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Title:Methods of Diversion and Effective Controls for Controlled Substances
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Body:Practitioner Diversion Awareness Conference Methods of Diversion Scott Brinks, Staff Coordinator

LEGAL DISCLAIMER The following presentation was accompanied by an oral presentation on March 18-19, 2019, and does not purport to establish legal standards that are not contained in statutes, regulations, or other competent law. Statements contained in this presentation that are not embodied in the law are not binding on DEA. Summaries of statutory and regulatory provisions that are summarized in this presentation do not purport to state the full extent of the statutory and regulatory requirements of the cited statutes and regulations. I have no financial relationships to disclose. 2 U.S. Drug Enforcement Administration Diversion Control Division

This presentation is for educational purposes only. This presentation may not be further copied or used, with the embedded images and videos, without an independent analysis of the application of the Fair Use doctrine. Fair Use Under section 107 of the Copyright Act of 1976, allowance is made for "Fair Use" for purposes such as criticism, comment, news reporting, teaching, scholarship, education and research. Fair Use is a use permitted by the copyright statute that might otherwise be infringing. Any potentially copyrighted material used in this presentation has been reviewed and found to be used in a manner consistent with Fair Use. A completed Fair Use checklist is attached. Fair Use Act Disclaimer 3 U.S. Drug Enforcement Administration Diversion Control Division

Course Objectives . Laws and Regulations - Review the responsibilities and regulations that apply to practitioners. . Practitioner Methods of Diversion - Identify and discuss the schemes used to acquire controlled substances. 4 U.S. Drug Enforcement Administration Diversion Control Division

Course Objectives . Staff Methods of Diversion - Identify and discuss the schemes used to acquire controlled substances. . Patient Methods of Diversion - Identify and discuss the schemes used to acquire controlled substances. . Effective Controls - List safeguards that a practitioner can use to protect his/her medical practice. 5 U.S. Drug Enforcement Administration Diversion Control Division

Questions to Discuss At the completion of this block of instruction you will be able to answer the following questions: 1. Is a pharmacist obligated to fill a prescription that is presented by a patient or demanded to be filled by a practitioner? 2. All applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances? 6 U.S. Drug Enforcement Administration Diversion Control Division

Questions to Discuss 3. What is the best safeguard to identify if a patient is doctor shopping? 4. Who has the potential to divert controlled substances? 5. By using EPCS, a practitioner can minimize the potential of altered/forged prescriptions? 7 U.S. Drug Enforcement Administration Diversion Control Division

Objective #1 Laws and Regulations Related To Practitioners 8 U.S. Drug Enforcement Administration Diversion Control Division

Practitioner . As a practitioner, your role in the proper prescribing, administering, and dispensing of controlled substances is critical to patients' health and to safeguard society against the diversion of controlled substances. . The DEA is committed to working jointly with the medical community to ensure that legitimate controlled substances are not being diverted for illegal use. 9 U.S. Drug Enforcement Administration Diversion Control Division

. All applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances. 21 CFR §1301.71(a). . The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner. 21 CFR §1306.04(a). Regulations Applicable to Practitioners 10 U.S. Drug Enforcement Administration Diversion Control Division

. Prescription for a controlled substance must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice but a corresponding responsibility rests with the pharmacist who fills the prescription. 21 CFR 1306.04(a). Regulations Applicable to Practitioners 11 U.S. Drug Enforcement Administration Diversion Control Division

. Just because a prescription is presented by a patient or demanded to be filled for a patient by a doctor's office or a doctor, a pharmacist is NOT obligated to fill the prescription! Regulations Applicable to Practitioners 12 U.S. Drug Enforcement Administration Diversion Control Division

Laws Applicable to Doctors 1. According to the CSA, a doctor may administer prescribe or dispense a controlled substance if the following exists: a. Legitimate medical purpose b. Done "within the usual course of professional practice" 13 U.S. Drug Enforcement Administration Diversion Control Division

Establishing Doctor/Patient Relationships . Patient has a medical complaint. . Doctor takes medical history. . Physical examination is performed. . Logical connection between the above three and the drug being prescribed. 14 U.S. Drug Enforcement Administration Diversion Control Division

Good Practices . Complete medical history . Medical examinations . Appropriate tests . Diagnosis . Treatment plan . Appropriate follow-up 15 U.S. Drug Enforcement Administration Diversion Control Division

Objective #2 Methods Of Diversion By Practitioners 16 U.S. Drug Enforcement Administration Diversion Control Division

. Money - Financial Gain . Fear . Stop Blackmail . Sexual Favors . Keep Business Going/Co-dependency . Addiction - Supply Family Members . Personal Use - Self Abuse Motivations for Diversion 17 U.S. Drug Enforcement Administration Diversion Control Division

Case Study Background . Doctors office was located in a town of approximately 3000 people in rural Ohio. . Doctors office was in an old gas station. . The undercover was DEA Agent from Parma (over 120 miles away). . Patients would line up down the street to get into see the doctor. 18 U.S. Drug Enforcement Administration Diversion Control Division

Problems With Undercover Visit What did the doctor do wrong? . No medical exam. . Doctor corrected his injury. . No exam room. . Parma - 120 miles away 19 U.S. Drug Enforcement Administration Diversion Control Division

20 .Patient hinted that he used the oxycodone in the past illegally. .Patient directed what controlled substances he wanted. .Patient offered more cash for more drugs. The doctor said next time after he was offered the extra cash. .Patients were walking in and out during the exam. Problems With Undercover Visit U.S. Drug Enforcement Administration Diversion Control Division

This is the patient chart from the undercover office visit that was played earlier. .Progress notes written on "rapid memo." .A lot of the information on this memo was never told to the patient. .This was the complete summary that the doctor would write for the patient visit. .This was almost identical for all patients. Documentation 21 U.S. Drug Enforcement Administration Diversion Control Division

Signs Of Practitioner Diversion Doing one or more of these does not make prescribing illegal. It is the totality of the circumstances. This list is not all inclusive. 1. Does the practitioner follow state laws when prescribing controlled substances? 2. Does the practitioner conduct cursory medical exams or any medical exam at all? 22 U.S. Drug Enforcement Administration Diversion Control Division

3. Does the doctor do diagnostic testing or refer the patient out for diagnostic testing (x-ray, MRI, etc)? 4. Is the practitioner referring patients to other specialists (surgery, physical therapy, etc)? 5. Are the initial office visits or follow-up visits brief? Signs Of Practitioner Diversion 23 U.S. Drug Enforcement Administration Diversion Control Division

6. Does the practitioner prescribe multiple drugs within the same drug category? 7. Does the practitioner prescribe excessive quantities of controlled substances relative to the medical condition the prescription is purported to treat? 8. Do patients travel a great distance to see the practitioner? Signs Of Practitioner Diversion 24 U.S. Drug Enforcement Administration Diversion Control Division

9. Does the practitioner ignore signs of abuse? . Patient appears to be under the influence. . Patient asks for the controlled substances he wants. . Patient is doctor shopping in PMP. . Practitioner is warned by family members that the patient is abusing or selling his controlled substances. . Ignoring toxicology reports. Signs Of Practitioner Diversion 25 U.S. Drug Enforcement Administration Diversion Control Division

10.Does the practitioner start on a low dose or low level controlled substance and then over time work up to higher levels, or does the practitioner just start the patient on a high dose narcotic? 11.Does the practitioner continue to prescribe controlled substances to patients even though it would be ineffective for treatment purposes? Signs Of Practitioner Diversion 26 U.S. Drug Enforcement Administration Diversion Control Division

12.Does the practitioner only treat patients with narcotic controlled substances? 13.Does the practitioner allow the non-medical staff to determine the narcotic to be prescribed, the practitioner just signs the prescription? Signs Of Practitioner Diversion 27 U.S. Drug Enforcement Administration Diversion Control Division

14.Does the practitioner coach patients on what to say so that the patient can get the narcotics they want? 15.Does the practitioner violate his own pain management policies and guidelines? 16.Does the practitioner ignore warnings from insurance companies, law enforcement, other practitioners, family members, etc? Signs Of Practitioner Diversion 28 U.S. Drug Enforcement Administration Diversion Control Division

17.Does the practitioner receive other compensation for narcotic prescriptions (sex, guns, drugs etc)? 18.Does the doctor still charge the patient for a visit if they do not get a narcotic prescription? 19.Patient deaths. 20.Doctors use inventory for personal use. Signs Of Practitioner Diversion 29 U.S. Drug Enforcement Administration Diversion Control Division

Objective #3 Methods of Diversion By Staff/Employees 30 U.S. Drug Enforcement Administration Diversion Control Division

Methods of Diversion (Employee/Staff Involvement) 1. Steals prescriptions or forges doctor prescriptions. 2. Steals and adjusts doctor's inventory. 3. Calls in fake prescriptions. 4. Falsifies verifications when pharmacist calls the doctor's office. 5. Pretends to dispose of drugs. 6. Replaces medication with placebo. 31 U.S. Drug Enforcement Administration Diversion Control Division

Methods of Diversion (Employee/Staff Involvement) 7. Takes advantage of older/busy doctors. 8. Uses the DEA number of a retired doctor. 9. Orders inventory without doctor's knowledge. 10.Sets up break-ins, burglaries or armed robberies. 32 U.S. Drug Enforcement Administration Diversion Control Division

Hydromorphone Drip Bag- Sugar Cubes Source: Hospital Price per cube: $15/cube Drops per cube: 10 33 U.S. Drug Enforcement Administration Diversion Control Division

Objective #4 Methods Of Diversion By Patients 34 U.S. Drug Enforcement Administration Diversion Control Division

Methods of Diversion (Patient Involvement) 1. Patients who want appointments towards the end of office hours or arrives after regular business hours. 2. Patients who demand immediate attention. 3. Patients who are not interested in an examination or undergoing diagnostic tests. 4. Patients who are unwilling to give permission to obtain past medical records. 35 U.S. Drug Enforcement Administration Diversion Control Division

Doctor Shopping PATIENT i.e. Patient visits several doctors to obtain multiple prescriptions *To protect your practice from this problem: use PDMP regularly 36 U.S. Drug Enforcement Administration Diversion Control Division

Possible Signs of Drug Seekers 5. Fictitious Records. 6. Carry own records. 7. Wounds inflicted to self, family members, and pets. 8. Request specific medication due to allergies. 9. Vacationing in area, no local address. 10. Request pain meds for a pet. 37 U.S. Drug Enforcement Administration Diversion Control Division

11.Patient recites textbook symptoms. 12.Patient gives very vague medical history. 13.Patient claims they failed to pack medication, lost it, or that it was stolen. 14.Patient claims that hospital or clinic, with past medical records, is out of business or burned down. Methods of Diversion (Patient Involvement) 38 U.S. Drug Enforcement Administration Diversion Control Division

15.Patient deceives doctors or seeks alternate doctors while normal doctor is out of the office. 16.Patient exaggerates medical condition. 17.Patient solicits Medicaid recipients to use Medicaid cards as payment method. 18.Patient targets a lax doctor. Methods of Diversion (Patient Involvement) 39 U.S. Drug Enforcement Administration Diversion Control Division

19.Patient takes half and sells rest of their medication. 20.Patient offers to buy other patient's pills. 21.Patient looks for employment or volunteers at locations where drugs or prescriptions are exposed. 22.Patient alters prescriptions. Methods of Diversion (Patient Involvement) 40 U.S. Drug Enforcement Administration Diversion Control Division

Objective #5 Effective Controls 41 U.S. Drug Enforcement Administration Diversion Control Division

Effective Controls . Cost effective controls: 1. Follow policies and procedures - don't be lax 2. Don't share passwords 3. Verify destructions 4. Question and report suspicious activities 5. Limit access to drug inventory 6. Train and update staff 42 U.S. Drug Enforcement Administration Diversion Control Division

Effective Controls 7. Be vigilant of staff members 8. Use PDMP regularly 9. Conduct backgrounds of employees (FELONY) 10. Audits - discover discrepancies, losses or thefts in the inventory (2 persons) 11. Keep complete and accurate records 12. Security - store CS in a securely locked, substantially constructed cabinet 21 CFR § 1301.75 43 U.S. Drug Enforcement Administration Diversion Control Division

13. Prescriber personally verifies the prescription orders with pharmacist. 14. Electronic prescriptions (EPCS) - reduces the # of forged/altered/fraudulent scripts. 15. Never sign prescription blanks in advance. 16. Request DEA to terminate your DEA # so that no one can use it illegally. Effective Controls 44 U.S. Drug Enforcement Administration Diversion Control Division

Effective Controls . Contractual agreements: Doctor/Patient . Drug testing at hiring . Random drug testing . Safeguard prescriptions 45 U.S. Drug Enforcement Administration Diversion Control Division

Safeguarding Prescriptions . Keep prescription pads locked in a cabinet when not in use. . Do not leave prescription pads around the office or in your jacket pockets during off hours. . Maintain a record of your prescriptions. 46 U.S. Drug Enforcement Administration Diversion Control Division

Safeguarding Prescriptions . Inspect and number your prescription pads. . Be vigilant of those working near your office. . Write actual amount prescribed (in words). 47 U.S. Drug Enforcement Administration Diversion Control Division

. DEA local office and Tactical Diversion Squad . Local Police, County, State . State Board of Pharmacy, Medicine, Nursing, Dental . Health Department . HHS OIG if Medicare, Medicaid fraud Contacts for Reporting Drug Diversion 48 U.S. Drug Enforcement Administration Diversion Control Division

Course Review . Reviewed the responsibilities and regulations that apply to practitioners. . Identified and discussed the methods used to divert controlled substances. . Listed the safeguards used to protect a practitioner's medical practice. 49 U.S. Drug Enforcement Administration Diversion Control Division

Post Questions 1. A pharmacist is obligated to fill a prescription that is presented by a patient or is demanded to be filled by a practitioner. A. True B. False 50 U.S. Drug Enforcement Administration Diversion Control Division

Post Questions 2. All applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances. A. True B. False 51 U.S. Drug Enforcement Administration Diversion Control Division

Post Questions 3. What is the best safeguard to identify a patient who is doctor shopping? A. Secure prescriptions B. Routinely use the PDMP C. Conduct routine examinations D. Never sign blank prescriptions 52 U.S. Drug Enforcement Administration Diversion Control Division

Post Questions 4. Diversion of controlled substances can be conducted by: A. Staff members B. Practitioners C. Patients D. All of the above 53 U.S. Drug Enforcement Administration Diversion Control Division

Post Questions 5. By using EPCS, a practitioner can minimize the potential of altered/forged prescriptions. A. True B. False 54 U.S. Drug Enforcement Administration Diversion Control Division

Thank-you for your time and attention ! 55