The 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (also known as statins) are associated with elevated transaminase levels in 1-3% of patients. Therapy with these drugs requires monitoring of alanine aminotransferase (ALT) levels because animal studies and premarketing clinical trials showed signs of hepatotoxicity that were primarily minor elevations of ALT. Nevertheless, postmarketing experience suggests that hepatotoxicity is rare, and that elevated ALT levels are reversible with continued therapy and probably are related to cholesterol lowering. Based on the low occurrence of ALT elevations and the lack of clinical evidence of hepatotoxicity, some clinicians are calling for a change in the current practice of monitoring liver function tests. We report, however, the case of a 71-year-old woman who was receiving atorvastatin and experienced elevated transaminase levels on two occasions, and developed pruritus on rechallenge with the drug. Thus, clinicians should be aware of asymptomatic elevations in liver function tests in patients receiving atorvastatin who do not have known risk factors for liver damage.
BACKGROUND: Primary care clinical pharmacy specialists (PCCPSs) are positioned to promote effective, safe, and affordable medication use. Documentation of performed interventions is difficult because the diversity of performed interventions in a variety of disease states in some practice settings. Validation of cost-avoidance projections is also difficult because traditional projection methods have several limitations.OBJECTIVE: To (1) compare projected medication cost avoidance (MCA) to actual MCA for medication conversions related to hyperlipidemia, hypertension, depression, and chronic pain initiated by PCCPS, and (2) estimate medication discontinuation that might be attributable to serious adverse drug events (ADEs) possibly associated with medication conversions.METHODS: This was a retrospective, longitudinal study conducted in a not-for-profit, integrated health system comprising approximately 470,000 members. Using a portable documentation tool, PCCPSs recorded projected annual MCA for medication conversions in 4 disease conditions (i.e., hyper tension, dyslipidemia, depression, and chronic pain) in the 6-month period from December 1, 2003, through May 31, 2004. Actual annual MCA for these interventions for a 1-year follow-up period was calculated using integrated, electronic data from an administrative pharmacy database. Comparisons were made between projected MCA and actual MCA. Cost was defined as actual drug acquisition cost. In addition, an assessment of serious ADEs potentially related to the conversions was undertaken by reviewing electronic medical records of converted, nonpersistent patients.
H ealth care in the United States is increasingly being delivered during ambulatory care visits. 1 As new investment in health care shifts from the inpatient to outpatient setting, the role of ambulatory clinical pharmacists (CP) are expanding. While dispensing pharmacists provide clinical screening and patient education for potential drugrelated problems, CPs provide services that complement the care provided by dispensing pharmacists by directly advising and educating other health care providers and patients on appropriate pharmaceutical use and dosing.Initial involvement of CPs in the ambulatory setting occurred primarily in the primary care setting. Early studies examined the impact of CPs and reported improved outcomes with clinical pharmacy management of care on patient compliance, [2][3][4][5][6] diabetes, 7 patient-specific drug information, 8 and treatment of infections.9 Systematic reviews of CP involvement in ambulatory settings note that while the quality of research (e.g., weak methodology, small sample sizes) is limited, the participation of CPs in health care has resulted in positive cost-effective care.10-12 A 2010 Cochrane review summarizing randomized controlled studies of CP involvement noted that most of the studies meeting inclusion took place in a primary care or community pharmacy setting rather than a specialties setting. 12CP involvement in ambulatory specialty areas has expanded into a broader array of disease states. Reports noting CP involvement in psychiatry practices were first published in the 1970s. 13,14 Currently, settings with CP involvement in specialty clinics include primarily health maintenance organizations, teaching institutions, and Veterans Affairs (VA) health systems.15 Other nonfee-for-service settings that may have specialty CP involvement include community clinics and other non-VA government health care systems. Systematic reviews summarizing the roles and/or impact of CP involvement in various specialty areas have been published. These areas include mental health, [16][17] 25 Knapp et al.'s (2005) 2004 survey of 233 ambulatory sites with CP involvement reported that the most common area of specialty CP involvement was oncology (28% of participating sites).15 Less than 10% of participating sites had CP involvement in neurology, heart failure, or psychiatry management, while involvement in other medical specialties was not reported by most participating sites.15 Accordingly, C O M M E N TA R YCP involvement in many specialties in the ambulatory setting has not been described in the literature, and little research on the clinical and economic outcomes of CP involvement has been conducted in specialty settings. [16][17][18]
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