INTRODUCTION
Pharmacovigilance is an important and integral part of clinical research. Both clinical trials safety and post
marketing pharmacovigilance are critical throughout the product lifecycle. Pharmacovigilance is “defined as the
pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects,
What do we know of its benefits and risks, challenges and the future hold for pharmacovigilance in Indian
medicine. Here the main focus on the aims and role of pharmacovigilance in medicines regulation and their
Partners. particularly long term and short term adverse effects of medicines.” Pharmacovigilance is still in its
infancy in India and there exists very limited knowledge about the discipline. While major advancements of
discipline of pharmacovigilance have taken place in the western countries much has been achieved in India.
Pharmacovigilance is not new to India and has in fact been going on from [Link] India decided to join the
uppaslacentre for adverse event monitoring. The importance of pharmacovigilance is withdrawls the regulatory
agencies, media; consumers have become more aware about the benefit and risks of medicines. “An adverse event
is defined as any un toward medical occurrence that may present during treatment with a drug but which does not
necessarily have a relationship with its use.” “An adverse drug reaction is any noxious, unintended and undesired
effect of a drug, which occurs at a dose used in human for prophylaxis, diagnosis, therapy or modification of
physiological function.” Spontaneous reporting of adverse drug reaction and adverse events is an important tool
for gathering the safety information for early detection. In recent years many Indian companies are increasing the
investment in research and development and are enhancing their capacity to develop and market new drugs with
their own research efforts. In 2008, this is really recent data and has been used here since most recent and relevant
data available are of this year. Available, it was estimated that (ADRS) accounted for 5% of the total amount of
reports, thus minimizing the number of times that honest adverse reaction reports were being eliminated. It
accounts for about 200,000 hospitalizations and about 197,000deaths per year in European union (EU) and its
therefore they attract societal cost of €79 billion.
HISTORY AND PERSPECTIVE OF PHARMACOVIGILANCE
Thalidomide :
The decisive event for the birth of pharmacovigilance occurred in 1961 when the use of thalidomide during
pregnancy caused a 20% increase in congenital malformations in newborns. The drug was tested for two years on
300 patients, without detecting any particular side effects. Therefore, considered safe, it was marketed in over 50
countries starting from 1957. Thalidomide was used primarily as a sedative, antiemetic and hypnotic in pregnant
women. Its administration caused a serious anomaly in the development of the foetus: the newborns had serious
deformities of the limbs, especially the upper ones, such as the absence (amelia) or reduction of the bones
(phocomelia). Approximately 10,000 to 20,0000 children suffered incomplete development. In 1977, the united
states food development authority established what is known as the adverse drug reaction reporting system forcing
drug producers to report any side effects related to their products.
Chloroform :
The history of pharmacovigilance dates back to 1848, when a series of suspicious deaths occurred in great britain
during operations in which chloroform was administered to patients. chloroform was used as an anesthesia starting
in 1847. The following year a 15-year-old girl died following its use. This tragic event sparked concern, prompting
the lancet journal to set up a commission and urge british doctors to report similar cases. A debate therefore opened
on the safety of anesthesia procedures and following various reports, the drug ceased to be used as an anesthesia
in 1976. This episode represented the first step towards the establishment of pharmacological safety procedures.
Sulfanilamide :
Most consequential mass poisonings of the 20th century. Sulfanilamide an antibacterial drug, was being used
safely in the treatment of streptococcal infection a new elixir the elixir sulfanilamide disaster of 1937 was one of
the formulation with raspberry flavour was prepared using diethylene (deg) as there was a need for the drug in its
liquid form. Deg can be fatal, and unknowingly the company distributed the product across the united states.
However, the food and drug regulation (at that time) did not insist on oxicity studies for the new formulation.
Hence, the company did not carry out any toxicity studies. Soon after its appearance on the market, the American
medical association was made aware of the lethal cases from the administration of this elixir, and though
immediate attempts were made to recall it, many died. The elixir was produced by a us pharmaceutical company,
s. E. Massengill company. The formulation resulted in the death of 105 patients who consumed the elixir. In
reaction to this calamity, the us congress passed the 1938 federal food, drug and cosmetic (FAC) act, which
required proof of safety before the release of a new drug. The 1938 law changed the drug focus of the food and
drug administration (FDA).
ROLE OF PHARMACOVIGILANCE
Pharmacovigilance has been widely accepted to possess a significant role in early observation of the risk
associated with the drug. All the medicines are tested on a concerned small ratio of population before it is approved
for post-marketing surveillance. The pharmacovigilance has been known to possess various roles like,
identification, quantification and documentation of drug-related problems; contribution towards reducing the risk
of drug-related problems in healthcare systems; and enhancement of knowledge and understanding of factors and
mechanisms which are responsible for drug-related injuries. However, in order to fill the various roles of
pharmacovigilance, the interactions and influence of many stakeholders in society with decision-making powers
has been required, which include, politicians at national, regional and local levels; healthcare administrators; drug
regulatory authorities; pharmaceutical companies; healthcare professionals like physicians, dentists, pharmacists
and nurses; academic institutions; media representatives; health insurance companies; lawyers; and patient group.
Associated with marketed medicines. Other important followers of pharmacovigilance are the health
professionals: Originally physicians were the only professionals who observe different kinds of drug related
problems by exercising the skill of differential diagnosis. Last of all, the patients form the most important adherent
of pharmacovigilance as, a patient knows the actual benefit and harm of a medicine prescribed to him. Vaccines
and biological medicines require modified systems of safety monitoring. They are often administered to healthy
children. This applies particularly to vaccines used within a national immunization program.
CURRENT METHODS OF PHARMACOVIGILANCE
Spontaneous Reports :
Spontaneous reports are so-called because they arise during a clinician's normal diagnostic appraisal of a patient,
the clinician drawing the conclusion that a drug may be implicated in the causality of the clinical event. As with
all diagnoses the certainty of attribution will vary with the skill and experience of the doctor, what confirmatory
tests may show, the natural history of the clinical event, and the existence of other plausible explanations. Under-
reporting, reports of known reactions, and false causality attribution are the common criticisms of spontaneous
reporting systems.
Targeted Clinical Investigations :
Over-all Pharmacovigilance Methods :
Figure 1: Drug development Process
Targeted clinical investigation - When significant risks are identified from pre-approval clinical trials, further
clinical studies might be called for to evaluate the mechanism of action for ADRs This investigation includes- >
PK and PD studies > Genetic testing >Interaction studies > Large simplified trial.
Pk and Pd Studies :
Pharmacodynamics is the study of how a drug affects an organism, whereas pharmacokinetics is the study of how
the organism affect the drug. Pharmacodynamic and pharmacokinetic studies are conducted to determine whether
a particular dosing instruction can put patients at an increased risk of adverse events.
Drug-Drug- Interaction of PD and Pk Studies :
Drug- drug interactions occur when a drug interacts , or interferes, with another drug. This can alter the way one
or both of the drugs act in the body, or cause unexpected side effects. Aspirin + Warfarin Synergism (excessive
bleeding Antibiotic + Blood thinner Antagonism (less effect) Codeine + Paracetamol Addition (increased
analgesic effect).
Co-hert Studies :
He term “cohort” is derived from the Latin word cohors. Roman legions were composed of ten cohorts. During
battle each cohort, or military unit, consisting of a specific number of warriors and commanding centurions, were
traceable. The word “cohort” has been adopted into epidemiology to define a set of people followed over a period
of time. W.H. Frost, an epidemiologist from the early 1900s, was the first to use the word “cohort” in his 1935
publication assessing age-specific mortality rates and [Link] modern epidemiological definition of the
word now means a group of people with defined characteristics who are followed up to determine incidence of,
or mortality from, some specific disease, all causes of death, or some other outcome.
Longitudinal Electronic Studies :
Collections of longitudinal electronic patient records are extremely valuable but underused in analysing real-world
use of medicines. They cover large populations, provide detailed information on extended parts of medical
histories and include information on both exposed and unexposed patients. The range of clinical information
available may include prescriptions, laboratory test results, hospital referrals and admissions, and notes on
symptoms, signs and diagnoses. Ideally, anonymised information is extracted directly from the computer systems
in which physicians store patients‟ data, so that no extra effort is required to provide the information and the risk
of omissions is minimised. Privacy protection for patients and physicians is of the utmost importance and needs
to be carefully controlled. In the UK, general practitioners‟ records provide an important source of information
and have formed the basis of the General Practice Research Database, i.e., reports on adrs that are not solely
triggered by the expertise and suspicion of a medical expert, but also influenced by other factors, e.g., extensive
media coverage of newly suspected adverse reactions after exposure to a certain drug.
Figure 2 : Longitudinal data
Screening Patient Records :
Patient records are already an important resource for confirmatory pharmacoepidemiology studies. In recent years
interest has increased in extending their use to exploratory analysis and routine drug surveillance. Many methods
focus exclusively on one specific aspect of the drug-event association, such as the time from first exposure to the
medicine to the first occurrence of the event or differences in the frequencies of the event in the same patients
when exposed and unexposed. However, there is great variation in temporal patterns of potential interest,
including those related to.
• Suspected ADRS
• Potential beneficial effects of medicines
• Events related to the underlying disease
• Periodic patterns and trends, and
• Medical events that are generally common in exposed patients.
Figure 3 : Sampling of Patients Screened Using Spirit
ADVERSE EVENT CASE PROCESSING :
Introduction :
Registries that collect information on specific drugs and medical devices need to anticipate the need for adverse
event (AE) detection, processing, and reporting. This chapter addresses the identification, processing, and
reporting of adverse events detected in situations in which a registry has contact with individual patients. This
document is not a formal regulatory or legal document; therefore, any information or suggestions presented herein
do not supersede, replace, or otherwise interpret Federal guidance documents that touch on these subjects. Registry
sponsors are encouraged to discuss plans for AE collection and processing with local health authorities when
planning a registry. This chapter primarily focuses on adverse events related to pharmaceutical products. Medical
devices are significantly different from pharmaceutical products in the manner in which adverse events and
product problems (complaints) present themselves, in the etiology of their occurrence, and in the regulation
governing the defining and reporting of these occurrences, as well as post approval study requirements. Other
sources provide more information about defining and reporting device-related adverse events and product
problems, and about post marketing studies (including those involving registries). In pharmacovigilance, case
processing is a fundamental activity. It provides data for the analysis of adverse effects that allows to detect new
safety concerns and to periodically assess the benefit-to-risk ratio associated with the use of a pharmaceutical
product. The precision and quality of safety data processing, also from the medical point of view, is crucial for
ensuring correct analysis and undertaking corrective actions in a timely manner, which in turn helps to safeguard
the health of the patients and allows safe use of the drug. Or post approval studies financially sponsored by
manufacturers.
Figure 4 : Sources of individual (adverse event) case safety reports
Sources of Individual Case Safety Reports :
UNSOLICITIED SOURCES :
Spontaneous Reports
An unsolicited communication by a healthcare professional or consumer to a company, regulatory authority or
other organization (e.g. WHO, Regional Centre, Poison Control Centre) that describes one or more adverse drug
reactions in a patient who was given one or more medicinal products and that does not derive from a study or any
organized data collection scheme‟(ICH 2003). Spontaneous reporting is by nature a passive approach to
pharmacovigilance (PV), relying entirely on the motivation of individuals to report suspected adverse drug
reactions (ADRs) to a local or national pharmacovigilance centre. Spontaneous reporting systems (SRS) can be
paper based (e.g. The UK ‘Yellow Card’ system) or electronic (online reporting or mobile applications). Single
reports from individual patients submitted to pharmacovigilance centres via these systems are known as Individual
Case Study Reports (ICSRs). Information from multiple ICSRs is then used to identify potential „signals‟–
suggestions of casual associations between a medicinal product and a previously unknown reaction. Detection
and confirmation of these signals, though various methods, can identify previously unknown adverse or beneficial
effects of a medication.
SOLICITED SOURCES:
Solicited reports are those derived from organized data collection systems, which include clinical trials, registries,
post-approval named patient use programs, other patient support and disease management programs, surveys of
patients or healthcare providers, or information gathering on efficacy or patient compliance. Adverse event reports
obtained from any of these should not be considered spontaneous. For the purposes of safety reporting, solicited
reports should be classified as study reports, and therefore should have an appropriate causality assessment by a
healthcare professional or an MAH. Further guidance on study-related issues, such as managing blinded therapy
cases, can be found in the ICH E2A guideline.
Regulatory Authorities as the Sources :
Individual serious unexpected adverse drug reaction reports originating from foreign regulatory authorities are
subject to expedited reporting to other authorities by each MAH. Re-submission of serious ADR cases without
new information to the originating regulatory authority is not usually necessary, unless otherwise specified.
STANDARDS FOR EXPEDITED REPORTING :
What Should Be Reported ?
Serious ADRs Cases of adverse drug reactions that are both serious and unexpected are subject to expedited
reporting. The reporting of serious expected reactions in an expedited manner varies among countries. Non-serious
adverse reactions, whether expected or not, would normally not be subject to expedited reporting. For reports
from studies and other solicited sources, all cases judged by either the reporting healthcare professional or the
MAH as having a possible causal relationship to the medicinal product would qualify as ADRs. For purposes of
reporting, spontaneous reports associated with approved drugs imply a suspected causal relationship.
Other Observations:
In addtion to single case reports, any safety information from other observations that could change the risk-benefit
evaluation for the product should be communicated as soon as possible to the regulatory authorities in accordance
with local regulation. Examples include any significant unanticipated safety findings from an in vitro, animal,
epidemiological, or clinical study that suggest a significant human risk, such as evidence of mutagenicity,
teratogenicity, carcinogenicity, or lack of efficacy with a drug used in treating a life-threatening or serious disease.
Lack of Efficacy :
Evidence of lack of efficacy should not normally be expedited, but should be discussed in the relevant periodic
safety update report. However, in certain circumstances and in some regions, individual reports of lack of efficacy
are considered subject to expedited reporting. Medicinal products used for the treatment of life-threatening or
serious diseases, vaccines, and contraceptives are examples of classes of medicinal products where lack of efficacy
should be considered for expedited reporting. Clinical judgment should be used in reporting, with consideration
of the local product labeling and disease being treated.
Overdose :
Reports of overdose with no associated adverse outcome should not be reported as adverse reactions. Cases
associated with serious adverse reactions are considered subject to expedited reporting, unless otherwise specified
by local regulation. They should be routinely followed up to ensure that the information is as complete as possible
with regard to symptoms, treatment, and outcome. The MAH should collect any available information on overdose
related to its products.
Minimum Criteria for Reporting :
It is recommended that as much information as possible be collected at the time of the initial report. However, for
the purpose of regulatory reporting, the minimum data elements for an ADR case are: an identifiable reporter, an
identifiable patient, an adverse reaction, and a suspect product. Lack of any of these four elements means that the
case is considered incomplete; however, MAHs are expected to exercise due diligence to collect the missing data
elements.
ADR REPORTING :
What to Report PVPI encourages all types of suspected ADRs reporting whether they are known, unknown,
serious, or non-serious , frequent, or rare regardless of an established causal relationship between a drug and the
reaction. ADRs related with the use of allopathic medicines, vaccines, traditional medicines, medical devices,
contrast media, etc. can be reported.
Where to Report :
All healthcare professionals (clinicians, dentists, pharmacists, nurses) and patient/consumers can report ADRs to
NCC or AMCS. The pharmaceutical companies can also send individual case safety reports for their product to
NCC.
How to Report :
Suspected ADR reporting forms for healthcare professionals and consumers are available on the website of IPC
to report ADR. To remove language barrier in ADR reporting, the consumer reporting form are made available in
10 vernacular languages (Hindi, Tamil, Telugu, Kannada, Bengali, Gujarati, Assamese, Marathi, Oriya, and
Malayalam). ADRs can he also reported via PvPI helpline number (18001803024) on weekdays from 9:00 am to
5:30 pm. The mobile Android application for ADR reporting has also been made available to the public.
Lack of Efficacy :
Evidence of lack of efficacy should not normally be expedited, but should be discussed in the relevant periodic
safety update report. However, in certain circumstances and in some regions, individual reports of lack of efficacy
are considered subject to expedited reporting. Medicinal products used for the treatment of life-threatening or
serious diseases, vaccines, and contraceptives are examples of classes of medicinal products where lack of efficacy
should be considered for expedited reporting. Clinical judgment should be used in reporting, with consideration
of the local product labeling and disease being treated.
Overdose :
Reports of overdose with no associated adverse outcome should not be reported as adverse reactions. Cases
associated with serious adverse reactions are considered subject to expedited reporting, unless otherwise specified
by local regulation. They should be routinely followed up to ensure that the information is as complete as possible
with regard to symptoms, treatment, and outcome. The MAH should collect any available information on overdose
related to its products.
Whom to Report :
A reporter can send filled ADR reporting form directly to NCC or their nearest a Arthrogryposis multiplex
congenita (AMC). In case of AMC, these reports are confirmed by healthcare professionals and entered into
Vigiflow and sent to NCC for further assessment. These reports are then finally reviewed at NCC and committed
to WHO-Uppsala Monitoring Centre. The obtained information is entered in the drug safety database, analyzed,
and assessed by the experts to identify new signals. The submitted ADR report does not have any legal implication
on the reporters. The patients' identity are held in strict confidence and protected to the fullest extent. Therefore,
healthcare providers are encouraged to report ADRs for better understanding of the risk associated with the use
of medicines and to safeguard the health of Indian population.
What Should be Reported :
Patient Related Details :
1. Patient details
2. Sex
3. Weight
4. Age at time of reaction or date of birth
Medicine :
1. Name (INN and brand name)
2. Strength
3. Dose, frequency
4. Dosage form
5. Route of administration
6. Indication for use
7. Duration of use
8. Batch number
Suspected Adverse Reaction :
1. Description of the reaction
2. Expectedness of the reaction
3. Date the reaction started, stopped
4. Outcomes
5. Relevant tests / laboratory data
Reporter's Details :
1. Name initials
2. Address
3. Contact details
4. Qualification Above information should be reported during ADR reporting.
Post Marketing Surveillance :
Post marketing surveillance (PMS) of medications is the process by which marketed medicines are monitored for
adverse drug reactions (ADRs) post clinical trials.1Since most drugs may not reach the market without passing
phase III clinical trials, PMS studies are considered to be phase IV studies. The safety and efficacy evaluations of
any new medicinal product via clinical trials will provide only limited information on rare ADRs. In addition,
discovering „rare‟ (1 in 1000) and „very rare‟ (1 in 10,000) ADRs usually occurs only in the post marketing
phase. This is mainly due to the limited variety of conditions, described as the „five too: too few, too simple, too
narrow, too median-aged and too brief, referring to the narrow patient selection criteria and sample size along
with the short duration of clinical studies. This makes it challenging to attain all the required safety data when
relying exclusively on such studies. PMS gives more realistic results as they occur in a more natural setting and
afford evidence to safeguard or enhance the safety of approved drugs. As a result of PMS, almost 20% of new
medications obtained a black box warning post marketing, and 4% were removed from the market due to safety
concerns. An ADR is defined by the World Health Organization (WHO) as: „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 modification of physiological function‟ Each year, millions of patients experience ADRs,
especially with the increased use of medicinal drugs. From 2009 to 2012, approximately 47% of people in the
United States reported using no less than one prescription medication in the past month and approximately 11%
reported using no less than five prescription medications concomitantly. As a result, the amount spent on
prescription drugs was estimated to be US$270 billion in 2013 according to the National Centre for Health
Statistics report in [Link] and his colleagues estimated, in a landmark meta-analysis in 1998, that ADRs
were associated with over 2,216,000 hospitalization cases annually in USA (admitted because of ADR or suffered
ADR while in hospital), leading to more than 106,000 deaths each year. Therefore, ADRs take the place as the
fourth to sixth major cause of death, eclipsing pulmonary disease, diabetes, acquired immune deficiency syndrome
and pneumonia. According to the Centres for Disease Control and Prevention, ADRs are responsible for almost
1,300,000 emergency department visits annually.
Post Marketing Surveillance of Suspected ADRs:
Post marketing drug monitoring actions deal with two pharmacology fields: pharmacovigilance and
pharmacoepidemiology. Pharmacovigilance, also known as drug safety surveillance is mainly concerned with the
timely detection of novel ADRs that are unique in their clinical nature, severity and/or frequency.
Pharmacoepidemiology represents the population based study of drug uses and the risks associated with these
uses‟. The significance of using pharmacovigilance should be encouraged by highlighting that the life of a drug
truly starts post marketing . Nowadays, PMS can be conducted actively, due to technological progress, with the
help of computer systems and electronic medical records. This can be achieved when the regulatory authorities,
as well as the pharmaceutical companies, have access to electronic medical records database and seek drug-
associated ADRs. Three of the main limitations of pharmacovigilance are: under- reporting, difficulty in
identifying low risks, and the difficulty or impracticality of quantifying risks. Moreover, ADR reporting is
determined by numerous factors, for example how serious or severe an ADR is, how long the drug has been on
the market, the experience of the health care professional, and the qualifications of the reporting physician
(specialists report more often than general practitioners do). Nevertheless, spontaneous reporting is still the basis
of post marketing drug safety surveillance. The fact remains that the main source of data collection for post
marketing pharmacovigilance since the 1960s is spontaneous reporting systems (SRSs). They are considered to
be a passive approach and are composed of reports of suspected ADRs gathered spontaneously from healthcare
professionals, consumers and pharmaceutical companies that are maintained for the most part by regulatory health
agencies. As such, PMS is applied in passive national reporting schemes, for example, Yellow Card Scheme‟ in
the United Kingdom and MedWatch in the United States. It is also applied as active surveillance by Medicines
and Healthcare products Regulatory Agency (in the UK) and the U.S. Food and Drug Administration (US FDA),
which carries out post marketing surveys. Due to technological progress, with the help of computer systems and
electronic medical records. This can be achieved when the regulatory authorities, as well as the pharmaceutical
companies, have access to electronic medical records data base and seek drug-associated ADRs. Three of the main
limitations of pharmacovigilance are: under-reporting, difficulty in identifying low risks, and the difficulty or
impracticality of quantifying risks. Moreover the fact remains that the main source of data col lection for post
marketing pharmacovigilance since the 1960s is spontaneous reporting systems (SRSs). They are considered to
be a passive approach and are composed of reports of suspected ADRs gathered spontaneously from healthcare
professionals, consumers and pharmaceutical companies that are maintained for the most part by regulatory health
agencies. As such, PMS is applied in passive national reporting schemes, for example Yellow Card Scheme in the
United Kingdom and MedWatch in the United States. It is also applied as active surveillance by Medicines and
Healthcare products Regulatory Agency (in the UK) and the U.S. Food and Drug Administration (US FDA),
which carries out post marketing surveys. They also proposed for important potential adverse reactions that post
marketing intervention studies should be proactively planned and conducted using a control group to identify the
degree of risks. Performing PMS studies only in certain medical journals. Therapeutic Advances in Drug Safety
institutions with quality systems can present another potential solution. With such efforts, post marketing safety
data can be collected in a better and more efficient way to enhance patient safety.
Spontaneous ADR Reporting System :
Spontaneous ADR reporting systems are important since they are a cost-effective method that can lead to the
detection of new or rare ADRs. Spontaneous reports are collected in databases through different channels
(pharmaceutical companies, national and international pharmacovigilance centres or regulatory authorities).
These databases belong to different institutes, such as US FDA and EMA, through which ADRs are collected and
exchanged. Following analysis of the spontaneous reports, signals of unidentified or potential ADRs are
generated.
Minimum Awareness of Spontaneous ADR Reporting Systems:
A study done in Korea on a selected sample from the general population showed that the awareness of an ADR
reporting system was quite low, at 8.3%. The main source of information was television/radio (69.9%), then the
internet (19.3%), while only 6.1% obtained the information from posters or brochures. These findings indicate
that awareness of the importance of ADR spontaneous systems should be boosted by campaigns, to emphasize
the importance of this subject. A cross-sectional study done in Ghana on randomly selected doctors showed that
less than 30% of the selected doctors were trained in the spontaneous ADR reporting system.
Future Prospects of Pharmacovigilance:
Pharmacovigilance has clear, well-established goals: to detect ADRs associated with the use of drugs as early as
possible, and to avoid risks that may outweigh the benefits of the medication. The evolution of pharmacovigilance
has been a slow and steady one.[47] From individual doctors noticing unusual effects in patients and sharing their
findings with colleagues to the methods used today to monitor a drug after its release into the market, including
spontaneous reports, risk management plans, prospective safety studies, and registries. The main focus of
pharmacovigilance has been to detect rare ADRs while giving less attention to the common ones. Recently,
however, there has been a climate of change and efforts are now being made to focus on patient-centred
pharmacovigilance rather than population-based and regulation-based pharmacovigilance. A study was conducted
to evaluate the different aspects of pharmacovigilance currently, and in the future.
CONCLUSION:
Pharmacovigilance continues to play a crucial role in meeting the challenges posed by the ever increasing range
and potency of medicines, all of which carry an inevitable and some- times unpredictable potential for harm.
When adverse effects and toxicity do appear, especially when previously unknown, it is essential that these are
reported, analyzed and their significance is communicated effectively to the audience having knowledge to
interpret the information. For all medicines, there is a trade-off between the benefits and the potential for harm.
The harm can be minimized by ensuring that medicines of good quality, safety and efficacy are used rationally,
and that the expectations and concerns of the patient are taken into account when therapeutic decisions are made.
To achieve this is to serve public health, and to foster a sense of trust among patients in the medicines they use
that would extend the confidence in the health service in general, ensure that risks in drug use are anticipated and
managed, provide regulators with the necessary information to amend the recommendations on the use of the
medicines, improve communication between the health professionals and the public and educate health
professionals to understand the effectiveness or risk of medicines that they prescribe.