The February 2012 Digital Edition of Pharmacy Practice News

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The Pharmacist’s News Source

pharmacypracticenews.com

Volume 39 • Number 2 • February 2012

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Survey: More Work Needed To Boost Role of Technicians New Orleans—Although progress has been made in providing greater responsibilities and more comprehensive training for pharmacy technicians in the hospital setting, two surveys conducted by the American Society of HealthSystem Pharmacists (ASHP) suggest there is still much room for improvement.

More than 90% of the 372 pharmacists responding to one of the surveys agreed that “pharmacy technicians who have appropriate education, training and credentials could be used much more extensively to free pharmacists from drug distribution activities.”

Along those same lines, 91% of the respondents agreed that by freeing pharmacists from drug distribution, technicians “would make it possible to redeploy pharmacists’ time to

•

in this issue Up Front

Capsules FDA rule takes aim at drug shortages.

5

In Brief New tools for CAM therapy, NEJM turns 200 and FDA approvals/recalls.

6

Operations & Mgmt

Leadership in Action The servant leader, round 2: Who do you want to follow?

14

Workflow For ambulatory pharmacy services, a little outside help now available.

16

see PHARM TECHS, page 18

Finance

CDC Launches New System for Tracking Antibiotics in Hospitals

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or the first time, the Centers for Disease Control and Prevention (CDC) will be electronically tracking hospitals’ use of antimicrobial medications, using a new national system known as the AU (antimicrobial use) Initiative, part of the CDC’s National Healthcare Safety Network.

The new system requires very little additional effort on the part of hospital pharmacists: Data on antimicrobial use can be automatically captured and reported from the medication administration record via clinical document architecture.

For a hospital to participate, it must be using pharmacy software from a vendor that participates in the AU Initiative—a list that’s growing longer almost daily, and is available online from the Society of Infectious Diseases Pharmacists (SIDP) at www.sidp.org.

The new national system overcomes several problems that have plagued antimicrobial stewardship in hospitals, according to Elizabeth

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see TRACKING, page 13

Cutting IV waste yields major savings.

22

Policy

Reimbursement Matters Knowledge is power: the ABCs of new CMS payment rules.

Fiscal Stars That Glitter In Health-System Firmament new orleans— A few thousand here, a few hundred thousand there, and pretty soon you’re talking about real money. That sentiment—paraphrased from a line attributed to a U.S. senator in the 1960s—is taken seriously by health systems seeking every possible costcutting advantage.

In this second installment of a three-part series that debuted in December, PPN highlights the imaginative, successful and sometimes relatively simple programs that hospitals are using to rack up millions of dollars in savings annually. The strategies, ranging from minimizing the waste of costly drugs to internalizing functions that had previously been farmed out to external vendors, were presented at the 2011 American Society of Health-System Pharmacists Midyear Clinical Meeting.

The Christ Hospital Saves By Cutting ESA Waste Pharmacists at The Christ Hospital in Cincinnati saved more than $250,000 by determining the most appropriate dose-conversion ratios between two erythropoiesis-

26

Educational Review

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Methotrexate Drug Interactions: Are They Slipping Under Radar?

O Psychiatric Drug Interactions Explored: From the Literature to Clinical Practicality See page 7

see FISCAL STARS, page 20

n Dec. 21, the FDA issued a warning to physicians and pharmacists that administering a proton pump inhibitor (PPI) in conjunction with IV methotrexate could lead to elevated serum levels of the IV agent, potentially resulting in methotrexate toxicity. The warning cited case reports and pharmacokinetic studies.

But experts say that PPIs represent just the tip of the iceberg in terms of commonly used medications that may pose serious hazards when given concomitantly with methotrexate, a chemotherapy drug that also is used in the treatment of rheumatoid arthritis (RA).

“It’s pretty scary how many of these

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see METHOTREXATE, page 25

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Important Safety Information Levetiracetam in Sodium Chloride Injection is an antiepileptic drug indicated when oral administration is temporarily not feasible in adults (16 years and older) with: partial onset seizures; myoclonic seizures in patients with juvenile myoclonic epilepsy; primary generalized tonic-clonic seizures.

Levetiracetam should be gradually withdrawn to minimize the potential of increased seizure frequency.

Antiepileptic drugs (AEDs) increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Levetiracetam in Sodium Chloride Injection causes neuropsychiatric reactions including somnolence and fatigue, muscle coordination difficulties and behavioral abnormalities as well as hematological abnormalities. The most common adverse reactions observed with Levetiracetam were somnolence, weakness, infection and dizziness. Important behavioral adverse reactions include hallucinations, delusions, and non-psychotic mood disorders including suicide ideation, aggression, anger, apathy, conduct disorder, irritability, depression, nervousness, anxiety and emotional lability.

Dosing must be individualized according to seizure type, patient’s renal function status and therapy objective. Based on animal data, Levetiracetam may cause fetal harm and therefore should be used during pregnancy after consideration of the potential benefit-risk ratio. Levetiracetam should be gradually withdrawn to minimize the potential of increased seizure frequency.

Please see following pages for accompanying full Prescribing Information. ©2012 Mylan Institutional

JA025

January 2012

Brief Summary of Risk Information for LEVETIRACETAM IN SODIUM CHLORIDE INJECTION, for intravenous use WARNINGS AND PRECAUTIONS Neuropsychiatric Adverse Reactions Partial Onset Seizures: Levetiracetam can cause central nervous system adverse reactions: 1) somnolence and fatigue: levetiracetam 14.8%, placebo 8.4%. In a study without titration, 45% reported somnolence from 4000 mg/ day; considered “serious” by 0.3% levetiracetam, versus 0% of placebo patients; discontinuation: 3% levetiracetam, versus 0.7% of placebo patients; dose reduction: 1.4% levetiracetam versus 0.9% placebo; 0.3 % levetiracetam patients were hospitalized for somnolence. Asthenia: levetiracetam 14.7%, versus 9.1% placebo; treatment discontinuation: 0.8% versus 0.5% placebo; dose reduction: 0.5% versus 0.2% of placebo; 2) coordination difficulties (ataxia, abnormal gait, or incoordination): 3.4% levetiracetam versus 1.6% placebo; discontinuation from ataxia: 0.4% levetiracetam versus 0% placebo; dose reduction: 0.7% levetiracetam versus 0.2% placebo; one patient hospitalized from worsening of pre-existing ataxia. Somnolence, asthenia and coordination difficulties occurred most frequently within the first 4 weeks of treatment. 3) behavioral abnormalities (psychotic symptoms and other behavioral and mood symptoms): Psychotic symptoms: 5 (0.7%) levetiracetam versus 1 (0.2%) placebo. Two (0.3%) levetiracetam patients hospitalized and treatment discontinued. Both developed in the first treatment week, resolved in 1 to 2 weeks following discontinuation. Two events of hallucinations, occurred after 1-5 months and resolved within 2-7 days while remaining on treatment. One psychotic depression occurring within a month, resolved within 45 days while treatment continued. Other behavioral symptoms (aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, irritability, etc.): 13.3% levetiracetam versus 6.2% placebo; approximately half reported within the first 4 weeks; treatment discontinued in 1.7% levetiracetam versus 0.2% placebo; dose reduction in 0.8% levetiracetam versus 0.5% placebo.

Serious behavioral event causing hospitalization in 0.8% levetiracetam versus 0.2% placebo. Attempted suicide after 4-6 months treatment (one completed suicide) in 4 (0.5%) levetiracetam versus 0% placebo. Myoclonic Seizures: Somnolence and behavioral abnormalities: It is expected that the events seen in partial seizure patients would occur in patients with juvenile myoclonic epilepsy (JME). In JME patients JME experiencing myoclonic seizures: somnolence occurred in 11.7% of levetiracetam versus 1.7% of placebo patients (no treatment discontinuations); dose reduction in 1.7% levetiracetam versus 0% of placebo. Non-psychotic behavioral disorders (aggression and irritability): 5% levetiracetam versus 0% placebo. Non-psychotic mood disorders (depressed mood, depression, and mood swings) 6.7% levetiracetam versus 3.3% placebo.

Dose reduction or discontinuation: 5.0% of levetiracetam versus 1.7% placebo.

Primary Generalized Tonic-Clonic Seizures: Behavioral symptoms appeared to be associated with levetiracetam. Gait disorders and somnolence were described in patients with primary generalized seizures, but no difference between placebo and levetiracetam groups and no appreciable discontinuations.

In some patients levetiracetam causes behavioral abnormalities: irritability 6.3% levetiracetam versus 2.4% placebo. In patients with idiopathic generalized epilepsy, non-psychotic behavioral disorders (abnormal behavior, aggression, conduct disorder, and irritability): 11.4% levetiracetam (one discontinued due to aggression) versus 3.6% placebo; non-psychotic mood disorders (anger, apathy, depression, mood altered, mood swings, negativism, suicidal ideation, and tearfulness): 12.7% levetiracetam versus 8.3 placebo. Suicidal ideation in one levetiracetam patient. Delusional behavior in one patient requiring lowering of the levetiracetam dose. In a long-term open label study of various forms of primary generalized epilepsy, along with the non-psychotic behavioral disorders, 2 of 192 patients studied exhibited psychotic-like behavior, one characterized by auditory hallucinations and suicidal thoughts (led to drug discontinuation), the other as worsening of pre-existent schizophrenia (did not lead to discontinuation). Withdrawal Seizures: Antiepileptic drugs, including levetiracetam, should be withdrawn gradually to minimize the potential of increased seizure frequency. Hematologic Abnormalities: Minor, but statistically significant, decreases in total mean RBC count (0.03 x 106/mm3), mean hemoglobin (0.09 g/dL), and mean hematocrit (0.38%), were seen in levetiracetam patients. A total of 3.2% of treated and 1.8% of placebo patients had at least one possibly significant (≤2.8 x 109/L) decreased WBC, and 2.4% of treated and 1.4% of placebo patients had at least one possibly significant (≤1.0 x 109/L) decreased neutrophil count. Of the treated patients with a low neutrophil count, all but one rose towards or to baseline with continued treatment. No patient was discontinued secondary to low neutrophil counts.

Hepatic Abnormalities: No meaningful changes in mean liver function tests

(LFT) in controlled trials in adult patients; lesser LFT abnormalities were similar in drug and placebo patients in controlled trials (1.4%). No patients were discontinued from controlled trials for LFT abnormalities except for 1 (0.07%) adult epilepsy patient receiving open treatment. Laboratory Tests: Relatively infrequent abnormalities seen in hematologic parameters and liver function tests. ADVERSE REACTIONS: Most common (≥ 5%) versus placebo include: somnolence, asthenia, infection, and dizziness; important behavioral (< 5%) include depression, nervousness, anxiety, and emotional lability. See full prescribing information for adverse reactions in specific types of seizures and incidence when levetiracetam was added to concurrent AED therapy.

Postmarketing Experience: Additional adverse events reported worldwide (alphabetically): abnormal liver function test, hepatic failure, hepatitis, leukopenia, neutropenia, pancreatitis, pancytopenia (with bone marrow suppression identified in some), thrombocytopenia and weight loss. Alopecia was reported; recovery was observed in majority of cases where levetiracetam was discontinued. Reports of suicidal behavior (completed suicide, suicide attempt and suicidal ideation) with marketed levetiracetam. See Patient Counseling Information. USE IN SPECIFIC POPULATIONS. Pregnancy Category C: No adequate and well-controlled studies in pregnant women. Animal studies: evidence of developmental toxicity, including teratogenic effects, at doses similar to or greater than human therapeutic doses. Levetiracetam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. As with other antiepileptic drugs, physiological changes during pregnancy may affect levetiracetam concentration. There have been reports of decreased levetiracetam concentration during pregnancy. Discontinuation of antiepileptic treatments may result in disease worsening, which can be harmful to the mother and the fetus. North American Antiepileptic Drug Pregnancy Registry: Physicians are advised to recommend that pregnant levetiracetam patients enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry, toll free number 1-888-233-2334 (must be done by the patients themselves), website http://www.aedpregnancyregistry.org. Effect on Labor and Delivery: unknown. Nursing Mothers: Levetiracetam is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from levetiracetam, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Safety in Pediatric Use: Safety and effectiveness below age 16 years have not been established. Geriatric Use: No overall differences in safety were observed compared to younger subjects. Numbers of clinical trial subjects were insufficient to assess effectiveness in the elderly. A study in 16 elderly subjects (age 61-88 years) with oral administration of single dose and multiple twicedaily doses for 10 days showed no pharmacokinetic differences related to age alone. Levetiracetam is substantially excreted by the kidney, with concomitant risk of adverse reactions in patients with impaired renal function. Accordingly, care should be taken in dose selection for the elderly, and it may be useful to monitor renal function. Use in Patients with Impaired Renal Function: Clearance of levetiracetam is decreased in patients with renal impairment and is correlated with creatinine clearance. Caution should be taken in dosing patients with moderate and severe renal impairment and in patients undergoing hemodialysis. The dosage should be reduced in patients with impaired renal function receiving levetiracetam and supplemental doses should be given to patients after dialysis. OVERDOSAGE: Signs, Symptoms and Laboratory Findings of Acute Overdosage in Humans: The highest known dose of oral levetiracetam received in the clinical development program was 6000 mg/day.

Only drowsiness was observed in the few known cases of overdose in clinical trials. Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma observed in overdoses in postmarketing use.

Treatment or Management of Overdose: No specific overdose antidote. If indicated, elimination of unabsorbed drug should be attempted by emesis or gastric lavage; usual precautions to maintain airway. General supportive care is indicated including monitoring of vital signs and observation of clinical status.

A Certified Poison Control Center should be contacted for up to date information.

Hemodialysis: Standard hemodialysis procedures result in significant clearance of levetiracetam (approximately 50% in 4 hours) and should be considered in cases of overdose. Although hemodialysis has not been performed in the few known cases of overdose, it may be indicated by the patient’s clinical state or in patients with significant renal impairment. Patient Counseling: Patients should be advised to immediately report any symptoms of depression and/or suicidal ideation to their prescribing physician as suicide, suicide attempt and suicidal ideation have been reported in patients treated with levetiracetam. To report SUSPECTED ADVERSE REACTIONS, contact Mylan Institutional LLC at 1-877-4RX INFO or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Pharmacy Practice News • February 2012

Up Front 5

Capsules

FDA Rule Takes Aim at Drug Shortages

surf

FEBRUARY 2012

watch

The five most-viewed articles last month on pharmacypracticenews.com: 1. Practical Approaches for Handling Drug Shortages 2. Is QT Prolongation a Valid Reason To Abandon Zofran?

3. Stories of Success in Cutting Costs Yet Preserving Value 4. The ‘Second Victims’ of Medication Errors Begin To Gain Support 5. ACC Practice Network Shines Light on Medication Errors Register for free at pharmacypracticenews.com to read these and other articles on the latest developments in hospital pharmacy.

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n Jan. 18, an FDA interim final rule was slated to go into effect, broadening the circumstances under which the sole manufacturer of certain critical drugs must report to the FDA about stopping production. No longer will a company that interrupts, but does not permanently cease, the manufacture of a critical drug be exempt from the requirement to give the FDA a six-month advance notice.

According to a press release from the U.S. Department of Health and Human Services, the intent of the presidential executive order that led to the interim final rule was “to take action to help reduce and prevent drug shortages, protect consumers, and prevent stockpiling and exorbitant pricing of drugs in shortage.”

The FDA interim final rule does not establish monetary penalties for failure to provide the required advance notice. Senate bill 296 and House bill 2245 provide for monetary penalties; both bills await committee action.

Joseph M. Hill, director, Federal Legislative Affairs, American Society of HealthSystem Pharmacists, Bethesda, Md., said the new rule might have no direct impact on hospital pharmacies; it was likely to have “more impact on manufacturers having to report interruptions.” However, he said there is a “downstream hope” that with more information, the FDA may be able to work behind the scenes to help stop shortages. He called drug shortages a “very serious problem,” saying that 2011 was a record-setting year in number of shortages (267).

—George Ochoa

New Product

heard here first

‘If [a methotrexate] interaction results in extreme myelosuppression, then the patient has to be hospitalized, given broad-spectrum antibiotics and monitored for at least a week.

That’s costly to the system and unnecessary for the patient.’

Advertisement American Regent Launches Tranexamic Acid Injection

A

merican Regent, Inc. is proud to announce the availability of Tranexamic Acid Injection. Tranexamic Acid Injection is “AP” rated to Cyklokapron®, a product manufactured by Pfizer Health AB. Tranexamic Acid Injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. It works by blocking the breakdown of blood clots, which prevents bleeding.

American Regent will market the 1000 mg/10 mL (100 mg/mL) Single Dose Vial presentation in a convenient shelf pack of 10 vials (NDC: 0517-0960-10).

For more information, visit www.americanregent.com or call (1-800) 645-1706.

—Robert J. Ignoffo, PharmD

See article, page 1

Please see Important Safety Information and Brief Summary of Prescribing Information on pages 21 and 22

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Volume 39 • Number 2 • February 2012 • pharmacypracticenews.com

Anesthesiology/Pain Julie A. Golembiewski, PharmD, Chicago, IL Melvin E. Liter, MS, PharmD, FASHP, Lexington, KY

Internal Medicine

EDITORIAL STAFF

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Biotechnology

NUCLEAR PHARMACY

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6 Up Front

Pharmacy Practice News • February 2012

In Brief

The New England Journal at 200

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he New England Journal of Medicine is turning 200. From humble beginnings—the first issue in 1812 was distributed on horseback— NEJM now, in the words of its own Jan. 5, 2012, editorial, is “considered to be one of the premier journals in the field” (366:83).

The January 5 issue includes a historical overview of NEJM (366:1-7), featuring such highlights as the first demonstration of surgical anesthesia in 1846, and early clinical descriptions of AIDS. Allan M. Brandt, PhD, a historian of medicine at Harvard Medical School, in Boston, and author of the overview, said in an interview that NEJM “has

New Tools for Safe Use Of Complementary and Alternative Medicine

T

he American Pain Foundation (APF) has launched a new online educational module focusing on safe use of complementary and alternative medicine (CAM) as part of its PainSAFE (Pain Safety & Access For Everyone) initiative.

The module, developed with materials and assistance from the National Center for Complementary and Alternative Medicine (NCCAM), provides consumers and health care professionals information on the effectiveness of CAM therapies for managing pain, possible side effects and risks associated with each therapy and how these therapies can be used safely. CAM therapies highlighted include acupuncture, massage, spinal manipulation, relaxation therapies, yoga, tai chi and dietary supplements.

a long history of publishing cuttingedge science in a wide area of medical domains. At the same time, however, it has also published major articles in broad areas of health policy, medical ethics, and public health that draw together a diverse constituency of readers.”

NEJM editor-in-chief Jeffrey Drazen, MD, said the journal has 10 editors— nine physicians and one geneticist— “who spend a large amount of time seeking out and editing the best medical research in the world. Any research manuscript submitted for consideration as an original article or special article is reviewed and edited by at least five experts before it is

their treatment options, risks associated with each option, possible side effects and how these options can safely be used to manage their pain.”

PainSAFE, designed to reduce risk and improve access to quality pain care by providing people with pain and health care professionals information on the appropriate and safe use of pain management therapies, first launched in September 2010 with tools on opioid medications and implantable devices.

In spring 2011, PainSAFE expanded to include resources on over-the-counter medications (OTCs), such as acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs). An interactive Are You PainSAFE? quiz was recently added to allow people to test their pain safety knowledge. To learn more about safe use and risks associated with CAM therapy, opioid medications, implantable devices and acetaminophen and NSAIDS, visit www.painsafe.org.

—Based on a press release from the American Pain Foundation

Novartis Recalls Certain OTC Products

N

It is estimated that more than 83 million Americans use some form of CAM to manage and treat their health problems, including pain—spending more than $33.9 billion per year on out-of-pocket visits to CAM practitioners and purchases of CAM products, classes and materials.

Some of the most common pain-related reasons people seek CAM therapies are for back pain, followed by neck pain, joint pain, arthritis, severe headaches or migraines and fibromyalgia pain.

“What works for one person doesn’t always work for another,” said Will Rowe, CEO of APF. “An effective pain management plan must be individualized and very often an integrative approach, which includes a combination of treatment options, is needed. A person in pain should be informed about all of

ovartis Consumer Health, Inc., announced on Jan. 8, the voluntary recall of all lots of selected bottle packaging configurations from retailers of its aspirin painkiller Excedrin and NoDoz caffeine caplet products (expiration dates of Dec. 20, 2014, or earlier) and aspirin painkiller Bufferin and Gas-X Prevention products (expiration dates of Dec. 20, 2013, or earlier) in the United States. According to the FDA, reports were received of chipped and broken pills and inconsistent bottle-packaging clearance practices at Novartis’s facility in Lincoln, Neb., which could result in the bottles containing foreign tablets, caplets or capsules. The OTC recall follows the recent voluntary suspension of operations and shipments from the Lincoln facility.

Although Novartis said that it has not gotten reports of adverse events related to the issues leading to the recall, the mixing of different products in the same bottle could result in consumers taking the incorrect product and receiving a different strength than intended,

published.” Dr. Drazen told Pharmacy Practice News, “We purposefully edit the Journal so [clinicians] from all specialties can find something of interest.”

To mark its 200th anniversary, NEJM is publishing anniversaryrelated articles throughout the year.

or ingesting an unintended ingredient.

This could potentially result in overdose, interaction with other medications or an allergic reaction.

Novartis plans to resume operations at its Lincoln site gradually, after corrective action and in agreement with

FDA Approves Subsys Fentanyl Sublingual Spray

T

he FDA has approved the cancer pain medication Subys (fentanyl sublingual spray; Insys Therapeutics).

Subsys is a sublingually administered formulation of fentanyl indicated for episodes of breakthrough cancer pain.

Breakthrough cancer pain is characterized by sudden, often unpredictable episodes of intense pain that can peak in severity at three to five minutes despite background pain medication. Subsys is approved in cancer patients aged 18 years and older who are already receiving, and who are tolerant to, opioid therapy for their underlying persistent cancer pain.

Breakthrough cancer pain episodes can last anywhere from several seconds to hours, with the average episode lasting approximately 30 minutes. Breakthrough cancer pain is believed to occur in approximately one-third of patients being treated for cancer and up to 80% of patients with later-stage disease.

—Based on a press release from Insys Therapeutics

FDA Approves Azilsartan Medoxomil/ Chlorthalidone

T

he FDA has approved azilsartan medoxomil and chlorthalidone (Edarbyclor, Takeda Pharmaceutical Co. Ltd.) for the treatment of hypertension in adults. Azilsartan medoxomil/chlorthalidone is the only fixed-dose therapy in the United States to combine an angiotensin II receptor blocker (ARB) with the

It has also launched an anniversary Web site (http://nejm200.nejm.org) with an interactive historical timeline, plans to release a documentary and will host a symposium at Harvard Medical School.

—George Ochoa

the FDA. More information on the affected products and how to return them for refund is available at http:// www.novartisOTC.com.

—Based on press releases from Novartis and the FDA

diuretic chlorthalidone in a once-daily, single tablet. Both ARB azilsartan medoxomil (Edarbi, Takeda Pharmaceutical Co. Ltd.) and chlorthalidone are already on the market to treat hypertension.

According to Takeda, the safety and efficacy of the combination therapy was tested in five Phase III studies involving more than 5,000 patients with hypertension.

The studies ranged from eight to 52 weeks, with doses of azilsartan medoxomil/chlorthalidone ranging from 20/12.5 to 80/25 mg once daily.

The trials showed that azilsartan medoxomil/chlorthalidone lowered mean trough (22-24 hours) systolic blood pressure (SBP) by ambulatory blood pressure monitoring significantly more than either agent alone. Azilsartan medoxomil/ chlorthalidone lowered clinic SBP significantly more than the fixeddose combination of olmesartan medoxomil/hydrochlorothiazide at its highest approved dose (40/25 mg doses for both medications).

Azilsartan medoxomil/chlorthalidone lowered blood pressure in black and non-black patients at similar levels.

The most common adverse reactions seen in clinical studies of azilsartan medoxomil/chlorthalidone were dizziness and fatigue. The recommended starting dose is 40/12.5 mg and the maximum dose is 40/25 mg.

Azilsartan medoxomil/chlorthalidone may be used as an initial therapy if a patient is likely to need multiple drugs to achieve blood pressure control.

—Based on a press release from Takeda Pharmaceutical Co. Ltd.

Pharmacy Practice News • February 2012

Clinical 7

Educational Review

Psychiatric Drug Interactions Explored: From the Literature to Clinical Practicality Diane E. Hadley, William P. Albanese III, Charmaine D. Rochester, PharmD PharmD PharmD, BCPS, CDE PGY2 Ambulatory Care Pharmacy Resident University of Maryland School of Pharmacy Baltimore, Maryland

Pharmacist Beebe Medical Center Lewes, Delaware

Associate Professor Department of Pharmacy Practice and Science University of Maryland School of Pharmacy Baltimore, Maryland

M

anaging drug interactions is one of the crucial roles of pharmacists. Important in all aspects of pharmacy, drug–drug and drug–food interactions

are especially critical in the psychiatric world.

Often complicated by comorbid conditions and polypharmacy, psychiatric drug regimens are ticking time bombs for drug interactions that range from mild to severe (Table 1).1 Psychiatric drug interactions can result in serotonin syndrome (SS) and QT interval prolongation, and drug­–food interactions can occur between monoamine oxidase inhibitors (MAOIs) and tyramine-containing foods. This review explores the characteristics and treatment of SS and QT interval prolongation, and gives practical recommendations to circumvent MAOI–food interactions.

Serotonin Syndrome SS is a potentially life-threatening condition that is clinically avoidable through medication vigilance. The story of 18-year-old college freshman Libby Zion underscored the deadliness of SS and reshaped oversight of medical students since her death 25 years ago. A first-year medical resident in the 36th hour of her shift ordered meperidine for Libby, who had been taking phenelzine at home for depression. After receiving meperidine, Libby became combative with the staff and hyperthermic, with a temperature of 107°F. Her subsequent death, then called a cardiac arrest, is better described as SS. This story exemplifies the importance of the cause-and-effect relationship of drug interactions with SS and has led to the adoption of laws that limit medical residents’ scope of practice.2 Clinical Presentation and Severity Ranking SS is defined as a clinical triad of autonomic hyperactivity, neuromuscular changes, and altered mental status (Figure 1).3,5-7 SS occurs when drugs acutely elevate serotonin levels in the central nervous system (CNS), promoting a rapid

development of symptoms; 60% of patients with SS have clinical findings within 6 hours of taking a new medication that elevates serotonin levels.3,4 Most cases are mild and spontaneously resolve within 24 to 72 hours. More severe cases can lead to cardiac arrest, coma, and multiorgan system failure. Stratifying the clinical findings by severity helps to guide treatment because the spectrum of SS ranges from mild initial presentation of autonomic findings to severe deterioration resulting from hyperthermia.3-5 Drug Causes Drug mechanisms behind the increased serotonergic activity with proserotonergic agents include increased release of serotonin, inhibition of serotonin metabolism, direct receptor agonism, increased postsynaptic receptor response, impaired presynaptic reuptake, and increased serotonin formation.7 The term proserotonergic agents can be applied to many drug classes including selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), MAOIs, opioids, antiemetics, some antibiotics, amphetamines, bupropion, and over-the-counter products such as dextromethorphan and St. Johns wort.3,5,7 For instance, investigators showed that single doses of SSRIs are implicated in SS, and they found that SS developed in 15.4% of the cases when only 1 SSRI was ingested at toxic levels.8 Furthermore, as of October 2011, the FDA has issued a warning against prescribing either linezolid or methylene blue concurrently with any proserotonergic agents due to the risk for SS.9 Most of the cases reported to the Adverse Event Reporting

System (AERS) involved SSRIs or SNRIs with linezolid.9 The capacity to cause SS with the combination of linezolid and proserotonergic classes of drugs such as TCAs and MAOIs is still unclear.9 Treatment There are no randomized placebo-controlled trials or clinical practice guidelines to direct the clinician in the pharmacologic treatment of SS. Therefore, treatment is determined by the severity of symptoms.10 Regardless of severity level, the treatment of SS always starts with removal of the proserotonergic agents, provisions of supportive care, and the monitoring and control of agitation and hyperthermia. The time frame for resolution depends on the quantity and pharmacokinetic characteristics of the medication(s) taken. Treatment begins with the use of benzodiazepines for controlling agitation and mitigating the hyperadrenergic component of the syndrome. Medications like diazepam have been shown to improve survival in animal models.11 Additional treatment options for moderate and severe cases include neuromuscular paralysis and intubation, which have been shown to reduce body temperature. The 5-HT2A antagonists (eg, Text continues on page 8

8 Clinical

Pharmacy Practice News • February 2012

Educational Review Table 1. Drug Interactions by Class

SSRIs

SNRIs

MAOIs

TCAs

Opioids

Mild

Moderate

Antiemetics

Severe

Herbs

No identifiable interaction

Antibiotics

5HT1 Agonists

SSRIs SNRIs MAOIs TCAs Opioids Antiemetics Herbs Antibiotics 5HT1 Agonists MAOIs, monoamine oxidase inhibitors; SNRIs, serotonin-norepinephrine reuptake inhibitors; SSRIs, selective serotonin reuptake inhibitors; TCAs, tricyclic antidepressants Based on reference 1.

by muscular activity.3 Clinicians can few days of fluoxetine.15,16 Additional- amounts of dietary tyramine are chlorpromazine) offer a parenteral misdiagnose neuroleptic malignant ly, newer classes of antidepressants ingested by a patient taking a MAOI. option for treatment and can ame- syndrome instead of SS and give bro- such as SSRIs have replaced MAOIs in Tyramine is a sympathomimetic amine liorate symptoms within 2 hours.11,12 mocriptine.3 This can be a highly det- clinical practice (despite MAOIs being found in a wide variety of foods and Cyproheptadine offers an oral option; rimental mistake because bromocrip- effective in treating major depres- beverages.18 When ingested, tyramine doses as high as 32 mg in a 24-hour tine has been reported to increase sive disorder especially with atypical becomes inactivated in the intestine period may be required to allow the brain 5-HT levels.14 For example, a features and in treatment-resistant and liver before it enters the systemmedication to penetrate the blood– case report illustrated that the use depression).15 The nonselective, irre- ic circulation. However, when a patient brain barrier. Doses at or above 30 of bromocriptine in SS caused the versible MAOIs available in the Unit- is taking a MAOI, tyramine will enter mg have been shown to achieve a patient’s temperature to rise from ed States are phenelzine, isocarboxa- the systemic circulation in an active blockade of the 5-HT2A receptors in 100.5°F to 106°F within 3 hours, with zide, and tranylcypromine for depres- state. Once in the systemic circulathe brain at 85% to 95%.13 Although death ensuing.14 sion.17 Selegiline, a selective MAOI at tion, tyramine will be taken up by the the efficacy of these agents has not low dosages (5-10 mg daily), is used adrenergic neurons and displace norbeen rigorously established, it has MAOIs for adjunctive treatment of Parkin- epinephrine from its binding sites; this MAOIs were the first drugs used son’s disease, but at higher doses (20- is called a “cheese” reaction because been supported by extensive animal model testing and post hoc analysis for treating depression in the 1950s.15 60 mg/day), MAO-B selectivity is lost it was first identified in a patient eatAfter 2 decades, there was a signif- and the antidepressant effect is seen.15 ing aged cheese with a high tyramine of case reports.12,13 Certain medications should not icant decline in their use because of concentration.19 The intake of 6 to 10 be used in the management of SS. adverse effects, drug–food interac- MAOI–Tyramine (Food) Interaction: mg of tyramine is required for a mild Antipyretic agents have no utility in tions, and drug–drug interactions. This Rationale for Dietary Restrictions reaction to occur in a patient taking a lowering the temperature because is shown in case studies by Beasley One of the major concerns with MAOI, and 10 to 25 mg of tyramine is the hyperthermia is not caused by a et al of 7 deaths that occurred when MAOIs is the interaction that can lead required for a severe reaction.19 There Text continues on page 10 hypothalamic response but instead tranylcypromine was started within a to a hypertensive crisis when large Text continued from page 7

SEVERITY

SIGNS/SYMPTOMS

Mild

Hyperreflexia, tremor, clonus (induced, ocular, or spontaneous), shivering, diaphoresia, tachycardia (afebrile)

TREATMENT

1. Supportive care

Moderate

Hypertension, mydriasis, hyperactive bowel sounds, mild agitation, tachycardia (febrile), core temperature <106°F

Severe

Hyperthermia >106° F, severe hypertension, hypervigilance, hypertonicity, delirium, coma

1. 5-HT2A antagonists to block serotonin receptors in the CNS:

cytoheptamide 12 mg initially, then 2 mg q2h, olanzapine 10 mg, chlorpromazine 50-1,000 mg IM

2. Neuromuscular blockade to stop isometric muscle contractions that further elevate temperature:

vecuronium, rocuronium, cisatracurium 3. Blood pressure:

esmolol and/or nitroprusside

Figure 1. Signs, symptoms, and treatment of serotonin syndrome by severity.

CNS, central nervous system Based on references 3, 5-7.

2. Discontinue: serotonergic medications

3. Benzodiazepines: diazepam for sedation

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10 Clinical

Pharmacy Practice News • February 2012

Educational Review Text continued from page 8

is evidence that the resulting increase in blood pressure can result in a hypertensive crisis, leading to CNS and heart damage.20 For a food to have a high tyramine content, it must have undergone protein changes as a result of aging, fermentation, pickling, or smoking; be stored for long periods; or be improperly refrigerated. Examples of foods with high tyramine content include aged cheeses, fermented or air-dried meats, sauerkraut, soy sauce, and tap beers. Although small quantities of more than 200 tyramine-containing foods have been associated with a reaction with MAOI therapy, most likely these reactions are due to the consumption of spoiled foods.20

Table 2. Food Restrictions in Patients Taking MAOIs Food Category

QTc Prolongation Malfunction of the myocardial ion channels can result in increased sodium influx or decreased potassium efflux, leading to an extended repolarization, a prolonged QT interval and arrhythmias such as torsades de pointes (TdP).24 Clinically, the prolonged QT interval predisposes a patient to syncope, seizures, and arrhythmias, specifically TdP, which can lead to sudden death.25 In a healthy individual, the QT interval is typically 400 milliseconds, with the interval being slightly longer in women than men. True “prolonged” QT ranges from 450 to 500 milliseconds because controversy exists on this subject. It is well known, however, that as QT interval becomes increasingly prolonged, the risk for

Foods To Eat Without Restrictions

Beverages, chocolate

• Wines (red, white, port, vermouth, nonalcoholic wines); beer/ale (including nonalcoholic beer), whiskey and liqueurs (Drambuie and Chartreuse)

• Caffeine contains a weak pressor agent; large amounts of caffeine-containing foods/ drinks may cause a reaction

Dairy products

• Cheese (except cream cheese and cottage cheese)

• Cream, sour cream, yogurt, cottage cheese or cream cheese if close to the expiration date

• Cream cheese, cottage cheese not close to expiration date, boiled eggs

Fish, seafood

• Smoked, fermented, pickled fish or herring, aged fish, spoiled fish, and shrimp paste all contain a large amount of tyramine

• N/A

• Fresh fish or vacuumpacked pickled fish and caviar if refrigerated and stored properly

Meat, nuts, poultry, protein extracts

• Spoiled or unfresh livers, meat extracts, liquid and powdered protein dietary supplements, sausage, pepperoni, salami, bologna, soups with protein extract, miso soup (contains fermented bean curd)

• Large quantities of peanuts, coconuts and brazil nuts cause pressor reactions

• Fresh meat, snails, canned wild game, cockles, canned fish, and country cured ham

Fruits, vegetables

• Broad (fava) bean pods, especially if overripe (can contain dopamine and can cause a pressor effect)

• Avocados (use with caution if overripe), raspberries, New Zealand prickly or hot weather spinach (use in small quantities)

• Anchovies, figs (fresh or canned), raisins, beetroot, cucumbers, sweet corn, mushrooms, pineapples, fresh tomato juice

Breads, yeast

• Yeast extracts (Marmite), which are spread on bread or mixed with water, Brewer’s yeast, or yeast vitamin supplements

• Gourmet pizzas that may contain aged cheeses

• Yeast-leavened bread and pizzas from large chains commercial outlets

Other

• Ginseng, sauerkraut

• Teriyaki soy sauce, especially with fermented meat

• Worcestershire sauce, chips with vinegar, salad dressings

Counseling Tips Patients on MAOIs should be counseled to avoid protein-containing foods that were not correctly stored, stored for prolonged periods, mishandled, decomposed, contaminated, or expired because the tyramine can denature to amines, which lead to pressor effects. Patients should purchase food from trusted vendors to avoid foods with large quantities of tyramine (>6 mg). A general rule of thumb would be to use small servings (1/2 cup or <120 mL) because this should not pose undue harm to patients.18 Table 2 lists the foods that must be avoided by patients taking MAOIs due to high tyramine content, those that must be used with caution, and those that can be used safely with MAOIs.21-23 Selegiline, at low dosages (5-10 mg daily), does not need dietary restriction; however, at 20 to 60 mg per day, when selectivity is lost, patients should be counseled to follow dietary restrictions similar to those of the other nonselective agents.15

Foods To Use With Caution (1/2 cup or <120 mL)

Foods To Avoid

MAOIs, monoamine oxidase inhibitors Based on references 21-23.

Table 3. Agents That Increase the Risk for QT Interval Prolongation Antipsychotics, Antidepressants, and Mood Stabilizers • Amitriptyline • Aripiprazole • Chlorpromazine • Clozapine • Droperidol • Fluoxetine • Haloperidol • Lithium • Nortriptyline • Olanzapine • Pimozide • Quetiapine • Risperidone • Thioridazine • Ziprasidone

Antibiotics

Anti-arrhythmic Drugs

Miscellaneous Medications

• Clarithromycin • Erythromycin • Fluoroquinolones

• Amiodarone • Disopyramide • Dofetilide • Dronedarone • Flecainide • Ibutilide • Procainamide • Quinidine • Sotalol

• Arsenic • Cisapride • Cocaine • Digoxin • Diphenhydramine • Methadone • Ondansetron • Sumatriptan • Tacrolimus • Zolmitriptan

Based on references 25, 27, and 30-32.

arrhythmias increases dramatically.26 Because a rapid heart rate can lead to a shortened QT interval, a prolonged QT interval often is expressed as the heart rate–corrected QT interval, or QTc.26,27 There are several risk factors that predispose a patient to TdP or prolonged QT, including female sex, menstruation, advanced age, electrolyte

imbalances (hypokalemia, hypomagnesemia, hypocalcemia), preexisting cardiac disease (structural heart disease, myocardial infarction, heart failure, valvular disease, or cardiomyopathy), recent cerebrovascular accident or trauma, multiple QT-prolonging drugs, higher than average drug dosage, prolonged baseline QTc greater than 450 milliseconds, family

history of congenital QT prolongation, prior drug-induced TdP, and drug interactions.26,27 QT prolongation and TdP are the most frequent reasons for black box warnings and discontinuation of drugs from the US market.28 QT interval prolongation often is a result of drug interactions; however, it also can occur with only one agent. Some

Pharmacy Practice News • February 2012

Clinical 11

Educational Review medications prolong QTc in a dosedependent fashion, whereas others will precipitate TdP at any dosage. It is important for pharmacists to be familiar with cytochrome (CYP) P450 CYP3A4 inhibitors because many of the agents that prolong QT are metabolized by these enzymes.27 Antipsychotic medications have been associated with QT prolongation since 1963.29 Table 3 lists mainly psychiatric agents as well as other drugs well known to prolong the QT interval.25,27,30-32 It is not comprehensive

but is meant to highlight the fact that a majority of psychiatric medications place the patient at an increased risk for QT prolongation. For a comprehensive list of QT-prolonging drugs, visit http://www.qtdrugs.org.

Pharmacist Management For Prevention and Treatment Pharmacists should discuss with the physician whether the agent(s) should be continued when the risk for QT prolongation is established.

During the monitoring stage, one

intervention a pharmacist can recommend is an electrocardiogram (EKG) to assess if QT prolongation is present. Psychiatric agents can be defined as having high, moderate, and low risk, which translates into a recommendation about whether an EKG is imperative or not necessary to assess the QT interval.30 Drugs associated with the highest risk are those that have demonstrated QT prolongation as a single agent, such as thioridazine, haloperidol (IV— large doses), and most other typical

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antipsychotics.30 Moderate agents include atypical antipsychotics such as quetiapine (Seroquel, Seroquel XR, AstraZeneca) and ziprasidone (Geodon, Pfizer), whereas the remaining members of the atypical antipsychotic class—and oral haloperidol—are low risk.30 EKG monitoring is essential when high-risk medications are used but they are recommended only when necessary when moderate- and low-risk psychiatric medications are used.30 Agents that may be used to treat ventricular arrhythmia due to QT prolongation include magnesium, potassium, calcium, verapamil, and isoproterenol.27,33,34 IV magnesium is beneficial in patients with pre-torsades arrhythmias as well as ventricular arrhythmia.27,33 Isoproterenol is contraindicated in patients with congenital QT prolongation; therefore, a comprehensive arrhythmia history is imperative.27 If a patient is not responding to therapy, as outlined above, then cardiac shock should be considered.27 Patients who experience a ventricular arrhythmia or persistent QT prolongation should be evaluated for implantable cardioverter-defibrillator placement.27

Summary

Get the latest news delivered directly to your computer and PDA. The new interactive format has embedded Web site links that give you instant access to additional information as well as unique searching features and printing capabilities.

Each installment contains brief summaries of the most important articles from the current month’s issue, and breaking news ahead of print.

With their pharmacologic knowledge, pharmacists are key players in the early detection, treatment, and prevention of psychiatric drug–drug or drug–food interactions. The case study described in the box (page 12) illustrates how a proactive approach by the pharmacists can result in a successful management program in any setting.35,36 Pharmacists’ knowledge of the potency, pharmacokinetics, and pharmacodynamics of medications is needed to manage psychiatric disorders, providing a necessary framework for improved patient care.

References 1. Lexi-Comp online drug database. http:// online.lexi.com.proxy-hs.researchport.umd. edu/crlsql/servlet/crlonline?siteid=2000.

Accessed January 26, 2012.

2. Lerner B. A life-changing case for doctors in training. New York Times. Aug 14, 2011.

3. Boyer EW, Shannon M. The serotonin syndrome. N Engl J Med. 2005;352(11):1112-1120.

4. Teter CJ, Kando JC, Wells BG et al.

Depressive disorders. In: Pharmacotherapy: A Pathophysiological Approach. 7th ed.

New York, NY: McGraw-Hill; 2008:1123-1140.

5. Dunkley EJ, Isbister GK, Sibbritt D, Dawson AH, Whyte IM. The Hunter Serotonin Toxicity Criteria: simple and accurate diagnostic decision rules for serotonin toxicity. QJM. 2003;96(9):635-642.

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6. Hick JL, Smith SW, Lynch MT. Metabolic acidosis in restraint-associated cardiac arrest: a case series. Acad Emerg Med. 1999;6(3):239-243.

Text continues on page 12

12 Clinical

Pharmacy Practice News • February 2012

Educational Review

Case Study Presentation JT is a 20-year-old black woman with treatment-resistant depression and sickle cell anemia who presented to the emergency room (ER) for pain control due to a sickle cell crisis. She stated that her pain was a 10 on a scale of 1 to 10, with 10 being the worse pain experienced. In the ER, the medical resident administered IV fluids, and meperidine 50 mg for pain; then, 1 hour later, he administered another dose of 100 mg of meperidine because the patient was still in severe pain.

Six hours later, the patient became agitated and confused. She experienced several episodes of nausea, vomiting, diarrhea, shivering, and tremors. Her vitals were as follows: blood pressure, 198/120 mm Hg (baseline 120/70 mm Hg); heart rate, 110 beats per minute; respiratory rate, 22 breaths per minute; and temperature, 101°F. Her neurologic examination was positive for hyperreflexia, particularly of the lower extremities, and rigidity. Laboratory results revealed no abnormalities. Computed tomography of the head showed normal results.

Past Medical History Sickle cell anemia with frequent sickle cell crises; major depression (×13 years); allergic rhinitis; common cold virus.

Home Medications Phenelzine 90 mg daily (×2 years); lithium 10 mg daily (×2 years); ibuprofen 800 mg 3 times daily as needed for pain (×5 years); loratadine/ pseudoephedrine 1 tablet daily as needed (×3 days); guaifenesin/dextromethorphan 200 mg/20 mg/10 mL oral liquid 10 mL orally every 4 to 6 hours as needed (×3 days).

Discussion The medical team diagnosed SS in the patient. This patient’s profile included 3 medications that are absolutely contraindicated in combination with phenelzine—meperidine, dextromethorphan, and pseudoephedrine— as well as several that should be used with caution.21 The administration of the MAOI phenelzine along with meperidine can produce agitation, headache, diaphoresis, hyperpyrexia, rigidity, hypertensive crisis, seizures, and coma, which can be fatal. Phenelzine, by inhibiting serotonin metabolism, can increase CNS synaptic

Text continued from page 11

7. Taylor JJ, Wilson JW, Estes LL. Linezolid and serotonergic drug interactions: A retrospective survey. Clin Infect Dis. 2006;43(2):180-187.

8. Lorenz RA, Vandenberg AM, Canepa EA. Serotonergic antidepressants and linezolid: a retrospective chart review and presentation of cases. Int J Psychiatry Med. 2008;38(1):81-90.

9. US Food and Drug Administration.

Drug Safety Communication: Updated information about the drug interaction between linezolid (Zyvox) and serotonergic psychiatric medications. http://www.fda. gov/Drugs/DrugSafety/ucm276251.htm.

Accessed January 17, 2012.

10. Frank C. Recognition and treatment of serotonin syndrome. Can Fam Physician.

2008;54(7):988-992.

11. Gillman PK. The serotonin syndrome and its treatment. J Psychopharmacol.

1999;13(1):100-109.

serotonin by synergizing with other proserotonergic agents such as dextromethorphan and meperidine, leading to an increased risk for SS. Finally, because of enhanced norepinephrine storage in adrenergic neurons and increased release from sympathomimetic amines such as pseudoephedrine, there can be an increased risk for severe hypertensive reactions and hyperpyrexia. A hypertensive reaction, in addition, can occur with the combination of a decongestant and MAOI. The direct stimulation of a1 receptors by pseudoephedrine combined with the adrenergic actions of a MAOI can elevate blood pressure, causing a hypertensive crisis. This patient should avoid decongestants containing phenylephrine or pseudoephedrine and any other cough or cold products that inhibit serotonin reuptake (dextromethorphan, chlorpheniramine, and brompheniramine). She can be advised to use acetaminophen with codeine products. In addition to the above-mentioned contraindicated medications, this patient profile includes several medications, such as lithium, that should be used with caution with phenelzine or meperidine. Although not contraindicated, both can potentiate CNS or respiratory depression and cause extreme sedation, delirium, hypotension, respiratory depression, and coma.21,35 Treatment All medications were immediately discontinued, and the patient was hospitalized and aggressively hydrated with IV fluids to ensure adequate urine output. The team administered IV diazepam 10 mg every 5 to 10 minutes as needed for muscle hyperactivity and agitation. JT was monitored for respiratory depression and the need for intubation.

For hyperthermia, she was cooled with the use of ice packs and cooling fans. For hypertension, she received IV nitroglycerin. The patient received 4 to 8 mg of cyproheptadine every 4 hours until therapeutic response was observed, and she was monitored for temperature, pulse, blood pressure, and urine output.36 By treatment day 2, the patient’s blood pressure and temperature had returned to baseline, and her clinical symptoms had abated. She was discharged from the hospital with psychiatric follow-up. The patient should be counseled to avoid potential toxicity from the combination of serotonergic drugs. The medical team should have updated software to evaluate for drug–drug interactions with proserotonergic therapies. In the future, it is hoped that pharmacogenomics principles may protect patients like JT who are at risk for SS.

14. Kline SS, Mauro LS, Scala-Barnet DM, Zick D. Serotonin syndrome versus neuroleptic malignant syndrome as a cause of death.

Clin Pharm. 1989;8(7):510-514.

22. Tong TG Saklad SR. Foods to avoid when taking monoamine oxidase inhibitors. http://www.biopark.org/maoi-1.htm.

Accessed January 19, 2012.

29. Glassman AH, Bigger JT Jr. Antipsychotic drugs: prolonged QTc interval, torsade de pointes, and sudden death. Am J Psychiatry. 2001;158(11):1774-1782.

15. Wimbiscus M, Kostenko O, Malone D. MAO inhibitors: risks, benefits and lore. Cleve Clin J Med. 2010;77(12):859-882.

23. Walker SE, Shulman KI, Tailor SA, Gardner D. Tyramine content of previously restricted foods in monoamine oxidase inhibitor diets. J Clin Psychopharmacol.

1996;16(5):383-388.

30. Vieweg VW. New generation antipsychotic drugs and QTc interval prolongation.

Prim Care Companion J Clin Psychiatry.

2003;5(5):205-215.

16. Fischer P. Serotonin syndrome in the elderly after antidepressant monotherapy [letter]. J Clin Psychopharmacol.

1995;15(6):440-442.

17. Fiedorowixz JG Swartz KL. The role of monoamine oxidase inhibitors in current psychiatric practice. J Psychiatry Pract.

2004;10(4):239-248.

18. Blob LD, Sharoky M, Campbell BJ, et al. Effects of a tyramine-enriched meal on blood pressure response in healthy male volunteers treated with selegiline transdermal system 6 mg/24 hour.

CNS Spectr. 2007;12(1):25-34.

19. McCabe BJ. Dietary tyramine and other pressor amines in MAOI regimens: a review.

J Am Diet Assoc. 1986;86(8):1059-1064.

12. Nisijima K, Shioda K, Yoshino T, Takano K, Kato S. Diazepam and chlormethiazole attenuate the development of hyperthermia in an animal model of the serotonin syndrome. Neurochem Int. 2003;43(2):155-164.

20. Rumore MM, Roth M, Orfanos A. Dietary tyramine restriction for hospitalized patients on linezolid: an update. Nutr Clin Pract. 2010;25(3):265-269.

13. Kapur S, Zipursky RB, Jones C, Wilson AA, DaSilva JD, Houle S. Cyproheptadine: a potent in vivo serotonin antagonist. Am J Psychiatry. 1997;154(6):884.

21. Shulman KI, Walker SE. Refining the MAOI diet: tyramine content of pizzas and soy products. J Clin Psychiatry. 1999;60 (3):191-193.

24. Thompson JL CR. Drug-induced QT prolongation. US Pharmacist. http://www. uspharmacist.com/content/d/featured%20 articles/c/10396/. Accessed January 17, 2012.

25. Sanoski CA, Bauman JL. The arrhythmias.

In: Pharmacotherapy: A Physiologic Approach. 8th ed. New York, NY: McGrawHill; 2011:273-309.

26. Huffman JC, Stern TA. QTc prolongation and the use of antipsychotics: a case discussion. Prim Care Companion J Clin Psychiatry. 2003;5(6):278-281.

27. Gupta A, Lawrence AT, Krishnan K, Kavinsky CJ, Trohman RG. Current concepts in the mechanisms and management of drug-induced QT prolongation and torsade de pointes.

Am Heart J. 2007;153(6):891-899.

28. Lasser KE, Allen PD, Woolhandler SJ, Himmelstein DU, Wolfe SM, Bor DH. Timing of new black box warnings and withdrawals for prescription medications. JAMA. 2002;287(17):2215-2220.

31. Yap YG, Camm AJ. Drug induced QT prolongation and torsades de pointes.

Heart. 2003;89(11):1363-1372.

32. Hansten PD, Horn JR. The Top 100 Drug Interactions: A Guide to Patient Management. 2005 edition. Edmonds, WA: H&H Publications.

33. Blue Ridge Poison Center. Tox talks. A bulletin for Health Care Professionals Who Manage Poisoned Patients. July 2008;6:1-2.

34. Bogaard K, van der Steen, Tan HL, Tukkie R. Short coupled variant of torsade de pointes.

Neth Heart J. 2008;16(7-8):246-249.

35. Drugs.com. http://www.drugs.com/ interactions-check.php?drug_list=8460,1310-0,1477-0,1839-0,1487-9765. Accessed January 17, 2012.

36. Ables AZ, Nagubilli R. Prevention, diagnosis and management of serotonin syndrome.

Am Fam Physician. 2010;81(9):1139-1142.

Drs. Hadley, Albanese, and Rochester report no relevant conflicts of interest.

Pharmacy Practice News • February 2012

Clinical 13

Infectious Disease

TRACKING continued from page 1

Hermsen, PharmD, MBA, president of SIDP and the Midwest clinical scientific director for Cubist Pharmaceuticals. Dr. Hermsen was involved in the early advisory panels for the AU Initiative while heading up antimicrobial stewardship for The Nebraska Medical Center, in Omaha.

“Tracking antimicrobial utilization at the hospital level is a very laborious and time-consuming process, and there’s room for a lot of errors to be made. For example, if a product moved from branded to generic, the entry in the hospital information system changed. If someone wasn’t staying on top of that, you’d discover errors after the fact,” Dr. Hermsen said. “And once you clean up the errors and you know your utilization, what do you do with that information? Is it good or bad?”

The CDC’s new automated system reduces the potential for error—as well as diminishes much of the work—and it will also allow hospitals to compare their own data with nationwide benchmark information, according to its developers.

“Universally, when we look at antibiotic use data, we want to know how we compare to similar institutions,” said Elizabeth Dodds Ashley, PharmD, MHS, BCPS, associate director for clinical pharmacy services and an infectious diseases pharmacist at the University of Rochester Medical Center in Rochester, N.Y. “Health care is moving in the direction of targeting unnecessary variance, and you want to know if you’re an outlier in a particular area.

There might be an easy explanation for it, such as if one institution has a transplant program and another doesn’t, but when there isn’t such an explanation, it’s worth taking a closer look.”

Dr. Dodds Ashley added that her institution currently has no means to easily compare its data on antibiotic use with those at other institutions. “If we’re having a problem with a certain infection or seeing a rise in use of a particular agent, we wonder how we might change our antibiotic use to address that. It would be helpful to look at similar centers that don’t have such a problem, or who have resolved it, and see what they do,” she said. “But I have no great way of doing that right now other than calling colleagues and asking them, which is timeconsuming and unreliable since we may not all use the same metric.”

Because of the automated capture of not just what antibiotics were prescribed, but exactly what dosages were administered, the CDC program will eliminate that variance.

‘Health care is moving in the direction of targeting unnecessary variance, and you want to know if you’re an outlier in a particular area.’

—Elizabeth Dodds Ashley, PharmD

ASHP on Board About 70 hospitals are already involved in the AU Initiative, and the CDC, the SIDP and the American Society of Health-System Pharmacists (ASHP) are encouraging more to enroll.

“This is a great way to collect this data that’s fairly unobtrusive,” said Karl

Gumpper, RPh, BCNSP, BCPS, FASHP, director of ASHP’s Section of Pharmacy Informatics and Technology.

“Hopefully, now we will be able to spot trends where we might need to change practices to ensure that we are using antibiotics wisely and appropriately.”

If your pharmacy software comes

from a vendor that is already on the CDC list of participating companies, then there is nothing more you need to do, Dr. Dodds Ashley stressed. “The CDC can directly take data from any of the vendors who are actively participating,” she said. If your software provider isn’t on board yet, Drs. Dodds Ashley and Hermsen encourage pharmacists to speak up at the institutional level and ask for AU Initiative compliance through the software vendors.

—Gina Shaw

14 Operations & Management

Pharmacy Practice News • February 2012

Leadership in Action

Being a Servant Leader in Pharmacy W

hen asked the penetrating question, who are the people I desire to follow, my answer is those with whom I have alignment in thought, persuasion and goal. It is the people who have my best interest at heart and are helping me to move in an agreed-upon direction.

Another way to state it is people who are servant leaders. Now, flip it around: Who are the people I want to follow me?

It’s those for whom I need to be a servant leader. Servant leaders and followers are people who are always mutually searching for a better way.

What type of leadership do we respond to by doing our best? Is it that authoritative, coercive, top-down type of leadership? Probably not. Who are the people to whom we can give our all?

Think of the many bosses you have had over the years. Great pharmacy leaders tend to be very committed, dedicated, self-motivated individuals. We are most successful, however, when we have a supportive boss who takes the time to understand the role of pharmacists and the benefit we can provide to patient care. In that way, our best bosses are serving us through understanding rather than dictating to us in a vacuum.

In his book Servant Leadership, A Journey into the Nature of Legitimate Power and Greatness (Paulist Press, 2002), Robert Greenleaf states, “A new moral principle is emerging, which holds that the only authority deserving one’s allegiance is that which is freely and knowingly granted by the led to the leader in response to and in proportion to, the clearly evident servant stature of the leader.” He further states that followers “will freely respond only to individuals who are chosen as leaders because they are proven and trusted servants.”

Leaders are individuals who can visualize the goal and communicate it effectively to others so that they too will want to come along and help pave the future.

Often, all the answers are not yet apparent. There is a sense of risk. The leader must be a great listener to understand the challenges ahead and synthesize potential solutions. This involves listening not only to those outside our immediate domain, but more importantly to people on our staff who can help us fully understand the issues to create a vision. Listening first is part of the servant nature that says, “I value you” and builds strength in others. Great leaders help others see the possibilities and create alignment within a paradigm. The followers must explicitly trust their leaders’ visionary goal.

Echoes of PPMI This brings to mind pharmacy’s current overarching goal of the Pharmacy Practice Model Initiative. This goal for

pharmacy is synergistic within the paradigm of health care reform. Pharmacists have proven time and time again that we are instrumental to cost-effective patient care and to getting patients to therapeutic goals and outcomes that are consistent with the quality measures now required under the Accountable Care Act. Pharmacy leaders create that vision by putting the pieces together in a way that is apparent to those above and

below them. The risk comes in when all the answers are not apparent but you move ahead anyhow. Leaders have the ability and confidence to do this. It may be that sense of intuition that followers trust in their leader. It often is a good track record that builds this level of trust in the intuition of the leader. In some respects, the leader, as Greenleaf states, is “an historian, a contemporary analyst and prophet” all at once. Lead-

“Leadership in Action” is authored by Ernest R. Anderson Jr., MS, RPh, System Vice President of Pharmacy, Steward Health Care System, Boston, Mass.

Mr. Anderson welcomes your input on leadership issues, at ernest.anderson@ steward.org.

Ernest R. Anderson Jr., MS, RPh

ers have a sense of confidence in facing the future unknowns, generally more than their followers do.

In any organization (department or institution), there must be a balance between those who can conceptualize

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Operations & Management 15

Leadership in Action and those who can operationalize. We often distinguish this as the difference between leadership and management.

Those who conceptualize have the ability to look at the past and paint a longrange strategic plan. They effectively persuade and build lasting relationships.

People with operative talents carry the organization toward meeting objectives on a day-to-day basis. This requires good interpersonal skills, tenacity, experience, judgment, ethical soundness and the ability to motivate others toward goals. Both the conceptual and operational leaders

have the opportunity to be a servant leader. In any organization, both types of leaders are essential and rarely interchangeable. Leaders usually fall into one

camp or the other. Therefore, it is imperative to know and distinguish between these two types of individuals and place each in the correct role. To be effective, each type of leader must gain the trust of those they are leading. Leadership by persuasion and by example, rather than by coercion, is the way to be effective.

As pharmacy moves forward in these coming months with many unknowns of health care reform, it is important to listen and understand the many stakeholders within the health care debate.

As leaders, we must position pharmacy

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as providing a solution to health care challenges and educate and motivate those around us. With a servant leader attitude of demonstrating the value that we represent to patient care, we must encourage others to see this unique value. Pharmacists are the medication experts, and we all can serve others and promote our profession through quality health care that is cost-effective and patient-centered. This will take multidisciplinary teams and attitudes that serve others through innovative leadership. I trust that we are up to the task.

16 Operations & Management

Pharmacy Practice News • February 2012

Practice Models

McKesson Unveils Ambulatory Pharmacy Solutions A

growing body of literature suggests that ambulatory pharmacy services save money and improve patient outcomes—a finding not lost on McKesson Corporation. In December, the health care services and information technology company announced a portfolio of products for hospitals that are interested in adding to or expanding their ambulatory care offerings.

The goal of the initiative isn’t simply

to be a cost saver, stressed Chris Borr, FACHE, vice president of marketing at McKesson. The new program, dubbed McKesson Ambulatory Pharmacy Solutions, can help hospitals capture new revenue, improve workflow efficiency and extend the continuum of care for improved clinical outcomes, he noted.

“There is no doubt that there are sources of revenue that health systems haven’t really tapped into that dovetail with their

financial concerns, and there are opportunities to streamline the transition from inpatient care to outpatient care,” Mr. Borr said. “But most important in ambulatory pharmacy is allowing the health system to engage in the continuum of care for patients and make sure that care is sustainable post-discharge, so patients will get better and not be readmitted within 30 days, when hospitals will have to eat the cost.”

THIS MONTH

Bridging the gap between the hospital and post-discharge care

In This Issue Technology Watch

6

Patient telemonitoring helps hospitals maintain seamless post-discharge care.

Cindy Kuzendorf, PharmD discusses the rewards of preceptoring the nation’s only ASHPaccredited home infusion residency program.

Business Case Study

12

TPN Regimens In Hospital Causing Problems at Home

For Aralast, Limiting Distribution Helps Boost Drug Safety

Overfeeding triggers risky electrolyte imbalances post-discharge

Registries, monitoring plan help ensure optimal outcomes

O

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M

Q&A

10

Volume 1 • Number 1 • November 2011

Fight or switch?

One health-system’s strategy for becoming a specialty pharmacy contractor.

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•

•

Continuous vs. intermittent IV antibiotic dosing: why the disconnect between hospital and home?

Educational Review

14

Compatibility of Commonly Used Intravenous Drugs

Coding Consult POLICY WATCH

Joint Commission Eyes Stronger Oversight Of Specialty Pharmacy

A

Each issue will provide essential clinical and business information for stakeholders in specialty pharmacies, home infusion providers, insurers and managed care organizations.

see TPN REGIMENS, page 3

Clinical Controversies

13

see ARALAST, page 1

A new quarterly publication from the editors and publisher of Pharmacy Practice News.

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see COMMISSION, page 1

Top 10 Coding Mistakes—And How To Fix Them

G

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Our goal: to help foster high-quality, cost-effective treatment across the entire patientcare continuum.

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Bridging the gap between the hospital and post-discharge care

(Beginning in October 2012, hospitals with higher-than-expected 30-day readmission rates for heart failure, acute myocardial infarction and pneumonia will be subject to significantly reduced Medicare payments.)

The McKesson process begins with a thorough assessment. “Our pharmacy optimization consultants often work with multidisciplinary teams that include pharmacy and hospital administration, to help them assess their needs, determine a roadmap for development and frame out appropriate service lines,” Mr. Borr said. He added that transplant medicine, anticoagulation therapy and diabetes care are several areas in which patients require ongoing outpatient care and medication management.

At the heart of the portfolio is EnterpriseRx, a centrally hosted pharmacy management system that enables users to integrate and share information across the entire health system, including administration and physicians’ practices. EnterpriseRx also allows pharmacists to give discharged patients the option of enrolling in a program to receive their refills directly from the ambulatory pharmacy. The portfolio includes options for high-volume pharmacies (those dispensing up to 3,000 prescriptions per shift), such as the ExpressRx Track, an automated, high-speed, conveyor-based system.

Mr. Borr noted that the systems available within the Ambulatory Pharmacy Solution set are designed to help health systems that are just entering the ambulatory pharmacy arena, as well as those that already have an abulatory pharmacy presence. “The outpatient pharmacy automation solutions can particularly help pharmacies just starting to organize a cohesive physical space to manage and process the work, so people aren’t on top of each other or products are not in inconvenient places,” he said. “That’s going to save the pharmacists time that can then be directed to patient care including improved discharge medication capture rates, adherence and outcomes.”

He added that Pharmacy Central is another system within the portfolio that includes templates for a variety of pharmacy activities, including risk evaluation and mitigation strategies (REMS) for an assortment of conditions and drugs, monographs for formulary management, and other peer-reviewed content. The templates are customizable and designed to serve as a base on which to build. Overall, the portfolio offers purchasing and inventory solutions, retail solutions, claims-reimbursement and reconciliation services,

Pharmacy Practice News • February 2012

Operations & Management 17

Practice Models labor efficiency and medication-safety solutions and consulting services.

ExpressRx Track pharmacy automation, according to a McKesson representative.

Timing Is Everything

Build It or Buy It?

According to Steve Rough, MS, RPh, director of pharmacy at the University of Wisconsin Hospital and Clinics and clinical assistant professor at the University of Wisconsin–Madison School of Pharmacy, the sooner health systems incorporate ambulatory (e.g., outpatient, or retail) pharmacies into their care continuum, the better. “When you look at health reform, the initiatives from [Centers for Medicare & Medicaid Services on hospital readmissions] and value-based purchasing, now is the time for hospital leaders and health-system pharmacists to move forward with establishing comprehensive ambulatory pharmacy services which will improve the quality of care provided to patients, the patients’ experience with their care and the hospital’s financial performance,” he said. “Selecting a business partner to provide you with a state-of-the-art, efficient prescription processing software system and perhaps to assist you with establishing and maintaining these services may be necessary.”

Mr. Rough acknowledged that setting up an ambulatory pharmacy can be intimidating and a lot of work, especially for pharmacists whose career has been spent in the hospital inpatient setting.

“Many pharmacy directors aren’t initially excited about getting into the ambulatory pharmacy arena, but that’s where finding a business partner that has some experience in that area comes in,” he said.

Creating an ambulatory pharmacy is also logical from a clinical perspective, he added. “Inpatient pharmacists often teach patients about medications before discharge, and the hospital’s outpatient pharmacists can reinforce that teaching. By working as a team, inpatient and outpatient pharmacists can ensure the patients are taking the right drugs the right way, and help avoid readmissions.”

He noted the fierce competition for prescription dollars. “Chain stores are aggressively pushing to get into the hospital setting, selling [the concept] that their services will improve the efficiency and quality of care of the hospital’s patients upon discharge. Why let someone else come in and take a cut of your business?” he asked. “If you can bring in revenue, your hospital will have more capital to invest in staff, technology and infrastructure improvement. Achieving success in the ambulatory pharmacy environment is an opportunity for the director of pharmacy to become a hero in the eyes of hospital senior leadership and a visible advocate for doing what’s best for high-quality patient care and service.”

The University of Wisconsin Hospital and Clinics is an EnterpriseRx customer; however, they do not currently use

Ernest R. Anderson Jr., MS, RPh, system vice president of pharmacy, Steward Health Care System, in Boston, said there are several factors to consider when deciding whether to add or expand existing ambulatory pharmacy services—and whether to seek the help of companies such as McKesson in the process. One of the

•

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18 Operations & Management

Pharmacy Practice News • February 2012

Workflow

PHARM TECHS continued from page 1

drug therapy management activities,” according to the survey, which was presented at the ASHP Midyear Clinical Meeting by representatives from the ASHP Section of Inpatient Care Practitioners.

Efforts to achieve more widespread use of technicians have been in place for decades. “I’ve been a long-time believer in the potential role for technicians,” said Patricia Wegner, PharmD, vice president of professional services for the Illinois Council of HealthSystem Pharmacists (ICHP).

In 1990, Dr. Wegner was chair of the Commission on Technician Certi-

fication for ICHP, which was designing a statewide technician certification exam. Her counterparts in Michigan were doing the same for their state.

Collaboration between the two organizations and other stakeholders led to the establishment of the Pharmacy Technician Certification Exam (PTCE), the first nationally accredited certification exam for technicians, administered through the Pharmacy Technician Certification Board (PTCB). “Way back then, we recognized the importance of pharmacy technicians and the need to partner with them to advance the pharmacist’s role and use their cognitive skills to work with the health care team to improve patient care and outcomes,” she said.

Summary of Pharmacy Technician Survey Results

T

he results of two surveys regarding the role of pharmacy technicians in health systems were presented at the 2011 ASHP Midyear Clinical Meeting.

Here are some highlights of those surveys.

The following are from ASHP’s Section of Inpatient Care Practitioners Pharmacy Support Services Section Advisory Group Survey of Hospital Pharmacists (372 respondents): • 52% said they were aware of the recommendations of the PPMI related to pharmacy technicians.

• 92% agreed or strongly agreed with the PPMI statement, “Pharmacy technicians who have appropriate education, training, and credentials could be used much more extensively to free pharmacists from drug distribution activities.”

• 91% agreed or strongly agreed with the PPMI statement, “Assigning medication distribution tasks to pharmacy technicians would make it possible to redeploy pharmacists’ time to drug therapy management activities.”

• 94% agreed or strongly agreed with the PPMI recommendation that “ASHP should define a scope of practice, including core competencies, for hospital and health-system pharmacy technicians.”

• 83% agreed or strongly agreed with the PPMI recommendation “to support optimal pharmacy practice models, technicians must be certified by the Pharmacy Technician Certification Board.”

• 92% agreed or strongly agreed with the PPMI recommendation that “uniform national standards should apply to the education and training of pharmacy technicians.”

• 83% agreed or strongly agreed with the PPMI recommendation that “all distributive functions that do not require clinical judgment should be assigned to technicians.”

• 7% of organizations required completion of an ASHP-accredited technician training program when hiring technicians, 26% of organizations required completion of any pharmacy technician training program and 69% of organizations required a high school diploma.

• 93% of organizations allow technicians to inspect and replenish medication storage devices.

• 67% allow technicians to manage controlled substances systems.

• 24% allow technicians to check dispensing by other technicians.

The following are from ASHP’s 2011 National Survey of Pharmacy Practice in Hospital Settings (selected results related to pharmacy technicians; 562 respondents): • 22.2% of hospitals use pharmacy technicians in three or more nontraditional or advanced responsibilities or activities.

• 16.6% of hospitals use pharmacy systems exclusively to perform all traditional preparation and distribution activities.

• 3.6% of all hospitals allow remote video supervision of technicians involved in IV preparation activities, while 15.6% of hospitals with more than 600 beds allow this practice.

• The mean number of full-time equivalent technicians employed by hospitals was 10.2 in 2011, compared with 8.4 in 2002.

Since then, the number of technicians certified by PTCB has grown to represent nearly 80% of all technicians practicing in the United States.

Additionally, according to ASHP’s 2011 National Survey of Pharmacy Practice in Hospital Settings, 65.8% of technicians working in hospitals held a certification from the PTCB in 2011 compared with 58.4% in 2009.

Commenting on ASHP’s National Survey findings, Megan Sheehan, PharmD, PTCB’s director of professional affairs, noted that the board is “pleased to see” that the findings “show that rates for pharmacy technician certification and graduation from accredited education programs continue to increase. This growth is consistent with the profession’s move to an improved practice model, where pharmacy technicians are well prepared to fulfill drug preparation and distribution functions, allowing pharmacists more time to dedicate to direct patient care activities.”

Dr. Sheehan noted that PTCB is “conducting a job analysis study to collect information about the work of pharmacy technicians, which will be used to update the blueprint for the [PTCE].”

More than 20,000 certified pharmacy technicians participated in the study, according to Dr. Sheehan, and the results are expected to be available in August 2012.

PPMI Summit Underscores Importance of Technicians The ASHP, too, has long advocated enhanced certification and training and a more expansive role for technicians. ASHP’s ambitions were codified during the 2010 Pharmacy Practice Model Initiative (PPMI) Summit in Dallas, which produced a stout list of goals and recommendations advocating better and more consistent training, as well as uniform standards of education and preparation, for pharmacy technicians. However, although ASHP survey results show respectable progress toward meeting most PPMI goals, there’s still a long way to go, said Trey Wynn, RPh, MBA, MHA, current member and two-time chair of the Pharmacy Support Services Section Advisory Group. “What really stands out is that more technicians have not completed an ASHP-accredited program,” said Mr. Wynn, who has taught

at an ASHP-accredited college program for technicians. According to ASHP’s 2011 National Survey, as of that year, 11.1% of technicians had completed an ASHP-accredited technician training program. “Ideally, I would like to see technicians in every state trained to the point that they are competent enough to check any nonclinical work by a pharmacist or another technician,” said Mr. Wynn. “I would be happy for a technician to catch a mistake I made. This would strengthen the case for allowing the technician to do all nonclinical functions.”

Mr. Wynn favors a national standard for technician training requirements in addition to individual state prerequisites and in addition to PTCB certification. “My focus is on safety,” he continued. “If technicians are licensed and certified, that doesn’t mean that they won’t make a mistake, but they should have the understanding and depth of knowledge that will help them to determine what’s most important in their work.”

Some of the many nontraditional roles that technicians are taking on include medication reconciliation; checking dispensing of other technicians (techcheck-tech); collecting laboratory value data for pharmacist review and action in general medicine, oncology clinics and anticoagulation clinics; conducting quality assurance audits; and reconciling and tracking narcotics taken from automated dispensing systems. State board of pharmacy rules often dictate the limitations on how far a technician’s work can extend, and Dr. Wegner emphasized that the assignments must be well matched to a technician’s skill and training.

“We’re not advocating these higher roles for technicians who have not gone through the proper education and training,” she said. “That’s why we feel it’s so important for those who are interested in more advanced work to complete a nationally accredited training program and pass the PTCB examination. We know that if they complete the educational program and pass the exam, they have achieved a certain level of understanding.” In her state, Illinois, technicians must become certified by successfully passing the PTCB examination or another board-approved pharmacy technician

•

see PHARM TECHS, page 24

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20 Operations & Management

Pharmacy Practice News • February 2012

Finance

FISCAL STARS

the floor under high stress. Now, they’re ready to go.”

continued from page 1

Offsite IV Prep Yields Savings More efficient medication use also led to financial gain at the 838-bed Charleston Area Medical Center in Charleston, W.Va., which acquired a cen-

Another Pullback From Outsourcing

15

Savings, $ (millions)

stimulating agents (ESAs) used in the hospital’s outpatient hemodialysis clinic (poster 3-112).

In spring 2010, the 555-bed hospital reverted to using epoetin alfa (Epogen, Amgen; Procrit, Janssen) as its sole ESA for clinic patients, rather than darbepoetin alfa (Aranesp, Amgen). Why the switch? Although the institution had adopted darbepoetin alfa a decade ago, it never fully realized the savings promised by the drug’s manufacturer, according to Justin Gamble, PharmD, clinical coordinator of pharmacy services.

In determining the optimal conversion ratio for the ESAs, Dr. Gamble and his colleagues first turned to the drug labeling for darbepoetin alfa. According to the label, 400 units of epoetin alfa is equivalent to 1 mcg of darbepoetin alfa, for a 400:1 ratio. But the label also states that a 254:1 ratio could be used when switching to darbepoetin alfa. Dr. Gamble and his colleagues believed they could use a lower ratio, but they couldn’t find definitive data on a safe and effective ratio now that they were going in the opposite direction, back to epoetin alfa.

“We were confident that it would be less than 400:1, but we didn’t know how much less,” Dr. Gamble said. A literature search turned up scant information—mostly case reports and anecdotal evidence—about acceptable conversion ratios. Some reports cited ratios as low as 200:1. One thing Dr. Gamble did know was that the clinic’s break-even point for drug cost would be around 320:1.

A retrospective chart review of 146 clinic patients found a mean conversion ratio of 225:1, which consistently held hemoglobin levels within a target range of 10 to 12 g/dL. The variation for individual patients ranged from 63:1 to 382:1, and higher ESA doses generally resulted in higher conversion ratios. “It’s important to note that there is tremendous interpatient variability, so this ratio serves as a starting point in our dialysis unit. The ratio will need to change as we begin targeting lower hemoglobin levels,” Dr. Gamble said.

Within one year of the conversion to epoetin alfa, the dialysis unit had realized approximately $300,000 in savings.

Dr. Gamble added that drug company rebates brought the effective savings closer to $500,000. “Any dialysis unit or hospital that is considering making this switch should evaluate their use of these agents to determine if it makes sense in their setting,” he said.

10

13.5

8.0

5

0

3.8

1 year (projected)

3 months (actual)

1 year (actual)

Figure. Savings from internal drug replacement program, Harris County Hospital District.

‘As finances become tighter, hospitals are being asked to do more with less. That often means finding unique solutions in order to work smarter.’

—Jennifer Brandt, PharmD trally located offsite IV compounding facility in November 2007 (poster 3-007).

To prepare for the change and create a baseline for its expected economic impact, the hospital compiled cost and dispensing information for compounded sterile preparations (CSPs) purchased through outside pharmacies and vendors. It also arranged for facility inspections and licensure by the state board of pharmacy and recruited six pharmacy technicians and 2.4 full-time equivalent (FTE) pharmacist positions.

The transition to total reliance on the new facility progressed in steps, with the gradual addition of capabilities for cardioplegia, electrolyte minibags, antibiotics, various prefilled syringes and various critical infusions, such as amiodarone, epinephrine, norepinephrine and phenylephrine.

During the first full month of operation, the facility produced 1,758 CSPs; it now averages 24,000 CSPs monthly.

Batch-prepared drips and IV medications have shortened turnaround times

for these drugs, according to Brian Sayre, PharmD, health-system director for pharmacy and drug information at Comprehensive Pharmacy Services, which manages pharmacy operations for the hospital. Additional efficiency and improved response times resulted from the ability to load many of the compounded drugs into automated dispensing cabinets in the intensive care units, and drug expenses have decreased by $2,042,941, Dr. Sayre noted. After accounting for the costs of the additional staff and other expenses, net annual expenditures still had decreased by $1,092,611.

“We plan to keep expanding,” Dr. Sayre said. “For many of the compounded drugs, we’ve conducted in-house stability studies that have enabled us to extend dating. In addition, when pharmacists respond to a Code situation, which is standard procedure at the hospital, they can grab premixed drips for amiodarone, epinephrine and norepinephrine, which greatly improves safety by eliminating the need to mix those compounds on

Another instance of internalizing a previously outsourced function led to millions in savings for a county health system that serves many indigent patients (poster 5-075). Harris County is the third most populous county in Texas, and more than 27% of its residents are uninsured.

Because Texas law requires counties to treat those in need, many residents rely on the Harris County Hospital District (HCHD) for their health care. The pharmacy department had contracted an outside vendor to conduct drug-replacement activities to recover drugs given to all HCHD patients enrolled in patient assistance programs (PAPs). However, collections had steadily trended downward to 40% of what they once were.

“We saw there wasn’t a lot of effort put into collections,” said Uche Anadu Ndefo, PharmD, BCPS, a drug information specialist for the HCHD who assisted with the project. “We also realized that what we paid the vendor was too generous, so they didn’t have the incentive to aggressively go after collections.”

The formulary management and pharmacoeconomics team was confident the job could be better performed internally. The hospital’s administration agreed after being shown the potential savings. The internal drug replacement program rolled out in December 2010 and was staffed by 13 FTEs, including a pharmacy services manager, a senior drug-replacement analyst and 11 drug replacement analysts. They immediately pursued all unused drugs approved by the institutional patient assistance program (IPAP) and PAPs and which had been dispensed by HCHD pharmacies.

The program leaders had projected that the health system would save $8 million annually. Instead, within three months HCHD saved nearly $3.8 million and had been reinstated into three major manufacturers’ IPAPs. By November 2011, at the one-year point of the study, savings hit $13.5 million (Figure). “The program more than pays for itself, and we just got five more FTEs approved to start next year,” Dr. Ndefo said.

Reconstituting Bivalirudin A Prescription for Savings Jenna Minton Huggins, PharmD, BCPS, clinical coordinator in the Cardi­ olo­gy Department of Pharmacy at the 870-bed WakeMed Health in Raleigh, N.C., noticed wasteful use of bivalirudin (Angiomax, The Medicines Company), a costly anticoagulant for use during percutaneous coronary intervention (PCI) procedures. Typically, the 250-mg vials supplied by the manufacturer were reconstituted into 50-mL admixtures.

Pharmacy Practice News • February 2012

Operations & Management 21

Finance Dr. Huggins and her colleague, J. Erin Allender, PharmD, BCPS, a cardiology critical care clinical specialist, envisioned a straightforward way to use the drug more efficiently (poster 5-045).

They found that the majority of the cath lab PCIs lasted 20 to 30 minutes, creating the potential for more than 25 to 30 mL of the drug to be left afterward. “We were wasting 20 mL of a very expensive medication. In fact, it’s the most expensive medication that we use in the cath lab,” Dr. Huggins said.

Why not repackage the reconstituted bivalirudin into two 25-mL aliquots?

That’s just what they did, using aseptic technique and a laminar flow hood in the pharmacy IV room. The new aliquot process was implemented in November 2010. To reach their primary end point, the researchers compared bivalirudin excess before and after implementation of the new strategy, and then compared costs. The median excess bivalirudin in the pre-aliquot cohort was 24 mL, while the median excess in the post-aliquot group was 18 mL; the estimated annual savings came to $84,000.

Although far more were eligible, only 13% of patients received the 25-mL aliquot, according to the researchers. If use of the smaller aliquot were expanded to 65% of eligible patients, annual savings could jump to $268,000.

Additionally, a relatively high number of cases required 25 to 28 mL of the drug, so producing a 30-mL aliquot could increase the number of aliquoteligible patients by another 20%.

(The low percentage of patients receiving the 25-mL aliquot was attributable to the fact that the cath lab staff had not been fully educated to consider the relatively large amount of medication that was still in the infusion line before they used another aliquot, Dr. Huggins noted. She added that she provides regular briefings to increase awareness among the staff.)

Partnering With Dieticians In the case of the 908-bed Washington Hospital Center in Washington, D.C., wasteful medication use was curtailed—while pharmacist intervention simultaneously increased—through a collaboration between pharmacists and dietitians (poster 5-059).

Following bowel surgery, alvimopan (Entereg, Adolor) is used to speed the recovery of bowel function. But the expensive drug is no longer needed once patients return to an oral diet.

Nevertheless, Jennifer Brandt, PharmD, a clinical pharmacist at the hospital, found that postsurgical patients frequently received the drug after they had begun eating again. To avoid such misuse of the drug, dietitians at the hospital now identify when patients return to an oral diet and compare the informa-

tion with a daily report generated by the pharmacy’s computer order entry system. It’s part of a larger system developed to identify all patients who had received one of 10 drugs for which the hospital has approved automatic IV to oral therapeutic interchanges.

“We found that some patients were being continued on alvimopan unnecessarily after their bowel function returned,” Dr. Brandt said. “After the patients begin an oral diet, dietitians now notify the pharmacy and we can follow up and cut back on the use of the drug.”

After the new alvimopan oversight procedures were implemented in November 2010, the average number of alvimopan doses per patient dropped from eight to six, equating to cost savings of $40,000 over six months. The collaboration led to other benefits as well: “The process saves time because the pharmacist doesn’t have to search through charts or nurses’ notes to determine a patient’s dietary status,” Dr. Brandt added.

With budgets squeezed and clinicians being asked to justify any undertaking that involves increased staff or

expenditure, initiatives like those cited here, along with countless others focused on the bottom line, are becoming the norm. “As finances become tighter, hospitals are being asked to do more with less,” Dr. Brandt said. “That often means finding unique solutions in order to work smarter.”

—Steve Frandzel Drs. Gamble, Ndefo, Huggins, Allender and Brandt, and Mr. Wynn, reported no conflicts of interest. Dr. Sayre is an employee of Comprehensive Pharmacy Services.

22 Operations & Management

Pharmacy Practice News • February 2012

Finance

Reducing IV Waste Saves Time and Money New Orleans—The financial and ecological impact of waste from IV medications is a significant problem at many hospitals. Donna Hausermann, PharmD, the inpatient pharmacist for the Cincinnati Veterans Affairs (VA) Medical Center in Ohio, understands the subject well.

Dr. Hausermann, who worked as an IV technician for 12 years, presented a poster detailing her IV waste project at

the American Society of Health-System Pharmacists’ (ASHP) Midyear Clinical Meeting. “The topic of IV waste is near and dear to my heart,” said Dr. Hausermann. “I knew firsthand how much it needed to be addressed.”

Dr. Hausermann collected data during a recent three-month study to quantify the total amount of waste from IV products—particularly waste resulting from discontinued or changed medica-

tion orders. Her primary research goal was to assess the rate at which unused IVs are returned to the pharmacy, and to evaluate the economic impact of the waste that results from those returns.

Her study showed that the Cincinnati VA had an opportunity to reduce costs by almost $300 per day by improving IV room processes.

The waste was attributable to several factors, Dr. Hausermann noted, includ-

ing compounding medications and preparing doses for distribution too far in advance of patients’ scheduled doses, waiting too long to distribute doses to nurses, and not retrieving unused IV medications before they expired. These problems led to thousands of dollars’ worth of waste each year from discarded and expired IV medications.

Identify the Problem— And Then Fix It The study also was designed to develop a system to reduce the amount of IV waste, and in turn lower hospital costs.

The main components of the system were as follows: Dose preparation. “We were compounding and labeling IVs just once a day, independently of when doctors

‘Everyone is happier with the [IV drug] distribution process, and there’s the added benefit of knowing we’re not unnecessarily wasting drugs.’

—Donna Hausermann, PharmD were ordering or changing medications.

But doctors usually write orders just before or after morning rounds, so we weren’t capturing those changes. Now we do it twice daily. That allows us to capture more of the dosing changes, additions and deletions.”

Improving distribution. “Before the changes, we’d distribute IVs close to when doses were due. Now we try to have them in nurses’ hands two hours prior to administration, so the nurses don’t reorder doses because they’re nervous about not receiving them in time.”

IV retrieval. “In the past, no one was designated to pull IVs from the hospital wards or delivery stock. If an order was changed or a product returned unused, it was left in no man’s land until the next morning. By then it would have expired and we couldn’t use it. So we installed an active retrieval process. Now a pharmacy technician retrieves discontinued products and gets them back into the pharmacy for reuse.”

These interventions led to a decrease in the cost of IV waste from $299 to $88 a day on average, and the percentage of IVs wasted each day dropped by 20%, Dr. Hausermann reported. The total annual cost of IV waste fell by 71% from $107,648 to $31,954. The IV medications that were reduced were almost exclusively antibiotics, she noted, particularly β-lactams, accounting for 51% of overall

Pharmacy Practice News • February 2012

Operations & Management 23

Finance IV waste. The reduction also included cardiac agents, electrolytes, heparin and other common IV medications.

Another Approach: Focus on High-Ticket Drugs, Par Levels St. Rita’s Medical Center, a 450-bed, Level II trauma center in Lima, Ohio, has been similarly successful in reducing IV waste. As with the Cincinnati VA, the greatest amount of IV waste was created by pharmacy technicians compounding medications far in advance of patients’ scheduled doses. Waste created when doctors discontinue IVs, discharge patients or change medication doses was costing St. Rita’s more than $140,000 a year, according to Nancy L. Rampe, PharmD, the hospital’s pharmacy department supervisor.

Dr. Rampe took on the challenge of reducing IV waste, and within a year the hospital saved more than $65,000.

She doubled the number of medication batches from three to six per day, which greatly cut costs, and also identified two other important areas where the hospital could save money: reducing the waste of expensive medications and reconsidering par levels.

Dr. Rampe said that about half of the IV waste could be attributed to a handful of high-cost medications, including the antibiotics caspofungin acetate (Cancidas, Merck), daptomycin (Cubicin, Cubist) and tigecycline (Tygacil, Pfizer), and the heart failure medication nesiritide. To build awareness of cost as an important factor in patient care, Dr. Rampe posted a list of the 25 most expensive IV medications in the pharmacy. “It makes the technicians more cognizant of the costs, and more likely to wait until they know the patient still needs the expensive medications before preparing them,” she explained.

To solve the problem of these pricey medications getting “lost” and taken to the wrong nursing station, the hospital began delivering them through the tube system via secure transaction. Under the new system, the only way a nurse can retrieve the medication is to input a code.

Dr. Rampe also lowered the hospitals’ par level (the number of doses it keeps on the shelf ready to go) of piperacillin and tazobactam for injection (Zosyn, Pfizer), which resulted in additional savings. When Dr. Rampe realized a significant number of the medication doses were expiring, the staff began gradually reducing the par level until it reached an acceptable amount, where fewer doses were expiring, and staff members didn’t have to make extra doses during their shifts.

Break Out the Chocolate Employees of the Cincinnati VA’s pharmacy celebrated their success with a chocolate party. But the sweetest treat

for the team, Dr. Hausermann said, is the satisfaction of a job well done. “Everyone is happier with the distribution

process, and there’s the added benefit of knowing we’re not unnecessarily wasting drugs,” he noted. “Now everyone is

asking: ‘How else can we save money?’”

—Dana Hawkins-Simons

24 Operations & Management

Pharmacy Practice News • February 2012

Workflow

PHARM TECHS continued from page 18

examination within two years of registration. But many states, she added, require nothing more than a high school diploma and a registration fee to work as a technician.

One important barrier to widespread accreditation, according to Dr. Wegner, is a dearth of training programs. “There aren’t enough facilities that provide ASHP-accredited training. Until that becomes a mandate, you won’t find schools that offer that,” she said. In the absence of any national FILEstandard SLUG designating a minimum level of trainCMEzone qtrpg.indd 1ST PROOF LAYOUT APPROVED INITIALS AND DATE MAX sign-off

SOLUTIONS

Senior Editor

continued from page 17

R2

Copy Editor Sales

main considerations, Mr. Anderson February 1, 2012 12:44 PM Production noted, is the size of your potential Creative on outpatient customer base. “Margins pharmacy drugs are very tight—as low COMMENTS: Half Vertical as two to three percent,” he said. “You 4C really need to have a healthy volume of patients who not only are willing to fill their initial prescription at discharge, but also come back for refills, to make

ing for technicians, it’s left up to the state organizations to push for more stringent and uniform requirements related to technician practice, and to push state boards of pharmacy to require licensure—not just a registration—to practice.

Sylvia Banzon, CPhT, CQiA, PMP, regional quality coordinator with Sutter Health in Sacramento, Calif., is heartened by the survey results, which show a strong buy-in to the notion of technicians as key members of the pharmacy staff. “It’s goodPROOF to 1 see there’s 12/10 FINAL OK INITIALS AND DATE

REV 1 12/17 REV 2 REV 3 4 those margins make senseREVfinancially.”

REV 5 Such a base of patients is easier to REV 6 reach, he noted, if yourREVhospital has 7 many clinics onsite or in the REV 8 community, where patients find it convenient to get REV 9

been a shift on that, but there’s still work we need to do,” she said. Ms. Banzon has been a pharmacy technician for nearly 25 years, 10 of them as a pharmacy technician supervisor, and she has been certified since 1996.

“Institutions have to grow and develop their technicians,” Ms. Banzon said. Describing her experience at Sutter Health, she said, “We did a lot of training here when we decided to create the position of clinical pharSTATUS AND HISTORY macy technician, which requires not PICKED UP FROM:

only certification, but also five years of experience.” Clinical technicians at her hospital assist pharmacists with IVPO (IV to oral) conversions; perform quality assurance audits and inventory management (which is particularly important in light of drug shortages and recalls); and train all staff in order entry, policies and procedures and pharmacy technology.

“Health-system pharmacists want to do a lot more direct patient care,” Ms. Banzon added, “but for that to happen, they’ll have to rely on technicians to run the operations of the pharmacy.”

—Steve Frandzel

APPLIED TO:

Practice Models

care for chronic diseases and also get their prescriptions filled.

As for whether to partner with McKes­ son, “they certainly have expertise in a wide range of pharmacy operations,” Mr. Anderson said. “I’ve worked with them in the initial stages of a project to boost

our use of 340B medications, prior to our becoming a for-profit entity, and I was very impressed with their industry knowledge.”

Recent studies support the idea that outpatient pharmacy services can yield major benefits. By involving pharmacists in the clinical oversight of outpatient parenteral antimicrobial therapy (OPAT), for example, the University of California, Davis Health System was able to avoid hospital discharge delays for 35 patients,

which yielded approximately $366,000 in cost savings for the year of the study (Ann Pharmacother 2011;45:1329-1337).

Moreover, the unnecessary use of OPAT was avoided in 75 cases (13.2%), and central venous catheter placement was avoided in 48 referrals (8.4%), resulting in $58,080 in additional savings (Pharmacy Practice News, January 2012, page 29).

—Terri D’Arrigo, with additional reporting by David Bronstein

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Corporal Greg Caron McMahon Publishing, the publisher of this newspaper, is sponsoring a fundraiser for Cpl. Greg Caron.

Cpl. Caron is an Ellington, Conn. Marine. He was injured in November in the line of duty after stepping on an IED in Afghanistan. He lost both of his legs and a finger, and also broke his collarbone. We are raising funds to help Greg and his family as they face a very long recovery.

If you would like to help, please visit www.gregcaronfoundation.com.

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Please note, contributions to this fund are not tax-deductible.

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Hem/Onc Pharmacy 25

Pharmacy Practice News • February 2012

In Focus

METHOTREXATE continued from page 1

interactions there are,” said Ali McBride, PharmD, clinical pharmacy specialist at the Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital in St. Louis.

In addition to PPIs, other drugs that can delay the elimination of methotrexate from the body, potentially with toxic consequences, include: • Nonsteroidal anti-inflammatory drugs (NSAIDs) • Salicylic acid (aspirin) • Many antibiotics, including penicillin, vancomycin and amoxicillin “We’ve had several cases of methotrexate toxicities in our setting,” Dr. McBride said. “We treat a lot of acute leukemic patients, and also lymphoma patients who require high-dose methotrexate. With this drug, in oncology, we use a high dose, it gets into the cell, and then we use leucovorin to rescue the cells that aren’t replicating as quickly as the cancer cells. In that protocol, you have to maintain the patient’s urine pH at greater than 7.0 in order to maximize the elimination of the drug and prevent any toxic side effects.” But patients taking PPIs, NSAIDs, antibiotics and/or aspirin may have a difficult time maintaining that pH, he noted.

The signs of acute methotrexate toxicity can include the following: • Severe vomiting, diarrhea, or mucositis • Low white cell count • Low blood platelets • Renal failure Although the potential for a toxic interaction may be more significant with the high doses of methotrexate used in chemotherapy, these risks are still present with the low doses of the drug used to treat RA—but they are likely to be less well understood, experts note.

“Patients with rheumatoid arthritis are also commonly taking NSAIDs as well,” said Robert Ignoffo, PharmD, FASHP, FCSHP, clinical professor emeritus at the University of California, San Francisco and professor of pharmacy at Touro University College of Pharmacy in Vallejo, Calif. “And if you’re taking an NSAID, you may also be taking a PPI because you have GI [gastrointestinal] side effects from the NSAIDs. So you have a double whammy—the NSAID and the PPI both interact with the methotrexate to delay its elimination.”

Although these drugs also may be prescribed concomitantly for cancer patients, the interaction is less likely to be missed, Dr. Ignoffo noted. “It’s highly unusual to see someone getting high-dose methotrexate and an NSAID, because it’s an oncology unit overseeing the administration. Up until the FDA alert, however, they would have

‘There are case reports where someone taking a low dose of methotrexate for rheumatoid arthritis has signs of toxicity even with only two to four weeks of NSAIDs.’ —Ali McBride, PharmD

“The ability to get carboxy within 24 hours is an issue,” he noted, adding that because it’s experimental, permission to use it must be obtained from the FDA. “If your institution is in California, it’s going to take 12 hours to get to you,” Dr. Ignoffo said. “That may be too late. But even without that, there are a number of costly complications. If the interaction results in extreme myelosuppression, then the patient has to be hospitalized, given broad-spectrum antibiotics and monitored for at least a week. That’s costly to the system and unnecessary for the patient.”

Help at Hand

‘The warning should go out to all oncologists, oncology pharmacists and nurses, as well as rheumatology [specialists]: These drugs should be put on the checklist of red-flag items prior to the administration of methotrexate in any form.’

—Robert J. Ignoffo, PharmD

been less familiar with the PPI interaction, so I think the FDA is on the mark here in issuing it.”

The dose and duration of methotrexate therapy that trigger toxic drug interactions have yet to be determined, according to Dr. McBride. “That’s the question everyone is still trying to figure out,” he said. “There are case reports where someone taking a low dose of methotrexate for rheumatoid arthritis has signs of toxicity even with only two to four weeks of NSAIDs.” Until such questions are resolved, experts recommend a high degree of caution when prescribing the drug

combinations—not just for the patient’s safety, but in order to avoid the high cost of complications.

“We had a patient taking methotrexate who was on a PPI and had delayed elimination. He had low platelets and acute renal failure and had a seizure, and ended up in the hospital for 33 days,” Dr. McBride said. “We had to use an investigational drug, carboxypeptidase G2, which costs tens of thousands of dollars. If someone had caught this early on and changed the drug, we could have prevented this interaction.”

Barnes-Jewish was lucky to get the rescue drug in time, Dr. Ignoffo added.

Fortunately, getting access to the rescue drug, also known as glucarpidase, may soon get easier. On Jan. 17, the FDA approved the medication (Voraxaze, BTG plc) for the treatment of toxic plasma methotrexate concentrations in patients with delayed methotrexate clearance due to impaired renal function. Although it will likely be a few months before the drug is available commercially, the approval “represents a significant gain in the limited arsenal for treating methotrexate toxicity,” said Leigh Boehmer, PharmD, BCOP, also clinical pharmacist in medical oncology at Barnes-Jewish.

Dr. Ignoffo said he wouldn’t be surprised if pharmacists and prescribing physicians were missing methotrexate interactions at least 10% of the time. “It may go unnoticed if the patient doesn’t have an extreme reaction,” he said.

Moreover, drug–drug interactions may not be the only problem with methotrexate therapy. Anything that increases the acidity of urine may impair elimination of the drug—such as carbonated beverages. A 2010 case report in the British Journal of Clinical Pharmacology (2010;70:762-764) found that unexplained low urinary pH in a lymphoma patient being treated with high-dose methotrexate was resolved in part by the elimination of cola drinks from the patient’s diet.

In St. Louis, Dr. McBride had a similar experience. “We had a patient who was set to begin a regimen for acute lymphocytic leukemia that included methotrexate, but we couldn’t get this patient’s pH within range to start the treatment. It turned out that he was constantly drinking those huge containers of Pepsi that you get at the 7-Eleven.

We told him to switch to water; he did, and his pH levels resolved.”

Dr. Ignoffo added, “The warning should go out to all oncologists, oncology pharmacists and nurses, as well as rheumatology [specialists]: These drugs should be put on the checklist of red-flag items prior to the administration of methotrexate in any form.”

—Gina Shaw

26 Policy

Pharmacy Practice News • February 2012

Reimbursement Matters

Knowing 2012 Rules Changes: Your Key to Fiscal Health I

t’s a new year—and that must mean change is in the air, particularly for the Centers for Medicare & Medicaid Services (CMS) and the agency’s rules and regulations. Just as you were getting familiar with last year’s modifications to the system, new requirements are headed your way. It’s not something you can put off—health plans and HMOs follow Medicare’s lead for reimbursement, and ignoring reimbursement issues leads to financial ruin and possible investigations or audits.

Some basic information on reimbursement and several changes to the rules for 2012 are outlined in this article.

How Does Pharmaceutical Reimbursement Work?

The Medicare program as administered by CMS has three parts: A, B and D. Part A covers hospital inpatient and outpatient services, nursing home care, home health care and hospice care. Hospital outpatient services within Part A are administered through the Outpatient Prospective Payment System (OPPS).

Reimbursement for covered medications falls into Part B, as do physician services, medical supplies (e.g., durable medical equipment) and end-stage renal disease (ESRD) services. Outpatient prescription drugs, covered within the Medicare Prescription Drug Program, fall into Part D. In terms of reimbursement rules, the physician’s office (Medicare Modernization Act) is different from the hospital outpatient clinic (OPPS), and each of these is different from the hospital inpatient setting (inpatient prospective payment system or IPPS). Various coding options exist for each practice site, and prior authorization is required in some cases. (We’ll cover this in subsequent articles.)

Part B reimbursable drugs and biological products are handled by CMS through OPPS in one of four ways (Figure). In 2012, new drugs for which a Healthcare Common Procedure Coding System (HCPCS) code has not yet been assigned are reimbursed at 95% of average wholesale price. Pass-through payments may be available for new drugs and biologicals, and the basis for these payments is the average sales price (ASP) plus 6%, or the wholesale acquisition cost plus 6%, until enough ASP data are available. It’s imperative to monitor and act on routine quarterly updates that may change this (http://www.cms.hhs. gov/MLNMattersArticles/downloads).

Products losing 2012 pass-through status are listed in the Table on this page; a PDF of the table for printing (No.

32 in the PDF) can be accessed at www.pharmacypracticenews.com/CodeChanges.

The PDF also contains a table of drugs acquiring pass-through status (No. 33 in the PDF).

If 2012 daily costs of specified covered outpatient drugs exceed the threshold of $75, those administered in the hospital outpatient setting are reimbursed at ASP plus 4%; those given in the physician office setting are reimbursed at ASP plus 6%.

Daily drug costs falling below $75 are bundled into the payment for the ambulatory payment classification ( A P C ) , a s a re d r u g s f o r E S R D patients and contrast media. Think about how

to recoup these dollars with internal accounting transfers.

ASP Drug-Pricing Files CMS publishes quarterly ASP drugpricing files and provides links to the actual listing of reimbursable Part B drugs, the amounts that will be reimbursed, the billing units for each drug code, and the National Drug Code (NDC) Directory for each code.

Ambulatory surgery centers are subject to the same payment rates as physicians’ offices for any drug that is separately payable in the hospital outpatient area. However, to qualify for payment in this setting, the drug must be administered immediately before, during or after a procedure that is approved in this setting and must be billed on the same claim and date as the procedure itself.

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

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

Bonnie Kirschenbaum, MS, FASHP

Know Your Billing Units CMS no longer uses vial sizes to structure reimbursement tables; instead, they now reimburse based on the actual dose given, using billing units. Medicaid also uses billing units, although they’re not necessarily the same ones as used by Medicare. Despite the gallons of ink spilled in the pharmacy literature on this

Table. Drugs and Biologicals for Which Pass-through Status Expired December 31, 2011 CY 2012 HCPCS Code

CY 2012 Long Descriptor

Proposed CY 2012 SI

Proposed CY 2012 APC

J0598

Injection, C–1 esterase inhibitor (human), Cinryze, 10 units

K

9251

J0641

Injection, levoleucovorin calcium, 0.5 mg

K

1236

J0718

Injection, certolizumab pegol, 1 mg

K

9249

J1680

Injection, human fibrinogen concentrate, 100 mg

K

1290

J2426

Injection, paliperidone palmitate, 1 mg

K

9255

J2562

Injection, plerixafor, 1 mg

K

9252

J7312

Injection, dexamethasone intravitreal implant, 0.1 mg

K

9256

J8705

Topotecan, oral, 0.25 mg

K

1238

J9155

Injection, degarelix, 1 mg

K

1296

J9328

Injection, temozolomide, 1 mg

K

9253

Q0138

Injection, ferumoxytol, for treatment of iron deficiency anemia, 1 mg

APC, Ambulatory Payment Classification; CY, calendar year; HCPCS, Healthcare Common Procedure Coding System; SI, status indicator

New Drugs Not Yet Assigned Unique HCPCS Code

New Pass-through Drugs

Specified Covered Outpatient Drugs (SCODs) costing >$75/day

Lower-cost Packaged Products Costing <$75/day

Figure. Proposed OPPS 2012: Drugs and Biologicals Reimbursed in 1 of 4 ways.

ASP, average sales price; AWP, average wholesale price; HCPCS, Healthcare Common Procedure Coding System; OPPS, Outpatient Prospective Payment System; WAC, wholesale acquisition cost a

Aloxi (Eisai)

Pharmacy Practice News • February 2012

Policy 27

Reimbursement Matters

Resource Box

I

n addition to numerous reimbursement updates available on the CMS Web site (www.cms.gov), the American Society of Health-System Pharmacists (www.ashp.org), the American Pharmacists Association (www.aphanet.org) and the Association of Community Cancer Centers (http://www.accc-cancer.org/ OPENSITE/default.php) offer a wealth of information on their sites.

Also take a careful look at the documents below, all of which contain information that can help you stay abreast of key factors affecting payment rates. The documents can be accessed by scanning the QR codes on your smartphone or by entering the URLs in your computer’s browser.

topic, it’s still a tough policy to implement. Since billing unit tables can change with some frequency, pharmacy directors and information technology specialists who program pharmacy computers and automated dispensing systems must keep constant watch to ensure that billing units are correctly matched with HCPCS codes in the pharmacy charge description master. And don’t forget the NDC Directory, which also has changes that must be incorporated into your billing if you hope to avoid undercharges, overcharges and a complicated audit.

Ideally, you will be able to smoothly translate the doses and dispensable quantities within your pharmacy IV room or automated dispensing cabinets into a billable quantity under HCPCS. How best to do that?

Some facilities have built and maintain conversion tables, either by going through the pharmacy system if it supports this function, by using a lookup table with conversion logic in the translator outbound to the financial system or by building a multiplier table on the back end of the financial system. This multiplier table takes the number of units sent from the transaction and multiplies it by the appropriate factor without affecting the price. Dubbed “crosswalks,” they can bridge the gap between the description of a drug in the Drug Master File that you use when ordering entries into your computer system, and the related description in the CMS system. It pro-

OPPS Final Rule.

URL: www.pharmacypracticenews. com/GovOPPS

ASP files.

URL: www.pharmacypracticenews. com/GovASP

PFS Final Rule.

URL: www.pharmacypracticenews. com/GovPFS

vides an automatic conversion from one to the other in order to guarantee the accuracy of the number of units being billed, rather than leaving it to the discretion of the order entry person.

There’s no getting around the fact that there will always be a need for ongoing maintenance to keep your pharmacy Charge Description Master, HCPCS codes and NDC changes in sync. It’s

imperative that you and your charge capture team have a robust strategy to handle these changes.

Keep an Eye on Code Changes In addition to publishing quarterly updates in payment rates, CMS also may routinely change HCPCS codes. This requires vigilance on part of the pharmacy, the billing department, or both, so that you can quickly implement changes

and keep rebilling to a minimum.

Drug Administration APCs Whether a specific drug is reimbursed under one of the four methods of payment in the Figure, the actual administration of a drug can still be covered, using varying codes depending on the circumstances. This squint-inducing set of specifications requires the attention to detail of a fine watchmaker in order to ensure that the correct codes are being used for the administration of each drug—including those that are packaged into a procedure code. Be sure that administration of drugs is appropriately documented—including hang time, rate changes and end of infusion or “downtime.” The pharmacy and clinic setting must also keep their records coordinated in order to receive full payment.

(For more details on coding changes, see Table 33 in the PDF at www.pharmacypracticenews.com/CodeChanges.)

Services included in the Current Procedural Terminology codes for drug administration are: • Use of local anesthesia • Starting the IV • Access to IV, catheter or port • Routine tubing, syringe and supplies • Preparation of drug • Flushing at completion • Hydration fluid Think about how to recoup some of these monies with internal accounting transfers.

THIS MONTH Bridging the gap between the hospital and post-discharge care

In This Issue Technology Watch

6

Patient telemonitoring helps hospitals maintain seamless post-discharge care.

Cindy Kuzendorf, PharmD discusses the rewards of preceptoring the nation’s only ASHPaccredited home infusion residency program.

Business Case Study

12

TPN Regimens In Hospital Causing Problems at Home

For Aralast, Limiting Distribution Helps Boost Drug Safety

Overfeeding triggers risky electrolyte imbalances post-discharge

Registries, monitoring plan help ensure optimal outcomes

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Q&A

10

Volume 1 • Number 1 • November 2011

Fight or switch?

One health-system’s strategy for becoming a specialty pharmacy contractor.

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•

13

Continuous vs. intermittent IV antibiotic dosing: why the disconnect between hospital and home?

Educational Review

14

Compatibility of Commonly Used Intravenous Drugs

see ARALAST, page 1

see TPN REGIMENS, page 3

Clinical Controversies

Coding Consult POLICY WATCH

Joint Commission Eyes Stronger Oversight Of Specialty Pharmacy

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see COMMISSION, page 1

Top 10 Coding Mistakes—And How To Fix Them

See page 50.

Each issue will provide essential clinical and business information for stakeholders in specialty pharmacies, home infusion providers, insurers and managed care organizations.

Our goal: to help foster high-quality, cost-effective treatment across the entire patient-care continuum.

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New Products Ipilimumab (Yervoy, BMS) approved for metastatic or unresectable melanoma.

A new quarterly publication from the editors and publisher of Pharmacy Practice News.

Scriptpro announces new enhancements to its remote telepharmacy system.

See page 50.

Bridging the gap between the hospital and post-discharge care

THREE OPTIONS TO BALANCE YOUR VANCOMYCIN NEEDS

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Medication Delivery

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