Chapter 4: Regulations Flashcards
Addiction
a substance that encourages dependence on it
Chemical name
drug name that reflects the chemical makeup of the drug
Clinical trials
scientific tests that research the efficacy and safety of a medication
Compassionate use
the use of an investigational new drug (IND) in patients who are suffering greatly and may die without the drug
Control group
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
Controlled Substances
Act
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
Double-blind
neither the patient nor the researcher in the clinical trial knows who has the placebo and who has the drug being tested
DEA
Drug Enforcement Agency of the Department of Justice
FDA
Food and Drug Administration
Generic name
official name of the drug; nonproprietary
IND
Investigational New Drug
NDA
New drug application
OSHA
Occupational Safety and Health Administration
Patent medicine
remedy of questionable value that may harm the patient
Placebo
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
Substance abuse
misuse or improper use of medications
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?
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.
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?
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.
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?
If research is conducted in a scientific manner, countries can cooperate and exchange information— saving the cost of duplicating research.
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
- 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
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?
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.
The DEA approves drugs for dispensing in the United States.
False; FDA approves drugs for dispensing in the United States.
Schedule II drugs are highly addictive
True; Schedule II drugs have a high potential for physical and psychological addiction.
OHSA is part of the Department of Health and Human Services.
False; OSHA is a branch of the Department of Labor.
MedWatch is a way of reporting adverse reactions.
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.
The DEA is a part of the Department of Justice.
True; the DEA is a part of the Department of Justice.
Clinical trials in drug development have two phases.
False; there are four phases in the clinical trials of
drugs
Phase IV clinical trials happen after the drug is released to the public.
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.
In a double-blind clinical trial, neither patients nor clinicians know who is receiving a drug or a placebo
True; in a double-blind study, neither the participant nor the clinician knows who is receiving the active drug.
Generic drugs are trademark protected.
False; only trade or brand names are trademark protected.
The drug suffix -cillin is closely associated with antibiotics.
True; medications with the suffix -cillin usually belong to the antibiotic class.
- The governmental department that enforces the Controlled Substances Act:
A. DEA B. DOJ C. FDA
D. DHHS E. OSHA
A. The DEA is the agency responsible for regulating all of the laws in regards to controlled substances.
- 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
B. A new medication is known as an investigational new drug during the first three phases of clinical trials.
- 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
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.
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
A.
Schedule I drugs are the most addictive and have no accepted medical use.
- An example of a Schedule II drug is:
A. Heroin B. Valium C. Tylenol with codeine
D. Cocaine
D.
Cocaine is a Schedule II drug.
- 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
C. Any controlled substance should be disposed of by destroying it in the presence of a witness.
- What schedule includes anabolic steroids?
A. Schedule I B. Schedule II C. Schedule III
D. Schedule IV E. Schedule V
C.
Anabolic steroids are Schedule III drugs.
- Symptoms of substance abuse include:
A. Tremors B. Poor judgment C. Slurred speech
D. Change in behavior E. All of the above
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.
- 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
D. OSHA mandates that employers provide yearly safety training to all employees, provide protective supplies to all employees, and report all occupational injuries.
- 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
A. The Orphan Drug Act helps with more timely development of drugs for rare diseases.
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?
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.
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?
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?
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?
You should notify the physician and the office manager. After determining that it is truly missing, the police should be notified.
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?
After providing care to the patient, you should fill out an incident report for your agency and submit a MedWatch report to the FDA.
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?
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.
