Restricted Anti-infective Indications CLINICAL PRACTICE GUIDELINE

Restricted Anti-infective Indications HNEH CG 10_06
CLINICAL PRACTICE GUIDELINE
Restricted Anti-infective Indications
Document Registration Number HNEH CG 10_06
Sites where CPG applies
Acute Networks Hospitals
Primary & Community Networks
Target Clinical Audience
Clinicians who prescribe restricted anti-infectives
Pharmacists
Applicability
Neonate – less than 29 days
*NB: *Please be aware that young
Children up to 16 years*
people between 16 and 18 years of
Adult (18 years and over)
age may have a number of other
All of the above
guideline, policy or legal
requirements that should be adhered
to but for the purposes of guideline
development can be considered adult
□
√
√
□
Summary
This document describes accepted indications for restricted
anti-infectives as defined by the HNE Health Area Antiinfective Working Party.
Keywords
Restricted antibiotics, antibiotic stewardship, patient safety
Replaces existing clinical
practice guideline or policy?
Yes
Registration Numbers of
Superseded Documents
HNEH CPG 08_04 from 6 March 2008
HNEH CPG 09_12 from 26 November 2009
Related documents (Policies, Australian Standards, Codes of Conduct, legislation etc)
•
Therapeutic Guidelines: Antibiotic, Therapeutic Guidelines, Melbourne, Victoria 2006
Clinical Network/stream leader
responsible for CPG
Dr John Ferguson, Area Director Infection Prevention and
Control
Contact Person/Position
Responsible
Dr John Ferguson, Area Director Infection Prevention and
Control
Contact Details
John.Ferguson@hnehealth.nsw.gov.au
Ph: 4921 4444
Issue Date:
14 September 2010
Review Due Date:
July 2013
Date authorised by Expert
Working Group/s
Area Quality Use of Medicines Committee - February 2009
Date noted by HNE Health
Clinical Quality and Patient
Safety Committee
9 September 2010
Trim Number
10/26-1-10
Version Two
Anti-infective Working Group - June 2010
September 2010
Restricted Anti-infective Indications HNEH CG 10_06
GLOSSARY
Listed of acronyms and terms with their definitions
Acronym or Term
Definition
MRSA
Methicillin-Resistant Staphylococcus aureus
VRE
Vancomycin-Resistant enterococci
C. difficile
Clostridium difficile, the important bacterial cause of post antibiotic
colitis/enteritis
IV
Intravenous
IM
Intramuscular
PO
Per-oral
Section 100 (S100)
Section 100 of the Highly Specialised Drugs (HSD) Program
Guidance DS registration
Provides for close analysis of restricted anti-infective prescriptions and use
with timely feedback to prescribers
mg/kg
Milligrams per kilogram in weight of child
CORB
Severity score for adults with community-acquired pneumonia. Confusion,
Oxygenation, Respiratory Rate and Blood Pressure
See HNE Health community-acquired pneumonia Clinical Practice Guideline.
2 g 8-hrly
2 grams every 8 hours
S. aureus
Staphylococcus aureus
JHH
John Hunter Hospital
MAC
Mycobacterium avium Complex
Haemophilus influenzae Type
b (Hib)
Bacterial infection associated with meningitis and epiglottitis
TG
Therapeutic Guidelines
CF
Cystic Fibrosis
AUC
Area Under the Curve
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Restricted Anti-infective Indications HNEH CG 10_06
GUIDELINE
Antimicrobial exposure is associated with the emergence and spread of antibiotic resistant organisms such as
Methicillin-Resistant Staphylococcus aureus (MRSA), Vancomycin-Resistant enterococci (VRE) and multi-resistant
Gram negative bacteria. Furthermore, Clostridium difficile infections may also be caused through antibiotic
treatment. The existence of hypervirulent epidemic strains of C. difficile internationally further increases the
importance of reducing antimicrobial use.
3 levels of anti-infective restriction exist:
1. Unrestricted anti-infectives (‘Category A’)
2. Restricted anti-infectives with approved indications (‘Category B’)
3. Anti-infectives requiring Infectious Diseases Approval (‘Category C’)
Summary of antibiotics: (Shaded agents require registration with Guidance DS)
Category A
Category B
Class
(see Appendix 1)
Amoxycillin
Amikacin
Antibiotics
Amoxycillin/clavulanate
Azithromycin (IV/PO)
Ampicillin
Aztreonam
Benzylpenicillin
Cefepime
Cefaclor
Ceftazidime
Cefuroxime
Cefotaxime
Cephalexin
Ceftriaxone
Cephazolin
Ciprofloxacin (IV/PO)
Clarithromycin
Clindamycin (PO)
Colistin (Inhaled)
Fusidic acid
Dicloxacillin (PO)
Lincomycin (IV)
Meropenem (for CF and
Doxycycline
bronchiectasis)
Erythromycin (IV/PO)
Flucloxacillin (IV/PO susp)
Norfloxacin
Gentamicin
Piperacillin/tazobactam
Griseofulvin
Rifabutin**
Metronidazole (IV/PO)
Rifampicin
Neomycin
Vancomycin (IV)
Nitrofurantoin
Vancomycin (PO)
Phenoxymethylpenicillin
Roxithromycin
Sulfamethoxazole/
Trimethoprim (IV/PO)
Tobramycin (IV/Inhaled)
Trimethoprim
Amphotericin lozenge
Antifungals
Fluconazole (IV/PO)
Itraconazole
Ketoconazole
Terbinafine
Tinidazole
Aciclovir (IV/PO)
Ganciclovir
Antivirals
Oseltamivir
Famciclovir
Ribavirin**
Valaciclovir
Antiprotozoals
Antimycobacterials
Category C
Colistin IV
Flucytosine
Meropenem*
Moxifloxacin (IV/PO)
Teicoplanin
Tigecycline
Linezolid
Amphotericin (IV)
Caspofungin
Posaconazole
Voriconazole (IV/PO)
Foscarnet
Cidofovir
Valganciclovir**
Artemether/lumefantrine
Artesunate
Primaquine
Dapsone
Ethambutol
Isoniazid
Pyrazinamide
Albendazole
Ivermectin
Praziquantel
Antihelminthics
* See page 3 and 4 for meropenem exemptions
** Unless Section 100 (S100) criteria met
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September 2010
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Restricted Anti-infective Indications HNEH CG 10_06
Appendix 1: Category B Drugs
Agents requiring Guidance DS registration at JHH are shaded in grey.
For other proposed indications at JHH discussion with Infectious Diseases Registrar (page: 5630) or on-call
Infectious Diseases Specialist is suggested (via 4921 3000).
Restricted Antibiotic
Amikacin (IV)
(See TG: Antibiotic for
dosing)
Azithromycin (IV/oral)
Adult: 500 mg daily
Child: 10 mg/kg up to 500 mg
daily
SWITCH TO ORAL AS
SOON AS PRACTICABLE
Aztreonam (IV)
Adult: 2 g IV 8-hrly,
Child > 2 yrs: 50 mg/kg up to
2 g IV 8-hrly
Cefepime (IV)
Adult: 2 g IV 8-hrly
Child: 50 mg/kg up to 2 g IV
8-hrly
Cefotaxime (IV)
Non-meningeal infections:
Adult: 1 g IV 8-hrly
Child: 25 mg/kg up to 1 g IV
8-hrly
Ceftazidime (IV)
Adult: 2 g IV 8-hrly
Child: 50 mg/kg up to 2 g IV
8-hrly
Ceftriaxone (IV)
Non-meningeal infections:
Adult: 1 g IV daily
Child: 25 mg/kg up to 1 g IV
daily
(Meningeal infections consult Infectious Diseases)
Accepted Indications and Comments
- Adult or paediatric respiratory patients – reserved for tobramycin-resistant
Pseudomonas
-
-
-
Cystic fibrosis acute exacerbation
Adult or paediatric respiratory patients – proven pseudomonal infection
(same dose usually together with once daily aminoglycoside)
-
Child with proven or suspected bacterial meningitis
(use 50 mg/kg up to 2 g IV 6-hrly)
Ongoing second line for child with severe pneumonia (if significant renal
failure or minor penicillin allergy present)
-
-
Ciprofloxacin (IV/oral)
Adult:
Oral: 500 mg 12-hrly
IV: 400 mg 12-hrly
SWITCH TO ORAL AS
SOON AS PRACTICABLE
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Severe community-acquired pneumonia (with CORB> 2)
Urethritis, cervicitis or conjunctivitis due to Chlamydia trachomatis
(Adult: 1 g oral as a single dose; child: 20 mg/kg up to 1 g oral as a single
dose)
Sexually acquired pelvic inflammatory disease (1 g single oral dose).
Should be used with ceftriaxone 500 mg IM/IV, oral doxycycline 100 mg
12-hrly and oral metronidazole 400 mg 12-hrly
Cystic fibrosis acute exacerbation
-
Cystic fibrosis respiratory exacerbation; especially infections due to
Burkholderia cepacia
Adult or paediatric respiratory patients – proven pseudomonal infection
(same dose usually together with once daily aminoglycoside)
Febrile neutropenia with a minor penicillin allergy
Proven or suspected bacterial meningitis (use 50 mg/kg up to 2 g IV 12-hrly)
Severe community acquired pneumonia (CORB≥2 and presence of
significant renal failure or minor penicillin allergy)
Spontaneous bacterial peritonitis
Pelvic inflammatory disease - sexually acquired (use with oral
metronidazole 400 mg 12-hrly, oral doxycycline 100 mg 12-hrly and oral
azithromycin 1 g as a single dose)
Disseminated gonococcal infection
Neisseria meningitides prophylaxis (second line)
All orbital (postseptal) or severe periorbital (preseptal) cellulitis (50 mg/kg
up to 2 g IV once daily)
Bites and clenched fist injuries with established infection (with
metronidazole)
Patients with bronchiectasis where ciprofloxacin sensitive Pseudomonas
aeurginosa is isolated
Salmonella enteritis
Pyelonephritis - proven gram negative organism resistant to narrower
spectrum agents, or patient unable to tolerate narrower spectrum
antibiotics due to allergy etc
Chronic prostatitis
Cellulitis after a water related injury
Diabetic foot infection
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Restricted Antibiotic
Clindamycin (oral)
Adult: 450 mg orally 8-hrly
Child: 10 mg/kg up to 450 mg
8-hrly
Fusidic acid (oral)
Adult: 500 mg 12-hrly
Ganciclovir (IV)
(see TG: Antibiotic for
dosing)
Lincomycin (IV)
Aerobic infection:
Adult: 600 mg IV 8-hrly
Child: 15 mg/kg up to 600 mg
IV 8-hrly
Anaerobic infection:
Adult: 900 mg IV 8-hrly
Child: 15 mg/kg up to 900 mg
IV 8-hrly
Meropenem (IV)
Cystic fibrosis:
Adult: 2 g IV 8-hrly
Child: 50 mg/kg up to 2 g IV
8-hrly
Restricted Anti-infective Indications HNEH CG 10_06
Accepted Indications and Comments
Intravenous clindamycin is no longer stocked by John Hunter Hospital. Please
see “lincomycin” as an alternative agent
Oral
- Infection due to a susceptible Gram positive organism in a patient with
major (type 1 or acute) allergy to beta-lactams
- For use combined with rifampicin for oral treatment of MRSA
-
-
Non-meningeal infections:
Adult: 1 g IV 8-hrly
Child: 25 mg/kg up to 1 g IV
8-hrly
Norfloxacin (oral)
Adult: 400 mg 12-hrly
-
Oseltamivir (oral)
Adult: 75 mg twice per day
for 5 days
Child: Dose varies according
to patient age and weight.
Please refer to oseltamivir
prescribing protocol on HNE
Health intranet
Piperacillin/Tazobactam
(IV)
Adult: 4/0.5 g IV 8-hrly
Child: 100/12.5 mg/kg up to
4/0.5 g IV 8-hrly
Higher doses may be
required – please contact
Infectious Diseases
-
-
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Treatment of cytomegalovirus infection in an immunocompromised patient
Prophylaxis for cytomegalovirus infection in a transplant recipient if oral
therapy not suitable
Infection due to a susceptible Gram positive organism in a patient with
major (type 1 or acute) beta-lactam allergy
Second line for severe sexually-acquired pelvic inflammatory disease in a
patient with major (type 1 or acute) beta-lactam allergy (with gentamicin).
Group B streptococcus prophylaxis in pregnant women with a penicillin
allergy
SWITCH TO ORAL CLINDAMYCIN AS SOON AS PRACTICABLE.
Cystic fibrosis acute exacerbation
Bronchiectasis where laboratory results demonstrate meropenem
sensitivity
All other uses must be first discussed with Infectious Diseases prior
to prescription and/or registration.
Directed treatment of multi-resistant Gram negative infection or empiric
therapy in septic hospitalised patient who has known or suspected multiresistant bacterial colonisation.
Directed treatment of urinary tract infection due to pseudomonas or other
multi-resistant Gram negative susceptible to norfloxacin
Prostatitis
Second line for primary and secondary prophylaxis of spontaneous
bacterial peritonitis in liver disease patients (400 mg daily). First line agent
for this condition is oral sulfamethoxazole/trimethoprim 800/160 mg once
daily.
Proven, Influenza A (including H1N1 2009 and H3N2) and Influenza B on
PCR requiring hospital admission where symptom onset < 48 hours
Patients admitted to Intensive Care Unit with clinical evidence of
ongoing/severe illness consistent with influenza where symptom onset <
48 hours.
Influenza-like-illness requiring hospital admission who belong to a group
vulnerable to severe outcomes of influenza where symptom onset < 48
hours
Please refer to prescribing protocol in HNE intranet
Cystic fibrosis acute exacerbation
Suspected or proven pseudomonal infection (usually with an
aminoglycoside once daily)
Limb-threatening diabetic foot infection
Limb threatening peripheral vascular disease in a non diabetic patient
Uncontrolled intra-abdominal sepsis (used as a single agent) after 5 days
of ampicillin, gentamicin and metronidazole
Intra-abdominal sepsis where gentamicin contraindicated (allergy or preexisting hearing or vestibular problem)
Hospital acquired pneumonia in HDU or ICU where patient admitted ≥5
days (6-hrly dosing frequency may be required)
Aspiration pneumonia > 5 days after admission
Systemic sepsis due to a suspected gastrointestinal/ biliary source
Febrile neutropenia
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Restricted Antibiotic
Rifabutin (oral)
Adult: 300 mg daily
Child: 5 mg/kg up to 300 mg
daily
Rifampicin (oral)
(See TG: Antibiotic for
dosing)
Restricted Anti-infective Indications HNEH CG 10_06
Accepted Indications and Comments
- Treatment of non-tuberculous Mycobacterium avium complex (MAC)
infection
-
Ticarcillin/Clavulanate (IV)
Vancomycin (IV)
Note: Changes to dosing
recommendations from
August 2010: See TG:
Antibiotic for dosing)
Prophylaxis:
See HNE Health Surgical
Prophylaxis Clinical Practice
Guideline)
Vancomycin (oral)
Adult: 125 mg 6-hrly
Child: 3 mg/kg up to 125 mg
6-hrly
Oral treatment for methicillin-resistant S. aureus with demonstrated
rifampicin sensitivity (must be used in conjunction with oral fusidic acid 500
mg 12-hrly)
Demonstrated mycobacterial infections
Neisseria meningitides or Haemophilus influenzae type b (Hib) prophylaxis
This drug is no longer stocked by John Hunter Hospital. Please see
“piperacillin/tazobactam” as an alternative agent
Treatment:
- Empiric treatment of infections suspected to be caused by beta-lactam
resistant Gram positive bacteria
- Directed treatment of infections caused by beta-lactam resistant Gram
positive bacteria
- Directed treatment of infections caused by other Gram positive bacteria in
patients with major beta-lactam allergy
Surgical prophylaxis
- Major surgical procedures in patients known to be colonised with MRSA. A
single dose administered just prior to surgery is sufficient unless the
procedure lasts more than 6 hours, in which case a second dose should be
given
- Second line endocarditis prophylaxis for genitourinary or gastrointestinal
procedures in patients with major beta-lactam allergy (i.e. those who can
not receive amoxycillin as first line agent)
- Third line endocarditis prophylaxis for dental or upper respiratory tract
interventions in patients unable to take the second line agent oral
clindamycin (first line is amoxycillin)
- Treatment of Clostridium difficile colitis that fails to respond to
metronidazole
- Severe and potentially life threatening C. difficile colitis (Consult Infectious
Diseases). Usually given in combination with intravenous metronidazole.
Note: Adult and paediatric CF patients who receive an aminoglycoside are dosed at 6am daily and require dose
modification based on Area Under the Curve (AUC) pharmacokinetic evaluation. For patients being dose at JHH
please contact the Immunology and Infectious Diseases Pharmacist (page: 5705) or consult Infectious Diseases or
Respiratory Medicine.
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Restricted Anti-infective Indications HNEH CG 10_06
IMPLEMENTATION PLAN
Area Antimicrobial Working Party is responsible for overall implementation. This group has developed a
strategic plan for 2010. Support for stewardship activities at remote sites is a key objective.
At John Hunter Hospital, GUIDANCE Implementation Committee formed to oversee process of implementation
of GUIDANCE-DS which is an essential element of restricted anti-infective management
Intensive care antimicrobial liaison rounds (twice weekly at JHH, weekly at other sites) will continue across HNE
Health at all intensive care units.
Area Clinical Practice Guidelines and pathways for pneumonia, S. aureus bloodstream infection, aminoglycoside
usage and surgical prophylaxis provide support for implementation.
HAPS Microbiologists provide specific support for restricted anti-infective indications by selective (cascade)
antimicrobial susceptibility reporting and direct clinician discussion over particular cases.
Infectious Diseases consultants provide advice to clinicians consistent with these guidelines, supporting their
use.
Facility Managers and Pharmacists are to be provided with annotated quarterly facility antimicrobial usage
reports that support targeted engagement of clinical staff.
The Area Antibiotic Guideline lays down the expectations of clinicians to
- follow Therapeutic Guidelines: Antibiotic and Area CPGs
- follow criteria for early consultation with Infectious Diseases in specific cases
Educational efforts to JMOs (Orientation sessions by Pharmacy and ID), Specialists, VMOs and GPs (Infection
Matters Newsletter) will be completed.
EVALUATION PLAN
Antimicrobial usage monitoring via National Program occurs at all Acute Networks site. These data are subject to
review by Pharmacy and the Area Antimicrobial Working Party.
Drug Usage Evaluation surveys are done regularly at Acute Networks sites to identify opportunities for
improvement and provide specific feedback to prescribers.
GUIDANCE-DS at John Hunter (to be implemented on July 1st 2010) will provide for close analysis of restricted
anti-infective prescription and use with timely feedback to prescribers.
CONSULATION WITH KEY STAKEHOLDERS
List of key stakeholder consulted including name and title
• Infectious Diseases and Immunology
• HAPS Microbiology
• Area Quality Use of Medicines Committee
• Anti-infective Working Group
REFERENCES
•
Therapeutic Guidelines: Antibiotic, Edition 14
Version One
September 2010
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