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Oral Chemotherapy – Moving Cancer Treatment into Community Pharmacy

Maggie Charpentier, PharmD, BCPS Clinical Associate Professor University of Rhode Island Per-diem pharmacist: Roger Williams Medical Center. Oral Chemotherapy – Moving Cancer Treatment into Community Pharmacy. Goal and Objectives. Goal:

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Oral Chemotherapy – Moving Cancer Treatment into Community Pharmacy

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  1. Maggie Charpentier, PharmD, BCPS Clinical Associate Professor University of Rhode Island Per-diem pharmacist: Roger Williams Medical Center Oral Chemotherapy – Moving Cancer Treatment into Community Pharmacy

  2. Goal and Objectives • Goal: •  Educate pharmacists regarding counseling and safe dispensing of oral chemotherapy in community pharmacy • Objectives: • Review the changing paradigm of cancer treatment –moving to chronic therapy administered in the community • Review potential hazards of dispensing chemotherapy in the pharmacy • Review recommendations to safeguard pharmacy staff when dispensing • Review counseling points for patients and their care givers in safely administering and disposing of chemotherapy • Review counseling of oral chemotherapy

  3. Practice setting-pharmacists only 1. Community pharmacy 2. Outpatient clinic 3. Hospital setting 4. Non – dispensing practice site 5. Other :10

  4. Practice location-pharmacists • In RI or within 20 miles of RI • Outside RI and 20 miles surrounding area :10

  5. How confident are you about your oral chemotherapy knowledge? • Not confident • Somewhat confident • Neutral • Confident • Strongly Confident :15

  6. Does your pharmacy have a counting tray devoted to cytotoxic medications? • Yes • No :10

  7. Do you wear gloves when handling oral cytotoxicchemotherapy ? • Yes • No :10

  8. Do you usually wash hands immediately after handling oral cytotoxicmedications? • Yes • No :10

  9. Do you counsel caregivers on safe handling of cytoxic medication? • Yes • No :10

  10. Do you require a double-check by another person when dispensing oral cytotoxicmedication? • Yes • No :10

  11. Which of the following oral chemotherapy agents is dosed based on Body Surface Area (BSA)? • Sunitinib • Exemastane • temazolamide • I don’t know :15

  12. The wife of a patient calls your pharmacy. He can no longer swallow medications unless they are liquid, or crushed. Her husband is on Temodar. What is your response? • Tell the wife to place in a ziplock bag and hit with a mallot, then rinse into a cup of water to drink • Prepare a liquid formulation in pharmacy by crushing tablets and mixing with simple sugar syrup, giving a 30 day expiration • Call the doctor • I don’t know :30

  13. What counseling point(s) is/are important for a patient receiving chemotherapy that can lower white blood counts? • Call your doctor for any temperature 2 degrees above your normal temperature • If you have symptoms of sore throat, or cough, call the doctor only if accompanied by a fever • Avoid contact with anyone who is ill. • All of the above • I don’t know :20

  14. Counseling for capecitabine (Xeloda®) includes which of the following? • Edema is common • Take within 30 minutes of a meal • Skin rash indicates higher efficacy • All of the above • I don’t know

  15. Which of the following drugs can interact with CYP 3A4 agents? • Erlotinib (Tarceva®) • Sunitinib (Sutent®) • Lapatinib (Tykerb®) • All of the above • I don’t know :15

  16. Which of the following drugs may commonly cause hypertension? • Temodar® • Tarceva® • Sutent® • All of the above • I don’t know :10

  17. Oral Chemotherapy-coming to a pharmacy near you! • Traditionally – chemotherapy was rarely dispensed in the community pharmacy • Little or no data on safe practice • Some agents: • BusulfanCapecitabine • ChlorambucilCyclophosphamide • EtoposideHydroxyurea • LomustineMelphalan • MercaptopurineMethotrexate • Procarbazine Thalidomide • Temozolomide • targeted agents: imatinib, erlotinib, etc • Hormonal agents: tamoxifen, anastrozole

  18. Where are we headed? • Approximately 20-25% of investigational chemotherapy agents are oral • Annual growth: expected to be 30-35% • Patient preference • Advantages to patients • Challenges Hematol Oncol News Issues 2007;6:24-6

  19. Challenges – taken one-by-one • Medication errors • Wrong drug • Wrong dose • Wrong patient • Wrong directions In hospitals – we follow written referenced protocols, verified using several sources, and checked by two pharmacists, technician, nurse, and physician.

  20. Mo Lawsuit alleges [Chain Pharmacy] Error Caused Miscarriage • October 23, 2007 • When Chanda Givens began feeling sick and throwing up about a month into her pregnancy, she wrote it off as morning sickness. • It was only after the suburban St. Louis woman miscarried a month later that she learned the pills that she thought were prenatal vitamins were actually a potent chemotherapy drug that killed her unborn child, according to a lawsuit against [PHARMACY]., whose pharmacy allegedly dispensed the wrong medicine. • Mefford said Givens became pregnant in February. On March 6, she went to an O'Fallon, Mo., [PHARMACY] to fill a prescription for Materna, a prenatal vitamin. • Instead, Mefford said, Givens was given Matulane, a chemotherapy drug for treatment of Hodgkin's disease. The lawsuit states that drug is designed to interfere with cell growth and DNA development. • Givens began feeling nauseous and vomiting soon after taking the drug. Later in March, her doctor warned the baby was not developing properly.

  21. Medication errors documented in oral chemotherapy • Four clinics retrospectively reviewed medication errors in children and adult oncology patients • Occurred in 7.1% of adult clinic visits and 18.8% of pediatric clinic visits were associated with a medication error • Good news, study included all errors, of all the chemotherapy medications reviewed, 1.4% of chemotherapy prescriptions resulted in an error • 7% of errors occurring in adults were during home administration; while 27% of pediatric errors were during home administration J Clin Oncol 2009. 27: 891-96.

  22. Types of errors • Dose adjustments not made based on clinical status changes (drop in neutrophil count, change in organ function) • Orders written for several months • In children, parents made errors in measurement, and administration J Clin Oncol 2009. 27:891-96

  23. Interventions identified to minimize errors • Improved communication • Improved technology • Computer order entry • EMAR • EMR • Drug dose double-checking • Patient education about home medication use • In children: educate parents, color-code syringe, or lines marking the syringe for dosing J Clin Oncol 2009. 27:891-96

  24. Overall, lack of data on errors for OC use at home • Few studies have evaluated the problem • Area of concern while more chemotherapy is being used at home • Highlights importance of education for patients, families, pharmacists, and oncology team • Literature generally indicates an error rate of 3-10% for chemotherapy related errors Pharmacotherapy 2008; 28:1-13, Oncol Nurs forum 1999; 26:1033-42, Am J Health Syst Pharm 1996;53:737-46

  25. What skills does the pharmacist need? • Proficient pharmacists should • Have appropriate knowledge of indications • Understand dosing and administration of oral chemotherapy • Aware of drug-drug interactions • Counsel patients on potential adverse events • Aware of special handling precautions

  26. Survey of community pharmacists about oral chemotherapy • 28 question survey to assess pharmacists knowledge of and attitudes toward OC • Survey population Colorado, Kansas, and Southeastern United States • 243 surveys returned (response rate 22.5%) • Knowledge of OC: 49.7% correct • General dosing principles: 69% correct • Special handling: 25% correct • Attitudes toward OC • Few indicated comfortable dispensing these agents • Most felt knowledge of OC is very important • Majority were “very interested” in attending a program about OC J Am Pharm Assoc 2008:48; 632-9

  27. Of interest… • Most pharmacists did not dispense more than 5 prescriptions for oral chemotherapy weekly • Pharmacy average volume was determined to be between 350 – 1750 prescriptions per week • < 1% of all prescriptions for OC • 5.3% of respondents did have a counting tray dedicated to Oral chemotherapy J Am Pharm Assoc 2008:48;632-9

  28. How has dispensing changed in the clinic – hospital setting • Chemotherapy preparation undergone a revolution • Specialized hoods • Specialized equipment • More protective personal equipment (PPE) recommended • Monitoring of staff and hoods for contamination • More data regarding safety available • Continued improvements

  29. Reasons for these changes • USP 797 requirements • Improved technology • Documented increased risk of cancer in nurses (and pharmacists?) who prepared chemotherapy • Documented blood levels of chemotherapy in health care workers • With new technology, those who unpacked the drug orders from wholesaler were only staff with levels measured

  30. Lets examine the newer dispensing methods in institutions • Special Thanks to Robin Ferra for letting us film her during the process!

  31. How does this differ from community pharmacy?

  32. Options for obtaining oral chemotherapy • Mail order pharmacy • Concern over quantities dispensed (90 days) • Costs • Errors: dose adjustments • Disposal of unused medications • Patient education-no interaction with the RPh • Specialty pharmacies • Drug interactions can be missed • Lack of access • Hospital pharmacies • Clinic-based pharmacies • Community pharmacy

  33. Are there any published recommendations to guide practice? • American Society of Health Systems Pharmacists • National Comprehensive Cancer Network • American Pharmacists Association? • ‘In the land down under’, of all places…

  34. ASHP • No specific guidelines for community pharmacy • Extrapolating their guidelines toward community practice would include: • DOES recommend counting of cytotoxic drugs on a tray dedicated that class of drugs • Recommends not putting cytotoxic drugs in automated dispensing devices • Use of personal protective equipment • Prepare agents in a designated area-do not crush, or split tablets • States “special handling procedures policies for hazardous drugs should be established in any pharmacy setting that dispenses hazardous drugs, and all employees of the pharmacy should be educated on the policies” Am J Health Syst Pharm 2006;63:1172-93

  35. NCCN – national comprehensive cancer network • Task force report published in 2008 regarding oral chemotherapy • Highlights increased interest, increasing use of and concerns with oral chemotherapy • Discusses dispensing issues • Patient and health care safety • Safe dispensing: double checking, protocol driven • Costs discussed • Provides no conclusions or guidelines to improve practice JNCCN 2008:6. Suppl 3. S1-16

  36. What is going on in Australia? • Developed Standards of Practice for the provision of oral chemotherapy for the treatment of cancer • They are not legally binding – noted in introduction to the guide • Society of Hospital Pharmacists of Australia (SHPA) developed these • “Oral chemotherapy must be subject to the same stringent prescribing and checking procedures as chemotherapy administered by other routes” J Pharm Pract Res 2007: 37(2) 149-52

  37. SHPA standards • Verification of prescription • Prescription should be screened by pharmacist with experience in cancer treatment-2nd check • Chemotherapy must be prescribed in context of a referenced protocol • Prescription must state, for each course of therapy • Drug • Dose • Route • Intended start date • Duration of therapy • If relevant-intended stop date

  38. Dispensing elements addressed in the standards • Ensure proper dose, treatment intervals • Verify disease, laboratory values, organ function • Specific labeling instructions also delineated • Dose • Tablet number • Start/stop dates • Labeling of each box • Quantity to dispense included in the standards • Cytotoxic warning stickers shpa guidelines

  39. Health and safety addressed • Avoid skin contact • Avoid “liberation of aerosol” of powdered medications into the air • Avoid cross-contamination of other medications • Therefore, if possible unit dose packaging is preferred • Use of gloves recommended • Hand wash after each dispensing • Separate specially designated counting tray and spatula labeled for that purpose • Washed with detergent and water after use shpa guidelines

  40. Health and safety • No crushing or tablet splitting in pharmacy • If dose is unusual, liquids should be obtained from manufacturer, or specialized facility where compounding is done in a non-sterilized cytotoxic hood (not easy to locate such facilities). • Do not compound oral agents within the cytotoxic drug safety cabinet because of contamination—Differs from some US recommendations found shpa guidelines

  41. Counseling • Required for each oral chemotherapy prescription • Can be achieved at the clinic • Written material must also be supplied • Supportive care included • 24 hour access to health care team must also be included • Storage of medications – AWAY from Children • Safe handling of medications by family shpa guidelines

  42. Example of counseling for Xeloda • Take with water within 30 minutes of a meal • If a dose is missed, do not take when you remember, and do not double-up dose next time • Stop taking and contact your oncology team if experiencing 4 or more bowel movements per day, diarrhea at night, loss of appetite, large reduction in fluid intake, if you vomit more than 1 time in a day, mouth sores, temperature greater than 100.4, or pain, redness or swelling in the hands and feet that prevents normal activity • Avoid exposure to sunlight. Wear sunscreen, lip protection, hat.

  43. General dispensing information Review of principles Counseling points in general Handout for specific agent counseling Handling Disposal

  44. Information on prescription to properly verify • Patient name, date of birth, height, weight and body surface area (verified by the pharmacist) • Patient’s diagnosis • Protocol used, including other medications • Dose per m2 and dose for the patient • Duration of therapy – specific information regarding days of therapy • Signed by oncologist (not the Fellow, the Resident the primary care physician, nor the secretary) • Days supply should be no more than 4 – 6 weeks in general (most often less)

  45. Obtain the protocol • In general, ask the oncology clinic to provide protocol with references, Lexicomp, chemoregimen.commay contain some standard protocols • These references should be verified • Package insert will have minimum and maximum dosing information • Must have diagnosis to correctly verify the protocol • Diagnosis should contain treatment and stage information. • For example: Adjuvant breast cancer or advanced lung cancer, second line therapy

  46. Dispensing details • Obtain and use separate counting tray and spatula • Have a separate area to dispense for these agents • Clean with detergent and water-not alcohol • Use gloves • Consider having cytotoxic agents separate from general inventory • Consider wearing a separate laboratory coat for this activity • Consider wearing a mask

  47. Special handling • Recommended to wear gloves with cytotoxic agents • Also recommended with hormonal agents • Targeted therapies??

  48. Cytotoxic agents vs hormonal agents cytotoxic hormonal Tamoxifen Toremefine Exemestane Letrozole Anastrozole (Arimodex) Bicalutamide Flutamide Nilutamide • Temozolomide • Capecitabine • Thalidomide • Cyclophosphamide • Methotrexate • Procarbazine • Hydroxyurea • Mercaptopurine • Chlorambucil • Lomustine

  49. Targeted therapies Drugs Recommendations At this time, no special handling procedures are required. • Imatinib (Gleevec®) • Dasatinib (Sprycel®) • Nilotinib (Tasigna®) • Lapatinib (Tykerb®) • Erlotinib (Tarceva®) • Gefitinib (Iressa®) • Sunitinib (Sutent®)

  50. To use the BSA to calculate a dose: • Pt height: 65”, weight: 75 kg • BSA = 1.25 m2 using Mosteller • Dose of temozolomide is 75 mg/m2 daily • Calculate the dose: 75 mg/m2 x 1.25 = 93.75 mg • Most likely, based on available strengths, this dose would be rounded up to 100 mg daily

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