By X. Merdarion. Mississippi Valley State University. 2019.

The company s focus signifcantly increased the number of its prod- areas include public health initiatives purchase 25 mg unisom otc, increasing ucts with equitable pricing strategies purchase 25mg unisom visa, taking New public commitment not to fle patents order 25mg unisom overnight delivery. However, only a third er-middle income countries and upper-middle (31%) of its products have pricing strategies that income countries that together cover 70% of Best practice: manufacturing capacity build- target some priority countries (disease-specifc countries within the scope of the Index. Rather than training sub-sets of countries with a particular need for individual manufacturers, AstraZeneca provides access to relevant products). New commitment to licensing, with clear funding, training and other support to Tianjin exceptions. Although AstraZeneca has not yet University to fll local manufacturing skills gaps. Registration behaviour lags behind advances in licensed a product, it has now set out the situa- Via the university, the company s expertise can pricing. Its policy be shared more widely, to help improve manu- of disease-specifc registration targets. It does excludes licences for products for non-commu- facturing safety standards at the industry level not publish where its products are registered or nicable diseases in lower-middle income coun- in China. The company has fled to permits supply to Least Developed Countries, Innovation: building capacity through Healthy register some (40%) of its newest products in low-income countries and lower-middle income Heart Africa. In 2014, AstraZeneca launched just a few (6%) priority countries (disease-spe- countries. It acknowledges based training for health-workers, and targeted that countries have the right to determine what supply chain management support. For its Healthy Innovation: scale-up of Young Health Heart Africa programme, in East African mar- Patent status disclosure. AstraZeneca has scaled up its kets, AstraZeneca has developed new artwork lishes the status of all patents it holds for high- Young Health Programme. The programme for felodipine (Plendil ), lisinopril (Zestril ) and need products in the high-burden countries focuses on preventing non-communicable dis- lisinopril/hydrochlorothiazide (Zestoretic ), measured by the Index, including publishing the ease among adolescents. AstraZeneca s intra-country equi- for patents, where it is prepared to license, and table pricing strategy for ticagrelor (Brilinta ) for which products, and gives an indication of Drops four places. This strategy is particularly important AstraZeneca donations are covered within the as ticagrelor is a frst-line therapy in the preven- Active in all areas of capacity building, targets AstraZeneca Global Guidance Procedure and tion of atherothrombotic events, is on patent, local needs. This has shaped its new pricing pliant with its regulations to ensure products are policy and will continue to do so in the future. Focus on Kenya for strengthening supply chains donated appropriately and as represented. AstraZeneca company also requires quarterly reports from Centre of Excellence and trains international focuses on Kenya, through its Healthy Heart partner organisations. Africa programme, to build local supply chain management and pharmacovigilance capac- Involved in humanitarian aid programmes. Strong approach to philanthropy that meets AstraZeneca is the largest riser, climbing ten local needs. It solid compliance processes protect it from breaching laws does not, for example, clearly make sales agents accounta- and regulations on unethical behaviour. As such, insight into its progress and local needs and capacity gaps into account. This could can rigorously monitor and evaluate the drug Improve clinical trial transparency. Gilead lags help address the increasing burden of these con- donation programme it has initiated in Georgia, behind the industry in this area. The company can also introduce a mech- including more high-prevalence middle income socio-economic factors in its inter-country equi- anism for sharing anonymised patient-level data countries in the terms of its hepatitis C licens- table pricing strategies, to help ensure products with third parties. Gilead Ethics, Gilead discloses the details of its policy only company in the industry that does not have falls three places, despite having a range of for managing conficts of interest. It does not publish information No breaches of laws or codes of conduct gov- level data on request. As in 2014, Gilead has not been the subject of any settlements for Does not share intellectual property. It has a centralised employees must undergo training in this respect Gilead drops six places, but remains among the performance management system with quar- and understand all the various elements of the leaders. Low transparency on stakeholder engagement Business Partner Compliance Pocket Guide, It is less transparent than in 2014 about its vol- strategy and activities. Gilead has a clear stake- which addresses a range of interactions with umes of sales, which means there is little evi- holder engagement strategy, but does not pro- physicians and government ofcials. Gilead dence for the implementation of its pricing vide information regarding the stakeholder ofers compliance training, featuring case-based strategies. Its inter-country equitable pricing engagement activities of its branch organisa- scenarios, to business partners across multi- strategies only consider a few socio-economic tions. Gilead s relevant pipeline is smaller than ister half (50%) of its newest products in a few strong compliance system, including guidance the industry average, and it falls below indus- priority countries (disease-specifc sub-sets and contractual obligations to contractors. In an try standards for clinical trial conduct and clinical of countries with a particular need for access innovative move, the company has developed a data transparency. Gilead has an ethical marketing ted to conducting R&D for resource-limited set- Monitors prices and provides pricing guidelines code that also applies to third parties, but it has tings. For its hepatitis C prod- marketing activities and payments in countries ucts, the company sets pricing guidance for its within scope. The company is not a signatory to Poor measures to ensure clinical trials are con- sales agents via transfer prices. Despite having policies in place to ensure ethical clinical trial conduct, Gilead Consistent recall guidelines. Gilead has glob- Publicly discloses policy positions and con- does not provide evidence that it monitors clin- ally consistent guidelines for issuing drug recalls fict of interest policy. Gilead publishes its policy ical trial conduct or takes disciplinary action in all countries relevant to the Index where its positions related to access, in particular those when ethical violations occur. Gilead has not recalled 110 Access to Medicine Index 2016 a product for a relevant disease in a country in all of its hepatitis C portfolio. Notably, it did so Monitoring mainly the responsibility of part- scope during the period of analysis. Gilead contractually requires that donation it does make recall information publicly available. The com- fovir disoproxil fumarate and efavirenz/emtric- environmental conditions, demographic or cul- pany builds manufacturing capacity in coun- itabine/tenofovir disoproxil fumarate each year tural needs. In April 2015, Gilead launched an with equitable pricing strategies that target the capacity. Gilead makes a general commitment innovative donation programme with the goal of majority of priority countries (disease-specifc to building manufacturing capacity in relevant eliminating hepatitis C virus in Georgia. In the period of analysis, the com- gramme includes universal screening and treat- to relevant products). Together, these strategies pany undertook a number of technology trans- ment, prevention and surveillance. Gilead now has more products with equitable will provide 20,000 free courses of sofosbuvir/ pricing strategies than in 2014.

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The first is the interaction between two major demographic trends buy unisom 25 mg on line, as illustrated in figure 2 purchase 25 mg unisom. Most Pacific countries have relatively high total fertility rates and low contraceptive prevalence rates that are more akin to the global average for least developed countries order unisom 25 mg fast delivery. In figure 2, the absolute population growth is largely driven by Papua New Guinea, but the trends are similar for most Pacific countries. In addition, the share of those aged 60 and older 2 has begun to increase and is expected to grow very rapidly in the coming years. Dietary risk factors also constitute the highest behavioral risk factors for death due to diabetes. Low physical activity imposes significant risk of death caused by cardiovascular diseases, diabetes, and cancer. Tobacco smokers lose at least one decade of life expectancy compared to those who never smoked (Jha et al. Tonga and Samoa have the highest obesity rates (58 percent and 54 percent, respectively). School age obesity and overweight percentages are also high in many countries (Anderson, 2013a). Other trends and risk factors also point to a substantial worsening of the situation. The share of public health expenditure is growing for most countries in the Pacific, raising questions about long-term financial sustainability. This pattern is consistent with the global trend in which most countries increase public health expenditure as their economies and financial resources 6 grow. All of this raises the question as to whether the expansion of public health expenditure as a share of the economy is financially sustainable. Health expenditure is already absorbing a significant and growing share of government expenditure. Thus, the financial and political sustainability of continuing increasing public expenditure in health become very important. To put this chart in perspective, it is worth noting that only nine of 61 countries in Sub-Saharan Africa with high health burdens allocate 15 percent of government expenditure to the health sector, a goal set as part of the Abuja Declaration in 2001. Four countries in the Pacific have exceeded that percentage, and all countries in the Pacific exceed the global public health expenditure average of 6. Several countries therefore support overseas referrals to Australia, Fiji, New Zealand, India or elsewhere to receive specialized medical care. The government usually pays for the travel, as well as hospital and treatment costs (which can be for an extended period) of the patient and, in some instances, accompanying family members. The public policy and public financing challenge is to ensure such schemes are cost-effective compared to alternative use of the finances. The effective management of these programs is difficult, especially for smaller island countries. Recent research (details available on request) found that over one-third of the government health budget can be allocated to overseas referrals for the benefit of around one percent of the population. An earlier study by the Ministry of Health in Samoa noted that the overseas treatment program absorbed 15 percent of total public health expenditure in 2009/10, to the private benefit of less than 0. The overseas treatment program absorbed 11 percent of total public health funding in 2008/09, and this had grown to 15 percent by 2009/10. Diabetes is usually a life-long disease and can have disabling complications including blindness and amputations. In brief, government funding for diabetes-related insulin was simply unaffordable and unsustainable. While dialysis clinics in the Pacific are generally less expensive than overseas referrals, dialysis raises some fundamental questions about the affordability and financial sustainability of dialysis treatment in the Pacific context (see Box 1). This raises questions of equity and opportunity cost as other, higher impact interventions could be provided for the amount of resources currently allocated to dialysis patients. It is difficult to determine the gender and socio-economic profile of the 116 patients or whether there is equitable access to dialysis treatment from public sources. Finally, and importantly, the overall affordability and financial sustainability of the dialysis 9 program is questionable. Source: National Kidney Foundation of Samoa Annual Report 2013/14 and 2014/15 (National Kidney Foundation of Samoa, 2015). If young children are taken out of school to look after a relative with diabetic blindness then the possibility for the next generation to improve their own living standards is compromised. There are particularly adverse long-term social effects if young girls are taken out of school to look after sick relatives (Hill & King, 1995). This is a particular problem in Asia where out-of- pocket expenditures are high, and can lead to impoverishment. Out-of-pocket expenditure is much less of a problem in the Pacific where government health expenditure absorbs most of the burden. Kiribati, Samoa, and Solomon Islands are near to the middle-income average burden in 2030. Due to lack of data, estimates for the five smaller Pacific nations required more assumptions. The paucity of age disaggregated labor force participation rates required the assumption that these five countries, for which only aggregated labor force participation rates are available, assume the average disaggregation rate for the countries with available data. This average was calculated based on Fiji, Samoa, Solomon Islands, Tonga and Vanuatu. Papua New Guinea was excluded due to its resources driven economic profile 2 compared with all other 10 countries included in the Pacific Possible study. Cardiovascular disease accounts for the greatest mortality burden in the Pacific Islands, followed by diabetes. Cardiovascular disease is projected to account for 43 percent of lost economic output in the 11 Pacific countries, compared with 51 percent globally. However, diabetes contributes a far greater economic burden at nearly one quarter (24 percent) of lost economic output, on average, compared to the global share of just 6 percent. This is partly due to the relatively high incidence and prevalence of diabetes in the Pacific. Of the 11 countries analyzed, in 2040, Fiji will suffer the highest cardiovascular burden at roughly 60 percent. In 2040, Vanuatu will suffer the highest diabetes burden at roughly 38 percent, even higher than the burden from cardiovascular disease. Again, cardiovascular disease will have the greatest impact, causing an especially high amount of lost labor in Fiji and Micronesia. Diabetes is especially severe in Vanuatu, which has almost double the burden than any of the other countries. It should be noted this is the estimated overall potential labor loss to the labor force, not the employed labor force. Thus higher employment levels will be associated with greater potential economic loss. In another words, the actual economic loss may be less if there is high unemployment or under-employment.

Still other allergens are known only as complex mixtures of proteins and polypeptides with varying amounts of carbohydrate generic 25 mg unisom amex. Details of the chemistry of known allergens are described under their appropriate headings ( 2) generic 25 mg unisom free shipping. The methods of purifying and characterizing allergens include biochemical buy cheap unisom 25mg, immunologic, and biologic techniques. The methods of purification involve various column fractionation techniques, newer immunologic techniques such as the purification of allergens by monoclonal antibodies, and the techniques of molecular biology for synthesizing various proteins. All of these purification techniques rely on sensitive and specific assay techniques for the allergen. Aeroallergens are named using nomenclature established by an International Union of Immunologic Societies subcommittee: the first three letters of the genus, followed by the first letter of the species and an Arabic numeral ( 3). Commonly encountered allergens For a particle to be clinically significant as an aeroallergen, it must be buoyant, present in significant numbers, and allergenic. Fungal spores are ubiquitous, highly allergenic, and may be more numerous than pollen grains in the air, even during the height of the pollen season. The above allergens are emphasized because they are the ones most commonly encountered, and they are considered responsible for most of the morbidity among atopic patients. Others may be associated with occupational exposures, as is the case in veterinarians who work with certain animals (e. Some sources of airborne allergens are narrowly confined geographically, such as the mayfly and the caddis fly, whose scales and body parts are a cause of respiratory allergy in the eastern Great Lakes area in the late summer. In addition, endemic asthma has been reported in the vicinity of factories where cottonseed and castor beans are processed. Airborne pollens are in the range of 20 to 60 m in diameter; mold spores usually vary between 3 and 30 m in diameter or longest dimension; house dust mite particles are 1 to 10 m. Protective mechanisms in the nasal mucosa and upper tracheobronchial passages remove most of the larger particles, so only those 3 m or smaller reach the alveoli of the lungs. Hence, the conjunctivae and upper respiratory passages receive the largest dose of airborne allergens. These are considerations in the pathogenesis of allergic rhinitis, bronchial asthma, and hypersensitivity pneumonitis as well as the irritant effects of chemical and particulate atmospheric pollutants. The development of asthma after pollen exposure is enigmatic because pollen grains are deposited in the upper airways as a result of their large particle size. Experimental evidence suggests that rhinitis, but not asthma, is caused by inhalation of whole pollen in amounts encountered naturally ( 4). Asthma caused by bronchoprovocation with solutions of pollen extracts is easily achieved in the laboratory, however. Pollen asthma may be caused by the inhalation of pollen debris that is small enough to access the bronchial tree. Extracts of materials collected on an 8- m filter that excludes ragweed pollen grains induced positive skin test results in ragweed-sensitive subjects. Using an immunochemical method of identifying atmospheric allergens, Amb a 1 was found to exist in ambient air in the absence of ragweed pollen grains ( 6). Positive bronchoprovocation was induced with pollen grains that had been fragmented in a ball mill, but was not induced by inhalation of whole ragweed pollen grains ( 7). Exposure of grass pollen grains to water creates rupture into smaller, respirable size starch granules with intact group V allergens ( 8), possibly explaining the phenomenon of thunderstorm asthma during grass pollen seasons (9,10). However, despite the generally accepted limitations previously mentioned, examination of tracheobronchial aspirates and surgical lung specimens has revealed large numbers of whole pollen grains in the lower respiratory tract ( 11). Another consideration is the rapidity with which various allergens are leached out of the whole pollen grains. The mucous blanket of the respiratory tract has been estimated to transport pollens into the gastrointestinal tract in less than 10 minutes. The allergens of grass pollens and ragweed Amb a 5 are extracted rapidly from the pollen grains in aqueous solutions and can be absorbed through the respiratory mucosa before the pollen grains are swallowed. Ragweed Amb a 1, however, is extracted slowly, and only a small percentage of the total extractable Amb a 1 is released from the pollen grain in this time frame ( 12). This observation has not been reconciled with the presumed importance of Amb a 1 in clinical allergy, but absorption may be more rapid in the more alkaline mucus found in allergic rhinitis ( 13). The enzymatic activity of Der p 1 helps the allergen to penetrate through the respiratory mucosa and helps to promote an IgE response as described in detail later in this chapter. A similar study performed on fungal proteases also suggests the importance of enzymatic activity in the development of an allergic response ( 14). Sampling Methods for Airborne Allergens Increasing attention is being focused on the daily levels of airborne allergens detected in a particular locale. Patients commonly seek out daily reports of ragweed or Alternaria levels, frequently reported in newspapers and on television, to correlate and predict their allergy symptoms. The clinician must be acquainted with the various sampling techniques used to accurately assess the validity and accuracy of the readings reported. Aerobiologic sampling attempts to identify and quantify the allergenic particles in the ambient atmosphere, both outdoors and indoors. Commonly, an adhesive substance is applied to a microscope slide or other transparent surface, and the pollens and spores that stick to the surface are microscopically enumerated. Devices of varying complexity have been used to reduce the most common sampling errors relating to particle size, wind velocity, and rain. Although many laboratories use various immunoassays to identify and quantify airborne allergens, the microscopic examination of captured particles remains the method of choice. Gravitational samplers were used historically, but are rarely used today because they provide qualitative data without quantitative data. Impaction Samplers Impaction samplers currently are the most common types of pollen samplers in use. The principle is that wind speed usually is greater than the rate of gravitational settling. Small particles carried by the wind have an inertial force that causes them to impact on an adhesive surface. Small surface areas, however, are rapidly overloaded, causing a decrease in the efficiency of capture. The rotating impaction sampler has two vertical collecting arms mounted on a crossbar, which is rotated by a vertical motor shaft. The speed of rotation is up to several thousand revolutions per minute and is nearly independent of wind velocity. These samplers usually are run intermittently (20 60 seconds every 10 minutes) to reduce overloading. In some models, the impacting arms are retracted or otherwise protected while not in use. Although suitable for pollens, they are more commonly used to measure smaller particles such as mold spores.

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