The Important Things

With my research project, I hope that I will be able to answer a few questions:

1. Why it is important that we know if Tamiflu is safe to use during pregnancy

2. Does Tamiflu affects the baby and, if so, how it will effect the child right after birth and in the long run

3. Does Tamiflu protect the growing fetus from the flu virus and how well does it protect the child

There are many other questions that I would like to research but I will remain focused on these three things. I will likely integrate more questions along the way but they will all have something to do with these three questions.

The Problem with Pregnancy

To perform a research study, there are rules that a research team much follow according to regulations by the International Review Board (IRB). The IRB reviews the methods and protocols of a research project that involves human subjects to ensure that the rights of the individual are protected and no unnecessary harm occurs. The problem with pregnancy is that it is generally considered unethical to run research tests during the gestational period. This makes finding well controlled trials in pregnant women difficult. Due to this complication in research, I am exploring a source of information that I have never used before. I was advised by a clinical faculty member to contact the drug manufactures of Tamiflu and ask for all of the research information they have on its use in pregnancy. This is a new avenue for me and I am excited to see how it turns out. I hope that it will broaden my horizons and provide another resource to use in my future career.

And So it Begins

I have finally begun reviewing the literature for my review topic. Though I am excited to start this new challenge, I have found that in each new step one obstacle becomes easier and another new, more difficult obstacle comes up. My obstacle tonight was a lack of motivation and feeling overwhelmed. I guess it is true that if the path to success were a strait line, everyone would be successful.

So What’s the Difference

In my last post, I discussed pregnancy categories and how they are defined. The difficulty with using these pregnancy categories is that they are not all black and white with clear, defined features. When looking at category D and category X drugs, both have shown evidence of fetal damage in animals and humans; however, category D medications can be used when the benefits out weigh the risks while category X medications should never be used. There are no clear cut rules that define what would constitute a benefit that out weighs a risk of the medication and, for me, this makes it difficult to understand the difference between the two categories. How was it decided that one medication should be a category D over category X? Are there alternative therapies that are safer or was a drug placed in category D because there are currently no other available options for treatment? Is it a life-saving treatment?

The use of letters to denote a category also makes me view the categories hierarchically, where A represents the safest medications and the safety profile drops with each drop in letter, but this is not entirely correct. For example, category C medications represent a group of medications where there is not enough evidence to suggest harm or safety. At this point, we do not know if the medication will show damage to the fetus or not. So we really do not know if it is safer to use than a category D or X drug but we also do not know if it is more harmful than a category A or B drugs, yet it is placed in the middle just to confuse me. Category B drugs can have positive evidence for safety in animals and not enough evidence in humans or there were adverse effects seen in animals studies but human data has not shown adverse effects. Why did we see harm in animal studies but it appears that there is no harm in humans? Can evidence of safety in animals correlate to evidence of safety in humans if you can have evidence of harm in animals but evidence of safety in humans?

Category A medications are those that have not been shown to cause harm in the first trimester nor have they shown harm in later trimesters. I feel as though this category should be really straight forward but it is not for me. These are medications that have not shown harm but this does not mean that there is 0 potential for harm.

It is important to note that a lack of evidence does not suggest safety or harm and should not be viewed in a positive or a negative way. A lack of evidence should be treated for what it is, a lack of evidence.

Pregnancy Categories

The use of medications during pregnancy is always difficult due to the potential risks a medication may pose to the growing fetus. Pregnancy categories are used to define the safety of a medication during pregnancy but it is important to note a medication may have different categories during different trimesters.

Pregnancy Categories:

A-Adequate, well-controlled studies have shown the medication is safe for use in the first trimester of pregnancy and has not show problems in later trimesters. This means that the medication has not shown evidence to be of damage to the fetus.

B- Animal studies have not show a risk to the fetus but there is not enough information in human studies or there were adverse effects in animal studies but there were no adverse effects seen in well-controlled human studies

C- Indicates there is not enough information in human and animal studies or there were adverse effects in animal studies but there is no enough human data available. Potential benefits of the drug may warrant its use in pregnant women.

D-There is evidence of fetal risk in both human and animal studies but if the benefits out-weigh the risks, the medication may be considered.

X-There is evidence of fetal risk in both human and animal studies. These drugs should not be considered for use in any pregnant female.

In the Beginning: Tamiflu and Pregnancy

In my last blog post, I announced that I will begin a project in the field of pharmacy. My current topic of choice is The Safety of Tamiflu use During Pregnancy. I am very excited to begin work on this subject and I hope that I will be able to write a review that will be able to describe the safety of Tamiflu through all stages of pregnancy! My decision to choose this subject was due to failing an assignment in which it was intended that I provide a hypothetical patient with Tamiflu (spoiler, I did not give the patient Tamiflu). After viewing arguments for the use of Tamiflu, I became curious about the pros verses cons in pregnancy. With this project, I intend to compare these pros and cons in pregnancy.

The Start of Something New

Hello, my name is Maddie Carlson.  I am currently a student at South University School of Pharmacy in Savannah, GA.  My final didactic quarter has just started and I have been prompted to begin a blog that follows my journey through writing my manuscript. My hope, through this blog, is to present new information in the field of pharmacy relating to my manuscript subject and to grow as a writer. I am still waiting on approval for my subject but I will begin in depth research soon. I hope you will join me on this course!