Aim. Managing high risk medicines in primary care. Intended outcomes. Introduction. Risk associated with prescribing
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- Winfred Fields
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1 Aim Managing high risk medicines in primary care To increase awareness of high risk medicines and combinations of medicines and to ensure the appropriate prescribing, supply or administration of such in primary care. Intended outcomes Appreciate the range of high risk medicines used within primary care Understand the specific risks associated with particular drugs and drug combinations Identify strategies to reduce the risk associated with the use of these drugs and drug combinations in practice Contribute to pharmacovigilance by appropriately reporting medication incidents and adverse effects Introduction Growing and ageing population Increasing demands on NHS Increasing demands on all HCPs Increasing number of drugs available Increased prescribing and dispensing More drug products/combinations to select Increased RISK Increase in prescription items over 10 year period Risk associated with prescribing Approximately 7.5% of Rx in general practice contain an error (Shah et al., 2001) Total In a practice of 1,000 patients aged > 65 years: 14 preventable adverse drug events per year 5 serious (Gurwitz et al., 2003) Approximately 1 in 25 hospital admissions are drug-related and preventable (Howard et al., 2007)
2 Risk associated with dispensing Ashcroft and colleagues (2005) report dispensing incidents occur at a rate of 26 per 10,000 dispensed items 26 incidents include 22 near misses and 4 dispensing errors In NI in 2012/ million items were dispensed 10,0620 per year 1,935 incidents per week 297 errors per week 1,636 near misses per week What drugs or drug combinations provide the most challenges to you when prescribing/supplying? Anticoagulants e.g. warfarin, dabigatran Antiepiletics Digoxin Opioids Methotrexate Antipsychotics High risk medicines Cardiovascular drugs e.g. beta-blockers, diuretics CDs Red list medicines Amiodarone Lithium Insulin Methotrexate Lithium Warfarin Opioids Liquid Paraffin Insulin High risk medicines Methotrexate Rx items per month in NI Methotrexate NPSA 2006: Improving compliance with oral methotrexate guidelines Items 7,000 6,000 5,000 4,000 3,000 2,000 1,000 NICE GUIDELINE CG79 Rheumatoid Arthritis Apr-08 Apr-09 Apr-10 Apr-11 Apr-12 Methotrexate 2
3 Communication issues Methotrexate: - Dose was changed to 2.5mg weekly but script was issued for 25mg weekly - Hospital letter was not clear about dose change to 5mg weekly and the script was repeated for the old dose of 7.5mg weekly Methotrexate: Non-adherence to regional policy - Dose required was 10mg weekly - Prescribed as 10mg and not 4 x 2.5mg tablets - Pharmacy dispensed 10mg - Error occurred twice before it was noted Incorrect labelling - Prescribed dose 10mg (4 x 2.5mg) - Labelled as 20mg (4 x 2.5mg) Methotrexate 10mg Items per month Methotrexate: General practice actions Prescribe in multiples of 2.5mg tablets, ONCE WEEKLY on specific day (not Monday) Avoid as required or as directed Arrange and record on-going monitoring as agreed with specialist Shared care guideline Methotrexate: General practice actions Regular review of all prescriptions for methotrexate Ensure any 10mg tablets have been risk assessed Check quantities prescribed Review HSCB methotrexate guidance HSCB methotrexate audit Methotrexate: Pharmacy practice actions SOP for dispensing methotrexate Query new prescriptions for: Methotrexate 10mg tablets Large quantities Be aware of: Signs of methotrexate toxicity Drug interactions e.g. trimethoprim 3
4 Lithium: Local issues Lithium NPSA 2009: Safer lithium therapy Insufficient monitoring - Lithium levels every 3 months - U&Es and TFT every 6 months - BMI every 12 months - Side effects and mood changes - regularly Poor communication - Primary/secondary - Clinician/patient Inadequate patient education Lithium Therapy Information Pack Pathway 1: Pathway 2: Secondary care review, monitoring by GP. Pathway 3: Secondary care review and monitoring GP review and ongoing monitoring Lithium patients Lithium: General practice actions Clear Patient Pathway Systems: Regular review and monitoring Communication of results Use of communication proforma Patient education e.g. NPSA Patient Information Update of Record Book Lithium: Pharmacy practice actions Patient education Regular monitoring Safe to dispense Identify drugs which may potentially interact with lithium 4
5 Warfarin: NPSA recommendations Warfarin NPSA 2007: Actions that can make anticoagulant therapy safer 1. Review and/or update written procedures and clinical protocols to ensure they reflect safe practice 2. Promote the use of written safe practice procedures for the administration of anticoagulants in social care settings (MDS) 3. Promote safe practice for co-prescribing one or more clinically significant interacting medicines Patient on warfarin for AF Usual dose 6mg daily 1. Warfarin protocols: Admitted to hospital for pacemaker, warfarin stopped Patient discharged before INR in range CDSS used to calculate dose in GP practice 1. Warfarin protocols: GP should review hospital discharge information to identify any warfarin issues GP should review dose and INR frequency manually during initial period following hospital discharge until within therapeutic range All HCPs should ensure patient/carer knowledge is checked regarding dose Patient on warfarin 2. Warfarin and MDS: Usual dose 6mg daily included in MDS Warfarin had been omitted from the MDS prepared by locum - Usual practice was to add in warfarin once GP confirmed INR and dose Patient suffered a pulmonary embolism 2. Warfarin and MDS: GP must assess the risk in conjunction with pharmacist, patient/carer GP Practice & Pharmacy protocol Agree how dose changes will be managed on the day they are needed How a record of the dose change and INR will be communicated to the pharmacist How a record of the dose change and INR will be communicated to the patient/carer How the contents of the box will be changed before the next dose 5
6 3. Warfarin interactions: INR Age Drug Diagnosis yr Clarithromycin Cellulitis 12 89yr Flucloxacillin Metrondiazole Cellulitis 15 61yr Amoxicillin LRTI >10 79yr Amoxicillin LRTI >8 99yr Prednisolone LRTI 5 61yr Diclofenac Gout 3. Warfarin interactions: Prescribing safety indicators E.g. King s Fund or warfarin audit Process for informing patient and clinic of interaction and arranging INR Pharmacist needs to check INR and date of next test when dispensing Patient education Effect of medicines and illness Strong opioids: Strong opioids NPSA 2008: Reducing dosing errors with opioid medicines Selection errors - Mezolar 75mcg and 25mcg patches - MST 100mg and 10mg - MST 60mg and 10mg Mix ups - Generic prescribing e.g. MST / Sevredol - High/low strength ampoules e.g. Oxycodone Accidental exposure to Fentanyl patch Strong opioids: Clearly separate similar products Ensure doses are safe and appropriate Confirm recent opioid doses and other analgesia Dose increases not greater than 50% of previous dose care with conversion calculations Familiarise with opioid characteristics Advise patients on signs of overdose Prescribe modified-release CDs by brand name When dispensing/administering, a second check should be carried out Naloxone carry for reversal of opioid overdose Strong opioids: Fentanyl patches - advise patients on safe use - Apply every 72 hours - remove old patches first - Avoid touching adhesive - Do not cut patches affects release/product licence - Mezolar C/I if allergy to peanuts/soya - Avoid heat sources on application area - Patients with fever should be monitored - Patients should bathe in temperature <37 0 degrees - Store and dispose of safely 6
7 Liquid paraffin containing products Liquid paraffin NPSA 2007: Fire hazard with paraffin-based skin products 708,000 emollients prescribed per annum These usually contain a paraffin ingredient Liquid paraffin: All patients prescribed/dispensed 100g or more of paraffin based products should be advised about: Potential fire risks, exposure to smoking or open flame Changing bedding or clothing Use NPSA patient information leaflet Insulin 1. NPSA 2010: Safer administration of insulin 2. NPSA 2011: The adult patient s passport to safer use of insulin N. Ireland resources Insulin: Dosing Errors from use of abbreviation of the term unit 4U has been interpreted as 40 units Administration Errors due to the use of intravenous syringes to measure and administer insulin Patient received 60 units of Actrapid when 0.6mls measured using an IV syringe instead of correct dose of 6 units 7
8 Insulin: Insulin: Insulin prescribed Insulin dispensed Levemir Innolet Insulatard Innolet Humalog Mix25 Humalog short acting Humulin M3 Humalog Humulin M3 Kwikpen Humalog Humalog Mix 50 Kwikpen Humalog 3ml Kwikpen Novorapid Flexpen Novorapid cartridges Adult patients on insulin therapy to receive: Patient information booklet Insulin Passport (medication card) Refer to Insulin Passport as a safety check when insulin is prescribed dispensed or administered Never abbreviate units to iu Insulin: Pharmacy practice actions Storage of insulin products Do not overcrowd fridge Do not store food in fridge Separate similar sounding/looking products from each other Keep dispensed medicines waiting collection separate from stock Fridge temperatures should be monitored and recorded daily High risk combinations of medicines: Ensuring safer practice An enquiry into the quality of GP prescribing in England. Maximising effectiveness Minimising risks Minimising costs Respecting patients choices High risk combinations of medicines High risk combinations of medicines Warfarin and oral NSAID Phosphodiesterase type-5 inhibitor (e.g. sildenafil) and nitrate or nicorandil Clarithromycin/erythromycin and simvastatin with no recorded advice to stop simvastatin during the course of antibiotic K salt or K sparing diuretic (excluding spironolactone/eplerenone) and ACEi/ ARB Verapamil and beta-blocker 8
9 High risk patient groups Elderly, particularly when frail Multiple serious morbidities taking several potentially hazardous medications Acute medical problems Ambivalent about medication-taking or have difficulty understanding or remembering to take medication. Practice systems: What can you do to improve the safety of medicines use for patients? Practice systems: 1. Medication Review - QOF - MURs (pharmacy) - High risk combination reviews 2. Protocols Adverse incidents Acute and repeat prescribing Dispensing High risk medicines 3. Good communication Reporting adverse drug reactions and medication incidents Introduced in ,000 reports per year Adverse drug reactions: Yellow Card Scheme 2008 website re-launched to allow easier reporting Who can report? Doctors Pharmacists Nurses Midwives Patients Carers Dentists Coroners Health visitors Adverse drug reactions: What to report Serious adverse drug reactions Involving drugs in the additional monitoring (black triangle) scheme Involving a child You do not need to prove causality Include licensed or off-label use 9
10 Adverse drug reactions: Information to record Yellow card needs 4 essential pieces of information: Name of the medicine Description of the reaction Patient details Reporter details Online Drop down menus Adverse drug reactions: How to report Also electronic reporting on GP clinical systems Paper Access form via the BNF Download from Return FREEPOST Medication incidents: Information to record Medication incidents: How to report What went wrong Contributory factors What action was taken What can be done to prevent reoccurrence GP Practices Initial review of an incident may be through significant event analysis in the GP practice AIF1 Form on primary care intranet to share with HSCB Pharmacy Incidents are reviewed within the pharmacy Incident log Shared with HSCB either anonymously or by pharmacist Information on anonymous reporting on HSCB website Learning resources Intended outcomes Appreciate the range of high risk medicines used within primary care Understand the specific risks associated with particular drugs and drug combinations Identify strategies to reduce the risk associated with the use of these drugs and drug combinations in practice Contribute to pharmacovigilance by appropriately reporting medication incidents and adverse effects 10
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