Platelet glycoprotein IIb/IIIa-receptor inhibitors in patients with acute coronary syndromes or undergoing percutaneous coronary interventions: a review.

BACKGROUND: Over 12.2 million Americans are affected by acute coronary syndromes (ACS) resulting from arterial thrombosis after atherosclerotic plaque rupture. The mechanism of thrombosis is based on the platelet activation pathway, facilitated by expression of the platelet glycoprotein (GP) lIb/Illa receptors. The platelet GP IIb/IIIa-receptor inhibitors represent a new class of drugs, of which abciximab, eptifibatide, and tirofiban have been approved for use in the medical management of ACS and as adjunctive therapy in percutaneous coronary interventions (PCIs). OBJECTIVE: This article reviews the results of published multicenter, randomized, placebo-controlled, double-blind trials of the efficacy and safety of platelet GP IIb/IIIa-receptor inhibitors in patients with coronary artery disease. METHODS: To identify articles for this review, a search of MEDLINE for the years 1994 through 2000 was conducted using the key words myocardial ischemia, unstable angina, angioplasty, stent, abciximab, eptifibatide, tirofiban, lamifiban, and platelet aggregation inhibitors. Relevant review articles were consulted as well as reports of clinical studies. CONCLUSIONS: Three GP IIb/IIIa-receptor inhibitors--abciximab, eptifibatide, and tirofiban-are approved by the US Food and Drug Administration as adjunctive therapy in patients undergoing PCI. Eptifibatide and tirofiban 'are also indicated for the medical management of patients with unstable angina and non-ST-segment-elevation myocardial infarction. The use of GP IIb/IIIa-receptor inhibitors as a component of management with fibrinolytic agents is under investigation. Studies comparing the efficacy of tirofiban and abciximab in patients undergoing planned PCI with intracoronary stent placement are in progress. Until data are available from long-term trials and head-to-head comparisons of these agents, it is not possible to generalize about their overall or comparative efficacy.

Identifying patient needs in the context of the medication use situation.

OBJECTIVES: (1) To identify whether differences in the likelihood of using pharmacy services exist for consumers when faced with different medication use situations; (2) to identify differences in consumers' expectations of pharmacy services according to type of pharmacy; and (3) to determine whether a relationship exists between patient demographics and the likelihood of using different pharmacy services. DESIGN: Consumers were provided a survey instrument consisting of four medication use situations that varied with the following: (1) new or previously used medication; (2) acute/chronic use; (3) self/dependent; (4) history/no history of adverse drug experiences; and (5) concomitant/no concomitant drug use. The respondents rated their likelihood of using three pharmacy services for each situation: (1) face-to-face communication with the pharmacist; (2) drug information leaflets; and (3) access to the pharmacist by telephone. Also, respondents were asked to indicate in which type of pharmacy they expect to find the three pharmacy services. RESULTS: Respondents identified five different groups of situations for face-to-face communication and access to pharmacist by telephone, and six different groups of situations for the drug information leaflet service. Concomitant drug use and history of adverse drug effects were common situational characteristics for which consumers indicated the highest likelihood of using pharmacy services. CONCLUSIONS: The context of prescription drug use must be accounted for in designing pharmacy services and in studying service quality from the patient perspective. The results provide evidence that consumers do desire different types of services, given the context in which they find themselves when they visit the pharmacy.

Measuring patient satisfaction with pharmaceutical services.

Common conceptualizations of satisfaction are discussed, and different ways of measuring patient satisfaction with pharmaceutical services are suggested. Patient satisfaction is becoming increasingly popular as an indicator of the quality of health care services, including pharmaceutical services. Satisfaction can be conceptualized as a performance evaluation, disconfirmation of expectations, an affect-based assessment, or an equity-based assessment. A satisfaction measure should have a theoretical base on which the measure's validity can be assessed. The measure chosen must fit the context of an overall research process, and the researcher must have a clear idea of what is to be measured. A large pool of items, or questions, for potential inclusion in a patient-satisfaction questionnaire can then be generated. The researcher should develop a format for each item (e.g., Likert scale). The items should be reviewed by experts for relevance and completeness. Questions that will help validate other questions should be included. To assess reliability and validity, the questionnaire should be given to a representative sample of respondents before being refined into its final format. Finally, the researcher must ensure that the patient-satisfaction questionnaire is practical (e.g., in terms of length and complexity). No single standard measure of patient satisfaction is applicable to all pharmacy situations. Researchers should either use an existing measure with demonstrated reliability and validity or develop a new measure by using a systematic process.

The "Drug export lag" and the Drug Export Amendments Act of 1986: an evaluation.

The purpose of this study was to evaluate the implementation of the Drug Export Amendments Act of 1986 (DEAA). The study methods involved calculating the time period between the submission of an application for export of a drug to the Food and Drug Administration (FDA) and its publication in the Federal Register, and the time taken by the FDA to reach a decision on the application. These parameters were then compared with the time limits specified in the DEAA. The analysis was conducted at four levels--overall for all pharmaceuticals, by therapeutic category of pharmaceutical, by country of export, and by type of company. At all four levels, we found that the publication and decision times were greater than the time limits specified in the DEAA. This suggests the existence of a "drug export lag," which includes a "publication time lag" (18.56 days) and an "FDA decision time lag" (182.26 days). The implications of these lags for the competitiveness of the US pharmaceutical industry in the global market are discussed and suggestions are provided.

Points to consider about prescription drug prices: an overview of federal policy and pricing studies.

Pharmaceutical prices in the United States are under evaluation as policy makers decide how to reduce health care expenditures and public subsidy of the pharmaceutical industry. Furthermore, evidence of higher drug prices in the United States, compared with those in other countries, fuels the prescription drug price debate. These issues are not new to the public forum and much can be learned from prior debates and policies. This paper begins by reviewing the pricing debate with the Kefauver hearings on monopolies held during the late 1950s and early 1960s and continues with the current price debate. Government reports and academic studies are discussed, addressing the methodological differences and their implications to policy makers. Finally, the literature review includes foreign government prescription drug programs with their respective prescription drug expenditures. Evidence provided by academics about the pricing practices of the drug manufacturers indicates product quality and price information would force firms to compete on the price level, thus reducing pharmaceutical product pricing to the "true" market price.

Regulation of biotechnology products in the global pharmaceutical market: the case of the European community and the United States.

Biotechnology represents an opportunity for innovative products, new markets, or capital investments, depending on one's perspective. A primary consideration in regulating this industry is to ensure that innovation is not stifled yet the public is protected from potentially unsafe or ineffective products. We compared the regulatory requirements and procedures for obtaining marketing approval for biotechnology products in the European Community (EC) and the United States and identified key concerns of the biotechnology industry regarding the regulatory aspects of these products. The methodology consisted of a secondary literature review and mail survey. Biotechnology products are approved faster in the EC than the US. Both the EC and the US use advisory or expert committees in their respective approval procedures, although the EC does so more regularly. Market exclusivity provisions for biotechnology products range from 6 to 10 years in the EC compared with 7 years for "orphan" biotechnology products in the US. Regulatory affairs managers of the biotechnology industry were most concerned about application review time periods, communication with regulatory agencies, consistency in implementing regulations, and public policy changes. These concerns provide insight into the deficiencies that exist in regulatory processes and are valuable in identifying problems and implementing improvements.

Evidence and response to the impact of the Medicaid Drug Rebate Program (OBRA) on hospital pharmacy: a progress report from central Ohio.

Preliminary results of a survey conducted by the American Society of Hospital Pharmacists (ASHP) indicated that hospital drug prices increased since the implementation of rebate agreements between Medicaid and drug manufacturers. The question of how hospital pharmacy directors are planning to respond to the cost-shifting that may occur in the recent future is raised in this article. Open-ended questions posed to Central Ohio Hospital directors assessed their expectations, experience, and proposed strategies in response to the rebate program. The respondents expect increases in drug prices, reductions in discounts for volume purchases, rebate programs, and contract purchases. Increases in the use of special dating on invoice, bundling of contract purchases, shorter time period for guaranteed prices, and shorter dating on invoices are also expected. Using stricter hospital formularies and capitalizing on the negotiating strength of purchasing groups, was the common strategy considered by hospital pharmacies.