REMINDER – Health Canada Regulations Regarding the use of Opioid Warning Stickers and Handouts Come into Force October 20, 2018
Canada’s Food and Drug Regulations were recently amended to require that a warning sticker and patient information handout be provided to patients, at the time of sale, with all prescription opioids that appear in Part A of the “List of Opioids”. These requirements come into force on October 20, 2018.
Both the warning sticker and the patient information handout must meet the specifications of the source document entitled ‘Information for Patients Concerning Opioids’, which is published on the Government of Canada’s website at: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/policies/warning-sticker-opioid-patient-information-handout/information-handout.html. Pharmacists and practitioners are responsible for obtaining or producing copies of the sticker and handout in order to meet these new requirements.
Opioids dispensed under the supervision of a practitioner, such as in a hospital setting, are not required to have a warning sticker and patient information handout. Opioids which are authorized and used for the treatment of an opioid use disorder are also exempt from this requirement, as specified on Part A of the “List of Opioids”, linked above.
To facilitate the successful implementation of these requirements, Health Canada has published a Guidance Document to assist impacted stakeholders. Please refer to this document for answers to questions related to these requirements.
Revised Standards for the Provision of Pharmaceutical Care to Personal Care Homes Now Posted!
Revised Standards for the Provision of Pharmaceutical Care to Personal Care Homes were approved by the board at their September meeting. The document is now posted on the Standards, Guidelines, Policies and Positions page of the website and will come into force on January 1, 2019. Key points in the Standards include:
- A Policy and Procedure Manual specific to personal care home service must be developed, regularly reviewed and revised, as needed.
- Both Medication Storage and Medication Safety audits must be completed at the personal care home at least once every 6 months.
- Any medication that is not packaged in a unit-dose or multi-dose package must be labelled with FULL instructions for use, as appropriate, including frequency, route of administration, interval and/or maximum daily dose, indication, and specific site of application, if applicable.
- Medication Administration Records (MARs) must be prepared for each resident on a monthly basis and delivered to the personal care home for review at least 4 days before the start of the next cycle.
- Staff at the home must be provided with sufficient education, including appropriate printed information, to ensure that they have an understanding of the medications that they are administering to patients.
- A pharmacist must conduct a comprehensive Medication Review for each resident at least annually.
The new Standards will be discussed during the October 15, 2018 Professional Practice Webinar, along with some other recently approved and revised NLPB documents. For more information on the webinar, visit the Professional Practice Webinars page of the website.
If you have any questions about the revised Standards, please contact NLPB office for guidance.
Assessing Buprenorphine/Naloxone Prescriptions
Even though dosing information is no longer included in the Standards for the Safe and Effective Provision of Opioid Agonist Maintenance Treatment (OAMT), pharmacists are reminded that they are still required to assess the appropriateness of buprenorphine/naloxone prescriptions.
As per Section 9.1 of the Standards, pharmacists must assess each buprenorphine/naloxone prescription to determine whether or not the dose, dosing schedule, and duration of prescription falls within recommendations outlined in the product monograph, clinical practice guidelines and standards of practice. If pharmacists receive prescriptions for buprenorphine/naloxone that are inconsistent with these references, they must consult with the prescriber, document the conversation and the rationale for their decision to dispense in the patient record.
All pharmacists who are currently authorized to participate in OAMT services are encouraged to complete the new NLPB program An Orientation to the Standards for the Safe and Effective Provision of Opioid Agonist Maintenance Treatment (available on the NLPB Online Learning Portal)to familiarize with the updated Standards and clinical practice guidelines.
Are Dosage Adjustments Within the Scope of Pharmacist Prescribing?
Recently, a number of registrants have asked whether or not pharmacists can make dosage adjustments to prescriptions, for example to discontinue a medication or to implement a tapering order. For clarification, “prescription adaptation”, as defined in the Authorization to Prescribe Regulations and the NLPB Standards – Prescribing by Pharmacists, does not include dosage adjustments, at this time. If a pharmacist identifies a drug therapy problem related to the dosage of a patient’s medication, they should contact the original prescriber or the patient’s primary health care provider to discuss recommendations and acquire a new prescription, where necessary.
Atlantic Mentorship Network-Pain & Addiction – Continuing Education Events
The Atlantic Mentorship Network – Pain & Addiction will be hosting 2 educational opportunities in Corner Brook, NL November 3 & 4, 2018:
- Pain Management & Addiction Medicine in Primary Care Conference: Saturday, November 3rd at the Glynmill Inn, Corner Brook. For details and registration please see https://www.eventbrite.ca/e/atlantic-mentorship-network-pain-addiction-conference-november-3-2018-tickets-41752739568
- The Prescribing Course-Safe Opioid Prescribing: Sunday, November 4th at the Glynmill Inn, Corner Brook. Information and registration can be found at http://www.bluesmartieconsulting.com/11_04_18.html
You can also visit their website www.atlanticmentorship.com for further information on these 2 events.
Proof of Continuous Insurance Coverage
In accordance with provincial legislation and the NLPB Policy – Professional Liability Insurance Requirements for Registration, all NLPB registrants are required to provide proof of continuous professional liability insurance coverage. Each year, when you renew your policy, you must upload an electronic copy of your new insurance certificate once you receive it. For instructions on how to do this, please click on the link How to Upload Documents.
If you have any questions about this requirement, please contact Aileen O’Keefe, NLPB Registration and Licencing Administrator at 753-5877, ext 201.
NLPB’s registration portal maintains all receipts created by the system. If for any reason you need a copy of your paid invoice, you can log in anytime by visiting www.nlpb.ca and clicking on “Registrant Login”. Once logged in, click on the link called “Renewal Other/Invoices” and then select either “view” or “print”.