Replies 19460303

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1-AG 

                                                    Process and Regulations of Fast Track

    New pharmacological agents go a long way in clinical trials and approvals from the Food and Drug Administration before entering a wide market and becoming available to needy patients in the United States. At the same time, for promising drugs that can significantly improve the results of existing therapy or fill a missing niche, this process can be accelerated using the Fast Track protocol (Woo & Robinson, 2015). The latter provides for the filing of a special application by a pharmacological company at the FDA office, which the latter examine within 60 days. If the medicine acquires Fast Track status, manufacturers receive a number of concessions, such as the right to more frequent correspondence and meetings with representatives of this state regulatory body and the possibility of cooperation in conducting a clinical trial. If convincing positive results are obtained, it is possible to obtain FDA approval after a single phase 2 clinical trial (Papadimitriou & Butler, 2017). In addition, the verification process of such a pharmacological agent is significantly reduced from 10 to 6 months.

                                                                    Medical Conditions

    In order to be able to obtain faster approval via the Fast Track protocol, the drug agent must meet a number of requirements. Specific medical conditions are not indicated, but it is prescribed that the effect of the drug should be aimed at treating a life-threatening or dangerous disease, such as heart failure (Papadimitriou & Butler, 2017). A prerequisite is either to improve the outcome of existing treatment, such as a reduction in mortality or disability, or a significant reduction in the toxicity of therapy (Woo & Robinson, 2015). In addition, medical conditions that do not have developed a pharmacological treatment, such as some rare and orphan diseases, are also eligible for faster approval from the FDA via the Fast Track protocol. Therefore, due to this possibility, patients will more quickly gain access to the most modern therapy and increase the chances of a more favorable outcome of treatment.                                                   

                                                                           References

Papadimitriou, L., & Butler, J. (2017). “Fast Track” Development and Approval Process for Heart Failure Therapeutics. Clinical Pharmacology & Therapeutics, 102(2), 184-186.

Woo, T. M., & Robinson, M. V. (2015). Pharmacotherapeutics for advanced practice nurse prescribers. FA Davis.

2-MV

The FDA made it possible for critically needed medications to be introduced to the US market promptly using the “Fast Track” procedure.  “Fast Track” is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need (Vaggelas & Seimetz, 2019).  With fast track, FDA is required by the statute to decide within 60 days of receipt of the request whether the conditions for fast track designation have been met (Vaggelas & Seimetz, 2019).  To be eligible for the fast track program, an applicant must submit a request with supporting documentation for fast track designation for the product and its proposed use (Darrow, Avorn, & Kesselheim, 2018).

The medical conditions that warrant “Fast Track” drugs are serious or life-threatening conditions and those conditions that result in unmet medical needs (Darrow et al., 2018).  Determining whether a condition is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one.  Stroke, epilepsy, brain disorders, depression, AIDS, Alzheimer’s, heart failure, diabetes, and cancer are examples of serious conditions.  Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy (Darrow et al., 2018).

References

Darrow, J. J., Avorn, J., & Kesselheim, A. S. (2018). The FDA breakthrough-drug designation-four years of experience. N Engl J Med, 378(15), 1444-1453.

Vaggelas, A., & Seimetz, D. (2019). Expediting drug development: FDA’s new regenerative medicine advanced therapy designation. Therapeutic Innovation & Regulatory Science, 53(3), 364-373. doi: 10.1177/2168479018779373

 
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Replies 19460301

/in /by

1-AG 

                                                    Process and Regulations of Fast Track

    New pharmacological agents go a long way in clinical trials and approvals from the Food and Drug Administration before entering a wide market and becoming available to needy patients in the United States. At the same time, for promising drugs that can significantly improve the results of existing therapy or fill a missing niche, this process can be accelerated using the Fast Track protocol (Woo & Robinson, 2015). The latter provides for the filing of a special application by a pharmacological company at the FDA office, which the latter examine within 60 days. If the medicine acquires Fast Track status, manufacturers receive a number of concessions, such as the right to more frequent correspondence and meetings with representatives of this state regulatory body and the possibility of cooperation in conducting a clinical trial. If convincing positive results are obtained, it is possible to obtain FDA approval after a single phase 2 clinical trial (Papadimitriou & Butler, 2017). In addition, the verification process of such a pharmacological agent is significantly reduced from 10 to 6 months.

                                                                    Medical Conditions

    In order to be able to obtain faster approval via the Fast Track protocol, the drug agent must meet a number of requirements. Specific medical conditions are not indicated, but it is prescribed that the effect of the drug should be aimed at treating a life-threatening or dangerous disease, such as heart failure (Papadimitriou & Butler, 2017). A prerequisite is either to improve the outcome of existing treatment, such as a reduction in mortality or disability, or a significant reduction in the toxicity of therapy (Woo & Robinson, 2015). In addition, medical conditions that do not have developed a pharmacological treatment, such as some rare and orphan diseases, are also eligible for faster approval from the FDA via the Fast Track protocol. Therefore, due to this possibility, patients will more quickly gain access to the most modern therapy and increase the chances of a more favorable outcome of treatment.                                                   

                                                                           References

Papadimitriou, L., & Butler, J. (2017). “Fast Track” Development and Approval Process for Heart Failure Therapeutics. Clinical Pharmacology & Therapeutics, 102(2), 184-186.

Woo, T. M., & Robinson, M. V. (2015). Pharmacotherapeutics for advanced practice nurse prescribers. FA Davis.

2-MV

The FDA made it possible for critically needed medications to be introduced to the US market promptly using the “Fast Track” procedure.  “Fast Track” is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need (Vaggelas & Seimetz, 2019).  With fast track, FDA is required by the statute to decide within 60 days of receipt of the request whether the conditions for fast track designation have been met (Vaggelas & Seimetz, 2019).  To be eligible for the fast track program, an applicant must submit a request with supporting documentation for fast track designation for the product and its proposed use (Darrow, Avorn, & Kesselheim, 2018).

The medical conditions that warrant “Fast Track” drugs are serious or life-threatening conditions and those conditions that result in unmet medical needs (Darrow et al., 2018).  Determining whether a condition is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one.  Stroke, epilepsy, brain disorders, depression, AIDS, Alzheimer’s, heart failure, diabetes, and cancer are examples of serious conditions.  Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy (Darrow et al., 2018).

References

Darrow, J. J., Avorn, J., & Kesselheim, A. S. (2018). The FDA breakthrough-drug designation-four years of experience. N Engl J Med, 378(15), 1444-1453.

Vaggelas, A., & Seimetz, D. (2019). Expediting drug development: FDA’s new regenerative medicine advanced therapy designation. Therapeutic Innovation & Regulatory Science, 53(3), 364-373. doi: 10.1177/2168479018779373

 
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Renal Case Study

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Renal Case Study

 

Tea-Colored Urine 

  

Case Scenario:

       Carmelita Gomez, age 8, is brought to the Children’s Clinic by her mother because she is nauseated and has vomited three times in the past 24 hours. Her urine has turned “tea colored”. Carmelita is lethargic and she is complaining of diffuse abdominal pain. Ten days ago she had a sore throat and fever and stayed home from school for two days. She was not seen by a health care provider at that time. Upon questioning, Carmelita cannot remember needing to urinate in the past 12 hours. On exam, Carmelita is irritable and listless. She has slight periorbital edema. Carmelita has active bowel sounds with no palpable abdominal masses, but she is tender in all four quadrants. Carmelita is given a presumptive diagnosis of poststreptococcal glomerulonephritis (PSGN), pending laboratory tests.

Her laboratory values are:

Serum creatinine: 2.3 mg/dL

BUN 26.1 mg/dL

Serum sodium: 142 mEq/L

Potassium 4.2mEq

Specific gravity 1.025

Phosphorous: 6.3 mEq/dL

Calcium: 7 mEq/dL

UA: hematuria 4+, red cell casts

Antistreptococcal antibody titre: 800U

POINTS TO PONDER:

  1. Which lab values are abnormal?
  2. What clinical manifestations      correspond to the abnormal values?
  3. Describe the changes      (pathophysiology) in the body causing each abnormal value and link the      value to a clinical manifestation present in the patient?
  4. Which values are within normal      limits?
  5. What nursing care needs to be      implemented?
  6. Provide one nursing      diagnosis appropriate to this patient.

Reading 

  1. Urinalysis p.1146 (Leeuwen, pg.      546-552)
  2. Culture p.230
  3. Kidney      stone analysis p.696 (Leeuwen, pg. 61,265,426,444)

   

Case    Study Rubric

 

Criteria

 

Abnormal Values

What do the labs indicate specific to   this patient

 

values and signs and   symptoms

The relationship between the abnormal   Signs & Symptoms and lab values is clearly demonstrated. **Must be   specific**

 

Pathophysiology used to demonstrate connections between lab results, manifestations and disease process.

 

Expected care to be given for exhibited   s/s and lab values. Expected correction of lab values based on care given.   Patient education to prevent recurrence of abnormal lab values.

 

Quality

Grammar, spelling, APA…

   

 
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Renal Calculi

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Chapter 41

A patient is admitted with renal calculi.

a.            What symptoms will the patient manifest if he is experiencing renal colic?

b.            How will the nurse best manage the renal colic?

c.             The nurse is straining the urine for presence of stones that the patient may have passed. What is the importance of this nursing action?

 
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Relying On Data 19454655

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Tasks

  • In order for data to be reliable there are several conditions that need to be met—accurate, timely, and complete. Share an example of when you had to make a decision using data that were not accurate, timely, or complete.
 
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Reply Db 2 Apa Reference

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 Reply amanda

Question #2

       There are so many health indicators and concerns for a teen or woman who is a victim of sexual exploitation.  “In a systematic review of the impact of IPV on sexual health, IPV was consistently associated with sexual risk taking, inconsistent condom use, partner non-monogamy, unplanned pregnancies, induced abortions, sexually transmitted infections and sexual dysfunction”(Chamberlin & Levenson, 2011)  These are just some of the physical health concerns they may have.  There are so many emotional concerns that would be linked to sexual exploitation also.   Post-traumatic stress disorder (PTSD), including flashbacks, nightmares, severe anxiety, and uncontrollable thoughts, Depression, including prolonged sadness, feelings of hopelessness, unexplained crying, weight loss or gain, loss of energy or interest in activities previously enjoyed”(Joyful Heart Foundation, 2019). 

      Georgia specifically has a state wide domestic violence hotline. “Educational videos on temporary protective orders were distributed to Nurse Mangers in all 159 Georgia Counties and 19 Health Districts to utilize in trainings and seminars.  The tapes, obtained from the Georgia Commission on Family Violence, were designed to increase the nurses’ knowledge of services available to victims of domestic and sexual assault, and to enable them to direct these women to alternatives that can help reduce their exposure to violence.  Designed and developed a tri-fold pocket card (in English (Links to an external site.)Links to an external site. and Spanish (Links to an external site.)Links to an external site.), in collaboration with the Georgia Coalition Against Domestic Violence (GCADV),  that contains information on the signs of domestic violence, safety plans, options available to survivors of domestic violence, and a list community organizations that work with survivors of domestic violence”(DPH, 2018).

      In my county specifically I know there is an organization called Community Welcome House, Inc.  This organization helps domestic violence victims.  It provides, “Emergency housing sanctuary in the time of crisis Residents receive assistance with medical care, child care, counseling, financial assistance, vocational training, employment and permanent housing”(Domesticshelters.org, 2019). 

Chamberlin, Linda & Levenson, Rebecca. (2011). Guidelines for Addressing Intimate Partner Violence Reproductive and Sexual Coercion For Obstetric, Gynecologic, Reproductive Health Care Settings. American College of Obstetrics and Gynecology. Retrieved on March 17, 2019 from https://www.acog.org/-/media/Departments/Violence-Against-Women/Guidelines-for-Addressing-Intimate-Partner-Violence.pdf?dmc=1&ts=20190317T1155502488

Joyful Heart Foundation. (2019). Effects of Sexual Assault and Rape.  Retrieved on March 17, 2019 from http://www.joyfulheartfoundation.org/learn/sexual-assault-rape/effects-sexual-assault-and-rape

Department of Public Health. (2018). Violence against Women Prevention. Retrieved on March 17, 2019 from https://dph.georgia.gov/violence-against-women-prevention

Domestic Shelters, (2019). Retrieved on March 17, 2019 from https://www.domesticshelters.org/help/ga/newnan/30263/community-welcome-house

 Reply hollie 

Question 1—Domestic Violence

 Domestic violence can come in many shapes and forms. In some cases, physical injury can occur, while in other cases psychological abuse, deprivation, intimidation or other types of harm can occur (ACOG, 2012). The American College of Obstetricians and Gynecologists (ACOG) recognizes that routine visits and prenatal visits are an ideal time to assess for domestic violence (ACOG, 2012). Assessing for domestic violence can be done by using simple screening questions. These questions should not be asked in front of the abuser or other individuals. ACOG (2012) recommends using a framing statement and confidentiality statement before asking any questions. The framing statement lets the patient know that questions are being asked because relationships play a large role in health and the confidentiality statement lets the patient know that what she states today will not be told to anyone else unless reporting is required (ACOG, 2012).  

Risk Factors

 Two risk factors for domestic violence include: low education levels and drug and/or alcohol abuse (Huecker & Smock, 2018). Studies have shown that there is an inverse relationship between education levels and rates of domestic violence (Huecker & Smock, 2018). Men are more likely to perpetrate violence if they have low education and women are more likely to experience intimate partner violence (IPV) if they have a low education level (WHO, 2017). Alcohol and drug use are also risk factors for IPV. Alcohol and drug abuse is associated with an increase in the incidence of domestic violence, likely due to the inability of an impaired person to control violent impulses (Huecker & Smock, 2018).

Clinical Signs

 Obtaining a history, screening for IPV, and performing a physical exam can help point to IPV. Huecker and Smock (2018) state the most common injuries involved in IPV are on the head, neck, and face. Defensive injuries may also be present on the forearms (Huecker & Smock, 2018). A full physical exam should also evaluate the skin in areas covered by clothing (Huecker & Smock, 2018). Sexual abuse may be harder to identify physically, depending on the nature of the abuse (Huecker & Smock, 2018). Psychological complaints may include: anxiety, depression, and fatigue (Huecker & Smock, 2018). The patient may also have vague complaints, such as chronic pain, headaches, or chest pain (Huecker & Smock, 2018).

References

ACOG. (2012). Intimate Partner Violence. The American College of Obstetricians and Gynecologists, 518(1), 1-6. Retrieved from https://www.acog.org/-/media/Committee-Opinions/Committee-on-Health-Care-for-Underserved-Women/co518.pdf?dmc=1&ts=20190318T0127216097

Huecker, M., & Smock, W. (2018). Domestic violence. Treasure Island, FL: StatPearls Publishing. Retrieved from https://www.ncbi.nlm.nih.gov/books/NBK499891/

WHO. (2017). Violence against women. Retrieved from https://www.who.int/news-room/fact-sheets/detail/violence-against-women

 
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Reply Db 1

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Discussion # 1 Advanced Primary Care of Family

    Shared decision-making leads to better health knowledge among the elderly, children, and veterans. They leave the decision-making to caregivers and practitioners. For children and the elderly, they do not participate in their examination, diagnosis, and treatment options because of their limited literacy. The same impacts how this population responds to the management of chronic illnesses and other aspects of care (Seo et al., 2016). Shared-decision making provides the elderly with an opportunity to ask questions when needed, seek more information about their condition, and communicate their health needs. Through this process, older adults gain an understanding of their health and become experts in the decision-making process.

     Today, best practices of models of care such as patient-centered care enhance communication between practitioners and patients. For instance, allowing a patient to be at the forefront of the medical process is an incentive for self-management (Narva, Norton, & Boulware, 2016). The elderly are particularly vulnerable to illiteracy and will tend to research more when they are perceived as decision-makers. They will be keen on the medical process and gain knowledge as a result. Additionally, motivational interviewing ensures that children and older adults are influential in the decision-making process.

     It breaks the barrier of uncertainty and facilitates curiosity among the elderly, who then learn to decode instructions, and risk asking questions about various aspects of their care (LeDoux & Mann, 2019). It is a strategy that promotes autonomy during the care process, which enhances learning.

References

LeDoux, J., & Mann, C. (2019).Addressing Limitations in Health Literacy: Greater Understanding Promotes Autonomy and Self-Determination. Professional case management, 24(4), 219-221.

Narva, A. S., Norton, J. M., & Boulware, L. E. (2016). Educating patients about CKD: the path to self-management and patient-centered care. Clinical Journal of the American Society of Nephrology, 11(4), 694-703.

Seo, J., Goodman, M. S., Politi, M., Blanchard, M., & Kaphingst, K. A. (2016). Effect of health literacy on decision-making preferences among medically underserved patients. Medical Decision Making, 36(4), 550-556.

 
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Reply To Cathy

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Differential Diagnosis for Cough

            A differential diagnosis for chronic cough is gastroesophageal reflux disease (GERD). This is one of the most common causes of chronic cough in patients. Many respiratory organizations worldwide recommend the evaluation and treatment of GERD for the management of chronic cough (Kakhrilas, Smith, & Dicpinigaitis, 2014).

Presenting Symptoms

 Patients normally present with heartburn, dysphagia, acid regurgitation, and an association of cough with a slouched posture. Reflux events that may trigger coughing are microaspiration of refluxate into the airways, extension of reflux into the larynx and pharynx (laryngopharyngeal reflux), or esophageal bronchial reflux (Kakhrilas, Smith & Dicpinigaitis, 2014).

Diagnostic Testing

            A diagnostic test to confirm the diagnosis is an initial therapeutic trial of double-strength proton pump inhibitors (PPIs) for 8 weeks: This may require 8 weeks of double strength PPI therapy for alleviation of symptoms. This trial should not be stopped before 8 weeks and could take up to 3 months. Another test to consider is a 24-hour esophageal pH monitoring with a pH<4 that coincides with the chronic cough and is consistent with pathologic acid exposure. (Epocrates, 2019).

Treatments

            Standard treatments for the cough associated with GERD are proton pump inhibitor for 8 weeks initially and can become an ongoing therapy. In addition, patients with GERD may benefit by avoiding alcohol, caffeine, nicotine, citrus, tomatoes, chocolate, and fatty foods (Domino, 2019).

References

Domino, F., Baldor, R. A., & Golding, J. (2019). The 5-minute clinical consult. (27th

Ed.). [Mobile application software.] Retrieved from http://itunes.apple.com (Links to an external site.)Links to an external site.

Epocrates. (2019). Epocrates plus. (Version 18.11). [Mobile application software].

Retrieved from http://itunes.apple.com (Links to an external site.)Links to an external site.

Kahrilas, P. J., Smith, J. A., & Dicpinigaitis, P. V. (2014). A causal relationship between

cough and gastro esophageal reflux disease (GERD) has been established: A Pro/Con debate. Lung, 192(1),

39-46. doi:http://dx.doi.org/10.1007/s00408-013-9528-7

 
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Reply To Cathy Need 2 Current Apa Citations

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This patient is most likely to have plaque psoriasis, the most common form of psoriasis in young adults, with the average age of onset in the early twenties (Dunphy, Winland-Brown, Porter, & Thomas, 2015).)

            The risk factors for the development of psoriasis are family history. One-third of all patients with psoriasis have a relative with the disease, as in the case study above. When a parent is affected the children have a tendency for an early onset of the condition. Not only that but when both parents are affected the chance increases to forty-one percent of the children having the condition. This patient had an upper respiratory infection prior to the outbreak of the rash; this predisposes her for an outbreak of psoriasis. Even though there is a genetic disposition of the offspring of the parents having the disease, the exact genetic cause is unknown. Research is ongoing regarding the genetic and environmental influences on the cellular effects of the disease (Dunphy, Winland-Brown, Porter, & Thomas, 2015).

          The diagnostic tests to order for this patient are a CBC with differential and serum chemistry profile, serum uric acid level, antinuclear antibody titer, and rheumatoid factor. The serum uric acid level may be elevated. Diagnostic procedures are the Psoriasis Area and Severity Index, which evaluates overall severity and BSA involvement, and the Dermatology Life Quality Index. The top three differentials are seborrheic dermatitis, nummular eczema, and atopic dermatitis (Dominic, Bolder, & Golding, 2019)

            The goal of treatment for the condition of Psoriasis is to identify and avoid triggers. If the condition is mild to moderate keeping the skin hydrated with petrolatum ointments is helpful. Topical corticosteroids are also helpful initially in treating the disease and preventing skin atrophy. In the adult, initial therapy should be corticosteroids with varying potencies. These treatments should not be used longer than 4 weeks (Hendriks… et al, 2013).

            Follow-ups should be done to measure the body surface area involvement and to see if the therapy is working. If the therapy is not working alternative treatments should be prescribed or the addition of another agent to treat the condition should be done. If the psoriasis is greater than twenty percent of the body surface area, or severe extremity involvement especially of the hands and feet develops, a referral is needed (Menter, Gottlieb, Feldman, Van Voorhees, Leonardi, Gordon, et al…2008).

References

Domino, F., Baldor, R. A., & Golding, J. (2019). The 5-minute clinical consult. (27th

Ed.). [Mobile application software.] Retrieved from http://itunes.apple.com

Dunphy, L.M., Winland-Brown, J. E., Porter, B. O., & Thomas, D. J. (2015). Primary

care: the art and science of advanced practice nursing. (4th Ed.). Philadelphia, PA. F. A. Davis Company.

Hendriks, A. G., Keijsers, R. R., de Jong, e. M., Seyger, M. M., van de Kerkof, P. C.

(2013). Efficacy and safety of combinations of first-line topical treatments in chronic plaque psoriasis: a systematic literature review. J Eur Acad Dermatol Venereol. 27(8) 931-951. doi:10.1111/jdv.12058

Menter A, Gottlieb A, Feldman SR, Van Voorhees AS, Leonardi CL, Gordon KB,et al.

(2008). Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 58(5):826-50. 

  •  
 
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Reply To Angela

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The World Health Organization (2012) developed a report on preterm birth rates and how to prevent them. Born to Soon: The Global Action Report on Preterm Birth includes rates and information from multiple countries and provides guidance and interventions on how to prevent preterm birth. Preconception and interconception times are critical to reducing preterm birth. Per WHO (2012, p 45-57) adolescents is a time that pre and interconception care be introduced, not only with intervention that helps to maintain health and nutrition, but to prevent pregnancy in adolescents.

Prevention of intimate partner violence, providing adequate mental health resources, maintaining chronic health conditions, reducing STI transmission and adequate treatment, reducing obesity, and stopping smoking, alcohol intake or elicit drugs are the other items that can increase preterm birth. Assessing for these should be done in the pre and interconception period to help ensure that a future pregnancy will not have complications (WHO, 2012. p 45-57).

Active family planning in relation to what the women’s goals are should be done as well. Having a woman make a cognizant decision or discussing family planning with women at their healthcare visits will make the issue of conception and health more accessible. WHO (2012, p 49) discussed optimal spacing of pregnancies. This would help to reduce physical and emotional stress that could cause preterm birth. Per WHO (2012, p 49) the optimal spacing between births is 18-24 months.

References
World Health Organization. (2012). Born to Soon: The Global Action Report on Preterm Birth. Retrieved from https://www.who.int/pmnch/media/news/2012/201204_borntoosoon-report.pdf 

 
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