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1. 1906 Federal Food and Drug Act
ANS Prohibits the sale of adulterated or misla- beled food, drinks, and drugs
2. 1914 Harrison Narcotic Act
ANS Limits the transport of opium. In order to purchase opium, a prescription is needed.
3. 1938 Food Drug and Cosmetic Act
ANS Requires drug companies to provide package inserts. Requires that a habit- forming drug to be labeled "may be habit forming." Requires that a new drug has to be proven safe under FDA guidelines before marketing.
4. 1951 Durham Humphrey Amendment
ANS Distinguishes legend drugs (prescrip- tion) from OTC. Requires companies to label legend drugs "Caution Federal law prohibits dispensing without a prescription." Requires physician supervision for the purchase of legend drugs. OTC's without medical supervision are required to have on the label product name, name and address of manufacturer/distributor, active ingredients, quantities of all other ingredients
5. 1962 Kefauver-Harris Amendment
ANS All drugs made from 1938 forward have to be proven safe and effective. Enacted due to birth defects caused by thalidomide in Europe. Requires "good manufacturing practices" (GMP), Stricter requirements for drug manufacturers for drug approval, FTC (federal trade commission) not FDA handle drug advertisement, Requires
manufacturer must register annually, report adverse reactions, be inspected every 2yrs
6. 1970 Comprehensive Drug Abuse Prevention and Control Act (Controlled
Substance Act-CSA) ANS DEA was formed. Placed controlled drugs into schedules 1-5 based on abuse potential. Schedule 1 have highest potential for abuse.
7. 1970 Poison Prevention Packaging Act
ANS Requires child proof packaging on most drugs. Exempt drugs are used in emergency like nitroglycerin or if drug is packages in small quantity it would not harm child under 5.
8. 1983 Orphan Drug Act
ANS Enables FDA to promote research and marketing of drugs needed for rare diseases. These drugs are made for a small % of population that drug's demand does not make marketing and manufacturing in large qty economically feasible.
9. 1984 Drug Price Competition and Patent-Term Restoration Act
(Hatch-Waxman Amendment) ANS Streamlines process for granting approval of generic drugs. Gives manufacturers incentives to develop new drugs w/ patent extensions. Allows generic drug companies ability to rely on safety and efficacy findings of an innovator's drug after expiration of patent
10. 1988 Food and Drug Administration Act
ANS Establish FDA as agency of De- partment of Health and Human Services. In 1988
ANS
Name of product, address of manufacturer, packer, or distributor. Net contents. ALL active ingredients. Any habit forming drugs. Adequate directions- drug's intended conditions and purposes, normal dose, frequency and duration, method of use.
18. FDCA requires prescription labels to contain
ANS
Name, address and phone # of pharmacy, patient and doctor's name, prescription # and date filled, name of drug, strength, qty, directions, initials of pharmacist and/or tech, patient's address, expiration, refills, package insert on selected drugs, and "federal law prohibits dispensing without a prescription."
19. Package inserts must contain
ANS
Description of drug, clinical pharmacology, indications and usage, warnings and contraindications, dependence and overdose info, date of most recent labeling revision.
20. Package inserts must be distributed with
ANS
Oral contraceptives, estro- gen-containing and pro gestational drugs, intrauterine contraceptive devices, di- ethylstilbestrol products, accutane, metered-dose inhalers
21. National Drug Code (NDC)
ANS First 5 numbers identify manufacturer, next 4 numbers identify a specific drug by the manufacturer, last 2 numbers identify package size
22. Schedule 1 drugs
ANS NO accepted medicinal use in US. Heroin, Peyote, LSD, Marijuana, Msscaline
23. Schedule 2 drugs
ANS No refills, ordering requires DEA 222 form, high abuse potential
24. Schedule 3 drugs
ANS May be refilled 5 times in 6 month period. Less potential for abuse or dependence. Marinol (Drobabinol), Anabolic steroids (testosterone)
25. Schedule 4 drugs
ANS Refill 5 times in 6 months, less potential for abuse or dependence, Benzodiazepines (alprazolam, diazepam, lorazepam), Phentermine, Pentazocine, Phenobarbital, Diethylpropion
26. Schedule 5 drugs
ANS Less potential for abuse or dependence. Examples anti- tussives with codeine, antidiarrheals with opioid.
27. How often should a controlled substance inventory be done?
ANS At least once every 2 years
28. How long must controlled substance records be kept?
36. -floxacin
ANS Antibiotic; Fluoroquinolones
37. Ceph-, cef-
ANS Antibiotic; Cephalosporins
38. -cillin
ANS Antibiotic; Penicillins
39. -cyclovir
ANS Antiviral; Anti-Herpetics
40. -pril
ANS Antihypertensive (high blood pressure); angiotensin converting enzyme- inhibitors (ACEI's)
41. -sartan
ANS Antihypertensive (high blood pressure); Angiotensin II Recep- tor-Blockers (ARB's)
42. -osin
ANS Antihypertensive, Benign Prostatic Hyperplasia (BPH); a1-Receptor Blockers
43. -olol
ANS Antihypertensive (high blood pressure); Cardioselective, b-receptor blockers, nonselective b-receptor blockers, ISA(intrinsic sympathomimetic activi- ty), mixed a&b- receptor blockers
44. -dipine
ANS Antihypertensive (high blood pressure); Calcium Channel Blockers (CCB's)
45. -statin
ANS Antihyperlipidemia (high cholesterol); HMG-CoA reductase inhibitors
46. -glitazone
ANS Antidiabetic (Thiazolidinediones)
47. -glinide
ANS Antidiabetic; Meglitinides
48. -dronate
ANS Osteoporosis; Bisphosphonates
49. -tidine
ANS Anti-ulcer; H2-Receptor Antagonists
50. -prazole
ANS Anti-ulcer; Proton Pump Inhibitors (PPI's)
51. -triptan
ANS Anti-migraine; 5-HT1 Receptor Antagonists (Triptan's)
52. -pam, -lam
ANS Anti-anxiety/Hypnotics; Benzodiazepines (BZD's)
53. -pramine
ANS Antidepressants; Tricyclic Antidepressants (TCA's)
54. -triptyline
ANS Antidepressants; Tricyclic Antidepressants (TCA's)
61. -mide, -nide
ANS Antihypertensive (high blood pressure); diuretics (water)
62. Clindamycin (Cleocin) is not a macrolide. What is it?
ANS Lincomycin
63. Type 1 diabetes
ANS Insulin dependent, diagnosed in early childhood. Body pro- duces no insulin due to the autoimmune degradation of beta cells in the pancreas and islet cells.
64. What are the different types of insulin?
ANS Rapid acting, short acting, interme- diate acting, and long acting
65. How do most diabetic oral medications work?
ANS By either stimulating the production of insulin or prohibiting the release of glucose into the body
66. If a patient is injecting 20 units per dose, what size syringe would the
patient need? ANS 3/10cc (30 units)
67. What are the two types of long acting insulin?
ANS Lantus and Levemir
68. What are the rapid acting types of insulin?
ANS Humalog, Novolog, Apidra, and Exubera(inhalation)
69. What are the short acting types of insulin?
ANS Humulin R, Novolin R
70. What are the intermediate acting types of insulin?
ANS Humulin N, Novolin N, Lente
71. What are the non-insulin injectables?
ANS Byetta, Symlin
72. Type 2 diabetes
ANS Non-insulin dependent, caused by lifestyle choices
73. -ide
ANS Sulfonylureas; increase beta cell insulin secretion
74. When ordering C3 medication what document is required for proof of
receipt? ANS Commercial invoice
75. Because federal and state record keeping requirements can vary in each
state, which law should be followed? ANS Most stringent
76. For general laws concerning pharmacy rules and regulations, which law
should be followed? ANS Most stringent
77. What do the middle four numbers of a NDC number indicate?
ANS A specific drug
78. To whom are drug recalls, drug reactions and outcomes reported?
ANS FDA
81. Who may initiate the ordering of an investigational drug??
ANS Physician
82. Which drug recall must go to the customer level?
ANS Class 1
83. Which form is used to report lost or stolen drugs?
ANS DEA 106
84. Which schedule has no legal medicinal use?
ANS Schedule 1
85. Which drug does not require a childproof closure?
ANS Nitroglycerin
86. Which form is used when ordering C2 drugs?
ANS DEA 222
87. Glucagon is used...
ANS When a patient has low blood sugar (hypoglycemia)
88. Which insulin is cloudy?
ANS Humulin N
89. How long is insulin good outside of refrigeration?
ANS 28 days
90. Which insulin comes in an inhalation dosage form?
ANS Exubera
91. Which insulin can be given IV?
ANS Humulin R
92. Which class of drugs is used to treat diabetes?
ANS Sulfonylureas
93. Glyburide is used to treat what disease?
ANS Diabetes mellitus
94. Insulin is used to treat which condition?
ANS Hyperglycemia
95. What is the proper temperature for insulin storage?
ANS 36-46 degree Fahren- heit
96. Hypoglycemia is defined as.
ANS Low blood sugar
97. Which type of diabetes is usually diagnosed in childhood?
ANS Type 1
98. Which type of diabetes is known as insulin dependent diabetes mellitus?-
ANS Type 1
99. Humulin N is injected by which route of administration?
ANS SC
100. Which type of injection offers the quickest onset of action?
ANS IV
101. An HbA1C test will show glucose control over what period of time?
106. Armour Thyroid 1 grain is equivalent to how many milligrams?
ANS 60 mg
107. How often is Boniva (Ibandronate) taken?
ANS Once a month
108. How often are Actonel (risedronate) 35 mg and Fosamax (alendronate) 35
mg and 75 mg taken? ANS Once weekly
109. Biphosphonates "-dronates" should be taken....
ANS -with 6-8 oz of water -first thing in the morning before eating or drinking anything -do not lie down, eat, drink (other than water), or take any other meds for at least 30 min this will reduce risk of irritation and/or erosion of the esophagus
110. How is Miacalcin (calcitonin-salmon) stored prior to dispensing?
ANS Re- frigeration
111. How is Miacalcin (Calcitonin-Salmon) administered?
ANS Intranasal
112. What is the dosing frequency for Boniva?
ANS Once monthly
113. How is Fosamax (alendronate) taken?
ANS 30 minutes before breakfast and with water only
114. What is the dosing frequency of Fosamax 70mg?
ANS Once weekly
115. Why should a patient not lie down after taking Biphosphonates?
ANS Ero- sion of the esophagus
116. What is hypertension caused by?
ANS The resistance of blood flow through blood vessels
117. What is an ideal blood pressure reading?
ANS 120/80 mm Hg (systolic/ dias- tolic)
118. What is a common side effect of betablockers?
ANS Orthostatic hypotension (lightheadedness upon standing)
119. Where are beta 1 receptors?
ANS Heart and kidneys
120. Where are beta 2 receptors located?
ANS Lungs, liver, pancreas, and arteriolar smooth muscle
121. Since beta 2 receptors are in the lungs and pancreas, they should be used
very cautiously in patients with , , and. ANS Asthma, COPD, and diabetes
122. How do betablockers work in hypertensive patients?
ANS By binding to Beta 1 receptors, which decreases heart rate, cardiac output, and causes relaxation of blood vessels
130. Diuretics-loop diuretics
ANS Furosemide, torsemide, bumetanide
131. When should patients take diuretics?
ANS In the morning due to increased urination
132. What is typically taken with diuretics?
ANS Potassium due to increased potas- sium loss
133. Alpha2-Adrenergic Agonists
ANS Clonidine, tizanidine, guanfacine
134. Alpha-Adrenergic Inhibitors
ANS Methyldopa
135. Alpha Adrenergic Blockers
ANS Doxazosin, terazosin, prazosin, alfuzosin, tam- sulosin
136. What is nitroglycerin contraindicated with?
ANS Viagra, Cialis, and Levitra due to possible prolonged hypotension
137. What are anticoagulants (blood thinners) used to treat or prevent?
ANS Ve- nous thrombosis, stroke, or myocardial infarction by slowing down the blood clotting process.
138. Anticoagulants examples
ANS Heparin, Warfarin, Enoxaparin
139. What is warfarin contraindicated with?
ANS Aspirin and NSAIDS
140. What are major side effects of warfarin?
ANS Bruising and increased bleeding time
141. Cholesterol and Lipid Lowering drugs
ANS Lovastatin, simvastatin, pravas- tatin, atorvastatin
142. When are "statins" usually taken?
ANS Evening
143. What are common side effects of "statins"?
ANS Leg cramps, muscle degen- eration, liver damage
144. Triglyceride reducers
ANS Gemfibrozil & Fenofibrate
145. What are other miscellaneous Cholesterol Lowering Drugs?
ANS Cholestyra- mine, Niacin, Colestipol, Zetia, Omega 3
146. What is a side effect of Niacin?
ANS Flushing- which can be prevented by pre-treating with aspirin 1/2 to 1 hr before taking Niacin
147. Which suffix is generally associated with betablockers?
ANS -olol
148. Which suffix is generally associated with ACE inhibitors?
