Setting up the NOAC Service & Taking it to Primary Care Satinder Bhandal Consultant Anticoagulation Pharmacist November 2015 Buckinghamshire Health Care NHS Trust
Quiz 1. What is the most serious side effect of NOACs? a) GI b) rashes c)bleeding d) renal failure 2. What is the half life of the NOACs in normal renal function? a) 12h b) 24h c) 36h d) 48h 3. What percentage of patients stop NOACs at 2years due to side effects? a) 5% b) 10% c) 20% d) 50% 4. The dose of rivaroxaban must be appropriate for which of the following: a) RF b) Weight c) Gender d) Age
Annual data The Statistics Estimate 16,100 strokes are averted including 4,400 fatal strokes by current warfarin treatment 54% of people requiring anticoagulation receive it 8.74% of people requiring anticoagulation have declined it or it is recorded it is contra-indicated Another 46% need anticoagulation Cost & Benefits of Antithrombotic Therapy in England: An Economic Analysis based on GRASF-AF (NHS Improving Quality Report November 2014)
AF and NICE Dabigatran and rivaroxaban approved 2012 Apixaban approved 2013 Need to implement NICE guidance Need to ensure patients benefit from these new drugs Ensure safe prescribing Need to reduce avoidable strokes Manage the entry of these new drugs
Challenges Politics Lack of experience with NOACs On job learning Lack of clarity on place of NOACs Demanding / mis-informed patients Securing funding
Commissioning a Specialist Anticoagulant Decision Unit Convened a meeting of all the key stakeholders Agreed criteria for NOAC use Agreed who could initiate NOACs Agreed to commission a specialist NOAC service Agreed referral pathways Agreed responsibilities of GPs and specialist clinic
GP diagnoses patient with AF and refers to NOAC service New AF patient from primary care NOAC clinic decides on anticoagulation option with patient in line with Bucks criteria Start warfarin Prescribe Counsel patient Alert Card Information Pack Start NOAC, Prescribe Counsel patient, Anticoagulant Alert Card Information pack If warfarin and NOAC unsuitable, consider referral to cardiologist Refer into usual A/C clinic Second contact by phone at 2 weeks: Address issues/concerns/compliance Discharge to GP for continuation If switching NOAC, repeat above stages If switched to warfarin, refer to A/C clinic
Patient with AF identified requiring A/C Hospital Referral Pathway Non- urgent - refer to NOAC clinic Recent TIA or stroke Stroke Team starts A/C Refers to NOAC Clinic clinic CHA2DS2VASC>/= 6 but no TIA or stroke: refer to NOAC clinic for urgent initiation 72hours NOAC clinic agrees anticoagulation with patient in line with Bucks criteria Start warfarin Prescribe Counsel patient Anticoagulation Alert Card Information pack Start/continue NOAC Prescribe Counsel patient Anticoagulant Alert Card Information Pack If warfarin and NOAC unsuitable, consider referral to Cardiologist
Patient referred by GP or BHT clinicians as poor control on warfarin Patient on Warfarin but needs review as may require NOAC NOAC Clinic reviews patient Continues warfarin with further counselling and discharges to usual warfarin monitoring clinic Stops warfarin & considers referral to cardiologist Start NOAC, Prescribe Counsel patient, Anticoagulant Alert Card Information pack Second contact by phone at 2 weeks: Address issues/concerns/complian ce Discharge to GP for continuation If switching NOAC, repeat above stages If switched to warfarin, refer to A/C clinic
The Consultation 30 minute structured consultation Involve patient / relative / carer Carry out risk/benefit assessment Educate on stroke risks & need for anticoag Shared decision making a)start anticoag b) Choice of anticoagulant Prescribe and counsel Follow up arrangements Helpline
Agree the right drug for the patient Stroke risk Bleeding risk Extreme age Extreme weight Co-morbidities Renal function Liver function Risk of ICH TTR Risk of side effects Need for MDS Lack of licensed antidotes for NOACs Mitral stenosis or mechanical heart valve Adherence with complex regimens Compliance issues
NEW PATIENTS Locally Agreed Criteria for NOAC Use High risk of interactions with warfarin leading to unacceptable INR fluctuations which cannot be addressed. Co-morbidities which make INR control challenging e.g. unstable severe COPD or recurrent cellulitis Regular INR monitoring is difficult or impractical after exploring all possible alternatives eg. immobile patients requiring home visits from phlebotomy Adherence to variable and complex warfarin dosage regimens is likely to be poor Secondary prevention of Af patients with recent stroke or TIA. To be referred by secondary care stroke service
Locally Agreed Criteria for NOAC Use (2) EXISTING WARFARIN PATIENTS Poor INR control (TTR < 65%) despite evidence of compliance Allergy to or intolerable side effects from warfarin which would require warfarin withdrawal
Counselling Patient explanation Condition / Purpose of medicine /Duration If NOAC, lack of antidote How to take in relation to food & regimen Monitored dosage aids warfarin and dabigatran not in dosette Compliance Action if missed dose Alert Card Informing healthcare professionals (surgery /dental/injections/pregnancy/meds) Interactions pain relief /OTC medicines Side-effects/ Warning signs/ Emergency Alcohol /Diet Follow up arrangements
Telephone Follow up Questions for Patient or Carer Have you had a chance to start taking your medicine yet? How are you getting on with it? Are you having any problems with you new medicine or concerns? Do you understand why you need anticoagulation? Do you think you are getting any side-effects or unexpected effects? Have you missed any doses or changed when you take it? Do you have anything else you would like to know or anything you would like me to go over again?
Identifying the Opportunities High cost medicines Medicines with complex prescribing regimens Narrow therapeutic medicines Medicines requiring shared decision making and intensive adherence support Combination prescribing for new patients, naïve to medicines
Develop new skills Independent prescribing Have expertise in area in which you wish to set up new service Network with local leaders in the specialism
Find a Champion Engage Chief Pharmacist and CCGs Pharmacists Meet informally with key stakeholders Get buy in from them Get them to advocate for you You should have agreement with them for what you want to achieve before the formal decision making meeting
Business Case Find out locally accepted format Use the same headings Account for administration time Ask finance to help Be realistic about timescales for implementation including writing and approval of shared care guidelines, care pathways, referral forms, service specification
Audit Agree what data your commissioners will require Agree timing and frequency Decide other audits you need to conduct for the development of your service Research?
Celebrate Your Success Talk about your work Write up audit results Publish Acknowledge others input Maintain relationships with stakeholders Continue to deliver a good service
NOAC Service Audit If a friend or relative needed similar treatment, would you be happy to recommend the standard of care in the clinic? 70 60 50 40 30 20 10 0 Extremely likely Likely Neither likely or unlikely Unlikely Extremely unlikely Don't know If a friend or relative needed similar treatment, would you be happy to recommend the standard of care in the clinic?
Did you have confidence and trust in the pharmacist? 90 80 70 60 50 40 30 20 10 0 Yes definitely Yes, to some extent No, not really Did you have confidence and trust in the pharmacist?
Were you involved as much as you wanted to be in decisions about your treatment? 90 80 70 60 50 40 30 20 10 0 Yes definitely Yes, to some extent No, not really Were you involved as much as you wanted to be in decisions about your treatment?
Did a member of staff explain the purpose of the medicines you were to take at home in a way you could understand? 90 80 70 60 50 40 30 20 10 0 Yes, completely Yes to some extent No I did not need an explanation I had no medicines Did a member of staff explain the purpose of the medicines you were to take at home in a way you could understand?
Did a member of staff tell you about medication side effects to watch for when you went home? 80 70 60 50 40 30 20 10 0 Yes, completely Yes to some extent No I did not need an explanation Did a member of staff tell you about medication side effects to watch for when you went home?
Moving the Services to Primary Care Making the most opportunities Having the right skills, knowledge and expertise Having capacity to expand Act quickly Make full use of your team, stakeholders & Chief Pharmacist
Moving the NOAC Service into GP Practices (1) HCA practice based anticoag clinic pulled Very elderly patients anticoagulated at the practice Difficult for them to access acute provider clinics Urgent replacement service required and CCG approached NOAC service NOAC service stepped in with a GP practice based weekly clinic
Moving the NOAC Service to GP Practices (2) Any Qualified Provider for anticoagulation clinics Competition from other providers Boots, GP practices, other acute trusts BHT has taken on some GP practices Out reach clinics set up in GP practices for warfarin dosing and local NOAC service for patients
Moving the NOAC Service to GP Practices (3) Poorly controlled patients on warfarin GPs auditing there own anticoagulant clinic patients to ensure they are well controlled and referring patients to be considered for a NOAC are an opportunity Large batch of referrals from a practice presents an opportunity Running a clinic in first such practice to review patients for a NOAC within the practice
Summary How the NOAC service was established Care pathways in Bucks Consultation Identifying & being ready to benefit from opportunities Business Cases Developing your service into primary care