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

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

Recent legislative and regulatory activity designed to address controlled substance diversion and overuse of narcotics is having a significant impact on prescription drug utilization and patient care in the United States. Although providers and patients are the focus of these new requirements, the designers and implementers of formularies and medication use protocols need to be aware of salient features of these initiatives. Formulary drug product selection, prior authorization procedures and drug utilization strategies should be reconsidered in accordance with the changes in controlled substance oversight. The primary focus of this article involves recent approaches to controlling the illegal acquisition of licit prescriptions, particularly opioid pain relievers (OPR). According to the Centers for Disease Control and Prevention (CDC), in 2008 OPRs were involved in 74% of the 20,000 fatal prescription drug overdoses in the United States. This represents an increase of over 300% since 1999 and these fatalities now exceed death by cocaine and heroin combined. [Interestingly, the death rate varied five-fold by state, largely reflecting different levels of opioid regulation and oversight. They also noted that sales of OPRs quadrupled between 2000 and 2010 and that OPR abuse cost health insurers over $72 billion annually in healthcare costs

Demographics and the Cost of Pharmaceuticals in a Private Third-Party Prescription Program

Objective: To compare variance in the cost of pharmaceuticals attributable to demographic variables with variance explained by plan characteristics, using prescription claims data within various therapeutic categories, and to examine differences in average cost of pharmaceuticals among demographic variables after controlling for covariates. Design: Retrospective, cross-sectional study. Data Collection: Data for this study were obtained from 1996 prescription claims information for the commercial population administered by a Rhode Island-based pharmacy benefit management (PBM) company. Six therapeutic categories with the highest expenditures were analyzed. Information on claims for six drug categories was extracted using database management software. Statistical analyses using multiple regression and analysis of covariance were carried out. Results: Plan characteristics outperformed demographic variables sixteenfold for all drug categories combined in explaining variance in cost of pharmaceuticals among plan enrollees. Average cost of pharmaceuticals differed among demographic variables such as age, gender, location, and place of employment after controlling for average wholesale price and days supply. Conclusions: The results obtained in this study have practical significance in the determination of capitation rates when utilization history of prospective members is not available. In this situation, managed care organizations (MCOs) or PBMs may have to set capitation rates based solely on eligibility data. Significant differences in average drug costs among the members based on place of employment suggest that benefit managers should consider differentiating capitation rates according to their clients\u27 businesses. Finally, the data from this study indicated that commercial members residing in Tennessee had the lowest average cost of pharmaceuticals among all states evaluated. The fact that one PBM manages more than 80% of the TennCare prescription program along with a significant commercial client base suggests that a spillover effect may exist

The Risk of Hepatotoxicity with Fluoroquinolones: A National Case-Control Safety Study

Purpose. Fluoroquinolones are generally considered safe and well-tolerated. However, suspected fluoroquinolone induced hepatotoxicity has been increasingly reported, but data are lacking. Thus, the objective of this study was to assess the risk of hepatotoxicity in patients using fluoroquinolones compared to non-users. Methods. National Veterans Affairs (VA) hospital admissions were assessed between January 1, 2002 and December 31, 2008. Our case-control study matched patients with a primary diagnosis of hepatotoxicity (cases) to those with myocardial infarction (controls) on admission date (matched up to 1:6). Conditional logistic regression was used to compute adjusted odds ratios (OR) and 95% confidence intervals (CI) of hepatotoxicity associated with fluoroquinolone exposure. Results. Our study included 7,862 cases and 45,512 matched controls. The majority of study patients were white (63.4%), males (97.7%), with a mean age of 61 years. After adjusting for confounders, fluoroquinolone use was significantly associated with a 20% increased risk of hepatotoxicity development (OR 1.20, 95% CI 1.04-1.38) compared to non-users. A statistically significant increased risk of hepatotoxicity was associated with ciprofloxacin use individually (OR 1.29, 95% CI 1.05-1.58), but not with levofloxacin or moxifloxacin use. Conclusion. The use of fluoroquinolones was associated with an increased risk of hepatotoxicity relative to non-users in our national VA study population

Principles and approaches to pharmacoeconomics: The perspective of higher education

The emergence of pharmacoeconomics as a vital and evolving discipline presents a unique challenge and opportunity to researchers in university settings. Although pharmacoeconomics offers the academician a fertile area for research, teaching, and service endeavors, several barriers exist which impact growth in this area. These include the ability of higher education to respond rapidly to funding opportunities, the lack of trained individuals to develop research programs, competition with other entities for these scarce human resources, problematic collaborative relationships with these same organizations, and the ability to initiate and conduct research in an unbiased arena. This paper outlines opportunities available to academic pharmacoeconomic researchers, challenges which may inhibit the maturation of this discipline, and potential strategies for addressing these challenges. © 1995, Drug Information Association. All rights reserved

Physicians\u27 knowledge and attitudes toward scheduling

Objective: To determine physicians\u27 knowledge and attitudes of medico-legal issues regarding drug scheduling. Methods: The cross sectional survey was designed to assess attitudes and mailed to 400 randomly selected physicians. Results: A total of 155 (43.8%) of the 354 delivered surveys were returned. Physicians across all groups provided consistent responses suggesting a negative attitude about scheduling, a lack of understanding of scheduling issues and a harmful impact of scheduling on their practice. Physicians who saw 20 or more patients differed significantly from the other groups in 50% (4 of the 8) questions suggesting enhanced dissatisfaction. © 2009 Informa UK Ltd

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