Why write a monograph?

[NormalSaline]

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I have an assignment this semester to write a drug monograph. I have also heard mention of writing monographs in drug info practice/residency settings.

Why would one write a monograph when the manufacturer, clinical pharmacology and countless other databases etc etc have already written monographs?

I understand it is a good learning experience for pharmacy students. I want to know why this is done, especially why one would do this in a practice environment?

 

[WVUPharm2007]

Because some professors/preceptors have no idea how to teach you anything. They think busy work is learning. Busy work is just something to get you out of their hair and/or to allow them to present the facade of actually teaching. I'd just roll my eyes and do it. If there's one thing I've learned...don't 'f around with people in academia. They will crush you with all of their might...just because they can.

 

[bigpharmD]

I have an assignment this semester to write a drug monograph. I have also heard mention of writing monographs in drug info practice/residency settings.

Why would one write a monograph when the manufacturer, clinical pharmacology and countless other databases etc etc have already written monographs?

I understand it is a good learning experience for pharmacy students. I want to know why this is done, especially why one would do this in a practice environment?

Drug info or residency or monographs written for pharmacy departments are done so to give P and T info so they can decide if it should be added to formulary. These include info on studies comparing similar products etc on formulary. At the end based on all the info you give a rec. It should not just be copied and pasted from the insert. You can use some of the info but it should be concise and to the point. The key is to analyze the literature and decide if this drug is better than the ones that are already offered on formulary. The people on p and t include nurses, id physicians, nephrologists, surgeons and others who might have no clue what the drug is. For example, look at tekturna. Should we add it even though there are a 100 ACEs and ARBs with better studies and no studies comparing them. Would the id physician be able to tell us why or why not without seeing the monograph?....

 

[ItsOverZyvox]

Manufacturer provides a PI not a monograph. Clinical Pharmacology is ok but many times it's not tailored to your hospital. A monograph serves a purpose. It educates the hospital staff and provides an opportunity toreview the class of medication the new drug is in. It also allows for a review of the formulary. A hospital specific monograph should contain formulary and cost information. Also, it should include a review of different clinical trials pertaining to the new drug and the drugs in the same class. And most importantly, it should contain a position statement on if it should be added to the formulary or not.

If you're going into retail, this isn't so important to know how to write a monograph. But in a clinical setting, you should know how to do this in your sleep.

 

[NormalSaline]

don't 'f around with people in academia. They will crush you with all of their might...just because they can.

I'm definitely not trying not to complain or go against the grain here. I'm just trying to find justification for all this time I'm spending.

To the other responders: That stuff actually sounds pretty cool. Shoot, I'd love to be able to dive into lit and determine practical drug info or formulate an opinion on its merits.

This assignment is actually for my drug lit review class.... but it hasnt been explained to us very well.... Even the example were given only lists CP and Lexicomp etc as sources

I'm sure I'll understand better at the end of the semester.

Thanks.

 

[njac]

I just did a tox based monograph on benzonatate. It wasn't hard per se (you'd think a drug that old would have more written about it) but now the SPIs have a consolidated document of what's available - case reports and off label uses not noted in the skeletal package insert.

That's why we had to do them on this rotation anyway.

 

[NormalSaline]

I just did a tox based monograph on benzonatate. It wasn't hard per se (you'd think a drug that old would have more written about it) but now the SPIs have a consolidated document of what's available - case reports and off label uses not noted in the skeletal package insert.

That's why we had to do them on this rotation anyway.

Whats SPI?

 

[njac]

Specialist in poison info. I'm on a clin tox rotation at a poison center - those are the people who answer and handle calls

 

[117296]

Manufacturer provides a PI not a monograph. Clinical Pharmacology is ok but many times it's not tailored to your hospital. A monograph serves a purpose. It educates the hospital staff and provides an opportunity toreview the class of medication the new drug is in. It also allows for a review of the formulary. A hospital specific monograph should contain formulary and cost information. Also, it should include a review of different clinical trials pertaining to the new drug and the drugs in the same class. And most importantly, it should contain a position statement on if it should be added to the formulary or not.

If you're going into retail, this isn't so important to know how to write a monograph. But in a clinical setting, you should know how to do this in your sleep.

QFT.

The P&T looks for:
-Is this drug safer than other drugs in its class? (Would it result in fewer med errors or does it have lower AE's?)
-Does this drug work better than others in it's class (Does it have a higher efficacy?)
-Is the drug unique in some way (Only drug in its class, etc.)
-All other things being equal, does it have a lower cost?

Take info from lit searches, Micromedex AND Clin pharm (it's different sometimes), package inserts, and whatever cost information you can get. Presenting the information in a clear, coherent, easy to read way is often the hardest part.

 

[Hels2007]

As the others have said above, drug monographs are quite useful for P&T purposes. However, the way the assignment is often handled in pharmacy school, it is devoid of all meaningful effort/content, and is mind-numbingly boring. Oh wait, I actually think all drug info is mind-numbingly boring, but that's beside the point. When I was in school, our drug lit monograph writing was literally copy-pasting from the package insert... or doing the stupid table with the number of patients in each clinical trial described in the label... I am glad I don't have to do anything like that anymore.

 

[ItsOverZyvox]

The most important reason? Cuz I don't have time to and students and residents should be abused.