Suez Canal University

Faculty of Pharmacy
MBA
Dr. Aliaa Osman
Head of Clinical Pharmacy Unit- Ain Shams University Specialized Hospital
Lecturer of Clinical Pharmacy and Pharmacy Practices
Sinai University
 Pharmacovigilance
Pharmacovigilance is the science and activities relating to the detection,
assessment, understanding and prevention of adverse effects or any
other medicine/vaccine related problem.
 Introduction
Pharmacovigilance is the beating heart of pharmaceutical production.
Purpose:
Pharmacovigilance (PV) is designed to protect patients and enable the dissemination of
knowledge amongst professionals to minimize the risk of adverse events.
Without it, there would be no way to assess the effectiveness of drugs in comparison to their
side effects.
Definition:
According to the WHO pharmacovigilance is defined as:
“The science and activities relating to the detection, assessment, understanding and prevention
of adverse effects or any other drug-related problem.”
• Essentially, it is drug safety. Pharmacovigilance ensures that all medicines and
vaccines undergo rigorous testing for safety and efficacy through clinical trials
before they are authorized for use.

• Present throughout the drug lifecycle, PV certifies whether a drug works and if it
is safe to use.

• However, the clinical trial process involves studying these products in a relatively
small number of selected individuals for a short period of time.

• Certain side effects may only emerge once these products have been used by a
heterogeneous population, including people with other concurrent diseases, and
over a long period of time.
What is an adverse event?
• An adverse event is a negative reaction caused by taking a drug, more commonly
known as a side effect, which is not that accurate.
• As a side effect is an event related to drug pharmacology and can be well expected on
using a certain drug.
• While an adverse drug reactions are a response that is noxious and unintended and
that occurs at doses normally used in humans for the prophylaxis, diagnosis or
therapy of disease or for modifying physiological function.
• They may vary in presentation and occurrence and are commonly divided into type A
(augmented pharmaceutical response) and type B (bizarre or hypersensitivity)
adverse drug reactions.
• An example of a type A reaction in relation to antiretroviral (ARV) drugs for

treating HIV is the negative effect of Tenofovir on bone mineral density, which

may increase fracture risk. An example of a type B reaction is Efavirenz-related

hypersensitivity in the form of a skin rash with systemic symptoms.

• In summary adverse events can include any unexpected or unwanted symptoms

experienced by the patient, including temporary reactions and those previously

not associated with that drug.

• A serious adverse event is a reaction that causes life-threatening

harm to the individual, resulting in hospitalization, significant

disability or incapacitation, congenital abnormality, or at worst,

death.

• Anything that requires intervention to prevent these is also classified

as serious.

• In any case, adverse event reporting is compulsory and critical to the

success of PV.
Evolvement of Pharmacovigilance
• While it may seem obvious to thoroughly test and monitor the safety of drugs, the process
wasn’t formalized until the 1960s after the infamous thalidomide incident. Introduced in 1957,
thalidomide was used as a sedative for sleeplessness and was deemed safe for use by pregnant
women. The drug also seemed to alleviate morning sickness, so quickly became popular among
expectant mothers.

• Fast forward to 1962 and the true effects of the drug were revealed. It was proven to be a
teratogen, responsible for the deformity of thousands of children. As a result, new stringent
testing laws were introduced and evolved into what we now know as pharmacovigilance.
• PV is absolutely crucial during the clinical research phase of drug
development to ensure it is safe for distribution, but it is also vital to
continuously monitor the drug.

• Post-market safety monitoring is the only way to get an accurate picture

of a drug’s safety and ensure adverse events are properly reported for
review, for instance through the FDA’s Medwatch gateway or The
Egyptian PV Program.
Importance of Post-marketing PV
• The role of pharmacovigilance is to assess whether the benefits of a drug
outweigh the risks and it doesn’t stop after the drugs are certified. PV involves
ongoing monitoring of drugs to ensure they remain safe for use, especially since
previously undetected adverse events can occur at any time.

• In fact, there are several reasons why clinical trials may not uncover every
possible side effect. The number of people who receive the drug in a trial will be
a relatively small number in comparison to general distribution, so it is likely
additional reactions will happen.
• What’s more, clinical trials are actively controlled to protect high-risk
patients, so certain groups such as the elderly may not be involved in
the trial but may be prescribed the medication for general use.

• Monitoring of the drug may also be less strict once it is certified,

which will inevitably introduce more variables (use in various age
groups or with some co-morbidities).
PV Future Prospects
• Historically, pharmaceutical companies have controlled the generation and
distribution of information about their range of products. However, the rapid
pace of innovation and adoption of consumer health technologies in the form of
wearables, sensors and digital services has weakened this control.

• The use of digital technologies offers pharma companies the opportunity to

deliver a step change in the efficiency, speed and quality of pharmacovigilance
programes.
• The combination of patient-generated health data with datasets held by healthcare providers

and machine learning models offers pharmaceuticals the opportunity to generate new insights

at a pace and scale that has not been possible in the past. These insights extend not only to

drug safety and efficacy, but also to quality of life indicators that can support drug use at a

community scale.

• To exploit this opportunity, pharmaceutical companies will require new digital infrastructure to

collect and aggregate this patient-generated health data at scale while ensuring that patient

consent is respected.
The key goals
of PV can be
summarized in
the opposite
figure.

Fig. 1 : Key Goals of PV

Pharmacovigilance Life Cycle:
• Timeline of pharmacovigilance for a drug from development (pre-market) to post-marketing
use
1- Pre-market research and development
• Preclinical animal toxicity
• Clinical Phase I
• Clinical Phase II
• Clinical Phase III

2- Regulatory review and approval

3- Post-market /real world Use

• Pricing and cost-effectiveness
• Accessing benefit–risk and risk management activities
• pre- and post-marketing data assessment
• The PV module on trial design covers issues concerning efficacy and safety data
from Phase I to III studies, including the implications of relatively short follow-up
times in drug approval trials and restricted entry criteria into trials.

• Post-marketing PV can be conducted through passive and active surveillance

systems.

• In passive surveillance, health-care professionals or patients send spontaneous

reports describing an adverse drug reaction after one or more medicinal products
are administered to the marketing authorization holder or regulatory authority.
• Sometimes such first case reports are published, which may stimulate
subsequent reporting. An example is the case report of Efavirenz-
induced gynaecomastia in a prepubertal girl with HIV, published in
2013.

• A case series is a series of such reported cases, and these can help to
generate hypotheses about an association between drug exposure and
an outcome. An example is the case series of gynaecomastia cases
reported to the National HIV & Tuberculosis Health Care Worker Hotline
in South Africa and published in 2016.
• Active surveillance involves enhanced or targeted monitoring for certain events

or drugs and seeks to ascertain completely the number of adverse drug reactions

through a pre-planned process.

• Active surveillance is also commonly known as toxicity monitoring (such as the

WHO anti-retro virus (ARV), program) or safety monitoring . An example is a

cohort study that evaluated the prescribing of, adherence to and adverse drug

reactions associated with antiretroviral therapy (ART) in a large program in Lagos,

Nigeria.
•In the figure below (Fig. 2) the aims and key
workers behind PV are illustrated.

•These will be further discussed.

Aims

Key Players of PV
Fig. 2: the aims and key workers behind PV
Thank You