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  1. 1. IHS - Oklahoma City Area Office Hepatitis C Treatment & Updates HCV and harm reduction: where the rubber meets the road MARY BETH LEVIN, MPH ASSOCIATE PROFESSOR DEPARTMENT OF FAMILY MEDICINE GEORGETOWN UNIVERSITY SCHOOL OF MEDICINE
  2. 2. Conflict of Interest Disclaimer  No financial disclosures.  Opinions expressed are exclusively my own and not those of the HIS.
  3. 3. Objectives  1. Understand the evidence that syringe exchange programs are successful in preventing blood-borne illness (including hepatitis C) and serving as a bridge to treatment for substance use disorder.  2. Understand the similarities and differences between harm reduction and traditional medical models.  3. Understand various scenarios in which syringe exchange programs can operate.  4. Understand the current federal and state legislative environment for implementing syringe exchange.  5. Understand the wide-ranging political support for syringe exchange from law enforcement, faith communities, and medical providers.
  4. 4. Why should anyone care? • Here in the US, 8% of new HIV infections are due to IDU. • That’s 11 people per day. • People who inject are twice as likely to be unaware of their HIV status than the general public. • People inject all sorts of things: heroin, cocaine, methamphetamine, pain meds, silicone, hormones. • Outside of Sub-Saharan Africa, three out of ten new infections are due to IDU. • Here in the US, hep C is the leading cause of death among those living with HIV. • HCV is the leading cause of death by infectious disease in the US, more than the next 30 combined. • Hep C is the leading cause of liver transplants. • The epidemic of prescription drug use and IDU. • There are more deaths due to drug overdose than auto accidents. • Health care is a right.
  5. 5. Looking at new infections: African- Americans are 11X, Latinos are 5x, and Native Americans are 2X more likely to acquire HIV via IDU than their Caucasian counterparts. CDC, MMWR, HIV Infection Among Injection-Drug Users --- 34 States, 2004—2007, Nov 22, 2009.
  6. 6. It’s not about the needle, it’s about the people… SSPs make neighborhoods safer for everyone. They also protect the sexual partners and children of IDUs. Reggie once injected drugs, contracting HIV and hepatitis C, which were both transmitted to his wife. His youngest son contracted hepatitis C perinatally. Zee has never injected drugs. The father of her children did use needles. She found out she was positive when she gave birth to their daughter.
  7. 7. Because they have been able to access care, both Reggie and Zee have been living with HIV for more than twenty years. Reggie is working and raising his kids. Zee is working and has realized a moment she never thought she would live long enough to experience: the birth of her first grandchild. Update: Zee passed away in January, 2015. It’s not about the needle, it’s about the people…
  8. 8. But do syringe service programs prevent HCV?  Yes…  In NYC, from 1990-2001, HCV prevalence was reduced from 91% to 62%.  A case-controlled study in Tacoma demonstrated a 65% reduction.  A 2016 meta-analysis did not show a sig stat difference. But, OST alone reduced HCV by 39% and OST and SSP by 71%.  but you have a very limited window of opportunity:  After initiation of IDU  One-third became infected within one year  One-half within five
  9. 9. But how available is OST?
  10. 10. What is harm reduction? Harm reduction is a set of practical strategies that reduce negative consequences of drug use, incorporating a spectrum of strategies from safer use, to managed use to abstinence. Harm reduction strategies meet drug users "where they're at," addressing conditions of use along with the use itself. -Harm Reduction Coalition, NY, USA
  11. 11.  Is a practical strategy that attempts to reduce negative consequences of drug use and other activities.  Accepts that some will engage in dangerous activities, but does not attempt to minimize the harm or dangers involved.  Focuses on the individual and their health and wellness needs.  Places individuals in the greater social context.  Places a value on drug users having a voice in the creation of programs and policies designed to serve them. From, Jan. 24, 2011
  12. 12. Harm reduction is NOT  Harm reduction is NOT “whatever happens, happens.”  Harm reduction is NOT “anything goes”.  Harm reduction is NOT simply “meeting the client where the client is at” (it’s helping them to change behavior).  Harm reduction is NOT “Helping a person who has gotten off drugs to start using again.”  Harm reduction is NOT condoning, endorsing, or encouraging drug use.  Harm reduction is NOT legalization.
  13. 13. Harm reduction is not unique to drug use
  14. 14. There is more to harm reduction than preventing HIV and viral hep.  Prevention of injection-related wounds  Prevention of secondary infections (endocarditis, cotton fever)  Safer injection technique  Alternatives to injecting  Overdose prevention and response  Immunization  STI testing  Safer sex supplies  Case management  Treatment for substance use disorder  Employment assistance
  15. 15. Access to buprenorphine/Suboxone
  17. 17. State, local, and faith-based organizations around the country already support SSPs The following organizations support SSPs: oAmerican Medical Student Association oAmerican Academy of Family Physicians oAmerican Academy of Pediatrics oAmerican Bar Association oAmerican Medical Association oAmerican Public Health Association oAmerican Society of Addiction Medicine oInternational Red Cross-Red Crescent Society oLatino Commission on AIDS oNAACP oNational Academy of Sciences oNational Black Leadership Commission on AIDS oNational Black Police Association oNational Institute on Drug Abuse oOffice of National Drug Control Policy oPresidential Advisory Committee on AIDS oUS Conference of Mayors oWorld Bank oWorld Health Organization SSPs also enjoy support from faith communities, including: • Central Conference of American Rabbis • Episcopal Church • National Council on Jewish Women • Presbyterian Church of the United States • Society of Christian Ethics • Union for Reform Judaism • Unitarian Universalist Association • United Church of Christ • United Methodist Church, General Board of Church and Society • Regional AIDS Interfaith Network
  18. 18. State, local, and faith-based organizations around the country already support SSPs  "Syringe decriminalization and exchange is issue of compassion and justice... As people of faith, we are called to be the embodiment of that compassion and instruments of that justice in this world to offer an eternal hope. The hope that someone may live another day. The hope that they may be reconciled with their family. The hope that they can live a life free of disease. The hope that they might choose to find treatment. The hope that with that one more day, they might find their own hope for a future outside of their addiction." - Pastor James Sizemore, Lead Pastor, Catalyst Community Church, Fayetteville, North Carolina
  19. 19. Note: since this map was developed, there are now SSPs in Kentucky and West Virginia and more sites in states with programs already listed. There are already a number of programs:
  20. 20. Most funding (82%) for SSPs is public – Year of Operation 2012 2013 Total $$$ $19,431,912 $21,920,648 City Gov $ $5,789,118 $6,504,086 County Gov $ $1,538,358 $1,431,851 State Gov $ $8,391,180 $10,059,565 Foundation $ $1,966,688 $2,129,610 Individual Donations $696,947 $611,269 Out-of-pocket $ $50,525 $90,250 NASEN $ $4,150 $2,100 CBO Donation $ $28,740 $47,200 Corporate Donation $ $68,300 $157,500 Other $ $856,406 $887,218
  21. 21. It’s not just the needle, it’s about the people! SSPs provide a variety of services in addition to syringe exchange1 o Onsite medical care 1 o Screening and counseling for HIV, hepatitis C, and STIs (injection drug users are twice as likely as the general public not to know their HIV status) 1,2 o Distribution of safer sex supplies, food, and clothing 1 o Referrals to substance use treatment and support groups 1 o Medications and resources to prevent death from drug overdose 3 o Case management Selected Services Offered by SSPs Nationwide
  22. 22. SSPs Make Communities Safer for Everyone o SSPs distribute free sterile syringes to injection drug users (IDUs), which reduces the likelihood that users will share injecting equipment.1 o SSPs safely dispose of used needles, a service not typically provided by distributors such as pharmacies. o SSPs make neighborhoods safer by reducing needle-stick injuries.1
  23. 23. SSPs Protect Those who Protect Us o Needle stick injuries to law enforcement are a common occurrence. In San Diego, nearly 30% of officers have been stuck by a needle.1 o Decriminalization of syringes (and SSPs) has been tied to reduced needle stick injuries. In South Carolina, where syringes are legal, officers have experienced needle stick injuries at half the rate of their counterparts in North Carolina, where syringes are illegal.2 o In Connecticut, police officer needle stick injuries were reduced by two-thirds after the establishment of SSPs.3 o “In the cities that have adopted needle services programs, there is a dramatic reduction in needle sticks to firefighters who crawl on their hands and knees through smoke-filled rooms in search of victims.” - Charles Aughenbaugh, Jr., President, New Jersey Deputy Fire Chiefs Association, Retired Deputy Fire Chief, March 2011
  24. 24. LOCAL EXAMPLES o In Baltimore, SSPs helped reduce the number of improperly discarded syringes by almost 50%. 1 o In Portland, Oregon, the implementation of SSPs reduced the number of improperly discarded syringes by two-thirds.2 o In 2008 and 2009, Miami (which had no SSPs) saw eight times more improperly disposed syringes than San Francisco (where SSPs are available) despite the fact that San Francisco is thought to have twice as many IDUs.3
  25. 25. SSPs Do NOT lead to an increase in crime or drug use. o Neighborhoods in Baltimore with SSPs experienced an 11% decrease in break- ins and burglaries, while areas without SSPs saw an 8% increase in such crimes during the same period.1 o In Seattle, IDUs who had used SSPs were more likely to report a significant decrease (>75%) in injection drug use, to stop using injection drugs, and to remain in treatment than IDUs who had never used SSPs.2 o The same study in Seattle found that new users of the SSP were five times more likely to enter drug treatment than individuals who never utilized the program.2 Local Examples
  26. 26. o In New York City, the growth of SSPs from 1990 to 2001 was associated with a 78% decrease in HIV prevalence among IDUs.1 o During this time period, the same population saw a decrease in the prevalence of hepatitis C from 90% to 63% 2 o One study showed that within 6 months of using federally-funded SSPs, clients saw a 45% increase in employment. o In addition, SSP clients were 25% more likely to have been successfully referred to mental health treatment and prescribed medication than other SAMHSA grantees.3 o In New Jersey, 22% of the state’s SSP clients have entered drug treatment.4 SSPs Bring Results
  27. 27. The most important myth to dismantle: we can’t afford it. Every dollar invested in SSPs results in $7 in savings just by preventing new HIV infections.1 Through Medicaid, Medicare, and Ryan White, the federal government is the biggest payer of HIV care. So not only are we saving federal dollars, we are saving entitlement (Medicaid and Medicare) and discretionary (RW) funds.
  28. 28. Local Data Helps o Between 2001 and 2011, Illinois saw a drop of nearly two-thirds in new HIV cases among IDUs, averting an estimated $200 million in medical expenses.1 o In Massachusetts, there was a 54% decrease in new HIV diagnosis between 1999 and 2012, preventing 5,699 infections and saving more than $2 billion in health care costs.2 o King County (Washington State) spent $1.1 million on SSPs in 2008. If HIV was prevented among only 1% of IDUs in King County, the resulting savings in HIV treatment costs will be $70 million.3 o Washington, DC was allowed to spend its own money on SSPs in 2007. Within two years, 120 HIV infections were averted, resulting in $45.6M in savings.4 So far, incidence has been reduced by 87%. o Miami, a city without legal SSPs, published study of the costs of bacterial infections relating to IDU at Jackson Memorial Hospital. The cost was $11.4M over 12 month period.5
  29. 29. Final Talking Points This policy costs nothing: Lifting the ban does not involve additional dollars. It simply allows localities to spend their federal prevention dollars as they see fit. It may be a source of additional federal dollars in the future if additional dollars are allocated to HIV prevention. It's cost effective: For every additional dollar invested, an average of $7 dollars in HIV treatment costs are saved. This does not include other associated costs such as viral hepatitis, secondary infections (e.g. endocarditis), injection related wounds, or drug overdose. Federal dollars open doors: Federal funding is often perceived by other donors as a "seal of approval", leading to new funding streams. Federal grantees can also receive extensive technical assistance at no cost. It's about local control: States and localities know how best to respond to the epidemics of HIV, viral hepatitis, and drug overdose. It's about health disparities: African-Americans are 11x, Latinos are 5x, and Native Americans are 2X more likely to contract HIV from an infected needle than their Caucasian counterparts. SSPs are a bridge to related services: HIV testing, viral hepatitis services, treatment for substance use disorder, and drug overdose prevention and response services. The changing demographics of injection drug users: Due to the crackdown on prescription drug use, many are transitioning to heroin use. This new generation of users is more likely to be young, female, and non-urban. SSPs make neighborhoods safer for everyone: Because they provide a safe place to dispose of used needles, there are fewer injuries to civilians (kids playing in the park) and first responders alike.
  30. 30. “I understand that there will be questions, but this is common sense.” - Sister Maureen Joyce, CEO of Catholic Charities, Albany, NY Messages and Messengers: law enforcement, faith communities, and families.
  31. 31. What about pharmacies? • OTC access varies by state • Full range of SSP services are not available • Not equitably distributed (like food deserts) • Not required to stock syringes • Pharmacy has discretion about whom to serve; more likely to refuse service to people of color • False choice: we need both
  32. 32. A Brief History of the Ban o In 2009, Congress removed a 21-year prohibition on the use of federal funds to support SSPs.1 Two years later, Congress re- imposed the ban on federal funding for SSPs.2 o While the ban was lifted, federal dollars were used to support SSPs in California, Connecticut, Delaware, Illinois, Massachusetts, Minnesota, New Jersey, New Mexico, New York, Puerto Rico, Vermont, and Washington.3 o Funding came from CDC, HRSA, and SAMHSA. IHS was a potential source which wasn’t tapped. o Seen as a “seal of approval”, lifting the ban opened doors from other donors. o These dollars were used to: expand service hours, provide services in new locations, and provide additional services such as case management and overdose prevention services.
  33. 33. What exactly happened in December of 2015?  Report language "Needle Exchange Programs.—The Committee maintains its support for federal, state and local efforts to address the abuse of prescription painkillers and other opioids. The Committee is alarmed by trends in urban and rural communities which indicate a transition to injection drug use, and supports state and local efforts to mitigate the spread of related infections, such as Hepatitis and HIV/AIDS, and associated healthcare costs. The Committee believes the determination about whether to implement needle exchange programs remains a quintessentially local function, and therefore maintains its prohibition on the use of federal funds for the purchase of syringes or sterile needles as a title V general provision. The provision is modified, however, to allow existing programs in hard-hit communities to access federal funds for other program elements, including substance use counseling and referral to treatment, that support communities in their drive to end the cycle of dependency. Eligible programs must demonstrate a need or federal support based on actual cases of Hepatitis or HIV/AIDS or on conditions posing a significant risk for an outbreak."  Budget language SEC. 520. Notwithstanding any other provision of this Act, no funds appropriated in this Act shall be used to purchase sterile needles or syringes for the hypodermic injection of any illegal drug: Provided, That such limitation does not apply to the use of funds for elements of a program other than making such purchases if the relevant State or local health department, in consultation with the Centers for Disease Control and Prevention, determines that the State or local jurisdiction, as applicable, is experiencing, or is at risk for, a significant increase in hepatitis infections or an HIV outbreak due to injection drug use, and such program is operating in accordance with State and local law.  So what? So basically with this partial lift, federal dollars could go to all aspects of an SSP, except for the needles themselves. It's counter-intuitive, but not a big deal since syringes are often the least expensive part of operating an SSP. It is an improvement over how things once were. Previously, federal dollars could not be used for syringes, personnel, and housing the exchange (either a vehicle or a building). The other issue (which is just FYI) is working with the CDC to define "conditions posing a significant risk" and "hard-hit communities".
  34. 34. Where do we go from here?  HHS guidance  SAMHSA-specific guidance for Minority HIV/AIDS Initiative (MAI): ts.pdf  SAMHSA-specific guidance for block grants: pdf  CDC guidance: exchange-services.pdf  CDC Determination of Need Request info (results in 30 days):  Those that have already achieved approval: California, Colorado, Maryland, Massachusetts, Michigan, New Jersey, Pennsylvania, Utah, Vermont, Washington, West Virginia (select counties) – Kanawha County and Berkeley County
  35. 35.  What to do now?  Contact your GPO (HRSA, SAMHSA, CDC, IHS) to express interest.  Investigate the legal environment.  Apply for determination of need.  Possible funding angles: HIV/STI/Viral Hep. prevention and diagnosis, vertical transmission, bridge to SUD treatment, linkage to care.
  36. 36. Is there more money now?  Not yet.  But you can use existing funds.  You will be more competitive for future funds.  There may be additional funding in the future.  There may be funding opportunities of which you are not yet aware right now.
  37. 37. Sustainability
  38. 38. Diversification of funding streams  Because of ACA and depending on your state’s Medicaid program, you may be able to bill for the following:  Preventive health screening, behavioral health screening (EtOH, SBIRT), case management, medical interpretation, naloxone, medication-assisted treatment (suboxone).  Please provide one-stop shopping!
  39. 39. What do SEPs look like?  Arranged delivery  Mobile unit  Stationary site  Sometimes the community provides for itself. Other times it invites county health or local service providers to come in.
  40. 40. Don’t Forget:  Health department  AIDS service organizations  Current SEPs  You may want to provide your own services, but this way you can provide services NOW and gather data to justify future funding.
  41. 41. Legal environment  Federal Land.  Area with law specifically enabling SEP.  Area with no legal opinion.  Area with law specifically prohibiting SEP.
  42. 42. Laws in OK and KS  Standard drug paraphernalia laws: intent determines legality of syringe.  Options: eliminate syringes in the list of paraphernalia, “tell officer law”, exception for syringe exchange participant (ID card).  Physician Prescription of Sterile Injection Equipment  Reasonable Claim to Legality: OK  Clearly illegal: KS  Pharmacy Sale of Prescribed Syringes  Reasonable Claim to Legality: OK  Clearly illegal: KS  Naloxone law in OK is exceptionally progressive.
  43. 43. Legal work-arounds  Utah  North Carolina  Long Island
  44. 44. Law enforcement support  Webinar: webinar-strategies-on-expanding-harm- reduction-through-law-enforcement/  Slides: content/uploads/2016/01/Law-Enforcement-and- Harm-Reduction-Webinar-Slides.pdf  List of resources: content/uploads/2016/01/Resources-on-Law- Enforcement-Syringe-Service-Programs.pdf
  45. 45. If you build it, will they come?
  46. 46. What did we see when people came?
  47. 47. What do wound care kits look like?  Document the problem (also provides baseline data)  Wound care kits (as pictured, but with antibiotic ointment, gauze, and one-pager instead of bleach and bottle).  Utilization review of the components of the wound care kits.  Bake sale/bottled water drive.
  48. 48. Community health is like that movie about baseball.
  49. 49. Additional considerations  One-for-one vs. needs- based exchange.  Secondary exchanges.  Counting-out syringes returned.
  50. 50. Plan of action  Visit NASEN website to see if there is already someone doing this work in your area.  Sign-up for the harmred listserv.  Sign-up for the NNAAPC working group.  Inform your GPOs at HRSA, SAMHSA, CDC, and IHS of your interest.  Reach out to local law enforcement.
  51. 51. Learn from those who went before you
  52. 52. An expert: Is someone who has made every possible mistake in a given situation
  53. 53. Your new best friends  NASEN (North American Syringe Exchange Network):  Directory of SSPs with contact info, Dave Purchase Memorial National Survey, ordering info.  Harm Reduction Forum listserv:  The most efficient way to find out the latest and ask for help.  Washington Heights Corner Project:  Program policies and procedures, curricula, marketing materials.  Tribal Syringe Exchange Outreach Project:  Alex White Tail Feather, Executive Director, NNAAPC,
  54. 54. Websites worth perusing*  Harm Reduction Coalition:  North Carolina Harm Reduction Coalition:  Chicago Recovery Alliance:  Prescribe to prevent (for prescribers and pharmacists):  *And I’ll be providing a list of Native American-specific resources.
  55. 55. QUESTIONS????
  56. 56. Thank you! Mary Beth Levin, MPH Associate Professor Department of Family Medicine Georgetown University School of Medicine