How is Post-marketing Adverse Event Reporting Done for OTC Drugs?

  • By: Staff Editor
  • Date: May 04, 2012
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Non-prescription (OTC) drugs marketed without an approved application are also subject to adverse event reporting requirements, under section 760 of the Federal Food, Drug, and Cosmetic Act. A report of each adverse drug experience which is both serious and unexpected must be made to the Agency, as soon as possible, but no later than 15 days, after receiving information about the event.

FDA’s Guidance on Post-marketing Adverse Event Reporting for OTC Drugs
The guidance emphasizes the following aspects:
  1. the minimum data elements that should be included in a serious adverse event report,
  2. the label that should be included with the report,
  3. reporting formats for paper and electronic submissions,
  4. how and where to submit the reports.
Reporting requirements for OTC (Over-the-Counter or Non-prescription Drugs) drugs without an approved application:
  • The responsible person (manufacturer or distributor) whose name appears on the label of an OTC drug marketed in the United States without an approved application must submit to FDA any report received of a serious adverse event associated with the drug, accompanied by a copy of the label on or within the retail package of the drug.
  • Follow-up reports of newly retrieved medical information (if any) related to a submitted serious adverse event report that is received within 1 year of the initial report and serious adverse event reports received through the address or telephone number described on the product label must be submitted to FDA no later than 15 business days after a report (related to an adverse event or new medical information) is received by the responsible person.
Minimum Data Elements for an Individual Case Safety Report (ICSR)
  • Responsible persons should provide all known or reasonably known applicable elements on FDA Form 3500A or its electronic equivalent, in order to complete an Individual Case Safety Report (ICSR) and submit the same within 15 business days of receipt of the report of serious adverse event. All FDA Form 3500A submissions should be legibly printed or typewritten and legible photo-static copies can also be submitted.
  • The Agency suggests that a reasonable attempt should be made to obtain complete information for case assessment during initial contacts and subsequent follow-up, it also encourages responsible persons to use trained health care practitioners to query reporters, computer- assisted interview technology and targeted questionnaires to help focus the line of questioning for retrieving information for assessment.
  • When the reporter is a patient or consumer, the responsible person should attempt to contact the health care practitioner familiar with the patient’s adverse event, after taking the person’s consent in order to obtain further medical information and to retrieve relevant medical records, if appropriate.
  • The four data elements listed below should be included in any serious adverse event report for an OTC drug product that is marketed without an approved application:
                 (a) an identifiable patient
                 (b) an identifiable reporter
                 (c) a suspect drug
                 (d) a serious adverse event or fatal outcome
  • The responsible person should not submit a report on the event to FDA unless and until, information about each minimum data element is obtained and should maintain records of the event information, including documentation of its efforts to obtain the minimum data elements for a period of 6 years and allow the Federal Agency to access the records.
  • If a report received by the responsible person refers to groups of unknown size, a follow up should be done to find out the number and distinguish each patient, so that it is clear that each ICSR is not a duplicate report of a single adverse event and then a separate report to FDA for each identifiable patient can be submitted.
  • Patients should not be identified by name or address when reporting to FDA, but should be assigned a code to each ICSR.
  • The responsible person should have sufficient information to indicate that there is an identifiable person who purports to have knowledge about the patient, adverse event and drug involved and extra-care should be taken to avoid submission of reports for which the reporter clearly lacks sufficient knowledge. The responsible person should attempt to obtain the reporter’s contact information for follow-up.
  • In order to identify a suspect drug for an adverse event, the responsible person should have information on the active ingredient(s) used by the patient.
  • According to safety reporting requirements, if a serious adverse event involves multiple suspect drug products - manufactured, packaged or distributed by more than one responsible person, then the responsible person should submit only one ICSR with one manufacturer report number, detailed information about manufacturer B’s product(s) and a copy of the label of manufacturer A’s suspect product etc.
  • The responsible person should submit a copy of the full outer container label and immediate container label that are the same as the label on the drug product use.
  • In case of Serious Adverse Events - responsible persons should also provide any available information on the event(s) as a part of the report: Inclusion of supporting documents like hospital discharge summaries, autopsy reports, relevant laboratory data, other critical clinical data etc.
  • In case a responsible person receives a report of an adverse event regarding one of its products from another person, even in such circumstances, he must submit an ICSR to FDA within the same timeframe applicable to any report received from a reporter.
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Submission of New Medical Information (Follow-up Reports)
  • The responsible person must submit a follow-up report when new medical information related to a submitted serious adverse drug event report (including correction of previously submitted inaccurate information) is received by the responsible person within 1 year of the initial report.
  • Relevant information from the initial report should be combined with the follow-up information to present an accurate and comprehensive, but concisely written, description of the event and submitted no later than 15 business days after the new information is received by the responsible person.
  • The responsible person should consider the clinical relevance of the serious adverse events when determining whether an initial report or follow-up report should be submitted.
  • Any unchanged supporting documentation like hospital discharge summaries, lab results etc or labels submitted with an initial report should not be resubmitted with a follow-up report.
  • Any information from the initial report which is later found to be inaccurate or invalid should not be repeated in the follow-up report.

 Additional Resources

Read the FDA guidance in full.

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