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1

Ontario Medications Return Program

Ontario Sharps Collection Program

Annual Report

for the period of

January 1, 2021 - December 31, 2021

Submitted to:

Charles O

'Hara

Resource Recovery Policy Branch

Environmental Policy Division

Ministry of the

Environment Conservation and Parks

Prepared by:

Terri Drover

Director

General

Health Products Stewardship Association

March 31,

2022
2

Table of Contents

Definitions 3

Executive Summary 5

I. 2021 HPSA Members 6

II. 2021 Collection Locations 6

III. Overview of the Collection and Disposal Process 8

IV. 2021 Collections 9

A. Pharmaceuticals 9

Table 1

Program Performance - Report on Collection of Pharmaceuticals by

Quarter

9

B. Medical Sharps 10

Table 2

Program Performance - Report on Collection of Medical Sharps by

Quarter

11

V. Public Education Materials and Campaigns 11

A. Provincial and National Campaigns 11

B. Website and Ongoing Social Media 14

C. Collection Locations 16

VI. Auditor's Report 17

Appendix 1

- HPSA Members - OMRP 18

Appendix 2

- HPSA Members - OSCP 20

Appendix 3

- Auditor's Report (Opinion from a Licensed Public Accountant) 21

Appendix 4

- Samples of HPSA Materials 24

Appendix 5

- Producer Member Websites 25

Appendix 6

- List of Registered Pharmacies with OMRP & OSCP 29 3

Definitions

The following terminology is used throughout the document. Collection Sites Community pharmacies registered in the HPSA programs to collect unused and/or expired Pharmaceuticals and used

Medical Sharps

returned from the public. Pharmaceuticals Products sold directly to consumers and includes:

Prescription drugs

Non-prescription drugs

Natural health products

Member Brand-owner/steward/producer who is a member of the Health Products

Stewardship Association (HPSA).

Medical Sharps Ont. Reg. 298/12 - "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 sharp or by any another person, and includes anything affixed to the sharp, including a syringe" For the purpose of the Ontario Sharps Collection Program (OSCP) Plan, a medical sharp shall be generally 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. Prefilled syringes only with needles attached. i. Safety pens only with needles attached. j. Syringes only with needles attached. Natural Health Products Under the Natural Health Products Regulations, Natural Health Products (NHPs) are defined as:

Vitamins and minerals

Herbal remedies

Homeopathic medicines

Traditional medicines such as traditional Chinese medicines

Probiotics

Other products like amino acids and essential fatty acids NHPs must be safe to use as over-the-counter products and do not need a prescription to be sold. Non-Prescription Drugs Nonprescription drugs do not require a prescription of a practitioner under Section C.01.040.03 of the Food and Drugs Regulations in order to be sold and are not listed in the Prescription Drug List established under

Section 29.1 of the Food and Drugs Act.

Examples include:

1) A drug available from a pharmacist but does not require a

prescription. These are the drugs located "behind the counter" 4 where there is no public access and no opportunity for patient self- selection or

2) A drug which does not require a prescription and is available for self-

selection from the area of the pharmacy under the direct supervision of the pharmacist or

3) A drug that may be purchased from any retail outlet (such as a

grocery store)

OMRP Ontario Medications Return Program

OSCP Ontario Sharps Collection Program

Prescription Drugs A drug requiring a prescription for sale in Canada Regulation Collection of Pharmaceuticals and Sharps - Responsibilities of Producers - 298/12 - Environmental Protection Act Producer Means a brand owner or first importer under HPSA membership criteria 5

Executive Summary

Since 2013, the Health Products Stewardship Association (HPSA) has been administering the Ontario Medications Return Program (OMRP) for Pharmaceuticals (prescriptions drugs, non-prescription drugs

and natural health products) as well as the Ontario Sharps Collection Program (OSCP) for Medical Sharps

that are sold in the province of Ontario through the "consumer/residential" waste stream. These programs operate in accordance with the principles defined by Ontario Regulation 298/12

Collection of Pharmaceuticals and Sharps - Responsibilities of Producers, which is Ontario's first and only

Extended Producer Responsibility regulation created under the Environmental Protection Act (EPA). The OMRP and OSCP programs' design ensures that any unused and/or expired Pharmaceuticals and used Medical Sharps returned by the public can be properly collected, packaged, handled, transported, and

disposed of in a safe, compliant, and environmentally responsible manner. The programs are accessible

to consumers in all municipalities across Ontario; in 2021, the network of collection sites represented

93.62% of all accredited pharmacies.

Compared to 2020, the collected weight of medications and medical sharps increased in 2021, partially

due to lifting pandemic restrictions. Collected pharmaceuticals has increased by 10.9% compared to 2020, medical sharps by 32.3%.

The 2021 annual report also reviews the consumer knowledge survey on the safe disposal of medications

and medical sharps and communications strategy for building consumer knowledge and HPSA brand. HPSA acknowledges the tremendous support of the pharmacy community in the OMRP and OSCP programs and is grateful for the pharmacies' important role in protecting the environment and health of

Ontarians.

6

I. 2021 HPSA Members

Section 9 (2) 1 - The name of each producer on whose behalf the report is prepared. The list of producers/members for Pharmaceuticals is attached in Appendix 1. The list of producers/members for Medical Sharps is attached in Appendix 2. Under Regulation 298/12, Producers are required to have a link on their website that takes consumers to the HPSA website where information on the OSCP and OMRP can be found. A list of HPSA producer/member website links can be found in

Appendix 5

II. 2021 Collection Locations

Section 9 (2) 2 - The number of collection locations and the location of each of the collection locations at

which collection of the designated material of the producers was provided for by all of the producers and

a description of any changes that occurred with respect to the number and location of collection locations

from the previous calendar year. The collection sites for both the OMRP and the OSCP are community pharmacies (listed in

Appendix

6). Each HPSA collection site has signed a Collection Location Agreement or CLA detailing procedures for collection, handling and storage of Pharmaceutical s and Medical Sharps received from the public. In accordance with Section 4 of the Regulation, HPSA ensured that the number of collection locations is at minimum equal to 90% of pharmacies in Ontario, as of October 1 in the preceding calendar year. The Ministry of the Environment Conservation and Parks website posted 4,642 as the number of registered pharmacies that were eligible to participate in the OSCP and OMRP. As of December 31, 2021, 4,346 active pharmacy collection locations in Ontario were registered with HPSA and had returned designated material in the last 12 months.

In the previous calendar year, the number of registered and active retail pharmacies participating in

HPSA's stewardship programs was 4,146. 2021 saw an increase of 200 retail pharmacies participating in the HPSA programs versus the previous year.

The participation rate of total eligible collection locations in the combined programs in Ontario was

93.62% at the end of 2021.

In accordance with Section 4 (2), there is at least one HPSA collection location in every municipality in

Ontario.

7

Section 9 (1) 6 - A description of any actions taken by the producer during the previous calendar year that

exceeded the actions required for the purposes of section 4, in order to provide for the collection of the

designated material of the producer.

HPSA contacted, by mail and e-mail, all non-registered eligible retail pharmacies to introduce the OMRP

and the OSCP. HPSA also provided direction as well as information about the programs. HPSA's outreach

is between 5 to 10 pharmacies a day.

Section 4.3 - A producer of a pharmaceutical or sharp shall ensure that at each collection location at

which the producer provides for collection of the designated material of the producer, the collection is

(a) available free of charge to consumers b) not subject to any limitation s with respect to the quantity of the designated material of the producer that a consumer may bring for collection; and

c) if the collection location is in a pharmacy in respect of which a certificate of accreditation is in effect

under section 139 of the Drug and Pharmacies Regulation Act, available during the business hours of the pharmacy. HPSA delivery and pickup services are provided to all registered collection locations and the public at no cost. HPSA take back programs generate extra retail traffic at participating pharmacies. Guidelines are reviewed by pharmacy staff upon registration and HPSA develops specific brochures for pharmacy staff. 8

III. Overview of the Collection and Disposal

Process

Section 9 (1) 4 - A description of how the designated material of the producer collected at collection

locations was handled and how it was disposed of during the previous calendar year. Unused and/or expired Pharmaceuticals collected through the OMRP are packaged in lined, reusable, 60
L pharmaceutical HPSA branded waste containers (MRP containers) at the collection locations.

When ready for shipment, collection locations tie off the container liner, secure the lid to the base

and arrange for shipment. The service provider contracted by HPSA (Stericycle, ULC or ECS Cares) transports the waste to an HPSA approved disposal site where the Pharmaceuticals and any associated packaging are incinerated. Once emptied, the MRP containers are cleaned and inspected for reuse; 2021 saw a lot less breakage of container than previous years (1%). The 300 MRP broken containers were all recycled into plastic pelets. The approved disposal facility is managed by Stericycle, ULC. Used biomedical sharps collected through the OSCP are received from consumers in sharps containers

labelled with a Biohazard symbol. At the collection location, these sharps containers are packaged in

a secondary containment packaging in the form of a corrugated cardboard box with the universal Biohazard symbol on the outside and lined with a 2 mm plastic bag. When ready for shipment,

collection locations tie off the box liner, seal the box and arrange for shipment. The service providers

contracted by HPSA (Stericycle, ULC or ECS Cares) transport the boxes of biomedical sharps to an HPSA

approved disposal site where the boxes of biomedical sharps/sharps containers are autoclaved. The approved disposal facility is managed by Daniels Healthcare. Used cytotoxic sharps collected through the OSCP are received from consumers in sharps containers

labelled with a cytotoxic symbol. At the collection location, these sharps containers are packaged in

lined, corrugated cardboard boxes with cytotoxic l abelling on the outside. When ready for shipment,

collection locations tie off the box liner, seal the box and arrange for shipment. The service providers

contracted by HPSA (Stericycle, ULC. or ECS Cares) transport the boxes of cytotoxic sharps to an HPSA

approved disposal site where the boxes of cytotoxic sharps and sharps containers are incinerated. The

approved disposal facility is managed by Daniels Healthcare. 9

IV. 2021 Collections

A. Pharmaceuticals

Section 9 (2) 3 - The total weight of all of the following that was collected at the collection locations during

the previous calendar year: i. Pharmaceuticals. ii. Containers described in paragraph 3 of section 2, excluding any containers that were recycled. In 2021, a total of 21,871 MRP containers were supplied to the HPSA collection network, and

318,677.3 kilograms of Pharmaceuticals were collected.

In 2021, 304,716.4 kilograms of Pharmaceuticals were safely disposed by Stericycle, ULC in Ontario (note: the delta between tonnage collected and tonnage disposed can be explained by the variation

between the weight captured on the Bills of Lading and the weight on the Certificates of Destruction).

Table 1 provides a summary by region of the total weight of Pharmaceuticals collected through the

4,346 collection locations in 2021.

Table 1

Program Performance - Report on Collection of Pharmaceuticals by

Quarter

Regions# of Sites1

st 2 nd 3 rd 4 th

Year Total (kg)

Greater Toronto1,32218,522.4314,187.6216,170.5518,187.0767,067.67

Huron, Perth, Waterloo, Wellington, Bruce, Grey, Simcoe4979,940.009,397.4511,354.5011,014.2041,706.15

Northern Region2747,256.846,706.107,601.647,741.5229,306.10 Oakville, Burlington, Hamilton, Niagara60112,981.659,192.9010,100.7311,433.5443,708.82 Ottawa and Area2874,881.895,815.486,636.706,301.9523,636.02 Southeastern Ontario1804,755.663,458.104,177.764,543.7016,935.22 Southwestern Ontario44410,332.677,807.1511,535.159,796.8939,471.86

York, Durham, Headwaters, Kawartha, and Northumberland65913,646.8910,243.2312,382.7312,346.2748,619.12

Grand Total434684,651.7368,183.3882,416.3183,425.90318,677.32 10

B. Medical Sharps

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