Costs of Drug Therapy

The United States spends a larger share of its gross domestic product (GDP) on health than any other major industrialized country. In 1998, U.S. expenditures on health amounted to 13.0 of the GDP. To put this in perspective, the countries with the next highest shares of GDP spent on health were Switzerland and Germany (10.4 to 10.6 each) and Canada and France (9.5 to 9.6 ). The rate of increase in the medical care component of the consumer price index (CPI) increased to 4.1 in 2000 from 3.3 per...

Conclusion Looking Forward to Systematic Medications Use Management

The analysis leads us away from simple cause-and-effect explanations. It leads toward a systems model of drug therapy that includes organized patient monitoring and cooperative actions by patients, caregivers, physicians, nurses, pharmacists, and others. According to this model, the key to prevention is recognizing and correcting latent precursors of system failure called drug therapy problems. A well-constructed medicines management system would have a low likelihood of creating DTPs, a high...

Which Choice Is Optimal

An input, such as the four therapeutic alternatives in Table 5.3, is optimal when it minimizes or maximizes the relevant output, within specified boundary conditions. The incremental cost analysis does not tell us which alternative is optimal, because it presents a variety of output variables. Choosing an optimal alternative depends on five basic issues, collectively called the basis of the decision (1) the overall goal, (2) simplifying assumptions, (3) perspective and values, (4) decision...

Understanding Adverse Drug Therapy Outcomes

Chapter 2 summarized published data about the preventable drug-related morbidity (PDRM) problem the prevalence of preventable adverse outcomes of drug therapy. This problem causes significant human suffering and economic waste, perhaps throughout the industrialized world. Its severity may vary, however, among specific populations. Customary approaches to improving medications use have tended (a) to focus on an arbitrary part of the medicines use process such as prescribing or compliance, (b) to...

Summary of the Preventable DRM Model

The model developed in this chapter proposes a medications use process of patient assessment, prescribing, dispensing, consuming, and monitoring (Figure 3.1). 1. The medications use process can have three outcomes the therapeutic objective, a new medical problem created by therapy, or treatment failure. The three names for adverse outcomes are Adverse drug reactions (ADRs) any noxious and unintended effect caused by the drug itself. Adverse drug events (ADEs) patient injury caused by the drug...

I

(Therapy (Consume or Continues Administer) Diagram of the medications use process. and the patient or caregiver consumes or administers it (at home or in an institution).* Figure 3.2 shows the shadow of the medications use process depicted in Figure 3.1. During medications use, one or more errors may occur at each step. (Figure 3.2 ignores innocuous errors.) The physician may not recognize or not respond to an indication for drug therapy, may assess the patient incorrectly, form an incorrect...

Sickness and Legitimization

As illness denotes a person's feeling of not being well, and HQOL denotes a person's subjective feeling of capacity to perform normal activities and to meet normal obligations sickness is used to denote behavior consistent with illness or low HQOL. That is, a person may feel ill and act sick, for example, by not engaging in normal behavior such as recreation, work, or child care. Just as a person with a disease may or may not feel ill, a person who feels ill may or may not act sick. However,...

Summary and Conclusion

This chapter has described medications use indicators, ranging from familiar, but incomplete, prescribing indicators to a more complete approach using sets of outcome-process indicators. It seems clear that managed care and other health care programs do not take advantage of the potential value of the medications information that they possess. Considering (a) the magnitude of the problem, as described by research reports (Chapter 2), (b) the evidence that the causes are the inadequacies of...

Steps in Cost Effectiveness Analysis

Calculation of Table 5.3 is complicated and is best described as a series of steps 1. Outline the steps in therapy that are associated with costs relevant to the analysis. This may be descriptive of existing treatment guidelines or prescriptive of proposed treatment guidelines. Table 5.2 and Figure 5.1 are examples of the result of this step. 2. Identify the costs and probable outcomes for each therapeutic alternative. Cost information would usually be specific to a particular institution,...

Errors

The Harvard Medical Practice Study and the IOM report have emphasized the serious problem of human error in medicine.40 The MPS investigators looked for explanations of adverse events in terms of errors and negligence. Error was defined as a mistake in performance or thought. Negligence was a failure to meet the standard of care reasonably expected of an average physician qualified to take care of the patient in question. The Adverse Drug Event Prevention Study, a successor to the MPS, has...

Drug Therapy Process

A drug therapy process is a set of elements (people, objects, decisions, and procedures) that directly interact to provide drug therapy to individual patients (Figure 8.2). This is familiar to almost everyone. It begins when a patient enters care. The initiator (physician, nurse practitioner) takes a history, reviews physiologic systems, assesses medical problems, and prescribes a treatment.* The co-therapist (pharmacist, presumably) has minimal responsibilities to dispense the medications and...

Issues Influencing Adoption

Published research about the factors that influence adoption of a therapeutic innovation is somewhat limited, although one supposes that pharmaceutical manufacturers may have volumes of private information. Most of the published research in this area has been in consumer behavior and in agricultural practices. The following are factors that are commonly suggested to encourage or discourage adoption. Their application to prescribing seems plausible. Needs or problems that are easy to recognize...

Pharmaceutical Care and Pharmaceutical Care System

Brodie et al. introduced the concept of pharmaceutical care, in its modern sense, in 1980 1 Pharmaceutical care includes the determination of the drug needs for a given individual and the provision not only of the drug required but also the necessary services (before, during or after treatment) to assure optimally safe and effective therapy. It includes a feedback mechanism as a means of facilitating continuity of care by those who provide it. Hepler described pharmaceutical care in 1987 as a...

Objectives of Medication

Common objectives of drug therapy are summarized in Table 4.1. They are usually interrelated. Professionals typically use medicines to obtain a clinical Cure or control of disease Amelioration or control of symptoms Diagnosis Providing valuable product or service Expression of concern, legitimization Improved (or protected) health-related quality of life Comprehension (interpretation and understanding) of illness Legitimization and self-expression Compliance with authority (following...

Cost Shifting to Consumers

In addition to the objective of minimizing pharmacy benefit costs, which shifts costs among the components within a payer organization, some PrR programs may seek to shift costs to other payers, including the patient. Formularies can provide an indirect and covert means for denial of benefits, as in the West Virginia Medicaid example provided by Bloom and Jacobs.30 This strategy seems actually to have been recommended by Dranove Evidence suggests that neither an open nor a restrictive formulary...

Therapeutic Relationship

William May has proposed that the ideal relationship between professional and client is described as a covenant.8 As used here, a covenant is a solemn, secular, binding agreement between people (usually two) for the performance of unspecified actions or the exchange of unspecified gifts. There may be a contract contained in a covenant, but a contract is legally enforceable, while a covenant (as defined here) is not. Covenants transform relationships in ways that contracts cannot. Marriage is a...

Drug Product Withdrawals

Drug product withdrawals occur when a manufacturer or sponsor and the FDA decide that the benefits of an approved drug product no longer outweigh its safety risks. They follow, in effect, the reversal of a formal regulatory decision, based on expert opinion and rigorous scientific proof of safety and efficacy. Drug product withdrawals cause problems for patients and their doctors, the FDA, and pharmaceutical manufacturers. Some withdrawn products are useful for many patients and have no easy...

Worthless Drugs

One objective of the food and drug act is to prevent the marketing of worthless and unsafe drugs. Examples of drugs without proven therapeutic value are purported cancer cures like krebiozen and laetrile. However, drugs being promoted for nonscientific uses include more than these well-recognized examples. Prior to the 1962 Kefauver-Harris amendments to the FDCA, reputable pharmaceutical manufacturers promoted many drugs based on evidence of effectiveness that could not withstand scientific...

System Failures

We can define a system as a set of interdependent elements interacting to achieve a common aim. System elements may include people, equipment, and techniques.15 Reason's definition of error (above) refers to the actions of an individual. It also provides a ready template for a definition of system failure, which refers to the actions of many individuals (and, perhaps, of one individual over many discrete episodes) System failure is an occasion in which a planned sequence of discrete...

Calculating Efficiency

It is often possible to estimate, for each alternative therapy, the probabilities of the major steps in care. For example, see the flowchart in Figure 5.1. These data might be available as cure or remission rates from clinical studies. The clinical data that are extracted from clinical research literature are probably scientifically valid, but may only approximate true costs for a particular patient population. The costs of each step, e.g., the cost of a therapy, lab test, and clinic visit, can...

Unapproved and Off Label Uses

A second objective of the food and drug act is to prevent a manufacturer from promoting inappropriate uses of a drug after it has been approved for marketing (based on other uses). The issue of unapproved use is discussed further below. The criterion for FDA approval of an NDA or an ANDA is whether the benefits of a drug for its specific uses outweigh the risks for the same uses. Thus, thalidomide, originally proposed for use as a sedative and antinauseant, was deemed an unsafe drug and was...

Suboptimization and Values

Ashwell and New Hampshire Medicaid may not show a callous disregard for the needs of people in order to reduce costs. In the New Hampshire example, the overall program paid much more than the cost of the denied prescriptions. More likely, the cause of problems like Mr. Ash-well's death is a misguided effort to control one part of the health care mix at the expense of others. (Such decisions are called suboptimization.) By now the point may be clear enough, but it seems elusive...

Proposed Definition of Preventability

The following definition of preventability combines the major elements from the definitions summarized in Table 3.3, in the context of the DRM model given in Figure 3.1. A preventable DRM is defined as one with the following four attributes The DRM was preceded by a recognizable DTP. The DRM was reasonably foreseeable under the circumstances. The cause of the DTP and resulting DRM was identifiable. The identified cause of the DTP (and resulting DRM) was controllable within the context of...

The Second Drug Problem

How is it possible that modern medicine still does not provide care of known benefit sufficiently and correctly Quite simply, deficiencies in medical quality are due to inadequacies of organization, delivery, and financing systems. Drug therapy may be the most common modality of therapy in the industrialized world. In the United States, just under two thirds of all physician office visits include one or more prescriptions. The frequency of prescription use increases slightly with age (Figure...

Sentinel vs Rate Based

A sentinel event indicator measures an important process or outcome event that rarely or never occurs when quality is adequate. The indicator itself (or its quality implication) is usually so significant that each event requires more detailed analysis. Falls from bed by hospitalized patients is a classic example of a sentinel nursing care quality indication. Certain dispensing errors and the use of certain contraindicated drugs in combination would be examples of sentinel events in medications...

Sensitivity Analysis

The input values used in a decision analysis calculation are assumptions that may or may not be correct. For example, the drug cost (D) of a course of therapy may change for one or all of the alternatives. Likewise, clinic costs, sensitivity rates, etc., are estimates that may not turn out to be exactly as expected. Sensitivity refers to how much a calculated value would depend on these assumptions. In a one-way sensitivity analysis, one assumption is varied throughout a range that is...

Drug Therapy Problems

Another necessary building block for a model of medications use is the concept of a drug therapy problem. A drug therapy problem is any circumstance that a competent professional would judge to be inconsistent with achieving the objective of drug therapy. A DTP is overt, i.e., potentially detectable by a patient, caregiver, or professional, and is specific to a patient and time. In other words, DTPs are detectable in principle, although many may be undetected in fact. A DTP is part of the...

How to Get the SF36 and SF12

The SF-36, SF-12, and other HQOL measures, with manuals, instructional materials, etc., describing how to use them in research and clinical practice, are available from QualityMetric Inc., a company formed by John E. Ware, Jr., Ph.D., to develop and disseminate the next generation of outcome assessments and analytic services for improving health care from the patient point-of-view. QualityMetric Inc. and its affiliate, the Health Assessment Lab, have two locations Phone 401 334-8800 or 888...

Efficiency

Efficiency is the relationship of input to output, for example, a the cost per treated case, or b the degree to which the care has the desired effect with respect to the resources expended. Note that the cost of providing care is therefore not an outcome, but is associated with the inputs, i.e., the means of producing an outcome. While effectiveness addresses how well a technology performs in normal use , efficiency addresses the question of whether the technology is economically feasible or...

Preface

Katherine, 13, died suddenly on Thursday, July 3, 1997, at Hale Memorial Hospital. Beloved daughter of Carl and Joanne LaStima and sister of Steven. Private funeral services will be Monday, July 7, at Sacred Heart Church. Katherine LaStima was a normal schoolgirl with normal physical, mental, and social development, healthy except for chronic bronchial asthma. According to her parents, Katherine had asthma since she was a baby. She was in the care of Dr. Michael,...

PDRM Indicators

The four-part definition of preventability was validated by using it to construct specific definitions indicators of PDRM. In three separate studies, MacKinnon,44 Faris,45 and Morris et al.46 developed proposed indicators, each in the format of outcome process. Each was based on clinical literature connecting an adverse outcome with a pattern of care, e.g., excessive use of NSAIDs, lack of monitoring, and gastrointestinal bleeding. Each indicator was specific with regard to an adverse outcome...