British Columbia Medications Return Program Plan 2017 and beyond
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Contents 1. Definitions ............................................................................................................................................. 1 2. Executive Summary………………………………………………………………………………………………………………………….2 3. Program Products ................................................................................................................................. 2 4. Recycling Regulation Requirements ..................................................................................................... 3 5. The Health Products Stewardship Association ..................................................................................... 3 a) Mandate and Purpose....................................................................................................................... 3 b) Membership ...................................................................................................................................... 4 c) Directors and Meetings..................................................................................................................... 4 d) Funding ............................................................................................................................................. 4 6. Stakeholder Consultation...................................................................................................................... 5 7. Product Management ........................................................................................................................... 5 Table 1. Collection in Kilograms ............................................................................................................ 6 a) Pharmacies ........................................................................................................................................ 7 b) Acceptable Medications.................................................................................................................... 7 c) Non-Acceptable Medications............................................................................................................ 7 d) Service Providers ............................................................................................................................... 7 8. Educational Materials and Strategies ................................................................................................... 8 a) Publicity............................................................................................................................................. 8 b) Printed Materials .............................................................................................................................. 8 c) Other Resources................................................................................................................................ 8 9. Program Performance Measurement ................................................................................................... 9 a) Consumer Awareness Survey............................................................................................................ 9 Table 2 Consumer Awareness Targets ................................................................................................ 11 b) Number of Collection Points ........................................................................................................... 12 Table 3. Collection Locations Per Capita by District............................................................................ 13 Table 4. Accessibility Indicators: ......................................................................................................... 14 c) Product Recovery Target................................................................................................................. 15 Table 5. Quantity Collected:................................................................................................................ 15 d) Promotion ....................................................................................................................................... 15 HPSA BC Stewardship Plan 2017 i
Table 6. Promotion Indicators: ........................................................................................................... 16 e) Waste Composition Studies ............................................................................................................ 17 Table 7. Waste Composition Studies: ................................................................................................. 17 Table 8 Summary Table of Performance Targets ................................................................................ 18 10. Third Party Assurance Requirements for Non-Financial Information ........................................ 18 11. Compliance Process ........................................................................................................................ 19 12. Dispute Resolution .......................................................................................................................... 20 13. Product Life Cycle and Pollution Prevention Hierarchy .................................................................. 21 14. Environmental Impact Throughout Product Lifecycle .................................................................... 21 a) Safety, Social and Environmental Impact ....................................................................................... 21 15. Waste Disposal Sites ....................................................................................................................... 23 16. Annual Report ................................................................................................................................. 23 Appendix A: Registration Form/BCMPR Standards Agreement……………………………………………………………..Error! Bookmark not defined.25 Appendix B: News Bulletin .....................................................................…..Error! Bookmark not defined.28 Appendix C: Members List .......................................................................................................................... 29 Appendix D: 2012 Survey Results ............................................................................................................... 30 Appendix E: Registered Pharmacies ........................................................................................................... 33 Appendix F: Ambassador Program ............................................................................................................. 44 Appendix G: British Columbia Pharmacist’s Association Campaign ........................................................... 45 Appendix H: HPSA Promotional and Educational Materials………….…………………………………………….…………46 Appendix I: Product Monograph……………………………………………………………………………………………………………47 HPSA BC Stewardship Plan 2017 ii
1. Definitions The following terminology is used throughout the Recycling Regulation, and this document: Collection Sites: Community pharmacies who are registered in the program to collect unused and expired health products from the public. Consumer Health Products: Health products sold to consumers. Health Products: Prescription drugs, non-prescription drugs, and natural health products. Member: Brand-owner/steward who is a member of the association. Natural Health Products: Vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines such as traditional Chinese medicines, probiotics, and other products like amino acids and essential fatty acids. Recovery Rate: The amount of product collected, divided by the amount of product generated, expressed as a percentage. Regulation: Recycling Regulation, B.C. 449/2004. Stewards: (i) A person who manufactures a pharmaceutical product and sells, offers for sale, or distributes a pharmaceutical product in British Columbia under its own brand; or, (ii) A person who is not the manufacturer of a pharmaceutical product, but is the owner or licensee of a trademark, under which the pharmaceutical product is sold or distributed in British Columbia, whether or not they own the Drug Identification Number. (iii) If subparagraphs (i) and (ii) do not apply, a person who imports the product in the province for sale or distribution. Stakeholders: Person or organization whose interests will be, or are affected by, the provisions of a proposed plan.
2. Executive Summary HPSA and its industry members implemented and have been operating the British Columbia Medications Return Program since 1996, which is one of the first products obligated under the Post- Consumer Residual Stewardship Program Regulation. In 2004, the B.C. Government passed the B.C. Reg. 449/2004 (the “Regulation”) to update obligations and standards for all EPR programs. Our last stewardship plan – under the new regulation – was approved by the B.C. Ministry of Environment in 2007. This stewardship plan was developed on behalf of health industries’, brand owners of prescription drugs, over-the counter medications, and natural health products sold in British Columbia through community pharmacies. The 2017 and beyond has been drafted in accordance with the requirements of the Regulation. The plan also details the program’s health product collection and management systems, as well as its communication initiatives – which intend to further build on the successes of HPSA’s current disposal system through community pharmacies. 3. Program Products This plan is designed to collect and properly dispose of unused or expired health products from the residential sector. Products included in this plan are: All prescriptions drugs: All dosage forms; Over-the-counter medications: Units sold in oral dosage form; Natural health products: Units sold in oral dosage form. The program includes products that are attributable to an existing steward, as well as orphan products -- which are products that are no longer in production because the product steward is no longer in business, or products are purchased outside Canada. The Program’s goals are to: • run a province-wide, industry-administered product stewardship program in compliance with the Regulation; • ensure that the public is able to return expired and unused health products for disposal throughout the province; • provide a convenient system for the collection and disposal of expired and unused health products; • provide the public with information on the location of collection sites; • ensure that collection sites accept products from the public free of charge; • achieve performance requirements or targets established in the plan; • ensure environmentally sound disposal of expired and unused health products. Since 2000, the program has grown from 575 to 1,224 collection sites across the whole province, and the public returned approximately 100,000 kg of unused or expired health products for environmentally responsible disposal in 2016. HPSA BC Stewardship Plan 2017 2
4. Recycling Regulation Requirements In accordance with the requirements of an approved stewardship plan, the plan must be reviewed every five years. According to Section 6 of the Recycling Regulation, a producer must review its approved plan; and, a) submit to a director proposed amendments to the approved plan; or, b) advise a director in writing that no amendments to the approved plan are necessary. The British Columbia Medications Return Program (BCMRP) has developed and delivered an efficient, cost-effective, environmentally and socially responsible health products return program for consumers, on behalf of more than 165 producers. This plan describes the current program, and the priorities for the next five-year period, in the context of the approval criteria set forth in the regulation. 5. The Health Products Stewardship Association a) Mandate and Purpose The Health Products Stewardship Association (HPSA) is a not-for-profit industry stewardship organization that meets its obligations, as outlined in the B.C. Extra-provincial Society Act, and files the required reports with the Corporate Property Registry Branch of the Ministry of Finance. HPSA was registered with Industry Canada in 2000, and was continued under the Canada Not-for-Profit Corporations Act by the issuance of a Certificate of Continuance for Health Products Stewardship Association on April 29, 2013, by the federal government, through Industry Canada. The Letter of Continuance reflects a name change, as well as new by-laws in line with the NFP Act. The HPSA has been appointed as the agency to meet producers’ regulatory obligations as health products stewards. HPSA’s role is to perform certain duties required under the regulation, on behalf of each member. As of October 2016, HPSA’s membership was established at 165 stewards. The board members are committed to maintaining a high standard of corporate governance. The directors are responsible for the overall stewardship of the association, as well as establishing the policies and standards for the association. The list of current board of directors and its by-laws are available on the HPSA website (www.healthsteward.ca). The corporation’s current purposes, as set out in the Articles of Continuance under the NFP Act, are as follows: • To be the steward for environmental waste management programs of post-consumer health products. • To manage unused or expired post-consumer health products in a cost-efficient and environmentally acceptable manner, that meets government policy or legislation for its members. HPSA BC Stewardship Plan 2017 3
The structure for the corporation, and the means by which it carries on its daily activities, were established in the General Operating By-law on April 25, 2013. A copy of the General Operation By-law was forwarded to Industry Canada for their records on May 14, 2013. b) Membership • The corporation, as a non-share capital corporation, is required to be structured as a membership- based corporation, operated by members and directors. • In this regard, the corporation is structured as “closed membership”, i.e. the directors and the members are one and the same person. (HPSA is a member-based association representing obligated stewards of health products). • The classes of members, and their rights, are set out in the Articles of Continuance. • Conditions of membership are set out in Section 11 of the General Operating By-law. • The process for termination of membership is set out in Section 18 of the General Operating By-law. • Decisions made by the members are reflected by a resolution. • Resolutions are recorded as part of the members’ minutes. They are signed by either the chair of the board, or the secretary. c) Directors and Meetings • Members meetings are governed by Section 13 of the General Operating By-law. • The governance, administration, and management of the corporation lie with the board of directors, who are accountable to its members. • Qualification requirements for directors are set out in Section 31 of the General Operating By-law. Only those persons meeting these qualification requirements may become directors of the corporation. • The number of directors is set out in the Articles of Continuance (minimum 4, maximum 12). • Directors of the corporation are elected into office by resolution of the members of the corporation. • The election, appointment, term of office, resignation, removal, and filling vacancies of directors are governed by Sections 32 to 35 of the General Operating By-law. • It must have a minimum of three directors, at least two of whom are not officers of employees, or officers of the corporation or its affiliates. • The association must file annual financial statements with Industry Canada. • The association must comply with higher requirements, in terms of the appointment of public accountant, and the level of review of its financial statements. d) Funding HPSA is responsible for ensuring that brand-owners and producers who sell, offer for sale, or distribute health products in British Columbia are covering their share of the costs to the Program. Funding from the industry covers all expenses incurred in the collection, such as transportation, storage, promotion, and the disposal of products within the B.C. program. Participating industries are published on the HPSA website. HPSA conducts yearly reviews to identify and confirm brand-owners and producers selling health products in British Columbia (Appendix D). The association’s fiscal year-end is the thirty-first day of December of each year. Corporate contracts and documents are signed by any two officers or directors. HPSA BC Stewardship Plan 2017 4
A public accountant (auditor) is appointed annually to conduct an audit. The association has an operating reserve of up to six months of operating funds. i. Prescription Drugs The market share for brand owners of prescription drugs is based on the previous year’s products that were dispensed in British Columbia. There is no minimum rate; however, there is an administrative charge that covers operations, which is established yearly once approved at the annual AGM. ii. Natural Health Products / Over-the-Counter Medications The market share for brand owners for over-the-counter drugs and natural health products is based on how the number of sales in the previous calendar year of affected natural health products in British Columbia. There is no minimum contribution; however, there is an administrative charge, which is determined yearly, that covers operations costs. This fee is established and approved annually at the AGM. 6. Stakeholder Consultation Section 5 (1) (b) of the regulation requires the producer to have consulted with stakeholders about their program satisfaction prior to submitting the plan for approval. This provides stakeholders with the opportunity to weigh in on their experiences with the product stewardship program. Individuals were able to register for a webinar, as well as download a copy of the product stewardship plan from HPSA’s website. The stewardship plan was posted by October 20, 2016 for comments. The deadline for submission was November 30, 2016. Advance notifications were sent out on October 13 through RCBC, as well as stakeholders, such as senior government staff, stewardship association, regional districts, and municipalities and collections sties participants. A total of 45 individuals attended the webinar and we will note written comments once comments period is completed in Appendix J. HPSA’s presentation at the consultation session, held during the CWMA annual meeting in Victoria, British Columbia, provided an overview of the plan – as well as opportunities to ask questions and provide feedback. Appendix g. provides a summary of the questions and comments received. Where possible, similar comments have been grouped together for ease of response and, in doing so, HPSA intends to maintain the essence of the public’s input, without distortion. 7. Product Management The collection sites for the BCMRP are primarily community pharmacies. Pharmacy managers interested in participating must complete a registration form (Appendix A). Details on the program are provided to ensure that pharmacy management and staff are knowledgeable about the program, and its operations. HPSA BC Stewardship Plan 2017 5
All participating community pharmacies receive information with instruction on the program, order form, and containers. All pharmacies sign and return an agreement to HPSA prior participating. Once the registration form is completed and faxed to HPSA’s office, the pharmacist is contacted by an HPSA staff member, who provides them with such crucial information as: • The program is for returns from the public. • Large quantities from individuals are acceptable. • All dry health products can be dropped directly into the plastic disposal container, including blister packs and inhalers in their original package. • All liquid products are accepted but they are not to be poured into the disposal container. • This program does not accept sharps, needles or syringes. • All extra packaging should be removed; including personal information. Once the container is full, the pharmacist completes a pick-up and delivery request form for services. All containers received from a pharmacy are tracked by weight, pickup date, and location, and re-packaged for safe destruction at a licensed incineration facility. Table 1. Collection in Kilograms 120000 100000 80000 60000 40000 20000 0 2009 2010 2011 2012 2013 2014 2015 HPSA BC Stewardship Plan 2017 6
a) Pharmacies The plan adequately provides reasonable and free consumer access to collection facilities, as required under Section 5 (1) (c) (iii) of the regulation. Since 2000, HPSA has increased the number of registered pharmacies from 575 to 1,224, which represents 95.1 per cent of licensed community pharmacies in the province. HPSA provides promotional items (posters, rack cards, bookmarks, etc.) for display, and has a news bulletin that circulates bi-annually (spring and fall) (See Appendix C). There is no charge to the consumer to return products. Community pharmacies currently participating in the program can be easily located by the public on the HPSA website at www.healthsteward.ca, or by accessing the Recycling Council of British Columbia Encyclopedia at www.rcbc.bc.ca. Additionally: • Pharmacies are a natural, logical and safe site for the public to return health products; • They offer easy access to those with special needs and varying degrees of personal mobility; • Pharmacists are very knowledgeable about dispensing health products and provide advice on individual medical condition and proper use of health products; • Many of these pharmacies are open during extended hours, offering a convenient place for consumer disposal year-round; and, • HPSA also allows clinics, health authorities, and some hospitals to participate in areas – without adequate coverage, such as island and first nations territories. The following lists provide some examples of materials that would be acceptable. b) Acceptable Medications • All prescription drugs • Non-prescription health products • Natural health products c) Non-Acceptable Medications • Sharps, needles, or syringes • Cosmetics • Skin cleansers, unless prescribed • Hard surface and disinfectant cleaners • Unused or expired drugs from hospitals and clinics • Farm and veterinary products d) Service Providers While ensuring all necessary environmental permits and licenses are in place, HPSA contracts service providers for the following duties: • The collection of expired and unused health products from community pharmacies; and, • the storage, transfer, and secure disposal of products. HPSA BC Stewardship Plan 2017 7
8. Educational Materials and Strategies HPSA’s promotional and educational strategies are designed to ensure that the citizens of B.C. know where and how to dispose of unused or expired medications when necessary. a) Publicity The program has posters, brochures, flyers, bookmarks, etc. that can quickly be supplied to participating pharmacies, special events, or other associations, such as Regional District Service offices and municipalities. The brochures outline what is accepted and not accepted in the BCMRP, how to return the unused or expired health products, and where returns are accessible. HPSA offers its support to health awareness events and health trade shows with advertisements with messages that focus on the responsible disposal of unused or expired health products. b) Printed Materials Take-Aways: Brochures and point-of-purchase signage are distributed to pharmacies and other locations, such as clinics and doctor’s offices, through a re-order system by fax, e-mail, or through the website. Brochures are presently available in English, and bookmarks are available in four languages (English, French, Punjabi, and Chinese). Municipal Garbage and Recycling Calendars: HPSA will continue to promote the B.C. Medications Return Program in the recycling calendar, which is published by regional districts and municipalities to inform residents about municipal services. Mail Outs: HPSA will provide promotional material to regional districts and municipalities, and other groups/organizations interested in promoting the program. News Bulletins: News bulletins are currently available on a quarterly basis to HPSA members. HPSA also provides a bi-annual e-bulletin for the community pharmacy managers. Local Newspapers: HPSA has produced articles in community newspapers promoting the B.C. Medications Return Program. c) Other Resources Web Site: The HPSA website (www.healthsteward.ca) provides the public with information on its program, and locations of collection sites for the disposal of health products. The site also provides a searchable database of participating pharmacies, and details which products are accepted by the program. As HPSA continues to build its membership base, it can utilize the members’ own promotional network to advertise the B.C. Medications Return Program. These initiatives are detailed in HPSA’s annual reports. RCBC Toll-Free and Recyclopedia: HPSA has partnered with the Recycling Council of British Columbia’s recycling hotline service to sponsor the newly expended online recycling information database called Recyclopedia. HPSA BC Stewardship Plan 2017 8
Consumer Information: Information on the safe use, storage, and disposal is provided to the consumer at the time of purchase. Appendix j Monogram Medications Return Campaign. The B.C. Medications Return Program is held each year by HPSA, in collaboration with the B.C. Pharmacy Association. Other key partners, such as the Vancouver Police Department, Metro Vancouver, Capital Regional District, and London Drugs hold in-store campaign events to urge the public to safely dispose of their medications. The campaign includes videos, news releases in all regional areas, and a media event in Vancouver with participating pharmacies. (Appendix H). Other initiatives are taking place during Pharmacist Awareness Week, National Prescription Drop-off day, and other health-related events throughout the year. 9. Program Performance Measurement The regulation requires that the plan makes adequate provisions for informing consumers of the producer’s product stewardship program, the location of collection facilities, and how to handle products in a safe manner -- as well as the environmental and economic benefits of participating in the program. Medications that are sold and/or prescribed in the province of B.C. are done so with the intent to be 100 per cent consumed; therefore, the use of a “recovery rate” calculation is not applicable. The B.C. MRP is a mature EPR program with very high collection location penetration and increasing collection volumes. As a result, HPSA and other stewards within B.C. Stewardship Association have developed a tool to evaluate the successes of stewardship programs through Matrix, which measures the following performance indicators: awareness indicators, accessibility indicators, quantity collected, promotion indicators, and waste composition studies. HPSA has been tracking and reporting on many of these key indicators since 2006, and will continue to improve this tool, so that can be used in all our programs in Canada. a) Consumer Awareness Survey A consumer awareness survey was developed in 2007, and used from September 2010-2013, and again in 2016. The survey shows significant improvements in both consumer awareness and behaviour (Appendix E). Repeated consumer awareness surveys have taken place at specific intervals. This tool is used to help measure program performance and usage. HPSA remains committed to its consumer awareness targets for 2019 and 2021, which include a three per cent increase in public awareness and an five per cent increase in usage of the BCMRP, compared to the 2016 results where: 67 per cent amongst the general population knew there was a program in place for safely disposing of unwanted medications; however, amongst those who had medications in their home, there is a statistically significant increase from 67 to 73 per cent; and, HPSA BC Stewardship Plan 2017 9
47 per cent of all respondents have used our program in the past 12 months while amongst those that currently have medications 55 per cent have used our program in the past 12 months. Both statistics are showing significant increase in awareness and usage as well as significant decrease of medications currently or usually available in household. Given the current levels, HPSA believes that a 75 per cent increase is an aggressive but realistic target for public awareness by 2021. HPSA will endeavour to raise the levels of public awareness to the targets requested by the Ministry. Tactics may include: Advertising Online Advertising o Search Engine Marketing (SEM) through relevant keywords o Impression retargeting – delivering relevant content based on users’ search habits o Display advertising (retail, banner stores, etc.) on relevant third-party sites Print Advertising o Including relevant mass market and industry publications, municipal calendars Broadcast Advertising o Public Service Announcements (PSAs) for broad reaching messages (University Campus) Direct Mail o Distribution of branded, informative program materials to targeted groups, through chains, drugs store flyers, and other means Information Resources Point of Sale (PoS) and Point of Return (PoR) Materials o Materials, such as program posters and brochures, for existing retailers and collection sites, are made readily available, and free to the public Program Website o The program will continue to regularly update and maintain the website to make program information easily available for all audiences through the use of: Geographically searchable Collection Site Finder Collection site hours and operations Program accepted product lists Toll-free Number o The program will continue to operate a toll-free customer service to answer queries Partnerships HPSA will leverage positive working relationships with key new and existing industry partners, in effort to advance program awareness and use. Partnerships may include: HPSA BC Stewardship Plan 2017 10
Health authorities; Not-for-profit health organizations, such as the Heart and Stroke Foundation, MS Society, etc. and, Stewardship industry groups such as the Recycling Council of British Columbia (who operate the RCBC Hotline and Recyclepedia search tools), and the Stewardship Association of British Columbia (who operate the B.C. Recycles information resource, bcrecycles.ca). Community Events The program may pursue a presence at relevant third-party events to raise awareness and, where appropriate, provide product collection services. Social Media The program will continue to employ its social media channels (including, but not limited to, Facebook, Consumer Awareness Targets To measure the performance of the communications strategy, the program proposes to conduct a consumer awareness survey every three years. In 2013, the program conducted a survey and found that 58 per cent of British Columbians were able to identify pharmacies as a place where they may return unwanted medications. The program is targeting an eight per cent increase in consumer awareness beyond 2016 levels by 2021 to 73 per cent). Table 2 Consumer Awareness Targets • Target until 2021: • Increase public awareness and usage of Program by three to five per cent. • 75 per cent of British Columbians are able to identify pharmacies as a place where consumers may dispose of unwanted medications • 54 per cent have used the program in the last six months • Performance measures: • Measure changes in awareness and behaviour • Strategies: • Year 1 • Work with B.C. Stewards to increase exposure through communications and other events • Hire Communications Manager • Year 2 • Maintain publicity in annual recycling calendars (12), and continue to support special events (2) • Year 3 • Measure awareness and usage of program with public survey • Year 4 • To be completed in year one • Year 5 • Measure awareness and usage of program with public survey • To be developed based on results in year four HPSA BC Stewardship Plan 2017 11
b) Number of Collection Points Section 5 (1) (c) (iii) of the regulation requires that a plan must adequately provide reasonable and free consumer access to collection facilities. Since 1997, HPSA has established a comprehensive network of permanent collection sites under the BCMRP where the public can conveniently return health products for responsible disposal. This network consists of community pharmacies as well as some clinics, hospitals, community centres, and other collections sites with a significant volume of consumer returns. HPSA produces an annual District Summary Report that shows the number of registered collection locations per capita by district, and demonstrates the high level of consumer access and program coverage in B.C. A list of participating pharmacies, which can be found in Appendix F. The provincial average is under 4,000 people, per HPSA registered collection location. HPSA BC Stewardship Plan 2017 12
Table 3. Collection Locations Per Capita by District 2015 Volumes Population Population Collection Locations per Regional District (kgs) (2011) Area (km2) Density Locations (#) Capita Alberni-Clayoquot 560.7 31,061 6,588 4.71 13 2,389 Bulkley-Nechako 701.12 39,208 73,361 0.53 13 3,016 Capital 11306.04 359,991 2,340 153.81 101 3,564 Cariboo 934.32 62,392 80,609 0.77 17 3,670 Central Kootenay 1468.41 58,441 22,095 2.64 18 3,247 Central Okanagan 4667.73 179,839 2,905 61.91 49 3,670 Columbia-Shuswap 1018.3 50,512 28,929 1.75 14 3,608 Comox Valley 1813.05 63,538 1,701 37.37 15 4,236 Cowichan Valley 2611.43 80,332 3,475 23.12 20 4,017 East Kootenay 1129.9 56,685 27,543 2.06 19 2,983 Fraser Valley 5446.05 277,593 13,335 20.81 72 3,855 Fraser-Fort George 1834.42 91,879 50,676 1.81 23 3,995 Kitimat-Stikine 790.67 37,361 104,461 0.36 9 4,151 Kootenay Boundary 778.3 31,138 8,082 3.85 14 2,224 Metro Vancouver 49472.3 2,313,328 2,883 802.40 631 3,666 Mount Waddington 194.32 11,506 20,244 0.57 4 2,877 Nanaimo 4519.86 146,574 2,038 71.93 44 3,331 North Okanogan 2156.31 81,237 7,503 10.82 22 3,693 Okanagan-Similkameen 2336.24 80,742 10,414 7.75 29 2,784 Peace River 496.56 60,082 117,391 0.51 16 3,755 Powell River 366.96 19,906 5,075 3.92 7 2,844 Skeena-Queen Charlotte 277.8 18,784 19,781 0.95 6 3,131 Squamish-Lillooet 723.64 38,171 16,310 2.34 13 2,936 Strathcona 1208.22 43,252 18,278 2.37 14 3,089 Sunshine Coast 530.4 28,619 3,777 7.57 8 3,577 Thompson-Nicola 2831.03 128,473 44,448 2.89 33 3,893 Totals 100,174 4,390,644 1,224 HPSA BC Stewardship Plan 2017 13
Table 4. Accessibility Indicators: • Target until 2021: • Maintain a pharmacy program participation rate of 95 per cent on a three-year rolling average • Performance measure: • Report percentage of sites who have returned containers over the past 24 months • HPSA’s contracted collector of medications waste to provide HPSA with collection location activity reports, which shows the last date a community pharmacy generated medications waste under the BCMRP. Pharmacies that have not generated medications waste in over 12 months are contacted by HPSA to determine if they are still registered in the program ,if they need shipping containers, or to be provided with promotional material about the BCMRP • Strategies: • Year 1 • Contact new licensed community pharmacies on a quarterly basis; contacts will be obtained through the College of Pharmacists in B.C. • Contact existing pharmacies with ownership and/or manager changes on a quarterly basis • Contact pharmacies with a significant change in collection pattern consistently • Year 2 4 • Review and adjust to maintain registration • Year 5 • Review and adjust to maintain registration with a focus on determining whether expansion to underserviced regions of the province is required HPSA BC Stewardship Plan 2017 14
c) Product Recovery Target Under Section 5 (1) (a) (i) of the Recycling Regulation, recovery rate is defined as the amount of product collected divided by the amount of product generated, expressed as a percentage. Recovery rates are a good method to measure program success for many designated materials but this method is not to medications in determining the effectiveness of the BCMRP. Table 5. Quantity Collected: • Target until 2021 • Increase tonnage collected to 110 tonnes in 2021. • Maintain a minimum quantity collected of 105 tonnes on a three-year rolling average, throughout the duration of the plan • Performance measure: • Report total quantity collected on a yearly basis, with quarterly results by regional districts • Strategies: • Year 1 • Promote program at special events (i.e. Pharmacy Awareness week, retailers’ own promotional initiatives). • Year 2 • Continue to work with members and community pharmacies to organize special collection events, and publicize program. Promote program through various media relations strategies and platforms • Year 3 and 4 • Continue to work with members and community pharmacies with special collection events and publicity from retailers • Year 5 • Will be developed, based on public survey results in year four d) Promotion Section 5 (1) (c) (iv) (A) to (C), under the regulation, requires that the plan adequately provides consumers with information to assist in raising awareness about the BCMRP, locations of participating pharmacies, and how returned medications should be managed in a safe manner. The promotion indicators below demonstrate what is being done by HPSA to increase consumer awareness. Registered collection location pharmacies in the BCMRP can easily be located by consumers on the HPSA web site (www.healthsteward.ca) by entering a postal code, or address and province in the return locator on the welcome page. HPSA BC Stewardship Plan 2017 15
Table 6. Promotion Indicators: • Target until 2021 • Publicity on the BCMRP in 25 Regional Districts or municipalities‟ websites with recycling sections • Promotion of program in participating pharmacies and other sites • Performance measure: • Increase in awareness of the BCMRP • Strategies: • Year 1 • Contract out website development and design • HPSA will maintain a website to locate collection sites with easy access to information on the program • Maintain contact with waste co-ordinators in regional districts/municipalities with promotional material (video) and key messages for their websites/display area • Indication of program in recycling calendars or with information distributed directly to households • Work with pharmacists and their professional associations to craft messages about the program • Connect with other health professionals, , such as nurses, physicians, and home-care personnel • Display BCMPR signage in pharmacies • Year 2 and 3 • Track traffic to B.C. page • Work with communications firm for the promotion and advertising plan development on the program • Connect with pharmacists and help disseminate information on the program through the Ambassador or similar initiatives • Work with chain and independent pharmacies to increase the availability of collection bags for the public • Hold a minimum of 12 special events, such as community pharmacy based events • Year 4-5 • Follow-up on advertising on regional district/municipality websites and annual calendars • Evaluate the outcome of our promotional program through a public survey • Evaluate the participation/awareness of pharmacists on promoting the program to their customer • Hold a minimum of 12 special events, such as community pharmacy based events with a focus on the Regional Districts with low per capita collection rates We partnered with the British Columbia Used Oil Management Association (BCUOMA), the Electronic Stewardship Association of B.C. (ESABC), Product Care (PC) and five other stewardship associations. HPSA BC Stewardship Plan 2017 16
Along with visiting Used Oil RCFs, steward ambassador teams visited facilities specific to each steward. For HPSA, they visited 56 collections sites to promote the relevant recycling programs at community events. The ambassadors gathered stewardship-specific feedback from government representatives and pharmacy managers. The total reach of the events was 808,150. The most successful events continue to be Khatsalano Festival, Cloverdale Rodeo, Sunset Beach Festival, and Abbotsford Air Show. Web traffic on the BC Recycles website was increased by 80 per cent, as a result of engaged 25-64-year-old new visitors. Through a cross-promotional effort between stewardships, social media efforts on Facebook, Instagram, Snapchat and Twitter had a total reach of 76,682, and a growth of 100 per cent. This was achieved organically, not advertisements or posts were sponsored through these platforms. The summer event was featured in community newspapers across British Columbia, and Global News aired a televised interview with the ambassadors. Additional HPSA highlights from the 2016 report can be found in Appendix F. The British Columbia Pharmacist’s Association (BCPhA) initiated a campaign that involved more than 480 pharmacies who received promotional materials, such as prescription bag stuffers and shelf signs, which promoted the BCMRP. The BCPhA worked with regional districts to promote the program through their social media, websites, recycling calendars, newsletters, etc. They also put out news releases. Details on the campaign can be found in Appendix J. e) Waste Composition Studies HPSA joined the B.C. Stewards Group to formalize a working partnership with regional districts to conduct detailed waste audits that determine the makeup of the waste stream. It is anticipated that the reports derived from these audits can be analyzed and used by stewards as one of many tools to establish the effectiveness of its programs in accordance with the requirements of the Recycling Regulation. The resulting information will assist the partners in achieving the long-term goal of zero waste. For the regional districts that conduct waste composition studies, these studies should be statistically significant to establish the presence of health products within the Household Hazardous Waste categories. HPSA BC Stewardship Plan 2017 17
Table 7. Waste Composition Studies: • Target until 2021: • Decrease the presence of health products in waste composition studies • Performance measure: • Report amounts of regulated products estimated in statistically significant waste composition studies • Strategies: • Year 1 • Review and develop a guide for participating in Waste Composition Study • Year 2 - 3 • Help fund waste composition studies through the B.C. stewards • Year 4-5 • Review and develop a guide for participating in Waste Composition Study Table 8 Summary Table of Performance Targets Performance Measure 2017 2018 2018 2020 2021 Public Awareness 69% 71% 73% 74% 75% Program Usage 49% 51% 53% 54% 54% % of Community Pharmacies 95% 95% 95% 95% 95% Tonnes Collected 100 102 105 107 110 10. Third Party Assurance Requirements for Non-Financial Information HPSA has the following elements of third-party assurance requirements for non-financial audits: • The number and location of collection facilities; • The total amount of product sold and collected; and, • The management of products collected in accordance with the pollution prevention hierarchy HPSA prepares audited statements for all three of these core elements, annually. These statements verify the mass balance of combined materials, as they flow through the “chain of custody” as follows: • A community pharmacy registered in the HPSA program is typically scheduled on a service frequency based upon their historical waste generation. The pharmacy may also initiate a request for pickup to HPSA • A truck is dispatched to the pharmacy to pick up the HPSA pail of medications HPSA BC Stewardship Plan 2017 18
• At the pharmacy the driver attaches a bar code label to each HPSA collection container, and uses a handheld device to scan a barcode onto each container • The driver leaves the desired amount of replacement container(s) with a receipt from the driver’s handheld device, which documents the number of waste containers collected, and the supply of new collection containers • The driver estimates the weight of the medications pail, and records it on a lading and manifest bill document • The medications pail is delivered to an approved transfer and processing facility where each container’s bar code is scanned to validate receipt, and ensure the number of containers collected at each pharmacy is equal to the number of containers received at the facility • HPSA medications pails that are collected from other sites are consolidated, weighed, manifested, and shipped to an HPSA approved disposal facility • At the disposal facility, the medications are weighed to verify the received weight, incinerated, and a Certificate of Destruction is provided to HPSA 11. Compliance Process Compliance process and enforcement measures are essential to ensuring full compliance of all obligated parties. For the purposes of initiating actions with the British Columbia Ministry of Environment, non- compliance is defined as a lack of responsiveness from a brand-owner/producer after more than two notices on producers’ responsibilities have been sent by HPSA. Exceptions can be made if the board determines that the producer and/or brand-owner is not covered by the regulations (excluding products), or fees are paid by a third party. In the event that HPSA does not receive a financial contribution from stewards within the prescribed timeframe(s), HPSA management may utilize the following notifications to underscore the importance of timely submission: 1st contact (60 days prior): A letter is sent to obligated stewards under the Recycling Regulation, informing them of their responsibilities. HPSA’s role is to advise any potential stewards, and offer the approved Medications Return Program as a way to fulfill their regulatory requirements. 2nd contact (90 days): A second letter is sent to a steward for lack of reply from the previous correspondence. At this point in time, HPSA will point out that they are liable if their company contravenes the Act. 3rd contact (120 days): A final letter is sent by HPSA, which details the deadline for submitting membership documents and payments towards the plan. At this point, the board will consider each steward on a case-by-case basis to approve the final step. 4th contact: A request for non-compliance actions is sent to the Ministry of Environment. A copy of this document is sent to the steward. HPSA BC Stewardship Plan 2017 19
12. Dispute Resolution Section 5 (1) (c) (vi) of the Recycling Regulation requires that a plan for a dispute resolution procedure be provided. Any person or organization believing that the responsibilities of parties participating in the Medications Return Program do not meet the requirements of the program plan should immediately provide a detailed description of the complaint to HPSA as follows: By e-mail to ginette.vanasse@healthsteward.ca By fax to 613-723-0779 By phone to 613-723-7282 Any dispute arising out of, or in connection with, a person, organization, or BCMRP service provider shall be governed, enforced, construed, and interpreted exclusively, in accordance with the laws of British Columbia, and the laws of Canada applicable in British Columbia, which will be deemed to be the proper law of the contract. A dispute that arises due to the interpretation of a service agreement will: 1. Be referred to representatives of the parties for resolution, in a professional and amicable manner, by negotiation within five days of notification. 2. Be submitted to non-binding mediation, through the use of a mutually agreeable dispute resolution process, if it is not solved by a party’s representatives within 15 business days. 3. Be submitted by either party for determination through arbitration, under the Commercial Arbitration Act (British Columbia), if the dispute has not been referred to mediation – or has been referred to mediation, but is not resolved by mediation – within a further 15 business days after being referred to a mediator. The arbitration will be governed by the British Columbia International Commercial Arbitration Centre, in accordance with its “Domestic Commercial Arbitration Rules of Procedure” (“BCIAC Rules”). The arbitration will be conducted by a single arbitrator that is appointed in accordance with BCIAC Rules in Vancouver, B.C. The award of the arbitrator, including any award as to costs, will be final and binding on both parties. The reference to arbitration will not preclude a party from applying to a British Columbia court of competent jurisdiction for interlocutory or interim relief. HPSA BC Stewardship Plan 2017 20
13. Product Life Cycle and Pollution Prevention Hierarchy The pollution prevention hierarchy (recycle, recover, and residual disposal) requirements, outlined in Section 5(1)(c)(viii) of the Recycling Regulation, are intended to reduce the environmental impact of health products, but are not feasible without affecting pharmaceutical product safety, efficiency, and quality. Health products are consumable products. As such, health products are taken for specific conditions or symptoms, and should be fully consumed unless otherwise indicated by a health professional. Health products cannot be reused or recycled, as other products covered under this regulation. Some manufacturers and producers have been able to give excess health products, with adequate shelf lives, (usually six months) for humanitarian use. This unique situation eliminates or reduces a product that is consumable; however, it does not apply to products that have been purchased by a consumer. Products collected under this program will be securely disposed of through incineration at government- licensed facilities. A Certificate of Destruction, as well as third party verification will be optained by HPSA. 14. Environmental Impact Throughout Product Lifecycle Over the last five years, HPSA members have undertaken environmental initiatives that have improved the environmental impact of health products. As a performance measure, individual stewards have also made some changes to product monographs, which reflect the program’s ability to influence change in a positive manner. Product monographs (patient medication information sheets) are starting to indicate safe disposal options (see example in Appendix J). Additionally, since 2010, all BCMRP containers have been replaced with reusable 30 L containers. HPSA has also partnered with some chains (i.e. Shoppers Drug Mart, Loblaw, and Rexall) to distribute paper bags that will assist with medicine cabinet clean-up, and reduce the impact of pharmaceuticals entering the environment. a) Safety, Social and Environmental Impact The BCMRP is designed to help mitigate the following safety, societal, and environmental risks that are associated with unused medications in the home. i. Safety Risk One teenager in five has admitted to taking prescription drugs to get high, and 75 per cent of teenagers claim to have stolen drugs from home (Source: CAMH – Ontario Student Drug Use and Health Survey (2009 OSDUHS)). In 2007, 23,783 cases of accidental exposure to another person’s medicine were reported to poison control centres in the United States (Source: Bronstein et al. 2007 Annual Report of the American Association of Poison Control Centers' National Poison Data System (NPDS): 25th Annual Report. Clin Toxicol (Phila). 2008;46(10):927-1057). The BCMRP promotes consumer awareness and education about the dangers of unused and expired medications in the home. The British Columbia HPSA BC Stewardship Plan 2017 21
Medications Return Program promotes proper storage and handling of all unused and expired medications, as it is essential to avoiding accidental ingestion by household members and pets. A key component of conveying that message is to promote the use of BCMRP registered community pharmacy collection locations as the proper venue for disposing of these materials. ii. Societal Risk - Abuse and Diversion It is important for prescription drugs to be disposed of properly through the BCMR – not left in the home where they can be easily abused or diverted. Opioids, central nervous system depressants and stimulants, are the most commonly misused classes of prescription drugs (Source: National Institute on Drug Abuse, http://www.drugabuse.gov/publications/drugfacts/prescription-over-counter-medications ). Opioids are also present in the post-consumer pharmaceutical waste stream. The 2009 U.S. National Survey on Drug Use and Health found that 70 per cent of people aged 12 or older used pain relievers non-medicinally in the past year – many of which were likely obtained from a home medicine cabinet. Unused quantities of medications in the home creates the opportunity for abuse through unauthorized consumption, as well as for diversion into the black market. Educating consumers on abuse and diversion, promoting community pharmacy collection locations, and contracting a safe and secure service provider to collect and dispose of medications from pharmacies are all critical components of the BCMRP that HPSA has set safeguards against through accessibility to its necessary program. iii. Environment A 2008 study by Statistics Canada showed that nearly 40 per cent of Canadian households disposed of their unused or expired medications by dumping them down the drain, flushing them down the toilet, or putting them in their curbside garbage (Source: Statistics Canada Disposal of Household Special Wastes. http://www.drugabuse.gov/publications/drugfacts/prescription-over-counter-medications). Sewage treatment plants are not designed to effectively treat these kinds of substances, nor can they remove them from the waste water streams. As a result, medications pass through the process and are released into the environment. There is no reuse or recycling application for post-consumer unused and expired medications. Medications must be completely destroyed through incineration. The tonnages of medications collected by the BCMRP has kept this material out of our landfills, and wastewater treatment systems, which has been beneficial to the environment. Due to the nature of an EPR program for pharmaceuticals, an environmental performance measurement system is problematic. The amount of eligible pharmaceutical, over-the-counter, and natural health products introduced into B.C. can be calculated based on prescriptions or units sold but, according to the USEPA, “…quantities of production or consumptions do not correspond with the quantities of pharmaceuticals and personal care products (PPCPs) introduced into the environment” (Source: USEPA web site http://epa.gov/ppcp/faq.html#quantities). The USEPA also notes that, “To date, scientists have found no evidence of adverse human health effects from PPCPs in the environment.” (Source: USEPA web site http://epa.gov/ppcp/faq.html#quantities). Additionally, aquatic species that bio accumulate pharmaceutical, personal care, of veterinary products – and have been subjected to toxicity tests – show that lethal effects are unlikely in the environment; but, that long term effects are possible (Source: Pharmaceuticals and Personal Care Products in the Canadian Environment: Research and Policy Directions. Dr. Francois Gagne, p.10-11.). HPSA BC Stewardship Plan 2017 22
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