Spontaneous Adverse Event Reporting

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The spontaneous adverse event reports are collected from patients, health care providers, lawyers, health authorities, the medical literature, and other sources. The spontaneous reporting systems provide the highest volume of information at the lowest maintenance cost and have proven their value in the early detection of patient safety issues related either to the products themselves or to their use.
In spontaneous reporting, the most common form of PV, no measures are taken to systematically follow-up patients to record ADRs that they may have experienced. Reporting is dependent on the initiative and motivation of the reporters. This leads to underreporting compared with actual incidence of ADRs [1]. The absence of an effective PV system with
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Public health programs may treat a large population in an organized and structured fashion and record the number of patients treated, drugs used, doses given etc.
It is important to know what ADRs may be expected with certain treatment and how many will experience this ADR. Such quantitative information will have a direct impact on treatment guidelines, policies and practices. In addition, we need to monitor adverse events attributed more to aspects such as inappropriate use, medication errors, poor quality products or drug-drug interactions. Following are the solutions for overwhelming obstacles in spontaneous reporting.

1) To facilitate easy contact with and quick access to a hospital pharmacovigilance system:
• Use of technology (phones, fax, worldwide web, e-mail . . .)
• Use of reminders or advertisements
• Availability of yellow cards or forms for reporting
• Direct
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