(YA- ATLL STATE OF FLORIDA G2 oy DEPARTMENT OF HEALTH eS Pay a . : five, weg DEPARTMENT OF HEALTH, . Petitioner, moe v. CASE NOs. 2001-19255 2001-19260 2001-22144 2002-05931 RX NETWORK OF SOUTH FLORIDA, LLC Respondent. i ADMINISTRATIVE, COMPLAINT COMES Now the Department of Health (Petitioner), by and through undersigned counsel, and files this Administrative Complaint before the Board of Pharmacy (the Board) against RX NETWORK OF SOUTH FLORIDA, LLC, (“Respondent”), and alleges: 1. Respondent is and has been at all times material hereto 4 licensed community pharmacy in the state of Florida, having been issued license number PH 177 18. Respondent’s last known address is 5400 South University Drive Suite #107, Davie, Florida 33328. 2. Respondent is an on-line prescription service which fills and dispenses prescriptions requested via the internet in connection with the website company, USAPrescriptions.com. Gwyneth M. Gordon, («Gordon”); is a licensed pharmacist holding pharmacy permit number PS 27618, and she jg the pharmacy department manager at Rx Network. 3. UsAPrescriptions.com is a website company which promotes the sale and d through use of its delivery of prescription drugs, including some controlled substances, by an own name, for ultimate dispensing by Respondent pharmacy. Inspection of October 2001 Inspection 0) Vu 4. On October 18, 2001, an inspection was conducted of Respondent by AHCA Medical Malpractice Investigator, James McKenna, AHCA Senior Pharmacist Investigator Alan Miller, and AHCA Investigator Shuman Lucas, along with Gregg Jones, Cesar Arias, and Gene Odin of the Florida Department of Health, Bureau of Pharmacy Services. 5. The inspection team observed that Gordon was the only pharmacist working in Rx Network while four pharmacy technicians were busy dispensing medications, in violation of section 465.014, Florida Statutes (2000) and (2001), which restricts the technician/pharmacist ratio to 3:1 or less. Gordon identified Diane Lovins, R.N., as an owner of Rx Network. 6. This inspection team also found the pharmacy was utilizing 2 potentially dangerous pre-packaging procedure where numerous plastic bins were filled with hundreds of unlabeled prescription vials containing several different prescription medications. The bins were labeled but only with the name of the medication and the number of pills in the pre-packaged vials in violation of Section 499.006(3), Florida Statutes (2000) and (2001). 7. The inspection also revealed that a single Kirby Lester brand counting machine was being used to count all capsules and tablets during the pre-packaging procedure, including penicillin. This type of counting machine works using gravity. The technicians pour the pills to be counted into a hopper. The pills drop down and through an electric eye which automatically counts the pills. If the pills processed through the machine contain any residue or dust, this residue is then left in the machine. Most types of Penicillin tablets are uncoated and have residue or dust on the surface of the pills. By using the same counting machine to count penicillin tablets or any other uncoated antibiotic in the same machine used to count all other types of medications dispensed by the pharmacy, medications will become contaminated with this residue. As a result, customers allergic to penicillin, for example, may then receive medications containing residue from penicillin causing potentially life-threatening harm. This method of counting all types of pills in one machine can result in potential contamination or adulteration of the medications in violation of sections 499.005(1)-(2), Florida Statutes (2000) and (2001), which state that it is illegal to repackage, sell, or offer to sell a drug that is adulterated. A drug has been adulterated if it has been “. . . prepared, packed, or held under conditions whereby it could have been contaminated with filth or rendered injurious to health.” See, Section 499,006(2), Florida Statutes (2000) and (2001). 8. In addition, evidence was observed during the inspection that medications were not properly stored, allowing for possible contamination. Hundreds of manufacturers’ bottles of medications were found stacked on the floor all around the various working areas and other office space. Vials, vial tops, and pills were also observed on the floor of the working area in the pharmacy. Such evidence is indicative of additional violations of section 499.006(2), Florida Statutes, supra. 9. The investigators also found that Rx Network and Gordon had received 764 prescriptions on October 5, 2001. Of the prescriptions received that date, 348 had been - submitted by Dr. Eric Dale Rosencrantz, of Pembroke Pines, Florida. Also, Dr. Kenneth Rivera- Kolb, of Davie, Florida, submitted 195 of the prescriptions. Lastly, Dr. William Thompson, of St. Charles, Missouri, had submitted 221 of the prescriptions. None of the individual prescriptions submitted were signed by the prescribing physician as required by law pursuant to sections 893.04(1)(b), Florida Statutes (2000) and (2001), and Rule 64B8-9.012(4), Florida Administrative Code (2000) and (2001), all of which require such prescriptions be submitted in writing and signed by the prescribing physician. 10. Many of these prescriptions were submitted for controlled substances, such as Bontril, Meridia and Phentermine, drugs used to treat obesity that were prescribed based on information provided solely by internet questionnaires, in violation of section 893.02(20), Florida Statutes (2000) and (2001): (20) “Prescription” means and includes an order for drugs or medicinal supplies written, signed, or transmitted by word of mouth, telephone, telegram, or other means of communication by a duly licensed practitioner licensed by the laws of the state to prescribe such drugs or medicinal supplies, issued in good faith and in the course of professional practice, intended _to be filled, compounded, or dispensed _by another person_licensed_by the laws of the state to do so, and meeting the requirements of s. 893.04. The term also includes an order for drugs or medicinal supplies so transmitted or written by a physician, dentist, veterinarian, or other practitioner licensed to practice in a state other than Florida, but only if the pharmacist _called_upon to fill such an order determines, in the exercise of his or her professional judgment, that the order was issued pursuant to a valid patient-physician relationship, that it is_authentic, and that the drugs or medicinal supplies so ordered are considered necessary for the continuation of treatment of a chronic or recurrent illness. {Emphasis supplied]. 11. Section 465.003(14), Florida Statutes (2000) and (2001) provides: “Prescription” includes any order for drugs or medicinal supplies written or transmitted by any means of communication by a duly licensed practitioner authorized by the laws of this state to prescribe such drugs or medicinal supplies and intended to be dispensed by a pharmacist. . The term also includes an order written or transmitted by a practitioner licensed to practice in a jurisdiction other than in this state, but only if the pharmacist called upon to dispense such order determines, in the exercise of his professional judgment, that the order is valid and necessary for the treatment of a chronic or recurrent illness. {Emphasis supplied]. 12. Obesity medications require specific evaluations of the patient, including an “in- person” physical examination. See, Rule 64B8-9.012, Florida Administrative Code (2001). Rule 64B8-9.012 at “Medical Standard of Care,” and entitled “Standards for the Prescription of Obesity Drugs,” states, in part, the following standards for medical doctors prescribing obesity drugs: The prescription of medication for the purpose of enhancing weight loss should only be performed by physicians qualified by training and experience to treat obesity. All licensees are expected to abide by the following guidelines and standards in the utilization of any drug, any synthetic compound, any nutritional supplement, or herbal treatment, for the purpose of providing medically assisted weight loss.... (Emphasis added). (3) An initial evaluation of the patient shall be conducted prior to the prescribing, ordering, dispensing, or administering of any drug, synthetic compound, nutritional supplement or herbal treatment and such evaluation shall include an appropriate physical and complete history; appropmiate tests related to medical treatment for weight loss; and appropriate medical referrals as indicated by the physical, history, and testing: all in accordance with general medical standards of care. (Emphasis added). (4) Prescriptions or orders for any drug, synthetic compound, nutritional supplement or herbal treatment for the purpose of assisting in_weight loss must be in writing and signed by the prescribing physician. Initial prescriptions or orders of this type shall not be called_into_a pharmacy by the physician or by an agent of the physician. Even_if the physician is registered as a dispensing physician, a hard copy of the written prescription must _be maintained in the patient’s medical records for each time such weight loss enhancers are prescribed, ordered, dispensed, or administered. (Emphasis added). (5) At the time of delivering the initial prescription or providing the initial supply of such drugs to a patient, the prescribing physician must_personally_meet_with the patient _and personally obtain an appropriate written informed consent from the patient, Such consent must state that there is a lack of scientific data regarding the potential danger of long term use of combination weight loss treatments, and shall discuss potential benefits versus potential risks of weight loss treatments. The written consent must also clearly state the need for dietary intervention and physical exercise as a part of any weight loss regimen. A copy of the signed informed consent shall be included in the patient’s permanent medical record. (Emphasis added). (6) Each physician who is prescribing, ordering, or providing weight loss enhancers to patients must assure that such patients undergo an in-person re-evaluation within 2 to 4 weeks of receiving a prescription, order, or dosage. The re-evaluation shall include the elements of the initial evaluation and_an assessment of the medical effects of the treatment being provided. Any patient that continues on a_drug, synthetic compound, nutritional supplement or herbal treatment assisted weight loss program shall be re-evaluated at least once every 3 months. (Emphasis added). (7) Each physician who prescribes, orders, dispenses, or administers any drug, synthetic compound, nutritional supplement or herbal treatment for the purpose of assisting a patient in weight loss shall maintain medical records in compliance with Rule 64B8-9.003, F.A.C., and must also reflect compliance with all requirements of this mule. (Emphasis added). (8) Each physician who prescribes, orders, dispenses, or administers weight loss enhancers for the purpose of providing medically assisted weight loss shall provide to each patient a legible copy of the Weight- Loss Consumer Bill of Rights as set forth in Sections 501.0575(1)(a) through (e)3., F.S. The physician shall also conspicuously post said document in those rooms wherein patients are evaluated for weight loss treatment (Emphasis added). 13. The law requires physical examinations of the patient, as well as careful observation of the patient during the course of treatment. It is simply not possible to comply with the law cited above without having personally met the patient and physically examined the patient prior to the patient's receipt of the prescribed obesity medication. Prescribing obesity medications based solely on information received from an internet questionnaire does not meet the requirements of law provided above. 14. Accordingly, Respondent is dispensing obesity medications prescribed without benefit of a valid patient/physician relationship in violation of sections 465.016(1)(i), Florida Statutes (2000) and (2001) for dispensing legend drugs, including controlled substances, other than in the course of the professional practice ofpharmacy. For purposes of 465.016(1)(i), Florida Statutes, (2000) and (2001), it shall be legally presumed that the compounding, dispensing, or distributing of legend drugs in excessive or inappropriate quantities is not in the best interest of the patient and is not in the course of the professional practice of pharmacy. Also, the practice constitutes violations of sections 894.04(1) and 893.02(20), Florida Statutes, for dispensing controlled substances outside the course of the professional practice of pharmacy by failing to determine whether the prescriptions were issued pursuant to a valid patient/physician relationship, and by failing to determine that the drugs so ordered are considered necessary for the continuation of treatment of a chronic or recurrent illness, 15. Bontril is a Schedule II controlled substance under section 893.03(3), Florida Statutes. A substance in Schedule III has a potential for abuse less than the substances contained in Schedules I and II and has a currently accepted medical use in treatment in the United States. Abuse of the substance may lead to moderate or low physical dependence or high psychological dependence. 16, Phentermine is a Schedule IV controlled substance under section 893.03(4), Florida Statutes. A substance in Schedule IV has a low potential for abuse relative to the substances in Schedule II and has a currently accepted medical use in treatment in the United States, and abuse of the substance may lead to limited physical or psychological dependence relative to the substances in Schedule Hl. 17. Pursuant to section 893.02(18), Florida Statutes, “[P]otential for abuse” means that a substance has properties of a central nervous system stimulant or depressant or an hallucinogen that create a substantial likelihood of its being: a. Used in amounts that create a hazard to the user’s health or the safety of the community; . b. Diverted from legal channels and distributed through illegal channels, or c. Taken on the user’s own initiative rather than on the basis of professional medical advice. See, Section 893.02(18)(a-c), Fla.-Stat. (2001). 18. The concept of dispensing and distributing these scheduled drugs by permitting them to be specifically requested by the consumer and “ordered” over the internet is a potentially dangerous method of allowing such medications to be “[t]aken on the user’s own initiative rather than on the basis of professional medical advice.” See, Section 893.02(18)(c), Florida Statutes (2000) and (2001). Dispensing controlled prescription drugs in this manner by Respondent runs contrary to the spirit, intent, and purpose of chapter 893 with regard to protecting the safety of the public. 19. As provided in the 2002 edition of the Physician’s Desk Reference, (“PDR”), physicians who prescribe controlled substances used for purposes of treating obesity, such as Meridia, a Schedule IV controlled substance, are warned about the potential dangers of such medications. Under the caption, “Drug Abuse and Dependence,” with regard to Meridia, the PDR provides in part that “physicians should closely monitor their patients” and “should carefully evaluate them for history of drug abuse, observing them for signs of misuse or abuse, (specifically, drug development of tolerance, incrementation of doses, drug seeking behavior.)”[Emphasis supplied]. 20. Inaddition, the PDR advises physicians that Phentermine and other amphetamine- related obesity controlled substances should be taken for only a few weeks. The physicians’ method of submitting prescriptions to Rx Network is contrary to such advice. The AHCA investigation found that the many of the prescriptions written and dispensed for obesity drugs are written for a three months’ supply per purchase. 21. With regard to Bontril, an obesity drug and a Schedule III controlled substance also dispensed by Respondent, the PDR provides under the caption “Precautions,” that “the least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.” As provided under the heading “Warnings,” the PDR adds in part, “{T]olerance to the anorectic effect usually develops within a few weeks. When this occurs, the recommended dose should not be exceeded in an attempt to increase the effect; rather the drug should be discontinued.”[Emphasis supplied]. 22, As a result of the above described business practices, the Respondent filled hundreds of prescriptions each day transmitted by out-of-state and in-state physicians who prescribed for patients located throughout the country, including patients residing in Florida, when said prescriptions were written and submitted based solely on information received from internet questionnaires. 23. Respondent was aware that the physicians were not complying with requirements pertaining to examining and evaluating patients with regard to treating obesity or weight loss. Accordingly, the physicians were issuing invalid prescriptions for obesity drugs and controlled substances outside the course of professional practice, but Respondent continued to dispense these medications instead of reporting the physicians’ violations, as required. 24. In addition, Section 465.024(1), Florida Statutes (2000) and (2001, titled “Promoting the sale of certain drugs prohibited,” provides that “[I]t is further declared to be in the public interest to limit the means of promoting the sale and use of these drugs. All provisions of this section shall_be liberally construed to carry out these objectives and purposes.” (Emphasis supplied). Section 465.024(2), Florida Statutes (2000) and (2001) provides, “[N]Jo pharmacist, owner, or employee of a retail drug establishment shall use any communication media to promote or advertise the use or sale of any controlled substarice appearing in any schedule in chapter 893.” (Emphasis supplied). Hence, Respondent’s use of internet sites, specifically those connected with USAPrescriptions.com, for promotion and solicitation of various controlled substances which Rx Network used to procure customers to whom the pharmacy dispensed controlled substances constitutes a violation of the law. Hence, Respondent was not operating within the course of the professional practice of pharmacy when dispensing medications pursuant to internet based prescriptions as detailed under the circumstances set forth above. 25. During the investigation of October 18, 2001, the investigators requested copies of prescriptions from Rx Network. Diane Lovins, R.N., of Rx Network, refused to provide the investigators with the requested copies. Instead, she contacted her attorney, Sean Ellsworth, who advised the investigators by phone that a subpoena would be required prior to release of copies of any prescriptions. The investigators advised Ms. Lovins that refusal to comply with the request constituted a violation of Section 465.017(1)(c), Florida Statutes (2001) which provides investigators with the legal authority to inspect a pharmacy for purposes of securing “such other evidence as may be needed for prosecution under this chapter.” 26. However, on or about October 24, 2001, Investigator Miller visited Rx Network again to obtain copies of prescriptions filled by the three physicians listed above as samples for the file. The copies were provided to him at that time. Inspection of December 6, 2001 27. On or about December 6, 2001, a re-inspection was conducted by AHCA Investigator James McKenna at Rx Network where Gordon was working as the pharmacy department manager. However, upon arriving for the inspection, Investigator McKenna found only two pharmacy technicians and an administrator working in the pharmacy in violation of Rule 64B16-27.410, Florida Administrative Code, which requires that a pharmacy technician work only under the direct and immediate personal supervision of a Florida licensed pharmacist. Later, a pharmacist came in to the pharmacy from the lunchroom; fifteen minutes thereafter, a second pharmacist arrived in the pharmacy area. However, no sign was posted that the pharmacists were on a break or out to lunch as required by Rule 64B16-27.400(6)(a), Florida Administrative Code, which requires the sign to be clearly posted unless the pharmacy is closed. 28. During the December 6, 2001 inspection, Investigator McKenna observed an unsupervised pharmacy technician working in a room alone behind a closed door. Investigator McKenna observed the unsupervised pharmacy technician opening manufacturer’s bottles of Phentermine 37.5 mg tablets, a schedule IV controlled substance, and pouring the contents of these bottles into a plastic hopper type of box, which at that time appeared to contain approximately 600 Phentermine tablets. The technician then dispensed the medication into vials labeled only with the name of the medication, strength, type of pill, lot number, expiration date, and manufacturer. The vials of pills were then placed with the unsigned prescriptions in violation of Rule 64B16-27.101, Florida Administrative Code, which prohibits a pharmacy, pharmacy employee, or proprietor from knowingly possessing improperly labeled drugs. 29. The re-inspection on December 6, 2001, also revealed that the pharmacy’s computer indicated that seventeen thousand four hundred and ten (17,410) tablets of Phentermine 30 mg, a schedule IV controlled substance used to treat obesity, had been dispensed during a single day of business by Rx Network — specifically, the tablets were all dispensed on the day before the re-inspection, December 5, 2001. A daily log was found dated September 4, 2001, which summarized the list of approximately 300 prescriptions submitted to Rx Network by one physician, Dr. Kenneth Rivera, also known as Dr. Kenneth Rivera-Kolb, of Davie, Florida. 30. Approximately 39 plastic bins containing hundreds of tablets and pills were observed by Investigator McKenna. These medications were not in the original manufacturer’s bottles. Loose caps and prescription vials were observed on the floor of the pharmacy area. In addition, it was only after the administrator and pharmacist stated that they had discontinued selling or dispensing antibiotic medications following the inspection in April 2001 that the investigator pointed out to the employees the seven bins holding approximately one-hundred manufacturer’s bottles of antibiotics on the pharmacy dispensing shelves. At that point, the employees began to remove the bins of antibiotics and place them in a box which they then labeled “to be destroyed.” The pharmacy’s possession of the antibiotic medications which were being kept on the shelves with active stock indicated that the pharmacy may have continued to violate section 499,006(2), Florida Statutes (2001) by dispensing the penicillin in the same counting machine with the other medications as was observed during the prior inspection of the pharmacy. 31. On or about Jamary 31, 2002, AHCA Investigator Laurie Tepperberg, AHCA Senior Pharmacist Alan Miller, and AHCA Investigator Shuman Lucas conducted a re-inspection of Rx Network 32. The re-inspection revealed repeat deficiencies, primarily that pharmacy technicians were continuing to repackage controlled substances from manufacturer bottles to unlabeled vials in quantities of 30 or 90 tablets. Gordon explained to the investigators that the repackaging is done in this manner due to the volume of prescriptions filled each day. Once the vials are filled with medications, the technicians place the patient specific labels on the pre- packaged vials. The pharmacy purchases Phentermine in bottles of 1,000 tablets and repackages these for future prescriptions in violation of Rule 64B16-27.101, Florida Administrative Code (2001). 33. Also during the inspection, a bin containing vials of unlabeled medications was found on top of a counter. The bin had no designation or label as to the type of medication, the lot number assigned, or the manufacturer’s name. Gordon explained that the medications were placed in the bin on the counter because they had been removed from active stock and were waiting for the reverse distributor to remove the medications. However, there was no indication of expiration dates or any other information on the vials in violation of Rule 64B16-27.101, Florida Administrative Code. The investigators advised Gordon to label the medications immediately. 34. Gordon told the investigators she was aware that the physicians who submitted prescriptions to Rx Network, (including those for controlled substances), were writing these d that prescriptions based on information obtained from intemet questionnaires. Gordon advise she was aware that the questionnaire must be completed before the physician may submit a 13 prescription, and that the internet questionnaire utilized is found on the website identified as USAPrescriptions.com. 35. Gordon explained that physicians receive and review information provided by the customers through the internet questionnaire. She stated that she was unaware of how the physicians obtained the questionnaires, even though she was aware the questionnaires originated on USAPrescriptions.com. Both entities, Rx Network and USAPrescriptions.com share the same telephone number for customer service. Gordon stated that the pharmacy downloads the prescriptions written by the physicians and dispenses the medication. The downloaded prescription is the only version on file for that particular prescription. A daily list of prescriptions filled for the day as submitted by each physician is forwarded to the physician for signature confirming that they have authorized the medication dispensed to the patient. 36. The inspectors and investigators advised Gordon that dispensing controlled substances and other legend drugs where no valid patient/physician relationship exists, as in cases involving prescriptions written based on information provided solely by internet questionnaires and in such volume, is dispensing legend drugs without first being furnished a valid prescription. This practice constitutes a violation of section 893.04(1), Florida Statutes (2001) for dispensing controlled substances outside the course of the professional practice of pharmacy as specified in Section 893.02(20), Florida Statutes, which requires that the pharmacist “shall first determine in the exercise of his or her professional judgment, that the order was issued pursuant to a valid patient/physician relationship, that it is authentic, and that the drugs or medicinal supplies so ordered are considered necessary for the continuation of treatment of a chronic or recurrent illness.” Dispensing such prescriptions also violates section 893.04(1)(b), Florida Statutes (2001), for dispensing controlled substances for prescriptions which are not signed by the prescribing practitioner. Further, such actions constitute a violation of section 465.016(1)(i), Florida Statutes (2000) and (2001), for dispensing or distributing a legend drug, including any controlled substance, other than in the course of the professional practice of pharmacy. Also, based on the volume of prescriptions dispensed daily, it would have been logically impossible for Rx Network and Gordon to remain in compliance with Rules 64B16-27.800(2) or 64B16-27.810, Florida Administrative Code (2000) and (2001), which require the maintenance of patient records and proper consultation with the patient profile records prior to dispensing each prescription. First Complaint: Customer “T.M.” 37. In addition to the inspection violations, two unrelated consumer complaints have been filed with the Agency with regard to the intemet dispensing practice of Rx Network. 38. The first complaint received pertained to a customer from Texas, initials “T.M.” On or about October 23, 2001, “T.M.” was on the internet when an unsolicited email message appeared. “T.M.” opened the email which claimed to be an advertisement for herbal products used for weight loss. 39. Once opened, the email directed “T.M.” to log onto www.USAPrescriptions.com. 40. “TM.” did as directed, then corapleted the questionnaire listed on the web page with regard to name, address, telephone number, height, weight, and body mass index and questions pertaining to medical history. The website allowed “T.M.” to make a selection of medications offered. “T.M” chose to purchase ninety (90) tablets, a three-month supply of Phentermine 30 mg, a controlled substance pursuant to section 893.03(4)(zz), Florida Statutes (2001). 41. “T.M.” was charged $169.00 on a credit card for the drugs ordered. The order confirmation provided by USAPrescriptions.com indicated that there had been no charge for “consultation” fees, shipping charges, or taxes. 42. The order confirmation also stated, “[p]ending approval by the staff physician, your order will be processed and shipped within one business day.” There was no indication as to what pharmacy would be responsible for dispensing the product, so “T.M.” was never afforded a choice with regard to which pharmacy would receive and dispense the prescription in violation of Rule 64B16-28.130, Florida Administrative Code, i.e., for participating in any system that restricts a patient’s choice of pharmacy. 43. “T.M.” was never advised of the identity of the physician that would be prescribing the medication. If the patient does not know the identity of the physician and has never met the physician, the obesity medication prescription submitted for that patient is not written within the course of the professional practice of medicine since no valid physician/patient relationship exists. Accordingly, dispensing the medication with such knowledge constitutes a violation of section 465.023(1)(c), Florida Statutes (2000) and (2001), for violating section 893.04(1), Florida Statutes (2060) anc (201), section $93.04(1)(b), Florida Statutes (2000) and (2001), and section 465.016(1)(i), Florida Statutes (2000) and (2001). 44, “TM.” states that on or about October 23, 2001, the bottle of 90 Phentermine 30mg tablets were delivered and received. The tablets were shipped by Fed Ex Standard Overnight Mail. 45. The label on the bottle of Phentermine purchased by “T.M.” was the initial notification to “T.M.” that the medication was dispensed by Respondent, Rx Network of South Florida, with the address of 5400 South University Drive, #107, Davie, Florida 33328, and 16 telephone number of (800) 314-8501 for consultation and the telephone number (866) 377-3727 for customer service. 46. The dispensing pharmacist’s initials on the label were “GMG,” which are Gordon’s initials, indicating that Gordon was the pharmacist that dispensed the prescription. 47. The prescribing doctor listed on the pill bottle’s label is Dr. Ken Rivera, a Florida licensed physician, also known as Dr. Kenneth Rivera-Kolb. 48. At no time did Dr. Ken Rivera physically examine or perform a diagnosis of “T.M.” prior to authorizing the prescription for a 90 day supply of Phentermine 30mg. Moreover, “T.M.” states that “T.M.” does not know and has never met Dr. Rivera. “T.M” was not aware Dr. Rivera had prescribed the medication prior to receiving the Phentermine 30mg in the mail from Respondent. 49. Dr. Ken Rivera authorized the prescription for Phentermine 30mg for “TM.” based solely upon information provided in an internet questionnaire in violation of Rule 64B8- 9.012, Florida Administrative Code, which provides in part: The prescription of medication for the purpose of enhancing weight loss should only be performed by physicians qualified by training and experience to treat obesity. All licensees are expected to abide by the following guidelines and standards in the utilization of any drug, any synthetic compound, any nutritional supplement, or herbal treatment, for the purpose of providing medically assisted weight loss... (Emphasis added), (3) An initial evaluation of the patient shall be conducted prior to the prescribing, ordering, dispensing, or administering of any drug, synthetic compound, nutritional supplement or herbal treatment and such evaluation shall include_an appropriate physical and complete history: appropriate tests related to medical treatment for weight loss; and appropriate medical referrals as indicated by the physical, history, and testing: all in accordance with general medical standards of care. 17 (Emphasis added). (5) At the time of delivering the initial prescription or providing the initial supply of such drugs to a patient, the prescribing physician must_personally_meet_with the patient _and_personally obtain_an appropriate written informed consent from the patient. (Emphasis added). (6) Each physician who is prescribing, ordering, or providing weight loss enhancers to patients must_assure that such patients undergo an in-person_re-evaluation within 2 to 4 weeks of receiving a prescription, order, or dosage. ... (Emphasis added). 50. In participating in the internet questionnaire based prescription business with USAPrescriptions.com and Respondent, Dr. Ken Rivera violated Florida law, (which he is subject to as a Florida physician), and as detailed above. He prescribed obesity medications, many of which are controlled substances, to persons he has never met, does not know, and, of course, has never examined even once. The law requires a physical examination initially, prior to prescribing any obesity medication, then a follow-up physical examination within two weeks. The law also requires careful observation of all patients being treated with obesity medications. Respondent is dispensing such medications to customers who have never been examined and may never be examined for such treatment. Dr. Ken Rivera submitted hundreds of prescriptions each day to Respondent, with most being written for obesity medications. Such prescriptions are not valid, and Respondent and Gordon dispensed these medications upon receipt. By doing so, Respondent and Gordon made these potentially harmful medications accessible to thousands of customers across the country who had not received the medical care required by law prior to or taking such drugs. 18 51. In addition, “T.M.’s” personal physician in Texas advised that the medication purchased from Respondent was a controlled substance, a Schedule IV drug, and that prescribing it without a valid physical examination by a licensed physician was illegal, and that the incorrect dosage had been prescribed and dispensed to “T.M.” 52. “T.M.” decided to return the product to Rx Network or USAPrescriptions.com for arefund. “T.M.” attempted to contact the pharmacy at the customer service number provided on the USAPrescriptions.com web site given for customer assistance. After receiving no answer despite waiting on “hold,” “T.M.” called the phone number on the label of the prescription vial and was able to speak to a female pharmacist who answered, “Rx Network.” The pharmacist advised “T.M.” to call customer service to receive the assistance she needed. “T.M.” advised the pharmacist that no one answered the phone at that number. “T.M.” explained the circumstances and requested a refund for the illegally dispensed prescription she had purchased from USAPrescriptions.com. The pharmacist said she could not assist with obtaining or issuing a refund for the customer. “T.M.” then told the pharmacist that the pharmacy was not licensed to dispense medications to customers in Texas. The pharmacist replied, “I thought it was pending.” “T.M.” then asked the pharmacist why the pharmacy and pharmacists are dispensing medications without first being licensed to do so. The pharmacist simply advised “T.M.” to contact customer service. “T.M.” was never able to receive assistance or a refund from Gordon, Rx Network, or the customer service phone number advertised by USAPrescriptions.com and referred to her by Rx Network’s pharmacist. Second Complaint: Consumer “J.W.” 53. Onor about March 4, 2002, a complaint was received from customer “J.W.” having been forwarded to the Agency from the State of Florida’s Office of Attorney General. “J.W.” was 19 concerned after having received an unsolicited e-mail from USAPrescriptions.com while searching on the internet for recipes. 54. “J.W.” opened the unsolicited e-mail and discovered an advertisement for ordering prescription drugs, including controlled substances, over the internet. The website was listed as USAPrescriptions.com and DiscreetDrugs.com. The telephone number provided by the company on the web site is 1-866-377-3727, the same phone number for customer service that “T.M.” was advised to use after having purchased a controlled substance from Rx Network. 55. The advertisement on the website provides, in part, as follows: “USAPrescription.com is your convenient, safe and private source for FDA approved prescription medications. Upon approval, one of our board-certified US physicians will issue a prescription ‘for an FDA approved medication. Your prescription will be filled and shipped in one business day by a US licensed pharmacy in a discreet package that assures your confidentiality and privacy. We ship to all 50 states. No prior prescription required. Free online consultation. Superior customer service. Our customer care associates are responsive and courteous. We have several contact options.” 56. The website advertises the following weight loss drugs for sale: Phentermine, Didrex, Tenuate, Meridia, Xenical, Bontril, Ionamin, Adipex. 57. The website also offers Vioxx, Celebrex, and Ultram for pain relief. The site also advertises Valtrex, Acyclovir, Viagra, and Ortho Tri-Cyclen, among other prescription medications for sale without prior prescription. 58. The hostmaster for the website and the registrant for the site is listed as USA Prescription, Inc., with the address of 5400 South University Drive, Suite #401, Davie, Florida 33328. Accordingly, the offices for the company that owns the website promoting the sale of controlled substances and other prescription medications to be purchased from Respondent is located in the very same building as Respondent pharmacy. 20 59. USA Prescriptions, Inc. does not hold a pharmacy permit in the State of Florida, yet it advertises and promotes the sale of prescription medications, including controlled substances to millions of consumers seeking such potentially dangerous drugs. In addition, the promotion and advertising of controlled substances is a violation of section 465.024(2), Florida Statutes (2001). 60. On May 15, 2002, pursuant to a request for supplemental investigation, AHCA Investigator Tony Spina logged on to the website USAPrescriptions.com. Investigator Spina found that USAPrescriptions.com is continuing to promote and advertise legend drugs for sale, including obesity drugs, such as Meridia, Xenical, Bontril, Ionamin, Adipex, Phentermine, and Didrex. The site continues to’ utilize internet questionnaires to electronically forward customer requests to a physician, in the same manner as detailed above. 61. On May 15, 2002, Investigator Spina phoned the customer service phone number provided on the website for USAPrescriptions.com, 1-800-377-3727. Upon connection with USAPrescriptions.com, Investigator Spina requested to speak with the pharmacy and was forwarded to Respondent. As of this date, Respondent and USAPrescriptions.com share the same phone number provided for contacting customer service. 62. Accordingly, as of the date of this writing, www.USAPrescriptions.com continues to advertise, promote, and market controlled substances, including obesity drugs, over the internet in the manner detailed above. Moreover, Respondent and Gordon continue to work in association with the internet website, www.USAPrescriptions.com. Respondent and Gordon are currently dispensing obesity medications, controlled substances and other prescription medications, (legend drugs), without benefit of valid prescriptions in violation of sections 456.072(1)(a) and (m), Florida Statutes (2001), for making misleading representations in or related to the practice of the licensee’s profession and employing a trick or scheme in or related to the practice of a profession. 63. As aresult of practicing pharmacy in this illegal manner, Respondent and Gordon continue to be in violation of section 456.072(1)(j), Florida Statutes (2001), for aiding, assisting, procuring, employing, or advising any unlicensed person or entity to practice a profession contrary to this chapter, the chapter regulating the profession, or the rules of the department or the board, and section 465.024(2), Florida Statutes (2001), for using any communication media in conjunction with business associates USAPrescriptions.com and USA Prescriptions, Inc., to promote or advertise the use or sale of any controlled substance appearing in any schedule in chapter 893, Florida Statutes. 64. Further, on its website, USAPrescriptions.com solicits other websites to sign up with and become an affiliate of the company. According to the posted solicitation, once the website becomes an affiliate of USAPrescriptions.com, it receives payments by commission based on the amount of prescription drugs sold by Respondent through that particular website connection. Hence, the central website, USAPrescriptions.com, which procures prescription drug sales for Respondent and Gordon, also advertises for, has made, and continues to make contracts with other companies to share in the proceeds of the monies and profits made from the prescriptions sold over the internet and dispensed by Respondent and Gordon. Since the internet customers are directed to remit payment to the internet website, not to Respondent, the pharmacy and Gordon must receive payment, directly or indirectly, by and through USAPrescriptions.com or USA Prescriptions, Inc., and not directly from the prescription drug recipients, such as “TM”, 22 65. As aresult of participating in the dispensing of prescriptions based on the internet questionnaires in association with USAPrescripitons.com and the affiliated companies connected thereto, Respondent and Gordon are in violation of section 465.035(1)(a), Florida Statutes (2001), for failure of the pharmacy to comply with laws and administrative rules relating to pharmacies and pharmacists during the course of dispensing medicinal drugs pursuant to receipt of electronically transmitted prescriptions, and section 465.185, Florida Statutes (2001), for paying or receiving any commission, bonus, kickback, or rebate or engaging in any split-fee arrangement in any form whatsoever with any physician, surgeon, organization, agency, or person, either directly or indirectly, for patients referred to a pharmacy registered under this chapter, among other violations set forth herein. COUNT ONE 66. Based on the foregoing Findings of Fact, the license of Respondent is subject to discipline pursuant to section 465.023(1)(c), Florida Statutes (2000) and (2001) for violating chapter 465, Florida Statutes, any of the rules of the Board of Pharmacy, chapter 499, Florida Statutes, 21 U.S.C. ss, 821 et seq., known as the Comprehensive Drug Abuse Prevention and Control Act, or chapter 895, to wil: a. Section 893.04(1), Florida Statutes (2000) and (2001) for dispensing controlled substances outside the course of the professional practice of pharmacy as specified in Section 893.02(20), Florida Statutes, which requires that the pharmacist shall first determine in the exercise of his or her professional judgment, that the order was issued pursuant to a valid patient/physician relationship, that it is authentic, and that the drugs or medicinal supplies so ordered are considered necessary for the 23 continuation of treatment_of_a chronic or recurrent illness [emphasis supplied]; and b. Section 893.04(1)(b), Florida Statutes (2000) and (2001), for dispensing controlled substances for prescriptions which are not signed by the prescribing practitioner. COUNT TWO 67. Petitioner realleges each and every factual allegation contained in paragraphs one (1) through sixty-five (65) of the Administrative Complaint. 68. Based on the foregoing, the license of Respondent is subject to discipline pursuant to violation of section 465.023(1)(c), Florida Statutes (2000) and (2001) for violation of chapter 465, Florida Statutes, any of the rules of the Board of Pharmacy, chapter 499, Florida Statutes, 21 U.S.C. ss. 821 et seq., known as the Comprehensive Drug Abuse Prevention and Control Act, or chapter 893, to wit: Section 465.016(1)(i), Florida Statutes (2000) and (2001), for dispensing or distributing a legend drug, including any controlled substance, other than in the course of the professional practice of pharmacy. For purposes of this paragraph, it shall be legally presumed that the compounding, dispensing, or distributing of legend drugs in excessive or inappropriate quantities is not in the best interest of the patient and is not in the course of the professional practice of pharmacy. COUNT THREE 69. Petitioner realleges each and every factual allegation contained in paragraphs one (1) through sixty-five (65) of the Adminsitrative Complaint. 70. Based on the foregoing, Respondent’s license to practice pharmacy is subject to discipline for violation of Section 465.023(1)(c), Florida Statutes (2000) and (2001), for violating chapter 465, Florida Statutes, any of the rules of the Board of Pharmacy, chapter 499, Florida Statutes, 21 U.S.C. ss. 821 et seq., known as the Comprehensive Drug Abuse Prevention and Control Act, or chapter 893, to wit: Section 465.024(2), Florida Statutes (2000) and (2001), for using any communication media in conjunction with business associates ‘USAPrescriptions.com and USA Prescriptions, Inc., to promote or advertise the use or sale of any controlled substance appearing in any schedule in chapter 893, Florida Statutes. COUNT FOUR 71. Petitioner realleges each and every factual allegation contained in paragraphs one (1) through sixty-five (65) of the Administrative Complaint. 72. Based on the foregoing, Respondent’s license to practice pharmacy is subject to discipline for violation of Section 465.023(1)(c), Florida Statutes (2000) and (2001), for violating chapter 465, Florida Statutes, any of the rules of the Board of Pharmacy, chapter 499, Florida Statutes, 21 U.S.C. ss. 821 et seq., known as the Comprehensive Drug Abuse Prevention and Control Act, or chapter 893, to wit: Section 465.035(1)(a), Florida Statutes (2000) and (2001), for failure of the pharmacy to comply with laws and administrative rules relating to pharmacies and pharmacists during the course of dispensing medicinal drugs pursuant to receipt of electronically transmitted prescriptions. COUNT FIVE 73. Petitioner realleges each and every factual allegation contained in paragraphs one (1) through sixty-five (65) of the AdminIstrative Complaint. 74. Based on the foregoing, Respondent’s license to practice pharmacy is subject to discipline for violation of Section 465.023(1)(c), Florida Statutes (2000) and (2001), for violating chapter 465, Florida Statutes, any of the rules of the Board of Pharmacy, chapter 499, 25 Florida Statutes, 21 U.S.C. ss. 82] et seq., known as the Comprehensive Drug Abuse Prevention and Control Act, or chapter 893, to wit: Section 465.185, Florida Statutes (2000) and (2001), for paying or receiving any commission, bonus, kickback, or rebate or engaging in any split-fee arrangement in any form whatsoever with any physician, surgeon, organization, agency, or person, either directly or indirectly, for patients referred to a pharmacy registered under this chapter. COUNT SIX 75. Petitioner realleges each and every factual allegation contained in paragraphs one (1) through sixty-five (65) of the Administrative Complaint. 76. Based on the foregoing, Respondent’s license to practice pharmacy is subject to discipline for violation of Section 456.072(1)(i), Florida Statutes, (2000) and (2001) for failure to report to the Department of Health any person who the licensee knows is in violation of this chapter, the chapter regulating the alleged violator, or the rules of the department or the board. COUNT SEVEN 77. Petitioner realleges the facts contained in paragraphs one (1) through sixty-five (65) of the Administrative Complaint as if fully set forth herein. 78. Based on the foregoing, Respondent’s license is to practice pharmacy is subject to discipline for violating Sections 456.072(1)(a) and (m), Florida Statutes (2000) and (2001), for making misleading representations in or related to the practice of the licensee’s profession and employing a trick or scheme in or related to the practice of a profession. COUNT EIGHT 79. Petitioner realleges the facts contained in paragraphs one (1) through sixty-five (65) of the Administrative Complaint as if fully set forth herein. 26 80. Based on the foregoing, Respondent’s license is to practice pharmacy is subject to discipline for violating Sections 465.016(1)(n), Florida Statutes (2000) and (2001), for violating a rule of the board or department or violating an order of the board or department previously entered in a disciplinary hearing, to wit: Rule 64B16-28.130, Florida Administrative Code (2000) and (2001), for knowingly participating in any system that restricts the patient’s choice of pharmacy; for providing any form of remuneration to the prescriber for any prescription referred to the dispensing pharmacy; for failure to take such measures necessary to ensure the validity of all prescriptions received via electronic transmission; and failure to comply with the requirement that a prescription may be transmitted electronically only with the approval of the patient or the patient’s agent. COUNT NINE 81. Petitioner realleges each and every factual allegation contained in paragraphs one (1) through sixty-five (65) of the Administrative Complaint. 82. Based on the foregoing, Respondent’s license to practice pharmacy is subject to discipline for violation of Section 456.072(1)(j), Florida Statutes (2000) and (2001), for aiding, assisting, procuring, employing, or advising any unlicensed person or entity to practice a profession contrary to this chapter, the chapter regulating the profession, or the rules of the department or the board. COUNT TEN 83. Petitioner realleges each and every factual allegation contained in paragraphs one (1) through sixty-five (65) of the Administrative Complaint. 84. Based on the foregoing, Respondent’s license to practice pharmacy is subject to discipline for violation of Section 465.023(1)(c), Florida Statutes (2000) and (2001), for violating chapter 465, Florida Statutes (2000) and (2001), to wit: Section 465.014, Florida Statutes (2000) and (2001), which provide in part that “a licensed pharmacist may delegate to nonlicensed pharmacy technicians those duties, tasks, and functions which do not fall within the purview of s,465.003(13). All such delegated acts shall be performed under the direct supervision of a licensed pharmacist who shall be responsible for all such acts performed by persons under his or her supervision . . . .No licensed pharmacist shall supervise more than one pharmacy technician unless otherwise permitted by the guidelines adopted by the board. The board shall establish guidelines to be followed by licensees or permittees in determining the circumstances under which a licensed pharmacist may supervise more than one but not more than three pharmacy technicians.” COUNT ELEVEN 85. Petitioner realleges each and every factual allegation contained in paragraphs one (1) through sixty-five (65) of the Administrative Complaint. 86. Based on the foregoing, Respondent’s license to practice pharmacy is subject to discipline for violation of Section 465.023(1)(c), Florida Statutes (2000) and (2001), for violating chapter 465, Florida Statutes, any of the rules of the Board of Pharmacy, chapter 499, Florida Statutes, to wit: Sections 499.005(1-2) and 499.006(3), Florida Statutes (2000) and (2001), for offering for sale adulterated drugs and for preparing and packaging drugs for sale in a manner that allows for contamination and adulteration. COUNT TWELVE 87, Petitioner realleges each and every factual allegation contained in paragraphs one (1) through sixty-five (65) of the Administrative Complaint. 88. Based on the foregoing, Respondent’s license to practice pharmacy is subject to discipline for violation of Section 465.023(1)(c), Florida Statutes (2000) and (2001), and Sections 28 465.016(1)(n), Florida Statutes (2000) and (2001), for violating a rule of the board or department or violating an order of the board or department previously entered in a disciplinary hearing to wit: a. Rules 64B16-27.400, 64B16-27.410, 64B16-27.420, and 64B16-27.430, Florida Administrative Code (2000) and (2001), for failure to properly supervise pharmacy technicians and failure to comply with specific requirements pertaining to employment of pharmacy technicians; and b. Rule 64B16-27.400(6)(a), Florida Administrative Code, for failure to post a sign providing notice that the pharmacist(s) are on meal break unless the pharmacy is closed; and & Rule 64B16-27.101, Florida Administrative Code (2000) and (2001), which prohibits a pharmacy, ‘pharmacy employee, or proprietor from knowingly possessing improperly labeled drugs; and d. Rules 64B16-27.800(2) and 64B16-27.810, Florida Administrative Code (2000) and (2001), for failure to comply with the minimum requirements for maintaining patient records, and for failure to properly consult with the requisite patient profile records prior to dispensing the internet prescriptions. COUNT THIRTEEN 89. Petitioner realleges each and every factual allegation contained in paragraphs one (1) through sixty-five (65) of the Administrative Complaint. 90. Based on the foregoing, Respondent's license to practice pharmacy is subject to discipline for violation of Section 465.023(1)(c), Florida Statutes (2000) and 29 (2001), and Sections 465.016(1)(n). of the board or department or violating an order of the board or cepagument previou: o- uy Vit i Mort, entered ina disciplinary hearing to wit: ¢ 64B16-27.104(2), Florida Administrative Code (2000) a Ru Florida Statutes (2000) and (20643, fop violating a'nile O25 py a) oe 4S and (2001) for maintaining a location other than a lawfully licensed pharmacy from which to solicit medication. WHEREFORE, Petitioner ‘respectfully requests the Board of Pharmacy to enter an order imposing one or more of the following penalties: revocation or suspension of the Respondent's pharmacy pemmit, restriction of! administrative fine and assessm the Respondent’s pharmacy operation, imposition of an ent of costs associated with attomey time, issuance of a reprimand, placement of the Respondent on probation, and/or any other relief that the Board deems appropniate. SIGNED this _ / Yh, day of , 2002. i COUNSEL FOR PETITIONER: j Pi LeeAnn Knowles, Senior Attomey 7 Florida Bar #0699535 Agency for Health Care Administration P. O. Box 14229 Tallahassee, Florida 32317-4229 LK/tu PCP: June 10, 2002 PCP Members: Poston/Motley John O. Agwunobi, M.D., M.B.A., Sey tary y M. Snurkowski Chief Attomey—Practitioner Regulation FILED DEPARTMENT OF HEALTH DEPUTY CLERK CLERK Veh h, Keren pare & [18_ [2% 30

Docket for Case No: 02-002977

Orders for Case No: 02-002977