Case Study-Four Pages-Experimental Drug Approval Or Denied

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Four pages not including cover page or references

Recent studies support the potential of a drug that is derived from the metal iridium to effectively treat cancer. This experimental drug, Drug ZL105, has not been tested for efficacy and toxicity. Imagine that you are the one responsible for approving or denying the use of this drug within the United States. Your job is to propose the testing that is needed for this drug to be determined as safe and effective for the treatment of cancer in humans. In your research and discussion, you should address the questions below.

What model(s) will you use for testing (i.e., animal, cell cultures, computer simulations)? Explain the choice of model, and provide support for the reliability of the model. Discuss the pros and cons of your choice.

In determining the safety and effectiveness of the drug, would it be necessary to test efficacy, toxicity, and lethality?

Explain what each of these tests are for and whether or not one or more of the tests are necessary for your determination.

Provide your thoughts on what information you hope to gather from your tests and whether or not the same protocol should be used for various categories of products such as drugs, cosmetics, and herbal medicines.

Your case study assignment should be four pages in length and utilize at least four reliable references. Use APA style guidelines in writing this assignment, following APA rules for formatting, quoting, paraphrasing, citing, and referencing.

Information about accessing the grading rubric for this assignment is provided below.

PDR DRUG CARD

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For this assignment you will complete research and use the Physician’s Desk Reference (PDR) website. The Physician’s Desk Reference or PDR is a collection of manufacturers’ prescribing information on prescribed drugs. It is updated annually and designed to help allied health professionals to research drug information.

Using the Physician’s Desk Reference website, http://www.pdr.net/, you will identify a total of 10 drugs. You will complete 10 drug cards. Pick one drug from each of the categories of the Top 200 Drugs:

  • Gastrointestinal
  • Musculoskeletal
  • Respiratory
  • Immune
  • Neuro
  • Cardio
  • Endocrine
  • Eye drops
  • Vitamin, Mineral, Electrolyte
  • one from one of the disorders you learned about in the units

Download the attached template to fill in your answers. The template has the 10 required cards.

For each drug, identify the following:

  • Drug Brand Name
  • Other Brand Names/Generic Names (If not listed leave blank)
  • Manufacturer (Located by the name of the drug – might be listed as Names of Individuals, Inc., company)
  • Therapeutic Class
  • Indications
  • Adult Dosage/ Pediatric Dosage
  • How Supplied (Tabs, injection, topical, sublingual, IV, etc. scored or not scored)
  • Contraindications
  • Warnings/Precautions
  • Adverse Reactions
  • Drug Interactions
  • Pregnancy/Category
  • Assessment/Monitoring
  • Patient Counseling
  • Administration/Storage

It is important to practice the pronunciation of medical terms including the names of medications. Please visit one of the following links, and for each of the drugs you chose for this assignment, enter the name of the drug within the search box, then click to listen to the correct pronunciation. http://www.merriam-webster.com/dictionary/ or http://www.merriam-webster.com/medlineplus/ 

PDR Drug Card Gastrointestinal

Drug Brand Name

[answer here]

Other Brand Names/Generic Names

[answer here]

Manufacturer

[answer here]

Therapeutic Class

[answer here]

Indications

[answer here]

Adult Dosage/ Pediatric Dosage

[answer here]

How Supplied (Tabs, injection, topical, sublingual, IV, etc. scored or not scored)

[answer here]

Contraindications

[answer here]

Warnings/Precautions

[answer here]

Adverse Reactions

[answer here]

Drug Interactions

[answer here]

Pregnancy/Category

[answer here]

Assessment/Monitoring

[answer here]

Patient Counseling

[answer here]

Administration/Storage

[answer here]

 

 

 

 

PDR Drug Card Musculoskeletal

Drug Brand Name

[answer here]

Other Brand Names/Generic Names

[answer here]

Manufacturer

[answer here]

Therapeutic Class

[answer here]

Indications

[answer here]

Adult Dosage/ Pediatric Dosage

[answer here]

How Supplied (Tabs, injection, topical, sublingual, IV, etc. scored or not scored)

[answer here]

Contraindications

[answer here]

Warnings/Precautions

[answer here]

Adverse Reactions

[answer here]

Drug Interactions

[answer here]

Pregnancy/Category

[answer here]

Assessment/Monitoring

[answer here]

Patient Counseling

[answer here]

Administration/Storage

[answer here]

 

 

 

PDR Drug Card Respiratory

Drug Brand Name

[answer here]

Other Brand Names/Generic Names

[answer here]

Manufacturer

[answer here]

Therapeutic Class

[answer here]

Indications

[answer here]

Adult Dosage/ Pediatric Dosage

[answer here]

How Supplied (Tabs, injection, topical, sublingual, IV, etc. scored or not scored)

[answer here]

Contraindications

[answer here]

Warnings/Precautions

[answer here]

Adverse Reactions

[answer here]

Drug Interactions

[answer here]

Pregnancy/Category

[answer here]

Assessment/Monitoring

[answer here]

Patient Counseling

[answer here]

Administration/Storage

[answer here]

 

 

 

 

PDR Drug Card Immune

Drug Brand Name

[answer here]

Other Brand Names/Generic Names

[answer here]

Manufacturer

[answer here]

Therapeutic Class

[answer here]

Indications

[answer here]

Adult Dosage/ Pediatric Dosage

[answer here]

How Supplied (Tabs, injection, topical, sublingual, IV, etc. scored or not scored)

[answer here]

Contraindications

[answer here]

Warnings/Precautions

[answer here]

Adverse Reactions

[answer here]

Drug Interactions

[answer here]

Pregnancy/Category

[answer here]

Assessment/Monitoring

[answer here]

Patient Counseling

[answer here]

Administration/Storage

[answer here]

 

 

 

PDR Drug Card Neuro

Drug Brand Name

[answer here]

Other Brand Names/Generic Names

[answer here]

Manufacturer

[answer here]

Therapeutic Class

[answer here]

Indications

[answer here]

Adult Dosage/ Pediatric Dosage

[answer here]

How Supplied (Tabs, injection, topical, sublingual, IV, etc. scored or not scored)

[answer here]

Contraindications

[answer here]

Warnings/Precautions

[answer here]

Adverse Reactions

[answer here]

Drug Interactions

[answer here]

Pregnancy/Category

[answer here]

Assessment/Monitoring

[answer here]

Patient Counseling

[answer here]

Administration/Storage

[answer here]

 

 

 

PDR Drug Card Cardio

Drug Brand Name

[answer here]

Other Brand Names/Generic Names

[answer here]

Manufacturer

[answer here]

Therapeutic Class

[answer here]

Indications

[answer here]

Adult Dosage/ Pediatric Dosage

[answer here]

How Supplied (Tabs, injection, topical, sublingual, IV, etc. scored or not scored)

[answer here]

Contraindications

[answer here]

Warnings/Precautions

[answer here]

Adverse Reactions

[answer here]

Drug Interactions

[answer here]

Pregnancy/Category

[answer here]

Assessment/Monitoring

[answer here]

Patient Counseling

[answer here]

Administration/Storage

[answer here]

 

 

 

PDR Drug Card Endocrine

Drug Brand Name

[answer here]

Other Brand Names/Generic Names

[answer here]

Manufacturer

[answer here]

Therapeutic Class

[answer here]

Indications

[answer here]

Adult Dosage/ Pediatric Dosage

[answer here]

How Supplied (Tabs, injection, topical, sublingual, IV, etc. scored or not scored)

[answer here]

Contraindications

[answer here]

Warnings/Precautions

[answer here]

Adverse Reactions

[answer here]

Drug Interactions

[answer here]

Pregnancy/Category

[answer here]

Assessment/Monitoring

[answer here]

Patient Counseling

[answer here]

Administration/Storage

[answer here]

 

 

 

PDR Drug Card Eye Drops

Drug Brand Name

[answer here]

Other Brand Names/Generic Names

[answer here]

Manufacturer

[answer here]

Therapeutic Class

[answer here]

Indications

[answer here]

Adult Dosage/ Pediatric Dosage

[answer here]

How Supplied (Tabs, injection, topical, sublingual, IV, etc. scored or not scored)

[answer here]

Contraindications

[answer here]

Warnings/Precautions

[answer here]

Adverse Reactions

[answer here]

Drug Interactions

[answer here]

Pregnancy/Category

[answer here]

Assessment/Monitoring

[answer here]

Patient Counseling

[answer here]

Administration/Storage

[answer here]

 

 

 

 

PDR Drug Card Vitamin, Mineral, Electrolyte, etc.

Drug Brand Name

[answer here]

Other Brand Names/Generic Names

[answer here]

Manufacturer

[answer here]

Therapeutic Class

[answer here]

Indications

[answer here]

Adult Dosage/ Pediatric Dosage

[answer here]

How Supplied (Tabs, injection, topical, sublingual, IV, etc. scored or not scored)

[answer here]

Contraindications

[answer here]

Warnings/Precautions

[answer here]

Adverse Reactions

[answer here]

Drug Interactions

[answer here]

Pregnancy/Category

[answer here]

Assessment/Monitoring

[answer here]

Patient Counseling

[answer here]

Administration/Storage

[answer here]

 

 

 

PDR Drug Card One disorders you learned about in the unit material

Drug Brand Name

[answer here]

Other Brand Names/Generic Names

[answer here]

Manufacturer

[answer here]

Therapeutic Class

[answer here]

Indications

[answer here]

Adult Dosage/ Pediatric Dosage

[answer here]

How Supplied (Tabs, injection, topical, sublingual, IV, etc. scored or not scored)

[answer here]

Contraindications

[answer here]

Warnings/Precautions

[answer here]

Adverse Reactions

[answer here]

Drug Interactions

[answer here]

Pregnancy/Category

[answer here]

Assessment/Monitoring

[answer here]

Patient Counseling

[answer here]

Administration/Storage

[answer here]

 

 MO160: Pathophysiology and Pharmacology Page 20

Maternal L&D

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MATERNITY 2 1

 

 

 

 

 

Carla Hernandez is a 32-year-old Hispanic female, G2P1 (L1) at 39 5/7 weeks of gestation. She was admitted to labor and delivery in active labor at 0600 hours today, accompanied by her husband Earl. Her contractions began at 0015 hours, and they have been every 3-5 minutes, lasting 60 seconds, since 0330 hours. Baseline FHR has been steady at 140 bpm with no periodic changes noted. Patient denies any leakage of fluid or vaginal bleeding. Last estimated fetal weight was 2,700 g (6 lb) by ultrasound. Patient states that the baby feels smaller than her first. Her first delivery was an uncomplicated vaginal birth, a male born at 40 2/7 weeks of gestation who weighed 2,785 g (6 lb 2 oz).

An hour ago Carla was 5 cm dilated, 90% effaced, and at a 0 station. Membranes are still intact. She has signed all the admission papers. Lactated Ringer’s is running IV at 125 mL/hr in her left arm.

 

 

 

· 1. Document your initial assessment data for Carla Hernandez. Include the following: uterine activity (frequency, duration, and intensity), fetal heart rate activity (baseline fetal heart rate, long-term variability, accelerations, and decelerations), vaginal discharge, vaginal bleeding, and maternal vital signs.

· 2. Document the medication(s) that you administered.

· 3. Document the situation-background-assessment-recommendation (SBAR) communication to Carla Hernandez’s provider.

· 4. Using SBAR, document the events surrounding the artificial rupture of membranes by Carla Hernandez’s provider. Note the times for the nursing interventions taken during this simulation and evaluate the effectiveness of these measures in resolving the identified problem(s).

· 5. Document the fetal heart rate monitoring and any abnormalities noted during this simulation.

Metric

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Metric Equivalents

Calculate the following:

Proportional Method

Using the proportional method, convert each of the following metric equivalents:

a. 250 ml = _____L

b. 0.5L = _____ ml

c. 2 g = _____ mg

d. 500 mg = _____g

e. 0.0300 g = _____mg

f. 0.05 mg = _____ g

g. 1 mcg = _____ mg

h. 2 ml = _____ cc

i. 1000 g = _____kg

j. 2 kg = _____lb

 

Decimal Method

Using the moving the decimal method, convert each of the following metric equivalents:

a. 60 mg = _____g

b. 0.005 L = _____ ml

c. 200 ml = _____L

d. 1 g = _____kg

e. 0.0065 g = _____mg

f. 3.5 cc = _____L

g. 4 kg = _____ g

h. 1 ml = _____L

i. 0.1 L = _____ ml

j. 0.05 mg = _____g

 

 

Dosages according to kilogram of body weight

Calculate the following dosages according to kilogram of body weight.

 

a. The physician ordered Polymox (amoxicillin) oral suspension 20 mg/kg/day in divided doses every 8 hours for a child who weights 66 pounds. Convert pounds to kilograms and then calculate the prescribed dosage.

______ mg every _____ hours

 

b. The physician ordered Kefzol (cefazolin sodium) IM 25 mg/kg/day in three equal doses every 8 hours for a child who weighs 50 pounds. Convert pounds to kilograms and then calculate the prescribed dosage.

______ mg every _____ hours

 

c. The physician ordered Velosef (cephradine) IM 50 mg/kg/day in equally divided doses four times a day for a child who weighs 40 pounds. Convert pounds to kilograms and then calculate the prescribed dosage.

______ mg every _____ hours

 

d. The physician ordered Tegopen (cloxacillin sodium) oral solution 50 mg/kg in equally divided doses at 6-hour intervals for a child who weighs 23 pounds. Convert pounds to kilograms and then calculate the prescribed dosage.

______ mg every _____ hours

 MO160: Pathophysiology and Pharmacology

 MO160: Pathophysiology and Pharmacology Page 2