Transcript oral Chemotherapy - Maine Pharmacy Association

Maggie Charpentier, PharmD, BCPS
Clinical Associate Professor University of Rhode Island
Per-diem pharmacist: Roger Williams Medical Center
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Goal:
Educate pharmacists regarding counseling and safe
dispensing of oral chemotherapy in community pharmacy
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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
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1.Community
pharmacy
2.Outpatient clinic
3.Hospital setting
4.Non – dispensing
practice site
5.Other
di
sp
en
4.
No
n
–
ta
l
5.
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r
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3.
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sp
i
nt
at
ie
2.
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tp
1.
Co
m
m
un
it y
ph
.. .
20% 20% 20% 20% 20%
:10
1.
2.
In RI or within 20
miles of RI
Outside RI and 20
miles surrounding
area
:10
0%
ng
ly
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nf
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.
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en
t
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St
ro
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5.
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co
nf
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en
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m
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2.
Not confident
Somewhat
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Neutral
Confident
Strongly Confident
No
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2.
Yes
No
Ye
s
1.
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0%
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s
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1.
2.
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m
id
e
ol
a
az
te
m
25%
Id
on
’t
kn
ow
25%
ne
25%
m
as
ta
4.
Ex
e
3.
25%
ni
b
2.
Sunitinib
Exemastane
temazolamide
I don’t know
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ife
w
4.
0%
he
3.
ll t
2.
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
Te
1.
:30
4.
5.
0%
0%
0%
0%
0%
ou
rd
oc
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.
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...
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..
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on
’t
kn
ow
3.
ly
2.
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
Ca
l
1.
:20
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ke
5.
0%
co
m
4.
is
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m
a
2.
Edema is common
Take within 30
minutes of a meal
Skin rash indicates
higher efficacy
All of the above
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Ed
e
1.
0%
of
t
Id
on
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0%
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ni
ti
5.
(T
4.
ib
3.
tin
2.
Erlotinib (Tarceva®)
Sunitinib (Sutent®)
Lapatinib (Tykerb®)
All of the above
I don’t know
Er
lo
1.
:15
0%
0%
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l
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Temodar®
Tarceva®
Sutent®
All of the above
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1.
:10
Traditionally – chemotherapy was rarely dispensed in the
community pharmacy
 Little or no data on safe practice
 Some agents:
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Busulfan
Chlorambucil
Etoposide
Lomustine
Mercaptopurine
Procarbazine
Temozolomide
Capecitabine
Cyclophosphamide
Hydroxyurea
Melphalan
Methotrexate
Thalidomide
 targeted agents: imatinib, erlotinib, etc
 Hormonal agents: tamoxifen, anastrozole
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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
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Medication errors
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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.
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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.
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
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J Clin Oncol 2009. 27: 891-96.
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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
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Improved communication
Improved technology
 Computer order entry
 EMAR
 EMR
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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
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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
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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
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
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 General dosing principles:
 Special handling:
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Attitudes toward OC
69% correct
25% correct
 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
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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
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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
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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
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Special Thanks to Robin Ferra for letting us
film her during the process!
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Mail order pharmacy
 Concern over quantities dispensed (90 days)
▪ Costs
▪ Errors: dose adjustments
▪ Disposal of unused medications
 Patient education-no interaction with the RPh
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Specialty pharmacies
 Drug interactions can be missed
 Lack of access
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Hospital pharmacies
Clinic-based pharmacies
Community pharmacy
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American Society of Health Systems
Pharmacists
National Comprehensive Cancer Network
American Pharmacists Association?
‘In the land down under’, of all places…
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No specific guidelines for community pharmacy
Extrapolating their guidelines toward
community practice would include:
 DOES recommend counting of cytotoxic drugs on a
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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
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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
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Provides no conclusions or guidelines to improve
practice
JNCCN 2008:6. Suppl 3. S1-16
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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
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
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Drug
Dose
Route
Intended start date
Duration of therapy
If relevant-intended stop date
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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
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Quantity to dispense included in the standards
Cytotoxic warning stickers
shpa guidelines
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
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 Washed with detergent and water after use
shpa guidelines
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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
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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
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.
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Review of principles
Counseling points in general
Handout for specific agent counseling
Handling
Disposal
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)
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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
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 Diagnosis should contain treatment and stage
information.
 For example: Adjuvant breast cancer or advanced lung
cancer, second line therapy
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
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Recommended to wear gloves with cytotoxic
agents
Also recommended with hormonal agents
Targeted therapies??
CYTOTOXIC
HORMONAL
Temozolomide
 Capecitabine
 Thalidomide
 Cyclophosphamide
 Methotrexate
 Procarbazine
 Hydroxyurea
 Mercaptopurine
 Chlorambucil
 Lomustine
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Tamoxifen
 Toremefine
 Exemestane
 Letrozole
 Anastrozole (Arimodex)
 Bicalutamide
 Flutamide
 Nilutamide
DRUGS
RECOMMENDATIONS
Imatinib (Gleevec®)
 Dasatinib (Sprycel®)
 Nilotinib (Tasigna®)
 Lapatinib (Tykerb®)
 Erlotinib (Tarceva®)
 Gefitinib (Iressa®)
 Sunitinib (Sutent®)
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At this time, no special
handling procedures are
required.
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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
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, drugherb interactions
 Expected adverse effects
 When to take supportive care medications
 Principles of safe handling, disposing
 Storage
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Clinic should have provided a calendar for the
patient. If not, consider developing one
Sunday
Monday
Tuesday Wednesday Thursday
1
Start
capecitabine
Friday
Saturday
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
16
17
18
19
20
21
22
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
5
6
7
8
9
10
11
12
13
14
15
16
17
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Nausea and vomiting
Myelosuppression
Diarrhea
Mucositis
Hand – foot syndrome
Rash
Hypertension
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Serious reactions – when to contact the
oncology clinic, or go to the emergency room
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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.
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:
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 Prochlorperazine
 Metoclopramide
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Cyclophosphamide > 100 mg/m2
Etoposide
Temozolomide > 75 mg/m2
Estramustine
Lomustine (single dose)
Procarbazine
Less common (< 10%):
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Busulfan
Capecitabine
Cyclophosphamide < 100
Imatinib
Mercaptopurine
Sorafinib
Thalidomide
NCCN.org antiemetic guidelines 2010
Chlorambucil
Hydroxyurea
Lapatinib
Methotrexate
Sunitinib
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Common dose limiting side effect:
 Especially with temozolomide, lomustine,
hydroxyurea, targeted therapies
 Can occur with capecitabine
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At risk for infection – when Absolute
Neutrophil count is below 500, especially
when lower than 100
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Check for temperature – any temp > 100.4
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.
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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.
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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.
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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
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
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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
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Some chemotherapy (capecitabine) risk 32 –
74%
 Severe PPE 0 – 63%
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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.
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Starts with several days of dysesthesias of
the palms or soles
A painful symmetrical erythema appears
Often with edema
Less frequent areas involved
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Groin
Buttocks
Under pendulous breasts
axillae
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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
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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
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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
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Emollients
 Bag balm, aloe vera lotion, urea based creams
 Apply three times daily
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Has demonstrated improvements
Cooling measures – ice packs
Recommend close surveillance during
therapy – notify health care provider
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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
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Data suggests rash indicates better response
to treatment
In some protocols, attempts made to
increase dose to elicit significant skin rash.
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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; 25:1960-6.


Use a thick emollient cream
Protection from sunlight; use sunscreen with
a minimum of SPF 15
 Wear hat, coverage outside preferable
 Remember the lips!


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)




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



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

If miss a dose, can take within dosing intervalhalf 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




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




Wear gloves
Do not crush
Wash hands immediately following
If touching body fluids, wear gloves






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
http://web.ascp.com/advocacy/briefing/uploa
d/Reducing%20Pharm%20Waste%20White%
20Paper.pdf
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!

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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
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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
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Take within 30
minutes of a meal
Skin rash indicates
higher efficacy
All of the above
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Erlotinib (Tarceva®)
Sunitinib (Sutent®)
Lapatinib (Tykerb®)
All of the above
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Tarceva®
Sutent®
All of the above
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