PROGRAM’PLAN FOR$THE$ ONTARIOSHARPS’COLLECTION...

PROGRAM PLAN FOR THE ONTARIO SHARPS COLLECTION PROGRAM

MAY 2013

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EXECUTIVE SUMMARY Ontario Regulation 298/12 "Collection of Pharmaceuticals and Sharps - Responsibility of Producers" came into force on October 2nd, 2012 under the Ontario Environmental Protection Act (EPA). This is the first time the EPA has been used as an instrument to establish standards for extended producer responsibility (EPR) and hold producers (i.e. manufacturers, brand owners or first importers) directly liable for the end-of-life management of their post-consumer pharmaceutical, natural health and sharps product wastes. The Ontario Sharps Collection Program (OSCP) addresses EPR for all types of sharps sold for use in the province of Ontario but is limited to the “consumer” waste stream. The program is designed to ensure that collection service is available to all regions of the province and all returned sharps are collected, handled, stored, packaged, transported and disposed of in a safe, compliant and environmentally responsible manner. The OSCP is administered by the Health Products Stewardship Association (HPSA), a not-for-profit industry funding organization (IFO), established in 1999. The HPSA was formerly known as the Post Consumer Pharmaceutical Stewardship Association (PCPSA). HPSA was formed to provide the health product industries with a collective means for managing their extended producer responsibilities including the associated product liability and regulatory compliance requirements that vary from province to province. The following OSCP plan has been developed by HPSA with input from sharps producers, provincial policy makers and regulators, EPR experts and trade associations. Producers are required to comply with Regulation 298/12 therefore many sections of the regulation have been incorporated directly into this program plan. The OSCP plan covers the three year period beginning October 1, 2012 through to December 31, 2015, after which the program plan will undergo a comprehensive review. This plan has been posted on the HPSA web site (www.healthsteward.ca) for the general public and other interested stakeholders to review.

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TABLE OF CONTENTS

EXECUTIVE SUMMARY ................................................................................................................................. 2

TABLE OF CONTENTS .................................................................................................................................... 3

1. GLOSSARY OF KEY DEFINITIONS AND ACRONYMS ............................................................................... 5

1.1 Acronyms ............................................................................................................................................ 5

1.2 Terms and Definitions ........................................................................................................................ 5

2. INTRODUCTION .................................................................................................................................... 8

2.1 Regulatory Review .............................................................................................................................. 8

2.1.1 Regulation 298/12 "Collection of Pharmaceuticals and Sharps -‐ Responsibilities of Producers" 8

2.1.2 Other Applicable Acts, Regulations, Guidelines and Standards .................................................. 9

3. THE HEALTH PRODUCTS STEWARDSHIP ASSOCIATION ...................................................................... 11

3.1 Vision ................................................................................................................................................ 11

3.2 Mandate ........................................................................................................................................... 11

3.3 Guiding Principles ............................................................................................................................. 11

4. DESIGNATED MATERIAL (SHARPS) ..................................................................................................... 12

4.1 Sharps Product Category and the Ontario Marketplace: ................................................................. 12

4.2 Categories of Sharps Waste .............................................................................................................. 12

4.3 Generators of Sharps Waste ............................................................................................................ 13

5.0 PROGRAM DESIGN ............................................................................................................................... 14

5.1 Program Goals ...................................................................................................................................... 14

5.2 Program Requirements for Collection, Transportation and Processing of Sharps ........................... 14

5.2.1 Collection Location Requirements: ........................................................................................... 14

5.2.2 Transportation Requirements: .................................................................................................. 16

5.2.3 Processing Requirements: ......................................................................................................... 16

5.3 Program Efficiencies ......................................................................................................................... 17

5.3.1 Waste Reduction Strategies ...................................................................................................... 17

5.3.2 Cost Reduction Strategies ......................................................................................................... 17

5.4 Accessibility ...................................................................................................................................... 18

5.5 Promotion and Education ................................................................................................................. 18

5.5.1 Consumer Outreach Strategy .................................................................................................... 19

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5.5.2 Collection Location Outreach Strategy ...................................................................................... 19

5.5.3 Municipal Outreach Strategy ..................................................................................................... 19

5.6 Financial Resources Summary .......................................................................................................... 20

5.7 Program Cost Elements and Fee Setting Methodology .................................................................... 20

5.8 Program Performance ...................................................................................................................... 21

5.8.1 Collection Opportunity .............................................................................................................. 21

5.9 Auditing and Reporting .................................................................................................................... 22

5.9.1 Auditing ..................................................................................................................................... 22

5.9.2 Reporting ................................................................................................................................... 22

5.9.3 Key Milestones .......................................................................................................................... 23

APPENDIX A: SHARPS PRODUCERS ............................................................................................................ 24

APPENDIX B: COLLECTION LOCATION AGREEMENT .................................................................................. 25

APPENDIX C: REGULATION 298/12 ............................................................................................................ 29

APPENDIX D: PHARMACY INSTRUCTIONS FOR SHARPS DISPOSAL ............................................................ 40

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1. GLOSSARY OF KEY DEFINITIONS AND ACRONYMS

1.1 Acronyms AMO: Association of Municipalities of Ontario CACDS: Canadian Association of Chain Drug Stores CAP: Canada-‐Wide Action Plan for EPR CAPDM: Canadian Association for Pharmacy Distribution Management CCME: Canadian Council for Ministers of the Environment CSA: Canadian Standards Association ECA: Environmental Compliance Approval EPA: Ontario Environmental Protection Act EPR: Extended Producer Responsibility HHW: Household Hazardous Waste RCO: Recycling Council of Ontario HPSA: Health Products Stewardship Association IFO: Industry Funding Organization ISP: Industry Stewardship Plan MHSW: Municipal Hazardous or Special Waste MOE: Ontario Ministry of the Environment MWA: Ontario Municipal Waste Association OCP: Ontario College of Pharmacists OCR: Operating Contingency Review OECD: Organization for Economic Co-‐operation and Development OPA: Ontario Pharmacists’ Association OSCP: Ontario Sharps Collection Program PCPSA: Post-‐Consumer Pharmaceutical Stewardship Association RCC: Retail Council of Canada RCO: Recycling Council of Ontario WDA: Waste Diversion Act WDO: Waste Diversion Ontario

1.2 Terms and Definitions

a) Biomedical Waste: Biomedical Waste can be defined as human anatomical waste, human blood waste, animal anatomical waste, animal blood waste, microbiology laboratory waste, sharps waste, cytotoxic waste, waste that has come into contact with human blood that is infected or suspected of being infected with any infectious substance (human), and a waste containing or derived from one of more of the above wastes.

b) Collection Location(s): A location, typically a retail pharmacy, at which the collection of one or both of pharmaceuticals and sharps is provided for.

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c) Consumer: Means an individual acting for personal, family or household purposes, including acting in respect of a companion animal.

d) Cytotoxic Waste: Means a cytotoxic drug, a medicinal chemical or a waste containing a cytotoxic drug or medicinal chemical, including waste needles.

e) Household Hazardous Waste Facilities:

Temporary and permanent locations operated by municipalities in Ontario where consumers can drop off used sharps and other hazardous waste from households for transfer and end-‐of life processing.

f) Producer: The manufacturer of a medication (prescriptions, natural health products or non-‐prescription drugs) or a product that becomes a sharps waste, if:

i) it is sold to consumers in Ontario under a brand name that the manufacturer owns, licenses or has rights to;

ii) or is the owner of or licensee of the brand or rights holder under which the medication or sharp is sold to consumers in Ontario;

iii) or the importer of the medication or sharps into Ontario.

g) Program Plan: A document that provides producers with a strategy for individually or collectively managing the extended producer responsibility of their products including any safety, environmental and regulatory requirements.

h) Sharp (Designated Material): Under Regulation 298/12 a sharp is defined as a needle, safety engineered needle, lancet or other similar instrument that is designed to puncture the skin of individuals or companion animals for medical purposes and that is sold to consumers in Ontario, whether it is sold by the producer of the sharps or another person, and includes anything affixed to the sharp, including a syringe. Additionally, for the purposes of the OSCP, sharps as a designated material are further defined as,

a. Infusion sets with needles attached. b. Lancets, including safety lancets. c. Needle tips. d. Needles, including safety needles. e. Pen only with needle attached. f. Pen needles. g. Prefilled cartridges only with needles attached. h. Pre-‐filled syringes only with needles attached.

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i. Safety pens only with needles attached. j. Syringes only with needles attached.

i) Sharps Container:

A colored coded, puncture, break and leak resistant container designed for containing used sharps that is labeled with fill line, a universal biohazard symbol and/or cytotoxic symbol.

j) Steri-‐Pack: Compliant packaging used for the OSCP consisting of a corrugated cardboard biomedical waste box, plastic liner and sharps containers that is provided to participating collection locations for the safe, compliant containment, collection and transportation of used sharps.

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2. INTRODUCTION The Organization for Economic Co-‐operation and Development (OECD) has defined EPR as "a policy approach in which a producer's responsibility, physical or financial, for a product is extended to the post-‐consumer stage of a product's lifecycle". The purpose of this document is to provide a plan for the management of EPR for post-‐consumer sharps in Ontario. The primary objective of this document is to ensure, through a detailed program plan, that HPSA member sharps producers meet the principles of EPR and are in compliance with Regulation 298/12 "Collection of Pharmaceuticals and Sharps -‐ Responsibilities of Producers" under the Ontario EPA.

2.1 Regulatory Review The OSCP is a regulatory driven EPR initiative. The following regulatory review examines the acts, regulations, guidelines and standards that are relevant to the OSCP.

2.1.1 Regulation 298/12 "Collection of Pharmaceuticals and Sharps -‐ Responsibilities of Producers" The compliance requirements of the OSCP are dictated primarily by Regulation 298/12. This regulation requires producers of pharmaceuticals and sharps to provide for the collection and safe environmental management of their leftover products from consumers. Producers must also provide Ontarians with access to free and convenient collection locations, such as retail pharmacies, to return their leftover pharmaceuticals and sharps. The Regulation defines “Sharps” as:

A needle, safety engineered needle, lancet or other similar instrument that is designed to puncture the skin of individuals or companion animals for medical purposes and that is sold to consumers in Ontario, whether it is sold by the producer of the sharps or another person, and includes anything affixed to the sharp, including a syringe.

The Regulation defines “Producers” as:

a) the manufacturer of the pharmaceutical or sharp, if it is sold to consumers in Ontario under a brand that the manufacturer owns, licenses or otherwise has rights to;

b) if there is no person described in clause (a), the owner or licensee of the brand or the person who otherwise has rights to the brand under which the pharmaceutical or sharp is sold to consumers in Ontario;

c) if there is no person described in clause (a) or (b), the importer of the pharmaceutical or sharp into Ontario; or

d) if there is no person described in clause (a), (b) or (c), the first person who sells the pharmaceutical or sharp to another person in Ontario.

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The regulation requires producers to demonstrate participation in an approved program in order to do business in Ontario. HPSA is the industry designated IFO that has developed compliance protocols to ensure a level playing field among brand-‐owners selling sharps in Ontario. Producers deemed to be non-‐compliant with program requirements are subject to enforcement under the EPA which is the responsibility of the government of Ontario.

2.1.2 Other Applicable Acts, Regulations, Guidelines and Standards The list of additional acts, regulations, guidelines and standards that have been considered in the creation of the program plan for the OSCP is as follows:

a) Canadian Council for Ministers of the Environment (CCME) Canada-‐Wide Action Plan on EPR (CAP)

The CCME CAP for EPR is a guideline for regulatory and EPR program clarity for government, producers and IFOs like HPSA and identifies what CCME understands EPR to mean and what principles can be used to govern its adoption. The CAP contains guidelines on key elements that should be common to all EPR programs in Canada.

b) CSA Z316.6-‐07 “Evaluation of Single-‐Use and Reusable Sharps Containers” The evaluation standards of single-‐use and reusable medical sharps containers for biohazardous and cytotoxic waste are presented in this CSA publication. Under the OSCP, as administered by the HPSA, single-‐use sharps containers are used for the primary containment of biohazardous sharps and cytotoxic sharps that are returned to collection locations by consumers. CSA Z316.6-‐07 outlines the general design, labeling, testing and disposal requirements for single-‐use and reusable sharps containers and is the standard that has been adopted by the supplier of sharps containers to the OSCP.

c) Drug and Pharmacies Regulation Act Among other things, the Drug and Pharmacies Regulation Act of Ontario defines what a pharmacy is and how it is accredited. Under Regulation 298/12 producers are obligated to initially have a minimum 80% of accredited pharmacies or 80% of retail locations in Ontario in which pharmaceuticals or sharps were sold acting as collection locations. This threshold increases to 90% effective January 1, 2014.

d) Guideline C-‐4 "The Management of Biomedical Waste in Ontario" Biomedical waste, including sharps waste, is one of the many types of wastes regulated by the Ontario Ministry of the Environment (MOE). This guideline details the MOE's expectations for the management of sharps waste. The guideline applies primarily to generators of biomedical waste; and companies who are responsible for transportation and treatment of the waste. For OSCP collection locations, the containment and labeling requirements for sharps waste are also defined in this guideline. Under Regulation 298/12, collection locations are required to have an agreement with a company that has an Environmental Compliance Approval (ECA) allowing the transportation and treatment of biomedical waste, including sharps. Companies in Ontario that can provide this service have a

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Provisional ECA for a Waste Management System issued by the MOE that has conditions requiring compliance with Guideline C-‐4.

e) Ontario Environmental Protection Act (EPA) This act is Ontario's key legislation for environmental protection. The act grants the MOE broad powers to deal with the discharge of contaminants which cause negative effects. The act specifically: • prohibits the discharge of any contaminants into the environment which cause or are likely to

cause negative effects -‐ and in the case of some approved contaminants requires that they must not exceed approved and regulated limits;

• requires that any spills of pollutants be reported and cleaned up in a timely fashion. Ontario's EPA has the authority to establish liability on the party which is at fault, including liability for corporate officers or directors who have failed to take all reasonable care to prevent unlawful discharges of contaminants into the environment. Regulation 298/12 and Regulation 347 are part of the EPA.

f) Pharmacy Act, 1991 A person registered as a pharmacist or a pharmacy technician under the Pharmacy Act, 1991 must be present when the collection of sharps or pharmaceuticals from the public occurs at a collection location. This is a requirement of Regulation 298/12 in order for the collection Location to be exempt from the collection, handling, storage and transfer requirements of Regulation 347.

g) Regulation 347 "General -‐ Waste Management" Regulation 347 under the EPA provides the detailed rules on how waste streams should be categorized, documented, tracked and handled including biomedical (sharps) and pharmaceutical waste. Regulation 347 identifies hazardous wastes through a series of listings and tests. It also sets standards and requires annual registration of generators of hazardous waste and liquid industrial waste and the payment of a registration fee. Generators of sharps (collection locations) and companies with an ECA for the collection, handling, transportation and processing of sharps are governed under this regulation.

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3. THE HEALTH PRODUCTS STEWARDSHIP ASSOCIATION The HPSA is the IFO created to manage safe disposal of unused or expired health products returned from the public in regulated provincial programs. HPSA's predecessor PCPSA began in 1999 by managing the BC Medications Return Program on behalf of producers as required under British Columbia Recycling Regulation 449/2004. HPSA's producer members represent the majority of brand-‐owners selling health products in Canada. The list of sharps producers that are members of the HPSA and are participating in the OSCP is attached in Appendix A.

3.1 Vision The vision of the HPSA is to be the recognized IFO for environmental waste management programs of health-‐related products.

3.2 Mandate The mandate of the HPSA is to collect and dispose of sharps and medications returned by the public in a cost-‐efficient and environmentally acceptable manner that meets government policy and/or regulatory requirements for its producer members.

3.3 Guiding Principles 1. Level Playing Field: Provide a level playing field (fair competition), achieve a high level of

compliance, and reduce the potential for having producers fail to meet their financial obligations. 2. Environmental Standards: Ensure materials are disposed of in a responsible manner that safeguards

the environment and worker health and safety in accordance with regulatory requirements. 3. No Cross-‐Subsidization: Ensure the collection of revenue from the program is in balance with the

expenses for the program with fees closely reflecting the costs of managing each obligated product. 4. Operational Efficiencies: Ensure the program is delivered effectively and efficiently at the lowest

possible cost. 5. Business Sustainability: Ensure sustainable management of the association by maintaining an

appropriate operating contingency reserve (OCR), but not accumulating a surplus. 6. Continuous Improvement: Adhere to provisions for best practices to strive for continuous

improvement in environmental and economic performance. 7. Harmonization: To the greatest extent possible, harmonize with other programs to achieve

economies of scale.

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4. DESIGNATED MATERIAL (SHARPS) A fundamental component of the program plan is the definition of sharps that consumers can return as part of the OSCP. For the purposes of the OSCP sharps, as a designated material, are defined as,

a. Infusion sets with needles attached. b. Lancets, including safety lancets. c. Needle tips. d. Needles, including safety needles. e. Pen only with needle attached. f. Pen needles. g. Prefilled cartridges only with needles attached. h. Pre-‐filled syringes only with needles attached. i. Safety pens only with needles attached. j. Syringes only with needles attached.

A sharp does not include the following:

a. Biomedical waste other than sharps. b. Expired samples. c. Prefilled pen/cartridges without the needle. d. Vial/ ampoules.

4.1 Sharps Product Category and the Ontario Marketplace: The definition of a producer under Regulation 298/12 is referenced in section 1.2 (f) of the program plan. In the Province of Ontario the following sharps producer distribution scenarios exist:

• Manufacturers selling their brand to wholesalers and retail pharmacies; • Retail pharmacies selling their private label branded sharps to consumers; • First importers selling sharps to wholesalers and retail pharmacies.

4.2 Categories of Sharps Waste Post-‐consumer sharps waste collected in the OSCP fall into two categories; biomedical sharps and cytotoxic sharps. Biomedical sharps are sharps products used by consumers that are designed to puncture the skin for medical purposes. Used biomedical sharps must be properly placed in an approved sharps container, colour coded yellow with a universal biohazard symbol on the outside, for primary containment purposes in order to be accepted at collection locations. Cytotoxic sharps are sharps products used by consumers for a chemotherapeutic application. Used cytotoxic sharps must be placed in an approved sharps container, colour coded or labeled red and must

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have a cytotoxic symbol on the outside, for primary containment purposes in order to be accepted at collection locations.

4.3 Generators of Sharps Waste Under the OSCP sharps waste is brought to collection locations in approved sharps containers by consumers. Regulation 298/12 requires the number of collection locations in the Province of Ontario to be equal to 80% of retail locations at which a pharmaceutical or sharp was sold or 80% of accredited pharmacies in Ontario as of October 1st of the preceding calendar year, whichever is less. On January 1st, 2014 the threshold for collection locations increases to 90%. As of March 31st, 2013 there were 2,962 collection locations registered and active in the OSCP. Some municipalities accept sharps waste from consumers at municipally operated HHW facilities which are not part of the OSCP administered by the HPSA. Under the MOE Selected Household Hazardous Waste Initiative, the Government of Ontario has provided up to $3.5 million for a three year program to reimburse eligible municipal costs to properly manage certain household hazardous wastes including sharps and pharmaceuticals. The Recycling Council of Ontario (RCO) is contracted to manage the fund that pays participating municipalities eligible costs associated with the management of their selected Phase 2 waste under the Municipal Hazardous or Special Waste (MHSW) Program, including sharps. Current waste management service provider data indicates that approximately 50 municipalities in Ontario accept sharps waste from residents at HHW facilities.

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5.0 PROGRAM DESIGN The OSCP provides all Ontario residents with reasonable access to collection locations on a province-‐wide basis. HPSA is responsible for strategic planning, overseeing the program and financial operations including the placement of a local program administrator to managing day-‐to-‐day operations of the program. A program plan designed to address Regulation 298/12 must provide for the following:

1. The appropriate management of waste material according to the guideline established by the Minister;

2. A province-‐wide, convenient collection system for waste material without user fees at the point of collection;

3. A collection system equal to 80% of retail locations in Ontario; 4. The establishment and administration of promotion and educational material for the program; 5. Interim/annual reports.

5.1 Program Goals The goals of the program are to:

• Establish a province-‐wide industry run program for sharps in compliance with Regulation 298/12.

• Provide a plan for collecting post-‐consumer sharps. • Ensure that the producers or stewards who sell, offer for sale or distribute sharps in Ontario

under their own brand name, sponsor their portion of the costs of a sharps return program. • Ensure environmentally responsible disposal of sharps. • Ensure that the public is able to return sharps for disposal throughout the province. • Provide the public with information about collection locations. • Harmonize the plan with other provincial programs.

5.2 Program Requirements for Collection, Transportation and Processing of Sharps

5.2.1 Collection Location Requirements: Retail pharmacies participating in the OSCP must have a registered pharmacist or registered pharmacy technician that is trained on how to receive, handle and package sharps waste returned to the pharmacy by consumers. Biomedical sharps are sharps products used by consumers that are designed to puncture the skin for medical purposes and must be properly placed in an approved sharps container, colour coded yellow with a universal biohazard symbol on the outside, with a lid that is sealed shut in order to be accepted at collection locations. At the pharmacy the sharps containers must then be placed into approved secondary containment packaging in the form of a corrugated cardboard box with the

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universal biohazard symbol on the outside and lined with a 2 mil plastic bag. Once the full sharps containers are placed into the lined box it is sealed shut and ready for transportation and disposal. When a prescription is filled for a cytotoxic medication that has a sharp, the lead practice is to provide a new sharps container with a cytotoxic label to the customer at the same time. Cytotoxic sharps are sharps products used by consumers for a chemotherapeutic application and must be placed in an approved sharps container, colour coded or labeled red with the cytotoxic symbol on the outside and a lid that is sealed shut in order to be accepted at collection locations. These containers must then be placed into approved secondary containment packaging in the form of a corrugated cardboard box with the universal biohazard symbol on the outside and a cytotoxic label prominently displayed on the outside of the box. The box should have a 2 mil plastic liner. Once the full sharps containers are placed into the lined box it is sealed shut and ready for transportation and disposal. Since the voluntary participation of a pharmacist or pharmacy technician is central to the success of the program, HPSA works closely with these stakeholders to ensure full participation and awareness of the OSCP. Pharmacy managers interested in offering the program in their store must complete a registration form. Specific information is provided to ensure that pharmacy managers and staff are knowledgeable on the program objective and the way the program operates. All participating collection locations receive a kit containing instructions on the program, a service request form, and sample of education material developed for this program along with a Steri-‐pack. Once the registration form is completed and submitted to HPSA, the pharmacist is contacted directly by HPSA to review the following information:

• Sharps from hospitals, institutions, doctor’s offices or internal pharmacy operations are not

acceptable. • Key employees working at the collection location must be knowledgeable about the program

offered to consumers. • The pharmacy shall only receive sharps in a hard-‐shell container (approved sharps container)

which is labelled with the universal biohazard symbol. • Sharps containers must be segregated from waste pharmaceuticals. • Sharps approved containers are placed in a cardboard box with an approved liner. • Sharps used to administer cytotoxic drugs shall be deposited into a sharps container and labelled

with a cytotoxic label. • The pharmacist or pharmacy technician will inform sharps user on the proper disposal of needles. • Upon receiving sharps containers, pharmacists should ensure that tops of the containers are

securely closed and placed face down in the Steri-‐pack (see instructions in Appendix D). Once a Steri-‐pack is full, the pharmacist must complete the service request form and contact the waste management service provider to schedule service. Replacement containers will be delivered and the full container will be picked up either on scheduled service or by request. Collection locations must also meet the following requirements:

• At a minimum, 80% of all retail locations in Ontario where a sharp is sold or 80% of all accredited pharmacies must participate in the OSCP.

• There must be at least one collection location in each municipality in Ontario where there is a retail pharmacy that sells sharps.

• Collection locations must provide the service of collecting sharps from consumers at no charge.

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• There is no limitation on the quantity of sharps that a consumer can drop off at a collection location.

• The collection location must provide the consumer the ability to drop off sharps during regular business hours.

• A registered pharmacist or pharmacy technician must be present when a consumer drops off used sharps.

• There must be an agreement in place between the collection location and an approved waste management service provider that addresses the types of containers that are to be used for the collection, handling, storage and labeling of sharps. The agreement must also stipulate how sharps containers are to be collected, handled and stored at the collection location.

• Under the agreement between the collection location and the waste management service provider, pharmacists and pharmacy technicians that are handling sharps must receive annual training on the safe collection, handling and storage of sharps and on the other requirements of the agreement. An example of an agreement between a collection location participating in the OSCP and a waste management service provider is attached in Appendix B.

• A copy of the agreement and any related records must be kept on site at all times while the collection location is participating in the OSCP and for five years afterward.

• At each participating collection location there must be a complete list of all collection locations in Ontario where sharps can be delivered by the consumer and information available describing how consumers should safely store and handle sharps before bringing them to a collection location.

If the location is offering collection of sharps under the OSCP and it is not a retail pharmacy then the location has to be approved by the HPSA and has to meet the full requirements of Regulation 347 of the EPA before participation in the program can begin.

5.2.2 Transportation Requirements:

• The waste management service provider must have an ECA (a Provisional Certificate of Approval for a Waste Management System) issued by the Ontario MOE.

• The ECA has to allow for the transportation of 312P biomedical waste, a waste class defined under Regulation 347.

• All conditions of the ECA must be adhered to by the waste management service provider when transporting sharps waste (i.e.: general requirements, transportation and vehicle standards, public waste requirements, staff training, record keeping, reporting and financial assurance).

• The waste management service provider must provide annual training to pharmacists and pharmacy technicians at the collection location on the safe collection, handling and storage of sharps.

5.2.3 Processing Requirements:

• The waste management service provider must have an ECA (a Provisional Certificate of Approval for a Waste Disposal Site) issued by the Ontario MOE that allows for the processing of 312P biomedical waste by steam sterilization or by incineration.

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• Biomedical sharps must be treated using a high pressure steam sterilization process (typically a commercial autoclave).

• Cytotoxic sharps must be treated by high temperature incineration. • A waste-‐to-‐energy facility permitted to handle municipal solid waste is the preferred post

processing treatment method for sharps waste that has been rendered non-‐infectious (classified as treated medical waste).

• The bottom ash from the incineration of cytotoxic sharps must be disposed in a landfill approved to receive this waste stream.

5.3 Program Efficiencies

5.3.1 Waste Reduction Strategies As a designated material, sharps have unique characteristics that other designated materials do not. For example:

• Sharps are used as a delivery device in a healthcare related application. • They are used only once and then discarded. • Because of contact with human or animal tissue, sharps are potentially infectious and are

considered a biomedical waste. • Some sharps are used to inject drugs with chemotherapeutic properties and are therefore

considered more hazardous than biomedical sharps. These sharps are classified as a cytotoxic waste. In the OSCP cytotoxic sharps make up approximately 4% of the sharps waste stream.

There are no readily available options to reduce the waste generated when using a sharp related product. Due to the unique hazards associated with sharps waste, reuse or recycling is typically not an option. Some efforts have been made to recycle the sharps waste stream once it has been treated and rendered non-‐infectious. In the United States, Becton Dickinson and Company formed an alliance with Waste Management to recycle sharps waste from hospitals and other healthcare facilities. Their ecoFinity Life Cycle Solution program claims to recycle the plastic and metal from the sharps waste stream and use the plastic to make new collection containers. The program is not available in Ontario and is not designed for EPR (post-‐consumer) sharps related waste streams. The material management objective for sharps collected in the OSCP is safe, secure, compliant and environmentally responsible disposal.

5.3.2 Cost Reduction Strategies HPSA assumed responsibility for the stewardship of post-‐consumer sharps in Ontario in October 2012 when Stewardship Ontario's administration of a sharps program under Phase 2 of the Municipal Hazardous or Special Waste (MHSW) Program (branded as Orange Drop) ended. As the new IFO administering the sharps program, HPSA continually strives for cost efficiency opportunities for the OSCP. Recently identified opportunities include:

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a) Primary (sharps containers) and secondary (boxes and liners) packaging for sharps represents

the majority of the total cost of the program. As part of HPSA's service agreement, the current waste management service provider has the ability to provide smaller sharps containers into the OSCP. The standard sharps container currently used is 4.5L. In some instances it takes the consumer a significant amount of time to fill the sharps container (e.g.: pen needles for injecting insulin) so they may not fill it up (to the fill line identified on the container) before returning it to a collection location. Consumers are more likely to fill a smaller container (e.g.: 1.4L) before returning it which would then allow collection locations to achieve better density (more weight) when they consolidate sharps containers for transportation and disposal by the waste management service provider. The end result is that fewer sharps containers will be used and consolidated boxes of used sharps will be heavier which will drive down HPSA's overall purchasing and disposal costs for the program.

b) HPSA will be working directly with industry associations, the OSCP waste management service

provider and retail collection sites to minimize abuse of the program. Only legitimate, consumer facing collection locations can accept sharps waste from the public under the structure of the OSCP. For example, hospital pharmacies, commercial pharmacies serving only institutions, and retail pharmacies accepting waste from healthcare professionals (doctors, dentists, etc.) are not eligible to participate in the OSCP. HPSA will be monitoring potential program abuse through collection location data analysis, vendor support and random inspections at collection site locations. This will help remove ineligible sharps waste from the program and drive down overall costs.

5.4 Accessibility As of March 31st, 2013 a total of 2,962 retail pharmacies were registered and active as collection locations under the OSCP of the 3,524 retail pharmacies in Ontario that are eligible to participate in the program. This puts the participation rate at 84% which is above the 80% required by Regulation 298/12 and ensures excellent program access across Ontario for consumers to dispose of their sharps waste. The administration of the OSCP is new to HPSA but it is a mature EPR program with high collection location penetration. Through the extensive communication, promotion and education program detailed in below, HPSA will work toward the goal of increasing the rate of collection location participation to 90% or more by October 1, 2013, as required under Regulation 298/12.

5.5 Promotion and Education When Stewardship Ontario launched a sharps return program in July 2010 as part of the Phase 2, MHSW "Orange Drop" program there was an initial promotion campaign comprised of a website, press releases, media campaign and a welcome pack that was sent to all retail pharmacies in Ontario. Promotion and education of the program by Stewardship Ontario ended when the Minister of Environment cancelled the Phase 2 and Phase 3 of the MHSW program. HPSA will be launching a promotion and education strategy to consumers and to collection locations about the OSCP. The strategy will have the following components:

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5.5.1 Consumer Outreach Strategy

• A new brochure will announce that HPSA is administering the OSCP on behalf of producers and explain to consumers how the program works. It will include a description of how consumers can get sharps containers at no charge under the program and how they should safely handle and store used sharps before bringing them to participating collection locations. A print version of the brochure will be available to consumers at all participating collection locations and will also be available in electronic format on the HPSA website.

• Consumers can find other OSCP details on the website as well as the location of the nearest collection location.

• HPSA will work with producer members to have them establish a link from their website to the OSCP information on HPSA's website to further promote program awareness to consumers and ensure producers comply with this requirement of Regulation 298/12.

5.5.2 Collection Location Outreach Strategy

• Outreach/education packages for collection locations will clearly explain the HPSA industry-‐run program, timelines, the inclusion of sharps as a designated material and expectations for participating collection locations.

• A list of all collection locations that are receiving sharps will be sent each collection location annually by HPSA.

• The brochure and the collection location education packages will be sent to each collection location and can be ordered by collection locations by calling HPSA or going to the HPSA website.

• A communication piece will announce the arrival of the new program resources for the OSCP and will be sent to collection locations in the form of a letter to chain pharmacy headquarters, a fax blast to retail pharmacies and an insert included in the collection containers (Steri-‐packs) distributed by the waste management service provider.

• HPSA will engage the Retail Council of Canada (RCC), the Ontario Pharmacists’ Association (OPA), the Canadian Association of Chain Drug Stores (CACDS), the Ontario College of Pharmacies (OCP), and the Canadian Association for Pharmacy Distribution Management (CAPDM) to promote the HPSA program through their networks and outreach channels (i.e., industry newsletters, events and websites).

5.5.3 Municipal Outreach Strategy Currently consumers return used sharps to municipally operated HHW facilities. The OSCP has the proper checks and balances in place with a specialized network of collection locations staffed by pharmacists and pharmacy technicians trained in the handling of sharps waste. HPSA has also contracted Stericycle, ULC., a transportation and disposal service provider specializing in biomedical waste, to properly manage the health and environmental risk associated with used sharps. For these reasons, HPSA will work with RCO, AMO (Association of Municipalities of Ontario) and the MWA (Municipal Waste Association) to adopt a strategy of providing information to consumers to

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encourage them to return sharps to the closest participating collection location registered in the OSCP rather than bringing them to HHW facilities.

5.6 Financial Resources Summary HPSA is the IFO responsible for the OSCP. HPSA staff administers the program and its various components including the contract with Stericycle, ULC. for the provision of sharps packaging, transportation and disposal. Funding from the industry covers expenses incurred in the collection, transportation, storage, disposal, promotion activities and education in connection with the OSCP. The cost of program administration, promotion and educational activities and the logistics of managing sharps waste are paid for entirely by industry (HPSA member sharps producers are listed in Appendix A). To provide sufficient revenue for the ongoing operation of the program, HPSA members with products meeting the material definition of sharps will be invoiced by HPSA according to the weight associated with volume of sales (units) during the previous calendar year (January-‐December). There is no visible user fee (eco fee) directed to the consumer at the point of purchase of sharps products or at the point of collection.

5.7 Program Cost Elements and Fee Setting Methodology In determining the fee setting methodology for the OSCP it should be noted that the primary considerations are:

• Unit sales (purchased by retail pharmacies) are known. • Disposal weights of products are known or can be measured. • There is no sorting at collection locations and all returned sharps products are handled in the

same manner with no opportunity for an end market commodity value to be obtained. • Collection and processing system costs are weight-‐based. • Historical data on which to base estimates is readily available. • Overall stewardship costs do not vary based on sharps product type.

Given that the costs of operating the collection, transportation and disposal system for sharps are weight-‐based, with no differential in net costs for any device, the funding formula for the program is weight based. Sharps producers report unit sales and the disposal weight for each unit. Both the unit sales and disposal weights provided by the producer and are subject to validation if deemed necessary by HPSA. The actual cost per kilogram to the producer for sharps products is set yearly by the HPSA board of directors.

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5.8 Program Performance The key program performance related metric is the regulatory requirement for HPSA is to have 80% of retail pharmacies in Ontario registered as collection locations as of October 1, 2012 under section 4 of Regulation 298/12, a target which has already been achieved. The performance metric requirement increases to 90% as of October 1, 2013.

5.8.1 Collection Opportunity The theoretical sharps waste collection opportunity for the OSCP is the aggregate weight of all the sharps sold into the Ontario market for consumer use by producers in a calendar year. To calculate this potential opportunity the following annualized data is required:

a) Unit volume of all sharps product sold into the Ontario market for consumer use. b) The weight of each unit of sharp product sold into the Ontario market for consumer use.

a * b = c (total annual sharps products collection opportunity by weight)

c) The total annual sharps products collection opportunity by weight

To calculate what percentage of total collection opportunity is being captured by the OSCP the following annualized data is required:

d) The total weight of all material (sharps, sharps containers, packaging) collected in the program. e) The total weight of material collected in the program that can be attributed to the sharps

containers purchased by HPSA for use in the program. f) The total weight of material collected in the program that can be attributed to secondary

packaging (boxes, liners) used to package the returned sharps containers.

d – (e + f) = g (total sharps products (only) collected by weight)

g) The total weight of sharps products (only) collected.

g / c = h (% of the total annual weight of sharps products sold that is captured by the OSCP)

h) The % of the total annual weight of sharps products sold that is captured by the OSCP.

HPSA will be in position to calculate the collection opportunity and the % of sharps collected once annualized data has been accumulated. Because administration of the OSCP commenced on October 1, 2012 data for points a) and b) above have yet to be annualized. Data for points d), e) and f) are supplied to HPSA by the waste management service provider.

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5.9 Auditing and Reporting

5.9.1 Auditing Due to the infectious and/or chemotherapeutic nature of post-‐consumer sharps waste collected in the OSCP, the potential health and safety hazard prohibits the ability of HPSA to physically audit the sharps waste stream to gather specific data on the different types of sharps products or to monitor levels of contamination of other types of waste.

5.9.2 Reporting The two reporting requirements that HPSA will provide on behalf of its member sharps producers are clearly defined in Regulation 298/12. An interim report on the OSCP must be prepared by HPSA for the period of October 1, 2012 to March 31, 2013 and an annual report must be prepared each year thereafter.

a) Interim Report A one-‐time interim report on the OSCP must be prepared by HPSA on behalf of member sharps producers covering the period of October 12, 2012 to March 31, 2013. The interim report has to meet the following minimum requirements:

• The name of all sharps producers on whose behalf the HPSA prepared the report must be listed; • A description of the actions taken and outcomes achieved to demonstrate compliance with the

regulation by HPSA on behalf of the producers; • The total number and address of each collection location where sharps are collected on behalf

of producers; • The interim report must be posted at the HPSA website ( www.healthsteward.ca ) for a period

of one year.

b) Annual Report Following the interim reporting period above, an annual report on the OSCP must be prepared by HPSA on behalf of member sharps producers. The annual report has to meet the following minimum requirements:

• The name of all sharps producers on whose behalf the HPSA prepared the report must be listed; • The total number and address of each collection location where sharps are collected on behalf

of producers and any change in the number and location of collection locations from the previous calendar year;

• The total weight of all sharps received at collection locations for the previous year; • The total weight of sharps containers gathered at collection locations for the previous year;

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• A description of how sharps generated by collection locations was handled and disposed of during the previous calendar year;

• A description of the actions taken by HPSA to ensure compliance with the requirements for collection and disposal of sharps and sharps containers returned by consumers to collection locations;

• Documentation from HPSA that at least 80% of retail pharmacies are participating in the OSCP and that there is at least one collection location in every municipality where sharps are sold;

• Documentation from HPSA that collection locations participating in the OSCP provide the service free of charge to consumers, set no limitations on the quantity of sharps containers that can be returned by consumers and have the service available to consumers during the hours of operation for the pharmacy;

• Documentation from HPSA that each collection location received a printed list of collection locations participating in the OSCP;

• An example of an educational brochure explaining how consumers safely handle and store sharps waste before bringing it to a collection location;

• Documentation from HPSA that all participating collection locations are listed on the HPSA website;

• Documentation from HPSA that a printed version of the educational brochure was provided to participating collection locations;

• An opinion from a licensed public accountant confirming the accuracy of the reported number and address of participating collection locations and any change that occurred in collection locations from the previous calendar year;

• The annual report must be ready for release on or before April 1st each year; • The annual report must be posted at the HPSA website for a period of three years.

5.9.3 Key Milestones

Milestone Completion Date OSCP Resource Development (Public and Retail Pharmacy Education) June 14, 2013 Communication Launch and Follow Up to Stakeholders July 19, 2013 Publish Interim Report June 30, 2013 Reach 90% Retail Pharmacy Participation Rate October 1, 2013 Publish Annual Report for 2013 April 1, 2014

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APPENDIX A: SHARPS PRODUCERS

Abbott Laboratories Amgen Canada Inc. AstraZeneca Auto Control Medical Baxter Canada Bayer Becton Dickenson Biogen Idec Canada Inc. Bristol Myers Squibb Canada Co. Covidien Kendall Domrex Pharma Inc. Eli Lilly Canada Inc. EMD-‐Serono Canada Inc. Ferring Inc. GlaxoSmithKline Hospira Intervet Canada Corp (a Merck Company) Janssen Inc. Leo Pharma Inc. Lifescan Medtronic Merck Canada Inc. Novartis Pharma Canada Inc. Novo Nordisk Paladin Labs Inc. Pfizer (Wyeth) Pharmascience Roche Diabetes Care Sandoz, Inc. Sanofi-‐Aventis Schering-‐Plough Canada Inc. Smiths Medical Stericycle, ULC. Teva Canada Valeant Canada LP Wal-‐Mart

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APPENDIX B: COLLECTION LOCATION AGREEMENT

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APPENDIX C: REGULATION 298/12

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APPENDIX D: PHARMACY INSTRUCTIONS FOR SHARPS DISPOSAL

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