The Issue Whether Petitioner should be granted a Retail Pharmacy Drug Wholesale Distribution Permit, pursuant to Subsection 499.01(2)(f), Florida Statutes (2009).1
Findings Of Fact Background Petitioner holds Florida Community Pharmacy License No. PH23699 (the “pharmacy license”), pursuant to Chapter 499, Florida Statutes. The establishment is located at 1507 Park Center Drive, Suite 1L, Orlando, Florida 32835 (“establishment”), where Petitioner’s records are stored. On or about July 29, 2009, Petitioner submitted the first portions an application to Respondent for a Retail Pharmacy Wholesaler Distributor Permit, pursuant to Subsection 499.01(2)(f), Florida Statutes (“application”). On September 16, 2009, Respondent's drug agents conducted an onsite inspection of the establishment (“inspection”) for purposes of assisting in Respondent’s determination of whether to issue the permit to Petitioner. On or about November 13, 2009, Respondent notified Petitioner that Respondent intended to deny the application (“notice”), and Petitioner filed a petition for administrative review, raising disputes of material fact (“petition”). Prescription Drug Inventory and Petition as a “Retail Pharmacy” To qualify as a retail pharmacy, Petitioner must have adequate inventory on hand that would be required by the general public for a variety of medical conditions. On the date of inspection, there was inadequate inventory on hand. There were only 18 commercially-available prescription drugs. Many of the drugs were injectables, which would only fill the needs of a very specific and limited patient population. At the time of inspection, Petitioner’s on-hand inventory of prescription drugs lacked any opiate painkillers and any drugs indicated for treatment or maintenance of (i) high blood cholesterol levels, (ii) systemic bacterial infections (oral antibiotics), (iii) osteoporosis, (iv) cough (syrups), (v) viral infections, (vi) depression, and (vii) asthma. These are some of the most commonly-required drugs in the pharmacological arsenal. Petitioner’s specialization in the area of compounded prescription drugs is evidenced by Petitioner’s prescription drug inventory and the nature of the prescriptions Petitioner filled in the months leading up to inspection. Most of Petitioner’s on-hand prescription drug inventory was composed of compounded prescription drugs or ingredients to be used in compounding prescription drugs. Less than eight percent of Petitioner's prescription drugs, or about 18 items, consisted of commercially-available prescription drugs in finished dosage forms. In the two-month period before September 29, 2009, Petitioner did not dispense a single dose of commercially- available, finished-form prescription drugs. All were specially-prepared or “compounded” products tailored to the specific needs of individual patients. Petitioner, as a result of an inability to meet the most basic and commonplace prescription drug needs of the general public, lacked adequate inventory required by the general public. Petitioner served a specific and limited patient population: i.e., those patients requiring specially-compounded prescription drugs and those rare patients whose needs could not be met by commercially-available products. Petitioner's explanation as to the reason for having only 18 commercially-available prescription drugs available at the time of inspection is not persuasive; Petitioner, therefore, was not a retail pharmacy. Life Specialty Pharmacy Medical Equipment and Supplies, Inc.: Petitioner’s Unauthorized Source for Prescription Drugs Life Specialty Pharmacy Medical Equipment and Supplies, Inc. (“Life Specialty”), a separate entity from Petitioner, is under common control with Petitioner. It has the same owners, principals, and pharmacy department manager. Life Specialty holds Community and Special Parenteral/Enteral Pharmacy License No. PH22346 for an establishment located at 1507 Park Center Drive, Suite 1L, Orlando, Florida 32835. It is not authorized under Florida law to purchase, receive, own, or distribute prescription drugs. Petitioner’s prescription drug inventory at the time of inspection included certain quantities of Sarapin, a prescription drug. Life Specialty acquired and received Sarapin from a Kmart pharmacy that is no longer in business. At the time Life Specialty acquired and received the Sarapin from Kmart pharmacy, that drug was readily available from Life Specialty’s prescription drug wholesale suppliers. Life Specialty later transferred the Sarapin to Petitioner. Life Specialty lacks any permit or authorization under Part I of the Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes (Act), to engage in the wholesale distribution of prescription drugs. Petitioner, nevertheless, received prescription drugs from Life Specialty, and many of these drugs were in Petitioner’s prescription drug inventory at the time of inspection, including prescription drugs compounded by Life Specialty. Those drugs included: Sarapin Ketamine Hydrochorlide USP Progesterone Micro USP Chloral Hydrate (CIV), Crystal USP 100% 125gm Testosterone Propionate Micro USP Ketamine Hydrochloride USP 100% Powder 25mg Amphotericin B USP 100% Powder 1gm Cyclobenzaprine HCl USP Recordkeeping and Pedigree Papers During the course of the inspection, Respondent requested the opportunity to review pedigree papers and other source-related records for the prescription drugs Petitioner received from Life Specialty. Specifically, Petitioner could not produce any pedigree papers for prescription drugs received from Life Specialty. Petitioner received from Life Specialty, without a valid pedigree paper, the following: Sarapin Ketamine Hydrochorlide USP Progesterone Micro USP Testosterone Propionate Micro USP Cyclobenzaprine HCl USP Recordkeeping Petitioner did not acquire all of its pedigree papers contemporaneously with the underlying transactions. Petitioner acquired many of the pedigree papers for the prescription drugs in its inventory after the Respondent's inspection. Petitioner's explanation for these failures was not credible.
Recommendation Based on the Findings of Facts and the Conclusion of Law cited above, it is RECOMMENDED that the Department of Health enter a final order, denying Petitioner's application for a permit to act as a retail pharmacy drug wholesale distributor. DONE AND ENTERED this 1st day of September, 2010, in Tallahassee, Leon County, Florida. S DANIEL M. KILBRIDE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 1st day of September, 2010.
The Issue Has Respondent, Charles E. Schutt, D.D.S., violated Sections 466.028(1)(m) and (p), Florida Statutes, as alleged in the Amended Administrative Complaint, Department of Health Case No. 92-02364?1
Findings Of Fact Respondent is licensed to practice dentistry in Florida. His license number is DN005795. On and off commencing December 30, 1985, and ending April 20, 1987, Respondent treated a patient known as J.G. She was subsequently known as J.W. She is now known as J.E.D. During the treatment Respondent prescribed the patient J.G. Mepergan Fortis 50 mg on numerous occasions. Mepergan Fortis is a Schedule II controlled substance. It is an opoiod analgesic. It contains 50 mg of Demerol. Demerol is a Schedule II controlled substance and is an opoiod analgesic. Mepergan Fortis also contains Phenergan 25 mg. In this combination the Phenergan potentiates the effect of the Demerol. Schedule II controlled substances present a high potential for abuse in relation to possible addiction. Respondent prescribed Mepergan Fortis in response to the patient's complaints and upon his clinical findings. The issue is raised whether the prescriptions were in excessive or inappropriate quantities, thus not in the best interest of the patient and not in the course of professional practice. On December 30, 1985, when Respondent first saw J.G., it was on an emergency basis. When the patient presented she complained that she had a "tooth ache." The tooth involved was No. 30. Respondent provided treatment through surgery known as an "apico" or "apicoectomy." On that date Respondent prescribed 30 Mepergan Fortis 50 mg and 15 Valium 10 mg. That series of prescriptions was repeated on January 2, 1986. Between the prescriptions given on December 30, 1985, and the repeat prescriptions on January 2, 1986, the patient's record reports that the patient had to take 2 to 3 pain medications at one time to get comfortable. The patient record indicates that C.E.S., taken to mean the Respondent, said that this was okay. The note in the patient's record concerning the amount of medication "to get comfortable" was entered December 31, 1985. On January 9, 1986, the patient J.G. received another prescription of Mepergan Fortis 50 mg from Respondent. This was a prescription for 20 tablets. An entry was made in the patient record that at the time the patient still had some swelling but the swelling should subside. On January 14, 1986, the record for patient J.G. indicates that the patient called and stated that she had some feeling in her lower lip area that was coming back and that she had pain and wanted pain medication. A note was made that C.E.S. (Respondent) would need to see the patient. A note reflects that there was still some swelling. A note was made that the patient should continue heat and antibiotics. A prescription was provided for 40 tablets V-Cillin K 500 mg. On January 14, 1986, another prescription was written by Respondent for Mepergan Fortis 50 mg, 20 tablets. On that date a note was made that the patient should call tomorrow to inform the office how she was doing. A note was made on that date that C.E.S. (Respondent) would like to see the patient in a week. The patient J.G. was seen on February 28, 1986. She was prescribed 30 tablets of Mepergan Fortis 50 mg on that date. On March 7, 1986, an entry was made in the patient record that J.G. was still hurting. A prescription for 25 tablets, Mepergan Fortis 50 mg was written on that date together with V-Cillin K 500 mg, 40 tablets. On March 14, 1986, the patient J.G. returned to Respondent for extraction of tooth No. 30. On that date the patient was prescribed 20 tablets of Mepergan Fortis 50 mg. On March 17, 1986, the patient received a prescription of 20 tablets of Mepergan Fortis 50 mg. On March 19, 1986, patient J.G. called Respondent's office stating that when she "breathed in" there was pain. The patient record notes that C.E.S. (Respondent) states that this sensation is not caused from the extraction of tooth No. 30. The patient was seen that day. C.E.S. (Respondent) checked the sensitivity of tooth No. 31. According to the patient's record the extraction site of tooth No. 30 was healing well. A prescription of 20 tablets of Mepergan Fortis, 50 mg was prescribed on that date. On March 27, 1986, the patient, J.G. complained that she was hurting and pointed to tooth No. 31. The patient said she was doing fine until the night before when she was eating. Upon examination C.E.S. (Respondent) explained that sometimes a tooth adjacent to the site of the extraction can be sensitive but usually quiets down. Further arrangements were made to address the patient's condition. Two 5 mg valium were prescribed for pre-op. On that date, a prescription was provided from Respondent to patient J.G. in the amount of 25 tablets of Mepergan Fortis 50 mg. The appointment that was to take place on March 28, 1986, for possible root canal therapy was rescheduled for April 16, 1986, upon the patient's request. On April 11, 1986, the patient called and said that she would be in Atlanta until April 21, 1986, and wanted pain medication. According to the patient record, C.E.S. (Respondent) declined to give the patient pain medication unless the patient was undergoing active and regular treatment. This was reported in the patient record as based upon "DPR Regulations." On November 5, 1986, the patient J.G. called Respondent's office. C.E.S. (Respondent) advised the patient that root canal therapy was necessary for tooth No. 18. According to the record, the patient agreed that she wanted to save that tooth. On that occasion, Respondent provided J.G. a prescription for 15 tablets of Mepergan Fortis and 40 tablets of Erythromycin, 250 mg. Some treatment was given to the patient for tooth No. 18 on that date with the expectation that the patient would be seen again in 10 days. On November 7, 1986, the patient called Respondent's office complaining that she still had some discomfort and requesting more pain medication for the weekend. According to the patient's record, C.E.S. (Respondent) "okayed" a prescription for 15 tablets of Mepergan Fortis. On November 11, 1986, according to the patient's record, the patient J.G. was still having pain in tooth No. 18 where the root canal had been done. C.E.S. (Respondent) opened the root canal, re-irrigated and devoted other attention to the problem. Respondent prescribed 15 tablets of Mepergan Fortis for pain on that occasion. On November 14, 1986, patient J.G. called Respondent's office from Miami complaining of pain and saying that she would fly back in the "p.m." According to the record, the patient reported that she had one pill left and was still having considerable pain. A note was made in the record that a prescription of Mepergan Fortis in the amount of 10 tablets would be left with a person named "Kay" at the Jiffy Store. In fact, that prescription was left at the Jiffy Store to be picked-up by the patient. On November 18, 1986, Respondent completed the root canal therapy on J.G.'s tooth No. 18. The patient's record notes that the patient was to return in three weeks for core build-up. On November 18, 1986, 15 tablets of Mepergan Fortis were prescribed for the patient. On November 19, 1986, the patient's record reflects that J.G. called reporting that she had a "terrible night" and was taking pain medication 2 or 3 at a time. The record reflects that the patient had some slight swelling. Twenty tablets of Mepergan Fortis were prescribed for the patient on that date. Forty-two Erythromycin tablets, 250 mg were also prescribed. According to the patient's record, on November 24, 1986, the patient called Respondent's office indicating that there was still some swelling, that she hurt a lot and it hurt to eat. She requested more pain medication. Respondent prescribed 28 tablets of Erythromycin 250 mg and 15 tablets of Mepergan Fortis 50 mg. On December 4, 1986, Respondent saw patient J.G. concerning tooth No. 18. On that date 15 tablets of Mepergan Fortis 50 mg were prescribed. According to the patient's record, on February 18, 1987, the patient was having "severe pain" in tooth No. 31. The tooth was marked for root canal therapy and therapy was provided on that date. On that date 20 tablets of Mepergan Fortis, 50 mg were prescribed with a prescription of 40 tablets of Erythromycin 250 mg. On March 2, 1987, in relation to tooth No. 31, there was an entry made in the patient's record that the patient was still hurting and that the tooth was sensitive to cold. C.E.S. (Respondent) made an adjustment on the tooth. On that date prescriptions of 20 tablets of Mepergan Fortis, 50 mg and 40 tablets of Erythromycin 250 mg were written. On March 5, 1987, tooth No. 31 was reopened for treatment based upon the patient's complaints of pain. The patient's record indicates that the patient was to return in about a week to decide how to proceed. On March 5, 1987, a prescription of 30 tablets of Mepergan Fortis was prescribed by Respondent. On March 9, 1987, the patient's record notes that the patient was still hurting in the area of tooth No. 31 and that C.E.S. (Respondent) had determined that an "apico" was to be done on the tooth. On March 9, 1987, thirty tablets of Mepergan Fortis were prescribed. On March 10, 1987, Respondent performed an apicoectomy on tooth No. 31. According to the patient's record, on March 11, 1987, the patient J.G. called Respondent's office and indicated that Demerol made her nauseated. Instead, J.G. requested Mepergan Fortis. Respondent prescribed 30 tablets of Mepergan Fortis, 50 mg on that date. On March 13, 1987, Respondent prescribed J.G. 20 tablets of Valium, 10 mg; 6 tablets of Phenergransupp, 50 mg; 40 tablets of Mepergan Fortis, 50 mg; and 40 tablets of Erythromycin. On March 16, 1987, patient J.G. presented to Respondent's office with a drain in her tooth that had been placed by another dentist on an emergency basis. According to the patient's record, C.E.S (Respondent) stated that he would leave the drain in until tomorrow. A note in the record on that date indicates that the patient preferred to have an antibiotic and pain medications through an I.V. given at her work. It was noted that her work was in a medical facility. The patient's record indicates that C.E.S. (Respondent) stated that this would be "fine." Demerol, 50 mg/ml was prescribed for the patient J.G. On March 17, 1987, Respondent removed the drain in J.G.'s tooth. The patient's record notes that the patient was receiving pain medication through I.M. and antibiotics through I.V. The medications were being administered by a nurse at the patient's place of employment. Respondent prescribed a 3 ml bottle of Demerol injectable, 50 mg/ml and 15 ampules of Phenergran, 50 mg/ml on that date. On March 19, 1987, the patient J.G. received 30 ml of Demerol, 50 mg/ml and 15 ampules of Phenergran, 50 mg/ml. The patient's record notes that there was some adema on that date and that the patient was reported to have taken three pain shots the day before of Demerol, 100 mg each time. On March 23, 1987, a note was made in the patient J.G.'s record concerning some compressibility experienced by the patient. Respondent prescribed 30 ml of Demerol, 50 mg/ml and 5 ampules of Phenergan, 50 mg/ml. On March 30, 1987, the patient record for J.G. indicates that the patient was still on antibiotics and was "spiking" a fever. Nonetheless, there is an entry that "the tooth does not hurt." On that date Respondent prescribed 20 tablets of Mepergan Fortis, 50 mg. On April 3, 1987, the patient called Respondent's office stating that she had an earache and wanted "something for swelling." The record notes that C.E.S. (Respondent) would give medication for pain but that nothing else is necessary. Respondent prescribed 40 tablets of Mepergan Fortis on that date. On April 8, 1987, the patient record for J.G. indicates that the patient had a little residual swelling and that the "pain level" was down quite a bit. Nonetheless, the record indicates that the patient still needed pain medication. On that date Respondent prescribed 40 tablets of Mepergan Fortis, 50mg. On April 13, 1987, the patient's record indicates that the patient J.G. called and stated that she would be in Miami for the remainder of the week and requested pain medication. On that date Respondent prescribed 20 tablets of Mepergan Fortis. On April 17, 1987, Respondent saw patient J.G. in his office. The patient was diagnosed with tendonitis, grade 4. Respondent prescribed 20 tablets of Mepergan Fortis 50mg, "1 cap of 4-6 hr prn for pain." On April 20, 1987, Respondent saw patient J.G. for TMJ treatment. On that date Respondent wrote a prescription for J.G. for 25 tablets of Mepergan Fortis. Thomas Eugene Shields, II, DDS, is licensed to practice dentistry in Florida. He reviewed the patient record for J.G. that has been described in relation to the prescription of Mepergan Fortis by Respondent. In Dr. Shields' opinion as a dentist, Respondent over-prescribed Mepergan Fortis. Dr. Shields considered Respondent's prescription of Mepergan Fortis to J.G. over time to be inappropriate. In Dr. Shields' opinion Respondent's prescribing of Mepergan Fortis to J.G. on some occasions was inappropriate as to the length of time prescribed and number of tablets prescribed. Dr. Shields referred to the frequency with which Mepergan Fortis was prescribed at times, given the closeness in time for writing the questioned prescriptions. He criticized the number of pills dispensed at a given time. In Dr. Shields' opinion there is a risk of addiction if Mepergan Fortis is over-prescribed. Given the amount and the frequency of the prescriptions of Mepergan Fortis by Respondent in this case, Dr. Shields' opinion is that any patient would suffer the risk of becoming addicted to the controlled substance. In his testimony Respondent explained that he prescribed Mepergan Fortis to J.G. because she kept complaining of pain. He commented that "some people just have a low tolerance for pain." Respondent testified that some people can take Mepergan Fortis every six hours and be comfortable while other people could take two every two hours and not be comfortable, given what their physical make-up may be. In commenting on the reason for these differences Respondent stated, "I have no idea." Given the nature of the procedures the patient was receiving Respondent had reason to believe her reports of pain. In particular, Respondent testified about the fact that a root canal can sometimes cause excruciating pain and that in doing an "apico," when you go into the bone to remove part of the root "that's pretty tough, too, a pretty tough procedure." In summarizing the reasons for prescribing the amount of prescription medications given to J.G. and whether it was inappropriate or excessive, Respondent expressed the opinion that the medications given to J.G. were necessary to alleviate the pain she had. Respondent stated that "she was a difficult patient. And we get them." Dentists other than Petitioner's principal expert, Dr. Shields, and Respondent testified concerning Respondent's practice prescribing Mepergan Fortis. Dr. Robert Romans, D.M.D. testified by deposition. He specializes in periodontics. In reviewing Respondent's record concerning the treatment of J.G., Dr. Romans referred to what he saw as "a pattern of rather strong medications in both amount and numbers." He had concerns about the quantities of those drugs being prescribed by Respondent. The drugs being referred to in his remarks were Valium, Mepergan, and Demerol. On the whole, based upon the excerpted testimony from his deposition that was introduced, Dr. Romans rendered no useful opinion concerning the alleged excessive or inappropriate quantities of Mepergan Fortis prescribed by Respondent in treating J.G. Dr. David D. Woods, an oral surgeon offered his testimony by deposition concerning Respondent's treatment of J.G. His testimony was based upon Respondent's treatment record that has been described. Dr. Woods referred to the amount of narcotics given to J.G. by Respondent as "a lot of narcotics given obviously, but it really -- it really depends on a patient." Dr. Woods testified that J.G. was probably a drug seeker and a manipulator. Having considered the excerpts in the deposition, Dr. Woods did not express an opinion concerning Respondent's prescription of Mepergan Fortis to the patient J.G. that can be relied upon. Dr. John D. Zongker practices in endodontics. He is licensed in Florida. He had the opportunity to review Respondent's treatment record for J.G. that has been described concerning prescribing Mepergan Fortis and Valium. In his deposition testimony Dr. Zongker referred to J.G., through "hind- sight," as a patient who has definitely had an abuse problem and who requested a lot of medication, that it was easy to be "hood- winked" by those kinds of patients, and that it was something for which the practitioner needed to be alert. Dr. Zongker refers to the amount of narcotics prescribed as a "little high" because of manipulation by the patient. In the deposition, in addressing whether the quantity of drugs prescribed by Respondent was high in the case of J.G., Dr. Zongker said that he felt that this was an easy trap to get into where the patient may have some legitimate pain and complaint. In which case, at some point a decision has to be made about whether the pain is real. But Dr. Zongker really arrives at no opinion in that deposition testimony concerning the prescribing by Respondent. In his testimony at hearing, Dr. Zongker indicated that he considered it appropriate for a dentist to continue use of pain medication such as Mepergan Fortis as long as the dentist felt that he was still dealing with the same pain and that the dentist believed that the patient was in pain. Dr. Zongker expressed the opinion the J.G. was a patient who required more than the normal amount of medication for the procedures she was undergoing. Dr. Zongker refers to the large dosage of Mepergan Fortis in the numbers of tablets and the fact that it had extended over several episodes of different types of treatment. He refers to the necessity at some point in time to make a decision whether a patient such as J.G. has a clinical need for the medication or a psychological need. What makes it more difficult to determine in this instance, under Dr. Zongker's analysis, is that there were a number of procedures over time making it "more hazy as to what that cut-off is" for determining whether the patient's need was clinical or psychological. Having considered all of the opinions by the experts, Dr. Shields' opinion that Respondent prescribed J.G. excessive and inappropriate quantities of Mepergan Fortis on certain occasions, when taking into consideration the amounts within the prescriptions and the frequency with which they were written, is accepted. As Petitioner's counsel conceded in that party's proposed recommended order, the proof was insufficient to show that Respondent failed to keep written dental records justifying the course of treatment of J.G. in relation to patient history, consent forms for procedures performed, treatment plans, phone call logs, duplicate copies of prescriptions or other items aside from the patient record. There was significant delay in bringing this action against Respondent. Consequently, the patient history, consent forms for treatment, treatment plans, phone call logs, and copies of prescriptions that had been maintained by Respondent were no longer available nor was it necessary for Respondent to have preserved them. The patient record constituted of patient contact entries and other data had been provided to Petitioner from another source. It is adequate to explain the circumstances concerning the prescribing of Mepergan Fortis.
Recommendation Upon consideration of the facts found and the Conclusions of Law reached, it is RECOMMENDED: That a Final Order be entered finding Respondent in violation of Section 466.028(1)(q), Florida Statutes, now Section 466.028(1)(p), Florida Statutes; imposing a 60-day suspension and a $3,000 administrative fine; and dismissing the allegations in the Amended Administrative Complaint that Respondent violated Section 466.028(1)(m) and (y), Florida Statutes. DONE AND ENTERED this 28th day of July, 2000, in Tallahassee, Leon County, Florida. CHARLES C. ADAMS 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 28th day of July, 2000.
The Issue The issues are whether Respondent is guilty of: 1) failing to practice medicine within the applicable standard of care, as required by section 458.331(1)(t), Florida Statutes, by inappropriately and excessively prescribing one or more controlled substances and 2) failing to keep medical records that justify the course of treatment for prescribing one or more controlled substances, as required by section 458.331(1)(m), Florida Statutes, by failing to document patient histories, examination results, test results, results of drugs prescribed, dispensed or administered, or reports of consultations or hospitalizations, or failing to justify the amount and dosage of pills prescribed.
Findings Of Fact Introduction At all material times, Respondent has been a physician licensed to practice medicine in Florida. His license number is ME 33389. His practice is located in Delray. Respondent is not Board certified in any specialty. He appears to have practiced for many years. In 1987, Respondent was disciplined for a failure to keep medical records. The Board of Medicine reprimanded Respondent, imposed $2000 of costs and one year's probation, required 30 hours' coursework in risk management and recordkeeping, and restricted Respondent's license by requiring the submission of quarterly reports covering prescribing activities, among other things. In 2007, Respondent was disciplined for a violation of the requirements imposed on a dispensing practitioner. The Board of Medicine imposed a fine and probation. The Board also required a drug course, a law and rules course, ten hours' coursework in the responsibilities of dispensing practitioners and 25 hours' community service. This case involves Respondent's use of chronic opioid therapy for chronic and breakthrough pain not associated with cancer or other terminal disease. As detailed in the Conclusions of Law, the issues require consideration of whether Respondent's medical records are adequate to justify these prescriptions and whether these prescriptions are inappropriate, excessive, or otherwise unjustified, so as to violate the applicable standard of care. In attempting to prove these two sets of violations, Petitioner has limited its allegations to Respondent's prescriptions of five Schedule II controlled substances and one Schedule III controlled substance. The five Schedule II controlled substances are oxycodone, roxicodone, Oxycontin®, Oxyfast®, and Percocet®. The lone Schedule III controlled substance is Norco®. A Schedule II controlled substance has a high potential for abuse and has a currently accepted, but severely restricted, medical use in treatment in the United States. Abuse of a Schedule II controlled substance may lead to severe psychological or physical dependence. A Schedule III controlled substance has a lower potential for abuse and a currently accepted medical use in treatment in the United States. Abuse of a Schedule III controlled substance may lead to moderate or low physical dependence or high psychological dependence. People have used opium for pain relief for thousands of years. The pharmacological production of opioid drugs started after the identification of the morphine alkaloid in 1806. By the end of the 19th century, in the United States, legal controls were imposed on opioids. By the 1940s, opioids could be legally used only if prescribed by physicians, pursuant to strict regulatory controls. By the end of the 20th century, tension had emerged between physicians reluctant to prescribe opioids due to professional-liability considerations and advocates of pain control. Particularly contentious issues are whether and how to prescribe opioid therapy for chronic pain not associated with terminal disease. Oxycodone and hydrocodone are short-acting opioids with an onset of 30-90 minutes and duration of 4-6 hours. Roxicodone is oxycodone hydrochloride. In controlled-release form, such as Oxycontin®, oxycodone hydrochloride is a long-acting opioid with an onset of 1-12 hours and duration of 8-72 hours. With a quicker onset than oxycodone in pill form, Oxyfast® is a liquid containing 20 mg of oxycodone hydrochloride in a one-ml bottle. Percocet® is oxycodone and acetaminophen: a dosage of "10/325" is 10 mg of oxycodone and 325 mg of acetaminophen. Norco® is hydrocodone and acetaminophen: a dosage of "10/325" is 10 mg of hydrocodone and 325 mg of acetaminophen. Methadone is an inexpensive synthetic opioid with long- acting effect. The half-life of methadone typically ranges from 15-60 hours, but may extend to 120 hours. The long, variable half-life of Methadone discourages its wider use in pain control because of difficulties in maintaining not more than therapeutic levels. During the time in question, Oxycontin® was relatively expensive among the opioids listed in the preceding paragraph. At that time, one 30-mg roxicodone pill cost an uninsured patient about $0.70-$1.00, one 40-mg Oxycontin® pill cost an uninsured patient about $8.00, and one 80-mg Oxycontin® pill cost an uninsured patient about $14.00. The record does not reliably establish street values for these drugs, but all of them were traded and consumed at high rates illegally on the street. Short-acting opioids are more appropriate for breakthrough pain, which is a temporary spike in pain above chronic-pain levels due, for example, to physical exertion. A short-acting opioid is well-matched to the relatively short duration of breakthrough pain. This record does not permit resolution of the dispute over whether long-acting opioids are more effective than short-acting opioids for the relief of chronic pain. Generally, prescribed opioids pose distinct risks of consumption and diversion by the patient. For the opiate-naïve patient, doses of opioids that may be easily tolerated by the opiate-tolerant patient may cause potentially life-threatening side effects, including respiratory depression. For the opioid- tolerant patient who is consuming opioids not prescribed by the practitioner--from other, undisclosed practitioners or from street purchases--additional doses of prescribed opioids may cause the same life-threatening side effects as those faced by the opiate-naïve patient, although, with controlled dosing among opioid-tolerant patients, opioids typically may be increased until pain control is attained. Pain medicine practitioners may manage these risks, in part, by administering periodic urinalyses to their patients. The urinalyses administered to the ten patients in this case were threshold tests that would detect the presence of various substances above a certain level. Such tests would uncover opioid-naïve patients and patients consuming other controlled substances, but not the level of any controlled substance detected by the test. Sometimes, opioid rotation may achieve the desired analgesic effect at relatively low doses. Otherwise, chronic pain may require increasing doses of the same opioid to obtain the same relief originally obtained by lower doses, although some patients may find effective relief for extended periods at a dosing level that is not increased. Less frequently, higher opioid doses may produce hyperalgesia. Optimally, effective pain management is multifaceted, including such disciplines or techniques as psychotherapy, cognitive behavioral therapy, biofeedback, relaxation techniques, physical therapy, and reliance on nonopioid analgesics. But limits on insurance coverage or lack of insurance and the relatively high costs of most of these alternative disciplines or techniques may legitimately require the practitioner to rely more on the relatively inexpensive opioids. Even Petitioner's expert witness admitted, "Sometimes I have self-pay patients who are on opiates only because they can't afford anything else." (Pet. Ex. 4, p. 7.) Petitioner's expert acknowledged that roxicodone "is something you tend to give people who have no insurance." (Tr., p. 85.) Cost considerations may also require that the practitioner break down what would be a single prescription of, say, 100 pills into two prescriptions of 50 pills each, so the patient can effectively pay for his prescription in two installments. Again, Petitioner's expert witness admitted that there was nothing wrong with this practice. (Pet. Ex. 4. p. 41.) None of the ten patients addressed in this case had insurance during the relevant period. (One patient potentially had COBRA coverage that would have expired long before the period in question.) Although at least a couple of patients were employed in professions in which at least moderate earnings might be expected, the record does not reliably describe the financial resources of any of the ten patients. The record contains no evidence of injury to the patients discussed below in terms of the care, including prescribed opioids, that they received from Respondent. Excessive consumption of prescribed or diverted opioids is dangerous and can be fatal. But, as Respondent's expert witness testified, the fatal combination seen "excessively" in the eight deaths per day in Florida from prescription drug abuse is opioids; benzodiazepines, such as Xanax®; and muscle relaxants, such as Soma®. Although Respondent prescribed medications in all three categories, Petitioner has not alleged any violations arising from Respondent's prescriptions of any drug besides the opioids discussed above, so Respondent's prescriptions of benzodiazepines and muscle relaxants to these ten patients are generally omitted from the Findings of Fact. As Petitioner's expert testified, there is no quantitative criterion for the standard of care in prescribing opioids. (Tr., pp. 29 and 108.) The standard-of-care determination is dependent on the facts. Two facts of importance are the achievement of pain relief and the restoration or maintenance of function in the patient. The record contains ample evidence of the extent of pain relief, although nearly all of it is in the form of reports from patients, whose credibility is difficult to assess. The record contains relatively little evidence of functionality for most patients. As discussed in the Conclusions of Law, contrary to the testimony of Petitioner's expert, a standard-of-care violation is not established, per se, by a medical-records violation. The record is problematic in several other respects. Most notably: 1) Petitioner's expert witness stated in his initial report to Petitioner that Respondent's medical records were adequate and justified the course of treatment (Tr., pp. 111-22); but 2) Respondent's expert witness stated that Respondent's medical records were inadequate, at least based on present practices. (Depo. Tr., Forest S. Tennant, Jr., pp. 51- 52.) Also, in what probably came as a surprise to Petitioner, its expert witness three times opined that, under certain conditions, a physician may lawfully deviate from the applicable standard of care in the prescription of opioids. (Tr., pp. 65, 90, and 95-96.) The testimony of each expert witness was uneven. Most of the flaws of Petitioner's expert are listed above, but he repeatedly tended to agree with the attorney asking him questions. Neither expert displayed an over-familiarity with the details of the medical records; sometimes, Respondent seemed somewhat unfamiliar with them too. Petitioner's expert is Board certified in the subspecialty of pain medicine and practices in Orlando; Respondent's expert is not Board certified in any specialty or subspecialty and has never practiced in Florida. But Respondent's expert thoughtfully explained how a higher blood pressure and pulse rate might be associated with under- medication, and a lower blood pressure and pulse rate might be associated with over-medication. Respondent's expert also recognized the difference between a medical-records violation and a standard-of-care violation. During the time in question, Respondent saw 15 patients daily, not 60 or more patients daily, as are seen by some high-volume opioid-prescribing physicians. The ten patients in this case are all residents of Florida, not residents of other states drawn to the opioid-prescribing practices of a compliant Florida physician. (One of the ten patients appears to have been a resident of Mississippi, but had a Florida driver license--tending dispel an inference that he was in Florida briefly for the purpose of obtaining opioids.) Almost always, Respondent obtained patient records from the physician who had been treating the patient immediately before he or she began seeing Respondent. And, at a time when the practice was not required by statute or rule, Respondent used urine screens to determine whether his patients were consuming the opioids that he was prescribing them. For none of the ten patients has adherence to the dosing practice of a preceding physician, per se, constituted compliance with the applicable standard of care. Except for a relatively brief period after acquiring the patient, Respondent could only satisfy the applicable standard of care by appropriate treatment, regardless of the dosing practice of the preceding physician. In large part, the purpose of administering urinalyses was to detect aberrant behavior by the patient. In this context, aberrant behavior means patient diversion of opioids or consumption of other opioids or other controlled substances without disclosure to Respondent or, in the case of illegal consumption of such substances, even with disclosure to Respondent. W. C. From February 12, 2007, through July 16, 2009, Respondent prescribed to W. C. 150 30-mg roxicodone pills and 120 15-mg roxicodone pills each month. Respondent first saw W. C. on June 20, 2001, when Respondent served as the medical director of the Pain Management Center in Miami. At the time of this initial visit, according to Respondent's medical records, Respondent complained of rheumatorial arthritis of the left knee, on which he had had surgery, two years earlier, to repair a tear of the medial collateral ligament. W. C. also complained of lower back pain and tendonitis in the left elbow and shoulder. The patient's situation was exacerbated by his job, which involved moving refrigerators. The initial note states that the patient's general practitioner, Dr. Martin Coleman, had prescribed him 5-mg pills of Roxicet®, and the patient had taken some Xanax® from his wife to relieve spasms and stress. The next office visit took place on July 16, 2001, at which time Respondent brought a "note," not medical records, from Dr. Coleman. According to Respondent's medical records, Dr. Coleman's note stated that the degenerative arthritis was of the right knee, not the left knee, which had been treated with Percocet®, which is similar to Roxicet®. Evidently relying on the patient's statement that he had tried his wife's Xanax®, the July 16 record states: "His anxiety is helped tremendously with Xanax®." At this time, Respondent saw W. C. for seven or eight months. These medical records are missing, but they are not at issue in this case. At some point, W. C. transferred to the Delray office of the Pain Management Center while this office was staffed by Drs. Morency, Rabinsky, and Weed. In November 2005, W. C. suffered a wedge fracture of the T12 vertebra, which caused him severe back pain, as a result of an automobile accident. On February 14, 2007, Respondent saw W. C. in the Delray office of the Pain Management Center, to which Respondent had since transferred. Among the records that Respondent reviewed was a neurological consultation dated September 7, 2006, in which the neurologist, Dr. Perry Hoeltzell, described cervical, left arm, left lower back, and left leg complaints since the November 2005 accident. Respondent also examined an MRI of the spine taken on September 7, 2006, that showed a T12/L1 collapse of the disc with chronic anterior wedging of the T12 vertebra. The appearance was of a flexion trauma. These conditions supported the finding or complaint of cervical radiculopathy of C3 through C6 and lumbar radiculopathy of L4-5/L5-6. W. C. informed Respondent that he liked the flexibility of his current prescription of 150 pills of 30-mg roxicodone and 120 pills of 15-mg roxicodone monthly, so he could decide which dose to take when. However, W. C. did not appear to be an uncritical consumer of every controlled substance that he could get. The July 16, 2009, medical note reports that W. C. declined a renewal of Cymbalta®, saying that it did not work and, "I didn't think I needed it." At the time of the February 14, 2007, office visit and through the final office visit of July 16, 2009, W. C. was able to work and suffered no side effects. Each month, Respondent saw W. C. in the office and typically spent 15-30 minutes talking with him. The medical records over this period are inadequate and do not justify the opioid prescriptions that Respondent gave W. C. during this time. For two and one-half years, Respondent prescribed the same two prescriptions of roxicodone with medical records consisting of monthly reports of blood pressure, pulse, general appearance, patient history, and complaints, such as level of pain, the extent of pain relief, side effects, sleep, and mood. As tended to be his practice with all ten patients, Respondent never filled in the bottom of the medical-record form, which prompted insertion of the "plan." Respondent never recorded any diagnosis or general assessment of W. C., or recorded how he was managing the patient. For over two and one-half years, Respondent failed to document these important elements of medical records. This was too long for Respondent to claim that he was merely maintaining the prescription regime of the preceding physician until Respondent had the opportunity to assess the patient, discuss with the patient treatment alternatives, and develop a pain- management plan. In this timeframe, Respondent should have documented these tasks multiple times. The absence of this critical patient assessment and treatment information from the medical records means that the records fail to justify the course of treatment. Petitioner's expert witness opined that Respondent violated the applicable standard of care due to the excessive prescription of medications. But when asked why the prescribed medications were excessive, the expert responded, "the medical records," which, he explained, failed to provide an understanding of how the patient was managed, failed to provide a diagnosis, assessment, or treatment plan, and omitted any description of level of functioning, clinical exams, or physical exams. (Tr., p. 23.) Petitioner's expert witness described Respondent's medical records as "poor." (Tr., p. 27.) If there were any doubt that the basis of the expert's standard-of-care opinion was the inadequate medical records, he dispelled it in the following exchange: Q: Dr. Gerber, this prescribing of roxicodone 30 mg of 150 pills in conjunction with roxicodone 15 mg of 120 pills, what is your opinion about the appropriateness and whether or not the prescribing of those two--that combination is within the standard of care and why? A: Well, without medical records justifying it, if falls below the standard of care. There's no explanation of why these two potent opioids are being prescribed together. . . . (Tr., pp. 24-25.) Obviously, where the patients, other than W. C., do not testify, the ability of Petitioner's expert to opine as to the standard of care is limited to what he has learned of their care from the medical records and the testimony of Respondent, which supplies very little in addition to what is contained in the medical records. After an extensive discussion of the inadequacies of the medical records, in response to a standard- of-care question, the expert admitted that the lack of medical records left him "not able to formulate an opinion as to how this patient was managed." (Tr., p. 23.) Immediately after this statement, Petitioner's expert twice testified that the standard-of-care violation was due to the problems with the medical records. (Tr., pp. 23-24.) The frustration of Petitioner's expert witness, although understandable, does not justify elevating a medical-records violation to a standard-of- care violation--again, as explained in the Conclusions of Law. The sole attempt of Petitioner's expert to predicate a standard-of-care violation on something besides the inadequate medical records was unsuccessful. Although he elsewhere disclaimed reliance merely on the quantity of prescribed opioids as the sole basis of a standard-of-care violation, Petitioner's expert complained about Respondent's prescription of "these two potent opioids . . . together." (Tr., p. 25.) Of course, there is only one potent opioid at issue in the W. C. counts-- roxicodone. (Xanax®, which Respondent also prescribed to W. C., is not an opioid and, as noted above, is not alleged as a basis of any liability in this case.) If the two opioids were the two dosages of roxicodone, the expert's complaint appears to be a back-door attempt to object to the quantity of prescribed opioids--in isolation from other relevant factors. Significantly, Petitioner's expert testified that, with acceptable documentation, "one [of the roxicodone prescriptions] by [itself] might be acceptable" (Tr., p. 25)--implying that his underlying problem is with the quantity of this opioid that Respondent has prescribed. But, as Petitioner's expert witness conceded, "patients can have a lot of pain and require high doses of opioids even with minimal diagnostic studies." (Tr., p. 26.) Petitioner's expert eventually admitted that a monthly prescription of 120 pills of a hypothetical 45-mg roxicodone, which is slightly less than Respondent's prescription of 120 pills of 15-mg roxicodone and 150 pills of 30-mg roxicodone, might have met the standard of care, if "there was good documentation of physical functioning [and] the notes and records clearly documented an assessment and plan." (Tr., p. 31). For W. C., clinical reports amply documented injuries that could have accounted for the pain that W. C. consistently reported during the period in question. The record establishes sustained function during the course of treatment--and even beyond. Alone among the patients, W. C. testified to his extensive orthopedic problems in his back and to the role of Respondent and his medication regime in preserving W. C.'s functionality. Respondent's treatment of W. C. left one question unanswered. In general, Petitioner's expert rightly asked why Respondent did not offer or explore nonopioid treatments. (Tr., p. 27.) The absence of any consideration of nonopioid treatments is a deficiency in the medical records, but also relevant in determining whether Respondent met the standard of care. Respondent's usual explanation--the prohibitive costs of such alternative treatments--may not apply to W. C., who was continuously employed throughout his treatment, possibly even as the owner of the company for which he worked. Respondent testified: "He was a laborer, he had his own moving company." (Tr., p. 209.) But, standing alone, this question does not establish a standard-of-care violation. There is less, if any, value in the suggestion of Petitioner's expert that a standard-of-care violation may be based on Respondent's failure to prescribe methadone. As noted above, this record fails to establish that the standard of care requires the use of long-acting opioids for chronic pain, and this repeated suggestion by Petitioner's expert fails to account for the difficulties, noted above, in the use of this persistent opioid, which even Petitioner's expert admitted must be used "carefully." (Tr., p. 32.) Petitioner proved a medical-records violation, but not a standard-of-care violation. D. M. From January 8, 2007, through July 18, 2007, Respondent prescribed to D. M. a monthly regime of roxicodone and Oxycontin®. The sole exception to the monthly office visits with Respondent is an office visit dated February 5, 2007, which, judging from the handwriting on the note, involved another physician at the Pain Management Center. Respondent's prescriptions for January 8 and March 5 were for 100 30-mg roxicodone pills and 180 40-mg Oxycontin® pills. On April 2, Respondent increased the monthly prescription to 180 30-mg roxicodone pills while maintaining the number and dose of Oxycontin® pills. On April 30, Respondent increased the number of roxicodone pills to 200 monthly, but decreased the dosage to 15 mg, while maintaining the number and dose of Oxycontin® pills. On May 24, Respondent issued a prescription for 200 15-mg roxicodone pills, 100 30-mg roxicodone pills, and 180 40-mg Oxycontin® pills. On June 21, Respondent prescribed 200 15-mg roxicodone pills and 180 40-mg Oxycontin® pills. On July 18, Respondent prescribed 100 30-mg roxicodone pills and 180 40-mg Oxycontin® pills. D. M. is unique among the ten patients in two regards. She has the shortest treatment period at six months, and she is the only patient to have received Oxycontin® monthly for the duration of her treatment under Respondent. Another unusual aspect of D. M.'s case is Respondent's clear confusion about his treatment of her. Respondent testified that he first saw her on May 24, 2007. This testimony is contrary to the stipulation, and it is not borne out by the medical records. The medical notes for January 8 (Joint Ex. 2, p. 159), March 5 (Joint Ex. 2, p. 157), April 2 (Joint Ex. 2, p. 156), and April 30 (Joint Ex. 2, p. 155) all appear to be in the handwriting of the physician who filled out the medical note for May 24 (Joint Ex. 2, p. 346). D. M. bore a diagnosis of fibromyalgia, which is a diagnosis of a condition whose existence divides the medical community. However, associated with the diagnosis is widespread pain involving the muscles and soft tissues and sleep disturbances, both of which D. M. reported. Although the disease is not like a fracture or herniated disc in its ability to be confirmed by some form of imaging technology, the present record provides an inadequate basis to disregard the existence of this condition or dismiss the potential severity of the pain associated with this condition. In 1995, D. M.'s physician, Thomas Fitzpatrick, M.D., referred D. M. to John H. Gridley, Jr., M.D., who specialized in internal medicine and rheumatology. After an examination of this 35-year-old patient, Dr. Gridley diagnosed D. M. with what is now referred to as fibromyalgia. She has borne this diagnosis ever since. D. M. had been a patient of the Kendall office of the Pain Management Center since 2003. Her condition had deteriorated since 1995; she had spent two years in bed. During this time, she had received the opioids that Respondent later maintained. When D. M. first saw Respondent nearly 12 years later, she had gained 70 pounds, and her systolic blood pressure had increased 34 mm to 144/72. D. M. advised Respondent that the only medication that relieved her pain was Oxycontin®, so, after discussing diet and exercise, Respondent continued her existing prescription of Oxycontin® with roxicodone for breakthrough pain. On D. M.'s next visit, on March 5, no vital signs were taken. On her next visit, on April 2, her blood pressure had dropped to 102/78, although her pulse was 78. Her pain, which was reported as "6" on her first visit, was down to "5" on this visit. In addition to his confusion over when he started treating D. M., Respondent seemed confused by his own treatment plan for this patient. Alluding to his much-used explanation of financial constraints precluding the prescription of Oxycontin®, Respondent testified that, due to "financial reasons," "we converted one Oxycontin® to Roxy 30s, giving her exactly the same dosage. The patient was having financial problems. I remember that." (Tr., p. 227.) However, the record reveals no reduction in the relatively expensive Oxycontin® prescription, only an increase in the roxicodone prescription on April 30 and again on May 24. Later, Respondent testified that his office mistakenly increased the roxicodone prescription on April 30 from "100 to 180 milligrams." (Tr., p. 228.) However, this increase amounted to only 20 30-mg pills for the month or about 20 mg daily. The increase on May 24 was much larger--from 6000 mg/month of roxicodone to 9000 mg/month of roxicodone. This was also a mistake, but a much bigger one. D. M. never informed Respondent of the prescription error, which Respondent "didn't like." (Tr., p. 228.) Respondent reduced the June 21 prescription, probably to allow D. M. to use some of the extra roxicodone that she had on hand. (Tr., p. 228.) However, Respondent never attempted to explain how these two dosing mistakes happened or, if they were not mistakes, what justified these dramatic increases in opioids being prescribed to the patient. Respondent probably did not attempt a justification of these increased dosages because no justification existed: D. M. reported a small increase in pain from April 30 to May 24, but only from a "5" to a "6." Consistent with his refusal to predicate a standard- of-care violation strictly on the quantity of opioids prescribed, Petitioner's expert witness admitted, "counting pills is not the best way of managing a patient." (Tr., p. 43.) But his standard-of-care analysis regarding Respondent's care for D. M. includes the quantity of pills in the context of patient complaints, the underlying diagnosis, and the existence of alternative means of treating the patient's pain, such as a fentanyl patch. (Tr., pp. 40 and 45.) The standard-of-care violation for D. M. relies on this broader record of Respondent's care for this patient, not on the following testimony of Petitioner's expert: "So, the whole case boils down to, you shouldn't be putting patients with fibromyalgia on this much medication." (Tr., p. 44.) Neither in May 2007 nor three and one-half years later at the hearing did Respondent have any idea why he dramatically increased D. M.'s roxicodone prescription on May 24. To the extent that Respondent claimed a "mere" mistake, his explanation would have carried more weight, if he had not also offered his well-worn financial argument that the patient could not afford the additional cost of the long-acting opioid, Oxycontin®. This argument did not apply to D. M., who was already paying for Oxycontin® each month. This makeshift defense, the unjustified increase of opioids, the mistaken recollection of the substitution of roxicodone for Oxycontin®, and the failure to recall when Respondent's treatment of this patient started combine to make Respondent's brief treatment of D. M. appear random and chaotic. On these facts, Respondent's prescription of opioids was inappropriate, excessive, and otherwise unjustified. Petitioner proved a medical-records violation and a standard-of-care violation. R. H. From January 29, 2007, through July 7, 2009, Respondent prescribed to R. H. a monthly regime of 30-mg roxicodone and 10/235 Norco®. For January 29 and March 2, the dosages were 60 roxicodone pills and 240 Norco® pills. On March 27, Respondent raised the roxicodone prescription to 90 pills. This prescription continued through visits on April 24, May 22, June 20, and July 18. On August 2, which was only two weeks after the preceding office visit, Respondent doubled the number of roxicodone pills to 180. On September 28, Respondent increased the roxicodone by one-third, from 180 to 240 pills. On November 30, Respondent increased the roxicodone prescription to 300 roxicodone pills and, for the first time, changed the Norco® prescription, raising it from 240 pills to 300 pills. Respondent maintained these prescriptions through 14 "monthly" visits in 2008--actually, 13, as the last is on December 23, 2008--and visits on January 21 and February 17, 2009. On March 17, Respondent decreased the Norco® to 280 pills. On the final visit, on July 7, 2009, Respondent decreased the roxicodone to 270 pills and Norco® to 240 pills. Respondent first saw R. H. in 2001 due to failed-back syndrome following a car accident three or four years earlier and a micro-discectomy of L5/S1, which had resulted in additional complications. R. H. had been wheelchair-bound for eight months and was learning to walk again; she was in intractable pain. A psychiatrist later diagnosed her with severe anxiety disorder and post-traumatic stress disorder. R. H. visited the Pain Management Center after a referral by her physician, who was no longer comfortable prescribing her Vicodin ES®. R. H. disclosed in her 2001 initial office visit that she had recently had another automobile accident, for which she had been charged for driving under the influence. R. H. reported that epidural injections had failed to control her pain, and she had gained 50 pounds in the past couple of years. An unsettling consultation note is in R. H.'s medical records. On January 31, 2001, Anjan K. Ghosh, M.D., of the Anesthesia Pain Care Consultants, Inc., saw R. H. in consultation. Dr. Ghosh concluded the R. H. suffered from lumbar post-laminectomy pain syndrome "with conflicting physical signs on examination," mechanical lumbar axial pain, severe anxiety disorder, and gastroesophagael reflux disease. In a detailed plan of treatment, Dr. Ghosh proposed a caudal catheter neuroplasty and nerve root decompression to treat R. H.'s recurrent lumbar radiculitis. Based evidently in part on an adverse surgical experience, R. H. refused this treatment, saying, "the reason I was sent to see you [was] for only pain medication." After Dr. Ghosh explained that he would continue her Vicodin ES® only for two weeks, R. H. asked again if she could consider the surgical intervention later, but, for now, obtain prescriptions for an opioid regimen, which Dr. Ghosh declined to do. R. H. was an unusual patient because, even though she was in her mid-thirties when she first saw Respondent, she often brought her mother, who, according to Respondent, "doled" out her prescribed opioids. (Tr., p. 242.) In contradictory statements, Respondent testified: "She did well. She was able to function. She lost jobs constantly." (Tr., p. 243.) Respondent's testimony about this patient is surprisingly brief based on the lengthy two and one-half years that he saw her, as covered by this case; the dramatic increase in roxicodone from 1800 mg monthly to 9000 mg monthly, with a smaller increase in Norco®; and the instability of the patient, as reflected by her dogged pursuit of opioids, her DUI arrest five or six years earlier, and the role of her mother as the gatekeeper to her prescribed opioids. Petitioner's expert witness noted that the March 27, 2007, medical note, in which Respondent raised the roxicodone from 60 pills to 90 pills monthly, contained no explanation for the increase. Likewise, Petitioner's expert found no justification in the medical records for the doubling of the roxicodone from 90 pills to 180 pills monthly in August 2007, the increase from 180 pills to 240 pills monthly two months later, or the increase of the Norco® from 240 pills to 300 pills monthly one month later. Petitioner's expert noted these increases in opioids were not accompanied by physical exams, physical findings, or any consideration of alternative therapies, such as nonsteroidal anti-inflammatory drugs. Respondent's medical records reveal a "4" for reported pain on March 1, 2007, but no vitals, and no pain report or vitals on March 27, 2007, when Respondent hiked the roxicodone by 50% and prescribed Neurontin®, which Respondent testified at the hearing he did not "even know what it is." (Tr., p. 240- 41.) The medical note for April 24, 2007, consists of a few scribbled lines without any vitals or pain report. On May 22 and June 20, 2007, the medical records contain vitals, but no pain report. Finally, on July 18, the medical note contains a pain report, but it is still a "4." Two weeks later, when Respondent doubled the roxicodone from 90 to 180 pills monthly, the medical note reflects that the pain is still only a "4." During this period of time, R. H. had had a molar surgically removed on April 7, 2007, and had been passing out weekly since that event. In mid-September 2007, R. H. was admitted to a local hospital one week after an automobile accident. In the followup to the automobile accident, a CT scan of the brain revealed vascular abnormality, which required a followup hospital admission that did not reveal anything especially serious. However, the accident had resulted in some upper extremity pain and some back pain. At the time of the hospital admission in connection with this accident, R. H. admitted only to the use of Soma® and Valium®, as well as occasional marijuana, but not the extensive opioids that Respondent was prescribing. All of this information is in Respondent's medical records. R. H. reported a pain level of "8" on the September 28 medical note, despite the large increase in roxicodone prescribed two months earlier. If there was a discussion of the recent automobile accident, it does not emerge from the nearly illegible notes, and Respondent did not testify to any analysis of the effect of this recent accident. At this time, Respondent increased the roxicodone by 50%--from 180 pills to 240 pills monthly. On November 1, 2007, the medical note reveals that R. H. reported pain at a level of "5." On a patient questionnaire, R. H. reported that pain had not interfered at all in the past month with her mood, walking, sleeping, concentrating, appetite, work, or relationships, and she denied any side effects. Despite this information, one month later, on November 30, with the pain reported at only a "4," Respondent increased the roxicodone by 60 pills monthly. While Respondent maintained this prescription through 2008, R. H. reported pain at only a "4." On February 17, 2009, in a medical review, Respondent noted that R. H.'s urine had tested positive for THC. This note records R. H.'s difficulty in keeping a job. This note describes a treatment plan to continue the present pain medications, possibly taper benzodiazepines, and continue to refer R. H. to psychotherapy. There is little connection between the medical records--most notably, the self-reported pain levels--and the amount of opioids that Respondent prescribed. Given the obvious difficulties that this patient was experiencing and the large increases in opioids that Respondent prescribed her, the treatment plan described in the preceding paragraph was insufficient. These facts do not depict merely a failure of the medical records to justify the course of treatment. Even without regard to the single indication of marijuana use, R. H. was a substance abuser who lied to health-care providers about what she was taking and required her mother to control her access to the opioids that Respondent prescribed. Respondent's treatment "plan" was to give R. H. exactly what she wanted, including one drug with which Respondent was completely unfamiliar. This patient needed help, and Respondent, for two and one-half years, failed to practice in accordance with the applicable standard of care by continuing to supply her with an increasing supply of opioids--essentially, failing to treat her. Under these circumstances, Respondent's opioid prescriptions were inappropriate, excessive, and otherwise unjustified. Petitioner proved a medical-records violation and a standard-of-care violation. K. L. From March 15, 2007, through July 16, 2009, Respondent prescribed to K. L. a monthly regime of mostly 30-mg roxicodone with occasional 10/325 Percocet®, 80-mg Oxycontin®, and 15-mg roxicodone. On March 15, 2007, Respondent prescribed 420 30-mg roxicodone pills (all roxicodone prescriptions for K. L. are for 30 mg unless otherwise stated) and 120 Percocet® pills. This prescription continued through office visits on April 11, May 9, and June 6, at which time Respondent dropped the Percocet® prescription. From July 2, 2007, through November 14, 2007, which covers five and one-half months, Respondent prescribed "monthly"--on six occasions--420 pills of roxicodone. On December 12, 2007, Respondent reduced the prescription to 400 pills of roxicodone, but added 60 Percocet® pills. This prescription continued through office visits on January 8, 2008, and February 7. On March 5, 2008, Respondent dropped the Percocet® from the prescription, but raised the roxicodone to 420 pills. This prescription continued until January 5, 2009--so as to cover 11 months with 12 "monthly" prescriptions. On January 30, 2009, Respondent reduced the roxicodone from 420 pills to 360 pills. On February 26, 2009, Respondent effectively increased the prescription by reducing the 30-mg roxicodone from 360 pills to 280 pills, but adding 200 pills of 15-mg roxicodone. On March 5 and 6, 2009, Respondent prescribed 90 roxicodone pills, 30 Percocet® pills, and 26 Oxycontin® pills (in two prescriptions). Four days later, on March 10, Respondent prescribed 120 roxicodone pills. Fifteen days later, on March 26, Respondent prescribed 390 roxicodone pills. On April 22, Respondent prescribed 360 roxicodone pills. On May 20, he prescribed 330 roxicodone pills. And on June 17 and July 16, 2009, Respondent prescribed 300 roxicodone pills each office visit. At the initial visit, K. L. informed Respondent that he had been seeing another pain physician, Frederick Swartz, M.D., but was required to visit every three weeks and found the office hours inconvenient. One may safely infer that the frequency of visits was part of Dr. Swartz's attempt to restrict K. L.'s aberrant behavior. Dr. Swartz had prescribed, every three weeks, 84 Percocet®, 284 roxicodone, and 84 Xanax®. On a monthly basis, the 84 pills translate to about 121 pills, and the 284 pills translate to about 410 pills. Respondent's initial prescription thus maintained the levels of Percocet® and roxicodone that the preceding physician had prescribed. During the initial interview, K. L. advised Respondent that he had suffered orthopedic injuries from being struck in the face with a baseball bat many years earlier, as well as two automobile accidents more recently. Having previously worked as a personal trainer, according to the notes, K. L. "works now in the New York State Business." The meaning of this statement remains known only to its author, but does not necessarily mean that K. L. was an out-of-state patient. K. L. informed Respondent that he obtained adequate pain relief from the 14 roxicodone that he took daily. K. L. stated that he had tried Oxycontin® for a couple of days, but did not like it due to cognitive impairment. His only surgical history involved the repair of the eye socket following the baseball bat injury. K. L. rated his pain as a "6." Respondent testified that, after four months, he eliminated the Percocet® because there was no need for K. L. to be taking two short-acting opioids simultaneously, and Respondent was concerned about potential acetaminophen toxicity. These were prudent concerns. A major issue in this patient's treatment developed when, on March 15, 2007, he took a urinalysis, and it tested positive for opiates, in addition to the oxycodone and benzodiazepine that Respondent had been taking, as prescribed. The test results distinguish between the oxycodone present in the roxicodone and Percocet® that had been prescribed for K. L., and other, nonprescribed opiates, such as heroin and codeine. K. L. failed subsequent urinalyses administered by Respondent. On May 9, 2007, his urine tested positive for oxycodone and other opiates, but not benzodiazepines. On February 7, 2008, January 30, 2009, and February 26, 2009, K. L.'s urine tested positive for oxycodone, morphine (another opiate that evidently is disclosed separately from opiates), and benzodiazepines. Respondent's contradictory testimony confirms his mishandling of the patient. Initially, Respondent testified that he had concluded, when K. L.'s urinalyses first disclosed opiates, that K. L. suffered from some sort of rare condition in which the liver failed to metabolize the oxycodone and caused the urinalyses to detect the oxycodone as other opiates. This explanation is discredited because Respondent failed to order additional lab work on liver function at the time and failed generally to proceed to rule out or otherwise deal with any liver problems. Respondent later admitted, in cross- examination, that he was not concerned about K. L.'s liver in 2007 (Tr., p. 339.), but only became concerned about it in 2009. (Tr., p. 340.) The actual explanation for the failed urinalyses was K. L.'s consumption of other opiates that he was not disclosing to Respondent. And Respondent was aware of this aberrant behavior. Undermining his testimony about a later suspicion of liver dysfunction, Respondent, reading from a medical note dated January 30, 2009, testified: "I even put [K. L.] on probation because I thought he was lying to me." Obviously, he would not have put a patient on probation for impaired liver function. Even if Respondent were telling the truth that he did not realize, until January 30, 2009, that K. L. had been lying to him about other opiate use--which he was not--two facts nonetheless undermine Respondent's attempted explanations. First, from March 15, 2007, through January 30, 2009, Respondent prescribed to K. L. over 10,000 roxicodone pills. After Respondent claimed to have concluded that K. L. was lying about other opiate use, Respondent prescribed, from February 26, 2009, through July 16, 2009, over 2000 more roxicodone pills plus 200 15-mg roxicodone pills. As was the case with R. H., these facts do not depict merely a failure of the medical records to justify the course of treatment. K. L. is also a substance abuser, engaging in the especially dangerous behavior of combining his prescribed opioids with unprescribed opioids. For almost two years, Respondent joined K. L. in an elaborate rationalization process designed to avoid confronting the patient's urgent problem. K. L. needed help, and Respondent, for two years, failed to practice in accordance with the applicable standard of care by continuing to supply him with an increasing supply of opioids-- essentially, failing to treat him. Under these circumstances, Respondent's opioid prescriptions were inappropriate, excessive, and otherwise unjustified. Petitioner proved a medical-records violation and a standard-of-care violation. J. K. From May 22, 2007, through July 27, 2009, Respondent prescribed to J. K. a monthly regime of 30-mg roxicodone plus Oxyfast® occasionally. (All roxicodone prescriptions for J. K. are for 30 mg.) On May 22, 2007, Respondent provided J. K. with two prescriptions of 120 roxicodone pills each. On June 19, Respondent wrote J. K. two roxicodone prescriptions--one for 150 pills and one for 170 pills. On July 16, Respondent wrote J. K. a prescription for 150 roxicodone pills, a prescription for 120 roxicodone pills, and one bottle of Oxyfast®. On August 13, Respondent wrote J. K. a prescription for 300 roxicodone pills, five roxicodone pills, and two bottles of Oxyfast®. On September 10, Respondent wrote J. K. a prescriptions for 295 roxicodone pills, five roxicodone pills, and one bottle of Oxyfast®. On October 8, Respondent reduced the numbers of roxicodone pills by giving J. K. prescriptions for 190 roxicodone pills, 140 roxicodone pills, ten roxicodone pills, and one bottle of Oxyfast®. On November 2, Respondent maintained these prescriptions, dropping only the prescription for ten roxicodone pills. But, three days later, Respondent gave J. K. a prescription for ten roxicodone pills. On December 3, 2007, Respondent greatly increased the prescription, raising it to 410 roxicodone pills and two bottles of Oxyfast®. On January 4, 2008, Respondent reduced the prescription to 330 roxicodone pills in one prescription and ten roxicodone pills in the other, as well as two bottles of Oxyfast®. Again, on February 1, 2008, Respondent increased the prescription, raising it to 380 roxicodone pills, but dropping the Oxyfast®. Respondent repeated this prescription on February 28 and raised it to 410 roxicodone pills on March 28. Respondent lowered it to 380 roxicodone pills on May 22. Then, on May 22, June 19, July 17, and August 13, Respondent prescribed 450 roxicodone pills each month. Respondent did not see J. K. for the next five months. On January 19, 2009, Respondent gave J. K. separate prescriptions of 200 and 250 roxicodone pills. On February 13, Respondent issued J. K. a single prescription for 450 roxicodone pills. On March 12, Respondent issued five roxicodone prescriptions for 200 pills, 100 pills, 100 pills, 50 pills, and 70 pills--for a total of 520 pills. Six days later, on March 18, Respondent gave J. K. another roxicodone prescription--this time for 30 pills. On April 7, Respondent gave J. K. two roxicodone prescriptions--one for 100 pills and one for 250 pills. Six days later, on April 13, Respondent gave J. K. two more roxicodone prescriptions--one for 200 pills and one for 50 pills. On May 5, Respondent gave J. K. a roxicodone prescription for 250 pills. On June 1, Respondent gave J. K. roxicodone prescriptions for 250 and 200 pills each. And on June 29 and July 27, Respondent gave J. K. roxicodone prescriptions for 450 pills each. J. K. had been a semi-professional hockey player who retired prematurely due to back pain. He exacerbated his back problems when he was involved in an automobile accident on April 19, 2004. On July 16, 2007, J. K. reported a pain level of "7," but this increased to a "9" on August 13, 2007. At this time, Respondent increased the roxicodone prescription. However, the medical records do not reveal escalating pain reports during the first half of 2008 when Respondent twice ramped up the roxicodone levels. The complaints of Petitioner's expert witness are that Respondent prescribed short-acting opioids for chronic pain, and Respondent prescribed excessive opioids for the injury at issue, which Petitioner's expert first identified as the older hockey injury, not the newer injury from the car wreck. These complaints appear ungrounded. As noted above, this record fails to reveal the superiority of long-acting opioids over short-acting opioids for the treatment of chronic pain, and Petitioner's expert acknowledged that a practitioner must sometimes prescribe roxicodone, rather than a long-acting opioid, such as Oxycontin®, due to cost considerations. Obviously, in suggesting that J. K.'s pain was disproportionate to his injury, Petitioner's expert would have enjoyed greater credibility if he had not first based his testimony on the much- older hockey injury to the face, rather than the newer injuries to the back from the automobile accident. In her cross-examination of Respondent, Petitioner's counsel tried to suggest that Respondent violated the standard of care by resuming the roxicodone prescription, after a five- month hiatus in visits between August 2008 and January 2009. However, Respondent first confirmed that J. K. was positive for oxycodone and, thus, not opioid-naïve. Respondent also explained that J. K. had seen a doctor in New Jersey while he was there visiting his mother. Essentially, for J. K., the standard-of-care opinion of Petitioner's expert witness is based entirely on inadequate medical records. The expert noted correctly that Respondent's medical records, which span two years, lack assessments, diagnoses, and treatment plans. At times, the medical records fail to support changes in medications. But Petitioner has failed to prove that Respondent's treatment of J. K. itself violates the standard of care because there is some correspondence between pain reports and prescription quantities. Petitioner proved a medical-records violation, but not a standard-of-care violation. K. G. From June 19, 2007, through July 27, 2009, Respondent prescribed to K. G. a monthly regime of 30-mg roxicodone pills. (All roxicodone prescriptions to K. G. are for 30-mg doses, unless otherwise indicated.) For the first four months, Respondent prescribed 300 roxicodone pills monthly. For the next four months, Respondent prescribed 280 pills monthly. For the next year, Respondent did not see K. G. When K. G. returned on December 19, 2008, Respondent prescribed 280 roxicodone pills, which he maintained for the next two months' prescriptions. On April 6, 2009, Respondent maintained the prescription at 160 30-mg roxicodone pills plus 240 15-mg roxicodone pills, which is the equivalent of 280 30-mg pills. On April 30, 2009, Respondent provided two prescriptions of 160 and 120 roxicodone pills, and, on May 26, June 24, and July 27, 2009, Respondent prescribed 280 roxicodone pills each month. K. G. presented to Respondent with complaints of lower back pain, probably resulting from two automobile accidents. An MRI of the lumbar spine showed a herniated disc at L5/S1, causing impingement of the right and left S1 nerve root, and a herniated disc at L4/L5. Dr. Deluca, who was no longer practicing, had been prescribing K. G. 120 80-mg Oxycontin® pills and 420 30-mg Oxycontin® pills, presumably monthly. K. G. had been switched to Suboxone®, which is used to withdraw a patient from opioids, but K. G. admitted to buying and using Oxycontin® on the street. The initial note contains a treatment plan. Claiming a pain level of "9," K. G. asked to resume Oxycontin®, but Respondent declined, based in part of K. G.'s history of high intake of opiates. Respondent instead suggested interventional pain management. A urinalysis administered on the initial visit was negative as to "everything." Respondent then prescribed ten roxicodone pills daily, perhaps revealing a belief that K. G. was not, in fact, opioid-naïve at the time. On K. G.'s next visit, on July 17, 2007, he tested positive for THC. In a medical note dated October 22, 2007, Respondent noted that K. G. had not seen the orthopedist, to whom he had referred him. Respondent found K. G. difficult to manage because he traveled a lot, working as a market maker for stocks. K. G. took Suboxone®, but only to avoid withdrawal symptoms from interruptions in his roxicodone regime while he was in other countries, where he presumably could not take his roxicodone. On January 4, 2008, Respondent placed K. G. on probation due to unspecified aberrations in behavior. K. G. promptly discontinued seeing Respondent for over ten months between January 4 and November 21, 2008. On his return, K. G. again tested positive for THC. Respondent testified that he counseled him not to continue to use marijuana, but his records do not document this fact. Respondent continued treating K. G. for another eight months without administering another urinalysis. Again, the medical records reveal no assessment, diagnosis, or treatment plan. Petitioner's expert witness pursued some false trails in trying to establish a standard-of-care violation. He complained about a split prescription on April 30, 2009, but there were only three such prescriptions over two years, and this record fails to reveal a sinister purpose in splitting prescriptions. About the worst thing that Petitioner's expert has to say about the practice is that he is "not sure of the purpose for that." (Tr., p. 70.) Petitioner's expert witness raised the issue of short-acting versus long-acting opioids, but this has already been addressed. Petitioner's expert objected to Respondent's prescription of Xanax® and Soma®, but, as already noted, Petitioner did not plead these matters. Petitioner's expert witness mentioned the polysubstance use of benzodiazepines and oxycodone--both prescribed--with marijuana. Petitioner's expert opined that patients who persist in using marijuana "need to be tapered off their [opioids] and referred for [substance abuse] counseling." (Tr., pp. 72 and 145.) Respondent's expert opined that practitioners are divided in what to do with patients whose aberrant behavior involves exclusively marijuana use. The standard of care as applied to marijuana use is discussed in the Conclusions of Law. Petitioner's expert finds firmer footing when he ties in the other aberrant behavior of K. G., including obtaining Oxycontin® on the street and K. G.'s on-again, off-again misuse of Suboxone® as a opiate-substitute, not as an agent to assist in opiate detoxification. When K. G. ignored Respondent's referral to an orthopedist, K. G. blatantly ignored Respondent's lone attempt to initiate a reexamination of the patient's underlying condition. There were one or more unspecified aberrant behaviors, and, when Respondent finally placed the patient on probation, K. G. quit seeing Respondent for ten months: on his return, he promptly tested positive for marijuana again. These facts are the grounds of the standard-of-care violation. As was the case with R. H. and K. L., so it is with K. G. By continuing to prescribe opioids and not treating the underlying condition, or tapering him off and then dismissing K. G. as a patient, if he refused to stop his aberrant behavior, Respondent essentially deprived K. G. of the treatment that he required. Petitioner proved a medical-records violation and standard-of-care violation. D. D. From June 30, 2008, through June 3, 2009, Respondent prescribed to D. D. a monthly regime of 290 30-mg roxicodone pills. And, in this case, a one-year span produced only 12 prescriptions. At his initial visit on June 30 or July 1, 2008, D. D., a diabetic in his 50s, presented with pain in both knees. His left knee had been replaced two years earlier and was doing well, but he was awaiting replacement of his right knee. D. D. had an abscess at L5/S1. He was on SSI disability. Although taking 30-mg and 15-mg roxicodone, D. D. wanted to get off the 30-mg pills because he had no insurance. Obese at 192 pounds, D. D. reported his pain to be an "8." The treatment plan involved converting D. D.'s 15-mg roxicodone pills for 30-mg roxicodone pills, despite his interest in dropping the 30-mg pills, but Respondent maintained the same dosage as had been prescribed by the preceding physician. Otherwise, the treatment plan consisted of discussing the rules of the Pain Management Center. Petitioner's expert witness complimented Respondent on his initial medical record: he called it a "well presented medical record, a good history there. I think this is an appropriate medical record." (Tr., p. 85.) And it is. Petitioner's expert also testified that the patient required opiate management. Laboring under a misunderstanding as to the amount of roxicodone that Respondent had prescribed on the first visit, Petitioner's expert was alarmed by what he thought had been a doubling on the second visit; in fact, the quantity had remained unchanged. In this case, given the short time of treatment and the extensive medical difficulties of the patient, whom Respondent described aptly as "one of the saddest patients I have" (Tr., p. 230), Petitioner's expert lacked support in the record for his opinion that Respondent was required to address eliminating pain medications from D. D.'s life. D. D. was a low-functioning person when he presented to Respondent, and the standard of care did not require, within one year, that Respondent either get D. D. off opioids or substantially improve his function. However, toward the end of the treatment period, D. D. enjoyed greater functionality, as he was able to help raise his grandson. Petitioner failed to prove a medical-records violation or a standard-of-care violation. J. M. From October 1, 2007, through July 3, 2009, Respondent prescribed J. M. a monthly regime of 30-mg roxicodone pills and Oxyfast bottles. (All roxicodone prescriptions to J. M. are for 30-mg doses, unless otherwise indicated.) On October 1, 2007, Respondent prescribed 240 roxicodone pills and one bottle of Oxyfast.® On October 23, Respondent maintained the roxicodone, but doubled the Oxyfast® to two bottles. Respondent maintained this prescription level the next month. On December 21, Respondent essentially maintained the same prescription level by prescribing 105 30-mg roxicodone pills and 273 15-mg roxicodone pills, as well as two bottles of Oxyfast.® On January 18, 2008, Respondent again maintained the same prescription level by prescribing 70 30-gm roxicodone pills and 340 15-mg roxicodone pills, plus two bottles of Oxyfast.® But four days later, Respondent prescribed another 70 roxicodone pills. On February 18, Respondent prescribed 240 roxicodone pills in two prescriptions--one for 70 pills and one for 170 pills--but no Oxyfast.® On March 25, Respondent prescribed 240 roxicodone pills--in separate prescriptions of 110 and 130 pills--and two bottles of Oxyfast®. Respondent repeated this prescription, but with a single roxicodone prescription each month, for the next nine months. The only exceptions were split prescriptions of 140 pills each on June 17 and the discontinuation of visits between June 17 and September 8. On February 24, 2009, Respondent reduced the prescription to 60 pills of 15-mg roxicodone. On March 23, he raised it to 300 pills of roxicodone--split into prescriptions of 120 pills and 180 pills--and two bottles of Oxyfast.® On April 17, Respondent prescribed two bottles of Oxyfast®, and, on April 23, Respondent prescribed 70 roxicodone pills. On May 15 and June 10, 2009, Respondent prescribed 300 roxicodone pills--divided into two prescriptions of equal amounts--and two bottles of Oxyfast®. On July 3, 2009, Respondent prescribed 300 roxicodone pills--divided into prescriptions of 80 and 220 pills--and two bottles of Oxyfast®. In the initial visit in 2002, J. M. presented as a 32-year-old male with lower back pain. He reported that he had injured his back a few months earlier picking up an object. Unable to lift, J. M. had had to quit working as a gardener. He had been taking four or five Percocet 10/325's daily. The treatment plan, which was prepared by Respondent, was to help J. M. quit smoking tobacco and convert him from Percocet, with the potential acetaminophen toxicity, to roxicodone. J. M. told Respondent that his girlfriend had let him try some of her Xanax®, which had helped him with spasms and sleeping, so Respondent prescribed that too. They also discussed that J. M. should exercise his COBRA rights on his insurance because he was going to get some evaluations, as well as epidural injections. An MRI of the lumbar spine performed on February 6, 2008, revealed multilevel central disc herniations at L2/L3, L3/L4, L4/L5, and L5/S1 with annular tears in the herniations at L3/L4, L4/L5, and L5/S1. The MRI disclosed mild spinal stenosis at L4/L5. None of the ten patients involved in this case displayed the same extent of objective bases for the pain of which he or she complained. In August 2007, while being seen by Dr. Morency at the Pain Management Center, J. M. expressed a desire to be seen by a different physician, but the medical record fails to reveal why. On October 1, 2007, when first treating J. M., Respondent continued the level of opioids that Dr. Morency had been prescribing. Respondent prescribed Oxyfast® with roxicodone because the former, as a liquid, has a faster onset than the pill, which can take 45 minutes to take effect. Respondent testified that he doubled the Oxyfast® on October 23 because the pain was worse. But, according to the medical records, J. M. reported pain of "5" on October 1, 2007, and, three weeks later, reported pain of only "3." On July 3, 2009, a urinalysis revealed THC. Respondent discussed with J. M. his aberrant behavior and placed him on probation, warning him not to test positive for marijuana again. However, J. M. had tested positive for marijuana on April 17, 2006, August 7, 2007, and October 23, 2007--each time he had been tested. Respondent did not test J. M. again for nearly two years. Petitioner's expert faulted Respondent for his handling, or lack of handling, of J. M.'s apparently ongoing marijuana use during treatment. This is addressed in the Conclusions of Law. Petitioner's expert witness faulted Respondent for using short-acting opioids rather than long-acting opioids, but this has been dealt with already. Except for the doubling of the Oxyfast® early in the period of treatment, the medical records fail to establish a correspondence between pain reports and prescription levels of roxicodone on three occasions: the two months during which Respondent supplemented the roxicodone prescription with 70 pills and the 25% increase in roxicodone in early 2009. The medical records lack assessments, diagnoses, and treatment plans. In particular, the medical records are deficient because they do not justify the three increases in prescribed opioids. But there is insufficient evidence of a standard-of- care violation as to J. M. There is insufficient evidence of aberrant behavior that would require Respondent to taper off J. M. from pain medications--despite well-documented sources of pain--while he obtained counseling to help him stop using marijuana. And the three instances in which increased prescriptions were not justified in the medical records prove a medical-records violation, not a standard-of-care violation, as discussed in the Conclusions of Law. No other evidence in the record establishes a lack of justification for the prescribed opioids. Petitioner proved a medical-records violation, but not a standard-of-care violation. M. L. From April 26, 2007, through March 3, 2009, Respondent prescribed to M. L. a monthly regime of 30-mg roxicodone pills, except for a single prescription of oxycodone and two prescriptions of Percocet® 10/325. (All roxicodone prescriptions to M. L. are for 30-mg doses.) On April 26, 2007, Respondent prescribed 440 mg of roxicodone pills in two prescriptions--one for 200 pills and one for 240 pills. Respondent repeated this prescription monthly for seven months--eight times--when, on December 6, 2007, he raised it to 540 mg in two prescriptions--one for 290 pills and one for 250 pills. Starting January 8, 2008, Respondent returned to his initial pattern of prescribing 440 pills of roxicodone in two prescriptions. This continued through 2008--again, counting January 8, this amounted to 13 prescriptions, not 12, over the year. Respondent continued this prescription pattern on January 6 and February 2--the latter incorporating 40 15-mg roxicodone pills to achieve the same total prescription in dosage. On March 3, 2009, Respondent prescribed 150 roxicodone pills, 210 5-mg oxycodone pills, and 210 Percocet® 10/325 pills. In 1999, David Buchalter, M.D., referred M. L. to the Pain Management Center with a report stating that an MRI suggested that the patient had a small herniated disc at C3/C4, a mild disc bulge at C4/C5, and degenerative disc space narrowing at C5/C6. By the time that Respondent saw M. L., he had been complaining of neck and lower back pain for many years. M. L. could not afford Oxycontin®, but a urinalysis confirmed that he was taking his prescribed short-acting opioids. M. L. had been seen by the Pain Management Center for several years, and he had never exhibited aberrant behavior. Nothing stands out in the record concerning the care received by M. L., although, again, two years of medical records contain no assessment, diagnosis, or treatment plan. Petitioner proved a medical-records violation, but not a standard-of-care violation. M. P. From February 12, 2007, through July 7, 2009, Respondent prescribed to M. P. a monthly regime of Oxycontin and methadone initially and, later, mostly roxicodone. (All roxicodone prescriptions for M. P. are for 30 mg, unless otherwise indicated.) M. P. had been seen by the Pain Management Center since at least 2002. He was operating a forklift in 1999 when boxes fell on him, injuring his neck. An MRI revealed a ruptured disk at C3/C4, a disc bulge at C4/C5, and degenerative disc disease at C5/C6. At the time of the office visit, M. P. was still employed driving a forklift, but was taking 120 mg of Oxycontin® daily. Despite a medical record dated January 5, 2006, stating that M. P. could not afford Oxycontin®, he was still on this relatively expensive, long-acting opioid at the start of the period in question. During his years of treatment at the Pain Management Center, M. P. had never displayed any aberrant behavior, as periodic urinalyses revealed that M. P. was taking his prescribed opioids and nothing else. The medical records during the period in question contain no patient assessments or treatment plans, nor do they explain the switching of medications. Of particular interest, as to the standard of care, is the relatively long period that Respondent prescribed two long-acting opioids, methadone and Oxycontin®. As Petitioner's expert testified, such overlapping is appropriate during a dosage-transition phase, as the practitioner transitions the patient from one such opioid to another. But here, Respondent prescribed methadone and Oxycontin for five months. At the end of this period, Respondent discontinued the Oxycontin®, but there is no constant tapering off of Oxycontin® during this period. From February to July 2007, the monthly prescriptions for Oxycontin® are for 14,400 mg, 14,400 mg, 14,400 mg, 14,400 mg, 0 mg, and 4800 mg. As noted above, methadone is difficult to use for analgesic purposes. Doubtlessly, this difficulty is increased by adding another long-acting opioid, even if its half life is much shorter than the half-life of methadone. But this is really all that Petitioner presents for a standard-of-care violation. Although it is a close question, Petitioner's evidence fails to convince that five months' dual prescribing of two long-acting opioids was inappropriate, excessive, or unjustified. Petitioner's expert questioned the amount of roxicodone prescribed, in conjunction with methadone, for back pain. This criticism was less well-founded, as Respondent eventually discontinued the methadone also. Additionally, M. P. tended to report high pain levels during the period in question. Again, during the two and one-half years of relevant treatment, the medical records fail to include an assessment, diagnosis, or treatment plan, including any guide to the transitioning of the patient off of two long-acting opioids. Petitioner proved a medical-records violation, but not a standard-of-care violation.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order finding Respondent guilty of nine counts of medical-records violations and four counts of standard-of-care violations and imposing $107,500 in administrative fines, four years' suspension from the practice of medicine, 200 hours' community service, six years' probation after completion of the suspension, restrictions upon Respondent's license after it is reinstated, coursework, and costs. DONE AND ENTERED this 23rd day of June, 2011, in Tallahassee, Leon County, Florida. S ROBERT E. MEALE 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 23rd day of June, 2011. COPIES FURNISHED: Shirley L. Bates, Esquire Grace Kim, Esquire Department of Health 4052 Bald Cypress Way, Bin C65 Tallahassee, Florida 32399-1701 Sean Michael Ellsworth, Esquire Ellsworth Law Firm, P.A. 1501 Collins Avenue, Suite 208 Miami Beach, Florida 33139 Renee Alsobrook, Acting General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Larry McPherson, Jr., Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399
The Issue The issues are whether Respondent failed to maintain an accurate medication record relating to narcotic medications in violation of Section 400.419(1)(b), Florida Statutes, and Rule 58A-5.0185(3)(b), Florida Administrative Code; and if so, what penalty should be imposed.
Findings Of Fact Petitioner has authority to license assisted living facilities (ALFs) and the duty to enforce all statutes and rules governing such facilities. Respondent is a licensed ALF with a total capacity for 35 residents. Respondent's License No. AL5888 is effective March 20, 2002, through March 19, 2004. On January 31, 2002, Petitioner completed a biennial survey of Respondent's facility. During the survey, Petitioner's staff observed Respondent's staff administering medication to six residents who needed medication assistance. Resident No. 6 received a narcotic medication, in tablet form, that she was supposed to take by mouth three times daily, as needed, for pain. The medication is addictive and may be obtained only by prescription. The prescription bottle at issue here indicated that it was filled on January 21, 2002, with 100 tablets. There is no other evidence regarding the number of tablets in the bottle when it arrived at Respondent's facility. Respondent did not count the tablets in the bottle upon receiving it from the pharmacy. Resident 6's MOR showed that she received the narcotic tablet three times daily, everyday, with no missed doses during the time period at issue here. According to the MOR, Resident 6 received a total of 32 doses of the medication beginning January 21, 2002, at 7:00 a.m. through January 31, 2002, at 12:25 p.m. However, the bottle contained only 54 tablets as of January 31, 2002, at 12.25 p.m. Respondent's staff could not explain or account for the 14 missing narcotic tablets. Under cover of a letter dated February 12, 2002, Petitioner advised Respondent that the biennial survey had identified a Class II deficiency relative to Resident 6's medication administration. The letter requested Respondent to file a plan of correction within ten days. Resident 6's narcotic medication was refilled on February 19, 2002, with 100 tablets. As of March 8, 2002, Resident 6 had 51 pills remaining in the new prescription bottle. On March 8, 2002, Petitioner's staff conducted a follow-up visit to Respondent's facility. The count of tablets in Resident 6's narcotic medication prescription bottle, when compared to the MOR, was correct at that time. Under cover of a letter dated March 15, 2002, Petitioner advised Respondent that the previously cited deficiency had been corrected.
Recommendation Based on the foregoing Findings of Facts and Conclusions of Law, it is RECOMMENDED: That Petitioner enter a final order dismissing the Administrative Complaint. DONE AND ENTERED this 10th day of October, 2002, in Tallahassee, Leon County, Florida. SUZANNE F. HOOD 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 10th day of October, 2002. COPIES FURNISHED: Michael O. Mathis, Esquire Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building Three, Suite 3431 Tallahassee, Florida 32308-5403 Alvin L. Peters, Esquire 25 East Eighth Street Panama City, Florida 32401 Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Stop 3 Tallahassee, Florida 32308 Valda Clark Christian, General Counsel Agency for Health Care Administration 2727 Mahan Drive Fort Knox Building, Suite 3431 Tallahassee, Florida 32308
The Issue The issues are whether Petitioner is liable to Respondent for Medicaid reimbursement overpayments, and if so, in what amount.
Findings Of Fact Respondent is the agency charged with administration of the Medicaid program in Florida pursuant to Section 409.907, Florida Statutes. Petitioner provides services to Medicaid beneficiaries under provider No. 1000098-00 pursuant to a contract with Respondent. Under the provider agreement dated March 31, 1997, Petitioner agreed to comply with all local, state and federal laws, rules, regulations, licensure laws, Medicaid bulletins, manuals, handbooks, and statements of policy. The contract also sets forth Petitioner's responsibilities to keep and maintain in a systematic and orderly manner all medical and Medicaid-related records, and to make them available for state and federal audits for five years. Heritage Information Systems, Inc. (Heritage) is and has been a pharmacy audit company since 1980. In 1999, Respondent contracted with Heritage to perform audits of pharmacies enrolled in the Florida Medicaid program. Respondent and Heritage subsequently created a list of violations to be investigated during an audit. The list is based upon provisions in the Florida Statutes and federal Medicaid policies and regulations. The purpose of the list is to guide Heritage in performing its duty during an audit. Heritage conducts its audits based on a standard methodology and protocol. During the course of an audit, Heritage examines a provider's records to determine whether a pharmacy is compliant with all rules and regulations that apply to the pharmacy. Heritage uses an established set of neutral criteria to select pharmacies for participation in an audit. Using these criteria, Heritage selected Petitioner as a candidate for audit. By letter dated January 17, 2000, Heritage advised Petitioner that it would be audited on January 26, 2000. The letter stated as follows in relevant part: The auditor(s) will require access to original hard-copy prescription records, third party signature logs, and, in some cases, pharmacy computer screens relating to a sample of prescription claims billed by your pharmacy between 12/25/1998 and 12/24/1999. Please note that the sample claim may actually be a refill of a prescription originally dispensed prior to the audit period. Because of this, we recommend that you also have the prior twelve months of prescription records available the day of the audit. For your reference, the audit terms are defined in your participating provider agreement and the prescribed drug services handbook. If you have any additional questions prior to the audit, please call Heritage Information Systems, Inc. . . . Between December 25, 1998, and December 24, 1999, Petitioner submitted claims and received payments from the Medicaid program for 7,065 claims. Using an industry standard software application, Heritage selected a random sample of 101 of Petitioner's claims to be analyzed during the audit. In performing the audit, Heritage utilized a methodology similar to that used by auditing agencies who examined Medicaid providers in previous years. During the audit, Heritage identified four areas of noncompliance for Petitioner. First, Heritage requested Petitioner's staff to produce hard-copy prescription records for the 101 sampled claims. Hard-copy prescriptions include those ordered and signed by a physician on a handwritten form and the records created by the pharmacists immediately after receiving verbal authorization from a physician by telephone. In this case, Petitioner could not produce hard-copy prescriptions for five claims. The second area of noncompliance involved unauthorized refills. In seven instances, Petitioner refilled prescriptions more times than the number authorized on the documented prescription. There were no notations on the hard-copy prescriptions or in the pharmacy computer to indicate that the doctors or someone from their office called to increase the number of authorized refills. The third area of noncompliance involved one instance in which Petitioner claimed payment for a "days supply value" that was inconsistent with the quantity and directions on the prescription. The prescription at issue was for sixty tablets with directions for the patient to take the drug once a day, constituting a sixty-day supply of medicine. Petitioner filled this prescription as a thirty-day supply and claimed Medicaid payment accordingly. Respondent did not include this violation in the calculation of overpayment. The fourth area of noncompliance involved a prescription that was refilled 30 days earlier than appropriate with respect to the quantity and directions for use that appeared on the prescription. This was the same prescription referenced above in paragraph twelve. After completing the audit, Heritage completed a final audit report. Said report documents the following: (a) 7,310 claims submitted by Petitioner; (b) $350,639.95 paid by Respondent for all claims; (c) 101 claims in total random sample; (d) $3,839.33 paid by Respondent for claims in total random sample; (e) 13 discrepant claims in random sample; $778.09 paid by Respondent for discrepant claims; 13 documented sanctions in random sample; (h) $724.91 paid by Respondent for documented sanctions in random sample; (i) $52,466.25 as the total calculated overpayment; and (j) $13,798.70 as the amount of the overpayment based on a 95 percent one-sided lower confidence limit. The final audit report also contained a listing of the violations discovered during the audit. The final audit report contained the following comments/notes in relevant part: Five prescriptions could not be found by auditors and could not be found by pharmacist Geiger and technician Daniels either. Many unauthorized refills were noticed. Pharmacy staff stated some information may be on the old computer system that was not functioning because of Y2K problems. Any authorization or documentation that was found on the computer system was accepted. Under cover of a letter dated March 2, 2000, Petitioner furnished Respondent with statements relative to the discrepant claims/documented sanctions signed by several physicians. All of the statements included the following: (a) statements that the doctors had prescribed the medication(s) for their patients; (b) the patient name; (c) the prescription number; (d) a print-out of a computer screen; and (e) opinions that Petitioner would not fill or refill prescriptions without authority and approval. None of these physicians testified at the hearing. By letter dated August 16, 2000, Respondent notified Petitioner of the determination of a Medicaid overpayment in the amount of $13,798.70. The greater weight of the evidence indicates that Petitioner received an overpayment in that amount or more.
Recommendation Based upon the findings of fact and conclusions of law, it is RECOMMENDED: That Respondent enter a final order finding that Petitioner must timely pay Respondent $13,798.70 for Medicaid reimbursement overpayments from December 25, 1998, through December 24, 1999. DONE AND ENTERED this 30th day of January, 2001, in Tallahassee, Leon County, Florida. SUZANNE F. HOOD 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 30th day of January, 2001. COPIES FURNISHED: Melvin H. Fletcher, R.Ph. Corporate Representative Mayhugh Drugs, Inc. 200 South Orange Avenue Green Cove Springs, Florida 32043 L. William Porter, II, Esquire Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3431 Tallahassee, Florida 32308 Sam Power, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3431 Tallahassee, Florida 32308 Julie Gallagher, General Counsel Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3431 Tallahassee, Florida 32308 Ruben J. King-Shaw, Jr., Director Agency for Health Care Administration 2727 Mahan Drive Building 3, Suite 3116 Tallahassee, Florida 32308
Findings Of Fact Respondent, Ben Cohn (Cohn), was at all times material hereto a licensed pharmacist in the State or Florida, having been issued license number 0009536. At all relevant times, Cohn was employed as a pharmacist at Don's Discount Drugs in South Miami, Florida. 1/ In or about October, 1981, Don's Discount Drugs was targeted by the Department of Professional Regulation and the Drug Enforcement Administration for a drug diversion audit of all Schedule II prescription drugs. The impetus for the audit was the quantity of methaqualone tablets, a Schedule II prescription drug, that were being dispensed at the store. The audit revealed no improprieties in the control or accountability of Schedule II prescription drugs at Don's Discount Drugs, but did reveal that during the period from August 4, 1981, through January 6, 1982, Don's Discount Drugs had dispensed 202,404 methaqualone 300 mg. tablets on 4,695 prescriptions. 2/ Of theses Cohn dispensed 118,130 methaqualone tablets on 2,724 prescriptions. The vast majority of these prescriptions were written for 45 tablets. The physicians who wrote the prescriptions which Cohn filled were largely employed by "stress clinics". These clinics actively advertised and solicited patients suffering from stress, and frequently prescribed methaqualone. There is, however, no competent proof that these clinics operated illegally, or that the physicians who wrote the prescriptions at issue in this case failed to do so in the good faith practice of their profession. During the time in question, it was legal in the State of Florida to prescribe and to dispense methaqualone. However, of the approximately 400 community pharmacies in Dade County only 10 would fill methaqualone prescriptions. Cohn knew he was dispensing a controversial drug with a high potential for abuse. Consequently, in filling each of the methaqualone prescriptions in question, as with all Schedule II drug prescriptions, Cohn followed a rigid procedure. As to each prescription, he verified that the person presenting the prescription was the person to whom the prescription was written by requiring a driver's license or others photo identification. Cohn then contacted the United States Department of Justice Drug Enforcement Administration to verify that the prescriber had a current DEA number. Cohn then verified with the prescriber that the prescription had been written for that patient and verified the number of tablets reflected on the prescription. Lastly, Cohn placed that patient's name and address on an index card together with the name of the doctor and the date of the prescription. These cards were maintained in a special file for reference in filling prescriptions to prevent dispensing any Schedule II drugs to the same person as a result of multiple prescriptions issued in too short a time period. All of the prescriptions in question were written by prescribers who were duly licensed by the Florida Board of Medical Examiners. None of the prescriptions in question was written or filled for an excessive number of methaqualone written tablets. 3/ Further, the parties have stipulated that Cohn complied with each of the conditions prescribed by Subsections (a)-(g), Section 893.04(1), Florida Statutes. Notwithstanding the fact that Petitioner offered no proof that any prescription filled by Cohn was not issued by a physician in the good faith practice of his profession, or was otherwise counterindicated, it suggests that Cohn did not act in good faith and in the course of professional practice when he filled the prescriptions. Factors which Petitioner deems important to such conclusion are: (1) the large number of prescriptions issued for the same quantity of drug, (2) the limited number of prescribers, (3) that most prescribers worked at "stress clinics", (4) the sudden influx of patients 18-30 years of age to fill prescriptions, (5) the precounting and prepackaging of methaqualone at the store, (6) the "general tone" of the community in regard to the abuse factor of methaqualone, (7) Cohn's failure to ascertain whether the drug was "for the benefit and welfare" of the patient, and (8) that many of the prescribing physicians maintained their offices outside the general neighborhood of the store. Petitioner's proof was not, however compelling. While the dispensing of 202,404 methaqualone tablets at Don's Discount Drugs between August 4, 1981, and January 6, 1982, appears facially to be a large quantity, Petitioner offered no proof to demonstrate its significance. No evidence was presented comparing the total number of methaqualone prescriptions filled at Don's Discount Drugs to the total number of methaqualone prescriptions filled in Dade County at the time. No evidence was presented comparing the number of methaqualone prescriptions filled at Don's Discount Drugs to the total number of prescriptions filled at that pharmacy. No evidence was presented concerning the statistical significance, if any, of the quantities of methaqualone tablets dispensed at Don's Discount Drugs. In sum, the dispensing of 202,404 methaqualone tablets at Don's Discount Drugs between August 4, 1981, and January 6, 1982, which represents an average of 35 prescriptions filled each day, was not demonstrated to be disproportionate to the legitimate needs of the population of Dade County. While many of the prescribers did maintain their offices outside the pharmacy's neighborhood, and a large number of methaqualone tablets dispensed at Don's Discount Drugs, it is significant that only 10 of 400 community pharmacies in Dade County would fill such prescriptions. Under such circumstances, it would not be unusual for such physicians' patients to travel to fill their prescriptions. Neither would it be unusual to find a large number of prescriptions being filled at the limited number of pharmacies willing to fill them. While Cohn did not ascertain whether the prescriptions were written "for the benefit and welfare" of the patient, or otherwise seek to second guess the attending physician by inquiring about the circumstances or diagnosis that prompted the prescription, he did confirm that the physician was properly licensed and that the physician had issued the prescription to the patient who presented it. The Department offered no credible proof that any physician misappropriately prescribed any drugs in this case. Accordingly, the presumption is that the physicians who wrote the subject prescriptions acted lawfully, and in the good faith practice of their profession. See: Atlantic Coast Line R. Co. v. Mack, 57 So.2d 447 (Fla. 1952). Under such circumstances, it cannot be concluded that Cohn failed to act in good faith and in the course of professional practice when he filled such prescriptions. The remaining factors cited by Petitioner are equally unpersuasive. The fact that the prescriptions were written by a limited number of physicians, most of whom were employed by "stress clinics", was not compelling because there was no showing that such physicians operated improperly. The fact that the store experienced a sudden influx of patients 18-30 years of age was not shown to be pertinent since there was no proof that the prescribing of methaqualone to such age group was counterindicated 4/ The fact that Don's Discount Drugs precounted and prepackaged methaqualone tablets demonstrated only that they anticipated a demand for the product; not any impropriety. Cohn's knowledge of the abuse potential for methaqualone and the procedures he employed to avert such abuse, was addressed in paragraph 6, supra. In rejecting petitioner's contention that Cohn failed to act in good faith and in the course of professional practice, I do not suggest that the factors advanced by Petitioner are not necessarily pertinent to the inquiry. Rather, I conclude that in this case such proof was not persuasive because there was no competent proof that any physician misprescribed or acted other than in the good faith practice of his profession. Such being the proof, it cannot be concluded that Cohn violated a community standard by filling a lawful and proper prescription. Cohn was first licensed as a practicing pharmacist in the State of New York in 1945, and has been practicing in the State of Florida since 1961. He has never been disciplined and has never had an administrative complaint, other than the instant complaint, filed against him regarding his practice of pharmacy.
Recommendation Based on the foregoing Finding of Fact and Conclusions of Law, it is RECOMMENDED: That a Final Order be entered DISMISSING the Administrative Complaint. DONE AND ORDERED this 9th day of September, 1987, in Tallahassee, Florida. WILLIAM J. KENDRICK Hearing Officer Division of Administrative Hearings The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 9th day of September, 1987.
The Issue The issue is whether the Respondent's license as a practical nurse should be disciplined for the violations as set forth in the Administrative Complaint.
Findings Of Fact At all times relevant hereto, Respondent, Deborah Breski, held a license as a practical nurse in the State of Florida, license number 0584471. On August 26, 1990, Ms. Breski was employed at Sunrise Manor Nursing Home, Ft. Pierce, Florida, worked the morning shift on Hoffman A Wing, and was assigned to care for patient G. M. G. M.'s physician had ordered that 20 mg of Morphine be administered orally to G. M. no more often than every 4 hours, as needed for pain. Due to his throat cancer, G.M. had difficulty swallowing. On August 26, 1990, at approximately 2:00 p.m., Respondent signed-out 20 mg Morphine liquid for patient G. M. on this patient's Controlled Drug Record. Respondent subsequently initialed patient G. M.'s Medication Record and Profile to indicate her administration of Morphine liquid to this patient at approximately 2:00 p.m. Respondent charted the administration of 10 cc Morphine [the same as 20 mg] to patient G. M. at approximately 2:00 p.m. on August 26, 1990, on the Nurse's Medication Notes. She did not watch the patient ingest the drug, because it takes him a long time to swallow, and she had other patients who needed their medication. She did not, however, chart the effectiveness of the drug on the patient later in her shift. At approximately 3:15 p.m. on August 26, 1990, Respondent was relieved from her assignment on Hoffman Wing by LPN Michelle Delancy. Ms. Delancy prepared patient G. M.'s 6:00 p.m. dose of Morphine liquid. When she came to the patient she discovered a cup of liquid at the patient's bedside. Nurse Delancy asked G. M. if he had taken his pain medication earlier, and he respondend "no". Ms. Delancy then summoned Mr. Breski to patient G. M.'s room and questioned her as to the cup and its contents. Ms. Breski asked Ms. Delancy what Respondent should do with the unused medication, and Ms. Delancy indicated that it was Ms. Breski's Morphine and that she should take care of it. Ms. Breski then poured the unused Morphine back into patient G. M.'s original prescription bottle, in an effort to allow its reuse, and save the patient expense. The proper procedure for wasting medications such as Morphine is to dispose of the medication in the presence of another nurse, and to obtain that nurse's signature as verification that she had witnessed the wastage. Ms. Delancy did not witness Respondent's "disposal" of patient G. M.'s unused Morphine. The Department does not contend that Ms. Breski improperly took the Morphine herself or gave it to anyone else; it was poured back into the bottle. Ms. Breski did not document patient G. M.'s failure to consume his Morphine liquid, or her disposal of the medication by pouring it back into the prescription bottle; neither did she correct her previous charting. Patient G. M.'s records indicate that he received and ingested his scheduled 2:00 p.m. dose of Morphine. Ms. Breski's failure to observe the patient consume his medication created a potentially harmful situation. The patient G. M. could have taken his medication just prior to receiving his next scheduled dose, and would then have received a double dose of Morphine, which would have exceeded his physician's order. An expert for the Department opined that based upon a review of the evidence presented by Petitioner, Ms. Breski inaccurately and falsely recorded that she had administered medication to a patient when she had not actually done so; that Respondent did administer medication in a negligent manner, by not watching (and therefore ensuring) that the patient took the medication; and she made or filed a false report or record which she knew to be false, by documenting that she had administered the medication to the patient when she had not actually done so.
Recommendation Based upon the foregoing, it is recommended that the Board of Nursing enter a Final Order finding that Deborah Breski has violated Sections 464.018(1)(f) and (h), Florida Statutes, (1989) and Rule 210-10.005(1)(e)(1) and (2), Florida Administrative Code. Respondent should therefore be reprimanded by the Board, fined an administrative fine of $250.00, and placed on probation for a period of one year, subject to the requirement of taking an appropriate continuing education course which includes instruction on the administration, charting and proper means to waste medication. RECOMMENDED in Tallahassee, Leon County, Florida, this 4th day of October, 1991. WILLIAM R. DORSEY 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 4th day of October, 1991. COPIES FURNISHED: Tracey Scott Hartman Senior Attorney Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792 Deborah Breski 803 Cory Campbell Road Fort Pierce, Florida 34982 Jack McRay, General Counsel Department of Professional Regulation 1940 North Monroe Street Tallahassee, Florida 32399-0792 Judie Ritter, Executive Director Department of Professional Regulation Board of Nursing 111 Coastline Drive, East Room 50 Jacksonville, Florida 32202
