1.
Antibiotic Policy
Why We Need It ?
Dr.T.V.Rao MD
14-06-2013 Dr.T.V.Rao MD 1

2.
World has Changed with
14-06-2013 Dr.T.V.Rao MD 2

3.
Why take antibiotics?
William Osler, MD (1849 - 1919)
• "The desire to take
medicine is perhaps
the greatest feature
which distinguishes
man from animals."
• "One of the first duties
of the physician is to
educate the masses
not to take medicine"
H. Cushing, Life of Sir William Osler (1925)

4.
Fleming Nobel Prize Speech
identifies
• In his Nobel Prize
acceptance speech,
Fleming identified the risk
of bacteria becoming
resistant to antibiotics. If
a bacterium carries
several resistance genes,
it is called multiresistant
or, informally, a
"superbug."
14-06-2013 Dr.T.V.Rao MD 4

5.
1920 1930 1940 1950 1960 1970 1980 1990 2000
ertapenem
tigecyclin
daptomicin
linezolid
telithromicin
quinup./dalfop.
cefepime
ciprofloxacin
aztreonam
norfloxacin
imipenem
cefotaxime
clavulanic ac.
cefuroxime
gentamicin
cefalotina
nalidíxico ac.
ampicillin
methicilin
vancomicin
rifampin
chlortetracyclin
streptomycin
pencillin G
prontosil
The development
of anti-infectives …
Development of anti-microbials
Dr.T.V.Rao MD 514-06-2013

6.
• 50 penicillin's
• 71 cephalosporins
• 12 tetracycline's
• 8 aminoglycosides
• 1 monobactam
• 5 Carbapenems
• 9 macrolides
• 2 streptogramins
• 3 dihydrofolate
reductase
inhibitors
• 1 oxazolidinone
• 5.5 quinolones
Antibiotic brands
14-06-2013 Dr.T.V.Rao MD 6

7.
A Changing Landscape for
Numbers of Approved Antibacterial Agents
Bars represent number of new antimicrobial agents approved by the FDA during the period listed.
0
0
2
4
6
8
10
12
14
16
18
Numberofagentsapproved
1983-87 1988-92 1993-97 1998-02 2003-05 2008
Infectious Diseases Society of America. Bad Bugs, No Drugs. July 2004; Spellberg B et al. Clin Infect Dis. 2004;38:1279-1286;
New antimicrobial agents. Antimicrob Agents Chemother. 2006;50:1912
Resistance
14-06-2013 Dr.T.V.Rao MD 7

8.
14-06-2013 Dr.T.V.Rao MD 8

9.
Chronology of Development of
Antibiotic Resistance
Antibiotic Year introduced Resistance identified
Penicillin 1942 1940
Streptomycin 1947 1947
Tetracycline 1952 1956
Erythromycin 1955 1956
Gentamicin 1967 1970
Vancomycin 1956 1987
14-06-2013 Dr.T.V.Rao MD 9

10.
Scarcity of New Antibiotics
14-06-2013 Dr.T.V.Rao MD 10

11.
What went wrong with
Antibiotic Usage
• Treating trivial infections / viral
Infections with Antibiotics has
become routine affair.
• Many use Antibiotics without
knowing the Basic principles of
Antibiotic therapy.
• Many Medical practioners are
under pressure for short term
solutions. Dr.T.V.Rao MD 1114-06-2013

12.
Pharmaceutical industry
Pushes
• Commercial interests
of Pharmaceutical
industry pushing the
Antibiotics, more so
Broad spectrum and
Newer Generation
antibiotics. as every
Industry has become
profit oriented
14-06-2013 Dr.T.V.Rao MD 12

13.
Poverty and Drug Resistance
• Poverty
encourages drug
resistance due
to under
utilization of
appropriate
Antibiotics.
14-06-2013 Dr.T.V.Rao MD 13

14.
ANTIMICROBIAL RESISTANCE:
The role of animal feed antibiotic additives
• 48% of all antibiotics by weight is added to
animal feeds to promote growth. Results in
low, sub therapeutic levels which are
thought to promote resistance.
• Farm families who own chickens feed
tetracycline have an increased incidence of
tetracycline resistant fecal flora
14-06-2013 Dr.T.V.Rao MD 14

15.
Antibiotics
• Biology and Society
About 50% of the antibiotics produced
today are used in the livestock industry.
What impact does this have on the
treatment of human diseases?
14-06-2013 Dr.T.V.Rao MD 15

16.
Inappropriate use of antibiotics
is a worldwide problem
• More than 50% of all medicines are
prescribed, dispensed or sold inappropriately,
and half of all patients fail to take
medicines correctly.
• The overuse, underuse or misuse of medicines
harms people and wastes resources.
• More than 50% of all countries do not
implement basic policies to promote rational
use of medicines.
14-06-2013 Dr.T.V.Rao MD 16

17.
Chemists real threat
Soaring sales of antibiotics at Indian
pharmacies are compounding drug-resistance
problems
14-06-2013 Dr.T.V.Rao MD 17

18.
Carbapenems a real threat
Source ; Nature ( International Journal of Science)
14-06-2013 Dr.T.V.Rao MD 18

19.
Contribute for Creating Drug
Resistance
• Every time a person
takes antibiotics,
sensitive bacteria are
killed, but resistant
microbes may be left to
grow and multiply.
Repeated and improper
uses of antibiotics are
primary causes of the
increase in drug-
resistant bacteria.
Dr.T.V.Rao MD 1914-06-2013

20.
Creation of SUPERBUGS
• Antimicrobial resistance is a serious
global challenge. Every continent and
country faces the menace of antibiotic
resistant “super bugs,” though the extent
and the severity of the problem varies.
There could be a return to the
pre-antibiotic era, where many people
could suffer or die from untreatable
bacterial infections14-06-2013 Dr.T.V.Rao MD 20

21.
Hospital
 Intensive care
units
 Oncology units
 Dialysis units
 Rehab units
 Transplant units
 Burn units
Settings that Foster Drug Resistance
14-06-2013 Dr.T.V.Rao MD 21

22.
Treated without Coordination
• When the patients
to be treated by
several specialists,
multiple
antibiotics
prescribed,
• Drug Antagonism
14-06-2013 Dr.T.V.Rao MD 22

23.
The Nature Magazine
• At the Tata Memorial Centre in Mumbai,
where the oncologist treat, at least half of
bacterial samples (50%) from patients with
infections are resistant to Carbapenems — a
class of ‘second-line’ antibiotics used to treat
infections that are already resistant to other
Cephalosporin group of drugs. Just a few years
ago, the resistance rate in such samples was
only 30%
14-06-2013 Dr.T.V.Rao MD 23

24.
New Delhi metallo-beta-lactamase 1
India’s Famous Superbug
• New Delhi Metallo-
beta-lactamase (NDM-
1) is a gene that makes
bacteria resistant to
antibiotics of the
Carbapenems family. It
encodes a type of beta-
lactamase enzyme
called a
carbapenemases
14-06-2013 Dr.T.V.Rao MD 24

25.
Why inappropriate
use of antibiotics
contributes to
antibiotic resistance
– the “why”
Dr.T.V.Rao MD 2514-06-2013

26.
Our Indian Hospitals
• Indian hospitals have reported
very high Gram-negative
resistance rates, with very high
prevalence of ESBL (Extended
Spectrum Beta Lactamases)
producers and also high
carbapenem resistance rates.
14-06-2013 Dr.T.V.Rao MD 26

27.
Pan Drug Resistant Infections
• Increasing carbapenem resistance
will invariably result in increased
usage of colistin, currently the
last line of defence, with a
potential for colistin-resistant and
Pan Drug Resistant bacterial
infections
14-06-2013 Dr.T.V.Rao MD 27

28.
NABH DATA on Indian Hospitals
• As per data available
from NABH assessors
conclave most
accredited hospitals,
though having a well
written antibiotic
policy on paper, are
not compliant in
practice.
14-06-2013 Dr.T.V.Rao MD 28

29.
Can we tackle the Problem
• India, with more than
20,000 hospitals, more
than a billion population,
wide cultural diversity,
socio-economic disparity,
and a large medical
community of more than
three-fourths of a million
doctors, will find the
resistance problem an
issue very difficult to
tackle
14-06-2013 Dr.T.V.Rao MD 29

30.
Hospital Infection Control
Committee (HICC)
• All hospitals must have an infection control
committee and an antibiotic policy and should
initiate or augment efforts towards implementation.
• Those hospitals with an existing ICC and an antibiotic
policy should augment efforts to increase compliance
to the policy. Hospitals without a policy must
initiate efforts to formulate an ICC and an antibiotic
policy.
• ICC should define an annual target for achievement.
14-06-2013 Dr.T.V.Rao MD 30

31.
An antibiotic policy will:
• Improve patient care by promoting the best
practice in antibiotic prophylaxis and therapy,
• Make better use of resources by using cheaper
drugs where possible
• Retard the emergence and spread of multiple
antibiotic-resistant bacteria.
• *Improve education of junior doctors by
providing guidelines for appropriate therapy
• Eliminate the use of unnecessary or ineffective
antibiotics and restrict the use of expensive or
unnecessarily powerful ones
14-06-2013 Dr.T.V.Rao MD 31

32.
The following key persons should
be included in the committee:
• The Pharmacist who will report back
to the Antibiotic Committee at each
meeting on drug utilisation and cost.
• The Microbiologist who will report on
antibiotic susceptibility patterns of
bacteria isolated from major infections.
14-06-2013 Dr.T.V.Rao MD 32

33.
Important Participants
• Clinical doctors and nurses responsible for
direct patient care who provide a link between
clinical practice and the Antibiotic Committee.
• Manger(s) who will ensure the
resources are available for
implementation of the antibiotic policy.
• Reciprocal Membership between the Infection
Control Committee and the Drugs Committee
should be ensured.
14-06-2013 Dr.T.V.Rao MD 33

34.
In-patients are at high risk of antibiotic-
resistant infections
• Misuse of antibiotics in hospitals is one of the
main factors that drive development of
antibiotic resistance.
• Patients in hospitals have a high probability of
receiving an antibioticand 50% [adapt to
national figure where available] of all
antibiotic use in hospitals can be
inappropriate.
Dr.T.V.Rao MD 3414-06-2013

35.
Misuse of Antibiotics Drives
Antibiotic Resistance
• Studies prove that misuse of antibiotics may
cause patients to become colonized or
infected with antibiotic-resistant bacteria,
such as methicillin-resistant Staphylococcus
aureus (MRSA), vancomycin-resistant
enterococci (VRE) and highly-resistant Gram-
negative bacilli.
• Misuse of antibiotics is also associated with an
increased incidence of Clostridium difficle
infections. Dr.T.V.Rao MD 3514-06-2013

36.
Why we Need Antibiotic
Policy
Dr.T.V.Rao MD 3614-06-2013

37.
We are Under
Scanner for many reasons
14-06-2013 Dr.T.V.Rao MD 37

38.
Aim of Antibiotic Policy
• Reduce the Antimicrobial resistance
• Initiate best efforts in the hospital area
as many resistance Bacteria are
generated in Hospital areas and in
particular critical care areas.
• Initiate good hygienic practices so
these bacteria do not spread to
others
• Practice best efforts, these
resistance strains do not spill into
critically ill patients in the Hospital
Dr.T.V.Rao MD 3814-06-2013

39.
Objectives of Antibiotic Policy.
• Antibiotics should not be used casually
• Policy emphasizes, avoiding the use of
powerful Antibiotics in the Initial
treatments.
• We should create awareness that we are
sparing the powerful Broad spectrum
Drugs for later treatment
Patient saves Money
Doctors save Lives.
Dr.T.V.Rao MD 3914-06-2013

40.
Aims of the Antibiotic Policy
• Create awareness on Antibiotics as misuse is
counterproductive.
• More effective treatments in serious Infections.
• Reduce Health care associated infections spilling
to society and increase of Community associated
Infections.
( A growing concern in Developing world )
Dr.T.V.Rao MD 4014-06-2013

41.
Policy Deals on Broad Basis
• Clinicians /
Microbiologists /
Pharmacists and Nurses
do take part.
• Policies are framed on
demands of the Clinical
areas, depending on
recent Infection
surveillance data
contributed from
Microbiology
Departments.
Dr.T.V.Rao MD 4114-06-2013

42.
The 3 Stratagecies
Will it Work ?
• Complete ban on OTC sale of antibiotics without
prescription throughout the country.
• Complete ban of OTC sale of antibiotics without
prescription in metros and larger cities with a
more liberal approach in smaller cities and
villages.
• A liberal approach throughout the country to
start with, with an initial list of antibiotics under
restriction and addition of other drugs to the list
in a phased manner.
14-06-2013 Dr.T.V.Rao MD 42

43.
Education On Antibiotic policy
• Acton plan for Education to all concerned clinical staff
on Antibiotic prescriptions.
• Evaluate the feed back of success and failures of the
policy.
• Create Infection surveillance Data
• Developing facilities in Microbiology departments for
auditing data and guidance
• Restrictions in prescribing and Antibiotic availability.
• A continuous education to Junior Doctors
Dr.T.V.Rao MD 4314-06-2013

44.
Ideal Sample Collection is Essential
Requirement
• Proper specimen collection is combined
responsibility of Clinical and Microbiological
Departments.
• Continuous training of junior staff on sample
collection, and is most neglected necessity
• A good clinical history is greatly helpful in
differentiating community acquired infections
from hospital acquired infections.
Dr.T.V.Rao MD 4414-06-2013

45.
Strategies to Address Antimicrobial
Resistance (STAAR) Act
• “It is critical that Congress protect its
investment in the development of new
antimicrobials by enacting the STAAR Act,
which will strengthen the federal
response to antimicrobial resistance
through enhanced leadership,
surveillance, research, and data
collection
14-06-2013 Dr.T.V.Rao MD 45

46.
Role of Microbiology Departments
• Microbiology labs should issue hospital
Antibiogram at pre-defined intervals. Those
hospitals without good laboratory support should
be willing to outsource samples to better
laboratories. The system of notification of
communicable diseases is a popular,
established, though not strictly followed system
in the country. Multidrug-resistant bacteria,
especially pan-drug resistant bacteria, must be
considered as a notifiable entity. Such a reporting
system should complementnational antimicrobial
resistance surveillance studies.
14-06-2013 Dr.T.V.Rao MD 46

47.
India needs “An implementable antibiotic policy” and
NOT “A perfect policy”
• However, asking for a complete and 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. A multidisciplinary
committee of eminent experts should explore
the options available to us. For example,
should
14-06-2013 Dr.T.V.Rao MD 47

48.
• Antibiotics were
prescribed in 68% of
acute respiratory tract
visits – and of those, 80%
were unnecessary
according to CDC
guidelines
• Children are of particular
concern because they
have the highest rates of
antibiotic use.
Antibiotic Prescribing
Children real Concern
14-06-2013 Dr.T.V.Rao MD 48

49.
Rationalism in Implementation
Many choices ?
• Introduce step- by-
step regulation of
antibiotic usage,
concentrating on
higher end
antibiotics first and
then slowly
extending the list to
second and first line
antibiotics?14-06-2013 Dr.T.V.Rao MD 49

50.
Monitoring on Colistin
• Strict monitoring on the usage of colistin,
currently the most precious antibiotic in
an era of increasing carbapenem resistance,
must be implemented on an urgent basis.
Colistin prescription should be induplicate,
with a copy to be sent to the pharmacy. The
prescription must be countersigned by a
consultant in 24 hours.
14-06-2013 Dr.T.V.Rao MD 50

51.
Role of Microbiology Departments
• Microbiology labs should issue hospital
Antibiogram at pre-defined intervals. Those
hospitals without good laboratory support should
be willing to outsource samples to better
laboratories Multidrug-resistant bacteria,
especially pan-drug resistant bacteria, must be
considered as a notifiable entity. Such a reporting
system should complement national
antimicrobial resistance surveillance studies.
14-06-2013 Dr.T.V.Rao MD 51

52.
Better services from Microbiology
Departments.
• Basic infrastructure
should be updated for
detection of MRSA
and ESBL producers.
• Documentation of all
Opportunistic
infections. and
Hospital infection
outbreaks
Dr.T.V.Rao MD 5214-06-2013

53.
Carbapenemases
• Ability to hydrolyze penicillins,cephalosporins,
monobactams, and carbapenems
• Resilient against inhibition by all commercially viable ß-
lactamase inhibitors
– Subgroup 2df: OXA (23 and 48) carbapenemases
– Subgroup 2f : serine carbapenemases from molecular class
A: GES and KPC
– Subgroup 3b contains a smaller group of MBLs that
preferentially hydrolyze carbapenems
• IMP and VIM enzymes that have appeared globally, most
frequently in non-fermentative bacteria but also in
Enterobacteriaceae
14-06-2013 Dr.T.V.Rao MD 53

54.
Notifying Pan Resistant Microbes
Superbugs
• Pan-drug-resistant
Gram-negatives,
carbapenem-
resistant Gram-
Negatives,
Vancomycin-
resistant
Enterococcus and
MRSA should be
made notifiable14-06-2013 Dr.T.V.Rao MD 54

55.
MDR TB a Threat to Everyone
14-06-2013 Dr.T.V.Rao MD 55

56.
Bedaquiline
• Bedaquilin was the first TB drug to be
discovered in more than 40 years, and the first
one specifically for multi-drug resistant TB (MDR-
TB). MDR-TB arises when the M. tuberculosis
bacteria become resistant to two commonly used
first-line TB drugs — isoniazid and rifampicin.
• But less than six months after FDA approved the
drug under its accelerated approval programme,
is the drug a potential candidate for misuse by
doctors in India? Will it in any way result in
patients developing drug resistance?
14-06-2013 Dr.T.V.Rao MD 56

57.
Role of Medical Council of India
• One of the main reasons for the
inappropriate antibiotic usage by
Indian doctors is the lack of
adequate training on the subject
during undergraduate and post-
graduate courses. This deficit in the
basic training can only be overcome
if there is a change in the curriculum.14-06-2013 Dr.T.V.Rao MD 57

58.
Curriculum change
• Structured training in antibiotic usage and
infection control should be introduced in both
UG and PG curriculum.
• Infectious Diseases training in UG and PG
curriculum in all specialties.
• Antibiotic stewardship and infection
control one week rotation-3rd, 4th, and
final year MBBS.
14-06-2013 Dr.T.V.Rao MD 58

59.
WHONET
Documentation
Why We Need It
14-06-2013 Dr.T.V.Rao MD 59

60.
What is WHONET
Dr.T.V.Rao MD 60
• WHONET is a free software developed by the
WHO Collaborating Centre for Surveillance of
Antimicrobial Resistance for laboratory-based
surveillance of infectious diseases and antimicrobial
resistance.
• The principal goals of the software are:
• 1 to enhance local use of laboratory data; and
• 2 to promote national and international
collaboration through the exchange of data.
14-06-2013

61.
• The understanding of
the local epidemiology
of microbial
populations; the
selection of
antimicrobial agents;
the identification of
hospital and community
outbreaks; and the
recognition of quality
assurance problems in
laboratory testing.
Whonet helps us in ……
Dr.T.V.Rao MD 6114-06-2013

62.
All the Documented results are analyzed
in WHONET
• 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.T.V.Rao MD 6214-06-2013

63.
Clinicians can access data of their patients anytime in
the computer just with click of the mouse
Dr.T.V.Rao MD 6314-06-2013

64.
• Legacy computer systems,
quality improvement teams,
and strategies for
optimizing antibiotic use
have the potential to
stabilize resistance and
reduce costs by encouraging
heterogeneous prescribing
patterns and use of local
susceptibility patterns to
inform empiric treatment.
Implementation of WHONET CAN HELP TO
MONITOR RESISTANCE
Dr.T.V.Rao MD 6414-06-2013

65.
No Private Firms Investing in New
Antibiotics
• Drug makers have poured huge
sums into applying genomics and
proteomics to the problem. It has
not worked. Despite the millions
spent,, in a paper in Nature a few
years ago, his firm and others came
up empty-handed: “
14-06-2013 Dr.T.V.Rao MD 65

66.
Thirteen national science academies call
on G8 to act on drug resistance threat
A more responsible approach to drug prescription for
human use
Reduced use of antibiotics and other drugs in animal
husbandry
Incentives for pharmaceutical companies to develop
new drugs to fight infectious disease, especially new
antibiotics
Information and education programmes
A global system of control to combat the spread of
resistant microorganisms
14-06-2013 Dr.T.V.Rao MD 66

67.
Physicians Can Impact
Other clinicians
Patients
Optimize patient evaluation
Adopt judicious antibiotic
prescribing practices
Immunize patients
Optimize consultations with
other clinicians
Use infection control measures
Educate others about
judicious use of antibiotics14-06-2013 Dr.T.V.Rao MD 67

68.
Best way to keep the matters in Order
Every Hospital should have a policy which
is practicable to their circumstances.
The *Seniors physician in the respective
departments will make the best policy
Rigid guidelines without coordination
will lead to greater failures
The only way to keep Antimicrobial
agents useful is to use them appropriately and
Judiciously
(Burke A.Cunha, MD,MACP Antimicrobial Therapy. Medical Clinics of
North America NOV 2006)
Dr.T.V.Rao MD 6814-06-2013

69.
Who is A *Senior Physicians
• The young physician
starts life with 20
drugs for each
disease, and the
old(Senior )
physician ends life
with one drug for 20
diseases.
• William Osler
14-06-2013 Dr.T.V.Rao MD 69

70.
Our minimal Targets
• List of available antibiotics agreed by all
clinicians, indicating dosages, routes of
administration and toxicities.
Guidelines for therapy and prophylaxis.
• A regimen selection algorithm also might be
included in an antibiotic policy.
• CLSI guidelines are already followed
14-06-2013 Dr.T.V.Rao MD 70

71.
IMAGINE A WORLD WITHOUT
ANTIBIOTICS
• 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 ???
14-06-2013 Dr.T.V.Rao MD 71

72.
Conclusions
 Antibiotic resistance is a major
problem world-wide
 Resistance is inevitable with use
 Penicillin attained resistance before it is
used
 No new class of antibiotic introduced
over the last two decades
 Appropriate use is the only way of
prolonging the useful life of an antibiotic14-06-2013 Dr.T.V.Rao MD 72

73.
References
• The Chennai Declaration "Recommendations
of “A roadmap- to tackle the challenge of
antimicrobial resistance” – A joint meeting of
medical societies of India Ghafur etal, Indian
Journal of Cancer | October–December 2012 |
Volume 49 | Issue 4
• CDC, Atlanta USA Emerging Infectious
Diseases
• WHO guidelines on Antibiotic use
14-06-2013 Dr.T.V.Rao MD 73

74.
14-06-2013 Dr.T.V.Rao MD 74