Safe Practices in Oral Anticancer Medications: Implications for Community Pharmacy

Transcription

1 Safe Practices in Oral Anticancer Medications: Implications for Community Pharmacy Faculty Disclosures Dr. Holle has provided content expertise on patient education materials for Innocrin Pharmaceuticals Inc. investigational drugs Lisa M. Holle, PharmD, BCOP, FHOPA Associate Clinical Professor Learning Objectives At the conclusion of this presentation, participants should be able to: Describe common dispensing and administration challenges with oral anticancer medications Identify potentially significant drug drug interactions with oral anticancer medications Describe proper handling and disposal of oral anticancer medications Oral Cytotoxic Agents 6 Mercaptopurine 1953 Etoposide 1986 Methotrexate 1953 Altretamine 1990 Busulfan 1954 Capecitabine 1998 Chlorambucil 1957 Cyclophosphamide 1999 Melphalan 1964 Temozolomide 1999 Thioguanine 1966 Topetecan 1999 Procarbazine 1969 Fludarabine 2008 Lomustine 1976 Trifluridine/tipiracil 2015 Estramustine 1981 Hormonal Agents Tamoxifen 1977 Flutamide 1989 Anastrozole 1995 Bicalutamide 1995 Nilutamide 1996 Letrozole 1997 Exemestane 2005 Abiraterone 2011 Enzalutamide 2012 Targeted/Biologic Agents Thalidomide 1998 Nilotinib 2007 Regorafenib 2012 Bexarotene 1999 Everolimus 2009 Vismodegib 2012 Imatinib 2001 Pazopanib 2009 Afatanib 2013 Erlotinib 2004 Crizotinib 2011 Dabrafenib 2013 Tretinoin 2004 Ruxolitinib 2011 Trametinib 2012 Lenalidomide 2005 Vandetanib 2011 Pomalidomide 2013 Sorafenib 2005 Vemurafenib 2011 Ibrutinib 2013 Dasatinib 2006 Axitinib 2012 Idelalisib 2014 Sunitinib 2006 Bosutinib 2012 Olaparib 2014 Vorinostat 2006 Cabozantinib 2012 Ceritinib 2014 Lapatinib 2007 Ponatinib 2012 Alecitinib

2 Targeted/Biologic Agents (cont) Cobimetinib 2015 Osimertinib 2015 Sonidegib 2015 Ixazomib 2015 Palbociclib 2015 Venetoclax 2016 Lenvatinib 2015 Panobinostat 2015 Cost of Anticancer Medications Dusetzina SB. JAMA Oncol. 2016;2: Cost of Anticancer Medications Increases in monthly drug costs occur Each year following FDA approval Subsequent indication FDA approval Compendia off label indication Introduction of competitor Cost of Anticancer Medications Medical vs pharmacy benefit coverage Infusion and injectables medical plan Orals pharmacy benefit Patient assistance programs Manufacturer rebates/coupons Foundation Formulary/prior authorization Bennette CS. Health Affairs. 2016;35: Access to Oral Anticancer Agents Pause and Ponder What can you do as a community pharmacist to minimize cost and/or access barriers to oral anticancer medications? Schwartz RN, et al. J Natl Compr Canc Netw. 2010;8:S1 S12. 2

3 Administration 62 yo women with breast cancer Palbociclib 125 mg po daily days 1 21 and letrozole 2.5 mg po daily 75 yo man with prostate cancer Abiraterone 1000 mg (4 x 250 mg) po daily and prednisone 5 mg po BID 43 yo man with colon cancer Capecitabine 1000 mg/m 2 po BID and oxaliplatin 130 mg/m 2 IV q 21 days Adherence 46% 100% Nonadherence Side effects Lack of support Forgetfulness Complex regimens/long duration Consequences Disease progression Reduced quality of life Increased healthcare costs Role of the Community Pharmacist Which of the following is the most important thing a community pharmacist can do to facilitate adherence? a. Provide manufacturer s patient information b. Refer patient to cancer care team c. Determine adherence with each refill d. Fill a pill box with medication Interactions Substrates CYP450 P glycoprotein Breast cancer resistance protein (BRCP) Uridine diphosphate glucuronyltransferase (UGT) Acid suppression Warfarin QTc prolongation Warfarin Interactions Increase INR Decrease INR Affects Anticancer Med Capecitabine Darafenib Regorafenib Ceritinib Enzalutamide Dastatinib Erlotinib Flutamide Gefitinib Imatinib Regorafenib Sorafenib Tamoxifen Vemurfenib Vorinostat Interactions Other anticoagulants Certinib and apixaban Dabigatran and lapatinib Idelalisib and apixiban Idelalisib and rivaroxaban Tamoxifen and letrozole Erlotinib and tobacco 3

4 Food Interactions Take With Food Take on Empty Stomach Alecitinib Venetoclax Abiraterone 6 Mercaptopurine Altretamine Vorinostat Afatanib Melphalan Bexarotene Cabozantanib Methotrexate Bosutinib Ceritinib Nilotinib Capecitabine Chlorambucil Pazopanib Cyclophosphamide Dabrafenib Pomalidomide Exemestane Erlotinib Sonidegib Imatinib Estramustine Sorafenib Palbociclib Etoposide Thalidomide Regorafenib Ixazomib Temozolomide Tretinoin Lapatanib Trametinib Trifluridine/Tipiracil Lomustine Chen B, Holle L. Oral cancer therapy. In: Pham T, Holle L. Cancer Therapy: Prescribing Lexi comp, Food Interactions Calcium estamustine, mercaptopurine Grapefruit and other fruit Bexarotene, bosutinib, cyclophosamide, exemestane, imatinib, regorafenib Panobinostat grapefruit, Seville oranges, pomegranate Olaparib grapefruit, Seville oranges Venclexta grapefruit, Seville oranges, starfruit Fat regorafenib Tyramine containing foods procarbazine Lactose Intolerance Take With Food Alecitinib Cobimetinib Dasatinib Nilotinib Palbociclib Ponatinib Sonidegib Patient Case #1 Interactions KS 62 yo BF with metastatic breast cancer cancer now receiving capecitabine 1000 mg/m 2 PO BID days 1 14 and lapatanib 1250 mg po days Which of the following is correct regarding food interactions with these drugs? a. Capecitabine with food, lapatinib without food b. Capecitabine without food, lapatinib with food c. Both with food d. Both without food Patient Case #1 Interactions KS 62 yo BF with metastatic breast cancer cancer now receiving capecitabine 1000 mg/m 2 PO BID days 1 14 and lapatanib 1250 mg po days What potential drug interactions exist with these drugs? Capecitabine Lapatanib Potential Risks Associated with Exposure to Oral Chemotherapy Handling oral chemotherapy agents during storage, preparation, administration and disposal can results in exposure through Inhalation Ingestion Skin contact/absorption Goodin S, et al. J Oncol Pract. 2011;7:

5 What is a Hazardous? Risk is certainly greatest with drugs causing carcinogenicity but other potential hazards Teratogenicity or other developmental toxicity Reproductive toxicity Organ toxicity at low doses Genotoxicity Structure and toxicity profiles mimicking existing hazardous properties Oral Chemotherapy s: Hazardous? Pregnancy category designation National Institute for Occupational Safety & Health (NIOSH) designation Manufacturer handling recommendations ASHP. Am J Health Syst Pharm : Connor T, et al. NIOSH Publication No :1 15 Oral Chemotherapy: Hazardous s? Oral Chemotherapy: Hazardous s? Abiraterone acetate Pregnancy Category NIOSH Manufacturer Handling Recommendations X Yes Based on its mechanism of action, may harm a developing fetus. Therefore, women who are pregnant or women who may be pregnant should not handle without protection (eg, gloves) Pregnancy Category NIOSH Manufacturer Handling Recommendations Dabrafenib D No* None Erlotinib D Yes None Anastrazole D Yes None Capecitabine D Yes Care should be exercised in handling. Tablets should not be cut or crushed. Procedures for proper handling and disposal should be considered. Any unused product should be disposed of in accordance to local requirements. Several guidelines are published. If contact with skin, wash thoroughly, if contact with mucous membranes, flush thoroughly with water Connor T, et al. NIOSH Publication No :1-15; Zytiga [package insert]. Horsham, PA: Janseen Biotech, Inc; May 2014; Xeloda[package insert]. South San Francisco, CA: Genentech USA, Inc; March Imatinib D Yes Is an antineoplastic product. Follow special handling and disposal procedures. Tablets should not be crushed. Direct contact of crushed tablets with the skin or mucous membranes should be avoided. If such contact occurs, wash thoroughly as outlined in the references. Personnel should avoid exposure to crushed tablets. *Not commercially available at time of NIOSH 2014 publication; 2016 draft publication lists it as hazardous. Connor T, et al. NIOSH Publication No :1-15; Gleevac [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; Jan Oral Chemotherapy: Hazardous s? Pregnancy NIOSH Manufacturer Handling Recommendations Category Lenalidomide X Yes Care should be exercised when handling drug. Do not open/crush capsules. If powder from capsule comes in contact with skin, wash immediately and thoroughly with soap and water. If contact with mucous membranes, flush with water. Procedures for proper handling and disposal should be considered. Several guidelines published Pazopanib D Yes None Regorafenib D No* Dispose of unused tablets in accordance with local requirements (note must discard unused tablets 7 weeks after opening bottle) Connor T, et al. NIOSH Publication No :1-15; Revlimid [package insert]. Summit, NJ: Celgene Corporation; June 2013; Stivarga [package insert]. Whippany, NJ; Bayer HealthCare Pharmaceuticals Inc; At the Community Pharmacy Handling Use current packaging Avoid automatic counting devices Wear personal protective equipment Cutting/crushing/manipulating or administering these tablets/capsules Compounding or administration of oral liquids Storage Separate storage Provide in plastic bag for transport Labeling Clear instructions Hazardous drug label 5

6 Handling Oral Hazardous s (cont) Patients handling Wash hands after administration Use separate pill boxes Swallow medication whole Wash hands after using toilet or if vomiting Caregiver handling Pregnant, breastfeeding or children should not handle drug or waste Wash hands and wear gloves when administering Avoid contact with waste Goodin S, et al. J Oncol Pract. 2011;7:7-12. Hazardous Disposal Incorrect disposal of hazardous drugs Can pollute water and ground Be toxic to plants, animals, humans Dispensed oral chemotherapy is Considered household wastes not institutional waste Managed by local and state environmental agencies, like CT Department of Energy and Environmental Protection and Control Environmental Protection Agency. Available at: Accessed January 21, Oral Chemotherapy: Proper Disposal Guidance The 2013 Updated American Society of Clinical Oncology (ASCO)/Oncology Nursing Society (ONS) Chemotherapy Administration Standards Stress the importance of patient/caregiver education on proper disposal BUT Provide no specifics on proper disposal process 2011 Safe Handling of Oral Chemotherapy International Pharmacy Panel recommend Return wet, damaged, unused, discontinued, or expired drugs to pharmacist or hospital for disposal Neuss MN, et al. J Oncol Pract. 2013;9:5S-13S; Goodin S, et al. J Oncol Pract. 2011;7:7-12. Oral Chemotherapy: Proper Disposal Guidance ASCO s Cancer.Net (a reputable patient education resource) recommends patients Talk with the doctor or pharmacist or read the information the comes with drug about how to properly dispose Never flush oral chemotherapy or put in the trash Return any unused oral chemotherapy to doctor/nurse for disposal Ask healthcare team ahead of time if empty containers or other chemotherapy waste needs to be returned to office or treatment center for disposal Safe storage and disposal of cancer medications. Available at: Accessed January 21, UConn Health: Oral Chemotherapy Disposal Program CT Department of Energy & Environmental Protection and Division of Control who approved disposal program Allows Neag Cancer Center patients receiving oral chemotherapies to dispose of them at UConn Health Other medications, opioids, prescription drugs, over the counter drugs or supplements are not allowed to be disposed in this program UConn Health: Oral Chemotherapy Disposal Disposal Train Personnel Collection Patient Education 6

7 Knowledge Check Questions? You are preparing a capecitabine prescription for dispensing. Which of the following handling instructions is correct? a. Wash hands and use a separate counting tray b. Wash hands, don gloves, and use a separate counting tray c. Wash hands, don gloves, and use an automatic counting machine d. Wash hands and use automatic counting machine 7