ball implementation inspiration feb 2006[1]
TRANSCRIPT
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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%)
Radyowijati and Haak 2003, Soc Sci Med ; 57: 733-44
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Determinants of antibioticprescribing in
low-income countries (overviewof 37 studies)
Radyowijati and Haak 2003, Soc Sci Med ; 57: 733-44
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?