Adverse Events 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.

Since 2009 when the HP Program has been offered under the supervision of HP supervisors under the umbrella of FHCi there has not been an adverse event reported in relation to the use of the nosodes that are supplied for the program. To the extent that we wish to operate under the highest standards we have provided an avenue for recourse if an Adverse Event is believed to have happened.

Procedure for family to pursue if they believe their child has reacted to an HP nosode in such a way that there may be an adverse event:

  • Family Member is to contact their HP Supervisor as soon as event occurs
  • HP Supervisor is to work with family to evaluate health status of the child and to seek out apporopriate emergency medical support if needed
  • HP Supervisor is to take a full written report of events leading up to adverse event to evaluate if there could be other extraneous circumstance that may have led to adverse event, including but not limited to 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 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 Adverse-Event-Reporting-Form for HP Supervisors2017
  • HP Supervisor can seek supervision from within FHCi at any point in the process to assist family in advising for remedial solutions
  • After the consultation with the HP supervisor, Family Member is to use the Adverse Event Reporting Form for Family Member2017 to give a full written description of events that occurred and the medical treatment, homeopathic or otherwise, obtained to mediate the event.
  • This form is to be submitted to the HP Supervisor for review within three months of said event.
  • At that time, HP Supervisor is to submit both forms to the Adverse Event Review Committee for review. The review committee may contact the family or HP Supervisor for clarification.
  • The Adverse Event Review Committee will review documents and write a full report to be submitted to the Board.
  • 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