1 This document has been developed based on the Scottish Patient Safety Programme
Community Pharmacy Safety in Practice
Warfarin Change Package 2017
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
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 education on collection of their warfarin.
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.”
4 This document has been developed based on the Scottish Patient Safety Programme
Process and Patient Outcome Measures The process measure questions assess whether there is documented evidence of the measures. The patient outcome measure questions assess whether the patient has understood and can recall the information provided. These questions relate to the patient or carer as applicable. Please see Table 1: Measures and Rationale below for further guidance regarding these measures.
Part 1: Warfarin Process Measures Questions 1 – 5 relate to whether there is documented evidence of the following activities. Question 6 is a review of questions 1 – 5.
1. Does the patient know their target INR and current warfarin dose?
2. Has the patient been informed how to take their warfarin and 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 warfarin 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 – 10 are patient questions to assess patient outcomes via follow up eg phone call.
7. Could the patient appropriately tell you when to take warfarin?
8. Could the patient appropriately tell you what they would do if they miss a dose of warfarin? 9. Could the patient identify at least one of the common side effects of warfarin? 10. Could the patient identify at least one appropriate person to ask for help about their
medicines or side effects?
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.
Note: We DO NOT require NHI or patient identifiable data, so please ensure it is anonymous.
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 low scores for the baseline September 2017 data, where interventions occurred prior to the Safety in Practice programme beginning, so do not worry.
6 This document has been developed based on the Scottish Patient Safety Programme
Table 1: Measures and Rationale Please note: these questions relate to the patient or carer as applicable.
# Measure Rationale
1. Does the patient know 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
If the patient does not know their target INR, and this information is not documented on testsafe or a recent clinical letter or EDS, you could recommend that your patient discusses with their GP Nurse.
2. Has the patient been informed when and how to take their warfarin and 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. Some medicines and supplements can increase bleeding risk without increasing INR.
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.
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 □
Advise patient about the various products that can interact with warfarin. You can refer to the Health Pathways information, the warfarin red book, or the Waitemata DHB warfarin counselling checklist and interactions list.
https://aucklandregion.healthpathways.org.nz/index.htm?18972.htm
Advise the patient to check with their doctor or pharmacist before making any lifestyle changes. Eg before starting or stopping any other medicines especially antibiotics, and 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
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. Remember to use open questions to hear the answers from the patient.
Note: 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 appropriately tell you when to take warfarin?
Yes □ No □
Ask the patient: Tell me, when do you take your warfarin? You may need to prompt them for more information.
Answer guidance:
Yes – if the patient knows to take it once daily, ideally at the same time each day.
No – if the patient couldn’t explain when to take the warfarin
8. Could the patient appropriately tell you what they would do if they miss a dose of warfarin?
Yes □ No □
Ask the patient: Tell me, what would you do if you forgot to take your warfarin?
Answer guidance (refer to Warfarin Red book or other resource):
Yes – if the patient knows to take it if they remember the same day, but to skip it if they’ve missed the dose that day. Carry on from there.
No – if the patient couldn’t appropriately explain what they should do if they missed a warfarin dose.
9. Could the patient identify at least one of the common side effects of warfarin?
Yes □ 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. Refer to Question 3 above.
Answer guidance:
Yes - if the patient could identify one or more common side effect
No - if the patient couldn’t name any side effects
10. 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? Appropriate answers may include examples such as Pharmacist, Pharmacy staff, Doctor, Nurse, hospital staff.
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
9 This document has been developed based on the Scottish Patient Safety Programme
Initial Things to Consider
- What is the current process for patient education?
- What warfarin resources do you want to provide to patients?
- 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.
10 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. “Warfarin: What you need to know” leaflets are available at www.saferx.co.nz in English, Chinese, Korean, Niuean, Samoan, and Tongan
o BPAC article: An update on antithrombotic medicines www.bpac.org.nz/BPJ/2015/April/antithrombotic.aspx
o Anticoagulant Treatment Booklet "Red Book" – available free from Medidata, phone (09) 488-4272
o Pharmac Online Resources – http://www.pharmaconline.co.nz. Pharmacists in Auckland, Counties-Manukau and Waitemata can use the "Starting on Warfarin" leaflet and DVD for education. Hard copies can be ordered from the above website.
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
11 This document has been developed based on the Scottish Patient Safety Programme
EXAMPLE WARFARIN CHANGE PACKAGE DATA COLLECTION TABLE *Refer to Excel Spreadsheet for official data collection spreadsheet*
Pharmacy Name
Date
Review Month
1 2 3 4 5 6
Pat
ien
t Does the patient know their target INR and current warfarin dose?
Has the patient been informed when and how to take their warfarin, and 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:
12 This document has been developed based on the Scottish Patient Safety Programme
EXAMPLE CHECKLIST – Feel free to adapt for use in your pharmacy Community Pharmacy Safety in Practice – Warfarin Checklist Patient NHI/Name
Date
1. Does the patient know their target INR and current warfarin dose?
Yes □ No □
2. Has the patient been informed when and how to take their warfarin, and 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 warfarin 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 (eg warfarin red book, SafeRx®
warfarin leaflet or other warfarin patient information)?
Yes □ No □ 6. Have all the measures been met?
Yes □ No □
Questions 7 – 10 are patient questions to assess patient outcomes. Ask patient via follow-up phone call. 7. Could the patient appropriately tell you when to take warfarin?
Yes □ No □
8. Could the patient appropriately tell you what they would do if they miss a dose of warfarin?
Yes □ No □
9. Could the patient identify at least one of the common side effects of warfarin?
Yes □ No □
10. Could the patient identify at least one appropriate person to ask for help regarding their medicines or side effects?
Yes □ No □
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ien
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