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representatives, and an end to samples of prescription products unless requested in writing and with detailed recordkeeping and accountability.
Further, in October 1975, PMA's board approved a set of “Guidelines for Programs of Technical Education and Training for Pharmaceutical Representatives” developed by a joint commission from medicine, pharmacy, and industry. The guidelines cover programs of study and other elements related to the initial and continuing training of professional sales representatives. They also formed the basis for a review mechanism. By early 1977, the commission had reviewed training programs of companies employing about 75 percent of the sales representatives in the United States. In general, these programs have been found to be highly professional.
Finally, it is important to consider the benefits derived from pharmaceutical company promotional activities. Obviously, patients benefit when physicians are made aware of therapeutic alternatives and understand their use and potential. History provides dramatic examples of the role pharmaceutical advertising, or the absence of it, can play in health care delivery: Failure to advertise a newly developed vaccine for diphtheria in the United Kingdom in the early 1930's resulted in thousands of catastrophes—some 3,000 deaths each year. During the same period, agressive promotion about the new vaccine and its use virtually wiped out diphtheria in the United States.
It is well recognized that the advertising of new products for the treatment of mental disorders through chemotherapy helped to make physicians more aware of the new therapies that revolutionized the treatment of mental illness in just a few short years. This new treatment dramatically reduced the number of persons who had to be hospitalized. Those now being treated instead in the community have more than tripled since 1961 to the incalculable benefit of the patients.
In summary, raw numbers of prescriptions for psychotropic medications do not indicate overutilization or unwarranted prescribing. Given the controls over promotional activities not only by Government but by the pharmaceutical industry itself, given the promotional performance record of individual companies, given the recognized use of noncommercial sources of information about drugs before prescribing decisions are made, and given the observed attitudes and practices of studied population segments on use of prescribed psychotropic medications, we believe that generally, such drugs are responsibly promoted, thoughtfully prescribed, and conservatively used by the vast majority of patients.
We agree that an unknown minor portion of patients overutilize these products. Society's challenge, it would seem to us, is to nurture an environment wherein such persons would be encouraged to admit inappropriate usage and seek treatment. Government's challenge may more logically be to insure that adequate treatment facilities are provided for their care.
Thank you, Mr. Chairman, for the opportunity to testify. We will be glad to answer your questions.
Mr. Evans. Thank you, Ms. Boe, and before we ask any questions of you, I ask Dr. Maronde if he would make his presentation and we will ask questions at that time.
TESTIMONY OF ROBERT F. MARONDE, M.D., PROFESSOR OF MEDI
CINE, SECTION OF CHEMICAL PHARMACOLOGY, UNIVERSITY OF SOUTHERN CALIFORNIA Dr. MARONDE. Thank you, Mr. Chairman. I am Dr. Maronde from the University of California School of Medicine, and I am head of the Department of Clinical Pharmacology, professor of medicine and of pharmacology.
For the sake of brevity, I would like to not read the entire testimony if it can be included in the record as submitted.
Mr. Evans. Without objection, it will be included in the record in its entirety.
[Dr. Maronde's prepared statement appears on p. 244.]
Dr. MARONDE. Briefly, we have studied abuse patterns of prescription drugs since 1967. This was first done at Los Angeles County-USC Medical Center, which is one of the largest medical centers in the United States, for ambulatory patients. We computerized the pharmacies and all prescriptions dispensed were put through the computer system prior to dispensing. We identified abuse patterns as shown on table 1, which we can look at on the second page. This briefly summarizes some of the findings.
In the first column is the drug name, Seconal, 100 milligrams, which is sold on the street for $1.50 to $2 a capsule. The highest quantity a year to a recipient was 1,280 capsules. The number of prescriptions this recipient or patient received to get this quantity of drug was 10, and four doctors were involved in writing these 10 prescriptions.
We go to Nembutal, called yellows, or yellow jackets, on the street, which sell for approximately the same price as Seconal. The highest quantity was 620 capsules in a year. Again there were 10 prescriptions, this
time by 7 physicians. We go to Librium, 25 milligrams, the strongest strength marketed, I believe. The highest quantity for a year to a recipient was 4,260 capsules, which is over 10 a day; number of prescriptions, 9; number of physicians, 6.
Valium,'5 milligrams, the highest quantity to a recipient was 3,142 tablets; total number of prescriptions, 42; number of physicians, 12. This lady was really a shopper. I shouldn't say “lady” at this time;
it may have been a man.
Miltown, meprobamate, the highest quantity a year to a recipient was 2,400 tablets; 13 prescriptions by a total of 6 physicians.
To try to quantify the problem a little more, we took a limit, which is an arbitrary limit; for Seconal, a hypnotic, we took 300 capsules in a year. We found 6.2 percent of the patients or recipients received over 300 capsules. This 6.2 percent accounted for 23.1 percent of the quantity of Seconal dispensed during a year.
The limit for Nembutal was 300 capsules, and 1.3 percent of recipients received over 300 capsules, accounting for 12.6 percent of the quantity. These drugs are used, as you know for sleep, one a night, and I don't think anybody would recommend them on a chronic basis.
Librium, 2.4 percent of recipients received over 600 capsules in a year, accounting for 16.1 percent of the quantity.
Válium, 1.6 percent of recipients received over 600 tablets in a year, accounting for 14.8 percent of the quantity.
And for Miltown, meprobamate, 6.2 percent of recipients received over 600 tablets, accounting for over 34 percent of the quantity dispensed.
In fact, these patterns presented in tables 1 and 2 were found for all drugs with abuse potential. We were the ones who found addiction to Darvon or propoxyphene by this method. One individual got 600 capsules in 1 week's time by getting multiple prescriptions through the emergency room and so forth. She was found dead on the street. A coroner's inquest found an excessive amount of propoxyphene in her liver.
I think most drugs that fall into this category are useful drugs. I don't think we should see their removal from the therapeutic armamentarium. This is happening in California. Valium has been removed from the medicaid formulary because of abuse by some.
We have solved the problem by placing these drugs in our computer file and by providing the pharmacist with the capability to recall prescription data before dispensing the drug, and we had
automatic alerts. We started with 100 tablets per month of Valium. When that was dispensed, it would ring an alert on the cathode ray tube and the pharmacist would pull out the old prescriptions and inform the physician and talk to the patient.
We are now at 50 per month. We haven't changed our patient population. We still have over a million patient visits a year. The only thing that has changed is the increase in Spanish surnames. We have cut hypnotic and antianxiety drugs 32 percent in this period. We have cut the dispensing of Librium and Valium, combined, 48 percent without having patient complaints. I don't think we have sacrificed patient care or caused any problem with physicians.
For the county of Los Angeles there is a saving of about $110,000 a year. Los Angeles County buys at a cost that is cheaper generally than the general retail or wholesale.
I feel that this system is no more sophisticated than the credit checks or check cashing with computer terminal presently in use in banks and supermarkets. And it has resulted, I believe, in maintenance of good therapy with control of our problem.
The next study derives from California medicaid drugs. The California State Department of Health recognized they had problems with abuse of drugs and they asked us to help define and quantify these problems. We found similar patterns to those formerly found at the medical center in the medicaid program, and I have presented them as an appendix.
Appendix À shows the distribution of Ritalin, methylphenidate, which is the No. 1 drug of abuse in Haight-Asbury. What we did was quantify the number of recipients who received specified quantities of Ritalin, 20 milligram tablets, in a 6-month period. And you can see one individual, on the medicaid program, got between 4,000 and 5,000 tablets.
It is this page [indicating].
The only two entities for which Ritalin is an accepted treatment are narcolepsy and hyperkinetic children, and I think its use in hyperkinesis is being questioned now because it causes emotional problems with some of the children.
We noticed that four recipients got between 2,000 and 3,000 tablets in a 6-month period. This drug is sold for $5 per tablet on the street.
At the Los Angeles County-USC Medical Center we have over 4,500 admissions each year for drug overdose. We are seeing patients who inject Ritalin intravenously. It hasn't been reported except in one study by one of my colleagues, Dr. Citron. It is there. It is a prevalent problem.
If we go to appendix B, the next page, this is for Tuinal, called rainbows on the street. They sell for about $2. The recommended dose is 100 to 200 milligrams nightly as needed for sleep. Six recipients got between 1,500 and 2,000 Tuinal in a 6-month period. Again, you can see that 14 percent received in excess of 150 capsules, and that's a lot.
Appendix C. This is for methaqualone, which is Quaalude. This is the 300-milligram tablet, a strong tablet. Two recipients received between 3,000 and 4,000 tablets in that period which is more than 20 a day.
Mr. NELLIS. At $2 to $3 it's not bad.
Dr. MARONDE. When 16 people receive between 1,000 and 1,500, that's a lot of Quaalude. And the 8.5 percent of the recipients who received in excess of 250 tablets accounted for 46 percent of all the Quaalude that was dispensed.
So I'm saying there is a finite population out there getting a lot of drugs.
I don't want to see all patients or all physicians penalized. I don't want to see restrictive policies for all and I don't think industry does either.
Mr. DORNAN. What is the breakpoint on the 46 percent?
Dr. MARONDE. In a 6-month period 8.5 percent of the recipients received in excess of 250 tablets. And this percentage of recipients accounted for the 46 percent dispensed during this period under the medicaid program.
The next one is secobarbital, "reds" or "red devils." They are sold again on the street for $1.50 or $2. The highest number one recipient received was between 1,500 and 2,000 in a 6-month period. It is the same pattern in that 9.1 percent of the recipients received in excess of 250 capsules. The largest number received by a recipient was between 1,500 and 2,000. If you break this down, 2.9 percent of the recipients would account for about 18 to 20 percent, I would estimate, of the quantity dispensed.
The same patterns occur outside of California—some people consider we have a State where these happen that are unique to the State. I asked Dr. Rucker of Ohio State University-this is on page 5, “The Private Sector”—for some studies on dispensing. He did this and gave me the information as part of a publication. He did studies on three Midwestern pharmacies in the private sector, and he found the same pattern. He found that as many as 800 Valium were dispensed by single prescription. This is in Columbus, Ohio. As high as 800 Librium, 10 milligrams, were prescribed by individual prescriptions; 22 percent of the prescriptions for Valium, 5 milligrams, and 24 percent of the prescriptions for Librium, 10 milligrams, were for quantities of 300 or more tablets or capsules.
So my conclusion is we have factual information of abuse patterns. We have solved these at the Los Angeles County-USC Medical Center by computer technology, and we have made the same recommendation to the State of California. I think they are receptive but, as you know, in any State government or any other government, it will take time to see how receptive.
Thank you, gentlemen. I will be glad to answer any questions you have.
Mr. Evans. Thank you, Dr. Maronde.
Mr. DORNAN. Doctor, I am very impressed with your work particularly because I was developing a little complex today about my home State. I thought maybe southern California was simply out of sync with the rest of the Nation and much more addiction prone. However, just now, going over to that last vote with Mr. Gilman, there were three young people on the elevator, 23, 25, and 30, one male—he was the 25-year-old-and two females. And I said, "Have you folks ever heard of Valium ?" Well, here are verbatim responses I received.
“Are you kidding?” They all chuckled, knowingly. I said, "Well, do any of your friends take them?"
"All of our friends take Valium." And they all laughed among themselves.
I said, “Are you kidding?"
They said, “No, we are serious." The male said, "If you go to a doctor, and you don't ask him for it first, he recommends it for you.
It's just all over the place.”
Then I asked their ages and I asked where they were from. I particularly want Mr. Gilman to hear where they are from. “Upper New York State," was the answer.
So whether it's an analysis of Columbus, Ohio, or upper New York State, I don't believe California is all that different from the rest of the country. We just start certain trends.
I wonder if we don't need regulation tightened here. I try to respect the free enterprise system-because I am a conservative, very much against more Government regulation. I must say that although I have great anger against the pharmaceutical industry and drug overuse, I am against crushing the pharmaceutical industry with more regulation.
Where do you place the blame? The patient asks for it, the doctor is prescribing profusely, the pharmacy is giving it out, and the pharmaceutical companies are overproducing. Where do you start?
Dr. MARONDE. Let me say I started out more of a crusader than I am at the present time. I have mellowed somewhat. I was quick to point fingers when I started.
Mr. DORNAN. There is a new drug called Mellaril. Can you elucidate? (Laughter.]
Dr. MARONDE. I found it was multifactorial the more I got into it. We found half the time it was the patient/recipient shopping, going around to different physicians. We found 3 percent of the patients shopping and abusing the system and accounted for 50 percent of the abuse. The other half is by individual physicians.