Report of the Academy Presidents: Leading key initiatives as part of APhA's strategic plan

ASSOCIATION REPORT

Report of the Academy Presidents: Leading key initiatives as part of APhA’s strategic plan

members—with the tools, resources, and connections necessary to become engaged and make a difference in the future of our profession.

APhA–APPM Nicki Hilliard APhA–APRS William E. Fassett APhA–ASP Brandi A. Hamilton

Engaging pharmacists across pharmacy practice In keeping aligned with the current needs and practice trends of the profession, APhA has created a member-friendly structure for the APhA–APPM Academy through which members can be engaged, interact, lead, and actively participate in activities of their Association and the profession. Starting at the 2012 APhA Annual Meeting, we began transitioning from the original APhA–APPM section structure established more than 100 years ago. We have since effectively implemented a new structure based on Special Interest Groups (SIGs), which afford pharmacists an opportunity to network and engage on a grassroots level based on the practice interests of individual members. The Association hosts e-Community discussion boards and allows resources to be posted for SIG members to ask ques-

APhA–APPM As I reflect upon my first year as President of APhA–APPM, I am impressed with the level of engagement of our members and the significant growth of the Academy throughout the year. With the launch of several new Special Interest Groups (SIGs) for Academy members this year, the AcadHilliard emy has in just 2 short years successfully implemented a structure by which more of our members can interact and engage in the work of the Association and the pharmacy profession. As we face the ever-changing needs of our health care system, I can assure you through the leadership and planning process that the Academy consistently focused work and efforts in 2013–14 on the charges handed down by APhA President Steven Simenson—assisting in transforming the role of the pharmacist, employing ways of empowering members, participating in advocating for the profession, and working to develop leaders. The result is significant progress in advancing the profession, based upon the hard work and tireless efforts of you, our members, working hand in glove with the elected leaders of APhA–APPM and the staff of our Association. We have accomplished a lot, but we still have a tremendous amount of work to do.

102 JAPhA | 5 4 :2 | M AR/AP R 2014

Practice and the future of the profession As our health care system continues to evolve in the wake of health care reform and implementation of the Affordable Care Act, pharmacy is changing. With APhA playing a major role, the profession has undertaken the ambitious effort of achieving provider status for pharmacists, with the members of APhA–APPM at the forefront of these efforts. As health care professionals, we will share their patient care stories, advocate to elected leaders at the federal and state level, and explore new models at the federal, state, and private-payer level for access and coverage of pharmacists’ patient care services. It is our role as APhA–APPM to provide you—our practitioner

The Association Report column in JAPhA reports on activities of APhA’s three academies and topics of interest to members of those groups. The APhA Academy of Pharmacy Practice and Management (APhA–APPM) is dedicated to assisting members in enhancing the profession of pharmacy, improving medication use, and advancing patient care. Through the APhA-APPM Special Interest Groups (SIGs), the Academy provides members a mechanism to network and support the profession by addressing emerging issues. To access a listing of APhA-APPM SIGs, visit www.pharmacist. com. The mission of the APhA Academy of Pharmaceutical Research and Science (APhA– APRS) is to stimulate the discovery, dissemination, and application of research to improve patient health. Academy members are a source of authoritative information on key scientific issues and work to advance the pharmaceutical sciences and improve the quality of pharmacy practice. Through the three APhA–APRS sections (Clinical Sciences, Basic Pharmaceutical Sciences, and Economic, Social, and Administrative Sciences), the Academy provides a mechanism for experts in all areas of the pharmaceutical sciences to influence APhA’s policymaking process. The mission of the APhA Academy of Student Pharmacists (APhA–ASP) is to be the collective voice of student pharmacists, to provide opportunities for professional growth, and to envision and actively promote the future of pharmacy. Since 1969, APhA–ASP and its predecessor organizations have played a key role in helping students navigate pharmacy school, explore careers in pharmacy, and connect with others in the profession. The Association Report column is written by Academy and section officers and coordinated by JAPhA Executive Editor L. Michael Posey of the APhA staff. Suggestions for future content may be sent to [email protected].

ja p h a .org

Journal of the American Pharmacists Association

Amneal Pharmaceuticals has Important News for Pharmacists INTRODUCING

Esomeprazole therapy at an easy-to-swallow price Esomeprazole, one of the top-selling therapies in the US,1 is now available as Esomeprazole Strontium delayed-release capsules 49.3 mg. This strontium salt is a pharmaceutical alternative with the same indication in adults as Nexium® (esomeprazole magnesium) delayed-release capsules; it is not approved for patients under 18 years old. Esomeprazole Strontium provides the same dose of esomeprazole therapy as Nexium® 40 mg at a potentially more attractive cost.

NEW

ESOMEPRAZOLE STRONTIUM Learn more at esomep.com

Indications and Usage Esomeprazole Strontium is a proton pump inhibitor (PPI) indicated for adults for: Treatment of gastroesophageal reflux disease (GERD) Risk reduction of NSAID-associated gastric ulcer H. pylori eradication to reduce the risk of duodenal ulcer recurrence Pathological hypersecretory conditions, including Zollinger-Ellison syndrome The safety and effectiveness of esomeprazole strontium have not been established in pediatric patients. Esomeprazole strontium is not recommended for use in pediatric patients. The safety of esomeprazole strontium has not been studied in patients with severe renal impairment. Esomeprazole strontium is not recommended for use in patients with severe renal impairment. Nursing mothers should consider discontinuing esomeprazole strontium. There are no studies in pregnant women. Esomeprazole Strontium should be used during pregnancy only if the potential benefits justify the potential risk to the fetus. Important Safety Information Esomeprazole strontium is contraindicated in patients with known hypersensitivity to PPIs. Hypersensitivity reactions, e.g., angioedema and anaphylactic shock have been reported with esomeprazole use. Symptomatic response to therapy does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in biopsies from patients treated long-term with omeprazole. PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea. ● ● ● ●

Avoid concomitant use of esomeprazole strontium with clopidogrel, because the metabolism of clopidogrel can be impaired. When using esomeprazole strontium consider alternative anti-platelet therapy. Long-term and multiple daily dose PPI therapy may be associated with an increased risk of osteoporosis-related fractures of the hip, wrist, or spine. Hypomagnesemia has been reported rarely with prolonged treatment with PPIs. Serious events included tetany, arrhythmias, and seizures, and may require discontinuation of the PPI. Most common adverse reactions in adults (≥18 years) (incidence ≥1%) are headache, diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth. Avoid concomitant use of esomeprazole strontium with drugs which induce CYP2C19 or CYP3A4, such as with St. John’s Wort or rifampin, due to the potential substantial reduction in esomeprazole levels. Patients treated with PPIs and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time. Esomeprazole may interfere with the absorption of drugs for which gastric pH affects bioavailability (e.g., ketoconazole, iron salts, and digoxin). Drug-induced decreases in gastric acidity may increase serum chromogranin A (CgA) levels and may cause false positive results in diagnostic investigations for neuroendocrine tumors. Providers should temporarily stop esomeprazole treatment before assessing CgA levels. Concomitant use with atazanavir and nelfinavir is not recommended; Concomitant use of saquinavir with PPIs is expected to increase saquinavir concentrations, which may increase toxicity.

Please see the Brief Summary of the full Prescribing Information on the next page.

Reference: 1. Top 100 Drugs for Q3 2013 by Sales. Drug Information Online. November, 2013. Available at: http://www.drugs.com/stats/top100/sales?printable=1. Accessed 11/06/2013. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. All trademarks are property of their respective owners. Products are not to scale and color may vary. ©2014 Amneal Pharmaceuticals LLC. All rights reserved. ESPA-0114bPH Journal of the American Pharmacists Association

j apha.org

MAR /APR 2014 | 54:2 |

JAPhA 103

BRIEF SUMMARY

ESOMEPRAZOLE STRONTIUM delayed-release capsules 49.3 mg For oral use only Rx Only BRIEF SUMMARY of Prescribing Information INDICATIONS AND USAGE Treatment of GERD in Adults: Esomeprazole strontium is indicated for the short-term treatment (4 to 8 weeks) for healing and symptomatic resolution and maintenance (controlled studies do not extend beyond 6 months) of confirmed erosive esophagitis (EE), the short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults. Risk Reduction of NSAID-Associated Gastric Ulcer in Adults, H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in Adults, and Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome in Adults. CONTRAINDICATIONS Esomeprazole strontium is contraindicated in patients with known hypersensitivity to proton pump inhibitors (PPIs). Hypersensitivity reactions, e.g., angioedema and anaphylactic shock, have been reported with esomeprazole use. For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with esomeprazole strontium, refer to the CONTRAINDICATIONS section of their package inserts. WARNINGS AND PRECAUTIONS Concurrent Gastric Malignancy: Symptomatic response to therapy with esomeprazole strontium does not preclude the presence of gastric malignancy. Atrophic Gastritis: Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole, of which esomeprazole is an enantiomer. Clostridium difficile Associated Diarrhea: Published observational studies suggest that PPI therapy like esomeprazole strontium may be associated with an increased risk of Clostridium difficile associated diarrhea. This diagnosis should be considered for diarrhea that does not improve. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents. For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with esomeprazole strontium, refer to WARNINGS and PRECAUTIONS sections of those package inserts. Interaction with Clopidogrel: Avoid concomitant use of esomeprazole strontium with clopidogrel. Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is entirely due to an active metabolite. The metabolism of clopidogrel to its active metabolite can be impaired by use with concomitant medications, such as esomeprazole, that inhibit CYP2C19 activity. Concomitant use of clopidogrel with 40 mg esomeprazole reduces the pharmacological activity of clopidogrel. When using esomeprazole strontium, consider alternative anti-platelet therapy. Bone Fracture: Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines. Hypomagnesemia: Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI. For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically. Concomitant Use of esomeprazole strontium with St. John’s Wort or Rifampin: Drugs which induce CYP2C19 or CYP3A4 (such as St. John’s Wort or rifampin) can substantially decrease esomeprazole concentrations. Avoid concomitant use of esomeprazole strontium with St. John’s Wort or rifampin. Interactions with Diagnostic Investigations for Neuroendocrine Tumors: Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors. Providers should temporarily stop esomeprazole treatment before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g., for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary. Concomitant Use of esomeprazole strontium with Methotrexate: Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/ or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration a temporary withdrawal of the PPI may be considered in some patients.

104 JAPhA | 5 4 :2 | M AR/AP R 2014

ja p h a .org

ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of esomeprazole strontium has been established from adequate and wellcontrolled studies of esomeprazole magnesium. Adults: The safety of esomeprazole magnesium was evaluated in over 15,000 patients (aged 18 to 84 years) in clinical trials worldwide including over 8,500 patients in the United States and over 6,500 patients in Europe and Canada. Over 2,900 patients were treated in long-term studies for up to 6-12 months. In general, esomeprazole magnesium was well tolerated in both short and long-term clinical trials. The safety in the treatment of healing of erosive esophagitis was assessed in 4 randomized comparative clinical trials, which included 1,240 patients on 22.3 mg of esomeprazole magnesium (equivalent to 20 mg of esomeprazole), 2,434 patients on 44.6 mg of esomeprazole magnesium (equivalent to 40 mg of esomeprazole), and 3,008 patients on 20 mg of omeprazole daily. The most frequently occurring adverse reactions (≥1%) in all three groups were headache (5.5%, 5%, and 3.8%, respectively) and diarrhea (no difference among the three groups). Nausea, flatulence, abdominal pain, constipation, and dry mouth occurred at similar rates among patients taking esomeprazole magnesium or omeprazole. Additional adverse reactions that were reported as possibly or probably related to esomeprazole magnesium with an incidence <1% are listed below by body system: Body as a Whole: abdomen enlarged, allergic reaction, asthenia, back pain, chest pain, substernal chest pain, facial edema, peripheral edema, hot flushes, fatigue, fever, flu-like disorder, generalized edema, leg edema, malaise, pain, rigors; Cardiovascular: flushing, hypertension, tachycardia; Endocrine: goiter; Gastrointestinal: bowel irregularity, constipation aggravated, dyspepsia, dysphagia, dysplasia GI, epigastric pain, eructation, esophageal disorder, frequent stools, gastroenteritis, GI hemorrhage, GI symptoms not otherwise specified, hiccup, melena, mouth disorder, pharynx disorder, rectal disorder, serum gastrin increased, tongue disorder, tongue edema, ulcerative stomatitis, vomiting; Hearing: earache, tinnitus; Hematologic: anemia, anemia hypochromic, cervical lymphadenopathy, epistaxis, leukocytosis, leukopenia, thrombocytopenia; Hepatic: bilirubinemia, hepatic function abnormal, SGOT increased, SGPT increased; Metabolic/ Nutritional: glycosuria, hyperuricemia, hyponatremia, increased alkaline phosphatase, thirst, vitamin B12 deficiency, weight increase, weight decrease; Musculoskeletal: arthralgia, arthritis aggravated, arthropathy, cramps, fibromyalgia syndrome, hernia, polymyalgia rheumatica; Nervous System/Psychiatric: anorexia, apathy, appetite increased, confusion, depression aggravated, dizziness, hypertonia, nervousness, hypoesthesia, impotence, insomnia, migraine, migraine aggravated, paresthesia, sleep disorder, somnolence, tremor, vertigo, visual field defect; Reproductive: dysmenorrhea, menstrual disorder, vaginitis; Respiratory: asthma aggravated, coughing, dyspnea, larynx edema, pharyngitis, rhinitis, sinusitis; Skin/Appendages: acne, angioedema, dermatitis, pruritus, pruritus ani, rash, rash erythematous, rash maculo-papular, skin inflammation, sweating increased, urticaria; Special Senses: otitis media, parosmia, taste loss, taste perversion; Urogenital: abnormal urine, albuminuria, cystitis, dysuria, fungal infection, hematuria, micturition frequency, moniliasis, genital moniliasis, polyuria; Visual: conjunctivitis, vision abnormal. Endoscopic findings that were reported as adverse reactions include: duodenitis, esophagitis, esophageal stricture, esophageal ulceration, esophageal varices, gastric ulcer, gastritis, hernia, benign polyps or nodules, Barrett’s esophagus, and mucosal discoloration. In two placebo-controlled studies, 710 patients were treated symptomatic GERD and the most common adverse reactions possibly or probably related to esomeprazole magnesium were diarrhea (4.3%), headache (3.8%), and abdominal pain (3.8%). Combination Treatment with Amoxicillin and Clarithromycin: In clinical trials using combination therapy with esomeprazole magnesium plus amoxicillin and clarithromycin, no additional adverse reactions specific to these drug combinations were observed. Adverse reactions that occurred were limited to those observed when using esomeprazole magnesium, amoxicillin, or clarithromycin alone. The most frequently reported drug-related adverse reactions for patients who received triple therapy for 10 days were diarrhea (9.2%), taste perversion (6.6%), and abdominal pain (3.7%). No treatment-emergent adverse reactions were observed at higher rates with triple therapy than were observed with esomeprazole magnesium alone. For more information on adverse reactions with amoxicillin or clarithromycin, see their package inserts, refer to ADVERSE REACTIONS sections. Postmarketing Experience The following adverse reactions have been identified during post-approval use of esomeprazole magnesium. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reports are listed below by body system: Blood and Lymphatic: agranulocytosis, pancytopenia; Eye: blurred vision; Gastrointestinal: pancreatitis, stomatitis, microscopic colitis; Hepatobiliary: hepatic failure, hepatitis with or without jaundice; Immune System: anaphylactic reaction/ shock; Infections and Infestations: GI candidiasis; Clostridium difficile associated diarrhea; Metabolism and nutritional disorders: hypomagnesemia; Musculoskeletal and Connective Tissue: muscular weakness, myalgia, bone fracture; Nervous System: hepatic encephalopathy, taste disturbance; Psychiatric: aggression, agitation, depression, hallucination; Renal and Urinary: interstitial nephritis; Reproductive System and Breast: gynecomastia; Respiratory, Thoracic, and Mediastinal: bronchospasm; Skin and Subcutaneous Tissue: alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal). Journal of the American Pharmacists Association

DRUG INTERACTIONS Interference with Antiretroviral Therapy: Concomitant use of atazanavir and nelfinavir with PPIs is not recommended. Coadministration of atazanavir with PPIs is expected to substantially decrease atazanavir plasma concentrations and may result in a loss of therapeutic effect and the development of drug resistance. Coadministration of saquinavir with PPIs is expected to increase saquinavir concentrations, which may increase toxicity and require dose reduction. Omeprazole, of which esomeprazole is an enantiomer, has been reported to interact with some antiretroviral drugs. The clinical importance and the mechanisms behind these interactions are not always known. Increased gastric pH during omeprazole treatment may change the absorption of the antiretroviral drug. Other possible interaction mechanisms are via CYP2C19. Reduced concentrations of atazanavir and nelfinavir: For some antiretroviral drugs, such as atazanavir and nelfinavir, decreased serum levels have been reported when given together with omeprazole. Following multiple doses of nelfinavir (1250 mg, twice daily) and omeprazole (40 mg daily), AUC was decreased by 36% and 92%, Cmax by 37% and 89% and Cmin by 39% and 75%, respectively for nelfinavir and M8. Following multiple doses of atazanavir (400 mg, daily) and omeprazole (40 mg, daily, 2 hr before atazanavir), AUC was decreased by 94%, Cmax by 96%, and Cmin by 95%. Concomitant administration with omeprazole and drugs such as atazanavir and nelfinavir is therefore not recommended. Increased concentrations of saquinavir: For other antiretroviral drugs, such as saquinavir, elevated serum levels have been reported, with an increase in AUC by 82%, in Cmax by 75%, and in Cmin by 106%, following multiple dosing of saquinavir/ritonavir (1000/100 mg) twice daily for 15 days with omeprazole 40 mg daily coadministered days 11 to 15. Clinical and laboratory monitoring for saquinavir toxicity is recommended during concurrent use with esomeprazole. Dose reduction of saquinavir should be considered from the safety perspective for individual patients. Drugs for Which Gastric pH Can Affect Bioavailability: Esomeprazole inhibits gastric acid secretion. Therefore, esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g. ketoconazole, atazanavir, iron salts, and erlotinib can decrease, while the absorption of drugs such as digoxin can increase during treatment with esomeprazole. Concomitant treatment with omeprazole (20 mg daily) and digoxin in healthy subjects increased the bioavailability of digoxin by 10% (30% in two subjects). Esomeprazole is an enantiomer of omeprazole. Coadministration of digoxin with esomeprazole is expected to increase the systemic exposure of digoxin. Patients may need to be monitored when digoxin is taken concomitantly with esomeprazole. Effects on Hepatic Metabolism/Cytochrome P-450 Pathways: Esomeprazole is extensively metabolized in the liver by CYP2C19 and CYP3A4. In vitro and in vivo studies have shown that esomeprazole is not likely to inhibit CYPs 1A2, 2A6, 2C9, 2D6, 2E1, and 3A4. No clinically relevant interactions with drugs metabolized by these CYP enzymes would be expected. Drug interaction studies have shown that esomeprazole does not have any clinically significant interactions with phenytoin, quinidine, clarithromycin, or amoxicillin. Although drug interaction studies have not shown that esomeprazole has a clinically significant interaction with warfarin, post-marketing reports of changes in prothrombin measures have been received among patients on concomitant warfarin and esomeprazole therapy. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with PPIs and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time. Esomeprazole may potentially interfere with CYP2C19, the major esomeprazole metabolizing enzyme. Coadministration of esomeprazole 30 mg and diazepam, a CYP2C19 substrate, resulted in a 45% decrease in clearance of diazepam. Clopidogrel is metabolized to its active metabolite in part by CYP2C19. Concomitant use of esomeprazole 40 mg results in reduced plasma concentrations of the active metabolite of clopidogrel and a reduction in platelet inhibition. Avoid concomitant administration of esomeprazole strontium with clopidogrel. When using esomeprazole strontium, consider use of alternative anti-platelet therapy. Omeprazole acts as an inhibitor of CYP2C19. Omeprazole, given in doses of 40 mg daily for one week to 20 healthy subjects in a cross-over study, increased Cmax and AUC of cilostazol by 18% and 26% respectively. Cmax and AUC of one of its active metabolites, 3,4-dihydrocilostazol, which has 4-7 times the activity of cilostazol, were increased by 29% and 69% respectively. Coadministration of cilostazol with esomeprazole is expected to increase concentrations of cilostazol and its above mentioned active metabolite. A dose reduction of cilostazol from 100 mg twice daily to 50 mg twice daily should be considered. Concomitant administration of esomeprazole and a combined inhibitor of CYP2C19 and CYP3A4, such as voriconazole, may result in more than doubling of the esomeprazole exposure. Dose adjustment of esomeprazole is not normally required. However, in patients with Zollinger-Ellison’s Syndrome, who may require higher doses up to 240 mg/day, dose adjustment may be considered. Drugs known to induce CYP2C19 or CYP3A4 or both (such as rifampin) may lead to decreased esomeprazole serum levels. Omeprazole, of which esomeprazole is an enantiomer, has been reported to interact with St. John’s Wort, an inducer of CYP3A4. In a cross-over study in 12 healthy male subjects, St. John’s Wort (300 mg three times daily for 14 days) significantly decreased the systemic exposure of omeprazole in CYP2C19 poor metabolisers (Cmax and AUC decreased by 37.5% and 37.9%, respectively) and extensive metabolisers (Cmax and AUC decreased by 49.6 % and 43.9%, respectively). Avoid concomitant use of St. John’s Wort or rifampin with esomeprazole strontium. Interactions with Investigations of Neuroendocrine Tumors: Drug-induced decrease in gastric acidity results in enterochromaffin-like cell hyperplasia and increased Chromogranin A levels, which may interfere with investigations for neuroendocrine tumors. Tacrolimus: Concomitant administration of esomeprazole and tacrolimus may increase the serum levels of tacrolimus. Combination Therapy with Clarithromycin: Coadministration of esomeprazole, clarithromycin, and amoxicillin has resulted in increases in the plasma levels of Journal of the American Pharmacists Association

esomeprazole and 14-hydroxyclarithromycin. Concomitant administration of clarithromycin with other drugs can lead to serious adverse reactions due to drug interactions [see WARNINGS and PRECAUTIONS in prescribing information for clarithromycin]. Because of these drug interactions, clarithromycin is contraindicated for coadministration with certain drugs [see CONTRAINDICATIONS in prescribing information for clarithromycin]. Methotrexate: Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate. However, no formal drug interaction studies of methotrexate with PPIs have been conducted. SPECIFIC POPULATIONS Pregnancy: Pregnancy Category C: There are no adequate and well controlled studies of esomeprazole strontium delayed-release capsules in pregnant women. Teratogenicity was not observed in an embryofetal developmental study in rats with either esomeprazole strontium or esomeprazole magnesium at equimolar oral doses up to 280 mg esomeprazole/kg/day (about 57 times the daily maximum recommended human dose (MRHD) of 40 mg on a body surface area basis). When administered as either the strontium or magnesium salt, changes in bone morphology and physeal dysplasia were observed in pre- and postnatal developmental toxicity studies in rats at doses equal to or greater than 138 mg esomeprazole/kg/day (approximately 33.6 times the daily MRHD of 40 mg on a body surface area basis). Because of the observed effect at the high doses of esomeprazole strontium on developing bone in rat studies, esomeprazole strontium should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers: Limited published data indicate that esomeprazole and strontium are present in human milk. Because of the effect of esomeprazole strontium observed at high doses on developing bone in rat studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use: The safety and effectiveness of esomeprazole strontium delayed-release capsules have not been established in pediatric patients. Strontium is known to compete with calcium for intestinal absorption and is incorporated into bone. Use in pediatric patients is not recommended because adequate safety studies have not been performed. Geriatric Use: No overall differences in safety and efficacy were observed between the elderly and younger individuals, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Use in Patients with Renal Impairment: No dosage adjustment is necessary in patients with mild to moderate renal impairment. The pharmacokinetics and safety of strontium in patients with severe renal impairment has not been studied and, therefore, use in this patient population is not recommended. OVERDOSAGE A single oral dose of esomeprazole at 510 mg/kg (about 103 times the human dose on a body surface area basis), was lethal to rats. The major signs of acute toxicity were reduced motor activity, changes in respiratory frequency, tremor, ataxia, and intermittent clonic convulsions. The symptoms described in connection with deliberate esomeprazole overdose (limited experience of doses in excess of 240 mg/day) are transient. Single doses of 80 mg of esomeprazole were uneventful. Reports of overdosage with omeprazole in humans may also be relevant. Doses ranged up to 2,400 mg (120 times the usual recommended clinical dose). Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen in normal clinical experience (see omeprazole package insert - ADVERSE REACTIONS). No specific antidote for esomeprazole is known. Since esomeprazole is extensively protein bound, it is not expected to be removed by dialysis. In the event of overdosage, treatment should be symptomatic and supportive. As with the management of any overdose, the possibility of multiple drug ingestion should be considered. For current information on treatment of any drug overdose contact a Poison Control Center at 1-800-222-1222. Please see package insert for full prescribing information. More detailed information is available upon request. For more information about esomeprazole strontium contact: Amneal Pharmaceuticals at 1-877-835-5472. Date of Issue: December 2013 Licensed from: Hanmi Pharm. Co. Ltd., Seoul, Korea Distributed by: Amneal Pharmaceuticals, Glasgow, KY 42141

© Amneal Pharmaceuticals LLC. All rights reserved. ESPA-0114bPH j apha.org

MAR /APR 2014 | 54:2 |

JAPhA 105

ASSOCIATION REPORT

tions, receive information, and discuss topics related to their special interests. The leadership of each SIG is composed of a Coordinator, Coordinator-elect, and committees. Each SIG also provides members with the opportunity to work together on topics and areas of interest. Additionally, to ensure communications between the APhA–APPM Executive Committee and SIG leaders, an Executive Committee Officer is appointed as a liaison to each SIG. Pharmacists and student pharmacist members are able to join as many SIGs as they desire. Joining a SIG is easy! Just visit the Academy’s webpage at www.pharmacist.com/ APhA–APPM to sign up. Leadership Executive Committee. The 2013–14 APhA–APPM Executive Committee comprised a strong leadership team of nine members, including myself, Andrew Bzowyckyj, Kansas City, MO; Collin Conway, Tukwila, WA; Michael Hogue, Mount Olive, AL; Holly Hurley, Tyler, TX; Carrie Koenigsfeld, Johnston, IA; Amy Lugo, Keystone Heights, FL; Sarah Ray, Milwaukee, WI; and Eric Smith, Madison, WI. The Executive Committee routinely met to track progress toward Academy goals. On a quarterly basis, SIG leaders and the New Practitioner Advisory Committee Chair were included on Executive Committee meetings. Academy leaders also attended and participated in several APhA–Academy of Student Pharmacists Midyear Regional Meetings in fall 2013 to promote Academy involvement to our new colleagues. Standing Committees. Through the APhA–APPM Standing Committees, the Academy supports APhA’s awards, communication, education, and policy programs and initiatives. Committee members include APhA–APPM Officers and Academy volunteers. APhA–APPM Awards Standing Committee. The APhA–APPM 106 JAPhA | 5 4 :2 | M AR/AP R 2014

Awards Standing Committee is responsible for administering a comprehensive awards program that recognizes the outstanding contributions of pharmacists from diverse practice settings. The Awards Committee serves to review processes and recommend improvements for the APhA Awards Program. The Committee was also responsible for selecting the following award recipients for recognition at APhA2014: ❚❚ Daniel B. Smith Practice Excellence Award: Allen Nichol, PharmD ❚❚ APhA–APPM Pharmacy Management Excellence Award: Timothy J. Stroup, BSPharm, FAPhA, FASHP ❚❚ APhA–APPM Distinguished Achievement Awards­ : Pharmacy Management—John O. Beckner, BSPharm; Pharmacy Practice—Stuart J. Beatty, PharmD, BCPS, CDE; Service—Kristin Weitzel, PharmD, CDE, FAPhA; William H. Briner Distinguished Achievement Award in Nuclear Pharmacy Practice— Jeffrey P. Norenberg, MS, PharmD, PhD, BCNP, FASHP, FAPhA; Distinguished New Practitioner Award: Brent N. Reed, PharmD, BCPS ❚❚ APhA fellows selected by APhA–APPM: Amber L. Briggs, PharmD, BC-ADM, CGP, BCPS, FASCP; Daniel E. Buffington, PharmD, MBA; Lou Diorio, BSPharm; Jeff Goad, PharmD, MPH; Melissa Somma McGivney, PharmD, FCCP; Michael Pavlovich, PharmD; Jennifer L. Rodis, PharmD, BCPS; Norman P. Tomaka, BSPharm, MS; Adam C. Welch, PharmD, MBA, BCACP; Pamela A. Whitmire, PharmD, MHSA APhA–APPM Communications Standing Committee. The Communications Standing Committee is tasked with evaluating and formulating recommendations for effective communication with Association members. As part of its work in 2013, the Committee recommended changes to improve the layout of ja p h a .org

Academy and SIG content areas on pharmacist.com. Additionally, the Committee assisted the Association in identifying methods to increase awareness of and member participation in the new and improved APhA MTM Map, developed SIG branding, and contemplated ways to use social media to promote Academy activities and SIG interests. APhA–APPM Education Standing Committee. The Education Standing Committee is tasked with contributing to APhA Annual Meeting educational programming, assisting APhA staff in identifying APhA Contributed Papers Program abstract reviewers and poster judges, and creating a process for conducting Academy-related webinars. This past year, the Committee created three new guidance documents to assist SIGs in conducting webinars. For APhA2014, the Committee provided significant input on educational programming and identified content to be presented at the new Patient Care Services Pearls session. In coordinating the APhA2014 Contributed Papers Program, the Committee received 392 poster submissions in 2013. During APhA2014, the Academy judges will select a total of eight APhA–APPM Presentation Merit Award winners in the following categories: APhA–APPM Contributed Research Papers (practitioner and student pharmacist), Innovative Practice Reports (practitioner and student pharmacist), and Current Residents Reports on Projects in Progress. The names of APhA–APPM 2014 Merit Award winners will be published in the July/August 2014 issue of this Journal. APhA–APPM Policy Standing Committee. The Policy Standing Committee is tasked with reviewing current APhA policy and policy adopted by the APhA House of Delegates, as well as proposing new policy as appropriate. The Committee also encourages Academy leaders and members to become Advocacy Key Contacts and contribute to the APhA Political Action Committee;

Journal of the American Pharmacists Association

ASSOCIATION REPORT

APhA–APPM’s Special Interest Groups Compounding SIG Coordinator, Carol Petersen, BSPharm, CNP Coordinator-elect, Lou Diorio, BSPharm The Compounding SIG launched in August 2013 with the stated purpose of providing a professional network through which pharmacists can share ideas, education, and advocacy in compounding pharmacy. The Compounding SIG actively engaged with APhA Government Affairs staff in responding to the Food and Drug Administration’s proposed regulatory actions on implementation of the new compounding law. The Compounding SIG will hold its first meeting at APhA2014.

Diabetes Management SIG Coordinator, Jennifer D. Smith, PharmD, CPP, BC-ADM, CDE Coordinator-elect, Wendy Mobley-Bukstein, PharmD, CDE The Diabetes Management SIG launched in May 2013 with the stated purpose of sharing with pharmacists ideas and information related to the care of diabetes patients. In 2013, the members reviewed the National Diabetes Education Program brochure and collected pictures and stories celebrating American Pharmacists Month. The Diabetes Management SIG will hold its first meeting at APhA2014.

Immunizing Pharmacists SIG Coordinator, Adam Welch, PharmD, MBA, BCACP Coordinator-elect, Karl Hess, PharmD The Immunizing Pharmacists SIG launched in March 2013 with the stated purpose of providing members with leadership development and opportunities to engage in the recognition and policy, education, and awards processes important to immunizing pharmacists. This year, the SIG engaged in robust discussions of influenza vaccinations and the Centers for Disease Control and Prevention’s 2014 Yellow Book: Health Information for International Travel.

Medical Home/ACO SIG Coordinator, Bella Mehta, PharmD, FAPhA Coordinator-elect, Mary Ann Kliethermes, BS, PharmD The Medical Home/ACO (Accountable Care Organization) SIG launched in May 2013 with the stated purpose of sharing ideas among pharmacists involved in all aspects of delivering patientcentered pharmacy care in medical home and ACO models and those who would like to learn more about this emerging model of practice. SIG leaders participated in the APhA–APPM Medical Home Workgroup’s joint initiative with the Patient-Centered Primary Care Collaborative (PCPCC). The Medical Home/ACO SIG will host its first meeting at APhA2014.

Medication Management SIG Coordinator, Michael Schuh, BSPharm, PharmD, MBA Coordinator-elect, Carmela Avena-Woods, PharmD, CGP The Medication Management SIG launched in December 2011 with the stated purpose of providing an opportunity for pharmacists from different practice areas to communicate professional interests, concerns, and prospective goals for medication therapy management (MTM) services. The SIG created an extensive group resource area through its e-Community and hosted a webinar on provider status

Journal of the American Pharmacists Association

with active participation from more than 120 members. The webinar resulted in robust member interaction and dialogue on the successes and challenges related to MTM and provider status within the eCommunity.

Nuclear Pharmacy Practice SIG Coordinator, Fred Gattas, PharmD, BCNP Coordinator-elect, Mark Soffing, BS, PharmD, MS, MBA The Nuclear Pharmacy Practice SIG launched in December 2011 with the stated purpose of providing pharmacists involved in the specialty practice of nuclear pharmacy an avenue to fulfill individual professional goals and to support the goals of the Academy. Each month, the New Practitioner Committee Chair profiles one member, providing the opportunity for members to become more acquainted with each other and to share diverse opportunities in the field. The SIG is currently drafting an outsourcing guide applicable to nuclear pharmacy practice and has been very active with APhA Government Affairs staff regarding compounding legislation. The SIG is working toward endowment of the William H. Briner Distinguished Achievement Award in Nuclear Pharmacy Practice.

Pain, Palliative Care and Addiction SIG Coordinator, Charles Broussard, BSPharm, MEd, FAPhA Coordinator-elect, Jeffrey Baldwin, PharmD, FAPhA, FASHP The Pain, Palliative Care, and Addiction SIG launched in May 2012 with the stated purpose of supporting pharmacists who care for individuals with pain and pain-associated illnesses. The SIG also focuses on all types of addiction. The SIG assisted in the selection of this year’s recipients of the Ronald L. Williams Memorial Fund Scholarship. The SIG also helped draft new business to be introduced at the APhA2014 House of Delegates on “Controlled Substances and Other Medications with the Potential for Abuse.”

Preceptor SIG Coordinator, Karen Whalen, PharmD, BCPS, CDE Coordinator-elect, Susan Vos, PharmD, BSPharm, BCPS The Preceptor SIG launched in December 2011 as a professional network of pharmacists who share an interest in all aspects of precepting student pharmacists and pharmacy residents. In April 2013, the Preceptor SIG held a webinar, “Precepting Challenges: Tips for Preventing and Managing Difficult Learning Situations,” with more than 100 attendees. The SIG is currently developing this year’s webinar topic, which is tentatively scheduled for mid-2014, as well as reviewing the Accreditation Council for Pharmacy Education’s Draft Revised Standards for the Professional Program Leading to the Doctor of Pharmacy Degree.

Transitions of Care SIG Coordinator, Shelley Otsuka, PharmD, BCACP Coordinator-elect, Shanta Sen, PharmD, BCPS The Transitions of Care SIG launched in November 2013 with the stated purpose of sharing ideas among pharmacists and pharmacy technicians to optimize the care that patients receive during care transitions. The SIG allows interested members to make contributions to this emerging new practice expansion opportunity as pharmacists further establish themselves as recognized health care providers. The Transitions of Care SIG will hold its first meeting at APhA2014. j apha.org

MAR /APR 2014 | 54:2 |

JAPhA 107

ASSOCIATION REPORT

Compounding  

55  

165  

Diabetes  Management  

413    

Immunizing  Pharmacists  

109  

Medical  Home/ACO  

822  

Medica'on  Management    

219  

Nuclear  Pharmacy  Prac'ce  

Pain,  Pallia've  Care  &  Addic'on  

134  

 

Preceptor  

192  

 

Transi'ons  of  Care  

2,164  SIG  Par'cipants   55  

Figure 1. APhA–APPM Special Interest Groups and memberships, 2014

Abbreviations used: ACO, accountable care organizations; SIGs, Special Interest Groups

encourages communication with legislators; and promotes APhA advocacy-related resources and tools. The Committee reviewed and discussed APhA2013 referred policies pertaining to “’Take Home’ Naloxone for Prevention of Opioid Overdose Death and Controlled Substances and Other Medications with the Potential for Abuse.” As a result, the Committee created a New Business Item to be introduced into the APhA2014 House of Delegates. In addition to encouraging Academy leaders and members to become APhA Advocacy Key Contacts (as mentioned above), the Committee also assisted the Association with 108 JAPhA | 5 4 :2 | M AR/AP R 2014

provider status initiatives by seeking members who could share provider status stories. These are online in the Provider Status section of pharmacist.com. Four key initiatives In support of the APhA Strategic Plan, the APhA–APPM Academy focused on four key initiatives: establishing and expanding the Academy SIGs; increasing Academy member awareness of and engagement with the Association; facilitating member identification and referral; and developing and implementing the structure and function of Academy workgroups to foster ja p h a .org

member involvement in Association projects and initiatives. Establishing and expanding Academy SIGs. The SIGs currently in operation are Compounding; Diabetes Management; Immunizing Pharmacists; Medical Home/ACO; Medication Management; Nuclear Pharmacy Practice; Pain, Palliative Care, and Addiction; Preceptors; and Transitions of Care. Members have the option of joining more than one SIG. Figure 1 details membership within each of the nine individual SIGs. Details on the history, purpose, and leadership of the SIGs are shown in the sidebar on page 107.

Journal of the American Pharmacists Association

AS YOUR PATIENT’S DAY CHANGES, SO WILL THEIR IOP.

For your patients in need of a PGA,

LOWER IOP SUSTAIN IOP

1,2

Choose BAK-free TRAVATAN Z® Solution INDICATIONS AND USAGE TRAVATAN Z® (travoprost ophthalmic solution) 0.004% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Dosage and Administration The recommended dosage is 1 drop in the affected eye(s) once daily in the evening. TRAVATAN Z® Solution should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the IOP-lowering effect. TRAVATAN Z® Solution may be used concomitantly with other topical ophthalmic drug products to lower IOP. If more than 1 topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes apart. IMPORTANT SAFETY INFORMATION Warnings and Precautions Pigmentation —Travoprost ophthalmic solution has been reported to increase the pigmentation of the iris, periorbital tissue (eyelid), and eyelashes. Pigmentation is expected to increase as long as travoprost is administered. After discontinuation of travoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. The long-term effects of increased pigmentation are not known. While treatment with TRAVATAN Z® Solution can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly. Eyelash Changes —TRAVATAN Z® Solution may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, thickness, and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment. Intraocular Inflammation —TRAVATAN Z® Solution should be used with caution in patients with active intraocular inflammation (e.g. uveitis) because the inflammation may be exacerbated. Macular Edema — Macular edema, including cystoid macular edema, has been reported during treatment with travoprost ophthalmic solution. TRAVATAN Z® Solution should be used with caution

J©o2013 u r nNovartis a l o f t 5/13 h e ATRV13049JAD merican Pharmacists Association

in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema. Angle-closure, Inflammatory, or Neovascular Glaucoma — TRAVATAN Z® Solution has not been evaluated for the treatment of angle-closure, inflammatory, or neovascular glaucoma. Bacterial Keratitis —There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial. Use With Contact Lenses —Contact lenses should be removed prior to instillation of TRAVATAN Z® Solution and may be reinserted 15 minutes following its administration. Adverse Reactions The most common adverse reaction observed in controlled clinical studies with TRAVATAN Z® Solution was ocular hyperemia, which was reported in 30 to 50% of patients. Up to 3% of patients discontinued therapy due to conjunctival hyperemia. Ocular adverse reactions reported at an incidence of 5 to 10% in these clinical studies included decreased visual acuity, eye discomfort, foreign body sensation, pain, and pruritus. In postmarketing use with prostaglandin analogs, periorbital and lid changes including deepening of the eyelid sulcus have been observed. Use in Specific Populations Use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use. For additional information about TRAVATAN Z® Solution, please see Brief Summary of full Prescribing Information on adjacent page. References: 1. Lewis RA, Katz GJ, Weiss MJ, et al. Travoprost 0.004% with and without benzalkonium chloride: a comparison of safety and efficacy. J Glaucoma. 2007;16(1):98-103. 2. Gross RL, Peace JH, Smith SE, et al. Duration of IOP reduction with travoprost BAK-free solution. J Glaucoma. 2008;17(3):217-222.

j apha.org

MAR /APR 2014 | 54:2 |

JAPhA 109

USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C Teratogenic effects: Travoprost was teratogenic in rats, at an intravenous (IV) dose up to 10 mcg/kg/day (250 times the maximal recommended human ocular dose (MRHOD), evidenced by an increase in the incidence of skeletal malformations as well as external and visceral malformations, such as fused sternebrae, domed head and hydrocephaly. Travoprost was not teratogenic in rats at IV doses up to 3 mcg/kg/day (75 times the MRHOD), or in mice at subcutaneous doses up to 1 mcg/kg/day (25 times the MRHOD). Travoprost produced an increase in post-implantation losses and a decrease in fetal viability in rats at IV doses > 3 mcg/kg/day (75 times the MRHOD) and in mice at subcutaneous doses > 0.3 mcg/kg/day (7.5 times the MRHOD).

BRIEF SUMMARY OF PRESCRIBING INFORMATION INDICATIONS AND USAGE TRAVATAN Z (travoprost ophthalmic solution) 0.004% is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. ®

DOSAGE AND ADMINISTRATION The recommended dosage is one drop in the affected eye(s) once daily in the evening. TRAVATAN Z (travoprost ophthalmic solution) should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the intraocular pressure lowering effect. ®

Reduction of the intraocular pressure starts approximately 2 hours after the first administration with maximum effect reached after 12 hours. TRAVATAN Z Solution may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart. ®

CONTRAINDICATIONS None WARNINGS AND PRECAUTIONS Pigmentation Travoprost ophthalmic solution has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes. Pigmentation is expected to increase as long as travoprost is administered. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of travoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. The long term effects of increased pigmentation are not known. Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with TRAVATAN Z (travoprost ophthalmic solution) 0.004% can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly. ®

Eyelash Changes TRAVATAN Z Solution may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, thickness, and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment. ®

Intraocular Inflammation TRAVATAN Z Solution should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated. ®

Macular Edema Macular edema, including cystoid macular edema, has been reported during treatment with travoprost ophthalmic solution. TRAVATAN Z Solution should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema. ®

Angle-closure, Inflammatory or Neovascular Glaucoma TRAVATAN Z Solution has not been evaluated for the treatment of angle-closure, inflammatory or neovascular glaucoma. ®

Bacterial Keratitis There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface. Use with Contact Lenses Contact lenses should be removed prior to instillation of TRAVATAN Z Solution and may be reinserted 15 minutes following its administration. ®

ADVERSE REACTIONS Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The most common adverse reaction observed in controlled clinical studies with TRAVATAN (travoprost ophthalmic solution) 0.004% and TRAVATAN Z (travoprost ophthalmic solution) 0.004% was ocular hyperemia which was reported in 30 to 50% of patients. Up to 3% of patients discontinued therapy due to conjunctival hyperemia. Ocular adverse reactions reported at an incidence of 5 to 10% in these clinical studies included decreased visual acuity, eye discomfort, foreign body sensation, pain and pruritus. Ocular adverse reactions reported at an incidence of 1 to 4% in clinical studies with TRAVATAN or TRAVATAN Z Solutions included abnormal vision, blepharitis, blurred vision, cataract, conjunctivitis, corneal staining, dry eye, iris discoloration, keratitis, lid margin crusting, ocular inflammation, photophobia, subconjunctival hemorrhage and tearing. ®

®

®

®

Nonocular adverse reactions reported at an incidence of 1 to 5% in these clinical studies were allergy, angina pectoris, anxiety, arthritis, back pain, bradycardia, bronchitis, chest pain, cold/flu syndrome, depression, dyspepsia, gastrointestinal disorder, headache, hypercholesterolemia, hypertension, hypotension, infection, pain, prostate disorder, sinusitis, urinary incontinence and urinary tract infections. In postmarketing use with prostaglandin analogs, periorbital and lid changes including deepening of the eyelid sulcus have been observed.

110 JAPhA | 5 4 :2 | M AR/AP R 2014

ja p h a .org

In the offspring of female rats that received travoprost subcutaneously from Day 7 of pregnancy to lactation Day 21 at doses of ≥ 0.12 mcg/kg/day (3 times the MRHOD), the incidence of postnatal mortality was increased, and neonatal body weight gain was decreased. Neonatal development was also affected, evidenced by delayed eye opening, pinna detachment and preputial separation, and by decreased motor activity. There are no adequate and well-controlled studies of TRAVATAN Z (travoprost ophthalmic solution) 0.004% administration in pregnant women. Because animal reproductive studies are not always predictive of human response, TRAVATAN Z Solution should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. ®

®

Nursing Mothers A study in lactating rats demonstrated that radiolabeled travoprost and/or its metabolites were excreted in milk. It is not known whether this drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TRAVATAN Z Solution is administered to a nursing woman. ®

Pediatric Use Use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use. Geriatric Use No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients. Hepatic and Renal Impairment Travoprost ophthalmic solution 0.004% has been studied in patients with hepatic impairment and also in patients with renal impairment. No clinically relevant changes in hematology, blood chemistry, or urinalysis laboratory data were observed in these patients. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Two-year carcinogenicity studies in mice and rats at subcutaneous doses of 10, 30, or 100 mcg/kg/day did not show any evidence of carcinogenic potential. However, at 100 mcg/kg/day, male rats were only treated for 82 weeks, and the maximum tolerated dose (MTD) was not reached in the mouse study. The high dose (100 mcg/kg) corresponds to exposure levels over 400 times the human exposure at the maximum recommended human ocular dose (MRHOD) of 0.04 mcg/kg, based on plasma active drug levels. Travoprost was not mutagenic in the Ames test, mouse micronucleus test or rat chromosome aberration assay. A slight increase in the mutant frequency was observed in one of two mouse lymphoma assays in the presence of rat S-9 activation enzymes. Travoprost did not affect mating or fertility indices in male or female rats at subcutaneous doses up to 10 mcg/kg/day [250 times the maximum recommended human ocular dose of 0.04 mcg/kg/day on a mcg/kg basis (MRHOD)]. At 10 mcg/kg/day, the mean number of corpora lutea was reduced, and the post-implantation losses were increased. These effects were not observed at 3 mcg/kg/day (75 times the MRHOD). PATIENT COUNSELING INFORMATION Potential for Pigmentation Patients should be advised about the potential for increased brown pigmentation of the iris, which may be permanent. Patients should also be informed about the possibility of eyelid skin darkening, which may be reversible after discontinuation of TRAVATAN Z (travoprost ophthalmic solution) 0.004%. ®

Potential for Eyelash Changes Patients should also be informed of the possibility of eyelash and vellus hair changes in the treated eye during treatment with TRAVATAN Z Solution. These changes may result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are usually reversible upon discontinuation of treatment. ®

Handling the Container Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. When to Seek Physician Advice Patients should also be advised that if they develop an intercurrent ocular condition (e.g., trauma or infection), have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physician’s advice concerning the continued use of TRAVATAN Z Solution. ®

Use with Contact Lenses Contact lenses should be removed prior to instillation of TRAVATAN Z Solution and may be reinserted 15 minutes following its administration. ®

Use with Other Ophthalmic Drugs If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes between applications. Rx Only U.S. Patent Nos. 5,631,287; 5,889,052, 6,011,062; 6,235,781; 6,503,497; and 6,849,253

ALCON LABORATORIES, INC.

J o u r n a l o f t h e A m e r i c a n P h a r m a c i s Fort t s Worth, A s s oTexas c i a76134 t i o n USA

© 2006, 2010, 2011, 2012 Novartis 5/13 TRV13021JAD TRV13049JAD 4/13

ASSOCIATION REPORT

Increasing member awareness and engagement. Members of the Academy are directly involved with developing content and conducting programing for each Annual Meeting. The APhA2014 program includes Academy business meetings, APhA–APPM Delegate Caucuses, nine SIG business meetings, an open forum with a focus on pharmacists’ patient care services and emerging issues, and networking events. In addition to Annual Meeting programming throughout the 2013– 14 Academy year, Academy members were involved in reviewing APhA documents, submitting items for e-Communities, and providing feedback on guidelines and position statements from other pharmacy organizations and government agencies. Academy members responded to inquiries from APhA staff on issues such as ACOs; compounding; prescription drug abuse and misuse; health information technology (HIT); implementation and payment as related to Medicare Part D; accreditation standards; patientand drug-safety-related issues; quality measures; and provider status. Facilitating member identification and referral. To accomplish the Association’s work, APhA is routinely in need of experts from APhA–APPM to assume a leadership role in both external and internal groups. Several times during 2013–14, Academy leadership identified members who were then nominated or appointed by APhA to serve in positions such as Pharmacy Quality Alliance (PQA) workgroups. Developing and implementing APhA–APPM Workgroups. In 2013, APhA–APPM leadership, under the charge of APhA President Simenson, embarked on an effort to develop the structure and function of workgroups within the Academy. These workgroups focused on defined tasks and provided an opportunity for members to become engaged and contribute to the Asso-

ciation’s work. APhA–APPM launched three workgroups in 2013: ❚❚ Medical Home Workgroup: In response to a request from the Patient-Centered Primary Care Collaborative, APhA– APPM formed a workgroup to review best-practice submissions for training health care practitioners in medical homes. In a multiphase project, Academy workgroup members reviewed programs and made recommendations on strong and innovative programs with interdisciplinary-based care training practice in collaborative care models (e.g., patientcentered medical homes). The workgroup finished its work by identifying key elements of successful medical home training programs from a pharmacy perspective. ❚❚ Medical Resident and Practice Training Module Workgroup: In response to a request from the American College of Physicians (ACP), a workgroup was formed to obtain pharmacist feedback on two prescribing modules in an ACP-developed curriculum for practicing physicians and medical resident trainees on high-value, costconscious care. The workgroup—comprising Academy officers, SIG leaders, and former APhA Presidents—reviewed the materials and provided expert feedback. ❚❚ Community Pharmacy Practice Evaluation Workgroup: In an effort to advance the quality of pharmacy care delivery and to prepare for accreditation of community pharmacy practices, APhA staff convened a workgroup of 29 Academy member volunteers to perform a gap analysis of available community pharmacy practice resources. Based upon information collected in 2013, the workgroup will try to identify any gaps in

Journal of the American Pharmacists Association

j apha.org

resources or tools to guide pharmacies in the development of programs that elevate practice. Gratitude APhA volunteers have a wealth of talent and passion for the profession, and we can all be proud of APhA’s application of resources toward harnessing and organizing that energy via its dedicated staff. I would like to extend a huge thank you to APhA Director of Practice Development and Research Margaret Tomecki for her APhA–APPM facilitation, coordination, and tireless communication. Additionally, a note of appreciation to APhA Senior Director of Practice and Science Development Martha Paterson for her years of service to APhA—we wish her the best, as she has recently left to pursue another opportunity in association management. A special thank you is also extended to Jim Owen, Anne Burns, and Stacie Maass in APhA’s Pharmacy Practice and Government Affairs Division for their work to advance practice and provider status. Thanks also to APhA Director of New Practitioner Development Tom English for his work with new practitioners and to APhA Administrative Manager of Professional Affairs Meredith Nelson for helping with many of the day-to-day operations of the Academy. In summation In 2013–14, the Academy’s work was empowered and enhanced throughout the organization by dozens of very dedicated, capable individuals who truly believe in the vision and mission of APhA, particularly the APhA elected leadership and member volunteers. It is a delight to work with such a talented and dedicated group of professionals. As we look forward to the 2014– 15 Academy year and my final year as president, the opportunities are many and our challenges on the MAR /APR 2014 | 54:2 |

JAPhA 111

ASSOCIATION REPORT

provider status front are large. With your engagement, our Association can achieve great things for our profession, and we can make a difference in the lives of our patients as health care providers. As I mentioned earlier, we have made significant progress in advancing the profession, but we still have a tremendous amount of work to do. The future rests with you! Get involved in APhA–APPM today and make a difference for the profession! Nicki Hilliard, PharmD, MHSA, BCNP, FAPhA Professor of Pharmacy Practice College of Pharmacy University of Arkansas for Medical Sciences Little Rock 2013–14 President APhA–APPM [email protected]

APhA–APRS I hope that the tradition of inviting academy presidents (and academy support staff) to prepare written annual reports for publication in the Journal is seen by Association members as more than merely ceremoFassett nial. Your Association is increasingly recognized as a respected and credible national and international voice for the profession during a period of rapid change in health care. APhA does much of its work through the involvement of members in the three academies, and these reports provide an important means for the academy presidents to be accountable to their members. Please take time to read these reports and then become engaged in your own academy in 2014–15. Science & practice The relationship of the sciences to the profession of pharmacy has al112 JAPhA | 5 4 :2 | M AR/AP R 2014

ways been important, and perhaps never as much so as when facing rapid change in the structure of and policy for providing patient care, the technology for delivering that care, and continued advances in understanding the fundamentals of diseases and their treatment. A recent report from University of California, San Francisco, cited eight top trends facing health care in 2014: data-rich wearable devices, cancer immunotherapy, genome editing, the human microbiome, patient-centered medical homes, cell therapy, early translation of research to practice, and health care value (Top trends in health sciences for 2014. www.ucsf.edu/ news/2013/12/110666/top-trendshealth-sciences-2014. Updated December 18, 2013. Accessed February 17, 2014). Although other sources might suggest a different list of challenges, any similar set of such trends would clearly have an important impact on our profession, as well as require the best efforts of pharmacists engaged in the basic pharmaceutical sciences, clinical sciences, or social and administrative sciences. The APhA Academy of Pharmaceutical Research and Science (APhA– APRS) provides the home within the Association for these scientists, as it strives to provide meaningful programs for its members and serves as the primary scientific voice for the profession—promoting the translation of research into pharmacy practice. In addition to the activities of Academy sections and their leaders, APhA–APRS supports the work of the APhA Science Officer. The Academy also promotes interest among student pharmacists and new practitioners in careers as scientists through the efforts of the Postgraduate Officer and the Postgraduate Committee. By working closely with members and leaders in the other APhA academies, the 2013–14 efforts of APhA–APRS led to clearer measures of the academies’ contribuja p h a .org

tions to achieving the strategic priorities of the Association. This year’s accomplishments, summarized below, are the direct result of the efforts of dedicated volunteers, Academy leaders, and the unstinting dedication and expertise of APhA staff. Four key initiatives During 2013–14, Academy leaders and members directly contributed to APhA’s Strategic Plan objectives, specifically in the areas of transforming the role of the pharmacist, empowering members, advocating for the profession, and developing leaders. This was achieved through APhA–APRS member participation in four key initiatives: member engagement and involvement, member identification and referral, environmental scan of research, and workgroups. Member engagement and involvement. The Academy continued to work with staff on implementing mechanisms to increase the number of APhA–APRS members participating in Academy activities during 2013-2014. More than 55 APhA–APRS members served the Academy in a volunteer capacity this past year. We would like to thank those members who have chosen to support the Academy, and we would welcome new members to become involved! We hope that you will feel at home at APhA and will consider both elected and non-elected opportunities available through APhA–APRS. We need your help to ensure that the scientific voice of APhA remains strong. Throughout the year, APhA– APRS members advanced policy discussions and provided scientific expertise on such issues as medication therapy management (MTM) services, transfer of patient records after sale of a pharmacy, practicebased research, health information technology, the pharmacist’s role in pharmacogenomics, biosimilars, and compounding. Twentytwo delegates served during the

Journal of the American Pharmacists Association

ScriptPro Perfect Integration. ®

Journal of the American Pharmacists Association

j apha.org

MAR /APR 2014 | 54:2 |

JAPhA 113

ASSOCIATION REPORT

APhA2013 House of Delegates, and one APhA–APRS member was identified to serve on the APhA Political Action Committee Board of Governors. The Academy will continue to actively participate in the House of Delegates policy development process and in other APhA Committees, and we welcome your support. APhA–APRS scientists continue to serve as APhA appointees on Pharmacy Quality Alliance (PQA) Workgroups. The work of these groups to develop quality-measure concepts, educate pharmacists and other stakeholders about the importance of pharmacy quality, and advocate for broad dissemination of pharmacy quality measures in the marketplace is commendable and important for advancing pharmacist services. APhA–APRS members made significant contributions to APhA’s scientific publishing portfolio as authors, peer reviewers, editors, and contributors. The Journal of Pharmaceutical Sciences (JPharmSci) remains the authoritative journal for pharmaceutical sciences around the world. It is the official scientific journal of the Board of Pharmaceutical Sciences of the International Pharmaceutical Federation and is published in cooperation with the American Association of Pharmaceutical Scientists. The Academy would also like to commend Andy Stergachis, BPharm, PhD, Editor-in-Chief of the Journal of the American Pharmacists Association (JAPhA), and Associate Editors Jeanine P. Abrons, PharmD, MS; Lauren B. Angelo, PharmD, MBA; Lisa M. Guirguis, BScPharm, MSc, PhD; Spencer E. Harpe, PharmD, PhD, MPH; Pamela Heaton, PhD, BSPharm, MS; and Salisa C. Westrick, PhD, for their efforts in continuing the fine work of Journal editors who preceded them in publication of high-quality research. The APhA–APRS programming at APhA2013 was evaluated by the 114 JAPhA | 5 4 :2 | M AR/AP R 2014

Education Standing Committee during the 2013 Academies Leadership Meeting. Committee members’ recommendations have been incorporated into programming for APhA2014, including robust content for the Academy’s Economic, Social, and Administrative Sciences (ESAS) Section’s “Science Day.” Science-related educational sessions included methodology sessions, contributed papers, poster and podium sessions, research roundtables, interdisciplinary research sessions, policy sessions, and postgraduate programming. Section-specific programming included business meetings, judging of poster and podium sessions, and recognition of Academy award recipients and volunteers. Member identification and referral. APhA–APRS continues to make member identification and volunteerism a high priority by conducting personal outreach to colleagues and encouraging members to participate more fully in Academy activities. Through their involvement in APhA’s effort to showcase the value of pharmacists’ patient care services, APhA–APRS Clinical Sciences and ESAS Section officers have identified section members involved in innovative practices or research to be profiled as part of APhA’s “Practicing as a Provider” series in the provider status section of pharmacist.com. The APhA–APRS Postgraduate Advisory Committee continued to encourage student pharmacists to pursue advanced degrees in the pharmaceutical sciences. Academy postgraduate scientists participated in the APhA–Academy of Student Pharmacists (ASP) Midyear Regional Meetings, wrote an article in Student Pharmacist summarizing available opportunities within the pharmaceutical sciences, and developed programming for APhA2014. The APhA2014 Postgraduate Forum topic is “Building Better Bridges: Strategies for Successful Collaboraja p h a .org

tion in Interdisciplinary Research.” All are welcome to participate in this session. The Postgraduate Advisory Committee also developed a twopage resource to assist members in identifying funding opportunities and acquiring grants. Environmental scan of research. APhA Science Officer Patrick Clay, PharmD, FCCP, CCTI, led the ESAS MTM Best Evidence Task Force (formed during 20122013) and the APhA Evidence for Pharmacists Services Expert Panel to review published literature and identify best evidence available that demonstrates the value of pharmacists’ provided services. The best evidence identified by these panels was incorporated into an independent white paper assessing the evidence base for the value of pharmacists across various dimensions and was vital in the development of APhA’s comments submitted on the draft report of the Medication Therapy Management Systematic Review conducted by the Agency for Healthcare Research and Quality (AHRQ). APhA–APRS also gathered information on how pharmacists have established a return on investment (ROI) for their provided services and previous and ongoing research that has been conducted in this area. The Academy further explored the development of a standardized calculation of ROI to outline a consistent method of reporting for papers submitted to JAPhA. APhA–APRS workgroups. APhA–APRS leadership has spearheaded an effort to increase member engagement and recruited volunteers to contribute their expertise to more than 18 committees and workgroups that met throughout the year. A workgroup led by Patrick Clay was convened to assist APhA with developing comments in response to the AHRQ Medication Therapy Management Key Questions. These comments were incorporated into the final research design. This same workgroup pro-

Journal of the American Pharmacists Association

ASSOCIATION REPORT

vided comments on the results published in the draft report. The APhA–APRS officers identified members with expertise in specialized areas of pharmaceutical sciences and assembled workgroups that informed and assisted APhA staff. The pharmacogenomics workgroup and the biosimilars task force discussed FDA guidance and reviewed recent literature to develop comments submitted to regulatory agencies and other organizations and to establish APhA’s current position in these areas. Former APhA–APRS Clinical Sciences Section Officer CoraLynn Trewet, MS, PharmD, led an expert panel to review the Obesity Guidelines established by the American College of Cardiology (ACC), the American Heart Association (AHA), and the Obesity Society, as well as ACC/AHA guidelines on the Treatment of Blood Cholesterol in advance of public release. The panel discussed the recommendations, identified areas that would impact the current practice of pharmacy, and assessed if the guidelines should receive APhA endorsement. Awards and recognition APhA–APRS honors outstanding scientists and published research in the areas of the basic; clinical; and economic, social, and administrative sciences through its Academy Awards. The 2013-2014 APhA– APRS Awards Committee reviewed nominations and selected recipients for the following awards to be presented at APhA2014: ❚❚ Tyler Prize for Stimulation of Research: Stephen W. Schondelmeyer, BS, PharmD, MAPubAdm, PhD, FAPhA ❚❚ Research Achievement Award: Marie Chisholm-Burns, PharmD, MPH ❚❚ Ebert Prize: Sandeep Kumar, PhD, for the article, Relationship between potential aggregationprone regions and HLA-DRbinding T-cell immune epitopes: implications for rational

design of novel and follow-on therapeutic antibodies. J Pharm Sci. 2012;101(8):2686–701. Coauthors: Mark A. Mitchell, Bonita Rup, and Satish K. Singh. ❚❚ Clinical Research Paper Award: Daniel R. Touchette, PharmD, MA, FCCP, for the article, Safety-focused medication therapy management: a randomized controlled trial. J Am Pharm Assoc. 2012;52(5):603–12. Co-authors: Andrew L. Masica, Rowena J. Dolor, Glen T. Schumock, Young Ku Choi, Yoonsang Kim, and Scott R. Smith. ❚❚ Wiederholt Prize: Bonnie L. Svarstad, PhD, for the article, Improving refill adherence and hypertension control in black patients: Wisconsin TEAM trial. J Am Pharm Assoc. 2013;53(5):520–9. Co-authors: Jane Morley Kotchen, Theresa I. Shireman, Roger L. Brown, Stephanie Y. Crawford, Jeanine K. Mount, Pamela A. Palmer, Eva M. Vivian, and Dale A. Wilson. ❚❚ APhA fellows selected by APhA–APRS: Tina Penick Brock, BSPharm, MS, EdD; Carolyn M. Brown, PhD; CDR Joshua W. Devine, PharmD, PhD; Joel F. Farley, BSPharm, PhD; Kevin C. Farmer, BSPharm, PhD; Suzan N. Kucukarslan, PhD; Sidney J. Stohs, PhD; CoraLynn Trewet, MS, PharmD, BCPS, CDE; Donna S. WestStrum, RPh, PhD Academy governance Three new Academy-elected leaders will be installed at the 2014 APhA Annual Meeting in Orlando, FL, and will serve on the APhA–APRS Executive Council: Bill McLaughlin, PhD, of Tennessee, as 2014–15 Chair-elect for the Basic Sciences Section; Julie Oestreich, PharmD, PhD, of Nebraska as 2014–15 Chairelect for the Clinical Sciences Section; and Joel F. Farley, BSPharm, PhD, of North Carolina as 2014–15 Chair-elect for the ESAS Section.

Journal of the American Pharmacists Association

j apha.org

Reflections on the year My second year as APhA–APRS President benefitted greatly from the generous collaboration with APhA–Academy of Pharmacy Practice and Management (APPM) President Nicki Hilliard. APhA–APRS and APhA–APPM leadership have united in continuing the key role of the academies in informing the strategic direction of the Association through direct representation of our members to the Board of Trustees. In the Academy executive leadership (Melody Ryan, Robin Zavod, Leon Shargel, Robert DiCenzo, Michael Wincor, Richard Hansen, Donna West-Strum, and Antoinette Coe), I discovered willing and enthusiastic partners committed to always improving the value of APhA–APRS membership and holding the Academy accountable for contributing to APhA’s long-term success. The continued work of APhA Science Officer Clay in helping the Academy carry out its priorities deserves acknowledgment one more time. It is far from bromidic to note that our aspiring and new practitioners are the heart of any future successes of the profession and the Association. I have had the true pleasure of working on the Board of Trustees with APhA–Academy of Student Pharmacists (ASP) President Brandi Hamilton; like my fellow trustees, I have been awed by her enthusiasm, excellence, and endurance. I also have the pleasure of working with leaders of the APhA– APRS Postgraduate Committee, which grew under Matt Witry in 2012–13 and Toni Coe this past year to be increasingly effective in encouraging and informing student pharmacists who are pursuing postgraduate training or postgraduate education. APhA staff members were critical contributors to the Academy and its members this year. The Academy would have few achievements without the work of Martha Paterson, Margaret Tomecki, Meredith Nelson, Jim Owen, and Stacie Maass. MAR /APR 2014 | 54:2 |

JAPhA 115

ASSOCIATION REPORT

Martha Paterson will be sorely missed by APhA as she moves on to significant responsibilities with another national association; her contributions will not be forgotten. I wish for APhA members to understand that your elected leadership (headed this year by 2013–14 APhA President Steve Simenson) and trustees are working yearround to advance the profession of pharmacy and to achieve the recognition of pharmacists as the health professionals responsible for providing patient care that ensures optimal medication therapy outcomes. I am truly grateful for the opportunity to have served the Association and the Academy for 2 years and yet look forward to turning the leadership of APhA–APRS over to incoming President Melody Ryan. William E. Fassett, BSPharm, PhD, FAPhA Professor of Pharmacy Law & Ethics College of Pharmacy Washington State University Spokane 2012–14 President APhA–APRS [email protected]

APhA–ASP Since APhA–ASP was established in 1969 as the Student American Pharmaceutical Association (SAPhA), our Academy has served as the collective voice of student Hamilton pharmacists and been instrumental in their professional development. This is a special time for APhA–ASP as we celebrate its 45th year and the 30th anniversary of the National Patient Counseling Competition. This year, with a goal of fostering both the personal and professional growth of student pharmacists, the Academy implemented the presidential theme “Be the Change,” which focused on being agents of 116 JAPhA | 5 4 :2 | M AR/AP R 2014

positive change in our profession and our communities. During this time of evolution for the profession, it is paramount for its future leaders to continually drive positive change. Strategic planning The members of the 2013–14 APhA– ASP National Executive Committee (NEC) were APhA–ASP National President Brandi Hamilton, National President-elect Nicholas Capote, National Member-at-large Joshua Cahill, National Member-at-large Brian Donahue, and Speaker of the House J.T. Fannin. In April 2013, the NEC met for its first business meeting and set goals for the Academy for the coming year. Our goals focused on the following five areas: (1) membership, (2) enhancing the pharmacist’s role in patient care to improve public health, (3) promoting political and public advocacy, (4) leadership and professional development, and (5) student involvement in the provider status initiative. The NEC was joined by four of the five the APhA– ASP National Standing Committees—Communication, Education, International, and Policy—at the Academies Leadership Meeting (the Awards Standing Committee meets in November), where each committee set goals and objectives to support the Academy’s vision for the year. Additionally, student leaders collaborated with APhA– APPM and APhA–APRS leaders to strategize for the Association for the upcoming year. The APhA–ASP NEC met again in July 2013 and January 2014 to revisit goals and objectives and organize programming for the remainder of the year. In July during the APhA–ASP Summer Leadership Institute, we launched new core positions for each chapter executive committee and renamed some existing positions in the interest of maintaining standardization on the local level. At the January Business Meeting, our newly elected regional offija p h a .org

cers joined us for orientation to PhA and to their respective positions, as well as planning for the coming year. Our APhA–ASP regional officers are as follows: ❚❚ Regional Delegates: Adam Heiermann (Region 1), Matt Marianski (Region 2), Lauren Bode (Region 3), Jessica Comstock (Region 4), Meena Murugappan (Region 5), Jeffrey Van Liew (Region 6), Megan Carroll (Region 7), and Kaitlyn Skulkan (Region 8) ❚❚ Regional Members-at-Large: Jonathan Lee (Region 1), Aeree Choi (Region 2), Joseph Will Beaty (Region 3), Samantha Landolfa (Region 4), Joshua Rose (Region 5), Puja Patel (Region 6), Sydney Root (Region 7), and Nestle Jane Austero (Region 8) ❚❚ Midyear Regional Meeting (MRM) Coordinators: Brianna Luft (Region 1), Brooke Morris (Region 2), Allie Jo Shipman (Region 3), Kasandra Chambers (Region 4), Jenalee Schwab (Region 5), Stephanie Garza (Region 6), Melanie Sheldon (Region 7), and Kelsea Gallegos (Region 8) Membership development Representing nearly 34,000 student pharmacists from each school and college of pharmacy in the United States and Puerto Rico, APhA–ASP remains the collective voice of student pharmacists. In fall 2013, the APhA–ASP NEC and APhA Student Development Staff conducted 43 student outreach visits, including visits to Puerto Rico, our newest chapter at the University of North Texas System, and eight video teleconference visits. During these visits we promoted APhA membership and its extensive benefits, MRMs and APhA2014, the dual membership program and New Practitioner Network, the APhA Political Action Committee, and the APhA Foundation. We also encouraged student involvement in the provider status initiative and emphasized the importance of collaboration with state associations.

Journal of the American Pharmacists Association

ORIGINAL PRESCRIPTION STRENGTH WITHOUT A PRESCRIPTION

CALM THE INFLAMMATORY RESPONSE

BREATHE IN THE DAY

Control nasal inflammation with Nasacort, the first and only over-the-counter INS* From the most effective class of treatment for allergic rhinitis (AR) Works differently than oral antihistamines and nasal decongestant sprays 24-hour† relief for patients with moderate to severe AR *Intranasal steroid.

J o u r n a l †Itomay f t htake e Aupmtoeone r i cweek a n Pofhdaily a r muse a cfor i s24-hour t s A s relief. sociation

j apha.org

Triamcinolone acetonide

MAR /APR 2014 | 54:2 |

JAPhA 117 Chattem, Inc. 6010 ©2014

ASSOCIATION REPORT

APhA–ASP Standing Committees The Academy’s success is a result of the hard work of the APhA–ASP Awards, Communications, Education, International, and Policy Standing Committees, and this year was no exception. The 2013-2014 APhA–ASP Awards Standing Committee was chaired by Nicholas Capote and included Vice Chair Michael Wolcott and members John Flores, Mika Fujinaka, and Maggie Oser. The committee met in November to select Chapter Achievement Awards recipients and these individual award winners: ❚❚ Linwood F. Tice Friend of APhA–ASP Award: Marialice Bennett, BSPharm ❚❚ APhA Outstanding Dean Award: Phillip Oppenheimer, PharmD, University of the Pacific Thomas J. Long School of Pharmacy and Health Sciences ❚❚ APhA Outstanding Chapter Advisor Award: Carol A. Bugdalski-Stutrud, BSPharm, Wayne State University Eugene Applebaum College of Pharmacy and Health Sciences ❚❚ APhA Student Leadership Awards: Amy Kiskaddon, University of Florida College of Pharmacy; Ashley Potter, South Dakota State University College of Pharmacy; Alicia Yeh, University of the Pacific Thomas J. Long School of Pharmacy and Health Sciences; and Amanda Zessin, University of the Incarnate Word Feik School of Pharmacy Notable changes to the awards that will be presented at the APhA Annual Meeting and Exposition include the addition of first and second national runners-up for each of the patient care projects. Once there were 36 patient care project awards (32 regional and 4 national); now there are 44 awards (32 regional and 12 national). This allows us to recogize more of the outstanding achievements of our chapters and aligns with the Generation Rx awards format. 118 JAPhA | 5 4 :2 | M AR/AP R 2014

The 2013–14 APhA–ASP Communications Standing Committee focused on enhancing and optimizing the Academy’s social media strategy. This included closing our regional Facebook pages and encouraging members to participate in our national Facebook page for improved continuity and expanded networking among members. The national Facebook page has more than 5,000 likes, up from just over 3,000 a year ago. Our Twitter account @APhAASP, launched last year, has more than 1,500 followers. This marks a near doubling of our outreach through this medium in the past year. Our APhA–ASP webinars have gained momentum with the continuation and expansion of current programs, such as our series for chapter leaders, and the addition of new webinars throughout the year. The Communications Standing Committee also worked on the fifth annual PharmFlix competition. Chapters submitted 58 videos, a new record, this year with the theme “Be the Change.” The top five humorous and the top five informative videos will be highlighted at APhA2014. The 2013–14 APhA–ASP Communications Standing Committee was chaired by Brian Donahue and included Vice Chair Hazel Atienza and members Mohammed Jalloh, Shawlien Lie, and Adam Loyson. The 2013–14 APhA–ASP Education Standing Committee was committed to streamlining our meeting programing. The committee hosted webinars for student pharmacists in areas such as followership – a follow-up to the presentation given at the MRMs. The 2013–14 APhA–ASP Education Standing Committee was chaired by Joshua Cahill and included Vice Chair Sara Wettergreen and members Maureen Campion, Jamie Kraemer, and Negin Moon. The APhA–ASP International Committee – the United States’ representatives to the International Pharmaceutical Students Federaja p h a .org

tion (IPSF) – promoted a global perspective of pharmacy, continued the integration of international issues into the Academy’s activities, and was actively involved on the international level. APhA–ASP/ IPSF members attended the 59th annual World Congress in Utrecht, Netherlands. The United States was well represented; Sheena Patel and Miranda Law, International Standing Committee members, as well as Grace Chun and Hend Berry, were elected to international leadership positions in IPSF. The 2013–14 APhA–ASP International Standing Committee includes National Contact Person Cory Nelson, Student Exchange Officer Ashley Potter, Student Exchange Officer Assistant Colleen O’Connoll, and National Project Coordinator Van Duong. The 2013–14 APhA–ASP Policy Standing Committee focused a significant amount of time and effort on finding and implementing ways to engage students in political advocacy in fresh, new ways this year. Highlights included the initiation of pre-MRM webinars for chapter delegates and the reformatting of the APhA PAC fundraiser. The 2013–14 APhA–ASP Policy Standing Committee was chaired by J.T. Fannin and included Vice Chair Susan Dickey and members Jerod Braschler, Eliza Daubert, and Brian Primeaux. Leadership and professional development This year, 176 student leaders, two members of the APhA New Practitioner Advisory Committee, and five chapter advisors attended the 2013 APhA–ASP Summer Leadership Institute (SLI). To help launch the “Be the Change” theme and serve as an icebreaker, student pharmacists brought their favorite children’s book to the meeting. After sharing what the books meant to them, all books were collected (more than 160 in all) and donated to Children’s National Medical Center. During this meeting, attendees

Journal of the American Pharmacists Association

ASSOCIATION REPORT

took advantage of networking and leadership development opportunities, gaining extensive knowledge and useful tools to take back to their chapters. Significant changes were made to the APhA–ASP MRMs this year. We piloted our alliance structure, holding a joint meeting for Regions 1 and 2 and also for Regions 7 and 8. A new attendance record was set for the MRMs this year, with 2,975 total attendees. Meetings featured leadership and professional development workshops, education sessions, and the APhA–ASP policy process. Each chapter had the opportunity to recognize one member who has been an agent of positive change at the local level; these members were celebrated and presented with a certificate. The Chapter Showcase, new this year, allowed chapters to share their outstanding work with attendees, promoted the exchange of ideas, and facilitated networking among members. During the Closing Business Sessions, 70 proposed resolutions were passed and forwarded to the APhA–ASP Resolutions Committee for their consideration. Patient care projects APhA–ASP members are committed to patient care; last year we conducted more than 4,050 events, screened more than 251,000 patients and reached more than 21.3 million through public relations activities. By participating in Operation Diabetes, student pharmacists provided screening services to more than 64,000 patients in the effort to overcome this life-threatening disease. More than 93,000 patients were screened through Operation Heart efforts, with an additional 132,000 receiving health and wellness services. During the last reporting cycle, Operation Self-Care–our newest Patient Care Project–continued to focus primarily on heartburn as the project transitioned. Student pharmacists screened nearly 13,000 patients for heartburn and another 3,500 for other self-care conditions.

Through Operation Immunization, APhA–ASP members immunized 77,868 individuals and educated another 10.7 million. APhA– ASP continues to partner with the Cardinal Health Foundation in support of Generation Rx, a program designed to raise the public’s awareness of the dangers of prescription drug abuse and misuse. A record number of 83 chapters participated this past year as the program continues to gain momentum. Public and political advocacy Never has there been a more important time to advocate for the profession of pharmacy, and never have student pharmacists been more eager to do exactly that. The APhA– ASP SLI began with visits to Capitol Hill; 86 students conducted 135 visits, a record, to advocate for the profession to legislators. For the first time, we also conducted a successful fundraiser for the APhA PAC during SLI, raising more than $1,000. American Pharmacists Month (APhM) was launched with a new logo and new slogan, “Know Your Pharmacist. Know Your Medicine”; this is meant to emphasize the pharmacist’s role in patient care. Throughout the month, student pharmacists promoted the profession in numerous ways. We updated our social media profile pictures to the APhM logo, posted pharmacy facts daily on social media, posted on Twitter and Facebook with #pharmacists on October 3, and took our message to the masses via radio and television. This year, the Policy Standing Committee launched an advocacy postcard challenge, combining chapter patient care activities with advocacy. The postcards highlight what a student pharmacist did for them at a particular screening event; chapters are to ask patients to fill out the postcards, which are then sent to legislators. The chapter with the most impact will be recognized at APhA2014. In January 2014, the APhA–ASP

Journal of the American Pharmacists Association

j apha.org

Resolutions Committee reviewed the 70 policy proposals that passed at the MRMs and narrowed them down to three key policies to bring to APhA2014. These focused on pharmacogenomics, pharmacists providing life-saving medications in emergency situations, and pharmacist-directed clinics. Finally, the Policy Standing Committee reformatted the APhA PAC Campaign, “Winter is Cold… But Advocacy is Hot!” with the new name, chosen by chapters, “Back the PAC.” The campaign is committed to raising funds for the APhA PAC, as well as raising awareness of how the PAC supports our profession and developing lifelong PAC supporters. External relationships Just as collaboration is vital to health care, it is a critical part of what we do in APhA–ASP. The NEC is established a closer working relationship with the APhA Foundation through exploration of collaborative opportunities. Of particular note is the establishment of the APhA–ASP National President-elect as an APhA Foundation Board member, an initiative that is completing its first full term. It is our goal to raise student pharmacists’ awareness of the great work the APhA Foundation does for the public and for the profession. This organization has continued to show its unwavering support of student pharmacists through the APhA Foundation Student Scholarship program. These scholarships recognize students for outstanding leadership and involvement in their chapters and communities. A total of 73 applications were received; the recipients of the 2014 APhA Foundation Scholarships are as follows: ❚❚ Justin Arnall: University of North Carolina Eshelman School of Pharmacy (Juan and Esperanza Luna Scholarship) ❚❚ Daniel Corwin: Albany College of Pharmacy and Health Sciences (Colonel Jerry W. Ross Scholarship) MAR /APR 2014 | 54:2 |

JAPhA 119

ASSOCIATION REPORT

❚❚

❚❚

❚❚ ❚❚

❚❚

❚❚

❚❚

❚❚ ❚❚

❚❚

❚❚

usan Dickey: The University S of Tennessee Health Science Center College of Pharmacy (Sam Kalman Scholarship) Joseph Haley: University of Florida College of Pharmacy (Charles C. Thomas Scholarship) Lindsey Hunt: Idaho State University College of Pharmacy (APhA Foundation Scholarship) Madeline King: Texas A&M Health Science Center Irma Lerma Rangel College of Pharmacy (George F. Archambault Scholarship) Kevin Lonabaugh: Shenandoah University Bernard J. Dunn School of Pharmacy (Boyle Family Scholarship) Melissa Luechtefeld: University of Missouri-Kansas City School of Pharmacy (Paul Pumpian Scholarship) Colleen O’Connell: South Dakota State University College of Pharmacy (Marvin and Joanell Dyrstad Scholarship) Brittany Oliver: Purdue University College of Pharmacy (Gloria Francke Scholarship) Claire Reuter: Xavier University of Louisiana College of Pharmacy (John A. Gans Scholarship) Lucianne West: Northeastern University Bouve College of Health Sciences School of Pharmacy (Mary Louise Andersen Scholarship) Amanda Wong: University of Southern California School of Pharmacy (Robert D. Gibson Scholarship)

120 JAPhA | 5 4 :2 | M AR/AP R 2014

Finally, APhA–ASP continued its involvement in the University of Utah School on Alcoholism and Other Drug Dependencies by sponsoring the 31st meeting of the Pharmacy Section, which continues to have the highest attendance at this meeting. Highlights of the week included presentations from the top three Generation Rx chapters; education on addiction from historical, pathophysiologic, social, and personal perspectives; the role of health professionals in treatment and counseling; social issues surrounding addiction; and shattering myths about addiction. Attendees participated in Alcoholics Anonymous, Narcotics Anonymous, Al-Anon, and other group sessions. The meeting continues to be compelling for all in attendance. Presidential theme: ‘Be the Change’ The goal of this year was to motivate student pharmacists to give back by identifying changes needed in the profession and their communities and then being the agents of that positive change. Members were encouraged to challenge the status quo in the areas of patient care, advocacy, leadership, and community service. The importance of whole patient care, not just disease care, was emphasized to remind us of our purpose as health professionals. Students were challenged to shed the white coats, put on work gloves, and actively participate in their local communities. The “Be the Change” theme came at a pivotal time in the profession from an

ja p h a .org

advocacy perspective as we actively pursue provider status, and student pharmacists demonstrated a strong desire to do their part to bring about this change. Student pharmacists rose to these lofty challenges; the last year has been one of innovation, motivation, and tireless dedication– truly a year of change. Looking to the future Going forward, the Academy’s desire is that student pharmacists will continue to be servant leaders and formidable forces of positive change throughout their careers. The skills our members gain through APhA– ASP’s numerous projects and programs prepare them to be effective leaders and change agents. That student pharmacists continue to push boundaries, demonstrate creativity, and celebrate new successes each year is a testament to the quality of these programs and the students who use them. The profession is undergoing a substantial shift, and APhA–ASP members are well prepared to be the next generation of leaders who will drive that positive change. Brandi A. Hamilton Student Pharmacist College of Pharmacy University of Arkansas for Medical Sciences Little Rock 2013–14 National President APhA–ASP [email protected] doi: 10.1331/JAPhA.2014.510

Journal of the American Pharmacists Association