Role of the FDA in Clinical Drug Testing
The FDA is responsible for controlling the pharmaceutical industry in the interest of safeguarding public health. The institution is tasked with ensuring that all drugs available in the U.S. market meet a particular standard for efficacy and safety. Drug regulation is essential as it ensures the proper evaluation of potential new treatments.
Counsel to Melanie on Clinical Trials
Nurses have an obligation to counsel participants in clinical trials to ensure they are safe and fully informed on all procedures. As Melanie's nurse, I would encourage her to read and understand everything about clinical trials before giving her consent. I would talk to her about the purpose of the new drug trial for JA and advise her to understand the study's potential benefits and risks. I would also encourage her to ask questions to gain clarity on the process.
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How the DEA Controls Drugs with Abuse Potential
The DEA use a drug scheduling system outlined in the Controlled Substances Act (CSA) to create a rating system to establish which drugs have higher abuse potential. Findings from the scheduling offer clear implication on the manufacture, distribution, importation, possession, and use of these drugs. The drugs with high abuse potential usually have strict guidelines in regards to their medicinal application.
Schedules of Controlled Substances
Controlled substances are comprised of prescription or illegal drugs regulated in the U.S.by the CSA. There are five categories of scheduled drugs. They include:
Schedule I Drugs: A good example is heroin because its potential for abuse is high
Schedule II Drugs – For instance, cocaine. Its potential for abuse is high; however, it has clinical applications
Schedule III Drugs – For instance, benzphetamine . Its potential for abuse is lower than Schedule I and II drugs
Schedule IV Drugs – For instance, mazindol . Its potential for abuse is lower than Schedule III drugs
Schedule V Drugs – For instance, cough medicine with codeine. Its potential for abuse is lower than Schedule IV drugs.
One Way a Nurse would Monitor a Patient Receiving a Controlled Substance
Nurses play an essential role in monitoring patients in clinical trials through the drug development lifecycle. A nurse would monitor a patient receiving a controlled substance through off-site monitoring at regular intervals. This form of monitoring is ideal since it increases trial speed by avoids disruption in the clinical research site.
