Final Reminder for Pharmacy Technician Bridging Program Appeal Applications

This is a final reminder that applications for appeal to the Pharmacy Technician Bridging Program deadline must be received in the NLPB office no later than Friday, January 12, 2018.

To apply for the appeal, download and complete the Pharmacy Technician Registration Appeal form, posted on the Authorization & Registration Information For Registrants page of the NLPB website.

The Pharmacy Technician Appeals Committee will meet on January 15 to review the applications and make their recommendations to the Board at their meeting on February 2. Applicants will be notified individually of the decision after that date. Consideration will be given to candidates who demonstrate that they were acting in good faith to meet the registration deadline.

Questions Related to Physician Suspension / Withdrawal From Practice / Retirement

We are regularly asked by pharmacists whether or not they are able to continue to fill prescriptions from physicians who are no longer or not currently practicing. Of course, this question comes up even more frequently shortly after a physician passes away or retires, as it has recently. The following FAQ is posted along with many others on the Frequently-Asked Questions About Pharmacy Practice page of the website and is re-printed below for your convenience.

• How should I handle new prescriptions or requests for refills when a prescriber passes away, retires or otherwise ceases practice?

  Historically, it was felt that since the prescriber-patient relationship no longer exists and the patient is no longer under the practitioner’s care, the prescription should be no longer considered valid. However, this is not always practical in today’s world, since it can often take an extended period of time for a patient to obtain the services of another primary health care provider. In many cases, a prescriber will intentionally write prescriptions for a period of time that extends beyond his or her retirement to specifically cover off such situations.

  Technically, as long as the prescriber was licensed at the time the prescription was written, it can be assumed that the prescription was written in good faith. As such, as long as the prescription is not more than a year old, it would still be considered a legal prescription. The real question in this instance is whether filling or re-filling the prescription is appropriate – which needs to be assessed on case-by-case basis.

  Therefore, the Board advises pharmacists who receive such requests that it is their professional responsibility to evaluate the appropriateness of the prescription in each individual situation, considering questions related to patient assessment and the patient’s best interests. Questions to consider include, but are not limited to:

  • How long ago was the prescription written? Was it intended to be a short-term therapy?
  • Is the medication for a condition that is considered to be chronic or long-term? If so, does the patient have an established stable, compliant history with the medication?
  • Is the patient unable to visit a new primary health care provider in a timely manner?
  • Is the patient at an increased risk of harm by filling or refilling the medication? (Or conversely, is the patient at an increased risk of harm if the medication is not provided?)
  • If the prescriber was still practicing, would I have consulted with the prescriber for any reason before filling or refilling the medication?
  • Is there another option? Would providing an interim supply or prescription extension, be appropriate, if indicated?

  Regardless of the pharmacist’s decision, the patient should be advised to find a new or interim prescriber as soon as possible.

NL Pharmacy Board Awards – Call for Nominations

Nominations are now open for the NLPB Certificate of Recognition and Patient Safety Award. Details on the awards and a copy of the Nomination Form can be found at http://nlpb.ca/media/NLPB-Awards-and-Honours-Jan2017.pdf

These awards, along with the Emerald Achievement Award which recognizes NLPB registrants who have practiced pharmacy for at least 35 years, will be presented at the NL Pharmacy Board Awards Luncheon, taking place on May 12, 2018 during the NLPB Symposium.

Please consider nominating a fellow pharmacist or pharmacy technician today!

2018 Registration Statistics

As of January 2018, there are 719 registered pharmacists in the province. This includes 479 community pharmacists, 126 hospital pharmacists, 80 relief pharmacists, and 34 pharmacists who are classified as “other” which includes academia, government, consultancy, etc.

There are currently 212 licensed pharmacies in the province, of which 195 are community pharmacies and 17 are hospital pharmacies.

In 2015, NLPB registered three pharmacy technicians, followed by seven pharmacy technicians registered in 2016. In 2017, 135 pharmacy technicians were registered, with approximately 50 applications currently pending appeals.

Please Double-Check Your Contact information

Registrants are asked to ensure that the contact information they provide for themselves and the pharmacy is accurate at all times. The NLPB primarily uses email communication to send newsletters, renewal reminders, practice site assessment notifications and related paperwork, professional development audit information, calls for interest for committees, and other alerts (e.g. reports of lost or stolen TRPP pads). 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 at any time, please be sure to update your file with your new contact information at that time bu looking in to the Registrant Portal – you do not need to wait until the next renewal cycle.

Registrants are also reminded that they are obligated to check their email on a regular basis so that important notices do not go unread.

The Role of the Pharmacist When Dispensing Prescription Refills

Pharmacists are reminded that even when a pharmacy technician is performing the final technical check, pharmacists remain responsible for assessing the therapeutic/clinical appropriateness of drug therapy. This responsibility must be met for all prescriptions; whether new or refill (including those in compliance packages). A prescription CANNOT be released to a patient without a pharmacist having performed this assessment as well as provided counselling, as appropriate.

This responsibility is outlined in section 3.1 of the Standards of Pharmacy Operation – Community Pharmacy , which states that before a prescription is dispensed or a Schedule II medication is provided to a patient, it is the pharmacist’s responsibility to review the patient profile and patient medication profile and to take appropriate action, where applicable, with respect to:

• appropriateness of drug therapy;
• drug interactions;
• allergies, intolerances or adverse drug reactions;
• therapeutic duplication;
• correct dosage, route, frequency and duration of administration and dosage form;
• contraindicated drugs;
• patient adherence issues; and
• any other potential drug-related problems.

Similar, but slightly different, wording is included in section 3.3 of the Standards of Pharmacy Operation – Hospital Pharmacy.

This responsibility is further described in sections 1.11-1.14 of the Standards of Practice for Canadian Pharmacists, which states:

Pharmacists, when providing patient care as part of the care provided when dispensing medications or medication therapies:

• 1.11 assess the appropriateness of providing a refill of a medication requested by a patient by collecting and interpreting relevant patient information to ensure:
  • there are no significant drug interactions, contraindications or adverse effects, and
  • the medication is still required, and
  • the dose and instructions for use of the medication are correct, and
  • that the patient is receiving appropriate monitoring for this medication and disease.
• 1.12 manage patient’s requests for refills of medications which pose risks to the patient by:
  • making changes to the prescription in accordance with authorities granted to pharmacists by laws / regulations / policies / guidelines, and/or
  • contacting a prescriber to recommend changes in the prescription, and/or
  • refusing to dispense the medication.
• 1.13 assess patient’s compliance when providing refills for medications for treatment of chronic disease.
• 1.14 address problems with compliance that pose risks to the patient or can affect the efficacy of the medication by:
  • educating the patient, and
  • making changes to their medications and/or medication therapies in accordance with authorities granted to pharmacists by laws / regulations / policies / guidelines, or
  • contacting a prescriber to recommend changes in therapy.

NLPB Symposium – Registration Now Open!

Registration is now open for the 2018 NLPB Symposium, to be held at the Comfort Inn Airport in St. John’s on Saturday, May 12, 2018. The day will include the 2018 Annual General Meeting, a Professional Development Program, an Open Forum, and will end with the NL Pharmacy Board Awards Luncheon.

Registrants are invited to join us in:

• gaining knowledge and sharing experiences during our Professional Development programs and Open Forum;
• hearing about the Board’s activities over the past year during the Board’s Annual General Meeting; and
• celebrating our colleagues’ accomplishments at the NLPB Awards Luncheon.

To register for the symposium, click on “Registrant Login” on the main menu, log in using your username and password, and click the blue “Events” button located at the top of the Member Home screen. Once there, click on “View Upcoming Events” and then “NL Pharmacy Board Symposium” to complete the registration process.

We look forward to seeing you there!

Update on Nurse Practitioners’ Authority to Prescribe Buprenorphine-Naloxone and Methadone

In October 2017, the Council of the Association of Registered Nurses of NL (ARNNL) approved changes to the Nurse Practitioner scope of practice, permitting those Nurse Practitioners who have met specific practice and education requirements to prescribe buprenorphine-naloxone and methadone.

Subsequently, on February 5, 2018, ARNNL granted the first Nurse Practitioner authority to prescribe buprenorphine-naloxone. Information regarding which Nurse Practitioners have been granted authority to prescribe these medications will be available through ARNNL’s Member Search.

At this time, no Nurse Practitioners have been granted the authority to prescribe methadone as ARNNL is awaiting a section 56 exemption from Health Canada. A further update will be provided regarding Nurse Practitioner authority to prescribe methadone when the section 56 exemption is granted.

Reminders Regarding the Provision of Take-Home Naloxone Kits

Registrants are reminded that the NLPB has published guidance on the sale of naloxone in community pharmacies – http://nlpb.ca/media/Guidelines-Naloxone-Sept2016-revised-Feb2017.pdf. Pharmacists are expected to consider these guidelines when dispensing naloxone, in addition to meeting the usual expectations related to the provision of a Schedule II medication.

The guidelines also describe the expectations for the contents of a “naloxone kit” whether that kit be purchased from a distributor or assembled at the pharmacy itself. This includes:

• i) two 1 mL single-use ampoules or vials of naloxone hydrochloride 0.4mg/ml solution or two doses of naloxone hydrochloride 4mg/0.1ml nasal spray;
• ii) two 3cc syringes with auto-retractable 25G needles attached (1” length recommended) (for injectable naloxone);
• iii) alcohol swabs (for injectable naloxone);
• iv) latex or vinyl gloves;
• v) ampoule opening device (optional);
• vi) rescue breathing barrier with one-way valve (optional); and
• vii) step-wise instructions for recognizing and responding to an opioid overdose including written and visual instructions for administering naloxone administration.

Registrants are advised to follow best practices when verifying the contents of these kits when assembled, and again at the time of dispense and release to the patient.

Look-Alike / Sound-Alike – Xarelto and Xatral

A pharmacist recently reported that their pharmacy staff detected a “near miss” error between Xarelto (rivaroxaban) and Xatral (alfuzosin hydrochloride).

The Institute for Safe Medication Practices (ISMP) has issued a warning regarding the potential for this error in 2009 – https://www.ismp-canada.org/download/safetyBulletins/ISMPCSB2009-6-NationalCollaborative-Top5DrugsReported.pdf. They point out in the article (on page 4 of the bulletin) that this risk is particularly high since both products are available in 10 mg tablets, and both have a recommended daily dosage of 10 mg once daily. Additionally, since Xarelto is seen more often, there is the issue of “confirmation bias” where the mind sees what it wants to see, rather than what is actually there.

In order to mitigate the risk of this mix-up, ISMP advises health professionals to:

• use the generic name in addition to the brand name where applicable;
• include the indication for the medication when prescriptions are communicated;
• verify the indication for the drug with the patient whenever possible;
• clearly distinguish the 2 drugs in the product selection screen of computerized order entry systems; and
• add a warning where these drugs are stored.

Registrants are also encouraged to utilize independent double checks wherever possible, but particularly in relation to high-risk drugs – https://www.ismp-canada.org/download/safetyBulletins/ISMPCSB2005-01.pdf.

Photos of Prescriptions are Not Enough

The NLPB is aware that mobile apps allowing an individual to forward an image of their prescription to a pharmacy in advance of picking up their medication are currently available. We would like to advise our registrants that these images are not equivalent to an original prescription.

In the future, electronic prescribing will be available to help facilitate the transmission of a prescription directly from a prescriber to a pharmacy using the electronic health record, as required by legislation. Until that time, in order for the pharmacist or pharmacy technician to ensure that the prescription is authentic and clear and to allow the pharmacist to conduct an appropriate patient assessment, the original prescription must be obtained in person, or received via fax or verbally directly from the prescriber, in accordance with the Standards of Pharmacy Operation – Community Pharmacy, before being prepared and dispensed.

If an individual uses an app, text, or email to provide the pharmacy with a copy of a prescription, pharmacy team members may check their inventory to see if stock is available or offer an estimation on cost, but should not prepare the prescription before receiving the original, as this increases the risk of error and the possibility of creating inaccurate or duplicate records.

Reporting of Losses, Thefts and Forgeries

The Compliance Monitoring and Liaison Division of the Health Canada Office of Controlled Substances recently updated their guidance on reporting the losses, thefts and forgeries of controlled substances and precursors. Links to this guidance as well copies of the reporting forms can be found on the NLPB’s Professional Practice Resources page or on Health Canada’s website at: https://www.canada.ca/en/health-canada/services/health-concerns/controlled-substances-precursor-chemicals/controlled-substances/compliance-monitoring/loss-theft-forgery.html

Expectations When a Patient Receiving ODT Switches Pharmacies or Attends a Secondary Pharmacy

Pharmacists are reminded that, prior to dispensing methadone or buprenorphine-naloxone to a patient who previously attended another pharmacy, they need to speak with a pharmacist at the previous site to confirm the date, time, and dosage of the last dose. This information is necessary in order to assess the appropriateness of the prescription, and to determine whether it is safe to release the next methadone or buprenorphine-naloxone dose to the patient. Viewing the patient’s medication profile in the Pharmacy Network would not be sufficient to meet this expectation.

The Standards for the Safe and Effective Provision of Medication for the Treatment of Opioid Dependence state that “prior to releasing methadone or buprenorphine-naloxone to a patient, pharmacists are expected to review the patient’s profile and Administration Log for notes, missed doses, documentation of returned vials (if applicable), or any other applicable information.” If the Administration Log is located at another pharmacy, the pharmacist at the patient’s new pharmacy must confirm the details of the Administration Log with a pharmacist at the previous site. This would include instances where a patient is receiving continuation of methadone or buprenorphine-naloxone therapy in hospital. The Pharmacy Network profile does not contain the necessary specific details noted above, such as the time the patient received the dose and any noted concerns.

In addition, pharmacists are reminded that if a patient misses a dose of methadone or buprenorphine-naloxone, the dose should be cancelled on that day so that the patient’s medication profile contained within the Pharmacy Network is accurate with respect to the last date the patient received medication.

MUN School of Pharmacy Activities for Pharmacy Awareness Month

From ‘PAM’cake breakfasts, to testing seniors’ blood pressure, to educating high school students on the dangers of prescription drug abuse and beyond, MUN School of Pharmacy students have once again created a jam-packed calendar of activities for the month of March: Pharmacist Awareness Month (PAM).

For a schedule of events taking place throughout the month, see https://gazette.mun.ca/campus-and-community/think-pharmacists/ and follow the School of Pharmacy on Facebook and Twitter for PAM updates throughout March.

NL Pharmacy Board Awards – Call for Nominations

Nominations are now open for the NLPB Certificate of Recognition and Patient Safety Award. Details on the awards and a copy of the Nomination Form can be found at http://nlpb.ca/media/NLPB-Awards-and-Honours-Jan2017.pdf

These awards, along with the Emerald Achievement Awards recognizing NLPB registrants who have practiced pharmacy for at least 35 years, will be presented at the NL Pharmacy Board Awards Luncheon, taking place on May 12, 2018 during the NLPB Symposium.

The deadline to send in your nominations is March 9, 2018. Please consider nominating a fellow pharmacist or pharmacy technician today!

NLPB Symposium – Registration Now Open!

Registration is now open for the 2018 NLPB Symposium, to be held at the Comfort Inn Airport in St. John’s on Saturday, May 12, 2018. The day will include the 2018 Annual General Meeting, a Professional Development Program, an Open Forum, and will end with the NL Pharmacy Board Awards Luncheon.

Registrants are invited to join us in:

• gaining knowledge and sharing experiences during our Professional Development programs and Open Forum;
• hearing about the Board’s activities over the past year during the Board’s Annual General Meeting; and
• celebrating our colleagues’ accomplishments at the NLPB Awards Luncheon.

To register for the symposium, click on “Registrant Login” on the main menu, log in using your username and password, and click the blue “Events” button located at the top of the Member Home screen. Once there, click on “View Upcoming Events” and then “NL Pharmacy Board Symposium” to complete the registration process.

We look forward to seeing you there!

2018 NLPB Board Elections – Voting in Zone 1

Voting will open on Thursday, April 5, 2018 for the NLPB Zone 1 Board election. The election will be held through our secure, confidential elections portal.

To access the election portal, visit www.nlpb.ca and click on Registrant Login. Once logged in, click on the link called “View Candidates and Cast Your Vote”. The deadline for casting your vote is 11:59 pm, April 30, 2018. The successful candidate will be announced at the NLPB AGM, taking place on Saturday, May 12, 2018 during the NLPB Symposium.

If you have any questions, please do not hesitate to contact Meghan at mhandrigan@nlpb.ca.

Wellspring Pharmacy Leadership Awards

The Canadian Foundation for Pharmacy (CFP) is pleased to announce their ongoing commitment to advancing the profession of pharmacy, with a new grant of $10,000 for the Wellspring Pharmacy Leadership Awards.

While pharmacy revenues are being challenged, CFP sees the value in continuing to invest in the future of pharmacy through the development of our leaders.

These annual awards recognize both demonstrated and potential leadership in individuals in the pharmacy profession. Recipients receive up to $10,000 for initiatives that further develop personal leadership through study, experiential learning, or mentorship.

Candidates can nominate themselves or be nominated by others. Visit https://cfpnet.ca/grants-awards/details/award/36 for the criteria and application form.

Please send submissions for the 2018 awards by April 13, 2018, to submissions@cfpnet.ca.

NLPB Symposium – Only a Few Days Left to Register!

• Do you know how to respond to an online complaint?
• Should you accept a friend request from a patient?
• How can you best promote your pharmacy services online?

Learn more about the world of social media and how to handle these situations during our Social Media and Your Professional Reputation session at this year’s NLPB Symposium.

In addition to Professional Development session, the day will also include the 2018 Annual General Meeting, an Open Forum, and the NL Pharmacy Board Awards Luncheon.

For the full Schedule of Events, see the Symposium Program at: http://nlpb.ca/media/Symposium-Poster-2018-FINAL.pdf

To register for the symposium, click on “Registrant Login” on the main menu, log in using your username and password, and click the blue “Events” button located at the top of the Member Home screen. Once there, click on “View Upcoming Events” and then “NL Pharmacy Board Symposium” to complete the registration process.

We look forward to seeing you there!

New Standards for Pharmacy Compounding of Non-Sterile Preparations

The National Association of Pharmacy Regulatory Authorities (NAPRA) has released new standards on non-sterile compounding. Model standards represent the minimum requirements that must be met regardless of practice site and against which performance can be measured. Note that the model standards are accompanied by a guidance document that has been developed to provide direction on and assistance with implementation.

• Model Standards for Pharmacy Compounding of Non-Sterile Preparations
• Guidance Document for Pharmacy Compounding of Non-Sterile Preparations

The NL Pharmacy Board adopted the Standards and Guidance documents in principle at their meeting in February 2018 and committed to striking a committee to work towards establishing an appropriate implementation plan.

In advance of an implementation plan, all pharmacies and pharmacy professionals are encouraged to review the standards against their current practice to determine what may need to change in order to meet the standards. If you are unsure if you are performing non-sterile compounding, consider the following definition of compounding from Health Canada:

“The combining or mixing together of two or more ingredients (of which at least one is a drug or pharmacologically active component) to create a final product in an appropriate form for dosing. It can involve raw materials or the alteration of the form and strength of commercially available products. It can include reformulation to allow for a novel drug delivery. Compounding does not include mixing, reconstituting, or any other manipulation that is performed in accordance with the directions for use on an approved drug’s labelling material.”

Please watch The PostScript and other NLPB communications for more information regarding implementation in the coming months.

Health Canada Introduces New Rules for Pharmacies that Compound APIs for Veterinary Use

Do you provide pharmacy services for veterinarians or pet owners? If so, please note the following important information regarding federal regulation changes that may apply to you or your practice.

Regulatory changes to federal Food and Drug Regulations, meant to ensure the responsible use of antimicrobials in animals, may affect you if:

• You import active pharmaceutical ingredients (APIs) that are set out on List A: List of Certain Antimicrobial Active Pharmaceutical Ingredients; and/or
• You are a pharmacy professional who compounds antimicrobial drugs using APIs on List A: List of Certain Antimicrobial Active Pharmaceutical Ingredients for animal use.

The increased oversight on APIs for veterinary use require:

• manufacturing according to good manufacturing practices (GMPs);
• persons who fabricate, import, package, label and test active pharmaceutical ingredients (APIs) for veterinary use to hold a drug establishment license (DEL); and
• pharmacists, veterinarians or those compounding a drug under the supervision of a licensed veterinarian to hold a drug establishment license (DEL) when importing medically important antimicrobials that are on List A: List of Certain Antimicrobial Active Pharmaceutical Ingredients.

Therefore, as of May, 17 2018, you may need to:

• Be inspected by Health Canada,
• Comply with GMP, and/or
• Obtain a DEL (see below regarding transition period).

For more information on next steps and for resources provided by Health Canada on this subject, see the recent post on this subject, posted under Latest NLPB News.

Returning to Work After a Leave

Registrants are reminded that they are personally responsible for ensuring they are fully registered before returning to work after a leave of absence, including maternity or parental leave. This renewal should be initiated at least two weeks before the planned return to work date to allow for application processing.

To renew, the registrant must:

• Record a minimum of 15 continuing education units (CEUs) in the online Professional Development Learning Portfolio Record;
• Ensure they have professional liability insurance coverage in accordance with the NLPB’s Professional Liability Insurance Requirements for Registration;
• For pharmacists only: have current membership in the Pharmacists’ Association of Newfoundland and Labrador (PANL) as required by section 21(3)(a) of the Pharmacy Act, 2012; and
• Complete the online registration process and pay the appropriate fee.

Once all of these requirements are met, a registration certificate (“licence”) will be sent to the registrant’s personal email address on file.

Please Note: Pharmacists-in-charge are responsible for verifying that pharmacy staff members have completed these steps and are fully registered before beginning their first shift in the pharmacy, as required by section 12.(f) of the Pharmacy Regulations.

Please contact Aileen O’Keefe, Registration and Licensing Administrator at aokeefe@nlpb.ca or 709-753-5877 (extension 201) for further information.

Message from Health Canada

Health Canada is pleased to announce the release of two guidance documents:

• Guidance Document for Pharmacists and Dealers Licensed to Destroy Narcotics, Controlled Drugs or Targeted Substances – Handling and Destruction of Post-Consumer Returns Containing Narcotics, Controlled Drugs or Targeted Substances.
• Guidance Document for Pharmacists, Practitioners and Persons in Charge of Hospitals – Handling and Destruction of Unserviceable Stock Containing Narcotics, Controlled Drugs or Targeted Substances.

These are being released in support of the Controlled Drugs and Substances Act (CDSA), with the aim of mitigating the risk of diversion from the downstream supply chain. The guidelines streamline, update and clarify procedures, expectations and practices related to the handling and destruction of unserviceable stock and post-consumer medications by various parties regulated under the CDSA. Key changes include:

• The post-consumer returns guidance document sets out procedures for pharmacists involved in the collection, handling and destruction of unused or expired drug products containing a narcotic, controlled drug or targeted substance returned by an individual consumer;
• Health Canada will no longer require the recording of the name of the drug products associated with post-consumer returns. Consequently, the requirement to separate post-consumer returned controlled substances from other post-consumer returned prescription or non-prescription medications will no longer be in effect;
• The guidance documents require the treatment of post-consumer collection bins as if they contain controlled substances, regardless of the actual content. It is highly recommended that post-consumer returns are stored in single-use, one-way entry collection containers that are opaque, inconspicuous, tamper-evident and have a unique identifier;
• The guidance documents replace two Circular Letters (official notices sent to targeted stakeholders) previously sent to pharmacists, practitioners, persons in charge of hospitals, and dealers licensed to destroy narcotics, controlled drugs or targeted substances; and
• The unserviceable stock guidance document will set out procedures for practitioners, pharmacists and persons in charge of a hospital involved in the handling and destruction of these products.

The guidance documents will be considered effective in 6 months to allow the industry to accommodate these changes. Please note that an updated Section 56(1) exemption has been issued to accommodate for these changes.

Comments or questions about either of these documents should be directed to hc.compliance-conformite.sc@canada.ca.

Dose-Splitting of Lucentis, Eylea May Pose a Risk to Patient Safety

The NLPB is advising all pharmacy professionals that dose-splitting of single use Lucentis or Eylea vials may pose a risk to patient safety. Please view the following correspondence from the National Association of Pharmacy Regulatory Authorities (NAPRA) and Health Canada:

• NAPRA letter to Health Canada
• Health Canada’s response to NAPRA

Please be reminded that the Model Standards for Pharmacy Compounding of Non-Hazardous Sterile Preparations and the Model Standards for Pharmacy Compounding of Hazardous Sterile Preparations, developed by NAPRA, have been adopted as the standard for sterile compounding in Newfoundland and Labrador. These documents are posted on the Standards, Guidelines and Policies page of the website.

New MUN School of Pharmacy podcast – The Med Thread

From opium poppies to sleeping pills, from sucking to infusing, from insomnia, anemia, auto immune diseases and beyond – we discuss the threads that led to current trends and research in medication therapy. Listen to The Med Thread monthly, as we sew a patchwork quilt with squares of history, mythology, research, sciences and technological advances. The show is produced at CHMR studios in St. John’s, Newfoundland and Labrador. For information on how to access the podcast, visit The Med Thread webpage.

Revised Standards for the Safe and Effective Provision of Opioid Agonist Maintenance Treatment Now Available!

Revised Standards for the Safe and Effective Provision of Opioid Agonist Maintenance Treatment (OAMT) (formerly referred to as “Opioid Dependence Treatment”) were approved by the board at their May meeting and are now in effect. The document is available on the Standards, Guidelines, Policies and Positions page of the NLPB website. Key changes in the revised Standards include:

• Specific clinical information (such as dosing charts) has been removed from the document. Pharmacists should refer to the most recent clinical practice guidelines when assessing the appropriateness of an OAMT prescription.
• A section on ethical considerations has been added.
• For witnessed dosing of buprenorphine/naloxone, the witnessing of the dose is now considered complete at the point where the pharmacist has confirmed that the tablets have started to dissolve (which usually takes approximately 1-2 minutes).
• The hospital section has been expanded to provide clearer guidance to pharmacists providing continuation of OAMT in a hospital setting.
• A section has been added on the provision of slow-release oral morphine when used as a third-line agent for the purposes of OAMT. This section is based on the BCCSU clinical practice guidelines for opioid use disorder.

The Board encourages pharmacists to participate in treatment programs for opioid use disorder to the extent that is possible in their given practice environment.

A new orientation program has been developed to accompany the revised Standards. While this program will be available to all registrants to help familiarize them with the Standards, pharmacists who are not already authorized to participate in OAMT services will be required to complete the new program. It is anticipated that this program will be available by the end of July and registrants will be notified when it is available.

If you have any questions, please contact NLPB office for guidance.

Prescription Monitoring Program & Tamper Resistant Prescription Pad Program FAQs

Registrants are advised that a Prescription Monitoring Program (PMP) FAQ’s for Prescribers and Dispensers document was posted last week by the Department of Health and Community Services.

Additionally, a recent Newfoundland and Labrador Prescription Drug Program Bulletin (#93) answers some questions that were circulating regarding the impact that the implementation of the PMP and the inclusion of tramadol in that program would have on the Tamper Resistant Prescription Pad Program. That bulletin can be found on the Department of Health & Community Services Bulletins page. An updated list of the drugs included in the TRPP can be found at: http://www.health.gov.nl.ca/health/prescription/schedule_of_drugs_tamper_resistent.pdf

For more information or questions related to the Prescription Monitoring Program, please email info@PMPNL.ca.

For more information or questions related to the Tamper Resistant Prescription Pad Program, please call 1-709-729-6507 or 1-888-222-0533 or email healthinfo@gov.nl.ca.

Proof of Continuous Insurance Coverage

All NLPB registrants are required to provide proof of continuous insurance coverage. After your current policy expires, you must upload an electronic copy of your new certificate when 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 how to upload your policy, please contact Aileen O’Keefe, NLPB Registration and Licencing Administrator at 753-5877, ext 201.

NLPB Summer Hours

Please be advised that the NLPB office will be observing summer hours from Monday, June 6 to Friday, September 9, 2018.

During this time our hours of operation will be: 8:00 a.m. – 4:00 p.m. Monday to Friday.

Have a safe and happy summer!

Update on EpiPen

Please see the following information communicated by Health Canada regarding the EpiPen shortage issue.

Key messages:

• The Minister of Health has signed an Interim Order that will facilitate the import of AUVI-Q epinephrine auto-injectors into Canada as an emergency measure in response to the ongoing shortages of EpiPen (0.3 mg) and EpiPen Jr (0.15 mg).
• AUVI-Q is marketed by Kaléo in the U.S. and has been approved by the U.S. Food and Drug Administration. It is comparable to Allerject, another Kaléo epinephrine auto-injector product that is authorized, but not currently marketed, in Canada.
• Due to urgent need, AUVI-Q 0.3 mg will be available for order from McKesson Canada by the end of the week of August 27 (For contact information see Healthcare Professional Letter below). AUVI-Q 0.15 mg may be made available as required, depending on need and product availability.
• Both EpiPen and AUVI-Q deliver the same labelled dose of epinephrine. However, unlike EpiPen, AUVI-Q has a retractable needle as well as an electronic voice instruction system. (Currently, this is available in English only.)
• Pharmacists are reminded to:
  • Review the AUVI-Q product information with patients or caregivers. (English and French prescribing information, patient information, instructions for use, and trainer instructions are available at: www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements.html)
  • Distribute Patient Instructions for Use with each dispensed AUVI-Q auto-injector.
  • Use their discretion to conserve supply, as AUVI-Q is packaged such that each box contains 2 auto-injectors plus a trainer device (i.e., opening packages and dispensing single auto-injectors as necessary).
• Health Canada continues to work closely with suppliers, the provinces and territories, and stakeholders to help minimize the impact of this shortage on Canadians, with the goal of achieving an adequate, consistent and sustainable supply of authorized epinephrine auto-injectors in Canada as soon as possible.

Please also see the following links for additional information:

• News Release – Health Minister announces access to a U.S.-approved epinephrine auto-injector
• Interim Order Respecting Epinephrine Auto-Injectors
• Explanatory Note: Epinephrine
• Dear Healthcare Professional Letter
• Patient Information — Auvi-Q® (epinephrine injection) Auto-Injector For Allergic Emergencies (Anaphylaxis)
• FAQ developed by Food Allergy Canada regarding the supply of Auvi-Q in Canada

Pharmacists with prescribing authority are reminded that they can help their patients manage this switch by prescribing the new product (as a Schedule II medication) or by adapting a patient’s existing prescription.

NLPB Launches Online Learning Portal

This past week, the Newfoundland and Labrador Pharmacy Board launched its online learning portal with two Standards of Practice Orientation Programs – An Orientation to Prescribing by Pharmacists in Newfoundland and Labrador and An Orientation to the Standards for the Safe and Effective Provision of Opioid Agonist Maintenance Treatment. The intention is to add other programs and learning opportunities to the portal over time.

In order to access these programs, visit https://learn.nlpb.ca/ to create an account. Once your account has been created and approved, click on “Available Courses” to select a program to complete.

Once the program is completed, print your certificate of completion and follow the usual processes to apply for authorization, if required.

If you have questions about the NLPB Online Learning Portal, please email learn@nlpb.ca

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.

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.

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.

Registration and Licensing Renewal Now Open!

Annual renewals for the 2019 registration year have begun. An email has been sent to all registrants and pharmacists-in-charge with instructions on how to renew.

REMINDERS:

• The deadline for renewals (including payment) is November 30, 2018. PLEASE NOTE that a late fee will be automatically applied after November 30.
• Registrants are advised to have all necessary information handy before beginning the online renewal process. Once the renewal is started it cannot be saved and resumed. Additionally, after two hours, the system will automatically log you out.
• Pharmacists-in-Charge should be prepared to provide ownership information for the pharmacy.
• Registrants will be asked to upload proof of professional liability insurance, in the form of a certificate of insurance obtained from their insurance provider. This document should bear the carrier name, policy number and expiry date for their policy. A user guide on how to upload the certificate can be found in the Library Section of your Member Home page.
• Registrants with Authorization to Administer Injections will be asked to upload proof of their current CPR/First Aid certification. This document should bear the registrant’s name, the level of certification and the expiry date of the certification.
• Once the renewal is completed and paid, to print your receipt, please click View/Print Invoices and select the paid invoice as proof of payment.
• 2019 pharmacy licences will be mailed to each pharmacy and a certificate of registration will be emailed to each registrant who has renewed for 2019 in December, after the renewal period has ended.
• If you forget your username and/or password, click Registrant Login. Under “Forgot your username/password”, enter the email address associated with your profile. Your login information will be emailed to you shortly. Once logged in, you can change your username and password to something easier for you to remember.

New Reporting Requirements for Medical Assistance in Dying Now in Effect

All registered pharmacists are advised that new federal reporting requirements for medical assistance in dying (MAiD) came into effect on November 1, 2018.

In accordance with Health Canada legislation, pharmacists who have dispensed a substance in connection with the provision of MAiD are required to report to Health Canada within 30 days after the day of dispensing. Pharmacists must report:

• Patient’s date of birth, health insurance number and province of issuance
• Your name, province or territory of practice, licence or registration number, mailing address and e-mail
• Name and licence or registration number for the practitioner who prescribed or obtained the substance
• The date that the substance was dispensed and where it was dispensed (hospital or community pharmacy)

Pharmacists in NL will report this information directly to the Federal Minister of Health through the Canadian MAID Data Collection Portal developed jointly by Health Canada and Statistics Canada. Screening questions on the site will guide you to the relevant questions for your scenario.

The link to this portal as well as additional information regarding this change will be available on the “Reporting requirements for medical assistance in dying” page on the Government of Canada website.

Changes to NLPB Prescribing Standards to Reflect Revisions to TRPP Program

Registrants are advised that the NLPB Standards of Practice – Prescribing by Pharmacists has been updated to include an additional statement in section 3 – Limitations, which states: “A pharmacist may not prescribe a drug included on the list of drugs referenced in section 4.(1) of the Pharmaceutical Services Regulations – i.e. the ‘Drugs Required to be Written on Tamper Resistant Pads'”.

This change was necessitated by the recent addition of tramadol to this list of drugs.

In practicality, this change means that pharmacists MAY NO LONGER perform prescribing activities for tramadol, including providing an interim supply, extending a prescription or adapting a prescription.

The full Standards document, including the change can be found on the Standards, Guidelines, Policies and Positions page of the website, under “Provincial Standards of Practice”. If you have any questions about the revised Standards, please contact the NLPB office for guidance.

NLPB Practice Policy – Registrant Use of Social Media

Registrants are reminded that in May of 2018, the NL Pharmacy Board approved a new Practice Policy regarding Registrants’ Use of Social Media. This policy was implemented in recognition of the expanding use of social media use among pharmacy professionals and the many opportunities for information-sharing in a registrant’s personal and professional life.

In the policy, registrants are reminded that the expectation of professional and ethical conduct is the same whether they are interacting with others in person or through social media, and whether they are interacting in a personal or professional context. Additionally, when using social media, registrants are expected to:

• Apply all practice and ethical standards in the same manner while using social media as required for direct person-to-person interactions.
• Keep all personal health information and any other information that identifies, or could potentially identify, a patient strictly confidential. This includes any information that could allow a patient to recognize him or herself.
• Maintain clear and appropriate boundaries with patients, and consider the appropriateness of establishing personal connections with them.
• Avoid offering personal health-related advice via social media.
• Avoid posting any content, including personal information, images, and opinions that could be viewed as unprofessional or detrimental to the profession.
• Refrain from engaging in any interaction that is, or could be considered, harassing in nature towards any individual or group.
• Keep in mind that tone and context can be easily misinterpreted in social media contexts.
• Recognize that inappropriate use of social media may result in disciplinary action from the NLPB, disciplinary action from the registrant’s employer, civil liability, or prosecution. Posting content anonymously, under a pseudonym, or from a personal account does not protect the registrant from the potential consequences of inappropriate activity.
• Abide by the duty to report outlined in the Pharmacy Act, 2012 and report any knowledge of a breach of this policy on the part of any registrant.

The policy can be found on the Standards, Guidelines, Policies and Positions page of the NLPB website, under “Pharmacy Practice Policies”.

“Pharmacy Technician” – A Restricted Title

Registrants, pharmacists-in-charge and pharmacy owners are reminded that, in accordance with the Pharmacy Act, 2012, use of the “pharmacy technician” designation is restricted and protected. Only those registered with the NL Pharmacy Board as pharmacy technicians may use this title or be referred to pharmacy technicians. If you employ other unregulated support staff in your pharmacy, they may be called “pharmacy assistants” or be given another title.

NLPB Season’s Greetings and Christmas Hours

As the year draws to an end and the Christmas Season approaches, we take this opportunity to wish you a very Merry Christmas and a Happy New Year. Best Wishes from the Board Members and Staff of the Newfoundland and Labrador Pharmacy Board.

In recognition of the Christmas and New Year holiday season, the Board office will be closed from Monday, December 24th to Tuesday, January 1st, inclusive.

If you need assistance during this time, please email inforx@nlpb.ca

Injection Standards Reminders

With the flu shot season at its peak, it is timely to remind pharmacists of the following standards and policies related to the administration of injections and inhalations:

• In accordance with the NLPB Policy – Pharmacy Students / Interns Administering Inhalations or Injections, pharmacy students and interns may administer drugs by inhalation or injection only if they:
  • are registered with the NLPB (including maintaining appropriate professional liability insurance);
  • have successfully completed either an education and training program on the administration of injections that has received CCCEP competency-based (stage 2) accreditation OR all education and training on the administration of injections are part of the pharmacy program core curriculum;
  • have current certification in CPR Level C or HCP and Emergency or Standard First Aid from a recognized provider (e.g. St. John Ambulance, the Canadian Red Cross); and
  • are under the direct supervision of a pharmacist who has received authorization from the NLPB to administer drug therapy by inhalation or injection. In this context, when providing “direct supervision”, the pharmacist must be present when the activity is being performed and be able to observe and promptly intervene and stop or change the actions of the individual being supervised.
• In accordance with the Standards for the Safe and Effective Administration of Drug Therapy by Inhalation or Injection, pharmacists are reminded of the following documentation and notification requirements:
  • a Documentation and Notification Form must be completed and retained as part of the patient’s pharmacy record;
  • a copy of the Documentation and Notification Form must be provided to the patient for their records;
  • the inhalation or injection administration must be properly recorded in the provincial electronic health record; and
  • other regulated health professionals may be notified, as appropriate, but it is not required.

SaferMedsNL: Improving Medication Use Across Newfoundland and Labrador

The Department of Health and Community Services, Memorial University, and the Canadian Deprescribing Network are currently developing a deprescribing project entitled SaferMedsNL. The goal of this initiative is to decrease the use of potentially inappropriate medications and improve the quality of life of Newfoundlanders and Labradorians.

SaferMedsNL is a three-year initiative that will focus on reducing the inappropriate use of proton pump inhibitors in year one, sedative-hypnotics in year two and opioids in year three. SaferMedsNL aims to increase public awareness of the benefits and harms of these medications, and facilitate meaningful conversations between healthcare providers and patients to ensure medications are continued when necessary and stopped when they are no longer necessary.

Through SaferMedsNL, both healthcare providers and patients will have access to evidence-based tools and resources to facilitate approaches to deprescribing, improve both patient and healthcare provider competency for reducing inappropriate medications, and provide opportunity for deprescribing via meaningful discussions between healthcare providers and patients.

SaferMedsNL will officially launch in January 2018. In the coming weeks more details will be provided on the inventory of resources and tools available to healthcare providers to mobilize knowledge and promote deprescribing across Newfoundland and Labrador.

“Pharmacy Technician” – A Restricted Title

Registrants, pharmacists-in-charge and pharmacy owners are reminded that, in accordance with the Pharmacy Act, 2012, use of the “pharmacy technician” designation is restricted and protected. Only those registered with the NL Pharmacy Board as pharmacy technicians may use this title or be referred to pharmacy technicians. If you employ other unregulated support staff in your pharmacy, they may be called “pharmacy assistants” or be given another title.