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Antimicrobial Stewardship: Media and Literature Update
1. Antimicrobial Stewardship
(PROA): Media and
Literature Update
José Ramón Paño
Servicio de Enfermedades Infecciosas
Hospital Clínico Universitario
4 de octubre de 2016
3. Outline
• Antimicrobial stewardship in the political agenda
• New antimicrobials: how to promote its
development
• Overall assessment of the impact of AMS programs
• “Shorter is better” (Apropos of CAP)
• Reported b-lactam allergy: more room for
improvement than expected?
• AS from the Microbiology Lab
4. 1. ECDC Draft Technical Report: July 2016
2. Open to public consultation: (Sept, 5th)
3. Draft Guideline: (Oct, 21st)
6. Proposal for EU draft guidelines:
technical report or wish list?
7. Proposal for EU draft guidelines:
technical report or wish list?
• Ensure timely access to clinical microbiology laboratory services.
For acute care hospitals, these services should be provided on a
24/7 basis for critical specimens [expert consensus]
• Salary support and dedicated time for antimicrobial
stewardship activities. Example: 0.5–1.5 full-time equivalents
(FTEs) per 250 acute care beds [15,16]. Example of indicator:
number of FTEs for antimicrobial stewardship activities.
3. Healthcare facilities (resources, systems
and processes for healthcare facilities)
8.
9.
10. Nosotros, Jefes de Estado y de Gobierno y representantes de los
Estados y Gobiernos, reunidos en la Sede de las Naciones Unidas en
Nueva York el 21 de septiembre de 2016 (…)
(…) Por consiguiente, nos comprometemos a trabajar en los planos
nacional, regional y mundial para: (…)
(…) b) Movilizar financiación suficiente, previsible y sostenida,
recursos humanos y financieros e inversiones por conducto de
canales nacionales, bilaterales y multilaterales para apoyar la
elaboración y ejecución de planes de acción nacionales, la
investigación y el desarrollo sobre antimicrobianos nuevos (…)
11.
12. New antimicrobials: how to promote
its development
“The findings support a form of a de-linkage model
and a combination of push and pull incentive
mechanisms”
Clinical Infectious Diseases. 2016 Aug 30
13. New antimicrobials: how to promote
its development
Sales-revenue de-linkage model
Clinical Infectious Diseases. 2016 Aug 30
• De-linkage model: Companies not paid on sales
volumes, but by established revenues (flat rates)
• Companies strive for high sale volumes to improve their
ROI, which can increase overuse of antimicrobials and can
contribute to resistance emergence.
- Allow R&D investments for a successful product w/o requiring high
product sales and could be adapted to simultaneously address
conservation
14. New antimicrobials: how to promote
its development
Clinical Infectious Diseases. 2016 Aug 30
Push incentives subsidize the overall development cost
Pull incentives reward successful development,
providing guaranteed return on investment (ROI)
• Tax credits
• Direct funding of research
• Public–private partnerships
• milestone or prize payments
• patent buyouts
• advanced market commitments
• and value-based or high reimbursement
• regulatory incentives
15. Objective: To describe implementation of AS
activities in 47 Southafrican private hospitals
Setting:
• Private hospitals operated by NetCare (7/9 SA regions)
• 64 pharmacists (employees) y 4290 médicos (self-employees)
• 9424 beds (ICU: 1601)
• ID scareceness
16. Intervention (2009-2014):
- 3 phases: pre, implementation y post-implementation
Phase I Preimplementation: 16 months
- Result indicators:
- Process indicators
1. Omission of blood cultures before starting antimicrobials
2. > 7 days duration in the absence of indication (local guideline)
3. > 7 days duration in the absence of indication (local guideline)
4. Simultaneous use of ≥ 4 antimicrobials
5. Redundant coverage
- Approach: Quality improvement (IHI)
I.1. Define goals and indicators
1. Global antimicrobial consumption
2. Implementation
Brink A. Lancet Infect Dis. 2016;16(9):1017–25.
17. Brink A. Lancet Infect Dis. 2016;16(9):1017–25.
Fase I Preimplementation (16m)
I.2. AS model design
• Non-restrictive (preserving prescribers’ autonomy) -> audit &
feedback: detection-review-feedback1-registry-feedback2
• Backbone = PharmD -> Voluntary involvement (no monetary
involvement)…but dedicated time
I.3. “Champions” (PharmD) recruitment
I.4. Assessment of baseline situation (survey)
• Set-up of an AS multidisciplinary committee
• Implementation (speed) adapted to institution circumstances
18. Brink A. Lancet Infect Dis. 2016;16(9):1017–25.
Fase II Implementation
(24 m)
Fase III PostImplementation
(20m)
• Fase II: 31 learning cycles
• Fase III: AS as “standard of care” (22 cycles)
23. Conclusions
• Non-restrictive AS approach based on prescribers’
involvement with PharmD as program leader ->
significant impact in antimicrobial consumption (SA)
• How much of the results are due to audit & feed-back?
(reduced number of time-consuming interventions)
• Patient outcomes? Antimicrobial resistance?
Brink A. Lancet Infect Dis. 2016;16(9):1017–25.
24.
25. • Población: Adultos ingresados con NAC* en 4
hospitales vascos
*NAC: nuevo infiltrado + 1 síntoma (fiebre / tos / disnea / dolor torácico)
• Período: Enero 2012 a agosto 2013
26. Uranga A. JAMA Intern Med. 2016 Jul 25.
Criterios de exclusión
• Inmunosupresión
• Riesgo de patógenos resistentes
Trasplante de órgano sólido
Prednisona > 10mg/día x 30 días u otros inmunosupresores
Esplenectomía
Neutropenia
Institucionalización
Ingreso en los últimos 15 días
Uso de antibióticos sistémicos en los últimos 30 días
• Existencia de criterios de duración prolongada
Infección por P. aeruginosa o S. aureus
Complicaciones locales o a distancia
27. Uranga A. JAMA Intern Med. 2016 Jul 25.
Diseño
• Screening: Días 0-5: comprobar criterios inc/excl
• Aleatorización: día 5
- Máxima Tª 48h: 37.8ºC
- ≤ 1 criterios de estabilidad clínica
TAS < 90mmHg
FC > 100/min,
FR > 24 /min
SatO2 < 90%, o PaO2 <60 mm Hg (aire ambiental)
- Intervención: suspensión AB* el día 5
- Control : duración AB* según criterio clínico
*AB : antibiótico elegido por el médico responsable
28. Uranga A. JAMA Intern Med. 2016 Jul 25.
Variables resultado
A) Variables principales:
• Buena evolución clínica (d10 y d30): Resolución o mejoría
de los síntomas de neumonía sin reintroducir antibiótico
• Síntomas NAC (d10 y d30): Cuestionario validado
B) Variables secundarias:
• Duración de tratamiento antibiótico (días): desde la primera
dosis hasta el día 30
• Tiempo hasta mejoría/vuelta a rutina/resolución Rx
• Mortalidad (30 d)
• Recurrencia NAC
33. Conclusiones/discusión
“Our study indicates that the IDSA/ATS recommendations for
shorter duration of antibiotic treatment based on clinical stability
criteria can be safely implemented in hospitalized patients with
CAP, leading to a significant reduction in treatment
duration.”
Fortalezas:
• Estudio pragmático (vida real) con buen diseño y variables
relevantes
Limitaciones:
• Extrapolación a determinadas poblaciones
1. b-lactámicos
2. Fine V
3. Atención a criterios de exclusión
34. • Reported allergy to b-lactam antibiotics is common and often
leads to unnecessary avoidance in patients who could tolerate
b-lactam therapy.
• Majority of reported prior reactions are misclassified as allergies
• Moreover, many individuals with true prior immunoglobulin (Ig)
E–mediated reactions have loss of hypersensitivity over time
• Hypothesis: receipt of alternative therapy when a b-lactam agent
is the preferred therapy leads to worse clinical outcomes
MacFadden DR. Clinical Infectious Diseases. 2016 Ahead of print
35. “Trainee-led* prospective cohort study to determine
the burden and clinical impact of reported beta-
lactam allergy on patients seen by an infectious
diseases consultation service at 3 academic hospitals”
MacFadden DR. Clinical Infectious Diseases. 2016 Ahead of print
*Infectious diseases residents developed and initiated the study as the initial phase of a
division-wide, trainee-led quality improvement initiative
Methods (ii)
Study population: All inpatients seen in consultation
by ID service (Apr 2014-Jan 2015) on days that the ID residents were
present** for the review of cases.
**both weekdays and weekends. Routinely absent for 1 half-day per week of scheduled
teaching), without other systematically excluded days.
36. MacFadden DR. Clinical Infectious Diseases. 2016 Ahead of print
Methods (ii)
Prospective assessment of b-lactam allergy:
• During consultation review rounds
• Characterization of previous allergic reaction in:
- High risk: IgE-mediated (urticaria, bronchospasm, angioedema, or anaphylaxis),
Stevens Johnson syndrome [SJS], toxic epidermal necrolysis [TEN], and DRESS
- Low risk: rash, serum sickness, others
Preferred and chosen antibiotic therapies
• Determined by the consultant ID service based on the initial
patient presentation and assessment
Review of patient outcomes
• After the initial assessment, using comprehensive EMR
• Quality control: 7 covariates; random 10% pts; k:0.94 + 2 ID doc
37. Results
Reported b-lactam allergy
95 (19%)
Rececived b-lactam
47 (65%)
Didn’t receive b-lactam
25 (35%)
History of severe reaction
48%
Patients included
507
b-lactam preferred agent
72 (76%)
History of severe reaction
15%
P = 0.004
38. MacFadden DR. Clinical Infectious Diseases. 2016 Ahead of print
Results (ii)
Characteristic
No
reported
allergy
Reported
allergy but b-
lactam non
preferred
Reported allergy and b-
lactam preferred
Received
preferred AB
Did not
receive
preferred AB
N (507) 412 23 45 27
Inmunocompromised 72 5 9 3
Reported allergy description
IgE mediated 7 7 11
Other severe 0 0 1
Rash 9 15 9
Unknown 7 25 4
39. Results (iii)
Characteristic
No
reported
allergy
Reported
allergy but b-
lactam non
preferred
Reported allergy and b-
lactam preferred
Received
preferred AB
Did not
receive
preferred AB
Antibiotic administered
Penicillin 45 0 7 0
Ceph 124 0 22 1
BL/BLI 101 0 8 1
Carbapenem 34 1 10 3
FQ 22 5 0 8
Clindamycin 1 1 0 5
Glycopeptide 50 12 0 5
Aminoglycoside 3 1 0 1
Other 32 3 0 1
40. Results (iii)
Characteristic
No
reported
allergy
Reported
allergy but b-
lactam non
preferred
Reported allergy and b-
lactam preferred
Received
preferred AB
Did not
receive
preferred AB
Site of infection
Bacteremia (primary) 59 4 14 4
Skin and soft tissue 54 3 7 5
Bone/Joint 53 5 5 2
Gastrointestinal 60 5 5 4
Genitourinary 52 2 5 5
Pulmonary 56 2 8 4
41. Results (iv)
Characteristic
No
reported
allergy
Reported allergy
but b-lactam
non preferred
Reported allergy and b-lactam
preferred
Received
preferred AB
Did not
receive
preferred AB
Primary outcome: Readmission + C. difficile + drug reaction + Acute kidney injury
67(16%) 5(22%) 11(21%) 10(40%)*
Secundary outcome
Readmission 24 (6%) 1(4%) 2 (4%) 6(24%)*
CDI 18 (4%) 1 (4%) 0 0
Drug reaction 2 (0.5%) 0 4 (9%)* 2 (8%)+
AKI 29 (7%) 3 (14%) 5 (11%) 4 (16%)
Mortality 55 (13%) 1 (4%) 10 (21%) 2 (8%)
Multivariate analysis
Primary outcome 3.18 (1.28–7.89)
Patient outcomes: univariate analysis
*p< 0.05
42. Conclusions
• “Reported b-lactam allergy was common and led to
a significant proportion of patients receiving
alternative antimicrobial therapy.”
• “Avoidance of preferred b-lactam therapy was
associated with increased adverse outcomes (mainly
readmission and adverse reactions that required
discontinuation of therapy).”
• The risk of antibiotic-related reactions that required
discontinuation of therapy was higher among
patients carrying a label of allergy, regardless of
whether or not they received beta-lactam
43. Conclusions (ii)
• There is a significant need to develop formal models
of care within infectious diseases practices in order to
objectively assess reported b-lactam allergies and
optimize b-lactam use among patients without IgE-
mediated allergy or other serious reactions.
• There is need to introduce self-audit skills and
practice improvement and resource stewardship
at the trainee level.
44. Limitations
• Selection bias (referral)
- Frequency of ABX allergy
- Complexity of patients (maximum benefit
of optimized therapy)
• Questions
- No aztreonam prescribed? How was it
considered (preferred/non-preferred?
45. Dietz J. Am J Infect Control. 2016
• “62% of the patients had urine culture completed without
specific symptoms of urinary tract infection”
• Starting in April 2006, the facility automatically started sending
urinalyses with + nitrite or leukocyturia (≥8 WBC) for culture.
• Laboratory policy was changed in September 2014 to remove
the reflex urine cultures and instead require providers to o
• The patient’s urine sample is held in the laboratory for 3 days to
allow for urine culture to be added. A message was also added to
the laboratory results for all urinalysis and urine cultures
46. Langford BJ. J Clin Microbiol. 2016 Aug 24;54(9):2343–7
Antimicrobial Stewardship in the Microbiology Lab: Impact of
Selective Susceptibility Reporting on Ciprofloxacin Utilization and
Gram-Negative Susceptibility in a Hospital Setting
• A selective reporting policy was implemented which
involved the suppression of ciprofloxacin susceptibility
to Enterobacteriaceae when there was lack of resistance
to the antibiotics on the Gram-negative panel
• 400-bed community teaching hospital in Toronto, Canada
• On-site microbiology laboratory, with staff available
during daytime and evening hours
• Problems with C. diff and FQ-resistant P. aeruginosa
Notas del editor
A propósito de un ensayo clínico de duración de tratamiento antibiótico en CAP revisa el origen del fundamento y orígenes de algunos “dogmas” sobre la duración del tratamiento antibiótico.
Prolongar duración para prevenir resistencia -> Por un lado hay más reinfecciones que recurrencias. Por otro lado, la resistencia no suele aparecer en el sitio de infección sino en la microbiota
Existe evidencia acerca de que duraciones más cortas son igual de eficaces (y por tanto más seguras)
Estrategias para individualizar duración…delegar en el paciente.
Underlying propen- sity for multiple drug allergies in some patients ?
Underlying propen- sity for multiple drug allergies in some patients ?