1. © Product Stewardship Institute, Inc. September 2008 PSI National Dialogue on Medical Sharps “Data” Workgroup Sacramento, CA September 23-24, 2008

2. © Product Stewardship Institute, Inc. September 2008 Workgroup Participants PSI: Scott Cassel, Sierra Fletcher (Facilitators) Angela Laramie, MA DPH Michael Mongillo, Pathacura Lisa Pompeii, University of Texas Jenny Schumann, Coalition for Safe Community Needle Disposal Karl Schumann and Bob Singley, BD David Trindell, Hoffman-La Roche 2

3. © Product Stewardship Institute, Inc. September 2008 Workgroup Process Assignments from Meeting #1 3 workgroup calls – Refined purpose – Developed workplan – Conducted research between calls – Helped develop presentation 3

4. © Product Stewardship Institute, Inc. September 2008 Purpose of this Workgroup Reach consensus on the nature & scope of the problem. 4

5. © Product Stewardship Institute, Inc. September 2008 Priority Questions Nature & Scope of the Problem Incidence of needle-sticks (Where? Who? How many?) Costs/impacts of needle-sticks Who is affected (public v. private waste haulers; other sectors?) 5

6. © Product Stewardship Institute, Inc. September 2008 Incidence of Needle-stick Injuries (outside healthcare) Data for on-the-job needle-sticks: – Workers might not report the incident to employers, leading to under-reporting of such events – Companies/agencies might not collect this data – Companies/agencies might not be willing to share these data, if collected Data on needle-sticks among the public are not available. 6

7. © Product Stewardship Institute, Inc. September 2008 2004 NIOSH Waste Workers and Bloodborne Pathogen Exposure: Executive Summary of Existing Literature NY city – needle sightings in 2001 – 1 in every 4,156 truck shifts (Lawitts, 2002) NY city – Needle-sticks in 2001 – 1 in 34,000 truck shifts (Lawitts, 2002) San Francisco – 2001 – 6 needle-stick injuries (Drda, 2002) 2006 California Department of Health Services Transforming Medical Waste Disposal Practices to Protect Public Health: Worker Health and Safety and the Implementation of Large-Scale, Off-site Steam Autoclaves April 2002 - December 2003 - 8 (12.5%) needle-stick injuries recorded by employer (out of a total of 64 injuries) http://www.cdph.ca.gov/programs/ohsep/Documents/med icalwaste.pdf Injuries Among Waste Haulers 7

8. © Product Stewardship Institute, Inc. September 2008 1990 American Journal of Public Health Turnberg, WL et al Survey of Occupational Exposure of Waste Industry Workers to Infectious Waste in Washington State 438 (47%) of 940 surveys returned 144 (33%) reported experiencing contact with blood in the year prior t o the survey 28 (6%) of 438 of workers experienced a needlestick injury in the year prior to the survey 1998 American Journal of Industrial Medicine Ivens, UI et al Injuries among Domestic Waste Collectors 667 employees; 114 injuries 1 (0.9%) injury was reported from a needle- stick Injuries Among Waste Haulers 8

9. © Product Stewardship Institute, Inc. September 2008 Costs/impacts Viability of disease outside the body According to the CDC: – HIV: less than a day – Hepatitis C: least 16 hours, but no longer than 4 days – Hepatitis B: at least 7 days www.CDC.gov/hiv www.CDC.gov/hepatitis 9

10. © Product Stewardship Institute, Inc. September 2008 Cost/impacts Disease transmission (healthcare setting) The risk of transmission of disease after a needle-stick is as follows, if from a known, positive source: – HIV is 0.3% – Hepatitis C -- 1.8% (range 0% - 7%) – Hepatitis B -- (for an unvaccinated individual) 1% to 31%, depending on infection status of the source CDC- MMWR 50(RR11); 1-42 www.cdc.gov/mmwr 10

11. © Product Stewardship Institute, Inc. September 2008 Cost/impacts of a Needle-stick Studies available for needle sticks within healthcare setting (more known factors) Direct costs range from a few hundred dollars to several thousand per incident – May include prophylaxis, cost of lost work hours, personnel treating employee, etc. Indirect costs may be 4-8 times greater than direct costs, in general (psychological, etc.) 11

12. © Product Stewardship Institute, Inc. September 2008 PSI Medical Sharps Dialogue Meeting Who is impacted: waste haulers 12 Waste industry has been focal point, no data on others impacted Employees: 27% public, 72% private (both privately owned & publicly traded) Facilities: 48% public, 52% private Size of the U.S. Solid Waste Industry, Beck (2001) 12

13. © Product Stewardship Institute, Inc. September 2008 Priority Questions Medical Sharps Use/Disposal How many sharps are used in community setting? How are they disposed of now? 13

14. © Product Stewardship Institute, Inc. September 2008 # of Sharps Sold through Retail Outlets (annual, U.S.) Injection: – Insulin Syringes = 1,425,000,000 units – Pen Needles = 786,000,000 units – About 15-17% of the above sold via mail pharmacies – Growing 11-12% annually 900 million lancets 14 Becton, Dickinson and Co.

15. © Product Stewardship Institute, Inc. September 2008 Self-injected pharmaceuticals and sharps use Developing a table of self-injected pharmaceuticals on the market – Over 25 manufacturers identified – Almost 50 different pharmaceuticals – Treating 14 different categories of illnesses/conditions – Used with various injection devices 15

16. © Product Stewardship Institute, Inc. September 2008 Current sharps disposal practices Small-scale studies over past 10+ years Range of responses – Most sharps disposed of in trash (sometimes in container) – Generally small percentages take used sharps to various locations (medical facility, pharmacy, HHW) or mail-back – Flushing not commonly cited California survey (2007) – Disposal to trash (often in container) is most commonly referenced by respondents 16

17. © Product Stewardship Institute, Inc. September 2008 PSI Medical Sharps Dialogue Meeting What can we conclude? 17 Needle-sticks are not commonly reported in the waste industry Risk of disease transmission is low We still do not know where and how often needle- sticks are occurring

18. © Product Stewardship Institute, Inc. September 2008 PSI Medical Sharps Dialogue Meeting What can we conclude? 18 However, The costs of a needle-stick can be significant (direct and indirect), and treatment is always recommended Of the large number of sharps used annually today for self-injection, most are going into the municipal solid waste stream

19. © Product Stewardship Institute, Inc. September 2008 PSI Medical Sharps Dialogue Meeting Key Question 19 Do we need more research? If so, what and why?

20. © Product Stewardship Institute, Inc. September 2008 Possible Next Steps for Workgroup 1.Continue to collect information on self- injected pharmaceuticals, devices used, etc. 2.Conduct new study: To what extent could use of safety-engineered devices reduce the risk of needle-sticks in the community? 3. Conduct new study: What is the incidence of needle-sticks in other occupations (besides waste-haulers) and the general public? 20