p&t updateextended-release quetiapine, weight gain of at least 7% of body weight occurred in 10%...

16
Second Quarter 2014 Vol. XI, Issue 2 P&T Update Special Points of Interest: P&T Update-Formulary Addition/Deletion Policy and Procedures Update Pharmacist Prescribing Authority Impact of CMS readmission Reduction Program on Pharmacy New Bill Allows EMTs to Administer Naloxone Metronomic Therapy: Potential Alternative or Adjunct to Conventional Chemotherapy Stress Ulcer Prophylaxis in the ICU: PPIs Riskier than H2RAs Pediatric Hypertension EDITORS: Andre Emont, Pharmacy Director Victor Pardo, Operations Manager Michael Chu, Clinical Pharmacy Manager Nishat Faruqui, Clinical Pharmacist Helen Horng, Clinical Pharmacist Polly Jen, Clinical Pharmacist Tyler McCamish, Clinical Pharmacist Formulary Addition/Deletion 1. Lacosamide (Vimpat®) – formulary addition Lacosamide is an anti-epileptic medication that is FDA approved for adjunctive treatment of partial onset seizures in patients 17 years or older. – Formulary addition of lacosamide not deemed necessary at this time. 2. Regadenoson (Lexiscan®) – formulary addition-approved Regadenoson is an A2A adenosine receptor agonist used as a pharmacologic stress agent in radionuclide myocardial perfusion imaging. – Formulary addition of regadenoson approved with restrictions to patients with mild-moderate reactive airway disease and underlying cardiac arrhythmias. 3. Homatropine hydrobromide (Isopto® Homatropine) 2% and 5% Ophthalmic drops - discontinued by the manufacturer. Formulary deletion-approved 4. Scopolamine hydrobromide (Isopto® Hyoscine) ophthalmic drops discontinued by manufacturer. Formulary deletion-approved 5. Inhaled Mannitol (Aridol ®) – Formulary addition – approved The Committee reviewed the formulary addition request for inhaled mannitol (Aridol®) indicated for the assessment of bronchial hyperresponsiveness in patients 6 years of age or older that do not have clinically apparent asthma. 6. Methacholine (Provocholine®) - Formulary Deletion – approved 7. Chemotherapy Formulary Deletions – approved The following medications were recommended to be deleted from the formulary by the Oncology Subcommittee due to low usage or no usage: chlorambucil 2mg po tab mercaptopurine 50mg tab etoposide 50mg po cap thioguanine 40mg tab lomustine 10mg, 40mg and 100mg capsules 8. Bupivacaine liposomal injection (Exparel®) – denied Bupivacaine liposomal injection in a long-acting formulation of an amide local anesthetic FDA approved for postsurgical analgesia. Formulary addition not deemed necessary at this time. 9. Nitroprusside Injections – approved Line extension addition for nitroprusside 50mg/2mL and deletion of nitroprusside 50mg/mL, which is not commercially available, were proposed. Addition of 50mg/2mL and deletion of 50mg/mL – Approved 10. Multiple vitamin oral preparation for renal patients Pharmaceutical Care Division proposed line extension for Nephro-Vite® or generic at a cost of $0.08/dose; as well as deletion of Strovite® ($0.60/dose), Strovite Plus® ($0.89/dose), NephroCap® ($0.33/dose), Nephro-Vite Rx® ($0.12/dose), Berocca or any other vitamin B Complex plus C. Addition of Nephro-Vite® or generic onto UH formulary & therapeutic interchange for any renal MVI to Nephro-Vite® were approved 11. Esmolol 2500mg/10mL Deletion Pharmaceutical Care Division proposed formulary deletion of esmolol 2500mg/10mL injectable vials due to manufacturer discontinuing production of this strength. Deletion of Esmolol 2500mg/10mL inj. vials – Approved

Upload: others

Post on 01-Oct-2020

0 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: P&T Updateextended-release quetiapine, weight gain of at least 7% of body weight occurred in 10% of those receiving the active drug. Weight loss occurred in only 0.1-1% of patients

Second Quarter 2014Vol. XI, Issue 2

P&T Update

Special Points of Interest:• P&T Update-Formulary

Addition/Deletion

• Policy and Procedures Update

• Pharmacist Prescribing Authority

• Impact of CMS readmissionReduction Program onPharmacy

• New Bill Allows EMTs to Administer Naloxone

• Metronomic Therapy: Potential Alternative or Adjunct to ConventionalChemotherapy

• Stress Ulcer Prophylaxis inthe ICU: PPIs Riskier thanH2RAs

• Pediatric Hypertension

EDITORS:

Andre Emont,Pharmacy Director

Victor Pardo,Operations Manager

Michael Chu,Clinical Pharmacy Manager

Nishat Faruqui,Clinical Pharmacist

Helen Horng,Clinical Pharmacist

Polly Jen,Clinical Pharmacist

Tyler McCamish, Clinical Pharmacist

Formulary Addition/Deletion1. Lacosamide (Vimpat®) – formulary addition

Lacosamide is an anti-epileptic medication that is FDA approved for adjunctive treatmentof partial onset seizures in patients 17 years or older. – Formulary addition of lacosamidenot deemed necessary at this time.

2. Regadenoson (Lexiscan®) – formulary addition-approvedRegadenoson is an A2A adenosine receptor agonist used as a pharmacologic stress agentin radionuclide myocardial perfusion imaging. – Formulary addition of regadenosonapproved with restrictions to patients with mild-moderate reactive airway disease andunderlying cardiac arrhythmias.

3. Homatropine hydrobromide (Isopto® Homatropine) 2% and 5% Ophthalmic drops -discontinued by the manufacturer. Formulary deletion-approved

4. Scopolamine hydrobromide (Isopto® Hyoscine) ophthalmic drops discontinued bymanufacturer. Formulary deletion-approved

5. Inhaled Mannitol (Aridol ®) – Formulary addition – approvedThe Committee reviewed the formulary addition request for inhaled mannitol (Aridol®)indicated for the assessment of bronchial hyperresponsiveness in patients 6 years of ageor older that do not have clinically apparent asthma.

6. Methacholine (Provocholine®) - Formulary Deletion – approved

7. Chemotherapy Formulary Deletions – approvedThe following medications were recommended to be deleted from the formulary by theOncology Subcommittee due to low usage or no usage:

chlorambucil 2mg po tab mercaptopurine 50mg tabetoposide 50mg po cap thioguanine 40mg tablomustine 10mg, 40mg and 100mg capsules

8. Bupivacaine liposomal injection (Exparel®) – deniedBupivacaine liposomal injection in a long-acting formulation of an amide local anestheticFDA approved for postsurgical analgesia.Formulary addition not deemed necessary at this time.

9. Nitroprusside Injections – approvedLine extension addition for nitroprusside 50mg/2mL and deletion of nitroprusside50mg/mL, which is not commercially available, were proposed. Addition of 50mg/2mLand deletion of 50mg/mL – Approved

10. Multiple vitamin oral preparation for renal patientsPharmaceutical Care Division proposed line extension for Nephro-Vite® or generic at acost of $0.08/dose; as well as deletion of Strovite® ($0.60/dose), Strovite Plus®($0.89/dose), NephroCap® ($0.33/dose), Nephro-Vite Rx® ($0.12/dose), Berocca orany other vitamin B Complex plus C. Addition of Nephro-Vite® or generic onto UHformulary & therapeutic interchange for any renal MVI to Nephro-Vite® were approved

11. Esmolol 2500mg/10mL DeletionPharmaceutical Care Division proposed formulary deletion of esmolol 2500mg/10mLinjectable vials due to manufacturer discontinuing production of this strength. Deletionof Esmolol 2500mg/10mL inj. vials – Approved

Page 2: P&T Updateextended-release quetiapine, weight gain of at least 7% of body weight occurred in 10% of those receiving the active drug. Weight loss occurred in only 0.1-1% of patients

Policies and Procedures/Floor Stock Update1. 707-400-108 Resuscitation Equipment Checks &

Exchanges – Policy RevisionThe policy is revised to include two Cardiac Cathlabkits under emergency boxes. One kit will bemaintained in the Cardiac Cathlab and other will bemaintained in the Pharmacy Department forexchange, once the former is used/expired. Thisrevised policy incorporates updates in content andlocation of code carts at University Hospital. Thereare currently 28 pediatric code carts and 55 adultcode carts.

2. 707-600-166 Labeling Medications,Medication Containers, and Other Solutions inthe Perioperative and Other Procedural Settings– Policy Revision The policy is revised to specifythat the circulating nurse/physician/scrub personmust verify that any IV admixture is not prepared formore than one hour prior and is used within 24hours of the preparation (unless an earlier expirationtime is recommended by the manufacturer).

3. 707-600-154 Decontamination, Surface Testingand Air Flow Testing – Policy Revision Surfacetesting and air flow testing policy were submittedfor member review and approval.

4. 707-800-205 PharmacyCleaning: IV Room,Anteroom & Buffer Area –New Policy This new policydelineates the new pharmacy IVroom cleaning and testing P&P.

5. IV Medication AdministrationGuideline – Revision and Annual ApprovalRevised to includeadministration of argatroban onall the hospital units, clevidipineby Anesthesia in the OR settingonly, dobutamine and dopamine instepdown/telemetry units at a rate

not exceeding 10mcg/kg/min and 5 mcg/kg/minrespectively in addition to the critical care/ ACU/EDsettings as a continuous infusion.

6. 706-100-340/707-600-147 RadiopharmaceuticalDelivery and Management – Policy RevisionThe policy is revised to reflect thatradiopharmaceutical delivery personnel will beaccompanied by a Radiology Technologist for afterhours/holiday deliveries.

7. 707-800-103 Multidose Vial policy - PolicyRevision The policy is revised to reflect that theterminology ‘beyond use date’ will be replaced with‘Use by date’ for the expiration dating of the IVmultidose vials once opened.

8. 707-500-121 Labeling & Dispensing of VincaAlkaloids for IVPB Administration – Policy RevisionThis revised policy incorporates October-December2013 ISMP quarterly action agendarecommendation on appropriate preparation ofvinca alkaloids. Vinca preparations should bedispensed in a IVPB in addition to other preventivemeasures that we currently observe, including notordering Vinca preparations on the same ordersheetas intrathecal chemotherapy, not dispensing Vincapreparations with any intrathecal chemotherapy, andnot permitting Vinca preparations in a patient carearea until lumbar puncture or any intrathecaladministration is complete.

9. 707-500-122 Automatic Therapeutic Exchange –Policy Revision This revised policy

incorporates the renal MVI automaticinterchange to Nephro-Vite® or its

generic.

10. 707-600-118 IntravenousAdmixture Service – Policy

Revision This revised policyincorporates updated change in the

pharmacy IV Admixture service.

2

Page 3: P&T Updateextended-release quetiapine, weight gain of at least 7% of body weight occurred in 10% of those receiving the active drug. Weight loss occurred in only 0.1-1% of patients

3

Antipsychotics & Weight Gain: Issue of Non-compliance

One of the most prevalent side effects that encouragesnon-compliance in antipsychotic medications is thesignificant weight gain that occurs. A decline in self-esteem and a negative body image forces the patientsto halt their use of antipsychotics. In a clinical trial ofimmediate-release quetiapine for all indications studiedin adults, a weight gain of at least 7% of body weightoccurs in 8-23% of the patients. In clinical trials forextended-release quetiapine, weight gain of at least 7%of body weight occurred in 10% of those receiving theactive drug. Weight loss occurred in only 0.1-1% ofpatients taking the medication.1 A medication that iseven more known for the side effect of weight gain isolanzapine. In multiple clinical studies, it was found thatolanzapine in combination with other medications, suchas lithium or valproate, increased weight significantly. Ina long term mono-therapy study, the percentages ofpatients who gained at least 7%, 15%, or 25% of theirbaseline weight were 64%, 32%, and 12%,respectively.2

According to a 2011 report by SUNY Medical Center,patients often gained anywhere from 4 to 37 lbs.3 Amoderate amount of weight gain can result inpermanent discontinuation of the medication. Manykinds of anytipsychotics, including Zyprexa®, and someother antidepressant, block activity at theneurotransmitter called 5HT2C, which has been provento be a trigger for increased eating behavior and obesityin mice.3 Other types of antipsychotics act on theneurotransmitter beta-3 adrenergic receptors in the fattytissue, which converts the fat into energy.3

Physicians have discovered that prescribing amedication that counteracts the mechanism of action ofthe antipsychotic would be the best option to preventweight gain. Medications such as metformin andtopiramate are often used to help patients maintain orlose weight. Obesity is a pandemic problem and mustbe avoided in order to prevent other co-morbidities. Thephysician should work with his/her patient to find apermanent solution that all parties can feel comfortablewith and is easy to implement to avoid non-adherence.Unfortunately, the only way to completely halt theweight gain, without a drastic change in one’s lifestyle,is to taper and then discontinue the medication. For apsychologically unstable person who relies on themedication to maintain a sufficient quality of life,stopping the medication would not be an option. All inall, weight gain is a minor but a significant side effect. Ifthe benefits outweigh the risks, then the medicationshould be continued and an alternate method to loseweight should be considered.

References:1. “Quetiapine: adverse effects.” Clinical Pharmacology.

http://clinicalpharmacology-ip.com/Forms/Monograph/monograph.aspx?cpnum=798&sec=monadve&t=0 20 May 2014.

2. “Olanzapine: adverse effects.” Clinical Pharmacology<http://clinicalpharmacology-ip.com/Forms/Monograph/monograph.aspx?cpnum=769&sec=monadve&t=0 0> 20 may 2014

3. Palmer, Roxanne. “How Antidepressants and Antipsychotics CauseWeight Gain.” International Business Timeshttp://www.ibtimes.com/how-antidepressants-antipsychotics-cause-weight-gain-1043724 20 May 2014

Contributed by:Donia Abdelazeem, Pharm. D Candidate 2017, St John’s University

Page 4: P&T Updateextended-release quetiapine, weight gain of at least 7% of body weight occurred in 10% of those receiving the active drug. Weight loss occurred in only 0.1-1% of patients

Treatment of Allergic RhinitisAllergic rhinitis is an IgE-mediated condition in

response to allergens in the environment, such aspollen, various insects, and animal dander. Patients maypresent with either seasonal rhinitis, perennial rhinitis, orepisodic rhinitis. The symptoms of allergic rhinitis mayseem benign, but they may exacerbate symptoms ofother respiratory tract diseases, such as asthma, if notmanaged appropriately.

To understand the drug methods used to treatallergic rhinitis, it is important to understand thepathophysiology of allergic rhinitis itself. When anantigen enters the nasal cavity for the first time, it isprocessed by lymphocytes, which in turn produce IgE.After secondary exposure, IgE will interact with theantigen and thereafter bind to mast cells, in turnreleasing inflammatory mediators such as histamine andleukotrienes. These mediators stimulate nasalvasodilation, increased vascular permeability, and theaccumulation of fluids in the nasal mucosa. From thesephysiologic effects give rise to the symptoms of allergicrhinitis: rhinorrhea, nasal congestion, sneezing, and alsoconjunctivitis. The initial onset of symptoms is known asan “immediate phase reaction”, whereas a “late-phasereaction” may also occur some 4-6 hours later, asinflammatory cells then begin to create their ownchemical mediators. There are currently six classes ofdrugs that are approved for allergic rhinitis, many ofwhich are now available over-the-counter (OTC). Theseagents should be chosen after consideration of the typeand severity of each patient’s symptoms.

Nasal steroids are often used as first line agentsdue to their potency against symptoms of allergicrhinitis, as well as for their activity against the earlyand late phase reactions. These agents act byreducing inflammatory mediators and chemotaxisin the nasal mucosa, but maximum effects may notbe seen for several weeks. Thus, if patients sufferfrom seasonal symptoms, they should be counseledto take these agents several weeks before the startof the season where their triggers are most common.Patients should also be properly instructed on howto use the inhalers, by inserting the device into thenasal cavity, aiming it toward the eye on theipsilateral side of the face, and pressing the actuatorat the same time as inhalation. Recently, newerformulations have been made to reduce side effectsof burning, itching, and epistaxis after use.

Antihistamines are also one of the mainstays oftreatment, however they are less potent that steroids.Antihistamines should be taken before allergen exposurefor maximal benefit, however tolerance does developover long-term use. Patients should be counseled toavoid use of alcohol and other CNS depressants, as wellas other OTC products that may contain antihistamines.Currently, second generation antihistamines arepreferred over first generation agents, such asBenadryl®, because of reduced somnolence.

Nasal decongestants act as agonists of thesympathetic nervous system, primarily causingvasoconstriction to reduce vascular swelling. Theseagents are predominantly OTC, and come as oral andintranasal formulations, but the latter dosage formcauses dependence and rebound congestion after 3-5days of use. Caution should be exercised if patientssuffer from hypertension and if they are taking anymedications for blood pressure. Mast cell stabilizerswork by preventing the initial release of mediators frommast cells, but they are not as effective as the otheragents and must be dosed 3-4 times daily for anytherapeutic effect. Montelukast, a leukotriene receptorantagonist, now recently OTC, is primarily useful forseasonal allergic rhinitis. Ipatroprium bromide is the onlyanticholinergic approved for use in allergic rhinitis, andmay prove useful in drying secretions, but may alsocause epistaxis as a result of nasal dryness.

(Continued on page 5)

4

Page 5: P&T Updateextended-release quetiapine, weight gain of at least 7% of body weight occurred in 10% of those receiving the active drug. Weight loss occurred in only 0.1-1% of patients

5

Tables from Surk DK. American Family PhysicianAllergic Rhinitis Clinical Practice Guidelines (below)

References:

1. Sur DK, Scandale S. Treatment of Allergic Rhinitis. Am FamPhysician. 2010;81(12):1440-1446

2. Wallace DV, Dykewicz MS, Bernstein DI, et al. The diagnosis andmanagement of rhinitis: An updated practice parameter. J AllergyClin Immunol 2008; 122(2):S1-S84. Available from:

http://www.aaaai.org/practice-resources/statements-and-practice-parameters/practice-parameters-and-other-guidelines-page.aspx

3. May JR, Smith PH, Allergic Rhinitis. In: Dipiro JT, Talbert RL, Yee GC,et al., eds., Pharmacotherapy: principles and practice. 7nd ed. NewYork: McGraw-Hill 2008: 1565-1575.

Contributed by:Warren Moore, Pharm.D. Candidate 2015, Rutgers University

Page 6: P&T Updateextended-release quetiapine, weight gain of at least 7% of body weight occurred in 10% of those receiving the active drug. Weight loss occurred in only 0.1-1% of patients

6

Introduction of Computer Provider Order Managementon Medication Error Minimization

Before thetechnologicaladvancement of the21st century,medication errorswere more thanprevalent in theUnited States healthsystem. In 2000, theInstitute of Medicine(IOM) reported asmany as 98,000patient deaths due tomedication errorsalone. In the past,

physicians had hand written or verbally communicatedtheir medication orders to pharmacists. Unfortunately,these orders were often incorrectly transcribed vianurses or pharmacy staff members due to reasons suchas use of non-standard abbreviations, poor illegibility,etc. Finally in 2007, the Institute of Medicine (IOM)recommended use of a computerized provider ordermanagement interface that dramatically changed thehealth care system.1

With features to warn clinicians of drug allergies,adverse drug reactions, drug interactions, teratogenicityand more, Computer Provider Order Management(CPOM) marks a revolutionary advancement in patientsafety capitalization. Not only does it provide importantreminders to physicians, but also it suggests alternativetherapies due to complications. It can check drugdosages against patient’s physical parameters,laboratory parameters and past medical histories andwarn physicians of any potential issues. Besides servingas an informational drug database, CPOM alsominimizes order forgery and fraud by using electronicsignature codes, ID scanners and fingerprint readers toverify physician identification. It can also limit providersto types of orders based on his or her scope of practiceand privileges. Furthermore, the CPOM software greatlyimproves order entry efficiency, which is an ongoingtopic addressed in every hospital. 2,3,4

Although the introduction of CPOM is a sound steptowards medication error minimization, it does presentits own risks and disadvantages. The installation of

computers and programming of software in largehospitals can be expensive and time consuming. Amajority of staff members would need to be educated onusing the new software. Frequent alerts and warningscan interrupt work flow. Additionally repeated overridesof these messages can lead to unconscious mistakes andimportant warnings to be accidently ignored.2,4

Nevertheless, IOM published studies have shownCPOM implementation to reduce rates of medicationerrors by over 80%, and reduce medication error relateddeaths by over 55%. Prescription ordering errors are thelargest identified source of preventable hospitalmedication error,and CPOM has donea great jobaddressing this issue.Not only has itsignificantlyimproved patientsafety, but also itenhanced both theefficiency of orderentry and orderverification. Today,both the CMS andCDC are pushing forfurther CPOMimplementation inhospitals acrossAmerica.1,2

References:1. Committee on Quality of Health Care in America. To Err is Human:

Building a Safer Health System. Washington, DC: National AcademyPress; 2000.

2. Hatfield, Mark D., Rodney Cox, Mhatre Shivani K., W. Perry Flowers,and Sansgiry Sujit S.. "Impact of Computerized Provider Order Entryon Pharmacist Productivity." Hospital pharmacy May 2014: Volume49, Number 5; Pages 458-465. Print.

3. Hoey, Patricia, Nichol W. Paul, and Robert Silverman. "ComputerizedProvider Order Entry." American Society of Health-SystemPharmacists, 30 Sept. 2008. Web. 10 June 2014.<http://www.ashp.org/DocLibrary/Bookstore/P886/P886Chapter-01.aspx>.

Payne TH, Hoey PJ, Nichol P, et al. Preparation and use of pre-constructed orders, order sets, and order menus in a computerizedprovider order entry system. J Am Med Inform Assoc. 2003;10(4):322–329.

Contributed by:Weihao Xie, Pharm.D. Candidate 2016, St. John’s University

Page 7: P&T Updateextended-release quetiapine, weight gain of at least 7% of body weight occurred in 10% of those receiving the active drug. Weight loss occurred in only 0.1-1% of patients

7

In the modern health care systems, where drugtherapy is the most common intervention, access to theright medication for the right patient in a timely manneris paramount. While improvements have been made toprescribing practices, primarily through the use ofefficient information technology, many patients fromrural areas, long-term care facilities, and those recentlydischarged from hospitals continue to encounterdifficulty accessing prescription medications.2 Currentpractices do not meet patients’ needs in terms of cost-effective, timely, and convenient access to prescriptionmedications. The most common healthcare providerthat patients visit is the pharmacist. Thus, pharmacistsare the logical choice to facilitate ease of access tomedications via prescribing rights.

Pharmacists in New Mexico, Montana, NorthCarolina, North Dakota, and California have beengranted “mid-level practitioner” status (MLP),permitting them to obtain DEA registration numbers.Additionally pharmacists have established CollaborativeDrug Therapy Management agreements withphysicians. These agreements allow pharmacists toinitiate drug therapy under the supervision of aphysician.3,5 To qualify for the Pharmacist ClinicianCertification and sub-sequently apply for prescriptionwriting privileges and a DEA number, New Mexicopharmacists must undergo a substantial amount ofadditional education. This includes diagnosis andphysical assessment training equivalent to what isrequired for physician assistants.3

Advanced Practitioner Pharmacists decrease costs forboth patients and the U.S. health care system overall.On average $37,200 is saved per month by advanced

Pharmacist Prescribing Authority

practitioner pharmacists, which covers the cost of theservices provided by the pharmacists.6 Despite thesebenefits, there are still obstacles in implementingprograms that allow pharmacists to help prescribe underCollaborative Drug Therapy Management withphysicians. Some of these obstacles includereimbursement challenges, patient acceptance andawareness, and proper planning and implementation.The benefits provided by pharmacists for patient careoutweigh the costs of incorporating these programs intoregular practice.

References:1. "FDA Proposal to Allow Pharmacists to Prescribe Some Drugs Sparks Swift

Rebuke From AAFP -- AAFP News -- AAFP." FDA Proposal to AllowPharmacists to Prescribe Some Drugs Sparks Swift Rebuke From AAFP --AAFP News -- AAFP. N.p., 02 May 2012. Web. 16 June 2014.<http://www.aafp.org/news/government-medicine/20120502pharmprescribing.html>.

2. Nissen, Lisa. "Pharmacist Prescribing." Medscape. American Journal ofHealth-System Pharmacy, 2011. Web. 16 June 2014.<http://www.medscape.com/viewarticle/754689>.

3. "Is Prescribing the Next Step in the Evolution of Pharmacy?" ASHPInterSections RSS2. American Society Health-System Pharmacists, 15 May2012. Web. 16 June 2014.<http://www.ashpintersections.org/2012/05/is-prescribing-the-next-1.step-in-the-evolution-of-pharmacy/>.

4. Gorn, David. "Pharmacist Scope-of-Practice Bill Now Law." CaliforniaHealthline. N.p., 03 Oct. 2013. Web. 16 June 2014.<http://www.californiahealthline.org/capitol-desk/2013/10/pharmacist-scope-of-practice-bill-now-law>.

5. Gebhart, Fred. "California Gives Pharmacists Prescribing Clout overControlled Substances." Drug Topics. N.p., 13 Dec. 2004. Web. 16 June2014. <http://drugtopics.modernmedicine.com/drug-topics/news/california-gives-pharmacists-prescribing-clout-over-controlled-substances?page=full>.

6. Murawski, Matthew, Kristin R. Villa, Ernes J. Dole, Timothy J. Ives, DaleTinker, Vincent J. Colucci, and Jefferey Perdiew. "Advanced-practicePharmacists."Medscape. American Journal of Health-System Pharmacy,2011. Web. 16 June 2014.<http://www.medscape.com/viewarticle/754690>.

Contributed by:Raj Kalaria, Pharm. D. Candidate 2016, Rutgers University

Page 8: P&T Updateextended-release quetiapine, weight gain of at least 7% of body weight occurred in 10% of those receiving the active drug. Weight loss occurred in only 0.1-1% of patients

8

Metronomic Therapy: Potential Alternative or Adjunct to Conventional Chemotherapy

Conventional chemotherapy regimens are cyclic andrely on administering maximum tolerable doses ofcytostatic or cytotoxic drugs. This approach necessitatesa period of rest and recovery for the patient’s immunesystem and can eventually contribute to thedevelopment of resistance. Additionally, patients mustdeal with debilitating side effects and/or inadequatetherapeutic results. Metronomic chemotherapy, which

involves the administration of continuous, low doseagents, has become an experimental treatment option.It has been shown to be less toxic and at least aseffective in treating certain cancers, especially whenused in combination with other targeted therapies.

Metronomic therapy uses an antiangiogenic approachto cancer therapy through various mechanisms. Thedestruction of endothelial cells that form the lining ofnew blood vessels prevents tumors from growing.1

Immune system activation involves inhibition of TREGcells and maturation of tumor-infiltrating dendritic cellsby certain drugs such as cyclophosphamide andpaclitaxel, respectively. The induction of senescence in

tumor cells is also a theorized mechanism by whichmetronomic therapy can have effects.2 Metronomictherapy regimens could include anti-cancer drugs incombination with non-cytostatic or cytotoxic drugs.2 Forinstance, one studied regimen included fenofibrate, aPPARα agonist with some anti-angiogenic effects, andcelecoxib, a COX-2 inhibitor with anti-inflammatory andanti-angiogenic properties, as part of a five drugregimen to treat children with recurrent or progressivecancer.3 Thalidomide, etoposide and cyclophosphamiderounded out the oral drugs given as metronomictherapy with weekly chemotherapy. COX-2 inhibitorsaffect apoptosis, can increase intracellularconcentrations of doxorubicin, and can dosedependently reduce the development ofadenocarcinomas.2 Similarly, the effect of metformin onsignaling pathways involved in cancer growth is anothercurrent area of discussion.2

Many early stage clinical trials have been conductedsince the metronomic approach was proposed andtested in animals years ago. The largest trials, includingalmost 500 patients total, involved advanced breastcancer patients and showed metronomic therapy as aneffective approach when used alone or in combinationwith bevacizumab, trastuzumab or letrozole.4 Otherstudies presenting promising results involve metronomicregimens for ovarian cancer, hormone-resistant prostatecancer, as a salvage therapy for relapsed or refractorymultiple myeloma, recurrent non-Hodgkin's lymphoma,recurrent malignant glioma and glioblastoma, and headand neck cancers. Phase III trials have not yet beenconducted in the United States, but one Japanese phaseIII study showed an increase in overall survival inpatients with lung adenocarcinomas when metronomictherapy was used as an adjunct to tumor resection.4

Although patient survival is not always significantlyprolonged, tumor stabilization and overall response inrefractory or relapsed cancer are reasons for optimism.Still, current findings are inconclusive as not all trialshave yielded promising results. Once more definitiveevidence is established, metronomic therapy could findits place in clinical settings. It could perhaps be reservedfor specific instances, such as treating more indolent,

(Continued on page 9)

Page 9: P&T Updateextended-release quetiapine, weight gain of at least 7% of body weight occurred in 10% of those receiving the active drug. Weight loss occurred in only 0.1-1% of patients

9

slow growing tumors that allow for more time for thepatient or as salvage therapy.

Although efficacy of metronomic therapy is not fullyestablished, it was designed to minimize toxicity. Themajority of associated side effects, such as nausea,vomiting, and neutropenia are low grade in scale. Itmust be taken into account, however, that current datadoes not include a large number of patients, and thecombination with various targeted drugs can changethe toxicity profile of typical regimens. Prolongedmetronomic therapies may lead to high levels due toaccumulation of these drugs. This could theoreticallyresult in secondary leukemia or resistance to thetherapy.2,4 Additionally, caution must be used whentreating children because of the role of angiogenesis ingrowth, even if tumor mechanisms differ from naturalphysiologic mechanisms. Despite these concerns, thetolerability of metronomic regimens has beendocumented.

Metronomic chemotherapy is currently experimentaland requires further investigation. Essential facets needto be determined including the number and type of

agents, dosing and administration strategies, andbiomarkers and other instruments for patient selectionand stratification. This is especially necessary due topatients’ differing responses based on tumor type. Still,several clinical trials have exhibited its potential efficacyas part of combination, adjuvant, or salvage therapy forcertain cancers. As cancer continues to be a prevalenthealth issue worldwide, the study of new, innovativeapproaches to chemotherapy, such as metronomicchemotherapy, is critical to improving patient care.

References:1. National Cancer Institute. A New "Target" for Chemotherapy?

[Updated: 27 June 2006, Accessed: 11 June 2014]. Available from:http://www.cancer.gov/aboutnci/ncicancerbulletin/archive/2006/062706/page4.

2. Mross K and Steinbild S: Metronomic anti-cancer therapy – anongoing treatment option for advanced cancer patients. journal ofCancer Therapeutics and Research 2012, 1:32http://dx.doi.org/10.7243/2049-7962-1-32.

3. Robison NJ, Campigotto F, Chi SN, et al. A phase II trial of a multi-agent oral antiangiogenic (metronomic) regimen in children withrecurrent or progressive cancer. Pediatr Blood Cancer. 2014 Apr;61(4):636-42.

4. Pasquier E, Kavallaris M, André N. Metronomic chemotherapy: Newrationale for new directions. Nat Rev Clin Oncol. August 2010;7:455-465.

Contributed by:Uzma Ahmed, Pharm. D. Candidate 2016, Rutgers University

Metronomic Therapy: Potential Alternative(Continued from page 8)

Impact of CMS Readmission Reduction Program on Pharmacy

In attempts to reduce the readmission rate forpreviously hospitalized patients, the Centers forMedicare and Medicaid Services (CMS) is in the processof implementing its Hospital Readmission ReductionProgram (HRRP). Starting in October of 2012, CMS hasdefined a readmission as an admission to any hospitalwithin 30 days of discharge.2 Readmission to hospitalswithin 30 days occurs in approximately 19.6% ofMedicare patients.1 This frequency increases to 34%when the time frame is expanded to 60 days.1 In 2004,this translated into a cost of roughly $17.4 billion forhospital readmissions.1 As of now, the only diagnosesthat the HRRP applies to are acute myocardial infarction(AMI), heart failure (HF), and pneumonia (PN).2 Theconditions reviewed under the HRRP are set to expandin 2015 to also include acute exacerbations of chronicobstructive pulmonary disorder (COPD), total hip

arthroplasty (THA), and total knee arthroplasty (TKA).2

Therefore, high rates of readmission for any of thesediagnosis related groups will drastically affect a hospital’sfinancial standing.

With the importance of reducing hospitalreadmissions rising, an emphasis on patient counselinghas also grown. A study that looked specifically atcongestive heart failure patients found a significantdecrease in readmissions when patients receivedcounseling. After comparing the results from the twotreatment arms, those who received counseling andthose who did not, there was an absolute reduction of13.2%.3 This reduction translated into a cost of carereduction of $307 per patient per month.3 According tothe recently updated American College of Cardiology

(Continued on page 10)

Page 10: P&T Updateextended-release quetiapine, weight gain of at least 7% of body weight occurred in 10% of those receiving the active drug. Weight loss occurred in only 0.1-1% of patients

10

Clinical Pharmacist Care in the Surgical Setting

The role of pharmacists is increasing in the ever-changing medical field. Patient care is becoming muchmore team based, and pharmacists have growing

influence in determining appropriate medicationtherapies. This is especially the case in the surgicalsetting, one of the most hands-on areas of patient care inthe hospital. While the unique skills and knowledge ofpharmacists in the actual operating room might not befully recognized, they are utilized significantly inpresurgical and post-surgical care.

Studies have shown an improvement in patient careand reduction of postoperative discrepancies due toclinical pharmacist interventions in surgery pre-admissionclinics. Dr. Olavo A. Fernandes and his colleagues atToronto General Hospital conducted a study thatcompared the number of postoperative medicationdiscrepancies between a control group that receivedstandard care and a group that received preoperative,pharmacist-led interventions.1 A postoperativemedication discrepancy is defined as “any medicationclarification related to home medications that was made

Foundation/American Heart Association (ACCF/AHA)heart failure guidelines, there is a substantial decrease inunplanned emergency admissions and readmissions forpatients that were counseled.4 This resulted in theACCF/AHA including patient discharge counseling in theheart failure guidelines.4 Similar recommendations havebeen made in guidelines for both acute myocardialinfarction and community acquired pneumonia.5,6

As the Affordable Care Act continues to grant moreUnited States citizens with health insurance, the cost ofhealth care is inevitably going to increase. Additionally,each year the primary care physician shortage increasesand leaves a larger gap in patient care that must beaccommodated. Ultimately, as the cost of health carerises, preventing unnecessary expenditures, such ashospital readmissions, will become the responsibility ofall health care professionals. Being the “drug experts” ofthe health care world gives pharmacists the expertise tolead the medication reconciliation sessions and lead tothe improvement in patient care outcomes and qualityof life.

References:1. Jencks SF, Williams MV, Coleman EA, et al. Rehospitalizations

among patients in the Medicare Fee-for-Service Program. N Engl JMed. 2009;360:1418-1428.

2. Centers for Medicare & Medicaid Services. Readmission ReductionProgram. [Updated: 30 April 2014, Accessed: 9 June 2014].Available from: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Readmissions-Reduction-Program.html.

3. Rich MW, Beckham V, Wittenberg C, et al. A multidisciplinaryintervention to prevent the readmission of elderly patients withcongestive heart failure. N Engl J Med. 1995;333:1190-1195.

4. Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline forthe management of heart failure: a report of the American Collegeof Cardiology Foundation/American Heart Association Task Forceon Practice Guidelines. Circulation. 2013;128:e240–327.

5. O’Gara PT, Kushner FG, Ascheim DD, et al; American College ofCardiology Foundation/American Heart Association Task Force onPractice Guidelines. 2013 ACCF/AHA guideline for themanagement of ST-elevation myocardial infarction: a report of theAmerican College of Cardiology Foundation/American HeartAssociation Task Force on Practice Guidelines. Circulation.2013;127:e362–e425.

6. Mandell LA, Wunderink RG, Anzueto A, et al. Infectious DiseasesSociety of America/American Thoracic Society ConsensusGuidelines on the Management of Community-AcquiredPneumonia in Adults. CID. 2007;44(supplement):S27- S72.

Contributed by:Alexander Mozeika, Pharm.D. Candidate 2016, Rutgers University

Impact of CMS Readmission Reduction(Continued from page 9)

(Continued on page 11)

Page 11: P&T Updateextended-release quetiapine, weight gain of at least 7% of body weight occurred in 10% of those receiving the active drug. Weight loss occurred in only 0.1-1% of patients

11

during the postoperative period” such as prescribingwrong drugs and dosages, or even inappropriateness ofrestarting home medications.1 Standard care involvednurses at the pre-admission clinic who obtainedmedication histories of the patients from their surgicalpreadmission clinic or occasionally over the phone. Theintervention group involved pharmacists gathering acomprehensive medication history through interviewingthe patient, assessing the patient’s current homemedication regimen, and generating a preprinted,postoperative medication order form for preoperativehome medications to reduce discrepancies ofmedications. The results of this study show that 41 outof 202 (20.3%) patients had at least one discrepancy inthe intervention group compared to 86 out of 214(40.2%) patients in the standard care group who had atleast one discrepancy.1 This is a significant reduction inmedication discrepancies due to the involvement of aclinical pharmacist in a pre-admission clinic.

A specific example where a clinical pharmacist isessential in the surgical setting would be in the bariatrictreatment process. With obesity being a major cause ofconcern for the population, bariatric surgeries arebecoming more prevalent.2 In preoperative care, thepharmacist has an important role in identifying andassessing many physiological factors (i.e weight, cardiacoutput, levels of serum lipoproteins, cholesterol, etc.) inorder to properly recommend appropriate doses ofmedications.2 They are also involved in creatingpreoperative protocol which provides correctprophylactic treatments for patients heading intosurgery.2 The role of a pharmacist in postoperative carealso determines the outcome of the bariatric surgery.Postoperative medication management is crucial for apatient’s successful recovery from the surgery. Thisincludes recommendations on the best medications togive directly after surgery, as well as making sure theroutes of administration of these medications are theeasiest for the patient. As the patient’s conditionimproves, so will many of his or her physiological factorssuch as blood pressure and glucose levels. Thepharmacist should be aware of this and make theappropriate recommendations to the patient’sphysicians.2

The importance of clinical pharmacist care in thesurgical setting is becoming more recognized andsought after. Surveys were taken of approximately 70nurses on the surgery wards of hospitals in Canadaunder the Capital Health domain nine months beforeand after the implementation of clinical pharmacist carein general and gastrointestinal surgery wards.3 Many ofthese nurses pointed out that the addition of clinicalpharmacists had a positive impact on their own rolesand responsibilities as nurses.3 At least 85% of nursessurveyed indicated that the clinical pharmacists’ caremet or exceeded their expectations.3 An observationalstudy conducted by the same coordinator as the nurses’survey shows clinical pharmacists’ impact onpostoperative care not only significantly reduced theamount and severity of adverse drug events, but alsocut additional costs for the patient and the hospital.4 Inthe study, the pharmacists made 1097 interventions insix months.4 A quarter of these interventions held a 40%or greater chance of preventing an adverse drug event.4

The pharmacists’ interventions avoided an additional867 days in the hospital for surgical patients.4

Overall, the importance of clinical pharmacist care inthe surgical setting cannot be understated. Theknowledge and skills that they bring to the health careteam are necessary and instrumental to patient care.Hospitals and other health care service providers shouldlook to utilize pharmacists and their understanding ofmedications to expand the range of care and safety ofpatients who undergo surgery.

References:1. Kwan Y, Fernandes OA, Nagge JJ, et al. Pharmacist Medication

Assessments in a Surgical Preadmission Clinic. Arch Intern Med.2007;167(10):1034-1040. doi:10.1001/archinte.167.10.1034.

2. Motylev, A. (2008), The Operating Room Pharmacist and BariatricSurgery. Us Pharm. 2008;33(12):HS19-HS27.

3. Chevalier, B. and Neville, H. L. (2011), Evaluating clinical pharmacyservices on a surgical patient-care area: a nurses' satisfactionsurvey. International Journal of Pharmacy Practice, 19: 61–69. doi:10.1111/j.2042-7174.2010.00076.x

4. Neville, H. L., Chevalier, B., Daley, C., Nodwell, L., Harding, C.,Hiltz, A., MacDonald, T., Skedgel, C., MacKinnon, N. J. and Slayter,K. (2014), Clinical benefits and economic impact of post-surgicalcare provided by pharmacists in a Canadian hospital. InternationalJournal of Pharmacy Practice, 22: 216–222. doi:10.1111/ijpp.12058

Contributed by:Justin Tamayo, PharmD. Candidate 2016, St. John’s University

Clinical Pharmacist Care in the Surgical Setting(Continued from page 9)

Page 12: P&T Updateextended-release quetiapine, weight gain of at least 7% of body weight occurred in 10% of those receiving the active drug. Weight loss occurred in only 0.1-1% of patients

12

Warfarin is a drug therapy that has been primarilylinked with the treatment or prophylaxis ofthromboembolic complications. Traditionally, warfarin isused as prophylactic treatment for the formation ofblood clots and embolisms, or can be used as treatmentto help prevent clots from becoming larger and lethal.

As an anticoagulant, its mechanism of action preventsthe overall clotting of the person’s vasculature.1

Treatment is generally monitored and adjusted bymeasuring a patient's International Normalized Ratio(INR), which utilizes prothrombin time, or a patient'sability to clot his or her blood. However, newobservational findings indicate that warfarin couldpotentially have other uses, such as for the treatment ofschizophrenia.2

Schizophrenia has, like other psychiatric illnesses,remained a highly controversial topic in terms of itscause and treatment. Various hypotheses of howschizophrenia develops are currently being studied. Oneof the most popular theories to its development involvesexcessive dopamine levels leading to abnormal neuronalactivity. Evidence that supports these claims are due tothe fact that many of the medications used to treatschizophrenia, such as haloperidol and clozapine,decrease dopaminergic levels by acting as dopaminereceptor antagonists. As a result, the reuptake ofdopamine is prevented, thereby decreasingschizophrenic symptoms.3

Warfarin: A Potential Drug Therapy for SchizophreniaDespite the popularity of the use of antipsychotics in

patients suffering from schizophrenia, these medicationsalso causes numerous side effects such as obesity,sedation, development of diabetes, agranulocytosis, etc.It has become clear through the use of thesemedications during the past few decades that a saferalternative is desired. Early studies have shown thatpatients who suffer from schizophrenia and receivewarfarin treatment show not only a decrease inschizophrenic symptoms, but also a decrease in theneed for antipsychotic medications. If further studiedand confirmed, the medical philosophy towards treatingschizophrenia and other psychotic disorders couldchange drastically.4

The findings were reported at an anticoagulationclinic located at the Federal University of Rio de Janeiroin Brazil where nearly 350 patients received long-termtreatment of warfarin for recurrent deep vein thrombosisor DVT at a time. Recently, of the patients receivingtherapy, five were found to also suffer fromschizophrenia. When the lead physician, Dr. SilviaHoirisch-Clapauch, reviewed their progress throughoutthe length of therapy, she found that all five not onlyshowed a decline in psychotic symptoms, but also nolonger displayed a need to continue any psychotropicmedications for approximately 2-11 years.4

The question now is to determine the mechanismresponsible for the possible link between the reductionof schizophrenia symptoms and warfarin. Research hasindicated that schizophrenic patients have a decreasedhippocampal volume.4 As a result, neuronal plasticity, orthe capability of the nervous system to respond andadjust to any environmental stresses, trauma, ordisruption of the normal homeostasis, is compromised.5

Further research in 2012 indicated that tPA, or tissueplasminogen activator, could be the common linkbetween treating thromboembolic events as well asincreasing neuronal plasticity and increasinghippocampal volume. The five patients treated in theBrazilian anticoagulant clinic were initially found to havelow levels of tPA. Further research has indicated that lowlevels of tPA can lead to abnormalities in the neuronalsystem such as poor conduction of dopamine.

(Continued on page 13)

Page 13: P&T Updateextended-release quetiapine, weight gain of at least 7% of body weight occurred in 10% of those receiving the active drug. Weight loss occurred in only 0.1-1% of patients

13

New Bill Allows EMTs to Administer Naloxone

Warfarin: A Potential Drug Therapy forSchizophrenia(Continued from page 12)

Additionally, it is hypothesized that low levels of tPA canlead to the improper cleavage of essential neurotrophicfactors found in the nervous system, thus interferingwith proper receptor mediated signaling. Althoughthese abnormalities are still being extensively studied,many researchers believe that they could be associatedwith schizophrenia. Levels of tPA are believed to risewhen a person is treated with warfarin as thismedication prevents thrombin-activatable fibrinolysisinhibitor from being activated. Thus, an increase in tPAis seen, lending further support to the idea that warfarincould be used to prevent symptoms of schizophrenia.4

If future studies indicate that warfarin and other drugscould be used to treat psychiatric diseases such asschizophrenia, the advantages to our patients would becountless. For example, it would significantly decreasemany of the adverse reactions and side effectsassociated with the drugs typically used to treat theseillnesses. Psychotropic drugs used to treat schizophrenia,such as clozapine, risperidone, and olanzapine, haveadverse effects such as increased risk of suicide,

significant weight gain, and the probability ofdeveloping diabetes. Should other safer treatmentsbecome available, a change in the treatment ofpsychiatric diseases could be seen.6 Despite all of thesepossible hypotheses, they remain just that - hypotheses.Until further research and clinical trials can beperformed, the traditional psychotropic drugs should beused to treat those with schizophrenia. However, itremains clear that there is still much to discover for thetreatment of psychiatric illnesses.

References:1. Warfarin. Medline Plus. Medline Plus Drug Information® [online].

2013. Accessed June 12, 2014.

2. Warfarin. Lexicomp. Lexicomp®Online [online] 2014. AccessedJune 14, 2014.

3. Howes OD, Kapur S. The Dopamine hypothesis of schizophrenia:Version III- the final common pathway. Schizophr Bull. 2009; 35(3):549-562.

4. Brauser D. Warfarin for long-term psychosis remission? AmericanPsychiatric Association's 2014 Annual Meeting. [updated 2014 may15; cited 2014 7 June]. Medscape.

5. Buschert V, Bokde ALW, Hampel H. Alzheimer Disease: cognitiveintervation-neuronal plasticity. Nat. Rev. Neurol. 2011.

6. University of Maryland Medical Center. Maryland: UNMC; [updated2013 June 27; cited 2014 June 10]. University of Maryland MedicalSystem.

Contributed by: Sherin Pathickal, Pharm. D. Candidate 2016, St.John's University

Overdose is now the leading cause of accidental deathin New Jersey, surpassing motor vehicle accidents, falls,and drowning.1 There were approximately 4,300 drug-related deaths in the state of New Jersey from2010-2013.2 One theory explaining the extensively highheroin overdose rates is that patients are gettingaddicted to prescription pain killers, such as oxycodone,that may be over prescribed. When these medicationsbecome too expensive or users cannot get theirprescriptions filled as frequently as they wish, they turnto illegal methods of purchasing drugs, such as heroin, amuch less expensive alternative. Overdose is also a bigproblem among teens that are trying heroin for the firsttime, as they are not fully aware of the dangers of itseffects.

In severe cases of opioid overdose, the amount oftime to get treatment is critical to the survival of theindividual. Some patients may not make it to the

hospital to receive the antidote, and unfortunately canpass away in their homes or in the ambulance. This pastMarch, Governor Christie signed a bill that will allowEMTs to administer the opioid antagonist, naloxone

(Continued on page 14)

Page 14: P&T Updateextended-release quetiapine, weight gain of at least 7% of body weight occurred in 10% of those receiving the active drug. Weight loss occurred in only 0.1-1% of patients

14

(Narcan®) to individuals who have overdosed.3

Naloxone, which can be administered as an injection,inhalation, or intranasal spray, can reverse the fatalrespiratory depression seen in those suffering from anoverdose.4 Previously, the only medications EMTs wereallowed to administer were short acting inhalers,epinephrine injections, and nitroglycerin. Now, they willbe able to administer all four of these time-critical andpotentially life saving medications. Additionally, TheGood Samaritan Emergency Response Act, which waspassed last year, allows witnesses of an overdose to notbe liable of criminal charges for drug possession if theycall for help.1 These laws raise the likelihood that apatient who has overdosed will get help sooner, thusincreasing his or her chance of survival.

Pharmacists can play a great role in the fight againstdrug abuse by utilizing the NJ Prescription DrugMonitoring Program (NJPMP). The NJPMP is a statewidedatabase that collects data on controlled drugprescriptions being dispensed in New Jersey.5 Thepurpose of the database is to reduce drug abuse. Whena pharmacist comes across a patient that has aquestionable prescription history, he or she isencouraged to assist the patient in seeking help.Pharmacists can also take on opportunities to educateteachers, parents, and youth in the community about

the dangers of drug abuse through various patientoutreach projects. Opioid-related deaths arepreventable. In addition to education, the recent actionsthat have been put in place would be able to prevent alarge scale of unnecessary mortalities. With theadditional 28,000 EMTs able to administer naloxone, theGood Samaritan Emergency Response Act, and NJPMP,the government hopes to see a decline in the number ofdeaths in New Jersey caused by heroin and other opioidoverdoses.2

References:1. Drug Policy Alliance. Governor Chris Christie to sign bill that would

prevent drug overdose deaths today at 2:00 pm. DrugPolicy.org.Retrieved June 3 2014.

http://www.drugpolicy.org/news/2013/05/governor-chris-christie-sign-bill-would-help-prevent-drug-overdose-deaths-today-200-pm

2. Barna, Maxwell. A Heroin epidemic is plaguing NJ. Vice News. April12, 2014. Retrieved June 9 2014.

https://news.vice.com/article/a-heroin-epidemic-is-plaguing-new-jersey

3. Office of the governor: Newsroom. Christie administration.www.state.nj.us. Grants waiver for EMTs to administer medicationin life threatening overdose situations. Retrieved June 3 2014.

http://www.state.nj.us/governor/news/news/552014/approved/20140321a.html

4. Naloxone. Lexicomp Online. Hudson, OH: Wolters Kluwer Health,inc; May 2013, Accessed June 3, 2014

https://online.lexi.com/lco/action/doc/retrieve/docid/patch_f/7338

5. New Jersey Division of consumer affairs. NJ Prescription MonitoringProgram (NJPMP). January 21, 2014. Retrieved June 9, 2014.

http://www.njconsumeraffairs.gov/pmp/

Contributed by:Joan Agbo, Pharm.D Candidate 2016, Rutgers University

New Bill Allows EMTs to Administer Naloxone(Continued from page 13)

Stress Ulcer Prophylaxis in the ICU: PPIs Riskier than H2RAsGastrointestinal

complications, suchas ulceration andbleeding associatedwith stress-relatedmucosal disease(SRMD), can occurin critically illpatients admittedto the intensive careunit (ICU). SRMD isan acute erosivegastritis, which maydevelop within 24

hours of admission to the ICU. A multitude of factors areinvolved in SRMD, including abnormal inflammatoryresponses, hypotension, hypovolemia, reduced cardiacoutput, and splanchnic hypoperfusion resulting inmucosal ischemia and damage.1

Stress ulcer prophylaxis is important for at-riskcritically ill patients to help protect against bleeding andminimize complications associated with SRMD.Independent risk factors for clinically significant bleedinginclude respiratory failure requiring more than 48 hoursof mechanical ventilation and coagulopathy. Otherpotential risk factors include recent major surgery,multiple trauma, severe burns, hepatic/renal disease

(Continued on page 15)

Page 15: P&T Updateextended-release quetiapine, weight gain of at least 7% of body weight occurred in 10% of those receiving the active drug. Weight loss occurred in only 0.1-1% of patients

15

Stress Ulcer Prophylaxis in the ICU: PPIsRiskier than H2RAs(Continued from page 14)

upon admission, sepsis, hypotension, neurologictrauma, multiple organ failure, and high-dosecorticosteroids. Prophylactic treatment should beinitiated in patients with at least 1 independent riskfactor or at least 2 other risk factors in the ICU setting.1,2

Pharmacologic agents used for stress ulcer prophylaxisinclude antacids, sucralfate, histamine 2 receptorantagonists (H2RAs), and proton pump inhibitors (PPIs).Antacids neutralize acidic contents of the stomach butare not recommended for use due to frequent dosingand increased risk of aspirationpneumonia and toxicity.Sucralfate forms a protectivebarrier between the mucosaand gastric acid in the stomachlumen but may reduceabsorption of medicationsconcomitantly administered.H2RAs inhibit histamine-stimulated acid secretion byreversible, competitiveinhibition of H2 receptorsinvolved with gastric secretionon parietal cells. PPIs inactivateH+-K+-ATPase, resulting inreduced gastric acid secretion.H2RAs and PPIs are the twomost common classes ofmedications administered in theICU for stress ulcerprophylaxis.1,2

Results from a new study recently presented at theSociety of Critical Care Medicine 43rd Critical CareCongress on January 11, 2014 indicate that critically illpatients exhibit a greater number of adverse eventswhen receiving PPIs compared to H2RAs. It is a commonpractice to administer a PPI or H2RA as prophylaxis inthe ICU to prevent bleeding that may result from stressulceration. PPIs are more often prescribed than H2RAs,often times being misused and overused. From July2009 to February 2013, medical records of patientsadmitted to a 54-bed medical-surgical ICU wereanalyzed. 14,280 patients received stress ulcerprophylaxis: 3,681 (43%) received a PPI and 4,881(57%) received a H2RA. 5,718 patients were excludedfor receiving acid suppression therapy prior to

admission, not receiving stress ulcer prophylaxis in theICU, or receiving both a PPI and a H2RA. However,researchers found that an indication for prophylaxis onlyexisted in 32.3% of patients who received a PPI and37.8% of patients who received a H2RA. Results alsodemonstrated an increased risk for adverse events inpatients being administered a PPI. Adverse events suchas gastrointestinal bleeding (4.7% vs. 1.1%) and 30-daymortality (6% vs. 3.7%) were significantly greater inpatients receiving a PPI than those receiving a H2RA (P-value < 0.0001). Other adverse events includeClostridium difficile infection (1.9% vs. 1.3%, P-value =0.02) and nosocomial pneumonia (0.29% vs. 0.26%,P-value = 0.8) for PPIs and H2RAs, respectively. It is

important to consider the adverseevent profiles demonstrated in thismost recent study and weigh boththe risks and benefits of thesemedications prior to use in theinpatient setting.3

Several factors must be taken intoconsideration when determiningwhich agent to use, includingassociated risk factors, theunderlying medical illness, and cost.In order to prevent a financial lossand overuse of medications,appropriate and cost-effective careshould be provided for all critically illpatients to ensure that patients areneither continued on prophylactictreatment once transferred out ofthe ICU, nor discharged on acidsuppression therapy without anidentifiable indication for use.

Collaboration among physicians, pharmacists, andnurses is important to minimize inappropriate use andmaintain optimal patient care with the least amount ofadverse events.4

References:1. Stollman N, Metz DC. Pathophysiology and prophylaxis of stress

ulcer in intensive care unit patients. J Crit Care. 2005;20:35-45.

2. ASHP Therapeutic Guidelines on Stress Ulcer Prophylaxis. Am JHealth-Syst Pharm. 1999;56:347-79.

3. Medscape.com: PPI Riskier Than H2 for Stress Ulcer Prophylaxis[Internet]. New York: WebMD LLC; c2014 [cited 2014 Feb 3].Available from: http://www.medscape.com/viewarticle/819303.

4. Farrell CP, Mercogliano G, Kuntz CL. Overuse of stress ulcerprophylaxis in the critical care setting and beyond. J Crit Care.2010;25:214-20.

Contributed by:Reshma Niyamathullah, Pharm. D. Candidate 2014, Rutgers University

Page 16: P&T Updateextended-release quetiapine, weight gain of at least 7% of body weight occurred in 10% of those receiving the active drug. Weight loss occurred in only 0.1-1% of patients

16

Pediatric HypertensionDiseases which are prevalent within the pediatric

population require distinct protocols for treatmentaccompanied by the utmost care and precision.Pediatric hypertension (HTN) is one disease state inparticular that has come to the forefront of medicalpractice in the United States over the past decade.Reasons for this include an increase in the prevalence ofcardiac abnormalities, improvements in diagnosing, anda rise in childhood obesity. It is estimated that 3% to5% of the pediatric population is currently affected bythis condition today.1

Children three years and older should have theirblood pressures checked via auscultation at each visit totheir healthcare provider, and measured viasphygmomanometer if the reading appears elevated.Childhood HTN is diagnosed based on average SystolicBlood Pressure and/or Diastolic Blood Pressure that is≥95th percentile on three or more consecutive officevisits. One’s blood pressure percentile is calculatedbased on his/her sex, age, and height.2

Pediatric HTN causes immediate harm to a child, butalso has implications on his/her health and well-being inthe future. Critical concerns for treating pediatric HTNinclude avoidance of some non-specific symptoms suchas headache, vertigo, nasal bleeding, nausea, andvomiting triggered by hypertensive urgency; andpreventing target organ insufficiency brought about byhypertensive crisis. Among the long-term consequencesof not treating pediatric hypertension are adult HTN,cardiovascular disease, and a linkage to insulinresistance.2, 3

Non-pharmacologic treatments such as lifestylemodifications can be effective at lowering bloodpressure and decreasing risks of cardiovascular disease.The Dietary Approach to Stop Hypertension (DASH) dietis commonly considered for pediatric patients (12months and older) with HTN. DASH encourages a dietregimen high in fruits and vegetables, non-fat dairyproducts, fiber, and low amounts of daily sodiumconsumption. Besides dietary modifications, weight lossfor overweight patients, and physical exercise for allpatients is recommended. Physical exercise can beperformed by the pediatric patient in numerous ways,such as participating in sports, walking, biking, andcompleting household chores.4, 5

Pharmacologic interventions appear to be the mosteffective forms of treating pediatric HTN. Since there islimited data regarding the long-term effects ofantihypertensive drugs on children’s growth and

development, clear-cut indications should be establishedbefore initiating therapy. These indications includesymptomatic HTN, secondary HTN, establishedhypertensive target-organ damage, and failure ofnonpharmacologic measures.2 Since all classes ofantihypertensive drugs have been shown to lower BP inchildren, it is the physician’s own judgment that dictateswhich medication to be used to initiate therapy. Nomatter which class of medication is selected, treatmentis initiated at the lowest recommended dose, andtitrated upward until the optimal BP is achieved. Afterthe highest possible dose has been reached, or if thepatient experiences adverse effects from the medication,a drug from another class is added onto the regimen.The most commonly prescribed anti-hypertensive drugsfor pediatric patients fall into four main classes:Angiotensin-Converting Enzyme Inhibitors, AngiotensinReceptor Blockers, Calcium Channel Blockers, and Beta-Blockers. Among the four classes, Angiotensin-Converting Enzyme Inhibitors have the most evidencesupporting their use in the pediatric population whentreating HTN.6 Although diuretics are commonly used totreat pediatric HTN, no large studies have beenperformed to date.

Pharmacists can play a large role in the detection andtreatment of pediatric HTN. They can record bloodpressure, promote healthy lifestyles, collaborate with thephysician to select the best course of treatment, andverify correct pediatric doses.5

References:1. Redwine KM, Acosta AA, Poffenbarger T, et al. Development of

hypertension in adolescents with prehypertension. J Pediatr.2012;160:98-103.

2. National High Blood Pressure Education Program Working Groupon High Blood Pressure in Children and Adolescents. The fourthreport on the diagnosis, evaluation, and treatment of high bloodpressure in children and adolescents. Pediatrics.2004;114:555-576.

3. Hypertensive crisis in children and adolescents. Skrzypczyk P,Roszkowska-Blaim M, Daniel M. Pol Merkur Lekarski. 2013Dec;35(210):379-84. Review. Polish

4. Torrance B, McGuire KA, Lewanczuk R, McGavock J. Overweight,physical activity and high blood pressure in children: a review ofthe literature. Vasc Health Risk Manag. 2007;3:139-149

5. Hylick, Ericka V., PharmD. "Pediatric Hypertension."USPharmacist.com. U.S. Pharmacist, 19 Feb. 2014. Web. 24 June2014. <http://www.uspharmacist.com/content/c/46726/>.

6. Meyers RS, Siu A. Pharmacotherapy review of chronic pediatrichypertension. Clin Ther. 2011;33:1331-1356.

Contributed by:Anthony Botte, Pharm.D. Candidate 2016, St. John’s UniversityTyler Valente, Pharm.D. Candidate 2016, St. John’s University