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By: P. Leon, M.B.A., M.B.B.S., M.H.S.
Professor, Pacific Northwest University of Health Sciences
Some items menstruation fatigue cheap 20mg fluoxetine with mastercard, such as transparent film menopause odor change generic fluoxetine 20mg with mastercard, may be used as a primary or secondary dressing breast cancer walk in chicago buy generic fluoxetine 20mg on-line. If a physician women's health center tulsa ok discount 20 mg fluoxetine with amex, certified nurse midwife, physician assistant, nurse practitioner, or clinical nurse specialist applies surgical dressings as part of a professional service that is billed to Medicare, the surgical dressings are considered incident to the professional services of the health care practitioner. Splints and casts, and other devices used for reductions of fractures and dislocations are covered under Part B of Medicare. See the Medicare Claims Processing Manual, Chapter 20, "Durable Medical Equipment, Surgical Dressings and Casts, Orthotics and Artificial Limbs, and Prosthetic Devices," for a detailed description of payment rules for each classification. Payment may also be made for repairs, maintenance, and delivery of equipment and for expendable and nonreusable items essential to the effective use of the equipment subject to the conditions in §110. See the Medicare Benefit Policy Manual, Chapter 11, "End Stage Renal Disease," for hemodialysis equipment and supplies. All requirements of the definition must be met before an item can be considered to be durable medical equipment. Medical supplies of an expendable nature, such as incontinent pads, lambs wool pads, catheters, ace bandages, elastic stockings, surgical facemasks, irrigating kits, sheets, and bags are not considered "durable" within the meaning of the definition. There are other items that, although durable in nature, may fall into other coverage categories such as supplies, braces, prosthetic devices, artificial arms, legs, and eyes. Medical Equipment Medical equipment is equipment primarily and customarily used for medical purposes and is not generally useful in the absence of illness or injury. In most instances, no development will be needed to determine whether a specific item of equipment is medical in nature. However, some cases will require development to determine whether the item constitutes medical equipment. This development would include the advice of local medical organizations (hospitals, medical schools, medical societies) and specialists in the field of physical medicine and rehabilitation. If the equipment is new on the market, it may be necessary, prior to seeking professional advice, to obtain information from the supplier or manufacturer explaining the design, purpose, effectiveness and method of using the equipment in the home as well as the results of any tests or clinical studies that have been conducted. Equipment Presumptively Medical Items such as hospital beds, wheelchairs, hemodialysis equipment, iron lungs, respirators, intermittent positive pressure breathing machines, medical regulators, oxygen tents, crutches, canes, trapeze bars, walkers, inhalators, nebulizers, commodes, suction machines, and traction equipment presumptively constitute medical equipment. See the Medicare Benefit Policy Manual, Chapter 11, "End Stage Renal Disease," §30. Equipment Presumptively Nonmedical Equipment which is primarily and customarily used for a nonmedical purpose may not be considered "medical" equipment for which payment can be made under the medical insurance program. For example, in the case of a cardiac patient, an air conditioner might possibly be used to lower room temperature to reduce fluid loss in the patient and to restore an environment conducive to maintenance of the proper fluid balance. Nevertheless, because the primary and customary use of an air conditioner is a nonmedical one, the air conditioner cannot be deemed to be medical equipment for which payment can be made. These include, for example, room heaters, humidifiers, dehumidifiers, and electric air cleaners. Equipment which basically serves comfort or convenience functions or is primarily for the convenience of a person caring for the patient, such as elevators, stairway elevators, and posture chairs, do not constitute medical equipment. Similarly, physical fitness equipment (such as an exercycle), first-aid or precautionary-type equipment (such as preset portable oxygen units), self-help devices (such as safety grab bars), and training equipment (such as Braille training texts) are considered nonmedical in nature. These items would be covered when it is clearly established that they serve a therapeutic purpose in an individual case and would include: a. Gel pads and pressure and water mattresses (which generally serve a preventive purpose) when prescribed for a patient who had bed sores or there is medical evidence indicating that they are highly susceptible to such ulceration; and b. Coverage in a particular case is subject to the requirement that the equipment be necessary and reasonable for treatment of an illness or injury, or to improve the functioning of a malformed body member. These considerations will bar payment for equipment which cannot reasonably be expected to perform a therapeutic function in an individual case or will permit only partial therapeutic function in an individual case or will permit only partial payment when the type of equipment furnished substantially exceeds that required for the treatment of the illness or injury involved. The following considerations should enter into the determination of reasonableness: 1. Would the expense of the item to the program be clearly disproportionate to the therapeutic benefits which could ordinarily be derived from use of the equipment? Is the item substantially more costly than a medically appropriate and realistically feasible alternative pattern of care?
The lack of characterization data for the range of Aloe products used in these trials makes it difficult to draw any meaningful conclusion regarding the relationship of safety and efficacy of Aloe vera with the quality attributes of Aloe vera products pregnancy countdown purchase fluoxetine 10 mg with visa. Aloe vera women's health center at presbyterian dallas purchase fluoxetine 20 mg online, the botanical raw material women's gynecological health issues cheap fluoxetine 20mg, is widely used topically in herbal preparations for treatment of various skin conditions contemporary women's health issues for today and the future 4th edition pdf generic fluoxetine 10 mg free shipping, most notably for wound healing (Tyler 1994). Aloe vera is said to assist in wound healing and is often used in cosmetics for its moisturizing and emollient properties (Dewick 1997). It is also a common ingredient in cosmetics 19 products like lotions, ointments, creams, and shampoos. The carboxypeptidase and salicylate of Aloe gel can inhibit bradykinin, a pain producing agent while magnesium lactate can inhibit histamine with the potential to reduce itching (Klein 1988). Although preliminary studies of fresh Aloe vera gel suggested that it may be an effective treatment of minor skin ailments, the effectiveness of Aloe preparations is still not confirmed because the Aloe preparations studied were not standardized, and well-controlled large clinical studies are still lacking (Tyler 1994; Muller et al. Aloe latex has traditionally been used orally as a laxative to relieve constipation. The potent laxative effects are due to the cleaved tricyclic anthracene nucleus in the anthraquinones that form anthrones in the colon, which irritate mucous membranes, leading to increased mucous secretion and peristalsis (Gennaro, 1996). Fluid and electrolyte secretion into the lumen are increased and the cathartic effects occur within 10 hours of ingestion while water and electrolyte reabsorption are inhibited and the loss of potassium from cells paralyzes the intestinal muscles (Wichtl et al. Some preliminary data suggest anthraquinone may have mutagenic and carcinogenic effects, but the data are conflicting. How widespread its use has been Aloe vera is not approved as a drug in the United States in any form, and the extent of applications in compounding pharmacy may be limited. In addition, Aloe vera is one of the commonly used herbal medicines in many parts of the world, including the most populous countries like China and India. Conclusions Aloe vera leaf and latex are among the commonly used herbal medicines in many parts of the world with popular dietary supplement and food use in the recent decades. In addition, numerous topical products containing Aloe vera gel have been used or tested in clinical trials for the treatment of wounds and burns. However, those Aloe vera products previously used or studied were poorly characterized with no sufficient quality information to draw meaningful connections with the nominated substance Aloe vera (gel) freeze-dried (200:1). In addition, no 20 specific human experience to directly support the potential use of the nominated substance, Aloe vera (gel) freeze-dried (200:1), as a topical treatment for burns and wounds is provided by the nominator or available in literature. Although Aloe vera generally (not specific to the 200:1 freeze dried extract that was nominated) has been used for millennia, we recommend that it not be included on the list of bulk drug substances allowed for use in compounding based on the following: 1. Aloe vera extract is used as a general term, and no adequate product quality information was provided in literature (or by the nominator) to allow differentiation of Aloe vera freeze dried 200:1, the nominated substance, from other Aloe extracts. Aloe vera may contain various classes of molecules, and it is not well characterized in its physical and chemical properties (especially the major components, polysaccharides). Additionally, raw material collection, storage, and the manufacturing processes used may change the physiochemical properties of the Aloe extract (especially the polysaccharides), making characterization and adequate quality control to ensure safety and efficacy for drug use even more difficult to achieve. Although the oral use of Aloe vera gel (mostly polysaccharides without anthraquinones) as dietary supplement/food appears to be reasonably safe, topical use of Aloe extract (especially those containing anthraquinones) on open wounds should be avoided because of the inability to differentiate potential contaminants from other botanicals by routine chemical analysis. There is insufficient and conflicting information from controlled clinical trials regarding efficacy of the Aloe vera topical products in the topical treatment of cuts, burns, and wounds. Furthermore, it is not clear whether the products used in those trials contained 200:1 freeze dried Aloe vera. Although short-term application of small amounts of topical Aloe vera products may have an acceptable dermal safety profile, there is a lack of long-term dermal safety data and pharmacokinetic data, which are necessary for full safety evaluation of topical products. The safety profile of Aloe vera shows that the anthraquinone derivative in Aloe latex may be unsafe, especially when used at high doses for repeated use. Nonclincal data also raise concern, showing that Aloe vera has abortifacient activity when taken orally and it induced skeletal malformations in an oral embryofetal toxicity study in rats. There is no information on the safety of 200:1 freeze dried Aloe products for topical use. For the reasons stated above, we do not recommend that 200:1 freeze dried Aloe vera be included on the list of bulks drug substances for use in compounding. An evaluation of the biological and toxicological properties of Aloe barbadensis (miller), Aloe vera. Clear evidence of carcinogenic activity by a whole-leaf extract of Aloe barbadensis miller (Aloe vera) in F344/N rats. Final report on the safety assessment of AloeAndongensis Extract, Aloe Andongensis Leaf Juice,Aloe Arborescens Leaf Extract, Aloe Arborescens Leaf Juice, Aloe Arborescens Leaf Protoplasts, Aloe Barbadensis Flower Extract, Aloe Barbadensis Leaf, Aloe Barbadensis Leaf Extract, Aloe Barbadensis Leaf Juice,Aloe Barbadensis Leaf Polysaccharides, Aloe Barbadensis Leaf Water, Aloe Ferox Leaf Extract, Aloe Ferox Leaf Juice, and Aloe Ferox Leaf Juice Extract.
Given the close interrelationships among diet menopause osteoporosis purchase 10mg fluoxetine otc, exercise pregnancy yellow discharge fluoxetine 10mg mastercard, and physiological risks on the one hand breast cancer 60 mile walk discount 10 mg fluoxetine fast delivery, or among water pregnancy day by day calendar purchase fluoxetine 20mg with amex, sanitation, and personal hygiene on the other, the exact definition of what a risk factor is requires careful attention. Similarly, the assessment of unsafe sex separately from that of non-use and use of ineffective methods of contraception does not override their close linkages. Rather, we focused the analysis on risk factors for which we were likely to be able to satisfactorily quantify their population exposure distributions and health effects using existing scientific evidence and available data and for which intervention strategies are available or might be envisioned. Estimating Population Attributable Fractions to the risk factor were reduced to the counterfactual distribution. The alternative (counterfactual) scenario used is the exposure distribution that would result in the lowest population risk, referred to as the theoretical-minimumrisk exposure distribution (Ezzati and others 2002; Murray and Lopez 1999). For example, some deaths from childhood pneumonia may have been avoided by preventing exposure to indoor smoke from household use of solid fuels, childhood underweight, and zinc deficiency (which itself affects weight-for-age); and some cardiovascular disease events may be due to a combination of smoking, physical inactivity, and low fruit and vegetable intake. The work included collecting primary data and undertaking a number of reanalyses of original data, systematic reviews, and meta-analyses. To increase comparability while acknowledging the fundamental differences in exposure and hazard quantification across risk factors, the criteria for using the scientific evidence included consistency of exposure variables used in exposure data sources with those used in epidemiological studies on hazard, population representativeness of exposure data, and study design for estimating the magnitude of hazardous effects (including minimizing the effects of confounders). Data sources, models, and assumptions used to extrapolate exposure or relative risk across countries or regions are described in detail in chapters devoted to individual risk factors elsewhere (Ezzati and others 2004). External reviewers anonymously peer reviewed each risk factor chapter, including conducting re-reviews as appropriate. In this reanalysis, estimates of mortality and disease burden attributable to risk factors were needed in World Bank regions (see map 1 inside the front cover). For six risk factors (childhood underweight, high blood pressure, high cholesterol, overweight and obesity, smoking, and indoor smoke from household use of solid fuels), country-level data were available and allowed reestimating exposure directly for World Bank regions. Theoretical-Minimum-Risk Exposure Distributions the theoretical-minimum-risk exposure distribution was zero for risk factors for which zero exposure could be defined and reflected minimum risk, such as no smoking. For the latter risk factors, we used the lowest levels observed in specific populations and epidemiological studies to choose the theoretical-minimum-risk exposure distribution. For example, counterfactual exposure distributions of 115 mmHg for systolic blood pressure and 3. Alcohol has benefits as well as causing harm for different diseases depending on the disease and on patterns of alcohol consumption (Corrao and others 2000; Puddey and others 1999). This was because despite its benefits for cardiovascular diseases in some populations, the global and regional burden of disease due to alcohol use was dominated by its impacts on neuropsychiatric diseases and injuries that are considerably larger than these benefits. Finally, for factors with protective effects, namely, fruit and vegetable intake and physical activity, we chose a counterfactual exposure distribution based on a combination of levels observed in high-intake populations and the level to which the benefits may continue given current scientific 246 Global Burden of Disease and Risk Factors Majid Ezzati, Stephen Vander Hoorn, Alan D. The leading causes of mortality and the disease burden include risk factors for communicable, maternal, perinatal, and nutritional conditions (Group I as defined in chapter 3), such as undernutrition; indoor smoke from household use of solid fuels; unsafe water, sanitation, and hygiene, whose burden is primarily concentrated in low-income regions of South Asia and Sub-Saharan Africa; and unsafe sex. Undernutrition is the single leading global cause of health loss, as it was in 1990 (the 2001 results disaggregate undernutrition into underweight and micronutrient deficiencies). Even though the prevalence of underweight has decreased in most regions in the past decade, it has increased in Sub-Saharan Africa (de Onis, Frongilla, and Blossner 2000; de Onis and others 2004), where its effects are disproportionately large because of simultaneous exposure to other risk factors for childhood disease. The burden of disease attributable to unsafe water, sanitation, and hygiene has declined since 1990, mostly because of a worldwide decline in mortality from diarrheal disease, which is partly a result of improved case management interventions, particularly oral rehydration therapy. The increase in the global burden of disease attributable to smoking since 1990 mostly reflects the increased accumulated hazards of this risk, which is most noticeable in developing countries, but the increase is also partially due to methodological changes based on new evidence on the magnitude of the hazard after correction for confounding (Ezzati, Henley, Lopez, and others 2005; Ezzati, Henley, Thun, and others 2005; Ezzati and Lopez 2003; Thun, Apicella, and Henley 2000). The large increase in the burden of disease due to high blood pressure is likely to be an outcome of major methodological improvements, that is, relative risks that account for regression dilution bias and choice of theoretical-minimum-risk exposure distribution based on epidemiological evidence versus clinical definitions. The disease burden attributable to underweight and micronutrient deficiencies in children was equally distributed among males and females, but the total all-age disease burden from iron and vitamin A deficiencies was slightly greater among females because of the effects on maternal mortality and morbidity conditions. Other diet-related risks, physical inactivity, environmental risks, and unsafe sex contributed almost equally to the disease burden in males and females. Approximately 77 to 86 percent of the disease burden from addictive substances occured among men, reflecting the social and economic forces that have so far made addictive substances more widely used by men, especially in developing countries. Women suffered an estimated twothirds of the disease burden from child sexual abuse and all of the burden caused by non-use and use of ineffective methods of contraception. The estimated disease burdens from childhood undernutrition and unsafe water, sanitation, and hygiene were almost exclusively among children under five years of age. For these risks, more than 90 percent of the total attributable burden occurred in this age group, with the exception of iron deficiency, where adults bore more than 40 percent of burden, especially women of childbearing age.
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Some pathogens (including Ebola) have emerged from wildlife reservoirs and entered into human populations through the hunting and consumption of wild species (such as bushmeat) menstrual calendar symbian generic fluoxetine 20mg with amex, the wild animal trade menstrual cycle 8 days apart cheap 20mg fluoxetine visa, and other contact with wildlife (Pike and others 2010; Wolfe menopause 87 best 20mg fluoxetine, Dunavan women's health clinic eagle river alaska cheap fluoxetine 10 mg mastercard, and Diamond 2007). Zoonotic pathogens vary in the extent to which they can survive within and spread between human hosts. Most zoonotic pathogens are not well adapted to humans (stages 23), emerge sporadically through spillover events, and may lead to localized outbreaks, called stuttering chains (Pike and others 2010; Wolfe and others 2005). These episodes of "viral chatter" increase pandemic risk by providing opportunities for viruses to become better adapted to spreading within a human population. Pathogens that are past stage 3 are of the greatest concern, because they are sufficiently adapted to humans to cause long transmission chains between humans (directly or indirectly through vectors), and their geographic spread is not constrained by the habitat range of an animal reservoir. Pandemic Risk Factors Pandemic risk, as noted, is driven by the combined effects of spark risk and spread risk. Spark Risk A zoonotic spark could arise from the introduction of a pathogen from either domesticated animals or wildlife. Zoonoses from domesticated animals are concentrated in areas with dense livestock production systems, including areas of China, India, Japan, the United States, and Western Europe. Key drivers for spark risk from domesticated animals include intensive and extensive farming and livestock production systems and live animal markets, as well as the potential for contact between livestock and wildlife reservoirs (Gilbert and others 2014; Jones and others 2008). Wildlife zoonosis risk is distributed far more broadly, with foci in China, India, West and Central Africa, and the Amazon Basin (Jones and others 2008). Risk drivers include behavioral factors (such as bushmeat hunting and use of animal-based traditional medicines), natural resource extraction (such as sylviculture and logging), the extension of roads into wildlife habitats, and environmental factors (including the degree and distribution of animal diversity) (Wolfe and others 2005). Spread Risk After a spark or importation, the risk that a pathogen will spread within a population is influenced by pathogenspecific factors (including genetic adaptation and mode of transmission) and human population-level factors (such as the density of the population and the susceptibility to infection; patterns of movement driven by travel, trade, and migration; and speed and effectiveness of public health surveillance and response measures) (Sands and others 2016). Pandemics: Risks, Impacts, and Mitigation 319 Dense concentrations of population, especially in urban centers harboring overcrowded informal settlements, can act as foci for disease transmission and accelerate the spread of pathogens (Neiderud 2015). Moreover, social inequality, poverty, and their environmental correlates can increase individual susceptibility to infection significantly (Farmer 1996). Collectively, all these factors suggest that marginalized populations, including refugees and people living in urban slums and informal settlements, likely face elevated risks of morbidity and mortality during a pandemic. The index illustrates global variation in institutional readiness to detect and respond to a large-scale outbreak of infectious disease. Well-prepared countries have effective public institutions, strong economies, and adequate investment in the health sector. They have built specific competencies critical to detecting and managing disease outbreaks, including surveillance, mass vaccination, and risk communications. Poorly prepared countries may suffer from political instability, weak public administration, inadequate resources for public health, and gaps in fundamental outbreak detection and response systems. A geographic analysis of preparedness shows that some areas of high spark risk also are the least prepared. However, geographic areas with high spark risk from wildlife species (including Central and West Africa) have some of the lowest preparedness scores globally, indicating a potentially dangerous overlap of spark risk and spread risk. National income alone offers an incomplete and potentially misleading metric of preparedness. Although income is correlated with epidemic preparedness, many countries are substantially better or worse prepared than expected, given their gross national income per capita. Burden of Pandemics Quantifying the morbidity and mortality burden from pandemics poses a significant challenge. To overcome these gaps in estimating the frequency and severity of pandemics, probabilistic modeling techniques can augment the historical record with a large catalog of hypothetical, scientifically plausible, simulated pandemics that represent a wide range of possible scenarios. Modeling can also better account for changes that have occurred since historical times, such as medical advances, changing demographics, and shifting travel patterns. Scenario modeling of epidemics and pandemics can be achieved through large-scale computer simulations of global spread, dynamics, and illness outcomes of disease (Colizza and others 2007; Tizzoni and others 2012). These models allow for specification of parameters that may drive the likelihood of a spark (for example, location and frequency) and determinants of severity (for example, transmissibility and virulence).
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