Hearing of the Senate Committee on the Judiciary - Electronic Prescribing of Controlled Substances

Hearing of the Senate Committee on the Judiciary - Electronic Prescribing of Controlled Substances

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SEN. TOM COBURN (R-OK): It's curious to me that with all the benefits that we're going to get from e-prescriptions why you all would not say here's the things we have to have as you do this. In other words, rather than worry about the "what ifs," why don't you tell us what the "what ifs" are and have us write legislation that covers it?

There is no question the consumers are going to be better off in this country with the pharmacists not reading my handwriting. There's no question about that.

And there is no question -- there is no question -- that control of controlled substances is going to be far improved with e- prescriptions. Will there be new potentials for abuse? Yes. Will there be new loopholes?

But I think that, reading the history on this last night, it seems to me that the problem is that DEA needs to tell us, "Here's the things we're concerned about; fix that as you write this and you change this," rather than saying we can't get there. We have to get there.

We have a lot of problems in terms of IT interoperability now in health care and that's something the administration is doing a great job on. They don't need a piece of legislation for it. They're actually accomplishing it under Secretary Leavitt now.

But assuming that the interoperable standards are going to be there and that the medical community and the health care community is going to eventually go online with medical records, et cetera, to say that we can't come up and lead on what is necessary -- and I just liked your comment -- why wouldn't you just give back to this committee "here's the things that we think have to be included in anything that has to happen in terms of e-prescriptions for controlled substances"? And then let us work with you as we formulate legislation to create that so that we have the safeguards against abuse of controlled substances?

MR. RANNAZZISI: Well, Senator, I believe we've gone on record numerous times as saying the three things that we need are authentication, non-repudiation and a system that protects the integrity of the record-keeping process. The devil's in the details.

And I would love to sit here and give you a laundry list of things that we need. Technically, I'm not the person to do that. That's what I have a technical staff for. However, they're just as cautious of developing these protocols as I am because they know that we have pretty much one shot to do it right. If we don't do it right, there could be a massive problem in the system which causes a lot of diversion, a huge avenue of diversion.

That's what a pilot program is for. That's why this pilot is important to us. And in fact, the Massachusetts pilot was just resubmitted last Thursday, and we're in the process of reviewing it now. If we get that pilot up and running, we'll have a better idea of how the system works.

SEN. COBURN: There's a massive amount of diversion now.

MR. RANNAZZISI: Yes, there is. And we don't want to contribute to that.

SEN. COBURN: But not looking at the opportunity for eliminating what's there now by going to an e-prescription would seem to me -- you have a shop. You can offer us suggested legislation that would raise your concerns on that that would address every concern that the DEA would have.

MR. RANNAZZISI: Leaving the rule-making process right now and drafting proposed regulations -- I think we're requesting more time to get this right.

I would love to give you language for legislation but we're so far along on the rule-making process right now, the reg process right now, and I think if you just give us a little more time we'll have something that we'll all benefit from.

SEN. COBURN: What is a little more time?

MR. RANNAZZISI: (Laughs.) That's the question of the decade.

If the Drug Enforcement Administration was the approving authority, the sole approving authority for all rules and regulations, as the head of the Office of Diversion Control, I would give you a time. But it's not. We have to go through a process of vetting with several agencies and several different components of the administration.

If I sat here and gave you a time limit, I'd be lying to you, and I don't want to do that.

SEN. COBURN: Good. Give us the time at which you will offer that vetting to the other agencies.

MR. RANNAZZISI: At this point in time, I don't believe I'm able to do that.

SEN. COBURN: Well, is there a time at which you will be able to give us that?

MR. RANNAZZISI: Yes. Yeah, I'd like to see -- once Massachusetts is up and running, I'd like to see how their program's working.

SEN. COBURN: You know, that's a little bit frustrating, just to be quite honest with you. The fact is is you're responsible for control --

MR. RANNAZZISI: Yes, I am.

SEN. COBURN: -- of controlled substances in this country. And there is no question -- it's an indisputable fact -- that we're going to have a better handle on it if we do it in a more advanced technological way. E-prescriptions is that way.

And the idea is that you don't want to go on record to be held to account because somebody might hold you to account is why we're not going to get there as soon as we should get there. And every day we don't get there, somebody dies from an overdose. Somebody puts somebody onto a drug. We see more drugs on the street. And the fact is we're talking about ways to actually improve the DEA capability to enforce and do its job.

You know, I will submit some letters -- some questions in writing, but I don't think that's an acceptable answer --

MR. : I agree.

SEN. COBURN: -- of not getting us to the point. There ought to be a time at which you can, with your staff, say we will have a position of DEA on e-prescribing that raises the areas that we think are a problem, at which time we will submit it for vetting for the rest of the administration.

We'll do the oversight. I think Senator Whitehouse has proven that he's capable of doing the oversight.

If you've submitted it and we know it, then we'll be bringing everybody up here and say what's wrong with it?

The fact is that we need to get there. We're behind the rest of the world in terms of IT and health care, and this is a large component that's going to make a big difference in terms of offering health to people and safety to people. And so I just think that we need to have a date from you at which you say -- you all know the process, and I'm very supportive of the DEA. I know a lot of the problems with controlled substances is physician-based because we don't do our job, or we don't do it the way we should.

But this is an area of expertise and technical nature that you all have and can have and can offer, and we ought to have a time frame. My fear is we're going to be sitting here two years from now doing the same things because the pilot didn't go as you wanted. Well, so what if the pilot doesn't go? If you know what you want and you know what you need, we can solve the problems. But we can't if we don't start, and the starting point has to be with you all saying here's what you'd like to have.

MR. RANNAZZISI: Well, sir, we look forward to working with this committee and working with your staff and Senator Whitehouse's staff. And we'd be more than happy to provide briefings for you on where we are and how we're going about the process.

I regret that I can't give you a date, a hard date. I would love to give you a hard date. I'm a health professional. I'm a pharmacist -- a registered pharmacist -- by trade, so I understand the problems. Okay? But I just think it would be foolish for me to give you even an estimate because I'd just be speculating.

SEN. COBURN: So there's nothing inside your organization today that says we have a goal to get there X?

MR. RANNAZZISI: Yes, there is.

SEN. COBURN: And when is that? When is that?

MR. RANNAZZISI: We have a goal to get to a particular place. Okay? But we don't have a time period yet.

I could tell you we are drafting regs. We've been in contact with HHS. We've discussed our regs with the department. We've discussed our regs with ONDCP. It's in the process. However, I just can't give you a hard date. And again, that would be reckless for me to give you a hard date. When? Trust me, as soon as possible, as far as I'm concerned.

SEN. COBURN: Okay. Thank you.

I don't have any other questions.

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SEN. COBURN: Mr. Chairman, can I?

SEN. WHITEHOUSE: Please.

SEN. COBURN: Two years from now will we have a system?

MR. RANNAZZISI: I would hope so.

SEN. COBURN: But you can't say yeah, we will?

You know, we're getting to that Coburn's theory of bureaucracy: Never do what's best when you can do what's safe.

Now, I understand you're a safety agency, but the goal is is hiding behind a message that allows you not to step up to the line. And that's what I'm hearing and that's what I don't like. And it has nothing to do with you personally, Mr. Administrator; it has to do with the fact is is everybody else that's sitting here watching this hearing is saying, why couldn't they do it in two years? You know, why couldn't it get done in two years? The question is is obviously it could if people committed to it and did it, but what we have is no commitment, which is worrisome because we may be here two years from now with the exact same problem on controlled substances. And my dealings with the DEA in the past have been very, very similar in terms of responsiveness.

So you need at least to give the committee some type of assurance we're going to get this problem solved and some time frame in which we're going to. If you say three years, great, three years. But to not say anything means that you're not going to go out -- you're not going to step up to the line and say here's something we need to do for this country.

MR. RANNAZZISI: Sir, I would hope that within three years we have a system in place and that -- my personal goal is quite a bit shorter than that, but in three years I would hope to have some system in place, yes. And, you know, obviously it's a personal goal to have it a lot quicker, but, you know, if you're asking me for three years, I believe that in three years some system will be in place, yes.

SEN. COBURN: Have you communicated with your staff that this is something we're going to get done and we're going to get it done in a certain time frame?

MR. RANNAZZISI: My staff is right behind --

SEN. COBURN: No, no. I said have you committed -- communicated to your staff that this is our goal, this is what we're going to get done and we're going to get it done a certain time frame?

MR. RANNAZZISI: I've communicated to my staff that we have a goal and we want to get to it as quickly as possible -- however, with the appropriate safeguards to protect the integrity of the closed system. Yes.

SEN. COBURN: But every agency head in this federal government can answer a question that way. What I'm saying is have you set a goal, a time goal, within your staff to get something done?

MR. RANNAZZISI: No, I can't -- I can't set a time goal, sir. I mean --

SEN. COBURN: Okay.

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