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Antimicrobial Prophylaxis for Transrectal Prostate Biopsy: Organizational Recommendations J. Stuart Wolf, Jr., M.D. Antimicrobial Prophylaxis for Transrectal Prostate Biopsy: Organizational Recommendations J. Stuart Wolf, Jr., M.D.

Antimicrobial Prophylaxis for Transrectal Prostate · PDF fileAntimicrobial Prophylaxis for Transrectal Prostate Biopsy: Organizational Recommendations J. Stuart Wolf, Jr., M.D. Department

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Page 1: Antimicrobial Prophylaxis for Transrectal Prostate · PDF fileAntimicrobial Prophylaxis for Transrectal Prostate Biopsy: Organizational Recommendations J. Stuart Wolf, Jr., M.D. Department

Antimicrobial Prophylaxis

for Transrectal

Prostate Biopsy:

Organizational

Recommendations

J. Stuart Wolf, Jr., M.D.

Antimicrobial Prophylaxis

for Transrectal

Prostate Biopsy:

Organizational

Recommendations

J. Stuart Wolf, Jr., M.D.

Page 2: Antimicrobial Prophylaxis for Transrectal Prostate · PDF fileAntimicrobial Prophylaxis for Transrectal Prostate Biopsy: Organizational Recommendations J. Stuart Wolf, Jr., M.D. Department

Department of Urology

University of Michigan

Ann Arbor, MI

Department of Urology

University of Michigan

Ann Arbor, MI

Page 3: Antimicrobial Prophylaxis for Transrectal Prostate · PDF fileAntimicrobial Prophylaxis for Transrectal Prostate Biopsy: Organizational Recommendations J. Stuart Wolf, Jr., M.D. Department

Official Recommendations for Prophylaxis

Organizations (other than AUA)

� Canadian Urological Association (CUA)

� European Association of Urology (EAU)

� National Comprehensive Cancer Network

(NCCN)

� Center for Medicare & Medicaid Surgical

Care Improvement Project (CMS-SCIP)

� American Medical Association Physician

Consortium for Performance Improvement

(AMA-PCPI) (creates measures, including

- among others - for Physician Quality

Reporting System [PQRS])

Organizations (other than AUA)

� Canadian Urological Association (CUA)

� European Association of Urology (EAU)

� National Comprehensive Cancer Network

(NCCN)

� Center for Medicare & Medicaid Surgical

Care Improvement Project (CMS-SCIP)

� American Medical Association Physician

Consortium for Performance Improvement

(AMA-PCPI) (creates measures, including

- among others - for Physician Quality

Reporting System [PQRS])

Page 4: Antimicrobial Prophylaxis for Transrectal Prostate · PDF fileAntimicrobial Prophylaxis for Transrectal Prostate Biopsy: Organizational Recommendations J. Stuart Wolf, Jr., M.D. Department

Principles of Antimicrobial Prophylaxis

Principles of Surgical Prophylaxis

� “Surgical antimicrobial prophylaxis is

the periprocedural systemic

administration of an antimicrobial

agent intended to reduce the risk of

postprocedural local and systemic

infections.”

Principles of Surgical Prophylaxis

� “Surgical antimicrobial prophylaxis is

the periprocedural systemic

administration of an antimicrobial

agent intended to reduce the risk of

postprocedural local and systemic

infections.”

Page 5: Antimicrobial Prophylaxis for Transrectal Prostate · PDF fileAntimicrobial Prophylaxis for Transrectal Prostate Biopsy: Organizational Recommendations J. Stuart Wolf, Jr., M.D. Department

Principles of Antimicrobial Prophylaxis

Other Measures to Reduce Biopsy-Related Infections

� Bowel preparation (entire bowel)

� Sterile preparation of rectum

� Cleansing enema

� Dipping needle in cleansing solution

� Others

Other Measures to Reduce Biopsy-Related Infections

� Bowel preparation (entire bowel)

� Sterile preparation of rectum

� Cleansing enema

� Dipping needle in cleansing solution

� Others

Page 6: Antimicrobial Prophylaxis for Transrectal Prostate · PDF fileAntimicrobial Prophylaxis for Transrectal Prostate Biopsy: Organizational Recommendations J. Stuart Wolf, Jr., M.D. Department

Principles of Antimicrobial Prophylaxis

Principles of Surgical Prophylaxis

� “The potential benefit of surgical

antimicrobial prophylaxis is

determined by 3 considerations:

patient-related factors (ability of the

host to respond to bacterial

invasion), procedural factors

(likelihood of bacterial invasion at

the operative site), and the potential

morbidity of infection.”

Principles of Surgical Prophylaxis

� “The potential benefit of surgical

antimicrobial prophylaxis is

determined by 3 considerations:

patient-related factors (ability of the

host to respond to bacterial

invasion), procedural factors

(likelihood of bacterial invasion at

the operative site), and the potential

morbidity of infection.”

Page 7: Antimicrobial Prophylaxis for Transrectal Prostate · PDF fileAntimicrobial Prophylaxis for Transrectal Prostate Biopsy: Organizational Recommendations J. Stuart Wolf, Jr., M.D. Department

Principles of Antimicrobial Prophylaxis

Surgical Wound Classifications

� Clean

� Uninfected, primary closure

� Clean-contaminated

� Respiratory, alimentary, genital, or

urinary tracts

� Contaminated

� Dirty-infected

Surgical Wound Classifications

� Clean

� Uninfected, primary closure

� Clean-contaminated

� Respiratory, alimentary, genital, or

urinary tracts

� Contaminated

� Dirty-infected

Page 8: Antimicrobial Prophylaxis for Transrectal Prostate · PDF fileAntimicrobial Prophylaxis for Transrectal Prostate Biopsy: Organizational Recommendations J. Stuart Wolf, Jr., M.D. Department

Principles of Antimicrobial Prophylaxis

Surgical Wound Classifications

� Clean

� Uninfected, primary closure

� Clean-contaminated

� Respiratory, alimentary, genital, or

urinary tracts

� Contaminated

� Dirty-infected

Surgical Wound Classifications

� Clean

� Uninfected, primary closure

� Clean-contaminated

� Respiratory, alimentary, genital, or

urinary tracts

� Contaminated

� Dirty-infected

Page 9: Antimicrobial Prophylaxis for Transrectal Prostate · PDF fileAntimicrobial Prophylaxis for Transrectal Prostate Biopsy: Organizational Recommendations J. Stuart Wolf, Jr., M.D. Department

Principles of Antimicrobial Prophylaxis

Principles of Surgical Prophylaxis

� “Surgical antimicrobial prophylaxis is

recommended only when the

potential benefit exceeds the risks

and anticipated costs.”

Principles of Surgical Prophylaxis

� “Surgical antimicrobial prophylaxis is

recommended only when the

potential benefit exceeds the risks

and anticipated costs.”

Page 10: Antimicrobial Prophylaxis for Transrectal Prostate · PDF fileAntimicrobial Prophylaxis for Transrectal Prostate Biopsy: Organizational Recommendations J. Stuart Wolf, Jr., M.D. Department

Principles of Antimicrobial Prophylaxis

Costs

� Financial

� Expense of administration, expense

of treating adverse outcomes

� Personal-health

� Allergic reactions, antimicrobial-

associated superinfection

� Public-health

� Induction of bacterial resistance

Costs

� Financial

� Expense of administration, expense

of treating adverse outcomes

� Personal-health

� Allergic reactions, antimicrobial-

associated superinfection

� Public-health

� Induction of bacterial resistance

Page 11: Antimicrobial Prophylaxis for Transrectal Prostate · PDF fileAntimicrobial Prophylaxis for Transrectal Prostate Biopsy: Organizational Recommendations J. Stuart Wolf, Jr., M.D. Department

Principles of Antimicrobial Prophylaxis

Principles of Surgical Prophylaxis

� “The antimicrobial agent used for

prophylaxis should be effective

against the disease-relevant bacterial

flora characteristic of the operative

site. Cost, convenience, and safety

of the agent also should be

considered.”

Principles of Surgical Prophylaxis

� “The antimicrobial agent used for

prophylaxis should be effective

against the disease-relevant bacterial

flora characteristic of the operative

site. Cost, convenience, and safety

of the agent also should be

considered.”

Page 12: Antimicrobial Prophylaxis for Transrectal Prostate · PDF fileAntimicrobial Prophylaxis for Transrectal Prostate Biopsy: Organizational Recommendations J. Stuart Wolf, Jr., M.D. Department

Principles of Antimicrobial Prophylaxis

Principles of Surgical Prophylaxis

� “The duration of surgical

antimicrobial prophylaxis should

extend throughout the period in

which bacterial invasion is facilitated

and/or is likely to establish an

infection.”

Principles of Surgical Prophylaxis

� “The duration of surgical

antimicrobial prophylaxis should

extend throughout the period in

which bacterial invasion is facilitated

and/or is likely to establish an

infection.”

Page 13: Antimicrobial Prophylaxis for Transrectal Prostate · PDF fileAntimicrobial Prophylaxis for Transrectal Prostate Biopsy: Organizational Recommendations J. Stuart Wolf, Jr., M.D. Department

Principles of Antimicrobial Prophylaxis

Duration of Therapy

� Infusion of first dose should begin

within 60 minutes of the surgical

incision (with the exception of 120

minutes for intravenous

fluoroquinolones and vancomycin)

� Single dose, or at the most

discontinued within 24 hours

� Potential caveat for prostate biopsy7

Duration of Therapy

� Infusion of first dose should begin

within 60 minutes of the surgical

incision (with the exception of 120

minutes for intravenous

fluoroquinolones and vancomycin)

� Single dose, or at the most

discontinued within 24 hours

� Potential caveat for prostate biopsy7

Page 14: Antimicrobial Prophylaxis for Transrectal Prostate · PDF fileAntimicrobial Prophylaxis for Transrectal Prostate Biopsy: Organizational Recommendations J. Stuart Wolf, Jr., M.D. Department

Principles of Antimicrobial Prophylaxis

Duration of Therapy

� Existing infection (contaminated field)

� Options

–Give full course to sterilize

– If not possible, aim to suppress

bacterial count

� Neither option is reasonably

feasible for transrectal biopsy

Duration of Therapy

� Existing infection (contaminated field)

� Options

–Give full course to sterilize

– If not possible, aim to suppress

bacterial count

� Neither option is reasonably

feasible for transrectal biopsy

Page 15: Antimicrobial Prophylaxis for Transrectal Prostate · PDF fileAntimicrobial Prophylaxis for Transrectal Prostate Biopsy: Organizational Recommendations J. Stuart Wolf, Jr., M.D. Department

Official Recommendations for Prophylaxis

CUA

� 2010 Guidelines on Prostate Biopsy

Methodology

� “Broad-based gram-negative antibiotic

prophylaxis (e.g., fluorquinolone)

should be administered prior to

biopsy and may be continued for 2 to

3 days post-biopsy 7 many centres

have moved towards shorter courses

of antibacterial prophylaxis.”

CUA

� 2010 Guidelines on Prostate Biopsy

Methodology

� “Broad-based gram-negative antibiotic

prophylaxis (e.g., fluorquinolone)

should be administered prior to

biopsy and may be continued for 2 to

3 days post-biopsy 7 many centres

have moved towards shorter courses

of antibacterial prophylaxis.”

Page 16: Antimicrobial Prophylaxis for Transrectal Prostate · PDF fileAntimicrobial Prophylaxis for Transrectal Prostate Biopsy: Organizational Recommendations J. Stuart Wolf, Jr., M.D. Department

Official Recommendations for Prophylaxis

EAU

� 2013 Guidelines on Prostate Cancer

� “Oral or intravenous antibiotics are

state of the art treatment”

� “Quinolones are the drugs of choice

7 but in the last few years increased

resistance to quinolones has been

reported”

EAU

� 2013 Guidelines on Prostate Cancer

� “Oral or intravenous antibiotics are

state of the art treatment”

� “Quinolones are the drugs of choice

7 but in the last few years increased

resistance to quinolones has been

reported”

Page 17: Antimicrobial Prophylaxis for Transrectal Prostate · PDF fileAntimicrobial Prophylaxis for Transrectal Prostate Biopsy: Organizational Recommendations J. Stuart Wolf, Jr., M.D. Department

Official Recommendations for Prophylaxis

EAU

� 2013 Guidelines on Urological

Infections

� “Antimicrobial prophylaxis 7 is

generally recommended”

� “The choice of regimens remains

debatable.”

� “1-day and even single doses are

sufficient in low-risk patients.”

EAU

� 2013 Guidelines on Urological

Infections

� “Antimicrobial prophylaxis 7 is

generally recommended”

� “The choice of regimens remains

debatable.”

� “1-day and even single doses are

sufficient in low-risk patients.”

Page 18: Antimicrobial Prophylaxis for Transrectal Prostate · PDF fileAntimicrobial Prophylaxis for Transrectal Prostate Biopsy: Organizational Recommendations J. Stuart Wolf, Jr., M.D. Department

Official Recommendations for Prophylaxis

EAU

� 2013 Guidelines on Urological

Infections

� “Increase in fluoroquinolone

resistance has raised the question

of appropriateness of current

recommendations.”

� “No clear cut alternative is evidence-

based.”

� “Consider the need for a rectal

swab.”

EAU

� 2013 Guidelines on Urological

Infections

� “Increase in fluoroquinolone

resistance has raised the question

of appropriateness of current

recommendations.”

� “No clear cut alternative is evidence-

based.”

� “Consider the need for a rectal

swab.”

Page 19: Antimicrobial Prophylaxis for Transrectal Prostate · PDF fileAntimicrobial Prophylaxis for Transrectal Prostate Biopsy: Organizational Recommendations J. Stuart Wolf, Jr., M.D. Department

Official Recommendations for Prophylaxis

NCCN

� 2013 Prostate Cancer

� No recommendations about

antimicrobial prophylaxis

� In Discussion section,

fluoroquinolone resistance is

mentioned

NCCN

� 2013 Prostate Cancer

� No recommendations about

antimicrobial prophylaxis

� In Discussion section,

fluoroquinolone resistance is

mentioned

Page 20: Antimicrobial Prophylaxis for Transrectal Prostate · PDF fileAntimicrobial Prophylaxis for Transrectal Prostate Biopsy: Organizational Recommendations J. Stuart Wolf, Jr., M.D. Department

Official Recommendations for Prophylaxis

NCCN

� 2012 Prostate Cancer Early Detection

� No specific recommendations about

antimicrobial prophylaxis

� In Discussion section,

fluoroquinolone resistance and

possible use of rectal swabs are

mentioned

NCCN

� 2012 Prostate Cancer Early Detection

� No specific recommendations about

antimicrobial prophylaxis

� In Discussion section,

fluoroquinolone resistance and

possible use of rectal swabs are

mentioned

Page 21: Antimicrobial Prophylaxis for Transrectal Prostate · PDF fileAntimicrobial Prophylaxis for Transrectal Prostate Biopsy: Organizational Recommendations J. Stuart Wolf, Jr., M.D. Department

Official Recommendations for Prophylaxis

AUA (updated 1/1/2014)

� All regimens ≤ 24 hours

� First line

� Oral fluoroquinolone

� IV / IM 1st / 2nd / 3rd gen. cephalosporin

� Alternatives

� Oral TMP-SMX (as of 1/1/14)

� IV / IM aminoglycoside or aztreonam

� (clindamycin and metronidazole

removed as of 1/1/14)

AUA (updated 1/1/2014)

� All regimens ≤ 24 hours

� First line

� Oral fluoroquinolone

� IV / IM 1st / 2nd / 3rd gen. cephalosporin

� Alternatives

� Oral TMP-SMX (as of 1/1/14)

� IV / IM aminoglycoside or aztreonam

� (clindamycin and metronidazole

removed as of 1/1/14)

Page 22: Antimicrobial Prophylaxis for Transrectal Prostate · PDF fileAntimicrobial Prophylaxis for Transrectal Prostate Biopsy: Organizational Recommendations J. Stuart Wolf, Jr., M.D. Department

Official Recommendations for Prophylaxis

AUA Deliberations with CMS-SCIP

� Need for Urology-specific antimicrobial

prophylaxis regimens was primary

impetus for the creation of AUA’s 2008

Best Practice Policy Statement on

Urologic Surgery Antimicrobial

Prophylaxis

� AUA has worked closely with CMS-SCIP

to harmonize recommendations

� CMS-SCIP and AUA recommendations

are identical

AUA Deliberations with CMS-SCIP

� Need for Urology-specific antimicrobial

prophylaxis regimens was primary

impetus for the creation of AUA’s 2008

Best Practice Policy Statement on

Urologic Surgery Antimicrobial

Prophylaxis

� AUA has worked closely with CMS-SCIP

to harmonize recommendations

� CMS-SCIP and AUA recommendations

are identical

Page 23: Antimicrobial Prophylaxis for Transrectal Prostate · PDF fileAntimicrobial Prophylaxis for Transrectal Prostate Biopsy: Organizational Recommendations J. Stuart Wolf, Jr., M.D. Department

Official Recommendations for Prophylaxis

AUA Deliberations with CMS-SCIP

� AUA has successfully proposed:

� Addition of IV 1st gen. cephalosporins

� Addition of IM route

� Addition of oral TMP-SMX (!)

� Removal of clindamycin and

metronidazole

� AUA has failed to get accepted:

� Oral cephalosporins

� Rectal swabs

AUA Deliberations with CMS-SCIP

� AUA has successfully proposed:

� Addition of IV 1st gen. cephalosporins

� Addition of IM route

� Addition of oral TMP-SMX (!)

� Removal of clindamycin and

metronidazole

� AUA has failed to get accepted:

� Oral cephalosporins

� Rectal swabs

Page 24: Antimicrobial Prophylaxis for Transrectal Prostate · PDF fileAntimicrobial Prophylaxis for Transrectal Prostate Biopsy: Organizational Recommendations J. Stuart Wolf, Jr., M.D. Department

Official Recommendations for Prophylaxis

AUA Deliberations with AMA-PCPI

� AMA-PCPI not willing to harmonize

recommendations with AUA

� AUA felt that a bad measure was worse

than no measure at all !

� In July 2013, in response to AUA

request, AMA-PCPI agreed to

recommend to CMS that CPT codes

55700 and 55706 be dropped from PQRS

#20: Timing of Antibiotic Prophylaxis-

Ordering Physician

AUA Deliberations with AMA-PCPI

� AMA-PCPI not willing to harmonize

recommendations with AUA

� AUA felt that a bad measure was worse

than no measure at all !

� In July 2013, in response to AUA

request, AMA-PCPI agreed to

recommend to CMS that CPT codes

55700 and 55706 be dropped from PQRS

#20: Timing of Antibiotic Prophylaxis-

Ordering Physician

Page 25: Antimicrobial Prophylaxis for Transrectal Prostate · PDF fileAntimicrobial Prophylaxis for Transrectal Prostate Biopsy: Organizational Recommendations J. Stuart Wolf, Jr., M.D. Department

Official Recommendations for Prophylaxis

Are the official organizational

recommendations sufficient to

direct best practice?

Are the official organizational

recommendations sufficient to

direct best practice?