MEDICAL DAY CARE CLINIC SCIG AND C1 INH HOME INFUSION REFERRAL *MSXX*

MSXX106220A New: Dec 10/14 Page: 1 of 2

FAX to JPOCSC Central Intake (604-953-9701)

PATIENT INFORMATION:

Patient's Name: Gender: Last First Middle Date of Birth: // PHN: Insurance: (DD/MM/YYYY) Address: Street City Province Postal Code Contact Method Primary: Alternate:

REFERRAL INFORMATION:

Referring Health Care Provider: Priority:  Routine  Urgent Name: Title: Source: Date of Referral: MSP #: Phone: Fax:

Reason for Referral:

Medical Reason for Urgency:

Relevant Medical History:

Isolation precautions  Airborne Contact  Droplet

Referral Clinic: SCIG and C1 INH Home Infusion

Referring Health Care Provider Signature: Date:

This facsimile is directed in confidence and is intended for use by the individual or entity to which it is it specifically addressed. Any other distribution, copy, or disclosure is strictly prohibited. The contents of this facsimile may also be subject to privilege and all rights to that privilege are expressly claimed and not waived. If you have received this facsimile in error, please notify us immediately by telephone. Thank you for your co-operation. MEDICAL DAY CARE CLINIC SCIG AND C1 INH HOME INFUSION REFERRAL *MSXX*

MSXX106220A New: Dec. 10/14 Page: 2 of 2 FAX to JPOCSC Central Intake (604-953-9701) SCIG Home Infusion Medical history Primary diagnosis: Secondary diagnosis: Please indicate the following as appropriate: medical history letter(s) laboratory examination results current informed consent for blood transfusion Name of previous SCIG product if any: Current IVIG dose: g/ weeks IgA level: date: Platelet count: date: IgG level: trough date: Peak date: IgG subclasses (if available): Allergy: : Additional comments: Priority level (select applicable) 1. no venous access, adverse reactions 2. inability to maintain stable IgG levels, difficulty traveling for infusions 3. social: work, family, school, travel (vacation) 4. elective C1 INH (Inhibitor) home infusion Medical history Primary diagnosis: Secondary diagnosis: Please indicate the following as appropriate: Have previously used C1 inhibitor product: medical history letter(s) Yes No laboratory examination results If yes: current informed consent for blood transfusion Name of product: Current C1 inhibitor dose: u/kg Length of time on product: Frequency: or as required Adverse reactions: C1 INH quantitative level: date: Normal value for laboratory: C1 INH functional level: (if quantitative level not available) Normal value for laboratory: date: C4 date: Platelet count date: Allergy: : Additional comments: Priority level (select applicable) 1. frequent/severe attacks/delay in therapy 4. adverse reaction or contraindication to other therapy 2. difficulty traveling to hospital to obtain infusion 5. social: work, family, school, travel (vacation) 3. pregnant/breast feeding 6. elective /desire greater convenience

This facsimile is directed in confidence and is intended for use by the individual or entity to which it is it specifically addressed. Any other distribution, copy, or disclosure is strictly prohibited. The contents of this facsimile may also be subject to privilege and all rights to that privilege are expressly claimed and not waived. If you have received this facsimile in error, please notify us immediately by telephone. Thank you for your co-operation. PATIENT REFERRAL Subcutaneous Immune (SCIG) Home Infusion Program *MSXX *

Form ID: MSXX105216A Rev: Mar 01/13 Page: 1 of 1

PLEASE FAX FORM TO: 604-582-3742 WE WILL CONTACT PATIENT FOR APPOINTMENT

Patient Information

Patient Name: DOB: PHN:

Address: City: Postal Code:

Phone: Home: Work: Cellular:

Email address:

Emergency Contact: Name: Phone:

Allergies: NKA List:

Medical History/ Risk Factors Instruction for Referring Physician: Please fax applicable documents listed below: • medical history letter(s) • laboratory examination results • current Informed Consent for Blood Transfusion

Primary Diagnosis:

Secondary Diagnosis:

Current IVIG dose: g/weeks Use of previous SCIG product:

IgA level: Date: Platelet count: Date: Hct: Date:

IgG level: Trough Date: Peak: Date:

Subclasses (if available) Response to immunization:

Medications:

Additional History: See attachment

Priority Level (select applicable)

1. No venous access, adverse reactions 3. Social: work, family, or school related, travel (vacation)

2. Inability to maintain IgG levels, difficulty traveling for infusions 4. Elective

Referring Physician

Physician Name (print): MSP #. Date:

Address: City: Postal Code:

Phone: Office: Cell: Email: PATIENT REFERRAL Subcutaneous Immune Globulin (SCIG) Home Infusion Program

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Enrollment Criteria

1. The patient must have a confirmed diagnosis of (reduced total IgG or IgG subclasses and/or inadequate response to immunization) with recurrent bacterial infection. Although any hypogammaglobulinemic patient who requires IgG replacement may be a candidate for subcutaneous home infusion, this method may be particularly appealing or useful for patients who: • experience adverse events during or immediately after intravenous immune globulin (IVIG) infusion: • have peripheral venous access problems; • desire greater convenience and/or independence from hospital IV administration.

2. The patient or caregiver who will be infusing the patient must be capable of being trained to administer SCIG safely and accurately in the home setting. When considering which patients will be good candidates, attention should be given to a patient's/caregiver's: • ability to read and follow instructions; • ability to learn; • self-motivation; • probable compliance; • physical limitations (especially for manual dexterity).

3. The patient or caregiver must be trained to administer SCIG, as outlined below. This training must include a minimum of three sessions of supervised SCIG self-injections.

4. The patient (or guardian) must be made aware that SCIG is a blood product with associated risks, that infusion in the home is associated with additional risk, and must provide written informed consent to SCIG home infusion

5. The patient (or guardian) must agree in writing to complete and submit infusion logs.

6. The patient's home infusion setting must have a working telephone and should have access to rapidly available emergency assistance. A physician must be available by telephone for immediate consultations should urgent medical care be required.

7. For patients under age 19, and for all patients during their first month of SCIG therapy, a competent adult must be available in the home infusion setting to assist the patient for the entire period of the infusion and must remain available to the patient for at least 60 minutes thereafter. For patients aged 19 and older, the requirement for another competent adult to be in attendance during the procedure and for at least 60 minutes thereafter should be reviewed following the first month of SCIG home infusion. If, after the first month, the patient has experienced no serious adverse events, it may be sufficient to have another competent adult available via telephone. Program staff must emphasize the product risks and work with the patient/caregiver to develop a plan for whom, how and under what circumstances the patient/caregiver would contact another competent adult, the SCIG Clinic nurse, ordering physician, general practitioner, or emergency services based on an algorithm of escalating risk.

8. The patient's general practitioner, emergency department staff and/or community health nurse (in rural communities) must be informed both before and after the training period, so that they are aware there is a SCIG home infusion patient in their community and can ensure that appropriate services are readily available in the event the patient has a problem.

Contraindications: 1 . SCIG is contraindicated in individuals with a history of anaphylactic or severe systemic response to immune globulin preparations, and in persons with selective immunoglobulin A (IgA) deficiency (serum Ig <0.05 g/L) who have known antibody against IgA.

2. Caution should be used in patients with platelet disorders or other bleeding tendencies.

3. The safety and efficacy of SCIG has not been studied in patients <2 years old. SMH/JPOCSC Pre-Printed Orders and Patient Enrolment Notification for Subcutaneous Immune Globulin (SCIG) Home Infusion Program *DRDO*

Form ID: DRDO105213B Rev: Jan 02, 2020 Page: 1 of 1 DRUG & FOOD ALLERGIES

 Mandatory  Optional: Prescriber check () to initiate, cross out and initial any orders not indicated. Physician's Order for Subcutaneous Immune Globulin (SCIG) Date: Informed consent completed Patient's Diagnosis: SCIG brand name:

Concentration 20% = 0.2 g/mL 16.5% = 0.165 g/mL Other Option #1: Converting Intravenous Immune Globulin (IVIG) dose to SCIG dose

IVIG dosage (grams) ÷ previous treatment interval (weeks) = IVIG dose grams/week

IVIG dose grams/week ÷ grams/mL (g/mL) = mL/week SCIG Option #2: Ordering SCIG usual adult dosage is 0.1 g/kg/week.

Patient's weight kg x dosage 0.1 g/kg/week = g/week SCIG SCIG dosage g/week ÷ g/mL = mL/week SCIG

Option #3: Weekly SCIG mL/week SClG

Date (dd/mm/yyyy): Time: Prescriber Signature: Printed Name and College ID:

SCIG Home Infusion Program Notification for Transfusion Medicine Service (TMS)

Hospital/TMS name: TMS/Lab telephone:

This is the first notification for this patient: Yes No TMS/Lab fax:

This is an order change: Yes No Product will be required: every month every 3 months

Product required: x 5 mL vials x 10 mL vials x 20 mL vials x mL vials

x 40 mL vials x 50 mL vials x mL vials x mL vials

Clinic RN Signature: Order expired on (date): SCIG Clinic will fax TMS/Lab notification of product pickup approximately two weeks before the required date. SCIG Clinic contact: 604-363-7373 Fax: 604-582-3742 TMS Use only

Reviewed by: Notes:

Patient's TMS computer/record updated Order expire date: SMH/JPOCSC Pre-Printed Orders and Patient Enrolment Notification for Subcutaneous Immune Globulin (SCIG) Home Infusion Program

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1. The patient must have a confirmed diagnosis for an approved indication for SCIG. Requests for SCIG for non-approved/licensed indications will require approval by a transfusion medicine physician. • Approved indications: Primary Immune Deficiency, Secondary Immune Deficiency as outlined below

2. Patients referred with hypogammaglobulinernia must have a confirmed diagnosis (reduced total IgG or IgG subclasses and/or inadequate response to immunization) with recurrent bacterial infection. Although any hypogammaglobulinernic patient who requires IgG replacement may be a candidate for subcutaneous home infusion, this method may be particularly appealing or useful for patients who: • experience adverse events during or immediately after intravenous immune globulin (IVIG) infusion: • have peripheral venous access problems; • desire greater convenience and/or independence from hospital IV administration.

3. The patient or caregiver who will be infusing the patient must be capable of being trained to administer SCIG safely and accurately in the home setting. When considering which patients will be good candidates, attention should be given to a patient's/caregiver's: • ability to read and follow instructions; • ability to learn; • self-motivation; • probable compliance; • physical limitations (especially for manual dexterity).

4. The patient or caregiver must be trained to administer SCIG, as outlined below. This training must include a minimum of three sessions of supervised SCIG self-injections.

5. The patient (or guardian) must be made aware that SCIG is a blood product with associated risks, that infusion in the home is associated with additional risk, and must provide written informed consent to SCIG home infusion

6. The patient (or guardian) must agree in writing to complete and submit infusion logs.

7. The patient's home infusion setting must have a working telephone and should have access to rapidly available emergency assistance. A physician must be available by telephone for immediate consultations should urgent medical care be required.

8. For patients under age 19, and for all patients during their first month of SCIG therapy, a competent adult must be available in the home infusion setting to assist the patient for the entire period of the infusion and must remain available to the patient for at least 60 minutes thereafter. For patients aged 19 and older, the requirement for another competent adult to be in attendance during the procedure and for at least 60 minutes thereafter should be reviewed following the first month of SCIG home infusion. If, after the first month, the patient has experienced no serious adverse events, it may be sufficient to have another competent adult available via telephone. Program staff must emphasize the product risks and work with the patient/caregiver to develop a plan for whom, how and under what circumstances the patient/caregiver would contact another competent adult, the SCIG Clinic nurse, ordering physician, general practitioner, or emergency services based on an algorithm of escalating risk.

9. The patient's general practitioner, emergency department staff and/or community health nurse (in rural communities) must be informed both before and after the training period, so that they are aware there is a SCIG home infusion patient in their community and can ensure that appropriate services are readily available in the event the patient has a problem.

Contraindications: 1. SCIG is contraindicated in individuals with a history of anaphylactic or severe systemic response to immune globulin preparations, and in persons with selective immunoglobulin A (IgA) deficiency (serum Ig < 0.05 g/L) who have known antibody against IgA.

2. Caution should be used in patients with platelet disorders or other bleeding tendencies.

3. The safety and efficacy of SCIG has not been studied in patients < 2 years old. SMH & JPOCSC Pre-Printed Orders for C1 Esterase Inhibitor and Enrolment Notice – Home Infusion Program *DRDO*

Form ID: DRDO105920B Rev: Oct 10, 2019 Page: 1 of 1 DRUG & FOOD ALLERGIES

 Mandatory  Optional: Prescriber check () to initiate, cross out and initial any orders not indicated.

Physician's Order for C1 Esterase Inhibitor . Patient's Diagnosis: Hereditary . Date: Informed consent completed (proven C1 Esterase Inhibitor deficiency)

Patient weight: kg

Select one of the following options: BERINERT units IV times a week (usual dose BERINERT 20 units per kg) BERINERT units IV as required CINRYZE units IV times a week (usual dose CINRYZE 1000 units twice a week) Other:

C1 Esterase Inhibitor Home Infusion Program Notification for Transfusion Medicine Service (TMS)

Hospital/TMS name: TMS/Lab telephone:

Product will be required for the following: vials BERINERT (500 units per vial) Other: vials BERINERT (1500 units per vial) vials ClNRYZE (500 units per vial) every 1 month every 2 months every 3 months as required

Clinic RN Signature: Order expires on (date):

Home infusion nurse will fax TMS/Lab notification of product pickup approximately two weeks before the required date. TMS use only

Reviewed by: Notes:

Patient's TMS computer/record updated Order expiry date: C1 Esterase Inhibitor ordered from Canadian Blood Services

Date (dd/mm/yyyy) Time Prescriber Signature Printed Name and College ID# SMH & JPOCSC Pre-Printed Orders for C1 Esterase Inhibitor and Enrolment Notice - Home Infusion Program

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Enrolment Criteria

The patient must have a confirmed diagnosis of hereditary angioedema (proven C1 Esterase Inhibitor deficiency) with recurrent attacks of clinically significant angioedema. This method may be particularly appealing or useful for patients who: desire greater convenience and/or independence from hospital ER have difficulty attending the ER due to time and distance; have frequent/severe attacks; are pregnant/breast feeding; have adverse reaction or contraindication to alternative treatments.

The patient or caregiver who will be infusing the patient must be capable of being trained to administer C1 Esterase Inhibitor safely and accurately in the home setting. When considering which patients will be good candidates, attention should be given to a patient's/caregiver's: ability to read and follow instructions, ability to learn, self-motivation, probable compliance, physical limitations (especially for manual dexterity).

Informed consent must be obtained from the patient. The patient (or guardian) must be made aware that C1 Esterase is a blood product with associated risks and that infusion in the home is associated with additional risk.

The patient (or guardian) must sign a Patient Consent & Participation Agreement.

The patient or caregiver must be trained to administer C1 Esterase Inhibitor. This training must include a minimum of two sessions of supervised C1 Esterase Inhibitor or normal saline self-injections.

The patient's home infusion setting must have a working telephone and should have access to emergency assistance. Medical assistance must be available by telephone for immediate consultations should urgent medical care be required.

For patients under age 19, and for all patients during their first month and/or first three C1 Esterase inhibitor home infusions, a competent adult must be available in the home infusion setting to assist the patient for the entire period of the infusion and must remain available to the patient for at least 60 minutes thereafter. For patients aged 19 and older, the requirement for another competent adult to be in attendance during the procedure and for at least 60 minutes thereafter should be reviewed following the first month and/or a minimum of three C1 Esterase inhibitor home infusions. If, after the first month and/or a minimum of three C1 Esterase inhibitor home infusions, the patient has experienced no serious adverse events, it may be sufficient to have another competent adult available via telephone.

Contraindications: • C1 Esterase Inhibitor is contraindicated in individuals with a history of anaphylactic or severe systemic response to C1 Esterase Inhibitor preparations. • Children: The safety and efficacy of C1 Esterase Inhibitor has not been studied in children. • Pregnancy: Animal reproduction studies have not been conducted with C1 Esterase Inhibitor. It is not known whether C1 Esterase Inhibitor can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. C1 Esterase Inhibitor should be given to a pregnant woman only if clearly needed. • Labour and Delivery: The safety and effectiveness of C1 Esterase Inhibitor administration prior to or during labour and delivery have not been established. Use only if clearly needed. • Nursing Mothers: It is not known whether C1 Esterase Inhibitor is excreted in human milk. Because many drugs are excreted in human milk, use only if clearly needed when treating a nursing woman. 27/02/2014 10:49 N' fraserheallh Regional CONSENT FOR HEALTH CARE

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CWXX104852A Rev: June 2011 Page: 1 of 2

PATIENT SURNAME FIRST NAME Other names DOB(d/m/yyyy) CARE CARD #

Section 1: Provider Statement

Details of proposed health care treatment, procedure or treatment plan (print legibly and in full without abbreviations):

I have discussed the proposed health care and re lated risks with the patient or substitute decision-maker who, in my opinion, understood the information provided.

Provider Name (print): ______Signature: ______Date (d/m/yyyy): ____

*Note: Provider refers to the most responsible health care provider proposing and/or performing the health care.

Section 2: Patient or Substitute Decision Maker Consent Please note: You have the right to ask questions and receive answers about your health care. I, -----;--c-:----:------consent to the health care described above. The nature and anticipated (print name) effect of the proposed care, including the significant risks and available alternatives have been explained to me. I am satisfied with and understand the explanations. I also understand that: a. My provider may make use of other health care providers (in cl uding trainees) who may attend and/or assist in my care under the direction of my provider. b. If tissues, body fluids or implants are removed during my care, they may be used for diagnostic examination , education or quality improvement purposes. c. If a health care worker is exposed to my blood or body fluids during my care, my blood will be tested for risk assessment purposes for Hepatitis S, Hepatitis C and HIV. The test results will be confidential and will only be used to treat the health care worker. If positive, the test results will be reported to pub li c health authorities as requ ired by law (Provincial Health Act) and I will be offered treatment. d. If my care includes inserting a medical device, my personal in formation will be shared with the supplier of the device for my safety, and will come under the privacy laws of the co untry where the supplier is located.

Signature: ______Date (d/m/yyyy): ____ o Patient 0 ParenULegal Guardian 0 Substitute Decision Maker- *Note: If signed by Substitute Decision-Maker, complete the Confirmation of Substitute Decision Maker form.

III ~ o Section 3: Administration of Blood Components/Products (if applicable) o Not applicable Ul My provider told me it may be necessary for me to receive blood components or blood prod ucts during my treatment. o Yes, I consent to receive blood co mponents/prod ucts 0 No, I refuse blood components/products*

Signature: Date (d/m/yyyy): ____ o Patient 0 ParenULegal Guardian 0 Substitute Decision Maker- *Note: If consent is refused, the Refusal of Blood Components/Products Administration form must be completed. Regional CONSENT FOR HEALTH CARE Cont'd

Page: 2 of 2

Section 4: Interpreter Declaration I have accurately translated this document and acted as interpreter for the patient or substitute decision maker who told me that he/she understands the explanation and consents as described on page 1 of this form.

Interpreter Name (print): ______Signature: ______Date (d/m/yyyy): ____

Section 5: Telephone Consent

I have discussed the nature and expected effects of the proposed health care, including significant risks and available alternatives with (print name) who is the patient's (state relationship ) , and who has given verbal consent as substitute decision maker.

Provider Name (print): ______Signature: ______Date (d/m/yyyy): ____

Note: Where possible, at the earliest opportunity, the person who granted consent over the phone should sign Section 2 of this form.

Section 6: Certificate of Need for Urgent/Emergency Health Care I certify it is necessary to provide the proposed hea lth care without delay in ord er to save the patient's life, to prevent serious physical or mental harm, or to alleviate severe pain. The patient is, in my opinion, incapable of giving or refusing consent, and has not previously indicated a refusal to consent to this health care. I have been unable to consult with any available substitute decision-maker within a reasonable time in the circumstance and am not aware of an Advance Directive that the patient does not want the proposed hea lth care.

Provider Name (print): ______:-- ___ Signature: ______Date (d/m/yyyy): ____

If practicable, it is recommended a second provider confirm the need for the proposed health care and the patient's incapability.

Provider #2 Name (print): ______Signature: ______Date (d/m/yyyy): ____

Instructions to Providers: 1. To be completed and signed in ink. 2. Nursing staff may obtain the signature of the substitute decision maker following telephone consent as confirmation of the consent decision. Any explanation about the proposed health care is the provider's responsibility. 3. Section 3 to be completed only if applicable. 4. Changes to this form must be initialed and dated by the provider and the patient or substitute decision maker. 5. The original of this form must be placed on the patient's health record .