Pharmacovigilance is the science of monitoring the safety of medicines. It aims to detect adverse effects from drugs, understand their causes, and prevent patient harm. Pharmacovigilance programs collect reports of adverse drug reactions and analyze the data to identify safety issues, quantify risks, and communicate safety information to patients and healthcare professionals. The ultimate goals are to protect patients and promote the safe use of medicines.

1. BISHNU PRASAD KOIRALA
M.PHARMA(PHARMACEUTICS)
SHREE DEVI COLLEGE OF PHARMACY,
MANGLORE

2.  WHO’s definition: The science and activities relating to the
detection,
assessment, understanding and prevention of adverse effects or any
other drug-related problem.
OR
 Pharmacovigilance (PV), also known as drug safety, is the
Pharmacological Science relating to the collection, detection,
assessment, monitoring, and prevention of Adverse effects with
pharmaceutical products.
 The word Pharmacovigilance arises from the Greek word
”pharmakon” – pharmaceutical and Latin word
“vigilare” – vigilant

3.  Insufficient evidence of safety from clinical trials
 Medicines are supposed to save lives
 To KEEP products on the market
 To protect patients from unnecessary harm
 To reduce healthcare expenses
 Because any medicine can be implicated
 Promoting rational use of medicines and adherence
 Ensuring public confidence
 Ethical thing to do
 It can unveil lapses in BEST PRACTICES

4.  To protect the patients
 To comply with the legislation
 The information collected during the pre-marketing phase of a medical
drug is inevitably incomplete with consider to possible adverse reactions:
• information about rare but serious adverse reactions, chronic toxicity, use
in special groups (such as children, the elderly or pregnant women) or drug
interactions is often incomplete or not available. Pharmacovigilance is
needed in every country, because there are differences between countries
(and even regions within countries) in the occurrence of adverse drug
reactions and other drug-related problems. This may be because of
differences in:

5. • Drug Production
• Distribution and use (e.g. indications, dose, availability)
• Genetics, diet, traditions of the people
• Pharmaceutical quality and composition (excipient) of locally produced
pharmaceutical products
• The use of non-orthodox drugs (e.g. herbal remedies) which may pose
special toxicological problems, when used alone or in combination with
other drugs.

6.  Adverse reaction: Also called an adverse drug event (ADE), adverse drug
reaction (ADR), adverse effect or adverse event.
 In pharmacology, any unexpected or dangerous reaction to a drug. An
unwanted effect caused by the administration of a drug. The onset of the
adverse reaction may be sudden or develop over time.
OR
 In medicine, an adverse effect is an undesired harmful effect resulting from
a medication.

7. OR
 Acc. To WHO: ‘A response to a drug which is noxious and
unintended, and which occurs at doses normally used in man
for the prophylaxis, diagnosis, or therapy of disease, or for
the modifications of physiological function'.

8.  An adverse reaction which results in death, is life-threatening, requires in-
patient hospitalisation or prolongation of existing hospitalisation, results in
persistent or significant disability or incapacity, or is a congenital
anomaly/birth defect.

9.  An ADR is a harmful response in the patient caused by the drug itself given
in the recommended manner (dose, frequency, route, administration
technique). Examples include allergic reactions, effects from withdrawal,
or reactions caused by interactions with other medications.

10.  The drug regulatory planning provide the underpinning for
a national ethos of drug safety, and for public self-assurance
in medicines. The issues with which drug regulatory
authorities have to contend besides the approval of new
medicines, include:
• clinical trials
• safety of complementary and traditional medicines,
vaccines and biological medicines
• developing lines of communication between all parties
with an interest in drug safety and ensuring that they are
open and able to function efficiently, particularly at times of
crisis.

11.  Pharmacovigilance programmes need strong links with regulators to
ensure that authorities are well briefed on safety issues in everyday
practice that may be relevant to future regulatory action. Regulators
understand that Pharmacovigilance plays a specialized and essential
role in ensuring ongoing safety of medicinal products.
 REGULATORY AGENCIES OF DIFFERENT COUNTRIES

12.  Outlining Pharmacovigilance process in nine simple steps as below.
Step 1: Support use of accredited Institutional Review Boards (IRBs).
Step 2: Timely register of human clinical trials in the federal Data
Bank.
Step 3: Attend to Phase IV study commitments.
Step 4: Establish and implement company policy regarding the
disclosure of clinical trial results.
Step 5: Recognize that there is a growing focus on post-approval
review, and a changing role for both private and public payers like the
Centers for Medicare & Medicaid Services (CMS).
Step 6: Anticipate the impact of negative trial results on indications,
labeling and approval status.
Step 7: Prepare Direct-To-Consumer (DTC) advertising programs to
withstand further heightened scrutiny.

13. Step 8: Stay current on evolving preemption law and policy.
Step 9: Continually update employees on changing standards, and the
implications for your business.

15. Summary of product characteristics (SPC)
-basis of information for healthcare professionals on how to use the
medicinal product safely and effectively
Patient information leaflets (PIL)
Accordance with the SPC
Change In Classification
-From Over The Counter To Prescription Only Medicine
- From renewal prescription to non-renewable
- special medical prescription
- restricted prescription

16. Marketing Authorization Withdrawal
Batch recall based on clustering of ADRs

17. - IN UK
 Yellow Card Scheme
 Adverse Drug Reactions Online Information Tracking System.
 Eudra Vigilance:
EudraVigilance is the system for managing and analysing information on
suspected adverse reactions to medicines which have been authorised or
being studied in clinical trials in the European Economic Area (EEA).
- IN USA
 MEDWATCH:
MedWatch is the Food and Drug Administration’s Safety Information and
Adverse Event Reporting Program. It is used for reporting an Adverse
event or sentinel event.

18. - IN AUSTRALIA
 TGA
 ARCS

19.  Early detection of unknown safety problems
 Detection of increases in frequency
 Identification of risk factors
 Quantifying risks
 Communicating information
 Preventing patients from being affected unnecessarily