Pharmaceuticals - Product Stewardship Institute

August 2, 2018 | Author: Anonymous | Category: N/A
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Left-Over Household Pharmaceuticals: A Government Perspective

Dave Galvin Local Hazardous Waste Management Program in King County (Seattle, WA) June 19, 2008

A reflection of concern…

Pharmaceuticals • Wide range of biologically-active chemicals • 5-10% designate as hazardous waste • A different 5-10% are Controlled Substances -- challenging to manage

Pharmaceuticals (cont’d) • Controlled Substances – regulated by the Federal Drug Enforcement Administration due to potential for abuse – Schedule I – illegal drugs (ex., heroin, LSD) – Schedule II – morphine, OxyContin, codeine, Demerol, Ritalin, amphetamines, fentanyl – Schedule III – Tylenol with codeine, Vicodin – Schedule IV – benzodiazepines, Valium, Darvon, phenobarbital – Schedule V – codeine cough syrups

Some Pharmaceuticals are Endocrine Disrupting Chemicals

Drugs are showing up in the environment • Ibuprofen, valium, prozac, antibiotics, steroids, hormones • Found in 80% of U.S. streams tested by USGS • Found in drinking water supplies in many U.S. cities

Drugs in the environment (cont’d) • Antibiotics, hormones, SSRIs are receiving the most attention. • Boulder Creek, CO, study: 50:50 female:male ratio upstream, 90:10 downstream; ethynylestradiol measurably higher downstream. • Male fish are producing eggs in many places.

Drugs in the environment (cont’d) • Bioassays of SSRIs are showing some sub-lethal effects at environmentallyrelevant levels. Clean water

50 ppb fluoxetine

• 2006 Italian study found that a mixture of common drugs at very low (ng/L environmentally-relevant) concentrations inhibited the growth of human embryonic cells

Drugs enter the environment through use and disposal • Probably most result from use, passing through us un-metabolized, then going through wastewater treatment systems • Unused/unwanted quantities could be huge, as much as 50% of many prescriptions (80% for antibiotics) • Common/historical recommendation was to flush; “crush&flush” is still widely practiced method

Too Many Drugs Go Unused • PhRMA uses an estimate of 3% of all meds go unused • British survey showed: – 82% of antibiotics go unused – 50% of antidepressants “ – 50% of beta-blockers “ – 20% of pain meds “ [Ref: Bound & Voulvoulis, 2005]

• Austria & Germany – 25-33% go unused [Source: Kummerer, K., 2004]

Unused Accumulations (cont’d) • Compliance/adherence rates for some medications are under 20% • Patient compliance goes down as # of medications goes up: “polypharmacy” • Medicare Part D now requires 30-day supply billings, regardless of need and without ability to refund unused expenses (or to return unused product)

Unused Accumulations (cont’d) • Hospice nurses, nursing homes and medical examiners are faced with large accumulations of medicines, including potent controlled substances, when patients die • “Catch 22” for handling the left-overs – no easy, safe, legal or environmentally acceptable answers

Drug sales have skyrocketed U.S. sales have more than doubled in last 5 yrs

(Ref: National Drug Intelligence Center, 2005, via Ilene Ruhoy, 2006)

Increased Sales = More Exposure • From 1993 to 2003 the US population increased 13% – prescriptions purchased increased 70% – prescriptions/capita increased 7.8 to 11.8. [Source: Kaiser Family Foundation, October 2004]

Increased Sales (cont’d) Prescription Opiates Sold in King County Percent Change 1997-2003

Source- ARCOS/DEA Data for Zip Codes 980xx and 981xx, which approximates King County boundaries

Poisonings • Of all calls to U.S. poison control centers in 2004: – 2,438,644 total exposures reported – 1,389,156 (57%) were pharmaceutical exposures – 581,488 (42%) of the pharm exposures were to children under 6 years of age

Poisonings (cont’d)

Diversion & Abuse • Between 1992 and 2003: – # of teens (12 to 17 yrs of age) who abused controlled drugs jumped 212% – One in five teens says he or she has been offered prescription drugs to get high – # of all Americans who abuse controlled prescription drugs nearly doubled, from 7.8 million to 15.1 million (Ref: CASA, 2005)

Diversion & Abuse (cont’d) • Increasing popularity of prescription narcotics over Schedule I drugs (perceived to be “safer”) • Most teens get their prescription drugs from home or friends • OxyContin street value now = $80 per pill

Drug Abuse (cont’d) Drug Involved Deaths, King County Rx

Trash (MSW) is not the option • White House Office of Drug Control Policy says mix with coffee grounds and throw in the trash • Not secure: still available to children, pets, homeless, solid waste workers • Landfills (80% of U.S. solid waste) still produce liquid leachate, which often goes to municipal wastewater plants

Unfunded mandate • Problem wastes should not be the responsibility of local government and local tax-/rate-payers • A product stewardship approach is needed

Summary of Concerns • • • • • •

Lots of unused drugs in people’s homes Poisoning and abuse concerns Low compliance = high accumulations Left-overs are routinely flushed Drugs are showing up in the environment No safe, legal, environmentally-acceptable options exist • Local governments should not have to foot the bill

Dave Galvin Local Hazardous Waste Management Program in King County, Seattle, WA [email protected]

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