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Washington Metropolitan Society of Health-System Pharmacists OPPharmactsNewsletter
July Issue 2012
Wmshp Newsletter
How strong are we?
When counseling breastfeeding mothers who intend to take or are taking medications (prescription, over-the-counter, and/o herbal), the questions below should be considered and asked. The provided a answers are necessary to properly counsel mothers on the safe and effective use of medications while breastfeeding.
What is the name, strength, and dosage form of the drug?
This is the basic information needed to evaluate any situation involving drug use.
Useful Tools and Techniques for Counseling Breastfeeding Women By Frank J. Nice, RPh, DPA, CPHP
July 2012
Contents
1, 5-8
Cefepime poses risk for Nonconvulsive Status Epiliepticus in Patients with Renal Failure 4
Useful Tools and Techniques for Counseling Breastfeeding Women
President’s message 2
Some Patients on Warfarin Who Have a Stroke Might Safely Receive tPA 4
Newsletter Editor Monique Bonhomme, MS, PharmD
Continued on pages 6-8
Meetings 3
Save the Date 7 Members Section 10
Have you ever wondered how many members we have?
144 – Active Paid members
Have you wondered where our members practice?
- Government, hospital, retail, pharmaceutical
companies, consultants, and independent practice
- We also consist of pharmacy residents, pharmacy
students, technicians, and retired pharmacists.
Walgreens, Other Pharmacies to Offer Free HIV Testing 4 Practical Issues Involved with Oral Cancer 9-11Pharmacogenetic Testing: Focus on Clopidogrel 9, 11-13
Washington Metropolitan Society of Health-System Pharmacists July 2012
2
President’s message
We just completed a successful Residency Showcase. I would like to see this continue over the years as the
ASHP residency program is becoming more important to the new graduates each year. I want to thank the
board for their efforts in making the Showcase successful. I want to especially thank Evelyn Edwards for
the work she did in setting up the food along with the meeting rooms and Monique Bonhomme for
organizing the registration and C.E. Everything ran like clockwork. I need to not forget the volunteer
students from University of Maryland Shady Grove who gave up a Saturday to help us. It is great to see
the interest they have in our organization and the willingness to help.
By July we should have the Annual Meeting finalized and information sent to everyone soon after. I am
excited about the speakers we have secured from various health systems with talks on personalizing your
medication, to infusion service, to psychiatric care.
On other fronts, our treasurer is working on putting together a budget, which we should have available for
the members in the near future. I once again am asking for volunteers for committees as we have much
work to be done. Our treasurer, John Pelosi, is asking for volunteers for an audit committee. I would like
to see volunteers for program committee in arranging speakers and helping Evelyn and Monique in the
work they do in setting up meetings. We would like to know what you are doing professionally as well as
personally for articles in the newsletter as we want our newsletter to be informative and even socially
interesting to our members. Birth announcements or special birthdays anyone? New positions? Let us
know. Finally, I want everyone to start thinking. Our elections are around the corner. Who among you
would like to find out what it is like to work with the board of a great organization? If not who among you
would like to get your feet wet by volunteering for a committee? We need an election committee!
Finally, we are working on having credit card billing available on our website for meetings and
membership. I will keep you posted on the progress.
HAVE A GREAT SUMMER!
Leon Vandenberg, WMSHP President
Editor’s note:
I present to you the July 2012 WMSHP Newsletter. My goal is to make this a forum for the members of WMSHP to contribute, showcase their many talents, and express their opinions. I would like our members to actively participate in reviving WMSHP as an organization that they are proud to be a part of. I would also like to thank those members who have submitted their great work in this issue.
Monique, WMSHP Secretary
Washington Metropolitan Society of Health-System Pharmacists July 2012
3
WMSHP Spring Meeting
BOARD MEETING MINUTES – JUNE 28, 2012 Members Present: Monique Bonhomme, Evelyne Edwards, Michael Edwards, Beatrix Lam, Olumbumimi
Momoh, John Pelosi, Leon Vandenberg
2012 WMSHP Spring Meeting – Scheduled September 22, 2012 – 6 CEUs - Speakers are lined up and brochure will be emailed out to members once finalized - Exhibitors will have 1 longer session as opposed to 2 sessions in the past - Exhibitors who support us continuously will be offered a discount to exhibit at WMSHP meetings
Budget: - Treasurer noted: Working balance as of July: $12,871.71 – Budget to be sent out to members - September meeting: Committed $3,249.79 to 4-H – (1/2 of the deposit paid) - April balance: $15,199.31; May balance: $18,064.11; June balance: $17,479.13 (+$2,600 +$5,988.38)
Finance: - Voted to approve President and Treasurer to file for Certification and Corporate Resolution for
Investment/Growth stock under WMSHP in order to transact business on the account Membership:
- Dues: Discussion to raise dues starting next year in order to continue offering increased membership services, such as free CE to members; researching area organizations membership fees – final decision on increase will be deferred to August board meeting
- Need to cut back on offering 20 hours of free CE to 15 hours – costs too much Website:
- Problems with communication and getting credit card billing set-up with website managers - Decided to start looking at other options for management of website
Elections/Delegate report: - 2013: Need nominations for President-Elect and 2 Delegates - Current delegates will write up an ASHP Delegate Report to be sent out to members
Annual WMSHP Fall Meeting – 6 CEs “NOW AND THE FUTURE”
WHEN: Saturday, September 22, 2012 TIME: 0745 (Registration and Continental Breakfast)
1645 – Program concludes
LOCATION: National 4-H Youth Conference Center 7100 Connecticut Avenue Chevy Chase, MD 20815
AGENDA: TBA
RSVP to [email protected]
Prior to September 19th: Members: Free Non-member fee: $85
After September 19th: Members: $25 Non-member fee: $110
Washington Metropolitan Society of Health-System Pharmacists July 2012
4
Some Patients on Warfarin Who Have a Stroke
Might Safely Receive tPA
Some patients on warfarin (with an international
normalized ratio of 1.7 or lower) may safely receive
tissue plasminogen activator (tPA) therapy following
an ischemic stroke, according to an observational
study in JAMA.
Researchers used data from a U.S. stroke registry to
examine outcomes in some 23,000 patients treated
with tPA in 1200 hospitals. All presented with an INR
of 1.7 or lower. Among those on warfarin before
admission (about 8% of the cohort), the adjusted risk
for symptomatic intracranial hemorrhage was the
same as the risk among those not on warfarin.
An editorialist praises the study, but also points out
that the most patients had INRs lower than 1.5: "Thus,
it is not surprising that intravenous tPA was
relatively safe in the overall cohort." He also warns
against extrapolating the results with warfarin to
patients on the newer anticoagulants dabigatran and
rivaroxaban.
JAMA article (Free)
Cefepime Poses Risk for Nonconvulsive Status
Epilepticus in Patients with Renal Impairment
Patients with renal impairment who are taking the
antibacterial drug cefepime need to have their
dosage adjusted, the FDA reminded clinicians on
Tuesday, citing new information on the risk for
nonconvulsive status epilepticus in such patients.
The agency has received 59 reports of
nonconvulsive status epilepticus in cefepime users
with renal impairment, most of whom did not
have their dosage adjusted. In most cases, the
seizures were reversible and stopped once
cefepime was discontinued or after hemodialysis.
To reduce the risk for seizures, the FDA says,
clinicians should adjust the dose of cefepime in
patients with creatinine clearance at or below 60
mL/minute. If seizures occur, clinicians should
consider discontinuing the drug or further
adjusting the dose.
The risk for nonconvulsive status epilepticus will
be added to the drug's label.
FDA MedWatch safety alert (Free)
FDA drug safety communication (Free)
Walgreens, Other Pharmacies to Offer Free HIV Testing Walgreens pharmacy will begin offering free, rapid HIV testing in one of its locations in Chicago, Washington, D.C.,
and Lithonia, Georgia, Reuters reports.
The initiative is part of a 2-year pilot program with the CDC. Ultimately, a total of 24 community pharmacies and retail
clinics — 12 in cities and 12 in underserved rural communities — will offer testing.
People who test positive will be referred to local healthcare providers for confirmation and care.
Reuters story (Free)
CDC news release (Free)
Washington Metropolitan Society of Health-System Pharmacists July 2012
5
Do you still have the prescription? Or, have you already filled it and are taking the drug?
Asking this question helps get the proper perspective as to the stage of the drug / breastfeeding situation that is being evaluated. The mother may be seeking advice on whether to continue breastfeeding, if and when she takes the drug. She may be questioning whether she is acting correctly by taking the drug and continuing to breastfeed. And she may have concerns about possible adverse effects on her infant.
Why is the drug being prescribed?
Knowing the answer to this question can help the mother determine if, in fact, the drug is really necessary in a particular situation. This is best decided with the prescribing physician.
Do you feel you need to take the drug?
If the drug is being prescribed for a relatively benign condition, the mother may be willing to endure some personal inconvenience to spare the infant from potential effects of the drug. This is also best decided in conjunction with the prescribing physician.
What does your doctor say regarding breastfeeding outcome and taking the drug?
A doctor’s philosophy about breastfeeding and knowledge of drug effects on breast-feeding can play a large role in the doctor’s opinion as to whether the mother should continue to breastfeed. With knowledge of the doctor’s philosophy in relation to her own views on breastfeeding, the mother can decide if she wants to further pursue the physician’s decision. If a physician’s philosophy and a mother’s are in conflict, the mother should seek a second opinion.
What is the drug dosage schedule and how often do you nurse?
If a drug must be taken by a mother, and she wishes to continue to breastfeed, it may be possible to schedule the doses so that peak plasma and milk levels of the drug do not coincide with breastfeeding sessions. In most cases, it’s best for the mother to breastfeed just before taking a dose of a drug and / or at least two hours after taking a dose. Short-acting drugs taken on an every three to six hour schedule usually reach peak plasma and milk levels in approximately one hour.
How old is the baby?
Knowing this gives an indication of the infant’s ability to handle a particular drug. It also aids in determining the infant’s feeding schedule, which may influence dosage scheduling.
Was your baby full-term or premature?
The answer to this question supplies added information that helps determine the infant’s ability to detoxify drugs.
What is your baby’s weight?
This fact may be relevant to the quantity of the drug the baby may be able to tolerate without any adverse effects.
Washington Metropolitan Society of Health-System Pharmacists July 2012
6
Is your baby currently receiving any medication?
Any medication that the infant is receiving can interact with medication the infant receives through breast milk.
Do you know how to hand-express milk or do you have access to a breast pump?
In some cases, breastfeeding can be stopped temporarily while a drug is administered. In these situations, the mother must hand-express milk or pump her breast to prevent breast engorgement and to maintain her milk supply. The mother can learn to hand-express milk or to use a breast pump, if necessary, from lactation consultants or La Leche League consultants.
Is this your first breastfed baby?
Mothers who have breastfed in the past will be more knowledgeable about the whole breastfeeding process. A mother who is breastfeeding for the first time may find it more difficult to come to a decision regarding the use of a drug. Involving a breastfeeding consultant in the process, if this is acceptable to the mother, may be useful.
A stepwise approach based upon these answers can then be used to minimize infant drug exposure while breastfeeding. The steps evolve from not taking a medication to discontinuing breastfeeding. Steps can be skipped or combined as appropriate. Following this approach almost always allows the nursing infant to continue to breastfeed safely.
Withhold the Drug: Avoid the use of non-essential medications by enlisting the mother’s cooperation.
Try Non-Drug Therapies: Suggested therapies include: Analgesics: relaxation techniques, massage, warm baths. Cough, cold, allergy products: saline nose drops, cool mist, or steam. Anti-asthmatics: avoid known allergens, particularly animals. Antacids: eat small meals, sleep with head propped, avoid head-bending activities, and avoid gas-forming foods. Laxatives: eat high fiber cereal, prunes, or hot liquids with breakfast. Anti-diarrheals: discontinue solids 12-24 hours, increase fluids, and eat toast / saltine crackers.
Delay Therapy: Mothers who are ready to wean the infant might be able to delay elective drug therapy or elective surgery.
Choose Drugs That Pass Poorly Into Milk: Within some drug classes there are large differences among class members in drug distribution into milk.
Choose More Breastfeeding Compatible Dosage Forms: Take lowest recommended dose, avoid extra-strength and long acting preparations, avoid combination ingredient products.
Choose an Alternative Route of Administration: Local application of drugs to the affected maternal site may minimize drug concentrations in milk and subsequently the infant’s dose.
Washington Metropolitan Society of Health-System Pharmacists July 2012
7
Avoid Nursing at Times of Peak Drug Concentrations in Milk:
Nursing before a dose is given may avoid the peak drug concentrations in milk that occur about 1-3 hours after an oral dose. This works best for drugs with short half-lives.
Administer the Drug Before the Infant’s Longest Sleep Period: This will minimize the infant’s dose and is useful for long-acting drugs that can be given once daily.
Temporarily Withhold Breastfeeding: Depending on the estimated length of drug therapy, nursing can be temporarily withheld. Mothers may be able to pump a sufficient quantity of milk beforehand for use during therapy. The pharmacokinetics of the drug must be examined to determine when the resumption of breastfeeding is advisable.
Discontinue Nursing: A few drugs are too toxic to allow nursing and may be necessary for the mother’s health.
The following are useful breastfeeding websites that provide more breastfeeding and specific drug information:
Nice Breastfeeding
www.nicebreastfeeding.com
LactMed / TOXNET / NLM / NIH
http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Thomas Hale InfantRisk Center
http://www.infantrisk.com/category/breastfeeding
Breastfeeding Online
http://breastfeedingonline.com/
American Academy of Pediatrics Policy Statement
The Transfer of Drugs and Other Chemicals Into Human Milk
http://aappolicy.aappublications.org/cgi/content/full/pediatrics%3b108/3/776
Washington Metropolitan Society of Health-System Pharmacists July 2012
8
Benefits of Breastfeeding
• Bonding between mother and child • Better recovery with less blood loss at
birth • Delays return of a woman’s ovulation
and menstruation for a variable 20 to 30 weeks or more, providing a natural means of child spacing for many
• Enhance feelings of attachment between mother and baby
• Infant receives o Immunoglobulins o Enhanced immune response to
inoculations against: Polio Tetanus Diphtheria Influenza
o Nutrients o Growth factors o Lipoproteins/cholesterol needed
for brain and nerve development • In adolescent and adult life of the infant,
associated with: o Lower mean blood pressure o Lower total serum cholesterol o Lower prevalence of type 2
diabetes
Risks of Not Breastfeeding
• Post-partum hemorrhage by increasing level of oxytocin, which stimulates uterine contractions
• Pre-menopausal breast cancer • Ovarian cancer • Heart disease • Osteoporosis • Anemia • Obesity • Type 2 diabetes for women without a
history of gestational diabetes • Infants will have increased risks of:
o SIDS (Sudden Infant Death Syndrome)
o Infectious Diseases o Diarrhea
Ear Infections Upper Respiratory Tract
Infections • Bowel Diseases
o Crohn’s Disease o Ulcerative Colitis
• Cancer o Hodgkin’s Disease o Leukemia
• Diabetes • Obesity • Asthma • Eczema • Cavities • Decreased IQ (by 8-15 points) • Acute infections
o Diarrhea o Pneumonia o Ear Infection o Haemonphilus influenza o Meningitis o Urinary tract infection
• Chronic conditions in the future
Washington Metropolitan Society of Health-System Pharmacists July 2012
9
Practical Issues Involved with Oral Cancer Chemotherapy Ashley Chasick, PharmD Research and development of new oral chemotherapy
agents (OCAs) has grown exponentially in the last
decade. Eleven oral chemotherapy drugs have been
approved in the last ten years and an estimated 25% of
antineoplastics involved in ongoing research are oral
agents. OCAs can be utilized to treat a wide range of
malignancies including solid tumors (breast, brain,
renal, lung, ovarian, prostate, thyroid, and skin
cancers) as well as leukemias and lymphomas.
Although the majority of antineoplastic drugs are
administered intravenously, the number of OCAs
continues to grow. Oral chemotherapy agents are now
included as first line therapy for many cancers, such
as lenalidomide for the treatment of multiple
myeloma. Utilizing an oral route to deliver
chemotherapy certainly has advantages but these
advantages do not come without introducing a new
set of unique challenges. With the market for OCAs
expanding, pharmacists are tasked to consider issues
associated with the use of OCAs including patient
education, safe administration and handling,
monitoring for adverse effects, ensuring adherence.
Patient counseling is always important but it is critical
for patients receiving outpatient OCAs. Patients
should be counseled thoroughly about the adverse
effects of their medications. Pharmacists should
encourage patients to record any new symptoms and
share them with their oncology provider. The use of
oral chemotherapy may decrease oncology clinic
visits.
Pharmacogenomic testing: focus on clopidogrel. Elena Teger, PharmD, PGY1 Pharmacy Practice Resident, WRNMMC Bethesda – June 2012 Integration of genetics into clinical practice is a
fast growing field. The FDA encourages the
inclusion of genetic biomarkers in drug
development as well as their appropriate use in
therapeutics.1 The number of discovered genetic
biomarkers has been growing over the past
several years, with over 30 biomarkers that
currently appear in product labels 2. The use of
biomarkers enables pharmacists to identify
patients most likely to benefit from, or experience
adverse reactions to particular drugs.
Cytochrome P450 2C19 enzyme is implicated in
the metabolism of various drugs, including
antidepressants, benzodiazepines, oral
contraceptives, proton pump inhibitors, and
others. There are over 25 known variant alleles of
CYP2C19. The most common is a loss-of-function
of allele *2, which is seen in approximately ~15%
of Caucasians and African Americans, and ~29-
35% of Asians. Patients with heterozygous
phenotype (*1/*2, *1/*3) are classified as
intermediate metabolizers, whereas homozygous
patients (*2/*2, *3/*3) are poor metabolizers.
Approximately ~2-5% of Caucasians and African
Americans, and ~15% of Asian population are
poor metabolizers3. Clopidogrel is a P2Y12
inhibitor that reduces platelet aggregation. It is
indicated for treatment of patients with recent
myocardial infarction, stroke, or acute coronary
syndrome (ACS) with or without percutaneous
Washington Metropolitan Society of Health-System Pharmacists July 2012
10
Although this can be beneficial to patients it reduces the opportunities for clinicians to monitor for
adverse effects of therapy. Oncology providers should let patients know to call their physician’s
office or go to the emergency room if serious problems occur. Some centers have tried internet-
based programs to facilitate real-time reporting of chemotherapy toxicities, such as the STAR
program. The STAR program included patients with lung cancer and gynecologic malignancies.
Patients were given access to a web-based system to report symptoms at each clinic appointment
and from home. In one study examining the STAR program in 80 patients with gynecologic
malignancies, 42 severe toxicities were entered from patients’ homes, which resulted in 7 clinical
interventions. Web-based symptom logging system may be a useful tool for monitoring patients
while minimizing unnecessary clinic visits.
Oral chemotherapy regimens can be complicated with dosing schedules that vary throughout the
day and treatment cycle. Providing the patient and caregivers with a written schedule or calendar
can be helpful for those managing complicated oral regimens. Often patients are be overwhelmed
by the volume of information communicated to them during their oncology clinic visits. Providing
written materials allows the patient and their family to review drug information as questions arise.
Patients should be informed of any special instructions that apply to administration of the
medication such as taking it on an empty stomach or with a meal. A plan should be made for how
the patient should handle missed or late doses of OCAs.
Another issue unique to OCAs is the hazardous nature of the medications themselves. OCAs can
be teratogenic and mutogenic leading to birth defects, malignancies, or varying adverse effects.
OCAs can leave hazardous residue on the patient’s hands, prescription vials and pillboxes.
Patients should be advised to leave their OCA in its original container and wash their hands after
taking each dose. Any oral chemotherapy drug should be placed in childproof container, if
possible, and placed out of the reach of children, pets, and other family members. If the patient has
leftover medication due to missed doses or a change in treatment plan, the patient should be
advised to bring their unused medications back to their pharmacy or clinic for proper disposal.
Patient adherence is the Achilles heel of oral chemotherapy. Studies have shown non-adherence
rates ranging from 10-30% in patients taking OCAs. Non-adherence to chemotherapy medications
has been shown to negatively impact survival in studies of patients taking oral tamoxifen. Patients
may have many reasons for non-adherence including financial difficulties, fear of side effects,
disbelief in efficacy of treatment, confusion regarding medication scheduling, or forgetfulness.
Washington Metropolitan Society of Health-System Pharmacists July 2012
11
Pharmacists may assess the adherence of their
patients by asking them questions about their
medication schedule and how many doses of
medication they regularly miss. Any possible issues
with adherence should be reported to the patient’s
physician.
The advent of oral cancer chemotherapy is an
exciting time for oncology patients and providers.
Although freeing the patient from frequent
infusions seems ideal, there are real disadvantages
associated with orally administered chemotherapy.
Pharmacists can play a unique role in the
management of patients receiving OCAs. By
providing comprehensive patient education and
monitoring for adherence and adverse effects,
pharmacists can improve patient outcomes and
possibly increase survival rates.
References: Aisner J.Overview of the changing paradigm in cancer treatment: oral chemotherapy. Am J Health Syst Pharm. 2007 May 1;64(9 Suppl 5):S4-7. Halfdanarson TR, Jatoi A. Oral cancer chemotherapy: the critical interplay between patient education and patient safety. Curr Oncol Rep. 2010 Jul;12(4):247-52. Weingart SN, Brown E, Bach PB, Eng K, Johnson SA, Kuzel TM, Langbaum TS, Leedy RD, Muller RJ, Newcomer LN, O'Brien S, Reinke D, Rubino M, Saltz L, Walters RS. NCCN Task Force Report: Oral chemotherapy. J Natl Compr Canc Netw. 2008 Mar;6 Suppl 3:S1-14.
coronary intervention (PCI). Clopidogrel is a
prodrug that requires hepatic bioactivation to an
active metabolite, primarily by CYP2C19.
CYP2C19*2 and *3 alleles are associated with the
risk of adverse cardiovascular events in both
homozygous and heterozygous patients.
Mega et al, performed a meta-analysis, which
included nine studies comprised of 9685 patients
with ACS to investigate the risk of major
cardiovascular outcomes among carriers of one
or two reduced-function CYP2C19 variants.
Overall, 26.3% of patients had one, and 2.2% of
patients had two CYP2C19 reduced-function
alleles. The authors have found a significant
increase in risk of composite endpoint for both
groups of patients (HR 1.55, 95%CI: 1.11–2.17 for
heterozygotes; HR 1.76, 95% CI 1.24–2.50 for
homozygotes), and higher risks of stent
thrombosis (HR 2.67, 95% CI 1.69–4.22 for
heterozygotes; HR 3.97, 95% CI 1.75–9.02 for
homozygotes)4.
FDA added a black box warning to clopidogrel
label to caution practitioners regarding
diminished antiplatelet effectiveness in poor
metabolizers 5. In patients with poor metabolizer
status, alternative therapies should be
considered. For instance, prasugrel and
ticagrelor are antiplatelet agents that do not
require activation by CYP2C19 enzyme.
Practical Issues Involved with Oral Cancer Chemotherapy (Continued)
(Continued on Page 12)
Pharmacogenetic Testing: Focus on Clopidogrel (Continued)
Washington Metropolitan Society of Health-System Pharmacists July 2012
12
However, one should keep in mind that these agents possess their own
specific contraindications and limitations of use.
Dose adjustments for patients with intermediate metabolizer status have
not been well established. A pilot study of heterozygous patients showed
that increased dose of 150mg/day of clopidogrel corresponded with
increased extent of platelet inhibition (measured by vasodilator-
stimulated phosphoprotein (VASP) index) in some patients; however,
clinical outcomes were not evaluated 6. Therefore, a recommendation of
increased dosing strategy is not currently supported.
Routine testing for CYP2C19 polymorphism is not required and therefore
not commonly practiced. The decision to perform CYP2C19 testing is up
to the individual physician and patient.
CYP2C19 genotyping tests are available from several commercial
laboratories, with price ranges around $500. The specimen is required to
be sent to centralized laboratory, and estimated turn-around time of the
results is 7 to 10 days 7, 8. However, in the setting of acute cardiovascular
event, such a delay in processing may result in an adverse clinical
outcome.
Rapid genetic test Spartan RX CYP2C19 has been recently developed to
provide fast CYP2C19*2 genotyping. It is a world’s first genetic bedside
test, which requires a cheek swab, performed by the nurse, with results
available in 1 hour 9. The test has sensitivity of 100% and a specificity of
99.4% compared with DNA sequencing. The usefulness of point-of-care
(POC) testing was evaluated in a prospective, randomized, proof-of-
concept trial (RAPID-GENE). 200 patients who were being treated with
PCI for ACS or stable angina were enrolled. The patients were
subsequently randomized after POC test results to prasugrel for
CYP2C19*2 carriers, or to standard therapy with clopidogrel. For
CYP2C19*2 carriers, treatment with prasugrel completely eliminated high
on-treatment platelet reactivity (HPR), whereas 30.4% of carriers
receiving clopidogrel had HPR at 1 week10. The test is currently approved
in Europe, and pending regulatory approval in the USA.
Save the Date
AHSP Midyear Registration Opens – July 12, 2012
2012 ASHP National Residency Preceptors Conference
August 16 - 18, 2012
Washington, DC
Annual WMSHP Fall Meeting
September 22, 2012
Chevy Chase, MD
Seventeenth Annual ASHP Conference for Leaders in Health-
System Pharmacy
October 15 – 16, 2012
Chicago, IL
ASHP Midyear Clinical Meeting
December 2 –6, 2012
Las Vegas, Nevada
Pharmacogenetic Testing: Focus on Clopidogrel (Continued)
Washington Metropolitan Society of Health-System Pharmacists July 2012
13
In conclusion, there are potential benefits of CYP2C19 genotype determination in patients
requiring clopidogrel therapy for ACS. Genotyping remains expensive, and results may not be
rapidly available. However, efforts should be made by clinicians to pursue testing in order to
minimize the risk of adverse cardiovascular events. Future opportunity of POC testing may
provide convenient and rapid results to guide therapy decision-making, and improve patient
outcomes.
References:
1. Amur S, Fruech F, Lesko L, et al. Integration and use of biomarkers in drug development, regulation and clinical practice: a US regulatory perspective. Clin Pharmacol Ther. 2011 Aug; 90(2):328-32.
2. Pharmacogenomic biomarkers in drug labels. Available from: http://www.fda.gov/drugs/scienceresearch/researchareas/pharmacogenetics/ucm083378.htm. Accessed June 2012.
3. Scott SA, Sangkuhl K, Gardner E, et al. Consortium guidelines for cytochrome P450-2C19 genotype and clopidogrel therapy. Clin Pharmacol Ther. 2011 Aug; 90(2):328-32.
4. Mega JL, Simon T, Collet JP, et al. Reduced-function CYPC19 genotype and risk of adverse clinical outcomes among patients treated with clopidogrel predominantly for PCI: a meta-analysis. JAMA. 2010 Oct 27; 304(16):1821-30.
5. Clopidogrel (package insert). Bridgewater, NJ: Bristol-Myers Squibb/Sanofi. Revised 12/2011.
6. Bonello L, Armero S, Ait MokhtarO, et al. Clopidogrel loading dose adjustment according to platelet reactivity monitoring in patients Carrying the 2C19*2 loss of function polymorphism. J Am Coll Cardiol. 2010 Nov 9; 56(20):1630-6.
7. List patient’s price. LabCorp Customer Service Representative. Verbal communication. May, 2012
8. List patient’s price. Quest Diagnostics Customer Service Representative. Verbal communication. May, 2012
9. Dowdall M. First bedside genetic test for personalization of antiplatelet therapy. Pharmacogenomics (2012) 13(7), 739–741.
10. Roberts JD, Wells GA, Le May MR, et al. Point-of-care genetic testing for personalization of antiplatelet treatment (RAPID GENE): a prospective, randomized, proof-of-concept trial. Lancet 2012; 379: 1705–11
Pharmacogenetic Testing: Focus on Clopidogrel (Continued)
Washington Metropolitan Society of Health-System Pharmacists July 2012
14
MEMBERS “PAPPARAZZI” SECTION
Washington Metropolitan Society of Health-System Pharmacists OPPharmactsNewsletter
July Issue 2012
WMSHP The UPS Store #0478
11006 VEIRS MILL ROAD, STE L-15 Wheaton, MD 20902
website: www.wmshp.org
MEMBERS “PAPARAZZI” SECTION
WMSHP Committees
Interested in becoming actively involved in WMSHP?
Join and participate in one or more of our Committees
Finance Legislative
Membership Programming (monthly meetings)
Nominations Publications (newsletters, website)
**Send email with interest to [email protected] **
Officers
President Leon Vandenberg (Acting President) 443.364.5561 [email protected] President-elect Leon Vandenberg (elected 2011) Secretary Monique Bonhomme 202.364.7613 [email protected] Treasurer John Pelosi 301.774.0644 [email protected] Board Members Olubunmi Momoh [email protected] Beatrix Lam [email protected] ASHP Delegates Mary Binghay Michael Edwards