Drug Quality and Security Act
Description
Prior to 2012, compounding pharmacies were not required by law to
follow current good manufacturing practices. Then, in October 2012 there
was an outbreak of fungal meningitis reported. The Center for Disease
Control traced the outbreak to fungal contamination in an injectable
corticosteroid that was compounded by New England Compounding Center.
Doses from the lots found to be contaminated had been shipped to 75
medical facilities in 23 states, and doses had been administered to
about 14,000 patients.
Following this tragedy, the Drug Quality and Security Act was
enacted, a bill that would modify the Federal Food, Drug, and Cosmetic
Act and give more authority to regulate and monitor the manufacturing of
compounded medication.
For this assignment, research the Drug Quality and Security Act, which was signed into law by President Obama in November 2013.
Answer key question such as:
- What are some of the changes that were a result of this Act being signed that effect the compounding industry
- Do you believe this tragedy would have been prevented had this bill already been in place? How?
- How could it prevent an outbreak like that which occurred in 2012 from happening again?
- What drawbacks do you see if any and in what ways could this law be improved?
Conduct online research, and then write a 2-page paper, remembering
to answer the above listed questions. Be sure to also include your
references. You will be scored on your grammar and organization as well,
so be sure and spend time revising before submitting.
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References:
Nursing Standards
Nursing and Midwifery Board of Australia. (2018). Code of conduct for midwives. https://www.nursingmidwiferyboard.gov.au/Codes-Guidelines-Statements/Professional-standards.aspx
Clinical Guidelines
Guideline Adaption Committee. (2016). Clinical practice guidelines and principles of care for people with dementia. NHMRC Partnership Centre for Dealing with Cognitive and Related Function Decline in Older People. https://cdpc.sydney.edu.au/wp-content/uploads/2019/06/CDPC-Dementia-Guidelines_WEB.pdf
Living Guideline
Stroke Foundation. (2022). Australian and New Zealand living clinical guidelines for stroke management – chapter 1 of 8: Pre-hospital care. https://app.magicapp.org/#/guideline/NnV76E
Evidence-based practice
BMJ Best Practice
Goldfarb, S., & Josephson, M. (2020). Cystic fibrosis. BMJ Best Practice. https://bestpractice.bmj.com/
Schub, T., & Cabrera, G. (2018). Bites: Head lice [Evidence-based care sheet]. Cinahl Information Systems. https://www.ebscohost.com
Beyea, S. C., & Slattery, M. J. (2006). Evidence-based practice in nursing: A guide to successful implementation. http://www.hcmarketplace.com/supplemental/3737_browse.pdf
JBI: Evidence summary
Swe, K. K. (2022). Blood glucose levels: Self-monitoring [Evidence summary]. JBI EBP Database. https://jbi.global
JBI: Best practice information sheet
Bellman, S. (2022). Experiences of living with juvenile idiopathic arthritis [Best practice information sheet]. JBI EBP Database, 24(1), 1-4.
Cochrane Database of Systematic Reviews
Srijithesh, P. R., Aghoram, R., Goel, A., & Dhanya, J. (2019). Positional therapy for obstructive sleep apnoea. Cochrane Database of Systematic Reviews. https://doi.org/10.1002/14651858.CD010990.pub2
Drug Information
Codeine. (2023, January). In Australian medicines handbook. Retrieved February 2, 2023, from https://amhonline.amh.net.au
Colorado State University. (2011). Why assign WID tasks? http://wac.colostate.edu/intro/com6a1.cfm
Dartmouth Writing Program. (2005). Writing in the social sciences. http://www.dartmouth.edu/~writing/materials/student/soc_sciences/write.shtml
Rutherford, M. (2008). Standardized nursing language: What does it mean for nursing practice? [Abstract]. Online Journal of Issues in Nursing, 13(1). http://ojin.nursingworld.org/MainMenuCategories/ThePracticeofProfessionalNursing/Health-IT/StandardizedNursingLanguage.html
Wagner, D. (n.d.). Why writing matters in nursing. https://www.svsu.edu/nursing/programs/bsn/programrequirements/whywritingmatters/
Writing in nursing: Examples. (n.d.). http://www.technorhetoric.net/7.2/sectionone/inman/examples.html
Perth Children’s Hospital. (2022, April). Appendicitis [Emergency Department Guidelines]. Child and Adolescent Health Service. https://www.pch.health.wa.gov.au/For-health-professionals/Emergency-Department-Guidelines/Appendicitis
Department of Health. (n.d.). Who is being active in Western Australia? https://ww2.health.wa.gov.au/Articles/U_Z/Who-is-being-active-in-Western-Australia
Donaldson, L. (Ed.). (2017, May 1). Healthier, fairer, safer: The global health journey 2007-2017. World Health Organisation. https://www.who.int/publications/i/item/9789241512367
NCBI Bookshelf
Rodriguez Ziccardi, M., Goyal, G., & Maani, C. V. (2020, August 10). Atrial flutter. In Statpearls. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK540985/
Royal Perth Hospital. (2016). Procedural management: Pre and post (24-48 hours) NPS. Canvas. https://courses.ecu.edu.au
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