Antibiotic policy and trends in antibiotic policy, References Infection control: Basic concepts and practices, 2nd edn. www.cdc.org Antibiotics guide: choices for common infections Chennai Declaration

1. ANTIBIOTIC POLICY
Dr Md Ashraf Ali

2. • INTRODUCTION
• DEFINITION
• AIMS AND OBJECTIVES
• INDIAN SCENARIO
• HOSPITALANTIBIOTIC COMMITTEE
– Formation, Key Members And Functions
• HOSPITALANTIBIOTIC POLICY
– Policy For Emperical And Prophylactic Therapy
• ROLE OF MICROBIOLOGY DEPARTMENT
• WHONET
• LONG TERM GOALS- Role of MCI
• SUMMARY AND CONCLUSION
Dr Md Ashraf Ali

3. “But I would like to sound one note of warning.
Penicillin is to all intents non-poisonous so there is no need to worry
about giving an overdose and poisoning the patient.There may be a
danger, though, in underdosage.
The time may come when penicillin can be bought by anyone in shops,
an ignorant man may easily underdose himself and by exposing his
microbes to non-lethal quantities of the drug, makes them resistant.”
Sir Alexander Fleming
http://www.nobelprize.org/nobel_prizes/medicine/laureates/1945/fleming-lecture
Dr Md Ashraf Ali

4. Introduction
“Over the counter” antibiotics
• Improper use/misuse of antibiotics
• Inappropriate prescription
• Sale not restricted to medical prescription only.
Dr Md Ashraf Ali

5. What is Misuse
of Antibiotics?
• DOSAGE: Incorrect dosage
• DURATION: too short or too long
• DELAY: antibiotic administration in critically ill patients
• DATA: treatment if not streamlined as per culture and
DST results.
5
Dr Md Ashraf Ali

6. Inappropriate
prescription
• >40% of all antimicrobials prescribed in teaching
hospitals were considered inappropriate
• Prescribing antibiotics for viral infections
• broad-spectrum antibiotics are used too generously prior
to first choice drugs
Dr Md Ashraf Ali

7. • This unnecessary use / inappropriate use of antibiotics
encourages the selection and proliferation of resistant
bacterial strains.
• These Spread to other patients (cross infection).
• Transferred between bacterial species
Dr Md Ashraf Ali

8. • Drug resistance- evolutionary phenomenon
• Not possible to completely eliminate it
• Possible to modify or slow it down by prudent
antibiotic usage.
• Hence importance of inclusion of an antibiotic policy
in the infection control program.
Dr Md Ashraf Ali

9. A solution to the evolutionary
phenomen
ANTIBIOTIC POLICY
Dr Md Ashraf Ali

10. Definition
• An antibiotic policy consists of written guidance that
recommends antibiotics and their dose for treating
and preventing specific infections.
Dr Md Ashraf Ali

11. • In general a hospital antibiotic policy covers
empirical treatment, specific treatment and also
agents for prophylaxis.
• It constitutes one of the most important aspects of
Infection Control program.
• It is evidence based and is drafted by a committee
“The Hospital Infection Control Committee” or
“Hospital Antibiotic Committee”
Dr Md Ashraf Ali

12. Aims and objectives
• Improve patient care
• Better use of resources
• Retard the emergence & spread of drug resistant bacteria.
• Improve education of junior doctors
• Avoid wasteful expenditure of government/ NGOs.
Dr Md Ashraf Ali

13. Indian scenario
Dr Md Ashraf Ali

14. Government hospitals
• Nosocomial infection rate is as high as 40-50%.
• There is an URGENT NEED or a concerted effort to
control and prevent development of drug resistance
within hospital setting.

15. NABH DATA on Indian Hospitals
As per data available from NABH assessors
“most accredited hospitals, though having a well written
antibiotic policy on paper, are not compliant in practice.”
108

16. HOSPITAL ANTIBIOTIC
COMMITTEE
Dr Md Ashraf Ali

17. Hospital antibiotic committee
Formation:
 Medical director / Hospital superintendent should
ensure formation of this committee.
 Implementation of policies drafted by this committee
throughout the hospital.
 Stand alone or subcommittee of Hospital Infection
Control Committee
Dr Md Ashraf Ali

18. Key members of antibiotic
committee
• Physician
• Clinical microbiologist
• Clinical Pharmacologist
• Pharmacist
• Member of hospital management
• Member of Infection Control Committee
Dr Md Ashraf Ali

19. Functions of Antibiotic committee
1. To advice on antibiotic use & audit prescribing
2. Formulary restriction and preauthorization
3. Make rational choices amongst “equivalent drugs” &
classes of drugs “least expensive and most effective”.
Patient saves Money
Doctors save Lives.

20. How to choose the antibiotics ?
• Written by national experts
• Regularly updated every 2 years
• Recommendations concerning the
treatment of choice for common
clinical problems
Dr Md Ashraf Ali

21. HOSPITAL ANTIBIOTIC
POLICY
Dr Md Ashraf Ali

22. Policy for EMPERICAL treatment
• Simple, clear and clinically relevant
• Should include optimal dosage, route of administration,
duration, ALTERNATIVES for patients allergic to first
line drugs
• May be ward specific
• Should include levels of prescription
Dr Md Ashraf Ali

23. Levels of prescription
1. First choice drugs:
can be prescribed by all clinicians working in that hospital.
2. Restricted list of antibiotics:
only after permission from Head of department, clinical
microbiologist, Antibiotic committee representative
3. Reserve antibiotics:
only after permission from Hospital Antibiotic Committee.
Dr Md Ashraf Ali

24. 1. First choice antibiotics
• Also called Unreserved antibiotics
• Directed against specific diseases

25. Typhoid fever
First choice:
3rd generation cephalosporin
or
Azithromycin
Alternatives
• Cotrimoxazole
• Chloramphenicol
Dr Md Ashraf Ali

26. Respiratory tract infections
Disease First choice drug
COPD
• mild exacerbations
• if assoc. with purulent sputum,
dyspnea
Not necessary (Viral origin)
Doxycycline 100mg OD
Amoxicillin 500mg TID
PERTUSIS Azithromycin 500mg OD
Erythromycin
Pneumonia (adult) Amoxicillin
Roxithromycin
Doxycycline
Levofloxacin
Pneumonia (child) Amoxicillin
Erythromycin

27. Ear, nose, throat infections
INFECTION DRUG TO BE USED
OTITIS EXTERNA
•Topical ACETIC ACID 2% (mild cases)
•Ciprofloxacin 500mg BD oral
OTITIS MEDIA
•Antibiotics not advised
•If associated with perforation and otorrhea
Amoxicillin-clavulinic acid
PHARYNGITIS •Erythromycin 400mg
SINUSITIS
•Doxycycline 100mg OD
•Amox-clav

28. Urinary tract infection
First line
• Norfloxacin
• Nalidixic acid
Alternatives
• Cotrimoxazole
• Cefpodoxime
E. coli
Dr Md Ashraf Ali

29. Eye infections
Conjunctivitis ( Allergic, Viral / bacterial infection)
If bacterial cause suspected (mucopurulent discharge)
• Gentamicin 2% eye drops
• Chloramphenicol eye drops
Dr Md Ashraf Ali

30. CNS infections
• Meningoencephalitis- viral origin
• Bacterial meningitis
 Ceftriaxone and Amikacin combination
Dr Md Ashraf Ali

31. Skin infections
Disease Drug
Bites (Human / animal) • Augmentin
• Metronidazole + Doxycycline
• Metronidazole + co-trimoxazole
Boils, Cellulitis • Flucloxacillin
• Augmentin
• Cotrimoxazole
Diabetic foot • Augmentin
• Cephelexin + Metronidazole
• Cotrimoxazole + clindamycin
Impetigo • Fusidic acid cream 2%
• Oral Cotrimoxazole
Recurrent skin infections • Fusidic acid cream 2%
• Mupirocin

32. Gastrointestinal tract infections
Disease Drug
Diarrhea No antibiotics
Dysentery Ofloxacin + ornidazole/tinidazole
Dr Md Ashraf Ali

33. Policy for EMPERICAL treatment
Levels of prescription
1. First choice drugs: can be prescribed by all Dr.
2. Restricted list of antibiotics: only after permission
from Head of Department, clinical microbiologist,
Antibiotic committee representative
3. Reserve antibiotics: only after permission from
hospital antibiotic committee.
Dr Md Ashraf Ali

34. 2. Restricted list
1. Imipenem/Meropenem :
• Used for empirical in very sick patients
• Stop after culture and sensitivity report is available,
if it shows a susceptible pathogen to other classes of
Antibiotics & if patient condition improves.
2. Piperacillin-Tazobactam:
• These have a broad spectrum as carbapenems .
• Used for empirical in very sick patients.
Dr Md Ashraf Ali

35. 3. Vancomycin/Teicoplanin:
• Use as empirical in sick patients may be allowed
where MRSA is prevalent.
• After 48-72hrs culture and sensitivity report
shows no staph aureus or MSSA then they have
absolutely no role and should be discontinued.
Dr Md Ashraf Ali

36. Policy for EMPERICAL treatment
Levels of prescription
1. First choice drugs: can be prescribed by all Dr.
2. Restricted list of antibiotics: only after permission
from HOD, clinical microbiologist, Antibiotic
committee representative
3. Reserve antibiotics: only after permission from
Hospital Antibiotic Committee.
Dr Md Ashraf Ali

37. 3. Reserve drugs
1. Colistin:
• last resort for managing gram negative MDRs and
its use, dose and duration needs to be rationalized.
• Liberal use should be restricted
2. Doripenem: (FDA approval 2007)
• It is the last FDA approved carbapenem.
• If Imipenem and Doripenem are working, we need
to conserve Doripenem
Dr Md Ashraf Ali

38. 3. Rifampicin:
• Valuable drug for Tuberculosis.
• The use of rifampicin in MDR Pseudomonas,
Acinetobacter or MRSA should be restricted.
4. Linezolid:
• Bacteriostatic and available as oral - more prone
for misuse in VRSA / VRE.
Dr Md Ashraf Ali

39. 5. Daptomycin:
– Moreover for VRSA and VRE but still not a
major cause of concern
6. Tigecycline:
– Bacteriostatic, one of the most Broad spectrum
drugs, has limited role in MDR infections
7. Sulbactam alone:
– Reserved for PDR Acinetobacter.
Dr Md Ashraf Ali

40. Policy for Prophylaxis
• These antibiotics are given for short duration, free of side
effects and inexpensive.
• Not intended towards therapy.
Example
• Pre-op Kanamycin, neomycin oral antibiotics
• The addition of perioperative gentamicin and clindamycin
following oral antibiotic bowel preparation.
Dr Md Ashraf Ali

41. CONTRIBUTION FROM
MICROBIOLOGY LABORATORY
Dr Md Ashraf Ali

42. Samples:
• Physicians need to be advised on proper collection and
transport of the most appropriate specimen.
• Microbiological samples always be sent prior to
initiating antimicrobial therapy.
• Gram stain report, can help determine therapeutic
choices when empiric therapy is required.
• When resources are scarce, priority given to samples
from nosocomial, life threatening cases or sent to
referral hospital. Dr Md Ashraf Ali

43. • Reports of AST based on the drugs available in agreed
formulary.
• Doubtful pathogen isolated, susceptibility need not be
reported.
• Limited no. of antibiotics are selected to optimize patient
care, cost effectiveness, encourage better prescription.
E.g. Augmentin need not be reported if the organism is
sensitive to ampicillin/amoxicillin
Reports
Dr Md Ashraf Ali

44. Basic infrastructure should be updated for detection of
• MRSA
• ESBL producers.
Dr Md Ashraf Ali

45. Reports on drug
resistance
• Assess trends in development of
antimicrobial resistance
• Report should also indicate wherever organisms are
invariably resistant
e.g. MRSA are resistant to all beta-lactams
• Send regular updates /alerts to Hospital Antibiotic
committee, on emergence of resistance to antibiotics
used in hospital.
Dr Md Ashraf Ali

46. Notifications and documentation
• Microbiology labs should issue Hospital Antibiogram
at pre-defined intervals.
• Notification of communicable diseases.
• Multidrug-resistant bacteria, esp. pan-drug resistant
bacteria, must be considered as a notifiable entity..
Dr Md Ashraf Ali

47. Hospital Antibiogram:
Periodic summary of antimicrobial
susceptibilities of local bacteria isolates
submitted by the hospital’s clinical
microbiology laboratory.
Dr Md Ashraf Ali

48. Documentation of all
• Opportunistic infections
• Hospital infection outbreaks
• Emerging infections
Dr Md Ashraf Ali

49. Education
• Formal meeting, clinical
rounds, formal lectures
• Focus on new antibiotics,
route of administration
Surveillance
• Antibiotic resistance
• Antibiotic usage
DDD (defined daily dose)
• Prescription auditing
Dr Md Ashraf Ali

50. WHONET
Dr Md Ashraf Ali

51. What is WHONET
• WHONET is a free software developed by the WHO
Collaborating Centre for Surveillance of Antimicrobial
Resistance.
• Uses
 laboratory-based surveillance of infectious diseases
 antimicrobial resistance.
Dr Md Ashraf Ali

52. The principal goals of the software are:
1. to enhance local use of laboratory data;
2. to promote national and international collaboration through
the exchange of data.

53. Advantages
• The understanding of the local
epidemiology of microbial
populations;
• the selection of antimicrobial
agents;
• the identification of hospital and
community outbreaks
• the recognition of quality
assurance problems in laboratory
testing.
Dr Md Ashraf Ali

54. How it works..??
• The heart of WHONET is a
software package designed to
collect the results of
antibiotic resistance tests.
• Researchers / Microbiologists
feed the results into a
computer and look for trends.
Dr Md Ashraf Ali

55. Implementation of WHONET CAN HELP
TO MONITOR RESISTANCE
Dr Md Ashraf Ali

56. MONITORING TREATMENT
Dr Md Ashraf Ali

57. • The need for antimicrobial therapy should be reviewed daily.
• For most types of infection treatment should continue until
the clinical signs and symptoms of infection have resolved.
• Where treatment is apparently failing, advise from the
microbiologist, pharmacologist and ID Physician should
normally be sought rather than blindly changing to an
alternative choice of antimicrobial agent.
Dr Md Ashraf Ali

58. ROLE OF MEDICAL COUNCIL
OF INDIA
Dr Md Ashraf Ali

59. • One of the main reasons for the inappropriate antibiotic
usage by Indian doctors is the lack of adequate
training on the subject during undergraduate courses.
• This deficit in the basic training can only be overcome
if there is a change in the curriculum.
• Prescriptions from RMP, Quacks, AYUSH doctors
should be discouraged.
Dr Md Ashraf Ali

60. Curriculum change
• Structured training in antibiotic usage and infection
control should be introduced in curriculum.
• Infectious Diseases training in UG and PG
curriculum in all specialties.
Dr Md Ashraf Ali

61. Role of clinicians- Good practices
• Send for the appropriate investigations, the minimum
required for diagnosis of these infections.
• All antibiotic initiations - after sending appropriate
cultures
• Follow the Hospital policy when choosing antimicrobial
therapy. If alternatives chosen, document the reason in
case sheets.
• Check for factors which will affect drug choice & dose
e.g., renal function, interactions, allergy.
Dr Md Ashraf Ali

62. • Check that the appropriate dose is prescribed.
If uncertain, contact Infectious disease committee, Pharmacy,
or check in the formulary.
• The need for antimicrobial therapy should be reviewed on a
daily basis.
• Empiric Therapy
Where delay in initiating therapy would be life
threatening. antimicrobial therapy based on a clinically
defined infection is justified.
• Once culture reports are available, step down to the narrowest
spectrum.
Dr Md Ashraf Ali

63. Antimicrobial Cycling or Rotation:
Deliberate, scheduled removal and replacement of
specific antimicrobials with in institutional environment
to avoid the antimicrobial resistance.
Dr Md Ashraf Ali

64. Research works:
• Antimicrobial peptides(AMPs), Antimicrobial
lipopeptides (AMLPs)  target bacterial membranes,
making it nearly impossible to develop resistance
• Phage therapy
• Use of the lytic enzymes : in mucus and saliva
• But they are a long way off, as the researches
still in its infancy
Dr Md Ashraf Ali

65. A WORLD WITHOUT
ANTIBIOTICS- JUST IMAGINE
• A world without effective antibiotics is a terrifying
but real prospect. Overuse of antibiotics has led to
dangerous outbreaks of drug resistant disease, and
puts us in very real danger of a global pandemic. In
future we have to use ???
Dr Md Ashraf Ali

66. • India needs “An implementable antibiotic policy” and
NOT “A perfect policy”
• Asking for a strict antibiotic policy in a country where
there is currently no functioning antibiotic policy at all
may not be an intelligent or immediately viable option
without the political will to make such a drastic change.

67. SUMMARY

68. • Stop over the counter sale of drugs without prescription
• Hospital antibiotic committee should be formed in every hospital,
to draft an Antibiotic policy in hospitals.
• Strict adherence to antibiotic policy- part of infection control
• Microbiology labs- upgraded to detect MDR bacterias.
• Encourage good practices among clinicians.
• Implementation of “WHONET” for laboratory-based
surveillance of infectious diseases and antimicrobial resistance.
• Long term plans -MCI has a role.
• 2011 WHO slogan on antibiotic resistance
“no action today, no cure tomorrow”.

69. CONCLUSION

70. Microbiologist
Bacterial sensitivity
test and find out the
Possible cause of
development
Clinician
Treat infection

71. Sharing of expertise
Microbiologist
Bacterial sensitivity
test and find out the
Possible cause of
development
Physician
Treat infection
Antibiotic
committee
India needs “An implementable antibiotic policy” and NOT
“A perfect policy”.

72. References
• Infection control: Basic concepts and practices, 2nd edn.
• www.cdc.org
• Antibiotics guide: choices for common infections
• International Clinical Practice Guidelines for the
treatment of urinary tract infections : An Update
• Oxford handbook of infectious diseases

73. THANK
YOU
Dr Md. Ashraf Ali S N
PG in Microbiology
KIMS, Hubli