P R O C E E D I N G S (8 :00 a.m.)
DR. WOOD: Welcome to this meeting on regulatory reform. For those of you in the public audience, today when we have a public comment, let me encourage you to start thinking about things now. This committee has been most concerned about finding solutions to problems that are indeed regulatory. Our charge does not include finding solutions to monetary problems. That is especially finding either new payment sources or creating new payment sources or anything related to dollars.
We also have a large number of people who have requested time to speak. In fact, because of the number of people who want to speak, we'll try to make some additional time; but we will ask each of you to keep your comments to four minutes. And I will have to be a bit more forceful about a four-minute time limit than I would like to be. But in order to make sure that everybody has a chance to make a comment, then I hope that we will all be respectful of each other's time, so all of us will have a chance to make those comments.
Today we will begin with a panel discussion of adverse event reporting. As has been the case in all of the things that we have done, we have tried to understand the statutory basis of what it is that the series of regulations are aimed at achieving. And it has always been our privilege to have experts from different parts of HHS with us to give us a background on what statutory requirements happen to be and how they are approaching their work.
We're also quite fortunate to have with us people from the field who can give us an idea of how things are actually working in the field. And we use those comments to help us in terms of formulating recommendations. Now, we have some subcommittees who have been working at several of these things, and some of them have some draft recommendations. But for those members of the panel who are here, let me tell you that those are draft; and we will be very anxious to hear your specific insights and recommendations so we can revise those before we go forward.
To begin the discussion today, I'm particularly pleased to welcome Dr.Steve Galson, who is the Deputy Director of the Center for Drug Evaluation and Research at the Food and Drug Administration. He will lead with a discussion of adverse event reporting of pharmaceuticals. And then I'll introduce the other panel members later. So Dr. Galson.
DR. GALSON: Okay. Thanks very much. I'm really happy to be here today. You received a hand-out on this subject in your briefing book, and I'm not going to go along with the hand-outs. I use some of those slides, but there are a number of new ones, so don't bother following along with it. Just watch up on the screen, and you'll be able to see what I'm doing.
This is a very complex area, adverse medical reporting. And I'm going to give you sort of a tour of it focusing on some specific issues. I'm going to go fairly quickly. If you could save up your questions for the end, I'll try to leave some time at the end of my remarks so you can ask me some specific questions.
First again I could spend fifteen minutes on this slide, but I won't. Just to let you understand the sources of risk from drug products and how they move into the adverse events that are what we are talking about today, the reports of those adverse events. We can get adverse events from known side effects of drugs, whether they're avoidable or unavoidable.
Another source of adverse events is errors. For example, if a pharmacist gives us the wrong drug. The patient thinks it's something, but it's something else. There are also product quality defects in manufacturing that can contribute to adverse events. And it's always important when talking about drug risks to realize that there are uncertainties when you take prescription drugs that we don't know about when the drug is approved. And those are in the right corner: Unexpected side effects, unstudied uses. They're groups in whom the drugs aren't studied before they're approved, and so we'll always get reports from there. Again just to give you the broad overview here.
I'm going to focus on talking about FDA's adverse event reporting system, which is called AERS. There is something missing here. Okay. I missed that slide. This is just an overview of what I'm going to talk about. The first is what happens after FDA approves a drug for marketing. How do we actually get this data? What do we do with it? How do we get the data and in what different kinds of ways does it come to us, and what do we do when we get it to figure out whether there is a problem?
I'm going to touch on the adverse event system for devices, and we can take some questions about it if you have more detailed issues. We're going to talk about some of the research that we do on adverse event reports, our relationship with an academic group called CERTs. And I'll explain what that is later. We'll touch on some new initiatives that are taking place having to do with adverse event reports and then touch a little bit on the recommendations that you received from your subgroup. So I'm going to try to do all this in 35 minutes or 30 minutes.
Okay. First of all, the system that we have at FDA is a passive reporting system. Passive is a term of art. What that basically means is the reports come to us not because we require them to come from all the sources, but it's when people decide to send in the reports. So there is nothing forcing a practitioner to report an adverse event report. That's the most important thing. There is nothing forcing a practitioner to fill out a report and send it to the FDA.
There is a requirement that companies, drug companies, that receive adverse event reports report them to the agency; but again practitioners don't have to report them. We get 90 percent of our reports from health care providers; M.D.'s, RN's, pharmacists, etcetera.
We try to focus on serious known or serious unknown. And what I mean by known and unknown is that when we approve a drug, in the labeling for the drug, as you all know, are listed the known side effects. Those are the known ones. There are also surprises. Those would be the unknown ones. And medication errors. MedWatch was the other tier of our system, is the system that allows people to directly report to us problems, not going through drug companies. We get just 10 percent of our reports through that system.
There are different kinds of reports, and again I'm not going to go into this in a lot of detail. Drug companies are required to give us what are called 15-day reports. That just means they report to us within 15 days. If the events are serious and unexpected, and that's the definition of a serious and unexpected report under our statute, and I won't go into that later. I mean I won't go into it in more detail.
They are also required to give us periodic reports, which are every few months. They have to send us a summary report of all the reports that they have received over that time period. And then, as I mentioned, we get direct reports through the MedWatch system from individual consumers and other sources.
What's happened over time to these reports? As you see, the last full year, we've got '01, almost three hundred thousand reports a year. That's a lot. And it's split up there, so you can see the different sources. Don't think when you first see this that this means drugs are more dangerous. There are a lot of reasons that this number has gone up that don't have to do with the possibility that drugs are more dangerous, including the fact there are more drugs out there and people are taking more drugs. So just from those two points alone, we would have and you would expect to see an increase.
Another thing that causes fluctuation and perhaps a secular trend like this is that people are becoming more and more aware of side effects of drugs; and, therefore, the reporting is generally going up. So there are a lot of reasons for this increase.
How do we use AERS, the adverse event reporting system? We use it to figure out if there is a problem with a drug that we didn't know about, and that's what safety signal detection means. We use it to look at specific cases, so specific problems with a type of drug or a class of drugs and figure out who is getting that kind of drug and which type of patient is running into trouble and suffering adverse events.
We use it to generate hypotheses for further study. If there is a signal that we see that we didn't expect, it could help us frame research for the future. It also tells us if there is a confusion about a name. As you know, there are lots of drug names that consultants are paid a lot of money by the drug companies to come up with new names, but sometimes the names are extremely similar to old names. We try to stop that before it happens, but sometimes we don't pick it up. And the AERS system lets us find out when the wrong drug is being prescribed. That's pretty obvious.
Briefly, what are some of the limitations of this system? The first is the active versus passive issue that I discussed at the very beginning. Practitioners are not required to tell us about these events. So there are some that are certainly going to fall through the cracks, resulting in a fairly large degree of underreporting, depending on the estimate. And this has been looked at by lots of different people, and there are some different numbers, but there is a general agreement that we only get reports of about 10 percent of all adverse drug events.
The secular trends, which I mentioned before, it's very, very difficult to separate when a drug first comes on the market whether an increase in reports is due to the fact that there is a problem with the drug or just because there is more publicity about it. And without getting all reports, it's going to always be difficult to look at that, which is linked to no direct denominator, which means we don't know for any one drug at any one moment because we don't have a national system that requires this data how many people are taking any one drug.
So when we have, for example, ten adverse events in one week that come in on a drug, we don't really know if that's a change from the week before because we don't know whether the use of the drug has increased by ten over that time. So that's a weakness. And then incomplete reporting, which I've already talked on.
Despite all these limitations, three hundred thousand reports a year is a lot, and it's the primary way that we find out when there are problems with drugs. And we get a lot of information about it, and we make important decisions about public health of the nation based on this data base. So I don't mean to just focus on the limitations.
And the reason is that what happens in the real world is very different from the clinical trials under which drugs are developed. There are different populations of people who take the drug. There are people who have diseases that may not have been anticipated in the trials, so that other diseases interact with the drugs in different ways.
We can definitely not predict if people are taking two drugs at the same time. It's extremely difficult. We do modeling and some testing of that, but we can't imagine all the different combinations of drug uses that take place.
Off-label use which basically means people taking drugs for uses that have not been approved by the FDA, which is, of course, not illegal. We don't regulate it. And, in fact, some extremely important clinical uses of drugs are off-label again; but we wouldn't understand necessarily before the drug is approved all the implications of those uses.
And then there are always rare events, as I mentioned. There are things that go on after drugs are approved that we don't anticipate. We can't be expected to anticipate, and it's very important that this system detect them.
The MedWatch system, which is the connection of this reporting system to the public, as opposed to the physicians, is just an abbreviation or a meaning for FDA safety information, adverse event reporting system. It includes health care practitioners, but I think the most important aspect of it is it's a window on the system for the public.
It covers prescription drugs, over-the-counter drugs, devices, biologics and all nutritionals. And it's a two-way system. It gets reports in to us, but it's also a way for us to communicate with the public about issues that come up with drugs so that they know about them as soon as possible.
When we have an alert or a recall or information that we know about errors or drug shortages or label changes, we have a MedWatch group of people that are connected to us by the Internet, by e-mail; and we can send messages out to tens of thousands of people, even in the hundreds of thousands of people because the messages are then transmitted by professional organizations or health care provider organizations. So it's a way for us to get information out quickly to many, many people. We have partnerships between MedWatch and major medical organizations, so that when we know about a problem with a drug, we send it to the organization. They automatically send it out to their members.
Through MedWatch we've got twenty-two thousand reports in 2001, so compare that to about three hundred thousand total. 35 come in direct, 35 percent directly through the Internet, 53 percent from pharmacists. And you can see the rest of the numbers there. We posted-- this is giving the information back to the public-- 65 alerts. We've got 180 professional organizations who are partnered with us. And on our direct list server, our e-mail list server, we've got twenty-three thousand individual health care providers, consumer and media subscribers.
I want to touch a little bit on how we do adverse event reporting for devices, and this is somewhat different. There is some overlaps. There is some specific differences, and I'm going to go through it quite quickly. There was a special law passed by Congress in 1990 that resulted in final regulations in 1996 on device reporting.
The death reports come directly to FDA. The deaths and serious injury reports go to the manufacturer. There is a requirement of reports coming in within ten working days, and there is a requirement for an annual report with the FDA. User facilities are key in the device reporting system; hospitals, ambulatory surgery centers, etcetera, as listed there, in a very different way from the drug reports.
The individual user facility becomes aware of a device problem from any source, and the regulation says that if they-- and this is the language actually in the regulation-- reasonably suggest a device may have caused or contributed to the death, they have to tell us about it.
MedSun is a medical product surveillance network, which is active with the device area, so current user facility reporting go into this system. There is also a considerable under- reporting with the device system; but one of the things that the MedSun system does extremely well, which again is focused on devices, is there are partnerships between this and a specific group of specific user facilities, much more direct interaction between the system and those facilities. So that in the group facilities that are part of the MedSun network, we have a much higher confidence level that the reports are all coming in. We're hoping that eventually there will be five hundred facilities in the MedSun network.
Currently there is seventy hospitals and ten nursing homes and all the death, serious injury and close-call reports go into that system through an Internet reporting. We use a contractor. There is a risk manager and biomedical engineer that have signed up at each site to give us high quality reports; and the contractors review those reports and the codes, do follow-up and make sure the reports get in to the agency.
We have some interesting feedback and incentives in terms of monthly newsletters. They hear about new products. They hear about recalls, so it's not just sending information to us. It's getting information back out to the user facilities, and we think this is one of the important ways that contribute to the success of the MedSun system.
I want to shift gears now and talk about the Centers for Education and Research on Theraputics or CERTs. This is a group of academic centers that partner with government agencies to do research and education on therapeutics. It was authorized by Congress in 1997 as part of the FDA Modernization Act. It's not sponsored or run by FDA. It's run by the Agency for Health Care. Research and Quality, as you all know, is another HHS agency. And it's mandated to work with us to conduct applied research on drugs and other products, regulate to focus on optimal use of those products.
The sites are around the country. Those are the current sites. What this group tries to do is to act as a national resource for people seeking to improve health through the best use of medical therapies. What they do is targeted research. It's not basic science research like NIH. It's targeted research on therapeutic areas in terms of looking at how these are used, how to prevent problems, comparing different types of therapeutics. And it's extremely important use-- extremely important information for people who make decisions about how to use scarce health care resources. And FDA would like to see this whole program increase.
We also have various other kinds of applied research at FDA. Some of it has come through cooperative agreements. Some of it is done internally by our own staff. When we identify a safety concern with a certain group of products or we want to know how effective our regulatory tools are in terms of limiting use of a drug or communicating a specific risk, we might do applied research. But again we have very, very limited resources focused on this.
The questions we're trying to answer with this applied research is is the knowledge that we already have about benefits, risks indications, monitoring, etcetera, reaching the physician? Are they understanding it? Are the pharmacists getting the information and acting on it? And in the end, is the patient getting the information? Are they able to make informed choices?
This is something that's grown over the last -- this area of applied research has grown over the last few years with the CERTs and FDA trying to apply more of its internal resources. But again the resources applied to this as compared to the health care budget of the nation compared to NIH basic research is timely; very, very timely.
I want to touch on some new initiatives in the agency that are contributing to changes in adverse event reporting systems. The first is the Best Pharmaceutical for Children's Act. I'm going to go into that in a little bit of detail because it touches on one of the initiatives that this group has received the recommendation on.
PDUFA, which is the Prescription Drug User Fee Act, which was just re-authorized by Congress, and I believe the President is going to sign that bill as part of the counter-terrorism, bioterrorism bill this week.
And then the Patient Safety Task Force, PSTF, which is an internal HHS group, which is also working on adverse event reporting. Again I know I'm going quickly, so jot down your questions. I'll try to give you more information during the question period.
In the Best Pharmaceutical for Children's Act, which President Bush signed at the beginning of this year, there are a lot of provisions having to do with safe use of pharmaceuticals in children; but there is a specific area that requires the agency for all drugs that are in Section 505, which is basically drugs -- it doesn't apply to devices and biologicals -- we're required to put a toll-free number, which is maintained by FDA, to receive sorts of adverse events and a statement that the number is to be used for reporting purposes only, not for medical advice.
We have a deadline of a year after enactment of the act, which is coming up in January. Very, very challenging requirement for us because the act tells us to at the same time reach the broadest consumer audience and minimize cost to pharmacies, which some people see as a conflicting requirement.
So we're considering a lot of options in how to comply with this act. We're considering requiring changes to physician labeling and the medication guides and requiring pharmacies to distribute a toll-free number. You really have to do that. The question is how to do it.
And some of the options that we're thinking about are including the toll-free number on a sticker that attaches to each drug vial and/or including the toll-free number on a separate piece of paper. As you all know, when you fill a prescription, you're supposed to be getting ancillary information. We can require the number to be put on that piece of paper. And when we do distribute medication guides, the medication guides will include the toll-free number as well.
The real challenges to the agency from this requirement is that with this toll-free number out there for everybody to see really in your face whenever you get a drug refilled or prescribed, we're going to get a huge increase in volume of calls. And there is a resource question there.
But there is also a question about the quality of the reports that we get. We really don't want to get a lot-- I shouldn't say we don't want to get. We're going to have difficulty knowing what to make of a large volume of poor quality reports from consumers that may cover a lot of issues that are not serious. For example, rashes. So we've got to work out how to get the real kernel of important public health data out of the increase in reports we're going to get.
We're going to meet the deadline and we're considering an interim rule, which the way an interim rule works is that it's effective upon publication of the rule, which is going to be in January. But it at the same time gives an opportunity for the public to comment on the rule. And we'll respond to comments and issue a final rule later on.
And very important to understand, because this will be imposing new requirements, is that it's going to include an implementation plan that allow manufacturers and pharmacies a phase-in period. So although the rule will be in effect in January, we will have a phase-in that will work it out.
Touching very quickly on the new user fee bill, there is some specific risk management proposals that are in there. And again I'm going to go through this quickly. What the new user fee bill does for the first time is it allows FDA to work with companies on post-approval issues and risk management issues. It allows us to use the user fees for the first time to continue work on a drug after it's approved. And I'm not going to go into the detail of this, but it basically lets us work both pre-approval on what we're going to do after approval and to monitor those actions after approval takes place.
For drugs that are approved after October of this year, we're going to be able to use those user fees to review implementation of risk management plans for three years on many products and review whether the drugs are actually being used according to their label, so this is going to enable us to do a lot more work. They give us the resources to be able to do a lot more work on whether drugs are being used the way that we think they're supposed to be used when we approve them. And it should help us in the long run to be able to develop risk management plans that are effective.
It also requires us to develop some guidances which are going to be extremely helpful for the industry on how we do risk assessment, what good risk management means and what good pharmacovigilance means. Pharmacovigilance is just another word for the epidemiologic assessment that we do with drugs after they're approved. So we're going to be developing over the next time period these guidances which should help the industry know where we're going on these issues.
The third of the new initiatives that I want to touch on quickly is this Patient Safety Task Force initiative. Again this is an internal task force. What we're working on across the HHS agencies are what's called a common data portal. And this is something that you're all going to be interested in because, as you know, for devices, for drugs, for all sorts of other reporting systems across Health and Human Services, there are very many different ways that department collects this information. There are a whole gamut of different forms, of different reporting mechanisms and requirements.
And what we've heard is that these are very confusing. So what the agencies are doing is working with all of the agencies that require this information to come up with, to look at whether we can have a common, what we call a common data forum. That might be Internet based. It might be one master form instead of a whole slew of forms. And this information would then go to the different reporting agencies; but instead of requiring all these different ways, forms of filling it out, it would be one common way.
We think this would simplify things for the user community. It's in the very, very early phases. But I want you to be aware that this is something that the agencies on their own are working on, and we're very excited about it.
I want to touch very quickly on some of the proposals that you've received from your coordination subcommittee. I've gotten one on patient empowerment, on a data base. Food/food, food/drug, drug/drug interaction. Data base where consumers could go to an Internet site or some other source, put in the drugs they're taking and get information. We think this is just great. Anything that empowers patients to get more information to make decisions about their health care directly, we're all for. We think it's very important.
You also received a recommendation on use of the toll-free number, which tracks very nicely what we have to do under the Best Pharmaceutical for Children Act.
You received a recommendation on use of an information technology system to improve adverse event reporting. That's a very general sort of recommendation, but we agree very strongly that in the future over the next few decades information technology is really going to be the key to improving the quality and the quantity and the usefulness of these reports. It's very difficult to know where to go right now. It's a piece. We have to go step by step in improving the information technology, but there is no question this is the wave of the future.
You also received a recommendation having to do with the CERTs, the academic partnership's role in recollection of data. One thing to keep in mind with that recommendation is that there is a risk to having the organization that collects the data be separate from the Food and Drug Administration that has to make the decisions about regulation of products.
We already have a lot of challenges in the agency in communication between the people who collect and maintain the adverse event reporting system and the people who make the regulatory decisions. Separating that data into a different agency could possibly create a lot of additional challenges.
I've got my closing slides here, and I want to just leave you with a couple thoughts. The first is what the FDA believes are the fundamental concepts in prevention of drug adverse events. This is something I know is the root of your interest in adverse event reporting. How do we prevent these events from taking place in the first place?
And the fundamental concept here is that education and communication are key. People can't avoid taking drugs incorrectly or combining them with other drugs if they're not aware that it's a problem in the first place. And this has to do with practitioners across the board; facilities, patients, physicians.
An effective approach to prevention has to have a systems approach. It can't just look at physicians, just look at drug companies or users. It has got to look at the whole system. And an approach that doesn't realize that the health care is delivered in a systems approach and there are a lot of different people making decisions again won't be effective.
We think that risk management tools have to be standardized so that people don't have to look up in a book for every special drug what the specific requirements are. We have to think of some way of making the tools that we're using to manage these risks simple and understandable.
And then the fourth concept that's extremely important to get back feedback on is how effective the tools that we're using are. If we don't invest in that research, we'll never understand if the restrictions that we're placing on drugs work or don't work. And the nation invests sorely little money compared to basic research in understanding how effective these steps are.
I want to leave you with this slide, which is what do we think in FDA are some ways that we can improve the adverse event reporting system? Now, these recommendations or these ideas aren't necessarily focused on simplification, which is I know what you're interested in. But the first -- it could easily be taken to that step. The first is that we think the real money in adverse event reporting-- I don't mean actual cash. I mean the progress, the important data. What we really want to focus on is serious events. We don't want a system where every time a child has a rash from taking an antibiotic, a mild rash, if we get snowed with tens of millions of these reports, it's not going to really advance public health. So we want to know about the serious events.
The next important aspect here is that we need high quality and complete reports. We need ones that have the detail that enable us to see whether the adverse event report is real, whether it's unexpected, how serious it is, that we can do medical follow-up to find out what happened to that patient afterwards.
We think there is a big gap in pharmaceutical reporting from health care facilities. MedSun has done a fabulous job of including facilities, but drug adverse reporting really doesn't focus very much on getting facilities involved. And one idea is expanding MedSun to drugs so that we have intensive, the same sort of intensive interaction in some facilities with our system as we have for devices.
And the last concept I want to leave you with is that it touches on the information technology recommendation that we received that by linking, directly linking, our adverse event reporting to computerized medical record keeping systems, which are the way of the future, as you all know, we can get reports in an automatic way that don't require a lot of intervention of new funds and new efforts. And eventually we think getting these reports automatically through these existing systems is going to be the way to go.
So I think I finished just about on time. I don't know, Dr.Wood, if there is any time for me to take direct questions or --
DR. WOOD: We do have time. Are there questions from members of the committee for Dr.Galson? Dr.Dennis? You have to keep the button pressed down, by the way, when you're talking. That's your incentive to keep it shorter.
DR. DENNIS: That was an excellent overview. Thank you very much. Very enlightening. But all these things that you mentioned, they look great. The question is are they all budgeted, or are these things that need to be built out in the future?
DR. GALSON: Yeah. Well, there is some things that cost money, and there are other things that require-- the computer is beeping here, so whoever is in charge should come and take care of it. It's not me. I'm not beeping.
Many of these things can be done with existing resources; but for us to have a major step forward in adverse event reporting is going to require both resources and a new level of interaction between the agency and provider, providers and health care, different players in the system. Health care organizations, professional organizations. So I don't mean to say that we can't do anything with those funds, but there are certain parts of this that do require funds and certain parts that don't.
DR. WOOD: MissEvink?
MS. EVINK: Thank you. The Best Pharmaceuticals for Children Act requires the toll-free number, I understand. How is that burden-- or do you see that that burden needs to fall to the retail pharmacy level, or what's the best way to promote that? The toll-free number, does it need to be promoted directly to consumers? Is that also part of the act?
DR. GALSON: Yeah, part of the act there, too, as I mentioned, it could be seen as conflicting; but we see it as a challenge, of course, in the agency. We have to do it in a way that it is very available to consumers, and we also have to do it in a way that reduces the burden as much as possible on pharmacists. But there is no question. We can't do this without some burden on retail pharmacists. It's not going to be possible.
We have different options to try to minimize it, and we hope in the end there will be enough flexibility so that pharmacists and the groups that pharmacies work with to get this sort of patient information that pharmacies give to patients, it's usually not prepared in the pharmacy. There are organizations that send that information to pharmacies to have them give it out to patients. So hopefully we can reduce the burden as much as possible, but we won't be able to eliminate it.
MS. EVINK: And as a health care practitioner that routinely, I routinely report adverse events.
DR. GALSON: Great.
MS. EVINK: In my capacity as a hospital pharmacist. However, you know, most of my reports are to the companies --
DR. GALSON: Sure.
MS. EVINK: -- because I'm trying to ascertain if it's a known serious or new serious event.
DR. GALSON: Right.
MS. EVINK: And one of the challenges of that reporting system that I've certainly had and my colleagues voice is making sure that the information that we give to them is complete, without completely burdening us in medical record research.
DR. GALSON: Right.
MS. EVINK: Because to identify co-morbidities and -- well, all of the things that come into that reporting. So I see that as one of the major challenges of expanding that system as you said with the rash.
Another major challenge that I have, and I don't know if you would care to speak to this. Another major challenge that I perceive is that what one of the important things that I tell my patients is if you're experiencing something, please contact me, so we can first take care of you and then take care of the larger, you know, then care of reporting. Because the most important thing is that the patient gets attention, especially if it's a serious effect.
DR. GALSON: Absolutely.
MS. EVINK: And how do we make sure that the patient is going to get that attention if the information is being directly communicated to the FDA?
DR. GALSON: Well, you're really making comments that are excellent. And, of course, care of the patient comes first. But we're not going to get high quality reports into the agency without involvement from practitioners at all levels. And with the time pressures on practitioners at all levels, we know this is a challenge.
We think some of the systems as medical records become more automated, we think there is going to be some real opportunities. And hopefully with this idea like the common data portal that I mentioned, by reducing overall the paperwork reporting of people in health care settings, maybe we'll free up some time for people to be able to spend more time getting the quality in the reports.
MS. EVINK: And in that reporting process then one of the things like when you call Dial-a-Nurse or Med-a-Line or something, one of the first things that you hear is, "If this is an emergency, dial 911."
DR. GALSON: Right.
MS. EVINK: So built into this will there be a system where patients will be encouraged to seek their local practitioner, make sure that their local provider is aware of the effect?
MR. GALSON: Right.
MS. EVINK: Because I can't imagine the FDA is going to be able to turn around reports quickly.
MR. GALSON: We do not have the capacity to act in an individual capacity with specific patients on their problems. So we're going to put a caveat next to the 800 number saying, you know, don't use this number to report for medical attention. And, of course, when we put out this interim rule, we'll get comments. Maybe we have to shift exactly that message, but we're coming, we're working on ideas on how to communicate that this number isn't for specific medical attention. You need to go back to your practitioner.
DR. WOOD: Miss Shafer? Thank you.
MS. OSBORNE SHAFER: I appreciate the focus on the serious adverse events because I think that's really what's going to help us here. However, I have an example that I would like your thoughts on. My state Medicaid drug program is refusing approvals for brand name medication unless evidence of a MedWatch has been filed.
So my concern becomes then either we're going to get, you know, an enormous volume of probably non-necessary, you know, reports of side effects to the FDA; or that it's a way to really limit appropriate access of medications and a physician's discretion on whether or not a brand is needed, unless the person has a serious adverse event, such as they die or they're severely hospitalized.
MR. GALSON: You mean they don't allow the brand name unless there has been an adverse from a generic? Is that what you're saying?
MS. OSBORNE SHAFER: Yes.
MR. GALSON: Oh, interesting.
MS. OSBORNE SHAFER: And so, you know, the question was were you aware of it and is this an appropriate use of this? Or do you have any other comments for me on that?
MR. GALSON: Well, I don't want to comment on the specific. I don't know if you're thinking about a specific patient or something. But in general from what you've told me, it doesn't make much sense because generics are the same in terms of it being bioequivalent, acting the same on the body. There shouldn't be an adverse event from a generic that you don't also get from a brand name drug. And if there is, we need to know about it immediately because it means that there is some sort of defect. So it doesn't-- that doesn't make a lot of sense, what you've just told me.
DR. WOOD: Go ahead. Follow-up.
MS. OSBORNE SHAFER: My follow-up there I think is just on the practicing providers. When you have drugs with narrow therapeutic indices, you do see some differences. And, you know, I'm using epilepsy as an example. So a lot of the neurological disorders are clear here, that there can be differences between, you know, effectiveness and emergence of side effects. And that's where we get into a dilemma of the appropriate use of this and managing patient safety and their access to appropriate treatment.
MR. GALSON: Yeah, there is some difficult questions there. I think one of the things that people sometimes miss is that, you know, every pill, even a brand name pill, they're not absolutely identical. The agency allows a certain degree of variation in manufacturing potency for all of our products. They're not absolutely identical.
They may be therapeutically equivalent, but they're not identical. And so those differences are present with brand name drugs and with generic drugs. But we know there are some special cases where people have demonstrated that they think there are real differences, but we think they're extremely rare.
DR. WOOD: In order to hear the panelists we have with us, it will be necessary for us to move on. So, Dr.Galson, thank you very much.
DR. GALSON: Great.
DR. WOOD: I would like to begin the panel discussion with Dr.Steven Meisel, who is a Doctor of Pharmacy and assistant director for clinical services at Fairview Southdale Hospital here in Minneapolis.
DR. MEISEL: How do I find the slides? While I'm getting this thing set up, I'm no longer in the position that was just announced. I'm director of medication safety for the Fairview Health Services for the metropolitan area here. There we go.
I want to start off by thanking the committee for inviting me to speak today. And I also want to make some comments that, you know, the FDA is often criticized from the one side for acting too quickly to remove a drug from the market or to put in a restriction and at times to react too slowly to that. And I think the fact that you're getting criticism, the FDA gets criticism from both sides pretty equally probably attests to the fact that a pretty good job is being done. I don't hear anybody who's too neutral on that, and that's probably a good thing.
I also want to agree wholeheartedly with everything that has just been said. There is nothing that I can find to disagree with about the current adverse event reporting system or the direction of the FDA or anything in that regard.
The one comment that I would have, though, about the current data is that data seems to be a one-way street. Practitioners report data, but to get the data out is like pulling teeth. If I want to know if there is a serious rash of problems with Drug X, I've got to file a Freedom of Information request. Two months later I'll get this little microfiche thing to try to find a reader to put under, which, of course, nobody ever seems to have. And you kind of lose interest after a while.
If we could have a sort of two-way repository of data where I could enter data on-line into some sort of a data base. Then I could also query that data on-line to find out what the issues are and how often they appear and so forth, that would be of tremendous benefit to practitioners such as myself.
I do want to make some comments here about some areas that I think the current regulations fall short in terms of improving safety. And I don't mean this to be terribly critical because the FDA does a very good job in all sorts of areas, and to some extent I know this committee is interested in simplification. What I'm going to be talking about here is they appear to be increased regulation. So I think it's very important.
The first has to do with labeling. And there are four issues with labeling. One is plastic vials, skeletal muscle relaxants, look-alike packages and non-standard label formats.
Here is an example of what I mean by plastic vials. This is a local anesthetic. This is a bronchodilator. I have no idea what this is. And here is the back of them. Okay. Embossed lettering on here. These are labels that are made to be confused and made to be misused, and nobody can read the darn things.
Here is Albuterol, a bronchodilator. Another bronchodilator, Epitropium. These are I think other drugs that are similar to that, but you don't really know.
If you look at a respiratory therapy kit, this is a disaster waiting to happen. The fact that embossed labels are permitted at all on these sorts of packages is a disgrace. These are disasters waiting to happen. It's only a matter of time before somebody gets hurt. I know that the FDA is concerned that the glue may penetrate the plastic, although it apparently doesn't appear to be a problem in this case. But if that's really the case that they're worried about, you can also put some paper labeling over the hub or whatever you call that piece of it, so that everybody can read exactly what the product is.
Skeletal muscle relaxants. There has been a proposal on the table for some time that skeletal muscle relaxants all have a standard label or wording on the rubber stopper. It says, "Caution, Paralyzing Agent."
We had some problems with potassium chloride back in the 1990's, and we fixed that problem. The FDA helped to fix that problem by mandating certain types of packaging requirements for potassium chloride. We have similar problems with skeletal muscle relaxants. Some of them have this very nice warning, "Paralyzing Agent" on the rubber stopper, but there is no requirement for that. And it's all over the map in terms of what you see out there.
And there are cases after cases after cases where patients are given a skeletal muscle relaxant intending to be given something else. FDA ought to have a regulation for highly dangerous products like skeletal muscle relaxants that standardize the kind of labeling that we're talking about.
Standard label design. The product on the left is a muscle relaxant. This is a diuretic. They look alike. The same manufacturer, same color cap. Same color is on the label. Same size of the vial. And these two drugs have been interchanged, and there have been recommendations on the table from all sorts of outfits to standardize coloring and so forth to prevent these things from happening.
Chlorpropamide for diabetes. Chlorpromazine, an antipsychotic. Both a hundred milligrams, both from the same generic manufacturer. It's easy to see how these could be mixed with each other on the shelf. Somebody could put something back in the wrong bin, pull something from the wrong bin, and you could wind up with a disaster. And these things happen all the time. Again designing these labels in such a way to improve the utilization so they don't get misused.
In your hand-out material I've got photocopies of these labels. I couldn't get them onto a slide very well. Some of you locally may remember Toby Lee, who was a six-year-old boy in Hutchinson, Minnesota, who died in December of 1999 from an overdose of Cerebyx, the third death from this drug that was reported to the manufacturer.
Resulting from label confusion. The nurse thought this was 50 milligrams in the vial, as opposed to the 500 milligrams in the vial because of the way the label was designed. Three people died before they changed the label to this, 500 milligrams and 10 m/l. Since the time they changed that label in the year 2000, there hasn't been one overdose of this drug. It is two years ago.
Why do I put this up? We have drugs on the market today with the same labeling problems. Same labeling problems, causing the same kinds of medication errors. This particular drug has been -- it says 100 milligram per mill on the top. The fact that's a 2 1/1 mill vial is down here. In an emergency setting, somebody wants to give 300 milligrams, they give three vials.
Those cases are reported time and time again because nobody seems to have learned the lesson, and the FDA doesn't have the standards in place to require the right formats and labels so that these sorts of things can't help anymore. It happened with Cerebyx. It happened with other-- as soon as they changed the label to something else, the errors go away. Why can't we learn from that and put in some regulations about labeling that are standardized to prevent these from happening?
Minicin, 50 capsules of 100 milligrams. Minicin, 100 capsules of 50 milligrams. Again, errors waiting to happen.
You might think these are really two pictures of the same exact box, but they're not. This one says 63602 and 63603. There is one other difference. Over here it says for neonatal use. And up here it says a half a mill. Here it says one mill.
There are no standards for labeling to help us to prevent these kinds of errors and adverse events. And it wouldn't be hard to create these kinds of standards that would improve dramatically patient safety.
Nomenclature. We already heard about some efforts with nomenclature. And I want to applaud the FDA for some attention to tall man lettering, which is a recent initiative and to try to prospectively identify labeling problems when they do take place-- or I'm sorry -- nomenclature problems. But I know that there is only so many ways you can put together-- there is only 26 letters in the alphabet, and there is only so many ways you can combine them in a way that's pronounceable. I understand that. However, there are still issues with look-alike and sound-alike names and with suffixes. We know about Celebrex, Cerebyx, Celexa.
Let's not forget the herbal remedies when we talk about nomenclature confusion. We talked legend pharmaceuticals, but we have a tendency to forget about the herbal remedies. So herbals, nutritional products and so forth should be considered, along with the rest of the labeling, rest of the nomenclature.
Suffixes. ER, CD, SR, XL, XR. Who knows what these things are supposed to represent? Okay. Or maybe even worse, Paxil, Paxil CR. Both of them are once-a-day products. Both of them are once a day. And can anybody tell me what the difference is between Vicodin ES and the Vicodin HP are supposed to represent?
There needs to be standard definitions for suffixes so that everybody-- just like in food industry, so everybody understands what light is in foods or what low cal or diet or whatever is in foods, we would have standards by which we understand what ES, HP and XL and XR and CD and all these sorts of things are. Otherwise it drives people crazy and leads to medication errors and adverse events.
DR. WOOD: Dr.Meisel, can you please wrap up?
DR. MEISEL: I am. I have just a slide or two more. I want to make the comment that I think the oversight, both within the FDA and the pharmaceutical industry, is sometimes separate between product defect and adverse experiences. I think they're part of the same continuum and should be combined. So that the issues I just talked about can be looked at by the same people in the same way.
And I think that's-- and we need to be reporting bar coding on products, and I'll leave it at that. And if we have time for questions, we can talk about drug shortages and what that does to supplies and medication errors. Thank you very much.
DR. WOOD: Thank you. Next I would like to welcome Dr.Herbert Slade, who is the medical director at 3M.
Let's have Miss Debra Shader -- Dr.Shader is a senior researcher at United Health Group -- to share with us her insights.
MS. SHATIN: I'm pleased to be here before the committee to provide background on an initiative of interest to this committee, the CERTs, the Centers for Education and Research on Therapeutics, which Drs.Galson and Wood described.
You may wonder why am I presenting. I'm at United Health Group, the Center for Health Care Policy Evaluation. And I think it's an excellent example of the public/private partnership in that we work with the University of North Carolina, which focuses on rational therapeutics for the pediatric population. We're also an FDA cooperative agreement site for post-marketing drug safety surveillance.
As Dr.Galson presented, the vision includes to be a trusted national resource for people seeking to improve health through the best use of medical therapies. And the mission is to conduct research and provide education to advance optimum use of drugs, medical devices and biological products.
There are several ways that this mission is accomplished. First, through developing knowledge about the best use of the therapies. Second, to manage risk and benefit by improving the ability to measure risks and benefits of therapies used in clinical practice. And we all know there are big differences between the populations in clinical trials and out in the real medical community of treatment.
Another set of activities is improving practice by advancing strategies to ensure that therapies are used always and only when they should be. Finally, to inform policy makers about the clinical signs and effects of current or proposed policies.
This is a unique initiative in that it links government agencies, academia, pharmaceutical and other industries, health insurance, health providers. The goal is to improve effectiveness and to decrease costs of pharmaceuticals and other therapies. And here you see the overall structure.
As mentioned earlier, these CERTs were mandated through the FDA Modernization Act, but funded through AHRQ to keep the regular choice separate from this service. There are seven coordinating -- seven different sites around the country, and the coordinating center is one of the sites at Duke University. There is a steering committee and then a number of work groups including public/private partnership, methodologies, data and the web.
So the FDA faces critical needs in pre-marketing drug approval and post-marketing surveillance. We will rely on the CERTs to provide research data and professional expertise such as risk workshops. AHRQ is the sponsor of the CERTs program and aligned with NIH, FDA. As you can see, there are a number of different groups. Consumer coalitions, professional organizations. And it's to provide support and guidance for this national resource. AHRQ itself, its mission is to support, conduct and disseminate research that improves access to care in the outcomes, quality, cost and utilization of health care services. It's quite a mandate in terms of health care.
The CERTs sites are Duke University, the HMO Research Network, University of Alabama at Birmingham, University of Arizona Health Sciences Center, which formerly was at Georgetown. University of North Carolina, University of Pennsylvania and Vanderbilt.
The coordinating center, which is at Duke, has a number of responsibilities, including administering the committees, coordinating across research sites, enhancing synergy across the centers and agencies. And I think this is really critical because the whole is greater than the sum of the parts. Rather that these disparate academic institutions in public and private partnerships, what we're seeing is quite a synergy. An example that I'll show later is through risk management workshops.
I thought it would be helpful since there isn't time to talk about the research of each of the CERTs to provide instead examples of types of studies that deal with therapeutic safety. First, in terms of causal research, one example -- and this is at Arizona where the PI is Dr.Greg Mosly -- the study is looking at use of FDA and PBM data bases to identify candidates for investigations of drug interactions.
The overall focus of this search is reducing drug interactions, particularly in women, and also clinical pharmacology. An example of interventional research would be the University of Alabama improving adherence among users of estrogen and other anti-porosis medication. The PI there is Dr. Ken Sag, and the focus is on musculoskeletal disorders. So you'll see that each CERT has a unique focus, yet there are important ways for interaction.
Translational research, which is very critical, how do we translate the research that's done into clinical practice? One example is at the University of North Carolina who developed a new adverse drug event reporting tool and systems- based analysis of likely sources of medication errors.
And then an example of education, which is also quite key, it's a CERT, Center for Educational Research on Therapeutics, is the education of patients and physicians about the benefits of beta-blocker use in heart failure. This is being conducted at Duke University where the PI is Dr. Judy Kramer, and the focus is on cardiovascular medications and devices.
I'll briefly mention a series of think tank programs that have been designed to improve and develop the research agenda. These have included risk communication; risk benefit; benefit assessment; the role of the media in this communication, which we've seen just increasing steadily; and risk management. These workshops include representatives from industry, FDA and academia; and they're integrated with other ongoing efforts.
And I was honored to be able to attend the most recent workshop, which was on post-marketing assessments of pharmaceutical risk, which I think is of key interest to this committee. This was held in North Carolina about two weeks ago, and it's a working group, so it's people representing various perspectives and areas of expertise.
And this is just the beginnings of a working paper. Each of these series of workshops will be published and the information disseminated. Among the recommendations and assessments of gaps in knowledge include how do you determine the best practices to obtain the signals from the spontaneous reporting system and determine which are two signals that need to be tested in larger data bases where you have a denominator to work with?
The secondary is methodology development. Third, the actual biology of adverse events, which would help in determining the causability of particular adverse reactions that are reported. And then as Dr.Galson mentioned -- I think this is starting to happen -- the link between pre-approval and post-approval safety study programs. Up until now they have really been separate.
Another area for research is pre-market assessment and pro-active risk management. I think we're starting to move in that direction as well.
And then research in the area of what is acceptable risk and uncertainty? Every medication, every therapy used has benefits and may also have a risk. What is that balance, and what is tolerable? And then finally in the area of education.
So in conclusion, the CERTs are a valuable national resource for issues regarding therapeutic safety and public health questions such as adverse event reporting. The CERTs represent a public/private partnership that is playing a leadership role in therapeutic research and provides an opportunity for the synergy to address issues that might be raised by this committee. Thank you.
DR. WOOD: Thank you very much. We'll go back to Dr.Slade.
DR. SLADE: Apparently the disc was sent with the paper copy for photocopying. Well, let me begin while this is loading. Chairman Wood and members of the committee, thank you for the opportunity to participate in today's hearing. I would like to make a few points about adverse events and then two recommendations.
Let me begin by pointing out that any chemical, including oxygen and water, will be toxic at some concentration or dose. It is incorrect to think of some drugs as safe and others as unsafe. The question is whether and how a drug can be used relatively safely to obtain certain desired beneficial effects.
Undesired effects or adverse events fall into categories. So-called Type A reactions are those which you would expect to find described in drug labeling at the time of marketing. They occur commonly and are related to the pharmacologic properties of the drug. Type B reactions are unlikely to be recognized as far as a drug group. They could be very serious, but they don't occur very often and are difficult to predict. These are the ones that typically generate the greatest concern.
Drug safety testing begins many years before the first human exposure with the examination of molecular interaction. For example, enzyme interaction. From there testing moves to cells and culture to bacteria for gene toxicity and eventually to animal testing.
Human testing is undertaken in phases with Phase 1 focused on the examination of adverse events across a range of doses, dose frequencies and dose durations. As you know, only about five of every five thousand potential new drugs make it to this stage. And only one makes it to licensure.
We cannot detect all uncommon adverse events during pre-approval drug development. The reason for this is straightforward. By definition, uncommon adverse events occur at a frequency between one in one hundred and one in one thousand. Current regulations require that we expose 1,500 subjects during development. This gives us a chance to detect adverse events having a true frequency of one in five hundred.
What about events with a true frequency of one in every one thousand patients? According to a statistical principle known as the Poisson distribution, the probability of observing such an event in a single clinical study of one thousand subjects is only .37 or 37 percent.
Stated another way, we would need to have about three thousand patients in our study to be certain of seeing one occurrence of this particular adverse events. Even if such a large study were undertaken, it is unlikely that this one adverse event among three thousand patients would be immediately recognized as causally related to the drug. Because sound scientific methodology demands that each clinical study have a narrowly defined objective, it is not unusual for a drug development program to include thirty or more clinical studies, requiring a large study. A large number of very large studies would most certainly impede the drug development process.
The safety margin described at the time of drug launch is, therefore, established on the basis of common adverse events and thus arises the need for post-marketing adverse event surveillance and risk management.
The number of patients using the drug post-marketing is large enough to allow uncommon and rare adverse events to become apparent. And this is where we have an opportunity to improve our system.
My first recommendation concerns peri-approval studies. The pre-FDA meeting should be used as an opportunity to discuss risk management and outline peri-approval studies which address specific areas of concern. More importantly, such studies are often recognized as desirable under current procedures at agencies worldwide. But lack of agreement between agencies on issues of design represents an impediment. Harmonization of requirements for these studies and their methodology will be beneficial. We have already seen post-approval adverse event reporting grow more consistent around the world, and this consistency is very important.
My second recommendation concerns post-marketing surveillance. It should not be assumed that post-marketing surveillance is a simple process whereby adverse events reveal themselves to be causally related to the drug and are then collected and counted. What is gathered consists of suspicions.
These represent both signals and noise. A signal here is an adverse event which is both temporally and causally related to a drug. Adverse events which are temporally but not causally related represent noise. Our goal is to find the signals by recognizing unique features by reducing the background noise or by utilizing some algorithm which results in signal enhancement. It is essential that any new regulations regarding surveillance be based on use of well-tested and validated methodologies.
The recently enacted Best Pharmaceuticals for Children Act requires the FDA include a toll-free telephone number in drug labeling as we heard this morning. Consumers today are most likely to contact the manufacturer directly. The manufacturers are well staffed and well motivated to document, assess and report adverse events to the agency.
We have dedicated professional staff who strive to contact involved health care professionals in order to obtain technically adequate data, which is subsequently formatted into a MedWatch form and reported to the agency. MedWatch reports can, of course, be made directly to the agency. In this system noise is reduced and the signal enhanced by having skilled observers report important details, such as test reports and diagnoses.
The required labeling change is intended to reach the broadest consumer audience. That is, consumers will be encouraged to call FDA directly. If the label change achieves only a doubling of spontaneous reports arising from consumers and directed straight to the agency, conservative arithmetic suggests that FDA will want to hire about 350 full-time staff to provide the same level of response offered by manufacturers today. And that arithmetic is based on my company, which is about the 70th largest, and we've got five staff, so this is very conservative.
Health care providers must be brought into the loop to provide technical data concerning the report and to provide health care advice which is often sought by the caller. To the extent that product performance issues are a part of the complaint, the manufacturer must be involved in a way which avoids any lengthening of the time required for product quality issues to be examined.
Will adverse event data flow in reverse from the agency to the drug manufacturers' systems? If so, system design changes may be necessary. If not, the manufacturers' medical and scientific staff, who are most familiar with the drug, will be left out of the communication loop.
What is needed is not only increased numbers of reports, but increased numbers of high quality reports. An increase in numbers alone will not necessarily improve the validity and utility of causality assessments, as reporting increases both signals and noise. A higher level of spontaneous reporting by and through health care professionals as occurs outside of the United States would improve the current system.
I recommend that new labeling should encourage consumers to contact their health care professional or the manufacturer or the FDA. We need to be careful here to reduce the likelihood of duplication in reporting, which may be accomplished, for example, by letting consumers know that manufacturers are required to convey all reports to the FDA.
In summary, we should seek to improve existing systems which are not intrinsically flawed. Earlier identification of risk management issues, more productive use of the peri-approval studies and enhanced numbers and quality of spontaneous reporting are desirable. The quality will continue to depend on a high level of engagement by manufacturers and health care professionals in partnership with the FDA. Thank you.
DR. WOOD: Thank you very much. Next I would like to welcome Miss Nancy Sailer, who is the director of program services for the Minnesota Dakotas Chapter of the Alzheimer's Association.
MS. SAILER: Good morning, Mr. Chairman, panel members. My name is Nancy Sailer, and I will present my experience today with adverse drug reactions from the family care giver or the consumer perspective. I know that your overall interest is in the health care barriers that can be overcome by changes in rules; and I will, therefore, follow with several vignettes with practical recommendations.
I'll begin with my own father-in-law's situation. In his late seventies a hip fracture required surgery and subsequent nursing home care. Once admitted to the nursing home, he was prescribed Halcion for his anxiety. Soon he was having hallucinations. Facility staff neither recognized this as a sign of trouble, nor did they respond to my repeated requests to discontinue the medication because of the side effects.
Most alarmingly, even after I managed to speak directly with the doctor, the new order was not written on his chart; and nursing staff continued to give the drug. With persistent advocacy, the drug was discontinued; and the hallucinations stopped. I recognize that this illustrates an adverse event compounded both by training and communication problems in the nursing home.
Most of the majority of the patients and residents do not have family who can travel a thousand miles and refuse to take no for an answer. The system has to be better.
My 83-year-old mother-in-law provides another experience. Medication prescribed for her arthritis zapped her energy and clouded her thinking, so she opted to accept the pain instead. I have encouraged her to report this, both to her doctor and talk with her pharmacist.
I see two issues in this case as well; the need for a full discussion of the pros and cons to the extent they can be predicted at the time of prescribing the medication and the value of recording these effects for future reference.
In my own father's case at 75 the implantation of a device used to administer his cancer medication left him with Type 2 diabetes. The answer to my inquiries was that the device was probably contaminated, not sterile, and that triggered the diagnosis. For the rest of his life he was insulin dependent with higher medical bills and permanently altered diet and lifestyle.
Lest it appears that these unfortunate events are the province of the elderly, I can tell you that I saw comparable problems in my husband's treatment with chronic depression. At a point where one ineffective medication was being replaced with another, an accidental error in self-administration resulted in hospitalization.
My groggy husband was in no condition to recognize the new medication the RN was about to give was a heart medication. He had never been prescribed heart medication. Upon my repeated questions, only then did she come to realize that the orders she referenced were for a different patient. The patient's name and the name on the chart did not match. Here, too, alarmingly poor quality of care complicated the matter.
Moving toward my recommendations, I urge you to make changes that reach the general public. I have worked as a social worker in long-term care facilities and services for over fifteen years. Yet even in the trenches, I was never taught about MedWatch or the need for adverse drug reactions to be reported.
Regulated health care facilities and services ought to have a duty to provide basic information about adverse drug reactions to their staff and consumers. Consumers particularly need information to overcome the likelihood that their observations will not be taken seriously.
First, basic consumer information and facilities and services. I believe a federal law and advanced directives provides a good precedent. Health departments with a summary of -- should write a summary of applicable state law. Certified facilities receive this resource from the departments. They provide it to consumers.
With this approach, the public sector could then generate the written summary of what an adverse reaction is, along with what, how and where to report. These resources should then be supplied to consumers via their physicians, facilities and services.
My second point relates to basic education for professional and paraprofessional care givers. I recommend that the department use rule-making authority to define and enforce requirements for physicians, hospital and long-term care staff to be trained to recognize their responsibilities for properly responding to and reporting adverse drug reactions.
In closing, I want to add that I direct the program services for the Alzheimer's Association, Minnesota Dakotas Chapter. I know that medications are an increasing part of managing this disease. With that perspective, I become even more apprehensive about issues of adverse drug reactions and lapses in the reporting system.
These and all patients have highly individual responses to treatment in general. And they are least likely because of their communication problems to be able to report on their own. Their families and other care givers need tools, and I encourage you to provide them.
Finally, I want to thank you for your time this morning and to submit in writing additional areas of regulatory recommendations to help people with dementia and their families. Thank you.
DR. WOOD: Thank you. Next I would like to welcome Ms. Kristin Johnson who is manager of quality and regulatory compliance at the Boston Scientific Corporation.
MS. JOHNSON: We've been talking a lot about pharmaceuticals. I'm actually working in the medical device area; and, of course, eye glasses are a good example of a medical device. I think I could use them right now. I'm kind of at that age.
I'm Kristin Johnson. I'm manager of the quality and regulatory compliance department at Boston Scientific, and I would like to thank the committee members for the opportunity to provide input today. Usually I'm on the other end. I'm receiving input. So it's nice to be able to pass that along, and I really appreciate that.
My professional experience has been in the fields of quality assurance and regulatory compliance, with eight years in the medical device industry, primarily Class 3 cardiology products. Also another fourteen years in the IVD business.
During that time with IVD business I've had very limited exposure to adverse event reporting, but the last eight years fairly extensive medical device reporting for medical devices in my current position.
My comments today are based on my own personal and practical experience. I did receive some other input from an MDR reporting center for Boston Scientific, but I can't say that I'm representing all manufacturers. And again my experience is with medical devices, not pharmaceutical reporting. From previous discussions that we've had, I think, though, that there is a great deal of similarity in the type of errors that can be made. And so I think my comments will be fairly relevant.
The use of adverse event reporting is one way to protect public safety and I think is seen by manufacturers as very reasonable and logical and important. Industry, manufacturers, companies, are a collection of individuals. And we basically wear both hats. We're often the consumer, as well as the producer. So we're just as interested in oversight and protection, I think as a consumer, as we are in fairness and efficiency from a manufacturing perspective.
Adverse event reporting may uncover product issues that may not be apparent until there is large amounts of data available. It may uncover product issues that even with manufacturing controls in place are not identified internally. And reporting might also uncover the use of devices in cases of complex procedural context that was not anticipated during clinical trials.
I was asked to reflect on what's going well with device reporting and then what can be improved. Well, there is lots going well. As I mentioned, the need, perceived need, for event reporting is very-well respected. Secondly, the detail, the standardization of forms and the detailed instructions on how to submit the forms and report them is working very well and is very much appreciated.
The use of alternate summary reporting on a quarterly basis also is very well-received and is a good, efficient means to report. The reporting time frames for medical devices was expanded to 30 days, and that I think is a real positive move because it provides additional, more accurate and complete information at the time of reporting. And lastly, the MedWatch office that we work with in Washington has been very helpful and very responsive. So again a lot of positive things from the manufacturers' perspective.
Areas for opportunities are broken down into a number of different areas. First of all, the areas that could be looked at to optimize resources required to report and analyze data. These are really ideas for efficiency.
The first area is to really look at malfunctions. From a manufacturer's perspective, we-- and being in regulatory, we come from a very conservative background. You know, it's different from company to company. But many companies are very conservative. And I think from the standpoint of reporting malfunctions, the bottom line is I think many companies over-report to be sure to cover themselves.
That is an awful lot of data to collect and catalog, and I'm not sure that it's really valuable and useful. So from the standpoint of reporting malfunctions, I would take another look at the definition benefit to see if really there is actual evidence that this information is being used and helpful.
The next area for efficiency improvements is manufacturers highly, are very positive in the area of electronic reporting. We're still doing a lot of faxing and manual duplication of efforts, so I think there is an area that is definitely an area of improvement yet.
Another type of area to look at is areas where the expected value or perceived value is not being fully achieved. And this is in the area of user facility reporting. Our facility receives only a small fraction of what we would expect to receive from user facilities as far as the MedWatch form. And the MedWatch form does provide more detailed and accurate information than information over the telephone. So again we're only receiving a fraction of the user reports, user facility reports, that we would expect to receive.
Another area of opportunity I think is in the area where the purpose, benefit and value of reporting is unclear to manufacturers. The area here that I see that really stands out to me is in the area of baseline reporting. Baseline reporting is where the manufacturers provide model information, approval information, expiration dating or useful life. And that has to be reported, along with the MedWatch form and then updated annually.
The purpose and value of this has not been communicated to manufacturers clearly. This is perceived from my perspective as busy work. And there is an awful lot of follow-up because we're trying to match letter for letter, word for word, the exact information that we have so that there is a match.
The next area and several other ideas I would have for the committee to look at would be it's not clear to manufacturers with all the reporting that's going one direction, how is that information actually analyzed? What methods are used? What criteria are used as flags? And I think if manufacturers had that information, we could do that ourselves.
We wish to be pro-active. We wish to take care of issues where they exist. What we don't know is at what point is there an issue? At what point is the line crossed? What is the criteria? So that would be very helpful for manufacturers to know.
Trending and analyzing this data is not a clear-cut science. It takes a lot of knowledge, and I think manufacturers are in a really good position to do that trending and analyzing themselves.
The last idea is more about a smaller point, but I think medical device and maybe pharmaceutical firms would appreciate having separate MedWatch forms. We tend to have the feeling that we're trying to, as medical device manufacturers, trying to form fit information into a form that was really designed for pharmaceuticals. It can done, but what makes it very difficult is the interpretation of certain fields, and the coding is very difficult. It's hard to match up a device malfunction with the codes that are there.
So in closing then, like I said, I've mentioned a lot of positive things; the usefulness and definitely the manufacturers are willing to do adverse event reporting. But on the other side, the opportunities are the focus on serious injuries, efficient use of data, transfer of data, the process of baseline reporting, whether that can just be eliminated and pertinent information be placed on the MedWatch forms, all are some ideas that I think would maybe streamline the process without compromising the benefits. Thank you.
DR. WOOD: Thank you. We have a very small amount of time for questions, but we'll try to accommodate as many as we can. Dr.Dennis, did you have something from earlier?
DR. DENNIS: Let me go back.
MS. GIGLIOTTI: Dr.Nelson, I have a question for you. I and other committee members live in states that border Canada. And when you were giving your presentation, I recognize that it presents an extra challenge especially with adverse drug events and not having continued relationships with providers and pharmacists, etcetera. But there also seems to be a lot of misinformation about FDA regulations regarding bringing in drugs from other countries, etcetera. Could you please clarify laws regarding that?
DR. GALSON: I don't think so, no. That's a totally different subject.
MS. GIGLIOTTI: I know.
MR. GALSON: Right. And I'm actually not an expert on the regulations of drug import and re-importation, so I would rather just not comment on that. I would be happy to try to get you the most up-to-date information on it, if you give me -- I'll get your card or your number.
MS. GIGLIOTTI: Yes, thank you.
DR. WOOD: Jeff?
MR. BLOOM: Thank you, Mr. Chairman. I actually had questions. One is for Dr. Shader. Thank you very much for your excellent presentation on the CERTs. And I'm only sad that Congress hasn't allocated the money that was originally supposed to be allocated to you to do the fine work that you do.
But one of our proposals that Dr.Galson touched on that we're going to be talking about later today or tomorrow is about using the CERTs to be a repository for adverse event information that's out there that we simply do not collect now, such as on our committee we have Heidi Margulis from Humana that has a great data base with all their patients with all the adverse drug reactions that they have, as well as allergies and things like that.
And the idea behind it is because you do have such good public/private partnerships and have both those things, whereas the FDA is somewhat seen as an oppositional thing at times with the industry, the thought was that you could possibly do this and work with the FDA in combination. It wasn't to cut out the FDA reviewers. It was obviously the main reviewer of the drug and has the most information.
I was wondering if you felt like that was something that the CERTs could possibly do and are equipped to do, with the understanding that you receive additional appropriations, obviously?
DR. SHATIN: Just to correct the record, it is Shatin rather than Shader. But I think that is an interesting idea. Something that hasn't been mentioned today is HIPAA, and I see very big issues in terms of linking of data bases. The cooperative agreement sites are one vehicle where signals are raised. Large data bases can be looked at to determine whether it's really a true signal or not. We have information.
I think an issue there is over the past ten years it's been at the same level of funding each year. And, in fact, where there used to be five sites, there are now three sites throughout the country. So I think you're raising a very important point.
MR. BLOOM: Thank you. The second question is to Dr. Galson, and that is in terms of the mandatory reports to you, how successful is that? And if you had to guess, how many manufacturers are actually filing the reports that they're supposed to be filing?
DR. GALSON: We think it's pretty successful; and, in fact, we do go out and inspect when there is a question or a complaint. So we think that part of the system is actually working pretty well. I'm sure there are things that fall through the cracks, but we think in general it's working pretty well.
DR. WOOD: Miss Margulis?
MS. MARGULIS: Thank you, Mr. Chairman. I would like to give Dr.Galson an opportunity to respond to some of the labeling issues brought up by Mr.Meisel, if you will.
DR. GALSON: Yeah. Well, first of all, I asked him to get me a copy of his slides because I hadn't heard about all those examples before. I think he brings up really excellent points. The challenge that we have in regulations on labeling is that manufacturers in general don't like them. They want to be able to label their products the way they want for various reasons.
And so what we try to do with these regulations is set up what we think is a floor of requirements that will avoid problems. But as the industry evolves, there will be new kinds of products, new ways of packaging. And when we find out about problems -- and the one that I hadn't seen before was this problem with the embossed, those clear packages -- I think we really need to do something about problems like that when they're pointed out to us. So I think our regulations have to evolve with the packaging as well.
DR. WOOD: Dr.Dennis, upon your reflection?
MR. DENNIS: Yes, actually, believe it or not, my questions have been partially answered. Initially they were to be addressed to Dr.Galson, but I'm not sure whether he can respond to them or not, but feel free to respond as well. What I was wondering is the information that is collected by the CERTs, how is that information made available to the public? Was it something that goes directly to you and then somehow it ends up in some format? Because it seems to me a lot of valuable information. That's different than integrating information from the various CERTs.
And then the other question is it sounds like the level funding has resulted in shrinking the program because you go from five centers to three, that's usually an issue related to funding. Or the other issues or just a plan to downsize it when it sounds like that's exactly what's needed in order to address the patient safety issues identified a lot of the post-marketing kind of issues that come up that need to be addressed.
DR. GALSON: I'll give a brief answer to that. You can probably give more answer. In terms of communicating what the CERTs do, there are a number of different ways. They publish in the medical literature. They certainly -- we have very close communications with FDA, so they have the most communications with us.
We hear about what they're doing and try to incorporate their findings, but in general I think you're making -- I think Jeff is holding up a report. You're making a very, very important point; that when we do get new information in how to protect patients better or how to avoid errors, how is that information working back into the regulatory process to change the way we do business? And I think as a manager of a big part of FDA, that's a big challenge for us; and that's something we need to do a better job on.
DR. WOOD: Any others? Go ahead.
MS. SHATIN: As Dr.Galson mentioned, there are the reports, each of the annual reports. There also is a web site with a wealth of information about the various publications and what the different CERT sites are working on.
Also, I think I should clarify the record. There are two separate programs. The CERTs is one program, which is mandated through the FDA Modernization Act. There are currently seven sites. The FDA cooperative agreement is a completely different vehicle. That's through the Office of Drug Safety of FDA. And I think there is seven sites currently for the CERTs. I think there may be-- it might be possible there could be future funding and that additional topics covered as well.
DR. GALSON: In general, we've been very constrained in our funding having to do with post-marketing work. But we have tried to maintain the level that's needed. With the new Prescription Drug User Fee Act, we'll be able to spend our user fee resources more on post-marketing, so that should really improve the situation.
DR. WOOD: Mr.Fay?
MR. FAY: Thank you, Mr.Chairman. Dr.Galson, from a facility perspective -- I'm with a hospital company -- it would seem to make sense especially now that we're in the 21st century that we would be able to pick up a vial or something like that and it would have a bar code on it. And we could wand this bar code, and it would clearly contraindicate this drug for a certain kind of patient or clearly flash a warning.
But I sense that one of the big impediments to that is none of the examples that were put up on the screen included any kind of a bar coding system on those drugs. Are there any plans to do that in the future?
DR. GALSON: Yes, there are. And, in fact, we're working on a bar coding rule; and I can't talk about the details of it because it's not yet promulgated or put out for the public. But we have a group of staff in the agency that are hard at work on the rule, and it's a priority of Secretary Thompson. And he's directed us to move forward on it, and we are.
DR. WOOD: MissShafer?
MS. OSBORNE SHAFER: This is for Mr.Meisel. You had alluded to concerns regarding drug shortages that affect patient safety, and I'm wondering if you have any brief comments and recommendations for solutions in this area?
DR. MEISEL: Yes, thanks for bringing that up. I'm not sure why, but over the last few years drug shortages have become an immense problem, and I'm sure it's multi-causal. I can remember when we had a problem getting Fentanyl, a narcotic used in anesthesia, for a while a couple years ago. And the people started using Sufentanyl, and nobody knew how to dose that, and we had all sorts of dosing errors with oversedation with that product.
Other examples where you can't get 50 milligram sizes, so you get 1 gram sizes of something or other, and you kind of send them out. And people don't realize it, and you wind up with mistakes happening that way.
I don't have any answers for this obviously, other than to try to work to prevent the shortages in the first place. But if the FDA could do something to help us be alerted when these shortages will happen and to work on some standard responses, what drugs ought we be using instead, how to educate the practitioners on what might be and so forth, that would be very helpful.
The other thing that winds up happening is when you can't get something, you wind up with these mom-and-pop pharmacies making products sort of in their garage. And that's sort of a flippant overstatement, but you never quite know where they're coming from. We get fliers all the time from the pharmacies, compounding pharmacies, from all the over the country saying, "Well, you can't buy it, but we'll make it for you," some injectable product or something. And I'm not aware that there are any good standards out there to ensure us that if we were to buy this that it would be safe and effective and legitimate.
DR. WOOD: Thank you. I want to thank the panel members for their time and presentation this morning. It gives us a good framework on which to proceed. We will take a ten-minute break and convene promptly again at five minutes to the hour so that we may begin public comment.
(Break taken at 9:45 to 10:05 a.m.)
DR. WOOD: Can I please invite the committee members to come back to the table so we can begin public comment? As the committee members are coming back together and we prepare to begin the period of public comment, let me remind the members of the audience who will be making comments that we will ask your patience as well as your understanding. We have many more people who have requested time to comment than there is time available in the agenda. And so I'm going to try to make as much additional time as I can in the agenda by managing some of the time that we have for committee work and devoting that to public comment instead of committee work.
But in addition to that, I'm also going to ask that each of you limit your comments to four minutes so that we can give everybody a chance to speak. There is a light system that we have that is here on the table. And so when you see the yellow light, it tells you that your time is about up; and when you see the red light, it is time to stop. And I will ask you then to stop when the red light illuminates.
We have a number of people who have signed up for this morning. We may need to carry some of those into the afternoon, and we'll try to do as much as we can this morning without having to carry it into the afternoon, but it may be necessary.
I would like to begin by inviting Mr.Bradley Thompson. Mr.Thompson? Okay. Then next would be MissDebra Jensen. The next person I have is Dr.Steven Norsted. We are speaking very rapidly here. The next person is Mr.Ken Manning. MissCnythia Joyce. We must have actually covered everything that you wanted us to cover, actually. Next MissJill Egan? Good morning.
MS. EGAN: Good morning. Good morning, and thank you for the opportunity to comment. My name is Jill Egan, and I'm the senior vice-president and chief operating officer of the Minnesota Hospital and Health Care Partnership, the trade association representing 139 hospitals here in Minnesota.
Your morning session on adverse event reporting is a topic the hospitals in Minnesota have pursued with great care. The observations in the Institute of Medicine's report "to err is human" galvanized the efforts of Minnesota providers to improve patient safety. Culminating over two years of development, Minnesota hospitals are now voluntarily reporting adverse events and near misses to a confidential web-based data base.
Developed with the input and testing of front-line hospital personnel, the data base captures both statistics and the story behind the adverse events. Protected by peer review laws that allow for sharing of this type of information among hospitals, the voluntary reporting system promises to be a valued tool in improving patient safety.
Additional functionality is being included in the real-time analysis of information as it is submitted to prompt the user to additional reporting requirements such as JCAHO or the Minnesota Department of Health. Through the on-line push technology, instant alerts can be sent to warn users of newly identified patient risks.
As the advisory committee deliberates adverse event reporting, MHHP urges the committee to adopt a voluntary approach to reporting that recognizes state-specific initiatives already in place. Minnesota is making great efforts to change the health care culture for patient safety. In state-wide cooperation through the Minnesota Alliance for Patient Safety, a coalition of over fifty organizations here in Minnesota, has raised the awareness of opportunities for change; and several efforts towards improvement are well underway. Developing a positive culture is absolutely key to improvements, and clearly a reporting system that is voluntary helps set the tone.
Three other observations that the association would like to make have to do with general regulations. Regulations and their implementation tools should remain consistent with the intent of Congress. Too often relief given by Congress is canceled by the bureaucratic and red tape required to obtain the relief.
Three specific examples are from our most vulnerable hospitals. The designation of critical access hospital-- and, by the way, there are 44 of them here in Minnesota-- was to preserve access to critical care in rural areas. We've had trouble implementing that through surveys and also a cost report change. For disproportionate share hospitals, we have trouble getting their payments from the Medicare intermediary.
Second, rules should not be retroactive, nor should they be promulgated without appropriate notice. And I think the Medicaid upper payment limit is a good example of that.
And, lastly, intermediary performance is very important. And the evaluation should demand timely audience and payment timeliness, and the intermediaries should be held to those standards. Thank you.
DR. WOOD: Thank you very much. Next I would like to invite Mr.Dan Peterson. Mr.Peterson, Dan Peterson?
MR. PETERSON: I'm going to pass out a hand-out that relates to an item in my presentation or testimony. Mr.Chair, members of the committee and distinguished guests, I would like to thank you for the opportunity to present. My name is Dan Peterson. I'm the senior director for community services at North Memorial Hospital. And I'm also the immediate past chair of the Minnesota Home Care Association, which is the voice of home care in Minnesota.
I would like to speak about three things today. No. 1, OASIS and the definition of skilled versus non-skilled. No. 2, the use of frequency and duration when writing orders for patient services. And, No. 3, the application of the conditions of participation.
First of all, OASIS and the definition of skilled. I do not believe there is anything more confusing in regards to operationalization of OASIS than there is the skilled versus non-skilled definition. Medicare defines skilled as a service which must be provided by a registered nurse or supervised by a registered nurse in that we need to consider both the inherent complexity of the service, the condition of the patient and accepted standards of medical and nursing practice.
The Nurse Practice Act in Minnesota defines activities such as assessing and teaching activities that require the skills of a registered nurse. Our state survey department has chosen to adopt the position that a patient is receiving skilled care on the sole basis of the language, teaching and assessment of clinical record. This is a total disregard of a patient's overall condition and defies the current Medicare definition. The solution to this would be to apply OASIS only to Medicare patients.
The second area, use of frequency and duration on home care orders. Medicare requires that we state the service and the frequency with which we will be providing the service. The hand-out that I have given you is how we are required to record our services. As you can see, this is a little bit confusing or can be.
Under the old system of payment when visits were paid or reimbursement was by the visit, this was an appropriate methodology in order to allow the physician to act as the gatekeeper and assure that costs were in line.
However, under the new payment system, it really makes no sense; and it actually serves to have a significant layer of paper shuffling. Every time a visit is missed, an order must be written in order to justify the missing of that visit. This process consumes valuable time on the part of the agency, nursing staff, clerical staff, quality assurance staff, as well as the clinical clerical staff, clinical nurses and the physician with no significant positive impact on the quality of care. The solution would be to allow agencies the flexibility to state in the physician's order how many visits of each discipline will be performed in a 60-day episode.
Finally, the application of the conditions of participation. Under the current system, the Medicare COP's apply to all patients admitted to a Medicare-certified agency. The only way to get around that is to develop a second agency. For larger agencies, this may not be as much of a factor due to economies of scale when it comes to separate governing and administering systems.
However, for smaller agencies such as mine, the two choices are incur additional expense to set up a separate agency or incur additional expense to continue as a single agency, not a very good set of choices. The solution would be to apply the conditions of our participation only to Medicare patients. And by doing so, both OASIS and the COP problems identified here would be resolved.
In summary, on average it takes our nurses about one and a half hours to complete all activities related to a home care visit. Of this time, only about 20 to 25 minutes is spent with the patient. 72 percent of the nurse's time is consumed with non-patient-related activities, 69 percent of which is paperwork. This is a significant job to satisfy which must be remedied in view of the current nurse staffing crisis. Again thank you for your time. I hope you enjoy your stay in Minnesota and good luck on your mission.
DR. WOOD: Thank you. Next Mr.William Preston.
DR. PRESTON: Very good. Three in a row. I'm Dr.William Preston. I'm representing the Illinois Academy of Family Physicians. And I'm grateful for the effort to find some uniformity and some regulation in Medicare rules and regs. I was very grateful for Dr.Laconis's comments the last meeting in Denver requesting standardization in billing and uniformity in regulations.
If it was just Medicare that we had to deal with, it would be very easy. But all of the pharmaceutical benefit intermediaries and insurance companies have their own rules and regulations, and I should tell you as a practicing physician a third of our time is spent trying to meet everybody else's rules. And that takes a away from patient care.
A lot of things have been done in terms of medical regulations. One that I would like to point out is the CLIA, Clinical Laboratory Improvement Act. It's hard to argue against laboratory improvement, but some of the rules and regulations have made it impossible and impractical to do physician office testing. And that has led in many instances to decreased efficiency and decreased timeliness in delivering patient care. So we have a two-edged sword. We have tried to improve things; but in improving them, we've also negatively impacted our ability to provide care for our patients.
Dr.Jane Orient pointed out at the last meeting that a lot of these rules do not work. She's right. I had the opportunity yesterday to give a sermon on faith versus following the laws in terms of sanctification and justification. The point was clear. Laws don't work. Faith does. In the 1970's, there was a popular saying, "Keep the faith, baby." Practicing physicians are doing that. Regulations interfere with that. So with regulations I would like to ask that you do the same thing we do with beta-blockers for congestive heart failures; start low and go slow.
DR. WOOD: Thank you, Dr.Preston. Next, Debra Klatkiewicz.
MS. KLATKIEWICZ: Good morning and thank you for the opportunity to speak. My name is Deb Klatkiewicz, and I'm the administrator of personnel and regulations at Park Manor Nursing Home in Park Falls, Wisconsin. I also serve on the Wisconsin Health Care Association on the board of directors. And on behalf of both organizations, I thank you for your efforts.
I have read the comments of other long-term care providers, including the American Health Care Association to this committee, and I support those unilaterally. I'm here to put a face on those comments that you've already received in the nation-wide abuse of power demonstrated by the performance of surveyors in interpreting and enforcing the requirements for long-term care.
Park Manor is a private Medicaid/Medicare-certified skilled nursing and rehab facility licensed for 166 beds in Park Falls, Wisconsin, a small rural community in northern Wisconsin, even farther north than Minneapolis.
The facility has been very stable both in terms of administration and staff. The senior and active administrators have all been employed for 22-plus years. The most recently employed department head has been there for sixteen. Employee service across all departments averages less than ten years. The facility has had the same ownership since the seventies.
We surveyed out of the Rhinelander regional office of the Bureau of Quality Assurance in Wisconsin. In May of 2000, we had our annual meeting survey, and it took about 151 hours. We wound up with 13 deficiencies, which we reduced to 4 following IDR.
The next annual survey at Park Manor was March 14th through March 22 of 2001, ten months from the 2000 survey. This time we had federal surveyors through the FOS system and our state surveyors, and it took 465 hours. At exit interview we were told we had 37 deficiencies. On the SOD or statement of deficiencies, it was reduced to 29. We also had 5 other deficiencies removed following informal dispute resolution, including an immediate jeopardy finding.
All deficiencies were appealed through the federal process and the State 5 ClassB deficiencies, which mean we were harming residents, were also appealed. We chose to go public with this information both to our local media, to our state legislators, to the governor's office, local officials, state and national associations and most importantly to our residents, family members and staff.
The press coverage and our efforts have elicited response from all of our community in the state. Our legislators are championing the cause of over-regulated and over-scrutinized nursing facilities. Currently a formal audit of the regulatory process of the DHFS regarding nursing homes is being conducted by the State of Wisconsin. It has become apparent that while we feel we have nothing to hide, the more we have revealed, the more positive the response has been.
Unfortunately, there have been some negative responses involving the experiences of our staff, residents and family members during the survey. The tension of having so many surveyors in the facility for so long was incredible. However, what was most disheartening was the reports of poor treatment family members experienced. Indeed, two of the family members had the courage to testify at our state hearings not only to their poor treatment, but to the good treatment provided by the facility.
In one case, the wife of a family member testified that during a surveyor interview the test of their, quote, the surveyor looked at me and she said that possibly I wasn't the proper person to be making decisions for Franklin. And she looked at me, and she pointed her finger at me and she said, "Do you fully understand that the decision you are making is you are choosing to kill your husband?" Not only had this family member been the primary care giver for this resident for many years, but she was also an emergency medical technician.
Following our state hearings that started in August and concluded in October of last year, a total of 13 days, the State of Wisconsin reversed all 5 of the state deficiencies. The administrative law judge concluded, quote, the citations primarily boiled down to a second guessing of the balancing decisions made by treating facilities, facility staff and family members of the residents. One can argue with the facility's decision in individual cases, but the department has failed to prove by a preponderance of evidence that any of the decisions for which the facility was cited violate the available provisions.
I see that my time has run out. I just ask that you read my written comments and that you look at the way these regulations are being enforced. Thank you.
DR. WOOD: Thank you very much. Mr.Steve Brennan.
MR. BRENNAN: Hi. My name is Steve Brennan. I'm with the Providence Health System based in Seattle, Washington. We're a non-profit hospital system in Alaska, Washington, Oregon and California. And my comments are more specifically related to this afternoon's session on improving FDA and CMS collaboration.
We agree with the need for careful and thoughtful process in determining safety and approval for FDA, for drugs and devices. We thought that there are some areas that the two agencies could work together more closely. One recommendation that we have is to bring together the two agencies in a more formal fashion through what we've sort of termed loosely a joint office of break-through technologies that might bring the two agencies together more formally earlier on in the process to share information that is needed by FDA and CMS to make a determination not only for FDA approval, but also for coverage and then later reimbursement so that in a way the relay race, the baton is handed off more smoothly and earlier in the process.
Secondly, we would recommend that CMS should consider expanding Medicare coverage policy for clinical trials to include trials that are not government sponsored necessarily, but otherwise meet criteria specified in the Medicare coverage policy for clinical trials.
Thirdly, we would like to see FDA and CMS undertake initiatives to better educate physicians so that they understand what's covered by Medicare and what's not. We have quite often situations where a physician, particularly in the outpatient setting, will not be clear on what drugs or devices are approved by Medicare for coverage, and it creates some confusion and difficulty.
And then finally-- and I'll keep my comments brief, we would like CMS to consider excluding selected new technologies from the PPS for long-term care, skilled nursing and home health agencies. Currently the PPS systems for the two service lines do not accurately account for the cost of new technologies, and we believe those new technologies should be excluded and paid on a cost basis until such time as the PPS can be adapted through rule making. And those are my comments. Thank you.
DR. WOOD: Thank you. Next Mr.Rick Kingston.
DR. KINGSTON: Good morning. My name is Rick Kingston. I'm a pharmacy doctor and associate professor in the department of experimental and clinical pharmacology at the University of Minnesota. I'm also a senior clinical toxicologist and vice-president of the Prosar International Poison Center.
Our center really focuses on post-market surveillance and medical support for large entities. We handle in excess of a hundred thousand medical-related inquiries and incidents involving a variety of product-related types of issues.
And I'm here today really to speak on behalf of both the University of Minnesota, also the Minnesota Pharmacists Association where I sit on the patient safety task force and head up the section on data collection. And we're somewhat concerned about the new phone number idea, and this idea of having a phone number going into an old system with an old mind set.
And really to expand on that a little bit, we're critical of a single national phone number which goes into a regulatory agency with the idea of one size fits all, with really a focus on just collecting information. It's essentially that idea that was brought up by other folks today about a one-way street. One of the biggest problems that we've seen with the existing system, including MedWatch, is that you don't get back advice or recommendations immediately when you have an incident at hand.
Secondly, just to give the committee some suggestions and certainly the FDA is to take a closer look at the FIFRA 6A2 ru