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Schiff explicates the numerous barriers errors in medical practice buy 2 mg artane with mastercard back pain treatment upper, especially in medical diagnosis order artane 2 mg without prescription pain relief treatment. Graber identifies stakeholders convincingly demonstrate that we physicians lack strong interested in medical diagnosis and provides recommenda- direct and timely feedback about our decisions buy 2mg artane otc pain medication for dogs after neuter. The ex- other words order generic artane pain treatment center west hartford ct, the average day does not confront us with our ception is the case already recognized to be miserably com- errors. Its purpose was to increase the likelihood that decision making as it relates to diagnostic error and over- the correct diagnosis appeared on the list of differential confidence, which is expanded upon by their colleagues. Pat Croskerry and Geoff Norman ingly apt (and offered free of charge by Missouri Regional review 2 modes of clinical reasoning in an effort to better Medical Program), the system produced many astonishing understand the processes underlying overconfidence. Wears highlight gaps in garding “tough” cases, but no rush to employment or major knowledge about the nature of diagnostic problems, empha- changes in mortality rates. Clearly, many experts are con- these present efforts to study diagnostic decision making cerned about these processes. In closing, I applaud espe- professional or lay reader who thinks it is easy to bring cially the suggestions to systematize the incorporation of the medical decision making closer to the ideal. Schiff in lems likely will not get better until the average day does the fourth commentary, “Learning and feedback are insep- confront us with our errors. This analytic review concerns the exceptions: the times when these cognitive processes fail and the final diagnosis is missed or wrong. We argue that physicians in general underappreciate the likelihood that their diagnoses are wrong and that this tendency to overconfidence is related to both intrinsic and systemically reinforced factors. We present a comprehensive review of the available literature and current thinking related to these issues. The review covers the incidence and impact of diagnostic error, data on physician overconfidence as a contributing cause of errors, strategies to improve the accuracy of diagnostic decision making, and recommendations for future research. In that survey, 35% 1 —Fran Lowry experienced a medical mistake in the past 5 years involving 2 themselves, their family, or friends; half of the mistakes were Mongerson describes in poignant detail the impact of a described as diagnostic errors. Interestingly, 55% of respondents listed veys of patients have shown that patients and their physi- misdiagnosis as the greatest concern when seeing a physician cians perceive that medical errors in general, and diagnostic in the outpatient setting, while 23% listed it as the error of most errors in particular, are common and of concern. Concerns about medical errors stance, Blendon and colleagues surveyed patients and phy- also were reported by 38% of patients who had recently visited sicians on the extent to which they or a member of their an emergency department; of these, the most common worry family had experienced medical errors, defined as mistakes 5 was misdiagnosis (22%). For this reason, we have Statement of author disclosures: Please see the Author Disclosures reviewed the scientific literature on the incidence and im- section at the end of this article. Department of Health Services Administration, School of Health Profes- In the latter portion of this article we review the literature on sions, University of Alabama at Birmingham, 1675 University Boulevard, Room 544, Birmingham, Alabama 35294-3361. In 1 such generally lowest for the 2 perceptual specialties, radiology study, the pathology department at the Johns Hopkins Hos- and pathology, which rely heavily on visual interpretation. A similar study at ology and anatomic pathology probably range from 2% to Hershey Medical Center in Pennsylvania identified a 5. The typically low error rates in these specialties should not be expected in those practices in tissues from the female reproductive tract and 10% in and institutions that allow x-rays to be read by frontline cancer patients. Certain tissues are notoriously difficult; for clinicians who are not trained radiologists. For example, in example, discordance rates range from 20% to 25% for 21,22 a study of x-rays interpreted by emergency department lymphomas and sarcomas. A study of admissions to dance rate in practice seems to be 5% in most British hospitals reported that 6% of the admitting diag- 25,26 cases. The emergency department requires Mammography has attracted the most attention in re- complex decision making in settings of above-average un- gard to diagnostic error in radiology. The rate of diagnostic error in this arena variability from one radiologist to another in the ability to 14,15 ranges from 0. A recent study of breast cancer found that the nostic error in clinical medicine was approximately 15%. In diagnosis was inappropriately delayed in 9%, and a third this section, we review data from a wide variety of sources 29 of these reflected misreading of the mammogram. Several studies have ex- frequently recommending biopsies for what turn out to be amined changes in diagnosis after a second opinion. Given the differences regarding insurance 17 coverage and the medical malpractice systems between and associates, using telemedicine consultations with spe- cialists in a variety of fields, found a 5% change in diagno- the United States and the United Kingdom, it is not sis. There is a wealth of information in the perceptual surprising that women in the United States are twice as specialties using second opinions to judge the rate of diag- likely as women in the United Kingdom to have a neg- 30 nostic error. It is important to emphasize that only a fraction of the 18,27,31–46 studies that have measured the rate of diagnos- discordance in these studies was found to cause harm. An unsettling consistency emerges: the frequency of diagnostic error is disappoint- Dermatology. For exam- tions and disorders where rapid and accurate diagnosis is ple, in a study of 5,136 biopsies, a major change in diag- essential, such as myocardial infarction, pulmonary em- nosis was encountered in 11% on second review. Of6 at ien t w ho died o fp ulm o n ar y em b o li m , he diagn o s i w as n o t us ect ed clin ically in L eder le et al( up ur ed ao r ic an eur ys m eview o fallcas es at a in gle m edicalcen t er o ver a yr er io d. Of2 cas es in vo lvin g ab do m in alan eur ys m s vo n o do li ch et al diagn o s i o fr up ur ed an eur ys m w as in iially m i ed in in at ien t es en t in g w ih ches ain , ( diagn o s i o fdi ect in g an eur ys m o ft he p o xim alao r a w as m i ed in o fcas es E dlo w Sub ar achn o id hem o r hage Up dat ed eview o fp ub li hed udies o n ub ar achn o id hem o r hage: ar e m i diagn o s ed o n in iialevaluat io n B ur o n et al( an cer det ect io n ut o p y s udy at a in gle ho s ial o ft he 2 m align an t n eo p las m s fo un d at aut o p y, w er e eiher m i diagn o s ed o r un diagn o s ed, an d in o ft he cas es he caus e o fdeat h w as judged o b e r elat ed o he can cer B eam et al( eas can cer accr edied cen t er agr eed o eview m am m o gr am s o f7 w o m en , o fw ho m had b r eas can cer he can cer w o uld have b een m i ed in M cG in n i et al( elan o m a Seco n d eview o f5 b io p y s am p les diagn o s i chan ged in fo m b en ign o m align an t fo m m align an t o b en ign , an d had a chan ge in um o r gr ade) Per li i o lar di o r der The in iialdiagn o s i w as w r o n g in o fp at ien t w ih b i o lar di o r der an d delays in es ab li hin g he co r ect diagn o s i w er e co m m o n G affet al( en dicii et o s ect ive s udy at ho s ial o fp at ien t w ih ab do m in alp ain an d o p er at io n s fo r ap en dicii Of1 p at ien t w ho had ur ger y, her e w as n o ap en dicii in o f9 at ien t w ih a fin aldiagn o s i o f ap en dicii he diagn o s i w as m i ed o r w r o n g in R aab et al( an cer at ho lo gy The feq uen cy o fer o r in diagn o s in g can cer w as m eas ur ed at ho s ial o ver a yr er io d. The autopsy has been described as “the What Percentage of Adverse Events is 47 most powerful tool in the history of medicine” and the Attributable to Diagnostic Errors and What “gold standard” for detecting diagnostic errors. Richard Percentage of Diagnostic Errors Leads to Cabot correlated case records with autopsy findings in Adverse Events? In the Harvard Medical Practice Study of tween clinical and autopsy diagnoses were found in a 30,195 hospital records, diagnostic errors accounted for more recent study of geriatric patients in the Nether- 58,59 50 17% of adverse events. On average, 10% of autopsies revealed that the study of 15,000 records from Colorado and Utah reported clinical diagnosis was wrong, and 25% revealed a new that diagnostic errors contributed to 6. Using the same methodology, the Canadian a fraction of these discrepancies reflected incidental find- Adverse Events Study found that 10. The Qual- crepancies that potentially could have changed the out- ity in Australian Health Care Study identified 2,351 ad- come were found in approximately 10% of all verse events related to hospitalization, of which 20% 32,51 autopsies. A large study in New Zealand examined 6,579 cause the diagnostic error rate is almost certainly lower inpatient medical records from admissions in 1998 and among patients with the condition who are still alive, found that diagnostic errors accounted for 8% of adverse 63 error rates measured solely from autopsy data may be events; 11. That is, clinicians are attempting to make the diagnosis among living patients before death, so the more Error Databases. Although of limited use in quantifying relevant statistic in this setting is the sensitivity of clin- the absolute incidence of diagnostic errors, voluntary error- ical diagnosis. For example, whereas autopsy studies reporting systems provide insight into the relative incidence suggest that fatal pulmonary embolism is misdiagnosed of diagnostic errors compared with medication errors, treat- approximately 55% of the time (see Table 1), the misdi- ment errors, and other major categories. Out of 805 volun- agnosis rate for all cases of pulmonary embolism is only tary reports of medical errors from 324 Australian physi- 32 cians, there were 275 diagnostic errors (34%) submitted 4%. Shojania and associates argue that a large discrep- 64 ancy also exists regarding the misdiagnosis rate for myo- over a 20-month period. Compared with medication and treatment errors, diagnostic errors were judged to have cardial infarction: although autopsy data suggest roughly caused the most harm, but were the least preventable. A 20% of these events are missed, data from the clinical smaller study reported a 14% relative incidence of diagnos- setting (patients presenting with chest pain or other rel- tic errors from Australian physicians and 12% from physi- evant symptoms) indicate that only 2% to 4% are missed. Mandatory error-reporting sys- tems that rely on self-reporting typically yield fewer error reports than are found using other methodologies. One method of test- ample, only 9 diagnostic errors were reported out of almost ing diagnostic accuracy is to control for variations in case 1 million ambulatory visits over a 5.

Tobacco and alcohol are generally the most commonly used drugs amongst South African youth purchase artane 2 mg visa pain management for shingles pain. Although polysubstance abuse is common in South Africa discount artane 2mg otc brunswick pain treatment center brunswick ga, cannabis is the most commonly used illicit substance amongst youth (Peltzer 2003) generic artane 2mg mastercard pain treatment for cancer. A study by Reddy et al in 2010 reported that 12% of South African learners had ever used at least one illegal drug such as heroin discount 2 mg artane unifour pain treatment center denver nc, mandrax and cocaine. Given the medical and social harm caused by these drugs, it is important to understand the extent of their use amongst sub populations and explore the effective ways to combat them. Statistics reported by the United Nations World Drug Report of 2014 indicates that 7. Substance abuse imposes social, health and economic costs on individuals, families, society and economy at large. At the individual level, substance abuse has been linked to depression, violent behaviour and various forms of crime, including many accidental and premeditated injuries. Society loses the productivity and energies of people affected by substance abuse. At the macro level, prevention and treatment costs associated with drug abuse are phenomenal. In South Africa, evidence on the extent, impact of substance abuse as well as its prevention is fragmented and more often not located within a comprehensive theoretical framework that could make it easier to formulate strategies and programmes for combating the drug abuse challenge. Although much research has been done on the subject, little attempt has been done to put all this evidence in a coherent narrative that will put to the fore the extent, and impact of the problem and inform future interventions and the designing of programmes. The objective of this paper is to provide a coherent report on the extent and impact as well as substance abuse intervention programmes within South Africa’s youth population group. The report is wholly based on a comprehensive review of literature on substance abuse in South Africa. The literature search revealed some major gaps in the availability of credible and reliable information on drug abuse. Attempting to define the problem from a young women’s perspective was even more challenging as there is very little primary research conducted in this field. Notwithstanding 4 this, the paper found some valuable papers which have been used to synthesise this document. The United Nations Office on Drugs and Crime has some presence in South Africa through the United Nations Office on Drugs and Crime Southern Africa office. Its drug related mandate includes strengthening the legislative and judicial capacity to ratify and implement international conventions and instruments on drug control, organized crime, corruption, terrorism and money-laundering; reducing drug trafficking; and enhancing the capacity of government institutions and civil society organizations to prevent drug use and the spread of related infections. The main piece of national legislation addressing substance use is the 2008 Prevention of, and Treatment for Substance Abuse Act. The Act provides, among other things, a comprehensive response to combating substance abuse, and offers mechanisms for addressing substance abuse. Section 1 of the Act provides a framework for responding to substance abuse, while Section 2 provides strategies for reducing harm. The Act has been the basis of South Africa’s many programs and strategies for combating substance abuse. The Prevention of, and Treatment for Substance Abuse Act is supported by the Drug Master Plan 2013-17, which sets out the strategies and measures to be used to combat substance abuse. Interventions proposed in the Plan are based on the supply and demand framework, i. Other pieces of legislation relevant (see Table 1) in combating substance abuse include the Liquor Act of 2003, the Tobacco Products Control Amendment Act of 1999, the Road Traffic Amendment Act of 1998, and the Prevention of Organised Crime Act of 1998. In the provinces and municipalities, various pieces of regulations and bylaws exist to combat substance abuse. Table 1 Relevant policies and legislation for substance use Relevant policies and Focus/objectives legislation The National Drug Master Plan Outlines programmes and policies of the government to address substance use problems in South Africa. The National Liquor Act, 2003 The primary focus is on regulation of the liquor industry. The Act seeks to facilitate the alcohol abuse and promote the development of a responsible and sustainable liquor industry; and provides for public participation in liquor licensing issues. Provincial Liquor Bills/Acts Provision of liquor licenses for retail sale of alcohol; establishment of Liquor Boards to; establishment of liquor officers and inspectors; and to provide for appointment of municipalities as agents of the Liquor Board and liquor licensing authorities. Education Laws amendment Act, Provides for random search, seizure, and drug testing at schools. Drugs and Drug Trafficking Act, Prohibition of use of drugs and possession, dealing/supply, manufacture, search and seizure 1992) Minimum Norms and Standards for Specifies acceptable quality of care for people, including children, receiving in-patient and outpatient treatment; 6 In-Patient and Out-Patient regulation of treatment centres to ensure services are delivered in accordance with human rights culture and legal Treatment Centres (National and constitutional frameworks; include special provisions for protection of children. It is an advisory body established in terms of the Prevention of and Treatment for Substance Abuse Act (Act No. Development Communication Conducts mass media campaigns, and social mobilisation and advocacy activities. Soul Buddyz is a special project for children focusing on issues related to substance abuse including relationships, sexuality, bullying, abuse, corporal punishment, disability, road safety and other accidents, like burns and drowning. For every 100 people, 15 have a drug problem and for every 100 Rands in circulation, 25 Rands are linked to the substance abuse problem (Christian Addiction Support, 2016). Jointly, the three drugs accounted for over 86% of all cases treated for drug abuse in 2012. Among persons treated for addiction, 38% were treated for cannabis dependency, followed by methamphetamines at 23%, heroin at 19% and cocaine at almost 6%. A similar trend was noted in a study of five trauma units in Cape Town, Durban and Port Elizabeth. It was found that 14% of the patients tested positive for white pipe (combination of cannabis and metaxalone), 33% for cannabis; and 15% for metaxalone. Although the youthful population of South Africa, which numbers 13 million (15-24 age 8 cohort), creates a window of opportunity, the creativity, innovation, talents and energies of this population will remain fully unharnessed due to substance abuse. Figure 3 maps the trends in substance abuse from the Youth Risk Behaviour Surveys (2002, 2008 and 2011. Although showing a somewhat declining trend, over the counter and prescription are the most abused substances among both males and females outside of dagga. Among males, heroines shows an increase while mandrax, cocaine and tik are on a decline. For females, there seems to be a decline in the incidence of life time substance use outside of dagga. Figure 5 shows a stable, but high cannabis use among youth, with substantial gender disparities. About 50% of the learners had taken alcohol, 30% had smoked cigarettes, 13% had cannabis in their life time, and 7. Substance abuse among learners has gendered dimensions as well, with male learners outdoing their female counterparts in every type of substance abused. In South Africa, cannabis (Dagga) is the third most abused substance by youth after alcohol and tobacco (Morojele et al 2013). Figure 6 to 8 takes a closer look at cannabis use from a survey of Grade 8-10 Western Cape learners (ibid). The picture painted by Figure 9 shows the following, among others,  The prevalence of drug abuse is highest among male learners than female ones  Female learners are more likely to abuse mandrax, methamphetamine and cocaine 13 Figure 9.

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Further purchase 2 mg artane visa homeopathic treatment for shingles pain, the risk of haemorrhagic stroke affected only people with a very low cholesterol concentration and buy generic artane on-line tennova comprehensive pain treatment center north, even in this group effective artane 2mg advanced pain treatment center, the risk was outweighed by the benefits from the reduced risk of coronary heart disease purchase artane online from canada pain treatment options. In the Cholesterol Treatment Trialists Collaboration meta-analysis, there was no evidence of an effect on cancer deaths. The reduction in major vascular events was as marked in these elderly patients as in those aged under 65 years. However, there was an apparent excess of non-melanoma skin cancer in the simvastatin-treated group, compared with the placebo group (2. In the Scandinavian Simvastatin Survival Study (342), 21 patients in the statin group developed non-melanoma skin cancer, compared with seven in the placebo group. Overall, there is no statistically significant evidence that statin therapy increases the incidence of cancer. Treatment of those most at risk will bring the most benefit; treatment of patients not at high risk of cardiovascular disease may expose them to adverse effects without much benefit. As the side-effects of liver and muscle damage are dose- dependent (340), the high-dose statin regimens evaluated in some of the trials (344) will have a worse side-effects profile when applied to patients treated in everyday clinical practice. Fibrates reduced the risk of major coronary events by 25% and niacin by 27% (349). However, recent studies have not found a cholesterol level below which there is no benefit, suggesting that taking a trial-validated dose of a statin is more important than aiming for a particular target cholesterol level (321). Thus, continued moni- toring of blood lipids may not be necessary in settings with limited resources. Primary prevention trials (320, 322, 323) have demonstrated that patients at highest total risk of cardiovascular events obtain the greatest benefit from statin therapy. Treatment should therefore be targeted at the group with highest total risk, rather than simply those with highest lipid levels. Cost-effectiveness, feasibility and resource implications of antihypertensive and statin therapy The cost-effectiveness of a treatment is determined by the relationship between the benefits obtained and the expenditure. The prevalence of a condition and the total cost of treating it in a specific setting, on the other hand, determine affordability. Because resources are limited, even a cost-effective treatment may not be affordable. The two main determinants of cost-effectiveness are the cost of drug therapy and the initial cardiovascular risk of the patient. In the case of antihypertensive treatment, the major classes of antihypertensive drugs are largely equivalent in terms of efficacy. However, diuretics and beta-blockers, singly or in combination, are associated with an increased incidence of diabetes; thus, in populations with an increasing burden of diabetes, other classes of antihypertensive therapies may be preferable. In most parts of the world, a diuretic is the cheapest option and is, therefore, generally most cost-effective. However, for certain compelling indications, other classes will provide additional benefits; even if they are more expensive, they may be more cost-effective. There is no evidence to support claims of superior performance of any particular drug within each of the major drug classes. As popula- tions age, increasing numbers of elderly people are being diagnosed as hypertensive and requiring treatment. For this group, diuretic-based therapy is the most cost-effective; therapy that includes either atenolol or low-dose reserpine has been shown to be a relatively inexpensive approach to prevention of cardiovascular events in older adults with isolated systolic hypertension (351). Although people over the age of 75 years get less benefit from statin therapy, such therapy is cost-effective for people in all age groups with a 10-year cardiovascular risk of 20% or more (352, 353 ). Thus, if the decision is made to initiate statin therapy, the least expensive statin should usually be chosen. Control of glycaemia Issue Does control of glycaemia reduce cardiovascular risk in patients with diabetes? Evidence Cardiovascular disease accounts for about 60% of all mortality in people with diabetes. The risk of cardiovascular events is 2–3 times higher in people with type 1 or type 2 diabetes (354, 355) and the risk is disproportionately higher in women (354, 356). Patients with diabetes also have a poorer prognosis after cardiovascular events compared with non-diabetics (357, 358). Epidemiological evidence also suggests that the association between blood glucose and cardiovas- cular disease begins before diabetes manifests itself (357–361). In a meta-analysis of non-diabetic subjects, those with the highest blood glucose levels had a relative risk for cardiovascular disease events of 1. This suggests that cardiovas- cular risk increases as glucose tolerance becomes impaired and then progresses to diabetes (362). However, the difference in the number of events in the two groups was not significant. Each 1% increase in HbA1c level was associated with a 14% increase in the incidence of fatal or nonfatal myocardial infarction (368). However, intensive treatment of patients with newly diagnosed type 2 diabetes, with sulfonylureas or insulin, resulted in a 16% reduction (P = 0. There was no “threshold” of glycaemia at which there was a significant change in risk for any of the clinical outcomes examined. The rate of increase of microvascular disease with hyperglycaemia was greater than that of macro- vascular disease. Metformin is safe and effective for treatment of type 2 diabetes, either as monotherapy or in com- bination with other drugs. The role of the newer insulin secretagogues, the thiazolidinediones, is still being evaluated in clinical trials. In most circumstances, metformin is the drug of choice for initial therapy of obese patients with type 2 diabetes and mild to moderate hyperglycaemia (370). For each patient the risk of hypoglycaemia must be considered when determining the target HbA1c level, especially in people treated with insulin and those with type 1 diabetes. Health care practitioners should be aware that more intensive glycaemic control increases the risk of hypo- glycaemia. However, it is important to set targets appropriate to the individual and in consultation with him or her. It is also important to recognize that adherence to medicines is much lower in real-life settings than in clinical trials. The results of controlled trials are unlikely to be achieved in clinical practice unless specific measures are taken to improve compliance with treatment. In summary, good glycaemic control should be a key goal of treatment of diabetes, to delay the onset and progression of microvascular and macrovascular disease. Treatment should aim to achieve: ● a fasting blood glucose level of 4–7 mmol/l (72–126 mg/dl); ● an HbA1c level of 6. The first approach to controlling glycaemia should be through diet alone; if this is not sufficient, oral medication should be given, followed by insulin if necessary. Aspirin therapy Issue Does long-term treatment with aspirin reduce cardiovascular risk? The numbers of women enrolled in most of these trials were too small to allow robust con- clusions to be drawn about the role of aspirin in primary prevention for women.

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Facilities which plan to introduce new practices will need to produce more documentation than facilities which only replace a unit and usually require permits from other governmental entities such as the ministry of health order artane with american express treatment for dog pain in leg, which regulates medical practices best artane 2 mg swedish edmonds pain treatment center. In facilities of countries which do not have any radiation safety legislation purchase artane with visa pain management for dogs after spay, it is the responsibility of the facility manager to ensure that the equipment and its use comply with international safety standards discount artane pain diagnostic treatment center sacramento ca. The compliance should be documented in writing and be made available to the staff and to the patients and public, if required. Site preparation Good coordination should exist between equipment acquisition and site preparation. The room in which the equipment is to be housed needs to be ready before the equipment arrives, so that its installation can proceed smoothly. Clearing customs If the equipment comes from a foreign country, import permits are required. The facility manager must ensure that the documentation required in customs clearing processes is ready well before the equipment arrives. Installation Arrangements for installation, including the need for cranes and other heavy machinery, should be made in advance of radiological equipment arrival. Contractors and local staff must be properly protected and monitored if they can be exposed to ionizing radiation during their work, for example when a cobalt source is exchanged. Acceptance testing Acceptance testing is the process of determining whether the unit meets acquisition specifications. Acceptance tests are normally done between a person of the institution (preferably a medical physicist) and an engineer or technical representative of the manufacturer. For second hand equipment, compliance with the original manufacturer’s specifications can be tricky, unless it has been specified in the acquisition agreement. Previous service records should be examined in detail, and repaired or replaced components should be tested very carefully to assess whether they may compromise safety. Adjustment costs may have to be borne by the user, unless clearly indicated in the acquisition agreement that the responsibility is the institution’s or the company’s providing the equipment. Consumables, such as X ray film or printing paper, should be available at acceptance testing, to ensure that the tests can be performed and documented. Commissioning Commissioning is the process in which the necessary clinical data are acquired so that the unit can be used clinically. If so, these data should be consulted and verified before allowing patient examinations or treatments. Verification should be performed by a knowledgeable and competent medical physicist and should be more or less extensive depending on the complexity of the equipment. Establishment of quality control/quality assurance programmes Based on the acceptance testing and on the acquired data during commissioning, it is important to develop a set of tests and establish compliance criteria to check that the unit continues to perform adequately. The institution’s medical physicist should assume responsibility that the unit always functions within the established tolerances. Specific attention was given to: (i) the situation in developing countries, where access to proper imaging must be improved; (ii) the fact that training in diagnostic imaging and radiation protection is part of the safety culture; and (iii) the need to normalize education requirements for radiation, which is a high priority. The areas covered were the need for dose reduction as a result of standardized quality assurance procedures, education and training, and the development and implementation of a sustainable safety culture, research needs to improve the knowledge in individual radiosensitivity of patients, as well as the access to proper imaging techniques and training in diagnostic imaging and radiation protection in developing countries. Integration of radiation protection and safety It is important to include radiation protection and safety plans in management control systems in hospitals. This can best be achieved by involvement of key managers, authority given to radiation protection experts and transparent internal audits. Key challenges within such a process include effective communication within the organization and adoption of a graded approach towards radiation and safety. Dose assessment and national registries It is important to assess effective collective doses from diagnostic X ray and nuclear medicine examinations. This can be best achieved by establishing national registration systems to monitor frequency and doses, with the aim of identifying long term trends. The results can be used to select priorities for clinical audit and optimization actions. Experience shows that it is beneficial to engage stakeholders (professionals, institutional representatives, users) in developing methodology for clinical audits focusing on processes and outcomes. Of equal importance is the cooperation between authorities and professionals when establishing clinical audits. Quality assurance, education and training, and the development of a radiation safety culture Radiation protection is embedded in everyday clinical practice and is part of overall standard procedures. Radiographers have an important role in medical radiation protection; it is important that their education and training meets high standards. There is a strong need for increased cooperation between education and training organizations and employers. Adherence to dose reduction should be rewarded through accreditation and communication. Education to achieve a culture of radiation protection should go hand in hand with promoting justified use of radiation based examination. Risk management measures reduce the potential or even prevent unintended exposures and they are, therefore, a critical component of radiation protection culture. There is a need to demonstrate, through standard health technology assessment, that radiation protection measures, such as technological development, meet clinical cost– benefit requirements. The establishment of a safety culture is a focus area within the efforts of the International Radiation Protection Association to develop and enhance a strong radiation protection culture. The implementation of the Basic Safety Standards in health care at the global level Access to high quality and safe radiotherapy is particularly essential for developing countries. Specific attention should be given to developing countries, where access to proper imaging should be improved and training in diagnostic imaging and radiation protection should be a high priority. Individual sensitivity One of the key future impacts on medical radiation protection from advances in radiobiology is the specific consideration of the individual sensitivity of patients to ionizing radiation. There is an increasing opportunity to take into account the variability of the individual sensitivity of patients in diagnostic applications of ionizing radiation. Specific emphasis is on the most sensitive patients, the most sensitive tissues, the examinations with the highest dose and the most frequent examinations. Repeated medical exposures of young patients that are hypersensitive to ionizing radiation are a major concern for radiation protection. If fully established, the system of radiation protection may need to be revised to take into account individual sensitivity to ionizing radiation. In order to improve our knowledge of this important question, individual sensitivity and hypersensitivity to low doses of medical imaging and consequences for radiation protection systems and practices have to be explored further by targeted research activities. Moreover, the technical development in diagnosis and therapy has increased the capabilities for more targeted and individual approaches. Radiation protection and safety issues are closely linked to patient safety issues, and management control systems must include radiation protection and safety. Consideration should be give to make maximum dose reduction techniques mandatory in new acquisition techniques. It is recommended to replicate the best practices that have been applied to the nuclear industry and adjust them to the medical sector. As the ultimate goal is to arrive at a situation where medical radiation protection is evidence based, there is a need to narrow the gap between evidence and practice.

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Fetal complications include macrosomia, the anti thyroid agent of choice before and during shoulder dystocia, malformations, intrauterine death, the first trimester (as methimazole is associated cardiomyopathy, polycythemia, hypoglycemia, hypo with fetal abnormalities during this period), while calcemia and hyperbilirubinemia methimazole should be used for the remainder of http://www. For significant hyperthyr also increased metabolic demand during pregnancy oidism symptom, give b blocker. Eclampsia, intracerebral bleed, and lepsy, 25% will have " frequency, 25% will have # cerebral vein thrombosis may lead to seizures in frequency,and50%willnotchangeinpregnancy. Cesarean be prescribed to all women on antiepileptics in the delivery safe if platelet >50Â109/L; 5% of newborns childbearing age. If adjuvant radiation indicated, bosis, or 3 unexplained consecutive T1 losses, or 1 or it should bedeferred until after delivery. Anthracycline more unexplained morphologically normal T2 loss, or containing adjuvant chemotherapy can usually be <34 week preeclampsia/eclampsia/placental insuffi safely given during 2nd and 3rd trimesters, but not in st ciency; plus laboratory criteria of elevated anticardioli 1 trimester or within 2 weeks of delivery. Hormonal therapy requiresatleast one clinicaland one laboratory criteria is contraindicated during pregnancy. Cigarette smoking is a greater risk tine such as relief of anxiety and arousal; (2) the factor than pipe and cigar smoking. Smokers have a pleasurable effects of associated environmental 10 30Â increased risk of developing lung cancer. Amyloid stains red mulation in neurovisceral organs (acute porphyrias) with Congo red dye and shows ‘‘apple green’’ bire and/or skin (cutaneous porphyrias), with specific fringence under polarized light symptoms related to the nature of precursors. Chronic nal Ig, may be essential or due to connective photosensitive skin symptoms include excessive tissue diseases)! Ideally cularis, purpura), hyperviscosity/thrombosis (Ray collect samples during acute attack. Balloon 3 severe disease process which limits activity but angioplasty=proceed to step 2; bare metal is not incapacitating (1. Greater than 14 days between balloon angio 5 moribund patient not expected to survive 24 h plasty and planned surgery? Yes=proceed to with or without an operation (34% mortality) the operation room with aspirin; no=delay for E suffix for emergency surgery for any class elective or non urgent surgery 3. Pain induced myocardial ischemia on preoperative control(consider epidural analgesia orintercos stress testing, and left ventricular systolic dys tal nerve blocks) function). Calciumchannelblockers (continueupto Â3 days if high risk and patient unable to com and including day of surgery. Oral hypoglyce 7 10 days before surgery and restart 6 h mics (continue up to day before surgery and postop). If used following procedures, may give 1/3 to 1/2 long or inter angioplasty, continue for at least 6 weeks before mediate actinginsulindose. The (legally may exercise therapeutic privilege, but sel selection of guardian is based on patient’s wishes, dom used) values and beliefs more than his/her best interest judgment. It is unfair to begin rationing by denying resources (causation) to the most vulnerable patients 5. Financial considerations court/law, patient consent obtained, or if public inter should be taken into account, but do not justify est at stake (e. Frequent pulse check, intubaton, central line inserton, and medicatons may sometimes distract the team from this important task Airway—avoid hyperventilaton as this could increase ntrathoracic pressure. The normal values for individual institu Manual of Style: A Guide for Authors and Editors. Commissioning Strategy Finance Publications Gateway Reference: 03923 Document Purpose Implementation Support Document Name What is a biosimilar medicine? Cross Reference N/A Superseded Docs N/A (if applicable) Action Required The guide is a factual resource which can be used locally to inform finance and procurement discussions in regards to biosimilar medicines. Whilst this document may be printed, the electronic version posted on the intranet is the controlled copy. As a controlled document, this document should not be saved onto local or network drives but should always be accessed from the intranet. Throughout the development of the policies and processes cited in this document, we have:  Given due regard to the need to eliminated discrimination, harassment and victimisation, to advance equality of opportunity, and to foster good relations between people who share a relevant protected characteristic (as cited under the Equality Act 2010) and those who do not share it; and  Given regard to the need to reduce inequalities between patients in access to and outcomes from healthcare services and to ensure services are provided in an integrated way where this might reduce health inequalities. Key messages:  Biological medicines are medicines that are made or derived from a biological source and as such are complex, with inherent variability in their structure. It is a biological medicine which has been shown not to have any clinically meaningful differences from the originator biological medicine in terms of quality, safety and efficacy. However, they will have met regulatory requirements in terms of comparative quality, safety and efficacy. Key terms are highlighted in grey throughout the document and are explained in more detail in the glossary. European Medicines Agency, has authorised biosimilar medicines for infliximab (the first biosimilar monoclonal antibody), insulin glargine and follitropin alfa, to add to those already approved; somatropin, filgrastim and epoetin alfa. Further biosimilar medicines are in development or under review for approval as originator biological medicines come off patent. Biological medicines are derived from living cells or organisms and consist of large, highly complex molecular entities which may be difficult to characterise. Due to the variability of the biological system and the manufacturing process, biological medicines may show a certain degree of variation, even between batches of the 1 same product. A biosimilar medicine is a biological medicine that is developed to be highly similar 2 and clinically equivalent to an existing biological medicine. A biosimilar contains a version of an active substance of an already approved biological medicine, which is referred to as the ‘reference medicine’ or ‘originator medicine’. Biosimilar medicines are not the same as generic medicines, which contain simpler chemical structures and are identical, in 4 terms of molecular structure, to their reference drugs. Biosimilar medicines require distinct regulatory pathways from those applied to generic medicines as they are not exact replicates of the originator (reference) medicine. The shortened and simplified regulatory approval process used for generic 7 medicines is not sufficient to demonstrate similarity. The main part of the evaluation is a detailed head-to-head comparison of the biosimilar medicine with its reference medicine to show that there are no clinically significant differences 12 between them. The biosimilar pathway does not seek to demonstrate safety and efficacy for each indication of the biosimilar medicine, as this is done by reference to 13 the originator product, which has already satisfied these requirements. All biologics may exhibit batch to batch variability which is controlled and maintained A: Biological medicines change in within defined and approved limits.

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