Findings Of Fact Respondent Dora Villanueva, is a licensed pharmacist, having been issued license number PS 0014957, and whose last known address is 3017 Southwest 107the Avenue, Miami, Florida 33165. At all times material hereto, Respondent Villanueva was the prescription department manager and part-owner of Century Pharmacy, 3017 Southwest 107th Avenue, Miami, Florida 33165. Respondent Century is permitted to operate a community pharmacy under the laws of the State of Florida, having been issued permit number PH 0006839 and operating at 3017 Southwest 107th Avenue, Miami, Florida 33165. On or about August 5, 1983, a Department of Professional Regulation investigator purchased 20 Librax and 20 Donnatal from Century Pharmacy, without first presenting a prescription. The aforementioned Librax and Donnatal were dispensed by Jose Ceferino Calvera, not a licensed pharmacist in the State of Florida. Librax and Donnatal are medicinal drugs as defined in Subsection 465.003(7), Florida Statutes (1983)(F.S.), and require a prescription to be dispensed. Respondent Dora Villanueva was not present in the pharmacy when the Librax and Donnatal were dispensed on August 5, 1983, and the prescription department of the pharmacy had a sign stating that the prescription department was closed. On or about August 17, 1983, a Department of Professional Regulation investigator purchased ten Dalmane, 20 Librax and 20 Donnatal, from Respondent Villanueva at the Respondent Century Pharmacy, Inc. without first furnishing a prescription. Dalmane, Librax and Donnatal are medicinal drugs as defined in Section 465.003(7), F.S. and require a prescription to be dispensed. On or about August 22, 1983, a Department of Professional Regulation investigator purchased ten Tranxene 7.5 mg and ten Dalmane, 30 mg, from Respondent Villanueva at the Respondent Century Pharmacy, Inc., without a prescription. Tranxene and Dalame are medicinal drugs as defined in Section 465.003(7), F.S., and require a prescription to be dispensed. On or about September 8, 1983, an audit was conducted of the controlled substances at Respondent Century Pharmacy, Inc., for the time period of January 1, 1983 through September 8, 1983. Said audit revealed the following shortages in the drugs which were audited: DRUG SHORTAGE Dalmane 30 mg 1,590 Dalmane 15 mg 799 Ativan 1 mg 151 Ativan 2 mg 4,163 Talwin Injectable 22 Dalmane, Ativan and Talwin are controlled substances as defined in Chapter 893, F.S. and are medicinal drugs as defined in Subsection 465.003(7), F.S. Respondent Villanueva denied making the August 17, 1983 sale. However, she did remember Petitioner's investigator from the August 22, 1983, transaction. Since Petititoner's investigator kept a contemporaneous record of her purchases, Respondent's denial is rejected as not credible. Both Respondent Villanueva and Petitioners investigator are immigrants from Cuba. Respondents claim the investigator was allowed to make the August 22, 1983 purchase without a prescription because she stated she had recently arrived from Cuba and had no doctor or money to pay one. Even if this were an accurate account of the transaction (which Petitioner denies) it would not provide grounds for dispensing controlled drugs without a prescription.
Recommendation Based on the foregoing, it is RECOMMENDED: That Petitioner issue a final order suspending the license of Respondent Dora Villanueva and the permit of Century Pharmacy, Inc. for a period of 90 days. DONE and ENTERED this 31st day of July, 1984 in Tallahassee, Florida. R. T. CARPENTER, Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 31st day of July, 1984. COPIES FURNISHED: Bruce D. Lamb, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Blas E. Padrino, Esquire 2355 Salzedo Street, Suite 309 Coral Gables, Florida 33134 Wanda Willis, Executive Director Board of Pharmacy 130 North Monroe Street Tallahassee, Florida 32301 Fred M. Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 =================================================================
Findings Of Fact At all times relevant hereto, Eric A. Baum was a licensed physician in the State of Florida having been issued License No. ME 0027880. He is board certified as a psychiatrist and board eligible in internal medicine (Exhibit 3). Respondent has never established an active practice in Florida, although in the latter part of 1985 he maintained an office at his residence and later, for approximately 2 months, in a downtown office building in Sarasota. Between August 19, 1985 and December 30, 1985, Respondent prescribed Bentyl, Ritalin, Fiorinal, Cylert, Urecholine and Laradopa to "Terri Leigh", generally in quantities of 100 for Ritalin (10 mg.) and Fiorinal (Tab). During this period, 1250 10 mg. of Ritalin and 1550 tabs of Fiorinal were prescribed (Exhibit 14). Terri Leigh is an alias used by Respondent for his wife, Terri Baum (Exhibit 7). Ritalin is a Class II controlled substance, Fiorinal is a Class III controlled substance and Cylert is a Class IV controlled substance. During part of this time until delivery on October 21, 1985, Terri Baum was pregnant. Medical records prepared by Respondent for Terri Baum would indicate the medication was prescribed for headaches and depression. Both Ritalin and Fiorinal are contraindicated during pregnancy. Between July 30, 1985 and December 30, 1985, Respondent wrote prescriptions for "Pam Leigh" for 200 Fiorinal, 600 Cylert (37.5 mg.) and 500 Ritalin (10 mg.), (Exhibit 10). Pam Leigh is an alias for Respondent's then 16 year old daughter, Pam Baum. Respondent contends that Pam is hyperkinetic and suffered from migraine headaches, and the medication was prescribed for those diagnoses. However, Pam denies ever taking any drugs or having any illness requiring such medication. Mark Baum, Pam's twin brother, denies that Pam is or was hyperkinetic or that he ever saw her take any medication. This latter evidence is deemed to be more credible than Respondent's testimony (Exhibit 3). The quantity of controlled substances prescribed for Terri and Pam by Respondent during the periods above-noted are greater than should be prescribed for the symptoms noted and were inappropriate. On April 15, 1987, Respondent pleaded nolo contendere to the offense of obtaining drugs by fraud in the Circuit Court of Sarasota County, Florida, adjudication of guilt was withheld, and he was placed on probation for one year with certain terms (Exhibit 11). At the time Respondent's residence (and office) were searched by police pursuant to a search warrant seeking patient's records for Terri and Pam Baum, those records could not be found, and Respondent denied knowledge of their whereabouts. The records (Exhibits 6 and 7) were subsequently produced by Respondent. It is likely that Respondent prepared Exhibits 6 and 7 subsequent to the arrest of Terri Baum shortly before the search was conducted. Subsequent to the arrest, Terri Baum and Pam Baum on February 26, 1986 had an appointment with Dr. Sayers Brenner, M.D., a psychiatrist, at which Terri requested Ritalin, Cylert and Fiorinal for herself and Ritalin and Cylert for Pam. Dr. Brenner, at the time unaware of Terri's arrest, prescribed a 10-day supply of these drugs and told Terri that he would not continue to supply drugs to her and that he did not treat adolescent patients. Although an appointment was made for a subsequent visit in two weeks, neither Terri nor Pam returned. Although no charges were made in this regard, evidence was presented in Exhibit 8 that Respondent wrote prescriptions for himself for Lasix, Lanoxin and Urecholine. No evidence was submitted from which a determination can be made that Respondent has a drug dependency problem, although the evidence is clear that if Respondent does not have a drug dependency problem, his wife does, and that prescriptions were written by Respondent to several fictitious persons to support this dependency.
Findings Of Fact Based upon my observation of the witnesses, their demeanor while testifying, the documentary evidence received and the entire record compiled herein, I make the following findings of fact: The Department of Health and Rehabilitative Services (??"HRS") is the regulatory agency charged with the administration of Chapter 499, Florida Statutes, which includes the issuance of permits to operate a drug wholesale facility. Sometime prior to December, 1986, Petitioner, Vetco International, Inc. d/b/a Pompano Vet Supply ("Vetco") was issued Wholesale Drug Permit Number 03:00375 by the Pharmacy Program of HRS. On December 15, 1986, HRS received an application from Thomas Karpinski, owner of Vetco, to renew Vetco's drug wholesale permit for 1987. On December 17, 1986, HRS denied Vetco's application for renewal of its wholesale drug permit for the year 1987. Vetco requested a formal administrative hearing on the denial and the matter was referred to the Division of Administrative Hearings where it was assigned Case No. 87-0832. A hearing was held in that case on August 18, 1987 by Hearing Officer, James Bradwell of the Division of Administrative Hearings. On March 28, 1988, Hearing Officer Bradwell entered a Recommended Order recommending that Vetco's renewal application for the year 1987 be denied. The basis for that recommendation was that the applicable statutes and rules required that facilities where drugs are held be made available for inspection; that on several occasions Vetco's facility was not made available to authorized agents of HRS for inspection; and that Vetco's denial of inspections to HRS constituted a substantial violation of Chapter 499, Florida Statutes and Rule 10D-45, Florida Administrative Code. Hearing Officer Bradwell's Recommended Order was approved and incorporated in a Final Order by HRS dated April 20, 1988. On May 16, 1988, Vetco filed a Notice of Administrative Appeal to the Fourth District Court of Appeal regarding the Final Order issued by HRS on April 20, 1988. The case number assigned by the District Court of Appeal was Case No. 88-1342. On June 23, 1988, Vetco filed a Motion for Imposition of Automatic Stay with the Fourth District Court of Appeal seeking to stay the effect of HRS' April 20, 1988 Final Order. The Motion to Stay was granted by the Fourth District Court of Appeal on July 15, 1988. On December 28, 1988, the Fourth District Court of Appeal, per curiam, affirmed HRS' April 20, 1988 Final Order. The Mandate from the Fourth District Court of Appeal was issued on January 13, 1989. During the time period between the conclusion of the formal administrative hearing in August, 1987 and the issuance of the Recommended Order by Hearing Officer Bradwell in March, 1988, counsel for Vetco initiated efforts to obtain a renewal of the drug wholesale permit for the year 1988. Vetco contends that it did not receive the standard 1988 renewal application form typically sent by HRS prior to the beginning of the new year. By letter dated January 21, 1988, counsel for Vetco advised HRS that Vetco intended to keep its license in effect. In that letter, counsel for Vetco submitted a check for the amount of the renewal fee and provided certain other information required as part of the renewal process. During the period from January, 1988 through May, 1988, there were several exchanges between counsel for Vetco and the representatives of HRS regarding the renewal for the year 1988. HRS took the position that the January 21, 1988 letter from counsel for Vetco could not serve as a renewal application because it was not signed by the owner of the company and was not submitted on the appropriate HRS form. Vetco contends that the January 21, 1988 letter included all of the information legally required to process the renewal application and should have been treated as a renewal application. After exchanging correspondence and phone calls with counsel for Vetco and obtaining a signed form from Vetco, HRS acknowledged on May 24, 1988, that the renewal application was complete. On June 6, 1988, HRS denied Vetco's application for license renewal for the year 1988 citing the Final Order filed on April 20, 1988 and the Findings of Fact set forth in the Recommended Order entered by Hearing Officer Bradwell on March 28, 1988 in connection with the 1987 renewal application. By petition filed June 30, 1988, Vetco sought a formal hearing on the denial of its 1988 renewal application. The matter was referred to the Division of Administrative Hearings and assigned Case No. 88-3596. It is one of the two cases consolidated in the current proceeding. As noted above, by order dated July 13, 1988, the Fourth District Court of Appeal stayed the effect of the Final Order regarding the 1987 renewal application and, by agreement of the parties, Division of Administrative Hearings Case No. 88-3596 was abated pending the decision of the Fourth District Court of Appeal on the 1987 renewal. Thus, Vetco was able to continue business operations uninterrupted throughout 1987 and 1988. On January 6, 1989, Vetco applied for renewal of its drug wholesale permit for the year 1989. By letter dated January 17, 1989, HRS refused to renew Vetco's permit for 1989 citing the Fourth District Court Of Appeal's decision on the 1987 application. On February 2, 1989, Vetco filed a Petition for Formal Hearing challenging this denial. The Petition for Formal Hearing was transferred to the Division of Administrative Hearings and assigned Case No. 89-717. It is the second case involved in this current proceeding. By order dated April 19, 1989, Division of Administrative Hearings' Case Nos. 88-3596 and 89-717 were consolidated.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is: RECOMMENDED: Petitioner's application for renewal of its wholesale drug permit No. 03:00375 for the year 1988 be dismissed as moot and the application for renewal for the year 1989 be DENIED. DONE and ENTERED in Tallahassee, Leon County, Florida, this 23rd day of August, 1989. J. STEPHEN MENTON Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 904/488-9675 Filed with the Clerk of the Division of Administrative Hearings this 23th day of August, 1989. APPENDIX TO RECOMMENDED ORDER, CASE NOs. 88-3596 AND 89-0717 The parties have submitted proposed findings of fact. It has been noted below which proposed findings of fact have been generally accepted and the paragraph number(s) in the Recommended Order where they have been accepted, if any. Those proposed findings of fact which have been rejected and the reason for their rejection have also been noted. The Petitioner's Proposed Findings of Fact Proposed Finding Paragraph Number in Recommended Order of Fact Number Findings of Fact where accepted or reason for rejection 1 2-7 2-12 Adopted in part in Findings of Fact 13-16, otherwise rejected as irrelevant. 13 Adopted in part in Findings of Fact 17, otherwise rejected as irrelevant. 14 Rejected as irrelevant. 15 Adopted in part in Findings of Fact 18-19, otherwise rejected as irrelevant. 16 Adopted in part in Findings of Fact 9-12 and 20, otherwise rejected as irrelevant. 17-21 Rejected as irrelevant. The Respondent's Proposed Findings of Fact The proposed findings of fact in Respondent's Proposed Recommended Order are not numbered. The individual paragraphs are treated as though separately numbered. Proposed Finding Paragraph Number in Recommended Order of Fact Paragraph Findings of Fact where accepted Number reason for rejection 1 3 2 Adopted in part in Findings of Fact 4, otherwise rejected as irrelevant. 3 Adopted in part in Findings of Fact 5, otherwise rejected as irrelevant. 4 6 5 6-7 6 8-12 COPIES FURNISHED: Karen Coolman Amlong, Esquire Amlong & Amlong, P.A. 101 N.E. 3rd Avenue 2nd Fl. Fort Lauderdale, Florida 33301 John Rodriguez, Esquire Technical Health Services, Department of Health and Rehabilitative Services 1317 Winewood Boulevard Building 1, Room 304 Tallahassee, Florida 32399-070 Sam Power, Agency Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 Gregory L. Coler, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 John Miller Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700
Findings Of Fact Dora F. Villanueva is a licensed pharmacist in the State of Florida, holding license number PS 0014957. Ms. Villanueva is an elderly woman who owns the Century Pharmacy, a community pharmacy located at 3017 S.W. 107th Avenue in Dade County, which holds permit number PH 0006839. She depends on the pharmacy for her livelihood and is manager of its prescription department. An investigator for the Department of Professional Regulation, Thomas Daniels, entered the Century Pharmacy in the early afternoon on January 7, 1988. He was there to follow up on a previous inspection of the Century Pharmacy. When Mr. Daniels arrived at the pharmacy, Ms. Villanueva, the registered pharmacist, was not there. It is Ms. Villanueva's practice to open the prescription department from 9:00 a.m. to 1:00 p.m. and 3:00 p.m. to 8:00 p.m. She returns to her home for lunch from 1:00 p.m. to 3:00 p.m. While there, Mr. Daniels, observed a person in the pharmacy department, who was visible through a pass-through window which connects the prescription department with the over- the-counter drug section of the pharmacy. That person was Mary Washington, a pharmacy technician who works at the Century Pharmacy. Ms. Washington is not, and never has been a licensed pharmacist. No other licensed pharmacist was present and on duty at the pharmacy. Ms. Villanueva is the only pharmacist employed at the Century Pharmacy. While Ms. Villanueva was absent, there was no sign indicating the pharmacy prescription department was closed due to the absence of a pharmacist. The records of the Board of Pharmacy admitted into evidence indicate that Ms. Villanueva was placed on probation on November 5, 1984, for one year. The reason for the probation cannot be determined from the records offered in evidence.
Recommendation It is, therefore, RECOMMENDED that Dora F. Villanueva and Century Pharmacy receive a reprimand and a fine of $400 for violations of Rule 21S-1.014, Florida Administrative Code. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 26th day of August, 1988. WILLIAM R. DORSEY, JR. Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1050 (904) 488-9765 Filed with the Clerk of the Division of Administrative Hearings this 26th day of August, 1988. APPENDIX Rulings on the proposed findings of fact and conclusions of law of the petitioner. Covered in finding of fact 1. Covered in finding of fact 2. Covered in finding of fact 2. Covered in finding of fact 4. Covered in finding of fact 4. Covered in finding of fact 4. Covered in finding of fact 5. Rulings on the proposed findings of fact and conclusions of law of the respondent. Covered in finding of fact 1. Covered in finding of fact 2. Covered in findings of fact 2 and 3. Generally covered in findings of fact 2 and 3. Rejected because I accepted the testimony of Mr. Daniels on this point, that there was no closed sign at all. Whether Dr. Villanueva places a sign in the dispensing window on most days cannot be determined from the evidence, but she did not do so on January 7, 1988. Rejected because I have accepted the testimony of Mr. Daniels that he saw Mary Washington in the pharmacy department. Rejected for the reasons stated in the preceding paragraph. COPIES FURNISHED: Michael A. Mone', Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Regla M. Sibila-Zaidner, Esquire 2260 S.W. 8th Street Suite 204 Miami, Florida 33135 Rod Presnell, Executive Director Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 William O'Neil, Esquire General Counsel Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750
The Issue Whether Petitioner should be granted a Retail Pharmacy Drug Wholesale Distribution Permit, pursuant to Subsection 499.01(2)(f), Florida Statutes (2009).1
Findings Of Fact Background Petitioner holds Florida Community Pharmacy License No. PH23699 (the “pharmacy license”), pursuant to Chapter 499, Florida Statutes. The establishment is located at 1507 Park Center Drive, Suite 1L, Orlando, Florida 32835 (“establishment”), where Petitioner’s records are stored. On or about July 29, 2009, Petitioner submitted the first portions an application to Respondent for a Retail Pharmacy Wholesaler Distributor Permit, pursuant to Subsection 499.01(2)(f), Florida Statutes (“application”). On September 16, 2009, Respondent's drug agents conducted an onsite inspection of the establishment (“inspection”) for purposes of assisting in Respondent’s determination of whether to issue the permit to Petitioner. On or about November 13, 2009, Respondent notified Petitioner that Respondent intended to deny the application (“notice”), and Petitioner filed a petition for administrative review, raising disputes of material fact (“petition”). Prescription Drug Inventory and Petition as a “Retail Pharmacy” To qualify as a retail pharmacy, Petitioner must have adequate inventory on hand that would be required by the general public for a variety of medical conditions. On the date of inspection, there was inadequate inventory on hand. There were only 18 commercially-available prescription drugs. Many of the drugs were injectables, which would only fill the needs of a very specific and limited patient population. At the time of inspection, Petitioner’s on-hand inventory of prescription drugs lacked any opiate painkillers and any drugs indicated for treatment or maintenance of (i) high blood cholesterol levels, (ii) systemic bacterial infections (oral antibiotics), (iii) osteoporosis, (iv) cough (syrups), (v) viral infections, (vi) depression, and (vii) asthma. These are some of the most commonly-required drugs in the pharmacological arsenal. Petitioner’s specialization in the area of compounded prescription drugs is evidenced by Petitioner’s prescription drug inventory and the nature of the prescriptions Petitioner filled in the months leading up to inspection. Most of Petitioner’s on-hand prescription drug inventory was composed of compounded prescription drugs or ingredients to be used in compounding prescription drugs. Less than eight percent of Petitioner's prescription drugs, or about 18 items, consisted of commercially-available prescription drugs in finished dosage forms. In the two-month period before September 29, 2009, Petitioner did not dispense a single dose of commercially- available, finished-form prescription drugs. All were specially-prepared or “compounded” products tailored to the specific needs of individual patients. Petitioner, as a result of an inability to meet the most basic and commonplace prescription drug needs of the general public, lacked adequate inventory required by the general public. Petitioner served a specific and limited patient population: i.e., those patients requiring specially-compounded prescription drugs and those rare patients whose needs could not be met by commercially-available products. Petitioner's explanation as to the reason for having only 18 commercially-available prescription drugs available at the time of inspection is not persuasive; Petitioner, therefore, was not a retail pharmacy. Life Specialty Pharmacy Medical Equipment and Supplies, Inc.: Petitioner’s Unauthorized Source for Prescription Drugs Life Specialty Pharmacy Medical Equipment and Supplies, Inc. (“Life Specialty”), a separate entity from Petitioner, is under common control with Petitioner. It has the same owners, principals, and pharmacy department manager. Life Specialty holds Community and Special Parenteral/Enteral Pharmacy License No. PH22346 for an establishment located at 1507 Park Center Drive, Suite 1L, Orlando, Florida 32835. It is not authorized under Florida law to purchase, receive, own, or distribute prescription drugs. Petitioner’s prescription drug inventory at the time of inspection included certain quantities of Sarapin, a prescription drug. Life Specialty acquired and received Sarapin from a Kmart pharmacy that is no longer in business. At the time Life Specialty acquired and received the Sarapin from Kmart pharmacy, that drug was readily available from Life Specialty’s prescription drug wholesale suppliers. Life Specialty later transferred the Sarapin to Petitioner. Life Specialty lacks any permit or authorization under Part I of the Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes (Act), to engage in the wholesale distribution of prescription drugs. Petitioner, nevertheless, received prescription drugs from Life Specialty, and many of these drugs were in Petitioner’s prescription drug inventory at the time of inspection, including prescription drugs compounded by Life Specialty. Those drugs included: Sarapin Ketamine Hydrochorlide USP Progesterone Micro USP Chloral Hydrate (CIV), Crystal USP 100% 125gm Testosterone Propionate Micro USP Ketamine Hydrochloride USP 100% Powder 25mg Amphotericin B USP 100% Powder 1gm Cyclobenzaprine HCl USP Recordkeeping and Pedigree Papers During the course of the inspection, Respondent requested the opportunity to review pedigree papers and other source-related records for the prescription drugs Petitioner received from Life Specialty. Specifically, Petitioner could not produce any pedigree papers for prescription drugs received from Life Specialty. Petitioner received from Life Specialty, without a valid pedigree paper, the following: Sarapin Ketamine Hydrochorlide USP Progesterone Micro USP Testosterone Propionate Micro USP Cyclobenzaprine HCl USP Recordkeeping Petitioner did not acquire all of its pedigree papers contemporaneously with the underlying transactions. Petitioner acquired many of the pedigree papers for the prescription drugs in its inventory after the Respondent's inspection. Petitioner's explanation for these failures was not credible.
Recommendation Based on the Findings of Facts and the Conclusion of Law cited above, it is RECOMMENDED that the Department of Health enter a final order, denying Petitioner's application for a permit to act as a retail pharmacy drug wholesale distributor. DONE AND ENTERED this 1st day of September, 2010, in Tallahassee, Leon County, Florida. S DANIEL M. KILBRIDE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 1st day of September, 2010.
The Issue Whether Respondent committed the violation alleged in the Administrative Complaint, and, if so, what disciplinary action should be taken against her.
Findings Of Fact Based upon the evidence adduced at the final hearing and the record as a whole, the following findings of fact are made: Respondent is now, and has been since 1976, a Florida-licensed pharmacist. At all times material to the instant case, Respondent was employed by Eckerd Corporation as one of two full-time pharmacists assigned to the Eckerd Drug Store (Store Number 3372) located at 312 North Lake Boulevard in North Palm Beach, Florida, which housed a community pharmacy that was open 14 hours a day. Respondent and the store's other full-time pharmacist worked separate, alternating shifts. At the beginning of each shift, Respondent "signed on" the pharmacy's computer system. She "logged off" the system at the end of the shift. Respondent was responsible for the supervision of all activities in the pharmacy during her shift. Among the activities it was her responsibility to supervise were those engaged in by the pharmacy technician on duty. The pharmacy technician assisted Respondent by, among other things, preparing computer-generated prescription labels and customer receipts for prescriptions that needed to be filled. The technician prepared these items by entering the required information, including the name and strength of the prescribed medication, into the pharmacy's computer system. 1/ All prescription labels and customer receipts prepared by the pharmacy technician on duty during Respondent's shift contained Respondent's initials ("MCB"). After they were prepared, the prescription labels and customer receipts were placed in bags, and the bags were put in baskets on the counter near Respondent, where they remained until the prescriptions were filled. When filling a prescription, it was Respondent's practice to examine the actual prescription written by the prescribing physician or, in the case of an oral prescription, the pharmacy's written record of such prescription, to confirm the accuracy of the prescription information on the prescription label and customer receipt and to make sure that she was dispensing what the physician had prescribed. 2/ The pharmacy was a "very busy" one. As a result, at the end of her shift, there were sometimes prescriptions for which labels and receipts (bearing her initials) had been prepared, but which Respondent had not had the opportunity to fill, and it was not until the following shift, when she was off duty, that these prescriptions were actually filled. Respondent was on duty on June 18, 1998, when a computer-generated prescription label and customer receipt for a prescription (Prescription Number 6071853) for Patient H. V. were prepared. The computer-generated prescription label and customer receipt, which had Respondent's initials on them, indicated, among other things, that the prescription was for 15 180 milligram tablets of Thyroid and that the prescribing physician was Dr. H. Pomeranz. It is unclear when, and by whom, Prescription Number 6071853 was filled. On or about October 9, 1998, Patient H. V.'s son, R. V., filed a complaint with Petitioner alleging that "the prescription [his mother] was suppose[d] to [have] be[en] taking was 15 mil[li]grams," but she instead "was given 180 mil[lli]grams per day by [the] Eckerd Drug Store [on North Lake Boulevard]." David Dimon, a Medical Malpractice Investigator with the Agency for Health Care Administration, investigated the complaint. As part of his investigation, Mr. Dimon contacted Respondent, who advised him that she did not want to make a statement regarding the complaint. Mr. Dimon also spoke with the prescribing physician, Dr. Pomeranz, who told him that she "prescribed Thyroid, 15 milligrams, for the patient, and not the 180 milligram dose given by Eckerd Pharmacy." 3/ Dr. Pomeranz further indicated to Mr. Dimon that H. V. 4/ suffered "side effects" as a result of taking the 180 milligram tablets.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is hereby RECOMMENDED that the Board enter a final order dismissing the Administrative Complaint issued against Respondent in its entirety. DONE AND ENTERED this 13th day of March, 2001, in Tallahassee, Leon County, Florida. ___________________________________ STUART M. LERNER 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 13th day of March, 2001.
