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CBER 1 Current standards, donor safety and blood supply Orieji Illoh, MD Office of Blood Research and Review Center for Biologics Evaluation and Research.

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Presentation on theme: "CBER 1 Current standards, donor safety and blood supply Orieji Illoh, MD Office of Blood Research and Review Center for Biologics Evaluation and Research."— Presentation transcript:

1 CBER 1 Current standards, donor safety and blood supply Orieji Illoh, MD Office of Blood Research and Review Center for Biologics Evaluation and Research Food and Drug Administration Workshop: Hemoglobin standards and maintaining adequate iron stores in blood donors November 9, 2011

2 CBER 2 Outline l Introduction. l Iron stores in blood donors. ♦Iron depletion and deficiency in blood donors. ♦Interdonation interval. ♦Previous public discussions. l Workshop objectives.

3 CBER 3 Introduction Consideration of the balance between donor safety and blood supply. Donor safety issues. l Iron loss following frequent blood donation. Blood supply issues. l Impact of any changes interdonation interval on blood supply.

4 CBER 4 Why address iron loss in blood donors? Improve donor safety. lAllow adequate time for iron recovery. lDecrease the incidence of iron deficiency among blood donors.

5 CBER 5 Iron depletion and deficiency l Iron loss occurs following blood donation. l Frequent donations may lead to iron deficiency with or without anemia. l Hemoglobin testing is not an accurate measure of iron stores. l Need to consider strategies to mitigate iron deficiency in blood donors.

6 CBER 6 Effects of iron deficiency lAdverse effects include anemia, fatigue, restless leg syndrome, possible cognitive impairment, depression, and anxiety. lThere are reports suggesting a beneficial effect of low iron stores in males undergoing repeated phlebotomy. ♦Favorable lipoprotein profile compared to non blood donors ♦Lower risk of cardiovascular disease ♦Possible reduction of iron-induced oxidative stress van Jaarsveld et al. Atherosclerosis. 2002 Apr;161(2):395-402. Salonen et al. Am. J. Epidemiol. 148 (1998):445–451.

7 CBER 7 Mitigation of Iron loss in blood donors l Allow more time for recovery of iron stores. ♦Interdonation interval l Test for iron stores. ♦e.g. ferritin testing l Iron replacement ♦Provide iron supplements

8 CBER 8 Interdonation interval lAn appropriate interdonation interval should ensure donor safety by allowing time for adequate red blood cell recovery. l21CFR 640.3(b) ♦A person may not serve as a source of Whole Blood more than once every 8 weeks ~ 6 donations/year

9 CBER 9 Increasing the interdonation interval lMay decrease the risk of iron deficiency. lMay allow more time for iron recovery. lMay decrease future donor deferral for low hemoglobin. lWill adversely affect the blood supply.

10 CBER 10 Effect on blood availability Increasing the interdonation interval may negatively affect the supply of the following: lRed blood cells especially O negative RBCs and other rare phenotypes. lCollections obtained by apheresis. ♦Double red blood cells ♦Other blood components lAvailability of donors for reagent manufacturers.

11 CBER 11 International standards lSingle hemoglobin standard: 12.5g/dL Country Hb-male g/dL Hb-female g/dL Donation frequency United States12.5 56 days Canada12.5 56 days Switzerland12.5 Women, 3x/yr, Men 4x/yr

12 CBER 12 International standards l Gender specific hemoglobin standard : Males 13.0g/dL, Females 12.0g/dL Country Hb-male (g/dL) Hb-female (g/dL) Donation frequency France13.012.0 56 days; women 4x/yr, men 6x/yr Australia13.012.0 84 days Israel13.012.0 90 days; 4x/yr

13 CBER 13 International standards l Gender specific hemoglobin standard : Males 13.5g/dL, Females 12.5g/dL Country Hb-male g/dL Hb-female g/dL Donation frequency Europe: Council of Europe 13.512.5 56 days; women 4x/year, men 6x/yr United Kingdom13.512.5 84 days acceptable, but recommend 112 days Scotland13.512.5 84 days (3x/yr) Germany13.512.5 56 days; women 4x/yr, men 6x/yr Sweden13.512.5 84 days; women 3x/yr, men 4x/yr

14 CBER 14 International hemoglobin standards l Gender specific hemoglobin standard : Males 13.0g/dL, Females 12.5g/dL or 11.5g/dL Country Hb-male g/dL Hb-female g/dL Donation frequency Brazil13.012.5 Women 90 days, 3x/yr, Men 60 days, 4x/yr Hong Kong13.011.5 Women 3x/yr, men 4x/yr

15 CBER 15 Previous public discussions

16 CBER 16 Public workshop Workshop: “Maintaining Iron Balance in Women Blood Donors of Child Bearing Age.” June 8, 2001 lDiscussed Iron deficiency in female premenopausal blood donors. ♦Medical issues related to iron replacement ♦Iron replacement and possible protocols lRecommended implementation of a research program on iron replacement.

17 CBER 17 FDA Proposed Rule (November 2007) FDA asked for comments and supporting data on: lIncreasing the interdonation interval. lChanging the hemoglobin or hematocrit levels to 12.0g/dL or 36%, as acceptable minimal values for female allogeneic donors. lThe possibility of adverse effects if a minimum of 12.0g/dL or hematocrit of 36% is used for females. lThe possibility of adverse effects if a minimum of 12.5g/dL or hematocrit of 38% is maintained for males.

18 CBER 18 Representative comments to the Proposed rule lWait for results of REDS II study on iron status in blood donors. lAgree with proposal to lower hemoglobin standard in women to 12.0g/dL. ♦Hemoglobin down to 12.0 g/dL is normal for females ♦Enormous potential to improve the blood supply lDisagree with proposal to lower hemoglobin standard in women to 12.0 g/dL. ♦Does not have any positive benefit to the donor ♦May make women susceptible to iron deficiency or anemia

19 CBER 19 BPAC: September, 2008 Topic: Iron Status in Blood Donors lCommittee members agreed that iron depletion in blood donors is a concern. lDiscussed testing for iron status in the donor setting. lDiscussed alternative strategies to mitigate iron depletion. ♦Iron supplementation, dietary recommendations ♦Changing Hb/hct acceptance standards ♦Modification of interdonation interval

20 CBER 20 Advisory Committee for Blood Safety and Availability: December, 2008 l Include in consent forms: ♦The effects of repeat donation on the donor population. ♦The gender specific effects of iron deficiency on donors. ♦The effects of collecting blood from anemic men using current donation thresholds.

21 CBER 21 BPAC meeting, July 27, 2010 Committee recommendations l Await final analysis of study on blood donors before considering any changes to the interdonation interval. Committee votes l 10-0 to increase hemoglobin requirement for male donors. l 9-0 (one abstention) against a decrease in hemoglobin requirement for female donors.

22 CBER 22 Key points lDonor safety issues ♦Iron deficiency due to frequent donations. lBlood availability issues ♦Impact on blood supply if interdonation interval is changed.

23 CBER 23 Workshop objectives- today l Discuss recent studies on iron status of blood donors. l Discuss strategies to maintain iron balance in blood donors. ♦Review testing methods available for iron stores. ♦Review recent studies on iron supplementation in blood donors. ♦Discuss how changing the interdonation interval could affect blood availability.

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