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ANTIMICROBIAL STEWARDSHIP
DR.P.B.PRAVEENKUMAR
SECOND YEAR POST GRADUATE
DEPARTMENT OF MICROBIOLOGY
THANJAVUR MEDICAL COLLEGE
SYNOPSIS
• INTRODUCTION OF AMSP
• IMPLEMENTATION OF AMSP
• MONITORING OF AMSP
• CURRENT SCENARIO OF AMR AND ROLE OF AMR
SURVEILLANCE
• AMS IN SPECIAL SITUATIONS
• ONE HEALTH APPROACH
• ANTIBIOGRAM
• ANTIFUNGAL STEWARDSHIP
• ANTIVIRAL STEWARDSHIP
ANTIMICROBIAL STEWARDSHIP
It is an inter-professional efforts across the
continuum of care that involves
• Timely and optimal selection, dose and
duration of an antimicrobial
• For the best clinical outcome for treatment or
prevention of infection
• With minimal toxicity to the patient
• And minimum impact on resistance and other
ecological adverse events
WHO DEFINITION OF AMS
Stewardship – Careful and responsible management
of something entrusted to one’s care
AMS – Coherent set of actions which promote the
responsible use of antimicrobials at
individual/national/global level
AMS Program – Organization or system wide health
care strategy to promote the appropriate use of
antimicrobials through the implementation of
evidence based interventions
CDC DEFINITION OF AMS
The use of the right antimicrobial, for the right
patient at the right time, with the right dose,
route and frequency, causing the least harm to
the patient and future patients
IDSA DEFINITION OF AMS
Co-ordinated interventions designed to
improve and measure the appropriate use of
antimicrobials by promoting the selection of
the optimal antimicrobial drug regimen, dose,
duration of therapy and route of
administration
EIGHT 8Ds OF AMS
• Diagnosis
• Drug
• Dosage
• Diagnostics
• De-escalation
• Duration
• Debridement/Drainage
• Disease prevention and control measures
WHY AMSP IS NEEDED?
• To prevent antimicrobial resistance
• Misuse and overuse of antimicrobial agents
• Use of antimicrobials in other sectors
• Poor antimicrobial research
SELECTIVE PRESSURE THEORY
ANTIMICROBIAL USAGE IN OTHER
SECTORS
ANTIMICROBIAL PRESCRIPTION
30% RULE
• 30% of hospitalized patients at any given time
receive antimicrobial agents
• 30% of antimicrobials prescribed
inappropriately in the community
• Up to 30% of surgical prophylaxis is
inappropriate
• 30% of hospital pharmacy costs are due to
antimicrobial use
• 10-30% pharmacy costs can be saved by
antimicrobial stewardship programs
GOALS OF AMS
• Reduce antimicrobial resistance
• Improve patient outcomes
• Improve patient safety through minimizing
unintended consequences of antimicrobials
• Reduce health care cost towards antimicrobial
drugs without affecting quality
AID INTEGRATED STEWARDSHIP
MODEL
• Antimicrobial stewardship
• Infection control stewardship program
• Diagnostic stewardship
PYRAMID PLATFORM TO ILLUSTRATE
AID MODEL
DIAGNOSTIC STEWARDSHIP
Three components
• Ordering the right test
• Performing the test by the right method
• Communicating the results within the right
time
AWARE CLASSIFICATION- PURPOSE OF
THIS CLASSIFICATION
• To monitor antimicrobial consumption
• Defining targets and monitoring effects of the
antimicrobial stewardship policies
GOAL OF AWARE CLASSIFICATION
By the end of 2023, WHO aims country level
target of at-least 60% of total antimicrobial
consumption from Access group & less than
40% from watch and reserve group
THREE GROUPS
• Access (87 drugs as per 2021 update) – 21*
• Watch (141 drugs as per 2021 update) – 12*
• Reserve (29 drugs as per 2021 update) – 8*
NOTE: Each group is having one division called
as ESSENTIAL MEDICINES (EML) for empirical
treatment
(* )- WHO EML list
ACCESS GROUP
• Includes antimicrobials that have activity
against a wide range of community
encountered susceptible pathogens while also
showing lower resistance potential than
antimicrobials in other group.
ACCESS GROUP (EML LIST)-21 DRUGS
• Benzyl penicillin
• Benzathine benzyl
penicillin
• Phenoxymethyl
penicillin
• Ampicillin
• Amoxicillin
• Amoxicillin-clavulanate
• Cefalexin
• Cefazolin
• Cloxacillin
•Gentamicin
•Amikacin
•Spectinomycin
•Doxycycline
•Cotrimoxazole
•Chloramphenicol
•Nitrofurantoin
•Clindamycin
•Metronidazole (IV)
•Metronidazole (Oral)
WATCH GROUP
• Includes antimicrobials that have higher
resistance potential and includes most of the
highest priority agents among the critically
important antimicrobials for human medicine
• Antimicrobials in WATCH group should be
prioritized as key targets for stewardship
programme.
WATCH GROUP (EML LIST)-12 DRUGS
• Cefuroxime
• Cefotaxime
• Ceftriaxone
• Ceftazidime
• Cefixime
• Ciprofloxacin
• Azithromycin
• Clarithromycin
• Piperacillin tazobactam
• Meropenem
• Vancomycin (IV)
• Vancomycin (Oral)
RESERVE GROUP
• Includes antimicrobials and agents that should
be reserved for treatment of confirmed or
suspected infections due to MDRO
• Considered as LAST RESORT when every other
alternatives failed.
• These drugs could be protected and
prioritized as key targets of antimicrobial
stewardship programme and monitoring.
RESERVE GROUP (EML LIST)-8 DRUGS
• Ceftazidime-avibactam
• Meropenem-vaborbactam
• Colistin
• Polymyxin B
• Fosfomycin
• Linezolid
• Cefiderocol
• Plazomicin
BARRIERS IN IMPLEMENTATION OF
AMSP
• Clinician knowledge deficit on usage of
antimicrobials and opposition from their side
• Limited access of antimicrobials
• Fear of poor outcome by withholding
antimicrobials
• Lack of communication among health care
workers
• Limited public/patient acceptance of AMSP
• OTC sales of antimicrobial drugs
IMPLEMENTATION OF AMSP
CORE ELEMENTS OF AMS PROGRAM
• WHO Check list
• CDC Check list
CORE ELEMENTS – WHO CHECK LIST
• NAP (National Action Plan) on AMR states that
AMS is a national priority
• Dedicate funding for national action plan on
AMR
• Technical working group on AMS
• Defined goals, outcomes, timelines and
structures has been developed
• Monitoring and evaluation mechanism for
NAP on AMR
CORE ELEMENTS – WHO CHECK LIST
(cont.)
• Integration of AWARE classification of antibiotics
with WHO essential medicines list
• Up to date clinical guidelines includes AMS
principles and integrate with AWARE antibiotics
• Regulations of fixed dose combinations of drugs
• Regulations on prescription only sales of
antibiotics
• Ensure continued availability of quality assured
antibiotics
• Ensure affordability of essential antibiotics
CORE ELEMENTS – WHO CHECK LIST
(cont.)
• Public antibiotic awareness campaigns
• Education in schools on basic infection control
principles
• Training on AMS competencies for AMS team
members
• Education and training given to health care
workers
• Incentives to support AMSP implementation
CORE ELEMENTS – WHO CHECK LIST
(cont.)
• National surveillance system on antimicrobial
consumption
• National surveillance system on AMR in place
with laboratory capacity
• Diagnostic tests are available and capacity
building are undertaken to optimise
antimicrobial use
CDC CORE ELEMENTS CHECK LIST
STEPS OF IMPLEMENTATION OF AMS
PROGRAM IN A HOSPITAL
• Administrative support (Leadership)
• Set up AMS committee and AMS team
• Multi disciplinary support
• Framing antimicrobial policy
• Implementing stewardship strategies
• Education and training
AMS COMMITTEE
TYPES
• Stand alone type (Preferable)
• Integrated type (Saves time)
AMS COMMITTEE MEMBERS
• Health care facility leadership (Medical
director/Medical superintendent) – CHAIR
PERSON
• AMS team members
• HODs of various departments including
microbiology and pharmacology in particular
• In-charges of intensive care units
• Nursing superintendent
• AMS Steward – Member secretary
AMS COMMITTEE (cont.)
• Meeting not less than once in three months
• At-least a week prior notice via mail or letter to
all departments
• On that particular day reminder is must
• Presentation on AMR current trend in our
hospital
• Review of last meeting
• The minutes of meeting should be documented
CORE MEMBERS OF MULTI
DISCIPLINARY AMS TEAM
• Infectious diseases physician (FIRST CHOICE)
• Infection control officer
• Clinical microbiologist
• Internal medicine physician
• Clinical pharmacists with infectious disease
training
• AMS nurses with infectious diseases training
• Officer in charge of pharmacy
• Clinical pharmacologist
ANTIBIOTIC STEWARD QUALITIES
• He/she is the central driving force behind this
program
• Having skills like communication, teamwork
• Ability to influence others
• Commands the respect of peers
• Inspires trust with all stakeholders
• Motivates the team
• Possesses the long range perspective
• Creates and recognises opportunity
ANTIBIOTIC STEWARD QUALITIES
• Influence prescriber’s decision making
• Clinical expertise
• Antimicrobial expertise
• Microbiological expertise
• IPC Expertise
ID PHYSICIAN
• First choice to lead AMS team
DISADVANTAGES
• Paucity of ID physicians in India
• Lack of vacant posts in government sectors
• Lack of time allotment to do stewardship work
ID COURSES
(NMC AND DNB RECOGNIZED)
INFECTION CONTROL OFFICER
• Mostly ICO will be clinical microbiologist since
they are expert in infection control
stewardship
DISADVANTAGES
• Insufficient clinical expertise
• Limited knowledge of treatment guidelines
and antimicrobial drugs
• But at the same time if ICO is from non-
microbiological background then diagnostic
stewardship will be big challenge
INTERNAL MEDICINE PHYSICIAN
• Much better than ID physician
• Having through clinical knowledge
• More familiar with clinical work practice and
ward rounds
DISADVANTAGES:
• Limited and suboptimal knowledge on
diagnostic and infection control stewardship
CLINICAL PHARMACIST
• Well fit for western countries
ROLE:
• Prescription audit
• Separate rounds in ward and then rounds with
AMS steward to save the time for AMS steward
• Pharmacokinetic monitoring
• Drug allergy monitoring
• Discharge advisory for the patients
• Educating the patients and other health care
workers
HAND SHAKE STEWARDSHIP
In 2019, CDC introduces
hand shake stewardship
with pharmacists and
physicians for effective
implementation of
AMSP in hospital
LIMITATIONS OF CLINICAL
PHARMACIST
• Lack infection control and microbiological
expertise
• Lacks clinical knowledge
• Paucity of ID trained clinical pharmacists in
India
STEWARDSHIP NURSES
• Advantages are availability of nurses is high,
Sufficient IPC knowledge, Familiar with
hospital work flow
ROLE:
• Ensure collection of proper samples
• Keeping track on laboratory reports
• To keep a check on administrative errors
(Dose, route of administration)
• Educating the patient
• AMS audit
OFFICE INCHARGE OF PHARMACY
• Member should be from pharmacology
department (Faculty)
• List of antimicrobial agents available
• Quality assurance
• Formulary restriction
• Pre authorization for restricted drugs
• Automatic stop order
CLINICAL PHARMACOLOGIST
• Contributing formulation of antimicrobial
policy
• Therapeutic drug monitoring
• Training of pharmacists
• Look for drug-drug interactions, adverse
effects and pharmacovigilance
MULTI DISCIPILINARY SUPPORT
• Support from microbiology laboratory
• Support from pharmacology laboratory
• Support from HICP unit
• Link between IPC and AMS
• Support from IT wing
• Role of individual stake holders in AMSP
LINK BETWEEN IPC AND AMS
“GUIDELINE NOT MINDLINE”
• Physicians should strictly adhere to the
guidelines for rationalizing the antibiotic use
rather following mind lines (View of peer or
senior physicians or local practice or pressure
from medical representatives)
FRAMING ANTIMICROBIAL POLICY
It includes
• Title page
• Goal of AMSP
• List of available antimicrobials
• General guidelines
• Antibiogram data of last year
• Treatment regimen for system wise
All guidelines based on IDSA, Sanford’s guide, ICMR,
NCDC, Mandell, Doughlas and Bennett’s principles and
Harrison’s Principles of Internal Medicine
ROLE OF INFORMATION TECHNOLOGY
IN AMS
• By providing clinical decision support system
(CDSS)
• Recording and facilitating the informational
workflow
• By helping implementation and monitoring of
AMS interventions
HEALTH CARE IT SERVICES
• Hospital information system (HIS)
• Laboratory information system (LIS)
• Electronic Medical record (EMR)
• Electronic Health record (EHR)
• Ayushman Bharat Digital Mission – ABHA
number
• Personal Health records (PHR)
BENEFITS OF LIS
• Data entry
• Tracing of reports
• No risk of losing data
• Statistics
• Online access to reports
• Critical alerts
• Bidirectional communication between
laboratory and wards
ABHA NUMBER AND IT’S BENEFITS
The citizens need to create an Ayushman Bharat
Health Account (ABHA) number by linking to
unique identifier such as Aadhar card
• Unique and trustable identity
• Unified benefits
• Hassle free access
• Easy PHR sign up
CDSS (COMPUTERIZED DECISION
SUPPORT SYSTEMS)
• Defined as computer applications designed to
aid clinicians in making diagnostic and
therapeutic decisions in patient care and
thereby improving antimicrobial use
CDSS AT PHYSICIAN LEVEL
RESTRICTIVE APPROACH:
• Physicians can use this platform for usage of
restricted and semi-restricted drugs
PERSUASIVE APPROACH:
• Includes clinical practice, treatment algorithm,
antimicrobial policy, local antibiogram
CDSS AT AMS TEAM LEVEL
POST PRESCRIPTION REVIEW:
• Incorporating data from multiple systems such
as microbiology, pharmacy
CONSUMPTION AUDIT:
• To monitor and measure the impact of AMSP
program.
TYPES OF ANTIMICROBIAL CDSSs
1. SIMPLE CDSS
2. COMPLEX CDSS
• Electronic guidelines and mobile applications
• Electronic antimicrobial approval systems
• Electronic infection prevention control and
surveillance systems
• EPS and EMM systems (Electronic prescribing
system and Electronic medication management)
• Clinical microbiology decision support systems
• Advanced decision support systems
ELECTRONIC GUIDE AND MOBILE
APPLICATIONS
MOBILE BASED APPLICATIONS DEVELOPED BY
Sanford guide online Sanford Guide, USA
John Hopkin Antibiotic guide John Hopkins, medicine, USA
EMRA antibiotic guide Emergency medicines residents
association, USA
Microguide Horizon strategic partners, UK
AIIMS antibiotic policy AIIMS, Delhi
ICMR treatment guidelines for
antimicrobials in common syndromes
ICMR, India
UptoDate Online Provide various information about
infectious diseases
MedScape
ELECTRONIC IPC AND SURVEILLANCE
SYSTEMS
• Safety surveillor and Theradoc systems,
Premium Healthcare, North carolina
• MedMined CareFusion, BD, New Jersey
• Sentri7, Wolters Kluwer
• RL solutions RL, Canada
• Ibhar IPC module, JIPMER, India (IPC module,
CMR module, AMS module)
INTERVENTION OF AMSP
Front end strategy (Restrictive strategy)
• Intervention applied actively on prescribers
usually before (Sometimes after) prescribing
antimicrobials
Back end strategy (Persuasive/passive strategy)
• Intervention applied passively on clinicians
usually after (Sometimes before) prescribing
antimicrobials
Additional strategy (Resource driven & Guideline
based interventions)
FRONT END STRATEGY
• Formulary restriction with preauthorization
• Antibiotic cycling
• Antibiotic mixing
• Automatic stop orders
• Computer physician order entry
• Selective susceptibility reporting from the lab
FORMULARY RESTRICTION WITH
PREAUTHORIZATION
Formulary restriction:
• Restricting dispensing of targeted antimicrobials
on the hospital’s formulary (Pharmacy) according
to certain predefined approved criteria
Preauthorization:
• Authorization of the targeted antimicrobials by
the AMS team is needed to procure them from
the hospital formulary
ONLY DISADVANTAGE FOR FRP IS THAT THIS WILL
BE APPLICABLE ONLY WHEN PRESCRIBERS USING
E-PRESCRIPTION.
IMPORTANT POINTS ABOUT FRP
• Deciding the antimicrobials based on local AMR
pattern, speciality, suspected clinical diagnosis.
• We can adapt WHO AWARE classification for FRP
strategy (Unrestricted, semi-restricted, restricted
drugs)
• Pre-authorization (Compulsory order form) to be
filled by prescribers
• 24*7 (Round O’ Clock) duties for AMS team to
give approval
PRE AUTHORIZATION FORM
ANTIBIOTIC CYCLING
• Withdrawal of an antimicrobial agent or
antimicrobial class from general use (Within a
ward or institution) for a designated period of
time and it’s substitution with antimicrobial
agent from different class having a
comparable spectrum of activity, but for which
organism may have different resistance
mechanisms.
ANTIBIOTIC MIXING
• Consecutive patients with same diagnosis
receive an antibiotic from a different class in
rotation
AUTOMATIC STOP ORDERS
• To encourage the prescribers to routinely
review the antimicrobial prescriptions for their
appropriateness
• Usually performed by AMS team and
pharmacy
ANTIMICROBIAL SUPPRESSION
• Withholding (Not releasing) the antimicrobial
susceptibility test (AST) results of certain
antimicrobial agents from the final patient
report. (NOT IN ROUTINE ANTIBIOGRAM)
• Purpose: To encourage appropriate use of
antimicrobial agents.
• Antimicrobial suppression will be done by
THREE METHODS.
THREE METHODS OF ANTIMICROBIAL
SUPPRESSION
• Selective reporting
• Cascade reporting
• Testing limitation
SELECTIVE REPORTING
Reporting results for specific antimicrobial
agents while suppressing others based on
some criteria
• Organism identification
• Mechanism of resistance
• Body site
• Clinical setting
• Patient demographics
• Aberrant results
• Unavailability of clinical breakpoints
ORGANISM IDENTIFICATION
CLINICALLY INEFFECTIVE CLINICALLY NOT REPORTED
Drugs may display susceptible
results in in vitro but clinically
ineffective.
Example:
1st or 2nd generation
cephalosporins and
aminoglycosides for salmonella
infections
Drugs which are effective
against organism but no break
points available. So not
reported.
Example:
Cefepime, Piperacillin
tazobactam, meropenem,
imipenem, ertapenem effective
against salmonella, but not
reported since no breakpoints
given by CLSI
MECHANISM OF RESISTANCE
• No need to modify the AST reports even if
any organism is found to be ESBL / AmpC
producing.
BODY SITE
No..ssssss in AST report
Respiratory specimen – Daptomycin
CSF – 1st,2nd generation cephalosporins,
erta/doro/imipenem, clindamycin, tetracycline,
macrolides, quinolones, aminoglycosies
Urine specimen – Chloramphenicol, macrolides,
clindamycin
Non urine specimens – Ciprofloxacin, levofloxacin,
nitrofurantoin, norfloxacin, nalidixic acid
CLINICAL SETTING
• IV drugs – OPD setting C/S report
• Impaired RFT patients – Aminoglycosides,
colistin, vancomycin
PATIENT DEMOGRAPHICS
• Suppress antibiotics with known adverse
effect.
Example:
Ciprofloxacin, chloramphenicol & tetracycline
supressed from pediatric case reports
ABERRANT RESULTS
• First line drugs are susceptible, second line
drugs are resistant.
So, here suppress the second line drug status.
Example:
Ceftriaxone – S
Meropenem - R
UNAVAILABILITY OF BREAKPOINT
• Don’t report that particular drug if breakpoint
is not available.
EVEN DON’T ADMIT IT IN ANTIBIOGRAM
POLICY
CASCADE REPORTING
• Reporting of AST results involves reporting of
broader spectrum/costlier/second line drugs
only when narrow spectrum/cheaper/first
line drugs are found to be not susceptible
THINGS TO BE REMEMBER WHILE
CASCADE REPORTING
• Pharmacy availability of drug
• Local antimicrobial resistance
• Clinical consensus and patient status
• Following standard guidelines like CLSI or
EUCAST
• Cascade reporting not cascade testing
• Inclusion into antibiogram (Except BP not
available)
BACK END STRATEGY
• Audit and feedback
• Pathogen directed AMS audit
• Antimicrobial advices driven interventions
• Prescription audit
• Antibiotic time outs/Review/Self revision
• Dosage optimization
• Automatic alerts
• Behaviour change
• Educational intervention
AUDIT AND FEEDBACK
• Assessment of prescribed antimicrobial
treatment, subsequently providing feedback
on inappropriate antibiotic prescription to the
clinical team
TYPES:
• Prospective (Real time) audit with feedback
(Preferable)
• Retrospective Audit with feedback
PROSPECTIVE VS RETROSPECTIVE
PROSPECTIVE RETROSPECTIVE
Audit is conducted in real time Audit is conducted retrospectively
Feedback is provided in real time, so that
clinicians will ask doubts and get clarified
It doesn’t happen
Feedback on individual patient
prescription provided
Overall feedback on antimicrobial use of
the location is provided
Opportunity to modify individual patient
prescription
No opportunity to modify
Opportunity to educate and training of the
clinical team
No opportunity for that
More time stringent since it’s real time
audit
Greater flexibility in timing to conduct the
audit
AUDIT AND FEEDBACK
(Stage wise approach)
• One stage approach – AMS team rounds along
with clinical team
• Two stage approach – Clinical pharmacist ID
trained, Infection control nurse rounds first
and then rounds with clinical team, ID
physician & Clinical microbiologist
PATHOGEN DIRECTED AMS AUDIT
(PD AMS AUDIT)
• It is a modification of prospective audit and
feedback in which the audit is conducted
prospectively for the patients with culture
proven infections by
telephonic/Bedside/Written communication
ANTIMICROBIAL ADVICES DRIVEN
INTERVENTIONS
IV TO ORAL SWITCH GUIDELINE
PRESCRIPTION AUDIT
• Facility level assessment exercise conducted
periodically, for reviewing the facility’s
prescriptions, of which audit of antibiotic
prescription is one of the main component.
• To do this, e-prescription is the best one
• If prescription is done manually, first copy
handed over to the patient, pharmacist retains
second copy and third copy is submitted for
the auditing
PRESCRIPTION AUDIT METHODOLOGY
• It’s not fault finding or blame game exercise
but a fact finding effort.
• It’s not about who went wrong, but on
identifying what went wrong and why did it
happen??
• Done every month in high throughput
facilities and done every three months in low
throughput facilities
PRESCRIPTION AUDIT COMMITTEE
• Hospital in-charge (MS)
• Prescription auditor from AMS team
• One clinician from each department
• In-charge nursing services
• In-charge of hospital pharmacy
PRESCRIPTION AUDIT – DATA
COLLECTION METHOD
• Data collection – Simple random sampling
• Numerator – Patient demographics,
completeness of prescription related
attributes and Antibiotic stewardship related
attributes
• Denominator – Number of samples
ANTIBIOTIC TIME OUTS
• It involves scheduled reassessment of the
choice of antibiotics and need for continuing
the antibiotic, when the clinical picture is
clearer and more diagnostic information
(Eg: culture report) is available
ANTIBIOTIC REVIEW FORM
DOSAGE OPTIMIZATION
• The concept of dosage optimization is needed
to ensure that the appropriate and effective
antimicrobial therapy is administered while
minimizing the possibility of adverse drug
reactions and suboptimal therapy
AUTOMATED ALERTS
Automated alerts integrated with response and
intervention by the AMS team can be a very
effective stewardship strategy.
IT CAN BE EITHER:
• Clinical microbiological alert
• Pharmacy alert
• AMS advice alert
EDUCATIONAL INTERVENTIONS
• It leads to increasing the knowledge,
rationalizing the practice and improving the
attitude is considered as an important and
core persuasive AMS interventions.
• Educational interventions can be carried out
both for clinicians and patients/general public
ADDITIONAL STRATEGIES
LOW HANGING FRUITS
• It refers to the implementation of the most
obtainable targets (Interventions) with limited
resources first rather than confronting more
complicated resource intensive interventions.
EXAMPLES:
• IV to oral conversion
• Batching of IV antimicrobials
• Culture sent before antimicrobial start
START SMART THEN FOCUS STRATEGY
SURGICAL PROPHYLAXIS ALGORITHM
MINDME STRATEGY
• Microbiology guides therapy, wherever
possible
• Indications should be evidence based
• Narrowest spectrum required
• Dosage individualised to the patient
• Minimize the duration of therapy
• Ensure oral therapy is used, where clinically
appropriate
INTERVENTIONS TO CONTROL OTC SALE
PROPERTIES SCHEDULE H SCHEDULE H1
Treatment
PROPERTIES SCHEDULE H DRUGS SCHEDULE H1 DRUGS
Treatment Black colour Red colour
Warning box label Box with black border to be
sold by prescription of
RMP only
Box with red border to be
sold by prescription of
RMP only
(RED LINE CAMPAIGN
INITIATED IN 2016)
Register maintenance Not required Maintained for 3 years
Introduced in 1945 Drug and cosmetic
rules
Revised in 2014
SCHEDULE H1 DRUGS
BACK UP PRESCRIPTION
• A back up (Delayed) prescription is a
prescription (Which can be post dated) given
to a patient or his care giver with the
assumption that it will not be dispensed
immediately, but will be dispensed in a few
days if symptoms worsen.
• We can give it directly to the patient care giver
or local pharmacy
ADDITIONAL STRATEGIES
ROLE OF BEHAVIOURAL CHANGES IN
AMS
BEHAVIOURAL INTERVENTIONS
• AMS requires a range of behaviours such as
following guidelines assessing the benefits
and risks of treatment; choosing the
appropriate drug, route or dose and
administering the antibiotic at the appropriate
time, at the correct frequency and for the
appropriate
FACTORS INFLUENCING PRESCRIBER’S
MINDLINE
MAHATHMA GANDHI ONCE SAID...
• “YOUR BELIEFS BECOME
YOUR THOUGHTS,
YOUR THOUGHTS
BECOME YOUR WORDS,
YOUR WORDS BECOME
YOUR ACTIONS, YOUR
ACTIONS BECOME
YOUR HABITS, YOUR
HABITS BECOME YOUR
VALUES”
MONKEY’S RULE – FIVE MONKEYS
EXPERIMENT
FIXED VS GROWTH MINDSET
BEHAVIOURAL CHANGE TECHNIQUES
• COM-B Model (Capability, Opportunity, Motivation-
Behaviour)
• Theoretical domain framework (TDF)
• WHO tool – Tailoring Antimicrobial Resistance
Programmes (TAP)
• Goal setting and Action planning
• Nudge style intervention (Indirect suggestions to
influence the behaviour)
• Leveraging market forces (Agriculture and Veterinary)
• Self monitoring and feedback (Control theory – High
likelihood of behavioural change occurs if feedback
about one’s performance accompanied by
performance target)
MONITORING OF ANTIMICROBIAL
STEWARDSHIP
TYPES OF MEASUREMENTS IN AMS
• Outcome measures – “Did the process
implemented directly lead to an intended
outcome (Reduction in resistance or
antimicrobial consumption or other
unintended consequences of antimicrobial
use)”
• Process measures – “Whether the
intervention is properly implemented and
resulted in a desired change in the process
factors (Eg: De-escalation) and that leads to an
intended outcome”
DATA SOURCE FOR ANTIMICROBIAL
USAGE
TWO TYPES
• Geographical location specific data source
• Health care facility level data source
DATA SOURCE
GEOGRAPHICAL LOCATION SPECIFIC DATA HEALTH CARE FACILITY LEVEL DATA
Manufacturer level Procurement data
Pharmacies level data Dispensing data
Prescribing records Prescription data
Health insurance data Nursing chart data
Community survey Patient level data
ANTIMICROBIAL CONSUMPTION AND
USE
ANTIMICROBIAL CONSUMPTION (AMC):
• Estimates derived from data, which provides an
overall indirect proxy estimate on the usage of
antimicrobials
• Facility based data
ANTIMICROBIAL USE (AMU)
• Represents the direct estimate of use of
antimicrobials derived from patient level data i.e.
The quantity of antimicrobials the patients have
actually consumed.
First we have to follow AMC...once well
implemented we can move on to AMU
ATC (Anatomical Therapeutic Chemical) CLASSIFICATION SYSTEM
(Most commonly used system to analyse parameters)
Five levels are there.....
LEVEL – 1:
• Anatomical (Pharmacological) main group
• Represented by alphabet
Examples:
J – Antimicrobials of systemic use
A – Intestinal antimicrobials
P – Anti parasitic drugs
ATC (Anatomical Therapeutic Chemical) CLASSIFICATION SYSTEM
(Most commonly used system to analyse parameters)
LEVEL-2:
• Therapeutic (Pharmacological) subgroups
• Represented by numbers
Examples:
J01 – Antibacterial agents of systemic use
J02 – Anti fungal agents
J04 – Anti mycobacterial agents
J05 – Anti viral agents
P02 – Anti helminthic agents
ATC (Anatomical Therapeutic Chemical) CLASSIFICATION SYSTEM
(Most commonly used system to analyse parameters)
LEVEL – 3:
• Pharmacological (Chemical/therapeutic)
subgroups
• Represented by alphabets
Examples:
J01C – Beta lactams
P01B – Anti malarial agent
P02C – Anti nematode agents
ATC (Anatomical Therapeutic Chemical) CLASSIFICATION SYSTEM
(Most commonly used system to analyse parameters)
LEVEL – 4:
• Chemical (Pharmacological/therapeutic)
subgroups
• Represented by alphabets
Examples:
J01CA – Extended spectrum penicillins
P02CA – Benzimidazoles
ATC (Anatomical Therapeutic Chemical) CLASSIFICATION SYSTEM
(Most commonly used system to analyse parameters)
LEVEL – 5:
• Chemical substance (i.e. Actual drug)
• Represented by numbers
Examples:
J01CA01 – Ampicillin
J01CA012 – Amoxycillin
P02CA03 – Albendazole
DEFINED DAILY DOSE (DDD)
• Average maintenance dose per day for a drug
used for its main indication in adults.
• DDD has been assigned only for antimicrobial
agents that have ATC code
• It is a unit of technical measurement used to
measure the drug usage and it does not
necessarily correspond to the recommended
therapeutic dose for prescribed daily dose.
ASSIGNING DDD VALUES
In general – DDD value will be calculated based
on daily dosage regimen
In loading dose & maintenance dose scenario –
DDD will be calculated as follows:
• Duration of therapy >7 days = Maintenance
dose per day
• Duration of therapy ≤7 days = Loading dose +
Average of daily Maintenance dose divided by
duration of treatment
ANTIMICROBIAL CONSUMPTION
QUANTIFIED AS
• Antimicrobial consumption volume
• Antimicrobial consumption density
ANTIMICROBIAL CONSUMPTION
VOLUME
• Calculated by dividing the amount of
antimicrobial agent (measured in grams) by
the DDD value (In grams) that has been
assigned to the respective antimicrobial agent
by the WHO CC
• DDD value (In grams) based on package level
data and Substance level data
DDD CALCULATION FOR
COMBINATION PRODUCTS
• Product with only one active agent (Regular
DDD calculation)
• Product with ≥2 active agents – Unit dose
UNIT DOSE:
• One tablet or vial of a combination product
with specific strength of each component is
defined as unit dose
ANTIMICROBIAL CONSUMPTION
DENSITY
• Antimicrobial consumption will vary
depending on the size of population in the
geographical region, hospital inpatient and
outpatient count.
BASED ON THREE VARIABLES:
• Based on geographical region specific data
• Based on facility specific inpatient data
• Based on facility specific outpatient data
BASED ON FACILITY SPECIFIC INPATIENT DATA
Denominators will be:
• Patient days
• Days present
• Bed days
• Occupied bed days
• Admissions
• Billing days
• Discharges
BASED ON FACILITY SPECIFIC OUTPATIENT DATA
Denominators will be:
• Number of outpatients attended
• Number of outpatients prescriptions
GRANULARITY
• The concept of granularity means that the
more the data is collected in-depth from the
lowest possible data sources, the more
detailed analysis can be performed with the
existing data
DECREASING ORDER OF GRANULARITY
• Dispensing level data
• Procurement level data
• Distribution level data
• District level data
• State level data
• National level data
GRANULARITY OF DATA AT HOSPITAL LEVEL
MAIN DISADVANTAGE OF THIS DDD
MEASUREMENT IS THAT IT WON’T FIT
FOR PEDIATRICS
AMC TOOL
• It is an open source program to calculate
antimicrobial consumption collected as
packages data and converts into numbers of
defined daily doses (DDD) using ATC/DDD
index
• Successor of the old tool called as ‘ABC Calc’
• Manual data entry or imported from CSV
file/Excel file
DAYS OF THERAPY (DOT)
• It is the number of days that patient receives
at least one dose of an antibiotic summed for
each antimicrobial agent.
• Like DDD, It is also having two analysis DOT
consumption volume and density
• Since it’s independent of dosage and
frequency we can use it for pediatrics also
STANDARD ANTIMICROBIAL
ADMINISTRATION RATIO (SAAR)
• It is calculated as the ratio of observed and
predicted antimicrobial use
• If SAAR>1 = Overuse of antimicrobials than
predicted
• If SAAR<1 = Underuse of antimicrobials than
predicted
• If SAAR=1 = Equivalent use of antimicrobials
than predicted
POINT PREVALENCE SURVEY (PPS)
• It is a qualitative indicator of antimicrobial
consumption
• It refers to the collection of antimicrobial
treatment data from hospitalized patients at a
fixed point of time
PRESCRIBED DAILY DOSE (PDD)
• It is defined as the average dose prescribed
according to a representative sample of
prescriptions.
ANTIMICROBIAL FREE DAYS (AFD)
• It is defined as the total number of days when
no antimicrobial agents were administered to
the patient during a single episode of
hospitalization.
PROPORTION OF PATIENTS ON
ANTIMICROBIAL THERAPY
• It is defined as the proportion of patients in a
health care facility receiving antimicrobial
therapy for a given period of time out of total
number of patients attending at facility for the
same time period.
CLINICAL OUTCOME INDICATORS
• Mortality indictors
• Morbidity indicators
MORTALITY INDICATORS
• All in cause hospital mortality
• All in cause 30 day mortality
• Infection specific mortality
• MDRO related mortality
• Standardized mortality ratio
MORBIDITY INDICATORS
• All-cause length of stay in hospital
• Infection specific length of stay in hospital
• Stratified infection specific length of stay in
hospital
• Proportion of patients with clinical failure
• All cause readmission within 30 days
• Infection related readmission within 30 days
• Ward to ICU transfer rate
• Antimicrobial related toxicity rate
MICROBIOLOGICAL OUTCOME
INDICATORS
• Antimicrobial resistance outcome indicator
• Clostridium Difficile Infection (CDI) rate
• HAI rate
FINANCIAL OUTCOME INDIACATORS
• Cost volume
• Cost density
PROCESS MEASURES
Based on compliance to guidelines
• Empirical treatment guidelines
• Targeted treatment guidelines
• Surgical prophylaxis guidelines
• Prescription related process indicators
• Diagnostic related process indicators
• Administrative correctness indicators
Structural and Infection control process indicators
NATIONAL RESPONSE TO AMR IN
INDIA
• 2010 – National task force
• 2011 – National policy for AMR containment
• 2011 – Jaipur declaration on AMR
• 2012 – Chennai declaration to tackle AMR
• 2017 – Delhi declaration
• 2017-2021 = NAP-AMR
• 2022-2026 = NAP-AMR 2.0
GOAL OF NAP-AMR
TO EFFECTIVELY COMBAT AMR IN INDIA
STRATEGIC PRIORITIES OF NAP-AMR
NAP-AMR 2.0 (2022-2026)
• NCDC, Government on India in collaboration with
WHO India and Infectious Diseases Detection and
Surveillance (IDDS) planned a series of sectoral
and intersectoral consultations to obtain inputs
from experts on the status of implementation of
NAP-AMR, challenges and lessons learnt.
• There is proposal came for adding AMC
surveillance in strategic priority 2. (Previously in
strategic priority 4)
STATE ACTION PLAN ON AMR
• Kerala started it first on 2018
• Madhya pradesh in 2019
• Delhi in 2020
SAP in other states (Under process for
implementation)
• Andhra pradesh, Telangana, Tamilnadu,
Maharashtra, Goa, Puducherry, Karnataka
GLOBAL PARTNERS FOR AMR IN INDIA
CDC – India
• HAI surveillance network
• NARS-net (National Antimicrobial Resistance
Surveillance Network)
WHO-India
• CSS (Country cooperation strategy)
• WHONET
• GLASS (Global Antimicrobial Resistance and Use
Surveillance System)
• WINSAR
GLOBAL PARTNERS FOR AMR IN INDIA
• FAO
• USAID (United States Agency for International
Development)
• World bank
• Fleming fund
• ReAct
NATIONAL NETWORKS PARTICIPATION
FOR AMR IN INDIA
• ICMR is taking care of AMR surveillance and
research, HAI surveillance, Antimicrobial
stewardship and infection control
• NCDC – AMR surveillance
• CDC – HAI surveillance
Centres enrolled for National
programme on AMR in Tamilnadu
• Coimbatore medical college
• KAPV Government medical college, Trichy
ICMR PROJECT ON AMS PROGRAM
FIRST PHASE AMSP PROJECT (2018-2021)
• Initiating AMS activities in Hospitals in India
• Successfully implemented in 20 hospitals (12
government sectors and 8 private hospitals)
SECOND PHASE AMSP PROJECT (2022-2025)
• Implementation of AMSP in various tertiary
care hospitals in India based on the results of
phase-1.
ANTIMICROBIAL STEWARDSHIP IN
SPECIAL SITUATIONS
CORE ELEMENTS OF OUTPATIENT AMS
• Commitment
• Action for policy and practice
• Tracking and reporting
• Education and expertise
AMS IN OUTPATIENT PARENTERAL
ANTIMICROBIAL THERAPY (OPAT)
• OPAT – Administration of parenteral antimicrobial
therapy in at least two doses on different days
without intervening hospitalization.
• Core OPAT team – OPAT specialist nurse, Doctor,
ID physician or clinical microbiologist, Pharmacist
• At-least weekly review of OPAT patients, and have
to give training on IV line care along with hand
hygiene, Inspection of insertion of IV line site ....
AMS IN LONG TERM FACILITY CENTRES
(LTCFs)
• LTCFs – They are the centres that provide services
to people (Usually old age) with their medical
needs or daily activities over a long period of
time when they can no longer perform everyday
activities on their own.
• Empower the medical director to set standards
for prescribing antimicrobials for LTCFs patients
• Empower the Nursing superintendent to set the
practice standards of front line staff nurses for
providing care
ONE HEALTH APPROACH IN
INTEGRATED STEWARDSHIP
• Stewardship measures implemented to contain
AMR must address all the interconnected
domains of one health – human, animal and
environment
• Done by FAO-OIE-WHO-UNEP quadripartite
commitment
• Since 2010, It’s tripartite....On 17th march 2022,
UNEP is added (United Nations Environmental
program) as fourth partner
• OIE (Office International des Epizooties)...Now
this is updated to WOAH (World Organization for
Animal Health)
ONE HEALTH HIGH LEVEL EXPERT
PANEL (OHHLEP)
• The advisory panel of OHHLEP whose members
represent a broad range of disciplines in science
and policy related sectors relevant to one health
around the world formulated a new operational
definition called as one health approach.
• One health is defined as an “Integrated, unifying
approach that aims to sustainably balance and
optimize the health of people, animals and
ecosystems
• International One Health Day – November 3rd
every year
ENVIRONMENTAL STEWARDSHIP
SPREAD OF AMR BY EITHER
• Gene transfer (i.e. Mutation from pre existing
genome)
• Horizontal gene transfer (A novel
Antimicrobial Resistance Genes (ARGs) from
environment)
HORIZONTAL GENE TRANSFER
• 1st step – Initiated by the ability of donor
bacterium to move the ARG within the genome
• 2nd step – Relocation of ARG to an element called
as conjugative plasmid, so that ARG can move
freely between cells
• 3rd step – Horizontal transfer of ARG either
directly in environment or through several
bacterial hosts
• 4th step – Physical transfer of bacterium carrying
ARG from environment to the human or domestic
animal microbiota (Ecological connectivity)
ARG TRANSFER MECHANISM....
VETERINARY STEWARDSHIP
• Injudicious use of antimicrobials in animals
increasing the antibiotic resistance.
• Other than therapeutic use, penicillin,
tetracycline, colistin, avoparcin(Glycopeptide),
streptogramin, tylosin (Macrolide) were used
for growth promotion, egg production, milk
production.
COLISTIN BANNED IN INDIA AS AN ANIMAL FEED
NO ANTIBIOTICS..... FOR
VETERINARIES....
• For therapeutic – Vaccination, Immune
modulators, Phage therapy
• For non-therapeutic (Growth promotors) – Pre
and probiotics, Infeed enzymes,
Phytochemicals, Clay minerals.....
FISHERIES STEWARDSHIP
PROGRAMME
• Eventhough the use of antimicrobials inn
fishereies plays a minor role in antimicrobial
resistance, stewardship measures should not be
ignored.
• Mainly used in ponds and tanks
• In ocean (Marine water) calcium and magnesium
ions decrease the biological activity of
oxytetracycline and fluroquinolones by forming
divalent cation complex and it leads to
antimicrobial effect loss within a month......
MEASURES TAKEN IN AGRICULTURAL
STEWARDSHIP
• FAO launched InFarm IT platform in 2022.
• Each country should upload data in POMS
(Plantwise Online management system)
HOSPITAL SOURCE CONTROL – UNMET NEED OF
AN INTEGRATED ANTIMICROBIAL STEWARDSHIP
1) Timely identification of MDR PEAK ME infections
2) Isolation room for that patients
3) Environmental cleaning after shifting that
patient
4) Following correct antimicrobial guidelines
5) Timely de-isolation of the patient
6) Local ground working team to monitor IPC
practices
MAJOR IPC PRACTICES OF SOURCE
CONTROL
• Hand hygiene
• PPE
• Single use of patient dedicated equipment
• Following bundle care approach in CAUTI,
CLABSI, SSI, VAP and Ryle’s tube
• Body care
• HCW vaccination
ANTIBIOGRAM
• Overall profile of antimicrobial susceptibility testing
results of a specific microorganism to a battery of
antimicrobial agents
TYPES:
• Routine cumulative antibiograms
• Enhanced antibiograms (Location/ICU/Population
wise/Age wise)
• Subtraction antibiogram (Comparing with last year)
• Atleast 30 isolates should be available for each
organism to kept ready antibiogram
• Should be done annually (Even six months once /more
frequently if no. of isolates in each organism is more
than 30)
MIC CREEP
• MIC values are not included in antibiogram
• As a result, subtle trends below the resistance
threshold are not reflected
ANTIFUNGAL STEWARDSHIP
• AFS is a component of AMS where
antibacterial drugs are replaced by antifungal
drugs
• AMS team should have mycologist.
• AFS program is yet to start in our country
• Main efforts are made to shift prophylactic
therapy to empirical, empirical to pre-
emptive, pre-emptive to targeted therapy
ANTIVIRAL STEWARDSHIP
• Immunocompromised patients are at
increased risk of acquiring a number of
opportunistic viral infections-the most
common is CMV. (Anti CMV stewardship)
• Anti RSV stewardship
THANK YOU

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ANTIMICROBIAL STEWARDSHIP POWERPOINT.pptx

  • 1. ANTIMICROBIAL STEWARDSHIP DR.P.B.PRAVEENKUMAR SECOND YEAR POST GRADUATE DEPARTMENT OF MICROBIOLOGY THANJAVUR MEDICAL COLLEGE
  • 2. SYNOPSIS • INTRODUCTION OF AMSP • IMPLEMENTATION OF AMSP • MONITORING OF AMSP • CURRENT SCENARIO OF AMR AND ROLE OF AMR SURVEILLANCE • AMS IN SPECIAL SITUATIONS • ONE HEALTH APPROACH • ANTIBIOGRAM • ANTIFUNGAL STEWARDSHIP • ANTIVIRAL STEWARDSHIP
  • 3. ANTIMICROBIAL STEWARDSHIP It is an inter-professional efforts across the continuum of care that involves • Timely and optimal selection, dose and duration of an antimicrobial • For the best clinical outcome for treatment or prevention of infection • With minimal toxicity to the patient • And minimum impact on resistance and other ecological adverse events
  • 4. WHO DEFINITION OF AMS Stewardship – Careful and responsible management of something entrusted to one’s care AMS – Coherent set of actions which promote the responsible use of antimicrobials at individual/national/global level AMS Program – Organization or system wide health care strategy to promote the appropriate use of antimicrobials through the implementation of evidence based interventions
  • 5. CDC DEFINITION OF AMS The use of the right antimicrobial, for the right patient at the right time, with the right dose, route and frequency, causing the least harm to the patient and future patients
  • 6. IDSA DEFINITION OF AMS Co-ordinated interventions designed to improve and measure the appropriate use of antimicrobials by promoting the selection of the optimal antimicrobial drug regimen, dose, duration of therapy and route of administration
  • 7. EIGHT 8Ds OF AMS • Diagnosis • Drug • Dosage • Diagnostics • De-escalation • Duration • Debridement/Drainage • Disease prevention and control measures
  • 8. WHY AMSP IS NEEDED? • To prevent antimicrobial resistance • Misuse and overuse of antimicrobial agents • Use of antimicrobials in other sectors • Poor antimicrobial research
  • 10. ANTIMICROBIAL USAGE IN OTHER SECTORS
  • 11. ANTIMICROBIAL PRESCRIPTION 30% RULE • 30% of hospitalized patients at any given time receive antimicrobial agents • 30% of antimicrobials prescribed inappropriately in the community • Up to 30% of surgical prophylaxis is inappropriate • 30% of hospital pharmacy costs are due to antimicrobial use • 10-30% pharmacy costs can be saved by antimicrobial stewardship programs
  • 12. GOALS OF AMS • Reduce antimicrobial resistance • Improve patient outcomes • Improve patient safety through minimizing unintended consequences of antimicrobials • Reduce health care cost towards antimicrobial drugs without affecting quality
  • 13. AID INTEGRATED STEWARDSHIP MODEL • Antimicrobial stewardship • Infection control stewardship program • Diagnostic stewardship
  • 14. PYRAMID PLATFORM TO ILLUSTRATE AID MODEL
  • 15. DIAGNOSTIC STEWARDSHIP Three components • Ordering the right test • Performing the test by the right method • Communicating the results within the right time
  • 16. AWARE CLASSIFICATION- PURPOSE OF THIS CLASSIFICATION • To monitor antimicrobial consumption • Defining targets and monitoring effects of the antimicrobial stewardship policies
  • 17. GOAL OF AWARE CLASSIFICATION By the end of 2023, WHO aims country level target of at-least 60% of total antimicrobial consumption from Access group & less than 40% from watch and reserve group
  • 18. THREE GROUPS • Access (87 drugs as per 2021 update) – 21* • Watch (141 drugs as per 2021 update) – 12* • Reserve (29 drugs as per 2021 update) – 8* NOTE: Each group is having one division called as ESSENTIAL MEDICINES (EML) for empirical treatment (* )- WHO EML list
  • 19. ACCESS GROUP • Includes antimicrobials that have activity against a wide range of community encountered susceptible pathogens while also showing lower resistance potential than antimicrobials in other group.
  • 20. ACCESS GROUP (EML LIST)-21 DRUGS • Benzyl penicillin • Benzathine benzyl penicillin • Phenoxymethyl penicillin • Ampicillin • Amoxicillin • Amoxicillin-clavulanate • Cefalexin • Cefazolin • Cloxacillin •Gentamicin •Amikacin •Spectinomycin •Doxycycline •Cotrimoxazole •Chloramphenicol •Nitrofurantoin •Clindamycin •Metronidazole (IV) •Metronidazole (Oral)
  • 21. WATCH GROUP • Includes antimicrobials that have higher resistance potential and includes most of the highest priority agents among the critically important antimicrobials for human medicine • Antimicrobials in WATCH group should be prioritized as key targets for stewardship programme.
  • 22. WATCH GROUP (EML LIST)-12 DRUGS • Cefuroxime • Cefotaxime • Ceftriaxone • Ceftazidime • Cefixime • Ciprofloxacin • Azithromycin • Clarithromycin • Piperacillin tazobactam • Meropenem • Vancomycin (IV) • Vancomycin (Oral)
  • 23. RESERVE GROUP • Includes antimicrobials and agents that should be reserved for treatment of confirmed or suspected infections due to MDRO • Considered as LAST RESORT when every other alternatives failed. • These drugs could be protected and prioritized as key targets of antimicrobial stewardship programme and monitoring.
  • 24. RESERVE GROUP (EML LIST)-8 DRUGS • Ceftazidime-avibactam • Meropenem-vaborbactam • Colistin • Polymyxin B • Fosfomycin • Linezolid • Cefiderocol • Plazomicin
  • 25. BARRIERS IN IMPLEMENTATION OF AMSP • Clinician knowledge deficit on usage of antimicrobials and opposition from their side • Limited access of antimicrobials • Fear of poor outcome by withholding antimicrobials • Lack of communication among health care workers • Limited public/patient acceptance of AMSP • OTC sales of antimicrobial drugs
  • 26. IMPLEMENTATION OF AMSP CORE ELEMENTS OF AMS PROGRAM • WHO Check list • CDC Check list
  • 27. CORE ELEMENTS – WHO CHECK LIST • NAP (National Action Plan) on AMR states that AMS is a national priority • Dedicate funding for national action plan on AMR • Technical working group on AMS • Defined goals, outcomes, timelines and structures has been developed • Monitoring and evaluation mechanism for NAP on AMR
  • 28. CORE ELEMENTS – WHO CHECK LIST (cont.) • Integration of AWARE classification of antibiotics with WHO essential medicines list • Up to date clinical guidelines includes AMS principles and integrate with AWARE antibiotics • Regulations of fixed dose combinations of drugs • Regulations on prescription only sales of antibiotics • Ensure continued availability of quality assured antibiotics • Ensure affordability of essential antibiotics
  • 29. CORE ELEMENTS – WHO CHECK LIST (cont.) • Public antibiotic awareness campaigns • Education in schools on basic infection control principles • Training on AMS competencies for AMS team members • Education and training given to health care workers • Incentives to support AMSP implementation
  • 30. CORE ELEMENTS – WHO CHECK LIST (cont.) • National surveillance system on antimicrobial consumption • National surveillance system on AMR in place with laboratory capacity • Diagnostic tests are available and capacity building are undertaken to optimise antimicrobial use
  • 31. CDC CORE ELEMENTS CHECK LIST
  • 32. STEPS OF IMPLEMENTATION OF AMS PROGRAM IN A HOSPITAL • Administrative support (Leadership) • Set up AMS committee and AMS team • Multi disciplinary support • Framing antimicrobial policy • Implementing stewardship strategies • Education and training
  • 33. AMS COMMITTEE TYPES • Stand alone type (Preferable) • Integrated type (Saves time)
  • 34. AMS COMMITTEE MEMBERS • Health care facility leadership (Medical director/Medical superintendent) – CHAIR PERSON • AMS team members • HODs of various departments including microbiology and pharmacology in particular • In-charges of intensive care units • Nursing superintendent • AMS Steward – Member secretary
  • 35. AMS COMMITTEE (cont.) • Meeting not less than once in three months • At-least a week prior notice via mail or letter to all departments • On that particular day reminder is must • Presentation on AMR current trend in our hospital • Review of last meeting • The minutes of meeting should be documented
  • 36. CORE MEMBERS OF MULTI DISCIPLINARY AMS TEAM • Infectious diseases physician (FIRST CHOICE) • Infection control officer • Clinical microbiologist • Internal medicine physician • Clinical pharmacists with infectious disease training • AMS nurses with infectious diseases training • Officer in charge of pharmacy • Clinical pharmacologist
  • 37. ANTIBIOTIC STEWARD QUALITIES • He/she is the central driving force behind this program • Having skills like communication, teamwork • Ability to influence others • Commands the respect of peers • Inspires trust with all stakeholders • Motivates the team • Possesses the long range perspective • Creates and recognises opportunity
  • 38. ANTIBIOTIC STEWARD QUALITIES • Influence prescriber’s decision making • Clinical expertise • Antimicrobial expertise • Microbiological expertise • IPC Expertise
  • 39. ID PHYSICIAN • First choice to lead AMS team DISADVANTAGES • Paucity of ID physicians in India • Lack of vacant posts in government sectors • Lack of time allotment to do stewardship work
  • 40. ID COURSES (NMC AND DNB RECOGNIZED)
  • 41. INFECTION CONTROL OFFICER • Mostly ICO will be clinical microbiologist since they are expert in infection control stewardship DISADVANTAGES • Insufficient clinical expertise • Limited knowledge of treatment guidelines and antimicrobial drugs • But at the same time if ICO is from non- microbiological background then diagnostic stewardship will be big challenge
  • 42. INTERNAL MEDICINE PHYSICIAN • Much better than ID physician • Having through clinical knowledge • More familiar with clinical work practice and ward rounds DISADVANTAGES: • Limited and suboptimal knowledge on diagnostic and infection control stewardship
  • 43. CLINICAL PHARMACIST • Well fit for western countries ROLE: • Prescription audit • Separate rounds in ward and then rounds with AMS steward to save the time for AMS steward • Pharmacokinetic monitoring • Drug allergy monitoring • Discharge advisory for the patients • Educating the patients and other health care workers
  • 44. HAND SHAKE STEWARDSHIP In 2019, CDC introduces hand shake stewardship with pharmacists and physicians for effective implementation of AMSP in hospital
  • 45. LIMITATIONS OF CLINICAL PHARMACIST • Lack infection control and microbiological expertise • Lacks clinical knowledge • Paucity of ID trained clinical pharmacists in India
  • 46. STEWARDSHIP NURSES • Advantages are availability of nurses is high, Sufficient IPC knowledge, Familiar with hospital work flow ROLE: • Ensure collection of proper samples • Keeping track on laboratory reports • To keep a check on administrative errors (Dose, route of administration) • Educating the patient • AMS audit
  • 47. OFFICE INCHARGE OF PHARMACY • Member should be from pharmacology department (Faculty) • List of antimicrobial agents available • Quality assurance • Formulary restriction • Pre authorization for restricted drugs • Automatic stop order
  • 48. CLINICAL PHARMACOLOGIST • Contributing formulation of antimicrobial policy • Therapeutic drug monitoring • Training of pharmacists • Look for drug-drug interactions, adverse effects and pharmacovigilance
  • 49. MULTI DISCIPILINARY SUPPORT • Support from microbiology laboratory • Support from pharmacology laboratory • Support from HICP unit • Link between IPC and AMS • Support from IT wing • Role of individual stake holders in AMSP
  • 50. LINK BETWEEN IPC AND AMS
  • 51. “GUIDELINE NOT MINDLINE” • Physicians should strictly adhere to the guidelines for rationalizing the antibiotic use rather following mind lines (View of peer or senior physicians or local practice or pressure from medical representatives)
  • 52. FRAMING ANTIMICROBIAL POLICY It includes • Title page • Goal of AMSP • List of available antimicrobials • General guidelines • Antibiogram data of last year • Treatment regimen for system wise All guidelines based on IDSA, Sanford’s guide, ICMR, NCDC, Mandell, Doughlas and Bennett’s principles and Harrison’s Principles of Internal Medicine
  • 53. ROLE OF INFORMATION TECHNOLOGY IN AMS • By providing clinical decision support system (CDSS) • Recording and facilitating the informational workflow • By helping implementation and monitoring of AMS interventions
  • 54. HEALTH CARE IT SERVICES • Hospital information system (HIS) • Laboratory information system (LIS) • Electronic Medical record (EMR) • Electronic Health record (EHR) • Ayushman Bharat Digital Mission – ABHA number • Personal Health records (PHR)
  • 55. BENEFITS OF LIS • Data entry • Tracing of reports • No risk of losing data • Statistics • Online access to reports • Critical alerts • Bidirectional communication between laboratory and wards
  • 56. ABHA NUMBER AND IT’S BENEFITS The citizens need to create an Ayushman Bharat Health Account (ABHA) number by linking to unique identifier such as Aadhar card • Unique and trustable identity • Unified benefits • Hassle free access • Easy PHR sign up
  • 57. CDSS (COMPUTERIZED DECISION SUPPORT SYSTEMS) • Defined as computer applications designed to aid clinicians in making diagnostic and therapeutic decisions in patient care and thereby improving antimicrobial use
  • 58. CDSS AT PHYSICIAN LEVEL RESTRICTIVE APPROACH: • Physicians can use this platform for usage of restricted and semi-restricted drugs PERSUASIVE APPROACH: • Includes clinical practice, treatment algorithm, antimicrobial policy, local antibiogram
  • 59. CDSS AT AMS TEAM LEVEL POST PRESCRIPTION REVIEW: • Incorporating data from multiple systems such as microbiology, pharmacy CONSUMPTION AUDIT: • To monitor and measure the impact of AMSP program.
  • 60. TYPES OF ANTIMICROBIAL CDSSs 1. SIMPLE CDSS 2. COMPLEX CDSS • Electronic guidelines and mobile applications • Electronic antimicrobial approval systems • Electronic infection prevention control and surveillance systems • EPS and EMM systems (Electronic prescribing system and Electronic medication management) • Clinical microbiology decision support systems • Advanced decision support systems
  • 61. ELECTRONIC GUIDE AND MOBILE APPLICATIONS MOBILE BASED APPLICATIONS DEVELOPED BY Sanford guide online Sanford Guide, USA John Hopkin Antibiotic guide John Hopkins, medicine, USA EMRA antibiotic guide Emergency medicines residents association, USA Microguide Horizon strategic partners, UK AIIMS antibiotic policy AIIMS, Delhi ICMR treatment guidelines for antimicrobials in common syndromes ICMR, India UptoDate Online Provide various information about infectious diseases MedScape
  • 62. ELECTRONIC IPC AND SURVEILLANCE SYSTEMS • Safety surveillor and Theradoc systems, Premium Healthcare, North carolina • MedMined CareFusion, BD, New Jersey • Sentri7, Wolters Kluwer • RL solutions RL, Canada • Ibhar IPC module, JIPMER, India (IPC module, CMR module, AMS module)
  • 63. INTERVENTION OF AMSP Front end strategy (Restrictive strategy) • Intervention applied actively on prescribers usually before (Sometimes after) prescribing antimicrobials Back end strategy (Persuasive/passive strategy) • Intervention applied passively on clinicians usually after (Sometimes before) prescribing antimicrobials Additional strategy (Resource driven & Guideline based interventions)
  • 64. FRONT END STRATEGY • Formulary restriction with preauthorization • Antibiotic cycling • Antibiotic mixing • Automatic stop orders • Computer physician order entry • Selective susceptibility reporting from the lab
  • 65. FORMULARY RESTRICTION WITH PREAUTHORIZATION Formulary restriction: • Restricting dispensing of targeted antimicrobials on the hospital’s formulary (Pharmacy) according to certain predefined approved criteria Preauthorization: • Authorization of the targeted antimicrobials by the AMS team is needed to procure them from the hospital formulary ONLY DISADVANTAGE FOR FRP IS THAT THIS WILL BE APPLICABLE ONLY WHEN PRESCRIBERS USING E-PRESCRIPTION.
  • 66. IMPORTANT POINTS ABOUT FRP • Deciding the antimicrobials based on local AMR pattern, speciality, suspected clinical diagnosis. • We can adapt WHO AWARE classification for FRP strategy (Unrestricted, semi-restricted, restricted drugs) • Pre-authorization (Compulsory order form) to be filled by prescribers • 24*7 (Round O’ Clock) duties for AMS team to give approval
  • 68. ANTIBIOTIC CYCLING • Withdrawal of an antimicrobial agent or antimicrobial class from general use (Within a ward or institution) for a designated period of time and it’s substitution with antimicrobial agent from different class having a comparable spectrum of activity, but for which organism may have different resistance mechanisms.
  • 69. ANTIBIOTIC MIXING • Consecutive patients with same diagnosis receive an antibiotic from a different class in rotation
  • 70. AUTOMATIC STOP ORDERS • To encourage the prescribers to routinely review the antimicrobial prescriptions for their appropriateness • Usually performed by AMS team and pharmacy
  • 71. ANTIMICROBIAL SUPPRESSION • Withholding (Not releasing) the antimicrobial susceptibility test (AST) results of certain antimicrobial agents from the final patient report. (NOT IN ROUTINE ANTIBIOGRAM) • Purpose: To encourage appropriate use of antimicrobial agents. • Antimicrobial suppression will be done by THREE METHODS.
  • 72. THREE METHODS OF ANTIMICROBIAL SUPPRESSION • Selective reporting • Cascade reporting • Testing limitation
  • 73. SELECTIVE REPORTING Reporting results for specific antimicrobial agents while suppressing others based on some criteria • Organism identification • Mechanism of resistance • Body site • Clinical setting • Patient demographics • Aberrant results • Unavailability of clinical breakpoints
  • 74. ORGANISM IDENTIFICATION CLINICALLY INEFFECTIVE CLINICALLY NOT REPORTED Drugs may display susceptible results in in vitro but clinically ineffective. Example: 1st or 2nd generation cephalosporins and aminoglycosides for salmonella infections Drugs which are effective against organism but no break points available. So not reported. Example: Cefepime, Piperacillin tazobactam, meropenem, imipenem, ertapenem effective against salmonella, but not reported since no breakpoints given by CLSI
  • 75. MECHANISM OF RESISTANCE • No need to modify the AST reports even if any organism is found to be ESBL / AmpC producing.
  • 76. BODY SITE No..ssssss in AST report Respiratory specimen – Daptomycin CSF – 1st,2nd generation cephalosporins, erta/doro/imipenem, clindamycin, tetracycline, macrolides, quinolones, aminoglycosies Urine specimen – Chloramphenicol, macrolides, clindamycin Non urine specimens – Ciprofloxacin, levofloxacin, nitrofurantoin, norfloxacin, nalidixic acid
  • 77. CLINICAL SETTING • IV drugs – OPD setting C/S report • Impaired RFT patients – Aminoglycosides, colistin, vancomycin
  • 78. PATIENT DEMOGRAPHICS • Suppress antibiotics with known adverse effect. Example: Ciprofloxacin, chloramphenicol & tetracycline supressed from pediatric case reports
  • 79. ABERRANT RESULTS • First line drugs are susceptible, second line drugs are resistant. So, here suppress the second line drug status. Example: Ceftriaxone – S Meropenem - R
  • 80. UNAVAILABILITY OF BREAKPOINT • Don’t report that particular drug if breakpoint is not available. EVEN DON’T ADMIT IT IN ANTIBIOGRAM POLICY
  • 81. CASCADE REPORTING • Reporting of AST results involves reporting of broader spectrum/costlier/second line drugs only when narrow spectrum/cheaper/first line drugs are found to be not susceptible
  • 82. THINGS TO BE REMEMBER WHILE CASCADE REPORTING • Pharmacy availability of drug • Local antimicrobial resistance • Clinical consensus and patient status • Following standard guidelines like CLSI or EUCAST • Cascade reporting not cascade testing • Inclusion into antibiogram (Except BP not available)
  • 83. BACK END STRATEGY • Audit and feedback • Pathogen directed AMS audit • Antimicrobial advices driven interventions • Prescription audit • Antibiotic time outs/Review/Self revision • Dosage optimization • Automatic alerts • Behaviour change • Educational intervention
  • 84. AUDIT AND FEEDBACK • Assessment of prescribed antimicrobial treatment, subsequently providing feedback on inappropriate antibiotic prescription to the clinical team TYPES: • Prospective (Real time) audit with feedback (Preferable) • Retrospective Audit with feedback
  • 85. PROSPECTIVE VS RETROSPECTIVE PROSPECTIVE RETROSPECTIVE Audit is conducted in real time Audit is conducted retrospectively Feedback is provided in real time, so that clinicians will ask doubts and get clarified It doesn’t happen Feedback on individual patient prescription provided Overall feedback on antimicrobial use of the location is provided Opportunity to modify individual patient prescription No opportunity to modify Opportunity to educate and training of the clinical team No opportunity for that More time stringent since it’s real time audit Greater flexibility in timing to conduct the audit
  • 86. AUDIT AND FEEDBACK (Stage wise approach) • One stage approach – AMS team rounds along with clinical team • Two stage approach – Clinical pharmacist ID trained, Infection control nurse rounds first and then rounds with clinical team, ID physician & Clinical microbiologist
  • 87. PATHOGEN DIRECTED AMS AUDIT (PD AMS AUDIT) • It is a modification of prospective audit and feedback in which the audit is conducted prospectively for the patients with culture proven infections by telephonic/Bedside/Written communication
  • 89. IV TO ORAL SWITCH GUIDELINE
  • 90. PRESCRIPTION AUDIT • Facility level assessment exercise conducted periodically, for reviewing the facility’s prescriptions, of which audit of antibiotic prescription is one of the main component. • To do this, e-prescription is the best one • If prescription is done manually, first copy handed over to the patient, pharmacist retains second copy and third copy is submitted for the auditing
  • 91. PRESCRIPTION AUDIT METHODOLOGY • It’s not fault finding or blame game exercise but a fact finding effort. • It’s not about who went wrong, but on identifying what went wrong and why did it happen?? • Done every month in high throughput facilities and done every three months in low throughput facilities
  • 92. PRESCRIPTION AUDIT COMMITTEE • Hospital in-charge (MS) • Prescription auditor from AMS team • One clinician from each department • In-charge nursing services • In-charge of hospital pharmacy
  • 93. PRESCRIPTION AUDIT – DATA COLLECTION METHOD • Data collection – Simple random sampling • Numerator – Patient demographics, completeness of prescription related attributes and Antibiotic stewardship related attributes • Denominator – Number of samples
  • 94. ANTIBIOTIC TIME OUTS • It involves scheduled reassessment of the choice of antibiotics and need for continuing the antibiotic, when the clinical picture is clearer and more diagnostic information (Eg: culture report) is available
  • 96. DOSAGE OPTIMIZATION • The concept of dosage optimization is needed to ensure that the appropriate and effective antimicrobial therapy is administered while minimizing the possibility of adverse drug reactions and suboptimal therapy
  • 97. AUTOMATED ALERTS Automated alerts integrated with response and intervention by the AMS team can be a very effective stewardship strategy. IT CAN BE EITHER: • Clinical microbiological alert • Pharmacy alert • AMS advice alert
  • 98. EDUCATIONAL INTERVENTIONS • It leads to increasing the knowledge, rationalizing the practice and improving the attitude is considered as an important and core persuasive AMS interventions. • Educational interventions can be carried out both for clinicians and patients/general public
  • 100. LOW HANGING FRUITS • It refers to the implementation of the most obtainable targets (Interventions) with limited resources first rather than confronting more complicated resource intensive interventions. EXAMPLES: • IV to oral conversion • Batching of IV antimicrobials • Culture sent before antimicrobial start
  • 101. START SMART THEN FOCUS STRATEGY
  • 103. MINDME STRATEGY • Microbiology guides therapy, wherever possible • Indications should be evidence based • Narrowest spectrum required • Dosage individualised to the patient • Minimize the duration of therapy • Ensure oral therapy is used, where clinically appropriate
  • 104. INTERVENTIONS TO CONTROL OTC SALE PROPERTIES SCHEDULE H SCHEDULE H1 Treatment PROPERTIES SCHEDULE H DRUGS SCHEDULE H1 DRUGS Treatment Black colour Red colour Warning box label Box with black border to be sold by prescription of RMP only Box with red border to be sold by prescription of RMP only (RED LINE CAMPAIGN INITIATED IN 2016) Register maintenance Not required Maintained for 3 years Introduced in 1945 Drug and cosmetic rules Revised in 2014
  • 106. BACK UP PRESCRIPTION • A back up (Delayed) prescription is a prescription (Which can be post dated) given to a patient or his care giver with the assumption that it will not be dispensed immediately, but will be dispensed in a few days if symptoms worsen. • We can give it directly to the patient care giver or local pharmacy
  • 108. ROLE OF BEHAVIOURAL CHANGES IN AMS
  • 109. BEHAVIOURAL INTERVENTIONS • AMS requires a range of behaviours such as following guidelines assessing the benefits and risks of treatment; choosing the appropriate drug, route or dose and administering the antibiotic at the appropriate time, at the correct frequency and for the appropriate
  • 111. MAHATHMA GANDHI ONCE SAID... • “YOUR BELIEFS BECOME YOUR THOUGHTS, YOUR THOUGHTS BECOME YOUR WORDS, YOUR WORDS BECOME YOUR ACTIONS, YOUR ACTIONS BECOME YOUR HABITS, YOUR HABITS BECOME YOUR VALUES”
  • 112. MONKEY’S RULE – FIVE MONKEYS EXPERIMENT
  • 113. FIXED VS GROWTH MINDSET
  • 114. BEHAVIOURAL CHANGE TECHNIQUES • COM-B Model (Capability, Opportunity, Motivation- Behaviour) • Theoretical domain framework (TDF) • WHO tool – Tailoring Antimicrobial Resistance Programmes (TAP) • Goal setting and Action planning • Nudge style intervention (Indirect suggestions to influence the behaviour) • Leveraging market forces (Agriculture and Veterinary) • Self monitoring and feedback (Control theory – High likelihood of behavioural change occurs if feedback about one’s performance accompanied by performance target)
  • 116. TYPES OF MEASUREMENTS IN AMS • Outcome measures – “Did the process implemented directly lead to an intended outcome (Reduction in resistance or antimicrobial consumption or other unintended consequences of antimicrobial use)” • Process measures – “Whether the intervention is properly implemented and resulted in a desired change in the process factors (Eg: De-escalation) and that leads to an intended outcome”
  • 117. DATA SOURCE FOR ANTIMICROBIAL USAGE TWO TYPES • Geographical location specific data source • Health care facility level data source
  • 118. DATA SOURCE GEOGRAPHICAL LOCATION SPECIFIC DATA HEALTH CARE FACILITY LEVEL DATA Manufacturer level Procurement data Pharmacies level data Dispensing data Prescribing records Prescription data Health insurance data Nursing chart data Community survey Patient level data
  • 119. ANTIMICROBIAL CONSUMPTION AND USE ANTIMICROBIAL CONSUMPTION (AMC): • Estimates derived from data, which provides an overall indirect proxy estimate on the usage of antimicrobials • Facility based data ANTIMICROBIAL USE (AMU) • Represents the direct estimate of use of antimicrobials derived from patient level data i.e. The quantity of antimicrobials the patients have actually consumed. First we have to follow AMC...once well implemented we can move on to AMU
  • 120. ATC (Anatomical Therapeutic Chemical) CLASSIFICATION SYSTEM (Most commonly used system to analyse parameters) Five levels are there..... LEVEL – 1: • Anatomical (Pharmacological) main group • Represented by alphabet Examples: J – Antimicrobials of systemic use A – Intestinal antimicrobials P – Anti parasitic drugs
  • 121. ATC (Anatomical Therapeutic Chemical) CLASSIFICATION SYSTEM (Most commonly used system to analyse parameters) LEVEL-2: • Therapeutic (Pharmacological) subgroups • Represented by numbers Examples: J01 – Antibacterial agents of systemic use J02 – Anti fungal agents J04 – Anti mycobacterial agents J05 – Anti viral agents P02 – Anti helminthic agents
  • 122. ATC (Anatomical Therapeutic Chemical) CLASSIFICATION SYSTEM (Most commonly used system to analyse parameters) LEVEL – 3: • Pharmacological (Chemical/therapeutic) subgroups • Represented by alphabets Examples: J01C – Beta lactams P01B – Anti malarial agent P02C – Anti nematode agents
  • 123. ATC (Anatomical Therapeutic Chemical) CLASSIFICATION SYSTEM (Most commonly used system to analyse parameters) LEVEL – 4: • Chemical (Pharmacological/therapeutic) subgroups • Represented by alphabets Examples: J01CA – Extended spectrum penicillins P02CA – Benzimidazoles
  • 124. ATC (Anatomical Therapeutic Chemical) CLASSIFICATION SYSTEM (Most commonly used system to analyse parameters) LEVEL – 5: • Chemical substance (i.e. Actual drug) • Represented by numbers Examples: J01CA01 – Ampicillin J01CA012 – Amoxycillin P02CA03 – Albendazole
  • 125. DEFINED DAILY DOSE (DDD) • Average maintenance dose per day for a drug used for its main indication in adults. • DDD has been assigned only for antimicrobial agents that have ATC code • It is a unit of technical measurement used to measure the drug usage and it does not necessarily correspond to the recommended therapeutic dose for prescribed daily dose.
  • 126. ASSIGNING DDD VALUES In general – DDD value will be calculated based on daily dosage regimen In loading dose & maintenance dose scenario – DDD will be calculated as follows: • Duration of therapy >7 days = Maintenance dose per day • Duration of therapy ≤7 days = Loading dose + Average of daily Maintenance dose divided by duration of treatment
  • 127. ANTIMICROBIAL CONSUMPTION QUANTIFIED AS • Antimicrobial consumption volume • Antimicrobial consumption density
  • 128. ANTIMICROBIAL CONSUMPTION VOLUME • Calculated by dividing the amount of antimicrobial agent (measured in grams) by the DDD value (In grams) that has been assigned to the respective antimicrobial agent by the WHO CC • DDD value (In grams) based on package level data and Substance level data
  • 129. DDD CALCULATION FOR COMBINATION PRODUCTS • Product with only one active agent (Regular DDD calculation) • Product with ≥2 active agents – Unit dose UNIT DOSE: • One tablet or vial of a combination product with specific strength of each component is defined as unit dose
  • 130. ANTIMICROBIAL CONSUMPTION DENSITY • Antimicrobial consumption will vary depending on the size of population in the geographical region, hospital inpatient and outpatient count. BASED ON THREE VARIABLES: • Based on geographical region specific data • Based on facility specific inpatient data • Based on facility specific outpatient data
  • 131. BASED ON FACILITY SPECIFIC INPATIENT DATA Denominators will be: • Patient days • Days present • Bed days • Occupied bed days • Admissions • Billing days • Discharges
  • 132. BASED ON FACILITY SPECIFIC OUTPATIENT DATA Denominators will be: • Number of outpatients attended • Number of outpatients prescriptions
  • 133. GRANULARITY • The concept of granularity means that the more the data is collected in-depth from the lowest possible data sources, the more detailed analysis can be performed with the existing data
  • 134. DECREASING ORDER OF GRANULARITY • Dispensing level data • Procurement level data • Distribution level data • District level data • State level data • National level data
  • 135. GRANULARITY OF DATA AT HOSPITAL LEVEL
  • 136. MAIN DISADVANTAGE OF THIS DDD MEASUREMENT IS THAT IT WON’T FIT FOR PEDIATRICS
  • 137. AMC TOOL • It is an open source program to calculate antimicrobial consumption collected as packages data and converts into numbers of defined daily doses (DDD) using ATC/DDD index • Successor of the old tool called as ‘ABC Calc’ • Manual data entry or imported from CSV file/Excel file
  • 138. DAYS OF THERAPY (DOT) • It is the number of days that patient receives at least one dose of an antibiotic summed for each antimicrobial agent. • Like DDD, It is also having two analysis DOT consumption volume and density • Since it’s independent of dosage and frequency we can use it for pediatrics also
  • 139. STANDARD ANTIMICROBIAL ADMINISTRATION RATIO (SAAR) • It is calculated as the ratio of observed and predicted antimicrobial use • If SAAR>1 = Overuse of antimicrobials than predicted • If SAAR<1 = Underuse of antimicrobials than predicted • If SAAR=1 = Equivalent use of antimicrobials than predicted
  • 140. POINT PREVALENCE SURVEY (PPS) • It is a qualitative indicator of antimicrobial consumption • It refers to the collection of antimicrobial treatment data from hospitalized patients at a fixed point of time
  • 141. PRESCRIBED DAILY DOSE (PDD) • It is defined as the average dose prescribed according to a representative sample of prescriptions.
  • 142. ANTIMICROBIAL FREE DAYS (AFD) • It is defined as the total number of days when no antimicrobial agents were administered to the patient during a single episode of hospitalization.
  • 143. PROPORTION OF PATIENTS ON ANTIMICROBIAL THERAPY • It is defined as the proportion of patients in a health care facility receiving antimicrobial therapy for a given period of time out of total number of patients attending at facility for the same time period.
  • 144. CLINICAL OUTCOME INDICATORS • Mortality indictors • Morbidity indicators
  • 145. MORTALITY INDICATORS • All in cause hospital mortality • All in cause 30 day mortality • Infection specific mortality • MDRO related mortality • Standardized mortality ratio
  • 146. MORBIDITY INDICATORS • All-cause length of stay in hospital • Infection specific length of stay in hospital • Stratified infection specific length of stay in hospital • Proportion of patients with clinical failure • All cause readmission within 30 days • Infection related readmission within 30 days • Ward to ICU transfer rate • Antimicrobial related toxicity rate
  • 147. MICROBIOLOGICAL OUTCOME INDICATORS • Antimicrobial resistance outcome indicator • Clostridium Difficile Infection (CDI) rate • HAI rate
  • 148. FINANCIAL OUTCOME INDIACATORS • Cost volume • Cost density
  • 149. PROCESS MEASURES Based on compliance to guidelines • Empirical treatment guidelines • Targeted treatment guidelines • Surgical prophylaxis guidelines • Prescription related process indicators • Diagnostic related process indicators • Administrative correctness indicators Structural and Infection control process indicators
  • 150. NATIONAL RESPONSE TO AMR IN INDIA • 2010 – National task force • 2011 – National policy for AMR containment • 2011 – Jaipur declaration on AMR • 2012 – Chennai declaration to tackle AMR • 2017 – Delhi declaration • 2017-2021 = NAP-AMR • 2022-2026 = NAP-AMR 2.0
  • 151. GOAL OF NAP-AMR TO EFFECTIVELY COMBAT AMR IN INDIA
  • 153. NAP-AMR 2.0 (2022-2026) • NCDC, Government on India in collaboration with WHO India and Infectious Diseases Detection and Surveillance (IDDS) planned a series of sectoral and intersectoral consultations to obtain inputs from experts on the status of implementation of NAP-AMR, challenges and lessons learnt. • There is proposal came for adding AMC surveillance in strategic priority 2. (Previously in strategic priority 4)
  • 154. STATE ACTION PLAN ON AMR • Kerala started it first on 2018 • Madhya pradesh in 2019 • Delhi in 2020 SAP in other states (Under process for implementation) • Andhra pradesh, Telangana, Tamilnadu, Maharashtra, Goa, Puducherry, Karnataka
  • 155. GLOBAL PARTNERS FOR AMR IN INDIA CDC – India • HAI surveillance network • NARS-net (National Antimicrobial Resistance Surveillance Network) WHO-India • CSS (Country cooperation strategy) • WHONET • GLASS (Global Antimicrobial Resistance and Use Surveillance System) • WINSAR
  • 156. GLOBAL PARTNERS FOR AMR IN INDIA • FAO • USAID (United States Agency for International Development) • World bank • Fleming fund • ReAct
  • 157. NATIONAL NETWORKS PARTICIPATION FOR AMR IN INDIA • ICMR is taking care of AMR surveillance and research, HAI surveillance, Antimicrobial stewardship and infection control • NCDC – AMR surveillance • CDC – HAI surveillance
  • 158. Centres enrolled for National programme on AMR in Tamilnadu • Coimbatore medical college • KAPV Government medical college, Trichy
  • 159. ICMR PROJECT ON AMS PROGRAM FIRST PHASE AMSP PROJECT (2018-2021) • Initiating AMS activities in Hospitals in India • Successfully implemented in 20 hospitals (12 government sectors and 8 private hospitals) SECOND PHASE AMSP PROJECT (2022-2025) • Implementation of AMSP in various tertiary care hospitals in India based on the results of phase-1.
  • 161. CORE ELEMENTS OF OUTPATIENT AMS • Commitment • Action for policy and practice • Tracking and reporting • Education and expertise
  • 162. AMS IN OUTPATIENT PARENTERAL ANTIMICROBIAL THERAPY (OPAT) • OPAT – Administration of parenteral antimicrobial therapy in at least two doses on different days without intervening hospitalization. • Core OPAT team – OPAT specialist nurse, Doctor, ID physician or clinical microbiologist, Pharmacist • At-least weekly review of OPAT patients, and have to give training on IV line care along with hand hygiene, Inspection of insertion of IV line site ....
  • 163. AMS IN LONG TERM FACILITY CENTRES (LTCFs) • LTCFs – They are the centres that provide services to people (Usually old age) with their medical needs or daily activities over a long period of time when they can no longer perform everyday activities on their own. • Empower the medical director to set standards for prescribing antimicrobials for LTCFs patients • Empower the Nursing superintendent to set the practice standards of front line staff nurses for providing care
  • 164. ONE HEALTH APPROACH IN INTEGRATED STEWARDSHIP • Stewardship measures implemented to contain AMR must address all the interconnected domains of one health – human, animal and environment • Done by FAO-OIE-WHO-UNEP quadripartite commitment • Since 2010, It’s tripartite....On 17th march 2022, UNEP is added (United Nations Environmental program) as fourth partner • OIE (Office International des Epizooties)...Now this is updated to WOAH (World Organization for Animal Health)
  • 165. ONE HEALTH HIGH LEVEL EXPERT PANEL (OHHLEP) • The advisory panel of OHHLEP whose members represent a broad range of disciplines in science and policy related sectors relevant to one health around the world formulated a new operational definition called as one health approach. • One health is defined as an “Integrated, unifying approach that aims to sustainably balance and optimize the health of people, animals and ecosystems • International One Health Day – November 3rd every year
  • 166. ENVIRONMENTAL STEWARDSHIP SPREAD OF AMR BY EITHER • Gene transfer (i.e. Mutation from pre existing genome) • Horizontal gene transfer (A novel Antimicrobial Resistance Genes (ARGs) from environment)
  • 167. HORIZONTAL GENE TRANSFER • 1st step – Initiated by the ability of donor bacterium to move the ARG within the genome • 2nd step – Relocation of ARG to an element called as conjugative plasmid, so that ARG can move freely between cells • 3rd step – Horizontal transfer of ARG either directly in environment or through several bacterial hosts • 4th step – Physical transfer of bacterium carrying ARG from environment to the human or domestic animal microbiota (Ecological connectivity)
  • 169. VETERINARY STEWARDSHIP • Injudicious use of antimicrobials in animals increasing the antibiotic resistance. • Other than therapeutic use, penicillin, tetracycline, colistin, avoparcin(Glycopeptide), streptogramin, tylosin (Macrolide) were used for growth promotion, egg production, milk production. COLISTIN BANNED IN INDIA AS AN ANIMAL FEED
  • 170. NO ANTIBIOTICS..... FOR VETERINARIES.... • For therapeutic – Vaccination, Immune modulators, Phage therapy • For non-therapeutic (Growth promotors) – Pre and probiotics, Infeed enzymes, Phytochemicals, Clay minerals.....
  • 171. FISHERIES STEWARDSHIP PROGRAMME • Eventhough the use of antimicrobials inn fishereies plays a minor role in antimicrobial resistance, stewardship measures should not be ignored. • Mainly used in ponds and tanks • In ocean (Marine water) calcium and magnesium ions decrease the biological activity of oxytetracycline and fluroquinolones by forming divalent cation complex and it leads to antimicrobial effect loss within a month......
  • 172. MEASURES TAKEN IN AGRICULTURAL STEWARDSHIP • FAO launched InFarm IT platform in 2022. • Each country should upload data in POMS (Plantwise Online management system)
  • 173. HOSPITAL SOURCE CONTROL – UNMET NEED OF AN INTEGRATED ANTIMICROBIAL STEWARDSHIP 1) Timely identification of MDR PEAK ME infections 2) Isolation room for that patients 3) Environmental cleaning after shifting that patient 4) Following correct antimicrobial guidelines 5) Timely de-isolation of the patient 6) Local ground working team to monitor IPC practices
  • 174. MAJOR IPC PRACTICES OF SOURCE CONTROL • Hand hygiene • PPE • Single use of patient dedicated equipment • Following bundle care approach in CAUTI, CLABSI, SSI, VAP and Ryle’s tube • Body care • HCW vaccination
  • 175. ANTIBIOGRAM • Overall profile of antimicrobial susceptibility testing results of a specific microorganism to a battery of antimicrobial agents TYPES: • Routine cumulative antibiograms • Enhanced antibiograms (Location/ICU/Population wise/Age wise) • Subtraction antibiogram (Comparing with last year) • Atleast 30 isolates should be available for each organism to kept ready antibiogram • Should be done annually (Even six months once /more frequently if no. of isolates in each organism is more than 30)
  • 176. MIC CREEP • MIC values are not included in antibiogram • As a result, subtle trends below the resistance threshold are not reflected
  • 177. ANTIFUNGAL STEWARDSHIP • AFS is a component of AMS where antibacterial drugs are replaced by antifungal drugs • AMS team should have mycologist. • AFS program is yet to start in our country • Main efforts are made to shift prophylactic therapy to empirical, empirical to pre- emptive, pre-emptive to targeted therapy
  • 178. ANTIVIRAL STEWARDSHIP • Immunocompromised patients are at increased risk of acquiring a number of opportunistic viral infections-the most common is CMV. (Anti CMV stewardship) • Anti RSV stewardship