Please click the link below to bring you to the appropriate section:
- General Pharmacy Practice Questions
- Questions about Compounding
- Questions about Pharmacy Technician Practice
- Questions about Pharmacy Intern Practice
- Questions about Narcotics and Controlled Drugs
- Questions about Prescribing by Pharmacists
- Questions about Administering Drugs by Inhalation or Injection
General Pharmacy Practice Questions
- Who may prescribe in Newfoundland and Labrador (NL)?
The Pharmacy Act, 2012 defines a prescription to be “an instruction, directing that a drug be dispensed to or for a person or animal, given orally, in writing or by an electronic means approved by the board by a person authorized to do so by an Act of the province or by a prescriber referred to in section 26;”
At this time, in NL, physicians, dentists, veterinarians, nurse practitioners optometrists, and pharmacists all have varying authority to prescribe. To verify the current status of a prescriber in NL, you can check the relevant list linked on our Find a Health Professional page.
- Can I legally fill a prescription written by a prescriber licensed in another province of Canada?
Generally speaking, the answer to this question is usually “yes.” In accordance with section 26 of the Pharmacy Act prescriptions written by prescribers licensed and practicing in another province are eligible to be filled in this province.
Having said that, there are a few conditions to consider. First, it depends on the type of prescriber and whether or not that person would have prescribing authority if they were licensed in Newfoundland and Labrador (NL). At this time, in NL, physicians, dentists, veterinarians, nurse practitioners, and optometrists all have varying authority to prescribe. An out-of-province prescriber would have to belong to one of these groups for their prescription to be valid in this province. For example, a prescription from a dentist would be valid; a prescription from a chiropractor would not.
Second to this would be what the prescription is for. 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.
Pharmacists are also reminded that the onus is on them to verify the authenticity of any and all prescriptions and if he or she is ever in doubt as to the validity of the prescription or the licensing status of the prescriber, he or she should follow up with the prescriber directly and/or contact the relevant licensing authority.
- Are electronic prescriptions acceptable?
More and more prescribers are utilizing technology to manage their patient files, access information, and generate prescriptions. As with all prescriptions, pharmacists and pharmacy technicians must be able to ensure the authenticity of prescriptions that have been generated electronically and also be confident that the document presented to them has not been replicated or altered.
As such, the following are considered to be acceptable:
- Prescriptions generated electronically by a prescriber’s password-protected electronic medical record (EMR) and faxed directly to a pharmacy.
- Prescriptions generated electronically, printed, and faxed DIRECTLY to a pharmacy from the prescriber’s/clinic’s fax machine, in accordance with the
NLPB Standards of Practice- Facsimilie Transmission of Prescriptions and Personal Health Information.
- Prescriptions generated electronically, printed, hand-signed by the prescriber, and given to the patient to bring to their pharmacy.
The following would NOT be acceptable:
- Prescriptions generated electronically, with pre-printed signature images that are given to the patient to bring to their pharmacy, without being hand-signed or initialed by the prescriber.
- Prescriptions sent via email.
- Prescriptions for drugs referenced in section 4.(1) of the Pharmaceutical Services Regulations – i.e. the “Drugs Required to be Written on Tamper Resistant Pads”.
- How should I handle new prescriptions or requests for refills when a prescriber passes away, retires, or otherwise ceases practice?
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, assuming the prescription is not more than a year old, it would still be considered a legal prescription. Another question to consider in these instances is whether filling or re-filling the prescription is appropriate – which needs to be assessed on a case-by-case basis.
NLPB 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 re-filling the medication? (Or conversely, is the patient at an increased risk of harm if the medication is not provided in accordance with the original prescription?)
- 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.
Questions about Compounding
- What is the relationship between the compounding supervisor and pharmacist-in-charge?
The pharmacist-in-charge (PIC) is responsible for developing, organizing, and supervising all activities related to pharmacy compounding. The PIC may share or assign these responsibilities to a pharmacist or pharmacy technician, who will be designated as a “compounding supervisor.” Otherwise, the PIC is the compounding supervisor by default.
A compounding supervisor is a pharmacist or pharmacy technician designated to supervise activities related to the compounding of specific preparations. This role may be carried out by the PIC or the PIC may delegate this role to another appropriate staff member. This person works with the PIC, pharmacy management, and compounding personnel. A compounding supervisor develops, organizes, and oversees all activities related to the given area of compounding.
If the PIC designates a pharmacist or pharmacy technician as the compounding supervisor and this person does not carry out their responsibilities for any reason, the PIC must assume the responsibilities of the compounding supervisor. In addition, the PIC must ensure the compounding supervisor adequately fulfills their role as the PIC is ultimately responsible for the operation of the pharmacy. For these reasons, the PIC must be qualified to perform and oversee the different types of compounding activities of the pharmacy.
- Can a pharmacist or pharmacy technician be a compounding supervisor at more than one site?
The intention is that there is a person designated as compounding supervisor per site to develop, organize, and supervise all activities related to pharmacy compounding of sterile products. This may be the PIC or a shared responsibility with an individual who has been delegated this role. This does not necessarily mean that “compounding supervisor” must be a person’s sole responsibility, or that a person cannot be compounding supervisor at more than one site. However, the acceptability of having an individual responsible for more than one site would depend on the scope of compounding services at the site and whether the compounding supervisor can fully meet the responsibilities outlined in section 22.214.171.124 of the standards at each site.
- Can a pharmacy have more than one compounding supervisor (i.e. can multiple staff share this role)?
If the scope of compounding activities requires more than one qualified individual to meet the responsibilities of a compounding supervisor, the pharmacist-in-charge may designate more than one individual to this role. However, the individuals must be specifically designated as compounding supervisors (i.e. it cannot be “pharmacist/pharmacy technician on duty”) and there must be a clear delineation of compounding supervisor duties to ensure all responsibilities are fully met.
Each type of compounding practice (sterile hazardous/non-hazardous, non-sterile non-hazardous/hazardous) may have a different compounding supervisor as well.
- Does NLPB approve facility design?
Pharmacists-in-charge (PICs) are required to submit an Application for Renovation of an Existing Pharmacy/Dispensary to NLPB at least 15 days in advance of planned renovations, and receive approval of the application, before starting the renovation. It is recommended to submit renovation applications at the earliest opportunity, especially for complex facility designs, so that NLPB staff can review, ask questions, and provide feedback.
With that said, NLPB does not approve the design of compounding facilities. The design and construction of compounding facilities requires specific engineering expertise to ensure the necessary ventilation, airflow, and pressure differential, and certain equipment (such as containment primary engineers controls [C-PECs]) require maintenance and certification by qualified individuals. It is important that pharmacy personnel collaborate with engineers and contractors in the design of their compounding space. While the design of a space requires expertise beyond that of a pharmacist, input from pharmacy personnel is still important so that workflow and efficiency are taken into account.
PIC and compounding supervisors are responsible for ensuring that their compounding space is appropriately designed in accordance with the applicable standards and they must be able to demonstrate this is the case to NLPB assessors.
- What is the difference between the standards and the guidance document? Do I have to follow everything in the guidance document?
The standards are the minimum requirements for all registrants involved in non-sterile compounding. It is mandatory that pharmacies involved in non-sterile compounding be compliant with the standards. The guidance document was developed by NAPRA as a resource, if needed, to provide more detail and direction on implementing the standards. Registrants may choose to meet the required standard using another process than one suggested in the guidance document; this is acceptable as long as the process meets or exceeds the requirements in the standard. The pharmacy must have documentation to support the rationale for alternate approaches.
- If we find that our non-regulated pharmacy team members need more training, where can we access this?
Some pharmacists and pharmacy technicians have already participated in in-house training and have proactively performed reviews of the compounding techniques of non-regulated pharmacy staff members. Registrants are cautioned to only use this method of remediation if they are current in their knowledge and experience base. Some companies supplying compounding ingredients offer training opportunities for pharmacists and pharmacy technicians who are new to compounding, or to those seeking to improve their skills. Pharmacists-in-charge and compounding supervisors are encouraged to research those options and, if appropriate, have at least one staff member take the training, and train and assess others at the practice site.
- How do I decide what I should and should not be compounding?
Consider the following questions:
- Are the active ingredients already available in a manufactured product?
- Is there a manufactured product that would have a similar therapeutic benefit?
- Do you have a referenced formulation, with stability data and a beyond-use-date? If not, do you have the general knowledge to assess the compatibility of ingredients, determine how to compound the product, assign a beyond-use-date, etc.?
- Do you have an appropriate space to compound the given preparation?
- Do you have the necessary equipment and ingredients to make the compounded preparation?
- Have you completed a risk assessment of the preparation?
- Can you mitigate any identified potential health hazards to compounding personnel?
- Would the patient be better served at another pharmacy that has appropriate facilities, equipment, and expertise?
Risk assessment is an important part of this decision. Refer to section 4 of the standards and guidance document for the expectations and guidance on risk assessments. The guidance document provides an algorithm to assist with the risk assessment process as well as a list of factors to consider that help with putting information into context.
The decision to not compound should not be taken lightly. It is also important to consider the NLPB Code of Ethics. Pharmacy professionals are expected to hold the health and well-being of their patients as their primary consideration and do what they can to meet patients’ health needs. The default should be to aim to provide services to the extent that is possible, and when it is not possible to compound a specific product, refer the patient to a colleague who can. Pharmacy professionals need to be able to explain to patients why they can or cannot provide a compounded preparation.
- Can you provide examples or a list of Level A, B, and C Compounding?
As a self-regulated health professional, you are expected to use your knowledge, skills, and judgment to perform a risk assessment of each preparation compounded in your pharmacy. Consider all the factors outlined in the standards and guidelines, utilize all necessary resources and references, then assign the risk level, and document your decision with rationale in the master formulation record.
Examples of how a risk assessment may be conducted have been provided by other regulatory bodies in Canada (available on Pharmacy Practice Resources page of nlpb.ca); however, the individual factors in your practice setting may result in a different risk assessment for the same formulation than these examples or another practice site. If there is uncertainty regarding the risk level to assign, the compounding supervisor, in collaboration with the manager, may choose to adhere to the standard for the higher risk level in the interest of safety.
- The decision algorithm for risk assessment (Diagram 1 in the guidance document) references both the “NIOSH list of dangerous drugs” and “health hazard(s) under the Hazardous Products Act.” What is the difference between the two?
In Canada, legislation (the Hazardous Products Act and related Regulations) requires that hazardous products used in the workplace are labelled to identify the associated hazards. Schedule 2 under the Hazardous Products Act provides a listing of health hazard classes.
The Government of Canada, Canadian Centre for Occupational Health and Safety defines the WHMIS (Workplace Hazardous Materials Information System) as a “comprehensive plan for providing information on the safe use of hazardous materials used in Canadian workplaces. Information is provided by means of product labels, material safety data sheets (MSDS) and worker education programs.” Pharmacy professionals can assess whether an active pharmaceutical ingredient (API) is a health hazard under the Hazardous Products Act by referring to the API label and the SDS sheet for the API.
The NIOSH list is an American reference from the U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health (NIOSH), and includes ingredients more specific to health care materials: NIOSH List of Antineoplastic and Other Hazardous Drugs in Health care Settings 2016.
Both the NIOSH list and WHIMIS should be considered as part of a risk assessment, as each provides information regarding potential health hazards associated with compounding ingredients.
It is important to note an SDS may indicate that an API represents a health hazard even if the drug is not included on the NIOSH list of hazardous drugs.
- How do I determine if a product is listed as a health hazard under the Hazardous Products Act? How do I use the product safety data sheet (SDS) to determine the hazards identified with that product?
Pharmacy professionals are expected to refer to Safety Data Sheets (SDSs) for active pharmaceutical ingredients (APIs) to determine any associated health hazard classes. SDS sheets should be accessible from the manufacturer of the API – therefore, a pharmacy professional should be able to access an SDS directly from the manufacturer or from the distributer the API was purchased from. On each SDS, refer to Section 2 for the Hazards Identification. In addition, refer to Section 8 of an SDS for information regarding the recommended exposure limits, engineering controls, and personnel protective equipment.
This fact sheet on Safety Data Sheets may be helpful.
Compounding supervisors must ensure that SDS sheets for APIs are used to conduct risk assessments of compounds, and that risk assessments for compounded preparations are available to all staff involved in compounding to make sure that they are aware of all possible risks.
- What should I do if I am uncertain about the risk level of a compound?
If, after conducting a risk assessment to the best of your ability, you are still uncertain as to the level of risk, then registrants should always defer to the higher standard.
- What is a small quantity?
A “small quantity” depends on the risk assessment for each API which should include an assessment of the frequency of compounding with these ingredients. As per section 4.1 of the guidance document, some factors to consider in the risk assessment include the:
- complexity of compounding the preparation;
- need for verification and uninterrupted workflow;
- frequency of compounding high-risk or low-risk preparations;
- risk of cross-contamination with other products (e.g., allergens);
- concentration of ingredients in the product;
- quantity of ingredients being handled;
- physical characteristics of ingredients (e.g., liquid vs. solid vs. powders, or water-soluble vs. lipid-soluble);
- education and competency of compounding personnel;
- availability of appropriate facilities and equipment;
- classification of ingredients if identified by WHMIS as presenting a health hazard, or a drug classified by NIOSH as hazardous (see reference to NIOSH in section 4.3 of the guidance document);
- type of hazardous drug (e.g., anti-neoplastic, non-antineoplastic, reproductive risk only);
- exposure to compounding personnel for each preparation and accumulation of exposure over time; and,
- risk of microbial contamination (liquids, creams, and ointments may be particularly susceptible to microbial and other contamination).
The risk assessment must be reviewed on a continuum to identify and mitigate risk thereby providing quality assurance. A decision algorithm to assist in determining requirements for non-sterile compounding can be found in section 4.2 of the guidance document.
Note: Occasional small quantities of materials must not be considered in isolation. If several different high-risk or low-risk preparations are being compounded, the cumulative risk must be considered even if they are compounded on different days. This must be documented in the risk assessment.
- Can I continue to compound preparations that are assessed to be a higher level than my facility (for example, a Level B or C compound in a Level A space) until the final implementation deadline?
That depends – can you safely make a high-quality compound? The high-level principle is that once you know better, the expectation is that you do better. If through the risk assessment process you determine that an ingredient in a compound poses a health risk to pharmacy staff, then you need to be able to mitigate that risk in order to continue compounding. Similarly, if you determine that you do not have the necessary information, equipment, or supplies to properly compound a given preparation, then the expectation is that you refer the patient to a pharmacy that has the capability to make a high-quality product. It is never okay to knowingly put patients or pharmacy personnel at risk.
Section 4 of the guidance document also addresses this question as follows:
If it is necessary to compound a preparation requiring procedures or processes that are not currently in place within the pharmacy, the documentation should specify the potential risks of compounding the product, the extra steps that must be taken to mitigate the risks, and references confirming that these steps actually will minimize risks to the quality of the product and safety of personnel. The following examples illustrate these concepts:
- For a complex compound, the documentation should specify extra measures required, such as measures to ensure uninterrupted workflow, extra verification steps, extra equipment, and supporting references.
- If a small quantity of a hazardous product is used in compounding, there must be documentation of alternative containment strategies and/or work practices being employed for specific dosage forms to minimize occupational exposure.
- Do you need separate areas for compounding hazardous and non-hazardous non-sterile preparations?
It is preferable to have separate areas for performing hazardous and non-hazardous non-sterile compounding. If the same area is being used for hazardous and non-hazardous non-sterile compounding, compounding personnel must ensure proper deactivation and decontamination processes are in place to prevent cross-contamination. This includes having dedicated equipment to perform compounding activities in a separate room. Disposable or clean equipment for compounding (such as mortars and pestles, spatulas) must be dedicated for use with hazardous drugs. Additionally, if hazardous materials are used in the same space during compounding as non-hazardous materials, then non-hazardous compounded preparations must be packaged to identify that they may have been exposed to hazardous materials.
- My pharmacy will be making Level A compounds only; do I need to renovate my pharmacy?
There are specific physical requirements that must be met in order to perform any level of compounding; therefore, depending on the current state of the pharmacy, renovations or modifications may be necessary. These include:
- A designated compounding area that has enough space to store equipment and supplies and for compounding personnel to work comfortably and safely. This area should be located in a space of reduced traffic to prevent contamination of the product and where there is minimal distraction to employees.
- A source of hot and cold running water must be contained within or close to the compounding area.
- The compounding area must have sufficient lighting.
- The compounding area must be designed to facilitate repeated cleaning. Work surfaces, furniture, walls, and flooring should be made of smooth, impenetrable, and non-porous material. Consider the need to change the surface you compound on, replacement of a section of flooring or appropriate flooring cover, etc.
The scope of compounding activities that pharmacies need to carry out to support their patients will vary from pharmacy to pharmacy. As such, pharmacy professionals need to apply the principles in the standard to their own practice site.
- For Level A compounding, does a “designated compounding area” mean a separate room?
No, a separate room is not required.
While “separate” and “designated for the preparation of compounds” ideally means the space is only used for that purpose, NLPB recognizes the challenges that would create for some pharmacies. If the compounding area needs to be used for other functions, it must be maintained such that it can be cleaned quickly and made appropriate for safe compounding when needed. However, other activities cannot be performed in this area while compounding is occurring.
- What is the minimum size for a designated Level A compounding area?
There is no minimum size requirement.
The compounding area must be large enough for compounding personnel to work comfortably and safely, with room to store equipment and products in an orderly manner in clean and secure surroundings. Also, the area should be designed and arranged to prevent cross-contamination between products, and it should be located away from parts of the pharmacy where there is a considerable amount of traffic (e.g., aisles, entrance, exits).
- What is Level B compounding?
Level B compounding includes:
- Complex, non-hazardous compounding; AND/OR,
- Occasional compounding with potentially hazardous or irritating ingredients.
As per the USP 795 definition that is included in the guidance document, complex compounding means making a preparation that requires special training, environment, facilities, equipment, and procedure to ensure appropriate therapeutic outcomes. Examples of possible complex preparation types include transdermal [delivery system] dosage forms, modified-release preparations, and some inserts and suppositories for systemic effects.
- What are the physical requirements for Level B compounding?
Section 8.2 of the Non-Sterile Compounding Standards states that, in addition to the Level A requirements, Level B compounding requires:
- A separate well-ventilated room (always); and,
- A ventilated containment device, if compounding with certain powders, aromatic products, or hazardous products that pose risk to the compounder.
Examples of the latter include allergenic products or products that could have unintended effects, such as hormones, but that may not require the extensive precautions of Level C requirements if prepared in small quantities and risk can be mitigated (see section 4.2 of the guidance document for risk assessment). If a ventilated containment device is used, the pharmacy should follow the same requirements as outlined in section 9.2.3 of the Non-Sterile Compounding Standards.
- My colleague told me that pharmacies that meet Level A requirements cannot compound with any powders or ingredients that are designated as health hazards – is that correct?
Not necessarily. As per the guidance document, many non-sterile preparations can be compounded within a Level A space. These preparations could include simple and moderate compounds that contain hazardous drugs in NIOSH Group 2 or 3, or materials designated as health hazards by the Hazardous Products Act but are deemed to pose little or no risk for compounding personnel when compounded in occasional small quantities (i.e. quantities determined to represent low risk to compounders in a particular instance at the pharmacy if appropriate precautions are taken).
It is important to remember that not all Level A spaces are the same. The scope of activities that may be performed in a specific pharmacy depends on the unique characteristics of that site. The pharmacist-in-charge and compounding supervisor of each pharmacy must carry out a site-specific assessment of what compounding activities are appropriate and these may differ from other Level A pharmacies.
- What are the differences between the Level B and C facility requirements?
The facility requirements for Level A, B, and C build upon each other in accordance with risk to both patients and compounders.
Level C requires a separate, well-ventilated room with:
- Appropriate air exchange (at least 12 air changes per hour [ACPH];
- Negative pressure (-2.5 Pa relative to surrounding areas);
- A ventilated containment device (i.e. containment primary engineering control [CPEC]); and,
- PPE appropriate for handling hazardous products.
Section 9 of the Non-Sterile Compounding Standards and guidance document provides additional specific details on facility requirements for hazardous preparations. The notable differences from Level B are the specific air exchange and pressure requirements, the requirement for a C-PEC, and external ventilation. A Level B room is not required to be under negative pressure, and it may or may not have a C-PEC based on the risk of the APIs used for compounding and the amount/frequency they are used.
Level C facility requirements must be met when compounding any amount and any dosage form of hazardous drugs that are classified by NIOSH as Group 1 or hazardous materials that are classified by WHMIS to present health hazards such as very irritating to the respiratory tract, skin or mucous membranes. Level C facility requirements also apply to NIOSH Group 2 and 3 drugs involving routine use of large quantities of APIs, according to the risk assessment.
- How do I determine whether external ventilation is needed for non-sterile compounding?
Pharmacists-in-charge and compounding supervisors must determine whether external ventilation is required for both the compounding room, as well as for the containment primary engineering control (C-PEC) through their risk assessment. All risk assessments must be made available to staff involved in compounding.
- External ventilation is not required for a Level A designated and separate compounding area.
- External ventilation is not required for a Level B separate compounding room; however, this room must be “well-ventilated.”
- External ventilation through high-efficiency particulate air (HEPA) filtration is required for a room used for compounding hazardous preparations needing Level C requirements. When in doubt, defer to the higher standard (Level C).
Examples of C-PECs used in a Level B or C compounding room include containment ventilated enclosures, Class I or Class II Biological Safety Cabinets, compounding aseptic containment isolators (CACIs), etc. If the C-PEC is being used to handle hazardous products, it should be externally vented (preferred option) or have redundant HEPA filters in a series.
Questions about Pharmacy Technician Practice
- What is the scope of practice for a registered pharmacy technician?
In the Spring 2017 edition of the NLPB newsletter, The Apothecary, the following table was published (to enlarge, right click on image and select “open image in new window”):
For more information, please view the NAPRA Professional Competencies for Canadian Pharmacy Technicians at Entry to Practice and the Model Standards of Practice for Canadian Pharmacy Technicians. These are really the “gold standard” for technician practice in Canada.
- What is a pharmacist’s responsibility when collaborating with a pharmacy technician to dispense a prescription? Does this responsibility change for refills?
Regardless of whether the patient has presented a prescription for a new medication, a new prescription for ongoing therapy, or has requested a refill, no medication can be released to the patient without a pharmacist reviewing the patient’s medication profile, assessing the therapeutic/clinical appropriateness of the drug therapy, and providing patient counselling, as required.
Pharmacists and pharmacy technicians cannot assume that a clinical check performed for the first fill of a prescription fulfills the required clinical check by a pharmacist for subsequent refills (including those in compliance packages). A patient’s circumstances and health can change between the time of the first prescription and subsequent refills – especially if the medication is prescribed long-term. Over time, patients age, may lose or gain weight, receive new diagnoses, have changes to their medications, become pregnant, or experience other health-related changes that could impact the continued suitability of a prescribed medication. As such, there is an expectation for on-going clinical review of the medication profile by the pharmacist.
Pharmacy technicians can assess the currency, authenticity, and completeness of prescriptions as well as be accountable and responsible for the technical aspects of prescriptions such as ensuring the right:
- Drug, Dosage Form, Route, Dose and Quantity
However, pharmacists remain responsible for ensuring:
- the prescription is appropriate / still appropriate for the condition being treated
- the dosage is safe and appropriate / still safe and appropriate for the patient based on patient-specific factors such as age, weight, organ function, pregnancy or lactation status, etc.
- the medication is compatible / still compatible with current medical conditions and allergies
- the medication is compatible / still compatible with other medications being taken
The responsibilities noted above are outlined in section 3.1 of the Standards of Pharmacy Operation – Community Pharmacy, and section 3.3 of the Standards of Pharmacy Operation – Hospital Pharmacy. In addition, sections 1.11-1.14 of the Standards of Practice for Canadian Pharmacists, state:
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.
Additionally, in accordance with section 3.8 of the Standards of Pharmacy Operation – Community Pharmacy, pharmacists are also expected to assess the need for patient counselling for refills by asking questions regarding changes to dosage regimens, compliance, efficacy, and the presence of adverse effects and then counsel accordingly, if necessary.
And finally, in accordance with section 3.5 of the Standards of Pharmacy Operation – Community Pharmacy, each dispensing record must also contain documentation of:
- i) any interactions that were detected, how they were addressed, and who addressed them;
- ii) the identity of all staff members involved in the dispensing and checking processes; and
- iii) the name of the pharmacist who delivered patient counselling and the date and time the counselling was given.
Questions about Pharmacy Intern Practice
- Do I need a preceptor during an extended registration as an intern?
No, once the NLPB Pharmacist Internship is completed, you do not need a specified preceptor, but you will need to be working under the supervision of a pharmacist at all times.
When you apply to extend your registration as an intern, a pharmacist who has agreed to be responsible for your supervision will also need to sign this form to indicate to NLPB that they have accepted and understand this responsibility. You do not necessarily need to practice with this pharmacist at all times–the supervising pharmacist may delegate another pharmacist to supervise and support you while they are not there.
Accountability for a pharmacy intern’s practice is shared between them and the supervising pharmacist.
- The supervising pharmacist is accountable/responsible for ensuring that the appropriate level of supervision is provided to an intern, based on ongoing assessment of the individual intern’s competence. It is important that the supervising pharmacist understands they are ultimately accountable/responsible for an intern’s practice regardless of the level of independence granted-there must be appropriate oversight, checks, and balances in place at all times.
- As a pharmacy intern, you are accountable/responsible for your own practice and should only engage in an activity when competent to do so. It is an intern’s responsibility to seek assistance from the supervising pharmacist, as needed.
- What can I do as an intern – what is my scope?
As per the Act, a pharmacy intern may perform most duties within the scope of practice of a pharmacist, as long as they are under the supervision of a pharmacist.
The requirement for “supervision” in this case is more open-ended than the requirement for “direct supervision” of pharmacy students. Supervision is not a one-size-fits-all approach and calls for the active engagement of all participants to ensure a quality learning environment while maintaining the best possible patient care.
When determining the appropriate level of supervision required, the supervising pharmacist must assess the intern individually by considering the intern’s level of education and experience, and evaluating the intern’s competence in relevant areas of practice.
Once the supervising pharmacist is comfortable with allowing some independence, they and the pharmacy intern should come to a shared understanding of the types of activities that can be performed independently and the extent to which these activities can be performed without the direct observation of the supervising pharmacist.
When providing indirect supervision, the supervising pharmacist must be readily available for consultation and, if necessary, for providing hands-on assistance to the intern and ensure the intern complies with established standards, policies, and procedures.
The scope of activities an intern is comfortable with and the level of independence required when carrying out pharmacist duties may vary from intern to intern. It will depend on previous practice experiences and the amount of time practicing with the supervising pharmacist and their team.
- Are there specific things I am not permitted to do?
Certain NLPB Standards of Practice require authorization from NLPB in order for pharmacists to be able to participate in that practice. These practices include the following:
- administering an inhalation or injection
- participating in Opioid Agonist Maintenance Treatment (OAMT)
Authorizations for these practice areas are only available to pharmacists. As such, interns cannot be authorized until they are registered as pharmacists and meet the established criteria. An intern cannot independently perform these activities under any circumstance; however, interns can assist pharmacists who have a given practice authorization with services if they have the appropriate training and under direct supervision. Pharmacy interns are encouraged to complete the necessary education, training, and orientation programs associated with these specific practice areas so they can get the most of their learning experience.
With regards to administering injections in accordance with the NLPB Practice Policy-Pharmacy Students/Interns Administering Inhalations or Injections, a pharmacy intern may administer drug therapy by inhalation or injection under the following conditions. The pharmacy intern must:
- be registered with the NLPB (including maintaining appropriate professional liability insurance);
- have successfully completed 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.
- I completed my injection training during pharmacy school. By the time I am able to submit an application for authorization, it will be more than one year since I completed my training–will I be required to take a refresher course?
The Standards for the Safe and Effective Administration of Drug Therapy by Inhalation or Injection require applications for authorization to administer injections to be submitted within one year of successful completion of the required education program.
NLPB will make an exception to this requirement for those who have extended their registration as an intern, providing that they:
- apply for injection authorization at the earliest opportunity;
- demonstrate continued injection competence by submitting an injection log that indicates they have properly administered injections under the supervision of an authorized pharmacist while practicing as an intern and in the timeframe leading up to the application date; and,
- meet all other injection authorization requirements, including proof of 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).
- Can an intern be independently accountable for the clinical verification or final product check of a prescription?
As per the Act, a pharmacy intern may perform most duties within the scope of practice of a pharmacist as long as they are under the supervision of a pharmacist. Regardless of the level of independence deemed appropriate by the supervising pharmacist and the intern–the supervising pharmacist still holds a level of accountability for the role the intern plays in the dispensing of each prescription.
Section 3.1 a) of the Standards of Pharmacy Operation (SOPO) identifies the professional responsibilities of a pharmacist as follows:
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:
- i) appropriateness of drug therapy;
- ii) drug interactions;
- iii) allergies, intolerances or adverse drug reactions;
- iv) therapeutic duplication;
- v) correct dosage, route, frequency and duration of administration and dosage form;
- vi) contraindicated drugs;
- vii) patient adherence issues; and
- viii) any other potential drug-related problems.
Pharmacists will have to determine whether or not they feel they have met their professional responsibilities if they delegate certain duties to an intern and will need to be prepared to take accountability for that decision. On the other hand, it is an intern’s responsibility to self-govern and only agree to perform duties that are within their competence. This decision will be at the discretion of both parties and will likely depend on the intern’s experience and professional relationship with the pharmacist.
The SOPO also requires documentation identifying the pharmacy team members involved in each stage of the dispensing process. The pharmacist-in-charge and the supervising pharmacist (if different) will need to consider how interns will be integrated into dispensing processes and how to document the intern and supervising pharmacist’s involvement in each prescription. This could potentially involve changes to pharmacy workflow, the development of new documentation processes, and/or practice management system software changes.
Other factors that should be considered when assessing how to integrate an intern into the dispensing process include:
- the need for a pharmacist to be associated with the medication dispense in the electronic health record
- the acceptability of a pharmacy intern “sign off” to third party payers
- any limitations to the intern’s liability insurance coverage (in terms of practicing independently)
Pharmacists-in-charge, supervising pharmacists, and interns will need to do an assessment of the above and determine what they are collectively comfortable with.
Questions About Narcotics and Controlled Drugs
- Can I legally fill a prescription for a narcotic or controlled drug if it was written by a prescriber licensed in another province of Canada?
If the drug is included on the Schedule of Drugs for the Tamper Resistant Prescription Drug Pad (TRPP) Program, then the answer to this question will usually be “no”, since all prescriptions for these drugs MUST be written on the approved tamper-resistant pad, and these pads are rarely given to prescribers from outside the province. For more information on this program, visit the Department of Health and Community Services website.
If the drug is not included on the Schedule of Drugs for the TRPP Program, or if the prescriber has been issued the approved pad, then the answer would be “yes” so long as that person would have prescribing authority if they were licensed in Newfoundland and Labrador (NL). At this time, in NL, physicians, dentists, veterinarians, nurse practitioners, and optometrists all have varying authority to prescribe. An out-of-province prescriber would have to belong to one of these groups for their prescription to be valid in this province. For example, a prescription from a dentist would be valid; a prescription from a chiropractor would not.
Pharmacists are also reminded that the onus is on them to verify the authenticity of any and all prescriptions and if he or she is ever in doubt as to the validity of the prescription or the licensing status of the prescriber, he or she should follow up with the prescriber directly and/or contact the relevant licensing authority.
- How do I request an emergency supply of a narcotic or a controlled drug from another pharmacy?
Since the Narcotic Control Regulations only allow for one pharmacist to provide a narcotic or controlled drug to another pharmacist to fulfill an emergency need, this means only the minimum amount necessary to fill an actual prescription may be provided (i.e. 26 tablets of Atasol 30 to make up a total quantity of 30 for a prescription but not 100 tablets, just in case).
- When requesting a product, the pharmacist should sign and date a written request that includes the product and the quantity needed as well as the pharmacy to where the product is going. A copy of this request should be retained by the pharmacy.
- When such a request is received by a pharmacy, they should record the provision in their perpetual inventory and retain the written request with their narcotic and controlled drug prescription files.
- When the requesting pharmacy receives the product, they should record the receipt in their perpetual inventory and file the written request along with any other documentation with their purchase records.
- What do I need to do before I destroy Narcotics and Controlled Drugs?
Health Canada recently published two guidelines on the destruction of narcotics and other controlled substances:
Questions about Prescribing by Pharmacists
- What activities are covered by the Standards of Practice – Prescribing by Pharmacists
In NL, authorized pharmacists may:
- Prescribe Schedule I, II, III or Unscheduled Drugs for a Minor Ailment
- Prescribe Schedule I, II, III or Unscheduled Drugs for a Preventable Disease
- Prescribe Schedule II, III or Unscheduled Drugs for Other Purposes
- Prescribe an Interim Supply
- Extend a Prescription
- Adapt a Prescription
- Make a Therapeutic Substitution
- Can all pharmacists prescribe?
Only pharmacists authorized by NLPB 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 (available through the NLPB Online Learning Portal) and then apply to NLPB 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. Pharmacists are to refrain from prescribing until this approval has been received.
- Are there limitations on Pharmacists’ Prescribing?
Yes, pharmacists must adhere to the following limitations:
- In accordance with the Controlled Drugs and Substances Act (Canada) and its associated regulations, a pharmacist may not prescribe Narcotics, Controlled Drugs or Targeted Substances, including benzodiazepines.
- 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”.
- A pharmacist may not prescribe for an animal.
- A pharmacist may not prescribe for themselves.
- A pharmacist should not prescribe for a family member or someone of a “close personal or emotional relationship” unless there is no alternative. If a pharmacist prescribes in these circumstances, it should be appropriately documented.
- A pharmacist may not provide an interim supply, extend a prescription, make a therapeutic substitution or adapt a prescription where the original prescription bears a specific indication otherwise.
- Pharmacists must limit their prescribing activities to those situations covered by the Standards of Practice.
- Is there a list of drugs pharmacists can prescribe for the minor ailments?
No, once a pharmacist has determined from their assessment that the condition to be treated is one of the approved minor ailments, he or she is expected to follow best practices and clinical guidelines to choose the best treatment for the patient. The only restriction on this decision would be with regard to the limitation on prescribing narcotics, controlled drugs, benzodiazepines, or targeted substances.
For pharmacists who are looking for the most recent best practices and clinical guidelines, we would suggest referring to:
- The Compendium of Therapeutics for Minor Ailments (https://www.pharmacists.ca/products-services/) – a required reference under the Standards that is a compilation of assessment and treatment algorithms, pathophysiology, pharmacological and nonpharmacological therapies and patient information for a wide variety of minor ailments.
- The website RxFiles (www.rxfiles.ca) – an academic detailing program providing objective, comparative drug information to clinicians through newsletter reviews, Q&As, Trial Summaries, and up-to-date drug comparison charts.
- The website MedSask (https://medsask.usask.ca/professional-practice/minor-ailment-guidelines.php) – the drug information centre in Saskatchewan (the first province to move forward with prescribing for minor ailments). They have developed treatment guidelines for a number of minor ailments, including mild acne, allergic rhinitis, cold sores and hemorrhoids.
- What if I am not sure of the correct therapy or have some doubts as to the diagnosis?
Again, there is no obligation for a pharmacist to prescribe. If you have determined that there is insufficient information or added risks to the patient, you should not prescribe. In these cases, pharmacists should refer the patient back to their primary health care provider or another appropriate health care professional.
- Should pharmacists have their own prescription pads? If so, is there a standardized format for the pad?
While there is no specific requirement in the Standards for pharmacists to have their own prescription pad, it is a best practice to help standardize the information on the prescription. This is especially important if the patient is taking the prescription to be filled elsewhere. In these cases, the pharmacist at the dispensing pharmacy must be able to be confident in the validity of the prescription as well as to contact the prescribing pharmacist if there are questions or issues.
With regard to the format of the pad, the forms should be large enough to contain complete information for each prescription and should be difficult to photocopy or otherwise duplicate (utilizing a watermark or other security features). The prescriber’s name, practice address, and telephone number should be preprinted on the prescription form. Pharmacists should always sign their prescriptions and include their registration number if it is not pre-printed on the pad.
- When I add an exempted codeine product to a patient’s profile, is this prescribing?
No, adding an exempted codeine product (ECP) to a patient’s profile for the purposes of meeting the record-keeping requirements of the Standards of Practice – The Sale of Exempted Codeine Products in Community Pharmacies is not considered to be prescribing.
In order to be considered prescribing, in accordance with the Standards of Practice – Prescribing by Pharmacists, a pharmacist would have to be:
- 1. initiating a prescription for a Schedule I, II, III, or Unscheduled product to treat a Minor Ailment or
- 2. initiating a prescription for a Schedule II, III, or Unscheduled product to facilitate adherence or to facilitate coverage through the patient’s third party drug benefit plan
While it could be argued that a pharmacist could prescribe an ECP for mild headache or minor joint pain under #1 above, at this time, the Prescribing Regulations and Standards specifically limit pharmacists from prescribing Narcotics, Controlled Drugs, Benzodiazepines, and Other Targeted Substances.
Questions about Administering Drug Therapy by Inhalation or Injection
- Are all pharmacists authorized to administer drug therapy by inhalation or injection?
Only pharmacists authorized by NLPB as outlined in the Standards for the Safe and Effective Administration of Drug Therapy by Inhalation or Injection (available on the Standards, Guidelines and Policies page) are authorized to administer drugs by inhalation or injection. The requirements for obtaining this authorization and the applicable authorization form can be found on the Registration and Authorization Information for Registrants page.
- Do I have to be in my pharmacy to administer an injection to a patient?
The Injection Standards do not restrict pharmacists to performing injections within a pharmacy. The Standards were written intentionally to allow pharmacists to administer in locations other than a pharmacy, referencing the “location” where the injection is administered rather than the “pharmacy”.
Having said that, the expectation is that all of the standards are still met, and administering off-site could create certain challenges that the pharmacist would have to consider.
For example, the standards require the pharmacist to ensure that the location is designed and laid out to allow for all inhalations and injections to be provided in an environment that ensures visual and acoustical privacy and confidentiality and that is clean, safe, and comfortably furnished for the patient. The area must also allow for suitable post-therapy observation and be equipped with all necessary emergency support equipment and supplies that may be required. Pharmacists administering off-site (whether that be in a private home, long-term care facility, outdoor area, etc.) would need to be sure the site meets these requirements and also consider what supplies they may need to bring with them.
Additionally, the assessment, documentation, and follow-up requirements of the standards must also be met. Pharmacists would have to plan for this and determine how they are going to meet this expectation, particularly if they need to access the electronic health record as part of their patient assessment or when completing documentation.
- What types of supplies should I have on hand?
A pharmacist must have ready access to all necessary supplies for the administration of injections as well as the drugs and supplies that would be required to treat emergencies or adverse reactions associated with the administration of drug therapy. Information on this is provided during the education and training program, as well as in the Canadian Immunization Guide. In Part 2 of this guide, under “Early vaccine reactions including anaphylaxis”, it gives a list of recommended items in an anaphylaxis management kit.
Based on this list, as well as other resources, the following is recommended as a minimum:
- Anaphylaxis treatment guidelines
- Laminated table of dosage recommendations for epinephrine and diphenhydramine hydrochloride by weight and by age
- Vials of aqueous epinephrine 1:1000
- Vial of injectable diphenhydramine hydrochloride
- A range of autoinjectors of epinephrine labelled by age and weight
- 1 cc syringes with attached needles 25 gauge,1 inch needle and 25 gauge, 5/8 inch needle)
- One extra 25 gauge, 5/8 inch needle only
- Two extra 25 gauge, 1 inch and 1.5 inch needles only (for larger adults)
- Ice or cold compress
- Resuscitator bag / equipment to maintain airways
- What reporting is expected in the event of an adverse reaction to an immunization?
The Public Health Agency of Canada requires that all health professionals report any major or moderate adverse events that occur following the administration of an immunization, using the Adverse Events Following Immunization Guidelines and reporting form (available at http://www.phac-aspc.gc.ca/im/aefi-essi-form-desc-eng.php). Once completed, the form is to be submitted to the Division of Communicable Disease Control at the Department of Health and Community Services. More information on this division can be found on the Department of Health and Community Services website.
- Can the Inhalation or Injection Administration Documentation & Notification Form found in Appendix II of the Standards be modified?
Yes, this form is provided as a template so it may be modified to suit the purposes of the pharmacy. Having said that, all information on the template MUST also be included on the customized form(s).
- How should I file the documentation and notification forms afterwards?
There are several ways this could be accomplished but the main thing you must ensure is that they are retrievable, if needed. An appropriate way to handle these forms would be to file them in sequential order along with your other prescriptions since each instance of administration will likely generate a prescription/transaction number. You could then attach your computer “hard copy” to the form and file it. Pharmacies that have scanning technology can also scan these forms and attach them to the patient’s file for future reference.
- Can pharmacy students or interns administer drugs by inhalation or injection?
Yes, as long as they meet certain criteria set out by NLPB in the Practice Policy-Pharmacy Students/Interns Administering Inhalations or Injections. In accordance with this policy, the pharmacy student or intern MUST:
- be 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
- be 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 or 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.