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Managing high risk medicines in primary care

Aim

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

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5000000

10000000

15000000

20000000

25000000

30000000

35000000

40000000

45000000

2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

Increase in prescription items over 10 year period

Total

Risk associated with prescribing

•  Approximately 7.5% of Rx in general practice contain an error (Shah et al., 2001)

•  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)

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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 2012/13 38.7 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?

High risk medicines

•  Anticoagulants e.g. warfarin, dabigatran •  Antiepiletics •  Digoxin •  Opioids •  Methotrexate •  Antipsychotics

•  Cardiovascular drugs e.g. beta-blockers, diuretics

•  CDs •  Red list medicines •  Amiodarone •  Lithium •  Insulin

High risk medicines

•  Methotrexate

•  Lithium

•  Warfarin

•  Opioids

•  Liquid Paraffin

•  Insulin

Methotrexate

NPSA 2006: Improving compliance with oral methotrexate guidelines

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

Apr-08 Apr-09 Apr-10 Apr-11 Apr-12

Item

s

Methotrexate

NICE GUIDELINE CG79 Rheumatoid

Arthritis 2009

Methotrexate Rx items per month in NI

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Methotrexate: Local incidents

•  Communication issues

-  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: Local incidents

•  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 2009 -2013

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

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Lithium NPSA 2009: Safer lithium therapy

Lithium: Local issues

•  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

Lithium patients

Pathway 1: Secondary care

review and monitoring

Pathway 2: Secondary care

review, monitoring by

GP. Pathway 3:

GP review and ongoing

monitoring

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

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Warfarin NPSA 2007: Actions that can make anticoagulant therapy safer

Warfarin: NPSA recommendations

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

1. Warfarin protocols: Local incidents

•  Patient on warfarin for AF

•  Usual dose 6mg daily

•  Admitted to hospital for pacemaker, warfarin stopped

•  Patient discharged before INR in range

•  CDSS used to calculate dose in GP practice

1. Warfarin protocols: Practice actions

•  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

2. Warfarin and MDS: Local incidents

•  Patient on warfarin

•  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: Practice actions

•  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

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3. Warfarin interactions: Local incidents

INR Age Drug Diagnosis

13.1 89yr 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: Practice actions

•  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 NPSA 2008: Reducing dosing errors with opioid medicines

Strong opioids: Local incidents

•  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: Practice actions

•  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: Practice actions

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 <370 degrees -  Store and dispose of safely

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Liquid paraffin NPSA 2007: Fire hazard with paraffin-based skin products

Liquid paraffin containing products

•  708,000 emollients prescribed per annum •  These usually contain a ‘paraffin’ ingredient

Liquid paraffin: Practice actions

•  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:

Local incidents •  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

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Insulin: Local incidents

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

Insulin: Practice actions

•  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 http://www.kingsfund.org.uk

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

High risk combinations of medicines

•  K salt or K sparing diuretic (excluding spironolactone/eplerenone) and ACEi/ARB

•  Verapamil and beta-blocker

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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: Practice actions

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

Adverse drug reactions: Yellow Card Scheme

•  Introduced in 1964 •  25,000 reports per year •  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

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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

Adverse drug reactions: How to report

Online •  http://yellowcard.mhra.gov.uk/ •  Drop down menus •  Also electronic reporting on GP clinical

systems

Paper •  Access form via the BNF •  Download from https://yellowcard.mhra.gov.uk •  Return FREEPOST

Medication incidents: Information to record

•  What went wrong

•  Contributory factors

•  What action was taken

•  What can be done to prevent reoccurrence

Medication incidents: How to report

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