La stewardship antimicrobica tra esigenze cliniche e spending review - Milano, 13 settembre 2013 I congressonazionale SIFACT
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Milano, 13 settembre 2013
I °congresso nazionale SIFACT
La stewardship antimicrobica
tra esigenze cliniche e spending review
Pierluigi Viale Clinica di Malattie Infettive Policlinico S. Orsola – Malpighi
The development of antimicrobial agents represents one of the most significant achievements in medicine during the past century. However, the emergence of antimicrobial resistance combined with the downturn in the development of new antimicrobial agents in the pharmaceutical industry poses unanticipated challenges in the effective management of infection. The question arises, how can we most effectively utilize this invaluable resource, antimicrobials, in the face of ever more difficult to treat infections? This question serves as the fundamental basis for the concept of antimicrobial stewardship.
The best definition of ANTIMICROBIAL STEWARDSHIP A marriage of infection control (Epidemiologist) and antimicrobial management (Infectious Diseases specialist) finalized to share the principles of the optimized treatment between the bench to bed side point of view and the hospital-wide vision
SPENDING REVIEW IN TERAPIA ANTIMICROBICA
Ipotesi di lavoro
1. Rinunciare a gestire o semplificare la gestione delle problematiche
infettivologiche dei pazienti con co-morbosità maggiore
Epidemiology, Antibiotic Therapy, and Clinical Outcomes in Health Care–Associated
Pneumonia: A UK Cohort Study Chalmers JD et al, Clin Infect Dis 2011;53:107
OUTCOME
In the HCAP cohort, 92.8% of patients received treatment consistent with CAP guidelines,
with only 7.2% receiving agents recommended for HAP and active against P. aeruginosa and/or
MRSA.
In univariate analysis, HCAP was associated with an increased 30-day mortality of 14.8%,
compared with 7.5% in CAP patients (P = .002). HCAP, however, was not associated with an
increased rate of mechanical ventilation or vasopressor support (HCAP: 5.8%; CAP: 7.9%; P 5
.3).
The univariate odds ratio (OR) for HCAP and 30-day mortality was 2.15 (1.44–3.22; P =
.002), but this reduced to a nonsignificant association (OR 1.29 [0.83–2.01]; P= .3) after
adjustment for baseline PSI, comorbidities, and antibiotic therapy. In the fully adjusted
model, taking account of risk factors for aspiration and premorbid functional status, this
trend disappeared entirely (OR 0.97 [0.61–1.55]; P = .9).
59.9% of patients with HCAP had treatment restrictions compared with 29.8% of patients
with CAP (P < .0001). Repeating the multivariate analysis in patients without treatment
restrictions, HCAP was not associated with 30-day mortality (AOR 0.57 [0.20–1.64]; P = .3)
or requirement for MV/VS (AOR 0.72 [0.30–1.70]; P = .4).
SPENDING REVIEW IN TERAPIA ANTIMICROBICA
Ipotesi di lavoro
1. Rinunciare a gestire o semplificare la gestione delle problematiche
infettivologiche dei pazienti con co-morbosità maggiore
2. Puntare sui farmaci biosimilari
3. Ridurre il ricorso a terapie di combinazione ridondanti
4. Graduare l’aggressività terapeutica sulle condizioni del paziente
5. Evitare indagini microbiologiche superflue
6. Usare correttamente i biomarker
7. Shift precoce da terapia EV a terapia PO
8. Ridurre i tempi di terapia
9. Ridurre i livelli di inappropriatezza prescrittiva in ospedale e sul territorio
STEWARDSHIP ANTIMICROBICA
A marriage of infection control (Epidemiologist) and antimicrobial
management (Infectious Diseases specialist) finalized to share the
principles of the optimized treatment between the bench to bed side
point of view and the hospital-wide vision
RUN FOR THE APPROPRIATENESS
of the prescriptions not only for the costs saving
Checking the quality instead of the quantity
The concept of APPROPRIATENESS - RIGHT INDICATION (epidemiologically, microbiologically and PK/PD driven) - RIGHT DAILY DOSE - RIGHT MODALITY OF ADMINISTRATION - RIGHT PRESCRIBER - SHARED CRITERIA FOR DE-ESCALATION / SWITCH / INTERRUPTION
La Gestione del rischio infettivo in Emilia-Romagna
il nuovo assetto organizzativo
DELIBERAZIONE DELLA GIUNTA REGIONALE 25 MARZO 2013, N. 318
Linee di indirizzo alle Aziende per la gestione del rischio infettivo: infezioni correlate
all’assistenza e uso responsabile di antibiotici
Comitato Infezioni Ospedaliere
Nucleo Strategico
Nucleo Operativo
Nucleo Operativo
per l’uso
per il controllo
responsabile di
delle ICA
antibiotici
Antimicrobial stewardship programs- The devil is in the details
Cunha CB et al, Virulence 2013; 4:2, 147–149
Antimicrobial stewardship is a developing field, and every program must
be tailored to its respective institution and each article has a distinctive
focus and perspective.How to lay out a stewardship program ? -Hospital wide -Drug directed -Setting directed -Disease directed
Global impact of an educational antimicrobial stewardship programme on prescribing
practice in a tertiary hospital centre. Cisneros JM et al, Clin Microbiol Infect 2013 Feb 27
Setting
Hospital Universitario Virgen del Rocıo, in Seville (Spain), a 1251-bed
tertiary care teaching medical centre including 90 ICU beds and an active
solid-organ and hematopoietic stem-cell transplantation programme. Until
this program was designed, only preauthorization formulary-restriction for
imipenem, meropenem, ertapenem, colistin, sulbactam, tigecycline,
vancomycin, teicoplanin, linezolid, daptomycin, voriconazole, caspofungin,
mycafungin, anidulafungin and liposomal amphotericin existed and were
accessible 24 h a day, including weekends, with disappointing results.Global impact of an educational antimicrobial stewardship programme on prescribing practice in a tertiary hospital centre. Cisneros JM et al, Clin Microbiol Infect 2013 Feb 27 Institutional Programme for the Optimization of Antimicrobial Treatment (PRIOAM) 1. Institutional agreements 2. Constitution of a multidisciplinary operations It was coordinated by an infectious diseases (ID) specialist and included a pharmacist, an intensive care and preventive medicine specialist, a paediatrician and a microbiologist, as well as an expert in clinical documentation. 3. Elaboration of local guidelines Sixty-four physicians from different clinical departments, coordinated by the ID specialists, were asked to elaborate clinical guidelines for the use of antimicrobials 4. PRIOAM implementation —The aim of the programme and the clinical guidelines were presented and discussed during clinical sessions in each clinical department of the hospital. Guidelines were sent via e-mail to all physicians andremained available on the intranet webpage of the hospital. PRIOAM was included in the training programme for medical residents.
Global impact of an educational antimicrobial stewardship programme on prescribing
practice in a tertiary hospital centre. Cisneros JM et al, Clin Microbiol Infect 2013 Feb 27
Methodology of active intervention
The main activity of the programme consists of a training programme directed
towards all antibiotic prescribers in the centre based on counselling interviews,
carried out by a group of clinical experts who were selected by the PRIOAM
operations team, and included 7 ID specialists, 6 critical-care specialists and 4
paediatricians.
PRIOAM advisors were selected from local leaders in the management of patients
with infectious diseases in each area. Each advisor conducted counselling
interviews in his/her area of responsibility.
The number of counselling interviews scheduled for each clinical department was
proportional to its antimicrobial consumption: < 50 DDDs -> one per week,
50 to 100 DDD -> two per week
> 100 DDD -> 3 per week.Global impact of an educational antimicrobial stewardship programme on prescribing practice in a tertiary hospital centre. Cisneros JM et al, Clin Microbiol Infect 2013 Feb 27 The advisor reviewed the antimicrobial treatment with the prescriber, examined the patient’s clinical data and discussed the main aspects of the prescribed treatment and diagnosis of the infectious syndrome using a specific questionnaire. Prescriptions were considered as ‘appropriate’ when all items of the questionnaire had been accomplished correctly. If one or more of them were incorrectly performed, the prescription was evaluated as ‘inappropriate’. To guarantee homogeneity, the PRIOAM team also coordinated monthly training meetings with these advisors, which also served to monitor the progress of the programme.
Global impact of an educational antimicrobial stewardship programme on prescribing practice in a tertiary hospital centre. Cisneros JM et al, Clin Microbiol Infect 2013 Feb 27 A total of 1206 CIs were performed during the first year of the programme. Interviews lasted approximately, 10 min, the equivalent of 201 working hours for the 1206 CIs. The most frequently performed assessments were for empirical prescriptions (52.2%, n = 630), followed by targeted treatments (25.4%, n = 306) and surgical prophylaxis (22.4%, n = 270).
Global impact of an educational antimicrobial stewardship programme on prescribing practice in a tertiary hospital centre. Cisneros JM et al, Clin Microbiol Infect 2013 Feb 27 rates of inappropriate antimicrobial use
Global impact of an educational antimicrobial stewardship programme on prescribing practice in a tertiary hospital centre. Cisneros JM et al, Clin Microbiol Infect 2013 Feb 27 Evolution of the consumption by class of antibiotics
How to lay out a stewardship program ? -Hospital wide -Drug directed -Setting directed -Disease directed
The International CAP Collaboration Cohort study: Rationale, design and description
of study cohorts and patients Myint PK et al, BMJ Open 2012;2:e001030.
• Six cohorts assembled from 1991 to 2007 including 13,784 patients
(median age 71 years, 54% men)
• A total of 6159 (44%) had severe pneumonia by PSI class IV/V
• Overall Mortality at 30 days was 8% (1036)
• Admission to intensive care was 8% (1059)Most common reasons for antimicrobial treatment failure in severe CAP Delayed initiation of antibiotics Empirical therapy not including two drugs, preferably with anti-pneumococcal actvity Inadequate empiric antimicrobials, discordant with guidelines Empirical antibiotics failing to cover for MDR S. pneumoniae, P. aeruginosa, MRSA
What Are the Potential Cost Savings Associated
with Decreased Length of Stay with CAP?
A cost savings for each day of reduction in length of
Stay between $2,273 and $2,373 in 2009 USD
Economic benefit of a 1- day reduction in hospital stay for CAP
Kozma CM, et al. J Med Econ. 2010;13:719–27Effect of a 3-Step Critical Pathway to Reduce Duration of Intravenous Antibiotic Therapy and Length of Stay in CAP. Carratalà J et al, Arch Intern Med. 2012;172:922-928. Prospective, randomized trial. Enrolled patients (401 adults who required hospitalization for CAP) were randomly assigned to follow a 3-step critical pathway including early mobilization and use of objective criteria for switching to oral antibiotic therapy and for deciding on hospital discharge or usual care. Primary End Point: LOS. The 3-steps of the critical pathway were (1) early mobilization of patients; (2) use of objective criteria for switching to oral antibiotic therapy; and (3) use of predefined criteria for deciding on hospital discharge. Early mobilization was defined as movement out of bed with a change from the horizontal to the upright position for at least 20 minutes during the first 24 hours of hospitalization, with progressive movement each subsequent day during hospitalization, as described elsewhere. Criteria for switching were ability to maintain oral intake; stable vital signs (considered as temperature 37.8°C, respiratory rate 90 mm Hg without vasopressor support for at least 8 hours); and absence of exacerbated major comorbidities (ie, heart failure, COPD) and/or septic metastases. Predefined criteria for hospital discharge were meeting criteria for switching to oral antibiotic, baseline mental status, and adequate oxygenation on room air (PaO2 60 mm Hg or pulse oximetry >90%).
Effect of a 3-Step Critical Pathway to Reduce Duration of Intravenous Antibiotic Therapy and Length of Stay in CAP. Carratalà J et al, Arch Intern Med. 2012;172:922-928.
Effect of a 3-Step Critical Pathway to Reduce Duration of Intravenous Antibiotic Therapy and Length of Stay in CAP. Carratalà J et al, Arch Intern Med. 2012;172:922-928.
STUDIO DURATION
INDIVIDUALIZZAZIONE DELLA DURATA DELLA TERAPIA ANTIBIOTICA IN
PAZIENTI OSPEDALIZZATI CON POLMONITE ACQUISITA IN COMUNITA’:
STUDIO RANDOMIZZATO CONTROLLATO, DI NON INFERIORITA’Al raggiungimento della stabilità clinica …
ossia quando presenti TUTTI i parametri sotto riportati
Sfebbramento da almeno 24 ore senza antipiretici
Miglioramento dei sintomi (tosse, dispnea, espettorazione)
Stabilità emodinamica (PA sist >= 90 mmHg)
Assenza di incremento degli indici di flogosi
ARRUOLAMENTO E RANDOMIZZAZIONE
Gruppo A
Durata “standard “ della terapia antibiotica a discrezione del medico di reparto
Gruppo B
Terapia antibiotica per 48 ore dopo raggiungimento della stabilità clinica poi stop
PRIMO CONTROLLO STABILITA’ CLINICA: + 72hHow to lay out a stewardship program ? -Hospital wide -Drug directed -Setting directed -Disease directed
Procalcitonin for reduced antibiotic exposure in the critical care setting: A systematic
review and an economic evaluation Heyland DK et al, Crit Care Med 2011; 39
Effect of procalcitonin-guided therapy on duration of antibiotic utilizationProcalcitonin for reduced antibiotic exposure in the critical care setting: A systematic review and an economic evaluation Heyland DK et al, Crit Care Med 2011; 39 Effect of procalcitonin-guided therapy on hospital mortality
Procalcitonin for reduced antibiotic exposure in the critical care setting: A systematic review and an economic evaluation Heyland DK et al, Crit Care Med 2011; 39 Base case cost-minimization analyses
Se nell’area vasta Emilia Centro (provincie di Bologna e Ferrara)
si usassero di routine ACE-inibitori anziché Sartani nella prima
linea terapeutica dell’ipertensione arteriosa, e se tutte le
proscrizioni di ACE-inbitori brand passassero ai generici, il
risparmio annuo sarebbe di circa ….
11.500.000 Eur
Spese per antifungini e antibiotici 2012 nell’AOU Policlinico S. Orsola-Malpighi
antifungini: 1.930.000
antibiotici: 2.274.000You can also read
