1. A Method to Estimate the Burden of Foodborne Illness Angela Lasher CFSAN-FDA Angela.Lasher@fda.hhs.gov

2. Total Burden of Foodborne Illness Health Loss QALDs-QWB and EQ-5D VSL Doctor and hospital costs Visits Medication Lost productivity Work costs Social costs

3. Calculating QALDS Lost- The Quality of Well Being (QWB) Scale QWB= 1 + Symptoms + Mobility + Physical + Social (Kaplan, et al 1993) Symptom = -0.29 Sick or upset stomach, vomiting, or loose bowel movements, with or w/o fever, chills, or aching all over Mobility = -0.062 Did not drive car or use public transportation for health reasons; -0.09 In hospital as bed patient overnight Physical Activity = -0.077 In bed, chair, or couch for most or all of day… Social Activity = -0.061 Limited or did not perform major or other role activities for health reasons, but performed self-care; -0.106 Did not perform self-care activities or had more help than usual for age

4. Calculating QALDS Lost- The Kaplan QWB Scale cont. QWB= 1 + Symptoms + Mobility + Physical + Social Severity of IllnessSymptomMobilityPhysicalSocial Well- being QALDs Lost non- hospitalized-0.29-0.062-0.077-0.0610.510.49 Hospitalized-0.29-0.09-0.077-0.1060.440.56

5. Calculating QALDS Lost- The EQ-5D Scale EQ-5D Health Status Classification System Domain Attribute LevelDescription Mobility 1I have no problems walking about 2I have some problems walking about 3I am confined to bed Self-Care 1I have no problems with self-care 2I have some problems washing or dressing myself 3I am unable to wash or dress myself Usual Activities 1I have no problems performing my usual activities 2I have some problems performing my usual activities 3I am unable to perform my usual activities Pain/Discomfort 1I have no pain or discomfort 2I have moderate pain or discomfort 3I have extreme pain or discomfort Anxiety/Depression 1I am not anxious or depressed 2I am moderately anxious or depressed 3I am extremely anxious or depressed

6. Calculating QALDS Lost- The EQ-5D Scale Cont. For non-hospitalized illness = 22221 = 0.689; health lost = 0.311 For hospitalized illness = 22321 = 0.508; health lost = 0.492 Source: Shaw, et. al 2005 (adapts EuroQol Group estimates (GB) for U.S. population)

7. Comparing QWB and EQ-5D Severity of IllnessWell-beingQALDs Lost Per Day QWB non-hospitalized0.510.49 Hospitalized0.440.56 EQ-5D non-hospitalized0.6890.311 Hospitalized0.5080.492

8. Values for QALDS and VSL VSL = $5M and $7M (Viscusi and Aldy 2003) Starting QALD Value = 1, Avg. for Pop. = 0.84 (IOM report 2006) QALD value QALY value (Q=V/Y) QALD value (Q/365) $100,000$274 $300,000$822 $500,000$1,370

9. Physical and Other Costs Doctor Visit = ($0, $78) (Finger 2001) Hospitalization Costs – HCUPnet Data- Healthcare Cost and Utilization Project- AHRQ- Data 2004 Lost work and social time – incorporated into QALD loss

10. Illnesses Quantified Bacillus cereus Botulism, Foodborne Brucella spp. Campylobacter spp. Clostridium perfringens E. coli (O157:H7/shiga-toxin and enterotoxigenic, other) Listeria monocytogenes Salmonella (typhoidal and non-typhoidal) Shigella spp. Staphylococcus Streptococcus Vibro (cholerae, vulnificus, other) Yersinia enterocolitica Cryptosporidium parvum Cyclospora cayetanensis Giardia lamblia Toxoplasmosis gondii Trichinella spiralis Norovirus Rotavirus Astrovirus Hepatitis A Nitrates Ammonia Pesticides Marine toxins

11. Lost QALDs due to Campylobacteriosis Days illQALDs Lost per Day Non- hospitalizedrisk uniform(2,10)0.49 Hospitalizedrisk uniform(5,10)0.56 Health Loss from a Typical Case of Campylobacteriosis Case Break QALDs Lost/CaseLowMediumHigh Non- hospitalized99.46%AA*$274A*$822A*$1370 Hospitalized0.54%BB*$274B*$822B*$1370 Weighted QALDs per case99.46%*A*$274 + 0.54%*B*$274

12. Total Loss of a Typical Case of Campylobacteriosis Severity of Illness Case Breakdown Medical Costs per CaseLowMediumHigh Non- hospitalized99.46% C = risk uniform(0,78)C~ = C + Health Loss costs Hospitalized0.54% D = HCUP data 2004 ($11,275)D~ = D + Health Loss costs Death0.01% weighted cost per case ($5M death) C~*99.46% + D~*0.54% + $5M*0.01% weighted cost per case ($7M death)

13. Secondary Complications of Campylobacteriosis Health Loss SymptomMobilityPhysicalSocialWellbeingQALDs Lost Guillain- Barre-0.333-0.09-0.077-0.1060.390.61 GBS perm disability-0.299-0.062-0.06-0.0610.520.48 ReA-0.1440.000-0.060.0000.800.20

14. Total Loss from Secondary Complications of Campylobacteriosis % acute w/2 nd comp medical costs Dis- utilitydays w/cond total QALDs lostLowMedHigh GBS H = RU(1/1000, 2/1000) HCUP data 20040.61RU(90,365)E E` = E*$822 + medical costs GBS perm dis I = H*RU(7%, 20%) HCUP data 20040.48 4930 (discounted)FF` ReA J = RU(1%, 4%) HCUP data 20040.20RU(25,1825)GG` GBS related deathK = H*RU(2%, 8%) Wgted 2ndary QALDs per case0.18%*E + 0.02%*F + 4%*G weighted 2ndary costs per case $5M death weighted 2ndary costs per case $7M deathE`*H+ F`*I + G`*J + K*$7M

15. weighted acute + secondary QALDs lost Mean = 7.53 Min, Max = (1.8, 16.9) LowMediumHigh Mean (Min, Max) Mean (Min, Max) Mean (Min, Max) weighted Acute ($5M death) + weighted Secondary $3322 ($1370, $6368) $7450 ($2443, $15575) $11578 ($3441, $24782) weighted Acute ($7M death) + weighted Secondary $3573 ($1546, $6711) $7701 ($2619, $15918) $11829 ($3626, $25125)

16. Examples of Catalog Usage Illness Burden of an Outbreak: Salmonella Outbreak In July of 2004, the Pennsylvania DOH investigated a Salmonella Javiana outbreak. Illnesses had been reported in 11 counties throughout Pennsylvania. The investigators linked the reported outbreak to Roma tomatoes sold in sandwiches, wraps, and salads. About 330 Pennsylvanians who ate the sandwiches experienced salmonellosis, and the outbreak was believed to have sickened another 80 people in nearby states. 410 people x 7.8 QALDs lost = 3,198 QALDs lost 410 people x $9193 = $3.8 million (med. $5M)

17. Examples of Catalog Usage cont. FDA proposed a change in 2001 Food Code to reduce the required temperature for cold holding of food in retail and foodservice establishments. FDA proposed to eliminate cold holding food at any refrigerated temperature higher than 41°F. Some retail and foodservice establishments already cold held foods at 41°F, while others held foods at 45°F or higher. The FDA Listeria Risk Assessment showed that cases of listeriosis could be reduced if baseline cold holding temperatures were universally reduced to 45°F; additional reductions in cases of listeriosis occurred if cold holding temperatures were uniformly reduced from 45°F to 41°F (regardless of time food was kept). Reduction in listeriosis 32.27 QALDs saved per illness avoided $1.1 million saved per illness avoided (med. $5M)