(1) Each program operator shall submit an annual report to the department by July 1st in the format provided by the department.

(2) To ensure consistency of program operator reporting and ensure the department can accurately analyze the data, the annual program report must include:

(a) A list of covered manufacturers participating with the program operator.

(b) The amount, by weight, of covered drugs collected, including the amount by weight from each collection method used.

(c) The list of collection sites with addresses must:

(i) Indicate collection sites added since previous annual report was submitted to the department;

(ii) Also be provided as a map; and

(iii) Identify any retail pharmacy, hospital or clinic with an on-site pharmacy, or law enforcement agency that offered to participate and was not included as an authorized collector within 90 days of the program operator receiving offer.

(A) If potential authorized collector was included later, describe reason for delay.

(B) If potential authorized collector was not included, describe reason for exclusion.

(d) A description of prompt collection, maintenance, and kiosk inner liner supply requests.

(i) Describe whether agreements with collection sites include requirement for collection site to report need for prompt collection, maintenance, or inner liner supplies.

(ii) Describe any instances where program operator identified issues related to collection receptacle (kiosk) not being available to accept covered drugs when collection site was open for business, including issues identified during program operator inspection of receptacles; number of requests for prompt collection, maintenance, or inner liner supplies; and average number of days between request and collection or response.

(iii) Describe any instances where requests for prompt collection, maintenance, or inner liner supplies were not provided by the program operator as described in their approved plan. The description shall include the reason prompt collection, maintenance, or inner liner supplies were not provided and the number of days between request and collection or response.

(e) The number of mailers provided as reported by zip code and must include the number of mailers provided for each of the following categories:

(i) Directly to individuals as the result of requests made through website or toll-free telephone number;

(ii) Directly to households without anyone requesting them;

(iii) To retail pharmacies that are not mail-back distribution locations;

(iv) To other businesses or organizations that are not mail-back distribution locations; and

(v) To mail-back distribution locations.

(f) The locations where mailers were provided and must include a list of:

(i) Zip codes where individuals requested mailers from the single website, single toll-free telephone number, program operator specific website, or program operator specific telephone number;

(ii) Zip codes where households were sent mailers directly without requesting them. This list must indicate the percentage of households per zip codes that were sent mailers;

(iii) Nonresidential locations that are not mail-back distribution locations with addresses; and

(iv) Mail-back distribution locations with addresses.

(g) Dates and locations of collection events held.

(h) A description of collection sites, mail-back distribution locations, take-back events, and other methods for accessing safe medication return in areas outside of population centers.

(i) List all law enforcement, retail pharmacies, and hospitals or clinics with on-site pharmacies on islands and outside population centers and indicate whether they are authorized collectors.

(ii) For each law enforcement facility, retail pharmacy, and hospital or clinic with on-site pharmacy that is not an authorized collector, describe the reason they are not participating. Include recruitment efforts and the result of those efforts.

(i) Transporters and disposal facilities used.

(j) Safety or security problems including, but not limited to, all instances where collection, transportation, or disposal did not follow processes described in the approved plan, including processes for prompt collection and maintenance. Safety and security problems described must include any instances where a secure collection receptacle (kiosk) is opened for a reason other than packaging the inner liner for shipping, installing a new inner liner, or maintenance on a kiosk that does not contain an inner liner. The description of whether safety or security problems occurred during collection, transportation, or disposal of covered drugs must include:

(i) Whether the problem occurred during collection, transportation, or disposal;

(ii) Whether the problem met criteria for reporting to law enforcement, Washington state pharmacy quality assurance commission, United States Drug Enforcement Administration, or other entity and whether the operator can confirm that the reporting happened;

(iii) If covered drugs were lost during transportation, whether transporter has policies for safely managing undeliverable packages that might include drugs;

(iv) If transporter delivered covered drugs to the wrong address, description of attempts to retrieve covered drugs and whether those attempts were successful;

(v) Program operator actions to ensure problem was reported, if required; appropriate investigation occurred; and risk of similar problem occurring in the future was minimized; and

(vi) Changes to policies, procedures, or tracking mechanisms to address the problem and improve safety and security.

(k) A description of public education, outreach, and evaluation activities implemented and shall include the following. "Promotional material" shall have the same definition as in WAC 246-480-070(4):

(i) List of languages that printed or downloadable public promotional material are available in, with description of any printed or downloadable promotional material not available in these languages. List or description of languages used in any television, radio, social media, or other nonprint promotional material;

(ii) List or description of languages available on the single website and program operator specific website; the single toll-free telephone number and program operator specific telephone number; and call centers associated with the single toll-free telephone number and program operator specific telephone number. This list or description must include the name of language service providers where applicable;

(iii) Description of how these languages or language services meet the language needs of people in Washington;

(iv) Copies of all public promotional material, including signage and changes to websites and telephone number scripts, developed since last annual report;

(v) Description of how education and outreach efforts were implemented including:

(A) Date, type, and description of all social media and email promotion activity;

(B) Date, frequency, reach, and description of outreach for radio, television, print, and digital media platforms;

(C) List of brochures and posters available from single website and program operator specific website, number of times each was viewed, and number of times each was downloaded;

(D) Name, address, facility type, and date of email or hard copy distribution of brochures and posters to nonresidential entities; and

(E) Total number of views and number of unique visitors for each page of single website and program operator specific website.

(vi) Description of evaluation activities shall include:

(A) Evaluation of comments, questions, and concerns received from the public including evaluation of feedback themes and actions program operator has implemented or planned in response to feedback; and

(B) Evaluation of public education and outreach efforts, including evaluation of education and outreach implementation described in (g)(v) of this subsection.

(l) A description of how collected packaging was recycled to the extent feasible.

(m) A summary of the program's goals for collection amounts and public awareness shall include:

(i) Description of goals for the reporting year;

(ii) Description of goals for the following year, including identification of any unmet goals carried forward; and

(iii) Description of how program operator calculates or quantifies progress toward goals, including any percentages included in goals.

(n) A summary of degree of success in meeting goals shall include description of why goals were not met and what effort program operator will make to achieve those goals the following year.

(o) The program's annual expenditures, itemized by program category shall be organized using the criteria described in WAC 246-480-040(5).