LI QUI D LAUNDRY DETERGENT PACKET EXPOSURES REPORTED TO THE NATI - - PowerPoint PPT Presentation

LI QUI D LAUNDRY DETERGENT PACKET EXPOSURES REPORTED TO THE NATI ONAL POI SON DATA SYSTEM ( NPDS)

Surveillance and Evaluation of ASTM Standards

July 16, 2019 Kate M. Reynolds, MPH

Objectives

1) Describe exposures to liquid laundry detergent packets reported to the NPDS during the post period 2) Compare exposures to liquid laundry detergent packets reported to the NPDS during the baseline and post period

Period Definitions

Baseline 01 July 2012 to 30 June 2013 Transition 30 July 2013 to 31 December 2016 Post 01 January 2017 to

• ngoing

3

Previous Presentations of Data

• Baseline period summary

November 2017

• Transition period summary

March 2018

• Post period (2017) summary
• Baseline vs. post period (2017) comparison

June 2018

Previous Presentations of Data

• Baseline period summary

November 2017

• Transition period summary

March 2018

• Post period (2017) summary
• Baseline vs. post period (2017) comparison

June 2018

• Post period (2018; 2017‐2018) summary
• Baseline vs. post period (2018; 2017‐2018)

comparison July 2019

NPDS DATA SUMMARY

• Age: <6 years
• Reason for Exposure: Unintentional general (reason

code used for accidental exposure)

• Date Range: 01 July 2012 to 31 December 2018

(NEW data: 01 January 2018 to 31 December 2018)

• Substance: Exposure to ≥1 liquid laundry detergent

packet with or without other products/substances

NPDS Definitions

All Exposures HCF Evaluation HCF Admission Severe Medical Outcomes All exposures regardless of

• utcome or level of

healthcare facility care Treated/evaluated and release or admitted to a non‐ critical or critical care healthcare facility Admitted to a non‐ critical or critical care healthcare facility Medical outcome

• f major effect

(life‐threatening) or death

7

Exposures by Severity

8

Baseline Period (July 2012 - June 2013) 2017 Period 2018 Period Post Period 2017-2018 All Exposures 10,229 10,821 HCF Evaluations 4,241 (41.5%) 3,570 (33.1%) HCF Admissions 458 (4.5%) 209 (1.9%) Severe Medical Outcomes 64 (0.6%) 19 (0.2%)

Exposures by Severity

9

Baseline Period (July 2012- June 2013) 2017 Period 2018 Period Post Period 2017-2018 All Exposures 10,229 10,821 9,376 20,197 HCF Evaluations 4,241 (41.5%) 3,570 (33.1%) 3,250 (34.6%) 6,829 (33.8%) HCF Admissions 458 (4.5%) 209 (1.9%) 178 (1.9%) 391 (1.9%) Severe Medical Outcomes 64 (0.6%) 19 (0.2%) 8 (<0.1%) 26 (0.1%)

DEMOGRAPHI CS

Baseline Period (July 2012- June 2013) (n=10,229) 2017 Period (n=10,821) 2018 Period (n=9,376) Post Period 2017-2018 (n=20,197) Age Mean (SD), years 2.1 (1.00) 2.3 (1.03) Median, years 2.0 2.0 Age (categorical) <2 years 4,227 (41.3%) 3,468 (32.0%) 2 to <4 years 4,930 (48.2%) 5,886 (54.4%) 4 to <6 years 1,047 (10.2%) 1,444 (13.3%) ≤5 years 25 (0.2%) 23 (0.2%) Gender Female 4,899 (47.9%) 4,999 (46.2%) Male 5,307 (51.9%) 5,796 (53.6%) Unknown 23 (0.2%) 26 (0.2%)

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DEMOGRAPHI CS

Baseline Period (July 2012- June 2013) (n=10,229) 2017 Period (n=10,821) 2018 Period (n=9,376) Post Period 2017-2018 (n=20,197) Age Mean (SD), years 2.1 (1.00) 2.3 (1.03) 2.3 (1.04) 2.3 (1.04) Median, years 2.0 2.0 2.0 2.0 Age (categorical) <2 years 4,227 (41.3%) 3,468 (32.0%) 2,990 (31.9%) 6,458 (32.0%) 2 to <4 years 4,930 (48.2%) 5,886 (54.4%) 5,099 (54.4%) 10,985 (54.4%) 4 to <6 years 1,047 (10.2%) 1,444 (13.3%) 1,268 (13.5%) 2,712 (13.4%) ≤5 years 25 (0.2%) 23 (0.2%) 19 (0.2%) 42 (0.2%) Gender Female 4,899 (47.9%) 4,999 (46.2%) 4,356 (46.5%) 9,355 (46.3%) Male 5,307 (51.9%) 5,796 (53.6%) 5,002 (53.3%) 10,798 (53.5%) Unknown 23 (0.2%) 26 (0.2%) 18 (0.2%) 44 (0.2%)

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COMPARI SON OF AGE

Baseline Period (July 2012 - June 2013) (n=10,229) Post Period 2018 (n=9,376) p-value Age Mean (SD), years 2.1 (1.00) 2.3 (1.04) <0.001 Median, years 2.0 2.0 IQR, years (1.4, 3.0) (1.6, 3.0) Age (categorical) <2 years 4,227 (41.3%) 2,990 (31.9%) <0.001 2 to <4 years 4,930 (48.2%) 5,099 (54.4%) 4 to <6 years 1,047 (10.2%) 1,268 (13.5%) ≤5 years 25 (0.2%) 19 (0.2%)

12

COMPARI SON OF AGE

Baseline Period (July 2012 – June 2013) (n=10,229) Post Period 2017-2018 (n=20,197) p-value Age Mean (SD), years 2.1 (1.00) 2.3 (1.04) <0.001 Median, years 2.0 2.0 IQR, years (1.4, 3.0) (1.6, 3.0) Age (categorical) <2 years 4,227 (41.3%) 6,458 (32.0%) <0.001 2 to <4 years 4,930 (48.2%) 10,985 (54.4%) 4 to <6 years 1,047 (10.2%) 2,712 (13.4%) ≤5 years 25 (0.2%) 42 (0.2%)

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DEMOGRAPHI CS

2017

All Exposures (n=10,821) Exposures Involving HCF Evaluation (n=3,579) Exposures Involving HCF Admission (n=213) Exposures with Severe Medical Outcomes (n=18) Age Mean (SD), years 2.3 (1.03) 2.3 (1.05) 1.9 (1.12) 2.2 (1.33) Median, years 2.0 2.0 1.8 2.0 Age (categorical) <2 years 3,468 (32.0%) 1,246 (34.8%) 111 (52.1%) 8 (44.4%) 2 to <4 years 5,886 (54.4%) 1,857 (51.9%) 81 (38.0%) 7 (38.9%) 4 to <6 years 1,444 (13.3%) 470 (13.1%) 21 (9.9%) 3 (16.7%) ≤5 years 23 (0.2%) 6 (0.2%) 0 (0.0%) 0 (0.0%) Gender Female 4,999 (46.2%) 1,670 (46.7%) 98 (46.0%) 6 (33.3%) Male 5,796 (53.6%) 1,904 (53.2%) 115 (54.0%) 12 (66.7%) Unknown 26 (0.2%) 5 (0.1%) 0 (0.0%) 0 (0.0%)

14

DEMOGRAPHI CS

2018

All Exposures (n=9,376) Exposures Involving HCF Evaluation (n=3,250) Exposures Involving HCF Admission (n=178) Exposures with Severe Medical Outcomes (n=8) Age Mean (SD), years 2.3 (1.04) 2.3 (1.04) 2.0 (1.01) 1.8 (0.67) Median, years 2.0 2.0 2.0 1.9 Age (categorical) <2 years 2,990 (31.9%) 1,109 (34.1%) 82 (46.1%) 4 (50.0%) 2 to <4 years 5,099 (54.4%) 1,711 (52.6%) 78 (43.8%) 4 (50.0%) 4 to <6 years 1,268 (13.5%) 427 (13.1%) 17 (9.6%) 0 (0.0%) ≤5 years 19 (0.2%) 3 (0.1%) 1 (0.6%) 0 (0.0%) Gender Female 4,356 (46.5%) 1,531 (47.1%) 85 (47.8%) 1 (12.5%) Male 5,002 (53.3%) 1,714 (52.7%) 92 (51.7%) 7 (87.5%) Unknown 18 (0.2%) 5 (0.2%) 1 (0.6%) 0 (0.0%)

15

Baseline Period (July 2012- June 2013) (n=10,229) 2017 Period (n=10,821) 2018 Period (n=9,376) Post Period 2017- 2018 (n=20,197) Route of Exposurea Ingestion 9,248 (90.4%) 8,900 (82.2%) Aspiration (with ingestion) 45 (0.4%) 24 (0.2%) Inhalation/Nasal 30 (0.3%) 30 (0.3%) Ocular 1,357 (13.3%) 2,370 (21.9%) Dermal 1,047 (10.2%) 1,810 (16.7%) Parenteral 0 (0.0%) 0 (0.0%) Other 1 (<0.1%) 11 (0.1%) Unknown 2 (<0.1%) 6 (0.1%)

ROUTE OF EXPOSURE

16

aA single exposure may involve more than one route.

ROUTE OF EXPOSURE

Baseline Period (July 2012- June 2013) (n=10,229) 2017 Period (n=10,821) 2018 Period (n=9,376) Post Period 2017- 2018 (n=20,197) Route of Exposurea Ingestion 9,248 (90.4%) 8,900 (82.2%) 7,649 (81.6%) 16,549 (81.9%) Aspiration (with ingestion) 45 (0.4%) 24 (0.2%) 22 (0.2%) 46 (0.2%) Inhalation/Nasal 30 (0.3%) 30 (0.3%) 41 (0.4%) 71 (0.4%) Ocular 1,357 (13.3%) 2,370 (21.9%) 2,214 (23.6%) 4,584 (22.7%) Dermal 1,047 (10.2%) 1,810 (16.7%) 1,620 (17.3%) 3,430 (17.0%) Parenteral 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) Other 1 (<0.1%) 11 (0.1%) 7 (0.1%) 18 (0.1%) Unknown 2 (<0.1%) 6 (0.1%) 12 (0.1%) 18 (0.1%)

17

aA single exposure may involve more than one route.

COMPARI SON OF ROUTE

Routea Baseline Period (July 2012- June 2013) (n=10,229) Post Period 2018 (n=9,376) p-value Ingestion 9,248 (90.4%) 7,649 (81.6%) <0.001 Aspiration (with ingestion) 45 (0.4%) 22 (0.2%) 0.014 Ocular 1,357 (13.3%) 2,214 (23.6%) <0.001 Dermal 1,047 (10.2%) 1,620 (17.3%) <0.001 Other/ Unknown 33 (0.3%) 60 (0.6%) 0.001

18

aA single exposure may involve more than one route.

COMPARI SON OF ROUTE

Routea Baseline Period (July 2012- June 2013) (n=10,229) Post Period 2017-2018 (n=20,197) p-value Ingestion 9,248 (90.4%) 16,549 (81.9%) <0.001 Aspiration (with ingestion) 45 (0.4%) 46 (0.2%) <0.001 Ocular 1,357 (13.3%) 4,584 (22.7%) <0.001 Dermal 1,047 (10.2%) 3,430 (17.0%) <0.001 Other/ Unknown 33 (0.3%) 107 (0.5%) 0.077

19

aA single exposure may involve more than one route.

ROUTE OF EXPOSURE

2017

All Exposures (n=10,821) Exposures Involving HCF Evaluation (n=3,579) Exposures Involving HCF Admission (n=213) Exposures with Severe Medical Outcomes (n=18) Route of Exposurea Ingestion 8,900 (82.2%) 2,669 (74.6%) 193 (90.6%) 12 (66.7%) Aspiration (w/ ingestion) 24 (0.2%) 15 (0.4%) 5 (2.3%) 2 (11.1%) Inhalation/Nasal 30 (0.3%) 8 (0.2%) 1 (0.5%) 0 (0.0%) Ocular 2,370 (21.9%) 1,187 (33.2%) 35 (16.4%) 8 (44.4%) Dermal 1,810 (16.7%) 516 (14.4%) 24 (11.3%) 3 (16.7%) Parenteral 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) Other 11 (0.1%) 6 (0.2%) 0 (0.0%) 0 (0.0%) Unknown 6 (0.1%) 2 (0.1%) 1 (0.5%) 0 (0.0%)

20

aA single exposure may involve more than one route.

ROUTE OF EXPOSURE

2018

All Exposures (n=9,376) Exposures Involving HCF Evaluation (n=3,250) Exposures Involving HCF Admission (n=178) Exposures with Severe Medical Outcomes (n=8) Route of Exposurea Ingestion 7,649 (81.6%) 2,404 (74.0%) 161 (90.4%) 6 (75.0%) Aspiration (w/ ingestion) 22 (0.2%) 17 (0.5%) 4 (2.2%) 0 (0.0%) Inhalation/Nasal 41 (0.4%) 22 (0.7%) 1 (0.6%) 0 (0.0%) Ocular 2,214 (23.6%) 1,160 (35.7%) 32 (18.0%) 4 (50.0%) Dermal 1,620 (17.3%) 544 (16.7%) 23 (12.9%) 2 (25.0%) Parenteral 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) Other 7 (0.1%) 2 (0.1%) 0 (0.0%) 0 (0.0%) Unknown 12 (0.1%) 2 (0.1%) 0 (0.0%) 0 (0.0%)

21

aA single exposure may involve more than one route.

LEVEL OF CARE

22

Baseline Period (July 2012- June 2013) (n=10,229) 2017 Period (n=10,821) 2018 Period (n=9,376) Post Period 2017-2018 (n=20,197) Recommended to or Received HCF Care Yes 4,795 (46.9%) 4,086 (37.8%) Level of HCF Carea Treated/evaluated and released 3,783 (78.9%) 3,366 (82.4%) Admitted to non-critical care unit 251 (5.2%) 151 (3.7%) Admitted to critical care unit 207 (4.3%) 62 (1.5%) Refused referral/did not arrive at HCF 168 (3.5%) 140 (3.4%) Patient lost to follow-up/left AMA 386 (8.1%) 367 (9.0%)

aOf cases referred for HCF care.

LEVEL OF CARE

23

Baseline Period (July 2012- June 2013) (n=10,229) 2017 Period (n=10,821) 2018 Period (n=9,376) Post Period 2017-2018 (n=20,197) Recommended to or Received HCF Care Yes 4,795 (46.9%) 4,086 (37.8%) 3,703 (39.5%) 7,789 (38.6%) Level of HCF Carea Treated/evaluated and released 3,783 (78.9%) 3,366 (82.4%) 3,072 (83.0%) 6,438 (82.7%) Admitted to non-critical care unit 251 (5.2%) 151 (3.7%) 117 (3.2%) 268 (3.4%) Admitted to critical care unit 207 (4.3%) 62 (1.5%) 60 (1.6%) 122 (1.6%) Refused referral/did not arrive at HCF 168 (3.5%) 140 (3.4%) 111 (3.0%) 251 (3.2%) Patient lost to follow-up/left AMA 386 (8.1%) 367 (9.0%) 342 (9.2%) 709 (9.1%)

aOf cases referred for HCF care.

COMPARI SON OF LEVEL OF CARE

Baseline Period (July 2012- June 2013) (n=10,229) Post Period 2018 (n=9,376) p-value Recommended to or Received HCF Care Yes 4,795 (46.9%) 3,703 (39.5%) <0.001 Level of HCF Carea Treated/evaluated and released 3,783 (78.9%) 3,072 (83.0%) <0.001 Admitted to non-critical care unit 251 (5.2%) 117 (3.2%) Admitted to critical care unit 207 (4.3%) 60 (1.6%) Patient refused referral/did not arrive at HCF 168 (3.5%) 111 (3.0%) Patient lost to follow-up/left AMA 386 (8.1%) 342 (9.2%)

24

aOf cases referred for HCF care.

COMPARI SON OF LEVEL OF CARE

Baseline Period (July 2012- June 2013) (n=10,229) Post Period 2017-2018 (n=20,197) p-value Recommended to or Received HCF Care Yes 4,795 (46.9%) 7,789 (38.6%) <0.001 Level of HCF Carea Treated/evaluated and released 3,783 (78.9%) 6,438 (82.7%) <0.001 Admitted to non-critical care unit 251 (5.2%) 268 (3.4%) Admitted to critical care unit 207 (4.3%) 122 (1.6%) Patient refused referral/did not arrive at HCF 168 (3.5%) 251 (3.2%) Patient lost to follow-up/left AMA 386 (8.1%) 709 (9.1%)

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aOf cases referred for HCF care.

MEDI CAL OUTCOME

26

Baseline Period (July 2012- June 2013) (n=10,229) 2017 Period (n=10,821) 2018 Period (n=9,376) Post Period 2017-2018 (n=20,197) Followed to a Known Outcome 7,908 (77.3%) 7,476 (69.1%) Death 1 (<0.1%) 0 (0.0%) Major Effect 63 (0.6%) 18 (0.2%) Moderate Effect 740 (7.2%) 520 (4.8%) Minor Effect 5,267 (51.5%) 4,613 (42.6%) No Effect or Unrelated Effect 1,837 (18.0%) 2,325 (21.5%) Not Followed to Known Outcome 2,321 (22.7%) 3,345 (30.9%)

MEDI CAL OUTCOME

27

Baseline Period (July 2012- June 2013) (n=10,229) 2017 Period (n=10,821) 2018 Period (n=9,376) Post Period (n=20,197) Followed to a Known Outcome 7,908 (77.3%) 7,476 (69.1%) 6,281 (67.0%) 13,757 (68.1%) Death 1 (<0.1%) 0 (0.0%) 0 (0.0%) 0 (0.0%) Major Effect 63 (0.6%) 18 (0.2%) 8 (0.1%) 26 (0.1%) Moderate Effect 740 (7.2%) 520 (4.8%) 485 (5.2%) 1,005 (5.0%) Minor Effect 5,267 (51.5%) 4,613 (42.6%) 3,731 (39.8%) 8,344 (41.3%) No Effect or Unrelated Effect 1,837 (18.0%) 2,325 (21.5%) 2,057 (21.9%) 4,382 (21.7%) Not Followed to Known Outcome 2,321 (22.7%) 3,345 (30.9%) 3,095 (33.0%) 6,440 (31.9%)

COMPARI SON OF MEDI CAL OUTCOME

Baseline Period (July 2012- June 2013) (n=10,229) Post Period 2018 (n=9,376) p-value Followed to a Known Outcome 7,908 (77.3%) 6,281 (67.0%) <0.001 Death 1 (<0.1%) 0 (0.0%) <0.001 Major Effect 63 (0.6%) 8 (0.1%) Moderate Effect 740 (7.2%) 485 (5.2%) Minor Effect 5,267 (51.5%) 3,731 (39.8%) No Effect or Unrelated Effect 1,837 (18.0%) 2,057 (21.9%) Not Followed to Known Outcome 2,321 (22.7%) 3,095 (33.0%) <0.001

28

COMPARI SON OF MEDI CAL OUTCOME

Baseline Period (July 2012- June 2013) (n=10,229) Post Period 2017-2018 (n=20,197) p-value Followed to a Known Outcome 7,908 (77.3%) 13,757 (68.1%) <0.001 Death 1 (<0.1%) 0 (0.0%) <0.001 Major Effect 63 (0.6%) 26 (0.1%) Moderate Effect 740 (7.2%) 1,005 (5.0%) Minor Effect 5,267 (51.5%) 8,344 (41.3%) No Effect or Unrelated Effect 1,837 (18.0%) 4,382 (21.7%) Not Followed to Known Outcome 2,321 (22.7%) 6,440 (31.9%) <0.001

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MOST COMMON RELATED CLI NI CAL EFFECTS

Baseline Period (July 2012- June 2013) (n=10,229) 2017 Period (n=10,821) 2018 Period (n=9,376) Post Period 2017- 2018 (n=20,197) Vomiting 4,917 (48.1%) 3,271 (30.2%) Cough/choke 1,328 (13.0%) 800 (7.4%) Ocular - Irritation/pain 1,105 (10.8%) 1,945 (18.0%) Red eye/conjunctivitis 679 (6.6%) 1,223 (11.3%) Drowsiness/lethargy 517 (5.1%) 197 (1.8%) Nausea 467 (4.6%) 283 (2.6%) Other 436 (4.3%) 267 (2.5%) Oral irritation 362 (3.5%) 261 (2.4%) Throat irritation 243 (2.4%) 113 (1.0%) Erythema/flushed 203 (2.0%) 254 (2.3%) Edema 173 (1.7%) 207 (1.9%) Excess secretions 167 (1.6%) 85 (0.8%) Corneal abrasion 154 (1.5%) 190 (1.8%) Dermal - Irritation/pain 152 (1.5%) 182 (1.7%) Diarrhea 147 (1.4%) 123 (1.1%)

30

MOST COMMON RELATED CLI NI CAL EFFECTS

Baseline Period (July 2012- June 2013) (n=10,229) 2017 Period (n=10,821) 2018 Period (n=9,376) Post Period 2017- 2018 (n=20,197) Vomiting 4,917 (48.1%) 3,271 (30.2%) 1,799 (19.2%) 5,070 (25.1%) Cough/choke 1,328 (13.0%) 800 (7.4%) 544 (5.8%) 1,344 (6.7%) Ocular - Irritation/pain 1,105 (10.8%) 1,945 (18.0%) 1,350 (14.4%) 3,295 (16.3%) Red eye/conjunctivitis 679 (6.6%) 1,223 (11.3%) 822 (8.8%) 2,045 (10.1%) Drowsiness/lethargy 517 (5.1%) 197 (1.8%) 100 (1.1%) 297 (1.5%) Nausea 467 (4.6%) 283 (2.6%) 173 (1.8%) 456 (2.3%) Other 436 (4.3%) 267 (2.5%) 198 (2.1%) 465 (2.3%) Oral irritation 362 (3.5%) 261 (2.4%) 195 (2.1%) 456 (2.3%) Throat irritation 243 (2.4%) 113 (1.0%) 89 (0.9%) 202 (1.0%) Erythema/flushed 203 (2.0%) 254 (2.3%) 190 (2.0%) 444 (2.2%) Edema 173 (1.7%) 207 (1.9%) 125 (1.3%) 332 (1.6%) Excess secretions 167 (1.6%) 85 (0.8%) 68 (0.7%) 153 (0.8%) Corneal abrasion 154 (1.5%) 190 (1.8%) 138 (1.5%) 328 (1.6%) Dermal - Irritation/pain 152 (1.5%) 182 (1.7%) 101 (1.1%) 283 (1.4%) Diarrhea 147 (1.4%) 123 (1.1%) 72 (0.8%) 195 (1.0%)

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OTHER CLI NI CALLY MEANI NGFUL CLI NI CAL EFFECTS

32

Baseline Period (July 2012- June 2013) (n=10,229) 2017 Period (n=10,821) 2018 Period (n=9,376) Post Period 2017- 2018 (n=20,197) Dyspnea 130 (1.3%) 36 (0.3%) 21 (0.2%) 57 (0.3%) Bronchospasm 83 (0.8%) 25 (0.2%) 13 (0.1%) 38 (0.2%) Burns 41 (0.4%) 34 (0.3%) 24 (0.3%) 58 (0.3%) Respiratory depression 39 (0.4%) 3 (<0.1%) 2 (<0.1%) 5 (<0.1%) Pneumonitis 24 (0.2%) 5 (<0.1%) 2 (<0.1%) 7 (<0.1%) Oral burns (including lips) 20 (0.2%) 10 (0.1%) 8 (0.1%) 18 (0.1%) Coma 17 (0.2%) 1 (<0.1%) 0 (0.0%) 1 (<0.1%) Esophageal injury 10 (0.1%) 4 (<0.1%) 8 (0.1%) 12 (0.1%) Visual defect 8 (0.1%) 3 (<0.1%) 3 (<0.1%) 6 (<0.1%) Burns 2 - 3 degree 6 (0.1%) 14 (0.1%) 4 (<0.1%) 18 (0.1%) Seizure (single) 3 (<0.1%) 0 (0.0%) 0 (0.0%) 0 (0.0%) Hypotension 2 (<0.1%) 0 (0.0%) 2 (<0.1%) 2 (<0.1%) Pulmonary edema 2 (<0.1%) 0 (0.0%) 0 (0.0%) 0 (0.0%)

COMPARI SON OF FREQUENCY OF RELATED CLI NI CAL EFFECT

33

Baseline Period (July 2012- June 2013) (n=10,229) 2017 Period (n=10,821) 2018 Period (n=9,376) Post Period 2017- 2018 (n=20,197) Related Clinical Effect(s) Reported 7,119 (69.6%) 6,348 (58.7%) Related Clinical Effect(s) per Case 1.7 (1.13) 1.6 (0.91)

COMPARI SON OF FREQUENCY OF RELATED CLI NI CAL EFFECT

34

Baseline Period (July 2012- June 2013) (n=10,229) 2017 Period (n=10,821) 2018 Period (n=9,376) Post Period 2017- 2018 (n=20,197) Related Clinical Effect(s) Reported 7,119 (69.6%) 6,348 (58.7%) 3,994 (42.6%) 10,342 (51.2%) Related Clinical Effect(s) per Case 1.7 (1.13) 1.6 (0.91) 1.6 (0.91) 1.6 (0.91)

MOST COMMONLY PERFORMED THERAPI ES

Baseline Period (July 2012- June 2013) (n=10,229) 2017 Period (n=10,821) 2018 Period (n=9,376) Post Period 2017-2018 (n=20,197) Dilute/irrigate/wash 7,776 (76.0%) 8,483 (78.4%) Food/snack 1,088 (10.6%) 1,214 (11.2%) Other 713 (7.0%) 449 (4.1%) Antibiotics 243 (2.4%) 260 (2.4%) Fluids, IV 224 (2.2%) 69 (0.6%) Antiemetics 137 (1.3%) 87 (0.8%) Other emetic 123 (1.2%) 176 (1.6%) Oxygen 115 (1.1%) 18 (0.2%) Bronchodilators 104 (1.0%) 23 (0.2%) Steroids 97 (0.9%) 50 (0.5%) Intubation 63 (0.6%) 7 (0.1%) Ventilator 60 (0.6%) 7 (0.1%) Antihistamines 47 (0.5%) 24 (0.2%) Sedation (other) 42 (0.4%) 16 (0.1%) Calcium 39 (0.4%) 30 (0.3%)

35

MOST COMMONLY PERFORMED THERAPI ES

Baseline Period (July 2012- June 2013) (n=10,229) 2017 Period (n=10,821) 2018 Period (n=9,376) Post Period 2017-2018 (n=20,197) Dilute/irrigate/wash 7,776 (76.0%) 8,483 (78.4%) 5,525 (58.9%) 14,008 (69.4%) Food/snack 1,088 (10.6%) 1,214 (11.2%) 778 (8.3%) 1,992 (9.9%) Other 713 (7.0%) 449 (4.1%) 279 (3.0%) 728 (3.6%) Antibiotics 243 (2.4%) 260 (2.4%) 198 (2.1%) 458 (2.3%) Fluids, IV 224 (2.2%) 69 (0.6%) 58 (0.6%) 127 (0.6%) Antiemetics 137 (1.3%) 87 (0.8%) 57 (0.6%) 144 (0.7%) Other emetic 123 (1.2%) 176 (1.6%) 135 (1.4%) 311 (1.5%) Oxygen 115 (1.1%) 18 (0.2%) 6 (0.1%) 24 (0.1%) Bronchodilators 104 (1.0%) 23 (0.2%) 12 (0.1%) 35 (0.2%) Steroids 97 (0.9%) 50 (0.5%) 35 (0.4%) 85 (0.4%) Intubation 63 (0.6%) 7 (0.1%) 3 (<0.1%) 10 (<0.1%) Ventilator 60 (0.6%) 7 (0.1%) 3 (<0.1%) 10 (<0.1%) Antihistamines 47 (0.5%) 24 (0.2%) 25 (0.3%) 49 (0.2%) Sedation (other) 42 (0.4%) 16 (0.1%) 16 (0.2%) 32 (0.2%) Calcium 39 (0.4%) 30 (0.3%) 20 (0.2%) 50 (0.2%)

36

SCENARI O

Was a Scenario Reported? Baseline Period (July 2012- June 2013) (n=10,229) 2017 Period (n=10,821) 2018 Period (n=9,376) Post Period 2017-2018 (n=20,197) Yes 562 (5.5%) 724 (6.7%)

37

Scenario: a description of the events that led to the reported exposure

SCENARI O

Was a Scenario Reported? Baseline Period (July 2012- June 2013) (n=10,229) 2017 Period (n=10,821) 2018 Period (n=9,376) Post Period 2017-2018 (n=20,197) Yes 562 (5.5%) 724 (6.7%) 500 (5.3%) 1,224 (6.1%)

38

Scenario: a description of the events that led to the reported exposure

MOST COMMONLY REPORTED SCENARI OS

Baseline Period (July 2012- June 2013) (n=10,229) 2017 Period (n=10,821) 2018 Period (n=9,376) Post Period 2017-2018 (n=20,197) Stored within sight of child 193 (1.9%) 296 (2.7%) Other 167 (1.6%) 185 (1.7%) Product temporarily open because product was in use 58 (0.6%) 89 (0.8%) Product stored inappropriately (other than above) 49 (0.5%) 58 (0.5%) Product always left out 38 (0.4%) 36 (0.3%) Stored in unlocked, low cabinet in kitchen or bathroom 23 (0.2%) 21 (0.2%) Scenario unknown (not allowed with

• ther options)

14 (0.1%) 7 (0.1%) Child caused exposure (gave to sib or pet, etc) 12 (0.1%) 20 (0.2%) Container transfer involved 6 (0.1%) 2 (<0.1%)

39

MOST COMMONLY REPORTED SCENARI OS

Baseline Period (July 2012- June 2013) (n=10,229) 2017 Period (n=10,821) 2018 Period (n=9,376) Post Period 2017-2018 (n=20,197) Stored within sight of child 193 (1.9%) 296 (2.7%) 171 (1.8%) 467 (2.3%) Other 167 (1.6%) 185 (1.7%) 127 (1.4%) 312 (1.5%) Product temporarily open because product was in use 58 (0.6%) 89 (0.8%) 57 (0.6%) 146 (0.7%) Product stored inappropriately (other than above) 49 (0.5%) 58 (0.5%) 45 (0.5%) 103 (0.5%) Product always left out 38 (0.4%) 36 (0.3%) 26 (0.3%) 62 (0.3%) Stored in unlocked, low cabinet in kitchen or bathroom 23 (0.2%) 21 (0.2%) 26 (0.3%) 47 (0.2%) Scenario unknown (not allowed with

• ther options)

14 (0.1%) 7 (0.1%) 9 (0.1%) 16 (0.1%) Child caused exposure (gave to sib or pet, etc) 12 (0.1%) 20 (0.2%) 20 (0.2%) 40 (0.2%) Container transfer involved 6 (0.1%) 2 (<0.1%) 1 (<0.1%) 3 (<0.1%)

40

POPULATI ON ADJUSTED RATES

41

• Data Source: U.S. Census
• Age: <6 years
• Date Range: 01 July 2012 to 31 December 2018

(NEW data: 01 January 2018 to 31 December 2018)

• Evaluation: Cumulative rate of exposures per

100,000 US children <6 years of age in baseline vs. post period

ALL EXPOSURES AND POPULATI ON COUNTS BY QUARTER ( 0 1 JULY 2 0 1 2 TO 3 1 DECEMBER 2 0 1 8 )

42

COUNTS

POPULATI ON-ADJUSTED RATES OF ALL EXPOSURES BY QUARTER ( 0 1 JULY 2 0 1 2 TO 3 1 DECEMBER 2 0 1 8 )

43

RATES

EXPOSURES I NVOLVI NG HEALTHCARE FACI LI TY EVALUATI ON AND POPULATI ON COUNTS BY QUARTER ( 0 1 JULY 2 0 1 2 TO 3 1 DECEMBER 2 0 1 8 )

44

COUNTS

45

POPULATI ON-ADJUSTED RATES OF EXPOSURES I NVOLVI NG HEALTHCARE FACI LI TY EVALUATI ON BY QUARTER ( 0 1 JULY 2 0 1 2 TO 3 1 DECEMBER 2 0 1 8 ) RATES

EXPOSURES I NVOLVI NG HEALTHCARE FACI LI TY ADMI SSI ON AND POPULATI ON COUNTS BY QUARTER ( 0 1 JULY 2 0 1 2 TO 3 1 DECEMBER 2 0 1 8 )

46

COUNTS

POPULATI ON-ADJUSTED RATES OF EXPOSURES I NVOLVI NG HEALTHCARE FACI LI TY ADMI SSI ON BY QUARTER ( 0 1 JULY 2 0 1 2 TO 3 1 DECEMBER 2 0 1 8 )

47

RATES

EXPOSURES I NVOLVI NG SEVERE MEDI CAL OUTCOMES AND POPULATI ON COUNTS BY QUARTER ( 0 1 JULY 2 0 1 2 TO 3 1 DECEMBER 2 0 1 8 )

48

COUNTS

POPULATI ON-ADJUSTED RATES OF EXPOSURES RESULTI NG I N SEVERE MEDI CAL OUTCOMES BY QUARTER ( 0 1 JULY 2 0 1 2 TO 3 1 DECEMBER 2 0 1 8 )

49

RATES

50

ANNUAL EXPOSURE COUNTS BY LEVEL OF SEVERI TY ( 0 1 JULY 2 0 1 2 TO 3 1 DECEMBER 2 0 1 8 )

Exposures

COUNTS

51

ANNUAL POPULATI ON-ADJUSTED RATES OF EXPOSURE BY LEVEL OF SEVERI TY ( 0 1 JULY 2 0 1 2 TO 3 1 DECEMBER 2 0 1 8 ) RATES

52

ANNUAL POPULATI ON-ADJUSTED RATES OF EXPOSURE – HCF ADMI SSI ON AND MAJOR MEDI CAL OUTCOME ONLY ( 0 1 JULY 2 0 1 2 TO 3 1 DECEMBER 2 0 1 8 ) RATES

RATE PER 1 0 0 ,0 0 0 CHI LDREN < 6 YEARS OF AGE

Baseline Period (July 2012- June 2013) Cumulative Rate 2017 Period Cumulative Rate 2018 Period Cumulative Rate Post Period 2017-2018 Cumulative Rate All Exposures 42.499 (CI 41.684, 43.331) 45.199 (44.355, 46.058) HCF Evaluation 17.620 (CI 17.098, 18.159) 14.949 (CI 14.467, 15.447) HCF Admission 1.903 (CI 1.736, 2.085) 0.890 (0.778, 1.018) Severe Medical Outcomes 0.266 (CI 0.208, 0.340) 0.075 (0.047, 0.119)

53

RATE PER 1 0 0 ,0 0 0 CHI LDREN < 6 YEARS OF AGE

Baseline Period (July 2012- June 2013) Cumulative Rate 2017 Period Cumulative Rate 2018 Period Cumulative Rate Post Period 2017-2018 Cumulative Rate All Exposures 42.499 (CI 41.684, 43.331) 45.199 (44.355, 46.058) 39.142 (38.357, 39.942) 42.169 (CI 41.592, 42.755) HCF Evaluation 17.620 (CI 17.098, 18.159) 14.949 (CI 14.467, 15.447) 13.568 (13.109, 14.042) 14.258 (CI13.924, 14.600) HCF Admission 1.903 (CI 1.736, 2.085) 0.890 (0.778, 1.018) 0.743 (0.642, 0.861) 0.816 (CI 0.739, 0.901) Severe Medical Outcomes 0.266 (CI 0.208, 0.340) 0.075 (0.047, 0.119) 0.033 (0.017, 0.067) 0.054 (CI 0.037, 0.080)

54

COMPARI SON OF CUMULATI VE RATES PER 1 0 0 ,0 0 0 CHI LDREN < 6 YEARS OF AGE

Baseline Period (July 2012- June 2013) Cumulative Rate Post Period 2018 Cumulative Rate % Change (95% CI) p-value All Exposures 42.512 39.142

• 7.9%

(-10.5%, -5.3%) <0.001 HCF Evaluation 17.626 13.568

• 23.0%

(-26.5%, -19.4%) <0.001 HCF Admission 1.903 0.743

• 61.0%

(-67.2%, -53.6%) <0.001 Severe Medical Outcomes 0.266 0.033

• 87.4%

(-94.0%, -73.8%) <0.001

55

COMPARI SON OF CUMULATI VE RATES PER 1 0 0 ,0 0 0 CHI LDREN < 6 YEARS OF AGE

Baseline Period (July 2012- June 2013) Cumulative Rate Post Period 2017-2018 Cumulative Rate % Change (95% CI) p-value All Exposures 42.512 42.169

• 0.8%

(-3.1%, 1.6%) 0.505 HCF Evaluation 17.626 14.258

• 19.1%

(-22.1%, -15.9%) <0.001 HCF Admission 1.903 0.816

• 57.1%

(-62.5%, -50.9%) <0.001 Severe Medical Outcomes 0.266 0.054

• 79.6%

(-87.1%, -67.8%) <0.001

56

Sales-Adjusted Rates

• Data Source: Nielsen Strategic Planner
• Substance: Liquid laundry detergent packets
• Date Range: 22 July 2012 to 30 December 2018

(Four Week Intervals) (NEW data: 01 January 2018 to 31 December 2018)

• Evaluation: Cumulative rate of exposures per

1,000,000 packets sold in the baseline vs. post period

ALL EXPOSURES AND SALES COUNTS BY FOUR W EEK I NTERVAL ( 2 2 JULY 2 0 1 2 TO 3 0 DECEMBER 2 0 1 8 )

58

COUNTS

59

SALES-ADJUSTED RATES OF ALL EXPOSURES BY FOUR W EEK I NTERVAL ( 2 2 JULY TO 3 0 DECEMBER 2 0 1 8 ) RATES

EXPOSURES I NVOLVI NG HEALTHCARE FACI LI TY EVALUATI ON AND SALES COUNTS BY FOUR W EEK I NTERVAL ( 2 2 JULY 2 0 1 2 TO 3 0 DECEMBER 2 0 1 8 )

60

COUNTS

SALES-ADJUSTED RATES OF EXPOSURES I NVOLVI NG HEALTHCARE FACI LI TY EVALUATI ON BY FOUR W EEK I NTERVAL ( 2 2 JULY 2 0 1 2 TO 3 0 DECEMBER 2 0 1 8 )

61

RATES

EXPOSURES I NVOLVI NG HEALTHCARE FACI LI TY ADMI SSI ON AND SALES COUNTS BY FOUR W EEK I NTERVAL ( 2 2 JULY 2 0 1 2 TO 3 0 DECEMBER 2 0 1 8 )

62

COUNTS

SALES-ADJUSTED RATES OF EXPOSURES I NVOLVI NG HEALTHCARE FACI LI TY ADMI SSI ON BY FOUR W EEK I NTERVAL ( 2 2 JULY 2 0 1 2 TO 3 0 DECEMBER 2 0 1 8 )

63

RATES

EXPOSURES I NVOLVI NG SEVERE MEDI CAL OUTCOMES AND SALES COUNTS BY FOUR W EEK I NTERVAL ( 2 2 JULY 2 0 1 2 TO 3 0 DECEMBER 2 0 1 8 )

64

COUNTS

SALES-ADJUSTED RATES OF EXPOSURES RESULTI NG I N SEVERE MEDI CAL OUTCOMES BY FOUR W EEK I NTERVAL ( 2 2 JULY 2 0 1 2 TO 3 0 DECEMBER 2 0 1 8 )

65

RATES

66

ANNUAL EXPOSURE COUNTS BY LEVEL OF SEVERI TY ( 0 1 JULY 2 0 1 2 TO 3 1 DECEMBER 2 0 1 8 )

Exposures

COUNTS

67

ANNUAL SALES-ADJUSTED RATES OF EXPOSURE BY LEVEL OF SEVERI TY ( 0 1 JULY 2 0 1 2 TO 3 1 DECEMBER 2 0 1 8 ) RATES

68

ANNUAL SALES-ADJUSTED RATES OF EXPOSURE BY LEVEL OF SEVERI TY ( 0 1 JULY 2 0 1 2 TO 3 1 DECEMBER 2 0 1 8 ) RATES

RATE PER 1 ,0 0 0 ,0 0 0 PACKETS SOLD

Baseline Period (July 2012- June 2013) Cumulative Rate 2017 Period Cumulative Rate 2018 Period Cumulative Rate Post Period 2017-2018 Cumulative Rate All Exposures 4.920 (CI 4.822, 5.020) 2.296 (CI 2.253, 2.340) HCF Evaluation 2.026 (CI 1.963, 2.090) 0.759 (0.735, 0.785) HCF Admission 0.218 (CI 0.198, 0.240) 0.045 (0.040, 0.052) Severe Medical Outcomes 0.030 (CI 0.023, 0.038) 0.004 (0.002, 0.006)

69

RATE PER 1 ,0 0 0 ,0 0 0 PACKETS SOLD

Baseline Period (July 2012- June 2013) Cumulative Rate 2017 Period Cumulative Rate 2018 Period Cumulative Rate Post Period 2017-2018 Cumulative Rate All Exposures 4.920 (CI 4.822, 5.020) 2.296 (CI 2.253, 2.340) 1.901 (1.863, 1.940) 2.094 (CI 2.065, 2.123) HCF Evaluation 2.026 (CI 1.963, 2.090) 0.759 (0.735, 0.785) 0.659 (0.637, 0.682) 0.708 (CI 0.692, 0.725) HCF Admission 0.218 (CI 0.198, 0.240) 0.045 (0.040, 0.052) 0.036 (0.031, 0.042) 0.041 (CI 0.037, 0.045) Severe Medical Outcomes 0.030 (CI 0.023, 0.038) 0.004 (0.002, 0.006) 0.002 (<0.001, 0.003) 0.003 (CI 0.002, 0.004)

70

COMPARI SON OF CUMULATI VE RATES PER 1 ,0 0 0 ,0 0 0 PACKETS SOLD

Baseline Period (July 2012- June 2013) Cumulative Rate Post Period 2018 Cumulative Rate % Change (95% CI) p-value All Exposures 4.920 1.901

• 61.4%

(-62.5%, -60.2%) <0.001 HCF Evaluation 2.026 0.659

• 67.4%

(-68.9%, -65.9%) <0.001 HCF Admission 0.218 0.036

• 83.5%

(-86.2%, -80.3%) <0.001 Severe Medical Outcomes 0.030 0.002

• 94.5%

(-97.4%, -88.5%) <0.001

71

COMPARI SON OF CUMULATI VE RATES PER 1 ,0 0 0 ,0 0 0 PACKETS SOLD

Baseline Period (July 2012- June 2013) Cumulative Rate Post Period 2017-2018 Cumulative Rate % Change (95% CI) p-value All Exposures 4.920 2.094

• 57.4%

(-58.5%, -56.4%) <0.001 HCF Evaluation 2.026 0.708

• 65.0%

(-66.4%, -63.6%) <0.001 HCF Admission 0.218 0.041

• 81.4%

(-83.8%, -78.7%) <0.001 Severe Medical Outcomes 0.030 0.003

• 90.9%

(-94.3%, -85.5%) <0.001

72

LI MI TATI ONS

• NPDS data is voluntary, self-reported
• Impact of changes in treatment and referral practices

unknown

• Sales data not a perfect denominator

73

THANK YOU!

Kate M. Reynolds, MPH kate.reynolds@rmpds.org