Findings Of Fact At all times material hereto, Respondent Maria C. Perez has been licensed as a pharmacist under the laws of the State of Florida, having been issued license number 0018025. At all times material hereto, Respondent Perez has been the managing pharmacist at Respondent San Lazaro Pharmacy. At all times material hereto, Respondent San Lazaro Pharmacy has been the holder of a permit to operate a community pharmacy under the laws of the State of Florida, having been issued permit number 0002864. At all times material hereto, Olegario Cepro (or Cepero) was employed at Respondent pharmacy. At no time material hereto was Cepro licensed as a pharmacist or registered as a pharmacy intern in the State of Florida. On March 1, 1983, Georgina Jorge, an investigator with the Department of Professional Regulation, entered the Respondent pharmacy. Jorge asked Cepro for 30 Berocca tablets, 10 Librax capsules, and 5 Darvon Compound capsules. Cepro went into the dispensary department and thereafter delivered to Jorge 45 pills. At no time during this transaction did Jorge present Cepro with a prescription. On March 1, 1983, the pills received were taken to the Metropolitan Dade County Crime Laboratory. A subsequent chemical analysis of the pills revealed the presence of the controlled substance known as chlordiazepoxide, the active ingredient in Librax, a medicinal drug requiring a prescription for dispensing. Another sample which was analyzed revealed the presence of the controlled substance known as dextro propoxyphene, the active ingredient in Darvon Compound, a medicinal drug requiring a prescription to be dispensed. The suspected Berocca was not analyzed. On March 8, 1983, Jorge returned to the Respondent pharmacy. She asked Cepro for 10 penicillin tablets, 20 Valium tablets, and 10 Darvon Compound capsules. Cepro obtained from the pharmacy dispensary and gave to Jorge 10 tablets which appeared to be penicillin, 20 tablets which appeared to be Valium, and 20 capsules which appeared to be Darvon Compound. At that time, Respondent Perez was in the pharmacy dispensary. At no time during this transaction did Jorge present Cepro with a prescription. On March 8, 1983, the above substances were taken to the Metropolitan Dade County Crime Laboratory. A subsequent chemical analysis of the pills revealed in one sample the presence of penicillin, a medicinal drug requiring a prescription for dispensing. Analysis of another substance revealed the presence of the controlled substance diazepam, the active ingredient in Valium, a medicinal drug requiring a prescription for dispensing. On March 25, 1983, Jorge went to the Respondent pharmacy and asked Cepro for prices on bottles of Valium, Mebaral, Lomotil, Ritalin, Trofanil, and Lasix. Prices were quoted to Jorge by Cepro. Thereafter, Cepro delivered to Jorge 20 apparent Valium tablets, 36 apparent Ritalin tablets, 250 apparent Mebaral tablets, and 20 apparent Darvon Compound capsules. On this occasion, Jorge observed Respondent Perez, the licensed managing pharmacist, in the dispensary. At no time during this transaction did Jorge present Cepro with a prescription. On March 25, 1983, the substances which Jorge had received at the Respondent pharmacy were taken to the Metropolitan Dade County Crime Laboratory. A subsequent chemical analysis of the substances revealed the presence of the controlled substance known as methylphenidate, the active ingredient in Ritalin, which is a medicinal drug requiring a prescription to be dispensed. Methylphenidate is a Schedule II controlled substance pursuant to Chapter 893, Florida Statutes. Laboratory analysis of additional substances received from the March 25, 1983, transaction revealed the presence of the controlled substance known as mephobarbital, the active ingredient in Mebaral, a medicinal drug requiring a prescription for dispensing. In addition, one of the 20 capsules received was analyzed and revealed the presence of the controlled substance known as propoxyphene, the active ingredient in Darvon Compound, which is a medicinal drug requiring a prescription for dispensing. On March 28, 1903, Jorge went to the Respondent pharmacy once again. She asked Cepro for 20 Valium tablets and 20 Lomotil tablets. Jorge saw Respondent Perez in the prescription department. Cepro went into the prescription or dispensary department and returned with suspected controlled substances. At no time during this transaction did Jorge present Cepro or Respondent Perez with a prescription. On March 28, 1983, the suspected controlled substances were taken to the Metropolitan Dade County Crime Laboratory for analysis. A subsequent chemical analysis of the tablets revealed the presence of the controlled substance known as diazepam, the active ingredient in Valium, a medicinal drug requiring a prescription for dispensing. On March 28, 1983, an audit of the controlled substances was conducted at the Respondent pharmacy by Edward Bludworth, an investigator with the Department of Professional Regulation. That audit revealed that Respondents could not provide prescriptions or other documentation to show the dispensing of 41 Darvon Compound-65, 1,005 Valium 5 mg., 801 Valium 10 mg., 280 Tranxene 3.75 mg., 33,451 Talwin 50 mg., and 20 Talwin injectable vials. Darvon, Tranxene, Valium, and Talwin are all compounds containing controlled substances as defined in Chapter 893, Florida Statutes. Petitioner presented no evidence concerning the allegations of Count III [sic II; paragraphs 13, 14, 15, and 16] of the Administrative Complaint filed against Respondent Perez in DOAH Case No. 83-2918.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered dismissing Count III of the Administrative Complaint filed against Respondent Maria C. Perez, finding her guilty of Counts I and II of the Administrative Complaint filed against her, and revoking her license to practice pharmacy in the State of Florida. It is further RECOMMENDED that a Final Order be entered finding Respondent San Lazaro Pharmacy guilty of each and every count in the Administrative Complaint filed against it and revoking its permit to operate a community pharmacy in the State of Florida. DONE and RECOMMENDED this 27th day of March, 1984, 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 March, 1984. COPIES FURNISHED: Bruce D. Lamb, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 A. M. Schwitalla, Esquire 135 Almeria Avenue Coral Gables, Florida 33134 Frederick Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Wanda Willis, Executive Director Board of Pharmacy 130 North Monroe Street Tallahassee, Florida 32301
The Issue At issue in this proceeding is whether respondent committed the offenses charged in the administrative complaint and, if so, what disciplinary action should be taken.
Findings Of Fact Petitioner, Department of Professional Regulation (Department), is the state agency charged with regulating the practice of pharmacy and the operation of pharmacies pursuant to Section 20.30, Florida Statutes, and Chapters 455 and 465, Florida Statutes. At all times material hereto, respondent, South Miami Heights Pharmacy, was a registered community pharmacy in the State of Florida, having been issued license number PH 0000880. Respondent's business is located at 11503 Quail Roost Drive, Miami, Florida 33157-6547. On or about July 9, 1991, an inspection was conducted of respondent's premises by the Department's investigator, Agustin Garcia, and a Department of Health and Rehabilitative Services (HRS) drug agent supervisor, Cesar Arias. Such inspection revealed approximately fifty nine (59) containers of expired medicinal drugs within the pharmacy dispensing area; however, only approximately seventeen (17) containers clearly bore an expiration date that was over four months old at the time of the inspection. [Petitioner's exhibit B]. Additionally, five (5) containers of Salbutan Inhalor, a foreign-made version of a domestic product that has not been approved for use in the United States, was found immediately adjacent to, but not within, the pharmacy dispensing area. In addition to the expired medicinal drugs located in the pharmacy dispensing area, a number of expired pharmaceuticals were located outside the pharmacy dispensing area. Such pharmaceuticals, the quantity of which does not appear of record, were, however, properly secured or "quarantined" for ultimate return to the manufacturer in accordance with the provisions of Rule 10D- 45.0535(6), Florida Administrative Code. Mr. Pablo Hernandez, the owner of petitioner, South Miami Heights Pharmacy, was not present when the aforesaid inspection occurred, nor had he been on the premises for some time prior thereto. Rather, Mr. Hernandez had been absent since April 12, 1991, when he underwent an operation for prostate problems, and did not return until July 30, 1991. In the interim, Mr. Hernandez' wife, Eva, supervised petitioner's business operations, but, since she was not a licensed pharmacist, never entered or supervised the pharmacy operation.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be rendered finding respondent guilty of violating Section 499.055(5), Florida Statutes, and Rules 10D-45.0535(5) and 10D-45.0365(15), Florida Administrative Code, which places respondent's license on probation for a term of two (2) years, subject to such terms and conditions as the Board of Pharmacy deems appropriate, and which imposes an administrative fine of $1,000.00. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 19th day of February 1993. WILLIAM J. KENDRICK 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 19th day of February 1993. APPENDIX TO RECOMMENDED ORDER Petitioner's proposed findings of fact are addressed as follows: 1. Addressed in paragraph 2. 2-4. Addressed in paragraph 3, otherwise rejected as contrary to the credible proof. Respondent submitted a proposed recommended order which did not set forth any proposed findings of fact. To the extent the section denoted "Background" could be so constructed, it is rejected as recitation of testimony and argument, and not findings of fact. COPIES FURNISHED: Wayne H. Mitchell, Esquire Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0752 George M. Santamarina, Esquire Toledo Center, Suite 204 7175 Southwest 8th Street Miami, Florida 33144 John Taylor, Executive Director Board of Pharmacy Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792 Jack McRay, General Counsel Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792
Findings Of Fact Alexander G. Toth graduated from medical school in 1943 and migrated to Miami in 1948. He took his three-year residency in general surgery at the V. A. Hospital in Miami starting in 1951 and thereafter practiced general surgery until 1976 when he had a serious accident. This accident plus additional health problems caused him to give up surgery and he has practiced family medicine since 1976. His office hours have been limited from 9 until 12 each week day since 1976. Approximately 10 patients per day were seen by Respondent during the period involved in these charges. At all times here relevant Respondent was licensed by Petitioner as a physician. Richard Hatcher was a patient of Respondent in 1975 at which time he complained of headaches and low back pain. Respondent prescribed Percodan, Doriden, Dilaudid and Placidyl during a one-year period Hatcher was a regular patient. At this time Hatcher had a suit pending to recover damages for injuries received in an automobile collision. Hatcher did not see Respondent with any regularity again until 1978. Respondent's patient records of Hatcher (Exhibit 5) show he treated Hatcher on 11-20-78 on complaint of can't sleep, low back pain and spasm of lower back, by prescribing 100 Valium and 100 Percodan. Exhibit 6, which is a copy of prescriptions written by Respondent for Hatcher, shows the following prescriptions were written for Hatcher on dates indicated: 6/2/78 - 30 Valium 10 mg; 8/8/78 - 50 Seconal and 30 Fastin 30 mg; 10/11/78 60 Tuinal 3 grs, 60 Fastin 30 mg, 50 Valium 10 mg and 100 Percodan; and 11/20/78 - Valium 10 mg, 30 Fastin 30 mg and 100 Percodan. Exhibit 5 shows in 1975 Hatcher was 6 feet and 180 pounds. The entry dated 12/18/78 opposite Fastin is (Wt 205). During the period 12/18/78 to 2/27/79 Respondent prescribed for Hatcher on numerous prescriptions the following: 300 Percodan, 250 Valium, 230 Tuinal 3 gr, 60 Fastin, 60 Demerol 100 mg, one 30 cc vial Demerol 100 mg per cc, and 30 syringes (Exhibit 6) . Exhibit 5 contains an entry dated 3/2/79 "(Wants Demerol) Refused - refer to JMH", and a final entry (3-19) Deceased." Hatcher voiced the same or similar complaints of pain on each visit to Respondent. Richard Hatcher was found dead in his apartment on or about 21 March 1979 some 24 to 36 hours after he died. Cause of death was acute intravenous narcotism. The syringe with which the fatal narcotic was injected was still in his arm when his body was found. Due to the rapid clearing of many drugs from the blood the autopsy failed to reveal which of the opiate drugs caused Hatcher's death. About one week later Mrs. Hatcher, the mother of Richard, received from her ex-husband and father of Richard a page from a notebook found in Richard's apartment after his death signed by Richard which indicates some concern by Hatcher that he might overdose on drugs given him by Dr. Toth, the Respondent (Exhibit 12). Richard Hatcher became seriously involved with drugs in 1967 when he was 21 years old. By 1975 his mother noted a personality change where he would quickly go from normal to extremely agitated. In the fall of 1978 Hatcher committed himself to Village South, a drug rehabilitation program in Dade County, for some 4 or 5 months. After release from Village South Hatcher continued to take drugs. To his mother's knowledge he overdosed several times before his death. Three times she found him unconscious on the floor of her apartment and on numerous other occasions he was "spaced out". Respondent testified that Hatcher showed no indication he had abused or misused the medications Respondent prescribed. If so, it is evident that Respondent did not closely observe Hatcher or do more than hear his litany of pain. On the other hand, Exhibit 5 shows that some 2-1/2 weeks before Hatcher's death Respondent refused to prescribe the Demerol wanted by Hatcher. Unless Respondent recognized the seriousness of Hatcher's addiction it is not conceivable that he would suddenly refuse drugs so freely prescribed in the past. Michael Kavney was a patient of Respondent from June 1979 until his death from an overdose of Placidyl on 14 or 15 January 1980. On June 11 1979 Kavney complained of pain in his shoulder and Respondent prescribed 50 Tylenol. Kavney was 6 feet tall, weighed 189 pounds, and told Respondent he wanted to lose weight. Respondent on June 11, 1979 also prescribed 50 Fastin. On 8-16-79 Respondent, at Kavney's request, called in a prescription for 50 Valium. On 9/7/79 he called in a prescription for 50 Tylenol. Both of these prescriptions resulted from a phone call to Respondent. On October 29, 1979 Kavney visited Respondent, told him the shoulder pain persists and he would like some more weight reducers. By this time Kavney's weight was down to 185 pounds from 189 four months earlier. Respondent prescribed 50 Tylenol, 50 Valium (Exhibit 4) and 30 Fastin (Exhibit 3). By script dated 11/21/79 Respondent prescribed 50 Fastin for Kavney and by script dated 11/26/79 he prescribed 50 Tylenol (Exhibit 4). No record of these is contained in Exhibit 3. By entry on Exhibit 3 dated December 17, 1979 Respondent recorded "pain left shoulder, using heat at home, can't take codeine, Percodan 50". The Tylenol, which had been prescribed on four previous occasions, contains 1 grain of codeine per tablet. On January 14, 1980 Kavney visited Respondent, told him of disturbed sleep patterns, that he had taken Placidyl on prior occasions with good results and Respondent prescribed 60 Placidyl (750). Kavney was found dead in his automobile with an empty bottle with Placidyl label on the floor. An autopsy done on January 15, 1980 shows Kavney died from an overdose of Placidyl. Terry McGarey grew up in Miami and played in bands with Kavney as early as high school days. He had also known Hatcher since 1963. McGarey first visited Respondent in 1970 with an arm injury. He next saw Respondent near the end of 1976 and he complained of headache and leg pains from an earlier motorcycle accident. McGarey received a prescription for Percodan. McGarey, who appeared as a witness, testified that he had visited Respondent every three or four weeks in 1976 complaining of headache and during these visits he also received Placidyl, Demerol, Parest and Valium. These visits continued in 1977 with the same frequency and results. Respondent's patient records for Terrance McGarey (Exhibit 1) commence 3/28/78. The first entry is not dated but states "cc severe headaches - nausea - at JMH March `78. Neuological dept. - treated for organic brain syndrome - at JMH 1976 migraine - no allergies - only relief Demerol. Rx demerol 100 mg #5 fiorinal tabs." Thereafter Exhibit 1 shows entries 7-31-78, 8-7-78, 8-28, 9-1, 9-6, 9-11, 9-27, 10-9, 10-20, 10-29, 10-31, 11-16, 11-22, 12-18, 12-22, 12-29, 1-3, 1-8, 3-21 and 4-19-79. Most of these entries resulted from office visits but some entries recorded prescriptions as a result of phone calls. During this period prescriptions were issued to McGarey for Percodan, Emperin, Doriden Parest, Tuinal, Demerol, Placidyl, Dalmane, Darvon, Seconal and Valium (Exhibit 2) On May 7, 1979 McGarey called the Cardella Pharmacy saying he was Dr. Toth, gave the correct DEA number and authorized the delivery of 18 Placidyl 50 mg to patient Jerry McGaret. The pharmacist called the doctor's office, which was closed, and then issued the drugs to McGarey. A subsequent try was unsuccessful when the pharmacist was told by Respondent's office that this man was no longer a patient of Respondent. Respondent testified that he treated McGarey for migraine headaches, insomnia, nervousness, and low back pain. He found no evidence of abnormal conditions in his examination of McGarey. Through mid-October Respondent had no indication McGarey was in a methadone program or addicted and the drugs were continued with each visit or phone call. On December 29 Respondent learned from McGarey that he had been admitted to JMH for seizures and the resident recommended Seconal. On this basis Respondent prescribed Seconal but did not learn the cause of the seizures. On January 8, 1979 McGarey's mother called Respondent to advise that her son was a drug abuser and had been on a methadone program for 18 months. Following this entry is the notation "No more Rx's - back to JMH". Respondent's next entry on Exhibit 1 is "Called records at JMH patient admitted 2-9-79 - overdosed - discharged 2-14 Signed out - mother took him home." Although Respondent testified it never entered his mind that McGarey might be a drug abuser he also testified that the symptoms of narcotic addiction are agitation, nervousness, slurred speech and poor equilibrium. On the witness stand McGarey exhibited traits of nervousness and agitation. He appeared hyperactive rather than calm and sedate. His movements were jerky rather than fluid and he did not give the impression of a normally relaxed person under tension because he was testifying. On 11 January 1980 Kirk Kratz, a 29-year-old male, visited Respondent's office as a patient. He had a cast on his right upper arm and stated it was fractured some two weeks earlier. Also he had received a gunshot wound in the abdomen before Christmas and a laparotomy had been performed. He complained of pain in the right arm. He was given a prescription for 100 Percodan for pain and 60 Tuinal 3 gr for sleep. Kratz returned 12 February with same complaints and was given prescriptions for 100 Percodan, 60 Tuinal and 30 Valium. On 2/29 Kraft appeared without the cast, told Respondent the police had broken the cast, held him in jail for 3 days and confiscated his medication. He was given prescriptions for 100 Percodan and 60 Tuinal. On 4/8/80 Kratz still complained of "pain in the shoulder and arm and can't sleep." Prescriptions for 100 Percodan, 60 Tuinal and 100 Valium were given him. Finally on 6/13, with complaint of pain in hand and shoulder, Kratz was given prescriptions for 100 Percodan and 30 Doriden (Exhibit 9). Hatcher and McGarey were drug addicts before and during the time they were being treated by Respondent. At one time or another both of them had been enrolled in the methadone program at Jackson Memorial Hospital and/or other withdrawal programs for addicts. In addition to getting drugs from Respondent, they were also obtaining drug prescriptions from other doctors. Also from the quantity of drugs prescribed for Kavney and Kratz it is evident that both of these individuals were also addicts. During the period between 1 January 1980 and 14 June 1980 Respondent, with an active practice of some 700 patients prescribed approximately 28,000 Percodan and 2,000 Percocet tablets to various patients. Exhibit 16 shows a breakdown of the 130 patients treated by Respondent during this period. While Exhibit 16 shows Kirk Kratz received 100 Percodan only on 2/29/80, Exhibit 8 indicates he received 500 Percodan between 1 January and 14 June 1980. Assuming all other entries on Exhibit 16 to be accurate, a spot check shows the following patients were given Percodan or Percocet during the period 1 January - 14 June in the following quantities: Steven Arnold - 300; Cathy Blauk - 450; Bill Davis - 500; Kirk Decker - 300; George Fernandez - 300; Sidney Ford - 600; Ron Jangie - 300; Jerome Johnson - 300; Patty La Fortuna - 310; Vincent La Fortuna - 200; William Leonard - 350; Mary Leslie - 300; Gus Melquezo - 400; Michael Pravioski - 225; Debbie Saey - 250; Robert Sandifer - 400; James Setters - 300; Alvin Terrell - 300; Mike Thill - 300; Mark Wolfson - 200; Joe Worth - 300; and Harvey Zemaster - 200. Exhibit 16 also shows that most of these prescriptions were written for quantities of 100. It also lists almost 18,000 Percodan issued to 130 patients during this period, or an average of 140 per patient. Percodan, Tuinal, Parest, Demerol and Seconal are Class II drugs. One hundred Percodan taken in a one-month period will cause addiction in the taker. After 48 hours taking Percodan every 4 to 6 hours the patient will have withdrawal symptoms. Although Placidyl, Valium, Doriden, Empirin and Dalmane are not Class II drugs, they are dangerous and therefore controlled. Fifteen Placidyls taken at one time can be fatal. Many of the drugs prescribed by Respondent, when taken in combination, create a synergistic effect which makes the combination greater than the sum of its parts. Similarly a synergistic effect is created when some of these drugs are taken in conjunction with alcohol. Fastin is used for weight control. Neither Hatcher nor Kavney at 6 feet and 180 - 185 pounds should have been a candidate for weight loss. Further, prescriptions for Fastin and Seconal (for sleep) at the same time are incompatible as one is an upper, the other a downer. Tuinal in combination with Valium will increase depression. When Fastin is added, a pharmacological jungle can result. Respondent acknowledged that he relied more on the statements of his patients than upon an examination to determine when to prescribe medications. If the patient said he hurt, Respondent would prescribe a pain killer. A two- week-old fracture properly set and in a cast should cause little pain. If pain persists two weeks after casting something is wrong that will not likely heal itself. Therefore, painkillers to mask the symptoms are contraindicated. Similarly, a persistent pain in the shoulder is likely to be caused by inflammation and an anti-flammatory agent is indicated. Neither Tylenol nor Percodan are anti-inflammatory agents. Dr. John V. Handwerker, M.D. was accepted as an expert in family practice medicine. After reviewing Respondent's records of Hatcher, Kavney, Kratz and McGarey he expressed the strong opinion that the complaints of the patients did not justify the narcotics prescribed; that much larger quantities of each drug were prescribed at one time than was medically indicated or prudent; that drugs were prescribed in dangerous combinations due to the synergistic effect if taken together, plus some of these drugs such as Fastin and Valium are mutually exclusive; that issuing a prescription to take these drugs "as needed" was improper and dangerous; and that narcotics were frequently prescribed for alleged ailments for which more effective non-narcotic drugs were available. This witness was particularly critical of the prescription for liquid Demerol, as this should be prescribed only when the patient can't take the drug orally. After reviewing Exhibit 7 Dr. Handwerker expressed the opinion that prescribing 28,000 Percodan tablets during a 5-1/2 month period could only be justified with a large practice limited to trauma patients and that the records and prescription schedules show a practice harmful to the public. This opinion was based partially on Dr. Handwerker's practice in which, during the same period, he saw 2,081 patients and wrote 73 prescriptions for 1,996 Percodan tablets. Exhibit 7 contains 291 prescriptions issued by Respondent during this period, and recovered by Petitioner's investigator from pharmacies in the vicinity of Respondent's office. These coupled with Respondent's patient records show some 28,000 Percodan and 2000 Percocet tablets were prescribed. Valium is the most commonly prescribed drug in the United States and one of the most abused drugs. If a patient is emotionally stable 60 Valium is too many to prescribe for a patient at one time. If a patient is emotionally disturbed there is even greater reason for not prescribing 60 Valium. Dr. Roderick Palmer, M.D., testified as an expert in clinical pharmacology. He opined that prescribing 100 Percodan for a patient at one time was not appropriate because if the pain results from a traumatic injury, such injury will normally cease being painful in 4 or 5 days, and 100 Percodan is enough to commit suicide or become addicted. Dr. Palmer described Percodan and Placidyl as widely abused drugs. Sixty Placidyl in one prescription is too many because of suicide potential. Further, if one Placidyl is taken every day for 60 days the patient would probably become addicted. Taking more than one Placidyl per day could impair coordination enough to result in an industrial or automobile accident or other injury. With respect to Exhibit 7, Dr. Palmer cited instructions for Percodan or Percocet that the physician should not prescribe enough to result in addiction (not more than 30) nor prescribe enough for patient to commit suicide. It is necessary for patients to return to the physician before the patient can become addicted to the drugs prescribed. In this way the doctor will not lose control over the patient which could result in the patient becoming addicted. With respect to the 28,000 Percodan prescribed in a 5-1/2 months period Dr. Palmer viewed that quantity as more than he would prescribe in a lifetime. Dr. Murray Sims, M.D., is a Board certified surgeon who testified on behalf of Respondent. He found the prescriptions issued to Hatcher, Kavney, McGarey and Kratz to be proper for the complaints of the patients. Sims has known Respondent for many years, and has worked, studied, and taken examinations with Respondent. Dr. Sims prescribes Percodan in quantities of 100 and even 200. He does not believe 100 Percodan taken in a 30-day period is addictive. He has one 93-year old patient to whom he mails prescriptions for 100 Percodan per month (40 to 60 days) because, as she told him, "It makes my day start off right." (Tr. Vol. II, p. 102). When asked if Percodan and Tuinal taken together would have a synergistic effect Dr. Sims said no (Tr. Vol. II, p. 67) but on p. 119 he testified "I guess it would, you get a relief of both, yes. Don't hold me too much about pharmacy." Dr. Sims practice is 99 percent devoted to surgery patients and if he has a patient with a non-surgical related disorder he usually refers the patient to another doctor. This witness's testimony regarding the various drugs prescribed by Respondent and the appropriateness thereof was not deemed as credible as was the testimony of Drs. Hardwerker and Palmer. This was so because the latter had more expertise in this area of medicine and demonstrated greater credibility on the witness stand.
The Issue Whether or not on or about May 24, 1978, the Respondent was arrested by officers of the Jacksonville Sheriff's Office, in Jacksonville, Duval County, Florida, and found to be in illegal possession of the controlled substance, to- wit, Pentothal (Sodium Thiopental), injectable, and, therefore, in violation of Subsections 464.21(1)(b) and (d), Florida Statutes. Whether or not on or about May 24, 1978, the Respondent was found to be in possession of several prescription drugs without having obtained a prescription for those drugs, in violation of Subsection 464.21(1)(b), Florida Statutes.
Recommendation It is recommended that the license of the Respondent, Gloria Nesmith Moore Callender, R.N., No. 48527-2, be REVOKED. DONE and ENTERED this 28th day of November, 1978, in Tallahassee, Florida. CHARLES C. ADAMS, Hearing Officer Division of Administrative Hearings Room 101, Collins Building Tallahassee, Florida 32301 (904) 488-9675 COPIES FURNISHED: Julius Finegold, Esquire Geraldine B. Johnson, R.N. 1005 Blackstone Building Department of Professional and Jacksonville, Florida 32202 Occupational Regulation Board of Nursing Ms. Gloria N. M. Callender 6501 Arlington Expressway, 8030 Almar Place Bldg. "B" Jacksonville, Florida 32208 Jacksonville, Florida 32211
The Issue Whether disciplinary action should be taken against Respondent's license to practice medicine based on the administrative complaint in this case, which charges, in general, that he obtained his license through fraudulent misrepresentations and is unable to practice medicine safely because of illness or use of drugs he prescribed for himself illegally under the names of fictitious patients?
Findings Of Fact The Parties Petitioner, the Board of Medicine, created by Chapter 458, Florida Statutes, (the "Medical Practice Act,") is the regulatory authority charged with regulating the practice of medicine in the State of Florida. The Board is within the Agency for Health Care Administration, Section 20.42, Florida Statutes, which, in turn, is within the Department of Business and Professional Regulation. Id. In particular, as is pertinent to this case, the Board has the power to impose disciplinary penalties on a licensee when it finds guilt of any of the grounds set forth in subsection (1) of Section 458.331, Florida Statutes, the "grounds for disciplinary action" section of the Medical Practice Act. Respondent, John Mark Pennington, M.D., is currently a licensee of the Board of Medicine. He has been continuously licensed as a physician in Florida since March 11, 1994. Currently residing in Terra Ceia, Florida, Respondent has a specialty in anesthesiology. He does not, however, presently practice in his specialty. He practices, instead, as a physician in a walk-in medical clinic where he is closely monitored and his access to drugs and medication is completely restricted. The reason for not presently practicing as an anesthesiologist and being closely monitored at the walk-in clinic is the same: an addiction to narcotics. In recovery from the disease of chemical dependency at the time of hearing, and as long as he remains in recovery, Dr. Pennington is not presently impaired as the result of his addiction. Respondent's Checkered Past History of Drug Use Dr. Pennington's use and abuse of drugs spans many years. His illegal drug use began when he was a teenager in high school. In addition to drinking, he was using marijuana, cocaine and other drugs. He continued in college to use drugs, including amphetamines. In 1981, Dr. Pennington graduated from pharmacy school and began work as a pharmacist licensed by the State of Georgia in the City of Savannah. During his employment, he would take from the pharmacy, without the benefit of a medical prescription and without authorization from the pharmacy, certain drugs for his personal use. These included opiate derivatives, Hydrocordone, for example, which are classified as narcotics, as well as amphetamines and amphetamine-like medications such as Ritalin. Sometime in 1981, shortly after he began using narcotics, Dr. Pennington became addicted to them. Dr. Pennington managed to conceal his narcotic addiction from his closest associates, including his former wife, who was employed as a fellow pharmacist with him at the pharmacy in Savannah. In 1985, following an inventory at the pharmacy that indicated a discrepancy in narcotics, Dr. Pennington admitted his drug usage. He went directly into treatment at Willingway Hospital in Statesboro, Georgia where he remained for six weeks until his release. As the result of the discovery and Dr. Pennington's admission, disciplinary proceedings were brought against Dr. Pennington by the Georgia State Board of Pharmacy. The Georgia Administrative Hearing At the hearing during those proceedings, Dr. Pennington acknowledged his addiction. He testified that he knew that he would have to deal with addiction the rest of his life. But, he further testified, thanks to being in recovery as a result of the program at Willingway and a continuing program of treatment, that he was then drug-free and committed to remaining so. Moreover, he testified, that he felt there was no pressure too great to cause him to return to illicit use of drugs. In his view, no pressure was too great because he was committed to the ongoing drug treatment program in which he was then involved. He found the program to be an effective method for dealing with the addiction, a method he had not even known existed prior to his entry into the Willingway program. With regard to the effect the addiction and his behavior had on his life and others, Dr. Pennington testified: There is no way I can really express the guilt I feel and the remorse I feel for what I have done. I just want to do my best, and whatever the Board wants I will follow any direction they want me to go into. I embarrassed my profession by doing this. I almost lost my life, and my family, and my job and everything else. Regardless of what decision is made, I am going to go in the right direction to get my life back to the way it's supposed to be. Petitioner's Ex. No. 4, pgs. 46 - 47. At this same hearing on the Georgia disciplinary proceeding, Dr. Pennington called as witnesses on his behalf his then current employer, Mr. Rupert Heller, and his then wife, Kim Pennington. Mr. Heller testified that he had allowed Dr. Pennington to return to work at his pharmacy as a pharmacist. But the return was subject to certain conditions. The conditions included weekly random urinalyses, direct supervision by other pharmacists, no access to medications and lie-detector tests when requested. Mr. Heller also testified that Dr. Pennington was a competent, conscientious pharmacist who always performed well the duties of his employment. Kim Pennington testified that she had been unaware that Dr. Pennington had used drugs prior to the revelation of early 1985. She also testified about her involvement in Dr. Pennington's treatment program at Willingway, including spending five days at the facility to integrate her into his care and attendance at family counseling sessions. Persuaded by the testimony of Dr. Pennington, his employer and his wife, Kim, and recommendations by the Attorney for the Board, the hearing officer wrote the following in his Initial Decision: The State produced evidence through testimony and the Respondent produced evidence through testimony of witnesses that the Respondent made a mistake in his life and is coping with that mistake in an attempt to overcome his use of drugs and drug abuse. The Respondent moved on his own volition with the help of others to search out and take advantage of programs that would rehabilitate him with respect to overcoming ... drug abuse ... . The Hearing Officer was persuaded to consider any recommendations which were made by the Attorney for the Board in these matters due to the goodwill effort on behalf of the Respondent as well as the assistance and guidance that has been given to the Respondent b[y] said Respondent's present employer.... Exhibit No. 6 attached to Petitioner's Ex. No. 2. Georgia Discipline Following the hearing in Georgia and the initial decision of the hearing officer, the Georgia Board imposed a suspension of Dr. Pennington's license to practice pharmacy for six months, just as the hearing officer had initially decided. But further, again following the lead of the hearing officer's initial decision, the Board suspended enforcement of the suspension for two years during which Dr. Pennington was to be on probation with conditions. Among other conditions of the probation, Dr. Pennington was required to submit to random urinalyses and to attend professional aftercare treatment and counseling. The probationary period was set from December 1985 until December 1987. Medical School After being on probation for a period of eight months, Dr. Pennington, in August of 1986, entered a medical school in the Caribbean on the island nation of Grenada. Dr. Pennington requested the Board of Pharmacy that the conditions of probation be lifted while he was in medical school because of the difficulty in complying with them in Grenada. The request was granted. After his second year of medical school in Grenada, Dr. Pennington transferred to the Medical College of Georgia in Augusta, Georgia. While in medical school in Georgia, Dr. Pennington began working part-time as a pharmacist again. Dr. Pennington did not resume compliance with the conditions of probation imposed by the order of the Georgia Board of Pharmacy. As to its role in overseeing Dr. Pennington, the Georgia Board apparently simply lost track of his case. In any event, the Georgia Board did not follow up to ensure that Dr. Pennington had completed his probation successfully. Resumption of Drug Use During his third year of medical school, while working as a pharmacist again, Dr. Pennington began drinking. Before long, he was taking drugs from the pharmacy at which he was working for his own personal use, again without authorization from the pharmacy or a prescription. Following graduation from medical school, Dr. Pennington undertook his residency at the Ochsner Clinic in New Orleans. His drug use continued. But instead of taking drugs from a pharmacy inventory, Dr. Pennington opted for a method not subject to pharmacy inventories. He wrote prescriptions for them in the names of other persons. Access to More Powerful Narcotics as an Anesthesiologist Respondent began his residency in internal medicine but switched to anesthesiology. The switch was not helpful to Dr. Pennington in terms of controlling his addiction. Now, different drugs, often more powerful, were readily available to him. Among them was Sufenta. To narcotic addicts subject to monitoring who want to resume narcotic use, Sufenta is a drug of choice because it is difficult to detect in bodily fluids. Listed as a controlled substance under Schedule II, Section 893.03(2), Florida Statutes, Sufenta is used primarily for analgesia in surgery. In addition to eliminating physical pain, it produces feelings of well-being and stops emotional pain. It has an effect similar to hydrocodone but it is shorter-acting and much more potent. In fact, Sufenta is the most potent opiate used in medicine today. Dr. Pennington began using Sufenta while a resident in anesthesiology either by injecting it or by inhaling it nasally. His use of this extremely powerful narcotic continued throughout the first half of this decade. Application for Florida Licensure as an M.D. In July of 1993, Dr. Pennington's fiance, Rachel, (now his wife,) assisted him in filling out his application for licensure by the Board of Medicine. Just as Dr. Pennington's previous spouse and other family members had been unaware of his narcotic addiction while a pharmacist prior to entering medical school, Rachel Pennington, too, was unaware that Dr. Pennington was using narcotics. Moreover, she did not know of his past history of drug use or his discipline in Georgia. Rachel Pennington typed the application for Dr. Pennington. Questions 4, 9 and 10 on the application were these: Have you ever been notified to appear before any licensing agency for a hearing on a complaint of any nature, including, but not limited to, a charge or violation of the medical practice act, unprofessional or unethical conduct? Are you now or have you ever been addicted to or excessively used alcohol, narcotics, barbiturates, or any other medication? Have you ever voluntarily or otherwise been a patient in a hospital, institution, clinic or medical facility for the treatment of mental/ emotional illness, drug, addiction/abuse, or excessive use of alcohol? Although the correct answer to each of the three questions in Dr. Pennington's case is "yes," the answers he gave on the application to each were "no." Dr. Pennington reviewed and signed the application. At this moment of opportunity to reveal the truth to his fiancee, Dr. Pennington chose to continue to conceal his addiction and past history of both drug use and discipline. The falsified application was submitted to the Board of Medicine in November of 1993. During the hearing in this case, Dr. Pennington was asked on cross examination about his awareness that the application contained misrepresentations: Q You were aware at the time you filled out your licensure application that the answers to those three questions were incorrect, weren't you? A ... I don't think it is adequate to answer the question saying that because of my denial of the disease that I didn't know the question was wrong. I definitely, at some level, knew the question was wrong. Q ... You knew that you had been disciplined before?. A Yes. Q And you knew that you had been in a treatment facility before. A Yes. Q ... Did you consider that you were in a treatment facility because you were excessively using drugs? * * * A Well, I guess to answer that ... I have to say yes, at some level I definitely did. I was not willing to admit that but to answer your question I have to say yes. (Tr. 201). Practice in Florida and Continued Drug Use Dr. Pennington was licensed by the Board of Medicine on March 11, 1994. He continues to hold that license, license number ME 0065888. In June of 1994, Dr. Pennington completed his residency. Shortly thereafter, he moved to Florida to begin practice as an anesthesiologist. He continued to use narcotics. In order to stave off withdrawal symptoms, the onset of which can occur within several hours of using a powerful opiate like Sufenta, Dr. Pennington was forced to use narcotics throughout the day, including while at work. Moreover, he was unable from time-to-time to avoid the side effects of withdrawal, which included chills and diarrhea. To control those symptoms, he used drugs such as Lomotil. Lomotil, like Sufenta and the other opiates Dr. Pennington has used, requires a prescription. Self-prescribing and Fictitious Patients In order to obtain some of these drugs, Dr. Pennington wrote out prescriptions for Bob Pennington (his father), Rachel Pennington (his wife), and Kim Patrick (his ex-spouse), none of whom were patients of his. For example, between November, 1994, and February, 1995, he wrote or called in at least fourteen prescriptions for Hycodan, Lomotil and Tussionex, in the names of the three fictitious patients. In reality, the prescriptions were for himself. The Self-prescribed Medications Hycodan contains hydrocodone bitartrate, and is a Schedule III controlled substance under Section 893.03(3), Florida Statutes. It is used for cough-relief. The maximum recommended daily dose is 30 milliliters, or six tablets, which consists of thirty milligrams of hydrocodone. Tussionex contains hydrocodone polistirex, and is a Schedule III controlled substance under Section 893.03(3), Florida Statutes. It is used for cough relief and upper respiratory symptoms associated with allergies or colds. The maximum recommended daily dose is ten milliliters consisting of twenty milligrams of hydrocodone. Hydrocodone is a semisynthetic narcotic antitussive and analgesic with multiple actions qualitatively similar to those of codeine. It is a narcotic with potential, of course, for abuse. It has the potential for abuse because it is an opiate derivative, one that, attached to the morphine or opiate receptor in the brain, produces effects of somnolence and euphoria, as well as suppressing other nerve impulses. Hydrocodone causes one to feel good about oneself, blurs time relationships, and changes a person's perceptions. It can cause lack of attention or cause one to be easily distracted, traits that pose extreme danger to patients under the care of an anesthesiologist. Once a certain level of tolerance is reached with hydrocodone, it causes twitching, nervousness, diarrhea, flushing, chills, goosepimples, and other classic symptoms of narcotics withdrawal. Lomotil contains diphenoxylate hydrochloride, and is a Schedule V controlled substance under Section 893.03(5), Florida Statutes. It is used in the management of diarrhea, a common symptom of narcotics withdrawal. It is also used to control other symptoms of withdrawal such as pain and twitching. The maximum recommended daily dose of Lomotil is eight tablets a day or twenty milligrams. At high doses, it is addictive, causing codeine-like effects. Between November, 1994, and March, 1995, Dr. Pennington was taking approximately 15-20 hydrocodone tablets, that is, 75- 100 milligrams, per day, and 30 to 50 Lomotil tablets or 75 to 125 milligrams per day. These levels of consumption are three to five times the recommended maximum daily dosage. Dr. Pennington was self-administering these substances for several purposes: satisfying his addiction, fending of withdrawal symptoms and controlling withdrawal symptoms he could not avoid. Caught Again On March 24, 1995, Dr. Pennington was questioned by an official of the Drug Enforcement Agency (DEA) and a Pinellas County Sheriff's Office detective regarding the fourteen prescriptions for fictitious patients written in late 1994 and early 1995. The interview took place immediately after Dr. Pennington had completed administering anesthesia during an operative procedure on a patient. Dr. Pennington admitted writing the fraudulent prescriptions. Furthermore, he provided the officers with a syringe containing approximately one cubic centimeter of Sufenta. Dr. Pennington admitted that he had used Sufenta about two hours earlier before administering anesthesia to the patient. Talbott-Marsh On March 25, 1995, the day after the DEA discovered Dr. Pennington was illegally using narcotics, he was admitted to the Talbott-Marsh Recovery System in Georgia, having been referred because of his chemical dependency by the Physicians Recovery Network. An inpatient chemical dependency treatment facility, Talbott-Marsh is specifically designed to meet the treatment needs of chemically addicted health care professionals, especially physicians. Five months after admission, on August 25, 1995, Dr. Pennington was discharged from Talbott-Marsh. He had completed the program successfully. Once again, just as upon successful completion of the program at Willingway, Dr. Pennington was in recovery from the disease of chemical dependency. Addiction: the Disease of Chemical Dependency The Disease and its Stages Chemical dependency or addiction is a chronic illness. An identifiable disease recognized by the medical profession, it is not the result of voluntary behavior. Rather, it is the result of a biogenetic defect, one with which the addicted person is born. Together with introduction into the person's system of a sufficient amount of a mood altering substance, this defect produces addiction. Initially, the disease manifests itself in abuse of the drug. In this early stage, addiction has not yet occurred. As use recurs, however, at some point the person crosses the threshold of addiction. After addiction, the individual becomes more and more preoccupied with obtaining the drug, primarily to avoid withdrawal symptoms when the addiction is not satisfied. The more preoccupied the individual becomes with obtaining the drug, the more avoidance there is of external responsibilities: those related to family, work and self. The disease is characterized by the continued use of the drug in the face of ongoing adversity as the result of the avoidance of external responsibilities. Left untreated, the disease leads to serious consequences: institutionalization due to a number of factors which may include brain damage or uncontrollability, disability, and, in extreme cases, death. Crossing the Wall As the disease progresses, eventually it takes control of not only the individual's use of the drugs but all of the individual's thinking as well. This point is referred by practitioners of addictionology as "crossing the wall." When the addict crosses the wall, the disease is in control. It is not uncommon for an addict who crosses the wall to conceal the drug use from everyone including spouse, other family members, friends, and employers. It is common for an addict who has crossed the wall to lie about drug use and minimize the extent of its effects on the addict's life. The acts of denying, concealing, and lying about drug use are common manifestations of the disease of chemical dependency. They fall into a continuum of symptoms of the disease ranging from denial, which relates to the negative consequences the use is having on the addict, to lying. Physicians as Addicts It is common for physicians addicted to drugs to steal them, divert them, write prescriptions for their own use or engage in other deceptive means of obtaining drugs. The manner used by physicians to obtain drugs is often dependent upon the physician's specialty. Nonetheless, self- prescribing medications is found in almost all of the cases of addicted physicians. Consuming massive quantities of drugs is not unusual for the addicted physician, often, in part, because of ready access to drugs. It is, moreover, a sign of tolerance of the drugs. Even in cases of great consumption, and despite the characteristics of narcotics and opiates, when physicians develop tolerance, they remain able to function well while under the influence of the substance. It is common, therefore, for drug usage to go undetected for long periods of time. Furthermore, with regard to opiates and narcotics, it is often difficult to determine whether a person is using them. There tends to be much less muscular coordination, slurred speech and recent memory deficits as would be observed of persons under the influence of other drugs. An individual addicted to and under the influence of opiates, even a physician practicing in a specialty as demanding as anesthesiology, can appear to be functioning as well as a person not under the influence of drugs. This is the case, in part, because a person addicted to opiates can develop tolerance rapidly. The more powerful the opiate, the sooner tolerance may be developed, as in the case of Sufenta. A physician under the influence of Sufenta can take a massive dose and appear to be basically normal to the untrained eye. Dr. Pennington's Stage of Addiction at the Time of Application Prior to the fall of 1993, that is, the time when Dr. Pennington made out and submitted his application to the Board of Medicine, he exhibited all the symptoms of a person who has crossed the wall. He had concealed his drug use, which at that time had become quite advanced, from his fiancee, his family, friends, and colleagues. He was taking massive quantities of narcotic opiates, yet, to the untrained eye, he was not exhibiting symptoms of a person under the influence. At the time of application, Dr. Pennington was well- thought of by his colleagues in the residency program in Louisiana. He was highly recommended for licensure to the Board of Medicine by the instructors of his residency training program. Treatment, Care and Aftercare Treatment is an important phase of the recovery process. Those suffering chemical dependency generally do well in treatment because of the controlled and structured nature of the treatment environment. The environment is safe. The patient is surrounded by others with similar problems. There is a lot of support both from those suffering the disease as well as from professionals. A successful treatment program must insist that the patient be rigorously honest in order to attain full recovery. Rigorous Honesty Because lying is an integral part of the disease of chemical dependency, a program of recovery demands rigorous honesty. In an effective recovery program, such as the one Dr. Pennington participated in at Talbott-Marsh, the physician is required to face the consequences of addiction and participate in psychotherapy when needed. During the treatment phase, the physician is required to go through identification with the family, have a fourth and fifth step of identifying the history of past defects and telling them to another human being. The Physician Recovery Network The Physician Recovery Network is the program used by the Board of Medicine to monitor physicians impaired by addiction in the State of Florida under Section 455.261, Florida Statutes. The Physician Recovery Network ("PRN,") assists the physician in developing and maintaining a manner of living which demands rigorous honesty. PRN does this by requiring the physician to enter into an Advocacy Contract, a five year contract that can be extended if necessary. The Advocacy Contract is designed to serve as a deterrent, promote honesty, to verify through face-to-face conferences and monthly and weekly meetings and periodic urine screens, that a physician is progressing or improving and is not endangering the public or him or herself. Physicians are required to identify the consequences of their drug use and admit their powerlessness over their ability to stop using drugs. Rigorous honesty is demanded by PRN from its participants because it is absolutely required in order to break denial and to prevent rationalization and denial from returning to the behavioral patterns of the addicted physician. PRN educates physicians about the negative behavioral patterns of their disease and monitors the physicians for the return of erratic behavior or evidence of returning denial or evidence of lying. PRN educates physicians about their own indicators for relapse so that they avoid positions likely to produce relapse and so that they will not be unconsciously driven to resume drug use to relieve personal discomfort. PRN monitors its physician participants through local group facilitators. Monitors are assigned because of geographic proximity that will allow immediate access in order to provide counseling. Initially, the PRN monitor undertakes a direct physical evaluation of the physician and becomes familiarized with the physician's specific problems to allow early identification of developing problems that would endanger the public or the physician. In addition, the monitor maintains close contact with PRN. Reports to PRN are made at least weekly providing information about general progress, insight, attentiveness, responsiveness to urine screens, participation in group sessions, openness of the physician, assessment of honesty, and assessment of coping skills. The contact between the monitor and PRN is so comprehensive that it can be characterized as an ongoing dialogue about all aspects of the physician related to management of the addiction and the medical-legal implications for the physician's practice and protection of the public. The monitor is also charged with providing the participating physician with support. If a physician fails to comply with PRN instructions or relapses, the monitor immediately reports it to PRN so that the physician can be submitted to treatment. If necessary to protect the public in such a case, PRN does not hesitate to report the matter to the Agency for Health Care Administration for entry of an emergency order suspending the license. While some number below 20 percent of physicians who enter PRN require more than one treatment to become firmly committed to recovery, 97 percent of the physicians who enter PRN practice without difficulty after five years. The ninety-seven percent success rate PRN has experienced with addicted physicians is significantly higher than the success after treatment of the general population of sufferers of chemical dependency in returning to lives committed to recovery and free of the problems of addiction. Aftercare Aftercare, the stage of recovery which follows treatment and the diseased physician's entry into recovery, is an essential phase of the recovery process, every bit as important, if not more so, than the initial program of treatment. It must consist of close monitoring with repetitive follow-up. This is provided by PRN. As an aftercare program more highly developed than the aftercare received by Dr. Pennington from Willingway in the previous decade, in part, due to advances in the study of addictionology, PRN provides the type of aftercare that supports recovery as fully as possible in light of the status of addictionology today. For example, the syndrome of "protracted withdrawal from opiates," was not even known to exist at the time Dr. Pennington participated in the Willingway program. The syndrome is the result of the body shutting off its own, natural, manufacture of endorphins and other "internal opiates," necessary to a sense of well-being while taking narcotic opiates and introducing into the body exogenous opiates. As a result, it takes the body several years, a period longer than the initial treatment phase, to begin producing its own internal opiates. In the meantime, the opiate addict will continue to suffer withdrawal symptoms, hence the term "protracted" withdrawal. Unlike the care after the Willingway program, the PRN aftercare program provides treatment for protracted withdrawal. Dr. Pennington's Experience with PRN and Adherence to the Advocacy Contract At least through the time of hearing, Dr. Pennington has maintained a strict adherence to his PRN contract. He has fully complied with monitoring by PRN. He has shown a significant commitment to his program of recovery since entering into the advocacy contract. Since late summer, 1995, PRN has considered Dr. Pennington to be safe to practice under the terms of his advocacy contract with continued monitoring. In making that determination, PRN has considered all of the Respondent's past addictive behavior including the length of his addiction, his ability to function normally while under the influence of opiates and other drugs, lying about drug use, concealing it from family, friends, work colleagues, even the Board, stealing drugs, and self-prescribing. Moreover, PRN has considered his prior discipline by the Georgia Board of Pharmacy, the treatment at Willingway and the failed aftercare in his first effort at recovery. Most importantly, PRN has considered the potential danger Dr. Pennington poses to patients and the public. Because of restrictions imposed upon him by both Talbott-Marsh and PRN, Dr. Pennington is not practicing as an anesthesiologist. He cannot resume that practice until his treatment professionals and PRN agree that it is safe for him to do so. Dr. Pennington is not permitted access to controlled substances. He must utilize triplicate prescriptions, one for the patient, one in the chart, and the other for monitoring. Since leaving Talbott-Marsh, Dr. Pennington has successfully met these requirements imposed for his aftercare from the moment he left Talbott-Marsh: Monitor and addictionologist: Dr. Roger Goetz and a local monitor, Jim Noyes, Ph. D. Primary physician of Marte Kautzler, D.O. Not to return to anesthesiology for at least one year following treatment. Return to Talbott-Marsh for reassessment. Work 40 hours per week maximum. Utilize triplicate prescription pads in his practice. Reside with wife, Rachel, and attend couples therapy as directed by Dr. Noyes. Attend Caduceus and AA, 90 meetings in 90 days, followed by attending at a frequency of four to seven times per week. See Joint Exhibit 1. Board Action Had it Been Aware of the Truth at the Time the Application Was Filed Had the Board been aware at the time Dr. Pennington filed his application that the answers to questions 4, 9 and 10 were inaccurate, Dr. Pennington would have had to appear before the Board's Credential Committee. The Committee would have required a personal appearance of Dr. Pennington and a PRN evaluation. Based on the evaluation and Dr. Pennington's explanation for the inaccuracies in the application, the Committee would have recommended either denial of licensure or issuance of the license. Dr. Pennington is in full compliance with his PRN contract and has demonstrated a strong commitment to his program of recovery and the requirements of PRN. It is likely, based on an analysis of similar cases, that if Dr. Pennington were to apply for a license today, with full disclosure, and under the current circumstances of his good standing in the PRN program, that the Board would grant him a license with conditions. Dr. Pennington's Practice Today Today, Dr. Pennington is employed as a practicing physician at a private walk-in clinic. In addition to the practice of requiring his prescriptions in triplicate, his access to controlled substances is completely restricted and the restriction is closely monitored. The nurses at the clinic maintain the keys which allow access to the drugs. An inventory is conducted in the morning when the facility opens and is matched every day with an inventory done in the evening when the facility closes. A urinalysis to check for recent drug use was performed when Dr. Pennington was hired and random urinalyses are done of all employees, including the owner, from time to time without warning. Dr. Pennington, at the time of hearing, had been subject to two urinalyses. Dr. Pennington is observed at the facility for behaviors that would indicate relapse. At the time of hearing, he had not exhibited any such behaviors. His knowledge of medicine was described by his employer as good. Moreover, Dr. Pennington has shown good clinical judgment in the cases he has encountered as well as excellent skills in dealing with his patients. The Impact of Discipline on Dr. Pennington It would be counter-therapeutic to Dr. Pennington to remove him from the practice of medicine while he is in recovery. In fact, one of the main reasons for the extremely high success rate of PRN's work with physicians suffering from the disease of chemical dependency when compared to the general population of those with the disease, is that the physician is working and his or her license is always at stake. Protection of the Public The department, in an attempt to protect the public, is seeking discipline of Dr. Pennington. Yet, the Board, by not taking emergency action against his license, has conceded that he is not impaired at the moment and so long as he is in recovery. Moreover, by allowing his practice pending this proceeding and not taking emergency action against his license, the Board has determined Dr. Pennington's practice as a physician in a walk-in clinic does not pose an imminent danger to public health safety and welfare.
Recommendation Based on the foregoing, it is, hereby, RECOMMENDED: That Dr. Pennington's license to practice medicine be suspended for five years; That the suspension be stayed and that he be placed on probation immediately for at least five years with probation to be extended, if necessary at the end of the five years; That appropriate conditions of the suspension be imposed by the Board to include, at a minimum: No practice of anesthesiology during the period of probation; No access to controlled substances, drugs or medicines requiring a prescription during the period of probation; and, Participation in the Physician's Recovery Network for the entire period of probation. DONE AND ENTERED this 22nd day of November, 1996, in Tallahassee, Leon County, Florida. DAVID M. MALONEY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 22nd day of November, 1996. COPIES FURNISHED: Monica Felder, Esquire Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399 Grover C. Freeman, Esquire Jon M. Pellett, Esquire Freeman, Hunter & Malloy 201 East Kennedy Blvd., Suite 1950 Tampa, Florida 33602 Dr. Marm Harris Executive Director Agency for Health Care Administration Board of Medicine 1940 North Monroe Street Tallahassee, Florida 32399-0792
Findings Of Fact The Home is licensed as an assisted living facility. It is also licensed to provide extended congregate care, limited nursing services, and limited mental health services. The Home accepted Respondent as a resident. In July 1998, Petitioner had to transport Respondent to the hospital due to an overdose of medication. Upon his return from the hospital, Respondent told Petitioner's staff that he had taken the overdose intentionally. Thereafter, the Home required Respondent to sign a mental health contract dated September 9, 1998. This contract states as follows in relevant part: Qualifications for the Home requires [sic] that a member or applicant must not be mentally ill, habitually inebriated, or addicted to the use of a controlled substance. With these requirements, I understand that to be eligible and maintain my membership in the Home, I must agree to the terms of this contract. * * * If I use alcohol or any non-prescribed drugs I understand I may be dismissed from the Home. I understand that I will allow the Veterans' Domiciliary Home of Florida to supervise the self-administering of my medications. I will take my medication as it is prescribed by the primary physician. I will only be given my full prescription at the time of my discharge. I understand upon reasonable suspicion of being under the influence of alcohol or illegal drugs, I consent to testing. The Domiciliary Home staff may take a blood, saliva, or supervised urine sample to test for illegal drugs or alcohol. I authorize members of the Domiciliary staff to perform random searches of my person, vehicle, living quarters, or belongings to determine if I am using drugs or alcohol. If I refuse to allow a blood, saliva, or urine test, or search, or if I interfere in any way with the staff's performance of these duties, I may be dismissed. The Home also required Respondent to sign a Dual Diagnosis/Substance Abuse/Psychiatric (dual diagnosis) contract dated September 14, 1998. In addition to terms and conditions similar to the ones set forth above, the dual diagnosis contract provides as follows in relevant part: 10. In order to assist me in gaining freedom from alcohol and drugs, I will not use alcohol, tranquilizers, sleeping medication, over the counter medications, or any other chemical escapes which have not been prescribed by a physician. If I use alcohol or non-prescribed drugs, I understand I will be dismissed from the Home. In November 1998, one of Respondent's doctors wrote him a prescription for Ritalin. Respondent became very upset when a nurse would not administer the Ritalin to him without first checking with Petitioner's staff physician. Eventually, Respondent's primary care physician approved the administration of Ritalin together with Respondent's other medications. In January 1999, Respondent worked for Petitioner as a receptionist. After working overtime on one occasion, Respondent's speech was slurred, his eyes were dull, and his voice was horse. Petitioner's staff became suspicious that Respondent was taking medication in violation of his contracts. Respondent subsequently tested negatively for all substances except his prescribed medicines. In March 1999, Respondent violated his contracts by having a prescription for methadone filled at a drugstore and removing twenty-four of the pills from the bottle before turning the medicine over to Petitioner's staff as required by his contract. Petitioner's staff advised Respondent that he would be dismissed from the Home by letter dated March 23, 1999. Respondent subsequently requested Petitioner's Executive Director to review the decision to discharge him from the Home. By letter dated August 16, 1999, Petitioner rescinded its decision to dismiss Respondent from the Home but warned him that any further infraction would result in his immediate expulsion. On April 14, 2000, Petitioner conducted a routine facility-wide room inspection at the Home. During the course of the inspection, Petitioner found a bottle of Ephedra 250 in Respondent's room. According to the label on the bottle, Ephedra 250 is a dietary supplement that General Nutrition Corporation (GNC) markets. During the hearing, Respondent admitted that he heard about Ephedra 250 on a television show that discussed its benefits as a diet aid as well as its dangerous side effects. The label states as follows in pertinent part: WARNING: Seek advice from a health care practitioner prior to use if you are pregnant or nursing, or if you have high blood pressure, heart or thyroid disease, diabetes, difficulty in urination due to prostate enlargement, or if taking MAO inhibitor or any other prescription drug. Reduce or discontinue use if nervousness, tremor, sleeplessness, loss of appetite or nausea occur. Not intended for use by person under the age of 18. The maximum recommended dosage of Ephedrine for a healthy adult is no more than 100 mg in a 24 hour period for not more than 12 weeks. Improper use of this product may be hazardous to a person's health. Each capsule of Ephedra 250 contains 250 mg of MA Huang Extract (Ephedra sinica) or ( 15 mg of 6 percent Ephedrine). The greater weight of the evidence indicates that Ephedra 250 is an over-the-counter medication despite being labeled as a diet supplement. Ephedrine is a prescription drug in Florida unless an individual dose is less than a specified quantity. Petitioner's staff properly became concerned about Respondent's possession of Ephedra 250 because he takes numerous prescribed medications, which can have serious side effects, if taken with certain other medications. Ephedrine is one of those drugs. For instance, Respondent takes Cozaar for high blood pressure, Methadose to reduce his dependency on Percoset, and Ritalin. Persuasive evidence indicates that large doses of Ephedra can be used as a recreational drug. Respondent knew or should have known that Ephedra 250 was prohibited by his contracts with the Home.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED: That Petitioner enter a final order dismissing Respondent as a resident of the Robert H. Jenkins Veterans' Domiciliary Home of Florida. DONE AND ENTERED this 6th day of October, 2000, in Tallahassee, Leon County, Florida. SUZANNE F. HOOD 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 6th day of October, 2000. COPIES FURNISHED: James W. Sloan, Esquire Department of Veterans' Affairs Post Office Box 21003 St. Petersburg, Florida 33731-8903 William T. Fisher 1300 Sycamore Lane, Suite 148 Lake City, Florida 32025 Lt. Col. Robin L. Higgins, Executive Director Department of Veterans' Affairs Post Office Box 31003 St. Petersburg, Florida 33731-8903
Findings Of Fact The parties stipulated that Monroe C. Schiffman is a pharmacist licensed by the Florida Board of Pharmacy. They further stipulated that Sharon Drugs, d/b/a Mercy Professional Building pharmacy is located at 3661 south Miami Avenue, Miami, Florida and that Sharon Drugs owns and operates Mercy Professional Building Pharmacy. The parties also stipulated that Monroe C. Schiffman was a corporate officer and share holder in Sharon Drugs, Inc., a Florida corporation, from February 1, 1975 until the dates of the audits in question and that Monroe C. Schiffman was a corporate officer and stockholder in Monroe Pharmacy, Inc. from March, 1974, until the audits in question. An inspection and audit of Sharon Drugs, Inc. d/b/a Mercy Professional Building Pharmacy, was begun on April 23, 1976 and lasted for several days. The audited period was from March 17, 1975 until April 26, 1976, during which dates Monroe C. Schiffman was the registered pharmacist for the operation of Sharon Drugs, Inc. The procedures for the audits were to assume a zero stockage as of March 17, 1975 and to account for the drugs received after that date. The drugs audited were controlled drugs as defined by Chapter 893, Florida Statutes. These drugs were chosen for audit because complete records of their order, receipt and dispensing must be kept pursuant to Chapter 893, Florida Statutes. Exhibit 1, a summary of the audit of Sharon Drugs, Inc., was identified by the Board's agent, Vernon K. Bell, as the summary of the discrepancies in controlled drugs revealed by the audit which he conducted. The audit conducted by Vernon K. Bell revealed a shortage of controlled drugs for which no records had been kept of 296,481 total units or pills. The drugs audited were Desoxyn (methamphetamine hydrochloride), Tuinal (sodium amobarbital and sodium secobarbital), Biphetamine (d- and dl-Amphetamine), Dilaudid (hydromorphone), Nembutal (sodium pentobarbital), Seconal (sodium secobarbital), Quaalude (methaqualone), Eskatrol Spansule (dextroamphetamine sulfate and prochlorperazine) , and Dexedrine (dextroamphetamine sulfate). Monroe C. Schiffman, while the registered pharmacist at Mercy Professional Building Pharmacy, did not keep the record required to be kept by law.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, the Hearing Officer recommends that the license and registration of Monroe Charles Schiffman be revoked. DONE and ENTERED this 5th day of January, 1977, in Tallahassee, Florida. STEPHEN F. DEAN, Hearing Officer Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Michael Schwartz, Esquire Suite 201, Ellis Building 1311 Executive Center Drive Tallahassee, Florida 32301 Gerald Kogan, Esquire Suite 500 Security Trust Building 700 Brickell Avenue Miami, Florida 33131 H. F. Bevis, Executive Secretary State Board of Pharmacy 252 East Sixth Avenue Box 3355 Tallahassee, Florida 32303
