ball implementation inspiration feb 2006[1]

8/6/2019 BALL Implementation Inspiration Feb 2006[1]

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InspiRaTI

onConsensus Forum

13 February 2006Cairo, Egypt


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Peter BallUniversity of St Andrews,

Scotland

Practical Issues:

Implementing

principles I


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Wise et al. BMJ 1998; 317:609671

Calls to action:24 articles on resistance

(Lancet 1998) Window between drug discovery and appearance of resistanceis shortening Indiscriminate attempts to sterilize the environment (Levy)

Community = 85% : 80% = RTI (Huovinen & Cars)

free return visits for no Rx

18 hours F/U for acute otitis media

Prudent animal usage benefits society (McKellar)

Must reduce both prescription frequency and duration (Wiseet al.)

Political: little effect on Rx, none on resistance (Carbon & Bax)

Behavioural aspects:

care of the elderly paediatric day care

Accurate surveillance essential (Livermore et al.)

We are running out of time and need to act now (Krag)


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Consensus Group 2002onwards

Principles of appropriate prescribing:

TREAT bacterial infection only

OPTIMIZE diagnosis / severity assessment MAXIMIZE bacterial eradication (or load reduction)

RECOGNIZE(local) resistance prevalence

UTILIZE PD effective choice of agent and dose

INTEGRATE local resistance, efficacy and cost-effectiveness

Ball et al. Antibiotic therapy of community respiratory tract infections: strategies for optimaloutcomes and minimized resistance emergence. J Antimicrob Chemother 2002; 49:3140


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What are we trying to do?

Prevent (or reduce prevalence of)increased bacterial resistance

By improving the quality of prescribing

reducing inappropriate prescribing

optimizing appropriate prescribing

Targeting RTI and primary / out-patientclinical care

via governments, health-care providers,doctors (societies), patients, media

Reducing overall costs

to the health-care system (repeat Rx andconsultations, tests, hospital)

to patients


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Steps to implementation andaudit plus feedback

CORE CONSENSUS:

REVIEW DATABASE

Surveillance of resistance

and usageAssess costs and outcomes

Formulate and illustratePrinciples

Publish

Identify and meet regional

experts

REGIONAL CONSENSUS:

ASSESS RELEVANCE OFPRINCIPLES

Review existing localinitiatives

Interface with principles

Local surveillance data

Implementation -

methodology and barriersLOCALCONSENSUS:

RECRUITADVOCATES

Education campaign

Pilot implementationFeedback prior to


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Antibiotic usage in SouthAfrica

Data from IMS 2003

Totalunits

in000s

0

500

1000

1500

2000

2500

3000

3500

4000

4500

5000

1998 1998 2000 2001 2002 2003

Broad penicillins

Cephalosporins

Quinolones

Macrolides

Trimethoprims

Med/narrow pen


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Total antibiotic usage influencesresistance rates:higher usage = higher resistanceprevalence100

Frequ

enc

y(%)

Time (weeks)

100 200 300 400 10009008007006005000

0

20

40

60

80

50DDDs/1000

25

DDDs/1000

Austin et al. Proc Natl Acad Sci USA 1999; 96:11521156


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Middle East and Africa:penicillin-resistant S.

pneumoniae

Egypt29.1% 0.0%

SouthAfrica

20.9%51.0%

Kenya41.2% 1.8%

Nigeria36.0%

Ghana17.0% 0.0%

Lebanon

38.0% 18.0%Kuwait

1.6% 45.6%Tunisia

24.0% 11.0%

Algeria11.4% 5.7%

Turkey26.8%18.3%

Penicillin-intermediate (MIC 0.121 gPenicillin-resistant (MIC 2 g/mL)

Data from various sources and various years

Israel16.9% 29.7%

Saudi Arabia39.8% 21.7%


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Resistance in Africa-MiddleEast region

S. pneumoniae pen I/R

Cairo pen I/R: 63% El Kholy et al. 2003

Saudi Arabia: 24% I/R, 1.7% R Rahman et al. 1999

Saudi Arabia: 4051% I/R, 622% R Shibl et al. 2000; Jacobs 2003

Turkey (Istanbul): 525% I/R, 09% R Gr et al.

2002 Turkey (UNI): 84% I/R, 16% R Inar et al 2004

South Africa: 2430% I/R, 4650% RLiebowitz 2003; Baskett study

Nigeria: 93% (92% to Co-Trim) Habib et al, 2003

Kenya: 48% I/R (~80% Co-Trim) Revathi 2003

S. pneumoniae ERY 58-61% (ermB 75%)Liebowitz 2003; Baskett study

S. pneumoniae LEVO 16 mg/L (x 1 isolate) Ak et al. 2002 (Turkey)


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Resistance mirrors usage:individuals, specific populations,regions, countries INDIVIDUALS (Gustafsson et alJAC 2003,52:645-50)

CF, haematology patients vs 1 care controls:

CEF / ERY resistance 50-60% ~ 0% in controls REGIONAL POPULATIONS (Garcia-Rey et alJ Clin Microbiol

2002; 40:159-64) Usage mirrors -lactam/macrolide resistance in Spain

LA macrolides and oral cephalosporins specially implicated

Correlation coefficients 0.75-0.85 (p 0.003)

SPECIFIC POPULATIONS (Fry et alCID 2002; 35:395-402)

Mass prophylaxis of trachoma in Nepalese children

After one exposure NP Pn resistance 0%: after two exposures 4.3%

COUNTRIES FINLAND (Seppl et al. NEJM 1997;337:441446)

DDD/1000 macrolides: 2.4 reduced to 1.4 in 1990s

macro-R gpA strept: 16.5% reducing to 8.6% over the period


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Will restriction to appropriateuse (principle compliance)

reduce resistance prevalence? Icelandic experience RTIYES!

Swedish experience RTI

YES (but slowly)

Finnish experience RTI (Seppl et al, NEJM1997)

YES

DDD/1000 macrolides: 2.4 reduced to 1.4 in 1990s

macro-R gpA strept: 16.5% down to 8.6% over theperiod

Conversely: RTI (Pihlajamki et al, 2001)

Increased use = increased resistance


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Pressures on the primary-carephysician

Peer groups / prescribing and pharmacyadvisors

Hospital experts, formularies and guidelines

Pharmaceutical

representatives

(Industryspends 35%of profits onmarketing)

Regulatorycontrolmechanisms

Patients

demands

and

physicianaspiration

s


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Why dont physicians followRTI guidelines?

Barriers to implementation include lack of:

Awareness / familiarity TOO MUCH INPUT

Agreement: between guidelines MANYCONFLICTS

Time and motivation I AM TOO BUSY

Credibility (applicability and practicability)WHICH EXPERTS

Proven outcome benefit BENEFIT TO WHO?

to patient and PC physician PROVE IT!

Industry spends 35% of income on promotion

Cabana et al. JAMA 1999; 282:1458Monnet & Sorenson. Clin Microbiol Infect 2001; 7(s6):2730


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Are practice guidelines usefulin practice?

Italian physicians (2001 survey) perceived practiceguidelines as:

externally imposed, cost-containment tools 76%

NOT as decision-supporting tools

Applicability to their practice:

too rigid for individual patients 61%

inflexible for local situations 59%

Guidelines are MOST useful if:

Produced by a team: specialists AND primary care (i.e. theusers!)

Guidelines more useful (% responding YES) than:

Personal experience (6%), Journals (10%), conferences (6%)

Pharmaceutical reps (72%)

Formoso et al. Arch Intern Med 2001; 161:20372042


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Primary care prescribinginformation sources 1990s

Huchon et al. Eur Respir J 1996; 9:15901595

010

20

30

40

50

60

70

80

90100

Medical schoolMedical journalsPostgraduateteaching

Pharmaceuticalcompanies

Nationalguidelines

UK Spain Italy


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Where do patients getinformation (Taiwan)?

Who should provide education about antibiotics? (% totalresponse)

Physicians 70

Pharmacists 54.5

Public health officers 50

Nurses 35

Teachers 35

Mass media 62

45-50% thought antibiotics = anti-inflammatory /antipyretic agents

92% thought taking less than the full course was morehealthy

Chen et al, J Microbiol Immunol Infect 2005; 38:53-9


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Cochrane reviews: methods ofchanging practice

Audit and feedback has the potential to changepractice (12 studies)

reminders based on audit positive

frequent feedback reinforcement positive (>> infrequent)

written versus discussion feedback (no trials)

Educational outreach visits (18 studies) promising but cost-effectiveness not measured

Use of local key opinion leaders (KOLS) (8 studies)

6/7 trials measured (at least) one improvement in outcome (2 s.d.)

three trials on patient outcomes: one achieved significant impact

BUT how are KOLS identified?

OBrien et al2001 a,b,c


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Targeting doctors in US HMOs:can we influence prescribing / carepatterns? Written recommendations

Breast screening (NC, USA): 83% GPs aware only 8% complied

Cholesterol reduction: only 6.6% of those eligible received drug

BUT with CME:

Attendees (any session) more likely to change practice CVS risk : 40% of attendees prepared to change

Care of homebound elderly: 63% attendees made home visits (47% NA)

Impact of peer and patient feedback - MINOR to MODERATE :

83% considered change in therapy

66% initiated change

Impact of pharmaceutical detailing MAJOR effect

Sbarbaro, CID 2001; 33 (s3):S240-4


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Patients, doctors, regulatorsand industry

CONFLICTS BETWEEN PRIMARY CARE DOCTORS ANDOTHERS

Patient demands

Time demands of familiarization with formularies and guidelines

OTC delivery by pharmacies (nurse prescribing in UK) Advice from Pharmaceutical representatives

Persuasion / inducements

REGULATORY AUTHORITIES

desire appropriate prescribing BUT

don't pay to support education and working practices

INDUSTRY: MARKETING BUDGET 35% R&D + PROFITS33%

DOCTORS GET ++ DRUG INFORMATION FROM INDUSTRY

Holmes; Monnet & Sorenson, CMI 2001; 7 (s6);Huchon et al. Eur Respir J 1996; 9:15901595


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Resistance is a (marketing)opportunity!

To alter prescribing (Consensus perspective):

Restriction to appropriate use

Preserving current drugs for the future

To alter prescribing habits (industry perspective):

Our drug rather than their drug

Our drug (which is more appropriate) than their drug

Most effective drug:

Maximum PD effect: choice, dose, duration

Partnership in initiatives:

Non-promotional: GlaxoSmithKline, Bayer (guidelines)

Others


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The Iowa experience 19982000:implementing a strategy tocounter resistanceDept Public Health Task

Force:

Statewide surveillance

Guidelines on

appropriate use Repeated press

conferences

Media coverage - TV -Internet

HMOs target topprescribers:

Notification letters

Guidelines

Prescribing algorhythms

Overall effects onprescribing

use of first-lineagents

inappropriateprescribing

costs

?? effects onresistance ??

Bell, Amer J Managed Care 2002, 8:988-94


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The Iowa experience 19982000:effects on three healthcaresystems prescribers Medicaid:

81% reduced their prescribing

21% fewer insurance claims

20% fewer patients treated

John Deere:

16% first-line prescribing 10% fewer insurance claims

Wellmark: 23% penicillin prescriptions 23% macrolide prescriptions

Bell, Amer J Managed Care 2002, 8:988-94

Effects on resistanceprevalence

not measured


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European Union, NorthAmerica and

WHO initiativesGuidance includes: control of resistance in the community

surveillance of resistance and antibiotic usage

encouragement of judicious use

in addition, guidance advises: prevention, including vaccination (Pn, influenza), infectioncontrol

rapid diagnosis (near patient testing)

audit and (regular) feedback

Details: 18 national initiatives: UK, US, Canada, France,

Belgium, Aus, Fin, Swe

5 international: WHO, EU, Copenhagen, Toronto,Washington

But implementation is lackingCarbon et al, CMI 2002;8 Suppl 2):92-106


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Moving from recommendation toimplementation:repeated education and feedbackinitiativesINTERVENTIONS:reduce inappropriate use, disease burden & bacterialcolonizationANTIBIOTIC USE:

Education using relevant data, interactive teaching with feedback,AUDIT

Link use and resistance (and outcomes) VIA SURVEILLANCE

IMPROVE DIAGNOSIS and severity assessment

Assess OUTCOMES: mortality, morbidity, complication rates, QoL,hospitalizations

Assess COST savings

Implement (consistent) guidelines (principles) and treatmentalgorithms

Delayed treatment or non-antibiotic therapy

TARGET (AND CONTROL) HIGH PRESCRIBERS

EDUCATE CONSUMERS Carbon et al, CMI 2002;8 Suppl 2):109-128


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Initiatives in lower-incomecountries:

recognized problems Inadequate healthcare infrastructure andcohesion NB public services, country clinics and private services

Lack of resources (money, people, diagnostics,surveillance)

Difficulties with training and education

Poor regulatory controls

Geographical / political logistics

Population dynamics and beliefs

Unrecognized problems


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Initiatives in low-incomecountries:37 available studies by region andtarget groupTarget Groups:

Region Community

PrescribersDispensers

Multi-target

Total

Asia 4 8 3 6 21 (57%)

Africa 2 4 2 1 9 (24%)

Latina 3 1 1 1 6 (16%)

MENA - - 1 - 1 (3%)

NewlyIndep

- - - - NONE

Totals 9 (24%) 13 (35%) 7 (19%) 8 (22%) 37(100%)

Radyowijati and Haak 2003, Soc Sci Med ; 57: 733-44


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Peter BallUniversity of St Andrews,

Scotland

Practical Issues:

Implementing

principles II


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Implementation process:continued education, audit

and feedbackIdentifyprescribers:

Specific targets:

high prescribers,incentives

Educate:

Resistance /outcomes Use of

principles in RTIAssisteddiagnosis

Implement:

Achievableobjectives in

appropriate groups

- with incentives (if

Audit:

Confidential orpublic.

reinforcement,

support (HS and

TARGETSPatients: age, diseaseSite: 1o care, clinic, hospital,pharmacy (OTC), unqualified

personel, othersCHOICES


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Implementation process:integrating messages and

targetsPrescribers:Doctors,

pharmacists,nurses, clinics,

quacks andothers

Serviceproviders($$):

NHS, HMOs, AIDorganisations

(WHO, RedCross), military,

Patients:

Individualeducation,consumer

groups, diseasefocus and

Supportorganisations:

Media (press,radio, TV),

clerics, teachers.Posters,

Currentinitiativ

es?


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Changes in prescribing USA:1989-2000

Good news and bad news Office prescribing(children) Decade 1989-2000:

47% reduction

McCaig JAMA 2002,

287:3096 Out-patients (children)

Decade 1989-2000:50% reduction

Steinmann et al Ann Int Med

2003; 183:525-33 BUT a 23% 40% increase

in broad spectrumprescriptions

Cost of proprietary BS was10-fold higher than genericsin 1997

2

8

14

4

-25-20

-15

-10

-5

0

5

10

15

20

Colds/ARI

Pharyn

gitis

Ac

bronch

itis

Otitis

media

OverallBS antibiotics


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Are administrative (imposed)restrictions beneficial?An example Restrictive formulary policy imposed on six

US HMOs

Limitations on drugs within a class or classes

Exclusion of certain classes completely

Overall care costs increased

The most restrictve policies = greatest cost increase

Policies driven by cost (acquisition of drug)

ignore overall benefits,

have unexpected consequences

Han et al. Amer J Managed Care 1996; 2:253


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Unexpected outcomes inAustralia:

initiative to reduce co-moxiclav usage in primarycare

The policy created:

unintended changes in prescribing behaviour

higher costs (significant increased hospitalization/investigation)

a trend towards poorer individual patient outcomes

Number

ofpatients

Beilby et al. Clin Infect Dis 2002

0

100200

300

400

500

600

Hospita

lizatio

n

Referrals

Radiolog

y

Patholog

y

O

ther

tests

Before letter

After letter


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Potential

Diagnosis Message reduction (%)

Otitis media No antibiotic for OME 30

Pharyngitis No antibiotic unless Strep+ 50

Bronchitis No antibiotic unless specific 80

infection or lung disease

Sinusitis No antibiotic unless prolonged/ severe 50

Common cold No antibiotic 100

To reduce misuse/abuse bydoctors:

Message: do not useantibiotics for .

CENTERS FOR DISEASE CONTROLAND PREVENTION

Similar campaign highly effective in HK: Seto, 2003


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Patients also need messages

Antibiotics are under threat current ones are less effective than before

new ones are running out

MANY INFECTIONS DO NOT NEED ANTIBIOTICS:COLDS, FLU,SORE THROATS ETC.

In this situation: antibiotics do no good, and may cause side effects,

friendly bacteria to become resistant

Your GP should advise you when antibiotics are needed

He should use antibiotics which

kill bacteria rapidly and make you better sooner

are cost-effective

cause less side effects

are least likely to cause resistance

Please do not hoard antibiotics for the next time


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Impact of a public campaignfor more rational use of

antibiotics in Belgium,Nov 2000 to March 2001

Beauraind et al, personal communication; http://www.antibiotiques.org

Expect antibiotic for flu:

49% (before) vs. 30% (after)

Expect antibiotic for sore

throat:32% (before) vs. 18% (after)

Less antibiotic to avoidresistance:

64% (before) vs. 75% (after)Antibiotics must beprotected:

13% (before) vs. 25% (after)

Total antibiotic salesdecreased b


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Reduced prescribing in AOM:observation, pain relief, safety-net (delayed)antibiotic prescription Excluding severe illness: Rx pain relief and safety-net antibiotic prescription to

be filled only if symptoms persist

20% reduction in antibiotic usage (UK)1

only 55/178 (31%) parents filled prescription (OHIO /KENTUCKY USA)2

Reducing demand in acute bronchitis

Explanatory pamphlet: reduced prescription uptake by 15% (p=0.04)3

Education of both patient AND doctor: reduced Rx 74% 48% (p=0.003)4 BUT 93% of US parents think antibiotics essential for childhood bronchitis5

1. Cates Brit Med J 1999; 318:715-6,

2. Siegel et al, Pediatrics 2003; 112:527-531 ;

3. Macfarlane et al. BMJ 2002; 324:16;

4. Gonzales et al. JAMA 1999; 281:15121519;

5.Belongia et alPrevent Med 2002, 34:346-352


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In lower income countries:patient factors in Pakistan

50% of the population live below the poverty line

half the population is illiterate

access to doctors is limited

Prescriptions from Quacks and Hikmat

Compliance problems are common and include: lapse in dosing, stopping Rx early, hoarding

Over-the-counter (OTC) sales are available:

excessive costs and unnecessary side effects

driving antibiotic resistance

sub-optimal dosage and inadequate duration

Zafar Ullah Khan 2003


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Initiatives in low-incomecountries:37 available studies by region andtarget groupTarget Groups:

Region Community

PrescribersDispensers

Multi-target

Total

Asia 4 8 3 6 21 (57%)

Africa 2 4 2 1 9 (24%)

Latina 3 1 1 1 6 (16%)

MENA - - 1 - 1 (3%)

NewlyIndep

- - - - NONE

Totals 9 (24%) 13 (35%) 7 (19%) 8 (22%) 37(100%)



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Determinants of antibioticprescribing in

low-income countries (overviewof 37 studies)


Number of studies reporting

Many clearopportunities

forintervention0 16

Lack of knowledge

Poor or delayed lab results

Inadequate drug supply

Economic incentives

Doctors fear of failure

Folk beliefs/traditions

Patient/customer demand

Marketing influences

Untrained advice / self medication

Prescribers Dispensers Public

d i i i f i


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Suggested priorities for action

in low-income countries Government: regulate prescribers (NB private sector)

INITIATE AND SUPPORT surveillance of use and resistance

PROMOTE preventative medicine and education of dispensers

Health Service and Health Care Organisations: ASSESS appropriate use,

PROVIDE principles and guidelines, AUDIT compliance

Training institutions: SCHEDULE curriculum time and TEACHappropriate use

Professional Societies: PROVIDE evidence-based CME

Pharmaceutical Industry:

CONTROL promotion, INFORM prescribers/consumers as to prudent use

Consumer Associations: MAKE APPROPRIATE USE ACONSUMER ISSUE

Radyowijati and Haak 2003, Soc Sci Med ; 57:-

K


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Kenya:Some key issues driving antibioticresistanceNational issues:

no (or inadequate) resistance surveillance

no antibiotic policies (or no compliance) in most large hospitals

inadequate infection control protocols

insufficient qualified personnel for supervision of laboratories

Clinical / laborarory issues:

antibiotic choices: empirical or based on poor quality specimens /lab reports

> 40% of clinicians only send specimens after failure of initialtherapy

misinterpretation of serology, e.g. Widal reactions (falseepidemics)

massive abuse of ciprofloxacin and increase in FQ resistance

misuse of BSPs: for example, 3rd gen Cefs for ARI

massive burden of HIV-AIDS population

Revathi, 2003

K


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Kenya:Prevalence of HIV in

hospitalized children

0

500

1000

1500

2000

2500

1997 1998 1999 2000 2001 2002Year

Numberofc

hildre

n

HIV uninfectedHIV infected

Diff b t l


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Differences between rural areasand towns:Prescriptions and PRSP inVietnamese childrenPharmacies prescribing antibiotics for ALL RTI: ~ 99%

Healthcare preferences Urban % Rural %

Pharmacy (cost factordominant)

37 95

adequate dose and duration 50 27

Family member 11 80

Private doctor 77 47

Traditional doctor 7 8

Penicillin I/R pneumococi NP 83% 38%

Quagliarello et alJ Hlth Popul Nutr 2003; 21:316-24

I d ibi i Vi t


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Improved prescribing in VietNam

(Hai Phong) Commune health station study: given US$ grant for drugs (andimplementation of education)

Outcome measures: % receiving ABand % receiving adequate dosageafter retraining and incentives

NB continued evaluation andsupervision

Chalker, WHO Bulletin 2001;79:313-320

Observation period(months)0

25

50

75

100

0 1 6 12 15 18

AB prescribedAppropriate dose

(S ) b i t


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(Some) barriers toimplementation

of Principles Lack of Interest in resistance and relevance of existing guidelines Inadequate funding

Health-care systems

staffing of health care (clinical AND laboratory)

Restriction of availability and reimbursement issues (costs to

underprivileged)

OTC or other non-medical prescribing

Formulary (DTC) and guideline committees

Pharmacists fear threats to autonomy / integrity

Excessive pressures from Industry

Patient (or parent)

Expectations

self diagnosis and beliefs about antibiotics

Cultural and religious issues

Are thesefactors

problems orare they the

keys topotential

answers?

Pl id


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Please consider:are barriers actually

opportunities? Implementation: a message with a benefit reduced failures ~ resistance Patients / System

reduced consultations / return visits Primary Care / System

reduced acquisition / retreatment costs Pharmacy budget / patients

reduced hospitalisation costs Government / HMO / Patients

reduced litigation potential Doctors Proven outcome benefit

more time, patients, income (leisure) Doctors

less time off work Patients / Society

Reduced bacterial resistance Future generations

THERE IS NO DOWNSIDE OR DISADVANTAGE TOWIDESPREAD IMPLEMENTATION

Pl id


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Please consider:Where should implementation

commence? Areas of high resistanceprevalence? Best chance of showing a

difference, or,

best chance of failure?

Countries with highestantibiotic consumption?

Countries with activesociety structure?

Countries with existing

initiatives? Do they work

Countries withauthoritarian infra-structure

Which patients, diseasegroups?

How can the Core ConsensusGroup assist with:

Regional / local consensus?

Societies and Prescriber / PatientGroupings?

Credibility: to whom will PCPslisten?

What will change their practice?

Implementation, audit, feedback?

Where will the funding comefrom?

ball implementation inspiration feb 2006[1]

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