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Passive Surveillance Method in Pharmacovigilance

The passive surveillance method consists of reporting the diseases, risk- factors or health- related trials. The health professionals spontaneously report about these events as they come to their notice and concern. In this case, the identity of the reporter remains anonymous, but detailed information about the patient such as country, age, gender and co- morbidity can be retrieved from the reporting forms. Pharmacovigilance training, clinical research courses and clinical research training can be very useful to study about these various characteristics in detail.

This method includes:

Spontaneous Reporting :

  • Voluntary communications is carried out by the healthcare professionals or consumers to a company, regulatory authority or other significant organizations for the purpose to make the most of the value of the attached data and further publish the data or study results.
  • A practical Adverse Drug Reaction system (ADRs) is necessary to monitor the safety of all drugs and medicines.
  • Data is composed in a central or regional
  • To discover the safety signals when drugs are
  • The report outline contains the particulars of the patient, the suspected product details and description of the vague reaction.
  • It is the simplest method to start and covers the whole population.
  • This is the most normally used pharmacovigilance method.

Intensified Reporting :

  • It aims to proceed reporting of side effects of specific drugs and medications in first post-marketing
  • This is an expansion to the spontaneous reporting program.
  • This procedure is repeatedly followed for new drugs, biological medicines, and for drugs that require further studies.

Stimulated Reporting:

  • It is mostly used for new products for early- post authorization.
  • This system comprises of online reporting of adverse events.
  • It consist details about Patients, Medications and Drugs, ADRs observed and reporter information.

Targeted Spontaneous Reporting:

  • This system is used to learn more about the ADR pattern of specific drugs in the population.
  • To estimate the occurrence of known side effects for medicine in a community.

Hence, Passive surveillance is a comparatively economical strategy for covering large areas, and it provides the important information needed to inspect the public health.

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