The Combat Methamphetamine Epidemic Act of 2005 was signed into law by President George W. Bush on March 9, 2006 to regulate over-the-counter sales of pseudoephedrine, ephedrine, and phenylpropanolamine, which are chemicals used to illegally manufacture methamphetamine. The law required pharmacies to keep these medications behind the counter, record sales, and limit monthly purchases. Its goal was to curb the meth epidemic in the United States by controlling access to the drug precursors while still allowing legal access to medicines for consumers.
In this presentation, Director of National Outreach Shabbir Imber Safdar reviews the current state of counterfeit drugs in America today, discusses some of the myths surrounding importation, and provides tips for saving money safely on the cost of prescription drugs.
Emerging drugs of Abuse and Emerging Drug TrendsGlenn Duncan
Last updated on May 14, 2018. Emerging drugs of abuse, including synthetic cannabinoids, synthetic cathinones (MDPV, Alpha-PVP), kratom, hallucinogens, MDMA (Molly), NBOMe, PCP, salvia, DXM, Lean (Purple Drank), Vaping, U-4770, and more. Also covered are emerging trends of existing drugs of abuse such as opiates, cocaine and alcohol.
In this webinar I provide an overview of counterfeits in America, I talk about some myths of importation, and I teach patients and patient advocates some great tips for saving money safely.
Healthcare providers are increasingly breaking the secure supply chain and endangering patients. Learn about counterfeit drugs and most recent incidents involving providers.
Also learn about how you can be a part of the solution by working with the Partnership for Safe Medicines.
In this presentation, Director of National Outreach Shabbir Imber Safdar reviews the current state of counterfeit drugs in America today, discusses some of the myths surrounding importation, and provides tips for saving money safely on the cost of prescription drugs.
Emerging drugs of Abuse and Emerging Drug TrendsGlenn Duncan
Last updated on May 14, 2018. Emerging drugs of abuse, including synthetic cannabinoids, synthetic cathinones (MDPV, Alpha-PVP), kratom, hallucinogens, MDMA (Molly), NBOMe, PCP, salvia, DXM, Lean (Purple Drank), Vaping, U-4770, and more. Also covered are emerging trends of existing drugs of abuse such as opiates, cocaine and alcohol.
In this webinar I provide an overview of counterfeits in America, I talk about some myths of importation, and I teach patients and patient advocates some great tips for saving money safely.
Healthcare providers are increasingly breaking the secure supply chain and endangering patients. Learn about counterfeit drugs and most recent incidents involving providers.
Also learn about how you can be a part of the solution by working with the Partnership for Safe Medicines.
Securing the Global Pharmaceutical Supply Chain against the Threat of Counter...Yasmin AbdelAziz
In 2012, counterfeit versions of the cancer drug
Avastin were found in 19 American treatment
centers. The impostor drug lacked the active
ingredient, rendering it virtually useless for
treatment purposes.
A presentation by J. Aaron Graham, Executive Director of Brand Safety & Security at Boehringer Ingelheim Pharmaceuticals, Inc., about the threat of imported counterfeit prescription drugs.
Understanding Pharmacology for Health Professionals 4th Edition Turley Test BankEmilyVaughanss
Full download : https://alibabadownload.com/product/understanding-pharmacology-for-health-professionals-4th-edition-turley-test-bank/ Understanding Pharmacology for Health Professionals 4th Edition Turley Test Bank , Understanding Pharmacology for Health Professionals,Turley,4th Edition,Test Bank
Counterfeit drugs: what a doctor should knowMark Davison
Short lecture to medical students on risks, prevalence and detection of fake medicines and protection of patient safety. Essential training for new doctors and pharmacists.
The Future of Off-Label Marketing Regulations in a Post Sorrell EraJared Iraggi
How Sorrel v. IMS Health impacted corporate scientific speech right and how this decision will likely be used in efforts to find FDA Labeling Regulations overly burdensome on truthful scientific speech.
Securing the Global Pharmaceutical Supply Chain against the Threat of Counter...Yasmin AbdelAziz
In 2012, counterfeit versions of the cancer drug
Avastin were found in 19 American treatment
centers. The impostor drug lacked the active
ingredient, rendering it virtually useless for
treatment purposes.
A presentation by J. Aaron Graham, Executive Director of Brand Safety & Security at Boehringer Ingelheim Pharmaceuticals, Inc., about the threat of imported counterfeit prescription drugs.
Understanding Pharmacology for Health Professionals 4th Edition Turley Test BankEmilyVaughanss
Full download : https://alibabadownload.com/product/understanding-pharmacology-for-health-professionals-4th-edition-turley-test-bank/ Understanding Pharmacology for Health Professionals 4th Edition Turley Test Bank , Understanding Pharmacology for Health Professionals,Turley,4th Edition,Test Bank
Counterfeit drugs: what a doctor should knowMark Davison
Short lecture to medical students on risks, prevalence and detection of fake medicines and protection of patient safety. Essential training for new doctors and pharmacists.
The Future of Off-Label Marketing Regulations in a Post Sorrell EraJared Iraggi
How Sorrel v. IMS Health impacted corporate scientific speech right and how this decision will likely be used in efforts to find FDA Labeling Regulations overly burdensome on truthful scientific speech.
73What is Special Education 1iStockphotoThinkstock.docxalinainglis
73
What is Special Education? 1
iStockphoto/Thinkstock
Pre-Test
1. You can use the terms disability and handicap interchangeably. T/F
2. The history of special education began in Europe. T/F
3. The first American legislation that protected students with disabilities was passed in the 1950s. T/F
4. All students with disabilities should be educated in special education classrooms. T/F
5. Special education law is constantly reinterpreted. T/F
Answers can be found at the end of the chapter.
4Accreditation, Regulation, and
Agencies of Healthcare Quality
Alex Brandon/AP/Associated Press
Learning Objectives
After reading this chapter, you should be able to do the following:
• Illustrate how healthcare policies, rules and regulations, and guidelines impact quality of care.
• Analyze the role of accreditors, including The Joint Commission, along with major steps in the
accreditation of healthcare organizations.
• Evaluate the role of Leapfrog group on quality of healthcare and the methodology used to compute
the hospital safety score.
• Analyze the structure and process of the National Committee for Quality Assurance (NCQA)
accreditation for health plans.
• Assess the role of several government institutions on the quality of care.
fin81226_04_c04_073-118.indd 73 10/30/14 7:41 PM
Introduction
Introduction
At the turn of the 20th century, there were few federal regulations to protect the public from
dangerous drugs. Many harmful products were freely sold, such as William Radam’s Microbe
Killer and Benjamin Bye’s Soothing Balmy Oils to cure cancer. As is sometimes the case, trag-
edy brought about the first real regulation to protect consumers health and safety. The Bio-
logics Control Act was passed in 1902 after two incidents involving the deaths of children
caused by contaminated vaccines. The law mandated producers in the U.S. to be licensed each
year for the manufacture and sale of biologics such as antitoxins, serum, and vaccines to pre-
vent future tragedies from reoccurring. That was followed by the Pure Food and Drugs Act in
1906, which prohibited interstate commerce in misbranded and adulterated foods, drinks,
and drugs and mandated strict health safety and testing policies. The law was passed mainly
in response to shocking public disclosures of unsanitary conditions in meat packing plants, as
well as fears over poisonous preservatives and dyes in foods.
However, the 1906 law had its shortcomings and the government’s hands were tied when it
came to preventing the sale of medicinal products that carried wild claims of health cures.
In 1910, the government stopped sales of a product called Dr. Johnson’s Mild Combination
Treatment for Cancer, but the Supreme Court ruled in favor of the company because the prod-
uct’s false claims were not within the scope of the Pure Food and Drugs Act (Meadows, 2006).
As a result, in 1912, Congress passed the Sherley Amendment, which prohibited labels on
medicines that fals.
Impact of the Legalization of Marijuana on InsuranceRisk Nerds
My presentation to the Carolinas Chapter of the IASA (August 2014). Here I talk about the issues for insurance companies that are arising out of the legalization of recreational and medical marijuana.
The DEA and US Federal Government Just Bought Weed for ResearchEvergreen Buzz
Yes, the US government bought real weed, read this https://cannabis.net/blog/news/the-us-federal-government-just-bought-a-ton-of-marijuana-for-medical-research-for-the-first-tim
2. Law: The Combat Methamphetamine
Epidemic Act of 2005
Signed into law: March 9, 2006
by President George W. Bush
Law effective: September 30, 2006
http://georgewbush-whitehouse.archives.gov/news/releases/2006/03/images/20060309-4_d-0213-515h.html
3. Why enacted: To regulate over-the-counter
sales of ephedrine, pseudoephedrine, and
phenylpropanolamine used illegally to make
methamphetamine or amphetamine.
December 22, 2005: The FDA removed
phenylpropanolamine from the market due to
an increased risk of hemorrhagic stroke. Only
sold by prescription for animal use.
4. Amphetamine and methamphetamine are
dangerous and highly addictive drugs that are
made and used.
Common names used for the drug: “meth”,
“crystal”, “crank”, and “ice”
Methamphetamine can be made illegally from
ephedrine and pseudoephedrine.
Amphetamine can be illegally made from
phenylpropanolamine.
5. Was being manufactured in illegal labs and
homes in the United States
Drug side effects: irritability, nervousness,
insomnia, nausea, depression, and brain
damage
6. Pharmacies must:
Keep OTC medications containing ingredients
pseudoephedrine, ephedrine, and
phenylpropanolamine behind the counter or
in locked cabinets inaccessible from
customers until sale is made
Maintain an electronic or written logbook
listing sales (identifying products by name,
quantity sold, names and addresses of
customers, & dates/times of sales
7. Pharmacies must:
Limits sales: any solid and liquid form of
ephedrine, pseudoephedrine, and
phenylpropanolamine or combination to a
daily sales limit of 3.6 grams, & a monthly
purchase limit of 9 grams to the same
customer
Retain customer purchase information for 2
years after sale
8. To purchase customer must:
Present valid photo id or acceptable
documentation
Complete log book requirements for name,
address, date, time sale occurred, and
signature
Confirm the entry for the name of the
medication and quantity sold are correct
9. 1887 Lazar
Edeleanu
in Germany
develops related
drug amphetamine
predecessor to
meth
1893 Meth Developed
by Japanese chemist, Nagayoshi
Nagai used ephedrine to synthesize
meth from Ephedra sinica, a plant
used in Ayurvedic and Chinese
medicine
1919 Akira Ogata
“discovered a new
method of synthesizing
the crystalline form of
the new stimulant,
giving the world crystal
meth”
http://www.de.emb-japan.go.jp/NaJ/NaJ1210/nagai.html
http://thepoisondiaries.tumblr.com/post/3534
3648947/ephedra-sinica-a-plant-that-cures
Lazar Edeleanu. (n.d.). Retrieved from Humans And Alimentation,
Humans Mind: http://humansandalimentation.com/lazar-edeleanu/
10. 1986 1st attempt deter meth by DEA
number three agent Gene Haislip who
authors legislation that sellers of OTC
asthma & diet pills containing ephedrine &
manufacturers cold medicine keep sales
and import records
http://www.pbs.org/wgbh/pages/frontline/meth/interviews/haislip.html
11. 1988 DEA and pharmaceutical industry reach
compromised deal & pass bill after 2 years.
Exempts any chemical (ephedrine &
pseudoephedrine)
April – August 1995 Legislation approved in
1993 phased in requiring those selling
ephedrine pills be DEA registered, keep records
of sales, and report suspicious customers. Law
does not include pseudoephedrine pills.
12. 1) Made National restriction of pharmacies selling
ephedrine, pseudoephedrine, and
phenylpropanolamine requiring them to be in
locked case or kept behind counter and limiting
amount customers can purchase in a day & month.
2) Stronger penalties against smugglers, kingpins,
and meth cooks using federal property or
endangering children
3) More government authority to monitor main
drug chemicals required to make from foreign
manufacturers & withhold aid if uncooperative
13. 4) Make main drug chemical importers &
exporters accountable if drugs are
redirected for illegally used
5) Gave more funding to assistance
programs such as ones to help mothers or
drug-endangered children and drug courts
6) Set manufacturer production & import
quotas of ephedrine and pseudoephedrine
14. 7) Agreement to support Mexico in effort to
curb methamphetamine production
15. WWII Germany military used "flyer's
chocolate“ (chocolate with meth) or
"tanker's chocolate“ given to aircraft and
tank workers stay awake and increase
productivity
1942 – 1945 Adolf Hitler used IV injections
for depression & fatigue. Historians believe
used treat Parkinson’s disease or symptoms
resembling those of Parkinson’s
Summary Adolf Hitler. (n.d.). Retrieved from http://www.fold3.com:
http://www.fold3.com/page/83002428_adolf_hitler
16. March 1994 US customs agent stumbles
upon 3.4 metric tons of ephedrine on plane
traveling from Switzerland to Mexico.
DEA researches 18-month period and
realizes 170 tons ephedrine was smuggled
to US that could make 2 billion hits of meth
17. Occurred in Juneau, Alaska
Pharmacy records from local pharmacies of
individuals who purchased cold medication
for months was seized without warrant by law
enforcement.
Attorney argues statute allowing this was
illegal, but prosecutors say no warrant was
necessary.
18. Law enforcement looking for accomplices of
two men caught in Oct. 2012 warehouse
using plastic soda bottles to make meth
results in arrest of 5 residents of Juneau.
Attorney of one defendant in pretrial argued
that his client’s privacy under federal & state
constitutions along with freedom from
warrantless searches and seizures was
violated.
19. Attorney stated hundreds of individuals
information was taken without necessary
circumstances or suspicion for it.
State dismissed charges against defendant
before judge ruled, but argument will be used
in one codefendant’s case.
Law was written giving law enforcement
authority to request records at any time from
a store. If store does not provide records,
then they can be charged with a civil fine of
$10,000.
20. Cells phones were seized and sent to Alaska
State Troopers and compared against store
medication logs.
Defendant’s number was found on cell and
medication log showed defendant purchased
cold medication twice within 2 days causing
felony charges.
DA dismissed charges against defendant
noting it was not related to argument on
search and seizure legality, but did not
explain their reasons on case.
21. Two people in warehouse making meth
pleaded guilty to drug-related charges.
Two codefendants were waiting on trial in
newspaper article.
23. CMEA (Combat Methamphetamine Epidemic Act). (n.d.).
Retrieved from U.S. Department of Justice. Drug
Enforcement Administration. Office of Diversion Control.:
http://www.deadiversion.usdoj.gov/meth/q_a_cmea.htm#
13
Legal Requirements for the Sale and Purchase of Drug
Products Containing Pseudoephedrine, Ephedrine, and
Phenylpropanolamine. (2014 , 07 30). Retrieved from U.S.
Food and Drug Administration:
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrug
Class/ucm072423.htm
President Signs USA PATRIOT Improvement and
Reauthorization Act. (2006, 03). Retrieved from The WHITE
HOUSE PRESIDENT GEORGE W. BUSH: http://georgewbush-
whitehouse.archives.gov/news/releases/2006/03/images/
20060309-4_d-0213-515h.html
24. Phenylpropanolamine (PPA) Information Page. (2010, 9
03). Retrieved from U.S Food and Drug Administration:
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrug
Class/ucm150738.htm
The History of Crystal Meth. (2014, 11 28). Retrieved from
AddictionSearch the latest addiction Information:
http://www.addictionsearch.com/treatment_articles/articl
e/the-history-of-crystal-meth_58.html
Lazar Edeleanu. (n.d.). Retrieved from Humans And
Alimentation, Humans Mind:
http://humansandalimentation.com/lazar-edeleanu/
Nagayoshi Nagai (1845-1929). (2012, 10). Retrieved from
Botschaft von Japan in Deutschland: http://www.de.emb-
japan.go.jp/NaJ/NaJ1210/nagai.html
25. Alnwick, D. L. (2014). EPHEDRA SINICA; A PLANT THAT CURES….
Retrieved from THE POISON DIARIES:
http://thepoisondiaries.tumblr.com/post/35343648947/ephedr
a-sinica-a-plant-that-cures
Timeline. (2006, 03 22). Retrieved from http://www.pbs.org:
http://www.pbs.org/wgbh/pages/frontline/meth/etc/cron.html
THE COMBAT METHAMPHETAMINE EPIDEMIC ACT OF 2005.
(2011, 05 16). Retrieved from http://www.pbs.org:
http://www.pbs.org/wgbh/pages/frontline/meth/etc/updnation
al.html
Summary Adolf Hitler. (n.d.). Retrieved from
http://www.fold3.com:
http://www.fold3.com/page/83002428_adolf_hitler/
Miller, R. E. (2013, 05 16). Cases challenge legality of anti-
"smurfing" statute. Retrieved from JuneauEmpire.com:
http://juneauempire.com/local/2013-05-16/cases-challenge-
legality-anti-smurfing-statute
26. CMEA (Combat Methamphetamine Epidemic Act). (n.d.). Retrieved from US.
Department of Justice. Drug Enforcement Administration Office of Diversion
Control: http://www.deadiversion.usdoj.gov/meth/q_a_cmea.htm#2
DEA has developed training materials regarding self-certification training -
Training Required to Sell. (n.d.). Retrieved from U.S. Department of Justice:
http://www.pharmacy.ca.gov/licensing/combat_methamphetamine.pdf
Editor's Notes
Source: CMEA (Combat Methamphetamine Epidemic Act). (n.d.). Retrieved from U.S. Department of Justice. Drug Enforcement Administration. Office of Diversion Control.: http://www.deadiversion.usdoj.gov/meth/q_a_cmea.htm#13
Legal Requirements for the Sale and Purchase of Drug Products Containing Pseudoephedrine, Ephedrine, and Phenylpropanolamine. (2014 , 07 30). Retrieved from U.S. Food and Drug Administration: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm072423.htm
Picture: President Signs USA PATRIOT Improvement and Reauthorization Act. (2006, 03). Retrieved from The WHITE HOUSE PRESIDENT GEORGE W. BUSH: http://georgewbush-whitehouse.archives.gov/news/releases/2006/03/images/20060309-4_d-0213-515h.html
Source: Legal Requirements for the Sale and Purchase of Drug Products Containing Pseudoephedrine, Ephedrine, and Phenylpropanolamine. (2014 , 07 30). Retrieved from U.S. Food and Drug Administration: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm072423.htm
CMEA (Combat Methamphetamine Epidemic Act). (n.d.). Retrieved from US. Department of Justice. Drug Enforcement Administration Office of Diversion Control: http://www.deadiversion.usdoj.gov/meth/q_a_cmea.htm#2
Phenylpropanolamine (PPA) Information Page. (2010, 9 03). Retrieved from U.S Food and Drug Administration: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm150738.htm
DEA has developed training materials regarding self-certification training - Training Required to Sell. (n.d.). Retrieved from U.S. Department of Justice: http://www.pharmacy.ca.gov/licensing/combat_methamphetamine.pdf
Source: DEA has developed training materials regarding self-certification training - Training Required to Sell. (n.d.). Retrieved from U.S. Department of Justice: http://www.pharmacy.ca.gov/licensing/combat_methamphetamine.pdf
Source: Legal Requirements for the Sale and Purchase of Drug Products Containing Pseudoephedrine, Ephedrine, and Phenylpropanolamine. (2014 , 07 30). Retrieved from U.S. Food and Drug Administration: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm072423.htm
Source: Legal Requirements for the Sale and Purchase of Drug Products Containing Pseudoephedrine, Ephedrine, and Phenylpropanolamine. (2014 , 07 30). Retrieved from U.S. Food and Drug Administration: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm072423.htm
Source: CMEA (Combat Methamphetamine Epidemic Act). (n.d.). Retrieved from U.S. Department of Justice. Drug Enforcement Administration. Office of Diversion Control.: http://www.deadiversion.usdoj.gov/meth/q_a_cmea.htm#13
Legal Requirements for the Sale and Purchase of Drug Products Containing Pseudoephedrine, Ephedrine, and Phenylpropanolamine. (2014 , 07 30). Retrieved from U.S. Food and Drug Administration: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm072423.htm
Source: Legal Requirements for the Sale and Purchase of Drug Products Containing Pseudoephedrine, Ephedrine, and Phenylpropanolamine. (2014 , 07 30). Retrieved from U.S. Food and Drug Administration: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm072423.htm
Source: The History of Crystal Meth. (2014, 11 28). Retrieved from AddictionSearch the latest addiction Information: http://www.addictionsearch.com/treatment_articles/article/the-history-of-crystal-meth_58.html
Lazar Edeleanu. (n.d.). Retrieved from Humans And Alimentation, Humans Mind: http://humansandalimentation.com/lazar-edeleanu/
Pictures: Nagayoshi Nagai (1845-1929). (2012, 10). Retrieved from Botschaft von Japan in Deutschland: http://www.de.emb-japan.go.jp/NaJ/NaJ1210/nagai.html
Alnwick, D. L. (2014). EPHEDRA SINICA; A PLANT THAT CURES…. Retrieved from THE POISON DIARIES: http://thepoisondiaries.tumblr.com/post/35343648947/ephedra-sinica-a-plant-that-cures
Source:Timeline. (2006, 03 22). Retrieved from http://www.pbs.org: http://www.pbs.org/wgbh/pages/frontline/meth/etc/cron.html
Picture: Interview Gene Haislip. (2006, 02 14). Retrieved from www.pbs.org: http://www.pbs.org/wgbh/pages/frontline/meth/interviews/haislip.html
Source: Timeline. (2006, 03 22). Retrieved from http://www.pbs.org: http://www.pbs.org/wgbh/pages/frontline/meth/etc/cron.html
Source: THE COMBAT METHAMPHETAMINE EPIDEMIC ACT OF 2005. (2011, 05 16). Retrieved from http://www.pbs.org: http://www.pbs.org/wgbh/pages/frontline/meth/etc/updnational.html
Source: THE COMBAT METHAMPHETAMINE EPIDEMIC ACT OF 2005. (2011, 05 16). Retrieved from http://www.pbs.org: http://www.pbs.org/wgbh/pages/frontline/meth/etc/updnational.html
Source: THE COMBAT METHAMPHETAMINE EPIDEMIC ACT OF 2005. (2011, 05 16). Retrieved from http://www.pbs.org: http://www.pbs.org/wgbh/pages/frontline/meth/etc/updnational.html
Source: The History of Crystal Meth. (2014, 11 28). Retrieved from AddictionSearch the latest addiction Information: http://www.addictionsearch.com/treatment_articles/article/the-history-of-crystal-meth_58.html
Picture: Summary Adolf Hitler. (n.d.). Retrieved from http://www.fold3.com: http://www.fold3.com/page/83002428_adolf_hitler/
Source: Timeline. (2006, 03 22). Retrieved from http://www.pbs.org: http://www.pbs.org/wgbh/pages/frontline/meth/etc/cron.html
Source: Miller, R. E. (2013, 05 16). Cases challenge legality of anti-"smurfing" statute. Retrieved from JuneauEmpire.com: http://juneauempire.com/local/2013-05-16/cases-challenge-legality-anti-smurfing-statute
Source: Miller, R. E. (2013, 05 16). Cases challenge legality of anti-"smurfing" statute. Retrieved from JuneauEmpire.com: http://juneauempire.com/local/2013-05-16/cases-challenge-legality-anti-smurfing-statute
Source: Miller, R. E. (2013, 05 16). Cases challenge legality of anti-"smurfing" statute. Retrieved from JuneauEmpire.com: http://juneauempire.com/local/2013-05-16/cases-challenge-legality-anti-smurfing-statute
Source: Miller, R. E. (2013, 05 16). Cases challenge legality of anti-"smurfing" statute. Retrieved from JuneauEmpire.com: http://juneauempire.com/local/2013-05-16/cases-challenge-legality-anti-smurfing-statute
Source: Miller, R. E. (2013, 05 16). Cases challenge legality of anti-"smurfing" statute. Retrieved from JuneauEmpire.com: http://juneauempire.com/local/2013-05-16/cases-challenge-legality-anti-smurfing-statute