PharmacologyIndex card topics

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Laws and Legislation This legislation established the USP and

National Formulary. It also required manufacturers of medications to list the contents of the medication A. Food, Drug, and Cosmetic Act of 1938

B. 1962 Kefauver-Harris Amendment of the 1938 Act

C. Orphan Act of 1983

D. Pure Food and Drug Act of 1906

Rationale: The Pure Food and Drug Act of 1906 was the first federal law that protected the public from mislabeling (or in some cases no labeling) of food and drugs. Many elixers contained high concentrations of alcohol, cannibus, and opium.

This law not only applied to drugs, but also to foods and manufacturing of foods ie meat processing plants. Coca- Cola is another example. Did you know that Coca- Cola contained high levels of cocaine? The company switched to caffeine in the early 1900s as a result of this regulation.

Laws and Legislation What is the significance of the Kefauver-

Harris Amendment of the 1938 Act? A. It created the DEA

B. It provided funding to research drugs used to treat diseases that affected only a small percentage of the population

C. It required that drugs be tested for safety, effectiveness and quality prior to marketing and distribution

D. It differentiated between prescription and non prescription drugs

Kefauver-Harris

AmendmentThe Kefauver- Harris Amendment required

pharmaceutical companies to test for safety, efficacy and

quality. This amendment was spurred by the Thalidomide

tragedy in Europe. Thalidomide was marketed as an anti-nausea drug and given to many pregnant women for

morning sickness. The drug did provide relief, however, it also

caused significant birth defects.

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Laws and Legislation The significance of the 1970 Controlled

Substance Act is that it: A. Require manufacturers to disclose addictive

substances included in ingredients

B. Created designation of schedules or categories of mind altering substances

C. Required companies to give information for off-label drugs

D. Required companies to wait for FDA approval prior to marketing the drug

The controlled substance act of 1970 also provided for the following: Increased research and education for

prevention of drug dependence

Strengthened enforcement authority over prescribing, manufacturing and regulating of drugs

Designated schedules or categories of controlled drugs

Created the drug enforcement agency (DEA)

Which regulatory agency is responsible for creating health policies within the United States? A. The CDC

B. The DEA

C. The FDA

D. The ANA

The FDA regulates drugs, foods, and medical equipment

The DEA enforces controlled substance laws

The ANA sets the national standards of practice for nurses

The state board of nursing sets the standards for nursing in each state

Half Life Morphine has a ½ life of 2 hours. Mr. Smith

receives Morphine 4 mg at 8:00am. Based on the drug half life, how many mg would you estimate to be in Mrs. Smith’s system at 10:00 am? 2 mg

How many mg would you estimate at 12:00 noon? 1 mg

Half Life Mr. Smith’s pain medication is switched to

Tylenol 325 mg po (by mouth) every 4 hours. The half life of Tylenol is 4 hours. If Tylenol 325 mg is given at 8:00 am, what is the half life for the given times? 12:00 pm

162.5

4:00 pm

81.25

Half Life Mr. Richard takes warfarin (a blood thinner)

which has a half life of 40 hours. Mr. Richard requires a surgical procedure within the next 24 hours. The health care provider orders the warfarin to be held and also orders vitamin K for Mr. Richard. Vitamin K will reverse the effects of warfarin. If the warfarin is being held, why did the healthcare provider order Vitamin K?

Since warfarin has a half life of 40 hours, it will take about 5 days for the medication to wear off and the bleeding times to normalize. For most patients, this time period is too long to wait for surgery. Vitamin K provides a faster reversal of the medication. Consider this- the patient requires a blood thinner to prevent clot formation, so the longer the patient is off of the warfarin the greater the risk of clotting. With vitamin K the reversal is quick.

June is prescribed Lasix, a drug that is acidic in nature, orally once per day. Which statement is true regarding absorption of this oral medication. A. Since the drug is acidic in nature, it will be

better absorbed in the stomach

B. Since the drug is acidic in nature, it will have poor absorption in the stomach

C. Since the drug is acidic in nature, it will be neutralized in the stomach

D. Stomach pH will not affect the absorption of this drug.

Rationale:

This is based on the pH partitioning theory proposed in 1957 by Brodie. The theory explained how the pH in the GI tract and the pKa (acid dissociation constant) affect absorption rates. Put simply, weak acidic drugs absorb faster in an acidic environment (stomach).

You are caring for a male patient who has high blood pressure. The health care provider has ordered an ace inhibitor. You research the medication and find that it is excreted primarily through the kidneys. The patient’s GFR is decreased. The BUN is 27 and the Creatinine is 1.5. Should you be concerned about these lab values? Why?

Yes, you should be concerned. A decreased GFR, an elevated BUN and creatinine all indicate a decrease in kidney function. Since this drug is primarily excreted by the kidney, it is possible that the drug will not be eliminated from the body as it should and if given concurrent doses of this medication the patient could end up with too much of the medication in circulation.

The placental barrier is most effective during the last trimester.

True

False

The placental barrier is a natural barrier that keeps substances from reaching the fetus. It is not the most effective barrier as most drugs will eventually cross over. The placental barrier is strongest during the first two trimesters. During the third trimester the placenta starts to thin and the barrier becomes weaker. The fetus is most at risk during the first and third trimester. The first trimester is risky because this is when all major organ systems are developing and drugs can alter that development. The third trimester is also risky because the barrier is thin and weakened.

The blood brain barrier allows water soluble drugs to pass through the membrane freely.

True

False

The blood brain barrier is very effective and selective. Simple lipid soluble substances (like alcohol) penetrate this lipid rich membrane and are able to pass through the barrier. All other substances need a carrier (an enzyme, a protein, etc). This has made drug development more difficult.

Jane Doe receives an intramuscular injection of an antibiotic. Should the nurse be concerned about first pass effect for this medication?

Yes

No

No

First pass effect only occurs with drugs that are given orally. Oral drugs are absorbed through the GI tract into the blood stream to the portal vein and into the liver. Medications given through a nasogastric feeding tube (tube from the nose to the stomach) or a PEG tube (tube inserted directly into the stomach) are also subject to first pass. First pass effect occurs when the liver metabolizes or deactivates the medication before it gets to the target cell/organ.

What is the end result of first pass effect? A. There will be more drug in circulation

B. There will less drug in circulation

C. The drug will alter the enzyme activity in the liver

D. The drug will accumulate in the liver causing liver damage

First pass effect occurs when the liver metabolizes (deactivates) the medication before it can reach the target organ. Some drugs are completely metabolized, others only partially. The amount depends on the nature of the drug and the health of the liver. The end result of first pass effect is a decreased amount of medication in systemic circulation.

Enterohepatic recirculation may result in longer ___________ time. A. Absorption

B. Distribution

C. Excretion

D. Metabolism

Enterohapatic recirculation affects drugs that are excreted in bile. Enterohepatic recirculation occurs when drugs that are in bile and should be excreted with stool are reabsorbed into the intestinal mucosa then into the blood stream. Eventually the drug will end up in the portal system again then excreted in bile. As a result the medication will stay in the body longer.

Pharmacodynamics is best described as A. How the body affects a drug

B. How the drug affects the body

C. How drugs are broken down into solution

Pharmacodynamics is defined as : the study of the biochemical and physiological effects of drugs and the mechanisms of their actions, including the correlation of their actions and effects with their chemical structure.

Pharmacokinetics includes the mechanisms of absorption, distribution, metabolism and excretion.

Mrs. Jacobs is prescribed Vancomycin (an antibiotic) by her health care provider. The nurse draws blood to check the serum vancomycin peak and trough. What is the rationale for measuring these lab values? A. Vancomycin has a narrow margin of safety

B. Vancomycin has a wide margin of safety

C. Vancomycin has a long half life

D. The patient probably has problems with excretion

Vancomycin has a low therapeutic index. Therapeutic index is calculated during the drug research process. To find the therapeutic index, researchers use a mathematical equation which includes LD50 (which is the dose that caused death in 50% of the animals studied) and ED50 (which is the dose of the drug that is therapeutic in 50% of the population).

A drug with a low therapeutic index has a narrow margin of safety and a higher risk of toxicity.