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Rational use of
antibiotics &
antibiotic policy
By –
Dr. Vikas S. Sharma
Dept. Of Pharmacology
GMC, Nagpur
1 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Overview
i. Introduction
ii. Antimicrobial resistance & Antimicrobial resistance cycle
iii. Rational use of drugs
iv. Irrational use of antimicrobial
v. General principles in use of antibiotics
vi. The Council for Appropriate & Rational Antibiotic
Therapy (CARAT)
vii. Promoting rational prescription
viii.National antibiotic policy
ix. Antimicrobial stewardship
x. Summary
2 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
“Medicines are nothing in themselves,
if not properly used, but the very
hands of Gods, if employed with
reason and prudence.”
- Herophilus, Greek Physician
3 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
History of chemotherapy
• Chemotherapy:
• Pre-Ehrlich era: Before 1891
E.g. - Mouldy curd by Chinese in boils
Cinchona bark in malaria
Mercury in syphilis
Use of chemical compounds in treatment of
infectious diseases, so as to destroy
offending organisms & parasites without
damaging host tissues
4 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
• Period of Paul Ehrlich (1891-1935):
Dyes and organometallic compounds – “magic
bullets”
E.g. methylene blue for malaria
Arsenic for syphilis
• Period after 1935:
Discovery of sulfonamides and antibiotics
5 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Antibiotic Era
• Antibiotics - “miracle drugs” in 1940s
• Penicillin, wonder drug, saved millions of lives in
World war II & many mothers were saved from
puerperal sepsis
• Their widespread availability & success led to
dramatic reduction in morbidity & mortality
6 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Antibiotic Resistance
• As if proving the saying –
“What doesn’t kill you,
only makes you stronger”
Bacteria underwent a rapid unprecedented
evolution to circumvent this menace to their
survival
• WHO –
7 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Microorganism’s resistance to an antibiotic drug that
was once able to treat an infection by that
microorganism
Mechanism of resistance and its
transfer
1. Enzymatic alteration
2. Decreased permeability
3. Efflux
4. Alteration of target site
5. Protection of target site- Tetracycline, quinolones
6. Overproduction of target- Sulphonamides,
trimethoprim, glycopeptide
7. Bypass of inhibited process- Sulphonamides,
trimethoprim
8. Bind up antibiotic- Glycopeptide
β Lactams,
Aminoglycosides,
Macrolides,
Quinolones,
Chloramphenicol
8 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
9 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
What is Rational Use of Drugs?
10 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Requires that patients receive medicines
appropriate to their clinical needs, in doses
to meet individual requirements, for an
adequate period of time, at the lowest
cost to them & the community
– WHO (1985)
What is causing antimicrobial
resistance ?
• Irrational use –
• Irrational prescribing -
 Taking antibiotics without prescription
 Skipping doses of antibiotics
 Taking antibiotics at irregular intervals
 Saving antibiotics to use them later
 Unnecessary prescription of antibiotics
 Wrong selection of antibiotics
 Inappropriate dose or duration of antibiotics
11 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
What is causing antimicrobial
resistance ???
• Indiscrimate use of
Antibiotics in Animals
• R plasmids spread among co-
inhabiting bacterial flora in
animals ( in gut )
• R plasmids may be mainly
involved in animals spread to
human commensal - E. coli
followed by spread to more
important human pathogens
Eg Shigella spp.
12 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Irrational prescribing =
"pathological" prescribing
• Use of drugs when no drug therapy is indicated
• Use of wrong drug for specific condition
• Use of drugs with doubtful or unproven efficacy
• Use of drugs of uncertain safety status
• Failure to provide available, safe & effective drugs
• Use of correct drugs with incorrect administration,
dosages & duration
• Use of unnecessarily expensive drugs
13 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Examples of inappropriate
prescribing practices
• Overuse of antibiotics & antidiarrheals for nonspecific
childhood diarrhea
• Indiscriminate use of injections, e.g. in malaria treatment
• Multiple or over-prescription
• Excessive use of antibiotics for treating minor acute
respiratory tract infections
14 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Factors Underlying Irrational Use
of Drugs
• Patients:
 Drug misinformation
 Misleading beliefs
 Patient demands/expectations
 Marketing pressures
 Economic considerations
 Lack of access to proper health care
15 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Factors Underlying Irrational Use of Drugs...
• Prescribers:
 Lack of education and training
 Inappropriate role models
 Lack of objective drug information
 Generalization of limited experience
 Misleading beliefs about drugs efficacy
 Delayed lab results, fear of clinical failure
 Inappropriate peer norms
 Local medical culture
 Economic incentives
 Patient demand of “quick fix”
16 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Factors Underlying Irrational Use of Drugs...
• Workplace:
• Drug Supply System:
 Heavy patient load
 Pressure to prescribe
 Lack of adequate lab capacity
 Insufficient staffing
 Unreliable suppliers
 Drug shortages
 Expired drugs supplied
17 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Factors Underlying Irrational Use of Drugs...
• Drug Regulation:
• Industry:
 Nonessential drugs available
 Informal prescribers
 Lack of rational drug policy
 Lack of infrastructure
 Lack of regulation enforcement
 Promotional activities
 Misleading claims
18 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Consequences of irrational use
of antibiotics
• Reduction in quality of drug therapy - ↑ morbidity &
mortality
• Waste of resources - ↓ availability of other vital drugs & ↑
costs
• ↑ risk of unwanted effects - ADRs & emergence of
antimicrobial resistance
• Psychosocial impacts - “a pill for every ill” - apparent ↑
demand for drugs
• ↑ Treatment failures
19 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
General principles in use of antibiotics
• Appropriate Antibiotic Therapy:
1. Perception of need
Is an antibiotic necessary?
2. Choice of antibiotic
What is the most appropriate antibiotic?
3. Choice of regimen
What dose, route, frequency & duration are needed?
4. Monitoring efficacy
Is the treatment effective?
20 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
General principles
I. Host factors:
1. Age
– Some drugs are contraindicated in children like
tetracycline - discolor teeth
– Renal function and creatinine clearance ↓ elderly -
↓ doses
2. Renal and hepatic function:
– Aminoglycosides and glycopeptides - carefully even
in mild renal failure
– Macrolides, metronidazole, rifampicin & INH - doses
↓ in liver failure
21 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Host factors…
3. Pregnancy & lactation
– Aminoglycosides & tetracyclines should be avoided
– Penicillins, cephalosporins & erythromycin appear to
be safe
– Drugs like trimethoprim, metronidazole & macrolides
enter breast milk
4. Site of infection
– Antibiotics need to achieve sufficient local conc.
– Abscesses will require drainage, necrotic material to
be debrided
22 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Host factors…
5. Immune status
– AIDS, hematological malignancies; influence both
likelihood of infection & its likely etiology
6. Presence of prosthetic material
– Rarely respond to antibiotic therapy
– Usually require removal of device
7. Allergy
– Determination of previous allergic drug reactions
– Drug of choice for syphilis in patient allergic to
penicillin is tetracycline
23 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
II. Likely infecting agent:
 Clinical assessment may allow likely source of infection
 Empirical treatment is aimed at these organisms
 Bacteriological examination supports to establish definitive
microbiological diagnosis
(a) Bacteriological services are not available
(b) Bacteriological services are available, but treatment
cannot be delayed
(c) Bacteriological services are available & treatment can
be delayed for a few days
24 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
III. Drug related factors
1. Spectrum of activity:
For definitive therapy - narrow-spectrum drug
For empirical therapy - broad-spectrum drug
2. Type of activity:
Severe acute infections - cidal than a static drug
Bactericidal antibiotic - superior (impaired host defence,
life-threatening infections, infections at less accessible
sites or when carrier state is possible)
25 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Drug related factors...
3. Sensitivity of the organism:
Assessed on basis of MIC values & postantibiotic effect
4. Relative toxicity:
Less toxic antibiotic is preferred
e.g. β-lactam over aminoglycoside
5. Pharmacokinetic profile:
For optimum action antibiotic has to be present at site
of infection in sufficient conc. for adequate length of
time
26 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Drug related factors...
 For many organisms, aminoglycosides, fluoroquinolones &
metronidazole - ‘concentration-dependent inhibition’
 For many organisms, β-lactams, glycopeptides & macrolides
- ‘time-dependent inhibition’
 Penetration to site of infection - drug which penetrates
better & attains higher conc. at site of infection
6. Cost:
Less expensive drugs are to be preferred
27 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Drug related factors...
7. Routes of administration:
 Parenteral therapy:
• Seriously ill patient, where effective drug conc.
are required rapidly at site of infection
• Drugs not orally absorbed e.g. aminoglycosides
• Oral route is contraindicated
 Oral therapy
 Topical therapy
• Superficial skin infections, mucosal candidiasis,
middle ear & superficial ocular infections
28 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Drug related factors...
8. Dosage regimens:
– Dose influenced by severity of infection, age & weight
– Standard treatment guidelines should be followed
9. Encouraging compliance:
– Less frequency improves compliance
10. Length of treatment:
– Depends upon site & severity of infections, causative
organisms & patient’s response to treatment
29 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Combination therapy
• Objectives:
1. To achieve synergism:
Manifests in terms of ↓ in MIC of one antimicrobial
agents in presence of another or MICs of both may be ↓
• General guidelines:
(a) Two bacteriostatic agents are often additive, rarely
synergistic
(b) Two bactericidal drugs are frequently additive &
sometime synergistic if organism is sensitive to both
30 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Combination therapy…
(c) Combination of a bactericidal with bacteriostatic drug
may be synergistic or antagonistic depending on organism
 If organism is highly sensitive to cidal drug—response to
combination is equal to static drug given alone (apparent
antagonism)
 If organism has low sensitivity to cidal drug—synergism
31 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Combination therapy…
2. To reduce severity or incidence of adverse effects:
Possible only if combination is synergistic - doses can be ↓
3. To prevent emergence of resistance:
 Principle of using two or more antimicrobial agents
together is valid primarily for chronic infections needing
prolonged therapy
 If incidence of resistant mutants of bacillus infecting
individual for drug A is 105 and for drug B is 107, then only
one out of 1012 bacilli will be resistant to both
32 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Combination therapy…
4. To broaden spectrum of antimicrobial action
(a) Treatment of mixed infection - aerobic & anaerobic
organisms sensitive to different drugs are often
involved
(b) Initial treatment of severe infections - drugs
covering gram-positive and gram-negative (in certain
situations anaerobes as well)
(c) Topically - AMAs which are not used systemically,
are poorly absorbed from local site & cover broad
range of bacteria
33 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Disadvantages of combinations
• Foster casual rather than rational outlook in diagnosis of
infections & choice of antimicrobial agents
• ↑ incidence & variety of ADRs. Toxicity of one agent may
be enhanced by another
• ↑ chances of superinfections
• If inadequate doses of non-synergistic drugs are used—
emergence of resistance
• Higher cost of therapy
34 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
The Council for Appropriate and Rational
Antibiotic Therapy (CARAT)
• CARAT is independent, multidisciplinary panel
of healthcare professionals, clinicians as well
as scientists, established to advocate
appropriate & accurate use of antibiotics
35 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
CARAT criteria
 Evidence based results
 Therapeutic benefits
 Safety
 Cost-Effectiveness
 Optimal drug dose and duration
36 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Evidence based results
• In choosing an antibiotic, clinicians should consider
clinical evidence –
 Drug is clinically and microbiologically appropriate
 Efficacy of drug in well-designed clinical trials
 Antibiotic resistance pattern of local region
• Well conducted, randomized, controlled clinical trials
provide highest quality information for making
decisions
37 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Therapeutic Benefits
• Key to applying evidence-based results & making
appropriate therapeutic choices for each patient
involves determining correct diagnosis & analyzing
therapeutic benefits of possible treatments
• To maximize patient health & reduce unnecessary
prescribing, therapeutic benefits of each drug should
be considered relative to status of patient’s infection
38 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Therapeutic Benefits…
• Clinician must consider any evidence that particular
antibiotic can result in clinical & microbiologic cure as
well as treatment failures associated with absence of
drug treatment
• If possible, clinician should identify causative pathogen
& use surveillance data on regional antibiotic resistance
patterns in selecting optimal therapeutic agent
39 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Safety
• Clinically applicable treatment strategies should be chosen
to maximize efficacy while minimizing side effects
• In study, between 1975 and 2000, 548 new chemical
entities were approved for use in US; 45 of these (8.2%)
acquired new black-box warnings & 16 (2.9%) were
withdrawn from market during this time
• Of 16 withdrawn from market, 8 were withdrawn within
2 years after their introduction
• E.g. Temafloxacin was withdrawn 0.3 years after
introduction and grepafloxacin was withdrawn 2.0 years
after introduction
40 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Cost effectiveness
• Choosing inappropriate therapy is associated with
increased costs, including cost of antibiotic & increases
in overall costs of medical care
Due to treatment failures and adverse events
• Using optimal course of antibiotics can have economic
as well as clinical advantages
• Outpatients may experience faster return to their
normal daily routine & earlier return to work
41 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Optimal Drug for Optimal Duration
• Optimal drug selection requires finding antimicrobial class
& specific member of that class
• Because empiric therapy is used in most cases:
- Etiologic agent - gram +VE or gram –VE ?
- Narrow or broad-spectrum agent ?
- Resistance patterns of likely pathogen to this drug, both
nationally and regionally &
- Individual patient’s medical history, including
recent antibiotic exposure
42 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Optimal Drug for Optimal Duration…
• Optimal duration:
Prescribing selected drug for shortest amount of
time required for clinical & microbiologic efficacy
– Decreased side effects
– Increased patient adherence
– Decreased promotion of resistance
– Decreased cost
43 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
The pipeline is drying up!
US FDA approval of new
antibacterials down 56% from
1983 to 2002
 Infectious diseases are still
most common cause of death
worldwide
 We are effectively living in
post-antibiotic era
 Therefore, we must manage
carefully and responsibly what
we have
44 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Science magazine; July 18, 2008
The last decade has seen inexorable proliferation
of a host of antibiotic resistant bacteria, or bad
bugs, not just MRSA, but other insidious players
as well… For these bacteria, the pipeline of new
antibiotics is verging on empty. 'What do you do
when you're faced with an infection, with a very
sick patient, and you get a lab report back and
every single drug is listed as resistant?' asked
Dr. Fred Tenover, Centers for Disease Control
and Prevention (CDC). 'This is a major blooming
public health crisis.’
45 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Best way to keep the matters in order
• Nearly 50% of hospitalized patients receive
antimicrobial agents
• Every hospital should have a policy which is
practicable to their circumstances
• Rigid guidelines without coordination will lead to
greater failures
• Only way to keep antimicrobial agents useful is to
use them appropriately & judiciously
46 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
National Policy
• Government of India - National policy for containment of
antimicrobial resistance in 2011
• Aims & objectives:
1. Understanding emergence & spread of antimicrobial
resistance & the factors influencing it
2. Establish nationwide well coordinated antimicrobial
program with well defined & interlinked responsibilities
& functions of different arms of program
47 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
National policy for containment of antimicrobial
resistance in 2011...
3. Rationalizing usage of available antimicrobials
4. Reducing antibiotic selection pressures by appropriate
control measures
5. Promotion of discovery of newer & effective
antimicrobials based on current knowledge of
resistance mechanisms
6. Rapid and accurate diagnosis of infections &
infectious diseases
48 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Antibiotic policy
• A corporate document that is designed to
further the aim of the hospital to provide a
high standard of patient care
• Principles of antibiotic policy were laid down
in 1980s
49 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Antibiotic policy…
• Educational programs designed to improve antibiotic uses
• Controls operated through Pharmacy department
– Creation of hospital pharmacopeia
– Written justification for costlier & broader spectrum
antibiotics
– Introduction of concept of stop orders
– Automatic changes from IV to oral antibiotic therapy
– Sponsoring of antibiotics according to their usage e.g.
prophylaxis, specific therapy, therapeutic trials etc.
50 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Antibiotic policy…
• Controls through laboratory in form of reporting,
regular issue of resistance / susceptibility patterns &
active consultations
• Establishment of antibiotic advisory service in hospitals
• Publication of consensual antibiotic policy for special
use e.g. prophylaxis & specialized clinical units
• Audit of antibiotic usage; antibiotics as a class of drugs
accounts for largest expenditure in health care system
51 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Antibiotic policy…
• Promotion of ethical relationship between the
pharmaceutical companies, prescribers and pharmacists
• Regulation of antibiotic usage in veterinary practices. All
veterinary antibiotics should need prescription
• Monitoring of antibiotic residues in food of animal origin
• Encourage research to develop new molecules
Infectious Disease Society of America’s
“10 × ‘20 initiative”
52 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
What can we do ?
53 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Promoting rational prescribing
• Standard treatment guidelines - when evidence-
based, developed with end-users, with active
dissemination & follow-up
• Essential medicines lists - when linked to
treatment guidelines & used for training & supply
• Hospital Drugs & Therapeutic Committees
• Undergraduate training
• Comprehensive approach, with all components
54 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Possible interventions in private sector
• Regulation:
Market approval, re-licensing, re-evaluation per
therapeutic category, regulation of promotion, ban
over-the-counter (OTC) sale of antimicrobials
• Training:
Basic training, national clinical guidelines, CMEs
by universities & professional bodies, re-licensing
of professionals on basis of education points,
medical audit, patient information leaflets, public
education
55 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Possible interventions in private sector...
• Financial incentives:
Separate prescribing from dispensing,
dispensing fee (flat or tiered), price controls
on generic / brand drugs, contracting out
• Insurance:
Reimbursement limited to essential
medicines, reference pricing
56 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Educating Practitioners
• Seminars
• Panel discussion
• Updates
57 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Don’t let the advertisements block
our intelligence !!!
***Read the fine prints
 The drug is 10 times more potent
but may cause renal damage in some
 The most effective antibiotic
For what?
At what cost?
What duration?
58 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Educating Consumers
No self medication No own antibiotic kit Emphasis on dose
and duration
59 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Standard Treatment Guidelines
 A systematically developed statement to
assist practitioners in making decisions about
appropriate health care for specific clinical
conditions
 These guidelines should be tailored to local
situations and specific to levels of care
 From national level to hospital level
60 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Key features of standard
treatment guidelines
• Simplicity
• Credibility
• Same standard for all levels
• Drug supply based on standard treatment guidelines
• Introduce in pre-service training
• Dynamic (regular updates)
• Handy pocket books
61 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Increasing use of diagnostic tests
• Lack of adequate, well equipped laboratory facilities
• Under-utilization of microbiological labs
• Ministry of Health & Family Welfare recommends for
increase in utilization of diagnostic tests in clinical practice
• Newer rapid molecular diagnostic tests –
 Peptide nucleic acid technology
 Matrix-assisted laser desorption/ionization technology
 rapid polymerase chain reaction
62 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Surveillance
• Two complementary types of surveillance -
– Surveillance for antibiotic resistance
– Surveillance for antibiotic use
• Knowing resistance levels & tracking them over period of
time is powerful tool to support real changes
• Once link between resistance & antibiotic is accepted,
tracking antibiotic use can be used as surrogate for
changes in antibiotic resistance
63 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Surveillance…
 Sentinel surveillance for antimicrobial
resistance:
• Provides only indicative data, but the same can be
extrapolated to rest of population
• Suitable mode of surveillance when prolonged &
detailed data is needed
• Best approach for our country
64 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
WHONET Software
• Free Windows-based database software
• Developed for management & analysis of microbiology
laboratory data with special focus on analysis of
antimicrobial susceptibility test results
• Used by clinical, public health, veterinary & food
laboratories in over 90 countries to support local &
national surveillance programs
65 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Proposed care bundles for antibiotic
prescribing
• Acute care: initiation of therapy
 Document clinical rationale for antibiotic initiation
 Collect & send appropriate specimens to microbiology
laboratory
 Select antibiotic therapy according to local policies (i.e.,
local antimicrobial susceptibilities) & risk group (exclude
drug allergy)
 Consider removal of foreign body/drainage of
pus/surgical intervention
66 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Proposed care bundles for antibiotic
prescribing...
• Acute care: continuation of therapy
 On daily basis, consider de-escalation, parenteral-to-oral
conversion, or discontinuation of antibiotic therapy
based on clinical signs & symptoms and laboratory test
results
 Monitor serum antibiotic conc. in accordance with local
policies
67 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Proposed care bundles for antibiotic
prescribing...
• Surgical prophylaxis:
 Select antibiotic therapy based on local guidelines
(i.e., local antimicrobial susceptibilities) & type of
surgery (exclude drug allergy)
 Give first dose within guideline-defined time before
incision
 Discontinue antibiotic therapy within guideline defined
time after first preoperative dose or surgical end time
68 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Infection prevention & control methods for
controlling antimicrobial resistance in
hospitals
• Hand hygiene
• Contact (i.e. barrier) precautions
• Active surveillance for and decolonization (i.e.
eradication) of multidrug-resistant organisms
• Preoperative antimicrobial prophylaxis
69 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Infection prevention & control methods for controlling
antimicrobial resistance in hospitals...
• Implementation of best practices for invasive
procedures & devices (e.g., removal of
unnecessary central catheters)
• Disinfection & sterilization of medical devices
• Environmental cleaning
70 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Antimicrobial stewardship
• Definition –
The optimal selection, dosage & duration
of antimicrobial treatment that results in
the best clinical outcome for the
treatment or prevention of infection,
with minimal toxicity to the patient and
minimal impact on subsequent resistance
71 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Goals of antimicrobial stewardship
• To work with health care practitioners to help
each patient receive most appropriate
antimicrobial with correct dose and duration
• To prevent antimicrobial overuse, misuse & abuse
• To minimize development of resistance
• Reduction of health care costs without adversely
impacting quality of care
72 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Antibiotic stewardship team
Collaboration between antimicrobial stewardship team,
hospital infection control, pharmacy, therapeutics
committees & hospital administration is essential
 Infectious Disease Physician
 Clinical Pharmacist with infectious disease training
 Clinical Microbiologist
 Information system specialist
 Infection control professional
 Hospital epidemiologist (Optional)
73 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Antibiotic stewardship team…
• Functions-
– Providing high standard of patient care
– Improving rational utilization of antibiotic
– Pharmacovigilance of antimicrobial
– Effective utilization of financial resources in purchase
of antimicrobials
– Curbing emergence of microbial resistance
74 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
The Antibiotic Resistance
Declaration
• May 2014, Antibiotic Resistance Coalition -
‘Declaration on Antibiotic Resistance’ to advocate for
policy change & action to prevent post-antibiotic era
from becoming a bleak reality
• Chennai Declaration: December 2012
A document, prepared by representatives of
various stakeholders and eminent experts in India, to
tackle the challenge of anti-microbial resistance from
an Indian perspective
75 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Use of antibiotics wisely
- The only solution
• Before taking any antibiotic ask your physician if it is
required & beneficial
• Always take antibiotics as prescribed by physician
• Take antibiotics to treat only bacterial infections
• Don’t take antibiotics in viral infections such as cold,
cough or flu
• Don’t repeat same antibiotic for next time you get sick
76 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Use of antibiotics wisely - The only solution...
• Don’t stop antibiotic before complete prescribed
course of treatment
• Don’t skip doses
• Don’t copy antibiotic with same diseases which is
prescribed for someone else
• Educate yourself & talk to your physician about
antibiotic resistance
77 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
78 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
79 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
“The public will demand [the drug and] … then will begin
an era … of abuses. The microbes are educated to resist
penicillin and a host of penicillin-fast organisms is bred
out which can be passed to other individuals and perhaps
from there to others until they reach someone who gets
a septicemia or a pneumonia which penicillin cannot save.
In such a case the thoughtless person playing with
penicillin treatment is morally responsible for the death
of the man who finally succumbs to infection with the
penicillin-resistant organism. I hope the evil can be
averted.”
- Alexander Fleming, 1945
80 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Summary
• Infectious diseases are still serious problem,
compounded by development of antibiotic resistance
in many bacteria & relative lack of newer
antimicrobial agents to combat these multi-resistant
organisms
• Appropriate aggressive short-course treatment is
recommended for ensuring clinical & microbiologic
cure, optimal patient adherence & minimal generation
of antibiotic resistance
81 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
• Ideally, institution of 5 CARAT criterias will optimize
safe & well-tolerated treatment regimens, curb
unnecessary prescribing of antibiotics, decrease
treatment costs & increase adherence
• By making antimicrobial stewardship part
of our daily practice, we can improve patient safety &
care, reduce unnecessary use of valuable resources &
reduce resistance
• Thus, antibiotic prescribing should be prudent,
thoughtful & rational
82 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
References
• Goodman & Gilman’s The Pharmacological Basis of
Therapeutics 12th Edition
• R.S. SATOSKAR. PHARMACOLOGY AND
PHARMACOTHERAPEUTICS 24th EDITION
• Bertram G. Katzung & Anthony J. Trevor’s Basic & Clinical
Pharmacology 13th Edition
• National policy for containment of antimicrobial
resistance, India 2011.
1 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
References...
• Vance MA, Millington WR. Principles of irrational drug
therapy. Int J Health Serv. 2010;16(3):355–61.
• National Nosocomial Infections Surveillance (NNIS)
System Report, data summary from January 1992
through June 2003, issued August 2003. Am J Infect
Control. 2003;31(8):481-498
• Dellit TH, Owens RC, McGowan JE Jr, et al. IDSA and
SHEA guidelines for developing an institutional program
to enhance antimicrobial stewardship. Clin Infect Dis.
2007;44(2):159-177
Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
References...
• Gerding DN. The search for good antimicrobial
stewardship. Jt Comm J Qual Improv. 2001;27(8):403-
404
• Thomas G. Slama et al. A clinician’s guide to the
appropriate and accurate use of antibiotics: the Council
for Appropriate and Rational Antibiotic Therapy (CARAT)
criteria. doi:10.1016/j.amjmed.2005.05.007
• “Chennai Declaration” Team. “Chennai Declaration”: 5-year
plan to tackle the challenge of anti-microbial resistance.
IJMM, (2014) 32(3): 221-2281
Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
Thank you !!!
Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017

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Rational use of antibiotics & antibiotic policy

  • 1. Rational use of antibiotics & antibiotic policy By – Dr. Vikas S. Sharma Dept. Of Pharmacology GMC, Nagpur 1 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 2. Overview i. Introduction ii. Antimicrobial resistance & Antimicrobial resistance cycle iii. Rational use of drugs iv. Irrational use of antimicrobial v. General principles in use of antibiotics vi. The Council for Appropriate & Rational Antibiotic Therapy (CARAT) vii. Promoting rational prescription viii.National antibiotic policy ix. Antimicrobial stewardship x. Summary 2 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 3. “Medicines are nothing in themselves, if not properly used, but the very hands of Gods, if employed with reason and prudence.” - Herophilus, Greek Physician 3 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 4. History of chemotherapy • Chemotherapy: • Pre-Ehrlich era: Before 1891 E.g. - Mouldy curd by Chinese in boils Cinchona bark in malaria Mercury in syphilis Use of chemical compounds in treatment of infectious diseases, so as to destroy offending organisms & parasites without damaging host tissues 4 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 5. • Period of Paul Ehrlich (1891-1935): Dyes and organometallic compounds – “magic bullets” E.g. methylene blue for malaria Arsenic for syphilis • Period after 1935: Discovery of sulfonamides and antibiotics 5 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 6. Antibiotic Era • Antibiotics - “miracle drugs” in 1940s • Penicillin, wonder drug, saved millions of lives in World war II & many mothers were saved from puerperal sepsis • Their widespread availability & success led to dramatic reduction in morbidity & mortality 6 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 7. Antibiotic Resistance • As if proving the saying – “What doesn’t kill you, only makes you stronger” Bacteria underwent a rapid unprecedented evolution to circumvent this menace to their survival • WHO – 7 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017 Microorganism’s resistance to an antibiotic drug that was once able to treat an infection by that microorganism
  • 8. Mechanism of resistance and its transfer 1. Enzymatic alteration 2. Decreased permeability 3. Efflux 4. Alteration of target site 5. Protection of target site- Tetracycline, quinolones 6. Overproduction of target- Sulphonamides, trimethoprim, glycopeptide 7. Bypass of inhibited process- Sulphonamides, trimethoprim 8. Bind up antibiotic- Glycopeptide β Lactams, Aminoglycosides, Macrolides, Quinolones, Chloramphenicol 8 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 9. 9 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 10. What is Rational Use of Drugs? 10 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017 Requires that patients receive medicines appropriate to their clinical needs, in doses to meet individual requirements, for an adequate period of time, at the lowest cost to them & the community – WHO (1985)
  • 11. What is causing antimicrobial resistance ? • Irrational use – • Irrational prescribing -  Taking antibiotics without prescription  Skipping doses of antibiotics  Taking antibiotics at irregular intervals  Saving antibiotics to use them later  Unnecessary prescription of antibiotics  Wrong selection of antibiotics  Inappropriate dose or duration of antibiotics 11 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 12. What is causing antimicrobial resistance ??? • Indiscrimate use of Antibiotics in Animals • R plasmids spread among co- inhabiting bacterial flora in animals ( in gut ) • R plasmids may be mainly involved in animals spread to human commensal - E. coli followed by spread to more important human pathogens Eg Shigella spp. 12 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 13. Irrational prescribing = "pathological" prescribing • Use of drugs when no drug therapy is indicated • Use of wrong drug for specific condition • Use of drugs with doubtful or unproven efficacy • Use of drugs of uncertain safety status • Failure to provide available, safe & effective drugs • Use of correct drugs with incorrect administration, dosages & duration • Use of unnecessarily expensive drugs 13 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 14. Examples of inappropriate prescribing practices • Overuse of antibiotics & antidiarrheals for nonspecific childhood diarrhea • Indiscriminate use of injections, e.g. in malaria treatment • Multiple or over-prescription • Excessive use of antibiotics for treating minor acute respiratory tract infections 14 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 15. Factors Underlying Irrational Use of Drugs • Patients:  Drug misinformation  Misleading beliefs  Patient demands/expectations  Marketing pressures  Economic considerations  Lack of access to proper health care 15 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 16. Factors Underlying Irrational Use of Drugs... • Prescribers:  Lack of education and training  Inappropriate role models  Lack of objective drug information  Generalization of limited experience  Misleading beliefs about drugs efficacy  Delayed lab results, fear of clinical failure  Inappropriate peer norms  Local medical culture  Economic incentives  Patient demand of “quick fix” 16 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 17. Factors Underlying Irrational Use of Drugs... • Workplace: • Drug Supply System:  Heavy patient load  Pressure to prescribe  Lack of adequate lab capacity  Insufficient staffing  Unreliable suppliers  Drug shortages  Expired drugs supplied 17 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 18. Factors Underlying Irrational Use of Drugs... • Drug Regulation: • Industry:  Nonessential drugs available  Informal prescribers  Lack of rational drug policy  Lack of infrastructure  Lack of regulation enforcement  Promotional activities  Misleading claims 18 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 19. Consequences of irrational use of antibiotics • Reduction in quality of drug therapy - ↑ morbidity & mortality • Waste of resources - ↓ availability of other vital drugs & ↑ costs • ↑ risk of unwanted effects - ADRs & emergence of antimicrobial resistance • Psychosocial impacts - “a pill for every ill” - apparent ↑ demand for drugs • ↑ Treatment failures 19 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 20. General principles in use of antibiotics • Appropriate Antibiotic Therapy: 1. Perception of need Is an antibiotic necessary? 2. Choice of antibiotic What is the most appropriate antibiotic? 3. Choice of regimen What dose, route, frequency & duration are needed? 4. Monitoring efficacy Is the treatment effective? 20 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 21. General principles I. Host factors: 1. Age – Some drugs are contraindicated in children like tetracycline - discolor teeth – Renal function and creatinine clearance ↓ elderly - ↓ doses 2. Renal and hepatic function: – Aminoglycosides and glycopeptides - carefully even in mild renal failure – Macrolides, metronidazole, rifampicin & INH - doses ↓ in liver failure 21 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 22. Host factors… 3. Pregnancy & lactation – Aminoglycosides & tetracyclines should be avoided – Penicillins, cephalosporins & erythromycin appear to be safe – Drugs like trimethoprim, metronidazole & macrolides enter breast milk 4. Site of infection – Antibiotics need to achieve sufficient local conc. – Abscesses will require drainage, necrotic material to be debrided 22 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 23. Host factors… 5. Immune status – AIDS, hematological malignancies; influence both likelihood of infection & its likely etiology 6. Presence of prosthetic material – Rarely respond to antibiotic therapy – Usually require removal of device 7. Allergy – Determination of previous allergic drug reactions – Drug of choice for syphilis in patient allergic to penicillin is tetracycline 23 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 24. II. Likely infecting agent:  Clinical assessment may allow likely source of infection  Empirical treatment is aimed at these organisms  Bacteriological examination supports to establish definitive microbiological diagnosis (a) Bacteriological services are not available (b) Bacteriological services are available, but treatment cannot be delayed (c) Bacteriological services are available & treatment can be delayed for a few days 24 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 25. III. Drug related factors 1. Spectrum of activity: For definitive therapy - narrow-spectrum drug For empirical therapy - broad-spectrum drug 2. Type of activity: Severe acute infections - cidal than a static drug Bactericidal antibiotic - superior (impaired host defence, life-threatening infections, infections at less accessible sites or when carrier state is possible) 25 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 26. Drug related factors... 3. Sensitivity of the organism: Assessed on basis of MIC values & postantibiotic effect 4. Relative toxicity: Less toxic antibiotic is preferred e.g. β-lactam over aminoglycoside 5. Pharmacokinetic profile: For optimum action antibiotic has to be present at site of infection in sufficient conc. for adequate length of time 26 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 27. Drug related factors...  For many organisms, aminoglycosides, fluoroquinolones & metronidazole - ‘concentration-dependent inhibition’  For many organisms, β-lactams, glycopeptides & macrolides - ‘time-dependent inhibition’  Penetration to site of infection - drug which penetrates better & attains higher conc. at site of infection 6. Cost: Less expensive drugs are to be preferred 27 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 28. Drug related factors... 7. Routes of administration:  Parenteral therapy: • Seriously ill patient, where effective drug conc. are required rapidly at site of infection • Drugs not orally absorbed e.g. aminoglycosides • Oral route is contraindicated  Oral therapy  Topical therapy • Superficial skin infections, mucosal candidiasis, middle ear & superficial ocular infections 28 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 29. Drug related factors... 8. Dosage regimens: – Dose influenced by severity of infection, age & weight – Standard treatment guidelines should be followed 9. Encouraging compliance: – Less frequency improves compliance 10. Length of treatment: – Depends upon site & severity of infections, causative organisms & patient’s response to treatment 29 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 30. Combination therapy • Objectives: 1. To achieve synergism: Manifests in terms of ↓ in MIC of one antimicrobial agents in presence of another or MICs of both may be ↓ • General guidelines: (a) Two bacteriostatic agents are often additive, rarely synergistic (b) Two bactericidal drugs are frequently additive & sometime synergistic if organism is sensitive to both 30 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 31. Combination therapy… (c) Combination of a bactericidal with bacteriostatic drug may be synergistic or antagonistic depending on organism  If organism is highly sensitive to cidal drug—response to combination is equal to static drug given alone (apparent antagonism)  If organism has low sensitivity to cidal drug—synergism 31 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 32. Combination therapy… 2. To reduce severity or incidence of adverse effects: Possible only if combination is synergistic - doses can be ↓ 3. To prevent emergence of resistance:  Principle of using two or more antimicrobial agents together is valid primarily for chronic infections needing prolonged therapy  If incidence of resistant mutants of bacillus infecting individual for drug A is 105 and for drug B is 107, then only one out of 1012 bacilli will be resistant to both 32 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 33. Combination therapy… 4. To broaden spectrum of antimicrobial action (a) Treatment of mixed infection - aerobic & anaerobic organisms sensitive to different drugs are often involved (b) Initial treatment of severe infections - drugs covering gram-positive and gram-negative (in certain situations anaerobes as well) (c) Topically - AMAs which are not used systemically, are poorly absorbed from local site & cover broad range of bacteria 33 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 34. Disadvantages of combinations • Foster casual rather than rational outlook in diagnosis of infections & choice of antimicrobial agents • ↑ incidence & variety of ADRs. Toxicity of one agent may be enhanced by another • ↑ chances of superinfections • If inadequate doses of non-synergistic drugs are used— emergence of resistance • Higher cost of therapy 34 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 35. The Council for Appropriate and Rational Antibiotic Therapy (CARAT) • CARAT is independent, multidisciplinary panel of healthcare professionals, clinicians as well as scientists, established to advocate appropriate & accurate use of antibiotics 35 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 36. CARAT criteria  Evidence based results  Therapeutic benefits  Safety  Cost-Effectiveness  Optimal drug dose and duration 36 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 37. Evidence based results • In choosing an antibiotic, clinicians should consider clinical evidence –  Drug is clinically and microbiologically appropriate  Efficacy of drug in well-designed clinical trials  Antibiotic resistance pattern of local region • Well conducted, randomized, controlled clinical trials provide highest quality information for making decisions 37 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 38. Therapeutic Benefits • Key to applying evidence-based results & making appropriate therapeutic choices for each patient involves determining correct diagnosis & analyzing therapeutic benefits of possible treatments • To maximize patient health & reduce unnecessary prescribing, therapeutic benefits of each drug should be considered relative to status of patient’s infection 38 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 39. Therapeutic Benefits… • Clinician must consider any evidence that particular antibiotic can result in clinical & microbiologic cure as well as treatment failures associated with absence of drug treatment • If possible, clinician should identify causative pathogen & use surveillance data on regional antibiotic resistance patterns in selecting optimal therapeutic agent 39 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 40. Safety • Clinically applicable treatment strategies should be chosen to maximize efficacy while minimizing side effects • In study, between 1975 and 2000, 548 new chemical entities were approved for use in US; 45 of these (8.2%) acquired new black-box warnings & 16 (2.9%) were withdrawn from market during this time • Of 16 withdrawn from market, 8 were withdrawn within 2 years after their introduction • E.g. Temafloxacin was withdrawn 0.3 years after introduction and grepafloxacin was withdrawn 2.0 years after introduction 40 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 41. Cost effectiveness • Choosing inappropriate therapy is associated with increased costs, including cost of antibiotic & increases in overall costs of medical care Due to treatment failures and adverse events • Using optimal course of antibiotics can have economic as well as clinical advantages • Outpatients may experience faster return to their normal daily routine & earlier return to work 41 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 42. Optimal Drug for Optimal Duration • Optimal drug selection requires finding antimicrobial class & specific member of that class • Because empiric therapy is used in most cases: - Etiologic agent - gram +VE or gram –VE ? - Narrow or broad-spectrum agent ? - Resistance patterns of likely pathogen to this drug, both nationally and regionally & - Individual patient’s medical history, including recent antibiotic exposure 42 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 43. Optimal Drug for Optimal Duration… • Optimal duration: Prescribing selected drug for shortest amount of time required for clinical & microbiologic efficacy – Decreased side effects – Increased patient adherence – Decreased promotion of resistance – Decreased cost 43 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 44. The pipeline is drying up! US FDA approval of new antibacterials down 56% from 1983 to 2002  Infectious diseases are still most common cause of death worldwide  We are effectively living in post-antibiotic era  Therefore, we must manage carefully and responsibly what we have 44 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 45. Science magazine; July 18, 2008 The last decade has seen inexorable proliferation of a host of antibiotic resistant bacteria, or bad bugs, not just MRSA, but other insidious players as well… For these bacteria, the pipeline of new antibiotics is verging on empty. 'What do you do when you're faced with an infection, with a very sick patient, and you get a lab report back and every single drug is listed as resistant?' asked Dr. Fred Tenover, Centers for Disease Control and Prevention (CDC). 'This is a major blooming public health crisis.’ 45 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 46. Best way to keep the matters in order • Nearly 50% of hospitalized patients receive antimicrobial agents • Every hospital should have a policy which is practicable to their circumstances • Rigid guidelines without coordination will lead to greater failures • Only way to keep antimicrobial agents useful is to use them appropriately & judiciously 46 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 47. National Policy • Government of India - National policy for containment of antimicrobial resistance in 2011 • Aims & objectives: 1. Understanding emergence & spread of antimicrobial resistance & the factors influencing it 2. Establish nationwide well coordinated antimicrobial program with well defined & interlinked responsibilities & functions of different arms of program 47 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 48. National policy for containment of antimicrobial resistance in 2011... 3. Rationalizing usage of available antimicrobials 4. Reducing antibiotic selection pressures by appropriate control measures 5. Promotion of discovery of newer & effective antimicrobials based on current knowledge of resistance mechanisms 6. Rapid and accurate diagnosis of infections & infectious diseases 48 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 49. Antibiotic policy • A corporate document that is designed to further the aim of the hospital to provide a high standard of patient care • Principles of antibiotic policy were laid down in 1980s 49 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 50. Antibiotic policy… • Educational programs designed to improve antibiotic uses • Controls operated through Pharmacy department – Creation of hospital pharmacopeia – Written justification for costlier & broader spectrum antibiotics – Introduction of concept of stop orders – Automatic changes from IV to oral antibiotic therapy – Sponsoring of antibiotics according to their usage e.g. prophylaxis, specific therapy, therapeutic trials etc. 50 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 51. Antibiotic policy… • Controls through laboratory in form of reporting, regular issue of resistance / susceptibility patterns & active consultations • Establishment of antibiotic advisory service in hospitals • Publication of consensual antibiotic policy for special use e.g. prophylaxis & specialized clinical units • Audit of antibiotic usage; antibiotics as a class of drugs accounts for largest expenditure in health care system 51 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 52. Antibiotic policy… • Promotion of ethical relationship between the pharmaceutical companies, prescribers and pharmacists • Regulation of antibiotic usage in veterinary practices. All veterinary antibiotics should need prescription • Monitoring of antibiotic residues in food of animal origin • Encourage research to develop new molecules Infectious Disease Society of America’s “10 × ‘20 initiative” 52 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 53. What can we do ? 53 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 54. Promoting rational prescribing • Standard treatment guidelines - when evidence- based, developed with end-users, with active dissemination & follow-up • Essential medicines lists - when linked to treatment guidelines & used for training & supply • Hospital Drugs & Therapeutic Committees • Undergraduate training • Comprehensive approach, with all components 54 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 55. Possible interventions in private sector • Regulation: Market approval, re-licensing, re-evaluation per therapeutic category, regulation of promotion, ban over-the-counter (OTC) sale of antimicrobials • Training: Basic training, national clinical guidelines, CMEs by universities & professional bodies, re-licensing of professionals on basis of education points, medical audit, patient information leaflets, public education 55 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 56. Possible interventions in private sector... • Financial incentives: Separate prescribing from dispensing, dispensing fee (flat or tiered), price controls on generic / brand drugs, contracting out • Insurance: Reimbursement limited to essential medicines, reference pricing 56 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 57. Educating Practitioners • Seminars • Panel discussion • Updates 57 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 58. Don’t let the advertisements block our intelligence !!! ***Read the fine prints  The drug is 10 times more potent but may cause renal damage in some  The most effective antibiotic For what? At what cost? What duration? 58 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 59. Educating Consumers No self medication No own antibiotic kit Emphasis on dose and duration 59 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 60. Standard Treatment Guidelines  A systematically developed statement to assist practitioners in making decisions about appropriate health care for specific clinical conditions  These guidelines should be tailored to local situations and specific to levels of care  From national level to hospital level 60 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 61. Key features of standard treatment guidelines • Simplicity • Credibility • Same standard for all levels • Drug supply based on standard treatment guidelines • Introduce in pre-service training • Dynamic (regular updates) • Handy pocket books 61 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 62. Increasing use of diagnostic tests • Lack of adequate, well equipped laboratory facilities • Under-utilization of microbiological labs • Ministry of Health & Family Welfare recommends for increase in utilization of diagnostic tests in clinical practice • Newer rapid molecular diagnostic tests –  Peptide nucleic acid technology  Matrix-assisted laser desorption/ionization technology  rapid polymerase chain reaction 62 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 63. Surveillance • Two complementary types of surveillance - – Surveillance for antibiotic resistance – Surveillance for antibiotic use • Knowing resistance levels & tracking them over period of time is powerful tool to support real changes • Once link between resistance & antibiotic is accepted, tracking antibiotic use can be used as surrogate for changes in antibiotic resistance 63 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 64. Surveillance…  Sentinel surveillance for antimicrobial resistance: • Provides only indicative data, but the same can be extrapolated to rest of population • Suitable mode of surveillance when prolonged & detailed data is needed • Best approach for our country 64 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 65. WHONET Software • Free Windows-based database software • Developed for management & analysis of microbiology laboratory data with special focus on analysis of antimicrobial susceptibility test results • Used by clinical, public health, veterinary & food laboratories in over 90 countries to support local & national surveillance programs 65 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 66. Proposed care bundles for antibiotic prescribing • Acute care: initiation of therapy  Document clinical rationale for antibiotic initiation  Collect & send appropriate specimens to microbiology laboratory  Select antibiotic therapy according to local policies (i.e., local antimicrobial susceptibilities) & risk group (exclude drug allergy)  Consider removal of foreign body/drainage of pus/surgical intervention 66 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 67. Proposed care bundles for antibiotic prescribing... • Acute care: continuation of therapy  On daily basis, consider de-escalation, parenteral-to-oral conversion, or discontinuation of antibiotic therapy based on clinical signs & symptoms and laboratory test results  Monitor serum antibiotic conc. in accordance with local policies 67 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 68. Proposed care bundles for antibiotic prescribing... • Surgical prophylaxis:  Select antibiotic therapy based on local guidelines (i.e., local antimicrobial susceptibilities) & type of surgery (exclude drug allergy)  Give first dose within guideline-defined time before incision  Discontinue antibiotic therapy within guideline defined time after first preoperative dose or surgical end time 68 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 69. Infection prevention & control methods for controlling antimicrobial resistance in hospitals • Hand hygiene • Contact (i.e. barrier) precautions • Active surveillance for and decolonization (i.e. eradication) of multidrug-resistant organisms • Preoperative antimicrobial prophylaxis 69 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 70. Infection prevention & control methods for controlling antimicrobial resistance in hospitals... • Implementation of best practices for invasive procedures & devices (e.g., removal of unnecessary central catheters) • Disinfection & sterilization of medical devices • Environmental cleaning 70 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 71. Antimicrobial stewardship • Definition – The optimal selection, dosage & duration of antimicrobial treatment that results in the best clinical outcome for the treatment or prevention of infection, with minimal toxicity to the patient and minimal impact on subsequent resistance 71 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 72. Goals of antimicrobial stewardship • To work with health care practitioners to help each patient receive most appropriate antimicrobial with correct dose and duration • To prevent antimicrobial overuse, misuse & abuse • To minimize development of resistance • Reduction of health care costs without adversely impacting quality of care 72 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 73. Antibiotic stewardship team Collaboration between antimicrobial stewardship team, hospital infection control, pharmacy, therapeutics committees & hospital administration is essential  Infectious Disease Physician  Clinical Pharmacist with infectious disease training  Clinical Microbiologist  Information system specialist  Infection control professional  Hospital epidemiologist (Optional) 73 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 74. Antibiotic stewardship team… • Functions- – Providing high standard of patient care – Improving rational utilization of antibiotic – Pharmacovigilance of antimicrobial – Effective utilization of financial resources in purchase of antimicrobials – Curbing emergence of microbial resistance 74 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 75. The Antibiotic Resistance Declaration • May 2014, Antibiotic Resistance Coalition - ‘Declaration on Antibiotic Resistance’ to advocate for policy change & action to prevent post-antibiotic era from becoming a bleak reality • Chennai Declaration: December 2012 A document, prepared by representatives of various stakeholders and eminent experts in India, to tackle the challenge of anti-microbial resistance from an Indian perspective 75 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 76. Use of antibiotics wisely - The only solution • Before taking any antibiotic ask your physician if it is required & beneficial • Always take antibiotics as prescribed by physician • Take antibiotics to treat only bacterial infections • Don’t take antibiotics in viral infections such as cold, cough or flu • Don’t repeat same antibiotic for next time you get sick 76 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 77. Use of antibiotics wisely - The only solution... • Don’t stop antibiotic before complete prescribed course of treatment • Don’t skip doses • Don’t copy antibiotic with same diseases which is prescribed for someone else • Educate yourself & talk to your physician about antibiotic resistance 77 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 78. 78 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 79. 79 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 80. “The public will demand [the drug and] … then will begin an era … of abuses. The microbes are educated to resist penicillin and a host of penicillin-fast organisms is bred out which can be passed to other individuals and perhaps from there to others until they reach someone who gets a septicemia or a pneumonia which penicillin cannot save. In such a case the thoughtless person playing with penicillin treatment is morally responsible for the death of the man who finally succumbs to infection with the penicillin-resistant organism. I hope the evil can be averted.” - Alexander Fleming, 1945 80 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 81. Summary • Infectious diseases are still serious problem, compounded by development of antibiotic resistance in many bacteria & relative lack of newer antimicrobial agents to combat these multi-resistant organisms • Appropriate aggressive short-course treatment is recommended for ensuring clinical & microbiologic cure, optimal patient adherence & minimal generation of antibiotic resistance 81 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 82. • Ideally, institution of 5 CARAT criterias will optimize safe & well-tolerated treatment regimens, curb unnecessary prescribing of antibiotics, decrease treatment costs & increase adherence • By making antimicrobial stewardship part of our daily practice, we can improve patient safety & care, reduce unnecessary use of valuable resources & reduce resistance • Thus, antibiotic prescribing should be prudent, thoughtful & rational 82 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 83. References • Goodman & Gilman’s The Pharmacological Basis of Therapeutics 12th Edition • R.S. SATOSKAR. PHARMACOLOGY AND PHARMACOTHERAPEUTICS 24th EDITION • Bertram G. Katzung & Anthony J. Trevor’s Basic & Clinical Pharmacology 13th Edition • National policy for containment of antimicrobial resistance, India 2011. 1 of 82 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 84. References... • Vance MA, Millington WR. Principles of irrational drug therapy. Int J Health Serv. 2010;16(3):355–61. • National Nosocomial Infections Surveillance (NNIS) System Report, data summary from January 1992 through June 2003, issued August 2003. Am J Infect Control. 2003;31(8):481-498 • Dellit TH, Owens RC, McGowan JE Jr, et al. IDSA and SHEA guidelines for developing an institutional program to enhance antimicrobial stewardship. Clin Infect Dis. 2007;44(2):159-177 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 85. References... • Gerding DN. The search for good antimicrobial stewardship. Jt Comm J Qual Improv. 2001;27(8):403- 404 • Thomas G. Slama et al. A clinician’s guide to the appropriate and accurate use of antibiotics: the Council for Appropriate and Rational Antibiotic Therapy (CARAT) criteria. doi:10.1016/j.amjmed.2005.05.007 • “Chennai Declaration” Team. “Chennai Declaration”: 5-year plan to tackle the challenge of anti-microbial resistance. IJMM, (2014) 32(3): 221-2281 Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017
  • 86. Thank you !!! Rational use of antibiotics & antibiotic policy – Dr. Vikas S. Sharma 11th January 2017