CONTENTS

INTRODUCTION
AIM AND OBJECTIVES
GOALS OF PHARMACOVIGILANCE
FUNCTIONS OF PHARMACOVIGILANCE AT VARIOUS LEVELS
ADVERSE DRUG REACTIONS
PHARMACOVIGILANCE IN DRUG REGULATION
PHARMACOVIGILANCE METHODS IN ADR DETECTION
ROLES OF HEALTH PROFESSIONALS
PARTNERS OF PHARMACOVIGILANCE
PREVENTING OF ADRs
MONITORING OF ADRs
CONCLUSION
REFERENCES






WHAT IS PHARMACOVIGILANCE?
Pharmakon (Greek) : Medicinal substances
Vigilia (Latin) : To keep watch

DEFINITION :
The science and activities relating to the detection,
assessment, understanding and prevention of adverse
effects or any drug related problems
All the medicines with the ability to produce the
desired therapeutic effect also have the potential
cause the unwanted adverse effects. The important to
monitor both known and unknown side effects of
medicines in order to determine any new information
related to their safety profile.


AIM :
To identify new information about hazards as associated
with medicines.

OBJECTIVES :
Improve patient care and safety.
Improve public health and safety.
Encourage safe, rational and appropriate use of drugs.
Promote advertising, education and clinical training in
pharmacovigilance.

GOALS OF PHARMACOVIGILANCE
Monitors the quality of drugs.
Identify the health risks involved in
administration of certain drugs.
Prevent harm to patients.
Research and efficacy of the drugs.

NATIONAL PHARMACOVIGILANCE CENTRE

NATIONAL PHARMACOVIGILANCE PROGRAMME

PERIPHERAL PHARMACOVIGILANCE CENTRES

REGIONAL PHARMACOVIGILANCE CENTRE

ZONAL PHARMACOVIGILANCE CENTRE


HOW PHARMACOVIGILANCE WORK?

ADR SUSPICION ADR REPORTING



SHARING OF ADR ANALYSIS
FINDINGS
ANALYSIS
RESPONSE
DATA
ADVERSE DRUG REACTIONS
TYPES OF ADRs
Type A effects(augmented) : common ,dose dependent and
predictable
Type B effects (bizzare) : rare, dose independent and
unpredictable
Type C effects (chronic) : after long term therapy no time
relationship
Type D effects (delayed) :may be prevented years after
Type E effects : absence of drug after withdrawn
(end of treatment)
FACTORS AFFECTING SUSCEPTABILITY TO ADRs
1.Age 4.Ethnicity
2.Gender 5.pharmacogenetics
3.co-mobidities & concomitant 6.porphyrias
medicines used
Drug combinations Irrationality
1.Gramnegativeantibacterials+anti
staphylococcal antibiotics
E.g: ampicillin+ cloxacillin
2.Antibacterials+antiamoebi c agents
E.g:ciprofloxacin+metronidazole/ofloxacin+
ornidazole
3.NSAIDS combinations
E.g:nimeslide+diclofenac
4.Antiemetics + Antacids
E.g:dompertidon+ranitidine
5.Antacids+antianxiety drugs
E.g:diazepam+antacids
Results increase resistanse of bacteria,
greater side effects, increase duration of
therapy & cost of treatment.
Ameobiasis and bacterial diarrhoea are
usually foond together in patient.one of
the drugs is wasted.

Risk of nephrotoxicity I increased
Peptic ulcer is not always associated
with emesis. increase cost of treatment.
Antacids reduce the absorption of anti-
anxiety drugs.
DRUGS BANNED IN INDIA
Amidopyrine
Fixed dose combinations of atropine in analgesics and
antipyrine
Fixed dose combinations of strychnine and caffeine in
tonics
Tetracycline liquid oral preparations
Fived dose combinations of penicillins with
sulphonamides
Fixed dose combinations of vitamins with analgesics.
Penicillins skin/eye ointment.
DRUGS PROHIBITED FOR IMPORT
Drugs formulation
Effective data Notification
1.cosmetics licensed as
toothpaste/tooth powder
containing tobacco
2.Parenteral preparations fixed
dose combinations of
streptomycin with penicillin
3.Fixed dose combination of
phenobarbitone with anti-
asthmatic drugs
4.Fenformin
5.Rofecoxib


With immediate
effect

Jan. 1, 1998


Jan. 1, 2002

Oct. 1 , 2003

Dec. 13, 2004

GSR 444(E)


GSR 93(E)

GSR 170(E)

GSR 780(E)
GSR 810(E)
PHARMACOVIGILENCE IN DRUG
REGULATION
CLINICAL TRIAL REGULATION
1.collection of ADR
2.monitoring clinical data
3.reporting of clinical data
POST MARKETING SAFETY MONITORING
PHARMACOVIGILANCE METHODS IN
ADR DETECTION
SPONTANEOUS REPORTING
It is the core data generating system, relying on health
care professionals to identify and report any adverse
events to their NPC, health authority or drug manufacturer
1.Signal detection 2.causality assessment
YELLOW CARD SCHEME
This scheme is operated MHRA ,they submit report on
ADRs using yellow card or on-line form
PUBLISHED CASE REPORTS
The first suspicions of unpredictable reactions may often
be seen in a case report from a practioner e.g: cases of
thalidomide and practolol
COHORT STUDIES
1. These studies monitor large group of patients taking a
particular drug over a period of time
2. These studies can indicate the relative risks associated with
the adverse event in people exposed to drug being studied
CASE-CONTROL STUDIES
1. These studies are an effective method of confirming
whether are not a drug causes given reaction once a
suspicions has been raised.
2.By comparing the prevalence of drug taking between the
groups, it may be possible to identify whether significantly
more people who experienced the event also took a
particular drug.

WHO SHOULD REPORT SAFETY DATA
Physicians
Pharmacists
Pharmaceuticals companies qualified persons-
(pharmacovigilance/regulatory managers).
Investigational products (clinical trails).
Post-approval reporting individual case safety
report(ICSR), periodic safety update reports(PSUR).
In many countries patients are encouraged to report
side effects.


WHAT TO REPORT?
It is important to report serious unexpected ADRs.
Most cases of unexpected ADRs are associated with
medicines newly introduced in the market.
Al suspected adverse reactions.
Every single problem related to the use of a drug.
ADRs associated with the radiology contrast media,
vaccines, diagnostics, drugs in traditionalmedicines,
herbal remedies, cosmetics, medical devices and
equipment.

SYSTEM OF SAFETY DATABASES


Health
professional
Patients
Pharmaceutical
companies
National
Regulatory
Authority
Clinical
Trails
International
Safety databases

Pre-approval
Post-approval
ROLES OF HEALTH PROFESSIONALS
Ensuring medicines are used safely is fundamental to the
role of all health professionals who prescribe, supply,
administer, monitor or advise on their use.
They should take of all relevant patent factors, which may
predispose to an ADR as co-morbidities, concomitant drugs,
renal &liver function and genetic predisposition.
An important role all health professionals is the
documentation identified ADRs.
Identifying and assessing ADRs in clinical practice.
Pharmacists in particular , because of their role in
dispensing prescriptions, may also be involved in educating
and supportying others in preventing ADRs.
PATNERS IN PHARMACOVIGILANCE
The WHO quality assurance and safety: medicines
team
The uppsala monitoring centre (UMC)
Hospitals and academia
Health professionals
Patients
Other partners
PREVENTING OF ADRs
ADRs can be prevented by checking previous ADR history.
Minimizing the use of drugs known to carry high risk of
ADRs.
Tailoring drug selection to individuals based on the factors
which predispose them to ADRs.
Increasing regular review of medicines.
Improved sharing of information about patients between
health care providers.
Increasing availability of guidance on drug selection.
Increase rational prescribing, which may have an effect on
incidence on ADRs.
MONITORING THERAPY
Monitoring the effects of drugs either by direct
measurement of concentration or by measurement of
physiological markers is another potential mechanism to
reduce risk o ADRs.
Advice on monitoring should be clear, provide an evidence-
based frequency of monitoring and acceptable values.
An examination of adequacy of manufacturers advice on
monitoring for haematological ADRs found useful to
prescribers.


CONCLUSION
Pharmacovigilance is used for preventing patients from
being effected unnecessarily.
Work of WHO is the area of safety monitoring of medicines
is necessary if we are to achieve the mission of EDM.
Medicines should be available, affordable safe and properly
used.
Think less about drug safety and more about patient safety.
Think more about impact and consequences of decisions
and non-decisions.
REFERENCES
Clinical pharmacy and therapeutics, Roger walker
and cate whittlesea ; fifth edition.
The importance of WHO 2002.
Who technical report no:498(1972).
Pharmacovigilance pragmatic appraoches, 2001,
Geneva.
Administratio regulatory.
WHO global ICSR database system: basic facts.
Drug information journal 2008.
ICH E2B standard E2B


Data elements for transition of individual case safety reports
ICH E2B standard.
Pharmacovigilance mann RD, Andrews EB, eds.john wiey
& sons ltd, chichester,2002.
Organization ICH.
Organization of Steering committee.
History of involvement in drug safety monitoring by WHO
Sara gambrill,2011 ,chnas pharmacovigilance system: the
hunger for safety insights, clinical leader ,Dec 7,2011
accessed march 28 2014.