AJP Spring 2013 by Arizona Pharmacy Association

Spring 2013 Vol. 5, No. 2

Arizona Journal of Pharmacy

THE OFFICIAL PUBLICATION OF THE ARIZONA PHARMACY ASSOCIATION Brought to you by Pharmacy Network of Arizona

The Arizona Pharmacy Association and the Cardinal Health Foundation congratulate Dean Wright as the recipient of the 2013 Cardinal Health Generation Rx Champions Award! This award recognizes a pharmacist who has demonstrated excellence in community-based prescription drug abuse prevention. We celebrate Deanâ€™s outstanding efforts and commitment to raising awareness of the dangers of prescription drug abuse among the general public and among the pharmacy community. For more information about the award, visit cardinalhealth.com/GenerationRx

ÂŠ 2012 Cardinal Health. All rights reserved. CARDINAL HEALTH, the Cardinal Health LOGO, and ESSENTIAL TO CARE are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners. Lit. No. 5CR10670_AL (12/2012)

cardinalhealth.com/GenerationRx

Arizona Journal of Pharmacy

THE OFFICIAL PUBLICATION OF THE ARIZONA PHARMACY ASSOCIATION Brought to you by Pharmacy Network of Arizona

Vol. 5, No. 2

Spring 2013

In This Issue Columns

President’s Message CEO’s Message Academy News • Community Pharmacy Academy • Geriatric Care Academy • Health-System Academy • Managed Care Academy • Technician Academy • Student Pharmacist Academy

Featured Article

A Look Back - Infant Nursing Bottle

By the eighteenth century, feeders came in two types – pear-shaped and round with flat sides. Flat boat-shaped feeding bottles were the next type to appear. They had a central hole on the top to which the thumb was applied to control the flow with an opening at either end of the bottle. Feeders of this type were made of pottery, stoneware, pewter, and silver.

by Robert E. Kravetz, MD, FACP, MACG American College of Gastroenterology

Glass feeders similar in design to those made of pottery and porcelain made their appearance in the early part of the nineteenth century when glass blowing became popular and inexpensive. A specific type of bottle called the Siphonia appeared in 1864 and became known as the “Murder bottle” because of the long Indian-rubber tube attached to the nipple. The tube was a haven for bacteria and caused numerous deaths. At the height of their usage in the nineteenth century, feeding bottles resulted in the death of 7 out of 8 babies who nursed from them.

Originally infant nursing bottles or feeders were developed because of the death of the mother or her physical disability which prevented nursing. They were made in Babylon circa 2000 B.C. and pottery types were also found in Roman ruins. During the Middle Ages feeders were made from an inverted cow’s horn with an opening at the tip. In the sixteenth and seventeenth centuries, feeders were made of glazed pottery, pressed leather, or carved out of wood. Teats, or nipples, were made from calves’ teats, Indian rubber, or ivory.

The feeder illustrated here is circa 1870. It has the original hard Indian-rubber nipple. The very attractively-decorated box shows the dress of the mothers of that era.

Pharmacy Time Capsules Second Quarter 2013 1988—Twenty-five Years ago: • Average prescription cost was $16.60 according to the Lilly Digest • 40% of prescriptions were covered to some extent by third party programs, an increase of 10% over the previous year. 1963—Fifty Years Ago: • Laetrile, a purported anti-cancer drug, derived of amygdalin, an extract of apricot pits was banned by the FDA as non-effective. • Ampicillin (Polycillin) first marketed by Bristol Labs in the U.S. under license from Beecham. 1938—Seventy-five Years Ago: • APhA laboratory opens in Washington, DC, devoted to the establishment and improvement of standards for the official drugs and medicines contained in the National Formulary and the United States Pharmacopoeia

•

The March of Dimes was established by President Franklin Delano Roosevelt. The organization was originally called the National Foundation for Infantile Paralysis.

1913—One hundred Years Ago: • Fordham University (New York City) initiated a course in pharmacy. By: Dennis B. Worthen, PhD, Cincinnati, OH One of a series contributed by the American Institute of the History of Pharmacy, a unique non-profit society dedicated to assuring that the contributions of your profession endure as a part of America’s history. Membership offers the satisfaction of helping continue this work on behalf of pharmacy, and brings five or more historical publications to your door each year. To learn more, check out www.aihp.org.

Spring 2013 • Arizona Journal of Pharmacy • 17

Featured Article M.O.V.E.: a Pilot Program to Initiate Early Physical Therapy Interventions for Mechanically Ventilated Patients in an Intensive Care Unit (ICU)

by Caitlin McBee, Pharm.D., Pharmacy Resident Scottsdale Healthcare and Dyan Cherry, Pharm.D., Trauma/Neuro Critical Care Clinical Specialist Introduction Increased length of mechanical ventilation in the hospital has been strongly correlated to worse outcomes. The patient on a ventilator is at greater risk of developing Ventilator-Associated Events (VAE) like pneumonia and blood stream infections, atrophy of ancillary muscles leading to ICU-Acquired Weakness (ICU-AW), delirium, and ventilator-induced lung injury. Patients may lay immobile for extended periods of time due to weakness from underlying illness, sedatives administered, and the traditional notion that critically ill patients “need” bed rest to stabilize. Though it has been recognized for years that a more progressive, proactive approach may benefit the patients rehabilitation, not until recently was this thought challenged1. The concept of engaging the ventilated patient moves away from focusing purely on vasoactive drips, IV fluids, sedatives, and antibiotics as treatments, and allows a more comprehensive, patient-centered approach with a goal of functional rehabilitation2. In the last few years, convincing evidence has shown the short and long term benefits of physical mobilization.

Encouraging movement of critically ill patients helps prevent polyneuropathy3, myopathy, and muscle wasting1; and helps reconnect patients to surroundings. “Mobilizing” ventilated patients is inherently more complicated. Mobilization may consist of passive range of motion (ROM) or self care; or involve more elaborate movements such as strength and balance exercises or ambulation. Incorporating assisted movements helps build strength in both peripheral and respiratory muscles, which enables earlier weaning. Interventions of the physical therapist help progress patients toward these goals, and ultimately to independent functioning. These interventions, appropriately deemed MOVE (Mobilization Of Ventilated patients Early), have had compelling effects in studies. MOVE has been shown to decrease ventilation days and ICU length of stay (LOS)1,4-6 improve functional status at discharge and longterm7,8, and reduce delirium1,6. Each of these factors ultimately helps reduce rate of readmission5 through improved functional ability of the patient at discharge. With the implementation of protocols establishing specific criteria for MOVE patients, mobilization has also been found to be safe for the ventilated, critically ill patient1,9. Aside from improving outcomes, physical therapy in the ICU was also shown to be cost effective. In a study recently published in Critical Care Medicine, researchers at Johns Hopkins found that the up-front costs of physical therapy in a medical intensive care unit are outweighed by the savings of long-term benefits, such as earlier discharges from the ICU, and shorter hospital stays10.

Figure 1. Patient assessment for MOVE Basic process for patient selection into the MOVE program involves multidisciplinary rounds to assess patient’s current status and capabilities. The inclusion and exclusion criteria were initially based on the clinical judgment and study protocols2-8, and were consistently reevaluated and updated. 18 • Arizona Journal of Pharmacy • Spring 2013

Implementation at Scottsdale Healthcare The MOVE pilot program was introduced at Scottsdale Healthcare, Osborn on November 5, 2012. This involved establishing a multidisciplinary team, lead by a physician champion, consisting of nursing supervisor, pharmacists, physical therapists, and respiratory therapists. Since the program initiation, this team has rounded daily on all ventilated patients in the ICU. Each patient is reviewed for inclusion and exclusion. Respiratory therapy, pharmacy, and nursing supervisors are all responsible for certain criteria pertaining to their area of expertise. These criteria are clearly delineated in the MOVE protocol, as well as on the daily tracking sheets. Respiratory therapists are responsible for ventilation settings; where advanced vent modes such as APRV and high vent settings such as Fi02> 0.6 are reasons for exclusions. Nursing supervisors are responsible for reporting characteristics such as fractures, bleeds, wound VACs, and the patient’s cognitive abilities. The pharmacist focuses on stability of hemodynamics, and presence of vasoactive drips and sedatives. Pharmacy can help by reconciling medications to enable patients to meet criteria; something beneficial for patients regardless of ventilation status. For example, if a patient is not meeting criteria due to a lack of ability to follow commands, the pharmacist may look at medications with the potential to cause sedation, and propose lowering the dose or holding the medication. All factors reported are discussed with the team and compiled by a physical therapist, who takes this information to the physician to determine if orders for MOVE are appropriate. Once a patient has orders for MOVE, a nurse or physical therapist begins rehabilitation exercises at the stage the patient was approved. Stages 1-2 (Figure 2) may be performed by nursing since they involve passive and active ROM, as well as repositioning. Stages 3-5 have more specific exclusion criteria, such as unstable fractures and active bleeds, which limit the amount of movement that is safe for the patient. These stages require a physical therapist, and the help of a respiratory therapist to transition to a mobile ventilator. Assessing outcomes Along with the daily MOVE rounds, regular meetings with managers and

Featured Article M.O.V.E. (continued from page 18) supervisors from each area, as well as representatives from Quality Enhancement Services and Infection Control occur every two to four weeks. This process improvement group works to review the progress of the MOVE program, review outcomes data, and discuss potential improvements to the program. Outcomes data is a current focus of the process improvement group. Although the MOVE pilot is still in its infancy, comparing data from the previous year shows a trend towards decreased days on ventilation, length of stay, length of ICU stay, and readmissions. The program will also track patients’ progression through stages, and discharge disposition. Opportunities for Improvement Initially, the group noticed that there was a lack of transmission of information through departments. This was a challenge that was overcome by education at department meetings, fliers and emails, and one-on-one interactions. The largest hurdle was eradicating the traditional thought that these patients were “too sick” to be moved. Reinforcing the inclusion and exclusion criteria worked to ensure that this thought process was more objective. In literature, criteria may vary from study to study. One of the most important concepts is that, like any other guideline, the MOVE protocol is not a substitution for clinical judgment. The determination of MOVE status should be made through clear and careful communication of the multidisciplinary team.

Conclusion Implementation of the MOVE program at Scottsdale Healthcare has made a big impact. Physical therapists have commented that though family may be skeptical at first, they are extremely grateful and optimistic about the patient’s progress once the process begins. A few family members have shed tears of joy, in awe of the accomplishments. This impact is seen not only with patient care, but also with the health care providers involved. Many health care professionals have also noticed that the rounds are improving relationships between disciplines and encouraging educational conversations. Furthermore, feedback relayed from nursing to respiratory and physical therapy on patient’s positive attitudes after MOVE sessions reinforces the main initiative of providing patient-centered care. References 1. Schweikert and Kress. Implementing Early Mobilization Interventions in Mechanically Ventilated Patients in the ICU. CHEST 2011; 140(6): 1612–1617. 2. Thomsen GE, Snow GL, Rodriguez L, Hopkins RO. Patients with respiratory failure increase ambulation after transfer to an intensive care unit where early activity is a priority. Crit Care Med. 2008; 36(4): 1119-1124. 3. Fan E. Critical illness neuromyopathy and the role of physical therapy and rehabilitation in critically ill patients. Respir Care 2012; 57(6): 933-44.

4. Morris PE, Goad A, Thompson C, et al. Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med. 2008; 36(8): 2238-2243. 5. Needham DM, Korupolu R, Zanni JM, et al. Early physical medicine and rehabilitation for patients with acute respiratory failure: a quality improvement project. Arch Phys Med Rehabil. 2010; 91(4): 536542. 6. Ronnebaum J, Weir J, Hilsabeck T. Earlier Mobilization Decreases the Length of Stay in the Intensive Care Unit. J of Acute Care Physical Therapy, 2012; 3(2): 204-210. 7. Burtin C, Clerckx B, Robbeets C, et al. Early exercise in critically ill patients enhances short-term functional recovery. Crit Care Med. 2009; 37(9): 2499-2505. 8. Schweickert WD, Pohlman MC, Pohlman AS, et al. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial Lancet. 2009; 373(9678): 1874-1882. 9. Bailey P, Thomsen GE, Spuhler VJ, et al. Early activity is feasible and safe in respiratory failure patients. Crit Care Med. 2007; 35(1): 139-145. 10. Lord R et al. ICU Early Physical Rehabilitation Programs: Financial Modeling of Cost Savings. Crit. Care Med. 2013; [Epub ahead of print].

Patient case #1: The first MOVE patient progressed quickly, first sitting on the edge of the bed, then ambulating down the hall. He was extubated shortly after being enrolled in MOVE, and continued to improve. The smile of gratitude on his face during MOVE sessions was not only enough to confirm the programs worth, but also enough to suggest a potential increase in patient satisfaction.

Figure 2. MOVE stages and selection Spring 2013 • Arizona Journal of Pharmacy • 19

Featured Article Pharmacists on a Mission of Mercy

by Rebecca Ramsey, Pharm.D. Candidate 2013 and Elizabeth Pogge, Pharm.D., MPH, BCPS, FASCP, Assistant Professor, Midwestern University College of Pharmacy-Glendale When most people think of dental work, they may think of dentists, hygienists, or orthodontists, but pharmacists? However, at the Arizona Dental Mission of Mercy (AZMoM) event held at the Arizona State Fairgrounds in Phoenix December 7-8, 2012, professionals from dentistry and pharmacy worked hand in hand to help patients in need. The two-day Mission of Mercy event, hosted by the Central Arizona Dental Society Foundation, saw 1,659 men, women, and children receive over $1.28 million of free dental care, including cleanings, extractions, fillings, and root canals, from over 1,500 volunteers. Running from 6am to 6pm over these two days and seeing this volume of patients, Arizona Dental Society Foundation spokesperson Dr. Mark Hughes stated that this Mission of Mercy event was one of the largest events held in the country.1 According to the Mission of Mercy website, 44% of adults and 38% of children in Arizona lack dental insurance.1 Many of these patients end up utilizing the emergency room for dental treatments. Since the emergency room often lacks the proper resources to take care of these issues, long-term oral health problems aren’t treated properly. Some dentists volunteering for this event pointed to the burden of dental-related emergency room visits that occur due to patients’ lack of access as an important reason for volunteering for AZMoM.1 Other dentists volunteered for the event after noticing a decline in patient checkups.2 No matter the reason, having all of these professionals volunteer their expertise allowed these patients to finally receive the proper dental treatment that they needed and would not otherwise receive. Some patients called this opportunity to finally have relief from their dental concerns an early Christmas present. In fact, long lines and hours of waiting for treatment did not dampen these patients’ enthusiasm for the event. One mother of two who waited in line with her children so that they could all receive dental work stated “We would have waited much longer than four hours to get this done. We are grateful”2. Another patient stated, “It’s a beautiful thing that they’ve done for us. They were respectful, compassionate, and caring”1.

Patients receiving dental care at Mission of Mercy

20 • Arizona Journal of Pharmacy • Spring 2013

Jane Abrams, Nhung Luong, Nicole Romney, & Irene Coon fill prescriptions in the pharmacy. At the event, patients waited in line to get evaluated on their dental needs, and were then sent to stations to receive the appropriate dental care. After their procedures, many of these patients needed post-surgical prescriptions filled. These prescriptions were for medications such as amoxicillin and clindamycin for antibiotic prophylaxis, and acetaminophen and ibuprofen for pain relief. This is where the twelve faculty and students of Midwestern University College of PharmacyGlendale stepped in to volunteer their services. The pharmacy department for AZMoM, led by Dr. Elizabeth Pogge, an assistant professor at Midwestern University, obtained medication orders from dentists. The pharmacy department checked for drug allergies to the prescribed medications and counseled patients on the medications being dispensed. They also reviewed the patients’ medication and health history, screening for drug or disease interactions and made interventions when appropriate. By having pharmacy volunteers at the event, the dental mission decreased the likelihood of any patients receiving inappropriate medications due to allergies, of taking the medications inappropriately, or of having drug-drug interactions with other medications that the patients were taking. The Arizona Mission of Mercy was a success due to the combined efforts of over 1,000 volunteers who through a multi-disciplinary approach were able to use their expertise to ensure that these patients received the help they needed. From the dentists and hygienists performing the procedures, to the pharmacists dispensing and counseling on the prescriptions, all of the event’s volunteers were able to make a difference in the lives of thousands of people. It truly was a Mission of Mercy. References: 1. Cole, Chris. Arizona dentists give free care to low income patients. Azcentral. com Dec 7 2012. http://www.azcentral.com/news/articles/20121207arizonadentists-free-care-low-income-patients.html?nclick_check=1. 2. Lempert, Monica. Over 1,500 dental professionals volunteer treatment for first Arizona Dental Mission of Mercy. ABC 15 News. Dec 7 2012. http://www.abc15. com/dpp/news/region_phoenix_metro/central_phoenix/1500-dental-professionalsvolunteer-treatment-for-first-arizona-dental-mission-of-mercy

Featured Article Bronchodilators Effective in the Treatment of RSV in Children: Fact or Fiction? by Tijana Gligorevic, Pharm.D., PGY-1 Pharmacy Practice Resident, Maricopa Integrated Health System (MIHS); Erica Domer, Pharm.D., Clinical Pediatric Specialist, MIHS/AzPA Health-System Academy

Bronchiolitis is the most common viral lower respiratory tract infection in infants, characterized by acute inflammation, edema and necrosis of epithelial cells lining the small airways, increased mucus production, and bronchospasms. Infants typically present with rhinitis, tachypnea, wheezing, cough, crackles, use of accessory muscles, and nasal flaring. The most common viral cause of bronchiolitis is respiratory syncytial virus (RSV). Ninety percent of children are infected with RSV in the first two years of life, and up to 40% of them will have a lower respiratory infection.1 In a recent prospective, population based surveillance study of acute respiratory infections in children under five years of age, the authors found that of the 5,067 children enrolled in the study, 18% had RSV infections. In the same study, RSV was associated with 20% of hospitalizations, 18% of emergency department visits, and 15% of office visits over a period of six months, accounting for significant morbidity associated with the infection.2 Treatment of RSV infection is mostly supportive, consisting of observation, supplemental oxygen, and nasal suctioning as needed. Though the American Academy of Pediatrics (AAP) states that bronchodilators should not be used routinely in the management of bronchiolitis, this recommendation is not always followed in practice.1 The use of bronchodilators in the management of RSV bronchiolitis is a topic to be further discussed in the remainder of this drug information response. There are several studies which support the use of bronchodilators in the treatment of acute bronchiolitis.3,4,5 A randomized double-blind clinical trial by Klassen et al., enrolled 83 children (median age 6 months, range 1 to 21 months) with acute bronchiolitis. Participants received two treatments at 30 minute intervals of either nebulized albuterol or a similar volume of normal saline. The authors measured respiratory rate, pulse oximetry, and a clinical score based on the degree of wheezing and retractions. They found that the patients in the albuterol arm had significantly greater improvement in clinical scores after the initial treatment (p=0.04), which was 30 minutes after the first dose was administered. However, no differences between groups were found after 60 minutes (p=0.08). In addition, there was no difference between the groups in oxygen saturation (p=0.74) at any point during the study. They also found a slight, though statistically significant, increase in heart rate in the patients in the albuterol group (159 beats per minute (bmp) ± 16 versus 151 bpm ± 16; p=0.03).3 The authors’ conclusion that albuterol was safe and effective for the initial treatment of acute bronchiolitis in young children is not supported by the results of their study since there were no differences in clinical outcomes at 60 minutes after the first dose was administered, no differences in oxygen saturation at any point in the study, and a significant increase in heart rate.3 In another double-blind placebo-controlled trial by Schuh et al., 40 infants between 6 weeks and 24 months of age who had symptoms of bronchiolitis were enrolled. Participants received

either nebulized albuterol or placebo, each administered for 2 doses at 1 hour intervals. RSV was eventually diagnosed in 71% of the participants. They found that those in the albuterol group had significantly greater improvement in accessory muscle use (p=0.03) and oxygen saturation (p=0.01) after one dose, as well as improvement in respiratory rate (p=0.016) after two doses. The results were similar for patients less than 6 months of age and for patients older than 6 months of age. The heart rate was increased significantly more in the albuterol group after 2 doses (p=0.003). The authors concluded that administration of nebulized albuterol was safe and effective in the treatment of acute bronchiolitis.4 In a final prospective nonrandomized study by Derish et al., 25 infants who required intubation and mechanical ventilation secondary to RSV infection were enrolled. Pulmonary function tests were performed before and 20 minutes after inhalation of 20 to 40 breaths of nebulized albuterol. Maximum expiratory flow at functional residual capacity increased significantly in the albuterol group from 48 ± 46 mL/sec to 65 ± 59 mL/sec (p=0.03). However, only 3 patients had an increase into the normal range for functional residual capacity and 3 patients substantially deteriorated post albuterol administration with a 40-50% decrease in the functional residual capacity. The authors stated that they were unable to predict which infants would deteriorate rather than improve based on the past medical history, which makes the administration of a bronchodilator rather risky.5 As noted by the AAP, the routine use of bronchodilators in the treatment of RSV is not recommended secondary to lack of evidence for its use in randomized controlled trials. There are several trials which show that albuterol is no more effective than placebo.6,7,8,9 In a retrospective study, 316 full term infants (ages 11 to 90 days) who were hospitalized for RSV bronchiolitis were included. The study patients were divided into five severity groups (0 to 5, with 5 being the most severe) based on their clinical presentation. Those who received albuterol required more time on supplemental oxygen and had longer length of stay, though the difference was statistically significant in only one of the severity groups (2).6 In a double-blind placebo-controlled randomized trial by Dobson et al., 52 patients less than 24 months of age with a diagnosis of moderately severe RSV bronchiolitis received either nebulized albuterol or normal saline for 72 hours under a standardized protocol. The study was adequately powered at 90% and the authors found no difference in the oxygen saturation (p=0.84) or length of hospital stay (p=0.24) between the two groups.7 Another randomized, double-blind, placebo-controlled trial divided 88 infants (median age 5.5 months) treated for their first episode of wheezing into four groups: nebulized albuterol (n=22), nebulized saline (n=23), oral albuterol (n=19) and oral placebo (n=24). The nebulized groups received two treatments at 30 minute intervals and the oral groups received one oral dose. The authors found no differences in respiratory rate, oxygen saturation, need for additional treatment, need for hospitalization, or clinical score between any of the groups at 30 and 60 minutes after the first dose was administered. However, there was a significant increase in heart rate in the oral albuterol group when compared to the other groups (142 bpm ± 16 versus 157 bpm ± 33; p=0.005).8 In another randomized double-blind trial, 120 patients less than 2 years old who were admitted for signs and symptoms consistent with a clinical diagnosis of bronchiolitis Arizona Journal of Pharmacy • Spring 2013 • 21

Featured Article Bronchodilators (continued from page 21) (i.e., tachypnea, crepitation and wheezing) were enrolled. From the study population, 42% of the patients had confirmed RSV. Study participants were randomized to receive nebulized albuterol, ipratropium, or normal saline, or oxygen without nebulization. The authors found no significant differences between the four groups in terms of a severity score (a measure of respiratory rate, presence of subcostal retractions, crepitations and wheezing), number of nebulization treatments required, or length of hospitalization (p>0.05 for all).9 Conclusion: Bronchiolitis is a viral respiratory infection which affects mostly infants and is associated with high morbidity in that patient population. It is therefore important to optimize therapy to ensure the best outcomes. The AAP recommends supportive treatment consisting of observation along with oxygen and nasal suctioning as needed. The role of bronchodilators is unclear, though not recommended by the AAP. The literature presented above supports the stance of the AAP against the routine use of such agents. Most of the studies reviewed found no greater benefit with the use of bronchodilators than with placebo. However, a majority of the studies reviewed had relatively small sample sizes with an average of about 100 patients per study. Exclusion criteria for most of the included literature consisted of patients with congenital heart disease, history of prematurity, concurrent severe illness such as sepsis or meningitis or pneumonia, baseline tachycardia, or history of previous bronchodilator therapy. Based on the exclusion criteria, the results apply to healthy patients with no significant past medical history whom are being treated for an initial episode of bronchiolitis. Patients requiring mechanical ventilation were excluded from all but one of the studies which specifically focused on that patient population. None of the trials reviewed looked at long term outcomes. Albuterol use is not without risk, as prolonged use of albuterol may contribute to hypertension, irregular heart beat and bronchospasm. In addition, excessive use of albuterol may decrease the effectiveness and the response to albuterol if needed for future bronchoconstrictive conditions. Bronchiolitis is not a bronchoconstrictive condition. Pathologic changes associated with bronchiolitis include bronchial edema and inflammation, neither of which is responsive to albuterol.4 Based on an assessment of the literature and practice guidelines, it is recommended to avoid the routine use of bronchodilators in the treatment of RSV bronchiolitis. However, utilizing clinical discretion and a risk versus benefit assessment, it may be reasonable to administer a test dose of a nebulized bronchodilator and evaluate clinical response as a last effort in a patient who is not otherwise improving with only supportive care. If the patient responds positively, it may be appropriate to continue during the acute phase of the illness. References: 1. Lieberthal AS, Bauchner H, Hall CB, et al. Diagnosis and management of bronchiolitis. Pediatrics 2006;118:1774-1793. 2. Hall CB, Weinberg GA, Iwane MK, et al. The burden of respiratory syncytial virus infection in young children. N Engl J Med 2009;360:588-98. 3. Klassen TP, Rowe PC, Sutcliffe T, et al. Randomized trial of 22 â€˘ Arizona Journal of Pharmacy â€˘ Spring 2013

salbutamol in acute bronchiolitis. J Pediatr 1991;118(5):807811. 4. Schuh S, Canny G, Reisman JJ, et al. Nebulized albuterol in acute bronchiolitis. J Pediatr 1990;117(4):633-637. 5. Derish M, Hodge G, Dunn C, Ariagno R. Aerosolized albuterol improves airway reactivity in infants with acute respiratory failure from respiratory syncytial virus. Pediatr Pulm 1998;26:12-20. 6. Del Vecchio MT, Doerr LE, Gaughan JP. The use of albuterol in young infants hospitalized with acute RSV bronchiolitis. Interdisciplinary Perspectives on Infectious Diseases 2012;1-4. 7. Dobson JV, Stephens-Groff SM, McMahon SR, et al. The use of albuterol in hospitalized infants with bronchiolitis. Pediatrics 1998;101:361-368. 8. Gadomski AM, Lichenstein R, Horton L, et al. Efficacy of albuterol in the management of bronchiolitis. Pediatrics 1994;93:907-912. 9. Goh A, Chay OM, Foo AL, Ong EK. Efficacy of bronchodilators in the treatment of bronchiolitis. Singapore Med J 1997;38(8):326-328.

Feature Pharmacist One Who Defines Innovation in Pharmacy

by Asal Azizoddin, Pharm.D. Candidate, Midwestern University College of Pharmacy-Glendale, Class of 2014 Keith Cook, R.Ph. is the president of Avella Specialty Pharmacy (formerly The Apothecary Shops) in Phoenix, Arizona. As a leader in this branch of pharmacy, he guides Avella to serve patient populations in need of medication therapy for oncology, rheumatology, fertility, and HIV/AIDS just to name a few. Mr. Cook received his pharmacy degree at Kansas University in 1980 and began his career in the hospital setting. Six years later, he made a leap into the retail side in order to have a more balanced lifestyle with family and work. Mr. Cook worked for Walmart for 23 years starting as a pharmacy manager followed by many other positions, such as working as a district manager, working in the corporate office, running the private label PBM business, being a supervisor of the mail order facility, and opening a specialty pharmacy in Orlando, Florida. After retiring with Walmart, he worked for Cardinal Health on the Medicine Shoppe and Medicap franchises for three years as a vice president of clinical pharmacy. Four years ago he joined the team of Avella Specialty Pharmacy, formerly known as The Apothecary Shops. What motivated you to become a pharmacist? I knew I wanted to do something in the medical field. My strengths were in math and science so I looked for careers where I could use my skills and be in a position to help people. Pharmacy was a great choice! How has the pharmacy profession changed during your career? When I first started practicing pharmacy, cash sales made up 90% of the business and managed care (third party) was 10%. On the hospital side, it was before prospective payment – we billed what we felt was correct and the insurance company paid the bill. Things are a little different today where over 90% of the business is contracted managed care claims and cash is just a small piece. The other big change has been the growth and acceptance of generics. These were still fairly new in the 1980’s and the public had not yet fully accepted the idea that the “generic” drug was equivalent to the brand name. That change occurred slowly and with the improvement in the generic quality, we have seen significant changes in our pharmacy businesses today. Lastly, the idea of “direct to consumer” advertising was unheard of when I graduated from school and first started to practice. The general public had very little knowledge of drug products and relied completely on the decision of the physician to make the correct decision about their therapy. Good or bad, patients are now bombarded with commercials and advertising about their disease state and the “best therapy” for them. Patients are more informed and are now requesting medication based on what they have read or seen on television.

What changes do you foresee for the profession of pharmacy? There will be more emphasis around payer reimbursement and decreasing margin. Everyone will have to watch this closely to remain a viable part of the health care process. Expect more automation. We have not begun to tap the technology that our industry will see in the future. I suspect that pharmacy in 15 years will look totally different than it does today, as we will see the elimination of manual processes, more automation, and more time for the pharmacist to be focused on outcomes for the patient. What is your favorite part of your current position with Avella? Working with the employees and exceeding the needs of our patients—those two things make it fun to come to work every day. Where do you find or whom do you approach for innovative ideas for the company? We watch the industry closely. What are our competitors doing? We also look inwardly and constantly look for ways to improve. We attend industry trade shows and meetings where we can see the latest and greatest technology in the pharmacy industry. Change is constant in our business and you have to stay on top of it if you want to remain competitive. What is your intake on residencies? Does your company offer any? We support residencies and have had some great residents over the past few years. I believe over the past 3 years, we actually hired 100% of the residents after they finished the program, so we believe in the concept. Our concerns have been over the fact that the only certification for residency programs is through ASHP and some of the requirements don’t easily fit into our business. We are considering a residency program that would be fully sanctioned by Avella in the future. Are you a member of any other state or national organizations? In addition to AzPA, we belong to NCPA and NACDS as well as NCPDP. All are important as we seek to be actively involved in the pharmacy industry. Why is being a member of the Arizona Pharmacy Association important to you? Alone, I am only one voice. As a member of AzPA, I am part of a group that has enough volume to make a difference in the practice of pharmacy. AzPA also provides me with industry and state updates that keep me informed of current issues I need to be aware of.

Keith Cook, R.Ph., President Avella Specialty Pharmacy Arizona Journal of Pharmacy • Spring 2013 • 23

Student Perspective PD@C

by Brian McKinley, Pharm.D. Candidate Class of 2013, University of Arizona College of Pharmacy On January 23, 2013, students from Midwestern University and University of Arizona and pharmacists from across the state converged in Phoenix for the annual Pharmacy Day at the Capitol. This event showcases pharmacists’ abilities to positively impact health care to legislators and to show what we provide as a profession. As we all know, advocacy for the profession is paramount for advancing pharmacists into a more respected health care role and this event is one way of promoting the profession. As lunchtime approaches, legislators and staffers visit the lawn area and are greeted by a pharmacy student. The student then takes him or her around the various booths showing what a pharmacist does in daily practice. This year booths included blood sugar screenings, tobacco cessation information, influenza immunizations, blood pressure screenings, poison center information, and many others. By the end of the tour, the visitor has surely seen the broad scope of a pharmacist’s practice and hopefully will keep this in mind when creating future legislation. Throughout the event I notice the enthusiasm Midwestern University and University of Arizona students have at their booths and appreciate how they are promoting pharmacy so well together. During the event I had the chance to speak with pharmacists who drove to Phoenix just for this event. J.P. Webb, a first-year resident at North Country HealthCare in Flagstaff, Arizona said, “The turnout today was amazing. AzPA is doing a great job of educating legislators about what pharmacists are capable of and what they can do going forward.” There were also quite a few pharmacists from Tucson that made the commute and as you might expect, Jim Kloster, AzPA PharmPAC Chairman, was one of them. With his usual zest for pharmacy, he explained, “It’s a Photo at left: AzPA Member Mindy Burnworth, Pharm.D., talks with House Speaker Andy Tobin. Bottom photo: Ryan Gries, Pharm.D. Candidate, Midwestern University, checks a legislative staffer’s blood pressure.

Top Photo AzPA Member Jim Kloster talks with State Representative Jonathan Larkin, C.Ph.T. Bottom photo: Craig McDade, R.Ph. confers with AzPA Member and Arizona State Board of Pharmacy President Tom Van Hassel

good way to meet and greet some of our legislators. The students are very excited about their futures and they’re projecting that. It makes pharmacy a very vibrant and important profession.” Afterwards, fellow student Amanda Dawes and I shadowed AzPA CEO Kelly Ridgway in the House and Senate to listen to hearings of bills that could impact pharmacy. In this legislative session, there are a few bills that have some relevance to pharmacy, so it’s important to keep abreast of these bills as the legislative process continues. Seeing members of the legislature in action was, surprisingly, interesting and worthwhile. It’s easy to see how long the process of transforming an idea into actual legislation can take when all parties begin to voice opinion and later, to appreciate all the hard work put in when a law is finally enacted. I’ve had the opportunity to participate in this event three out of my four years in pharmacy school and each year seems to get better and better. The students are always so eager to speak about the profession and to explain why pharmacy needs to be at the forefront of legislation. One quote I remember from my first year of pharmacy school is, “Get into politics or get out of pharmacy” and that is exactly what this event aims to accomplish. As a profession, we need to be at the table when health care legislation is created and follow it through to completion. In the past, I think we’ve seen pharmacy take a back seat when health care topics are discussed and I hope that’s finally changing. With this event and many others across the nation, it seems that pharmacy is now making great strides to be near the forefront of legislation and I hope this trend continues. Editor’s Note: Check out the video from PD@C on the AzPA YouTube channel at http://www.youtube.com/watch?v=oHBq5TDgS_I

24 • Arizona Journal of Pharmacy • Spring 2013

Inaugural Southwest Pharmacy Symposium by Amanda Dawes, Pharm.D. Candidate 2013 Midwestern University College of Pharmacy-Glendale

Student Perspective did learn about PPMIs, preconception health, and prescription drug abuse for example, what I really learned came from all of the individuals that filled the auditorium. There, in each seat, sat a pharmacist or student pharmacist, drenched from an early Saturday morning rainstorm, just to expand their knowledge of pharmacy. What I learned was just how dedicated the pharmacy community is to the profession. From the presenters who undoubtedly spent numerous days preparing for the event to the pharmacists and student pharmacists who gave up one of their rare days off to expand their knowledge, these individuals were an inspiration. What I took away from this event is that dedication to the profession goes beyond the hours spent in the classroom or days spent in a pharmacy. It is the extra time spent at events such as this that really showcases a commitment to the profession of pharmacy. I am excited to call these individuals my colleagues and I am even more excited to see them at future events.

Saturday January 26, 2013, marked the date of the Inaugural Southwest Pharmacy Symposium presented by the Arizona Pharmacy Foundation and Pharmacists Assisting Pharmacists of Arizona. Despite a record-breaking downpour, I, along with over 75 dedicated pharmacists and student pharmacists, attended the event in which we were all given the opportunity to partake in six interactive programs concerning today’s world of pharmacy. These presentations included: “The Update on the Pharmacy Practice Model Initiative” presented by ASHP President Dr. Kathryn R. Schultz; “Is It Possible to Start Before the Beginning? Pharmacists and Preconception Health” presented by Merry-K. Moos, BSN and Cathy Schechter; “The Brain Disease of Addiction” sponsored by Pharmacists Assisting Pharmacists of Arizona and presented by Jim Corrington, MSW; “Oral Adherence to Cancer Therapies” sponsored by Celgene and presented by Andrea Montoya; “NASPA-NMA Student Pharmacist Self-Care Championship” led by Dr. Grace Akoh-Arrey and Dr. Betty Louton; and “Prescription Drug Abuse Prevention Workshop: How you can help prevent prescription drug abuse in the community” presented by Michael A. Moné, R.Ph., J.D. I believe all in attendance would agree that these presentations were not only informative and thought provoking but also provided the tools necessary to implement the unique ideas presented into each pharmacist’s practice setting. Although these presentations were the focus of the event, three important accolades were given during this time as well. Dean Wright, R.Ph. of the Arizona State Board of Pharmacy accepted the Cardinal Health GenerationRx Champions Award. This award honors a pharmacist who has demonstrated an outstanding Steve LeMahieu, commitment to raising awareness of the dangers of prescription APF President and drug abuse among the general public and among the pharmacy Mike Dietrich, AzPA community. Two students were also recognized at the event. President, award the Llyn Lloyd Asal Azizoddin of Midwestern University and Jessica DiLeo of Scholarship to University of Arizona both received the Llyn Lloyd Service to Jessica DiLeo, Pharmacy Scholarship Award. Finally, Midwestern University UofA COP (center). walked away with the inaugural win and trophy in the NASPANMA Student Pharmacist Self-Care Championship. Overall, the event was a great success. I personally expanded my knowledge in several different areas and I undoubtedly will be applying this information in my future practice. However, I believe the knowledge I gained from this experience goes beyond that of the information in the presentations. Although I

Brian Willis, Cardinal Health and Hal Wand present Dean Wright (center) with the GenerationRx Champions Award.

Steve LeMahieu, APF President and Mike Dietrich, AzPA President, recognize Llyn Lloyd Scholarship winner Asal Azizoddin, MWU-CPG (center).

NASPA OTC Challenge winners representing MWU-CPG (left to right): Amanda Dawes, Debora Pereira (Creighton University), Nicole Vacek-Wilson, Matt Aronson, Ronni Nemeth, Asal Azizoddin. Spring 2013 • Arizona Journal of Pharmacy • 25

Academy News Community Pharmacy Academy Spring is one of my favorite times of year! It’s such a bright, fun time. Everyone starts dusting off the cobwebs and seems vibrant and new again. I am really looking forward to all of the CE’s that AzPA is offering in the upcoming months! The AzPA Annual Convention is June 27th-30th at the Westin La Paloma in Tucson. Starting out on Thursday, June 27th there will be two certificate programs offered for you to choose from. I recently completed the AzPA Psychiatric Certificate Program and was very impressed with the speakers and the quality of the program, definitely one you don’t want to miss! Another area that is sure to add value to your practice is the MTM Training Program. The programming continues through the weekend and as always there will be several activities specially geared toward community pharmacy practice. New this year is an Independent Pharmacy Owners Track on Sunday, June 30, 2013, featuring 6.0 contact hours (0.60 CEUs) of programming focusing on business strategies and Arizona pharmacy law updates. Be sure to visit the AzPA Annual Convention & Trade Show web page at www.azpharmacy.org/2013_Convention! If you are interested in becoming more involved within the Community Pharmacy Academy NOW is the TIME!! Ballots for the Chair-elect position will be coming out soon. In case you didn’t know the CPA also has its own Executive Committee and we are always looking for ambitious, motivated individuals to get involved and represent the academy on various AzPA standing committees. Please feel free to email me with any questions!

Kristin Calabro, Pharm.D. Community Pharmacy Academy Chair cpa@azpharmacy.org

Geriatric Care Academy The Geriatric Care Academy (GCA) leadership is excited to announce the Geriatric Pharmacy Roundtable: A Focus on Geriatric Pharmacotherapy will be held on Friday, May 3, 2013 from 2:00pm - 5:30pm at Midwestern University in Glendale, Arizona. The CE sessions will be in a unique and engaging format –allowing for small group interaction and networking opportunities. Roundtable discussions on various geriatric topics will be approximately 30 minutes in length. The presentation is interactive and given in a short lecture format (~20 minutes) followed by discussion (~10 minutes). The topics are centered on issues concerning the geriatric patient population including infectious disease and psychiatric updates as well as a statistics refresher. AzPA has already begun advertising and registration is open! Hope to see you there! GCA’s monthly conference call is the second Wednesday of each month at noon (January – May 2013) with the next call May 8, 2013 at 12:00pm. Contact the AzPA office for Call-in information. Please call in to have your voice heard! The American Society of Consultant Pharmacists Spring Conference is May 14-17, 2013 in Orlando, FL. Go to www.ascpspringconference.com to register. As always, I am interested in new ideas for how to best serve the academy. If you have any ideas or questions please feel free to contact me. Sincerely,

Geriatric Pharmacy Roundtable: A Focus on Geriatric Pharmacotherapy Friday, May 3, 2013 2:30 PM TO 5:30 PM Tara Storjohann, Pharm.D., CGP, FASCP Geriatric Care Academy Chair gca@azpharmacy.org

Presented by the AzPA Geriatric Care Academy Midwestern University College of Pharmacy Glendale 19555 N. 59th Avenue, Glendale, AZ 85308 Visit www.azpharmacy.org to register

26 • Arizona Journal of Pharmacy • Spring 2013

Academy News Health-System Academy News What an exciting year 2013 has been thus far for the pharmacy profession. Pharmacist provider status is a crucial issue that has garnered national attention, seems to be gaining positive political traction, and is sparking intense discussion both at the state and national level – this is great news! Our Arizona representatives serving on the ASHP House of Delegates (HOD) will be discussing this issue in full force come May and June at the Regional Delegate Conferences and ASHP Summer meeting. Recognizing the value of pharmacists as medication experts and the reality that we are the “most underutilized health care professional” has the potential to improve patient care and advance our profession… a “win, win” situation! The AzPA HSA continues to add value to Arizona pharmacy through member engagement, planning timely continuing-education programs, participating in student mentorship through the AzPA Mentor Connection Program, conducting ASHP HOD nominations and elections, contributing articles and continuing education self-studies to AJP, partnering with ASHP to move the Pharmacy Practice Model Initiative (PPMI) forward in our state, and working with all national pharmacy organizations to gain support for pharmacists as providers. The AzPA Spring Clinical Conference, hosted by the HSA, will be held at Banner Desert Medical Center on Saturday, April 27, 2013. This year’s theme is “Team Healthcare: Collaboration for Improvement in Patient Outcomes.” The topics were carefully chosen and will provide you with information that is pertinent and relevant to your practice and our profession, ranging from the treatment of rare yet interesting diseases to demystifying line access to residency preceptor development and finally pharmacy law and federal legislative affairs. You won’t want to miss this event! If you haven’t already registered – don’t delay! https://m360.azpharmacy.org/ event.aspx?eventID=63090 The HSA continues to brainstorm ways to educate, encourage, and facilitate participation of all health-systems with ASHP’s PPMI. In the Winter edition of AJP I wrote about PPMI in my Chair message and in this issue I wrote about the Health-System Leaders Forum Luncheon that took place in January where we discussed PPMI with key stakeholders in Arizona pharmacy (see page 10.) The HSA is interested in organizing an AZ PPMI State Leadership Task Force – if you or someone you know would be interested in serving on such a task force, please email me. Arizona pharmacy is doing great things but there is still work to be done; perhaps involvement with the PPMI can help to achieve your institution’s goals. To learn more about the Pharmacy Practice Model Initiative, visit ASHP’s website at http://www.ashpmedia.org/ppmi/index.html. I would love to hear from you regarding how the HSA can help YOU advance YOUR practice in 2013. Without your input our academy can’t meet your needs, goals or expectations. Please email me at hsa@azpharmacy.org or post your thoughts on the AzPA HSA Forum located on the AzPA website. The weather is heating up – time to enjoy our beautiful outdoors!

AzPA Spring Clinical Conference

Warm regards,

brought to you by the AzPA Health-System Academy

Lindsay Davis, Pharm.D., BCPS Health-System Academy Chair hsa@azpharmacy.org The Health-System Academy of the Arizona Pharmacy Association is the Arizona affiliate of the American Society of Health-System Pharmacists (ASHP).

Saturday, April 27, 2013 Banner Desert Medical Center Rosati Education Center 1400 S. Dobson Road Mesa, AZ 85202 The continuing education activities associated with the Spring Clinical Symposium are eligible for a total of 6.5 hrs. (0.65 CEUs) of continuing pharmacy education.

go to www.azpharmacy.org Spring 2013 • Arizona Journal of Pharmacy • 27

Academy News Managed Care Academy News The AzPA Managed Care Academy continues to have our monthly conference calls. We will have an open meeting in June at the annual conference. We are considering ideas for networking events and what to do for our next conference. We were happy to host a meet and greet event at the 25th AMCP Expo in San Diego, California in April. It is always a good time to network with fellow pharmacists and students. If you haven’t tried volunteering lately, please consider it in the future. Several of us volunteer for the Tour de Cure in either Phoenix or Tucson and this year was no exception. The weather was excellent and it was a fun way to spend the day. Thank you again to the pharmacy students that volunteered to help the American Diabetes Association with the medical tents at the Tour De Cure rides. Just a reminder to everyone that there are fun and easy ways to help AzPA. Gift cards can be purchased from the office with no service fee to you and AzPA will receive a portion of the proceeds. Also if you go to our website, you can enter Amazon.com through a panel on the right-hand side. You won’t see any difference and again a portion of the amount spent will go directly to AzPA. You must enter Amazon through our website at www.azpharmacy.org for this opportunity to work. Please consider these opportunities to give something to AzPA while you are doing your shopping. Graduations, Mother’s Day, Father’s Day, etc. are all approaching fast. I would like to thank the many volunteers that have answered the call to fill committee opportunities on behalf of our academy and their dedication to meet the needs of the academy and AzPA. If you are interested in becoming more involved in MCA please let Eric Luecht and I know. We are more than happy to find a place to get you more plugged in. Also we are always looking for volunteers to write articles for consideration to be included in this journal. Thank you and Happy Spring to all of you!

Ann Sears, R.Ph. Managed Care Academy Chair mca@azpharmacy.org

Technician Academy News The Pharmacy Technician Certification Board (PTCB) is introducing new requirements to the process of obtaining and maintaining the certified pharmacy technician (C.Ph.T.) credential. PTCB’s certification requirements have been essentially unchanged since 1995, when the organization was founded. The revised certification plan will allow technicians to assume greater responsibility for distributive processes, which will allow pharmacists to spend more time taking care of patients. PTCB is accepting comments on its plan through May 2013. The organization wants to hear from a variety of stakeholders, including pharmacists, pharmacy technicians, state pharmacy boards, professional associations, and employers. Go to www.ptcb.org to comment. Once the changes are fully implemented, new applicants for PTCB’s C.Ph.T. credential will be required to pass a criminal background check and complete an ASHP-accredited technician education program. PTCB has proposed a 2014 implementation date for the background checks and expects the training program requirements to be in place in 2020. Recertification will undergo changes as well, including the phasing out of in-service education programs and a decrease in the number of continuing education (CE) hours obtained through college classes. Pharmacy technicians must recertify every two years to keep their C.Ph.T credential. For recertification starting in 2015, technicians will need to complete 20 hours of pharmacy technicianspecific CE that includes 1 hour of pharmacy law—a current requirement—and, starting in 2014, 1 hour of medication safety CE.

Joy Davis, C.Ph.T Technician Academy Chair tech@azpharmacy.org

28 • Arizona Journal of Pharmacy • Spring 2013

Academy News Student Pharmacist Academy News To start off the new year, over 60 students from the University of Arizona traveled north to collaborate with 65 students from Midwestern University at Pharmacy Day at the Capitol. Students had the opportunity to interact with legislators while advocating for the pharmacy profession. The student academies also had a great turn out at the first annual Southwest Pharmacy Symposium where ten students from the University of Arizona and 16 students from Midwestern University attended. Students participated in an OTC Jeopardy Challenge where the University of Arizona lost a hard fought battle against Midwestern University. Midwestern University was awarded the traveling trophy and a rematch has been scheduled at the AzPA Annual Convention in June! The Student Pharmacist Academy at the University of Arizona has spent the past few months participating in new activities and events. For the first time, students participated in the Tour de Cure Tucson event hosted by the American Diabetes Association. Students volunteered at rest stops and provided first aid care to bicyclists. Also for the first time, six students from the University of Arizona took Katy’s Kids to Wildcat Elementary School in Tucson. A second grade class learned about the role of the pharmacist by rotating through different stations. Stations included hospital pharmacy, community pharmacy, compounding pharmacy, poison control center, and an activity station. The elementary kids loved the pharmacy students and the teacher has invited us back for next year. The Student Pharmacist Academy at Midwestern University has been focused on getting involved in the community. In January, 26 student academy members helped the City of Glendale pick citrus at Sahuaro Ranch Park as a part of Project Vitamin C. Students worked with other volunteers from the community to pick over 10 tons of citrus to donate to the St. Mary’s Food Bank. On March 8th, 23 students, together with faculty advisor Lindsay Davis, AzPA CEO Kelly Ridgway, and Fry’s Clinical Care Coordinator Whitney Rice, hosted a community health fair at the Glendale Adult Center. Students provided blood glucose, blood pressure, and cholesterol screenings to 56 patients, as well as educational materials and patient counseling on the topics of appropriate aspirin therapy, blood pressure control, blood glucose control, cholesterol management, and smoking cessation. Students from Midwestern also helped at first aid medical tents for the Tour de Cure cycling event in Phoenix on March 16th. Recently, the Student Pharmacist Academies at the University of Arizona and Midwestern University helped launch the statewide Women’s Preconception Health Campaign, “Power Me A to Z,” by hosting lunch meetings for pharmacy students. Over 100 students attended the meetings at each of the schools to learn about the importance of taking folic acid, the goals of the campaign, and how they could get involved. Sophia Galloway, SPA Co-Chair, Midwestern University College of Pharmacy Glendale sgalloway63@midwestern.edu Eric Wong, SPA Co-Chair, University of Arizona College of Pharmacy ewong@pharmacy.arizona.edu

Congratulations to the 2013 AzPA Student Leadership Program participants! Front row (left to right) Cassandra Anderson, Amanda Powell, Kate Van Hassel, Lara Petrossian, Hillary Aphaisuwan, Metta Lou Henderson, Ph.D., (speaker), Thu Nguyen, Asal Azizoddin, AzPA President Kelly Ridgway. Back row (left to right) Tom Jaeger, Pharm.D., (speaker); AzPA President Mike Dietrich, Pharm.D., Matt Aronson, Sophia Galloway, Michael Ivey, Jake Bradshaw, Eric Wong, Brian Barkow. Spring 2013 • Arizona Journal of Pharmacy • 29

Drug Information Question

Question: Should gabapentin enacarbil (Horizant®) be considered a first-line treatment for moderate-to-severe primary restless legs syndrome? by Benjamin Lai, Pharm.D. Candidate, and Stacy L. Haber, Pharm.D., Associate Professor, Midwestern University College of Pharmacy-Glendale

Answer: Introduction According to the National Institute of Neurological Disorders and Stroke, up to 10% of the U.S. population may have restless legs syndrome (RLS), and though most cases are mild, 2 to 3% suffer from cases that are moderate to severe.1 It is characterized by an irresistible urge to move the legs, usually accompanied by an unpleasant sensation often described as creeping, tugging, or pulling.2 Patients suffering from RLS often become restless at night, resulting in a loss of quality sleep. It can result from chronic kidney disease, iron deficiency, or pregnancy, and though the primary cause is largely unknown, mild dopaminergic hypofunction is thought to be involved.3,4 Pramipexole and ropinirole are dopamine agonists that are FDA-approved for the treatment of moderate-to-severe RLS and are considered first-line therapies, but they are associated with nausea, vomiting, fatigue, and augmentation (defined as a worsening of symptoms, an increase in symptom distribution, or an earlier onset of symptoms).3,5 Other options include sedative hypnotics to help sleep, but they do not treat RLS symptoms, and opiates for painful symptoms, but they have addictive properties.3 Gabapentin is useful in RLS, especially for painful symptoms, but its absorption is variable between patients, its bioavailability decreases with increasing dose, and it has a short half-life. These pharmacokinetic properties create problems in patients who require higher doses or longer and more consistent relief. As a result, gabapentin enacarbil (GEn), a prodrug formulation of gabapentin with more consistent absorption and extended-release properties, was developed.6 GEn was approved by the FDA in April of 2011 for moderateto-severe primary RLS.6 In a search of Medline, 5 randomized, double-blinded, placebo-controlled trials were found with a primary efficacy endpoint of International Restless Legs Syndrome (IRLS) and Clinical Global Impression-Improvement (CGI-I) scores.7-11 Three of the trials that were at least 12 weeks in duration will be summarized.7-9 Clinical Trials In clinical trials, the IRLS and CGI-I scale scores are used to evaluate symptoms.5,7-9 IRLS is a rating scale regarding the severity of patient symptoms over the past week. Patients answer 10 questions on a scale of 0 to 4, with a total score ranging from 0 (no symptoms) to 4 (severe symptoms). CGI-I scores identify to what extent a patient responds to treatment, with scores ranging from 1 (very much improved) to 7 (very much worse). Scores of 1 (very much improved) and 2 (much improved) are considered responders. In a trial by Kushida et al.,7 222 patients from 22 U.S. centers were randomized to receive GEn 1,200 mg (n = 114) or placebo (n = 108). Patients were instructed to take their regimen at 5:00 p.m. every night with food for 12 weeks. The co-primary endpoints were the change from baseline in IRLS score and investigator-rated CGI-I score. Other endpoints included the 30 • Arizona Journal of Pharmacy • Spring 2013

Pittsburgh Sleep Diary (PghSD), which assessed total sleep time (TST) and wake time after sleep onset (WASO), and the Medical Outcome Study (MOS) sleep scale, which assessed daytime somnolence, sleep quality, sleep adequacy, and sleep disturbance. Patients were given a diary to track onset times and severity of RLS symptoms daily. At week 1, the mean change from baseline IRLS score was greater with GEn compared to placebo (-10.7 vs. -4.4; p < 0.0001) and the percentage of patients rated by investigators as responders with the CGI-I scale was higher (57.9% vs. 24.8%; p < 0.0001). Similarly, at week 12, the change from baseline IRLS score was greater with GEn than placebo (-13.2 vs. -8.8; p < 0.0003) and the percentage of patients rated as responders was higher (76.1% vs. 38.9%; p < 0.0001). GEn increased the average daily TST at week 2 (difference 0.3 hours; p = 0.0033) and week 4 (difference 0.2 hours; p = 0.0246), but not at week 12 (difference 0.2 hours; p = 0.1870). The change in average daily WASO was greater with GEn (-17.6 minutes) than placebo (-11.8 min) at week 12. All MOS domains showed significantly more improvement with GEn than placebo in each category. The median time to onset of symptoms was 13.3 hours with GEn compared to 9.0 hours with placebo (p < 0.0006) at week 2 and > 23.5 hours with GEn compared to 11.5 hours with placebo (p < 0.0001) at week 12. Also at week 12, 50.5% of patients on GEn were symptom-free at 24 hours compared with 17.7% of patients on placebo. The most common adverse events reported in the GEn group were somnolence (26.5%) and dizziness (19.5%); most occurred within the first 2 weeks of treatment, but later remitted. This study concluded that GEn is generally well tolerated and significantly improved RLS symptoms and sleep outcomes. In a more recent trial by Lee et al.,8 325 patients from 28 research centers in the U.S. were randomized to receive GEn 1,200 mg (n = 113), 600 mg (n = 115), or placebo (n = 97). The design and methods were similar to the previous study, but a 600-mg dose was also evaluated. At the end of week 12, the majority of patients in the GEn groups (55.0% and 64.9% in the 1,200 mg and 600 mg groups, respectively) had an IRLS score ≤ 10 compared to the placebo group (32.3%). Of these patients, 22.5%, 26.3%, and 11.5% from the 1,200 mg, 600 mg, and placebo groups, respectively, had an IRLS score of 0, indicating symptom remission. Also at the end of week 12, a significantly greater proportion of the GEn groups (77.5% and 72.8% in the 1,200 mg and 600 mg groups, respectively) were deemed responders based on investigator-rated CGI-I scores than placebo (44.8%; p <0.0001). The sleep assessment results for GEn were similar to the trial by Kushida et al.7 when comparing 1,200 mg to placebo. For the 600-mg group compared to placebo, no significant differences were observed in TST and WASO; for the MOS, significant improvement was observed in sleep disturbance, sleep quality, and sleep adequacy, but not in daytime somnolence. When assessing onset of symptoms, 52.2% of GEn 1,200 mg and 49.5% of GEn 600 mg patients reported

Drug Information Question (continued from page 30) no symptoms from 8:00 p.m. to midnight compared to 36.5% of placebo patients; 37.0% of GEn 1,200 mg and 35.3% of GEn 600 mg patients reported no symptoms within the 24-hour period compared to 23.0% of placebo patients. The most common side effects were dizziness (24.3% and 10.4% for GEn 1,200 mg and 600 mg, respectively) and somnolence (18.0% and 21.7%, respectively). One patient in the GEn 1,200 mg group reported 8 events of sudden onset of sleep, but they resolved without intervention. This study concluded that both GEn 1,200 mg and 600 mg significantly improved RLS symptoms and sleep disturbances compared to placebo after 12 weeks, and both were generally well tolerated. The long-term safety and efficacy of GEn was tested in a trial by Bogan et al.9 This study had 2 phases. All patients received GEn 1,200 mg for 24 weeks in the first, single-blinded (SB) phase. Of those 311 patients, 194 who were responders were then randomized to receive GEn 1,200 mg (n = 96) or placebo (n = 98) for 12 weeks in the second, double-blinded (DB) phase. The primary endpoint was the proportion of patients who relapsed during the DB phase. Relapse was defined as withdrawal due to lack of efficacy or worsening of RLS symptoms (an increase of 6 points on the IRLS score from the baseline of the DB phase to ≥ 15 points and an investigator-rated Clinical Global Impression of Change rating of “much worse” or “very much worse” on 2 consecutive clinic visits at least 1 week apart). At the end of the DB phase, 9% of GEn patients had experienced a relapse compared to 23% of placebo patients (p = 0.02), and 54% GEn patients were symptom-free compared to 38% of placebo patients. The most common side effects for GEn were somnolence (29.8%) and dizziness (22.1%) in the SB phase and headache (4%) in the DB phase. One patient in the GEn group experienced convulsions (2 generalized seizures within 7 hours that occurred and resolved during the 1-week taper period following the DB phase), which were considered possibly treatment-related. The authors concluded that GEn’s safety and efficacy is maintained for up to 9 months of treatment. Discussion The data from all 3 studies support the use of GEn for moderate-to-severe primary RLS based on decreased IRLS scores, improved CGI-I ratings, and better sleep outcomes; however, some limitations were noted.7-9 Although studied in doses of 600 and 1,200 mg, only 600 mg was approved by the FDA because no additional benefit and a higher risk of adverse effects was observed at 1,200 mg.6 In the trial by Lee et al.,8 the 600-mg dose did not significantly improve some of the secondary endpoints (WASO, daytime somnolence, and TST); however, power was not met, which may have contributed to the lack of significance. In 2 of the trials, improvements in TST for GEn 1,200 mg were observed at weeks 2 and 4, but not at week 12, which may indicate a decrease in benefit as treatment progresses.7,8 Lastly, the trial by Kushida et al.7 involved patients with secondary RLS; the impact of this population is unclear, but the results were similar to other trials. The efficacy data for GEn were comparable to that of dopamine agonists. In a trial involving pramipexole, significant improvement was shown compared to placebo at week 6 in IRLS (-12.3 vs. -5.7) and CGI-I (62.9% vs. 32.5%).12 In a trial involving ropinirole, significant improvement was shown compared to placebo at week 12 for IRLS (-11.2 vs. -8.7) and

CGI-I (59.5% vs. 39.6%).13 Many patients discontinue dopamine agonists because of intolerable adverse effects, augmentation, or lack of response. In these cases, gabapentin and GEn are viable options, which have similar efficacy, no risk of augmentation, and an added benefit to those with painful symptoms. Gabapentin is less expensive since it is available as a generic; however, it may require twice daily dosing in more severe cases. GEn is taken once daily and is a good option for those with adherence issues. In summary, dopamine agonists should remain the firstline treatments for patients with RLS; GEn is a good second-line option for patients who fail dopamine agonists or may benefit from its effects on pain. References 1. National Institute of Neurological Disorders and Stroke. Restless legs syndrome fact sheet. www.ninds.nih.gov/disorders/restless_legs/detail_restless_ legs.htm (accessed Aug 29, 2012). 2. Restless Legs Syndrome Foundation. What is RLS? www.rls.org/page. aspx?pid=477 (accessed Aug 29, 2012). 3. Dopp JM. Sleep disorders. In: DiPiro JT, Talbert RL, Yee GC et al., eds. Pharmacotherapy: a pathophysiologic approach. 8th ed. New York: McGrawHill; 2011 (accessed Aug 29, 2012). 4. Sanders-Bush E, Hazelwood L. 5-hydroxytryptamine (serotonin) and dopamine. In: Chabner BA, Brunton LL, Knollman BC, eds. Goodman and Gilman’s the pharmacological basis of therapeutics. 12nd ed. New York: McGraw-Hill; 2011 (accessed Aug 29, 2012). 5. Hayes WJ, Lemon MD, Farver DK. Gabapentin enacarbil for treatment of restless legs syndrome in adults. Ann Pharmacother. 2012; 46(2):229-39. 6. Horizant (gabapentin enacarbil) package insert. Triangle Research Park, NC: GlaxoSmithKline; 2012. 7. Kushida CA, Becker PM, Ellenbogen AL et al. Randomized, double-blind, placebo-controlled study of XP13512/GSK1838262 in patients with RLS. Neurology. 2009; 72(5):439-46. 8. Lee DO, Ziman RB, Perkins AT et al. A randomized, double-blind, placebocontrolled study to assess the efficacy and tolerability of gabapentin enacarbil in subjects with restless legs syndrome. J Clin Sleep Med. 2011; 7(3):282-92C. 9. Bogan RK, Cramer Bornemann MA, Kushida CA et al. Long-term maintenance of restless legs syndrome with gabapentin enacarbil: a randomized controlled study. Mayo Clin Proc. 2010; 85(6):512-21. 10. Kushida CA, Walters AS, Becker P et al. A randomized, double-blind, placebo-controlled, crossover study of XP13512/GSK1838262 in the treatment of patients with primary restless legs syndrome. Sleep. 2009; 32(2):159-68. 11. Walters AS, Ondo WG, Kushida CA et al. Gabapentin enacarbil in restless legs syndrome: a phase 2b, 2-week, randomized, double-blind, placebo-controlled trial. Clin Neuropharmacol. 2009; 32(6):311-20. 12. Oetel WH, Stiasny-Kolster K, Bergtholdt B et al. Efficacy of pramipexole in restless legs syndrome: a six-week, multicenter, randomized, double-blind study (effect-RLS study). Mov Disord. 2007; 22(2):213-9. 13. Walters AS, Ondo WG, Dreykluft T et al. Ropinirole is effective in the treatment of restless legs syndrome. TREAT RLS 2: a 12-week, double-blind, randomized, parallel-group, placebo-controlled study. Mov Disord. 2004; 19(12):1414-23.

Arizona Center for Professional Education

brought to you by the Arizona Pharmacy Association Your online source for continuing pharmacy education, skills enhancement, and professional development. Visit www.azpharmacy.org Spring 2013 • Arizona Journal of Pharmacy • 31

Continuing Education

The Arizona Continuous Quality Assurance Law: How to Make Sure You and Your Pharmacy are in Compliance

Patrick Campbell, Pharm.D. Candidate Class of 2014, University of Arizona College of Pharmacy; Kristina Gerboth, Pharm.D. Candidate Class of 2014, University of Arizona College of Pharmacy; Terri L. Warholak, R.Ph., Ph.D., Assistant Professor, University of Arizona College of Pharmacy; Neil J. MacKinnon, BSc(Pharm), MSc(Pharm), Ph.D., Professor and Director of the Center for Rural Health, Mel and Enid Zuckerman College of Public Health, University of Arizona; Kenneth R. Baker, R.Ph., J.D., Of Counsel/ Pharmacy Consultant, Renaud Cook Drury Mesaros, PA Goal: This home-study CPE activity has been developed to educate pharmacists on the Arizona Continuous Quality Assurance Law. Objectives: At the conclusion of this lesson, successful participants should be able to: 1. Describe the rationale for the CQA legislation 2. List the important provisions of the CQA legislation 3. Describe changes that will need to be made to comply with the CQA legislation 4. Describe the impact of CQA in pharmacy practice and patient health 5. List strategies to overcome barriers to compliance with the CQA legislation 6. List resources to assist with CQA Why do we need a Continuous Quality Assurance (CQA) Law? In their landmark report titled “Crossing the Quality Chasm: A New Health System for the 21st Century,” the Institute of Medicine stated that “health care has safety and quality problems because it relies on outmoded systems of work. Poor designs set the workforce up to fail, regardless of how hard they try.”1 What does this mean for pharmacy? There is abundant amount of evidence showcasing the negative impact quality related events have on the United States (US) medication use system. Here are just a few examples: • Research suggests that for every $1.00 spent on a prescription costs more than $1.33 in drug-related illness and complications.2 • 1.5 million Americans are injured from medication errors yearly.3 • Medication errors can cost as much as $15 billion per year, accounting for approximately 7,000 deaths and over 770,000 injuries.4 • Almost five percent of all hospitalizations can be attributed to

medication errors.5 In fact, some have suggested that if looked at objectively, health care is among the most dangerous of all industries.6 Is being careful “good enough”? Let’s find out. Complete the calculation in Figure 1 on page 33. After completing the calculation, one can see that being careful is not good enough – one must employ CQA techniques to prevent medication errors. In fact, the Institute of Medicine has indicated that “all health professionals should be educated to deliver … quality improvement approaches.”7 Defining Quality and CQA First, let’s answer the question- “What is health care quality?” Health care quality can be thought of as a combination of definitions.8 One definition is “the degree to which health services increase the probability of desired outcomes and reduce the probability of undesired outcomes.”9 Alternatively, healthcare quality can be thought of as “a quality health service/system [that]gives patients what they want and need.”10 There are several different methods to improve quality, but most quality improvement approaches have similarities; they: • Are continuous– one is never done improving quality; • Are patient centered—the focus is on providing the best quality care for the patient; • Are measured—one needs to be able to measure quality if one intends to improve it; • Include statistical process control— statistics play an important role in helping to realize if we really are improving the quality of care and remember that even percents and rates count as statistics; • Are system-wide—in order to offer the highest quality care to the patient, one must consider if changes in one

32 • Arizona Journal of Pharmacy • Spring 2013

•

portion of the system may have a negative impact in others; and Use a systems view — if one person has made an error, it is almost certain that someone else will make the exact same mistake *The most effective way to prevent error repetition is to change the system, not to blame the person*

How does one select a problem to focus on? A good way to start is to look for problems that will give you be biggest impact, such as: 1) high-risk processes, 2) high-volume processes, 3) problem-prone processes, and 4) high-cost processes. If a pharmacy is using a non-punitive error or near miss (i.e., an error that did not make it to the patient) reporting process, then one will know what these “big impact” areas are. This will provide evidence-based data to help with decisionmaking. The CQA process Note: While a detailed coverage of the quality improvement process is beyond the scope of this article, there are many articles and continuing education programs that cover the process in detail (including the EPIQ program available from the authors for free – the process will be covered in a full day continuing education program in June - see end of article). 1. Think about the methods that others have used in the past to solve similar QI problems and adapt them for your needs and practice situation. Examine the literature to see what has worked in similar situations. 2. Select the best intervention to accomplish your goal. 3. List process and/or outcome measures necessary to determine if global goal(s) was/were met. 4. Determine what data are already being collected and what measures exist.

Continuing Education (continued from page 32)

Figure 1: Dispensing error calculation worksheet Will dispensing errors impact YOU? Find out by completing the calculations below.

Dispensing Errors

Question:

1. How many prescriptions does your practice site fill daily? ________Rx/Day 2. Assume during an 8 hour shift you will fill 1/3 of these So divide Rx/Day by 3 = ________ Your Rx/Day Assumptions: 1. You will work 5 days a week. 2. You will work as a pharmacist for 20 to 40 years. Choose a number in between. 3. The dispensing error rate at your place of business is EXTREMELY LOW – use 1% as an estimate. If you know it is higher – use that number. Use these numbers to complete the following calculations: Your Rx/Day

Days/Week

Weeks/Year

Years of Work

Error %

Dispensing errors during your career

Rate x

Now, assume that 1% of the errors are of a serious nature – will cause harm. Write that number here ____________________.

Reflection Think about the numbers you calculated. How will dispensing errors affect you? ______________________________________________________________________ ______________________________________________________________________ ______________________________________________________________________

Spring 2013 • Arizona Journal of Pharmacy • 33

Continuing Education (continued from page 33) 5. Plan data collection methods. 6. Plan the statistical analysis making sure you will collect all information needed. 7. Break the project down into steps and detail practical considerations. Establish what Steps are needed, and determine the Who, What, Where, When, How each will be accomplished. 8. Sketch the preliminary timeline for project. 9. List any challenges to be addressed before the next meeting, and assign a responsible party to address each challenge listed above. Arizona CQA Laws and Regulations In 2012 the Arizona Board of Pharmacy approved regulations requiring community pharmacies to implement a continuous quality assurance (CQA) program whereby each pharmacy would adopt a planned process to reduce medication errors. The requirements of the state’s CQA program are set forth in Arizona statue A.R.S. §32-1973 and Board of Pharmacy regulations R4-23-110 and R423-620. In short, each pharmacy’s CQA program must be designed to identify, evaluate, and prevent medication errors. By doing so, Arizona has joined a growing number of states requiring pharmacies to have systems that can reduce the risk of medication errors. While the state requires that pharmacies must have CQA systems, Arizona leaves the design of the programs up to the individual pharmacy. In some states, these systems are referred to as continuous quality improvement or CQI or, as in Arizona, continuous quality assurance or CQA. These efforts represent pharmacy’s commitment to the profession’s foremost duty – “First, do no harm.” Under Arizona law, a medication error is defined as “any unintended variation from a prescription or medication order.” Specifically, this definition does not include what is commonly referred to as a near-miss – a medication mistake “that is corrected before the medication is dispensed to the patient or patient’s caregiver.” In most sections of the regulations the pharmacy and the pharmacist-incharge (PIC) share the responsibilities for implementing the programs and seeing that they work. This includes

requirements that the pharmacy’s staff be trained and that the training, rules, policies and procedures of the program are all documented. These records must be kept a minimum of two years.11 Policies and Procedures Not only must the staff be trained, the pharmacist in charge (PIC) and pharmacy must also see that all members of the staff including all pharmacists and technicians comply with the pharmacy’s CQA policies and procedures. The policies and procedures may be written or in electronic form but must be reviewed at least every 2 years and revised if necessary. Such reviews must be documented. Not only must the policies and procedures be available for board inspectors, they must also be accessible for all employees of the pharmacy.11 Record, Measure, and Analyze Medication Error Data Most experts in pharmacy quality systems agree that in order for a CQA/ CQI program to be effective, it must be designed to continuously improve. This requires a pharmacy to collect information on each error. Moreover, a program is most effective if, in addition to collecting data on each error that reaches a patient, all near-misses, mistakes that were prevented from reaching a patient, should also be recorded. There was considerable discussion by the Arizona Board of Pharmacy concerning this point. In the end, the Board decided that each pharmacy could make the decision of whether it would record just errors or errors plus near-misses when designing and implementing its CQA program. The final Arizona regulations require only that the pharmacy and PIC “record, measure, and analyze data collected to assess the causes and any contributing factors relating to medication errors.” The regulations specify that the purpose of the data is to “improve the quality of patient care . . . and to prevent or reduce medication errors.”11 Periodically, (at least annually) the pharmacy and PIC must communicate its CQA findings to pharmacy staff. In addition, when any changes are made to the program, the CQA processes or the policies and procedures, pharmacy personnel must be informed. Arizona regulations are unique in that they, by specific language, limit the

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board’s right to review collected data. The board can look at the pharmacy’s CQA policies and procedures and it can enforce the CQA rules and statutes, but it cannot analyze the data itself. This still leaves room for the board to determine if required information is collected, used and analyzed. It can also check to see if training was adequate and if all required documentation has been recorded. Should the board find, when evaluating a medication error, that the pharmacy is in compliance with the law of CQA, the board must consider that fact “as a mitigating factor” in its investigation.11 The Quality Assurance in Community Pharmacy Experience in Nova Scotia, Canada It is hard to get much further away from Arizona on the continent of North America than Nova Scotia, Canada, which is northeast of Maine, on the Atlantic Ocean. Still, pharmacists in Nova Scotia share something in common with pharmacists in Arizona: their pharmacy regulatory body recently required their community pharmacies to implement a quality assurance program. In 2010, the pharmacy regulatory body in that province, the Nova Scotia College of Pharmacists (NSCP), implemented new Standards of Practice called “Continuous Quality Assurance Programs in Community Pharmacy.”12 Per these standards, the quality assurance program must: 1. Monitor staff performance, equipment, facilities and adherence to standards of practice, 2. Manage known, alleged and suspected medication errors that reach the patient consistent with the best practices for this activity undertaken by others in the profession, 3. Enable and require anonymous reporting of quality related events (QREs) to an independent, objective third party organization for population of a national aggregate database from which learnings arising from trends and patterns can be communicated across the profession, 4. Encourage open dialogue on QREs between pharmacy staff and management through quarterly review of the pharmacy’s aggregate QRE data, 5. Document quality improvements made as a result of the quarterly CQI

Continuing Education (continued from page 34) meetings of staff, 6. Require completion of a medication safety self-assessment annually, and monitoring the progress of the resulting enhancement plan at quarterly CQI meetings, 7. Include provisions to protect the confidentiality of information relating to specific patients, and 8. Achieve the purposes of an effective CQI program through ongoing education of pharmacy staff on the current best practices in QRE management and adoption of these practices. It is worth noting that while the legislation in Nova Scotia and Arizona are similar, there are also some important differences. For example, community pharmacies in Arizona are not required to: 1. Report near misses 2. Hold quarterly staff meetings to discuss errors and near misses 3. Report errors to an independent third party 4. Conduct annual self-assessments of safety Researchers from Dalhousie University and St. Francis Xavier University, in partnership with the NSCP, launched a program called SafetyNET-Rx to help pharmacists meet this regulatory requirement and to implement an effective quality assurance program.13 The objective of SafetyNET-Rx is to implement demonstrated best practices for patient safety in community practice. SafetyNETRx aims to accomplish this by assisting pharmacists through training programs, website content, on-site pharmacy visits, newsletters, the development of “howto” manuals, and financial incentives. SafetyNET-Rx also provides training to the NSCP pharmacy inspectors (compliance officers) and aniPad-based assessment tool was developed for these individuals to use during their pharmacy visits. SafetyNET-Rx began as a pilot in July 2008 with a mix of 13 different types of pharmacies and in April 2010 it expanded to 70 community pharmacies. Due to a wait-list of pharmacies wanting to participate in SafetyNET-Rx, the program again expanded to 79 pharmacies. A rigorous evaluation plan was included as part of SafetyNET-Rx to carefully evaluate the impact of the program using both quantitative and qualitative methods. While the program is still in progress

at the time of writing this article, there are some preliminary results which are encouraging for those who believe in the value of quality assurance programs in community pharmacy. The community pharmacies who participated in the SafetyNET-Rx program completed a medication safety selfassessment tool prior to implementation of their quality assurance program and after one year of implementation and they believe that the safety of their pharmacies improved. More specifically, there were statistically significant improvement in the self-assessed safety of patient information, drug information, communication of drug orders, drug labeling and packaging, drug standardization and distribution, staff competence and education, and quality processes and risk management.14 There are several lessons Arizona pharmacists can learn from their colleagues in Nova Scotia who have been dealing with the implementation of quality assurance programs over the past 2-3 years. First, when surveyed, community pharmacists in Nova Scotia who had implemented such programs said the best two ways to improve the reporting of medication errors are sharing with colleagues the lessons learned from errors and assuring anonymity for pharmacists and pharmacy technicians.15 Second, the chain pharmacies which were most successful at implementing quality assurance programs shared a strong belief that their head/corporate office had a genuine interest in these activities.16 Third, while computerized reporting of medication errors is superior to manual processes, regardless of the type of system used by a pharmacy, it should be cost effective, be easy to complete and involve low risk to the operations.17 Finally, critical factors related to reporting, and learning from, medication errors include the culture of the pharmacy, management support, the pharmacy regulatory body, among other things.18 CQA Is Easy and Rewarding: Real-World Examples Technician data entry and filling errors in an outpatient hospital pharmacy. As part of the Pharm.D. curriculum at the University of Arizona College of Pharmacy, second year pharmacy students participate in the Quality Improvement and Medication Error Reduction course, PhPr863a, taught by Dr. Terri Warholak.

As part of the course, groups of students are assigned to a specific preceptor and location. They design, implement, analyze and present the findings of a quality improvement project. One group wanted to determine what areas of improvement were needed in an outpatient hospital setting, so the team designed a project that investigated filling and data entry errors and surveyed technicians’ perceptions of error rates. Technicians were asked to rank error types based on how frequently they thought the errors occurred in the pharmacy using a scale from 1-9, with 1 being the most frequent and 9 being the least frequent. Pharmacists on site recorded error data during visual verification. If errors were found, the pharmacist would check a box corresponding to the error category (see Figure 2 on page 38). The data collection form was designed to limit the temporal burden of the pharmacist and was incorporated into the workflow appropriately. Data were collected for two weeks; a total of 4578 prescriptions and 162 errors were found. After the baseline data were collected, they were compared to the results of technician surveys. The most common data entry errors in the preintervention period were wrong directions (53, 1.16% of total prescriptions) and wrong day supply (38, 0.83% of total prescriptions). These errors were the focus of the intervention. The educational intervention reflected a team meeting where technicians were shown data results, provided with information from Pharmacy Technician’s Letter, and brainstormed ideas on how to reduce error rate since it was found that the technicians correctly identified the two most common errors. A graphic was also placed on input terminals during the post-intervention period to reinforce the two most common error types. Data were collected again for a two week post-invention period. There were a total of 4625 prescriptions and 122 errors during the post-intervention time period. The difference in days’ supply errors as a percentage of total prescriptions was statistically significant when analyzed using a Chi Square test with Yates correction factor (C2=5.906, p<0.05) while the difference in wrong sig errors was not statistically significant (see Figure 3 on page 39). It was also found that

Spring 2013 • Arizona Journal of Pharmacy • 35

Continuing Education (continued from page 35) the overall rate of errors was statistically significant when analyzed using a Chi Square test with Yates correction factor for a 2x2 table (C2=5.945, p<0.05) (see Figure 4 on page 39). Overall this project demonstrates that the quality improvement process is easy to implement, it is important to open channels of communication between pharmacy staff members, and utilizing resources readily available can make an important impact on error rate.19 Medication reconciliation and hospital readmission rates Another group of students looked into the impact of a medication reconciliation program on hospital readmission rates. The medication reconciliations were performed by pharmacists employed by the University of Arizona Health Plans and the population was the Special Needs Population (SNP) insured by both Medicare and the Arizona Health Care Cost Containment System (AHCCCS). Data were collected from a database containing information on hospital admissions and two time periods were compared; before the medication reconciliation program was implemented and after the program was implemented. Date of admission and discharge and ICD-9 diagnosis codes were used to track hospital admissions. During the pre-intervention data collection phase, there were 94 hospital admissions, 3 of which were patient readmissions under the same diagnosis code. In the post-intervention data collection phase, there were 207 hospital admissions, 1 of which was a patient readmission under the same diagnosis code. Though the result was not statistically significant (p = 0.17), it does show an absolute reduction in the proportion of hospital admissions that were readmissions under the same diagnosis code (see Figure 5 on page 39).20 Overall, this project demonstrates that even a small quality improvement project done by Pharm.D. students can show an organization how their new program is performing and help them decide where to target for future quality improvement programs. There are resources to assist YOU with CQA Pharmacy Quality Commitment (PQC™) is a continuous quality

improvement program that helps you comply with quality assurance requirements found in network contracts, Medicare Part D, and state regulations. Part of the Alliance for Patient Medication Safety, which is a federally listed patient safety organization, PQC™ offers strong federal protection and confidentiality for your patient safety data and quality improvement work. PQC is an “off the shelf” CQA program that helps: • Establish a quality-conscious workflow • Encourage adoption of a fair and positive-based safety culture • Identify, collect, and report Quality Related Events (medication errors that reach the patient and “near misses” and unsafe conditions) • Analyze your QREs to identify process improvement opportunities • Improve workflow to decrease harmful QREs PQC is brought to you by your State Pharmacy Association. (http://www.pqc. net)2 Institute for Safe Medication Practices (ISMP) (http://www.ismp.org) offers a wealth of information for pharmacists from error reporting to the confused drug name list. The RISK ASSESSMENT FOR MEDICATION SAFETY for community pharmacies is particularly useful for identifying problems within a community pharmacy. The Risk document is designed to help community pharmacies take a process-driven, systembased approach to address this critical issue (http://www.ismp.org/communityRx/ aroc/) Also, the community pharmacy newsletter is worth subscribing to as it brings vital and potentially life-saving information about medication-related errors, adverse drug reactions, as well as recommendations that will help reduce the risk of medication errors and other adverse drug events in your community practice site. In addition to the newsletter, ISMP sends urgent advisories about serious errors or information that requires immediate attention to its subscribers. (http://www.ismp.org/newsletters/ ambulatory/default.asp) The Pharmacy Quality Alliance (PQA) (http://www.pqaalliance.org) PQA is a collaborative initiative of organizations and stakeholders committed to improving pharmacist care.3 Members represent most major pharmacy

36 • Arizona Journal of Pharmacy • Spring 2013

professional associations, major health care providers, and payers. PQA’s interest is twofold: (1) develop and implement strategies to measure performance at the pharmacy and pharmacist level and (2) report meaningful information to patients, pharmacists, employers, health insurance plans, and other health care decision makers to aid them in making informed choices and to stimulate development of new payment models. PQA has developed performance measures for medication adherence, patient satisfaction, diabetes care, and asthma treatment. It has also developed reporting templates for pharmacists and patients. PQA has developed Medication Measures Included in the Part D Plan Ratings such as: 1) the percentage of older adults (>65yo) who receive a medication that is considered to put the patient at high-risk for an adverse drug-related event; 2) patients who have received a medication for diabetes as well as any drug that could be used for treatment of hypertension; and 3) the percentage of patients taking medications in a particular drug class that have high adherence (PDC > 80% for the individual). These star and other PQA developed metrics are worth watching and measuring in pharmacies because they are being used as measures of pharmacy quality and may be used for coverage decisions, in-network decisions, and pay for performance. Educating Pharmacists and Pharmacy Students to Improve Quality (EPIQ) The purpose of EPIQ is to teach student pharmacists, pharmacists, and other stakeholders about measuring, reporting, and improving quality in pharmacy practice. EPIQ educational materials are available from Warholak@pharmacy. arizona.edu at no charge as part of a grant from PQA. Several articles have been written about EPIQ effectiveness and content.21,22,23,24 References 1. Kohn LT, Corrigan JM, Donaldson MS, eds. Crossing the Quality Chasm: A New Health System for the 21st Century. Institute of Medicine Committee on Quality of Health Care in America. Washington DC: National Academy Press; 2001.Sage Publications;2001 (Executive Summary. pp1-23.) 2. Harrison DL, Bootman JL, Cox ER.Costeffectivess of consultant pharmacists in managing drug-related morbidity and mortality in nursing facilities. Am J Health-Syst Pharm. 1998;55(15):1588-94. 3. Committee on Identifying and Preventing Medication Errors. (2007). Preventing Medication Errors: Quality Chasm Series: The National

Continuing Education (continued from page 36) Academies Press. 4. Committee on Quality of Health Care in America, Institute Of Medicine. (2001). Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academy of Sciences Press. 5. Velo, Giampaolo P., and PietroMinuz. “Medication Errors: Prescribing Faults and Prescription Errors.” Br J ClinPharmacol. 67.6 (2009): 624-28. 6. AmalbertiR, Auroy Y, Berwick D, et al. Five system barriers to achieving ultrasafe health care. Ann Intern Med. 2005;142:756-64. Greiner AC, Knebel E. Health professions education: a bridge to quality. Washington, DC: National Academies Press; 2003:3. 7. IOM 2003 Greiner, AC, Knebel E. Committee on the Health Professions Education Summit. Health Professions Education: A Bridge to Quality. Washington, DC: National Academies Press, 2003: 190. 8. Warholak TL.Ensuring quality in pharmacy operations. In: Desselle S and Zgarrick D, eds. Pharmacy Management. 2nd ed. New York:McGraw Hill; 2008:125-149. 9. Lohr KN. Health, health care, and quality of care. In: Lohr KN, ed. Medicare: A Strategy for Quality Assurance. Washington DC: National Academy Press, 1990, p. 19. 10. Ovretveit J. Health Service Quality. Oxford, England: Blackwell Scientific, 1992. 11. Arizona State Board of Pharmacy.Article 6.Permits and Distribution of Drugs.R4-23-620.Continuous Quality Assurance Program.Retrieved at: http:// www.azpharmacy.gov/rules_and_statutes/pdfs/ ContinuousQualityAsssuranceProgramRules12-02-2012.pdf. Accessed 2012 Dec 31. 12. Nova Scotia College of Pharmacists. Standards of Practice: Continuous Quality Assurance Programs in Community Pharmacy. 2010 Retrieved at: http:// www.nspharmacists.ca/standards/documents/ QualityAssurance.pdf. Accessed 2012 Dec 31. 13. SafetyNET-Rx. [homepage on the Internet]. Retrieved at:http://www.safetynetrx.ca/. Accessed 2012 Dec 31. 14. Boyle TA, Ho C, MacKinnon NJ, et al. Safety Implications of Standardized Continuous Quality Improvement Programs in Community Pharmacy.J Pharm Pract. 2012; doi: 10.1177/0897190012452312. 15. Scobie AC, Boyle TA, MacKinnon NJ, Deal H, Mahaffey T. Perceptions of community pharmacy staff regarding strategies to reduce and to improve the reporting of medication incidents.Can Pharm J (Ott).2010;143:296-301. 16. Scobie AC, Boyle TA, MacKinnon NJ, Mahaffey T. Head office commitment to quality-related event reporting in community pharmacy. Can Pharm J (Ott).2012; 145(3):e1-e6. 17. Boyle TA, Scobie AC, MacKinnon NJ, Mahaffey T. Quality-related event learning in community pharmacies: Manual versus computerized reporting process. J Am Pharm Assoc. 2012; 52(4): 498-506. 18. Boyle TA, Mahaffey T, MacKinnon NJ, Deal H, Hallstrom LK, Morgan H. Determinants of medication incident reporting, recovery, and learning in community pharmacies: A conceptual model. Res SocialAdm Pharm. 2011; 7(1): 93-107. 19. Campbell P, Klein M, Summy C, Thoi S. Technician data entry and filling errors in an outpatient hospital setting. Poster session presented at: The University of Arizona College of Pharmacy Quality Improvement Poster Session; May 2012, Tucson, AZ. 20. Gerboth K, Hayes J, Jasensky A, Poist J, Francis

W. The benefit of medication reconciliation on hospital readmission rates.Poster session presented at: The University of Arizona College of Pharmacy Quality Improvement Poster Session; May 2012, Tucson, AZ. 21. Jackson TL.Application of quality assurance principles: Teaching students medication error reduction skills in a “real world” environment. Am J Pharm Educ.2004; 68(1) Article 17. 22. Warholak TL, Noureldin M, West D, HoldfordD. Faculty perceptions of the Educating Pharmacy Students to Improve Quality (EPIQ) program.Am J Pharm Educ2011; 75 (8) Article 163. PMID: 22102753 23. Gilligan A, Myers J, Nash J, LavigneJ, Moczygemba L, Plake K, Quinones-Boex A, Holdford D, West D, Warholak TL. Educating Pharmacy Students to Improve Quality (EPIQ) in colleges and schools of pharmacy.Am J Pharm Educ.2012;76(6):Article 109. 24. Warholak TL, West D, Holdford D.The Educating Pharmacy Students and Pharmacists to Improve Quality program: tool for pharmacy practice.J Am Pharm Assoc.2010;50:534-538. PMID: 2062187

Discipline by the Board may be the result of egregious or repeated non-compliance by both permit holders and/licensees at any time.

Editor’s note: • A full-day CQA continuing education session at the June 27-30, 2013, in Tucson at the Westin La Paloma. • Students to help you with your CQA projects – see real-world examples contact Dr. Warholak at Warholak@pharmacy.arizona.edu • Assistance to a limited number of pharmacies contact Dr. MacKinnon neilmackinnon@email.arizona.edu

Starting in April 2013 researchers from the University of Arizona will collect information about how to assist YOU and YOUR PHARMACY become compliant with this new CQA requirement. The information will be used to design a continuing pharmacy education program on medication errors to be presented at the Arizona Pharmacy Association Annual Convention in June 2013.

Faculty Disclosures: Kenneth Baker, R.Ph., J.D. is a consultant of Pharmacists Mutual Insurance Companies. All other authors of this CPE activity have no actual or potential financial affiliation with any corporate organization.

Please contact Terri Warholak, Ph.D., R.Ph. at 520-626-4240 or warholak@pharmacy.arizona.edu to participate in this survey. Participation is completely voluntary and no personal identifiable information will be collected.

This article is an adaptation of a live continuing education presentation titled “The New Arizona Community Pharmacy Continuous Quality Assurance (CQA) Legislation” (APCE UAN 0100-0000-12053-L03) that was originally presented in Phoenix, Arizona at the Arizona Pharmacy Association Community Practice Academy Conference on September 22, 2012. CPE MONITOR INSTRUCTIONS:

CQA SURVEY PARTICIPANTS WANTED!

Effective January 1, 2014, the Arizona State Board of Pharmacy will begin actively enforcing the new continuous quality assurance requirements for community pharmacies to record all medication errors.

An additional continuing pharmacy education homestudy article titled Updates in the Management of Stable Chronic Obstructive Pulmonary Disease is available on the AzPA website in the AJP Archives. Member login is required.

Beginning January 1, 2013 Statements of Credit for home-study activities will no longer be provided. All activities will be reported to the NABP CPE Monitor system as mandated by ACPE.

Free CPE credit from home study articles published in the Arizona Journal of Pharmacy is a member benefit for AzPA Members.

Licensees may obtain additional information and set up their NABP e-Profile at www.MyCPEmonitor.net.

Not a member? Visit the AzPA website and join today! Spring 2013 • Arizona Journal of Pharmacy • 37

Continuing Education (continued from page 37) Figure 2: Data collection form utilized by pharmacists during visual verification

38 â€˘ Arizona Journal of Pharmacy â€˘ Spring 2013

Continuing Education (continued from page 38) Figure 3: Graph comparing the frequency of errors before and after the technician education intervention took place

The difference in day supply errors as a percentage of total prescriptions was statistically significant (Χ2=5.906, p<0.05). Figure 4: Table containing total errors, total prescriptions and percentage of total prescriptions before and after the technician education intervention took place Total errors Total prescriptions % of total prescriptions Pre-intervention 162 4578 3.54 Post-intervention 122 4625 2.64 The change in total error rate was statistically significant when analyzed using a Chi Square test with Yates correction factor for a 2x2 table (Χ2=5.945, p<0.05). Figure 5: Comparison of hospital readmissions with same diagnosis within 15 days of discharge before and after the medication reconciliation program was in place

Readmitted with same diagnosis Readmission within 15 days of discharge for date range November 2009 - January 2010 Readmission within 15 days of discharge for date range November 2011 - January 2012

Not readmitted with Total same diagnosis

206

207

297

301

Comparison of remittance for the same diagnosis pre and post was not statistically significant (p = 0.17) Spring 2013 • Arizona Journal of Pharmacy • 39

Continuing Education Quiz The Arizona Continuous Quality Assurance Law: How to Make Sure You and Your Pharmacy Are in Compliance 1. The chain pharmacies in Nova Scotia, Canada, which were most successful at implementing quality assurance programs: a. Shared a strong belief that their head/ corporate office had a genuine interest in these activities b. Were located in rural communities c. Had high prescription volumes d. Completed an annual assessment of the safety of their pharmacies 2. Which of the following was NOT one of critical factors related to reporting, and learning from, medication errors in pharmacies in Nova Scotia, Canada? a. The culture of the pharmacy b. Management support c. The pharmacy regulatory body d. The pharmacist-to-prescription count ratio 3. Which of the following best describes the rationale behind the Arizona CQA Legislation? a. To establish a positive safety culture in pharmacies b. To burden pharmacists with another regulatory procedure c. To encourage pharmacists to analyze errors and to make improvements d. a and c e. All of the above

4. Which provisions are included as part of Az CQA? a. The pharmacy manager must be the pharmacist to conduct CQA meetings in pharmacies b. Pharmacists are exclusively responsible for CQA documentation c. Pharmacies not in compliance with the Arizona CQA Program by October 2013 will be fined d. None of the above e. All of the above 5. Actions required for implementation and compliance? a. Establish CQA record keeping b. Train ALL pharmacy staff on CQA measures c. Facilitate and document CQA meetings d. a and c e. All of the above 6. Which is an example of how CQA can impact the profession? a. Encourage a fair and positive safety culture b. Establish a quality-conscious workflow c. Reduce medication errors and near misses d. Improve patient care e. All of the above

7. Which strategies can be utilized to overcome barriers? a. Educate pharmacy staff about the new legislation b. Utilize CQA resources c. Incorporate CQA measures into pharmacy workflow d. None of the above e. All of the above 8. Which can be a resource for information pertaining to CQA? a. National Committee for Quality Assurance (NCQA) b. Agency for Healthcare Research and Quality (AHRQ) c. Institute for Safe Medication Practices (ISMP) d. a and c e. All of the above 9. Only government agencies are reliable resources. a. True b. False

This activity was developed by the Arizona Pharmacy Association for pharmacists as a knowledgebased learning activity. The Arizona Pharmacy Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

The Arizona Continuous Quality Assurance Law: How to Make Sure You and Your Pharmacy Are in Compliance ACPE UAN#0100-0000-13-017-H03-P This activity is accredited for 1.0 hours of CPE credit (CEUs 0.10) This activity is a benefit to AzPA members. Non-members of AzPA must enclose a $25.00 check payable to the Arizona Pharmacy Association. In order to qualify for ACPE credit, participants must achieve a grade of 70% or above on the quiz and submit a completed activity evaluation. ACTIVITY EVALUATION – Please indicate if the activity met the stated learning objectives: 1. Describe the rationale for the CQA legislation 2. List the important provisions of the CQA legislation 3. Describe changes that will need to be made to comply with CQA legislation 4. Describe the impact of CQA in pharmacy practice and patient health 5. List strategies to overcome barriers and resources to assist with CQA

AGREE AGREE AGREE AGREE AGREE

DISAGREE DISAGREE. DISAGREE DISAGREE DISAGREE

Will the information presented cause you to make any changes to your style or method? Yes No If you answered “yes” please list one or two things you will do differently: _________________________________________________________________________________________________________________________________ _________________________________________________________________________________________________________________________________ Overall evaluation of the article content: (please circle one)

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Activity accredited date: 04-15-2013 Expiration date: 04-15-2016. Name __________________________________________________________ Send this page to: AzPA, 1845 E. Southern Ave., Tempe, AZ 85282 Address ________________________________________________________

Email ________________________________________________________

City, State, Zip ___________________________________________________ Birthdate (MM/DD only) ______________ NABP e-Profile ID# ________________

40 • Arizona Journal of Pharmacy • Spring 2013

2012 Recipients of the “Bowl of Hygeia” Award

John Harmon Alabama

Lyle Fibranz Alaska

Hal Wand Arizona

Donald L. Hedden Arkansas

Melvin K. Renge, Jr California

Jeannine Dickerhofe Colorado

Paul Limberis Colorado*

Scott Wolak Connecticut

Kimberly Couch Delaware

Angela D. Adams Florida

William Moye Georgia

Kelly S.M. Go Hawaii

Randy Malan Illinois

Gerald Roesener Indiana

Eugene Lutz Iowa

Marvin E. Bredehoft Kansas

George Hammons Kentucky

Roxie Stewart Louisiana

Joe Bruno Maine

Frank Nice Maryland

Edward S. Radock Massachusetts

Gregory Baise Michigan

Larry Leske Minnesota

Waymon Tigrett Mississippi

Matt Hartwig Missouri

Jim Seifert Montana

Edward M. DeSimone, II Nebraska

Joe Kellogg Nevada

George Bowersox New Hampshire

Frank Breve New Jersey

Kenneth Corazza New Mexico

Nasir Mahmood New York

Beverly Lingerfeldt North Carolina

Dennis DelaBarre North Dakota

Mimi Hart Ohio

John Foust Oklahoma

Marcus Watt Oregon

Richard Smiga Pennsylvania

Santa E. Nieves Puerto Rico

Michael Simeone Rhode Island

Julian Reynolds South Carolina

Galen Jordre South Dakota

Marion Crowell Tennessee

Dennis Song Texas

Lloyd J. Thomas Utah

Empsy Munden Virginia

Michelle Valentine Washington

Eric Belldina West Virginia

Gary Bongey Wisconsin

Tonya Woods Wyoming

The “Bowl of Hygeia”

The Bowl of Hygeia award program was originally developed by the A. H. Robins Company to recognize pharmacists across the nation for outstanding service to their communities. Selected through their respective professional pharmacy associations, each of these dedicated individuals has made uniquely personal contributions to a strong, healthy community. We offer our congratulations and thanks for their high example. The American Pharmacists Association Foundation, the National Alliance of State Pharmacy Associations and the state pharmacy associations have assumed responsibility for continuing this prestigious recognition program. All former recipients are encouraged to maintain their linkage to the Bowl of Hygeia by emailing current contact information to awards@naspa.us. The Bowl of Hygeia is on display in the APhA Awards Gallery located in Washington, DC. Boehringer Ingelheim is proud to be the Premier Supporter of the 2012 & 2013 Bowl of Hygeia program. *2011 recipient awarded in 2012

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