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SAFE AND EFFECTIVE PRESCRIBING - 2 Safe prescribing a case study and Anticoagulation key messages Dr Ian Coombes, Senior Clinical Lecturer University of Queensland Schools of Medicine and Pharmacy Safe Medication Practice Unit, Queensland Health The University of Queensland Session Objectives (week 2) At the end of these tutorials students should have: An increased awareness of common prescribing error traps Enable students to apply key principles of safe prescribing Facilitate students writing regular in hospital prescription Understand key points for safe prescribing of anticoagulants Latent factors Organisational/ Management– work load, hand written prescriptions, staffing Culture of lack of support for interns Lack of safety training and awareness of risks as undergraduate To recap – why interns make mistakes Error-producing factors Environmental – busy ward, interruptions Team – lack of supervision, hierachy Individual – limited knowledge, information Task - repetitious, poor medication chart design Patient – complex, communication difficulties Active failures Error – slip, lapse or Violation Defenses Inadequate – Guideline confusing No pharmacist Harm How a patient with documented ADR to cephalosporin received two more doses {From Reason’s Swiss Cheese Model} Verbal order by Surgeon for antibiotic in OT Transcribed by Registrar to medical notes/record Phone call – Nurse to ward call dr (outlier) Prescribed by Dr (1st term junior) Severe anaphylaxis, dialysis, steroids, antihistamines Prepared by Nurse 1 (busy) Check Nurse 2 (agency) Patient (asleep) Given by RN Re-exposure to Cephalosporin Patient Factors Sedated, post op Task Factors Writing a prescription some one else ordered Practitioner Factors Hungry, tired, late, inexperienced, ill-informed Team Factors What team? – Outlied patient, ward call doctor Workplace Factors Medicine charts – ADRs/Allergies on front of chart – order on inside Organisation Factors Did not invest in safety systems or training for safe prescribing Patient Factors ADR/ alert bracelets Task Factors Reduce delegation of tasks Practitioner Factors Drs hours + training + support Team Factors Safe prescribing – lead by consultants Workplace Factors Medicine charts – ADR on chart where prescribing + administration Organisation Factors Acknowledge and Invested in safety + system change + education So What is a Prescribing? The Prescribing process Information Retrieval – Presenting complaint, History, Lab Monitoring and review Patient Decision re, Drug, route, dose vs Patient, disease, drugs Mainly Snr doctors Instruction to: prescribers, pharmacists, nurses 7 Mainly Jnr Doctors And or nursing staff Coombes I, PhD Key stage of prescribing for junior doctors is… COMMUNICATING information about: drug form route dose frequency administration time/s administration of IV meds duration of therapy in a CLEAR, UNDERSTANDABLE form to: other doctors nurses pharmacy staff Case Study – Mr AD 68 y.o. 60 kg ♂ presents to ED PC: SOB pyrexial and sputum HoPC: 2/52 increased, cough, sputum, fever 7 days of amoxycillin from local (private Dr) no response Exam: BP 110/70; HR 90; RR 19, bi-basal chest crackles Creatinine, urea other E, LFTs Normal PMH: RA (10 yrs); HT (20 yrs), Dx: URTI Social Hx: lives alone ADR: Erythromycin – severe Hives, rash – 2005 68 y.o. 60 kg ♂ presents to ED PC: SOB pyrexial and sputum HoPC: 2/52 increased, cough, sputum, fever 7 days of amoxycillin from local (private Dr) no response Exam: BP 110/70; HR 90; RR 19, bi-basal chest crackles Creatinine, urea other E, LFTs Normal PMH: RA (10 yrs); HT (20 yrs), Dx: URTI Social Hx: lives alone ADR: Erythromycin – severe Hives, rash – 2005 Your Registrar asks you to write up Mr AD’s drug chart (DOB: 01/4/40; UR:155566; date: today; ward: medical) Captopril oral 25mg BD Diltiazem SR oral 240mg mane Methotrexate oral 10 mg weekly on Sunday morning Co-amoxiclav oral1 TDS Clarithromycin oral 500mg BD Write up the medicines the person should have Pass to the Person Next to You Is Everything OK? Imagine you are a junior nurse at 8 a.m. on Friday Name - care with “sound alikes” - Piroxicam + Proscar (trade) Drug Form – immediate vs sustained release - e.g. Diltiazem sustained release vs standard Combinations – Co-amoxiclav – contains penicillin Strengths - if unsure,(1 tablet) make a clinical decision Route - oral, IV, IM, SC, IT – can they take it? Dose - multiple/partial tablets & decimal points - e.g. digoxin 62.5 micrograms, 5.0 units insulin Frequency - explicit standard terms – NB: weekly medication (cross out unnecessary days) Times to be entered by doctor when prescribing? ADR – Erythromycin = Hives Marks: Patient name = 5 marks All drug names – clear = 4 marks All routes – clear = 4 marks All doses + frequencies = 4 marks SR form of Diltiazem = 4 marks (no SR = -4!) Weekly methotrexate – block out = 10 marks (Did not block out -10 mark Did not prescribe Clarithromycin = 10 marks, (DID prescribe = -20 mark ADRs Class effects (macrolide antibiotics) :common trap BEWARE trade names and combination drugs Document all relevant ADR details on chart BEFORE prescribing! ADR details in medical chart/notes as well Ask patient , carer, previous notes Check with patient and chart and front of medical record file BEFORE prescribing Sustained release drugs What if the patient gets 4 x 60 mg tablets ? Hypotensive = bradycardic Weekly medicines Medicines to be taken once a week: Ie Methotrexate for arthiritis Alendronate for osteoporosis Significant risk that your order may be misinterpreted by nursing staff and patient may receive daily = pancytopenia Ceasing Medications Physically block further administration Prevent transcription errors but still legible for records Sign and Date, reason for ceasing State Reducing the risk of adverse events Always include a detailed drug history in the consultation Only use drug treatment when there is a clear indication Stop drugs that are no longer necessary Check dose and response, especially in the young, elderly and those with renal, hepatic or cardiac disease Medication Assessment/ Review • • • • Does the patient need this drug ? Is this drug the most effective and safe ? Is this dosage the most effective and safe ? If side effects are unavoidable does the patient need additional drug therapy for these side effects? • Will drug administration impair safety or efficacy ? • Are there any drug interactions ? • Will the patient comply with prescribed regimen ? Summary Accidents happen everywhere The best people make mistakes Same “simple” mistake - different consequences Everyone is responsible for patient safety Writing an order is as important as making the decision what to prescribe If in doubt check! Anticoagulants - Objectives Anticoagulation Why, where, when and when NOT to! Heparins Low Molecular Weight Heparin (LMWH) Standard Unfractionated Heparin Heparinoids (eg danaparoid) Warfarin Anticoagulation and Surgery Reversal Anticoagulation: The classic balance between risk and benefit of medication The margin for error is relatively small Past Incidents “Most frequent cause of preventable drug related harm” (Quality in Australian Health Care Study) Inadequate anticoagulation and emboli Warfarin omission on discharge – embolic events Out-of-hours dosing - bleeds Drug interactions resulting in enhanced (eg bleeds) or inadequate effects LMWH dosing and bleeds Anticoagulation Indications? Indications for anticoagulation? Primary prevention: Atrial Fibrillation (AF), left ventricular dilatation, mural thrombus DVT/PE in hospitalised patients (medical and surgical) Secondary prevention: Thromboembolic events (DVT, PE) Acute coronary syndrome (ACS) Peripheral vascular disease (PVD) Post CVA; AF Adjunctive treatment: Myocardial infarction (MI) Anticoagulation Contraindications? Contraindications to Anticoagulation? Bleeding disorders, including haemophilia Uncontrolled active bleeding Major trauma or recent surgery Thrombocytopenia (including HITTS)* Cerebral haemorrhage Peptic ulcer Severe uncontrolled hypertension Severe hepatic disease Bacterial endocarditis *heparin/LMWH contraindicated Anticoagulation Prophylaxis Initial Treatment Mostly fractionated heparin Occasionally unfractionated heparin Very occasionally warfarin (eg AF) Subsequent Mostly warfarin Occasionally heparin if warfarin contraindicated (eg pregnancy) Prophylaxis: LMWH HIGH RISK: - 40 mg sub-cut 12 hrs pre-op, then once/day for 7-10 days or until mobilised (NB: continue up to 30/7 for total hip replacement surgery) MODERATE RISK: - 20 mg sub-cut 2 hrs pre-op, then once/day for 7-10 days or until mobilised MEDICAL PATIENTS: - 40 mg/day sub-cut for 6-14 days or until mobilised PROLONGED PROPHYLAXIS (eg hip replacement): - 40 mg/day sub-cut for up to 30 days HAEMODIALYSIS: - 0.5-1 mg/kg (via arterial line) at start of session Treatment: LMWH (enoxaparin) ESTABLISHED DVT: - 1 mg/kg BD (inpatients) - 1.5 mg/kg/day (outpatients) High risk patients 1 mg/kg BD more beneficial - Start warfarin on the same day as heparin Overlap with LMWH for a minimum of 5 days and until INR has been therapeutic for at least 2 consecutive days Unstable angina & non-Q-wave MI: - 1 mg/kg BD for 2-8 days - + aspirin 100–325 mg/day Low Molecular Weight Heparin Any benefits compared with conventional intravenous (IV) unfractionated heparin? Benefits of LMWH Predictable dosing Must weigh the patient or calculate LBW No monitoring of APTT required Can treat in the community as outpatient No pump required Low Molecular Weight Heparin Risks? LMWH – No Panacea! 7% of QH high risk incidents related to enoxaparin! Sub-cut vs IV not seen as “special” drug Inaccurately promoted as “safe” alternative to heparin because it “doesn’t need monitoring” Risks of LMWH Risks Action Risks of LMWH Risks Must know weight Must know baseline renal function (CrCl) Care with dose timing eg peri-procedural Reversal can be difficult Action LMWH and Renal Impairment AVOID if possible! Dose adjustment if CrCl < 30 mL/min - Prophylaxis: 20mg once daily - Treatment: 1mg/kg once daily Low Molecular Weight Heparin Risks Must know weight Action lean body weight (max 100kg and min 40kg) Must know baseline renal < 30mL/min = use IV heparin and function (CrCl) monitor APTT Care with dose timing eg peri-procedural t ½ = 12 hrs (care with upcoming surgery or starting post-op) Reversal can be difficult partially reversed with protamine Case Study I 67 y.o. ♂ Mr AD - UR: 123 456 - DOB: 25/02/41 - 32 Pharmy Lane, Drugsville Admitted 5 days ago - SOB, PND PMHx: Dx - Worsening heart failure, 2o to NSAID and sub-optimal therapy Weight: 70 kg Creatinine: 180 micromol/L (normally 120) Observations - HR 75 - BP 145/90 - IHD; AMI ’98; HF; T2DM; ADR HT; RA - penicillin (angioedema? 1999) Prescribing Anticoagulation Patient develops DVT No thrombophilia found Ward round decision: – Start heparin – how and what? – has renal impairment – CrCL = 30mL/min – Iv heparin with aptt monitoring Heparin Reversal Protamine combines with heparin to form a stable, inactive complex 1mg protamine neutralises 100 units heparin if given within 15 min of heparin At risk of allergic reaction to protamine: - Patients having undergone procedures where protamine used, e.g. coronary angioplasty, cardiopulmonary bypass - Diabetics treated with protamine insulin - Patients allergic to fish - Vasectomised or infertile men (may have antibodies to protamine) IV unfractionated heparin Key Messages IV indications: - ACS or in place of warfarin maintenance e.g. if patient having surgery and warfarin stopped - Surgery e.g. Neuro/vascular surgery - PE/ DVT (as an alternative to LMWH) Organise baseline APTT and full blood count Check if patient recently prescribed/administered - enoxaparin / LMWH fibrinolytic agent (thrombolysis) warfarin and antithrombotics Weight adjusted bolus and initial rate of infusion based on indication For monitoring, use nomogram (based on indications) Significant inter-patient variability Task: Initiating Warfarin Assess individual benefit vs risk - Consider age, weight, other Rx, indication, duration, co-morbidities…. Baseline INR to exclude coagulopathy Start on first day of heparin therapy Overlap warfarin with full heparin dose - For a minimum of five (5) days and - INR therapeutic for at least two (2) consecutive days Warfarin - Key Messages Target INR – documented? Indication specified Duration of treatment Daily INRs initially – subsequent monitoring Consider drug interactions Patient education imperative Warfarin guidelines available for PDA http://qheps.health.qld.gov.au/qhmms/docs/wafarin_guidelines_pda.pdf Risks of Warfarin INR > 4 ≈ 10 x bleeding risk vs INR 2–3 Bleeds associated with time INR > target Some patients will bleed INR < 2 Associated risks: - Anti-platelet therapy - Change in any medication - Falls - Surgery - Lack of monitoring - Any illness Guidelines Risk factors for increased sensitivity to warfarin - Interacting rx - Hx bleeding - Baseline INR > 1.4 Starting nomogram Target INR ranges Minimum durations Warfarin management peri-operatively Warfarin reversal Warfarin drug interactions Case Study II 69 y.o. ♂ patient with Ca. prostate + Hx COPD Admitted with bleeding peptic ulcer Recent chest infection managed by GP U&E / LFTs – NAD Regular Rx (as per discharge 4/12 ago): - Marevan® (warfarin) 2 x 1mg daily (long term for recurrent DVTs) INR 5.8 (usually stable at 2-2.5, checked monthly) - MS Contin® (morphine controlled release) 30mg BD - Flixotide® (fluticasone) MDI, 1 puff BD - Ventolin® (salbutamol) MDI 1-2 Q4-6hrs PRN What is going on? Key Messages INR may increase or decrease for many reasons, for example: - Poor concordance/compliance - Changes to medications Drug interactions Addition/removal of medicine Change in dose Case Study II Cont… GP had started roxithromycin (Rulide®) 300mg/day for 10 days GP concerned with the potential interaction, i.e. inhibition of warfarin metabolism, so he checked INR day 2 post roxithromycin initiation: - INR 2.5 Effect delayed by ≈ 72 hours NOT detected by day 2 INR! NB Augmentin® (amoxycillin + clavulanate) will also potentially raise INR Warfarin and Surgery Depends on patient and risk: Low risk (uncomplicated AF) - Stop 4-5 days prior Check INR day of procedure Re-start USUAL dose ASAP Employ thrombo-prophylaxis as per hospital policy High risk – SEEK ADVICE - Cease warfarin 4-5 days prior - 2-3 days before surgery, commence treatment dose of IV heparin or LMWH subcutaneously - Re-start USUAL dose ASAP (cover with a heparin) - Cease heparin (IV heparin or LMWH) 48 hours after the target INR is reached WARFARIN REVERSAL (end of bed chart) INR > therapeutic range but withhold < 5 and NO bleeding review INR and dose INR 5 – 9 and NO bleeding withhold give vitamin K, 1-2mg orally (0.5-1mg IV) review INR and dose INR > 9 and NO bleeding Low risk of bleed withhold give vitamin K up to 5mg orally (0.5-1mg IV) review INR and dose High risk of bleed withhold give vitamin K 1mg IV consider Prothrombinex™-HT, FFP review INR and dose Any clinically significant bleeding where warfarininduced coagulopathy considered a contributing factor SEEK SENIOR ADVICE cease warfarin give vitamin K 5-10mg IV Prothrombinex™-HT, FFP review INR frequently < 5 and bleeding stops Key Messages Anticoagulation - Most frequent high risk drugs you will prescribe Assess risks and benefits enoxaparin - no panacea - Need to know renal function, weight, timing Prescribing can not be too explicit If in doubt, ASK! Information available includes - Guidelines for anticoagulation using warfarin (end of bed) - Heparin Intravenous Infusion Order & Administration Form - Your friendly pharmacist!