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Controlled substances guidance for community pharmacists: security, inventory reconciliation and record-keeping

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

Any questions of interpretation concerning this guidance document should be directed to the National Compliance Section within the Office of Controlled Substances at compliance-conformite@hc-sc.gc.ca.

Preface

The following regulations, made under the Controlled Drugs and Substances Act (the Act), outline various regulatory requirements for pharmacists handling controlled substances:

This document provides guidance and recommendations to pharmacists on how they can meet regulatory requirements for controlled substances, in the areas of:

  1. security
  2. inventory reconciliation
  3. record-keeping

The words "must" and "should" are used throughout the document. The word "must" represents a regulatory requirement, while the word "should" represents a recommendation on how to meet a regulatory requirement. Note: there may be more than one way to meet a regulatory requirement.

Provincial or territorial regulatory requirements may be stricter than what is outlined in this document. It is the responsibility of community pharmacy professionals to consult with the relevant provincial or territorial pharmacy regulatory authority for further guidance.

Security

Pharmacists must take all reasonable steps necessary to protect all controlled substances against loss or theft, including post-consumer returns and unserviceable stock.

Health Canada does not require that these products be stored in any specific way. This is due to differing provincial or territorial requirements in how controlled substances are shelved and stored at the pharmacy level. For example, we recommend:

It is the pharmacist's responsibility to ensure that the method they use to manage their controlled substances stock:

The following are examples of practices that may be used to achieve compliance with federal regulations. The list of recommendations is not exhaustive. Other methods may be deemed acceptable if the regulatory requirement of protecting controlled substances against loss or theft is met.

Alarm system

If the pharmacy is part of a retail space, the dispensary should be on a separate alarm zone.

Physical security measures

To protect controlled substances against loss or theft, use:

Restricted access to dispensary

A pharmacist must supervise all activities involving access to controlled substances, including cleaning or maintenance.

Do not share or post ordering codes for controlled substances, PINs, or keys.

Reasonable inventory

Order quantities of controlled substances that align with prescription volumes. This will prevent excessive losses in the event of:

Destruction procedures and records

Pharmacists must comply with security and record keeping requirements for post-consumer returns and unserviceable stock that are:

More information:

Inventory and reconciliation

Inventory reconciliation activities must be performed by either:

The following recommendations around inventory reconciliation will assist pharmacists with the detection and prevention of loss or theft. The list of recommendations is not exhaustive.

  1. Perform regular inventory reconciliations, including complete manual inventory counts of controlled substances.
  2. At minimum, perform a complete inventory reconciliation:
    • before and after a pharmacy move
    • after the pharmacy receives a non-compliant inspection rating from Health Canada
    • after a change in the pharmacy manager or owner or any unexpected staffing changes
    • after an event where controlled substances security was compromised, such as:
      • armed robbery or break and entry
      • suspected or detected internal theft or drug diversion
      • discovery of faulty security measures (for example, an unlocked window)
  3. Maintain a perpetual active inventory to flag any discrepancies in real-time.
  4. At minimum:
    • separate the records for active inventory from the records for unserviceable stock (including expired controlled substances)
    • record any brand or generic substitutions to ensure accuracy
  5. Generate the necessary inventory and sales reports using logistical software to allow an audit to be conducted at any time.

Conducting an effective inventory reconciliation

The recommended steps to conduct an effective inventory reconciliation are as follows:

  1. Retrieve the perpetual active inventory.
  2. Calculate the starting baseline inventory of each controlled substance:
    • start with the previous reconciled inventory count
    • add all the controlled substances received since the last reconciled inventory count according to the receiving records
      • include any substances transferred from another pharmacy for emergency purposes
    • subtract the number of controlled substances sold or provided since the last reconciled inventory count
      • include any substances destroyed or returned to a licensed dealer
    • verify that all corresponding prescriptions for controlled substances sold or provided are present
    • adjust for any justified, manual inventory changes since the last reconciled inventory count
      • justify manual adjustments of the perpetual inventory using supporting documentation
      • regularly review all manual adjustments and restrict the ability to make manual adjustments in the inventory system
  3. Complete a manual count of the current inventory in stock.
  4. Investigate and record reasons for any discrepancies (shortages or overages) between:
    • the starting baseline inventory
    • the manual count of the current inventory
  5. Investigate and record reasons for any discrepancies (shortages or overages) between:
    • the perpetual active inventory and
    • the manual count of the current inventory
  6. Report any unexplained shortages to the Office of Controlled Substances as a loss or theft within 10 days of discovery, as required by the Regulations.
  7. Develop and implement measures to maintain an accurate inventory.

Methadone prescriptions

The Government of Canada introduced regulatory amendments to change the way methadone is regulated under the Act and the Narcotic Control Regulations.

Effective May 19, 2018, practitioners may prescribe, administer, sell or provide methadone without an exemption under subsection 56(1) of the Act. Pharmacists no longer need to contact Health Canada to verify if a practitioner holds a valid subsection 56(1) exemption to prescribe methadone.

Spillages of methadone do not require a loss or theft report if the spillage:

The person who saw the spill happen should sign the perpetual inventory log. The spillage records must be kept on-site at the pharmacy for 2 years.

More information:

Records

This section outlines the types of records that must be kept in the pharmacist's possession for a period of at least 2 years (or longer when required by provincial or territorial regulations) in a manner that permits an audit to be made.

More pharmacies are moving to a paperless environment and filing records electronically. Health Canada has no objection to this transition, if:

Any record, whether paper or electronic, must be retrievable in a timely manner to permit an efficient audit to be made.

More information:

Purchase and receiving records

A pharmacist must document when they receive a controlled substance, including exempted codeine products, from a:

The following information must be entered in a book, register or other record:

  1. the date the substance was received
  2. the name and quantity of the substance received
  3. the name and address of the person from whom the substance was received
  4. for benzodiazepines and targeted substances:
    1. the strength per unit
    2. the number of units per package
    3. the number of packages

The pharmacist should enter the name of the pharmacy staff receiving the controlled substance.

Dispensing records (sales)

The dispensing records should be in chronological order to allow an audit to be made. The records must contain the:

  1. name, quantity, and form of the substance
  2. number assigned to the order or prescription
  3. date on which the substance was sold or provided
  4. name and address of the person named in the order or prescription
  5. name or initials of the pharmacist who sold or provided the controlled substance
  6. name, initials and address of the practitioner who issued the order or prescription

Special prescription file

A pharmacist must maintain a special prescription file for narcotics and controlled drugs. The file must include:

The electronic or scanned records must:

Extending, renewing, or transferring a prescription

On Oct 2, 2020, an exemption was granted to allow  pharmacists to prescribe, sell, provide or transfer a controlled substance to a patient under their professional treatment in order to extend or renew an existing prescription.

More information

Emergency transactions

A pharmacist may sell or provide controlled substances to another pharmacist for emergency purposes. The order must be captured by both pharmacists in their respective receiving and dispensing records.

Emergency purposes can include:

The sections of the Regulations that allow for emergency sale or provision of controlled substances are not intended to be used for stock management purposes. Typically, the quantities involved would be limited to what is necessary to fill a single prescription.

Pharmacy closure or transfer of ownership

In the event of a pharmacy closure, the pharmacist may return controlled substances to:

In the event where the controlled substances are transferred to another pharmacist, at the time of the transfer, both pharmacists should:

All pharmacists must:

To notify the Minister of the transfer of controlled substances, email us the completed form provided to you by:

Email: compliance-conformite@hc-sc.gc.ca.

Return authorization records

A pharmacist may return a controlled substance to the licensed dealer who sold or provided the product, upon receipt of a written order (also known as the return authorization), signed and dated by the licensed dealer. The pharmacist must:

Loss or theft reports

All reportable losses and thefts, regardless of the amount lost, must be reported to Health Canada's Office of Controlled Substances within 10 days of the discovery.

A loss is reportable when:

Reporting the loss or theft

Report the loss or theft:

OR 

Email: ocs.monitoring-surveillance.bsc@hc-sc.gc.ca.

The report should include:

Patient information must not be included in the loss or theft report.

The pharmacist must keep a copy of the loss or theft report on site for 2 years and make it available upon request (such as during a Health Canada inspection).

Types of losses

Inventory may be lost:

Indicate the type of loss on the loss or theft report.

Loss or theft in transit

Should a pharmacist discover an unexplainable loss or theft that occurred in transit, they are responsible for investigating and reporting the loss or theft. Losses or thefts in transit include losses occurring during a delivery from:

Loss unexplained

Manual inventory counts that fall short of the active perpetual inventory require investigation and reconciliation. Any identified shortage of inventory that cannot be reconciled or definitively explained must be reported.

Forgeries

Pharmacists must submit a loss or theft report form when a forged prescription is dispensed. Attempted forgeries where no controlled substances were dispensed do not need to be reported to Health Canada.

More information:

Notice of restriction

The Office of Controlled Substances issues the notice of restriction (NOR), pursuant to the Act and its associated regulations, to restrict dispensing privileges for pharmacists or prescribing privileges for practitioners for controlled substances. A NOR does not prevent a restricted individual from accessing controlled substances as a patient.

A pharmacist or practitioner may be named in a NOR for any of the following reasons:

Once a NOR is issued, Health Canada must notify the relevant pharmacists and licensed dealers. Upon review of an order or prescription, pharmacists and licensed dealers must verify whether a practitioner or pharmacist is restricted, including when pharmacists provide controlled substances to other pharmacists for emergency purposes.

A partial list of pharmacists and practitioners named in a NOR is available online. Restrictions that are not published online are provided directly to pharmacists and to licensed dealers. Pharmacists should keep an accessible copy of the NOR list at the pharmacy for awareness of any restrictions when dispensing controlled substances.

More information:

List of restricted health care practitioners and pharmacists named in a notice of restriction

Submitting a notice of restriction request to the Office of Controlled Substances

To have a NOR issued, the provincial or territorial professional regulatory authorities must email the National Compliance Section at the Office of Controlled Substances with:

OR

Email: compliance-conformite@hc-sc.gc.ca

Additionally, the provincial or territorial professional regulatory authority should notify the National Compliance Section of any modifications to the listed restrictions, such as if the restrictions have changed, or if the pharmacist or practitioner is:

To have a NOR removed, the provincial or territorial professional regulatory authorities must email the National Compliance Section at the Office of Controlled Substances with:

AND

Some provincial or territorial professional regulatory authorities may be able to restrict the prescribing or dispensing privileges of a pharmacist or practitioner without the issuance of a NOR by Health Canada. NORs issued by Health Canada have a minimum of one-year validity period during which the restrictions would have to remain in place for the practitioner or pharmacist named in the NOR.

Email us to request more information on the NOR, or to request the NOR list.

Email: compliance-conformite@hc-sc.gc.ca.

Section 56 class exemption

This exemption is for patients, practitioners and pharmacists prescribing and providing controlled substances in Canada. It allows pharmacists to:

The exemption allows practitioners to issue verbal prescriptions for controlled substances. Pharmacists can accept these verbal prescriptions. Any controlled substance prescribed, sold, provided, or transferred under the exemption must be to continue the treatment that patients are already receiving.

The prescription transfer records must contain:

The exemption details specific terms and conditions, including record keeping requirements.

The implementation of the exemption is up to each province or territory. Pharmacists must check with their provincial or territorial pharmacy regulatory authority whether their province or territory has implemented the exemption.

More information:

Definitions

Controlled drug: any drug set out in the Schedule to Part G of the FDR or anything that contains any substance set out, including a preparation

Controlled substance: refers to a narcotic, controlled drug or targeted substance, as laid out in Schedules I, II, III, IV or V of the CDSA

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

Emergency transfer: To be done on a prescription basis per provisions of NCR 45(1), FDR G.03.014(b), or order basis per provisions of BOTSR 55(1)(b)(ii) and 55(2)

Licensed dealer: the holder of a controlled drugs and substances dealer's licence issued under the NCR, the FDR – Part G or the BOTSR

Local destruction: on-site destruction

Narcotic: any substance set out in the Schedule to the NCR or anything that contains any substance set out in that Schedule

Post-consumer return: means unused or expired substance that is, or contains, a narcotic, targeted substance or a controlled drug, 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

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 unused, expired and/or that cannot be dispensed for some reason

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