One program is under the supervision of the Nebraska Psychiatric Institute under the direction of Dr. Irvin Blose. Another program is the drug unit of the Veterans Hospital in Omaha, Nebr. As a State agency, we have no real jurisdiction over this facility and have not inspected the unit's program. We are aware of the program, however, and can report that it is primarily an inpatient program, with a very limited and gradual opportunity on a pass basis for the addict to be treated as an outpatient. This is primarily an in-patient program at the University of Nebraska Psychiatric Institute. Primary advantages for inpatient treatment are: Yo remove the addict from the drug-oriented environment; an attempt to prevent the addict from being physically able to get "street drugs." Of course, this does then limit, on the other side of the coin, the opportunity to have contact with the addict in the field. Again, I estimate that the believed number of treatments of addicts in these areas is low, and the estimates frequently made regarding the capacity of this institution for treatment is low. An extremely different type of methadone maintenance program functions at 4924 Poppleton, Omaha, Nebr. This is a "street clinic," in a sense, commonly known as "Equilibria." This program was initially instituted by Donald Parkinson, M.D., now no longer with the clinic. The original program was a detoxification center, as we measured it. The initial onsite inspection was conducted of this facility by the then agent of the Bureau of Narcotics and Dangerous Drugs, Mr. Laverne Gooder, and myself, the director of the bureau of examining boards. During this inspection, these agencies had several concerns and instituted a request for mandatory compliance which was quickly complied with in every detail by this center. Patients at the clinic were then, and still are, primarily treated on an outpatient basis. Originally, as it operated as a detox-center, prescriptions for methadone were written by the physicians on duty. These prescriptions were then taken by the patients to the various pharmacies throughout the city of Omaha for filling. Rumors and arrest statements by persons arrested for possession and sale, as reported back to the regulatory agencies, both BNDD and our office. suggested that as a result of this prescribing procedure, methadone was becoming a street drug to at least some degree. Additionally. pharmacists were on occasion being harassed, especially if the methadone stock in their inventory was insufficient to fill the prescription. The pharmacists have been instructed by our office to maintain low inventories of all schedule II substances, and to reorder frequently both by Federal and State agencies, the reason being the ever increasing amount of theft and burglary. More than once altercations between addicts and pharmacists occurred. One pharmacy owner alleged, and we have no proof of this, that he may have suffered a loss of his pharmacy by fire as a result of such an altercation. Nevertheless, during this time, the majority of these methadone prescriptions were being filled at one hospital pharmacy. This pharmacy was staffed on a 24-hour basis with only one pharmacist at the night areas. Many of the prescriptions were written for clinic patients in the late evening, and therefore they were brought to the pharmacy in the late evening hours or early morning hours according to the pharmacist in charge of this pharmacy. Patients appeared frequently about midnight in multiples with singular vehicular transportation. With one pharmacist on duty this presented a problem to him, and finally, a security guard was hired to secure compliance with the hospital policy that only one individual could go to the pharmacy at a time. Because of the great potential for, and at least our belief that it could be occurring, that is, methadone reaching the streets, and because of the difficulties which seemed to occur frequently in the pharmacies under this prescribing by the prescription system, we urged Dr. Parkinson to hurriedly make application for and establish the necessary IND's and become a methadone maintenance program were methadone could be orally administered at the clinic. In addition, our investigation revealed by monitoring the prescriptions that were being written, in certain instances the limit allowed for a detox center for treatment was being exceeded. Compliance was requested and the center complied completely and quickly. Undoubtedly, however, this was contributory to the center initiating a request for a methadone maintenance program. During the initial on-site inspection, both agencies had a concern about the procedure followed at Equilibria to assure the anonymity for the patient-addict. We were informed that the addicts would not come into the center if this was not insured. With the realization that this was a rehabilitation center of a new type to us and the first of its kind in Nebraska on primarily an outpatient basis, we did not press the issue in this regard. All other recordkeeping seemed to be in compliance with Federal and State requirements at that time and on subsequent visits to the center. As a matter of general interest, patients at Equilibria are provided laboratory evaluation. urinalysis, and some blood chemistry. There is a certain amount of counselling, and this is not for us to talk about at this time. At the approximate time that Equilibria was approved and began to function as a maintenance clinic, Mr. Laverne Gooder and I revisited the center for a renewal inspection. During this inspection, realizing the methods for prescribing and administering methadone was changing to an oral type of methadone to be issued at the center, we required certain new security measures and procedures to insure that: (a) Methadone did not bleed-back to the streets. (b) Supplies were minimal and security was adequate. Testimony regarding certain other factors are a part of this total statement and are not to be repeated orally here at this particular time. I would say that the amount of methadone which is illegally on the streets, so far as we know, is minimal. This is especially so when you consider the amount of methadone illegally on the streets as compared to the amounts of other controlled substances that seem to be illegally available in Nebraska in the street scene of the drug problem. As long as methadone programs operate, however, there exists a real potential for deaths from overdose and certainly potential for diversion of this drug from legal to illegal channels and an increase in street inventory. Street clinics must be professionally administered as are those that exist in Nebraska at the present time. One of the most important reasons that this testimony can be accepted is that two of the programs are primarily inpatient programs and the third program, which is outpatient, in every case is a controlled program. It is a case where there is an outpatient program. It is orally administered. We give testimony that we from our agency believe this is mandatory. Cure ratios of heroin addiction, regardless of modality of treatment, are low. It is the opinion of the Bureau that there are, therefore, few individual physicians practicing in private or group practice situations utilizing methadone for private treatment of the heroin addict. I must hasten to add that the confidentiality of the physician-patient relationship may preclude our Bureau from hav ing knowledge of the extent of this practice, and I must testify that this fact limits the ability of a regulatory agency, such as ours, to ascertain the true facts regarding the existence of any such treatment. I remind the committee, however, that I have previously testified that we review the order form purchases allowed under BNDD. As an outside observer and recognizing that the objectives of these methadone programs in Nebraska have been to the benefit of the patient by providing an alternative to heroin addiction and to the establishment of a detoxification center which would avert withdrawal symptoms of heroin addicts, the Bureau has formulated certain opinions that I will complete my testimony by reviewing. Any program utilizing methadone in the treatment of heroin add iction should genuinely seek to detoxify that patient to a drug-free state. I know how difficult that is, but I have to give that testimony. This should be the ultimate goal, even in a maintenance situation. The Bureau would underscore previous testimony that this subcommittee has received that methadone is not the only modality of treatment for the heroin addict and to stress its limitations. Any program which seeks to provide detoxification and takes the patient to a drug-free state or maintaining state must be tightly administered and must insure that diversion is minimized, and just because we do not have extensive diversion at this time in Nebraska, the potential is certainly here. It is out opinion, therefore, that we would recommend that no one should be the administrator of such a program unless he is an M.D. and maintains a well-trained profes sional staff that is in close and daily contact in any methadone-administering program. I feel that the professional staff should to the fullest extent be trained in treating drug addicts and have more than just a passing knowledge of the drug culture. It is our opinion that any program which provides for self-administered dosages of methadone away from the center increases the potential for and, in fact, the diversion of methadone. In our opinion this would greatly increase the street existence of methadone. Oral administration at the methadone center is almost mandatory, in our opinion. Self-administered or take-home dosages should not be per mitted, or if they are permitted, they should be permitted at a level in the program where the addict has reached the point of where he is not using any other drugs and he is progressing toward a total abstinence to the degree that the potential for diversion and loss of control is very little. Clinics should operate a 7-day-a-week basis, because if you run a 5-day clinic, you have to provide take-home medication over the weekend. In certain circles methadone is looked upon as a panacea for the problem of heroin addiction. Testimony is given that methadone has many advantages through its utilization as a modality for treatment, but I remind this committee that it still falls in the category of a controlled substance. Methadone programs must be accompanied by certain laboratory procedures if they are to be effective at all. Our background knowledge of what occurred in Georgia, and other States, in this regard have brought us to the realization that without daily urinalysis checks, et cetera, that the methadone program has real serious difficulties. Methadone programs should not be simply dispensing operations but must be accompanied by certain counseling and therapy procedures. In summary, as a regulatory agent, I would testify to this committee that unless methadone programs are tightly run by a welltrained professional and experienced staff, the program may become useless to those they are treating and dangerous to the general public. We support Senator Cook's bill and recommend to the committee that it is just a matter of increasing, even with FDA regulations, a tighter control and therefore appears to add a dimension to the control in this regard, and therefore I favor its adoption. Senator HRUSKA. Mr higley, what is your personal background and experience in this general field? Mr. HIGLEY. I am a pharmacist by profession. I practiced pharmacy in the state of Nebraska for 17 years, and then I joined the Department of Health in November of 1969 as the Director of this Bureau. My training involved BNDD training and FDA training. Mr. HIGLEY. In the Bureau of Examining Boards in this area, and I will only talk about our staff in this area because we have a huge licensing responsibility, we have a chief investigator and three pharmacy inspectors and myself. Senator HRUSKA. Did you find that ample to take care of that segment of the Board's activities? Mr. HIGLEY. We have grown considerably, even though that is very minimal, in the last 3 years. No, I do not find it adequate, especially in the area of investigation of what is occurring now, Senator, in the pharmacies, the great increase we are seeing in the pharmacies of theft, burglaries, breakins, and so forth. The police handle it but we have a responsibility to report. Senator HRUSKA. You have indicated the surveys, the inspection. and the audits that your Board makes. Would you elaborate on the nature and the results of these surveys? Mr. HIGLEY. We work very closely with the Drug Control Division of the State Patrol, and we do routine and regular inspection of all pharmacies in the State of Nebraska. We do inspections in the hospital and nursing homes and physicians' and dental offices, and so forth, on what I term hotspot inspections where we have allegations. made that we have problem areas. We do a routine review of the order forms for purchases of controlled substances that require order forms which are schedule II. Wherever it looks like there has been an excessive purchase, we go in, Senator, to do an investigation. If we find at that point that the pharmacy, or whatever channel of legal distribution, may indicate that there could be possible diversion, and I emphasize "could be possible," we proceed on a drug-accountability audit. As you know, the Controlled Substances Act requires that there be an inventory level on May 25, 1971. Using that as a "Z" zero, and the requirement provides that all their purchases will be separate and apart from, we look at those records and determine what they purchased, we look at the dispensing records and determine what has been dispensed and come up with a figure of what their inventory should be on hand. We then do a regular routine count of that inventory and determine if there has been any diversion. We normally allow for a certain percentage of normal attrition loss and determine whether or not there has been a diversion. This is the procedure setup. I think that is all correct. Senator HRUSKA. You have indicated in your statement that there have been some instances of diversion from pharmacies. How did your department respond to that? Mr. HIGLEY. I want to be sure that I make my position clear. The diversion in pharmacies that we see is not extensive and the diversion from any medical area has not been extensive in Nebraska, but our response, of course, has been to take appropriate action with regard to these pharmacies. There has not been a lot in the pharmacies. The one case that comes to my mind immediately was a physician who was diverting drugs, and we did an audit on him and showed the diversion, and the appropriate action, through the Medical Board and the law enforcement people, was taken. Senator HRUSKA. Doesn't the Nebraska law permit a private practitioner to dispense methadone for detoxification to heroin addicts? Mr. HIGLEY Under the current law in the State of Nebraska, he can do this, but as a private practitioner under our current law, he is required to have counsel with two other physicians and register the name of the addict he is treating with the county attorney in the county in which he treats him. Senator HRUSKA. What is the purpose of the two other physicians? Mr. HIGLEY. Just to determine and to protect that it is not the singular judgment of the physician, Senator and that it is a necessary treatment. Senator HRUSKA. Of course, any physician under this arrangement is a potential and possible source of diversion. Has there been |