Download Key Legislation in US Pharmacy History: A Comprehensive Review and more Exams Pharmacy in PDF only on Docsity!
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1. Pure Food and Drug Act of 1906: All manufacturers are required to properly label
a drug with truthful information, prove effectiveness, prohibited the adulter- ation and misbranding of food and drugs in interstate commerce.
• Helped passed by chief chemist for the Bureau of Chemistry, Harvey Wiley.
2. Harrison Narcotics Tax Act of 1914: Stop the recreational use of opium.
Implemented to regulate and tax the distribution, importation, and production of opiates.
3. Sulfanilamide Tragedy of 1937: Led to the passage of the Food, Drug, and
Cosmetic Act of 1938, more than 100 people died after the use of sulfanilamide. Dissolved sulfanilamide into diethylene glycol (antifreeze).
4. Food, Drug, and Cosmetic Act of 1938: Banned false claims, required pack- age
inserts with directions to be included with products, and required exact labeling on the product. Addictive substances to be labeled with the statement, Warning: May be Habit Forming.
5. Durham-Humphrey Amendment of 1951: • Created a distinction between
"OTC" and "Legend Drugs".
• Legend Drugs can only be dispensed with a valid Prescription.
• Required Legend Drugs to carry the statement:
"Caution: Federal law prohibits dispensing without a prescription.".
• Most people refer to Legend drugs simply as "Prescription Drugs".
• The emphasis on this act was to insure safety thru qualified medical supervision.
6. Thalidomide Tragedy of 1962: 10,000 children died from a Thalidomide side
effect, was marketed as a sedative and hypnotic used for insomnia, anxiety and gastritis. Led to stricter drug research, development, and regulations.
7. Kefauver-Harris Amendment of 1962: • Also known as the "Drug Efficacy
Amendment".
• Required drug manufacturers to provide proof of the effectiveness and safety of
their drugs before approval.
• Required drug advertising to be more closely regulated and disclose accurate
information about side effects
8. Comprehensive Drug Abuse Prevention and Control Act of 1970 or Con- trolled
Substances Act (CSA): Strictly controls the manufacture, importation, possession, use, and distribution of certain controlled substances. Narcotics, stimulants, depressants, hallucinogens, anabolic steroids, and other regulated chemicals.
• The DEA and FDA oversee the CSA.
• The CSA implemented a scheduled class of narcotics based on abuse potential
system of generic drug regulation in the United States.
• Outlines the process for drug companies to file an Abbreviated New Drug
Application (ANDA) to receive approval of a generic drug.
• First company that files an ANDA for a generic drug has 180 days of exclusive rights
to market the generic alternative to the brand drug.
16. Prescription Drug Marketing Act of 1987: Helps prevent counterfeit drugs by
providing legal safeguards in the chain of distribution of pharmaceuticals. It was designed to prevent the sales of discontinued, counterfeit, misbranded, subpar, and expired prescription drugs.
17. Omnibus Budget Reconciliation Act (OBRA) of 1990: Related to COBRA, allows
for continuing coverage and benefits of group healthcare plans for an em- ployee and family based upon certain qualifying issues and events when benefits would otherwise be terminated.
18. FDA Safe Medical Devices Act of 1990: All medical devices are to be tracked and
records maintained for durable medical equipment.
19. Anabolic Steroids Control Act of 1990: This act places "any drug or hor- monal
substance chemically and pharmacologically related to testosterone" under regulatory provisions of the Controlled Substance Act. CIII controlled substances
20. Americans with Disabilities Act of 1990: A law passed in 1990 that requires
employers and public facilities to make "reasonable accommodations" for people with disabilities and prohibits discrimination against these individuals in employ- ment.
21. Dietary Supplement Health and Education Act of 1994: Defines and regu- lates
dietary supplement under the FDA's Good Manufacturing Practices. Dietary supplements must have proper labeling.
22. Health Insurance Portability and Accountability Act (HIPAA) of 1996: Es-
tablished Protected Health Information (PHI). Privacy rules implemented by HIPAA are meant to protect certain health information, including the use and disclosure of a patient's PHI.
23. FDA Modernization Act of 1997: updated the Food, Drug, and Cosmetic Act to
include technological, trade, and public health issues more relevant to the 21st century.
24. Medicare Prescription Drug Improvement and Modernization Act of 2003-
: Gave low-income patients who need assistance with increasing drug costs the option of a prescription drug discount card.
• This act helps increase access to medical treatment and reduces unnecessary
hospitalizations associated with noncompliance in taking prescription drugs.
or pay a penalty.
• Creates Pre-Existing Condition Insurance Plan for those individuals who had been
denied coverage due to pre-existing conditions.
• Allows parents to keep their children on their plan until age 26.
• Creates insurance exchanges for individuals and employers.
27. Drug Quality and Security Act of 2013: Outlines steps to build an electronic
tracking system to identify and trace specific prescription drugs distributed in the US.
28. Bureau of Alcohol, Tobacco, Firearms, and Explosives (ATF): Federal or-
ganization within the US Department of Justice. The ATF combats terrorism, arson and violent crime; regulates alcohol, tobacco, firearms, arson, and explosives.
29. State Boards of Pharmacy (BOP): • Regulatory state agency that *oversees the
practice of pharmacy* in a given state.
• Define regulations affecting pharmacy and the roles, duties, and expectations of
pharmacists and pharmacy technicians in that state.
• Establish criteria for continuing education for both pharmacists and possibly
pharmacy technicians to remain credentialed for their profession.
• Have the authority to discipline pharmacies, pharmacists, and possibly pharmacy
technicians for improper behavior. Determines the regulations affecting generic substitution in state.
30. National Association of Boards of Pharmacy (NABP): Assists the boards of
pharmacy in each state to protect public health by developing uniform standards
31. Centers for Medicare and Medicaid Services (CMS): Promotes Medicare,
Medicaid, and government plans in regards to healthcare coverage.
32. Environmental Protection Agency (EPA): The US federal agency with a
mission to protect human health and the environment. Watch for bacteria and viruses in the environment that could become a risk to the human poplation.
33. Medwatch: FDA's safety and adverse event reporting program
34. The Joint Commission: a not-for-profit organization that evaluates and ac-
credits different types of healthcare facilities. Accredits hospitals through yearly inspections for compliance and national patient safety goals.
35. Respondeat Superior: "Let the master answer" an employer is vicariously liable
for the behavior of an employee working within his or her scope of employ- ment.
36. DEA Form 224: Application for New Registration
Retail = 9g
43. American Drug Index: Identifies and describes thousands of prescription
drugs in a dictionary format.
• Available in print and online.
44. American Hospital Formulary Service Drug Information: Provides drug
information with therapeutic guidelines and off-label uses.
• Written and published by pharmacists and available online.
45. Drug Facts and Comparisons: A book the compiles information on 22,
prescription and 6,000 OTC products, it lists products by therapeutic categories. It includes actions of drugs, warnings and precautions, interactions, adverse reac- tions, administration and dosage, contraindications and indications, dosages, and brand and generic names.
• Available online
46. Geriatric Dosage Handbook: Provides geriatric sensitive doing information as
well as information about drug interactions and dosing in the elderly. It includes a risk assessment of drugs that should be avoided or used with caution in older adults.
• Written by Todd P. Semla
• Dictionary formatted, available in PDF format.
47. Goodman and Gilman's The Pharmacological Basis of Therapeutics: Em-
phasizes the relationship between pharmacotherapy and pharmacodynamics.
• Nick named the Blue Bible
• Published in 1941, available in PDF format
48. Handbook of Nonprescription Drugs: Contains information on nonprescrip- tion
drugs and self-care. It includes pharmacotherapy, medical foods, nutritional supplements, nodrug and preventative measures, and therapies unrelated to the use of prescription drugs.
• Available in PDF format.
49. Ident-A-Drug: Online and print pill identifier presents drugs by shape, imprints,
and color. The site provides an illustration of the drug including the brand and generic name, manufacturer, and purpose.
50. Martindale's The Complete Drug Reference: An unbiased and evaluated re-
source book on drugs used internationally. Provides international disease reviews and drug preparations.
51. Micromedex Healthcare Evidence and Clinical Xpert: Includes evidence
53. Pediatric and Neonatal Dosage Handbook: Gives Important dosing infor-
mation and evaluations for the management of pediatric patients by healthcare professionals.
• Written by Jane Hodding and Donna M. Kraus
54. The Pharmacy Technician's Pocket Drug Reference: Small, portable book
provides brand and generic drug names, illustrations, therapeutic class, dosage forms and strengths, and therapeutic uses.
55. The Physician's Desk Reference (PDR): A compilation of annually updated
manufacturers' prescribing information (package inserts) on prescription drugs.
• Available online
56. Red Book: Pharmacy's Fundamental Reference: A resource on drug pric- ing. It
includes information about prescription pricing and order entry, forecasting, competitive analysis, formulary development management, claims adjudications, processing, reimbursement information, and AWP policies.
• Available in print and online
57. Remington's The Science and Practice of Pharmacy: A reference and text- book
on the science and practice of pharmacy includes pharmacy curriculum and professional pharmacy practice guidelines.
58. Trissel's Handbook on Injectable Drugs: Gives extensive information on
injectable drugs available in the US and internationally. It explains in detail how to prepare, store, and administer injectable drugs. The handbook also gives infor- mation on drug stability and compatibility.
59. The United States Pharmacopeial Convention's Pharmacopeia (USP): A body of
information on the standards of strength, purity, and quality of drugs, this publication was made legal standard in 1907 and is revised periodically.
• Available online
60. United States Pharmacopeia-National Formulary (USP-NF): A compilation of
both the USP and the National Formulary; it includes standards for botanical, excipients, and other similar products. In 1975 the USP and NF were combined into one book.
61. Receptor: A protein molecule in a cellular membrane that can bind to a
complementary molecule.
62. Agonist: A chemical capable of activating a receptor to generate a therapeutic
response.
63. Bioavailability: The usable amount of the drug that reaches the body's circu-
lation.
(EC50) and half maximal inhibitory concentration (IC50). EC50 refers to the concentration of the drug after a specific exposure time that activates a response halfway between the baseline and maximum dose. IC50 measures how much of a dose is needed to activate a biochemical function.
71. -olol: Beta-blockers (B1) or beta-adrenergic blocking agents
• Block adrenaline receptors and mediate a fight-or-flight response, causing action in
the heart.
• These drugs affect the cardiovascular system
• Common side effects: fatigue, cold hands, upset stomach, constipation, diarrhea,
dizziness, shortness of breath, trouble sleeping, erectile dysfunction, depression,
bradycardia, hypotension/syncope.
• Common interactions: Amiodarone, clonidine, diltiazem, fluconazole, reserpine,
refampin, verapamil, MAO inhibitors, and alcohol.
• Propranolol (Inderal), acebutolol (Sectral), atenolol (Tenormin), betaxolol (Ker- lone),
bisoprolol (Zebeta), carvedilol (Coreg), metoprolol (Lopressor), nadolol (Cor- gard), penbutolol (Levatol), pindolol (Visken)
72. -tidine: Histamine-2 blockers
• Reduce the amount of acid in the stomach.
• These drugs affect the digestive system.
• Common side effects: diarrhea, dizziness, headache, and swollen breasts.
• Ranitidine (Zantac), Famotidine (Pepcid), cimetidine (Tagamet), nizatidine (Axid)
73. -cycline: Antibiotics (tetracycline type)
• Inhibit the growth of or kill bacterial microorganisms
• These drugs affect the immune system.
• Doxycycline
74. -actone: Potassium-sparing diuretics
• Increase urine flow and enhance sodium loss.
• These drugs affect the cardiovascular system.
• Common side effects: dry mouth, muscle twitching, muscle weakness, loss of
appetite, diarrhea, stomach cramps and ringing in the ears.
• Spironolactone (Aldactone)
75. -statin: HMG-CoA reductase inhibitors
• Inhibit cholesterol production.
• These drugs affect the cardiovascular system.
• Common side effects: Diarrhea, lower back pain, tiredness, muscle cramps,
headache, hoarseness, constipation, gas, heartburn, loss of appetite, and trouble
• These drugs affect the immune system.
• Penicillin, Ampicillin
78. -artan: Angiotensin II Recptor Blockers (A2RB)
• Block angiotensin II enzymes from specific receptor sites and help prohibit
vasoconstriction.
• These drugs affect the cardiovascular system.
• Common side effects: Changes in urination, weakness, wight gain, lightheaded- ness,
and fainting.
• Common interactions: Blood pressure medications, NSAIDs, anything containing
potassium and alcohol.
• Candesartan (Atacand), irbesartan (Avapro), losartan (Cozaar), telmisartan (Mi-
cardis), valsartan (Diovan).
79. -vir: Antivirals
• Inhibit the growth of or kill viral microorganisms.
• These drugs affect the immune system.
• Oseltamivir
80. -floxacin: Antibiotics
• Inhibit the growth of or kill bacterial microorganisms.
• These drugs affect the immune system.
• Moxifloxacin
81. -pril: Angiotensin-Converting-Enzyme (ACE) Inhibitor
• Block the conversion of angiotensin I to angiotensin II; they may also reduce the
chance of increased vasoconstriction or blood pressure.
• These drugs affect the cardiovascular system.
• Common side effects: dry cough, nausea, vomiting, loss of appetite, and stomach
discomfort.
• Common interactions: Some blood pressure medicines, insulin, diabetes medica-
tions, NSAIDs, arthritis medications, aliskiren, and alcohol.
• Enalapril (Vasotec), benazepril (Lotensin), captopril (Capoten), fosinopril (Mono- pril),
lisinopril (Zestril/Prinivil), moexipril (Univasc), quinapril (Accupril), ramipril (Altace), trandolapril (Mavik)
82. -azosin: Alpha Adrenergic Blockers
• Relaxes the veins and arteries so blood can easily pass through; antihyperten- sives.
• These drugs affect the cardiovascular system.
• Common side effects: headache, tiredness, dizziness, painful and prolonged
erection and alcohol.
• Common interactions: sildenafil, tadalafil, vardenafil, beta blockers, and diuretics.
