OpenBiome SAFE Protocol Overview Quality & Safety Program SAFE Protocol Overview Fecal microbiota preparations (FMP) are an Investigational New Drug subject to the FDA’s adverse event protocols. As a nonprofit dedicated to providing safe access to FMT, in addition to these federally mandated reporting policies, we have implemented additional safeguards described below in our SAFE protocol. To ensure a uniform standard of reporting, adherence to our SAFE protocol is mandatory for continued use of OpenBiome FMPs. This policy allows us to enable safe, accountable, high-quality care for FMT patients. SAFE Protocol Definitions Serious Adverse Event In alignment with the FDA, a serious adverse event is defined as any of the following outcomes: Death: Report if death was a suspected outcome of the adverse event, and include the date. Life-threatening: Report if suspected that a patient was at substantial risk of dying at time of the adverse event, or ongoing use of FMP might have resulted in the death of the patient (e.g., repeat FMT). Hospitalization (initial or prolonged): Report if admission to the hospital or prolonged hospitalization was a result of the adverse event. Emergency room visits that do not result in admission to the hospital should be evaluated for one of the other serious outcomes (e.g., life-threatening, etc.). Disability or Permanent Damage: Report if the adverse event resulted in a substantial disruption of a person's ability to conduct normal life functions, i.e., the adverse event resulted in a significant, persistent or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities and/or quality of life. Congenital Anomaly/Birth Defect: Report if you suspect that exposure prior to conception or during pregnancy may have resulted in an adverse outcome in the child. 196 Boston Avenue Suite 1000 Medford, MA 02155 Phone: 617 575 2201 Fax: 617 575 2201 E-Mail: [email protected] Web: www.openbiome.org Rev Oct 2014 Serious Adverse Event (continued) Other Serious (Important Medical Events): Report when the event does not fit the other outcomes, but the event may jeopardize the patient and may require medical/ surgical intervention to prevent one of the other outcomes. Examples include allergic brochospasm (a serious problem with breathing) requiring treatment in an emergency room, serious autoimmune disease (Sjogren’s syndrome, rheumatoid arthritis) or seizures/convulsions that do not result in hospitalization. FMT Non-Response Keeping with clinical guidelines, treatment response exists when either stool frequency decreases or stool consistency improves and parameters of disease severity (clinical, laboratory, radiological) improve with no new signs of severe disease. In all other cases, treatment is considered a FMT non-response, being either: Recurrence: CDI re-occurs within 8 weeks after the onset of a previous CDI episode, provided the symptoms from the previous episode resolved after completion of treatment Refractory: Ongoing or worsening CDI symptoms despite treatment Given the high response rates reported in the literature and experienced by our partners, non-responses are unexpected events that require careful evaluation to detect patterns that might enable future improved care. All non-responses must be reported to OpenBiome using the FMT Non-Response Reporting Form. Evaluation of Inventory Inventory evaluation allows OpenBiome to understand the usage and status of treatments across our clinical network and will aid in coordinating a potential network-wide response to potential SAEs. Hospitals should track the Unit ID used in an administration within the patient’s records (Note: No patient information should be shared with OpenBiome, nor will OpenBiome ever request patient information). Each new order must be accompanied by a Material Tracking Log for previously delivered FMPs. Contact Information General Questions | Contact OpenBiome by email at [email protected] or call 617-575-2201 OpenBiome Submissions | Email forms to [email protected] or fax forms to 617-575-2201 Form 3500, Non-Response Reporting Forms, Tracking Logs FDA Submissions FDA MedWatch Form 3500 | Fax forms to 800-FDA-0178 or mail forms to The FDA Safety Information and Adverse Event Reporting Program, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852-9787.