The PostScript Archives 2015

Schedule II Reminder

In light of the recent CBC Marketplace investigation, pharmacists are reminded of their professional responsibility when dispensing medications in Schedule II of the Provincial Drug Schedules.

Even though Schedule II medications are less strictly regulated than Schedule I (prescription only) medications, they do require the professional intervention of the pharmacist at the point of sale. These medications must be retained within the professional services area of the pharmacy where there is no public access and no opportunity for patient self-selection. Pharmacists must make the decision to recommend the treatment of Schedule II medications based on patient consultation and due diligence in the identification of potential drug interactions. Our standard practice expects the pharmacist to engage with the patient in determining whether or not what is being requested is appropriate and to counsel on the potential side effects. The best practice when providing a Schedule II product is to record the medication on the pharmacy’s practice management system to check for possible interactions with the patient’s medication profile, and if available, their Pharmacy Network profile.

2014 Professional Development Audit

Notification regarding the 2014 Professional Development Audit was sent out by email on Friday, January 30, 2015. If you were selected for the audit, please submit photocopies of relevant supporting documentation for each activity listed on your online Learning Portfolio Record. Generally, for accredited programs, this is a record of participation or statement of completion. For self-assigned CEUs, program brochures, presentation outlines or any other materials that reflect the content of the learning activity can be utilized. All material must be received by the NLPB office no later than February 20, 2015. Please note, faxed copies will not be accepted.

For further information on the Professional Development Audit process, please see the Standards of Practice – Professional Development for Pharmacists and Pharmacy Technicians on the Standards, Guidelines and Policies page of the NLPB website.

REMINDER – Preceptor Training and Authorization Now Required

As previously communicated in the November 2014 issue of The PostScript and the Winter 2014 issue of The Apothecary, Board-approved preceptor training is now required for pharmacists applying to be a preceptor to pharmacist and pharmacy technician candidates who are participating in the Board’s Practical Training programs.

In partnership with MUN School of Pharmacy, the Board has endorsed the online preceptor training modules found at http://www.mun.ca/pharmacy/community/spe/preceptorcriteria.php. Note that the Dalhousie program is accredited for CEUs and may be used toward your annual Continuing Professional Development requirement.

Following completion of the education program, the pharmacist must apply to the Board for authorization to act as a preceptor by completing the Application for Authorization to Serve as a Preceptor found on the Registration and Authorization page of the NLPB website.

We encourage all pharmacists to consider supporting the development of the profession by helping shape the next generation of pharmacists.

Pharmacies that offer Opioid Dependence Treatment Services are in Demand

New Standards for the Safe and Effective Provision of Medication for the Treatment of Opioid Dependence (available on the Standards, Guidelines and Policies page of the NLPB website) came into effect on January 1, 2015. The Provincial Advisory Committee for Opioid Treatment Services has indicated there is a shortage of community health practitioners in this field, limiting patient access to treatment. Please consider contacting NLPB for more information about requirements surrounding methadone and buprenorphine-naloxone dispensing and advice on how to incorporate this important area of practice into your current pharmacy services.

Deactivating “Old” Prescriptions to Prevent “Wrong Dose”or “Duplicate Therapy” Errors

Patients who have chronic conditions often have changes to their drug therapy over time. Pharmacists are reminded that it is important to use the most recent prescription for a drug therapy when processing refill requests. Previously written prescriptions that still have refills remaining should be deactivated in the patient’s medication profile at the time a new prescription is received, so that “old” prescriptions cannot be dispensed in the future. When there are a number of active prescriptions for the same drug on a patient’s profile there is a potential for dose error or duplication in therapy. It is imperative that pharmacists communicate clearly with patients, both verbally and in writing, when changes are made to their prescribed medications.

Registration by the Numbers

As of January 2015, there are 675 registered pharmacists in the province. This includes, 527 community pharmacists, 107 hospital pharmacists and 41 pharmacists who are classified as “other” which includes academia, government, consultancy, etc. Of the 675 pharmacists, 70 are classified as “relief”.

There are currently 208 licensed pharmacies in the province, of which 192 are community pharmacies and 16 are hospital pharmacies.

There are now 141 pharmacists authorized to administer inhalations or injections to their patients. At this time, this is still limited to the influenza vaccine. For information on the requirements for authorization, please see the Standards for the Safe and Effective Administration of Drug Therapy by Inhalation or Injection, available on the Standards, Guidelines and Policies page of the NLPB website. To apply for authorization, visit the Registration & Authorization Information page of the website and complete the Application for Authorization to Administer Injections.

The regulation of Pharmacy Technicians is quickly becoming a reality in this province. On February 2, 2015 four pharmacy technician applicants successfully wrote the NLPB Registration Exam. The Board is looking forward to welcoming these new practitioners to the profession.

Changes to the Provincial Drug Schedules

Pharmacists are advised that at the February 21, 2015 meeting, the Board approved the following changes to the Provincial Drug Schedules:

To reflect the NDSAC recommendation of June 17, 2014, which was finalized on July 18, 2014:

• Added to Schedule II: “triamcinolone acetonide in an aqueous nasal spray that delivers 55mcg per metered spray for adults and children 12 years of age and older, in package sizes containing more than 120 metered sprays”
• Added to Schedule III: “triamcinolone acetonide in an aqueous nasal spray that delivers 55mcg per metered spray for adults and children 12 years of age and older, in package sizes containing no more than 120 metered sprays”

The updated Drug Scheduling documents and a notice of this change are posted on the Provincial Drug Schedules page of the NLPB website.

Practice Hours Audit

As communicated in the December PostScript, the Board will begin auditing the self-declarations that pharmacists make at the time of registration renewal. The first of these to be audited is Practice Hours. In the near future, the Board will notify selected pharmacists to provide proof that they have worked a minimum of 420 hours in the past two calendar years.

If you are selected for audit, you are required to send evidence that supports your declaration that you have met this requirement for registration. A form will be provided for your employer(s) to complete. If this is not feasible, alternative forms of proof may be submitted including pay-stubs, records of employment or tax records. Following review of the documentation provided, you will be notified by email of the results.

Opioid Dependence Treatment Standards Update

The new Standards for the Safe and Effective Provision of Medication for the Treatment of Opioid Dependence (available on the Standards, Guidelines and Policies page of the NLPB website) have been in effect for about 2 months now. As we hear feedback regarding usability of the Standards and receive questions from pharmacists, other health professionals and stakeholders, sections of the Standards that require clarification are noted.

Specifically, at this time, NLPB would like to highlight the following:

• Section 3- Pharmacist Requirements for Participation in Medication-Assisted Opioid Dependence – NLPB is pleased to provide an update that an education program on opioid dependence treatment and the new Standards will be available online to pharmacists late March. As a reminder, pharmacists must complete an education program approved by NLPB by November 30, 2015 and submit proof of successful completion with registration renewal.
• Section 5.4 d) Practice Standards for Participation in Methadone Maintenance Treatment – “Preparing Take Home Doses” specifies the use of appropriately-sized bottles with both child- and tamper-resistant caps. The use of tamper-resistant caps facilitates the implementation of carry audits should they be requested at the discretion of the physician or pharmacist. Carry dose audits can be utilized as a strategy to prevent diversion of dispensed carries.
• Section 5.6 c) and Section 6.6 b), Responding to Special Circumstances – “Missed Doses” indicates that pharmacists MUST report ANY missed doses of opioid dependence treatment (methadone or buprenorphine-naloxone) to the physician within 24 hours so that the physician can reassess the patient’s clinical stability. This includes the reporting of missed doses during voluntary and involuntary tapers. It has been reported to NLPB that physicians may not be receiving notification regarding missed doses for some of these patients.

A “State-of-Practice Survey” for Pharmacies Participating in Opioid Dependence Treatment Services has been sent to pharmacists-in-charge of relevant practice sites. The deadline for submission of the survey has been extended to March 13, 2015. If you have received a request to participate in this survey and are no longer offering such services, please contact NLPB to update the pharmacy’s profile. If you have not received this survey and are planning to incorporate this important area of practice into your current pharmacy services, please contact NLPB to arrange access.

Pharmacy Student or Intern Administration of Drug Therapy by Inhalation or Injection

With MUN SPE placements and NLPB Internships taking place over the next few months, pharmacists are advised of the following policy regarding pharmacy students or interns administering drugs by inhalation or injection.

Prior to administering any drug by inhalation or injection, the pharmacy student or intern MUST:

• be registered with the NLPB, and be completing either the Internship portion of the NLPB Practical Training program, or a clinical placement as part of the Memorial University Pharmacy Program;
• 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
• be under the direct supervision of a pharmacist who has received authorization from the NLPB to administer drug therapy by inhalation or injection.

For future reference, this policy is also posted to the Frequently Asked Questions About Pharmacy Practice page of the NLPB website.

INSTEP, the new Online NLPB Practical Training Process

The NLPB is pleased to announce that starting April 2nd, the student and intern practical training experience will be available online at nlpb.ca. The program is designed to improve both the application process and the evaluation/validation process for both students/interns and preceptors.

When a student or intern is applying for practical training, he or she will log in to their online profile and identify their preceptor from a list of approved preceptors. That person will then be notified to approve the application. This process will take the place of completing and submitting paper forms. This will be especially helpful when distance is a factor as the profile is accessible from anywhere by internet.

Watch for more information about this latest addition to our online registrant portal.

The Institute for Safe Medication Practices Canada (ISMP Canada)

The Institute for Safe Medication Practices Canada (ISMP Canada) is informing Canadian pharmacists of important information available on their consumer reporting and learning website, SafeMedicationUse.ca. Through this website, consumers can report medication incidents and get information about using medications safely. Many reports received by SafeMedicationUse.ca describe incidents that occur in pharmacies, in hospitals and at home. SafeMedicationUse.ca publications contain important safety information for pharmacists, including “Tips for Practitioners” designed to help prevent the types of incidents reported by consumers.

ISMP Canada would also like to draw your attention to important information about the contact lens cleaning solution Clear Care. Clear Care solution contains 3% hydrogen peroxide, and should not be used directly in the eye or as a rinsing solution for lenses. SafeMedicationUse.ca continues to receive reports from consumers who have experienced pain and burning in the eyes after confusing Clear Care with a multi-purpose contact lens solution. Due to the number of incident reports we have received, and that fact that many of the incidents resulted in corneal burns requiring emergency care, we believe that additional steps are needed to make consumers aware of the need to check labels of contact lens solutions carefully.

ISMP Canada has made the following recommendations that are of importance for pharmacists:

• Do not display hydrogen peroxide–based contact lens cleaning solutions beside multi-purpose solutions.
• In community pharmacies, consider storing hydrogen peroxide–based solutions behind the counter.
• Before selling or recommending hydrogen peroxide–based contact lens cleaning solutions, confirm the intended use of the product and educate consumers about proper use.
• Share the latest SafeMedicationUse.ca Clear Care alert with consumers and patients. Consider posting a copy of the alert near displays of hydrogen peroxide–based lens cleaning solutions.

We encourage you to review the Clear Care alerts and other alerts and newsletter on the SafeMedicationUse.ca website. To receive the latest publications from SafeMedicationUse.ca, please: sign up to receive email communications on the home page, like SafeMedicationUse.ca on Facebook and follow @SafeMedUse on Twitter. For more information, you may contact info@ismp-canada.org.

Update on Pharmacy Technician Registration

The Board is now registering Pharmacy Technicians and is currently working on revising the Standards of Pharmacy Operation and Standards of Practice to recognize this new category of registrant and clarify the role of the Pharmacy Technician within the profession. As such, it is timely to communicate a couple of reminders:

Prescription Transfers

All pharmacists are reminded that, in accordance with Federal legislation (C.01.041.1 – C.01.041.3 of the Food and Drug Regulations), only Pharmacists or Pharmacy Technicians registered with the Board may participate in prescription transfers. Pharmacy Assistants may NOT participate in requesting transfers and may only participate in the clerical aspects of sending a transfer – for example, print a prescription copy suitable for fax once the pharmacist or pharmacy technician has authorized the transfer and faxing the copy to the requesting pharmacy.

Identification – Name Tags and Telephone Protocols

Pharmacists in charge are reminded that, in accordance with section 24.(2) of the Pharmacy Act, 2012, only those registered as a Pharmacy Technician with the NLPB may be identified or identify themselves as such. Other unregulated staff members may be referred to as Pharmacy Assistants or another suitable title.

If you would like to know more about the Pharmacy Technician registration process, visit the Pharmacy Technician Registration Information page of the NLPB website and sign up for our contact list by emailing your name and email address to: inforx@nlpb.ca.

Update on Issues Related to the Opioid Dependence Treatment Standards of Practice

Opioid Dependence Treatment Education Program Now Available

We are pleased to announce the launch of “Optimizing Opioid Dependence Treatment,” an education program developed specifically with the NLPB Standards for the Safe and Effective Provision of Medication for the Treatment of Opioid Dependence and NL pharmacists in mind. The program is available on the Advancing Practice website and can be accessed via the Professional Development page of the NLPB website or by visiting the following link: http://www.advancingpractice.com/p-84-optimizing-opioid-dependence-treatment.aspx. The program is divided into a series of modules that may be completed in one sitting or over the course of several sittings, whatever is most convenient. The program cost is $100 + HST and the program has been accredited by NLPB for 4.5 CEUs.

Pharmacists are reminded that this program is a component of the mandatory authorization process for any pharmacist working at a site that participates in Opioid Dependence Treatment services, including relief pharmacists.

Once the program is completed, the pharmacist can apply for authorization using the Application for Authorization to Participate in Opioid Dependence Treatment Services posted on the Registration and Authorization Information for Registrants page of the NLPB website.

Administration of Opioid Dependence Treatment

As per section 5.5 a) and 6.5 a) of the Standards, authorized pharmacists must administer and witness ingestion of methadone and buprenorphine-naloxone doses. This function may not be delegated to a pharmacy technician, pharmacy student or any other member of the pharmacy team. Pharmacy students can gain experience in patient assessment and provision of opioid dependence treatment through observing pharmacists during each stage of the opioid dependence treatment workflow- such as collaborating with prescribers, establishing a patient-pharmacist relationship, assessing the prescription, preparing witnessed and take-home doses, assessing the patient for signs of toxicity, administering witnessed doses, releasing take-home doses, etc.

Methadone Tablets

Standards for the Safe and Effective Provision of Medication for the Treatment of Opioid Dependence apply specifically to the use of methadone and buprenorphine-naloxone for the treatment of opioid dependence. These Standards do not apply to the prescribing and dispensing of these medications for pain.

When used for the treatment of opioid dependence, methadone must be dispensed using an unflavoured, commercially-prepared 10 mg/ml methadone solution (e.g. Methadose) that is diluted to 100 ml with crystalline juice. The only exception to this is when such a commercial product is not available. If this situation occurs, methadone stock solution may be compounded to a strength of 10 mg/ml and diluted accordingly. In both instances, methadone is provided in such a way that it is not conducive to misuse and overdose through snorting or injecting.

Therefore, the dispensing of methadone tablets for the treatment of opioid dependence (for example, for take-home doses during times of travel) is not supported by NLPB Standards. Methadone tablets should only be dispensed when prescribed by an authorized physician exclusively for the treatment of pain.

To view the Standards in their entirety, visit the Standards, Guidelines and Policies page of the NLPB website.

Filling Prescriptions from Out of Province Prescribers

We often get questions from pharmacists regarding whether or not they can fill a prescription written by a prescriber licensed in another province of Canada. Section 26 of the Act addresses out of province prescriptions. It reads as follows:

• 26. A pharmacist may dispense a drug pursuant to a prescription authorized by a prescriber licensed to practice in a province or territory of Canada other than Newfoundland and Labrador if the pharmacist has taken reasonable steps to ensure that
• (a)the prescriber is licensed and practises in Canada ; and
• (b)the prescriber belongs to a class of persons who, if licensed in Newfoundland and Labrador, would be entitled by law to prescribe that drug in Newfoundland and Labrador.

Therefore, a prescription written by a pharmacist in Alberta or a chiropractor in Ontario would not be considered “valid” in our province as pharmacists and chiropractors in NL currently do not have prescriptive authority.

Additionally, if the prescription is for a narcotic or controlled drug covered by the Tamper Resistant Prescription Drug Pad Program, then the prescription MUST be written on the appropriate tamper resistant pad, regardless of whether or not the prescriber is licensed in NL. For more information on this program, visit the Department of Health and Community Services website at: http://www.health.gov.nl.ca/health/prescription/hcp_tamperresistantdrugpad.html

NLPB Quality Assurance Program Update – Community Pharmacy Practice Site Assessments

It’s that time of year again to take the show on the road! Starting this month, the Board will be traveling across the province to conduct practice site assessments in community pharmacies.

In April 2014, the Board launched a Community Pharmacy Assessment Program in support of the Quality Assurance component of the Pharmacy Act, 2012. We are pleased to announce that, to date, 33 pharmacies have undergone the assessment process.

Communication throughout the assessment process is primarily with the pharmacist-in-charge of a given pharmacy. The pharmacist-in-charge is contacted in advance of a scheduled assessment to confirm the date and time for the assessment. Practice site assessments generally take about half a day to complete- depending on the number of expanded services a pharmacy offers and the presence of additional staff on assessment day. The pharmacist-in-charge is asked to complete a “Community Pharmacy Self-Assessment” and return it to the Board in advance of the on-site assessment. During the on-site assessment, the NLPB assessor will confirm items that were self-declared, review NLPB Standards of Practice in detail, and discuss pharmacy best practices. Professional image of the pharmacy and workflow are also evaluated. Following the on-site assessment, the pharmacist-in-charge is provided a summary report that includes a list of any areas requiring attention as well as suggestions and tools to better pharmacy practice and enhance professional image. The pharmacist-in-charge is required to respond to NLPB to confirm that necessary changes have been made at the pharmacy or provide an action plan for when required changes will take place. All communication related to a pharmacy assessment becomes a permanent part of a pharmacy’s file at the Board. Upon implementing any necessary changes and successfully completing the practice site assessment, the pharmacy is given a “Certificate of Assessment” that is intended to be displayed in a public area of the pharmacy to showcase excellence in pharmacy care.

While NLPB aims to take a “working together” approach throughout the process, it is important to note that pharmacy assessments are mandatory and going forward all pharmacies will be assessed at least every 3-5 years. The Board thanks pharmacists for their cooperation. By implementing a Quality Assurance program, the public can be assured of the professions’ commitment to patient safety and advanced pharmacy service.

PEBC Pharmacy Technician Qualifying Exam Available in NL Starting in Summer 2015

The NLPB is happy to report that Parts I and II of the PEBC Qualifying Exam will be offered in St. John’s, NL beginning in the Summer of 2015.

Please be advised, however, that, as with all PEBC Exam sittings, availability is subject to PEBC meeting their registration minimums. If there are insufficient registrants for either Part, PEBC reserves the right to cancel the sitting. The sittings and deadlines are as follows:

• Pharmacy Technician Qualifying Exam Part I – Sitting: September 12, 2015 – Deadline for application: June 10, 2015
• Pharmacy Technician Qualifying Exam Part II – Sitting: September 13, 2015 – Deadline for application: June 10, 2015

For more information on the Qualifying Exam, visit PEBC at: www.pebc.ca

Reporting Renovations

Pharmacists in Charge are reminded that they are responsible for completing and submitting an Application for Renovation of an Existing Pharmacy/Dispensary at least 15 days prior to initiating any renovations to the pharmacy that affect the dispensary or the professional products area. Included with the application should be a detailed diagram indicating the proposed changes and the appropriate fee. A site assessment may be required with a Self-Assessment of the renovated pharmacy/dispensary to be completed by the Pharmacist-in-Charge and submitted to the Board in advance of the visit. Please see the NLPB Requirements for Renovating an Existing Pharmacy/Dispensary, available on the Licensing Information for Pharmacies page of the NLPB website for more information.

Tip: Remember to advise the NLCHI Pharmacy Network of the renovation to ensure continuous connectivity.

Professional Liability Insurance

In the interest of public protection, registrants are reminded that as per section 14 (c) of Pharmacy Act 2012, they are required to maintain professional liability insurance in accordance with NLPB’s Interpretation Guide – Professional Liability Insurance Requirements for Registration. It is the requirement of the individual registrant to ensure their insurance meets these requirements.

MUN School of Pharmacy Graduates

On April 21, 2015 NLPB was pleased to host a “Welcome to the Profession” Luncheon for Memorial University School of Pharmacy graduating students who wrote the NL Registration Examination. Hosted by Board Chair, David Cramm, participants were also presented with a welcome keepsake from the Board. Going forward, we hope to continue this tradition with new registrants.

New Standards of Pharmacy Operation Approved for Community Pharmacies

As communicated to all Pharmacists-in-Charge via email on June 30, 2015, at a recent meeting of the Board, new Standards of Pharmacy Operation for Community Pharmacies were approved and are currently posted on the Standards, Guidelines and Policies page of the NLPB website. These Standards of Pharmacy Operation reflect recent legislative changes and operational requirements that are necessary for expanded scopes of practice. Additionally, several existing Standards for community pharmacy have been incorporated so that all Board expectations for community pharmacy operation are contained in one document.

All pharmacists, pharmacy technicians and professional staff should review this document in detail as it deals not only with operations and policy issues but also a number of practice-related areas such as:

• the Professional Responsibilities of Pharmacists and Pharmacy Technicians
• more clarity on the requirements related to sending and receiving Transferred Prescriptions
• details on the requirement for a Final Check and Pharmacist-Patient Consultation prior to the release of a prescription

The Board thanks you in advance for your cooperation in meeting these Standards for community pharmacy. When all pharmacies meet the same minimum Standards, the public can be assured of the professions’ commitment to safe, quality patient care and consistent pharmacy service as well as readiness for expanded scopes of practice of pharmacists.

Changes to Process for Becoming a Pharmacist-in-Charge

NLPB would like to highlight changes to the application process for becoming a Pharmacist-in-Charge of a pharmacy.

This new application and authorization process was implemented in recognition that the position of pharmacist-in-charge is one of great professional responsibility. In this role, a pharmacist assumes full accountability for the operation of a pharmacy, including oversight of all activities carried out by both professional and non-professional staff.

The pharmacist-in-charge of a pharmacy is responsible to the Board for ensuring that the pharmacy is operated in accordance with federal and provincial legislation, NLPB Standards, and the Code of Ethics. To assess compliance with such, the Board conducts practice site assessments and evokes necessary practice change through working directly with the designated pharmacist-in-charge.

In order to become a pharmacist-in-charge of a pharmacy, an “Application for Authorization to be Designated Pharmacist-in-Charge” and a “Change in Pharmacy Licence” form must be submitted to NLPB 14 days in advance of the requested pharmacy licence change. The applicant will then be contacted to arrange a time to meet with the Registrar’s office to review the expectations for the position. A pharmacist-in-charge applicant should have practiced in this province for at least 12 months prior to the application and have suitable prior experience and be registered in good standing with NLPB.

If the Registrar’s office is satisfied that a pharmacist is able to fulfill the responsibilities of a pharmacist-in-charge, the application is approved and notification is sent to the applicant informing them that they are authorized to be pharmacist-in-charge of the given pharmacy. Authorizations are not in effect until applicants receive notification from NLPB. A new pharmacy licence with the name of the new pharmacist-in-charge will be issued and must be displayed in public view at the dispensary. New pharmacists-in-charge are requested to evaluate that the pharmacy operations are in-line with the Standards through completion of a pharmacy self-assessment form, a copy of which must be forwarded to NLPB.

Buprenorphine-naloxone Dispensing Requirements

In recent months, NLPB has received numerous questions and concerns from pharmacists and other healthcare providers regarding the dispensing of the buprenorphine and naloxone combination product (Suboxone® or generic equivalent). As per the drug product monograph for Suboxone®, buprenorphine-naloxone is approved for the treatment of opioid dependence in adults. The intention of the naloxone component is to deter intravenous misuse. Patients prescribed buprenorphine-naloxone should be carefully monitored within a framework of medical, social, and psychological support as part of a comprehensive opioid dependence treatment program.

PLEASE NOTE: While single entity buprenorphine (supplied as the transdermal patch Butrans®) is indicated for the treatment of pain, the combination therapy buprenorphine-naloxone has not been approved by Health Canada for pain management; therefore, prescribing of buprenorphine-naloxone for pain would be considered “off-label”. Faced with this situation, pharmacists are expected to rely on their knowledge, skills, patient assessment, and professional judgment to act in the best interest of the patient and determine the appropriateness of drug therapy. Supporting documentation for decision-making should be filed in a retrievable manner in the dispensary so that it is easily accessible when required for consultation with other health care providers, NLPB practice site assessments, and audits conducted by Health Canada.

In-line with its approved indication, pharmacists are expected to dispense buprenorphine-naloxone in accordance with NLPB Standards for the Safe and Effective Provision of Medication for the Treatment of Opioid Dependence, in particular:

• The pharmacist-in-charge must first apply to the NLPB to register the pharmacy as a site for opioid dependence treatment. Applications will be reviewed and, if approved, authorization will be issued.
• Pharmacists must apply to NLPB for authorization and provide proof of successful completion of an education program on the use of medication in the treatment of opioid dependence approved by the Board.
• Prior to dispensing, pharmacists must first confirm that the physician is eligible to prescribe buprenorphine-naloxone. Pharmacists can verify the physician’s eligibility by contacting the CPSNL at (709)726-8546.
• Pharmacists are expected to assess prescriptions for buprenorphine-naloxone for clinical appropriateness. If pharmacists see doses being prescribed outside of clinical guidelines for buprenorphine-naloxone therapy and NLPB and CPSNL Standards, they should consult with the prescribing physician and document their rationale for deviation in the patient’s record.
• Pharmacists are required to witness the ingestion of buprenorphine-naloxone. This function may not be delegated to a pharmacy technician, pharmacy student or any other member of the pharmacy team. Pharmacists are to directly observe the patient ingesting the dose.
• Buprenorphine-naloxone tablets can take 1-10 minutes for the tablet(s) to dissolve completely and pharmacists are expected to ensure that the entire dose has been dissolved and ingested.
• Administration of doses and provision of take-home doses must be appropriately documented on the patient’s Administration Log.
• Pharmacists are expected to assess that prescriptions for take-home doses are prescribed in accordance with the criteria and schedules outlined in the Standards. Rationale for deviations from such should be documented in the patient’s record.
• Take-home doses must be individually labelled, include all necessary cautionary labels, and be provided directly to the patient. Pharmacists cannot release take-home doses to an agent designated by the patient to pick up take-home doses on their behalf.
• Patients should be instructed to return their empty vials with original labels intact to the pharmacy for inspection and destruction and return of vials documented on the patient’s Administration Log.

To view the Standards in their entirety, visit the Standards, Guidelines and Policies page of the NLPB website. If there are questions or concerns related to the dispensing of buprenorphine-naloxone, please contact NLPB for guidance.

REMINDER – Pharmacists are Responsible for Maintaining Professional Liability Insurance Throughout the Year

It has come to the attention of the Board that some pharmacists may have inadvertently not renewed their professional liability insurance last year. Registrants are reminded that they have an obligation to ensure that they obtain and maintain professional liability insurance as set out in sections 14 and 18 of the Pharmacy Act, 2012 and section 8.(1)(a) of the Pharmacy Regulations, 2014 made under the Act. Please take this time to ensure you have professional liability insurance that meets the requirements as outlined by the Board in the document, Professional Liability Insurance Requirements for Registration, available on the Registration & Authorization Information For Registrants page of the NLPB website. During the 2016 annual renewal process, registrants will be required to record the insurance policy number in the online registration system.

First Year Residents Can Now Prescribe in NL

We have recently been notified by the Faculty of Medicine at Memorial University that recent changes to the Medical Act now allow first year medical residents to write and sign prescriptions. Residents are supervised by their preceptors in Family Medicine and other specialties. The residents have this ability through the College of Physicians and Surgeons (CPSNL) after completion of a mandatory Prescribing course in addition to passing the Medical Council of Canada Qualifying Examination Part 1.

The Faculty has committed to training family medicine residents well in this area and are promoting the use of Rx Files and Therapeutic Choices. They look to the vigilance and continued feedback from pharmacists when concerns are identified as they strive collaboratively to provide patients with the best possible care.

DEADLINE EXTENDED – Pharmacists Needed to Participate in Important Survey on Pharmacist Competencies for PEBC Examinations

The Pharmacy Examining Board of Canada (PEBC) is in the process of conducting a survey to evaluate the importance of each of the competencies required of pharmacists at the beginning of their professional practice. More survey participants are needed to reflect the practice of pharmacy in Newfoundland and Labrador. Registration to participate in the survey has been extended to August 26, 2015, with a survey completion date of September 13, 2015.

The competencies that form the basis of the test content outline for the PEBC Pharmacist Qualifying Examination were recently updated by the National Association of Pharmacy Regulatory Authorities (NAPRA). Data from the survey will be used to update the Qualifying Examinations for pharmacists to reflect the revised competencies and their importance in practice.

Registered pharmacists in active practice are needed to take the survey. If you are in active practice in a patient care setting, and are willing to participate in the survey as a representative of Newfoundland and Labrador, please take a few minutes now to register for the survey.

Please note that some institutions may block the linkage to survey monkey. If this occurs, we recommend that you use a home computer. If the link still does not work, please send your name, personal e-mail address and province/territory to PEBC@proexam.org.

It is critical that a large number of pharmacists from Newfoundland and Labrador participate in order to accurately reflect practice in our jurisdiction. We encourage you to help shape the future of the profession by being part of the study.

Pharmacists in active practice in a patient care setting are invited to register to participate at: https://www.surveymonkey.com/s/PEBC_Ph2015

Notice of Annual General Meeting of the Newfoundland and Labrador Pharmacy Board

The Annual General Meeting of the NLPB is scheduled to take place on Saturday, September 19, 9:00 a.m. – 9:45 a.m. at the Holiday Inn, 180 Portugal Cove Road, St. John’s

Annual General Meeting Agenda

1. Call to Order and Adoption of Agenda

2. Introduction of Board Members

3. Minute of Silence in Memoriam

4. Highlights of 2014 Annual Report

5. Questions on Annual Report

6. Appointment of Auditor for 2015

7. New Business

8. Announcement of Results of Election of Board Members

9. Installation of New Board Chair

10. Recognition of Service

11. Adjournment

The NLPB will also be delivering a Professional Development program on the upcoming Standards of Practice – Prescribing by Pharmacists at 10:00 a.m. immediately following the AGM.

REMINDER – Pharmacist-in-charge Requirements

Pharmacists-in-charge are reminded that, as per sections 11.(1)(d) and 12.(c) of the Pharmacy Regulations, 2014, the pharmacist-in-charge is required to practice at the pharmacy for at least one half of the operating hours of the pharmacy in order to meet their responsibility to oversee pharmacy operations. For pharmacies that have extended operating hours where half of the operating hours would exceed a typical full time schedule (more than 35-40 hours per week), it is expected that the pharmacist-in-charge would work a typical 35-40 hour work week at the pharmacy.

Through the NLPB Quality Assurance program, it has been identified that in a number of pharmacies, the pharmacist-in-charge is not practicing the required number of hours to oversee the operations of their designated pharmacy.

Issue 11 of The PostScript, published in July 2015, reviews the process for becoming (or changing) the designated pharmacist-in-charge of a pharmacy.

Expression of Interest – Pharmacy Technician Board Appointment

Under Section 5 of Pharmacy Act 2012, the Newfoundland and Labrador Pharmacy Board is seeking to appoint a Pharmacy Technician to serve as a Board member for a 24 month term commencing September 2015. Interested Pharmacy Technicians or Pharmacy Technician candidates who will be registered by September 11, 2015 are asked to forward a copy of their resume with a cover letter identifying your interest in serving on the Board to the NLPB office by September 11, 2015. All expressions of interest will be held in confidence. The incumbent will be announced at the end of the Annual General Meeting of the Board on September 19, 2015.

Transition Period for Opioid Dependence Treatment Standards Ending Soon

Pharmacists-in-Charge are reminded that the transition period given to pharmacies providing Opioid Dependence Treatment Services to align their practice and site with the new Standards for the Safe and Effective Provision of Medication for the Treatment of Opioid Dependence will soon come to a close. All pharmacies providing this service must be re-registered with the Board and all pharmacists working at the site must complete the education program and be appropriately authorized by the Board no later than November 30, 2015.

The Board staff are currently working on revisions to the Standards based on questions from pharmacists, feedback received during practice site assessments, and some recent product changes. It is expected that the revised document will be published to the Standards, Guidelines and Policies page of the NLPB website by the end of September.

Results of 2015 Board Elections

The process of electing Zone 1 and Zone 4 members to the Newfoundland and Labrador Pharmacy Board, for 3 year terms of office beginning at the Annual General Meeting of the Board on September 19, 2015 began with a call for nominations, which was emailed to all registered pharmacists in Zones 1 and 4 on June 21, 2015.

Nominations were received up until July 1, 2015, with three nominations received for Zone 1: Melissa Kielly, Karen Mercer and Jeremy Parsons; and one nomination received for Zone 4: Henry White.

Details of the election 2015, including instructions on how to vote with the online system, were emailed to registered pharmacists in Zones 1 on August 20, 2015, with the requirement to vote online no later than September 12, 2015. Viewing the results was conducted on September 14, 2015.

A total of 283 registered pharmacists were eligible to vote in zone 1. The total number of completed ballots returned was 52 (a return rate of 18%).

At the September 19, 2015 Annual General Meeting, the election results were announced with Jeremy Parsons elected in Zone 1 and Henry White elected by acclamation in Zone 4.

The following members comprise the NLPB Board for 2015-2016:

• Jeremy Parsons – Zone 1 Board Member – BioScript Pharmacy
• Ray Gulliver – Zone 2 Board Member – Baccalieu Pharmacy
• Dave Cramm – Zone 3 Board Member – Shoppers Drug Mart, Lewisporte
• Henry White – Zone 4 Board Member – Walmart, Stephenville
• Taggarty Norris – At Large Board Member – Lawton’s, Mount Pearl
• Chad Parsons – At Large Board Member – Shoppers Drug Mart, Goulds
• Jody Pomeroy – At Large Board Member – Central Health Pharmacy Department
• Carlo Marra – Dean – MUN School of Pharmacy
• Ruby Chaytor – Minister-Appointed – Public Representative
• Gerri Thompson – Minister-Appointed – Public Representative
• Donald Anthony – Board-Appointed – Public Representative
• Shirlene Murphy – Board-Appointed – Public Representative

Notice for Methadone Patients

On behalf of Eastern Health, please be advised that any MMT patients who have a previously scheduled appointment with Dr. Rizvi will now be seen by Dr. A. Abdulkhaliq. Their appointment will be at the same date and time but will now be at Dr. Abdulkhaliq’s clinic located at the Wellness Clinic, 48 Commonwealth Avenue, Mount Pearl, NL, A1N 5B6. If there are any questions or a patient needs to see the doctor before their scheduled appointment, patients can call 221-5666 and leave a message. The clinic will get back to them within 24 hours.

2016 Annual Renewals

Annual renewals for the 2016 registration year have begun. An email has been sent to all registrants and Pharmacists-in-Charge with instructions on how to renew.

New this year:

• Registrants are asked to provide the carrier name, policy number and expiry date for their professional liability insurance.
• Pharmacists in Charge are asked to provide pharmacy ownership information.




Registrants are advised to have this 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. Once completed, to print your receipt, please click View/Print Invoices and select the paid invoice as proof of payment.

Responsibilities of the Pharmacist-in-Charge

NLPB would like to highlight a few of the responsibilities of a Pharmacist-in-Charge as outlined in Section 12 of the Pharmacy Regulations, 2014. Pharmacists-in-Charge must be responsible for:

• actively directing, controlling or managing the pharmacy;
• prohibiting an owner or other person who is not a pharmacist from directing, influencing, controlling or participating in the management or operation of a pharmacy;
• developing, maintaining and enforcing written policies and procedures for pharmacy staff;
• ensuring that the pharmacy has the facilities, space, equipment, resources and systems in place to support the safe and effective provision of pharmacy services.




In-line with these defined responsibilities noted above, if a pharmacist-in-charge is unable to meet NLPB Standards due to employer interference or lack of cooperation, they have a duty to report this to the Board.

Standards of Pharmacy Operation

As previously communicated, new Standards of Pharmacy Operation-Community Pharmacy were approved by the Board in June. In this document there are four items that have been assigned a delayed implementation date of January 1, 2017, recognizing the time and resources that it may take for pharmacies to have these requirements in place. They are as follows:

• a private consultation area that provides visual and acoustic privacy;
• a connection to the provincial electronic health record through the Pharmacy Network;
• equipment to allow staff to scan documents and store them electronically;
• a refrigerator that meets cold chain requirements defined in Appendix II.




With the exception of these four items, the remainder of the Standards are currently in effect and subject to audit during quality assurance practice site assessments.

Pharmacies that participate in provision of medications for opioid dependence treatment must provide such services in a visually and acoustically private consultation area by November 30, 2015.

Standards for the Safe and Effective Provision of Medication for the Treatment of Opioid Dependence- Reminder of Upcoming Deadlines

Pharmacists who currently provide opioid dependence treatment must complete a mandatory education program – Optimizing Opioid Dependence Treatment and apply for authorization to participate in such services using the appropriate Form by November 30, 2015. All pharmacists who wish to participate in provision of opioid dependence treatment must complete this process prior to engaging in this practice.

Pharmacists-in-charge must also submit an Application to Register as a Pharmacy Participating in Opioid Dependence Treatment Services and receive approval from NLPB by November 30, 2015. Applications will not be approved until all pharmacists listed for the given pharmacy have received authorization and any necessary renovations are confirmed to have been completed.

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 Thursday, December 24th to Friday, January 1st, inclusive.

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

Narcotic and Controlled Drug Inspections by Health Canada

The Office of Controlled Substances from Health Canada is conducting narcotic and controlled drug audits in Newfoundland and Labrador. These audits aim to promote compliance to the Controlled Drugs and Substances Acts and its relevant regulations. The inspections will also verify the compliance of pharmacists to the applicable regulations such as purchase records, prescription records, loss and theft reports, inventory reconciliation and security measures.

Health Canada intends to conduct approximately 1000 inspections across the country from 2015 to 2019. The selection of community pharmacies to be inspected will be random but representative of the distribution of pharmacies across Canada. Health Canada has prepared a DRAFT FAQ on this initiative which can be found by clicking HERE.

Application to Register as a Pharmacy Participating in Opioid Dependence Treatment Services

Pharmacists-in-charge are reminded that both pharmacists and pharmacies (including hospital pharmacies) must be authorized by NLPB to participate in opioid dependence treatment (ODT) services. Pharmacies that have offered ODT services since before the new Standards came into effect must also complete a new application to declare that new Operational Standards are met. The transition date for this process to be completed was November 30, 2015. This requirement is outlined in section 4 of the Standards for the Safe and Effective Provision of Medication for the Treatment of Opioid Dependence as follows:

• Before permitting medications for opioid dependence to be dispensed at the pharmacy under their supervision, the pharmacist-in-charge must first apply to the Newfoundland and Labrador Pharmacy Board to register the pharmacy as a site for opioid dependence treatment.
• Applications will be reviewed and, if approved, authorization will be issued to the pharmacist-in-charge. Once authorized, the pharmacist-in-charge must ensure that the pharmacy meets certain minimum operational standards on an on-going basis.

To date, 237 pharmacists are authorized and 43 practice sites are registered to participate in ODT services.

The Application to Register as a Pharmacy Participating in Opioid Dependence Treatment Services can be found on the Licensing Information for Pharmacies page.

Medication Management Authorizations Will Expire on December 31, 2015

All pharmacists are reminded that any current authorizations for pharmacists to participate in Medication Management services (providing an interim supply, extending a prescription and adapting a prescription) under the former Medication Management Standards of Practice will remain in effect only until December 31, 2015, after which time pharmacists must be authorized to prescribe under the new Prescribing Standard of Practice in order to continue participating in these services.

Only pharmacists authorized by the Board, as outlined in the Standards of Practice – Prescribing by Pharmacists (available on the Standards, Guidelines and Policies page) are authorized to prescribe. Pharmacists who wish to be authorized to prescribe must complete a mandatory Orientation Program and then apply to the Board by submitting a completed Application for Authorization to Prescribe (found on the Registration and Authorization page) with the supporting documentation and associated fee. Pharmacists will be notified by email once the application has been reviewed and approved.

To date, 280 pharmacists have been authorized by NLPB to prescribe.

Safety Concerns Regarding the Storage of Medications in Certain BD Syringes

Potential concerns relating to the storage of drugs in certain sterile plastic disposable syringes were brought to light in recent advisory communications by the Food and Drugs Administration (FDA), Becton-Dickinson (BD) and Health Canada, as referenced in the documents below:

• FDA Safety Alert – Compounded or Repackaged Drugs Stored in Becton-Dickinson (BD) 3 mL and 5 mL Syringes: FDA Alert – Do Not Use Unless There Is No Suitable Alternative
• BD Syringe Notification Letter
• Health Canada Advisory – Becton-Dickinson – Disposable Syringes and Reduced Drug Potency Issues
• ISMP Comments On BD Syringe Potency Issue

The following recommendations are intended to provide guidance to mitigate potential risk and enhance patient safety while ensuring continuity of care:

1. Raise awareness of this issue and its potential impact on patient safety with senior executives including those in other areas of the facility (i.e. operating rooms) where healthcare professionals, other than pharmacists and pharmacy technicians, may be preparing and storing medications in syringes.
Note: Practitioners are reminded that beyond use dates (BUD) in United States Pharmacopeia chapter 797 as well as in the Canadian Society of Hospital Pharmacists’ Compounding: Guidelines for Pharmacies address the sterility of a compounded preparation made using aseptic technique under specified conditions—not the potency or other tests of drug stability. As such, simply shortening the BUD may not be sufficient.

2. Conduct a review and risk assessment for drugs that are currently being stored in syringes. If there are high-risk agents identified where any loss of concentration could be clinically significant (e.g. antibiotics, chemotherapy, anticonvulsants), prepare medications as close to the administration time as possible.

3. Evaluate what drugs may be packaged in alternate formats, e.g. minibags.

4. Purchase commercially available products approved for use in Canada.

5. If prepared drugs are to be stored in syringes do not use syringes from the affected lots of BD syringes. Check the BD website to identify the affected lots; ensure that ALL affected lots are removed from circulation within the pharmacy and anywhere medications may be prepared and stored in syringes.