Therapeutic Inertia in Prescribing Biologics for Patients with Moderate-to-Severe Asthma: Workshop Summary.

Moderate-to-severe asthma represents about a quarter of the nearly 10% of Americans diagnosed with asthma. Many patients with moderate-to-severe asthma have uncontrolled symptoms that lead to exacerbations requiring oral corticosteroids. There are many factors contributing to poor asthma control, including poor adherence to prescribed therapies, the under-prescribing of biologics and therapeutic inertia. We convened an eight-member panel from fields of primary care, pulmonology, immunology, health services and clinical research, behavioral science and pharmaceutical medical affairs, with the goal of identifying contributing factors and solutions to therapeutic inertia with asthma biologics. We used the Capability, Opportunity, and Motivation (COM-B) model to classify patient and provider behavior towards therapeutic inertia. The model incorporates existing behavior theories and is driven by the interaction of capability, opportunity, and motivation. We used a Delphi method to identify and develop six primary solutions: 1) integration of patient-centered outcomes into asthma management practice; 2) provider education about asthma treatment; 3) moderate-to-severe asthma care delivery redesign; 4) harmonized, evidence-based protocol for the management of moderate-to-severe asthma; 5) designated coordinator approach for optimal asthma management; and 6) a case coordination digital support tool. Integration of patient-centered outcomes into asthma management practice and provider education were identified as having the highest potential to impact therapeutic and clinical inertia. The COM-B model is effective in identifying improvement within therapeutic inertia targeting the capabilities, opportunities, and motivations of patients, providers, and payer systems.

Alvimopan: an oral, peripherally acting, mu-opioid receptor antagonist for the treatment of opioid-induced bowel dysfunction--a 21-day treatment-randomized clinical trial.

Alvimopan has been shown to reverse the inhibitory effect of opioids on gastrointestinal transit without affecting analgesia. We evaluated oral alvimopan, 0.5 or 1 mg, versus placebo, once daily for 21 days, in 168 patients with opioid-induced bowel dysfunction (OBD) who were receiving chronic opioid therapy (minimum, 1 month) for nonmalignant pain (n = 148) or opioid dependence (n = 20). The primary outcome was the proportion of patients having at least one bowel movement (BM) within 8 hours of study drug on each day during the 21-day treatment period. Averaged over the 21-day treatment period, 54%, 43%, and 29% of patients had a BM within 8 hours after alvimopan 1 mg, 0.5 mg, or placebo, respectively (P < .001). Secondary outcomes of median times to first BM were 3, 7, and 21 hours after initial doses of 1 mg, 0.5 mg, and placebo, respectively (P < .001; 1 mg vs placebo). Weekly BMs and overall patient satisfaction were increased after the 1-mg dose (P < .001 at weeks 1 and 2 vs placebo, and P = .046, respectively). Treatment-emergent adverse events were primarily bowel-related, occurred during the first week of treatment, and were of mild to moderate severity. Alvimopan was generally well tolerated and did not antagonize opioid analgesia. Patients treated with chronic opioid therapy often experience opioid-induced bowel dysfunction as a result of undesirable effects on peripheral opioid receptors located in the gastrointestinal tract. Alvimopan, a novel peripheral opioid mu-receptor antagonist, has demonstrated significant efficacy for the management of opioid-induced bowel dysfunction without compromise of centrally mediated opioid-induced analgesia.

A smoking-cessation program consisting of extensive counseling, pharmacotherapy, and office spirometry: results of a pilot project in a Veterans Administration Medical Center.

STUDY OBJECTIVE: To describe the 1-year outcomes of a Veterans Administration smoking-cessation program that demonstrates a standard of care comprising extensive counseling, pharmacotherapy, and office spirometry. DESIGN: Prospective one-group pretest-posttest, with an intervention of state-of-the-art practice in smoking cessation. SETTING: Outpatient clinic in a Veterans Administration Medical Center (VAMC). PATIENTS: Two hundred fifty-two veterans receiving health care at the VAMC. MEASUREMENTS AND MAIN RESULTS: The primary outcome measured was the 1-year cessation rate of smokers. Demographic and clinical covariates also were collected. Of the 252 patients who enrolled in the program, 120 never quit smoking for even 1 day. Of the remaining 132 patients, 32 (24%) achieved long-term (1 yr) cessation. The number of visits to the clinic and the number of methods used during the attempt to quit were the only variables significantly associated with long-term smoking cessation (p<0.0001 for each). CONCLUSION: The availability of a standard-of-practice clinic for smoking cessation within a primary care clinic can help patients who have a desire to quit. A combination of intensive counseling, pharmacotherapy, and office spirometry helped patients in a Veterans Administration population to achieve long-term smoking cessation.

Modeling the cost-effectiveness of a smoking-cessation program in a community pharmacy practice.

OBJECTIVES: To describe some of the costs of providing a smoking-cessation program in a community pharmacy practice, and to model the program's cost-effectiveness compared with that of a self-directed quit attempt. DESIGN AND SETTING: Data used were based primarily on results from a pharmacist-directed smoking-cessation program in a community pharmacy chain practice that achieved continuous abstinence for at least 1 year in 25% of patients. Baseline assumptions were formulated from a MEDLINE literature review and were varied in the sensitivity analysis. Overall costs were based on program costs and retail cost of the selected cessation method (cold turkey, nicotine patch, nicotine gum, or bupropion). PATIENTS: Forty-eight patients, more than two thirds of whom were women, aged 21-70 years, who had tried at least once to quit smoking. MEASUREMENTS AND MAIN RESULTS: Incremental cost-effectiveness was measured in terms of cost/successful quit attempt based on the payer's perspective. Cost/life-year saved and cost/quality-adjusted life-year saved also were calculated for the societal perspective. Incremental cost for an additional patient to quit smoking using the pharmacist-directed program alternatives versus a self-directed quit attempt was $236 for the cold turkey method, $936 for nicotine patch, $1232 for nicotine gum, and $1150 for bupropion. Depending on the smoker's age at the time of cessation, the incremental discounted cost-effectiveness was $720-1418/life-year saved. CONCLUSION: This analysis demonstrates that a pharmacist-directed cessation program is a cost-effective alternative to a self-directed quit attempt with respect to payers and society. Additional analyses conducted in community pharmacy practice are necessary to corroborate our results.

Results of a smoking cessation clinic in community pharmacy practice.

OBJECTIVES: To describe and assess the effectiveness of a smoking cessation clinic. DESIGN: Single group, unblinded study. SETTING: Seven chain (mass-merchandise) community pharmacies in Virginia. PARTICIPANTS: Forty-eight patients who were smokers when admitted to the study. INTERVENTIONS: Fifteen community chain pharmacists were trained using a smoking cessation training manual developed at the Virginia Commonwealth University School of Pharmacy. From April 1, 1997, through December 31, 1999, interested patients met individually with a study pharmacist during scheduled clinic times in semiprivate counseling areas. A patient chart was maintained at the site and updated after each visit. The first 30 patients completed a questionnaire after the third visit to the smoking cessation clinic to assess satisfaction with pharmacists and the overall program. MAIN OUTCOME MEASURE: Rate of long-term smoking cessation. RESULTS: Of the 48 patients, 12 (25.0%) abstained from smoking cigarettes for 12 months or more beyond their predetermined quit dates. Abstinence rates for 1, 3, and 6 months were 43.8%, 31.3%, and 25.0%, respectively. Women were nearly five times more successful in attaining long-term abstinence than were men (33.3% versus 6.7%; P= .047). No significant differences were observed in cessation rates related to age, number of cigarettes smoked per day, level of nicotine dependence, number of previous quit attempts, or method of cessation. Increased appetite and weight gain were the most frequently reported withdrawal symptoms (16.7% of patients). Patients expressed satisfaction with the pharmacists and the smoking cessation program. CONCLUSION: Compared with other types of previously reported interventions, a community pharmacist-managed smoking cessation clinic achieved greater long-term smoking cessation rates.

Development and implementation of a smoking cessation clinic in community pharmacy practice.

OBJECTIVE: To describe a pharmacist-operated program to help people stop smoking. SETTING: Community chain (mass-merchandise) pharmacy practice sites in Virginia. PARTICIPANTS: Faculty at the Virginia Commonwealth University School of Pharmacy (VCU) and 15 practicing pharmacists. PRACTICE DESCRIPTION: Smoking cessation clinics within the pharmacy departments of seven Target stores. PRACTICE INNOVATION: With input from the practicing pharmacists and using the most current strategies reported in the literature, faculty at VCU developed a training manual for smoking cessation counseling. This manual was used to facilitate a 4-hour training session and also served as a resource for pharmacists in the smoking cessation clinics. Pharmacists were taught about behavioral modifications, the Transtheoretical Model of Change as applied to smoking cessation, documentation, the Fagerström Test for Nicotine Dependence, smoking cessation therapies, patient counseling techniques, physical assessment skills, and how to develop an individualized action plan for smoking cessation. As pharmacists established smoking cessation clinics, issues such as workflow, continuous quality improvement, and marketing were addressed by the faculty members and practitioners. RESULTS: Using the process and tools described in this article, pharmacists successfully established and operated smoking cessation clinics. CONCLUSION: The process and materials developed for this demonstration project can serve as templates for other pharmacy faculty members and community pharmacists who wish to offer smoking cessation clinics.