1. Proposed changes to hemoglobin and donation interval criteria for whole blood donors: Projected impact on current donor base Anne Eder, MD PhD Executive Medical Officer Blood Products Advisory Committee Meeting July 27, 2010

2. 2 Four Questions What would be the impact of changing the minimum predonation Hemoglobin (Hb) from 12.5 g/dL… 1.…to 13.0 g/dL for men? …to 13.5 g/dL for men? 2. …to 12.0 g/dL for women? What would be the impact of changing the interdonation interval from 8 weeks (about 6-7 times per year) ….. 3.….to 12 weeks (about 4-5 times per year) for men? 4.….to 16 weeks (about 3-4 times per year) for women?

3. 3 Balance Sheet Minimum Hemoglobin CurrentProposed Difference in Donations Men 12.5 13.0 13.5 Women12.0 Donation Interval (Frequency) Men ~ 6 -7 ~4-5 (4.33) Women ~3-4 (3.25)

4. 4 Puerto Rico Annual Data – (Denominator) 6 M Red Cells 1.7 M Plasma Products 850,000 Apheresis Platelets 250,000 WB-derived Platelets 40,000 Pooled Platelets American Red Cross, 2010

5. 5 Hb Distribution, Presenting Donors Male Female NHLBI Retrovirus Epidemiology Donor Study-II (REDS-II) New England Region, ARC, 2008-2009

6. 6 Question 1: Minimum Hb for Men Number of Male Presentations ARC - CY2008 Projected additional deferral* Change in Donations 3,883,3453.78% - 146,790 Hb 12.5 → 13.0 g/dL for men Hb 12.5 → 13.5 g/dL for men 3,883,3459.96%- 386,781 *NHLBI Retrovirus Epidemiology Donor Study-II (REDS-II) New England Region, ARC, 2008-2009

7. 7 Question 2: Minimum Hb for Women Total Female Presentations ARC - CY2008 Projected gain* Change in Donations 3,987,923 4.97% (Reduce Hb deferral by 40%) + 198,200 Hb 12.5 → 12.0 g/dL for women *NHLBI Retrovirus Epidemiology Donor Study-II (REDS-II) New England Region, ARC, 2008-2009

8. 8 Questions 1&2: Minimum Hb Male Donors CurrentProposed Difference in Donations Hb(g/dL)12.5 13.0 - 146,790 13.5 - 386,781 Female Donors CurrentProposed Difference in Donations Hb(g/dL)12.512.0 + 198,200

9. 9 Questions 3 & 4: Frequency Number of Annual Donations Percentage of DonorsTotal Donations MenWomenMenWomen 148.1%50.6%777,352933,091 223.3%25.4%751,658937,594 312.9%13.1%624,093726,936 47.6%6.5%490,240389,233 54.7%3.0%330,157179,195 62.7%1.1%186,45969,014 70.8%0.2%56,66314,547 American Red Cross, Cohort of CY2008 whole blood donors followed for 365 days (6,466,231 donations)

10. 10 Questions 3 & 4: Frequency Number of Annual Donations Percentage of Donors MenWomen 148.1%50.6% 223.3%25.4% 312.9%13.1% 47.6%10.8% donors 261,494 (7.4%) donations* 58.2% donors 157,378 (4.7%) donations* 6 7 *Based on fractional estimates for frequency: 4.33 for men; 3.25 for women American Red Cross, Cohort of CY2008 whole blood donors followed for 365 days (6,466,231 donations)

11. 11 Balance Sheet Minimum Hemoglobin CurrentProposed Difference in Donations Percent Gain or Loss Men 12.5 13.0- 146,790 - 4% 13.5- 386,781- 10% Women12.0 +198,200 + 5% Donation Interval (Frequency) Men ~ 6 -7 ~4-5 (4.33) - 157,378- 5% Women ~ 3-4 (3.25) - 261,494- 7%

12. 12 Conclusions In the ARC system, changing the minimum hemoglobin requirement to13.0 g/dL for men and 12.0 g/dL for women is predicted to have little effect on total collections Changing the donation interval is predicted to have a significant, detrimental effect on collections

13. 13

14. 14 Donation Frequency – Cohort Day 1 Donation 1 Day 57 Donation 2 Day 113Donation 3 Day 169 Donation 4 Day 225 Donation 5 Day 281 Donation 6 Day 337 Donation 7 And 28 days left until New Years.

15. 15 Model Donation Interval 56 d0 = 6 donations 56 d Original Interval New Interval 112 d0 = 3 donations 112 d

16. 16 Donation Interval – Male Donors Current (56 days) New (84 days) Donors1,616,067 Total Donations3,373,9992,844,305 Return Donations1,757,9321,228,238 # Donations-529,694 % Donations-15.7%

17. 17 Donation Interval – Female Donors Current (56 days) New (112 days) Donors1,844,812 Total Donations 3,511,104 2,903,147 Return Donations 1,666,2921,058,335 # Donations -607,957 % Donations -17.3%