Frequently Asked Questions About Pharmacy Practice

Please click the link below to bring you to the appropriate section:

 

General Pharmacy Practice Questions

  • Which professionals are permitted to prescribe in Newfoundland and Labrador (NL)?
    At this time, dentists, nurse practitioners, optometrists, pharmacists, physicians, registered nurses, and veterinarians all have varying authorities to prescribe in NL.To verify the current status of a prescriber in NL, you can visit the website for that profession’s provincial regulatory body.

 

  • 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, 2012 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 things to consider.First, the person must belong to a class of professionals authorized to prescribe in NL. At this time, dentists, nurse practitioners, optometrists, pharmacists, physicians, registered nurses, and veterinarians all have varying authorities to prescribe in NL. 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.Pharmacy professionals are also reminded that the onus is on them to verify that prescriptions are current, authentic, complete, and appropriate before dispensing. This may include validating that the prescriber is appropriately registered and authorized to prescribe, or verifying that the prescription is written in accordance with any applicable legislation, both federal and provincial, including the Tamper Resistant Prescription Drug Pad Program, if applicable.

 

  • What methods of prescription transmission are acceptable?
    As new technologies emerge and patient expectations change, there has been a shift in how prescriptions are transmitted from prescriber to pharmacy. Although there are many different methods in use, regardless of the method, pharmacy professionals are still expected to ensure that prescriptions are current, authentic, complete, and appropriate before dispensing. Additionally, pharmacy professionals have to meet the expectations of the Personal Health Information Act and the NLPB Code of Ethics, with respect to patient privacy and security of personal health information.
    Acceptable methods could include:

    • Prescriptions that are handwritten and signed by the prescriber and then either given to the patient to bring to their pharmacy or faxed directly to a pharmacy from the prescriber in accordance with section 3.3 of the Standards of Pharmacy Operation – Community Pharmacy.
    • Prescriptions that are generated electronically, printed, and hand-signed by the prescriber and then either given to the patient to bring to their pharmacy or faxed directly to a pharmacy from the prescriber in accordance with the Standards of Pharmacy Operation.
    • Prescriptions that are generated electronically by a prescriber’s password-protected electronic medical record (EMR) and sent directly to a pharmacy from that system.

    At this time, prescriptions for drugs referenced in section 4 of the Pharmaceutical Services Regulations – i.e. the “Drugs Required to be Written on Tamper Resistant Pads” – must still be written on the required pad before either being given to the patient to bring to their pharmacy or faxed directly to a pharmacy from the prescriber in accordance with the Standards of Pharmacy Operation.

    What about apps or other technologies that allow a patient to send a picture of their prescription to the pharmacy?

    If a patient uses an app, text message, or email to provide the pharmacy with an image of a prescription, pharmacy team members may use the image to see if stock is available, offer an estimation on cost, or confirm third-party drug coverage.

    However, images of a prescription are not equivalent to an original prescription and should not be used to prepare prescriptions in advance of receiving the original copy.  Doing so increases the risk of error as well as the possibility of creating inaccurate or duplicate records within the electronic health record (EHR).

    With more and more health professionals relying on the real-time information provided in the EHR, the integrity of the record is more important than ever, and pharmacy professionals have a responsibility to ensure the accuracy of the information they transmit to the EHR.

    Pharmacy owners and pharmacists in charge are responsible for assessing whether new technologies comply with provincial legislation and standards of pharmacy practice before offering them to patients.  This includes considering whether a Privacy Impact Assessment may be necessary, in accordance with the guidance given by the Office of the Information and Privacy Commissioner (OIPC).

 

  • 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 Pharmacy Technician Practice

 

 

  • 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 consultation, as required.It cannot be assumed that the 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, and 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:

    • Patient
    • Drug, Dosage Form, Route, Dose and Quantity
    • Directions
    • Prescriber
    • Container/Packaging/Labelling

    However, pharmacists remain responsible for reviewing the patient’s local and provincial electronic health record profiles, and taking appropriate action, where applicable, with respect to::

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

    During this process, the pharmacist is also expected to assess whether the patient requires additional consultation, taking into account:

    • how long the patient has been taking the medication;
    • whether there has been a change to the dosage, dosage form, or appearance of the medication since the last fill;
    • whether the prescription is for a “high-alert” medication or medication that requires increased monitoring;
    • the patient’s history with the medication including timeliness of refills, side effects, etc.; and
    • whether the patient has been given sufficient opportunity to ask questions or discuss potential issues

    Dispensing records should include 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 provided the patient with consultation and the date that the consultation took place.

 

 

Questions about Pharmacy Intern Practice

  • What can I do as an intern – what is my scope?
    As per the Pharmacy Act, 2012, 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. The scope of activities a pharmacy 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 interns are not permitted to do?
    Certain aspects of pharmacy practice currently require authorization from NLPB prior to being able to participate in that practice. These include:

    • administering inhalations or injections
    • prescribing

    Pharmacy interns cannot currently be authorized to perform these scopes and therefore 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 are under 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 out of their learning experience.

    With regards specifically to administering inhalations and injections, the NLPB Standards of Practice – Administration of Drug Therapy by Inhalations or Injections does describe circumstances under which a pharmacy intern or pharmacy student may administer drug therapy by inhalation or injection. It states that, once a pharmacist determines that it is appropriate for a patient to receive the drug therapy by inhalation or injection, a pharmacy intern or pharmacy student may administer the drug therapy as long as the pharmacy intern or pharmacy student:

    • has successfully completed education and training and certification in First Aid and CPR in accordance with section 2) a) of the Standards;
    • is appropriately registered with NLPB, including having current professional liability insurance; and
    • is under the direct supervision of a pharmacist who has received authorization from NLPB to administer drug therapy by inhalation or injection in accordance with section 2) b) of the Standards.

    When providing direct supervision, the pharmacist must be present when the activity is being performed and able to observe and promptly intervene to stop or change the actions of the individual being supervised. The pharmacist remain responsible and accountable for the administration of the drug therapy to the patient.

 

  • Can an intern be independently accountable for the clinical verification or final product check of a prescription?
    As per the Pharmacy Act, 2012, 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 and 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 Standards of Pharmacy Operation 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;
    • the requirements of the provincial Prescription Monitoring Program and
    • 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

  • What is the Health Canada Subsection 56(1) Class Exemption?
    Essentially, under subsection 56(1) of the Controlled Drugs and Substances Act (“CDSA”), the federal Minister of Health has the ability to grant special permissions related to controlled substances if they feel it is in the best interest of the public to do so. In this case, Health Canada has issued a Subsection 56(1) Class Exemption (“the exemption”) that exempts practitioners and pharmacists, authorized within their scope of practice, from certain sections of the CDSA and its regulations when prescribing, selling, or providing a controlled substance to a patient or transferring a prescription for a controlled substance to a pharmacist in Canada. In addition to the information provided below, pharmacy professionals can also refer to Health Canada’s FAQ on the Subsection 56(1) Class Exemption.In accordance with the federal legislation, “controlled substances” are defined as narcotics, controlled drugs, benzodiazepines and other targeted substances.

    The exemption is in effect until the earliest of the following dates:

    • September 30, 2026;
    • The date that it is replaced by another exemption; or
    • The date on which it is revoked

    For the duration of the exemption, NL pharmacists CAN:

    • Accept verbal prescriptions for controlled substances from authorized prescribers;
    • Prescribe an interim supply or extend a prescription for a controlled substance within the framework of the NLPB Standards of Practice-Prescribing by Pharmacists (“Prescribing Standards”) as long as the prescription can be filled at the pharmacy where the prescribing pharmacist is located at the time it is written;
    • Send or receive a prescription transfer for a narcotic or controlled drug to another pharmacist within Canada;
    • Send or receive a prescription transfer for a benzodiazepine or targeted substance more than once; or
    • Delegate another appropriate individual to deliver controlled substances to a patient’s home or another location.

    PLEASE NOTE:

    • Pharmacy technicians are NOT currently permitted to transfer prescriptions for controlled substances under the federal legislation.
    • Despite the exemption, NL pharmacists still CANNOT:
      • Initiate prescriptions for controlled substances;
      • Adapt prescriptions for controlled substances; or
      • Make a therapeutic substitution for controlled substances.

     

  • What has the Health Canada Subsection 56(1) Exemption changed regarding the delivery of controlled substances?
    Typically, NL pharmacists are permitted to deliver controlled substances to patients and community health facilities when necessary, providing that NLPB delivery standards are met. In 2019, Health Canada issued guidance and an exemption specifically related to this issue:

    This exemption allows pharmacists to delegate the delivery of controlled substances to pharmacy team members and other appropriate individuals. In addition to NLPB’s usual delivery standards, the Health Canada exemption requires that any individual delivering controlled substances carries a copy of the Health Canada exemption and a written note from a pharmacist that identifies the name of the person doing the delivery, the name of the controlled substance to be delivered and the place of delivery (drug information may be contained within the package to preserve patient confidentiality) while carrying out the delivery.

    Pharmacists must ensure patients provide consent to the delivery (including the sharing of necessary personal health information); verbal consent is acceptable.

    It is expected that all reasonable steps will be taken to protect against loss or theft and that there are processes in place to verify that the medication has reached the patient for which it is intended.

 

  • 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

  • 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 applying for authorization, in accordance with the instructions given on the Authorization for Registrants page. 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.

 

  • Is there a list of drugs pharmacists can prescribe for approved ailments and conditions?
    No, once a pharmacist has determined from their assessment that the condition to be treated is one of the approved ailments or conditions, they are 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 best practices and clinical guidelines, we would suggest referring to:

 

  • What if I am not sure of the correct therapy or have some doubts as to the diagnosis?
    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.

 

Questions about Administering Drug Therapy by Inhalation or Injection

 

  • Where can I access an acceptable injection education and training program?
    The Canadian Council on Continuing Education in Pharmacy (CCCEP) provides competency-mapped accreditation for injection education and training programs and maintains a list of programs that currently have accreditation on their website at: https://www.cccep.ca/pages/immunization_and_injections.html.

 

  • Once I am authorized to administer injections, what requirements am I expected to meet?
    The Administration Standards state that once authorized, pharmacists and pharmacy technicians must:

    • maintain competence and skill level in administering inhalations or injections;
    • maintain appropriate CPR and First Aid certification; and
    • administer inhalations and injections only in accordance with provincial guidelines, standards established by the NLPB, and within the limits of their own competence.

    NLPB often gets questions about the first bullet listed above. Generally, in the past, NLPB has advised pharmacy professionals seeking information about maintaining competence in the absence of regularly administering to register for and complete a formal refresher program through an accredited provider. Unfortunately, as time has gone on the demand for these programs has waned and they are not as readily available. As such, we now advise pharmacy professionals to:

    • ensure clinical competency by participating in self-study – review the online learning modules, the latest Immunization Guides, and product monographs for the medications/vaccinations that they intend to administer; and
    • ensure technical competency by re-completing the live portion of the accredited program, shadowing another pharmacy or health professional, and/or asking that pharmacy or health professional to observe your technique and offer feedback.

    Once authorized, it is ultimately up to the pharmacy professional to ensure that they continue to meet the requirements of the Standards and, if not, to refrain from administering until such time as they are able to address the deficiency.

 

  • Do I have to be in a pharmacy to administer an injection to a patient?
    The Administration Standards do not restrict pharmacy professionals to administering injections within a pharmacy. The Standards were written intentionally to allow injections to be administered in locations other than a pharmacy, referencing the “physical environment” where the injection is administered rather than the “pharmacy”. Having said that, the expectation is that all of the standards are still met, and, as such, certain things will need to be taken into consideration when planning to administer off-site. For example, the Standards require that the environment where administrations take place takes patient privacy into account, is clean, safe, suitably furnished and equipped, and is suitable for post-therapy observation. Pharmacy professionals 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. Prior planning would be required to determine how these requirements will be met, particularly if access to the electronic health record is required as part of patient assessment or when completing documentation.

 

  • What types of supplies should I have on hand?
    Pharmacy professionals 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. Specific 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 “Anaphylaxis and other Acute Reactions following Vaccination”, pharmacists can find a list of recommended items for an anaphylaxis management kit.

 

  • What reporting is expected in the event of an adverse reaction to an immunization?
    The Public Health Agency of Canada and the NL Department of Health and Community Services require that health professionals report any major or moderate adverse events that occur following the administration of an immunization. This can be accomplished by following the direction given in Section 1 of the Newfoundland and Labrador Immunization Manual.

 

  • Can pharmacy students or interns administer drugs by inhalation or injection?
    The NLPB Standards of Practice – Administration of Drug Therapy by Inhalations or Injections does describe circumstances under which a pharmacy intern or pharmacy student may administer drug therapy by inhalation or injection. It states that, once a pharmacist determines that it is appropriate for a patient to receive the drug therapy by inhalation or injection, a pharmacy intern or pharmacy student may administer the drug therapy as long as the pharmacy intern or pharmacy student:

    • has successfully completed education and training and certification in First Aid and CPR in accordance with section 2) a) of the Standards;
    • is appropriately registered with NLPB, including having current professional liability insurance; and
    • is under the direct supervision of a pharmacist who has received authorization from NLPB to administer drug therapy by inhalation or injection in accordance with section 2) b) of the Standards.

    When providing direct supervision, the pharmacist must be present when the activity is being performed and able to observe and promptly intervene to stop or change the actions of the individual being supervised. The pharmacist remain responsible and accountable for the administration of the drug therapy to the patient.

 

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. If they have designated another person, this person works with the PIC, pharmacy management, and compounding personnel to develop, organize, and oversee all activities related to the given area of compounding. The PIC must still ensure that 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. If the compounding supervisor does not carry out their responsibilities for any reason, the PIC must assume the responsibilities of the compounding supervisor.

 

  • 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. 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 5.1.1.2 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 just be whatever pharmacist/pharmacy technician is 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.

 

  • Does NLPB approve facility design?
    When a renovation is necessary, 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 any 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. PICs 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.

 

Scroll to Top