Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
(00:03):
Welcome to the First Fill.
My name is Katie Meyerand I serve as the Senior Director of Content
Creation here at APhAand I am very excited to be your host.
I'm here live in Nashville, Tennessee,with my esteemed
colleague, mentor and friend,Remington Award winner Dr.
Dan Hussar.
If you've completed APhA’s Pharmacy today, CPE on
new drugs over the past15 to 20 years, you're familiar with Dr.
(00:26):
Hussars updateand I'm delighted to have him as a guest today.
If you haven't caught episode one this month,be sure to check that out
as we discuss two new recent drug approvalsthat pharmacies should be on the lookout for.
Today, Dr.
Hussar will provide us with informationabout his approach to evaluating new drug
approvals and provide pharmacistswith recommendations
(00:47):
for staying up to date on the latestand greatest in pharmacy amidst a busy life.
So welcome, Dr. Hussar.
Thank you, Katie.
To start, could you introduce yourselfand provide listeners with a bit of background
information about how,when and why new drugs became your area of focus?
Well,
Katie, I wishI could say that I came up with the initial idea,
(01:09):
but one of my mentors, Linwood Tice,who was the dean of the Philadelphia
College of Pharmacy, past president of APhA,
hired me to the facultyof the Philadelphia College of Pharmacy,
and he was the editorof the American Journal of Pharmacy,
(01:30):
which was a pretty low circulation journal
that the College of PhiladelphiaCollege of Pharmacy published.
And for a number of years
prior to my coming to pharmacy school,
he had written an annual article on new drugs.
Now, this is ancient history,
(01:52):
and this was before the time that pharmacists
were educated in to assume responsibility
for patient’s drug therapy.
So we were not, and he was not at that point
an advocate for pharmacists
communicating with patients about the drugs.
(02:15):
He wanted to keep pharmacists informed of what
the newest drugs in our area were.
Now, when he became very busy
during that period of time,
he was dean and also president of APhA.
He didn't have enough time to do thatand he asked me
(02:37):
if I would want to succeed himin developing those and your articles.
And I know that all of this says is how old I am.
But my first article on new drugswas the new drugs of 1968
and 69 and two years,
because I had the catch up on a yearthat he didn't have time to do it.
(03:00):
But I just found
it was a learning experience for me.
And at that time, part of our presentation
was the chemical structurethat was a big part of a pharmacist education.
Then,
but I enjoyed doing that.
At that time there weren't as many new drugsin the market each year as there are now. And
(03:26):
as we did as pharmacist,
had not only the opportunities,
we requirements to participatein continuing education programs.
And this became a topicthat I was asked to speak on.
And at that time, pharmaceutical companiesweren't really sponsoring
(03:49):
educational programs sort of come full cycle
and it has become an opportunity for menot only to write about the articles,
but then speak about them and that has provided
a wonderful professional opportunityfrom which I have learned so much.
(04:10):
Absolutely.
Thank you so much for that.
I honestly didn't know that story.
And we've known each other for a very long time,so that's great.
And so with that next, let's talk a little bit
about your approach to evaluating a new drugthat comes out to the market.
So can you tell listenersjust about your general approach,
some of the characteristics that you considerwhen you're looking at a new drugs potential?
(04:34):
When I
learn a new drug has been approved,
I will
first of all
get the product labeling the packageinsert and learn
as much as I can about that,whether they're typically for new drugs.
There is very little,if any, in the way of published literature.
(04:56):
Even on the research studies,some of them are proprietary
and some of them just are too recentto get into the publication cycle.
But as I look at the new drug information,
initially it was essentially reporting
on the different components
(05:20):
of the clinical studies, the uses.
But as I progressed year to year, the questions
I would get the most often about new drugs is
how does the new drug compare with older drugs,with which I'm already familiar?
Does it have advantages?
(05:41):
Does it have disadvantages?
So I think it was in 2002.
I developed nothing magical about it,
but the numerical rating system.
And as I would look at the informationon the new drug and my it
my approach is to try to make it
(06:04):
try to provide the informationthat is most practical
for our pharmacists, physicians, patients
to utilize and to understand and utilize.
So that was a focus.
I won't go into great detailon the research studies.
If the FDA approved it.
(06:24):
Somebody has pretty thoroughlyanalyzed the studies and information.
So what I would do
in response, I developed this rating system
on a scale of 1 to 5with five being the highest rating.
And I would not be very generousin giving a rating of five.
(06:47):
Typically, it would be for a new drug
for which there was no preferred condition,for which there was no previous treatment.
And that might be a rare drugthat most pharmacists
are not going to see or get a prescription foror even get a question about it.
And what I would dowhen I had the information about the new drug,
(07:12):
I would identify where possible.
And usually it is what agents
previously have been used for this treatment.
And I looked for the background informationon those agents
and identifythe one to which the new drug was most
comparable.
(07:32):
And then I would develop what I identify
as advantages of the new drug
as well as the disadvantages.
And then I pulled those together and provide
my reading for the new drug.
And that's been a source of enjoyment
(07:54):
too, because as is true for almost every area,
drug therapy, there can be differences of opinion,
and depending on where an individual is working,
the prescribers and their area.
So we can have a little funwith that in the presentation
and asking the audiencehow they would rate a new drug and typically were
(08:19):
we're right on targetperhaps from the bias of my comments, but
otherwise.
So I try to focus on the most practical thing for,
I mean, at an APhA meeting,
the activities of a group that would be attending
(08:39):
my session would be wide spread.
I mean, community hospital, long term
care, stockbrokers, lawyers.
It's so anyway, we
I then determine a rating from 1 to 5.
(09:00):
Now fortunately there aren't many onewhich is basically
no advantage
and after all,
if a company is going to invest that much moneyand doing research on a new drug, you got to hope
that there is something that sets them apartfrom the previous one and that.
(09:21):
So I've added that to my presentations.
Typically my presentations, because they're moreinteractive than a journal article would be.
And I think as a value to the audience,
and I've had individuals say that on evaluations
(09:42):
that they appreciate that because it gets them
thinking, you know, in my experience, you know,how do I view that drug?
Is it the same way?
Yeah, Yeah. No, I love that perspective.
It definitely gives you perspectivein terms of how effective or how often
you're going to be seeing the drug really comparedto the other agents that are out there for sure.
(10:03):
So that's awesome.
All right.
So let's shiftgears over to the patient a little bit.
Right. So
what are someof the factors that pharmacists should consider
when they're determiningwhat that most appropriate information is to relay
to the patient that comes to their counterinquiring about a new drug?
Well, that's it'sa very important question, Katie, because
(10:28):
with the package information, leaflets
that are now provided to patients, I mean,
first of all, many patients
don't have good reading ability
and a one page, two page of patient instructions.
This is what they need to know.
A lot of people aren'tgoing to persevere through that.
(10:50):
So, I mean, in terms of a pharmacistworking in a pharmacy
and having pertinent informationprovided on a computer, I mean, we've we
both of heard are aware of the the fatigue alert,
the alert fatigue where so much comes up.
You've got to make a judgment in terms of
(11:13):
what is most important for a patient to know.
So the approach I would take their
first of all aspects of administeringthe drug, let's say
a capsule or a tablet,the most convenient oral dosage form,
if there were any
recommendation with regard to administration,
(11:34):
with respect to meals or apart from mealsand some of the drugs
I'll be discussing at the session tomorrow,have that
consideration to that is very important.
Does the patient understand
what the benefits of the medication are?
And it's important that
(11:58):
the pharmacist
have the awareness of drug interactions.
And sometimes we think of drug interactionsas involving
prescription medicationswith other prescription medications as well.
The OTC drugs, dietary supplements, St John's Wart
can interact with so many things.
(12:19):
So just a complete
awareness on the pharmacist part
of what other products the patient is using.
And then what I do is emphasize
the most common adverse events
and then lightly or quickly
(12:42):
identify some serious
not that I mean,usually the serious reactions are so rare
that most pharmacists in their lifetime experience
are not going to observeor have patients who experience those.
But for example, penicillin and the importance
(13:02):
of ruling out any history of penicillin allergyand the fact that the penicillins are related
to the cephalosporins and then a new carbapenemI'm going to be speaking about tomorrow.
So this isn't an allergy to one. It's going to
transfer
to the other medicationswith similar structures and properties.
(13:22):
You know, all of that makes perfect sense
and really focusing on the most important thingthat they can take away.
And there's big things to be on the lookout for.
So do not scare them too.
You don't on to scare them away because thenthey won't take the medication in the first place.
Right. Right.
So I think emphasizing the intended benefitfor which it is used.
(13:43):
But even the more common side effectsmay not affect more than 10% of.
So the typical patient that comesin, they're not going to experience it.
Okay. Yeah.
Awesome.
Well, last but not least, I remember vividly,honestly, as a pharmacy student
sitting in your office wondering how in the heckyou stay up to date with everything.
And I asked you that question.
(14:04):
I don't know if you remember that,but I still remember it.
And I still use some of those strategiesthat you told me
to say used to stay up to date, to stay up to datetoday.
So was just hoping you can tell our listenersa little bit about some strategies and resources
or recommendations to help them stay up to datewith all that's going on in pharmacy.
Well,
(14:25):
I who
admittedly when I was a full time faculty memberthat had a professional focus
on this area, as I still do, and retirement
have more time than a busy practicing pharmacist
to look at the properties of the drug
(14:47):
to stay as up to date as possible.
The last thing I want to see happenis to be at a presentation where
I'm speaking on new drugs and have a pharmacistcome up to me after the meeting and say,
Oh, what do you think about this drugthat was just approved two days ago?
And no, I want to know aboutI should know about that drug that was approved
(15:09):
two days agoor even yesterday or even this morning.
So keeping up,
I follow very closely the FDA
approval and you can actually
get on an FDA distribution
e-mail, email, distribution
(15:30):
site that will communicate informationabout new drugs.
If the new drug is of particular importance
that the FDA will typically developa press release.
Now, on the FDA website,
there is a record
that that a new drug approval.
(15:52):
Now one of them is
approvals of all types, not only new drugs,
but a new indication, a manufacturing change.
I mean, that could be mindboggling and trying to sort through all that.
But there is another option to go to the original
(16:13):
new drug application or biological license
application to access that information,which is much shorter.
So I will check that frequently
and I would, and then there are several journals
that sometimes have public versions of drugsthat are not yet approved.
(16:33):
I mean, New England Journal of Medicine
being one example of that.
So I will follow that information.
I remember the days when I would use to call
or write the manufacturer ofI have a copy of the print
package insert sent to me.
(16:56):
Well, now
I can quickly access the package, insert
almost a minute after it appears as an approval.
And typically it's the brand name of the drug.com
and I can almost immediatelyaccess the patient, insert
the package insert for that drug.
(17:18):
So that's part of the approach that I use.
I also
oftentimesthe company will provide a press release.
I mean, actually they'll issue press releasesfor every new drug that they get approved.
But and the FDA for selected new drugs,the company
(17:39):
press release, I mean, as you would expect,I mean, it has to be balanced.
It has to include the risk, but it also provides
some background information about the medication,
the history of its development,also about the condition.
And I'll be the first to say thatsometimes the first time I ever heard
(18:02):
about the condition being treatedis when the first drug of the treated.
So it's a learning process too.
So it's it's a combination of factors.
And I typically try to
access at least
(18:22):
one current light publication.
Wall Street Journal, for example,
will be right on top of important approvalsand don't put their reporting
and editorial background.
They've searched out the information.
Also from a different perspective,the news perspective rather than the news
(18:44):
professional perspective, I would add.
Yeah, no, that that's great.
A lot of great tips there.
I remember from sitting in your office,the FDA is a resource
that I feel like you might have hadand there's other ones that is
in fact what anyone thinks,and I'm dating myself as well.
So thanks so much for sharing with listenerstoday.
(19:05):
It was definitely a great conversationand I appreciate it very much.
All right.
So I'm going to take a moment to just summarizemajor takeaways from our time here today.
First, when considering new drugapprovals, it's often quite beneficial
to compare the new drug to other medicationsthat are currently on the market
(19:26):
to determine advantages, disadvantages,and that can really help
formulate a mindset aroundwhat to communicate with patients as well.
So focusing in on those application based
things such as the patient,take the medication with food,
how often should they be taking it,
and then maybe the top side
(19:53):
effects and then
last but not least,
you can certainly subscribe to FDA
for any new drug approvals and then follow
even maybe a non-medical journal like Wall Street
Journal to get some information there as well.
So with that,
(20:15):
that's all the time we have here for today.
Like I said, if you haven't listened to partone of this most personal podcast yet,
it was releasedjust last week and that episode we discussed
two new recent drug approvalswith four pharmacists to be on the lookout for.
If you enjoyed this month's update on new drugs,be sure to check out our March pharmacy today
(20:36):
CE in the learning Library for a deeper
dive into additional agentsthat have come to market recently.
And then last but not least,don't forget to visit the Learning Library
to earn your CE for free for this month podcastat learn.pharmacist.com.
Take care and thanks so much for listening.