Approve Minutes Motion to approve the last 2 meeting minute, Jose Galvez, Norman Gregory, – Abstain 0, Negative 0, Approve 19. – – – Adam Kroetsch (FDA) REMS (see attached slides) Question & Answers Supporting both approval by administrators and audit Presently, follows communication standard Feedback on whether message approved, received, or not approved (with explanation) Receive annual REMS assessment reports, through routine transactions as well as periodic assessments (surveys, etc) E.g. opioid REMS SPL complementary, not to be used to exchange REMS information between drug companies and healthcare providers A static source of info for dispensers and prescribers to draw upon, providing metadata for REMS platform standards FDA has already addressed implementation of REMS, guidance in progress requiring industry to provide REMS info through SPL ( page) Data model was built by Gunther Will check if interactions and counter-indication information has been compared with IDMP clinical particulars Will consider expanding the Implementation Guide to clarify the purpose of including REMS information, such as listing supporting activities BR&R asked to review the draft guidance and suggest other ongoing HL7 where REMS could leverage existing standard development activities BR&R to have a discussion with Pharmacy WG NCPDP systems are bound by HIPPA, making it more difficult to bring HL7 in May be easier to bring on the clinical research side May utilize FHIR Medication Resource. REMS along may not be a justification to change an existing standard, but could expand on other activities Need to work with Pharmacy to ensure REMS requirements have been met BR&R will conduct a review of needs assessment May go beyond BR&R and Pharmacy, need to explore who else may need to be involved Attachments: FDA REMS Platform Standards Initiative: Needs Assessment –
Approve Minutes – Motion to approve the last 2 meeting minute, Jose Galvez, Norman Gregory, Abstain – 0, Negative – 0, Approve – 19. Adam Kroetsch (FDA) REMS (see attached slides) Question & Answers Supporting both approval by administrators and audit Presently, follows communication standard Feedback on whether message approved, received, or not approved (with explanation) Receive annual REMS assessment reports, through routine transactions as well as periodic assessments (surveys, etc) E.g. opioid REMS SPL complementary, not to be used to exchange REMS information between drug companies and healthcare providers A static source of info for dispensers and prescribers to draw upon, providing metadata for REMS platform standards FDA has already addressed implementation of REMS, guidance in progress requiring industry to provide REMS info through SPL ( page) Data model was built by Gunther Will check if interactions and counter-indication information has been compared with IDMP clinical particulars Will consider expanding the Implementation Guide to clarify the purpose of including REMS information, such as listing supporting activities BR&R asked to review the draft guidance and suggest other ongoing HL7 where REMS could leverage existing standard development activities BR&R to have a discussion with Pharmacy WG NCPDP systems are bound by HIPPA, making it more difficult to bring HL7 in May be easier to bring on the clinical research side May utilize FHIR Medication Resource. REMS along may not be a justification to change an existing standard, but could expand on other activities Need to work with Pharmacy to ensure REMS requirements have been met BR&R will conduct a review of needs assessment May go beyond BR&R and Pharmacy, need to explore who else may need to be involved Attachments: FDA – REMS Platform Standards Initiative: Needs Assessment
2017-10-31%20BRR%20Call%20Minutes.docx