When to Report Losses of Controlled Substances and Precursors
The following information is cited from the Health Canada Guidance Document: Reporting Loss or Theft of Controlled Substances and Precursors. Please click the link to review the Guidance Document in its entirety.
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 Health Canada’s Office of Controlled Substances. For guidance, please see the summary table of common incidents and whether to report them below:
|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|
Regardless of 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.
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). Please see the Guidance Document: Reporting Loss or Theft of Controlled Substances and Precursors for applicable reporting timelines.
Extension of Health Canada Subsection 56 (1) Class Exemption for Patients, Pharmacists Prescribing and Providing Controlled Substances in Newfoundland and Labrador
The current exemption issued by Health Canada for certain provisions of the Controlled Drugs Act (CDSA) and its regulations is set to expire on September 30, 2021. Effective October 1, 2021, a five-year extension of this subsection 56 (1) class exemption from the CDSA, will go into effect. To learn more about this exemption and what NL pharmacists can and cannot do under this exemption, please review the NLPB FAQ on the Health Canada Subsection 56(1) Class Exemption and the Health Canada FAQ on the Subsection 56(1) Class Exemption.
NLPB would like to remind pharmacists that the Health Canada Subsection 56 (1) Class Exemption currently in place does not permit interprovincial transfers of prescriptions for controlled substances.
Proper Documentation of Prescription Transfers
Pharmacists are advised, when any prescription is transferred, the original, written date of the prescription must be reflected in the dispensing record rather than the date that the transfer is completed.
Correct documentation ensures the integrity of the Patient Medication Profile, as per the NLPB Standards of Pharmacy Operation – Community Pharmacy Section 3.5 (a), as well as the patient’s electronic health record, which is used in a variety of settings for clinical decision-making.
The correct documentation process once the transfer has been processed through the Pharmacy Network by the sending pharmacy, is that the receiving pharmacy must create a local prescription from the Pharmacy Network record which then records its subsequent dispenses against that original Pharmacy Network prescription.
Following this process ensures the original written date is maintained and minimizes the likelihood of transcription errors. It also keeps the patient’s Pharmacy Network profile cleaner as no new prescription is created.
If you have questions about how to process a prescription transfer through the Pharmacy Network, please feel free to reach out to the Pharmacy Team at the Newfoundland and Labrador Centre for Health Information.
Approved Changes to the Provincial Drug Schedules
The following additions and revisions to the Provincial Drug Schedules have been approved effective August 24, 2021 to reflect the NDSAC recommendations that were finalized on July 28, 2021:
- the Schedule I entry for herpes zoster vaccine has been revised as follows:
- Herpes zoster (shingles) vaccine (live)
- the following has been added to Schedule II:
- Herpes zoster (shingles) vaccine (non-live recombinant)
- the Schedule III entry for bisacodyl has been revised as follows:
- Bisacodyl and its salts (except when sold in strengths of 5mg or less per oral dosage unit in package sizes containing no more than 105mg of bisacodyl, or 10mg or less per rectal dosage unit/suppository in package sizes containing no more than 50mg of bisacodyl)
- the Unscheduled entry for bisacodyl has been revised as follows:
- Bisacodyl and its salts (when sold in strengths of 5mg or less per oral dosage unit, in package sizes containing no more than 105mg, or 10mg or less per rectal dosage unit/suppository, in package sizes containing no more than 50mg of bisacodyl)
Please see the Provincial Drug Schedules page for more information.
Pharmacist-in-Charge: Leaving your Pharmacy
All licensed pharmacies in Newfoundland and Labrador must have a designated pharmacist-in-charge (PIC) to maintain the license and continue to operate. Therefore, it is a requirement that, as license-holders, all PICs who are leaving their pharmacy – whether through resignation, retirement, or termination – ensure a new PIC is in place prior to leaving.
Before applying for a change in PIC, the current PIC must identify whether the incoming PIC has received authorization from NLPB to be a PIC.
|Is the incoming PIC authorized by NLPB?|
|Complete and submit the Application to Change Pharmacist-in-Charge to NLPB 30 days before the scheduled change.||The incoming PIC must complete and submit the Application for Authorization to be designated Pharmacist-in-Charge to NLPB upon completing all requirements.|
|Complete and submit the Application to Change Pharmacist-in-Charge to NLPB 30 days before the scheduled change.|
Documenting CEUs for Service as a Preceptor
Registrants who served as a preceptor may claim 0.5 credits per week up to a maximum of 6 credits per year as per the Standards of Practice – Professional Development for Pharmacists and Pharmacy Technicians. These credits are classified as non-accredited learning and must be documented in the registrant’s Online Learning Profile.
The Documentation of Credits for Service as a Preceptor form can be retained as supporting documentation in case of an audit. A separate entry and form must be used if acting as a preceptor to more than one student, intern, or technician candidate in a given year.
New Opioid Use and Opioid Use Disorder Resources – CASN, AFPC, and CASWE-ACFTS
The Canadian Association of Schools of Nursing (CASN), the Association of Faculties of Pharmacy of Canada (AFPC), and the Canadian Association for Social Work Education – Association Canadienne pour la formation en travail social (CASWE-ACFTS), are offering a new e-resource and free webinar series on the topic of opioid use and opioid use disorder.
The English e-resource can be found at OUOUD (casn.ca). In the e-resource, you will find the Education Guidelines, eight modules with content related to each learning outcome and indicator in the Guidelines, and Protocols related to naloxone and stigma. The French e-resource will be available later this month.
The webinars will provide a brief overview of the project, a short presentation from a member of the content development team, as well as several guest speakers. The topics below were selected to highlight some of the key themes in the e-resource and provide attendees a unique opportunity to learn from experts in these areas!
Webinar 1: Introduction to opioid use in Canada, the impact of COVID-19, and how stigma and implicit bias affect care.
Wednesday, September 15, 2021, 12:00 PM – 1:30 PM EST
Register now! Free Webinar! Opioid use and opioid use disorder: A look at current trends in Canada, the impact of COVID-19 and stigma, and implicit bias. – Canadian Association of Schools of Nursing / Association canadienne des écoles de sciences infirmières (CASN / ACESI).
Webinar 2: Opioid use and equity-oriented approaches; harm reduction, trauma, and violence informed practice and cultural safety.
Monday, September 20th from 11:30 AM – 1:00 PM EST.
Registration available soon at: www.casn.ca
Webinar 3: Chronic pain and opioid use
Friday, September 24th, 12:00 PM – 1:30 PM EST
Registration available soon at: www.casn.ca
**Please note that these webinars will be held in English and details about a French webinar will be available soon!
- Registrant Contact Information – Registrants are responsible for ensuring that the contact information on their registrant profile, including email address and practice site, is accurate at all times. The NLPB primarily uses email communication to send newsletters, renewal reminders, practice site assessment information, professional development audit information, calls for interest for committees, and other alerts. If the email address on file is incorrect, important information may be missed and/or disclosed to the wrong person. If your contact information changes, please log into the NLPB Online Registrant Portal to update your file with your new contact information as soon as you can.
- Forgot Your Password? – You can retrieve your NLPB Online Registrant Portal password at any time. Under the Login box, click the message that says, “Forgot your password? Click here to restore it.” On the next screen, enter your NLPB username, if you know it, or your email address. Click “Retrieve.” In a few minutes, you will receive an email with your username and password. Once you are logged into your profile, you can change your password.
- Receipts & Invoices – NLPB’s Online Registrant Portal maintains all receipts created by the system. If for any reason, you need a receipt or to view an invoice, you can do so from your registrant profile. Once logged in, click on “Renewal Other/Invoices” and then select either “view invoice” or “print invoice” next to the one you are interested in.
This e-newsletter contains information on a wide variety of topics intended to enhance the practice of pharmacy in the province of Newfoundland and Labrador. As it is published and circulated to all registrants on a monthly basis, it is the expectation of NLPB that all registrants are aware of the matters contained therein.