Chapter 4: Regulations

Question 1

Addiction

Answer 1

a substance that encourages dependence on it

Question 2

Chemical name

Answer 2

drug name that reflects the chemical makeup of the drug

Question 3

Clinical trials

Answer 3

scientific tests that research the efficacy and safety of a medication

Question 4

Compassionate use

Answer 4

the use of an investigational new drug (IND) in patients who are suffering greatly and may die without the drug

Question 5

Control group

Answer 5

group of people in clinical trials who receive the placebo or usual treatment, in contrast to the group given the treatment or medication being studied

Question 6

Controlled Substances

Act

Answer 6

substances monitored under the Comprehensive Drug Abuse Prevention and Control Act, a law enacted in 1971 to control the distribution and use of all depressant and stimulant drugs and other drugs of abuse or potential abuse as may be designated by the Drug Enforcement Administration of the Department of Justice

Question 7

Double-blind

Answer 7

neither the patient nor the researcher in the clinical trial knows who has the placebo and who has the drug being tested

Question 8

DEA

Answer 8

Drug Enforcement Agency of the Department of Justice

Question 9

FDA

Answer 9

Food and Drug Administration

Question 10

Generic name

Answer 10

official name of the drug; nonproprietary

Question 11

IND

Answer 11

Investigational New Drug

Question 12

NDA

Answer 12

New drug application

Question 13

OSHA

Answer 13

Occupational Safety and Health Administration

Question 14

Patent medicine

Answer 14

remedy of questionable value that may harm the patient

Question 15

Placebo

Answer 15

inactive substance given to satisfy a patient’s demand for medicine; a drug or treatment used as a nonspecific or inactive control in a test of a therapy that is suspected of being useful for a particular disease or condition

Question 16

Substance abuse

Answer 16

misuse or improper use of medications

Question 17

Mr. Dupee is upset that he is unable to obtain a drug in the United States. He knows of a website on which he can order the medication from Mexico. What are the potential dangers of ordering a drug from another country? How would you discuss this with him?

Answer 17

The drugs ordered from another country may not be the same as those in America. They are not con- trolled by the FDA. Discuss safety concerns with the patient. Help him access resources if money is an issue.

Question 18

Not all people who volunteer for clinical trials are acceptable for the research. What do you think could disqualify a patient from participating in clinical trials?

Answer 18

The volunteer may have a comorbid condition that excludes participation. Sometimes the researchers are also looking for a mixture of genders, races, and ages, which might eliminate this volunteer. Also, illness, pregnancy, distance from research facility, and lack of interest in participating could impede the trials.

Question 19

Canadians are protected by the Health Protection Branch (HPB) of the Department of Health and Welfare. Why would it be important for countries to cooperate in drug research?

Answer 19

If research is conducted in a scientific manner, countries can cooperate and exchange information— saving the cost of duplicating research.

Question 20

Drug names can reflect their treatment effect. Try to determine what the drugs listed here could be used for and then check a drug reference book to see how close you were.
Azmacourt
Bronkaid
Elimite
Flexeril
Glucotrol
Lipitor
NasalCrom
Nicoderm
Pepcid
Rythmol

Answer 20

• Azmacourt—For asthma
• Bronkaid—For the bronchi
• Elimite—Eliminates mites
• Flexeril—Muscle flexibility
• Glucotrol—Controls blood glucose
• Lipitor—Decreases blood lipids
• NasalCrom—Works on the nose
• Nicoderm—Nicotine on skin
• Pepcid—Digestive aid
• Rythmol—Heart rhythm

Question 21

A patient calls frequently and begs for more pain medication. The doctor and staff are frustrated by the repeated requests and attribute them to drug- seeking behavior. How would you handle this situation?

Answer 21

The patient may need more information about his or her illness or medications. Perhaps the patient needs a stronger medication or substance abuse counseling. It is important not to indulge the behavior while having empathy for the patient.

Question 22

The DEA approves drugs for dispensing in the United States.

Answer 22

False; FDA approves drugs for dispensing in the United States.

Question 23

Schedule II drugs are highly addictive

Answer 23

True; Schedule II drugs have a high potential for physical and psychological addiction.

Question 24

OHSA is part of the Department of Health and Human Services.

Answer 24

False; OSHA is a branch of the Department of Labor.

Question 25

MedWatch is a way of reporting adverse reactions.

Answer 25

True; MedWatch is a program with the FDA that allows you to report adverse reactions to medication. This program allows for tracking of problems with medications.

Question 26

The DEA is a part of the Department of Justice.

Answer 26

True; the DEA is a part of the Department of Justice.

Question 27

Clinical trials in drug development have two phases.

Answer 27

False; there are four phases in the clinical trials of | drugs

Question 28

Phase IV clinical trials happen after the drug is released to the public.

Answer 28

True; phase IV is also known as the post- marketing phase and includes surveillance for any problems not previously identified through the MedWatch program or additional research.

Question 29

In a double-blind clinical trial, neither patients nor clinicians know who is receiving a drug or a placebo

Answer 29

True; in a double-blind study, neither the participant nor the clinician knows who is receiving the active drug.

Question 30

Generic drugs are trademark protected.

Answer 30

False; only trade or brand names are trademark protected.

Question 31

The drug suffix -cillin is closely associated with antibiotics.

Answer 31

True; medications with the suffix -cillin usually belong to the antibiotic class.

Question 32

1. The governmental department that enforces the Controlled Substances Act: A. DEA B. DOJ C. FDA D. DHHS E. OSHA

Answer 32

A. The DEA is the agency responsible for regulating all of the laws in regards to controlled substances.

Question 33

2. During the first three phases of clinical trials, a drugs is known as a/an: A. Experimental new drug B. Investigational new drug C. Orphan drug D. Generic drug E. Chemical drug

Answer 33

B. A new medication is known as an investigational new drug during the first three phases of clinical trials.

Question 34

3. Once a drug clears the first three phases of clinical trials, it is given a name: A. Generic B. Trade C. Brand D. Chemical E. B or C

Answer 34

E. A brand (trade) name is given to a drug by its manufacturer after the first three phases of clinical trials have been completed successfully.

Question 35

The most addictive schedule of drugs, with no accepted medical use, is ______ drugs: A. Schedule I B. Schedule II C. Schedule III D. Schedule IV E. Schedule V

Answer 35

A. | Schedule I drugs are the most addictive and have no accepted medical use.

Question 36

5. An example of a Schedule II drug is: A. Heroin B. Valium C. Tylenol with codeine D. Cocaine

Answer 36

D. | Cocaine is a Schedule II drug.

Question 37

6. A damaged controlled substance should be disposed by: A. Flushing it down the toilet B. Throwing it in the garbage C. Destroying it beyond any possible use in the presence of a witness D. None of the above

Answer 37

C. Any controlled substance should be disposed of by destroying it in the presence of a witness.

Question 38

7. What schedule includes anabolic steroids? A. Schedule I B. Schedule II C. Schedule III D. Schedule IV E. Schedule V

Answer 38

C. | Anabolic steroids are Schedule III drugs.

Question 39

8. Symptoms of substance abuse include: A. Tremors B. Poor judgment C. Slurred speech D. Change in behavior E. All of the above

Answer 39

E. Symptoms of substance abuse include tremors, poor judgment, slurred speech, changes in sleep habits, excessive weight change, excessive sweating, poor coordination, needle marks, poor work performance, moodiness, restlessness, irritability, violent temper outbursts, and forgetfulness.

Question 40

9. OSHA mandates that employers: A. Provide yearly safety training to all employees B. Provide protective supplies to employees C. Report all occupational injuries D. All of the above

Answer 40

D. OSHA mandates that employers provide yearly safety training to all employees, provide protective supplies to all employees, and report all occupational injuries.

Question 41

10. The Orphan Drug Act: A. Facilitates the development of drugs for rare diseases B. Facilitates the development of drugs for children C. Facilitates the development of drugs for almost eradicated diseases D. None of the above

Answer 41

A. The Orphan Drug Act helps with more timely development of drugs for rare diseases.

Question 42

You just started a new job in Dr. Johnson’s office. When you ask about safety needles for injections, you are told that the office is using nonsafety needles. Is this a problem? What would you do?

Answer 42

Yes this is a problem. All agencies are required by law to provide safety devices to employees. You should talk to your employer about the need for these safety needles, for both employee and patient safety. If the employer refuses to obtain them, this is an OSHA violation.

Question 43

You have a patient diagnosed with a rare form of leukemia. She is thinking of entering clinical trials for a new drug and wants your opinion. What would you say to her?

Answer 43

You should refer this patient to the physician to discuss the prognosis of her leukemia and the pros and cons of treatment in a clinical study. Is there a possibility that she will receive placebos and thus not receive treatment?

Question 44

At the end of the day, you are counting the scheduled drugs in the locked cabinet and discover that an entire box of morphine is missing. What do you do?

Answer 44

You should notify the physician and the office manager. After determining that it is truly missing, the police should be notified.

Question 45

You are administering an antibiotic injection to a patient. Five minutes after the injection, he has a grand mal seizure. The patient has never had a seizure before, and the physician thinks it may be related to the medication. What do you do, and to whom do you report this?

Answer 45

After providing care to the patient, you should fill out an incident report for your agency and submit a MedWatch report to the FDA.

Question 46

You are the office manager in a busy family practice. You have a medical assistant who has incurred a dirty needle stick four times this month. What should you do?

Answer 46

With each needle stick, follow the postexposure protocol. This employee requires further education in proper procedures for needle disposal. If the injuries continue, the employee may need to be terminated.