NAC Work Plan 2016/2017

Transcription

1 Contingency initiatives led by the NAC Blood Shortages Working Group(BSWG) National Plan for the Management of Shortages of Labile Blood Components Plan for a national mock blood shortage (red phase) which is extreme enough for the NEBMC to recommend using the Emergency Framework Document. Documents posted to NAC Website English and French Review Current Plan dated Version dated Start February 2013 S. Nahirniak Simulation Exercise - November 2013 determine a date for a simulation exercise, then incorporate lessons learned into The Plan BN presented to PT CBS March 2014 BLC March 19, 2014 to request the BSWG to create a job aid (JA). This will provide corrective action to observations/gaps noted in The Plan during the simulation exercise The National Plan Update completed and translated; Fall 2015 Job Aid (JA) Created Update Ongoing updates by the BSWG are in progress Tools- Templates for Patients and Media, Platelet Aliquotting Procedure, etc. Spring Update - -On Target 1

2 Contingency initiatives led by the NAC Blood Shortages Working Group Con t Emergency Framework For Massively Bleeding Patients This document was developed to help guide Physicians to triage patients in need of massive transfusion during a red phase shortage. Original version posted Documents posted to NAC Website English and French Prospective or retrospective audit Review Current Triage Document dated Version dated S. Nahirniak November 2013 Simulation Exercise; data to be compiled from validation exercise Start Fall 2014 Triage Document under revision: Updates include: Outcome of simulation exercise, triage tools, triage clinical decision flow chart etc. Spring 2017 On Target Contingency - initiatives led by the NAC Blood Shortages Working Group Con t Inventory Planning A Briefing Note was presented supporting the concept of a transparent national inventory with unique blood system indicators... A second Briefing Note was presented supporting CBS hospital Liaison Specialist teams efforts to identify hospitals or hospital groups that will report daily inventory when required Reconvene working group Presented / Approved by PT CBS BLC Presented / Approved by PT CBS BLC Draft inventory recommendation (indices for each stage) 2013 June 2013/Aug 2013 March 2015/Feb 2015 S. Nahirniak 2

3 Inventory Planning- There is a recommendation for hospitals to conduct inventory submission exercises on a quarterly basis. A rolling 12 month disposition reporting period will be used to calculate ADRD. These exercises are proposed for December, April, July and October of each year. Spring 2016 On Target O-Negative Red Cell Utilization At the NAC meeting in April 2015, NAC recommended that we work to draft a document on O RH Negative Red Cell Utilization Drafting a document to circulate to members on O Rh Negative Red Cell Utilization. Fall, 2016 KW, KP, DL Safety No current initiatives Benchmarking CMV At the NAC meeting in April 2012, NAC recommended that all provinces and territories work to minimize unnecessary use of CMV seronegative blood components. A CMV Working Group formed. NAC in discussions re: appropriateness of use of CMV sero negative vs CMV safe product (cost/benefit) since 100% of blood components are Leuko- Reduced (LR) in Canada. Vox Sang international forum on CMV 2012 Letter sent to CMAJ inquiring whether a commentary on the state of prevention of cytomegalovirus infection transmission by blood product transfusion would be considered for publication. Pending a response from CMAJ No response 2013 NAC decided a different route S. Nahirniak 3

4 Recommendation Vs. White Paper NAC decided May 2014 to write a statement regarding appropriateness of use of Cytomegalovirus (CMV) sero negative vs CMV safe product Lack of data in some populations 2014 August 2014 posted to NAC s website NAC decided a different route At the October, 2015 meeting, NAC decided to revise the current recommendation and update the White Paper. Fall, 2016 Guidelines Participation in International Collaborative Platelet Guideline document is pending final review for submission. NAC member to provide linkage between Collaborative and NAC November 2013; platelet guideline revisions are to be submitted to BLOOD; Ongoing S. Nahirniak Summer 2014 Published TMR November 2014 Guidance on Platelet Transfusion for Patients with Hypoproliferative Thrombocytopenia 4

5 Guidelines con t RBC - transfusion policy framework NAC endorsed the AABB guidelines. Briefing Note prepared June 25, 2013 to present to the PT CBS BLC for their support in endorsing AABB guidelines as well as the development of a companion document to address gaps identified in the AABB guidelines. PT CBS BLC supported BN on August 05, Reconvene working group December 2012 J. Fesser AGREE analysis of GAIN and AABB recommendations Spring 2013 Present to PT CBS BLC June 2013 PT CBS BLC supports the creation of a Companion Document RBC WG commenced the creation of a companion document - January 2014 August 2013 May/June 2014 Posted May 28, 2014 Guidelines con t Indications for Use of Fibrinogen Concentrate in Acquired Hypofibrinogenemia NAC recognizes that the introduction of this product has a potential for significant uptake and potential use for indications for which it is not currently licensed. Development of optimal use guidelines, pending CADTH review On hold, pending PT s request for development of guidelines. B. Muirhead NAC was on to develop guidelines for use of FC for indications of acquired hypo fibrinogenemia WG convened NAC responded on that it was feasible for NAC to develop Recommendations not Guidelines, Spring

6 The Fibrinogen (WG) agreed on that presently there is very little literature available to make a recommendation. Direction: Prepare a statement for posting on At the fall, 2015 NAC meeting, it was decided to proceed with a cost analysis for fibrinogen concentrate versus cryoprecipitate Statement prepared Dec 15, 2014 Study to proceed Spring, 2017 On Target Taher Rad Guidelines Con t IVIG Neurology Guidelines Guidelines require periodic review DA volunteered to contact Dr. Feasby interested in Tom Feasby about his redoing the neurology guidelines. interest in the IVIG but not interested in leading ; neurology guideline review. would require funding and methodological supports. November discussed options to get reviews completed Next steps discussed, agreed to bring a proposal to April 2014 meeting On Target A. Tinmouth April 2014 Guidelines require periodic review; systematic reviews are arduous and, as NAC are not the primary author for April BN presented to PT CBS BLC March 19, Re: Monies required to be carried forward from 2013/2014 to 2014/2015 for outsourcing 6

7 3 of the IVIG guidelines, these reviews will need to be contracted out systematic reviews Approval to set funds aside Business case outlining preferred option as well as a briefing Note provided to the PT CBS BLC in October. October 2014 PTs NAC to Investigate partnering with CADTH Investigation completed- BN presented to PT CBS BLC March 2014 October 2016 Signal detection process to be completed IVIG Hematology Guidelines IVIG Primary Immune Deficiency Guidelines Guidelines require periodic review Guidelines require periodic review Review according to the process noted for Neurology October 2016 Signal detection process to be completed NAC waiting to hear from November 2013 confirmed with primary author Dr. Shehata Dr. Shehata there are no plans to update guidelines On Target A. Tinmouth NAC Chair Guideline will be assessed once Hematology and Neurology undergo the new review process 2017 On Target IVIG Solid Organ Guidelines Guidelines require periodic review NAC waiting to hear from November 2013 confirmed with primary author Dr. Shehata Dr. Shehata there are no plans to update guidelines On Target NAC Chair Guideline will be assessed once Hematology and Neurology undergo the new review process 2017 On Target 7

8 Recommendation for Use of Prothrombin Complex Concentrates in Canada Review document to support and/or recommend revisions in consideration of available evidence, literature, cost effective utilization management of PCC products and optimization of patient care In Progress Fall 2013 Delayed S. Nahirniak New date -Spring Chair of WG waiting to review Netherland's document for dosing information pertaining to INR 1.7 WG finalized document May 16, 2014 Recombinant Factor VIIa Direct Thrombin Inhibitor Website Statement Appropriate Use of S/D Treated Plasma in Canada Recipient Recall Notification Guidelines require periodic review New Oral anticoagulant use is increasing and there is physician concern about the availability of reversal therapies BN January The approval period for S/D plasma requests has been extended to 12 month Each fiscal the Post Donation and Error/Accident Risk tables must be updated Budget Budget Discussed F to F April NAC determined that currently this guideline is the most up to date published NAC guideline; to be revised November, Next review -November 2016 On Target NAC Chair NAC revised statement on website November 2014 November 2014 NAC Chair Document revised January 2015 NAC Chair Document to be revised June 2015 NAC Chair 8

9 Scientific/Medical Review of Products for CBS Irradiation CBS Therapeutic Drug Product Review In reference to CBS data collected on transfusion of irradiated products, the importance of giving irradiated blood components to only those patients that absolutely require it needs to be stressed. The purpose of this document is to emphasize this point and provide guidance to hospitals. CBS NAC to review Corifact TM Scientific review on CBS NAC to review long acting Factor IX product Alprolix TM CBS NAC to review review Eloctate TM Draft document - Recommendation for the use of Irradiated Blood Components in Canada on hold, waiting for more information from CBS's study. Update: Study provided. NAC to review what the next steps will be at May face to face 2014 meeting. To be determined D. Morrison May 2014 Item carried forward and discussed November Nov 2014 formal request November 2014 from PT CBS BLC to develop recommendations for the use of irradiated products A WG formed Nov to develop recommendations for the use of irradiated blood components Fall Oct-11 J. Fesser 2014-Nov-28 T. Rad 2015-Mar-16 K. Pavenski 9

10 Hema Quebec (HQ) criteria for the Long Acting Category approved by CDM (Sept 2015). NAC to identify the non-pre approved criteria requiring Specialist recommendation as per HQ. NAC also engaged to recommend data elements to monitor. Urgency- December, 2015 On Track B. Muirhead CBS NAC to review OBIZUR CBS NAC to review PANZYGA 2016-June-23 A.Tinmouth/B. Muirhead November, 2016 B. Muirhead Other request from PTs Dosing guidelines for the Factor XIII product - Corifact TM Request received from PTs to NAC on 2013-Oct-18 to develop dosing guidelines for Corifact TM ( Factor FXIII) BN presented to PT CBS BLC Feb 2014 re: Dosing guidelines March 06, 2014 the PT CBS BLC supports NAC s decision in not moving ahead with dosing guidelines at this time. No further action. NAC will revisit request if there is inappropriate use of this product. NAC Chair Other request from PTs The appropriateness of, and a recommendations for, use of the subcutaneous formulation of Ig in indications other than primary Request received from PTs 2013-March- 20 for Investigation of the appropriateness of, and a recommendations for, use of the subcutaneous formulation of Ig in indications other than BN presented to PT CBS BLC May 2014 re: Subcutaneous IG request. June 16, 2014 the PT CBS BLC supports NAC s decision in not moving ahead with this initiative at this time. No further action. NAC will revisit request if there is evidence for use of this product in NAC Chair 10

11 immunodeficiency (PID) primary immunodeficiency (PID) conditions other than PID. Other request from PTs Development of a At the NAC meeting in April, sentinel event system 2015, NAC recommended that a working group be formed for reporting adverse events. Working Group to be convened Spring, 2016 NAC Chair 11