its is an introduction to pharmacovigilance, common terms used,who runs the programme in INDIA and how to report an adverse events etc

1. An
Overview
By
Pougang Golmei
M.Pharm (Pharmacology)
RIPANS,Aizawl

2. What is pharmacovigilance?
Who runs the pharmacovigilance?
Why do we need vigilance?
Contents
Pharmacovigilance in India?

3. PHARMACO (GREEK) = medical substance
• Pharmacovigilance (PV) is the science and
activities relating to the detection,
assessment, understanding and
prevention of adverse effects or any other
drug related problem. PV collects, records,
codes ADEs/ADRs analyses and assesses
the reports, promotes the safe use of
drugs, creates appropriate structures and
means of communication needed to
perform its tasks.
VIGILIA (LATIN) = to keep watch

4. AIM & SCOPE
Patient care Patient safety Public health care
Risk-benefits communication Heath training

5. TO IMPROVE PATIENT CARE & SAFETY IN RELATION
TO MEDICINES & ALL MEDICAL & PARAMEDICAL
INTERVENTIONS
To improve public health & safety in relation to the use
of medicines
To contribute to the assessment of benefit, harm,
effectiveness and risk of medicines
To promote understanding, clinical training &
effective communication to health professionals
& the public

6. •Data gathering related to the detection, assessment,
understanding, and prevention of adverse events
•Identifying new information about hazards associated with
medicines, preventing harm to patients
•Post-marketing surveillance (?)
•Medical errors are broader category which includes adverse
reactions but also other factors (diagnostic errors, equipment
failure, nosocomial infections ... )
PHARMACOVIGILANCE

7. Adverse Event (AE) – any untoward medical
occurrence that may present during treatment with a
pharmaceutical product but which does not
necessarily have a casual relationship with this
treatment
Adverse Drug Reaction (ADR) – a response to a drug
which is noxious and unintended, and which occurs at
doses normally used in man.
Serious Adverse Event (SAE) – AE that is either life-
threatening, fatal, cause of prolong hospital
admission, cause persistent disability or concern
misuse or dependence
COMMON TERMS USED IN VIGILANCE

8. Serious Adverse Drug Reaction (SADR) – ADR where SAE
conditions of severity applies
Unexpected Adverse Drug Reaction (UADR) – an adverse
reaction, the nature or severity of which is not consistent
with market authorization, or expected from the
characteristics of the drug.

9. Signal – reported information on a possible relationship
between an adverse event and a drug, unknown or
incompletely documented previously.
Usually more than a single report is required to generate a
signal, depending upon the seriousness of the event and
the quality of the information

10. Expected and Unexpected Events
•Expected are those adverse events that
were observed during clinical trials or
post-approval observations and are
mentioned in Summary of Product
Characteristics (SPC)
•Unexpected are those adverse events
that were not previously observed and are
not documented (in SPC)
•Based on frequency of occurrence there
are following categories of adverse
events:
Category Frequency
Very common
Common
Uncommon
Rare
Very rare < 1/10,000
≥ 1/10
≥1/100 and <1/10
≥ 1/1,000 and <1/100
≥ 1/10,000 and <1/1,000

11. Pharmacovigilance applies to life cycle of a medicine

12. Who runs the vigilance programme?
WHO Programme for International Drug
Monitoring

14. WHO Programme for International Drug Monitoring
National
centre
WHO
Collaborating
centre,
UPPSALA
WHO
Head
quarters

15. What information should be reported?

16. What to report? WHO Recommendation
•Every single problem related to the
use of a drug, because probably
nobody else is collecting such
information
•All suspected adverse reactions
•ADRs associated with radiology
contrast media, vaccines,
diagnostics, drugs used in traditional
medicine, herbal remedies, cosmetics,
medical devices and equipment
•Lack of efficacy and suspected
pharmaceutical defects
•Counterfeit pharmaceuticals
•Development of resistance

17. What to Report (at least)
• Requirements for reporting differ from country to country. However, in
each developed country healthcare professionals are legally obligated to
report adverse reactions (although it is not always clearly stated which)
• It is important to report serious unexpected ADRs – those that are not
described in SPC. Unexpected include also side effects mentioned in SPC
when these occur in higher frequencies then described.
• Most cases of unexpected ADRs are associated with medicines newly
introduced on the market
• It has no sense to report expected adverse
• In clinical praxis it is usually not easy to evaluate causality – report also in
cases you are not sure about causal relationship
• Heathcare professionals may report adverse events also to marketing
authorization holder for a medicine but are not obligated to

18. Who report?
Physicians
Pharmacists
Pharmaceutical companies qualified persons
(Pharmacovigilance/Regulatory manager)
Investigational products (clinical trials)
Post-approval reporting – Individual Case Safety
Report (ICSR), Periodic Safety Update Report
(PSUR)
In many countries patients are encouraged (but not
obligated) to report side effects

19. Who Regulates Drug Safety?
• Slovakia – State Institute for Drug Control, Section of Drug Safety and
Clinical Trials
Czech Republic - State Institute for Drug Control, Pharmacovigilence
department
UK – Medicines and Healthcare Products Regulatory Agency, Vigilence
Risk Management of Medicines
USA – Food and Drug Administration, Center for Drug Evaluation and
Research
India- Central Drugs Standard Control Organization

22. Why do we need pharmacovigilance?
Humanitarian
concern
Promoting
rational use
of medicines
and
adherence
ADR may
cause
sudden
death
Ethics to know
of something
that is harmful
to another
person who
does not know,
and not telling,
is unethical

39. Basic steps in setting up a Pharmacovigilance Centre
Prepare a plan according to the points below for the establishment of the
pharmacovigilance system.
1. Make contacts with the health authorities and with local, regional or national
institutions and groups, working in clinical medicine, pharmacology and toxicology
outlining the importance of the project and its purposes.
2. Design a reporting form and start collecting data by distributing it to hospital
departments, family practitioners, etc.
3. Produce printed material to inform health professionals about definitions, aims and
methods of the pharmacovigilance system.
4. Create the centre: staff, accommodation, phone, word processor, database
management capability, bibliography etc.
5. Take care of the education of pharmacovigilance staff with regard, for example, to:
• data collection and verification
• interpreting and coding of adverse reaction descriptions
• coding of drugs
• case causality assessment
• signal detection
• risk management.

40. 6. Establish a database (administrative system for the storage and retrieval of data
7. Organize meetings in hospitals, academia and professional associations, explaining the
principles and demands of pharmacovigilance and the importance of reporting.
8. Promote the importance of reporting adverse drug reactions through medical journals,
other professional publications, and communications activities.
9. Maintain contacts with international institutions working in pharmacovigilance, e.g. the
WHO Department of Essential Drugs and Medicines Policy (Geneva) and the Uppsala
Monitoring Centre, Sweden