The Issue Whether Respondent's permit to operate a pharmacy should be suspended or revoked for alleged violations of Sections 465.22(1)(c), 465.18(1)(b), 465.18(2)(b) F.S., and Rule 21S-1.14 F.A.C. At the hearing, Petitioner withdrew Count-I of the Complaint. Respondent's Motion To Dismiss Counts II and III of the Complaint at the conclusion of Petitioner's case in chief was denied.
Findings Of Fact Respondent presently holds and did so hold at the time of the events alleged in the Complaint a permit to operate a pharmacy issued by Petitioner (Stipulation.) Prior to the events alleged in the Complaint, Petitioner's agent, Vernon K. Bell, an inspector, obtained an authentic prescription from another pharmacy that had not been picked up by a customer, for use in investigations of other pharmacies. The prescription was issued by Dr. George A. Fernandez, Miami, Florida, Number 012194, dated December 11, 1975, to Fela Rivias and was for twenty-one tablets of Erythrocin, 250 miligrams. Erythrocin is an antibiotic prescription drug used for various infections (Testimony of Bell, Petitioner's Exhibit 1.) On December 19, 1975, Bell visited Respondent's pharmacy and observed that the door to the prescription area was unlocked. On December 22, 1975, at approximately 3:30 P.M., Reynaldo Santiago, another agent of the Board of Pharmacy, entered Respondent's pharmacy with the prescription referred to in paragraph 2 above that had been given to him by Bell. Santiago gave it to the cashier to be filled. He observed her go to the prescription department, open a door, and place the prescription on a counter. He then observed Hildelisa Hernandez go to the prescription department and start filling the prescription. Thereafter, Ms. Hernandez, accompanied by Mr. Jose E. Valdez, came out of the prescription area and Hernandez gave a pill bottle to the cashier. The cashier in turn gave it to Santiago for the price of $3.95 or $4.00. The bottle contained 21 tablets and a label affixed thereon contained pertinent information as set forth in the prescription that Santiago had given to that cashier, including the name of the drug, doctor, prescription number and name of patient (Testimony of Santiago, Petitioner's Exhibit 2.) Santiago took the bottle of pills outside and then he and Bell re- entered the Pharmacy. Bell identified himself to Mr. Valdez and asked him who was his registered pharmacist and if he had a pharmacist on duty. Mr. Valdez stated that Hal Glass was his pharmacist, but that he had left the store at 2:00 P.M. Bell then asked Valdez if he had filled the prescription which Santiago had taken into the store and, after some hesitation, Bell asked Hernandez if she had filled it. She replied in the affirmative. She stated that she was not a licensed pharmacist in Florida, but had been a pharmacist in Cuba. Bell then wrote a violation and left the store. Neither he nor Santiago recalled seeing a sign indicating that the prescription department was closed on December 22 (Testimony of Bell, Santiago.) Jose E. Valdez testified that although he formerly had two pharmacists at his previous pharmacy, in August or September of 1975 he was forced to cut back to one part-time pharmacist because of the bad economic situation. He conceded that Ms. Hernandez was not a registered Florida pharmacist. He also stated that he was not aware of the rules requiring that the prescription department be locked when no pharmacist was present until this incident occurred and that, in fact, the door to the prescription area had not been locked although a sign indicating that the prescription department was closed had always been used. He further testified that on February 1, 1976, he hired a full-time pharmacist who is present at all times when the pharmacy is open and that the prescription department is now always locked when she is not present.
Recommendation That a civil penalty in the sum of $250.00 be imposed against Respondent in lieu of suspension or revocation of its permit, for violation of Section 465.18(1)(b), Florida Statutes, and Rule 21S-1.14, Florida Administrative Code DONE and ENTERED this 26th day of April, 1976, in Tallahassee, Florida. THOMAS C. OLDHAM Hearing Officer Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 COPIES FURNISHED: Stanley Kaplan, Esquire 404 Biscayne Building Miami, Florida Seymour M. Litman, Esquire 10 Northwest 14 Avenue Miami, Florida 33125
The Issue These two consolidated cases are both license discipline cases in which the Petitioner seeks to take disciplinary action against an individual pharmacist and a community pharmacy for various statutory violations which are alleged in separate Administrative Complaints. At the hearing the Respondents admitted some of the allegations of the Administrative Complaints. Thereafter both the Petitioner and the Respondents presented testimony and exhibits. At the conclusion of the hearing, the parties decided not to order a transcript of the hearing. The parties were allowed until November 25, 1987, within which to file their proposed recommended orders. Both parties filed timely proposed recommended orders containing proposed findings of fact and conclusions of law. Specific rulings on all proposed findings of fact submitted by the parties are contained in the Appendix which is attached to and incorpor- ated into this recommended order.
Findings Of Fact Based on the stipulations and admissions of the parties, on the exhibits received in evidence, and on the testimony of the witnesses at hearing, I make the following findings of fact. Findings based on stipulations and admissions Respondent Gus Goldstein is, and has been at all times material hereto, a pharmacist in the State of Florida, having been issued license number PS 0005354. Respondent's last known address is 110 East Adams Street, Jacksonville, Florida 32202. Respondent Gus Goldstein is and has been at all times material hereto, designated as the prescription department manager of Center Pharmacy, a community pharmacy in the State of Florida, having been issued permit number PH 0002430 and located at 110 East Adams Street, Jacksonville, Florida 32202. On or about December 23, 1986, a pharmacy medication audit was conducted at Center Pharmacy for the period between approximately June 1, 1986, and December 23, 1986. That audit revealed that the Respondents' records for the period of June 1, 1986, through December 23, 1986, failed to account for the following: Description Bought Dispensed Unaccounted For Tylenol #3 w/codeine 4200 2102 2098 Tylenol #4 w/codeine 5000 2600 2400 Fiorinal #3 1900 1810 90 Valium 5mg. 900 380 520 (Diazepam 5mg.) Valium 10mg. 2200 1600 600 (Diazepam 10mg.) Tylenol #3 with Codeine and APAP with Codeine 30mg are "medicinal drugs" as defined in Section 465.003(7), Florida Statutes, which contain codeine, a controlled substance, in such quantity that they are included in Schedule III of Chapter 893, Florida Statutes. Tylenol #4 with Codeine and APAP with Codeine 60mg are "medicinal drugs" as defined in Section 465.003(7), Florida Statutes, which contain codeine, a controlled substance, in such quantity that they are included in Schedule III of Chapter 893, Florida Statutes. Fiorinal #3 with Codeine is a "medicinal drug" as defined in Section 465.003(7), Florida Statutes, which contains codeine, a controlled substance, in such quantity as to be included in Schedule III of Chapter 893, Florida Statutes. Valium is a brand name of a "medicinal drug" as defined in Section 465.003(7), Florida Statutes, which contains diazepam, a controlled substance, which is listed in Schedule IV of Chapter 893, Florida Statutes. Tylenol #3 with Codeine is a brand name of a "medicinal drug" as defined in Section 465.003(7), Florida Statutes, which contains a sufficient quantity of codeine, a controlled substance, to be listed in Schedule III of Chapter 893, Florida Statutes. Respondent Center Pharmacy is, and has been at all times material hereto, the permittee of Center Pharmacy, a community pharmacy, located in the State of Florida at 110 East Adams Street, Jacksonville, Florida 32202, having been issued permit number PH 0002430. Respondent Center Pharmacy has, and had at all times material hereto, Gus Goldstein, a pharmacist in the State of Florida having been issued license number PS 0005354, designated as its prescription department manager. Respondent Center Pharmacy is, and has been at all times material hereto, registered with the United States Drug Enforcement Administration. Respondent has been issued certificate of Registration Number AC 5050719. Findings based on the evidence adduced at the hearing On or about October 27, 1986, Respondent Gus Goldstein created a record which purported to be a telephone prescription (#116-450) for F.W. for Tylenol #3 with Codeine, purportedly prescribed by Dr. Samuel J. Alford, M.D. The prescription (#116-450) for F.W. for Tylenol #3 with Codeine was not authorized by Dr. Samuel J. Alford, M.D. Respondent Gus Goldstein dispensed Tylenol #3 with Codeine to F.W. without first being furnished with a prescription. Respondent Gus Goldstein knew that the purported telephone prescription (#116-450) for F.W. was a false record. During the process of dispensing drugs, normally there will be small errors in the counting of the drugs. These small errors will result in shortages in the drug inventory which cannot be accounted for. If proper record-keeping and dispensing practices are followed, the shortages resulting from these small errors normally will be in the range of from 1 percent to 2 percent of drugs dispensed; certainly no more than 3 percent of drugs dispensed. Shortages greater than 3 percent of drugs dispensed are indicative of a failure to follow proper record- keeping and dispensing practices.
Recommendation Based on all of the foregoing, I recommend that the Board of Pharmacy enter a final order in these consolidated cases to the following effect: Finding the Respondent Gus Goldstein guilty of the violations charged in Counts One, Two, and Three of the Administrative Complaint in Case Number 87-3151; Dismissing the violation charged against Gus Goldstein in Count Four of the Administrative Complaint in Case Number 87- 3151; Imposing an administrative fine against Gus Goldstein in the amount of five hundred dollars ($500.00) for each of the violations of which he is found guilty; i.e., administrative fines totaling fifteen hundred dollars ($1,500.00); Revoking Gus Goldstein's license to practice pharmacy; Finding the Respondent Center Pharmacy guilty of the violation charged in the Administrative Complaint in Case Number 87-3913; Imposing an administrative fine against Respondent Center Pharmacy in the amount of five hundred dollars ($500.00); and Revoking the permit of Center Pharmacy. DONE AND ENTERED this 9th day of December, 1987, at Tallahassee, 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 9th day of December, 1987. APPENDIX TO RECOMMENDED ORDER, CASE NOS. 87-3151 AND 87-3913 The following are my specific rulings on all of the findings of fact proposed by the parties. In the rulings which follow I have rejected much of what both parties offered as proposed findings of fact due to the form of the proposals. The most frequent defect in the form is the commencement of a statement with the words "So-and-so testified," followed by a summary of the testimony. Testimony is, of course, one of the raw materials from which findings of fact are made, but (with the exception of perjury trials) summarization or quotation of testimony is hardly ever an appropriate finding of fact. Rather than summarize or quote the testimony, the parties should refine from the testimony the essential material and relevant facts and submit that refined product as their proposed findings. Findings proposed by Petitioner: Paragraph 1: Accepted. Paragraph 2: Rejected for the following reasons: First, it is a summary of testimony, rather than proposed findings of fact; second, parts of it are inconsistent with the greater weight of the evidence; and, third, most of it consists of subordinate, irrelevant, or unnecessary details. First unnumbered paragraph following Par. 2: Rejected for the first and third reasons noted immediately above. Second unnumbered paragraph following Par. 2: Rejected as a commentary on the evidence rather than a proposed finding of fact. Further, the portion following the comma is inconsistent with the greater weight of the evidence. Paragraph 3: Rejected for the same reasons as rejection of Paragraph 2. Unnumbered paragraph following Par. 3: Rejected for the following reasons: First it is a summary of the testimony, rather than proposed findings of fact, and, second, most of it consists of subordinate, irrelevant, or unnecessary details. Paragraph 4: Rejected as constituting a summary of testimony rather than proposed findings of fact. Last unnumbered paragraph: Rejected as constituting argument or conclusions of law rather than proposed findings of fact. Findings proposed by Respondents: Paragraph 1: Accepted. Paragraph 2: Covered in part by stipulated facts. Most of the remainder rejected as subordinate or unnecessary details or as not supported by competent substantial evidence. First unnumbered paragraph following Par. 2: First three sentences rejected as summary of testimony rather than proposed findings of fact. Second and third sentences also rejected as not being supported by persuasive competent substantial evidence. The remainder of this paragraph is rejected as consisting of subordinate, irrelevant, or unnecessary details. Second unnumbered paragraph following Par 2: Rejected as constituting a summary of testimony rather than proposed findings of fact and because it constitutes subordinate, irrelevant, or unnecessary details. Paragraph 3: Rejected as irrelevant and as not supported by competent substantial evidence. First unnumbered paragraph following Par. 3: Rejected as constituting argument or legal conclusions rather than proposed findings of fact. Second unnumbered paragraph following Par. 3: Rejected as constituting argument or legal conclusions rather than proposed findings of fact. Further, portions of the arguments and conclusions are based on inferences which are not warranted by the evidence. Paragraph 4: Rejected as summary of testimony rather than proposed findings of fact and as constituting subordinate and unnecessary details. First unnumbered paragraph following Par. 4: Rejected for the same reasons as rejection of Paragraph 4. Second unnumbered paragraph following Par. 4: First sentence rejected as constituting argument rather than proposed findings of fact. Second sentence accepted in substance. Last sentence accepted. COPIES FURNISHED: Mr. Rod Presnell Executive Director Board of Pharmacy 130 North Monroe Street Tallahassee, Florida 32399-0750 William O'Neil, Esquire General Counsel Dept. of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32399-0750 Michael A. Atter, Esquire 333-1 East Monroe Street Jacksonville, Florida 32202
The Issue At issue in this proceeding is whether Respondent committed the offenses set forth in the Administrative Complaint1 and, if so, what penalty should be imposed.
Findings Of Fact Respondent's licensure and employment Respondent, Nury D. Soler, is now, and was at all times material hereto, licensed as a pharmacist by the State of Florida, having been issued license number PS 0014628. Pertinent to this case, Respondent was the prescription department manager for Westchester Pharmacy for a two-month period extending from some time in October 1996 and at least through December 13, 1996. Westchester Pharmacy is a community pharmacy licensed by Petitioner, pursuant to Section 465.018, Florida Statutes, and located at 7253 Southwest 24th Street, Miami, Florida. The pharmacy owner or permittee was Noriel Batista. The pharmacy inspection On December 14, 1996, a Saturday, Richard Castillo, an investigator employed by the State of Florida, entered the Westchester Pharmacy to conduct a routine community pharmacy inspection. Upon entry, Mr. Castillo observed only one person in the pharmacy, a man later identified as the permittee (Mr. Batista). At the time, Mr. Batista was observed in the vicinity of the prescription area, at the rear of the store. Mr. Castillo proceeded to the counter at the rear of the store, and was approached by Mr. Batista. Thereupon, Mr. Castillo feigned a toothache, and the following events transpired: . . . I put my hands on my face and I said I have some tooth pain, is there anything you can do about it. At which time, he said you really need to go see a dentist. I said that dentists cost a lot of money and that I believed that it was an infection. At which time he came back with a bottle of twenty Amoxicillin, 500 milligram capsules. He sold me the bottle for $10.00 and I gave him the $10.00. He then gave me some preliminary instructions, and went back into the prescription department area. He returned and said that as a gift I'm going to give you these medications; which was four capsules of Motrin 800 milligrams. Amoxicillin is a prescription drug, which Mr. Batista, who was not licensed as a pharmacist, sold without benefit of a prescription. Following the sale, Mr. Castillo identified himself as an investigator, told Mr. Batista he was present to conduct a routine inspection, and asked to speak with the pharmacist. When told the pharmacist was not available, Mr. Castillo asked Mr. Batista to telephone her and ask her to come to the store. Mr. Batista did so, and about an hour later Respondent arrived. Mr. Castillo inspected the pharmacy and completed a community pharmacy inspection report on which he noted a number of perceived deficiencies. (Petitioner's Exhibit 2). First, with regard to Mr. Batista's sale of amoxicillin, Mr. Castillo noted three deficiencies or violations against the pharmacy business, to-wit: (1) there was no pharmacist on duty when the prescription department was open (a perceived violation of Rule 64B16-28.109, Florida Administrative Code); (2) there was no pharmacist present to provide patient counseling, if requested (a perceived violation of Rule 64B16-27.820, Florida Administrative Code); and, (3) since Mr. Batista did not document the sale, Mr. Castillo considered the pharmacy records of dispensing to be incomplete (a perceived violation of Rule 64B16-28.140(3)(b), Florida Administrative Code). Other deficiencies noted by Mr. Castillo against the pharmacy business were as follows: (1) there was no sign displayed that the pharmacy was closed (a perceived violation of Rule 64B16-28.109(1), Florida Administrative Code); (2) the pharmacist's (Ms. Soler's) license was not displayed (a perceived violation of Rule 64B16-27.100(1), Florida Administrative Code); and, (3) there was no sign displayed which stated the hours the prescription department was open each day (a perceived violation of Rule 64B16-28.404, Florida Administrative Code). No further deficiencies were observed and, apart from those noted deficiencies, the prescription department appeared appropriately maintained and operated. Following Respondent's arrival at the pharmacy, Mr. Castillo discussed with her the various deficiencies he had found and had noted on his report. Then, as the "Pharmacist," Respondent signed the report. By signing the report, she acknowledged that "I have read and have had this inspection report and the laws and regulations concerned herein explained, and do affirm that the information given herein is true and correct to the best of my knowledge." Among the information provided on the inspection report was the name of the prescription department manager, which was stated to be the Respondent. Respondent's employment status with Westchester Pharmacy on the date of the inspection Notwithstanding her appearance at Westchester Pharmacy on Saturday, December 14, 1996, and her signing of the inspection report as the Pharmacist for Westchester Pharmacy, Respondent averred, at hearing, that by December 14, 1996, she was no longer affiliated with the pharmacy or responsible for the deficiencies noted. According to Respondent, by December 12, 1996, she had agreed with another pharmacy, Coral Way Pharmacy, Inc., (Coral Way Pharmacy) to serve as its pharmacist effective December 16, 1996, at its pharmacy located at 6965 Southwest 24th Street, Miami, Florida, and that her last date of employment with Westchester Pharmacy was December 13, 1996. While perhaps not entirely free from doubt (given the facial inconsistency between Respondent's contention at hearing and the conclusion one could reasonably draw regarding her association with Westchester Pharmacy, as evidenced by her activities on the date of inspection), the proof demonstrates, more likely than not, that, as Respondent averred, she was no longer employed by Westchester Pharmacy on the day of inspection, her presence on the day of inspection was a matter of accommodation to Mr. Batista, and her signing of the report was a matter of misunderstanding. In so concluding, it is observed that, while the pharmacy was open Monday through Saturday, the prescription department was not open on Saturday, or, stated differently, under the terms of Respondent's employment with Weschester Pharmacy she did not work week-ends. Given that Respondent and Coral Way Pharmacy, reached an agreement on December 12, 1996, for her to begin work at Coral Way Pharmacy on December 16, 1996, it is reasonable to conclude, given the nature of her work-week at Westchester Pharmacy, that her last day of employment with Westchester Pharmacy was Friday, December 13, 1996. Moreover, consistent with the conclusion that Respondent's association with Weschester Pharmacy terminated on December 13, 1996, is the absence of Respondent's wall certificate and license on the date of inspection. Notably, Respondent had not suffered prior disciplinary action in 19 years of practice, and presumably knew that, if employed, she was required to display her wall certificate and license in or near the prescription department. Conversely, she also knew, presumably, that she could not lawfully display them, if she was no longer employed by Westchester Pharmacy. Rule 64B16-27.100, Florida Administrative Code. Since it is presumed that persons will observe the law, the absence of Respondent's wall certificate and license on the date of inspection is consistent with her assertion that, by that date, she was no longer employed by Westchester Pharmacy. Atlantic Coast Line R. Co. v. Mach, 57 So. 2d 447 (Fla. 1952). Finally, also consistent with the conclusion that Respondent's employment with Westchester Pharmacy terminated before the date of the inspection is a statement Respondent made to the inspector. According to the investigator, when asked about the infractions, Respondent stated the following: . . . She said that things needed to change. She asked if she were to leave the pharmacy whether that would change anything, and I said, no, it doesn't matter because you're the pharmacist of record at this point of time. Such statement, when considered in context with other proof of record, discussed supra, is consistent with Respondent having resolved, previously, to terminate her employment with Weschester Pharmacy and, since she did not specifically tell the investigator of her decision, his response evidenced a misunderstanding that resulted in Respondent's execution of the report.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered dismissing the Administrative Complaint. DONE AND ENTERED this 25th day of August, 1998, in Tallahassee, Leon County, Florida. WILLIAM J. KENDRICK 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 Filed with the Clerk of the Division of Administrative Hearings this 25th day of August, 1998.
The Issue The issue is whether Norwood Pines' annual licensure to operate an adult congregate living facility should be renewed. The Department denied renewal because of repeated failures to correct deficiencies at the facility, and due to the necessity to impose a moratorium on admissions on March 31, 1989, due to conditions at the home which threatened the health, safety, and welfare of residents.
Findings Of Fact Norwood Pines had been licensed as an Adult Congregate Living Facility (ACLF) under the "Adulte Congregate Living Facilities Act", Part II, Chapter 400, Florida Statutes. It had a licensed capacity of four beds. A survey of Norwood Pines was conducted by Lorraine Grissom, a registered nurse who serves as a senior community health nursing consultant for the Department. She regularly conducts ACLF licensure surveys. An ACLF is a home which provides housing, food service, and personal services for adults, which may include limited nursing services when the home is specifically licensed to do so. Section 400.402(2), Florida Statutes. An ACLF license is good for only one year. Section 400.417(1), Florida Statutes. At the time of the survey on March 31, 1989, four elderly women resided at the Norwood Pines ACLF: J.M., R.R., B.A.; and a fourth resident whose condition is not at issue in this proceeding. The home had been established by David Winfrey, and his wife, Barbara Winfrey, who is a registered nurse. Barbara Winfrey had been involved in the operation of the facility but had turned over responsibility for the ACLF to Mr. Winfrey. At the time of the survey on March 31, 1989, she was but of town, out of touch, and unavailable to consult with the aide at the home about problems with any of the residents. On her first visit Ms. Grissom observed one of the aides at the home was under the influence of come substance (whether alcohol or drugs could not be readily determined). The aide's gait was unsteady (she stumbled several times), her speech was slurred, and the content of her conversation was disorganized. The aides had never been given written job descriptions outlining their duties and responsibilities in providing personal care to the residents. Two residents at the ACLF were inappropriate for ACLF care. J.M. was incontinent, confused, and needed care beyond that which Norwood Pines was able to provide. Rule 10A- 5.0181(3)(a)1.e., Florida Administrative Code. B.A. was confused and disoriented; would wander outside in the rain, needed to be watched constantly; and needed to have drugs administered, because she was too disoriented to medicate herself. Rule 10A- 5.018(2)(a)4.c., Florida Administrative Code. B.A. was so disoriented that in case of fire she could not preserve herself or follow directions. Rule 10A-5.0181(2)(a)4.f., Florida Administrative Code. Food service at the home was inappropriate in that menus had not been dated and planned one week in advance, and menus were not followed in the preparation and service of food. Mr. Winfrey did not contest this survey finding, although he did maintain that residents got enough to eat. The administration of medications to residents was a severe problem at the home. There were problems with the supervision of administration of medications, the maintenance of proper medication records, and proper storage and labeling of medications. If a resident is fully capable of taking her own medication, she may purchase and maintain in her own room over- the-counter drugs such as aspirin or rolaids without a prescription, and without the necessity of a label showing the name of the resident, the name of the prescribing M.D. and instructions for the use of the medication. If the facility undertakes the responsibility for supervision of self- administered medications, staff must read the medication label to the resident when it is taken, check self-administered dosages against the label of the container, and assure that resident obtains and takes the dosage prescribed. Rules 10A-5.013(2)(jj) and 10A-5.024(1)(c), Florida Administrative Code. Medicines may be centrally stored but medicines so stored must be kept locked. Rule 10A-5.0182(3)(a)4.a., Florida Administrative Code. Resident R.R. was seen removing Excedrin from an unsecured cabinet in violation of the rule. The centrally stored medicines were not labeled with the name of the resident, the dose, the M.D. who prescribed it, and the directions for use, in violation of Rule 10A-5.0182(3)(a)5., Florida Administrative Code. A medication sheet was not kept for the medication administered to residents, contrary to Rule 10-5.024(1)(c), Florida Administrative Code. For example, resident R.R. had a prescription for 30 Tylenol #3 tablets filled on March 25, 1984. Although 5 tablets were left in the bottle on March 31, 1989, there is no indication on her medication sheet that she had been provided those tablets. This violates Rule 10A-5.0182(3)(b)2.h. and (c)1., Florida Administrative Code. In addition, there was no indication that Peri- Colace, which had been ordered by a physician for resident J.M., had been given. Staff advised Ms. Grissom that J.M. had not been given the medicine during the month of March because J.M. could not swallow it. This information was not given to J.M.'s physician. As a result, J.M. became impacted with feces. Staff was then instructed to administer Ex-lax to J.M. without a physician's order, and not to document its use on the medication sheet for J.M. Staff also gave J.M. a Fleet enema, without a physician's order. This was not proper treatment for the impaction. As a result of the impaction, JAM. had refused to eat for 2-3 days, was lethargic and was aspirating mucus. She also had difficulty breathing. The aide did not notify J.M.'s physician of this, even though her condition was a significant deviation from J.M.'s normal state of health, in violation of Rule 10A-5.0182 (1)(d), Florida Administrative Code. Resident B.A. needed to have her medication actually administered to her, rather than having supervision in taking her own medication. Staff at an ACLF may administer medication to a resident if there is a licensed RN or LPN on staff. There was no nurse at Norwood Pines to administer medication; it was done by an untrained, unlicensed aide, in violation of Rule 10A-5.0182(3)(b) and (c), Florida Administrative Code. This is especially significant because the medications involved were psychotropic drugs such as Mellaril, which the doctor ordered to be administered on an "as needed" basis for depression. This medication was given daily, because the aide did not know how to recognize behaviors which show that it was needed, something which a LPN or RN could be trained to recognize. Daily administration of Mellaril is dangerous, and contrary to the physician's instructions. The side effects of Mellaril can be severe shaking and involuntary movements, which is a particularly high risk for elderly persons, and can be irreversible. Other drugs which did appear on the medication sheets for patients on March 31, 1989, such as Lanoxin, and Haldol were not in the ACLF and therefore could not be administered as required. These violations found on March 31, 1989, had been brought to the attention of the Administrator before. Unlabeled medications, use of unlicensed staff to give medication and the lack of health assessments had been cited as deficiencies on the October 22, 1988, survey. Ms. Grissom returned on May 31, 1989, for a follow- up survey to see whether the deficiencies identified on March 31, 1989, had been corrected. All of the deficiencies remained uncorrected, including those related to proper storage, labeling, recording and supervision of the administration of medication; to the criteria for retaining residents at the home; to staff awareness of health and well-being of residents; and to provision of appropriate staff and food service. The Administrator, Mr. Winfrey, did not contest that these deficiencies had not been corrected on May 31, 1989. On May 31, 1989, Mellaril was still being given to R.R. by an untrained, unlicensed aide when the physician required that it be given on an "as needed" basis. Five hundred milligrams of calcium was being given to R.R., although the medication was unlabeled, and there was no doctor's order to provide it. A doctor had ordered that potassium be given to B.A. with plenty of water and with food, but she was given only a small amount of orange juice in a four ounce cup with the potassium. Ms. Grissom explained that it is dangerous to give potassium in a manner other than as ordered to patients with heart problems such as B.A. The medication records did not show that two other medications given for heart disease, Lanoxin and Lasix were being given daily as prescribed. B.A. was still a resident at the home on May 31, 1989, though she was still so disoriented that it was inappropriate for her to be in an ACLF. B.A. was only transferred to a facility appropriate for her care after Ms. Grissom made another visit on October 30, 1989. On May 31, 1989, staff was still unable to perform duties and ensure proper care of residents because the untrained aide was still responsible for administering psychotropic medications to residents. A final appraisal of the home was done on October 30, 1989, by Ms. Grissom. At that time, untrained, unlicensed staff was still administering medications and admitted doing so. As noted above, B.A. who was an inappropriate client, still resided at the facility. Medication records were still as inaccurate as they had been on March 31 and May 31, 1989. The daily records were not being kept as medications were given. When Ms. Grissom asked the aide for the resident's files, the aide brought menus. In short, the aide was unprepared to do those things expected of her. Health assessments for the residents were not available, although the facility had been cited for this deficiency in the October 28, 1988, survey. By the October visit, Haldol had been ordered for B.A. by her physician, to be administered "as needed," but was given as a regular dose. Mellaril, another dangerous drug, had been ordered to be given up to three times a day as needed for depression to R.R., but it was given three times a day as a regular dose, even though R.R. showed no signs of depression. None of the findings about the October 30, 1989, were controverted by Mr. Winfrey. As a result of the March 31, 1989, survey a moratorium on admissions was imposed at the Norwood Pines ACLF due to conditions which threatened the residents' health, safety, and welfare. Norwood Pines did not appeal the moratorium.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered denying the request of Norwood Pines for a renewal license to operate an Adult Congregate Living Facility. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 27th day of March, 1990. WILLIAM R. DORSEY, JR. 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 27th day of March, 1990. APPENDIX TO RECOMMENDED ORDER DOAH CASE NO. 89-4346 The substance of the proposals submitted by the Department have been accepted. No proposed findings of fact were submitted by Norwood Pines. COPIES FURNISHED: Leonard T. Helfand, Esquire Department of Health and Rehabilitative Services 401 Northwest Second Avenue North Tower, Room 526 Miami, Florida 33128 David G. Winfrey Norwood Pines 19021 Northwest 10th Street Miami, Florida 33169 Sam Power, Agency Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 John Miller, General Counsel Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700
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.
