The February 2013 Digital Edition of Pharmacy Practice News

The Pharmacist’s News Source

pharmacypracticenews.com

Volume 40 • Number 2 • February 2013

Printer-friendly versions available online

in this issue UP FRONT

3

Doxepin eases mucositis pain in radiation therapy.

CLINICAL

4 9

Tips for halting unsafe injection practices.

Mother–child methylergonovine mix-ups prove deadly.

OPERATIONS & MGMT

18 22

ED pharmacists’ value on display during ASHP Midyear meeting.

Hospitals push practice change via PPMI

TECHNOLOGY

28 29

WellSpan claims a first: IV prep and EHR integration.

Mobile app promises to lessen pain of med reconciliation.

EDUCATIONAL REVIEW

The Use of Opioids in Chronic Pain: Complexity and Practice Visit pharmacypracticenews.com

Drug Shortages In Cancer Pose Risk to Patients

I

Hospitals Too Often Neglect Drug Safety Education: ISMP E

nvestigators have published the first clinical evidence that a persistent drug shortage has the potential for compromising patient care. They documented a 13% drop in two-year event-free survival rates when pediatric patients with Hodgkin’s lymphoma were given cyclophosphamide in place of mechlorethamine when the latter chemotherapy agent was in extended short supply.

The study, published in The New England Journal of Medicine (2012; 367:2461-2463), “is eye-opening, given the changes in response rates and potentially even overall survival that resulted from the mechlorethamine shortage,” said Jeff Kaiser, PharmD, BCOP, a specialist in hematologic malignancies at the University of Colorado Hospital in Denver, who was not involved in the research.

The opportunity to evaluate the effects of the drug shortage emerged during the middle of an existing

ducating pharmacists, nurses and physicians in medication safety and evaluating their knowledge and skills in that area are vital if hospitals want to avoid the errors that seriously harm patients and drive up costs.

All too often, however, hospitals with other pressing needs push education and staff competency assessment to the back burner. The result, said Matthew Grissinger, RPh, the director of error reporting programs at the Institute for Safe Medication Practices (ISMP), in Horsham, Pa., is that they miss opportunities to enhance their patient safety strategies.

Speaking at a recent ISMP webinar, titled “Improving Medication Safety through Staff Education and Competency Assessment,” Mr. Grissinger described some of the problems the ISMP witnesses during hospital consult visits across the country. Competency assessments, he said, are frequently inconsistent throughout an organization. “Often,” he added, “we’ll see competency tests that are really calculation tests, and that’s it.”

see SHORTAGE, page 6

see ISMP SURVEY, Y page 10

•

More Smart Savings From ASHP Meeting Las Vegas—Deciding where to treat patients may be just as important as what to treat them with—at least when it comes to saving health care dollars, according to one of several pharmacoeconomic studies presented at the American Society of Health-System Pharmacists Midyear Clinical Meeting.

The positive effect that site of care can have on finances was demonstrat-

•

see SMART SAVINGS, page 24

•

Pharmacists a-Twitter: Is It Time To Ride This Social Media Wave?

A

fter former President Bill Clinton spoke at the American Society of HealthSystem Pharmacists (ASHP) P) Midyear Clinical Meeting in December,, press releases described thee overarching themes of his talk, which focused on the intersections among health, economicss and politics.

But Rachelle “Shelly” Spiro o, RPh, FASCP, a Las Vegas–based pharmacist and health care technology advocate, was impressed by something else the former president said. “Pres.

Clinton gets medication advice from his local independent #pharmacist,” she reported to her nearly 650 Twitter followers. h “He said that after he’d had his heart attack, he goes and ttalks to his community pharmaacist for advice,” said Ms. Spiro, wh ho tweets using the name @ shelllyspiro. “That isn’t something that tthe media would capture, but I thoughtt it was pertinent for my followers, and d iit got a lot of retweets.”

Twitter: It’s not just for Ashton Kutcher and

•

see a-TWITTER, page 16

New Products Hydrocodone/APAP 7.5 mg/325 mg unit-dose tablets among new AHP offerings.

McKesson launches new ExpressRx Track™ pharmacy automation solution.

See page 21.

See page 21.

Up Front 3

Pharmacy Practice News • February 2013

Capsules

Doxepin Reduces Mucositis Pain

surf

FEBRUARY 2013

watch

The five most-viewed articles last month on pharmacypracticenews.com: 1. Pharmacists Help With CMS Core Measure Adherence 2. Fibrate-Statin Label Changes Call for New Protocols 3. Smart Strategies for Savings Presented at ASHP Meeting 4. In Fight for Safe Compounding, a Salvo From NABP 5. Starting an Emergency Department Pharmacy at Low Cost Register for free at pharmacypracticenews.com to read these and other articles on the latest developments in hospital pharmacy.

Web Exclusive Compounding Oversight Heats Up A handful of states across the country are moving swiftly to shore up their regulatory defenses against the possibility of a post-NECC pharmacy compounding disaster. In this webN talks with experts who are spearheading exclusive article, PPN these oversight efforts. Plus, we explore potential solutions to ensure safe compounding in your own hospital.

Full story, visit www.pharmacypracticenews.com or scan the QR R code.

BOSTON—A large clinical trial has shown that a water-based rinse containing the tricyclic antidepressant doxepin reduces mucositis pain in patients with head and neck cancer who are undergoing radiotherapy.

Robert Miller, MD, a professor of radiation oncology at Mayo Clinic in Rochester, Minn., who presented the study at the annual meeting of the American Society for Radiation Oncology (abstract LBA2), said doxepin provides a new standard for treatment of radiotherapy-induced oral mucositis.

The Alliance for Clinical Trials in Oncology launched the N09C6 trial, a doubleblind, Phase III randomized controlled trial, after a small study suggested doxepin— approved for depression/anxiety and moderate pruritus but used off-label for pain conditions—reduces mucositis pain in patients with cancer (J Pain Symptom Manage 2007;33:111-114).

The study enrolled 155 adults with head and neck cancer from 26 institutions. The patients were eligible if they had received radiation therapy in which at least 30% of the oral cavity was treated and had developed mucositis pain of at least a 4 on a scale of 0 to 10. Patients received a single dose of doxepin, 25 mg of the drug in 5 mL of water, or a placebo of water on day 1 of the study. On day 2, patients crossed over to receive the opposite agent. Roughly 80% of patients received concurrent chemotherapy, and baseline patient characteristics were balanced in the two arms.

Pain was assessed on a scale of 1 to 10 via a questionnaire that was completed at baseline and then at five, 10, 30, 60, 120 and 240 minutes post-baseline. The primary study end point was total pain reduction, as calculated by average patient-reported mouth and throat pain, measured over the four-hour period after drug administration on day 1. Doxepin was more effective at reducing pain (area under the curve reduction, –9.1 vs. –4.7; P=0.0003). On average, over time doxepin reduced a patient’s pain score by 2 points, whereas placebo reduced the score by 1 point.

Patients receiving doxepin reported a temporary burning and stinging, an unpleasant taste and a mild increase in drowsiness, but the agent was well tolerated. After the double-blind, crossover portion of the study, 64% of patients opted to continue using doxepin (P=0.002).

“There are many institutional recipes for head and neck cancer symptom treatment, but relatively limited rigorous clinical trial data,” commented Paul Harari, MD, the chairman of human oncology at the University of Wisconsin, in Madison. Before calling doxepin a new standard of care, he said further research was warranted. One goal for such investigations, he noted, should be to determine whether the transient 1-point reduction in pain score over placebo seen in the NO9C6 trial justifies the introduction of a new class of agent for these patients or whether a slight adjustment in pain medication or numbing rinse might achieve the same effect.

—George Ochoa Dr. Miller reported that he is involved with Tekcapital’s scientific advisory board.

Dr. Harari reported no relevant financial conflicts of interest.

EDITORIAL BOARD

ART/PRODUCTION STAFF

ADMINISTRATION

Michele McMahon Velle, MAX Graphics/Creative Director

Robert Adamson, PharmD, Livingston, NJ

Frank Tagarello, Senior Art Director/Managing / Director, r MAX Graphics

Ernest R. Anderson Jr., MS, RPh, Boston, MA

Volume 40 • Number 2 • February 2013 • pharmacypracticenews.com

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

INTERNAL MEDICINE

EDITORIAL STAFF

David S. Craig, PharmD, BCPS, Tampa, FL

Geoffrey C. Wall, PharmD, FCCP, BCPS, CGP, Des Moines, IA

David Bronstein, Editorial Director davidb@mcmahonmed.com

Robert L. Barkin, MBA, PharmD, Chicago, IL

NUCLEAR PHARMACY

BIOTECHNOLOGY Jeffrey Norenberg, PharmD, Albuquerque, NM

Indu Lew, PharmD, Livingston, NJ

Sarah Tilyou, Senior Editor smtilyou@mcmahonmed.com

CARDIOLOGY

ONCOLOGY

C. Michael White, PharmD, Storrs, s CT

Robert T. Dorr, PhD, RPh, Tucson, AZ

Kevin Horty, Don Pizzi, Adam Marcus, Cynthia Gordon, Contributing Editors

CNS/PSYCHIATRY

Robert Ignoffo, PharmD, San Francisco, CA

James Prudden, Group Editorial Director

Charles F. Caley, PharmD, Storrs, CT

Philip E. Johnson, MS, RPh, FASHP, Tampa, FL

Robin B. Weisberg, Manager, r Editorial Services

Cindy O’Bryant, PharmD, Aurora, CO

Elizabeth Zhong, Associate Copy Chief

Lawrence Cohen, PharmD, FASHP, FCCP, Fort Worth, Texas Larry Ereshefsky, PharmD, San Antonio, TX COMPLEMENTARY AND ALTERNATIVE MEDICINE

Ali McBride, PharmD, MS, BCPS, St. Louis, MO

Cathy Rosenbaum, PharmD, Cincinnati, OH

Sara S. Kim, PharmD, BCOP, New York, NY

CRITICAL CARE

PEDIATRICS

Judi Jacobi, PharmD, FCCM, Indianapolis, IN

Gretchen Brummel, PharmD, BCPS, Hudson, OH

SALES David Kaplan, Group Publication Director dkaplan@mcmahonmed.com

James O’Neill, Senior Systems Manager Dan Radebaugh, Director of Production and Technical Operations Marty Barbieri, Production Manager Brandy Wilson, Circulation Coordinator

McMAHON PUBLISHING Raymond E. McMahon, Publisher and CEO, Managing Partner Van Velle, President, Partner Matthew McMahon, General Manager, Partner Lauren Smith, Michael McMahon, Michele McMahon Velle, Rosanne C. McMahon, Partners

MCMAHON PUBLISHING MCMAHONMED.COM Sales, Production and Editorial Offices: 545 West 45th Street, 8th Floor, New York, NY 10036.

Telephone: (212) 957-5300.

Corporate Office: 83 Peaceable Street, Redding CT 06896

David P. Nicolau, PharmD, Hartford, CT

TECHNOLOGY

Robert P. Rapp, PharmD, Lexington, KY

Thomas Van Hassel, RPh, Yuma, AZ

Alina Dasgupta, Junior Sales Associate, e Classified Advertising adasgupta@mcmahonmed.com

Copyright © 2013 McMahon Publishing, New York, NY 10036. All rights reserved. Pharmacy Practice News (ISSN 0886-988x) is published monthly by McMahon Publishing. Periodicals postage paid at New York, NY, and at additional mailing offices. POSTMASTER: Send address changes to Pharmacy Practice News, Circulation Dept., 545 W. 45th St., 8th Floor, New York, NY 10036.

WANT TO SUBSCRIBE? CHANGE YOUR ADDRESS? HERE’S HOW All U.S. hospital pharmacists should receive Pharmacy Practice News free of charge. If you are a hospital pharmacist and do not receive the publication, you must add your professional address or make your address change directly

with Pharmacy Practice News, Circulation Dept., 545 W. 45th St., 8th Floor, New York, NY 10036. You can also fax your request to (212) 977-3645, or send it via email, circulation@mcmahonmed.com.

If you are not a hospital pharmacist but would like to receive Pharmacy Practice News, please send a check for $70.00 (U.S.) or $90.00 (outside U.S.) for a year’s subscrip-

tion payable to Pharmacy Practice News to McMahon Publishing, 545 West 45th St., 8th Floor, New York, NY 10036.

Please allow 8 to 12 weeks for delivery of the first issue.

Individual issues are $7.00 (U.S.) or $10.00 (outside U.S.).

McMahon Publishing is a 41-year-old, first-generation, family-owned publishing company dedicated to providing medical professionals with essential, up-to-date news. As

the second largest publisher of medical newspapers, McMahon produces Anesthesiology News, Clinical Oncology News, Gastroenterology & Endoscopy News, General Surgery News, Infectious Disease Special Edition, Pain Medicine News, Pharmacy Practice News.

Rheumatology Practice News and Specialty Pharmacy Continuum.

INFECTIOUS DISEASES

REIMBURSEMENT

Steven J. Martin, PharmD, BCPS, FCCM, Toledo, OH Peggy McKinnon, PharmD, Lexington, M MA

Bonnie E. Kirschenbaum, MS, FASHP, Breckenridge, CO

A family-owned medical publishing and medical education company. McMahon publishes seven clinical newspapers and several annual or semiannual Special Editions.

Matt Spoto, Senior Account Manager mspoto@mcmahonmed.com David Nathanson, Account Manager dnathanson@mcmahonmed.com

4 Clinical

Pharmacy Practice News • February 2013

Medication Safety

Halting Unsafe Injection Practices Still a Challenge A

n infection spread by unsafe injection practices can happen anywhere. In 2008, it happened at an endoscopy clinic in Las Vegas. When a patient infected with hepatitis C was injected with propofol from a singledose vial, backflow contaminated the syringe. Nurses reused the syringe to draw additional medication from the vial after replacing the needle. By placing the reused syringe in contact with the vial, they contaminated the vial.

The routine reuse of single-dose vials for multiple patients resulted in an outbreak of hepatitis C. Joseph Perz, DrPH, a health care epidemiologist at the Centers for Disease Control and Prevention (CDC) in Atlanta, recounted the story of the Las Vegas outbreak in a Nov. 13 CDC webinar, “Unsafe Injection Practices in the U.S. Healthcare System.”

Since 2001, Dr. Perz said, at least 48 outbreaks caused by unsafe injection practices have occurred in the United States, with the majority (90%) in outpatient settings (10 in pain clinics and nine in oncology clinics). Twentyone of the outbreaks involved hepatitis B or hepatitis C; 27 were bacterial.

More than 150,000 patients required notification to recommend bloodborne pathogen testing following exposure to unsafe injections.

Dr. Perz noted that contamination can occur with syringes as well as other medication containers. For example, he noted that syringes can be reused indirectly, as in the Las Vegas case, in which a reused syringe contaminated a vial, or directly, in which a single syringe is used for several patients. Insulin pens also can be reused mistakenly, causing contamination. For example, it was reported in January that insulin pens may have been reused unintentionally in more than 700 patients at the Buffalo Veterans Affairs Medical Center, possibly exposing the patients to HIV, hepatitis B and/or hepatitis C. Another potential problem occurs when a single-dose vial is used for multiple patients. Because the singledose vials typically lack preservatives, this practice carries risks for bacterial contamination. IV bags also are often mistakenly used as a common source of supply for multiple patients. “Another concern is that clinical staff may spike, or prepare, batches of IV bags, or draw multiple syringes out of vials, and hold them indefinitely although they are preservative-free,” Dr. Perz told Pharmacy Practice News.

Darryl S. Rich, PharmD, MBA, FASHP, medication safety specialist, Institute for Safe Medication Practices (ISMP), in Horsham, Pa., who was not associated

sage is meant to be clear and to the point. “We do not want any health care provider telling us they didn’t know better when it comes to syringe reuse and other unsafe injection practices,” Dr. Perz noted.

Among the campaign’s resources is an injection safety checklist that providers can use to assess adherence to safe injection practices (Figure). “The injection safety checklist is meant for providers to stop [and] take a moment to examine their practices, that of their staff and peers,” Dr. Perz said. Campaign staff recently launched additional new materials, including an animated video, a podcast, posters and a bloodborne pathogens training activity (http://www.oneandonlycampaign. org/ news/ new-tools-help-cliniciansensure-every-injection-safe).

Pharmacists Need To Be Part of Team Effort

‘The most egregious [unsafe injection practice] is the reuse of the same syringe. That is probably the top in causing infections. Also egregious is using single-dose vials for multiple patients.’

—Darryl S. Rich, PharmD, MBA, FASHP with the CDC webinar, said, “The most egregious [unsafe injection practice] is the reuse of the same syringe. That is probably the top in causing infections.

Also egregious is using single-dose vials for multiple patients.”

Multiple-dose vials also can be associated with contamination, Dr. Rich said. “A CDC safe injection practice is that a multiple-dose vial should not be opened and stored in the immediate patient treatment area,” said Dr. Rich. “If it is, it should be used only for one patient and then discarded. A lot of hospitals don’t agree with this particular guideline because of the cost involved. CDC has evidence that these vials in close contact to patients can

cause cross-contamination, so I think it makes sense. It takes a little creative thinking. See if there are areas to draw up doses from multidose vials farther from the patient. Use singledose vials instead of multidose vials.

The best approach is to use prefilled syringes drawn up using automation in the pharmacy or prepared from an operating room satellite.”

The Safe Injection Practices Coalition—a partnership of health care– related organizations that includes the CDC and ISMP—is leading an effort to raise awareness about safe injection practices. The slogan of the coalition’s One & Only Campaign, is: “One needle, one syringe, only one time.” The mes-

Pharmacists have an important role to play in ensuring safe injection practices, stressed Dr. Perz. “Pharmacists are in a good position to understand how important it is to maintain sterility of injectable medications. The pharmacists’ vigilance can extend to the point of care, to ensure safe and appropriate use of dispensed medication products.”

“If there’s a shortage, the pharmacy should break the drug in large singledose vials down into individual units,” Dr. Rich said. “The pharmacist needs to work with the infection control coordinator. It’s a team effort.”

Dr. Perz suggested three “E’s” for ensuring safe injections: “Epidemiologic capacities and resources,” “Educational initiatives,” and “Enforcement and oversight.” Pharmacists, he said, have a role in all three: recognizing patterns and opportunities for prevention (epidemiology), educating providers about appropriate practice (education), and participating in walkthroughs and audits (enforcement).

A study published Dec. 10 online in American Health & Drug Benefits delineated the effects of preventable adverse drug events (ADEs), such as those caused by unsafe injection practices. The study, commissioned by BD, showed that such ADEs affect more than 1 million hospitalized patients and cost $2.7 billion to $5.1 billion annually.

—George Ochoa with additional reporting

by Sarah Tilyou Drs. Perz and Rich reported no relevant financial conflicts of interest.

IV Clinical Integration enhances efficiency and patient safety through simplified delivery and documentation.

The days of writing IV information on scrub legs, bed sheets or the back of your hand are over.

IV Clinical Integration captures pump settings from the physician’s order and provides near realtime documentation by linking the IV pump, patient, order and record. As the most experienced provider of IV Clinical Integration, Hospira is committed to giving you and your staff the knowledge, expertise and support to help you set new standards in IV drug delivery workow.

To see IV Clinical Integration in a live setting, scan this code with your mobile device or go to http:\\ivclinicalintegration.com.

For more information, call 1-800-237-5512.

Hospira, Inc., 275 North Field Drive, Lake Forest, IL 60045

P12-3758-May, 12

6 Clinical

Pharmacy Practice News • February 2013

Medication Safety

SHORTAGE continued from page 1

study of a 12-week chemotherapy regimen of mechlorethamine, vinblastine, doxorubicin, vincristine, bleomycin, etoposide and prednisone. Known as the Stanford V regimen, the strategy was believed to be as effective as, and safer than, existing treatments for pediatric Hodgkin’s lymphoma, according to lead author Monika Metzger, MD, an associate member in the Oncology Department at St. Jude Children’s Research

‘We’ve seen evidence that the rate of new [drug] shortages has decreased, which is great.

Unfortunately, the shortages we’re following are taking a long time to resolve.’

—Erin Fox, PharmD Hospital in Memphis, Tenn. But the study hit a snag when a worldwide shortage of mechlorethamine occurred in 2010. Dr. Metzger and her colleagues had already treated 181 patients with the regimen by the time the mech-

Unit Dose Done Right

lorethamine shortage occurred. In an effort to find a substitute, they searched the literature and identified cyclophosphamide as a potential equivalent. That drug had been widely used in adults and children with Hodgkin’s lymphoma as

Unit Do se Bar Cod , ing, Pharma c Nursing y & Supply Experts !

Ultraviolet Inhibitant Moisture Resistant Tamper-Evident Cold Seal 6 and 12-month Beyond-Use Dating 1-D and 2-D Bar Coding Flexible Label and Report Formatting Multiple Sizes to Fit Your Meds and SStorage N Needs d

Simple. Reliable.

800.523.8966

MediDose.com

part of the COPP (cyclophosphamide, vincristine, procarbazine and prednisone) regimen; COPP was thought to be as effective as the almost identical mechlorethamine-based MOPP (mechlorethamine with the same three drugs) regimen. By 2012, when mechlorethamine again became available after two years, they had treated 40 patients with the cyclophosphamide-based Stanford V regimen, accumulating enough data to retrospectively compare outcomes using the two treatment arms.

Their analysis showed that twoyear event-free survival rates dropped from 88% when mechlorethamine was used to 75% with cyclophosphamide ( =0.01). Statistical analyses controlling (P for possible confounding variables confirmed that the disparity in outcomes was indeed due to the regimen changes.

Although overall survival rates did not differ between the groups, Dr. Metzger noted that the median follow-up in the cyclophosphamide group was only 1.5 years compared with 4.7 years in the mechlorethamine group.

For Dr. Metzger and her colleagues, the lesson learned was clear: “What might appear to be a suitable alternative may result in an inferior outcome,” she told Pharmacy Practice News. “In case a shortage like this were to happen again, I would look for an alternate regimen with a track record and for which all drugs are available rather than try to go for a substitution. I would only use a substitution as the very last resort.”

Oncology Pharmacist’s Take The study “begs the question of whether we have enough data on comparative clinical efficacy” to effectively managed shortage-driven therapeutic substitutions, said Ali McBride, PharmD, a stem cell transplant specialty practice pharmacist in the Department of Pharmacy at Ohio State University’s Arthur G. James Cancer Hospital in Columbus.

“When there are shortages, there may be suggestions for other therapies, but

Clinical 7

Pharmacy Practice News • February 2013

Medication Safety head-to-head data are rarely available,” said Dr. McBride. “As this study demonstrates, we don’t always know what the outcome will be.”

Although Dr. McBride was not involved in the NEJM M trial, he and his colleagues have conducted their own research on the effects of oncology drug shortages. The study has been accepted for publication and should be released in the coming months, Dr. McBride noted. He said the surveybased findings are expected to provide further evidence that drug shortages have negatively affected outcomes in certain cancer patients.

William Greene, PharmD, who is chief pharmaceutical officer at St. Jude, said his hospital has faced more than a decade of drug scarcities, but the mechlorethamine shortage was different. “We’ve

Seven Ways To Manage a Chemo Drug Shortage

1

Look to a different wholesaler other than the one your pharmacy is contracted with. They might have a larger stock or supply of drug that is produced by a different manufacturer.

3

Try to place an order directly with the manufacturer. During a shortage, many manufacturers allocate product to direct customers. The company may also have an emergency supply for completing a patient cycle.

4

Consider using drugs manufactured outside of the United States as long as good manufacturing practices are followed and the FDA and your state’s board of pharmacy have approved it.

5

Look to drug manufacturers, literature searches and tertiary references for ways to extend drug stability and help prevent wastage of any drug in short supply.

6

Consider rounding doses and scheduling patients on the same day when possible to avoid waste.

Ensure that in extreme shortages curable cancers are given priority, especially when no other alternatives exist.

it’s rare that such a severe shortage occurs,” he said. “When a severe situation does occur, we pull in the relevant group of physicians, engaging them in a discussion, informing them of the critical nature of the shortage and what we believe will happen with the drug supply, how long we expect the shortage to persist, and then we make recommendations for a discussion on alternative therapies.”

In some cases, Dr. Greene added, “we ask the physicians for guidance about other ways to extend the drug supply, such as prioritizing use for patients who

•

see SHORTAGE, page 8

EXPAREL is the only single-dose local analgesic that…

• Provides up to 72 hours1* of analgesia with • Reduced opioid requirements1† • Without the need for catheters or pumps

EXPAREL is a liposome formulation of bupivacaine indicated for administration into the surgical site to produce postsurgical analgesia.

Important Safety Information: EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting. *Pivotal studies have demonstrated the safety and efficacy of EXPAREL in patients undergoing bunionectomy or hemorrhoidectomy procedures; additional studies are underway to further demonstrate the safety and efficacy in other procedures. † The clinical benefit of the attendant decrease in opioid consumption was not demonstrated.

Reference: 1. Gorfine SR, Onel E, Patou G, et al. Bupivacaine Extended-Release Liposome Injection for Prolonged Postsurgical Analgesia in Patients Undergoing Hemorrhoidectomy: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial. Dis Colon Rectum. Dec 2011;54(12):1552-1559.

Please see brief summary of Prescribing Information on back page.

Sources: Drs. Kaiser and Fox

really are going to benefit the most, and we also look at operational ways to minimize use of a drug such as dose rounding, scheduling multiple patients on the same day or other procedures that minimize waste.”

Although the challenge of managing prolonged shortages can seem insurmountable, there are measures pharmacists can implement to preserve diminishing stock, said the University of Colorado’s Dr. Kaiser. “When we don’t expect any more of a drug in shortage

postsurgical pain control for u s e d i v p to 7 pro e s 2 ho o d urs * e On

Rather than stockpiling a drug, order only what is needed for current patients. This may be especially helpful in cases of drugs with short expiration dates as a way of ensuring they are not wasted.

2

7

been forced many times to make decisions on alternative therapies, but for the most part, those decisions are made based on evidence and, for the most part, we’re very comfortable that the alternatives are equally effective as the original drug we would choose,” he said. In the case of mechlorethamine, he said, there was a lack of data on proven alternatives.

Dr. Greene said St. Jude follows a “disciplined process” for coping with drug shortages when they hit. “If it gets to the point of a severe shortage, managing it can be intense, but fortunately

For more information, visit www.EXPAREL.com

8 Clinical

Pharmacy Practice News • February 2013

Medication Safety

SHORTAGE

ments. “Pharmacists can do a great deal when there are shortages, in terms of seeking out product from alternate sources and prioritizing use of limited stock, but once it gets past that point to where there is no drug, there’s not much you can do,” she told Pharmacy Practice News. (For tips that do work when coping with chemotherapy drug shortages, see sidebar.)

continued from page 7

to be available for weeks or months, decisions become complex,” he said.

“We have seen this in the past year with drugs such as thiotepa and foscarnet sodium, which most pharmacies could only purchase from manufacturers outside of the United States. When a worldwide shortage occurs, substitutions with potentially less data may need to be considered.”

Erin Fox, PharmD, the director of

the drug information service at the University of Utah Hospitals & Clinics in Salt Lake City, whose service pro-

vides shortage data for the American Society of Health-System Pharmacists (ASHP), echoed Dr. Kaiser’s senti-

Hard Evidence Lacking The St. Jude data are invaluable in terms of documenting the safety and efficacy of potential drug alternatives and in demonstrating the toll extended drug shortages can take on patients.

However, Dr. Greene does not expect that similar opportunities to examine the effects of drug shortages on patient outcomes will arise. “Most shortages are short-term, often do not affect large groups of patients and do not cause us to exhaust our stocks,” he said. “Mechlorethamine was certainly the most significant and persistent chemotherapy shortage that affected a large number of our patients.”

Nevertheless, collecting data on a piecemeal basis also can be important, Dr. Fox said. And pharmacists can play a significant role in doing so. “If they’re using substitutes, pharmacists can put together a retrospective review to evaluate outcomes or differences in rates of adverse effects or medication errors during the time of substitution,” she said. “That’s really important information to have and it doesn’t have to be only physicians who do this data collection.”

Dr. Fox added some mixed news regarding the number of shortages that have been occurring. “We’ve seen evidence that the rate of new shortages has decreased, which is great,” she said.

“Unfortunately, the shortages we’re following are taking a long time to resolve.”

More Resources For more information on current and anticipated drug shortages and suggestions on how to manage them, visit the websites of the ASHP (www.ashp.org/ menu/drugshortages/resources) and the FDA (www.fda.gov/drugs/drugsafety/ ( drugshortages/default.htm). m Additionally, the February issue of Clinical Pharmacology & Therapeutics ((www.nature.com/ clpt/index.html) includes several articles, including a commentary by Dr. Fox, that delve into the underlying causes of drug shortages. In one of the articles, the authors point to a lack of incentives for quality manufacturing that, if addressed, could mitigate the drug-shortage crisis.

—David Wild EX-AP-0020-201111 EX-AP-0039-201201

Drs. Metzger, Greene, Kaiser and Fox reported no relevant financial conflicts of interest.

Clinical 9

Pharmacy Practice News • February 2013

Medication Safety

Mother–Child Methylergonovine Mix-up Proves Deadly

S

everal neonates have mistakenly received methylergonovine maleate, a synthetic ergonovine analogue indicated for the management of postpartum atony, hemorrhage and subinvolution, in some causes due to look-alike or sound-alike pediatric drugs being stored in proximity to the ergot drug. To date, one fatality has been reported.

In response, American Regent, which manufactures the generic version of methylergonovine maleate, has sent out a “Dear Healthcare Professional” letter warning of the possibility for these potentially lethal mistakes.

“Toxic doses of ergot compounds may cause serious adverse effects in newborn infants such as respiratory depression, cyanosis, oliguria and seizures,” Walter Tozzi, RPh, MS, MBA, the vice president of professional services at American Regent, wrote in the letter dated Dec. 18, 2012. “Death may result from ergotassociated respiratory depression.”

The 1-mL vial of methylergonovine maleate contains 0.2 mg of the drug— an “overdose of great magnitude” when mistakenly administered to newborns, a revised product monograph will state, according to Mr. Tozzi. The new monograph also will caution that, in addition to the single neonatal death, the drug has caused respiratory depression, hypothermia, hypertonicity with jerking movements, and one case of convulsions.

ric medications • Designating separate automated dispensing cabinets (ADCs) and refrigerators for mother and newborn medications • Administering medications to newborns outside of the birthing area • Applying label reminders to prevent medication mix-ups • Informing staff about the potential for these errors

Mr. Tozzi said that American Regent is currently modifying the drug’s label as an additional way to help prevent further administration errors.

ISMP is not the only source of reports linking Methergine to drug mixups; the problem with the branded drug also was described in a July 2012 letter issued

by Novartis and on the websites of the American Society of Health-System Pharmacists and the FDA. As with the

ISMP reports, Novartis’ letter detailed several cases of Methergine being used instead of Engerix-B, and one case of mistaken use of an oral liquid formulation of Methergine in place of vitamin K. However, Dr. Cohen noted that Novartis stopped marketing Methergine in the United States in early 2012, and that the liquid oral formulation of Methergine was never available in this country. The see NEONATES, page 15

CRITICAL CARE

Reasons for Errors Michael Cohen, RPh, MS, ScD, the president of the Institute for Safe Medication Practices, spoke with Pharmacy Practice News about the reasons for the methylergonovine maleate drug errors. In some of the cases reported to ISMP’s National Medication Error Reporting Program, he noted, the drug had been injected in an infant instead of the similar-looking Engerix-B (GlaxoSmithKline) hepatitis B vaccine. In other cases, he said, mix-ups occurred when Methergine, a branded version of methylergonovine maleate marketed by Novartis, was confused with a similar-sounding obstetrics medication, Brethine (AAIPharma; terbutaline).

“The drugs are sometimes stored in the same cabinet in perinatal areas; they look or sound alike; they’re brought into the nursing room at the same time; and so they’re in jeopardy of being mixed up by the nurse,” said Dr. Cohen, who reported several other cases of methylergonovine maleate being administered to neonates instead of mothers in the Aug. 23, 2012, ISMP Medication Safety Alert!

(17[17]:1,3. Dr. Cohen said he endorses the preventive measures outlined in American Regent’s letter, including: • Physically separating methylergonovine maleate from injectable pediat-

•

READY, SET, GO!

We now have Tranexamic Acid Injection!

Medical Information 800-551-7176 Customer Service 888-386-1300 www.APPpharma.com

DROP-BY-DROP. VIAL-BY-VIAL. A VITAL FOCUS ON SAFETY AND SUPPLY. APP® and are trademarks of Fresenius Kabi USA, LLC. ©2012, Fresenius Kabi USA, LLC. All Rights Reserved. 0424-TRA-05-09/12

10 Clinical

Pharmacy Practice News • February 2013

Medication Safety

ISMP SURVEY continued from page 1

A VA Hospital That Values Education In contrast, some hospitals make it a point to build staff education and competency assessment into their daily routines. At the ISMP webinar, Alexander Reiss, MD, the chief of the Hospitalist Section at the James A. Haley Veterans Hospital and Clinics in Tampa, Fla., described a safety culture at the 548-bed VA facility that

‘[Medication safety] education is very siloed—which is kind of odd because we’re expected to work as a team in our systems.’

—Matthew Grissinger, RPh 100

Percent (%)

Additionally, Mr. Grissinger said, ISMP often encounters a lack of standardized interdisciplinary education, “meaning education is very siloed— which is kind of odd because we’re expected to work as a team in our systems.” He also noted a lack of consistent credentialing, training and certification as well as a lack of information-sharing about errors that occur, their causes and ways to prevent future ones.

Supporting ISMP’s hospital-consult observations, Mr. Grissinger presented results from the group’s most recent Medication Safety Self-Assessment survey, encompassing responses from more than 1,300 organizations. The survey, which has been submitted for publication, uncovered spotty adherence to some of ISMP’s core characteristics of effective staff education and competency assessment.

Overall, Mr. Grissinger said, respondents achieved an average score of only 64% on questions designed to assess whether practitioners receive sufficient orientation on medication use; undergo baseline and annual competency evaluation of knowledge and skills related to safe medication practices; and whether they receive ongoing education on medication error prevention and the safe use of high-alert drugs.

Certain items produced particularly low scores (Figure). For example, in 34% of the respondents’ hospitals, new staff pharmacists undergoing orientation are not assigned to spend time in patient care units becoming familiar with drug prescribing practices, unit stock storage conditions, medication administration procedures and patient education practices. Additionally, nearly 72% of respondents noted that newly hired nurses do not spend time in the pharmacy or with clinical pharmacists during orientation.

Other low-scoring measures included whether pharmacists participate in the orientation of new medical staff and whether the organization provides formal teamwork planning. Nearly 47% of respondents said their hospitals don’t include pharmacists in medical staff orientation, and nearly 34% reported a lack of teamwork exercises.

80

72b

Multiple Sites Present Another Challenge

60 47a 40

34

20 0 Hospitals that don’t assign new staff pharmacists to patient-care unit training

Hospitals that don’t include pharmacists in medical staff orientation

Hospitals that don’t have nurses spend time in the pharmacy or with clinical pharmacists during orientation

Figure. ISMP Medication Safety Self-Assessment survey results on education and testing. a,b

Rounded figures

‘How do we begin to discuss medication errors and improving medication use practices if we’re all speaking a different language?”

—Kyle Hultgren, PharmD emphasizes a bottom-up, interdisciplinary approach to error prevention.

“We have a morning report every day,” Dr. Reiss said, “and once a week we’ll spend about 15 minutes on just a quick topic on patient safety or quality. It’s often entertaining and very interactive, so no one gets too bored, and they learn a little bit along the way.”

Additionally, he said, the VA hospital’s regular morbidity and mortality conference, which “used to be about blame and shame and where did it go wrong and who is responsible,” now focuses on a “systems approach to medical errors—how can we find ways to prevent them and fix systems to work for us rather than against us.”

Dr. Reiss said one example of the VA

ture changes.” Dr. Reiss said that the process is “a very effective tool—a very interprofessional way to see where the problems exist within our system that we had no idea were even there.”

The safety group also schedules other interdisciplinary learning sessions, like the “environment of care” rounds, where a group visits a nursing unit room in which a patient has agreed to take part. “We just chat,” Dr. Reiss said.

“We point out things in the room, and the patient invariably tells us things that we weren’t aware of or didn’t even think about. That’s probably the most eye-opening part, the interaction with the patient.”

Mr. Grissinger provided webinar participants with a number of suggestions for improving their organizations’ safe medication use education programs, including using communication logs to share safety tips in patient care areas; introducing videotapes and interactive CD-ROM programs; conducting simulation exercises; and scheduling weekly safety rounds with front-line staff and management.

hospital’s interprofessional approach is its medication tracer program. He described how an interdisciplinary group of 10 to 12 students, nurses, medical residents, staff pharmacists and others regularly gathers to learn about vulnerabilities in medication use by following an actual order through the entire process, from computerized prescriber order entry to the pharmacy to administration by a nurse at the bedside. The detailed walk-through takes about an hour, he said.

The group is asked to come up with solutions to the problems they spot, Dr. Reiss said. Typically, “they start with weak solutions, but eventually come up with some really strong solutions, environmental changes and infrastruc-

Kyle Hultgren, PharmD, the managing director of the Center for Medication Safety Advancement at Purdue University, in West Lafayette, Ind., noted how challenging it can be to develop medication safety “standards inside of your hospital, let alone across the entire health system.” Part of the solution, he said, “comes down to defining a standard language. A lot of people have really excellent ideas, but how do we begin to discuss medication errors and improving medication use practices if we’re all speaking a different language?”

Still, making improvements “is certainly not impossible,” he said. “One of the things that ISMP does a great job in is stressing the notion of competency.” What they and other groups are trying to accomplish, he said, “is to create effective standards of care and make sure the people” adhere to them.

And assessing competencies, he added, helps to ensure that standards are followed. Good standards don’t “script patient care,” Dr. Hultgren said, but they do ensure that when “it comes time to provide patient care, we can think at the top end of our licenses.”

Dr. Hultgren also pointed out that developing medication safety standards cannot be accomplished solely through a “top-down” process. “The parameters, the guidelines and the cultural tone have to be set by the leadership,” he said, “but from the bottom-up is where the improvements start to happen. It’s really a collaborative approach across the entire spectrum.”

—Bruce Buckley

Making an Impact on Patient Safety

BD is committed to improving injectable drug delivery—helping patients, nurses and pharmacists manage medication risk.

To learn more about BD and our products visit www.bd.com/patientsafety

1 Becton Drive Franklin Lakes, NJ 07417 www.bd.com BD and BD Logo are trademarks of Becton, Dickinson and Company. Š 2013 BD. MSS0279

12 Clinical

Pharmacy Practice News • February 2013

Practice Pearl

Hepatitis C Model Delivers Great Care Anywhere Karine Rozenberg-Ben-Dror, PharmD VISN 12 HCV Task Force Manager Department of Veterans Affairs (VA) Clinical Pharmacy Specialist/Informatics Jesse Brown VA Medical Center Chicago, Illinois

James Duvel, PharmD VISN 12 Pharmacoeconomic Advisor Department of Veterans Affairs

Donna Leslie, PharmD

Table 2. Barriers To Optimizing Hepatitis C Therapy Barrier

Initial Circumstances

Goals

Suboptimal HCV RNA testing methods

• Quantification <43 IU/mL

• Quantification <10-15 IU/mL

Excessive laboratory turnaround time

• >2 weeks at some facilities

• <2 weeks for all facilities

Inadequate manpower or insufficient space

• Lack of hepatology service providers • Lack of manpower and dedicated clinic space • Admission to hospital for side effect management (psychiatry, blood transfusion)

• Provide access to expert opinion in difficultto-treat cases • Shared responsibilities and offsite support • Service agreements: mental health provider to see patients presenting with depression or anxiety while on HCV therapy, infusion clinic to provide blood transfusion during routine hours

Inadequate knowledge base

• New, inexperienced clinicians and variable use of electronic tools

• Enhance knowledge base by highlighting the availability of VA Criteria for Use of HCV agents, VA website, and electronic tools that contain Word documents and website links with tutorials

Inadequate reporting of ADEs

• Low reporting rates

• Standardize or improve electronic reporting in the medical record using group consensus

VISN 12 Pharmacy Executive Department of Veterans Affairs

Michael Bonner, MD Associate Chief of Staff for Informatics Milwaukee VA Medical Center Milwaukee, Wisconsin

I

n May 2011, the FDA approved the use of boceprevir (Victrelis, ScheringPlough) or telaprevir (Incivek, Vertex) in combination with pegylated interferon and ribavirin for the treatment of genotype 1 hepatitis C. These new protease inhibitors (PIs) promise to alter the landscape of hepatitis C treatments and outcomes.

New treatment algorithms for the treatment of hepatitis C virus (HCV) infection, termed response-guided therapy, require providers to conduct thorough reviews of prior treatments to determine eligibility for new triple regimens incorporating a PI, as well as to guide duration of therapy. Guided therapy involves knowledge of the degree of liver disease and prior treatment response at specified time points, depending on variables

Table 1. Role of the Task Force Managera Generate discussion to identify goals and objectives, and barriers to treatment.

Seek expert opinion to aid consensus development.

Attend national VA meeting(s) and communicate topics of pertinence or interest.

Identify and provide criteria for use, electronic tools (eg, monitoring guides, drug-drug interaction tool).

Coordinate resolution of problems related to laboratory and pathology, and reporting and management of ADEs. Review electronic records for ADEs and cases of interest for discussion at task force meetings.

Discuss or review the appropriate use of protease inhibitors, erythropoietin, and G-CSF. Encourage discussion about local best practice solutions and interesting/unusual patients. a

At meetings, via email, or one on one with providers ADEs, adverse drug events; G-CSF, granulocyte colony-stimulating factor

ADE, adverse drug event; HCV, hepatitis C virus

such as week of treatment and viral load.

Viral loads that decline rapidly identify patients who are highly responsive to therapy, as opposed to unresponsive patients who may need to stop treatment to avoid developing viral resistance.

Another factor to consider with triple therapy is adverse drug events (ADEs).

ADEs are common with PI-containing regimens and may be serious or lifethreatening. Frequently, providers need to adjust treatment or respond to these reactions to avoid termination of therapy and optimize treatment success. To further complicate management, more than 300 drug interactions with PIs have been identified; these include interactions with commonly prescribed agents for lowering blood pressure and cholesterol.

Optimal HCV treatment for patients in a comprehensive health system requires an efficient and effective process. Ideally, the established structure would support rural as well as urban settings and allow for sharing of information, education of providers, and metrics to monitor treatments. Such a process was established successfully within the Department of VA.

VA Task Force The VA hospitals and clinics are geographically clustered into groups called Veterans Integrated System Networks (VISN). There are 22 VISNs in the VA system. Facilities located in the states of Illinois, Wisconsin, and Michigan comprise VISN 12, which includes 7 unique urban and rural hospitals as well as satellite clinics that provide integrated care to approximately 200,000 veterans. Of these, approximately 3,000 patients have HCV genotype 1 and may be candidates for response-guided therapy.

The VISN pharmacy executive iden-

tified an HCV-experienced clinical pharmacy specialist to lead an HCV task force (TF) and queried each facility to identify a multidisciplinary group consisting of nurse practitioners, physicians (internal medicine, infectious disease, and gastroenterology/hepatology), and clinical pharmacy specialists.

The role of the TF manager was to optimize access to and treatment with PI-containing regimens (Table 1). The manager organized meetings, prepared reports, and encouraged members to share expertise and experiences.

The TF had to identify and resolve unique and common barriers, standardize the approach to therapy, and familiarize providers with complexities of the new HCV regimens. The TF conducted biweekly one-hour teleconfer ences. Through agendas and meeting minutes, the group tracked progress of the TF and provided communication

VISN CMO, pharmacy executive, TF manager, chiefs of laboratory and pathology

to those unable to join the conferences.

Meetings were held monthly or as needed, depending on the issues that were unresolved via the teleconferences.

The TF focused on identifying barriers to optimizing care and establishing goals to address such barriers as well as solutions to any problems related to HCV therapy (Table 2). These barriers included lack of manpower, insufficient clinic space, and suboptimal laboratory HCV RNA quantification. In several facilities, clinics with one clinician evolved to include the aid of a clinical pharmacist to review previous treatment history, reconcile medications, evaluate for potential drug-drug interactions, and recommend or initiate formulary agents to manage side effects. Identification of potential drug interactions occurred before HCV treatment was initiated, allowing timely use of alternative agents. The time that

•

see HEP C, page 14

Facility HCV clinic (ideally ≤2 providers) clinical pharmacy specialists, physicians, nurse practitioners, registered nurses

Figure. VISN Ferris wheel model.a a The Ferris wheel model is supported by national groups. The momentum is driven by the task force manager and facility providers who network and may seek expert guidance on a national level to resolve issues.

As the wheel turns, providers may interact at national meetings to share and gather new information that can be redistributed by the task force to various facilities.

CMO, chief medical officer; HCV, hepatitis C virus; TF, task force; VISN, Veterans Integrated System Networks

Sometimes appearances are everything.

New FDA-approved IV premix drug labeling from Baxter.

To help reduce medication errors due to incorrect drug selection, we redesigned the labeling for some of our most widely used liquid premix medications. We decreased the clutter and placed information in a consistent manner. Contact your Baxter sales representative to see how with change comes clarity.

Drug delivery from Baxter Healthcare Corporation.

Doing our part, so you can do yours.

pharmacy workďŹ&#x201A;ow I drug delivery I nutrition I iv access I infusion systems I support & service

Baxter is a registered trademark of Baxter International Inc.

Medication Delivery

111779 12/12

14 Clinical Section

Pharmacy Practice News • February 2013

Practice Pearl Subsection

HEP C continued from page 12

TF members spent in the clinic was optimized by having nurses, rather than nurse practitioners or clinical pharmacists, measure blood pressure and train patients on injections. Through service agreements, some facilities were able to expedite referral to psychiatry or infusion clinics, thereby enhancing access to care and reducing hospitalizations for blood transfusions. If needed, TF members from a sister facility could provide support by email.

Laboratory issues were universal to all the facilities—the HCV RNA limit was not low enough for response-guided therapy, and electronic reporting of the results was delayed. Support from the VISN pharmacy executive and the chief medical officer empowered the TF manager to collaborate with the VISN chief of laboratory and pathology to uniformly reduce the HCV RNA to the desired range and reduce the time for the results to be entered into the electronic medical record (EMR) at all the facilities. The ability to report HCV RNA in less than 2 weeks allows providers to identify quickly patients in whom treatment should be stopped. The reduction in the quantification limits of HCV RNA to less than 10 to 15 IU/mL assures the provider and patient that the treatment decision was evidence-based and supported by criteria for use of PIs. The TF identified a lack of uniform ADE reporting throughout the VISN 12 facilities. After consulting an expert at the VA’s national Pharmacy Benefit Management group for guidance, the TF identified realistic and achievable parameters to standardize ADE reporting. The number of reports increased from a baseline of 9 events in quarter 1, to 41 in quarter 2; the increase was maintained in quarter 3, making VISN 12 one of the highest-reporting VISNs in the country. A shared responsibility for increased reporting developed at several sites, when additional reactions were noted during medical record reviews.

To enhance knowledge and communication about the HCV therapy initiative, the TF manager encouraged clinicians to use available electronic knowledge-based tools (www.hepatitis.va.gov website; “ask the expert,” a live VA website that allows experts in the field to respond to questions; criteria for use of specific drugs; a drug-drug interaction tool). These standardized, evidence-based tools are updated nationally to maximize patient care throughout the VA system. Additionally, electronic consults allow providers to request PIs such as boceprevir using the EMR. This consult highlights appropriate criteria for use and helps identify candidates for treatment. For difficult-to-treat patients, clinicians coordinate with the TF manager to query experts outside the VISN, who offer data supporting

decisions and/or expert opinions.

Models of Care In the VA system, facilities are supported by national groups such as Pharmacy Benefit Management, the Hepatitis C Resource Center, and the Office of Public Health, which provide evidence-based guidance for disease management. Providers work locally at their individual sites and network periodically when attending meetings and speaking with colleagues.

Coordination of information within a

single VISN as well as with other networks and national groups is paramount in reaching providers and patients who are far from expert care and to allow optimized care using complex regimens.

The “Ferris wheel” model highlights the flow of information within a large network to provide an efficient method to improve and enhance delivery of information (Figure, page 12).

The complex care of patients embarking on PI-containing regimens can be standardized with regard to laboratory monitoring, ADE reporting, and access

to treatment tools. Disease state management is enhanced when clinicians have access to experts who can lend support and share experiences, providing clinicians with a much larger set of information from which to draw new ideas and solve problems. Clinical pharmacy subject experts are excellent conduits to bring clinicians and patients together to provide the best care anywhere, irrespective of clinic makeup or location.

we are

mobile!

PharmacyPracticeNews.com

On your phone Wherever you are Catch up on the latest news stories

It’s easy!

Use your mobile device’s browser to go to

pharmmacypracticenews.com Bookmark us on your homescreen When you see this application icon you are good to go!

Scan this code with your smartphone to visit Pharmacy Practice News mobile Web site.

Bookmark the site on your device to read Pharmacy Practice News on the go.

Dr. Bonner was formerly VISN 12 Chief Medical Officer.

Clinical 15 ISMP

Pharmacy Practice News • February 2013

NEONATES continued from page 9

liquid Methergine error occurred in Italy.

According to Dr. Cohen, the Novartis letter recommended preventive measures similar to those suggested in American Regent’s letter. It also added that if medications for the mother and the newborn cannot be stored in separate ADCs, medications intended for use in newborns should be placed in a locked, lidded storage bin and the selection screen should highlight which

ISMP warns that when treating obstetrical patients, action must be taken to avoid mistakenly injecting neonates with methylergonovine maleate instead of the similar-looking hepatitis vaccine, Engerix-B.

Medication Safety medications are for the mother and which are for the infant.

Novartis also noted that while some centers may not have the capacity to keep mothers and newborns in separate rooms, “many infants are initially evaluated in a newborn nursery setting, so administration of some medications after birth, including hepatitis B vaccine, may be delayed until the baby is in the nursery.”

Finally, Novartis urged that infants receive an identification bracelet immediately after birth to ensure that drugs

The Buyer’s Guide is always available at pharmacypracticenews.com

specialtypharmacycontinuum.com

ALWAYS AVAILABLE @ www.pharmacypracticenews.com www.specialtypharmacycontinumm.com

are administered with the use of barcode technology.

Plan Do Study Act Neonatal drug safety expert Kevin Sullivan, MD, an attending neonatologist in the Department of Pediatrics at Nemours Neonatology/Alfred I. DuPont Hospital for Children and the medical director of the Special Care Nursery at St. Francis Hospital, in Wilmington, Del., suggested that centers that have experienced errors like the methylergonovine maleate situation consider following the Plan Do Study Act (PDSA) protocol. This process, initially developed by the Institute for Healthcare Improvement, would help ensure that the American Regent and Novartis preventive strategies are effective, he said.

In a study led by Dr. Sullivan, a feedback program using PDSA cycles reduced narcotic prescription errors in a neonatal ICU by 83% ((BMJ Qual Safe 2012 Oct 4. [Epub ahead of print]). However, he said that monitoring and managing errors as severe as newborn methylergonovine maleate administration should not require an entire cycle. “Ideally, the significant measures suggested in the letter would reduce the possibility of this error; and when you study the results of the enacted plan, you would get the zero incidence that you are looking for,” he said. “You wouldn’t want to underrespond to the error and find in your ‘Study’ stage that you still have multiple errors to ‘Act’ on.” With the abbreviated cycle, clinicians would implement the preventive measures outlined in the American Regent and Novartis letters (Plan and Do) and monitor any changes and improvements (Study).

Pediatric clinical pharmacist Harlan Husted, PharmD, said he and his colleagues in the neonatal ICU at the Community Regional Medical Center, in Fresno, Calif., are changing the way they handle methylergonovine in light of the reported errors. “In our labor and delivery unit, we stock [the drug] in an ADC and have it available to nurse and physician staffers as an override-able medication, meaning they can remove it immediately without having a medication order verified by a pharmacist. Thus far, we have not had any mix-ups with the drug but are taking steps to have this medication removed from the override list.”

Dr. Husted said the change, if approved, will require a physician order to be verified by pharmacy staff before the drug is released from the ADC. Furthermore, pharmacy and other clinical staff will be briefed and made aware of the potential for the methylergonovine error. He urged other centers to do the same.

—David Wild Drs. Husted, Sullivan and Cohen reported no relevant financial conflicts of interest.

16 Operations & Management

Pharmacy Practice News • February 2013

Social Media

a-TWITTER

‘There’s so much that’s happening so fast in pharmacy, and particularly within health information technology, that a medium like Twitter is particularly helpful.’

continued from page 1

the Kardashians. Health h care providers, includingg pharmacists, are increassingly using Twitter professionally. Ms. Spiro was one of more than 500 attendees at ASHP MidM year who were tweeting items that they found intrigu uing or useful from the meetin ng, most of them using the hashttag #ashpmidyear. (See the “Gettting Started” sidebar if you don’t know w the difference between a hashtag and hash browns.)

—Rachelle “Shelly” Spiro, RPh, FASCP

‘When I get on Twitter, I connect with people in pharmacy, nursing, medicine, policy, research and informatics from around the world. It’s a much broader community.’

—Kevin Clauson, PharmD “Those 500 individuals generated almost 3,000 tweets,” said Colleen Bush, ASHP’s market research manager (@ mdgirl on Twitter). “We use a service that helps us measure the reach of social media like Twitter, and we were able to determine that about 160,000 people saw at least one tweet about our meeting.”

Many pharmacists, however, are just starting to become aware of Twitter as something they can use to make their jobs easier or to help their patients.

ASHP surveys indicate that about 25% of pharmacy students regularly use Twitter, whereas 22% of new practitioners and only about 12% of pharmacists who have been in practice longer do.

So, if you’re like the majority of pharmacists in practice—even the “next generation”—this means that you have not yet adopted Twitter professionally. Why should you? What good is it? Is it just another Internet fad?

That’s what Kevin Clauson, PharmD, an assistant professor of pharmacy practice at Nova Southeastern University and the director of the Center for Consumer Health Informatics Research, both in Fort Lauderdale, Fla., thought initially.

“I saw it as just another useless social media electronic time-sink,” he said. “But then they had the disputed elections in Iran in summer 2009, and the U.S. State Department actually requested that Twitter not shut down for its scheduled weekend maintenance because it was the only source of independent information about the elections. I thought, wow, if the State Department considers it an important source, there must be something here.”

A few months later, Dr. Clauson attended the Medicine 2.0 2009 conference, a meeting that focused on social

media, mobile apps and the Internet in health, medicine and biomedical research. “I saw how Twitter was being used professionally to integrate technology and health care by people attending that meeting, and I really got on board,” he said. Since then, Dr. Clauson (@kevinclauson) has become one of the more active pharmacists on Twitter, with nearly 1,700 followers and 3,800 tweets to date. Based on that experience, Twitter is “the single most useful professional communications tool I have,” he said.

That’s a pretty strong statement. How can a steady stream of 140-characteror-less commentaries beat out professional journals, societies and academic meetings? Because it’s all those things and more, Dr. Clauson said. “We can be guilty of being in a professional echo chamber, always hearing the same types of opinions and going to the same meetings. When I get on Twitter, I connect with people in pharmacy, nursing, medicine, policy, research and informatics from around the world. It’s a much broader community.”

Interested yet? If so, here are a few suggestions for steps you can take to maximize Twitter as a professional resource.

Filter information that can be used for maintaining current awareness. In other words, use Twitter to “curate” the endless fire-hose stream of information coming at you from all directions: journal articles, professional societies, departments of health, colleagues, public news sources and so on.

Rather than scanning and scouring five, eight or 10 professional and trade journals every month, if you develop a good

1

Twitter feed of reliable sources within your specialty, you’ll start getting alerted to the most interesting and relevant new articles the minute they post online. “By creating lists, filtering who I follow, and searching using different hashtags, I can pinpoint information and narrowly focus on what I’m looking for,” said Jerry Fahrni, PharmD, a product manager in pharmacy automation at Talyst, Inc. and a relative early adopter of Twitter (@jfahrni) who has 1,039 followers and has sent out well over 12,000 tweets to date.

Follow developments and ideas from pharmacy and 2 medical conferences via hashtags.

Can’t make it to #ashpmidyear? Just follow that hashtag and you won’t simply receive tweets from the society about the meeting, but also anything that your colleagues might find interesting— such as Ms. Spiro’s tweet on Bill Clinton’s collaboration with his community pharmacist.

Network and collaborate directly with other profes3 sionals working in your field. See someone tweeting about a topic that intrigues you? Send a direct message and open up a conversation.

Use Twitter as a tool for early detection of issues 4 within the pharmacy profession. “Twitter can be a potential early warning system,” Dr. Clauson said. “Before public health problems, issues of patient safety and so on start showing up in professional journals, you’ll start hearing about them in your Twitter feed.”

Engage with patients and the public—not just receiving, but also sending out tweets of your own. You can promote services and events at your pharmacy, share journal articles you find intriguing, or retweet messages—that is, repost another person’s tweet—that you’ve

5

Getting Started on Twitter: The Basics Sign up for an Account It’s pretty simple to get started on Twitter. The first step is to visit www.twitter. com and sign up for a free account and give yourself a Twitter username. Many people use some combination of their first and last names—like @kevinclauson.

You could also add your professional degree, like janedoepharmd. You can only use upper- and lowercase letters, numbers and the underscore character. Also, be sure to fill out the brief description of yourself in your profile; it’s a great way for people with similar interests to find and follow you.

Accessing Content There are a number of ways to read posts to Twitter, which are called “tweets.”

You can just go to the Twitter website and log in. You also can use applications called clients, some free and some purchased at a nominal fee, to help sort and manage your incoming Twitter feed and your own tweets. Some of the most popular are Twitterific, HootSuite and Tweetdeck; which one is best for you will depend on what kind of computer or mobile device you’re using it on.

You start filtering the information you get on Twitter in two basic ways: finding good sources to “follow”—which means subscribing to their tweets so that everything they post shows up in your Twitter “feed” (a list of recent posts)—and searching for terms that are of interest to you.

Following is simple. If you like someone’s tweets, just search for that person in your Twitter client and then select “follow.” Bingo—you’ve subscribed to that person’s tweets. Searching for terms of interest—like “pharmacy” or “pharmacist”—isn’t as straightforward as you might think. If you just go onto Twitter and enter “pharmacist” in the search window, you’ll get every single tweet that mentions that word—like the recent joke about how drug dealers should call themselves “exotic pharmacists.”

One way to fine-tune your searches for content on Twitter is to understand and use hashtags—that is, the # symbol in front of important terms in the message. For example, tweets about ASHP Midyear contain the hashtag #ASHPmidyear. If you want to search for tweets that are really relevant to pharmacy practice, rather than all those that happen to mention the word, use the # symbol before whatever word you’re searching for.

For more tips on getting started, see sidebar, “Setting Up Your Twitter Feed.”

And remember, Twitter itself can be of help; the site has tips for beginners at htttp:/support.twitter.com/groups/31-twitter-basics.

—G.S.

Operations & Management 17

Pharmacy Practice News • February 2013

Social Media

Setting Up Your Twitter Feed Sources for Pharmacy, Health Care and Health IT: @JFahrni – Jerry Fahrni, PharmD. What’s new in pharmacy and technology, especially tablets. @DrJeffCain – Jeff Cain, EdD, MS, University of Kentucky College of Pharmacy, Lexington. Top source on use of social media in pharmacy and education. @MeganPharmD – Megan Hartranft, PharmD, University of Michigan Health System, Ann Arbor. Documenting her journey from student to resident to ... @drwalker_rph – Dave Walker, RPh. Self-described “social media evangelist,” well-rounded source of information on medication therapy management and pharmacy practice.

Good Hashtags for Pharmacy-Related Content #pharmacy #pharmacist

@shellyspiro – Rachelle “Shelly” Spiro, RPh, FASCP. Pharmacy and health information technology.

#rx

@kevinclauson – Kevin Clauson, PharmD, Nova Southeastern University, Fort Lauderdale, Fla. Pharmacy and health informatics.

#MTM

@poikonen – John Poikonen, PharmD, University of Massachusetts Memorial Healthcare, Worcester. Clinical informatics expert and frequent blogger on pharmacy-related technology trends (www.rxdoc.org).

You can also build your hashtag list with specialty-specific terms, such as #pediatrics, #geriatrics, #diabetes, #oncology and so on.

@foxerinr — Erin Fox, PharmD, University of Utah Hospitals & Clinics, Salt Lake City. Drug shortage expert, key contributor to ASHP Drug Shortages Resource Center.

—G.S.

Organizations and Publications To Follow @ashpofficial @ashpfoundation @pharmacists (APhA) @medscapepharm @formulary_news @pharmacistsletter @PharmPracNews

You can also look for your state’s pharmacy association on Twitter—most state pharmacy organizations have a Twitter presence, and it’s a good way to track more local issues. The Missouri Pharmacy Association, for example, tweets at @thempa.

Lists To Follow Pharmacy by @poikonen https://twitter.com/poikonen/ pharmacy/members Pharmacy by @JFahrni https://twitter.com/JFahrni/ pharmacy/members

Suggested Reading 140 Health Care Uses for Twitter (by Phil Baumann, RN) http://philbaumann. com/2009/01/16/140-health-care-uses-for-twitter Ten Ways To Increase Your Twitter Followers (by Kevin Rose) http://m.techcrunch.com/2009/01/25/ kevin-rose-10-ways-to-increase-your-twitter-followers

@USFDAmedwatch

received. This is what you do with Twitter after you’ve been using it for a while. Ideally, to make the most of Twitter professionally, Dr. Clauson said, spend a couple of months just sitting back and reading your feed, finding good people in your area to follow and learning how it works. Then you can start tweeting messages of your own and encouraging people—whether they are colleagues, community members or patients—to follow you.

As with any new technology, adopt Twitter with caution. “I crept into

Twitter very slowly at first and watched what other people were doing for a while before I started sending my own messages,” Dr. Fahrni said. Remember, unlike Facebook, anyone can follow or find your posts on Twitter—you don’t have to “friend” them or set your privacy settings to the most open parameters imaginable before someone can read what you’ve posted. If you post something false, inflammatory or foolish on Twitter, it can easily be found by employers, patients and colleagues.

And it should go without saying, but

Follow us on

as with any other communications medium, health care professionals who use Twitter should never discuss any sort of personal health information that could run afoul of HIPAA. When used properly, Dr. Fahrni said, Twitter can be much more of a timesaver than a time-waster—in effect, a personally curated filter for professional news. “When I’m eating breakfast or having lunch at my desk, I’ll pull my phone out and scan through my Twitter stream,” he said. “I’m extremely picky.

I only follow about 200 people, and

every so often I’ll go through my feed and stop following the ones who aren’t of interest anymore. That way, I keep everything useful and relevant.”

“There’s so much that’s happening so fast in pharmacy, and particularly within health information technology, that a medium like Twitter is particularly helpful,” said Ms. Spiro. “Blog posts and articles can take a lot of time. Twitter forces you to distill everything down to a short blurb containing what’s most important.”

—Gina Shaw

18 Operations & Management

Pharmacy Practice News • February 2013

Critical Care

ED Pharmacists’ Value on Display at ASHP Midyear Las Vegas—The fluid environment of the emergency department (ED) creates persistent medication safety challenges: Medication reconciliation often is incomplete and inaccurate; verbal orders and interruptions during patient care are the norm; and patients are unfamiliar and their records incomplete. All of these factors are associated with heightened risks for drug errors and adverse events.

The following article describes presentations during the American Society of Health-System Pharmacists Midyear Clinical Meeting about four approaches to expanding ED pharmacist services that successfully address some ED medication safety challenges.

Starting With Med Rec Can Open the Door for ED Pharms Although the fast-paced environment of the ED presents heightened medication safety challenges and risks, fewer than 4% of EDs have consistent pharmacist involvement in patient care, according to a study from pharmacists in Ohio.

Sara Triglia, PharmD, an ambulatory clinical pharmacy specialist in the Family Medicine Center at St. Elizabeth Health Center, in Youngstown, Ohio, and her colleagues designed, implemented and evaluated a pilot program employing a clinical pharmacist in the ED to determine its effect on medication safety and efficacy, as well as costs.

Dr. Triglia spent one month in the ED and logged all interventions and associated patient care benefits and cost savings. Her primary outcome measure was the number of discrepancies avoided in the medication reconciliation process when it was performed by a pharmacist in the ED. Secondary end points included pharmacist interventions, recommendation acceptance rate, number of adverse drug events reported and prevented, cost avoidance and the perception of an ED clinical pharmacist by ED staff, as determined by a survey of physicians and nursing staff before and after the pilot period.

Dr. Triglia completed medication reconciliation for 71 patients, avoiding 802 discrepancies. Avoided discrepancies included 95 omitted medications, eight extra medications, 213 omitted doses, 221 omitted frequencies, 243 omitted routes, four wrong medications, six wrong dosage forms, three wrong doses and nine omitted allergies. Pharmacist intervention recommendations were accepted 96% of the time. The most frequent interventions were related to drug information, initial antibiotic choice, initial dose calculation and medication reconciliation. Total cost savings for the study period was calculated to be $21,494.

According to the survey results, the perceived value of pharmacy services in the ED improved during the one-month pilot. For example, the score for the survey item “pharmacy services improve quality of care in the ED” rose from 3.68 before the pilot to 4.5 (on a five-point scale), according to Dr. Triglia.

“When I took the results to hospi-

tal administration, they said, ‘this looks pretty good, why don’t we test it on a larger scale for six months,’ ” said Dr. Triglia. During that trial period, two full-time pharmacists were assigned to the ED. “They were able to provide enough documentation showing that they recouped their salaries in just three months, and now those ED pharmacist positions are permanent.”

Notwithstanding the reported economic and staffing gains that ensued from the initiative, Daniel Hays, PharmD, BCPS, FASHP, the clinical coordinator of emergency pharmacy services in the Departments of Pharmacy and Emergency Medicine, at the University of Arizona Health Network, in Tucson, said he still does not believe that medication reconciliation—which was central to the study’s primary outcome—is a good use of an ED pharmacist’s time. “It doesn’t require the expertise of a pharmacist,” he said. “A well-trained pharmacy technician can do it,” he said, adding that the majority of the other tasks conducted by pharmacists also could be done by a technician or performed remotely.

Dr. Triglia acknowledged the critique but explained that at the time of the study, the ED was still using paper charts and the medication reconciliation process was dysfunctional. “We

knew that administration would be dumbfounded by us showing them the amount of errors in our medication reconciliations, so we went this route to show a great tangible effect from the project,” she explained. Pharmacists currently assigned to the ED no longer perform medication reconciliation, and the department is planning on having pharmacy technicians take on the task. Pointing to the clinical services the ED pharmacists now provide, she added, “The physicians ask us to go see the patients physically in the ED, and we respond to all traumas and codes in person.”

Overnight ED Pharmacist Helps With Standards Compliance The 127-bed Providence Health and Services, in Centralia, Wash., followed a different path to expanding pharmacy services into the ED. Motivated chiefly by a desire to comply with Joint Commission standards calling for prospective review of all medication orders, the facility’s pharmacy stopped outsourcing its after-hours order reviews and stationed an overnight pharmacist in the ED. “We’re a small hospital, and about 85% of our admissions come through the ED, so it made sense to have the pharmacist work out of the emergen-

‘To cover 20 out of 24 hours a day is not only very impressive but very admirable.’

—Daniel Hays, PharmD

cy department,” said David Dietrick, PharmD, BCPS, an emergency department clinical specialist. The overnight pharmacist is responsible for hospitalwide services but also operates as a member of the ED’s clinical team.

Shortly after the staffing change, the ED staff requested a pharmacist’s presence in the department at all times, according to Dr. Dietrick. Their enthusiasm led to 20 hours of daily ED pharmacist coverage. “The ED has welcomed the presence of a pharmacist, and that’s very encouraging for us,” he said.

Dr. Dietrick and his colleagues also collected information on the clinical and financial effect of providing permanent pharmacy services in the ED. Over a 14-month period, ED pharmacists documented 10,875 interventions valued at more than $2.5 million (according to the monetary value assigned to various interventions by the hospital’s electronic medical record system).

Additionally, the volume of medication dispensed in the ED dropped significantly, resulting in an annual estimated savings of $11,300. Dr. Dietrick explained that ambulatory patients discharged from the ED often receive a day’s supply of prescribed drugs because there are no all-night retail pharmacies nearby.

“Many patients would have to fill their prescriptions the next day, so ED physicians typically sent them off with enough to cover 24 hours. But the hospital has to absorb the costs of those drugs.” The pharmacy determined that the stopgap medications were dispensed too freely and assigned more restrictive hours when they could be handed out.

A survey of non-pharmacy staff revealed that pharmacists had become an integral part of the ED medical team, Dr. Dietrick said. He pointed out that their expanded clinical role meant that they became more familiar with patients’ clinical findings and symptoms. “The presence of pharmacists has been greatly appreciated and has changed the dynamics of care and the interactions among the clinicians,” he said. Additionally, the pharmacists themselves reported greater job satisfaction as a result of their increased professional integration.

Dr. Hays complimented Providence Health for its innovative approach. “To cover 20 out of 24 hours a day is not only very impressive but very admirable,” he said. “It’s tough to pull off on a few levels: One is you never know when the ED is going to be busy, so how do you decide when to schedule those 20 hours? Also, it’s difficult finding pharmacists who are both interested in working those later hours and trained to fill the ED’s needs.”

•

see ED SAFETY, page 21

Operations & Management 21

Pharmacy Practice News • February 2013

Critical Care

ED SAFETY continued from page 18

ED Pharms Enhances Antimicrobial Surveillance An ED pharmacist-led antimicrobial surveillance program can optimize therapy and save physician time, according to a report from pharmacists at Northside Hospital, in Atlanta.

Because culture and susceptibility reports can take from 48 to 72 hours to complete, prescribers must rely on empiric antibiotic therapy decisions. In 2011, clinical pharmacists at the Northside Hospital ED established an antimicrobial surveillance program in which an ED pharmacist reviews all finalized culture and susceptibility reports daily and compares positive cultures with previously prescribed antibiotic therapy.

“For patients who received empiric therapy that matches the final culture reports, no further action is needed,” said Karen Biehle, PharmD, an ED clinical pharmacist at Northside. But if the prescribed antibiotic is not well matched to the bacterial infection, or if the pathogen turns out to be a drug-resistant strain, the pharmacist recommends a therapy change to the physician. If the recommendation is accepted, the pharmacist informs the patient by phone and calls the patient’s pharmacy to place the new order. “As soon as the labs come in, the calls go out,” said Dr. Biehle.

Dr. Biehle and her colleagues monitored the surveillance program for patients with urinary tract infections (UTIs), a common presenting complaint in the ED. Empiric antibiotic therapy for a suspected UTI often begins without the benefit of urine culture results.

Over a one-year span, ED pharmacists reviewed 541 positive urine cultures; of these, 143 patients (26%) required pharmacist intervention, including 102 patients who required a change in antibiotic therapy.

The reasons for antibiotic changes included 81 organisms resistant to the

‘I still encounter many providers who don’t understand the difference between sedation and comfort. This is another area where a pharmacist can have a big impact.’

—Erin Robey-Gavin, PharmD

empiric antibiotic ordered, seven organisms with intermediate susceptibility and 14 organisms that were not routinely tested for the antibiotic prescribed. Prescribers accepted all of the pharmacists’ recommendations for a therapy change.

Review and documentation of a single positive culture required approximately 15 minutes; it was somewhat longer if a therapy change was required. The researchers estimated that the surveillance program saved at least 170 hours of physician time.

“We get everything ready for the physicians, and they review our recommendation,” Dr. Biehle said. “We’ve had a big impact on the physician’s choice of therapy, and the program has been a great way to increase pharmacists’ visibility in the ED.” Antimicrobial stewardship in the ED not only saves time for physicians, it also “provides the best and most accurate treatment,” noted Dr. Hays, adding that too often, the follow-up actions such as those documented by Dr. Biehle and her colleagues are not done at other facilities.

ED Pharmacists in Chicago Enhance Pain Management After a Chicago hospital initiated clinical ED pharmacy services in October 2010, the pharmacists there learned that intubated patients nationwide frequently don’t receive adequate pain control after their procedures.

“We found in the literature that less

than half of patients in the ED who undergo rapid-sequence intubation receive analgesia, and dosing is adequate in only 25% of cases,” said Erin Robey-Gavin, PharmD, BCPS, an emergency medicine clinical pharmacist at Mercy Hospital and Medical Center.

The analgesia administration rates at Mercy turned out to be even lower: In early 2010, only 20% of patients received an analgesic along with a sedative.

Dr. Robey-Gavin and a colleague conducted a series of interventions designed to increase the rate of post-intubation analgesia. The specific interventions included stocking premixed fentanyl infusions in the ED’s automated dispensing cabinet (which made the drug readily available and obviated the need for a nurse to travel to the central pharmacy to obtain it), and regularly reminding ED providers that the fentanyl was on hand. They also educated physicians and nurses about the importance of postintubation analgesia, offered pharmacologic reviews of sedatives and analgesics commonly used for intubated patients, which covered fentanyl’s hemodynamic effects and safety profile and provided information about compatibility of analgesics and sedatives, as well as dosing and titration recommendations.

A retrospective review of adult intubated patients—41 in the preintervention group and 41 in the postintervention group—showed that the rate of analgesia more than doubled postintervention, ris-

ing to 49%. Dr. Robey-Gavin observed that 85% of analgesia administration occurred during cases when an ED pharmacist was on duty (10 a.m. to 8 p.m.).

“That suggested it was our direct presence that served as a reminder to use fentanyl with the sedative regimen,” she said. An informal query of the ED clinical staff confirmed her impression: “They told us that when a pharmacist is here, they think more about pain control.”

Dr. Robey-Gavin also noted that assessing pain levels in intubated patients is difficult, which is why the study examined only whether or not analgesia was administered, not its adequacy. “It’s hard to evaluate patient pain when they’re under sedation, and particularly difficult if they’re oversedated,” she said. “We’ve done a lot of education about pulling back on the sedation a little bit to see how patients react. You can tell a lot by simply observing their body language during procedures.” Moving away from sometimes unreliable physiologic markers such as heart rate and blood pressure to evaluate pain, and increasing the use of nonverbal pain scales, is the next step, she added. “I still encounter many providers who don’t understand the difference between sedation and comfort. This is another area where a pharmacist can have a big impact.”

Dr. Hays agreed that this was an important area for pharmacists to play a role.

“This is something that pharmacists need to be doing,” he said. “With the trend toward more frequent use of nondepolarizing paralytics, which last much longer than standard depolarizing paralytics, I think physicians often forget about analgesia, and they risk having a patient who is paralyzed but wide awake and completely aware of what’s going on.”

—Steve Frandzel Drs. Triglia, Hays, Dietrick, Biehle, and Robey-Gavin reported no relevant financial conflicts of interest.

NEW PRODUCTS

New Pharmacy Automation From McKesson

M

cKesson High Volume Solutions (HVS) has launched an all-new ExpressRx Track™ pharmacy automation solution, featuring state-of-the-art robotics, upgraded imaging and expanded vial capabilities, and industry-leading speed and accuracy in a radically small footprint with flexible payment options, the company stated in a press release.

The automated conveyor-based pharmacy has one of the smallest footprints and highest accuracy of any solution

on the market, the company added.

“The completely redesigned ExpressRx Track sets a new standard in performance and scalability, automating 95% of all countable prescriptions at 99.99% accuracy for ExpressRx Track users.” ExpressRx Track “also includes…new pill image features and supports a unified drug photo library, so that verification pharmacists can more seamlessly verify filled prescriptions within your operation.”

For more information, visit http://www.mckesson.com.

AHP Expands Unit-Dose Line

A

merican Health Packaging (AHP) has added three new products to its growing unit-dose line: Hydrocodone/APAP 7.5 mg /325 mg CIII tablets (AB-rated to Norco®); Oxybutynin 10 mg ER tablets (AB-rated to Ditropan-XL®); and Trazodone HCl 150 mg tablets (AB-rated to Desyrel®).

AHP now offers more than 380 SKUs, many of which are industry exclusives, the company noted in a press release. “These unit-dose launches are part of an ongoing

commitment to support health systems’ BCMA [barcode medication administration] initiatives, while promoting efficiency in pharmacy operations. All AHP unitdose items are bar coded to the dose level and feature an extended shelf life.

In addition, our cartons feature colorcoded labels with “tall man” lettering to more easily distinguish them in the pharmacy prior to dispensing.”

For additional information, visit americanhealthpackaging.com.

22 Operations & Management

Pharmacy Practice News • February 2013

Practice Models

Hospitals Keeping a Foot on the PPMI Pedal Las Vegas—Hospitals are starting to see the results of ambitious efforts to implement the principles of the Pharmacy Practice Model Initiative (PPMI) into their culture and operations. OSF Saint Francis Medical Center, in Peoria, Ill., and the Cleveland Clinic Florida, in Weston, were among the centers presenting their successful PPMI projects during the American Society of Health-System Pharmacists Midyear Clinical Meeting.

Implementation of key PPMI precepts triggered a major realignment of pharmacy resources at the 616-bed Saint Francis Medical Center, lead-

model change. They recorded a 21.6% increase in the number of monthly pharmacist interventions, from 5,393 to 6,557, on average. The most frequent interventions included lab follow-up recommendations, order clarification, pharmacokinetic and warfarin dosing consults and antibiotic stewardship.

Using software that assigns monetary values to clinical interventions, the researchers estimated cost savings of more than $290,000.

The concurrence of two events accelerated the pharmacy’s swing toward decentralization: the closure of a satellite pharmacy that served critical care

tionships with other interdisciplinary team members,” said Mr. Storm. “Overall, the demand for our services has increased. Nursing … has continually expressed their desire to have a pharmacist present on the floors.”

Mr. Storm added that the adjustments took time, particularly for pharmacists and technicians who had worked in the satellite. “Some of them felt a real ownership of the critical care pharmacy,” he said. “When it closed, they felt like they were losing their professional homes.

Now, I don’t know of a single pharmacist who wants to go back to the way things were.”

‘Our thought was that by having clinical generalists participating in patient rounds and providing individual medication counseling sessions with each patient assigned to their floor, they were bound to have frequent contact with patients, which we could leverage to increase patient education and satisfaction.’

—Amanda Brahim, PharmD, BCPS

ing to expanded use of automation, increased pharmacist decentralization and more clinical interventions.

The pharmacy documented the effect of those interventions and used the information to support its case for further growth of clinical pharmacist activities at the tertiary care center, said Ed Rainville, MSPharm, clinical coordinator. “Using our electronic medical record [EMR], we incorporated pharmacist interventions into the standard care process, and we document each time a pharmacist conducts patient care activities,” he said.

Mr. Rainville and his colleagues compared two six-month periods, one before and one after the practice

areas, and staff reductions in the main pharmacy caused by increased verification of drug orders by decentralized pharmacists, said pharmacy director Jerry Storm, BSPharm. Pharmacists displaced from the satellite and central pharmacies were repositioned to various hospital units and began participating in multidisciplinary patient rounds.

“They [are] now much more involved in clinical decisions,” said Mr. Storm.

The evolving model is in keeping with the PPMI’s emphasis on direct contact between pharmacists and patients, and it has raised awareness of the role of clinical pharmacists among other providers at the hospital. “It has allowed our staff to build rela-

“This is a well-directed implementation of a practice model change toward more patient-centered care, followed by an assessment of the results,” said Steve Nelson, BSPharm, MS, the director of the Center on Pharmacy Practice Advancement at the ASHP. “While an increase in the number of interventions is not a direct measure of improved patient care, it certainly has been used as an indirect measure.”

Adjusting Workflow Enhances Reach of Pharmacists At the 150-bed Cleveland Clinic Florida, a new standardized, electronic monitoring and documentation system supported a comprehensive shift in the

hospital’s pharmacy practice model.

“We created a new workflow where pharmacy services could better provide patient-centered care. Our goal was to have every patient receive medication counseling from a pharmacist in the hospital,” said Darshika Patel, PharmD, BCPS, a clinical informatics pharmacist.

The restructuring moved away from the previous emphasis on specialty care, in which pharmacists were primarily responsible for the clinical services in their respective specialty areas (e.g., nutrition support or anticoagulation), toward a more generalist approach. Pharmacists, regardless of their specialty training and certification, were assigned to hospital units and expected to assume full responsibility for medication management of all patients.

To facilitate the transition, the pharmacy dispensed with paper-based records as well as any electronic tools that were not consistent or shared among the staff and introduced a standardized electronic monitoring and documentation tool, according to Dr. Patel. One function of the tool prioritizes patients who are scheduled for discharge and alerts pharmacists to visit them for discharge counseling that includes a discussion of discharge drug regimens. Patients are also offered the option to have their prescriptions processed and delivered by discharge technicians to their bedside before discharge. Discharge technicians also are responsible for completing any insurance prior authorizations and addressing other insurance-related concerns to ensure that patients have all their medications before leaving the hospital.

The EMR now allows pharmacists to record patient progress notes as well, avoiding replication or confusion that had frequently occurred with paperbased records. “Through the EMR, the pharmacist can see exactly what clinical tasks have been completed for a patient that day and identify any outstanding or new tasks,” said Dr. Patel.

For example, if a pharmacist adjusts the vancomycin dose of an ICU patient who then transfers to a general care floor, the EMR displays that, and any other therapy changes and dosage trends, on a clinical “dashboard” that covers the patient’s entire hospital stay.

Dr. Patel’s team tracked the change in the number of monthly pharmacist interventions before and after the practice model transition. The mean number of monthly interventions increased from 3,126 before to 4,322 after; the mean number of interventions per patient-day increased from 0.84 to 1.14.

“This is another example of the

Operations & Management 23

Pharmacy Practice News • February 2013

Practice Models ‘While an increase in the number of interventions is not a direct measure of improved patient care, it certainly has been used as an indirect measure.’

—Steve Nelson, BSPharm, MS pharmacy moving toward a patientfocused model and making a concerted effort to assess the impact of that change after moving from a cumbersome paper-based process to an electronic process,” said Mr. Nelson. He added that he hopes the researchers go a step further and assess other effects of the changes, such as on Centers for Medicare & Medicaid Services (CMS) core measures and the number and types of adverse drug events. Dr. Patel said that those types of measurements are in their plans. “We haven’t measured those outcomes yet, but we are planning that next.”

Another group of investigators at the Cleveland Clinic found that practice model shift led to other measurable effects, including a sharp decrease in 30-day readmission rates for patients with chronic heart failure (CHF) and an increase in Hospital Consumer Assessment of Healthcare Providers and Systems survey (HCAHPS) scores related to medications.

“We specifically set out to reduce readmission rates and see if we could influence our HCAHPS scores,” said clinical pharmacist Amanda Brahim, PharmD, BCPS. “Our thought was that by having clinical generalists participating in patient rounds and providing individual medication counseling sessions with each patient assigned to their floor, they were bound to have frequent contact with patients, which we could leverage to increase patient education and satisfaction,” she said.

Pharmacy students and residents were used as “pharmacist extenders” to help counsel and triage patients.

As part of the practice model change, all patients admitted with CHF as a primary or secondary diagnosis received intensive inpatient pharmacist discharge counseling and disease-specific patient education material. Additionally, pharmacists made weekly followup phone calls to assess medication adherence and monitor for signs and symptoms of decompensation. Patients requiring intervention received specific instructions or were referred to a cardiologist for an outpatient visit.

A comparison of 30-day readmission

rates and patient satisfaction scores before and after the practice model change revealed that all-cause readmission rates remained about the same, but the mean CHF readmission rate declined by 15.6% ((P=0.04). From Sept. 1, 2011 through Jan. 30, 2012, pharmacists reached 106 CHF patients at home by phone. One out of five required additional intervention beyond education reinforcement. The HCAHPS medication-specific score improved in four of the five months under study.

“We put a lot of focus on CHF

patients. Each one gets an additional 30-minute lesson specifically about their disease state, plus written material,” said Dr. Brahim. “That reinforcement and the follow-up phone calls made a difference.”

Dr. Nelson agreed that through these types of efforts, “pharmacists can make a difference in terms of CHF readmission.”

All three studies, he added, reflect a larger trend toward a more generalist approach to pharmacy practice through greater decentralization of staff. “National data show that there’s

a movement away from the clinical specialist model and toward the clinical generalist model [[Am J Health Syst Pharm 2010;67:542-558]. Hospitals are striving to provide greater continuity of clinical services throughout the week, and that’s more difficult to accomplish under a specialist model.”

—Steve Frandzel Mr. Rainville, Mr. Storm, Mr. Nelson, and Drs. Patel and Brahim reported no relevant financial conflicts of interest.

Accurate, Safe, Sterile Drug Compounding Automation

Right at Your Fingertips

Introducing the first user-controlled automated compounding system for the safe preparation, reconstitution, and delivery of hazardous drugs.

The Diaana system lets you reduce the risk of exposure to hazardous drugs w while helping to maintain the sterility of the mix and minimize physicaal stress to pharmacists and technicians. Using many of ICU Meedical’s clinically proven ChemoClave™ needlefree closed system components, Diana fits under the hood of your existing biological safety cabinett to protect clinicians from exposure to hazardous drugs and accidental needlesticks, while protecting the final patient preparation

Diana

from exposure to environmental contaminants.

™

Hazardous Drug Compounding System

Contact us to see how to put accurate, safe, sterile automated compounding to work for you today.

Needlefree > Easy to Use > Less Waste > Lower Cost ©2013 ICU Medical Inc.

800.824.7890 | go.icumed.com/dianaPPN

24 Operations & Management

Pharmacy Practice News • February 2013

Finance

SMART SAVINGS

Part 2 of a Two-Part Series

By the NUMBERS

continued from page 1

ed in an initiative at the Medical University of South Carolina Transplant Center, in Charleston. By shifting the timing and location of antirejection drug infusions for kidney transplant patients, the university reduced its cost of care by tens of thousands of dollars, while maximizing Medicare reimbursements.

The key to the effort was the use of marginal kidneys (also called extended criteria kidneys)—organs that have ve suboptimal characteristics but st ill are suitable for transplantation under the right circumstances. The growin ng demand for kidney transplants, com mbined with a shortage of transplan ntable organs, has led to greater use of marginal kidneys, according to David d Taber, PharmD, an assistant professor and the director of clinical research in the Division of Transplant Surgery. “A few years ago, these organs wouldn’t have been accepted for transplantation, but wee don’t have enough donors for all th he recipients on the list,” Dr. Taber saiid.

“People are waiting longer and longger and we’ve had to push the margins of what we would accept.”

Marginal kidneys usually function adequately and often are transplanted into older recipients. Frequently, however, the organs take time to resume full function and are more likely to be rejected by the recipient. That means that, in many cases, recipients require higher levels of induction agents, such as antithymocyte globulin (ATG) and basiliximab (Siumulect, Novartis) than those who receive nonmarginal kidneys.

“When you combine the high cost of these drugs with the longer hospital stays and closer follow-up care necessary for recipients of marginal kidneys— and the fact that most reimbursement for transplants comes from Medicare and is based on Diagnosis Related Group (DRG) calculations—it pushes transplant centers into a financial quandary and puts a lot of pressure on them to maintain their economic viability,” Dr. Taber said. “We’re going to get paid the same amount of money no matter how long a patient stays in the hospital.”

He and his colleagues evaluated the economic and clinical effects of shifting the administration of the first postoperative ATG infusion to the outpatient setting, where the cost of the drugs would be less expensive because of Public Health Service pricing rules, and the hospital can recover higher reimbursement because the charges are not constrained by the DRG restrictions that apply to inpatient treatment.

The researchers prospectively followed a control group of 146 transplant patients who received standard

‘[DRG-based reimbursement] pushes transplant centers into a financial quandary and puts a lot of pressure on them to maintain their economic viability.’

The cost benefits of switching from inpatient to outpatient ATG therapy

$860 Per-patient cost savings per day

$1,856 Per-patient revenue increase per day

—David Taber, PharmD

$57,800 Savings from shorter hospital length of stay

$230,867 Total savings over study ATG, antithymocyte globulin

ATG dosing, and 85 patients whose day-of-discharge day of discharge ATG infu infusion was delayed until several days after discharge and administered in the outpatient clinic. Dosing was adjusted accordingly, said Dr. Taber. Because all transplant patients stay close to the hospital for some period after discharge

(in a hotel, if they don’t live in the area) aand must return daily for ou outpatient clinic visits anyway, the new protocol did not create any additional burden.

The researchers found that shifting day-of-discharge dosing to the outpatient setting resulted in per-patient cost savings of $860 per day and a

Automated Anesthesia Carts Save Hospital Nearly $900,000 Annually LAS VEGAS—Implementing an automated anesthesia dispensing system enabled another hospital system to reduce costs—in that case, via improved inventory management, medication charge capture and patient safety in surgical suites.

“We wanted to make sure that the medications administered to the patients are documented accurately in the medical record for patient safety and the hospital captures appropriate reimbursement,” said Christine Hong, PharmD, the pharmacy manager/medication safety officer at the Yale-New Haven Hospital, Saint Raphael’s Campus in New Haven, Conn.

Before employing the automated system, a manual billing process was used.

An evaluation of manual charge capture for 324 surgical cases (inpatient and outpatient) over five days revealed a charge loss of $6,570 ($1,314 per day).

Extrapolation to a full year equated to a loss of more than $427,000—nearly 40% of the pharmacy’s annual anesthesia medication purchases and about 8% of the total pharmacy budget.

“We found that approximately 20% of billing forms were completely lost, and the hospital wouldn’t get paid for those,” Dr. Hong said. “We also want to ensure that patients are being charged appropriately.”

Thirty-seven automated anesthesia-dispensing carts were installed, covering all operating rooms (ORs) and procedural areas. About 80 surgical procedures are performed daily in the main OR alone. During a four-month period after implementation, the new protocol led to an average daily increase in outpatient gross revenue of $8,700—the annual equivalent of about $696,000. There was also a one-time inventory savings of $11,500 from the reduction of duplicate anesthesia trays.

“We are continuing to monitor the utilization to determine the rate of stockout and refill to optimize inventory control, work-flow efficiency and safe anesthesia medication management,” Dr. Hong said. Nurse anesthetists are now able to spend more time with the patients because the medications are readily available from the automated dispensing system in the OR, she added.

—Steve Frandzel

mean per-patient revenue increase of $1,856—a total gain of $2,716 per patient. The new protocol also resulted in shorter hospitalization (3.1 vs. 3.9 days; P<0.001), which translated to an estimated savings of $57,800. The total net margin increase over the 18-month study period was $230,867.

One-year patient graft survival rates were similar between the groups.

The rates of infectious complications, including cytomegalovirus syndrome or disease, BK viremia and BK nephropathy, were comparable, as were readmission rates.

“We’ve demonstrated pretty convincingly that we can achieve reductions in the costs associated with these drugs,” Dr. Taber said. “We’ve also demonstrated that we’ve reduced the number of patients whose discharges are delayed.”

The program has been expanded to include additional high-cost antibody preparations, including basiliximab, rituximab (Rituxan, Genentech) and IV immunoglobulin, with a focus on giving all appropriate doses in the outpatient setting.

Cutting the Cost of COPD Therapy Pharmacists at Nanticoke Memorial Hospital in Seaford, Del., reduced drug costs and waste by substituting ipratropium via common canister protocol in place of the more costly tiotropium (Spiriva HandiHaler, Boehringer Ingelheim/Pfizer) for patients with chronic obstructive pulmonary disease (COPD).

The institutional-size tiotropium dry powder inhaler contains five doses—often more than required for the

Operations & Management 25

Pharmacy Practice News • February 2013

Finance average COPD patient’s hospital stay.

Frequently, fewer than half of the doses of inhaled tiotropium are used before patients are discharged, and because the drug is a dry powder, it cannot be used with a common canister, said Merideth Moody, PharmD, BCPS, a clinical pharmacist at Nanticoke Memorial Hospital.

“We were dispensing individual tiotropium dry powder inhalers to every patient, many of whom were only here for one or two days,” Dr. Moody said.

“There was a lot of wasted medication left in the inhalers.” Now, patients receive an individual spacer that can be used with the ipratroprium metered dose inhaler by multiple patients until its contents are exhausted. Respiratory therapists teach patients how to use the device and about the medication, and clinicians are instructed to take adequate steps to prevent cross-contamination.

“Our primary goal was to cut down on the waste of the tiotropium from doses that were lost or not used when a patient was discharged,” Dr. Moody said. “We hypothesized that if we could do a therapeutic substitution for all tiotropium patients and put them on a different anticholinergic bronchodilator that can be used with our common canister protocol, it would bring significant savings.”

Ipratropium, a short-acting bronchodilator, was selected as the substitute for tiotropium, a long-acting bronchodilator. Given that difference in length of action, the substitution is only suitable while the patient is hospitalized, after which they revert to the broncho-

dilator they used at home.

Their plan was implemented, and ipratropium delivered through common canisters has become standard. To determine the effect of the change, the researchers retrospectively identified the number of patients who received tiotropium and the number of wasted doses over a four-month period, then calculated the cost savings of substituting common canister ipratropium.

The total cost of wasted tiotropium doses exceeded $8,500. When the lower cost of common canister ipratropium was

factored in, cost savings totaled $13,740.

The authors added that the true economic implications should be assessed by the difference Scan here for in cost per patientPart 1, “Smart day of drug expenStrategies for ditures to account for increased costs Savings Presented associated with pro- at ASHP Meeting” viding individual inhalers to patients.

In 2009, the Institute for Safe Medica-

tion Practices commented on common canister protocol. Although it offered no definitive recommendations, the organization emphasized the risk for cross-contamination and the need for stringent adherence to infection control practices if common canisters are used (http://www.ismp.org/newsletters/acutecare/articles/20090409.asp).

—Steve Frandzel Drs. Taber, Moody and Hong reported no relevant conflicts of interest.

Medication Regimen Assessment: A new vital sign.

ACT NOW to continue receiving your FREE print subscription to Pharmacy Practice News!

Introducing MedSnap ID, a breakthrough app that uses your iPhone’s camera to provide easy visual pill identification and interaction screening.

To see how it works, stop by one of our Live Demos at HIMSS 2013, or watch our video at You can renew your subscription online by visiting http:// www.pharmacypracticenews.com/ renew and filling out a brief form.

You can also access the form by scanning the QR code above with your smartphone.

medsnap.com.

Snap it. / Check it. / Track it. / Share it.

26 Policy

Pharmacy Practice News • February 2013

Industry News

Teduglutide Approved for Short Bowel Syndrome

O

n Dec. 21, the FDA approved teduglutide (Gattex [rDNA origin] for injection, NPS Pharmaceuticals, Inc.) to treat adults with short bowel syndrome who are dependent on parenteral support, according to an FDA press release. An injection administered once daily, teduglutide helps to improve intestinal absorption of fluids and nutrients, reducing frequency and volume of parenteral nutrition.

The safety, efficacy and tolerability of teduglutide were evaluated in two randomized, placebo-controlled, clinical trials and two extension studies. Designed to quantify the number of patients who achieved

at least a 20% reduction in the volume of weekly parenteral nutrition after 20 and 24 weeks of treatment (clinical response), the clinical trials showed that 46% and 63% of patients, respectively, treated with teduglutide achieved a clinical response compared with 6% and 30% of patients treated with placebo.

The most common side effects of teduglutide identified in clinical trials were abdominal pain, injection site reactions, nausea, headaches, abdominal distension and upper respiratory tract infection.

A postmarketing study is required to evaluate teduglutide’s potential increased risk

for colorectal cancer and other conditions.

Ken Fujioka, MD, of the Nutrition and Metabolic Research Center at Scripps Clinic, Del Mar, Calif., said that, based on the debilitating nature of short bowel syndrome, the new approval will be a welcome addition to currently available therapies.

“In addition to serious medical complications, [these] patients can have socially restricted lives,” he said in a press statement. “Long infusion periods often disrupt sleep for patients. This is coupled with constant concern about using restrooms, as many patients will need to use the bathroom up to 25 times a day, or having an

accident with unpredictable diarrhea.

Other patients that have an ostomy bag have a fear of an ostomy bag leakage.

These factors leave many patients unable to socialize or work.”

Given the efficacy data on Gattex, he noted, the drug “may become a cornerstone therapy in the management of short bowel syndrome.”

In a press release from NPS, the company pointed out that teduglutide—a novel, recombinant analog of human glucagon-like peptide 2, a protein involved in rehabilitation of the intestinal lining— is the first major long-term treatment advance for short bowel syndrome in nearly 40 years.

NPS plans to make Gattex available in the first quarter of 2013.

For more information, visit www.gattex.com.

New Patent For CutisPharma

C

Now available for download:

Immune globulin comparison chart Developed for the iPad Sponsored by

From the publisher of

pharmacypracticenews.com

Scan the QR code above or visit www.pharmacypracticenews.com to download the app.

utisPharma, Inc., announced that the United States Patent and Trademark Office has issued a patent (US 8,276,757 B2) for a method for the preparation, storage and dispensing of compounded suppositories.

“The FIRST® container (suppository mold) and the method for suppository compounding is user-friendly and time saving for a pharmacy,” according to a company press release. “The FIRST® suppository mold is also customer friendly because the take-home molds are especially designed to not only maintain the integrity of each suppository once compounded, but also provide convenient patient dispensing.”

“The goal for CutisPharma and our FIRST® Kits is to meet the ‘Golden Rule’ of compounding, which is one prescription from one prescriber for one patient, and our FIRST® Kits will help pharmacies meet this goal,” said Dr. Indu Muni, founder, chairman and CEO of CutisPharma, Inc. “The use of FIRST® Unit-of-Use Prescription Compounding Kits facilitates compliance with United States Pharmacopeia (USP) Chapter <795>,” he added.

FIRST® products save dispensing time and can be compounded by the pharmacist while the patient waits, increasing customer satisfaction. Using FIRST® Kits, the pharmacist can compound a prescription faster than those prepared in the conventional way. A single NDC number assigned for the entire Kit facilitates the third party reimbursement process, and reduces audit-related adjustments.

CutisPharma now has 20 proprietary prescription compounding kits on the market: five progesterone suppository compounding kits, two testosterone kits, one hydrocortisone kit, six Magic Mouthwash kits, three omeprazole suspension kits and three lansoprazole suspension kits. The company has several more compounding kits in the planning stages.

For more information, visit www.cutispharma.com.

Based on a press release from CutisPharma, Inc.

The bookstore division of

MCMAHONMEDICALBOOKS.COM An Online Bookstore

ORDER BOOKS ONLINE

THE BOOK PAGE PUBLISHER’S TOP PICKS OF THE MONTH ON MCMAHONMEDICALBOOKS.COM These books and thousands more...

1

1

2

3

4

5

6

7

8

Art, Science, and Technology of Pharmaceutical Compounding

Loyd V. Allen; American Pharmacists Association Staff July 31, 2012

Scan here for our complete catalog of medical books.

ORDER ONLINE For pricing, a more complete review and easy ordering with a credit card, go to McMahonMedicalBooks.com.

We can supply any medical book in print, so if you don’t find the book you want, email your request with billing information to RMcMahon@McMahonMed.com.

If you are an author and would like your medical book featured in this book section, contact Ray McMahon, Publisher, at RMcMahon@McMahonMed.com.

This book presents in a logical and progressive format all the information that pharmacists and student pharmacists need to understand the purpose and processes of compounding. It covers basic guidelines, economic and technical factors that compounding pharmacists must consider and all aspects of good manufacturing practices for compounded medications.

2

Essentials of Pharmacy Management: Second Edition

Dennis Tootelian October 31, 2012 This book will provide those who aspire to become managers in healthcare organizations with a foundation of how to manage in an environment that is focused on “the business of healthcare.” Special features include cases that allow students to apply what they have learned to business situations within the context of various practice settings.

3

Handbook on Injectable Drugs: 17th Edition

Lawrence A. Trissel, FASHP October 31, 2012 With a 35-year track record, the Handbook on Injectable Drugs s is the premier reference for compatibility, stability, storage and preparation of parenteral drugs. The 17th edition is completely updated and peerreviewed with new monographs, new references, additional information and the latest guidelines—essential for your confidence as a professional who makes critical decisions on a daily basis.

4

Internal Medicine: A Guide to Clinical Therapeutics

Monica L. Miller; Rebecca L. Attridge; Rebecca Moote; Laurajo Ryan December 26, 2012 This peer-reviewed guide highlights important treatment options for the most common diseases managed by clinicians practicing in interr nal a medicine. ed c e

5

Managing Anticoagulation Patients in the Hospital: The Inpatient Anticoagulation Service

Michael Gulseth June 15, 2007 The first guide to providing systematic anticoagulation care in inpatient settings, this resource will be welcomed by all pharmacists who practice in or are developing, implementing and maintaining an inpatient anti-coagulation service.

6

Pharmacy and the US Healthcare System: Fourth Edition Michael Ira Smith; Albert I. Wertheimer; Jack E. Fincham

March 13, 2013 This book is a one-stop textbook of current information about the features of the US healthcare system. It covers the personnel and institu-tions, along with concise reports on trends, regulations policy and finance.

7

Stockley’s Drug Interactions Pocket Companion 2013 Karen Baxter, Claire L Preston

January 10, 2013 The conveniently sized quick-reference Stockley’s Drug Interactions Pocket Companion 2013 3 continues to provide the busy health care professional with a trustworthy, affordable and practical clinical reference on drug interactions and their management. It draws on the wealth of clinically evaluated, evidence-based information on drug–drug, drug–– herb and drug–food interactions that is presented in the latest revali-dated updates of the full reference work, Stockley’s Drug Interactions.

8

The APhA Complete Review for Pharmacy, Ninth Edition American Pharmacists Association

January 15, 2012 The NAPLEX® is the standard licensing exam that all U.S. pharmacy stu-dents must pass to practice pharmacy. It’s an arduous exam that tests a daunting range of knowledge. This book contains only the information most ost relevant e e a t to the t e exam, e a , summarized su a ed in abbreviated abb e ated bullet bu et format. o at PPN0213

28 Technology

Pharmacy Practice News • February 2013

Automation

Hospital Scores a First—IV Prep and EHR Integration T

he process of preparing and administering IV medicatio ons was not as efficient or as safe as WellSpan Health wanted it to o be back in 2009. There were many issues, but the crux of the problem was that pharmacy staff charged with IV infusion preparation had little control over the manual production process, and

nurses had little to no insight into how pharmacy manageed the medications.

That disconnect caused ffrequent disruptions in workflow, raised additional efficiency concerns, and perhaps most importantly raised the risk for drug administration errors, according to Chip Gerhart, RPh, the medication safety officer at WellSpan York Hospital, one of three facilities operated by York, Pa.based WellSpan Health.

Mr. Gerhart and his colleagues didn’t waste much time in finding a solution to their infusion problems. In July 2010, following an earlier pilot launch, WellSpan says it became the first health system in the world to implement an integrated automated infusion management system, choosing infusion pumps that could connect with their patients’ electronic health record (EHR). Today, the system is in place in a coronary care unit, a trauma surgery ICU and a 60-bed step down area for cardiac patients, and covers a total of 90 beds.

Speaking during a webinar on the rollout presented on unSummitU.com, Mr. Gerhart and Sharon Muller, RN, MSN, the coordinator of nursing informatics at WellSpan Health, discussed the limitations of the hospital system’s previous infusion devices and reported the benefits realized since the switch to an EHR-integrated model of infusion management.

Too Many Cooks in the Kitchen Before the rollout, WellSpan relied on nurses, pharmacists and pharmacy technicians to produce its continuous infusions. Under that scenario, nurses, who are frequently very busy tending to the various needs of multiple patients, were required to monitor the status of titrated infusions and reorder the infusions from the pharmacy on an “as needed” basis. “In our ICU setting, the reorder process often broke down and we would receive frantic phone calls that the medications were running out in five minutes, or worse, had already run out and the medication was needed immediately,” Mr. Gerhart said. “That meant dropping everything to make and deliver the infusion to the ICU.” Even when the process worked as

Physician’s orders, smart pump technology, bar coding and EHRs are all integrated in a recent technology rollout at WellSpan Health.

‘The real-time streaming data give you a situational awareness that allows you to make clinical decisions based on accurate, actionable information.’

—Sharon Muller, RN, MSN expected, he added, “every reorder notification had to be handled by a pharmacist. The end result was a disruption to the workflows of both the pharmacist processing the reorder and the nurse tasked with sending the notification.”

The new integrated infusion management system, in contrast, uses a variety of connected technologies to create transparency surrounding the reorder process for both pharmacy and nursing. “We use Cerner’s infusion management product

Infusion Management Keys to Success

H

ospitals that are eyeing an integrated infusion management system can learn some valuable lessons from WellSpan Health’s experience with the technology. Sharon Muller, RN, MSN, WellSpan’s coordinator of nursing informatics, said the following strategies helped ensure a successful rollout: Begin with the right components—but not in isolation. Hospitals need to have bar-coding, smart pumps and an electronic health record system in place, and also have the ability to do order entry electronically, to get started on this type of initiative. “Each of those technologies [by itself] provides huge safety benefits,” Ms. Muller said. “But as you start to layer them onto each other, you see more and more increases in safety and efficiency.”

Ms. Muller described WellSpan’s decision to implement an integrated infusion management system as a “paradigm shift,” wherein many preconceived notions about pharmacy technology had to be discarded. One in particular: “We realized that a medical device can no longer be viewed as an isolated entity,” she said. “Its value increases dramatically when it is a component of the aggregate process. It has to be evaluated based on the data it can provide [to] clinicians.”

Be ready to work in teams. At WellSpan, Ms. Muller stressed, implementing the new integrated automated infusion management system was very complex, requiring partnerships among nurses, pharmacy, clinical and technical applications, bio-med, network and server support. “All of us had to learn to work and speak in ways we weren’t used to,” she said. “It was a huge learning curve.”

Also, “there has to be transparency, commitment and communication” among all team members.

Start with high-need areas. At the beginning of a pilot implementation in 2009, WellSpan focused on “high-data volume, high-acuity areas,” Ms. Muller said, such as the ICU, the emergency department and the postanesthesia care unit. In those areas, WellSpan connected monitors, ventilators and anesthesia machines.

Be demanding of your devices. Before implementation, WellSpan evaluated infusion pumps three times, “not feeling at first that the pumps were at the level they needed to be for safety and integration,” Ms. Muller said. “But in 2009, we felt they were ready.”

—L.P.

and Ho ospira’s Symbiq infusion devvices and MedNet safety ssoftware,” Mr. Gerhart wrote in an email.

During the webinar, itt was noted that these com mponents “provide bidirection nal, wireless communication bettween the smart pump and the eleectronic medical record, resulting in a closed-loop, integrated infusion manaagement system.”

Bar-code scan nning is another important cog cog—particularly partic in conjunction with the EHR, according to Ms. Muller.

When a bar code is scanned, that action sends electronically captured information about the infused medication to the pump, and the pump sends information to the EHR. “Real-time volume titration data are streamed from the pump into the EHR for the clinician to see,” she explained, “allowing real-time analysis and documentation of clinical data.”

By sending data to the pump automatically, Ms. Muller added, “you avoid manual programming errors where a nurse taps the wrong key, so the safety benefit is huge. The real-time streaming data give you a situational awareness that allows you to make clinical decisions based on accurate, actionable information.”

Dashboard Guides Clinicians The software within the infusion management system at WellSpan provides a “dashboard” view of infusion-related information to both pharmacy and nursing. This is done via a 50-inch monitor in the pharmacy’s IV anteroom area, where the software displays information on patient demographics, location, current medication order, current infusion rate, workflow sequence status and the time remaining before the infusion is complete. The data are displayed in columnar views that can be sorted according to what each user wants to prioritize.

In the pharmacy, technicians rather than pharmacists monitor the dashboard to determine what particular continuous infusions need to be prepared and delivered to the patient care area. “The pharmacy technicians have the insight into the process and they manage it independently rather than having pharmacists and nurses tied to that process,” Mr. Gerhart said. This approach is in stark contrast, he added, to the earlier system in place at WellSpan, where IV technicians were at the mercy of the IV printer that “spewed labels on an ongoing basis with little to no insight from the technician as to which orders took priority.”

Infusion stability is taken into account by the system as well. Certain standardsize infusion bags are tagged with a

•

see INTEGRATION, page 30

Technology 29

Pharmacy Practice News • February 2013

Compliance

Medication Reconciliation in a Snap P

atients who show up at the hospital with handfuls of pills or lists of scrawled drug regimens pose an alltoo-common challenge to pharmacists tasked with performing medication reconciliation. Fortunately, one new product may make this headache a bit less painful.

The MedSnap ID system consists of an optical pill recognition app that is compatible with an IPhone 4s or iPhone 5. In a typical scenario, a patient or caregiver brings from home all the medications the patient believes he or she takes. A health care provider pours a representative sampling of pills onto the tray, then holds the phone level above them and hits the Snap button on the iPhone screen. In a few seconds the system identifies and displays the names and strength of each drug (including some widely used over-the-counter drugs). It alerts for possible drug–drug interactions, drug–diagnosis interactions and allergy risks based on the patient’s medical history, if that information is known. Drug monographs for each of the thousands of compounds in the system’s database can be called up.

According to MedSnap, more than 12,000 prescription pills and capsules are on the market.

The same tasks, done manually, can easily take 30 to 40 minutes, said Patrick Hymel, MD, an emergency medicine physician and the CEO and co-founder of MedSnap. “Identifying precisely what medications a patient is taking is a major safety issue and a challenge for pharmacists. We address the ‘brown bag’ problem of medication reconciliation: when patients are asked to bring in all their prescriptions, then show up at the pharmacy, hospital, or clinic with unmarked pill bottles or, literally, bags full of pills.”

One of Dr. Hymel’s goals is to make assessment of drug regimens a “new vital sign” that’s quick and easy to gauge.

“We think this is very fertile ground in terms of how pharmacists can contribute to better outcomes,” he said.

MedSnap ID, slated for market release in the first quarter of 2013, will cost $69.99 annually for the software per iPhone, and $29.99 for the rigid “Premium Tray,” or $19.99 for two portable “pocket-friendly” Lite surfaces.

Users supply the iPhones.

Beta Tester Gives Tool A High Score “This is a potentially valuable tool for medication reconciliation and should allow clinicians to more accurately capture the drugs a patient is really taking rather than relying on recall,”

said Michael D. Hogue, PharmD, FAPhA, FNAP, the chair of the Department of Pharmacy Practice and an associate professor at the McWhorter School of Pharmacy, Samford University, in Birmingham, Ala., one of the sites beta-testing MedSnap ID. “It’s an interesting device, a very innovative concept, and it’s very user-friendly and can accurately identify literally thousands of prescription medications.”

According to Dr. Hogue, several dozen pharmacy students have been

•

see MEDSNAP, page 30

Focus on Inhaled Anesthesia Podcast Series Podcast 3

How to Run an Efficient OR: Collaboration Between Anesthesia Providers and OR Staff Richard Pitera Jr., MD Anesthesiologist and Director of Perioperative Medicine St. Barnabas Medical Center Livingston, New Jersey Learning Objectives: • Discuss the patient- and hospital-related benefits of improved collaboration between anesthesia providers and other operating room (OR) staff.

• •

Identify perioperative management protocols that enhance efficiency and safe patient throughput in the OR. Discuss the fast-tracking protocol efficiency.

The Inhaled Anesthesia Podcast Series is supported by Baxter Healthcare Corporation.

Baxter is a registered trademark of Baxter International Inc.

Listen @ 743092C 12 /12

www.anesthesiologynews.com/podcast www.pharmacypracticenews.com/podcast

30 Technology

Pharmacy Practice News • February 2013

Automation

INTEGRATION continued from page 28

24-hour expiration date via the pharmacy information system. When these infusions are administered at infusion rates that would result in the infusion exceeding its stability, the time remaining calculation is based on this expiration time instead of the actual time remaining for the bag, Mr. Gerhart said.

“That takes the guesswork out of it for nursing,” he added. “The delivery

of a new bag to the [nursing area] is their indicator that they have to hang a new bag immediately.” Before the rollout, “we were forced to rely on nurses recognizing that a bag has hung for over 24 hours. Now, in contrast, we are minimizing the possibility of patients receiving suboptimal infusions that have outlived their stability.”

The older system was further hampered by another scheduling flaw: It resulted in the production of continuous infusions with standard, scheduled

A Particular Boon to Nurses

T

here are several technology components in the new integrated infusion management system at WellsSpan Health. But the view of infusion status that can be gleaned from the infusion pumps may be one of the most welcome features to nurses, according to Sharon Muller, RN, MSN, the hospital system’s coordinator of nursing informatics.

Data displayed on the pump’s monitor show the order name, dose and rate, weight of the patient, volume to be infused, time to start infusion, and time remaining in “a continuous volume countdown,” Ms. Muller explained. In a typical use situation, the nurse verifies that all the information on the display is correct and that starts the pump’s two-way communication with the electronic health record.

“Once the data start flowing,” Ms. Muller said, “the clinicians can see the documentation in a number of different views, including an interactive view of all devices associated with the patient, including the pumps, monitors and ventilators.”

The pump displays a real-time view of “exactly what is infusing in a patient,” she further explained, as well as the status of an infusion and when it is going to be complete. “The nurse can quickly see what she needs to bring into the patient’s room, so if she is out at the desk, she can still see when she has to bring the next medication into the room.” The system also gives nurses a view of all the patients and their associated infusions on a unit level.

With the system and its various views, “the nurse is no longer the integrator of data,” Ms. Muller said. “She or he can let the pump send the data and she or he can then spend more time evaluating, synthesizing, looking at the data and focusing on it to see the full clinical picture.”

In addition to documenting what has been done in real time, with every titration the system displays for nurses a set of vital signs, and it graphs the data.

All these views and data points “simplify and streamline the IV medication process” for nursing, Ms. Muller said. As a result, the number of steps in the medication process “went from up to 42 down to seven when you program a weight-based medication. And, when you document what’s been done, the number of steps drop from 14 down to two.”

Additionally, in 97% of infusions, all the drugs being programmed are in the drug library on the pump, making optimal use of the pump’s safety software.

Chip Gerhart, RPh, the medication safety officer at WellSpan York Hospital, pointed to another major benefit of the workflow management system. Because it integrates with nursing views for each infusion, he explained, nurses gain insight into the production of each infusion, “eliminating the need for direct contact with pharmacy personnel altogether and minimizing disruptions to normal workflows for both groups.” This benefit alone has enhanced patient safety, Mr. Gerhart added, “because the safety literature demonstrates that distractions lead to errors.”

—L.P.

MEDSNAP continued from page 29

voluntarily using the device during their clinical rounds and documenting its accuracy. The intent is to capture as many different medications in as many different lighting conditions as possible, ensure the system’s precision, round out the drug database and identify remaining weak spots and fix them.

The company plans to follow MedSnap ID with MedSnap PT for patients.

In addition to drug and dose identification, it also will include medication management reminders and schedules, as well as alerts when patients are at risk for taking the wrong drug or dose. The device is intended for people who live independently, although it can be operated by caregivers of patients who are incapable of manipulating the device

administration rates hours in advance of need. When orders were changed or discontinued in the interim between production and administration, these infusions had to be picked up and returned to the pharmacy, taking up a technician’s time and creating the potential for waste or possible errors if they were redistributed. In the new system, by not doing batch fills in advance of need, WellSpan is seeing “significant reductions in the volume of products coming back for credit,” Mr. Gerhart said. “We are not only realizing the cost savings for the drugs themselves, but also the savings in time for our technicians from not having to credit and destroy these products.” Moreover, returns and credits now automatically recalculate the time remaining in the dashboard, and the technicians also can see when an order has been modified or changed in any way, he noted.

Mr. Gerhart added that the flexibility of the workflow management component allows the pharmacy to assign different workflow sequences to each product should the pharmacy need additional pharmacist checks for high-risk medications. “Accountability and product tracking are further enhanced because the system records date, time and user information on each step,” he said.

Benefits of Integrated Infusion At WellSpan In Pharmacy • Minimizes pharmacy technician time wasted preparing batch lists of infusions hours in advance of need that are later discontinued prior to administration • Decreases technician time spent returning and crediting doses of unused medications • Decreases medication waste • Decreases overall drug expense by reducing medication waste associated with batch production when products with limited stability are prepared and then discontinued prior to administration

In Nursing • A 27% reduction in nursing time required to start and document each new infusion • A 50% reduction in nursing time required to titrate an existing infusion and document it • A time reduction of 13 to 16 seconds per titration, which equaled 1,300 nursing hours saved per year

Measures of Success From July 2011 to January 2012, WellSpan documented 90 near-miss medication errors involved in the administration of IV infusions that were caught by the updated system, Ms. Muller noted. “We estimated cost savings of $77,000 for that time period and $132,000 annually for just the 10-bed ICU,” she said. “That calculation was based on 10% of the 90 errors reaching the patient and causing harm without the system in place.”

In addition, WellSpan calculated a 27% reduction in the time it took nurses to document the start of a new infusion and a 50% reduction in the time required to titrate an infusion and document that process. This equated to an estimated total of 1,300 nursing hours per year.

But numbers tell only part of the story.

The nurses “have loved this [new system], especially in those critical situations where you don’t have orders and you are trying to write down vital signs and infusion information quickly, while focusing on taking care of the patient,” Ms. Muller said. “After the emergency is over and the patient is taken care of, the nurse can go back and pull all the data from the pump into the EHR. No more writing clinical data down on scraps of paper or on scrub pant legs.” (For more nursing benefits, see sidebar, “A Particular Boon to Nurses.”)

Mr. Gerhart added that the pharmacy technicians now have “a great amount of control over their workload, an opportunity they greatly appreciate.”

—Liz Parks

themselves, such as those in assisted-living facilities.

A free version of the app for caregivers (MedSnap CG), and one that will provide secure data to electronic medical record systems (MedSnap Connect) also are in development.

Dr. Hogue also envisions the MedSnap systems as potentially valuable tools for ensuring medication adherence during tran-

sitions of care. For example, after a patient is discharged from the hospital, a community pharmacist could snap a photo of all the medications prescribed for home use. “If that patient prepares to take a medication at home and snaps an image of the wrong drug with the MedSnap,” said Dr. Hogue, “the system can warn them that it’s not what they’re supposed to take and prompt them to call their pharmacist or physician to get the correct information.”

—Steve Frandzel

This is the biologic medicine That the patient counts on That the nurse trusts That the pharmacist has confidence in That the doctor relies on Because it was manufactured knowing the patient’s treatment depends on it.

Building confidence in the quality and supply of biologic medicines starts with a deeper understanding of how these medicines are made.

After all, there’s so much at stake.

That’s why manufacturing matters.

Learn more at

buildingbiologics.com

An educational initiative from ©2012 Amgen Inc. All rights reserved. 71325-R1-V1

Grifols ! ,EADING -ANUFACTURER OF 0LASMA 0ROTEIN 4HERAPIES Vertical integration with geographic diversity helps ensure continuous production of therapies s 4HE LARGEST NETWORK OF SOURCE PLASMA DONOR CENTERS IN THE INDUSTRY 1 PROVIDES 'RIFOLS WITH A DEPENDABLE SUPPLY OF THE PLASMA NEEDED TO PRODUCE OUR THERAPIES s 4WO 'RIFOLS OWNED STATE OF THE ART PLASMA TESTING FACILITIES s 4HE LARGEST PLASMA PROTEIN FRACTIONATION CAPACITY IN THE WORLD 1 s 4HREE GLOBAL PLASMA PROTEIN MANUFACTURING FACILITIES

'RIFOLS &RACTIONATION &ACILITY ,OS !NGELES #!

3TATE OF THE !RT 0RODUCTION 0ROCESSES

A Broad Range of Plasma Protein Therapies Albumin (UMAN MARKETED AS AlbuteinÂŽ 5% AlbuteinÂŽ 25% PlasbuminÂŽ-5 AND PlasbuminÂŽ-25 Alpha1- Proteinase Inhibitor (UMAN MARKETED AS ProlastinÂŽ-C Antihemophilic Factor/von Willebrand Factor Complex (UMAN MARKETED AS AlphanateÂŽ Antithrombin III (UMAN MARKETED AS Thrombate IIIÂŽ Coagulation Factor IX (UMAN MARKETED AS AlphaNineÂŽ SD Factor IX Complex MARKETED AS ProďŹ lnineÂŽ SD Immune Globulin Intravenous (UMAN OR IVIG Immune Globulin Injection (UMAN Hyperimmune Globulin Therapy Products MARKETED AS Hypermunesâ&#x201E;˘: Rabies Immune Globulin (UMAN MARKETED AS HyperRABÂŽ S/D Tetanus Immune Globulin (UMAN MARKETED AS HyperTETÂŽ S/D Rho(D) Immune Globulin (UMAN MARKETED AS HyperRHOÂŽ S/D Hepatitis B Immune Globulin (UMAN MARKETED AS HyperHEP BÂŽ S/D

'RIFOLS ALSO PROVIDES OPERATIONAL SOLUTIONS FOR COMPOUNDING AREAS IN PHARMACY AND DIAGNOSTIC INSTRUMENTATION

REAGENTS SOFTWARE AND RELATED PRODUCTS FOR THE CLINICAL LABORATORY

Learn more about how Grifols can meet your hospitalâ&#x20AC;&#x2122;s needs at www.grifols.com -ARKETING 2ESEARCH "UREAU DATA *UNE

ÂĽ 'RIFOLS "IOLOGICALS )NC !LL RIGHTS RESERVED 0RINTED IN 53! *UNE #/

PRINTER-FRIENDLY VERSION AVAILABLE AT PHARMACYPRACTICENEWS.COM

The Use of Opioids in Chronic Pain: Complexity and Practice JOHN F. PEPPIN, DO, FACP Associate Medical Director Hospice of the Bluegrass Palliative Care Center of the Bluegrass Director Center for Bioethics, Pain Management and Medicine Lexington, Kentucky

C

hronic or recurrent pain occurring on

a regular basis

affects more than 25% of the US population.1 This issue became recognized nationally more than 4 decades ago and both clinicians and patients began to advocate for improved pain care.

At that time, many seasoned pain physicians considered opioid therapy to be not only safe but also a mainstay of chronic pain treatment. However, more recently, those same physicians have grown sanguine about the use of opioids, as the downside of the class has become more apparent.

There has been a lack of progress in the treatment of chronic pain and a paucity of physicians who specialize in the field of pain medicine.2 Furthermore, the environment for the treatment of pain has become antagonistic, as state and federal agencies, committees, legislators,

I N D E P E N D E N T LY D E V E L O P E D B Y M C M A H O N P U B L I S H I N G

and regulators focus on physician prescribing of scheduled medications in an apparent effort to reduce abuse, misuse, addiction, and overdose deaths. There is no one answer to the problem of scheduled medication or illicit drug abuse, misuse, addiction, or overdose deaths, just like there is no one answer to the treatment of chronic pain. Opioids have a role in the treatment of chronic pain, as part of a multidisciplinary multimodal program, and can be effective in the appropriately selected patient, but they are not a panacea. Although the treatment of these patients is fraught with complexity, it is how

P H A R M AC Y P R AC T I C E N E WS â&#x20AC;˘ F E B R UA RY 2 0 1 3

1

that selection should occur that this review attempts to elucidate.

When approaching a chronic pain patient it is critical to keep in mind that the effective evaluation, diagnosis, and treatment are complex and require a multimodal and open philosophy. This multimodal approach is supported by research that demonstrates the lack of efficacy of many of the unimodal interventions, both pharmacologic and nonpharmacologic.3 Weisman’s warning about minimizing the complexities of the treatment of chronic pain came a decade ago; unfortunately, his caution has not been heeded.4 From the perspective of the busy clinician, the treatment of chronic pain can be viewed as overwhelming.

Furthermore, given the scarcity of trained pain practitioners and the burgeoning number of patients with chronic pain, a new approach is needed that values the complex nature of chronic pain. There is no simple treatment approach to these patients; the complex nature of chronic pain necessitates that time and effort be applied to its management.

Opioids can be a potent tool in the treatment of chronic pain but should never be the default standard.

Some patients respond well to opioid therapy, others

Table 1. Domains That Affect Chronic Pain Treatment Medical comorbidities 5-21 Other concomitant symptoms (symptom clusters) Psychiatric and psychological comorbidities Scheduled medication diversion and abuse risk Number of chronic pain problems Number of past surgeries Tobacco use Head trauma history Body mass index Goal setting Sleep disorders Educational level and employment status Current pharmacotherapy regimen Level of social support Physical conditioning Current pain intensity

2

I N D E P E N D E N T LY D E V E L O P E D B Y M C M A H O N P U B L I S H I N G

do not, and for some the risk outweighs any potential benefit. A comprehensive evaluation can aid in determining the most appropriate therapeutic approach for an individual patient. Although a focused approach to evaluation and treatment selection might be useful for certain diseases, in chronic pain only a comprehensive and full evaluation that also assesses potentially confounding factors is the appropriate course. Comorbidities and confounders will hinder success with any treatment approach. The categories listed in Table 1 may affect chronic pain and should be assessed with any evaluation of a patient with chronic pain.5-21

Evaluation All patients entering a chronic pain treatment program should be given and sign a pain management agreement (it is best to describe and label these as “agreements” rather than the legally loaded term contract).22,23 The pain management agreement is an essential part of the initial evaluation, and it should always be discussed, in detail, directly with the patient by the practitioner. This agreement can specify what the practitioner will do for the patient and what is required of the patient in return. The pain management agreement should never be a list of “thou shalt not’s,” but rather a template for how treatment will proceed and what is required from both the patient and pain practitioner. The agreement should never be used as punishment, or as a tool to discharge patients.

As with urine drug monitoring (UDM), the agreement can be used as an opportunity for discussion with the patient concerning violations and the patient’s progress. Furthermore, the agreement should be given to all patients, regardless of the specific treatment regimen.

The evaluation of a patient with chronic pain starts with a full and complete history and physical examination (Table 2). A “focused examination” should never be the approach in the treatment of these patients.21 For example, a chronic pain patient has 3.2 pain problems on average when he or she presents for the major pain complaint. Interestingly, data shows that low back pain will reduce pain thresholds in other areas of the body.9 If a focused evaluation is conducted, these pain generators and other issues will be missed, and treatment will more likely be unsuccessful.

This evaluation should set the stage for everything that follows. The history should establish the most consistent diagnoses and the physical examination helps to support those diagnoses. The initial evaluation will help define clear goals. Furthermore, it may find evidence of overt and concealed comorbidities that need to be addressed. Although this first evaluation is timeintensive, the time spent may well be more than made up for in future visits by a thorough knowledge of the patient’s pain problems and medical condition. Again, management of chronic pain is a complex medical paradigm. Although it should be obvious, full and complete documentation is a critical part of every patient

visit. Documentation is one of the major weaknesses of prescribers who have problems with regulatory boards or federal agencies.24 As part of the initial evaluation, obtaining a record of previous treatments and treating physicians also is critical. These records can establish patterns of concern and suggest treatments that have been successful or those that should be avoided.

Additionally, they may suggest potential problems in a given patient’s care, such as a high risk for abuse of scheduled medications or addiction.

As with any medical intervention, informed consent is the foundation by which to engage in any treatment.21,23 Patients need to be apprised of the potential risks and benefits of any treatment and this is no less true with scheduled and controlled medications. The potential for side effects (eg, constipation or nausea, the potential risk for addiction, potential drug interactions, endocrinopathies, and sleep apnea), should be clarified for the patient. Appropriate documentation of this process should be present in the record and chart as well.

Patients with chronic pain frequently have multiple comorbidities.21,23 For example, sleep apnea (central or obstructive), frequently under diagnosed, may be more common, especially in patients on chronic opioid therapy.25 The pain patient being treated with opioids who also has sleep apnea may be at risk for death.15 Additionally, insomnia and sleep disturbance, and endocrinopathies, are common in chronic pain.26 Frequently, these patients have underlying psychiatric comorbidities (eg, anxiety and depression) that often go untreated.22,23,27 Numerous screening tools to evaluate for underlying psychiatric problems are available and should be used. The Zung Self Rating Depression and Anxiety scales and the Beck Depression Inventory are such screening tools.28-30 These tools can be given simply and easily to patients by office staff and can identify those in need of treatment or those in need of a more thorough psychological evaluation. Furthermore, a number of screening tools have appeared in the literature within the past few years to aid in risk stratification for potential opioid abuse.22,23 Passik and his colleagues have conducted a thorough comparison of available tools and recommend the Opioid Risk Tool, when brevity is needed, and the Screener and Opioid Assessment for Patients with Pain, a good choice among the longer measures.31 It should be noted that these screening tools are not substitutes for a psychological assessment by a trained pain psychologist.

Regardless of what treatment a chronic pain patient is given, it is important to screen for and treat the disease of addiction.

Knowing which patient to start on opioids is not a simple question; neither does the answer to this question lend itself to protocols or a “set of rules.” It depends on a gestalt based on previous treatments, patient risk, psychological profile, and other factors. Once the gestalt identifies a patient who might benefit from opioids, treatment can be started. However, there should

Table 2. Overview of the Approach To the Chronic Pain Patient Complete evaluation, history, and physical Psychiatric evaluation and screening (eg, Beck, Zung, etc) Risk evaluation for opioids (eg, ORT or SOAPP) Pain agreements Prescription monitoring programs Understand federal and state laws and regulations pertaining to pain clinics and use of opioids If opioids are used, no weekend or after-hours prescriptions or call-ins Use of methadone: Make sure you understand its complexities Review of the complexity domains (Table 1) ORT, Opioid Risk Tool; SOAPP, Screener and Opioid Assessment for Patients with Pain

always be an exit strategy, which should be discussed with the patient up front.22 Additionally, if your evaluation and diagnoses suggest that opioids might be one aspect of a patient’s treatment plan, long-acting rather than short-acting opioids should be considered.32 Furthermore, the lowest dose that provides the best pain relief, improved function, and quality of life should be used. In addition, the patient should be required to use only one pharmacy for all scheduled medications.33 Most patients in this population may benefit from adjuvant medications, such as antiepileptics, tricyclic antidepressants, serotonin norepinephrine reuptake inhibitors, α-agonists, and others.22,23 As mentioned previously, old medical records can help with this data collection. They also can elucidate if the patient was on a therapeutic dose of a previously tried medication, which might suggest a retrial with titration to higher and more effective doses (eg, venlafaxine at 75 mg per day). The addition of adjuvants can provide a synergistic benefit. One pilot study found the use of an adjuvant (gabapentin) with morphine created a synergistic effect, reducing the dose of both agents.32 Furthermore, a recent Cochrane collaboration review has shown that combination therapy has “superior efficacy” compared with single-drug therapy.34 Additionally, pain psychology and behavioral therapy, physical therapy, manipulative therapies, and interventional pain medicine all should be considered and applied when appropriate. Again, this is part of a multidisciplinary, multimodal approach to the treatment of chronic pain.

I N D E P E N D E N T LY D E V E L O P E D B Y M C M A H O N P U B L I S H I N G

3

Reassess, reassess, reassess.

open up dialogue. A UDM that is positive for cocaine is a potential opening to discuss the patient’s need for treatment. Although clear research data on UDM efficacy in reducing “abuse, misuse, addiction, and overdose deaths”a does not exist, many professional organizations, regulatory agencies, and others recommend the use of UDM.23 Have a clear plan on how to deal with inconsistent UDM results, results that you don’t understand, and how to generally incorporate UDM into your practice. For more information, see Peppin et al.38

Know your limitations.

Reassessment

Table 3. Staying Out of Trouble Follow the complete evaluation of a chronic pain patient (Table 2).

Discontinue treatment that fails.

Document well and document everything.

Refer for addiction counseling, do not continue opioid treatment in active addicts.

Refer to pain specialist when needed.

Patient and pain practitioner goals for any treatment are critical and these should be established in documentation from the initial evaluation. What does the patient want to achieve? All patients with chronic pain want “less pain”; however, improved function and quality of life must be discussed and included when setting goals. Each goal should be listed in the original evaluation and readdressed as the treatment regimen is instituted and the patient is followed. Unrealistic expectations may cause treatment failure and must be addressed. Furthermore, a rigorous adherence to reduction in pain numbers should be avoided. Function and quality of life are much more important goals and markers of success than a single pain number, again reflecting the complexity of this chronic syndrome.

One possible, and easy, measurement of patient function is the 6-Minute Walk.35 Office staff can administer this easily.

Setting clear rules and expectations at the initial visit can be done both verbally as well as in the pain agreement. It is critical that we keep boundaries and clear consequences should those boundaries be crossed and violated. However, boundaries should be occasions for discussion with the patient, and not a tool to discharge or punish them. A practitioner may refuse to prescribe scheduled medications to a patient who has violated boundaries but instead may offer addiction treatment, treatment of potential withdrawals, antidepressants, adjuvants, and so on.

UDM should be a consistent part of any chronic pain program in which chronic opioid therapy is being considered. Although UDM can be a very useful test to help identify abuse, misuse, or addiction, its use both by pain specialists and primary care physicians is surprisingly low (8%-30%).36,37 There is a risk for misinterpreting UDM results and potentially harming a patient.

This is one reason why practitioners should have a good understanding of the UDM report and a good relationship with whatever laboratory is being used. The UDM should never be used to penalize a patient, but rather to

4

I N D E P E N D E N T LY D E V E L O P E D B Y M C M A H O N P U B L I S H I N G

Although a full and thorough history and physical are critical to the initial evaluation of the patient with chronic pain, continued treatment requires constant reassessment (Table 3). Patients are not static in time, they are fluid and things can change quickly. New pain states, the discovery of abuse or addiction not found on the initial evaluation, and new comorbidities all can affect the success of treatment. The 4 A’s can help formalize this reassessment when it comes to opioids.39 The 4 A’s are: • Analgesia (pain relief) • Activities of daily living (ADLs; functional outcomes) • Adverse effects (side effects) • Aberrant drug-related behaviors (appropriate use and adherence versus misuse or addiction-related outcomes).

However, the assessment for potentially developing complications of therapy, sleep issues, psychiatric issues, and so on, also should occur. This cannot be emphasized enough and is a critical, often overlooked, piece in the appropriate treatment of chronic pain patients on chronic opioid therapy. Patients should be seen more frequently when medications are changed or increased, but once a patient is stable, the time between visits can be longer. Most regulatory boards state that physicians and providers who are prescribing scheduled medications must see their patients “regularly,” although rarely is this defined.40 The Drug Enforcement Administration (DEA) allows physicians to write class II prescriptions with a “do not dispense” label, which specifies when prescriptions can be filled.

This allows physicians to write multiple prescriptions at once but prevents early filling before the dates specified on the prescription. Physicians must fully understand federal and regulatory laws and guidelines before writing a prescription for any scheduled medication.41 Patients with exacerbations of chronic pain should not go to the emergency department (ED). The pain agreement should specify that the patient will be seen in the clinic as soon as possible to treat his or her exacerbation; however, the ED is “off limits” for chronic pain. Clearly explain to patients that any other issue (ie, shortness of breath, chest pain, etc) still indicates they should indeed go to the ED. The 4 A’s should be assessed at every visit, especially in patients on opioids.22,39

Pill counts are another way to check on patient compliance with scheduled medications. It should always be done in front of the patient with a witness present. The pills should be counted twice and the patient, pain practitioner, or nurse, and the witness should sign a form indicating how many pills were present. This documentation should be in the patient’s permanent record. A DEA registrant cannot take possession of any patient’s scheduled medications; this is a federal felony.42 However, if a medication trial has failed and there are leftover medications, having the patient dispose of them appropriately in the pain facility is acceptable.

It is still not clear if prescription monitoring programs (PMPs) have a significant effect on diversion, but they do represent a standard of care in states where they exist and should be used. An example of PMP is KASPAR (Kentucky All Schedule Prescription Electronic Reporting).43 How often to order a PMP report on a given patient is not clear. Again, it is critical for physicians to know their state’s regulations and laws.

Recent legislation in Kentucky requires that PMP reports be obtained on all patients on opioid therapy.44 When treating a number of chronic pain patients with opioids, pain practitioners must get to know local law enforcement and work with them. Although the current regulatory and legislative environment is antagonistic to good pain care, there are members of law enforcement who understand the importance of treating chronic pain. For each prescription, the individual script number, patient name, and date should be documented. Each scheduled prescription should include the generic name of medication, doses in both alpha and numeric form, the strength, and the patient’s address.46 Anyone who comes to the office to pick up a prescription, especially for scheduled medications, should be required to show a photo identification. This should be spelled out in the pain agreement.

Facilty personnel should document the person picking up the prescription, and photocopy the identification. Additionally, the pain agreement should clearly state that no prescriptions will be provided after hours, on weekends, or vacations. Patients should be responsible with their medications, and waiting until 5 PM on a Friday to request a refill is not responsible.

When treatment fails, it should be discontinued; although obvious, clinicians frequently get themselves into legal and regulatory trouble for this very reason.46 If a patient is placed on a scheduled medication and there is no improvement in his or her pain levels, quality of life, or function, the treatment should be modified or changed.

The use of methadone for chronic pain should be approached very cautiously. This medication carries with it great complexity and uncertainty. It requires experience and understanding of its pharmacology and potential drug–drug interactions. Comorbidities such as sleep apnea or congenital prolonged QT interval syndrome must be identified. Furthermore,

the as-needed use of methadone must be strictly avoided. 47 Patients should be counseled in detail about this medication. They should call the prescribing physician before starting any new medications, or the consulting physician should call the prescribing physician to discuss the potential for interactions. Prescribers who do not feel comfortable with this medication should get training, or leave it for an experienced expert.

Conclusion The treatment of chronic pain is complex and there is no simple or easy approach to treat these patients.

The use of opioids in the treatment of chronic pain is complicated; there is no easy approach to their use.

Furthermore, they are not a panacea or magic answer to patients’ pain. The use of opioids requires knowledge of pharmacology, comorbidities, medication side effects, appropriate outcomes, addiction, and abuse, as well as psychiatric disorders. All chronic pain patients should receive a full and thorough initial history and physical examination, without which treatment of these patients may well fail. Additionally, these patients should be reassessed with every visit. Practitioners who are interested in expanding into the treatment of pain patients can obtain further training and even board certification through professional organizations and educational programs. Subscribing to a pain journal and reading current literature also can be of help. However, the complexities of chronic pain cannot be minimalized, and treating these patients must take these complexities into account.

Dr. reported that he has consulted for AIT Laboratories, Ameritox, Depomed, INSYS Therapeutics, and Salix Pharmaceuticals. a

The terms abuse, misuse, addiction, and overdose deaths, have been goal terms in FDA discussion (although they are poorly defined). (Rappaport BA. Food and Drug Administration Elements of the proposed REMS for long-acting and extended-release opioid drug products. Slide presentation, June 22, 2010, Joint meeting of the Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committees).

References 1.

http://www.painmed.org/patientcenter/facts_on_pain. aspx#incidence.

2.

Coughlin AM, Badura AS, Fleischer TD, Guck TP. Multidisciplinary treatment of chronic pain patients: its efficacy in changing patient locus of control. Arch Phys Med Rehabil.

2000;81:739-740.

3.

Sarzi-Puttini P, Atzeni F, et al. Multidisciplinary approach to fibromyalgia: what is the teaching? Best Pract Res Clin Rheumatol. 2011;25:311-319.

4.

Weissman DE. Progress in pain management: is the emperor dressed? J Palliat Med. 2004;7(3):391-392.

5.

Can Dijk GM, Veenhof C, Schellevis F, et al. Comorbidity, limitations in activities and pain in patients with osteoarthritis of the hip or knee. BMC Musculoskelet Disord. 2008;9:95. doi:10.1186/1471-2474-9-95.

6.

Miaskowski C, Dodd M, Lee K. Symptom clusters: the new frontier in symptom management research. J Natl Cancer Inst Monogr. 2004;32:17-21.

I N D E P E N D E N T LY D E V E L O P E D B Y M C M A H O N P U B L I S H I N G

5

7.

8.

Jones EA, McBeth J, Nicholl B, et al. What characterizes persons who do not report musculoskeletal pain? Results from a 4-year population-based longitudinal study (The Epifund Study). J Rheumatol. 2009 Apr 15. [Epub ahead of print] Passik SD, Squire P. Current risk assessment and management paradigms: snapshots in the life of the pain specialist. Pain Med. 2009;10(suppl):S101-S114.

9.

Clauw DJ, Williams D, Lauerman W, et al. Pain sensitivity as a correlate of clinical status in individuals with chronic low back pain. Spine. 1999;24:2035-2041.

10.

Mallen CD, Peat G, Thomas E, Dunn KM, Croft PR. Prognostic factors for musculoskeletal pain in primary care: a systematic review. Br J Gen Pract. 2007;57:655-661.

11.

Schulte E, Hermann K, Berghöfer A, et al. Referral practices in patients suffering from non-malignant chronic pain.

Eur J Pain. 2010;14(3):308e1-308e10.

12.

Sawatzky R, Liu-Ambrose T, Miller WC, Marra CA. Physical activity as a mediator of the impact of chronic conditions on quality of life in older adults. Health Qual Life Outcomes.

2007;19:68. [http://www.ncbi.nlm.nih.gov/pmc/articles/ PMC2246116/pdf/1477-7525-5-68.pdf]

13.

Dobscha SK, Clark ME, et al. Systematic review of the literature on pain inpatients with polytrauma including traumatic brain injury. Pain Med. 2009;10:1200-1217.

14.

Heuch I, Heuch I, Hagen K, Zwart JA. Body mass index as a risk factor for developing chronic low back pain: a follow-up in the Nord-Trøndelag Health Study. Spine. 2012 Jun 20.

[Epub ahead of print]

15.

Tang NK, Goodchild CE, Sanborn AN, Howard J, Salkovskis PM. Deciphering the temporal link between pain and sleep in a heterogeneous chronic pain patient sample: a multilevel daily process study. Sleep. 2012;35:675-687A.

16.

Okifuji A, Hare BD. Do sleep disorders contribute to pain sensitivity? Curr Rheumatol Rep. 2011;13:528-534.

17.

Fisher K, Hardie RJ. Goal attainment scaling in evaluating a multidisciplinary pain management programme. Clin Rehabil.

2002;16:871-877.

18.

Roth RS, Punch MR, Bachman JE. Educational achievement and pain disability among women with chronic pelvic pain.

J Psychosom Res. 2001;51:563-569.

19.

Fishbain DA. Polypharmacy treatment approaches to the psychiatric and somatic comorbidities found in patients with chronic pain. Am J Phys Med Rehabil. 2005;84(suppl): S56-S63.

29.

30. Zung WW, Richards CB, Short MJ. Self-rating depression scale in an outpatient clinic: further validation of the SDS. Arch Gen Psychiatry. 1965;13:508-515.

31.

Passik SD, Kirsh KL. Chemical coping: the clinical middle ground. In: Smith HS & Passik SD, eds. Pain and Chemical Dependency. New York, NY: Oxford University Press; 2008:299-302.

32.

Fine P, Mahajan G, McPherson ML. Long-acting opioids and short-acting opioids: appropriate use in chronic pain management. Pain Med. 2009;10:S79-S88.

33.

Strickland JM, Huskey A, Brushwood DB. Pharmacistphysician collaboration in pain management practice.

J Opioid Manag. 2007;3:295-301.

34. Chaparro LE, Wiffer PJ, Moore RA & Gilron I. Combination pharmacotherapy for the treatment of neuropathic pain in adults. Cochrane Databases Syst Rev. Cochrane Database Syst Rev. 2012;11:CD008943.

35.

Elazzazi A, Chapman N, Murphy, White R. Measurement of distance walked and physiologic responses to a 6-minute walk test on level ground and on a treadmill: a comparative study.

J Geriatr Phys Ther. 2012;35:2-7.

36.

Bhamb B, Brown D, Hariharan J, et al. Survey of select practice behaviors by primary care physicians on the use of opioids for chronic pain. Curr Med Res Opin. 2006;22(9):1859-1865.

37.

Boulanger A, Clark AJ, Squire P, Cui E, Horbay GL. Chronic pain in Canada: have we improved our management of chronic noncancer pain? Pain Res Manag. 2007;12:39-47.

38. Peppin JF, Passik S, et al. Recommendations for urine drug monitoring as a component of opioid therapy in the treatment of chronic pain. Pain Med. 2011:13;886-896.

39.

Peppin JF. Klin G, Burke J, Kirsh KL. A partial review of the appropriate use of opioid analgesics in the treatment of chronic pain: toward a model of good practice and rational pharmacotherapy. Crit Rev Phys Rehabil Med. 2009;21:25-65.

22.

Gourlay DL, Heit HA, Almahrezi A. Universal precautions in pain medicine: a rational approach to the treatment of chronic pain. Pain Med. 2005;6:107-112.

23.

Gourlay D, Heit H. Universal precautions: a matter of mutual trust and responsibility. Pain Med. 2006;7:210-211.

24. Bovbjerg RR et al. State discipline of physicians: assessing state medical boards through case studies. Washington, DC: U.S. Department of Health and Human Services; February, 2006.

25.

Webster LR, Choi Y, Desai H, et al. Sleep-disordered breathing and chronic opioid therapy. Pain Med. 2008; 9(4):425-432.

26.

Merza Z. Chronic use of opioids and the endocrine system.

Horm Metab Res. 2010;42:621-626.

27.

Bair MJ, Wu J, Damush TM, Sutherland JM, Kroenke K. Association of depression and anxiety alone and in combination with chronic musculoskeletal pain in primary care patients.

Psychosom Med. 2008;70:890-897.

28.

http://www.ibogaine.desk.nl/graphics/3639b1c_23.pdf.

6

I N D E P E N D E N T LY D E V E L O P E D B Y M C M A H O N P U B L I S H I N G

Passik SD, Weinreb HJ. Managing chronic nonmalignant pain: overcoming obstacles to the use of opioids. Adv Ther.

2000;17:70-83.

40. Gilson AM, Maurer MA, Joranson DE. State medical board members’ beliefs about pain, addiction and diversion and abuse: a changing regulatory environment. J Pain.

2007;8:682-691.

41.

Drug Enforcement Administration. Practitioner’s Manual: An Informational Outline of the Controlled Substances Act. 2006. http://www.deadiversion.usdoj.gov/pubs/manuals/ pract/index.html. Accessed Oct. 13, 2012.; Code of Federal Regulations, Title 21, Food and Drugs; Section 1306.05, Manner of issuance of prescription.2010. http://www.gpo.gov/ fdsys/pkg/CFR-2010-title21-vol9/pdf/CFR-2010-title21-vol9chapII.pdf. Accessed October 13, 2012.

42.

United States Code, Title 21, Sect. 841(b)(C), Penalties. 2010. http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/ USCODE-2010-title21-chap13.pdf. Accessed October 13, 2012; Under States Code, Title 21, Sect. 844, Simple Possession.

2010. http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/ pdf/USCODE-2010-title21-chap13.pdf. Accessed Oct. 13, 2012.

20. Ellingson LD, Colbert LH, Cook DB. Physical activity is related to pain sensitivity in healthy women. Med Sci Sports Exerc.

2012;44:1401-1406.

21.

Zung WW. A rating instrument for anxiety disorders.

Psychosomatics. 1971;12:371-379.

43. KASPER: Kentucky All Schedule Prescription Electronic Reporting; http://chfs.ky.gov/os/oig/KASPER.htm. Accessed March 22, 2009.

44. http://boards.medscape.com/forums?128@474.7Xx4aSy8lhJ @.2a339438!comment=1.

45. Code of Federal Regulations, Title 21, Food and Drugs; Section 1306.05, Manner of issuance of prescription.2010. http://www. gpo.gov/fdsys/pkg/CFR-2010-title21-vol9/pdf/CFR-2010title21-vol9-chapII.pdf. Accessed October 18, 2012.

46. Bovbjerg RR et al. State Discipline of Physicians: Assessing State Medical Boards Through Case Studies. Washington, DC: U.S. Department of Health and Human Services; February 2006. http://aspe.hhs.gov/daltcp/reports/2006/stdiscp.pdf.

Accessed November 1, 2008.

47.

Peppin J.F. Editorial; The use of methadone “as needed,” is it justified? J Opioid Manag 2009;5:7-9.