pharmagirl

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Does your pharmacy have a system setup to ensure that patients receive a medication guide (for those drugs requiring one) with each new prescription and subsequent refill?

I worked for a pharmacy during school and their software automatically knew to print one out each time they filled for one of the drugs on the list requiring the med guides. Now I work for a place that doesn't have that functionality and we are trying to come up with a way to make sure people are getting this with each fill. How does your pharmacy handle this?

Also, does anyone have a list of the specific drugs that require a med guide? The FDA has a list of available guides but it doesn't say which ones are required and it seems to be missing quite a few from the big required classes like NSAIDs and antidepressants:
http://www.fda.gov/cder/offices/ods/medication_guides.htm








http://drugtopics.modernmedicine.co...dGuides/ArticleStandard/Article/detail/314981

Since 1998, the Food & Drug Administration has had the regulatory authority to require pharmacies to distribute Medication Guides to patients getting certain high-risk drugs. MedGuides, which provide written information to patients on their Rxs, are prepared by drug manufacturers and approved by the FDA. To date, the FDA lists more than 75 drugs on its Web site that require the distribution of a MedGuide from a community pharmacy or upon hospital discharge. They include antidepressants, nonsteroidal anti-inflammatory drugs (NSAIDs), and others. Manufacturers of these high-risk drugs are responsible for ensuring that a sufficient number of MedGuides are available in pharmacies.

Are pharmacists dispensing these critical documents? Are patients getting this needed drug safety information?

Anecdotally, interacting with practicing R.Ph.s, we've heard that MedGuides are not routinely being distributed to patients. To determine if this is the case, we conducted a survey of 21 Pennsylvania community pharmacies identified from the local telephone directory. There were 17 chain, three independent, and one franchise pharmacy, each within a medium-sized municipality. The 17 chain pharmacies were operated by six different corporations.

An undercover patient presented a prescription for celecoxib to these pharmacies between Nov. 30 and Dec. 8, 2005. For economic reasons, the survey was limited to only one NSAID. All written drug information distributed at the time of celecoxib dispensing was collected. The patient purposely did not solicit information on celecoxib from the pharmacy staff. One of the 21 pharmacies intended for inclusion in the study had ceased operation, so the final number of pharmacies surveyed was 20.


Of the 20 pharmacies surveyed, a MedGuide for celecoxib was distributed by only one chain pharmacy (5%). The purpose of the MedGuide was not communicated to the patient. But all 20 pharmacies did distribute to the patient other written drug information about celecoxib, produced by three different commercial information vendors.

A clear limitation of our survey was the small sample size covered. Further study is needed before we can say that our results are projectable to the population at large.

Why did only one pharmacy distribute the MedGuide for celecoxib? We don't know, but here are some possible reasons:

* First, pharmacists may not be aware of the MedGuide regulations for celecoxib and other drugs.
* Second, pharmacists may believe that the written drug information they are distributing, produced by commercial vendors, meets the FDA's regulatory requirements.
* Third, the manufacturer of celecoxib may have failed to ensure that sufficient quantities of the MedGuide are reaching pharmacies for distribution to patients.


Of note is the fact that the drug information produced by one commercial vendor and distributed by two pharmacy chains contained the statement, "Read the Medication Guide provided by your pharmacist before you start using celecoxib and each time you get a refill." Yet no MedGuide was distributed, nor any information concerning the existence of a MedGuide.

What are the consequences to pharmacists who fail to distribute a MedGuide? The MedGuide is part of the drug labeling, and failure to distribute it may be construed as a misbranding violation. There are no provisions in the regulations providing pharmacies with the option to distribute patient leaflets or written drug information produced by commercial vendors as a substitute when a MedGuide is required for a particular drug.

Even if the FDA or state pharmacy boards do not take pharmacies to task for failing to dispense MedGuides as mandated, pharmacists may be liable in another way. Experts believe that patients who did not receive a MedGuide and are injured may have strong grounds to file suit against their pharmacy and win the case.

In light of these legal concerns, we recommend that pharmacies set up a system to remind themselves to distribute this important document. Work with your computer vendor so that each time you dispense one of the 75 drugs involved, your system will alert you to the need to give out a MedGuide.

For more information about MedGuides, check out FDA's Office of Drug Safety Web site at: http://www.fda.gov/cder/Offices/ODS/labeling.htm.
 

Farmercyst

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Not 100%, but the policies are in place and drugs marked in the computer so that the only reason they aren't given is lack of attention given to that policy. Heck we can't even keep the shelves organized.
 

pharmagirl

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Not 100%, but the policies are in place and drugs marked in the computer so that the only reason they aren't given is lack of attention given to that policy. Heck we can't even keep the shelves organized.
So, do they print out automatically or do you have to print them separately?
 
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Farmercyst

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pharmagirl

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Some are kept as hard copies in file folders which are just grabbed before the med is dispensed, others are printed from the FDA website.
http://www.fda.gov/cder/Offices/ODS/medication_guides.htm
That is sort of what we are doing, but it's difficult to make sure they go out when they're supposed to. I think we can make our system pop up a note each time a certain drug is used, so I guess we could flag the reminder that way.

I was hoping there was somewhere that you could buy a bunch of these medication guides on tear-off pads or something along those lines.
 

Hels2007

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That is sort of what we are doing, but it's difficult to make sure they go out when they're supposed to. I think we can make our system pop up a note each time a certain drug is used, so I guess we could flag the reminder that way.

I was hoping there was somewhere that you could buy a bunch of these medication guides on tear-off pads or something along those lines.
I know there are tear-off pads, I am trying to remember where we got them from. Walgreen's also does automatic printouts, but once the normal-paper drawer on the printer broke down and we had to use the tear-off ones. I guess one of the sales reps for one of the companies which has drugs requiring med guies dropped them off... though maybe there is a place you could order them too...
 

Priapism321

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clachan3

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I usually have to dig them out from the confidential trash and put it with the Rx. We got an email from supervisor to make sure we give them out, it's the law I believe...
 
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pharmagirl

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I usually have to dig them out from the confidential trash and put it wit the Rx. We got an email from supervisor to make sure we give them out, it's the law I believe...
Yep, from what I've read you have to give them out with all new fills and every refill thereafter.

Does your system print them automatically when they are required? I found out that ours does, I just have to figure out how to make it do it.
 

DHG

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What's really interesting about it is that even though its "law" to give them with certain drugs, even the FDA doesn't tell you which ones are actually required. Oh, they have a list online, but it's not complete (says so in the small print).

Theoretical question: How can we be held legally responsible for making sure every drug on their list gets a sheet when they don't even provide a comprehensive, up to date list of all the drugs that are supposed to have a sheet?

Craziness, I say.
 

pharmagirl

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What's really interesting about it is that even though its "law" to give them with certain drugs, even the FDA doesn't tell you which ones are actually required. Oh, they have a list online, but it's not complete (says so in the small print).
I agree completely! The supposed "list" is definitely not very concrete.
 
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