Findings Of Fact At all times material hereto, Respondent has been a medical doctor having been issued license number 0029773 by the State of Florida. At all times material hereto, Respondent was an employee of the Atlantic Stress and Obesity Clinic, Inc., located in North Miami Beach, Florida. While employed there, Respondent treated Daniel Wolfenstein, Cindy Vegazo, Neal Schoenberg, James F. McDonald, Scott Brown and Virginia Hagerty at the Clinic. On or about October 9, 1981, Respondent prescribed 45 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 893, Florida Statutes, for Daniel Wolfenstein. Respondent did not prescribe the above-described controlled substance to Daniel Wolfenstein for a medically justifiable purpose. That prescription was inappropriate and in an excessive or inappropriate quantity. Between the dates of approximately March 10, 1981, and February 8, 1982, Respondent prescribed 405 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 893, Florida Statutes, for Cindy Vegazo. Respondent did not prescribe the above-described controlled substance to Cindy Vegazo for a medically justifiable purpose. Those prescriptions were inappropriate and in excessive or inappropriate quantities. Between the dates of approximately October 9, 1981, and January 5, 1952, Respondent prescribed 90 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 593, Florida Statutes, for Neal Schoenberg. Respondent did not prescribe the above-described controlled substance to Neal Schoenberg for a medically justifiable purpose. Those prescriptions were inappropriate and in excessive or inappropriate quantities. Between the dates of approximately September 9, 1981, and January 22, 1952, Respondent prescribed 225 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 593, Florida Statutes, for James F. McDonald. Respondent did not prescribe the above-described controlled substance to James F. McDonald for a medically justifiable purpose. Those prescriptions were inappropriate and in excessive or inappropriate quantities. On or about October 13, 1981, Respondent prescribed 45 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 593, Florida Statutes, for Scott Brown. Respondent did not prescribe the above-described controlled substance to Scott Brown for a medically justifiable purpose. Said prescription was inappropriate and in excessive or inappropriate quantity. Between the dates of approximately August 4, 1981, and December 29, 1981, Respondent prescribed 135 methaqualone tablets 300 mg., a scheduled controlled substance pursuant to Chapter 893, Florida Statutes, for Virginia Hagerty. Respondent did not prescribe the above-described controlled substance to Virginia Hagerty for a medically justifiable purpose. Said prescriptions were inappropriate and in excessive or inappropriate quantities. The medical records of each of the above-listed patients indicate that each patient was given a prescription for 45 methaqualone tablets each time that patient came to the Atlantic Stress and Obesity Clinic to see Respondent. All patients indicated on the form checklist given to them at the Clinic that they were seeking medical aid because they were depressed, tense, unable to sleep, and/or without ambition. The progress notes for each patient are identical to the notes from prior visits, all progress notes appear in two different handwritings, and all patients are diagnosed as suffering from anxiety and insomnia, thereby requiring 45 more methaqualone tablets. There appears no variation in dosage or in diagnosis. Methaqualone is a depressant, and, therefore, prescribing methaqualone to depressed patients is contraindicted.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding Respondent guilty of Counts I through XIX of the Administrative Complaint and permanently revoking Respondent's license to practice medicine in the State of Florida. DONE and RECOMMENDED this 27th day of July, 1983, in Tallahassee, Leon County, Florida. LINDA M. RIGOT, 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 27th day of July, 1983. COPIES FURNISHED: Charlie L. Adams, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Adolfo Z. Aguila, Esquire Midway Professional Building 55 Grand Canal Drive, Suite 404 Miami, Florida 33144 Frederick Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Dorothy J. Faircloth, Executive Director Board of Medical Examiners 130 North Monroe Street Tallahassee, Florida 32301
Findings Of Fact The Petitioner is the Department of Professional Regulation, Board of Pharmacy. Petitioner seeks to suspend, revoke or take other disciplinary action against the Respondents. Respondent BGJM, Inc. (hereinafter "Save-on Drugs") holds Permit No. 7171 located at 4282 North State Road 7, Lauderdale Lakes, Florida. Save on Drugs has held said permit at all times material hereto. Respondent Robert E. Levy holds Pharmacy License No. 0017283 and has held said license at all times material hereto. Respondent Levy operated Save on Drugs as the sole proprietor and is the only pharmacist employed at the aforementioned store. Respondent Levy, while working at Save on Drugs, between the dates October 16, 1981 and April 2, 1982, dispensed approximately 139,000 Methaqualone tablets on 3,136 prescriptions. Respondent Levy ceased dispensing Methaqualone tablets approximately three (3) weeks prior to the institution of Petitioner's investigation of Respondent Levy's dispensing of controlled substances. The Respondent dispensed, over a three-month period, some 57,250 units of Methaqualone on behalf of one practitioner, a Dr. Lena. A specific breakdown of Dr. Lena's prescribing activity for part of the relevant period is as follows: DATE PHARMACY DRUG AMOUNT SCRIPT 12/14/81 Save-On Quaa-300 mg. 630 14 12/15 Save-On 720 16 12/16 Save-On 495 11 12/17 Save-On 765 17 12/18 Save-On 1,440 32 12/21 Save-On 945 21 12/22 Save-On 1 x 30 mg. 675 15 12/23 Save-On incl. 1,080 24 12/24 Save-On 1,215 27 12/28 Save-On 1,035 23 12/29 Save-On 1,305 29 12/30 Save-On 1,575 35 12/31 Save-On 1,305 29 Totals 13,185 293 The numerous prescriptions introduced into evidence by the Petitioner reflect circumstances where Respondent Levy failed to properly initial and date Schedule II prescriptions as they were filed. As example, Petitioner offered the following: prescription Nos. 48854, 48052, 50189, 48068, 48856, 48912 and 48905. Louis Fisher 2/ , an employee of the Department of Justice, Drug Enforcement Administration, since approximately November, 1971, has been involved with the regulation of controlled substances. Mr. Fisher works with doctors as well as pharmacists at the retail level. Mr. Fisher is a registered pharmacist and has been charged with drafting regulations for controlled substances. Without question, Methaqualone is a Schedule II drug and is a sedative and hypnotic agent. The drug has a high abuse potential. During the summer of 1982, Methaqualone was changed from Schedule II to a Schedule I controlled substance. After being provided with a hypothetical situation giving the number of prescriptions that Respondent Levy had filled during the time period involved, Mr. Fisher concluded that a pharmacist filling the number of prescriptions within the time period as is here involved by Respondent Levy was, in Mr. Fisher's opinion, unprofessional, excessive, outside the course of good professional practices, and not conduct amounting to professional practice in the patients' best interest. 3/ Dr. Lena was employed by Northeast Medical Services, a stress clinic. In this regard, the parties stipulated that all the prescriptions involved herein were written by a licensed medical doctor. Daniel O'Connell, an investigator with the Department of Professional Regulation, visited the Respondent's store during approximately October 1981, and performed a routine change of ownership inspection. At that time, Respondent Levy engaged in a conversation with investigator O'Connell at which time Respondent Levy was apprised of the problem with respect to dispensing Methaqualone in the south Florida area. Jim R. Golden, an investigator with the Department of Professional Regulation since approximately September 1981, visited Respondent Levy's store during April 1982, to perform a routine inspection to determine the amount of Schedule II drug prescriptions that Respondent was filling. Investigator Golden reviewed a large number of prescriptions that were filled by Respondent for Dr. Lena and inquired of Respondent the reason for dispensing such a large number of prescriptions for Methaqualone tablets. Respondent Levy replied that it was the "money end of it" and that he (Respondent) could fill six (6) Methaqualone prescriptions and do better with those prescriptions from a profit viewpoint than he could with the remainder of his other prescribing activities in the store for the remainder of any given day. Further, Respondent related that he hand to do extensive repairs to make the store operational. (Testimony of Investigator Golden)
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED: That Respondent BGJM, Inc.'s Permit No.7171 be REVOKED. That Respondent Robert E. Levy's Pharmacy License No. 0017283 be placed on probation for a period of two (2) years. RECOMMENDED this 12th day of May, 1983, in Tallahassee, Florida. JAMES E. BRADWELL, 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 12th day of May, 1983.
The Issue The issue for consideration in this hearing is whether Respondent's license to practice osteopathic medicine in Florida should be disciplined because of the matters alleged in the Administrative Complaint filed herein.
Findings Of Fact At all times pertinent to the allegations herein, the Board of Osteopathic Medicine was the state agency in Florida responsible for the licensing of osteopathic physicians and for the regulation of the practice of osteopathic medicine in this state. By stipulation, the parties agreed that Respondent was, at all times material hereto, a licensed osteopathic physician in the State of Florida. On May 1, 1990, Patient #1, (R.C.) presented to the Respondent at his office in Orlando for treatment of obesity. At that time, the Respondent, who holds himself out as a specialist in and was determined to be an expert in the field of bariatric medicine, (weight control), had the weight, blood pressure and pulse rate of the patient taken, and other measurements made. At that time, the patient was 6'2" tall and weighed 196 pounds. His blood pressure was 124 over 76, and his pulse rate was 70. He had a waist measurement of 38 1/2" and a hip measurement of 40". As a part of the case history taken of the patient, it appeared that he had no significant matters to report except for the fact that he had periodic shortness of breath and members of his family had had both high blood pressure and heart trouble. There were no other contraindications to treatment. Respondent conducted an examination of the patient and determined that the patient had had liposuction in the stomach area and breasts approximately one year previously, and that he got little exercise, yet smoked 2 1/2 packs of cigarettes per day. He was a reformed alcoholic and felt he was in good general health. Respondent's evaluation of the patient at the time was that he appeared to look well. The medical records reflect the word, "CORPUL", which is an acronym for cardiac/pulmonary, and in connection therewith, Respondent noted that the patient's condition was "excellent." As a part of his initial work up, the Respondent drew blood from the patient which was forwarded to a laboratory for analysis, and he also did a cardiogram. Though the cardiogram appeared "grossly normal" there was some minor irregularity which the Respondent felt necessitated further evaluation. Therefore, the cardiogram was sent to a cardiologist, Dr. Arnold, for evaluation. The report of the cardiologist indicated that the cardiogram was essentially normal with a "PR" interval at the upper limit of normal. Before the report was returned by the cardiologist, Respondent prescribed certain medications for this patient. Because the patient had high sodium levels in his blood, the Respondent prescribed a diuretic. He also prescribed Thyroglobulin, a specialized form of thyroid medication to aid the patient's metabolism mildly and safely. In addition, he prescribed 30 mg of Obazine per day to be taken in the morning as an appetite supressant; potassium chloride for extra potassium; and Phentermine, another appetite supressant to be taken in the afternoon. For after supper medication, Respondent prescribed a medication for digestion and to increase bile flow, and a 1/2 gram of Phenobarbitol to relax the patient in order to reduce his habit of snacking, and provided a detoxifying agent for the liver. These were the only drugs prescribed at that time. Respondent also, however, instructed the patient that he must not have any further liposuction. In the opinion of Dr. Weiss, the Board's expert in the field of bariatric medicine, the use of the secretary to transcribe the Respondent's verbal comments regarding his patients into the record is not inappropriate. However, the use of the word, "CORPUL" followed by the word, "excellent" seems to fall somewhat below standard, in his opinion. In this case, an acceptable standard would be for the physician to put into the chart exactly the details of the evaluation, and the word, "excellent" does not say much. Notwithstanding the fact that records show the patient's pulse rate and blood pressure, they did not show that the Respondent palpated the patient's chest or listened to the heartbeat. Therefore, the use of the word, "excellent" in this case is below standard. Respondent's records also include the word, "dispense", followed by several medications which Respondent prescribed for the patient. There was no indication in the record why each of these medications was prescribed. Dr. Weiss concludes this is a deficiency in that the record does not show that the Respondent actually examined the patient before medicating him, even though Respondent indicated he had done so. In fact, the only comment as to the patient's general health is made by the secretary, not by a physician or a nurse. Further, though Respondent indicated at hearing that the patient suffered from emphysema, there is no indication anywhere in the notes that that condition existed. Dr. Weiss also noted that the Respondent prescribed medication for a thyroid condition but there appears, from the medical record kept by the Respondent, no reason to treat a thyroid condition. There is no indication that the patient demonstrated any of the clinical signs of hyperthyroidism. By the same token, a prescription for Phenobarbitol, to be taken in small quantities at the hour of sleep, is well within standards if proper indications for that use are noted. Here, according to Dr. Weiss, in Respondent's records there is no indication as to why the substance was dispensed. Respondent's testimony at hearing provides justification, and there is no challenge to the actual prescription, but the medical record is insufficient in that it fails to show the reason for the dispensing of any of the specific medications prescribed. The Respondent's next contact with his patient was by telephone on May 17, 1990 when the patient indicated that the blue Phenobarbitol tablet was making him feel like he was dying. According to the records, the patient was nervous, "hyped-up" and his chest was tight. The medical note entered by the secretary indicates that she had spoken with the Respondent about the patient and the Respondent said for the patient to take one-half capsule with food. If that worked, the patient could return to a full dose. According to Dr. Weiss, this is "far, far below the standard of care", especially when the patient was, as here, showing signs of cardiac problems in the sense of shortness of breath and tightness in the chest, A prudent physician, according to Dr. Weiss, would have stopped medication entirely, had the patient come to the office, or, if an emergency problem existed, told the patient to go to the hospital by ambulance. This is the case here, especially since the cardiogram report had not been received from the cardiologist. If the Respondent felt either inadequate to interpret the cardiogram or that the cardiogram showed some irregularity, he should not have recommended drugs to the patient, as he did here, which affected the heart. In that regard, Dr. Weiss opines, it is impossible to treat all patients within a standard template or protocol, as it appears Respondent did, since all patients are individuals. On May 14, 1990, the patient again telephoned Respondent's office requesting a list of all medications he was then taking. At that point, the patient indicated he was at a cardiologist's office, (Dr. Latif), and needed to know the name of the drugs he was taking. Respondent's secretary asked the patient if this were an emergency visit, and the patient indicated it was not. Because the patient would not volunteer any information or answer directly any of the questions of the secretary, she suggested that Respondent call him right back at the cardiologist's office and the patient agreed. However, before the Respondent could call back, the patient departed Dr. Latif's office, apparently having decided he could not afford the cardiologist's fee. The patient records reflect, in Respondent's handwriting, that the patient had told him he was at the cardiologist's because the cardiogram was borderline abnormal and he had been worrying about it since it was taken. Respondent's notes on this matter reflect he assured the patient that the cardiologist's report indicated there was no problem. The patient then indicated he felt fine and had gone to Dr. Latif only for a check up. Respondent contends he discussed with the patient his exercise regimen and advised him not to get overheated while on any of the medications he was taking. The entry relating to the May 29, 1990 visit reflects that the patient had lost approximately 10 pounds and his blood pressure was down but his pulse rate was up somewhat. The note indicates that the patient "feels fine and is happy with the Obazine" which Respondent had prescribed for him. By observation, Respondent noted that the patient "looks well" and again, the notation "CORPUL excellent" in Respondent's hand, along with a change of some of the medications administered, is listed in the record with no reason being shown for either the change or the continuation. This is below standard. According to Dr. Weiss, the details rather than the conclusion should be reflected in the records. The next appointment with the patient was on June 29, 1990 when the records reflect the patient had lost weight and his blood pressure remained good, but there was no indication of what his pulse rate was. The records reflect certain changes at the restaurant where the patient was working interfered with his sleep; that he was winning at the dog track and planned to go to Las Vegas; but that he was hungry after exercising in the evening and asked for a stronger pill to take in the morning with breakfast. The patient indicated that the Esidrix 50 mg made his heart race. In response, according to the records in the Respondent's handwriting, Respondent reduced the strength of the Esidrix dose from 50 mg to 25 mg and changed the Phenobarbitol from blue to yellow. According to Dr. Weiss, the secretary's notes contain certain information but not all that is necessary. Weiss noted that the patient requested a stronger appetite supressant even though it is noted that the lighter dose made his heart race. A more prudent physician, in Dr. Weiss' opinion, practicing at the level of standard of care, would have discontinued any medication which made the patient's heart race and would have done a cardiogram or at least would have checked the patient's pulse. Here the record fails to reflect that the pulse rate was taken. If a doctor is made aware of that condition, he should look into it, and there is no indication, from the medical records, that this was done. According to Weiss, this is grossly incorrect. In fact, there is no indication that Respondent even examined the patient before making any change in his medictions, and that, in itself, would be a deviation from standard. Respondent indicates that if he made any entry on a patient's record in his own hand, it was done as a result of an examination of the patient. In this case, however, if respondent did examine the patient, he made no reference in the notes as to why he did what he did nor did he make any record of his rationale or reasoning. This is below standard. When the patient was informed that Respondent would not be able to keep the appointment scheduled for July 17, 1990, he indicated he had changed his schedule and needed a change in the times of taking and the strengths of his medications. When the patient did come in his blood pressure was taken along with his weight but there was no indication he pulse rate was measured, and the medical records in the Respondent's handwriting reveal certain changes to medications which do not show either details of the change or the reason therefor. Again, appetite supressants were dispensed, as was a tension reducer, without any physical examination being reflected in the records. The patient was again seen in the office by Respondent on August 22, 1990, and the records for this visit reflect not only the weight but also the blood pressure reading and the pulse rate. Respondent contends that the entry relating to the pulse is in his handwriting and made as a result of an examination, as is the word "excellent" following the note, "CORPUL" in that entry. According to Dr. Weiss, the secretary noted in the record, and it so appears, that the patient was having problems with his bowels. Nonetheless, the records show no details of any examination as a result of this complaint, notwithstanding Respondent's assertion at hearing that whenever he makes an entry in the record he has examined the patient. On October 1, 1990, even after the patient missed his September 20, 1990 appointment, the Respondent authorized his staff to mail a one month supply of prescription medications to the patient. According to Dr. Weiss, this is not within standards, and the medical record does not show why the drugs were mailed, nor does it say which medications were dispatched this way. Weiss contends one can assume it was the same regimen as previously prescribed, but in his opinion, it is inappropriate to do this in a metropolitan area, and to do so is well below the standard of care. This is so especially in light of the previous racing heart beat, the arrythmia and the patient's physical complaints. From Respondent's comment in the record, "this time only", it would appear Respondent recognized the riskiness of his actions, so Weiss believes. On October 29, 1990, the patient again came to Respondent's office and his weight, blood pressure and pulse rate were taken. The secretary noted no problems and that the patient looked well. Respondent noted in his own hand that the cardiac pulmonary condition was excellent and also noted that the patient might be getting a new restaurant. According to Dr. Weiss, this is meaningless to anyone other than the person who wrote it since there is nothing in the record which indicates what the entry means. When the patient came to the office on November 26, 1990, his weight and blood pressure were taken but there is no indication his pulse rate was measured nor is there any entry on the form for that date in the Respondent's hand. According to Dr. Weiss, the prescription for Xanax, which appears to be in the handwriting of the secretary, showed no indication that the patient was examined or, if he was, any clinical findings or clinical reason for the prescription. Again, on December 26, 1990, the patient was weighed and his blood pressure taken, but no pulse entry was made. Again, there appears to be no entry in the Respondent's hand, including the CORPUL description, which is left blank. From this, it is assumed the Respondent did not see the patient. R.C. missed his scheduled appointment on January 21, 1991, and when he appeared at Respondent's office on February 11, 1991, his blood pressure and his weight were noted, but there was no indication the Respondent saw the patient. In fact, the secretary's note indicates the Respondent approved a one month medication pickup but there is no entry in Respondent's hand. From this it would appear the medications were dispensed without the patient having seen the doctor, and in the opinion of Dr. Weiss, this is incorrect practice and below standard. When the patient came in on April 19, 1991, he was seen by the Respondent; his weight, blood pressure and pulse were taken, and at least one of his medications was changed. On this date, Respondent prescribed a tranquilizer, Tranxene. Again, the record fails to indicate any reason for the prescription of a tranquilizer, especially in light of the fact that the note in the secretary's hand indicates that the patient was in a rush but was feeling good and looked well. The record of the May 15, 1991 visit shows that the patient was weighed and his blood pressure taken, but there is no indication of his pulse rate. The secretary noted that the patient was upset because of his girlfriend's diagnosis of breast cancer. In the Respondent's hand, a notation reflects a prescription for Tranxene again as a result of the patient's nervous condition. According to Weiss, this is the type of entry that should be made routinely, but there is no reference in the record to the patient's cardiac pulmonary status which had been routinely commented upon previously. The records also reflect that on July 21, 1991, without seeing the patient, Respondent prescribed a refill on the Tranxene, and called it in to the pharmacy. At this time, the patient had requested a 60 pill prescription with provision for a refill, but the medical note reflects the Respondent said "No." At hearing, Respondent claimed that his use of the word "no" is indicative of his recognition that the patient had a drug personality. This does not necessarily follow, but in any event, Respondent properly refused to give the patient more than a reasonable dose, and a prescription of 36 Tranxene, as given here, is not below standard. On June 1, 1992, there is an indication that the weight, blood pressure and pulse were taken, and it appears the patient had, over a year, gained approximately 25 pounds, though his blood pressure remained about the same. At this point, the note in the secretary's hand reflects that the patient was starting a new job, was feeling fine physically, and was coming off a three month hiatus between jobs. In the Respondent's hand, however, is a reference to Phenobarbitol white and another drug, CH, which is not identified. According to Dr. Weiss, this was two years since a cardiogram or blood profile had been taken, and to continue to prescribe drugs of this nature without any intervening testing of blood or heart evaluation falls below the appropriate standard of care. In fact, the record does not reflect at this visit that the Respondent evaluated the patient's cardiac condition because his description of the CORPUL status does not appear in the record. On July 7, 1992, according to the records, a telephone call to Respondent's office from the medical examiner of Volusia County indicated R.C. had died on June 17, 1992, and requesting the Respondent's medical records. The autopsy report, dated July 31, 1992, reflects that the cause of death was acute drug intoxication, and Respondent contends that this is justification for his refusal to give the patient all the various medications he wanted. A review of the post mortem toxicology relating to drugs found in the patient's urine and blood at the time of death indicates, however, that none of the drugs which were being prescribed by Respondent were found in the deceased's body on autopsy. Respondent is a longstanding practitioner of osteopathic medicine having been in practice since August, 1954. When R.C. first came to see him, on May 1, 1990, the patient's history was taken and recorded on the history form. The patient was 34 years old and claimed to be in fair health. It appears that the patient had moderate emphysema, and at that point and continuing thereafter, Respondent claims, he tried to get the patient to quit smoking. He did not, however, enter this fact in the patient's records. All other signs, however, were normal, except for the patient's blood which showed elevated levels of lipid concentration and low iron. In short, the patient's triglycerides were elevated and his thyroid levels were moderately low. The patient's cardiogram showed a small abnormality in the computer evaluation which Respondent sent to a cardiologist, Dr. Arnold, for interpretation. After the initial visit, and after giving the patient his standard dietary instructions and policies, the Respondent prescribed the medications previously described. According to Respondent, his normal practice was for the nurse to write down what the patient said while weight was taken and blood pressure measured. Respondent usually took the pulse rate. The term, "excellent", used in conjunction with the word "CORPUL" in the records related to heart function, not to the emphysema. Respondent admits that "perhaps" he should have entered the emphysema in the record. Respondent claims he entered all information regarding changes in prescriptions, yet a review of the records clearly shows this is not the case. Many of the entries in the records, which appear to be in the nurse's handwriting, including such things as the patient's reaction to pills on May 7, 1990, was based on Respondent's conversations with the patient which he thereafter recounted to the nurse to be placed into the records. It would appear, however, that there is some confusion whether the entries other than those placed therein by the Respondent, were by a nurse or by a secretary. This was not clarified by the evidence of record. Respondent admits that he does not keep the detailed records he would keep if he were practicing in a hospital situation. He is of the opinion that he is the only one to whom his records need make sense. Because in this case the patient was a friend of his, his need to make further and more detailed patient notes was even less that it would be ordinarily. He was aware of what he considered to be the patient's drug tendency and did not put it in the patient's record because he did not feel that he wanted to subject a friend to this type of record even though he recognized that medical records are, for the most part, confidential. On several occasions, Respondent admitted it was an omission to fail to place a pulse reading in the record or to fail to make certain comments, but he reiterated time and again, that in his opinion his notes did not have to reflect in any detail reasons or rationale for what he did. He consistently took the position that he knew what he did; that he was the only one who looked at the records; and to him, that was sufficient. On July 29, 1991, medications were dispensed after a telephone conversation with the Patient. Respondent claims this was because he had had an argument with the patient over the number of pills which could be furnished; 36 Tranxene tables as opposed to the 60 tablets requested. Respondent admits he authorized the prescription even though he did not see the patient at that time, and in fact did not see the patient again for almost a year. On June 1, 1992, when he again saw the patient, he refused to treat the patient further without another cardiogram and blood work. Nonetheless, Respondent admits, and the records reflect, that on that particular occasion, he allowed the patient to receive his normal prescription for medications, with some modifications, and he admits that all of these medications dispensed are not listed in the patient record. Respondent also admits he does not, and did not, in this case, dispense medications in a child-proof container, as is required by statute and rule. He claims this was because the patient requested they not be placed in a child-proof container, and introduced an entry on the back of the envelope containing the patient's medical records, bearing what purports to be the patient's signature, which so indicates. Respondent also claims that in a discussion with the chairman of the Board of Pharmacy, he determined that use of a crush-proof box in lieu of a child-proof container for these medications, which are, admittedly, controlled substances, was appropriate. Respondent feels that his care of this patient was within standards and that his prescriptions were dispensed with proper medical justification. He contends that R.C. was a hard patient to deal with, being both compulsive and anal retentive. In treating this patient, Respondent claims he used a modified Weintraub protocol, an accepted guideline for the prescription of appetite suppressants and believes he prescribed appropriate medications in appropriate quantities. Respondent also believes he adequately examined the patient before he prescribed any medications for him and contends he always saw the patient before he allowed him to have any more drugs. This has been shown not to be the case. Respondent agrees that a medical record should justify the course of treatment rendered to a patient. Everything should be justified but not, he claims, in as great a detail as in a hospital setting. Respondent is of the opinion that his records are such that a subsequent treating physician could take them and determine what clinical treatment was rendered to the individual without speaking with the Respondent. In addition to the daily narrative record, Respondent contends that the prescriptions are maintained in the records and should be examined in conjunction with the narrative record. If done, this would show what drugs were prescribed and in what amounts. However, it would not show why the prescription was issued initially, and this information is also not adequately laid out in the narrative records. Respondent claims he writes his chart for himself and not for others. Respondent recognizes he did not note any emphysema in his medical records. He also did not enter any instructions he gave to the patient to quit smoking in the medical records. He did not discuss in the records, or with the patient right away, that the patient should continue to exercise. He admits the records do not show that he reviewed Dr. Arnold's report on the cardiogram but only that he received it, and he admits that the records do not show the patient was retaining fluid in the stomach. In that regard, Respondent had recommended metahydrine, a diuretic, for the patient but he contends the record reflecting the patient had had liposuction also reflects that the patient was retaining fluid, and he believed this was sufficient recognition of that fact. This does not necessarily follow, however. Respondent admits that even a bariatric specialist could have had trouble determining from his records that fluid was in the stomach rather than elsewhere in the body. Respondent's treatment of this patient was evaluated by Dr. Wilmer L. Asher, a specialist in bariatric medicine practicing in Colorado for more than thirty years. In the course of his evaluation, Dr. Asher, who has known Respondent as a bariatric physician through the American Society of Bariatric Physicians for approximately twenty-five years, had the opportunity to evaluate Dr. Weiss' written report, the medical records in this case, the investigative report and Dr. Arnold's cardiographic report. Based on his evaluation of the entire file, Dr. Asher concluded that Respondent provided the patient with an adequate initial work-up, more than that usually done. The use of an electrocardiogram on an individual who had no apparent cardiovascular complaints at the time of work-up was above and beyond the norm. He also concluded that the Respondent's prescription, dispensing and administering legend drugs to this patient was neither inappropriate nor in excessive nor inappropriate quantities. Dr. Asher further concluded that on the basis of the Respondent's initial work-up, the diagnosis of obesity was appropriate and the plan of treatment Respondent developed was appropriate for this patient. He concludes that the medical records kept by the Respondent for this patient justified the course of treatment. There is no mention in the record of risk, but, in Dr. Asher's opinion, the medical management of an obese patient by a prudent bariatrician as Respondent, in Asher's opinion, involved a negligible amount of risk. Bariatricians do not ordinarily discuss risks associated with medical management of obesity. Therefore, he contends, Respondent's failure to do so was not below standard. Based on his thirty years of bariatric practice, Dr. Asher was able to find no evidence of Respondent's failure to meet applicable standards of care in his examinations, his diagnosis and his treatment of this patient. In that regard it should be noted that Dr. Asher admitted he was not specifically familiar with Florida standards but concluded they would, in all probability, be consistent with the medical standards in other states with which he is familiar. On October 29, 1992, the Department conducted an inspection of the Respondent's office because of his license as a dispensing physician. At that time, there were several discrepancies noted, one of which was that the Respondent's license to dispense drugs had expired. Respondent admits that this is the case, and that during the period from January, 1992 through October, 1992, he was not registered as a dispensing physician. He claims that he was under the impression that the renewal was automatic, and when he found it was not and his certificate had expired, he immediately sent in the required fee and the application for recertification, which was granted. It is so found. There were, however, other discrepancies discovered during the October 29, 1992 inspection, and these included a failure to properly label medications for dispensing; the sign indicating the availability of generic substitutes was not properly posted; all controlled substance refills were not properly initialed and dated; controlled substance prescriptions were not being properly maintained and purchase records for controlled substances were not maintained and readily recoverable. A follow-up inspection was conducted on July 13, 1994, and all previously identified discrepancies had been corrected. The inspection was considered to be satisfactory. At the hearing, Petitioner offered no evidence of any prior disciplinary action having been taken against the Respondent by the Board or any other regulatory body. Subsequent to the hearing, however, Petitioner moved the introduction of a record of a previous disciplinary action by the Board, the admission of which Respondent strongly resists. A review of the pleading reveals that the record in issue was missed in the agency's prior search of its records because it was filed under a misspelled name. Examination of the document itself does not indicate the alleged misconduct upon which it is predicated. All that can be discerned from a review of the matter objected to is that in 1987 Respondent entered into a stipulated settlement of another Administrative Complaint filed by the Board and that as a result thereof, Respondent was fined $2,000, reprimanded and placed on probation for two years under conditions dictated by the Board. Evidentiary acceptance of this prior action is granted over Respondent's objection with the understanding that it will not be considered on the disputed issue of the Respondent's guilt or innocence of the matters alleged in the instant Complaint but will be considered only if and after a finding of guilt of any of the misconduct alleged herein has been made, and then only as a matter in aggravation of punishment.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is, therefore: RECOMMENDED that Respondent, Edwin Gettins, D.O. be found guilty of violating Sections 459.015(1)(x)(o)&(g), Florida Statutes, (other than utilizing an improper method of dispensing, for which he should be found not guilty); that he be reprimanded and ordered to pay an administrative fine of $4,000; and that his license to practice osteopathic medicine in Florida be placed on probation for two years under such terms and conditions as may be prescribed by the Board of Osteopathic Medicine. RECOMMENDED this 9th day of November, 1995, in Tallahassee, Florida. ARNOLD H. POLLOCK, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 9th day of November, 1995. APPENDIX TO RECOMMENDED ORDER IN CASE NO. 95-1834 The following constitutes my specific rulings pursuant to Section 120.59(2), Florida Statutes, on all of the Proposed Findings of Fact submitted by the parties to this case. FOR THE PETITIONER: 1. - 3. Accepted and incorporated herein. 4. & 5. Accepted and incorporated herein. - 8. Accepted and incorporated herein. Accepted. - 12. Accepted and incorporated herein. 13. & 14. Accepted and incorporated herein. 15. - 25. Accepted and incorporated herein. & 27. Accepted and incorporated herein. Accepted and incorporated herein. Accepted and incorporated herein. - 32. Accepted. 33. & 34. Accepted but characterization of records as 35. - 37. "deficient" borders on being a Conclusion of Law. Accepted and incorporated herein. 38. Accepted. 39. Accepted. 40. Accepted. 41. First sentence accepted and incorporated herein. Second sentence accepted. 42. Accepted. 43. - 45. Accepted and incorporated herein. 46. Accepted. 47. Accepted. 48. - 50. Accepted and incorporated herein. 51. Accepted. 52. Accepted. 53. - 56. Accepted and incorporated herein. 57. Accepted. 58. Accepted. 59. - 62. Accepted and incorporated herein. 63. Accepted. 64. Accepted. - 69. Accepted and incorporated herein. Accepted. Accepted. Accepted and incorporated herein. Accepted. Accepted and incorporated herein. Accepted. Accepted and incorporated herein. Accepted. - 84. Accepted and incorporated herein. Accepted. - 92. Accepted and incorporated herein. Accepted. - 97. Accepted and incorporated herein. 98. Accepted. 99. Accepted and incorporated herein. 100. Accepted. 101. Accepted and incorporated herein. 102. Accepted. 103. - 107. Accepted and incorporated herein. 108. - 110. Accepted. 111. Accepted and incorporated herein. 112. - 115. Accepted. FOR THE RESPONDENT: Accepted and incorporated herein. Accepted and incorporated herein. Rejected as not being an accurate statement of facts in all cases. Accepted. Rejected as contra to the weight of the evidence. Rejected as contra to the weight of the evidence. COPIES FURNISHED: Britt Thomas, Esquire Agency for health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0792 Wilson Jerry Foster, Esquire Suite 101-A 1342 Timberlane Road Tallahassee, Florida 32321-1775 Jerome W. Hoffman General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32309 William H. Buckhalt Executive Director Board of Osteopathic Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792
Findings Of Fact The Respondent, Solomon D. Klotz, M.D., at all times pertinent hereto, has held a current, valid medical license number ME 0002269, issued by the Board of Medical Examiners, Department of Professional Regulation, which is the agency charged with enforcing Chapter 458, the "Medical Practice Act," as it relates to qualification for licensure and standards for regulating medical practice of physicians licensed in the State of Florida. The Respondent is also board- certified by the American Board of Internal Medicine in internal medicine and is board- certified in the field of allergy and immunology by the American Board of Allergy and Immunology. The Respondent obtained his M.D. Degree from New York Medical College in 1937, obtaining a Masters from that institution in 1942. He was licensed in New York in 1938 and was made a diplomate of the National Board of Medical Examiners in 1938. He was issued his Florida license in 1941. He served in the Medical Corps of the United States Army in World War II and during the years 1945 and 1946 was a clinical instructor at New York Medical College, and a research fellow at Metropolitan Hospital Research Unit in New York. The Respondent has practiced in his specialty field of internal medicine as well as allergy and immunology in Florida for many years. He is presently a clinical professor at the College of Health of the University of Central Florida, and an adjunct professor at the Department of Biological Sciences at the University of Central Florida. Respondent is presently on the medical staffs at Winter Park Memorial Hospital, Florida Hospital, Orlando Regional Medical Center and Humana Hospital/Lucerne, with a senior consultant rating at each of the above hospitals. The Respondent is a member of 21 professional societies and was a founding member of the Salk Institute for Biological Studies and, the board of the Joint Council of Allergy and Immunology. He has served as president of the American College of Allergists, the Florida Allergy Society, Southeastern Allergy Society, and is president of the medical staff of Florida Hospital in Orlando. The Respondent has published or presented more than 50 research papers, seven of which have been published within the past three years in such journals as the Annals of Allergy, the Journal of the Florida Medical Association, the Journal of the American Academy of Allergy and Immunology and the American Heart Journal. Concerning the disease or condition most pertinent to the charges in the administrative complaint, the Respondent published a paper jointly with Dr. Von Hilsheimer in 1970 concerning minimal brain dysfunction, attention disorders and the diagnosis of functional narcolepsy. Dr. George Von Hilsheimer was accepted as Respondent's expert witness concerning the diagnosis of narcolepsy and the various forms or manifestations of narcolepsy and the treatment thereof. He is a licensed psychologist in the State of Florida, having been educated at the University of Miami with postgraduate work at the University of Chicago. He interned in psychology at the Corsack Clinic and the Seabrook Institute in San Francisco. He completed his Ph.D. in psychology with a multiple major in neuropsychology, psychoimmunology and psychotherapy. He is an associate fellow in the Society for Clinical Ecology, a consultant to the Science Advisory Committee of the Environmental Protection Agency as a neuropsychologist and behavioral toxochologist. He is eligible for board certification by the Academy for Psychosomatic Medicine and the American Academy of Behavioral Medicine. He has published numerous reference papers and a number of books, one of which books focused on the diagnosis of minimal brain dysfunction and the issue of psychosomatic versus somatic causes for behavior. He has presented two papers in conjunction with the Respondent on the issue of minimal brain dysfunction, tension disorders and the diagnosis of functional narcolepsy. Since 1980, Dr. Von Hilsheimer's practice has been split between psychotherapy and psychoimmunology. In the past ten years he has presented numerous continuing education workshops for physicians, which courses were certified by the American Medical Association. Dr. Dale K. Lindberg, M.D., was accepted as an expert witness for the Petitioner regarding the pharmacological effects, uses and indications of the drugs related to the charges in the administrative complaint. Dr. Lindberg has been a licensed physician in the State of Florida since 1959. He is board certified in nuclear medicine. He took a residency in nuclear medicine at Mt. Sinai Hospital in Miami Beach between the years 1974 and 1977. Since 1973, his practice has been limited to primarily that of supervising methadone maintenance programs and clinics. Prior to 1973 his practice was in the area of family practice, as well as nuclear medicine. He is a member of the Broward County Medical Association, Florida Medical Association, American Medical Association, Broward County Family Practice Association, as well as the Society of Nuclear Medicine. Dr. Lindberg has never treated a patient with narcolepsy nor has he seen patients exhibiting the various kinds of narcoleptic behavior. METHAQUALONE PRESCRIPTIONS; COUNTS I, II AND III The first three counts in the administrative complaint concern prescriptions written June 24, 1982, for allegedly excessive and unjustified amounts of a controlled substance, methaqualone, prescribed to patients Harri Klotz (Count I) , Sam Meiner (Count II) and Charles Meiner (Count III). Those prescriptions consisted of 121 sopor (150 mgs) for Harri Klotz; 189 parest for Sam Meiner; and 34 quaaludes for Charles Meiner, all of which are methaqualone medications. The Respondent received a telephone call on or shortly before June 24, 1982, the date the prescriptions were written, from a pharmacist whom he regularly dealt with, who informed him that, inasmuch as, effective July 1, 1982, he would be unable to fill methaqualone prescriptions due to a change in the law by which it became a Schedule I drug, that he would make available the small quantity of methaqualone remaining in stock to the Respondent for his patients who required the drug. The Respondent acknowledged having a few such patients and accordingly wrote prescriptions for the above odd numbers of capsules to patients whom had been regularly receiving methaqualone medication for a period of time previously. Patient Harri Klotz is the Respondent's wife. She has been a patient of Respondent since approximately 1940. She suffers from generalized osteo- arthritis involving mainly the hips, which was first diagnosed in 1967. Due to progressive severity of the disease she received surgery in October, 1970, in Germany, for replacement of both hip joints with artificial prosthesis. Since that time the right hip prosthesis joint cracked, causing her severe, chronic pain which caused her great difficulty in sleeping. After taking numerous combinations of medicine, Mrs. Klotz was found to respond most effectively to methaqualone, which induced sleep in spite of the pain, without undesirable side effects the next morning. She ultimately had the right hip prosthesis repaired. Her medical records indicate that this medication had also been prescribed for her by her treating physicians when the prosthetic devices were implanted. In 1981 she again began experiencing the same type of agonizing, chronic pain in her left hip and consulted an orthopedic surgeon at regular intervals concerning it. It was not until November, 1952, however, that the diagnosis was made that her left prosthesis had also broken. During the various attempts to diagnose the cause of this problem with her left hip, she was experiencing severe, chronic pain. Finally, after a third stint of surgery the left hip prosthesis was replaced and her symptoms ultimately improved. In the meantime however, on October 14, 1981, Respondent purchased 1,000 quaaludes for his wife. He did not dispense the entire lot to her, rather she was given 30 capsules at a time for use in inducing sleep during the period when she suffered from her painful condition at intervals of one and one-half to two months. The Respondent carefully monitored her dosage and kept the balance under lock and key at his office, duly recording on a dispensing record the capsules actually given to his wife on each occasion. On June 24, 1982, before methaqualone became a Schedule I Controlled Substance, he last prescribed that substance for his wife when he wrote the prescription for 121 sopor. He has not since prescribed a methaqualone substance to his wife. On June 24, 1982, the Respondent prescribed methaqualone to Sam Meiner. Mr. Meiner (Respondent's counsel) has been a patient of the Respondent since approximately 1968. Be suffers from a severe, chronic painful condition called regional enteritis, a condition characterized by severe, chronic pain and acute bowel spasms associated with acute exacerbations of the enteritis condition. As a result of this condition he has had two bowel resection surgeries, during the course of which surgeons removed approximately six feet of his small intestine. He has suffered from this disease chronically for approximately 18 years, having his first surgery in 1967 and the second in 1977. "hen the enteritis condition became acutely inflamed after his second surgery, he once again sought Respondent's medical advice. He has been a continuous patient of the Respondent ever since that time, seeing him almost on a weekly basis. Included in the total medical care Respondent has given this patient is a prescription of methaqualone for its beneficial soporific and antispasmodic effects designed to curtail the severity and duration of the bowel spasm incidents. Other physicians, as well as Respondent, in treating this patient have attempted many other combinations of medications before the Respondent and patient determined that methaqualone was the most effective modality. Since being under the Respondent's care with attendant methaqualone medication, the patient has required no hospitalization and has been able to lead a substantially normal existence, even though this disease or condition if unsuccessfully treated can ultimately prove fatal, especially if additional such surgical procedures are resorted to. Witness Meiner was shown to have no abnormal adverse effects nor physical or psychological dependence on the drug. It is now no longer legally obtainable, the patient being afforded his last prescription therefor on June 24, 1982, some six days before the prescription of the drug became illegal. On June 24, 1982, the Respondent prescribed 34 methaqualone capsules to Charles Meiner. Charles Meiner (also counsel for Respondent) suffers from a chronic, severe back injury involving a ruptured or degenerative disc. He periodically suffers excruciating, chronic back pain, resulting in his inability to sleep. He has been a patient of the Respondent since 1969. In 1973 he required hospitalization due to the severity of the back pain. lie has seen the Respondent for this problem at regular intervals ever since. He had been prescribed methaqualone on a number of occasions prior to June, 1982, as the medication helps his insomnia resulting from the chronic back pain, without imposing any adverse effect the following morning or inhibiting his ability to function in the legal profession. Be has never taken more than one tablet per day and some days only a half tablet during the course of his back pain flare- ups. In May of 1982, his back condition became particularly severe, with persistent pain. Because of this exacerbation of his back condition, he was given a prescription for 34 quaalude tablets on June 24, 1982, to relieve his pain and enable him to sleep. During the time Respondent prescribed methaqualone to these three above-named patients, methaqualone was an acceptable medication for relief of the symptoms these patients exhibited. Petitioner's witness Dr. Lindberg acknowledged that the prescribing of methaqualone by the Respondent to these patients on or before July 1, 1982, was for a medically justifiable purpose, and that the dosages involved were within recommended daily dosages for the treatment of the symptoms exhibited by these patients, as depicted in the Physician's Desk Reference (PDR) a work relied on by both parties throughout this proceeding. AMPHETAMINE PRESCIPTIONS: COUNTS IV, V, VII, XI, XII, XIII, XIV, XVI, XVII, XVIII and XIX. The prescription of amphetamines became restricted as to use by the enactment of Section 458.331(1)(cc) , Florida Statutes, effective August 30, 1980. This restricted the prescription of any drug which is an amphetamine or a sympathomimetic amine drug (a Schedule II drug) except, as pertinent here, for the condition of narcolepsy. Prior to the restriction of the drug, the Respondent had prescribed such drugs for short-term use for patients who were attempting to embark on a successful weight-control program. The Petitioner's expert witness, Dr. Lindberg, acknowledged that this was a medically appropriate use of this type of medication at the time and that he himself had made similar prescriptions for similar purposes. The Respondent conceded that as of July 3, 1980, that he was not aware of the change in the legal status of amphetamine type drugs by the enactment of the above statute, and did not become aware of such restrictions until the pharmacist with whom he regularly dealt informed him that he could not prescribe Biphetamine, Dexedrine or other sympathomimetics unless the patient had a narcoleptic condition. Upon becoming aware of this restriction after August 30,1980, the Respondent discontinued use of those drugs except for the treatment of narcoleptic symptoms in patients. Dr. Lindberg opined that the only type of narcolepsy he would recognize was "ideopathic narcolepsy." By this he meant that he would only diagnose narcolepsy when all four recognized symptoms are present: excessive daytime sleepiness, cataplexy (a condition when muscles become limp) , hypnogogic hallucinations (dreams shortly before going to sleep or upon awakening) and sleep paralysis whereby the patient is unable to move, although the limbs are not rigid. Dr. Lindberg has never treated a patient with narcolepsy nor has he ever observed a patient exhibit narcoleptic behavior in his practice. Both the Respondent and Dr. Von Hilsheimer, the Respondent's expert witness on the subject, have studied and treated this condition and published recognized research papers on the subject of narcolepsy. Further, the Respondent in connection with his speciality in the field of allergies, has performed testing regarding patients with certain food sensitivities and has observed that some of them will exhibit narcoleptic symptoms as a reaction to certain foods. Dr. Von Hilsheimer, as delineated above, has extensive experience in the diagnosis and treatment of narcolepsy in its various forms and in teaching recognition of the condition to doctors through continuing education courses. Idiopathic narcolepsy, the extreme or classic view of the disease, may involve exhibition of all four of the above symptoms in a patient, however, only 10 percent of patients legitimately diagnosed as narcoleptic present all four symptoms, and therefore most of the scientific and medical community uses the term "narcolepsy" In a broader, more general sense to mean essentially excessive, inappropriate daytime sleepiness, especially at inappropriate times. In addition to narcolepsy being a primary affliction, it can also be a subsyndrome, or secondary disorder related to a different medical problem. It can be permanent or can be a transient condition and can be a by-product of unusual psychological or physical stress. The Respondent prescribed a small dosage of an amphetamine for Nina Balabon between January 11, 1980, and September 17, 1982, at various times. (Count IV) Ms. Balabon is a 92 year old woman who has been taking a very small dosage of Dexedrine for many years. The dosage is substantially below that allowable for such a patient as conceded by the Petitioner and delineated in the Physician's Desk Reference. Ms. Balabon lives alone in Woodstock, New York, and is the foster mother of the Respondent's wife. She had been under the care of another physician who prescribed this course of treatment and drug for her so that she could remain alert enough to independently function and take care of herself in her own home. She is home-bound and after her doctor's death, she was unable to secure another doctor who would make house calls. She called upon the Respondent who is, in effect, a family member, and financially supports her, and asked him to prescribe the medication for her, in conjunction with which she retained the services of a visiting nurse. In her old age she has become afflicted with lassitude, inappropriate and excessive daytime sleepiness, depression and a diminished "will to live." The Respondent visits her in Woodstock, New York, periodically and he or his wife, telephone her at least once a week. A visiting nurse checks on her condition weekly and reports to the Respondent on her physical condition. The Petitioner's expert witness, Dr. Lindberg, has never seen this patient, but surmised upon her recorded weight that she is slightly malnourished. Accordingly, he opines that it is inappropriate to give a person with such a condition (slight malnourishment) amphetamines to curb her appetite and provide her "pep." The Respondent, however, did not prescribe amphetamine for this purpose. Be found, in the exercise of his medical judgment that she exhibits definite symptoms of narcolepsy. The dosage is extremely small and the patient is not shown to suffer any adverse effects therefrom. It was not shown that the dosage curbed her appetite, and indeed, Respondent established that the patient is not malnourished. She is a very small, slightly built woman and her mere recorded weight is not an indication in itself of malnourishment such that the prescription involved would be contraindicated. Petitioner's expert witness, further was unaware that the patient exhibited symptoms of narcoleptic behavior, and admitted that otherwise the dosages were quite small and not excessive for such a patient. Dr. Lindberg merely opposed the prescription of the medication because he believed that the law changed regarding the use of this drug, such that after August 30, 1980, it is only permissible for narcoleptic symptoms. In any event, the Respondent's diagnosis of the patient was uncontradicted and the 92 year old patient was shown to benefit from this treatment of her condition because it permitted her, with the assistance of the visiting nurse, to continue living independently rather than suffering commission to a nursing home or other institutional facility. Count VII concerns alleged prescriptions of amphetamines to one Doris Calloway between February 16, 1982 and October 13, 1982. Petitioner failed to introduce any evidence or testimony concerning this count. With regard to Count XI, Respondent prescribed on only one occasion, 50 Biphetamine capsules for Lori Carroccia on September 29, 1980. At the time this prescription was written and issued, the Respondent was unaware of the recent restrictions imposed by the legislature on the purposes for which amphetamine-type drugs could be prescribed by the passage of Section 458.331(1)(cc), Florida Statutes, effective July 1, 1980. The Respondent had known this patient for approximately six years and she was his nurse, employed at his clinic at the time the prescription was written. The single prescription was written when she complained to him of difficulty in starting a weight loss program and asked for his assistance. Prior to writing the prescription, he checked Ms. Carroccia's physical health, checked her weight and blood pressure, and indeed was already aware of her medical history because of his close association with her. During the entire two months she received this medication Respondent saw her on a daily basis and monitored her progress. The medication proved to be an effective means for her to develop a successful weight loss program. She suffered no adverse effects from receiving this drug. The Respondent only prescribed this medication once, in a small dosage to Initiate her weight loss program and not for the purposes of maintaining weight loss or a particular weight level through long-term prescriptions. Petitioner's sole expert witness conceded that the dosages were not excessive and were medically indicated in the PDR for the initiation of such a weight loss program. Petitioner's expert witness admitted that his opinion regarding inappropriateness of the prescription was solely predicated on the change in the legal status of the drug. The Respondent prescribed an amphetamine medication to patient Evelyn Lilly between April 14, 1981 and December 19, 1981 (Count XII). Ms. Lilly had been his patient since 1979 for allergy evaluation and treatment to alleviate chronic symptoms of runny nose, throat infections and irritations and sinus headaches. Respondent gave her an allergic evaluation in response to these symptoms. In completing her patient history he noted that Ms. Lilly suffers from rheumatism and arthritis. During the course of her allergy treatments Ms. Lilly's weight began increasing dramatically, with a worsening of her arthritic condition. Respondent noted she was markedly fatigued and became concerned about her general physical condition. In response to her fatigue or lassitude complaints, he initially performed a thyroid test in an effort to determine the cause of her lassitude and rapid weight gain. That test was inconclusive. lie then decided that between the complications of arthritis and her allergies he must reduce her weight before he could successfully treat either of those conditions. He initially prescribed Tenuate Dosepan which proved ineffective and then Ritalin, which also proved ineffective. She was then prescribed a course of Biphetamine. She responded dramatically to this medication with relief of her lassitude and the loss of 30 to 40 pounds. After noting that the initial sympathomimetic type drugs prescribed were ineffective and that the change to the Biphetamine produced markedly successful results, Respondent came to the conclusion that the patient was narcoleptic. Narcolepsy sometimes is not alleviated with the prescribing of one type of sympathomimetic drug when the switch to treatment with another type will suddenly prove to be successful in alleviating the narcoleptic symptoms. The doctor's chart for this patient did not definitely indicate the purpose of the prescription of the amphetamine medication, although Dr. Klotz candidly responded in his testimony that it may have been in part for weight control because a reduction in weight would help alleviate her arthritic joint problems. However, inasmuch as narcolepsy can be indicated when one type of sympathomimetic drug will not relieve its symptoms and another type will and since is. Lilly in her reaction to the medications displayed this phenomenon, Respondent, in the reasonable exercise of his medical judgment concluded that she displayed symptoms of narcolepsy. This view is corroborated by Dr. Von Hilsheimer. He has had more than 1,000 patients referred to him over the years by the Respondent. Approximately one-third of these patients were obese and yet he was only aware of four such patients who were treated with biphetamines by the Respondent. Be thus concludes that the Respondent used some differential reason other than mere weight control for prescribing biphetamine which led to the diagnosis of symptomatic narcolepsy with Ms. Lilly. The Petitioner's expert witness once again felt that the Biphetamine and Ritalin prescriptions for Ms. Lilly were inappropriate and excessive, but acknowledged that his criticism of these prescriptions was predicated solely on the fact that the medication had become illegal for prescription for weight control purposes before Ms. Lilly's prescriptions were made. Dr. Lindberg ultimately agreed however, after consulting the PDR that the amounts and types of medication were within appropriate indications, dosage limits and amounts and thus the amounts prescribed were within the reasonable exercise of the Respondent's judgment as a physician for the symptoms displayed, and alleviated them. Concerning this patient, as with all the others involved herein, Petitioner's expert witness bases his testimony merely on the doctor's patient chart which does not specifically refer to narcoleptic symptoms. Respondent admits his records are not detailed in all cases, since the patients were not referrals, but were his patients for many years such that he was intimately familiar with their histories and conditions. Based on the lack of reference to narcoleptic symptoms in the records themselves, Dr. Lindberg opined that the prescription was medically inappropriate, however, the mere absence of reference to that condition in the medical records alone does not establish the medical inappropriateness of the prescription, especially in view of the Respondent's showing (corroborated by Dr. Von Hilsheimer) that indeed Ms. Lilly was narcoleptic. Mr. Emmett Peter was prescribed biphetamines between October 16, 1979 and September 14, 1982 by the Respondent (Count XVI). Mr. peter has been Respondent's patient since 1969 and `gas definitely diagnosed as a narcoleptic individual by a physician who treated him prior to that time and related that fact in his initial medical history provided Respondent. At the time he and his wife became patients of the Respondent, Mr. Peter was receiving a medication called Obedrin, which is a dexedrine-type drug. During the entire time he received medication from the Respondent, he periodically visited the Respondent on his own behalf, as well as accompanying his wife to the Respondent's clinic for treatment, at which times the Respondent also observed Mr. Peter. Although the Respondent was unaware of the change in the law regarding restriction of the use of amphetamines to the treatment of narcolepsy at the time he prescribed Mr. Peter's medications at issue in this case, he continued to prescribe the medication for Mr. Peter after he became aware of the law, because he definitely diagnosed Mr. Peter to be a narcoleptic. The Respondent's expert witness, Dr. Von Hilsheimer, has seen both Mr. and Mrs. Peter on a professional basis as a researcher. He had numerous occasions to observe Mr. Peter, approximately twice a week from March, 1980 through May, 1982. Be became quickly aware of the fact that Mr. Peter was narcoleptic due to the fact that Mr. Peter, when waiting for his wife at Dr. Von Hilsheimer's office, often fell asleep in a very dramatic way, sometimes even when Dr. Von Hilsheimer was engaged in conversation with him. It was thus established that Mr. Peter, based upon his medical history and the personal observation of both Dr. Klotz and Dr. Von Hilsheimer, suffers from a minimal brain dysfunction manifested as excessive, inappropriate sleepiness. Dr. Von Hilsheimer further noted that Mr. Peter's condition is also characterized by moderate cataplexy, another symptom of narcolepsy. There is no question that Mr. Peter suffers from narcolepsy, therefore the prescription of amphetamine medications to Mr. Peter was clearly medically appropriate and the Petitioner admitted that the amounts of the medication were not excessive. On February 24, 1981, Charne D. Porter, the Respondent's daughter was given a prescription for 30 10-mg Ritalin tablets (Count XVII). The Respondent has been her treating physician most of her life. At the time the prescription was written she was editing and producing a motion picture. She was working very long hours and complained to Respondent that she was having difficulty staying awake during all times of the day and in completing her film-editing work. Prior to this period of time however, her typical work schedule involved such long hours with no apparent ill effects. This was not an unusual work schedule for her. Dr. Von Hilsheimer has known Ms. Porter since 1979 and she has consulted him professionally in the past. He was quite familiar with the patient history and had occasion to see her during the time the medication involved was prescribed. During this period of time he found that when she was attempting to do film-editing work which is normally a stimulating, arousing type of endeavor, she did not have her normal responsiveness and while talking to him would doze off in the middle of a conversation in his office. The work she was trying to do at the time was quite arousing under unusual conditions of lighting and interest and yet she would still doze off at inappropriate times during the day while working. The doctor did not find that her long work schedule or hours were responsible for such a condition. Ms. Porter had a debilitating illness consisting of the lingering aftereffects of a form of hepatitis and this, coupled with the stress related to her film-editing job (for which she was obtaining treatment through self-hypnosis training by Dr. Von Hilsheimer) caused her to lose her normal "arousal ability." Because of this she did have an attack or episode of transient narcolepsy as diagnosed by Respondent and Dr. Von Hilsheimer. During visits in his office he observed her display three of the four commonly recognized symptoms of narcolepsy during approximately the same period of time in which she received the Ritalin prescription. These inappropriate sleep episodes were a transient condition and Ms. Porter recovered from that condition and is functioning well personally and professionally. The small original Ritalin prescription needed no renewal. The use of the Ritalin prescription was a reasonable exercise of Respondent's medical judgment and approach to alleviating the transitory narcolepsy symptoms exhibited by Ms. Porter and caused her no harm whatever. Patient Sandy Lee Bradford was prescribed Biphetamine between December 14, 1980 and December 15, 1981. She is the daughter of the Respondent's secretary and has been the Respondent's patient for many years. On December 15, 1980, due to her complaint of fatigue, daytime sleepiness episodes, along with inability to lose weight and excessive weight gain, the Respondent first prescribed biphetamines to her. Over a one year period she subsequently received four other prescriptions of biphetamines. Each time she received a new prescription, she personally saw and consulted with Dr. Klotz. At the time the prescriptions were administered she had recently been divorced and was suffering unusual stress and emotional anxiety related to that divorce, which Respondent believed had a direct effect on her sudden weight gain and inability to lose weight. At the time the Respondent made these prescriptions, he was as yet unaware of the change in the legal status of amphetamine-type drugs such that it was no longer legally permissible to prescribe them for weight loss purposes. The Respondent candidly admitted that he primarily prescribed the drugs for assisting her in embarking on a successful weight loss program, not for chronic use. Other anorectic medications had been tried on this patient and had proved ineffective, however, with the judicious prescription and use of the biphetamine medication the patient made substantial progress in losing weight and in alleviating symptoms of fatigue. When Respondent became aware of the change in the legal status of biphetamines, he discontinued that medication promptly and substituted Tenuate Dosepan, which proved ineffective. He then substituted Ionamine which also proved ineffective, in an attempt to avoid prescribing biphetamines for the patient. The biphetamines prescribed were in appropriate, non-excessive quantities for the condition and symptoms exhibited by the patient and successfully alleviated her complaints with no harm to the patient. He discontinued biphetamines because he felt he could not with reasonable medical certainty, diagnose her as a narcoleptic patient. Dr. Lindberg conceded that the prescriptions were medically appropriate, but for the change in the law regarding their permissible use, and that change was the sole basis for his opinion that the prescription was inappropriate. Patient Trudy Heintz was prescribed Dexedrine between January 3, 1980 and October 29, 1982. She has been a patient of the Respondent since the early 1950's. She has displayed, over many years, symptoms of excessive, inappropriate daytime sleepiness and a simple inability to perform her employment duties as a result. The Respondent was treating her for phlebitis and arthritis, and thus she is an internal medicine patient. As such the Respondent monitored her physical condition quite closely, making physical examinations including monitoring of blood pressure when necessary. He observed no adverse effects caused by the administration of Dexedrine to this patient, which alleviated her narcoleptic symptoms and enabled her to remain productive and fully functional in her employment and daily pursuits. The Respondent thus diagnosed her as suffering from narcolepsy and established that as an appropriate basis for the prescription of Dexedrine. He continued to prescribe Dexedrine for the patient, even after he became aware of the restriction of its use because he genuinely believes that she is a true narcoleptic. Dr. Lindberg opined that the Dexedrine was inappropriate medication and was prescribed in excessive amounts. He did not believe that Ms. Heintz exhibited narcoleptic behavior, but he had never observed the patient and based his opinion merely upon less than detailed references to narcoleptic behavior in the patient's records. The Respondent, however, established that this patient had been a patient for many years and he was intimately familiar with the physical condition, complaints and medical history, and makes notes only for his own use. Because of his familiarity with her medical history and problems, it was unnecessary for him to make his own notes in sufficient detail so that Dr. Lindberg would be able to thoroughly review the patient's status and treatment indications by looking at her chart alone. Dr. Lindberg, in opining that the dosage was excessive at 30 mg. per day failed to take into account that the PDR provides that the accepted prescription of Dexedrine for narcolepsy is from 5 mg to 60 mg per day with no time limitation as to its use. His opinion as to excessiveness was based on the medical indications in the PDR for obesity only, not for narcolepsy. Such a dosage for this patient was not excessive in view of her proven diagnosis of narcolepsy. Count XXI concerns the purchase on October 14, 1981, of 1,000 quaalude tablets with regard to which it is alleged that the Respondent failed to maintain proper records justifying purchase and disposal of them as allegedly required by Section 21 USC 1306.04(b). Section 21 USC 1306.04(b) has not been placed in evidence in this proceeding, nor has it been made the subject of judicial notice, pursuant to Section 120.61, Florida Statutes. In any event, the 1,000 quaalude tablets were purchased by the Respondent for use by his wife, Harri Klotz. The Drug Enforcement Administration (DEA) Form 222, required to be maintained by the purchaser of such drugs was maintained by the Respondent and his office manager, and a dispensing record also maintained by them shows that the medication was dispensed upon receipt to Respondent's wife. In fact the drugs were established to be retained in the Respondent's office under lock and key and not physically dispensed to the Respondent's wife at one time, rather they were dedicated to her use, but maintained securely on the Respondent's office premises. Mrs. Klotz was then dispensed 30 tablets at a time in approximately one and one-half to two month intervals, and an additional journal card was established by Ms. Lindblom, the office manager, showing the dates when Mrs. Klotz drew down upon that medication in 30 tablet increments which withdrawals were recorded ads "pills dispensed." Additionally, the 130 methaqualone tablets prescribed for Mrs. Klotz on June 24, 1982, were for the purpose of providing her an additional supply to be used in a light, periodic, controlled manner because the drugs were about to become illegal. Later in August or September, 1982, Ms. Lindblom, when she became aware that the additional prescribing of methaqualone might be illegal, upon advice of Mr. Meiner, the Respondent's counsel, elected to dispose of the remaining quaalude tablets at which time 790 of the original 1,130 tablets dedicated to the use of Mrs. Klotz remained at the Respondent's office and were disposed of. Thus the receipt of 1,000 quaalude tablets was duly recorded in Respondent's record and the 30 tablet dispensations of the medication periodically from October 14, 1981 through June 28, 1982, were recorded in a dispensing record in evidence, which record also reflects the disposal of the 790 unused tablets.
Recommendation Having considered the foregoing Findings of Fact and Conclusions of Law, the evidence of record and the candor and demeanor of the witnesses and the pleadings and arguments of counsel, it is, therefore RECOMMENDED: That the Administrative Complaint against the Respondent, Solomon D. Klotz, be DISMISSED except as to the minor violations of Section 458.331(1)(h) and (cc) Florida Statutes, proven with regards to Counts XI and XVIII for which, under the circumstances of this case, no disciplinary action should be taken. DONE and ENTERED this 4th day of May, 1984, in Tallahassee, Florida. P. MICHAEL RUFF 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 4th day of May, 1984. COPIES FURNISHED: Joseph W. Lawrence, II, Esquire Chief Attorney Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Sam C. Meiner, Esquire 26 Wall Street Orlando, Florida 32801 Helen C. Ellis, Esquire 1804 Old Fort Drive Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
Findings Of Fact Petitioner is the governmental agency responsible for issuing licenses to practice medicine and for regulating such licensees on behalf of the state. Respondent practices general medicine under license number ME 0042559. The parties stipulated to all material facts alleged in the Corrected Second Amended Administrative Complaint except one. The disputed fact is whether Respondent maintained adequate medical records of her treatment of patient R.W. with Lortab. Lortab is a legend drug within the meaning of Section 465.003(7). It contains hydrocodone. Hydrocodone is a Schedule III controlled substance in Chapter 893. On April 7, 1989, Respondent signed a prescription for 30 Lortab 7.5 mg tablets as an analgesic medication for a toothache. Respondent's medical records contain no entry for R.W.'s office visit on April 7, 1989, and no entries disclosing the nature of R.W.'s complaint, diagnosis, plan of treatment, or justification for prescribing Lortab. On January 5, 1990, Respondent prescribed Indocin 7.5 mg., an anti- inflammatory medication, and Lortab 7.5 mg. for R.W.'s shoulder pain. Respondent's medical records contain no entries documenting the examination of R.W., exam results, or diagnosis. There is no justification in Respondent's medical records for prescribing Lortab for R.W. on January 5, 1990. In addition, Respondent failed to document the number of Lortab tablets prescribed for R.W. on January 5, 1990. On January 26, 1990, R.W. complained of pain in his right shoulder secondary to an injury sustained while pushing a car. Respondent again prescribed Lortab 7.5 mg. Respondent did not document in her medical records the number of Lortab tablets prescribed. On February 25, 1990, R.W. advised Respondent that he had reinjured his shoulder in a fight. Respondent instructed R.W. to wear a sling and rest. Respondent again prescribed Indocin and Lortab 7.5 mg. On May 4, 1990, R.W. again complained of shoulder pain. Respondent performed an x-ray of R.W.'s shoulder. Respondent's medical records do not document that the x-ray was taken or the results of the x-ray. On May 4, 1990, Respondent diagnosed R.W. with possible rotator cuff tear. Respondent prescribed Indocin and Lortab 7.5 mg. Respondent's medical records do not document the number of Lortab tablets prescribed. Respondent did not know the number of Lortab tablets R.W. received or the number he took each day. Respondent's medical records do not document Respondent's instructions concerning the number of tablets to be taken each day or the frequency with which the tablets were to be taken. Respondent's medical records do not document the number of refills R.W. was given. On May 24, 1990, Respondent's medical records document that she warned R.W. of the potential for addiction to Lortab. However, Respondent continued to prescribe Lortab without documenting the amount of Lortab prescribed for R.W. Respondent failed to keep written medical records justifying the course of treatment for R.W., including patient history, examination results, and records of drugs prescribed. Respondent failed to document patient history on April 7, 1989. Respondent failed to document x-ray examination results on May 4, 1990. Respondent failed to document Lortab prescribed, dispensed, or administered from April 7, 1989, through July, 1990.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a Final Order finding Respondent guilty of violating Section 458.331(1)(m), reprimanding Respondent, imposing a fine of $3,000, and placing Respondent on probation for one year pursuant to the terms of probation prescribed herein. RECOMMENDED this 21st day of April, 1995, in Tallahassee, Florida. DANIEL MANRY Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399 (904) 488 Filed with the Clerk of the Division of Administrative Hearings this 21st day of April 1995.
The Issue The matters presented for consideration in this case concern an administrative complaint brought by the Petitioner against the Respondent. That complaint alleges violations of various provisions of Chapter 458, Florida Statutes. Those sections of law are more particularly described in the conclusions of law in this Recommended Order. In summary, Respondent is alleged, in the course of his relationship with patients under his care, to have prescribed numerous controlled substances which were in excessive amounts, and were not appropriate prescriptions for the medical problems experienced by the patients, and were not prescribed in the course of the Respondent's professional practice. In the face of these circumstances, Respondent is accused of having committed gross or repeated malpractice in failing to recognized by reasonably prudent similar physicians in his community. Respondent is also accused of having failed to keep written medical records justifying the course of treatment.
Findings Of Fact Teotimo D. Bonzon, M.D., is a physician licensed to practice medicine in Florida through licensure by the State of Florida, Department of Professional Regulation, Board of Medical Examiners, license No. MF0016786. He has held this license at all times relevant to this inquiry and during this period has practiced medicine at 830 Gary Street, Jacksonville, Florida, and 6229 Merrill Road, Jacksonville, Florida. At present, Respondent does general surgery approximately three times a week and sees 30-35 patients a day in his general office practice. Dr. Bonzon is a graduate of the medical school, Far Eastern University, Manila, the Philippines. The date of his graduation was 1961. In 1962, he took his internship at St. Francis Hospital in Jersey City, New Jersey. There followed five years of general surgery training at Booth Medical Center in Flushing, New York, and York Hospital in York, Pennsylvania. Respondent then took a year of surgical fellowship at the Community General Hospital of Syracuse, New York. Following this practice, Respondent stood examination for medical license to practice in the State of Florida, and in the States of Pennsylvania and Indiana. Having passed those examinations, the decision was made to move to Florida. Respondent arrived in Florida in June of 1971 and has been involved in the practice of general surgery and general office practice since that time. The initial two years in practice in Florida were primarily concerned with general surgery and industrial medicine, which relates to provision of care for those persons who have been injured in industrial accidents. The administrative complaint, which is the subject of this controversy, dates from March 10, 1982, and is the result of a survey made by the State of Florida, Department of number of Schedule II controlled substances per Chapter 893, Florida Statutes, which had been prescribed by physicians who practice in the Jacksonville, Florida, area. This survey transpired over a period of approximately six months, beginning in the fall of 1981. After being properly served with the administrative complaint, Respondent made a timely request for a formal hearing pursuant to Subsection 120.57(1), Florida Statutes. ARTHUR LEE SCHEIDER (Counts I, II, IV, V) Dr. Bonzon first saw Arthur Scheider in his office on May 29, 1979. At that time, the chief complaints of the patient had to do with "nerves, that the patient could not sleep, that he itched and broke out in a rash." These matters are reflected on the copy of the patient's records, which are admitted as Petitioner's Exhibit C. Additionally, it was noted that the patient had been utilizing methaqualone or Quaaludes for one year prior to being seen by Dr. Bonzon. Scheider had also been receiving Valium in 10 milligram amounts. On this date, Dr. Bonzon prescribed 100, 300-milligram Quaaludes to assist the patient in sleeping and 100, 10-milligram Valium tablets related to the nervous problem being experienced by the patient. Both of these drugs are Schedule II controlled substances with a potential for abuse by those persons for whom the prescription has been given. Methaqualone is a sleep producer. Valium is a muscle relaxer. Scheider was again seen on August 20, 1979, still complaining of nervousness and problems with sleep together with a rash condition on his torso and extremities. At that time, a further prescription of Quaaludes in the amount of 100 at 300-milligram each and Valium in the amount of 100 at 10- milligram each were prescribed for the patient with the opportunity for one refill related to the Valium. On November 1, 1979, the patient returned and based upon a diagnostic note in the patient's records to the effect that the patient needed nerve medicine, a further prescription Valium with opportunity for one refill was prescribed. These prescriptions were given on November 1, 1979, before the amounts related to the August 20, 1979, prescription for Quaaludes and Valium had been exhausted. This is based upon Dr. Bonzon's appropriate recommendation that no more than one Valium and one Quaalude tablet be taken per day. On January 7, 1980, a brother of the patient Scheider asked for Quaalude medication and was denied. The request for medication is reflected in the aforementioned exhibit related to patient records of Scheider. Scheider was again seen on March 14, 1980, complaining of laryngitis, cough, and of a fever in the range of 100 degrees. On that date, in addition to other medication, 100, 300-milligram Quaaludes and 100, 10-milligram Valium were prescribed for the patient. No explanation is made as to why Quaaludes and Valium were prescribed. On May 19, 1980, the patient record reflects that 50, 10-milligram Valium were prescribed for the patient Scheider; no indication is made as to the reason for this prescription. The Valium prescription was given at a time prior to the exhaustion of the March 14, 1980, prescription for Valium based upon a utilization rate of one Valium tablet per day. On June 11, 1980, a sister of Arthur Lee Scheider's called and spoke to the Respondent and told the Respondent that Arthur Lee Scheider had been selling Valium to Scheider's mother. As a consequence, Dr. Bonzon noted in the patient record that he would not prescribe Valium for Scheider in the future and in fact abided by this choice. Respondent did prescribe 100, 300-milligram strength methaqualone tablets on this date. On September 12, 1980, Scheider was again seen by the Respondent reference an examination which led to the conclusion that the patient needed an operation related to a circumcision. At that time, 100 additional 300-milligram Quaaludes were prescribed for the patient. Prescribed methaqualone or Quaaludes for the patient Scheider, it was always on the basis that Dr. Bonzon felt that the patient needed assistance in sleeping. Although not reflected in the medical record, Bonzon had suggested to Scheider that he see a psychiatrist in trying to combat his problem with sleep; however, Scheider declined this suggestion and the Respondent continued to prescribe methaqualone or Quaaludes. These prescriptions of 100 were made, notwithstanding the fact that the Physicians' Desk Reference indicated that methaqualone or Quaaludes should be prescribed in "small quantities." Respondent believes that this suggestion is a relative matter and really intends that the patients not be allowed to take more than one methaqualone tablet per day, an erroneous assumption. Respondent learned of Scheider's trafficking in the controlled substance, methaqualone, on November 25, 1980, and made a note in the patient's file that the patient had been arrested for this activity and that no more medication should be prescribed for this patient for drugs which were under "narcotic control." It was also indicated that appointments for this patient should pertain to other medical problems unrelated to controlled substances. Dr. Ensor R. Dunsford practices medicine in Jacksonville, Florida. He has, during his career, practiced in general surgery and is board certified in that field. His present practice involves emergency treatment in a freestanding emergency care facility. Upon examination of the patient records related to Arthur Lee Scheider, involving the prescription of methaqualone and Valium over the period May 19, 1979, through September 12, 1980, Dr. Dunsford was of the opinion that the act of prescribing was "grossly overdone." Further, Dr. Dunsford felt that this amount prescribed was risky for a patient because of the potential for abuse. If the patient has an emotional need for the substance, then the risk is there that a physical need might be created. In summary, Dr. Dunsford felt that the number of Valium and methaqualone tablets which were in the best interest of the patient. Moreover, Dr. Dunsford felt that the amounts of methaqualone and Valium which Respondent prescribed for Scheider over the period of time were not acts of a "reasonably prudent physician" related to practicing medicine with a level of care, skill and treatment performed by a similar physician in the community. Dr. Dunsford also expressed the opinion that the decision to prescribe the additional methaqualone or Quaaludes on June 11, 1980, and September 12, 1980, after receiving information that the patient was selling a controlled substance (the information of June 11, 1980, from patient's sister related to Valium) was inappropriate and a reflection of substandard medical judgment. To Dr. Dunsford, the information that was given by the sister of patient Scheider was a "red flag" waving in the face of the practitioner, Dr. Bonzon. Dr. Dunsford also states that the September 12, 1980, medical record does not establish a basis for prescribing Quaaludes related to symptomology of the patient. The record makes no reference to the problem with sleeping and pertains only to scrotal erythema, parietitis and the need for circumcision. Finally, given the facts of the prescriptions from May 29, 1979, through September 12, 1980, with emphasis on the information related to suspected drug sales which was imparted on June 11, 1980, Dr. Dunsford feels that a reasonably prudent physician would not want to be involved with that type of situation, i.e. prescribing the drugs on June 11, 1980, and September 12, 1980. All opinions, as expressed by Dr. Dunsford found above are accepted. Dr. Apolinar C. Ilano gave testimony. Dr. Ilano practices in Jacksonville, Florida, as a general surgeon. Dr. Ilano agrees with Dr. Dunsford that methaqualone has a potential for abuse. Following review of the patient records of Arthur Lee Scheider, Dr. Ilano's opinion was that some record had been made which justified the prescription of methaqualone for the sleep problem of Scheider and Valium related to the nervous problem of that patient. The justification found by Dr. Ilano does not satifactorily explain the lack of explanation for prescribing methaqualone on September 12, 1980, as referred to by Dr. Dunsford. Dr. Ilano did not feel that the amounts of methaqualone and Valium that were prescribed to Scheider were excessive or inappropriate or contrary to good judgment by reasonably prudent similar physicians in that there was some justification for prescribing the medication to be found in the record; no indication in the record that the patient was abusing Valium, as opposed to sticking to the amount or dosage prescribed, and the rationalization that Dr. Bonzon was attempting to limit the number of office visits by prescribing the high amounts of methaqualone and Valium. The opinion expressed in the prior sentence is not compelling in the face of facts presented and the more acceptable explanation offered by Dr. Dunsford. Even Dr. Ilano was concerned about prescribing methaqualone after learning that the patient was possibly selling Valium, although his opinion did not reach the level of finding fault with the quality of care offered by Dr. Bonzon in prescribing methaqualone after being informed of the possible sale of Valium, as Dr. Dunsford had. Again, Dr. Dunsford's opinion is accepted on this topic. Dr. Ilano correctly states that if the patient is selling Valium he might in turn sell methaqualone. Dr. Osbey L. Sayler gave testimony related to the care and treatment of Arthur Lee Scheider. Dr. Sayler practices in Orange Park, Florida, and is a board-certified general surgeon. The sum and substance of Dr. Saylor's opinion of Dr. Bonzon's care and treatment of Arthur Lee Scheider was to the effect that Dr. Bonzon had done nothing inappropriate as alleged in the various counts pertaining to that patient. After considering this opinion testimony and that of the other physicians, Dr. Saylor's opinions are accepted to the extent that they describe methaqualone as being an addictive or habit-forming drug which has been resorted to by persons attempting suicide and which is sold on the street as a "downer" and his opinion that Valium has a potential for abuse and can be addictive. Otherwise Dr. Sayler's opinions are rejected. GLADYS KNIGHT (Counts VI, XII, and XIII) Respondent treated the patient Gladys Knight over a period of years. During that time, the patient was seen on April 28, 1981, and was prescribed 30, 10-milligram Ritalin tablets. Ritalin is a Schedule II controlled substance. A notation of the prescription may be found in Petitioner's Exhibit D admitted into evidence, a copy of the patient records kept by the Respondent related to Gladys Knight. As established through the testimony of Dr. Dunsford, no indication is made in those records of an acceptable reason for prescribing Ritalin which is in the category of amphetamine or sympathomimetic amine drugs, spoke to in Section 458.331(1)(cc) , Florida Statutes. The underlying diagnostic impression upon the April 28, 1981, visit, according to the patient records related to complaints of the inability to get out of bed because of fatigue and insomnia. Remarks are also made in that entry that the patient is without energy and is complaining of arthritis pain in her right shoulder. None of these matters comport with a justifiable basis for prescribing ritalin as allowed in Section 458.331(1)(cc), Florida Statutes. In discussing the prescription of Ritalin, Dr. Bonzon indicated in the course of the hearing that he recognized Ritalin to be a central nervous system stimulant, which it is, and that he prescribed it for Mrs. Knight on April 28, 1981, because of his perception of signs of depression in that patient. More particularly, Dr. Bonzon indicated that she had claimed she didn't have energy, didn't want to get out of bed and was recalling a time when her husband was still alive. As a consequence, Bonzon felt that on this one occasion, in his medical judgment, Knight would benefit from a short term use of Ritalin. This was the only prescription of that substance for the patient. No mention was made in the patient record of the depressed condition; however, this impression which was given of the patient's condition in the course of the hearing is not sufficient justification for the prescription of Ritalin, "depressed state" not being one of the accepted bases for prescribing Ritalin as related in Section 458.331(1)(cc), Florida Statutes. Respondent also prescribed Preludin to the patient, Gladys Knight, commencing February 22, 1979. Preludin is a Schedule II controlled substance. This drug was prescribed for purposes of weight control. On the initial date, the patient was provided with 30 tablets with the opportunity for three refills. At that time, the patient weighed 148 pounds. The patient was seen again on August 14, 1979, for weight control and 50 Preludin tables were prescribed with the opportunity for one refill. This visit was made with a Dr. Lagman. At that time, the patient weighed 145 pounds. On September 27, 1979, the patient was seen by the Respondent and was given a further prescription of Preludin to control her weight. She weighed 143 pounds upon that visit. On December 3, 1979, the Respondent saw the patient again and prescribed Preludin in the amount of 100 tablets for weight control. At that time, the patient weighed 146 pounds. Finally, the patient was seen by the Respondent on February 14, 1980, her weight was shown to be 143 pounds and she was given a further prescription of Preludin in the amount of 100 tablets. This was on prescription by Respondent. Knight had been instructed by the Respondent on the occasion of prescribing Preludin on the question of how to utilize the Preludin tablets. At the time Respondent prescribed Preludin for patient Knight, he was unaware that the drug was an amphetamine or sympathomimetic amine drug. Respondent also discovered that Preludin prescriptions could not be refilled when a pharmacist contacted him in August of 1979 reference an effort by Knight to refill a prescription. Dr. Dunsford had reviewed the patient records related to Gladys Knight, particularly as it related to the prescription of Preludin. He identified that Preludin has been prescribed to assist obese people in weight control through the devise of suppressing the appetite of those patients. Because of a potential for abuse, Preludin is only prescribed for utilization over a period approximating a few weeks, per Dr. Dunsford. His testimony about Preludin, related to utilization, appropriate limits of its use, and potential for abuse is accepted. Dr. Dunsford felt that the Preludin had been over prescribed in the sense of amounts being too large on each prescription and over too long a period of time. Dr. Dunsford placed particular emphasis on the lack of wisdom in prescribing 100 tablets of Preludin on one occasion and felt that would be excessive and inappropriate. These opinions are accepted. Moreover, the opinion by Dr. Dunsford that the pattern of prescribing Preludin for Knight were not the actions of a reasonably prudent physician, under similar conditions and circumstances, is found to be correct. Dr. Ilano did not feel that the amount of Preludin was excessive nor did he feel that the actions of the Respondent constituted a failure to practice medicine with the care and skill that a reasonably prudent physician, under similar conditions and circumstances, would pursue. Dr. Ilano's opinion is not accepted. Nor is the opinion of Dr. Saylor related to the treatment of Mrs. Knight utilizing Preludin found to be compelling when he speaks favorably to treatment choices by the Respondent. JOHN BROUGHTON (Counts VIII, IX, X and XI) John Broughton was a patient of the Respondent in the time period August 13, 1979, through February 16, 1981. Records related to the treatment of Broughton are found as part of the Petitioner's Exhibit E admitted into evidence. During the treatment of Broughton, beginning on August 13, 1979, 40 Preludin, 75-milligram tablets were provided for weight control. Preludin, 75- milligrams was again prescribed for control on September 21, 1979, following examination by Respondent. On October 31, 1979, Dr. Bonzon saw Broughton and prescribed Preludin 75-milligram in the amount of 60 tablets related to weight control. On December 31, 1979, an additional 80 tablets of 75-milligrams Preludin was prescribed by Respondent for the benefit of Broughton. On March 13, 1980, 100, 75-milligram preludin tablets were given to Broughton on prescription issued by Respondent. On June 4, 1980, 50, 75-milligram Preludin tablets were prescribed by Respondent for Broughton. Respondent denied Broughton a request for Preludin upon an office visit on July 28, 1980, to see how the patient would react without the drug. On November 3, 1980, Preludin, 75-milligrams in the amount of 40 tablets was prescribed by Respondent for Broughton for weight control and a notation made that no further prescription would be written unless 40 days had transpired. On December 11, 1980, without examining the patient, Preludin was prescribed for an unidentified condition. The strength of the Preludin was 75-milligrams and 50 tablets were authorized by the prescription issued by Respondent for the benefit of Broughton. Other evidence in the hearing demonstrates that this Preludin was prescribed for weight control on that visit. During the course of the treatment, Broughton lost approximately 20 pounds in weight. In the interval of treatment, Broughton had requested Respondent to prescribe additional Preludin tablets and had been advised by Respondent that they would not be forthcoming based upon the fact that sufficient time had not transpired to have utilized one tablet per day on the previous prescription. In addition, the Preludin was not prescribed for Broughton if his blood pressure was too high upon examination by Dr. Bonzon. At the time Dr. Bonzon prescribed Preludin in November and December, 1980, as identified before, he was unaware that Preludin, an amphetamine or simpathomimetic amine drug, could not be prescribed for weight control after July 3, 1980. 1/ On August 13, 1979, Talwin was prescribed for Broughton by the Respondent upon an office visit. The explanation for this prescription says for "hip." In particular, it related to the provision of pain medication. Talwin, as with the case of Preludin, is a Chapter 893, Florida Statutes, controlled substance with addictive qualities. Talwin is, in effect, a pain medication. On September 21, 1979, a further prescription of Talwin was prescribed by Respondent for Broughton upon an office visit. This Talwin in 15-milligram strength, 40 tablets with opportunity for a single refill. No indication was made in the record as to the basis for prescribing this pain medication. Between August 13, 1979, and September 21, 1979, there is a notation in the patient records effective August 28, 1979, of a refill of Talwin in 50-milligram strength, 30 tablets and a further indication of Talwin being prescribed, 50- milligram strength, 30 tablets on September 13, 1979. On November 8, 1979, the patient record shows a refill of Talwin in the amount of 50 tablets. On November 16, 1979, the file establishes that the patient said he had been caught in the rain and his bottle got wet and that the Talwin turned to mush and a prescription was written in the amount of 50 Talwins to replenish Broughton. Broughton verified this story in the course of his testimony at hearing. The pills had not been destroyed but the Respondent did not know this at the time the prescription was written on November 16, 1979. The records reflect a notation on that date that no refills of Talwin should be given until November 28, 1979. On December 31, 1979, the patient was seen by Respondent for a problem he was experiencing with a hernia condition and a cough, congestion, and headaches. On that date, Talwin in, the 50-milligram strength, 50 tablets was prescribed. On the dates January 22, 1980; February 10, 1980; and February 28, 1980, patient records show prescription of Talwin in the 50-milligram strength, 50 tablets on each of those dates. The patient was seen by Dr. Bonzon on March 30, 1980, complaining of the hernia condition and a prescription was written for 50 Talwin, 50-milligram tablets. On June 4, 1980, the Respondent saw Broughton and prescribed 50 Talwin in 50-milligram strength. On July 28, 1980, Respondent saw Broughton and discussion was made of establishing surgery for hernia repair. Talwin was prescribed in a 50-milligram strength, 50 tablets with an indication of no refill, as established in the patient records. On August 25, 1980, an indication is made in the patient records that Talwin, 50-milligram strength in the amount of 40 tablets was prescribed for the patient. On October 10, 1980, patient records show that Talwin was refilled. On November 10, 1980, patient records reflect that a Pic N Save Drug Store had received a request for refill of Talwin in the amount of 40 tablets and this request was denied by the doctor's office based upon the fact that a refill had just been given on November 3, 1980. On November 20, 1980, the records reflect that the Pic N Save at Sandlewood was given a prescription of Talwin, 50-milligram strength in the amount of 40 tablets for benefit of Broughton. On December 8, 1980, the patient was seen by Respondent. It was noted in the record that Talwin in the strength of 50-milligrams, 20 tablets had been prescribed two days before. Other evidence does not clarify whether that prescription was indeed written. On December 19, 1980, the patient records reflect that Talwin in the strength of 50-milligrams, 50 tablets was prescribed. On January 9, 1981, the records reflect Talwin, 50-milligram strength, 40 tablets was prescribed. On January 19, 1981, the record reflects Talwin, 50-milligram strength, 40 tablets was prescribed. On February 2, 1981, a notation is given that the patient has injured his leg and had received a night appointment and has reported using all the Talwin due to intense pain. Further indication is that Talwin in the amount of 50-milligram strength, 10 tablets was prescribed. A second entry related to February 2, 1981, is made having to do with a visit in which Respondent examined Broughton. He found the leg on the right calf highly inflamed and two large hemotomas and that the patient was experiencing pain and for this condition, Talwin in the amount of 50-milligram strength, 50 tablets was prescribed. On February 11, 1981, a final notation indicates a refill of Talwin and the establishment of an appointment for the following day. That appointment was not kept. On February 16, 1981, the Talwin was ordered refilled. A notation was made at that time that the patient had not been keeping his appointments because of money owed and an expression of the importance to come in even if he could only pay a portion of the bill and a notation that the patient was using too much Talwin. All record notations are accepted as accurate depictions of events reported. Eventually, Broughton was picked up for criminal offenses related to controlled substances and was imprisoned. Unknown to Respondent, Broughton had given Talwin and Preludin which had been prescribed for him through Respondent to other persons. Following his release from incarceration, Respondent has refused to see Broughton. Although the records do not reflect the specific basis for prescribing Talwin in the questioned period, August 13, 1979, through February 16, 1981, other than the occasions of the hip and leg injury to his calf, it has been extrinsically established that Talwin was prescribed for pain related to a hernia condition, at times beginning December 31, 1979, and forward. There is other indication that the patient Broughton had sustained an injury to his coccyx and had some sacro coccygeal pain; however, it is unclear whether the Talwin was prescribed for that condition in the questioned period. Moreover, by May 20, 1980, Dr. Bonzon is expressing the opinion that physical examination of Broughton was negative regarding sacro coccygeal pain. The patient's records do indicate on March 11, 1977, complaints of Broughton with his tail bone or coccyx because of a fall in a Pantry Pride store in San Diego, California. On the subject of Broughton's involvement with drugs, in an interview held in November 1981, Respondent told John E. Danson, an investigator with the Department of Professional Regulation, that he thought Broughton was a drug addict because on one occasion, Broughton had offered him $50 to prescribe Dilaudid, a Schedule II controlled substance, at which time Broughton had been asked to leave Bonzon's office. Dr. Dunsford examined the records of treatment received by Broughton found in Petitioner's Exhibit E and gave the opinion that the amounts of Preludin and Talwin prescribed to Broughton in the time frame described were excessive and inappropriate. The prescription of those drugs over this period of time was not in the best interests of the patient according to Dr. Dunsford and not the actions of a reasonably prudent similar physician dealing with a patient under similar circumstances and conditions, on the subject of the skill and treatment afforded to this patient. As described by Dr. Dunsford, both Talwin and Preludin have addictive qualities. Dr. Dunsford did not feel that the pain the patient Broughton had experienced was sufficiently severe to warrant the number of Talwin tablets received. Continued response to the patient's request for more Talwin was in the words of Dr. Dunsford "bad." Dr. Dunsford also observed that the prescription of Preludin in November and December 1980, was not based upon any of the health conditions described in Section 458.331(1)(cc), Florida Statutes. The overall records of Dr. Bonzon related to the prescriptions of Talwin and Preludin, with particular emphasis on the December 11, 1980, prescription were deficient as it relates to a justification of continuing the regimen of prescribing these substances, according to Dr. Dunsford. The observations and opinions of Dr. Dunsford found in this paragraph are accepted. Dr. Ilano examined the records related to Broughton and did not find that Respondent's treatment was unacceptable. Likewise, Dr. Saylor did not find the treatment of Broughton to be unacceptable. The opinions by these doctors are not accepted. COUNTS XIV and XV Between July 1, 1980, and December 31, 1980, Respondent prescribed approximately 15,260 controlled substances constituted of Percodan, Percocet, Tuinal, Preludin, Tylox, Quaalude, Ritalin, Demerol, Merperganfortis, Biphetamine, Sopar, Eskatrol and Dilaudid. With the exception of these substances related to the patients Scheider, Knight, and Broughton, no notation has been made that these drugs were prescribed, dispensed or administered in excessive or inappropriate amounts i.e., the 15,000 number is not excessive and inappropriate "on its face," nor is this raw number an indication that Respondent has failed to practice medicine with a level of care, skill and treatment which is recognized by a reasonably prudent, similar physician as being acceptable under similar conditions and circumstances.
The Issue The issues are whether Respondent is guilty of: 1) failing to practice medicine within the applicable standard of care, as required by section 458.331(1)(t), Florida Statutes, by inappropriately and excessively prescribing one or more controlled substances and 2) failing to keep medical records that justify the course of treatment for prescribing one or more controlled substances, as required by section 458.331(1)(m), Florida Statutes, by failing to document patient histories, examination results, test results, results of drugs prescribed, dispensed or administered, or reports of consultations or hospitalizations, or failing to justify the amount and dosage of pills prescribed.
Findings Of Fact Introduction At all material times, Respondent has been a physician licensed to practice medicine in Florida. His license number is ME 33389. His practice is located in Delray. Respondent is not Board certified in any specialty. He appears to have practiced for many years. In 1987, Respondent was disciplined for a failure to keep medical records. The Board of Medicine reprimanded Respondent, imposed $2000 of costs and one year's probation, required 30 hours' coursework in risk management and recordkeeping, and restricted Respondent's license by requiring the submission of quarterly reports covering prescribing activities, among other things. In 2007, Respondent was disciplined for a violation of the requirements imposed on a dispensing practitioner. The Board of Medicine imposed a fine and probation. The Board also required a drug course, a law and rules course, ten hours' coursework in the responsibilities of dispensing practitioners and 25 hours' community service. This case involves Respondent's use of chronic opioid therapy for chronic and breakthrough pain not associated with cancer or other terminal disease. As detailed in the Conclusions of Law, the issues require consideration of whether Respondent's medical records are adequate to justify these prescriptions and whether these prescriptions are inappropriate, excessive, or otherwise unjustified, so as to violate the applicable standard of care. In attempting to prove these two sets of violations, Petitioner has limited its allegations to Respondent's prescriptions of five Schedule II controlled substances and one Schedule III controlled substance. The five Schedule II controlled substances are oxycodone, roxicodone, Oxycontin®, Oxyfast®, and Percocet®. The lone Schedule III controlled substance is Norco®. A Schedule II controlled substance has a high potential for abuse and has a currently accepted, but severely restricted, medical use in treatment in the United States. Abuse of a Schedule II controlled substance may lead to severe psychological or physical dependence. A Schedule III controlled substance has a lower potential for abuse and a currently accepted medical use in treatment in the United States. Abuse of a Schedule III controlled substance may lead to moderate or low physical dependence or high psychological dependence. People have used opium for pain relief for thousands of years. The pharmacological production of opioid drugs started after the identification of the morphine alkaloid in 1806. By the end of the 19th century, in the United States, legal controls were imposed on opioids. By the 1940s, opioids could be legally used only if prescribed by physicians, pursuant to strict regulatory controls. By the end of the 20th century, tension had emerged between physicians reluctant to prescribe opioids due to professional-liability considerations and advocates of pain control. Particularly contentious issues are whether and how to prescribe opioid therapy for chronic pain not associated with terminal disease. Oxycodone and hydrocodone are short-acting opioids with an onset of 30-90 minutes and duration of 4-6 hours. Roxicodone is oxycodone hydrochloride. In controlled-release form, such as Oxycontin®, oxycodone hydrochloride is a long-acting opioid with an onset of 1-12 hours and duration of 8-72 hours. With a quicker onset than oxycodone in pill form, Oxyfast® is a liquid containing 20 mg of oxycodone hydrochloride in a one-ml bottle. Percocet® is oxycodone and acetaminophen: a dosage of "10/325" is 10 mg of oxycodone and 325 mg of acetaminophen. Norco® is hydrocodone and acetaminophen: a dosage of "10/325" is 10 mg of hydrocodone and 325 mg of acetaminophen. Methadone is an inexpensive synthetic opioid with long- acting effect. The half-life of methadone typically ranges from 15-60 hours, but may extend to 120 hours. The long, variable half-life of Methadone discourages its wider use in pain control because of difficulties in maintaining not more than therapeutic levels. During the time in question, Oxycontin® was relatively expensive among the opioids listed in the preceding paragraph. At that time, one 30-mg roxicodone pill cost an uninsured patient about $0.70-$1.00, one 40-mg Oxycontin® pill cost an uninsured patient about $8.00, and one 80-mg Oxycontin® pill cost an uninsured patient about $14.00. The record does not reliably establish street values for these drugs, but all of them were traded and consumed at high rates illegally on the street. Short-acting opioids are more appropriate for breakthrough pain, which is a temporary spike in pain above chronic-pain levels due, for example, to physical exertion. A short-acting opioid is well-matched to the relatively short duration of breakthrough pain. This record does not permit resolution of the dispute over whether long-acting opioids are more effective than short-acting opioids for the relief of chronic pain. Generally, prescribed opioids pose distinct risks of consumption and diversion by the patient. For the opiate-naïve patient, doses of opioids that may be easily tolerated by the opiate-tolerant patient may cause potentially life-threatening side effects, including respiratory depression. For the opioid- tolerant patient who is consuming opioids not prescribed by the practitioner--from other, undisclosed practitioners or from street purchases--additional doses of prescribed opioids may cause the same life-threatening side effects as those faced by the opiate-naïve patient, although, with controlled dosing among opioid-tolerant patients, opioids typically may be increased until pain control is attained. Pain medicine practitioners may manage these risks, in part, by administering periodic urinalyses to their patients. The urinalyses administered to the ten patients in this case were threshold tests that would detect the presence of various substances above a certain level. Such tests would uncover opioid-naïve patients and patients consuming other controlled substances, but not the level of any controlled substance detected by the test. Sometimes, opioid rotation may achieve the desired analgesic effect at relatively low doses. Otherwise, chronic pain may require increasing doses of the same opioid to obtain the same relief originally obtained by lower doses, although some patients may find effective relief for extended periods at a dosing level that is not increased. Less frequently, higher opioid doses may produce hyperalgesia. Optimally, effective pain management is multifaceted, including such disciplines or techniques as psychotherapy, cognitive behavioral therapy, biofeedback, relaxation techniques, physical therapy, and reliance on nonopioid analgesics. But limits on insurance coverage or lack of insurance and the relatively high costs of most of these alternative disciplines or techniques may legitimately require the practitioner to rely more on the relatively inexpensive opioids. Even Petitioner's expert witness admitted, "Sometimes I have self-pay patients who are on opiates only because they can't afford anything else." (Pet. Ex. 4, p. 7.) Petitioner's expert acknowledged that roxicodone "is something you tend to give people who have no insurance." (Tr., p. 85.) Cost considerations may also require that the practitioner break down what would be a single prescription of, say, 100 pills into two prescriptions of 50 pills each, so the patient can effectively pay for his prescription in two installments. Again, Petitioner's expert witness admitted that there was nothing wrong with this practice. (Pet. Ex. 4. p. 41.) None of the ten patients addressed in this case had insurance during the relevant period. (One patient potentially had COBRA coverage that would have expired long before the period in question.) Although at least a couple of patients were employed in professions in which at least moderate earnings might be expected, the record does not reliably describe the financial resources of any of the ten patients. The record contains no evidence of injury to the patients discussed below in terms of the care, including prescribed opioids, that they received from Respondent. Excessive consumption of prescribed or diverted opioids is dangerous and can be fatal. But, as Respondent's expert witness testified, the fatal combination seen "excessively" in the eight deaths per day in Florida from prescription drug abuse is opioids; benzodiazepines, such as Xanax®; and muscle relaxants, such as Soma®. Although Respondent prescribed medications in all three categories, Petitioner has not alleged any violations arising from Respondent's prescriptions of any drug besides the opioids discussed above, so Respondent's prescriptions of benzodiazepines and muscle relaxants to these ten patients are generally omitted from the Findings of Fact. As Petitioner's expert testified, there is no quantitative criterion for the standard of care in prescribing opioids. (Tr., pp. 29 and 108.) The standard-of-care determination is dependent on the facts. Two facts of importance are the achievement of pain relief and the restoration or maintenance of function in the patient. The record contains ample evidence of the extent of pain relief, although nearly all of it is in the form of reports from patients, whose credibility is difficult to assess. The record contains relatively little evidence of functionality for most patients. As discussed in the Conclusions of Law, contrary to the testimony of Petitioner's expert, a standard-of-care violation is not established, per se, by a medical-records violation. The record is problematic in several other respects. Most notably: 1) Petitioner's expert witness stated in his initial report to Petitioner that Respondent's medical records were adequate and justified the course of treatment (Tr., pp. 111-22); but 2) Respondent's expert witness stated that Respondent's medical records were inadequate, at least based on present practices. (Depo. Tr., Forest S. Tennant, Jr., pp. 51- 52.) Also, in what probably came as a surprise to Petitioner, its expert witness three times opined that, under certain conditions, a physician may lawfully deviate from the applicable standard of care in the prescription of opioids. (Tr., pp. 65, 90, and 95-96.) The testimony of each expert witness was uneven. Most of the flaws of Petitioner's expert are listed above, but he repeatedly tended to agree with the attorney asking him questions. Neither expert displayed an over-familiarity with the details of the medical records; sometimes, Respondent seemed somewhat unfamiliar with them too. Petitioner's expert is Board certified in the subspecialty of pain medicine and practices in Orlando; Respondent's expert is not Board certified in any specialty or subspecialty and has never practiced in Florida. But Respondent's expert thoughtfully explained how a higher blood pressure and pulse rate might be associated with under- medication, and a lower blood pressure and pulse rate might be associated with over-medication. Respondent's expert also recognized the difference between a medical-records violation and a standard-of-care violation. During the time in question, Respondent saw 15 patients daily, not 60 or more patients daily, as are seen by some high-volume opioid-prescribing physicians. The ten patients in this case are all residents of Florida, not residents of other states drawn to the opioid-prescribing practices of a compliant Florida physician. (One of the ten patients appears to have been a resident of Mississippi, but had a Florida driver license--tending dispel an inference that he was in Florida briefly for the purpose of obtaining opioids.) Almost always, Respondent obtained patient records from the physician who had been treating the patient immediately before he or she began seeing Respondent. And, at a time when the practice was not required by statute or rule, Respondent used urine screens to determine whether his patients were consuming the opioids that he was prescribing them. For none of the ten patients has adherence to the dosing practice of a preceding physician, per se, constituted compliance with the applicable standard of care. Except for a relatively brief period after acquiring the patient, Respondent could only satisfy the applicable standard of care by appropriate treatment, regardless of the dosing practice of the preceding physician. In large part, the purpose of administering urinalyses was to detect aberrant behavior by the patient. In this context, aberrant behavior means patient diversion of opioids or consumption of other opioids or other controlled substances without disclosure to Respondent or, in the case of illegal consumption of such substances, even with disclosure to Respondent. W. C. From February 12, 2007, through July 16, 2009, Respondent prescribed to W. C. 150 30-mg roxicodone pills and 120 15-mg roxicodone pills each month. Respondent first saw W. C. on June 20, 2001, when Respondent served as the medical director of the Pain Management Center in Miami. At the time of this initial visit, according to Respondent's medical records, Respondent complained of rheumatorial arthritis of the left knee, on which he had had surgery, two years earlier, to repair a tear of the medial collateral ligament. W. C. also complained of lower back pain and tendonitis in the left elbow and shoulder. The patient's situation was exacerbated by his job, which involved moving refrigerators. The initial note states that the patient's general practitioner, Dr. Martin Coleman, had prescribed him 5-mg pills of Roxicet®, and the patient had taken some Xanax® from his wife to relieve spasms and stress. The next office visit took place on July 16, 2001, at which time Respondent brought a "note," not medical records, from Dr. Coleman. According to Respondent's medical records, Dr. Coleman's note stated that the degenerative arthritis was of the right knee, not the left knee, which had been treated with Percocet®, which is similar to Roxicet®. Evidently relying on the patient's statement that he had tried his wife's Xanax®, the July 16 record states: "His anxiety is helped tremendously with Xanax®." At this time, Respondent saw W. C. for seven or eight months. These medical records are missing, but they are not at issue in this case. At some point, W. C. transferred to the Delray office of the Pain Management Center while this office was staffed by Drs. Morency, Rabinsky, and Weed. In November 2005, W. C. suffered a wedge fracture of the T12 vertebra, which caused him severe back pain, as a result of an automobile accident. On February 14, 2007, Respondent saw W. C. in the Delray office of the Pain Management Center, to which Respondent had since transferred. Among the records that Respondent reviewed was a neurological consultation dated September 7, 2006, in which the neurologist, Dr. Perry Hoeltzell, described cervical, left arm, left lower back, and left leg complaints since the November 2005 accident. Respondent also examined an MRI of the spine taken on September 7, 2006, that showed a T12/L1 collapse of the disc with chronic anterior wedging of the T12 vertebra. The appearance was of a flexion trauma. These conditions supported the finding or complaint of cervical radiculopathy of C3 through C6 and lumbar radiculopathy of L4-5/L5-6. W. C. informed Respondent that he liked the flexibility of his current prescription of 150 pills of 30-mg roxicodone and 120 pills of 15-mg roxicodone monthly, so he could decide which dose to take when. However, W. C. did not appear to be an uncritical consumer of every controlled substance that he could get. The July 16, 2009, medical note reports that W. C. declined a renewal of Cymbalta®, saying that it did not work and, "I didn't think I needed it." At the time of the February 14, 2007, office visit and through the final office visit of July 16, 2009, W. C. was able to work and suffered no side effects. Each month, Respondent saw W. C. in the office and typically spent 15-30 minutes talking with him. The medical records over this period are inadequate and do not justify the opioid prescriptions that Respondent gave W. C. during this time. For two and one-half years, Respondent prescribed the same two prescriptions of roxicodone with medical records consisting of monthly reports of blood pressure, pulse, general appearance, patient history, and complaints, such as level of pain, the extent of pain relief, side effects, sleep, and mood. As tended to be his practice with all ten patients, Respondent never filled in the bottom of the medical-record form, which prompted insertion of the "plan." Respondent never recorded any diagnosis or general assessment of W. C., or recorded how he was managing the patient. For over two and one-half years, Respondent failed to document these important elements of medical records. This was too long for Respondent to claim that he was merely maintaining the prescription regime of the preceding physician until Respondent had the opportunity to assess the patient, discuss with the patient treatment alternatives, and develop a pain- management plan. In this timeframe, Respondent should have documented these tasks multiple times. The absence of this critical patient assessment and treatment information from the medical records means that the records fail to justify the course of treatment. Petitioner's expert witness opined that Respondent violated the applicable standard of care due to the excessive prescription of medications. But when asked why the prescribed medications were excessive, the expert responded, "the medical records," which, he explained, failed to provide an understanding of how the patient was managed, failed to provide a diagnosis, assessment, or treatment plan, and omitted any description of level of functioning, clinical exams, or physical exams. (Tr., p. 23.) Petitioner's expert witness described Respondent's medical records as "poor." (Tr., p. 27.) If there were any doubt that the basis of the expert's standard-of-care opinion was the inadequate medical records, he dispelled it in the following exchange: Q: Dr. Gerber, this prescribing of roxicodone 30 mg of 150 pills in conjunction with roxicodone 15 mg of 120 pills, what is your opinion about the appropriateness and whether or not the prescribing of those two--that combination is within the standard of care and why? A: Well, without medical records justifying it, if falls below the standard of care. There's no explanation of why these two potent opioids are being prescribed together. . . . (Tr., pp. 24-25.) Obviously, where the patients, other than W. C., do not testify, the ability of Petitioner's expert to opine as to the standard of care is limited to what he has learned of their care from the medical records and the testimony of Respondent, which supplies very little in addition to what is contained in the medical records. After an extensive discussion of the inadequacies of the medical records, in response to a standard- of-care question, the expert admitted that the lack of medical records left him "not able to formulate an opinion as to how this patient was managed." (Tr., p. 23.) Immediately after this statement, Petitioner's expert twice testified that the standard-of-care violation was due to the problems with the medical records. (Tr., pp. 23-24.) The frustration of Petitioner's expert witness, although understandable, does not justify elevating a medical-records violation to a standard-of- care violation--again, as explained in the Conclusions of Law. The sole attempt of Petitioner's expert to predicate a standard-of-care violation on something besides the inadequate medical records was unsuccessful. Although he elsewhere disclaimed reliance merely on the quantity of prescribed opioids as the sole basis of a standard-of-care violation, Petitioner's expert complained about Respondent's prescription of "these two potent opioids . . . together." (Tr., p. 25.) Of course, there is only one potent opioid at issue in the W. C. counts-- roxicodone. (Xanax®, which Respondent also prescribed to W. C., is not an opioid and, as noted above, is not alleged as a basis of any liability in this case.) If the two opioids were the two dosages of roxicodone, the expert's complaint appears to be a back-door attempt to object to the quantity of prescribed opioids--in isolation from other relevant factors. Significantly, Petitioner's expert testified that, with acceptable documentation, "one [of the roxicodone prescriptions] by [itself] might be acceptable" (Tr., p. 25)--implying that his underlying problem is with the quantity of this opioid that Respondent has prescribed. But, as Petitioner's expert witness conceded, "patients can have a lot of pain and require high doses of opioids even with minimal diagnostic studies." (Tr., p. 26.) Petitioner's expert eventually admitted that a monthly prescription of 120 pills of a hypothetical 45-mg roxicodone, which is slightly less than Respondent's prescription of 120 pills of 15-mg roxicodone and 150 pills of 30-mg roxicodone, might have met the standard of care, if "there was good documentation of physical functioning [and] the notes and records clearly documented an assessment and plan." (Tr., p. 31). For W. C., clinical reports amply documented injuries that could have accounted for the pain that W. C. consistently reported during the period in question. The record establishes sustained function during the course of treatment--and even beyond. Alone among the patients, W. C. testified to his extensive orthopedic problems in his back and to the role of Respondent and his medication regime in preserving W. C.'s functionality. Respondent's treatment of W. C. left one question unanswered. In general, Petitioner's expert rightly asked why Respondent did not offer or explore nonopioid treatments. (Tr., p. 27.) The absence of any consideration of nonopioid treatments is a deficiency in the medical records, but also relevant in determining whether Respondent met the standard of care. Respondent's usual explanation--the prohibitive costs of such alternative treatments--may not apply to W. C., who was continuously employed throughout his treatment, possibly even as the owner of the company for which he worked. Respondent testified: "He was a laborer, he had his own moving company." (Tr., p. 209.) But, standing alone, this question does not establish a standard-of-care violation. There is less, if any, value in the suggestion of Petitioner's expert that a standard-of-care violation may be based on Respondent's failure to prescribe methadone. As noted above, this record fails to establish that the standard of care requires the use of long-acting opioids for chronic pain, and this repeated suggestion by Petitioner's expert fails to account for the difficulties, noted above, in the use of this persistent opioid, which even Petitioner's expert admitted must be used "carefully." (Tr., p. 32.) Petitioner proved a medical-records violation, but not a standard-of-care violation. D. M. From January 8, 2007, through July 18, 2007, Respondent prescribed to D. M. a monthly regime of roxicodone and Oxycontin®. The sole exception to the monthly office visits with Respondent is an office visit dated February 5, 2007, which, judging from the handwriting on the note, involved another physician at the Pain Management Center. Respondent's prescriptions for January 8 and March 5 were for 100 30-mg roxicodone pills and 180 40-mg Oxycontin® pills. On April 2, Respondent increased the monthly prescription to 180 30-mg roxicodone pills while maintaining the number and dose of Oxycontin® pills. On April 30, Respondent increased the number of roxicodone pills to 200 monthly, but decreased the dosage to 15 mg, while maintaining the number and dose of Oxycontin® pills. On May 24, Respondent issued a prescription for 200 15-mg roxicodone pills, 100 30-mg roxicodone pills, and 180 40-mg Oxycontin® pills. On June 21, Respondent prescribed 200 15-mg roxicodone pills and 180 40-mg Oxycontin® pills. On July 18, Respondent prescribed 100 30-mg roxicodone pills and 180 40-mg Oxycontin® pills. D. M. is unique among the ten patients in two regards. She has the shortest treatment period at six months, and she is the only patient to have received Oxycontin® monthly for the duration of her treatment under Respondent. Another unusual aspect of D. M.'s case is Respondent's clear confusion about his treatment of her. Respondent testified that he first saw her on May 24, 2007. This testimony is contrary to the stipulation, and it is not borne out by the medical records. The medical notes for January 8 (Joint Ex. 2, p. 159), March 5 (Joint Ex. 2, p. 157), April 2 (Joint Ex. 2, p. 156), and April 30 (Joint Ex. 2, p. 155) all appear to be in the handwriting of the physician who filled out the medical note for May 24 (Joint Ex. 2, p. 346). D. M. bore a diagnosis of fibromyalgia, which is a diagnosis of a condition whose existence divides the medical community. However, associated with the diagnosis is widespread pain involving the muscles and soft tissues and sleep disturbances, both of which D. M. reported. Although the disease is not like a fracture or herniated disc in its ability to be confirmed by some form of imaging technology, the present record provides an inadequate basis to disregard the existence of this condition or dismiss the potential severity of the pain associated with this condition. In 1995, D. M.'s physician, Thomas Fitzpatrick, M.D., referred D. M. to John H. Gridley, Jr., M.D., who specialized in internal medicine and rheumatology. After an examination of this 35-year-old patient, Dr. Gridley diagnosed D. M. with what is now referred to as fibromyalgia. She has borne this diagnosis ever since. D. M. had been a patient of the Kendall office of the Pain Management Center since 2003. Her condition had deteriorated since 1995; she had spent two years in bed. During this time, she had received the opioids that Respondent later maintained. When D. M. first saw Respondent nearly 12 years later, she had gained 70 pounds, and her systolic blood pressure had increased 34 mm to 144/72. D. M. advised Respondent that the only medication that relieved her pain was Oxycontin®, so, after discussing diet and exercise, Respondent continued her existing prescription of Oxycontin® with roxicodone for breakthrough pain. On D. M.'s next visit, on March 5, no vital signs were taken. On her next visit, on April 2, her blood pressure had dropped to 102/78, although her pulse was 78. Her pain, which was reported as "6" on her first visit, was down to "5" on this visit. In addition to his confusion over when he started treating D. M., Respondent seemed confused by his own treatment plan for this patient. Alluding to his much-used explanation of financial constraints precluding the prescription of Oxycontin®, Respondent testified that, due to "financial reasons," "we converted one Oxycontin® to Roxy 30s, giving her exactly the same dosage. The patient was having financial problems. I remember that." (Tr., p. 227.) However, the record reveals no reduction in the relatively expensive Oxycontin® prescription, only an increase in the roxicodone prescription on April 30 and again on May 24. Later, Respondent testified that his office mistakenly increased the roxicodone prescription on April 30 from "100 to 180 milligrams." (Tr., p. 228.) However, this increase amounted to only 20 30-mg pills for the month or about 20 mg daily. The increase on May 24 was much larger--from 6000 mg/month of roxicodone to 9000 mg/month of roxicodone. This was also a mistake, but a much bigger one. D. M. never informed Respondent of the prescription error, which Respondent "didn't like." (Tr., p. 228.) Respondent reduced the June 21 prescription, probably to allow D. M. to use some of the extra roxicodone that she had on hand. (Tr., p. 228.) However, Respondent never attempted to explain how these two dosing mistakes happened or, if they were not mistakes, what justified these dramatic increases in opioids being prescribed to the patient. Respondent probably did not attempt a justification of these increased dosages because no justification existed: D. M. reported a small increase in pain from April 30 to May 24, but only from a "5" to a "6." Consistent with his refusal to predicate a standard- of-care violation strictly on the quantity of opioids prescribed, Petitioner's expert witness admitted, "counting pills is not the best way of managing a patient." (Tr., p. 43.) But his standard-of-care analysis regarding Respondent's care for D. M. includes the quantity of pills in the context of patient complaints, the underlying diagnosis, and the existence of alternative means of treating the patient's pain, such as a fentanyl patch. (Tr., pp. 40 and 45.) The standard-of-care violation for D. M. relies on this broader record of Respondent's care for this patient, not on the following testimony of Petitioner's expert: "So, the whole case boils down to, you shouldn't be putting patients with fibromyalgia on this much medication." (Tr., p. 44.) Neither in May 2007 nor three and one-half years later at the hearing did Respondent have any idea why he dramatically increased D. M.'s roxicodone prescription on May 24. To the extent that Respondent claimed a "mere" mistake, his explanation would have carried more weight, if he had not also offered his well-worn financial argument that the patient could not afford the additional cost of the long-acting opioid, Oxycontin®. This argument did not apply to D. M., who was already paying for Oxycontin® each month. This makeshift defense, the unjustified increase of opioids, the mistaken recollection of the substitution of roxicodone for Oxycontin®, and the failure to recall when Respondent's treatment of this patient started combine to make Respondent's brief treatment of D. M. appear random and chaotic. On these facts, Respondent's prescription of opioids was inappropriate, excessive, and otherwise unjustified. Petitioner proved a medical-records violation and a standard-of-care violation. R. H. From January 29, 2007, through July 7, 2009, Respondent prescribed to R. H. a monthly regime of 30-mg roxicodone and 10/235 Norco®. For January 29 and March 2, the dosages were 60 roxicodone pills and 240 Norco® pills. On March 27, Respondent raised the roxicodone prescription to 90 pills. This prescription continued through visits on April 24, May 22, June 20, and July 18. On August 2, which was only two weeks after the preceding office visit, Respondent doubled the number of roxicodone pills to 180. On September 28, Respondent increased the roxicodone by one-third, from 180 to 240 pills. On November 30, Respondent increased the roxicodone prescription to 300 roxicodone pills and, for the first time, changed the Norco® prescription, raising it from 240 pills to 300 pills. Respondent maintained these prescriptions through 14 "monthly" visits in 2008--actually, 13, as the last is on December 23, 2008--and visits on January 21 and February 17, 2009. On March 17, Respondent decreased the Norco® to 280 pills. On the final visit, on July 7, 2009, Respondent decreased the roxicodone to 270 pills and Norco® to 240 pills. Respondent first saw R. H. in 2001 due to failed-back syndrome following a car accident three or four years earlier and a micro-discectomy of L5/S1, which had resulted in additional complications. R. H. had been wheelchair-bound for eight months and was learning to walk again; she was in intractable pain. A psychiatrist later diagnosed her with severe anxiety disorder and post-traumatic stress disorder. R. H. visited the Pain Management Center after a referral by her physician, who was no longer comfortable prescribing her Vicodin ES®. R. H. disclosed in her 2001 initial office visit that she had recently had another automobile accident, for which she had been charged for driving under the influence. R. H. reported that epidural injections had failed to control her pain, and she had gained 50 pounds in the past couple of years. An unsettling consultation note is in R. H.'s medical records. On January 31, 2001, Anjan K. Ghosh, M.D., of the Anesthesia Pain Care Consultants, Inc., saw R. H. in consultation. Dr. Ghosh concluded the R. H. suffered from lumbar post-laminectomy pain syndrome "with conflicting physical signs on examination," mechanical lumbar axial pain, severe anxiety disorder, and gastroesophagael reflux disease. In a detailed plan of treatment, Dr. Ghosh proposed a caudal catheter neuroplasty and nerve root decompression to treat R. H.'s recurrent lumbar radiculitis. Based evidently in part on an adverse surgical experience, R. H. refused this treatment, saying, "the reason I was sent to see you [was] for only pain medication." After Dr. Ghosh explained that he would continue her Vicodin ES® only for two weeks, R. H. asked again if she could consider the surgical intervention later, but, for now, obtain prescriptions for an opioid regimen, which Dr. Ghosh declined to do. R. H. was an unusual patient because, even though she was in her mid-thirties when she first saw Respondent, she often brought her mother, who, according to Respondent, "doled" out her prescribed opioids. (Tr., p. 242.) In contradictory statements, Respondent testified: "She did well. She was able to function. She lost jobs constantly." (Tr., p. 243.) Respondent's testimony about this patient is surprisingly brief based on the lengthy two and one-half years that he saw her, as covered by this case; the dramatic increase in roxicodone from 1800 mg monthly to 9000 mg monthly, with a smaller increase in Norco®; and the instability of the patient, as reflected by her dogged pursuit of opioids, her DUI arrest five or six years earlier, and the role of her mother as the gatekeeper to her prescribed opioids. Petitioner's expert witness noted that the March 27, 2007, medical note, in which Respondent raised the roxicodone from 60 pills to 90 pills monthly, contained no explanation for the increase. Likewise, Petitioner's expert found no justification in the medical records for the doubling of the roxicodone from 90 pills to 180 pills monthly in August 2007, the increase from 180 pills to 240 pills monthly two months later, or the increase of the Norco® from 240 pills to 300 pills monthly one month later. Petitioner's expert noted these increases in opioids were not accompanied by physical exams, physical findings, or any consideration of alternative therapies, such as nonsteroidal anti-inflammatory drugs. Respondent's medical records reveal a "4" for reported pain on March 1, 2007, but no vitals, and no pain report or vitals on March 27, 2007, when Respondent hiked the roxicodone by 50% and prescribed Neurontin®, which Respondent testified at the hearing he did not "even know what it is." (Tr., p. 240- 41.) The medical note for April 24, 2007, consists of a few scribbled lines without any vitals or pain report. On May 22 and June 20, 2007, the medical records contain vitals, but no pain report. Finally, on July 18, the medical note contains a pain report, but it is still a "4." Two weeks later, when Respondent doubled the roxicodone from 90 to 180 pills monthly, the medical note reflects that the pain is still only a "4." During this period of time, R. H. had had a molar surgically removed on April 7, 2007, and had been passing out weekly since that event. In mid-September 2007, R. H. was admitted to a local hospital one week after an automobile accident. In the followup to the automobile accident, a CT scan of the brain revealed vascular abnormality, which required a followup hospital admission that did not reveal anything especially serious. However, the accident had resulted in some upper extremity pain and some back pain. At the time of the hospital admission in connection with this accident, R. H. admitted only to the use of Soma® and Valium®, as well as occasional marijuana, but not the extensive opioids that Respondent was prescribing. All of this information is in Respondent's medical records. R. H. reported a pain level of "8" on the September 28 medical note, despite the large increase in roxicodone prescribed two months earlier. If there was a discussion of the recent automobile accident, it does not emerge from the nearly illegible notes, and Respondent did not testify to any analysis of the effect of this recent accident. At this time, Respondent increased the roxicodone by 50%--from 180 pills to 240 pills monthly. On November 1, 2007, the medical note reveals that R. H. reported pain at a level of "5." On a patient questionnaire, R. H. reported that pain had not interfered at all in the past month with her mood, walking, sleeping, concentrating, appetite, work, or relationships, and she denied any side effects. Despite this information, one month later, on November 30, with the pain reported at only a "4," Respondent increased the roxicodone by 60 pills monthly. While Respondent maintained this prescription through 2008, R. H. reported pain at only a "4." On February 17, 2009, in a medical review, Respondent noted that R. H.'s urine had tested positive for THC. This note records R. H.'s difficulty in keeping a job. This note describes a treatment plan to continue the present pain medications, possibly taper benzodiazepines, and continue to refer R. H. to psychotherapy. There is little connection between the medical records--most notably, the self-reported pain levels--and the amount of opioids that Respondent prescribed. Given the obvious difficulties that this patient was experiencing and the large increases in opioids that Respondent prescribed her, the treatment plan described in the preceding paragraph was insufficient. These facts do not depict merely a failure of the medical records to justify the course of treatment. Even without regard to the single indication of marijuana use, R. H. was a substance abuser who lied to health-care providers about what she was taking and required her mother to control her access to the opioids that Respondent prescribed. Respondent's treatment "plan" was to give R. H. exactly what she wanted, including one drug with which Respondent was completely unfamiliar. This patient needed help, and Respondent, for two and one-half years, failed to practice in accordance with the applicable standard of care by continuing to supply her with an increasing supply of opioids--essentially, failing to treat her. Under these circumstances, Respondent's opioid prescriptions were inappropriate, excessive, and otherwise unjustified. Petitioner proved a medical-records violation and a standard-of-care violation. K. L. From March 15, 2007, through July 16, 2009, Respondent prescribed to K. L. a monthly regime of mostly 30-mg roxicodone with occasional 10/325 Percocet®, 80-mg Oxycontin®, and 15-mg roxicodone. On March 15, 2007, Respondent prescribed 420 30-mg roxicodone pills (all roxicodone prescriptions for K. L. are for 30 mg unless otherwise stated) and 120 Percocet® pills. This prescription continued through office visits on April 11, May 9, and June 6, at which time Respondent dropped the Percocet® prescription. From July 2, 2007, through November 14, 2007, which covers five and one-half months, Respondent prescribed "monthly"--on six occasions--420 pills of roxicodone. On December 12, 2007, Respondent reduced the prescription to 400 pills of roxicodone, but added 60 Percocet® pills. This prescription continued through office visits on January 8, 2008, and February 7. On March 5, 2008, Respondent dropped the Percocet® from the prescription, but raised the roxicodone to 420 pills. This prescription continued until January 5, 2009--so as to cover 11 months with 12 "monthly" prescriptions. On January 30, 2009, Respondent reduced the roxicodone from 420 pills to 360 pills. On February 26, 2009, Respondent effectively increased the prescription by reducing the 30-mg roxicodone from 360 pills to 280 pills, but adding 200 pills of 15-mg roxicodone. On March 5 and 6, 2009, Respondent prescribed 90 roxicodone pills, 30 Percocet® pills, and 26 Oxycontin® pills (in two prescriptions). Four days later, on March 10, Respondent prescribed 120 roxicodone pills. Fifteen days later, on March 26, Respondent prescribed 390 roxicodone pills. On April 22, Respondent prescribed 360 roxicodone pills. On May 20, he prescribed 330 roxicodone pills. And on June 17 and July 16, 2009, Respondent prescribed 300 roxicodone pills each office visit. At the initial visit, K. L. informed Respondent that he had been seeing another pain physician, Frederick Swartz, M.D., but was required to visit every three weeks and found the office hours inconvenient. One may safely infer that the frequency of visits was part of Dr. Swartz's attempt to restrict K. L.'s aberrant behavior. Dr. Swartz had prescribed, every three weeks, 84 Percocet®, 284 roxicodone, and 84 Xanax®. On a monthly basis, the 84 pills translate to about 121 pills, and the 284 pills translate to about 410 pills. Respondent's initial prescription thus maintained the levels of Percocet® and roxicodone that the preceding physician had prescribed. During the initial interview, K. L. advised Respondent that he had suffered orthopedic injuries from being struck in the face with a baseball bat many years earlier, as well as two automobile accidents more recently. Having previously worked as a personal trainer, according to the notes, K. L. "works now in the New York State Business." The meaning of this statement remains known only to its author, but does not necessarily mean that K. L. was an out-of-state patient. K. L. informed Respondent that he obtained adequate pain relief from the 14 roxicodone that he took daily. K. L. stated that he had tried Oxycontin® for a couple of days, but did not like it due to cognitive impairment. His only surgical history involved the repair of the eye socket following the baseball bat injury. K. L. rated his pain as a "6." Respondent testified that, after four months, he eliminated the Percocet® because there was no need for K. L. to be taking two short-acting opioids simultaneously, and Respondent was concerned about potential acetaminophen toxicity. These were prudent concerns. A major issue in this patient's treatment developed when, on March 15, 2007, he took a urinalysis, and it tested positive for opiates, in addition to the oxycodone and benzodiazepine that Respondent had been taking, as prescribed. The test results distinguish between the oxycodone present in the roxicodone and Percocet® that had been prescribed for K. L., and other, nonprescribed opiates, such as heroin and codeine. K. L. failed subsequent urinalyses administered by Respondent. On May 9, 2007, his urine tested positive for oxycodone and other opiates, but not benzodiazepines. On February 7, 2008, January 30, 2009, and February 26, 2009, K. L.'s urine tested positive for oxycodone, morphine (another opiate that evidently is disclosed separately from opiates), and benzodiazepines. Respondent's contradictory testimony confirms his mishandling of the patient. Initially, Respondent testified that he had concluded, when K. L.'s urinalyses first disclosed opiates, that K. L. suffered from some sort of rare condition in which the liver failed to metabolize the oxycodone and caused the urinalyses to detect the oxycodone as other opiates. This explanation is discredited because Respondent failed to order additional lab work on liver function at the time and failed generally to proceed to rule out or otherwise deal with any liver problems. Respondent later admitted, in cross- examination, that he was not concerned about K. L.'s liver in 2007 (Tr., p. 339.), but only became concerned about it in 2009. (Tr., p. 340.) The actual explanation for the failed urinalyses was K. L.'s consumption of other opiates that he was not disclosing to Respondent. And Respondent was aware of this aberrant behavior. Undermining his testimony about a later suspicion of liver dysfunction, Respondent, reading from a medical note dated January 30, 2009, testified: "I even put [K. L.] on probation because I thought he was lying to me." Obviously, he would not have put a patient on probation for impaired liver function. Even if Respondent were telling the truth that he did not realize, until January 30, 2009, that K. L. had been lying to him about other opiate use--which he was not--two facts nonetheless undermine Respondent's attempted explanations. First, from March 15, 2007, through January 30, 2009, Respondent prescribed to K. L. over 10,000 roxicodone pills. After Respondent claimed to have concluded that K. L. was lying about other opiate use, Respondent prescribed, from February 26, 2009, through July 16, 2009, over 2000 more roxicodone pills plus 200 15-mg roxicodone pills. As was the case with R. H., these facts do not depict merely a failure of the medical records to justify the course of treatment. K. L. is also a substance abuser, engaging in the especially dangerous behavior of combining his prescribed opioids with unprescribed opioids. For almost two years, Respondent joined K. L. in an elaborate rationalization process designed to avoid confronting the patient's urgent problem. K. L. needed help, and Respondent, for two years, failed to practice in accordance with the applicable standard of care by continuing to supply him with an increasing supply of opioids-- essentially, failing to treat him. Under these circumstances, Respondent's opioid prescriptions were inappropriate, excessive, and otherwise unjustified. Petitioner proved a medical-records violation and a standard-of-care violation. J. K. From May 22, 2007, through July 27, 2009, Respondent prescribed to J. K. a monthly regime of 30-mg roxicodone plus Oxyfast® occasionally. (All roxicodone prescriptions for J. K. are for 30 mg.) On May 22, 2007, Respondent provided J. K. with two prescriptions of 120 roxicodone pills each. On June 19, Respondent wrote J. K. two roxicodone prescriptions--one for 150 pills and one for 170 pills. On July 16, Respondent wrote J. K. a prescription for 150 roxicodone pills, a prescription for 120 roxicodone pills, and one bottle of Oxyfast®. On August 13, Respondent wrote J. K. a prescription for 300 roxicodone pills, five roxicodone pills, and two bottles of Oxyfast®. On September 10, Respondent wrote J. K. a prescriptions for 295 roxicodone pills, five roxicodone pills, and one bottle of Oxyfast®. On October 8, Respondent reduced the numbers of roxicodone pills by giving J. K. prescriptions for 190 roxicodone pills, 140 roxicodone pills, ten roxicodone pills, and one bottle of Oxyfast®. On November 2, Respondent maintained these prescriptions, dropping only the prescription for ten roxicodone pills. But, three days later, Respondent gave J. K. a prescription for ten roxicodone pills. On December 3, 2007, Respondent greatly increased the prescription, raising it to 410 roxicodone pills and two bottles of Oxyfast®. On January 4, 2008, Respondent reduced the prescription to 330 roxicodone pills in one prescription and ten roxicodone pills in the other, as well as two bottles of Oxyfast®. Again, on February 1, 2008, Respondent increased the prescription, raising it to 380 roxicodone pills, but dropping the Oxyfast®. Respondent repeated this prescription on February 28 and raised it to 410 roxicodone pills on March 28. Respondent lowered it to 380 roxicodone pills on May 22. Then, on May 22, June 19, July 17, and August 13, Respondent prescribed 450 roxicodone pills each month. Respondent did not see J. K. for the next five months. On January 19, 2009, Respondent gave J. K. separate prescriptions of 200 and 250 roxicodone pills. On February 13, Respondent issued J. K. a single prescription for 450 roxicodone pills. On March 12, Respondent issued five roxicodone prescriptions for 200 pills, 100 pills, 100 pills, 50 pills, and 70 pills--for a total of 520 pills. Six days later, on March 18, Respondent gave J. K. another roxicodone prescription--this time for 30 pills. On April 7, Respondent gave J. K. two roxicodone prescriptions--one for 100 pills and one for 250 pills. Six days later, on April 13, Respondent gave J. K. two more roxicodone prescriptions--one for 200 pills and one for 50 pills. On May 5, Respondent gave J. K. a roxicodone prescription for 250 pills. On June 1, Respondent gave J. K. roxicodone prescriptions for 250 and 200 pills each. And on June 29 and July 27, Respondent gave J. K. roxicodone prescriptions for 450 pills each. J. K. had been a semi-professional hockey player who retired prematurely due to back pain. He exacerbated his back problems when he was involved in an automobile accident on April 19, 2004. On July 16, 2007, J. K. reported a pain level of "7," but this increased to a "9" on August 13, 2007. At this time, Respondent increased the roxicodone prescription. However, the medical records do not reveal escalating pain reports during the first half of 2008 when Respondent twice ramped up the roxicodone levels. The complaints of Petitioner's expert witness are that Respondent prescribed short-acting opioids for chronic pain, and Respondent prescribed excessive opioids for the injury at issue, which Petitioner's expert first identified as the older hockey injury, not the newer injury from the car wreck. These complaints appear ungrounded. As noted above, this record fails to reveal the superiority of long-acting opioids over short-acting opioids for the treatment of chronic pain, and Petitioner's expert acknowledged that a practitioner must sometimes prescribe roxicodone, rather than a long-acting opioid, such as Oxycontin®, due to cost considerations. Obviously, in suggesting that J. K.'s pain was disproportionate to his injury, Petitioner's expert would have enjoyed greater credibility if he had not first based his testimony on the much- older hockey injury to the face, rather than the newer injuries to the back from the automobile accident. In her cross-examination of Respondent, Petitioner's counsel tried to suggest that Respondent violated the standard of care by resuming the roxicodone prescription, after a five- month hiatus in visits between August 2008 and January 2009. However, Respondent first confirmed that J. K. was positive for oxycodone and, thus, not opioid-naïve. Respondent also explained that J. K. had seen a doctor in New Jersey while he was there visiting his mother. Essentially, for J. K., the standard-of-care opinion of Petitioner's expert witness is based entirely on inadequate medical records. The expert noted correctly that Respondent's medical records, which span two years, lack assessments, diagnoses, and treatment plans. At times, the medical records fail to support changes in medications. But Petitioner has failed to prove that Respondent's treatment of J. K. itself violates the standard of care because there is some correspondence between pain reports and prescription quantities. Petitioner proved a medical-records violation, but not a standard-of-care violation. K. G. From June 19, 2007, through July 27, 2009, Respondent prescribed to K. G. a monthly regime of 30-mg roxicodone pills. (All roxicodone prescriptions to K. G. are for 30-mg doses, unless otherwise indicated.) For the first four months, Respondent prescribed 300 roxicodone pills monthly. For the next four months, Respondent prescribed 280 pills monthly. For the next year, Respondent did not see K. G. When K. G. returned on December 19, 2008, Respondent prescribed 280 roxicodone pills, which he maintained for the next two months' prescriptions. On April 6, 2009, Respondent maintained the prescription at 160 30-mg roxicodone pills plus 240 15-mg roxicodone pills, which is the equivalent of 280 30-mg pills. On April 30, 2009, Respondent provided two prescriptions of 160 and 120 roxicodone pills, and, on May 26, June 24, and July 27, 2009, Respondent prescribed 280 roxicodone pills each month. K. G. presented to Respondent with complaints of lower back pain, probably resulting from two automobile accidents. An MRI of the lumbar spine showed a herniated disc at L5/S1, causing impingement of the right and left S1 nerve root, and a herniated disc at L4/L5. Dr. Deluca, who was no longer practicing, had been prescribing K. G. 120 80-mg Oxycontin® pills and 420 30-mg Oxycontin® pills, presumably monthly. K. G. had been switched to Suboxone®, which is used to withdraw a patient from opioids, but K. G. admitted to buying and using Oxycontin® on the street. The initial note contains a treatment plan. Claiming a pain level of "9," K. G. asked to resume Oxycontin®, but Respondent declined, based in part of K. G.'s history of high intake of opiates. Respondent instead suggested interventional pain management. A urinalysis administered on the initial visit was negative as to "everything." Respondent then prescribed ten roxicodone pills daily, perhaps revealing a belief that K. G. was not, in fact, opioid-naïve at the time. On K. G.'s next visit, on July 17, 2007, he tested positive for THC. In a medical note dated October 22, 2007, Respondent noted that K. G. had not seen the orthopedist, to whom he had referred him. Respondent found K. G. difficult to manage because he traveled a lot, working as a market maker for stocks. K. G. took Suboxone®, but only to avoid withdrawal symptoms from interruptions in his roxicodone regime while he was in other countries, where he presumably could not take his roxicodone. On January 4, 2008, Respondent placed K. G. on probation due to unspecified aberrations in behavior. K. G. promptly discontinued seeing Respondent for over ten months between January 4 and November 21, 2008. On his return, K. G. again tested positive for THC. Respondent testified that he counseled him not to continue to use marijuana, but his records do not document this fact. Respondent continued treating K. G. for another eight months without administering another urinalysis. Again, the medical records reveal no assessment, diagnosis, or treatment plan. Petitioner's expert witness pursued some false trails in trying to establish a standard-of-care violation. He complained about a split prescription on April 30, 2009, but there were only three such prescriptions over two years, and this record fails to reveal a sinister purpose in splitting prescriptions. About the worst thing that Petitioner's expert has to say about the practice is that he is "not sure of the purpose for that." (Tr., p. 70.) Petitioner's expert witness raised the issue of short-acting versus long-acting opioids, but this has already been addressed. Petitioner's expert objected to Respondent's prescription of Xanax® and Soma®, but, as already noted, Petitioner did not plead these matters. Petitioner's expert witness mentioned the polysubstance use of benzodiazepines and oxycodone--both prescribed--with marijuana. Petitioner's expert opined that patients who persist in using marijuana "need to be tapered off their [opioids] and referred for [substance abuse] counseling." (Tr., pp. 72 and 145.) Respondent's expert opined that practitioners are divided in what to do with patients whose aberrant behavior involves exclusively marijuana use. The standard of care as applied to marijuana use is discussed in the Conclusions of Law. Petitioner's expert finds firmer footing when he ties in the other aberrant behavior of K. G., including obtaining Oxycontin® on the street and K. G.'s on-again, off-again misuse of Suboxone® as a opiate-substitute, not as an agent to assist in opiate detoxification. When K. G. ignored Respondent's referral to an orthopedist, K. G. blatantly ignored Respondent's lone attempt to initiate a reexamination of the patient's underlying condition. There were one or more unspecified aberrant behaviors, and, when Respondent finally placed the patient on probation, K. G. quit seeing Respondent for ten months: on his return, he promptly tested positive for marijuana again. These facts are the grounds of the standard-of-care violation. As was the case with R. H. and K. L., so it is with K. G. By continuing to prescribe opioids and not treating the underlying condition, or tapering him off and then dismissing K. G. as a patient, if he refused to stop his aberrant behavior, Respondent essentially deprived K. G. of the treatment that he required. Petitioner proved a medical-records violation and standard-of-care violation. D. D. From June 30, 2008, through June 3, 2009, Respondent prescribed to D. D. a monthly regime of 290 30-mg roxicodone pills. And, in this case, a one-year span produced only 12 prescriptions. At his initial visit on June 30 or July 1, 2008, D. D., a diabetic in his 50s, presented with pain in both knees. His left knee had been replaced two years earlier and was doing well, but he was awaiting replacement of his right knee. D. D. had an abscess at L5/S1. He was on SSI disability. Although taking 30-mg and 15-mg roxicodone, D. D. wanted to get off the 30-mg pills because he had no insurance. Obese at 192 pounds, D. D. reported his pain to be an "8." The treatment plan involved converting D. D.'s 15-mg roxicodone pills for 30-mg roxicodone pills, despite his interest in dropping the 30-mg pills, but Respondent maintained the same dosage as had been prescribed by the preceding physician. Otherwise, the treatment plan consisted of discussing the rules of the Pain Management Center. Petitioner's expert witness complimented Respondent on his initial medical record: he called it a "well presented medical record, a good history there. I think this is an appropriate medical record." (Tr., p. 85.) And it is. Petitioner's expert also testified that the patient required opiate management. Laboring under a misunderstanding as to the amount of roxicodone that Respondent had prescribed on the first visit, Petitioner's expert was alarmed by what he thought had been a doubling on the second visit; in fact, the quantity had remained unchanged. In this case, given the short time of treatment and the extensive medical difficulties of the patient, whom Respondent described aptly as "one of the saddest patients I have" (Tr., p. 230), Petitioner's expert lacked support in the record for his opinion that Respondent was required to address eliminating pain medications from D. D.'s life. D. D. was a low-functioning person when he presented to Respondent, and the standard of care did not require, within one year, that Respondent either get D. D. off opioids or substantially improve his function. However, toward the end of the treatment period, D. D. enjoyed greater functionality, as he was able to help raise his grandson. Petitioner failed to prove a medical-records violation or a standard-of-care violation. J. M. From October 1, 2007, through July 3, 2009, Respondent prescribed J. M. a monthly regime of 30-mg roxicodone pills and Oxyfast bottles. (All roxicodone prescriptions to J. M. are for 30-mg doses, unless otherwise indicated.) On October 1, 2007, Respondent prescribed 240 roxicodone pills and one bottle of Oxyfast.® On October 23, Respondent maintained the roxicodone, but doubled the Oxyfast® to two bottles. Respondent maintained this prescription level the next month. On December 21, Respondent essentially maintained the same prescription level by prescribing 105 30-mg roxicodone pills and 273 15-mg roxicodone pills, as well as two bottles of Oxyfast.® On January 18, 2008, Respondent again maintained the same prescription level by prescribing 70 30-gm roxicodone pills and 340 15-mg roxicodone pills, plus two bottles of Oxyfast.® But four days later, Respondent prescribed another 70 roxicodone pills. On February 18, Respondent prescribed 240 roxicodone pills in two prescriptions--one for 70 pills and one for 170 pills--but no Oxyfast.® On March 25, Respondent prescribed 240 roxicodone pills--in separate prescriptions of 110 and 130 pills--and two bottles of Oxyfast®. Respondent repeated this prescription, but with a single roxicodone prescription each month, for the next nine months. The only exceptions were split prescriptions of 140 pills each on June 17 and the discontinuation of visits between June 17 and September 8. On February 24, 2009, Respondent reduced the prescription to 60 pills of 15-mg roxicodone. On March 23, he raised it to 300 pills of roxicodone--split into prescriptions of 120 pills and 180 pills--and two bottles of Oxyfast.® On April 17, Respondent prescribed two bottles of Oxyfast®, and, on April 23, Respondent prescribed 70 roxicodone pills. On May 15 and June 10, 2009, Respondent prescribed 300 roxicodone pills--divided into two prescriptions of equal amounts--and two bottles of Oxyfast®. On July 3, 2009, Respondent prescribed 300 roxicodone pills--divided into prescriptions of 80 and 220 pills--and two bottles of Oxyfast®. In the initial visit in 2002, J. M. presented as a 32-year-old male with lower back pain. He reported that he had injured his back a few months earlier picking up an object. Unable to lift, J. M. had had to quit working as a gardener. He had been taking four or five Percocet 10/325's daily. The treatment plan, which was prepared by Respondent, was to help J. M. quit smoking tobacco and convert him from Percocet, with the potential acetaminophen toxicity, to roxicodone. J. M. told Respondent that his girlfriend had let him try some of her Xanax®, which had helped him with spasms and sleeping, so Respondent prescribed that too. They also discussed that J. M. should exercise his COBRA rights on his insurance because he was going to get some evaluations, as well as epidural injections. An MRI of the lumbar spine performed on February 6, 2008, revealed multilevel central disc herniations at L2/L3, L3/L4, L4/L5, and L5/S1 with annular tears in the herniations at L3/L4, L4/L5, and L5/S1. The MRI disclosed mild spinal stenosis at L4/L5. None of the ten patients involved in this case displayed the same extent of objective bases for the pain of which he or she complained. In August 2007, while being seen by Dr. Morency at the Pain Management Center, J. M. expressed a desire to be seen by a different physician, but the medical record fails to reveal why. On October 1, 2007, when first treating J. M., Respondent continued the level of opioids that Dr. Morency had been prescribing. Respondent prescribed Oxyfast® with roxicodone because the former, as a liquid, has a faster onset than the pill, which can take 45 minutes to take effect. Respondent testified that he doubled the Oxyfast® on October 23 because the pain was worse. But, according to the medical records, J. M. reported pain of "5" on October 1, 2007, and, three weeks later, reported pain of only "3." On July 3, 2009, a urinalysis revealed THC. Respondent discussed with J. M. his aberrant behavior and placed him on probation, warning him not to test positive for marijuana again. However, J. M. had tested positive for marijuana on April 17, 2006, August 7, 2007, and October 23, 2007--each time he had been tested. Respondent did not test J. M. again for nearly two years. Petitioner's expert faulted Respondent for his handling, or lack of handling, of J. M.'s apparently ongoing marijuana use during treatment. This is addressed in the Conclusions of Law. Petitioner's expert witness faulted Respondent for using short-acting opioids rather than long-acting opioids, but this has been dealt with already. Except for the doubling of the Oxyfast® early in the period of treatment, the medical records fail to establish a correspondence between pain reports and prescription levels of roxicodone on three occasions: the two months during which Respondent supplemented the roxicodone prescription with 70 pills and the 25% increase in roxicodone in early 2009. The medical records lack assessments, diagnoses, and treatment plans. In particular, the medical records are deficient because they do not justify the three increases in prescribed opioids. But there is insufficient evidence of a standard-of- care violation as to J. M. There is insufficient evidence of aberrant behavior that would require Respondent to taper off J. M. from pain medications--despite well-documented sources of pain--while he obtained counseling to help him stop using marijuana. And the three instances in which increased prescriptions were not justified in the medical records prove a medical-records violation, not a standard-of-care violation, as discussed in the Conclusions of Law. No other evidence in the record establishes a lack of justification for the prescribed opioids. Petitioner proved a medical-records violation, but not a standard-of-care violation. M. L. From April 26, 2007, through March 3, 2009, Respondent prescribed to M. L. a monthly regime of 30-mg roxicodone pills, except for a single prescription of oxycodone and two prescriptions of Percocet® 10/325. (All roxicodone prescriptions to M. L. are for 30-mg doses.) On April 26, 2007, Respondent prescribed 440 mg of roxicodone pills in two prescriptions--one for 200 pills and one for 240 pills. Respondent repeated this prescription monthly for seven months--eight times--when, on December 6, 2007, he raised it to 540 mg in two prescriptions--one for 290 pills and one for 250 pills. Starting January 8, 2008, Respondent returned to his initial pattern of prescribing 440 pills of roxicodone in two prescriptions. This continued through 2008--again, counting January 8, this amounted to 13 prescriptions, not 12, over the year. Respondent continued this prescription pattern on January 6 and February 2--the latter incorporating 40 15-mg roxicodone pills to achieve the same total prescription in dosage. On March 3, 2009, Respondent prescribed 150 roxicodone pills, 210 5-mg oxycodone pills, and 210 Percocet® 10/325 pills. In 1999, David Buchalter, M.D., referred M. L. to the Pain Management Center with a report stating that an MRI suggested that the patient had a small herniated disc at C3/C4, a mild disc bulge at C4/C5, and degenerative disc space narrowing at C5/C6. By the time that Respondent saw M. L., he had been complaining of neck and lower back pain for many years. M. L. could not afford Oxycontin®, but a urinalysis confirmed that he was taking his prescribed short-acting opioids. M. L. had been seen by the Pain Management Center for several years, and he had never exhibited aberrant behavior. Nothing stands out in the record concerning the care received by M. L., although, again, two years of medical records contain no assessment, diagnosis, or treatment plan. Petitioner proved a medical-records violation, but not a standard-of-care violation. M. P. From February 12, 2007, through July 7, 2009, Respondent prescribed to M. P. a monthly regime of Oxycontin and methadone initially and, later, mostly roxicodone. (All roxicodone prescriptions for M. P. are for 30 mg, unless otherwise indicated.) M. P. had been seen by the Pain Management Center since at least 2002. He was operating a forklift in 1999 when boxes fell on him, injuring his neck. An MRI revealed a ruptured disk at C3/C4, a disc bulge at C4/C5, and degenerative disc disease at C5/C6. At the time of the office visit, M. P. was still employed driving a forklift, but was taking 120 mg of Oxycontin® daily. Despite a medical record dated January 5, 2006, stating that M. P. could not afford Oxycontin®, he was still on this relatively expensive, long-acting opioid at the start of the period in question. During his years of treatment at the Pain Management Center, M. P. had never displayed any aberrant behavior, as periodic urinalyses revealed that M. P. was taking his prescribed opioids and nothing else. The medical records during the period in question contain no patient assessments or treatment plans, nor do they explain the switching of medications. Of particular interest, as to the standard of care, is the relatively long period that Respondent prescribed two long-acting opioids, methadone and Oxycontin®. As Petitioner's expert testified, such overlapping is appropriate during a dosage-transition phase, as the practitioner transitions the patient from one such opioid to another. But here, Respondent prescribed methadone and Oxycontin for five months. At the end of this period, Respondent discontinued the Oxycontin®, but there is no constant tapering off of Oxycontin® during this period. From February to July 2007, the monthly prescriptions for Oxycontin® are for 14,400 mg, 14,400 mg, 14,400 mg, 14,400 mg, 0 mg, and 4800 mg. As noted above, methadone is difficult to use for analgesic purposes. Doubtlessly, this difficulty is increased by adding another long-acting opioid, even if its half life is much shorter than the half-life of methadone. But this is really all that Petitioner presents for a standard-of-care violation. Although it is a close question, Petitioner's evidence fails to convince that five months' dual prescribing of two long-acting opioids was inappropriate, excessive, or unjustified. Petitioner's expert questioned the amount of roxicodone prescribed, in conjunction with methadone, for back pain. This criticism was less well-founded, as Respondent eventually discontinued the methadone also. Additionally, M. P. tended to report high pain levels during the period in question. Again, during the two and one-half years of relevant treatment, the medical records fail to include an assessment, diagnosis, or treatment plan, including any guide to the transitioning of the patient off of two long-acting opioids. Petitioner proved a medical-records violation, but not a standard-of-care violation.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order finding Respondent guilty of nine counts of medical-records violations and four counts of standard-of-care violations and imposing $107,500 in administrative fines, four years' suspension from the practice of medicine, 200 hours' community service, six years' probation after completion of the suspension, restrictions upon Respondent's license after it is reinstated, coursework, and costs. DONE AND ENTERED this 23rd day of June, 2011, in Tallahassee, Leon County, Florida. S ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 23rd day of June, 2011. COPIES FURNISHED: Shirley L. Bates, Esquire Grace Kim, Esquire Department of Health 4052 Bald Cypress Way, Bin C65 Tallahassee, Florida 32399-1701 Sean Michael Ellsworth, Esquire Ellsworth Law Firm, P.A. 1501 Collins Avenue, Suite 208 Miami Beach, Florida 33139 Renee Alsobrook, Acting General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Larry McPherson, Jr., Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399
