British Columbia Medications Returns Program Plan 2012 to 2018

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British Columbia Medications Returns Program Plan 2012 to 2018
British Columbia Medications Returns Program Plan
                  2012 to 2018
British Columbia Medications Returns Program Plan 2012 to 2018
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

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British Columbia Medications Returns Program Plan 2012 to 2018
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

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British Columbia Medications Returns Program Plan 2012 to 2018
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.

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British Columbia Medications Returns Program Plan 2012 to 2018
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.

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British Columbia Medications Returns Program Plan 2012 to 2018
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.

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British Columbia Medications Returns Program Plan 2012 to 2018
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.

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British Columbia Medications Returns Program Plan 2012 to 2018
   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.

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British Columbia Medications Returns Program Plan 2012 to 2018
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).

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British Columbia Medications Returns Program Plan 2012 to 2018
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.

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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.

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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.

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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

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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

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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.

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   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
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