PHARMACOVIGILANCE

Its role in AMR control

Jarir At Thobari

Yogyakarta, 16 August 2018

 Thalidomide (1961-1962)

Some remedies are worse than the disease”

Publilius Syrus, Roman writer, 1st century BC.

Yogyakarta, 16 August 2018

 No Therapy that is effective is
free of adverse drug effects
All active pharmaceuticals have potential to cause harm

Yogyakarta, 16 August 2018

Not all the drugs are effective

Yogyakarta, 16 August 2018

 AMR cause ineffective treatment

• Hundreds of thousands of deaths each year

due to antibiotic resistance

38,000

58,000

23,000

25,000

Yogyakarta, 16 August 2018

 Risk
• No medicinal product is entirely or absolutely safe and
effective for all people, in all places, at all times. We must
always live with some measure of uncertainty.

PV can characterise
that risk

Yogyakarta, 16 August 2018

 Pharmacovigilance
• WHO defined as
– 'the pharmacological science and activities relating to the
detection, assessment, understanding and prevention of
adverse effects or any other drug-related problem‘
• An umbrella term used to describe the
processes for monitoring and evaluating
safety and effectiveness of medicine
– is a key component of effective drug regulation systems,
clinical practice and public health programs.

Yogyakarta, 16 August 2018

 Scope of Pharmacovigilance
Unexpected lack of Medication
Adverse Reactions effect errors

● Properties of Inadequate quality Inadequate use

drug and patient • GMP Human factors
● Pharmacologic • Distribution Failing health
● Hypersensitivity • Storage etc. systems
● Other
Antimicrobial
resistance

Inadequate use

Yogyakarta, 16 August 2018

 Aims of Pharmacovigilance

• early detection
• detection of increases in frequency
• identification of risk factors
• quantifying risks
• communicating information
• preventing patients from being affected
unnecessarily

Yogyakarta, 16 August 2018

Monitoring Antimicrobial Sensitivity Patterns
(Surveillance)

▪ Surveillance is an essential component

▪ Use the data
▪ For individual patient safety report (ICSR) for
ineffective antibiotic treatment
▪ Data collection methods
▪ Analyse isolates from community-acquired
infection separately from isolates from
nosocomial infection
▪ Laboratory quality assurance
▪ Internal and external quality assurance are
needed for laboratory

Yogyakarta, 16 August 2018

 JCI &
SNARS

Measurable Elements of MMU.7

1. Medication effects on patients are monitor, including adverse effect
2. The monitoring process is collaborative
3. The organization has a policy that identifies those adverse effects that are to be
recorded in the patient’s record and those that must be reported to the organization
4. Adverse effects are documented in the patient’s record as required by policy
5. Adverse effects are reported in the time frame required by policy

Yogyakarta, 16 August 2018

 Drug Therapeutic Committee (DTC)

With Infection Control With microbiology department

Committee to reduce spread for collection and management
of resistant pathogens of information on pathogens and
resistance patterns

With pharmacy to
improve
antimicrobial
procurement DTC With hospital
management
and quality
to develop
and implement
With different departments for policies on
education of students, physicians, antibiotic use
pharmacists, nurses, and patients

Yogyakarta, 16 August 2018

Challenge of PV: The use of Antibiotic
• Antibiotic consumption pattern
– Irrational drug use
– overuse, underuse
– increasing self-medication practice
– lack of control mechanism over drug sale

Pharmacovigilance programs should include public awareness

and education of patients in rational use of antibiotic to ensure
better health care

Yogyakarta, 16 August 2018

 Role of PV
• Reporting on antimicrobial treatment
failure can be an indication of two
major public health issues:
– Presence of antimicrobial resistance
and/or
– Medicines of poor quality.
• Detection of clusters of adverse events
can be an enabling factor in
identification of resistance spread
patterns in the respective area

Yogyakarta, 16 August 2018

 Role of PV in AMR control
● To improve patient care & safety in relation
Patient Care to medicines & all medical & para-medical
interventions

● To improve public health & safety in

Public Health relation to the use of antibiotic

Risk Benefit ● To contribute to the assessment of

Assessment effectiveness and risk of use antibiotics

● To promote understanding, clinical

Communication training & effective communication to
health professionals & the public

Yogyakarta, 16 August 2018

Yogyakarta, 16 August 2018
Yogyakarta, 16 August 2018
Yogyakarta, 16 August 2018