vs. ) CASE NO. 81-1951
Respondent. )
Pursuant to notice, the Division of Administrative Hearings, by its duly designated Hearing Officer, SHARYN L. SMITH, held a formal hearing in the above- styled case on February 26, 1982, in Coral Gables, Florida. The following appearances were entered:
For Petitioner: Michael J. Cohen
For Respondent: Vincent J. Flynn, Esquire
The issue for determination at the final hearing was whether the Respondent's license to practice pharmacy should be revoked, suspended or other disciplinary action imposed for allegedly improperly handling classified drugs and failing to follow the record keeping requirements connected with such drugs. At the hearing, Brooks Harle, Vernon Bell, Ellis L. Kahn, Lorraine Gronfine, Jesse Jacob, Irving Losee and Daniel R. Tullen testified on behalf of the Petitioner. Petitioner's Exhibits 1-24 were offered and admitted without objection. Additionally, post-filed exhibits have been received by the Hearing Officer and admitted as Petitioner's Exhibits 25, 26, 27 and Respondent's Exhibit 1. The Respondent Herman Ginsberg testified on his own behalf. 1/
Proposed Recommended Orders have been submitted by the parties, To the extent that the proposed findings submitted by the parties are not reflected in this Order, they are rejected as unsupported by the weight of credible evidence or as being immaterial to the results reached.
The Respondent Herman Ginsberg is a licensed pharmacist having been issued license number 0008019. The last known address of the Respondent is 775 Northeast 164th Street, North Miami Beach, Florida 33162.
At all times material to this proceeding, the Respondent was the managing pharmacist at Jaffe Pharmacy, also known as Jaffe Discount Drugs, located at 737 Northeast 167th Street, North Miami Beach, Florida 33162.
On or about November 26, 1980, the Respondent Ginsberg directed a clerk at the pharmacy, Lorraine Gronfine to remove nine (9) prescriptions from the class II prescription records and place them under a desk blotter.
The scripts were pulled by Ms. Gronfine prior to a drug inspection by the authorities. According to the Respondent Ginsberg, he was ordered by the manager of the pharmacy, Ed Terry, to pull the prescriptions in order to inflate an insurance claim resulting from a burglary which occurred in September 1980. The Respondent complied with Mr. Terry's request and reported that drugs were stolen which were not in fact stolen in order to inflate an insurance claim to approximately $7,000.
The prescriptions were discovered under the blotter by Irving Losee, another pharmacist employed by Jaffe, who turned them over to Graymark Security. Graymark personnel questioned both the Respondent and Ms. Gronfine about the prescriptions and both gave statements to Graymark concerning how the prescriptions came to be placed under the blotter.
Many, although not all, of the prescriptions found by Losee were altered. No testimony expert or otherwise was introduced to prove that the Respondent altered the prescriptions in question. As noted by counsel for Respondent, no direct evidence was introduced to rebut the Respondent's sworn denial that he personally altered the prescriptions.
In the normal course of business at Jaffee Pharmacy, a patient log was kept for all prescriptions filled on a daily basis. It is undisputed by the parties that the patient log, which was kept by the Respondent, was not altered and reflected the actual number of pills dispensed by the pharmacy. In order to divert classified drugs for personal profit, it is logical to assume that the Respondent would have altered the patient logs along with the prescriptions to consistently cover the amount of classified drugs ordered from pharmaceutical companies and placed on record with the Drug Enforcement Administration.
Indeed, the failure to alter the daily patient logs to be consistent with the altered prescriptions was one of the ways that the problem with the altered prescriptions was uncovered.
Although Mr. Terry examined the patient logs nightly to grade his employees on their sales of drugs, this would not have necessarily stopped the logs from being changed to conform to the altered prescriptions. The Respondent or anyone with access to the patient logs, could have altered the logs after the nightly review and conform the logs and prescriptions without arousing undue suspicion. No testimony was presented concerning this point other than that the logs did not go to accounting and were presented to Mr. Terry for his review.
If Mr. Terry kept the logs and the Respondent had no further access to them, the Petitioner's theory concerning the alterations would be more plausible; however, the record failed to show that the Respondent lacked the ability to alter the logs subsequent to Mr. Terry's review.
Each prescription placed into evidence and filled by the Respondent is marked as being "verified by the issuing physician." The Respondent has admitted that some of these prescriptions were not verified and that the certifications were erroneous.
The Respondent admitted that a person named Fred Sessler, who was associated with a stress or obesity clinic, was permitted to pick up controlled drugs for the clinic without a prescription. Mr. Sessler was apparently permitted this privilege because the Respondent knew that one of the clinic physicians would eventually furnish a prescription.
Additionally, the Respondent has admitted that in connection with the Sessler transactions, he failed to immediately record all the information required in order to dispense oral prescriptions and failed to notify the Drug Enforcement Administration that he was emergency dispensing via telephone.
While acting as managing pharmacist at Jaffee, the Respondent ordered and distributed excessive quantities of a Schedule II drug. (See Petitioner's Exhibit 26 and Respondent's Exhibit 1.)
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the parties and subject matter of this dispute. See Section 120.57(1), Florida Statutes.
The Respondent Ginsberg has been charged in a twenty- two count Administrative Complaint with violating numerous provisions of the Florida Statutes and Florida Administrative Code. In order to simplify this case, the counts will be grouped and discussed by category.
Count I - Concealment of Pharmaceutical Records
Count I alleges that on or about November 26, 1980, the Respondent directed Lorraine Gronfine to remove nine (9) prescriptions from the Class II prescription records and hide them under a desk blotter. This action occurred prior to a pharmacy inspection and six of the nine prescriptions had been altered to increase the quantity of medication.
The Respondent admitted pulling the prescriptions and directing Ms. Gronfine to set the prescriptions aside, but denied that he altered the prescriptions or hid them in order to conceal the altered prescriptions prior to a drug inspection. The Respondent asserted that he pulled the prescriptions on orders from Mr. Terry, the store manager, to inflate an insurance claim resulting from a burglary which occurred in September 1980.
The Respondent has been charged in Count I with violating Sections 465.016(1)(j) and 465.016(1)(e), Florida Statutes, which empower the Board of Pharmacy to take disciplinary action against a licensee:
(j) [m]aking or filing a report or re- cord which the licensee knows to be false, intentionally or negligently failing to
file a report or record required by federal or state law, willfully impeding or ob- structing such filing or inducing another person to do so. Such reports or records shall include only those which the licensee is required to make or file in his capacity as a licensed pharmacist.
* * *
(e) [v]iolating any of the requirements
of this chapter; chapter 500, known as the "Florida Food, Drug, and Cosmetic Law";
21 USC, ss.301-392, known as the "Federal Food, Drug and Cosmetic Act"; or chapter 893.
Additionally, the Respondent is charged with violating Section 465.016(1)(e), through operation of Sections 893.13(3)(a)(3) and/or 893.l3(2)(a)(2), Florida Statutes, which make it unlawful for any person to:
...refuse or fail to make, keep or furnish any record, notification, order form, state- ment, invoice, or information required under this chapter. [See Section 893.13(2)(a)(2)]
and/or ... furnish false or fraudulent material information in, or omit any material infor- mation from, any report or other document re- quired to be kept or filed under this chapter... [See Section 893.13(3)(a)(3)]
The Petitioner has failed to carry its burden or proof as to this count. All of the statutes which the Respondent is charged with violating deal with the false filing of reports, either intentionally or negligently, rather than the obstructive acts alleged to have been committed by the Respondent. The Respondent is not charged with failing to file reports or filing false reports, but of directing Ms. Gronfine to conceal altered and unaltered prescriptions. The acts which the Respondent committed simply do not fall within the activities proscribed by the statutes cited in Count I.
Counts II-VII - Altering Legitimate Prescriptions to Increase the Quantity or Size or Medication Prescribed
In each of these counts the Respondent is charged with increasing the quantity or size of controlled drugs on prescriptions filled at Jaffe Pharmacy. There is no dispute that the prescriptions referenced in these counts were dispensed by Jaffe and were altered as alleged in the Administrative Complaint.
The Petitioner contends that the Respondent altered the prescriptions in order to increase the amount of drugs dispensed and kept the difference for illegal profit. The Respondent does not dispute that the prescriptions were altered, but denies that he altered the prescriptions or profited from the illegal sale of controlled drugs. 2/
In each of these counts, the Respondent by his alleged actions is charged with violating Sections 465.016(1)(j), 465.016(1)(e) and 893.13(3)(a)(3), Florida Statutes, as set forth, supra, in the discussion of Count I.
The Petitioner has candidly characterized the evidence presented on these counts as "circumstantial, but sweeping." No direct evidence was presented to link the Respondent to the alteration of the prescriptions in question. The Respondent was not the only person working at Jaffe who could have altered the prescriptions in this case; indeed, the pharmacy had more than its share of individuals associated with it who could charitably be described as less than model citizens. The fact that the Respondent engaged in unsavory and perhaps unethical business practices does not lessen the state's burden of proof
in cases in which a professional license is at stake. Indeed, in proceedings of this type where a regulatory agency seeks to discipline a person in a manner substantially affecting the practice of his profession, the state must prove the allegations of the Administrative Complaint by clear and convincing evidence which must be as substantial as its consequences. Bowling v. Department of Insurance, 394 So.2d 165, 172 (Fla. 1st DCA 1981); Gans v. Department of Professional and Occupational Regulation, 390 So.2d 107 (Fla. 3d DCA 1980); Walker v. Board of Optometry, 322 So.2d 612 (Fla. 3d DCA 1975); Reid v. Florida Real Estate Commission, 188 So.2d 846, 851 (Fla. 2d DCA 1966).
The threads of circumstantial evidence woven throughout these counts do not rise to the level of "clear or convincing evidence" required by law to be demonstrated by the Petitioner. That many of the Respondent's activities while employed at Jaffe were predatory and reprehensible were unrebutted. The Respondent is not, however, charged with being offensive, but with altering specific prescriptions, a charge which was not sufficiently proven at hearing. See Bowling, supra, at 175, "... in our heritage the accused's unbelievable denial of an essential element in the allegation does not prove the accusation."
Counts IX-XV False Verifications
In these counts, the Petitioner has charged the Respondent with violating Sections 465.016(1)(j), 465.016 (1)(e) and 893.13(3)(a)(3), Florida Statutes, as set forth, supra, in the discussion of Count I, by writing "verified or verified M.D." on all prescriptions filled, whether they were actually verified or not.
Each prescription in Counts IX-XV placed in evidence is marked verified, while statements from the issuing physicians were introduced showing that the pharmacy in fact failed to verify the same. The Respondent admitted that some of the prescriptions in question were not verified. This should be expected since it was the policy at Jaffe to write verified on all prescriptions regardless of what actually occurred.
As to these counts, the Petitioner carried its burden of proof that the Respondent filled the prescriptions set forth in Counts IX-XV without actually verifying the prescriptions with the prescribing physician and as such, made a false record of the prescription which he is required by law to keep in his capacity as a licensed pharmacist, in violation of Sections 465.0l6(1)(j) and (e) and 893.13(3)(a)(3), Florida Statutes.
Count VIII - Sale of Controlled Drugs Without A Prescription
The Respondent is charged in this count with violating Section 465.016(1)(i), Florida Statutes by selling drugs or allowing them to leave the store in the absence of a valid prescription. Section 465.016(1)(i), Florida Statutes prohibits:
[c]ompounding, dispensing or dis- tributing a legend drug, including any con- trolled substance, or otherwise in the course of professional practice of pharmacy ...
A pharmacist may only dispense drugs pursuant to a bona fide prescription for a legitimate purpose. A prescription for a controlled substance listed in Schedule II may be dispensed only upon a written
prescription of a practitioner, except in an emergency situation, as defined by regulation of the Department of Health and Rehabilitative Services, such controlled substance may be dispensed upon oral prescription. See Section 893.04(1)(f), Florida Statutes.
The Petitioner established that Fred Sessler, the owner of a stress or obesity clinic, came to Jaffe's to pick up classified drugs for delivery to patients who were unable to come to the pharmacy. Although clinic physicians subsequently furnished written prescriptions to the Respondent for the controlled drugs given to Mr. Sessler, no testimony was presented that the clinic physicians or other authorized persons had orally prescribed the drugs based on emergency situations.
Counts XVI and XVII - Dispensing Schedule II Upon Alleged Oral Prescriptions
In these counts, the Respondent is charged with delivering drugs to Mr. Sessler without reducing the prescriptions to writing and dispensing on a non-emergency basis. Additionally, it is alleged that the Respondent failed to ensure that when the oral prescriptions were reduced to writing, they contained the statement "authorization for emergency dispensing" and failed to report this fact to the Drug Enforcement Administration.
Section 893.O4(1)(f), Florida Statutes and 21 CFR Section 1306.11, define the procedure for dispensing a controlled substance upon an oral prescription on an emergency basis. Two of the requirements imposed by 21 CFR Section 1306.11 were admittedly violated by the Respondent; the failure to require that written prescriptions, which must be furnished within 72 hours, bear on their face all information required by law including "authorization for emergency dispensing" and the proper notification being provided to appropriate federal authorities when the prescriptions were not filed as required which resulted in the Respondent's authority to dispense being voided by operation of law.
The Petitioner has sustained its burden of proof as to these counts.
Counts XVIII-XX - Partial Filling and Overfilling
Drug Prescriptions
These counts charge the Respondent with violating Section 465.016(1)(e), Florida Statutes, and 21 CFR Section 1306.13 which prohibits partial filling of prescriptions subsequent to 72 hours of the first partial filling.
The Respondent admitted partially filling Jesse Jacobs prescriptions for Nebutal without complying with the requirements of 21 CFR Section 1306.13(a), which state:
[t]he partial filling of a prescription for a controlled substance listed in
Schedule II is permissible, if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescrip- tion and he makes a notation of the quantity supplied on the face of the written prescrip- tion (or written record of the emergency oral prescription). The remaining portion of
the prescription may be filled within 72 hours of the first partial filling; however, if the remaining portion is not or cannot be filled within the 72-hour period, the pharmacist shall so notify the prescribing individual practitioner. No further quantity may be sup-
plied beyond 72 hours without a new prescription.
Jesse Jacobs testified that the prescriptions in these counts were partially filled by the Respondent as a personal favor to Mr. Jacobs so that he would not be tempted to take more pills than were required for his condition.
As to these counts, the Petitioner has met its burden that the Respondent violated the above-referenced laws in partially filling the Jacobs' prescriptions.
Counts XXI - Falsified Theft Report
The Respondent is charged in this count with reporting the loss of controlled substances as the result of a burglary which took place in September of 1980 at Jaffe Pharmacy in an amount materially in excess from the amount of loss the Respondent knew was actually stolen. Based on these alleged facts, the Respondent is accused of violating Sections 465.016(1)(j), 465.016(1)(e), 893.13(3)(a)(3) and 893.13(2)(a)(2), Florida Statutes, as set forth in the discussion of Count I, supra.
Although the Proposed Recommended Order filed by Petitioner accuses the Respondent of falsifying the loss of controlled and uncontrolled substances, the Administrative Complaint specifically limits the allegation against the Respondent to theft of controlled substances.
The Petitioner has demonstrated that the Respondent participated in a scheme to defraud an insurance company by falsely inflating the amount of merchandise stolen following a burglary. The Respondent does not deny that he participated in this scheme, but does deny that he falsified records concerning the theft of controlled substances. If the Administrative Complaint charged that the Respondent simply filed a false report of a burglary and such conduct was prohibited by the statutes set forth, supra, the Petitioner would prevail on this count. However, because the Complaint charges the Respondent with falsifying the records of controlled substances, the Petitioner has not met its burden as to Count XXI. 3/
Count XXII - Dispensing Drugs in Excessive Quantities
In the final count of the Administrative Complaint, the Respondent is charged with ordering and/or causing to be dispensed excessive or inappropriate quantities of controlled substances during 1979 and 1980, in violation of Section 465.016(1)(i), Florida Statutes, which prohibits:
[c]ompounding, dispensing, or distri- buting a legend drug, including any con- trolled substance, other than in the course of professional practice of pharmacy. For purposes of this paragraph, it shall be legally presumed that the compounding, dis- pensing or distributing of legend drugs in
excessive or inappropriate quantities is not
in the best interests of the patient and is not in the course of the professional practice of pharmacy.
As stated by counsel for Petitioner, the amount of controlled drugs ordered and dispensed by the Respondent or under his supervision was "astounding". While under the Respondent's supervision, this pharmacy dispensed controlled drugs based on one overriding consideration, the maximization of profits. According to Drug Enforcement Administration records furnished to the parties as late filed exhibits, the amount of methaqualone products purchased by the pharmacy and reported to the agency for the period January 1980 through July 1980, total 25,700. 4/ The Respondent, who ordered for the pharmacy did not dispute that Jaffes did a high volume in controlled substances, indeed, he stated candidly that the owners were primarily concerned with running short of these drugs and as a result, losing sales.
Counsel for the Respondent has asserted that since the pharmacy was presented with prescriptions from licensed physicians for the controlled substances dispensed, the Respondent should not be required to "second guess" physicians. Under ordinary circumstances, the undersigned would concur completely with counsel; however, the situation which existed at Jaffes was hardly ordinary.
In enacting Section 465.016(1)(i), Florida Statutes, the legislature attempted to place a duty on a licensed pharmacist to ensure that a prescription for a controlled substance is issued for a legitimate medical purpose. The pharmacist is required to exercise his own professional judgment with respect to the legitimacy of prescription orders for controlled substances he dispenses, United States v. Kershman, 555 F.2d 198 (5th Cir. 1977), notwithstanding the existence of a prescription from a licensed physician. The Respondent candidly summarized the procedures he followed at Jaffes in ordering and dispensing controlled drugs as follows:
We did do an awful lot. We did. We filled an awful lot of prescriptions. Those records from the orders that you have there are close. The owners did not want me at anytime to run short of mer- chandise. If the prescriptions were legi- timate, they had validity, you fill them. There's no reason why not to fill legiti- mate prescriptions. That was their code. But don't run out of merchandise and buy them right. They wanted us to spend as much as I wanted. I had never worked in a place like that. They gave me lee-way
and so I treated a narcotic, outside of the record taking, no different than any other prescription . I ordered in advance and
I would try to see that I got the best buy and to see that I was amply stocked. Its as simple as that. (Emphasis supplied) (Transcript pp. 208-209)
In following such procedures and dispensing controlled drugs in the quantities established in this proceeding, the Respondent acted outside the course of the professional practice of pharmacy and, as such, violated Section
465.016 (1)(i), Florida Statutes.
Summation of Charges and Consideration of Appropriate Penalty
In sum, the Petitioner Department of Professional Regulation, Board of Pharmacy has sustained its burden of proof as to Counts VIII, IX-XX, and XXII and failed to carry its burden of proof as to Counts I-VII and XXI, and these counts should be dismissed.
In determining the appropriate penalty in this case, counsel for Respondent has urged that the penalty imposed should correspond to the gravity of the offenses which he has characterized as technical in nature. The statutes which the Respondent violated concerning record keeping requirements and partially filling prescriptions for Mr. Jacobs are the least serious and could be characterized as technical violations which would not warrant suspension or revocation of a professional license. However, the final count of the Administrative Complaint can hardly be characterized as a technical violation and relates directly to the ability of the Respondent to practice pharmacy without causing harm to customers specifically and the public generally. The Respondent's actions while at Jaffe constituted a threat to the public health and safety; a charge that goes to the core of the state's interest in regulating professionals such as pharmacists.
In this case, no testimony or documentary evidence was introduced to prove that the Respondent had been the subject of previous disciplinary proceedings. Therefore, it is assumed that this case marks the first instance in which the Respondent was found to have violated any provision of Chapter 465, Florida Statutes.
The power to revoke a license to practice a profession should be exercised cautiously and should be directed only toward those who by their conduct have forfeited their right based upon substantial causes justifying the forfeiture. Reid v. Florida Real Estate Commission, 188 So.2d 846 (Fla. 2d DCA 1966); Pearl v. Florida Real Estate Commission, (Fla. 3d DCA 1981). The Respondent's lack of concern for the policies established at Jaffes indicate that he lacks the requisite ethical and professional ability to presently practice as a pharmacist. If it had been established by clear and convincing evidence that the Respondent diverted controlled substances for illegal profit or somehow shared in the sale of controlled drugs while employed at Jaffes, permanent revocation would unquestionably be appropriate in this case. However, insufficient evidence was presented to demonstrate such a level of involvement by the Respondent.
Pursuant to Section 465.016(2), Florida Statutes, the Board of Pharmacy is empowered to revoke, suspend, fine, reprimand and/or place on probation any pharmacist found to have violated Section 465.016(1), Florida Statutes.
That the license of the Respondent Herman Ginsberg be suspended for two (2) years and that he be placed on probation for three (3) years thereafter, subject to attending appropriate continuing education classes and working under the direct supervision of a pharmacist approved by the Board.
DONE and ENTERED this 27th day of January, 1983, in Tallahassee, Florida.
SHARYN L. SMITH
Filed with the Clerk of the Division of Administrative Hearings this 27th day of January, 1983.
1/ At the close of the hearing, the record was left open in order to permit the parties to file post-hearing exhibits in the possession of the Drug Enforcement Administration. Following the filing of this information, an order was entered requiring the parties to file Proposed Recommended Orders by October 15, 1982.
2/ It is presumed that the records which the Respondent is charged with altering in these counts are the prescriptions themselves rather than reports dealing with the alleged thefts that were furnished to the public safety department, the Drug Enforcement Administration and the insurance carrier.
3/ The dispute between the Respondent and Mr. Losee concerning the quantities of drugs kept in the front of the store has been resolved in favor of the Respondent. Given the amount of controlled drugs ordered and dispensed by Jaffe, it is logical to assume that large quantities of controlled drugs were kept where they would be accessible to any pharmacist dispensing drugs at Jaffes. The allegation concerning Ms. Gronfine and the stolen Darvon bottle has not been sustained due to the absence of a reasonably reliable identification that the Darvon bottle was in fact the one listed as stolen following the September burglary.
4/ Counsel for the Petitioner has furnished the Hearing Officer a post-filed exhibit (Petitioner's Exhibit 27) which reflects that between January 1980 and July 1980, 29,100 methaqualone, 300 mg. were purchased by Jaffe and 26,813 were dispensed.
Michael J. Cohen, Esquire Suite 101 Kristin Building 2715 East Oakland Park Blvd.
Vincent J. Flynn, Esquire 1414 Coral Way
================================================================= AGENCY FINAL ORDER
DPR NO. 0010901
vs. DOAH NO. 81-1951
License No. 8019
Respondent.
THIS CAUSE came on to be heard before the Florida Board of Pharmacy of the Department of Professional Regulation at a regularly scheduled meeting held on March 18, 1983, in Tallahassee, Florida. After reviewing the exceptions which have been filed with respect to the Recommended Order entered in this case by Sharyn L. Smith, Hearing Officer, Division of Administrative Hearings, on January 27, 1983, and after reviewing the complete record accompanying the Recommended Order, and being otherwise fully advised in the premises, the Florida Board of Pharmacy (Board) hereby adopts the Findings of Fact contained in the Recommended Order. The Board adopts the Conclusions of Law contained on pages five (5) through sixteen (16) of the Recommended Order with one exception. On page seven (7) of the Recommended Order the last paragraph dealing with Count I is deleted. In its place is substituted the following:
Concealment from drug inspectors is a vio- lation. Section 893.13(2)(a)(2), Florida Statutes, requires Respondent to keep or furnish any record, notification,
order form, statement, invoice or information required under this Chapter. By concealing prescriptions of Class II drugs from any inspector, the Respondent violated this statute. whether the concealment was for the purpose of committing a fraud against the insurance company or preventing discovery by the
Drug Enforcement Administration or the Department of Professional Regulation, makes no difference. A factual basis was shown to support a finding that the applicable statutes were violated because the applica- ble records were not properly kept and maintained.
The Board hereby accepts the Recommended Penalty contained in the Recommended Order.
DONE AND ORDERED this 30th day of March, 1983, by the Florida Board of Pharmacy.
H. F. Bevis, Executive Director Florida Board of Pharmacy
Vincent J. Flynn, Esquire
