A Step Forward in Cancer Patient Care:

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Madlyn Lane
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1 Hong Kong Pharmacy Conference 2018 A Step Forward in Cancer Patient Care: The Experience of Oncology Pharmacist-Managed Trastuzumab Clinic in Queen Mary Hospital Amy Yuen Clinical Pharmacist

2 24 Oct South China Morning Post

3 Source: Hong Kong Cancer Registry, Hospital Authority 2017

4 Breast Cancer subtypes 1. HR: Hormonal Status (Estrogen receptor/ Progesterone receptor) 2. HER2 Status

5 Breast Cancer subtypes HER2 + Cases: ~21% Source: Hong Kong Breast Cancer Registry Report No

6 Management Overview Early Stages I-IIa Surgery + _ Chemo/Target RT Hormone Locally advanced IIb III Chemo/Target Surgery RT Hormone Metastatic IV Chemo/Target Hormone+ _ Surgery RT

7 Treatment Options Chemotherapy for Ca Breast - Neo-adjuvant Treatment Chemo given before surgery and/or radiation Shrink the tumor so it can be removed with less extensive surgery - Adjuvant Treatment Chemo given after surgery Eradicate microscopic foci of cancer cells to reduce recurrence - Palliative Treatment For metastatic cancer Relieve pain or control the symptoms

8 Treatment Options Chemotherapy Backbone Anthracycline + Taxanes + Targeted agents (if HER2-positive)

9 HER2 targeted agents Treatment options Trastuzumab 1 st indication 1998 Lapatinib Pertuzumab TDM-1 Tripathy, et al BMC cancer.

10 Treatment Options HER2+ Breast Cancer: Trastuzumab for 1 year in adjuvant setting (Category 1 recommendation)

11 More Breast Cancer patients More new drugs available Any new opportunities for Oncology Pharmacists?

12 Current Roles of Pharmacist Established Oncology Pharmacy Services in QMH 1 st cycle Chemotherapy/ Targeted Therapy Consultation Chemotherapy Protocols Verification Guidelines/ Protocols Development Drug Information Enquiry

13 Service Gap 1. Increasing cancer patient population 2. Long patient waiting time 3. Heavy workload for Oncologists

14 Why NOT Pharmacists take the initiative to help?

15 Pharmacist Clinic?

Experience in QMH Pharmacist-managed Trastuzumab Clinic - Established in Jan 2016 - Objectives: To relieve Clinical Oncologist s workload To optimize patient pharmaceutical care by oncologist and

16 Experience in QMH Pharmacist-managed Trastuzumab Clinic - Established in Jan Objectives: To relieve Clinical Oncologist s workload To optimize patient pharmaceutical care by oncologist and oncology pharmacist multidisciplinary approach To reduce patients waiting time for Trastuzumab administration - 2 sessions/week (every Tue and Fri AM) - Charged consultation (Same as doctor s appointment) - Target: HER2 +ve Ca Breast patients on adjuvant maintenance Trastuzumab

17 Experience in QMH Standard Operation Protocol - Drafted in collaboration with oncologists - Listed responsibilities of oncology pharmacist - Standard procedure and documentation for consultation - Predefined criteria for referral to oncologist

18 Experience in QMH WHY target patients on adjuvant Trastuzumab? 1. Relatively long treatment duration (Total 1 year) with frequent follow-ups 2. Relatively stable patient characteristics 3. Increasing number of breast cancer patients on Trastuzumab

19 Consultation Schedule Previous Schedule New Schedule Cycle 1 Cycle 1 Cycle 2 Cycle 2 Cycle 3 Cycle 3 Cycle 4 Cycle 4 Oncologist Pharmacist Cycle 5 Cycle 5

20 Pharmacist Consultation Patient Education Referral Pharmacist Consultation Assessment Documentation

21 Pharmacist Consultation Patient Education - Treatment schedule and the rationale of Trastuzumab and hormonal therapy (if applicable) - Common side-effects and their management - Red flags for severe complications Assessment - Patient s latest medication profile - Potential drug-drug or drug-food interactions - Patient s drug adherence (Hormonal therapy) - Adverse reaction(s) from trastuzumab and hormonal therapy (if any) - Patient s cardiac function (LVEF)

22 Pharmacist Consultation Documentation - Electronic consultation note in the Clinical Management System (CMS) - Written assessment form (to be kept in patients oncology folder)

23 Assessment Form

Pharmacist Consultation Referral to Oncologists - Refer patients to oncologists for any unusual symptoms or the following conditions: Require prescription of medications for side effects

24 Pharmacist Consultation Referral to Oncologists - Refer patients to oncologists for any unusual symptoms or the following conditions: Require prescription of medications for side effects Unsatisfactory cardiac assessment results e.g. LVEF< 50%, LVEF drop 10% Vs baseline etc. Abnormal laboratory results Infusion reactions Severe or unusual side effects from the concurrent hormonal therapy Lymphedema Severe skin reactions from radiotherapy

25 Multidisciplinary Support Oncologists Support in early preparation phase e.g. Provide comments in SOP, Arrange consultation shadowing session for pharmacist Refer eligible patients to Pharmacist Clinic Manage patients with specific concerns identified during Pharmacist consultation Nurses Facilitate the referral logistics e.g. Arrange proper appointment schedule

26 Multidisciplinary Support Referral Logistics

27 Current Data Experience in QMH Number of Treatment Delay prevented (=Total Number of oncologists consultation saved) Number of consultations Number of referrals Number of Interventions 19 10

28 Experience in QMH Reasons for referral to oncologists Reasons Drug request e.g. mouthwash, sleeping pills, cough medication, loperamide Number 8 Cardiac symptoms Edema, mild chest pain, SOB LVEF drop > 10% Skin reaction from RT 3 Dosage adjustment 3 Visual changes 2 Other non-specific symptoms 2 6 4

29 Experience in QMH Types of Interventions Types of Interventions To Oncologists MUGA booking Trastuzumab dose adjustment (due to weight changes) To Patients (Medication related issues) Compliance issue to regular medication Compliance issue to hormonal therapy Drug-food interaction (Tamoxifen and grapefruit) Advise patients on over the counter medications

30 Experience in QMH Intervention Sharing Ms LMK, 67yo Female Diagnosis: Ca R Breast (ER8/8, PR4/8, Her2 score 3) Treatment Plan: Adj chemo TTCH x 6 (From 27/1/2016) Trastuzumab for total of 1 year Adj Letrozole for at least 5 yrs and RT to R breast Baseline MUGA: LVEF 68% (normal range) (27/1/2016) Pharmacist-managed Trastuzumab Clinic Maintenance Trastuzumab cycle 9 (19/7/2016) Last MUGA: 63% (28/4/2016) NO following MUGA appointment

31 Experience in QMH Intervention Sharing Trastuzumab-related cardiotoxicity Increased risk for congestive heart failure (NYHA Class II- IV) or asymptomatic cardiac dysfunction ( LVEF) Not dose or duration-related Withdrawal at early stages of cardiotoxicity may reverse the effect

32 Trastuzumab-associated Cardiomyopathy Assessment and monitoring recommendations Baseline cardiac assessment - History and physical examination - LVEF by echocardiogram or multigated acquisition scanning (MUGA) scan During Trastuzumab therapy - Cardiac assessments every 3 months After discontinuation - Cardiac assessments every 6 months until 24 months from the last administration of Herceptin MUGA Booking (In-house) Recommended LVEF monitoring at 0 month (baseline), 3, 6, 9 and 18 months. Additional scans be performed if clinically indicated

33 Trastuzumab-associated Cardiomyopathy Intervention Sharing - Trastuzumab-related cardiotoxicity Treatment suspension/discontinuation LVEF absolute drops 10% from baseline + LVEF 50% Suspend Trastuzumab and repeat LVEF assessment ~ 3 weeks LVEF has not improved / declined further/ symptomatic CHF Consider discontinue Trastuzumab

34 Trastuzumab-associated Cardiomyopathy Pharmacist Interventions 1. Review patient s latest LVEF result 2. Compare against baseline and last result Any alerting results e.g. LVEF< 50%, LVEF drop 10% Vs baseline? 3. Check for next MUGA appointment date Reminders to oncologist (CMS and in patient s folder) for booking MUGA if no appointment is found

Experience in QMH Patients waiting time estimation (Time of attendance - Actual time of Trastuzumab administration) Data from January to December 2016-2 groups : Control Intervention Clinical

35 Experience in QMH Patients waiting time estimation (Time of attendance - Actual time of Trastuzumab administration) Data from January to December groups : Control Intervention Clinical Oncologist Appointment Group Pharmacist Appointment Group - 40 appointment data from each group collected - Mean waiting time Control: 306 minutes Intervention: 183 minutes Difference: 123 minutes (P < , 95% CI: 91.7 to 154.3)

36 Patients feedback Experience in QMH - Patient satisfaction survey questionnaire for attended patients - 4 simple questions (5-point scale) - Knowledge gain about treatment - Satisfaction

37 Experience in QMH Patients feedback - 40 questionnaires received from Majority of patients agreed that Pharmacist Clinic can improve their knowledge about their treatment - Median satisfactory score: 4 out of % interviewees agree that Pharmacist Clinics can be extended to other oncology patients

38 Patients feedback Experience in QMH

39 Conclusions Pharmacist-managed Trastuzumab Clinic has: Demonstrated a successful model in multidisciplinary care for breast cancer patients Relieved Clinical Oncologist s workload Optimized pharmaceutical care for patients by enhancing patients knowledge on their treatment Reduced patients waiting time for Trastuzumab administration

40 Future Direction?

41 Thank You!

Herceptin SC (Subcutaneous Trastuzumab)

Herceptin SC (Subcutaneous Trastuzumab) DRUG ADMINISTRATION SCHEDULE Day Drug Dose Route Rate 1 Herceptin SC (trastuzumab) 600mg S/C 2 to 5 mins *PRECAUTION: In order to reduce the risk of medication errors it is recommended that all trastuzumab