British Columbia Medications Returns Program Plan 2012 to 2018
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
Contents 1. Definitions ............................................................................................................................................. 4 2. Product Stewardship Plan ..................................................................................................................... 5 3. Recycling Regulation Requirements ..................................................................................................... 5 4. The Stewardship Association ................................................................................................................ 6 A.) Mandate and Purpose................................................................................................................... 6 B.) Governance ................................................................................................................................... 6 5. Stakeholder Consultation...................................................................................................................... 7 6. Medications Return Program Overview ................................................................................................... 7 A.) Pharmacies .................................................................................................................................... 8 B.) Acceptable Medications................................................................................................................ 9 C.) Non-Acceptable Medications........................................................................................................ 9 D.) Program Administrator ................................................................................................................. 9 E.) Funding ......................................................................................................................................... 9 i.) Prescription Drugs ....................................................................................................................... 10 ii.) Natural Health Products / Over-the-Counter Medications..................................................... 10 7. Educational Materials and Strategies ................................................................................................. 10 A.) Publicity....................................................................................................................................... 10 B.) Printed Materials ........................................................................................................................ 10 C.) Other Resources.......................................................................................................................... 11 8. Program Performance Measurement ................................................................................................. 11 A.) Consumer Awareness ................................................................................................................. 11 B.) Number of Collection Points ....................................................................................................... 12 C.) Product Recovery Target............................................................................................................. 14 D.) Promotion ................................................................................................................................... 15 E.) Waste Composition Studies ........................................................................................................ 17 F.) Summary Table of Performance Measures. ............................................................................... 17 9. Third Party Assurance Requirements for Non-Financial Information ................................................ 18 10. Compliance Process ........................................................................................................................ 18 11. Dispute Resolution .......................................................................................................................... 19 12. Pollution Prevention Hierarchy ....................................................................................................... 20 13. Environmental Impact Throughout Product Lifecycle .................................................................... 20 A.) Safety, Social and Environmental Impact ................................................................................... 20 2
i.) Safety Risk ................................................................................................................................... 20 ii.) Societal Risk - Abuse and Diversion ........................................................................................ 21 iii.) Environment............................................................................................................................ 21 14. Waste Disposal Sites ....................................................................................................................... 22 15. Annual Report ................................................................................................................................. 22 Appendix A: Stakeholder Consultation Summary ....................................................................................... 23 Appendix B: New Pharmacy Registration Form and Protocol/Agreement................................................. 33 Appendix C: Pharmacy E-News ................................................................................................................... 36 Appendix D: 2011 Stewards ........................................................................................................................ 38 Appendix E: Consumer Awareness Survey ................................................................................................. 40 Appendix F: Participating Pharmacies ........................................................................................................ 41 Appendix G: Ambassador Program ............................................................................................................. 51 Appendix H: British Columbia Pharmacist’s Association Campaign ........................................................... 52 Appendix I: HPSA Promotional and Educational Activities 2012 ................................................................ 63 Appendix J: Product Monograph ................................................................................................................ 66 3
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. Program Administrator: The individual or business who is contracted to manage the BC Medications Return Program in British Columbia. Recovery Rate: Means 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. 4
2. Product Stewardship Plan 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 both products clearly attributable to an existing steward, and orphan products. Orphan products are those that are no longer in production, the 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 1,025 collection sites across the whole province and the public has returned approximately 296,836 kg of unused or expired health products for environmentally responsible disposal. 3. Recycling Regulation Requirements In accordance with the requirements of an approved stewardship plan, there must be a review of the plan 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 effective, cost efficient, environmentally and socially responsible health products return program for consumers on behalf of more than 140 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
4. The Stewardship Association A.) Mandate and Purpose The Health Products Stewardship Association (HPSA), formerly known as the Post-Consumer Product Stewardship Association is a not-for-profit industry stewardship organization that meets its obligations, as outlined in the BC extra provincial Society Act, and files the required reports with the Corporate Property Registry Branch of the Ministry of Finance. HPSA has been registered with Industry Canada since 2000. The HPSA has been appointed as the agency to meet producer’s regulatory obligations as health products stewards. HPSA’s role is to perform on behalf of each member certain duties required under the regulation. As of December 2010, HPSA’s membership was established at 140 stewards. The Program is accountable to its members, the general public and the government of British Columbia, through the Ministry of Environment. The Program performance is publically accountable through the annual report. B.) Governance HPSA is a member-based association representing obligated stewards of health products, as defined in the Recycling Regulation. HPSA operates according to the bylaws approved by the Board to manage the affairs of the association. A nine-member Board of Directors is elected by the stewards. The Board members are committed to maintaining a high standard of corporate governance. The directors have the responsibility for the overall stewardship of the association, establishing the policies and standards for the association. The current list of the Board of Directors is available on the HPSA website (www.healthsteward.ca). The Executive Director reports to the Board and is responsible for operations management, financial management, communications and general administrative duties. As required by regulation, HPSA has operated a province-wide Medications Return Program for prescriptions drugs, non-prescription drugs and natural health products since April 1998. The pharmaceutical product category is regulated in Canada under the Food and Drugs Act and Regulations and the Natural Health Products Regulations. Unlike other programs developed under the Recycling Regulation (Paint and HHW, Electronics, Oil, etc.) the BCMRP is fully funded by the health product industries. 6
5. Stakeholder Consultation Section 5 (1) (b) of the regulation requires the producer to have undertaken satisfactory consultation with stakeholders prior to submitting the plan for approval and will provide opportunity for stakeholder input in the implementation and operation of the product stewardship program. For the first time ever, stakeholders were invited to attend joint public consultation meetings for the review of four BC product stewardship plans: Tire Stewardship BC, the Electronic Stewardship Association of BC, Product Care Association and the Health Products Stewardship Association. The joint consultation sessions were held as follow: Prince George - Wednesday May 25, 2011 – Ramada Inn Kelowna - Friday May 27, 2011 – Coast Capri Hotel Nanaimo - Monday May 30, 2011 – Coast Bastion Inn New Westminster - Tuesday May 31, 2011 – Inn at the Quay People could register online at www.bcstewardconsultations.ca and could download a copy of the product stewardship plans from each agency`s website. HPSA’s stewardship plan was posted by May 5th, 2011 for public comment and the deadline for submission of written comments on HPSA’s plan was June 17, 2011. Advance notifications were sent out on April 18th to 329 common stakeholders such as senior government, stewardship associations, ENGOs (including RCBC), Regional Districts and municipalities. A notice was also sent to HPSA’s member stewards and collection sites on May 15th. A total of 84 individuals participated in the four consultation sessions and eight written submissions were received by the deadline. HPSA’s presentation at the consultation sessions provided an overview of the plan as well as opportunities to ask questions and provide feedback Appendix A. provides a summary of the questions and comments received. Where possible, like comments have been grouped together for ease of response and in doing so HPSA has tried to maintain the essence of the public’s input without distortion. 6. Medications Return Program Overview The collection sites for the BCMRP are primarily community pharmacies. Pharmacy managers interested in participating must complete a registration form. Details on the program are provided to ensure that pharmacy management and staff are knowledgeable on the program and its operation. All participating community pharmacies receive information with instructions on the program, order form and containers and sign and return a Protocol/Agreement to HPSA (Appendix B). Once the registration form is completed and faxed to our office, the pharmacist is contacted by phone to discuss the following points: The program is for returns from the public. Large quantities from individuals are acceptable. 7
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 contacts the program administrator to schedule a delivery and pick up. 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. Collection in Kilograms A.) Pharmacies The plan adequately provides for 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 1,025 representing 94.5% of licensed community pharmacies in the province. HPSA provides promotional items (posters, brochures, flyers, etc.) for display and has developed a news bulletin circulated annually in the spring and fall (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. In addition: Pharmacies are a natural, logical and safe site for the public to return health products. They also offer easy access to those with special needs and varying degrees of personal mobility. Pharmacists are very knowledgeable about dispensing health products and do 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. 8
The following lists provide an example of materials that would be acceptable. Note that this list is not exhaustive. B.) Acceptable Medications All prescription drugs Non-prescription health products Natural health products Vitamin and mineral supplements C.) Non-Acceptable Medications Sharps, needles or syringes Cosmetics Antiperspirants, antiseptic Skin cleansers Mouthwashes Hard surface and disinfectant cleaners Expired samples from physicians‟ offices Unused or expired drugs from hospitals Pharmaceuticals from farms and veterinary products D.) Program Administrator The HPSA contracts with a program administrator for the following: Maintain and update database on participating community pharmacies. Collection of expired and unused health products from community pharmacies. Storage, transfer and secure disposal of products. Ensuring all necessary environmental permits and licenses are obtained. E.) Funding HPSA is responsible for ensuring that brand-owners/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, transportation, storage, promotion and disposal of products within the BC program. The cost of operating the BCMRP is shared between brand owners of health products (prescriptions drugs and natural health products). Updated lists of participating brand-owners are also published on the HPSA website. HPSA conducts yearly reviews to identify and confirm brand-owners/producers selling health products in British Columbia (Appendix D). 9
i.) Prescription Drugs The market share for brand owners of prescription drugs is based on all products dispensed in British Columbia in the previous calendar year. There is no minimum rate, however there is an administrative charge covering operations established yearly and approved at the 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 sales in previous calendar year of affected natural health products in British Columbia. There is no dominium, however there is an administrative charge covering operations established yearly and approved at the AGM. 7. Educational Materials and Strategies HPSA’s promotional and educational strategies are designed to ensure 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 associates such as Regional District Service offices and municipalities. The brochures provide clear directions on what is accepted and not accepted in the BCMRP, how to return the unused or expired health products and where returns are accepted in an easy fashion. HPSA offers its support to health awareness events and health trade shows with advertising 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 reorder system by fax, email or through the website. Brochures are presently available in English, while 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 published by Regional Districts and municipalities informing residents about municipal services. Mail Outs: HPSA will provide promotional material to Regional Districts and municipalities or other groups/organizations interested in promoting the program. News Bulletins: These are currently available on a quarterly basis to HPSA members. HPSA also provides a bi-annual e-bulletin for the community pharmacy managers. 10
Local Newspapers: HPSA has produced articles in community newspapers promoting the B.C. Medications Return Program. Other initiatives take place during the Pharmacist Awareness Week and other health related events during the year. C.) Other Resources Web Site: The HPSA website (www.healthsteward.ca) provides the public with information on the program and locations of collection sites for the disposal of health products. The site also provides a searchable database of participating pharmacies and details on products accepted by the program. As HPSA continues to build the membership base, it can utilize the members’ own promotional network to advertize the B.C. Medications Return Program. These initiatives are described in Annual Reports. RCBC Toll-Free and Recyclopedia: HPSA has partnered with the Recycling Council of British Columbia recycling hotline service and sponsored the newly expended on-line recycling information database called Recyclopedia. Consumer Information: Information on the safe use, storage and disposal is provided to the consumer at the time of purchase. HPSA sends regular updates to Regional Districts and municipalities including key messages and logos that can be used to promote safe disposal of unused or expired health products. 8. Program Performance Measurement The regulation requires that the plan make 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/prescribed in the Province of B.C. are done so with the intent to be 100% consumed therefore the use of a “recovery rate” calculation is not applicable. The BC MRP is a mature EPR program with very high collection location penetration and increasing collection volumes. As a result, HPSA will evaluate the success of the program through the following five categories: 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. A.) Consumer Awareness A consumer awareness survey was developed in 2007 and used again in September 2010, and shows significant improvements in both consumer behavior and awareness of the program (Appendix E). Repeated consumer awareness surveys will take place at specific intervals as the BCMRP further matures over time and are a tool used to help measure program performance and usage. 11
HPSA remains committed to the consumer awareness targets for 2013 and 2018 which include a 25 % increase in public awareness and a 10% increase in usage of the BCMRP compared to the 2012 results where: 60% of British Columbians were able to identify pharmacies as a place where consumer may dispose of unwanted medications. 61% used the program in the last 6 months. Given the current levels, HPSA believes that 75% is an aggressive and realistic target for public awareness for 2018. HPSA will endeavour to raise the levels of public awareness to targets requested by the Ministry for programs in future years. Awareness Indicators: Target until 2018: Increase public awareness by 25% and usage of Program by 10%. 75% of British Columbians are able to identify pharmacies as a place where consumers may dispose of unwanted medications. 68% have used the program in the last six months. Performance measures: Measure changes in awareness and behaviour. Strategies: Year 1 Work with BC Stewards to increase exposure through communications and other events. Year 2 - 3 Maintain publicity in annual recycling calendars (12) and continue to support special events (2). Year 4 Measure awareness and usage of program with public survey. Year 5-6 To increase partnership in promotion and awareness through health related association organisations. Year 7 Measure awareness and usage of program with public survey. To be developed based on results in year 4. B.) Number of Collection Points Section 5 (1) (c) (iii) of the regulation requires that a plan must adequately provide for 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 centers 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 can be found in Appendix F. The provincial average is 3,713 people per HPSA registered collection location. 12
Collection Locations Per Capita by District Population Collection Locations per District Collected (kgs) Population Area (km2) Density Locations (#) Capita Alberni-Clayoquot 482.3 31,061 6,588 4.71 11 2,824 Bulkley-Nechako 562.31 39,208 73,361 0.53 13 3,016 Capital 11712.97 359,991 2,340 153.84 102 3,529 Cariboo 944.15 62,392 80,609 0.77 17 3,670 Central Kootenay 1465.03 58,441 22,095 2.64 20 2,922 Central Okanagan 4826.76 179,839 2,905 61.91 54 3,330 Columbia-Shuswap 822.4 50,512 28,929 1.75 15 3,368 Comox Valley 1270.05 63,568 1,701 37.37 17 3,739 Courtenay 77.31 3,206 24,492 0.13 1 3,206 Cowichan Valley 2372.14 80,332 3,475 23.12 22 3,651 East Kootenay 750.1 56,685 27,543 2.06 20 2,834 Fraser Valley 6121.1 277,593 13,335 20.82 64 4,337 Fraser-Fort George 1185.39 91,879 50,676 1.81 23 3,995 Kitimat-Stikine 421.11 37,361 104,461 0.36 10 3,736 Kootenay Boundary 631.1 31,138 8,082 3.85 15 2,075 Metro Vancouver 45075.23 2,313,328 2,883 802.40 592 3,908 Mount Waddington 111.51 11,506 20,244 0.57 4 2,877 Nanaimo 4919.43 146,574 2,038 71.92 44 3,331 North Okanogan 1678.63 81,237 7,503 10.83 20 4,062 Northern Rockies 33.8 5,578 85,111 0.07 2 2,789 Okanagan-Similkameen 2090.33 80,742 10,414 7.75 28 2,884 Peace River 430.9 60,082 117,391 0.51 15 4,005 Powell River 145.4 19,906 5,075 3.92 6 3,318 Skeena-Queen Charlotte 128.1 18,784 19,781 0.95 4 4,696 Squamish-Lillooet 492.3 38,170 16,310 2.34 12 3,180 Strathcona 779.1 43,252 18,278 2.37 15 2,883 Sunshine Coast 469.7 28,619 3,777 7.58 9 3,180 Thompson-Nicola 3092.51 128,473 44,448 2.89 30 4,282 13
Accessibility Indicators: Target until 2018: Maintain a pharmacy program participation rate of 95% on a three year rolling average. Performance measure: Report percentage of sites who have returned containers in the last 24 months. HPSA’s contracted collector of medications waste provides HPSA with collection location activity reports showing 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 and if they need any shipping containers or promotional material about the BCMRP. Strategies: Year 1 Contact new licensed community pharmacies on a quarterly basis; contacts 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. Year 2 - 3 Review and adjust to maintain registration. Year 4 Review and adjust to maintain registration. Year 5-6-7 Review and adjust to maintain registration with a focus on determining whether expansion to underserviced regions of the province is required. 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. Quantity Collected: Target until 2018 Increase tonnage collected to 95 tons in 2018. Maintain a minimum quantity collected of 85 tons 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 (e.g. Pharmacy 14
Awareness week, retailer’s own promotional initiatives). Year 2 Continue to work with members and community pharmacies to organize special collection events and publicize program. Promote program in different media. Year 3 and 4 Continue to work with members and community pharmacies with special collection events and publicity from retailers. Year 5 To be developed based on public survey results in year 4. Year 6 and 7 Continue to work with members and community pharmacies with special collection events and publicity from retailers. D.) Promotion Section 5 (1) (c) (iv) (A) to (C) under the regulation require that the plan adequately provides for making consumers aware of the BCMRP, the 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. Pharmacies that are registered collection locations 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. Promotion Indicators: Target until 2018 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 coordinators 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‟ organizations, such as nurses, physicians and home- care personnel. 15
Display signage in pharmacy on the BCMRP. Year 2 and 3 Track traffic to BC page and access to locations. Work with communication 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 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. Year 5 to 7 Hold a minimum of 12 special events, such as community pharmacy based events. Review the public awareness strategy based on the information gathered in previous years. For the second year in a row the British Columbia Used Oil Management Association (BCUOMA) partnered with the Electronic Stewardship Association of BC (ESABC), Product Care (PC) and HPSA’s (formerly the Post-Consumer Pharmaceutical Stewardship Association) Medications Return Program. Along with visiting used oil RCFs, a steward Ambassador Team visited facilities specific to each steward, promoted the relevant recycling programs at community events and gathered stewardship-specific feedback from government representatives. Results of the Ambassador Program found in the “BC Used Oil Summer Ambassador Program 2012 Summer Report at: http://www.usedoilrecycling.com/resources/file/BC/BCUOMA_Summer_Ambassador_Program_2012_Fi nal_Report_without_PC.pdf. HPSA highlights from the report can be found in Appendix G. The British Columbia Pharmacist’s Association (BCPA) initiated a campaign that involved more than 480 pharmacies who received promotional materials such as prescription bag stuffers and shelf signs promoting the BCMRP. The BCPA worked with 6 Regional Districts (Metro Vancouver, Capital, Peace River, Squamish Lillooet, North Okanagan and Comox Valley) to promote the program through their social media, websites, recycling calendars, newsletters, etc. They also put out 5 joint news releases (one with each Regional District except Peace River). Details on the campaign can be found in Appendix H. Other HPSA promotional activities for 2012 are listed in Appendix I. 16
E.) Waste Composition Studies HPSA joined with the BC Stewards Group to formalize a working partnership with Regional Districts to conduct detailed waste audits to determine the makeup of the waste stream. It is anticipated that the reports derived from these audits will be analyzed and used by stewards as one of many tools to establish the effectiveness of their 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. Waste Composition Study: Target until 2018: 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 Draft and approve the BC Stewards waste audit proposal. Year 2 - 3 Establish a partnership agreement for participating in scheduled waste audits performed in five Regional Districts. Year 4-5 Review and develop a guide for participating in Waste Composition Study Year 6 - 7 Help fund waste composition studies through the BC stewards. F.) Summary Table of Performance Measures. Performance Measure 2012 2013 2014 2015 2016 2017 2018 Awareness Indicators: Measure Change in Awareness and Behaviour 1. Public Awareness 60% 63% 65% 68% 71% 73% 75% 2. Program Usage 61% 63% 64% 65% 66% 67% 68% Accessibility Indicators: Report on Sites That Returned Containers (24 Months) % of Community Pharmacies 95% 92% 95% 95% 95% 95% 95% Quantity Collected: Report Total Volume Collected Yearly Tonnes Collected 65 65 85 90 92 94 95 17
9. 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; Total amount of product sold and collected; and Management of product collected in accordance with the pollution prevention hierarchy HPSA prepares annual audited statement for all three of these core elements that verify the mass balance of materials in aggregate as they flow in 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 At the pharmacy the driver affixes a bar code label to each HPSA collection container and uses a handheld device to scan a barcode on the HPSA container. The driver leaves the desired amount of replacement container(s) with a receipt from the Driver’s handheld device documenting 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 bill of lading/manifest 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 collected from other sites are consolidated and 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. 10. Compliance Process Compliance process and enforcement measures are central to ensure 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 from HPSA. Exceptions can be made if the Board determines that the producer/brand-owner is not covered by the regulations (excluded 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: 18
1st contact (60 days prior): Letter is sent to obligate 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 with a deadline for submitting membership documents and payments toward the plan is sent by HPSA. At this point, the Board will consider each steward on a case-by-case basis to approve final step. 4th contact: A request for non-compliance actions is sent to the Ministry of Environment with a copy to the steward. 11. Dispute Resolution Section 5 (1) (c) (vi) of the Recycling Regulation requires that a plan provide for a dispute resolution procedure. 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 exclusively by and shall be 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. In the first instance be referred to representatives of the parties for resolution in a professional and amicable manner by negotiation within five days of notification. 2. A dispute which has not been resolved by the party’s representatives within fifteen (15) Business Days of its being referred to them for resolution may be submitted to non-binding mediation, through the use of a mutually agreeable dispute resolution process. 3. If the dispute has not been referred to mediation or has been referred to mediation but is not resolved by mediation within a further fifteen (15) Business Days after being referred to a mediator, it may be submitted by either party for determination through arbitration under the Commercial Arbitration Act (British Columbia). 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 shall be conducted by a single arbitrator appointed in accordance with BCIAC Rules in Vancouver, BC and the award of the arbitrator including any award as to costs will be final and binding on the 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. 19
12. Pollution Prevention Hierarchy The pollution prevention hierarchy (recycle, recover, 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, efficacy, and quality. Health products are consumable products. 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/producers have been able to give excess health products with adequate shelf life (usually 6 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 3rd party verification is obtained by HPSA. 13. Environmental Impact Throughout Product Lifecycle Over the last 5 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). In addition, since 2010, all BCMRP containers have been replaced with reusable 30 L containers. HPSA has also partnered with some chains (e.g.: Shoppers Drug Mart) to distribute paper bags to help with medicine cabinet clean-up and reduce the impact of pharmaceuticals entering the environment. This medications return campaign will be evaluated. A.) Safety, Social and Environmental Impact The BCMRP is designed to help mitigate the following safety, societal and environmental risks 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% of them say they stole them 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/expired medications in the home and that the proper storage and handling of these unused/expired medications is essential to avoid accidental ingestion by household members and 20
pets. A key component of that message is promoting 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 BCMRP and 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 ) and are present in the post-consumer pharmaceutical waste stream. The 2009 U.S. National Survey on Drug Use and Health found that 70% 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 or the opportunity 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 put in place to create the necessary program accessibility to help prevent abuse and diversion. iii.) Environment A 2008 study by Statistics Canada showed that nearly 40% 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 and remove them from the waste water stream and as a result they pass through the process and are released into the environment. There is no reuse or recycling application for post-consumer unused/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 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.). 21
There is a need for more research in the area of the toxicity of pharmaceutical released into the environment. For that reason it is not practical to measure the extent to which the BCMRP prevents the release of toxic substances into the environment. 14. Waste Disposal Sites It is not appropriate for health products to be returned with other household hazardous waste and handled by individuals not used to handling health products. HPSA prefers that health products are returned to a pharmacy location. Pharmacies are more knowledgeable in handling health products and offer a secure environment for safe disposal. HPSA only partners with licensed service providers with a proven record of using established, approved and verifiable procedures for the final treatment and processing of residuals in compliance with all applicable environmental regulations. 15. Annual Report On or before July 1 each year the HPSA shall submit to the Director a report of the Association’s activities for the preceding calendar year. The report will document the performance in relation to the plan. The report will also be available on the HPSA web site. 22
Appendix A: Stakeholder Consultation Summary 23
24
We have distilled four hours of discussion and eight written comments into the following table: Terminology Answer Comment/Questions Term medication is misleading as natural health The expression health product is frequently products are not considered medications. accompanied by additional clarification such as: including prescription drugs, non-prescription drugs and natural health products. This program was established before Health Canada created (in the 1990s) a separate regulatory framework for natural health products. ‘Consumer health product’ should be replaced, Based on consultation, we will add in the glossary: or natural health product should be explicitly stated. Consumer health products: health products sold to consumers. Term Consumer health products not clearly Health products: prescription drugs, non- understood to consumers prescription drugs and natural health products. Natural health products: Vitamins and minerals Herbal remedies Homeopathic medicines Traditional Chinese medicines Probiotics Other products like amino acids and essential fatty acids What is risk associated with misuse of This Recycling Regulation applies to products supplements? under NPH’s definition, not specific to natural supplements. Program is designed to meet the requirements of the Recycling Regulation which stipulates that all types of products be included in the program regardless of their merit for safe disposal and toxicity. The Recycling Regulation, B.C. 449/2004 refers The purpose of the program plan is to bridge to the Pharmaceutical product category and not between the language in the regulation and more to medications. Unclear if the regulations explicit working language. NHP’s are clearly require that Natural Health Products be included in the definition of products captured by included in this program. the program. Does the program include sharps? Program does not include sharps. Different product category that is yet to be regulated. Does program include Epi-Pens? Should not be in our containers as medications are 25
shipped as non-bio hazard waste. Will there be something on website of how to We direct people to BCPhA, but we could put link get rid of other materials (sharps)? Put a link. on website. Expand range of products to include hospitals, B.C. regulations exempts those sectors. doctor’s office, institutions, farms and veterinary products. Packaging/containers Vials and packaging are excluded from the program plan. This program was established to provide a safe disposal option for medications through pharmacies; Public is encouraged to bring in medications in original container and place medications in our containers. The original regulatory obligation referred to the product and not the packaging. Recommend to pharmacies and the public to recycle the containers. Can the stewards in the natural health industry Public education is only one component. Also need meet the requirements of the regulation by a collection system that follows the 5 Rs. A public only providing education to the public about education program, on its own, would not meet safe disposal options? the requirements of the regulation. Will there be a program in place for packaging? Yes, they will be included in the new packaging and printed materials program that was just announced this week. Board of Directors Answer Comment/Questions Explicit representation from the natural health PCPSA is a member (health products industries) product and small business sector should be based association; election and appointment of all stipulated in the bylaws and be made publicly directors are held during AGM. Equal available. representation of sectors (brand name, generic and consumer health industries) is in the by-laws. CHFA represents 1000 members that are fully Notice to PCPSA’s members was circulated, in our engaged in the natural health product sector newsletters (January/April) and through direct e- with our members ranging from suppliers to mail announcement in April. independent health food store retailers. Despite this fact, we were only afforded 4 days The majority of industries affected by this notice prior to this consultation session. regulation are currently registered and Following our attendance at the consultation participating in the program. session, CHFA does not feel that our concerns with the program and the inclusion of natural Suppliers and retailers, unless they own a brand health products have been addressed and private label are not targeted by this appropriately by either PCPSA or the BC regulation. Ministry of the Environment. Questions on the product definition should be 26
addressed to the Ministry and not through public consultation; these sessions are to evaluate program plans. Believe that the fee base is unfair for NHP’s. Fee Fees are not based on risks but on quantity base should be proportional to environmental generated/sales. Fee structure is reviewed by the risk. Board of Directors If memberships disagree; they can propose a change in the funding model through elected directors on the board. Members can vote on a proposed revised revenue model. Collection Answer Comment/Questions What assurance can be provided or checks and We do verify containers to ensure compliance both balances are in place to ensure that pre- with product definition (cosmetics)/consumer consumer damaged products, whose disposal is returns vs pharmacy waste (stale dated product). paid for as part of a commercial transaction between the vendor and the retailer, are not Suppliers are not funding the program, only brand disposed of through the post-consumer owners. mechanism and hence double paid for by suppliers of natural health products. CHFA strongly recommends that the option to PCPSA advocates community pharmacies for the act as a collection location for natural health public to return unused or expired health products be expanded beyond pharmacies to products. Nonetheless, we have expanded our include all locations for where natural health collection sites to other locations such as clinics, products are sold. health center and, hospitals when applicable. New locations are assessed based on completing an application form available on our website at www.medicationsreturn.ca . There is no need to involve a pharmacist for That is correct; however the program covers a unscheduled natural health products wide range of products in addition to NHP’s. 80% of products returned are prescription drugs. Add clarity that damaged pre-consumer goods Clarification on acceptable products is found in the as a result of normal retail and distribution protocol and agreement, provided upon practices are not accepted into the return registration. Appendix B. program described in this document Independent Health food Stores should also be All registered collection sites are listed, regardless specifically listed of type of business. Unused or expired drugs from hospitals and B.C. Regulation exempts these sectors. institutions are excluded from the program Is there a diversion rate target? No. Only consumer access, consumer awareness, and % of people that have used the program. 27
You can also read