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By D. Tragak. Saint Edwards University. 2019.

The most relevant of these involve the respi- Oxygen consumption and carbon dioxide production are ratory and cardiovascular systems buy ashwagandha 60caps on line anxiety symptoms vs pregnancy symptoms. Supine positioning exacerbates these a median survival 8–10 years less than those with normal body problems resulting in further hypoxia 60 caps ashwagandha anxiety 37 weeks. The incidence of obstructive sleep apnoea (apnoeic episodes Obesity is associated with a number of cardiovascular comorbidi- secondary to pharynhgeal collapse during sleep) and obesity ties including hypertension discount ashwagandha 60caps with visa anxiety symptoms like heart attack, ischaemic heart disease purchase ashwagandha 60 caps free shipping anxiety symptoms 4 days, arrhythmias, cardiomyopathies and cardiac failure. Symptoms may therefore only manifest when the patient experiences a traumatic event or physiological stress. Other relevant conditions associated with obesity include dia- betes (40× increased risk compared with non-obese population) and gastro oesophageal reflux disease. If bag valve ventilation for other indicators of a difficult airway (see Chapters 6 and 9). If the circumstances Careful attention should be paid to airway pressures and tidal allow, timely transfer of the patient to a facility with experienced volumes. Ifadvancedairwaymanagementisnecessary,meticulous preparation and patient positioning should minimize unsuccessful Spinal immobilization attempts. Prolonged pre-oxygenation should be performed using Care should be taken when choosing the appropriate size of neck high flow oxygen with a tight fitting mask. Correct patient position- collar the largest size available may not fit the largest of patients. Not all patients will safely fit ideal position is having the sternum level with the tragus of the ear onto a standard spinal board; an adjustable scoop stretcher should (Figure 31. Specially designed bariatric rescue stretchers are available for immobilization and patient movement and should be used Tragus level where available. Excellent clinical acumen and a high index of suspicion are therefore nec- essary. Specialized equipment is available including stethoscopes with increased sound amplification and ambient noise reduction as well as Doppler stethoscopes. Measurement of peripheral oxygen saturations may not always be accurate due to excess adipose tissue: probes should ideally be placed on an ear lobe. An appropriate size blood pressure cuff should be Vecuronium used; a cuff too small may lead to falsely elevated blood pressures. Equipment, transport and manual handling Vascular access can be challenging in this patient population. Equipment to care for and safely transfer the morbidly obese patient Intraosseous access should be considered early if attempts to gain is both essential and expensive; prehospital providers may need to peripheral access fail. If available and time limits will depend on a number of factors including the type of allows, the use of ultrasound-guided intravenous catheters may be aircraft,spacewithinaircraft,weightofthecrew,weatherconditions beneficial. Specially adapted ground ambulances should be available and should contain all the necessary bariatric equipment. This will include expandable, double width stretchers capable of Disability and exposure carrying 318 kg (50 stone), compared to the 191 kg (30 stone) limit Exposure of all areas may be difficult due to the patients weight; of standard stretchers (Table 31. Wounds may to 476 kg (75 stone), hoists, winches and inflatable lifting cushions be concealed by skin folds, so vigilance is essential. Correct manual handling techniques are essential when dealing Drugs with morbidly obese patients. Back injuries are the number one The pharmacokinetics of many drugs are affected by the mass of injury for all prehospital staff. All staff should receive adequate adipose tissue resulting in a potentially less predictable response. The Broca formula can be used Product Limits Other information to estimate the ideal body weight (Table 31. Whenever possible Ferno Model 65 Scoop Load limit: 350lbs doses should be carefully titrated to response. Stretcher (159kg) Suxamethonium dosing should always be calculated using total Stryker Power-pro Powered Weight capacity: Battery powered body weight and given at a dose of 1 mg/kg (up to 2 mg/kg in Ambulance Cot 700lbs (318kg) hydraulic lift system children) to optimize intubating conditions during rapid sequence Equipment Hook – Model 6500-147-000 induction. D) (227kg) Communications Communicating between the prehospital providers and the receiv- ing facility is essential to provide the safest care for the morbidly obese patient. This can allow the receiving hospital to prepare suitable trolleys, equipment and manpower. Every prehospital service should have specific protocols for the care of morbidly obese patients to ensure that they receive the same standard of care as the rest of the population. This should include the purchase of specialized equipment as well as adequate training of their personnel. These are complex patients and require a multidisciplinary approach • Always assume multiple comorbidities, particularly those affecting the cardiovascular and respiratory systems • Although tracheal intubation is not necessarily more difficult than in non obese patients, rescue techniques (such as bag valve mask ventilation) are, and patients can rapidly desaturate and decompensate. Fully optimize conditions for your first intubation attempt • Correct patient positioning is of paramount importance, as are correct manual handling techniques to achieve this positioning! Further reading numbers of trained staff are present; in the prehospital environment this can often include members of the fire service. Emergency department management of the airway in Extrication from the scene of an accident or even from the obese adults. To be most effective there should be seamless transition between care in the prehospital, transport and hospital environments. The usual operating paradigm in patient transport has been to ‘bring the patient to care’ and enable access to higher levels of care large centres usually for subspecialty services are sometimes called or definitive management. Highly trained retrieval teams Primary retrievals may be further categorized as ‘land on’ or can optimize patient outcomes by earlier introduction of critical ‘winch’, depending on whether site access is possible. The characteristics of primary and secondary retrievals are at least equal care at the referral point and also prepare the patient described in Table 32. The risk of transport should (transport frame, equipment, staff ), and helps define retrieval not exceed any potential benefit the patient may obtain from the services roles. Some are purely pre- hospital, some offer neonatal services, while others are mixed (all Definitions and terminology ages, ‘medical’ and trauma). Distances may range from inner-city responses, to decentralized rural populations where long fixed-wing Patient retrieval can be defined as the use of clinicians (medical, flight times may be needed (Figure 32. Casemix and geogra- nursing, paramedic, other) to facilitate clinical management and phy are integral in determining the structure of retrieval services safe transport of a patient(s) from one location to another. Secondary Crewmix retrievals are from one health facility to another and are also referred to as interfacility transfers. Patient movement between Physicians, paramedics, nurses and other personnel are all used as transport and retrieval crew. System variances are determined mainly by historical difference in prehospital care models. Regardless of discipline, crew should be adequately trained and Edited by Tim Nutbeam and Matthew Boylan. Computer-assisted dispatch systems offer consistency and data integrity while clinician-based systems offer clinical acumen and local knowledge. While the outcomes of tasking decisions may be different for an injuredswimmerandasickchildonaremoteproperty(Figures32. While safety and patient outcomes are the primary considerations these are not mutually exclusive. Tasking and coordination Effects of transport Tasking and coordination of patient retrieval is summarized by the adage ‘getting the right patient to the right place in the right Patient transport is not without risk even in perfect weather. The transport environment has its own unique characteristics that Increasingly in health care we need to add ‘at the right cost’.

Other associated conditions producing seizures or strokes or inhalants include increased risk of cancer of the liver generic 60 caps ashwagandha otc anxiety zoning out, producing cardiac arrhythmias that can lead to 149 breast cheap ashwagandha 60caps online anxiety ocd, mouth buy ashwagandha 60caps mastercard anxiety care plan, throat order ashwagandha 60caps fast delivery social anxiety symptoms yahoo, esophagus and colon, sudden cardiac deaths), but also the infections and recent research suggests that risky alcohol transmitted via drug self-administration (e. Heavy alcohol use during pregnancy is Marijuana use is associated with sexually associated with miscarriage and stillbirth and is transmitted disease due to unsafe sexual one of the primary causes of severe mental and behaviors engaged in while under the influence 151 developmental delays in infants. Marijuana use is associated with the 154 onset of psychotic disorders, particularly in in combination with alcohol (2,792 deaths). Methamphetamine, cocaine and other stimulant Enough prescription painkillers were prescribed use (including the use of amphetamine-related in 2010 to medicate every American adult 174 and other “designer drugs”) are associated with around-the-clock for a month. The risky use of controlled prescription drugs was involved in Approximately 160,000 pregnancies in 2004 166 an estimated 1,079,683 emergency department were associated with illicit drug use. Marijuana and cocaine exposure The risky use of prescription opioids can result have been linked to impaired attention, language in a range of consequences from drowsiness and and learning skills, as well as to behavioral 169 constipation to depressed breathing, at high problems. Even a large single dose of opioids can 177 lead to severe respiratory depression or death. Infants exposed to prenatal illicit drug use are at 170 One study found that individuals with addiction increased risk of low birth weight, involving opioids had significantly higher rates developmental and educational problems and 171 of comorbid health conditions, including future substance use and addiction. Controlled Prescription Drugs ‡ At high doses, risky use of prescription In 2008, there were an estimated 20,044 § stimulants can produce anxiety, paranoia, overdose deaths attributable to risky use of 179 seizures and serious cardiovascular controlled prescription drugs. Overdose deaths from controlled §§ interactions with other drugs and sudden prescription drugs have increased significantly 181 death. Likewise, risky use of barbiturates, such as butalbital and phenobarbital, can lead to changes in alertness, 183 irritability and memory loss. If combined with certain medications or alcohol, tranquilizers and sedatives can slow both heart rate and 184 respiration, which can be fatal. Taking certain controlled prescription drugs during pregnancy, such as alprazolam (Xanax) or phenobarbital, may harm the developing 185 fetus. Few of these individuals, however, are routinely screened for risky use of addictive substances or receive any services designed to reduce such use such as 2 brief interventions. Of those who do receive some form of screening, in most cases it involves only one type of substance use-- tobacco or alcohol--which fails to identify risky use of other substances or recognize that 30. In order to reduce risky use and its far-reaching health and social consequences, which may include the development of addiction, health 4 care practitioners must: *  Understand the risk factors, how these risks vary across the lifespan and how risky use-- whether or not it progresses to addiction-- can have devastating outcomes for individuals, families and communities;  Educate patients, and their families if relevant, about these risks and the adverse consequences of risky use;  Screen for risky use of addictive substances and related problems using tools that have been proven to be effective; and  Provide brief intervention when appropriate. To assure that † oppositional defiant disorder and conduct these health care services are provided, a range ‡ 10 § 11 disorder, those who engage in bullying of barriers must be addressed, including ** 12 and those who have sleep problems; and insufficient training of health care and other professionals and a lack of trained specialty  Children who are maltreated, abused or have providers to which patients with addiction can 13 suffered other trauma. Hormonal changes that occur adolescence with the initiation of risky use of 6 during adolescence also pose a biological risk addictive substances, but the onset of risky use for substance use in this age group. The surge in and addiction can occur at any point in the the female hormone estrogen and the male lifespan. Common * 7 behavioral symptoms include defiance, spitefulness, of substance use and its consequences, but signs of risk sometimes can be observed much negativity, hostility and verbal aggression. In addition to the overall risks enormous difficulty following rules and behaving in a associated with substance use, children and socially-acceptable manner. These children may adolescents with heightened risk of engaging in bully others, start fights, show aggression toward substance use, of experiencing the adverse animals, steal or engage in sexually inappropriate consequences of risky use and of developing behavior. The lack of fully developed decision-  Coping with the stresses of child rearing, making and impulse-control skills combined balancing a career with family and 23 with the hormonal changes of puberty managing a household; compromise an adolescent’s ability to assess risks and make them uniquely vulnerable to  Facing divorce, caring for an adult family 16 substance use. In recent years, researchers have begun to recognize the developmental stage of young Middle aged and older adults who engage in adulthood--often referred to as emerging risky use may be even more vulnerable to the adulthood--as a period of life that is strongly health consequences of such use since physical 18 associated with risky use. Young adults facing tolerance for alcohol and other drugs declines heightened risk include: with age: the ways in which addictive substances are absorbed, distributed, *  College students-- --while approximately metabolized and eliminated in the body change two-thirds of college students who engage in 27 as people get older. With regard to alcohol, substance use began to smoke, drink or use several biological factors account for reduced other drugs in high school or earlier, the tolerance. The amount of lean body mass culture on many college campuses permits (muscle and bone) and water in older adults’ and promotes risky use rather than curtailing bodies decreases as the amount of fat increases, 19 it. Reduced liver and kidney function slows down the  Young adults facing work-related stress or metabolism and the elimination of alcohol from instability in living arrangements, social the body, including the brain. Young adults may turn to addictive substances to The increasing susceptibility to substance- relieve these forms of stress and self- induced neurotoxicity with age is a growing medicate their anxiety and emotional concern as the “Boomer” generation, a 21 29 troubles. The interaction of prescribed and other drugs Middle and Later Adulthood with alcohol also is of great concern for the physical and mental health of middle and older Major life events and transitions increase the adults who are likelier than younger people to chances that an individual will engage in risky use prescription and over-the-counter 22 30 use of addictive substances. Therefore, any signs and symptoms of risk and seeking attempt to identify risky use of addictive professional help at the first sign of trouble. Being informed of a Screening, a staple of public health practice that 34 patient’s health conditions that might be caused dates back to the 1930s, serves to identify early or exacerbated by substance use or that might signs of risk for or evidence of a disease or other cause or exacerbate the patient’s addiction will health condition and distinguish between help medical professionals determine individuals who require minimal intervention appropriate interventions and provide effective and those who may need more extended 32 35 care. It is an effective method of patients with medical conditions that frequently preventive care in many medical specialties, and co-occur with risky use and addiction--such as risky use of addictive substances is no hypertension, gastritis and injuries--should be exception. Screening for risky use of addictive prompted to screen for risky use of addictive substances is comparable to offering regularly substances that may cause or aggravate these scheduled pap smears or colonoscopies to 36 conditions. Patient Education and Motivation Educating patients and motivating them to reduce their risky use of addictive substances is 33 a critical component of preventive care. As part of routine medical practice, medical and other health professionals should educate their patients (and parents of young patients) about:  The adverse consequences of risky use and the nature of addiction--that it is a disease that can be prevented and treated † Despite the distinction between screening and effectively; assessment tools, the term screening often is used to subsume the concept of assessment or  The risk factors for substance use, tailoring interchangeably with the term in the clinical and the information to the patient’s age, gender, research literatures. Nevertheless, Chapter V mental health history and other relevant addresses assessments specifically. Depending on the Prevention and Control patient’s age, positive responses to these Centers for Disease Control and Prevention items would be followed by more in-depth questions assessing the level of the patient’s Screening tools typically are brief and easy to risk and the provision of appropriate brief 40 administer and are to be implemented with a interventions. Screening tools typically screening test to identify other drug use in a include written or oral questionnaires and, less diverse sample of adult primary care patients frequently, clinical and laboratory tests. However, most instruments focus on specific In recent years, attempts have been made to substances rather than the range of addictive develop and validate more simple screening substances that pose a risk for addiction. The instrument use has been validated on adult populations 37 actually contains four separate screens and asks for use in research protocols but also can be used clinically to determine if a patient is patients about the frequency of their past-year a current smoker. At Response options for each, on a five-point scale, the same time, looking for biological markers is range from never to daily or almost daily. Used more objective than using a patient’s self- 51 online, the screening tool tallies the responses to reports, as it is not subject to patients’ or generate a score indicating the patient’s level of examiners’ biases. It also Unlike tests for other diseases such as diabetes provides additional resources to help and hypertension which can be diagnosed using 43 practitioners intervene appropriately. It would help reduce billions of ‡ exceptions, laboratory tests for nicotine, alcohol dollars annually in lost productivity, injury and and other drugs generally inform health care social costs associated with risky behaviors. It § providers of whether patients recently have would also encourage those with chronic been using these substances rather than being conditions to get the treatment they need. The question is, when will society Individuals, groups and organizations may be 44 hesitant to agree to laboratory tests for substance demand this change? The who have not been exposed to environmental tobacco size of red blood cells also increases with smoke or a smoker who has not used tobacco or 49 prolonged heavy alcohol use. According to clinical guidelines, practitioners should provide Brief Interventions and Treatment brief interventions based on the “Five A’s”: Referrals  Ask. The process begins with inquiries about tobacco use, which should be made For those who screen positive for risky use of during every visit. Individuals who smoke should be interventions is an effective, low-cost approach 59 advised in a clear, strong and personalized to reducing risky use. Brief interventions generally include feedback about the extent and effects of patients’  Assess. Practitioners should determine substance use and recommendations for how whether or not a patient is willing to attempt 60 to quit.

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When the body (especially 10 lower body) is subjected to hypothermia or ischemia purchase ashwagandha 60caps otc anxiety disorder 3000, it responds by reduc- 11 ing the blood flow to the mucous membranes in the upper respiratory pas- 12 sages buy generic ashwagandha 60caps on line anxiety symptoms or ms. This and the drying of the mucous membranes due to excessive room 13 heating promote the growth of pathogens 60caps ashwagandha free shipping anxiety symptoms for 2 weeks. Nasal douches buy 60caps ashwagandha with mastercard anxiety jewelry, throat wraps, inhalation, sweat-inducing agents 18 (diaphoretics), and baths with aromatic herbs have proved to be effective. Activated macro- 49 phages secrete interleukin-1, interleukin-6, and tumor necrosis factor-α, 50 5. These mechanisms are activated when the pa- 3 thogen comes in contact with the oral mucous membranes. In those who already have a cold, 11 the course of the infection is less severe and the symptoms subside more 12 quickly. Since many antibiotics can suppress the immune system, these 13 herbal remedies should be helpful in patients with bacterial infections. Their effectiveness is not proven with clinical trials; they 8 fall more into the realm of pleasant-tasting home remedies. It can prevent the outbreak of a cold 18 if treatment by footbath is started early enough. When used for footbaths, add enough warm water 24 to cover the feet and ankles (see p. Prolonged exposure can cause skin irritation 27 and blistering, especially in patients with sensitive skin. The efficacy of 2 the herbal remedy is questionable when treatment is started at the climax 3 of the disease. Products 9 manufactured from the fresh, or recently-dried plants are preferred by most 10 herbalists. Oral administration of alcoholic ex- 13 tracts and homeopathic tinctures (mother tinctures to D2 tinctures) is report- 14 ed to be more effective than other preparations. The current data suggest that 15 preparations combining echinacea with other herbs are more effective than 16 echinacea alone. Supposed risks must be carefully 21 weighed against the expected but unproven benefits of treatment. In the early phases 26 of manifest disease, administer for a period of no less than 6 days and no 27 more than 14 days. The bronchial passages become ob- 7 structed owing to the thick mucous secretions and inflammation. The viscosity of the mucus starts to decrease over the 13 course of time (2 to 3 weeks). The damaged 21 membranes provide a foundation for further complications, such as pul- 22 monary emphysema, bronchiectasis, and bronchopneumonia. The bronchial glands are swol- 28 len, and large quantities of neutrophil granulocytes and macrophages 29 are present, even in the alveolar fluid. In mild cases, the patient should 32 drink large quantities of tea made from herbs selected according to the type 33 of cough. Expecto- 35 rants, preferably those with antispasmodic or immunostimulatory effects, 36 can be prescribed later if necessary. Eating large amounts of 27 eucalyptus candy can induce nausea and vomiting in children. Horseradish root can 21 cause isolated allergic side effects; higher doses of the herbal remedy can 22 cause gastrointestinal upsets. These pro- 17 ducts are safe to use, even by patients on concomitant antibiotic treatment. The stimulus is usually mechanical, but sometimes 7 also chemical or thermal in nature. The cough reflex travels through the af- 8 ferent nerve fibers to the cough center of the medulla oblongata. Con- 11 nected to the cough center are receptors in the auditory canal, esophagus, 12 and stomach. The secreto- 31 lytic and expectorant actions of certain essential oils develops more effec- 32 tively when the preparations are inhaled or taken in extract form. Saponin- 33 containing herbs, on the other hand, should be administered by mouth 34 since they work by stimulating the sensitive fibers of the gastric mucosa. Iceland moss contains 4 bitter principles that additionally stimulate the production of saliva and 5 digestive juices, thereby triggering a swallowing reflex that decreases the 6 cough reflex. Herbal remedies with primarily antitussive and anti-inflamma- 26 tory effects should be used. When allowed to dissolve in the mouth, 29 they not only have a pleasant taste but also stimulate the swallowing reflex, 30 which can be further enhanced by adding sugar or other sweeteners. Eosinophil granulocytes and other cells are typically found in in- 5 flamed bronchial tissues and bronchoalveolar fluids. Depending on which secondary herbal substan- 8 ces they contain, they can also relieve pain and speed up the healing process. They can be used alone or for adjunctive 12 treatment parallel to established synthetic drugs. Rinse mouth or gargle with 1 tablespoon infusion 16 in a cup of warm milk, 3 to 10 times a day as needed. When selecting the remedy, the individual preferences of the pa- 18 tients should be taken into consideration. The above conditions are characterized by permanent atrophy of 37 most mucous glands. Prepare an infusion using one or 23 more (equal parts) of these herbal remedies, or use the following tincture. It has a specific control 4 mechanism that is mainly localized in the hypothalamus and an unspecific 5 control mechanism in the limbic system. The pa- 11 tients generally become accustomed to the prescribed herbs or herb prepara- 12 tions within a few weeks, so the herbal remedies soon lose their initial efficacy. Once they reach the stom- 47 ach, they stimulate the release of gastrin, thus enhancing upper gastro- 48 intestinal motility. Bitters also stimulate the secretion of bile, pancreatic 49 juices, and pepsinogen. Swallowing bitter preparations in 38 capsules is less effective than use of preparations where the bitter flavor is 39 tasted in the mouth. Large interindividual differences in the 1 efficacy of these remedies can be observed. Erosions extending into the deep layers of the stomach 13 wall can be found on the mucous membrane of the stomach and/or duode- 14 num. It is 19 difficult to distinguish nerve-related disorders from common upper ab- 20 dominal complaints following meals (dyspeptic syndrome). The stomach 21 and duodenum (nausea, belching, upper abdominal discomfort) as well as 22 the small and large intestine (flatulence, cramplike abdominal pain, di- 23 arrhea) can be involved. Aromatic herbs also have bacteriostatic effects 7 and increase the local blood circulation. Because of its general efficacy and virtual lack of side effects, it is 10 still commonly recommended for adjunctive treatment at the onset of 11 and during acute ulcer episodes. Standardized 24 licorice root extracts made with diluted ethanol and containing no less than 25 4. The prepara- 28 tion is nearly as effective as whole licorice, but with fewer side effects. The patient 40 using flaxseed should drink plenty of fluids, at least 150 ml after taking the 41 herb.

Usually buy generic ashwagandha 60caps on-line anxiety 6 weeks pregnant, only very large and profitable could be based purchase ashwagandha 60caps otc symptoms 9f anxiety, followed by a proposal for a simple companies buy ashwagandha 60 caps low price anxiety upon waking, wishingto perform a community classification based on combined economic and service order ashwagandha 60caps free shipping anxiety 4 year old boy, or havingreasons other than profit- medical value. Generic drugstatus (whether or not marketed, where there is usually more certainty about the whether the same dosage form, strength, exci- medical value. Virtually every pharma- may stimulate the discovery and development of ceutical company that develops an orphan new treatments for their diseases of interest. Note that many can be either profit-orientated in most cases, as they usually public or private institutions, as well as either indi- accept social responsibilities for the patients they viduals or larger groups. Legislatures National, provincial, and other levels of legislature Trade Associations are involved in orphan drugdevelopment, primar- ily through creating new legislation. These exclusivity, tax relief, grant awards, waiving of ap- are concerned with the image of the industry, as plication and user fees, or quid pro quo arrange- well as providingsocial benefits through publiciz- ments of other types. Regulatory Authorities Patients and Families These authorities are primarily motivated to im- The motivation of those with the disease or with prove and protect the public health of the commu- affected relatives is clearÐthey want better treat- nity they serve through approval of effective and ments that are affordable and will improve quality safe new drugs. The motivation of these people is also clearÐthey seek better treatments for their patients and are Patient Associations often willingto test new drugs in clinical trials. Occasion- Orphan drugs offer research opportunities for sci- ally, they may serve as umbrella organizations for entists and academic clinicians, together with larger numbers of rare diseases, in order to achieve career enhancement opportunities. In this busy world, The process of discovering new orphan drugs is physicians want new and important medical not different from that used to discover drugs for information and are less willingthan previ- more common diseases (Spilker 1994); earlier chap- ously to see sales representatives. Several companies that have merged in principle, also do not differ from those used to recent years initially considered divestingor develop drugs for more common diseases in terms droppingsome of the smaller products from of strategies created, methodologies used, and cri- the portfolio. If there are only 500 patients with a specific and that the sum of their value was much disease, it is probably impossible to have two ran- greater than the sum of their sales, particularly domized, well-controlled placebo trials. Reporters can easily write heartwarming proportion of all the patients for whom the drugis stories of patients with rare diseases who are likely to be prescribed. Large company might occasionally allow Note that companies seekingan orphan approval, its sales representatives to discuss both the orphan while hoping (or even encouraging) off-label use drugwhen makingcalls about non-orphans. Because the safety and quality standards of The most obvious benefit for a company is that the manufacturingare the same, creation of a number of clinical trials and the quantity of clinical special formulation for orphan use may create data required for marketingapproval will usually too many technical problems and costs. A to treat patients with a rare disease could in- further possible benefit in some drugdevelopment crease the exposure of the company to a major programs is that less toxicology data may be re- court suit in return for minimal revenues. Thus, the time to develop the chemistry in 1983, and signed into law by President Reagan and technical package of data for the regulatory duringthe first few days of 1984. A grant program that included medical fo- There is no limit to the number of disincentives and ods and medical devices, although medical obstacles that could be described for developing foods and medical devices could not obtain orphan drugs. Orphan drugdevelopment may not be required per annum criterion, and makingunprofitability an if the drugis already marketed for a more optional, rather than a compulsory, alternative. The main reason is that patents for 1991 amendment would have established a sales biological proteins are are very difficult to obtain; cap, after which an orphan drugwould lose its orphan drugprotection is valuable while inventors exclusivity. There example, a drugto treat a rare rheumatological are a number of principles that will help a company disorder that could also be useful in rheumatoid establish such a difference: arthritis would likely require much more data for approval than if the drugwere limited to treating 1. On the other cally shown that two structures differ and this hand, a toxic but effective medicine that could makes a biological or clinical difference, both only be used to treat severe cases of patients with will be given orphan drug designation. If a marketed dosage form is unsatisfactory for certain pa- With over 650 active designations and now about tients, then a new dosage form suitable for 275 orphan drugs approved for the market (and them may be eligible for orphan drug designa- even one medical device), plus numerous grants tion. Let us not forget that nothing in the Act such methods lead to a difference in safety or creates compulsion, and that voluntary participa- efficacy, this would qualify for orphan drug tion, as measured by applications for designation designation. Differences in excipients that have been approved under this legislation remains lead to a difference in clinical safety or efficacy a controversial topic; probably these are an evasion would qualify for orphan drugdesignation. By early 2002, this had led to 131 Euro- that the indication is not a true orphan and usually pean orphan drugdesignations, and three orphan denies the application for orphan designation. Value to a most pharmaceutical products has followed a pre- patient or employer might also be making sure that dictable path from discovery to preclinical and clin- the drug prescribed maintains quality of life or ical development, approval and marketing. To be successful, the pharma- the onset of increased competition, decision makers ceutical developer must address the needs of all these want to hold down healthcare costs while maintain- decision makers. It is never too product, successful drug development today must early to begin to think about how the value of a now also focus on measuring other outcomes of a product will be demonstrated. The intent of this chapter is to help pharmaceut- Decisions, both large and small, relating to ical developers and researchers understand how to healthcare are now made based on information document the value of pharmaceuticals through gathered from economic and humanistic outcome appropriate pharmacoeconomic development pro- evaluations. Outcome information can be used to Outcomes research is the study of the end-results of help make decisions regarding the inclusion or ex- medical interventionsÐdoes the healthcare inter- clusion of drugs on formularies. The field of outcomes impacts that medications have on specific patients research emerged from a growing concern about can help healthcare providers make better prescrib- which medical treatments work best and for ing decisions. Outcomes span a broad range of types of Decision makers, including prescribers, pro- intervention, from evaluating the effectiveness of a viders, payers and patients, all want to maximize particular medical or surgical procedure to measur- the clinical value received for the money spent. Each of these factors plays a role pharmacoeconomic skills may not be a very good in the outcomes of care or the ultimate health status health economist, and vice versa. Understanding how they interact pharmacoeconomist or health economist, first de- requires collaboration among a broad range of termine what they will do, then evaluate their skills health service researchers, such as physicians, and experiences to make sure that they will be able nurses, economists, sociologists, political scientists, to deliver what is needed for your specific drug operations researchers, biostatisticians, and epi- development program. The set of criteria is used to That technology is becoming increasingly sophisti- determine whether someone is better or worse off as cated and the cost of such technology is potentially a result of a particular action. Pharmacoeconomic tools consideration in weighing decisions, and for reim- are derived from a variety of sources, including the bursement in socialized healthcare systems (where fields of economics and outcomes research. Health economists and a pharmacoeco- to the movement to extend outcomes measured nomists differ (while the terms are sometimes used beyond the traditional clinical outcomes associated interchangeably), in having stronger backgrounds with pharmaceutical research. Clinical Symptoms, diagnosis Pharmacoeconomic information demands are Adverse events often not anticipated early enough in the clinical Drug interactions development program. Clearly trade-offs clude health-related quality of life, patient satisfac- between the side-effects and benefits of the medica- tion with interventions and patient preferences. Prescribers will antihypertensive medication targeted for chronic no longer consider just the clinical impact, but also use, then preparing a submission with a goal of the economic impact their decision will have on having the drug prescribed is an accomplishment. The payer take the drug on a regular basis, as well as to ensure and patients will need to consider the impact of that the patient understands the pros and cons of their decisions on the rest of the system. An astute pharmacoeconomic re- outcome data as early as possible in the product searcher incorporates a quality of life component development life cycle. This information will also into appropriate comparative studies, so that pa- be useful to investors who are making decisions tient-derived and patient-reported aspects of treat- regarding the ultimate potential for success or fail- ment are considered in addition to the management ure of a newly discovered therapeutic product. Yet, a drug that is targeted for typically considered to aid the end-user, they also chronic use should be considered as a prime target have great applicability at the drug development for pharmacoeconomic study. This is not an entirely altruistic concern for going to be cured, and the patients are expected the pharmaceutical company: if incorporated early to take a product for the rest of their lives, there into the development of a drug, a strategic advan- should be some message that can be provided to the tage due to a more complete package of outcomes patient that will support their use of the product in information is available at the time of product a compliant fashion for a number of years. An understanding of the cur- product will have been lost; one of the most fre- rent burden of the illness or condition, in terms of quently requested pieces of information by formu- its natural history, resource use, and quality of life lary committees and reimbursement agencies is, profile, can help a research team put the estimated `What is the impact on my budget? The challenges associ- mean that the drug should not be developed, but ated with successfully incorporating pharmacoeco- the expected return on the drug must be put in the nomic components into a clinical development appropriate context. Early research can also iden- program include making sure the right people are tify targets for comparative studies; a must under involved early enough, so that delays do not occur. If research is conducted in the Pharmacoeconomic components to clinical studies most severe patients with a particular condition, do not have to be rate-limiting, but will be so when but they constitute only 5% of the treatable popu- the project team fails to bring the pharmacoecono- lation, then the perspective of those patients needs mist into the project at an early stage, i. This will mist to understand the characteristics of the inves- help to demonstrate how they might respond to tigational drug and the targeted conditions, and as treatment and to determine what the impact of the trials program is laid out, pharmacoeconomic the condition is on their quality of life. These questions should be asked before Preclinical Clinical Marketing hiring a staff pharmacoeconomist or consultant and embarking on a value-added development pro- Pharmacoeconomics gram. After reviewing the The need to demonstrate value has been discussed literature (and other sources such as the Internet), long enough, so that there is an expectation that the pharmacoeconomist should then formulate new programs will include some pharmacoeco- how to integrate which economic and humanistic nomic parameters; in many cases there may need outcome measures into the full development plan. To gather the remaining desired data risk±benefit assessment of taking the time to answer the investigators needed to collect prospectively each question thoroughly vs.

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