Posts Tagged “Answer”
Question by rashrash27: Please help me answer the following question ASAP?
A well-known pharmaceutical company, Robins & Robins, is working through a public scandal. Three popular medications which they sell over-the-counter have been determined to be tainted with small particles of plastic explosive. It has not yet been determined where the plastic explosives came from, but over $ 8 million in inventory is impacted. The inventory is located throughout the Western United States, and it is possible that it has also made its way into parts of Canada. A recall occurs but it is mostly unsuccessful.
Last fall, the FDA had promulgated an administrative rule which stated that all pharmaceutical companies which sold over-the-counter medications must incorporate a special tracking bar code (i.e. UPC bars) on all packaging, to ensure that recalls could be done with very little trouble. This bar code would have cost about $ .35 (cents) per package, which would have cost the company nearly $ 3 million on this batch of inventory.
Robins & Robins lobbied hard against this rule, and managed to get it stopped in the public comments period. They utilized multiple arguments, including the cost (which would be passed on to consumers). They also raised “privacy” concerns, which they discussed simply to get public interest groups upset. (One of the drugs impacted is used for assisting with alcoholism treatment – specifically for withdrawal symptoms and many alcoholics were afraid their use of the drug could be tracked back to them.) Robins & Robins argued that people would be concerned about purchasing the medication with a tracking mechanism included with the packaging and managed to get enough public interest groups against the rule. The FDA decided not to impose the rule.
The FDA decides to require all pharmaceutical companies to immediately implement the tracking bars (UPC) as a result of the disaster with Robins & Robins. Robins & Robins decides not to challenge this and begins the process of adding them to all of their products. However, McFadden, Inc., a New York pharmaceutical realizes that this new requirement is going to bankrupt them immediately. McFadden did not participate in the original public comment period. However, this rule
is different from the rule which went through that public comment period, in that it specifically names 4 companies as being impacted, Robins & Robins, McFadden, Inc., Bayer, and Johnson & Johnson. On what bases can McFadden challenge this requirement imposed by the FDA? Provide at least two bases under the Administrative Procedures Act. Would the injuries from the Robins & Robins situation impact the chances that this challenge would be successful? Why or why not?
Question 2, please help me ASAP
It is discovered that Robins & Robins knew about the tainted medication two months earlier than they announced the recall. They hid it, and in fact, sent out contract buyers to try to buy up all of the medication off the shelves. Their “fake” recall failed. Using the Laura Nash method of analyzing ethical dilemmas, analyze the ethical dilemma faced by the CEO of Robins & Robins for the fact that they saved 35 cents/package and are now in the middle of a major, life threatening recall. Analyze their “fake” recall as well. Show all of the steps of the model and give a recommendation to the CEO of what to do now that the deaths are escalating. What is the “right” thing for the CEO to do in this case? Did the model help you come to this conclusion or did you use some other method? Explain.
Best answer:
Answer by STEPHEN McFadden can challenge the requirement by asserting the cost element and that its implementation would bankrupt them and make the same arguments that Robins & Robins made. Additionally, they could argue that the FDA is estopped by its prior decision to not impose the Rule; this, of course, could be countered by the argument that McFadden waived all arguments against imposition of the Rule by its failure to participate in the earlier public comment period. McFadden could also argue that the FDA is over-reacting to a calamity which could not be foreseen and is so rare an occurrence that it is highly unlikely to happen again, to which the FDA would contend that its statutory authority compels that it impose the Rule. The injuries of the Robins & Robins matter would be the only significant impact which would cause the imposition of the Rule. The two bases: (1) It would not be an abuse of discretion to impose the Rule. (2). The FDA may lawfully take administrative notice of the Robins & Robins calamity.
What do you think? Answer below!
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I’m a 26 year old male and usually only drink on the weekends. I partied pretty hard this weekend and I’m getting a little discomfort from the upper right side of my abdomen. I’m pretty sure my liver is recovering. Have any of you experienced this? Is this a sign I should stop drinking and if the discomfort continues to see my docter?
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Match the term with its definition.
regular health care provider such as a family physician
counselor
American Society of Addiction Medicine (ASAM)
clergy, religious educators, and church administrators
Employee Assistance Professionals (EAPs)
Al-Anon and Alateen
State Alcohol and Drug Abuse Authority
Substance Abuse Professionals (SAPs)
A. physicians should be certified by this Association to treat substance abuse and addiction.
B. this is where you should start in your search for help for substance abuse
C. this program is available in companies with as little as 10 employees and as large as 10,000 employees. It is a confidential resource used and trusted by millions of people each year.
D. these programs provide support for friends and families of people with substance abuse problems.
E. this person should be licensed to treat drug and alcohol addictions. Your doctor may refer you to one with a good reputation in your area.
F. these people have counseling skills but may not necessarily be licensed counselors. They may be able to provide assistance or advice.
G. if you are seeking help from a treatment center, make sure they are approved by this organization.
H. counselors that are individually certified to treat substance abuse and addiction.
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Improving Patient Care
Race and Preventive Services Delivery
The way to eliminate disparities may be to improve access to family physicians.
Robin S. Gotler, MA, Robert L. Williams, MD, MPH, Susan A. Flocke, PhD, George E. Kikano, MD, CPE, Kurt C. Stange, MD, PhD
Because many racial minority groups have disproportionately high rates of preventable health problems, the issue of disparities in the delivery of preventive services is of particular concern. A number of studies focusing on the population at large suggest there are racial disparities in the delivery of preventive services. However, there has been little direct study of this issue in primary care settings, where most preventive services are provided. This lack of research led us to investigate the following question:
Do racial disparities in preventive service delivery occur among patients seeing family physicians?
Study results
To learn more about the relationship between race and preventive service delivery in family practice, we analyzed data from the Direct Observation of Primary Care (DOPC) Study. By directly observing 4,454 patient visits to 138 family physicians in Northeast Ohio, the DOPC Study sought to better understand the inner-workings of family practice. For this analysis, we examined the delivery of preventive services to both African-American and white patients. These services, recommended by the U.S. Preventive Services Task Force, included screening services (such as blood pressure checks, mammography and sigmoidoscopy), immunizations (such as DPT, tetanus and flu vaccinations), and health habit counseling (on topics such as diet, sexually transmitted diseases, tobacco, alcohol and drugs).
ILLUMINATING THE ‘BLACK BOX’ OF PRIMARY CARE
This article continues our series on the Direct Observation of Primary Care (DOPC) Study, which was funded by the National Institutes of Health and conducted by the Center for Research in Family Practice and Primary Care, with support from the AAFP. The study demonstrates the complexities of the patient visit, the demands of real-world practice and the value of primary care, issues that policymakers, the public and even clinicians have not fully understood.
The study found that, within family practices, African-American patients and white patients were equally “up-to-date” (i.e., equally likely to receive services within the recommended periods) on both screening and immunization services. However, African-American patients were significantly more likely than white patients to be up-to-date on health habit counseling. These findings stand in stark contrast to studies of the general population, in which African Americans receive fewer recommended services.
Take-away lessons
Access to care within the family practice setting appears to play an important role in reducing disparities in the delivery of preventive services. These results support calls for improving quality of care by increasing the population’s access to primary care. They also suggest that access to family practice and primary care must be a key component of any effort to ensure racial equity in the delivery of preventive services.
Williams RL, Flocke SA, Stange KC. Race and preventive services delivery among black patients and white patients seen in primary care. Med Care. 2001;11(39):1260-1267.
Robin Gotler is project coordinator in the Family Medicine Research Division of Case Western Reserve University/University Hospitals of Cleveland. Dr. Williams is an associate professor of family and community medicine at the University of New Mexico, Albuquerque. Dr. Flocke is an assistant professor of family medicine and epidemiology and biostatistics at CWRU. Dr. Kikano is an associate professor and acting chairman of family medicine at CWRU. Dr. Stange is a professor of family medicine, epidemiology and biostatistics, oncology and sociology at CWRU. He is also director of the Center for Research in Family Practice and Primary Care, one of three family practice research centers funded by the AAFP. Conflicts of interest: none reported
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went I went to intake counseling for alcohol they asked me a ton of ?’s..one was have I ever had a gay experience..which was no and the other have I ever been in a gay relationship?…I ‘m sorry but it sleighed me and I answered”not yet”…I am curious to know why they would ask such things..I happen to have a pretty cool aunt who is gay and she doesn’t drink..so are they trying to say if you are a homesexual you have drug issues..I was and still am offeneded..not because I have somethingg against gays..but because I don’t.
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