Advanced pharmacology week 11 response 1
Title Advanced pharmacology week 11 response 1
Prefered Language style English (U.S.)
Type of document Essay
Number of pages/words 1 Page Double Spaced (approx 275 words per page)
Subject area Pharmacology
Academic Level Master
Style APA
Number of sources/references 3
Order description:
Please respond to Barnabys post by who provided a different rationale than you did, in one or more of the following ways:
Offer and support an alternative perspective using readings from the classroom or from your own research in the Walden Library.
Validate an idea with your own experience and additional research. and use the readings for at least 2 of the references
Learning Resources
This page contains the Learning Resources for this week.
Required Readings
Arcangelo, V. P., Peterson, A. M., Wilbur, V., & Reinhold, J. A. (Eds.). (2017). Pharmacotherapeutics for advanced practice: A practical approach (4th ed.). Ambler, PA: Lippincott Williams & Wilkins.
Review Chapter 4, “Principles of Pharmacotherapy in Pediatrics” (pp. 53-63)
This chapter explores concepts relating to drug selection, administration, and interaction for pediatric patients. It also compares age-related pharmacokinetic differences in children and adults.
Chapter 17, “Ophthalmic Disorders” (pp. 221-243)
This chapter examines the causes, pathophysiology, diagnostic criteria, and drug treatment for four ophthalmic disorders: blepharitis, conjunctivitis, keratoconjunctivitis sicca, and glaucoma. It also explores methods of monitoring patient response to treatment.
Chapter 43, “Attention-Deficit/Hyperactivity Disorder” (pp. 743-756)
This chapter explains the process of diagnosing Attention-Deficit/Hyperactivity Disorder (ADHD). It also identifies drugs for treating patients with ADHD, including proper dosages, selected adverse events, and special considerations for each drug.
Chapter 51, “Immunizations” (pp. 906-926)
This chapter explores vaccines that are licensed for use in the United States and provides a recommended vaccination schedule for pediatric patients and adults.
Chapter 52, “Smoking Cessation” (pp. 927-943)
This chapter examines clinical implications of smoking. It also covers various approaches for aiding patients who are dependent on nicotine but want to stop smoking.
Chapter 54, “Weight Loss” (pp. 945-956)
This chapter begins by reviewing patient factors that contribute to obesity. It also examines drug therapy for initiating weight loss in patients, as well as alternative non-drug treatments.
Bazzano, A. T, Mangione-Smith, R., Schonlau, M., Suttorp, M. J., & Brook, R. H. (2009). Off-label prescribing to children in the United States outpatient setting. Academic Pediatrics, 9(2), 81–88.
Note: Retrieved from the Walden Library databases.
This study examines the frequency of off-label prescribing to children and explores factors that impact off-label prescribing.
Mayhew, M. (2009). Off-label prescribing. The Journal for Nurse Practitioners, 5(2), 122–123.
Note: Retrieved from the Walden Library databases.
This article reviews the prevalence of off-label prescribing, including its benefits and risks. It also explores issues regarding the safety of off-label prescribing and when it is unavoidable.
Drugs.com. (2012). Retrieved from http://www.drugs.com/
This website presents a comprehensive review of prescription and over-the-counter drugs including information on common uses and potential side effects. It also provides updates relating to new drugs on the market, support from health professionals, and a drug-drug interactions checker.
Required Media
Laureate Education, Inc. (Executive Producer). (2012). Advanced pharmacology – Final course review. Baltimore, MD: Author
Barnabys post
18 hours ago Barnaby Urias
DQ 11- Off-Label Drug Use in Pediatrics
COLLAPSE
Professor and Class,
When treating pediatric patients, many health care practitioners use the terms, infant, child, or even kid, interchangeably. Several barriers exist for pharmaceutical manufacturers in conducting pediatric clinical trials, such as fears of unforeseen adverse events affecting growth and development or difficulties in obtaining informed consent or blood samples. In turn, the lack of clinical trials in pediatric patients prevents the U.S. Food and Drug Administration (FDA) from approving drugs for use in the pediatric population. Without FDA approval or adequate documentation information, many practitioners are uncertain how to use drugs in pediatrics. This leaves practitioners little choice but to use drugs in pediatric patients in an off-label capacity, based on adult data, uncontrolled pediatric studies, or personal experience (Arcangelo, 2017).
Off Label Usage
Some variables that may explain off-label prescribing, such as physician and family attitudes, previously used medications, and the context of the visit, are not included in National Ambulatory Medical Care Surveys (NAMCS) (Bazzano, 2009).
The prescription of off-label medication is commonplace since more beneficial treatments for children are often not available, while trials for many medicines intended for children have in fact not been carried out. The most common reasons given by respondents for a dispensed prescription being off label were younger age than recommended. The majority of respondents were not familiar with the concept of off label medicines. While reporting to have gained their knowledge from their professional experience, only a minority of respondents reported knowingly dispensing off-label medicines for pediatric patients. Respondents indicated that manufacturing more appropriate formulations for pediatric patients would reduce such practices in this population. Having concerns regarding the efficacy and safety of off-label medicines used for pediatric patients, respondents felt that the use of off-label medicines would increase the likelihood of adverse drug reactions (ADRs). Finally, respondents felt that such practice of prescribing and dispensing should receive parental consent (Tareq, 2018).
Infancy to Adolescence
Pediatric patients differ from adults, anatomically and physiologically. For safe use of drugs in pediatrics, prescribers and other caregivers need to recognize the potential for very different pharmacokinetics in pediatric patients as opposed to adults. The differences are based on developing body tissues and organs, which affect a drug’s absorption, distribution, metabolism, and excretion. Changes in a pediatric patient’s body proportions and composition and the relative size of the liver and kidneys can alter the pharmacokinetics of a drug. During the first of the several years of life, a child undergoes rapid changes in growth and development, most rapid during infancy. Growth is qualitative change in skills or functions. Maturation, genetically controlled development independent of the environment, is a slower process, lasting until late childhood (Arcangelo, 2017).
Off-label prescribing is more frequent for younger children and those receiving care from specialist pediatricians. Increased dissemination of pediatric studies and label information may be helpful to guide clinical practice. Further research should be prioritized for the medications most commonly prescribed off label and to determine outcomes, causes, and appropriateness of off-label prescribing to children (Bazzano, 2009).
There are some positive aspects to off-label prescribing. Prescribing a drug off-label may be necessary when no FDA-approved drug is available due to lack of research. Pediatrics is an area where there is a dearth of adequate studies, necessitating off-label prescribing (Mayhew, 2009).
Medications
Rofecoxib (Vioxx) is cited as an example of a drug whose adverse effects became apparent only after considerable use and testing. Off-label prescribing may allow drug manufacturers to circumvent the research they might conduct on a drug. The off-label use of new, expensive drugs instead of older generic medications can increase health care costs (Mayhew, 2009).
Vioxx was withdrawn from the U.S. market in 2004. The manufacturer of Vioxx has announced a voluntary withdrawal of the drug from the U.S. and worldwide market. This withdrawal is due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients taking Vioxx. General side effects have included asthenia, fatigue, dizziness, influenza-like disease, lower extremity edema, sinusitis and upper respiratory infection. Other general side effects have included abscess, chest pain, chills, contusion, cyst, diaphragmatic hernia, fever, fluid retention, flushing, fungal infection, infection, laceration, pain, pelvic pain, peripheral edema, postoperative pain, syncope, trauma, upper extremity edema, viral syndrome, cerumen impaction, epistaxis, dry throat, otic pain, otitis, otitis media, pharyngitis, tinnitus, and tonsillitis (Drugs, 2012).
Reference
Arcangelo, V. P., Peterson, A. M., Wilbur, V., & Reinhold, J. A. (Eds.). (2017). Pharmacotherapeutics for advanced practice: A practical approach (4th ed.). Ambler, PA: Lippincott Williams & Wilkins
Bazzano, A. T, Mangione-Smith, R., Schonlau, M., Suttorp, M. J., & Brook, R. H. (2009). Off-label prescribing to children in the United States outpatient setting. Academic Pediatrics, 9(2), 81–88
Mayhew, M. (2009). Off-label prescribing. The Journal for Nurse Practitioners, 5(2), 122–123
Drugs.com. (2012). Retrieved from http://www.drugs.com/
Tareq L., M., Karem H., A., Amani M., A., Anan S., J., Rana K. Abu, F., Mohammad B., N., & James C., M. (2018). Perceptions and attitudes towards off-label dispensing for pediatric patients, a study of hospital based pharmacists in Jordan. Saudi
