10.10: Adverse Events Reporting System: All potential adverse events will be assessed and reviewed for reportable Adverse Events. A tally of Adverse Event Reports and Reviews will be made public. After the review process if it is determined that in fact an Adverse Event has happened, non-PHI and details regarding the Adverse Event will be made public.
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.
10.11: Adverse Event Liability: FHCi Patron Research Registrants accept the responsibilities and liabilities of their relationship within their HPx Practitioner’s Private practice which is outside of the jurisdiction 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 believes they or their children have adversely reacted to an HPx program or Homeopathic protocol in such a way that there may have been an Adverse Event then:
- The Patron, or representative, is to contact their HPx Practitioner as soon as an Adverse Event occurs to seek out the appropriate homeopathic or medical intervention.
- The HPx Practitioner is to work with the family to evaluate health status of them or their child and offer medical support if needed.
- The HPx Practitioner 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 participant, dates of administration, previous responses to other nosodes, long-term health status of the person, 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. HPx Practitioner is to complete HP Supervisor Adverse Event Reporting Form within three months of said event and submit to the Review committee.
- HPx Practitioners can seek supervision from program coordinators at any point in the process to assist the family in advising for remedial solutions.
- After the consultation with the HPx Practitioner, the Patron is to use the FHCI Patron 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 up to three months after the supposed incidence to submit a written report to FHCi of such an event.
- Both Patron Adverse Event form and HPx Practitioner 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 HPx Practitioner for clarification during the review process.
- The Adverse Event Review Committee will review documents and write a full report to be submitted to the Board within one month of receipt of both documents.
- 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 and the name of the HPx Practitioner supervising the case.
- 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