Pharmacy Standards of Practice for First Nations and Inuit Health Branch
Health Facilities
2001
ISBN: 0-662-66080-3
Cat. No.: H35-4/17-2001
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Table of Contents
The purpose of the Pharmacy Standards of Practice for the First Nations
and Inuit Health Branch (FNIHB) Health Facilities is to outline the minimal
requirements for the safe and effective provision of pharmacy services
to clients in First Nations communities, serviced by First Nations and
Inuit Health Branch. Pharmacy services are provided by nurses/pharmacists
working in these settings. These Standards attempt to address the uniqueness
of practice in the FNIHB health facilities, often influenced by their
remote locations. In the majority of health facilities, nurses with expanded
scope of practice are responsible for drug distribution and these standards
recognize their training, background and role. Although the roles and
the responsibilities of the employer (FNIHB) in supporting the maintenance
and enforcement of these Pharmacy Standards are not directly stated throughout
the document, it is understood that the environment for the safe delivery
of drugs is in place (i.e., adequate and appropriate staffing, adequate
physical facilities, etc.) and that this is the responsibility of the
employer.
The safe and effective provision of drugs encompasses several basic
principles--including the knowledge base and competence of the individual
who is distributing drugs; patient counselling; and the drug distribution
system which includes the receiving, storage, distribution and disposal
of drugs. These Standards outline the minimal requirements for providing
safe and effective drug therapy.
In these Standards of Practice, each Standard and subsequent operational
component relates to the basic principles and forms the basis for the
provision of pharmacy services. The operational components, accompanying
each Standard, are intended to assist with the implementation of the
Standard and at the same time allow for professional judgment when required.
It is recognized that because of the changing nature of health care,
the Standards and accompanying operational components should be reviewed
on a regular basis.
The following standards are adapted with permission from the Model Standards
of Practice for Canadian Pharmacists, developed by the National Association
of Pharmacy Regulatory Authorities (NAPRA) and approved by the NAPRA
Council in April 1998.
Summary of Standards
Standard #1: Professional Responsibilities
The nurse/pharmacist, using unique professional knowledge
and skills to meet a client's drug-related needs, practices client-focused
care in partnership with clients and other health care providers,
to achieve positive health outcomes and/or to maintain or improve
quality of life for the client.
1.1 Professional Relationships
1.2 Client History
1.3 Selection of Drug Therapy
1.4 Therapeutic Options
1.5 Client Referral
1.6 Monitoring and Evaluating Therapeutic Outcomes
1.7 Documentation
1.8 Adverse Reactions
1.9 Medication Errors
1.10 Toxic Drug Effects
Standard #2: Legal and Ethical Responsibilities
The nurse/pharmacist practices within legal requirements
and ethical principles, demonstrates professional integrity, and
acts to uphold professional nursing and pharmacy standards of practice.
2.1 Scope of Practice
2.2 Ethical Responsibility
2.3 Professional Integrity
2.4 Competence
Standard #3: Drug Information
The nurse/pharmacist identifies, consults, retrieves, evaluates,
interprets and provides appropriate drug and pharmacy practice information
to achieve safe and effective patient care.
3.1 Sources
3.2 Retrieval
3.3 Evaluation
3.4 Provision
Standard #4: Communication
While respecting the patient's right to confidentiality,
the pharmacist/nurse communicates and educates to provide optimal
patient care and promote health.
4.1 Confidentiality
4.2 Communication Skills
4.3 Record of Dialogue
4.4 Providing Drug Information to Client
4.4.1 Releasing of Medications to Other than Client
4.4.2 Assessment of Client's Level of Understanding
4.5 Over-the-Counter (OTC) Medication
4.5.1 Provision of OTCs by Non-Professional Staff
Standard #5: Management of Drug Distribution
The nurse/pharmacist manages drug distribution by performing,
supervising or reviewing the functions of selection, preparation,
distribution and storage of drugs to ensure safety, accuracy and
quality of supplied products.
5.1 Security and Storage
5.2 Distribution
5.2.1 Relevant Knowledge
5.2.2 Labelling
5.2.3 Disposal
5.3 Delegation of Distribution Activities
5.4 Extemporaneous Preparations
5.5 Clients' Unused Drugs
5.6 Record Keeping
5.7 Time Frame for Valid Prescriptions
Standard #6: Pharmacy Operations
The nurse/pharmacist applies knowledge, principles and skills
of management as they pertain to the site of pharmacy practice, with
the goal of optimizing patient care and interprofessional relations.
6.1 Management Activities
6.2 Staffing
6.3 In-Service Education
6.4 Policies and Procedures
6.5 Access to Professional Consultation
Note: While the competence, knowledge, skills and procedures, required
for the delivery of safe and effective pharmacy services lie with the
health care professional, the management/employer must ensure that an
appropriate environment is in place for the health care providers to
meet this objective. Thus, the role of the employer is implied in each
of the following standards.
Standard #1: Professional Responsibilities
The nurse/pharmacist, using unique professional knowledge
and skills to meet a client's drug related needs, practices client-focused
care in partnership with clients and other health care providers,
to achieve positive health outcomes and/or to maintain or improve
quality of life for the client.
1.1 Professional Relationships
The nurse/pharmacist develops a professional relationship with the
client:
- to determine the client's needs, values, desired level of care and
desired
outcomes regarding drug therapy, and
- to establish the mutual responsibility of each participant.
The nurse/pharmacist:
1.1.1 ...establishes and maintains rapport by using effective communication
skills to initiate dialogue. Effective communication includes:
- listening, speaking and writing skills;
- sensitivity to nonverbal forms of communication;
- sensitivity to language barriers; and
- sensitivity to diversity/cultural background in the community.
1.1.2 ...demonstrates a caring and professional attitude.
1.1.3 ...elicits the needs, values, desired level of care and desired
outcomes of the client.
1.1.4 ... assesses the impact of factors that facilitate or impede
the health of individual clients.
1.1.5 .discusses with the client the responsibilities of the client,
the nurse/pharmacist and other health care providers in health care management
and outcomes, outlining the benefits of acceptance of these responsibilities
and the consequences of not accepting these responsibilities.
1.2 Client History
The nurse/pharmacist gathers and records appropriate information to
establish a client database for the provision of client-focused care,
and maintains such information in a manner, specified in the employer's
procedures for documentation, which ensures ease of use for client care
activities and confidentiality for the client.
The nurse/pharmacist:
1.2.1 ...establishes or has access to a database containing relevant
information about the client's health, including but not limited to:
- the background and past and current history that may be related to
the client's current condition;
relevant family medical history;
- relevant social history (i.e. alcohol, nicotine use);
- the current condition or symptoms being treated and the clinical
diagnosis of the situation;
- the history of current disease states (as they relate to the condition
being treated);
- known client risk factors for adverse drug reactions, drug allergies
or sensitivities;
- known contraindications to prescription or nonprescription drug
use;
- dietary restrictions; and
- other medications or treatments the client is currently taking that
may contribute to this condition or interact with suggested therapy.
1.2.2 .assesses and identifies such factors as financial constraints,
lifestyle, nutrition, drug use and client's motivation to take drugs
that impact on the drug therapy, health problem or condition of the client.
1.3 Selection of Drug Therapy
The nurse/pharmacist interacts with the client to identify the desired
outcomes of drug therapy and critically evaluates the client's drug therapy
and identifies potential and actual drug-related problems with the client.
The nurse/pharmacist:
1.3.1 ... integrates knowledge of the health status of the client
with knowledge of pharmacotherapies and non-drug treatment options to
evaluate and describe the possible outcomes of pharmacotherapy.
1.3.2 ...encourages and supports the client's right to make choices.
1.3.3 ...determines whether the client needs the drug, requires
drug therapy and is not receiving it, or is receiving the wrong drug.
1.3.4 ...determines if the correct amount of the drug is being
received and taken appropriately.
1.3.5 ...recognizes and takes steps to avoid or minimize adverse
outcomes of drug interactions.
1.3.6 ...recognizes and takes steps to avoid or minimize side
effects, toxicity, and adverse drug reactions.
1.3.7 ...recognizes and addresses patterns of inappropriate use
of drugs.
1.3.8 ...detects and responds appropriately to activities which
would divert drugs from their intended legitimate use.
1.3.9 ...provides appropriate information to facilitate the client's
understanding of his or her drug therapy and ability to comply with the
therapy regimen.
1.4 Therapeutic Options
In consultation with the client and/or other health care providers,
the nurse/pharmacist determines the appropriate therapeutic options to
solve or prevent the identified drug-related problems, including non-drug,
nonprescription and prescription drug therapies.
The nurse/pharmacist:
1.4.1 ...prioritizes identified drug-related problems.
1.4.2 ...proposes and assesses alternative strategies, including
non-drug and drug therapies.
1.4.3 ...establishes a positive working relationship with health
care providers in order to meet the objective of positive health care
outcomes.
1.4.4 ...selects with the client and/or through consultation with
other health care providers the most appropriate therapeutic option.
1.4.5 ...explains the rationale of the proposed treatment to the
client.
1.5 Client Referral
The nurse/pharmacist refers the client to the appropriate health care
provider or health care agency after determining with the client if such
a referral is necessary.
The nurse/pharmacist:
1.5.1 ...is aware of available health care resources and agencies.
1.5.2 ...is knowledgeable of necessary procedures in making referrals
to other health care resources and agencies.
1.5.3 ...accesses other appropriate resources and agencies as needed.
1.6 Monitoring and Evaluating Therapeutic Outcomes
When the nurse/pharmacist or client identifies a drug-related need,
the nurse/pharmacist in collaboration with the client/caregiver develops
and implements a plan to evaluate therapeutic outcomes and then monitors
and evaluates the therapy.
The nurse/pharmacist:
1.6.1 ...identifies important clinical indicators (signs and symptoms).
1.6.2 ...identifies and applies appropriate monitoring techniques.
1.6.3 ...establishes an effective plan which includes the onset,
frequency and duration of monitoring.
1.6.4 ...involves the client/caregiver in the implementation and
maintenance of the plan.
1.6.5 ...defines measurable therapeutic outcomes in consultation
with the client and/or health care professionals if required.
1.6.6 ...discusses the responsibilities of the nurse/pharmacist,
client and other health care providers.
1.6.7 ...collects and interprets pertinent information from clients
and health care providers.
1.6.8 ...assesses client outcomes.
1.7 Documentation
The nurse/pharmacist maintains client documentation in a readily retrievable
format, consistent with the employer's standards for client documentation.
The nurse/pharmacist:
1.7.1 ...is aware of the purpose(s) for the documentation.
1.7.2 ...maintains a client information database which includes
a medication profile and pertinent medical history.
1.7.3 ...records the client's current problems and priority for
resolution.
1.7.4 ...documents the actual intervention.
1.7.5 ...documents the client's outcome and follow-up assessment.
1.7.6 ...documents communication with the client and other health
care providers.
1.8 Adverse Drug Reactions
The nurse/pharmacist documents and reports any adverse drug reactions
to the prescriber and other health care providers as appropriate, and
complies with formal adverse drug reaction reporting programs. Completed
forms (blank forms are included in the lilac section of the Compendium
of Pharmaceuticals and Specialties and are available on the web at www.hc-sc.gc.ca/hpb-dgps/therapeut/
zfiles/english/forms/adverse_e.pdf) should be forwarded to the appropriate
Regional Adverse Drug Reaction Centre as identified on the form. Proof
that a drug has caused an undesirable patient effect is not a requirement
for reporting an adverse drug reaction. If an adverse event is suspected
of being drug related, particularly if the event is unusual in the context
of the illness, it should be reported.
The nurse/pharmacist:
1.8.1 ...notifies the client of allergies or hypersensitivities
that may occur and mechanisms to avoid recurrence, including when appropriate,
written documentation and advice to wear "Medic Alert" or similar bracelets.
1.9 Medication Errors
The nurse/pharmacist documents medication errors as per employer's
requirement and discusses the error with the client, prescriber and other
health care professionals, as appropriate, resolve drug-related problems
resulting from drug errors and implements appropriate follow-up according
to the employer's policy.
The nurse/pharmacist:
1.9.1 ...assumes responsibility for recognizing drug errors.
1.9.2 ...takes the necessary steps to resolve issues arising through
medication discrepancies and errors, including the notification of appropriate
personnel, and implements measures to prevent recurrence.
1.10 Toxic Drug Effects
The nurse/pharmacist shall be knowledgeable about the toxic effects
of drugs.
The nurse/pharmacist:
1.10.1 ...shall use child-resistant containers for solid dosage
forms except when it is not advisable or suitable.
1.10.2 ...shall promote poison prevention and shall have information
about how to contact poison control centres for information in the event
of an accidental poisoning or overdose.
Standard #2: Legal and Ethical
Responsibilities
The nurse/pharmacist practices within legal requirements
and ethical principles, demonstrates professional integrity, and
acts to uphold professional nursing and pharmacy standards of practice.
2.1 Scope of Practice
The nurse/pharmacist complies with legal requirements and ethical principles
of practice including federal and provincial legislation governing the
sale of drugs and in addition the nurse complies with FNIHB standards
of practice with respect to providing medications, including the Nurses
Drug Classification System which provides a framework for nurses practising
within the expanded Scope of Practice.
The nurse:
2.1.1 ...dispenses only those drugs identified in the Nurses Drug
Classification System.
2.1.2 ...may be further limited in dispensing by regional/agency
formularies within the context of the Nurses Drug Classification System.
2.2 Ethical Responsibility
The nurse/pharmacist upholds and acts on the ethical principle that
the primary
accountability of the nurse/pharmacist is to the client, with respect
to:
- client confidentiality;
- involvement of the client in the decision-making process; and
- respect for the right of clients to make their own choices.
The nurse/pharmacist:
2.2.1 ...in the course of fulfilling their duty of care for the
client, the nurse/pharmacist has the right to refuse to provide a product
or service when in her/his professional judgement provision is inappropriate,
for example, unsafe for client; client has demonstrated overuse of drug;
a physician's order is pending.
2.3 Professional Integrity
The nurse/pharmacist demonstrates personal and professional integrity;
and:
2.3.1 ...accepts responsibility for his or her actions and decisions.
2.3.2 ...shows respect for the dignity of the client.
2.3.3 ...maintains appropriate interprofessional relationships.
2.3.4 ...recognizes and practices within his or her personal abilities.
2.4 Competence
The nurse/pharmacist continuously strives to gain knowledge and maintain
professional competence.
The nurse/pharmacist:
2.4.1 ...identifies learning needs and seeks, evaluates and participates
in learning opportunities to meet these needs to enhance practice through
education and experiential learning.
2.4.2 ...maintains a knowledge base on: drugs, including but not
limited to pharmacology, clinical uses, dosage forms and regimens, side
effects, contraindications, interactions, factors affecting action, etc.;
therapeutics; devices; nonmedical use of drugs; legal requirements.
Standard #3: Drug Information
The nurse/pharmacist identifies, consults, retrieves, evaluates,
interprets and provides appropriate drug and pharmacy practice information
to achieve safe and effective care.
3.1 Sources
The nurse/pharmacist identifies and evaluates appropriate sources of
relevant information. A list of examples (but not limited to) of resources
is attached as Appendix I.
3.2 Retrieval
The nurse/pharmacist consults and retrieves information from relevant
sources using a variety of retrieval techniques.
3.3 Evaluation
The nurse/pharmacist determines the credibility of information sources
and critically evaluates drug information from the various sources.
3.4 Provision
The nurse/pharmacist provides drug information to maximize the therapeutic
outcomes of drug therapy.
The nurse/pharmacist:
3.4.1 ....identifies client groups requiring such information.
3.4.2 ...determines the critical content to be provided/shared.
3.4.3 ...applies appropriate methods for providing information,
including the use of appropriate printed material, e.g., printed hand-outs
or package inserts.
3.4.4 ...assesses outcomes of providing the information.
Standard #4: Communication
While respecting the client's right to confidentiality,
the pharmacist/nurse communicates and educates to provide optimal
care and promote health.
4.1 Confidentiality
The nurse/pharmacist respects the client's rights to confidentiality
and privacy by ensuring that personal health information is communicated
in a manner in which the discussion cannot be overheard by others.
The nurse/pharmacist:
4.1.1 ...respects the confidences of the client and protects the
information received as privileged communication between a client and
a health care provider.
4.2 Communication Skills
The nurse/pharmacist:
4.2.1 ...communicates using effective and appropriate communication
skills (verbal, nonverbal, listening, and writing) while respecting the
client's cultural and ethnic background, education and other variables.
4.2.2 ...demonstrates sensitivity, respect and empathy when communicating
with clients, their families, and other health care providers.
4.3 Record of Dialogue
As part of the nurse/pharmacist dialogue with the client, the nurse/pharmacist
consults, reviews and updates the client information database/chart.
4.4 Providing Drug Information to Client
The nurse/pharmacist takes reasonable steps to communicate with the
client regarding any prescribed drug or medical device to be given to
that client. Such communication includes, but is not necessarily limited
to, a confirmation of the:
- identity of the client;
- drug allergy status;
- name, general description of the drug or device issued, and directions
for use, including duration of use;
- the intended therapeutic response;
- common or important side effects and appropriate management;
- storage requirements; and
- mandatory patient package inserts (must be supplied with drugs listed
in
Appendix II).
4.4.1 ...Release of Medications to Other than Client
If the prescribed drug is being released to a person other than the client
or for delivery to another premises, the nurse/pharmacist takes reasonable
steps to:
- confirm that the person is acting on behalf of the client;
- provide the client with the necessary information if the nurse/pharmacist
is satisfied that it is in the client's best interest to do so;
- where possible, communicate by telephone or other electronic means
with the client, regarding the release of the prescribed drug and relevant
information about it; and
- document outcome on chart.
4.4.2 ...Assessment of Client's Level of Understanding
The nurse/pharmacist endeavours to judge the level of the client's understanding
and feelings, regarding the use of the medication/drug, in order to
facilitate effective communication, and uses reasonable means to comply
with the intent of this standard.
4.5 Over-the-Counter (OTC) Medications
When a client is seeking to self-medicate with an over-the-counter
drug, the nurse in the non-treatment health facility provides the drug
only after the following criteria have been met:
- the client has been assessed as to the need for the drug;
- the possibility of allergies and interactions has been addressed;
- the side effects and precautions have been explained;
- the client assessment and medication provided is recorded in the
client's confidential health record;
- only enough medication will be given to the client to alleviate a
minor problem or until the client can be assessed by a physician (maximum
of 2 - 3 days); and
- any medication provided from the non-treatment health facility must
be included on the OTC Medication List for Non-Treatment Health Facilities
(see Appendix III).
4.5.1 ...Provision of OTCs by Non-professional Staff
Where non-professional staff (e.g., Community Health Representatives)
provide over-the-counter medication to clients the following conditions
must be met:
- sufficient initial and ongoing training must be provided to the
staff;
- scope of drugs provided will be limited to those in the OTC Medication
List for Non-Treatment Health Facilities;
- consultation with a professional health care provider must occur;
and
- employer policies and procedures must be in place to guide the non-professional
staff.
Standard #5: Management of Drug Distribution
The nurse/pharmacist manages drug distribution by performing,
supervising or reviewing the functions of selection, preparation,
distribution and storage of drugs to ensure safety, accuracy and
quality of supplied products.
5.1 Security and Storage
The nurse/pharmacist ensures that all drugs are located in a secure/locked
area of the health facility where there is no public access and only
authorized personnel are allowed entry. This must be a windowless room.
The nurse/pharmacist shall:
5.1.1 ...ensure that all drugs are stored under proper conditions
of sanitation, temperature, light, humidity and ventilation.
5.1.2 ...ensure that drugs and disinfectants for external use
are stored separately from internal and injectable medications.
5.1.3 ...arrange the drugs in a systematic manner (e.g., alphabetically
by generic name) to allow for efficient and accurate dispensing and to
enhance inventory management.
5.1.4 ...ensure that flammable and hazardous products are stored
in an appropriate storage area.
5.1.5 ...ensure that narcotics and controlled drugs are stored
in a double-locked cupboard to prevent loss or theft. Keys or combinations
for the narcotic and controlled drug lockup should be kept in a different
area from the lockup. Keys should never be left unattended.
5.1.6 ...ensure during periods of temporary closure of health
facilities (for example, during threat of forest fires or floods), narcotics
and controlled drugs and their records shall be made secure according
to the employer's policies and procedures.
5.1.7 ...ensure that client-specific medications sent to facilities
by community pharmacies for distribution to clients are stored in the
pharmacy/medication room or room with no public access until they are
issued to the clients.
In situations where the nurse/pharmacist has contacted the pharmacy
to arrange for refills of chronic medications, he/she must ensure that
the medication is still required, that the interval from the last time
the prescription was filled is appropriate, that any changes to the prescription
are transmitted to the community pharmacist, that upon issuing the filled
prescription to the client, it is for the right person and that all information
about the refill is recorded in the clients chart. In situations where
a physician contacts the community pharmacist to fill a prescription
for a client and the drug is delivered to the nursing station for pick-up
by the client, the nurse/pharmacist must ensure that the medication is
issued to the right person and that this is recorded in client's chart.
The delivery of client-specific drugs to health facilities for distribution
to clients should only be done when no other alternatives exist; otherwise
the drug should be delivered directly to client.
5.1.8 ...ensure that physician's drug samples are not stored in
the FNIHB health facilities nor distributed by the nurse/pharmacist to
clients. Physician's drug samples are the responsibility of the physician
who must ensure their safe storage and distribution.
5.2 Distribution
The nurse/pharmacist performs, supervises and reviews drug distribution
activities according to federal and provincial regulations and drug distribution
policies and procedures, established by the region (health facility).
The nurse/pharmacist:
5.2.1 ... applies relevant knowledge in the identification and
resolution of problems related to:
- interpretation of prescription medication orders--including evaluation
for accuracy, completeness, appropriateness and authenticity;
- drug interactions and adverse reactions;
- identifying generic and brand names;
- regional formulary and Non-Insured Health Benefits Drug Benefit List;
- pharmaceutical calculations;
- selection of ingredients;
- acquisition of pharmaceuticals;
- dispensing;
- preparation of sterile products; and
- storage, handling conditions and stability.
5.2.2 ...ensures that prescriptions are clearly labelled and easily
read, preferably typed or computer-generated. The label shall include:
- client's name;
- generic drug name and strength and name of manufacturer;
- directions for use;
- quantity dispensed;
- expiry date when applicable;
- date that drug is dispensed;
- name of prescriber;
- name, address, telephone number of location from which drug is dispensed;
- prescription number for filing prescriptions where applicable; and
- auxiliary labels (e.g., shake well) are affixed in addition to the
label when necessary.
5.2.3 ...ensures the removal of outdated, mislabelled or deteriorated
drugs and those recalled from regular stock, for storage in a separate
area for appropriate disposal. Drugs returned by clients should also
be stored for appropriate disposal as per the employer's procedures.
The nurse/pharmacist ensures that:
- expired and recalled drugs are not dispensed;
- drugs returned by clients are not dispensed to other clients;
- drugs prescribed and dispensed for a specific client are not dispensed
to another client;
- drug recall policies and procedures are in place and enacted if necessary;
- dispensed drugs will not expire prior to the client completing the
course of therapy;
- drugs are provided in the most appropriate package to ensure stability;
and
- adequate instructions on proper storage are provided.
5.2.4 ...ensures that expired, recalled, returned or contaminated
narcotics are segregated from other narcotics and controlled drugs and
stored in the lockup until authorization is received from the Office
of Controlled Substances in accordance with employer's policies and procedures
to destroy these locally or to ship them to an authorized facility for
disposal.
5.3 Delegation of Distribution Activities
5.3.1 ...in satellite facilities when full-time nursing services
are unavailable, the nurse/pharmacist assigns or delegates the distribution
activities to authorized personnel within their scope of duties and abilities.
5.3.2 ...where appropriate the pharmacist can delegate distribution
activities to authorized personnel.
5.4 Extemporaneous Preparations
The pharmacist prepares extemporaneous preparations within her/his scope
of practice.
The pharmacist:
5.4.1 ...documents calculations and other information pertinent
to the preparation on the prescription or in the client's record.
5.5 Clients' Unused Drugs
The nurse/pharmacist accepts the return of unused drugs for safe and
appropriate disposal as per employer's procedures. These drugs must not
be dispensed to other clients.
5.6 Record Keeping
The nurse/pharmacist shall ensure that each time a prescription is filled,
the transaction is recorded, either on the original prescription or on
a suitable prescription record (e.g., medication profile). Generally,
in a nursing station this transaction is recorded in the client's chart.
5.7 Time Frame for Valid Prescriptions
The nurse/pharmacist shall not fill a new prescription or refill a prescription
after 12 months from the date that the prescription was written.
Standard #6: Pharmacy Operations
The nurse/pharmacist applies knowledge, principles and skills
of management as they pertain to the site of pharmacy practice, with
the goal of optimizing patient care and interprofessional relations.
6.1 Management Activities
The nurse/pharmacist in collaboration with management, ensures that
pharmacy operations are designed to protect the public and the people
working on the premises.
The nurse/pharmacist or the nurse/pharmacist in collaboration
with management:
6.1.1 ...maintains the pharmacy in a professional manner which
inspires client confidence in the pharmacy services that can be provided.
6.1.2 ...ensures that adequate space, facilities, equipment and
supplies are available to fulfil the needs of the professional, educational,
and administrative functions of the pharmacy services, to ensure client
safety through proper storage, preparation, dispensing, distribution,
and disposal of drugs. This includes ensuring that the pharmacy/medication
room:
- is weatherproof, dry, free of pests, ventilated, heated, lighted,
in a state of good repair and sanitation and otherwise hygienic;
- has a double-locked cupboard for the storage of narcotic and controlled
drugs in accordance with the relevant federal legislation;
- has surfaces that are readily cleanable and that are kept sanitary;
- is a non-smoking room;
- has a sanitary sink with potable hot and cold running water. The
sink must not be used for disposal of biological wastes or cleaning
containers for biological waste;
- has a working refrigerator that is exclusively for keeping drugs
and vaccines;
- has adequate equipment (including a computer or typewriter), materials
and supplies (e.g., vials, labels, auxiliary labels, counting trays,
distilled water, etc.) sufficient to perform pharmacy services; and
- has a Narcotic and Controlled Drug Register (record system).
6.1.3 ...ensures that procedures for the handling and evaluation
of medication errors and incidents are developed and followed.
6.1.4 ...ensures that adequate and appropriate inventory is available.
6.1.5 ...is aware of the financial management of the inventory.
6.2 Staffing
The nurse/pharmacist or the nurse/pharmacist in collaboration with management
ensures that adequate staffing is maintained with respect to workload
that allows pharmacy to be practiced in accordance with these Standards
of Practice.
6.2.1 ...in collaboration with management ensures that staff, providing
pharmacy services, is trained, supervised and delegated responsibility
using appropriate division of functions that recognize that the nurse/pharmacist
is responsible for all activities relating to pharmacy practice.
6.3 In-Service Education
The nurse/pharmacist in collaboration with management will arrange
for the provision of in-service education to foster and maintain the
competence of staff who provide pharmacy services.
6.4 Policies and Procedures
The employer shall establish current written policies and procedures
for staff, providing pharmacy services, with clear direction on the scope
and limitations of their functions and responsibilities.
6.4.1 ...written policies and procedures for pharmacy services
shall guide all personnel in the performance of their duties.
6.4.2 ...a comprehensive policy and procedures manual will contain
information relating to the administrative aspects of pharmacy services
as well as the medication-related activities.
6.4.3 ...all pharmacy staff will be familiar with the manual.
It is important for new staff orientation and crucial to staff development
and continued competence.
6.4.4 ...these policies and procedures shall be reviewed annually,
revised if necessary and dated to indicate the time of the last review
and/or revision.
6.5 Access to Professional Consultation
The employer shall ensure that in facilities without a pharmacist,
access to a pharmacist and a physician is available 24 hours per day
for advice/consultation.
Glossary
Administer
to give, to inject or to apply medication as directed to a client.
In some situations, medication may need to be prepared prior to
administration--e.g., some injectables require reconstitution prior to
administration.
Agent
one who acts on behalf of a client.
Authorized Personnel
for the purposes of these standards, nurses or pharmacists or individuals
authorized by them to have access to the
pharmacy/medication room.
Caregiver
a person who provides care to a client; may be, but is not exclusive
to, a parent(s), guardian, homecare worker, etc.
Client
the individual who receives care at one of the health facilities and
requires pharmacy services (for the purposes of these standards).
Competence
the condition or quality of being competent; reflects the combined knowledge,
abilities, skills, attitudes and judgment, required for the safe distribution
of drugs.
Delegation
refers to the transfer of authority to a person who is not otherwise
authorized to perform a procedure within a controlled act. The responsibility
lies with the person who is transferring the authority.
Dispense
to prepare and to give out drugs in accordance with orders issued by
a practitioner for a specific client. Dispensing includes all of the
steps which must take place from the receipt of the prescription/order
through to the delivery of the medication to the client.
Distribution
the act of providing drugs to the client in a controlled manner.
Drug
for the purposes of this document, a drug is any substance defined as
such in the federal legislation and includes any drug product.
Employer
person or organization that uses and pays for the services of workers.
Extemporaneous Products
products that require compounding in a pharmacy/medication room in compounds
accordance with the orders of a prescriber and which must not duplicate
the formulations of commercially manufactured drug products.
Community Centre
a field unit staffed by one or more community health nurses and support
health personnel to carry out disease prevention and health promotion
activities in the community. Services for primary/urgent care are provided
by physicians residing in the area.
Health Facilities
FNIHB sites where varying levels of health care are provided and include
nursing stations, health centers and health stations.
Health Station
a field unit in a small building or trailer in an isolated or semi-isolated
community. A Health Station houses field unit staff consisting of community
health nurse(s) and other health care support staff to carry out disease
prevention and health promotion activities in the community. A Health
Station may include primary care services for urgent health needs of
the community which is available on weekdays only and not on a 24-hour
basis. Physician services and dental services are provided on a visiting
basis.
Management
person(s) with effective control or authority, directing the affairs
of the organization; different levels of management exist with different
degrees of authority, ie, at nursing station level, zone level or regional
office.
Mandatory Package
relevant patient information which has been approved by Health Canada.
Insert which must accompany a drug when it is dispensed to a patient
to ensure that the drug is used correctly and safely. (This is not
the same as the product monograph or facility-generated leaflet.)
Medical Device
any article, instrument or apparatus for use in the diagnosis, treatment,
mitigation or prevention of disease, disorder or abnormal physical
state or its symptoms in humans.
Medication Error
an event which involves the actual incorrect administration of a drug
or omission of a prescribed drug to a client.
Nonprescription
any drug or product not requiring a prescription for sale in Canada,
as determined by the Therapeutic Products Program. (Note: provincial
laws can be more restrictive and require a prescription for these drugs.)
Nurse
refers to a registered nurse.
Nursing Station/ Treatment Health Facility
a health facility staffed by two or more community health nurses and
other support and primary health care staff organized to carry out
primary health care services including management of common health
problems/conditions, urgent/emergent care across the lifespan. Services
of disease prevention and promotion are also provided. Access for urgent/emergent
health needs is available on a 24-hour basis, except in those areas
designated and staffed as "day treatment only". Physician consults
are available on a 24-hour call basis with scheduled visits to the
communities. Many of these facilities are located in isolated/semi-isolated
and remote communities.
Outdated (Expired)
not used within expiration date. Includes those drugs that are within
a date, but when issued are likely to be consumed beyond their expiry
date.
Over-the- Counter Drug
a drug that can be purchased without a prescription. (Also known as an
OTC or nonprescription drug.) See also nonprescription drug.
Pharmacy Support
anyone who is not a nurse with responsibility to provide pharmacy staff
services or who is not licenced to practice pharmacy and who assists
in the provision of pharmacy services under the supervision of a nurse/
pharmacist.
Prescribe
to recommend or order a drug, remedy or treatment. Drugs must be prescribed
by an authorized practitioner for a specific client with specific instructions
and for a stated amount.
Practitioner
a person who is registered and entitled under the laws of a province
to practice in that province the profession of medicine, dentistry
or veterinary medicine and includes other persons so identified. For
the purposes of this document, practitioner also refers to a FNIHB
nurse with an expanded scope of practice.
Prescriber
a person with authority to prescribe drugs. In the context of this document,
it includes licenced physicians and dentists and nurses with expanded
scope of practice.
Prescription
an order from a practitioner or an FNIHB-employed nurse with an expanded
scope of practice, authorizing the dispensing of a stated amount of
drug to a person named in the authorization. In FNIHB, nurses with
an expanded scope of practice can prescribe drugs in accordance with
the guidelines in the Nurses Drug Classification System.
Prescription Drugs
those drugs listed in Schedule F of the Food and Drug Regulations and
in Schedule I of the provincial acts. They require a prescription from
an authorized practitioner.
Standards of Practice
a requirement of professionalism in pharmacy practice respecting competency,
ethical conduct and the application of pharmaceutical knowledge and
skills.
Transfer of Dispensing
in the context of this document, it is the transfer of authority to dispense
drugs to a person who is not otherwise authorized to perform this task
or procedure within a controlled act. The responsibility in this case
lies with the person to whom the authority has been transferred (e.g.,
in Saskatchewan, dispensing has been transferred to some nurses.)
Appendix I
List of Suggested Drug Information Resources
Note: The following suggested list includes but is not limited to
the resources listed.
Clinical Guidelines for First Nations and Inuit Health Branch
Personnel
- Nurses' Drug Classification System;
- Regional Narcotic and Controlled Drugs Policy;
- Selected regulations to the Controlled Drugs and Substances Act (Canada);
and
- Selected regulations to the Food and Drugs Act (Canada).
Texts, including examples:
- Compendium of Pharmaceuticals and Specialties (current edition)
Welbanks L (ed). Compendium of pharmaceuticals and specialties.
36th ed. Ottawa: Canadian Pharmacists Association, 2001.
- Therapeutics text such as:
- Gray J (ed). Therapeutic Choices. 3rd ed.
Ottawa: Canadian Pharmacists Association, 2000.
- Books on pediatric dosages such as:
- Isaacs E (ed). Pediatric drug dosage handbook. 8th ed.
Winnipeg: Department of Pharmaceutical Services, Health Sciences
Centre. 1999. (Note: new publication edited by Take Tomo is scheduled
for Oct-Nov, 2000.)
- Dipchand A (ed). The HSC handbook of pediatrics. 9th ed.
Toronto: the Hospital for Sick Children, 1997.
- Pagliaro LA, Pagliaro AM (eds). Problems in pediatric drug
therapy. 3rd ed. Hamilton IL: Drug Intelligence
Publications, Inc, 1995.
- Books on drug interactions such as:
- Hansten PD et al (eds). Hansten and Horn's Drug Interactions
Analysis and Management. Vancouver, WA: Applied Therapeutics,
Inc. 1998.
- Tatro, DS (ed). Drug Interaction Facts. St. Louis, MO:
First Data Bank, 1999.
- Lilac pages in: Welbanks L (ed). Compendium of pharmaceuticals
and specialties. 35th ed. Ottawa: Canadian Pharmacists
Association, 2000.
- Book/resource on herbal remedies, including interactions
with drugs such as:
- Chandler F (ed). Herbs: Everyday Reference for Health Professionals.
Ottawa: Canadian Pharmacists Association and Canadian Medical
Association, 2000.
Access to a drug information centre or pharmacist with drug information
resources.
Appendix II
Mandatory Package Inserts
In a July 21, 1999 communication, Health Canada has advised that Patient
Package Inserts have been made mandatory as part of the marketing authorizations,
Notice of Compliance (NOC) and/or Drug Identification Number for the
drugs listed below. The patient information material supplied by the
manufacturer should be dispensed with:
- Prescription Drugs:
- Drugs delivered with the assistance of a device (e.g., inhalers,
transdermal patches)
- Isotretinoin and other oral tretinoids, except those used in
oncology
- Methotrexate for rheumatoid arthritis
- Nonsteroidal anti-inflammatory drugs (NSAIDS)
- Oral contraceptives
- Ticlopidine
- Biologicals--all drugs intended for self-administration including:
- Erythropoietin
- Gonadotropins
- Human Growth Hormone
- Insulins
- Interferons
- Wound Healing Factors
- All drugs where the Product Monograph or Prescribing Information
indicates
that a patient information document is available.
Appendix III
OTC Medication List for
Non-Treatment Health Facilities
Analgesics/Antipyretics
Acetaminophen Drops(Tylenol 80 mg/ml) 24 ml
Acetaminophen Elixir(Tylenol 32 mg/ml) 100 ml
Acetaminophen Ped. Tablets (80mg or 160 mg) 24 or 20 tab/btl
Acetaminophen (325 mg) (Immunization Program Only) 12 tab/btl
Expectorant Cough Syrup*
Guaifenesin (both Alcohol and Sugar-free) [e.g., Balminil Expectorant
Sucrose-free, Koffex Expectorant Syrup(sucrose-free)]
*Note: These cough preparations will not be included on the next List.
Steps should be taken to phase them out.
Vitamins
Infant Multivitamin (e.g., Infantol, Tri-vi-sol)
Vitamin D (e.g., D Vi Sol 400IU/ml)
Prenatal Vitamins ( e.g., Orifer F, Materna)
Topical
Bacitracin-containing Ointment (e.g., Bacitin, Baciguent, Polysporin)
Calamine Lotion
Crotamiton Cream (Eurax)
Permethrin Dermal Cream 5% (Nix Dermal Cream)
Permethrin Rinse Creme (Nix Creme Rinse)
Pyrethrins with Piperonyl Butoxide Shampoo (R&C Shampoo)
Zinc Oxide Cream (e.g., Zincofax)
Lubricant, water-based (e.g., Muko, K-Y Jelly)
Appendix III-a
Medications for Management of Anaphylaxis
Epinephrine Injection (1:1000 amp)
Benadryl® Children's Liquid 1.25 mg/ml
Diphenhydramine Injection 50 mg/ml
Note: These medications must be available in the Non-Treatment Health
Facilities for the management of anaphylaxis which may occur during immunization.
Dosages are outlined in The 5th Edition Canadian Immunization Guide.
These medications are not intended to be issued to clients for home use.
Note: Supplies, such as hydrogen peroxide, utilized by staff in the
health care facility are not identified in this policy. Supplies should
be selected and stocked in accordance with management discretion and
facility need. These items are not to be sent home with the client.
Appendix IV
Suggested List of Narcotic/Controlled Drug Issues to be
Addressed in a Policies and Procedures Manual
- Definitions
- Responsibilities of FNIHB personnel
- Accounting procedures
- requisitioning/ordering;
- distribution;
- accounting and records; and
- receipts,
- issues,
- charting,
- drug counts, and
- counts discrepancy.
- change of personnel.
- Security
- physical requirements;
- keys/combinations;
- during temporary closure/evacuation; and
- theft/loss.
- Breakage
- Disposal
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