TOWARDS SAFER PRESCRIBING IN WALES: A PROGRESS REPORT

Philip A Routledge

AWMSG 15th Anniversary Conference, Cardiff, June 27- 28th 2017

44

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Am J Public Health Nations Health. 1968; 58: 1431-8.

FactorsPhases

Human Factors Medicine Environment

Pre-event Education(of future health professionals in

patient/medication safety)

Engineering(e.g. Algorithms, checklists,

Robots)

Engineering(e.g. Single national inpatient

prescription chart)Economic Incentives

Enforcement

Event Engineering (safer systems)

Engineering(e.g. Clearer labelling and

Barcoding)

Engineering(e.g. Decision Support Systems

systems)

Post-event Education (of patients in recognising/

assessing and helping to prevent ADEs)

Engineering(e.g. Production of effective

antidotes)

Engineering(timely access to advice)

Enforcement

Haddon Phase-factor matrix interventions to improve medication safety

Adapted from: Budnitz DS and Layde PM. Outpatient drug safety: new steps in an old direction. Pharmacoepidemiol Drug Saf. 2007;16:160-5

Prescribing Indicators• “Quantitative measures of prescribing that can be used to

estimate the quality of prescribing and enable comparisons to be made between prescribers, regions and countries”

• “One of the main ways in which prescribing indictors are used is to enable peer pressure to influence prescribers’ behaviour”

• “Prescribing indicators can provide some data about whether prescribing practices have changed, but they are simply derived from information about what has been prescribed, not why”

”Medicines management” by Janet Krska and Brian Godman in ”Pharmacy and Public Health” Edited by Janet Krska, Pharmaceutical Press, London 2011

2013/14 2014/15 2015/16 2016/17

Low strength inhaled corticosteroids(ICS) (% of all ICS prescribing)

38 38 38 59

Hypnotics & anxiolytics (ADQs/1,000 STAR-PUs)*

3905 3642 3358 3135

NSAIDs(ADQs/1,000 STAR-PUs)* 1854 1775 1659 1546

Tramadol(DDDs/1,000 patients)

788 708 665 631

National Prescribing Indicators (NPIs)i of ii

√

√

√

√2016-17 data subject to final confirmation

2013/14 2014/15 2015/16 2016/17

Antibiotics(items/1,000 STAR-PUs)* 374 377 362 337

Quinolones(% of antibacterial items) 2.04 1.85 1.75 1.86

Cephalosporins(% of antibacterial items) 4.42 3.56 3.17 3.06

Co-amoxiclav(% of antibacterial items) 4.55 3.97 3.45 3.32

National Prescribing Indicators (NPIs)ii of ii

√

√

√

×

2016-17 data subject to final confirmation

Interactive case-based learning

1. E is for “Education”

Dosulepin prescribing• Tricyclic antidepressant, historically used where anti-anxiety/ sedative

effect required, but small margin of safety between maximum therapeutic dose & potentially fatal doses1

• The MHRA Drug Safety Update in December 2007 reported that dosulepin continued to be prescribed widely and accounted for about 10% of the antidepressant market in England1

• The updated NICE Clinical Guideline (CG90) “Depression: the treatment and management of depression in adults” in 2009 strengthened the previous advice, stating that “dosulepin should not be prescribed” 2

1. Drug Safety Update: Volume 1, Issue 5, December 2007. Available at: http://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/CON2033216 Accessed 11 August 2010.2. National Institute for Health and Clinical Excellence. Clinical Guideline 90. Depression: the treatment and management of depression in adults; October 2009. Available at: http://guidance.nice.org.uk/CG90

http://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/CON2033216http://guidance.nice.org.uk/CG90

MHRA Advice (2007)NS

NICE advice (2009)NS

AWMSG NPI (2011) p=0.001

Trends in dosulepin dispensing

Deslandes PN, Jenkins KS, Haines KE, Hutchings S, Cannings-John R, Lewis TL, Bracchi RC, Routledge PA. A change in the trend in dosulepin usage following the introduction of a prescribing indicator but not after two national safety warnings.

J Clin Pharm Ther. 2016 ; 41:224-8

2. E is for “Engineering”

•Standardised charts•Algorithms•Decision support systems•Checklists•Electronic prescribing•Electronic ADR reporting•Smartphones & Apps etc.

Warfarin

Day International Normalised

Ratio Preferable (Measured 9 to 10 am)

Warfarin Dose Preferable given at 5 - 6 pm

(milligrams)

1

< 1.4

10.0

2

< 1.8

1.8 > 1.8

10.0 1.0 0.5

3

< 2.0 2 - 2.1

2.2 - 2.3 2.4 - 2.5 2.6 - 2.7 2.8 - 2.9 3.0 - 3.1 3.2 - 3.3

3.4 3.5

3.6 - 4.0 > 4.0

10.0 5.0 4.5 4.0 3.5 3.0

2.5 2.0 1.5 1.0 0.5 0

Predicted Maintenance Dose (Milligrams

4

< 1.4

1.4 1.5

1.6 - 1.7 1.8 1.9

2 - 2.1 2.2 - 2.3 2.4 - 2.6 2.7 - 3.0 3.1 - 3.5 3.6 - 4.0 4.1 - 4.5

> 4.5

> 8.0 8.0 7.5 7.0 6.5 6.0 5.5 5.0 4.5 4.0 3.5 3.0

Miss out next day’s dose then give 2 milligrams Miss out 2 day’s doses then give 1 milligram

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Warfarin

Day

International Normalised

Ratio Preferable

(Measured 9 to 10 am)

Warfarin Dose

Preferable given at 5 - 6 pm

(milligrams)

1

< 1.4

10.0

2

< 1.8

1.8

> 1.8

10.0

1.0

0.5

3

< 2.0

2 - 2.1

2.2 - 2.3

2.4 - 2.5

2.6 - 2.7

2.8 - 2.9

3.0 - 3.1

3.2 - 3.3

3.4

3.5

3.6 - 4.0

> 4.0

10.0

5.0

4.5

4.0

3.5

3.0

2.5

2.0

1.5

1.0

0.5

0

Predicted Maintenance Dose

(Milligrams

4

< 1.4

1.4

1.5

1.6 - 1.7

1.8

1.9

2 - 2.1

2.2 - 2.3

2.4 - 2.6

2.7 - 3.0

3.1 - 3.5

3.6 - 4.0

4.1 - 4.5

> 4.5

> 8.0

8.0

7.5

7.0

6.5

6.0

5.5

5.0

4.5

4.0

3.5

3.0

Miss out next day’s dose then give 2 milligrams

Miss out 2 day’s doses then give 1 milligram

Study (year) Study Design Setting Intervention Comparison Outcomemeasure

Result

Coombes et al. (2009)

Prospective cohort

Ward (5 hospitals)

State-wide standardised medication chart

Non-standardised charts used previously

Prescribing errors

Decrease in prescribing errors

Coombes et al. (2011)

Prospective cohort

Ward (22 hospitals)

national standardised medication chart

Non-standardised charts used previously

Prescribing errors

Decrease in prescribing errors

Standardized in-patient medication chart

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3. E is for “Economics”• Safe prescribing incentives (e.g. national

prescribing indicators [NPIs])

• Clinical Effectiveness Prescribing Programme (CEPP)

• Reporting incentives (e.g. CPD & revalidation)

• Measures of esteem and recognition

Yellow Card National Reporting Indicator (NRI)

• The target for GP practices in Wales is to submit one yellow card per 2,000 practice population for the year

• The target for the health board is to submit yellow cards in excess of one per 2,000 health board population

• This would mean an extra 150 yellow cards from GPs in Wales, 50% more than in 2013-14

Reporting by General Practitioners to the UK Yellow Card Scheme (2013-14 & 2014-15)

Yellow Card Centre Wales, a regional reporting centre of the Medicines and Healthcare Products Regulatory Agency (MHRA)

Number of Yellow Cards from GPs in

2013-14

Number of Yellow Cards from GPs in

2014-15

Percentage increase

Wales 274 664 +142%

England 3,629 4,232 +17%

Deslandes P et al. Unpublished data

0

2

4

6

8

10

12

14

16

18

20

2011

/12

Q1

2011

/12

Q2

2011

/12

Q3

2011

/12

Q4

2012

/13

Q1

2012

/13

Q2

2012

/13

Q3

2012

/13

Q4

2013

/14

Q1

2013

/14

Q2

2013

/14

Q3

2013

/14

Q4

2014

/15

Q1

2014

/15

Q2

2014

/15

Q3

2014

/15

Q4

Num

ber o

f rep

orts

per

100

,000

pop

ulat

ion ABMU Aneurin Bevan BCU

Cardiff and Vale Cwm Taf Hywel Dda

PowysIntroduction

of NRI

4. E is for “Enforcement”

• Suspension/ revocation marketing authorisation (MA)• Change in legal status (e.g. P to POM)

• Constraints and barriers• Failure Mode Effects Analysis (FMEA) and self-

assessments• Forcing functions and Fail-Safes• Centralise error-prone processes• Maximise access to information (e.g. advisory warnings)• Standardise and Simplify

http://www.ismp.org/Newsletters/acutecare/showarticle.aspx?id=45

Adapted from “Your high-alert medication list—Relatively useless without associated risk-reduction strategies”

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Trends in tramadol prescribing (2011-2015)

ACMD notice

WeMeReC module 1

AWMSG resources

WeMeReC module 2

AWMSG NPI

Class C

WCPPE

5. A commitment to “Excellence”A Proposal: An Institute of Medicines Safety and Improvement should be established in Cardiff and Vale University Health Board to:-

• promote effective collaborations using co-production principles to implement improvements and enhance patient safety

• act as a focus for education and training in medicines safety for the NHS and the pharmacy, nursing, PAM and medical schools in Wales

• act as a forum to promote partnerships in research and development, including multi-professional approaches to ensuring the best experience of medicines for patients

15-year report (2002-2017)

• Medicines safety in Wales can continue to benefit from a study of approaches to improving other aspects of safety

• “Education”, “Engineering” “Economics” and “Enforcement” are four valuable tools to support continuing improvement

• A commitment to “Excellence” and a willingness to change the culture are positively transformational

Acknowledgements• All Wales Medicines Strategy Group and its subgroups• All Wales Therapeutics and Toxicology Centre• All Wales Chief Pharmacists Committee and sub-groups• Welsh Medicines Information Centre• Royal Pharmaceutical Society (RPS) and RPS Wales• Welsh Government’s Patient Safety Wales team• 1000 Lives Improvement • Universities in Wales • Bevan Commission• Medicines and Healthcare Products Regulatory Agency (MHRA)• National Institute of Health and Care Excellence (NICE)

Diolch yn fawr

routledgepa@cardiff.ac.uk

23

TOWARDS SAFER PRESCRIBING IN WALES: A PROGRESS REPORT�Slide Number 2Slide Number 3Slide Number 4Slide Number 5Slide Number 6Slide Number 7Slide Number 8Slide Number 9Dosulepin prescribingSlide Number 112. E is for “Engineering”Slide Number 13Slide Number 14Yellow Card National Reporting Indicator (NRI)Slide Number 16Slide Number 174. E is for “Enforcement”Slide Number 19Slide Number 2015-year report (2002-2017) AcknowledgementsSlide Number 23