Quality Use of Medicines. Linda Graudins Senior Pharmacist, Medication Safety Alfred Health

Transcription

1 Quality Use of Medicines Linda Graudins Senior Pharmacist, Medication Safety Alfred Health Palliative Care Consortium July 2013

2 Quality Use of Medicines Introduction Avoiding harm The meaning of QUM Extent of medicines use What happens after the prescription Adverse Drug Events (ADEs) Example of HYDROcodone ADRs and Drug Interactions Prescribing, dispensing safely Problems in transition; Med Reconciliation Getting the 6 rights Medication safety tips Resources & questions Useful resources here and overseas

3 Introduction National Medicines Policy Timely access to affordable medicines PBS Value for money Distribution and supply networks 2. Medicines meeting standards of quality, safety, efficacy TGA Regulation of development, production and supply Pre-marketing assessment and post-marketing monitoring 3. Maintaining a viable medicines industry

4 National Medicines Policy & QUM 4. National Strategy for Quality Use of Medicines (QUM) i. Judicious only when needed ii. Appropriate to clinical condition, dose, risks and benefits, costs iii. Safe use iv. Efficacious minimise overuse and misuse achieve goals of therapy to achieve health outcomes Benefit Risk

5 Patient centred QUM approach Alma is 80 years old presents with chronic pain. She has a temp of 38C i. Judicious use of medicines Do you need to treat pain + fever with medications +/- other measures? Review current analgesia Viral infection? ii. Appropriate Which infection is the most likely? What medications is she taking already? Bacterial infection- which antibiotic? What are the relevant treatment protocols for pain relief? iii. Safe use Rehydration needed? How does she take her medications- liquid, slow release? Do the carers know how to give the medications? Have they got a measuring device? What is the dose for age? What about drug interactions? Does she have any allergies or history of adverse reactions e.g. opioid sensitivity? iv. Efficacious Monitor pain scores. Does she need any medicines-specific information? After treatment, did the fever decrease? How is her renal function ( e.g. NSAIDs)? Arrange follow-up.

6 QUM in the medication management cycle i. Judicious use of medicines iv. Efficacious ii. Appropriate iii. Safe use

7 Extent of medication use Community 200 million prescriptions dispensed in community pharmacies 10 prescriptions per person per year 69% of the population in any 2 week period have taken a medicine > 91% for those over 65 year years Residential care facilities Average 7 medications Hospitals Average 8 medications 5 to 7 changes during hospitalisation Be friends with your pharmacist! Roberts MS et al. Medication prescribing and administration in nursing homes. Age Aging 1998; 27; Harris J, Finuncane P, Healy D, Bakarich A. Medication usage in hospital nonagenarians. Intern Med J 2002; 32: 104-7

8 Appropriate use what happens after dispensing the prescription? One in six elderly patients re-pack prescription medicines One in ten mix their medicines in the same container 40% still keep medicines they no longer use One in five patients share medicines 2% had used someone else s prescription medicines 20% patients admitted altering doses to reduce costs One in ten patients using multiple brands of the same medicine Thompson S, Stewart K. Prescription medication use practices among non-institutionalised older persons. Int J Pharm Pract 2001; 9: Vik SA, Maxwell CJ, Hogan DB. Measurement, correlates and health outcomes of medication adherence among seniors. Ann Pharmacother 2004; 38: Stewart S, Pearson S. Uncovering a multitude of sins: medication management in the home post acute hospitalisation among the chronically ill. Aust N Z J Med 1999;29: Sorensen L, Stokes JA, Puride DW, Woodward M, Roberts MS. Medication management at home: medication-related risk factors associated with poor health outcomes. Age Aging 2005; 34:

9 This medication belonged to a single patient and was collected by a nurse and caseworker during a home visit. Pictured are expired medicines; refilled prescriptions, partially or totally unused, some with increased dosage amounts; prescriptions written for someone other than the patient; and prescriptions from several different providers.

10 Adherence issues: Medicines prescribed are not always taken Patient wants to follow treatment BUT Patient factors Poor recall, Hearing or visual impairment Non English speaking Poor comprehension of instructions Forgetfulness or dementia Living alone/no carer Lack of information/discussion Difficulty in administering treatment Medication factors Cost Complicated dosing plan > Dose titration, variable dosing Adverse drug reactions Packaging > Size, formulation or taste > Small print size on labels Patient decides not to follow treatment Does not believe in need for medicine Concerns of side effects Fears of dependence Denial of illness Mistrust of health clinician Cultural taboos and beliefs

11 Safe use Increased number of products, formulations, brands Number of paracetamol-containing products Number of opioid formulations

12 Do you know your opioid formulations? MORPHINE (44 formulations) Tablets Sevredol 10,20 mg Anamorph 30mg Slow release preparations MS Contin, 5,10,15, 30, 60, 100, 200mg Momex tablets 5,10,15, 30, 60, 100, 200mg Morphine MR 10, 30, 60, 100mg Kapanol capsules 10,20,50,100mg MSMono capsules 30,60,90,120mg MSContin suspension sachets 20,30,60,100, 200mg Liquid Ordine 1, 2, 5, 10mg/mL Injection Intrathecal 200, 500 microg/ml Sulphate 5,10,15,30mg / ml Tartrate 120mg/ 1.5mL

13 Do you know your opioid formulations? OXYCODONE Tablets Endone 5mg OxyNORM capsules 5, 10, 20 mg Slow release OxyCONTIN tablets 5,10,15,20, 30,40, 80 mg *Targin (with naloxone) capsules 5, 10,20,40 mg Injection 10, 50mg Liquid OxyNORM 1mg/mL Suppositories Proladone 30mg FENTANYL Actiq lozenge, 200, 400, 600, 800, 1200, 1600 mcg Fentanyl Intranasal 300 mcg/ml Sublimaze inj, 50 mcg/ml, Patches Denpax, Durogesic, Fenpatch 12, 25, 50, 75, 100 mcg/hour BUPRENORPHINE Temgesic tablets 200 mcg (sublingual) Temgesic inj, 300 mcg/ml Norspan patch, 5, 10, 20 mcg/hour METHADONE Physeptone tablets 10mg Injection 10mg/mL Biodone, Methadone mixture 5mg/mL *More information. Oxycodone-with-naloxone controlled-release tablets (Targin) for chronic severe pain NPS RADAR 25 October 2011

14 Codeine: not recommended for chronic pain Tablets codeine 30mg codeine 8 mg, aspirin 300 mg (dispersible)aspalgin codeine 12.8 mg, ibuprofen 200 mg, Nurofen Plus, Panafen Plus, Rafen Plus, ProVen Plus codeine 8 mg, paracetamol 500 mg Codalgin, Panamax Co. Panadeine codeine 15 mg, paracetamol 500 mg Prodeine 15 codeine 30 mg, paracetamol 500 mg Panadeine Forte, Codalgin Forte, Codapane Forte, Comfarol Forte, Prodeine Forte Linctus 5 mg/ml Injection 50mg/mL 1. Variable metabolism- fast and slow metabolisers 2. Tolerance- higher doses required, leading to increasing side effects 3. Multiple interactions 4. Combination products- increase toxicity risk More information.cautions with codeine Aust Prescr 2011;34:133-5

15 Safe use of patches

16 Safe Medication management Risk assess your patient 1. De-prescribe simplify e.g. rationalise opioids/benzodiazepine See updated Beer s criteria in elderly patients 2. Increase patient adherence patient/carer involvement, joint agreement, medication list with indication follow-up: carers and health team (p cist, nurses) know the plan 3. Simplify medicines and formulations For the patient: Memory aides; information; dose administration aids For the prescriber: know the medications used in your practice 4. Safe storage and administration of medicines Pharmacist advice and monitoring Storage and disposal of unwanted medications 5. Consider ehealth registration

17 AGS UPDATED 2012 BEERS CRITERIA Organ System or TC or Drug Rationale Recommend. Quality of Evidence Table 2. Drugs Risk cognitive to Avoid effects (except Avoid for treatment if ) Benzodiazepines Short and long acting and injury fall MVA appropriate withdrawal of insomnia, agitation, or delirium High Strength of Recommend. Strong Megestrol Minimal effect on weight; risk of thrombotic events and death Avoid Moderate Strong Metclopramide EPS and TD Avoid, unless gastroparesis Moderate Strong Non-COX NSAIDs, oral GI bleeding; Protection w/ PPIs or misoprostol Avoid chronic use Moderate Strong

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19 Adverse Drug Events (ADEs) including ADRs, drug interactions Adverse drug event (ADE): any incident in which the use of a medication (drug or biologic) at any dose, a medical device, or a special nutritional product (dietary supplement, infant formula, medical food) may have resulted in an adverse outcome in a patient. Pharmacovigilence: science of collecting, monitoring, researching, assessing and evaluating information on the adverse effects of medications ADEs can be : (1) medication errors, which are preventable (2) adverse drug reactions (ADR), which are generally not preventable

20 Adverse drug events (ADEs) ADEs are medication-related harm 5% of hospital admissions fatal in up to 3 in 1000 medical inpatients Complicate drug therapy decrease adherence delay discharge Increase costs to PBS, taxpayer treatment of reactions caused by inappropriate Rx under-treatment of diseases e.g. IHD, osteoporosis hoarding and wastage of medications not taken due to adverse effects

21 ADEs result from prescribing, dispensing or administration errors 1. Drug not suitable e.g. antibiotics for viral infections 2. Dose, frequency, route, inappropriate e.g. crushing controlled-release opioid 3. Previous known allergy e.g. previous reaction to naproxen- given diclofenac 4. Known interaction not picked up/ documented 5. 6 rights not followed Schumock GT, Thornton JP (1992) Focusing on the preventability of adverse drug reactions. Hosp Pharm 27:538

22 ADE example: HYDROmorphone HYDROmorphone Tablets Dilaudid, 2, 4, 8 mg Controlled release tablets Jurnista 4, 8, 16, 32, 64 mg Oral liquid Dilaudid, 1 mg/ml, 473 ml Injection Dilaudid, 2, 10 mg/ml, 50mg/5mL and 500mg/50mL 1. Pennsylvania Patient Safety Authority 2. Hydromorphone prolonged-release tablets (Jurnista) for chronic severe disabling pain NPS RADAR 01 May 2009

23 ADEs: HYDROmorphone cases An order was written for 1.5 mg/hour of hydromorphone with a 1.5 mg bolus every 10 minutes instead of a bolus of 0.3 mg every 10 minutes. The patient received 16.8 mg over a six-hour period and then was found unresponsive An elderly patient was admitted with left leg edema ulcerations with significant pain. Within eight hours, the patient received morphine 2 mg IV, Dilaudid 2 mg IV two times, and was started on a Duragesic (fentanyl) patch. One hour later, the patient was found unresponsive. Narcan was given, and the patient responded immediately. The patient was on a standard 1 mg/ml infusion of Dilaudid, but a 5 mg/ml concentration was sent instead. The nurse did not reprogram the PCA pump, which led [to respiratory distress].. Pennsylvania Patient Safety Authority

24 Safety strategies to prevent opioid ADEs 1. Use your pharmacokinetics e.g. The estimated relative potency of IV HYDROmorphone compared to IV morphine ranges from 4:1 to as high as 8:1.5 In an opioid-naïve patient, 2.5 mg to 5 mg of IV morphine would be equivalent to 0.3 mg to 0.7 mg of HYDROmorphone 2. Standardise by using protocols, conversion tables 3. Risk management ensure oxygen, naloxone available. give carers a plan for dose titration, a list of signs and symptoms of opiate overdose.

25 Safety strategies to prevent opioid ADEs cont. 4. Double check prescription using computer prescribing and dispensing alerts 5. Storage and dispensing store similar sounding names and strengths separately, differentiate strengths by coloured labels or containers, TALLman lettering, shelf alert stickers Barcode scanners Provide a dose measure for mixtures 6. Education and information patient, carer and staff

26 Patient presents Disease or ADE or ADR or.? Rhabdomyolysis Anaphylaxis Stroke Acute on chronic renal injury Arrhythmia Seizure DVT Meropenem +valproate Statin+ erythromycin Pamidronate Penicillin Lithium toxic Strontium Citalopram

27 ADE or.? Patient presents Rhabdomyolysis Anaphylaxis Stroke Acute on chronic renal injury Arrhythmia Seizure DVT Medication/s Statin+ e mycin Penicillin Lithium toxic Pamidronate Citalopram Meropenem +valproate Strontium

28 Disease or ADE & preventable? Patient presents Rhabdomyolysis Anaphylaxis Stroke Acute on chronic renal injury Arrhythmia Seizure DVT Medication/s Statin+ e mycin Penicillin Lithium toxic Pamidronate Citalopram Meropenem + valproate Strontium Prevention strategy Check for interacting medications, patients at risk Accurate allergy documentation Medication reconciliation to check dose Contraindicated in renal disease At risk patients for QT interval Check valproate levels Do not prescribe in at risk patients i.e. immobile, history DVT

29 Adverse drug reactions (ADRs) ADRs= adverse drug events with causal link to a drug around 5% of hospital admissions (range: 0.3%-11%) fatal in up to 3 in 1000 medical inpatients ADRs complicate drug therapy decrease compliance delay discharge increase costs

30 ADR drug interaction: case 62 year old treated with multiple antibiotics for TB Rx Isoniazid, Rifampicin, Fusidic acid Also being treated for AF with warfarin 4mg Interaction? rifampicin increases the metabolism and clearance of warfarin, resulting in reduced anticoagulant effects Warfarin dose increased to 12mg TB course completed after 9 months problem?

31 Rifampicin + warfarin Several weeks after ceasing TB meds fell off a chair Found to have extensive bruising In ED: INR>>20 CT scan brain NAD Hb 72 Treatment Rx warfarin ceased, Vitamin K, 5 units PC Issues Drug Interaction- ceasing rifampicin increased warfarin effect No INR monitoring- lack of plan Upon discontinuation of rifampicin, the dose of warfarin should have been reduced to about one fifth. Because of large variation in warfarin response, need to monitor INR and adjust the dose when stopping or starting a new medication

32 Medication safety and drug interactions 1. Use a personal formulary a selection of medications and knowing them well 2. Know the most commonly interacting medicines in your practice Rifampicin Methadone Warfarin Tramadol Statins Fluconazole 3. Review all medications when adding or ceasing a medication 4. Check interaction databases

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34 Safer prescribing, dispensing, administration Errors in transition; using Med Rec Getting the 6 rights

35 Residential care Inpatient hospital order How to prevent errors in transition?

36 Aim: Decrease medication errors during admission, at discharge or transfer Medications mix-up at transfer of care one medication omitted from history for every two patients admitted one in six regular medications omitted from discharge prescriptions Intended medication regimen differs from that prescribed at discharge CHECK Tam VC, Knowles SR et al, CMAJ 2005 Gleason KM, McDaniel MR et al, J Gen Intern Med Feb 2010 Cornish PL, Knowles SR, Archives Int Med 2005 Easton K., et al. (2008). Medication safety in the community: A review of the literature. Sydney, National Prescribing Service

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38 Medication Reconciliation 1. A formal process of obtaining and verifying a complete and accurate list of patient's current medicines. 2. Matching the medicines the patient should be prescribed to those they are actually prescribed. 3. Any discrepancies are discussed with the prescriber and reasons for changes to therapy are documented Involving the patient and carer in information transfer Bring in meds to hospital and clinics Having an up-to-date med list Having one GP and pharmacy and knowing their contact numbers Documenting allergies/ adverse effects

39 Medication Reconciliation: Case 58 year old patient Rx rifampicin + fusidic acid for recurrent MRSA Presents with rash, joint pains, sweats, insomnia DDx adverse drug reaction to rifampicin Review full medication history Rx methadone 10mg tds for joint pain & PRN naproxen Drug interaction? Dx Methadone withdrawal precipitated by rifampicin Rifampicin induces methadone metabolism. Methadone dose/frequency will need to increase every couple of days. May need double the methadone dose while on rifampicin AND Decrease methadone dose gradually when rifampicin ceased

40 The six rights 1. Right drug Use generic name, check dose Incorrect dose for the drug Patient not on Xanax (= alprazolam ) intended drug was?

41 2. Right dose Avoid abbreviations 3. Right route

42 4. Right patient 5. Right time PRN narcotics require a maximum dose

43 6. Right scenario

44 Medication Safety: Prescribing 1. Reconcile all medications when patients are transferred from home to hospital and back 2. Regularly review all medications prescribed check interactions, update adverse reactions, discuss with patient/carer 3. Avoid error prone abbreviations, clarify decimals e.g. daily (not OD), subcut ( not sc), units (not U). 0.5 NOT.5 4. Use generic name to avoid look alike/sound-alike names e.g. cephalexin vs. Keflex? vitex lipex ibilex ialex ilex 5. Indicate clearly if a medication is controlled release e.g. Oxycodone: OxyCONtin or Endone?.electronic prescribing has fixed all this

45 Computer generated prescriptions still need checking!

46 QUM in summary 1. Correct drug for correct diagnosis 2. Appropriate dose clearly prescribed, dispensed and communicated to the patient and carer 3. Have a formulary for your own important medications 4. Avoid overuse (e.g. antibiotics) 5. De-prescribe inappropriate drugs (sedatives, opiates) 6. Avoiding interactions, withdrawal effects on discontinuation 7. Consider of cost

47 Questions and comments National Medicines Policy & QUM Extent of medication use Medication safety issues Avoiding harm: Adverse Drug Events (ADE) & ADRs Drug Interactions Resources Problems in transition; using Med Rec Getting the 6 rights

48 Useful Resources TGA National Medicines Policy PBS ADR reporting NPS Australian Prescriber RADAR MIMs Consumer Medication Information Product Information Drug interactions Don t Rush to Crush Australian Commission for Quality and Safety in Health Care Eastern Metropolitan Region Palliative Care Consortium Opioid Conversion Ratios, Syringe Driver compatibilities Therapeutic Guidelines; Palliative Care

49 Useful Resources- overseas ISMP NICE National Institute for Health and Clinical Excellence (UK)- an independent organisation responsible for providing national guidance on promoting good health and preventing and treating ill health. Cochrane Collaboration The Cochrane is an international, independent, not-for-profit organisation of over 28,000 contributors from more than 100 countries, dedicated to making up-to-date, accurate information about the effects of health care readily available worldwide. Considered world leaders in evidence-based health care e.g. Interventions for enhancing medication adherence