Guidance on reporting loss or theft of controlled substances and precursors (CS-GD-005): Reporting guidelines and process

On this page

• Definitions
• Prevention of losses and thefts of controlled substances and precursors
• Loss or theft of controlled substances and precursors
  • Which incidents should be reported
  • Which incidents should not be reported
  • Who reports
  • When to report
• Internal investigation
• How to report a loss or theft
  • Type of report being submitted
  • Reporting contact information
  • Site information
  • Incident information
  • Police reports
  • Loss in transit
  • List of controlled substances and precursors lost or stolen

Definitions

Controlled substance

A substance included in Schedule I, II, III, IV or V of the Controlled Drugs and Substances Act.

Date of discovery

The date on which the official individual first becomes aware that a suspected loss or theft 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) or section 56.1 of the Controlled Drugs and Substances Act, such as but not limited to: paramedics, researchers.

Loss

The physical disappearance of controlled substances or precursors that is unexplained at the time of discovery.

Official individual

A regulated healthcare professional or other individual designated in accordance with the Controlled Drugs and Substances Act and its associated regulations who discovers or is informed of a loss or theft of a controlled substance or a precursor under their control or in their possession.

Controlled substances previously returned by an individual for the purposes of destruction

Also known as post-consumer returns, a controlled substance previously returned by an individual to a pharmacist, pharmacy technician, practitioner, or hospital, for the purposes of destruction is an unused or expired substance that is, or contains, a controlled substance.

Precursor

Any substance included in Part 2 of Schedule V or in Schedule VI of the Controlled Drugs and Substances Act.

Regulated party

Includes licensed or registered dealers, pharmacists, practitioners (as defined in the Controlled Drugs and Substances Act, and hospitals.

Provincial professional regulatory authority

Organisation responsible for overseeing and regulating the practice of a healthcare profession.

Site

The premises or facility used to conduct regulated activities or exempted activities with controlled substances or precursors.

Theft

The removal of any quantity of controlled substances or precursors under the custody of a regulated party without legitimate consent.

Prevention of losses and thefts of controlled substances and precursors

Regulated parties must take all reasonable steps to protect and ensure the security of any controlled substances or precursors under their control or in their possession.

Protective measures can include many proactive steps. The review of practices and procedures involving controlled substances and precursors is highly recommended. This is especially important after any loss, theft, or near miss incident when changes to the security measures may be required.

It is the sender's responsibility to maintain the security of the substances in transit.

Losses and thefts of controlled substances and precursors

Losses or thefts of controlled substances or precursors can occur in many ways. It may be difficult to discern if an incident should be reported to the Office of Controlled Substances (OCS). For guidance:

• Appendix A lists examples of common incidents and whether to report them. Note, the list of incidents is not exhaustive.
• Appendix B lists timeframes for reportable incidents.

You must keep all loss or theft report records on-site for two years after the date on which they are provided to our office. Any documentation resulting from an internal investigation should also be retained on-site for two years.

Which incidents should be reported

All thefts involving a controlled substance or a precursor must be reported, regardless of the amount. Forged prescriptions are only considered thefts if a drug product containing a controlled substance or a precursor is dispensed, either partially or fully.

For the purpose of complying with the regulations a loss must be reported, regardless of the amount of substance lost or stolen, when:

• no reasonable explanation on the basis of normally accepted business activities exists for the loss at the time of discovery
• it is suspected that the missing controlled substance or precursor has been potentially diverted to the illegal market

Losses or thefts can also involve controlled substances previously returned by an individual for the purpose of destruction.

Which incidents should not be reported

Do not report any discrepancies in inventory records that can be reconciled with explanations derived from:

• other records
• a physical inventory count
• documented normal business practices

Documented dispensing of a prescription to the wrong patient or for a greater quantity than prescribed should not be reported if the pharmacist can retrieve the controlled substance or precursor.

When a controlled substance or precursor becomes damaged, rendering it impossible to dispense, it does not constitute a loss if the items are still present on-site and accounted for.

Destruction performed in accordance with the applicable federal, provincial and municipal legislation, regulations and official policies is not considered a loss and should not be reported as such.

Licensed dealers are also reminded that in cases where the loss of controlled substances or precursors can be explained by normally accepted business activities, the following information must still be kept on-site:

• the name of the lost controlled substance or precursor and, if applicable, the brand name of the product
• the form and quantity of the controlled substance or precursor and, if applicable:
  • the form of the product containing it
  • the strength per unit of the controlled substance(s)or precursor(s)
  • the number of units per package
  • the number of packages
• the date on which the licensed dealer became aware of the loss and
• the explanation for the loss.

Who reports

The official individual is responsible for reporting. This individual may vary depending on the type of site involved in the loss or theft.

When a loss or theft occurs during the course of transportation, it is the responsibility of the sender to report and investigate the loss or theft. The sender is ultimately responsible for the security of the substances in transit until they reach their final destination. The sender is the regulated party that initiated the shipment (e.g., licensed dealer, pharmacist).

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. See Appendix B for the applicable timelines, starting from the date of discovery. The date of discovery is the moment the official individual becomes aware of the loss or theft.

Internal investigation

An internal investigation should be initiated without delay after an actual or suspected loss or theft is discovered. The investigation must not delay the incident reporting to Health Canada. See Appendix B for the applicable timelines.

If a report is 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 initial report. The official individual should indicate that the amendment is supplemental to the previously submitted loss or theft report (refer to Type of report being submitted for more information). Similar to inventory records associated with controlled substances and precursors, any documentation resulting from an internal investigation should be retained on-site for two years. This two-year period begins on the date on which the last record is recorded in the document.

How to report a loss or theft

Submit your report using:

• Health Canada E-Services Portal, or
• Loss or Theft Report Form (submit via email)

How to amend a report

If the initial report was submitted through the portal, amendments should also be submitted through the portal, but only after the initial submission has been reviewed. Following review, the status of the initial submission will be either "Accepted" or "Not accepted". Once the status appears as "Accepted" or "Not accepted" you will be able to submit your amendment.

If the initial report was submitted by email, amendments should also be submitted by email. Specify this on the form by referencing the date of submission of the initial report and selecting "Amendment" as the type of report on the form.

Type of report being submitted

When using the report form to signal a loss or theft for the first time, select "New Report" and include the date of submission in the report. When updating a previous report, select "Amendment" and include the dates of submission of both the initial report and the amended report.

Amendments should be provided to:

• report updates on previously reported information
• add new information pertaining to a previously submitted report

Multiple amendments can be provided for the same report.

Reporting contact information

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

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

Site information

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

• legal entity name and site name where the official individual currently works
  • a legal entity name is defined as the company at the corporate ownership level and may end in INC., LTD., or is a numbered company
  • a site name is where regulated activities take place and in some cases, a specific store number may be assigned
  • for hospitals and long-term care facilities, legal entity name refers to a Health Authority under which the location is managed and the site name is the facility name
• municipal address and phone number of the site
• type of site that is reporting (for example, pharmacy, hospital, licensed dealer, etc.)
• 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, leave this field blank.
  • licensed dealers and registered dealers
    • Enter the licence or registration number assigned by the OCS.
  • exemptees under section 56 of the Controlled Drugs and Substances Act.
    • Enter the authorization number assigned by the OCS.
    • Exemptees covered by a Class Exemption should enter their professional licence numbers.

Incident information

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

• date of discovery
• incident type (loss or theft) and sub-type (see Appendix A for more details on incident sub-types)
• details regarding the discovery of the loss or theft
• whether the incident was discovered due to an inspection by a provincial professional regulatory authority or due to a Health Canada inspection.

Police reports

Licensed dealers and registered dealers must notify the police of all thefts of controlled substances or precursors within 24 hours of discovery. A confirmation that the police have been notified must accompany the report submitted to the OCS within 72 hours of the date of discovery. See Appendix B for more details on the timeframes for reporting to police.

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 corporation or their provincial professional 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 (not the police officer)
• the incident number assigned to the case by the police service, if applicable

Loss in transit

The official individual that discovers or is informed of a loss in transit must investigate and report the loss. The report must include:

• the name of the company transporting the controlled substances or precursors
• the shipment number or tracking number, if applicable

Who reports

Only the official individual who arranged the shipment (usually the supplier) should report confirmed losses in transit.

List of controlled substances and precursors lost or stolen

The following information regarding the lost or stolen controlled substances or precursors 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 product name and strength should be listed as it appears on the bottle or in inventory records. 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
  • 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)
  • 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.
• The quantity should be precise and based on the dosage form of the substance lost or stolen. This includes fractions, such as half a tablet.