Expanded Scope Orientation Manual - Ontario College of Pharmacists

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Table of Contents INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 How to use this Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Expectation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

PART 1: EXPANDED SCOPE ACTIVITIES . . . . . . . . . . . . . . . . . . . . .6 Principles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Initiating Therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 The Prescription . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Renewing or Adapting a Prescription . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Executing a Prescription Renewal or Adaptation . . . . . . . . . . . . . . . . . . 8 The Prescription . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Performing a Procedure on Tissue below the Dermis . . . . . . . . . . . . . . . . . . . . . . . . . 11 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Performing the Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Administering Substances by Injection or Inhalation . . . . . . . . . . . . . . . . . . . . . . . . . 12 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 General Guidance for the Administration of Injections and Inhalations . . . . 12 - Administration of Injections for the Purpose of Demonstration . . . . . . 13 - Administration of Inhalations for the Purpose of Demonstration . . . . . 13 - Administration of the Influenza Vaccine . . . . . . . . . . . . . . . . . . . . 14 Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Infection Prevention and Control . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Documentation and Notification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Notification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Documentation: Sample template . . . . . . . . . . . . . . . . . . . . . . . . . 17 Documentation: Template notes . . . . . . . . . . . . . . . . . . . . . . . . . . 18

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Table of Contents PART 2: THE HEALTH CARE DELIVERY FRAMEWORK . . . . . . . . . . . . 19 Interprofessional and Collaborative Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Patient Privacy and Access to Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 The Health Information Custodian (HIC) . . . . . . . . . . . . . . . . . . . . . . 20 Circle of Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Relying on Assumed Implied Consent in the Context of Releasing Personal Health Information . . . . . . . . . . . . . . . . . . . . . . 21 Resources for HICs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Consent to Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Principles of Informed Consent . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

PART 3: APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Appendix 1: Practice Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 1. Initiating a Prescription . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 2. Renewing a Prescription . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 3. Adapting a Prescription . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 4. Performing a procedure on the tissue below the dermis for education and chronic disease monitoring . . . . . . . . . . . . . . . . . . . 32 5. Administering a substance by injection or inhalation for the purpose of patient education and demonstration . . . . . . . . . . . . . 33 Appendix 2: Regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Appendix 3: Roles and Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Part A Pharmacist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Registered Pharmacy Student . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Intern . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Pharmacy Technician . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Expanded Scope: By Membership Class . . . . . . . . . . . . . . . . . . . . . . 45 Appendix 4: Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Chronic and Long-Term Condition . . . . . . . . . . . . . . . . . . . . . . . . . 46 Health Information Custodian . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Medication Therapy Management (MTM) . . . . . . . . . . . . . . . . . . . . . 46 Patient Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 Record Keeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 Self-administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

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Introduction In 2009, the Ontario government passed Bill 179, the Regulated Health Professions Statute Law Amendment Act, 2009. The purpose of the legislation is to ensure that Ontarians have access to the right number and mix of qualified health care providers, now and in the future, by expanding the scope of practice for a number of health professionals. The authorized acts enabled for the practice of pharmacy in the updated Pharmacy Act are: 1. D  ispensing, selling or compounding a drug or supervising the part of The expanded scope of pharmacy a pharmacy where drugs are kept. 2. Administering,  by injection or inhalation, a substance specified in the practice supports the delivery of regulations. 3. Prescribing  a drug specified in the regulations. safe and effective patient care by 4. Prescribing  a drug, other than a drug mentioned in paragraph 3, in permitting members to optimize accordance with the regulations. 5. Performing  a procedure on tissue below the dermis. patient outcomes. The expanded scope of pharmacy practice supports the delivery of safe and effective patient care by permitting members to optimize patient outcomes. While prescribing is not a legally defined term, in the context of the regulation, prescribing refers to initiating therapy, and adapting or renewing prescriptions. Once the member has assessed the patient and established the need for an action related to the expanded scope, communicating with the patient is the key to engaging support and consent for the member’s actions. The member concludes the activity by documenting his or her actions in the patient record, including the rationale, and notifying the prescriber, as necessary. Part 1 of this manual provides members with an overview that will support the exercise of their expanded scope of pharmacy practice: 1. Initiating a Prescription; 2. Adapting or Renewing a Prescription; 3. Performing a Procedure on Tissue below the Dermis; and 4. Administering Injections or Inhalations. This section also includes information related to documentation, including a template that can be used for this purpose. Part 2 of the manual presents a summary of the fundamentals that support the delivery of patient care in Ontario, including an outline of interprofessional and collaborative care, patient privacy, and access to personal health information, informed consent to treatment and documentation and notification. These sections also contain references to allow the practitioner to access more detailed information.

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Appendices: Appendix 1 is comprised of practice examples that illustrate the application of the expanded scope in the context of specific scenarios, and how a member might document the rationale for clinical decision-making and create notes for monitoring and follow-up. Appendix 2 of this manual contains the wording of the regulation and Appendix 3 summarizes the roles and responsibilities of the different classes of members. Finally, Appendix 4 provides definitions of some key terms. As members move forward to maximize their full educational and professional competencies, they will be challenged to change the way that they provide care and services to patients. Fortunately, in Ontario the integration of regulated pharmacy technicians has preceded the expanded scope of pharmacy practice, permitting workplaces to have the pharmacist focus on the therapeutic aspects of care while the pharmacy technician takes on a greater role in the technical aspects of dispensing.

How to use this Manual The manual is organized by first outlining the minimum expectations of the College for a member to initiate therapy, renew or adapt a prescription, perform a procedure on tissue below the dermis, administer an injection or inhalation therapy or administer an influenza vaccine as part of the Universal Influenza Immunization Program. In providing care, members are also required to meet the standards of professional practice and uphold the Code of Ethics of the profession. Additionally The expectation of the College they have a fiduciary duty to act in the patient’s best interests and practice within legal requirements, including all relevant federal and is that prior to exercising the provincial legislation.

expanded scope, members will review and understand both the regulation and the information contained in this manual. On renewal in March 2013, the College will ask all members to declare that they have done so.

The summaries in Part 2 provide information related to collaborative care, patient privacy, access to information, and consent to treatment. This information is meant to supplement the practice of the expanded scope and provides an overview of Ontario’s health care delivery framework. Members are encouraged to review the College’s Documentation Guidelines for more information on documenting patient care and the Record Retention, Disclosure, and Disposal Guideline for an overview of the legal requirements associated with creating and keeping patient records.

Expectation The expectation of the College is that prior to exercising the expanded scope, members will review and understand both the regulation and the information contained in this manual. On member renewal in March 2013, the College will ask all members to declare that they have done so. page

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Part 1: Expanded Scope Activities This information has been prepared to assist members in the implementation of their expanded scope of practice.

Principles The following principles underlie practice. 1. Members have an obligation to protect and promote the health and well-being of patients; 2. Members are accountable for practicing within their scope of practice, the terms, conditions and limitations on their certificate of registration, if any, and in accordance with their knowledge, skill, and judgment; 3. The services included within the expanded scope of pharmacy practice are part of ongoing medical care and take place in the context of a collaborative relationship between the pharmacist, the patient, and the patient’s primary health care provider; 4. Members initiate, adapt and renew prescriptions, administer substances by injection or inhalation only for the benefit of the patient and based on the individual nature of the patient’s need/history and professional judgment exercised accordingly; 5. When initiating, adapting and/or renewing prescriptions, the member assumes full responsibility and liability for that prescription, documents actions as required, and undertakes notifications as appropriate; and 6. Pharmacy services are provided within the context of the legislative requirements, Standards of Practice, and Code of Ethics.

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Expanded Scope Activities

Initiating Therapy Introduction Prescriptions may be initiated for the purpose of smoking cessation in the following circumstances: 1. The treatment is in the best interest of the patient; 2. The drug is specified in the regulations; 3. The member has the knowledge, skill, and judgment, with regard to the drug and the condition for which the member is prescribing it, to prescribe a drug safely and effectively; and 4. The member determines that the drug is safe and effective, considering the known risks and benefits to the patient and other relevant factors As specified in the regulation specific to the situation including: pharmacists can initiate, for the a. The patient’s symptoms; b. Co-existent disease states and chronic conditions; purpose of smoking cessation, c. T  he patient’s allergies and other contraindications and precautions; a prescription for either; d. O  ther medications the patient may be taking; e. T  he patients’ gender, age, and weight; Varenicline or Bupropion f. Pregnancy and lactation status, if applicable; and g. A  ny other inquiries reasonably necessary in the circumstances. 5. The member discusses the therapy, including risks and benefits, with the patient or his or her authorized agent and consent is given for the treatment. 6. The patient or his or her authorized agent understands that the prescription can be taken to another pharmacy for dispensing. 7. The member documents his or her rationale for initiating smoking cessation therapy in the patient record. 8. The member notifies the patient’s primary health care provider within a reasonable time when initiating smoking cessation therapy.

The Prescription A member who prescribes a drug is required to prepare a prescription which includes the following: 1. The name and address of the person for whom the drug is prescribed; 2. The name, strength (where applicable) and quantity of the prescribed drug; 3. The direction for the use of the drug, including its dose, frequency, route of administration, and any special instructions; 4. The name, address, telephone number, College registration number and signature of the member issuing the prescription; 5. The date the prescription was issued by the member; and 6. The number of refills that the member has authorized, if applicable.

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Expanded Scope Activities

Renewing or Adapting a Prescription Introduction In 2011, changes to the regulations under the Drug and Pharmacies Regulation Act (DPRA) provided pharmacists with the authority to refill prescriptions in specific circumstances. Those provisions are revoked and replaced by the members’ independent authority to renew prescriptions, as per this regulation.

In light of this new regulation, pharmacists’ authority to refill prescriptions under the Drug and Pharmacies Regulations Act (DPRA) is revoked.

Medication therapy management optimizes therapeutic outcomes for individual patients utilizing a member’s unique knowledge and experience. Prescribing includes the ability of the member to renew or adapt a prescription based on the patient’s individual circumstances.

Narcotics, controlled drugs and targeted substances Members do not have the authority to renew or adapt a narcotic, controlled drug, or targeted substance, nor a drug designated as a monitored drug under the Narcotic Safety and Awareness Act.

Considerations A member will consider renewing or adapting a prescription only in the following circumstances: 1. The member has determined the drug will be safe and effective, considering the relevant circumstances of the patient, including, but not limited to the following: a. The patient’s medical history, including co-morbid disease states and chronic conditions; b. Laboratory or other tests as available; c. Symptoms reported by the patient; d. The patient’s allergies and other contraindications and precautions; e. Other medications the patient may be taking; f. The patients’ gender, age, weight and height (where applicable); g. Pregnancy and lactation status, if applicable; h. Any other inquiries reasonably necessary in the circumstances including those with respect to the use of cigarettes and alcohol. 2. The drug is prescribed in a circumstance which is within the member’s area of practice, knowledge, and skills.

Executing a Prescription Renewal or Adaptation 1. A prescription may be renewed or adapted for the purpose of medication therapy management where the member has: a. Considered the potential risks and benefits to the patient of adapting or renewing the prescription; b. Determined that a prescription renewal or adaptation is in the best interest of the patient; and

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Expanded Scope Activities c. The member is in possession of the existing order or prescription to be renewed or adapted, or has access to the information contained in the original prescription (copy, verbal confirmation from the pharmacy, or medical record).

Renewal 2. The member will renew the prescription based upon the circumstances of the particular patient: a. The medication to be continued is for a previously diagnosed chronic and long-term condition; and b. The patient has tolerated the medication without serious side effects. 3. The member shall not prescribe a quantity of the drug that exceeds the lesser of: a. The quantity that was originally prescribed, including any refills that were authorized by the original prescriber; or b. A six month’s supply.

Adaptation 4. The member will adapt the prescription based upon the circumstances of the particular patient by altering the dose, dosage form, regimen, or route of administration to address the patient’s unique needs and circumstances. This does not include therapeutic substitution.

Consent 5. When the member renews a prescription, he or she may rely on the consent that the patient, or his or her authorized agent, has already given to the prescriber for their treatment. However, if in the member’s professional judgment a proposed adaptation is clinically significant, it is appropriate to seek an additional consent from the patient or his or her agent. A good indication of whether to seek consent is whether the member considers the change significant enough to inform the prescriber of the adaptation.

Choice 6. The patient or his or her authorized agent has the option of having the prescription dispensed immediately or may choose to take it to another pharmacy.

Documentation 7. Prescription information is: a. Recorded by the member at the time of prescribing, and b. Documented in the patient record. 8. The prescription, or a copy thereof, should be kept together or linked to the original prescription. The member’s documentation of his or her rationale for prescribing should be linked to the renewed or adapted prescription and be easily retrievable.

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Expanded Scope Activities Notification The purpose of notification is to ensure continuity of care: 9. In the case of a prescription renewal, the member notifies the original prescriber and, if known to the member and different from the original prescriber, the patient’s primary health care provider. 10. Where an adaptation is clinically significant, the member notifies the original prescriber and, if known to the member and different from the original prescriber, the patient’s primary health care provider. Notification of a prescription renewal or adaptation should take place within a reasonable period of time. The member does not have to ensure receipt of the notification.

The Prescription A member who renews or adapts a previously issued prescription must ensure the following information is recorded on the prescription: 1. The name and address of the person for whom the drug is prescribed; 2. The name, strength (where applicable) and quantity or amount of the prescribed drug; 3. The direction for the use of the drug, including its dose, frequency, route of administration, and any special instructions respecting the use of the drug; 4. The name, address, telephone number and College registration number of the member; 5. The signature of the member; 6. The date the prescription was issued; 7. The number of refills that the member has authorized, if applicable; and 8. A reference to the original prescription that the member renewed or adapted, including the name and contact details of the original prescriber.

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Expanded Scope Activities

Performing a Procedure on Tissue below the Dermis Introduction Training, educating and counselling patients or informal care givers on chronic disease management and the appropriate use of monitoring devices is a core competency of pharmacy.

Considerations The member will only consider performing the procedure if he or she has the knowledge, skill, and judgment to do so safely and effectively with regard to the proper techniques for performing the procedure. The member must have an understanding of the value and limitations of self care devices and monitoring tools and be able to educate the patient on how to self monitor and when to contact a health professional. A pharmacy technician is authorized to perform this procedure under the direction of a Part A pharmacist who is physically present on the premises.

Performing the Procedure With the consent of the patient or his or her authorized agent, the member may pierce a patient’s dermis to demonstrate the proper use of lancet-type devices for the patient’s self care and education or for the patient’s self monitoring of his or her chronic disease. The member will: 1. Make a determination that the procedure is appropriate for the patient having considered the potential risks and benefits to the patient of performing the A pharmacy technician procedure, and other relevant factors specific to the situation including the safeguards and resources available in the circumstances to safely manage the is authorized to perform outcome of performing the procedure; 2. Explain the purpose of the demonstration to the patient or his or her this procedure under authorized agent; the direction of a 3. Maintain an appropriate environment in which the procedure is to be administered. Such area shall be clean, safe, appropriately private, and Part A pharmacist who comfortable for the patient; is physically present on 4. Adhere to the Standards of Practice; 5. Follow good infection control procedures to help prevent the spread of the premises infection; and 6. Document and maintain relevant records as appropriate.

Documentation A member who performs a procedure on tissue below the dermis will make a record that includes: 1. The name and address of the patient and the member performing the procedure; 2. The date the act was performed and results, if any; and 3. Confirmation of consent by the patient or his or her authorized agent.

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Expanded Scope Activities

Administering Substances by Injection or Inhalation Introduction Training and educating patients or care givers to appropriately use medication is a core competency of pharmacy. Once a patient receives a prescription for a selfadministered injection or inhalation of a substance specified in the regulation, the patient or his or her authorized agent has the choice of having the injection/inhalation both dispensed and administered by the member for the purpose of Both students and interns, education and demonstration without having to wait for access to another health professional.

under the direction of a Part A pharmacist,

are authorized to administer injections or inhalations for the purpose of education or demonstration

A member is required to have completed training and to have valid certification in CPR and First Aid prior to exercising his or her authority to administer injections. The member must also register the completion of injection training with the College. A list of approved courses can be found on the College website along with instructions on how to register. In the case of the influenza vaccine, only a Part A pharmacist located in a pharmacy approved to participate in the Universal Influenza Immunization Program (UIIP) is permitted to administer an influenza injection.

Considerations The member will assess the risk of administering the prescribed substance to the patient and ensure that emergency protocols are in place, and that they are sufficient to address the risks of administering the specific substance. The utilization of a drug administration check list is recommended.

General Guidance for the Administration of Injections and Inhalations The member may administer injections and inhalations for the purpose of patient education and demonstration, or for the purpose of administering the influenza vaccine in a UIIPapproved pharmacy, in the following circumstances: 1. The member has been certified in first aid and cardio-pulmonary resuscitation as required by the Standards of Practice; 2. The drug is specified in the regulations and is prescribed for self-administration; 3. The member has the knowledge, skill and judgment with regard to the drug and its administration; 4. The member has explained the purpose of administering the substance to the patient or his or her authorized agent; 5. The member has determined the drug will be safe to administer considering the storage requirements of the drug, including protecting the cold chain, and the relevant circumstances of the patient, including but not limited to: a. The potential risks and benefits;

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Expanded Scope Activities b. The safeguards and resources available in the circumstances to safely manage the outcome of administering the substance; and c. Any factors specific to the situation. 6. The patient or his or her agent has consented to the administration of the substance; 7. The member confirms: the right patient; the right drug; the right dose; the right route; the right reason, the right time, and the right documentation; 8. Other than when administering an influenza vaccine in a UIIP-approved pharmacy, the member administers the substance only for the purpose of demonstrating how to do so to the patient or their care giver; 9. The member administers the substance in an environment that is clean, safe, private, and comfortable for the patient; 10. The member insures that there is an inventory of appropriate drugs and is prepared to treat a possible emergency; 11. The member has appropriate infection control procedures in place, including when a drug is administered in the patient’s home; 12. The member provides post-therapy observation for the suggested duration following administration of the substance and ensures that the appropriate support is available to the patient; and 13. The member communicates any clinically significant information to the original prescriber or primary health care provider.

Administration of Injections for the Purpose of Demonstration Substances for administration by injection are listed in Table 1 of the regulation

The member is required to have completed the required training and indicated completion on the College register. It is important that before a member administers an injection he or she assesses the patient to determine if there are any changes in their health status that contraindicate the administration of the prescribed substance. A member will not administer an injection to a child under 5 years old.

The member will: 1. Develop and maintain a policy and procedure manual for provision of this service which addresses appropriate aseptic techniques, documenting informed consent, handling emergencies and disposing of sharps. Review annually and revise as needed; and 2. E  nsure the patient has the appropriate supplies for self administration and aseptic technique.

Administration of Inhalations for the Purpose of Demonstration The member will: 1. Develop and maintain a policy and procedure manual for provision of this service including documenting informed consent and handling emergencies. are listed in Table 2 of the Review annually and revise as needed; 2. Demonstrate correct technique based on the type of inhaler required by the regulation patient; 3. Have the patient/care giver demonstrate his or her inhaler technique. Review the technique until the patient/care giver is able to repeat the demonstration; 4. Provide patient information highlighting the steps needed for correct self-administration.

Substances for inhalation

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Expanded Scope Activities Administration of the Influenza Vaccine A Pharmacist may only administer the influenza vaccine within the context of the Universal Influenza Immunization Program (UIIP). The UIIP is Ontario’s program to provide individual protection against influenza, reduce the number and severity of influenza cases, and decrease the economic impact of influenza. Information requests regarding Only those pharmacies that have been prequalified and inspected by the local public health unit will receive publically-funded influenza vaccine. the UIIP should be directed to The College’s Cold Chain Policy is a policy requirement of the College for the protection of all temperature-sensitive pharmaceutical and biologic the Ministry of Health and Long products that are at risk of damage if handled improperly and is aligned to Term Care (MOHLTC) at the requirements of the UIIP.

[email protected]

Only Part A pharmacists are permitted to administer the influenza vaccine. The pharmacist will administer the vaccine by injection to a patient who is five years of age or older, if the pharmacist: a. Administers the vaccine in accordance with the UIIP; b. Receives an informed consent from the patient or his or her authorized agent; and c. Adheres to all other requirements for administering substances by injection.

Documentation The member must maintain a patient record that includes: 1. The informed consent of the patient or his or her authorized agent; 2. The name and address of the patient and the member; 3. The name of the substance and total dose administered; 4. The lot number and expiry date of the substance, where necessary; 5. The date of the administration; 6. The circumstances relating to the administration of the substance or influenza vaccine to the patient and any adverse reaction experienced by the patient; and 7. Details of communication to the original prescriber or primary health care provider, if any.

Environment When the member administers a substance (or performs a procedure below the dermis) he or she must do so in an environment that is clean, safe, private, and comfortable for the patient. Every pharmacy in Ontario is required to have a dispensary which has the capacity for cleaning the equipment involved in the preparation, dispensing, distribution, and storage of drugs and a sink with a supply of hot and cold running water. It is expected that suitable attire and protective coverings will be utilized as necessary. A number of injectable and inhaled medications require refrigeration, so it is important to ensure that the refrigerator is of sufficient size to store drugs and that is maintained at the proper temperature, as suggested by the manufacturer and in alignment with the College’s Cold Chain Policy.

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Expanded Scope Activities Point-of-use disposal receptacles and puncture resistant containers with clear labels, a handle, and tight fitting lid to reduce risk of leakage are appropriate for the disposal of sharps. It is recommended not to recap, bend, or manipulate needles when disposing of used sharps.1

Infection Prevention and Control The College has developed a resource for members, Infection Control for Regulated Professionals: Pharmacists’ Edition, which describes the appropriate precautions that should be taken in community settings. Infection control practices must meet professional requirements including the application of evidence-based measures and professional judgment. Where members are employees, the guideline specifies the requirement to abide by the employers’ infection control program. Members must follow all government recommendations on health alerts, surveillance, screening and reporting of respiratory and influenza - like illness. The Infection Control Guideline takes a ‘routine precaution’ approach: routine precautions, including hand washing, use of personal protective equipment, etc. should be undertaken at all times, with all patients. It is recommended that members take steps to prevent spreading infectious diseases, including that immunizations are up-to-date and that the member has an annual influenza vaccination.

1. Canadian Committee on Antibiotic Resistance (2007) Infection Prevention and Control Best Practices for Long Term Care, Home and Community Care including Health Care Offices and Ambulatory Clinics.

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Expanded Scope Activities

Documentation and Notification The College has published a Documentation Guideline which establishes the expectations of the College for the documentation of patient care.

Documentation Depending on the practice setting as well as the circumstances which warrant an adaptation or prescription renewal, members must use professional judgment in choosing a documentation style and determining how much information to convey to an original prescriber. If possible, members should collaborate with the prescribers with whom they frequently interact in order to determine the best way to implement the expanded scopes of practice in a manner that will ensure continuity of patient care. The member is expected to be consistent when documenting his or her rationale for prescribing, taking into account the assessment of the patient, including their best interests, and the circumstances under which the drug is prescribed. Members may wish to note a follow up or monitoring plan as well.

Notification The notification provisions of the regulation specify that a member will notify a prescriber within a reasonable time after initiating or renewing a prescription, and if he or she has adapted a prescription in a manner that is clinically significant. In scenarios which involve a simple adaptation such as a solid to a liquid formulation, the member may consider that this adaptation is not clinically significant in the circumstances of the patient and may choose not to notify the prescriber about the adaptation. However, in situations where, in the view of the member, adapting the The documentation/ prescription will likely have clinically significant outcomes, the member must notify the prescriber.

notification template found

in this manual can be used as is, or adapted to suit the member’s needs

In the event that the member decides to share additional information with the prescriber, it is recommended to be as brief and concise as possible. When notifying the prescriber the member may wish to provide additional information (i.e. rationale and/or monitoring/follow-up plan) so that the patient record is complete in both locations. Depending on the situation, the member may choose to notify the prescriber utilizing the template in this manual.

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Expanded Scope Activities

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Expanded Scope Activities

Documentation: Template notes The preceding template may serve as a sample and guide to the requirements needed for documentation and/or notification purposes. It is a NOT a stand alone document and each practice setting may interpret and develop their own method and criteria for documentation and notification purposes for expanded scope of practice. The following information may appear in the patient record and/or in the documentation notes to be linked with the patient record or notification to the original prescriber: Patient Information – This section contains the patient’s full name and current address. Depending on the computer software available at the pharmacy, this section may contain additional information including phone number, email address, emergency contact, allergies etc. Pharmacist Information – This section will contain the name and the registration number of the pharmacist issuing the prescription. This information along with other pertinent information such as the address and telephone or fax number of the pharmacy, will need to be communicated and/ or forwarded to an original prescriber, should the pharmacist decide to notify them. Prescription Information – The purpose of this section is to provide an effective method that displays and links the original prescription to an adapted/renewed prescription where relevant. Depending on the documentation practices, patient record or electronic software available at the pharmacy, the intent of this section is to allow for information to be easily retrievable and accessed. Where applicable, reference to the prescription that the pharmacist adapted or renewed, including the name and contact details of the original prescriber must be included. It should be noted that prescription details (such as name, strength, quantity, duration) are needed for both original and adapted prescriptions. It is up to the pharmacist to decide whether or not they would like to attach a copy of the original prescription, for quick reference purposes as long as the method allows for prescription information to be easily retrievable. Rationale for Prescribing – The intent of this section is to allow the pharmacist to document their thought process when he or she chooses to prescribe. The pharmacist is expected to have considered the best interests of the patient, conducted an assessment, considered any available laboratory test information, potential drug therapy problems, and/or other considerations that warrant a prescription to be adapted or renewed. The key is to be concise and brief in the documentation, especially if the pharmacist chooses to share their rationale to the original prescriber. Monitoring/Follow-up Plan – This section needs to be sufficiently detailed in order to monitor the patient’s progress. The pharmacist may choose to share their monitor/follow-up plan with another regulated health professional and/or original prescriber if they believe that it would ensure continuity of care to their patient. Notification Information – when an adaptation is clinically significant and in the case of a prescription renewal, it is a requirement to notify the original prescriber within an appropriate timeframe. The name of the original prescriber, date, and method of notification and/or other pertinent caregivers must be included within the documentation and/or patient record.

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Part 2: The Health Care Delivery Framework Interprofessional and Collaborative Care The delivery of a new scope of practice is not a stand-alone or isolated opportunity. While members of the pharmacy profession have always worked closely with other health professionals in the delivery of patient care, the expanded scope of practice is based upon both more coordination and more independence in practice. Interprofessional care takes place within the context of a collaborative team-based approach to providing care by multiple health professionals through the provision of comprehensive services. The collaborative relationship is founded upon the expectations of each participant, including patients, to support mutual therapy goals through sharing relevant health information. Interprofessional care can provide numerous benefits including improved patient care and safety, access, enhanced provider satisfaction and better organizational efficiency. Interprofessional care can also contribute to system innovation and sustainability.2 Research has confirmed that incorporating pharmacists into the circle of care can help optimize prescribing and use of medications, thus helping to reduce drug-related problems and subsequent medication-related hospitalizations.3 Interprofessional care The delivery of a new scope is particularly important for the effective treatment of patients with chronic disease. The intervention of members in chronic disease management in of practice is not a standcollaboration with other health professionals has also been found to improve management of asthma, medication compliance in the elderly, and to reduce alone or isolated opportunity the number of hospitalizations of those suffering from heart failure.4 Collaborative care may be instituted in the community or institution within the context of established inter-professional relationships or through the shared management of a patient with a chronic medical condition. Regardless of the determining factor, communication is the key to efficient and effective collaborative care. Appropriate communication strategies can improve patient safety and health outcomes as well as help to avoid the duplication of services. Many members already have experience in the delivery of collaborative care through the provision of methadone maintenance treatment and dispensing, and through the provision of services funded through Ontario Public Drug Programs which support collaboration between pharmacists and prescribers.5

2. HealthForceOntario Interprofessional Care: A Blueprint for Action for Ontario; p.15. July 2007. 3. The Translator Pharmacists help optimize prescribing in primacy care settings. Canadian Pharmacists Association, 2009 4. Ibid. 5. Ministry of Health and Long-Term Ontario Public Drug Programs

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The Health Care Delivery Framework

Patient Privacy and Access to Information As regulated health professionals, members of the College are required to meet the record keeping standards in place for all health professionals. These rules require the pharmacy to maintain patient records for 10 years from the last date that patient care was provided or until 10 years after the day on which the patient reaches or would have reached the age of 18 years, whichever is longer, and to ensure the confidentiality of patient information. These obligations are not new with the expanded scope of practice; however, given that members will be providing new services, it is important that they review the requirements related to privacy and access, in order to ensure that they are fully informed of the rules. The College’s Record Retention, Disclosure, and Disposal Guideline provides guidance to members in this area. The following is a general overview of privacy and access rules and contains links to primary sources for those who wish to know more.

The Health Information Custodian (HIC) No person may examine a patient health record or access information from a record except as required and permitted by law.6 A HIC is a person or organization that has custody or control of personal health information, including doctors, hospitals, long-term care facilities, health care clinics, laboratories, the Ministry of Health and Long-Term Care, and other health-related organizations.7, 8 Pharmacies are HICs as defined by the Act.9 The owner of the pharmacy is ultimately accountable for the personal health information collected and retained within the pharmacy, including with respect to a remote dispensing location if any; however, the Designated Manager must ensure that: • The pharmacy practice meets the requirements of legislation and regulation and that patient health information is collected and stored appropriately; • The appropriate policies and procedures required to use, protect, store and dispose of personal health information are in place; • Staff receive training on their duties with respect to personal health information; • The appropriate record retention schedules are in place; and • Back up and recovery systems are maintained according to legislated standards. The Ministry of Health and Long-Term Care has several resources in place for those who wish to know more about the role of the health information custodian.10

6. Information and Privacy Commission or Ontario A Guide to the Personal Health Information Act December 2004 7. Government of Ontario Personal Health Information Protection Act, 2004 8. Ontario Ministry of Health and Long-Term Care Health Information Protection Act, 2004 9. Ibid. 10. O  ntario Ministry of Health and Long-Term Care Personal Health Information Protection Act, 2004: An Overview for Health Information Custodians.

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The Health Care Delivery Framework Circle of Care The circle of care is a term commonly used to describe the health information custodians’ ability to assume an individual’s implied consent to collect, use or disclose personal health information for the purpose of providing health care.11 Clinical information can only be shared with other health providers currently involved in the patient’s care. When, in the course of providing care, the member establishes a relationship with the patient or his or her agent and other providers included in the circle of care the member may then assume they have implied consent to collect, use, and/or disclose personal health information with the other providers. The member is permitted to confer about test results and discuss symptoms and treatment options with other members of the health care team without needing to seek additional consent from the patient or substitute decision maker.

Relying on Assumed Implied Consent in the Context of Releasing Personal Health Information There are six criteria that must be met before a health information custodian can assume implied consent to share personal health information: 1. The HIC must fall within a category of health information custodians that are entitled to rely on assumed implied consent, for example, health care practitioners, long-term care homes and community care access centres are all entitled to rely on assumed implied consent. 2. The personal health information to be collected, used, or disclosed by the health information custodian must have been received from the individual, his or her substitute decision-maker, or another health information custodian. 3. The HIC must have received the personal health information that is being collected, used or disclosed for the purpose of providing or assisting in the provision of health care to the individual. 4. The purpose of the collection, use, or disclosure of personal health information by the HIC must be for the provision of health care or assisting in the provision of health care to the individual. 5. The disclosure of personal health information by the HIC must be to another health information custodian. 6. The individual has not expressly withheld or withdrawn consent to the personal health information being collected, used, or disclosed. In the event that an individual has blocked access to their personal health information, it is up to the receiving HIC to seek consent to access the information directly from the individual.12 More information on sharing information within the circle of care can be accessed at http://www.ipc.on.ca/images/Resources/circle-care.pdf 13

11. Information and Privacy Commissioner Circle of Care: Sharing Personal Health Information for Health-Care Purposes. 12. Cavoukian, A (2005). Lock-box Fact Sheet. Fact Sheet #8, July 2005. 13. O  ffice of the Information and Privacy Commissioner Circle of Care: Sharing Personal Health Information for Health-Care Purposes. September 2009.

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The Health Care Delivery Framework Resources for HICs The legislation regarding the collection, use, disclosure, retention, and disposal of personal health information is complex. HICs are encouraged to review materials offered by the Information and Privacy Commissioner, including A Guide to the Personal Health Information Protection Act and the resources provided by the Ministry of Health and Long-Term Care.14, 15 The member may wish to create his or her own template to authorize the disclosure of a patient’s personal health information to another person or utilize the sample form provided by the Ministry of Health and Long-Term Care for use by a health information custodian.16 Individuals who wish to access their own personal health information may use the sample form supplied by the Information and Privacy Commissioner.17

14. Information and Privacy Commissioner A Guide to the Personal Health Information Protection Act December 2004. 15. Ontario Ministry of Long-Term Care Health Information Protection Act, 2004 16. M  inistry of Health and Long-Term Care Consent to Disclose Personal Health Information Pursuant to the Personal Health Information Protection Act, 2004 (PHIPA) 17. Information and Privacy Commissioner Request to Access Personal Health Information

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The Health Care Delivery Framework

Consent to Treatment There are many terms relevant to pharmacy practice that are used when discussing the concept of consent to treatment, including, for example, informed consent, implied consent and included consent. A person is said to have given informed consent to treatment when they have received enough information from a health practitioner to make a decision about the treatment and have had an opportunity to ask questions and receive further information as necessary. The health practitioner who proposes a treatment is, in fact, obligated to seek the patient’s informed consent.

Principles of Informed Consent 1. The best interests of the patient are central to all member/patient interactions. 2. Respect for the autonomy and personal dignity of the patient is central to the provision of ethically sound patient care. The individual has a fundamental right to decide which medical interventions will be accepted and which will not. 3. In order to exercise his or her autonomy, the patient must be capable of The health practitioner who making informed decisions about their health care. 4. The goals of the Health Care Consent Act, 1996 (HCCA) include promoting proposes a treatment is, in individual autonomy and decision-making capacity, and facilitating communication between health care practitioners and their patients. fact, obligated to seek the 5. Members have the obligation to secure consent and patients have the legal patient’s informed consent right to either consent to or refuse treatment. 18

Included consent Unless it is unreasonable to do so, in most cases a member may rely on the notion of an ‘included consent’ to treatment when adapting or renewing a prescription.19 According to the Health Care Consent Act, a health practitioner is entitled to presume that a consent to treatment that has previously been given includes consent to variations or adjustments in the treatment, as well as consent to the continuation of the same treatment in a different setting. Where the member renews a prescription, the member is entitled to presume that consent has already been given for the treatment, however patients should be informed of therapy being provided. Where the member adapts a prescription, the member must rely on his or her professional judgment to determine whether an adaptation of the patient’s treatment is significantly different from the original treatment in its nature, expected benefits, material risks, and material side effects. If there is a significant difference, the member must seek a new consent from the patient or his or her agent.

Implied consent Generally, consent to treatment is given directly by the patient or his or her agent, implied consent on the other hand, occurs when surrounding circumstances are such that a reasonable person believes that consent had been given, although no explicit words of agreement have been uttered.20 Members may rely on implied consent for the purpose of

18. I College of Physicians and Surgeons of Ontario. Consent to Medical Treatment. January/February 2006. . . 19. Health Care Consent Act, 1996, 1996, S.O. 1996, Chapter 2, Schedule A; s.12 20. College of Physicians and Surgeons of Ontario Consent to Medical Treatment. January/February 2006; Endnote 11

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The Health Care Delivery Framework health planning and management, risk assessment, education and reimbursement, and/ or verification of claims and when filling a prescription or fulfilling a prescription transfer. For example, when a patient presents a prescription, requests a prescription transfer, or asks for a prescription refill, the patient is providing implied consent for the member’s subsequent technical and cognitive activities. The expanded scope of pharmacy practice creates an obligation on members to receive a patient’s consent in specific circumstances, including when initiating treatment, administering a substance or when performing a procedure on tissue below the dermis. The member will also need to determine whether consent is required in other circumstances, including when proposing an adaptation to a current prescription if it is considered to be clinically significant. There is no minimum age of consent in Ontario; consent is contingent on an individual’s capacity to understand why and for what the consent is being sought. Consent does not necessarily need to be in writing, but should be noted on a patient record along with a brief overview of the information that was provided to the patient concerning the risks, benefits, and potential side effects of the proposed treatment. The practice examples included in Appendix 1 will help to illustrate circumstances where consent is required and how it could be documented.

Substitute decision making The Health Care Consent Act, 1996 outlines the rules related to substitute decision-making and sets out the following hierarchy of individuals/agencies who may give or refuse consent on an incapable person’s behalf: 1. Guardian 2. Attorney for personal care 3. Representative appointed by Consent and Capacity Board 4. Spouse or partner 5. Child or parent or individual/agency entitled to give or refuse consent instead of a parent (this does not include a parent who has only a right of access) 6. Parent with right of access only 7. Brother or sister 8. Any other relative (related by blood, marriage or adoption) 9. Public Guardian and Trustee The highest-ranking person on this list, if available, capable, and willing, is the substitute decision maker for the incapable person.21 In the context of this manual, the substitute decision maker is also referred to as the ‘agent’ of the patient.

21. College of Physicians and Surgeons of Ontario Consent to Medical Treatment.

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Part 3: Appendices Appendix 1: Practice Examples 1. Initiating a Prescription Example 1.0 Initiating a Prescription Mr. GF is at the dispensary for cough drops for a cold and during the conversation with the pharmacist reveals that he feels like his cough is so bad due to smoking. The pharmacist determines that he would like to quit smoking and feels ready to do so, and is not currently using any smoking cessation therapy. The pharmacist offers support and to prescribe therapy for smoking cessation. The pharmacist and Mr. GF discuss the various treatment options and decide upon bupropion as the treatment of choice. Mr. GF states that he does not currently have a primary care physician and regularly uses a walk-in clinic in the area. The pharmacist prescribes bupropion

N/A

XXXXXXXX 10/11/2012

N/A

Bupropion 150mg X 3d then increase to 150mg bid (patient to set a quit date during 2nd week of therapy) Qty: 12 weeks 4

Jane Doe, RPh XXX-XXX-XXXX

- the patient is ready to initiate cessation therapy - patient does not have any contraindication to therapy (i.e. history of seizure, history of eating disorder etc.)

- counselled patient on directions for use and to contact pharmacist if experiencing any side effects - set-up dates for follow-up calls with patient at 1 week, 1 month - informed patient to notify physicians of this therapy

4

N/A (no primary care provider) page

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Practice Examples 2. Renewing a Prescription Example 2.0 Renewing a Prescription Mrs. DL enters the pharmacy on a Friday night asking for the pharmacist’s help with a situation involving her atorvastatin medication. On return from vacation Mrs. DL discovered that their regular physician is away for holidays for the next 3 weeks. She only has 1 week of medication left and will be leaving for a business trip on Sunday to Asia for the next 3 weeks. Mrs. DL requests that the pharmacist dispense her atorvastatin medication. On checking her health records the pharmacist notes that she has been on atorvastatin 40 mg i tab daily for the past 2 years. Her last prescription was filled at this pharmacy and the quantity indicated was for 90 days with 3 refills. Further questioning revealed that her last check up was several months ago, and all lab results appeared normal. The pharmacist renews the patient’s prescription X 90 days

XXXXXXXX 10/22/2011

10/11/2012

Atorvastatin 40mg i tab daily X 90 days Refills X 3

renewal of atorvastatin i tab daily X 90 days Dr. X

4

XXX-XXX-XXXX

- patient leaving for trip for next 3 weeks needs extension - stable dose and cholesterol levels X 2 years

- advised patient to set up appointment with physician

4 Dr. X 10/11/2012 XXX-XXX-XXXX

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Practice Examples 3. Adapting a Prescription Example 3.0 Incomplete Information Ms. HF enters the pharmacy with a prescription for venlafaxine XR daily. No strength was indicated on the prescription. The pharmacist checks the patient records and notes that she has been on venlafaxine 150 mg XR for the past 18 months. Upon questioning her, the pharmacist finds out that her physician has indicated for her to continue the venlafaxine and there are no changes to her therapy. The pharmacist adapts the prescription by adding the missing strength

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Practice Examples

Example 3.1 Changing Formulation The pharmacist receives a new prescription for amoxicillin 500 mg capsule tid x 5 days for Ms. MS, a 10 year old, 37.5 kg female patient. Upon discussion with the MS’s mother, the pharmacist learns that the girl has acute otitis media, has trouble swallowing pills and usually favours liquid formulations. The pharmacist adapts the prescription to a liquid suspension

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Practice Examples

Example 3.2 Changing Dosage and Regimen It is a Saturday and the pharmacist receives a prescription from Mr. SC for Symbicort 200 µg 1 inhalation bid which has been the patient’s dose for the past 2 years. Mr. SC explains that his regular physician was away on vacation for the past 3 weeks, and that he went to a walk-in clinic 4 days ago for the Symbicort prescription. Mr. SC also indicated that for the past 2 days, he has noticed an increased need for his salbutamol. The family physician will be returning on Monday and he has already made an appointment to see her that day. The pharmacist increases the Symbicort dose

10/11/2012 10/11/2012

increased dose of Symbicort to 200ug 2 inh bid X 2 days until sees physician for maintenance/reliever therapy

Symbicort 200 ug i inhalation bid X 1 inhaler

Dr. X 4

XXX-XXX-XXXX

- chronic asthma, stable dose X 2 years - symptoms of worsening asthma - increased need for salbutamol for the past 2 days (< 8 puffs/day)

- patient will be seeing family physician in 2 days for regular visit - counselled patient to visit walk-in clinic/ER if worsening signs of asthma - will follow-up with patient on Monday

4 Dr. X and Dr. Y 10/11/2012 XXX-XXX-XXXX

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Practice Examples

Example 3.3 Changing Dosage Mrs. MM is a 70 y.o. woman who is a new patient in a long-term care home where the pharmacist regularly participates as a member of the health care team. Her current medications include glyburide 2.5mg bid, metformin 500mg tid, bisoprolol 5 mg daily, ramipril 5 mg daily, and rosuvastatin 10 mg daily. Her main medical conditions include DM type 2 and hypertension. Her hypertension is currently well controlled. Mrs. MM started therapy with glyburide 3 weeks ago since her HbA1c had increased to 8.0% while on metformin monotherapy. Mrs. MM has had 2 episodes of hypoglycemia during the past 2 weeks and has a fasting blood glucose (FBG) 4.0 mmol/L. The pharmacist decreases the glyburide dose

10/11/2012

XXXXXXXX 09/19/2012

decreased glyburide dose to 2.5mg daily

Glyburide 2.5 mg bid standing order

Dr. X 4

XXX-XXX-XXXX

- patient experiencing signs and symptoms of hypoglycemia X2, fasting blood glucose of 4.0 - in elderly patients the initial dose of a sulfonylurea should generally be 50% of usual initial dose

- counselled patient: on new dosage of glyburide and to contact pharmacist or nurse if continued s/s of hypoglycemia - monitor fasting and post-prandial blood glucose levels over the next 2 weeks - follow-up HbA1c required in 3-4 months

4 Dr. X 10/11/2012 Note in Patient Chart

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Practice Examples

Example 3.4 Changing Dosage and Regimen Mrs. AF is a 85 y.o. woman who is in your office today for a medication review. Her current medications include warfarin 3 mg daily, bisoprolol 5 mg daily, ramipril 5 mg daily, rosuvastatin 10 mg daily, omega 369 300 mg cap daily, acetaminophen XS prn, and Sulfatrim DS 1 tab bid. Her main medical conditions include atrial fibrillation and hypertension (both controlled with medications). Her warfarin dose has been stable for the most part x 2 years. She has INR monitored q4 weeks in a lab. Mrs. AF has recently been dealing with recurrent UTIs and has been on and off sulfatrim for over a month. She is on her last course now with 2 days left. She just had her INR measured and current reading (yesterday) is 4.0. (Based on indication of atrial fibrillation, INR goal range = 2.0-3.0). The last prescription for warfarin was filled at this pharmacy and was for a 6 month supply. The pharmacist decreases the warfarin dose

10/11/2012

XXXXXXXX 09/01/2012

decrease in warfarin dose to 2.5mg daily X 5 days

Warfarin 3 mg daily X 6 months

Dr. X XXX-XXX-XXXX

4

- current INR of 4.0 (INR goal range = 2.0-3.0) - Sulfatrim interacts with warfarin, finished in 2 days but takes 3-5 days for INR to adjust

- counselled patient: on new dosage for warfarin and to contact pharmacist or physician if patient continues to experience s/s of increased bleeding (i.e. bruising or has nose bleeds, blood in stool etc.) - repeat INR required in 5 days, then weekly until INR stabilized in goal range

4 Dr. X 10/11/2012 XXX-XXX-XXXX

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Practice Examples 4. Performing a Procedure on the Tissue Below the Dermis for Education and Chronic Disease Monitoring Example 4.0 Mrs. MM is a 50 y.o. woman who is picking up a refill of her metformin and glyburide and asks if the pharmacist can assist her in monitoring her diabetes as she isn’t sure when and how often she should be testing. Her current medications include glyburide 2.5 mg bid, metformin 500 mg tid, bisoprolol 5 mg daily, ramipril 5 mg daily, rosuvastatin 10 mg daily, and acetaminophen XS prn. Her main medical conditions include DM type 2 and hypertension. The patient was diagnosed with DM type 2 6 months ago. Her physician recently added glyburide (about 2 months ago) because the blood work he did still showed her blood glucose levels were high but she doesn’t remember further details. Her hypertension is currently well controlled. She currently tests her blood glucose once a month and doesn’t record her readings. She tells the pharmacist she thinks her reading was around 9.0 or something like that but can’t remember if it was before or after eating. After further discussion about why the patient doesn’t test more often the pharmacist learns that she finds testing painful and is afraid to do it more often. The patient brought in their glucometer to show the pharmacist which one she is using.  he pharmacist demonstrates how to correctly use the glucometer and lancet T and documents the following in the patient’s profile:

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Practice Examples 5. A  dministering a Substance by Injection or Inhalation for the Purpose of Patient Education and Demonstration Example 5.0 Mrs. FS presents a prescription for Lantus 10 units qhs. The pharmacist learns that Mrs. FS has DM type 2, and that this will be her first time using insulin. She has an appointment with a diabetes clinic in 2 weeks, but is very nervous about injecting her insulin prior to this appointment. The pharmacist explains that he can administer the insulin for her at the pharmacy to show her how to properly perform the injection. The pharmacist ensures there are no contraindications to therapy with Lantus, and he brings Mrs. FS to a private counselling area to administer the injection.  he pharmacist performs the insulin injection for the purpose of patient education and T demonstration and documents the following:

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Regulation

Appendix 2: Regulation ONTARIO REGULATION 302/12 made under the PHARMACY ACT, 1991 Made: August 30, 2012 Approved: September 26, 2012 Filed: October 1, 2012 Published on e-Laws: October 1, 2012 Printed in The Ontario Gazette: October 20, 2012 Amending O. Reg. 202/94 (GENERAL) Note: Ontario Regulation 202/94 has previously been amended. For the legislative history of the Regulation, see the Table of Consolidated Regulations – Detailed Legislative History at www.e-Laws.gov.on.ca. 1. Ontario Regulation 202/94 is amended by adding the following Part: PART VII.3 CONTROLLED ACTS Interpretation

31.

In this Part, “adapt” means to change a patient’s prescription respecting, (a) the dose of the prescribed drug, (b) the dosage form of the prescribed drug, (c) the directions for use of the prescribed drug, or (d) the route of administration for taking the prescribed drug, but does not include therapeutic substitution; “Part A pharmacist” means a member who holds a certificate of registration as a pharmacist and who is listed in Part A of the register;

“prescriber” means a person who is authorized under the laws of a province or territory of Canada to give a prescription within the scope of his or her practice of a health profession; “prescription” means a direction from a prescriber directing the dispensing of a drug or mixture of drugs for a specific patient; “renew” means to provide a patient with a prescription that repeats a prescription previously provided to that patient;

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Regulation

“therapeutic substitution” means the substitution of a drug that contains chemically different active ingredients that are considered to be therapeutically equivalent.

32.

(1) Where the provisions of this Part are inconsistent with a law of Canada respecting prescriptions, including those related to a targeted substance, the law of Canada shall prevail and the provisions of this Part to the extent they are inconsistent with that law shall not apply. (2) Where the provisions of this Part are inconsistent with the provisions of the Narcotics Safety and Awareness Act, 2010, the provisions of that Act shall prevail and the provisions of this Part, to the extent they are inconsistent with that Act, shall not apply. Controlled Acts

33.

A member shall not perform a controlled act under paragraph 2, 3, 4 or 5 of subsection 4 (1) of the Act except in accordance with this Part.

34. (1) For the purposes of paragraph 2 of subsection 4 (1) of the Act, a member referred to in subsection (2) who meets all the requirements in subsection (3) is authorized to perform the following acts: 1. Administering a substance specified in Table 1 to this Regulation by injection to a patient. 2. Administering a substance specified in Table 2 to this Regulation by inhalation to a patient. (2) A Part A pharmacist, an intern or a registered pharmacy student is authorized to perform an act provided for in subsection (1), subject to the terms, conditions and limitations imposed on his or her certificate of registration. (3) A member may only perform an act provided for in subsection (1) if he or she complies with the following: 1. The member may only perform the act for the purpose of patient education and demonstration, and before performing the act, i. must explain that purpose to the patient or his or her authorized agent, and ii. must receive an informed consent from the patient or his or her authorized agent. 2. The member shall ensure that he or she only performs the act in an environment that is clean, safe, private and comfortable for the patient. 3. The member shall ensure that appropriate infection control procedures are in place. 4. The member must possess sufficient knowledge, skill and judgment respecting the substance to be administered, and sufficient understanding of the condition of the patient, to be able to administer the substance safely. 5. The member must consider whether administering a substance by injection or inhalation to the patient is appropriate, given the known risks and benefits to the patient and the safeguards and resources available to safely manage the outcome after administration and any other relevant circumstances. 6. The member must maintain a patient record that includes, i. the name and address of the patient, ii. the name and address of the member, iii. the date the act was performed,

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Regulation iv. the name, strength (where applicable) and quantity of the substance that the member administered to the patient, v. the circumstances relating to the administration of the substance to the patient and any adverse reaction experienced by the patient, and vi.confirmation that an informed consent was given by the patient or his or her authorized agent. (4) For the purposes of paragraph 2 of subsection 4 (1) of the Act, a Part A pharmacist is authorized to administer influenza vaccine by injection to a patient who is five years of age or older, if the Part A pharmacist, (a) administers the vaccine in accordance with Ontario’s Universal Influenza Immunization Program as described on the Ministry’s website; (b) receives an informed consent from the patient or his or her authorized agent; and (c) meets all the requirements in paragraphs 2 to 6 of subsection (3).

35.

(1) For the purposes of paragraph 3 of subsection 4 (1) of the Act, a member referred to in subsection (3) who complies with the other requirements of this section is authorized to prescribe the following specified drugs: 1. Varenicline Tartrate. 2. Bupropion Hydrochloride. (2) A drug mentioned in subsection (1) may only be prescribed by a member for the sole purpose of smoking cessation. (3) A Part A pharmacist, an intern or a registered pharmacy student is authorized to perform the act provided for in subsection (1), subject to the terms, conditions and limitations imposed on his or her certificate of registration. (4) A member may only prescribe a drug under this section if he or she, (a) possesses sufficient knowledge, skill and judgment respecting the drug and the patient’s condition to prescribe the drug for the patient; (b) has considered whether prescribing the drug for the patient is appropriate, given the known risks and benefits of prescribing the drug for the patient and other relevant factors respecting the patient; (c) gives the prescription to the patient or his or her authorized agent; (d) advises the patient or his or her authorized agent, at the time of giving the prescription, that he or she may elect to take it to a pharmacy of his or her choosing for dispensing; (e) notifies the patient’s primary care provider (if any) within a reasonable time, that the member prescribed a drug for the patient and provides details respecting the prescription; and (f) complies with the additional requirements under sections 37 and 38.

36.

(1) For the purposes of paragraph 4 of subsection 4 (1) of the Act, a member referred to in subsection (3) who complies with the other provisions of this section is authorized to perform the following acts: 1. Adapting a patient’s prescription. 2. Renewing a patient’s prescription for the purpose of continuity of care.

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(2) Subsection (1) does not authorize a member referred to in subsection (3) to adapt or renew a prescription for a controlled substance as defined in the Controlled Drugs and Substances Act (Canada) or a drug designated as a monitored drug by the regulations under the Narcotics Safety and Awareness Act, 2010. (3) A Part A pharmacist, an intern or a registered pharmacy student is authorized to perform an act provided for in subsection (1), subject to the terms, conditions and limitations imposed on his or her certificate of registration. (4) A member may only perform an act provided for in subsection (1) if he or she complies with the following: 1. The member must either possess the patient’s prescription to be adapted or renewed or, i. receive a copy of the prescription directly from the pharmacy where the prescription was dispensed to the patient, ii. be satisfied based on verbal confirmation from a pharmacist at the pharmacy where the prescription was dispensed to the patient as to the existence and details of the prescription, or iii. have access to the medical record that contains information about the prescription. 2. If the member is renewing a prescription, he or she must not prescribe a quantity of the drug that exceeds the lesser of, i. the quantity that was originally prescribed, including any refills that were authorized by the prescriber, and ii. a six months’ supply. 3. The member must, within a reasonable time, notify the prescriber identified on the prescription adapted or renewed by the member, as well as the patient’s primary care provider if the member knows that the patient has such a care provider other than the prescriber, providing details about the patient’s prescription, when the member, i. renews a patient’s prescription, or ii. adapts a patient’s prescription, if, in the member’s opinion, A. adapting the prescription is clinically significant in relation to the patient, or B. the notification is necessary to support the patient’s care. 4. At the time that the member adapts or renews the patient’s prescription, the member must advise the patient or his or her authorized agent, i. that he or she is entitled to the prescription, and ii. that he or she may take the prescription to a pharmacy of his or her choosing for dispensing. 5. The member must comply with the additional requirements under sections 37 and 38.

37.

A member who performs an act provided for in section 35 or 36 must ensure that the following information is recorded on the prescription: 1. The name and address of the patient for whom the drug is prescribed. 2. The name, strength (where applicable) and quantity of the prescribed drug. 3. Directions for the use of the drug, including its dose, frequency, route of administration and any special instructions. 4. The name, address, telephone number and College registration number of the member issuing the prescription. 5. The date the prescription was issued by the member.

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Regulation 6. If applicable, reference to the prescription that the member adapted or renewed, including the name and contact details of the original prescriber. 7. The number of refills that the member authorized, if applicable. 8. Any other information required by law.

38.

A member who performs an act under section 35 or 36 must maintain a patient record that includes details of the member’s rationale for his or her decision to act under section 35 or 36 and the following information, if applicable: 1. Reference to, or a copy of, the patient’s prescription that the member renewed or adapted, including the name and contact information of the prescriber. 2. A copy of the prescription that the member gave to the patient or his or her authorized agent under clause 35 (4) (c) or that the member gave to the patient or his or her authorized agent to take to a pharmacy of their choosing under paragraph 4 of subsection 36 (4). 3. A record of the results of laboratory or other tests that the member considered in making the decision to act under section 35 or 36. 4. The date on which the member notified the following persons, as applicable, and the method by which the notification occurred: i. The patient’s primary care provider notified under clause 35 (4) (e) or paragraph 3 of subsection 36 (4). ii. The patient’s prescriber notified under paragraph 3 of subsection 36 (4).

39.

(1) For the purposes of paragraph 5 of subsection 4 (1) of the Act, a member referred to in subsection (2) who meets all the requirements in subsection (4) is authorized to perform the act of piercing a patient’s dermis with a lancet-type device to obtain blood. (2) A member who is a Part A pharmacist, an intern, a registered pharmacy student or a pharmacy technician is authorized to perform the act provided for in subsection (1), subject to the terms, conditions and limitations imposed on his or her certificate of registration. (3) A pharmacy technician shall not perform the act provided for in subsection (1) unless, (a) a Part A pharmacist is physically present on the premises at the time when the pharmacy technician performs the act; and (b) the pharmacy technician is under the direction of a Part A pharmacist at the time when the pharmacy technician performs the act.

(4) A member may only perform the act provided for in subsection (1) if he or she complies with the following: 1. The member may only perform the act for the purpose of demonstrating the appropriate use of lancet-type devices for the patient’s self care and education or for the patient’s self monitoring of his or her chronic disease, and before performing the act, i. shall explain that purpose to the patient or his or her authorized agent, and ii. shall receive an informed consent from the patient or his or her authorized agent. 2. The member shall ensure that he or she only performs the act in an environment that is clean, safe, private and comfortable for the patient. 3. The member shall ensure that appropriate infection control procedures are in place. 4. The member must possess the knowledge, skill and judgment respecting the performance of the act and understand the condition of the patient, to perform it safely and effectively.

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Regulation 5. The member must consider whether performing the act on the patient is appropriate, given the known risks and benefits to the patient and the safeguards and resources available to safely manage the outcome and any other relevant circumstances. 6. The member must maintain a patient record that includes, i. the name and address of the patient and the member, ii. the date the act was performed, and iii. confirmation that an informed consent was given by the patient or his or her authorized agent.

2. The Regulation is amended by adding the following Tables:

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Roles and Responsibilities

Appendix 3: Roles and Responsibilities The Pharmacy Act defines the scope of pharmacy practice for the profession as a whole; however, an individual member’s scope of practice is enabled according to the terms, conditions, and limitations on his or her certificate of registration.

Part A Pharmacist A Part A pharmacist is permitted to independently practice the full expanded scope without additional training, with the exception of the administration of injections. The pharmacist is required to complete an injection training program approved by the College, including valid certification in CPR and First Aid (equivalent of the Red Cross Standard First Aid with CPR “C” plus AED Course level). The administration of the influenza vaccine is limited to pharmacies approved by public health in the context of the Universal Influenza Immunization Program (UIIP). Only pharmacists who have completed and registered approved injection training will be permitted to supervise students and interns in the administration of injections for the purpose of patient education and demonstration.

Registered Pharmacy Student A registered pharmacy student is engaged in attaining education and training in an approved program.

Role and Responsibilities In order for a registered pharmacy student to engage in the practice of pharmacy they must: • Remain active in the program • Be under direct supervision* of a pharmacist (or other regulated health professional if approved by the education program) • Only perform the controlled acts under the direct supervision of a pharmacist. A registered student cannot supervise a pharmacy or delegate or accept delegation of a controlled act.

Intern An intern is a graduate of an approved program.

Role and Responsibilities An intern: • Shall only engage in practice when under direct supervision* of a pharmacist in an accredited pharmacy or under supervision of a pharmacist in all other cases; • Shall not supervise a pharmacy; • Shall not delegate a controlled act.

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Roles and Responsibilities Pharmacy Technician A pharmacy technician has successfully completed education and training either through a bridging process or an accredited program.

Role and Responsibilities As regulated health professionals, pharmacy technicians work collaboratively with pharmacists, and under their direction or supervision. The pharmacy technician undertakes specific technical duties to enhance the service provided to patients including alerting the pharmacist to discrepancies in the accuracy of prescriptions and performing a final technical check for product release. They cannot supervise a pharmacy or delegate a controlled act. Under this new regulation, a pharmacy technician can perform a procedure on tissue below the dermis under the supervision of a Part A pharmacist who is physically present on the premises at the time the technician performs the act.

Expanded Scope: By Membership Class Members will have different roles and responsibilities in implementing the expanded scope of practice according to their status. For example, only a Part A pharmacist is permitted to administer an influenza vaccine in a pharmacy approved to administer the vaccine in accordance with Ontario’s Universal Influenza Immunization Program. The table below provides additional clarity on the ability of a member to perform the controlled acts associated with the new scope of practice.

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Definitions

Appendix 4: Definitions Chronic and Long-Term Condition: A chronic and long-term condition requires ongoing management through medication and/or therapy. While there is no definitive list of long term conditions, conditions such as diabetes, asthma, coronary heart disease, chronic obstructive pulmonary disease, and mental health issues are all regarded as long term conditions. Health Information Custodian: A health information custodian (HIC) is a person or organization that has custody or control of personal health information. A health information custodian includes doctors, other health care practitioners, hospitals, and longterm care facilities. It also includes health care clinics, laboratories, pharmacies, the Ministry of Health and Long-Term Care, and other health-related organizations. Medication Therapy Management (MTM): The term used to describe a group of services that, when taken together, optimizes therapeutic outcomes for individual patients utilizing a member’s unique knowledge and experience. MTM services may include, but are not limited to, the following: 1. Performing or obtaining a patient assessment including a comprehensive medical history and medication review; 2. Identifying, resolving, or managing actual and potential drug therapy problems in collaboration with the patient and other health care professionals; 3. Formulating a medication treatment plan; 4. Selecting, initiating, and adapting prescriptions; and, administering injections and inhalations; 5. Monitoring and evaluating the patient’s response to therapy, including safety and effectiveness; 6. Providing follow-up, including referring to another health professional as required; 7. Documenting the care delivered and communicating with the patient’s primary health care providers; 8. Providing education and training to the patient to enhance patient understanding and appropriate use of medication; 9. Providing information, support services and resources designed to enhance patient adherence with therapeutic regimens; and 10. Coordinating and integrating MTM services within the broader health care management services being provided to the patient. Patient Record: A patient record is a complete reference of all documentation related to the care of a patient including the patient profile. The record includes the patient profile, scanned copy of the original prescription, prescription information, dispensing record of all prescriptions (new and refill) with pharmacist/technician signature and any documentation or information about the patient, including notes related to the member’s critical thinking, judgment, recommendations and interventions, as well as discussions between members, other health care providers, and patients, consent forms, and any other records or documents essential for continuity of care.

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Definitions Record Keeping: All records and documents produced by members in the context of patient care and through the operation of an accredited pharmacy must be kept according to the Standards of Practice and as required by legislation and regulation, both provincial and federal The Documentation and Record Retention, Disclosure, and Disposal Guidelines provide direction for members in this area. Self-administration: The process of a person administering a substance to his or her self. In the context of this manual, self-administration includes circumstances where a parent or caregiver administers a substance to another person.

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