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1 This document has been developed based on the Scottish Patient Safety Programme Community Pharmacy Safety in Practice Warfarin Change Package 2017

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Page 1: Community Pharmacy Safety in Practice Warfarin …koawatea.co.nz/wp-content/uploads/2017/09/FINAL-Warfarin-Change... · Community Pharmacy Safety in Practice . Warfarin Change Package

1 This document has been developed based on the Scottish Patient Safety Programme

Community Pharmacy Safety in Practice

Warfarin Change Package 2017

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2 This document has been developed based on the Scottish Patient Safety Programme

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, [email protected], mobile 021 537 346, phone 09 486 8920 x 3742.

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 patients1. 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 study1. 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

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3 This document has been developed based on the Scottish Patient Safety Programme

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 Practice5

“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 O1.4.7. 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.”

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4 This document has been developed based on the Scottish Patient Safety Programme

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 1 – 5.

1. 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?

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5 This document has been developed based on the Scottish Patient Safety Programme

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 [email protected] by the

15th 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.

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6 This document has been developed based on the Scottish Patient Safety Programme

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?

Yes □ No □

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?

Yes □ No □

Refer to Warfarin Red Book page 28 or other suitable source.

Warfarin Treatment Booklet "Red Book" – available free from Medidata, phone (09) 488-4272.

3. Has the patient been informed about potential side effects and what to report?

Yes □ No □

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.

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7 This document has been developed based on the Scottish Patient Safety Programme

4. Has the patient been informed about interactions with medicines (prescription, OTC and complementary), supplements, and the effects of food and alcohol?

Yes □ No □

https://aucklandregion.healthpathways.org.nz/index.htm?18972.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)?

Yes □ No □

“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) 488-4272

• SafeRx® Warfarin guides available in English, Chinese, Tongan, Samoan, Niuean, Korean www.saferx.co.nz/patient-guides

6. Have all the measures been met?

Yes □ No □

Data collection question

For all measures to be met, ‘Yes’ must be ticked for all questions 1 – 5

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8 This document has been developed based on the Scottish Patient Safety Programme

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 □

Yes, to some extent □

No □

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.

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

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9 This document has been developed based on the Scottish Patient Safety Programme

9. Could the patient identify at least one appropriate person to ask for help regarding their medicines or side effects?

Yes □ No □

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

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10 This document has been developed based on the Scottish Patient Safety Programme

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, [email protected], mobile 021 537 346, phone 09 486 8920 x 3742.

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11 This document has been developed based on the Scottish Patient Safety Programme

Resources

o Health Pathways information regarding Warfarin https://aucklandregion.healthpathways.org.nz/index.htm?18972.htm

o Waitemata DHB – Warfarin Counselling Checklist and List of Interactions (included in pack) https://aucklandregion.healthpathways.org.nz/Resources/PWarfarin-CounsellingChecklistListofInteractionsMay13.pdf

o BPAC Guidelines: INR for Monitoring Warfarin Treatment www.bpac.org.nz/BT/2010/November/inr.aspx

o New Zealand Formulary: Warfarin www.nzf.org.nz/nzf_1493

o Health Pathways information about Atrial Fibrillation (includes patient information) https://aucklandregion.healthpathways.org.nz/index.htm?18972.htm

o SafeRx® leaflets for warfarin are available in English, Chinese, Korean, Niuean, Samoan and Tongan www.saferx.co.nz

o BPAC article: An update on antithrombotic medicines www.bpac.org.nz/BPJ/2015/April/antithrombotic.aspx

Additional Information

Usual Indications and Duration of Warfarin Therapy Reference: GP Safety in Practice Warfarin Care Bundle 2017

INDICATION TARGET

INR DURATION

DVT or PE due to reversible risk factors

2-3 3 months

DVT or PE due to two unprovoked causes or cancer

2-3 Lifetime

Chronic AF 2-3 Lifetime Mechanical aortic valve 2-3 Lifetime Antiphospholipid syndrome without recurrent VTE

2-3 Lifetime

Mechanical mitral valve 2.5-3.5 Lifetime Mechanical aortic or mitral valve with additional risk factors for VTE

2.5-3.5 Lifetime

Antiphospholipid syndrome with recurrent VTE

3.0-4.0 Lifetime

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12 This document has been developed based on the Scottish Patient Safety Programme

Medicines that can increase the risk of bleeding include6:

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):21-32 www.nzma.org.nz/journal/read-the-journal/all-issues/2010-2019/2017/vol-130-no-1460-11-august-2017/7328 (Accessed 08-09-17)

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. 2003 Jan; 37(1):34-9.

4. 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. 2009 Jul; 43(7):1165-72. Epub 2009 Jun 23.

5. Sawicki PT. Effect of a warfarin adherence aid on anticoagulation control in an inner-city anticoagulation clinic population. JAMA. 1999 Jan 13;281(2):145-50.

6. Waitemata DHB – Warfarin Counselling Checklist and List of Interactions (included in pack) https://aucklandregion.healthpathways.org.nz/Resources/PWarfarin-CounsellingChecklistListofInteractionsMay13.pdf

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13 This document has been developed based on the Scottish Patient Safety Programme

EXAMPLE WARFARIN CHANGE PACKAGE DATA COLLECTION TABLE Pharmacy Name

Date

Review Month

1 2 3 4 5 8

Patie

nt

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:

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14 This document has been developed based on the Scottish Patient Safety Programme

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?

Yes □ No □

2. Has the patient been informed about what to do if they miss a warfarin dose?

Yes □ No □

3. Has the patient been informed about potential side effects and what to report?

Yes □ No □

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? Yes □ No □

5. Has the patient been offered written warfarin information (warfarin red book or

warfarin patient information)?

Yes □ No □

6. Have all the measures been met?

Yes □ No □

Q 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?

Yes □ No □

Patie

nt E

duca

tion

Out

com

e m

easu

res