FDA-MedWatch-and-Patient-Safety---Transcript

drugs, devices, biologics, and other productsthat we're going to talk about today.But we're also -- it's not only FDA as a regulatory agency, but the slides -- I'mnot sure I have this sl

UNITED STATES OF AMERICAFOOD & DRUG ADMINISTRATION

+ + + + +OFFICE OF THE COMMISSIONER

+ + + + +MedWatch AND PATIENT SAFETY

WEBINAR+ + + + +

WEDNESDAY,DECEMBER 16, 2009+ + + + +

1:30 p.m

MS FURIA: Today's speaker is Dr.Norman Marks Dr Marks has been a medicaldirector of the FDA's MedWatch, SafetyInformation and Adverse Event ReportingProgram since April of 2000

Prior to that time, he was a medicalofficer in the Division of Reproductive andUrological Drug Products in the Center forDrug Evaluation and Research

Dr Marks practiced urologicalsurgery in the Midwest in both privatepractice and HMO settings from 1977 to 1998

He served as a medical officer forthe United States Public Health Service withthe Indian Health Service in western SouthDakota, and learned to appreciate and lovepublic health medicine during a medicalschool externship in rural eastern Nicaragua

So please welcome Dr Marks

DR MARKS: Thank you, Andrea Andwelcome to everyone I'm glad you're allhere I'm looking forward to thispresentation.

I told Andrea that I did this for apatient rep group with Joanne Miner two yearsago when we were more primitive in ourtechnology and we just had I think, at best,

we had paper handouts that we sent around

So hopefully this technology will actuallyhelp the conversation

But let me get started So I'm onthis first slide So I'm controlling theslides, right, Andrea? You want me to dothis, right? Clicking forward and

MS FURIA: Yes You control

DR MARKS: And I guess, I assumemost everyone can hear me If not, andthere's something on my end I can do, thensomeone should speak up and let me know

So the title of this talk, it saysFDA MedWatch and Patient Safety I'm going

to describe the entire MedWatch programbeyond what perhaps was in the blurb youmight've gotten.

We'll talk more about MedWatch thanjust half of it One of the two goals ofMedWatch has to do with reporting into us.I'm going to talk about that half ofMedWatch, and then the, getting the safetyinformation back out to you and yourproviders So those are the two halves ofMedWatch

And as the title suggests, MedWatchhas to do with, and FDA does also to a bigextent, with patient safety, andspecifically, we'll say human medicalproducts safety That's what we're going to

be talking about

So here's a bit of context for thesenext couple of slides that we should thinkabout This slide actually but thinkabout this

My sense when I joined FDA in 1998

was there in fact wasn't a national focus onpatient safety And to my mind, and some ofyou may be aware, that in 1999, for example,two things happened.

The Institute of Medicine published

a big long report from the experts around thecountry, doctors, pharmacists, nurses,patients, patient groups got together andthey published a report called the first

of three, that one is called To Err is Human

And they started raising theawareness of the public, which includes nowCongress and individual patients and patientgroups, academics, journalists

Happily, to my mind, patient safety

is on the minds of the public and it's alsosupported programmatically So that's a goodthing

And of course, the FDA is in themidst of all of that, as you all well know,because of our regulatory requirements tooversee the human medical products, the

drugs, devices, biologics, and other productsthat we're going to talk about today.

But we're also it's not only FDA

as a regulatory agency, but the slides I'mnot sure I have this slide in but in talksI've been giving recently, happily, I've beenciting a New England Journal article thatcame out this year on June 11, when our newcommissioner, Dr Margaret Hamburg, whoyou're well aware of, joined, and I thinkwalked into her office the first day of hernew job and she and her deputy, Dr.Sharfstein, published this article in NewEngland Journal, which was titled The FDA as

a Public Health Agency

And that meets my needs as a docworking here at FDA because I think we're apublic health agency

Beyond regulating a drug, orregulating a device, our goal, as a publichealth agency, is to provide good information

to the public

So the next slide, as I move forward

to that, the first bullet suggests somethingthat I believe after my years of practice,patient safety is important But what therest of the bullet says is it's really hard

to keep current, and there's more and moresophisticated devices

So while safety's important, yourdoc, your pharmacist, your nurse, hardworkingand busy, possibly has trouble, or needs somehelp, let's say, from us at the FDA inkeeping current

And since, as this bullet says,we're the first, often, to know when there'sreally something critical and new to be knownabout a medication that you're taking or yourchild is taking There's a new drug-druginteraction that wasn't known for the firstfew years this drug was on the market Now,

we know it at FDA

We want to know it as soon aspossible But we want to get it out to you

and your doctor so you can act on it, as itsays at the point of care.

MedWatch is partly about this issue

in the third bullet We need the help ofyour providers and you, as patients, and yourfamily members to report and let us know once

a product is on the market

And we want to know these types ofthings that are in this last, fourth bullet

We want to know, of course, what are calledadverse events, I think you know that term,side effects, serious side effects We want

to know about things that aren't sideeffects, but a product quality problem

These are all in the subsequentslide I'll go through these quickly

We want to know about things thatare unrelated to the first two bullets Wewant to know if there's a use error for adrug or a device that we can attenuate atFDA We want to know about therapeuticfailures We'll talk about all those types

of things.

Slide number 4 talks about what FDA,how we monitor human medical products Thefirst big bullet is something I suspect thisgroup knows already, but I'm going to mention

it anyway

The public generally doesn'tunderstand that FDA doesn't do these studiesbefore a drug, let's say, or a device comes

on the market, but we rely on rigorously donestudies by the manufacturer, who then submitthe data, and we, scientifically using bestscience, review the sponsor or themanufacturer or the company's data

So there are limits on howrigorously, you know, a product is studiedbefore it comes on the market, which makesthe second bullet more important I'll readit

It says: careful review of theseadverse experiences or side effects orunexpected harms once the drug or the device

or the biologic is on the market is reallycritical.

And that's what MedWatch is allabout I'm going to skip this slide except

to comment that it reinforces what I justsaid

There are limitations on what thebest science FDA does, and I'll mentiondrugs, but it represents all the products weregulate There are limits on what we canknow about the safety of a drug, in spite ofour very smart medical officers andtoxicologists who review these productsbefore they come on the market

So what are the limitations? This

is a slide I show to PharmD students whenthey come by here at FDA for their monthlyrotation

And I always tell them, well, this

is the one they can, on their paper document,they can put a little star next to it andremember this slide

The point of it, without going intodetail, is that when, for example, a drug isstudied before it's on the market, it's donescientifically The drug is tested eitheragainst another product or against what'scalled a placebo.

But as the first three bullets say,

we don't ask the manufacturers, or themanufacturers don't test it against largenumbers of patients It's a smaller number

of patients

And the patients enrolled in thesetrials are often excluded if they havecomplicated medical conditions or concurrentmedicines that would complicate the studythat's intended to prove that the drug works

It's hard to enroll, as a lot of youknow, young pediatric patients or elderly,and yet those are often the ones who areusing these chronic medications

And finally, these studies can only

go on so long, often it's, let's say, months

rather than years And yet the drugs thatwe're approving are used for chronic diseaseslike diabetes or high blood pressure, whenthe real patients taking the product will infact take them for a lifetime perhaps, andthe side effects may show up only later.

So we know that our very well doneFDA review process will require that wereally get a handle on a product once it's onthe market And that's where you as apatient or where your doctor comes in

So let's talk about this whole one of the two MedWatch goals, which is tofacilitate and promote what's called avoluntary reporting of the adverse events,and other types of reports mentioned in anearlier slide

Sorry about the way this projects.The graphic, for some reason, cuts off part

of this

But let's talk about what to report

on, when to report, how to report, and why

the report makes a difference.

By the way, Andrea, do we have thatvideo or not at some point?

MS FURIA: No, it didn't look likethey were able to figure that out

DR MARKS: Yes, okay Okay.That's fine So now I'm on slide 8, and this

is really what to report

On this list is everything those

of you scanning it would say, yes, these areall human medical products MedWatch doesn'treceive reports on animal health products,vet med products, although FDA regulates.And the MedWatch reports aren't, in fact, forthe food products that FDA regulates

So this MedWatch program that I'mdescribing work and isn't for reporting someproblem with alfalfa sprouts or chili beans

or tomatoes, but human healthcare products

So what are those products? They'reany drug, whether it's prescription or overthe counter, any medical device And those

devices can be anything from a cardiac stent

to an IV pump that's at your bedside, or ahip implant, or also big radiological deviceslike CAT Scans, PET scans

Those are all and lab tests, bythe way, also are regulated by FDA to makesure they're reliable

Biologics, except vaccines, are notreported through MedWatch, but FDA regulatesvaccines

And then there's this funny andcosmetics Some of those cosmetics, ofcourse, can cause side effects and we want toknow that at FDA

And then this term, which isn'tmeaningful, special nutritional products is aterm from our food safety center But itmeans things like dietary supplements,instant formulas, and medical foods

All of these types of things arethings that we want to come in as MedWatchreports

Specifically, what reports do wewant? We don't want necessarily routinereports I don't want to overstate what I

am about to say, but to the extent that adrug is well known to cause a rash, which isbothersome but not serious, and it's wellknown to the patients taking the medicine, tothe doctors prescribing it, or thepharmacists dispensing it, we don'tnecessarily need one more report on atroublesome but not serious rash

But what we want are, as the bulletsays, serious adverse events But serious is

a regulatory term that I'm not it may be

on a subsequent slide that themanufacturers have to follow

But in speaking to you folks, I'dsay for you or your doctor, your pharmacist

or nurse, if a product causes a harm and it'sjust clinically serious and worrisome, we'drather know it at FDA than not know it

So serious is a regulatory

definition, but in the more common sense,it's anything important.

We also want, as I said, the otherthree categories We want to knowparticularly about product quality problems,like suspected counterfeit drugs, an unstableliquid product you get some insulin in avial and it has some precipitate in it

Or we want to know from yourpharmacist or from you if the way the drug islabeled and packaged is so confusing thatthere are errors of interpretation, sincehere at FDA we regulate the labeling or thepackaging

We want to know about defectivecomponents of devices

The third bullet says we want toknow about use errors, which have to do withname confusion, two drugs that sound the sameand they look the same in writing andtherefore, they're just, the wrong medicine

is dispensed

You know, Zyban and Zyvox, forexample The pharmacist may catch it butreport, or it may not be caught and thepatient may go home and the spouse says, wait

a minute, that doesn't look like your pill,you go back to the pharmacist And, oh,yes, they meant to dispense Zyvox and theydispensed Zyban

Those are important, and FDA has theability to control the naming of products

And finally therapeutic failures.With more generics, there's some controversy,

at least among the public, about whethergenerics, or one generic versus anothergeneric, works the same, whether there areside effects, or effectiveness FDA is muchinterested at least in hearing aboutsuspicions like that

Slide 10, I'm going to skip thisbecause this is the regulatory definition ofseriousness, certainly fatal or lifethreatening

But again, we want reports from you

as patients, patient groups, from yourdoctors, nurses, and pharmacists, if you justrecognize that it's clinically important,whatever the regulatory definition is

So here we are on I don't knowwhat slide we're on, maybe it's 11 now Butthis is how to report

So some of you may, as patient reps,have been on the FDA's website And theforms to report online are on the MedWatchwebsite itself, which is I won't say it'sburied within that big FDA website, but itisn't as readily apparent as perhaps even I'dwant it Whoever's listening can hear me saythat I'd like the access off the homepage

to be even more obvious

But if you do go back tonight to theFDA's homepage, you'll see a sidebar on theright It does say reporting a problem, andthere's a link that will take you to theMedWatch homepage and then to the reporting

So I might just let you all knowthat a lot of folks use the internet forreporting, compared to the early 90s, ofcourse, when MedWatch was rolled out in `93

It used to be a paper process wherepeople got a paper form, filled it out with apen or pencil, folded it in thirds, andmailed it in Or later on, they startedfaxing things in

Well, you can still mail or fax, asthe slide says, or you can call that 800number, and you will either get a form mailed

to you, or there's some chance you can reportover the phone

But in fact, two-thirds of thereports we get directly to MedWatch on thesedrugs, devices, biologics, come in online

They either fill in the form you'reseeing on the screen on the lower right,which is a PDF view of the one-page form, oryou can click through the multiple pages of

what's called the HTML version.

Now, just as an aside, it's not onhere, but the number of reports the FDA getsfrom healthcare professionals or patients arehuge numbers

Just for, giving you an example,just for drugs and what are calledtherapeutic biologics, last year, FDA gotreports it started with a reporter,patient, doctor, nurse, pharmacist, eitherwent directly to FDA, to MedWatch that'scalled a direct report or it happened to

go through the drug company, let's say, andthen to FDA We call that an indirectreport Either way, they all come to FDA

Last year, there were over probably270,000 drug adverse events reports that came

in indirectly They still come from you andyour doctor, but they go to the manufacturerand FDA gets them Those were the onescalled serious required regulatory

There are another 40,000 or so

reports that come directly to FDA through ourvoluntary MedWatch program And as I said,two-thirds of those are online.

So that's how to report

The form itself here's a screenshot on slide 12 of the paper form has alot of boxes in it But don't be intimidatedbecause, as it says here, we only really needfour things to make it a report

We want there to be an identifiablepatient, although we don't want your socialsecurity number In fact, we want, if yourdoctor sends in this report, to use some sort

of a coded identification So we don't want

to know your name, we just want to know thatyou exist

We do want as much detail on theproduct as possible That's what the seconditem says We want especially some detail ornarrative about what you experienced, justusing a patient report can be rigorousscientific data including lab work, but it

can also be a useful narrative description ofwhat happened when.

And finally we do need we cannotaccept anonymous and don't report So wewant a reporter

So that's the elements of a report,four items Every report can make adifference

So if you actually wanted toremember anything from this talk I'm giving,this actually might be the image you want toremember because I, with my work here thelast eight to ten years with MedWatch,believe this is so

Just picture this slide There'sthe FDA sitting there in the mid-Atlantic inMaryland And there are four, five reportscoming in, all at I'm making up thisstory, but it happens many times year in andyear out

A product, let's say a drug, a newdrug on the market for a couple of, six

months, is having side effects that we didn'tknow about.

Well, out there in the state ofWashington an oncologist actually observes

it He picks up the phone, calls in and weget a report from him

Meanwhile, the next day, there's anurse taking care of a patient in Sacramento,California She sees that same side effect.She doesn't know anything about what's going

on in Washington or Texas or Florida, but shethinks to send in a report

And I don't have a patient on thisslide A patient from Houston, Texas, maynotice a side effect, mention it to thedoctor, let's say, but knows to report toFDA

My point is that within a week or

so, it's not unlikely we could get fivereports all telling us the same thing, andyet these five people don't know each otherand never would get to So where do they

come together?

In the Center, let's say, for Drugs.And the post-marketing safety surveillanceteam is really very good and captures thisreport

And this then, as the slide says,can become a signal as it leads to a labelingchange or some safety action

Again, this is just a transitionslide, so let me talk about these threebullets in the coming slides, what happenswhen you report these three different types

of problems

If you do report a serious sideeffect, it immediately goes into a database,

in fact, one that we're in the next year or

so going to improve, I'm told, to make itmuch more powerful to use, and in fact, makethe data more available, transparent to thepublic So that's a good thing

Here's the neat thing, the secondbullet The database is monitored day in and