Pharma Exam 1

Question 1

The Durham-Humphrey Amendment

Answer 1

designates drugs that must be prescribed by a licensed physician or nurse practitioner and dispensed by a pharmacist. The U.S. Food and Drug Administration (FDA) is charged with enforcing the law.

Question 2

The Drug Enforcement Administration (DEA)

Answer 2

Enforces the Controlled Substances Act. Individual
people and companies legally empowered to handle controlled substances must register with the DEA, keep accurate records of all transactions, and provide for secure storage. The DEA assigns prescribers a number, which they must include on all prescriptions they write for a controlled substance.

Question 3

Controlled Substances Act

Answer 3

Regulates the manufacture and distribution of narcotics, stimulants, depressants, hallucinogens, and anabolic steroids and requires the pharmaceutical industry to maintain physical security and strict record keeping for these drugs and substances. The Drug Enforcement Administration (DEA) enforces the Controlled Substances Act.

Question 4

FDA role in approving new drugs

Answer 4

The FDA is responsible for ensuring that new drugs are safe and effective before approving the drugs and allowing them to be marketed. The FDA reviews research studies (usually conducted or sponsored by pharmaceutical companies) about proposed new drugs; the organization does not test the drugs.

Question 5

Phases of testing new medication

Answer 5

Phase 1, a few doses are given to a certain number of healthy volunteers to determine safe dosages, routes of administration, absorption, metabolism, excretion, and toxicity.
Phase 2, a few doses are given to a certain number of subjects with the disease or symptom for which the
drug is being studied, and responses are compared with those of healthy subjects.
Phase 3, the drug is given to different populations and different dosages and by using the drug in combination with other drugs. In Phase 4, the FDA allows the drug to be marketed and requires monitoring of the drug’s safety and effectiveness.

Question 6

Pharmacokinetics

Answer 6

involves drug movement through the body (i.e., “what the body does to the
drug”)
Specific processes are absorption, distribution, metabolism, and excretion.

Question 7

Pharmacodynamics

Answer 7

involves drug actions on target cells and the resulting alterations in cellular biochemical reactions and functions (i.e., “what the drug does to the body”).

Question 8

Schedule I Drugs

Answer 8

Drugs that have no accepted medical use, have lack of accepted safety, and have high abuse potentials: heroin, lysergic acid diethylamide (LSD), 3,4methylenedioxymethamphetamine (MDMA or ecstasy), mescaline, and peyote

Question 9

Schedule II Drugs

Answer 9

Drugs that are used medically and have high abuse potentials: opioid analgesics.
(e.g., codeine, hydromorphone, methadone, meperidine, morphine, oxycodone), central nervous system (CNS) stimulants (e.g., cocaine, methamphetamine), and barbiturate sedative–
hypnotics (e.g., pentobarbital).

Question 10

Schedule III Drugs

Answer 10

Drugs with less potential for abuse than those in Schedules I and II, but abuse of which may lead to psychological or physical dependence: androgens and anabolic steroids, some depressants (e.g., ketamine, pentobarbital), some CNS stimulants (e.g., methylphenidate),
and mixtures containing small amounts of controlled substances (e.g., codeine, barbiturates not listed in other schedules). These drugs and substances have an accepted medical use in the United States.

Question 11

Schedule IV Drugs

Answer 11

Drugs with an accepted medical use in the United States but with some potential for abuse: benzodiazepines (e.g., diazepam, lorazepam), other sedative–hypnotics (e.g., phenobarbital,

Question 12

Schedule V Drugs

Answer 12

Products containing moderate amounts of controlled substances.
-dispensed by the pharmacist without a physician’s prescription but with some restrictions regarding amount.
Included are cough suppressants containing small amounts of codeine and antidiarrheal drugs, such as diphenoxylate and
atropine (Lomotil).

Question 13

Medication oversight in Hospitals

Answer 13

Procurement, preparation, storage, distribution, and control of all drugs throughout a hospital is the responsibility of the Director of Pharmacy.
Medications shall be stored in hospitals in a secure manner to protect public health and safety, and to
promote patient care.

Question 14

The generic name

Answer 14

(Official Name) is related to the chemical or official name and is independent of the manufacturer. The generic name often indicates the drug group (e.g., drugs with generic names ending in “cillin” are penicillins). The generic name often indicates the drug group (e.g., drugs with generic names ending in “cillin” are penicillins).
- Generic drugs are required to be therapeutically equivalent and are less expensive than trade-named drugs.

Question 15

The brand Name

Answer 15

(trade) name is designated and patented by the manufacturer. For example, amoxicillin is manufactured by several pharmaceutical companies, some of which assign a specific trade name (e.g., Amoxil, Larotid) and several of which use only the generic name. In drug literature, trade names are capitalized, and generic names are presented in lowercase.

Question 16

How do we warn patients about drugs

Answer 16

Adverse Effects and
Black Box Warnings

Question 17

Patient Drug Rights

Answer 17

RIGHT DRUG
RIGHT DOSE
RIGHT PATIENT
RIGHT ROUTE
RIGHT TIME
right reason,
right documentation,
right patient education,
right evaluation
right to refuse the medication

Question 18

half-life

Answer 18

Serum half-life, also called elimination half-life, is the time required for the serum concentration of a drug to decrease by 50%.
It is determined primarily by the drug’s rates of
metabolism and excretion. A drug with a short half-life requires more frequent administration than one with a long half-life.

Question 19

steady-state concentrations

Answer 19

When a drug is given at a stable dose, four or five half-lives are required to achieve steady-state concentrations and to develop equilibrium between tissue and serum concentrations. Because
maximal therapeutic effects do not occur until equilibrium is established, some drugs are not fully effective for days or weeks. To maintain steady-state conditions, the amount of drug given must equal the amount eliminated from the body.

Question 20

Absorption

Answer 20

The process that occurs from the time a drug enters the body to the time it enters the
bloodstream to be circulated. Onset of drug action is largely determined by the rate of absorption; intensity is determined by the extent of absorption. Numerous factors affect the rate and extent of drug absorption, including dosage form, route of administration, blood flow to the site of administration, GI function, the presence of food or other drugs, and other variables.

Question 21

Distribution

Answer 21

transport of drug molecules within the body; after a drug is injected or absorbed into the bloodstream, it is carried by the blood and tissue fluids to its sites of action, metabolism, and excretion

Question 22

Metabolism

Answer 22

or biotransformation, is the method by which drugs are inactivated or biotransformed by the body. Most often, an active drug is changed into inactive metabolites, which are then excreted.

Question 23

Excretion

Answer 23

elimination of a drug from the body; effective excretion requires adequate functioning of the circulatory system and of the organs of excretion (kidneys, bowel, lungs, and skin)

Question 24

older adults (65 years and older), physiologic changes may alter all pharmacokinetic processes.

Answer 24

Changes in the GI tract include decreased gastric acidity, decreased blood flow, and decreased motility. Despite these changes, however, there is little difference in drug absorption.
-Changes in
the cardiovascular system
include decreased cardiac output and therefore slower distribution.
-In the LIVER, blood flow and
metabolizing enzymes are decreased. -Drugs are metabolized more slowly, have a longer action, and are more likely to accumulate with chronic administration.
In the KIDNEYS-
decreased blood flow, decreased glomerular filtration rate, and decreased tubular secretion of drugs. Slow excretion and promote accumulation of drugs in the body.

Question 25

Narcan

Answer 25

An antidote drug, which can be given to antagonize the toxic effects of another drug. For example, naloxone is commonly used to relieve respiratory depression caused by morphine and related drugs. Naloxone molecules displace morphine molecules from their receptor sites on nerve cells in the brain so that the morphine molecules cannot continue to exert their depressant effects.

Question 26

Who gives Meds

Answer 26

Registered and licensed practical nurses are legally empowered, under state nurse practice acts, to give medications ordered by licensed physicians, nurse practitioners, physician assistants, and dentists.

Question 27

Nurse Legal Responsibility with Meds

Answer 27

the nurse is legally responsible for safe and accurate administration.
This means that the nurse may be held liable for not giving a drug or for giving a wrong drug or a wrong dose. The nurse is expected to have sufficient drug knowledge to recognize and question erroneous orders. If the nurse considers that giving a drug is unsafe, the nurse must refuse to give the drug.

Question 28

BEERS Criteria List

Answer 28

It provides clinicians with the names of medications that are potentially inappropriate
for use in older adults, listing drugs to be avoided and giving adjustments in dosages related to
chronic kidney disease and diminished kidney function.

Question 29

Drugs that contribute to or produce adverse effects in older adults include the following:

Answer 29

• Amiodarone (Nexterone, Pacerone): altered QT interval
• Amitriptyline hydrochloride: anticholinergic effects and sedation
• Cyclobenzaprine (Amrix): anticholinergic effects and weakness
  -extromethorphan/quinidine: limited efficacy and increased risk of falls
• Digoxin (Lanoxin): digoxin toxicity
• Diphenhydramine hydrochloride: urinary retention
• Flurazepam hydrochloride: sedation
• Hydroxyzine hydrochloride: confusion and sedation
• Ketorolac: gastrointestinal bleeding
• Meperidine hydrochloride (Demerol): confusion
• Methocarbamol (Robaxin): anticholinergic effects and weakness
• Methyldopa: bradycardia and depression
• Nitrofurantoin (Macrodantin): renal toxicity
• Opioids with benzodiazepines and gabapentinoids: central nervous system (CNS) adverse effects
  and potential death
• Rivaroxaban: caution required in patients older than age 75, increased risk of bleeding
• Serotonin–norepinephrine reuptake inhibitors: avoid in patients who have experienced
  fractures or prone to falls
• Trimethoprim–sulfamethoxazole used with angiotensin-converting enzyme inhibitors or
  angiotensin receptor blockers: increased risk of hyperkalemia

Question 30

Drug Metabolizing Enzyme

Answer 30

Cytochrome P-450 (CYP) enzymes in the liver metabolize most drugs. Red blood cells, plasma,
kidneys, lungs, and GI mucosa also contain drug-metabolizing enzymes.

Question 31

first-pass effect

Answer 31

presystemic metabolism. When drugs are given orally, they are absorbed from the GI tract and carried to the liver through the portal circulation. Some drugs are extensively metabolized in the liver, with only part of a drug dose reaching the systemic circulation for distribution to sites of action.

Question 32

Colchicine

Answer 32

(Colcrys, Mitigare), the prototype agent for the treatment and prevention of gout, is the most commonly administered antigout medication.
- Colchicine has a narrow therapeutic index. The drug accumulates leading to severe and potentially fatal adverse effects.
- Pharmacokinetics - Colchicine is absorbed rapidly in the GI tract, with a slow onset of action; it reaches its peak in 1 to 2 hours. The drug is metabolized in the liver and has a half-life of 26 to 31 hours. It is primarily eliminated in the feces, with a smaller amount excreted in the urine. Colchicine crosses the placenta and enters the breast milk.
- Use in Children - Colchicine is only administered to children 4 years of age and older to treat familial Mediterranean fever.

Question 33

Nonsteroidal anti-inflammatory drug (NSAID)

Answer 33

medication that inhibits the synthesis of prostaglandins; used to prevent and treat mild to moderate pain and inflammation,
- the mechanism of action of NSAIDs involves the blocking of COX enzymes
- The propionic acid derivatives are NSAIDs that inhibit prostaglandin synthesis in both the central and peripheral nervous systems.
-The prototype is ibuprofen (Motrin, Advil).

Question 34

Acetaminophen

Answer 34

(also called APAP, an abbreviation of N-acetyl-p-aminophenol) is a nonprescription drug commonly used as an aspirin substitute because it does not cause nausea, vomiting, or GI bleeding and it does not interfere with blood clotting. It is equivalent to aspirin in analgesic and antipyretic effects; however, it does not have the anti-inflammatory activity of aspirin.
Action - To reduce fever, acetaminophen acts directly on the hypothalamus to increase vasodilation and sweating. To diminish pain, it acts via an unknown mechanism of action.
-Acetaminophen is usually safe in recommended doses unless liver damage is present or the person is a chronic alcohol abuser.

Question 35

meloxicam

Answer 35

• The prototype is meloxicam (Mobic). - another type of NSAID.
  -COX-1 and COX-2 inhibitor,
• anti-inflammatory, analgesic, and antipyretic effects. It is more selective for COX-2 inhibition in the brain, kidney, ovary, uterus, cartilage, bone, and sites of inflammation.
• treatment of osteoarthritis and rheumatoid arthritis
• Black Box Warning -risk for cardiovascular
  events and GI bleeding.

Question 36

Tylenol Overdose

Answer 36

Acetaminophen can cause fatal liver necrosis in overdose because it forms a metabolite that can destroy liver cells. The hepatotoxic metabolite is formed more rapidly when drug-metabolizing enzymes in the liver have been stimulated by ingestion of alcohol, cigarette smoking, and drugs such as antiseizure medications and others. Thus, patients who consume large quantities of alcohol, smoke, and take antiseizure medications are at high risk for hepatotoxicity with usual therapeutic doses.

Question 37

sildenafil

Answer 37

• The prototype PDE5 inhibitor is sildenafil (Viagra).
  Prescribers commonly order PDE5 inhibitors as the first-line treatment for ED. These drugs do not cause an erection but help maintain the erection resulting from sexual stimuli by enhancing the vasodilatory effect of endogenous nitric oxide, increasing blood flow to the penis.

Question 38

Benign prostatic hypertrophy (BPH)

Answer 38

is benign enlargement of the prostate gland.
- More than 50% of men in their 60s and as many as 90% in their 70s and 80s have some symptoms of BPH.
Part of the male reproductive system, the prostate is normally a walnut-sized gland composed of two lobes enclosed by an outer layer of tissue. This gland produces part of the seminal fluid that nourishes and transports sperm. The prostate is located in front of the rectum and below the bladder, where urine is stored, and it surrounds the urethra, the
canal through which urine passes out of the body.
Steroid Use linked with BPH

Question 39

Polypharmacy

Answer 39

• The treatment of chronic illnesses and associated comorbidities results in polypharmacy, the use
  of multiple medications. The interactions of medications can lead to greater complications and diminished mental status.
• The treatment of chronic illnesses and associated comorbidities results in polypharmacy, the use of multiple medications. The interactions of medications can lead to greater complications and diminished mental status.

Question 40

Testosterone

Answer 40

male sex hormone; secreted by the Leydig cells in the testes.
- Testosterone is normally the only important androgen. This male sex hormone has several effects on body tissues. Certain cells in the testes, called Leydig cells , secrete testosterone in
response to stimulation by luteinizing hormone (LH) from the anterior pituitary gland. The increased production of testosterone results in the changes associated with puberty in the adolescent male. The main functions of testosterone concern the development of male sexual characteristics, reproduction, and metabolism. Testosterone is necessary for normal sperm development.

Question 41

Routes of administration

Answer 41

depend on drug characteristics, patient characteristics, and desired responses. The major routes are oral (by mouth), parenteral (injected), and topical (applied to skin or mucous membrane). Each has advantages, disadvantages, indications for use, and specific techniques of administration. Common parenteral routes are subcutaneous (Sub-Q), IM, and IV injections. Injections require special drug preparations, equipment, and techniques.

Question 42

Finasteride

Answer 42

(Proscar), the prototype 5-alpha reductase inhibitor, represents this drug class and is used to treat BPH.
- Use - Prescribers order finasteride mainly to treat BPH. However, the drug is also available in smaller doses as Propecia, which is indicated for the prevention of male pattern baldness.

Question 43

Acetylsalicylic acid (ASA)

Answer 43

also know as ASPIRIN, is a nonsteroidal anti- inflammatory drug
(NSAID) used to reduce pain, fever, and/or inflammation, and as an antithrombotic

Question 44

Tamsulosin

Answer 44

used by men to treat the symptoms of an enlarged prostate (benign prostatic
hyperplasia-BPH). Tamsulosin is a medication that relaxes the muscles in the prostate and bladder to treat the symptoms of an enlarged prostate (BPH).

Question 45

Anabolic steroids

Answer 45

synthetic drugs with increased anabolic activity and decreased androgenic activity compared with endogenous testosterone..

Question 46

Reye’s syndrome,

Answer 46

A rare but serious condition that causes swelling in the liver and brain.
-usually affects children and teenagers after a viral infection, most commonly the flu or chickenpox.
- Symptoms - confusion, seizures and loss of consciousness need emergency treatment.
Early diagnosis and treatment of Reye’s syndrome can save a child’s life.
-Has been Linking to ASPIRIN, so use caution when giving aspirin to children or teenagers for fever or pain. Though aspirin is approved for use in children older than age 3, children and teenagers recovering from chickenpox or flu-like symptoms should never take aspirin.