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Maggie Charpentier, PharmD, BCPS Clinical Associate Professor University of Rhode Island Per-diem pharmacist: Roger Williams Medical Center.

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Presentation on theme: "Maggie Charpentier, PharmD, BCPS Clinical Associate Professor University of Rhode Island Per-diem pharmacist: Roger Williams Medical Center."— Presentation transcript:

1 Maggie Charpentier, PharmD, BCPS Clinical Associate Professor University of Rhode Island Per-diem pharmacist: Roger Williams Medical Center

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

4 1. In RI or within 20 miles of RI 2. Outside RI and 20 miles surrounding area :10

5 1. Not confident 2. Somewhat confident 3. Neutral 4. Confident 5. Strongly Confident :15

6 1. Yes 2. No :10

7 1. Yes 2. No :10

8 1. Yes 2. No :10

9 1. Yes 2. No :10

10 1. Yes 2. No :10

11 :15 1. Sunitinib 2. Exemastane 3. temazolamide 4. I don’t know

12 1. Tell the wife to place in a ziplock bag and hit with a mallot, then rinse into a cup of water to drink 2. Prepare a liquid formulation in pharmacy by crushing tablets and mixing with simple sugar syrup, giving a 30 day expiration 3. Call the doctor 4. I don’t know :30

13 1. Call your doctor for any temperature 2 degrees above your normal temperature 2. If you have symptoms of sore throat, or cough, call the doctor only if accompanied by a fever 3. Avoid contact with anyone who is ill. 4. All of the above 5. I don’t know :20

14 1. Edema is common 2. Take within 30 minutes of a meal 3. Skin rash indicates higher efficacy 4. All of the above 5. I don’t know

15 1. Erlotinib (Tarceva®) 2. Sunitinib (Sutent®) 3. Lapatinib (Tykerb®) 4. All of the above 5. I don’t know :15

16 1. Temodar® 2. Tarceva® 3. Sutent® 4. All of the above 5. I don’t know :10

17  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  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  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  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  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 :

22  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 :891-96

23  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 :891-96

24  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: , Am J Health Syst Pharm 1996;53:737-46

25  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  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  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  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  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  Special Thanks to Robin Ferra for letting us film her during the process!

31

32  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  American Society of Health Systems Pharmacists  National Comprehensive Cancer Network  American Pharmacists Association?  ‘In the land down under’, of all places…

34  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:

35  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  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)

37  Verification of prescription  Prescription should be screened by pharmacist with experience in cancer treatment-2 nd 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  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  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  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  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  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 Review of principles Counseling points in general Handout for specific agent counseling Handling Disposal

44  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 m 2 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  In general, ask the oncology clinic to provide protocol with references, Lexicomp, chemoregimen.com may 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  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  Recommended to wear gloves with cytotoxic agents  Also recommended with hormonal agents  Targeted therapies??

48 CYTOTOXIC  Temozolomide  Capecitabine  Thalidomide  Cyclophosphamide  Methotrexate  Procarbazine  Hydroxyurea  Mercaptopurine  Chlorambucil  Lomustine HORMONAL  Tamoxifen  Toremefine  Exemestane  Letrozole  Anastrozole (Arimodex)  Bicalutamide  Flutamide  Nilutamide

49 DRUGS  Imatinib (Gleevec®)  Dasatinib (Sprycel®)  Nilotinib (Tasigna®)  Lapatinib (Tykerb®)  Erlotinib (Tarceva®)  Gefitinib (Iressa®)  Sunitinib (Sutent®) RECOMMENDATIONS  At this time, no special handling procedures are required.

50  Pt height: 65”, weight: 75 kg  BSA = 1.25 m 2 using Mosteller  Dose of temozolomide is 75 mg/m 2 daily  Calculate the dose: 75 mg/m 2 x 1.25 = mg  Most likely, based on available strengths, this dose would be rounded up to 100 mg daily

51  How/when to take medication  Address “gaps” in therapy i.e. take days 1-21 of 28 days.  Duration of treatment  What to do if miss a dose?  Swallow tablets whole, do not chew, crush  Review risks of crushing and mixing capsules with food  Review important drug-drug, drug-food, drug- herb interactions  Expected adverse effects  When to take supportive care medications  Principles of safe handling, disposing  Storage

52  Clinic should have provided a calendar for the patient. If not, consider developing one

53 SundayMondayTuesdayWednesdayThursdayFridaySaturday 1 Start capecitabine 2 Capecitabine 3 capecitabine 4 capecitabine 5 capecitabine 6 capecitabine 7 capecitabine 8 capecitabine 9 capecitabine 10 capecitabine 11 capecitabine 12 Capecitabine 13 capecitabine 14 LAST DAY OF capecitabine 15 Clinic Visit Start capecitabine 23 capecitabine 24 capecitabine 25 capecitabine 26 capecitabine 27 capecitabine 28 Capecitabine 29 Capecitabine 30 Capecitabine 31 Capecitabine 1 Capecitabine 2 Capecitabine 3 Capecitabine 4 LAST DAY OF Capecitabine

54  Nausea and vomiting  Myelosuppression  Diarrhea  Mucositis  Hand – foot syndrome  Rash  Hypertension  Serious reactions – when to contact the oncology clinic, or go to the emergency room

55  Instruct patient not to take whenever they “remember,” nor double-up on medication  Contact oncology clinic if missed dosing occurs greater than half the dosing interval  For weekly dosing (methotrexate) there is a bit of leeway here.

56  Best managed by preventing nausea and vomiting  Nausea-hard candy, small frequent meals, chewing gum  If patient vomits more than once per 24 hours, call MD  If vomiting each day, call oncology team: reconsider oral chemotherapy  PRN scripts should be written for patients  PRN scripts:  Prochlorperazine  Metoclopramide

57  Cyclophosphamide > 100 mg/m 2  EtoposideTemozolomide > 75 mg/m 2  EstramustineLomustine (single dose)  Procarbazine  Less common (< 10%):  Busulfan  CapecitabineChlorambucil  Cyclophosphamide < 100Hydroxyurea  ImatinibLapatinib  MercaptopurineMethotrexate  SorafinibSunitinib  Thalidomide NCCN.org antiemetic guidelines 2010

58  Common dose limiting side effect:  Especially with temozolomide, lomustine, hydroxyurea, targeted therapies  Can occur with capecitabine  At risk for infection – when Absolute Neutrophil count is below 500, especially when lower than 100

59  Check for temperature – any temp > call the oncology team/go to ED  Any signs of infection such as: chills, cough, sore throat, shortness of breath, pain or burning on urination, pain or swelling, redness at a port site – contact the oncology team/go to ED  Avoid contact with anyone who is ill.

60  Some drugs can cause anemia. Symptoms include fatigue, shortness of breath, and if history of arrhythmias, may lead to arrhythmia, chest pain. If these symptoms develop, recommend patient go to ED.

61  Symptoms would be increased bruising, and bleeding. Bloody nose, gums, urine, or stool (can also be black stools).  Any bleeding should be evaluated. If patient has bleeding, should go to ED.  Use soft toothbrush, electric razor.

62  Commonly occurs with capecitabine  Counseling tips  Avoid dairy, prune juice or caffeine  Replace fluids and electrolytes  If fever, go to ED  Loperamide 2 tablets at start of diarrhea  Continue with one tablet every 2 hours until diarrhea resolved for 12 hours  If uncontrollable, go to ED

63  Occurs with higher doses of methotrexate, cyclophosphamide, also capecitabine  Prevention: avoid hot, spicy, foods, “sharp foods” like potato chips  Brush with soft toothbrush  Treatment: avoid alcohol containing products, mouth rinses  Rinse mouth out with Biotene, or sodium bicarbonate and salt rinse  Magic mouthwash, Carafate suspension

64  Capecitabine – most common  Also mercaptopurine, sorafinib, hydroxyurea  Skin reaction appears most commonly on the palms of the hands and soles of the feet  May appear on other areas body that experiences increased pressure or warmth

65  Some chemotherapy (capecitabine) risk 32 – 74%  Severe PPE 0 – 63%  Theory:  Accumulation of drug metabolites in skin, elimination of chemotherapy and metabolites through sweat glands. Vascular degeneration results in skin death in areas of high blood flow, especially with local pressure, and abrasion.

66  Starts with several days of dysesthesias of the palms or soles  A painful symmetrical erythema appears  Often with edema  Less frequent areas involved  Groin  Buttocks  Under pendulous breasts  axillae

67  Time to occurrence 2 – 12 days of starting therapy  With proper management, PPE can be mild and resolve in 1 – 2 weeks  If not attended to, PPE can evolve into blistering desquamation, crusting, ulceration, and epidermal necrosis  Even mild, PPE can interfere with daily activities and be uncomfortable

68  Reduce pressure or abrasion to the skin  Avoid blood vessel dilatation  Wear loose clothing and footwear  Keep skin moist with emollients  Avoid hot climatic conditions (warm vs hot showers), harsh soaps, or detergents  Pat skin dry rather than rubbing  Effects of prevention are modest

69  Chemotherapy dose reduction  Less frequent dosing  Withdrawal from the drug  Early detection is key to preventing severe reactions  Therefore, important to counsel patient to call oncology team with any symptoms

70  Emollients  Bag balm, aloe vera lotion, urea based creams  Apply three times daily  Has demonstrated improvements  Cooling measures – ice packs  Recommend close surveillance during therapy – notify health care provider

71  Specifically due to tyrosine kinase inhibitors  Usually due to agents that target EGFR  Skin, hair follicles, and nails  Within the epidermis, EGFR stimulates epidermal growth, inhibits cell differentiation, protects against sun damage, inhibits inflammation and accelerates wound healing  Resultant breaks in skin integrity and accumulation of nonviable cells favors bacterial overgrowth, and increased risk of infections

72  Data suggests rash indicates better response to treatment  In some protocols, attempts made to increase dose to elicit significant skin rash.

73  In one trial in pancreatic cancer, overall 81% of patients developed a grade 2 rash to erlotinib  In patients who experienced a rash, median survival was 7.1 months (grade 1), 11.1 months (grade 2), versus a median survival of 3.3 months in patients with no rash j Clin Oncol 2007; 25:

74  Use a thick emollient cream  Protection from sunlight; use sunscreen with a minimum of SPF 15  Wear hat, coverage outside preferable  Remember the lips!

75  Mild: no treatment of rash, or can consider using low potency topical steroids and/or topical antibiotics such as clindamycin  Moderate: topical hydrocortisone or pimecrolimus or clindamycin gel plus systemic antibiotics (doxycycline or minocycline)

76  Severe: systemic corticosteroid pulse and taper plus therapies for moderate rash  Mild to moderate rashes-continue cancer therapy  Severe: dose held or lowered until rash improves  Counsel patients with rash to contact oncology team

77  HTN Common with sunitinib (about 30% of patients)  Also associated with heart failure  Monitor blood pressure for first 6 weeks  Usually treated with medications  Monitor for symptoms of heart failure: increased fluid, shortness of breath, fatigue (which is a common side effect)- clinic should be monitoring ejection fraction as well

78  If miss a dose, can take within dosing interval- half of the dosing interval- but if more than that, call oncology team  For example, daily dose, take within 12 hours, for q12 hour dose take within 6 hours  Never double up on doses!  Take at same time each day if possible  If vomit within hour of dose, call oncology team  If vomiting – contact oncology team

79  Refer to handout for tips on specific agents  In general, look over labeling information for changes  Important to remain updated  Remember, most of these patients are also using other agents administered at the clinic in conjunction, which will make toxicities more pronounced

80  Wear gloves  Do not crush  Wash hands immediately following  If touching body fluids, wear gloves

81  Not down the toilet!  Kitty litter or coffee grounds  Sealed in regular trash-animals nor children should be able to easily open  If possible, clinic should accept back for proper storing-very few do this  Drug take-back programs  d/Reducing%20Pharm%20Waste%20White% 20Paper.pdf d/Reducing%20Pharm%20Waste%20White% 20Paper.pdf

82  Oral chemotherapy will not replace office-based infusions of chemotherapy  Will become more prevalent  Will require more vigilance on part of the patient, the oncologist, oncology nurse, and the pharmacist  Pharmacists must become knowledgeable in safe dispensing, and proper counseling  Next step: preparing pharmacists to assist with adherence!

83

84 1. Not confident 2. Somewhat confident 3. Neutral 4. Confident 5. Strongly Confident :15

85 1. Yes 2. No :10

86 1. Yes 2. No :10

87 1. Yes 2. No :10

88 1. Yes 2. No :10

89 1. Yes 2. No :10

90 :15 1. Sunitinib 2. Exemastane 3. Temazolamide 4. I don’t know

91 1. Tell the wife to place in a ziplock bag and hit with a mallot, then rinse into a cup of water to drink 2. Prepare a liquid formulation in pharmacy by crushing tablets and mixing with simple sugar syrup, giving a 30 day expiration 3. Call the doctor 4. I don’t know :30

92 1. Call your doctor for any temperature 2 degrees above your normal temperature 2. If you have symptoms of sore throat, or cough, call the doctor only if accompanied by a fever 3. Avoid contact with anyone who is ill. 4. All of the above 5. I don’t know :30

93 1. Edema is common 2. Take within 30 minutes of a meal 3. Skin rash indicates higher efficacy 4. All of the above 5. I don’t know :20

94 1. Erlotinib (Tarceva®) 2. Sunitinib (Sutent®) 3. Lapatinib (Tykerb®) 4. All of the above 5. I don’t know :15

95 1. Temodar® 2. Tarceva® 3. Sutent® 4. All of the above 5. I don’t know :10


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