August 2014

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Co rp P or P io n at N be e gi Pr ns of on ile pa s g e

The Pharmacist’s News Source

pharmacypracticenews.com

Volume 41 • Number 8 • August 2014

Printer-friendly versions available online

in this issue OPERATIONS & MGMT

4 12

Collaborative care slashes 30-day readmission rates.

Patient navigators help smooth path from hospital to home.

POLICY

18

CMS eyes $5 billion boost to 2015 outpatient payments.

CLINICAL

34

Pediatric HIV “cure”

38 42

Pharmacogenomics gains traction.

suffers setback.

New device standards target deadly tubing misconnections.

TECHNOLOGY

45

Tips for boosting safety of chemotherapy e-prescribing.

Primary Immunodeficiency Considerations for Selection of Appropriate Replacement Ig Therapies See insert after page 10.

From ASHP Midyear:

Director charged as drug kingpin

Smaller Is Better For Cutting Costs Of Fluid Overload

Can 200K Oxycodone Pills Walk Out of Yourr Facility?

Las Vegas—Not only can fluid overload increase a patient’s risk for death, but it can add several days to their hospital length of stay (LOS) and more than $15,000 to the total health care cost, according to a study presented at the American Society of Health-System Pharmacists Summer Meeting (poster 18-T).

Fluid overload is a serious condition that can affect many organs and systems in a person’s body, including the heart, lungs and kidneys ((Hemodial Intt 2010;14:348-354). It also is associated with cardiac and renal dysfunction that can lead to a continuous treatment cycle to properly manage patient needs ((Pediatr Crit Care Med d 2014;15:131-138).

Researchers at Smiths Medical, a global provider of medical devices, conducted a study to determine the potential burden of illness of fluid overload and the resulting effect on

T

•

he recent arrest of a former New w York hospital pharmacy directorr for pilfering nearly 200,000 oxycodonee pills underscores the need for facilitiess to shore up their operations, makingg sure there are safeguards in place so thaat no one employee has enough power to o divert controlled substances and other in-demand medications, according to pharmacists skilled in preventing the criminal activity.

On July 8, Anthony D’Alessandro, former director of pharmacy services fo or Beth Israel Medical Center in New Yorrk City, was arrested and indicted for stealling and illegally possessing oxycodone, which he allegedly began diverting in 2009. The drugs carried a street value o off approximately $5.6 million, according to a statement from Bridget Brennan, New Yorrk City’s special narcotics prosecutor.

The indictment charged D’Alessandro o with operating as a major trafficker underr New York State’s Drug Kingpin Statute.

•

see FLUID OVERLOAD, page 42

Adjuvant ChemoRx Underused in LateStage Colon Cancer Chicago —Roughly one-third of patients with stage III colon cancer are not receiving the recommended adjuvant chemotherapy, according to a study presented at the 2014 annual meeting of the American Society of Clinical Oncology. Patient age and insurance status were among the reasons why some physicians skimped on the potentially life-prolonging treatment (abstract 3576).

•

see ADJUVANT, T page 32

see OXYCODONE, page 16 6

Ambulatory Pharmacy Faces Uphill Battle in Tracking Key Outcomes Dallas—As an expert told attendees of the American Society of Health-System Pharmacists’ (ASHP) inaugural Ambulatory Care Conference and Summit, “data talks.” Right now, however, ambulatory care pharmacists do not have enough of that tech chatter to “hang their hats on” and justify their salaries.

“If you’re a high-cost provider practicing in an ambulatory care setting, you need to demonstrate your value in terms of both cost and quality—and right now, pharmacists don’t have the kind of quality outcomes data

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Up Front 3

Pharmacy Practice News • August 2014

Infectious Disease Sofosbuvir-based regimen ‘a quantum leap’ forward

Combination Treatment Tames HIV/HCV Coinfection Chicago—Patients coinfected with HIV and hepatitis C virus (HCV) who received combination therapy with sofosbuvir (Sovaldi, Gilead) and ribavirin had high rates of sustained HCV virologic response 12 weeks after discontinuation of therapy, according to a recent study in the Journal of the American Medical Association.

The results are an encouraging development for the 7 million people worldwide who are thought to be coinfected with HIV and HCV, according to Mark S. Sulkowski, MD, a professor of medicine and medical director of the Viral Hepatitis Center at Johns Hopkins University in Baltimore.

“Hepatitis C is an important cause of morbidity and mortality among people living with HIV,” said Dr. Sulkowski, the lead investigator of the PHOTON-1 study.

In the open-label, nonrandomized uncontrolled study, researchers enrolled 223 U.S. patients with HIV/HCV through 34 centers ((JAMA 2014;312[4]:353-361).

They evaluated the rates of sustained virologic response (SVR, serum HCV <25 copies/mL) and adverse events after treatment with once-daily sofosbuvir (400 mg) and twice-daily ribavirin (dosage based on patient weight).

All HCV genotype 1 (GT 1) patients were treated for 24 weeks. GT 2 and GT 3 patients who were HCV-treatment naive received therapy for 12 weeks. GT

2 or GT 3 patients who had failed previous HCV treatment received therapy for 24 weeks. Among the treatment-naive patients, 76% with GT 1, 88% with GT 2 and 67% with GT 3 achieved SVR 12 weeks after stopping therapy. Among patients who had previously received treatment, 92% with GT 2 and 94% with GT 3 achieved SVR. Seven patients discontinued treatment due to adverse events, most commonly fatigue, insomnia, headache and nausea. No adverse effect on HIV disease or its treatment was observed.

A Tale of Two Viruses Dr. Sulkowski noted that combined antiviral regimens such as the one studied in the PHOTON-1 trial address a growing, potentially lethal trend in patients with HIV/HCV coinfection.

“In an era of highly effective antiretroviral therapy, we now see dramatically lower mortality rates due to HIV itself.

And in that context, we see the emergence of important comorbid conditions like HCV.” In such patients, he said, “we see a more rapid progression of liver disease due to hepatitis C, so HIV appears to accelerate the pace at which a patient will progress from minimal liver damage to cirrhosis.” Indeed, when one questions how HIV-infected patients are dying today, “the answer, in many parts of the world where highly effec-

tive HIV treatment is available, is liver disease due to HCV.” Whether the sofosbuvir/ribavirin regimen ultimately proves to be a magic bullet against HIV/HCV coinfection remains to be seen. But the preliminary results of the PHOTON-1 trial are a “quantum leap” forward for managing these challenging patients, according to Michael Saag, MD, a professor of medicine at the University of Alabama at Birmingham and director of the UAB Center for AIDS Research, who wrote an editorial in the same issue.

Dr. Saag noted, however, that the cost of the combination therapy renders it widely unaffordable. “The question [is] … how do we make HIV

care the most cost effective? This is important in HIV as more drugs go generic, but it is applicable to all areas of medicine,” he said. “We can’t afford to prescribe in the absence of consideration of cost of care.”

—Marie Rosenthal Dr. Sulkowski disclosed receiving research grants, personal and other fees from AbbVie, Bristol-Myers Squibb, Gilead, Indenix, Janssen, Merck and PIPI. Dr. Saag received personal consulting fees from Gilead, Merck, ViiV and Bristol-Myers Squibb and grants to the institution for clinical trials from Abbvie, BMS, Boehringer Ingelheim, Gilead, Janssen, Merck and ViiV. Gilead Sciences funded the trial.

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Volume 41 • Number 8 • August 2014 • pharmacypracticenews.com

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4 Operations & Management

Pharmacy Practice News • August 2014

Collaborative Care

Creative Solutions for Slowing Hospital Readmissions E

ver since the Centers for Medicare & Medicaid Services (CMS) began to reduce payments to hospitals for excessive readmissions last year, many health care professionals have been on a mission to seek out novel strategies to curb the rehospitalizations and also improve patient safety and satisfaction.

Several pharmacists and a nurse practitioner from two different hospitals recently shared their creative solutions to achieve these goals during a webinar sponsored by the Institute for Safe Medication Practices (ISMP).

Figure. Example of a medication card (partial view).

A Team Approach Anne Drolet, APN, CCRN, a nurse practitioner at the Cadence Physician Group, Central DuPage Hospital (CDH), a 300bed community hospital located outside of Chicago in Winfield, Ill., favors the team approach to lowering readmission rates. She and her colleagues developed a small patient pilot program several years ago in which advanced practice nurses (APNs) worked alongside physicians and pharmacists to review patient medication discharge lists. Each morning, she noted, the APN would collaborate with the physician during rounds to determine which patients may be ready for discharge. The APN would review the current electronic medical record (EMR), vital signs and all pertinent lab and test results. The patients’ medication list would be reviewed to determine such things as antibiotic therapy duration, core measure interventions and correction of medication reconciliation. The APN and the pharmacist would perform a joint review of the medications and make recommendations that were then discussed with the physician. The APN then documented the rationale for any changes to the current medication list under patient discharge instructions.

Ms. Drolet said she was surprised at the results of the program’s initiatives. “The difference we could make in reviewing medications together was very positive. In particular, it fostered collegial relationships through shared expertise between APNs and pharmacists,” she noted. “Then we’d go into the room and discuss the medication changes with the patient and family. They came away knowing there was such commitment to determining the appropriate medication list for their loved one.”

The pilot program worked so well that in November 2012, the APN/Pharmacy Quality Improvement Project team joined forces with CDH’s readmission strategy team on a larger study. In reviewing readmission data, 60 of the 634 patients included in the study were readmitted within 30 days of discharge.

This was a 27% reduction from preim-

plementation data. Of those readmitted, 18% were readmitted for a medicationrelated issue.

Ms. Drolet cited several factors that contributed to the success of the program. “APNs know the patients and all of the events that occurred throughout their hospital stay,” she said. For example, nurses can note in patients’ discharge instructions why particular medications were changed. “We’d place a simple statement such as: “Your aspirin was stopped because you have a bleeding ulcer,” she said. “Patients get so many discharge instructions, it provided the family with relief.”

The Pharmacist’s Perspective Imran Khan, PharmD, a clinical pharmacist who works with Ms. Drolet at CDH, offered further evidence of the program’s success during the ISMP webinar.

Dr. Khan analyzed the results of pharmacist interventions done as a result of medication reconciliations in 634 patients. He found that the top two reasons for the interventions were correction of medication reconciliation done by nurses or other health care providers (41%) and a reduction of unnecessary medications (18%). In the latter group, a typical intervention involved the prescribing of pain medications. “We asked why a patient was being discharged on four pain meds.

We determined which one was the most effective and best tolerated by the patient, and discontinued the others.”

The interventions addressed another frequent medication-related problem: “drug-bug” mismatches, where patients were discharged on antibiotics that were poorly matched to the organisms responsible for their infections, Dr. Khan noted.

He cited, as an example, “a patient with a urinary tract infection that was growing ciprofloxacin-resistant E. coli” who was discharged on ciprofloxacin. “We were able to correct the antibiotic.”

These interventions soon paid off. “We looked at 22 doctors who we worked with before and after the pilot,” Dr. Khan said.

“Their readmission rate fell from 14% in 2012 to 10% … a 27% reduction. Clearly, we’ve all learned from each other and improved our relationships.”

Medication REACH Program High readmission rates prompted Deborah Hauser, RPh, MHA, the network pharmacy director, outpatient services at Einstein Healthcare Network, in Philadelphia, to get involved in nonadherence issues several years ago. Ms. Hauser said a lack of basic health literacy—which she said affects more than one-third of all patients—was thought to be a contributing factor. To address the problem, she helped organize the Medication REACH Program at Einstein, which takes care of predominantly safety-net patients. During the ISMP webinar, she explained the REACH program as follows: R: Reconciliation. The medication list has to be correct.

E: Education that is patient-centered.

A: Access to care issues during transition must be resolved.

C: Counselingg that is comprehensive and continues post-discharge.

H: Healthy patients who are compliant with their medications at home are the goal.

Working closely with a multidisciplinary team, Ms. Hauser organized a discharge study in 2010 of adult patients on at least five medications. The team discussed the proper dosing and potential side effects of each drug with patients, and provided them with a pill organizer and medication leaflets. “We collected a large number of pill images to formulate a pictorial card,” she said. “Pictures are very effective in teaching [Figure].”

Ms. Hauser also noted that her team made sure that patients left with an acceptable medication they could take on their formulary. That process can be time-consuming and complicated.

“You need to work with social workers for the uninsured population and enroll your patients in assistance programs when needed.” Ms. Hauser said there

were a myriad of other access-to-care issues that her team dealt with, including lack of prescription benefit insurance, the need for prior authorization and issues with copays.

Comprehensive patient counseling is also key, she noted. Her team conducted counseling 72 hours and 30 days postdischarge. They reviewed medications with their patients, and answered their questions. Sometime during week 4, her team reached out to remind patients to refill their medications.

The 30-day readmission rate for patients in the REACH program was 10.6%, vs. 21.4% for patients without the intervention. “We were shocked at the improvement,” Ms. Hauser said.

New Pharmacy Positions Mariel Sjeime, PharmD, a transitionof-care pharmacist who works with Ms. Hauser at Einstein, spoke at the ISMP webinar about expansions and enhancements to the REACH program, including creating a discharge pharmacy. Einstein Apothecary provides all discharge patients with their first 30-day prescription, regardless of their insurance coverage. Dr. Sjeime said the revenue generated by the new pharmacy, along with a CMS-funded community care transitions grant, allowed the hospital to invest in several new positions: • Advanced pharmacy technicians coordinate the discharge process, obtain prescriptions, navigate accessto-care issues and identify patients who would benefit from additional pharmacy counseling.

• Patient navigators identify patients at high risk for readmission, educate patients on their disease state and make sure patients have a follow-up appointment with their primary care physician.

• Bridge care coordinators conduct home visits within 72 hours of discharge to make sure patients have everything they need at home, and conduct weekly follow-up phone calls for 30 days.

• Transition-of care-pharmacists follow patients throughout their hospital stay, beginning with medication reconciliation. They also provide discharge counseling, and ensure that prescriptions are filled using either Einstein’s discharge pharmacy or patients’ local pharmacy.

Dr. Sjeime said a commitment of resources to support the interventions was a major factor in the program’s success, “as well as to be constantly evaluating them and looking for opportunities to expand or enhance them.”

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6 Operations & Management

Pharmacy Practice News • August 2014

Ambulatory Care Heart failure patients benefit from interdepartmental effort

Improving Quality Scores and Care Transitions Christopher Zielenski, PharmD Clinical coordinator Boulder Community Health Boulder, Colorado

Table 1. Congestive Heart Failure Action Plan Symptom

Action

All Clear—Green Zone

Green Zone—Your symptoms are under control

NO shortness of breath NO swelling in the feet, ankles, legs or abdomen NO weight gain NO chest pain NO decrease in activity level

Continue taking your medications Continue following your low-salt diet Limit fluid intake to ____ per day Keep appointments with your doctor Increase activity level as able Continue taking your weight daily Discharge weight: _____ on ______ Target weight: ________

collaborative, multidisciplinary approach is effective in implementing a successful transitions-of-care program for patients with heart failure (HF).

Pharmacists can influence hospital utilization rates by identifying and resolving medication issues, as well as providing patient education at discharge, and following up with a telephone conversation post-discharge. We have shown that this approach can increase adherence, as well as decrease emergency department (ED) visits and subsequent hospitalizations.

Caution—Yellow Zone

Yellow Zone—Your symptoms show you may need a change in your medications

Emergency—Red Zone

Red Zone—Call your physician immediately

Background

Unrelieved shortness of breath Unrelieved chest pain Wheezing or chest tightness at rest Chest pain not relieved by nitroglycerin tablets if ordered Confusion or not being able to think clearly Extreme fatigue

CALL 911 Or Call your primary physician Primary physician: __________________________________ Physician phone number: ___________________________

Linda Radke, PharmD, BCPS Pharmacy clinical coordinator Salina Regional Health Center Salina, Kansas

Thea Todd, RN, BSN RN Abstractor, Quality Improvement Salina Regional Health Center Salina, Kansas

A

Recent legislation has changed how hospitals are reimbursed by the Centers for Medicare & Medicaid Services (CMS). Established with the Affordable Care Act in 2010, the Hospital ValueBased Purchasing program bases hospital reimbursement on select clinical process-of-care measure scores, including Heart Failure-1: Discharge Instructions.

Payments are based on scores related to performance and improvement.

Patient satisfaction and hospital readmission measures are included in reimbursement incentives. These scores are reported publicly on the Hospital Compare website (www.medicare.gov/hospitalcompare/search). They are important to hospital administrators because they not only affect reimbursements but may influence the decisions of prospective health care consumers. The intent of these laws is to reduce overall health care costs by improving quality of care and reducing preventable readmissions.

Promoting better clinical patient outcomes and more effective care transitions to reduce unnecessary readmissions can be achieved. Salina Regional Health Center (SRHC) in Salina, Kansas, sought to accomplish this by developing innovative best practice models aimed at reducing the risk for readmissions. We wanted to improve transitions of care through participation in the CMS Partnership for Patients initiative.

We evaluated strategies in the literature for identifying patients at risk for

Weight gain: 2-4 lbs OR ___ lbs in 1-3 days Weight gain: 3-5 lbs OR ___ lbs in 1 week More shortness of breath with activity More cough or wheezing More swelling in the feet, ankles, legs or abdomen Feeling more tired than usual Dizziness Increased number of pillows needed to sleep Need to sleep in chair Feeling sick

Call your physician and/or home health nurse Primary physician: __________________________________ Physician phone number: ___________________________ Agency: ____________________________________________ Agency phone: _____________________________________ Other instructions: __________________________________ _____________________________________________________ _____________________________________________________

Schumpert Sc u pe t C. C Agency ge cy for o Healthcare ea t ca e Research esea c and a d Quality Qua ty Web Site.

S te http://www.innovations.ahrq.gov/content.aspx?id=334. ttp //www ovat o s a q gov/co te t asp d 33 2007.

00 Accessed ccessed August ugust 2013.

03

readmission to design targeted interventions for this population.1,2 We identified patients diagnosed with acute myocardial infarction, HF, pulmonary embolism, pneumonia, stroke, and venous thromboembolism as being at high risk for readmission to SRHC and sought to develop a protocol for pharmacists to identify, educate, and provide timely follow-up for one of these high-risk patient populations to assess the potential effect on quality indicator measures and readmission rates. We created a pilot program targeting patients likely to have a primary diagnosis of HF at discharge. This group served as an excellent pilot population due to their high-risk status, complicated medication regimens, small relative population size, and localization in the cardiac care unit (CCU).1,3 In several studies, pharmacists demonstrated the ability to influence transitions of care and reduce 30-day readmission rates independently and as part of a collaborative health care team through education and follow-up, which are important to prevent adverse events (AEs) and unnecessary readmissions. Two Canadian studies found hospitalizations

often are complicated by AEs occurring after discharge.4,5 Medication counseling performed by a pharmacist before discharge with a medication reminder card and discharge summary for older inpatients improves adherence and patients’ medication knowledge, and reduces unplanned visits to physician offices and readmissions.6 Greater adherence and medication knowledge has been shown to decrease ED visits among HF patients.7 Pharmacists also have decreased hospital utilization rates by conducting follow-up phone calls.8 When these calls are made 2 days after patients are discharged from a general medical service, patient satisfaction with discharge medication instructions is higher, identification and resolution of medication-related problems are increased, ED visits are decreased, and pharmacists can recognize and refer patients when required to other health care providers.9 Another trial found that pharmacist medication counseling at discharge followed by telephone follow-up for patients discharged from a general medicine service identified and resolved unexplained medication discrepancies between preadmis-

sion and post-discharge medication lists, reducing the rate of preventable adverse drug events.10 Pharmacists also have identified unintended medication discrepancies and prescription errors during discharge counseling.11 Such discrepancies are associated with increased risk for 30-day hospital readmissions as described above.2

Methods A resident pharmacist shadowed team members participating in patient education and coordination of discharge processes to understand the challenges in meeting required elements of the HF-1 process of care measure. Inconsistencies and weaknesses in the transitions-of-care process were identified, including communicating to nursing staff which patients required HF education; determining who had responsibility for providing HF education; choosing educational materials to be provided; deciding how to document education given in the patient chart; and transcribing the written discharge medication reconciliation form into the

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8 Operations & Management

Pharmacy Practice News • August 2014

Ambulatory Care

TRANSITIONS

Table 3. CMS Discharge Instruction Scores for Salina Regional Health Center by Quarter

continued from page 6

electronic patient discharge instruction form. A role for pharmacists was developed addressing these issues.

Stakeholders were included in the program design and implementation.

Representatives from administration, cardiology, care management, health information management, information technology, nursing staff, organizational development, pharmacy, and quality improvement provided input on educational materials, protocols, and procedures developed for this program.

Before implementation, all educational materials and protocols were reviewed and approved by departmental leaders and the Institutional Review Committee (IRC). The study received exempt status from the IRC. A 90-day pilot program was implemented on the CCU from October 2012 to January 2013. Patients identified through risk assessment on admission as likely to have a primary diagnosis of HF at discharge were targeted to receive the intervention. Registered nurses, employed as quality auditors, used the electronic medical record (EMR) to identify these patients while performing regular daily chart reviews. Quality auditors notified the CCU pharmacist of these patients so he or she could prepare for each patient’s discharge. The pharmacist placed HF discharge instructions in each patient’s chart to prompt nurs-

Table 2. Follow-Up Phone Call Referral Criteriaa for Patients With Heart Failure Referral to primary care physician Weight gain 2-4 lb in 1-3 d Weight gain 3-5 lb in 1 wk Increased shortness of breath with activity Increased cough or wheezing Increased swelling in the feet, ankles, legs or abdomen Feeling more tired than usual Dizziness Increased number of pillows needed to sleep Need to sleep in chair Feeling sick Referral to emergency department Unrelieved shortness of breath Unrelieved chest pain Wheezing or chest tightness at rest Chest pain not relieved by nitroglycerin tablets (if ordered) Confusion or not able to think clearly Extreme fatigue a Agreed upon through input from cardiology, pharmacy and nursing representatives at SRHC.

HF-1: Discharge Instructions (%)

Oct-Dec 2011

Jan-Mar 2012

Apr-Jun 2012

Jul-Sep 2012

Oct-Dec 2012

Jan-Mar 2013

17/18 (94.4)

11/14 (78.6)

12/16 (75)

9/10 (90)

22/27 (81.5)a

18/18 (100)

CMS, Centers for Medicare & Medicaid Services; HF, heart failure a

All patients pat e ts receiving ece v g discharge d sc a ge education educat o from o a pharmacist p a ac st passed HF-1: Discharge sc a ge Instructions. st uct o s

ing staff to provide instruction before discharge if pharmacy staff was not available. Pharmacists assumed responsibility for providing and documenting all activities measured by HF-1 for HF patients discharged from the CCU during hours the service was provided. A checklist was developed to standardize educational materials provided, topics covered during education, documentation of activities, and to promote consistency among pharmacists. Pharmacists first performed a profile review for each HF patient to assess appropriateness of therapy, then reviewed the medication discharge instruction form if previously completed by nursing staff or transcribed the written form independently into the EMR. Pharmacists provided discharge instructions including all of the elements required in HF-1: activity level, diet, discharge medications, follow-up appointments, weight monitoring, and recommendations for worsening symptoms.

The pharmacist provided counseling for each medication prescribed, highlighting new medications and changes in therapy.

The pharmacist educated patients on symptom monitoring using a patient-specific action plan based on a color-coded “zone” principle developed for this program (Table 1, page 6). The action plan was designed to help patients easily identify appropriate actions according to symptom severity.

It includes spaces for patient-specific instructions intended to help patients manage their HF. For example, a physician may write for a patient to take an additional dose of furosemide if he or she gains 2 lb in 2 days and then, make sure that the patient understands the meaning of these instructions.

The pharmacist scheduled a followup phone call with each patient to occur between 48 and 72 hours post-discharge to assess adherence to and complications of therapy. Patients were instructed to have medications and discharge instructions available for the call. Telephone calls were scripted discussions covering medication use and symptom monitoring, which reinforced the education patients received in the hospital (Sidebar). Patient referral criteria were clearly defined and assessed as part of the telephone script (Table 2).

Pharmacists tried to contact each patient three times if the initial attempt was unsuccessful. Pharmacists stopped trying to contact patients after three unsuccessful attempts or after the first

attempt if incorrect contact information was provided. Patient encounters were documented in a standardized format in the permanent EMR. Quality auditors served as a resource for the CCU pharmacist, answering questions related to quality measures. Quality auditors also collected and reported data on HF patients. Pharmacist activities were tracked via surveillance and reporting software.

Results Pharmacists provided discharge instructions and reviewed discharge medication reconciliation forms for 15 of 27 patients (56%) with a primary diagnosis of HF during the first quarter of 2013 (Table 3). The first-quarter score is representative of the study period.

The HF-1 score for the first quarter was 81.5%. Every patient seen by a pharmacist passed the HF-1 element. Program

success continued through the second quarter of 2013.

We identified 37 patients during the study period with a likely primary diagnosis of HF discharged from the CCU. Twenty-one of these patients (57%) received discharge education. We did not provide instruction for all of the identified patients because pharmacists were not always available during discharge, and some patients did not meet requirements for HF-1 assessment (e.g., transfer to an outside facility, death before discharge, etc.).

We contacted 15 of the 21 patients (71%) for telephone follow-up, which averaged 20 minutes. The average number of attempts per call completed was 1.07. The average number of call attempts made per patient was 1.62. Ten patients (75%) were assessed to be adherent with their medications at follow-up. Eight

•

see TRANSITIONS, page 11

HF Patient Follow-up Phone Call

W

e feel that the follow-up phone call is important for a successful transitions-of-care program for patients with heart failure (HF). Therefore, we created a scripted form to make it easy for the pharmacist to assure that all aspects of follow-up are covered with each patient. The follow-up is scheduled 2 to 3 days after discharge, and patients are told to gather all prescription and over-the-counter medications, discharge medical records form and the daily weight log before the phone call.

The pharmacist starts completing the form at patient discharge, using this time to verify home medications against the medication reconciliation form and checking the patient’s contact information.

The follow-up call begins: “Hello Mr/Mrs_______. This is __________, a pharmacist from Salina Regional Health Center. I am calling today to check on how you are doing, talk to you about your medications, and answer any questions you may have. Do you have time to talk? Do you have your medications, medication list and weight log with you? Thank you.”

Then, the pharmacist goes through a list of questions to assess how the patient is feeling, whether he or she made appointments or was seen by the primary care physician and/or cardiologist, and whether any prescriptions were filled. A good portion of time is spent on assuring that patients understand the medication regimen and are adherent to ensure medication safety during the transition from hospital to home.1 The pharmacist goes through each medication and asks about name, dose, regimen, reason for the medication, side effects, and any questions or concerns.

The pharmacist also takes this opportunity to discuss any adherence issues, such as problems taking the medications or misunderstanding the instructions.

The pharmacist also reconciles any prescription medications with vitamins, supplements, and herbal products the patient might be using.

Another important monitoring issue for HF patients is weight gain, and the pharmacist spends time emphasizing the importance of weighing themselves every day, and what to do if the patient gains 2 lbs or more.

The follow-up call then transitions into a discussion about any other symptoms the patient may be experiencing, such as shortness of breath, dizziness or chest pain.

The pharmacist also asks about diet, the importance of drinking fluids and urination habits, and addresses any other questions or concerns the patient has. (For a complete copy of the script questionnaire visit www.pharmacypracticenews.com.)

Adapted from project RED Web Site. http://www.bu.edu/fammed/projectred/toolkit.html. 2013.

Accessed August 2013.

10 Operations & Management nagement

Pharmacy Practice News • August 2014

Ambulatory Care e Plan

OUTCOMES continued from page 1

domain and presented it at the ASHP conference, where th he components were discussed d and reworked.

Domains 4.1 and 4.4: Define Outcomes As the first recommendation states, ambulatory care pharmacists n need to collaborate with all stakeholders to “define the components of measurable m value that correlate pharmacissts’ unique contributions to patient outco omes.” The robust, inclusive approach is necessary given the myriad perspectivees on how to best define quality, Dr. Klliethermes pointed out. “For physicians, quality q may mean that a correct diagnosiss is made made, while for pharmacists it may mean that a recommended therapy has achieved the desired outcome,” she said. “Meanwhile, a health administrator may be looking at efficiency of clinical services, and a payor may look at how often generic medications are used.”

Although a multidisciplinary approach is exactly what is needed at the moment, Dr. Kliethermes said pharmacists and many other health care providers have been regularly excluded from the discussion on selection of outcomes measures.

“Right now, much of the discussion around this issue that goes on in health systems and hospitals happens at the C-suite level,” she said.

Dr. Kliethermes noted that under new and emerging models of care, such as patient-centered medical homes (PCMHs) and accountable care organizations (ACOs), some pharmacists are tracking quality measures. However, she distinguished between measures that look at processes and those that examine outcomes.

“I might keep track of each time I instruct a patient to do exercise, but it doesn’t mean that they are actually implementing my suggestion,” Dr. Kliethermes explained.

Even when a workable outcome measure is chosen, distilling the real effect of an intervention can be tricky, she noted.

This is because bits of data often lack context; data may talk, but their meaning can be lost in translation. “Two pharmacists might be targeting LDL [low-density lipoprotein] levels in two populations of diabetes patients, with one reducing the population’s average LDL to 90 mg/dL and the other lowering it to 105 mg/dL,” she said. On the surface, those results might seem to show a difference in the quality of service; however, the raw data do not reveal that the first group of patients started at an average LDL of 105 mg/dL, whereas the second population started at 180 mg/dL before decreasing to 105 mg/dL.

• Objective • Predictions • Plan to carry out cycle (who, what, where, when) • Plan for data collection

she said. “M Moving down this path won n’t be easy.”

Act Ernesst R. Anderson Jr., • What changes MS, RP Ph, a consultant in are to be made? ton, Mass., who Brock • Next cycle? was not directly involved in developing the ASHP Study Do re ecommendations, • Analyze data • Carry out the plan said d this recommen• Compare results to predictions • Document datio on and others in observations • Summarize what the domain are comprewas learned • Record data hensive and appropriate.

Mr. Andeerson added that some of the clinical outcomes that ambulatoryy care pharmacists help improve need to be tracked over the long term. “C Control of LDL and HbA1c [glycosylated hemoglobin] and anticoagulant monitorring—these are all important outcomes that can demonFigure. The Plan, Do, Study, strate that we are helping patients reach Actt approach to quality their treatment goals,” he said. “But there improvement. are also outcomes that I believe we contribute to but that are measured over “In this case, the more significant years. For example, improved cardiovasimprovement in patient health out- cular health theoretically leads to longer, comes is probably occurring in the pop- healthier lives, but it takes years to show ulation with higher initial average LDL, a longitudinal effect.” since they had the greatest reduction in Domain 4.3: Health IT LDL levels,” Dr. Kliethermes said.

Whether outcomes are measured over Domain 4.2: Data, Data, Data! the long or short term, ambulatory care This recommendation calls for ambu- pharmacists need strong health informalatory care pharmacists to partner with tion technology (HIT) in place to “enable patients and members of inter-profes- timely collection, monitoring and analysional health care teams “to demonstrate sis of data” and improve patient care, this measurable and meaningful impact on recommendation states. individual patient and population out“There’s no way we can track and comes.” In Dr. Kliethermes’ view, “there’s measure outcomes without HIT,” Dr. an ongoing discussion about whether we Kliethermes said. “We need decent need to call out the pharmacist’s impact HIT architecture to make outcomes on outcomes in the first place, or to sim- tracking a regular and streamlined part ply make sure the team is producing the of our workflow.” best possible outcomes. Nevertheless, She said pharmacists in the ambulamany ambulatory care pharmacists will tory setting need access to patients’ be asked to demonstrate their specific electronic health records, whether contributions to quality of care to justify they are derived from a claims datatheir role.” Teasing out the effectiveness base, are inpatient or outpatient of each provider is “incredibly complex,” records, or come from a health system

Looking for Outcomes Measures?

T

he National Quality Measures Clearinghouse (NQMC) database includes more than 8,000 evidence-based quality measures, and allows users to search the site according to areas of interest (www.quality measures.ahrq.gov).

The Institute of Medicine’s report, “Core Measurement Needs for Better Care, Better Health, and Lower Cost: Counting What Counts,” provides a framework for building core measure sets that align with the institute’s “triple aim”: better care for individuals, better health for populations and lower per-capita care costs (http://www.nap.edu/catalog.php?record_id=18333).

The Pharmacy Quality Alliance (PQA) website contains a library of measures and concepts of measuring (www.pqalliance.org).

The National Committee for Quality Assurance (NCQA) created the Healthcare Effectiveness Data and Information Set (HEDIS), which is a set of measures that employers use to evaluate their employees’ health plans. Ninety percent of health plans, and Medicare and Medicaid, use HEDIS measures to assess their own performance, as well as dimensions of care and service. Providers who contract with these health plans are also responsible for meeting the HEDIS measures (www.ncqa.org).

Source: Kliethermes MA. Outcomes Evaluation: Striving for Excellence in Ambulatory Care Pharmacy Practice (http://www.ashpmedia.org/amcare14/Outcome-Evaluation.pdf)

unaffiliated with the pharmacy.

As providers and payors place increasing emphasis on continuity of care, using HIT to connect disparate provider groups makes sense, Mr. Anderson noted. “People have been operating in silos, with hospitals and primary care physicians communicating very little.”

He added that he is heartened by the emergence of newer HIT systems, such as EPIC, that combine inpatient and outpatient records, as well as providers like eClinical Works that make patient data available through secure Internet portals.

Although these newer systems are a good start, Dr. Kliethermes said ambulatory care pharmacists need to convey their needs to IT providers. “Currently, claims databases are the only readily available source from which we can draw data for medication- and pharmacist-related quality measures,” she said.

“Claims data are generated primarily for payment and not for clinical data, which creates problems with data integrity. For example, in measuring adherence, data are entered in a way that assures payment, and they may not consistently and accurately reflect adherence.”

Domain 4.5: QI Principles Aside from providing evidence that pharmacists working in ambulatory care settings need so they can demonstrate their value, outcomes data also should be used to improve care through the application of “quality improvement principles,” the recommendations state.

A quality improvement approach that is practical for small practice settings is the Plan, Do, Study, Act (PDSA) cycle, Dr. Kliethermes said (Figure). “Using PDSA, one can make changes and evaluate success in a short period of time,” she noted.

Using the PDSA method, pharmacists begin by deciding on the goals they want to reach and what strategies they will be testing to reach that goal (Plan). The next step is to implement the strategies (Do) and follow this with an analysis (Study) of the effect of those strategies. The last step is to draw lessons from this PDSA cycle, and use these to develop and refine further strategies (Act), implemented in subsequent PDSA cycles.

“The key to a successful quality improvement program is to incorporate it into the daily workflow,” Dr. Kliethermes stressed.

Domain 4.6: Participate!

Working at the community, state and national levels, pharmacists providing ambulatory care services need to “par-

•

see OUTCOMES, page 11

Operations & Management 11

Pharmacy Practice News • August 2014

Ambulatory Care ticipate in health care policy development related to improving individual and population health outcomes,” this section of the domain recommends.

“Medications are such a critical component of health care,” Dr. Kliethermes said. “Since we play such a large role in health care, we need to be involved in the process of determining which quality outcomes are measured.”

‘Since [pharmacists] play such a large role in health care, we need to be involved in the process of determining which quality outcomes are measured.’

the full effect of pharmacy services on patient outcomes, Mr. Anderson said the data on medication reconciliation provide only a partial picture and, therefore, undervalue ambulatory pharmacist care.

“My sense is that medication reconciliation also improves overall health over the long term and saves money,” he said. “Unfortunately, from the perspective of payors and administrators, if it’s not being measured, it isn’t happening.”

—Mary Ann Kliethermes, PharmD

Domain 4.7: More Research The final recommendation of this domain makes a further call for pharmacists in the ambulatory care setting to document their value as care providers.

Dr. Kliethermes said that although the profession has made great strides in this area, additional research documenting

TRANSITIONS continued from page 8

patients (53%) had been taking daily weights at follow-up. Pharmacists made 15 medication-related interventions and 8 interventions regarding symptom monitoring at follow-up. Pharmacists referred 4 patients (27%) to their primary care providers, and contacted 2 physicians directly. No patient was instructed to call 911 or to come to the ED. SRHC’s 30-day readmission rate for patients with a primary diagnosis of HF following the study period was zero.

Discussion The HF pilot program identified challenges and strategies for implementing successful transitions-of-care processes.

We found that a collaborative, multidisciplinary approach is effective for achieving goals while improving efficiency by reducing duplicative efforts. We found input from administration, cardiology, care management, health information management, information technology, nursing staff, organizational development, pharmacy, and quality improvement to be crucial in program design and success. As a result of our efforts, every patient located on the CCU discharged with a primary diagnosis of HF was identified by quality auditors and communicated to the CCU pharmacist.

All patients with a primary diagnosis of HF receiving discharge instructions from a pharmacist during the study period passed the HF-1 quality measure.

The data confirm key principles for the design of a successful transitionsof-care program. A transitions-of-care program that identifies and targets high-risk patients at admission by probable primary diagnosis at discharge will identify more patients for the intervention than actually receive that primary diagnosis. Delays inherent in charting and coding result in a degree of uncer-

—David Wild the effectiveness of ambulatory pharmacy care is needed. “There are some people who believe there’s enough research to justify including a pharmacist on the patient care team,” she said. “Yet, we’re

still having trouble being widely included on these teams because of our relatively high cost as mid-level providers with no direct revenue billing sources.”

Confirming the difficulty of capturing

Mr. Anderson serves as a consultant for MCS Carelink, a company that provides solutions for pharmacy care across the continuum.

Dr. Kliethermes reported co-owning Clinical Pharmacy Service Inc., which develops software for ambulatory care pharmacies.

tainty regarding the primary diagnosis at discharge. This should be considered when estimating the resources such a program would require. The influence on workload would depend on how each team member’s responsibilities are allocated. Each team member should have clearly defined responsibilities in a transitions-of-care program to improve the potential for success. Assigned responsibilities should reflect each member’s area of expertise and facilitate the discharge process overall. Communicating these responsibilities encourages teamwork as members understand each person’s contribution. Standardizing educational materials and methods for documentation related to discharge further improves the chances for success.

We also found that scheduling followup telephone calls with an appointed date and time is an effective practice for contacting patients to review discharge instructions because most patients were prepared for the telephone call. We believe that patients were also more likely to follow discharge instructions versus those receiving regular care because they knew a pharmacist would be inquiring about their progress. Early follow-up is key to reinforcing discharge instructions, which can result in meaningful interventions. Medication-related interventions included discussing the importance of adherence, stopping discontinued medications, and assuring medication dose. Symptom monitoring interventions included instruction on taking daily weights, and monitoring for edema and shortness of breath.

One-fourth of the patients we contacted met criteria for referral to their primary care provider. Importantly, none of the patients met criteria for referral to the ED. This represents a potential readmission avoidance of 4 patients for the 90-day study period. This alone justifies the transitions-of-care program for high-risk patients. Contacting

high-risk patients during the immediate post-discharge period, 48 to 72 hours later, provides an opportunity to make positive interventions regarding appropriate medication use and symptom monitoring, preventing deterioration in a patient’s status that might otherwise lead to an HF exacerbation.

This study was limited by its relatively small sample size and duration of the pilot program. We were unable to calculate the statistical significance of our program due to these limiting factors. However, implementation of the transitions-of-care program has affected the scope of practice for pharmacists at SRHC. We made a positive measurable difference on the quality of patient care.

Since the implementation of the pilot program, pharmacists have taken responsibility for the HF discharge instruction score hospital-wide with continued success, and the CCU pharmacist position has become a permanent one.

We are looking to expand this program to include other high-risk conditions and improve additional quality measures.

For example, pharmacists at SRHC have since realized their potential for assisting with other HF quality measures through this initiative. We have improved communication and collaboration among team members and have been asked to present our findings to others within our organization. The effect of this project has even been felt outside of SRHC, as we have shared educational materials we developed with community nursing homes and hospitals within our network.

measures, providing financial incentive for pharmacist involvement in reducing 30-day hospital-use rates. The next step is to perform a cost-savings analysis and to expand the program to include patients with other high-risk conditions.

Conclusion We describe an effective way to develop an efficient collaborative hospital practice model in transitions of care.

Such programs can improve quality of care, reimbursement, and collaboration among health care providers. Working together, pharmacists and quality auditors can improve quality indicator

References 1. Budnitz DS, Lovegrove MC, Shehab N, et al.

Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med. 2011;365(21):2002-2012.

2. Coleman EA, Smith JD, Raha D, et al. Posthospital medication discrepancies: prevalence and contributing factors. Arch Intern Med. 2005;165(16):1842-1847.

3. Masoudi FA, Baillie CA, Wang Y, et al. The complexity and cost of drug regimens of older patients hospitalized with heart failure in the United States, 1998-2001. Arch Intern Med. 2005;165(18):2069-2076.

4. Forster AJ, Clark HD, Menard A, et al. Adverse events among medical patients after discharge from hospital. CMAJ. 2004;170(3):345-349.

5. Forster AJ, Murff HJ, Peterson JF, et al. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003;138(3):161-167.

6. Al-Rashed SA, Wright DJ, Roebuck N, et al.

The value of inpatient pharmaceutical counseling to elderly patients prior to discharge. Br J Clin Pharmacol. 2002;54(6):657-664.

7.

Hope CJ, Wu J, Tu W, et al. Association of medication adherence, knowledge, and skills with emergency department visits by adults 50 years or older with congestive heart failure. Am J Health Syst Pharm. 2004;61(19):2043-2049.

8. Jack BW, Chetty VK, Anthony D, et al. A reengineered hospital discharge program to decrease rehospitalization: a randomized trial.

Ann Intern Med. 2009;150(3):178-187.

9. Dudas V, Bookwalter T, Kerr KM, et al.

The impact of follow-up telephone calls to patients after hospitalization. Am J Med. 2001;111(9B):26S-30S. 10. Schnipper JL, Kirwin JL, Cotugno MC, et al.

Role of pharmacist counseling in preventing adverse drug events after hospitalization. Arch Intern Med. 2006;166(5):565-571.

11. Eggink RN, Lenderink AW, Widdershoven JWMG et al. The effect of a clinical pharmacist discharge service on medication discrepancies in patients with heart failure. Pharm World Sci. 2010;32(6):759-766.

12 Operations & Management

Pharmacy Practice News â&#x20AC;˘ August 2014

Ambulatory Care Part 2 of a two-part series

Pharmacists and Medical Homes: A Potent Mix?

A

city-based health system is in the midst of an aggressive effort to bolster its care of patients with complex health needs, many of whom frequently use the emergency department (ED), by expanding post-discharge access to patient-centered medical homes (PCMHs). Pharmacists are key members of these interdisciplinary care teams.

Denver Health, comprising Denver Health Medical Center, a level 1 trauma center and teaching hospital affiliated with the University of Colorado, and eight primary care clinics, has begun a transformation of its primary care practices through what it terms its 21st-century care model. The plan, funded by a three-year, $19.8 million

grant from the Centers for Medicare & Medicaid Servicesâ&#x20AC;&#x2122; Center for Medicare & Medicaid Innovation, aims to increase access to care for an additional 15,000 patients; improve population health and patient satisfaction by 5%; decrease overall health care costs by 2.5%; and cut Medicare and Medicaid spending by $12.8 million.

This activityâ&#x20AC;&#x2122;s distinguished faculty

Before this program, more than half of hospital admissions came through the ED, according to Paul Melinkovich, MD, Denver Healthâ&#x20AC;&#x2122;s director of ambulatory care services. Additionally, the 3% of the systemâ&#x20AC;&#x2122;s â&#x20AC;&#x153;super utilizersâ&#x20AC;? drove 30% of the facility charges, said Tracy Johnson, PhD, a special assistant to the CEO for health reform, and 43% of these super utilizers did not have access to established medical homes.

Reviewing records, administrators grouped patients into four tiers based on health care utilization. Patients who are generally healthy are given access to health information technology (HIT) to engage them in care. The next tier, such as patients with a single chronic disease, has HIT support and outreach from a patient navigator to keep them on track.

For patients with more complex health needs, the system established multidisciplinary health outreach teams and created three high-risk outpatient clinics: one for children with special health care needs, one for adults with a history of frequent hospitalizations and one outsourced to the Mental Health Center of Denver for those with a history of frequent hospitalizations and mental illness.

The program planners also hired 23 patient navigators, three clinical pharmacists, three pediatric nurse care coordinators and five behavioral health consultants to staff clinics and teams. The pharmacists focus on chronic disease management, offloading these patient visits from providers and increasing access for other patients, according to Tara Vlasimsky, PharmD, the associate director of pharmacy for Denver Health Medical Center.

They also work with patient navigators in transitioning patients from the hospital to their homes; making sure patients have their medications and understand how to take them; and ensuring that a followup visit is scheduled within seven to 14 days of discharge. During these follow-up visits, pharmacists see high-risk patients alone or with physicians for medication reconciliation and education.

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Current Symptoms Â&#x2021; Dyspnea Vital Signs Â&#x2021; Height: 175 cm Â&#x2021; Weight: 85 kg 6LJQLÂżFDQW 0HGLFDO +LVWRU\ Â&#x2021; Hypertension Â&#x2021; Congestive heart failure Â&#x2021; Obstructive sleep apnea &XUUHQW 0HGLFDWLRQV Â&#x2021; Metoprolol 100 mg PO Â&#x2021; Ramipril 2.5 mg PO Laboratory Results Â&#x2021; Apnea hypopnea index: 26/h Â&#x2021; Left ventricular ejection fraction: 30%-35% Anesthesia is induced with sufentanil, propofol, and 0.6 mg/ kg rocuronium based on total body weight and maintained ZLWK GHVĂ&#x20AC;XUDQH LQ DLU R[\JHQ DQG VXIHQWDQLO 6XUJLFDO FRQGLWLRQV DUH GLIÂżFXOW ZLWK D ODFN RI DEGRPLQDO ZDOO PXVFOH relaxation and poor paralysis. An extra dose of rocuronium is administered for deeper neuromuscular block (NMB), and fewer than 2 train-of-four (TOF) responses are noted.

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Limited health literacy is part of the challenge clinicians face in managing these patients, Dr. Vlasimsky noted.

Many of them come from other countries, do not speak English and may not receive discharge instructions in their native tongue. â&#x20AC;&#x153;Itâ&#x20AC;&#x2122;s an overwhelming time for patients,â&#x20AC;? she said. â&#x20AC;&#x153;Theyâ&#x20AC;&#x2122;re vulnerable and may not remember everything when they get home.â&#x20AC;?

Adrian Boka, PharmD, joined the team in October 2012 at the systemâ&#x20AC;&#x2122;s Wellington Webb Center for Primary Care,

Operations & Management 13

Pharmacy Practice News • August 2014

Ambulatory Care also in Denver. Dr. Boka participates in a daily “discharge huddle,” reviewing the hospital’s discharge list to identify patients on high-risk medications or with conditions like heart failure at risk for hospital readmission. She also helps the navigators transition patients to home and calls patients, many of whom have low health literacy and a fifthgrade or lower education, to review their medications and instructions.

“A lot of the work is patient education,” said Dr. Boka, who estimates she works with eight to 10 patients per day, “trying to educate them (either face-toface or by phone) on why they’re taking these medications and about their disease state.”

Dr. Boka also conducts some followup visits with physicians. “If I can do the education, the doctor can just see what’s going on acutely, resulting in provider time saved,” she said, potentially freeing up physicians to see additional patients. All pharmacy visits and phone calls are recorded through intervention-tracking software.

Although formal data have not yet been published, Dr. Boka said the interventions are working. One patient recently showed up at the clinic asking for her. He had a domestic dispute with a family member, who threw out his inhalers and drained his oxygen tank.

Dr. Boka was able to get the patient’s inhalers refilled early and work with a medical equipment company to obtain a new oxygen tank. The patient confessed that if not for Dr. Boka, he would have gone to the ED for help.

Patients and providers believe that the care teams help prevent rehospitalizations and ED visits and make transitions more seamless, Dr. Vlasimsky said. But again, hard data on such outcomes have yet to be collected.

Other PCMH Efforts Denver is not the only health system where pharmacist interventions improve PCMHs. Since 2009, the University of Michigan has used pharmacists as an extension of physicians in managing patients’ chronic conditions. In 14 primary care clinics, pharmacists provide services for patients taking multiple medications or who have diabetes, hypertension, hyperlipidemia and other chronic conditions. The teams develop medication care plans, do medication reconciliation, order lab tests and follow up with patients after visits. They also advise physicians on medication regimens and screen chronic disease registries to help identify patients in need of medication management.

The program “has been very successful in recognizing pharmacists as key members of the care team,” said Hae Mi Choe, PharmD, its director of innovative ambulatory pharmacy practices. As a result,

Adrian Boka, PharmD (left) and Josh Gannon, RPh, discuss patient counseling techniques they use in Denver Health’s medical home model of care.

other health systems in the state have adopted the model and the program has become part of a larger accountable care organization, with the goal of partnering

with 11 other physician groups.

Several studies indicate that pharmacist intervention helps decrease health care utilization and improve

outcomes in transitions of care, said Dr. Choe, but “it’s hard to sort out what portion of that positive outcome came from pharmacist i n t e r v e n t i o n .”

Still, “early touch with patients on discharge is important.”

—Karen Blum

Part 1: “Medical Homes Get Spruce-ups.”

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Reference: Gorfine SR, et al. Dis Colon Rectum. Dec 2011;54(12):1552-1559.

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For more information, visit www.EXPAREL.com ©2013 Pacira Pharmaceuticals, Inc., Parsippany, NJ 07054

EXP-AP-0039-201302

14 Operations & Management

Pharmacy Practice News • August 2014

Leadership in Action Executing trust:

The Business of Highly Performing Teams

F

or several articles now, I’ve been looking at the act of thinking and how it affects our creativity, productivity and leadership. I’ve also explored strategies for fostering trust, which plays a key role in the building of highly performing teams. In this article, we are going to conclude our discussions about trust by looking at its execution

in a way that enables teams to perform at their peak.

Be Patient As Henry Cloud stated in “Boundaries for Leaders” (HarperCollins, 2013), “To execute trust means to produce in accordance with a plan or design.” Sounds easy, right? Well, not so fast. Creating

trust takes time and requires a consistent effort at execution, often over several months. It is a learning and growing process. You, as the leader, are in charge of guiding this process.

To help you get started, here are eight suggested elements that you can work through with your team to begin to create trust.

EXP-AP-0020-201301

“Leadership in Action” is authored by Ernest R. Anderson Jr., MS, RPh, of Brockton, Mass.

Mr. Anderson welcomes your input on leadership issues, at ernestanderson1130 @gmail.com

Ernest R. Anderson Jr., MS, RPh

1. Define trust. We fully examined this element in our last segment, but briefly, trust includes connecting and motivating your team; possessing the skills and abilities as a team to “get it done”; performing with character; and demonstrating a track record. Explore each element with your team, and discuss how these elements will produce results for individuals and for the department as a whole. If they are not on the same page, talk about the sources of disagreement until there is understanding and buy-in. If you need outside help to facilitate this, it may be worth the expense.

2. Define shared objectives. On what goals can team members work together, for the good of the whole? Making these determinations may require examining how team members can cross over to help colleagues outside of their primary responsibilities. For example, there may be instances when you need all hands on deck to accomplish a goal, get a program implemented, institute a new computer software program, etc.

3. Define operating values and behaviors. What is the team’s collective purpose, its overall vision and mission?

It may be stated as broadly as “providing therapeutically appropriate medication therapy in a cost-effective manner.”

What does that mean to each person in his or her area of responsibilities within the pharmacy? Perhaps a shared value can be to understand the new paradigm of health care under the Affordable Care Act, and how, based on that shared value, we should adapt and change our practice.

What behaviors will be required in this new paradigm? Talk it through.

4. Use case studies. Many of us work at hospitals that are implementing new technologies and programs. What aspects went well and not so well? Ask the “why” questions and collectively learn from the answers. Look to others who have implemented similar programs and learn from their experiences. Take field trips and speak with colleagues at other institutions.

5. Make covenants for behaviors. A covenant is a promise or an agreement.

Such aggreements often are based on norms of how we relate to one another and perform our tasks. You may want to set specific norms within your group, such as listening, showing respect, building strong relationships with your customers (including patients, physicians and nurses), agreeing on priorities, aligning goals and determining the methods of implementation.

Operations & Management 15

Pharmacy Practice News • August 2014

Leadership in Action Once you implement some of these norms and strategies to create a hightrust environment, you should begin to see many of your team members achieve new levels of success. And that’s the ultimate goal, isn’t it? In my experience, the greatest satisfaction for a leader comes when we see others succeed in their professional and personal lives. What an accomplishment to facilitate such growth!

Next month, we will conclude this series on boundaries by looking at boundaries for you as a leader.

■

‘The greatest satisfaction for a leader comes when we see others succeed in their professional and personal lives.’

6. Develop accountability systems.

In modern health care systems, we are driven and evaluated by metrics. What are those metrics for the various operations within your department and for individuals? How will people be measured and held accountable?

A caution here is to develop metrics that encourage cooperation across segments of the department, instead of those that promote malicious competition. The idea is to foster a positive atmosphere, with norms that allow people to ask for help when they are not accomplishing their goals. Also, don’t forget to enlist the help of your team in developing these norms, because doing so enables buy-in.

7. Establish an observing structure.

Another powerful norm you can establish in your team is to observe yourselves and your interactions as a unit, evaluating and seeking opportunities to improve.

Once you begin a new process, ask, “How is it working?” After each meeting, assess which interactions worked well and not so well. What are some examples of living out the values? Ask how you can do things differently and better. What new training, mentoring or education do your team members need?

8. Give positive feedback. Finally, keep in mind that positive feedback— “the breakfast of champions,” according to management guru Ken Blanchard—is a critical tool in establishing trust. After all, we all want to feel good about what we accomplish.

Coming soon

Keeping Trust on Front Burner Despite all of these efforts, some people may have difficulty grasping the concept of trust; admittedly, it can seem a little nebulous and soft. But you know when it is present and when it is not.

This can apply to your management team, to areas within your pharmacy or even to you as the pharmacy leader.

When that happens, I find it helpful to remember why it is so important to establish trust: It is the oil that greases the wheels to get things accomplished.

Furthermore, trust increases your efficiency, maximizes your creativity and frees people to be honest with one another. When trust is high, even feedback is welcomed, because people want to learn and grow. This breeds success, collaboration and cooperation, and actually can be exciting. The atmosphere can be one of great challenge but also one of high satisfaction.

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16 Operations & Management

Pharmacy Practice News • August 2014

Drug Diversion

OXYCODONE continued from page 1

He also faces one count of grand larceny and 247 counts of criminal possession of a controlled substance.

D’Alessandro was fired from the hospital at the end of April, and also was let go from Staten Island University Hospital, where he worked weekends as a per diem pharmacist.

“For a pharmacist working alone, this is one of the larger cases of drug diversion,” said Carmen Catizone, RPh, executive director of the National Association of Boards of Pharmacy.

Usually more than one person would have been responsible for theft of this magnitude, he said.

Shortly after Beth Israel’s parent company, Continuum Health Partners, merged with Mount Sinai Medical Center to form the Mount Sinai Health System last fall, the new administration received an anonymous letter documenting D’Alessandro’s alleged theft, according to Ms. Brennan’s statement.

The administration then launched an internal investigation and audit before referring the case to the Office of the Special Narcotics Prosecutor.

The investigations found that D’Alessandro used his position and knowledge of the hospital’s systems to divert 193,376 oxycodone pills on at least 218 dates between January 2009 and April 2014, the statement said. He accessed the hospital medication vault and removed various quantities of oxycodone, initially 100 to 500 pills at a time. On April 2, the day after hospital administrators questioned him, he removed 1,500 pills from the vault.

D’Alessandro made false entries to the electronics narcotics inventory system indicating the medication was being sent to the hospital’s research pharmacy, known as the Investigational Drug Service (IDS). But the pills were never shipped to the service, which also fell under D’Alessandro’s control.

Additionally, he filled at least seven fraudulent prescriptions written in his wife’s name at a hospital pharmacy.

Beth Israel personnel declined to be interviewed for this story. “In light of the ongoing investigation, we are going to decline further comment at this time,” said hospital spokesman Sid Dinsay.

But pharmacists knowledgeable about preventing drug diversion told Pharmacy Practice News that the prosecutor’s statement revealed an apparent breakdown in policies or procedures that should have prevented D’Alessandro from taking drugs from the vault.

“That director of pharmacy should never have been processing controlled substances; that should have been a red flag,” said Jim Jorgenson, RPh, CEO of Visante Inc., a health care consulting

organization. “Directors in a hospital the size of Beth Israel shouldn’t be doing anything at all with controlled substances other than checking processes to provide oversight.”

Mr. Catizone said he would be interested to know how D’Alessandro explained so much missing product during regularly scheduled inventories. The fact that such a deception can occur underscores that hospitals may be more prone to diversion than is often assumed, he noted. “People may think that within hospital pharmacies, diversion [occurs infrequently] because there are controls in place,” he said. “But if the pharmacists don’t have accountability, it can be just as prevalent as in community pharmacy locations.”

Robert Adamson, PharmD, vice president of clinical pharmacy services at Barnabas Health, a large health care network in New Jersey, said if one of his hospitals had an investigational drug protocol, the drug used for that protocol would be stored locally with the IDS—not in the main hospital vault.

“You don’t want to commingle inventory,” he said.

He added, “I cannot fill a family member’s prescription. I can bring it to the pharmacy but I can’t process it, and I don’t want to.”

Emory Martin, PharmD, vice president of pharmacy services at Baylor Scott & White Health System in Temple, Texas, said he found it interesting that the anonymous tip came after the parent company merger. The exposure to a higher level of checks and balances that occurred as a result of the merger, he noted, may

well have been the tipping point in uncovering the oxycodone diversion.

“In a stand-alone hospital, the pharmacist-incharge [PIC] is generally the last protection against diversions,” Dr. Martin explained.

Although such solo practice sites have an internal audit arm and an internal compliance area, “those [safeguards] are generally not sophisticated enough to catch diversion by the PIC.” Indeed, the onlyy employees who likely would have noticed the thefts would be those who signed in to the vault immediately after the thefts occurred, he added.

However the specifics of the case pan out, Dr. Martin noted, “this is a shocking accusation against a pharmacy director.”

Could the D’Alessandro thefts been foreseen and prevented? In Dr. Adamson’s view, “there are a lot of red flags that are obvious now but are not that obvious when you’re going through it.”

Internal, External Reviews The experts interviewed by Pharmacy Practice News offered several tips to prevent diversion. According to Mr. Jorgenson, one good place to begin is to ensure that your organization is frequently taking a step back to review not only how controlled substances are handled but also how it approaches its entire inventory process. No matter how good systems are, some people will try to get

After $2M Fine, a Plan for Prevention

S

o what happens after drug diversion is found at a hospital? In the case of St. Vincent Indianapolis Hospital, “they re-did pretty much every controlled substance policy and procedure,” said Anthony Antonopoulos, RPh, MBA, the hospital’s executive director of regional pharmacy services.

In 2007, hospital pharmacy technician Dianne Hauss and her son Mark were sentenced to prison for conspiracy to distribute a controlled substance. A DEA investigation found that Mrs. Hauss had been stealing at least six bottles of hydrocodone weekly and giving them to her son to sell. An audit revealed a shortage of 623,861 hydrocodone/apap tablets, in addition to numerous record-keeping and security violations, prompting the DEA to fine the hospital $2 million.

Mr. Antonopoulos, who was not employed by St. Vincent at that time, said although those thefts occurred from an outpatient pharmacy, revised policies affected the inpatient pharmacies as well. The hospital had a consent decree with the DEA and committed to putting a series of steps in place to revamp pharmacy operations, including maintaining better records; plans were shared with the state board of pharmacy and the DEA and subject to periodic check-ins.

Before drug diversion occurred, he said, “they didn’t have different employees buying and receiving product and stocking shelves. That definitely changed.”

Additionally, he noted, not only CII controlled substances but all Schedule C-III, C-IV and C-V drugs were placed on perpetual inventory, and access to the CII safe room was further restricted.

The thefts also had a huge impact on morale, Mr. Antonopoulos stressed, because Mrs. Hauss had been employed by the hospital for more than 25 years. “Pharmacy directors really need to support employees during these challenging times, let them know it will be OK and work together to move forward,” he said.

Mr. Antonopoulos added that with the steps taken, he no longer worries about drug diversion. “It’s something that’s now in our rear-view mirror.”

—K.B.

around them, so regular reviews are essential. Sometimes an external review also is helpful. “You become so comfortable with your own systems, just having someone else take a look uncovers opportunities for other things to do,” he said.

Mr. Catizone said background checks— both criminal and financial—of all pharmacy employees are m essential. Regular inventories also are critical and ideally they should be kept in real time.

For Dr. Martin, workflow considerations need to be part of the selfassessment plan. “You need a division of duties,” he said. For example, the employee ordering medication should not be the one receiving it. Many times in cases of diversion, he noted, an employee will order two shipments of drugs at the same time and divert the second shipment. Pharmacies also need to ensure that stock transferred to another area of the hospital is actually received in that area. Finally, the head pharmacist should stay out of the vault except to perform audits, Dr. Martin stressed, adding that in a smaller or one-pharmacist hospital, the head pharmacist should invite a pharmacy employee or compliance officer to participate in an audit.

Automation Can Succeed Where Humans Fail Barnabas Health uses a Pyxis CII safe to track and monitor controlled substances, and pharmacy staff who use it must register their fingerprints, Dr. Adamson said. It’s easier than remembering codes, and employees can’t punch in for someone else. He recommended that hospital pharmacies also conduct regular surveillance of inventory to protect against diversion, and that reviews be performed by at least two employees.

If you find that diversion is going on, “the best thing you can possibly do is quantify the diversion as best you can and divulge the information to the Drug Enforcement Agency [DEA],” Mr. Jorgenson said. “If you can be as proactive as possible, it can help mitigate potential sanctions and fines to the hospital imposed by the DEA.” —Karen Blum The sources reported no relevant financial conflicts of interest.

Web Exclusive: More Tips for Preventing Diversion, from James A. Jorgenson, RPh, MS, FASHP. www.pharmacypracticenews.com

18 Policy

Pharmacy Practice News • August 2014

Reimbursement Matters In their shoes:

Reaching Out to Reimbursement Team Pays Off T

he whirlwind of change in health care reimbursement brought on by the Affordable Care Act has spawned several hybrid delivery models that leave many stakeholders bewildered.

One thing, however, is clear: Relying on old technology, clinging to the past, remaining siloed in your own department and fighting this inevitable change is just not acceptable in today’s fluid hospital pharmacy environment.

A far better approach would be to welcome and adapt to this change. That process will go a lot smoother if you understand what your fellow health care workers are doing, and they learn more about what happens in the pharmacy.

The plan? Put yourself in their shoes for a day and learn how you are helping, inadvertently creating issues or stonewalling the overall mission.

You can begin this empathetic endeavor by focusing on top-tier members of the reimbursement team: Revenue cycle and finance department. High up on the list must be the

recognition that patients face increased exposure to health care costs regardless of the disease state(s) for which they are seeking care. This translates into an urgent need for meaningful and transparent pricing information.

This is the essence of what the revenue cycle team does to maintain the Charge Description Master file in sync with the Pharmacy Drug Master file, along with a defined pricing strategy that is explainable, defendable and accurate.

Patients need information to understand the total price of their care and what is included in that price.

Patient navigators. These staffers play an increasingly important role in guiding the patient through the complicated steps of therapy for complex disease states. Navigators could be social workers or nurses, and there are pros and cons that each of those caregivers bring to the

CMS Changes That Affect You!

T

he July 2014 updates to the average sales price (ASP) tables have been released and can be found at http://go.cms.gov/ VQmANZ. As always, the ASP tables are available in three formats: July 2014 ASP Pricing File 06/17/14; Jul 2014 NOC Pricing File 06/10/14; and July 2014 ASP NDC-HCPCS Crosswalk 06/17/14. Remember to deduct 2% sequestration from the listed rates.

The third format, which matches the Healthcare Common Procedure Coding System (HCPCS) number to the national coverage determination number, is a perfect tool for ensuring accuracy in your pharmacy drug master and compliance with your waste-billing program because it identifies and provides the maximum number of billing units that can be billed for a specific vial.

Also note the increasing number of products that now are being reimbursed at average manufacturer price instead of ASP and the references to the new vaccine pricing for the upcoming influenza season.

role of navigator. They may have different backgrounds depending on their clinic or treatment area. An oncology navigator may play a different role than a navigator in neurology, rheumatology or gastroenterology.

Regardless of area or background, patient navigation is now a standard of care and covers implementing the treatment plan and ensuring the patient understands the financial implications of that treatment. Educating patients and families is a key part of this process; including the medication component is vital, especially when it involves complex, expensive specialty drug therapies. Navigation also entails determining responsibility or ensuring that prior authorizations and local and national coverage determinations are met and followed.

Nursing, revenue cycle team coders.

The nursing component of the patient care team holds responsibility for ensuring that the treatment actually occurs in the sequence decided on by the team and that the provision of such care is accurately documented.

Also, ask yourself a few key questions about factors that can affect reimbursement. For example, what tools have you given nursing through computerized prescriber order entry and electronic medication administration records to ensure that this is done in a manner that fosters payment? Did you structure the wording in these electronic

“Reimbursement Matters” is a tool for maintaining your health system’s fiscal health.

Please email the author at bkirschen@aol.com with suggestions on reimbursement issues that you would like to see covered.

Bonnie Kirschenbaum, MS, FASHP

documents to facilitate this process, or have you left it vague and confusing and to the nurses’ discretion? Are you relying on the coder in the revenue cycle area to translate documentation correctly or did you provide the tools that would streamline these steps? Has your facility extended these electronic tools to the outpatient areas? If not, what could you be doing to help facilitate this IT expansion?

The IT team. Big data and analytics describe the art and science of making decisions based on a collection of information from a variety of sources.

Decision making no longer depends on “in my professional experience,” but should be based on professional interpretation of evidence-based data collection. Sounds exciting, right? But what if the data are incomplete or inaccurate because of how they are collected, manipulated or transmitted?

This is a learning experience for everyone. Inviting all the departments to spend a day in the various segments of pharmacy that are influenced by their behavior is equally important. Using this information to change what does not work and be more respectful of how you affect others comes next!

■

CMS May Boost Outpatient Hospital Payments in 2015

T

he Centers for Medicare & Medicaid Services (CMS) released a proposal that would raise its outpatient payments to hospitals by 2.1% and to ambulatory surgery centers (ASCs) by 1.2% for 2015.

If implemented, the payments for outpatient services would be increased by more than $5 billion and ASC payments would be boosted by more than $240 million next year.

The hospital fee increase was calculated based on a projected hospital market basket (a fixed list of items and services used to benchmark costs and track inflation) increase of 2.7% minus 0.6% in adjustments, whereas the ASC fee increase includes 2.2% adjustments. (Some of the

downward adjustments were mandated by the Accountable Care Act.) The fee changes would affect more than 4,000 hospitals and 5,300 ASCs that accept CMS reimbursements.

In other proposals, CMS said it plans to bundle some ancillary services in the ASCs. These would typically be minor diagnostic tests with a mean cost of less than $100, according to CMS, but could include some therapeutic services.

However, low-cost medication administration services, preventive services and certain psychiatric and counseling services would not be combined.

CMS is proposing to continue paying the average sales price (ASP) plus 6%

for non–pass-through drugs and biologics paid separately under the Hospital Outpatient Prospective Payment System.

CMS also plans to implement a process that would allow it to recover any overpayments that resulted from the submission of erroneous payment data by covered entitites that fail to correct the error requested by CMS. There would also be an appeals process if such entities want to challenge a CMS determination that the payment data were erroneous.

Ernest R. Anderson Jr., MS, RPh, a consultant in Brockton, Mass. who has testified before CMS on a wide range of reimbursement-related issues, noted that the ASP payment base will probably

get the most attention by pharmacists tasked with managing their drug budgets.

“We’re holding our own” on that reimbursement rate, he said. “But for many places around the country, it continues to be a challenge, because it often does not cover the cost of the medications.”

CMS is accepting public comment on the proposed policy changes and payment rates until Sept. 2 and a response will be issued around Nov. 1. Commenting instructions can be found in the proposed rule, available on the Office of the Federal Register website (http://1.usa. gov/1oEbNwY).

—Marie Rosenthal

Special Advertising Section

Aesynt American Health Packaging BD CutisPharma, Inc. Equashield ICU Medical, Inc. Medi-Dose/EPS Pacira Pharmaceuticals, Inc. Par Sterile Products, LLC PharMEDium Services ScriptPro Pharmacy Automation

The profiles in this section were submitted by the advertisers.

Aesynt Solving complex medication management challenges for health systems We understand that hospitals and health systems are facing complex issues. Helping solve those challenges is our top priority.

AT A GLANCE Address Aesynt 500 Cranberry Wood ds Drive Cranberry Township,, PA 16066 Phone: (800) 594-91145 Website: www.aesyn nt.com

History A customer-focused, innovative organization, Aesyntt provides hospitals and health systems with high-quality, cost-efffective and efficient solutions th hat safely deliver the right medication n closest to the patient. Founded in 1987, acquired by McKesson in 1996, an nd now owned

by Francisco Partnerrs, a technologyfocused private equiity firm, Aesynt has been a leader in pharmacy automation for more e than 25 years.

Enterprise Software Solutions: InsyteTM Medication Logistics Connect-Rx® Automation Decision n SupportTM IV Solutions: i.v.STATIONTM i.v.STATION ONCOTM i.v.SOFT® Central Pharmacy So olutions: ROBOT-Rx® MedCarousel® PROmanager-RxTM MedShelf-RxTM PACMEDTM PakPlus-Rx® NarcStationTM Point-of-Care Solutio ons: AcuDose-Rx® Anesthesia-RxTM

At Aesynt, our sole focus is partnering with our customers to develop long-term medication management strategies that will help them improve outcomes, build stronger businesses and manage change.

As a market leader in pharmacy automation and medication management, we know the health care industry inside and out, and understand how the evolving health care landscape affects you and your business. We were the first company to offer a robotic, barcode-based solution for medication dispensing, and we now boast an integrated, flexible portfolio of solutions to address every stage of medication delivery, whether in a single hospital or across multiple facilities, regardless of medication type. It’s how we help you deliver the right medications to the right place at the right time.

Gain Control of Your Medications System-Wide Recognizing the challenges associated with managing a medication supply chain across multiple facilities, we developed and launched Insyte™ Medication Logistics, a unique solution that helps you gain control of medication inventory system-wide. Insyte provides real-time visibility and valuation for all medications to reduce waste, improve shortage management, boost productivity and minimize cost. As a result, Insyte frees pharmacy resources to contribute more to clinical care and other mission-critical efforts.

Bridging the needs of pharmacy and supply chain, Insyte helps hospitals to optimize and actively manage medication inventory to support the service levels that nurses expect and patients deserve, while reducing costs and improving productivity, efficiency and inventory control.

Our professional services team helps you achieve success by implementing and optimizing inventory management best practices.

Supporting the Highest-Risk, Highest-Cost Area of Pharmacy IV compounding presents the greatest risk and the greatest cost for health systems, requiring many resources and detailed preparation, yet it is the least automated area of the hospital pharmacy. As the global leader in IV automation, Aesynt offers a full complement of cost-effective solutions—including robotics, workflow and analytics—to help pharmacists more safely and efficiently produce ready-to-administer IV medications. This helps support patient and clinician safety, reduce life-threatening medication errors, increase throughput and decrease costs associated with IV compounding and dispensing. These solutions also help enhance dispensing efficiency and eliminate waste, while supporting compliance with compounding and dispensing guidelines and regulations.

20

Corporate Profiles 2014

The Most Integrated, Flexible Portfolio of Solutions Thanks to a strong working relationship with our customers, we continually reinvest in our portfolio of pharmacy automation to better address your needs. With innovative hardware and software, we’re able to bring you one of the most integrated, comprehensive and flexible portfolios of central pharmacy and point-of-care solutions available today.

The benefits of automating the central pharmacy are many: substantial workflow efficiencies, better cost control, improved security, enhanced inventory management, and improved accuracy and efficiency in dispensing medications. Our goal is to reduce the pharmacy’s role in supply chain management, freeing pharmacy staff to focus on higher-value clinical care activities.

Designed to optimize inventory, increase productivity, improve ease of use and reduce diversion, Aesynt’s automated point-ofcare solutions bring medications closer to clinical areas. As a result, clinicians can deliver medications to patients more efficiently and safely—on the patient floor or in the operating room—through the most integrated, comprehensive and flexible portfolio available today.

Commitment to Customer Care Customer care and success are the founding principles of our new company. We’ve invested significant resources to enhance our working relationships through Aesynt Care™, a closed-loop, multidisciplinary approach designed to help ensure that you are getting the best support from our people and the most value out of your automation investment.

Every customer has a dedicated resource at every phase of our partnership. We facilitate smooth transitions from the time you purchase your automation solution through implementation, and most importantly, continue to provide the support and guidance for successful adoption and usage by your team. This helps ensure a positive return on investment for your automation solution.

Special Advertising Section Pharmacy Practice News

American Health Packaging Pharmacies juggle many critical tasks. Although patient safety is top priority, operational efficiency is important, too. Institutions seek to provide barcoded medications, while minimizing packaging tasks to enable barcode medication administration. American Health Packaging (AHP) can support you at this ”key intersection” of patient safety and operational efficiency. Our unit-dose line is the largest in the industry, with continued growth to support your needs. And we have many more items coming soon via our Pharmacy Unit Dose Plus line!

There are many benefits to AHP’s prepackaged unit-dose products: Safety. AHP is a Current Good Manufacturing Practices (cGMPs) facility, which ensures regulatory compliance. Our products are packaged in a regulated and safe environment. Our packaging professionals are adept at ensuring the product’s lot number, National Drug Code (NDC) and expiration date are recorded correctly and scan easily.

Efficiency. Health systems are experts in the care of patients.

Often, however, they are not as well suited or staffed for packaging tasks. Buying prepackaged unit-dose products allows staff to better focus on core competencies.

Savings. Purchasing prepackaged unit-dose products often provides a cost savings to hospital pharmacies when staffing and other overhead costs are considered.

Liability Management. Packaging in the hospital setting shifts the legal burden of accuracy in packaging and dispensing to hospital associates and dispensing caregivers. Prepackaged product, however, maintains a legal burden to be correct as delivered to the hospital.

Exclusive Unit-Dose Items. AHP focuses on providing unit-dose items to the market where none existed in a barcoded format. In fact, our line has more than 90 exclusive items. If you’re having a difficult time finding a prepackaged unit-dose item, be sure to check with AHP!

Prepackaged unit-dose products provide efficiency to your pharmacy by avoiding in-house packaging tasks.

Special Advertising Section Pharmacy Practice News

AT A GLANCE Address American Health Packaging 2550-A John Glen nn Ave. Columbus, OH 432 217 Phone: (800) 707--4621 Fax: (614) 492-04 448 Website: www.americanhealthpackaging.com

Products Barcoded unit-dos se products AHP offers a full line of unit-dose products, many of which are industry exclusives.

And … Coming Soon!

AHP will be broadly launching its new Pharmacy Unit-Dose Plus line of select and difficult-to-find unit-dose products later this year.

This is a new, select line of unit-dose products. Like our core line, these items will increase safety while adding efficiency to your pharmacy operations. Unit-Dose Plus items, however, are exclusively offered in a barcoded package format by AHP. RIGHT SIZE—We know waste is an issue for you, therefore, our unit-dose products are packaged in smaller count-size cartons to avoid both waste and returns.

ADDING VALUE—When all costs associated with in-house or third-party packaging are considered, Unit-Dose Plus is a lowercost alternative for obtaining barcoded ready-to-scan oral solids for your patients.

Unit Dose Plus, a new offering of “right-sized” select, difficult-to-find unit-dose products is coming soon from AHP!

Corporate Profiles 2014

21

BD AT A GLANCE Address BD 1 Becton Drive Franklin Lakes, NJ 07417 Phone: (201) 847-6800 Website: www.bd.co om

Products Medical supplies, dev vices, laboratory instruments, antibod dies, reagents and diagnostic products

Since 1897, BD has been committed to making healthcare more effective, efficient and safer. BD is among the world’s leading suppliers of medical devices and a leading innovator in injection- and infusionbased drug delivery devices. Our focus on pharmacy builds on this legacy. Today’s pharmacy leaders must balance quality improvements and compounding legislation changes with drug shortages and budget reductions while providing quality patient care. To address these challenges, BD offers a comprehensive portfolio.

Count on BD pharmacy solutions now…for healthcare’s tomorrow.

Vincent A. Forlenz za Chairman, Chief Executive Officer and President

Patient Safety

Despite best efforts, patient safety can be compromised during medication preparation and delivery. BD’s broad, innovative portfolio can help.

BD Simplist™ ready-to-administer pre-filled injectables, manufactured by BD’s wholly-owned subsidiary – BD Rx and supplied in our state-of-the-art pharmaceutical plant, are designed to improve patient care and safety by decreasing the number of steps in the traditional vial and syringe injection sequence1, reducing the potential risk of medication error.

BD Cato™ Medication Workflow Solutions is an innovative gravimetric-based, barcode verification-enabled workflow solution that enables safe and accurate preparation of IV medications by detecting wrong drug and dose errors in real time.

BD PhaSeal™ Closed System Transfer Device is designed to prevent microbial ingress, thus protecting the sterility of drug vial contents.

BD Medication Preparation Products, including BD blunt fill and filter needles help to facilitate compliance with USP <797> standards, and minimize needlestick injuries due to higher skin penetration forces.

Healthcare Worker Safety OSHA reports that more workers are injured in healthcare than any other sector2. BD’s offers solutions designed to prevent occupational exposure.

BD PhaSeal™ Closed System Drug Transfer Device is proven to reduce exposure to hazardous parenteral medications from pharmacy to administration3. The BD PhaSeal System is airtight and leak-proof, and mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, minimizing individual and environmental exposure.

BD Disposal Solutions include collectors in a variety of colors and sizes specifically designed to safely contain sharps, non-hazardous pharmaceutical, Chemotherapy and Hazardous RCRA waste.

patient care and safety by decreasing the number of steps in the traditional vial and syringe injection sequence1, reducing the potential risk of medication error.

About BD BD is a leading medical technology company that partners with customers and stakeholders to address many of the world’s most pressing and evolving health needs. Our innovative solutions are focused on improving drug delivery, enhancing the diagnosis of infectious diseases and cancers, supporting the management of diabetes and advancing cellular research. We are nearly 30,000 associates in 50 countries who strive to fulfill our purpose of “Helping all people live healthy lives” by advancing the quality, accessibility, safety and affordability of healthcare around the world. For more information, please visit www.bd.com.

About BD Rx Inc. BD Rx Inc. is a wholly-owned subsidiary of BD (Becton, Dickinson and Company). Based on a strategic decision and long-term investment in the acute care generic injectables category BD applied its expertise in manufacturing excellence, high-quality products and service delivery to the manufacturing of high-demand generic pharmaceuticals. This is a logical extension of BD’s demonstrated 12-year history of continuous, reliable supply of our Flush platform and existing leadership position in glass prefillable syringe manufacturing and should be seen as an addition to our current pharmaceutical offerings, as it will enable us to offer a broader range of treatment options for customers. With the new BD Simplist™ ready-to-administer, prefilled injectables, BD Rx is aiming to redefine injectable drug administration practice. We envision safe patient care and efficient clinical applications and believe this is the future of injectables. For more information, please visit www.bdrxinc.com.

BD and BD Simplist are trademarks of Becton, Dickinson and Company. ©2014 BD. 07/14 MSS0612 BDRx0157 1.

Workflow Efficiency and Cost Containment Today’s healthcare systems must deliver better outcomes, while still controlling costs. BD offers a portfolio that helps.

BD Cato™ Medication Workflow Solutions help improve efficiency and contain cost by standardizing the medication preparation workflow, automating documentation and optimizing drug utilization to reduce drug waste.

BD PhaSeal™ Closed System Drug Transfer Device is FDA ONBcleared and proven to prevent microbial ingress for up to 168 hours4 and may extend the sterile life of drugs to enable drug vial optimization. This may lead to better drug utilization, lower overall cost of operations and reduced waste5.

BD Simplist™ ready-to-administer pre-filled injectables, manufactured by BD’s wholly-owned subsidiary – BD Rx and supplied in our state-of-the-art pharmaceutical plant, are designed to improve

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Corporate Profiles 2014

Potter P, Perry A, Stockert P, Hall A. Vial & Syringe Injection Steps. Basic Nursing, 7th ed. (St. Louis, MO: Mosby, 2010) 442-447.

2. United States Department of Labor. Occupational Safety and Health Administration (OSHA). “Safety and Health Topics.” https://www.osha.gov/SLTC/healthcarefacilities/ 3. Wick et al. “Using a closed-system protective device to reduce personnel exposure to antineoplastic agents” Am J Health-Syst Pharm. 2003;60:2314-2320.

4. Edwards et al. “Cost savings realized by use of the PhaSeal closed-system transfer device for preparation of antineoplastic agents” J of Oncol Pharm Practice 2013;19(4):338-347 5. Pedersen CA, Schneider PJ, Scheckelhoff DJ. ASHP national survey of pharmacy practice in hospital settings: Dispensing and administration – 2011. Am J Health Syst Pharm. 2012;69(9):768-785.

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CutisPharma, Inc. CutisPharma, Inc., brings innovation and value to the prescription-compounding sector of hospital and health-system pharmacies. Patient-specific – Compounding Kits simplify the entire process by quickening preparation and helping facilitate reimbursements. What typically takes compounders up to 15 minutes to do now takes just minutes.

Greater efficiencies in the compounding process bring multiple financial and clinical gains to hospital and health-system pharmacies. By using pre-measured, pre-weighed unit-of-use prescription compounding kits, pharmacies and nurses save significant staff time in preparation, help lower the total costs of compounding, and refine their just-in-time inventories to ensure ingredients are on hand when needed and ready to use over longer periods of shelf life. All dispensing containers are bar-coded for convenient bedside scanning.

Clinically, the packaged reagents help deliver consistent accuracy of the compounded admixtures and speed medication delivery to patients, if compounded according to instructions, because they’re easier and quicker to use than the typical laborious processes. These benefits, in turn, may lead to better patient health outcomes. The kits also help facilitate compliance with USP <795>.

“Industry-wide savings can be vast. [The] FDA estimates 30 million hospital-outpatient and retail compounding prescriptions are filled per year. Inpatient figures are also significant, yet harder to pinpoint because they lack a single NDC number,” said Jim Nagle, Vice President–Business Development at CutisPharma.

The NDC number imprinted on each end-use container in every CutisPharma FIRST® – Kit facilitates third-party reimbursement for health systems. The single NDC number for the entire kit may also improve patient safety, because of minimized dispensing errors, suiting the growing number of inpatient and outpatient pharmacies that bar-code prescriptions from point of dispensing to point of care.

New Oral Solution Prescription Compounding Kits FIRST® - Vancomycin compounding kits make pharmacy compounding easier. With FIRST®– Vancomycin, the oral solution is compounded within a minute by adding the pre-measured white grape-flavored solution to the pre-weighed vancomycin hydrochloride powder bottle and shaking it. The pleasant white grape flavor helps mask the typical bitterness of vancomycin hydrochloride. These compounding kits are provided in two concentrations: 25 mg/mL (5 and 10 oz. sizes), and 50 mg/mL (5, 7 and 10 oz. sizes) for MultiFlex™ (multiple and flexible) dosing.

Compounding Kits for Widely Used PPIs CutisPharma, Inc., also offers FIRST® – Omeprazole and FIRST® – Lansoprazole Patient Specific Oral Suspension Compounding Kits. These kits will help pharmacists quickly dispense these compounded prescriptions containing widely used proton pump inhibitors (PPIs). Traditionally, compounded omeprazole and lansoprazole oral suspensions can take up to several hours to prepare and have an unpleasant taste.

With FIRST® – Omeprazole and FIRST® – Lansoprazole, pharmacists need only add the liquid suspension to the powder, shake, and then within minutes can dispense to the patient with improved flavoring.

“We invested a lot of time to develop these new suspension kits.

The results are a pleasant-tasting strawberry-flavored medication with adequate stability once compounded,” said Dr. Indu Muni, founder,

AT A GLANCE Address

FIRST® Vancomycin Solution kits are provided in two concentrations: 25 mg/mL, 5 oz. and 10 oz sizes, and 50 mg/mL, 50 oz, 7 oz. and 10 oz. sizes.

chairman and CEO of CutisPharma, Inc. “These products offer another advantage for hospital use: Since the suspensions are made using powders and not pellets, our new compounded suspensions should flow more easily through nasogastric (NG) tubes, with minimal clogging compared to current practice. Also, our three different sizes of packaging, 3 oz., 5 oz. and 10 oz., provide considerable prescribing flexibility.”

Compounding Kits For Often-Filled ‘Magic Mouthwashes’

CutisPharma, Inc. 68 Cummings Park Woburn, MA 0180 01 Contact: Jim Nagle, Vice President– Business Developm ment Phone: (781) 935-8 8141 ext. 120 Email: JNagle@cutispharma.com Website: www.cuttispharma.com

Patient-Specific c Prescription Compounding Kits FIRST® - Vancomyc cin 25 Solution 150/mL 5, 10 oz.

FIRST® - Vancomyc cin 50 Solution 150 mL 5, 7, 10 oz.

FIRST® – Omeprazole Suspension: 3, 5, 10 oz.

FIRST® – Lansoprazole Suspension: 3, 5, 10 oz.

FIRST® – Mouthwassh BLM: 4, 8 oz.

FIRST® – BXN Mou uthwash FIRST® – Duke’s Mo outhwash FIRST® – Mary’s Mo outhwash FIRST® – 10% Hydrrocortisone in Ultrasound Gel FIRST® – Progesterrone Vaginal Suppository USP: 25, 50, 100, 200, 400 mg FIRST® – Testosterone MC: 2% Testosterone in White Moisturizing Cream Base FIRST® – Testosterone: 2% Testosterone in White Petrolatum

CutisPharma, Inc., offers convenient kits that make dispensing some of the most commonly prescribed suspensions a simple, easy process.

Commonly known as ‘Magic Mouthwashes,’ the products include: • FIRST® – Mouthwash BLM (Benadryl®, lidocaine and Maalox®) in two sizes • FIRST® – Mouthwash BXN (diphenhydramine, lidocaine and nystatin) • FIRST® – Duke’s Mouthwash (diphenhydramine, hydrocortisone and nystatin) • FIRST® – Mary’s Mouthwash (diphenhydramine, hydrocortisone, nystatin and tetracycline) Each FIRST® Kit has everything needed to compound one prescription from one prescriber for one patient. They include pre-weighed powders and a pre-measured suspension. The pharmacist needs only to add the powders to the liquid suspension, shake and dispense.

“The company now has a wide range of FIRST® ‘Magic Mouthwash’ formulations to choose from, particularly for the most commonly prescribed and used,” Dr. Muni said.

FIRST® products save dispensing time and can be compounded by the pharmacist while the patient waits, thus increasing customer satisfaction. Using FIRST® Mouthwash kits, the pharmacist can compound a prescription faster than those prepared in the conventional way.

Growing Portfolio Serves Compounding Needs The CutisPharma Kit portfolio is growing to meet pharmacy’s increasing reliance on compounding. To meet the need for efficiencies, safety and convenience, all FIRST® Patient-Specific Compounding Kits follow the simple rule of “one prescription from one prescriber for one patient.”

CutisPharma, Inc., now has 24 proprietary prescription compounding kits on the market: five progesterone suppository compounding kits, two testosterone kits, one hydrocortisone kit, five Magic Mouthwash kits, three omeprazole suspension kits, three lansoprazole suspension kits and five vancomycin solution kits. Several more compounding kits are in the planning stages. The use of FIRST® Unit-of-Use Prescription Compounding Kits facilitates compliance with United States Pharmacopeia (USP) Chapter <797>.

FIRST® – Omeprazole and FIRST® – Lansoprazole Suspension Unit-ofUse Compounding Kits in 3, 5 and 10 oz. sizes.

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23

Equashield AT A GLANCE Address Equashield 99 Seaview Blvd.

Port Washington, NY Y 11050 Phone: (516) 684-82 200 Website: www.equasshield.com

Hazardous drugs, such as chemotherapy drugs, and others with antineoplastic agents, present an occupational hazard to those who handle them. Occupational exposure to hazardous drugs can lead to both acute and chronic effects, ranging from skin irritation, to more serious reproductive complications and even some forms of cancer.

The CDC’s National Institute for Occupational Safety and Health (NIOSH), the US Pharmacopeia EQUASHIELD® II - Cllosed System USP <797> and the recently added USP <800>, Transfer Device the American Society of Hospital Pharmacists For medical inquiriess related (ASHP) and the Oncology Nursing Society (ONS) Equashield, contact Tammy Balzer, have all recognized and made recommendations Director of Clinical S Services USA based on the potential health risks associated tammyb@equashield d.com with occupational exposure to hazardous drugs.

While the dangers of hazardous drugs are often invisible to the naked eye, common practice when handling hazardous drugs creates multiple routes of exposure that can be released to and contaminate the environment despite the use of standard personal protective equipment [PPE], safety cabinets and procedures. Since hazardous drugs have adhesive characteristics, traces can often be carried out of the workspace, and are often found on unlikely surfaces like keyboards, doorknobs and other surfaces outside of the designated areas for drug compounding and delivery.

NIOSH defines CSTDs as “a drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapor concentrations outside the system,” and the FDA recently created the ONB category that clears devices as “closed antineoplastic and hazardous drug reconstitution and transfer system.”

CSTDs, which typically encapsulate the syringe and vial into one closed system, provide a vital layer of protection against hazardous drug exposure. In fact, studies have shown that using a CSTD has significantly reduced the levels of surface contamination in labs, pharmacies and hospitals.1 However, not every CSTD provides the same level of protection, and not every CSTD is equally effective at closing off the major routes of exposure.

Equashield’s closed systems are among the only CSTDs in the world cleared under the FDA’s ONB code, confirming that they meet the requirements of a truly closed system.

Equashield’s first and second-generation systems are also the first to be substantiated to FDA and defined in FDA cleared labeling as preventing microbial ingress up to 7 days.

Equashield’s system was created with a simplified, elegant design that provides ease-of-use, and covers more routes of exposure to hazardous drugs.

One of the major routes of exposure, the syringe plunger, is uniquely covered by Equashield’s system. Studies show that a typical standard syringe plunger is contaminated many times after a drug transfer when it is drawn back out.

When pharmacists use standard syringes, and even when they use standard syringes that are found in other closed systems, they can be exposed to hazardous drugs due to plunger contamination, and they risk major spills, as these plastic syringes can be pulled out of the barrel completely.

Equashield’s flagship CSTD, EQUASHIELD® II, introduced in late 2013, uses a metal plunger instead of a standard plastic plunger. The metal rod runs through the center of the barrel, and is

Products

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Corporate Profiles 2014

fully encapsulated and sealed in. This design prevents plunger contamination and it cannot be removed from the barrel, so it also prevents potential spills.

The metal rod plunger cannot come in contact with the inner walls of the barrel, and therefore, remains uncontaminated by the barrel sides. In this way, Equashield’s CSTD is the only CSTD to cover this major route of exposure by minimizing plunger contamination to undetectable levels.2 Equashield developed its fully encapsulated syringe system with an internal, self-contained pressure equalizer and sterile air chamber found within the syringe barrel. This feature allows for a more streamlined design that is intuitive for those using it in the compounding, transferring and administration of hazardous drugs.

Equashield’s CSTD design also innovates with its connection mechanism. Whether connecting the syringe to a vial adapter, infusion bag, or infusion tubing, each Equashield adapter and syringe are designed for safe and easy connections made in one smooth motion.

Committed to protecting healthcare professionals, Equashield’s devices are qualified to the highest industry standards. Equashield’s CSTD is simple, with an elegant design and ease-of-use, which make it the CSTD of choice by hundreds of healthcare facilities in North America, Europe, Asia-Pacific, and the Middle East.

Equashield is a privately held medical device company with more than 140 employees. With offices located in Port Washington, New York, and its manufacturing facilities located internationally, the company has a growing global footprint, and is committed to continuing to protect healthcare professionals from exposure to hazardous drugs.

References 1.

http://www.ncbi.nlm.nih.gov/pubmed/19965949

2. http://opp.sagepub.com/content/early/2014/03/05/1078155214526428.full. pdf+html

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ICU Medical, Inc. ICU Medical helps you maximize clinician and patient safety with easy-to-use needlefree technology designed to minimize exposure to hazardous drugs and maintain drug sterility. These needlefree solutions include the world’s only needlefree closed system transfer device (CSTD) FDA 510(k) cleared for both pharmacy compounding (ONB) and patient administration (FPA) applications, as well as a CSTD with the lowest implementation cost of any other on the market.

Minimize Exposure to Hazardous Drugs While Maximizing Medication Safety Keep yourself safe from exposure to hazardous drugs and maintain drug sterility with our complete line of needlefree safehandling solutions.

These convenient, needlefree CSTDs and automated drug compounding systems maintain mechanically and microbiologically closed systems to help you stay safe and in compliance with recommended guidelines during the sterile preparation of IV medications.

The Most Cost-Effective Way To Start Protecting Yourself Today With the lowest implementation cost, ICU Medical’s ChemoClave® CSTD makes the decision to start improving IV medication safety a whole lot easier. The easy-to-use ChemoClave CSTD is comprised of a selection of vial adapters that mechanically prohibit the transfer and escape of environmental contaminants, as well as a selection of needlefree bag spikes and primary add-on and administration sets. ChemoClave also generates less biohazardous waste than competing systems and helps keep you and your patients safe during every step of the hazardous drug handling process.

AT A GLANCE Address ICU Medical, Inc. 951 Calle Amanece er San Clemente, CA A 92673 Phone: (800) 824-7890 Fax: (949) 366-83 368 Website: www.icumed.com

Enhance Your Pharmacy Workflow Efficiency should not have to come at the expense of clinician and patient safety. That’s why we developed a full line of safe handling solutions that complement your workflow, not complicate it. Our needlefree CSTDs help speed preparation times by eliminating the need to assemble multiple components, and user-controlled automated compounding systems with integrated barcode scanning help increase the accuracy and speed of data entry while improving workflow traceability.

Setting a Whole New Standard for Hazardous Drug Safety With the ChemoLock™ needlefree CSTD, it has never been easier to keep yourself safe from exposure to hazardous drugs. ChemoLock’s intuitive and easy-to-use system locks with a single motion and an audible click, ensuring a safe and secure connection to minimize exposure to hazardous drugs and protect the patient preparation from contamination. ChemoLock is also the first and only needlefree CSTD to receive FDA 510(k) clearance under the ONB product code, keeping you and the drugs you mix safer while ensuring safehandling compliance.

With the lowest cost to implement of any CSTD, ChemoClave makes the decision to start improving IV medication safety easier.

Automate Your Sterile Drug Compounding Process The Diana™ hazardous drug compounding system lets you reduce the risk for exposure to hazardous drugs while maintaining drug sterility and minimizing physical stress to pharmacists and technicians.

Using many of ICU Medical’s proven ChemoClave closed system components, Diana fits under the hood of your existing biologic safety cabinet to protect clinicians from exposure to hazardous drugs and accidental needlesticks.

Commitment to the Safety of Oncology Pharmacists Bringing new and innovative technologies to oncology pharmacists and technicians is at the core of who we are and what we do. We are committed to providing easy-to-use needlefree solutions that generate less biohazardous waste and lower costs while helping keep clinicians and patients safe.

Only ICU Medical gives you simple, safe, and secure needlefree closed systems; CSTDs; and automated drug compounding systems to help enhance health care worker safety and comply with OSHA, NIOSH, ASHP, ISOPP, ONS, APHON and USP <797>. Contact us today to learn how we can help you improve your IV medication safe handling process by calling (800) 824-7890 or by visiting www.icumed.com.

With ChemoLock, one click is all it takes to minimize exposure to hazardous drugs and maximize medication safety.

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Corporate Profiles 2014

25

Medi-Dose/EPS AT A GLANCE Address Medi-Dose/EPS 70 Industrial Drive Ivyland, PA 18974 Phone: (800) 523-89 966 Fax: (800) 323-8966 6 Email: info@medidos se.com Website: www.medid dose.com

For more than 40 years, the Medi-Dose System has been used by facilities of all sizes to package solid oral, unit-dose medications. With input from pharmacists and technicians, Medi-Dose has been designed to be the easiest, fastest and most cost-effective way to unit-dose and barcode your inventory.

Medi-Dose began in 1971, when Milton Braverman, a former pharmaceutical company territory manager, formed his own company. Robert Braverman, President and Director of MarketProducts ing, remembers, “My dad was acutely aware Medi-Dose® (Solid) a and of the requirements of hospital pharmacy. He ® TampAlerT (Liquid)) Oral saw the need for inexpensive, manual unit-dose Unit-Dose Packaging g packaging allowing hospitals to convert from Medi-Cup® PLUS pac ckaging for traditional dispensing. He developed systems to extended beyond-usse dating package, handle and dispense predetermined amounts of medication so they would be acces® MILT by Medi-Dose unit-dose and sible for one regular dose.” bar-coding software Although familiar today, launching the idea of LiquiDose® labeling, IV additive and unit dose was a huge problem the new company filtration products faced. “We were one of the pioneers, the innovators promoting unit-dose in hospitals,” Robert ® Nultraviolet ultravio olet light Braverman recalled. “Due in part to Medi-Dose’s inhibitant bags educational efforts, pharmacists and nurses Steri-Dropper sterile e ophthalmic accepted the validity of unit dose.” dropper bottles Inexpensive, Easy and Flexible: Because of its unique Cold-Seal technology, the Medi-Dose High Alert and IV Lin ne Tracing Labels System is simple to use and requires no special Resealable bags, botttles and other in-service training or additional space. Medi-Cup pharmacy supplies and a disposables blisters are available in a variety of sizes and styles to accommodate virtually any medication or storage system. Ultraviolet-inhibitant blisters provide additional protection from light. Plus, a combination of special blister plastics with aggressive tamper-evident label adhesives provides either six-month or one-year beyonduse dating for all your unit-dose packaging needs.

• Sealed units can be left in sheets or easily torn down to individual doses.

• Medi-Cup Blisters are available in five sizes to accommodate the largest medications or the smallest storage spaces.

• Lid-Label Covers are available in 8 1/2˝ × 11˝ laser sheets of 25 doses or 4˝ × 6 1/4˝ direct thermal sheets of five doses.

Using our MILT 4 software, you can label and identify all your medication... complete with graphics and a bar code.

• Laser Lid-Label Cover Sheets are available in 12 colors to facilitate color-coding of medications.

• New Oval Blisters and Lid-Label Covers have been designed to fit your dispensing machines and storage cabinets.

• All Medi-Cup Blisters and Lid-Label Covers work with our MILT 4 software, which can be used for all your barcoding and labeling needs.

Adapts to Your Needs: With our new 64 bit–compatible MILT 4 software, you can design your labels any way you want (for solids, liquids, syringes ampules, IVs—even equipment and supplies). In addition to the ability to use graphics, special fonts, tall man lettering, shapes—even logos and symbols—to better identify your medications, MILT 4 has been designed to easily create barcodes with the information that your barcode-enabled point-of-care and barcode medication administration systems require. Popular 1-D and 2-D barcode formats can be created with National Drug Code numbers, expiration dates, lot numbers and special codes.

To get started, all you will need is: 1. Medi-Cup Blisters: 13 styles to suit your packaging needs.

2. Lid-Label Covers: Laser or Direct Thermal labels to seal the blisters.

3. MILT 4 software: Design and manage Lid-Label Cover printing.

4. Fil-Form and Roll-E-ZY: Aligns Lid-Label Covers to the Medi-Cup Blisters and ensures a positive seal between labels and blisters.

Inexpensive. Flexible. Tamper-Evident. If you are looking for a system to handle any or all of your unit-dose or barcoding needs, then the Medi-Dose System is a perfect fit for you!

NEW 64-bit compatible MILT4 software.

Medi-Dose is simple to use and requires no special in-service training.

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Corporate Profiles 2014

Special Advertising Section Pharmacy Practice News

Pacira Pharmaceuticals, Inc. Pacira Pharmaceuticals, Inc. is an emerging specialty pharmaceutical company focused on the clinical and commercial development of new products to address the needs of acute care practitioners and their patients. Pacira is driven by a dynamic workforce committed to optimizing patient care and satisfaction in the acute care setting, with a special focus on improving outcomes in postsurgical pain management.

A Proprietary Drug Delivery Platform The cornerstone of the Pacira product portfolio is DepoFoam®, a proprietary drug delivery platform designed to extend a medication’s duration of action without altering its molecular structure. The DepoFoam carrier matrix is made up of multivesicular liposomes that encapsulate a drug. Each chamber is separated by lipid membranes that naturally erode to release the drug over a desired period of time.

Clinical Utility Across a Broad Range Of Potential Applications EXPAREL has broad applications across multiple surgical specialties, as well as in the anesthesiology arena, including use as an infiltration into the transversus abdominis plane for postsurgical analgesia following abdominal procedures. In May, Pacira submitted a Supplemental New Drug Application to the FDA for a nerve block indication for EXPAREL based on positive data from a Phase III study assessing the safety and efficacy of EXPAREL in femoral nerve block for total knee arthroplasty.

The Pacira Advantage

AT A GLANCE Address Pacira Pharmaceuticals, Inc. 5 Sylvan Way Parsippany, NJ 07 7054 (973) 254-3560 www.Pacira.com For more informattion on EXPAREL, visit www.EXPARE EL.com For medical inquirries related to EXPAREL, conta act Medical Informatio on at medinfo@pacira a.com or 1-855-RX-EXPAREL (1-855-793-9727)

Discovery, innovation and proprietary expertise are the hallmarks of the Pacira competitive advantage. The company not only holds the exclusive rights and expertise to DepoFoam, but owns the unique distinction of being the only company in the world with the ability to manufacture DepoFoam-based products, such as EXPAREL, on a large commercial scale. With steadily increasing demand and a growing list of potential clinical applications, Pacira and EXPAREL are poised to become vital fixtures in the postsurgical pain management arena.

For more information about Pacira Pharmaceuticals Inc., visit www. pacira.com. *Pivotal studies have demonstrated the safety and efficacy of EXPAREL in patients undergoing and bunionectomy procedures.

Important Safety Information For EXPAREL A First of Its Kind, Single-Dose Local Analgesic In 2012, Pacira successfully launched EXPAREL® (bupivacaine liposome injectable suspension), the first and only DepoFoam-based local analgesic.

Indicated for administration into the surgical site to produce postsurgical analgesia, a single dose of EXPAREL provides nonopioid pain control with reduced opioid requirements for up to 72 hours* without the need for catheters or pumps.1

Shifting the Postsurgical Pain Management Paradigm The launch of EXPAREL is bolstered by a robust Phase IV clinical program, which builds a compelling case for EXPAREL as the foundation of an opioidsparing multimodal postsurgical pain management regimen. Recently published national and regional retrospective analyses2,3 of more than 350,000 postsurgical patients receiving opioids concluded that those who experienced opioid-related adverse events had both longer hospital lengths of stay and higher hospitalization costs. The company’s efforts are buoyed by a groundswell movement led by government and independent health care organizations to mitigate potentially fatal side effects related to opioid use by recommending a shift toward opioid-sparing pain regimens, especially in high-risk postsurgical patients.

EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age.

Non–bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally.

The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours after administration of EXPAREL. Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anewsthetics normally, are at a greater risk for developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting.

1. Gorfine SR, et al. Diseases of the Colon & Rectum.

2011;54(12):1552-1559.

2. Oderda GM, et al. Journal of Pain & Palliative Care Pharmacotherapy. 2013;27(1):62-70.

3. Kessler ER, et al. Pharmacotherapy. 2013;33(4):383-391.

PP-EX-US-0185

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Corporate Profiles 2014

27

Par Sterile Products, LLC “Providing patients and customers with uncompromising quality and value.”

Quality You Can Depend On

AT A GLANCE

The legacy of Par Sterile Products reaches

back to the birth of the American pharmaceutical industry at the turn of the 20th Address century. With a sterile manuPar Sterile Products,, LLC facturing facility located in n Morris Corporate Center 2 Rochester, Mich., Par Steri le One Upper Pond Rd., Building D, Products possesses an 3rd Floor Parsippany, NJ 0705 54 unparalleled reputation for high-quality prodCustomer Service ucts and an impeccable (877) 547-4547 record of regulatory compliance. Our iconic Drug Safety/Medic cal Information brands, such as Aplisol® (800) 828-9393 Opttion 3 and Adrenalin®, have been relied on by physiChief Executive Officer cians and patients for Paul Campanelli decades. While proud of our heritage, we are even prouder of the great things we are accomplishing today.

In an injectables world frequently plagued by compliance issues and product shortages, Par Sterile Products stands as a highly regarded partner with exemplary trade service levels and an impeccable record of regulatory compliance. Every week in America, more than 1 million Par prescriptions are dispensed, including Par Sterile Products.

In return for the trust that is placed in us, we are committed to providing products of uncompromising quality. In fulfilling this mission, we deliver value to our customers and the physicians and patients who rely on us.

and distributing safe, innovative and cost-effective branded and generic aseptic injectable pharmaceuticals that help improve patient quality of life. We also provide contract manufacturing services to our partners in the biopharmaceutical and pharmaceutical industry. Today, our company’s sales, together with Par Pharmaceutical, Inc., and its other subsidiaries, place it among the top five largest generic pharmaceutical companies in the United States. At A Par Sterile Products, our most important resource iss the talent and dedication of our nearly 500 employee es, each of whom is part of a culture that values integrity, customer focus, teamwork v and performance.

Promising Product Pipeline Par Sterile Products currently markets a portfolio of 14 specialty injectable products, including Brevital®, Dantrium®, Pitocin® and zoledronic acid. Since 2012, Par Sterile Products has launched nine new S products. We possess one of the most promising new product pipelines in the injectable space, having developed a pipeline currently consisting of 34 products, 17 of which have already been submitted for FDA approval. We expect at least a half-dozen more ANDA filings before year end, fueled by our commitment to investment in research and development.

At Par Sterile Products, we are large enough to maintain a significant trade presence, yet agile enough to provide maximum attention to our customers, and we remain poised to continue our impressive track record of success. For more information, please visit www.parpharm.com.

PAR—People Achieving Results!

Partners for Health Care Excellence Par Sterile Products, LLC, a subsidiary of Par Pharmaceutical, Inc., is at the forefront of developing, manufacturing, marketing

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Corporate Profiles 2014

Special Advertising Section Pharmacy Practice News

PharMEDium® Services At PharMEDium, we are committed to patient safety. We take extraordinary measures to ensure the safety and sterility of our services. Count on PharMEDium to provide sterile preparations with the highest levels of quality assurance and patient safety in mind. From the use of FDAapproved sterile components to proven leadership in R&D, quality, labeling/packaging and service, you can expect customized admixtures of the highest quality.

As the leader in the admixture business for more than a decade, our company has been an advocate for you and your patients. PharMEDium was one of the first entities to register voluntarily with the FDA as a Human Drug Compounding Outsourcing Facility under

Section 503B of the Federal Food, Drug, and Cosmetic Act. PharMEDium provides sterile compounded preparations to hospital pharmacies as an extension of their sterile preparation for IV and epiAddress dural therapy requirements, using FDA-approved PharMEDium Serv vices sterile drugs and sterile containers. PharMEDium Two Conway Park helps meet the demands placed on hospitals to 150 North Field Drrive ensure that patients receive their medications on Suite 350 time and as prescribed.

Lake Forest, IL 60 0045 It is our mission to be the preeminent provider Phone: (800) 523--7749 of choice for hospital customers and to attain Website: www.pha armedium.com the highest degree of integrity in the compounding of sterile preparations.

Services Labeling: Our complete and total commitment Delivering only the highest quality, to advancing patient safety is embodied through ready-to-use comp pounded sterile first-in-class labeling, packaging and cuttingpreparations for use within the edge barcode scanning technology designed to medical triad of ca are. help reduce the potential for medication errors.

Service: As a PharMEDium customer, you Pain managementt PCAs and epidurals; labor an nd delivery; not only deserve the highest level of quality, nerve block and lo ocal anesthetics; you deserve the highest level of service. That’s OR anesthesia syrringe preparations; why we assign a team of professionals to each ICU services. customer. Your team will supply what you need, from the emergency department to the operating room to the patient’s room.

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Corporate Profiles 2014

29

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30

Corporate Profiles 2014

Special Advertising Section Pharmacy Practice News

Clinical 31

Pharmacy Practice News • August 2014

Oncology

Navigating the Changing Melanoma Landscape New Orleans—Since 2011, four new medications have arrived on the scene for treating patients with melanoma.

That’s good news for a potentially deadly cancer that had not seen a new drug approval in the preceding decade. Still, the glut of new treatment options does pose significant management challenges, according to several hematology/ oncology pharmacists.

Vananh Trinh, PharmD, BCOP, a clinical pharmacy specialist at the University of Texas MD Anderson Cancer Center, in Houston, said that sequencing the available agents could be a particularly thorny issue. When patients with melanoma first present, Dr. Trinh noted, should they be started on highdose interleukin-2 (IL-2), one of the mainstays of therapy? Or should one of the newly approved agents—ipilimumab (Yervoy, Bristol-Myers Squibb), vemurafenib (Zelboraf, Genentech), dabrafenib (Tafinlar, GlaxoSmithKline) or trametinib (Mekinist, GlaxoSmithKline)—be the first choice?

These can be tough decisions. Fortunately, patient selection criteria (e.g., mutation type and tolerance to side effects) and clinical trial data often will point clinicians in the right direction, Dr. Trinh said during a melanoma update session at the 2014 annual conference of the Hematology/Oncology Pharmacy Association (HOPA).

The Drugs and Their Class Ipilimumab is a monoclonal antibody that blocks cytotoxic T lymphocyte– associated antigen 4 to enhance an antitumor T-cell response. In a clinical trial, patients who received the drug had a better median overall survival (OS) than patients receiving a glycoprotein 100 peptide vaccine (10.1 vs. 6.4 months; hazard ratio [HR], 0.66; P=0.003; N Engl J Med d 2010;363:711-723). This is an achievement, considering that the older standard-of-care regimens, such as dacarbazine, temozolomide, highdose IL-2, combination chemotherapy and biochemotherapy, have never been proven to improve OS in randomized Phase III trials, Dr. Trinh said.

Vemurafenib and dabrafenib are BRAF kinase inhibitors and should only be used in patients with BRAF F mutations, he pointed out. The two drugs inhibit mutant BRAF kinase, which plays a role in the regulation of cell growth. Approximately 50% of patients with melanoma have these mutations.

In the BRIM-3 (A Study of RO5185426 in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma) updated analysis, vemurafenib showed a substantial improvement over dacarbazine with

After years of very few treatment breakthroughs for melanoma (skin lesion, left; cellular depiction, right), prescribers now have four recently approved drugs from which to choose.

a median OS of 13.2 months vs. 9.6 months (HR, 0.37; P<0.001; Lancet Oncol 2014;15:323-332). The BREAK-3 study pitted dabrafenib against dacarbazine ((Lancet 2012;380:358-365). The median progression-free survival (PFS) was roughly double in patients receiving dabrafenib (5.1 vs. 2.7 months; HR, 0.30; P<0.0001). Comparing the two BRAF inhibitors, Dr. Trinh pointed out that in BRIM-3, patients receiving vemurafenib had a median PFS of 5.3 months ((N Engl J Med d 2011;364:25072516). The downside of BRAF inhibitors, she said, is that many of the responses are partial responses and the duration of response is often short.

Trametinib is a mitogen-activated extracellular signal-regulated kinase (MEK) inhibitor. In a Phase III trial, patients given trametinib had a median PFS of 4.8 months compared with 1.5 months in patients receiving chemotherapy (HR, 0.45; P<0.001; N Engl J Med d 2012;367:107-114). The HR for

death was 0.54 ((P=0.01). In an updated analysis presented at the 2013 meeting of the Society for Melanoma Research, in Philadelphia, the median OS in the trametinib-treated group was roughly 15 months ((Pigment Cell Melanoma Res 2013;26:997).

Dr. Trinh explained that BRAF inhibitors cause paradoxical mitogen-activated protein kinase (MAPK) activation in some tissues and should not be used in patients with mutant NRAS or wild-type BRAF melanoma. “This paradoxical activation of the pathway can also explain a unique side effect of BRAF inhibitors, which is patients can develop cutaneous squamoproliferative lesions and other secondary malignancies,” she said. “MEK inhibitors, on the other hand, have no issue with paradoxical MAPK activation.”

Immunotherapy First!

Anthony Jarkowski, PharmD, BCOP, a clinical pharmacy specialist at the

‘For a lot of our patients who present with very bad disease, a poor prognosis, multiple metastases and comorbidities, BRAF inhibitors are probably going to be the first ones you reach for.’

—LeAnn Norris, PharmD, BCOP

Table. Efficacy of BRAF Inhibitors Regimen

Response Rate, %

Median OS, mo

Median PFS, mo

12-Mo OS, %

Ipilimumab 3 mg/kg q3wk × 4

10.1

10.9

2.8

45.6

Vemurafenib 960 mg bid

48.4

13.6

5.3

56

Dacarbazine 1,000 mg/m2

5.4

9.7

1.6

44

Dabrafenib 150 mg bid

50

NR

5.1

NR

bid, twice daily; NR, no response; OS, overall survival; PFS, progression-free survival NEJM. 2011;364:2507-2516; NEJM. 2010;363:711-723; Lancet. 2012;380(9839):358-365.

Courtesy of LeAnn Norris, PharmD

University of Rochester Medical Center, in Rochester, N.Y., who also spoke during the HOPA session, argued that immunotherapy should be used first in patients and BRAF inhibitors should be second in the sequence, as long as patients actually have a BRAF mutation. He maintained that BRAF inhibitors have a short duration of response and only between 1% and 3% of patients have a complete response (CR). “I am a huge believer in immuno-oncology. I think that is where the future is headed,” he said. “A lot of the responses that we see with the BRAF inhibitors are partial responses.”

Dr. Jarkowski pointed out that at around five to six months, patients start to progress on BRAF inhibitors. “The big thing that you have to remember is that about 40% to 50% of patients that progress on BRAF inhibitors die within 28 days of their last dose of the BRAF inhibitor. So, you have a 50-50 shot of making it to another therapy.”

High-dose IL-2 therapy, he said, has shown greater evidence of producing durable CR in the patients who actually respond to the drug, albeit that response rate is fairly low (16%) in a pooled analysis of 270 patients from eight clinical trials ((J Clin Oncoll 1999;17:2105-2116).

Dr. Jarkowski noted that updated data from the previously mentioned ipilimumab trial have shown that this immunotherapy can have longlasting effects. Survival rates at two and three years were 25% in patients who received ipilimumab ((Ann Oncol 2013;24:2694-2698).

In another study, a pooled analysis of three trials, all but one of 15 patients who had a CR to ipilimumab was still alive at 54 to 99-plus months (Clin Cancer Res 2012;18:2039-2047). This same study showed that it took an average of 30 months for patients to achieve a CR. “What you have to remember about immunotherapy is that [it] takes a lot of time to work,” Dr. Jarkowski said.

•

see NAVIGATING, page 32

32 Clinical

Pharmacy Practice News • August 2014

Oncology

ADJUVANT continued from page 1

In 1990, the National Institutes of Health Consensus Conference recommended that patients with stage III colon cancer receive adjuvant chemotherapy, based on evidence of improved survival.

Since then, studies have shown that this practice was not adopted completely. A study by Milburn et al, for example, found that use of adjuvant chemotherapy in stage III colon cancer patients increased from 39% in 1991 to 64% in 2002 ((JAMA 2005;294:2702-2711), thus falling short of the NIH recommendation that all such patients be given the treatment.

In the new study—the largest of its kind to date—investigators identified roughly 200,000 patients who were diagnosed with stage III colon cancer (2000-2011) through the National Cancer Database. Chemotherapy use increased over time: from 59% between 2000 and 2002, to 62% between 2003 and 2006, to 64% between 2007 and 2011, reported Vijaya Bhatt, MBBS, a hematology-oncology fellow at University of Nebraska Medical Center, in Omaha.

Provision of chemotherapy was most influenced by patient age and insurance status (Table), and was lowest for patients with Medicare (52%), followed

by Medicaid (70%), no insurance (73%) and private insurance (77%).

Dr. Bhatt said age alone was not a

NAVIGATING continued from page 31

BRAF Inhibitors LeAnn Norris, PharmD, BCOP, an assistant professor of pharmacy at the South Carolina College of Pharmacy, Charleston, argued during the HOPA session that BRAF inhibitors should be the agent of first choice for patients with melanoma who have a BRAF mutation. She pointed out that the response and survival rates are better with BRAF inhibitors (Table, page 31). Additionally, compared with ipilimumab, BRAF inhibitors are much more tolerable, with fewer adverse drug events and a faster median onset of response (vemurafenib, 1.45 months; dabrafenib, 6.3 weeks) ((N Engl J Med 2011;364:25072516; N Engl J Med 2010;363:711-723).

“If you have a patient who is very sick, perhaps with multiple comorbidities, multiple metastases, etc., and you really want to initiate therapy where they can hopefully get a very quick response, then the [BRAF inhibitors] are the appropriate treatment options,” Dr. Norris said.

When Dr. Norris looks at a patient, she considers whether that individual is going to be able to handle the burdensome side effects of immunothera-

Table. Factors Associated With Adjuvant Chemotherapy For Colon Cancer

Demographics

Patients Receiving Chemotherapy, %

Age, y <60 ≥60

82 55

Gender Male Female

65 60

[CI], 0.53-0.68). Patients were treated with combinations of fluorouracil, leucovorin, capecitabine or oxaliplatin. In an earlier study by Sargent et al ((N Engl J Med 2001;345:1091-1097), adjuvant therapy with fluorouracil plus leucovorin or levamisole reduced mortality by 24% (HR, 0.76; 95% CI, 0.68-0.85), and patients were just as likely to receive benefit from treatment if they were older than 70 than if they were in three other age groups (≤50, 51-60, or 61-70).

An Oncology Pharmacist’s Take

Race/Ethnicity White Black Hispanic

61 65 66

Insurance status Private Uninsured Medicaid Medicare

77 73 70 52

Annual household income, $ <28,000 28,000-49,000 >49,000

59 62 63

valid reason to skip chemotherapy for patients with colorectal cancer. An analysis of four large data sets of patients with stage III disease ((J Clin Oncol 2012;30:2624-2634) showed that adjuvant chemotherapy reduced the risk for death by as much as 40% (hazard ratio [HR], 0.60; 95% confidence interval

py, which include skin/mucosal problems, diarrhea, colitis and hepatoxicity.

She pointed out that 60% of patients experience an adverse drug event with a mean time to resolution of 6.3 weeks ((N Engl J Med 2011;364:2507-2516).

“Sequencing doesn’t really mean anything if we can’t get a patient through the immunotherapy first,” Dr. Norris said. “For a lot of our patients who present with very bad disease, a poor prognosis, multiple metastases and comorbidities, BRAF inhibitors are probably going to be the first ones you reach for.”

She pointed out that MEK inhibitors have low toxicities as well, but a response rate of roughly 22% and a short duration of response ((N Engl J Med 2012;367:107-114).

Dr. Trinh said the two arguments favoring first-line therapy that were presented during the HOPA session were very convincing. “Only a randomized controlled trial that directly compares the different sequences will actually break the tie,” she said, “[so] at this time we can only individualize patient therapy.”

—Kate O’Rourke Drs. Norris, Jarkowski and Trinh reported no relevant financial conflicts of interest.

Caren Lee Hughes, PharmD, BCOP, a clinical pharmacist at MD Anderson Cancer Center, Bay Area, Texas, said she was “surprised” by the low level of adjuvant chemotherapy in the Medicare population, as well as the similarity in the numbers of patients receiving chemotherapy in the uninsured and private insurance populations. This treatment gap is “a huge issue,” Dr. Hughes said.

She pointed out that in the 2005 JAMA study, 53% of the patients had not received a referral to a medical oncologist. If this was a factor in the current study, it would be one that could be acted upon, she said.

“Collection of data to characterize why the older patients did not receive chemotherapy—refusal by the patient, multiple comorbidities, unwillingness to subject geriatric patients to chemotherapy, or lack of access to a medical oncologist— would be useful data to collect in future

studies,” Dr. Hughes emphasized.

When effective patient navigators and/or family support is lacking, she added, cancer treatment can be overwhelmingly complicated, difficult and exhausting. “This data highlights the impact of these factors layered still further on a population that may be difficult to treat due to multiple comorbidities,” she explained. “Practitioners who understand this dynamic may work to find the appropriate supportive mechanisms to better ensure that applicable patients receive the recommended treatment plan.”

Al Benson III, MD, a professor of medicine at Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, said the study was “important” and continues to demonstrate that a standard-of-care treatment is not being administered to a large enough percentage of patients with stage III colon cancer, despite evidence of efficacy. “Treatment guidelines should be followed based on evidence,” he stressed. “Even for patients with comorbidities, guidelines, such as those from the NCCN [National Comprehensive Cancer Network], include treatment approaches for patients who might be considered for less intensive therapy.”

—Kate O’Rourke Drs. Bhatt and Benson reported no relevant financial conflicts of interest.

Antibiotics-Colorectal Cancer Tied Chicago—Certain antibiotics are associated with an increased risk for colorectal cancer, according to the results of a case–control study involving roughly 100,000 patients.

The risk for developing colorectal cancer was increased by 6% in patients first exposed to penicillin more than one year before diagnosis ((P=0.002) and remained statistically significant for patients who used penicillin more than 10 years before a diagnosis of cancer, with an odds ratio (OR) of 1.11.

The risk increased significantly with the number of exposures to penicillin, with ORs ranging from 1.10 for one to five courses, to 1.2 for more than 10 courses ((P<0.0001). The adjusted risk increase associated with each additional antibiotic course per year was 4% on average (P ( =0.008), according to the researchers, who presented the study at the 2014 annual meeting of the American Society of Clinical Oncology (abstract 1599).

“The study suggests that long-term asnd repeated antibiotic exposure might increase colorectal cancer risk,” said investigator Ben Boursi, MD, a medical oncologist from the Integrated Cancer Prevention Center at Tel Aviv Sourasky Medical Center, in Israel.

The investigators speculated that the elevated cancer risk may be due to antibiotics’ tendency to reduce overall bacterial diversity, which can impair the functional stability of microbiota in the colon. “Certain bacteria ... might promote a pro-inflammatory environment,” said co-investigator Yu-Xiao Yang, MD, an assistant professor of medicine and epidemiology at the University of Pennsylvania’s Perelman School of Medicine, Philadelphia. “Others may alter or generate toxins that might potentially be carcinogenic or might transform certain dietary or intestinal content into carcinogenic components.”

Richard Peek, MD, the director of the Division of Gastroenterology at Vanderbilt University Medical Center, Nashville, Tenn., who was not involved with the study, called the research significant, noting that it adds to the growing body of literature supporting the role of the microbiota on diseases that develop within the gastrointestinal tract.

—Kate O’Rourke

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34 Clinical

Pharmacy Practice News • August 2014

Infectious Disease

Mississippi Baby: ‘Functional HIV Cure’ No More HIV rebounded after 27 months without antiretroviral therapy Bethesda, Md.—To pharmacists specializing in HIV, the “Mississippi Baby” serves as a cautionary tale—a reminder that HIV is a wily opponent.

“Although our knowledge of HIV has grown in leaps and bounds, there is still so much that we do not know,” said Jennifer Cocohoba, PharmD, a health sciences associate clinical professor at the School of Pharmacy in the University of California, San Francisco.

Doctors knew all along that there was a chance that HIV could rebound in the so-called Mississippi Baby, a little girl who was thought to be “functionally cured” of infection after receiving an aggressive antiretroviral therapy (ART) shortly after birth ((N Engl J Med 2013;369[19]:1828-1835).

Still, they were sorely disap pointed when the return to viremia occurred—27 months after the child’s ART was discontinued.

The news “felt very much like a punch to the gut,” said the child’s pediatrician Hannah Gay, MD, a pediatric HIV specialist at the University of Mississippi Medical Center in Jackson. Dr. Gay was clearly disappointed not only for the 46-month-old child who will remain on ART for the rest of her life, but also for the HIV community as a whole: researchers, patients and caregivers.

That little girl gave everyone hope that aggressive ART was the key to a cure. “We were hopeful that this would lead to bigger and better things,” Dr. Gay said during a media teleconference.

HIV-infected H9 T cell

The Impact on IMPACT

T

he IMPACT (International Maternal, Pediatric, Adolescent AIDS Clinical Trial) network was gearing up to study whether suspending HIV treatment after a certain period could result in a “functional cure.” Anthony Fauci, MD, head of the National Institute for Allergy and Infectious Diseases, said that no one has been recruited yet for this study, and in light of the rebound infection in the Mississippi Baby, the study would be re-evaluated.

“The study is still in play,” he said, “but we are taking a close look to make sure we do it in an ethically sound way and [still] get answers to important questions.

“We could not detect replication-competent virus in this case, but it was certainly there.”

So, the following questions arise: • How could someone be off therapy for 27 months with no detectable immunologic response to the virus, and yet the virus remained suppressed?

• What was keeping the virus from rebounding?

• Was it a defective virus that eventually found a way to become replication competent?

• What triggered the rebound?

• Where was the virus before rebounding?

In the meantime, Dr. Fauci said, caregivers should follow current HIV treatment guidelines. To “empirically stop treatment and see how things are with the baby” would be unethical, he stressed.

Mississippi Baby History The child had been premature, born at 35 weeks gestation to a mother who was unaware of her HIV status, and therefore, had not received treatment during pregnancy. The mother was diagnosed during delivery through a rapid HIV antibody test. The baby, who was at high risk for infection, was tested almost immediately and had detectable levels of HIV DNA and RNA of just less than 20,000 copies/mL. Because the infant had not received any in utero therapy, Dr. Gay put her on an aggressive regimen of zidovudine (AZT), lamivudine (3TC) and nevirapine, which was initiated at 30 hours old.

(The nevirapine was later switched to lopinavir/ritonavir [Kaletra].) The baby remained on this aggressive ART until 18 months of age, when her caregiver stopped the medication; she was lost to follow-up for more than five months.

When Dr. Gay next saw the child, she was 23 months old and her viral load was undetectable. “Ever since we discovered this case in 2012, we have known that a return to viremia at some point was a possibility, and because this case was unique, we had no way to predict if and when that might occur,” Dr. Gay said. “For that reason, we have been following that child closely about every six to eight weeks in the clinic to monitor for viremia or any clinical signs that could occur.”

During a routine visit in the first week of July, it all changed. “The CD4 was reported as being 28%, which was considerably lower than previous values and that raised our level of concern.

Three days later, we got a copy of her viral load, and it was 16,750 copies/mL,” she explained.

Dr. Gay said there were no other signs of infection: no enlarged lymph nodes, liver or spleen and the child appeared healthy. Subsequent blood work has confirmed Dr. Gay’s fears: The virus had rebounded.

The little girl was given a three-drug ART; the viral load has receded and the CD4 count has gone back up, according to Dr. Gay. The event that triggered the rebound is unknown.

“These [cases] remind us that although we should be hopeful about finding new ways to strengthen the immune system against HIV, at the same time, we should be somewhat conservative about our clinical practices until we have strong evidence to implement these new treatment strategies,” said Dr. Cocohoba, who is not affiliated with the case. “The fact that the viral load became detect-

T cell and virus

Baby Maybe

I

n utero treatment of antiretroviral therapy (ART) has been very effective in preventing neonatal infections. Indeed, when an HIVpositive woman who is pregnant does not receive such a regimen, the rate of neonatal transmission is estimated at 18% to 32%. With effective treatment, in contrast, the risk drops to less than 2% (MMWR 2002;51[RR18]:1-38).

Here are some further considerations in managing maternal and neonatal HIV: • The recommended treatment for an HIV-positive neonate is triple or quadruple ART at diagnosis and continued for life.

• If the mother received ART during pregnancy and the risk for neonatal infection is low, give postexposure zidovudine for about 6 weeks.

• If risk for maternal transmission is high, administer triple ART for up to six weeks.

However, experts point out that the most optimal postexposure prophylaxis in these cases is still unknown.

able in the Mississippi Baby suggests that babies who are infected with HIV need to continue their ART without breaks, as we currently outline in our treatment guidelines.”

Renata O. Smith, PharmD, agreed.

The child’s experience—being removed from ART initially by her caregiver—is also a reminder that pharmacists must educate caregivers about the importance of adherence. “Typically, whenever our patients stop their medications, their viral loads almost immediately increase and CD4 counts decrease,” said Dr. Smith, who is a clinical assistant

•

see HIV BABY, page 36

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36 Clinical

Pharmacy Practice News • August 2014

Infectious Disease

HIV BABY continued from page 34

professor in the Department of Pharmacy Practice at the University of Illinois at Chicago. “Adults have the prerogative to take or not to take ART. These children are dependent on someone administering these medications [to them] in order to stay healthy.”

Pharmacists should encourage pregnant women to be tested for HIV for both the health of the mother and the baby, she added. “As long as we can get

‘Adults have the prerogative to take or not to take ART. These children are dependent on someone administering these medications [to them] in order to stay healthy.’

—Renata O. Smith, PharmD pregnant women to take and adhere to antiretrovirals, we will likely not have babies born positive in the United States,” Dr. Smith said. “As a pharmacist, adherence is one of our biggest roles.

We need to make sure that our patients

understand what they are taking, why they are taking it and how it works, as well as the importance of adherence to ART to improve their health, and in the case of pregnant women to prevent transmission to their babies.”

Although the rebound infection was very disappointing news, Deborah Persaud, MD, a professor of infectious diseases at Johns Hopkins Children’s Center in Baltimore, who consulted on the case, said, “The most important finding is that we know now that this child without a doubt was infected with HIV. There was sufficient time for a reservoir to be established, but the treatment that was given at 30 hours of age dramatically reduced the HIV reservoirs in this child to promote a state of viral remission where the child remained free of replicating virus for up to 27 months off antiretroviral treatment.

“And this time off antiretroviral treatment of 27 months is really unprecedented for perinatal HIV infection.”

—Marie Rosenthal

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Drs. Cocohoba and Smith reported no relevant financial conflicts of interest.

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Clinical 37

Pharmacy Practice News • August 2014

Critical Care

Hyponatremia Linked to Traumatic Falls in Elderly

H

yponatremia puts geriatric patients at increased risk for falling, according to new research from a trauma center in Pennsylvania. The study, presented at the 2014 annual meeting of the Society of Critical Care Medicine (abstract 666), found that lower sodium levels may be more clinically relevant than previously believed.

“For a long time, chronic hyponatremia and mild hyponatremia were thought to be asymptomatic,” said Roy Soiza, MBChB, a clinical senior lecturer at the University of Aberdeen in the United Kingdom, who was not involved with this study. “Over the last five to 10 years, [we have seen] an increasing body of evidence that this isn’t the case.”

Investigators at Lancaster General Hospital in Lancaster, Pa., retrospectively analyzed trauma admissions of patients older than age 65. Of the more than 1,800 patients in this age group who were admitted due to falls between 2008 and 2011, 253 (13.7%) had mild hyponatremia, defined as serum sodium levels less than 135 mEq/L. When compared with non-hyponatremic patients, those with the condition had significantly increased odds of falling (odds ratio, 1.80; 95% confidence interval, 1.26-2.58; P=0.001).

“Hyponatremia, specifically, is important to look at” because it is correlated with increased risk for fracture and other poor outcomes, said Katelyn Rittenhouse, BS, a trauma researcher at Lancaster General Hospital who helped conduct the study.

The prevalence of hyponatremia in healthy community populations, based on literature estimates, is about half of the observed rate of 13.7% among trauma patients with falls, Ms. Rittenhouse said.

Low sodium levels can result in bone demineralization, which is particularly relevant for a population prone to falls, Dr. Soiza noted. Other conditions linked to hyponatremia include attention deficits and an unbalanced gait (Am ( J Med 2006;119:e1-e8).

What remains uncertain, however, is whether hyponatremia plays a role in causing these changes, or whether low serum sodium is a marker of some other health problem. “The little evidence that we have [indicates that] correcting the hyponatremia does result in improvements in cognition and postural instability, for example,” Dr. Soiza said.

If clinicians diagnose a patient with mild hyponatremia, Dr. Soiza cautioned that treatment—including salt tablets or IV saline—should be tailored to the patient’s volemic status, which can have a critical impact on the efficacy of hyponatremia therapies. The administration of IV saline is a viable therapy for hypovolemic hyponatremia, whereas fluid restrictions can treat euvolemic or hypervolemic hyponatremia.

“The critical thing is to establish the correct diagnosis, and this is very challenging in older people,” Dr. Soiza said. The difficulty is due in part to the cognitive impairment associated with hyponatremia, he said, but also to the high prevalence of comorbidities in this patient population. The standard clinical examination for determining the volemic status of older patients, Dr. Soiza added, is likewise unreliable.

WHEN YOU NEED THE POWER OF AN IV ANTIBIOTIC

“We’re missing a trick by not correcting hyponatremia,” he said. “We may be able to prevent falls and fractures by taking hyponatremia more seriously.”

—Ben Guarino Ms. Rittenhouse reported no relevant financial conflicts of interest. Dr. Soiza served on an advisory board to Otsuka Pharmaceutical Co., but received no direct compensation.

NOW APPROVED A WINNING APPROACH IN TREATING ABSSSI* WHEN MOVING BEYOND DAILY IV INFUSIONS TO A ONCE-A-WEEK INFUSION FOR TWO WEEKS Two-dose regimen of 1000 mg followed one week later by 500 mg *Acute bacterial skin and skin structure infections (ABSSSI)1 include cellulitis/erysipelas, wound infection, and major cutaneous abscess and have a lesion size of at least 75 cm2

For more information, visit www.dalvance.com INDICATION DALVANCE™ (dalbavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, and Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus).

IMPORTANT SAFETY INFORMATION Contraindications DALVANCE is contraindicated in patients with known hypersensitivity to dalbavancin.

Warnings and Precautions Serious hypersensitivity (anaphylactic) and skin reactions have been reported with glycopeptide antibacterial agents, including DALVANCE; exercise caution in patients with known hypersensitivity to glycopeptides.

Rapid intravenous infusion of glycopeptide antibacterial agents can cause reactions, including flushing of the upper body, urticaria, pruritus, and rash.

ALT elevations with DALVANCE treatment were reported in clinical trials.

Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including DALVANCE. Evaluate if diarrhea occurs.

Adverse Reactions The most common adverse reactions in patients treated with DALVANCE were nausea (5.5%), headache (4.7%), and diarrhea (4.4%).

Use In Specific Populations In patients with renal impairment whose known creatinine clearance is less than 30 mL/min and who are not receiving regularly scheduled hemodialysis, the recommended two-dose regimen for DALVANCE is 750 mg followed one week later by 375 mg. No dosage adjustment is recommended for patients receiving regularly scheduled hemodialysis, and DALVANCE can be administered without regard to the timing of hemodialysis.

Please see DALVANCE Brief Summary of Full Prescribing Information on the adjacent page.

Reference: 1. Guidance for Industry. Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). October 2013. ©2014 Durata Therapeutics. All rights reserved.

Durata Therapeutics and Dalvance are registered trademarks of Durata Therapeutics Holding C.V. DAL-0073-US May 2014

38 Clinical

Pharmacy Practice News • August 2014

Pharmacogenomics From the ASHP Summer Meeting:

Personalized Medicine Gains Traction Las Vegas—With less costly genotyping techniques, free access to genedrug practice guidelines and the ability to add pharmacogenomics (PGx) to clinical decision software, an increasing number of institutions are taking a tailored approach to patient care that they hope will reduce costs and improve clinical outcomes.

One such institution, Cleveland Clin-

ic, launched the Personalized Medication Program in 2013 to establish an evidence-based system for integrating PGx into its standard medical decisionmaking process. During a session on the discipline at the American Society of Health-System Pharmacists (ASHP) 2014 Summer Meeting, Scott Knoer, MS, PharmD, FASHP, chief pharmacy officer at Cleveland Clinic, detailed the reasons

why his own facility took the PGx plunge.

Dr. Knoer said it was his shared belief with the clinic’s executive leadership that doing so could help identify patients at an increased risk for an adverse drug event or poor response to treatment.

TM

DALVANCE (dalbavancin) for injection, for intravenous use Brief Summary of Full Prescribing Information INDICATIONS AND USAGE: DALVANCE (dalbavancin) for injection is indicated for the treatment

of adult patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureuss (including methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosuss group (including S. anginosus, S. intermedius, S. constellatus). s Usage – To reduce the development of drug-resistant bacteria and maintain the effectiveness of DALVANCE and other antibacterial agents, DALVANCE should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

DOSAGE AND ADMINISTRATION: For treatment of adults with ABSSSI, the recommended

two-dose regimen of DALVANCE is 1000 mg followed one week later by 500 mg. DALVANCE should be administered over 30 minutes by intravenous infusion.

CONTAINDICATIONS: DALVANCE is contraindicated in patients with known hypersensitivity

to dalbavancin. No data are available on cross-reactivity between dalbavancin and other glycopeptides, including vancomycin.

WARNINGS AND PRECAUTIONS: Hypersensitivity Reactions–Serious hypersensitivity

(anaphylactic) and skin reactions have been reported in patients treated with DALVANCE. If an allergic reaction occurs, treatment with DALVANCE should be discontinued. Before using DALVANCE, inquire carefully about previous hypersensitivity reactions to glycopeptides, and due to the possibility of cross-sensitivity, exercise caution in patients with a history of glycopeptide allergy. Infusion-Related Reactions–DALVANCE is to be administered via intravenous infusion, using a total infusion time of 30 minutes to minimize the risk of infusion-related reactions. Rapid intravenous infusions of DALVANCE can cause reactions that resemble “RedMan Syndrome,” including flushing of the upper body, urticaria, pruritus, and/or rash. Stopping or slowing the infusion may result in cessation of these reactions. Hepatic Effects–In Phase 2 and 3 clinical trials, more DALVANCE- than comparator-treated subjects with normal baseline transaminase levels had post-baseline alanine aminotransferase (ALT) elevation greater than 3 times the upper limit of normal (ULN). Overall abnormalities in liver tests (ALT, AST, bilirubin) were reported with similar frequency in the DALVANCE and comparator arms. Clostridium difficile-Associated e Diarrhea –Clostridium difficile-associated diarrhea (CDAD) has been reported in users of nearly all systemic antibacterial agents, including DALVANCE, with severity ranging from mild diarrhea to fatal colitis. Treatment with antibacterial agents can alter the normal flora of the colon, and may permit overgrowth of C. difficile. C. difficilee produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antibacterial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficilee should be discontinued, if possible. Appropriate measures such as fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. Development of Drug-Resistant Bacteria - Prescribing DALVANCE in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

ADVERSE REACTIONS: Because clinical trials are conducted under widely varying conditions,

adverse reaction rates observed in clinical trials of DALVANCE cannot be compared directly to adverse reaction rates from clinical trials of another drug and may not reflect rates observed in practice. Adverse Reactions in Clinical Trials–Adverse reactions were evaluated for 1778 patients treated with DALVANCE and 1224 patients treated with comparator antibacterial agents in a total of seven Phase 2 and Phase 3 clinical trials. A causal relationship between study drug and adverse reactions was not always established. The median age of patients treated with DALVANCE was 47 years, ranging between 16 and 93 years old. Patients treated with DALVANCE were predominantly male (60%) and Caucasian (78%). Serious Adverse Reactions and Adverse Reactions Leading to Discontinuation–Serious adverse reactions occurred in 109/1778 (6.1%) of patients treated with DALVANCE and in 80/1224 (6.5%) of patients treated with comparator. DALVANCE was discontinued due to an adverse reaction in 53/1778 (3%) of patients, and the comparator was discontinued due to an adverse reaction in 35/1224 (2.8%) of patients. Most Common Adverse Reactions–The most common adverse reactions in patients treated with DALVANCE were nausea (5.5%), headache (4.7%), and diarrhea (4.4%).

The median duration of adverse reactions was 4.0 days in both treatment groups.

Table 1. Selected Adverse Reactions in Phase 2/3 Trials Number (%) of Patients Dalbavancin Comparator (N = 1778) (N = 1224) Nausea 98 (5.5) 78 (6.4) Vomiting 50 (2.8) 37 (3) Diarrhea 79 (4.4) 72 (5.9) Headache 83 (4.7) 59 (4.8) Rash 48 (2.7) 30 (2.4) Pruritus 38 (2.1) 41 (3.3) Comparators included linezolid, cefazolin, cephalexin, and vancomycin

Initial U.S. Approval: May 2014 The following selected adverse reactions were reported at a rate of less than 2.0% in these clinical trials: Blood and lymphatic system disorders: anemia, hemorrhagic anemia, leucopenia, neutropenia, thrombocytopenia, petechiae, eosinophilia, thrombocytosis; Gastrointestinal disorders: gastrointestinal hemorrhage, melena, hematochezia, abdominal pain; General disorders and administration site conditions: infusion-related reactions; Hepatobiliary disorders: hepatotoxicity; Immune system disorders: anaphylactoid reaction; Infections and infestations: Clostridium difficilee colitis, oral candidiasis, vulvovaginal mycotic infection; Investigations: hepatic transaminases increased, blood alkaline phosphatase increased, international normalized ratio increased; Metabolism and nutrition disorders: hypoglycemia; Nervous system disorders: dizziness; Respiratory, thoracic and mediastinal disorders: bronchospasm; Skin and subcutaneous tissue disorders: urticaria; Vascular disorders: flushing, phlebitis, wound hemorrhage, spontaneous hematoma.

Alanine Aminotransferase (ALT) Elevations–Among patients with normal baseline ALT levels, more DALVANCE- than comparator-treated patients had post-baseline ALT elevations greater than 3 times the upper limit of normal (ULN), 12 (0.8%) vs. 2 (0.2%), respectively, including three subjects with post-baseline ALT values greater than 10 times ULN. Eight of 12 patients treated with DALVANCE and one comparator patient had underlying conditions which could affect liver enzymes, including chronic viral hepatitis and a history of alcohol abuse. In addition, one DALVANCE-treated subject in a Phase 1 trial had post-baseline ALT elevations greater than 20 times ULN. ALT elevations were reversible in all subjects. No comparator-treated subject with normal baseline transaminases had post-baseline ALT elevation greater than 10 times ULN. DRUG INTERACTIONS: Drug-Laboratory Test Interactions– Drug-laboratory test

interactions have not been reported. Drug-Drug Interactions – No clinical drug-drug interaction studies have been conducted with DALVANCE. There is minimal potential for drug-drug interactions between DALVANCE and cytochrome P450 (CYP450) substrates, inhibitors, or inducers.

USE IN SPECIFIC POPULATIONS: Pregnancy Category C.–There have been no adequate and well-controlled studies with dalbavancin in pregnant women. DALVANCE should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. No evidence of embryo or fetal toxicity was found in the rat or rabbit at a dose of 15 mg/kg/day (1.2 and 0.7 times the human dose on an exposure basis, respectively). Delayed fetal maturation was observed in the rat at a dose of 45 mg/kg/day (3.5 times the human dose on an exposure basis). In a rat prenatal and postnatal development study, increased embryo lethality and increased offspring deaths during the first week post-partum were observed at a dose of 45 mg/kg/day (3.5 times the human dose on an exposure basis). Nursing Mothers– Dalbavancin is excreted in the milk of lactating rats. It is not known whether dalbavancin or its metabolite is excreted in human milk; therefore, caution should be exercised when DALVANCE is administered to a nursing woman. Pediatric Use–Safety and efficacy in pediatric patients have not been established. Geriatric Use–Of the 1778 patients treated with DALVANCE in Phase 2 and 3 clinical trials, 313 patients (17.7%) were 65 years of age or older. The efficacy and tolerability of DALVANCE were similar to comparator regardless of age. The pharmacokinetics of dalbavancin were not significantly altered with age; therefore, no dosage adjustment is necessary based on age alone. DALVANCE is substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in this age group. Renal Impairment–In patients with renal impairment whose known creatinine clearance is <30 mL/min and who are not receiving regularly scheduled renal dialysis, the recommended two-dose regimen for DALVANCE is 750 mg followed one week later by 375 mg. No dosage adjustment is recommended for patients receiving regularly scheduled hemodialysis, and DALVANCE can be administered without regard to the timing of dialysis.

Hepatic Impairment–No dosage adjustment of DALVANCE is recommended for patients with mild hepatic impairment (Child-Pugh Class A). Caution should be exercised when prescribing dalbavancin to patients with moderate or severe hepatic impairment (Child Pugh Class B or C) as no data are available to determine the appropriate dosing in these patients.

OVERDOSAGE: Specific information is not available on the treatment of overdose with DALVANCE, as dose-limiting toxicity has not been observed in clinical studies. In Phase 1 studies, healthy volunteers have been administered single doses of up to 1500 mg, and cumulative doses of up to 4500 mg over a period of up to 8 weeks, with no signs of toxicity nor laboratory results of clinical concern. Treatment of overdose with DALVANCE should consist of observation and general supportive measures. Although no information is available specifically regarding the use of hemodialysis to treat overdose, in a Phase 1 study in patients with renal impairment less than 6% of the recommended dalbavancin dose was removed.

Manufactured for: Durata Therapeutics U.S. Limited Chicago, IL 60606 US Patent Numbers: Available online at http://www.duratatherapeutics.com/products/product-patents DALVANCETM is a trademark of Durata Therapeutics Holding C.V. Please also see Full Prescribing Information at www.dalvance.com.

DAL-0067-US

Figure. Cost per genome.

Avoiding such outcomes, he said, could address cost concerns that exist not only at the clinic but also nationwide.

“The program was established because the cost of heath care in the U.S. is high and unsustainable, yet clinical outcomes are often lower compared with other countries,” Dr. Knoer explained.

His overall approach in getting the PGx program off the ground was to dedicate multiple pharmacy resources to its development, including adding tweaks to the Clinical Decision Support (CDS) component of the clinic’s electronic health records. Providing educational programs focused on PGx was another important component to the initiative, he noted.

Strength in Numbers Dr. Knoer said his collaboration with physicians from the clinic’s Drug Information Center and Pharmacy Informatics Department was crucial to the effort’s success. However, it soon became evident that applying PGx clinically was a full-time job and that pharmacy thus needed an expert to coordinate efforts across the enterprise and to address questions from physicians.

So with support of the system’s CEO, in 2013, the clinic hired Kevin Hicks, PharmD, PhD, a PGx clinical specialist.

One of Dr. Hicks’ key roles has been educating patients, clinicians and trainees about the benefits of the genomics discipline. He also has been responsible for identifying specific gene–drug pairs that have to be factored into treatment decisions. Dr. Hicks also created CDS software-based PGx tools that guide testing and treatment recommendations at the point of care.

These various interventional strategies currently are used “to identify patients who are at an increased risk for a [genotype leading to a poor outcome] and to modify their drug therapy to optimize response,” Dr. Hicks said. “Eventually we would like to expand our program to include prospective genotyping for those who are likely to be prescribed a drug influenced by [a genotype]. We are currently [planning] a pilot study to determine the feasibly and cost-effectiveness of [that approach].”

Clinical 39

Pharmacy Practice News • August 2014

Pharmacogenomics The challenge of implementing a clinical PGx program in a cost-effect manner is one that almost all institutions have to face, Dr. Hicks noted. Although genotyping costs are decreasing (Figure) and the tests are relatively inexpensive compared with many other clinical assays, he pointed out that reimbursement for the genetic assays is limited.

To address this challenge, Cleveland Clinic initially targeted gene–drug pairs that are only eligible for reimbursement, such as HLA-B*57:01–abacavir and TPMT–thiopurines.

Of course, cost was not the only consideration in setting the initial list of gene–drug pairs; clinical relevance was also factored into the equation. In the abacavir gene–drug pairing, for example, carriers of the HLA-B*57:01 genotype have a significantly increased risk for developing hypersensitivity to the anti-HIV medication; thus, the drug is not recommended in treatment guidelines published by the Clinical Pharmacogenetics Implementation Consortium (CPIC; Clin Pharmacol Ther 2012;91:734-738).

A Consortium of Experts The Cleveland Clinic is not the only hospital to design its PGx interventions based at least in part on the work of the CPIC. This research and advocacy consortium has had a major impact on many other PGx early innovators, according to Kelly E. Caudle, PharmD, PhD, BCPS, the CPIC coordinator at St. Jude Children’s Research Hospital, in Memphis, Tenn., who discussed the initiative during the ASHP session. With more than 130 members from 62 institutions in 14 countries, the CPIC came together in 2009 and has since published 13 standard format guidelines that are free and available online (www.pharmgkb.org), Dr. Caudle noted. By using these invaluable resources, she added, hospitals don’t have to struggle with the difficult task of crafting their own PGx guidelines and applying them across multiple facilities and practice sites.

Each guideline includes background information about the gene–drug pair and a standard system for grading levels of evidence linking the pair to an inadequate response to drug therapy, Dr. Caudle explained. The guidelines also include a standard system for assigning strength to each prescribing recommendation that is made—determinations that are based on several factors, including the level of evidence for potential harm to the patient if the recommendations are not followed.

The guidelines are updated regularly, further adding to their usefulness.

Just last month, for example, the CPIC published an update on the affects of the SLCO1B1 genotype on simvastatin (Clin Pharmacol Ther doi: 10.11038/ clpt.2014.125). The genotype “increases

systemic exposure to simvastatin and [boosts] the risk of muscle toxicity,” the authors reported. They go on to cite evidence for the interaction in the literature and list therapeutic recommendations for managing this potential adverse effect.

However, CPIC guidelines are designed to help clinicians understand how available genetic test results should be used to optimize drug therapy—not whether the tests should be ordered in the first place, Dr. Caudle stressed. “For example, if you [already] knew your patient’s diplotype was CYP2D6*4/*4,

the guidelines provide you with the information to translate it into a phenotype, such as ‘CYP2D6 poor metabolizer,’ and then into a recommendation, such as ‘avoid codeine use due to lack of efficacy.’” But if a system isn’t created to encourage PGx testing in the first place, no amount of clinical guidelines on what to do with the results of such testing will help protect patients against poor responses to treatment, she stressed.

To that end, St. Jude is broadening the scope of its PGx program. When it first began in 2005, only two genes were

being tested, and that was done only in a selected patient population, according to Kristine Crews, PharmD, BCPS, translational research laboratory director, Pharmaceutical Sciences Department at St. Jude. The institution has since expanded its efforts and is now preemptively testing all new patients for five genes.

Dr. Crews stressed that the clinical benefits of embracing personalized medicine are clear. “We are not only seeing a decrease in side effects but are also getting to the right dosing much

•

see PERSONALIZED MEDICINE, page 40

THE TRUTH HURTS

The truth behind EXPAREL

®

(bupivacaine liposome injectable suspension)

Promotional claims position EXPAREL® as the only single-dose local analgesic to reduce or eliminate opioids with pain control for up to three days with no need for catheters or pumps.1-2 Sound too good to be true? It is.

FICTION: FACT:

FICTION: FACT:

EXPAREL® provides patient-focused pain control for up to 72 hours.3 Based on further analysis of the data,6 between 12–72 hours there was minimal to no difference in mean pain intensity between EXPAREL® and saline (placebo).4-5 The only single-dose local analgesic to reduce or eliminate opioids with pain control for up to three days.3 The clinical benefit of the attendant decrease in opioid consumption was not demonstrated.2-3 Saline therapy (placebo) was favored between 12–72 hours.5

Get the facts and download studies about EXPAREL® at factvsfiction.info/ppn or call 1-800-448-3569 for more information.

Every day without

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1 What is EXPAREL®, EXPAREL® Website. www.exparel.com/what-is-exparel.shtml. Created May 2, 2008. Updated December 16, 2013. Accessed February 4, 2014. 2 Exparel® [prescribing information]. Parsippany, NJ: Pacira Pharmaceuticals, Inc.; 2011. 3 EXPAREL. Advertisement. Outpatient Surgery1 Nov. 2013:57-58. Print. 4 Golf M, Daniels SE, Onel E. A Phase III, randomized, placebo-controlled trial of DepoFoam® bupivacaine (extended-release bupivacaine local analgesic) in bunionectomy. Adv Ther. Sep 2011;28(9):776-788.

5 Gorfine SR, Onel E, Patou G, et al. Bupivacaine Extended-Release Liposome Injection for Prolonged Postsurgical Analgesia in Patients Undergoing Hemorrhoidectomy: A Multicenter, Randomized, Double-blind, Placebo-controlled trial. Dis Colon Rectum. Dec. 2011;54(12):1552-1559. 6 Data on File.

There are inherent risks in all medical devices. Please refer to the product labeling for Indications, Cautions, Warnings and Contraindications. Failure to follow the product labeling could directly impact patient safety. Physician is responsible for prescribing and administering medications per instructions provided by the drug manufacturer. Refer to www.iflo.com for product safety Technical Bulletins.

EXPAREL® is a registered trademark of Pacira Pharmaceuticals Inc. I-Flow*, LLC, A Kimberly-Clark Health Care Company. ON-Q* Pain Relief System *Registered trademark or trademark of Kimberly-Clark Worldwide Inc. © 2014 KCWW All rights reserved. RX Only. MK-00640 2/2014.

40 Clinical

Pharmacy Practice News • August 2014

Pain Medicine

Facing Opioid-Induced Constipation Knowledge Gap A

bout half of physicians who prescribe opioids for long-term use do not take steps to ensure that their patients are getting adequate prophylaxis for a common, debilitating side effect of the pain medication—opioid-induced constipation (OIC), a new study suggests.

Fortunately, pharmacists in at least one health system are stepping up to the challenge by enacting a prophylactic bowel regimen in the palliative care unit.

Such efforts are sorely needed, given the prevalence of OIC. “Constipation is a top side effect” of opioid use, according to study author Sharon Hwang, MD, MPH, the medical director of CE Outcomes, a health care research firm in Birmingham, Ala. “Among surveyed clinicians, there was a lot of varied understanding of OIC,” she noted, specifically citing differences in knowledge of the condition among nurse practitioners (NPs), primary care physicians and pain specialists.

With support from Takeda Pharmaceuticals—a co-marketer of lubiprostone (Amitiza), an oral medication that was approved for OIC in April 2013—Dr. Hwang posed a series of questions to clinicians to ascertain their perceptions of OIC. Based on responses of more than 300 health care professionals, Dr. Hwang and her colleagues observed “many gaps in the care of patients with chronic pain and OIC.” For example, they found that only half of primary care physicians and pain specialists regularly prescribe a prophylaxis regimen for opioid users. Alternatively, about three-fourths of NPs prescribe prophylactic medication to long-term opioid users more than 40% of the time.

Dr. Hwang noted that some survey respondents had not considered OIC as a side effect of treatment with opioids.

She believes that nurse practitioners, by virtue of the increased time they

spend with patients, are the most likely to recognize OIC and prescribe prophylactics accordingly.

“You have to ask the right question” to determine if patients are suffering from OIC, Dr. Hwang said—and not all clinicians take that step.

“The first step is making everyone aware this is a big issue,” said Gyanprakash Ketwaroo, MD, a gastroenterologist at Beth Israel Deaconess Medical Center, in Boston. “There are multiple approaches, but no real comparison studies yet.”

The Pharmacist’s Role One approach to managing OIC is underway at Abington Memorial Hospital, near Philadelphia, where Maria Foy, PharmD, a clinical specialist in pain management, has enacted a prophylactic bowel regimen in the palliative care unit.

Over two year-long trials, from November 2011 to February 2012 and April 2012 to March 2013, clinicians carried out the regimen, aimed at reducing the effects of OIC. In the first year of the trial, 29 palliative care patients were eligible for the initiative; of these, 25 (86%) had bowel movements within 72 hours after treatment (PAINWeek 2013; abstract 33).

The second trial demonstrated similar results, with 24 of 31 patients achieving laxation within 72 hours.

Once a regimen is recommended, clinicians at Abington Memorial rely on several techniques for treating OIC. A typical regimen begins with the use of a stimulant and stool softener combination. Depending on the patient, Dr. Foy said, she might titrate up to nine tablets of senna per day—three tablets, three times daily.

“Most people wouldn’t think of going that high,” Dr. Foy said, but she maintains that it is a safe and effective way to manage constipation.

( <0.001). The same study revealed (P that clinicians prescribed laxatives to significantly more patients with OIC than non-OIC patients (8.8% vs. 0.8%, respectively; P<0.001).

The Pharmerit and Takeda researchers also found that the incidence of OIC among chronic opioid users without cancer ranges from 2.9% in nonelderly patients to 6.6% in elderly patients, and up to 15% in long-term care patients without cancer.

Eye-Opening Findings If laxatives are insufficient, next steps include tap water enemas and suppositories. After 72 to 96 hours of constipation and failure of rectal treatments, clinicians may administer methylnaltrexone (Relistor, Salix).

For example, when she encounters a patient who hasn’t had a bowel movement in about 10 days, Dr. Foy said, “I will use Relistor right off the bat.”

Although effective, methylnaltrexone is a restricted-use drug at Abington Memorial because of its cost. The average price for a single-use vial of the drug is $48, and a seven-dose kit is $336 ((Am Fam Physician 2010;82:678-681).

The high cost of laxatives isn’t the only way that OIC can put a squeeze on budgets. Based on a retrospective review of Medicare and commercial claims data from more than 16,000 chronic opioid users, researchers at Pharmerit International in Bethesda, Md., and Takeda found that patients who developed OIC had higher than average health care costs compared with patients without constipation.

The average annual cost of health care (including inpatient and outpatient care) for a nonelderly patient with OIC was more than $23,000, significantly higher than the $13,000 average annual cost for a patient without OIC

Dr. Ketwaroo described the prevalence of OIC as “somewhat eye-opening.” Clinicians should try to do more, he said, to increase awareness about OIC. As a gastroenterology fellow, he receives a “fair amount” of tertiary care referrals for OIC, but practitioners in community care may not be as cognizant of the side effect, he said.

“Everything has its own side effects,” Dr. Ketwaroo said. “Can we minimize the number of opioids we are prescribing? I think that’s a fair question to ask.”

Half of the clinicians who spoke with Dr. Hwang voiced concern that constipation or sedation, as side effects of treatment with opioids, would result in poor adherence or discontinuation of the drugs for long-term pain management.

“If we can control constipation in clinical opioid use,” Dr. Hwang said, “we can optimize patient adherence.”

The results of Dr. Hwang’s surveys were presented at the 2013 PAINWeek meeting (abstract 54), as were the results of Dr. Foy’s OIC interventions (abstract 133).

—Ben Guarino Drs. Ketwaroo and Foy reported no relevant financial conflicts of interest. Dr. Hwang, as an employee of CE Outcomes, received support from Takeda Pharmaceuticals.

Pharmacogenomics

PERSONALIZED MEDICINE continued from page 39

quicker,” Dr. Crews told Pharmacy Practice News. “I think using pharmacogenomics testing will become the standard of care across multiple types of practice settings and will be essential to achieve the best outcomes in personalized care. I also think that pharmacists have the right skills to be able to lead these initiatives in the hospital setting.”

Kaiser Permanente’s Approach Because of its robust clinical pharmacy services and its position as an integrated health system with an embedded health information technology (HIT) infrastructure, Kaiser Permanente Colorado, in Denver, is an ideal environment to adopt PGx testing, according

to ASHP session presenter Samuel Johnson, PharmD, FCCP, BCPS, a clinical pharmacy specialist, applied pharmacogenomics at Kaiser Permanente.

“We are leveraging existing [HIT] resources to develop [CDS] tools to facilitate evidence-based pharmacogenetic recommendations at the point of care,” Dr. Johnson said. He stressed, however, that “an undertaking of this sort is not without challenges—one being the need to convince ... administrators that implementation has a return on investment, given numerous financial pressures and demands put on the health system.”

Several ongoing clinical trials will hopefully soon show whether preemptive PGx testing affects outcomes in clinical practice. Some include the PGen4Kids study at St. Jude’s Research Hospital, the PREDICT (Pharmacogenomic Resource for Enhanced Decisions

in Care and Treatment) study at Vanderbilt University Medical Center, Nashville, Tenn., and the 1200 Patients Project at the University of Chicago.

Until positive data from those trials are available, reimbursement for PGx testing may continue to be a challenge, Dr. Johnson noted. And that could understandably “limit clinical implementation [of PGx] for some health systems,” he said. “However, the main takeaway should be that use of a cost-effective test platform, coupled with [CDS] that ensures proper use of pharmacogenomic information, will more than pay for the cost of testing over the long-term.”

—Paul Bufano None of the sources reported any relevant financial conflicts of interest.

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42 Clinical

Pharmacy Practice News • August 2014

Patient Safety

New Standards Help Prevent Deadly Tubing Misconnections Las Vegas—The universal design of many small-bore connectors such as luer locks allows for the chance of devices with distinct functions to be attached, and although the resulting misconnections are rare, they can be fatal, according to a late-breaking session held during the American Society of Health-System Pharmacists (ASHP) Summer Meeting.

To prevent these errors, new international design standards for medical tubing connectors will be released over the next several years as part of an International Organization for Standardization (ISO) initiative, Peggi Guenter, PhD, RN, the senior director for clinical practice, quality, and advocacy at the American Society for Parenteral and Enteral Nutrition, in Silver Spring, Md., said during the ASHP meeting. Starting with enteral devices this year, she noted, the campaign gradually will introduce new standard connectors for specific delivery systems, including neuraxial applications in 2015, and respiratory and driving gases at a date yet to be determined.

The campaign to increase standardization is important because there can be about five systems of therapy using similar luer connectors in a very small area, which can increase the risk for a misconnection, Dr. Guenter pointed out.

The safety problems that can result

‘Even though awareness has greatly increased, this is still an ongoing problem because it involves a very complex system that requires an organized effort to change.’

—Peggi Guenter, PhD, RN from this mixed bag of connector types have been well documented in the patient safety literature. Dr. Guenter coauthored a study that described 24 incidents in which an enteral feeding formula, other solution or medication intended for a feeding tube was accidentally administered through the wrong route—mainly intravenously (Jt ( Comm J Qual Patient Saff 2008;34:285-292).

Of those reported cases, eight (33%) resulted in a permanent injury, a lifethreatening situation and/or death.

“Some factors that contribute to device misconnections include compatible tubing between unlike systems, the use of intravenous syringes for oral medications and universal spikes for bags,” Dr. Guenter said. “There are also some human factors that contribute to misconnections, [such as] nurses who work up to 16-hour shifts [and who] can be very busy with patient responsibilities. Because they can be distracted, there can be an automatic slip where they’re thinking about something else when a mistake happens.”

To address the problem, the Joint Commission issued a Sentinel Event Alert about tubing misconnections in 2006 (bit. ly/1vnT6l4). Some of the reported cases of misconnected tubing involved central IV catheters, peripheral IV catheters, nasogastric feeding tubes, percutaneous enteric feeding tubes, peritoneal dialysis catheters, tracheostomy cuff inflation tubes and automatic blood pressure cuff insufflation tubes. The organization consequently called for manufacturers to implement design features in the form of either forcing functions or a physical barrier that would make it difficult, if not impossible, for unrelated delivery systems to be connected.

Data Eventually Prompt Action The ISO initiative began about two years after the Joint Commission alert was released, when the organization decided that a change in connector standards was needed, and developed the small-bore master standard ISO 80369-1. The standard, which has since been adopted globally, established requirements for small-

bore connectors for both liquids and gases. It also required connectors to be either rigid or semi-rigid, and that they be not connectable with luer or needless connector ports. The campaign is gaining exposure through “StayConnected2014,” an industry-driven communication push to help transition the change (www.stayconnected2014.org).

“Even though awareness has greatly increased, this is still an ongoing problem because it involves a very complex system that requires an organized effort to change,” Dr. Guenter said. “No single manufacturer makes the entire system; some make tubes, some make bags and some make syringes, so a high level of coordination is crucial. However, with more institutions following these preventative measures within the next few years, I’m confident that there will be fewer mistakes and lives will ultimately be saved.”

—Paul Bufano Dr. Guenter reported no relevant financial conflicts of interest.

Critical Care

FLUID OVERLOAD continued from page 1

U.S. health care and pharmacy dispensing. The retrospective cohort study was designed to improve understanding of the potential benefits of conservative fluid management, such as small-volume, maximally concentrated IV solutions delivered via a syringe pump, in contrast to current medication modes of delivery.

The study was carried out using information from the Premier Healthcare Solutions (a large group purchasing organization) research database. Subjects consisted of adult patients with a hospitalization that included time in an ICU, central line placement, the administration of an IV loop diuretic and at least two medications from a list of commonly used continuous infusions for at least 50% of ICU days.

The database generated 63,974 directly matched patients in each of the fluid overload and comparison cohorts. The fluid overload cohort had an average of 56.7% higher overall hospital costs per visit ($42,368 vs. $27,042), 92.7% higher ICU costs ($10,902 vs. $5,659), and correspondingly longer hospital (11.5 vs. eight days) and ICU LOS (6.2 vs. 3.6 days).

These patients also had higher rates of mortality (20% vs. 16.8%) and 30-day readmission (21.82% vs. 21.28%) than the comparison group.

The researchers also reviewed a subset of common continuous vasopressor medications used in the study, and compared the daily fluid savings from the maximal concentration as opposed to a commonly used standard concentration for patients of average weight and dosage. Fluid savings varied from 460 mL (nitroprusside) to as much as 8,294 mL (epinephrine) per day for the medications reviewed, and patients were required to have at least two of the study medications during their ICU stay.

Contributing Factors The results underscore the fact that medication administration can contribute significantly to a patient’s daily fluid intake, according to primary study author Debbi Child, PharmD, BCPS, a clinical resource specialist at Smiths Medical. Dr. Child also pointed to practice patterns that may contribute to fluid overload. “While medication delivery models vary between institutions, it’s common that continuous medications for U.S. adult ICUs are provided in pre-

mixed dilute formulations,” she said.

“Physicians typically order the drug and dosage, but cannot specify the concentration ... that is predetermined by the pharmacy. While the drug fluid volume is documented in the patient’s chart by nursing, this intake is not easily controlled by physicians and can add to a patient’s daily fluid intake.”

When thinking about measures to prevent fluid overload, it’s important to remember that fluid is a drug with a therapeutic window, and that dosing rates should be individualized to the goals of therapy, the clinical scenario and the severity of illness, noted David Askenazi, MD, the director of the Pediatric and Infant Center for Acute Nephrology, Children’s of Alabama/University of Alabama at Birmingham. “It’s generally recognized that fluid resuscitation improves outcomes early in [patients with] shock,” said Dr. Askenazi, who was not involved in the Smiths Medical study. However, once the patient moves beyond that acute phase, caregivers need to keep in mind that “how we prescribe fluid can have a direct impact on excess fluid accumulation.” One way to keep that accumulation in check, he noted, is to concentrate medications and mini-

mize IV fluids based on nutrition goals.

It’s also important for physicians to “trend the patient’s cumulative percent fluid balance,” Dr. Askenazi said. “This critical vital sign can quantitate the degree of fluid overload at one time point, and perhaps more importantly, provide insights to where the patient is heading.”

Increasing Awareness The knowledge gained from the current study has helped define the burden of illness and the patient population most at risk (cardiac) from fluid overload, Dr. Child pointed out. Although further research is needed, she noted, the study could yield an immediate benefit—that is, increased awareness of the syndrome. If physicians become more proactive about fluid overload as a result, that change “holds promise to decrease length of stay and costs, and improve patient outcomes.”

—Paul Bufano Dr. Child is a full-time employee of Smiths Medical, which manufactures the Medfusion syringe pump. Her co-authors are employees of Premier Healthcare Solutions and received funding from Smiths Medical for this study. Dr. Askenazi is on the speaker’s bureau of Baxter/Gambro Renal.

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44 Technology

Pharmacy Practice News • August 2014

Informatics

New Pharmacy App To Document Outpatient Interventions Las Vegas—The American Society of Health-System Pharmacists (ASHP) is releasing the Pharmacy Ambulatory Care Tracker (PACT) app and reporting dashboard that ambulatory care pharmacists can use to document interventions and demonstrate their affect on patient care in a way previously not possible, according to the system’s developers.

The app can be used on any iOS device, which is where the data are entered at the

toward provider status, it is more important than ever for them to be able to capture interventions in the outpatient setting in an efficient manner, Mr. Bruggeman noted.

“We needed a [system] more sophisticated than using

point of care. “The value [off the technology], however, comes through its accompanying website, where all of the reported information is sent and stored using a cloud-based database,” said Jack Bruggeman, the director of Acquisitions and Special Publishing at ASHP. As pharmacists move

Cases in Hyponatremia: Minimizing Risks, Optimizing Outcomes To participate in this FREE CME activity, log on to

www.CMEZone.com Release Date: August 25, 2014

Expiration Date: August 25, 2015

Faculty

Goal

Juan Carlos Ayus, MD

The goal of this educational activity is to provide clinicians with clinically relevant information and practice strategies concerning the assessment and management of hyponatremia.

Professor of Medicine Division of Nephrology University of Texas Health Science Center San Antonio, Texas

Michael L. Moritz, MD Associate Professor, Pediatrics Clinical Director, Pediatric Nephrology Medical Director, Pediatric Dialysis Children’s Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania

Denise H. Rhoney, PharmD Associate Professor Eshelman School of Pharmacy University of North Carolina at Chapel Hill Chapel Hill, North Carolina

Learning Objectives At the completion of this activity, participants will be better prepared to: 1 Distinguish the various subtypes of hyponatremia.

2 Describe the comorbidities and causes commonly associated with hyponatremia and their significance in treatment strategy.

3 Summarize current evidence and best practices in the management of hyponatremia.

4 Explain how to mitigate adverse events secondary to treatment of hyponatremia.

5 Apply strategies to improve the management of hospitalized patients with hyponatremia.

Intended Audience The intended audience for this educational activity includes physicians (cardiologists, critical care specialists, endocrinologists, hepatologists, hospitalists, intensivists, and nephrologists), nurses, pharmacists, and other clinicians who care for individuals with hyponatremia.

Accreditation Statement This activity has been planned and implemented in accordance with the Essential Areas and policies

This activity is jointly sponsored by Global Education Group and Applied Clinical Education.

of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Global Education Group and Applied Clinical Education. Global Education Group is accredited by the ACCME to provide continuing medical education for physicians.

Credit Designation Global Education Group designates this activity for a maximum of 1.0 AMA PRA Category 1 Credit™.

Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Pharmacist Continuing Education Accreditation Statement Global Education Group is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

Credit Designation Global Education Group designates this continuing education activity for 1.0 contact hour(s) (0.10 CEUs) of the Accreditation Council for Pharmacy Education. (Universal Activity Number - 0530-9999-14-061-H01-P) This is a knowledge-based activity

Accreditor Contact Information For information about the accreditation of this program, please contact Global Education Group at (303) 395-1782 or inquire@globaleducationgroup.com.

Supported by an educational grant from Otsuka.

Distributed via CMEZone

paper forms that would allow pharmacists to capture a high level of details without much effort,” he said.

Mr. Bruggeman added that he hopes the PACT app and reporting dashboard “will help executive leadership [appreciate] the need for more pharmacists in the ambulatory setting, and that it will even have a positive effect on clinical outcomes.” For example, “if an institution sees that it [is treating] a significant number of patients with hypertension, it can then figure out what can be done differently to manage them better,” he explained.

The system works like this: a health system or other care site creates an account to access the PACT website, pharmacists download the free mobile app and connect with the facility. They then log their encounters and the institution can enter the website to view core metrics tracked in real time.

‘For the first time ambulatory care pharmacists won’t have to try to adapt an illsuited system to their needs.’

—Robin Coleman The website will supply users with 12 built-in metrics that can be downloaded into an Excel spreadsheet. Yearly subscriptions to access the website start at $499 for one to five users and increase from there. ASHP is planning to make the product available to the general public by December. An Android version is also planned.

A First of Its Kind Robin Coleman, acquisitions editor at ASHP, stressed the ground-breaking nature of the PACT app. “To my knowledge, this is the first mobile app developed to allow ambulatory care pharmacists to document interventions,” he said. “It was recognized that a mobile app could offer a streamlined method of documentation that would provide quantifiable data, which are difficult to glean from the text entered into a patient’s health records.”

Although Mr. Coleman acknowledged that “other vendors of EHR systems or software packages use clouddatabases to some degree, the strength of the PACT system is that it is tailored for this specific purpose. So for the first time ambulatory care pharmacists won’t have to try to adapt an ill-suited system to their needs.”

—Paul Bufano

Technology 45

Pharmacy Practice News • August 2014

Practice Pearl

Improving Safety in Electronic Prescribing of Chemotherapy Mary Mably, RPh, BCOP Pharmacy Oncology Coordinator University of Wisconsin Hospital and Clinics Madison, Wisconsin

E

lectronic prescribing of chemotherapy has transformed the way that physicians order these potentially lifesaving drug regimens, but pharmacists need to be vigilant for “video-game” prescribing and other signs of an overreliance on the technology that could lead to medication errors.

Electronic prescribing offers many safety advantages over the paper prescription pad. However, as we gain more experience with this technology, we have become aware of new and different safety issues than were seen with hand-written prescriptions. It is vital for each oncology practice or institution involved in chemotherapy management to identify and implement practices that account for these safety issues and protect patients from harm.

The rate of chemotherapy errors reported in the literature ranges from 3% to 19%.1 Fortunately, catastrophic chemotherapy errors are rare and usually consist of overdoses or incorrect route of administration of medications.

Other errors, although not as devastating, may still impose a large burden on the cancer patient, who frequently has limited tolerance for drug toxicities. These include ordering errors, such as missing or incorrect supportive care medications; inadequate hydration; and failure to appropriately adjust chemotherapy doses. Misleading system designs, inadequate training, and process mismatches also can cause unanticipated problems.2 Another unintended consequence of using electronic systems to prescribe chemotherapy may be the challenge of training new hematology-oncology physicians to write chemotherapy orders.

New hem/onc physicians may never have hand-written an order for chemotherapy.

It may be challenging for them to learn and to recall correct and appropriate chemotherapy doses, hydration, antiemetics, and other supportive care when all of the necessary elements are already included in pre-formulated chemotherapy order sets. Therefore, it might be more difficult for them to recognize errors that may exist in electronic order sets.

It also is important to teach new oncology pharmacists how to systematically and completely check and verify physicians’ chemotherapy orders. At the University of Wisconsin Hospital and Clinics, we use a pre-formulated Chemotherapy Review Progress Note that prompts the pharmacist to check the orders using a

systematic approach (Figure 1).

Some of the significant safety advantages in prescribing chemotherapy using an electronic system and computerized physician order entry are shown in the Table.

Care Transitions and Other Trouble Spots Medication errors and other mishaps also can occur in transitional areas of

care. Pharmacists can help prevent or at least mitigate these errors by accessing patients’ electronic health records (EHRs) in a way that promotes improved communication among care settings and providers. Chemotherapy and supportive care received by the cancer patient can be a good place to start such quality improvement efforts.

Prescriber buy-in and workarounds, unapproved modifications to reviewed

electronic “builds,” and a false sense of security from pre-made builds are other trouble spots to keep in mind.3 This false sense of security in the software may produce behavior that I call “videogame” prescribing. This is the feeling that the computerized program must be “right,” even though the software might not consider individual patient characteristics. In such a scenario, the

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46 Technology

Pharmacy Practice News • August 2014

Practice Pearl

IMPROVING SAFETY

Table. Safety Advantages in Electronic Prescribing Of Chemotherapy3

continued from page 45

prescriber then proceeds to push buttons (or clicks) until the task is complete or he or she has “won” the game.

That is why the electronic build of chemotherapy medication records should be carefully considered. “Buttons” to prompt correct dosing may be included in the build, such as dosing units and routes of administration. Not allowing more than one dosing unit per medication record or not allowing incorrect routes of administration may increase prescribing safety. For example, intrathecal administration would never be allowed for a vinca alkaloid, and prescribers may not be allowed to order a drug in both mg/kg and mg/m2 units.

The dose rounding for various drugs that is forced by an EHR also should be closely monitored. Dosing of medications out to a decimal place that does not allow accurate measurement during preparation should never be allowed, as it may cause errors in preparation. Dose rounding may especially be an issue in the treatment of pediatric patients, and may require separate electronic records to be built for adults and children. Dose caps for specific medications should be considered, as either a hard stop (requiring action) or a soft stop (suggesting action) to promote safety with chemotherapy.

Sources of error that should be carefully considered and monitored include incorrect data entry, error in electronic build, poor data organization, data omissions, workflows occurring outside the electronic build, and confusing presentation of chemotherapy treatment plan options leading to the choice of an incorrect chemotherapy treatment plan.2 The realization that these errors may exist despite the most carefully devised safety systems may prevent devastating errors from reaching the patient. Multidisciplinary review of new electronic order sets including, at a minimum, physician, pharmacy, nursing, and others as necessary, may maximize the chances of catching any build errors.

Standardizing Order Sets Can Help Standardization of chemotherapy ordering using electronic prescribing offers yet another opportunity to improve safety.4 In the past, paper order sets also provided standardization of ordering, but were difficult to update, maintain, and sometimes access. Best

Standardization of protocol prescribing Increased legibility Automatic dose calculation Availability of electronic decision support Increased completeness of orders Accessibility of chemotherapy orders from other locations Reduction in prescribing errors

Figure 1. Pharmacist h i chemotherapy h h review i progress note.

Figure 2. Treatment plan l information i f i section i off electronic l i chemotherapy plans. practices in chemotherapy prescribing include standardizing the presentation of the treatment plan summary with drug, dose, days of therapy, cycle length, and course duration (Figure 2).

Reference citations for the treatment also should be included as a standard part of the electronic prescribing and may include a hyperlink to the actual reference. Additionally, standardization offers the advantages of ensuring that needed supportive care (growth factors, antiemetics, and hydration) are prescribed similarly across the practice and not overlooked. Besides increased safety with the use of standardization, drug-cost savings often may be achieved with the use of standardized antiemetics and other supportive care, reducing unnecessary expenditures.

Standardization can be used to ensure a patient’s informed consent, which can be built into the system as an electronic prompt in the treatment plan. Follow-up laboratory tests and appointments may be standardized as well, in an effort to minimize inadvertent omission of any of these important components of patient care.

The computerized or electronic prescribing of chemotherapy offers other opportunities to improve patient care.

The process to obtain and analyze data is made more feasible and accessible by the EHR. Discrete data points available through electronic prescribing may be used to provide impetus and evidence to improve quality and safety of chemotherapy prescribing.5 Pharmacists and others involved in the care of patients with can-

cer can use the data in quality improvement projects to improve the prescribing of chemotherapy at their practices.

In conclusion, although electronic prescribing of chemotherapy offers significant advantages in safety, it is not an alternative to the knowledge and vigilance of the various health care professionals who check and verify the electronic orders. However, the automatic dose checks, standardized supportive care, ability to use electronic decision support, increased completeness of orders, and other safety advantages seen in electronic prescribing of chemotherapy do improve the safe and effective care of patients who need chemotherapy.

References 1. Mertens WC, Christov SC, Avrunin GS, et al.

Using process elicitation and validation to understand and improve chemotherapy ordering and delivery. Jt Comm J Qual Patient Saff 2012:38(11):497-505.

2. Campbell E, Sittig D, Ash J, et al. Types of unintended consequences related to computerized provider order entry. J Am Med Inform Assoc. 2006;13(5):547-556.

3. Sklarin NT, Granovsky S, O’Reilly EM, et al.

Electronic chemotherapy order entry: a major cancer center’s implementation. J Oncol Pract.

2011;7(4):213-218.

4. Neuss MN, Polovich M, McNiff K, et al. 2013 updated American Society of Clinical Oncology/Oncology Nursing Society chemotherapy administration safety standards including standards for the safe administration and management of oral chemotherapy. J Oncol Pract.

2013;(2 Suppl):5s-13s.

5. Brockstein B, Hensing T, Carro GW, et al.

Effect of an electronic health record on the culture of an outpatient medical oncology practice in a four-hospital integrated health care system: 5-year experience. J Oncol Pract.

2011;7(4):e20-e24.

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