PRESENTATION ON

PHARMACOVIGILANCE
PHARMACOVIGILANCE

The etymological roots for the word

"pharmacovigilance" are: pharmakon (Greek for
drug) and vigilare (Latin for to keep watch).
PHARMACOVIGILANCE – BEFORE
AUTHORIZATION
Before a medicine is authorized for use, evidence of its
safety and efficacy is limited to the results from clinical
trials, where patients are selected carefully and followed
up very closely under controlled conditions.
This means that at the time of a medicine's authorisation,
it has been tested in a relatively small number of selected
patients for a limited length of time.
PHARMACOVIGILANCE – AFTER
AUTHORIZATION
After authorization the medicine may be used in a large
number of patients, for a long period of time and with other
medicines. Certain side effects may emerge in such
circumstances.
It is therefore essential that the safety of all medicines is
monitored throughout their use in healthcare practice.
CLINICAL TRIALS
CLINICAL TRIALS is a research method that studies the
effect of drugs or treatment on human beings .
There are four different phases of clinical trials in
pharmacology
Phase 1 Clinical Trials:

. - Role: In Phase 1 trials, the focus is on assessing the safety,

tolerability, and pharmacokinetics of a new drug in a small number
of healthy volunteers.
- Pharmacovigilance Involvement: During this phase,
pharmacovigilance is primarily concerned with closely monitoring
participants for any adverse events or safety concerns. The focus is
on identifying any unexpected side effects and assessing the drug's
overall safety profile.
Phase 2 Clinical Trials:

- Role: Phase 2 trials involve a larger group of participants to

further evaluate safety and begin to assess the drug's efficacy.
- Pharmacovigilance Involvement: In this phase,
pharmacovigilance continues to monitor participants for adverse
events and ensures that any emerging safety concerns are
captured. Additionally, pharmacovigilance may contribute to the
analysis of safety data to support dose selection and patient
population considerations for Phase 3 trials.
Phase 3 Clinical Trials:

. - Role: Phase 3 trials are pivotal for demonstrating the

efficacy and safety of the drug in a larger patient population.
- Pharmacovigilance Involvement: Pharmacovigilance plays a
significant role in Phase 3 trials by closely monitoring
participants for adverse events, including serious adverse
events. Adverse events are recorded, analyzed, and reported
to regulatory authorities as part of safety reporting
requirements. This phase provides crucial safety data for
regulatory approval
Phase 4 Clinical Trials (Post-Marketing Phase):

- Role: Phase 4 trials occur after regulatory approval and involve

monitoring the drug's safety in real-world use.
- Pharmacovigilance Involvement: Post-marketing
pharmacovigilance is a core focus of Phase 4 trials.
Pharmacovigilance activities include ongoing monitoring of adverse
events, signal detection to identify potential safety concerns, and
periodic safety reporting to regulatory authorities. The goal is to
ensure that any emerging safety issues are promptly identified and
managed.
Pharmacovigilance
"Pharmacovigilance is the science and activities
relating to the detection, assessment, understanding
and prevention of adverse effects or any other
medicine-related problem" - As defined by WHO
PURPOSE OF PHARMACOVIGILANCE

1. The main purpose of pharmacovigilance is to improve the

patient's safety and enhance his care in terms of the use
of medicines, including paramedical interventions.
2. Pharmacovigilance also supports public health programs
by providing reliable information for the efficient
assessment of the risk-benefit profile of medicines.
PURPOSE OF
PHARMACOVIGILANCE
3. Contribute to the assessment of benefits, uses, side
effects, harm, effectiveness and risk of medicines.
4. Encouraging the safe, rational and more effective
(including cost-effective) use of various medicines.
5.Promote education, understanding and clinical
training in pharmacovigilance and its effective
availability to the public.
Pharmacovigilance involves 2 key steps:

1. Detection: This step involves detecting any potential

adverse drug reactions. This is done by monitoring clinical
trials, post-market surveillance, and other data sources.
2. Evaluation: This step involves assessing the potential risks
and benefits of the drug. This includes examining the data
from the detection step as well as consulting
 IMPORTANT OF PHARMACOVIGILANCE

A better understanding of the drug’s safety profile

Pharmacovigilance can help better understand a particular
medication’s safety profile. We can use this information to make
safer decisions when prescribing that medication in advance.
Reduced risk of drug abuse and diversion
Pharmacovigilance can help to identify any potential issues with
a medication that could lead to its abuse or diversion.
IMPORTANT OF
PHARMACOVIGILANCE
1.Reduced risk of product liability lawsuits
Pharmacovigilance can help detect potential medication
problems before they cause severe injury or death. This
information can help to prevent future product liability
lawsuits
ROLE OF PHARMAVIGILANCE IN PUBLIC HEALTH

Shielding Patients from Adverse Drug Reactions

Adverse drug reactions, unintended and harmful effects of
medications, can range from mild discomfort to life-threatening
complications. Pharmacovigilance acts as a vigilant guardian,
constantly monitoring for adverse events and providing early
warning signals. This proactive approach allows for timely
interventions, such as modifying drug dosages, issuing safety
warnings, or even withdrawing medications from the market,
preventing further patient harm.
ROLE OF PHARMAVIGILANCE IN
PUBLIC HEALTH
2.Advancing Drug Safety through Continuous Surveillance
Pharmacovigilance doesn't end with a drug's approval; it's an
ongoing process that spans the entire lifecycle of a
medication. Continuous surveillance ensures that any
emerging safety concerns are promptly identified and
addressed, even years after a drug's introduction. This
vigilance is particularly crucial for new drugs, as their safety
profiles may not be fully understood until they are used by a
larger population.
ROLE OF PHARMAVIGILANCE IN
PUBLIC HEALTH
3.Empowering Informed Decisions with Reliable Data
The insights gleaned from pharmacovigilance activities
provide healthcare professionals and regulatory bodies with
a wealth of information to make informed decisions about
drug safety. By analyzing patterns of ADRs, identifying risk
factors, and assessing the overall benefit-risk balance of
medications, pharmacovigilance guides the safe and
effective use of pharmaceuticals.
ROLE OF PHARMAVIGILANCE IN
PUBLIC HEALTH
4. Fostering Public Trust in Medications
Public trust in medications is essential for maintaining a
healthy society. Pharmacovigilance, by ensuring the safety
of drugs and promptly addressing any emerging concerns,
plays a vital role in upholding this trust. When patients are
confident that the medications they are prescribed are safe
and effective, they are more likely to adhere to treatment
regimens, leading to better health outcomes.
KEY TERMS IN PHARMAVIGILANCE

Vaccine vigilance is the part of pharmacovigilance that

deals with the safety of vaccine administration.
An adverse drug reaction (ADR) is an unwanted or
harmful reaction experienced following the administration
of a drug or combination of drugs under normal conditions
of use and is suspected to be related to the drug. An ADR
will usually require the drug to be discontinued or the dose
reduced.
KEY TERMS IN
PHARMAVIGILANCE
Adverse Event (AE) : An adverse event refers to any
untoward medical occurrence in a patient or clinical trial
subject who has been administered a medicinal product. It
is important to note that an adverse event does not
necessarily have a causal relationship with the treatment
received. Adverse events can occur during the use of a
medicinal product within or outside the terms of the
marketing authorization. They can also arise from
occupational exposure.
KEY TERMS IN
PHARMAVIGILANCE
“Serious Adverse Drug Reaction or Adverse Event”
is any untoward medical occurrence that at any dose:
results in death, is life threatening requires in patient
hospitalization or results in prolongation of existing
hospitalization , results in persistent or significant
disability/incapacity , is a congenital anomaly/birth
defect and is a medically important event or reaction
KEY TERMS IN
PHARMAVIGILANCE
“Adverse Events Following Immunization (AEFI)”
An Adverse Event Following Immunization is any
untoward medical occurrence which follows
immunization and which does not necessarily have a
causal relationship with the usage of the vaccine. The
adverse event may be any unfavorable or unintended
sign, abnormal laboratory finding, symptom or
disease.
KEY TERMS IN
PHARMAVIGILANCE
 “Adverse Drug Reaction Report” An
adverse drug reaction report is a detailed
record of all relevant data associated with the
use of a medicine in a subject or patient.
DIAGNOSING ADVERSE DRUG REACTIONS

Following step-wise process can be helpful in assessing possible drug-

related adverse reactions:
Step 1 – Identify the drug(s) taken by the patient.
Step 2 – Verify that the onset of signs and symptoms was after the
initiation of pharmacological intervention.
Step 3 – Determine the time-interval between the initiation of drug
therapy and the onset of signs and symptoms.
DIAGNOSING ADVERSE DRUG
REACTIONS
Step 4 – Stop drug therapy and monitor signs and
symptoms.
Step 5 – In rare instances it may be appropriate to
restart drug therapy and monitor for recurrence of
signs and symptoms
PREVENTION OF ADVERSE DRUG REACTIONS

Avoid incorrect use of drugs in the circumstance of clinical

condition.
Use the drug at the right dose, by the correct route, and at
the correct frequency.
The particular attention is essential regarding drug dose
and response in neonates and geriatric patients and also
about renal, hepatic, and cardiac disease patients.
PREVENTION OF ADVERSE DRUG
REACTIONS
The drugs should be used only when there is a need and
clear indication for use and there is no other alternative to
use.
The need for continuing treatment should be regularly
reviewed and stop the drug which is not necessary.
Before the use of any drug first collect the previous
medication history, especially considering the untoward
incidents with the use of a particular drug.
PREVENTION OF ADVERSE DRUG
REACTIONS
Collect the information of allergic history.
Drug alert carts are used for those drugs which
have an incidence of adverse reactions thus such
carts can reduce the number of ADRs.
Rule out drug interactions.
PREVENTION OF ADVERSE DRUG
REACTIONS
Be aware of interactions with certain foods, alcohol, and even
household chemicals.
The role of the pharmacist is to prevent ADRs by daily visits to the
nursing units to discuss possible and reported ADR also by patient
interviews and study all medications prescribed to treat adverse drug
reactions.
Adopt the right technique e.g. slow I.V. injection of aminophylline.
Appropriate monitoring is required. For example: Prothrombin
Time (PT) with warfarin
MANAGEMENT OF ADVERSE DRUG
REACTIONS

Start with low doses and frequencies and slowly titrate as

tolerated.
Initiate less-potent agents, agents with direct mechanisms
of action, or alternatives with lower adverse event
incidence.
Avoid or reduce the use of interacting medications
MANAGEMENT OF ADVERSE DRUG
REACTIONS
Prescribe dosage forms with minimal systemic
exposure (eg creams, patches).
Reduce dosing or discontinue the offending
medication.
Switch to another agent or dosage form less likely
to cause ADRs
MANAGEMENT OF ADVERSE DRUG
REACTIONS
Treat side effects when necessary (beware of
prescribing cascades).
Express empathy and maintain a trusting
relationship with the patient.
Document the ADR in the patient’s medical
record.
REPORTING “ADVERSE EVENT OR ADVERSE
DRUG REACTION

What to Report

For all products the following should be reported:

Adverse drug reactions (ADR) resulting from non-prescription and
prescription drugs (including biological products and
radiopharmaceutical products).
Adverse reactions resulting from herbal medicinal products and food
supplements medical devices, cosmetics and household chemical
substances.
REPORTING “ADVERSE EVENT
OR ADVERSE DRUG REACTION
What to Report

Drug abuse, drug overdose, drug interactions, quality defects,

poor packaging, questionable stability, suspected contamination,
suspected counterfeit and lack of therapeutic efficacy.
Adverse events resulting from products used during phase IV
clinical studies.
 REPORTING “ADVERSE EVENT
OR ADVERSE DRUG REACTION
Information to be provided on the Reporting Form
Patient Details
1. Age/Date of Birth,
2. Sex,
3. Weight,
4. Name of the health facility or treatment centre,
5. Folder number (name or any local identification number that will help
identify the patient in case of follow-up) and telephone number of
patient or nearest contact person.
REPORTING “ADVERSE EVENT
OR ADVERSE DRUG REACTION
Information to be provided on the Reporting Form
Reaction Details
A detailed description of the suspected adverse drug reaction.
Information on dates of onset and stop of the reaction.
Outcome of the reaction (whether the patient has recovered,
not recovered or the outcome unknown).
Treatment provided for the adverse reaction (if any)
REPORTING “ADVERSE EVENT
OR ADVERSE DRUG REACTION
Details of the Suspected Product
The name(s) of the suspected medicine(s). Provide both the brand
and the generic names of the product, batch number, Manufacturer,
route of administration (if known) and daily dose. Attach separate
sheet in cases where there is more than one suspected product.
The date therapy was initiated and the date therapy stopped.
REPORTING “ADVERSE EVENT
OR ADVERSE DRUG REACTION
Details of the Suspected Product
Reason(s)/indication for use of the product should be
indicated.
Drugs taken within the last three months including
concomitant medicines and herbal remedies (if known)
should be provided.
REPORTING “ADVERSE EVENT
OR ADVERSE DRUG REACTION

Information to be provided on the Reporting Form

Reporter Details
The name and contact details of the reporter (phone number, e-
mail address and postal address) should be provided to enable the
National Pharmacovigilance Centre give feedback on the report
submitted or contact the reporter for follow up information when
needed. Additional information, not available at the time of the
initial report, should be provided in the form of follow-up reports.
 SPONTANEOUS REPORTING IN
PHARMACOVIGILANCE

Spontaneous reporting in pharmacovigilance is a passive process of

reporting suspected adverse drug reactions by healthcare professionals
or consumers to a relevant authority or organization .
It is a fundamental method of pharmacovigilance that helps to identify
and monitor the safety of medicines . Its main function is the detection
of new, rare, and serious ADRs , which remained undetected in the pre-
marketing clinical trials.
SPONTANEOUS REPORTING
Spontaneous reporting operates throughout a drug’s life,
starting from the day it is launched in the market. The
system also merits from the fact that it provides information
from real-life clinical practice as opposed to clinical trials
where vulnerable individuals are excluded and the duration
of treatment is limited. .
Causality assessment
Causality assessment is an important aspect of
pharmacovigilance that assesses the likelihood of suspected
adverse drug reactions (ADRs) caused by a particular drug. It
is the evaluation of the relationship between a drug
treatment and the occurrence of an adverse event.
Causality assessment helps identify and quantify risks
associated with drug use, which may influence regulatory
decisions, prescribing practices, and patient education
END OF LECTURE
THANK YOU