« iepriekšējāTurpināt »
solved by the two committees so that only one registration will be required.
Another part of H.R. 13743 affecting retail pharmacies is section 304 (d) which deals with denial, revocation or suspension of registration. This provision would permit the Attorney General at his discretion, to suspend a registration, thereby affecting a major part of the operation of a retail pharmacy, simultaneously with the institution of proceedings and prior to a proper hearing on the facts in a particular proceeding. It is understood that this right is presumed to be based upon "imminent danger to the public health or safety." In the case of retail pharmacies, however, such action might be circumscribed with additional safeguards, such as expedited hearings or suspension of registration as to only certain schedules. Section 304 (d) seems to deny a registrant a presumption of innocence.
RECORDS AND REPORTS OF REGISTRANTS
The intent and purpose of this legislation is to provide effective control of all drugs which are considered dangerous substances in the purview of the findings and declarations. It, therefore, seems inconsistent to exclude anyone who may own, possess or control such substances as the exemption in section 307 provides for practitioners who prescribe or administer, particularly as relating to schedule II substances. Since the definition of "dispense" in section 102 (k) would exclude a physician, by referring to "deliver *** by or pursuant to the lawful order of a practitioner," the exemption might fully excuse every physician from any recordkeeping requirement of section 307.
We think that such control is necessary and intended. Certainly anyone engaged in dispensing controlled, dangerous substances in all schedules should be required to maintain complete and accurate records for the drugs handled.
Section 307 requires that a complete and accurate record of all stocks of dangerous subtsances be made as soon as the bill takes effect and thereafter a 2-year inventory is to be carried out. We feel it is doubtful that the periodic inventory requirement is necessary at all, provided that registrants can make beginning inventories and subsequent records available.
The inventory requirement will be an unusually costly administrative burden on retail pharmacies. Such inventory and reporting procedures will probably have the unfortunate effect of adding to the cost of drugs. We can understand the reason for the 2-year requirement in the case of schedules I and II drugs but for schedules III and IV drugs it would prove to be an unnecessary, time-consuming and expensive proposition for pharmacies to comply, especially if accurate counts of each tablet or capsule are required. If it is felt that such a periodic. inventory is absolutely necessary, we feel that a 5-year requirement would provide adequate controls at the retail level.
Section 309 (c) provides that controlled dangerous substances included in schedule IV, generally known as the class of exempt narcotics, may not be distributed or dispensed other than for a medical purpose. Since the "dispensing" or "dispenser" definitions of this legislation cover basically the pharmacy and the pharmacist, it is questionable whether the phrase "medical purpose" adequately enables the pharmacist to perform the function intended in this section.
capable of and should be permitted to exercise his professional prerogative in handling the so-called exempt narcotics as provided for in We agree with the intent of this provision that the pharmacist is this proposed legislation.
Sncie the introduction of H.R. 13743, the Department of Justice has promulgated regulations to limit the sale of exempt narcotics to sales by pharmacists. Such a regulation has been recommended for many years by the Bureau of Narcotics. We hope that this regulation will correct the abuse pertaining to exempt preparations. We would not recommend that the new regulation be incorporated in the proposed legislation.
Section 403 prohibits shipment of controlled dangerous substances. We recommend that the prohibitions extend to mail-order prescriptions of schedules III and IV where there is an absence of patientpharmacist relationship that serves the public health interest.
OFFENSES AND PENALTIES
Section 502 provides for fines up to $25,000 for any offense, including failure to keep any record, order form, statement or invoice. Such penalty may be proper for many of the violations but is quite excessive for unintentional loss of some form or invoice when a variety of personnel in retail pharmacies will be responsible for keeping a multitude of such records.
THEFTS AND ROBBERIES
Many retail pharmacies have been robbed or burglarized by criminals searching for narcotics and dangerous drugs. Too many retail pharmacists have been murdered, blinded or assaulted as a result. With enactment of the subject legislation, there will, hopefully, be a substantial reduction in drug abuse. We are concerned, however, that the robberies, assaults and senseless murders in retail pharmacies may increase. It is our feeling that such criminal acts would be lessened if the Justice Department could take a greater interest in pursuing such cases. The deterrent would be accelerated. If only local authorities pursue these cases, the impact may not be great enough. Since the reason for the proposed legislation is the great national interest and social harm involved, the HARD recommends that consideration be given to ways for the Justice Department to become involved in cases where robberies of retail pharmacies are aimed at drugs and products which are the subject of these bills.
In conclusion, we appreciate the opportunity to express our views on this important legislation. We will be glad to provide any additional information or attempt to answer any questions that will be useful to the committee. The retail pharmacists of this country are very much aware of the current drug abuse problems and they are anxious to be of service to this committee and to help make the proposed legislation effective.
Mr. ROGERS. Thank you very much, Mr. Woods, for a very helpful statement.
Mr. KYROS. Mr. Woods, did you hear the testimony earlier about the zero inventory method this morning?
Mr. Woods. Yes, sir; I did.
Mr. KYROS. Are you in favor of that procedure instead of having all of the recordkeeping that you seem to be unhappy about in the legislation?
Mr. Woods. I am really not that familiar with the zero inventory. I have heard of it, but I am not that well acquainted with it.
Mr. KYROS. You complain, however, in your statement about the recordkeeping required for inventory.
Mr. WOODS. Particularly the inventory.
Mr. KYROS. What alternative would you propose?
Mr. Woods. I really doubt that an inventory is necessary on this schedule III and IV drugs if the pharmacist is providing the records that he has been accumulating along with purchases, and then also we suggested the possibility of a 5-year inventory.
It may be the zero inventory would answer the purpose, but I do think by the use of the requirements of the State along with a lessening of these requirements, would certainly alleviate some of the burden.
Mr. KYROS. You spoke about too many pharmacists who have been murdered, blinded, and so on. Do you have any figures on that; for example, for the year 1969 ?
Mr. Woods. I will be glad to try to obtain those figures. I do not have figures on that, but we get reports from time to time from the press and people we hear of and if we dry up the sources from legislation such as this, that would make the controls more effective, we would anticipate some problems.
(The information requested was not available to the committee at the time of printing.)
Mr. Woods. It is our understanding that where there is a large theft in a wholesale company or a manufacturer or something of that nature, the Justice Department does take an interest in it. But where it is a small retailer, they leave it up to the local authorities and that is the reason we brought it to the attention of the committee.
Mr. KYROS. Is it true in drugstores or retail pharmacies in many instances you have clerks there who sometimes steal the goods themselves and give them to their friends, especially when you have youngsters working for you?
Is that one way of getting illicit drugs on the market?
Mr. WOODS. I have no records on that, but the FDA records for diversion would indicate from their 10-year survey completed 5 years ago an average of something like 165 cases a year against retail pharmacies.
In some cases we understand it involved the type of drugstore personnel you are talking about. They may not have involved the pharmacist. I might say, too, this 165 a year during the 10-year period was less than 1 percent of the pharmacies of the Nation, so I don't think any substantial amount involves retail pharmacies. I think a lot of this illicit traffic comes from other and different sources that have been brought to the attention of this committee.
Mr. KYROS. On page 8 of your prepared statement you make the statement that "It is our feeling" speaking for the National Associa
tion of Retail Druggists, "that criminal acts against retail pharmacies would be lessened if the Justice Department could take a greater interest."
The problem, of course, is I think all of us today try to keep crime not only a local issue, but try to get local people to take care of local crimes. You are not urging that you would want to extend the jurisdiction of the Justice Department to take care of local robberies of local drugstores?
Mr. WOODS. No, sir; I would not want to go that far and I realize there are two sides to it, but it is my understanding that where there is a robbery of a warehouse or manufacturing group, that the Justice Department does take some interest in it. But if these criminals know the Justice Department is going to take no interest in surveying it or looking into crimes in retail pharmacies involving dangerous drugs, it may accelerate these crimes involving the retailers.
As I understand it now, Justice is taking no interest where there is a robbery of a retailer involving these drugs.
Mr. KYROS. That is the law as it is right now. I can understand your interest in having Justice get involved, but it would be an awful thing, it seems to me, if the Justice Department would have to put agents in almost every city and town for routine robberies.
Mr. Woods. I think the thrust of what we had in mind was bringing this to the attention of the committee. If something can be done about it or with it, we would appreciate it.
Mr. KYROS. On page 8 regarding the penalties of $25,000 for any offense, including failure to keep any record, you felt that kind of a sanction was excessive because the law reads in section 502, "It shall be unlawful for any person, among other things, to refuse or to fail to make" and there is no intention in that offense and you would want that changed because you think it is unduly harsh?
The trouble is if someone has failed to keep records and the Justice Department comes in and tries to make an inventory subsequently and the records have not been kept, then the Justice Department is obstructed from checking that particular pharmacy or particular hospital or particular person that was handling drugs. Do you follow me?
Mr. Woods. Yes, sir. I think if we had a real bad actor who was following a consistent course of action, that we would say "throw the book at him," but if it is an inadvertent loss or failure to keep some record or purchase record involving maybe a stockroom clerk
Mr. KYROS. In other words, you would say refuse or willfully fail to keep or furnish. You could use the word "willfully." This subject appears in the act on page 37, section 502 (a), subsection (h), so you would say to "refuse or willfully fail to make, keep or furnish ** ** is that right?
Mr. WOODS. Yes, sir.
Mr. KYROS. I think it is a point well made.
Thank you, Mr. Woods. Thank you, Mr. Chairman.
Mr. ROGERS. As we ask groups as they come in where they feel diversion comes from or illegal traffic, when you get to the manufacturers, they don't feel that any comes from there. Then we get the
wholesaler and they don't think there is any there, and then we get down to the doctors and they tell us it is not in that segment and the retail druggists now tell us there is none there.
Well, where do you feel all of this comes from? We have 900 agents supposedly to track all of this down and they come up with 4,000 arrests, five per man for the year. I don't know how society gets inundated with all of these drugs from no sources.
Where do you think it mainly comes from? I don't believe there are enough robberies out of warehouses to supply all of this.
Mr. Woods. I don't believe there are either. I think it is a factor and I can certainly appreciate your concern. I think, Mr. Chairman, that you put your finger on the real problem that has to be dealt with. I don't know the answer. I think there must be some way to determine this.
Mr. ROGERS. I think so, too, and I think this is what we have to do and I feel probably it is an enforcement problem. I wonder, for instance, with retail druggists, somebody has a prescription from a doctor on a weight problem. It is not really very serious.
Well, how many times can they go in and fill that prescription? Mr. WOODS. It depends on what the doctor orders.
Mr. ROGERS. Say it is amphetamines.
Mr. WOODS. Usually it is 6 months or five refills.
Mr. ROGERS. How often do you think that is adhered to?
Mr. WOODS. I don't think there is too much of it now. Of course, some other people have records on this, but the pharmacists are concerned about the problem and they are concerned about the loss. I don't think it is a significant factor of diversion. We never have a conference, a meeting, a national meeting that we don't have somebody from the Bureau of Narcotics and Dangerous Drugs or FDA on the program. This has been historical and we have made that type of effort to keep them informed and educate them and provide all types of materials for them.
Mr. ROGERS. When someone takes in a prescription to be filled, what is noted on that particular prescription?
Mr. WOODS. They keep this on file, the date that it was filled and who filled it. It is initialed by the pharmacists.
Mr. ROGERS. Is anything stamped on it?
Mr. Woods. The number is stamped on it and it is even used on refills.
Mr. ROGERS. Is anything stamped on the prescription that the person gives to the pharmacist?
Mr. Woods. The only thing the pharmacist would put on it would be the date and the number of the prescription.
Mr. ROGERS. In his own records?
Mr. Woods. That's right.
Mr. ROGERS. Does he make that notation on my prescription that the doctor gives me? Does he make any notation on this prescription? Mr. Woods. Nothing except who filled it and assigned a number. There is only one copy.
Mr. ROGERS. He keeps a record of all of the drugs he puts out, does he not?
Mr. WOODS. Yes.