Pharmacology Assignment 1 Nursing Research

Pharmacology Assignment One

Administering medications is an important and common task done by Nurses. It is crucial that Nurses know how to do so in an appropriate manner to promote the safety of both themselves and their patients. The United States Food and Drug Administration (FDA) website offers current information on safety that can support the professional practice of a Nurse.

Question One

A warning letter is sent to a manufacture if the FDA believes the manufacture has violated FDA regulations (U.S. Food and Drug Administration, 2017). The letter states the error the manufacture has made and informs the manufacture that the problem must be corrected. The FDA must be notified on when and how the problem will be resolved: After the time

Food and Drug Administration, 2017). In addition, the FDA regularly assesses and samples drugs produced in domestic and foreign drug manufacturing plants, as well as retail stores to ensure manufactures are following the laws. FDA also considers complaints made by patients and health care personnel regarding products during its surveillance (U.S. Food and Drug Administration, 2017).

This information informs Nurses of the measures taken by the FDA to ensure patients are given safe medications. It also ensures Nurses that they, and their patients can file complaints about medications to the FDA and that the FDA will review these complaints when assessing those medications.

Question Three

The FDA requires drug manufacturers to follow Current Good Manufacturing Practice regulations (CGMPs) to prevent the contamination of drugs (U.S. Food and Drug Administration, 2017). If contamination occurs during the production of a drug, the FDA requires the manufacturing company to stop the production of the drugs until corrections have been made. If it is found that contamination has occurred after the distribution of a drug, the manufacturing company is mandated to recall the items and perform a thorough investigation. Meanwhile the FDA requires the company to inhibit shipments of the goods and may obtain samples to find the contamination

They discuss Risk Evaluation and Mitigation Strategies (REMS), which is special monitoring for patients using certain drugs (Karwoski, Bough, Colonna, & Gorski, 2012). For REMS to be an effective program, a patient, Physician, Pharmacist and Registered Nurse are needed. REMS allow for certain medication to be used that would otherwise not be allowed.

Dr. Todd Colonna starts off the discussion by discussing REMS programs used by Physicians, such as iPLEDGE, to track patients’ responses to medications (Karwoski et al., 2012). He explains iPLEDGE works by having Doctors and Pharmacists register under Its computerized system. Nurses then register under a Physician’s name to access data. Dr. Colonna states his job as a Medical Doctor is to talk about the risks and benefits of drugs to his clients and inform them of the iPLEDGE program if their potential medication requires such monitoring (Karwoski et al.,