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Tackling AMR at country level
and the role of the Regulator
Telling the South African Story
Dr A T Sigobodhla
VOF meeting: 21st June 2016
What is AMR?
• Antibiotic resistance (AMR) develops when bacteria adapt and grow
in the presence of antibiotics
Spread:
• Resistance to one specific antibiotic agent can lead to resistance to
a whole related class
• Exchange of genetic material between different bacteria
• Circulation in populations of human beings and animals, through
food, water and the environment
• Transmission influenced by trade, travel and both human and animal
migration
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Causes of Antibiotic Resistance
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Animal consumption – an area of focus
Key points
• About 80% of antibiotics used in agriculture
are in feed or water medication.
• The number of effective antimicrobials
available for use is decreasing.
• Upward trend of antimicrobial resistance
patterns: a global concern
• Resistance even exists in the newer groups of
antimicrobials.
For Brazil, Russia, India, China and South Africa, antimicrobial
consumption for animals is expected to grow by 99% by 2030
(13% for humans).
Intensification is a given, but the bad parts that lead to overuse
/need for antibiotics must be unravelled
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Lancet Infect Dis 2016, Apr 12
Background to AMR Strategy in
South Africa
The National AMR strategy and what
has been achieved to date
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Why do we need an AMR strategy
and an implementation plan in RSA?
South Africa’s triple burden of AMR Multidrug resistant organisms
Multidrug
resistant TB (MDR TB)
Drug resistant HIV
DRHIV
The AMR strategy and
implementation plan focuses
on multi drug resistant
organisms
Multi drug resistant
organisms (MDR)
Bacteria and Fungi
How serious is AMR in SA?
SAMJ situational analysis
2011
•The situational analysis
identified multidrug resistant
organisms
• E. Coli, S. aureus and K.
pneumoniae
•Prevalence of about 25% in a
sample of human hospitals
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South Africa’s AM use data – 3 sources
Human
Animal
Human
Source: SARS import data –
2010-2015
Other
Pen/strep
antibiotics
1 046 tons pa 4 154 tons pa
Increase: 141% incr penicillin
11% incr for others
Limitations: Excl local
manufactured data, imported
unregistered Abs
Source: IMS data - Period 2000 – 2010
Standard units/ 1000 population
By antibiotic class
Public private usage can be
compared
Increase: 175% over 10 years (Pub
360%, priv 21%)
(58% excl trimethoprim)
Limitations: excl imported
unregistered Abs
no split between hosp/community
Source: Source: CHAI – supplier
order fulfilment data, Standard
units and DDD’s
By antibiotic class
Split by province but not by
facility type
Direct delivery hospitals
data available
No community data split
Limitations: excl
unregistered imported Abs
Excl out of contract
purchases
Penicillins
Percentages of volume (kg) for sales of
antimicrobials for veterinary use for the
period 2002 – 2004.
Cephalosporins
Tetracyclines
0.30%
4.50%
10.70%
0.80%
6.20%
12.40%
16.70%
Aminoglycosides
Macrolides,
lincosamides and
pleuromutilins
Quinolones
5.50%
0.07%
0.20%
Quinoxalines
42.40%
Sulphonamides
Polipeptides
Ionophores
Percentage of dosage
forms/administration route of
antimicrobials sold in South Africa
1.50%
In feed antimicrobials
0.04%
Parenteral antimicrobials
12.00%
17.50%
Water soluble
antimicrobials
69.00%
Intramammary
antimicrobials
Other antimicrobial
dosage forms
Diagram based on Linton (1977), as adapted by Rebecca Irwin, Health Canada (Prescott 2000) and IFT
The South African AMR initiative started at
the summit in October 2014.
Brought together key stakeholders from government, laboratory
services, clinician societies, civil societies and regulatory bodies
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The summit culminated in all stakeholders signing a
commitment
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Pillars of the South African AMR
Strategy Framework
Impact: Rational Antimicrobial
use and improved patient outcomes
Enablers
Strategic objective
Antimicrobial resistance Governance
Diagnostic
stewardship
Enhance
Surveillance
Prevention
Antimicrobial including IPC
Stewardship
and
vaccination
Health systems strengthening, research, education and
communication
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Activities have been aligned to each of
the AMR strategy pillars
Ministerial Advisory Committee (MAC) on
AMR now appointed
Veterinarians
Laboratories –
NHLS/NICD,
SASCM and
private
Clinicians, family
Dr’s, pharmacists,
microbiologists and
nurses
Regulators and
policy makers
DTI ,DBE, DAFF
Military, DCS
MAC on
AMR
NHC has approved the MAC and the call for
nominations is currently underway
HIV, TB
representatives
Implementation Plan for AMR
• Implementation plan
has been approved
• Published online in
February 2016
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Colistin example as a burning
issue now in South Africa
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Colistin
• Introduced for human use in 1959, and withdrawn again in
1970s over fear of nephrotoxicity
• Re-introduced as salvage therapy in extensive drug resistant
Gram-negative infections (Pseudomonas aeuruginosa,
Acinetobacter baumanii, Enterobacteraceae)
• Current indications for use:
• P. aeruginosa in cystic fibrosis
• Pneumonia due to extensively resistant Gram-negative
microorganisms
• Septicaemia and pneumonia caused by carbapenemase-producing
Enterobacteraceae
• Old school of thought: resistance to colistin
through mutation or adaptation mechanisms.
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•It was found in E. coli in 20.9% of pigs surveyed at slaughter, 22.3% of raw
pork products, 28% of chicken products and in 13/902 (1.4%) of patients
being treated for E. coli infections and 3/420 (0.7%) with Klebsiella
pneumoniae infections
•The emergence of MCR-1 heralds the breach of the last group of antibiotics,
polymyxins, by plasmid-mediated resistance.
•Urgently requires the re-evaluation of the use of polymyxins in animals.
Current situation in the world
China:
• Major increase in colistin resistance recently
documented
• Due to a highly mobile transferable plasmidmediated colistin resistance: MRC-1
Raw Retail Meat (Chicken & Pork)
2011 - 2014
Pigs (2011 - 2014)
21%
15%
E. coli MRC-1 Negative
E. coli MRC-1 Negative
E. coli MRC-1 Positive
E. coli MRC-1 Positive
85%
79%
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Current situation in South Africa
Poultry in South Africa:
• Second half of 2015: substantial
increase in E. coli strains resistant
to colistin in
poultry operations.
• Possibly due to spread of MRC-1
gene in operations where colistin is
used.
Humans:
• MRC-1 gene detected in 3
hospitalised and 4 nonhospitalised patients
Colistin Resistance in
Poultry 2015
MRC-1 Positive
21%
MRC-1 Negative
79%
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Increasing colistin resistance in pathogenic E. coli in
South African Poultry operations
V-Tech, 11th Jan 2016
Antibiotic Use Awareness
• 1. Following the introduction of the European Antibiotic
Awareness Day, South Africa also participated, by
declaring 17 – 22 November as Antibiotic Awareness
Week
• 2. Antimicrobial Resistance Action Plan: Department of
Agriculture Forestry and Fisheries Public Hearings were
held from January to March 2016
• Both were done to promote one of the key enablers of
the AMR Strategic Framework: increase community
awareness on the risks of inappropriate antibiotic
use.
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Recommendations
• Antibiotic use with veterinarian oversight
• Prescription based on laboratory sensitivity testing
• Treatment or metaphylaxis of clinically affected animals: no
prophylaxis?
• Compounding of antibiotics be prohibited until local
resistance data and current data on quantities of drugs used
becomes available to allow a review (risk assessment) of the
risk that antibiotic use poses for use in human therapy?
• Recommend how the profession, the farmer and the public
can assist to combat the fact that very large volumes of
antibiotics are entering the country and are used in feed and
water for prophylaxis and possibly entering the food chain?
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Monitoring & Evaluation
Indicators we will be monitoring to determine impact of any
changes in AMR:
• Reduction in key resistant organisms
• Reduction in national consumption of antibiotics linked to key
resistant organisms
• Reduction in mortality from infectious diseases
• Reduction in neonatal mortality from infectious diseases
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AMR strategic objectives of relevance to
the Regulators
• Optimise registering of animal and human
antimicrobials
• Specific role in:
– Controlling the registration and the quality of medicines in
the country
– Facilitating the registration and supporting the availability
of animal medicines and vaccines
– Improving the fast track registration process for key
Antimicrobials
– Improve the procedure for importation and use of
unregistered Antimicrobials access including the improved
control thereof within the country
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National Surveillance Collaborations have
started
Resistance percentage
60%
50%
40%
30%
20%
10%
0%
2012
2013
2014
Year
Public Labs
SA dataset
Private labs
Map and
trends
World
comparison
Next steps
• Provision of line item data from all labs and practitioners
• Lab based reporting
Thank you
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