standards of practice: drug adminstration · (e.g. influenza, tetanus, diphtheria, pneumococcal,...

Nova Scotia College of Pharmacists

Standards of Practice

Drug Administration

September 2017

Standards of Practice Drug Administration Acknowledgements

Nova Scotia College of Pharmacists Page: i September 2017/Amended February 2019

Acknowledgements This Standards of Practice document has been developed by the Nova Scotia College of Pharmacists with the assistance and guidance of many individuals and organizations. The College acknowledges and thanks the contributions of the following:

Standards of Practice Committee, Nova Scotia College of Pharmacists

Craig Connolly, Chair Mary Abriel-Sangster Carol-Ann Chaddock Harriet Davies Julia Green-Clements Dr. Jennifer Isenor Sandeep Sodhi Adam Somers Diane Harpell Alicia Spence Jacqueline Gray

Pharmacy Regulatory Authorities

Alberta College of Pharmacists College of Pharmacists of British Columbia New Brunswick Pharmaceutical Society

These regulatory authorities shared their Standards of Practice and experience regarding drug administration to assist with the development of the Nova Scotia Standards of Practice and to support inter-provincial consistency.

External Review and Contributors

Canadian Medical Protective Association College of Physicians and Surgeons of Nova Scotia College of Registered Nurses of Nova Scotia Dalhousie University College of Pharmacy (Dr. S. Bowles, Dr. K. Slayter) Doctors Nova Scotia Nova Scotia Department of Health and Wellness Public Health Services, Nova Scotia Department of Health and Wellness Pharmacy Association of Nova Scotia

Standards of Practice Drug Administration Table of Contents

Nova Scotia College of Pharmacists Page: ii September 2017/Amended February 2019

Table of Contents 1 Introduction ................................................................................................. 1

2 Definitions ................................................................................................... 2

3 Standards of Practice....................................................................................... 3

Appendix A – Reference Documents ........................................................................ 16

Appendix B – NSCP Drug Administration by Injection Permit Requirements .......................... 17

Appendix C – First Aid and CPR Certification Requirements ............................................ 18

Appendix D – Patient Consent and Disclosure Requirements ............................................ 19

Appendix E – Reciprocal Notification Form ................................................................ 23

Appendix F – Drug Administration Notification Form ..................................................... 24

Standards of Practice Drug Administration Introduction

Nova Scotia College of Pharmacists Page: 1 September 2017/Amended February 2019

1 INTRODUCTION Under the authority of the Pharmacist Extended Practice Regulations, the Standards of Practice: Drug Administration establish the clear accountabilities and responsibilities of pharmacists regarding the administration of drugs. Pharmacists will undertake the administration of drugs in accordance with these Standards of Practice as well as public health guidelines and existing legislation, regulations, the Code of Ethics, other standards of practice and policy directives relevant to pharmacy practice in Nova Scotia.

The Regulations enable pharmacists in the province to more fully apply their skills and competencies within the health care system as experts in medication therapy management. They enable pharmacists to more effectively fulfill the intent and purpose of the Pharmacy Act, which states that pharmacists are responsible for the provision of optimal patient care.

One of the expanded activities authorized by the Regulations allows pharmacists to provide services associated with drug administration. For example, pharmacists with the applicable NSCP Drug Administration by Injection Permit have the authority to administer drugs, including vaccines, by injection.

The authority to provide drug administration services provides pharmacists with the opportunity to further support the health and wellbeing of Nova Scotians and to address some of the challenges of health care delivery in the province. Furthermore, the authority to administer drugs by injection allows pharmacists to play an important role in helping to combat vaccine-preventable diseases in Nova Scotia. Their knowledge and expertise to identify patients who need vaccinations, their experience in direct patient care and handling and safeguarding medications and their ready accessibility because of their locations in patients’ neighbourhoods, make them ideally suited for this role. This, coupled with the persuasiveness of a trusted healthcare professional, places the pharmacist in a position to have a major impact on vaccine preventable illness and death.

The Standards of Practice document includes the following:

Definitions – glossary of terms referenced in the standards; Standards of Practice – requirements and expectations for drug administration

by pharmacists; and Appendices – supporting tools and documents.

Original approval: May 2013 Revisions: June 2014, October 2014, May 2015, November 2015, Sept 2017

Standards of Practice Drug Administration Definitions

Nova Scotia College of Pharmacists Page: 2 September 2017/Amended February 2019

2 DEFINITIONS Definitions for terms represented in the Standards of Practice: Drug Administration are provided in the following table.

Term Definition

NSCP Drug Administration by Injection Permit

The Permit from the NSCP indicating that the pharmacist has met the drug administration by injection requirements specified by Council and has applied for and received the Permit.

Patient

For the purpose of these Standards, each reference to the patient means patient or their agent.

Procedure Gloves

Disposable gloves of latex, vinyl or nitrile material that are used to provide protection for the wearer when performing medical procedures or examinations. Procedure gloves need not be sterile.

Provincial DIS

An interoperable system that enables authorized health care providers to access, manage, share and safeguard patient’s medication histories. It is a key component of the provincial electronic health record (EHR).

Regulated Health Care Professional

An individual who is licensed to provide specific health care services to patients, including but not limited to, dentists, midwives, nurses, optometrists, pharmacists, and physicians.

Routine Practices

The activities that are carried out to help reduce the risk of being exposed to blood, body fluids or non-intact (broken) skin of other people. Proper hand hygiene, use of face protection (i.e. masks or shields) and gloves, safe sharps handling and environmental cleaning are examples of routine practices.

Standards of Practice Drug Administration

Nova Scotia College of Pharmacists Page: 3 September 2017

3 STANDARDS OF PRACTICE The following Standards of Practice represent overall requirements for the administration of a drug to a patient.

3.1 FOCUS ON HEALTH CARE NEEDS OF PATIENT

3.1.1 A pharmacist shall undertake the administration of a drug to support the health care needs and health outcomes of the patient.

3.1.2 A pharmacist may undertake the administration of a drug to a patient orally, sublingually, buccally, via inhalation or topically to the skin, eye, ear or nose (intranasally) where they have current certification in First Aid and Cardiopulmonary Resuscitation (CPR) (refer to Appendix C for specific information regarding First Aid and CPR certification).

3.1.3 Drug administration by intramuscular (IM) or subcutaneous (SC) injection may be undertaken where:

the pharmacist has been granted a NSCP Drug Administration by Injection Permit by the Registrar (refer to Section 3.3.2 and Appendix B for further details regarding the NSCP Permit);

the patient is five years of age or older; and the injection is:

for a drug listed in Schedule I pursuant to the Drug Schedules Regulations of the Nova Scotia Pharmacy Act that is:

being used in an emergency situation to address an immediate risk to the patient’s health/life (e.g. epinephrine, etc.) and to provide sufficient time for the patient to see their primary health care provider or other health care professional;

for the prevention of Hepatitis A, Hepatitis B, Varicella, Herpes Zoster, Human Papillomavirus (HPV) or Typhoid; or

prescribed and administered in accordance with providing comprehensive travel health services as described in Appendix E-Prescribing Preventative Medicines of Standards of Practice:Prescribing Drugs.

The Regulations require a

pharmacist to comply with the

Standards of Practice adopted and from time to

time amended by the Nova

Scotia College of Pharmacists.



for a drug listed in Schedule II pursuant to the Drug Schedules Regulations of the Nova Scotia Pharmacy Act including, but not limited to, vaccines in the provincial immunization program (e.g. influenza, tetanus, diphtheria, pneumococcal, etc.).

3.2 UNDERSTAND AND TAKE ACCOUNTABILITY

3.2.1 A pharmacist is accountable for their decision to administer a drug, including actions and omissions, and for the associated benefits and risks to the patient. They cannot delegate this accountability to another individual.

3.2.2 A pharmacist shall recognize and accept responsibility for the impact of their drug administration activities on the overall costs and sustainability of the health care system.

3.2.3 A pharmacist shall recognize that they undertake the administration of a drug in consideration of the overall patient care plan and process. With respect to drug administration, they are responsible for the provision of optimal patient care, monitoring drug therapy and ensuring the pharmaceutical and therapeutic appropriateness of drug therapy.

3.3 USE KNOWLEDGE AND UNDERSTANDING

3.3.1 When undertaking drug administration activities, a pharmacist shall comply with the Standards of Practice: Drug Administration as well as public health guidelines and existing legislation, regulations, the Code of Ethics, other standards of practice and policy directives relevant to the practice of pharmacy in Nova Scotia (refer to Appendix A for a list of reference documents).

3.3.2 A pharmacist may directly administer a drug by injection to a patient if granted a NSCP Drug Administration by Injection Permit by the Registrar. The Permit is provided by the Registrar pursuant to the Regulations when the pharmacist:

has completed an immunization and injection administration education and training program approved by Council;

meets the current requirements for certification in First Aid and CPR;

has reviewed the NSCP Standards of Practice: Drug Administration, and

provides a Permit application to the Registrar and any associated fee specified by Council.



Refer to Appendix B for further details regarding the NSCP Drug Administration by Injection Permit requirements, and Appendix C for specific information regarding First Aid and CPR certification requirements.

Refer to the NSCP Clarification of Requirements for Injection Permit Policy for information on requirements in certain circumstances including: pharmacists with injection authorization from other Canadian jurisdictions; pharmacists whose Permit has lapsed; or pharmacists whose immunization and injection administration education and training was obtained more than 12 months prior to applying for the Permit.

3.3.3 To annually renew the NSCP Drug Administration by Injection Permit a pharmacist shall:

have completed an immunization and injection administration education and training program approved by Council in the past;

maintain current certification in First Aid and CPR; review provincial immunization schedules; review pertinent information in National Advisory

Committee on Immunization (NACI) statements and Immunize Canada newsletters released since the last annual renewal;

review the NSCP Standards of Practice: Drug Administration;

renew the Permit at the time of annual online license renewal, and

declare that they have completed a sufficient number of injections in the preceding three years to maintain their competency to administer drugs by injection.

3.3.4 To renew the NSCP Drug Administration by Injection Permit when the Permit renewal has not been maintained, i.e., the Permit has lapsed, or when the pharmacist has not, based on their professional judgement, completed a sufficient number of injections to maintain their competency, the pharmacist shall:

have completed an immunization and injection administration education and training program approved by Council in the past;

maintain current certification in First Aid and CPR; complete a refresher version of an immunization and

injection education and training program approved by Council (e.g. Dalhousie IIARP);

review provincial immunization schedules;



review pertinent information in National Advisory Committee on Immunization (NACI) statements and Immunize Canada newsletters released since the initial Permit was granted;

review the NSCP Standards of Practice: Drug Administration;

review Immunization Competencies for Health Professionals (Public Health Agency of Canada) and complete the associated Immunization Competencies Leveling Tool;

provide the Permit Renewal application to the Registrar.

3.3.5 A pharmacist shall have sufficient knowledge of the specific drug, the condition being treated and administration process when undertaking the administration of a drug and shall only administer a drug in accordance with:

their scope of practice, and their knowledge, skills, competencies and experience.

It is the responsibility of the pharmacist to assess whether or not the specific circumstances of each potential instance of drug administration are within their scope of practice, knowledge, skills, competencies and experience.

3.3.6 A pharmacist shall be satisfied that the intended use of the drug to be administered reflects an indication approved by Health Canada. If they are dealing with a drug that is being used for an indication not approved by Health Canada, the pharmacist must be satisfied that it is:

widely accepted in Canada and supported by extensive medical literature demonstrating safety and efficacy; or

consistent with a research protocol in which the patient is enrolled.

3.3.7 A pharmacist shall be satisfied that the drug to be administered is:

being used in accordance with the approved patient age range for the drug,

being provided at a dose and route of administration which are suitable for the patient, and

appropriate for the patient in the specific circumstances.



3.4 COLLABORATE WITH OTHER HEALTH CARE PROFESSIONALS

3.4.1 When administering a drug, a pharmacist shall collaborate and consult with other pharmacists or health care professionals in their pharmacy, the patient’s primary health care provider and other health care professionals if appropriate and in the best interest of the patient.

3.4.2 With regard to the administration of a drug, a pharmacist shall recommend that the patient seek the care of another health care professional, as appropriate to the situation.

3.5 MAINTAIN PROFESSIONAL INDEPENDENCE

3.5.1 When administering a drug, a pharmacist shall avoid situations that present a conflict of interest that compromises their professional independence, judgment or integrity:

e.g., accepting gifts, inducements or other benefits from a patient, other health care professional, pharmaceutical manufacturer, supplier or other organization/person, or

forming an association with a patient, other health care professional, pharmaceutical manufacturer, supplier or other organization/person.

3.5.2 The decision by a pharmacist to administer a drug shall be based on clinical suitability, cost effectiveness and the patient’s best interest. Decisions to administer a drug based on bias-oriented information or on providing financial advantage to the pharmacist and/or pharmacy without providing benefit to the patient may be regarded as professional misconduct.

3.6 ENABLE INFORMED DECISIONS

3.6.1 The pharmacist shall be satisfied that the patient or the patient’s agent, if applicable, has sufficient information and understanding to make an informed decision regarding consent to the administration of the drug.

3.6.2 A pharmacist shall provide the patient or patient’s agent with information that is understandable and sufficient to allow him/her to make an informed decision to accept or decline the administration of a drug. To support their decision, the pharmacist shall provide the opportunity for the patient or patient’s agent to ask questions and obtain responses about the administration of a drug. The information to be provided shall include the following:

Consent (written or verbal) is to

be obtained each time that a pharmacist

undertakes the administration of

a drug.



name of the drug to be administered, objective of the drug administration (e.g. disease

prevention, treatment, etc.), benefits and risks, including risks of not receiving the

vaccine expected reactions, usual and rare side effects, where applicable, requirement and rationale for a wait

period following administration, post-administration monitoring and follow-up, if

applicable, and cost, where applicable.

3.6.3 A pharmacist shall obtain informed and voluntary consent from the patient or the patient’s agent (i.e. substitute decision maker) in accordance with applicable legislative requirements (refer to Appendix D for Patient Consent Requirements) to administer the drug and, where applicable, to disclose the administration of the drug to other appropriate health care professionals (e.g. primary health care provider) and/or the local public health services office.

3.6.4 When a patient is represented by an agent, a pharmacist shall apply the standards for the relationship with the patient to the relationship with the agent, as appropriate.

3.7 PROVIDE SAFE AND APPROPRIATE DRUG ADMINISTRATION

3.7.1 A pharmacist shall provide an environment for drug administration which is clean, safe and comfortable for the patient. Generally, drugs shall be administered in a separate room to provide privacy for the patient unless it is not practical (e.g. mass immunization to address public health threat/risk, emergency situation, etc.) or the patient requests otherwise.

3.7.2 A pharmacist shall follow routine and established precautions for infection control when administering a drug, including but not limited to:

washing hands before and after caring for the patient and, if applicable, after removing gloves;

adhering to Routine Practices (for details on Routine Practices, refer to Health Canada Infection Control Guidelines);

wearing clean procedure gloves for situations that may involve the following:

contact with blood, body fluids, secretions and excretions,

Note that gloves are not required for routine drug

administration activities in

which contact is limited to a

patient’s intact skin.



contact with surfaces or objects contaminated by blood, body fluids, secretions and excretions,

contact with mucous membranes, contact with draining wounds or non-intact skin,

and/or when the pharmacist has open skin lesions on

their hands.

3.7.3 A pharmacist shall ensure that the drug to be administered to a patient is:

stable and not expired; stored appropriately at all times to maintain its integrity

including, where applicable, adherence to the National Vaccine Storage and Handling Guidelines for Immunization Providers (refer to Appendix A)

stored and labeled appropriately following reconstitution or mixing, if applicable.

3.7.4 When a pharmacist is providing drugs by injection in a pharmacy, the pharmacist manager shall establish and maintain drug administration policies and procedures and a pharmacist shall apply these policies and procedures in their pharmacy or practice setting. The drug administration procedures shall include requirements and processes for the following at a minimum:

drug storage, drug handling, drug administration, post administration monitoring and treatment options, emergency protocols and treatments, precautions for patients with latex allergies, handling/disposal of medical sharps and biohazardous

waste, universal precautions for injections, notification of other health care professionals (including

sample forms), and documentation of drug administration.

The pharmacy manager shall review and, if required, update the drug administration policies and procedures annually.



3.7.5 A pharmacist shall provide for ready access in their pharmacy or practice setting to drugs, health care products, aids, devices, equipment and supplies to treat emergencies or adverse reactions associated with the administration of drugs, including at a minimum:

copy of anaphylaxis procedures and doses recommended of epinephrine and diphenhydramine for weight and age. Refer to the Canadian Immunization Guide for information regarding the treatment of adverse events following immunization;

4 x 1cc syringes with attached needles, 1 x 3cc syringes and 5 needles (25-G 5/8”, 1” and 1½”) and alcohol swabs;

2 vials of epinephrine 1:1000, or alternatively, two doses each of both the adult and junior epinephrine autoinjectors. Note: A minimum of two doses of epinephrine must be available because the symptoms of anaphylactic reaction can reoccur after the initial reaction (biphasic anaphylaxis);

1 vial of diphenhydramine, 25mg tablets and oral liquid; and

resuscitator bag/equipment* to maintain adult and child airways.

Note: The vaccine provider should check the contents of the emergency kit regularly (before each immunization session), in particular, drug vials, ampoules or autoinjectors and their expiration dates.

*Optional for use in pharmacies with pharmacists who have certification in CPR Level HCP or equivalent.

3.7.6 A pharmacist shall be prepared to treat emergencies or adverse reactions associated with the administration of drugs, including at a minimum:

providing basic first aid, use of adrenalin/epinephrine and diphenhydramine by

injection if necessary, performing CPR, managing sensitivity/anaphylactic reactions, and addressing needle stick injuries.

3.7.7 A pharmacist shall complete the following in order to administer a drug to a patient via an oral, sublingual, buccal, inhalation or topical (i.e. to the skin, eye, ear or nose) route of administration:

assemble appropriate equipment and supplies, if applicable;

Note: A minimum of two doses of

epinephrine must be available because the symptoms of anaphylactic reaction can

reoccur after the initial reaction

(biphasic anaphylaxis).



confirm that the drug product, dosage and route of administration is appropriate for the patient;

confirm that the drug is being administered in accordance with accepted and appropriate administration techniques for that drug;

check the expiry date of the drug; immediately prior to administration, state the patient’s

name and drug name to the patient to confirm that the appropriate drug is being administered to the appropriate individual;

use aseptic technique to administer the drug; dispose of devices, equipment, any remaining drug or

other waste in a safe and appropriate manner; provide their name and contact information to the

patient; document drug administration details in the patient’s

record (refer to Standard 3.10 for specific documentation requirements); and

where appropriate, communicate drug administration details to other health care professional(s). Refer to Standard 3.9.2 for specific details regarding communication to other health care professionals.

3.7.8 A pharmacist shall complete the following in order to administer a drug by injection to a patient:

assemble appropriate equipment and supplies (e.g. syringe, needle, etc.);

confirm that the drug product, dosage and route of administration is appropriate for the patient;

confirm that the drug is being administered in accordance with accepted and appropriate administration techniques for that drug;

check the expiry date of the drug; immediately prior to injecting the drug, state the

patient’s name and drug name to the patient to confirm that the appropriate drug is being administered to the appropriate individual;

assess, select and landmark the injection site; use aseptic technique to prepare and inject the drug; apply dressings, as required; monitor the post administration response to the injection

and manage any emergency or adverse reactions; dispose of devices, equipment, any remaining drug or

other waste in a safe and appropriate manner; provide their name and contact information to the

patient;



document drug administration details in the patient’s record (refer to Standard 3.10 for specific documentation requirements); and

communicate drug injection details to other appropriate health care professional(s) as appropriate. Refer to Standard 3.9.2 for specific details regarding communication to other health care professionals.

3.8 COMPLETE FOLLOW-UP

3.8.1 Where appropriate (e.g. emergency situation, adverse reaction occurred, recurring treatment, etc.), a pharmacist shall establish a post drug administration follow-up plan, which specifies the therapeutic goal(s) to be monitored. For each goal, the follow-up plan includes the following (as applicable):

description of the therapeutic goal, follow-up actions to be undertaken (e.g. patient call

back), date for follow-up, individual responsible for follow-up, and follow-up results and date (once completed), including

documentation of any subsequent follow-up requirements.

Refer to Standard 3.9.2 for specific details regarding communication of the follow-up plan and results to other health care professionals.

3.8.2 A pharmacist shall undertake any applicable follow-up actions in compliance with the established drug administration follow-up plan. If required, the pharmacist may delegate the follow-up activities to another pharmacist in their pharmacy or other regulated health care professional.

As required by the Public Health Agency of Canada, pharmacists shall report all major and moderate adverse events that occur following vaccine administration to local Public Health Services. The Nova Scotia Immunization Manual, referenced in Appendix A, includes the Adverse Event Following Immunization (AEFI) Guidelines and reporting form. Pharmacists shall report in accordance with these Guidelines.



3.9 COMMUNICATE EFFECTIVELY

3.9.1 The pharmacist shall communicate where appropriate directly with the patient or their agent regarding the drug administration and any follow-up plan or notification to other health care professionals.

3.9.2 In support of continuity of patient care and collaborative care, the pharmacist shall communicate the drug administration details to the patient’s primary care provider in every instance when a drug has been administered by injection and when appropriate in instances when a drug has been administered by a non-injectable route.

The communication shall include, but not be limited to, details regarding the drug administered, any emergency / adverse reaction and associated treatment, any follow-up plan / responsibilities and any applicable subsequent follow-up results.

The pharmacist shall communicate the required information to the patient’s primary health care provider and/or other health care professionals within 24 hours or as soon as possible (refer to Appendix F – Drug Administration Notification Form). The influenza vaccine administration record in the DIS meets the requirement for communication to the primary health care provider.

3.9.3 As required by the Government of Nova Scotia, the pharmacist shall complete the Reciprocal Notification Form and submit it to the local Public Health Services office for any publicly funded vaccine other than the influenza vaccine administered to a patient (refer to Appendix E – Reciprocal Notification Form). A copy of this form is also forwarded to the patient’s primary health care provider (along with the Drug Administration Notification Form – see 3.10) and the remaining copy of this triplicate form is retained by the pharmacist.

3.9.4 The pharmacist shall conduct drug administration related communications (e.g. patient counselling, follow-up or the exchange of personal/sensitive information), with a patient or other health care professionals in a manner that respects the patient’s wishes and confidentiality and in accordance with applicable privacy and pharmacy practice legislation.

3.9.5 The pharmacist shall notify the patient as soon as possible if any information related to the drug administration is compromised.

At the time of publication of

these Standards, the only vaccine

that will be supplied to

pharmacies by Public Health is

the influenza vaccine, which

does NOT require the

submission of the Reciprocal

Notification Form.



3.10 COMPLETE DOCUMENTATION

3.10.1 The pharmacist shall record the drug administration details in the patient record including:

Patient name, address and contact information, Acknowledgement of information and voluntary consent

in accordance with applicable legislative requirements (refer to Appendix D for Patient Consent Requirements),

Drug, dose and lot number, Route and site of administration, Site of administration (where applicable), Date and time of administration, Patient condition before and response during and

immediately following administration of drug. Where applicable, patient response following the 15-30 minute post-administration monitoring period,

If applicable, details regarding action taken to address emergency or adverse reaction,

Name of pharmacist who administered the drug, If applicable, date and method of notifying other health

care professional(s), For vaccines other than the influenza vaccine (as per

Standard 3.9.3), notation that the Reciprocal Notification Form (refer to Appendix E) has been completed and copies forwarded to both the local public health services office and patient’s primary health care provider, and

If applicable, a follow-up plan and/or additional information to enable subsequent monitoring of the patient shall be completed. (Refer to section 3.8 for further details on patient follow-up.)

3.10.2 The pharmacist shall create and maintain documentation regarding the administration of a drug that is:

accurate, concise, legible, complete and organized. Any abbreviations used shall be clear and well-known to all health care professionals, and not in the Error-Prone Abbreviation List published by the Institute for Safe Medication Practices. (Refer to Appendix A – Reference Documents),

completed in a timely manner concurrent with the process,

if the drug is a vaccine, consistent with the Abbreviations for (vaccine) Products Available in Canada, included in the appendix of Canadian Immunization Guide,

recorded in a manner that facilitates use, sharing and ready retrieval by authorized individuals,



recorded using an electronic and/or paper based system. If both are being used, the electronic record shall identify and reference the paper record,

documented so that it cannot be deleted. Any corrections or adjustments are noted, tracked and include the identity of the individual who completed the change,

handled in a manner to protect the integrity of the information, and

retained in accordance with the Registration, Licensing and Professional Accountability Regulations.

Standards of Practice Drug Administration Appendix A – Reference Documents


APPENDIX A – REFERENCE DOCUMENTS Pharmacists shall carry out the administration of drugs in accordance with these Standards of Practice as well as existing legislation, regulations, the Code of Ethics, agreements, other standards of practice and policy directives relevant to pharmacy practice in Nova Scotia and the following references as appropriate:

Canadian Immunization Guide*, Public Health Agency of Canada, www.phac-aspc.gc.ca/publicat/cig-gci/

Nova Scotia Immunization Manual*, 2013, Public Health Services, Nova Scotia Department of Health and Wellness http://novascotia.ca/dhw/cdpc/documents/Immunization-Manual.pdf

National Vaccine Storage and Handling Guidelines for Immunization Providers*, 2007, Public Health Agency of Canada healthycanadians.gc.ca/publications/healthy-living-vie-saine/vaccine-storage-entreposage-vaccins/index-eng.php

Immunization Competencies for Health Professionals, Public Health Agency of Canada www.phac-aspc.gc.ca/im/pdf/ichp-cips-eng.pdf

It’s the Law: Reporting Adverse Events Following Immunization (AEFI), Nova Scotia Public Health Services (includes local Public Health offices listings) http://novascotia.ca/dhw/cdpc/documents/13087_AdverseEventsPoster_En.pdf

Adverse Event Following Immunization form (AEFI), Public Health Agency of Canada www.phac-aspc.gc.ca/im/pdf/raefi-dmcisi-eng.pdf

Communicable Disease, Information for Professionals, NS Public Health Services http://novascotia.ca/dhw/CDPC/info-for-professionals.asp

Infection Prevention and Control Best Practices for Long Term Care, Home and Community Care including Health Care Offices and Ambulatory Clinics June, 2007 www.phac-aspc.gc.ca/amr-ram/ipcbp-pepci/infection-eng.php

Routine Practices and Additional Precautions for Preventing the Transmission of Infection in Health Care, Health Canada (2012) www.ipac-online.com/pdf/2013_PHAC_RPAP-EN.pdf

Hand Hygiene Practices in Healthcare Settings, Public Health Agency of Canada www.phac-aspc.gc.ca/nois-sinp/guide/summary-sommaire/hh-hm-eng.php

Keep Vaccine Safe* http://novascotia.ca/dhw/cdpc/documents/13114_Keep-Vaccine-safe.pdf

Safe Sharps Bring-back Program, Pharmacy Association of Nova Scotia, https://pans.ns.ca/public/programs/safe-sharps

Needlesticks and Sharps Injuries, Canadian Centre for Occupational Health and Safety http://www.ccohs.ca/oshanswers/diseases/needlestick_injuries.html

*See these references for information on the maintenance of cold chain.

http://www.phac-aspc.gc.ca/publicat/cig-gci/

http://novascotia.ca/dhw/cdpc/documents/Immunization-Manual.pdf

http://healthycanadians.gc.ca/publications/healthy-living-vie-saine/vaccine-storage-entreposage-vaccins/index-eng.php

http://healthycanadians.gc.ca/publications/healthy-living-vie-saine/vaccine-storage-entreposage-vaccins/index-eng.php

http://www.phac-aspc.gc.ca/im/pdf/ichp-cips-eng.pdf

http://novascotia.ca/dhw/cdpc/documents/13087_AdverseEventsPoster_En.pdf

http://www.phac-aspc.gc.ca/im/pdf/raefi-dmcisi-eng.pdf

http://novascotia.ca/dhw/CDPC/info-for-professionals.asp

http://www.phac-aspc.gc.ca/amr-ram/ipcbp-pepci/infection-eng.php

http://www.ipac-online.com/pdf/2013_PHAC_RPAP-EN.pdf

http://www.phac-aspc.gc.ca/nois-sinp/guide/summary-sommaire/hh-hm-eng.php

http://novascotia.ca/dhw/cdpc/documents/13114_Keep-Vaccine-safe.pdf

https://pans.ns.ca/public/programs/safe-sharps

http://www.ccohs.ca/oshanswers/diseases/needlestick_injuries.html

Standards of Practice Drug Administration Appendix B – NSCP Drug Administration by Injection Permit Requirements


APPENDIX B – NSCP DRUG ADMINISTRATION BY INJECTION PERMIT REQUIREMENTS A pharmacist shall fulfill specific requirements and submit an application to the NSCP to obtain their NSCP Drug Administration by Injection Permit. They must meet the requirements as specified below in order to initially obtain the Permit1, to annually renew their Permit2 or to renew a Permit that has not been maintained3.

Permit Requirements

Initial Permit1 Annual Permit

Renewal2

Renewal of Permit not Maintained3

No previous

authoriz’n to inject

Current authoriz’n in other Can. jurisdiction

Lapsed authoriz’n in other Can jurisdiction

Immunization and injection education and training program approved by Council (e.g. Dalhousie IIATP)

Current Cardiopulmonary Resuscitation (CPR) certification See Appendix C

Current First Aid certification See Appendix C

Refresher version of an immunization and injection education and training program approved by Council (e.g.Dalhousie IIARP)

Review provincial immunization schedules and pertinent information in NACI statements and Immunize Canada newsletters

Review the NSCP Standards of Practice – Drug Administration

Review the Immunization Competencies for Health Professionals (Public Health Agency of Canada) and complete the associated Immunization Competencies Levelling Tool

Completed application form

Self-declaration of continued competence to administer drugs by injection4

1 Initial Permit – The pharmacist is obtaining the NSCP Drug Administration by Injection Permit for the first time. Note: If an injection has not been given within 1 year of completion of the education and training program, the pharmacist will be required to complete a refresher version of the education and training program. See Clarification of Requirements for Injection Permit Policy. 2 Annual Permit Renewal – The pharmacist has a current NSCP Drug Administration by Injection Permit and is renewing it for the following licensing year (takes place each year at the time of pharmacist’s license renewal). 3 Renewal of a Permit that has not been maintained – Completed by the pharmacist in order to renew their NSCP Drug Administration by Injection Permit in the following circumstances:

their Permit has lapsed, or the pharmacist has not, based on their professional judgment, completed a sufficient number of

injections to sustain their competency to administer drugs by injection.

4 The pharmacist declares, based on their professional judgment, that they have completed a sufficient number of injections in the preceding three years to maintain their competency to administer drugs by injection. Note: Refer to the Clarification of Requirements for Injection Permit Policy for additional information on requirements.

Standards of Practice Drug Administration Appendix C – First Aid and CPR Certification Requirements


APPENDIX C – FIRST AID AND CPR CERTIFICATION REQUIREMENTS A pharmacist shall maintain current certification in First Aid and Cardiopulmonary Resuscitation (CPR) as required qualifications for administering drugs as specified in Standard 3.1.2 in the Standards of Practice: Drug Administration. Similarly, current certification in First Aid and CPR is required for a pharmacist to obtain their NSCP Drug Administration by Injection Permit as specified in Standard 3.3.2 and Appendix B in the Standards of Practice: Drug Administration.

The specific requirements established by Council for First Aid and CPR certification are outlined below. Certification is to be obtained through an organization approvedby Council:

Canadian Red Cross St. John Ambulance Canada Lifesaving Society

Canadian Ski Patrol Heart and Stroke Foundation

FIRST AID

Certification in Emergency First Aid

CARDIOPULMONARY RESUSCITATION (CPR) CERTIFICATION

Minimum Certification Requirements – all of the following skills are required for CPR certification (CPR Level C or equivalent*):

Adult/Child/Baby CPR – one rescuer Adult/Child/Baby choking Automated External Defibrillator (AED) Operator Certification

In addition to fulfilling the minimum requirements, pharmacists are encouraged to obtain the following preferred / non-mandatory additional CPR skills (offered in CPR Level HCP or equivalent*):

Adult/Child/Baby 2-rescuer CPR Rescue breathing Adult/Child/Baby Bag-Valve-Masks (BVMs)

Recertification Requirements:

Recertification is to be through an approved provider of First Aid and CPR certification.

* For information regarding equivalent CPR levels for the Heart and Stroke Foundation of Canada, call the National Resuscitation Support Centre (RSC) at 1-877-473-0333. At the time of printing, the specified CPR levels were reflective of national listings by the Canadian Red Cross and St. John Ambulance Canada.

Standards of Practice Drug Administration Appendix D – Patient Consent and Disclosure Requirements


APPENDIX D – PATIENT CONSENT AND DISCLOSURE REQUIREMENTS A pharmacist shall obtain informed and voluntary consent for the administration of a drug and disclosure of information related to administration of a drug in accordance with applicable legislative and regulatory requirements.

For reference, the following overview provides a general understanding of who can provide consent (i.e. Consent Authorities) as well as documentation and information disclosure requirements. For further details and specifics beyond those provided in this appendix, refer directly to the applicable legislation and regulations.

CONSENT AUTHORITIES

Adult Patients

A pharmacist shall obtain informed and voluntary consent from an adult patient, provided that the patient has the capacity to consent.

A pharmacist can assume that an adult patient has the capacity to consent and make their own treatment decisions, unless the pharmacist has reason to doubt a patient’s capacity. Through communicating with the patient and obtaining required information to support the drug administration process, a pharmacist can confirm a patient’s capacity to consent by determining that the patient has the ability to:

understand information that is relevant to making a treatment decision, and appreciate the reasonably foreseeable consequences of a decision.

Mature Minors

A pharmacist can obtain informed and voluntary consent from a mature minor. A mature minor is one who is capable of understanding the nature and consequences of the treatment and has, therefore, legal capacity to consent to their treatment.

A pharmacist shall rely on their own judgment to ascertain whether a minor is sufficiently mature to make treatment decisions. The following factors can assist the pharmacist in assessing the maturity of a minor:

What is the nature, purpose and utility of the recommended medical treatment? What are the risks and benefits?

Does the minor demonstrate the intellectual capacity and sophistication to understand the information relevant to making the decision and to appreciate the potential consequences?

Is there reason to believe that the minor’s views are stable and a true reflection of their core values and beliefs?

What is the potential impact of the minor’s lifestyle, family relationships and broader social affiliations on their ability to exercise independent judgment?

Are there any existing emotional or psychiatric vulnerabilities? Does the minor’s illness or condition have an impact on their decision-making

ability?



Is there any relevant information from adults who know the minor (e.g. physicians)?

In situations where a pharmacist determines that a minor has the necessary maturity to make their own treatment decisions, all rights in relation to giving or withholding consent will belong to the minor. The parent or guardian will no longer have any overriding right to give or withhold consent.

Patient Agents

When administering a drug to an adult or mature minor patient who is not able to provide consent (e.g. emergency situation) and another individual indicates by direction or implication that they are the patient’s agent, the pharmacist shall take reasonable steps to confirm the identity of the individual who is acting as the patient’s agent and to confirm that the individual has the patient’s authorization to act on their behalf. The pharmacist shall consider the nature, purpose and process of the activity requiring consent, including the associated benefits and risks, when using professional judgment to accept consent from the patient’s agent in this situation.

Non-Mature Minors

For non-mature minors, a pharmacist shall obtain informed and voluntary consent from the patient’s agent. The patient’s agent shall be determined in accordance with the considerations and ranked order outlined in the Patients Lacking Capacity to Consent section.

Patients Lacking Capacity to Consent

When the pharmacist has been advised that a patient lacks capacity to consent or when the patient appears to lack the capacity to consent, a pharmacist shall obtain informed and voluntary consent from the patient’s agent. The pharmacist shall deal with the patient’s agent as represented by a substitute decision maker appointed by the patient through the Personal Directives Act or the Medical Consent Act (where completed prior to April 1, 2010) to make personal care decisions (including health care decisions) should the patient become incapable of making decisions.

In situations where a personal directive or medical consent appointment exists, the pharmacist shall request a copy of it, follow the instructions and general principles regarding personal care decisions set out in the directive and file it in the pharmacy records for the patient.

In situations where a personal directive or medical consent appointment does not exist (and for non-mature minors as referenced above), the pharmacist shall deal with the patient’s agent as represented by a substitute decision maker in the following ranked order:

Legal guardian (appointed by the court) Nearest relative (as applicable), in this order:

Spouse – includes married, common-law (partners living together for one year or more) and registered domestic partners

Child Parent



Person standing in loco parentis (in place of the parent) Sibling Grandparent Grandchild Aunt or uncle Niece or nephew Other relative

Public trustee

There is a limitation on the determination of the nearest relative by the ranked order. In order to be a substitute decision maker, the patient’s nearest relative shall meet the following criteria:

has been in personal contact with the patient over the preceding 12 months or has been granted a court order to waive the 12 month period (note that spouses are exempt from this 12 month personal contact requirement);

is willing to assume decision-making responsibility; knows of no person of a higher rank in priority who is able and willing to

assume decision-making responsibility; and makes a statement in writing to certify the relationship with the patient, that

they are willing to act as the substitute decision maker, and know of no person ranked higher in priority.

In addition, the pharmacist shall be satisfied through face-to-face discussions with the individual and using their professional judgment that the nearest relative can act as the patient’s agent given the nature and purpose of the treatment, the intellectual capacity of the individual and the impact on the patient.

DOCUMENTATION REQUIREMENTS

Documentation of Informed Consent

A pharmacist shall include documentation in the pharmacy records for the patient that informed and voluntary consent was obtained and from whom. Written consent from the patient or patient’s agent is not required. Documentation of consent in the pharmacy records for the patient shall include:

the name of the person who provided consent, and confirmation of consent (can be satisfied by checking a “consent obtained” box)

for the administration of the drug and for any applicable disclosure of drug administration information to the patient’s primary health care provider, other appropriate health care professionals and the local public health services office.

Documentation for Patients Lacking Capacity to Consent

For a patient who lacks the capacity to consent and a personal directive or medical consent appointment exists, a pharmacist shall obtain a copy of the Personal Directive or Medical Consent (where completed prior to April 1, 2010) and file it in the pharmacy records for the patient.



For a patient who lacks the capacity to consent / non-mature minors where the patient’s agent is the “nearest relative”, a pharmacist shall obtain and file written confirmation from the agent that they are the nearest relative (supported by a birth certificate or other identification), that they have been in personal contact with the patient over the preceding 12 months, is willing to assume decision-making responsibility with respect to the administration of the drug, and knows of no one who ranks higher in the hierarchy of relatives who is able and willing to assume decision-making responsibility.

For a patient who lacks the capacity to consent / non-mature minors where the patient’s agent is a legal guardian or public trustee, a pharmacist shall review the court issued order to confirm applicability and retain a copy of the documentation.

INFORMATION DISCLOSURE REQUIREMENTS

In accordance with section 3.9 of these standards, a pharmacist shall communicate any pertinent drug administration details to the patient’s primary health care provider, and/or other appropriate health care professionals, as appropriate.

There can be other circumstances that require or justify a pharmacist to disclose information without the patient’s informed and voluntary consent, including:

reporting suspected abuse related to the administration of medication in accordance with the Protection for Persons in Care Act (note that such reporting is not a mandatory duty for a pharmacist) ,

reporting an adult in need of protection in accordance with the Adult Protection Act,

reporting child abuse in accordance with the Children and Family Services Act, and

reporting notifiable diseases in accordance with the Reporting of Notifiable Diseases and Conditions Regulations.

Refer to the cited legislation for additional information regarding the disclosure of information in the above circumstances.

Standards of Practice Drug Administration Appendix E – Reciprocal Notification Form


APPENDIX E – RECIPROCAL NOTIFICATION FORM When vaccines that have been supplied and funded by Public Health Services (other than influenza) are administered to patients, pharmacists are required to submit and forward the Reciprocal Notification Form to local Public Health Services offices and provide a copy to the patient’s primary health care provider (as referenced in Standard 3.9.3). Note: At the time of publication of these Standards, the only vaccine that will be supplied to pharmacies by Public Health is the influenza vaccine, which does NOT require the submission of this form.

Standards of Practice Drug Administration Appendix F – Drug Administration Notification Form


APPENDIX F – DRUG ADMINISTRATION NOTIFICATION FORM The Drug Administration Notification Form shall be completed in accordance with Standard 3.9.2. Except for influenza vaccine administration, the Drug Administration Notification form is completed and forwarded to the patient’s primary health care provider and/or other health care professionals within 24 hours of the administration of the drug or as soon as possible thereafter for every instance of drug administration by injection and when appropriate for drug administration by other routes. Influenza vaccine administration requires documentation in the DIS, but does not require the submission of this form to the patient’s primary care provider.

If applicable and once results have been obtained, the Drug Administration Follow-Up Results portion is completed on a copy of the original form (showing the drug administration details and follow-up plan) and forwarded to the patient’s primary health care provider and/or other health care professionals within 24 hours of obtaining the follow-up results or as soon as possible thereafter.

Note: this form is

available as a fillable PDF on

the NSCP website:

nspharmacists.ca

Standards of Practice Drug Administration Notes


Notes: