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What it boils down to is that individuals choose different methods of coping with illness, and their choices are influenced by a variety of factors. They may decide to consult a physician, or they may choose to treat themselves in a variety of ways—with medicines purchased without a prescription; with liquor; with home remedies following folk practices; with visits to a faith healer or an encounter group; with training in transcendental meditation. They may use illicit substances, such as marijuana, PCP, heroin or cocaine, or illicitly obtained prescription drugs. Or they may choose to do nothing at all.
What are the factors that influence coping decisions? Most would agree that the severity of the illness exercises the greatest influence. As others have observed :
Coping begins with illness, and it is severe illness that propels people to the doctor." This same researcher continues to observe:
More basic considerations affecting that flow of persons into the treatment system are personal and cultural criteria of illness .. At what point does a person admit to illness? How does he label his illness? To what does he attribute it? How much discomfort or incapacity is he willing to tolerate? When does he admit to defeat or helplessness? At what point does he decide to seek help from the physician and adopt the sick role? What is being explored in these questions is the outline of a deep-seated characterological orientation akin to the puritan ethic. In a contemporary drug context this orientation has been termed "pharmacological Calvinism.”
Demographic factors, such as sex and age, in conjunction with more potent disease factors ... may play a significant role ... in determining both the type and proportions of persons ... who seek treatment at any given time. However, the number of persons in treatment is probably much less expandable than is commonly believed. (The) basic biological, social and economical forces .. involved—(are) ... ones that are not so readily influenced by sophisticated marketing and promotional activity. In the case of prescription pharmaceuticals, marketing and promotional activities are directed exclusively to the physician, a fact that is often overlooked in current dialogues about medication practices.
In recent years there has developed a highly generalized tendency to equate drug treatment with “the bad” and getting along without drugs with "the good." Yet the consequences of no treatment, in terms of personal costs to the individual, remain essentially unstudied in a whole range of self-limited illnesses of both short and long duration and in chronic conditions of lesser severity. If the sheer ability to survive or weather a storm of illness without drugs is the test of appropriate prescribing or responsible patient behavior,
then there is obviously little need for most pharmaceuticals.19 The researchers who made these observations also conducted studies on the "distribution of various public attitudes and beliefs about tranquilizing drugs, and the relationship of these attitudes and beliefs to use of psychotherapeutic drugs prescribed by a physician ..." Their conclusion :
In several studies in the United States, we have found attitudes toward tranquilizers to be essentially conservative ... One can entertain the idea that the drugs work very well and yet hold negative attitudes toward them,
as most Americans do.20 In summary raw numbers of prescriptions for phychotropic medications do not indicate over-utilization 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 non-commercial 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 over-utilize these products. Society's challenge, it would seem to us, is to nurture an environment wherein such persons would be encouraged to admit inappropirate usage and seek treat
18 Balter, Mitchell B., opt. cit., p. 32.
ment. Government's challenge may more logically be to ensure 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.
PREPARED STATEMENT OF R. F. MARONDE, M.D., PROFESSOR OF MEDICINE AND PHAR
MACOLOGY, USC SCHOOL OF MEDICINE, LOS ANGELES, CALIFORNIA
ABUSE OF PRESCRIPTION DRUGS
Abuse patterns of prescription drugs will be described. These patterns were derived from three sources: (1) Los Angeles County-University of Southern California Medical Center, (2) State of California Medicaid program, and (3) community pharmacies from the private section in a midwestern metropolitan area. Corrective measures have been implemented and have been effective.
LOS ANGELES COUNTY-USC MEDICAL CENTER
The pharmacies at Los Angeles County-USC Medical Center were computerized in late 1967. Under grants and contracts from the United States Health Services Research Administration, the Social Rehabilitation Service and the Social Security Adminisration, a comprehensive, computerized drug utilization review program was developed. At present the system is in full operation, and it is in the process of being extended to all health care facilities of the Los Angeles County Department of Health Services. Over one million ambulatory patient prescriptions per year are processed. Problems with abuse of prescription drugs were identified and corrective measures have been implemented. Abuse was apparent in a small percentage of health care recipients who received large quantities of psychoactive drugs by prescription.” Examples follow in Table 1:
The relatively small number of recipients who abused the health care system accounted for a 15–35 percent of the quantity of these drugs that were dispensed, as depicted in Table 2 : 2
The patterns presented in Tables 1 and 2 were found for all drugs with abuse potential. In fact, some drugs not commonly identified as abuse were so identified by these prescribing patterns.
1 Drug, Utilization Review With. On-Line Computer Capability: Selected Methodology and Findings From A Demonstration, U.S. Dept. HEW, Social Security Administration, Office of Research and Statistics, Staff Paper Nov. 13, 1973.
2 Prescribing Hypnotic and Anti-Anxiety Drugs. Maronde, R. F. and Silverman, M. Annals of Internal Medicine, vol. 79 ; page 452, September 1973.
2 Prescribing Hypnotic and Anti-Anxiety Drugs. Maronde, R. F. and Silverman, M. Annals of Internal Medicine, vol. 79; page 452, September 1973.
Corrective Measurements: Most drugs that fall into this category are useful medications. Their removal from the therapeutic armamentarium is not, in my judgment, the solution to the problem. We elected to place drugs identified as having abuse potential in our computer file and to give the pharmacists the capability to recall these prescriptions for review before a new prescription was processed. To further aid the pharmacist, an alert was added to let the pharmacist know, whenever a prescription was processed for one of the defined drugs, if an excessive quantity of this drug had been prescribed and/or if multiple prescriptions for several drugs with abuse potential had been prescribed over a specified time interval. The response time of this system is two to three seconds. This is no more sophisticated than credit checks or check cashing via computer terminal presently in use in banks and supermarkets. A 32 percent decrease in the quantity of psychoactive drugs dispensed has resulted. Most importantly, this was accomplished without the restrictive regulations or investigative personnel that might penalize all recipients and all physicians because of the abuse of the system by a few individuals. A side benefit associated with the use of this system is the prospective avoidance of potentially harmful drug-drug interactions.
CALIFORNIA MEDICAID DRUGS
The California State Department of Health recognized there were problems with abuse of drugs paid for by their Medicaid program. In 1978, they contracted with our group to identify more specifically and to quantify these problems and to help develop corrective measures to curb these abuses. Patterns similar to those found at Los Angeles County-USC Medical Center were identified. Four examples are included at the end of this report. Methylphenidate (Ritalin) is a drug with high abuse potential, but it has value in the treatment of narcolepsy and hyperkinetic children. During a consecutive 6 month period, 7.8 percent of recipients of methylphenidate, 20mg tablets, received in excess of 500 tablets accounting for 29 percent of all the 20mg tablets of methylphenidate that was dispensed, One recipient received in excess of 5,000 tablets within a 6 month period. The recommended maximum dose is three tablets daily. With Tuinal 200mg, a hypnotic sedative, 14 percent of the recipients accounted for 40 percent of the quantity dispensed. One recipient received between 1,500–2,000 capsules within a 6 month period (average between 8–14 capsules daily). For methaqualone (Quaalude) 200mg, 8.5 percent of the recipients received in excess of 250 tablets within a 6 month period and accounted for 46 percent of the quantity dispensed. One recipient received between 3,000_4,000 tablets (16–28 tablets per day). Finally, with secobarbital 100 mg, 9.1 percent of the recipients accounting for 48 percent of the quantity dispensed. One recipient received between 1,500–2,000 capsules.
Currently, over 90 percent of all prescriptions processed are being analyzed. Obvious abuse of prescription drugs is apparent. Corrective measures will require, in part, computer systems with similar capabilities to that described under the Los Angeles County-USC Medical Center system.
THE PRIVATE SECTOR
The pattern of excessive prescribing was apparent. Recipients had been dispensed as high as 800 Valium 5mg tablets and 800 Librium 10mg capsules by individual prescription. Twenty-two percent of the prescriptions for Valium 5mg and twenty-four percent of the prescriptions for Librium 10mg were for quantities of 300 or more tablets or capsules. Again it was found that a relatively small percentage of recipients accounted for disproportionately large quantities of these drugs.
Abuse of prescription drugs is apparent when prescription data are analyzed. Studies based on interviews would not reveal this abuse because of the reluctance of the recipient to reveal factual information. At LAC-USC Medical Center, modern computer technology has allowed us to control this problem without penalizing all recipients or all physicians. The system is cost effective and is now being extended to all of the health care facilities within the Los Angeles County Department of Health Services.
: Drug Utilization Review Paper, Maronde, R. F., in Perspectives on Medicine in Society ; Editors Wertheimer and Bush ; Drug Intelligence Publications, Inc., Hamilton, Illinois. 1978.
In our work with the State of California we have recommended that a Prospective Fraud and Abuse Drug Control System be developed. True control can only be established in the prospective mode. It is our opinion that both the computer technology and economics now exist to justify such system. Analysis of prescribing patterns demonstrates that abuse patterns are not confined to the Los Angeles County-USO Medical Center nor to the State of California.
APPENDIX A.-METHYLPHEN IDATE (RITALIN) 20MG (2625D)
Description : Methylphenidate has only two entities for which it is accepted for treatment. The first is narcolepsy, a rare disease. The other is hyperkinetic children. The prolonged chronic use in hyperkinetic children is now being questioned and severe adverse effects have been noted. Methylphenidate is probably the number one prescription drug being abused on the street. It is dissolved and injected intravenously. It has similar effects to “speed”. The price for one tablet of methylphenidate on the street can be as high as $10.00.
Distribution analysis: There were 3,258 recipients to whom methylphenidate was dispensed during the consecutive 6 month period that made up this survey. One recipient received over 5,000 tablets of methylphenidate during this time. Four recipients received between 2,000 4,000 tablets. Of the 3,258 recipients who received tablets of methylphenidate, 253 or 7.8 percent received more than 500 tablets during the 6 month period and they accounted for 29 percent of all the 20mg methylphenidate tablets that were dispensed.
State of California Department of Health, Medi-Cal Drug Claim [Quantity distribution by beneficiary for 6 mo. period, from June 1977 to December 1977]
Number of Quantity:
recipients 1 to 25.
33 26 to 75. 76 to 150_
886 151 to 250
456 251 to 350.
219 351 to 500_
290 6 month limit: 501 to 650_
117 651 to 800
69 801 to 900.
17 901 to 1,000.
15 1, 001 to 1, 500_
25 1, 501 to 2, 000.
5 2,001 to 3,000..
4 3,001 to 4, 000_
0 4,001 to 5,000.-
1 5,000 and over-Total.
APPENDIX B.-TUINAL 200MG CAPSULES (2162C) Recommended adult dose : 100 to 200mg nightly as needed for sleep. Recommended 6-month limit: 250.
Description : A 6-month supply, if a recipient took 1 capsule every night (this is excessive and would represent poor medical practice) would be 186 capsules. The habituating dose of Tuinal is between 200 and 400mg daily.
These capsules are sold on the street as "rainbows" for $2.00 each.
Distribution analysis: The number of recipients who received prescriptions for Tuinal 200mg within the consecutive 6 month period which made up this survey was 14,934. Of these 14,934 individuals, 2,091 or 14 percent received in excess of 250 capsules. The largest number of capsules a recipient received was between 1,500 and 2,000 capsules, or approximately 10 capsules per day.
The 14 percent of recipients who received in excess of 250 capsules, accounted for approximately 40 percent of the total number of Tuinal 100mg capsules dispensed.
State of California Department of Health, Medi-Cal Drug Claim (Quantity distribution by beneficiary for 6 mo. period, from June 1977 to December 1977]
Number of Quantity :
recipients 1 to 25..
980 26 to 75
6, 184 76 to 150
3, 576 151 to 250.
2, 105 251 to 350
932 6 mo. limit: 351 to 500_
684 501 to 650_
238 651 to 800.
116 801 to 900_.
42 901 to 1,000.
26 1,001 to 1,500_
47 1,501 to 2,000_
6 2,001 to 3,000.
0 3,001 ot 4,000_
0 4,001 to 5,000_ 5,000 and over.
APPENDIX C.-METHAQUALONE (QUAALUDE) 300MG (22530) Recommended adult dose : 150 to 300mg nightly as needed for sleep. Recommended 6-month limit: 250.
Description : A 6-month supply if recipient took 1 tablet nightly, would be 186 tablets. Chronic usage is not good medical practice.
Methaqualone is one of the most popular street drugs. These tablets are sold on the street as "ludes" or "quacks” for $3.00-$5.00 each.
Distribution analysis: The number of recipients who received prescriptions for methaqualone 300mg tables within the consecutive 6 month period that made up this survey was 10,187. Of those individuals, 867 or 8.5 percent received in excess of 250 tablets. The highest quantity dispensed to an individual was between 3,000-4,000 tablets. This approximates 20 tablets per day. The 8.5 percent of the recipients who received in excess of 250 tablets of methaqualone 300mg accounted for approximately 46 percent of all the tablets of methaqualone 300mg dispensed during this 6 month period.
State of California Department of Health, Medi-Cal Drug Claim (Quantity distribution by beneficiary for 6 mo. period from June 1977 to December 1977) Quantity :
Number of recipients 1 to 25_
1, 484 26 to 75_
4, 292 76 to 150_.
2, 381 151 to 250_
1, 164 6 mo. limit: 251 to 350.-
429 351 to 500
268 501 to 650.
86 651 to 800_
37 801 to 900
13 901 to 1000_
14 1,001 to 1,500_
16 1,501 to 2,000_
2 2,001 to 3,000.
1 3,001 to 4,000_
2 4,001 to 5,000. 5,000 and over