The information from ADR cases when first received is generally incomplete. Ideally, comprehensive information would be available on all cases, but in practice efforts should be made to seek additional information on selected reports. In any scheme to optimize the value of follow-up, the first consideration should be prioritization of case reports by importance.
The priority for follow-up should be as follows: cases which are 1) both serious and unexpected, 2) serious and expected, and 3) non-serious and unexpected. In addition to seriousness and expectedness as criteria, cases "of special interest" also deserve extra attention as a high priority (e.g., ADRs under active surveillance at the request of the regulators), as well as any cases that might lead to a labeling change decision.
Follow-up information should be obtained, via a telephone call and/or site visit and/or via a written request. Efforts should be tailored toward optimising the chances to obtain the new information. Written confirmation of details given verbally should be obtained whenever possible. In exceptional circumstances, a regulatory authority might be able to assist an MAH to obtain follow-up data if requests for information have been refused by the reporter. The company should provide specific questions it would like to have answered.
In order to facilitate the capture of clinically relevant and complete information, use of a targeted questionnaire is encouraged, preferably at the time of the initial report. Ideally, healthcare professionals with thorough pharmacovigilance training and therapeutic expertise should be involved in the collection and the direct follow up of reported cases (particularly those of medical significance). For serious ADRs, it is important to continue follow-up and report new information until the outcome has been established or the condition is stabilized. How long to follow-up such cases will require judgment.MAHs should collaborate on follow-up if more than one MAH's drug is suspected as a causal agent in a case.
It is important that, at the time of the original report, sufficient details about the patient and reporter be collected and retained to enable future investigations, within the constraints imposed by local data privacy legislation.
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