Guidance Document for Pharmacists, Practitioners and Persons in Charge of Hospitals: Handling and Destruction of Unserviceable Stock Containing Narcotics, Controlled Drugs or Targeted Substances

Controlled Substances Directorate
Opioid Response Team

Effective Date: May 18, 2018

Foreword

Guidance documents are meant to provide assistance to regulated parties on how to comply with governing statutes and regulations. Guidance documents also provide assistance to departmental staff involved in administering legislation, regulations and/or policies in a manner that is fair and consistent.

Guidance documents are administrative instruments that do not have the force of law and are thus not intended to substitute for, supersede or limit the requirements set out under prevailing legislation. In the case of any discrepancy between this document and the actual text of prevailing legislation, the legislative text will prevail.

It is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in this document in order to allow the Department to verify compliance with relevant regulations and/or adequately mitigate the risk of diversion of controlled substances to the illegal market.

Any questions of interpretation concerning this guidance document should be directed to the Compliance and Monitoring Division within the Controlled Substances Directorate (CSD) at hc.compliance-conformite.sc@canada.ca.

1.0 Introduction

The Controlled Drugs and Substances Act (CDSA) provides for the control of substances that can alter mental processes and that may produce harm to health and to society when diverted or misused. Except as authorized under its related regulations or via an exemption issued under section 56 of the Act, most activities involving substances regulated under the Act, e.g., possession, import, export, trafficking, possession for the purposes of trafficking, production, etc., are prohibited.

The substances regulated under the CDSA are grouped into Schedules I to VI to the Act. Schedules I to V list controlled substances while Schedule VI lists precursor chemicals, which can be used to make controlled substances.

At the present time, there are several sets of regulations made under the CDSA that set out the circumstances under which activities with controlled substances or precursor chemicals are permitted. Four regulations are relevant to this Guidance Document:

• Benzodiazepines and Other Targeted Substances Regulations (BOTSR)
• Narcotic Control Regulations (NCR)
• Part G of the Food and Drug Regulations (FDR-Part G )
• New Classes of Practitioners Regulations (NCPR)

Unserviceable stock is a drug product containing a narcotic, controlled drug or targeted substance that is unusable, expired and/or that cannot be dispensed.

1.1 Context

This guidance document replaces Circular Letter No. 654 (Local Destruction of Narcotics and Controlled Drugs at Hospitals), Circular Letter No. 655A (Local Destruction of Narcotics and Controlled Drugs at Community Pharmacies) and Circular Letter Re: Local Destruction of Narcotics and Controlled Drugs by Practitioners dated November 1, 1984 and is being issued in conjunction with the Guidance Document for Pharmacists and Licensed Dealers Who Destroy Narcotics, Controlled Drugs or Targeted Substances: Handling and Destruction of Post-Consumer Returns Containing Narcotics, Controlled Drugs or Targeted Substances.

1.2 Objectives

This guidance will set out procedures for practitioners, pharmacists and persons in charge of a hospital involved in the handling and destruction of unserviceable stock.

1.3 Scope and application

This document applies to:

• pharmacists, as referenced in the NCR, FDR-Parts G, and BOTSR;
• persons in charge of a hospital, as referenced in the NCR, FDR-Part G, BOTSR;
• practitioners, as referenced in the NCR, FDR-Part G, BOTSR, NCPR; and
• licensed dealers including those licensed to possess narcotics, controlled drugs or targeted substances for the purposes of destruction, as referenced in the NCR, FDR-Part G, and BOTSR.

2.0 Roles and Responsibilities

2.1  Pharmacists working in a retail or community pharmacy

Pharmacists are responsible for the secure storage, proper handling and destruction of unserviceable stock, including record keeping. There is no longer a requirement for pharmacists to send Health Canada a record of the destructions performed.

2.2  Hospital pharmacists and persons in charge of a hospital

Hospital pharmacists or persons in charge of a hospital are responsible for the secure storage, proper handling and destruction of unserviceable stock, including record keeping. Only a pharmacist working in a hospital pharmacy or a person in charge of a hospital can carry out local destruction activities in a hospital, and this responsibility cannot be delegated or discharged to another employee except where the unserviceable stock represents any partial or unusable doses, and the unserviceable drug is already outside the pharmacy, e.g., on a ward. In this case, local destruction can be carried out by a licensed health professional, at the discretion of the person in charge of a hospital.

2.3  Practitioners working outside of a hospital

Practitioners are responsible for the secure storage, proper handling and destruction of unserviceable stock, including record keeping. Practitioners must carry out local destruction activities in their location of practice, as required, and this responsibility cannot be delegated or discharged to another employee.

2.4  Licensed Dealers

Licensed dealers must ensure the secure storage of unserviceable stock, meet record-keeping requirements and carry out any destruction of unserviceable stock in accordance with all applicable federal, provincial and municipal legislation.

3.0 Destruction

• destroy the substances locally (see section 3.1);
• send the substances to a licensed dealer (see section 3.2); or
• return the product to the licensed dealer who sold or provided them the narcotics, controlled drugs, or targeted substances (see section 3.3).

3.1 Local Destruction

Local destruction means on-site destruction at a retail pharmacy, hospital pharmacy or location of practice.

3.1.1 Method

The goal of local destruction is to alter or denature the narcotics, controlled drugs, or targeted substances to such an extent that consumption is rendered impossible or improbable. It is the responsibility of the person destroying the substances to ensure that this requirement is met. The person destroying the substances must follow all applicable municipal, provincial and federal environmental laws.  Practitioners, pharmacists and persons in charge of a hospital should be aware that the destruction process may vary from substance to substance depending on the chemical or physical properties of the substance in question, however a change of state is recommended (i.e. from solid to liquid).

The use of chlorine bleach to destroy narcotics, controlled drugs, or targeted substances has been reported to result in exothermic reactions, and should only be used as a method of destruction by licensed dealers who have the appropriate equipment for this procedure.

Pharmacists, practitioners, and persons in charge of hospitals are encouraged to consult Workplace Hazardous Materials Information System (WHMIS) sheets or their respective provincial regulatory colleges for instructions on the appropriate method of destruction of controlled substances.

Once subjected to local destruction, narcotics, controlled drugs, or targeted substances may be placed in a pharmacy waste container or other appropriate container and disposed of in a manner that is safe, environmentally responsible, secure and compliant with legal and professional requirements to protect confidential patient information.  Already denatured products need not be sent to licensed dealers for disposal.

3.1.2 Witnessing

All local destructions must be witnessed by a practitioner, pharmacist, a pharmacy intern, or a pharmacy technician. A Health Canada inspector may also serve as a witness should they be present.

3.1.3    Record Keeping

Health Canada no longer requires pharmacists, practitioners or persons in charge of hospitals to send destruction authorization requests to Health Canada in order to proceed with local destruction.

For the purpose of stock reconciliation, a practitioner, pharmacist or person in charge of a hospital proceeding with a local destruction must keep a record of the unserviceable stock they are subjecting to local destruction. The record must set out the following information:

• the brand name or common name of each narcotic, controlled drug, or targeted substance that is being destroyed;
• the quantity and strength per unit of the narcotic, controlled drug, or targeted substance that is being destroyed;
• the method of destruction used; and
• the date that the destruction took place.

The record must be signed and dated by the pharmacist, practitioner or person in charge of the hospital who carried out the destruction and by the witness. Both persons must sign and print their names on a joint statement indicating that they witnessed the destruction and that the substance was altered or denatured to such an extent that its consumption was rendered impossible or improbable.

This information must be recorded in a register similar to that required for orders involving narcotics, controlled drugs, and targeted substances, and must be retained for a period of two years, in a manner that permits an audit to be made.

3.2 Sending to a Licensed Dealer

Only a practitioner, pharmacist or person in charge of a hospital can authorize a non-denatured narcotic, controlled drug, or targeted substance to be sold or provided to a licensed dealer, and this responsibility cannot be delegated or discharged to another employee.

3.2.1 Record Keeping

Every transaction relating to unserviceable stock between a pharmacist, practitioner, or person in charge of a hospital and a licensed dealer must be supported by a written order signed by the licensed dealer specifying:

• the name, quantity and strength per unit of each substance in the stock being sold or provided for destruction;
• the name and address of the licensed dealer to whom it was sold or provided; and
• the date on which it was sold or provided.

The order must indicate that the sole purpose of the transaction is the destruction of the unserviceable stock.

Every order prepared in relation to the sale or provision of unserviceable stock to a licensed dealer must be recorded in a register similar to that required for other orders involving narcotics, controlled drugs, and targeted substances.

These records must be retained for a period of no less than two years, in a manner that permits an audit to be made.

3.3 Returning to the Licensed Dealer that Sold the Product

For substances that are being returned to the licensed dealer that sold them, the order and record keeping requirements in section 3.2.1 apply.

Annex A: Definitions

The following definitions are provided for reference:

controlled drug

a drug set out in the Schedule to Part G of the FDR, including a preparation^{Footnote 1}

to destroy

to alter or denature a controlled substance to such an extent that its consumption is rendered impossible or improbable;

licensed dealer

the holder of a dealer's licence issued under the NCR, the FDR – Part G or the BOTSR;

local destruction

on-site destruction;

location of practice

a location devoted to the diagnosis and care of outpatients by a practitioner as defined by their professional scope of practice;

narcotic

any substance set out in the Schedule to the NCR or anything that contains any substance set out in that Schedule^{Footnote 2}

pharmacy technician

a person who works in a pharmacy or dispensary and meets any applicable provincial or professional requirements in order to work as a pharmacy technician or equivalent designation.

practitioner

a person who is registered and entitled under the laws of a province to practise in that province the profession of medicine, dentistry or veterinary medicine, and includes any other person or class of persons prescribed as a practitioner, including in the New Classes of Practitioners Regulations^{Footnote 3}

targeted substance

a controlled substance that is included in Schedule 1 to the BOTSR or a product or compound that contains a controlled substance that is included in Schedule 1 to the BOTSR;

unserviceable stock

drug product containing a narcotic, controlled drug or targeted substance that is unusable, expired and/or that cannot be dispensed.