Adverse Events Reporting Procedure

Chapter eleven: Adverse Event Reporting procedure

Definition: An Adverse Event is defined as a death, life-threatening Adverse drug or device experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent disability/incapacity, or a congenital anomaly/birth defect.

11.1. Liability: As FHCi Patron Members accept the responsibilities and liabilities of working as a Private Member, in a private member-to-member agreement within an FHCiA’s HP Supervisors PMA, under the limitations of the regulations governing PMAs, legal recourse for Adverse Events would be under the jurisdiction of PMA regulations and out of the jurisdiction of public courts or responsibilities of FHCi

However, FHCi stands by the safety, efficacy, and reliability of HPx Programs and Homeopathic Protocols it develops. In addition, operates in transparency for any possible Adverse Event.

Accordingly, in order to serve the public in transparency, if a Patron Member believes they or their children have adversely reacted to an HPx program of Homeopathic protocol in such a way that there may have been an Adverse Event then:

11.2 Procedure:

  1. The Patron Member, or representative, is to contact their FHCiA HP Supervisor as soon as an Adverse Event occurs to seek out the appropriate homeopathic or medical intervention.
  2. The HP Supervisor is to work with the family to evaluate health status of them or their child and emergency medical support if needed.
  3. The HP Supervisor is also to take a full written report of events leading up to an Adverse Event to evaluate if there could be other extraneous circumstance that may have led to Adverse Event, including but not limited to HPx nosode and potency given, gender and age of child, dates of administration, previous reactions to other nosodes, long-term health status of the child, previous vaccinations and reactions to vaccinations, recent illnesses that may be confounding factors, illnesses of other family members or possible contact with other contagious individuals, and/or other environmental, nutritional, or medicinal exposure in the same time frame. HP Supervisor is to complete HP Supervisor Adverse Event Reporting Form within three months of said event.
  4. Supervisor can seek supervision from a program coordinator at any point in the process to assist family in advising for remedial solutions.
  5. After the consultation with the HP Supervisor, the Patron Member is to use the FHCI  Patron Member Adverse Event Reporting form to give a full written description of events that occurred and the medical treatment, homeopathic or otherwise, obtained to mitigate the event. A Patron Member has up to three months after the supposed incidence to submit a written report to FHCi of such an event.
  6. Both Patron Member Adverse Event form and HP Supervisor Adverse Event forms are to be submitted to the FHCi the Adverse Event Review Committee for review. The review committee may contact both Patron and/or HP Supervisor for clarification during the review process.
  7. The Adverse Event Review Committee will review documents and write a full report to be submitted to the Board.
  8. If it is determined that in fact an HPx Program or Homeopathic Protocol did cause an Adverse Event, it will be logged and made public on the website, withholding PHI of the Patron Member or child in question, and the name of the HP Supervisor supervising the case.
  9. Forms below:

All Adverse events will be logged and made public on the website, withholding PHI (Personal Health Information) of the family Member and child in question and the name of the HP Supervisor.  Reported Adverse Events