Safety and effectiveness of varenicline in a veteran population with a high prevalence of mental illness.

BACKGROUND: Varenicline is a selective nicotinic receptor partial agonist used to aid in the process of smoking cessation. Research on varenicline's approval for marketing demonstrated that after 12 weeks of treatment, at least 44% of patients successfully quit smoking and, on average, 13% of individuals discontinued therapy due to an adverse drug event (ADE). Growing postmarketing data linked varenicline to an increase in neuropsychiatric symptoms. OBJECTIVE: To evaluate the safety profile, specifically psychiatric symptoms, and effectiveness of varenicline in a veteran population and to determine whether there is an association among specific baseline demographics and success rate. METHODS: The study was a retrospective review of a prospective performance measure involving veterans initiated on varenicline. Patients were contacted via telephone throughout treatment and at week 12 for effectiveness follow-up. Smoking history was obtained and medication counseling was provided. The primary endpoint was tobacco cessation between weeks 9 and 12 of therapy. Varenicline's safety profile and discontinuation rates due to ADEs were also analyzed. RESULTS: Of the 50 patients included in the study, 30% (n = 15) successfully quit smoking and 70% (n = 35) failed therapy (lack of effectiveness, n = 22; intolerability, n = 13). Prevalence of underlying mental illness in the success group (4/15; 27%) versus failure group (20/35; 57%) was statistically significant (p < 0.001). All patients who discontinued therapy due to an increase in mood and behavioral changes (n = 4) had an underlying psychiatric illness. The study results demonstrate a lower success rate and a higher incidence of discontinuation due to an ADE in our veteran population compared with premarketing data. An inverse association was shown between psychiatric disorders and success. CONCLUSIONS: Cautious treatment initiation and close monitoring of veterans initiated on varenicline are warranted. Furthermore, the results from this study demonstrate the need for prospective effectiveness trials to determine the clinical significance of the results.

Establishment and outcomes of a model primary care pharmacy service system.

PURPOSE: The establishment and outcomes of a model primary care pharmacy service system are described. SUMMARY: A primary care pharmacy practice model was established at a government health care facility in March 1996. The original objective was to establish a primary pharmacy practice model that would demonstrate improved patient outcomes and maximize the pharmacist's contributions to drug therapy. Since its inception, many improvements have been realized and supported by advanced computer and automated systems, expanded disease state management practices, and unique practitioner and administrative support. Many outcomes studies have been performed on the pharmacist-initiated and -managed clinics, leading to improved patient care and conveying the quality-conscious and cost-effective role pharmacists can play as independent practitioners in this environment. These activities demonstrate cutting-edge leadership in health-system pharmacy. Redesign has been used to improve consistent access to a medication expert and has significantly improved the quality of patient care while easing physicians' workload without increasing health care costs. CONCLUSION: A system using pharmacists as independent practitioners to promote primary care has achieved high-quality and cost-effective patient care.