.
vs. ) CASE NO. 82-1018
Respondent. )
Pursuant to notice, the Division of Administrative Hearings, by its duly designated Hearing Officer, James E. Bradwell, held a public hearing in this case on November 3, 1982, in Miami, Florida. The parties were afforded leave through January 18, 1983, to submit proposed memoranda supportive of their respective positions. Additionally, the parties waived the thirty-day time requirement that a recommended order be entered herein within thirty days following the close of the hearing. Petitioner's counsel has submitted a proposed recommended order which was considered by me in preparation of this Recommended Order. 1/
For Petitioner: W. Douglas Moody, Jr., Esquire
The issue presented for decision herein is whether or not the Respondent dispensed or was manager of a pharmacy department from which was dispensed the controlled substance Methaqualone in such a manner as to constitute the unprofessional practice of pharmacy within the meaning of sections 465.016(1)(e) and (i); 893.04(1) and 893-04(1)(c)6, Florida Statutes.
At the outset of the hearing, Respondent acknowledged and adopted all factual paragraphs of a request for admission filed by Petitioner, a copy of which was filed with this Division on September 19, 1982. These facts being admitted are herein incorporated where applicable. During the course of presenting its case in chief, Petitioner presented three individuals received as experts regarding the professional practice of pharmacy.
Based upon my observation of the witnesses and their demeanor while testifying, documentary evidence received including post-hearing memoranda, I hereby made the following relevant:
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.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the subject matter and the parties to this action. Chapter 120.57(1), Florida Statutes.
The parties were duly noticed pursuant to the notice provisions of Chapter 120, Florida Statutes.
The Department of Professional Regulation, Board of Pharmacy, derives its authority from Section 465, Florida Statutes (1981).
Respondent, a licensed pharmacist, is subject to the disciplinary guides of Section 465, Florida Statutes. During times material herein, Respondent served as the managing pharmacist for Don's Discount Drugs.
Section 465.018, Florida Statutes (1981) places the responsibility for the conduct and practice of a particular pharmacy on that individual designated as the managing pharmacist. Further, a pharmacist is required to determine from the relevant facts and circumstances surrounding each prescription he honors whether or not it is written for a legitimate medical purpose.
Section 465.018(1), Florida Statutes, provides: compounding, dispensing or distributing a legend drug, including any controlled substance, other than in the course of professional practice of pharmacy, amounts to an act which shall be grounds for disciplinary action. Section 465.016(1)(i), Florida Statutes. For compounding, dispensing or distributing of legend drugs in excessive or inappropriate quantities is not the best interests of the patient and is not in the curse of the professional practice of pharmacy.
The actions of the Respondent while acting as managing pharmacist for Don's Discount Drugs and permitting the dispensing, without inquiry, of 133,667 Methaqualone 300 milligram tablets from October 23, 1981 through January 6, 1982 amounts to the dispensing and distributing of a controlled substance other than in the course of professional practice of pharmacy and other than in good faith in violation of Sections 465.016(i) and 893.04(1), Florida Statutes (1981). Respondent's dispensation of the above amounts of Methaqualone appear to fall within the guides of "excessive" and/or "inappropriate" quantities and fits the legal presumption of distribution of a controlled substance not in the best interests of patients and not in the course of the professional practice of pharmacy. Section 465.016(1), Florida Statutes (1981).
Based thereon, Respondent, during that time period individually by dispensing 59,717 units, without inquiry, of 300 milligram Methaqualone tablets, engaged in conduct considered herein to be the dispensation or distribution of a controlled substance other than in the course of the professional practice of pharmacy and other than in good faith in violation of Sections 465.016(i) and 893.04(1), Florida Statutes (1981).
Respondent, by virtue of the foregoing violations of Chapters 465 and 893 is derivatively guilty of violating Section 465.016(e), Florida Statutes (1981).
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
Filed with the Clerk of the Division of Administrative Hearings this 9th day of May, 1984.
1/ To the extent that the proposed findings, etc. are not incorporated in this Recommended Order, said proposed findings, etc. were deemed either irrelevant, immaterial or not otherwise supported by record evidence.
2/ Based on the evidence adduced herein, it is found that Respondent served as managing pharmacist throughout his tenure of employment at Don's Discount Drugs.
W. Douglas Moody, Jr., Esquire
119 N. Monroe Street Tallahassee, Florida 32302
130 N. Monroe Street Tallahassee, Florida 32301
