Kathryn A. Phillips

Dispensing limits, which ration prescriptions to 30-day supplies when filled at community pharmacies, is a strategy commonly used to control prescription drug costs. Yet, little is known about drug dispensing patterns. Prescription dispensing patterns may have important influences on adherence, therapeutic and preventive health outcomes, and costs. This study examined dispensing patterns for five drug classes commonly prescribed for chronic conditions.

Cost-effectiveness analysis is a widely used tool to assess the value of healthcare interventions. Our objective was to conduct a systematic review of the literature on the cost effectiveness of pharmacogenomic interventions. We found 11 studies that met our inclusion criteria. The most commonly examined disease was deep vein thrombosis (n=4), followed by cancer (n=3) and viral infections (n=3); the most frequently examined mutation was factor V Leiden (n=5); and the majority of the mutations examined were inherited mutations (n=7), although several studies looked at acquired (tumor or viral) mutations (n=4). The majority of the studies reported a favorable cost-effectiveness ratio for the pharmacogenomic-based strategy (n=7), while two studies reported that the pharmacogenomic-based strategy was not cost effective and two were equivocal. We conclude that there have been few evaluations of the economic costs and benefits of pharmacogenomic interventions and they have covered a limited number of conditions. Further analyses that can be used to guide the use of pharmacogenomics in clinical practice and in developing health policies are urgently needed.

To determine the potential impact of genetic testing and pharmacogenomics on healthcare delivery and costs. Literature review. We examined 3 examples: (1) BRCA1/2 testing for breast cancer risk, (2) HER2/neu overexpression testing to guide drug treatment in women with breast cancer, and (3) CYP2C9 testing before the use of the anticoagulant warfarin. We discussed each genetic testing example from the perspective of the patient, provider, insurer, industry, government, and society. The expanded use of genetic information offers many potential clinical benefits, but also many economic challenges. One of those challenges will be managing the impact of genetic testing on healthcare delivery and costs. Systematic, evidence-based technology assessments and economic evaluations will have to be used to guide the incorporation of genomics into clinical practice. More research also will be needed to assess patient preferences and willingness to pay for genomic technologies; how providers can assess and use genomic technologies; and how the industry, insurers, and government can best balance the relevant costs and benefits.

Methods of economic evaluation, especially cost-effectiveness analysis and cost-benefit analysis, are widely used to examine new healthcare technologies. However, few economic evaluations of pharmacogenomics have been conducted, and pharmacogenomic researchers may be unfamiliar with how to review or conduct these analyses. This review provides an overview of the methods of economic evaluation and examples of where they have been applied to pharmacogenomics. We discuss the steps in conducting a cost-effectiveness or cost-benefit analysis, demonstrating these steps using specific examples from the pharmacogenomics literature.

In conjoint analysis (CA) studies, choosing between scenarios with multiple health attributes may be demanding for respondents. This study examined whether simplifying the choice task in CA designs, by using a design with more overlap of attribute levels, provides advantages over standard minimal‐overlap methods. Two experimental conditions, minimal and increased‐overlap discrete choice CA designs, were administered to 353 respondents as part of a larger HIV testing preference survey. In the minimal‐overlap survey, all six attribute levels were allowed to vary. In the increased‐overlap survey, an average of two attribute levels were the same between each set of scenarios. We hypothesized that the increased‐overlap design would reduce cognitive burden, while minimally impacting statistical efficiency. We did not find any significant improvement in consistency, willingness to trade, perceived difficulty, fatigue, or efficiency, although several results were in the expected direction. However, evidence suggested that there were differences in stated preferences. The results increase our understanding of how respondents answer CA questions and how to improve future surveys. Copyright © 2003 John Wiley & Sons, Ltd.

We review two new HIV counseling and testing guidelines by the U.S. Centers for Disease Control and Prevention. The guidelines, which address the general population and pregnant women, reflect an important shift in the goals and methods of counseling and testing that has widespread implications. The guidelines' defining characteristic is the greater emphasis on increasing the numbers of people knowing their HIV status while maintaining the historical focus on extensive pretest counseling and consent procedures. We discuss the policy and practice implications by evaluating five factors: 1) Will the guidelines be adopted? 2) Will at-risk and infected individuals be identified for counseling and testing? 3) Will health care providers offer counseling and testing and patients accept counseling and testing, obtain their test results, seek treatment, and change risky behaviors? 4) Will the guidelines be relatively cost-effective? 5) Will the guidelines be compatible with ethical standards?

Review from JAMA — Potential Role of Pharmacogenomics in Reducing Adverse Drug Reactions — A Systematic Review — ContextAdverse drug reactions are a significant cause of morbidity and mortality. Although many adverse drug reactions are considered nonpreventable, recent developments suggest these reactions may be avoided through individualization of drug therapies based on genetic information, an application known as pharmacogenomics.ObjectiveTo evaluate the potential role of pharmacogenomics in reducing the incidence of adverse drug reactions.Data SourcesMEDLINE English-language only searches for adverse drug reaction studies published between January 1995 and June 2000 and review articles of variant alleles of drug-metabolizing enzymes published between January 1997 and August 2000. We also used online resources, texts, and expert opinion.Study SelectionDetailed inclusion criteria were used to select studies. We included 18 of 333 adverse drug reaction studies and 22 of 61 variant allele review articles.Data ExtractionAll the investigators reviewed and coded articles using standardized abstracting forms.Data SynthesisWe identified 27 drugs frequently cited in adverse drug reaction studies. Among these drugs, 59% are metabolized by at least 1 enzyme with a variant allele known to cause poor metabolism. Conversely, only 7% to 22% of randomly selected drugs are known to be metabolized by enzymes with this genetic variability (range, P = .006-P<.001).ConclusionsOur results suggest that drug therapy based on individuals' genetic makeups may result in a clinically important reduction in adverse outcomes. Our findings serve as a foundation for further research on how pharmacogenomics can reduce the incidence of adverse reactions and on the resulting clinical, societal, and economic implications.