Findings Of Fact Rainbow (herein sometimes Respondent) began operations as a methadone treatment center (outpatient methadone program) on May 15, 1988, with a probationary license for 90 days granted by the Petitioner, Department of Health and Rehabilitative Services. All methadone treatment programs begin operations with a probationary license. Methadone is a classified Schedule II narcotic drug, a synthetic opiate, manufactured in a pharmaceutical laboratory. It is highly addictive and for that reason, it is closely monitored and controlled by the Federal Drug Enforcement Administration, can only be dispensed and administered by authorized medical personnel and the authorized dispensers of methadone are required to maintain strict security of access to methadone. Respondent's operation is a drug abuse treatment and prevention program (DATAP) and is defined as such and governed by Chapter 397, Florida Statutes. Respondent's program is designed to assist its clients, particularly the heroin addict or someone who is taking the synthetic opiate Dilaudid, a popular street drug, to take the client "off the street," and give them a stabilizing dose of methadone so that they can return to a more fully functional and responsible life style. That is accomplished by first stabilizing the client on a dose of methadone which is acceptable to them physically and provide treatment planning and auxillary services to assist them in restructuring their life style. The goal of the program is to reduce the methadone a client receives with the ultimate idea of making the addict drug free. On July 13-14, 1988, Petitioner dispatched a technical team to inspect Respondent's program. The inspection team consisted of Phil Highman, Sr., Human Services Program Specialist, Anton Krone, M. D., Mark Engelhardt, Program Supervisor - HRS District VI, and Gail Potter, Senior Human Services Program Analyst. Respondent's President, Angela Duncan, was present along with Lois Knoffler, R. N., Nursing Supervisor and Barbara Reszac, L. P. N. Following the inspection, an exit conference was held on July 14, at which time the inspection team advised Duncan of numerous clinical and medical standard deficiencies which were not being complied with. The inspection team found that Respondent's problems were due principally to a lack of knowledge regarding addiction and methadone treatment and a general laxness in implementing and documenting service provisions. On the clinical side there was no evidence to suggest that charts were being reviewed on a consistent, regular basis to ensure that specific treatment activities were in compliance with Chapter 10E-7, Florida Administrative Code, and on the medical side, the Medical Director exhibited little experience in the addiction field and the services provided were minimal at best. Also, the Medical Director was not spending adequate time at the clinic. The following programmatic elements were in noncompliance with regulations and required corrective action. In the clinical area these were: An absence of a psycho-social assessment including a clinical summary of each record within 10 days of admission to out-patient maintenance treatment as required by Section 10E-7.039 (a)(g), Florida Administrative Code. Respondent's failure to provide signed credentialed and dated, psycho-social assessments for each client as required by Section 10E-7.032(18)(g), Florida Administrative Code. An absence of individualized treatment plans developed for each patient within 30 days of admission to include measurable goals and objectives and the type and frequency of services required and properly signed, credentialed and dated. Sections 10E- 7.032(28)(b) and 10E-7.039(3)(j)2., Florida Administrative Code. An absence of recorded progress notes in the case records in accordance with the frequency of counseling. Sections 10E- 7.039(3)(j)1 and 3, Florida Administrative Code. A failure to place on phase one, all persons admitted, readmitted or transferred to maintenance treatment absent an authorized exception. Sections 10E-7.039(3)(d)6. and 10E-7.039(3)(e), Florida Administrative Code. Failure to document that clients who violated clinical rules such as illicit drug use and absenteeism had received disciplinary actions appropriate to the nature of the violation. Section 10E-7.039(3)(h), Florida Administrative Code and Sections 291.505 (d)(8)(v), (b) and (1), Code of Federal Regulations. In the medical area the following deficiencies were noted: A failure to document that the program physician conducted a physical exam prior to administration of the initial dose of methadone absent a documentable emergency. Section 10E-7.039(2)(f)2., Florida Administrative Code. A failure to document that all physical exams con formed to the medical services requirements prescribed under Sections 10E- 7.034(1)(a) and 10E-7.039(2)(F), Florida Administrative Code. A failure to provide results of a laboratory test which is required on each patient at the time of admission. Section 10E-7.039 (f)(1), Florida Administrative Code. Failure to document that the program physician thoroughly documented each patient's current addiction and history of addiction before administering the initial dose of methadone. Sections 10E-7.039(2)(f) 5.A. and 10E-7.039(3)(a)1.-3., Florida Administrative Code. Failure to document that each patient had signed the "consent to methadone treatment" form prior to being administered the initial methadone dose. Section 291.505(d)(1)(ii), Code of Federal Regulations. A failure to document that the program physician signed or countersigned, within 72 hours, all orders relative to medication and take-home privileges. Sections 10E- 7.039(2)(f)5.d-f, Florida Administrative Code. On August 15, 1988, Petitioner advised Respondent of the non- compliance of the above-referred clinical and medical standards and by that notification, extended Respondent's first probationary license 45 days through September 27, 1988 to allow Respondent an opportunity to correct the deficiencies; placed a moratorium on admissions of new clients beginning August 14, 1988, and advised of its serious concern with the deficiencies with Petitioner's then consideration of denying Respondent a regular license. Respondent was further advised that Petitioner would continue to monitor Respondent's activities during the probationary period. Petitioner's moratorium limited Respondent to 49 clients. On August 30, 1988, Petitioner again dispatched an inspection team to Respondent's facility to monitor compliance. Petitioner's attendees were the same attendees who made up the earlier inspection on July 13-14, 1988. Administrator Duncan was present along with clinical supervisor, Bob Brouck and Clifford Frost, counselor. On the day of inspection there were 49 clients in treatment in keeping with the moratorium and current staff/client ratio was within acceptable standards. In the clinical area, the team reviewed 14 clinical records and while there were psycho-social assessments available in all case records, in 11 of 14 cases assessments had not been completed within the required 10 days of admission. In the area of treatment plans, plans were available in 13 of 14 cases. In two cases, plans were not completed within the required 30 days of admission and in none of the cases reviewed, was the information provided delineating the type and frequency of services to be provided. In the area of progress notes, improvement was shown in terms of content but in 12 of 14 cases, notes were not recorded with the proper frequency according to client phase level. Also, in 5 of 14 cases, urine drug screens indicated that the clients in question were involved in illicit drug use and no reference to these incidents were made in the progress notes. In the medical area, a total of 7 medical charts were reviewed. In the area of physical exams, in only 2 of 7 cases were physicals completed prior to administering the initial dose of methadone. In the remaining cases, physicals were either unavailable, undated or not completed within the required time frame. Laboratory tests were available in 6 of 7 cases. However, in only one of the six cases was the test completed upon admission. In one case the lab was unable to draw blood from the client because of difficulty in locating a vein. In all cases reviewed, there was adequate documentation of the client's current addiction. In the phasing and take-out privileges area, it was difficult to determine each client's phase level from the clinical records; however, an examination of dosing records indicated that patients were participating on the proper phase level according to time and treatment. Respondent's program was out of compliance in the following clinical areas: Psycho-social assessments were not completed within 10 days of admission as required. Individualized treatment plans were not developed within 30 days of admission and no reference was made to the type and frequency of services to be provided. Progress notes were not recorded in case records with proper frequency according to phase level and, Illicit drug use had not been addressed relative to appropriate disciplinary action. In the medical area, the following deficiencies were noted: Physical exams had not been conducted prior to the administration of the initial dose of methadone. Physical exams did not conform to the medical service requirements prescribed under Sections 10E-7.034(1)(a) and 10E-7.039(2)(f)1 Florida Administrative Code. Laboratory tests had not been conducted at the time of admission. See Section 10E- 7.039(2)(f)1, Florida Administrative Code. At that time, Petitioner extended Respondent's second probationary period for a full 90 days, i.e. from August 14, to November 11, 1988, to allow Respondent time to correct the noted program deficiencies and items of non- compliance with rules and regulations which were cited by the inspection team. On September 29, 1988, Petitioner's agents Emenheiser and Moffett again inspected Respondent's program to determine compliance with the moratorium on new clients. At approximately 9:30 a.m. on September 29, Emenheiser and Moffett went to Rainbow, knocked on the door and were admitted by Respondent's counselor, Clifford Frost whom Emenheiser met at the previous inspection visit. Respondent's operating hours were 6 o'clock a.m. to 2 o'clock p.m., seven days a week. Rainbow was open for business to administer and dispense methadone. At the time of their arrival, there was a client in Respondent's waiting area talking with Frost. Inspectors Emenheiser and Moffett asked Frost for entry into the methadone dispensing area and inquired as to the whereabouts of Administrator Duncan and the dispensing nurse. Neither were at the clinic. Frost left the area and obtained the key to the dispensing area and unlocked the dispensing room. At the time, there were no medical personnel in the facility. Counselor Frost is not a medical person nor is he authorized to enter the dispensing room or to dispense methadone. The inspectors, after gaining entry to the dispensing area by Frost, found the dispensing room safe open with a telephone cord draped between the safe door and the body of the safe. In the open safe they found a full bottle of methadone and a box with 4 full bottles next to it. On the dispensing room counter, the inspectors found a bottle with about two inches of methadone in it and a pipette dispenser in its top and a take-out bottle with a small amount of methadone. Emenheiser and Moffett observed the medication record which contained signed entries initial led in advance. While in the dispensing room, Inspectors Emenheiser and Moffett observed another client come into the facility and Frost administered the take- out bottle of methadone to the client in the dispensing room. The take-out bottle was prepared in advance by Frost. In this regard, Frost stated that he did not do that sort of thing very often. Based on the inspectors observance of the access by an unauthorized person to obtain entry into the storage area where the liquid methadone was stored, the absence of medical personnel at Respondent's premises during the period of time when the facility was open for business to dispense and administer methadone, the dispensing and administration of methadone to a patient by an unauthorized employee, and the general lack of security in the area where the methadone was stored, Petitioner's agents called the Federal Drug Enforcement Administration (DEA) to report their findings and the events they had witnessed. After confirming that these were security violations, the inspectors left the facility immediately to consult with their superiors. The inspectors later provided affidavits detailing their findings and provided assistance in drafting the administrative complaint and the emergency final order. Respondent was ordered to cease and desist all operations of its DATAP program effective at 5 o'clock p.m. on October 10, 1988. Clifford Frost, Respondent's counselor, gave testimony and maintained, via deposition, that he allowed Petitioner's agents access to the storage area where methadone was kept based on prior conversations that he had with Emenheiser to the effect that if he (Frost) would help him close down Respondent's program, he (Emenheiser) would help Frost get another job. Frost maintains that he was being led by Emenheiser to shut down Respondent's facility and that he did so in an effort to go along with Emenheiser's wishes. Emenheiser denied having any motivation to shut down Respondent's program and as a long term career veteran with Petitioner's DATAP programs, the absence of any bias having been shown by Respondent, Emenheiser's testimony is credited. Frost's testimony is not credited to the extent that his testimony differs from the versions of events found herein and as testified to by employees Phillip Emenheiser, Harry Moffett and Gail Potter.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that Petitioner enter a final order revoking Petitioner's probationary license to operate a methadone treatment center. DONE and ENTERED this 26th day of July, 1989, in Tallahassee, Leon County, Florida. JAMES E. BRADWELL 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 26th day of July, 1989. APPENDIX TO RECOMMENDED ORDER CASE NO. 88-5518 Rulings on Petitioner's Proposed Findings of Fact Paragraph 9, rejected as conclusionary. Paragraphs 10 and 11, adopted as modified, last sentence in paragraph 23, Recommended Order. Paragraph 12, adopted as modified, paragraphs 11 and 15, Recommended Order. Paragraph 13, adopted as modified, paragraph 23, Recommended Order. Paragraph 14, adopted as modified, paragraph 10, Recommended Order. Paragraphs 15, 16, 17 and 18, adopted as relevant, paragraphs 11-14 and 24, Recommended Order. The remainder rejected as irrelevant and/or unnecessary. Paragraph 19, adopted as modified, paragraph 14, Recommended Order. Paragraph 20, adopted as relevant, paragraphs 15-17, Recommended Order. Paragraph 21, rejected, irrelevant. Paragraph 22, adopted as modified, paragraphs 19 and 20, Recommended Order. Paragraph 28, rejected, irrelevant. Paragraph 29, adopted as modified, paragraph 23, lines 16-21, Recommended Order. Rulings on Respondent's Proposed Findings of Fact Paragraph 1, adopted, paragraph 1, stipulated facts and paragraphs 1 and 18, Recommended Order. Paragraph 2, adopted, paragraph 4, stipulated facts. Paragraph 3, adopted as modified, paragraph 19, Recommended Order. Paragraph 4, first sentence, adopted and second sentence rejected based on contrary findings in paragraph 20, Recommended Order. Paragraph 5, rejected based on contrary findings in paragraph 24, Recommended Order. Paragraph 6, rejected as unnecessary to resolve the issues posed. Paragraphs 8-12, rejected based on contrary credibility resolutions stated in paragraph 24, Recommended Order. Paragraph 13, adopted as modified, paragraph 23, Recommended Order. Paragraph 14, rejected based on contrary findings in paragraph 23 to the effect that Frost was unauthorized to dispense and administer methadone. Paragraph 15, rejected as argument. Paragraph 16, rejected as irrelevant based on the determination in paragraph 23 to the extent there was a general lack of security in the storage of methadone and that such lack of security was in violation of the security requirements of a scheduled, highly addictive drug. Paragraph 17, rejected as argument. Paragraph 18, rejected based on contrary findings in paragraph 23 and the general lack of security by Respondent at the treatment center. Paragraph 19, rejected as irrelevant. Paragraphs 21 through 23, rejected, irrelevant and not probative of the issues posed. COPIES FURNISHED: Jack Farley, Esquire Department of Health and Rehabilitative Services 400 W. Buffalo Avenue 5th Floor, Room 500 Tampa, Florida 3361 Amelia M. Park, Esquire and William M. Park, Esquire 8001 North Dale Mabry Highway Building 601, Suite B Tampa, Florida 33614 Sam Power, Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Building One, Suite 407 Tallahassee, Florida 32399-0700 John Miller, Esquire Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 Gregory L. Coler, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700
Findings Of Fact The Petitioner, Department of Professional Regulation, Board of Pharmacy, seeks to take disciplinary action against Respondent based on its complaint filed February 24, 1982. Respondent, Herbert Lazarus, is a licensed pharmacist in the State of Florida and is holder of license number 5426. During times material herein, Respondent was employed at Don's Discount Drugs, 6234 S. Dixie Highway, South Miami, Florida. Respondent was the managing pharmacist of Don's Discount Drug Pharmacy Department throughout his employment and particularly during the period October 23, 1981 through January 6, 1982. The Drug Enforcement Administration, Department of Justice, conducted two audits to determine the quantities of Methaqualone dispensed from Don's Discount Drugs. The initial audit covered the period August 4, 1981 through October 23, 1981. The second audit covered the period October 23, 1981 through January 6, 1982. The first audit revealed that during the period August 4, 1981 through October 23, 1981, Don's Discount Drugs dispensed 68,738 300 milligram tablets of Methaqualone on 1,114 prescriptions. The second audit revealed that during the period October 23, 1981 through January 6, 1982, Don's Discount Drugs dispenses 133,667 Methaqualone 300 milligram tablets on 3,081 prescriptions from 6 physicians writing 2,241 of those prescriptions. The dosage appearing on more than 90 percent of the prescriptions relating to both audit periods is 45 units per prescription. The audit further revealed that the Methaqualone prescriptions constituted over 95 percent of all Schedule II prescriptions and more than one half of all prescriptions filled at Don's Discount Drugs. During times relevant herein, Methaqualone was a Schedule II controlled substance by virtue of statutory categorization in Section 893.03(2)(a)(4)(c)(5), Florida Statutes (1981). As such, Methaqualone is a substance which has a high potential for abuse and has severely restricted medical use. Abuse of Methaqualone leads to severe psychological or physical dependence. Methaqualone was designed to induce sleep. The drug generally should not be utilized for more than a period of three (3) weeks. (Testimony of John B. Handwerker, M.D.) Louis Fisher, a trained pharmacist, received his Bachelor of Science degree in Pharmacy from Hamden College of Pharmacy in Massachusetts. During the past eleven years, he has been a Federal Drug Enforcement Administration agent whose primary responsibility is to investigate pharmacists who handle and dispense Schedule II substances. Additionally, Mr. Fisher participated in the drafting of regulations that are now part of the federal Controlled Substances Act. Mr. Fisher was tendered and received as an expert herein in pharmacy. Mr. Fisher was presented with a hypothetical question encompassing the facts as presented herein respecting the dispensation of Methaqualone by the Respondent as managing pharmacist for Don's Discount Drugs during the period October, 1981 through January, 1982. Utilizing those facts, Mr. Fisher opined that such a managing pharmacist who permits the dispensation of Methaqualone in the amounts as described herein above would amount to the dispensing of Methaqualone in a manner outside the course of the professional practice of pharmacy; in a manner not in the good faith practice of pharmacy; in a manner considered to be excessive and inappropriate in the practice of pharmacy and not in good faith in dispensing those amounts of Methaqualone. An examination of one of the medical doctors who was prescribing the drug Methaqualone, was one Camila Dwyer, a stress clinic doctor. A review of Dr. Dwyer's prescribing patterns reveals that on an average day during the period during late December, 1981, Dr. Dwyer prescribed an average of 20 prescriptions which were tendered to be filled by Respondent at Don's Discount Drugs. The average prescription was for a quantity of 40 tablets of 300 milligram Methaqualone tablets. Mr. Fisher reviewed the prescribing pattern of Dr. Dwyer and expressed his opinion that Respondent, as managing pharmacist for Don's Discount Drugs, should have become alerted and inquired into Dr. Dwyer's prescribing practices since, in his opinion, the prescriptions were of doubtful origin and should have been refused by the Respondent and/or the filling pharmacist. Dr. John B. Handwerker, M.D. is a doctor who has practiced as such in Florida in excess of 31 years. Dr. Handwerker attended the University of Tennessee School of Medicine and trained at Jackson Memorial Hospital, Miami, Florida. Dr. Handwerker is an Assistant Professor of Clinical Pharmacology at the University of Miami Medical School. Dr. Handwerker was tendered and received herein as an expert in the dispensing of Schedule II drugs and in pharmacology. The recommended dosage for Methaqualone is 300 milligrams at bedtime used to induce sleep for a period not to exceed two to three weeks. This time period is used inasmuch as the effectiveness of the drug ceases following an approximate period of two weeks due to the pharmacological makeup of Methaqualone. Dr. Handwerker was also requested to review the prescribing patterns of Dr. Camila Dwyer. (Petitioner's Composite Exhibit 2) Dr. Handwerker determined, after reviewing Dr. Dwyer's prescribing pattern, that Dr. Dwyer's prescriptions should not have been accepted by the managing pharmacist at Don's Discount Drugs due to her abnormal prescribing pattern which should have been reported to the appropriate regulatory authorities. Methaqualone, a known street drug, is highly abused in south Florida. It is incumbent upon a pharmacist to question a doctor's prescribing patterns for drugs which are known to be abused. Jacob Hodus, a registered pharmacist since June, 1951, is an equal partner in Sandy's Drug, Inc., North Miami Beach, Florida. Mr. Hodus has practiced at Sandy's Drugs in excess of 28 years. Mr. Hodus was tendered and received as an expert herein in the practice of pharmacy in Florida. Mr. Hodus reviewed the prescribing patterns of the doctors who had prescribed Methaqualone and presented to Don's Discount Drugs to be filled. Based on what Mr. Hodus considered to be a pharmacist's obligation to report questionable prescribing practices to the appropriate regulatory agencies, he expressed the opinion that the Respondent, as manager of Don's Discount Drugs, should not have continued to fill the prescriptions for Methaqualone and that for him to continue to do so would not be either acting in the normal course of the professional practice of pharmacy or in the good faith practice of pharmacy. The Respondent's Position Herbert Lazarus, Respondent herein, is a registered pharmacist who has practiced that profession since 1947. Respondent has worked for numerous hospitals and drug stores and is presently still employed at Don's Discount Drug Store. At one time, Respondent owned Shadowlawn Pharmacies, but sold it due to medical problems. Respondent has served as the Chief Pharmacist at several hospitals including Victoria Hospital. From the period August 25, 1981 through May 3, 1982, Respondent served as a pharmacist for Stuart Levine, the former owner of Don's Discount Drugs. Respondent gave conflicting testimony as to the time that he became the manager of Don's Discount Drugs. At one point in his testimony, Respondent states that he became manager during mid-December, 1981 while, on other occasions, he testified that he became manager during January, 1982. Respondent avers that he was only a pharmacist employee and that all policy decisions respecting whether or not Methaqualone prescriptions should be filled were made by Stuart Levine. 2/ Stuart Levine expired on May 3, 1982. Thereafter, Respondent changed the policy of filling prescriptions for Methaqualone. It was noted, however, in this regard, that as of July 1, 1982, Methaqualone became a Class I drug and, therefore, is no longer sold in retail pharmaceutical outlets. Respondent expressed his belief that a pharmacist, in general, has no obligation to question a physician's prescribing practices. Respondent considered his primary responsibility to be that of verifying whether or not the prescription was, in fact, completed by a duly licensed physician authorized to dispense Schedule II drugs and whether that person presenting the prescription is the one for whom it was written. Once satisfied that those conditions were met, Respondent would fill that prescription and "keep his nose out of it." Respondent never inquired by physicians, whether the drug Methaqualone was medically necessary for treatment. Respondent maintained a detailed patient profile system. That system was used to monitor the dispensing of Schedule II substances. That system insured that Respondent had, at minimum, constructive knowledge of all the dispensing activity at Don's Discount Drugs. Prescriptions of doubtful origin were not filled as were prescriptions where the physical condition of the patient could not be readily determined. Respondent also would not fill a prescription where a doctor's license was in jeopardy. Respondent feels that he took the usual necessary steps to insure that the prescriptions for Methaqualone were properly filled. Don's Discount Drugs received an unusually large number of prescriptions for Methaqualone due to the large number of pharmacists who would not fill the prescriptions and due to the reasonable rate that Respondent charged for each Methaqualone tablet, i.e. $.50 versus the charges of approximately $1.00 to $1.50 per 300 milligram tablet at other pharmacies. Finally, Respondent considered that he was not obligated to second-guess a doctor's medical opinion where Methaqualone was prescribed. Respondent acknowledged that Methaqualone is a dangerous drug and has a high potential for abuse.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is hereby recommended that the license of Respondent Herbert Lazarus, number 5426, be REVOKED. RECOMMENDED this 9th day of May, 1984, at 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 9th day of May, 1984.
Findings Of Fact At all pertinent times, respondent Koa-Shun Wu has been licensed to practice medicine and surgery in Florida. He holds license No. 32315. Dr. Wu trained in Taiwan as a thoracic surgeon. He taught in medical school there and published in his field. When Dr. Wu emigrated to the United States, he hoped to obtain a surgical residency here. Not finding such a position, he took a job at Polk General Hospital in Lakeland as a house physician, then worked as a staff physician in Polk General Hospital's ambulatory care center. In the spring of 1981, Dr. Wu began a general practice near Winter Haven, about 40 miles from Tampa. This lasted some fifteen months. His wife worked with him in the office but it was hard making a go of it financially and, in August of 1982, he closed the practice in order to take his present job at the Florida State Hospital in Chattahoochee. His professional reputation there is good. On April 13, 1982, a 29-year-old woman giving her name as Jennifer Gail Jones presented herself at Dr. Wu's office saying she needed a Pap smear because she was going to join a methadone program in Tampa. She returned on April 28, 1982, complaining of the frequency of her micturition and of discomfort when she urinated. Dr. Wu performed a physical examination and diagnosed a urinary tract infection. On that visit, according to his office records, in addition to dispensing medicine for this infection, Dr. Wu prescribed 50 milligrams of methadone "daily P.R.N,," a total of 30 ten milligram tablets. Joint Exhibit B. Other testimony established that five milligram methadone tablets, but not ten milligram methadone tablets, were available at local pharmacies. Depositions of Fox, Garrett. Perhaps this was communicated to Dr. Wu who wrote a revised prescription. In any event, the prescription that was filled for Jennifer G. Jones on April 28, 1982, was for 60 five milligram methadone tablets and the dosage prescribed was "fifty mg. p. o. daily in A.M." Joint Exhibit R. Dr. Wu wrote this prescription for methadone, his first, after the patient told him she had enrolled in a methadone maintenance program in Tampa on April 12, 1982. (This did not gibe precisely with her statement on her initial visit on April 13 that she was "going to join" at that time.) She said she was receiving 50 milligram doses daily at the Tampa clinic but that some days she could not go to Tampa because she had to work in Winter Haven. Dr. Wu took her at her word and acted to make the same dose available to her on days she did not get to the clinic as she received when she made the trip there. With this straightforward and arguably reasonable step, the die was cast. For this same patient, respondent prescribed an additional 30 five milligram tablets on May 5, 1982, with a prescribed dosage of 20 milligrams every other day and, on May 17, 1982, 40 five milligram tablets at the same dosage. On May 28, 1982, respondent prescribed 24 five milligram tablets to be taken twice daily "on days not going to Tampa clinic." On June 8 and 17, and July 21, 1982, respondent wrote prescriptions for Jennifer Jones, each for 24 five milligram methadone tablets, and each at the dosage of 30 milligrams every other day. (Counts Sixteen, Seventeen and Eighteen) Word spread among other clients of the Tampa methadone program and reached a heroin addict who had not enrolled in a methadone maintenance program, as well. The latter, Mary Joyce Strouse, lied to Dr. Wu on this point. On May 3, 1982, she told him that she had enrolled in the Tampa program a year earlier and that she was receiving 35 milligrams of methadone daily at the clinic. On May 29, June 9 and 25, July 9, 16 and 29 and August 5, 1982, Dr. Wu wrote methadone prescriptions for her. Each was for 24 five milligram tablets and the prescribed dosage was 30 milligrams every other day, except for the first prescription which was 15 milligrams every other day, "P.R.N." or "if not go to Tampa clinic." Joint Exhibit R. Ms. Strouse took the methadone so she "wouldn't have to buy street dope." Deposition of Ms. Strouse, p.10. (Counts Twenty-two, Twenty-three and Twenty-four) Respondent wrote all eleven of the methadone prescriptions for Ralph B. Strouse alleged in Count One. On Mr. Strouse's initial visit, respondent performed a physical examination and took his history, and, on another visit, he removed a bullet lodged in his thigh. He treated various other ailments as well. (Count One, Two and Three) Respondent wrote the seven methadone prescriptions for Voncil Frank Woodrow Snider alleged in Count Four. On the initial visit, he performed a physical examination, and concluded that Mr. Snider was mildly hypertensive and mildly obese. Respondent wrote the four methadone prescriptions for Frankie A. Bailey a/k/a Frankie Smith alleged in Count Seven, the methadone prescription for Angel Reel alleged in Count Ten, the nine methadone prescriptions for Wayne Hoskins alleged in Count Thirteen, the four methadone prescriptions for Henry M. Cain a/k/a Michael Cain alleged in Count Nineteen, the four methadone prescriptions for Deborah Asbel alleged in Count Twenty-five and the latter six of the seven methadone prescriptions for William Asbel alleged in Count Twenty-Eight. Except for Mary Joyce Strouse and Voncil Frank Woodrow Snider, the patients for whom Dr. Wu prescribed methadone participated in a Tampa methadone maintenance program. (Mr. Snider participated in such a program in Orlando.) The Tampa participants were not told what their methadone dosages were. The levels they reported to Dr. Wu were speculation at best. On several occasions Dr. Wu asked for and received receipts from the methadone maintenance clinics indicating current participation, but he did not always do this, and he never telephoned or otherwise contacted either clinic. In all, he wrote some 60 prescriptions for ten people. He charged $20 for an initial office visit and $15 per office visit thereafter. There was no surcharge for methadone prescriptions. (He charged $125 to remove the bullet from Mr. Strouse's thigh.) More than once, Mr. Fox, the pharmacist, telephoned and questioned respondent about the propriety of the methadone prescriptions. At least one patient recalled Dr. Wu's consulting a copy of the Physicians' Desk Reference. Every prescription he wrote after May 20, 1982, (and all but three of the total) was for 24 five milligram tablets. The 1983 Physicians' Desk Reference has this to say about methadone, which is sold under the trade name Dolophine Hydrochloride: CONDITIONS FOR DISTRIBUTION AND USE OF METHADONE PRODUCTS: Code of Federal Regulations. Title 21. Sec. 291.505 METHADONE PRODUCTS. WHEN USED FOR THE TREATMENT OF NARCOTIC ADDICTION IN DETOXIFICATION OR MAINTENANCE PROGRAMS, SHALL BE DISPENSED ONLY BY APPROVED HOSPITAL PHARMACIES, APPROVED COMMUNITY PHARMACIES, AND MAINTENANCE PROGRAMS APPROVED BY THE FOOD AND DRUG ADMINISTRATION AND THE DESIGNATED STATE AUTHORITY. APPROVED MAINTENANCE PROGRAMS SHALL DISPENSE AND USE METHADONE IN ORAL FORM ONLY AND ACCORDING TO THE TREATMENT REQUIREMENTS STIPULATED IN THE FEDERAL METHADONE REGULATIONS (21 CFR 291.505). FAILURE TO ABIDE BY THE REQUIREMENTS IN THESE REGULATIONS MAY RESULT IN CRIMINAL PROSECUTION, SEIZURE OF THE DRUG SUPPLY, REVOCATION OF THE PROGRAM APPROVAL, AND INJUNCTION PRECLUDING OPERATION OF THE PROGRAM. A METHADONE PRODUCT, WHEN USED AS AN ANALGESIC, MAY BE DISPENSED IN ANY LICENSED PHARMACY. Indications: (See Note below.) For relief of severe pain. For detoxification treatment of narcotic addiction. For temporary maintenance treatment of narcotic addiction. NOTE If methadone is administered for treatment of heroin dependence for more than three weeks, the procedure passes from treatment of the acute withdrawal syndrome (detoxification) to maintenance therapy. Maintenance treatment is permitted to be undertaken only by approved methadone programs. This does not preclude the maintenance treatment of an addict who is hospitalized for medical conditions other than addiction and who requires temporary maintenance during the critical period of his stay or whose enrollment has been verified in a program which has approval maintenance treatment with methadone. Contraindication: Hypersensitivity to methadone. Warnings: Methadone hydrochloride, a narcotic, is a Schedule II controlled substance under the Federal Controlled Substances Act. Appropriate security measures should be taken to safeguard stocks of methadone against diversion. DRUG DEPENDENCE--METHADONE CAN PRODUCE DRUG DEPENDENCE OF THE MORPHINE TYPE AND, THEREFORE, HAS THE POTENTIAL FOR BEING ABUSED. PSYCHIC DEPENDENCE, PHYSICAL DEPENDENCE, AND TOLERANCE MAY DEVELOP UPON REPEATED ADMINISTRATION OF METHADONE, AND IT SHOULD BE PRESCRIBED AND ADMINISTERED WITH THE SAME DEGREE OF CAUTION APPROPRIATE TO THE USE OF MORPHINE. Adverse Reactions: THE MAJOR HAZARDS OF METHADONE. AS OF OTHER NARCOTIC ANALGESICS, ARE RESPIRATORY DEPRESSION AND, TO A LESSER DEGREE, CIRCULATORY DEPRESSION. RESPIRATORY ARREST, SHOCK, AND CARDIAC ARREST HAVE OCCURRED. Dosage and Administration: For Relief of Pain--Dosage should be adjusted according to the severity of the pain and the response of the patient. Occasionally it may be necessary to exceed the usual dosage recommended in cases of exceptionally severe pain or in those patients who have become tolerant to the analgesic effect of narcotics. For Detoxification Treatment--THE DRUG SHALL BE ADMINISTERED DAILY UNDER CLOSE SUPERVISION AS FOLLOWS: A detoxification treatment course shall not exceed 21 days and may not be repeated earlier than four weeks after completion of the preceding course. In detoxification, the patient may receive methadone when there are significant symptoms of withdrawal. The dosage schedules indicated below are recommended but could be varied in accordance with clinical judgment. Initially, a single dose of 15 to 20 mg. of methadone will often be sufficient to suppress withdrawal symptoms. Additional methadone may be provided if withdrawal symptoms are not suppressed or if symptoms reappear. When patients are physically dependent on high doses, it may be necessary to exceed these levels. Forty mg./day in single or divided doses will usually constitute an adequate stabilizing dosage level. Stabilization can be continued for two to three days, and then the amount of methadone normally will be gradually decreased. The rate at which methadone is decreased will be determined separately for each patient. The dose of methadone can be decreased on a daily basis of at two-day intervals. But the amount of intake shall always be sufficient to keep withdrawal symptoms at a tolerable level. In hospitalized patients, a daily reduction of 20 percent of the total daily dose may be tolerated and may cause little discomfort. In ambulatory patients, a somewhat slower schedule may be needed. If methadone is administered for more than three weeks, the procedure is considered to have progressed from detoxification or treatment of the acute withdrawal syndrome to maintenance treatment, even though the goal and intent may be eventual total withdrawal. Overdosage: Symptoms--Serious overdosage of methadone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, maximally constricted pupils, skeletal-muscle flaccidity, cold and clammy skin, and, sometimes, bradycardia and hypotension. In severe overdosage, particularly by the intravenous route, apnea, circulatory collapse, cardiac arrest, and death may occur. The foregoing appears under the heading "AMPOULES AND VIALS" to which a reader consulting the "Tablets" Section is referred. In each instance, Dr. Wu undertook maintenance and/or detoxification treatment of narcotic addicts, as opposed to prescribing methadone as an analgesic. Prescriptions for analgesic purposes by an oncologist in the Winter Haven area were for greater quantities (100 tablets) than Dr. Wu prescribed. As a matter of policy, maintenance doses at the Tampa clinic do not exceed 50 milligrams daily but there was testimony that 80 milligrams a day at another clinic in the area was not uncommon and that maintenance doses of 100 or even 120 milligrams, are not unheard of. Dr. Wu referred to Goodman's Textbook of Pharmacology (1980) which states: "Subjects who are maintained on daily oral doses of 100 mg. of methadone for more than 8 weeks still seem sedated and apathetic . . . [but] sedation and apathy are easily managed by reductions in dosage." At 547. Elsewhere the same text states, in reference to methadone maintenance: "Most commonly the procedure consists in the daily administration of 40 to 100 mg. of methadone . . ." At 574. Physicians who treat heroin addiction do not prescribe methadone even when urinalysis reveals the presence of an opiate, unless they observe objective signs (goose bumps, rhinorrhea, elevated blood pressure, body temperature, and pulse rate, etc.) corroborating reported symptoms of withdrawal. They want objective proof of addiction, not just use, before prescribing a maintenance dose of methadone, although they rely on the addict's subjective symptoms to some extent in calibrating the dosage. When the initial dose of methadone is administered, the addict is observed for a half hour, against the possibility of some adverse reaction. After the magnitude of the maintenance dose is determined, it may remain unchanged for months or years. Only when an addict and his counselor agree that there is hope for turning over a new leaf does therapeutic detoxification, the gradual diminution of the methadone dose, occur. Administrative or punitive detoxification, a relatively rapid decrease in dosage, may occur if an addict fails to abide by the rules of the maintenance program by, for example, ingesting or injecting addictive substances other than methadone. Urine samples are regularly taken from persons in methadone maintenance programs and analyzed for evidence of extracurricular drug use. Such analysis can detect the use of heroin but does not ordinarily reveal extra doses of methadone. From the standpoint of an addict who seeks some analgesic or euphoric effect, additional methadone is the ideal way to augment what the clinic prescribes. Partly for this reason, methadone maintenance programs require, at least initially, that their clientele appear personally for each dose, which is administered on the premises. This practice also makes continuity in counseling and urine screening more likely, and minimizes the danger of methadone reaching somebody for whom it was not intended. As time goes on, the program client may be entrusted with one or more "take homes," doses he is to administer to himself off the premises. It is not acceptable practice to give somebody on another maintenance program a dose of methadone without communicating with the people operating the other program. Paragraph 291, Title 21 of the Code of Federal Regulations spells out in detail the legal restrictions that federal law places on methadone maintenance programs. Neither a private medical practitioner nor any other person or organization can lawfully prescribe methadone for a patient for more than three days without being approved as a methadone treatment program by the health authorities. Dr. Wu never sought nor obtained such approval. Methadone is a Schedule II narcotic, a synthetic central nervous system depressant with effects like that of morphine. Dr. Wu testified without contradiction that be believed that the DEA license which he held at all pertinent times authorized him to prescribe all Schedule II narcotics, and that the legal restrictions on dispensing methadone that appeared in the Physicians' Desk Reference did not apply to DEA license holders like himself. These beliefs, were and are erroneous. Goodwin's Textbook of Pharmacology (1980) states: "In the United States, special controls on methadone have been enacted. . . " At 519. When Dr. Wu closed his office, the only notice he gave his patients was posted on the door at the office at the time he left.
Recommendation Upon consideration of the foregoing, it is RECOMMENDED: That petitioner suspend respondent's license for three months, but stay the suspension, on condition that respondent successfully complete two years' probation during which probation he be forbidden to prescribe controlled substances and be required to take at least fifty (50) hours of continuing professional education pertaining to controlled substances. DONE and ENTERED this 19th day of January, 1984, in Tallahassee, Florida. ROBERT T. BENTON II 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 19th day of January, 1984. COPIES FURNISHED: Joseph W. Lawrence, II, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Melissa Fletcher Allaman, Esquire and Wilfred C. Varn, Esquire Ervin, Varn, Jacobs, Odom & Kitchen Post Office Box 1170 Tallahassee, Florida 32302-1170 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Dorothy Faircloth, Executive Director Board of Medical Examiners Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 =================================================================
Findings Of Fact Respondent, Ben Cohn (Cohn), was at all times material hereto a licensed pharmacist in the State or Florida, having been issued license number 0009536. At all relevant times, Cohn was employed as a pharmacist at Don's Discount Drugs in South Miami, Florida. 1/ In or about October, 1981, Don's Discount Drugs was targeted by the Department of Professional Regulation and the Drug Enforcement Administration for a drug diversion audit of all Schedule II prescription drugs. The impetus for the audit was the quantity of methaqualone tablets, a Schedule II prescription drug, that were being dispensed at the store. The audit revealed no improprieties in the control or accountability of Schedule II prescription drugs at Don's Discount Drugs, but did reveal that during the period from August 4, 1981, through January 6, 1982, Don's Discount Drugs had dispensed 202,404 methaqualone 300 mg. tablets on 4,695 prescriptions. 2/ Of theses Cohn dispensed 118,130 methaqualone tablets on 2,724 prescriptions. The vast majority of these prescriptions were written for 45 tablets. The physicians who wrote the prescriptions which Cohn filled were largely employed by "stress clinics". These clinics actively advertised and solicited patients suffering from stress, and frequently prescribed methaqualone. There is, however, no competent proof that these clinics operated illegally, or that the physicians who wrote the prescriptions at issue in this case failed to do so in the good faith practice of their profession. During the time in question, it was legal in the State of Florida to prescribe and to dispense methaqualone. However, of the approximately 400 community pharmacies in Dade County only 10 would fill methaqualone prescriptions. Cohn knew he was dispensing a controversial drug with a high potential for abuse. Consequently, in filling each of the methaqualone prescriptions in question, as with all Schedule II drug prescriptions, Cohn followed a rigid procedure. As to each prescription, he verified that the person presenting the prescription was the person to whom the prescription was written by requiring a driver's license or others photo identification. Cohn then contacted the United States Department of Justice Drug Enforcement Administration to verify that the prescriber had a current DEA number. Cohn then verified with the prescriber that the prescription had been written for that patient and verified the number of tablets reflected on the prescription. Lastly, Cohn placed that patient's name and address on an index card together with the name of the doctor and the date of the prescription. These cards were maintained in a special file for reference in filling prescriptions to prevent dispensing any Schedule II drugs to the same person as a result of multiple prescriptions issued in too short a time period. All of the prescriptions in question were written by prescribers who were duly licensed by the Florida Board of Medical Examiners. None of the prescriptions in question was written or filled for an excessive number of methaqualone written tablets. 3/ Further, the parties have stipulated that Cohn complied with each of the conditions prescribed by Subsections (a)-(g), Section 893.04(1), Florida Statutes. Notwithstanding the fact that Petitioner offered no proof that any prescription filled by Cohn was not issued by a physician in the good faith practice of his profession, or was otherwise counterindicated, it suggests that Cohn did not act in good faith and in the course of professional practice when he filled the prescriptions. Factors which Petitioner deems important to such conclusion are: (1) the large number of prescriptions issued for the same quantity of drug, (2) the limited number of prescribers, (3) that most prescribers worked at "stress clinics", (4) the sudden influx of patients 18-30 years of age to fill prescriptions, (5) the precounting and prepackaging of methaqualone at the store, (6) the "general tone" of the community in regard to the abuse factor of methaqualone, (7) Cohn's failure to ascertain whether the drug was "for the benefit and welfare" of the patient, and (8) that many of the prescribing physicians maintained their offices outside the general neighborhood of the store. Petitioner's proof was not, however compelling. While the dispensing of 202,404 methaqualone tablets at Don's Discount Drugs between August 4, 1981, and January 6, 1982, appears facially to be a large quantity, Petitioner offered no proof to demonstrate its significance. No evidence was presented comparing the total number of methaqualone prescriptions filled at Don's Discount Drugs to the total number of methaqualone prescriptions filled in Dade County at the time. No evidence was presented comparing the number of methaqualone prescriptions filled at Don's Discount Drugs to the total number of prescriptions filled at that pharmacy. No evidence was presented concerning the statistical significance, if any, of the quantities of methaqualone tablets dispensed at Don's Discount Drugs. In sum, the dispensing of 202,404 methaqualone tablets at Don's Discount Drugs between August 4, 1981, and January 6, 1982, which represents an average of 35 prescriptions filled each day, was not demonstrated to be disproportionate to the legitimate needs of the population of Dade County. While many of the prescribers did maintain their offices outside the pharmacy's neighborhood, and a large number of methaqualone tablets dispensed at Don's Discount Drugs, it is significant that only 10 of 400 community pharmacies in Dade County would fill such prescriptions. Under such circumstances, it would not be unusual for such physicians' patients to travel to fill their prescriptions. Neither would it be unusual to find a large number of prescriptions being filled at the limited number of pharmacies willing to fill them. While Cohn did not ascertain whether the prescriptions were written "for the benefit and welfare" of the patient, or otherwise seek to second guess the attending physician by inquiring about the circumstances or diagnosis that prompted the prescription, he did confirm that the physician was properly licensed and that the physician had issued the prescription to the patient who presented it. The Department offered no credible proof that any physician misappropriately prescribed any drugs in this case. Accordingly, the presumption is that the physicians who wrote the subject prescriptions acted lawfully, and in the good faith practice of their profession. See: Atlantic Coast Line R. Co. v. Mack, 57 So.2d 447 (Fla. 1952). Under such circumstances, it cannot be concluded that Cohn failed to act in good faith and in the course of professional practice when he filled such prescriptions. The remaining factors cited by Petitioner are equally unpersuasive. The fact that the prescriptions were written by a limited number of physicians, most of whom were employed by "stress clinics", was not compelling because there was no showing that such physicians operated improperly. The fact that the store experienced a sudden influx of patients 18-30 years of age was not shown to be pertinent since there was no proof that the prescribing of methaqualone to such age group was counterindicated 4/ The fact that Don's Discount Drugs precounted and prepackaged methaqualone tablets demonstrated only that they anticipated a demand for the product; not any impropriety. Cohn's knowledge of the abuse potential for methaqualone and the procedures he employed to avert such abuse, was addressed in paragraph 6, supra. In rejecting petitioner's contention that Cohn failed to act in good faith and in the course of professional practice, I do not suggest that the factors advanced by Petitioner are not necessarily pertinent to the inquiry. Rather, I conclude that in this case such proof was not persuasive because there was no competent proof that any physician misprescribed or acted other than in the good faith practice of his profession. Such being the proof, it cannot be concluded that Cohn violated a community standard by filling a lawful and proper prescription. Cohn was first licensed as a practicing pharmacist in the State of New York in 1945, and has been practicing in the State of Florida since 1961. He has never been disciplined and has never had an administrative complaint, other than the instant complaint, filed against him regarding his practice of pharmacy.
Recommendation Based on the foregoing Finding of Fact and Conclusions of Law, it is RECOMMENDED: That a Final Order be entered DISMISSING the Administrative Complaint. DONE AND ORDERED this 9th day of September, 1987, in Tallahassee, Florida. WILLIAM J. KENDRICK Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 9th day of September, 1987.
