STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
DEPARTMENT OF PROFESSIONAL ) REGULATION, BOARD OF PHARMACY, )
)
Petitioner, )
)
vs. ) CASE NO. 81-1917
)
BEK-NEW CHEMIST and HOWARD )
NEWMAN as Owner/Operator, )
)
Respondent. )
) DEPARTMENT OF PROFESSIONAL ) REGULATION, BOARD OF PHARMACY, )
)
Petitioner, )
)
vs. ) CASE NO. 81-1918
)
HOWARD NEWMAN, )
)
Respondent. )
)
RECOMMENDED ORDER OF DEFAULT
Pursuant to notice, this cause came on for formal hearing before P. Michael Ruff, duly designated Hearing Officer of the Division of Administrative Hearings, on May 25, 1983, in Miami, Florida.
APPEARANCES
For Petitioner: Bruce D. Lamb, Esquire
130 North Monroe Street Tallahassee, Florida 32301
For Respondent: No Appearance
Pursuant to an Administrative Complaint filed by the above-styled Petitioner, the Respondent Howard Newman and Respondent Bek-New Chemist are charged with violating the provisions of Subsection 465.015(2)(c), Florida Statutes. Specifically, those parties are charged with selling or dispensing drugs without first being furnished with a prescription for the same and it is alleged that such conduct is violative of the provisions of Subsection 465.016(1)(e), Florida Statutes. The Petitioner thus seeks revocation of the pharmacy license and pharmacy permit held by Howard Newman and Bek-New Chemist for violation of those subsections. After the Respondents announced their intention to dispute the charges pursuant to Subsection 120.57(1) and request a formal hearing, the matter was referred to the Division of Administrative Hearings and was consolidated by a stipulation of the parties. The notice of this hearing was entered and served on all parties on February 25, 1983.
Further, the Respondents had actual notice of the hearing by telephone conference call with both parties and the Hearing Officer, which was held on May 24, 1983. The hearing was conducted as scheduled on May 25, 1983, in Miami, Florida. At that hearing the Respondent failed to appear after receiving proper notice. The Hearing Officer waited approximately 20 or 25 minutes before opening the proceedings in order to allow the Respondent additional time to arrive. The Respondent did not arrive and the Petitioner was allowed to put on its prima facie case. At the conclusion of its prima facie case, the Respondent had still not appeared and the hearing was thereupon adjourned. The Petitioner requested a transcript of the proceedings and timely filed its proposed findings of fact and conclusions of law on June 13, 1983.
The issue in these proceedings concerns whether the Respondents have violated the subsections with which they are charged in the Administrative Complaint and if that be the case, what penalty, if any, should imposed.
FINDINGS OF FACT
The Respondent, Howard Newman, is a pharmacist licensed in the State of Florida, holding license number 0014877. The Respondent, Bek-New Chemist, holds community pharmacy permit number 0006282. The Respondent practices pharmacy, and Bek-New Chemist is located, at 3690 Northwest 199th Street, Carol City, Florida 33054. Howard Newman is the owner and operator of Bek-New Chemist.
The Petitioner is an agency of the State of Florida charged with administering and enforcing the licensure standards and status of pharmacists and pharmacies in Florida and the regulation and enforcement of their standards of practice.
On August 26, 1980, Detective Kenneth Hackett of the Hialeah Police Department, pursuant to information received from a confidential informant, went with that informant to Bek-New Chemist Pharmacy, the Respondent's place of practice. Upon arriving in the parking lot of that establishment, the confidential informant pointed out to Detective Hackett a particular car which he said belonged to a black male by the name of "Howard." The informant told Detective Hackett that Howard would sell controlled drugs without a prescription. Detective Hackett thereupon gave his informant $20 in Hialeah Police Department "investigation funds" and instructed him to go inside and attempt to buy Darvon from the black male previously identified by the informant as "Howard." The informant then proceeded into the pharmacy, followed immediately thereafter by Detective Hackett. The informant identified the black male inside behind the counter as "Howard." Detective Hackett later checked the license number on the car identified as belonging to Howard, the individual in the pharmacy at the time, and identified by the informant, as being registered to the Respondent, Howard Newman. The informant, under the observation of Detective Hackett, engaged the individual identified by that means as the Respondent Howard Newman in a conversation. The Respondent went into the back room area of the pharmacy, returning a few minutes later and again conversing with the police informant. The Respondent then returned to the "back room" and returned with a medication container marked "Valium." The informant thereupon gave the Respondent the subject $20 in cash and the Respondent gave him the container. The container proved, after laboratory tests, the results of which are in evidence, to contain 60 Dextropropoxyphene tablets, commonly known as Darvon. Darvon is a scheduled, controlled drug, the dispensing of which must be accompanied by a prescription. The Respondent thus sold this controlled substance without being furnished a valid prescription or authorized refill therefor while the Respondent was licensed to practice pharmacy in this state.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the subject matter of and the parties to these proceedings, pursuant to Subsection 120.57(1), Florida Statutes (1981).
Pursuant to the provisions of Subsection 465.015(2)(c), Florida Statutes, it is unlawful for a person to sell or dispense drugs as defined in Section 465.003(7) without first being furnished a prescription.
Subsection 465.023(1)(c), Florida Statutes, then provides that:
The department or the board may revoke or suspend the permit of any pharmacy permittee who has violated any of the requirements of this chapter or any of the rules of the Board of Pharmacy; of Chapter 500, known as the "Florida Food,
Drug, and Cosmetic Law"; or of Chapter 893.
Dextropropoxyphene is a "medicinal drug" as defined in Subsection 465.003(7), Florida Statutes. The Respondents, Howard Newman and Bek-New Chemist (the pharmacy permittee wholly owned by Howard Newman), dispensed this medicinal drug without first being furnished with a prescription as required by the above authority. Such acts are thus violative of the provisions of Subsection 465.015(2)(c), Florida Statutes, and concomitantly, of Subsection 465.016(1)(e), Florida Statutes, which incorporates the provisions of Chapter 893, Florida Statutes, making a violation of those provisions also a violation of Chapter
465. Accordingly, it must be concluded that the Respondents, Howard Newman and Bek-New Chemist, are guilty of the violations charged in the Amended Administrative Complaint.
Having considered the foregoing Findings of Fact and Conclusions of Law, the evidence in the record and the candor and demeanor of the witnesses, it is
RECOMMENDED:
That the license of the Respondent, Howard Newman, and the community pharmacy permit of the Respondent Bek-New Chemist be revoked without prejudice to those Respondents reapplying for licensure and permitting upon a proper show of rehabilitation.
DONE and ENTERED this 23rd day of June, 1983, in Tallahassee, Florida.
P. MICHAEL RUFF Hearing Officer
Division of Administrative Hearings The Oakland Building
2009 Apalachee Parkway
Tallahassee, Florida 32301
(904) 488-9675
Filed with the Clerk of the Division of Administrative Hearings this 23rd day of June, 1983.
COPIES FURNISHED:
Bruce D. Lamb, Esquire Department of Professional Regulation
130 North Monroe Street Tallahassee, Florida 32301
Howard Newman
3690 Northwest 199th Street Carol City, Florida 33054
Wanda Willis, Executive Director Board of Pharmacy
Department of Professional Regulation
130 North Monroe Street Tallahassee, Florida 32301
Fred M. Roche, Secretary Department of Professional Regulation
130 North Monroe Street Tallahassee, Florida 32301
STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
DEPARTMENT OF PROFESSIONAL ) REGULATION, BOARD OF PHARMACY, )
)
Petitioner, )
)
vs. ) CASE NO. 82-2950
)
HOWARD NEWMAN, )
)
Respondent. )
)
NOTICE OF DEFAULT
The parties to the above-styled proceeding are hereby advised that a Recommended Order of Default has been entered against the Respondent, Howard Newman, by the undersigned Hearing Officer on June 23, 1983. Pursuant to Rule 28-5.211(2), the Respondent shall have fifteen (15) days in which to file a motion to set aside said default.
DONE and ENTERED this 23rd day of June, 1983, in Tallahassee, Florida.
P. MICHAEL RUFF Hearing Officer
Division of Administrative Hearings The Oakland Building
2009 Apalachee Parkway
Tallahassee, Florida 32301
(904) 488-9675
Filed with the Clerk of the Division of Administrative Hearings this 23rd day of June, 1983.
STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
DEPARTMENT OF PROFESSIONAL ) REGULATION, BOARD OF PHARMACY, )
)
Petitioner, )
)
vs. ) CASE NO. 82-2950
)
HOWARD NEWMAN, )
)
Respondent. )
)
RECOMMENDED ORDER OF DEFAULT
Pursuant to notice, this cause came on for formal hearing before P. Michael Ruff, duly designated Hearing Officer of the Division of Administrative Hearings, on May 25, 1983, in Miami, Florida.
APPEARANCES
For Petitioner: Bruce D. Lamb, Esquire
130 North Monroe Street Tallahassee, Florida 32301
For Respondent: No Appearance
Pursuant to an Administrative Complaint, filed September 30, 1982, the Petitioner, the Department of Professional Regulation, has charged the Respondent, Howard Newman, with violating the provisions of Subsection 465.016(1)(e), Florida Statutes, by virtue of an alleged violation of Subsection 893.07, Florida Statutes, in that that Respondent failed to keep proper records of scheduled controlled substances dispensed, as is required by that section.
This cause came on for hearing on May 25, 1983, pursuant to a Notice of Hearing served on both Petitioner and Respondent dated February 25, 1983, and pursuant to actual notice provided Petitioner' and Respondent in a telephone conference motion hearing on May 24, 1983. Upon convening the hearing, the Petitioner appeared and the Respondent was not present. The Hearing Officer waited approximately 20 to 25 minutes before convening the hearing to allow the Respondent to appear. The Respondent failed to appear. The Petitioner was allowed to put on its prima facie case at the end of which the Respondent had not yet appeared. Thereupon the hearing was adjourned. The Petitioner presented two witnesses and three exhibits, all of which were admitted into evidence.
The issue to be resolved in this proceeding is whether the Respondent has committed the violation alleged and, if so, whether any disciplinary action against his licensure status is warranted.
FINDINGS OF FACT
At all times pertinent hereto, the Respondent, Howard Newman, has held a license to practice pharmacy under the laws of the State of Florida, holding license number 0014877. At all times pertinent hereto, the Respondent's business address was 3690 Northwest 199th Street, Carol City, Florida 33054.
The Petitioner is an agency of the State of Florida charged with the administering and enforcing the licensure standards and status of pharmacists and pharmacies in Florida and the regulation and enforcing of their standards of practice.
On approximately August 27, 1982, Investigator McDonough of the Department of Professional Regulation conducted an audit of the drug and prescription records of the Respondent. The audit was initiated because of the large number of Dilaudid tablets being ordered on Drug Enforcement Administration Form 222 order forms from that pharmacy owned and operated by the Respondent. Investigator McDonough's audit demonstrated that there was a shortage of 9,609 four-milligram Dilaudid tablets and a shortage of approximately 122 two-milligram Dilaudid tablets for which prescription records were not available. The Respondent, on that date, could offer no explanation of the discrepancy the number of Dilaudid tablets ordered by the pharmacy and those for which prescription records existed. Pursuant agreement of the parties in a post-hearing telephone conference, the Respondent was allowed to submit late- filed Respondent Exhibit 1, consisting of additional prescription records he maintains were not available at the time of the investigation. Even with the prescriptions provided in Respondent's late-filed Exhibit 1, there remains a shortage of in excess of 8,000 four-milligram Dilaudid tablets which remain uncounted for. The Respondent has failed to maintain, on a current basis, a complete and accurate record of controlled substances received, sold, delivered or otherwise disposed of at his pharmacy, Bek-New Chemist.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the subject matter of and the parties to this proceeding. Subsection 120.57(1), Florida Statutes (1981).
Section 893.07, Florida Statutes, requires every person engaged in the compounding of or preparing of controlled substances to:
(b) On and after January 1, 1974, maintain, on a current basis, a complete and accurate record of each substance manufactured, received, sold, delivered or otherwise disposed of by him, except that this Subsection shall not require the main tenance of a perpetual inventory.
... [R]ecords shall be kept and made available for a period of at least two years for inspection and copying by law enforcement officers whose duty it is to enforce the laws of this State relating to controlled substances.
There is no question that the evidence establishes that the Respondent failed to keep proper records and failed to produce those records for the law enforcement officers whose duty it is to enforce the laws of this state related to controlled substances. The total number of Dilaudid four-milligram tablets appearing as a shortage pursuant to the audit conducted by the Petitioner is not explained by the production of prescriptions for four-milligram Dilaudid tablets which do not exceed 1,000 in number depicted on those prescriptions. Some of the prescriptions produced are dated outside of the audit period and therefore should not be considered as offsetting that shortage. Even the prescriptions provided as Respondent's late-filed Exhibit 1, when added to the prescriptions considered by the Petitioner's auditor, still reveal a shortage of over 8,000 four-milligram Dilaudid tablets for which no records are available and dispensing of which is unrecorded.
Subsection 465.016(1)(e), Florida Statutes, incorporates the provisions of Chapter 893 in their entirety and makes a violation of those provisions also a violation of Chapter 465 for which the penalties provided in subsection
465.016 (2) are applicable. The Respondent is thus in violation the provisions of Chapter 465 and Chapter 893 as incorporated by reference therein and as charged in the Administrative Complaint.
RECOMMENDATION
Having considered the foregoing Findings of Fact and Conclusions of Law, the evidence in the record and the candor and demeanor of the witnesses, it is
RECOMMENDED:
That the license of the Respondent, Howard Newman, be revoked, without prejudice to his reapplication for licensure upon a showing of rehabilitation.
DONE and ENTERED this 23rd day of June, 1983, in Tallahassee, Florida.
P. MICHAEL RUFF Hearing Officer
Division of Administrative Hearings The Oakland Building
1230 Apalachee Parkway
Tallahassee, Florida 32301
(904) 488-9675
Filed with the Clerk of the Division of Administrative Hearings this 23rd day of June, 1983.
COPIES FURNISHED:
Bruce D. Lamb, Esquire Department of Professional Regulation
130 North Monroe Street Tallahassee, Florida 32301
Howard Newman
3690 Northwest 199th Street Carol City, Florida 33054
Wanda Willis, Executive Director Board of Pharmacy
Department of Professional Regulation
130 North Monroe Street Tallahassee, Florida 32301
Fred M. Roche, Secretary Department of Professional Regulation
130 North Monroe Street Tallahassee, Florida 32301
STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
DEPARTMENT OF PROFESSIONAL ) REGULATION, BOARD OF PHARMACY, )
)
Petitioner, )
) CASE NOS. 81-1917
vs. ) 81-1918
) 82-2950
HOWARD NEWMAN and ) 84-3126
BEK-NEW CHEMIST, INC., )
)
Respondent. )
)
RECOMMENDED ORDER
Pursuant to notice this cause came on for formal hearing before P. Michael Ruff, duly designated Hearing Officer, on February 20, 1986, in Miami, Florida. The appearances were as follows:
APPEARANCES
For Petitioner: Bruce D. Lamb, Esquire
130 North Monroe Street Tallahassee, Florida 32301
For Respondent: Philip M. Schutzer, Esquire
Edgar Miller, Esquire 2435 Hollywood Boulevard Hollywood, Florida
Pursuant to four Administrative Complaints filed in the above-numbered cases (consolidated), the Department of Professional Regulation has charged the Respondents, Howard Newman and Bek-New Chemist, Inc. with violating Section 465.016(1)(e), 465.015(2)(c), 465.023(1)(c) and Section 893.07, Florida
Statutes. In these actions the Petitioner seeks to suspend, revoke or take other disciplinary action against the Respondents' license to practice pharmacy and permit to operate the pharmacy. Cases 81-1917 and 81-1918 were transmitted to the Division of Administrative Hearings in January, 1982 and set for hearing. The cause was continued without objection at the behest of the Petitioner and abated until such time as the Petitioner could file its complaint in Case 82- 2950. This case was transmitted to the undersigned Hearing Officer on or about November 18, 1982 and on February 25, 1983, after consolidation with the first two named cases, was set for hearing. The consolidated cases came on for hearing on May 25, 1983. The Respondents failed to appear at the hearing, and after waiting a reasonable time for them to appear, the Petitioner was allowed to go forward and put on its prima facie case. Thereafter, on June 23, 1983, a Recommended Order was entered in favor of the Petitioner recommending revocation of the license and permit. A Final Order was entered August 23, 1983, in which the Petitioner revoked the license and permit at issue.
The Respondents, in the meantime, had retained counsel and appealed that Final Order which included an appeal of the Petitioner's order on Respondent's Motion to Vacate default. Thereafter, by Opinion filed August 7, 1984, the District Court of Appeal for the Third District opining that "Appellant's failure to employ counsel to steer them through the procedural shoals should not be fatal to their appeal . . . " reversed the Final Order and directed the cause to be remanded for a hearing on the merits.
Pursuant to the Court's Mandate, the cases were transmitted back to the Division including Case No. 84-3126. Case No. 84-3126 is a case not previously transmitted to the Division inasmuch as no responsive pleading or election of rights had been filed. However, inasmuch as the Respondent evidenced his intent to dispute the material allegations of fact therein, the Petitioner requested that case also be assigned a DOAH case number and be consolidated with the other three cases which had been remanded. The cases were duly assigned to the undersigned Hearing Officer and reset for hearing after discovery was engaged.
After a number of procedural delays, including the dissolution of Respondents' counsel's law firm and withdrawal and substitution of Respondents' counsel, the parties agreed upon a hearing date and the cause was set for hearing on May 2, 1985. Thereafter, upon Respondents' motion, by agreement of the parties, the cause was continued and placed in abeyance until the parties advised the Hearing Officer that the cases were in a posture to proceed. The cause was set for hearing once more in January 1986 and continued by stipulation, such that the cause finally came on for hearing on the above-mentioned date.
The complaints and amended complaints in essence charge that the Respondents failed to maintain a current, complete and accurate record of controlled substances which Respondents received, sold, delivered or otherwise disposed of at the Bek-New Chemist Pharmacy as allegedly revealed by a drug accountability audit covering the period January 1, 1981 to August 13, 1982.
See Section 893.07, Florida Statutes. Additionally, it is charged that the Respondent Howard Newman, the sole owner of the Respondent corporation permittee, filled and dispensed sixty propoxyphene, also known as dextropropoxyphene or Darvon, a controlled substance, to a Dade County police informant. He was observed by a detective of the Dade County Department of Public Safety. Based upon this alleged conduct, the Respondent Howard Newman and the permit holder Respondent, Bek-New Chemist, Inc., have been charged with violations of the above cited statutory authority.
The Petitioner presented the testimony of John McDonough, Martin Wolary, Kenneth Hackett, Hugh Fitzpatrick, Harry Coleman, and Vernon Bell. The Petitioner offered Exhibits 1-7 which were admitted into evidence. The Respondents offered the testimony of Howard Newman, Philip Schutzer, Thomas Bowleg, and Elizabeth Newman. Respondent's Composit Exhibit 1 was offered and admitted into evidence.
At the conclusion of the hearing, the parties requested a transcript of the proceedings which was duly filed with the Hearing Officer. The parties were accorded the right to file proposed findings of fact and conclusions of law.
The Petitioner timely filed proposed findings of fact and conclusions of law, the Respondent did not. The Petitioner's Proposed Findings of Fact and Conclusions of Law are treated and disposed of in this Recommended Order and additionally are ruled on with specific reference in the Appendix attached hereto and incorporated by reference herein.
The issues to be resolved in this proceeding concern whether the Respondent's have committed the conduct alleged, whether that conduct constitutes a violation of the statutory authority pled in the complaint and if so whether any disciplinary action is warranted.
FINDINGS OF FACT
The Respondent Howard Newman, at all times pertinent hereto, has held a license to practice pharmacy under the laws of Florida, holding license number 0014877. The Respondent Bek-New Chemist, Inc., is a corporation which operates a community pharmacy at which the Respondent Howard Newman practices pharmacy and which holds permit number 0006282. Respondent Howard Newman's business address at times pertinent hereto was 3690 N.W. 199 Street, Carol City, Florida. The Respondent Bek-New Chemist, Inc., operates at that same address. The Petitioner is an agency of the State of Florida charged with administering and enforcing the statutes and rules governing the practice of pharmacy, the operation of pharmacies in Florida and the licensure and practicing standards of pharmacists.
Shortly before August 26, 1980, Detective Kenneth Hackett, then of the Hialeah Police Department, received information from a confidential informant that an individual named "Howard" working at the Bek-New Chemist Pharmacy would sell controlled substances without a prescription. Thereafter, on August 26, 1980, Detective Hackett, after receiving authorization from his superiors, went with the confidential informant to the Bek-New Chemist address. Upon arriving in the parking lot of that establishment, the confidential informant pointed out to Detective Hackett a particular car which he said belonged to a black male by
the name of "Howard." The informant told the detective that Howard was the individual who would sell the controlled substances without a prescription. Detective Hackett gave the informant $20 in "investigative funds" and searched the informant to ensure that he did not have any controlled substances or a prescription on his person or in his possession. At Detective Hackett's behest, the informant then proceeded into the pharmacy accompanied by Detective Hackett. Under the observation of Detective Hackett, who had placed himself where he could observe the informant and any individual he might converse with, the informant engaged the individual whom the informant identified as "Howard" in a conversation. The individual identified as Howard went to the rear or back room of the pharmacy and returned to the pharmacy window and conversed with the confidential informant for a moment and then returned to the back room. When he came back to the pharmacy window he had a white medicine bottle which he placed in a brown paper bag and handed to the confidential informant. The confidential informant then handed that individual a $20 bill. The confidential informant presented no prescription or other paper to the man at the pharmacy window.
Upon returning to Officer Hackett's vehicle, the informant handed the bag to him. Officer Hackett opened the bag and observed a white plastic pill bottle which contained approximately 60 capsules which appeared to be Darvon. At that point Officer Hackett returned to the police station, placed them in an evidence bag, sealed them for evidentiary purposes and they were duly transmitted in the regular course of business to the Dade County Crime Lab for
an analysis. The Crime Lab chemist analyzed the capsules and reported that they were propoxyphene or "Darvon."
The individual who sold the Darvon to the confidential informant was working as the pharmacist at the pharmacy window at the time the informant and Officer Hackett approached him. That person was identified as "Howard" by the confidential informer. Howard Newman owned the Pharmacy and worked there as its pharmacist. Officer Hackett noted the license tag number of the car, mentioned by the informant as belonging to "Howard," and checked its registration. It was registered to the ownership of Howard Newman.
Officer Hackett returned to the station with the Darvon, gave it to the station's evidence clerk, who transmitted it to a clerk at the Crime Lab in downtown Miami. It was then given to the chemist who performed the analysis. After analysis it was transmitted back to Officer Hackett and placed in the evidence room or locker under seal. Mr. Coleman, the chemist who performed the analysis, testified and established the substance to be propoxyphene or Darvon. Respondent maintains that the Petitioner failed to establish a continuous possession of the contraband from the time of purchase until the time of analysis. However, the chain of custody of the Darvon in question appears to have been according to normal police professional standards and practices.
There is no evidence that any party or person tampered with the Darvon from the moment of purchase until it was analyzed and transmitted back to Officer Hackett, and secured in his station's evidence room. 1/
Thus Howard Newman, the Respondent herein, was the individual who sold the Darvon without a prescription. There is no question that the substance he sold to the confidential informant was Darvon or propoxyphene. There was no prescription exchanged for the Darvon, just money. There was no showing of any likelihood that the Darvon was dispensed on the basis of an earlier prescription, as a refill. Finally, it has been established that the Respondent Bek-New Chemist, Inc., by these operative facts, also entered into the sale of a controlled substance, through its principal owner, Newman, without a prescription being obtained therefor.
THE DILAUDID AUDIT
On August 13, 1982, investigators for the Department of Professional Regulation visited Bek-New Chemist Pharmacy and requested that the Respondents produce records of sales of Dilaudid during the audit period at issue, which was January, 1981 through August 13, 1982. Investigators McDonough and Wolary informed the Respondent of the purpose of the visit and the Respondent provided them with prescription records related to two milligram and four milligram Dilaudid tablets and capsules, upon which substances the audit was focused. Dilaudid is a schedule II controlled substance and, as such, is a substance with a high potential for drug abuse. It has a currently accepted, but highly restricted medical use in the United States. Because of the high potential for abuse and according to the provisions of Chapter 893, Florida Statutes, schedule II drug records are required to be kept separately from all other pharmacy records.
Investigator Wolary conducted the audit essentially by determining, from contact with the drug wholesale companies who supplied the Respondents and review of the Drug Enforcement Administration records those suppliers are required to keep, the total number of two milligram and four milligram Dilaudid tablets and capsules which the Respondents had purchased. He then compared that total number with the prescription records supplied him by the Respondent indicating the total amount they had sold pursuant to appropriate prescriptions. He determined that there was a shortage of 9,606 four milligram Dilaudid tablets and 122 two milligram Dilaudid tablets. Due apparently to prescriptions supplied later by the Respondents he determined that the shortage of four milligram Dilaudid tablets, the sale of which was not supported by valid prescription records, was in reality 9,309 tablets, instead of 9,606. On August 27, 1982, the Respondents were advised of the results of the audit, which indicated that the Respondents had not accounted for this large quantity of the drug.
Subsequent to the audit and indeed after the first hearing held in these cases, the Respondents on June 6, 1983 produced a late-filed exhibit consisting of some additional prescriptions purportedly for Dilaudid, representing them to have been filled at the Bek-New Chemist Pharmacy. These prescriptions were produced in an effort to account in part for the total quantity of missing Dilaudid. Additionally, the Respondent purportedly gave prescriptions on two occasions to Mr. Schutzer, his counsel, during the interim between the first and second hearings in this cause, purporting to explain or show the appropriate disposition of additional amounts of the unaccounted for Dilaudid. Mr. Schutzer was called to testify on behalf of the Respondent in this regard by his co-counsel, Mr. Miller. Mr. Schutzer established that these prescriptions were kept in his office and that he did a compilation of them showing the total number of Dilaudid tablets and/or capsules they represented. Mr. Schutzer testified that on or about April 16, 1985, those prescriptions were to have been photocopied, presumably for the benefit of Petitioner's counsel, but before that was accomplished, his office was burglarized and the prescriptions were stolen from his office on the evening of that day. Mr. Schutzer or his firm filed a police report concerning the burglary. In any event, Mr. Schutzer's testimony establishes that his compilation of the drugs, represented by those prescriptions, when viewed most favorably to Respondents, accounts for only 4,512 tablets and/or capsules. The prescriptions were from the period January, 1981 through August, 1982 and therefore closely corresponded to the audit period in question.
The Respondent testified that he and his store suffered a robbery in May of 1981. On the evening before the robbery, a hole had been cut in the roof directly over the prescription desk or counter. The Respondent maintained he kept some of the schedule II prescriptions in a separate file, but others were bound in rubberbands on the desk directly under the hole. A rainstorm purportedly occurred that night which wet and rendered illegible many of the prescriptions.
The robbery occurred when he and his wife were present in the store the next day. The Respondent suffered a head injury in the robbery and was hospitalized for approximately two weeks thereafter. During this time, his wife went into the store and attempted to clean up the scattered pills and papers, including prescriptions that were either scattered by the robber or damaged by water. The Respondent maintains that some drugs were "ransacked", but does not know which ones or how many, nor does he know what type of prescriptions were lost or destroyed either by the water damage or by his wife cleaning up the store in his absence. The Respondent attempted to account for "missing" drugs by stating that certain drug prescriptions can be refilled five times or for six months (whichever occurs first) without a new prescription having to be issued by a physician. He acknowledged on cross examination however, that that refilling authority only refers to schedule III, IV and V drugs and the drug at issue, Dilaudid, is a schedule II drug to which that refilling authority does not apply. The Respondent finally maintains that he filed drug enforcement administration "lost forms" and made a police report concerning the robbery, but then contends that the "police did not turn it in." Presumably he means the police did not make a record of or pursue investigation of the reported robbery.
The Respondent's wife and Thomas Bowleg, a contractor hired to fix the hole in the roof, established that a robbery did indeed occur and the hole in the roof was above the desk or counter where prescriptions were kept. Thus, it may be that indeed some prescriptions were water damaged, scattered or destroyed by the robbery. In any event, the Respondent failed to establish that the prescriptions allegedly damaged or destroyed, or otherwise not available, were for Dilaudid, that they related to the same audit period, nor even that any of them were for schedule II drugs.
The Hearing Officer finds it singularly curious that the prescriptions supposedly in the possession of Mr. Schutzer disappeared as the result of a burglary during the pendency of this proceeding. Be that as it may, Mr. Schutzer's own compilation only accounts for 4,512 pills. Assuming that all the prescriptions represented by that number were within the audit period and therefore arguably relevant, it was not shown that all of them came from the
Bek-New Chemist Pharmacy as opposed to the Respondent's other pharmacy which he owns and operates. Thus it was not established that they are all related to the same quantity of Dilaudid purchased for resale by the Bek-New Chemist Pharmacy and Howard Newman which is the subject of the instant audit.
In this connection, Vernon Bell was accepted as an expert in pharmacy and pharmacy practice. He is the administrator of investigative services for the Petitioner and has inspected and audited "thousands of pharmacies." The Respondent testified that his stamping machine was defective and that he hand wrote prescription numbers on some prescriptions, as that relates to his position that many of these prescriptions should have been included in the audit in partial justification of the shortage. Mr. Bell, however, established that in situations such as this it is common for prescriptions from other pharmacies under the access and control of such a Respondent to be used to attempt to cover shortages by renumbering those prescriptions to sequentially fit them into the
list of prescriptions from the relevant audit period in an attempt to support more of the missing drugs with prescriptions justifying their dispensation. It was not clearly explained why the Respondent hand wrote some prescription numbers on the prescriptions in these exhibits when he had a second stamping machine to stamp prescription numbers and in view of this and the Respondent's somewhat equivocal, selective memory evinced by his testimony, for instance, that he first knew of the Dilaudid shortage on the day of the first hearing herein and his testimony a short time later that he remembered Mr. McDonough telling him of the Dilaudid shortage during the investigation, the Respondent's testimony cannot be accorded significant credence. Neither does Mr. Schutzer's testimony have any significant probative value since he was unable to testify whether the prescriptions reportedly given to him by Mr. Newman which were then purportedly stolen, came from the Bek New Chemist Pharmacy involved in the audit or from another pharmacy such as the other one owned by the Respondent which is not the subject of the audit.
Further, with regard to the prescriptions supplied by the Respondent as a late exhibit after the original hearing; although those prescriptions are purportedly for Dilaudid and are represented to have been filled at the Bek-New Chemist Pharmacy, a number of them, have been altered and should be disregarded as justification for any of the quantity of missing Dilaudid. These prescriptions were supplied by the Respondent from his custody and control and are further reason for according his testimony scant credibility.
In this connection, prescription number 69773, dated January 2, 1981, for one Margaret Hamlin bears two drug names on the single prescription blank. The second drug depicted, Dilaudid, is in a different color ink from the first drug, Premarin, which is a medicinal drug and not a controlled substance. The Respondent acknowledged this fact upon cross-examination. 2/
Prescription number 69413 bearing the date November 11, 1982, should not be considered because it falls outside of the audit period for which the Dilaudid is unaccounted for. In addition, as acknowledged by the Respondent, that prescription is not clearly legible and could have been altered in that it appears to have been written for the drug Dilantin originally, instead of for Dilaudid.
Prescription numbers 76189 and 76190 dated January 25, 1985, for patient Calvin Hawkins also contains prescriptions for two different drugs. Again, the second prescription for Dilaudid is in a different color ink than the remainder of the prescription indicating that it was added later and not authorized by the doctor issuing the prescription.
Finally, on cross-examination, the Respondent Newman testified, regarding the prescriptions purportedly given Mr. Schutzer, that some of the prescriptions were indeed outside of the audit period. Therefore, an indeterminate number of the 4,512 tablets or capsules purportedly accounted for by Mr. Schutzer's testimony are indeed not actually accounted for. Neither the Respondent nor Mr. Schutzer demonstrated that all of the prescriptions presented to Mr. Schutzer or presented in the late exhibit to the Hearing Officer and Petitioner's counsel, after the first hearing, actually came from the Respondent's pharmacy, Bek-New Chemist. Therefore, these prescriptions do not constitute adequate justification for reducing the number of unaccounted for Dilaudid tablets and capsules established by the above-named investigators.
In any event, regardless of whether these prescriptions supplied in the late exhibit or those supplied to Mr. Schutzer actually came from Bek-New Chemist and were filled during the audit period, it is clear that the Respondents have failed to maintain, on a current basis, a complete and accurate record of controlled substances received and dispensed. This failure is especially serious in view of the highly abusable nature of Dilaudid as a schedule II controlled substance. It has further been established that the Respondent Newman and Bek-New Chemist have dispensed Darvon without a required prescription. The testimony of Officer Hackett coupled with that of the Chemist, Harry Coleman, establishes that the sample analyzed by Mr. Coleman was in fact the same sample obtained by Officer Hackett and the confidential informant from the person identified as Howard Newman, the Respondent, and that the substance was propoxyphene or Darvon.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the subject matter of and the parties to these proceedings. Section 120.57(1), Florida Statutes.
Under the provisions of Subsection 465.015(2)(c), Florida Statutes: "(c) It is unlawful for any person, to
sell or dispense drugs as defined in Section
465.003(7), without first being furnished with a prescription."
Section 465.016(1)(e), Florida Statutes, provides: "(1) The following acts shall be grounds
for disciplinary action set for in this section:
(e) Violating any of the requirements of this chapter; . . .; or Chapter 893."
Section 465.023(1)(c), Florida Statutes, provides: "(1) The Department or the Board may
revoke or suspend the permit of any pharmacy permittee, and may fine, place on probation, or otherwise discipline any pharmacy permittee who has.
(c) Violated any of the requirements of
this chapter or any of the rules of the Board of Pharmacy . . . ; or of Chapter 893;"
Section 893.07(1)(b), Florida Statutes, provides in pertinent part:
"(1) Every person who engaged in the . dispensing . . . of controlled substances shall:
(b) On or after January 1, 1974,
maintain, on a current basis, a complete and accurate record of each substance . . . received, sold, delivered, or otherwise disposed of by hand, except that this subsection shall not require the maintenance of a perpetual inventory.
Section 893.07(4), Florida Statutes, in turn provides: "(4) Every inventory or record required by
this chapter, including prescription records, shall be maintained:
Separately from all the records of the registrant, or
Alternatively, in the case of
schedule 3, 4, or 5 controlled substances, in such form that information required by this chapter is readily retrievable from the ordinary business records of the registrant. In either case, records shall be kept and made available for a period of at least two years for inspection and copying by law enforcement officers whose duty it is to enforce the laws of this state relating to controlled substances."
Darvon is a brand name for propoxyphene, also known as dextropropoxyphene. It is a medicinal drug and therefore, pursuant to the definition appearing at Section 465.003(7), Florida Statutes, is a drug which requires a prescription from a physician authorizing its dispensation.
The Petitioner herein is seeking to potentially suspend or revoke the Respondents' licenses and thus the Respondent Howard Newman's right to practice his livelihood. Thus the burden of proof in this case must be born by the Petitioner. Balino v. Department of Health and Rehabilitative Services, 348 So.2d 349 (Fla. 1st DCA 1977). This is an action penal in nature and the potential severe penalty involved dictates that Petitioner must prove the violations alleged by clear and convincing evidence. State ex rel. Vining v. Florida Real Estate Commission, 281 So.2d 165 (Fla. 1973). The above findings of fact and the evidence of record clearly show that the Petitioner has met that burden.
There is no question that the Respondents Howard Newman and Bek-New Chemist dispensed Darvon without first being furnished with a prescription in violation of the above authority. Detective Hackett established that he went to the pharmacy with a confidential informant who identified the car parked in the lot as belonging to a black male by the name of "Howard", telling Hackett that Howard was the individual who would sell controlled substances without a prescription. Thereupon, the informant went into the pharmacy under Hackett's observation and bought the controlled substance Darvon without a prescription from the man identified as Howard. Detective Hackett later investigated the tag number on the car pointed out to him by the informant and it was registered to the Respondent, Howard Newman. Given the totality of the circumstantial evidence of record, there is no doubt that the Respondent was the individual who sold the Darvon to the confidential informant under Detective Hackett's observation, without a prescription.
There is no question, given the above findings of fact and the evidence of record, that the substance purchased by the confidential informant and delivered to Detective Hackett was propoxyphene or Darvon. Detective Hackett established, as did Mr. Coleman, the chemist who analyzed the drug, that the chain of custody and possession was unbroken and that the drugs followed the proper, professional police channels from the officer who obtained the drug sample to the chemist at the lab and back to that officer and the evidence room or locker at his duty station. In Bernard v. State of Florida, 275 So.2d 234
(Fla. 3rd DCA 1973), the Court discussed the chain of custody of a controlled substance and held that "the test is whether or not there was an indication of probable tampering with the evidence." In the instant case there has been no evidence of any tampering with the evidence consisting of the Darvon sample.
The testimony of Detective Hackett, when coupled with that of Chemist Coleman, establishes that the sample analyzed by Coleman was in fact the same sample obtained by Hackett and was not altered or tampered with. It also establishes without doubt that the sample was indeed Darvon which requires a prescription for dispensation. Although the Respondents contend that the Darvon was dispensed as a refill of a previously submitted prescription, it failed to produce any such prescription which should have been in its possession which could legitimize the dispensing of the Darvon.
Section 893.07, Florida Statutes, places an affirmative duty on persons engaging in the dispensing of controlled substances, to maintain on a current basis complete and accurate records of that dispensing. Those records must be readily retrievable and produceable for inspection. Dilaudid has a high potential for abuse. Records of it must be kept separately from all other pharmacy records. The investigators for the Petitioner asked the Respondent to produce all records of sales of Dilaudid in the audit period mentioned above. Although some of the prescriptions were produced, the audit was conducted and it was thus established that Respondents could not account for large quantities of Dilaudid, as many as 9,309 tablets. Although the Respondent and Mr. Schuzter maintain that there were other prescriptions (and a robbery) in explanation of part of the discrepancy between the number of Dilaudids missing and the number of prescriptions, Mr. Schutzer did not establish that those other prescriptions formerly in his possession actually came from or were filled by the Bek-New Chemist Pharmacy and the Respondent, nor that all those prescriptions fall inside the audit period. In view of the above findings of fact, the audit results have been established to be correct in terms of the shortage of Dilaudid at the Bek-New Chemist Pharmacy.
The audit results aside, it is clear that the Petitioner has established that the Respondents failed to maintain, on a current basis, a complete and accurate record of controlled substances received and dispensed. The Respondent quite obviously does not have readily at hand all his prescription records for Dilaudid and when some prescriptions were apparently destroyed or damaged by water and a robbery, he did not take appropriate steps to restore or reconstruct his prescription records. This is a serious breach of appropriate practice standards delineated in Chapter 465, Florida Statutes, when it relates to Dilaudid, which is a highly abused and abusable controlled substance.
In view of the above findings of fact and the competent, substantial evidence of record, it is concluded that the Respondent Howard Newman and the Respondent Bek-New Chemist have dispensed Darvon, a medicinal drug without a prescription in violation of Subsection 465.015(2)(c) and therefore Respondent Newman has derivatively violated Section 465.016(1)(e), which renders it a separate violation for a Respondent to have violated any provision of Chapter 465, Florida Statutes. Respondent Bek- New Chemist has violated the provisions of Section 465.023(1)(c), Florida Statutes, by violating a provision of Chapter
465 and in addition both Respondents Newman and Bek-New Chemist have failed to keep accurate records of controlled substances received and dispensed in violation of Section 893.07, Florida Statutes. Thus, Respondent Newman has also violated the provisions of Section 465.016(1)(e) by violating a provision of Chapter 893, Florida Statutes. Respondent Bek-New Chemist has violated the provisions of Section 465.023(1)(c) in this regard as well. Accordingly, all
the charges in the Administrative Complaints have been supported by clear and convincing evidence. It is concluded that the Respondent is guilty of the conduct and statutory violations charged.
RECOMMENDATION
Having considered the foregoing Findings of Fact and Conclusions of Law, the evidence of record and the candor and demeanor of the witnesses, it is
RECOMMENDED:
That the pharmacy license of Howard Newman be revoked;
That the pharmacy permit held by Bek-New Chemist, Inc. be also revoked. DONE and ENTERED this 31st day of July, 1986, in Tallahassee, Florida.
P. MICHAEL RUFF Hearing Officer
Division of Administrative Hearings The Oakland Building
2009 Apalachee Parkway
Tallahassee, Florida 32301
(904) 488-9675
Filed with the Clerk of the Division of Administrative Hearings this 31st day of July, 1986.
ENDNOTES
1/ Respondent's position is not consistent with the Opinion of the Third District Court of Appeal in Bernard vs. State of Florida, 275 So.2d 34 (Fla. 3rd DCA 1973). The Court in that case in discussing the chain of custody of controlled substances held that the test concerns whether there was an indication of probable tampering with the evidence. In the instant case Respondent has shown no evidence of probable tampering.
2/ Section 893.02(15), Florida Statutes, provides that: "a prescription ordered for controlled substance will not be issued on the same prescription blank as another prescription order for a controlled substance which is named or described in a different schedule, nor shall any prescription order for a controlled substance be issued on the same prescription blank as a prescription order for a medicinal drug . . . which does not fall within the definition of a controlled substance as defined in this act." Thus it appears that the second drug Dilaudid was inserted on the prescription after the issuance of the original prescription for the medicinal drug and therefore that prescription should be disregarded as justification for the quantity of unaccounted for Dilaudid since the Dilaudid depicted thereon was not apparently authorized by the doctor and is a bogus prescription.
APPENDIX TO RECOMMENDED ORDER
Petitioner's Proposed Findings of Fact
Accepted
Accepted
Accepted
Accepted
Accepted
Accepted
Accepted
Accepted
Accepted
Accepted
Accepted
Accepted
Accepted
Accepted
Accepted
Accepted
Accepted
Accepted
Accepted
Accepted
COPIES FURNISHED:
Bruce D. Lamb, Esquire
130 North Monroe Street Tallahassee, Florida 32301
Philip M. Schutzer and Edgar Miller
2435 Hollywood Boulevard Hollywood, Florida
Fred Roche, Secretary Department of Professional
Regulation
130 North Monroe Street Tallahassee, Florida 32301
Wings Slocum Benton, Esquire General Counsel
Department of Professional Regulation
130 North Monroe Street Tallahassee, Florida 32301
Rod Presnell, Executive Director Board of Pharmacy
Department of Professional Regulation
130 North Monroe Street Tallahassee, Florida 32301
| Issue Date | Proceedings |
|---|---|
| Jun. 23, 1983 | Recommended Order (hearing held , 2013). CASE CLOSED. |
| Issue Date | Document | Summary |
|---|---|---|
| Aug. 23, 1983 | Agency Final Order | |
| Jun. 23, 1983 | Recommended Order | Respondent is guilty of dispensing controlled substances without prescription and failing to properly maintain dispensing records. Revocation recommended. |
