Download Use of AMR Surveillance Data to Develop Infectious Diseases

Use of AMR Surveillance Data
to Develop Infectious Diseases
Standard Treatment
Guidelines in Developing
Countries.
Sosa A., Stelling J., O’Brien T., Traub F., Travers K.,
Hodges Myerson A.
Problem Statement:
• Antimicrobial resistance (AMR) has spread
across regions and continents, resulting in
increased morbidity, mortality, and costs.
• Often, the use of practical clinical guidelines in
the management of key infectious diseases in the
developing world is hampered by the lack of
reliable antimicrobial surveillance data.
• When minimum requirements for AMR
surveillance are met, data obtained from
Antimicrobial Susceptibility Testing (AST) are
essential to provide more effective therapy
and minimize treatment failures .
Definition of Surveillance.
Surveillance is defined as the ongoing and
systematic collection, analysis and interpretation of
outcome-specific data essential to the planning,
implementation, and evaluation of public health
practice, closely integrated with the timely
dissemination of these data to those who need to
know. The final link of the surveillance chain is the
application of these data to the control and
prevention of human disease and injury.
Source: Australia Communicable Diseases Intelligence - Vol 27 No 4,
December 2003
Benefits of AMR Surveillance.
 characterization of disease etiologies and resistance trends
 prompt identification and investigation of new threats in
resistance
 guidance to policy-makers in developing therapy
recommendations
 guidance to public health authorities in responding to
outbreaks of community and hospital outbreaks of resistant
organisms
 evaluation of the impact of therapy and infection control
interventions on infection rates and cure rates
 strengthening of laboratory capacity and national
communicable disease infrastructure through a process of
continuous quality improvement
Limitations of AMR Surveillance.
 In sentinel and designed studies often expensive and
labor-intensive with significant concerns for longterm sustainability
 laboratory data could be flawed and mislead
intervention strategies
 epidemiological biases (representative of patients
and samples)
 need to set up internal and external quality assurance
 translating data “in-vitro” to “in-vivo”
 it requires trained personnel and standard protocol
Objectives:
To develop a guide to help the National
Standard Treatment Guideline (STG)
committee to utilize AMR surveillance data
to write and update STGs. The incorporation
of surveillance data into STGs produces:
1) Better resource allocation of drugs by
identifying inappropriate antimicrobials;
2) Appropriate access to essential
antimicrobials;
3) Prudent use of antimicrobials by
practitioners.
Setting:
Developing country with minimum AMR surveillance
system in place.
Design (1): Qualitative analysis.
The country’s AMR Surveillanceinfrastructure
and specific disease environment were
analyzed through:
1) Assessment of country AST and Quality Control
Systems;
2) Assessment of the AMR surveillance country
system;
3) Definition of AMR Alert Thresholds for key
pathogens;
4) Definition of disease-specific therapy
thresholds;
Design (2):
5) Assessment of regional and global AMR
surveillance data for same key pathogens;
6) Assessment of health care infrastructure for
drug procurement, transport, storage and
delivery;
7) Application of WHO Bacterial Infections
Guide.
Intervention:
Production of a guide using local AMR data to
inform the process of writing and updating the
country’s STGs for the most prevalent bacterial
infections responsible for ARI, diarrheal disease
and sexually transmitted infections (STIs) in
developing countries.
Outcome Measures:
1) Better understanding of the use of AMR data;
2) Better access and use of antimicrobials;
3) Reduction in the rate of increase of AMR in
key pathogens.
Study Funding: USAID via Management Sciences for Health
Resistance alert thresholds
The maximum allowable prevalence of resistant
bacteria isolated from a group of patients that
does not pose an unacceptable risk to general
human health population receiving the drug of
choice.
Thresholds for Action in a Specific Setting
Defined
• *5% resistance for N. gonorrhoeae
• *Beta lactamase producing meningococcus
• *1% resistance for Rx of meningitis
• *First pen-resistant Strep pyogenes
Undefined (most)
• ?Multi-drug resistant TB ?%
John Tapsall
Disease-specific thresholds
The maximum allowable severity of certain
disease-specific symptoms and signs that does
not require antimicrobial treatment.
Example:
• Severity of dehydration in Cholera
Patient
Entry
Empirical selection of an antibiotic in nonoutbreak Vibrio cholerae infections in Nepal
at the sub-health and health posts
Sub-health &
health posts
Available ATBs
TMP-SMX
Tetracycline
Chloramphenicol
Benzyl Penicillin
Questions
Is patient a child, an adult
or a pregnant woman?
Action Threshold
Severity
of
dehydration
Alert threshold
V. cholereae
Resistance Prevalence
TMP-SMX 20%
Chloramphenicol 20%
Tetracycline 10%
If available at the post, Erythromycin
Child
Adult
TMP-SMX
Tetracycline
or TMP-SMP
or Chloramphenicol
Child
Adult
Pregnant Woman
TMP-SMP
or
Tetracycline
if pregnancy  3 months
Pregnant Woman
Doxycline or Ciprofloxacin (both contraindicated in pregnancy)
WHO PRESCRIBING GUIDE FOR BACTERIAL INFECTIONS
Patient
Entry
Empirical selection of an antibiotic in nonoutbreak Vibrio cholerae infections in Nepal
at the district level
District Level
Questions
Is patient a child, an adult
or a pregnant woman?
Action Threshold
Severity
of
dehydration
Alert threshold
V. cholereae
Resistance Prevalence
TMP-SMX 20%
Chloramphenicol 20%
Tetracycline 10%
Available ATBs
Amoxicillin ,TMP-SMX, Tetracycline,
Chloramphenicol, Benzyl Penicillin,
Cloxacillin, Erythromycin,
Ciprofloxacin, Gentamicin,
Metronidazole, Rifampicin,
Streptomycin, Ethambutol,
Sulfaacetamide, Doxycycline,
Nitrofurantoin
If available at the post, Erythromycin
Child
Adult
TMP-SMX
Tetracycline
or TMP-SMP
or Chloramphenicol
Child
Adult
Pregnant Woman
TMP-SMP
or
Tetracycline
if pregnancy  3 months
Pregnant Woman
Doxycline or Ciprofloxacin (both contraindicated in pregnancy)
WHO PRESCRIBING GUIDE FOR BACTERIAL INFECTIONS
Patient
Entry
Empirical selection of an antibiotic in nonoutbreak Vibrio cholerae infections in Nepal
at the national level
District Level
Questions
Is patient a child, an adult
or a pregnant woman?
Action Threshold
Severity
of
dehydration
Alert threshold
V. cholereae
Resistance Prevalence
TMP-SMX 20%
Chloramphenicol 20%
Tetracycline 10%
Available ATBs
Amoxicillin ,TMP-SMX, Tetracycline,
Chloramphenicol, Benzyl Penicillin,
Cloxacillin, Erythromycin,
Ciprofloxacin, Gentamicin,
Metronidazole, Rifampicin,
Streptomycin, Ethambutol,
Sulfaacetamide, Doxycycline,
Nitrofurantoin, Cefotaxime
If available at the post, Erythromycin
Child
Adult
TMP-SMX
Tetracycline
or TMP-SMP
or Chloramphenicol
Child
Adult
Pregnant Woman
TMP-SMP
or
Tetracycline
if pregnancy  3 months
Pregnant Woman
Doxycline or Ciprofloxacin (both contraindicated in pregnancy)
WHO PRESCRIBING GUIDE FOR BACTERIAL INFECTIONS
Discussion: issues to be considered (1)
1.
What are the challenging methodological issues?
 Dealing with the inherent biases in the
bacterial samples collected for AST, whether
they are geographical, economic, medical,
demographic, clustered around one time or
outbreak.
 Defining alert thresholds
 Defining disease-specific therapy thresholds
Discussion: issues to be considered (2)
2.
Which methods questions should be included in a
future research agenda?
 Assessing the effect of losses-to-follow-up
when evaluating the effect of STG
implementation on treatment success/failure
rates.
 Another methodological issue to consider in
the future development of STGs is that of
observation bias: will prescribers alter their
practice based solely on their participation in
a study?
Selected References:
1.
Wachter, D., M. Joshi, and B. Rimal,. Tropical Medicine and International Health, 1999. 4(11): p.
782-788.
2.
Rehana, H.S., M.A. Nagarani, and M. Rehan, Indian Journal of Pharmacology, 1998. 30: p. 175180.
3.
Kafle, K., et al., Community drug use in Nepal. 1997.
4.
Nair, G., A. Hossain, and M. Rahman, 2002, ICCDR,B Center for Health & Population Research:
Dakar, Bangladesh.
5.
Stelling, J.M. and T.F. O'Brien. Clin Infect Dis, 1997. 24 Suppl 1: p. S157-68.
6.
Nepal, M.o.H., Standard Treatment Schedules for Health Posts & Sub-Health Posts. 1999,
Bagbazar, Kathmandu.
7.
Ashkenazi, S., et al., J. Antimicrob. Chemother., 2003. 51(2): p. 427-429.
8.
Honma, Y., et al., FEMS Immunol Med Microbiol, 2001. 32(1): p. 43-6.
9.
Jesudason, M.V., V. Balaji, and C.J. Thomson. Indian J Med Res, 2002. 116: p. 96-8.
10.
WHO, Model Prescribing Information. Drugs used for bacterial infections. 2001, World Health
Organization: Geneva, Switzerland
11.
Tapsall, J., Expert Opin Pharmacother, 2002. 3(2): p. 147 - 157.
12.
MMWR, 2002. 51(46): p. 1041-1044.
13.
WHO. Commun Dis Intell, 2001. 25(4): p. 274-6.
14.
APUA. April 2003. Framework for Use of Antimicrobial Resistance Surveillance in the Development of
Standard Treatment Guidelines.
Acknowledgment:
• Allison Hodges Myerson, M.Sc., M.A., APUA Research Coord.
• Thomas O’Brien, MD., WHO Collaborating Centre for Surveillance of
Antibiotic Resistance, Boston
• John Stelling, MD, MPH., WHO Collaborating Centre for Surveillance of
Antibiotic Resistance, Boston
• Karin Travers, ScD., APUA Research Manager
• Flora Traub, MPP, APUA International Coord.
• G. B. Nair, ICCDR, Bangladesh
• Anowar Hossain, ICCDR, Bangladesh
• Motiur Rahman, ICCDR, Bangladesh
Thank You!
Anibal Sosa, MD.
[email protected]
Alliance for the Prudent Use
of Antibiotics (APUA)
75 Kneeland Street
Boston, MA 02111, USA
www.apua.org