any observation of diversion in your experience or in your surveys in this source?

Mr. HIGLEY. Senator, it is very limited at the present time. I have given testimony in my statement that I think the possibility is there. Therefore, the bill is a good one.

Senator HRUSKA. We recognize that without any hard evidence. We have to treat it very respectfully, but at the same time there is the possibility. There is the potential. That is one of the fields into which the bill introduced yesterday goes into, isn't it?

Mr. HIGLEY. Yes.

Senator HRUSKA. There will be a power discipline and there can be revocation of registration and a cutoff of any future supplies? Mr. HIGLEY. Yes, sir.

I would also testify that we have a limited capacity with the staff we have to ascertain this.

Senator HRUSKA. Do you have any statistics on thefts of methadone either by wholesalers or retail plants or doctors' offices or from the programs themselves?

Mr. HIGLEY. I did not come prepared with any statistics, but I would testify that to my knowledge one of the best sources is to ask the law enforcement people what kind of bleed-back they might see on the streets. From the three programs that exist in Nebraska, I would say it is almost nonexistent at this time.

Senator HRUSKA. We find in other parts of the country, I am told by staff, that the retailers are one of the soft spots in that regard.

Mr. HIGLEY .We have loss of methadone from the retail pharmacies, along with all other controlled substances in break-ins and thefts and armed robberies, and these kinds of things. They take all the high-level schedule II analgesics.

Senator HRUSKA. I am very well impressed by your testimony in regard to the memorandum of understanding between the Federal authorities and the various agencies within the State. So often we meet with the criticism, whether it is founded or not-sometimes it is and sometimes it isn't-that there are so many agencies and offices interested in one aspect or another of this program that one doesn't know what the other one is doing, and there is duplication and sometimes interference. One purpose of that memorandum of understanding is to get at that problem, is it not?

Mr. HIGLEY. Yes, sir.

Senator HRUSKA. Do you find that it is working satisfactorily so far?

Mr. HIGLEY. Yes, sir. I am behind it, but I think the division of drug control, the State patrol, and with special emphasis on the vice squad of the Omaha police department, and our agency, each functioning in their own area, has been very satisfactory and very cooperative. The memorandum of understanding between the Bureau of Narcotics and Dagnerous Drugs and our office has been tremendously successful, and the registration programs between our regional office in Kansas City and our office has been unprecedented. I am very impressed with it.

Senator HRUSKA. In your testimony at page 4, you outline in some detail your board's approach to the control and survey of the use of controlled substances. Having those five subdivisions or classes in

mind, what would you say as to the cooperation among the several agencies that you must work with in discharging those duties?

Mr. HIGLEY. Senator, if I understand your question correctly, when you say agencies that we work with, you are thinking of the Bureau of Narcotics and Dangerous Drugs, Federal and local agencies?

Senator HRUSKA. The works. For example, you conducted investigations that have been referred to you by cooperation with law enforcement agencies, the State patrol, sheriffs' offices, vice squads, and other peace officers. There are others, but that is one example.

Mr. HIGLEY. Yes.

Senator HRUSKA. My question is, what degree of cooperation is there? Is it satisfactory? Can it be improved upon?

Mr. HIGLEY. I think cooperation can always be improved upon, Basically, I think probably our cooperation with them could be improved, but I think you will find that it is outstanding so far as our judgment is concerned in these areas, Senator. I think we have good relationships.

Senator HRUSKA. What responsibility does your department have to assure that the criteria for program selection is presented? Have you any supervisory powers?

Mr. HIGLEY. We are just now, as Mr. Kushner testified, being named by the Governor to work in the methadone treatment program as a regulatory function under the FDA regulations. That has been assigned to our department, and it is our intention to work jointly with these people in the development of standard rules and regulations in this area. If there is a weakness, I would suspect that this is the weakness area at this juncture.

Senator HRUSKA. What about the supervision and the assurance that would be expected of you in regard to the take-home privileges, and that the rules and regulations are followed in that respect?

Mr. HIGLEY. I think we have some responsibility here. We haven't exercised it completely in this area, Senator. I am sure that my testimony would be that we would have to control this more than we have in the past so far as rules and regulations to assure that this would not occur, but I am still testifying that I don't think that we have a problem, but a potential for it.

Senator HRUSKA. What about storage and safekeeping of inventory? That is involved also.

Mr. HIGLEY. Yes, sir, that is also involved, and we have also done a better job in that area.

Senator HRUSKA. You have several times mentioned the bleedback of methadone into the drug traffic of the Omaha area and other localities in the State. What other substances are available on the streets of Omaha, or other Nebraska cities, besides methadone?

Mr. HIGLEY. I don't think methadone is really available too much, but of course the things that are available now are heroin, and the amphetamines, the barbiturates.

Senator HRUSKA. What about methaquilon? Is there any of that? Mr. HIGLEY. I do not know, but to my knowledge, no.

Senator HRUSKA. In some cities we have come across its appearance. I just wanted to find out whether you have had any experience with it here.

Mr. HIGLEY. No, I couldn't say. I imagine Chief Andersen could answer that better, but I don't think so.

Senator HRUSKA. We will get into this question later, also perhaps with the physicians but you have stated quite unqualifiedly that oral administration at the methadone center is almost mandatory.

That, of course, is criticized by some people, including Dr. Cushman, for example, whose report we will explore with some of the other witnesses. Dr. Cushman says that it is counterproductive because it leads to the reluctance of the addicts to come to the center on a daily basis. Rather than pay that price in terms of time, expense, inconvenience, and the necessity to do it, they would rather stay on the black market, as it were.

Do you have any comments in that respect?

Mr. HIGLEY. I think that this is an item that is real hard. There is certainly something to be said on both sides of this question, and I would admit, Senator, that this is very little, but the position I am making is based upon the experience, limited as it may be, and my personal bias in the experience in Nebraska, and with special reference to Omaha, where prescriptions were the method in which methadone was prescribed to the addict as the modality of treatment, written and being circulated to the pharmacies of the city to be filled.

One, this creates the opportunity, because the addict at that juncture in time, and I choose to use the words "drug dependent", is not really stable, and he may or may not utilize it properly.

The other thing is that once it leaves the center, it just seems to ne that the availability and the potential for it getting into street evel is increasing.

That is why I made that statement. It is admitted that it makes it lifficult for this individual to come back to the center for oral dose. Every modality is made so that it gums up and can't be shot and inected. Those utilizing the oral medication believe, as I do, that here is a problem with it when it is administered in any other way. Senator HRUSKA. There are prices paid either way, aren't there? Mr. HIGLEY. Yes.

Senator HRUSKA. One must balance the good and the bad of each ethod and then come up with his estimate judgment of what to do. Mr. HIGLEY. This is true, but as I said, here is a regulatory agent with my bias.

Senator HRUSKA. I want to say that from your description of the tivities of your board and related matters, there is much to be conidered heartening. Contrary to much public belief, much is being one in this field in a very constructive and thorough way. I think our board is one example of it, and the Drug Commission, as well. Thank you for coming and giving your testimony. [Mr. Higley's prepared statement is as follows:]

PREPARED STATEMENT OF REX C. HIGLEY, DIRECTOR, BUREAU OF EXAMINING BOARDS, DEPARTMENT OF HEALTH, STATE OF NEBRASKA

Mr. Chairman, and members of the Senate subcommittee; thank you for iving me this opportunity to appear before you today and give testimony zarding the utilization of methadone as a modality of treatment for heroin diction.

91-486-73-25

The Bureau of Examining Boards of the Department of Health, State of Nebraska, is the agency of state government responsible for the enforcement of that section of the Nebraska criminal code which provides the controls for possession, distribution, prescribing, and administration of controlled substances in the legal channels of distribution. Primary duties for the enforcement of this same section of the criminal code of Nebraska in the illegal channels of distribution, rests with the Drug Control Division of the Nebraska State Patrol and all peace officers of this state. The Bureau of Examining Boards also has the responsibility for the licensure and the enforcement of the prac tice acts of seventeen health-oriented professions and occupational fields.

Approximately in April 1970, this Bureau, through the signing by the Governor of Nebraska; entered into an agreement with the United States Department of Justice, Bureau of Narcotics and Dangerous Drugs, which assigned certain responsibilities for the enforcement to this state agency. This agreement was a "Memorandum of Understanding" between the Federal Agency and the State Agency. Such a "Memorandum of Understanding" did not confer upon the state agency any real authority for the enforcement of federal statute, but it did avoid duplicity of enforcement procedures and investigations under certain conditions; and this memorandum did assign certain responsibilities to the Bureau of Examining Boards which required single investigations conducted by the Bureau but reporting to both federal and state agencies. Additionally, cooperative "on-site" inspections and investigations were provided for in this agreement. The state agency was also assigned drug accountability audits; purchase reviews, etc.

This extremely brief review of the authority of the Bureau of Examining Boards is essential to the understanding of the testimony which I wish to give before this subcommittee today.

A great controversy has arisen regarding the use of methadone as a modality of treatment for heroin addiction. This committee has already heard a great amount of testimony, here and elsewhere, regarding this controversy. Therefore, as an administrator for a regulatory agency, I could best serve this committee by giving only factual testimony pertaining to the utilization of methadone in Nebraska. I suppose this shall not be the case and my bias and opinions will be a part of this testimony. Never-the-less, I shall attempt to establish for the committee the background facts and current status of the regulation of existing programs existent in the State of Nebraska; and to reveal through this testimony, levels and quantities of the use and distribution of methadone in the State of Nebraska at the present time.

Nebraska does not have a pharmaceutical manufacturer of methadone. Dorsey Laboratories; this state's largest pharmaceutical manufacturer, does not utilize methadone in any of their manufacturing processes, to my knowledge.

In preparation for this testimony and as a result of previous inspections, I have determined that the three major wholesalers' distribution levels of methadone is minimal at the present time. This is especially true when you compare the amounts of methadone distributed as compared to another medical analge sic such as Demerol (Merperidine), as an example.

Observation of the distribution levels, prescribed and dispensed quantities of methadone in legal channels of distribution reveal that methadone (Dolophine, and/or Amidone), classified as to utilization as an analgesic in comparison to other drug substances would be down the list in fourth or fifth place in the State of Nebraska. The primary, current use of methadone is to ameliorate the withdrawal symptoms associated with heroin and morphine addiction. F.D.Ag as recently as December 15, 1972, proposed regulations which would remove methadone, for the most part, from the legal channels for analgesic use and rescinded it's use as an antitussive agent.

Regulatory agencies use several methods to determine the levels of use and prescribed amounts of any given controlled substance. (Narcotic or dangerous drug). Some states have the triplicate prescription form method which permits these agencies to constantly survey the utilization, (legal channel), of all con trolled substances. This procedure with all that is involved pertaining to data processing and computer utilization is extremely costly and time consuming at all levels (prescribing; dispensing, and regulatory). The Bureau of Examining Boards' approach to control and survey the use of Controlled Substances has been: a) routine inspections of all levels of distribution

b) review of purchases of all legitimate users. (By review of orderform purchases)

c) survey and inspection of all treatment centers, in cooperation with B.N.D.D. agents through on-site inspections. (Jurisdictional considerations have precluded our inspecting federal centers.)

d) Conducting investigations which have been referred to the agency by cooperating law enforcement agencies. (State Patrol, Police Vice Squads, Sheriff's offices, and all other peace officers.)

e) Investigations of all apparent or alleged possibilities of diversion, by audit and recommendation for appropriate actions taken against professionals who have engaged in any activity, even poor record keeping. Having followed such procedures as outlined, the Bureau of Examining Boards has determined the following to be resultant conclusions regarding the controlled substance methadone.

1. The primary use of methadone in Nebraska currently, is as a modality of treatment for heroin addiction.

2. The amounts being prescribed to be used as an analgesic are low by comparison to other analgesics and it's use as an antitussive is rapidly becoming non-existant due to the F.D.A. proposed regulations.

3. Even though it would appear that methadone would be safe and effective under certain conditions, when used in especially well-managed programs, as one means of treating a certain percentage of heroin addicts, Senator Cook's Bill, S.B. 3846 amending certain portions of the Controlled Substances Act of 1970, is necessary legislation. Primarily the inclusion of registration of all treatment programs and practitioners which engage in the treatment of addiction through the use of methadone is needed.

The discussion of the utilization of methadone as a detoxifying agent or the use of methadone as a maintenance substance, in the treatment of the heroin addict has reached a status of controversy, even in the news media of today. One local authority has been quoted saying, "To substitute one chemically addicting substance for another is morally wrong." Another, has been quoted as stating, "This is an over-simplification and methadone certainly provides an opportunity for the individual who can not live a drug-free life at a certain time in his life and it allows the addict to do things that they could not do if they were still using heroin; such as finding a job, socializing,and staying out of trouble with the authorities of law enforcement." Still other individuals contend that the addiction levels (physiological dependancy), of the "street heroin" (Omaha World Herald) are not sufficient to precipitate removal symptoms to the degree that methadone would be required. "It is like a mild case of the flu," they say.

One local authority contends methadone is needed for persons addicted less than two years, especially when used as a detoxifying agent, but opposes methadone maintenance. The quoted news statement here was that, "In methadone maintenance, the patient is kept deliberately addicted to methadone with no short-term intention of attempting to detoxify the addict. (Using the term detoxify here to mean: take the patient to a drug-free state.)

The Bureau of Examining Boards' activities in the methadone programs in Nebraska, developed as a result of two factors:

1. The requirement, under L.B. #326, that all persons legally possessing or distributing Controlled Substance must register with this bureau.

2. Certain responsibilities jointly understood as both Federal and State responsibilities under the "Memorandum of Understanding" with B.N.D.D.

According to the records of the Bureau of Examining Boards there are three Methadone Maintenance Programs currently functioning in Nebraska. One program is under the supervision of the Nebraska Phychiatric Institute, University of Nebraska Medical Center, Omaha, Nebraska. The director of this program is Dr. Irvine Blose. Patients in this program are handled exclusively on an in-patient basis. In most all cases, our reports show that these patients are institutionalized for treatment. The capacity of the program is apparently limited to a small number of patients; possibly a maximum of ten to fifteen addicts at any one time. Our records show that the program is closely supervised and professionally administered.

Another program is the Drug Unit of the Veterans' Hospital, in Omaha, Nebraska. As a state agency, we have no real jurisdiction over this facility and