Layout

First Quarter 2012
P&T Update
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 Healthcare Research 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 Andre Emont
not dialyzable. Clinical trials have not identified significant differences in bleeding rates Pharmacy Director between rivaroxaban and enoxaparin or warfarin. It was recommended to restrict useof rivaroxaban to its FDA-approved indications. Victor Pardo
Operations Manager
Aflibercept (Eylea®) intravitreal injection – not approved Michael Chu
Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor recently approved Clinical Pharmacy 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 Helen Horng
Clinical Pharmacist
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 Polly Jen
has progressed during or within 6 months of treatment with a rituximab containing Clinical Pharmacist 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.
worked effectively • 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 of administration.
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.
preventive benefit.
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
Proton-pump inhibitors the stomach, thus (Protonix®, Nexium®, Prevacid®, etc.) have irritating effects to several uses in both the lining of the difficile is unable to hospitalized patients, survive at normal gastric they can be used for pH levels, but with the increased pH from PPIs, it is able to with corticosteroids, 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.
www.fda.gov/MedWatch/SafetyInformation. Accessed 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 1999; 56:347-379.
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 Sept:32(9): 1620-5 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 Operations Manager.
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 tobramycin. Hopefully, 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 Rutgers University 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.

Source: http://rbhs.rutgers.edu/uhnetweb/publications/pharmacy/pharmacy_news_1q12.pdf