pharmaceutical stewardship in the u.s.

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1 pharmaceutical stewardship in the u.s. drug take-back challenges and successes nacwa pretreatment workshop pharms take back session may 17, 2018 scott cassel

2 who is the product stewardship institute? 2

3 our goal reduce the health & environmental impacts of products across their lifecycle 3

4 product stewardship vs. EPR product stewardship manufacturer ( producer ) responsibility other government regulatory programs voluntary programs mandatory programs (e.g., EPR) 4

5 product categories batteries packaging pharmaceuticals HHW medical sharps paint Mattresses thermostats phone books electronics fluorescent lamps Textiles and more 5

6 product categories appliances with refrigerants gas cylinders pesticides framework carpet auto switches tires radioactive devices solar panels 6

7 Products like: Paint Pesticides Used motor oil Household hazardous waste can all end up down the drain. 7

8 pharmaceuticals the problem 8

9 aquatic impacts water quality environmental health 9

10 drug abuse accidental poisonings health & safety 10

11 the solution 11

12 drug take back approaches and funding sources voluntary programs government funded programs retail pharmacy initiatives law enforcement initiatives legislation laws requiring program funding from pharmaceutical industry with government oversight 12

13 drug take back programs on site receptacles mail back envelopes collection events 13

14 challenges 14

15 regulatory barriers at the state and federal levels sustainable funding for drug take back pharma industry opposition to EPR laws 15

16 successes and status today 16

17 key events in drug stewardship psi identified the problem & need for a national solution 2008 federal secure and responsible drug disposal act passes dea s final rule on the collection of controlled substances comes out psi s briefing 2010 document + stakeholder dialogue meetings 2015 alameda county supreme court case = Extended producer responsibility (EPR) law passed 17

18 what does the dea rule allow? flexibility in collection of controlled substances mail back programs by dea authorized entities take back events by law enforcement agencies continue addition of pharmacies as authorized collection sites increase in potential collectors leads to additional permanent collection sites 18

19 US support for drug take back drug enforcement administration (DEA) o eleven national prescription drug take back days office of national drug control policy (ONDCP) o part of its national drug control strategy food and drug administration (FDA) o developed guidelines with ONDCP for drug disposal environmental protection agency (EPA) o promotes consumer use of take back programs states o the majority of state agency websites provide information either on their own state programs and/or federal DEA take back days 19

20 state and local EPR laws around the nation: state, 22 local 113 * EPR laws *while bottle bills are highly effective at recovering beverage containers, this count does not include the 10 state bottle bills in the U.S. due to the different ways in which the disparate policies shift responsibility to producers. 20

21 pharmaceuticals EPR in the united states 25 EPR laws today: 3 states (ma, vt, wa) 18 counties (ca, wa, il, ny) 4 cities legislative activity at local, state, & federal levels 21

22 22

23 pharmaceuticals EPR programs in canada and europe france established in 1993 british columbia established in 1996 canada: 4 programs europe: 15 programs manitoba established in 2011 hungary established in 2005 portugal established in 2001 spain established in 2003 Source: Health Products Stewardship Association, 2015; Health Care Without Harm Report,

24 drug take-back program examples 24

25 usda funded pilots in rural ny psi drug take back pilots 2016: 4 independent retail pharmacies + 1 hospital pharmacy 2018: 5 hospital pharmacies collection receptacles + mail back envelopes community outreach/education resources developed: how to guide educational toolkit for medical professionals 2017 oklahoma deq pilot at 5 independent retail pharmacies across state pharmacy receptacles community outreach/education 25

26 drug take back resources 26

27 psi resources 27

28 membership/partnership consulting pilot projects legislative support voluntary programs webinars more psi services contact vivian fuhrman for more information on our drug/medical sharps disposal work: 28

29 For more information and to register, visit: productstewardship.us/webinars 29

30 Global Best Practices for Drug Take-Back Programs June 7, am 12:30 pm EDT / 5 pm 6:30 pm CEST Pricing: FREE! Thanks to our sponsor: questions? megan@productstewardship.us (617) expert speakers include: register now Thierry Moreau Defarges (France) President Cyclamed Therese Hansen (Sweden) Quality + Environment Coordinator Apoteket Vivian Fuhrman (United States) Senior Assoc. Policy + Programs Product Stewardship Inst. Ginette Vanasse (Canada) Director General Health Products Stewardship Assoc. Robert Svanström (Sweden) Managing Pharmacist Swedish Pharmacy Assoc. 30

31 questions? 31

32 thank you! scott cassel ceo + founder scott@productstewardship.us 32

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