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WHO defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. The role of pharmacovigilance is to determine which adverse events cross the line of a drug’s efficacy and analyzing which side effects are worth the risk to patients compared with how effective they are at treating a disease. The safety profile of a new therapeutic agent is not completely evaluated throughout and even at the end of phase I, phase II and phase III clinical study as a few thousand subjects are subjected to the new therapy, and the number is even lesser in clinical studies of orphan drugs. After thalidomide tragedy it has become an essential part of the pharmaceutical industry. The AEs and SAEs observed during the surveillance are termed as signals.
The physicians can work for pharmacovigilance in two ways;
Role of pharmaceutical physicians:
The physicians who are involved in drugs safety evaluation
while working for sponsor companies or biopharmaceutical companies or CROs are
called Drug Safety Physicians or Drug Safety Advisers or Pharmacovigilance
Scientists. The role of the Drug Safety Physician is to evaluate the safety
information which is crucial even after the completion of clinical research. In
pharmacovigilance, the experts report all Serious Adverse Events which are then
classified on the basis whether the events where related or not related to the
drug. The company is expected to monitor, follow up and evaluate all safety
problems aggressively and adverse events observed during post-marketing
surveillance. Drug Safety Physician looks at all the events and sees if there
is a design or a pattern in the reports. This is called signal detection. Some
situations are likely to be because of the drug while others are equivocal and
some especially individuals with a higher background occurrence such as
myocardial infarctions, obese diabetics are difficult to ascribe to a drug
effect. Here the safety physician has to evaluate all the information, usually
case by case, it is like searching for the needle in the haystack. The
physician with the extensive knowledge, strong medical background, a logical
thinking and capable of coming to reasonable and defensible results dependent
on unfinished data or blinded cases can work efficiently in this field.
In all countries, where pharmacovigilance systems operate
the role of physicians is vital in recording and reporting suspected ADRs
observed in their practice. The advantages of an ADR reporting system include
that it operates for all drugs throughout their lifetime and that it is the
only affordable method of detecting rare ADRs. These ADRs are then sent to
WHO-Uppsala Monitoring Centre (UMC) for analysis and signal detection.
Role of medicine practitioners:
During practice the physician has to perform the role of a
clever detective and evaluate all the data, usually case by case. If any
evidence during practice comes across physicians, it should be monitored
carefully, and the physician must submit Periodic Safety Update Reports (PSURs)
to regulatory authorities by assessing the totality of the safety data. For
such a sharp evaluation the physician must have experience and strong medical
background so that the triage of cases and severity can be identified and
evaluated. To verify proper selection of adverse events from source documents,
to determine appropriate MedDRA code, assess labeling, review narrative. The
Suspected Adverse Drug Reaction Reporting Form can be filled and can be sent to
nearest ADR Monitoring Centre (AMC). The ADRs are sent to WHO-Uppsala
Monitoring Centre (UMC) for analysis and signal detection. The respective
regulatory bodies of different countries such as USFDA, MHRA, CDSCO, EMA take
necessary action againts those drugs.
The participation of physicians is therefore considered
essential for the functioning of the pharmacovigilance system.
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