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Justification-Based Pharmacy Benefits
Abstract
Managed care pharmacists are involved formally with the interface between the delivery and financing of health care; their work thus entails an accountability for both elements. Interpreted broadly, managed care pharmacists are pharmacists working within the sphere of a health care system, health care purchaser, health insurer, managed care organization, or benefit administration agency. Patients, the pharmacy profession, and society are best served by this broad interpretation, because the interdependency of financing and delivery is inextricably linked to the achievement of good health outcomes. This continuing feature will explore contemporary issues facing managed care pharmacists.
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Pharmacists are assuming increasingly important positions in the insurance, managed care, and phar-macy benefits industries. In these positions, pharmacists are making decisions about prescription drug coverage and benefit management practices that have material effects on plan members. Substantial pressure to reduce the rising costs of pharmacy benefits during the past few years has introduced ethi-cal challenges to pharmacists in these environments. Many pharmacists have risen to the challenges and negotiated good outcomes for plan members. Too many of them, however, have not. In this paper, I describe some of the activities that I have observed that may not pass ethical judgment. I propose a typology of pharmacists as a means to understand the reasons they may not make the right choices from time to time, and I provide arguments that can be used to recruit pharmacists to the right way of thinking. My intention is to engage the pharmacy academic community in addressing ethical challenges pharmacists face in certain aspects of pharmacy benefits. Pharmacists have successfully negotiated difficult ethi-cal problems on many occasions, but not always. In too many cases, at least to this observer, pharmacists have not risen to the ethical challenges presented to them.
EDITOR—Isaacs and Fitzgerald's short paper on alternatives to evidence based medicine seems to establish a new classification in the art of medicine.1 I would like to make a small but practical nosological contribution. Eminence based, eloquence based, and confidence based medicine could be grouped into the single entity narrative based medicine (a term borrowed from Carlo Favaretti). Notwithstanding the fact that each of these individual disciplines has a longstanding tradition, their strong chat based rather than fact based component makes them similar enough to justify the suggested aggregation. Although the authors skilfully depict the consensus and decision making processes that are adopted in practice, I believe, however, that they have ignored a commonly used eighth alternative—namely, propaganda based medicine. If doctors have only a limited amount of time for scientific training, if they swallow anything they are told, or if they find themselves in any other unmentionable circumstance they may fall prey to pharmaceutical representatives with the best strategies for physician-changing behaviour. In clinical practice the markers for the two types of propaganda based medicine are (a) gullibility and (b) unexplainable variation in the prescription of drugs. For the first type, for example, the measuring devices are reactions to test questions such as “How would you react if you had a 40 000-legged spider on your back?” and the unit of measurement is the rate of frightened responses. I fear that the only reason why propaganda based medicine has not been included, particularly the gullible variety, is that the term does not rhyme with “ence.” References1.↵Isaacs D, Fitzgerald D.Seven alternatives to evidence based medicine.BMJ1999;319: 1618. (18-25 December.)
Doctors within the NHS are confronting major changes at work. While we endeavour to improve the quality of health care, junior doctors' hours have been reduced and the emphasis on continuing medical education has increased. We are confronted by a growing body of information, much of it invalid or irrelevant to clinical practice. This article discusses evidence based medicine, a process of turning clinical problems into questions and then systematically locating, appraising, and using contemporaneous research findings as the basis for clinical decisions. The computerisation of bibliographies and the development of software that permits the rapid location of relevant evidence have made it easier for busy clinicians to make best use of the published literature. Critical appraisal can be used to determine the validity and applicability of the evidence, which is then used to inform clinical decisions. Evidence based medicine can be taught to, and practised by, clinicians at all levels of seniority and can be used to close the gulf between good clinical research and clinical practice. In addition it can help to promote self directed learning and teamwork and produce faster and better doctors
Drug therapy for hypercholesterolaemia has remained controversial mainly because of insufficient clinical trial evidence for improved survival. The present trial was designed to evaluate the effect of cholesterol lowering with simvastatin on mortality and morbidity in patients with coronary heart disease (CHD). 4444 patients with angina pectoris or previous myocardial infarction and serum cholesterol 5·5-8·0 mmol/L on a lipid-lowering diet were randomised to double-blind treatment with simvastatin or placebo.Over the 5·4 years median follow-up period, simvastatin produced mean changes in total cholesterol, low-density-lipoprotein cholesterol, and high-density-lipoprotein cholesterol of -25%, -35%, and +8%, respectively, with few adverse effects. 256 patients (12%) in the placebo group died, compared with 182 (8%) in the simvastatin group. The relative risk of death in the simvastatin group was 0·70 (95% Cl 0·58-0·85, p=0·0003). The 6-year· probabilities of survival in the placebo and simvastatin groups were 87·6% and 91·3%, respectively. There were 189 coronary deaths in the placebo group and 111 in the simvastatin group (relative risk 0·58, 95% Cl 0·46-0·73), while noncardiovascular causes accounted for 49 and 46 deaths, respectively. 622 patients (28%) in the placebo group and 431 (19%) in the simvastatin group had one or more major coronary events. The relative risk was 0·66 (95% Cl 0·59-0·75, p<0·00001), and the respective probabilities of escaping such events were 70·5% and 79·6%. This risk was also significantly reduced in subgroups consisting of women and patients of both sexes aged 60 or more. Other benefits of treatment included a 37% reduction (p<0·00001) in the risk of undergoing myocardial revascularisation procedures.This study shows that long-term treatment with simvastatin is safe and improves survival in CHD patients.
A NEW paradigm for medical practice is emerging. Evidence-based medicine de-emphasizes intuition, unsystematic clinical experience, and pathophysiologic rationale as sufficient grounds for clinical decision making and stresses the examination of evidence from clinical research. Evidence-based medicine requires new skills of the physician, including efficient literature searching and the application of formal rules of evidence evaluating the clinical literature.An important goal of our medical residency program is to educate physicians in the practice of evidence-based medicine. Strategies include a weekly, formal academic half-day for residents, devoted to learning the necessary skills; recruitment into teaching roles of physicians who practice evidence-based medicine; sharing among faculty of approaches to teaching evidence-based medicine; and providing faculty with feedback on their performance as role models and teachers of evidence-based medicine. The influence of evidencebased medicine on clinical practice and medical education is increasing.CLINICAL SCENARIO
A junior medical resident working in a teaching hospital
The central idea for this book is that we lack consensus on principles for allocating resources and in the absence of such a consensus we must rely on a fair decision-making process for setting limits on health care. The authors characterize key elements of this process in a variety of health care contexts where such decisions are made- decisions about insurance coverage for new technologies, pharmacy benefit management, the design of physician incentives, contracting for mental health care by public agencies, etc.- and they connect the problem in the U.S. with the same problem in other countries. They provide a cogent analysis of the current situation, lucidly review the usual candidate solutions, and describe their own approach, which represents a clear advance in thinking. Their intended audience is international since the problem of limits cuts across types of health care systems whether or not they have universal coverage. Available in OSO: http://www.oxschol.com/oso/public/content/publichealthepidemiology/9780195149364/toc.html
The natural history of and the effect of propranolol on ventricular arrhythmias post-myocardial infarction were analyzed using data from the Beta-Blocker Heart Attack Trial (BHAT). The Beta-Blocker Heart Attack Trial was a multicenter, randomized, double-blind, placebo-controlled trial among 3,837 patients entered from 5 to 21 days after hospitalization for acute myocardial infarction. At baseline, prior to randomization, 3,290 (85.7%) patients underwent 24-hr ambulatory ECG monitoring which was repeated in approximately 25% of a randomly selected subset of the study population at 6 weeks. Ventricular arrhythmias were divided into eight different categories which defined the prevalence of ventricular arrhythmias in terms of frequency and/or complexity. Ventricular arrhythmias at baseline were associated with age, past history of myocardial infarction, and use of diuretics and digitalis. Paired data (baseline and 6-week) were available for 428 patients on propranolol and 412 on placebo. Propranolol markedly blunted the two- to threefold increase in ventricular arrhythmias that occurred from baseline to 6 weeks in the placebo group. Propranolol decreased the proportion of patients having ventricular arrhythmias during waking hours compared with sleep. These data show that propranolol has an antiarrhythmic effect and suggest that an antiarrhythmic mechanism may in part be responsible for the observed reduction in sudden cardiac death mortality in BHAT.
Platelet glycoprotein (GP) IIb/IIIa antagonists prevent the composite end point of death or myocardial infarction (MI) in patients with acute coronary syndromes. There is uncertainty about whether this effect is confined to patients who have percutaneous coronary interventions (PCIs) and whether PCIs further prevent death or MI in patients already treated with GP IIb/IIIa antagonists.
PURSUIT patients were treated with the GP IIb/IIIa antagonist eptifibatide or placebo; PCIs were performed according to physician practices. In 2253 of 9641 patients (23.4%), PCI was performed by 30 days. Early (<72 hours) PCI was performed in 1228 (12.7%). In 34 placebo patients (5.5%) and 10 treated with eptifibatide (1.7%) (P=0.001), MI preceded early PCI. In patients censored for PCI across the 30-day period, there was a significant reduction in the primary composite end point in eptifibatide patients (P=0.035). Eptifibatide reduced 30-day events in patients who had early PCI (11.6% versus 16.7%, P=0.01) and in patients who did not (14.6% versus 15.6%, P=0.23). After adjustment for PCI propensity, there was no evidence that eptifibatide treatment effect differed between patients with or without early PCI (P for interaction=0.634). PCI was not associated with a reduction of the primary composite end point but was associated with a reduced (nonspecified) composite of death or Q-wave MI. This association disappeared after adjustment for propensity for early PCI.
Eptifibatide reduced the composite rates of death or MI in PCI patients and those managed conservatively.
The debate about justice and health care has occurred largely at a remove from the institutions it concerns; it has been about our most general moral principles, and about what things we value. This debate has foundered. But if the debate is turned in another direction, toward some moral principles that are widely accepted within those institutions, and toward principles that have to do with control over allocation decisions rather than with actually how to make those decisions, agreement may be nearer at hand.
1 NORMAN DANIELS is Goldthwaite Professor in the Department of Philosophy at Tufts University. His most recent books include Justice and Justification: Reflective Equilibrium in Theory and Practice (Cambridge, 1996), and, with Donald Light and Ronald Caplan, Benchmarks of Fairness for Health CareReform (Oxford, 1996). His current work in ethics and health policy includes a project to adapt the Benchmarks to monitor reform in developing countries. This is his first appearance in Philosophy & Public Affairs.
Recently approved drugs may be more likely to have unrecognized adverse drug reactions (ADRs) than established drugs, but no recent studies have examined how frequently postmarketing surveillance identifies important ADRs.
To determine the frequency and timing of discovery of new ADRs described in black box warnings or necessitating withdrawal of the drug from the market.
Examination of the Physicians' Desk Reference for all new chemical entities approved by the US Food and Drug Administration between 1975 and 1999, and all drugs withdrawn from the market between 1975 and 2000 (with or without a prior black box warning).
Frequency of and time to a new black box warning or drug withdrawal.
A total of 548 new chemical entities were approved in 1975-1999; 56 (10.2%) acquired a new black box warning or were withdrawn. Forty-five drugs (8.2%) acquired 1 or more black box warnings and 16 (2.9%) were withdrawn from the market. In Kaplan-Meier analyses, the estimated probability of acquiring a new black box warning or being withdrawn from the market over 25 years was 20%. Eighty-one major changes to drug labeling in the Physicians' Desk Reference occurred including the addition of 1 or more black box warnings per drug, or drug withdrawal. In Kaplan-Meier analyses, half of these changes occurred within 7 years of drug introduction; half of the withdrawals occurred within 2 years.
Serious ADRs commonly emerge after Food and Drug Administration approval. The safety of new agents cannot be known with certainty until a drug has been on the market for many years.
- Isaacs D.