or toes Vomiting or coughing up blood Symptoms of under-coagulation like the following may signal a life threatening situation: Bluish toes/fingers Chest/severe back pain Blurred vision Symptoms of DVT Important: Refer any patient with any presenting symptom(s) to their GP or directly to A&E; especially bleeding or unexplained bruising. 6

7 4. Has the patient been informed about interactions with medicines (prescription, OTC and complementary), supplements, and the effects of food and alcohol? 72.htm Advise patient about the various products that can interact with warfarin. Advise the patient to check with their doctor or pharmacist before making any lifestyle changes. Eg before starting or stopping any other medicines, including OTC, herbal, or complementary medicines, and any big changes in diet. Warn about increased bleeding risk with aspirin and NSAIDs. 5. Has the patient been offered written warfarin information (eg warfarin red book or warfarin patient information)? Offered written information means: The patient/carer has been actively asked if they would like to receive written information. Examples of warfarin information: Warfarin Treatment Booklet "Red Book" available free from Medidata, phone (09) SafeRx Warfarin guides available in English, Chinese, Tongan, Samoan, Niuean, Korean 6. Have all the measures been met? Data collection question For all measures to be met, Yes must be ticked for all questions 1 5 7

8 Patient Outcomes For this section, you need to check the patient or carer s understanding eg via follow up phone call. If you are unable to locate a patient phone number for one of the 10 sample patients, please note this in the data collection spreadsheet. 7. Could the patient recall that a staff member told them about side effects of warfarin? Yes, completely Yes, to some extent No N/A Ask the patient/carer: Did a staff member tell you about warfarin side effects to watch for? Answer guidance: Yes, completely - if the patient could definitely recall the staff member discussing this with them Yes, to some extent - if the patient could partially recall the staff member discussing with them No - if the patient didn t remember the staff member discussing with them N/A - if it wasn t applicable for that particular situation/dispensing eg repeats for someone who is very familiar or has this medicine dispensed frequently 8. Could the patient identify at least one of the common side effects of warfarin? Yes, completely Ask the patient/carer: What are the warfarin side effects to watch out for? This question is to assess whether the education provided to the patient was effective. Yes, to some extent No Answer guidance: Yes, completely - if the patient could identify more than one common side effect Yes, to some extent - if the patient could identify one common side effect or information wasn t completely clear No - if the patient couldn t name any side effects 8

9 9. Could the patient identify at least one appropriate person to ask for help regarding their medicines or side effects? Ask the patient/carer: Who can you ask for help if you are worried about your medicines or side effects? Answer guidance: Yes, completely - if the patient could identify at least one appropriate person to ask for help No - if the patient couldn t name any or if information was unclear Appropriate answers may include examples such as: - Pharmacist - Pharmacy staff - Doctor - Nurse 9

10 Initial Things to Consider - What is the current process for patient education? - How will you select the 10 patients to collect data on each month? (see Toniq / LOTS screenshots attached for more guidance) - How will you document warfarin patient education has taken place? - How will you document warfarin discussions with prescribers? - Who will be responsible for completing the data collection sheet each month? - Who will be responsible for submitting the completed data each month? - Meet with local GPs to discuss the Safety in Practice programme with focus on warfarin - Send letter to GPs regarding Safety in Practice programme with focus on warfarin - Change Ideas to Consider - Discuss results of baseline warfarin data collection at a team meeting - Arrange education session for pharmacy team about warfarin and patient education - Trial example pharmacy checklist for warfarin education - Create warfarin prompt card for education points - Optimise use of Self Care Cards - Utilise SafeRx patient information leaflet - Arrange education session for pharmacy team about atrial fibrillation - Provide information to patients/carers about their reason for being on warfarin eg information on atrial fibrillation, or DVT/PE - Develop a patient evaluation tool, to determine patient s understanding immediately after providing education, then 1 week later, in order to assess effectiveness of education provided Please send questions or feedback regarding Safety in Practice to Sarah Young, Sarah.Young2@Waitematadhb.govt.nz, mobile , phone x

11 Resources o o o o o o o Health Pathways information regarding Warfarin Waitemata DHB Warfarin Counselling Checklist and List of Interactions (included in pack) CounsellingChecklistListofInteractionsMay13.pdf BPAC Guidelines: INR for Monitoring Warfarin Treatment New Zealand Formulary: Warfarin Health Pathways information about Atrial Fibrillation (includes patient information) SafeRx leaflets for warfarin are available in English, Chinese, Korean, Niuean, Samoan and Tongan BPAC article: An update on antithrombotic medicines Additional Information Usual Indications and Duration of Warfarin Therapy Reference: GP Safety in Practice Warfarin Care Bundle 2017 INDICATION TARGET DURATION INR DVT or PE due to reversible risk months factors DVT or PE due to two 2-3 Lifetime unprovoked causes or cancer Chronic AF 2-3 Lifetime Mechanical aortic valve 2-3 Lifetime Antiphospholipid syndrome 2-3 Lifetime without recurrent VTE Mechanical mitral valve Lifetime Mechanical aortic or mitral Lifetime valve with additional risk factors for VTE Antiphospholipid syndrome with recurrent VTE Lifetime 11

12 Medicines that can increase the risk of bleeding include 6 : o Anticoagulants and Antiplatelets eg aspirin, prasugrel, rivaroxaban, abciximab, clopidogrel, dabigatran, dipyridamole, low molecular weight heparin (enoxaparin), tirofiban, heparin o Non Steroidal Anti Inflammatory Drugs (NSAIDs) eg ibuprofen, naproxen, diclofenac o Antithrombotic Agents eg tenecteplase, alteplase Note: A change in risk of bleeding may not be reflected in the INR (eg aspirin increases the risk of bleeding however does not affect the INR) 6. References 1. Robb, G, Loe E, Maharaj A et al. Medication-related patient harm in New Zealand hospitals. New Zealand Medical Journal 2017;130(1460): (Accessed ) 2. Ng, J (2017), Personal communication: Potential Adverse Drug Events identified from administrative data. Auckland, Institute for Improvement and Innovation, Waitemata District Health Board. 3. Tang EO, Lai CS, Lee KK, Wong RS, Cheng G, Chan TY. Relationship between patients' warfarin knowledge and anticoagulation control. Ann Pharmacother Jan; 37(1): Nochowitz B, Shapiro NL, Nutescu EA, Cavallari LH. A structured teaching and self-management program for patients receiving oral anticoagulation: a randomized controlled trial. Working Group for the Study of Patient Self-Management of Oral Anticoagulation.Ann Pharmacother Jul; 43(7): Epub 2009 Jun Sawicki PT. Effect of a warfarin adherence aid on anticoagulation control in an inner-city anticoagulation clinic population. JAMA Jan 13;281(2): Waitemata DHB Warfarin Counselling Checklist and List of Interactions (included in pack) CounsellingChecklistListofInteractionsMay13.pdf 12

13 EXAMPLE WARFARIN CHANGE PACKAGE DATA COLLECTION TABLE Pharmacy Name Review Month Date Patient Have you checked whether the patient knows their target INR range and current warfarin dose? Has the patient been informed about what to do if they miss a warfarin dose? Has the patient been informed about potential side effects and what to report? Has the patient been informed about interactions with medicines, supplements, and the effects of food and alcohol? Has the patient been offered written warfarin information? Have all the measures been met? 1 Y N Y N Y N Y N Y N Y N 2 Y N Y N Y N Y N Y N Y N 3 Y N Y N Y N Y N Y N Y N 4 Y N Y N Y N Y N Y N Y N 5 Y N Y N Y N Y N Y N Y N 6 Y N Y N Y N Y N Y N Y N 7 Y N Y N Y N Y N Y N Y N 8 Y N Y N Y N Y N Y N Y N 9 Y N Y N Y N Y N Y N Y N 10 Y N Y N Y N Y N Y N Y N TOTAL Comments: 13

14 EXAMPLE CHECKLIST Community Pharmacy Safety in Practice Warfarin Checklist Patient NHI/Name Date 1. Have you checked whether the patient knows their target INR range and current warfarin dose? 2. Has the patient been informed about what to do if they miss a warfarin dose? 3. Has the patient been informed about potential side effects and what to report? Patient Education Symptoms of over-coagulation (e.g. excessive bruising, epistaxis, bleeding gums, severe headache, haematuria, haemoptysis, melaena, excessive menstrual bleeding, etc) Symptoms of under-coagulation (bluish toes/fingers, chest/severe back pain, blurred vision or symptoms of DVT etc) may signal a life threatening situation. Important: Refer any patient with any presenting symptom(s) to their GP or directly to A&E; especially bleeding or unexplained bruising. 4. Has the patient been informed about interactions with medicines (prescription, OTC and complementary), supplements, and the effects of food and alcohol? 5. Has the patient been offered written warfarin information (warfarin red book or warfarin patient information)? 6. Have all the measures been met? Q Outcome measures Questions 7 9 are patient questions to assess patient outcomes. 7. Could the patient recall that a staff member told them about side effects of warfarin? Yes, completely Yes, to some extent No N/A 8. Could the patient identify at least one common warfarin side effect? Yes, completely Yes, to some extent No 9. Could the patient identify at least one appropriate person to ask for help regarding their medicines or side effects? 14

Direct Oral Anticoagulant (DOAC)Therapy. Important information for patients prescribed: Apixaban, Dabigatran, Edoxaban or Rivaroxaban

Direct Oral Anticoagulant (DOAC)Therapy Important information for patients prescribed: Apixaban, Dabigatran, Edoxaban or Rivaroxaban Patient Name: Address: Postcode: CHI Number: Condition requiring treatment: