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Abstract: Pharmacovigilance is the detection of
drug related problems through recording of patients’
experiences. Effective communication of the
pharmacovigilance objectives to consumers is the key
component to assure recording of timely and true
“signals”. This practice includes not only drugs, but
any health service provided to consumer. Untoward
treatment consequences (health and/or economic) remain
the mainstay of any medical treatment. Consumer need to
be well informed about the products and services so as
to acknowledge their effects (beneficial or harmful) in
the full capacity of an aware consumer. Consumer
including patient(s) should not be hesitant to ask the
health service(s) provider(s) any question(s), they may
have about their medications. The open communication
will decrease the likelihood of a potential undesired
health and/or economic consequences and if any, will be
identified and reported. Moreover, it will hopefully
encourage patient’s adherence with resultant improved
patient care and satisfaction leading to better
therapeutic outcomes. With this background, a trial on
community perusal and community empowerment was carried
out in a selected set of population. The trial shown an
increase in drug related queries and served to enhance
consumer’s expectation towards health care provider. The
enhanced awareness in consumer may serve to prime the
end consumer to be vigilant enough for medicine use and
increase the formal communication between health service
provider and consumer, serving to generate expedited
“signals”.
Introduction
Pharmacovigilance is a science that deals with the
activities relating to the detection, assessment,
understanding and prevention of adverse effects or any
other possible drug-related problems. Specific aims of
pharmacovigilance promote patient care and safety by
promotion of understanding, education, training and its
effective communication to the public. The practice
contributes to assessment of benefit, harm,
effectiveness of drugs and promotes the safe, rational
and cost-effective use of drugs. The practice of
Pharmacovigilance has evolved well to include vigilance
of sale of drugs, self medication practices and
irrational drug donation practices. The issue of
Pharmacovigilance is relevant for every one, who is
involved in any way by medical interventions and include
policy makers, drug regulatory authorities, health care
providers, consumers, health economists, health
epidemiologists, drug information centre personnel,
consumer groups, schools of health sciences and
concerned layperson. For the systematic operations of
science, various National Pharmacovigilance Centres
(NPC) are engaged in promoting the public awareness of
drug safety. Their main scope of activity also include
effective communication of information of rational
medicine consumption to practitioners, patients and
public. Active role players in the practice of
pharmacovigilance are pharmaceutical industries,
hospitals and academia, health professionals, patients,
advocacy groups, lawyers and media.
Among the above role players, patients experience the
actual benefit or harm of a medicine. Observations and
reports of a health professional are an interpretation
of a description originally provided by the patients.
Patients, who suspect that they have been affected by an
ADR are recommended to report to their doctor. But this
process is not sufficient to ensure that the patient’s
concerns are being recorded. Pharmacovigilance serves to
create confidence and trust among patients. This is an
anonymous observation that patient participation in the
reporting of drug related problems will definitely
increase the efficiency of the pharmacovigilance system.
Moreover, there are various studies that indicate that
systems for recording patient concerns might identify
new drug related signals earlier than the professional
reporting systems alone.
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