Findings Of Fact Based upon the entire record, the following findings of fact are determined: Background At all times relevant hereto, respondent, Obi E. Enemchukwu, was licensed as a pharmacist having been issued license number PS 0023082 by petitioner, Department of Professional Regulation, Board of Pharmacy (Board). He has been licensed as a pharmacist since 1981. There is no evidence that respondent has been the subject of disciplinary action prior to this occasion. When the events herein occurred, respondent was the designated prescription department manager and pharmacy permittee for Oviedo Drug World (ODW), a community pharmacy located at 83 Geneva Drive, Oviedo, Florida. A community pharmacy is not defined by statute or rule. However, a Board witness described such a pharmacy as being a drug store that serves customers in an outpatient or ambulatory setting. As the prescription manager for the pharmacy, respondent was responsible for maintaining all drug records, providing for the security of the prescription department, and following all other rules governing the practice of pharmacy. Count I This count alleges that respondent violated a Board rule by virtue of the ODW prescription department being "opened at 9:00 a.m. with a pharmacy technician only on duty with no pharmacist present until approximately 9:15 a.m.". In this regard, the evidence shows that on February 28, 1991, a DPR senior pharmacist, Charles C. Lewis, made a routine inspection of ODW. He entered the premises at approximately 9:00 a.m. and found the drug store open, the lights on in the pharmacy section, and only a pharmacist technician on duty. Respondent was not on the premises. Respondent eventually entered the premises around 9:10 a.m. Because the law requires that a registered pharmacist be on duty whenever a community pharmacy is open, respondent, as the designated manager, was in contravention of that requirement. Count II The second count alleges that "on one occasion in approximately August 1990, pharmacist technicians on duty were required to dispense medicinal drugs despite no pharmacist having been present". As to this charge, respondent admitted without further proof that the allegations were true. Thus, the charge in Count II has been sustained. Count III The third count alleges that "on at least two occasions refills for medicinal drugs were dispensed without authorization from the prescribing physician." As to this count, during the course of his inspection of ODW's prescription file, Lewis found copies of two original prescriptions dispensed by respondent on Saturday, February 9, 1991, and Saturday, February 16, 1991, respectively. Original prescriptions are those either handwritten by a doctor and brought in for filling by the patient or those that are telephoned in to the pharmacy by the doctor's office. If a prescription is telephoned in, it must be immediately reduced to writing by the pharmacist. Original prescriptions do not include refills. In this case, the two prescriptions were the type telephoned in by the doctor directly to the pharmacy. Because doctors are rarely in their offices on Saturday, Lewis turned the prescription records over to DPR for further investigation. The records of the prescriptions have been received in evidence as a part of petitioner's exhibits 1 and 2. The prescriptions indicate that Dr. James E. Quinn prescribed thirty Nalfon tablets (600 mg.) to patient L. C. on February 9, 1991, and Dr. Michael E. Meyer prescribed ten Tagamet tablets (300 mg.) to patient J. K. on February 16, 1991. The record does not disclose whether the drugs are scheduled legend drugs or non-scheduled legend drugs. Deposition testimony given by Drs. Quinn and Meyer established that neither doctor authorized by telephone or in writing that the two prescriptions in question be filled. Respondent concedes that he dispensed the drugs, and by doing so, he violated the law. Count IV The final count alleges that respondent, as a pharmacy permittee, violated former rule 21S-1.023 (now renumbered as rule 21S-28.112) by dispensing a medicinal drug in violation of state law. Because this charge is founded on the same set of facts set forth in findings of fact 4, 5 and 6, it is found that this charge has been sustained. Mitigation and Penalty At hearing, respondent generally offered mitigating testimony. As to Count I, he indicated he planned to arrive at the store at 9:00 a.m. but an automobile accident tied up traffic and caused him to be ten minutes late. He suspects that the store owner, who had the only other set of keys, opened up the store and pharmacy area and improperly let the technician into the pharmacy area even though respondent had not yet arrived. As to Count II, respondent acknowledged that two prescriptions were dispensed by pharmacy technicians without a pharmacist on duty but believes the store owner authorized the technician to dispense two prescriptions that he had filled the previous evening. He says appropriate instructions have been given to insure that this will not occur again. Finally, respondent gave the following explanation for dispensing the two prescriptions without authorization from a doctor. During the time period in question, respondent had a practice of partially filling prescriptions. In other words, even though a prescription might authorize a total of 100 tablets, respondent would dispense them piecemeal (e.g., 10 at a time) over the life of the prescription. Thus, at the end of the prescription period, if only 80 of 100 tablets had been previously dispensed, he would fill the remaining 20 tablets even though the prescription from a particular doctor had expired. In the case of the two prescriptions in issue, respondent believes that the customers either had a valid prescription from another doctor but he inadvertently refilled the prescription using the former doctor's name because the prescription had not been used up, or he noted that the patient had not been given the total number of tablets authorized under the original prescription. However, no documentation was submitted by respondent to support the claim that he was presented with a new valid prescription by one of the customers. Respondent apparently no longer engages in this practice. Finally, throughout the course of this proceeding, respondent has fully cooperated with the Board. Although the Board did not submit a proposed order containing a recommended penalty, at hearing counsel for the Board suggested that respondent's conduct warrants the imposition of a fine, probation and a reprimand.
Recommendation Based upon the foregoing findings of facts and conclusions of law, it is RECOMMENDED that respondent be found guilty of violating Sections 465.014, 465.015(2)(c), 465.016(1)(e)and (n), and 465.023(1)(c), Florida Statutes (1989), and that he be given a reprimand, fined $500 and his license placed on probation for one year. DONE and ENTERED this 12th day of March, 1992, in Tallahassee, Florida. DONALD R. ALEXANDER Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, FL 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 12th day of March, 1992. COPIES FURNISHED: Tracey S. Hartman, Esquire 1940 North Monroe Street, Suite 60 Tallahassee, FL 32399-0792 Obi E. Enemchukwu P. O. Box 32 Tavares, FL 32778-0032 Jack L. McRay, Esquire 1940 North Monroe Street, Suite 60 Tallahassee, FL 32399-0792 John Taylor, Executive Director Board of Pharmacy 1940 North Monroe Street Tallahassee, FL 32399-0792
The Issue The issues to be resolved in this proceeding concern whether the Respondent properly maintained and supplied required records to support and document prescription claims, which it billed to Medicaid and for which it received payment from the Medicaid program during the audit period of April 1, 2000 through December 31, 2001. If that is not the case, it must be determined whether the Agency is entitled to recoup from the Respondent the sum it seeks of $108,478.77, as the purported amount overpaid to the Respondent by the Agency. It must also be determined whether the applicable laws and regulations referenced herein were complied with by the Respondent, in terms of its accepting and filling prescriptions, dispensing relevant drugs, and recording and documenting such activities in its pharmacy records. Finally, it must be determined whether the statistical methodologies employed by the Agency, through its audit and investigation of the Respondent, were sufficiently representative and accurate so as to support the calculation of estimated overpayments.
Findings Of Fact The Petitioner is an Agency of the State of Florida charged by the statutes and rules referenced herein with ensuring that proper reimbursement is effected to providers, including pharmacies, by the Medicaid system. Because of its duty to enforce and regulate the Medicaid system, the Petitioner Agency has an audit and oversight function, as well as an enforcement function, to ensure that Medicaid payments and the general operations of the Medicaid system are carried out correctly. It is through this duty imposed by the cited Florida Statutes and rules, as well as the federal regulations it is charged with enforcing, that the Petitioner carried out an audit of the Respondent, Brown Pharmacy, concerning the audit period of April 1, 2000 through December 31, 2001. The Petitioner conducts audits of providers such as Brown in order to ensure compliance with the Medicaid provisions and Medicaid provider agreements. These are called "integrity audits" and are routinely performed by auditors contracted from private firms such as Heritage. Brown Pharmacy (Brown) is licensed in the State of Florida as a pharmacy (license Number PH562). Brown maintained a business location at 312 West 8th Street, Jacksonville, Florida 32206, at times pertinent to this case. During the audit period Brown was an enrolled Medicaid provider authorized to provide Medicaid prescriptions pursuant to a provider agreement with the Agency. The terms of the provider agreement governed the contractual relationship between Brown and the Agency. Pursuant to that provider agreement, Brown was to maintain the Medicaid-related records and documentation for at least five years. Any Medicaid provider, such as Brown, not in compliance with the Medicaid documentation and record retention policies may be subject to the recoupment of Medicaid payments. During the audit period, Brown dispensed prescription drugs to Medicaid recipients. Medicaid claims were filed and paid electronically as "point of sale" transactions during the audit period. Each claim reviewed and at issue in this case was a paid Medicaid claim subject to the provider agreement and pertinent regulations. As a condition of participating in the Medicaid program, a Medicaid provider must comply with all provisions of a provider agreement, which is a voluntarily agreement between the Agency and the provider. Those provisions include the provider's agreement to comply with all relevant local, state and federal laws, rules, regulations, licensure laws, bulletins, manuals, and handbooks, etc. The provider must agree to keep and maintain, in a systematic and orderly manner, all Medicaid- related records as may be required by the Agency and make them available for state and federal agencies and review. It must maintain complete and accurate medical, business, and fiscal records that will justify and disclose the extent of goods and services rendered to customers or patients and rendered as billings to the Medicaid system. Florida Administrative Code Rule 59G-4.250 promulgates, as part of the rule, the above-referenced handbook (handbook) which sets out Medicaid polices and rules. The polices and rules govern the rights and responsibilities of drug providers, such as Brown, including coverage and payment methodologies for services and goods rendered to Medicaid recipients and billed to the Medicaid program. The types of records that must be maintained are as follows: Medicaid claim forms, professional records such as patient treatment plans, prior and post authorization information, prescription records, business records, including accounting ledgers, financial statements, purchase and acquisition records etc., tax records, patient counseling information and provider enrollment documentation. Providers who are not in compliance with the Medicaid documentation and record retention policies described in the handbook are subject to administrative sanctions and/or recoupment of Medicaid payments. Medicaid payments for services that lack required documentation and/or appropriate signatures will be recouped. Chapter five of the handbook, in defining overpayment provides that any amount not authorized to be paid by the Medicaid program, whether paid as a result of inaccurate or improper cost reporting, improper claims, unacceptable practices, fraud, abuse or mistake, constitutes overpayment. Incomplete records are records that lack documentation that all requirements or conditions for the providing of services have been met. Medicaid may recoup payments for services or goods when the provider has incomplete records or cannot locate the records. The Agency contracted with Heritage to conduct an on- site audit at Brown. The audit was conducted March 18th through March 20, 2002. Heritage isolated a sample of 205 prescription claims, known as the "judgmental sample" out of a total universe of paid pharmacy claims from Brown totaling 16,727 for the audit period. Heritage also selected 250 random prescription claims out of the remaining total universe of paid pharmacy claims of 16,522, which remained after the 205 judgmental sample claims had been removed or isolated from the remainder of the total claims. With the acquiescence of the Agency, Heritage chose the 205 claims by weighing it in favor of the "high dollar" or more expensive drug prescriptions. Those prescriptions are primarily for HIV and Aids therapy drugs and psychotherapeutic drugs for various mental conditions, including schizophrenia. Weighing of the judgmental sample strongly in favor of the high dollar prescription claims would seem to render the judgmental sample fundamentally unfair against Brown if the judgmental sample had then been extrapolated to the entire universe of claims ($16,727). This was not done, however. The judgmental sample was audited and compiled by doing an actual count and totaling of claim amounts in dollars represented by all the discrepant prescriptions, including all those the Agency and Heritage maintained resulted in "overpayments" to Brown. Therefore, the judgmental sample is an actual number rather than an extrapolated calculation so that weighing the sample in favor of the high dollar prescriptions does not result in an unfair or biased sample, as to the judgmental sample. Because the judgmental sample was drawn from the total pool of audited claims and removed from that claim pool prior to the identification and drawing of the random sample, the two are mutually exclusive and the amounts calculated do not represent a duplication or overlap. Thus the findings from the judgmental sample and then the random sample may be properly added together. The randomly selected claims (random sample) were taken of the remaining 16,522 claims in the audit claim pool after the judgmental sample of 205 claims had been removed. According to the report rendered by Heritage, the 250 randomly selected claims totaled $10,632.59 in paid Medicaid dollars. The Heritage auditors determined that there were 56 discrepant claims out of these which totaled, according to their calculation, $2,450.13 in apparent overpayments. This resulted in an average overcharge per claim of $9.80 (determined by dividing the documented "sanction amount" by the total number of claims in the random sample (250), multiplied by the universe of claims from which the random sample was taken (16,522) which yielded an extrapolated overcharge of $161,924.19. Applying the statistically appropriate 95 percent "one-sided" lower confidence limit of this extrapolation resulted in a purported overpayment extrapolated from the randomly selected claims of $102,700.85. This means that the overpayment amount calculated by Heritage represents an amount statistically 95 percent certain to be the lowest amount overpayment based on the extrapolation of the overpayment represented in the 250 randomly selected claims. The non-extrapolated judgmental findings showed, according to Heritage, that there were 72 discrepant claims. Heritage then determined that, of these, there were $29,381.09 in apparent actual overcharges. The discrepancies determined by Heritage involved the failure to produce documentation of refill authorizations for 80 prescription claims; 31 prescription claims containing an incorrect Medicaid provider number; the failure to produce 12 "hard copy" prescriptions representing 25 claims; four claims that did not have the prescriber's DEA number on the prescription for controlled substances; three claims for prescriptions that did not contain the original date of service; two claims that were billed for quantities greater than that authorized by the physician; one claim that was billed for an incorrect day's supply; one claim that was billed in excess of the maximum allowable quantity of prescription of the drug, set by Medicaid policy; and one prescription claim that was billed for an incorrect prescriber's Medicaid provider number (although this should not be a discrepancy because the correct prescriber was documented in the pharmacy's computer, which the regulations allowed). Additionally, there was one claim billed for a drug different than that prescribed by the physician, according to Heritage in its report. Heritage also conducted an invoice review using utilization reports provided by the Respondent. This was apparently a review of 25 different drugs that purportedly showed that the prorated purchases of those drugs were insufficient to cover the number of units billed to Medicaid for all 25 drugs reviewed, and thus yielded a purported shortage of $87,942.13, representing the amount billed to Medicaid above the amount the records of purchases from suppliers proved that Brown had purchased of those drugs. Based upon the Heritage audit as well as documentation findings and overpayments calculations (see Exhibit 8), the Agency issued a PAAR dated September 27, 2002, determining that Brown had been overpaid $150,036.71 for Medicaid claims during the audit period. That report advised Brown that it was a provisional report only and encouraged Brown to submit any additional information or documentation which might serve to change the overpayment. The report listed examples of documentation that the Agency would consider for a possible reduction in the overpayment amount initially claimed. Thereafter, the Agency agreed to an extension of time for Brown to submit additional documentation and sent a letter to Brown dated October 31, 2003, advising that the audit had been placed in abeyance pending the outcome in a related case, but that the Agency expected to resume the audit and that therefore all Medicaid-related records and documentation regarding paid claims should be maintained and preserved until the audit was finalized. The FAAR was addressed in the testimony of Ms. Stewart for the Agency. Through her testimony it was revealed that certain corrections should be made to the FAAR updating it from the findings in the Heritage initial audit report. The Agency corrected the information in the FAAR for this reason and for the reason that it secured some additional information from the Respondent. Thus, for the audit period it was established that there were 16,727 total claims for prescriptions dispensed by Brown, for which it was paid $795,564.59 during the 21-month audit period, of those claims, 205 were pulled out from the total universe of claims as the judgmental sample. There were some 72 allegedly "discrepant claims" totaling $36,393.51 in dollars paid to Brown. The Agency's position is that $29,381.09 of those are so called "documented overcharges." The random sample of 250 claims was extrapolated to the remaining universe of 16,522 prescription claims. The Agency now takes the position that it found 49 "discrepant claims" in the random sample which totaled $2,154.40 in dollars paid to Brown's pharmacy and of that it maintains that $1,927.55 are "documented overcharges" for the 250 randomly selected claims (for which Brown had been paid $10,632.59). Thus the Agency found an average overcharge for the 250 randomly sampled claims of $7.71 per claim. The $7.71 average per claim overcharge was then multiplied by the remaining universe of 16,522 claims, yielding an extrapolated purported overcharge of $127,387.92. The Agency then applied the 95 percent "one-sided lower confidence limit" to this extrapolation, that is, that it or its statistician, Dr. Johnson, felt that there was a 95 percent chance that the lower confidence limit number it calculated was accurate. That number is $79,097.68. When that number is combined with the Agency's position as to overcharges from the judgmental sample results in a total postulated overcharge of $108,478.77. This is the final amount the Agency claims as an overpayment that must be recouped for Medicaid. The FAAR summarized the discrepant claims for the judgmental sample as follows: 61 claims involve refills which exceeded the authorized number of refills without documentation of reauthorization; 10 claims showed an incorrect prescriber license number but the correct prescriber license number was documented in the pharmacy's computer; and For two claims the hard copy description did not have an original date of service depicted on it and did not reference a DEA number. The discrepant claims shown in the FAAR as to the random sample were as follows: There were 19 claims for refills without documentation of refill authorization (refills had been previously authorized, but for the 19 claims at least one refill had been issued beyond the authorization limit); Fifteen claims showed an incorrect prescriber license number on the claim and the license number was not documented in the Respondent's computer; Seven claims showed an incorrect prescriber license number, but the correct license number was documented in the pharmacy's computer; There were seven claims for which the original hard copy prescriptions could not be found on file during the audit period; For one claim the hard copy prescription did not have an original date of service or DEA number; For one claim the quantity paid exceeded the quantity authorized by the prescriber or dispensed to the recipient; and For one claim the number of days supply submitted by the pharmacy was not consistent with the quantity and directions of the prescriber and the quantity exceeded the limit set by the plan. The most common discrepancies with regard to the judgmental sample and the random sample occurred when the Respondent billed refills in excess of the number authorized by the prescriber, without any written authorization for such being provided in the audit process or later. Concerning the random sample, the second most common discrepancy occurred when the claim depicted an incorrect precriber number on the claim and the license number of the prescriber was not documented in the computer. In the judgmental sample the second most common discrepancy occurred when the claim showed an incorrect prescriber number, but the correct prescriber number was documented in the pharmacy's computer. The discrepancies in the FAAR with the indication "UR", references "unauthorized refills." The records of the pharmacy showed that Brown issued refills of prescriptions to Medicaid recipients in excess of the presriber's limit depicted on the prescriptions but showed no written record of a telephonic or written authorization by the prescriber allowing the additional refill or refills. It is also true that as to some or even many of these the Respondent may have obtained verbal authorization, but failed to document that re- authorization. Medicaid policy, the statutory authority cited herein, and the PDSCLR Handbook provide that all verbal orders authorized by the prescriber of a prescription must be recorded either as a "hard copy" or noted in the pharmacy's computer in order to comply with the relevant law cited herein, for record- keeping and auditing purposes under Medicaid policy. The Agency's Statistical Methodology Mark E. Johnson, Ph.D., testified on behalf of the Petitioner. He was qualified as an expert witness in the area of statistical formulas, statistical methodology, and random sampling, including the random sample statistical methodology employed by the Agency in determining the overpayment amount. He is a professor of statistics at the University of Central Florida. Dr. Johnson reviewed the statistical methodology, numbers and calculations arrived at by the Agency and its extrapolation method of arriving at the overpayment amount. He also used his own independent analysis based upon a software package he commonly uses in the practice of his discipline in testing the methodology employed by the Agency and the random sample employed by the Agency and Heritage. The statistical formula employed by Dr. Johnson and the Agency is a standard one routinely used in Dr. Johnson's profession and statistical sampling. He established through his own testing of the methodology that the random sample was appropriate for Medicaid program integrity audits and determinations as employed in this case. The random sampling, according to Dr. Johnson, was employed because it would be time and cost prohibitive to examine individually each of 16,522 claims regarding overpayment issues. The random sampling methodology using 250 randomly chosen samples is a time and cost saving device and yet still presents a "plausible estimate" as established by Dr. Johnson. He established that for the universe of 16,522 claims which were subjected to the random sample and extrapolation statistical analysis and calculation, that such is a reasonable sample for purposes of this audit and that the 250 random samples employed by the Agency are indeed statistically appropriate random samples. His calculation of overpayment was at variance with the Agency's by 55 cents. He established that is not a significant difference since the 95 percent certainty limit of $79,097.68 for the random sample extrapolation analysis is so much lower than the estimate established at $108,478.22. Dr. Johnson established that the Agency had employed appropriate and valid statistical methods in its determination of the above-referenced overpayment amount based upon the random sample of paid claims. The expert testimony of Dr. Johnson, together with his written report in evidence, is credible and persuasive as to the validity of the random sampling of the claims during the audit period and as to the random sample portion of the analysis employed in arriving at the final overpayment calculation and numbers depicted in the FAAR. Dr. Johnson established the appropriateness of the statistical formula, including extrapolation, used to calculate the overpayment amount, the appropriateness of the sample size relative to the universe of claims, and the improbability that the overpayment amount is attributable to chance causes alone. Thus Dr. Johnson's testimony is accepted as credible and persuasive in establishing the validity of the Agency's method of overpayment calculation, and the overpayment calculation in conjunction with the statistical evidence in this record, except as modified by the findings below.1/ The Respondent's Position Gary Steinberg testified on behalf of the Respondent, Brown Pharmacy. He was accepted as an expert witness in the areas of Medicaid policy, audits and pharmacy practice, including Florida pharmacy practice. Mr. Steinberg acknowledged that Brown had not properly documented all claims that had been paid by the Medicaid program nor maintained all required records. He emphasized in his testimony, however, that Brown had not fraudulently billed the Medicaid program with claims for prescription medications that it had not actually dispensed to the patients or recipients. Rather, all medications involved in the subject prescription claims had actually been dispensed. There is no evidence or claim on the part of the Agency that Brown charged and collected more than the appropriate approved price for the prescriptions at issue. Through the explanation given in his testimony, Mr. Steinberg opined that although Brown was guilty of technical errors in record keeping and documentation as to the prescriptions involved in the subject claims, Brown had made substantial compliance with the Medicaid program requirements of the Medicaid provider agreement and the statutes and rules at issue and policies embodied in the subject handbook. He explained in his testimony that in the pharmacy practice setting in which Brown has operated, whereby it serves a large indigent population in an inner city environment, it is difficult to contact a prescriber at the time when a patient needs a critical prescription refilled in order to get a refill authorization. The prescriptions at issue mostly involve critical medications for HIV/Aids and psychotropic medications for severe mental conditions such as schizophrenia. The patients who need these critical medications (and there are very few patients, since most of the procedures involve filling and refilling for a small number of such recipients) are patients of clinics operated at the nearby university hospital (Shands). In these circumstances, where the patient literally needs the HIV/Aids medication refilled on an immediate basis, possibly even to prevent death, and the mental health patient critically needs a refill in order to prevent harm to the patient or harm to the members of the public if the patient goes without medication and "decompensates," the ethical thing for a pharmacist to do is to refill the prescription and seek authorization later. Mr. Steinberg established that it is often difficult to obtain authorization from the original prescriber since the medication were prescribed by residents practicing in the various clinics at the Shands Hospital and that the residents can not always be identified or contacted easily since they do not maintain a fixed medical practice in the area. Consequently, some of the prescriptions were not documented as to authorization, although in some cases the pharmacy actually obtained authorization and entered it in its computer. In some cases, being unable to obtain re-authorization from the resident who originally prescribed the medication the pharmacy used the DEA license or prescribing number of the hospital itself. He explained that although under the law a pharmacy can refill a prescription on an emergency basis for up to a 72-hour supply, that this is generally impracticable and unsafe for patients in this plight because such indigent, mental health and HIV/Aids patients tend to be non-compliant with their medication regimes quite often anyway, and it is often unreasonable to expect them to return to the pharmacy for another refill within two or three days. He thus opined that the ethical and safe thing for the pharmacist to do was to refill and re-dispense the medical approved medication for up to a 30 or 34-day supply (the normal refill supply duration). He further explained that the Shands Hospital license number was used in some of these circumstances because the resident doctor who originally issued the prescription could not be identified on the Shands Hospital prescription forms and because the resident doctors at the Shands clinics only have and can use Shands Hospital prescription forms in any event. Mr. Steinberg thus established that 35 percent of those prescription claims classified as "WMP," that is the prescription claims contained an incorrect prscriber license number were for these reasons and the pharmacist could only use the Shands Hospital license number because the resident could not be identified from the Shands Hospital prescription forms. He thus opined that 35 percent of the random sample extrapolation amount, the 95 percent statistical confidence limit amount of $79,097.00, should be deleted from that amount in determining the correct amount of overpayment predicated on the random sample. Likewise, with regard to the judgmental sample concerning the HIV/Aids and mental health patient prescriptions and related claims, he opined that, in effect, $19,500.00 of the total $29,381.09 overpayment amount claimed by the Agency pursuant to the judgmental sample portion of the claims, should be deleted from that portion of the overpayment claim by the Agency; this is a result of his explanation regarding "substantial compliance" in the critical refill situation he described concerning the HIV/Aids and mental health patients and their prescription drugs. The preponderant, persuasive evidence does establish (and indeed the Agency acknowledged in its Proposed Recommended Order) with regard to the judgmental sample, that 10 of the claims at issue listed an incorrect prescriber license number, but that the correct prescriber license number was actually documented in the pharmacy's computer record with the name of the prescriber. This circumstances comports with the law referenced below and in the Petitioner's Proposed Recommended Order. This results in a reduction in the overpayment claim with regard to the judgmental sample of 13.88 percent of the judgmental sample claims or a reduction of $4,078.09. Likewise, with regard to the random sample extrapolation calculation of overpaid claims, the preponderant, persuasive evidence, also as acknowledged by the Agency in its Proposed Recommended Order, disclosed that seven claims listed an incorrect prescriber license number on the claims, but had been correctly documented in the pharmacy's computer system and therefore were in compliance with the relevant statutes, rules, and the subject handbook. Thus the discrepant claims and the overpayment amount related to the random sample portion of the audit claims should be reduced by 14.28 percent of the total amount of $79,097.00 for a $11,295.05 reduction of that $79,097.00 random sample overpayment amount. Mr. Steinberg demonstrated that Brown was not overcharging on the drugs prescribed and dispensed and was charging the Medicaid-authorized amount for the drugs involved in the prescription claims at issue. The Agency is not claiming that there was any fraudulent practice or illegal overcharging for the prescriptions involved. In fact, Brown was earning only a very small profit on the drugs dispensed that are the subject of the prescription claims at issue. Mr. Steinberg thus opined that since Brown did indeed dispense all the drugs at issue and was only paid the legal authorized amounts for the drugs and prescriptions at issue that recoupment of the amounts sought by the Agency or, in effect, established in these findings of fact, would be fundamentally unfair. He and the Respondent contend, rather, that since Brown performed substantial compliance, but was guilty of technical non-compliance with the relevant rules, agreement, and Medicaid policy, that the Agency should impose a lesser fine instead of seeking recoupment. In summary, in view of the preponderant persuasive evidence establishing the above facts, it has been shown that the documentation and record-keeping, dispensing errors, and omissions in the manner found above, with regard to the prescription claims and types of claims addressed in the above findings of fact, occurred. If those deficiencies amount to violations of the authority cited and discussed below which justify recoupment, then the amount of overpayment established by the above findings of fact is $93,104.95.
Recommendation Having considered the foregoing findings of fact, conclusions of law, the evidence of record, the candor and demeanor of the witnesses, and the pleadings and arguments of the parties, it is, therefore, RECOMMENDED that a final order be entered by the Agency for Health Care Administration providing for recoupment of $93,104.95, and that the Respondent, Brown Pharmacy, must re-pay that amount to the Petitioner Agency, through a reasonable re- payment plan established between the parties. DONE AND ENTERED this 3rd day of November, 2006, in Tallahassee, Leon County, Florida. S P. MICHAEL RUFF Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with Clerk of the Division of Administrative Hearings this 3rd day of November, 2006.
The Issue This is a license discipline case, in which the Petitioner seeks to take disciplinary action against a pharmacy licensee on the basis of alleged violations of Sections 465.014, 465.023(1)(c), and 465.025(3)(b), Florida Statutes.
Findings Of Fact The Respondent in this case, Nan-Dan, Inc., is, and has been at all times material to the Second Amended Administrative Complaint, a licensed community pharmacy, holding license number PH 0002807. The Respondent does business as "Buy-Rite Drugs." The Respondent's address is 103 South 3rd Street, Lantana, Florida 33462-2853. The Respondent Nan-Dan, Inc., does not do business as "Professional Rx Systems." There is another business entity known as "Professional Rx Systems," which was licensed in November of 1987, and which does business as "Nan-Dan Corp., Inc." Professional Rx Systems is a licensed community pharmacy, having been issued license number PH 0010094. Professional Rx Systems is a separate and distinct licensee and is a separate and distinct business entity from Nan- Dan, Inc., the Respondent in this case. On or about May 30, 1991, a pharmacy (probably Professional Rx Systems) prepared a billing statement regarding prescriptions for patient O.I. The entries on the billing statement include an entry for prescription number 6171144, described as "60 ROBAXIN-750 TABS," with a corresponding charge of $33.42. The second page of the May 30, 1991, billing statement includes an entry for prescription number 4173954, described as "30 DARVOCET N 100," with a corresponding charge of $20.02. Robaxin 750 and Darvocet N-100 are both brand name drugs. Dr. Faustino Gonzalez was and is the Medical Director of Gold Star Medical Management, a company which subcontracts with Humana Medical Plans to provide medical services to a group of patients. The facilities at which Gold Star Medical Management provides medical services probably includes Eason Nursing Home. In any event, in approximately May of 1991, Gold Star Medical Management did a quality review for Eason Nursing Home, in which it looked at the prescriptions for numerous patients. Of the cases that were reviewed, Dr. Gonzalez did not recall seeing anything but generic drugs which had been actually dispensed to the patients. However, Dr. Gonzalez does not recall whether the Robaxin 750 listed on the billing statement described above was one of the drugs he reviewed. Similarly, there is no evidence that the Darvocet N- 100 listed on the billing statement described above was one of the drugs reviewed by Gold Star Medical Management. Dr. Gonzalez did not recall whether he had ever actually seen patient O.I. and he did not know whether the drugs actually furnished to patient O.I. were brand name drugs or generic drugs. There is no evidence in the record of this case of the identity of the pharmacist or pharmacists who may have dispensed any drugs to patient O.I. There is no evidence in the record of this case as to the amount of the cost savings, if any, that accrued or might have accrued to the pharmacy if generic drugs had been dispensed in lieu of brand name drugs. There is no evidence in the record of this case as to how much was paid by or on behalf of the patient O.I. for the drugs itemized on the billing statement described above. For a brief period during July of 1987, the Respondent employed Harold B. Steinberg as a pharmacist. Mr. Steinberg presently has a hostile attitude towards the owner of the Respondent corporation. From approximately February of 1991 through May of 1991, Joyce Trapp was employed by the Respondent as a pharmacy technician.
Recommendation On the basis of all of the foregoing, it is RECOMMENDED that the Board of Pharmacy enter a Final Order in this case dismissing all of the violations alleged in the Second Amended Administrative Complaint. DONE AND ENTERED this 25th day of August, 1993, at Tallahassee, Leon County, Florida. MICHAEL M. PARRISH Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 25th day of August, 1993. APPENDIX TO RECOMMENDED ORDER, CASE NO.92-4270 The following are my specific rulings on all proposed findings of fact submitted by all parties. Findings submitted by Petitioner: Paragraph 1: Rejected as contrary to the greater weight of the evidence. (See Petitioner's Exhibit 2.) Paragraph 2: Rejected as not supported by clear and convincing evidence. The only witness to testify on this matter only referred to Eason as one of the nuring homes "being taken care of by Mr. Erb's operation." Mr. Erb has two operations, only one of which is a respondent here. Further, the witness' lack of reliable information on the matter is revealed by his testimony that he ". . . never got to see the papers." As a final matter, the Hearing Officer has given very little credit to Mr. Steinberg's testimony. Mr. Steinberg's testimony was vague and imprecise and Mr. Steinberg appeared to have very hostile feelings towards the owner of the Respondent entity. Paragraph 3: Accepted. Paragraph 4: Rejected as not supported by persuasive clear and convincing evidence. Mr. Steinberg's testimony on this subject was vague and imprecise. It also has some unexplained conflicting details, among them the assertion at one point that Steinberg was the only pharmacist on the premises and the later assertion that Mr. Erb was present and that Mr. Erb was also a pharmacist. Further, the only evidence of the absence of supervision consists of hearsay evidence that would not be admissible over objection in a civil action, largely because the hearsay speakers are unidentified. And as a final matter, the activities vaguely described by Mr. Steinberg do not constitute "dispensing" within the statutory definition of the word "dispense" at Section 465.003(5), Florida Statutes (1986 Supp.). Paragraph 5: Rejected as irrelevant or as subordinate and unnecessary details. Paragraph 6: Accepted. Paragraph 7: Rejected as irrelevant because not charged in the Second Amended Administrative Complaint. Also rejected as not supported by persuasive clear and convincing evidence. Ms. Trapp appeared to have a very poor memory and her testimony tended to be vague and incomplete. Paragraph 8: Rejected for several reasons, including the fact that without a reference to the time and place of these proposed facts, there is no way to determine whether these proposed facts are relevant to the allegations of the Second Amended Administrative Complaint. Also rejected because there is no persuasive clear and convincing evidence of these proposed facts. Paragraphs 9, 10, 11 and 12: Accepted in substance. Paragraph 13: Rejected as either not supported by persuasive clear and convincing evidence or as being contrary to the greater weight of the evidence. In this regard it is noted that, although Petitioner's Ex. 3 is incomplete at the top, the visible portion of the business name at the top of the statement is "X SYSTEMS" and printed across the bottom of the statement is the business name "PROFESSIONAL RX SYSTEMS." Accordingly, it is more likely that the drugs billed to patient O.I. were billed by Professional Rx Systems (which is not a Respondent in this case) than that they were billed by the Respondent, Nan-Dan, Inc., d/b/a Buy Rite Drugs. Further, Dr. Gonzalez' testimony was to the effect that he was not sure whether his review included the drugs allegedly furnished to patient O.I. Paragraphs 14 and 15: Rejected as not supported by persuasive competent substantial evidence. As noted above, any dispensing involving the patient O.I. was probably done by someone other than the Respondent and, in any event, there is no persuasive competent substantial evidence as to what was actually dispensed. Paragraph 16: Accepted. Paragraph 17: Rejected as not supported by persuasive competent substantial evidence or as contrary to the greater weight of the evidence. (See discussion of Paragraphs 13, 14, and 15, above.) Paragraph 18: Accepted that the mentioned drug is a brand name "medicinal drug." The remainder of this paragraph is rejected as irrelevant, as well as not supported by persuasive competent substantial evidence. Paragraph 19: Rejected as not supported by persuasive competent substantial evidence. Findings submitted by Respondent: Paragraphs 1 and 2: Accepted. Paragraphs 3, 4, 5, and 6: Accepted in substance. Paragraph 7: Accepted. Paragraphs 8, 9, 10, 11, 12, and 13: Accepted in substance. Paragraphs 14 and 14: The last two paragraphs (both of which are numbered as 14) of the Respondent's proposed findings are, for the most part, rejected as constituting arguments as to why findings should not be made, rather than proposed findings of fact. (It is noted that the arguments are, essentially, correct and have been considered in deciding what findings should be made.) COPIES FURNISHED: Wayne H. Mitchell, Esquire Department of Business and Professional Regulation Northwood Centre, Suite 60 1940 North Monroe Street Tallahassee, Florida 32399-0792 William M. Furlow, Esquire Katz, Kutter, Haigler, Alderman, Davis & Marks, P.A. Post Office Box 1877 Tallahassee, Florida 32302-1877 Jack McRay, General Counsel Department of Business and Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792 John Taylor, Executive Director Board of Pharmacy 1940 North Monroe Street Tallahassee, Florida 32399-0775
The Issue Whether or not the Respondent's license to practice pharmacy should be suspended or revoked pursuant to Section 465.101(1)(e) and 893.13(3)(a) 1 , Florida Statutes. The Hearing Officer explained to the Respondent the nature of the hearing and his rights under the Administrative Procedure Act, including the right to be represented by counsel at his own expense, if he so desires. It was also explained to the Respondent that he could testify in his own behalf, but that he was not required to do so and that if he did so testify, he could be cross- examined by counsel for Petitioner. Respondent acknowledged understanding of these rights and elected not to testify in his own behalf during the course of the hearing; however, he did participate in the cross-examination of Petitioner's witnesses and made a closing statement in which he denied the allegations against him.
Findings Of Fact During the period in question, i.e., April, 1975, Mr. Stanley Margolis was the manager of Gray Drug Store, No. 365, located at 12852 Biscayne Boulevard, North Miami, Florida. He and the Respondent are the only licensed pharmacists employed at that store (testimony of Mr. Margolis). "Eskatrol" is a trade name for a drug which is bottled and sold in capsules called "spansules". It contains dextro- amphetaminesulfate and acts as a stimulant on the central nervous system. It is used primarily as an appetite suppressant, although it also is sometimes prescribed in an emergency situation for narcolepsy to keep a person awake. It is a Schedule II drug under the Florida Comprehensive Drug Abuse and Prevention Act, Chapter 893, F.S. because it is an amphetamine (Testimony of Mr. Bell, Dr. Danoff). The procedure employed by Gray Drug Store to order Schedule 11 drugs was for Mr. Margolis to write a narcotic order form which he sent to a wholesaler who would then fill the order and send back an invoice with the narcotics in a box that was signed for by one of the pharmacists. At that time, the drugs would be counted, checked off and written down. Either Margolis or Respondent was on duty at the drug store at all times when it was open for business and Respondent could sign for such deliveries if Margolis was not then present. On approximately April 10 or 11, the store had run out of narcotics order forms and had exhausted its supply of several drugs, including ones with the trade name of Eskatrol. However, on Saturday, April 12, a prior order for ten bottles of Eskatrol, each bottle containing 50 capsules or "spansules" as they were termed, were received at the store. Respondent was on duty at this time and signed for the shipment. It was his responsibility to check the numbers of bottles received, enter the amount in a narcotics journal and place the drugs in a locked cabinet. On Monday, April 14, Margolis came on duty, reviewed the receipt of Eskatrol and determined that the shipment was correct based upon his examination of the invoice. He did not check the drug cabinet at this time. About 6:00 or 7:00 p.m. he received a prescription for 50 sparsules of Eskatrol. At this time, he noticed that there were only eight bottles in the cabinet when there should have been ten. He thereupon checked his prescription files for narcotic and other drugs and found no prescription to cover the two missing bottles of Eskatrol ewhich would have contained a total of 100 spansules. The store maintained a daily prescription log which indicated the prescriptions filled and a "waiting" file which was used to hold prescriptions for emergency drugs which had been issued pursuant to a telephonic request of a physician while waiting for the written prescription from the physician to arrive at the store. Mr. Margolis, on the morning of April 16, asked Respondent about the discrepancy. The Respondent told him that the wholesaler had been" short two bottles." Margolis was disturbed about this alleged shortage and therefore called the district manager of Gray Drugs, a Mr. Krake. On the morning of April 17, Margolis found a telephoned prescription form for 50, spansules of Estatrol in the "waiting" file (Petitioner's Exhibit 1). The Respondent told him that it had been called in and that he was waiting for the prescription. He said that he had written the prescription. Margolis identified the handwriting as being that of the Respondent. The prescription was in the name of Ron Richards and showed an address of "2405 Northeast 135". It did not bear a street, avenue, or city designation. There was no date entered in the "Date" space on the form, but the figures "4/14" appeared on the "RX" portion of the form. This portion also bore the handwritten number 221030, and showed the figures "825". The doctor's name was Danoff and shown with address of 4100 South Hospital at Plantation. The number 5870448 also appeared on the prescription form and the words "will mail". Mr. Margolis then reviewed what had been entered on Sunday in the prescription log book and discovered that prescription number 221030 showed a patient named Kasen and a price of $1.95 for the prescription (Petitioner's Exhibit 2) . The practice of the pharmacy had been to use a numbering machine which would stamp the prescription and the patient's receipt with the prescription number. Although 99 percent of the prescriptions are marked with the numbered stamp, occasionally there can be some mistake if the machine jumps, and the same number can only be stamped two times by the machine. On April 14, while Mr. Margolis was checking the non-narcotic prescription files, he had seen a prescription numbered 221030 for 15 Actifed tablets, prescribed by a Dr. Wrench for a patient named Kasen. The retail price of 15 Actifed tablets is $1.95. His log book also reflected that the next number in sequence, prescription no. 221031, was also prescribed by Dr. Wrench for patient Kasen for Keflex (Petitioner's Exhibit 3). Both of these prescriptions were entered on the log for April 13th. Margolis does not know what happened to the other prescription bearing the number 221030; he saw it last on the night of April 15 (testimony of Mr. Margolis; Petitioner's Exhibits 1-3). Dr. Sherwood Danoff, a licensed physician who practices at Plantation, Florida, specializes in dermatology. He is not familiar with the name of Ron Richards and did not call the Gray Drug Store of North Miami, Florida, on April 13, 1975, to order Eskatrol for that individual. He had never written a prescription for Eskatrol, which is a combination of an amphetamine and a barbituate used in diet control as an appetite suppressant. He did not receive a phone call on April 13 from the Gray Drug Store and has never spoken on the phone to anyone representing himself to be the Respondent Mark Gorsky. The normal dosage of Eskatrol is one or two capsules a day and, although he has prescribed Schedule II drugs on an emergency basis over the phone, he would never issue a prescription for a dosage that would cover more than a 10-day period. An emergency prescription by telephone is usually given only for the period until the patient can get in to see the doctor. This is known as an oral prescription and the doctor must follow this up with a written prescription within 72 hours. Although Petitioner's Exhibit 1 reflects Dr. Danoff's phone number, he did not phone in the prescription (testimony of Dr. Danoff). On April 17, Mr. William W. Smith, the regional manager of Professional Services for Gray Drug Stores, Mr. Anthony Difulio, the Director of Loss Prevention for the drug Store chain for Florida, and Mr. Vernon K. Bell, an agent for the Florida Board of Pharmacy, met at the Gray Drug Store in North Miami to look into the discrepancy reported by Mr. Margolis. Mr. Smith made an inspection of the books and records of the store and discovered that certain narcotic drugs were missing, including two bottles of Eskatrol. He checked with Dr. Danoff's nurse and Gulf Company, the wholesaler of Eskatrol. He tried to find the address of Ron Richards, as shown on the prescription in an incomplete form, but any projection of the address by avenues or streets would place it in Biscayne Bay or the ocean. Mr. Smith, together with Mr. Difulio, Mr. Bell, and Mr. Krake, went into a back room of the drug store to discuss the situation and later asked the Respondent to join them. Neither Mr. Difulio nor Mr. Bell arc law enforcement officers and do not have the power to take a person into custody other than that effected under an ordinary citizen's powers. During this period, not all of the above-mentioned individuals remained in the room during the entire period of approximately an hour or an hour and a half. Mr. Gorsky left the room on two occasions. Prior to questioning the Respondent, Mr. Bell advised him that he did not have to answer any questions, that he had a right to remain silent and a right to counsel. He did not threaten him or offer him any inducements to answer questions. After this warning, Respondent decided not to take the polygraph or make a written statement, but he did make oral statements. At no time was Respondent told he was under arrest. Mr. Bell asked Respondent if he could explain or know anything about the shortage of Eskatrol. The Respondent stated that he had received a call from Dr. Danoff on Sunday, April 13, concerning the prescription and that he called the doctor back to make sure that it was authentic; that he had placed the `number at the right bottom of the prescription and in his mind it was legitimate. When asked about the existence of Ron Richards, Respondent told Bell that Richards had been in the store several times. Respondent admitted to Bell that he had written the prescription (Petitioner's Exhibit l) and that it was his handwriting. There is a certain conflict in what Respondent stated at this meeting in view of the fact that Mr. Difulio testified that Respondent had said a customer had come into the store on April 13 and said that a doctor wanted him to have Eskatrol; that he had called the doctor and verified the prescription. Difulio did not recall if Respondent had stated that he had first had a call from the doctor, although he testified that Respondent said that he had prepared the prescription and filled it for Richards. When shown by Difulio that the cash register tapes for April 13 did not reflect an entry of $8.25, and Respondent was asked for an explanation, he stated that he had probably "got taken" by believing the telephone number he called was that of the doctor. In addition, Respondent told Difulio that after filling the prescription, he became scared and put a number on it from another patient and, when asked by Difulio what had happened to it, Respondent stated that he had torn it up and destroyed it. Difulio did not recall Respondent telling Mr. Bell about Dr. Danoff calling Respondent concerning the prescription. However, Respondent made several different statements during the course of his interrogation while various of the parties to the meeting went in and out of the room (testimony of Mr. Smith, Mr. Difulio, Mr. Bell).
The Issue The issue in this case is whether Florida Administrative Code Rule 64B16-27.500(6) regarding the negative drug formulary is an invalid exercise of delegated legislative authority within the meaning of Subsection 120.52(8), Florida Statutes (2007).1
Findings Of Fact Levothyroxine Sodium is a drug used to treat Hypothyroidism and Pituitary TSH Suppression. Mylan develops, manufactures, and sells generic pharmaceuticals and is licensed as a non-resident prescription drug manufacturer and an out-of-state prescription drug wholesaler in Florida pursuant to Section 499.01, Florida Statutes. Mylan has received approval from the United States Food and Drug Administration (FDA) to market 12 strengths of generic Levothyroxine Sodium tablets, which the FDA has determined to be bioequivalent and therefore therapeutically equivalent to corresponding strengths of four reference listed drugs2: Unithorid® tablets, Synthroid® tablets, Levoxyl® tablets, and Levothroid® tablets. Abbott is the manufacturer of Synthroid®, a Levothyroxine Sodium product marketed in Florida and other places. The Board of Pharmacy “has authority to adopt rules pursuant to ss. 120.536(1) and 120.54 to implement the provisions of [Chapter 465] conferring duties upon it.” § 465.005, Fla. Stat. Subsection 465.025(6), Florida Statutes, provides: The Board of Pharmacy and the Board of Medicine shall establish by rule a formulary or generic drug type and brand name drug products which are determined by the boards to demonstrate clinically significant biological or therapeutic inequivalence and which, if substituted, would pose a threat to the health and safety of patients receiving prescription medication. Subsection 465.025(1)(a), Florida Statutes, defines “brand name” as “the registered trademark name given to a drug product by its manufacturer, labeler, or distributor.” “Generically equivalent drug product” is defined in Subsection 465.025(1)(b), Florida Statutes, as “a drug product with the same active ingredient, finished dosage form, and strength.” Subsection 465.025(2), Florida Statutes, provides: A pharmacist who receives a prescription for a brand name drug shall, unless requested otherwise by the purchaser, substitute a less expensive, generically equivalent drug product that is: Distributed by a business entity doing business, and subject to suit and service of legal process, in the United States; and Listed in the formulary of generic and brand name products as provided in subsection (5) for the brand name drug prescribed unless the prescriber writes the words “MEDICALLY NECESSARY,” in her or his own handwriting, on the face of a written prescription; unless, in the case of an oral prescription, the prescriber expressly indicates to the pharmacist that the brand name drug prescribed is medically necessary; or unless, in the case of a prescription that is electronically generated and transmitted, the prescriber makes an overt act when transmitting the prescription to indicate that the brand name drug prescribed is medically necessary. When done in conjunction with the electronic transmission of the prescription, the prescriber’s overt act indicates to the pharmacist that the brand name drug prescribed is medically necessary. Subsection 465.025(5), Florida Statutes, provides: Each community pharmacy shall establish a formulary of generic and brand name drug products which, if selected as the drug product of choice, would not pose a threat to the health and safety of patients receiving prescription medication. In compiling the list of generic and brand name drug products for inclusion in the formulary, the pharmacist shall rely on drug product research, testing, information, and formularies compiled by other pharmacies, by states, by the United States Department of Health, Education, and Welfare, by the United States Department of Health and Human Services, or by any other source which the pharmacist deems reliable. Each community pharmacy shall make such formulary available to the public, the Board of Pharmacy, or any physician requesting same. The formulary shall be revised following each addition, deletion, or modification of said formulary. If a brand name drug or a generic drug type drug product is listed on the negative drug formulary established by the Board of Pharmacy and Board of Medicine, a pharmacist is prohibited from substituting a generically equivalent drug product for a prescribed brand name drug product. § 465.025(6)(b), Fla. Stat. The Board of Pharmacy has adopted a negative drug formulary which is contained in Florida Administrative Code Rule 64B16-27.500, and Levothyroxine Sodium is listed on the negative drug formulary. Thus, Mylan’s generic products currently cannot be substituted where a prescription is written for a brand name Levothyroxine Sodium product. Mylan has challenged Florida Administrative Code Rule 64B16-27.500(6), which provides: The negative drug formulary is composed of medicinal drugs which have been specifically determined by the Board of Pharmacy and the Board of Medicine to demonstrate clinically significant biological or therapeutic inequivalence and which, if substituted, could produce adverse clinical effects, or could otherwise pose a threat to the health and safety of patients receiving such prescription medications. Except where certain dosage forms are included on the negative drug formulary as a class, all medicinal drugs are listed by their official United States Pharmacopoeia Non-Proprietary (generic) name. The generic name of a drug shall be applicable to and include all brand-name equivalents of such drug for which a prescriber may write a prescription. Substitution by a dispensing pharmacist on a prescription written for any brand name equivalent of a generic named drug product listed on the negative drug formulary or for a drug within the class of certain dosage forms as listed, is strictly prohibited. In cases where the prescription is written for a drug listed on the negative drug formulary but a name brand equivalent is not specified by the prescriber, the drug dispensed must be one obtained from a manufacturer or distributor holding an approved new drug application or abbreviated new drug application issued by the Food and Drug Administration, United States Department of Health and Welfare permitting that manufacturer or distributor to market those medicinal drugs or when the former is not applicable, those manufacturers or distributors supplying such medicinal drugs must show compliance with other applicable Federal Food and Drug Administration marketing requirements. The following are included on the negative drug formulary: * * * (6) Levothyroxine Sodium. Subsection 465.0251(1), Florida Statutes, provides: The Board of Pharmacy and the Board of Medicine shall remove any generic named drug product from the formulary established by s. 465.025(6), if every commercially marketed equivalent of that drug is “A” rated as therapeutically equivalent to a reference listed drug or is a reference listed drug as referred to in “Approved Drug Products with Therapeutic Equivalence Evaluations” (Orange Book) published by the United States Food and Drug Administration. The Orange Book identifies drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug, and Cosmetic Act. It also includes therapeutic equivalence evaluations for approved multisource prescription drug products. The Orange Book is updated annually and is supplemented with monthly cumulative updates. Additionally, the FDA has a website containing an electronic version of the Orange Book, which is also updated. The Orange Book used in 2007 is the 27th Edition. The Orange Book in effect at the date of the enactment of Section 465.0251, Florida Statutes,3 was the 21st Edition. Generally, approval by the FDA is required before a prescription drug product may be marketed, distributed, or sold in the United States. See 21 U.S.C. § 355(a). When a product contains a new active ingredient or otherwise differs significantly from previously approved products, the sponsor must provide the FDA with data demonstrating the product’s safety and effectiveness for the intended use. See, e.g., 21 U.S.C. § 355(b). When a product is a copy of a previously approved product—-what is commonly called a “generic” version of the original drug—-proof of safety and effectiveness is not required. Instead, the FDA requires a showing that, with regard to certain characteristics, the proposed generic product is essentially the same as the approved product it purports to copy, which is called the “reference listed drug.” See 21 U.S.C. § 355(j). The FDA’s previous finding that the reference listed drug is safe and effective is then imputed to the generic product. In general, the generic product must contain the same active ingredient in the same strength, and it must be in the same dosage form (e.g., tablet, capsule, solution) as the reference listed drug. See 21 U.S.C. § 355(j). Products that share these characteristics are considered “pharmaceutical equivalents” by the FDA. Orange Book, 27th Ed., at v-vi (Jan. 2007). Subsection 465.025(1)(b), Florida Statutes, uses the term “generically equivalent drug products” to describe such products. “Drug products are considered to be therapeutic equivalents only if they are pharmaceutical equivalents and if they can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.” Orange Book, 27th Ed. at vi. The FDA classifies as therapeutically equivalent those products that meet the following criteria: they are approved as safe and effective; they are pharmaceutical equivalents in that they (a) contain identical amounts of the same active drug ingredient in the same dosage form and same route of administration, and (b) meet compendial or other applicable standards of strength, quality, purity, and identity; (3) they are bioequivalent in that (a) they do not present a known or potential bioequivalence problem, and they meet an acceptable in vitro standard, or (b) if they do present such a known or potential problem, they are shown to meet an appropriate bioequivalence standard; (4) they are adequately labeled; (5) they are manufactured in compliance with Current Good Practice Manufacturing Practice regulations. Id. These criteria are essentially the same criteria that existed in 2001 as shown in the final staff analysis of HB69, which was passed and became Chapter 2001-146, Laws of Florida, now codified as Section 465.0251, Florida Statutes. Drug products that have been relied on as reference listed drugs are so identified in the Orange Book, and products that are therapeutically equivalent to each other are identified by a shared therapeutic equivalence evaluation code (TE code). These are primarily, but not exclusively, reference listed drugs and the generic drugs approved on the grounds of pharmaceutical equivalence and bioequivalence to those reference listed drugs. Generally, the FDA uses a two-letter TE code, with a code of “AB” given to solid oral dosage form products that have demonstrated therapeutic equivalence. Orange Book, 27th Ed. at xii-xiii. For the vast majority of most multi-source drugs, there is one product that is the reference listed drug and one or more generic versions of that product, and all the products share a TE code of AB. However, there are situations in which there is more than one reference listed drug. These situations are discussed in the Orange Book, 27th Ed. at xiv. In certain instance, a number is added to the end of the AB code to make a three character code ( i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against. . . . Drugs coded as AB under a heading are considered therapeutically equivalent only to other drugs coded as AB under that heading. Drugs coded with a three-character code under a heading are considered therapeutically equivalent only to other drugs coded with the same three- character code under that heading. The FDA first officially described the three-character code rating system in the 16th edition of the Orange Book in 1996. Levothyroxine Sodium tablets are a drug product for which there are multiple reference listed drugs. Currently the Orange Book identifies seven Levothyroxine Sodium products approved for sale in the United States: Synthroid®, Levo-T®, Levoxyl®, Levothroid®, Unithroid®, a generic-named product manufactured by Genpharm, and a generic manufactured by Mylan. The current Orange Book also contains the following levothyroxine sodium products in a section identifying “Discontinued” products that, although approved for distribution in the United States, are not being marketed: Novothyrox, Levolet, and Tirosint. The following drug products are currently identified in the Orange Book as reference listed drugs: Synthroid®, Levo-T®, Levoxyl®, Levothroid®, and Unithroid®. In the case of Levothyroxine Sodium products, not all the reference listed drugs are considered therapeutically equivalent to one another. The Orange Book discusses this situation and explains the therapeutic evaluations for Levothyroxine Sodium products as follows: Because there are multiple reference listed drugs of levothyroxine sodium tablets and some reference listed drugs’ sponsors have conducted studies to establish their drugs’ therapeutic equivalence to other reference listed drugs, FDA has determined that its usual practice of assigning two or three character TE codes may be potentially confusing and inadequate for these drug products. Accordingly, FDA provides the following explanation and chart of therapeutic equivalence evaluations for levothyroxine sodium products. Levothyroxine Sodium (Mylan ANDA 76187) tablets have been determined to be therapeutically equivalent to corresponding strengths of Unithroid (Jerome Stevens NDA 021210) tablets. Levo-T (Alara NDA 021342), Levothyroxine Sodium (Mylan ANDA 76187), Unithroid (Jerome Stevens NDA 021210) and Levothyroxine Sodium (Genpharm ANDA 76752) tablets have been determined to be therapeutically equivalent to corresponding strengths of Synthroid (Abbott NDA 021402) tablets. Levo-T (Alara NDA 021342), Unithroid (Jerome Stevens NDA 021210), Levothyroxine Sodium (Mylan ANDA 076187) and Levothyroxine Sodium (Genpharm ANDA 76752) tablets have been determined to be therapeutically equivalent to corresponding strengths of Levoxyl (King/Jones Pharma NDA 021301) tablets. Levothyroxine Sodium (Mylan ANDA 76187) tablets have been determined to be therapeutically equivalent to corresponding strengths of Levothroid (Lloyd NDA 021116) tablets. Novothyrox (Genpharm NDA 021292) requires further investigation and review to establish therapeutic equivalence to corresponding strengths of any other Levothyroxine Sodium drug products and is rated BX. Levolet (Vintage NDA 021137) requires further investigation and review to establish therapeutic equivalence to corresponding strengths of any other Levothyroxine Sodium drug products and is rated BX. The chart outlines TE codes for all 0.025mg products with other products being similar. Therapeutic equivalence has been established between products that have the same AB+number TE code. More than one TE code may apply to some products. One common TE code indicates therapeutic equivalence between products. Trade Name Applicant Potency TE CODE Appl No Product No UNITHROID STEVENS J 0.025mg AB1 21210 001 LEVOTHYROXINE SODIUM MYLAN 0.025mg AB1 76187 001 LEVOXYL JONES PHARMA 0.025mg AB1 21301 001 SYNTHROID ABBOTT 0.025mg AB1 21402 001 SYNTHROID ABBOTT 0.025mg AB2 21402 001 LEVOTHYROXINE SODIUM MYLAN 0.025mg AB2 76187 001 LEVO-T ALARA PHARM 0.025mg AB2 21342 001 UNITHROID STEVENS J 0.025mg AB2 21210 001 LEVOTHYROXINE SODIUM GENPHARM 0.025mg AB2 76752 001 LEVOXYL JONES PHARMA 0.025mg AB3 21301 001 LEVO-T ALARA PHARM 0.025mg AB3 21342 001 UNITHROID STEVENS J 0.025mg AB3 21210 001 LEVOTHYROXINE SODIUM MYLAN 0.025mg AB3 76187 001 LEVOTHYROXINE SODIUM GENPHARM 0.025mg AB3 76752 001 LEVOTHROID LLOYD 0.025mg AB4 21116 001 LEVOTHYROXINE SODIUM MYLAN 0.025mg AB4 76187 001 NOVOTHYROX GENPHARM 0.025mg BX 21292 001 LEVOLET VINTAGE PHARMS 0.025mg BX 21137 001 Orange Book, 27th Ed. at xix-xx. In the Orange Book, 21st Ed. (Cumulative Supplement 6, June 2001), only two Levothyroxine Sodium tablet products were listed, Levoxyl® and Unithroid®, and both were rated as BX, meaning that the data that had been reviewed by FDA was insufficient to determine therapeutic equivalence. There were also 12 additional Levothryroxine Sodium products that were being commercially marketed in the United States and were not listed in the Orange Book.
The Issue At issue is whether Respondent committed the offenses set forth in the Administrative Complaint dated March 3, 2000, and, if so, what penalty should be imposed.
Findings Of Fact Respondent, Robert Gibson McLester, III ("McLester") is a licensed pharmacist 2 with a heretofore unblemished record. McLester graduated from the University of Florida with a degree in pharmacy in August 1977. He was licensed by the State of Florida to practice pharmacy in February 1978. He currently holds an Alabama pharmacy license, and was previously licensed in Mississippi but at some point ceased to pay the state's licensing fee; the license thus lapsed by operation of law. McLester received a Master of Science degree in hospital pharmacy from the University of Mississippi in December 1987 and a Master of Health Care Administration from the same institution the following May. McLester entered the Navy as an aviator cadet in June 1965, and was commissioned as a naval aviator in February 1967. He flew 103 missions with Attack Squadron 147 and was honorably discharged as a lieutenant in December 1970. Following a brief stint in the insurance and investment business, McLester applied unsuccessfully to medical school. McLester entered the University of Florida's pharmacy school in September 1974 and following his graduation in August 1977, has been continuously employed as a pharmacist when not pursuing advanced degrees in pharmacy and related fields. Much of McLester's pharmacy employment has been in the Navy, which he reentered in February 1978 as an ensign in the Medical Service Corps. McLester served in a variety of posts before retiring as a lieutenant commander in August 1992, including at the National Naval Medical Center in Bethesda, Maryland, where he supervised in excess of 25 pharmacists and pharmacy technicians in the preparation of an average of 1600 outpatient prescriptions per day. McLester continued the practice of pharmacy as a civilian, working briefly as a relief pharmacist for the Eckerd Drug chain in the Vero Beach area before being hired full time by Winn-Dixie in August 1992. Under McLester's supervision, Store No. 2358 enjoyed high sales volume and was used as a training site for other Winn-Dixie pharmacies. At all times during McLester's employment at Winn- Dixie, reports of annual inspections of his pharmacy conducted by the Agency for Health Care Administration ("AHCA") pursuant to law showed no deficiencies of any kind. McLester worked at the Winn-Dixie Store No. 2358 until June 17, 1998. McLester's separation from Winn-Dixie was voluntary. McLester left Winn-Dixie because he considered the hours assigned to him by his new supervisor, Steve Howard ("Howard") to be "slave hours." Following McLester's departure, sales and customer satisfaction at Store No. 2358 deteriorated. For most of the time relevant to this case, McLester was responsible for filling in the neighborhood of 150 prescriptions per day. That number placed his store at the high end of Winn- Dixie pharmacy productivity. 3 During the course of his employment at Winn-Dixie, McLester had occasion to report approximately a dozen instances of prescription drug fraud to the authorities, including St.Lucie County Detective Scott Silverman (Silverman). Following his resignation from Winn-Dixie, McLester worked briefly with various services which would find him work as a relief pharmacist. On the instructions of Howard, McLester was not permitted to work at any of the Winn-Dixie stores in the area. In October 1998, McLester found full-time employment with Doctors' Clinic Pharmacy in Vero Beach, a "closed pharmacy" which serves only the patients of that multi-specialty practice. During his term of employment at Winn-Dixie, McLester was assisted by about a half dozen pharmacy technicians. Pharmacy technicians are licensed by the state and must work under the close supervision of a registered pharmacist. Tasks which the law permits to be delegated to pharmacy technicians and which, in fact, are typically delegated to a pharmacy technician include ordering drugs, including controlled substances; receiving drugs and other inventory; counting and transferring drugs from their original containers to packages for individual prescriptions; shelf maintenance; department maintenance; and stocking shelves. Other tasks which pharmacy technicians may legally perform, and which were in fact performed by technicians at Winn-Dixie stores, include logging invoices into the computer system for payment; verifying orders shipped into the store; answering telephones; taking refills from patients or doctors provided that there is no change in any element of the prescription (i.e. instructions to the patient, dosage, etc.); requests to doctors to issue new prescriptions on behalf of a patient; preparing labels and delivering filled prescriptions to the pharmacist for final verification. Because of the nature of the tasks delegated to pharmacy technicians, the relationship between pharmacist and technician must be one of, as several witnesses testified, implicit trust. McLester trusted all of the pharmacy technicians with whom he worked at Winn-Dixie. One of the Winn-Dixie pharmacy technicians, Tonya Tipton ("Tipton") betrayed McLester's trust, along with the trust of the State of Florida which licensed her, Winn-Dixie which employed her, and several other pharmacists under whose supervision she worked. Weeks after McLester left Winn-Dixie, Tipton's betrayal of trust was discovered. Soon after, she was fired from Winn-Dixie and subsequently arrested for crimes she allegedly committed in and against the Winn-Dixie pharmacy. Tipton's arrest set in motion a chain of events which led to this Administrative Complaint. Following a work-related injury suffered in the early 1990s, Tipton developed a dependence upon prescription painkilling medication, including the narcotic nasal spray Stadol.4 Unbeknownst to anyone, Tipton devised a scheme by which she could steal Stadol from Winn-Dixie, and also obtain Stadol under a forged prescription. At all times prior to Tipton's firing from Winn-Dixie, she was a trusted employee. Tipton fell under suspicion when she stated to a co- worker that a package would be arriving the following day and that it should not be opened. Store employees opened the package nevertheless and discovered it contained Stadol. Thereafter, a fellow pharmacy technician followed Tipton into the ladies' room and discovered empty bottles of Stadol in the wastebasket. Confronted by store employees about her inappropriate instruction to the co-worker not to open the package, as well as the empty Stadol containers in the ladies' room, Tipton admitted only to taking one bottle of Stadol from the Winn-Dixie pharmacy. Abundant circumstantial evidence suggests that Tipton's dependence upon Stadol led her to commit more than the one offense to which she admitted. McLester had been the primary pharmacist on duty at Store No. 2358 during many of the shifts when Tipton was alleged to have illegally obtained Stadol. Following a criminal investigation by Detective Silverman and the arrest of Tipton, McLester's former supervisor, Howard, lodged a complaint against McLester with the Board of Pharmacy. In his letter of complaint, Howard characterized his complaint as an effort to protect the interests of Winn-Dixie "in case this problem was found out." Howard claimed that Mostafa Macida ("Macida"), who had replaced McLester as the store's primary pharmacist,"discovered" that Stadol was being stolen from the pharmacy but this testimony is rejected as inconsistent with the testimony of numerous individuals who, unlike Howard, had personal knowledge of the events surrounding Tipton's arrest. Macida suspected nothing and discovered nothing. Tipton's employment at Winn-Dixie began in February 1995 when she was hired as a pharmacy technician by McLester.5 In that capacity, Tipton worked not only with McLester, but also with then-Head Technician Ava Forsythe (Forsythe). Forsythe trained Tipton in the technicians' duties, including the various methods by which prescription drugs, both controlled and non-controlled, may be ordered. At all times relevant to this case, there are three ways in which Winn-Dixie pharmacies may procure drugs and medical supplies requiring prescriptions for resale to the public. The primary system is a computer-generated daily order. The system was referred to by many witnesses as "the PDX system" ("PDX"). Technicians, working under the supervision of the pharmacist, would review the order to verify that the required types and quantities of supplies were being ordered. When the order was deemed complete, "the button was pushed" and the order electronically transmitted to Winn-Dixie's major drug supplier, Bindley-Western.6 In theory, the computer would accurately track stock in over 2,000 line items. The computer was supposed to automatically add to the inventory based upon what was ordered, and subtract based upon records of what was actually dispensed to customers. In reality, the computer-generated inventory was corrupt on a daily basis. Because of the PDX system's unreliability, technicians often had to make adjustments by hand so that the computerized records would match what was actually in stock. Orders could also be manually keypunched into a unit called a Telxon, which also transmitted orders to Bindley- Western. The Telxon unit is portable. The size of a telephone, the Telxon unit at Store No. 2358 was generally kept in a drawer when not being used. Finally, drugs can be ordered from Bindley-Western and/or from one of two secondary suppliers used by Winn-Dixie from any telephone, whether or not the telephone is located in a Winn-Dixie store. None of the systems used by Winn-Dixie, either singly or in combination, had the ability to flag the fact that hundreds of bottles of Stadol had been ordered and paid for by Winn-Dixie, yet not placed on the shelves as pharmacy inventory in Store No. 2358, during the period of Tipton's employment. Under Winn-Dixie's system, it is possible for a pharmacy technician to order medications unbeknownst to the pharmacist, to have them paid for by Winn-Dixie, and to physically divert them to his possession before the medications were logged in to pharmacy inventory. Once drugs are properly entered into inventory, it is reasonable to expect that the pharmacist could be aware of large amounts of a drug being stolen from the inventory. Any single incident of placing unauthorized drug orders could take place in the two or three minutes the duty pharmacist might be absent to go to the restroom, or have his attention diverted for any reason. Silverman is an experienced police officer, having served for over two decades in various law enforcement positions in Florida. For nearly five years Silverman has been exclusively assigned to work with pharmacies and other law enforcement agencies in St. Lucie County. Silverman's job is to assist in the prevention and prosecution of crimes involving the misuse of prescription drugs. Silverman's involvement in this case began when Tipton sought him out. Tipton knew Silverman because her husband is a fellow St. Lucie County detective, and Tipton herself was a sworn St. Lucie officer. Tipton approached Silverman to confess that she had taken a bottle of Stadol from the Winn-Dixie store where she worked. Tipton's confession was not provoked by an attack of conscience. Rather, after she was fired by Winn-Dixie, she began damage control. As Silverman's investigation progressed, substantial effort was made to determine how Tipton had diverted Stadol and what, if any, other crimes may have been committed. Documents collected in the course of the investigation revealed that Tipton had developed a dependency on prescription painkillers dating to a back injury in 1990 in which she suffered a herniated disc. Tipton developed a dependency on Stadol in 1996, after dealing with pain related to the 1990 injury. Tipton claimed to Winn-Dixie security supervisor Robert Blakely ("Blakely") that she had told McLester of the problem, and that he referred her to her doctor for help. Ultimately, Silverman arrested Tipton on 17 counts of insurance fraud and one count of felony possession of a controlled substance. No evidence was offered regarding the disposition of Tipton's case. No evidence was presented of what, if any, effort was made to determine from Tipton if McLester had any complicity in her crimes. It was clear to Silverman that while Tipton had figured out a way to illegally divert Stadol to her unauthorized use, as of the date of the final hearing, "nobody knows how it was done." 7 There was conflicting testimony as to precisely how much Stadol was diverted by Tipton over the relevant period of time but Tipton's ability to obtain the drug through the use of fraudulent prescriptions and outright theft was audacious in scale. Stadol was a legend drug until June 1997 when the Drug Enforcement Agency upgraded its status to a Schedule IV controlled substance. Prior to October 19, 1996, Tipton had a legitimate prescription for Stadol. On that date, Les Gessley ("Gessley"), a relief pharmacist at Store No. 2358, approved a new Stadol prescription for Tipton under a legend number. Tipton used this approved prescription number subsequently when she herself prepared numerous unauthorized refills under this same number. Each of these unauthorized refills was listed on daily pharmacy logs certified mostly by McLester, but also by other duty pharmacists as well. Because these unauthorized prescriptions were refills rather than original prescriptions, the duty pharmacist was not required to personally view the original written prescription. McLester was the pharmacist on duty a majority of the days on which Tipton is believed to have diverted Stadol illegally. Somewhere between ten and twenty percent of the Stadol believed to have been unlawfully diverted by Tipton from Store No. 2358 was diverted after McLester had ceased to be employed there. Some of the Stadol obtained by Tipton under fraudulent prescription at Store No. 2358 was obtained on days when McLester was not the pharmacist on duty. In addition to Les Gessley and Mostafa Macida, other pharmacists on duty while Tipton was believed to have engaged in the criminal diversion of Stadol are Ted Kline and Al Leota. McLester admitted knowing Tipton had a problem with Stadol but did not know the extent of her problem. Forsythe told McLester that she thought there might be some Stadol missing from the shelves. When she shared her concern with McLester, he instructed Forsythe not to leave Tipton alone in the pharmacy. No evidence placed McLester's conversation[s] with Tipton and other parties about her use of Stadol in the context of when Tipton's alleged diversions occurred. According to Forsythe's unrebutted testimony, If you were that desperate you could order any medication you wanted on the Telxon machine or verbally order without knowledge of the pharmacist knowing what you were doing. And then when the medication comes in, you pay the invoice. You throw the invoice away. You throw the copy that you received from the computer away. The invoice is paid. The only person that will know about it will be the person at the headquarters that pays the payment on the invoice without knowing what is on it and the person gets the medication. Take the medication home via however and no one is the wiser. Winn-Dixie has no security procedures in place, such as searching handbags or packages, to prevent employee theft in the pharmacy. Winn-Dixie's ordering system is tailor-made to be abused by individuals who are, in Forsythe's words, "that desperate." It is not illegal for pharmacy technicians to fill their own prescriptions. It is possible for a pharmacy technician to fill or refill a prescription without the pharmacist knowing that had been done if he was absent from the pharmacy or had his attention diverted in some fashion. It appears that Tipton refilled her own fraudulent prescription on a number of occasions, but that her preferred method of diverting Stadol was outright theft. The Winn-Dixie system by which the pharmacies are stocked is flawed in a manner which allowed Tipton to divert Stadol without being detected by the duty pharmacist. The Department failed to show that McLester knew or should have known that Tipton had diverted Stadol to her unauthorized use at Store No. 2358.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the charges in the Administrative Complaint be dismissed. DONE AND ENTERED this 17th day of November, 2000, in Tallahassee, Leon County, Florida. FLORENCE SNYDER RIVAS Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 17th day of November, 2000.
Findings Of Fact At all times relevant hereto, respondent, Cuca Pharmacy, Inc. (Cuca), held community pharmacy license number PH007348 issued by petitioner, Department of Professional Regulation Board of Pharmacy. When the events herein occurred, Hortensia Lopez-Perez was its president and permittee. Its location is 11048 West Flagler Street, Miami, Florida. After the events herein occurred, the pharmacy was closed by emergency suspension order and it has remained closed since that time. In February, 1984 special agent Alberto Fernandez was performing undercover operations in the Miami area for the Drug Enforcement Agency (DEA) for the purpose of enforcing federal narcotic laws. On February 17, he received information from an informant that ten kilograms of cocaine could be purchased for $21,000.00 per kilogram from two individuals named Zayas and Santos. He was told the cocaine was stored at respondent's pharmacy. Fernandez met the two "dealers" in Hialeah but Zayas and Santos were unable to produce any drugs. Consequently, no sale took place. On February 25, Fernandez again received a telephone call from his informant and was told to go to Cuca and meet an individual named Jesus Avila who was interested in selling some cocaine. Fernandez, Avila and the informant met in the rear of the pharmacy where Avila agreed to sell ten kilograms of cocaine to Fernandez for an undisclosed price. They further agreed to meet in a nearby shopping center where Fernandez would show his money and Avila would show the drugs as a good faith gesture. If both parties were satisfied, they agreed to then make the transfer at Cuca. Fernandez went to the shopping center but when Avila did not appear at the designated time, Fernandez returned to Cuca. Respondent's permittee, Hortensia Perez, advised him the drugs were on the way and not to worry. Later on that day, Fernandez received a telephone call from his informant advising that two kilograms had just arrived at Cuca and to return there for the buy. When he returned he met Avila and Lopez-Perez and went to the back of the store. Avila told Fernandez he couldn't sell cocaine that day but could arrange to do so in a few days. On February 29, Fernandez received another telephone call from his informant who advised him that the cocaine was at Cuca and to be there at 3:00 p.m. At the designated time, Fernandez, the informant and Lopez-Perez went to the rear of the pharmacy where Lopez-Perez pulled a clear plastic bag containing a white powdery substance from a metal cabinet and gave it to Fernandez. The transfer of the substance was made without a prescription. Lopez-Perez was then arrested for allegedly violating federal narcotic laws. The contents of the bag were later subjected to a chemical analysis and found to weigh 2.2 pounds (one kilogram) and to be 95 percent pure cocaine hydrochloride, a controlled substance and legend drug which requires a prescription for dispensing. Records of Miami area drug wholesalers introduced into evidence reflected that Cuca had not ordered any cocaine for prescription purposes between 1982 and June, 1984. This was confirmed by testimony from Cuca's prescription department manager. Lopez was charged with one count of conspiring to possess with intent to distribute a controlled substance (cocaine) in violation of Title 21, U.S.C., Section 846, and with one count of possessing with intent to distribute a controlled substance (cocaine) in violation of Title 21, U.S.C., Section 841(a)(1) and Title 18, U.S.C., Section 2. She was found guilty on both counts, and a certified copy of the judgment and probation/commitment order dated August 16, 1984 was received in evidence. That document reflects she was sentenced to five years confinement and three years of special parole on count two and five years probation on the first count. Lopez is free on bond while she appeals that judgment.
Recommendation Based on the foregoing findings of fact and conclusions of law, it is RECOMMENDED that respondent be found guilty as charged in the first and second administrative complaints and that its license as a community pharmacy be REVOKED. DONE and ORDERED this 13th day of January 1986, in Tallahassee, Florida. DONALD R. ALEXANDER 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 13th day of January, 1986.
