Guidance Document: Reporting Loss or Theft of Controlled Substances and Precursors (CS-GD-005)

Effective date: 2019/12/09
Revised date: 2019/12/09

Foreword

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing laws and regulations. Guidance documents also provide assistance to staff within Health Canada to ensure laws and regulations are administered in a manner that is fair, consistent, and effective.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant programme area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

It is 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 adequately assess the safety and security of controlled substances and precursors. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

For those who deal with post-consumer returns, please refer to the guidance document "Handling and destruction of post-consumer returns containing controlled substances (CS-GD-021)" to know the roles and responsibilities of stakeholders on post-consumer returns.

The following table shows the three types of icons used in this document, and the way they are intended to be used.

Important: Key or cautionary information to know.

Information: Supplementary information like quotes and legal references.

Tip: Suggestions for people to do in order to comply with the regulations.

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.ocs.reporting-rapporter.bsc.sc@canada.ca.

Should any Licences, Registration Certificates, Authorization Certificates, Export or Import Permits, Transhipment Permits, or Transit Permits be lost or stolen, please contact the OCS at 613-952-2177 or hc.ocs-bsc.sc@canada.ca.

Table of Contents

1. Introduction

1.1 Purpose

This document provides guidance to regulated parties and exemptees under the Controlled Drugs and Substances Act (CDSA) and its associated regulations in completing and submitting a Loss or Theft Report Form for controlled substances and precursors.

Regulated parties as well as exemptees under section 56 of the CDSA must notify the Minister of the loss or theft of controlled substances or precursors in accordance with the Narcotic Control Regulations (NCR), Parts G and J of the Food and Drugs Regulations (FDR-G or FDR-J), the Benzodiazepines and Other Targeted Substances Regulations (BOTSR), the Precursor Control Regulations (PCR), or the conditions of their exemption. Reports of any loss or theft of controlled substances or precursors must be submitted to Health Canada's Office of Controlled Substances (OCS) using the Loss or Theft Report Form for Controlled Substances and Precursors (CS-FRM-011).

1.2 Scope

This document was developed to provide guidance to regulated parties in meeting the regulatory requirements for reporting losses or thefts of controlled substances and precursors, including preparations containing these substances.

Under the CDSA, regulated parties include (but are not limited to) licensed or registered dealers, pharmacists, practitioners as defined in the CDSA and New Classes of Practitioners Regulations, and hospitals. This document also applies to exemptees under section 56 of the CDSA who must report any losses or thefts as per the conditions of their exemptions.

1.3 Background

Canada is a signatory to the Single Convention on Narcotic Drugs (1961), the Convention on Psychotropic Substances (1971), and the Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (1988) and is also party to the resolutions set by the International Narcotics Control Board (INCB). Part of the INCB's mandate is to prevent controlled substances and precursors from being diverted to the illegal market.

The OCS works in collaboration with Canadian and international stakeholders in the public and private sectors to ensure that controlled substances and precursors are used for legal purposes. The OCS supports this effort through its administration of laws pertaining to the possession, import, export, production, packaging and sale or provision of controlled substances and precursors listed in the Schedules of the CDSA.

2. Guidance for implementation

2.1 Definitions

Controlled Substance
Any substance listed in Schedules I-V of the Controlled Drugs and Substances Act (CDSA). This including any preparations containing these substances, except for test kits.
Date of Discovery
The date at which the official individual first becomes aware that a suspected loss or theft has occurred.
Destroy
To alter or denature a controlled substance or precursor to such an extent that its consumption is rendered impossible or improbable.
Exemptee
An individual or class of individuals that are exempted under subsection 56(1) and section 56.1 of the CDSA, such as but not limited to: paramedics, researchers, principal investigator of a human clinical trial, research laboratories and officers of the Canada Border Services Agency (CBSA).
Loss
The physical disappearance of controlled substances or precursors that is not the result of a theft, and/or is unexplained at the time of discovery.
Official Individual
A regulated healthcare professional or other individual designated in accordance with the CDSA and its associated regulations. The official individual varies with the type of site. For example, for a licensed dealer of controlled substances, the Qualified Person in Charge (QPIC) or their alternate(s) would represent the official individual. For a pharmacy, the staff pharmacist(s) or the pharmacy manager (if a pharmacist) would be the official individual.
Post-Consumer Return
Means unused or expired substance that is, or contains, a narcotic, targeted substance, a controlled drug, or a precursor, that has been returned by an individual to a pharmacy for the purpose of destruction, but does not include any substance that has been returned to a hospital pharmacy from a patient ward;
Precursor
Any substance listed in Schedule VI of the CDSA.
Regulated Party
Includes (but is not limited to) licensed or registered dealers, pharmacists, practitioners (as defined in the regulations associated to the CDSA), and hospitals.
Site
The premises or facility used to conduct regulated activities or exempted activities with controlled substances and/or precursors.
Theft
The removal of any quantity of controlled substances or precursors under the custody of a regulated party without its legitimate consent.
Unserviceable Stock
Stock that is unusable due to damage, breakage, spills, contamination or expiration.

2.2 Loss or Theft of Controlled Substances and Precursors

Losses or thefts of controlled substances or precursors can occur in many ways, and it may be difficult to discern if an incident should be reported to the OCS.

A summary table of common incidents and whether to report them is provided in Appendix B of this document. Reporting timeframes are provided in Appendix A.

Regardless as to whether an incident is reportable to the Minister, all records associated with controlled substances and precursors must be kept on-site for a period of two years following the day on which the last record is recorded in the document.

Tip: By conducting routine reconciliation of records, transactions and physical inventories, regulated parties may identify possible losses or thefts in a consistent manner and thereby potentially reduce their frequency. This should also include unserviceable stock.

2.2.1 Which Incidents Should be Reported?

All thefts involving a controlled substance or a precursor must be reported, regardless of the amount.

For the purpose of this document, a loss is considered reportable when it is suspected that the missing controlled substance or precursor has been diverted to the illegal market, or when no reasonable explanation on the basis of normally accepted business activities exists for the loss at the time of discovery. All reportable losses involving controlled substances or precursors must be reported regardless of the amount.

Losses or thefts can also involve unserviceable stock.

Should there be multiple reportable incidents, such as different discovery dates or incident types, multiple reports should be submitted. Only one incident of loss or theft should be reported per report form. Multiple reportable incidents captured on a single report form will not be accepted.

Important: Forged prescriptions are only considered thefts if a drug product containing a controlled substance or a precursor is actually dispensed, either partially or fully. The dispensed amount should be reported as the quantity stolen. Attempted forgeries where no drug products were dispensed are not to be reported.

2.2.2 Which Incidents Should Not be Reported?

Any discrepancies in inventory records that can be reconciled with explanations derived from other records, documented normal business practices, or a physical inventory count are not to be reported. Documented dispensing of a prescription to the wrong patient or for an incorrect quantity should not be reported as the pharmacist can account for the inventory discrepancy.

When a controlled substance or precursor, becomes unserviceable, it does not constitute a loss if the items are still present on site and accounted for.

Destruction performed in accordance to the applicable federal, provincial and municipal legislation, regulations and official policies are not losses and should not be reported as such.

2.2.3 Who Should Report?

The official individual (for example, pharmacist, practitioner, QPIC, etc.) that discovers or is informed of it by a colleague or employee of the loss or theft is responsible for reporting. If someone other than the official individual discovers a loss or a theft, they should inform the official individual as soon as possible.

2.2.4 When to Report?

The timeframe to report a loss or theft differs based on the type of substance (controlled or precursor) lost or stolen and the type of regulated party. The date of discovery is the moment the official individual becomes aware of the loss or theft. If someone other than the official individual discovers a loss or a theft, they should inform the official individual as soon as possible. See Appendix A for the applicable timelines.

2.3 Internal Investigation

An internal investigation should be initiated without delay after a loss or theft, or a suspected loss or theft, is discovered. The investigation must not delay the reporting of the incident to the Minister. See Appendix A for the applicable timelines.

If a report was submitted to the OCS prior to the conclusion of an internal investigation, any additional information from that investigation should be provided to the OCS as an amendment to the original report. The official individual should indicate that the amendment is supplemental to the previously submitted loss or theft report (refer to Section 2.4.1 for more information). Any documentation as a result of an internal investigation must be retained onsite for a period of two years following the day on which the last record is recorded in the document.

2.4 How to Report a Loss or Theft

The loss or theft report form is available online: Loss or Theft Report Form for Controlled Substances and Precursors.

Possible ways to currently submit include:

  • Download form and email.
  • Download form and fax.

Contact Information for the Office of Controlled Substances:

Tel: 613-952-2177
Fax: 613-957-0110

E-mail: hc.ocs.reporting-rapporter.bsc.sc@canada.ca.

Any additional information provided post-submission should be sent as an amendment to the original report and specified as such on the form by referencing the original report's date of submission and checking the relevant type of report on the form itself.

2.4.1 Type of Report Being Submitted

When reporting an incident for the first time, "New Report" needs to be selected.

When updating a previously submitted report, "Amendment" needs to be selected and the date of the original submission to the OCS is to be provided.

Amendments should be provided to report updates on previously reported information, or to provide new information pertaining to a previously submitted report. Multiple amendments can be provided for the same report.

Tip: If the quantities of lost or stolen products are amended, the quantity that is still missing should be indicated on the form. In a situation where a full recovery for a given product is made, the value of "0" should be stated.

If any additional information is included with the report, it should be indicated in the top right corner of the form.

2.4.2 Site Information

The following administrative information must be included in a loss or theft report:

  • The name of the site that is reporting the loss or theft exactly as it appears as per their accreditation/licence/registration.
  • The Canada Revenue Agency Business Number, if available.
  • The address where the site is located along with the phone number of the site at which the official individual is currently working.
  • The type of site that is reporting (for example, pharmacy, hospital, licensed dealer, etc.)
  • The site's licence/accreditation/authorization number as assigned by the relevant licensing body:
    • Pharmacy:
      • Enter the site's licence/accreditation number as assigned by the College of Pharmacists in the respective province or territory. Otherwise, the licence number(s) of the owning pharmacist(s) should be entered.
    • Hospitals:
      • Enter the site's licence/accreditation number as assigned by the respective regulatory body. Otherwise, this field can be left blank.
    • Licensed Dealers and Registered Dealers:
      • Enter the licence number assigned by the OCS for the controlled substances or precursors reported as lost or stolen.

      Information: Licensed Dealers should prepare a separate report for controlled substances and precursors and provide the licence number that lists the substances that are reported as lost or stolen.

    • Licensed Researchers:
      • Enter the file number assigned to them by the OCS.
    • Exemptees under section 56 of the CDSA:
      • Enter the authorization number assigned by the OCS. Exemptees that carry a Class Exemption should enter their professional licence numbers.

2.4.3 Incident Information

The following information regarding the incident must be included in a loss or theft report:

  • The date of discovery;
  • Details regarding the discovery of the loss or theft;
  • The type of incident, meaning a loss or a theft; and
  • The incident sub-type (such as Loss Unexplained, Manufacturer's Shortage, Unusual Waste, Other, Armed Robbery, Break and Entry, Filled Forged Prescription, Grab Theft, Pilferage, Other). See Appendix B for more details.

Information: If there is proper documentation to support a miscount or erroneous dispensing, the incident is not reportable. If no such documentation exists, it should be reported as a Loss Unexplained.

2.4.4 Police Report and Incident in Transit

Additional information about the incident involving the police or during transit should be reported, if applicable.

2.4.4.1 Police Reports

Based on the regulated party, it may be mandatory to report a loss or theft of controlled substances or precursors to the police within 24 hours of the discovery. See Appendix A for more details on the timeframes for reporting to police.

Licensed dealers and registered dealers must notify the police of all thefts, unexplainable losses and unusual waste within 24 hours of discovery. A confirmation that the police have been notified must accompany the loss or theft report submitted to the OCS within 72 hours of the date of discovery.

Important: Do not include the police report or any sensitive or private information.

Similarly, any reportable incident involving precursors, regardless of the regulated party, need to be reported to the police within 24 hours of discovery. A summary of the report to the police should accompany the loss or theft report submitted to the OCS within 72 hours of the date of discovery.

In cases where the regulations do not specify that a report to police must be made, it is recommended that the official individual follow the best practices of their corporate or regulatory authority.

If the loss or theft is reported to police, the following information should be included in the loss or theft report:

  • The date the police service was contacted;
  • The name of the police service; and
  • The incident number assigned to the case by the police service

2.4.4.2 Incident in Transit

The official individual that discovers the reportable incident is responsible for the reporting of the incident in transit and must specify:

  • The name of the company transporting the controlled substances or precursors;
  • The shipment number/tracking number for the transaction; and
  • The name of the regulated party from which the shipment originated or to which it was destined.

Information: If a loss or theft occurs during a shipment directly to a patient, please do not provide patient information on the loss or theft report. Simply enter "To patient" as the recipient's name.

2.4.5 List of Controlled Substances and Precursors Lost or Stolen

The following information regarding the controlled substances or precursors lost or stolen must be included in the report:

  • The Drug Identification Number (DIN) or Natural Product Number (NPN) of the health product, if applicable. The DIN or NPN is a unique identifier for the health product and should always be listed if known.
  • The trade name and strength of the product should be listed as it appears on the bottle or in inventory reports. It is imperative that the product name be filled out as comprehensively as possible (without the use of acronyms or internal short forms). If the trade name is unknown, the proper or chemical name (generic name) of the controlled substance or precursor, along with the name of the manufacturer should be listed. Similarly if the lost or stolen item is a raw material, provide its name as comprehensively as possible (without the use of acronyms or internal short forms).

Information: If a compounded product is lost or stolen, the controlled substance or precursor should be reported as the raw material present in the compounded product.

  • The dosage form of the health product should be listed. Some of the common dosage forms are as follows:
    • Capsule
    • Implant
    • Liquid
    • Patch
    • Post-Consumer Return Container
    • Powder
    • Pump
    • Sachet
    • Suppository
    • Tablet
  • The quantity should be precise and based on the dosage form of the substance lost/stolen, this includes fractions, such as half a tablet. For example, if a single bottle of 100 tablets is lost or stolen, the quantity listed should be 100 tablets, not 1 bottle. If the substance is a powder, please specify the unit lost or stolen in mg or g (as applicable). If the substance is a liquid, please specify the volume lost or stolen in mL or L as well as the concentration of the liquid (as applicable).

Tip: The last recorded inventory count may be used to determine the quantity of a substance or precursor lost or stolen in cases where the exact number is hard to determine, such as for thefts.

2.4.6 Reporting Contact Information

The following contact information must be included in a loss or theft report:

  • The legal name of the official individual reporting;
  • Their professional title (for example, pharmacist, qualified person in charge, veterinarian, etc.);
  • Their professional order licence/accreditation/authorisation number, if applicable;
  • Their professional email address; and
  • The submission date of the report.

Tip: If multiple pages are needed, or if additional information such as an incident report is submitted, please specify this at the top right hand part of the document, "Indicate if supplementary information is attached" (see Section 2.4.1).

Appendices

Appendix A - Timeframes for Reporting

The loss or theft must be made to the OCS within the timeframes specified by the regulations relevant to the missing substances.

When reporting the loss of multiple substances, separate forms should be used to comply with the different timeframes set out in the regulations.

Timeframes for Reporting
Type of Substance Lost / Stolen Regulated Parties Incident Reported to Police within Report of Incident to Be Received by Minister within
Precursors (Precursor Control Regulations) Licensed dealer, registered Dealer subsection 90(2) 24 hours if unexplained or theft 72 hours if unexplained or theft
Pharmacist, practitioner, hospital section 91.96
Narcotics (Narcotics Control Regulations) Licensed dealers section 27.2 24 hours if unexplained or theft 72 hours if unexplained or theft
Pharmacist section 42, practitioner subsection 55(g), hospital subsection 63 (c) Without delay based on best practices 10 calendar days
Targeted Substances (Benzodiazepines and Other Targeted Substances Regulations) Licensed dealers section 35.2, section 43. 24 hours if unexplained or theft 72 hours if unexplained or theft
Pharmacist, practitioner, hospital, hospital subsection 61(2), subsection 72(2) Without delay based

on best practices

10 calendar days
Controlled Drugs (FDR Part G) Licensed dealers section G.02.064, section G.02.074 24 hours if unexplained or theft 72 hours if unexplained or theft
Pharmacist, Practitioner, Hospital section G.03.013, section G.04.002A, section G.05.004 Without delay based on best practices 10 calendar days
Restricted Drugs (FDR Part J) Licensed Dealers subsection J.01.068(1), subsection J.01.068(2), section J.01.077 24 hours if unexplained or theft 72 hours if unexplained or theft
Pharmacist, Practitioner, Hospital subsection J.01.068(1) 24 hours 72 hours

Important: Exemptees under section 56 of the CDSA are required to report as per their exemption conditions.

Appendix B - Type of Incidents

Examples of incidents and whether to report them.
Incident Type Incident Sub-Type Definition Report?
Loss Loss Unexplained A loss that cannot be attributed to any particular cause or action on the basis of normally accepted business activities. Yes
Manufacturer's Shortage The content of a sealed bottle is less than expected after counting. Yes, if greater than value listed in FDR C.01.061.
Manufacturer's Shortage The content of a sealed bottle is less than expected after counting. No, if smaller than or equal to value listed in FDR C.01.061.
Wrong Dispensing Documented dispensing the wrong quantity or to the wrong patient. No
Breakage, and Spillage Change in the dosage form, or other known incident preventing dispensing (for example crushed tablet). No
Unusual Waste Waste or destruction of inventory beyond what is expected on the basis of normally accepted business practices. This could arise from unusual yield loss due to broken equipment, etc. Yes
Miscounts Error made in counting during inventory reconciliation or during dispensing. No, if documented and part of normal business practices.

Otherwise, report as Loss Unexplained.

Overages Quantity found to be in excess of inventory. No
Destruction Denaturation of a controlled substance to an extent that its consumption is rendered impossible or improbable. No
Other Any other type of loss not described above. Yes
Theft Filled Forged Prescription Dispensing of a prescription that was found to be fraudulent. Yes
Unfilled Forged Prescription Forged prescription that was not dispensed. No
Armed Robbery Theft accomplished through threats of violence toward personnel at a site. Yes
Pilferage (Internal Theft) Theft from a site by authorized personnel. Yes
Grab Theft Theft from a site during working hours without warning. The person conducting the theft 'grabs' the product and escapes. Yes
Break and Entry Theft from a site by forced entry. Yes
Impersonation An individual impersonating the individual for which the prescription has been dispensed. Yes
Other Any other type of theft not described above. Yes
Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: