The Issue Whether Petitioner has been substantially affected by agency statements made by Respondent, and, if so, whether the statements violate section 120.54(1)(a), Florida Statutes?
Findings Of Fact Petitioner, Harmony Environmental (Harmony), is duly- licensed as a Universal Waste Transporter Facility (UWTF) with the Florida Department of Environmental Protection (FDEP), holding EPA ID No. FLR000202424. Additionally, Harmony is registered as a Hazardous Waste Transporter by FDEP as well as the U.S. Department of Transportation (USDOT); a Used Oil Handler by FDEP; a Biomedical Waste Transporter by the Florida Department of Health; and as a Waste Transporter by Broward and Miami-Dade counties. Respondent is the state department charged with regulating drugs, devices, and cosmetics pursuant to section 20.165 and chapter 499, Florida Statutes. Respondent does not have jurisdiction over the permitting of universal waste transporters or over Florida Administrative Code Chapter 62-730. Respondent has not issued any permits or licenses to Petitioner. On May 20, 2014, Respondent’s Inspector Dr. Tram Vu inspected Petitioner. The Entry Notice and On-Site Inspection Report was included as an exhibit to the Petition filed in this matter. It makes reference to the “inspection” by Dr. Vu as one, “conducted under Ch. 499.051, F.S., and Rule 61N-1.019, F.A.C., to assess firm’s activities and compliance.” Respondent admitted the May 20th inspection was conducted under the authority cited in the report. On July 16 and 17, 2014, Dr. Vu again inspected Petitioner. A number of photographs were taken during the inspection. The photographs depict two large white containers referred to in the Petition and at the hearing as “yard super sacks.” Inspector Vu testified that the yard super sacks were sealed and that none of the “prescription drugs” photographed were found outside of the sealed Universal Pharmaceutical Waste (UPW) containers. Dr. Vu subsequently requested Petitioner to “voluntarily” quarantine the super sacks and a black tote, and a voluntary quarantine form was prepared and executed. The voluntary quarantine form states that it is “an alternative to the Florida Department of Business and Professional Regulation (‘DBPR’) removing some or all of the products for examination and sampling pursuant to Section 499.065(2), Florida Statutes.” Respondent issued a Notice of Intent to Deny (NOID) to Petitioner on August 18, 2014, regarding its application for a restricted drug distributor/destruction permit. The NOID concluded that Petitioner acted as a restricted drug distributor/destruction establishment without a license. The NOID cited rule 61N-1.023(4), which provides that such a permit is required for a person to take possession in Florida of a prescription drug for the purpose of arranging for its destruction. When asked by Petitioner in an interrogatory, “Are there any facts or circumstances that would cause the DDC to consider that a prescription drug has become UPW and no longer subject to its authority? If so, state or identify each and every such fact or circumstance.” Respondent answered, “No. The term ‘UPW’ is a term that is within the jurisdiction of another Florida state agency, the Department of Environmental Protection (DEP). A prescription drug is no longer a prescription drug when the nature of the prescription drug is altered or changed in a way that the active ingredient which causes the prescription drug to be a prescription drug is no longer active.” Reginald Dixon, the Director of the Division of Drugs, Devices, and Cosmetics (DDC), acknowledged that in his two years as Director, Respondent’s chapter 61N-1 has not contained any definition that addresses the difference between viable drugs and non-viable drugs and that it contains no reference to UPW. Mr. Dixon further acknowledged that chapter 61N-1 does not contain the statement that “[a] prescription drug is no longer a prescription drug when the nature of the prescription drug is altered or changed in a way that the active ingredient which causes the prescription drug to be a prescription drug is no longer active.” He further acknowledged that he is not aware of any federal or Florida law, rule, or regulation that provides the same or similar statement; and that chapter 61N-1 does not contain any definition or explanation as to how the change or alteration that may render the active ingredient inactive takes place. Respondent’s policy that a drug continues to be a prescription drug until its nature is altered or changed so that the active ingredient that makes it a prescription drug is no longer active applies not only to Petitioner. Such policy would apply to other entities engaged in a similar business, as well as to pharmacies, drug wholesalers, and hospitals when considering how to legally dispose of prescription drugs. Respondent takes the position that the UPW rule “is not a rule that belongs to DBPR” (Hr’g Tr. 62); that Respondent “does not have any jurisdiction over the DEP rules” (Hr’g Tr. 75); and that Respondent does “not look at the DEP rules to determine or use their determination of whether or not a drug is viable . . . or nonviable” (Hr’g Tr. 75). “To the extent that [the UPW] rule talks about viable and nonviable pharmaceuticals, that’s not something within our jurisdiction and we don’t deal with it” (Hr’g Tr. 78). Respondent admitted that it is important for regulated entities to know when the agency considered that a drug is no longer under its jurisdiction. Respondent also admitted that if other regulations exist that do not call prescription drugs “prescription drugs” anymore, but instead call them “solid waste, universal pharmaceutical waste or hazardous waste,” those statutes and regulations may “possibly” have a bearing on chapter 499 and chapter 61N-1. In response to Petitioner’s Request for Admissions, Respondent claimed to be “without knowledge” of whether the hazardous waste program under the Federal Resource Conservation Recovery Act (RCRA) established a “cradle to grave” system for controlling hazardous waste; and whether pursuant to 40 C.F.R. § 272.501, the Federal EPA approved the hazardous waste management program administered by the FDEP pursuant to chapter 403, Florida Statutes. Moreover, Respondent was “without knowledge” of whether the U.S. Food and Drug Administration (FDA) does not regulate drugs that have been discarded as hazardous or pharmaceutical waste; and that the FDA does not regulate generators or handlers of hazardous or pharmaceutical waste. Respondent also claimed to be “without knowledge” that some UPW is generated by hospitals during surgical procedures when a vial containing a standard dose of medication is not fully used because of the patient’s size or condition, with the unused dose “wasted” by placing it in a sealed, properly labeled UPW container; that hospitals that dispose of non-controlled and non-viable drugs in a properly labeled UPW container pursuant to rule 62-730.186, do not routinely create a list or inventory of the drugs being wasted or placed in the container that includes the name of the manufacturer, the name of the drug, the quantity, lot number, expiration date, or any combination of these elements; and that hospitals wasting non-viable controlled substances maintain a log that identifies the name and quantity of the controlled substance wasted, but not the manufacturer, the lot number, or the expiration date; and that such controlled substance log complies with DEA regulations as well as chapter 893, Florida Statutes. Mr. Dixon testified that the act of disposing of the unused portion of a prescription drug in a UPW container at a hospital that also contains sharps, broken glass, tissue, and bloody gauzes could constitute the adulteration of that prescription drug. Further, Mr. Dixon testified that when hospitals dispose of drugs in UPW containers they are “possibly” adulterating drugs, and when Petitioner picks up the UPW container, Petitioner may likewise “possibly” be holding adulterated drugs. Petitioner’s witness, Michelle Chambers, was accepted as an expert witness on UPW and related regulations, both state and federal. Although unpaid for her work due to being the spouse of Petitioner’s owner, she is the compliance coordinator, bookkeeper, and registered agent for Petitioner. Mrs. Chambers trains drug wholesalers how to manage their UPW by directing them to “utilize a return if they can get credit for the drug, but that once a drug becomes waste it falls under the guidelines of UPW and those drug wholesalers need to create a separate area that can handle UPW containers.” When discussing the process of sending UPW to a reverse distributor regulated by Respondent, Mrs. Chambers referred to the FDEP’s pharmaceutical waste guidelines, which state: Only pharmaceuticals with a reasonable expectation of credit can be sent to a reverse distributor. Drop pills, non- credible items, formulated mixtures, items with patient’s names, and raw chemicals cannot be sent to a reverse distributor for credit; thereafter, a waste determination is required and the decision must be made to manage this waste as hazardous waste or UPW waste. Mrs. Chambers stated she had knowledge of unexpired drugs, still in the original packaging that were declared waste by the wholesaler. She asserted that drug wholesalers abandoned or discarded the unexpired drugs in their original packaging because “they couldn’t send it back to a reverse distributor to get credit. There was just no value to it, whatsoever, so they decided to make that waste determination that this is waste, UPW.” Mrs. Chambers stated that UPW labels are attached to UPW containers in Petitioner’s facility, according to the FDEP rule regarding UPW. These labels represent the characteristics of the hazardous waste and other waste inside those containers. Some of the notations on the label refer to a substance, material, or a chemical product that is a prescription drug. She also testified that several documents may be created in the UPW process, such as a hazardous-waste manifest and a bill of lading. In records that a UPW handler is expected to maintain under FDEP rules, a UPW handler is not required to have those records contain the name of the drugs that are in the UPW containers, the manufacturer’s information, or the expiration date of the drugs in the UPW container. She asserted that Petitioner could not reasonably create inventories of all the drugs inside a UPW container because “some of the labels have been poured on by other elements within the container; some are unidentifiable; some are broken . . . it would be very difficult to create an inventory.” Based upon her audits of more than 200 hospitals, Mrs. Chambers stated that if a hospital has a procedure to put non-viable drugs in a UPW container, it is because they are trained to do so. She testified that no hospital she has ever audited has ever kept records that include drug names, manufacturers, or expiration dates for anything they have placed in the UPW containers. Petitioner picks up these containers and brings them to its facility. A UPW handler can add waste to the container, as well as consolidate those containers. Mrs. Chambers also discussed consumer packaging under rule 62-730.186(4)(a), which states: “Consumer packaging” means the packaging that surrounds and encloses a container, in a form intended or suitable for a healthcare or retail venue, or rejected during the manufacture process as long as it is enclosed in its bottle, jar, tube, ampoule, or package for final distribution to a healthcare or retail venue. Further, UPW handlers can conduct activities, including disassembling packages containing several pharmaceuticals into individual pharmaceuticals from consumer packaging. In her experience in the auditing of hospitals for UPW, as well as with Petitioner, Mrs. Chambers stated that controlled substances are put into UPW containers from time to time, yet Petitioner has never been cited or received a notice of violation from the DEA regarding the possession of a controlled substance. To her knowledge, the DEA has never notified any UPW handler in Florida of any violations for possessing controlled substances. Dr. Vu conducts inspections and investigations pursuant to chapter 499, specifically investigating unlicensed activities as well as inspecting facilities that are attempting to obtain a DDC permit. Dr. Vu was tendered and accepted as an expert in pharmacy and conducting inspections for Respondent pursuant to chapter 499. She testified that during her inspection of Petitioner on July 14, 2014, she pulled drugs from UPW containers to inspect them. She admitted there were no prescription drugs outside the UPW containers on Petitioner’s premises. She stated that Petitioner’s agents or employees volunteered to open the UPW containers for her inspection. The scant evidence Dr. Vu relied upon that Petitioner had any controlled substances on the premises was based upon documents she obtained from a third party as well as from Petitioner. She admitted there was no evidence of controlled substances on Petitioner’s premises. While Dr. Vu stated she is able to recognize prescription drugs when she sees them, she is not able to recognize UPW since she is “not trained in universal pharmaceutical waste.” She also stated she is not able to recognize a non-viable drug when she sees it. Dr. Vu has received no training from Respondent on the opening of UPW containers, and even though she has not been trained in UPW rules and definitions, she strongly asserted that Petitioner “[c]learly was in possession of prescription drugs,” and that Petitioner had no permit or authorization to possess prescription drugs. When asked about her understanding of when a prescription drug ceases to be a prescription drug, she replied that “a prescription drug is always a prescription drug unless it’s inactivated or loses its drug ability –- characteristics.” Dr. Vu noted that this understanding is not stated in chapter 61N-1 or chapter 499. David Laven, another drug inspector for Respondent, was tendered and accepted as an expert in pharmacy and issues related to the inspection for Respondent under chapter 499. He testified that Petitioner is not allowed to possess prescription drugs without a DDC permit. On cross-examination, however, he admitted he had not read the rule on UPW, has no knowledge of EPA rules and requirements, and that he is not trained to recognize a non-viable drug. He testified that he considers a prescription drug that is discarded in a UPW container still to be a prescription drug because “there’s still a possibility, depending on how that drug has been disposed of, the container may be partially full –- it can be a full container sometimes. Drugs are thrown in a container for a number of reasons, doesn’t necessarily mean that the drug is no longer viable or can be used in any way.” Regarding the definition of prescription drugs, Mr. Laven stated that “[a] drug is no longer viable or useable if it’s out of date, it’s been damaged in some way, compromised, mis-branded, [or] adulterated.” On October 6, 2014, Petitioner sent a Notice of Unadopted Rules letter to Respondent, stating that the conduct and statements set forth above constitute unpromulgated rules and that, according to section 120.595(4)(b), Florida Statutes, they have 30 days to begin proposed rulemaking in order to rectify the actions and statements made. Respondent did not begin proposed rulemaking in that 30-day period. Respondent presented no evidence or testimony to establish that rulemaking was not feasible or practicable.
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.
The Issue Whether the Respondent, Eventide Homes, Inc., should pay a fine of $800.00 for violations of the minimum resident care standards for Adult Congregate Living Facilities set forth in Rule 10A-5.0182, Florida Administrative Code.
Findings Of Fact During the applicable time period, Eventide was licensed to operate as an Adult Congregate Living Facility at the following location: 2869 Sarah Drive, Clearwater, Florida. On April 19, 1988, a licensure renewal survey was conducted by the Department on the premises in order to monitor Eventide's compliance with licensing standards for Adult Congregate Living Facilities. As a result of the survey, citations were issued to the facility for the following deficiencies: Centrally stored medications were not kept in a locked cabinet. Medications were transferred from one storage container to another by someone other than a pharmacist. Unlicensed staff was assisting in the distribution and supervision of self-administered medication in an impermissible manner. The deficiencies were brought to the attention of Dianne Schwartz, President and Administrator of Eventide. It was explained by a representative of the Department that if medisets were used within the facility, a pharmacist was required to complete the transfer of the medications out of their original containers into the medisets. Further, it was explained that unlicensed staff was not allowed to place medication in the mouths of residents. Such staff members could only assist in the opening of medication containers by residents and the placement of the medication into the hands of residents for self- administration. Written verification of the deficiencies was given to the facility administrator, along with a time deadline for correction of the listed deficiencies. The facility was required to correct the deficiencies by the end of April, 1988. On July 12, 1988, the Department representative revisited the facility to determine if the deficiencies had been corrected. The medisets used by the facility were now filled and checked on a weekly basis by Jay Shurline, a pharmacist with Mission Hills Pharmacy. Receipts for the pharmacists's services have been provided as Respondent's Composite Exhibit A. During the July 12, 1988 revisit, unlicensed staff members were observed placing small paper souffle cups containing medications in front of residents so that the residents could administer their own medication. The actual placement of the medications into the souffle cups was completed by the Facility Administrator, a registered nurse. Occasionally, staff members would put the medication on a resident's plate, if this was requested by the resident. Although these new procedures were not as egregious as the prior practices, they were on the same continuum and were contrary to the requirement that residents administer their own medication from the pharmaceutical container into their mouths, without intervention by others. It was explained to the Facility Administrator that the revised procedure for distributing medications was still a deficiency in that medications were still being transferred from one storage container (medisets) to another (souffle cups) by someone other than a pharmacist (Facility Administrator). In addition, the revised procedure regarding the supervision of self-administered medication by residents still failed to comply with the standards for supervision. The medications were removed from the control of residents in an unnecessary procedure. Residents in this type of health care facility are able to administer their own medication unless their physician indicates otherwise. In those instances, a licensed staff member must administer the medication. These ongoing deficiencies were to be corrected immediately. The facility was revisited on October 26, 1988. During this visit, the Department representative was informed by a staff person of revised procedures used for the supervision of medication. These procedures, as explained by the staff member, were found to be unsatisfactory by the Department's representative. The revised procedures discovered by the Department on October 26, 1988, were presented at hearing in the form of impermissible hearsay. The Facility Administrator denied the allegations and explained that small, empty cups were placed by each resident's dinner plate for their personal use. A resident may use the cup for water to assist in the swallowing of medication or to pour his or her own medication. For example, one resident suffers from palsy and finds it easier to take all of his medications at one time. The small cup is used by him to carry medications from his hands to his mouth. No mistakes regarding the accuracy of dosages or the use of medications occurred during Eventide's distribution and supervision of self- administered medication in an impermissible manner.
Recommendation Based upon the foregoing, it is RECOMMENDED: That the Respondent be found guilty of having violated Rule 10A- 5.0182(3)(a)4, Florida Administrative Code, as alleged in Paragraph (3)(a) of Count I of the Administrative Complaint. That the Respondent be found guilty of having violated Rule 10A- 5.0182(3)(a)6b, Florida Administrative Code, as alleged in Paragraph (3)(b) of Count I of the Administrative Complaint. That the Respondent be found guilty of having violated Rule 10A- 5.0182(3)(b)2, Florida Administrative Code, as alleged in Paragraph (3)(c) of Count I of the Administrative Complaint. That the Respondent be found not guilty of having violated Rule 10A- 5.0182(3)(b), Florida Administrative Code, as set forth in Paragraph (4)(a) of Count II of the Administrative Complaint. That the civil penalty assessed against the Facility Administrator for each violation be limited to the minimum which can be assessed under Section 400.419(3)(c), Florida Statutes, which results in a total fine of $300.00. DONE AND ENTERED this 20th day of July, 1989, in Tallahassee, Leon County, Florida. VERONICA E. DONNELLY 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 20th day of July, 1989. APPENDIX TO RECOMMENDED ORDER CASE NO. 88-2238 Petitioner's proposed findings of fact are addressed as follows: Accepted. See HO #2. Accepted. See HO #3 and #4. Rejected. Contrary to fact. See HO #6. Accepted. See HO #10. Accepted. See Preliminary Statement. Accept the first sentence. See HO #3 and #8. The rest of paragraph 6 is improper summary and argument. Attempts to shift burdens of proof to Respondent. Accept that Department representative observed improper procedures on April 19 and July 12. See HO #3, and #8. Reject as to October 26. See HO #10 and #11. Proposed findings outside the scope of the allegations set forth in the Administrative Complaint are rejected on that basis. Respondent's Proposed Findings of Fact are addressed as follows: Accepted. See Preliminary statement. Accepted. See HO #3 and #7. Reject first sentence. See HO #3 and #8. Reject second sentence. See HO #8. Accept third sentence. See HO #12. COPIES FURNISHED: Edward A. Haman, Esquire Office of Licensure and Certification Department of Health and Rehabilitative Services 7827 North Dale Mabry Highway Tampa, Florida 33614 James Schwartz, Esquire 416 Drew Street Clearwater, Florida 34615 Gregory L. Coler, Secretary Department of Health and Rehabilitative Services 1323 Winewood Boulevard Tallahassee, Florida 32399-0700 R. S. Power, Esquire Agency Clerk Department of Health and Rehabilitative Services 1323 Winewood Boulevard Building One, Room 407 Tallahassee, Florida 32399-0700
The Issue The issues to be decided are whether Respondent violated portions of chapter 458, Florida Statutes, as alleged in the Administrative Complaints; and, if so, what penalty should be imposed.
Findings Of Fact Petitioner is the state agency charged with regulating the practice of medicine pursuant to section 20.43 and chapters 456 and 458, Florida Statutes. At all times material to this matter, Dr. Mubang was a licensed physician within the State of Florida, having been issued license number ME55171. Respondent’s address of record is 741 Martin Luther King Boulevard West, Seffner, Florida 33584. Since at least March 17, 2010, Dr. Mubang’s practice at 741 Martin Luther King Boulevard has been registered as a pain management clinic with Petitioner. Dr. Mubang is board-certified in geriatric medicine and ambulatory medicine. Dr. Mubang immigrated to the United States from Cameroon, West Africa, to obtain his college education at State University of New York-Buffalo (“SUNY-Buffalo”). Dr. Mubang received a bachelor of arts degree in biology from SUNY-Buffalo. Dr. Mubang attended medical school at Southwestern University School of Medicine in the Philippines. Upon completion of his medical education, Dr. Mubang attended the Medical College of Pennsylvania for clinical rotations. He performed his residency at State University of New York-Brooklyn and Hahnemann University. Dr. Mubang’s license was first issued June 14, 1989, and is valid through January 31, 2020. His license has not been the subject of prior discipline. Dr. Mubang has maintained his Drug Enforcement Agency (“DEA”) Certificate of Registration without revocation, suspension, or other sanction. He has additionally qualified for, and obtained, a separate DEA Certificate of Registration to dispense Suboxone and buprenorphine. This secondary DEA Certificate of Registration requires training in addiction medicine. Dr. Mubang has continuously practiced as the primary care physician for many of his patients. He began his practice in Florida with CIGNA Health Group in one of its managed care clinics at University Mall in Tampa. When CIGNA closed its clinics, Dr. Mubang became employed by Correctional Medical Services (“CMS”), initially at Lake Correctional Facility, and then as the medical director for the Hillsborough County Sheriff’s Office. During his tenure with the Hillsborough County Sheriff’s Office, Dr. Mubang was recognized as the “Medical Director of the Year” for CMS in 1998. After leaving the Hillsborough County Sheriff’s Office, Dr. Mubang joined a practice with Dr. Encarnacion in Seffner, Florida. When Dr. Encarnacion retired, Dr. Mubang acquired the practice. In May 2009, Dr. Mubang received from the Board of Medicine and the Department of Health a publication entitled, “responsible opioid prescribing.” Dr. Mubang learned through his participation in various continuing medical education seminars about certain forms recommended for the treatment of patients suffering from chronic pain. He did not use electronic medical records prior to the dates of treatment charged in these consolidated Administrative Complaints. While in private practice, Dr. Mubang continued to treat patients committed to the State of Florida Juvenile Assessment Centers in Pasco, Pinellas, Sarasota, and Manatee counties. Dr. Mubang’s practice was licensed as a pain management clinic in 2010, despite his having limited formal training or education in pain management. Since initial licensure, his pain management clinic has remained continuously in operation, and has consistently passed all inspections. Pain Management Clinics are subject to annual inspections by DOH pursuant to section 458.3265(4)(a). Dr. Mubang’s Pain Management Clinic has never failed an inspection. DOH Investigator Victor Troupe of the Investigative Services Unit performed inspections of Dr. Mubang’s clinic. The clinic passed inspection. Dr. Mubang’s charged treatment of Patients A.M., B.B., C.C., W.B., and M.H., as alleged in the Administrative Complaint, occurred prior to October 17, 2010, the effective date of revised rule 64B8-9.013. Both parties presented expert witnesses board-certified in pain management to testify as to the standard of care required in this matter. Dr. Robert Guskiewicz testified as a medical expert for Petitioner. Dr. Guskiewicz is board-certified by the American Board of Anesthesiology in anesthesiology with a subspecialty in pain medicine. Dr. Guskiewicz practices as part of a large multispecialty practice in Gainesville, Florida, called Southeast Integrated Medical (“SIMED”). SIMED’s practice areas include neurology, neurosurgery, rheumatology, gynecology, psychology, urology, physiatry, allergy, family practice, and internal medicine. Dr. Guskiewicz is not now, and never has been, a primary care physician. About 40 percent of Dr. Guskiewicz’s practice is performing injections or interventions on patients. Most of the balance is patients on medication management seeking to achieve better functionality. Dr. Guskiewicz defines the standard of care as “what a prudent physician would do with a particular patient in a particular situation at that particular time.” In his practice, Dr. Guskiewicz prescribes 30 mg of oxycodone. Oxycodone is an effective pain medication. According to him, there is no maximum recommended dose for 30 mg of oxycodone. For the purposes of his expert testimony, Dr. Guskiewicz has no knowledge or information regarding Dr. Mubang or his practice. He does not know how big the clinic is where Dr. Mubang practices, who owns it, how many patients are seen each day, how many employees work there, or the types of patients treated there. Dr. Guskiewicz was paid an hourly fee for his expert testimony and preparation for deposition in this matter. Dr. Guskiewicz testified that he did a page-by-page review of the medical records he initially reviewed and those provided for his deposition in lieu of live testimony. Dr. Guskiewicz testified that the records were identical for Patients A.M., B.B., W.B., and M.H., but that the Bates numbers for the records for Patients C.C. and B.D. were not in sync. For Patient B.B., it was apparent at the hearing that Dr. Guskiewicz was in possession of the requisite records, which Respondent argued, had not been reviewed. For Patient M.H., Dr. Mubang argued that Joint Exhibit 6, covering records of treatment from 2010-2012, was not reviewed by Dr. Guskiewicz. Dr. Guskiewicz testified that the records for Patient M.H. were identical. In any event, the records subject to Respondent’s objection concern treatment after the treatment dates at issue in the Administrative Complaint. Only the records concerning the allegations contained in the Administrative Complaints will be considered for purposes of this Recommended Order. Dr. Mubang also raised the issue that Dr. Guskiewicz was not a similarly situated practitioner to Respondent. Dr. Mubang self-identified as practicing in pain management, and he owned and operated a clinic that was registered as a pain management clinic with DOH. Each patient treated by Dr. Mubang signed an Attestation for Pain Management, along with an Agreement for Treatment with Controlled Substances Therapy for Pain. Dr. Mubang acknowledged that if he gave a patient a pain management agreement, he was providing pain management to that patient. If a health care provider is providing evaluation, treatment, or diagnosis for a condition that is not within his or her specialty, a specialist trained in the evaluation, treatment, or diagnosis for that condition shall be considered a similar health care provider, pursuant to section 766.102(8), Florida Statutes. Because Respondent’s care at issue in this case is pain management, which is not specifically within his specialty, Dr. Guskiewicz is considered a similarly situated practitioner to Respondent. Petitioner did not provide Dr. Guskiewicz with any deposition testimony in this action until after his deposition in lieu of live testimony on October 9, 2018. Consequently, the depositions were not considered at the time Dr. Guskiewicz prepared his reports in this action. Dr. Guskiewicz never interviewed any of the patients at issue in this matter; never conducted any physical examination of the patients; and does not know where any of these patients are today. Further, he does not know what their current condition is; whether any of the patients are still receiving treatment for chronic pain; and whether any of the patients are still receiving opioid pain medications for the treatment of chronic pain. During the time periods relevant to these consolidated actions, Florida did not have a prescription drug monitoring database or E-FORCSE. At the time Dr. Guskiewicz authored his November 29, 2011, report, there was not a prescription drug monitoring database in Florida to permit practitioners to verify a patient’s representations about the medications they were taking and who had prescribed them. Dr. Guskiewicz is not a primary care physician, and has never been called upon to cover for a primary care physician who is treating a patient and has an ongoing relationship with that patient. Dr. Guskiewicz agrees that physicians in Florida have an obligation to consider their patients’ subjective complaints of pain and to treat them. Dr. Guskiewicz defines pain management as “treating patients who have chronic pain and provide different modalities of care to increase the functionality and well-being within that patient.” The goal of pain management is to optimize the patient’s functionality, lifestyle, and well-being within his or her family and community. Dr. Guskiewicz acknowledged that a patient coming to him for medical management of his or her pain is looking for an increase in function so he or she can get back to work and participate in normal activities of daily living. Dr. Guskiewicz defines intractable pain as “pain that perpetuates itself no matter what modalities are tried and will always be there. It’s now thought of being a more centralized pain that is basically within the brain itself.” Dr. Thomas Simopoulos testified as a medical expert for Respondent. Dr. Simopoulos is board-certified by the American Board of Anesthesiology in anesthesiology with a subspecialty in pain medicine. Dr. Simopoulos testifies as an expert for the defense more than 90 percent of the time. In the last five years, Respondent’s counsel has paid Dr. Simopoulos $30,000 to $50,000 in expert witness fees. Dr. Simopoulos lives in and practices medicine in Massachusetts. Dr. Simopoulos is not licensed to practice medicine in any other state; and he has never practiced medicine in the State of Florida. Dr. Simopoulos testified that the standard of care at the time material to this case was more regional than national. Dr. Simopoulos educated himself about the regional standard of care in Florida through conversations with his students and through hearing from people at national meetings. Dr. Simopoulos testified that patients have the right to reject a surgical recommendation: “Patients who are younger, in their more productive years, may not want to seek out surgery as a solution, particularly of the spine because it usually means that they’re at risk for having multiple surgeries. So and that even continues today, we try to manage younger folks with more conservative measure [sic], including medications to try to avoid surgery, because we know where that trajectory is going to go.” Dr. Simopoulos admitted that there were no studies at the time material to this case that revealed the exact nature and course of practice in the State of Florida. While Dr. Simopoulos is credited as an expert in anesthesiology and pain management, his reliance on the second- hand accounts from students and conferences he attended to form his opinions about the regional standard of care in Florida, are not as persuasive as the accounts of Dr. Guskiewicz, a physician practicing in the area of anesthesiology and pain management in Florida. Accordingly, Dr. Guskiewicz’s testimony is entitled to greater weight in this proceeding. Dr. Simopoulos also opined that the standard of care can only be violated when a patient is harmed. DOH argued that his definition is inconsistent with the definition in Florida law as contained in section 766.102(1). DOH Investigator Victor Troupe served a subpoena on September 2, 2010, for patient records to include: A.M., B.B., C.C., M.H., and W.B. Investigator Troupe took possession of the original files on that date. He has no reason to believe those patient files had been altered in any way. Investigator Troupe had performed numerous annual inspections of Dr. Mubang’s clinic, and neither found any violations or issued any citations. Investigator Troupe never interviewed Patients A.M., B.B., C.C., M.H., W.B., or B.D. Further, Investigator Troupe has no knowledge or information regarding the present whereabouts of any of those individuals. Finally, he has no information about whether those patients are still receiving opioid analgesic pain medication, even though DOH has access to E-FORCSE for investigative purposes. Drug Definitions Oxycodone is commonly prescribed to treat pain. Roxicodone is a brand name for oxycodone. Oxycodone is a Schedule II controlled substance. Oxycodone will be used throughout this Order, even if the brand name Roxicodone was prescribed. All Schedule II controlled substances have a high potential for abuse and have currently accepted, but severely restricted, medical use in treatment in the United States. Abuse of Schedule II controlled substances may lead to severe psychological or physical dependence. § 893.03(2), Fla. Stat. Fentanyl is a very strong opioid that is prescribed to treat pain and is listed as a Schedule II controlled substance. § 893.03(2)(b), Fla. Stat. Hydromorphone is a Schedule II controlled substance that is commonly prescribed to treat pain. Hydromorphone is commonly prescribed under the brand name Dilaudid. § 893.03(2)(a), Fla. Stat. Methadone is a synthetic opioid prescribed to treat pain. Methadone is a Schedule II controlled substance. § 893.03(2)(b), Fla. Stat. Vicodin and Lortab are brand names for hydrocodone/APAP. Hydrocodone/APAP contains hydrocodone and acetaminophen and is prescribed to treat pain. Hydrocodone in the dosages found in Vicodin is a Schedule III controlled substance. § 893.03(3)(c)4., Fla. Stat. All Schedule III controlled substances have a potential for abuse less than the substances in Schedules I and II. Abuse of Schedule III controlled substances may lead to moderate or low physical dependence or high psychological dependence. § 893.03(3), Fla. Stat. Fiorinal with codeine is the brand name for a drug that contains butalbital and codeine and is commonly prescribed to treat migraine headaches. Butalbital is a Schedule III controlled substance. Codeine is commonly prescribed to treat pain. Codeine is a Schedule II controlled substance. § 893.03(3)(a) and (2)(a), Fla. Stat. Ultram is a brand name for tramadol, an opioid-class narcotic medication prescribed to treat pain. At the time of the events of this case, tramadol was not a controlled substance. Tramadol is currently a Schedule IV controlled substance. § 893.03(4)(b), Fla. Stat. (2018). All Schedule IV controlled substances have a low potential for abuse relative to the substances in Schedule III. Abuse of Schedule IV controlled substances may lead to limited physical or psychological dependence relative to the substances in Schedule III. § 893.03(4), Fla. Stat. Soma is the brand name for carisoprodol. Carisoprodol is a muscle relaxant commonly prescribed to treat muscular pain. Carisoprodol is a Schedule IV controlled substance. § 893.03(4), Fla. Stat. Adderall is the brand name for a drug that contains amphetamine. Adderall is commonly prescribed to treat attention deficit disorder (“ADD”). Adderall is a Schedule II controlled substance. § 893.03(2)(c), Fla. Stat. Xanax is the brand name for alprazolam. Klonopin is the brand name for clonazepam. Valium is the brand name for diazepam. All three drugs are benzodiazepine-class drugs prescribed to treat anxiety, and all three drugs are Schedule IV controlled substances. During the time Respondent treated the five patients, who are the subject of the DOH Case No. 2010-12384, Florida did not have a prescription drug monitoring database. Before E-FORCSE, practitioners had to rely upon a patient’s representation regarding his or her medication history and verify the information by calling identified pharmacies. This “trust but verify” policy was in place at Dr. Mubang’s practice. During the time of Dr. Mubang’s treatment of these patients, he received a letter from Ana M. Viamonte Ros, M.D., the surgeon general for the State of Florida, and Fred Bearison, M.D., the chairman of the Florida Board of Medicine, dated May 13, 2009. That letter enclosed a copy of Responsible Opioid Prescribing, A Physician’s Guide, written by Scott M. Fishman, M.D. The letter advised Dr. Mubang, and others similarly situated, that Dr. Fishman’s book “is a practical guide to Florida’s current standards for the use of controlled substances for the treatment of pain,” based upon the Federation of State Medical Board’s Model Rule, “so it is right on point for Florida practicing doctors.” The book also stated, at page 25: Although Medicare and other institutions have defined what constitutes a physical examination for purposes of coding and reimbursement, exactly what comprises an appropriate or acceptable physical examination for pain is not well-defined, largely because it will differ from case to case. Regulators who expect to see a physical examination as part of the evaluation that leads to appropriate pain care involving controlled substances assume that a basic, if not focused, examination is warranted. The exact components of the examination are left to the judgment of the clinician who is expected to have performed an examination proportionate to the diagnosis that justifies a treatment. Dr. Mubang testified at the hearing, “many point-of- care screens for ‘opiates’ do not reliably detect any opioid other than codeine and morphine, or may not report if levels are below a certain threshold. Therefore, they may give false negative results for semisynthetic and synthetic oil opioid analgesics.” Dr. Mubang received feedback from pharmacists and patients regarding limitations on prescribing imposed on distributors and pharmacies by the DEA, including during the fall of 2010. During the time Dr. Mubang treated the six patients subject to these consolidated administrative actions, there was no upper limit recommended or identified regarding the maximum dosage for opioid analgesics. New patients to Dr. Mubang’s practice have to fill out paperwork, including a patient history. Patients were also required to sign an opioid contract, which mandated patients to use only one pharmacy and required that the patient only obtain medication from Dr. Mubang. Dr. Mubang obtained authorizations for release of medical information to acquire records of prior treating physicians. His office consistently obtained prior records, including MRIs and other diagnostic studies. Dr. Mubang testified that he performed a physical examination of each patient on each office visit. The initial exam was broad, while follow-up examinations were focal. His physical examinations included a review of systems, from head to toe. He stated that each physical examination included a review of the patient’s neurological status and notes whether the patient is oriented to person, time, and place. Dr. Mubang’s practice was to observe patients in his waiting room, and watch each patient as they come to the exam room. This observation is intended to identify things like gait abnormalities, guarding, and posture. Pain patients in Dr. Mubang’s practice are required to complete a Brief Pain Inventory, which he reviews with each patient. Dr. Mubang also reviews past medications with each patient to determine whether the medication has been effective in relieving pain and increasing activities of daily living. He reviews with each patient potential side effects of medication and the risks and benefits of using those medications. Dr. Mubang prepares a progress note for each office visit with a patient. Additionally, he maintains copies of each prescription issued to a patient. The identified treatment plan for each of these six patients was to improve the patient’s functional abilities, to allow them to return to work, and to participate in relationships. Dr. Mubang periodically required patients to submit to a urine immunoassay. This is a presumptive screening test for illicit substances and some other controlled substances. As Dr. Fishman points out on page 61 in his book Responsible Opioid Prescribing, Dr. Mubang was aware that “point-of-care screens for opioids do not reliably detect any opiate other than codeine and morphine.” During the 2010 timeframe, a physician who ordered a urine drug screen was not required to do anything with the results. Further, the requirements of rule 64B8-9.013(3)(d) to monitor patient compliance were not mandatory until after October 17, 2010. Dr. Mubang is aware of the sedative effects of opioids taken with muscle relaxants like Soma. This combination of medication should be dispensed with caution, but if a patient has been taking it for a period of time with no problems, he believes the prescription is appropriate. Dr. Mubang’s approach to changing pain medication, as explored more fully in the following discussion of the six patients subject to this proceeding is consistent, but deserves close scrutiny. He testified that: If the vital signs are stable, you can do what you want, so long as it doesn't have consequences. If you see the visit after this, this patient did not come in with hypertension or they did not end up in the hospital or I was not called at 2:00 in the morning. So it tells you what you're doing is right. See? That's why we do these vital signs. The Patients Each of the patients in this cause completed a two-page questionnaire about his or her pain, titled “brief pain inventory,” during each visit after the initial visit. The pain inventory contained: an anatomical figure for the patient to mark painful areas, 12 questions with a one-to-ten scale for pain level and for activities of daily living, and spaces for the patient to describe the pain in writing. Dr. Mubang’s progress notes for each of the patients consisted of a printed form, containing a similar anatomical figure at the top of the page with most of the rest of the page containing a checklist for “assessment.” Patient A.M. From December 22, 2009, to October 20, 2010, Dr. Mubang provided pain management treatment to Patient A.M., a then 23-year-old female, for lower back pain related to a car accident that occurred several years earlier. Dr. Mubang had first begun treating Patient A.M. while covering for Dr. Luis Azan at Plant City Polyclinic, where he prescribed her 240 30 mg tablets of oxycodone and 120 10 mg tablets of methadone. Dr. Mubang noted that Patient A.M. had been a passenger in the back of the car and was wearing a seatbelt. He noted that Patient A.M. did not lose consciousness, and while she went to the emergency room, she did not have an in-patient stay. On her initial evaluation questionnaire, Patient A.M. reported trying four alternative treatment methods for her pain out of 18 possible treatment options on Dr. Mubang’s checklist form: chiropractic treatment (no relief); muscle injections (no relief); massage (no relief); and pain relievers (some relief). By her own report, Patient A.M. had not tried physical therapy, nerve blocks, or surgery. Patient A.M. had sequential MRI findings from November 7, 2007 (ordered by Dr. Murthy Ravipati), and March 23, 2010 (ordered by Dr. Mubang), which demonstrated a central focal disc protrusion (herniated nucleus pulposus) at L5-S1. On her first visit at his office, Dr. Mubang increased Patient A.M.’s oxycodone from 240 to 270 30 mg tablets per month. He failed to document a rationale for the 30-pill increase. Dr. Mubang’s medical records included Patient A.M.’s medical history and physical examination; diagnostic, therapeutic, and laboratory results; evaluations and consultations; objectives identified; risks and benefits of the treatment ordered; treatments and medications ordered and documented; and instructions and agreements regarding pain management. Dr. Mubang made referrals to consulting physicians, including Dr. Goldsmith (orthopedic) and physical therapy (Select Physical Therapy). From December 22, 2009, to August 27, 2010, Dr. Mubang prescribed 270 30 mg tablets of oxycodone in combination with 120 10 mg tablets of methadone to Patient A.M. monthly. In ten months, Patient A.M. received 3,870 pain pills from Dr. Mubang. In order to take the pain medication as prescribed, Patient A.M. would have to take 13 pain pills per day. By comparison, Dr. Mubang’s expert, Dr. Simopoulos, testified that in his practice the most 30 mg of oxycodone that he ever prescribed was six tablets per day, or 180-200 tablets per month. Petitioner’s expert, Dr. Guskiewicz, testified that in his practice the most 30 mg of oxycodone that he ever prescribed was five per day, or 150 tablets. In addition to the pain medication, Dr. Mubang prescribed 90 350 mg tablets of Soma to Patient A.M. per month. On August 2, 2010, Dr. Mubang ordered a urine drug screen for Patient A.M. The drug screen was positive for benzodiazepines and negative for methadone. If a patient tests negative for a prescribed medication, the physician should consider the possibility that the patient is not taking the drug and, instead, is diverting it. Given Patient A.M.’s negative test for methadone, Dr. Mubang should not have continued to prescribe methadone to her, or at least should have questioned her about her usage of the prescribed drug. Despite the aberrant test result, Dr. Mubang continued to prescribe potentially lethal doses of oxycodone, methadone, and Soma to Patient A.M. Further, from December 22, 2009, through August 27, 2010, Dr. Mubang did not perform nor did he document performing a complete and adequate physical examination or medical history to justify his prescribing of potentially lethal doses of methadone, oxycodone, and Soma to Patient A.M. From December 22, 2009, through August 27, 2010, Dr. Mubang did not diagnose Patient A.M. with intractable pain prior to prescribing potentially lethal doses of methadone, oxycodone, and Soma to Patient A.M. To meet the standard of care, Dr. Mubang should have immediately reduced the amount of medication that he prescribed to Patient A.M. Additionally, he should have tried to determine the root cause of Patient A.M.’s pain. Dr. Mubang should have followed up on his ordering of alternative treatment modalities, such as physical therapy, and if Patient A.M. refused to follow his instructions, he should have discharged Patient A.M. While Dr. Mubang’s records are at times difficult to read, some were legible enough for review by the two experts who offered opinions in this matter. On the whole, however, the medical records for Patient A.M. were inadequate (and some of them were actually illegible) to provide complete information to either Dr. Mubang or another reviewing physician or investigator. Patient B.B. From March 25, 2010, to August 23, 2010, Respondent provided pain management treatment to Patient B.B., a then 25- year-old female. Patient B.B. initially visited Dr. Mubang on March 25, 2010, with a history of cervical spinal fusion in 2003 following a motor vehicle accident. Dr. Mubang’s Initial Evaluation documented a thorough review of systems, including skin; HEENT (head, eyes, ears, nose, and throat); neurological; and musculoskeletal. Simultaneously, Dr. Mubang and the patient completed a Pain Questionnaire documenting the location and severity of Patient B.B.’s pain and other treatment modalities, which had been tried, but failed (surgery, braces, chiropractic, physical therapy, TENS, and massage). On her initial visit with Dr. Mubang, Patient B.B. reported having neck, shoulder, and upper back pain. Dr. Mubang noted on his initial range of motion assessment that Patient B.B. had no thoraco-lumbar spine pain. Patient B.B. never indicated on her brief pain inventories that she had pain radiating down the leg. Instead, she consistently marked pain in the neck, radiating down the right arm, and pain in the middle back. After the initial visit, Dr. Mubang recorded that Patient B.B. had lower back pain by noting “LBP & radiculopathy” with a line drawn down the leg of the anatomical figure. Dr. Mubang’s explanation for the discrepancy between his notation on the anatomical figure and Patient B.B.’s notation was that the patient was noting pain, but that he was noting tenderness. He did not explain the difference. As discussed below, this same inconsistency appears frequently in many of the patients’ records. Dr. Mubang’s offered explanation for the discrepancy between his records and the patient-generated records is not credible. From March 25, 2010, to August 23, 2010, Dr. Mubang prescribed 240 30 mg tablets of oxycodone in combination with 60 2 mg tablets of Xanax to Patient B.B. monthly. From March 25, 2010, to May 20, 2010, Dr. Mubang also prescribed 120 350 mg tablets of Soma to Patient B.B., in addition to the oxycodone and Xanax each month. To justify the amount of Xanax he prescribed to Patient B.B., Dr. Mubang relied on an anxiety checklist questionnaire completed by Patient B.B. In his practice, if a patient marked five to six of the criteria on his anxiety checklist, Dr. Mubang would prescribe the patient Xanax. For Patient B.B., on three of his five progress notes, Dr. Mubang checked the box for anxiety. Other than that, there is no annotation or documentation by Dr. Mubang concerning Patient B.B.’s anxiety. From March 25, 2010, through August 23, 2010, based on Patient B.B.’s history and physical findings, Dr. Mubang prescribed potentially lethal doses of oxycodone, Xanax, and Soma to Patient B.B. in excessive quantities and without sufficient justification. From March 25, 2010, through August 23, 2010, Dr. Mubang neither performed nor documented performing a complete and adequate physical examination or medical history to justify his prescribing of potentially lethal doses of oxycodone, Xanax, and Soma to Patient B.B. From March 25, 2010, through August 23, 2010, Dr. Mubang failed to diagnose Patient B.B. with an anxiety disorder, which would have supported his prescribing of Xanax to Patient B.B. From March 25, 2010, through August 23, 2010, Dr. Mubang did not diagnose Patient B.B. with intractable pain prior to prescribing potentially lethal doses of oxycodone, Xanax, and Soma to Patient B.B. To meet the standard of care, Dr. Mubang should have done more to treat Patient B.B.’s underlying source of pain through referrals for physical therapy or orthopedics. Depending on the particular findings, he should have tried intervention care to relieve Patient B.B.’s pain instead of relying solely on medication management, particularly, excessive amounts of oxycodone. Patient B.B., as a relatively young patient, would have benefited from more aggressive physical therapy, massage therapy, and other treatment modalities to keep her off of addictive pain medication as much as possible. Dr. Mubang attempted, in part, to justify his excessive amounts of medications, based upon The Super Saver pharmacy profile for Patient B.B., which confirms that this patient was receiving the same quantities and combination of medications from the prior physician, Ibem R. Borges, M.D. He also cites rule 64B8-9.013 (2003) to support the heavy prescribing of medications, which indicates the Board of Medicine will not judge the validity of prescribing, “based upon the quantity and chronicity,” and that a “physician’s conduct will be evaluated to a great extent by treatment outcome.” He argues that Petitioner failed to introduce any evidence to establish Patient B.B. suffered any adverse effect from Dr. Mubang’s treatment. Patient C.C. From April 29, 2010, to May 28, 2012, Dr. Mubang provided pain management treatment to Patient C.C., a then 32-year-old female. At her initial evaluation, Patient C.C. reported having lower back pain and left knee pain. On her subsequent brief pain inventories, Patient C.C. consistently marked pain at the middle of the lower back and pain at the left knee. Almost identical to Patient B.B., Dr. Mubang’s progress notes for Patient C.C. note “LBP & radiculopathy” with a line drawn down the leg of an anatomical figure indicating pain radiating down the leg. Contained in Respondent’s records were notes from two prior treating providers, Drs. David Herson and Marc Weinstein. On a note dated February 27, 2007, Dr. Herson noted that Patient C.C.’s cervical and lumbar range of motion was within normal limits, and he noted no tenderness to palpation of the lumbar spine. Dr. Herson recommended epidural injections to Patient C.C. for the left knee pain. Dr. Herson prescribed Patient C.C. 30 tablets of Ultram for her pain. On a note dated March 1, 2007, Dr. Weinstein noted that “MRI scans of her cervical and lumbar spine and left knee were performed and show no significant abnormalities that would require surgery.” From April 29, 2010, to August 19, 2010, Dr. Mubang prescribed 290 30 mg tablets of oxycodone in combination with 180 10 mg tablets of methadone to Patient C.C. monthly. In a period of four months, Patient C.C. received 2,350 pain pills from Dr. Mubang, which equates to a daily prescription of 15.5 pills. In addition to addictive pain medication, Dr. Mubang also prescribed 60 2 mg tablets of Xanax to Patient C.C. per month. Opioids and benzodiazepines in combination increase the risk of respiratory depression, which can be fatal. On April 29, 2010, and May 27, 2010, Dr. Mubang added 90 350 mg tablets of Soma to the potentially lethal cocktail of medications he prescribed to Patient C.C. Dr. Mubang failed to document his rationale for starting and stopping Soma. On April 29, 2010, as part of her initial evaluation with Dr. Mubang, Patient C.C. reported to him that her current medications were oxycodone, methadone, Xanax, and Soma. On April 29, 2010, Dr. Mubang ordered a urine drug screen for Patient C.C. The drug screen was positive for opiates, oxycodone, and benzodiazepines, but was negative for methadone. Opiates and opioids are discernibly different categories of drugs. Opiates are morphine derivatives. Opioids are synthetic opiates. No medications Patient C.C. reported taking were opiates. The standard of care required Dr. Mubang to inquire as to the reasons behind the aberrant drug test result and adjust Patient C.C.’s medications accordingly. In his 2012 deposition, Dr. Mubang speculated that he may have consulted Patient C.C. about the drug test and that maybe she ran out of medication. He could not tell from his records if he discussed the results with Patient C.C. or the reason for the aberrant test result because his records lacked any such information. At the final hearing in this matter, Dr. Mubang raised for the first time the defense that the urine drug screen he used at that time was incapable of testing for methadone. He also argued that if a patient is taking oxycodone and methadone together, then either one, both, or neither may show up positive on a urine drug screen due to “tolerance” and methadone’s interaction with oxycodone and with the NMDA (the amino acid neuro receptor that increases the tolerance of oxycodone by interacting with methadone). This was a clear misunderstanding by Dr. Mubang of his expert’s testimony regarding the use of methadone in pain management. Dr. Mubang testified many times at hearing that methadone has a tolerance effect on oxycodone, which causes a physician to increase the dose of oxycodone. Respondent’s testimony was incongruent with the description given by his expert witness. Dr. Simopoulos explained that methadone can antagonize NMDA receptors, which can help some patients who have a tolerance to oxycodone. However, Dr. Simopoulos’s testimony regarding NMDA did not relate to the ability to detect methadone in a urine drug screen. Despite the negative test result for methadone, during the same visit, Dr. Mubang prescribed 180 10 mg tablets of methadone to Patient C.C. No questions of whether Patient C.C. may have diverted her methadone or notations of such were in the doctor’s notes. Dr. Mubang failed to order a second urine drug screen for Patient C.C. until ten months later on February 2, 2011. The second test was also negative for the prescribed medication methadone. From April 29, 2010, through August 19, 2010, based on Patient C.C.’s presentation, Dr. Mubang prescribed potentially lethal doses of oxycodone, methadone, Xanax, and Soma to Patient C.C. inappropriately, in excessive quantities, and without justification. From April 29, 2010, through August 19, 2010, Dr. Mubang neither performed nor documented performing a complete and adequate physical examination or medical history to justify his prescribing potentially lethal doses of oxycodone, methadone, Xanax, and Soma to Patient C.C. Dr. Mubang did not diagnose Patient C.C. with intractable pain prior to prescribing to the patient the potentially lethal doses of oxycodone, methadone, Xanax, and Soma. To meet the standard of care, Dr. Mubang should not have prescribed such large amounts of pain medication to Patient C.C., a patient who did not have a significant pathology for pain. Instead, he should have pursued other treatment modalities, such as injections and physical therapy. Patient W.B. From December 13, 2008, to February 18, 2011, Dr. Mubang provided pain management treatment to Patient W.B., a then 52-year-old male. On or about April 20, 2008, prior to visiting Dr. Mubang, Patient W.B. presented to the emergency room at Sarasota Memorial Hospital after being hit by a “slow moving vehicle,” while riding his bicycle. The emergency room physician diagnosed Patient W.B. with a bruise of the left knee and left hip and prescribed an unknown quantity of 7.5 mg Lortab to Patient W.B. Patient W.B. then visited Physician’s Group, LLC, in Sarasota for follow-up care on April 20, May 28, November 11, and December 2, 2008. On May 28, 2008, Patient W.B. reported to a provider at Physician’s Group, LLC, that he had taken Dilaudid from a friend. On November 11, 2008, Patient W.B. saw Dr. Frederic Sonstein. Dr. Sonstein noted that Patient W.B. missed a scheduled appointment because he was incarcerated. While incarcerated, Patient W.B. was treated with Flexeril and Ultram. Dr. Sonstein recommended referral to a pain management specialist and prescribed Vicodin for pain control. A November 24, 2008, MRI report of Patient W.B.’s lumbar spine was unremarkable. On December 13, 2008, Patient W.B. came to Dr. Mubang and reported having pain in his neck and shoulders, with pain radiating down both arms. In contrast to Patient W.B.’s report, on his initial range of motion evaluation, Dr. Mubang did not document any findings under cervical spine. Instead, he noted lumbar spine pain with radiculopathy. On his initial evaluation questionnaire, Patient W.B. reported only having tried one alternative treatment method for his pain, “braces or cast.” By his own report, Patient W.B. had not tried any of the other alternative treatment options on Dr. Mubang’s checklist form, such as physical therapy, chiropractic, muscle injections, or surgery. Despite the minimal objective findings in Patient W.B.’s history, Dr. Mubang began to prescribe escalating amounts of oxycodone to Patient W.B. On December 13, 2008, Dr. Mubang prescribed 120 30 mg tablets of oxycodone to Patient W.B. Then, he increased the amount of oxycodone he prescribed to Patient W.B. over the following monthly visits as follows: 150, 180, 210, 210, 240, 240, and ultimately settling at 270 30 mg tablets of oxycodone per month. From December 13, 2008, to August 24, 2010, Dr. Mubang prescribed Patient W.B. 4,050 30 mg tablets of oxycodone. On July 11, 2009, in addition to oxycodone and Soma, Dr. Mubang added Xanax and Fiorinal with codeine to Patient W.B.’s monthly prescription regimen. Like with Patient B.B., Dr. Mubang prescribed Xanax to Patient W.B. based on Patient W.B.’s answers to his checklist anxiety questionnaire. On July 11, 2009, Dr. Mubang saw Patient W.B. and renewed his medication. He scheduled Patient W.B. to return on August 9, 2009; however, Patient W.B. missed the appointment. Patient W.B. next visited Dr. Mubang two months later, on October 13, 2009. Dr. Mubang failed to document the reason for Patient W.B.’s three-month absence. He failed to document if Patient W.B. continued to receive pain medication from another source. He did not note whether Patient W.B. experienced withdrawal symptoms without his oxycodone for two months or how Patient W.B. managed his pain without oxycodone for two months. Dr. Mubang admitted during the hearing that, “[i]t is important to me to know why he misses visits. And you're right. Your point is well-taken.” Dr. Mubang’s own controlled substance agreement, which was executed by Patient W.B., explicitly stated that renewals are contingent on keeping scheduled appointments. Despite the unexplained absence, on October 13, 2009, he renewed Patient W.B.’s prescriptions for 270 tablets oxycodone, 30 tablets Soma, 60 tablets Xanax, and 90 tablets of Fiorinal with codeine. Dr. Mubang should not have restarted Patient W.B. at the same high dosage of oxycodone that he had previously prescribed, as it was potentially fatal. On November 10, 2009, Dr. Mubang ordered a urine drug screen for Patient W.B. The drug screen was positive for cocaine and hydromorphone. The drug screen was negative for the prescribed medications Soma (carisoprodol) and Xanax (alprazolam). Based upon the November 10, 2009, drug screen result, the standard of care required Dr. Mubang to refer Patient W.B. to a drug treatment center. When questioned about the positive cocaine result, Dr. Mubang’s expert, Dr. Simopoulos, testified, “That’s the part where this patient has a substance abuse disorder, obviously.” Dr. Simopoulos opined that, “if you are going to continue prescribing in this case, because the patient has duel diagnoses, you would want the input of a psychiatrist for this case.” Patient W.B. next visited Dr. Mubang approximately three months later on February 9, 2010. Again, Dr. Mubang failed to document the reason for the absence. At the February 9, 2010, visit, Dr. Mubang ordered a urine drug screen for Patient W.B., which returned completely negative results. After a multi-month absence and with a completely negative urine drug screen, Patient W.B. would have been opioid negative. In his 2012 deposition, Dr. Mubang theorized that the completely negative result may have been because Patient W.B. drove himself to his appointment and Dr. Mubang instructed his patients not to drive while on medication. This made little sense. Despite the completely negative result and unexplained absence, Respondent prescribed Patient W.B. 270 tablets of oxycodone, 30 tablets of Soma, 60 tablets of Xanax, and 90 tablets of Fiorinal with codeine. Again, Dr. Mubang should not have restarted Patient W.B. at the same high dosage of oxycodone that he had previously prescribed, as it was potentially fatal. Despite prescribing 270 tablets of oxycodone per month to Patient W.B., or nine pills per day, Dr. Mubang testified at hearing that, “[i]f I give them what they call ‘breakthrough medications,’ like oxycodone, all these, they'll tell you some days they take it, some days they don't take it.” Dr. Mubang was aware that Patient W.B. did not require nine oxycodone tablets per day and that the amount of oxycodone he prescribed to Patient W.B. was not justified. The foregoing pattern of unexplained absence and completely negative urine drug screen result, followed by Dr. Mubang renewing prescriptions, was repeated in November 2010. From December 13, 2008, through November 10, 2010, Dr. Mubang prescribed potentially lethal doses of oxycodone, Soma, Xanax, and Fiorinal with codeine to Patient W.B. inappropriately, in excessive quantities, and without justification. From December 13, 2008, through November 10, 2010, Dr. Mubang neither performed nor did he document performing a complete and adequate physical examination or medical history to justify his prescribing of the potentially lethal doses of oxycodone, Soma, Xanax, and Fiorinal with codeine to Patient W.B. From December 13, 2008, through August 24, 2010, Respondent did not diagnose Patient W.B. with intractable pain prior to prescribing potentially lethal doses of oxycodone, Soma, Xanax, and Fiorinal with codeine to Patient W.B. To meet the standard of care, Dr. Mubang should have discontinued prescribing the amount of medication that he prescribed to Patient W.B. based on the minimal findings in Patient W.B.’s history and the minimal changes on examination. In addition, Dr. Mubang should have referred Patient W.B. to a drug treatment center. Patient M.H. From January 10, 2005, to May 29, 2012, Dr. Mubang provided pain management treatment to Patient M.H., who first visited him as a 29-year-old female, suffering lower back pain. Prior to seeing Dr. Mubang, on March 24, 2004, Patient M.H. visited Dr. Edward Jacobson. Dr. Jacobson noted that Patient M.H. had been in a car accident on February 21, 2004, and that Patient M.H. was complaining of headaches. He prescribed 15 tablets of Vicodin to her. On January 10, 2005, Patient M.H.’s first visit with Dr. Mubang, he prescribed her 60 tablets of Vicodin. On January 21, 2005, Dr. Mubang added clonazepam and Adderall to Patient M.H.’s medication regimen. Dr. Mubang’s note for the January 21, 2005, visit does not make any mention of Patient M.H. suffering from an anxiety disorder or ADD that would justify his use of clonazepam or Adderall, save for a simple “ADD” noted in the assessment/plan portion of the form. Dr. Mubang should have referred Patient M.H. to a psychiatrist for diagnostic confirmation of ADD before automatically prescribing (or refilling) the Adderall prescription. From June 15, 2005, to March 7, 2007, Dr. Mubang prescribed Valium in combination with clonazepam to Patient M.H. monthly. Then on March 23, 2009, he discontinued clonazepam and started Patient M.H. on 90 2 mg tablets of Xanax. Dr. Mubang neglected to document a justification for prescribing Patient M.H. benzodiazepine-class drugs, or for prescribing her a combination of two different benzodiazepine- class drugs, or for the changes he made to the benzodiazepines he prescribed. On January 6, 2009, Patient M.H. reported having lower back pain from a car accident in 2003. Dr. Mubang noted that Patient M.H. was the driver of a car that was rear-ended. He also noted that Patient M.H. did not lose consciousness during the accident and did not go to the emergency room. At the January 6, 2009, visit, Patient M.H. reported trying three alternative treatment methods for her pain. By her own report, Patient M.H. had not tried any of the other 18 alternative treatment options on Dr. Mubang’s checklist form, such as physical therapy, muscle injections, or surgery. In 2009, for unexplained reasons, Dr. Mubang began significantly increasing Patient M.H.’s opioid pain medication. In January 2009, he increased Patient M.H.’s Vicodin from 60 to 90 tablets per month, then in July 2009 from 90 to 120 tablets per month. On October 19, 2009, Dr. Mubang prescribed Patient M.H. ten 50 mcg patches of fentanyl in combination with 120 tablets of Vicodin. A 50 mcg fentanyl patch is intended to last for 72 hours; so, a prescription of ten patches is intended to last one month. Fentanyl is a very strong opioid. Based on Patient M.H.’s experience with opioids, Dr. Mubang’s prescribing fentanyl to Patient M.H. was potentially lethal. On November 16, 2009, Dr. Mubang discontinued fentanyl and started Patient M.H. on 90 15 mg tablets of oxycodone, which he increased to 120 tablets the next month. Dr. Mubang prescribed the oxycodone in combination with 120 tablets of Vicodin. At hearing, Dr. Mubang could not tell from his notes and was, therefore, unable to explain his rationale as to why he prescribed fentanyl to Patient M.H., or why he discontinued the fentanyl and started Patient M.H. on oxycodone. The limited documentation that was included in Dr. Mubang’s records contradicted his course of treatment, as he routinely documented that Patient M.H.’s pain was a two out of ten with medication. From March 8, 2010, to June 28, 2010, Dr. Mubang added and then discontinued prescribing Soma to Patient M.H. His records do not contain any justification for starting Patient M.H. on Soma or for stopping Soma. On May 3, 2010, Dr. Mubang ordered a urine drug screen for Patient M.H. The urine drug screen result was negative for the prescribed medication oxycodone. The standard of care required Dr. Mubang to ask about the reason for the aberrant result to determine whether she was taking the medications or diverting them. Depending upon Patient M.H.’s answer, he should have ordered a repeat urine drug screen at the following visit. Despite the negative test, Dr. Mubang continued to prescribe potentially lethal doses of oxycodone and Vicodin to Patient M.H. From January 10, 2005, through August 23, 2010, Dr. Mubang prescribed potentially lethal doses of Vicodin, Xanax, Adderall, Soma, Valium, clonazepam, fentanyl, or oxycodone to Patient M.H. inappropriately, in excessive quantities, and without justification. From January 10, 2005, through August 23, 2010, Dr. Mubang did not diagnose Patient M.H. with ADD or any other clinical indication to support his prescribing Adderall to Patient M.H. From January 10, 2005, through August 23, 2010, Dr. Mubang neither performed nor documented performing a complete and adequate physical examination or medical history to justify his prescribing of the potentially lethal doses of Vicodin, Xanax, Adderall, Soma, Valium, clonazepam, fentanyl, or oxycodone to Patient M.H. Dr. Mubang did not diagnose Patient M.H. with intractable pain prior to prescribing to the patient the potentially lethal doses of Vicodin, Xanax, Adderall, Soma, Valium, clonazepam, fentanyl, or oxycodone. To meet the standard of care in his treatment of Patient M.H., Dr. Mubang should not have prescribed fentanyl to Patient M.H. without sufficient medical justification, as doing so was life threatening. Respondent should have referred Patient M.H. to specialists, such as orthopedics, physical therapy, and psychiatry. To the extent Dr. Mubang documented referrals to specialists, he should have followed up on his ordering of referrals to minimize the amount of medications he provided to Patient M.H., instead of escalating the amounts of pain medicine he prescribed. Patient B.D. From November 11, 2010, to November 8, 2012, Dr. Mubang provided pain management treatment to Patient B.D., a then 24- to 26-year-old female. In addition to lower back pain, Patient B.D. was also diagnosed with fibromyalgia. Dr. Mubang’s medical records for Patient B.D. contain a note from Dr. Indira Koshy, a prior treating provider, for a visit on August 24, 2010, in New York. Dr. Koshy noted that Patient B.D. was “entering rehab” and that Patient B.D. has seizures when she does not take her medications. Dr. Koshy’s note indicates potential for doctor shopping. At no point during his treatment of Patient B.D. did Dr. Mubang address the note from Dr. Koshy, specifically; Patient B.D.’s entry into rehabilitation; Patient B.D.’s seizures when she did not take her medications; or Patient B.D.’s potential for doctor shopping. Dr. Mubang previously treated Patient B.D. at Care Point Medical Center as a covering physician. He testified that when covering as a physician he provided “continuation of care” and that his practice was not to change a patient’s medication. Despite his testimony, when covering at Care Point Medical Center, Dr. Mubang increased Patient B.D.’s oxycodone from 210 tablets per month to 240 tablets per month. Then, on November 11, 2010, when Patient B.D. visited his practice, Dr. Mubang decreased her oxycodone from 240 to 180 tablets. As discussed below, this decrease came after he received notice of Petitioner’s investigation. From November 11, 2010, until May 24, 2012, Dr. Mubang prescribed Patient B.D. 180 30 mg tablets of oxycodone, 30 or 60 10 mg tablets of methadone, 60 350 mg tablets of Soma, and 30 0.5 mg to 2 mg tablets of Xanax monthly. On June 21, 2012, Dr. Mubang changed Patient B.D.’s prescribed muscle relaxant from Soma to baclofen; and on July 19, 2012, he changed Patient B.D.’s prescribed anxiolytic medication from 60 0.5 mg tablets of Xanax to 60 2 mg tablets of clonazepam. Dr. Mubang did not document any justification for the foregoing medication changes. From September 13, 2012, until November 8, 2012, Dr. Mubang prescribed 112 8 mg tablets of Dilaudid, 28 10 mg tablets of methadone, and 60 tablets of clonazepam to Patient B.D. monthly. On June 23, 2011, Dr. Mubang performed a urine drug screen on Patient B.D. The drug screen was negative for benzodiazepines, even though he prescribed Xanax to Patient B.D. The urine drug screen was positive for methadone, despite Dr. Mubang’s testimony that his urine drug screen could not detect methadone. On December 8, 2011, and June 21, 2012, Dr. Mubang performed urine drug screens on Patient B.D. Both drug screens were negative for the prescribed medication methadone. The standard of care required a reasonably prudent physician to question the patient about the aberrant urine drug screens results and cease prescribing methadone to a patient whose urine drug screen was negative for the drug. Despite the negative test results, Dr. Mubang continued to prescribe methadone to Patient B.D. From November 11, 2010, through November 8, 2012, Dr. Mubang neither performed nor documented performing an adequate history or physical examination to justify his prescribing of the potentially lethal controlled substances to Patient B.D. From November 11, 2010, through November 8, 2012, based on Patient B.D.’s history and physical findings, Dr. Mubang’s prescribing of the controlled substances to Patient B.D. was excessive and without justification. From June 23, 2011, through November 8, 2012, Dr. Mubang failed to address Patient B.D.’s aberrant urine drug screen results. To meet the standard of care in his treatment of Patient B.D., Dr. Mubang should not have prescribed the quantity and combination of drugs he prescribed to Patient B.D. He should have referred Patient B.D. for a rheumatology consult to confirm or rule out fibromyalgia and other diseases. He should have offered more physical therapy, and other, non-opioid modalities of care, and he should have routinely followed up with Patient B.D. to ensure that she was complying with his orders. Dr. Mubang testified that Soma was part of the “holy trinity,” which is a slang drug term used to refer to the prescription combination of oxycodone, a benzodiazepine, and Soma. He prescribed the “holy trinity” to five of the six patients in this cause. Dr. Mubang’s Medical Records Dr. Mubang’s medical records for the six patients, who are the subjects of the Administrative Complaints, were generally lacking in specificity to justify the level of his prescribing. Some examples common to the patients at issue illustrate these shortcomings. For each visit for each of the patients, Dr. Mubang noted that the patient had straight leg raise pain at 30 degrees, even though he testified that a patient can have straight leg raise pain at 15, 20, 30, or 45 degrees. Maybe this was a coincidence, but more credibly it is a pattern of sloppiness or autofill by the doctor. Also, for each patient, Dr. Mubang routinely drew a line down one leg of the anatomical figure on his progress notes indicating radiculopathy, regardless of where the patient reported pain. At hearing, on multiple occasions, Dr. Mubang could not determine his rationale for changing a patient’s medication regimen, based on his progress notes. His own expert, Dr. Simopoulos, testified that, “there's not much rationale on the plans in--in Dr. Mubang's notes in general.” Dr. Mubang tried to justify the lack of documented rationale by explaining that if a subsequent treating physician needed to know why he made medication changes, the physician would just call him and ask. While this should be true in an ideal world, his attempted justification is contrary to the purpose of medical records, which is continuity of care. No doctor, regardless of his education and experience, can be expected to remember every detail about every patient when he only sees the patient periodically. The medical record and doctor’s notes comprise his guide to ensuring the patient receives continuous, appropriate care. In addition to lacking in rationale, both experts were unable to read some of Dr. Mubang’s handwritten notes due to legibility. His own expert testified that, “The hardest part about these records is, obviously, how legible they are. I wish they were more legible.” Dr. Mubang’s medical records were inadequate for all six of the patients at issue here. Dr. Mubang’s Defenses Dr. Mubang passionately testified at hearing that he practices addiction medicine, that he prescribes Suboxone, and that his goal is to titrate patients’ medication. However, Dr. Mubang’s interest in addiction medicine and Suboxone is a recent phenomenon. In his 2012 deposition, he did not mention practicing addiction medicine, and the word Suboxone does not even appear in that deposition. Dr. Mubang titrated the medication he prescribed for four of the six patients in this cause. His reasoning for titrating the patients’ medication changed from his deposition testimony to his hearing testimony. In his 2018 deposition, he testified that he reduced the patients’ pain medication because the patients’ conditions were improving, and his goal was to titrate the medication. At hearing, he asserted the theory that he changed his prescribing practices because pharmacies contacted him and told him that they would no longer fill prescriptions written for such large quantities. The first of these is based upon a consideration of quality of care, while the second is based upon the practical reality of changing pharmacy practices as the dangers of over-prescribing opiates started to become more prevalent in the eyes of health professionals and regulators. On September 2, 2010, Investigator Victor Troupe personally served Dr. Mubang with a notice of investigation and a subpoena for medical records for Patients A.M., B.B., C.C., W.B., and M.H., among others. Following receipt of the notice of investigation, the doctor radically changed his prescribing practice for the patients in this cause. For ten months, Dr. Mubang prescribed Patient A.M. 270 tablets of oxycodone. Then on September 24, 2010, three weeks after being served by Petitioner, Respondent reduced Patient A.M.’s prescription of oxycodone from 270 tablets to 210, and then from 210 tablets to 180. For five months, Dr. Mubang prescribed Patient C.C. 290 tablets oxycodone. Then on September 9, 2010, Respondent reduced Patient C.C.’s prescription of oxycodone from 290 tablets to 210. At the patient’s next visit on January 5, 2011, Dr. Mubang reduced the patient’s prescription of oxycodone from 210 tablets to 180. Dr. Mubang also reduced Patient C.C.’s methadone. For five months, he prescribed 180 10 mg tablets of methadone to Patient C.C., but he reduced that number first to 60 tablets, then to 30, then discontinued the prescription. Further, in a matter of three visits, the doctor went from prescribing Patient C.C. 470 pain pills per month to 180 tablets. For ten months, Dr. Mubang prescribed Patient W.B. 270 tablets of oxycodone. Then on November 6, 2010, Patient W.B.’s first visit after the doctor received notice of the investigation, he reduced Patient W.B.’s prescription of oxycodone to 240 tablets, then to 210 on the next visit. For five months, Dr. Mubang prescribed Patient B.D. 240 tablets of oxycodone. Then on November 11, 2010, Patient B.D.’s first visit with the doctor after he had received notice of the investigation, he reduced Patient B.D.’s prescription of oxycodone to 180 tablets. The logical explanation for Dr. Mubang’s sudden reduction in amounts of pain medication prescribed is that the Petitioner’s notice of investigation triggered him to change his prescribing practice. The notice of investigation might have been his “eureka” moment or it might have served as a wake-up call to him concerning his prior over-prescribing practices. The evidence clearly and convincingly demonstrates that Dr. Mubang used little critical medical judgment when prescribing dangerous controlled substances to the patients in this matter. His diagnoses were based solely on patient report, and his primary tool for treating these patients was the prescription of controlled substances without first exhausting less harmful treatment modalities or combining lower doses of controlled substances with his patients seeking other treatment modalities.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Medicine enter a final order: finding that Respondent, John Nkolo Mubang, M.D., violated sections 458.331(1)(nn), 458.331(1)(q), 458.331(1)(t), 458.331(1)(m), and 458.331(1)(cc), Florida Statutes, as charged in Petitioner’s Administrative Complaints; and revoking Dr. Mubang’s Florida medical license. DONE AND ENTERED this 25th day of June, 2019, in Tallahassee, Leon County, Florida. S ROBERT S. COHEN 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 25th day of June, 2019. COPIES FURNISHED: Chad Wayne Dunn, Esquire Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 (eServed) Dale R. Sisco, Esquire Sisco-Law 1110 North Florida Avenue Tampa, Florida 33602 (eServed) Zachary Bell, Esquire Prosecution Services Unit Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 (eServed) Claudia Kemp, JD, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way, Bin C-03 Tallahassee, Florida 32399-3253 (eServed) Louise Wilhite-St Laurent, General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 (eServed)
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
