Stewardship Plan Evaluation

Transcription

1 Stewardship Plan Evaluation STEWARDSHIP ORGANIZATION: STATUS DATE: MAY 13, 2015 KING COUNTY MED-PROJECT, LLC TH STREET, SUITE 500 PLAN APPROVAL STATUS: PLAN REJECTED WASHINGTON, DC STATUS REQUESTED: STANDARD PLAN STEWARDSHIP PLAN NOTIFIED: MAY 13, 2015 STEWARDSHIP PLAN RECEIVED: FEBRUARY 12, 2015 Requirements of the Regulations (King County Board of Health Chapter 11.50) A. Evaluation: B. King County Secure Medicine Return Regulations Stewardship Plan Evaluation - King County MED-Project, LLC Page 1 of 11 Status Contact information for all drug producers participating in the stewardship plan. Partial contact information is provided, including business name and address for each participating drug producer. Provide additional contact information for all drug producers participating in the stewardship plan including contact name, contact title, phone number and/or address for each business name and address provided. A description of the proposed collection system to provide ongoing collection service for all unwanted covered drugs from covered entities in compliance with the provisions and requirements in BOH , including a list of all collection methods and participating collectors, a list of drop-off locations, a description of how periodic collection events will be scheduled and located if applicable, a description of how mail-back services will be provided and an example of the prepaid-preaddressed mailers to be utilized. The description shall include a list of retail pharmacies and law enforcement agencies contacted by the plan under BOH D.2.and a list of collectors who offered to participate. Evaluation: 1. A description of the proposed collection system is provided including: a. A description of the three required collections methods (drop-off sites, events, and mailback). b. A list of proposed collectors the plan intends to work with. c. A list of proposed drop-off locations the plan intends to work with. d. A description of how periodic collection events will be scheduled and located. e. A description of how mail-back services will be provided. f. A list of pharmacies and law enforcement agencies that expressed their interest in participating in the plan as a collector directly to the stewardship organization. g. A list of retail pharmacies and law enforcement agencies contacted by the plan under BOH D.2. h. information is provided in this evaluation for BOH requirements under additional sections relating to BOH The description of the proposed collection system is lacking: a. A list of confirmed collectors who have offered to participate. b. A list of confirmed drop-off locations associated with the collectors who have offered to participate. c. A sufficient number of proposed collection sites that meet the requirements of the service convenience standards. d. Periodic collection events providing ongoing collection for all covered entities that meets the service convenience standards. e. A proposed collection system that includes pharmacy drop-off locations. f. A description of mail-back services that includes: i. An example of the prepaid-preaddressed mailers that will be utilized ii. Distribution of mailers by service providers to differentially-abled and home bound residents. iii. Mail-back services that collect all covered drugs, including controlled substances, and disposal method. 3. Evaluation of the stewardship plan is based on a list of confirmed participating collectors. a. Approval of proposed collectors and associated drop-off locations identified by the stewardship plan for 30 law enforcement agencies is pending confirmation of law enforcement agency participation. b. Approval of collectors and associated drop-off locations is pending confirmation of participation by the pharmacies and law enforcement offices that have expressed interest directly to the stewardship plan. All pharmacies and law enforcement offices providing their interest in participating as a collector in the stewardship plan must be provided the opportunity in accordance with Secure Medicine Return Regulations. 4. The phased approach included in the proposed collection system does not meet the requirements of the service convenience standards as required under the regulations. The minimum number of drop-off locations required for each city, town and unincorporated community service area will be operational no later than 90 days of plan approval as required under the regulations. For each city, town and unincorporated community service area where it is not possible to provide the required number of drop-off locations, in the interim, a series of collection events established no later than 90 days of plan approval will meet the service convenience standards until a sufficient number of permanent drop-off locations are available in each city, town and unincorporated community service area. 5. The phased approach included in the proposed collection system does not provide for the collection of covered drugs, including controlled substances, by pharmacy drop-off locations. As described by the proposed stewardship plan under medium and long-term goals in years two and three, the stewardship plan states the King County MED-Project is not eligible to be a DEA registered collector of controlled substances and will explore how it can support an expanded program. a. It is not a requirement of the Secure Medicine Return Regulations for the stewardship organization to become a DEA-registered collector of controlled substances. b. Under the United States Drug Enforcement Administration (DEA) final rule adopted in

2 C. September 2014, a pharmacy can collect covered drugs, including controlled substances, as an authorized collector in accordance with the DEA requirements. 6. Proposed mail-back services do not include distribution of mailers by service providers to differentially-abled and home bound residents. 1. Provide a description of how covered drugs, including controlled substances, will be collected using collection events when the required number of drop-off locations are limited or not available to meet the service convenience standards within 90 days of plan approval. Description will include how interim collection will meet the service convenience requirements of one drop-off location for every 30,000 residents for each city, town and unincorporated community service area, dates and locations for on-going collection. 2. Provide a description of a sufficient number of drop-off locations that meet service convenience standards for ongoing collection. 3. Provide a description of a proposed collection system that includes pharmacy drop-off locations including: a. Documentation for each participating pharmacy verifying it is an authorized collector in accordance with DEA requirements. b. Documentation for each participating pharmacy verifying it is approved to operate as a collection site by the Washington State Pharmacy Quality Assurance Commission (WSPQAC). 4. Provide a list of collectors who are confirmed participants in the stewardship plan. 5. Provide a list of confirmed drop-off locations that includes: a. Law enforcement agencies that were submitted as proposed collection sites. b. Pharmacies and law enforcement agencies that provided their interest in participating as a collector directly to the stewardship plan. 6. Provide a description of mail-back services that collects all covered drugs, including controlled substances, including: a. A description of the disposal method. b. A description for distribution of mailers by service providers to differentially-abled and home bound residents. c. An example of the prepaid-preaddressed mailers that will be utilized. A description of the handling and disposal system, including identification of and contact information for collectors, transporters and waste disposal facilities to be used by the stewardship plan in accordance with BOH and Evaluation: 1. A description of the handling and disposal system is provided including: a. Identification and contact information for the transporter to be used by the stewardship plan. b. Identification and contact information for the waste disposal facility to be used by the stewardship plan in accordance with BOH and c. General statements that it will comply with all local, state and federal regulatory requirements. d. Operational procedures, including training, are the responsibility of the collection site. e. Identification of the collection vendor as the responsible party for compliance with all legal requirements. 2. The description of the handling and disposal system is lacking: a. A list of confirmed collectors who have offered to participate. b. A list of confirmed drop-off locations. c. Description of a proposed collection system that includes pharmacy drop-off locations. i. Approval of collectors providing a pharmacy drop-off location is conditional pending verification each location is compliant with DEA and WSPQAC regulations. d. A description of mail-back services that includes: i. An example of the prepaid-preaddressed mailers that will be utilized ii. Distribution of mailers by service providers to differentially-abled and home bound residents. iii. Mail-back services that collect all covered drugs, including controlled substances, and disposal method. 3. Evaluation of the stewardship plan is based on a list of confirmed participating collectors and drop-off locations. All pharmacies and law enforcement offices providing their interest in participating as a collector in the stewardship plan must be provided the opportunity in accordance with Secure Medicine Return Regulations. a. Approval is pending confirmation of the proposed collectors identified by the stewardship plan for 30 law enforcement agencies. b. Approval is pending confirmation of the proposed drop-off locations identified by the stewardship plan for 30 law enforcement agencies. c. Approval is pending confirmation of the pharmacies and law enforcement offices that have expressed interest directly to the stewardship plan in participating as a collector. 1. Provide a list of confirmed collectors who have offered to participate including business name, address, contact name, phone number and/or address. 2. Provide a list of confirmed drop-off locations including business name, address, contact name, phone number and/or address. 3. Provide documentation for each participating pharmacy verifying it is an authorized collector in accordance with DEA requirements. 4. Provide documentation for each participating pharmacy verifying it is approved to operate as a collection site by the WSPQAC. 5. Provide a description of mail-back services that includes: a. An example of the prepaid-preaddressed mailers that will be utilized b. Distribution of mailers by service providers to differentially-abled and home bound residents. c. Mail-back services that collect all covered drugs, including controlled substances, and disposal method. 6. Provide additional information for the permitted hazardous waste disposal facility identified verifying the proposed waste incinerator meets all requirements for disposal under 40 C.F.R. parts 264 and 265. King County Secure Medicine Return Regulations Stewardship Plan Evaluation - King County MED-Project, LLC Page 2 of 11

3 D. A description of the policies and procedures to be followed by persons handling unwanted covered drugs collected under the stewardship plan, including a description of how all collectors, transporters and waste disposal facilities utilized will ensure the collected, unwanted covered drugs are safely and securely tracked from collection through final disposal, and how all entities participating in the stewardship plan will operate under all applicable federal and state laws, rules and guidelines, including those under applicable rules and guidelines of the state of Washington Board of Pharmacy Evaluation: 1. A description of policies and procedures for handling unwanted covered drugs collected under the stewardship plan is provided including: a. General statements that it will comply with all local, state and federal regulatory requirements b. Operational procedures, including training, are the responsibility of the collection site with training from the Collection Vendor subject to an acceptable agreement with the Collection Site. c. Identification of the collection vendor as the responsible party for compliance with all legal requirements. d. Training and maintenance schedule for kiosk Service Technicians. e. Collection Vendor procedures for pick-up and disposal of collected covered drugs. f. Collection receptacles (kiosks) to be placed at proposed law enforcement agency sites. 2. The description of policies and procedures for handling unwanted covered drugs collected under the stewardship plan is lacking: a. A description of a proposed collection system that includes pharmacy drop-off locations. b. Documentation for each participating pharmacy verifying it is an authorized collector in accordance with DEA and approved to operate as a collector by WSPQAC. c. A description of mail-back services that collect all covered drugs, including controlled substances, including information for mail-back envelopes that will be used meeting DEA requirements, the disposal method and the waste disposal facility the stewardship plan will use. d. A description for modifying an existing DEA registration to be designated as a collector. e. A description of specific exiting DEA registrants that can be authorized to serve as a collector. f. A description of DEA restrictions that only allow collectors to accept Schedule II-V controlled substances. g. A description of DEA restrictions that does not allow collectors to dispose of inventory or stock in collection receptacles or mail-back envelopes. h. A description of DEA restrictions for handling controlled substances returned by ultimate users. i. A description of DEA requirements for secure storage by authorized collectors. j. A description of DEA requirements for transfer of drugs for final disposal by practitioner collectors. k. A description of DEA requirements for record-keeping for all collectors. l. A description of DEA requirements for oversight of proposed kiosks at law enforcement sites. m. A description of DEA requirements for oversight by a law enforcement officer at takeback events and mail-back programs provided by law enforcement. n. A description of DEA requirements for law enforcement and handling controlled substances at take-back events. o. A description of DEA requirements for specification of mail-back envelopes used to collect all covered drugs, including controlled substances. p. A description of DEA requirements that does not require personal information from ultimate user. q. A description of DEA requirements for handling mail-back envelopes for collectors administering a mail-back program. r. A description of DEA requirements for kiosk design with small opening that is baffled or otherwise constructed so contents cannot be removed. s. A description of DEA requirements for signage on kiosk that indicates only Schedule II-V controlled substances and non-controlled substances are accepted. t. A description of DEA requirements for a kiosk inner liner with a permanent identification number for tracking that is unique to each collector. u. A description for DEA requirements for a kiosk inner liner that is immediately sealed and cannot be opened, x-rayed, analyzed or otherwise penetrated. v. A description for DEA allowance of controlled and non-controlled substances that can be comingled during collection. w. A description for DEA requirements for counting or inventorying, or opening of sealed inner liners. x. A description for DEA allowance of visual screening of covered drugs prior to placement in a kiosk. Provide the following information: 1. A description of a proposed collection system that includes pharmacy drop-off locations. 2. Documentation for each participating pharmacy verifying it is an authorized collector in accordance with DEA and approved to operate as a collector by WSPQAC. 3. A description of mail-back services that collect all covered drugs, including controlled substances, including information for mail-back envelopes that will be used meeting DEA requirements, the disposal method and the waste disposal facility the stewardship plan will use. 4. A description for modifying an existing DEA registration to be designated as a collector. 5. A description of specific exiting DEA registrants that can be authorized to serve as a collector. 6. A description of DEA restrictions that only allow collectors to accept Schedule II-V controlled substances. 7. A description of DEA restrictions that does not allow collectors to dispose of inventory or stock in collection receptacles or mail-back envelopes. 8. A description of DEA restrictions for handling controlled substances returned by ultimate users. 9. A description of DEA requirements for secure storage by authorized collectors. 10. A description of DEA requirements for transfer of drugs for final disposal by practitioner collectors. 11. A description of DEA requirements for record-keeping for all collectors. 12. A description of DEA requirements for oversight of proposed kiosks at law enforcement sites. King County Secure Medicine Return Regulations Stewardship Plan Evaluation - King County MED-Project, LLC Page 3 of 11

4 E. 13. A description of DEA requirements for oversight by a law enforcement officer at take-back events and mail-back programs provided by law enforcement. 14. A description of DEA requirements for law enforcement and handling controlled substances at take-back events. 15. A description of DEA requirements for specification of mail-back envelopes used to collect all covered drugs, including controlled substances. 16. A description of DEA requirements that does not require personal information from ultimate user. 17. A description of DEA requirements for handling mail-back envelopes for collectors administering a mail-back program. 18. A description of DEA requirements for kiosk design with small opening that is baffled or otherwise constructed so contents cannot be removed. 19. A description of DEA requirements for signage on kiosk that indicates only Schedule II-V controlled substances and non-controlled substances are accepted. 20. A description of DEA requirements for a kiosk inner liner with a permanent identification number for tracking that is unique to each collector. 21. A description for DEA requirements for a kiosk inner liner that is immediately sealed and cannot be opened, x-rayed, analyzed or otherwise penetrated. 22. A description for DEA allowance of controlled and non-controlled substances that can be comingled during collection. 23. A description for DEA requirements for counting or inventorying, or opening of sealed inner liners. 24. A description for DEA allowance of visual screening of covered drugs prior to placement in a kiosk. A description of how patient information on drug packaging will be kept secure during: collection; transportation; and recycling or disposal Evaluation: Required information is provided meeting the requirements of the regulations. Complete F. None. A description of the public education effort and promotion strategy required in BOH of this rule, including a copy of standardized instructions for residents, signage developed for collectors and required promotional materials Evaluation: 1. A description of consumer promotion and education is provided including: a. Website available for consumer education, collection options and drop-off location information. b. Toll-free number is available for education materials, mail-back envelopes, safe storage and handling and drop-off location information. Callers will have the option of hearing messages in English or Spanish. c. Toolkit for community and government organizations and other stakeholders to promote program. d. Public services announcement to promote stewardship plan. e. Messaging that promotes safe storage by residents. f. Example education and outreach materials with messaging for drop-off locations and how to return unwanted covered drugs. g. Description of coordinated promotional activities so residents can easily identify and understand collection services by any stewardship plan. h. Example collection box signage and consumer instructions. 2. The description of consumer promotion and education provided is lacking: a. Call script does not provide convenient or informative messaging for residents to b. Messaging with a primarily focus on educating residents to use drop-off locations that is c. Example of plain language and explanatory images that promotes consumer education and use of drop-off locations for residents with limited English proficiency. d. Distribution of materials to include retail pharmacy, law enforcement, health care providers, visiting nurses associations, local government agencies and other providers. 3. A description of proposed drop-box design includes: a. Unique design of new drop-boxes that is readily recognizable. b. Proposed use of existing drop boxes currently in place at temporary voluntary take-back locations c. Description of proposed use of existing drop boxes currently in place at temporary voluntary take-back locations is inconsistent with the requirement for providing readily recognizable and consistent design of drop-boxes. 1. Provide an example call script with convenient and informative messaging for residents to 2. Provide messaging with a primarily focus on educating residents to use drop-off locations that is 3. Provide an example of plain language and explanatory images that promotes consumer education and use of drop-off locations for residents with limited English proficiency. 4. Provide a description of distribution of materials to include retail pharmacy, law enforcement, health care providers, visiting nurses associations, local government agencies and other providers. 5. Provide information for proposed use of existing drop-boxes currently in place at temporary voluntary take-back locations that is consistent with newly located drop-off sites that is a readily recognizable and consistent drop-box design G. A proposal on the short-term and long-term goals of the stewardship plan for collection amounts, education and promotion Evaluation: 1. A description of short-term collection goals is provided including: a. The approximate number of collection locations in year one is 30 drop-off sites at law enforcement locations and one take-back collection event. b. One take-back event will be scheduled and will be supervised by a Law Enforcement Agency. 2. The description of short-term collection goals is lacking: King County Secure Medicine Return Regulations Stewardship Plan Evaluation - King County MED-Project, LLC Page 4 of 11

5 a. Confirmed number of collection locations meeting the service convenience goals. b. A description for collection of all covered drugs, including controlled substances, by pharmacies interested in participating in the stewardship plan as a collector. c. A description of the collection totals anticipated for the first year. d. Collection totals anticipated within the first 90 days. e. Date and location of take-back event. 3. A description of short-term education and promotion goals is provided including: a. Metrics that will be developed to evaluate education and promotion i. Develop baseline number of website page views or unique visitors. ii. Develop baseline number of law enforcement agencies, community groups, pharmacies and other third parties contacted. iii. Number of media outlets receiving press advisory iv. Percent County community center reached v. Number of messages to King County MED-Project returned within predetermined timeframe. 4. The description of short-term education and promotion goals is lacking: a. Goals for all education and promotion based on metrics provided. 5. A description of regulatory outreach goals is provided including: a. Contacting members of the classes of potential collector entities identified and invite them to participate in the plan. b. Set targets based on identities of classes of collectors. 6. The description of regulatory outreach goals is lacking: a. A description of the classes of potential collector entities identified and template agreement. 7. A description of long-term collection goals is provided including: a. Expanded law enforcement agency locations according to required geographical distribution within the county. b. King County MED-Project will explore how it can support an expanded program for collection sites if not eligible to be a DEA-registered collector of controlled substances. c. One annual take-back event. 8. The description of long-term collection goals is lacking: a. Confirmed number of collection locations meeting the service convenience goals. b. A description for collection of all covered drugs, including controlled substances, by pharmacies interested in participating in the stewardship plan as a collector. c. A description of the collection totals anticipated. d. Date and location of take-back event(s). 9. A description of long-term education and outreach goals is provided including: a. Ongoing plan to revise and/or add communications materials based on changes to the plan. b. Annually evaluate media and public outreach and feedback from community groups to make adjustments and improvements to stewardship plan strategy and tactics. c. Review will measure percent awareness of the stewardship plan, assess whether collection methods are convenient and easy to use, assess knowledge and attitudes about risks of abuse, poisonings and overdoses from prescription and nonprescription medicines used in the home. d. Results of the review will be published on the King County MED-Project website. 10. The description of long-term education and outreach goals is lacking: a. Criteria, method and analysis that will be used to evaluate and report results for evaluating media, public outreach and feedback received from community groups. b. Scope of adjustments and improvements anticipated. c. Criteria, method and analysis that will be used to review and measure percent awareness of the stewardship plan, assess whether collection methods are convenient and easy to use, assess knowledge and attitudes about risks of abuse, poisonings and overdoses from prescription and nonprescription medicines used in the home. 1. Provide a description of short-term collection goals for the confirmed number of collection locations meeting the service convenience standards. 2. Provide a description for collection of all covered drugs, including controlled substances, by pharmacies interested in participating in the stewardship plan as a collector. 3. Provide a description of the collection totals anticipated for the first year. 4. Provide collection totals anticipated within the first 90 days. 5. Provide date and location of take-back event(s). 6. Provide a description of short-term goals for all education and promotion based on metrics provided. 7. Provide a description of short-term regulatory outreach goals for the classes of potential collector entities identified and template agreement. 8. Provide a description of long-term collection goals for the confirmed number of collection locations meeting the service convenience goals. 9. Provide a description of long-term collection for the collection of all covered drugs, including controlled substances, by pharmacies interested in participating in the stewardship plan as a collector. 10. Provide a description of long-term collection goals for the collection totals anticipated. 11. Provide a description of long-term collection goals for the take-back event(s), including date(s) and location(s). 12. Provide a description of the criteria, method and analysis that will be used to evaluate and report results for evaluating media, public outreach and feedback received from community groups for long-term education and outreach goals. 13. Provide a description of scope of adjustments and improvements anticipated as part of long-term education and outreach goals. 14. Provide criteria, method and analysis that will be used to review and measure percent awareness of the stewardship plan, assess whether collection methods are convenient and easy to use, assess knowledge and attitudes about risks of abuse, poisonings and overdoses from prescription and nonprescription medicines used in the home as part of long-term education and outreach goals King County Secure Medicine Return Regulations Stewardship Plan Evaluation - King County MED-Project, LLC Page 5 of 11

6 H.1. A description of how the stewardship plan will consider use of existing providers of waste pharmaceutical services. Evaluation: Required information is provided meeting the requirements of the regulations. Complete None H.2. A description of how the stewardship plan will consider separating covered drugs from packaging to the extent possible to reduce transportation and disposal costs. Evaluation: 1. A description of how the stewardship plan will consider recycling of drug packaging to the extent possible to reduce transportation and disposal costs is not provided. 1. Provide a description of how the stewardship plan will consider recycling of drug packing H.3. A description of how the stewardship plan will consider recycling of drug packaging to the extent feasible. Evaluation: 1. A description of how the stewardship plan will consider recycling of drug packaging to the extent feasible is not provided. 1. Provide a description of how the stewardship plan will consider recycling of drug packing A. This chapter does not require any person to serve as a collector in a stewardship plan. A person may offer to serve as a collector voluntarily, or may agree to serve as a collector in exchange for incentives or payment offered by a producer, group pf producers or stewardship organization. Collectors may include law enforcement, pharmacies, mail-back services or other entities, operating in accordance with state and federal laws and regulations for the handling of covered drugs, including those of the United States Drug Enforcement Administration, and in compliance with this chapter. A pharmacy collection site will operate under applicable rules and guidelines of the state of Washington Board of Pharmacy (aka Pharmacy Quality Assurance Commission). Evaluation: 1. A description of collector information provided includes: a. Description of proposed collection sites that include 30 of the 50 available law enforcement facilities in King County. b. Description of mail-back services provided for differentially-abled and home bound residents through the stewardship plan s toll-free phone number and website. 2. The description of collector information is lacking: a. Description of mail-back services including distribution of mailers to differentially-abled and home bound residents by persons providing services to such residents. b. An example of the prepaid-preaddressed mailers that will be utilized. c. Description of a sufficient number of drop-off locations or combination of drop-off locations, mail-back services and take-back events that meet the service convenience standards and provide ongoing collection. d. List of confirmed collectors who have offered to participate. e. List of confirmed drop-off locations. f. Description of a proposed collection system that includes pharmacy drop-off locations. g. Description of process for documenting each participating pharmacy is an authorized collector in accordance with DEA and approved to operate as a collector by WSPQAC. 3. Evaluation of the stewardship plan is based on a list of confirmed participating collectors. a. Approval of proposed collectors and drop-off locations identified by the stewardship plan for 30 law enforcement agencies is pending confirmation of participation. b. Approval of collectors and drop-off locations is pending confirmation of participation by the pharmacies and law enforcement offices that have expressed interest directly to the stewardship plan. All pharmacies and law enforcement offices providing their interest in participating as a collector in the stewardship plan must be provided the opportunity in accordance with Secure Medicine Return Regulations. 4. The phased approach included in the proposed collection system does not meet the requirements of the service convenience standards as required under the regulations. The minimum number of drop-off locations required for each city, town and unincorporated community service area will be operational no later than 90 days of plan approval as required under the regulations. For each city, town and unincorporated community service area where it is not possible to provide the required number of drop-off locations, in the interim, a series of collection events established no later than 90 days of plan approval will meet the service convenience standards until a sufficient number of permanent drop-off locations are available in each city, town and unincorporated community service area. 5. The phased approach included in the proposed collection system does not provide for the collection of covered drugs, including controlled substances, by pharmacy drop-of locations. As described by the proposed stewardship plan under medium and long-term goals in years two and three, the King County MED-Project is not eligible to be a DEA registered collector of controlled substances. It is not a requirement of Secure Medicine Return Regulations for the stewardship organization to become a DEA-registered collector of controlled substances. Each pharmacy drop-off location can participate in the stewardship plan as an authorized collector in accordance with the DEA requirements. 1. Provide a description of how covered drugs, including controlled substances, will be collected using collection events when the required number of drop-off locations are not available to meet the service convenience standards within 90 days of plan approval. Description will include how interim collection will meet the service convenience requirements of one drop-off location for every 30,000 residents for each city, town and unincorporated community service area, dates and locations for on-going collection. 2. Provide a description of a sufficient number of drop-off locations or combination of drop-off locations, mail-back services and take-back events that meet service convenience standards for ongoing collection. 3. Provide a description of a proposed collection system that includes pharmacy drop-off locations that also includes: a. Documentation for each participating pharmacy verifying they are an authorized collector in accordance with DEA requirements and approved to operate as a collection site by the WSPQAC. 4. Provide a list of collectors who are confirmed participants in the stewardship plan and a confirmed list of drop-off locations that includes: a. Law enforcement agencies proposed as collection sites, including law enforcement King County Secure Medicine Return Regulations Stewardship Plan Evaluation - King County MED-Project, LLC Page 6 of 11

7 B. agency name, address, contact name, phone number and/or address. b. Pharmacies and law enforcement agencies that provided their interest in participating as a collector directly to the stewardship, including business name, address, contact name, phone number and/or address. 5. Provide a description of mail-back services that collects all covered drugs, including controlled substances, that includes: a. Description for distribution of mailers by service providers to differentially-abled and home bound residents. b. An example of the prepaid-preaddressed mailers that will be utilized The collection system shall be convenient on an ongoing, year-round basis to adequately serve the needs of covered entities and shall be designed in consideration of equitable opportunities for all King County residents for the safe and convenient return of unwanted covered drugs, in accordance with this section Evaluation: 1. Ongoing collection is proposed for 22 of the 39 cities and towns in King County (56 percent). 2. Proposed collection for the cities of Burien, Issaquah, Kent, Renton, Sammamish, Auburn, Bellevue and Seattle do not provide a sufficient number of collection sites to meet the service convenience standards. 3. Proposed collection for the cities of Duvall, Enumclaw, Federal Way, Kirkland, Medina, Mercer Island, Newcastle, Pacific, Redmond, SeaTac, Shoreline, Tukwila, and Carnation is not provided. 4. Proposed collection for the towns of Beaux Arts Village, Hunts Point, Yarrow Point and Skykomish is not provided. 5. Proposed collection for the seven unincorporated community service areas is not provided (Bear Creek/Sammamish; Snoqualmie Valley/NE King County; Four Creeks/Tiger Mountain; Greater Maple Valley/Cedar River; SE King County; Vashon/Maury Island; West King County Areas). 6. Proposed collection does not include adequate collection providing equitable opportunities for cities and towns with the highest percentile of residents who are non-english speaking and who are living 200 percent below the Federal Poverty Level. 1. Provide a description of proposed collection in the cities of Burien, Issaquah, Kent, Renton, Sammamish, Auburn, Bellevue and Seattle that is sufficient in number to meet the service convenience standards. 2. Provide a description of proposed collection for the cities of Duvall, Enumclaw, Federal Way, Kirkland, Medina, Mercer Island, Newcastle, Pacific, Redmond, SeaTac, Shoreline, Tukwila, and Carnation. 3. Provide a description of proposed collection for the towns of Beaux Arts Village, Hunts Point, Yarrow Point and Skykomish. 4. Provide a description of proposed collection for the seven unincorporated community service areas is not provided (Bear Creek/Sammamish; Snoqualmie Valley/NE King County; Four Creeks/Tiger Mountain; Greater Maple Valley/Cedar River; SE King County; Vashon/Maury Island; West King County Areas). 5. Provide a description of proposed collection with adequate collection providing equitable opportunities for cities and towns with the highest percentile of residents who are non-english speaking and who are living 200 percent below the Federal Poverty Level C. The collection system for all unwanted covered drugs shall be safe and secure, including protection of patient information on drug packaging Evaluation: Required information is provided meeting the requirements of the regulations. Complete D.1. None. The service convenience goal for the standard stewardship plan and any independent stewardship plan is a system of drop-off sites distributed to provide reasonably convenient and equitable access for all residents in incorporated and unincorporated areas of the county. Evaluation: 1. Distribution of proposed collection sites is reasonably convenient and equitable for 14 of the 39 cities and towns in King County (36 percent). 2. Distribution of proposed collection in the cities of Burien, Issaquah, Kent, Renton, Sammamish, Auburn, Bellevue and Seattle is insufficient in number to provide reasonably convenient and equitable access for all residents.. 3. A description of proposed collection for the cities of Duvall, Enumclaw, Federal Way, Kirkland, Medina, Mercer Island, Newcastle, Pacific, Redmond, SeaTac, Shoreline, Tukwila, and Carnation is not provided and does not provide reasonably convenient and equitable access for all residents. 4. A description of proposed collection for the towns of Beaux Arts Village, Hunts Point, Yarrow Point and Skykomish is not provided and does not provide reasonably convenient and equitable access for all residents. 5. A description of proposed collection for the seven unincorporated community service areas is not provided and does not provide reasonably convenient and equitable access for all residents. (Bear Creek/Sammamish; Snoqualmie Valley/NE King County; Four Creeks/Tiger Mountain; Greater Maple Valley/Cedar River; SE King County; Vashon/Maury Island; West King County Areas). 6. Proposed collection does not include adequate collection providing equitable opportunities for cities and towns with the highest percentile of residents who are non-english speaking and who are living 200 percent below the Federal Poverty Level. 1. Provide a description of proposed collection in the cities of Burien, Issaquah, Kent, Renton, Sammamish, Auburn, Bellevue and Seattle that is sufficient in number to meet the service convenience standards and is reasonably convenient and equitable access for all residents. 2. Provide a description of proposed collection for the cities of Duvall, Enumclaw, Federal Way, Kirkland, Medina, Mercer Island, Newcastle, Pacific, Redmond, SeaTac, Shoreline, Tukwila, and Carnation to meet the service convenience standards and is reasonably convenient and equitable access for all residents. 3. Provide a description of proposed collection for the towns of Beaux Arts Village, Hunts Point, Yarrow Point and Skykomish to meet the service convenience standards and is reasonably convenient and equitable access for all residents.. 4. Provide a description of proposed collection for the seven unincorporated community service areas to meet the service convenience standards and is reasonably convenient and equitable access for all residents (Bear Creek/Sammamish; Snoqualmie Valley/NE King County; Four Creeks/Tiger Mountain; Greater Maple Valley/Cedar River; SE King County; Vashon/Maury King County Secure Medicine Return Regulations Stewardship Plan Evaluation - King County MED-Project, LLC Page 7 of 11

8 D.2. Island; West King County Areas). 5. Provide a description of proposed collection with adequate collection providing equitable opportunities for cities and towns with the highest percentile of residents who are non-english speaking and who are living 200 percent below the Federal Poverty Level. In establishing and operating a stewardship plan, a producer, group of producers or stewardship organization shall give preference to having retail pharmacies and law enforcement agencies serve as drop-off sites. A stewardship plan shall include, as collectors, any retail pharmacy or any law enforcement agency willing to voluntarily to serve as a drop-off site for unwanted covered drugs and able to meet the requirements of this chapter within three months of their offer to participate, unless the collector requests a longer time frame. A producer or group of producers establishing and operating a stewardship plan may also accept other collectors willing to serve as a drop-off site for unwanted covered drugs and able to meet the requirements of this chapter. Evaluation: 1. Plan provides a list of proposed collectors with a preference for law enforcement agencies. 2. Plan provides a list of seven pharmacies and three law enforcement agencies that expressed their interest in participating as a collection site directly to the stewardship plan is provided. 3. Plan does not provide a proposed collector list that includes the pharmacies and law enforcement agencies that expressed interest in participating as a collection site D Provide a list of collectors that includes the pharmacies and law enforcement agencies that expressed interest in participating as a collection site. All pharmacy and law enforcement offices who are interested in participating in the stewardship plan as a voluntary collector must be included. The system of drop-off sites shall provide in every city, town, or unincorporated community service area with a pharmacy or law enforcement facility, one drop-off site and a minimum of at least one additional drop-off site for every thirty thousand residents, geographically distributed to provide reasonably convenient and equitable access. Evaluation: 1. Proposed system of drop-off sites meet the minimum number of required collection locations in 14 of the 39 cities and towns in King County (36 percent). 2. A description of a system of drop-off sites at law enforcement facilities is geographically distributed providing reasonably convenient and equitable access in 14 of the 22 proposed collection locations (64 percent). 3. Proposed system of drop-off sites is lacking: a. A description of a sufficient number of collection sites to meet the service convenience standards in eight cities where a limited number of drop-off sites are provided. b. A description of proposed collection sites in thirteen cities and four towns where no dropoff sites are provided. c. A description of proposed collection sites for the seven unincorporated community services areas where no drop-off sites are provided. d. A description of proposed collection that provide reasonably convenient and equitable access for cities and towns with the highest percentile of residents who are non-english speaking and who are living 200 percent below the Federal Poverty Level. e. A description of mail-back services and collection events that will be used to meet the service convenience standards if collection sites are not available D Provide a description of proposed collection in the cities of Burien, Issaquah, Kent, Renton, Sammamish, Auburn, Bellevue and Seattle that is sufficient in number to meet the service convenience standards. 2. Provide a description of proposed collection for the cities of Duvall, Enumclaw, Federal Way, Kirkland, Medina, Mercer Island, Newcastle, Pacific, Redmond, SeaTac, Shoreline, Tukwila, and Carnation. 3. Provide a description of proposed collection for the towns of Beaux Arts Village, Hunts Point, Yarrow Point and Skykomish. 4. Provide a description of proposed collection for the seven unincorporated community service areas is not provided (Bear Creek/Sammamish; Snoqualmie Valley/NE King County; Four Creeks/Tiger Mountain; Greater Maple Valley/Cedar River; SE King County; Vashon/Maury Island; West King County Areas). 5. Provide a description of mail-back services and collection events that will be used to meet the service convenience standards if collection sites are not available. 6. Provide a description of proposed collection that provides reasonably convenient and equitable access for cities and towns with the highest percentile of residents who are non-english speaking and who are living 200 percent below the Federal Poverty Level. If the service convenience goal in D.3. of this subsection cannot be achieved by the standard stewardship plan or any independent stewardship plan due to a lack of drop-off sites at pharmacies, law enforcement agencies or other qualified collectors in specific areas of the county, then those areas shall be served through periodic collection events or mailback services, or a combination of these collection methods. Evaluation: 1. A description of a system of mail-back services and take-back events to be used when drop-off locations are not available is not provided E. 1. Provide a description of a system of mail-back services and take-back events that will be used when drop-off locations are not available that will collect all covered drugs, including controlled substances. 2. Provide a description of the anticipated take-back event(s) that includes date, location and law enforcement participation. Drop-off sites shall accept covered drugs from covered entities during all hours that the retail pharmacy, law enforcement agency, or other collector is normally open for business with the public. Drop off sites shall utilize secure drop boxes in compliance with all applicable requirements of the United States Drug Enforcement Administration and the state of Washington Board of Pharmacy (aka Pharmacy Quality Assurance Commission). Evaluation: 1. A description of available hours for drop-box accessibility is not provided. 2. General description of drop-box and drop-off site requirements in compliance with applicable federal, state and local laws and government regulations that is subject to the processes and procedures of the participating law enforcement agencies is provided including: a. Operational procedures, including training, are the responsibility of the collection site. b. Collection vendor is the responsible party for compliance with all legal requirements. 1. Provide a description of the available hours for drop-box accessibility. 2. Provide a description of how drop-boxes and drop-off sites are in compliance with all legal requirements and specific to DEA for law enforcement drop-off sites and for the DEA and WAPQAC for pharmacy drop-off sites. King County Secure Medicine Return Regulations Stewardship Plan Evaluation - King County MED-Project, LLC Page 8 of 11

9 F. Mail-back services shall be free of charge, and shall be made available to differentially-abled and home bound residents upon request through the stewardship plan s toll-free telephone number and web site, and through distribution of prepaid, preaddressed mailers to persons providing services to such residents, and may also be utilized as a collection method according to subsection D.4. of this section. Evaluation: 1. Mail-back services are offered free of charge to differentially-abled and homebound residents. 2. Mail-back envelopes are distributed by request through the stewardship plan toll-free telephone number and website 3. Mail-back services do not include distribution of prepaid, preaddressed mailers to persons providing services to residents. 4. Mail-back services do not include the use of mailers in underserved areas to meet convenience requirements G. 1. Provide information for method of distribution for prepaid, preaddressed mailers to differentiallyabled and home bound residents by persons providing services to residents. 2. Provide information for use of mail-back services in underserved areas to meet service convenience standards requirements. Periodic collection events, if utilized as a collection method according to subsection D.4. of this section, must be arranged with law enforcement personnel through voluntary agreements, and shall be conducted in compliance with United States Drug Enforcement Administration protocols, any additional requirements of participating law enforcement agencies, and in compliance with this chapter. Evaluation: 1. A description of an annual collection event is provided including: a. Event coordination with applicable King County offices, including law enforcement. b. Adequately staffed to provide effective monitoring of the event. c. Law enforcement present to provide security and review of collected materials. d. Containers will be securely packaged, labeled and shipped in compliance with applicable legal requirements. 2. The description of an annual collection event is lacking: a. A description of event operations, transportation and disposal consistent with all applicable local, state and federal regulations, including DEA requirements and protocols. b. A description of the trained personnel who will handle collected drugs during a collection event and how the handling process meets DEA protocols. c. A description of the agreements and requirements of participating law enforcement agencies. d. A description of take-back events provided to meet the service convenience standards A Provide a description of event operations, transportation and disposal consistent with all applicable local, state and federal regulations, including DEA requirements and protocols. 2. Provide a description of the trained personnel who will handle collected drugs during a collection event and how the handling process meets DEA protocols. 3. Provide a description of the agreements and requirements of participating law enforcement agencies. 4. Provide a description of take-back events provided to meet the service convenience standards. A producer or group of producers participating in the standard stewardship plan or an independent stewardship plan shall promote the use of their stewardship plan so that collection options for covered drugs are widely understood by residents, pharmacists, retailers of covered drugs and promote the safe storage of covered drugs by residents before secure disposal through their stewardship plan. Evaluation: 1. A description of consumer promotion and education is provided including: a. Website available for consumer education, collection options and drop-off location information. b. Toll-free number is available for education materials, mail-back envelopes, safe storage and handling and drop-off location information. Callers will have the option of hearing messages in English or Spanish. c. Toolkit for community and government organizations and other stakeholders to promote program. d. Public services announcement to promote stewardship plan. e. Messaging that promotes safe storage by residents. f. Example education and outreach materials with messaging for drop-off locations and how to return unwanted covered drugs. g. Description of coordinated promotional activities so residents can easily identify and understand collection services by any stewardship plan. h. Example collection box signage and consumer instructions. 2. The description of consumer promotion and education provided is lacking: a. A call script that provides convenient and informative messaging for residents to b. Messaging with a primarily focus on educating residents to use drop-off locations that is c. An example of plain language and explanatory images that promotes consumer education and use of drop-off locations for residents with limited English proficiency. d. A description of distribution of materials to include retail pharmacy, law enforcement, health care providers, visiting nurses associations, local government agencies and other providers A Provide an example of a call script with convenient and informative messaging for residents to 2. Provide messaging with a primarily focus on educating residents to use drop-off locations that is 3. Provide an example of plain language and explanatory images that promotes consumer education and use of drop-off locations for residents with limited English proficiency. 4. Provide a description of distribution of materials to include retail pharmacy, law enforcement, health care providers, visiting nurses associations, local government agencies and other providers. A producer or group of producers participating in the standard stewardship plan or an independent stewardship plan shall work with collectors participating in their stewardship plan to develop clear, standardized instructions for residents on the use of drop boxes and a readily recognizable, consistent design of drop boxes. The local hazardous waste management program may provide guidance to producers and collectors on the development of the instructions and design. King County Secure Medicine Return Regulations Stewardship Plan Evaluation - King County MED-Project, LLC Page 9 of 11