This presentation include the brief information regarding the Pharmacovigilance safety :Challenges and Perspectives. I had took part in one competition wherein I submitted this short essay on PV. This essay will give you a brief information about the PV process and it outcome, it will also reflect a light on the safety point of view

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Pharmacovigilance is concerned with only two outcomes: safety and efficacy. Does a drug work and
is it safe? It touches on almost every aspect of the drug lifecycle - from preclinical development to
post-market surveillance - making it one of the most fundamental functions within a life science
company.
Pharmacovigilance : also known as drug safety - is a broad term that describes the collection,
analysis, monitoring and prevention of adverse effects in drugs and therapies. It is a completely
scientific and process-driven area within pharma.
Why PV is Important?
Let’s take a example If you take any medication and you feel that this medication causes you
something unexpected and noxious response instead of its actual mode of action. So the problem here
is to whom you will report this and how you report this event. Then here comes the role of
Pharmacovigilance in news.
Similarly, there is a need to monitor the effects of drugs before and after it’s successfully tested and
launched in the market. Hence Pharmacovigilance play quite crucial role in overall drug safety an
efficacy performance.
The definition of an adverse event is any reaction within a patient’s body caused by a
drug/candidate molecule – a side effect. A serious adverse event is a life-threatening side effect that
causes hospitalisation, incapacity, permanent damage or, in extreme cases, the death of a patient.
Adverse event reporting is mandatory for all clinical research investigators, even if the side effects are
only suspected.
The role of pharmacovigilance is to determine which adverse events cross the line of a drug’s
efficacy. In other words, analysing which side effects are worth the risk to patients compared with
how effective they are at treating a disease. For instance, chemotherapy is known to cause some very
serious side effects but when faced with life-threatening cancer, these side effects are considered
acceptable given the potential to cure a patient. However, if a drug used to cure a headache caused
Pharmacovigilance safety: Challenges and Perspectives
Name: Gaurav Shriram Patil
Institute Address: H R Patel Institute of Pharmaceutical Education and Research, Shirpur.
Corresponding email address: gauravpatil2901@gmail.com
Contact No: +919665204828

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similar side effects, the risk to the patient would be considered too great and the benefit not
substantial enough to justify the potential damage.
Pharmacovigilance (PV) plays a consequential role in the drug regulatory system and is a constantly
evolving multifaceted field. In the process of carrying out its effective management, the PV system
does undergo a lot of challenges on a global pitch. PV system is well developed in the western globe
(United States, United Kingdom, Germany) while the east globe (e.g.: India) is still in the evolving
stage. Major discrepancies include different regulatory authorities for each nation with different forms
for ADR reporting and also different timelines. To mention a few; there is a regulatory gap because of
the continuously evolving regulations and business processes, it is difficult to comply with the diverse
regulations effectively; gross underreporting in the east as compared to the west; increased concern
about the safety and potential toxicity of traditional Chinese herbs in the east; self-medication;
linguistic barrier, etc. Steps like harmonization of regulation by drafting guidelines that are uniform
globally; leveraging digital technologies to optimize ADR reporting; meticulous and timely reporting;
inclusion of PV in the curriculum etc. can be employed. While PV has witnessed substantial
development over the years, areas of discrepancies need to be identified to build a seamless PV
system. Need for an effective revolutionary roadmap to tackle all the hindrances to fortify its
harmonious functioning.
Pharmacovigilance is regarded as the constant process of identifying the safe use of pharmaceutical
products and helps in minimizing the risk of any harm that may come to patients. Pharma Companies
must conduct a comprehensive drug safety and pharmacovigilance audit to assess their compliance
with worldwide laws, regulations, and FDA guidance.
Whereas pharmacovigilance frameworks have made significant advance within the past a few
decades, all pharmacovigilance frameworks confront a common set of continuous challenges in sedate
security reconnaissance in five central interrelated ranges: locks in the open, collaboration and
organizations, joining informatics, embracing a worldwide approach, and surveying the affect of
endeavors. In wide terms, these challenges are not unused. Or maybe, propels in science and
innovation, along side more requesting societal desires, have changed the nature of these challenges
and given modern openings to move the field forward. Contrasts in organization and levels of
improvement, as well as territorial contrasts, essentially suggest that a single approach isn't reasonable
for all locales, in spite of the fact that sharing of best hones can offer assistance each locale.
Following are few Challenges in Pharmacovigilance
The efforts of the PvPI have cut down the level of reluctance in reporting ADRs on the part of the
health professionals to some extent. However, reluctance in ADR reporting continues to be a real
bottleneck though to a less extent with time. This “reluctance” is significantly related to a lack of

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awareness among the health professionals who are primarily involved in reporting, monitoring, and
prevention of ADRs. Naturally, drug safety issues remain to be more vigorously pursued. Our own
study carried out in four medical colleges in Lucknow shows that a large proportion of the doctors
have inadequate knowledge about pharmacovigilance. To a marginally larger extent, attitudes too are
faulty. As far as the practices are concerned, even doctors with reasonable knowledge and attitudes
are lacking in sound practices. Several other studies have more or less similar findings with some
variations. We strongly feel that the PvPI needs to expand its scope of activities to widen its reach to
much larger healthcare professionalism with greater vigor and to strengthen measures for capacity
building.
ADR Reporting: Practical Considerations
All wellbeing experts, particularly specialists and medical attendants, must be touchy to the discovery
of ADRs and their announcing suitably. The PvPI empowers detailing of all suspected drug-related
antagonistic responses, counting antagonistic occasions related to antibodies and responses suspected
to have been caused by home grown, conventional, or elective cures. Indeed the announcing of clearly
minor and inconsequential or common antagonistic responses is vital. The data given within the
submitted frame is analyzed for “causality” at AMCs by utilizing the WHO-UMC scale. From there
on, the analyzed shapes are sent to the NCC through the ADR database within the last step, the
information are analyzed and sent to the Worldwide Pharmacovigilance Database overseen by WHO
Uppsala Observing Middle in Sweden.
Inconsistent reporting of Adverse events
The occurrence of an adverse event is not always during a visit to the Healthcare Center. It can occur
after severalhours of administering the drug. Patients fail to remember all the relevant information
about the adverse events and are not able to report it accurately.
Patients are anxious and report all their discomfort as adverse events. Adverse drug events (ADE)
reported are not always serious and may be symptoms of a disease. Other incidents where a patient
has not followed instructions during medication or the patient has had side effects caused by
concomitant medicines taken along with the study drug could be reported as adverse events. Such
wrong reporting can lead to drug safety committees to incorrect conclusions which in turn lead to the
suspension or withdrawal of drugs.

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Challenges in Spontaneous reporting
Adverse events can be reported voluntarily by the patient, companies, or the HCP. The major
drawback of the system is the under-reporting of adverse events to the post-marketing databases. The
medical staff does not prioritize reporting and may neglect symptoms that are not serious.
Data analysis may produce more signals than that can be analyzed from the available resources. The
adverse event workload has been rising to more than 50% yearly in a few companies. This might
delay the focus on potential serious adverse events requiring immediate action.
Another concern is the misreporting and miscoding of adverse events. The fields in reports about
dosage, formulation type, time and length of exposure to adverse events are not clearly reported and
coded leading to challenges in managing and analyzing the data.
This also leads to the generation of false alarms for non-existent adverse events. HCP’s generally
select treatments based on their own practice preferences; also the inadequately adjusted algorithms
could produce errant false signals. Inadequate analysis of such signals may lead to early refusal of
useful drugs.
Priority of efficacy over safety
Smaller drug companies may prioritize efficacy over safety in clinical trials leading to a compromise
in drug quality. The signal detection is not utilized by few sponsors to detect and effectively solve the
issues in a timely manner. Drug development relies on balancing efficacy and safety equally.
Limitations in Published case reports
Reports in medical journals about the suspected adverse effects are an established way to alert about
drug hazards. These reports are one of the signal generating reports easily accessible by the general
population. Limitations in these include:
 A small number of cases are published.
 Reports are poorly documented.
 Delay in occurrence and publication of adverse events.
Challengesin Pharmacovigilance during Covid-19
To contain the spread of the infection, nations all around the world forced total or halfway lockdowns,
which lead to the closure of offices for Pharmacovigilance experts. This brought about in a alter of
schedule reviews and security review exercises, which moreover influenced the sum of work relating to

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non-Covid items. The influx of data and information on non-Covid items saw a unfaltering decay as a
result of lesser visits to the healing centers and a uncovered least center on other pathologies. Another
enormous challenge in guaranteeing normality and proficiency in operations is the diminished pool of
experts owing to social removing and isolate standards. The need of get to to ADR observing centres and
a diminished pool of human assets in Pharmacovigilance has made announcing and collection of
information at the same speed a monotonous assignment.
As the challenges within the confront of the seething widespread surface, the openings must be seized
and solutions capitalized upon to play down misfortunes. Regardless the situation of the widespread, the
Pharmacovigilance framework has been adjusted with healthcare laborers in a way to form it more
patient-centric.
Pharmacovigilance safety perspectives
community and hospital pharmacists can play an important role in ADR reporting, a number of
studies have been conducted globally to evaluate knowledge, attitudes, and practices of pharmacists
toward ADR reporting with an aim to identify knowledge, attitudes, practices, and barriers to ADR
reporting, so that appropriate interventions can be designed and implemented to overcome these
barriers. However, a number of barriers to ADR reporting experienced by pharmacists. Broadly, these
barriers can be classified as health system-related barriers and individual pharmacist-related barriers.
Although a number of these barriers are interrelated, this broad classification is made just for ease of
comprehension and to identify potential target areas for interventions aimed at improving ADR
reporting rates. The most commonly reported barrier is the lack of knowledge about local reporting
guidelines and policies and establishing ADR causation with suspected drug. Another well-
documented misconception among pharmacists is to report only serious and/or new ADRs.
Perspective ofundergraduate pharmacy students regarding Pharmacovigilance
It is imperative to ensure that pharmacy students, the future pharmacists, are well trained and have
sufficient knowledge pertaining to procedures and importance of ADR reporting. They should be able
to recognize, prevent, and repot an ADR. There are nine studies exploring the pharmacy students’
perspectives in PV and ADR reporting. Therefore, a number of studies have evaluated perspective of
pharmacy students toward PV and ADR reporting.
A number of studies have evaluated perspective of pharmacy students toward PV and ADR reporting.
In general, most studies reported that the pharmacy students had insufficient knowledge in PV or
ADR reporting.
Pharmacy students generally expressed a positive attitude toward PV and ADR reporting.

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The majority of the surveyed pharmacy students agreed that PV is crucial, and all health care
professionals including pharmacists should actively report ADR in their daily practices.
Most believed that by reporting ADR can educate others about the risk of the drugs, improve patient
safety, and it is personally rewarding.
The road to the Pharmacovigilance safety: Challenges and Perspective is really challenging in so
many ways. The globe is expected to be work in collaboration to solve the major issues, and work
accordingly to face the challenges. The Pharmacovigilance safety thing is going to be the next big
thing happen in the era of healthcare sector. It really very helps the healthcare sector at its best and for
the sake of community.