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

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Definitions

Controlled substance
Any substance listed in Schedules I-V of the CDSA. This includes any preparations containing these substances, except for test kits.
Date of discovery
The date on which the official individual first became 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 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.
Post-consumer return
Means unused or expired substance that is, or contains, a narcotic, targeted substance or a controlled drug, and 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 with the CDSA), and hospitals.
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, precursors or both.
Theft
The removal of any quantity of controlled substances or precursors under the custody of a regulated party without legitimate consent.
Unserviceable stock
Stock that is unusable due to damage, breakage, spills, contamination or expiration.

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 and precursors under their control or in their possession.

Protective measures can include many proactive steps. The review of practices and procedures involving controlled substance 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.

Information

When controlled substances and precursors are over-dispensed or wrongly dispensed, you should take all reasonable steps to recover the items before submitting a loss or theft report.

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:

You must keep all records on-site for two years if they contain information which must be retained under the relevant regulations. This applies even if an incident is not reportable to Health Canada. The two-year period starts the day after the last record in the document.

Tip

We recommend periodic inventory reconciliation and thorough reviews of documentation and other records to help identify losses or thefts. This should also include unserviceable stock and post-consumer returns.

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 this document, a loss is reportable when:

All reportable losses involving controlled substances or precursors must be reported regardless of the amount.

Losses or thefts can also involve unserviceable stock or post-consumer returns.

Which incidents should not be reported

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

Documented dispensing of a prescription to the wrong patient or for an incorrect quantity should not be reported, if the pharmacist can retrieve it.

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 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 can be explained by normally accepted business activities, and is therefore not reportable to the OCS, the following information must still be kept on site:

Who should report

The official individual that discovers or is informed of the loss or theft is responsible for reporting.

The official individual varies with the type of site. For example, for a controlled substances licensed dealer, the Qualified Person in Charge (QPIC) or their alternate would represent the official individual. For a pharmacy, a staff pharmacist or the pharmacy manager (if a pharmacist) would be the official individual.

Important

If someone other than the official individual discovers a loss or a theft, they should inform the official individual as soon as possible.

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 must be retained onsite for two years. This two-year period begins the day after the last record is recorded in the document.

Information

Inspections conducted by a regulatory authority are not internal investigations.

How to report a loss or theft

Submit your report using:

How to amend a report

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 initial report and selecting "Amendment" as the type of report on the form.

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."

Type of report being submitted

When reporting an incident 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:

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.

Reporting contact information

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

Site information

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

Information

Licensed dealers and registered dealers should ensure that the site licence number corresponds to the type of substances being reported (controlled substances or precursors).

Incident information

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

Information

Self and third-party audits or investigations are not inspections conducted by regulatory authorities.

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 B for more details on the timeframes for reporting to police.

Licensed dealers and registered dealers must notify the police of all thefts, unexplainable losses based on normal business activities 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. Similarly, any reportable incident involving precursors, regardless of the regulated party, must be reported to the police within 24 hours of discovery.

Important

Do not include the police report or any sensitive or private information in the loss or theft report.

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:

Incident in transit

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

Information

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

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.

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.

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