Question

A drug company is beginning a new drug trial for a medication that is used to treat rheumatoid arthritis (RA). Jonna is a 22-year-old female who has had RA for 2 years and does not feel that she has full relief of pain from the medications she has taken. She states she has fallen on hard times since she became ill and the money for the study will also be beneficial. She wants to participate in the study.

1. Discuss the reason she should not participate in the study. Do you feel this patient should be allowed to participate?
2. Discuss the role of the Food and Drug Administration (FDA) in clinical drug testing.
3. In order to safely administer medications, all nurses must understand how to read a drug label. Discuss the information that is found on a drug label.
4. The nurse is administering a drug and recognizes it as a controlled substance. The prescription, distribution, storage, and use of controlled substances are closely monitored by the DEA in an attempt to decrease substance abuse of prescribed medications.

Answer 1

Ans) Part A: Jonna should not participate in the studies because :

​​​​​​​​A) It's symptoms include pain and swelling.

B) It is more activated during the day time.

C) Usually cause tingling or burning sensation in the joints.

So Jonna should not be allowed to participate in the studies because she is a young in age and this trial could lead her life in trouble because this medication is not tested or successful.

But if she really wants to participate in testing, written consent should be given by her that she would be responsible for any adverse consequence.

Part B: Role of FDA in drug testing-

1) Ensure safety and efficacy of human beings.

2) For providing reliable information.

3) They take case of all the criterias including age, sex, type and stage of diseases.

Information found on Drug Label :

1) Dietary Supplements

2) Over the counter meficines

3) Patient's name

4) Name of the medicine

5) Dosage and instructions on how to take the medicines

6) Critical medicines should be provided only after doctor's prescription

Role of Nurse : ​​​​​​​Nurse should have adequate knowledge regarding the drug administration. prescription, distribution, storage and preparation of all the substances must be performed under expertize nurse to control drug abuse.