This assignment is worth 50 points. Good grammar and spelling is expected; point
ID: 127716 • Letter: T
Question
This assignment is worth 50 points. Good grammar and spelling is expected; points will be deducted if they are lacking. Write a short paper of at least 25 sentences on one of the following topics:
1) Epoetin alfa (Procrit/Neupogen) was recently placed into a REMS program by the FDA due to safety concerns in cancer patients. What is a REMS program? What steps/requirements are placed on the dispensing pharmacy?
2) Chemotherapy regimens are often given in cycles with very specific doses on very specific days of the cycle. Why?
3) 20 years ago, we recommended that every household should have a bottle of Syrup of Ipecac in it. It's almost impossible to find now (my drug wholesaler doesn't even stock it). What does Syrup of Ipecac do? Why did it fall out of favor?
Explanation / Answer
1.
A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage a known or potential serious risk associated with a drug or biological product.
A REMS will be required if the Food and Drug Administration (FDA) determines that a REMS is necessary to ensure the benefits of the drug or biological product outweigh its risks. A REMS can include a Medication Guide, Patient Package Insert, a communication plan, elements to assure safe use, and an implementation system. This resource center contains information for pharmacists, patients, and other healthcare professionals about REMS, and the specific requirements for drugs that require a REMS.
Steps/requirements are placed on the dispensing pharmacy-
2.
Chemotherapy kills rapidly-dividing cells in a variety of ways, depending on the drug. Since there are many different types of cancers that all grow differently, many chemotherapy drugs have been developed to target these various growth patterns. Each drug has a different way of working and is effective at a specific time in the life cycle of the cell it targets. For example, some chemotherapy drugs work by:
Chemotherapy treatment is given in cycles. This allows the cancer cells to be attacked at their most vulnerable times, and allows the body's normal cells time to recover from the damage.
A cycle can last one or more days, but is usually one, two, three, or four weeks long. A course of chemotherapy is comprised of multiple cycles. Each course is different, but generally consists of four to six cycles. It may take a relatively short period of time to receive some chemotherapy drugs, while others take hours. It all depends on the treatment regimen that your doctor recommends.
3.
Ipecac is a plant. It is used to make medicine. Ipecac is used in the emergency treatment of certain kinds of poisoning. It is used to cause vomiting of the poison.
. These dosage forms are too strong and may cause serious side effects or death. Only ipecac syrup contains the proper strength of ipecac for treating poisonings.
Ipecac should not be used to cause vomiting as a means of losing weight. If used regularly for this purpose, serious heart problems or even death may occur.
Ipecac fall out of favor because even though it seems to make sense to induce vomiting after the ingestion of a potentially poisonous substance, ipecac was never proven to be effective in preventing poisoning. and research failed to show benefit for children who were treated with it. This was the key reason for the policy change.
It is also important to note that poisoning deaths have dropped dramatically over the last 50 years and that most emergency rooms have stopped using the drug in favor of the more effective activated charcoal. Research has shown that ipecac medication has been improperly administered by parents, and has been abused by people with eating disorders such as bulimia. In rare cases, ipecac was used abusively by parents or caregivers with Munchausen Syndrome By Proxy (a type of child abuse). Abuse of ipecac can lead to heart problems and even death.