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Annual Meeting Abstracts 2004 FEATURE Objective: To evaluate the analgesic efficacy and safety of three dose levels of oxymorphone immediate release (IR) compared with oxycodone IR and placebo in patients with moderate to severe postoperative pain following total hip or knee replacement surgery. Methods: This Phase III, double-blind, parallelgroup study included single- and multiple-dose parts. Opioids were terminated the day following surgery and patients developing moderate to severe pain within 9 hours were randomized to one of five groups: oxymorphone IR 10 mg, 20 mg, or 30 mg; oxycodone IR 10 mg; or placebo. Single-dose efficacy measures included total pain relief (TOTPAR) up to 8 hours or until remedication. Patients requiring remedication after 3 hours received drug every 4 to 6 hours for 48 hours for multiple-dose evaluation; placebo patients were rerandomized to active treatment. Multiple-dose efficacy was based on worst pain and global evaluations. Results: During the single-dose phase (N = 258), all oxymorphone doses were statistically superior to placebo for most end points including TOTPAR 0–8 scores (P = .05 for 10 mg and P = .001 for 20 and 30 mg) and a statistically significant dose-response was observed (P < .001). The median time to meaningful pain relief was significantly shorter in all oxymorphone groups (1 hour) than in placebo (1.5 hours; P = .05). Treatment with oxycodone 10 mg was not significantly different than placebo. Adverse events were typical of opioid medication. During the multiple-dose phase (N = 161), analgesia was maintained in all groups over 48 hours. The median dosing interval was more than 9.5 hours for oxymorphone IR 30 mg and between 7 and 8 hours for the other groups. Opioid-related adverse events were similar between groups. Conclusions: Oxymorphone IR provides significant pain relief with the first dose of 10 mg, 20 mg, or 30 mg and maintains analgesia over consecutive days with multiple doses. Adverse events were mild to moderate and dose related. Original Citation: Poster Presentation: American Pain Society Annual Meeting; March 18–23, 2003; Chicago, Illinois. 22—LONG-TERM EFFECTIVENESS AND SAFETY OF A NEW ORAL OPIOID, OXY- MORPHONE EXTENDED RELEASE, FOR MODERATE TO SEVERE CANCER PAIN. Slatkin N, City of Hope National Medical Center, Amy F, Ma T, Ahdieh H, Endo Pharmaceuticals, Inc. E-mail: noellecurry@excite.com Objective: To evaluate the long-term effectiveness, safety, and dosing requirements of oxymorphone extended release (ER), a new formulation of oxymorphone, in cancer patients with chronic pain. Methods: Cancer patients with moderate to severe chronic pain who completed a previous randomized controlled trial and met study criteria entered a 2-year, open-label, extension study of oxymorphone ER every 12 hours. Patients began openlabel treatment with the oxymorphone ER dose attained in the previous study and were allowed to titrate to achieve acceptable pain relief. Oxymorphone immediate release was available as rescue medication throughout the study. Effectiveness was assessed by pain intensity scores and patient global assessment of study medication. Results: Of 44 enrolled patients (mean age = 54 years), 16 completed 52 weeks of treatment, with a median time to discontinuation of 249 days. Concomitant disease progression and other serious adverse events unrelated to study medication caused the most withdrawals over the 2 years. Patient pain was well controlled throughout the first year with every-12-hour doses of oxymorphone ER (approximate weekly average score of 30–35 mm on 100 mm visual analog scale). The mean dosage was 125 mg/day during days 0–30 and 150 mg/day during days 331–360. The mean dose of oxymorphone IR rescue medication was low (23 mg/day) during the same time period. At each study visit, 90% or more of patients rated study medication as “excellent,” “very good,” or “good” at relieving pain. Adverse events associated with opioid use included nausea, vomiting, constipation, and sedation. Conclusions: Oxymorphone ER is safe and effective in cancer patients with moderate to severe chronic pain when used long-term. Stable pain scores were maintained with little change in scheduled medication and with minimal rescue medication. Patients reported overall “excellent” to “good” satisfaction with oxymorphone. Oxymorphone ER provides a new, effective, and safe opioid treatment for moderate to severe chronic cancer pain. 23—LONG-TERM EFFECTIVENESS AND SAFETY OF A NEW ORAL OPIOID, OXY- MORPHONE EXTENDED RELEASE, FOR MODERATE TO SEVERE OSTEOARTHRI- TIS PAIN. Mcilwain H, Tampa Medical Group Research, Ahdieh H, Endo Pharmaceuticals, Inc. E- mail: vrisman@hotmail.com Objective: To evaluate the long-term effectiveness, safety, and dosing requirements of oxymorphone extended release (ER) in patients with moderate to severe chronic osteoarthritis (OA) pain uncontrolled by nonopioid analgesics. Methods: OA patients with moderate to severe chronic pain who previously completed a randomized double-blind trial and met study criteria entered a 2-year open-label extension trial of oxymorphone ER. Patients were either on active drug in the previous study and began open-label treatment at their prior stabilized dose, or had previously received placebo and began open-label treatment at oxymorphone 20 mg every 12 hours. Least, worst, and average pain intensity scores and dosage amounts were recorded. Effectiveness was assessed by pain intensity scores and patient global assessment of study medication. Results: The study included 153 patients with a mean age of 60 years. Of these, 61 patients completed 52 weeks, and 16 of 29 patients (55%) enrolled in year 2 completed the study. After an initial decrease from baseline, the mean recall scores of the least and worst pain remained stable during the first year, and the median daily dose of medication stabilized at 40 mg. More than 80% of patients rated oxymorphone as “excellent,” “very good,” or “good” at each visit. Most withdrawals (n = 49, year 1) were caused by adverse events typically associated with opioid medications, but 47% of these patients (23) had received placebo in the prior study. Conclusions: Oxymorphone ER presents a new alternative for the treatment of moderate to severe chronic OA pain, and tolerability in clinical practice can likely be improved by initiating opioid-naive patients with doses lower than 20 mg every 12 hours. Long-term use of oxymorphone ER was safe and effective in patients with OA with moderate to severe chronic pain, and patients maintained control of pain with a stable twice-daily doses of medication for 1 year. 24—TOLERABILITY AND EFFECTIVE- NESS OF OXYMORPHONE EXTENDED RELEASE IN OPIOID-NAIVE PATIENTS WITH CHRONIC PAIN. Hale M, Gold Coast Research, L.L.C., Nagle B, Photivihok G, Endo Pharmaceuticals, Inc., Drass M, Center for Pain Management. E-mail: noellecurry@excite.com Objective: To assess the tolerability and effectiveness of oxymorphone extended release (ER) following titration from a low dose (5 mg every 12 hours) in opioid-naive patients with moderate to severe chronic pain. Methods: This open-label nonrandomized study is being conducted in patients 18 years of age or older with an initial pain intensity score of 40 or more on a 100-mm Visual Analogue Scale and a pain rating of moderate or severe on a categorical scale. Patients must be opioid-naive (no prior opioid use within the past 3 months) and suboptimally responding to nonopioid analgesics. Patients initiate 2 days of therapy with oxymorphone ER 5 mg every 12 hours. Starting on day 3, patients will be titrated to a stable dose of oxymorphone ER that provides meaningful pain relief (4 or more on a 0 to 10 scale for 3 of 5 consecutive days). The titration period is not to exceed 21 days. No changes are made in concomitant nonopioid analgesics during this period. Following titration, patients are maintained with the stabilized dose of oxymorphone ER therapy for up to 6 months. Oxymorphone immediate release 5 mg is available as rescue medication during the maintenance period only. Concomitant nonopioid analgesics can be decreased or discontinued but not increased, and no new nonopioid analgesics can be added during the maintenance period. Tolerability will be assessed by the rate of discontinuations because of adverse events. Additional assessments will include average daily pain intensity, average daily dose of oxymorphone ER, rescue medication, time to stabilization, and patient and physician global assessments. Results: Data will be presented for approximately 100 patients. Conclusions: Conclusions will be presented based upon the trial results, and the implications for pharmacists will be discussed. 2004 Abstracts of Contributed Papers Vol. 44, No. 2 March/April 2004 www.japha.org Journal of the American Pharmacists Association 231 Downloaded From: http://japha.org/ on 01/25/2014
FEATURE Annual Meeting Abstracts 2004 25–A REPRODUCIBLE MODEL FOR DIS- EASE STATE MANAGEMENT AND PHAR- MACEUTICAL ACCESS FROM A FEDERAL- LY FUNDED URBAN COMMUNITY HEALTH CENTER. Talsania S, University of Illinois at Chicago, Assam A, University of Illinois at Chicago, Mile Square Health Center. E-mail: stalsa1@uic.edu Objective: To develop an effective model for expanded clinical pharmacy services and increased access to pharmaceuticals in an underserved community. Methods: The Bureau of Primary Health Care provided grant funding for clinical pharmacy demonstration projects to meet the needs of underserved communities. One of the 2002 recipients was a federally qualified urban community health center with an in-house pharmacy. To achieve the goals of the grant, the pharmacy created three integrated processes: diabetes disease state management, 340B drug program utilization, and manufacturer assistance program expansion. Before the grant was funded, pharmacists provided disease state management on a sporadic basis depending on pharmacy staffing needs. Funding from the grant enabled the pharmacy to hire a pharmacotherapist to implement structured clinical pharmacy services on a consistent basis. The focus was on patients who had type 2 diabetes mellitus with or without comorbidities. Patients were seen in a one-on-one session, and drug therapy was adjusted through a collaborative practice agreement and established protocols. An educational assessment was performed, and education was tailored to meet individual patient needs. Increased access to pharmaceuticals was achieved through the 340B drug program and expansion of manufacturer assistance programs. Clinical indicators measured included change from baseline in glycosylated hemoglobin, blood pressure, and serum lipid levels. Data on economic, education, and humanistic outcomes are also being collected, and validated instruments will be used to analyze this information. Results: Analysis for year 1 data has started and will be completed by the APhA annual meeting. Conclusions: Based on preliminary data analysis, this model will demonstrate improvement in diabetic patient outcomes and cost savings for the health center’s drug budget. The hope is that pharmacists will implement this model in their practice settings. 26—A SURVEY OF PHARMACISTS’ ACTIVITIES SUPPORTING MEDICATION ADHERENCE. Possidente C, Pfizer, Inc, Anzisi L, Pfizer, Algozzine T, Buckley T, Weathermon R, Pfizer, Inc. E-mail: carl.possidente@pfizer.com Objective: Nonadherence to prescribed drug therapy is a common and serious health care problem. The study objectives were to determine what activities were provided by pharmacists to improve medication adherence and to review pharmacists’ attitudes related to medication adherence. Methods: A 15-question written survey was distributed to pharmacists attending educational programs conducted in New York, Connecticut, New Hampshire, and Vermont from February through June 2003. The survey response rate was approximately 65%. Results: The majority of the 937 respondents were men (65%) who had been in practice for more than 20 years (58%) and were working in community practice (60%). A total of 73% of pharmacists stated they performed adherence activities. Activities most commonly provided included: verbal counseling for new prescriptions, verbal counseling not related to prescriptions, telephone consultations, and distributing written materials. Community pharmacists (86.4%) provided more activities to improve adherence than did hospital pharmacists (50.8%), (P < .0001); however, they had less time available. Hospital pharmacists tended to target patients with specific diseases more than community pharmacists. Time spent performing adherence activities did not vary between independent and chain community pharmacists. Pharmacists in practice less than 5 years provided activities to improve adherence more frequently than their peers. Time spent performing these activities decreased as years in practice increased. The most common barrier was limited time, reported by 78% of pharmacists. Some 76% of respondents agreed pharmacists have a responsibility to improve medication adherence, but 17% of pharmacists stated improving medication adherence was not their responsibility, an attitude more common with men in community practice for longer than 10 years. Overall, 92% of respondents were interested in learning more about adherence. Conclusions: Pharmacy organizations and the pharmaceutical industry have an opportunity to educate pharmacists and the public on the importance of optimizing medication adherence. 27—A UTILIZATION REVIEW OF OAB AGENTS IN A WISCONSIN MEDICAID POP- ULATION. Conner C, Cherayil G, Pfizer, Inc. E- mail: christopher.conner@pfizer.com Objective: Current estimates suggest that 17 million Americans are affected by overactive bladder (OAB). The available agents for the treatment of OAB differ with respect to formulation (immediate versus extended-release), selectivity for the bladder, and adverse effect profile. Our objective was to describe the costs and explore the use patterns of specific OAB agents in the Wisconsin Medicaid population. Methods: The claims data used for analysis included all Wisconsin Medicaid paid prescription claims data from January 1, 2002 to December 31, 2002. These data were obtained directly from the Centers for Medicare & Medicaid Services Web site. National Drug Codes were used to extract use data for tolterodine immediate and extended-release, oxybutynin immediate and extended-release, and flavoxate. Descriptive analysis of claims included calculation of total expenditures, number of claims reimbursed, and mean cost per claim across products and formulations. Results: In 2002, the Wisconsin Medicaid program reimbursed for OAB agent claims totaling $3,423,458.30, representing 55,864 claims. Within the OAB category, oxybutynin extended-release (14,899 claims), tolterodine extended-release (14,852 claims) and oxybutynin immediate-release (13,343 claims) represented the most frequently used products. Extended-release products constituted 47% of total prescription claims expenditures in 2002. Cost per claim values within the extendedrelease OAB agents were $77.67 for tolterodine and $82.44 for oxybutynin. Conclusions: In the Wisconsin Medicaid population, the top three most frequently used OAB agents in 2002 were oxybutynin (extended-release), tolterodine (extended-release), and oxybutynin (immediate-release). Among extended-release OAB products tolterodine exhibits a more favorable cost per claim ratio than did oxybutynin. 28—ADHERENCE MEASURES OF PSY- CHOSTIMULANTS USED IN THE TREAT- MENT OF ATTENTION-DEFICIT/HYPERAC- TIVITY DISORDER IN CHILDREN AND ADO- LESCENTS. Sanchez R. E-mail: rjsrph@yahoo.com Objective: The purpose of this study was to examine adherence measures of various psychostimulants in school-aged children with attentiondeficit/hyperactivity disorder (ADHD). Methods: Paid prescription claims from May 1, 2001 to May 31, 2002 were extracted from the Texas Medicaid prescription claims database. Adherence measures included persistence, medication possession ratio (MPR), and consistence. Adherence was evaluated based on drug, age, and gender. Results: Subjects initiated on Concerta performed better on all three adherence measures. Mean persistence, MPR, and consistence were 0.50, 0.76, and 0.81, respectively. Subjects aged 5–9 years exhibited better persistence and consistence than did those aged 10–14 years and 15–18 years. Mean persistence and consistence were 0.45 and 0.78, respectively, for subjects aged 5–9 years. No gender-related adherence differences were found among the groups. Conclusions: Separation between Concerta and the other stimulants was statically significant. However, this significance may not be clinically meaningful. Younger children tended to perform better on adherence measures than older children. As medical advances continue to improve, physicians, pharmacists, managed care organizations, and other health care-related workers should develop strategies to identify and improve adherence to medications. Further investigation into the clinical relevance of these findings should be explored. 29—AN EVALUATION OF THE MANAGE- MENT OF HYPERLIPIDEMIA IN COMMUNI- TY BASED OUTPATIENT CLINICS WITH A CENTRALLY BASED CLINICAL PHARMA- CIST (“VIRTUAL CLINICAL PHARMA- CIST”). Evanko T, Jones W, Southern Arizona VA Health Care System. E-mail: tara.evanko@med.va.gov Objective: The objective of this project was to evaluate the impact of a clinical pharmacist in a hyperlipidemia disease state management program using telephone contact and follow-up for a Veterans Affairs (VA) Community Based Outpatient Clinics (CBOCs). Methods: This was a prospective open study of patients with hyperlipidemia approved by the local 232 Journal of the American Pharmacists Association www.japha.org March/April 2004 Vol. 44, No. 2 Downloaded From: http://japha.org/ on 01/25/2014
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