First Quarter 2012
Vol. IX, Issue 1
Special Points of
P&T members discussed the formulary status of two tetanus toxoid, reduced diphtheriatoxoid and acellular pertussis (Tdap) vaccines: Adacel® and Boostrix®. Both vaccines are
• P&T Update-Formulary
currently maintained on the hospital formulary. The subcommittee agreed to keep
Adacel® as the formulary Tdap vaccine and remove Boostrix® from the hospitalformulary based on comparable clinical efficacy and cost effectiveness. Delete Boostrix®
• Policy and Procedures
from formulary – approved. Keep Adacel® as formulary item.
Rivaroxaban (Xarelto®) – formulary addition – approved
• ADR ME Agency for
Rivaroxaban is an oral factor Xa inhibitor that selectively blocks the active site of factor
Xa and does not require a cofactor (such as antithrombin III) for activity. It is FDA
Quality (AHRQ) harm scale
approved for prophylaxis of deep vein thrombosis (DVT) in patients undergoing kneeor hip replacement surgery and to reduce risk of stroke and systemic embolism in
• 1st Quarter 2012 Employee
nonvalvular atrial fibrillation patients.
Available formulary anticoagulants are subcutaneous enoxaparin (Lovenox®) and oralwarfarin; subcutaneous fondaparinux (Arixtra®) is non-formulary. Studies comparingrivaroxaban to enoxaparin for DVT prophylaxis following knee or hip replacementsurgery or warfarin for management of nonvalvular atrial fibrillation have demonstratedsimilar clinical outcomes.
Safety concerns with rivaroxaban were discussed, particularly the risk for majorbleeding events. There is no reversal agent for rivaroxaban induced bleeding, and it is
not dialyzable. Clinical trials have not identified significant differences in bleeding rates
between rivaroxaban and enoxaparin or warfarin. It was recommended to restrict useof rivaroxaban to its FDA-approved indications.
Aflibercept (Eylea®) intravitreal injection – not approved
Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor recently approved
for the treatment of neovascular (wet) age-related macular degeneration (AMD).
Formulary addition not deemed necessary at this time.
Bendamustine (Treanda®) – formulary addition – approvedBendamustine (Treanda®) is a DNA-alkylating agent that has been in use in Europe for
years to treat lymphoma. It was FDA approved in 2008 for treatment of chroniclymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin's lymphoma (NHL) that
has progressed during or within 6 months of treatment with a rituximab containing
Drug interaction precautions include use of CYP1A2 inhibitors (ex: ciprofloxacin) whichmay increase bendamustine concentration. CYP1A2 inducers (ex: carbamazepine) maydecrease bendamustine concentration.
(Continued on page 2)
P&T Update (Continued from page 1)
Amiodarone IV premixed bags (Nexterone® 150mg/
Fosaprepitant dimeflumine (Emend®) 150mg injection
100ml D5W – for code cart use only – approved
– line extension – approved
IV sotalol for code use only – line extension – approved
A line extension request for fosaprepitant dimeflumine
Formulary deletion of manufacturer discontinued
(Emend®) 150mg injection was presented. The formu-
medications – approved
lary addition of this medication was approved by the
1. Drotrecogin alpha (Xigris®) – Eli Lilly and Co. with-
drew it from market due to PROWESS-SHOCK study
Oseltamivir (Tamiflu®) 6mg/mL oral liquid – line
failing to show improved survival.
extension – approved. A line extension request for
2. Paregoric, camphorated opium tincture 2mg/5mL
oseltamivir (Tamiflu®) 6mg/mL oral liquid was
oral liquid. UH formulary option is tincture of opium
presented. The manufacturer recently changed the
10mg/mL oral solution
concentration of the oral liquid formulation from
3. Neomycin 125mg/5 mL oral liquid
12mg/mL to 6mg/mL
4. Oseltamivir (Tamiflu®) 12mg/mL oral liquid5. Thiopental sodium – all strengths
Tolvaptan (Samsca®) – Formulary addition – Not
6. Menthol (Cepacol®) 3mg lozenges
deemed necessary at present. Tolvaptan, a selective vasopressin receptor antagonists, is indicated for the
Automatic rounding of Hepagam® (hepatitis B immune
treatment of clinically significant hypervolemic and
globulin) dose. Rounding of the Hepagam®
euvolemic hyponatremia (serum sodium < 125mEq/L)
(Hepatitis B immuneglobulin) doses to utilize the lower
or less marked hyponatremia that is symptomatic and
vial size of the 5ml vial as outlined in the Automatic
has not corrected with other modalities such as water
Therapeutic Exchange policy was proposed to
restriction in patients with heart failure, liver failure,
eliminate wastage of this expensive medication –
Approval. Obtained from the liver transplant service.
Member provided recommendation to express doses
Menthol-benzocaine (Cepacol®) 3.6-15 mg lozenges –
both in units and ml.
line extension – approved
Alaris Smart Pump Changes PICU – IVF Guardrail
Ceftaroline (Teflaro®) – formulary addition –
changes, IVF bolus addition. Addition of IV fluid bolus
approved with restriction to ID service approval and
to the PICU library and Guardrail changes of IVF rate to
ID hospitalists. Ceftaroline is a new parenteral
hard max of 700ml/hr, soft min/max rates of 0.1ml/hr
cephalosporin antibiotic approved for the treatment of
and 101ml/hr, respectively Tham® (tromethamine) –
acute bacterial skin and skin structure infections and
Continuous infusion in adult ICU Addition of Tham®
community acquired pneumonia. It is the first
(tromethamine) to the adult ICU library.
betalactam antibiotic to have activity against MRSA andcommon community acquired respiratory pathogens.
831-200-057 Patient care incident reporting –
It has no activity against enteroccocus and
revision – approved
The patient care incident reporting policy was revised
to categorize medication errors and adverse drug
Lisinopril (Prinivil®) – formulary addition approved.
reactions using the AHRQ Harm Scoring System.
Ramipril (Altace®) – formulary deletion approved.
Lisinopril is an ACE inhibitor, approved for treatment of
The Agency for Healthcare Research and Quality
hypertension, improving survival post MI, heart failure.
(AHRQ) harm scale is intended: 1) to measure an
It has off label indications for prevention/treatment of
event's impact on a patient's functional ability,
diabetic nephropathy & retinopathy, proteinuria associ-
including quality of life; and 2) to be applied after any
ated with diabetic nephropathy.
attempt to prevent, reduce, or halt the progression ofharm to following the event. The AHRQ harm scale
Autosubstitution of benazepril, fosinopril and ramipril
simplifies a complex situation by collapsing into a few
to lisinopril incorporated into Automatic Therapeutic
scale points multiple dimensions, including 1) the
Exchange policy – Approval obtained from the Cardiology, Nephrology and Endocrinology services.
(Continued on page 3)
examination; laboratory testing including
P&T Update (Continued from page 2)
phlebotomy; and/or imaging studies). Distress/
duration of a given degree of harm; and 2) the severity
inconvenience since discovery, and/or expected in
of harm at any given point after the event episode.
the future as a direct result of event.
NEAR MISS (MILD)
5. Additional treatment: Injury limited to additional
1. Unsafe Conditions
intervention during admission or encounter and/or
2. Near miss (requires selection of one of the
increased length of stay, but no other injury. Treat-
ment since discovery, and /or expected treatment in
• Fail safe designed into the process and/or safeguard
future as a direct result of event.
• Practitioner or staff who made the error noticed and
6. Temporary harm: Bodily or psychological injury, but
recovered from the error
likely not permanent. Prognosis from time of assess-
• Spontaneous action by a practitioner or staff mem-
ber (other than person making the error) prevented
7. Permanent harm: Lifelong bodily or psychological
the event from reaching the patient.
injury or increased susceptibility to disease. Progno-
• Action by the patient or patient's family member
sis from time of assessment.
prevented the event from reaching the patient
8. Severe permanent harm: Lifelong bodily or
psychological injury or disfigurement that interferes
significantly with functional ability or quality of life.
REACHED THE PATIENT (MODERATE)
Prognosis from time of assessment.
3. No harm evident, physical or otherwise: Event
9. Death: Dead at time of assessment.
reached the patient, but no harm was evident.
All events classified as:
4. Emotional distress or inconvenience: mild and
Mild ADR/ME Event (1,2) Near miss event, No harm.
transient anxiety or pain or physical discomfort, but
Moderate ADR/ME Event (3,4,5) No harm/Moderate harm
without the need for additional treatment other
event. Severe/Significant ADR/ME Event (6,7,8,9) Per-
than monitoring (such as observation; physical
manent harm/Death event.
Deferiprone Approved by FDA for Iron Overload
Iron overload is responsible for the majority of the
deferoxamine. However, disadvantages of deferoxamine
morbidity and mortality associated with thalassemia.1
use include its route of administration (parenteral only)
When iron from transfused red blood cells can no longer
and adverse effects (increased risk of infection, infusion
be stored in reticuloendothelial macrophages, it is
reactions, growth retardation).2 Deferasirox is another
released into the plasma.2 There, transferrin binds the
chelating agent that has the advantage of an oral route
free iron. After transferrin is saturated, hepatocytes store
additional iron. If there is still excess iron after storage
The US Food and Drug Administration recently
by hepatocytes, free iron starts to exist in the plasma.
approved Ferriprox® (deferiprone) for the treatment of
Eventually, it enters and forms deposits in
iron overload from transfusions in patients with
cardiomyocytes, hepatocytes, anterior pituitary cells and
thalassemia and when current chelation therapy is
pancreatic beta cells. Free iron is also responsible for the
insufficient.3,4,5 The advantages to using this agent are
accelerated production of damaging free radical
its oral route of administration, its ability to remove
intracellular iron, and an increased ability to remove
Chelating therapy can double the life-expectancy of a
myocardial iron.3 Its limitations are its adverse effects,
patient with thalassemia.1 The mechanism of action
which include hepatotoxicity, agranulocytosis, and zinc
involves forming a complex with iron to allow for
excretion. The most commonly used agent is
(Continued on page 4)
Deferiprone Approved by FDA (Continued from page 3)
Engl J Med 2005; 353(11):1135-46.
2. Brittenham GM. Iron-Chelating Therapy for Transfusional Iron
Ferriprox® has not been evaluated in patients with
Overload. N Engl J Med 2011;364:146-56.
other forms of chronic anemia. There are also concerns
3. Ferriprox [package insert]. ApoPharma, Toronto, Canada. October
that the clinical data to support its use in this population
of patients are too weak. There have been calls to
4. Traynor, Kate. Deferiprone Approved for Iron Overload.
perform a prospective, randomized, controlled trial in
x?id=3619. Accessed [01/26/12]
order to demonstrate its efficacy.3,4,5 ApoPharma Inc.,
5. Waknine, Yael. FDA Approves Deferiprone for Iron Overload.
was granted an accelerated review of Ferriprox® under
the stipulation that the medication will be studied in
6. Ferriprox. Lexi-Comp, Inc. (Lexi-DrugsTM). Lexi-Comp, Inc.; January
sickle cell patients with iron excess due to transfusions.
Matthew Khowong, Pharm.D Candidate 2012, Rutgers University
1. Rund D, Rachmilewitz E. Medical Progress: Beta-Thalassemia. N
Metformin: An Emerging Anti-Cancer Agent
Recent studies have shown that the oral diabetic
At the cellular level, metformin activates AMP-
drug metformin (a biguanide), prescribed for the
activated Protein Kinase (AMPK), an energy sensor
treatment of Type 2 diabetes, is showing promising
involved in regulation of cellular metabolism. Its
signs of cancer treatment potential. This was first
dysregulation plays a role in diabetes and cancer
observed in epidemiological studies of diabetics who
initiation. Its anticancer effects are associated with
had cancer. In one of the largest studies of its kind, a
both direct (insulin independent) and indirect insulin-
team of researchers analyzed cancer risk among 8,000
dependent actions of the drug. Its indirect effects are
diabetics treated with metformin. Over a ten year
mediated by AMPK inhibiting transcription of
period, a 54% lower incidence of all cancers compared
gluconeogenesis genes in the liver to stimulate glucose
to the general population was observed. Not only did it
uptake in muscle, reducing fasting blood glucose
exert a major protective effect against cancer
levels. These insulin lowering effects play a major role
development, but a higher survival rate with those who
in its anticancer activity since insulin has mitogenic and
developed cancer of the lung, colon, and breast. Of
prosurvival effects. Tumor cells often express high levels
equal significance was the finding that the earlier the
of the insulin receptor, an indication of sensitivity to its
metformin regimen was initiated, the greater the
growth promoting effects.
The direct insulin independent effects originate by
In a recent study lead by Dr. Ryan J. Dowling of the
activation of AMPK, leading to inhibition of (mTOR)
Ontario Cancer Institute at University Health Network,
signaling in protein synthesis, a key integrator of
Canada, the epidemiological, preclinical, and clinical
growth factor and critical mediator of the
evidence all give a green light signal for metformin's
phosphatidylinositol-3 kinase/protein kinase
use as an anticancer drug.1,2 Other supportive studies
(P13K/PKB/AKT) signaling pathway, which is the most
involving 12,000 patients have shown metformin users
frequently deregulated molecular network in human
died of cancer 30% less than those taking sulfonylureas
(glyburide, glipizide). Of even greater significance,
Further clinical research is necessary to identify key
insulin users had a 90% greater death rate than
patient and tumor factors that govern metformin
metformin users in that study. Clinical analysis has
sensitivity, which is critical for the design of clinical
confirmed that diabetics have as much as a 40%
trials and identification of patients best suited for
increase risk of all cancer types compared to healthy
metformin treatment. For example, patients exhibiting
subjects. Elevated blood-sugar levels increase the risk of
hyperinsulinemia and tumors expressing the insulin
cancer including those of the kidney, pancreas, and
receptor LKB1 and TSC2 would benefit most from
(Continued on page 7)
Proton-Pump Inhibitors: Is Overuse in the Hospital
Environment Contributing to the Rising Incidence of
the stomach, thus
Prevacid®, etc.) have
irritating effects to
several uses in both
the lining of the
difficile is unable to
survive at normal gastric
they can be used for
pH levels, but with the
increased pH from
PPIs, it is able to
bacterium can survive
and H. pylori eradication.
on a moist or dry
A study at Massachusetts General
surface for up to 6
Hospital1 showed that stress-ulcer prophylaxis is the
hours, leading to its transmission throughout a
most common reason for proton-pump inhibitors in
hospitalized patients. However, several studies,
There is clinical data available to back-up the
including one by Gupta et al, showed that proton-
overuse of proton-pump inhibitors in hospital and
pump inhibitors were inappropriately prescribed in
outpatient settings.2,4,6-7 This increase in use of
73% of patients.4 Stress-ulcer prophylaxis is indicated
proton-pump inhibitors has coincided with the
for all patients that are mechanically ventilated, have a
increased incidence of Clostridium difficile, leading to
traumatic brain injury, coagulopathy, or major burn
its association with each other. It is also worth noting
injury. It is also indicated for intensive care patients
that antibiotic prescribing and hospital hygiene have
with multiple traumas, sepsis, acute renal failure, or
improved during this time, making this association
high-dose corticosteroids. Stress-ulcer prophylaxis is
even more likely.2
not recommended for general medical and surgical
In conclusion, over-prescribing of proton-pump
patients in non-ICU settings with fewer than two of the
inhibitors leads to patients being on unnecessary
previously mentioned risk factors.5 When seeing the
medication and increases the risk of Clostridium
limited indicated uses for proton-pump inhibitors, it is
difficile-associated diarrhea (CDAD). CDAD should be
easy to see how they can be overused in the hospital
considered for all patients taking PPIs who develop
setting. Gupta et al also noted that of the 73% of
diarrhea that does not improve. While this warning is
patients inappropriately prescribed proton-pump
not in package inserts, the FDA is working with
inhibitors, 69% were discharged on the medication;
manufacturers to make this a part of the drug labels.
80% were taking the medication three months afterdischarge and 50% after six months.4
Author: Tyler McCamish, PharmD
On February 8, 2012, the FDA released a Safety
1. Yachimski PS, Farrell EA, Hunt DP, Reid AE. Proton Pump Inhibitors
Watch to notify the public that the use of proton-pump
for Prophylaxis of Nosocomial Upper Gastrointestinal TractBleeding. American Medical Association. 2010; 170(9): 779-783.
inhibitors (PPIs) may be associated with an increased
2. Cunningham R and Dial S. Is over-use of proton pump inhibitors
risk of Clostridium difficile-associated diarrhea (CDAD).3
fuelling the current epidemic of Clostridium-difficile-associated
PPIs work by increasing the pH of the gastric acid in
diarrhea? Journal of Hospital Infection. 2008; 70: 1-6.
(Continued on page 6)
Proton-Pump Inhibitors: (Continued from page 5)
Updates for the Use of Hepatitis
3. U.S. Department of Health & Human Services: U.S. Food & Drug
B and HPV Vaccinations
Administration. Proton Pump Inhibitors (PPIs) – Drug Safety Com-munication: Clostridium Difficile-Associated Diarrhea (CDAD) Can
Hepatitis B Vaccine1-2
be Associated with Stomach Acid Drugs. February 8, 2012.
The Center for Disease Control and Prevention
(CDC) has released new recommendations for the use
4. Gupta R, Garg P, et al. Overuse of Acid Suppression Therapy in
hepatitis B vaccines (HBV) in adults with diabetes
Hospitalized Patients. Southern Medical Journal. 2010; 103(3):207-211.
mellitus. The Advisory Committee on Immunization
5. American Society of Health System Pharmacists. ASHP therapeutic
Practices (ACIP) came to this recommendation after a
guidelines on stress ulcer prophylaxis. Am J Health Syst Pharm
review showed that 25 of 29 outbreaks of HBV
infection in long-term-care facilities involved adults
6. Forgacs I, Loganayagam A. Overprescribing proton pump
inhibitors. Br Med J. 2008; 336:2-3.
with diabetes. The recommendation is for all previously
7. Walker NM, McDonald J. An evaluation of the use of proton
unvaccinated adults aged 19-59 with diabetes (type 1
pump inhibitors. Pharm World Sci. 2001; 23:116-117.
and 2) to be vaccinated against hepatitis B as soon aspossible after a diagnosis of diabetes is made. There isless data to support vaccinating adults over the age of60, so these patients are to be vaccinated at thediscretion of their physicians based upon theirlikelihood of contracting the virus. Adults with diabetesare more prone to liver disease and are twice as likelyto develop a chronic infection than people withoutdiabetes.
There has also been a recommendation for the
human papillomavirus (HPV) vaccine in boys. Therecommendation from the CDC suggests boys aged11-12 and those up to 21 that have not yet beenvaccinated, receive the HPV vaccine for a reduction inthe risk of genital warts and precancerous lesions andthe ability to pass HPV on to their partners. Gardasil® isrecommended for boys, as Cervarix® is only approvedfor females.
Author: Tyler McCamish, PharmD
1. Centers for Disease Control and Prevention. Use of Hepatitis B
Vac-cination for Adults with Diabetes Mellitus: Recommendationsof the Advisory Committee on Immunization Practices (ACIP).
Centers for Disease Control and Prevention. 2011; 60(50); 1709-1711.
2. Jellin JM. Vaccines. Pharmacist's Letter. 2012; 28(2): 8-9.
Metformin: An Emerging… (Continued from page 4)
In conclusion, the clinical safety, well-characterized
metformin therapy. Patients with normal circulating
pharmacodynamic profile, and low cost make met-
insulin levels and tumors lacking those insulin receptors
formin an ideal candidate as an anti-cancer agent.
would likely be unresponsive to the drug. The
challenge is predicting how non-diabetic patients will
1. Libby G. Donnelly LA, Dunman PT, Alessi DR, Moris AP, Evans JM.
respond to metformin and differentiating between its
New users of Metformin are at low risk of incident cancer: Acohort study among people with Diabetes. Diabetes Care, 2009
direct and indirect effects. Currently, a number of
clinical trials are underway including studies in
2. J.O Dowling, P Goodwin, V Stambolic,: Under-standing the
prostate, breast, endometrial and pancreatic cancer
benefit of Metformin use in cancer treat-ment. BMC Medicine2011, 9:33
patients. The National Cancer Institute of Canada
3. Duncan B.B Schmidt M, Metformin –Cancer Its role in
Clinical Trials Group is examining the effect of
epidemiology in Etiologic Research. Diabetes Care 2009 Sept:
metformin vs. placebo in 3,500 patients with early
stage breast cancer.6
4. Baron B.B, Yea H.C. Snyder CF et al. Long-term mortality in cancer
patients with preexisting diabetes mellitus: A Systematic Review
Significant renal disease (serum creatinine > 0.16
and meta analysis. JAMA 2008 Dec 17, 300(23) 2754-64
mmoles/L), hepatic disease, alcoholism, and condi-
5. Markman B, Atzuri F. Perez-Garcia J. Tadernero J, Baselja J.R. Status
of P13K inhibition and bio-marker development in cancer
tions associated with hypoxia (e.g. cardiac and
therepeutics Ann On-colgy 2010 21: 683-691
pulmonary disease, surgery) are contraindications to
6. Goodwin PJ, Stambolic V, Lemieux J. Chen BE Parulekar WR,
metformin use. Significant mortality can result with
Gelmon KA, Hershman DL, Hobday TJ, Ligibel JA Mayer IA,Pritchard KI, Whelan TJ Rastogi P., Shepherd LE: Evaluation of
drug-induced lactic acidosis. This is characterized by
metformin in early stage breast cancer: a modification of the
low pH in body tissues and blood considered a distinct
tradi-tional paradigm for clinical testing of anti-cancer agents.
Breast Cancer Res Treat 2011 215-220
form of metabolic acidosis. This potentially
Contributed by: Joseph Licata, RPH
fatal adverse effect can lead to life–threateningcomplications such as shock.
American Society of Health-System Pharmacists
(ASHP) House of Delegates 2012 - Mr. Andre Emont
Congratulations to Mr.
aspect of practice. Statements express basic
Andre Emont, RPh , MS,
philosophy, and guidelines (including what were
Director of Pharmacy for his
formerly called "technical assistance bulletins") offer
2-year term election by the
programmatic advice. Therapeutic position statements
New Jersey Society of
are concise responses to specific therapeutic issues, and
therapeutic guidelines are thorough, evidence-based
(NJSHP) to the American
recommendations on drug use. The House of Delegates
Society of Health-System
meets annually at the ASHP Summer Meeting, (this
Pharmacists (ASHP) House of
year in Baltimore) where it reviews policy proposals
that have been approved by the Board of Directors.
Mr. Emont is one of four
Most professional policies are initially drafted by ASHP
Councils or the Executive Committee of Sections and
delegates to represent New Jersey in such a capacity.
The House of Delegates is the ultimate authority over
Mr. Emont's dedication to the profession of
ASHP professional policies, which express the Society's
Pharmacy on all levels demonstrates the strength and
stance on important issues related to health-system
quality of Pharmacy leadership in New Jersey as well as
pharmacy practice and medication use. ASHP's
professional policies contain varying levels of detail.
Respectfully submitted by Michael Chu, Pharm.D.
Policy positions are short pronouncements on one
New Jersey Society of Health-System Pharmacists
(NJSHP) at Rutgers Pharmacy Career Day
As a call to duty, we diligently made our way to
responsibility to be an ally to students and help them
attend the Rutgers Pharmacy Career Day. This annual
navigate through these unusually difficult times. NJSHP
event hosted by the Ernest Mario School of Pharmacy
is uniquely positioned to accomplish this via the
takes place at the Busch Campus Student Center in
cumulative knowledge and expertise of its members. It
Piscataway, New Jersey. Historically, this event is heavily
is crucial to educate students and new graduates to see
attended by major corporations, hospital organizations
NJSHP not only as a source for CE credits but as an
and professional societies and this year was no
organization that can provide opportunities for
exception. This event provides NJSHP with the
professional growth through internships, mentoring and
opportunity to speak with pharmacy students of all
networking. The Rutgers Career Day offers NJSHP a
grade levels about their career options and opportunities
unique opportunity for this open dialogue.
available as members of NJSHP. This year's Career Day
NJSHP's participation in this event is crucial as we
has also addressed obstacles to students because of the
forge new relationships with those who will ultimately
economic uncertainties of today's job market.
be at the helm of our profession.
The current market environment strengthens our
Contributed by: Victor Pardo, Pharmaceutical Services
opportunity as a professional pharmacy organization to
show students that NJSHP has the unique ability and
Welcome Two New Pharmacists
Gwan Y. Jang, Pharm. D. obtained his doctor of
Neerav Vaidya, Pharm.D. is excited to start his career
pharmacy degree from St. John's University College of
at UMDNJ as a staff pharmacist. He earned his Doctor of
Pharmacy in May 2011 and was previously working in a
Pharmacy degree in May 2011 from the University of
community pharmacy. Outside work, he is a pianist for
the Sciences in Philadelphia. Outside of work, he enjoys
his church and a keyboardist in a worship band. He
going to the gym and spending time on outdoor
spends most of his time in church.
Aztreonam (Cayston®): the Second FDA Approved
Inhaled Antibiotic for Cystic Fibrosis
Cystic fibrosis is an autosomal recessive disease that
the market until recently with the FDA approval of the
primarily affects newborns of Northern European
second inhaled antibiotic, aztreonam lysine (Cayston®)
descent. Each year, about 1 out of 3,200 newborns are
in 2010. The pivotal clinical trial was a randomized,
diagnosed with this disease in the United States. In
doubleblind, placebo controlled, multicenter trial thatevaluated the use of inhaled aztreonam in cystic fibrosispatients for 28 days.
The study analyzed clinical improvement through
FEV1 values and quality of life via questionnairepertaining to respiratory symptoms. Clinicalimprovement in FEV1 values in the treatment group wasstatistically significant; however the difference was moreprofound among the pediatric patients than the adultpatients.5 From an adverse event perspective, inhaledantibiotics are not absorbed systemically, so the toxicityissues are less of aconcern; however,there are currently nostudies comparingaztreonam to
cystic fibrosis, there is a constant buildup of sputum in
tobramycin, so further
the lungs, which puts them at risk of infection and
studies are warranted
ultimately the devastating complications of the disease.
in assessing the efficacy
Over the past 30 years, the overall survival age has
data of aztreonam to
increased into the mid 30's due to the advancement in
research and improved medical treatments.1,2,3
the use of inhaled
The role of antibiotic therapy in the management of
antibiotics can improve
cystic fibrosis is to treat acute exacerbations of the
survival and quality of
infection caused by mainly the pathogen, Pseudomonas
life for cystic fibrosis
aeruginosa. The unique aspect of the antibiotic therapy
for cystic fibrosis is the utilization of the inhalation route
of administration. The rationale behind this formulation
is to better target the site of infection and decrease risk
of systemic toxicity.
3. Elborn JS, Shale DJ, Britton JR. Cystic fibrosis: current sur-vival and
According to the treatment guidelines established
population estimates to the year 2000. Thorax. Dec1991;46(12):881-5
by the Cystic Fibrosis Foundation, they are not for or
4. Flume PA, Mogayzel PJ Jr, Robinson KA, Rosenblatt RL, Quittell L,
against the use of concomitant inhaled and IV
Marshall BC; Clinical Practice Guidelines for Pulmo-nary Therapies
antibiotics due to the lack of sufficient evidence.
Committee; Cystic Fibrosis Foundation Pulmo-nary TherapiesCommittee. Cystic fibrosis pulmonary guidelines: pulmonary
Because these patients are on chronic antibiotic therapy,
complications: hemoptysis and pneumothorax. Am J Respir Crit
the issues of cost, toxicity, and resistance come into
Care Med. 2010 Aug 1;182(3):298-306.
consideration.4 Tobramycin (TOBI®) was the first
5. Cayston (aztreonam lysine for inhalation) package insert. Foster
City, CA: Gilead Sciences; 2010.
nebulized antibiotic (aminoglycoside) that was FDA
Contributed by: Regina Yoon, PharmD. Candidate of 2012,
approved in 1997. It has been the only one of its kind in
Department, but also the education of medical students,residents, and fellows, especially within the InfectiousDiseases Division. She has improved patient care anddeveloped strong inter- and intra-departmentalrelationships. One of the ID attending physicians stated"Polly has become a central member of the daily IDconsult service rounds. Her input regarding choice anddosing of antibiotics has become an integral componentof decision making. In areas where the data are
The Pharmacy Department
controversial, Polly frequently looks up relevant literature
is pleased to introduce
on the topic and contributes immensely to patient care.
another employee with the
Most of all, her affable, easy-going personality make her
Employee of the Quarter Award
extremely well-liked by everyone in the division." Polly
for the first quarter of 2012.
is a consummate professional. She is hard-working,
The Essential Piece Award this
dedicated, and tenacious in her ability to effect positive
time around goes to Polly Jen,
change at The University Hospital for the patients she
Pharm. D. BCPS, whom from
serves. Her calm demeanor and soft voice hide the true
day one has demonstrated to
warrior of healthcare within. She is a pleasure to work
be a remarkable employee
with and a great asset to our department. Congratulations
who continues to reveal her
Polly! Your enthusiasm and passion continue to motivate
abilities. Polly joined UMDNJ
in August 2009, and from that point on, the department
has been very fortunate to have her on the Clinical
Michael Chu, Pharm. D.
Pharmacy staff as an Infectious Diseases Specialist. Polly
Clinical Pharmacy Manager
has worked diligently to advance not only the Pharmacy
Welcome Two New Pharmacy Technicians
Jennifer Procell, CPhT, is thrilled to join UMDNJ as
David Narouz, CPhT, started as a staff pharmacy
the Pharmacy's newest pharmacy technician. She is
technician at UMDNJ in December of 2011. He is very
a graduate of The Cittone Institute and is currently
passionate about the profession, and has strong hopes
attending Middlesex County College, pursuing a degree
of continuing his journey to becoming a Pharmacist.
in Chemistry. Jennifer was previously employed with
David was one year shy of graduating from the
Walgreens Pharmacy and overall, brings over six years
College of Pharmacy in Egypt, and is taking this great
of experience. Outside of work, she enjoys physical
opportunity to increase his knowledge and practice of
fitness activities, reading and spending time with her
the pharmacy profession, while working at The
University Hospital, a teaching facility. Outside of work, David enjoys reading and traveling to differentcountries in order to enjoy new cultures.
División de Enfermería Servicio de Cirugía Cardiaca. Instituto Cardiovascular Programa de Educación al Paciente con Cardiopatía Guía Informativa Cirugía de Prótesis Valvular Guía informativa cirugía cardiaca-valvular Esta guía está pensada y elaborada para usted que se le ha
APPENDIX VI GENERAL HEALTH INFORMATION Preparing for Your Trip to Mexico Before visiting Mexico, you may need to get the following vaccinations and medications for vaccine-preventable diseases and other diseases you might be at risk for at your destination: (Note: Your doctor or health-care provider will determine what you will need, depending on factors such as your health and immunization history, areas of the country you will be visiting, and planned activities.) To have the most benefit, see a health-care provider at least 4–6 weeks before your trip to allow time for your vaccines to take effect and to start taking medicine to prevent malaria, if you need it. Even if you have less than 4 weeks before you leave, you should still see a health-care provider for needed vaccines, anti-malaria drugs and other medications and information about how to protect yourself from illness and injury while traveling. Be sure your routine vaccinations are up-to-date. Routine vaccines, as they are often called, such as for influenza, chickenpox (or varicella), polio, measles/mumps/rubella (MMR), and diphtheria/pertussis/tetanus (DPT) are given at all stages of life; see the childhood and adolescent immunization schedule and routine adult immunization schedule.