Algorithms used to identify ventricular arrhythmias and sudden cardiac death in retrospective studies: a systematic literature review.

Drug-induced QT interval prolongation may increase the risk of sudden cardiac death or ventricular arrhythmias (SCD/VA), and therefore affects the safety profile of medications. Administrative databases can be used to inform pharmacoepidemiologic drug safety studies for such rare events. In order to compare event rates between studies, validated operational definitions of these events are needed. We conducted a systematic literature review in PubMed to identify algorithms for SCD/VA. Twenty-two studies were included in the review. Fifteen (68%) studies evaluated International Classification of Diseases, 9th revision (ICD-9) based medical data, of which six utilized a common, validated operational definition. This algorithm was based on principal hospitalization discharge diagnosis or first-listed emergency department visit diagnosis, with an average positive predictive value (PPV) of 85%. Four studies evaluated ICD-9 based death data, of which three utilized a common algorithm with an average PPV of 88%. Further validation of ICD, 10th revision algorithms are needed. In conclusion, we identified a validated algorithm for SCD/VA in medical data, as well as in death data. As such, to ensure comparability between new research and the existing literature, pharmacoepidemiologic research in this area should utilize common, validated algorithms, such as the ones identified in our review, to operationally define these events.

Implications of recent controlled substance policy initiatives.

Legislative and regulatory efforts to address controlled substance diversion and overuse of narcotics are affecting prescription drug utilization and patient care. These initiatives can influence formulary drug selection, prior authorization procedures, and drug utilization strategies.

Risk of hepatotoxicity associated with fluoroquinolones: a national case-control safety study.

PURPOSE: Results of a pharmacoepidemiologic evaluation of fluoroquinolone-associated hepatotoxicity using national hospital admissions data on Veterans Affairs (VA) patients are reported. METHODS: In a retrospective case-control study, all adults with a primary diagnosis of hepatotoxicity on admission to a VA facility during a 6.5-year period (January 2002-June 2008) were identified. After the exclusion of patients whose records indicated known causes of hepatotoxicity or a history of liver disease, a subgroup of 7,862 patients with exposure to fluoroquinolone antibiotics in the six months prior to hospital admission were matched with nonexposed controls (n = 45,512). Conditional logistic regression was used to assess the overall and drug-specific risks of hepatotoxicity in the case group, controlling for comorbidities, concomitant use of known hepatotoxic medications, and other variables. RESULTS: After adjusting for confounders, logistic regression analysis indicated a significantly higher overall risk of hepatotoxicity development among fluoroquinolone users relative to controls (odds ratio [OR], 1.20; 95% confidence interval [CI], 1.04-1.38). Drug-specific risk analyses focused on three fluoroquinolone agents (ciprofloxacin, levofloxacin, and moxifloxacin) indicated a significant association between ciprofloxacin use and an increased risk of hepatotoxicity (OR, 1.29; 95% CI, 1.05-1.58); when considered as independent variables, levofloxacin use and moxifloxacin use were not significantly associated with hepatotoxicity risk. CONCLUSION: The findings of a national VA safety study suggested an increased hepatotoxicity risk asssociated with fluoroquinolone exposure in the study population.

The affordable care act: new features in 2013.

Among the health care changes this year: revenues to hospitals will be lower, payments to physicians will be modified, and more patients will be covered by Medicaid.

Medical marijuana and related legal aspects.

State policies vary regarding the legal use of marijuana for medicinal purposes. Pharmacists, physicians, and P&T committee members must become familiar with the laws in their states before assuming that this controlled substance can be legally prescribed or dispensed to patients.

Accountable care organizations: an improvement over HMOs?

The ACO model is considered an important achievement of health care reform legislation. However, ACOs might not be able to deliver on their promises in part because of the slowly recovering economy. It is also not clear how much money will be saved, and not all hospitals plan to participate.

Understanding insurance coverage in the senior market: reimbursement and emerging trends.

Currently, Medicare Part D is the primary payer of pharmaceuticals and driver of formulary selection for most seniors, regardless of their care setting. This primer examines key issues in reimbursement for geriatric care from a historical perspective and how it has affected health care professionals in their clinical and distributive functions. Discussion on how reimbursement trends evolved for older adult patients across care settings such as nursing facilities, assisted living, hospice, and home health are included. Additionally, this primer identifies what is changing across the different care settings, the complexities of medication coverage today, and current trends that may have significant impact on medication cost in the near future if the Affordable Care Act is implemented as currently written. Finally, the primer identifies legislative and regulatory initiatives and reimbursement trends that will continue to pose a challenge in the coming years as Congress and the president address the number of individuals covered by publicly funded programs. This challenge will be amplified in part by a growing biotechnology pharmaceutical pipeline and a rapidly increasing genomics industry.

An innovative approach to pharmacy management in a state correctional system.

Numerous models are employed for medication distribution and pharmacy services management in correctional facilities. Since 2003, the University of Rhode Island College of Pharmacy and the Rhode Island Department of Corrections (RIDOC) have collaborated on a pharmacy management program designed to better integrate medical care, improve medication utilization, and reduce pharmaceuticals costs. The program introduced staff education, waste-reduction strategies, treatment protocols, and a responsive formulary system. RIDOC pharmaceutical expenditures grew at a rate of approximately 1.5% Per Inmate Per Year from 2003 to 2009, considerably below the annual pharmaceutical inflation rate. Analyses of projected and actual drug spending indicate that RIDOC benefited from savings of almost $5 million during this period. This innovative approach to pharmacy management addressed many pharmaceutical care issues that had challenged RIDOC while providing educational opportunities for doctor of pharmacy students in this practice setting.

[Isokinetic profile of knee flexors and extensors in a population of rugby players]. / Profil isocinétique des muscles fléchisseurs et extenseurs du genou chez une population de rugbymen.

OBJECTIVE: We aimed to assess the isokinetic profile of the flexor and extensor muscles of the knee within a population of rugby players. METHODS AND POPULATION: This was a descriptive study. The rugby players underwent bilateral isokinetic assessment of knee flexion and extension on a CON-TREX MJ isokinetic dynamometer functioning at four angular frequencies - 90, 120, 180 and 240 degrees/s - in a concentric manner. The isokinetic parameters were peak torque, mean power, and mean work in relation to weight and femoral bicep: quadriceps ratio. The population included 16 "Federal 1" (semi-professional) rugby players with mean age 25 years (range 20-33 years). The players were divided into two groups: "forward" players (props, hookers, second line, third line) and "back" players (scrum, inside, center, wing, tail). RESULTS: The values of the isokinetic parameters did not reveal use of a preferred limb. Consequently, peak torque and mean power were higher in forward players than back players, whereas back players showed a higher relative power throughout the isokinetic test. CONCLUSION: Among rugby players, forward and back players showed differences in several isokinetic parameters. Accurate knowledge of the equilibrium between the knee's effector muscles is important for stability of the joint, to not only minimize articular accidents but also pinpoint force imbalances, thereby preventing muscular lesions during the sports season.

Nonadherence as a predictor of antidiabetic drug therapy intensification (augmentation).

PURPOSE: To determine if nonadherence with antidiabetic drug therapy is predictive of subsequent antidiabetic drug therapy intensification. METHODS: We conducted a retrospective cohort study examining retail pharmacy dispensings of sulfonylureas or metformin to 1067 patients having diabetes. Patients that did not receive a sufficient quantity of medication to cover at least 80% of days during the evaluation period were classified as nonadherent. Outcomes identified were increase in the dose of antidiabetic medication utilized, the addition of a second antidiabetic agent to the regimen or either. RESULTS: Among users of sulfonylurea monotherapy, those classified as nonadherent were 45% more likely to intensify therapy in subsequent months as compared with those classified as adherent (age-adjusted odds ratio (OR) 1.45; 95% confidence interval (CI) 1.06-2.00). This finding was largely driven by observed increases in dosage, which were more likely among patients classified as nonadherent (age-adjusted OR 1.48, 95%CI 1.07-2.05). Nonadherence was not found to be predictive of the subsequent addition of a second antidiabetic agent (OR 1.02; 95%CI 0.64-1.63). Overall findings were similar for the smaller sample of patients receiving metformin monotherapy, though observed differences did not achieve statistical significance. CONCLUSIONS: Patients who were poorly adherent to oral antidiabetic drug therapy more frequently experienced an increase in the dose of medication prescribed, as compared to patients that were classified as adherent. This finding underscores the need for prescribers to consider nonadherence as a root cause when patients fail to achieve therapeutic goals.

Use of potentially inappropriate drugs in nursing homes.

STUDY OBJECTIVES: To examine patterns and determine predictors of inappropriate drug use in nursing homes. DESIGN: Retrospective study. SETTING: One thousand four hundred ninety-two nursing homes in five states. PATIENTS: A total of 44,562 residents admitted to nursing homes over 1 year. METHODS: Frequency of discontinuation and initiation of potentially inappropriate drugs over the first 90 days after admission to a nursing home was calculated. Data were collected using the minimum data set. RESULTS: On admission, 33% of residents were receiving at least one potentially inappropriate drug. After 90 days, the drug was discontinued in 16% of these residents. Of those not receiving a potentially inappropriate drug on admission, one was begun in 18%. Demographic factors and number of drugs taken by patients were associated with the use of potentially inappropriate drugs. CONCLUSIONS; Use of potentially inappropriate drugs was prevalent on admission and at 90 days after admission. Discontinuation was highest among patients with conditions for which potentially safer therapeutic alternatives existed.

Patient compliance and blood pressure control on a nuclear-powered aircraft carrier: impact of a pharmacy officer.

The impact of a pharmacy officer on patient compliance and blood pressure control on a deployed nuclear-powered aircraft carrier for a 2-week at-sea period was evaluated. Before any counseling by a pharmacy officer, 43 crewmembers on chronic medications anonymously completed a compliance questionnaire. The pharmacy officer then counseled these crewmembers. A follow-up compliance questionnaire was completed 2 weeks later. After counseling, compliance had increased 58% (p < 0.0001) from compliance measured before counseling. The pharmacy officer also initiated therapeutic interventions. Among 26 crewmembers diagnosed as hypertensive, preintervention blood pressure (BP) measurements were obtained. Ten to 14 days after the initial BP measurement, BP was remeasured. After intervention, 31% (p < 0.02) more crewmembers were at BP goal compared with before intervention. A pharmacy officer, working closely with a medical officer, improved patient compliance and blood pressure control. One problem identified was that these warships require computer software that can prospectively identify drug-drug interactions.

Cocaine use and HIV disease progression among heterosexuals.

Evidence derived fromin vitro experiments would suggest that cocaine exposure may hasten the progression of HIV disease among infected individuals. Epidemiologic support for this association is equivocal at best. We examined the relationship between cocaine use and decline in CD4 cell counts over a 6-month period in a cohort of 81 heterosexually active men and women who were infected with HIV. Overall, cocaine users were 1.4 times (90% CI=1.0-2.1) more likely to experience a decline in CD4 count than were non-cocaine users. Cocaine users with a baseline CD4 count of greater than 500 cells/mm(3) were at 1.6 times (90% CI=1.2-2.3) greater risk for a CD4 decline than non-cocaine users at this baseline CD4 level. Concurrent treatment with an antiretroviral agent [AZT] modified the strength of this association, as evidenced by a cumulative incidence ratio (CIR) of 0.4 (90% CI=0.1-1.3) among AZT users and a CIR=2.2 (90% CI=1.5-3.2) among those not undergoing AZT treatment. The results of this study raise concerns about the negative effects of cocaine on people living with HIV infection, particularly those not receiving antiretroviral therapy who entered our study with a relatively intact immune system.

Screening for peripheral arterial disease.

Peripheral arterial disease (PAD) is an age-dependent condition that limits ambulation and compromises quality of life in an estimated two million Americans. Early detection and treatment is essential for minimizing the signs and symptoms of PAD. Using a methodology developed by the National Council on the Aging, a noninvasive screening program was conducted for this disease in a population of 1,092 elderly ambulatory Rhode Island residents. Possible PAD was detected in 17.7% of the subjects, while 42% were identified as being at high risk for the disease.

Regulatory environment and psychotropic use in board-and-care facilities: results of a 10-state study.

BACKGROUND: Largely unsupervised administration of drugs and the potential for overuse of psychotropic agents in residential care facilities have emerged as major public policy concerns. In a large multistate study, we examined patterns of psychotropic prescription and use by facility licensure status and the extensiveness of state regulations. METHODS: Descriptive analyses were based on a sample of 2,949 residents from 493 board-and-care facilities in 10 states, drawn via a complex, multistage sampling design. States were purposively selected based on the stringency of their board-and-care regulatory system, and samples of facilities were drawn, stratified by licensure status and home size. Residents were randomly selected within the sampled facilities. Weighted analyses were performed with Software for Survey Data Analysis (SUDAAN), accounting for the complex sampling design. RESULTS: Approximately 43% of the residents were prescribed and 41% used at least one psychotropic agent, primarily on a routinely scheduled basis. Antipsychotics were prescribed to 22% and used by 21%; antidepressants were prescribed to 17% and taken by 16%; antimanic agents were prescribed to and used by 4%; and anxiolytics, sedatives, or hypnotics were prescribed to 17% and used by 14%. Among psychotropic users, over 50% had not had mental health services in the prior year; 25% had no psychiatric history. Among licensed facilities, prescription and use of psychotropics, particularly antipsychotics, was significantly higher among residents of homes located in states with limited regulatory systems. CONCLUSIONS: Results revealed high rates of psychotropic prescription and use, and not inconsequential levels of polypharmacy - within and across therapeutic classes - among board-and-care facility residents. Frequently, psychotropics were not used as an adjunct to alternative treatments, and were not associated with a psychiatric history. Extent of psychotropic use was related to the regulatory environment, suggesting that more extensive regulations and monitoring may reduce psychoactive drug use in board-and-care facilities, and more adequately ensure the appropriateness of such treatment.

Psychotropic use among older residents of board and care facilities.

OBJECTIVE: To describe patterns of psychotropic use as well as clinically relevant and concurrent nonpsychotropic use among older residents of board and care facilities in 10 states. METHODS: Weighted use rates were based on data from a sample of 2054 residents aged 65 and older from 410 facilities in 10 states, drawn via a complex, multistage sampling design. Data, including drug name, use frequency, and PRN use, were collected on all drugs taken by the resident during a 7-day period. During face-to-face interviews with residents and/or proxies, data were also collected on resident characteristics. SUBJECTS: The majority of subjects were female, white, and widowed. Average age was 82 years. Approximately 25% had a current mental or emotional condition, and 8% had been hospitalized for a psychiatric condition during the year before admission. More than half needed help with at least one activity of daily living. Forty percent had moderate or severe cognitive impairment, and 18% had received mental health care during the previous year. ANALYSES: Weighted descriptive analyses were performed with Software for Survey Data Analysis (SUDAAN), which accounts for the complex, multistage sampling design. RESULTS: Approximately 35% of the older residents used at least one psychoactive agent, with 30% of psychotropic users receiving two to four different psychotropic medications. Use rates decline with age, for psychotropics overall and for therapeutic classes. Results revealed potentially problematic polypharmacy in relation to drug duplication within therapeutic classes, use of multiple psychotropics across classes, and concurrent nonpsychotropic use. CONCLUSIONS: Compared with community-dwelling older adults, this study revealed high psychotropic use rates among older board and care facility residents. Overall, our results suggest that serious consideration be given to the apparent need for systematic drug utilization review, a potentially useful program that is mandated in other settings.

Cocaine use and heterosexual exposure to human immunodeficiency virus.

We examined the relation between recent cocaine use and heterosexual exposure to human immunodeficiency virus (HIV). Five hundred nineteen heterosexually active participants in the New England Behavioral Health Study, an HIV testing and counseling program, provided information for this study. The outcome measure included behaviors that increased the risk for exposure to HIV via contact with infected genital secretions. Nearly one-third (31.8%) of participants reported use of cocaine during the year before study entry. These individuals were 1.3 times [90% confidence interval (CI) = 1.1-1.7] more likely to risk HIV exposure than people not using cocaine during this period, with evidence of a dose-dependent relation among HIV-positive cocaine users. HIV-positive crack users were at 1.9 times greater risk (90% CI = 1.2-2.9) for HIV risk-taking behavior than those who did not use crack. The effect of cocaine was present even among those individuals without other injection drug use.

Cost-effectiveness study of nitrate therapy using a decision analysis methodology.

The cost-assessment technology of decision analysis was applied to isosorbide dinitrate (ISDN), the standard therapy for angina; isosorbide mononitrate (ISMO), approved mid-1992; and nitroglycerin patches to measure the effect of economics on clinical practice and administrative choices. The evaluation was conducted to illustrate the utility of this method for decision makers in various sectors of the health care system, including physicians, pharmacy benefit administrators, formulary committees, and manufacturers. Findings indicate that despite a higher unit cost for ISMO, total anticipated treatment costs with this new long-acting nitrate are lower than those associated with ISDN (28%) and nitroglycerin patch (16%) therapy in patients with stable angina, and ISMO requires less dosing titration and is associated with fewer tolerance effects.

Entangled epidemics: cocaine use and HIV disease.

Over the past decade, two epidemics have had a severe impact on public health in this country. These health problems involve cocaine abuse and AIDS (or HIV disease). The processes of these two conditions are clearly not independent of each other and may be quite complex. Understanding of this relationship has been hampered by a myriad of social, biological and behavioral variables that are entangled with the basic cocaine-HIV association. This article presents a paradigm for discussion of the interaction between cocaine exposure and HIV disease based on three mechanisms: the relationship between cocaine exposure and increased opportunity for HIV exposure, the direct role that cocaine plays in altering susceptibility to HIV infection, and the influence that cocaine use has on the progression of HIV disease. The goal of this structured approach is to enhance conceptual understanding of the cocaine-HIV relationship while recognizing the complexity of the issue and the limitations of current research efforts. This model will serve as a framework for the discussion of implications for future research, clinical practice, and public policy.