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Transcript of Off-Label Medications
FDA Consumer Protection Service Responsible for the approval of medications Stantis, 12/19/2012 What is an "Off-label" Medication? www.stus.com, 12/19/2012 161 controlled trials published, 5 in preschoolers, 150 in school aged children, 7 studies in adolescents, and 9 studies in adults. 1900s The Prescribing of off-label medications for use in children poses a certain level of risk due to the unknown effects; however, it is necessary due to the countless lives saved. Fegert, Schnoor, Koelch More Adults than Children http://thebrandbuilder.wordpress.com/ http://blog.pkids.org/2010/11/15/2407/ http://www.cmionline.com/get-started/k-12/children-at-different-ages-6/ http://www.newarkoym.com/index.cfm?load=page&page=251 Infants Children Adolescents ` Brain Scan 5-20 years Constructed from MRI scans of healthy children and teens
Gray matter wanes in a back-to-front wave as the brain matures and neural connections are pruned. http://www.edinformatics.com/news/teenage_brains.htm "Only half of the medications doctors prescribe to patients 18 and younger have been through the same rigorous trials as those drugs prescribed to adults."
(Safer drugs for kids) http://bipolarbear.co.nz/2012/07/12/a-series-of-unfortunate-side-effects/ "Potent and unique side effects in children and teens that they do not have in adults." "Off-label Drug Use" Ethics Inform the Children Age, Maturity, Intellect, Understanding lawinfo More than 60% of prescriptions in the United States are for off-label medications Examples: - Antibiotics: Viral Infections (common cold, flu)
- Antihistamines (for allergies): Colds, Asthma, Ear Infection, Sleep Aids
- Risperidone (antipsychotic): Alzheimers Disease, Dementia, Eating Disorders
- Anti-seizure drugs: Migraines, Depression, Nerve Pain "Off-label drug prescribing: What does it mean for you?" consumerreports.org "Once a drug has been approved for adults, health care professionals can legally prescribe it for young children." Safe and effective medicines for children Laws: FDA Safety and Innovation Act Pediatric Rule Pediatric Exclusivity Provision Off-label Meds Are Important! "If [the] industry uses [the] money they saved back to research and development, that's a good thing. If they don't, it's not such a good thing." Kane, Off-label Drug Use: Pros and Cons Insurance status, sex, race, population concentration, lower cost Impossible to think that the level of use will decrease! SOURCE: CREATIVE COMMONS / FLICKR / TAX CREDITS Thank you.
Questions? Thesis Statement Should Medical Personnel be allowed to prescribe "off-label" medications to children? Works Cited Costea, G. Oana, Steven Barreto, and Maria L. Burns. "Talking with Children about Medication: From Ethics to Patient Education." Brown University Child and Adolescent Behavior Letter Dec. 2008: n. pag. Print.
Drury, Stacy S., and Mary Margaret Gleason. "A Delicate Brain: Ethical and Practical Considerations for the Use of Medications in Very Young Children." Psychiatric Times 29.3 (2012): 20-22. Abstract. Print.
Fegert, Joerg M., Kathleen Schnoor, and Michael Koelch. Ethical Issues in Psychopharmacology of Children and Adolescents. Pub. N.p.: n.p., n.d. Print. Current Opinion in Psychiatry 21.
Kane, Michael. Off-Label Drug Use: Pros and Cons. Pub. N.p.: n.p., 2012. Print.
"Off-Label Drug Prescribing: What Does It Mean for You?" Consumerreports.org. Consumers Union of U.S., n.d. Web. 1 Dec. 2012. <http://www.consumerreports.org/cro/2012/05/off-label-drug-prescribing-what-does-it-mean-for-you/index.htm>.
"'Off-Label' Drug Use." Consumerreports.org. Consumers Union, n.d. Web. 2 Dec. 2012. <http://www.consumerreports.org/health/resources/pdf/best-buy-drugs/money-saving-guides/english/Off-Label-FINAL.pdf>
Parikh, Rahul K. "Why Doctors Need to Keep the Power to Give Drugs Off-Label." Slate.com. N.p., n.d. Web. 1 Dec. 2012. <http://www.slate.com/articles/health_and_science/medical_examiner/2007/12/help_my_prescription_pen_is_running_out_of_ink.html>.
Pedersen, Traci. "Big Jump in Antipsychotic Drugs Prescribed for Kids." Psychcentral. N.p., n.d. Web. 8 Nov. 2012. <http://psychcentral.com/news/2012/08/15/big-jump-in-antipsychotic-drugs-prescribed-for-kids/43099.html>.
Raven, Melissa, and Peter Parry. "Psychotropic Marketing Practices and Problems: Implications for DSM-5." Journal of Nervous and Mental Disease 200 (2012): 512-16. Print.
Safe and Effective Medicines for Children: Pediatric Studies Conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act (2012). Print.
"Safer Drugs for Kids." Scientific American Sept. 2012: 12. Print.
Steinbrook, Robert. Testing Medications in Children. Health Policy Report. N.p.: n.p., 2002. Print. Red indicates more gray matter, blue indicates less gray matter Federal Food, Drug and Cosmetic Act of 1938 Values of the health care team Wishes of the child's guardian(s) Anti psychotic prescriptions Denied = Small number of choices 1960s to 1970s Aspirin...lowers chance of a second heart attack? Prescribing off-label medications is a risky business yet it seems to be necessary to make patient care effective and efficient. Ethics Rapid Treatment Amount of time Off-Label Use http://www.google.ca/imgres?q=alberta+children%27s+hospital&hl=en&sa=X&tbo=d&noj=1&tbm=isch&tbnid=zOxre0wx5QAPpM:&imgrefurl=http://randomhillary.blogspot.com/2011/11/this-week-i-got-my-1st-canadian-nurse.html&docid=q1-M5p22iMMzzM&imgurl=http://4.bp.blogspot.com/-D-7F34ZqLy8/Tr9OOq2ArdI/AAAAAAAADf0/iWMi6UmrH9E/s1600/Cummins-Alberta%252BHospital-large.jpg&w=468&h=333&ei=z-70UJqeLcj-rAeiooHAAg&zoom=1&iact=rc&dur=475&sig=105525489779968187291&page=1&tbnh=154&tbnw=211&start=0&ndsp=14&ved=1t:429,r:9,s:0,i:123&tx=124&ty=82&biw=1024&bih=540