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This is a difficult argument to refute ranitidine 150 mg without a prescription, especially to a public trained in the value of early detection and in the face of a clear breach in the standard of care cheap ranitidine 300 mg without a prescription. The Telephone A major pitfall for physicians is treating patients over the telephone order 300mg ranitidine overnight delivery. However buy generic ranitidine 300 mg line, the doctor must be satisfied that he or she has gathered all the necessary information and the patient understands the recommendation and the need for follow- up generic ranitidine 300 mg without prescription. In addition, it is critical that telephone conversations be documented and entered into the medical record. It is also necessary to inform the attending physician of any actions or encounters that occur in the on-call setting. Too often, malpractice suits hinge on a credibility test between the memory of the physician and the testimony of the patient. When there is any doubt, the doctor should meet the patient in the emergency room for a formal evaluation. A famous plaintiff attorney once stated that he would never have a problem earning a good living by suing doctors as long as they persisted in the “stupidity” of treating patients over the telephone. Chapter 8 / Risk Management 99 Prescription Errors These are a common source of litigation for family physicians. There are so many instances of patients receiving Purinethol when propylthiouracil was prescribed that in June 2003, GlaxoSmithKline sent health care professionals a “Medication Errors Alert,” warning of the consequences of this error. Patients must be well-informed regarding the drugs they are pre- scribed. It is a good idea to include the indication on the prescription so that a patient does not inadvertently take an antibiotic in place of an antihypertensive, for example. Because Purinethol has its name imprinted on every tablet, an informed patient would not take the wrong drug. Patients need to be alerted about other look-alike and sound-alike medications. They should also be alerted regarding correct dosages, allergies, side effects, and the appropriate use of controlled substances. Informed consent is required and should be documented, especially for drugs that may have serious side effects. Excessive prescribing and inappropriate use of prescription drugs are grounds for malpractice suits as well as loss of prescribing privileges and suspension or loss of a medical license. Refill practices must be clearly defined for the benefit of patients and pharmacists. The pharmacist must understand the physician’s policy concerning controlled substances. Steps must be taken to prevent hoarding and then overdosing at a later date. The patient must understand in advance the physician’s policy regarding lost pre- scriptions and drugs destroyed by the dog or flushed down the toilet or stolen from a woman’s purse. Some drugs that patients are permitted to refill require close monitoring. If a patient fails to comply with monitoring instructions, the privilege to refill may have to be withdrawn. Finally, there must be systems in place to warn patients of drug recalls. Procedures It is clearly a breach of the standard of care for physicians or their assistants to perform procedures for which they are not adequately trained. In one case, a woman’s face was badly scarred by a physician who was trained in the use of a laser by a salesperson. Soft tissue injections around the scapula or into an intercostal muscle have perforated lungs. Joint injections by those not properly trained have caused destructive septic arthritis. These and similar misadventures have led to lawsuits that are very difficult to defend. The Language Barrier The problems related to language barriers are well known to phy- sicians. Patients with limited English skills cannot be denied health care or in any way be discriminated against by health care providers. In 2000, President Clinton issued Executive Order 13166, requiring equal access to federally funded health care services for patients with limited English proficiency.

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Moreover order 300 mg ranitidine overnight delivery, these tests greatly influence other costs purchase 300mg ranitidine with amex, as they often preselect patients for more expensive procedures 150mg ranitidine. Yet the performance of such low-threshold diagnostics has often not been adequately evaluated discount ranitidine 300 mg with mastercard. Examples include many applications of haematological generic ranitidine 150 mg free shipping, clinicochemical, and urine tests. Complex relations Most diagnostics have more than one indication or are relevant for more than one nosological outcome. In addition, tests are often not applied in isolation but in combinations, for instance in the context of protocols. Ideally, diagnostic research should reflect the healthcare context,17 but it is generally impossible to investigate all aspects in one study. Therefore, 6 EVALUATION OF DIAGNOSTIC PROCEDURES choices must be made as to which issues are the most important. Multivariable statistical techniques are available to allow for the (added) value of various diagnostic data, both separately and in combination, and also in the form of diagnostic prediction rules. Diagnostic analysis aims to specify test performance in clinical subgroups or to identify the set of variables that yield the best individual diagnostic prediction, which is a completely different perspective. Much work remains to be done to improve the methodology of diagnostic data analysis. The “gold” standard problem To evaluate the discriminatory power of a test, its results must be compared with an independently established standard diagnosis. However, a “gold” standard, providing full certainty on the health status, rarely exists. Even x rays, CT scans and pathological preparations may produce false positive and false negative results. The aim must then be to define an adequate reference standard that approximates the “gold” standard as closely as possible. Sometimes one is faced with the question whether any appropriate reference standard procedure exists at all. For example, in determining the discrimination of liver tests for diagnosing liver pathology, neither imaging techniques nor biopsies can detect all abnormalities. In addition, as a liver biopsy is an invasive procedure it is unsuitable for use as a standard in an evaluation study. A useful independent standard diagnosis may not even exist conceptually, for example when determining the predictive value of symptoms that are themselves part of the disease definition, as in migraine, or when the symptoms and functionality are more important for management decisions than the anatomical status, as in prostatism. Also, in studying the diagnostic value of clinical examination to detect severe pathology in non-acute abdominal complaints, a comprehensive invasive standard diagnostic screening, if at all possible or ethically allowed, would yield many irrelevant findings and not all relevant pathology would be immediately found. An option, then, is diagnostic assessment after a follow up period by an independent panel of experts, representing a “delayed type” cross-sectional study. For example, as long as classic angiography is considered the standard when validating new vascular imaging techniques, the latter will always seem less valid because perfect agreement is never attainable. However, as soon as the new method comes to be regarded as sufficiently valid to be accepted as the 7 THE EVIDENCE BASE OF CLINICAL DIAGNOSIS standard, the difference will from then on be explained in favour of this new method. In addition, when comparing advanced ultrasound measurements in blood vessels with angiography, one must accept that the two methods actually measure different concepts: the first measures blood flow, relevant to explain the symptoms clinically, whereas the second reflects the anatomical situation, which is important for the surgeon. Furthermore, the progress of clinicopathological insights is of great importance. For example, although clinical pattern X may first be the standard to evaluate the significance of microbiological findings, it will become of secondary diagnostic importance once the infectious agent causing X has been identified. The agent will then be the diagnostic standard, as illustrated by the history of the diagnosis of tuberculosis. In Chapters 3 and 6 more will be said about reference standard problems. Spectrum and selection bias The evaluation of diagnostics may be flawed by many types of bias. Spectrum bias may occur when the discrimination of the diagnostic is assessed in a study population with a different clinical spectrum (for instance in more advanced cases) than will be found among those in whom the test is to be applied in practice. This may, for example, happen with tests calibrated in a hospital setting but applied in general practice. Also, sensitivity may be determined in seriously diseased subjects, whereas specificity is tested in clearly healthy subjects. Both will then be grossly overestimated relative to the practical situation, where testing is really necessary because it is clinically impossible to distinguish in advance who is healthy and who is diseased.

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In the 1980s buy 300mg ranitidine with visa, hospitals and physicians could generally pass a significant Chapter 16 / Health Policy Review 235 portion of such costs to payers (63) cheap ranitidine 150mg without a prescription. The spread of managed care buy discount ranitidine 300 mg, the advent of strong price controls in Medicare (with very little adjust- ment generic ranitidine 150mg visa, especially recently) buy ranitidine 300mg without prescription, and the widespread adoption of fee sched- ules by private insurers have lowered net incomes (64), rendering physicians less able to cope with hikes in practice costs than in earlier tort crises. Second, the present crisis occurs in the shadow of the new patient safety movement (65). The Institute of Medicine’s 2000 Report on medical error (66) galvanized public attention; almost overnight, it catapulted medical injury from a relatively obscure topic in health ser- vices research to the forefront of the nation’s health policy agenda. Although the report skirted the topic of liability, the interconnectedness of patient safety and malpractice is increasingly apparent. THE “TWO CULTURES” PROBLEM: MALPRACTICE LAW AND PATIENT SAFETY The malpractice system lies in deep tension with the goals and initia- tives of the patient safety movement. At root, there is a problem of two cultures (67): trial attorneys believe that the threat of litigation makes doctors practice more safely, but tort law’s punitive, individualistic, adversarial approach is antithetical to the nonpunitive, systems-oriented, cooperative strategies promoted by patient safety leaders. To learn from errors, we must first identify them; to identify them, we must foster an atmosphere conducive to openness about mistakes (68). Hospitals and physicians are urged to be honest with patients about injury and medical error, to report such events to one another and to regulators, and to address methods of prevention openly (69). To nurture openness, experts stress that most errors arise from proficient clinicians working in faulty systems, not from incompetence or carelessness (66). In sharp contrast, tort law targets individuals, assigning blame and compensation based on proof of negligence. Before, during, and after litigation, information about injuries and their surrounding circum- stances is kept hidden. Risk-management activities typically are divorced from quality improvement (70). The clash between tort and patient safety cultures acts as a drag on efforts to improve quality. Concerns about malpractice exposure dimin- ish the health care industry’s appetite for patient safety activities (71– 73). The reluctance of physicians to buy into such activities stems from the perception that they are being asked to be open about errors with 236 Studdert, Mello, and Brennan little or no assurance of legal protection at a time when litigation is on the rise, malpractice insurance is increasingly expensive and difficult to find, and claims history bears significantly on insurance prospects. This reluctance has manifested in several ways, but two of the most important are underreporting to adverse event reporting systems and chilled com- munication with patients about errors, especially preventable ones (74,75). Thus, in spite of malpractice law’s mission to improve quality through deterrence—indeed, perhaps because of it—litigation fears obstruct progress in patient safety. The harsh reality is that greater publicity about mistakes, disclosure to patients, and access to reported information probably would increase litigation. Such corroborative information promises reduced time and costs for initiating litigation, shifting the plaintiff attorney’s calculus in the direction of more law- suits. Proponents of malpractice litigation applaud this, citing the prevalence of uncompensated negligent injuries and reiterating the importance of litigation as a deterrent. Critics are apprehensive and attempt to ensure that reporting systems are closed to the public. They may also seek to persuade providers that honest disclosure of errors actually decreases the probability of expensive litigation. Despite anecdotal reports of such positive experiences (75,76), the notion that disclosure reduces litigation is largely unproven and somewhat implausible. TORT REFORM Each tort crisis has stimulated enthusiasm tort reform among policy- makers. For example, screening panels force an evaluation of the merits of claims before they reach court. Their goal is to encourage settlement and stop nonmeritorious claims before they turn into protracted litigation. Another type of access constraint involves shortening statutes of limi- tation (time periods within which plaintiffs are permitted to sue after discovering their injury) or enacting statutes of repose (time limits that run from the date of the allegedly negligent event rather than discovery of the injury). The second family of reforms modifies liability rules in an effort to reduce both the frequency of claims and the size of payouts. For example, eliminating joint-and-several liability means that a plaintiff may recover from multiple defendants only in proportion to their con- Chapter 16 / Health Policy Review 237 Table 1 Malpractice Reform Options Conventional tort reform Limitations on Modification access to courts of liability rules Damages reform • Statute of limitations/ • Joint and several lia- • Caps repose bility rules • Attorney fee limits • Screening panels • Informed consent • Collateral source rules • Res ipsa loquitur • Periodic payment System reform Alternative mechanisms Alternatives Relocation of legal for resolving disputes to negligence responsibility • Early offers • “No-fault” administra- • Enterprise liability • Medical courts tive system • Private contracts • Predesignated com- • Fault-based admini- pensable events strative system tribution to causing the injury. Many states have enacted legislation reversing judicial expansions of liability (77). Elimination of the doc- trine of res ipsa loquitur, new standards for expert witnesses, and the imposition of higher standards for establishing breaches of informed consent all are examples of such retrenchment. The third family of reforms directly addresses the size of awards, with caps on damages awards being by far the most prominent measure.

Explain how the matrix permits specific kinds of cells to be even more effec- tive and functional as tissues cheap ranitidine 150mg visa. Histology © The McGraw−Hill Anatomy buy 300 mg ranitidine with visa, Sixth Edition of the Body Companies ranitidine 150mg free shipping, 2001 Developmental Exposition Embryoblast Blastocoele Amniotic cavity (c) Trophoblast Ectoderm Endoderm (b) Amniotic cavity (d) Ectoderm Embryonic disc Mesoderm (a) Endoderm Yolk sac Trophoblast (e) Schenk EXHIBIT 1 The early stages of embryonic development buy 300mg ranitidine with amex. Within 30 hours after fertilization purchase ranitidine 150 mg fast delivery, the zygote undergoes a The Tissues mitotic division as it moves through the uterine tube toward the uterus (see chapter 22). After several more cellular divisions, the embryonic mass consists of 16 or more cells and is called a EXPLANATION morula (mor′yoo-la˘), as shown in exhibit I. Three or 4 days after Human prenatal development is initiated by the fertilization of conception, the morula enters the uterine cavity where it re- an ovulated ovum (egg) from a female by a sperm cell from a mains unattached for about 3 days. The chromosomes within the nucleus of a zygote (zı˘go¯t) of the morula fills with fluid absorbed from the uterine cavity. As (fertilized egg) contain all the genetic information necessary for the fluid-filled space develops inside the morula, two distinct the differentiation and development of all body structures. There are two major categories of epithelia: membranous and Objective 6 Define gland and compare and contrast the glandular. Membranous epithelia are located throughout the body various types of glands in the body. Glandular epithelia are specialized tissues that form the secretory portion of glands. Characteristics of Membranous Epithelia Objective 4 Compare and contrast the various types of Membranous epithelia always have one free surface exposed to a membranous epithelia. Histology © The McGraw−Hill Anatomy, Sixth Edition of the Body Companies, 2001 (continued) TABLE 4A Derivatives of the Germ Layers Ectoderm Mesoderm Endoderm Epidermis of skin and epidermal derivatives: Muscle: smooth, cardiac, skeletal Epithelium of pharynx, auditory canal, tonsils, hair, nails, glands of the skin; linings of oral, Connective tissue: embryonic, mesenchyme, thyroid, parathyroid, thymus, larynx, trachea, nasal, anal, and vaginal cavities connective tissue proper, cartilage, bone, blood lungs, GI tract, urinary bladder and urethra, and Nervous tissue; sense organs vagina Dermis of skin; dentin of teeth Lens of eye; enamel of teeth Liver and pancreas Epithelium (endothelium) of blood vessels, Pituitary gland lymphatic vessels, body cavities, joint cavities Adrenal medulla Internal reproductive organs Kidneys and ureters Adrenal cortex wall is known as the trophoblast, and the inner aggregation of is closer to the amniotic cavity, and a lower endoderm, which cells is known as the embryoblast. A short time later, a the trophoblast differentiates into a structure that will later form third layer called the mesoderm forms between the endoderm and part of the placenta; the embryoblast will eventually become the ectoderm. With the establishment of these two groups of cells, the The primary germ layers are of great significance because morula becomes known as a blastocyst (blas′to˘-sist). Implantation all the cells and tissues of the body are derived from them (see of the blastocyst in the uterine wall begins between the fifth and fig. Ectodermal cells form the nervous system; the outer seventh day (see chapter 22). Mesodermal cells form the week of development, the embryoblast undergoes marked differen- skeleton, muscles, blood, reproductive organs, dermis of the skin, tiation. A slitlike space called the amniotic (am′ne-ot-ic) cavity and connective tissue. Endodermal cells produce the lining of the forms within the embryoblast, adjacent to the trophoblast. The GI tract, the digestive organs, the respiratory tract and lungs, and embryoblast now consists of two layers: an upper ectoderm, which the urinary bladder and urethra. The upper surface may be exposed to gases, as in the case Some of the functions of membranous epithelia are quite of epithelium in the integumentary and respiratory systems; to specific, but certain generalities can be made. Epithelia that cover liquids, as in the circulatory and urinary systems; or to semisolids, or line surfaces provide protection from pathogens, physical injury, as in the GI tract. Epithelia lining the GI tract function in lia is bound to underlying supportive tissue by a basement mem- absorption. The epithelium of the kidneys provides filtration, brane, that consists of glycoprotein from the epithelial cells and whereas that within the pulmonary alveoli (air sacs) of the lungs a meshwork of collagenous and reticular fibers from the underly- allows for diffusion. With few exceptions, membranous epithe- buds and in the nasal region has a chemoreceptor function. Histology © The McGraw−Hill Anatomy, Sixth Edition of the Body Companies, 2001 Chapter 4 Histology 81 (b) (c) (a) FIGURE 4. Simple squamous epithelia that line the lumina of vessels are referred to as endothelia, and that which cover visceral or- gans are referred to as mesothelia. Many membranous epithelia are exposed to friction or spherical central nucleus. This epithelium is adapted for diffusion harmful substances from the outside environment. It occurs in the pulmonary alveoli within the son, epithelial tissues have remarkable regenerative abilities. The lungs (where gaseous exchange occurs), in portions of the kidney mitotic replacement of the outer layer of skin and the lining of (where blood is filtered), on the inside walls of blood vessels, in the GI tract, for example, is a continuous process.

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