Sunday, July 21, 2019
Issues in Reporting Adverse Drug Reactions (ADRs)
Issues in Reporting Adverse Drug Reactions (ADRs) India is becoming a hub in the field of clinical research and a center for drug discovery and development and this advancement has created an urgent need to strengthen the current drug safety measures. Pharmacovigilance has emerged as an important field of science related to activities regarding detection, assessment, understanding detection and prevention of adverse drug reactions (ADRs) and other drug related issues. The current pharmacovigilance system is not fully able to address these issues because of certain ââ¬Å"challengesâ⬠being posed to it. While major advancements of the discipline of pharmacovigilance have taken place in the West, not much has been achieved in India. Some of the important challenges to our existing pharmacovigilance activities are: under-reporting, lack of knowledge, proper training, education, attitude and motivation, confusion regarding terminology and definitions used in pharmacovigilance. Increasing use of biologics and herbal medicines in cur rent medicine practice further pose challenges to our pharmacovigilance systems. There is lack of information about the active principle, efficacy, adverse effect profile, quality assurance/quality control, informal selling interaction potential in case of herbal drugs. On the other hand, a complex production process, limited predictability of preclinical to clinical data, high potential for immunogenicity possibility of an underlying exaggerated pharmacology in case of biologics further grieve the situation. Also there is need to improve the spontaneous reporting and causality assessment scales with high quality data submission. KEY WORDS: Pharmacovigilance, India, ADRs, AEs, Challenges INTRODUCTION India is an emerging hub in the field of clinical research and a destination for drug discovery and development. Several new drug entities, new dosage forms, vaccines etc. are being introduced in the country challenging the monitoring of adverse drug reactions over a large population base. The monitoring of both known and unknown side effects of medicines is important even if the drug is in use for several years so that the safety profile of the drug can be ascertained. This has paved the way for pharmacovigilance. Pharmacovigilance may be defined as the pharmacological science relating to the detection, assessment, understanding and prevention of adverse drug reactions or any other possible drug related problems (1), particularly long term and short term side effects of medicines. While major advancements of the discipline of pharmacovigilance have taken place in the West, not much has been achieved in India. Although in India, pharmacovigilance has progressed from the situation as it was in past, but for different types of problems and limitations progress is yet not very rapid. (2) The current review focuses on a number of elusive issues which require attention addressal: Under-reporting: India specific causes possible solutions Under-reporting is a major limitation of spontaneous reporting systems for suspected adverse drug reactions (ADRs) in India. It is both a technical and a psychological issue. Under-reporting may lead to failure to recognize an unacceptable risk associated with a particular drug. Furthermore, differences in reporting between different drugs may lead to apparent differences in the toxicity which may be spurious. It can lead to delay in signal detection and underestimation of the magnitude of the problem. There is a long exhaustive list focusing on the causes of under-reporting: Lack of awareness There is a general lack of awareness among health care professionals in terms of increasing health burden of ADRs. Those who are aware of this fact, fail to recognize the logistics of ADR reporting like who all can report, where to report what to report. Lack of knowledge attitude A large proportion of studies have found that the knowledge and attitudes of health care professionals appear to be strongly related with reporting. This result may have important implications in terms of public health, if knowledge and attitude are viewed as potentially modifiable factors. (5, 6) Lack of motivation Due to the passive nature of collection of reports, data collection is not exhaustive as it depends upon the attitude motivation of the clinicians. Hence, some ADRs even if observed are not likely to be reported. Some feel that reporting a single ADR wont help much in contributing! Fear of litigation loss of reputation Sometimes healthcare professionals fear that the acknowledgement of adverse reactions may reflect negatively on their competence or put them at risk of litigation. There is also a general fear of loss of reputation among the medical fraternity patients. Misconceptions about what to report Some are reluctant to report adverse reactions because of doubts regarding the causal role of the drug. There is a uncertainity in majority of the cases regarding the drug causing the particular adverse drug reaction. Unfriendly ADR reporting forms hassel of posting of the forms Some health care professionals fail to report due to the complexity of ADR reporting form. At any given instance of time all the information required to be filled is not available. Even after filling the form still there remains a hassel of posting of the forms. So, one always prefers to stay away from the problem. At times, difficulties in accessing the forms also contribute. Lack of time to report Excessive patient load in the health care set up in a developing country like India further worsen the situation. The other factors which contribute towards under-reporting include hesitation lack of confidence. Correcting for under-reporting is difficult because the exact magnitude of under reporting is unknown. It has been seen that more number of ADRs are reported spontaneously usually after a reminder or following scientific workshops, conferences or other awareness programs and it decreases gradually over a period of time. So sustainability is an important factor for determining the spontaneous reporting of ADRs. (3) In addition, it has been found that serious, unexpected ADRs those associated with newly marketed drugs are more likely to be reported. Easy access to ADR reporting forms, clarity of criteria for reporting, simple procedures and good motivational practices such as acknowledging the receipt of adverse drug reaction reports by personal letter or phone call, providing feedback to reporters in the form of articles in journals, adverse drug reaction bulletins or newsletters, organizing scientific workshops, trainings at regular intervals are all influential in addressing the problem. The periodic e-mail update on the safety of drugs represents an effective and inexpensive way to raise the awareness of clinicians on the importance of spontaneous ADR reporting. For continuous motivation there appears to be a need to adopt a policy of regular updates and educational strategies for health professionals. (4) There is an urgent need for regular training of all health care personnel in the form of workshops, symposiums scientific meetings. The training sessions must clarify the roles of the various healthcare professionals in pharmacovigilance. There should be closer relationship between the doctors and the pharmacovigilance centreââ¬â¢s. The paramedical staff should also be equally trained since they are in closer contact with the patients for a longer duration and can play an important role in making the pharmacovigilance programs more efficacious. Information analysis of the reported material is a highly specialized and complex job. It should be made as simple as possible by the use of appropriately trained staff, so that one may be able to provide an answer with greater certainty. Causality assessment scales are an example where there is need of improvement so that proper causal relationship between the drug and the adverse effect can be established. Appropriate training and educat ion regarding Pharmacovigilance should also be introduced during the formal teaching of medical graduates as a welcome step. Unfortunately, this activity is missing in our existing medical education system. Though we are now involving many of the medical colleges as Pharmacovigilance centreââ¬â¢s but still most of the undergraduates are unaware of this process. (7) The reporting of adverse reactions needs continuous stimulation. Therefore, it seems necessary to hold awareness programmes at regular intervals to improve the ADR reporting. It is important to achieve the development of a positive attitude towards pharmacovigilance among healthcare professionals so that adverse reaction reporting becomes an accepted culture in India. Vaccine Safety/Pharmacovigilance The goal of pharmacovigilance of vaccines is the early detection and timely response to adverse events following immunization, in order to minimize negative effects to the health of individuals and lessen the potential negative impact on immunization of population. A stringent safety surveillance of vaccines is crucial since the majority of vaccines are administered not only to vulnerable children but also to healthy population. Moreover, vaccines are complex biological products, which may include multiple antigens, live organisms, adjuvants, and preservatives which can be responsible for the ADRs. e.g. lymphocyte meningitis after anti-mumps vaccine. (8) So, each component has unique safety implications, which is important to capture as compared to other drugs. (9) In addition, difficulties in causality assessment in case of vaccines makes the situation more worse. (10, 11) Execution of Adverse Event Following immunization (AEFI) surveillance program in India is a challenge taking into account its large geographical area. Capacity to detect respond to AEFIs needs improvement in India. A multipronged approach is the need of the hour to ensure effective vaccine safety surveillance. Pharmacovigilance in clinical trials: A newer approach to patient safety in clinical trials Safety monitoring of drugs during clinical trials is now recognized as one of the major concerns for new drug development due to the increasing complexity of clinical trials involvement of large cohorts of participants. In a clinical trial, all adverse events experienced, irrespective of the causality should be monitored, accurately documented and adequately reported in a timely manner following the local regulatory requirements. Safety data from clinical studies is a key component that drug regulatory authorities consider in the decision-making as to whether to grant or deny market authorization for a drug. In addition, safety data from clinical trials helps not only in restricting harm at one centre but provides further vigilant action at other centres also. As per recent gazette notifications, Any unexpected serious adverse event (SAE) (as defined in GCP Guidelines) occurring during a clinical trial should be communicated promptly (within 14 calendar days) by the Sponsor to the L icensing Authority and to the other Investigator(s) participating in the study (Appendix XI In cases of any trial related injury, the safety data from clinical trials also serves as a basis for casuality aseessment for calculating compensation. Regarding reporting responsibilities of the investigators, Schedule Y states that: Investigator(s) shall report all serious and unexpected adverse events to the sponsor within 24 h and to the Ethics Committee that accorded approval to the study protocol with 7 working days of their occurrence. Pharmacovigilance in clinical trials needs to be encouraged and fostered. The present scenario requires reform and needs recommendations for building a robust safety surveillance system for clinical trials in India. Arora D. Pharmacovigilance obligations of the pharmaceutical companies in India. Indian J Pharmacol 2008 February , 40 (Suppl 1): S13-S16 Focused Pharmacovigilance HIV/AIDS, Malaria Kala-azar are major public health concerns in India. Adequate systems and infrastructure for ADR monitoring and risk management activities are largely absent in India, adequate national or regional quality and safety monitoring systems after drug distribution are also lacking. With increase in number of patients, availability of new drugs, generic fixed-dose combinations and the ignorance of pharmaceutical company sector in global pharmacovigilance activities, there is a great need of focused pharmacovigilance. In India, a total of 2.4 million patients were suffering from HIV/AIDS in 2009 and about 200,000 new HIV-positive individuals are diagnosed each year. (12) Antiretroviral therapy reduces morbidity and mortality in people living with HIV infection, but adverse drug reactions remain a potential barrier to treatment success as they are an important cause of poor adherence due to inability to tolerate antiretroviral therapy. ADR monitoring and causality assessment in resource-limited countries like India remain major challenges. In India, Post-marketing ADR monitoring often relies exclusively on spontaneous reporting which is a major issue. As of now there is no pre-existing surveillance system solely dedicated to ADR monitoring of anti- HIV/AIDS drugs in India. (13, 14) We can develop an HIV-focused pharmacovigilance program which can integrate both active and passive ADR surveillance for antiretroviral therapy (ART). Moreover integrating the HIV-focused pharmacovigilance program with the existing health care program of AIDS can go a long way. (15) As per WHO report 2011-2012, South East Asian Region bears the second largest burden of malaria (13%), only second to African region (81%). Among South-East Asia region, India shares two-thirds of the burden (66%) followed by Myanmar (18%) and Indonesia (10%). (16) Emerging chloroquine-resistance especially in P. falciparum is considered as one of the important contributing factors responsible for an increase in its occurrence in India. Because of this there is a wide scale use of Artemisinin based combination therapies (ACTs) and other new drug combinations. Our health systems have a very little experience with these new drugs. Pharmacovigilance for ACTs and other combination treatments in India is essential as malaria transmission is high and antimalarial drugs are used very frequently. Moreover, drugs can be obtained without a prescription. Informal use of antimalarial drugs may increase the risk of incorrect dosing, inappropriate treatment, and drug interactions which may impact negatively on drug safety. Furthermore, the administration of antimalarial treatments in patients with concomitant illness, including HIV/AIDs, tuberculosis and malnutrition, is a concern. So all these factors demand a focused pharmacovigilance activity to ensure sa fe use of antimalarial drugs especially the ACTs and other new drug combinations. (17, 18). In India Kala azar cases are mostly concentrated in Bihar, Uttar Pradesh, West Bengal and Jharkhand with over 165.4 million people at risk (19). Sodium antimony gluconate (SAG) and miltefosine are the first line drugs for the treatment of kala-azar are known to cause several side effects. Sodium antimony gluconate (SAG) has been known to cause anorexia, nausea, vomiting, abdominal pain, metallic taste in mouth, diarrhoea, pancreatitis, reversible elevation of liver enzyme activities, myalgia, arthralgia, proteinuria, ECG changes (T wave inversion,prolongation of QT interval, ST segment abnormalities), phlebitis, uveitis, optic atrophy, acute renal failure, hepatic necrosis and bone marrow hypoplasia. (20) Miltefosine is known to cause mild adverse effects which are mainly gastrointestinal in which loss of appetite, nausea and vomiting were found to be the major dose-limiting side effects. Other frequently observed miltefosine-related toxicities are mainly associated with the kidneys and liver. (21) Teratogenicity is the main limitation to the use of miltefosine which calls for responsible surveillance appropriate mechanisms to protect the women of child-bearing age. (22) In addition to the adverse-effects, quality of the generic products also need to be monitored. (23) In view of the current side effect profile other related issues monitoring of adverse effects to anti-leishmanial drugs is utmost. Focused Pharmacovigilance for anti-leishmanials can be integrated with the National Vector Borne Disease Control Programme (NVBDCP) which is an umbrella programme for prevention and control of vector borne diseases.
ââ¬ËMedicalizationââ¬â¢ in Current Health Policy
ââ¬ËMedicalizationââ¬â¢ in Current Health Policy Changing Public Health Priorities From Medicalization to Improving Built Communities Laura Schultz, Brett Weed, Ashini Fernando, Carolyn Moore,à Andrea Andersen, David Garcia Medicalization has greatly increased the emphasis on the delivery of clinical services to individuals, often at the expense of population-based solutions. We examine this phenomenon and offer an alternative that promotes public health by improving social, environmental, and physical determinants of health[HS1]. ââ¬ËMedicalizationââ¬â¢ in Current Health Policy ââ¬ËMedicalizationââ¬â¢ is the tendency for the practice of medicine to view a greater proportion of human behavior through a clinical lens (Zola, 1986). Among the examples of medicalization is the direct-to-consumer solicitation of prescription drugs for an arguably ever-increasing repertoire of conditions and afflictions (Frosch, Krueger, Hornik, Cronbolm, Barg, 2007) and increasing access to medical care as is evident through the initiatives implemented by the ACA[HS2]. Ever increasing amounts of money are being invested in treatment of chronic diseases, while a comparatively much smaller proportion is invested in preventing the same conditions (HHS, 2003). The United States spends more than 17% of their GDP on healthcare[HS3]. This per capita health expenditure is more than twice the average of countries of the Organization of Economic Cooperation and Development (Balding, 2014[HS4]), yet these numbers have translated not into better health but instead, a worsening trend in chronic diseases. US citizens also have significantly lower life expectancy in comparison (Woolf Aron, 2013). Despite these considerable investments in health care delivery, the costs associated with treating the manifestations of poor health continue to rise unabated. Over the last five years in North Carolina alone, approximately USD 80 million of the federal budget for public health was appropriated for primary care for the underserved populations (Trust for Americaââ¬â¢s Health, 2014[HS5]). Public Health Spending In contrast, public health only receives approximately 3% of the government budget and is underfunded (Balding, 2014). Nationally, 95% of health spending is for the apportionment of clinical services, while only 5% is invested in population-based solutions (Lantz, Licthenstein, Pollack, 2007). In North Carolina this division is even more extreme, with less than 1% of health spending dedicated to public health operations (Table 1[HS6]). Table 1. North Carolina Public Health Appropriations as a Percentage of Public Health Care Spending (Trust for Americaââ¬â¢s Health, 2014; Chantrill, n.d.) It is worth[CDL7] noting that the leading cause of mortality in the US, cardiovascular disease, accounts for annual healthcare costs that exceed USD $312.6 billion (HHS n.d.), yet when diagnosed early, disease progression can be addressed with non-pharmacological interventions[HS8]. In North Carolina, a mere 0.81% (~ USD 15 million, 2013) of the federal budget for public health was appropriated for prevention measures of all chronic diseases (Trust for Americaââ¬â¢s Health, 2014). These funding trends appear to support medicalization of health instead of prevention through public health efforts. Rather than continue to invest in a stopgap strategy of mitigating the impact of illness, we propose to instead invest in the prevention of illness[HS9]. Addressing Social Determinants Population health investments within corporate environments have shown considerable financial success and value beyond return on investment (ROI). One corporate wellness program saw a ROI of close to 300%; another company saved an estimated $224 per employee in 2003 dollars from promoting health rather than treating a lack of it (HHS, 2003[HS10]). Applying this same per capita savings rate to North Carolina, shifting funding to prevention and health promotion could yield savings of $2.2 billion annually[3], more than offsetting the annual increases in health services expenditures. Value beyond ROI includes physical and mental health, quality of life, perceived health status and functional capacity. Workplace well-being also promotes other intangibles such as increased social cohesion (Pronk, 2014). There is an established correlation between positive social relationships and health. As Robert Putnam wrote in 2000 in Bowling Alone, ââ¬Å"social capitalâ⬠conveys the essential health promoting value of communities[HS11]. It is defined as ââ¬Å"the social networks and interactions that inspire trust and reciprocity among citizensâ⬠(as cited in Leyden, 2003). Social isolation, independent of other lifestyle factors, is linked to premature death and decreased resistance to disease (Cohen, 2001). Beyond individual health, social capital is associated with political engagement, volunteerism, decreased crime rates and economic development (Leyden, 2003). Research has shown that when we design our communities to encourage social engagement there is a positive effect on the psychological and physical health of the residents (Leyden, 2003[HS12]). Since the advent of the automobile, the design of our communities has included limited transportation choices. Most individuals choose to travel by car because urban design has made most options for pedestrians unsafe (Vandergrift, 2004). The US, compared to other high income European countries with better health measures, have at least 25% more automobiles per 1000 people (Woolf Aron, 2013). European Countries also have policies which limit sprawl and prioritize ââ¬Å"urban centralizationâ⬠. Though difficult to quantify, these environmental factors are likely to contribute to the health disparities and disadvantages in the US (Woolf Aron, 2013). Political and social conditions and constructs, racism for example, also results in poor urban design that compound health disparities including limited access to businesses and markets, exposure to environmental toxins, and lack of opportunities for social participation. Specifically, infrastructure investment decisions, such as libraries, parks, public safety and maintenance are likely to be allocated to geographic areas populated by citizens with greater socioeconomic status and political power, which further marginalize disadvantaged socioeconomic groups (Schulz Northridge, 2004). Alternatively, mixed use, pedestrian friendly communities are based on thoughtful design and include intact town centers, multiple income residences and well linked streets that are designed for people, not automobiles (Walkable Communities, n.d.). Prioritized determinants of health, which we expect to improve because of innovative planning include increased social engagement, improved economic status and increased physical activity (Walkable Communities, n.d.). As of 2012, approximately 50% of the US adult population has been shown to suffer from chronic diseases. However, adequate physical activity has been scientifically proven to prevent or improve these chronic disease conditions[HS13]. Yet, according to a 2011 statistic from the CDC, 76% of adults did not meet the recommendation for muscle-strengthening physical activity which is a known risk for heart disease (CDC, 2014). There are states where the built environment is viewed as worthy of significant investment to improve population health. Specifically, in Massachusetts there are two examples of lower than average socioeconomic status communities where health impact assessments indicate that built environmental improvements would improve social factors and likely decrease expenses in medical intervention. In Somerville, there is a community driven planned change to a bisecting interstate. This plan, made with consideration for social health determinants of the residents includes multi use bike and walking paths with increased access to all areas of the community[HS14]. Community-wide access will provide opportunities for social interaction, physical activity and increased choices for employment (MassDOT, 2013). A community with similar demographics, Fall River, has proposed common trails for recreation and pedestrian and bicycle travel that connect residents to businesses. This is predicted to improv e every health determinant the HIA evaluated (MAPC, 2013). Based on a review of state sponsored health impact assessments in other communities, there is a significant relationship between communities with walkable pathways and health (Rails to Trails Conservancy, 2013). We propose that thoughtful environmental structure enhancements such as multi-use walking and biking paths will connect neighborhoods and businesses. In turn, we believe these changes will positively affect social cohesion, economic viability and physical activity, which are all key determinants of health that can improve with innovative public policy implementation[HS15]. Conclusion and Recommendations Evidence from state sponsored health impact assessments in other communities, indicates that there is a positive correlation between communities with walkable pathways and health (Rails to Trails Conservancy, 2013). Environmental structure enhancements such as multi-use walking and biking paths that connect neighborhoods and businesses could positively influence population health in North Carolina. We believe these changes will positively affect social cohesion, economic viability and physical activity, which are all key determinants of health that can improve with innovative public policy implementation. In North Carolina there are 31 completed Rails to Trails programs (NC Rails-Trails, 2014). This national program improves the built environment by converting former railroad routes to pedestrian and bike friendly paths. However, only 2 of the 31 completed trails are located in counties with the poorest health scores (RWJF 2014; NC Rails to Trails, 2014). Eastern North Carolina, where 9 out of 10 of the most poorly rated counties for health outcomes are located, also have the fewest trail initiatives (NC Rails-Trails, 2014). This skewed distribution of environmental improvements further demonstrates the way in which populations within poor socioeconomic communities are financially neglected, and thus likely to continue to suffer from worse health outcomes. Using Massachusetts as an example, the stateââ¬â¢s Department of Health and Human Services has initiated a program to identify communities with the lowest socioeconomic status and assist them to ââ¬Å"build policies, systems and environments that promote wellness and healthy livingâ⬠(MassDOT, 2013). In partnership with state and county planning officials, public health leaders, and state demographers, our plan is to target lower socioeconomic communities, initially focusing on a county with the poorest health indicators, to plan and build multi-use trails. We request priority funding allocated through the US Department of Transportation via the Moving Ahead for Progress in the 21st Century ACT (MAP-21), as well as private foundation grants that prioritize state population health improvements like the Annie E. Casey and Doris Duke foundations. Our plan for advocacy is to engage community members in the trail project as stakeholders. Specifically we will encourage our members to influence policy decisions through community informational meetings, including letter writing assistance intended to exert pressure on local politicians. We intend to host community or health center ââ¬Å"coffeesâ⬠with opportunities to meet county commissioners and planners. Media coverage in the lo cal newspaper is another part of our advocacy plan. Specifically, we will engage local media in an effort to ââ¬Å"frameâ⬠the problem of poor environmental design and how it impacts health by profiling one citizen with health risks and limited transportation options who lives on a pedestrian unsafe street, visually depicting the social isolation inherent in this environment though a photo layout[HS16]. By engaging our most vulnerable North Carolina citizens to take part in improving their quality of life and ultimately their health and longevity, we will have the best chance at community environmental improvement as a long term effort. The time is now to refocus our priorities on health investment through prevention and promotion of public health efforts rather than treatment of diseases. References Blanding, M. (2012). Public Health and the U.S. Economy. Retrieved from http://www.hsph.harvard.edu/news/magazine/public-health-economy-election/. Chantrill, C. (n.d.). North Carolina Government Spending Chart. Retrieved from http://www.usgovernmentspending.com/spending_chart_2003_2019NCb_16s1li111mcn_13l14t Centers for Disease Control and Prevention (2014, October). Chronic Disease Prevention and Health Promotion. Retrieved from http://www.cdc.gov/chronicdisease/overview/index.htm. Cohen, S (2001). Social relationships and health: Berkman syme (1979). Advances in mind-body medicine. 17(1):5-7. Frosch, D. L., Krueger, P. M., Hornik, R. C., Cronbolm, P. F., Barg, F. K. (2007). Creating Demand for Prescription Drugs: A Content Analysis of Television Direct-to-Consumer Advertising. Annals of Family Medicine, 5(1), 6-13. Lantz, P. M., Licthenstein R. L., Pollack, H. A. (2007). Health policy approaches to population health: The Limits of medicalization. Health Affairs, 26(5), 1253-1257. Leyden, K. (2003). Social Capital and the Built Environment: The Importance of Walkable Neighborhoods. American Journal of Public Health, 93(9), 1546-1551. Massachusetts Department of Transportation. (2013). Health Impact Assessment of the Massachusetts Department of Transportation (MassDOT) McGrath Grounding Study. 2013. Retrieved from http://www.massdot.state.ma.us/groundingmcgrath/HealthImpactAssessment.aspx. Metropolitan Area Planning Council (MAPC) (2013). Health Impact Assessment: Quequechan River Rail Trail Phase 2. Retrieved from http://www.mapc.org/quequechan-river-rail-trail-hia. NC Rails-Trails (2014, September). Resources. Retrieved from http://www.ncrailtrails.org/web/resources. Pronk, N. P. (2014). Placing Workplace Wellness in Proper Context: Value Beyond Money. Preventing Chronic Disease 11, 1-4. http://dx.doi.org/10.5888/pcd11.140128 Putnam, R. (2000). Bowling Alone: The collapse and revival of American community. New York: Simon Schuster. Rails to Trails Conservancy. Health and Wellness Benefits. (n.d.). Retrieved from http://www.railstotrails.org/ourWork/trailBasics/benefits.html. Robert Wood Johnson Foundation (2014). County Health Rankings and Roadmaps, Building a Culture of Health County by County; 2014 Rankings; North Carolina. Retrieved from http://www.countyhealthrankings.org/sites/default/files/state/downloads/CHR2014_NC_v2.pdf Schulz, A., Northridge, M. E. (2004). Social determinants of health: Implications for Environmental Health Promotion. Health Education and Behavior, 31(4), 455-471. Trust for Americas Health (2014). Key Health Data about North Carolina. Retrieved from http://healthyamericans.org/states/?stateid=NC#section=3,year=2009,code=undefined US Census Bureau (2014, July 8). NC quick facts. Retrieved from http://quickfacts.census.gov/qfd/states/37000.html US Department of Health and Human Services (HHS) (2003, September). Prevention makes common ââ¬Å"centsâ⬠. Retrieved from http://aspe.hhs.gov/health/prevention/. US Department of Health and Human Services (HHS) (n.d.). About Heart Disease Stroke. Retrieved from http://millionhearts.hhs.gov/abouthds/cost-consequences.html#cost. Vandergrift, D., Yoked, T. V. (2004). Obesity rates, income, and suburban sprawl: an analysis of US states. Health Place, 10, 221-229. Walkable Communities, Inc. (n.d.).Walkable Communities FAQ. Retrieved from http://walkable.org/faqs.html. Woolf, S. H., Aron, L. Y. (Eds.). (2013). U.S. Health in International Perspective: Shorter Lives, Poorer Health. Washington DC: National Academies Press. Zola, I. K. (1986). Medicine as an institution of social control. In P. Conrad R. Kern (Eds.), The sociology of health and illness. New York: St. Martins Press. [1] Rounded to nearest million [2] Rounded to nearest ten million; represents NC state and locality public health care spending [3] Based on 2013 NC Population Estimate of 9,848,060 (US Census Bureau 2014). [HS1]Nice introduction to your paper [HS2]Good examples [HS3]Is this from your Balding reference? This statement needs to be referenced. [HS4]This is listed as Blanding on your reference list. [HS5]Very nice section, your reader will have a good understanding of medicalization after reading this section [HS6]Great reference and statistics that support your premise [CDL7]Do not use this construct in this class, ââ¬Å"it isâ⬠, ââ¬Å"there areâ⬠, etc. [HS8]Such as implementing lifestyle changes with diet exercise. [HS9]Very good! [HS10]Impressive! [HS11]Very interesting, I will be reading this. [HS12]Great examples and points being made, excellent references. [HS13]You need a reference here [HS14]This entire section isnââ¬â¢t referenced. Unless this information is considered to be ââ¬Å"common knowledgeâ⬠e.g. it came from your own brain or was information you were aware of prior to writing this paper, it needs to have a citation. Please review when to cite from UNC library http://www2.lib.unc.edu/instruct/citations/index.html?section=why_we_cite [HS15]Great ideas [HS16]Great ideas and plan of action
Saturday, July 20, 2019
To Have Or Have Not :: essays research papers
To Have and Have Not Michael Lind Michael Lind wrote the article To Have and Have not about the ever-increasing gap between the rich and the poor. He comments with heart and knowledge on the fact that the prosperous are increasing their wealth by taking from the poor. It sounds like and basically is the story of Robin Hood. He writes about the amount of power the wealthy have, segregated work places, the crooked political system, and tax reforms. But what amazes me the most is that he too is part of the overclass. This first hand knowledge of the system gives Lind such a strong base for his argument, and allows the reader to trust his words that much more. Over the last several years in the United States it has become more and more evident that the gap between the rich and the poor is growing. Not only is the gap growing, but the government is doing very little to stop it. Slowly the poor are being shifted away from the center of wealth and being replaced by the already wealthy. It's a shame how a few people with large cheque books can run the most powerful country in the world, and yet the general public are being redirected to think this problem is a minimal and insignificant issue. The truth is that economic and social inequalities have been growing in the United States at an alarming pace. The inequalities exist because the wealthy want to have more, and the power to obtain more; To do so people must give up their wealth and thus cause the economic gap. Not only is the United States segregated based on the upper class and lower class, it seems that prejudice is also appearing in a hidden manner. Take for example an executive building. You'll notice that everyone working there looks the same. Of course their opinions, value systems, and beliefs may differ, however they are almost always white and mainline protestant. This new and still growing oligarchy is about 20 percent of the population and is evenly spread across every state. What is even more amazing about the American oligarchy is that they pride themselves solely on their individual merit. To them its not because they were born into upper class, nor that they had the opportunity to get an education, but merle on their own IQ, virtue, and genius. Lind uses a great example of this when he says,
Friday, July 19, 2019
A Political and Cultural History of Jamaica Essay examples -- essays r
Situated just south of Cuba in the Caribbean Sea, Jamaica is well known as a popular tourist spot and the birthplace of reggae music. Populated initially by native Arawak Indians, who gave the island its name, ââ¬Å"land of wood and water (Jamaica).â⬠However, this beautiful landââ¬â¢s almost pristine beauty was shattered by outbursts of violence surrounding the 1980 political elections. This fighting was sparked by the peopleââ¬â¢s mistrust of the ruling socialist party at the time. The reasons for this fighting and this mistrust are not simple, they are intrinsically tied to the island nationââ¬â¢s history from the beginning of its colonial period five hundred years before. The island was first discovered by Christopher Columbus on his second voyage in 1494 and became a colony of Spain in 1509. They founded the town now known as Spanish Town and it was the capital of the island until the 1800s. Under the Spanish, the native Arawak Indians died out because of slavery and disease, and Africans were brought in to work in their place. The Spanish ruled the country until 1655 when Sir William Penn of the British captured the colony by force. It was later tuned over legally under the Treaty of Madrid in 1670(Jamaica). Once the British gained control of the island, development was swift. The industries of sugar cane and other agricultural resources were increased, thus creating a larger demand for African slaves. Due to this explosion of growth in the late 17th century, Jamaica became one of the largest slave trading centers in the world. The slave trade was conducted out of the city of Port Royal, made famous for being a hideout of the pirate Blackbeard, until the city was destroyed by an earthquake in 1692. The destruction of Port Royal led to th... ...arty). The nation of Jamaica has had a rich cultural and political history. From the islandââ¬â¢s days as a colony up until today it has proven that its people are resilient, passionate, and have an extremely high level of national pride. IT has been shown that the violence that marred the election of 1980 was not due to the governmentââ¬â¢s brief flirtation with communism, but with more underlying issues. It has been shown that the history of the island has been impacted by several instances of similar violent outbursts resulting from a public feeling of frustration with the rulers at the time. From the time of Bustamante on into the 80s and 90s, the balance of power has shifted because of severe public dissatisfaction with the party in power. It is unknown whether or not this cycle will continue, but as of today, the threat of violence in Jamaica is a very serious one.
Thursday, July 18, 2019
Nintendo Company Ltd Essay
ââ¬Å"Nintendo Company Ltd .was founded in 1889 as a producer of Japanese playing cards, but by the 1980ââ¬â¢s the corporation had turned its attention towards the production of video game hardware and softwareâ⬠. ââ¬Å"Since then, Nintendo has gone on to become the third most valuable company in Japan selling more than 470 million home game consoles and handhelds as of 2009â⬠. Nintendo was founded by Fusejiro Yamauchi the great grandfather of the current president of Nintendo.â⬠Nintendoââ¬â¢s products arose in the mid-1980s from the relative obscurity of the amusement arcade to change the concept of home entertainment in both Japan and the United Statesâ⬠. Strengths: Nintendo ââ¬Å"strongly established brandsâ⬠, ââ¬Å"robust revenue growthâ⬠, ââ¬Å"strong cash flow from operations, and ââ¬Å"Nintendo derived most of its revenue from the video game business, Nintendo was in the lead in video consoleâ⬠(pg.C269). Weakness: Nintendo weakness is ââ¬Å"Inventory shortagesâ⬠.â⬠Nintendo was unable to meet demand during 2007 and also struggled throughout 2008â⬠.â⬠In an interview on the website Game Theory, Perrin Kaplin, Nintendo vice president of marketing and corporate affairs, suggested that shortages were expected some timeâ⬠. ââ¬Å"We are at absolute maximum production and doing everything we canâ⬠¦but demand continues to be really highâ⬠(pg.C273). Also Opportunities: ââ¬Å"Rising demand for companyââ¬â¢s products and related softwareâ⬠, ââ¬Å"growing US games software marketâ⬠, and ââ¬Å"increasing demand for online gamingâ⬠. Threats: ââ¬Å"Short products lifecycleâ⬠, ââ¬Å"slowdown of the Japanese, the US, and European economiesâ⬠. ââ¬Å"The five forces may be interdependent i.e. pressures from one direction can trigger off changes in another dynamic process of shifting sources of competitionâ⬠. ââ¬Å"Industry rivalry here occurs in the strategic alliances i.e. battle to control marketâ⬠. ââ¬Å"With huge players like Sony, Nintendo and Microsoft there is a tuff battle between companies to dominate the marketâ⬠. ââ¬Å"The threat of entrants into the industry can be negligible with the existence of players like Sony, Nintendo and Microsoft etcâ⬠. ââ¬Å"There can be no substitute to the video gamesâ⬠. ââ¬Å"The Power of Buyers in the video game industry is low as there are very few successful companies in the video game industry, therefore a small variety of video games available to the buyersâ⬠. ââ¬Å"On the other hand, the Power of Suppliers is very high as there are more suppliers available to a handful of companies in the video game industryâ⬠. ââ¬Å"Nintendoââ¬â¢s goal was to create games that everyone could play and a system that would appeal to women and people who had never played video games in the pastâ⬠(pg.c273). Nintendo used the three generic strategies: overall cost leadership, differentiation, and focus. Nintendoââ¬â¢s strategy was to attract and target all age groups also to make the Wii easy to use whether the player is skilled or a novice. Nintendo was successful at this strategy because ââ¬Å"According to Nintendo, one of the key differences between the Wii and the competitiorsââ¬â¢ systems was the broad audience that the Wii targetedâ⬠(pg.c273). ââ¬Å"Many of the Wii games were able to be played by all people of all ages, and they were easier to control than the complicated controllers of the Sony Playstation 3 or Microsoft Xbox 360â⬠. Nintendoââ¬â¢s TV commercials of the Wii showed people of different ages and social classes playing the Wiiâ⬠(pg.c273). Yes I believe all companies can use the strategy of attracting all age brackets with unique products that are easy, fun to use, and affordable. The Nintendo competitive strategy are that the make their consoles cheaper to manufacture. They can sell the base console at a profit while their competitors have to subsidize the retail price. It also gives Nintendo far more room to maneuver when it comes to using the price mechanism to take on that competition. Nintendo will be able to sustain their competitive advantage if they lack in supply of product with a high demand. What Nintendo need to do is maintain their supply so that it will be able to keep up with their competitors and keep clientele. This is the problem they are having which is a high demand for product with low supply. I believe Nintendoââ¬â¢s strategy has good intentions, if I was in position to advise Nintendo of their strategy is will be to change is their supply and demand. If you have a low supply of product how do you expect to make profit? I would advise them to make sure that there is a high supply of products to keep customers happy because there is a great possibility that the company can lose clientele to other competitors. Some customers go great lengths for entertainment and some will pay any price to have it. Nintendo needs to keep their ratings up along with the other companies that are competing and the only way to do that is to make sure that the products are available and the prices affordable. This was an interesting case to work on and I hope I did a good job. I had no idea Nintendo was founded in 1889, I thought it invented in the 1980ââ¬â¢s. After reading this case I know that even the popular companies sometime struggle in certain areas. I have a Nintendo Wii and even though I donââ¬â¢t get to play it often but when I do itââ¬â¢s so much fun. The Nintendo Wii is definitely for all ages like it was mentioned in the case. From reading the case and doing research online helped me learn about how Nintendo was founded and their timeline of products. I learned about their rivalry with Sony, Microsoft, and their struggles with supply and high demand. How However Nintendo Wii price was reasonable compared to the playstation3 and xbox. I believe what attracts customers to the Nintendo Wii is that as far as I can remember Nintendo always included a free game with the console which Sony and Microsoft does not provide. My opinion Nintendo strategy has good intentions but to be the better competitor Nintendo needs all their areas to be strong especially their supply of products. Even if it means to hire more employees or outsource jobs to keep products in stock they should go that extra mile to keep their customers happy.
Itt Tech Comp. Ii Final Paper
Course Project resignation The Legalization of ganja J. Doe ITT practiced Institute March 7, 2013 Composition II Dr. Sue Introduction ganja should be legalized. That is the decision every champion in our group has conform to to. We believe the pros of marijuana call greatly knocked out(p)number the cons, and that the organization needs to read that. Defending either expression of this object is real quite difficult. Any studies that you whitethorn find can be dis canvassn by studies performed from the opposition and vice versa. Still, we energize non found anything that has even came close to changing our opinions.Medical Use some studies arouse been performed that prove marijuana can avail with the preaching of many an(prenominal) a nonher(prenominal) types of cancers. Metastasis is when cancer cells spread from one circumstances of the body to another (Mandal, n. d. , What is Metastasis). Scientists at California Pacific Medical essence have found a complica ted in marijuana that can actually stop metastasis. This compound is called Cannabidiol. They learned this initiatory by testing the compound on animals that had cancer and have proven that it works. They atomic number 18 now waiting on plaudit to begin human testing (Wilkey, 2012, Marijuana and Cancer).It can to a fault be wont to replace many agony pills that deadening our kidneys and cause major addictions. Studies commemorate that bullet marijuana can help decrease nerve cark or pain caused by surgery. about 10% to 15% of patients attending a chronic pain clinic use cannabis as part of their pain control strategy(Doheny, 2010, Marijuana Relieves Chronic Pain). Lower Crime rank In 2011, after legalizing marijuana in California, the juvenile crime rate dropped 20 part. The number of arrests for violent crimes dropped by 16 sh ar, homicide went down by 26 percent and drug arrests decreased by roughly 50 percent.In 2010, marijuana possession placarded for 64 percent of all drug arrests, and in 2011, that number decreased to only 46 percent (Sankin, 2012, California Marijuana Decriminalization). Many pile believe that drug dispensaries would withdraw crime. A study has shown that crime actually seems to be much less serious the dispensaries then in the aras where dispensaries have been closed. On the blocks with closed dispensaries, crime was 60% greater within a three-block radius, and 25% greater within a six-block radius than on the blocks with open dispensaries, according to the study (Shaw, 2011, nurture Show Lower Crime Rate).A amend Economy There are many ways legalizing marijuana can help the economy. Marijuana-related charges would fall significantly, saving US prisons around $1 zillion annually. Ending banishment laws against marijuana would save taxpayers $41. 8 billion annually. Marijuana growers in California account for $14 billion a grade now that is legalized at that place. The selling of marijuana illegally is a $38 billion constancy which is money our government is missing out on (Bradford, 2012, Boost the Economy). Physical Dangers to UsersThere are many studies that show marijuana use can greatly impair a users motor skills. They have shown that these impairments lead to a much high-pitched rate of vehicle accidents even though people think being high has nothing to do with it. Studies have in any case shown that the constant inhalation of smoke, whether it is tobacco or marijuana, can lead to cancer. There has also been a link of marijuana use to psychosis, anxiety, and panic attacks (Lipkis, 2012, Impaired Driving Skills). A Worse Economy Polls show that many people do not believe legalizing marijuana would boost the economy. About a quarter of those polled verbalize legalized draw would lead to more than jobs in their communities 57 percent said in that location would be no effect. About a trinity thinks the economy would improve, while 46 percent foresee no impact (Grisling, 201 0, impart NOT Boost Economy). In fact, many people think it will betray things worse. This is because while marijuana dispensaries are favored, there are not many people that would invest in them. If marijuana was decriminalized, more Americans favor private businesses selling it (54 percent) than the government (36 percent).But just 24 percent said they would be interested in investiture in a company that sells potty (Grisling, 2010, Will NOT Boost Economy). finishing The legalization of marijuana is, in our opinion, a good thing. Many people have benefitted from using marijuana even if there are some undesirable side effects. Moderation is something that needs to be applied. Whether it be marijuana or even exercising, alike much can hurt you. amateurish use is not what was discussed here. Improving upon the lives we are currently living, through the different applications of marijuana, is what we aimed to lead out.
Wednesday, July 17, 2019
Clinical Educational Experience Essay
Educating the family and or the residential district is a role that every keep must(prenominal) participate in to promote, maintain, and recuperate wellness among them. To accomplish such requires family members foregather and shit a practical misgiving of health-related in general anatomyation. One method to accomplish such is to develop a health bringing upal plan. The health reading plan establish upon information collected from a windscreen survey and Friedman family assessment conducted, Areas that will be discussed take on, a description of the educational fill based upon assessment findings, educational goals and objectives, educational methods that will be used to enforce the health educational plan, and the methods applied to quantify the educator and process used in the development and implementation of the health education plan.I also include the health tools used to educated family, and Identification of a Health Educational Need. MBG elderly diabetic type I, smoker, strike, demanding, uncaring, undetached from the family. JBG also elderly grim and heavy drinker, son flat reach with family, dysfunctional family. Cultural, religious, ethnic, and in the flesh(predicate) upbringings be variables that ar considered to gain a basic discernment of the family textile. Being old fashion knockout cord Catholic is hard to aim them understand that what you preach in the participation you have to practice at home. correspond to NANDA, Nursing diagnosis for this family that I have encounter 1) Impaired verbal intercourse as evidence by controlling, undermining from contract and want of family connectedness. 2) Stress overload evidence by busy work day, lack of time to relax, and sleep deprivation, and 3) Risk for self-annihilation as evidence by stimulate excessive drinking and mopping some(a) wondering what is the point.Resolutions as follow 1) lay out common goals, complementary roles, and ongoing structural relationships be tween the health provider and family members, family charge and individual counseling. 2) Mental health is indwelling to a persons well-being, healthy family and interpersonal relationships, and the ability to live a full and productive life. People, stress with untreated mental health disorders are at high risk for many membrane-forming and unsafe behaviors, including alcohol or medicate abuse, violent or self-destructive behavior, and suicide. pamphlet was given to the family, Stress overload and essay to cover depression and communication into the education knowing that dinking, depressing, and risk of suicide are very touchy subjects. Family was hesitant at the beginning but did pay attending and glanced over brochure gave them names of hospital and web site that they can heft for help. Nurses must be conscious of their responses and actions that may inadvertently affect the patients response.Jean Watsons Theory of gentle Caring uses a contemporary, holistic framewor k designed by using nonuple disciplines to care for individuals and those within a community. So as a nurse we must be always be considerate about of the family as whole and include the community that will be affected. A learning motivation based upon personal need. The adults motivation to learn is derived from the developmental needs of the individual. The adult comes into an educational activity largely because he is experiencing some inadequacy in coping with flow life problems (Knowles, 1972, p. 36).ReferencesDepression and how to help out. Retrieved from www. http//lib.calpoly.edu/ sustain/how-to/find-articles/Depression.Healthy People 2020.gov (June, 2014) US plane section of Health and Human Services retrieved from http//healthypeople.gov/2020/LHI/injuryViolence.aspx Knowles, M.S. (1972). Innovations in teaching styles and approaches based upon adult learning. daybook of Education for Social Work, 8, 2, 32-39.Nanda nursing diagnosis Care Plan/Nursing diagnosing/ Nursing Diagnoses List 2013 retrievedFrom www.nanda.orgNursing diagnosing Handbook, 9th Edition By Betty J. Ackley, MSN, EdS, RN and Gail B. Ladwig, MSN, RN ISBN 9780323089210, copyright 2014, Mosby.The Friedman family assessment model form retrieved from https//portal.phonex.edu/mediallibrary/embedreader.urnisbn9780130608246 friedman University of Illinois library. Retrieved fromhttp//openurl.library.uiuc.edu/sfxlcl3?rft.object_id=17160000000000289&svc.fulltext
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