Findings Of Fact At all times pertinent to the allegations involved in this hearing, Respondent, Robert A. Lieberman, was licensed to practice medicine in the State of Florida. John P. Spanogle, an investigator with the Department of Professional Regulation since 1980 and with the Board of Medical Examiners prior to that back to 1975, in November, 1979, was requested by representatives of the Orlando Florida Police Department to work with their detectives in several ongoing drug investigations. Respondent was not the subject of any of those particular Orlando Police Department investigations. However, during the course of these investigations, Mr. Spanogle secured certain prescriptions for Class II controlled substances that were written by the Respondent. As a result of these prescriptions, Mr. Spanogle interviewed the Respondent on July 7, 1982, at Respondent's office. At the outset of the interview, Mr. Spanogle advised Respondent of the nature of the allegations and of his rights regarding being questioned. He found Respondent to be extremely cooperative and received full answers to the questions asked, as well as patient release forms and patient records as to the patients listed in the various counts of the Administrative Complaint. During the course of the interview, Mr. Spanogle and Dr. Lieberman discussed several of the doctor's patients and the prescriptions he had written for them over the period in question. Dr. Lieberman seemed surprised he had prescribed so many Percodan and other drugs and could not readily explain why he had written so many prescriptions. Only one of the doctor's former patients testified for the Petitioner at the hearing. This was Linda Gorsuch Creed, a/k/a Linda Clary Morgan, the individual described in Count I of the Administrative Complaint. Ms. Creed is a former drug abuser who started abusing drugs when she was 18 years of age. She is now 26. During the course of her drug abuse, she used such substances as heroin, Dilaudid, Demerol, and others, injecting them into her arms and hands. She first saw Respondent in early 1979 for the purpose of securing drugs. Dr. Lieberman did not know this, however, because her stated complaint was of not being able to have sex without pain. This, however, was false. During the first visit, she was examined by the Respondent and was nude except for the examination gown. She cannot state whether she had drug injection track marks on her arms, but imagines she did since she was using drugs at the time. She does not know whether Respondent saw them, if in fact she had them. Respondent denies noticing any track marks on the witness; and on the basis of the evidence as presented, it can be concluded, reasonably, that Dr. Lieberman was not aware that this patient was in fact a drug abuser. During the first visit, she asked for Dilaudid and Valium and was given a prescription for both. Several months later, she again visited Dr. Lieberman for the purpose of securing drugs. On this visit, she complained of cramps, which again was not true, but at the conclusion of the visit was issued a prescription for Dilaudid. Approximately four years later, she again visited Respondent for the purpose of procuring drugs. At this time, she was mainlining and presumes that she had tracks which she feels may have been seen by the doctor. However, she asked for and received drugs based upon her represented "illness" and the Respondent's examination of her. Just about this time, she was arrested for drug abuse. At the time of her arrest, she had a prescription bottle for Dilaudid and one with Valium in it, both of which she had received from the Respondent. While she was out on bond, she again went to see the Respondent and asked for drugs. He refused, however, to give her any at this time because he had finally become aware that she was abusing drugs. She saw him several times thereafter and, on each occasion, he gave her only legitimate prescriptions; and she has not taken any illegal drug since 1980. The testimony of Dr. Lieberman on this same patient is consistent with that of the patient herself, though from a different perspective. The doctor's records reflect that the first visit from this patient on January 10, 1979, concerned her claim that she had had no period for three months and was in great pain. Examination revealed that her stomach was distended. He did a pelvic examination and found that her vagina was inflamed and she had a vaginal discharge. He gave her antibiotics for the infection and suggested that she have a laparoscopy examination in which a light device is passed through the navel into the fallopian tubes. The conditions described by the patient, if true, are in fact painful. The lack of period can be extremely painful because as a result the organs are swollen with fluid. The vaginal discharge and the history associated therewith indicated a possibility of pelvic disease and an inflammation of the fallopian tubes. It was for this reason that the laparoscopy was suggested. Because it was obvious that the patient was suffering great discomfort and because of her representation that Dilaudid was all that helped her (she was allergic to codeine and aspirin), he prescribed that drug for her. It is significant to note here that her allergy to codeine and aspirin limited the painkillers she could take and, as a result, which he could prescribe. He states that at the time of the examination, he saw no drug tracks on her body and did not know that she was an addict. He cautioned her on Dilaudid's addictive propensity and wanted her to have the laparoscopy so as to get her off Dilaudid as soon as possible. Dr. Lieberman was again visited by Ms. Creed in March 1979, approximately two months after the first visit. During this second visit, in which she stated she again had no period in the intervening two months since the first visit, the examination reflected that her stomach was tender, as were her organs, as well. The doctor gave her a hormone to start and regulate her periods and Dilaudid for the pain. On each prescription, Dr. Lieberman prescribed 20 capsules of Dilaudid. This drug is for severe pain, and he prescribed it only because, in his professional judgment, he felt she was in pain severe enough to justify it. Wilda Sue Boudreaux, another of Respondent's former patients, went to see him in May 1979, for the treatment of female problems. Dr. Lieberman recommended she have a hysterectomy, to which she agreed. She went into the hospital on May 23, 1979, for that operation and a bladder tac with removal of preexisting adhesions. Both operations were successful, and she was released after seven days' hospitalization. Dr. Lieberman saw her several times during her postoperative course of treatment. The surgery was done during the second or third day she was in the hospital. After the surgery, she was having severe pain and complications with a nerve in her leg that had been nicked during the hysterectomy surgery. After she was released from the hospital, because of these conditions, she was in constant, severe pain to the point she could not walk. Pain radiated through her leg and her lower body. She communicated these complaints to the doctor and received from him a prescription for Percodan. The Administrative Complaint alleges she received prescriptions on June 4, 5 and 19 and September 4 and 12. Ms. Boudreaux admits having received all prescriptions except the one on June 5 and denies emphatically that she received prescriptions for Percodan two days in a row. At the time the doctor prescribed Percodan for her, he told her it was a strong drug and should be taken carefully. She requested it, however, because it was the only drug that helped her. A couple of months after this surgery, she developed a urinary infection which resulted in severe pain during urination. She also continued to have severe pain in her left side where the leg nerve damage was and repeated pain from the prior surgery. She went back to the Respondent for a follow-up visit, and he hospitalized her for further tests. As a result of the tests, it was determined that the pain was due to severe nerve damage and that the pain would continue for some extended time until the nerve damage healed. Ms. Boudreaux considers Dr. Lieberman to be a good doctor who was concerned about her as a patient and who, at the time he gave her a prescription, explained to her why she was having the problems, what drugs he was giving her and what the drugs were for. It is her opinion that, throughout the entire period of time she was in contact with him, he appeared to be concerned about her as a person, not only as a patient. Respondent's testimony regarding his treatment of this patient was consistent with hers. He first saw her in March 1979, when she had a complaint regarding constant vaginal bleeding, painful periods and, as a result, he determined that she needed a complete hysterectomy, including complete removal of the tubes and ovaries, and surgery for preexisting bladder problems. During that operation, she sustained damage to a nerve which resulted in constant pain in her leg and abdomen. Nerve damage is one of the slowest types of damage to heal. As a result, this patient experienced constant pain over a long period after the surgery. On top of that, she developed a urinary tract infection as a result of the bladder surgery. As a result, she was maintained on Percodan until the infection cleared up and the nerve damage repaired itself. In the doctor's opinion, all the prescriptions for Percodan were appropriate. It is important to note here and with regard to the other allegations not the date of the prescriptions, but when and how they were to be used. Ms. Boudreaux is a school bus driver and a very responsible person; and Dr. Lieberman felt it was appropriate to prescribe Percodan as he did for her to stockpile them so that she would not have to come back into his office so often. In fact, she did not come back after June 19 until September 4, almost three months later. At that point, she still had the nerve damage and the bladder infection was first discovered. Petitioner made much of the fact that there may have been a less addictive drug that could have been used, both for this patient and for Linda Creed. Respondent claimed, however, that, based on his knowledge of the case of the individuals, he had no reason to disbelieve them; and in the case of Linda Creed, when she said Dilaudid had worked previously, he prescribed that in good faith. There is no evidence to show he did other than that in any case. Regarding the allegations pertaining to patient Patricia Rousseau, the patient information reflects that when first seen by Dr. Lieberman, Ms. Rousseau was a 30-year-old waitress with one child. She appeared well kept and was the sole support of herself and her child and needed to continue to work. At the first visit on July 9, 1979, Ms. Rousseau came in for an abortion, which was accomplished. At the time of her release, Dr. Lieberman prescribed 20 Percodan tablets to be taken one every six hours because, in this case, he thought it was medically indicated. Ms. Rousseau indicated she was in severe pain; and, based on the doctor's experience, he was convinced that, as a result of the procedure followed surgically, the pain could last for at least five days, which was the time it would take to use 20 tablets, taking one every six hours. Dr. Lieberman saw Ms. Rousseau again in January 1980. By this time, she had gotten pregnant again and wanted another abortion. She advised him that she had been to a clinic for that procedure and had developed an ovarian cyst. When Dr. Lieberman examined her, he felt that she could have a cyst, which, in his opinion, is a painful condition, and gave her medication for it. Here, he feels Percodan was indicated because of the fact that the condition arose from a second abortion and the additional pain that went along with it. Along with this condition, she also had dismenhorreah, a condition manifesting itself in painful periods, which, according to the Respondent, can be extremely painful and, in some women, totally disabling. Considering the fact that the patient needed to continue to work, as she was the sole support of herself and her child and could not be bedridden because of her period for three to five days each month, he felt Percodan was indicated, which he prescribed 15 or 20 at a time once a month for use during her period. The quantities prescribed were not, in his opinion, excessive. An additional patient who visited Respondent and whose course of treatment was considered to be improper by Petitioner was Martha Star Curtis, whose first visit to Respondent was on July 27, 1978. She was complaining of lower abdominal pain which, upon examination, turned out to result from a pregnancy. On August 2, 1978, this pregnancy was aborted. Her medical history, taken by Dr. Lieberman, revealed a prior ectopic pregnancy in the right tube and a lost tube and ovary. The following year, she had a cyst removed from her left ovary. At her first postoperative checkup, three weeks after surgery, Dr. Lieberman noticed a small ovarian cyst. When she came back a month later, the cyst was larger and was very painful. This pain related to the cyst was magnified because of chronic pelvic inflammatory disease, and Dr. Lieberman proposed to do a laparoscopy. Ms. Curtis had previously agreed that if this procedure had shown anything irregular, the doctor could go in, check it out and take care of whatever problem existed on the condition that her reproductive capability not be removed. As it turned out, upon accomplishment of the procedure, the doctor discovered that Ms. Curtis had substantial internal scar tissue in her pelvic area which had attached itself to her bladder, tubes, ovaries, intestines, interior of the "belly" and other internal and pelvic areas. This creates almost debilitating, constant pain as scar tissue develops, which increases as the scarring advances. Movement makes it worse--even the simple movements of walking, turning, etc. Even when the scar tissue is removed, it comes back unless there is a hysterectomy. Contra to this theory is the testimony of the Petitioner's expert, Dr. Lewis, who opined that movement not of the individual, but of the organ, would create pain. This difference in opinion is not particularly significant, however, as it is hard to conceive how movement by an individual, unless undertaken with an extremely delicate step, would not result in movement of the organs. In any case, since Dr. Lewis did not examine the patient, was not familiar with her nature, her makeup, or her disposition, it is more logical to assume that the physician who treated her over an extended period of time would be more acquainted with her condition and with the results of her activities than would one who sits in his office examining merely records. In this case, therefore, the observations and opinions of Respondent, who treated the patient, who performed the surgery and who was familiar with the individual, prevail. It is also pertinent to note here that Ms. Curtis, at the time this situation was going on, had met a man she intended to marry and bear children for. As a result, she did not agree to have the needed hysterectomy that was the only procedure that would cure the problem and remove the pain, at least until such time as she conceived and bore this man a child. Therefore, under those circumstances, in the opinion of the Respondent, Percodan was appropriate. Even though they are frequent and repeated, in his opinion, in light of her circumstances, her mental, physical, emotional and situational needs, this regimen was called for. While the Physician's Desk Reference indicates the standard dosage of Percodan as one every six hours, it also provides that this dosage can legitimately and should be exceeded when the situation calls for it. It is pertinent, also, to note here that Ms. Curtis at this time was traveling with her intended husband, a truck driver, in his truck, a situation which created more pain than would normally be experienced, and because of that could not come into the doctor's office as often as necessary. Therefore, in light of the fact that she would not agree to the only procedure that would alleviate her pain, the hysterectomy, and insisted on traveling with her putative husband, it was imperative that she receive relief from the pain, and Percodan was the only thing that would do it. Dr. Lieberman also treated a Julie Londy, first on August 18, 1980, when she came to see him, complaining of chronic pelvic pain, chronic bleeding from the vagina and painful periods. This lady was married, wanted no children and desired a hysterectomy. She entered the hospital for that procedure on April 22, 1980, and had a total abdominal hysterectomy plus an appendectomy on April 24, 1980. She was discharged on May 3, 1980. The conjunction of two major surgical procedures may have increased her pain, and her pain may have carried over from the previous condition she was experiencing, thereby reducing her tolerance for pain. Dr. Lieberman prescribed Tylox on three separate days within a six-day period, May 3, 7 and 9, 1980. Tylox is a Class II drug which is indicated for the reduction of pain. The generally accepted dosage is one every six hours, except in extreme discomfort, when the dosage can be increased. In this case, Ms. Londy was experiencing great pain because, coincident with her recuperation from the hysterectomy and appendectomy, she was experiencing a bladder infection; and, since she is allergic to codeine, Demerol, Dilaudid and aspirin and had told Respondent that Tylox was the only medication that would relieve her pain to which she was not allergic, he prescribed that substance. The first prescription was given on May 3, 1980, the day of her discharge from the hospital, and consisted of 40 pills. That should have lasted for ten days at the normal rate. The second prescription, for 30 pills, was given four days later because she was experiencing great discomfort. The third prescription, for 40 more, was administered on May 9, 1980, at her regular follow-up visit, after which the doctor was not to see her again for at least a month. It was his intention, by prescribing so many pills at one time, to give her a restful postoperative recovery; and the large number of pills was an advance. As a matter of fact, after May 9, the doctor did not see her again until late June 1980, some six weeks after the date of the last prescription. At that time, she was experiencing no pain, and neither asked for nor received additional narcotics. Respondent first saw Marilyn Quantrill on February 1, 1977. At that time, the patient, a 21-year-old female, was in early stages of pregnancy and wanted an abortion. This procedure was accomplished on February 7, 1977. Shortly thereafter, she got pregnant again and, despite the fact that she was being beaten by her husband, she decided to have the baby and did. Her husband continued to beat and emotionally abuse her (threats to take the child) to the point that she was a "nervous wreck." When she came to see Dr. Lieberman for the Seconal on July 17, 1978, her condition was such that she could not sleep because of her relationship with her husband, and Respondent gave her the Seconal to help her sleep. She was experiencing difficulty in coping with stress, and this condition is made worse by lack of sleep. She needed to sleep, and he gave her the pills in question to help her sleep. He thought his prescription for one pill per day at night for sleep was appropriate. The total number of Quaaludes prescribed over the five-month period was 210 pills. The period in question accounted for approximately 163 days. This is slightly over one pill per day, not notably excessive. It is also noted that Dr. Lieberman initially prescribed Seconal, thereafter switching to Quaaludes. He discontinued the Seconal because it was not strong enough to provide the necessary effect in light of her situation. It is also noted that Ms. Quantrill's husband was reported to be a drug dealer. When Dr. Lieberman found out this was the case, he not only stopped providing drugs for Ms. Quantrill, he declined to take her as a patient any longer. In the case of patient Stormy Druga (Smith) who received a drug called Eskatrol on three different occasions for weight loss, the allegation is not that the doctor prescribed improper amounts of the drug, but that the drug was prescribed for a purpose not permitted under Florida Statutes. Dr. Lieberman admits prescribing the drug on the date set out and the amount. He had used this drug for this patient before because she was overweight. She had just had a hysterectomy, was getting a divorce and desperately wanted to lose weight to improve her appearance. The prior use was successful in that she lost 30 pounds. Though Dr. Lieberman subscribed to numerous publications, he did not know that Florida had changed the law, prohibiting the use of Eskatrol for diet purposes. During the period in question, from August through November 1980, Ms. Druga came in every month for a weight control regimen, and he prescribed 30 pills each visit for a total of three visits. Unknown to him, the Florida Legislature had recently changed the law, prohibiting the use of any amphetamines or sympathomimetic amine drug or a compound designated as a Schedule II controlled substance, except for certain conditions of which weight control is not one. The first notice that Dr. Lieberman had that the law was changed was a bulletin issued by the Department of Professional Regulation in February 1981, three months after he stopped the prescription. In that regard, Dr. Lewis, the Petitioner's witness, stated that according to his experience, a doctor becomes aware of a change in one of several ways: (1) drug company flier, (2) a pharmacist's comment, and (3) national subscription-type letters. However, the State does not normally send out any bulletins regarding changes at the time the change is considered or initially made. Under these circumstances, it is quite likely that Respondent was not aware of the fact that the law had changed, prohibiting the use of Eskatrol for weight control purposes, during the time he prescribed it for Ms. Druga, as alleged. Each allegation against Respondent was evaluated by an expert in the field of obstetrics/gynecology for both Petitioner and Respondent. Petitioner's expert, Dr. Lewis, concluded, with regard to Ms. Rousseau, at least, that Respondent's charting is weak; he did not indicate on the record if the patient was seen on any of the visits which resulted in the issuance of a prescription and that Percodan, in this case, was prescribed without any clinical entry of observations on the records. On the other hand, Respondent's expert, Dr. Harry J. Stone, concluded that Percodan was appropriate in both the substance and the amount prescribed for Ms. Rousseau, a total of approximately 320 capsules over a two-plus-year period. If, as was claimed by Dr. Lewis, none of the prescriptions are charted, even that does not constitute malpractice because, according to Dr. Stone, in the practice of obstetrics end gynecology, quite often medications are not charted when the doctor is called out on an emergency situation before he can put it on the chart. As to Ms. Druga, Dr. Lewis indicated that Eskatrol was withdrawn from market use for weight control in 1980 because so much got into the Black Market and because of the undesirable side effects of amphetamines. The records examined by the doctor, which cover a period of time not alleged in the Administrative Complaint, show that over a period consisting of one year, five months and 21 days, Ms. Druga received 480 capsules and diuretics with a total weight loss of 10 pounds. While this is not successful weight loss maintenance, it is nonetheless not unusual depending upon the individual. Dr. Stone, himself, did not know of the change in the law regarding Eskatrol when it went into effect on July 1, 1980, and in his opinion, knowledge of this change within the medical community was poor. Both experts are in agreement that the State does not notify doctors of the changes, as the federal government does. The notices generally go to the pharmacists and, as a courtesy, the pharmacist should have called the Respondent, especially since the prescription here clearly stated it was for diet control. There is no question that prescriptions were issued for Eskatrol by Dr. Lieberman at a time when the law had been changed to prohibit the use of that drug for weight control purposes. It is equally clear, however, that Dr. Lieberman was unaware of the change and that insufficient effort was made by the State at the time to provide knowledge of the change to the various physicians. Turning to Ms. Quantrill, Dr. Lewis feels that because the patient came in and requested Valium and thereafter, as indicated in her letter to the Respondent, took 30 milligrams at one time, which is an excessive dose, Respondent should have suspected that she was likely to abuse drugs. She received prescriptions for 210 Quaalude capsules within a 163-day period. Dr. Stone, on the other hand, opined that the amounts in question were justified based on the emotional strain the patient was undergoing, as well as the pain from her condition. As to Ms. Creed, Dr. Lewis feels that when a patient asks for a particular Class II drug, that is characteristic of an addict, and he does not believe that Dilaudid was called for when Respondent administered it. On the other hand, Dr. Stone, based on the medical records he reviewed, including patient's case history, feels that under the circumstances of the first visit, the prescription of Dilaudid was appropriate in both substance and amount because of the acute pain associated with chronic pelvic disease. The antibiotics that were prescribed by Dr. Lieberman to cure this condition take a long time to work, and the patient needs help to stand the pain. If Dilaudid had worked in the past, it was not inappropriate to use it again. As to the second visit when Ms. Creed got Dilaudid, Dr. Stone feels that again the drug and the amounts prescribed were appropriate for much the same reasons. As to Ms. Boudreaux, Dr. Lewis feels that Respondent's records do not show any complications, and he feels that the drugs prescribed were too much in quantity for an uncomplicated postoperative course. It should be noted here, as elsewhere, that Dr. Lewis, in examining Dr. Lieberman's records, is at times very critical of them as being not complete enough, but at other times relies on them to support his viewpoint. For example, the witness uses the number of pills listed in the record to support the conclusion of over prescription without knowing the patient or having seen her, but when asked if the records say that Respondent stopped prescribing the drugs, this same witness states, "But we don't know what transpired because it's not in the record of what he saw the patient about, whether a medical problem or a drug problem." Dr. Stone, on the other hand, is of the opinion that the prescription of Percodan for Ms. Boudreaux was appropriate because of the combination of the two operations., the insertion of a painful catheter for a long period (six days) , the infection (which was painful) and the nerve injury (very painful). Because of the second hospitalization for the infection in September, Dr. Stone feels that the Percodan prescribed in September and October was appropriate. There does not appear to be an opinion from Dr. Lewis on the treatment given to Ms. Curtis. Dr. Stone, however, opines that the Percodan prescribed by Respondent for this patient from March to July 1979, was justified because of the repeated surgery. A second operation in the same area as former surgery is very painful. This drug can be given and was given at a prescribed rate of one every four hours as necessary for pain. In the opinion of Dr. Stone, this is reasonable, even though the Physician's Desk Reference calls for administration of one every six hours. In addition, continued use, which admittedly this patient had done, develops a tolerance which can result in raised usage. Therefore, even though Dr. Lieberman prescribed 830 pills over 121 days, a rate of almost seven a day, while higher than normal, this is not so aberrant a prescription rate under these circumstances as to be considered necessarily inappropriate or constitute substandard practice. Dr. Lewis also did not give an opinion as to Ms. Londy, for whom Tylox was prescribed. Dr. Stone, on the other hand, felt that the use of Tylox in the amounts prescribed was justified. Here, the patient had undergone major surgery, including an appendectomy, had had implanted a drain and had developed a fever, which indicates infection, with swelling and pain. All of these conditions justify the use of the drug in the amounts. Though the total quantity may seem high, it should be noted, however, this was only for a short period, and the pain of all the surgery and the patient's condition under these circumstances rendered this prescription in this amount not necessarily inappropriate. Based on his overall evaluation of the various patient records and his knowledge of Dr. Lieberman gained from observing him on staff at Florida Hospital and Respondent's excellent reputation as a gynecological and obstetrical surgeon in his community, he is satisfied there has been no gross or repeated malpractice in what Dr. Lieberman has done. Further, his review of the records reveals no indication of fraud, trickery, or any of the other alleged deceptive representations or any indication of bad faith on the part of the Respondent. Petitioner offered no evidence of these latter characteristics. Turning to the issue of medical stockpiling, however, Dr. Stone is quick to admit and recognize that the stockpiling of medicines as was done here in some cases by this Respondent is not a good idea. However, in the world as it exists, it may in some cases, and he is of the opinion that it was in the cases here, be acceptable practice, and not malpractice. Respondent, who has treated approximately 10,000 patients since he entered medical practice in 1976, routinely prescribes controlled substances in his practice. When he does so, he uses a high degree of care because of the addictive nature of Class II drugs. Before prescribing, he considers the individual and their medical problem needs. Modern OB/GYN practice allows physicians in these specialties to serve as "full" physicians to women, and they can treat their patients for illnesses other than those related to the OB/GYN practice. Under this situation, the doctor is required to also consider the emotional, physical, psychological and socioeconomic needs of his patients. It is wrong to merely consider records. A doctor treats people.
Recommendation On the basis of the above, it is, therefore, RECOMMENDED: That the Administrative Complaint against Respondent, Robert A. Lieberman, M.D., be dismissed and no disciplinary action be taken against him on the basis of the activity alleged in this Administrative Complaint. RECOMMENDED this 31st day of January 1984, in Tallahassee, Florida. ARNOLD H . POLLOCK Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 FILED with the Clerk of the Division of Administrative Hearings this 31st day of January 1984. COPIES FURNISHED: Barbara K. Hobbs, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Herbert M. Hill, Esquire Thomas Michael Burke, Esquire Post Office Box 1873 Orlando, Florida 32802 Mr. Fred Roche Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Ms. Dorothy Faircloth Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
Findings Of Fact Petitioner is a pharmacist doing business as Dyal's Pharmacy in Daytona Beach, Florida. Petitioner is a Medicaid provider under the rules of the Respondent, operating under Provider No. 1018147. Respondent is a department of the State of Florida, with its principal office in Tallahassee, Leon County, Florida. Respondent is designated as the state agency responsible for the administration of Medicaid funds, and is authorized to provide payments for medical services, pursuant to Section 409.266, Florida Statutes. Pursuant to his responsibilities as a Medicaid provider and a pharmacist, Petitioner has, during the period of March, 1982, through August, 1983, filled 43 prescriptions for nonsteroidal anti-arthritic drugs other than buffered aspirin, which did not have the words "medically necessary" written on the prescription form by the prescribing physician in his own handwriting. Petitioner filed claims with Respondent with regard to the aforementioned prescriptions, and Respondent paid $854.44 to Petitioner as reimbursement. By letter received by Petitioner on December 27, 1983, Respondent has notified Petitioner of its intention to seek repayment of that amount pursuant to Rule 10C- 7.42(4)(b), Florida Administrative Cede. Rule 10C-7.42, Florida Administrative Code, provides, in pertinent part, as follows: (4) Covered Benefits * * * (b) All prescriptions for buffered or enteric coated aspirin must indicate that an arthritic condition is being treated and dispensed in quantities no less than 200. Any nonsteroidal anti-arthritic drug, other than buffered aspirin, must have `medically necessary' written on the prescription by the practioner in his own handwriting. Noncompliance will warrant recoupment. Petitioner has sought an informal hearing regarding Respondent's attempt to recoup amounts previously paid to Petitioner, but in light of the provisions of the challenged rule it is unlikely that he can prevail. The existence of Rule 10C- 7.42(4)(b) is the only basis upon which repayment could be demanded by Respondent from Petitioner. The Florida Medicaid Program is administered through Respondent. In order to receive federal matching funds, Respondent must implement certain mandatory services for indigent. Other services which may qualify for federal funds are optional, and the state may cheese not to implement those programs. The pharmacy program, which this rule purports to regulate, is one such optional service which the State of Florida has chosen to implement. Funds utilized in the Medicaid Program are controlled by the legislature through funding of Respondent's budget. To regulate its budget, Respondent regularly reviews utilization and implements cost containment in various program. In 1981, Respondent was required to reduce its budget, and approximately $2 million of that reduction was required to be made in the Medicaid Program. In considering various options to reduce the Medicaid budget by this amount, the Department reviewed the pharmacy program budget which is the third largest in the Medicaid Program. Options such as limiting the number of prescriptions and requiring full payment were considered since these options had been implemented in other states. Such restrictions were not initiated, however, because Respondent felt that the large elderly population in Florida would forego taking necessary medication and endanger their health. Specific medications which were being paid for through the prescribed drug program were reviewed and certain drugs were eliminated from reimbursement under the program when prescribed for specified reasons, and other drugs were eliminated completely. These categories eliminated were chosen which would have the least detrimental effect on recipients. Additionally, Respondent, in consultation with physicians and pharmacists, considered the use of nonsteroidal anti-inflammatory drugs for the treatment of arthritis. While the drug of choice for treatment of arthritis is aspirin, because it is more effective than most nonsteroidal anti-arthritics, these nonsteroidal anti-arthritic drugs may be necessary for some patients who can't take aspirin. The number of persons who require such drugs instead of aspirin is small, however, and would not justify the large percentage of prescriptions for the nonsteroidal anti-arthritics which Respondent had observed through administering the pharmacy program. Because of their relatively high cost, nonsteroidal anti-arthritic drugs were accounting for 9.6 percent of the pharmacy program budget. Instead of eliminating the entire category of nonsteroidal anti- arthritic drugs from reimbursement under the program, which some states have implemented, Respondent opted to add aspirin to the list of covered benefits when prescribed for arthritis, and to require that the term "medically necessary" be written by the physician on the prescription form for nonsteroidal anti- arthritic drugs in order to be eligible for Medicaid reimbursement. This procedure was initiated in an effort to direct physicians' attention to the cost differential between the two types of drugs to ensure that a physician was making a conscious decision when prescribing the more expensive nonsteroidal anti-arthritic medication. The term "medically necessary" was chosen because physicians were familiar with that phrase through its use under the Florida Generic Drug statute. In response to an inquiry from the Florida Medical Association concerning the use of the term "medically necessary, Respondent indicated to that group that the term "drug of choice" would be an acceptable alternative. The challenged rule had not been amended at the time of final hearing in this cause to reflect this alternative term, nor was there any indication of record that any group other than the Florida Medical Association had been notified of Respondent's policy choice in this regard.
Findings Of Fact Respondent Newell Jerome Griffith is a licensed physician and, at all times pertinent to this proceeding, was engaged in the practice of medicine at Winter Haven, Florida. (Testimony of Respondent) During the period 1979-1980, Respondent's investigator, Lawrence E. Dodd, Jr., conducted routine audits of pharmacies in the Winter Haven area. The purpose of his audits was to review prescriptions for controlled substances in order to determine if irregularities had taken place in the prescribing and dispensing of such substances by pharmacists and physicians. During the course of these audits, Dodd found that Respondent had issued a large number of prescriptions in preceding years for various controlled substances which fell into the category of Schedule II under Chapter 893, Florida Statutes. The prescriptions in questions were prescribed for and obtained by Gerald Cooney, Annette Groover, and Peggy Moore. (Testimony of Dodd, Petitioner's Exhibits 1- 9) The following facts relate to each of the above named individuals: Gerald Cooney Respondent has treated Gerald Cooney as a patient since approximately 1974. Medical records reflect that Respondent treated Cooney for a medullary sponge kidney or similar chronic urinary infection, and acute and chronic recurrent infection of the left knee area which originally had been caused by a bicycle injury and was aggravated by shrapnel wounds in the same area during wartime service in 1970. Since that time, he has had multiple problems with his left leg requiring hospitalizations and has had a chronic recurrent cellulitis. Be has never had full use of the extremity since that time and has had recurrent swelling and extreme pain requiring narcotics. To alleviate the pain, Respondent prescribed both oral and injectable Dilaudid. In 1977, Respondent referred Cooney to the University of Florida College of Medicine regarding his renal difficulty. On April 1, 1977, Respondent wrote the Chief, Division of Urology, at the College that Cooney continues to require, and receive oral Dilaudid in amounts greater than I am comfortable with, but see no alternative to prescribing." On April 7, 1977, the Division Chief wrote Respondent that he had been unable to find any reason for Cooney's protracted pain requiring narcotics. In July 1978, Cooney was admitted to the Veteran's Hospital in Tampa for urinary tract infection and underwent a cystoscopy. The patient was discharged with instructions to return to Respondent for treatment of his "narcotic dependency." Respondent's office notes on February 19, 1979, stated that Cooney had been taking from 14 to 24 Dilaudid tablets daily and was able to make a reduction in dosage for a day or two, but then exacerbation of all illnesses recurred. The medical records further reflect a letter written by Respondent on August 17, 1979, "To Concerned Treating Physician or Physicians" which stated that Respondent had been treating Cooney for Dilaudid abuse which had come about because of symptoms associated with his left knee and urinary problems. In September of 1978, Cooney was again admitted to a Veteran's Hospital for a urinary tract infection, sponge kidney, and Dilaudid addiction. The attending physician noted that since Cooney's dependency had not been treated by his private doctor in Winter Haven, after his last discharge, it was decided that it should be treated at that time by withdrawing Dilaudid. Cooney, however, disagreed and was discharged to be treated at a drug center in Orlando. He did not seek such treatment but obtained further prescriptions for Dilaudid from Respondent. During the period November 1976 to June 1979, Respondent prescribed over 12,500 tablets of Dilaudid 4 mg for Cooney. Additionally, Dilaudid was prescribed in injectable form in the amount of 2 mg./cc. 14 x 20 vials. Between July and December 1979, Respondent prescribed over 2500 tablets of Dilaudid 4 mg, and 24 tablets of Dilaudid 2 mg. Between December 1979 and January 1981, Respondent issued prescriptions to Cooney for almost 7500 tablets of Dilaudid 4 mg, and a prescription for 20 1 cc ampules of injectable Dilaudid. Dilaudid is a Schedule II controlled substance listed under Chapter 893, Florida Statutes. It is customarily used for pain and has addictive qualities. Respondent is of the opinion that there was no alternative to the treatment which he gave to Cooney. He recognized that the patient was addicted to Dilaudid and attempted to assist him with detoxification in 1976. At one time, Cooney was taking as many as 20 tablets per day and, although Respondent limited him to between 16 to 20 tablets per day, he acknowledged that this amount was excessive. Respondent had prescribed other drugs for the patient, but he had allergic reactions to them. (Testimony of Dodd, Deatsch, Respondent, Petitioner's Exhibits 5, 6, 9, Respondent's Exhibit 1) Annette Groover Annette Groover has been a patient of Respondent's for over 26 years and was once employed by him as a nurse's assistant and receptionist. During this period, Respondent treated her for severe migraine headaches and seizure disorder. During the course of treatment, Respondent referred the patient to neurologist for consultation at various times who placed her on anticonvulsive medication. Respondent had prescribed Talwin for the patient's headaches, but in 1970 he became aware that she had used the drug excessively and for feelings of depression at times rather than for headache relief. In September 1979, Respondent's office notes reflect that Groover had been using a Variety of medications including Talwin, and that she had revealed that if she did not take the drug "her legs start to tremble, nose starts running, and I get jittery." Respondent thereafter counseled the patient regarding drug habituation and she thereafter was successful in withdrawal from Talwin. He then placed her on a regime of injectable Demerol because other drugs did not provide headache relief. In 1977, a consulting neurologist examined the patient and characterized her headaches as a chronic problem which was most likely related to tension. Between November and June 1979, Respondent prescribed for the patient more than 1850 cc. of injectable Demerol, 50 mg./cc. In addition, 12 tablets of 50 mg. Demerol and 100 tablets of Dexedrin Sulphate, 5 mg., were prescribed. Between July 1980, and November 1980, Respondent prescribed 66 2 cc. vials of Demerol, 100 mg./cc. Although Respondent's patient records do not reflect that Respondent examined Mrs. Groover between October 7, 1977 and March 23, 1978, he issued 29 prescriptions for injectable Demerol to her during that period. Respondent maintained at the hearing that his treatment of Mrs. Groover was legitimate and that she has never shown any withdrawal symptoms during periods of several weeks when she has gone without the drug. Mrs. Groover's husband is a medical technician in the Naval Reserve and normally administers her Demerol injections. Although she has tried other drugs, most of them have conflicted with her seizure problem and Demerol does not affect her in that manner. Demerol is a Schedule II controlled substance under Chapter 893, Florida Statutes. It is a central nervous system depressant which relieves pain, but is addictive. (Testimony of Respondent, Groover, Dodd, Deatsch, Petitioner's Exhibits 1-2, 7) Mary E. (Peggy) Moore Mrs. Moore is a legal secretary who has been a patient of Respondent for over 20 years. Respondent has treated her primarily for diabetes and pancreatitis. Over a number of years, she was hospitalized several time after referrals by Respondent to gastroenterology specialists. Demerol was prescribed both by Respondent and specialists to control the pancreatitis attacks. Her medical records reflect that she has been subject to episodes of hypoglycemia-- insulin reaction, usually complicated by epigastric pain and vomiting. In December 1979, after Mrs. Moore had been admitted to the Winter Haven Hospital for insulin reaction, the gastroenterologist who treated her stated in his report that the patient takes an appropriate amount of properly monitored narcotics in the form of Demerol at intervals of one to three months when experiencing pain from pancreatitis. Respondent also prescribed Quaaludes for Mrs. Groover in order that she could sleep because she had been under extreme pressure and stress. She took two tablets at night off and on for two to three years. She needed Demerol in the past at particular times when she had pancreatitis attacks. In 1980, Respondent referred her to Emory University Diagnostic Clinic and it was discovered that diabetic neuropathy was causing pain rather than pancreatitis. She is not taking Demerol at the present time and no longer suffers from her former attacks. During the period when she took Demerol, her daughter who was a registered nurse administered the injections and later her husband performed this task. On one occasion in 1978, her Demerol supply was stolen when she was on a trip. During the period when she was using Demerol, her husband destroyed any that she did not use between attacks. Respondent testified at the hearing that Demerol did become a problem with her before she went to Emory University Clinic, but she has not used it since that time. Demerol is a Schedule II controlled substance under Chapter 893, Florida Statutes. Quaaludes are a sedative and also a Schedule II controlled substance which is suitable periodically for sleep, but the patient is subject to rapid tolerance of the drug. One-half tablet of 300 mg Quaalude is usually sufficient for infrequent users. Mrs. Moore terminated the use of Quaaludes in the summer of 1980. Respondent's medical records concerning Mrs. Moore reflect that he did not examine her during the period May 9, 1979 and October 1, 1979, but continued to issue prescriptions to her for Demerol and Quaalude. Between December 1976 to June 1979, Respondent prescribed for Mrs. Moore in excess of 1400 cc. of injectable Demerol, 50 mm./cc., and 1900 tablets of 300 mg. Qualudes. Between July 1979 through December 1979, he prescribed 400 tablets of Quaalude,300 mg., 277 cc. of Demerol 50 mg./cc., and 230 cc. of Demerol, 100 mg./cc. Between July and November 1980, Respondent prescribed 101 cc. of Demerol, 50 mg./cc., 46 cc of Demerol 100 mg./cc., and 172 cc. of Demerol, 75 mg./cc. (Testimony of Dodd, Deatsch, Respondent, Moore, Petitioner's Exhibits 3-4, 8, Respondent's Exhibit 2) In the opinion of physicians who are experts in the field of drug treatment and internal medicine who reviewed the medical records of Gerald Cooney, Annette Groover, and Peggy Moore, Respondent exercised poor judgment in prescribing known addictive medicine in excessive amounts for prolonged periods to those patients, without properly monitoring their course of treatment. They therefore are of the opinion that Respondent failed to treat those patients in conformity with recognized acceptable standards of medical practice. Specifically, they based their opinions in the case of Cooney upon the fact that Respondent was aware of the patient's addiction to Dilaudid, yet prescribed inordinate amounts of the drug over an extended period of time without taking definitive action to either cut off the patient's supply or to change the medication. A normal dose of Dilaudid would be from four to six 4 mg. tablets a day and never should exceed 12 or 14 during limited time periods for acute pain. Respondent's dosage of 16 to 20 tablets per day on a continuing basis resulted in perpetuation of the patient's addiction. As to Annette Groover's case, the expert testimony reflects the opinion that since the Respondent was aware of the patient's former dependency upon Talwin, he should have prescribed other addictive drugs, such as Demerol, in limited amounts and attempt to use non-addictive medication for the patient's migraine headaches, particularly where, as here, they result from periods of tension. They also are of the opinion that the use of Demerol by the patient reflects a pattern of abuse, but not necessarily addiction. Further, a patient with a history of drug abuse should not have been permitted to administer Demerol by injection at her home, but should have been required to have such treatment administered by a nurse or at a hospital emergency room. The basis of the expert opinion in the case of Peggy Moore is that Respondent prescribed excessive amounts of Demerol and Quaalude for the patient without adequate monitoring of the need for such drugs, and that he permitted home administration rather than at his office, or a hospital site in spite of his expressed concern over the possibility that the patient may have been abusing the use of such drugs. The above opinions are confirmed by the evidence and accepted as a basis for this finding of fact. Other opinions expressed by the expert witnesses during the course of their testimony are not considered to be supported by the evidence. (Testimony of Deatsch, Davenport) Dr. John Smythe, a Winter Haven physician who has known the Respondent for a period of 27 years, is of the opinion that although Respondent's treatment of the patients in question was perhaps "unorthodox," he was dealing with severe chronic patients and perhaps showed too much compassion in prescribing greater drug amounts than he (Smythe) might have prescribed under similar circumstances. Respondent's reputation in the Winter Haven medical community is that of an intelligent, sincere, and conscientious physician who does not hesitate to refer patients to specialists as necessary. (Testimony of Smythe) Dr. William T. Steele, a Winter Haven physician who has known Respondent since the latter has practiced in Winter Haven, is of the opinion that he is an outstanding physician with high moral character who conducts his practice as well as any physician in the community. (Testimony of Steele)
Recommendation That Petitioner suspend Respondent's privilege to prescribe Schedule II controlled substances as defined by Chapter 893, Florida Statutes, for a period of one year, but that the suspension be stayed and Respondent be placed on probation for a like period under appropriate terms and supervision established by the Board to protect the public against inappropriate prescribing of controlled substances. DONE and ENTERED this 13th day of March, 1981, in Tallahassee, Florida. THOMAS C. OLDHAM Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 13th day of March, 1981. COPIES FURNISHED: Deborah J. Miller, Esquire Assistant General Counsel Department of Professional Regulation Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301 Robert A. Pyle, Esquire Post Office Box 557 Lake Alfred, Florida 33850
Findings Of Fact At all times material hereto Respondent has been licensed as a pharmacist having been issued license number 0015784. Respondent's license was previously suspended for a period of five (5) years by Final Order of the Florida Board of Pharmacy on June 15, 1984 in Case Number 0036893. In that prior case Respondent admitted to self medicating herself with controlled substances in violation of Section 465.016(1)(d)2, Florida Statutes. Respondent's license is therefore currently under suspension and has been suspended since June 15, 1984. Respondent was hospitalized at Shands Teaching Hospital in June, 1984 by George W. Sypert, M.D., for back and chest pains resulting from an automobile accident in May, 1983. This was Respondent's second hospitalization for treatment resulting from the accident. While hospitalized Dr. Sypert performed surgery on Respondent who was also attended by J. Marc Simard, M.D., a resident at the time. It was Dr. Simard who prepared the discharge summary on Respondent on June 19, 1984 and also wrote a discharge prescription for 10 Percodan which were to be taken one every six hours for severe pain remaining from the surgery which Dr. Sypert had performed. Both Respondent and her husband, George W. Bowen, were under the belief that Respondent would be "adequately medicated" for pain after her operation and upon her discharge. Mr. Bowen was formerly a licensed pharmacist in Florida, but his license has been revoked due to violations involving controlled substances. Mr. Bowen was extremely frustrated and concerned about the pain his wife was suffering and did not feel that 10 Percodan would be sufficient for her discharge. The Percodan prescription was given to Mr. Bowen who admitted during his testimony that he altered the prescription by adding a zero so that the prescription was then for 100 Percodan. Respondent never saw the prescription before or after it was altered, and her husband did not tell her what he had done. Mr. Bowen took this action out of concern for his wife and the pain she was suffering, and he did not take any of the Percodan himself. He had attempted to contact Dr. Sypert to request an increase in the prescription when he saw that Dr. Simard had written it for only 10 Percodan, but he was unsuccessful. Mr. Bowen presented the altered prescription at Eckerd's Drugs on June 20, 1984 and Russell Blaser, a licensed pharmacist, filled the prescription with 100 Percodan, which was paid for by Mr. Bowen and given to Mr. Bowen. Respondent was with her husband when he filled the prescription, but was almost immobile, having just been discharged. Blaser called Dr. Simard after he had filled the prescription to advise Dr. Simard that, due to Respondent's previous drug dependency, he felt that any further prescriptions should be for a lesser amount. It was at this time that Dr. Simard said the prescription he had written was for only 10 Percodan, not 100. Respondent was arrested on or about June 22, 1984, for obtaining a controlled substance by fraud. Following the arrest she learned for the first time that her husband had altered the prescription, and she thereupon destroyed the remaining Percodan.
Recommendation Based upon the foregoing, it is recommended that the Board of Pharmacy issue a Final Order dismissing these charges against Respondent. DONE and ENTERED this 5th day of November, 1985, at Tallahassee, Florida. DONALD D. CONN, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 5th day of November, 1985.' APPENDIX Adopted in Finding of Fact 1. Rejected in Findings of Fact 3 and 4. Adopted in Findings of Fact 2 and 6. Rejected in Findings of Fact 3, 4 and 7. Rejected as a conclusion of law which is not based on evidence in the record. COPIES FURNISHED: Rod Presnell, Executive Director Board of Pharmacy Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Bruce D. Lamb, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Deborah S. Bowen 1033 N.E. 8th Avenue Gainesville, Florida 32601 Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Salvatore A. Carpino, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
Findings Of Fact Alexander G. Toth graduated from medical school in 1943 and migrated to Miami in 1948. He took his three-year residency in general surgery at the V. A. Hospital in Miami starting in 1951 and thereafter practiced general surgery until 1976 when he had a serious accident. This accident plus additional health problems caused him to give up surgery and he has practiced family medicine since 1976. His office hours have been limited from 9 until 12 each week day since 1976. Approximately 10 patients per day were seen by Respondent during the period involved in these charges. At all times here relevant Respondent was licensed by Petitioner as a physician. Richard Hatcher was a patient of Respondent in 1975 at which time he complained of headaches and low back pain. Respondent prescribed Percodan, Doriden, Dilaudid and Placidyl during a one-year period Hatcher was a regular patient. At this time Hatcher had a suit pending to recover damages for injuries received in an automobile collision. Hatcher did not see Respondent with any regularity again until 1978. Respondent's patient records of Hatcher (Exhibit 5) show he treated Hatcher on 11-20-78 on complaint of can't sleep, low back pain and spasm of lower back, by prescribing 100 Valium and 100 Percodan. Exhibit 6, which is a copy of prescriptions written by Respondent for Hatcher, shows the following prescriptions were written for Hatcher on dates indicated: 6/2/78 - 30 Valium 10 mg; 8/8/78 - 50 Seconal and 30 Fastin 30 mg; 10/11/78 60 Tuinal 3 grs, 60 Fastin 30 mg, 50 Valium 10 mg and 100 Percodan; and 11/20/78 - Valium 10 mg, 30 Fastin 30 mg and 100 Percodan. Exhibit 5 shows in 1975 Hatcher was 6 feet and 180 pounds. The entry dated 12/18/78 opposite Fastin is (Wt 205). During the period 12/18/78 to 2/27/79 Respondent prescribed for Hatcher on numerous prescriptions the following: 300 Percodan, 250 Valium, 230 Tuinal 3 gr, 60 Fastin, 60 Demerol 100 mg, one 30 cc vial Demerol 100 mg per cc, and 30 syringes (Exhibit 6) . Exhibit 5 contains an entry dated 3/2/79 "(Wants Demerol) Refused - refer to JMH", and a final entry (3-19) Deceased." Hatcher voiced the same or similar complaints of pain on each visit to Respondent. Richard Hatcher was found dead in his apartment on or about 21 March 1979 some 24 to 36 hours after he died. Cause of death was acute intravenous narcotism. The syringe with which the fatal narcotic was injected was still in his arm when his body was found. Due to the rapid clearing of many drugs from the blood the autopsy failed to reveal which of the opiate drugs caused Hatcher's death. About one week later Mrs. Hatcher, the mother of Richard, received from her ex-husband and father of Richard a page from a notebook found in Richard's apartment after his death signed by Richard which indicates some concern by Hatcher that he might overdose on drugs given him by Dr. Toth, the Respondent (Exhibit 12). Richard Hatcher became seriously involved with drugs in 1967 when he was 21 years old. By 1975 his mother noted a personality change where he would quickly go from normal to extremely agitated. In the fall of 1978 Hatcher committed himself to Village South, a drug rehabilitation program in Dade County, for some 4 or 5 months. After release from Village South Hatcher continued to take drugs. To his mother's knowledge he overdosed several times before his death. Three times she found him unconscious on the floor of her apartment and on numerous other occasions he was "spaced out". Respondent testified that Hatcher showed no indication he had abused or misused the medications Respondent prescribed. If so, it is evident that Respondent did not closely observe Hatcher or do more than hear his litany of pain. On the other hand, Exhibit 5 shows that some 2-1/2 weeks before Hatcher's death Respondent refused to prescribe the Demerol wanted by Hatcher. Unless Respondent recognized the seriousness of Hatcher's addiction it is not conceivable that he would suddenly refuse drugs so freely prescribed in the past. Michael Kavney was a patient of Respondent from June 1979 until his death from an overdose of Placidyl on 14 or 15 January 1980. On June 11 1979 Kavney complained of pain in his shoulder and Respondent prescribed 50 Tylenol. Kavney was 6 feet tall, weighed 189 pounds, and told Respondent he wanted to lose weight. Respondent on June 11, 1979 also prescribed 50 Fastin. On 8-16-79 Respondent, at Kavney's request, called in a prescription for 50 Valium. On 9/7/79 he called in a prescription for 50 Tylenol. Both of these prescriptions resulted from a phone call to Respondent. On October 29, 1979 Kavney visited Respondent, told him the shoulder pain persists and he would like some more weight reducers. By this time Kavney's weight was down to 185 pounds from 189 four months earlier. Respondent prescribed 50 Tylenol, 50 Valium (Exhibit 4) and 30 Fastin (Exhibit 3). By script dated 11/21/79 Respondent prescribed 50 Fastin for Kavney and by script dated 11/26/79 he prescribed 50 Tylenol (Exhibit 4). No record of these is contained in Exhibit 3. By entry on Exhibit 3 dated December 17, 1979 Respondent recorded "pain left shoulder, using heat at home, can't take codeine, Percodan 50". The Tylenol, which had been prescribed on four previous occasions, contains 1 grain of codeine per tablet. On January 14, 1980 Kavney visited Respondent, told him of disturbed sleep patterns, that he had taken Placidyl on prior occasions with good results and Respondent prescribed 60 Placidyl (750). Kavney was found dead in his automobile with an empty bottle with Placidyl label on the floor. An autopsy done on January 15, 1980 shows Kavney died from an overdose of Placidyl. Terry McGarey grew up in Miami and played in bands with Kavney as early as high school days. He had also known Hatcher since 1963. McGarey first visited Respondent in 1970 with an arm injury. He next saw Respondent near the end of 1976 and he complained of headache and leg pains from an earlier motorcycle accident. McGarey received a prescription for Percodan. McGarey, who appeared as a witness, testified that he had visited Respondent every three or four weeks in 1976 complaining of headache and during these visits he also received Placidyl, Demerol, Parest and Valium. These visits continued in 1977 with the same frequency and results. Respondent's patient records for Terrance McGarey (Exhibit 1) commence 3/28/78. The first entry is not dated but states "cc severe headaches - nausea - at JMH March `78. Neuological dept. - treated for organic brain syndrome - at JMH 1976 migraine - no allergies - only relief Demerol. Rx demerol 100 mg #5 fiorinal tabs." Thereafter Exhibit 1 shows entries 7-31-78, 8-7-78, 8-28, 9-1, 9-6, 9-11, 9-27, 10-9, 10-20, 10-29, 10-31, 11-16, 11-22, 12-18, 12-22, 12-29, 1-3, 1-8, 3-21 and 4-19-79. Most of these entries resulted from office visits but some entries recorded prescriptions as a result of phone calls. During this period prescriptions were issued to McGarey for Percodan, Emperin, Doriden Parest, Tuinal, Demerol, Placidyl, Dalmane, Darvon, Seconal and Valium (Exhibit 2) On May 7, 1979 McGarey called the Cardella Pharmacy saying he was Dr. Toth, gave the correct DEA number and authorized the delivery of 18 Placidyl 50 mg to patient Jerry McGaret. The pharmacist called the doctor's office, which was closed, and then issued the drugs to McGarey. A subsequent try was unsuccessful when the pharmacist was told by Respondent's office that this man was no longer a patient of Respondent. Respondent testified that he treated McGarey for migraine headaches, insomnia, nervousness, and low back pain. He found no evidence of abnormal conditions in his examination of McGarey. Through mid-October Respondent had no indication McGarey was in a methadone program or addicted and the drugs were continued with each visit or phone call. On December 29 Respondent learned from McGarey that he had been admitted to JMH for seizures and the resident recommended Seconal. On this basis Respondent prescribed Seconal but did not learn the cause of the seizures. On January 8, 1979 McGarey's mother called Respondent to advise that her son was a drug abuser and had been on a methadone program for 18 months. Following this entry is the notation "No more Rx's - back to JMH". Respondent's next entry on Exhibit 1 is "Called records at JMH patient admitted 2-9-79 - overdosed - discharged 2-14 Signed out - mother took him home." Although Respondent testified it never entered his mind that McGarey might be a drug abuser he also testified that the symptoms of narcotic addiction are agitation, nervousness, slurred speech and poor equilibrium. On the witness stand McGarey exhibited traits of nervousness and agitation. He appeared hyperactive rather than calm and sedate. His movements were jerky rather than fluid and he did not give the impression of a normally relaxed person under tension because he was testifying. On 11 January 1980 Kirk Kratz, a 29-year-old male, visited Respondent's office as a patient. He had a cast on his right upper arm and stated it was fractured some two weeks earlier. Also he had received a gunshot wound in the abdomen before Christmas and a laparotomy had been performed. He complained of pain in the right arm. He was given a prescription for 100 Percodan for pain and 60 Tuinal 3 gr for sleep. Kratz returned 12 February with same complaints and was given prescriptions for 100 Percodan, 60 Tuinal and 30 Valium. On 2/29 Kraft appeared without the cast, told Respondent the police had broken the cast, held him in jail for 3 days and confiscated his medication. He was given prescriptions for 100 Percodan and 60 Tuinal. On 4/8/80 Kratz still complained of "pain in the shoulder and arm and can't sleep." Prescriptions for 100 Percodan, 60 Tuinal and 100 Valium were given him. Finally on 6/13, with complaint of pain in hand and shoulder, Kratz was given prescriptions for 100 Percodan and 30 Doriden (Exhibit 9). Hatcher and McGarey were drug addicts before and during the time they were being treated by Respondent. At one time or another both of them had been enrolled in the methadone program at Jackson Memorial Hospital and/or other withdrawal programs for addicts. In addition to getting drugs from Respondent, they were also obtaining drug prescriptions from other doctors. Also from the quantity of drugs prescribed for Kavney and Kratz it is evident that both of these individuals were also addicts. During the period between 1 January 1980 and 14 June 1980 Respondent, with an active practice of some 700 patients prescribed approximately 28,000 Percodan and 2,000 Percocet tablets to various patients. Exhibit 16 shows a breakdown of the 130 patients treated by Respondent during this period. While Exhibit 16 shows Kirk Kratz received 100 Percodan only on 2/29/80, Exhibit 8 indicates he received 500 Percodan between 1 January and 14 June 1980. Assuming all other entries on Exhibit 16 to be accurate, a spot check shows the following patients were given Percodan or Percocet during the period 1 January - 14 June in the following quantities: Steven Arnold - 300; Cathy Blauk - 450; Bill Davis - 500; Kirk Decker - 300; George Fernandez - 300; Sidney Ford - 600; Ron Jangie - 300; Jerome Johnson - 300; Patty La Fortuna - 310; Vincent La Fortuna - 200; William Leonard - 350; Mary Leslie - 300; Gus Melquezo - 400; Michael Pravioski - 225; Debbie Saey - 250; Robert Sandifer - 400; James Setters - 300; Alvin Terrell - 300; Mike Thill - 300; Mark Wolfson - 200; Joe Worth - 300; and Harvey Zemaster - 200. Exhibit 16 also shows that most of these prescriptions were written for quantities of 100. It also lists almost 18,000 Percodan issued to 130 patients during this period, or an average of 140 per patient. Percodan, Tuinal, Parest, Demerol and Seconal are Class II drugs. One hundred Percodan taken in a one-month period will cause addiction in the taker. After 48 hours taking Percodan every 4 to 6 hours the patient will have withdrawal symptoms. Although Placidyl, Valium, Doriden, Empirin and Dalmane are not Class II drugs, they are dangerous and therefore controlled. Fifteen Placidyls taken at one time can be fatal. Many of the drugs prescribed by Respondent, when taken in combination, create a synergistic effect which makes the combination greater than the sum of its parts. Similarly a synergistic effect is created when some of these drugs are taken in conjunction with alcohol. Fastin is used for weight control. Neither Hatcher nor Kavney at 6 feet and 180 - 185 pounds should have been a candidate for weight loss. Further, prescriptions for Fastin and Seconal (for sleep) at the same time are incompatible as one is an upper, the other a downer. Tuinal in combination with Valium will increase depression. When Fastin is added, a pharmacological jungle can result. Respondent acknowledged that he relied more on the statements of his patients than upon an examination to determine when to prescribe medications. If the patient said he hurt, Respondent would prescribe a pain killer. A two- week-old fracture properly set and in a cast should cause little pain. If pain persists two weeks after casting something is wrong that will not likely heal itself. Therefore, painkillers to mask the symptoms are contraindicated. Similarly, a persistent pain in the shoulder is likely to be caused by inflammation and an anti-flammatory agent is indicated. Neither Tylenol nor Percodan are anti-inflammatory agents. Dr. John V. Handwerker, M.D. was accepted as an expert in family practice medicine. After reviewing Respondent's records of Hatcher, Kavney, Kratz and McGarey he expressed the strong opinion that the complaints of the patients did not justify the narcotics prescribed; that much larger quantities of each drug were prescribed at one time than was medically indicated or prudent; that drugs were prescribed in dangerous combinations due to the synergistic effect if taken together, plus some of these drugs such as Fastin and Valium are mutually exclusive; that issuing a prescription to take these drugs "as needed" was improper and dangerous; and that narcotics were frequently prescribed for alleged ailments for which more effective non-narcotic drugs were available. This witness was particularly critical of the prescription for liquid Demerol, as this should be prescribed only when the patient can't take the drug orally. After reviewing Exhibit 7 Dr. Handwerker expressed the opinion that prescribing 28,000 Percodan tablets during a 5-1/2 month period could only be justified with a large practice limited to trauma patients and that the records and prescription schedules show a practice harmful to the public. This opinion was based partially on Dr. Handwerker's practice in which, during the same period, he saw 2,081 patients and wrote 73 prescriptions for 1,996 Percodan tablets. Exhibit 7 contains 291 prescriptions issued by Respondent during this period, and recovered by Petitioner's investigator from pharmacies in the vicinity of Respondent's office. These coupled with Respondent's patient records show some 28,000 Percodan and 2000 Percocet tablets were prescribed. Valium is the most commonly prescribed drug in the United States and one of the most abused drugs. If a patient is emotionally stable 60 Valium is too many to prescribe for a patient at one time. If a patient is emotionally disturbed there is even greater reason for not prescribing 60 Valium. Dr. Roderick Palmer, M.D., testified as an expert in clinical pharmacology. He opined that prescribing 100 Percodan for a patient at one time was not appropriate because if the pain results from a traumatic injury, such injury will normally cease being painful in 4 or 5 days, and 100 Percodan is enough to commit suicide or become addicted. Dr. Palmer described Percodan and Placidyl as widely abused drugs. Sixty Placidyl in one prescription is too many because of suicide potential. Further, if one Placidyl is taken every day for 60 days the patient would probably become addicted. Taking more than one Placidyl per day could impair coordination enough to result in an industrial or automobile accident or other injury. With respect to Exhibit 7, Dr. Palmer cited instructions for Percodan or Percocet that the physician should not prescribe enough to result in addiction (not more than 30) nor prescribe enough for patient to commit suicide. It is necessary for patients to return to the physician before the patient can become addicted to the drugs prescribed. In this way the doctor will not lose control over the patient which could result in the patient becoming addicted. With respect to the 28,000 Percodan prescribed in a 5-1/2 months period Dr. Palmer viewed that quantity as more than he would prescribe in a lifetime. Dr. Murray Sims, M.D., is a Board certified surgeon who testified on behalf of Respondent. He found the prescriptions issued to Hatcher, Kavney, McGarey and Kratz to be proper for the complaints of the patients. Sims has known Respondent for many years, and has worked, studied, and taken examinations with Respondent. Dr. Sims prescribes Percodan in quantities of 100 and even 200. He does not believe 100 Percodan taken in a 30-day period is addictive. He has one 93-year old patient to whom he mails prescriptions for 100 Percodan per month (40 to 60 days) because, as she told him, "It makes my day start off right." (Tr. Vol. II, p. 102). When asked if Percodan and Tuinal taken together would have a synergistic effect Dr. Sims said no (Tr. Vol. II, p. 67) but on p. 119 he testified "I guess it would, you get a relief of both, yes. Don't hold me too much about pharmacy." Dr. Sims practice is 99 percent devoted to surgery patients and if he has a patient with a non-surgical related disorder he usually refers the patient to another doctor. This witness's testimony regarding the various drugs prescribed by Respondent and the appropriateness thereof was not deemed as credible as was the testimony of Drs. Hardwerker and Palmer. This was so because the latter had more expertise in this area of medicine and demonstrated greater credibility on the witness stand.
The Issue Whether disciplinary action should be taken against the license of the Respondent, Roger Allen Bowers, to practice pharmacy in, the State of Florida.
Findings Of Fact The Respondent, Roger Allen Bowers, a registered pharmacist in the State of Florida, practiced pharmacy and was the manager of the prescription department at Scotty Discount Drugs at 3620 Blanding Boulevard in Jacksonville, Florida, during the period of time from May 1, 1978, to February 10, 1979. On February 28, 1979, a Complaint and Notice to Show Cause was issued by the Petitioner Board charging Respondent with violation of Sections 465.101(1)(e) and 893.07, Florida Statutes, for permitting improper maintenance of records in that he failed to keep "on a current basis a complete and accurate record of each controlled substance, controlled by Chapter 893, Florida Statutes," at said community pharmacy. Respondent Bowers requested an administrative hearing. Mary Haddad, a pharmacist licensed in the State of Florida and employed at Scotty Discount Drugs during January, February and March of 1979, noticed that large quantities of Percocet-5 were being ordered by Respondent Bowers. Ms. Haddad felt such an order was unusual, inasmuch as she did not fill any prescriptions for this medication during her first month of employment. She checked the pharmacy Schedule II files for a one-month period and found approximately three (3) prescriptions for Percocet-5 during that period. She noticed, however, that numerous narcotic forms were signed by Respondent reordering this medication. Ms. Haddad noted on February 9, 1979, that there was one 500 stock bottle of Percocet-5 on the shelf which was about three- quarters full. She reported her findings to Owen Scott, a supervisor for Scotty Discount Drugs. Mr. Scott considered the communication from Ms. Haddad and called David Hodge, an agent for Petitioner Board, and requested an immediate audit of the pharmacy. After Mr. Hodge's report was filed with Mr. Owen, Mr. Owen terminated Respondent from the employ of Scotty Discount Drugs. David L. Hodge, the inspector-investigator for the Petitioner Board, audited the pharmacy for a period of approximately nine (9) months previous to February, 1979. The audit showed that during the said nine (9) months' period there was a shortage of 17,628 Percocet-5 tablets, 4,097 Percodan tablets, 609 Dilaudid 4 mg. tablets, and 610 Dilaudid 2 mg. tablets. The audit was introduced into evidence without objection. Mr. Hodge made copies of all the order forms for the said nine (9) months' period at Lawrence Pharmaceuticals which had been sent to said firm and were signed by Respondent Bowers. These copies were introduced into evidence without objection. The Respondent properly filled out the forms, signed them, and properly filed the forms on which the narcotics were ordered. He properly filed the prescriptions that were filled. No explanation was given for the discrepancy between the large amount of narcotics ordered by Respondent as the manager of the pharmacy and the small number of prescriptions filled for these narcotics and the absence of these narcotics in the pharmacy at the time of the audit by Mr. Hodge. There were seven (7) licensed pharmacists employed by the pharmacy managed by Respondent. The store in which the pharmacy was located remained locked until unlocked by an employee, and the pharmacy remained locked. Several people had keys to the store, and the licensed pharmacists had keys to the pharmacy. There was a spare key to the pharmacy within the store in the store manager's office under a ledge by a small door next to the pharmacy. The assistant manager of the store, an unlicensed person, knew the location of this key, as perhaps did other people, inasmuch as it was left on the ledge when not in use. Petitioner submitted proposed findings of fact, memoranda of law and proposed recommended orders. These instruments were considered in the writing of this Order. To the extent the proposed findings of fact have not been adopted in, or are inconsistent with, factual findings in this Order they have been specifically rejected as being irrelevant or not having been supported by the evidence.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, the Hearing Officer recommends that the license of the Respondent, Roger Allen Bowers, be revoked. DONE and ORDERED this 12th day of October, 1979, in Tallahassee, Leon County, Florida. COPIES FURNISHED: Michael I. Schwartz, Esquire Suite 201, Ellis Building 1311 Executive Center Drive Tallahassee, Florida 32301 William J. Sheppard, Esquire 215 Washington Street Jacksonville, Florida 32202 DELPHENE C. STRICKLAND Hearing Officer Division of Administrative Hearings Room 101, Collins Building Tallahassee, Florida 32301 (904) 488-9675
