Opioid Monitoring for Pharmacies: A View from the DEA s Perspective

Transcription

1 Opioid Monitoring for Pharmacies: A View from the DEA s Perspective

2 Learning Objectives 1. Recognize opioid prescribing which is outside of normal prescribing patterns 2. Detect various red flags for inappropriate prescribing of controlled substances

3 Controlled Substances Act O The Comprehensive Drug Abuse Prevention and Control Act (1970) is more commonly known as the Controlled Substances Act of 1970 (CSA). Replaced more than 50 pieces of drug control legislation Established a single control system - narcotic and psychotropic drugs Created five controlled substance schedules based on drug properties Established a closed system to track and account for controlled substances (import/manufacture - distribution to end-user). Facilitated the Compliance Program (1971) currently known as the Division of Diversion Control. Division of Diversion Control monitors all aspects of the legitimate manufacture and distribution of controlled substances.

4 Diversion Control Division Mission To prevent, detect, and investigate the diversion of controlled substances from legitimate sources while Ensuring an adequate and uninterrupted supply for legitimate medical and scientific purposes 4

5 Controlled Substance Schedules Schedule I no currently accepted medical use and a high potential for abuse Schedule II high potential for abuse, with use potentially leading to severe psychological or physical dependence Schedule III moderate to low potential for physical and psychological dependence Schedule IV low potential for abuse and low risk of dependence Schedule V lower potential for abuse than Schedule IV

6 What is a registrant? Registrant any person or entity that is given a DEA certificate of registration, which authorizes the person or entity to handle controlled substances in a particular activity (i.e. manufacture, distribute, dispense, prescribe, administer, etc.). Every person or entity that handles controlled substances must be registered with DEA or be exempted by regulation from registration.

7 Termination of registration; transfer of registration; distribution upon discontinuance of business (CFR ) A registration and any modifications of such shall terminate without any action by the Administration if/when a registrant: Dies Ceases legal existence Discontinues business or professional practice must return certificate and unexecuted order forms (DEA Form 222) Surrenders registration via signed written document or executed DEA Form 104 or DEA Form 104c

8 Separate Registrations for Separate Locations (CFR ) A separate registration is required for each principal place of business or professional practice at one general physical location where controlled substances are manufactured, distributed, imported, exported, or dispensed by a person.

9 Obtaining a New Application O ON-LINE submitted via the DEA Diversion website at: (only 225, 363, & 510 applications can be downloaded) DEA Form 224 and 224a CANNOT be downloaded O PAPER FORMS obtained by calling or by writing to: DEA Headquarters Attn: Registration Section/DRR PO Box 2639 Springfield, VA

10 Renewal Notifications Starting January 2017, DEA will no longer send its second renewal notification by mail. Instead, an electronic reminder to renew will be sent to the address associated with the DEA registration. At this time, DEA will otherwise retain its current policy and procedures with respect to renewal and reinstatement of registration. This policy is as follows: If a renewal application is submitted in a timely manner prior to expiration, the registrant may continue operations, authorized by the registration, beyond the expiration date until final action is taken on the application. DEA allows the reinstatement of an expired registration for one calendar month after the expiration date. If the registration is not renewed within that calendar month, an application for a new DEA registration will be required. Regardless of whether a registration is reinstated within the calendar month after expiration, federal law prohibits the handling of controlled substances or List 1 chemicals for any period of time under an expired registration.

11 Practitioner s Responsibilities Practitioner s Responsibilities to know the role in protecting one s DEA registration and business; become familiar with the regulations that guide the accountability of controlled substances; and recognize the various methods of diversion used to illegally obtain controlled substances and understand the reasons people seek prescription drugs.

12 Which Pharmacies are Required to Apply for DEA Registrations? Any person who is required to be registered and who is not so registered, shall make application for registration for one of the following groups of controlled substances activities, which are deemed to be independent of each other. Application for each registration shall be made on the indicated form, and shall be accompanied by the indicated fee. The application fees are not refundable. IMPORTANT: Notify the DEA Office in advance of any actions regarding any pharmacy changes, moving, selling, transfer and/or closing of business.

13 Chain Registrations Pharmacies chains with at least 50 registrations, Distributors with at least 10 registered locations, and DEA laboratories Corporate official submits affidavit; no individual applications All registrations issued with the same expiration date Corporate office maintains copies, sends registrations to proper sites, and provides power of attorney as required. Corporate office submits renewal applications All registrations tied together by chain indicator number

14 Introduction of Registration and Application Process for a Retail Pharmacy Title 21 Code of Federal Regulations Part USC 843. Prohibited Acts C (a) Unlawful acts It shall be unlawful for any person knowingly or intentionally (4)(A) to furnish false or fraudulent material information in, or omit any material information from, any application, report, record, or other document required to be made, kept, or filed under this subchapter or subchapter II of this chapter 14

15 Introduction of Registration and Application Process for a Retail Pharmacy Title 21 Code of Federal Regulations Part 1300 False or fraudulent material information O O O Not filling out the initial application Misleading responses to Liability Questions Misrepresenting: O True Ownership ( Straw Ownership ) O Financial information O Untrue statements state/local licensure, history of handling controlled substances, etc. Omit any material information O O O Silent partners criminal activity Involvement in health care fraud schemes PENALTIES (1) Except as provided in paragraph (2), any person who violates this section shall be sentenced to a term of imprisonment of not more than 4 years, a fine under Title 18, or both 15

16 Retail Pharmacy Requirements State and Local Licenses South Carolina Pharmacy Board permit South Carolina DHEC controlled substance registration Local business license Complete-every license, certificate, etc. you need to be in business Accurate-business records shall not contain false/misleading info Current CMEA Sales Certification (if selling pseudoephedrine/ephedrine products over the counter) Occupancy and Tax Certifications Records and Recordkeeping Reporting Security 16

17 Combat Methamphetamine Epidemic Act of 2005 (CMEA) O If you are going to handle List 1 Chemical Products, typically pseudoephedrine, you must do: training online and self certification after training. O You will also be required to keep a log book of pseudoephedrine sales. O For all relevant information please visit: click on Resources and find CMEA third down on the drop down box 17

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19 Recordkeeping What you receive DEA Forms-222 (blue copy, properly executed) Wholesaler Invoices DEA Forms 222 for C-II and Invoices for C III-V contain substantially the same elements What you have Inventories Initial Biennial Newly Scheduled/Rescheduled What you dispense/distribute Prescriptions (separate CII and CIII-V prescriptions) DEA Forms-222 (brown copy for supplier orders) DEA Forms-41 (destruction) DEA Form -106 (theft/loss) 19

20 Controlled Substance Order Forms (DEA Form 222) Required for purchase of Schedule I and II controlled substances. May be requested by website, telephone, or fax. Registrant s business activity dictates the number of order books that may be requested: 1 = Analytical Lab, Importer, Exporter, Researcher, Teaching Institution 2 = Mid-Level Practitioner, Practitioner 3 = Narcotic Treatment Program 6 = Distributor, Retail Pharmacy, Manufacturer, Hospital/Clinic 16 = Reverse Distributor Each book = seven (7) order forms.

21 Powers of Attorney for DEA Forms-222 O The e-signature on your DEA Application is the only person in the pharmacy authorized to execute a DEA Form-222 O That person may, however, designate an Attorney-InFact via a Power of Attorney Form (POA) to execute DEA Forms-222. Authorization is also revoked in the same manner O An example of a POA letter is found in 21 CFR (c) 21

22 Controlled Substance Ordering System (CSOS) O Electronic ordering system for controlled substances in all schedules, not just schedules I and II. O DEA does not create or supply CSOS enabled software. O CSOS certificate allowing use must be issued by DEA s CSOS Certification Authority (CSOS CA). O CSOS Signing Certificate is digital equivalent of identification information contained on DEA Form 222. Unlike DEA Form 222 that can be signed by anyone with a Power of Attorney, this Certificate can only be used by the person to whom it was issued. O DEA does not charge additional fees for CSOS participation.

23 Why would a pharmacy want to use CSOS? The allowance for electronic ordering of Schedule I & II controlled substances Timely and accurate validation of a CSOS Subscriber's DEA credentials Reduced number of ordering errors No line item limit on a single order Reduced amount of paper in the ordering process Faster transaction times Lower cost per transaction 17

24 Maintaining Records Every record required to be kept by DEA shall be kept for at least two years if the State requires more than two years, you will follow the State s rule. Required records must be kept in a manner that is readily retrievable for inspection by DEA Investigators at the registered location. See Title 21, Code of Federal Regulations (CFR), Section for more information related to the maintenance of records and inventories Pharmacy Manual, Page

25 Recordkeeping INVENTORIES For each controlled substance in finished form the inventory shall include: (A) The name of the substance; (B) Each finished form of the substance (e.g., 10-milligram tablet or 10milligram concentration per fluid ounce or milliliter); (C) The number of units or volume of each finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial); and (D) The number of commercial containers of each such finished form (e.g. four 100-tablet bottles or six 3-milliliter vials). *If the substance is listed in Schedules II, make an exact count or measure of the contents; or **If the substance is listed in Schedule III, IV, or V, make an estimated count or measure of the contents, unless the container holds more than 1,000 tablets or capsules in which case he/she must make an exact count of the contents. 25

26 Recordkeeping INVENTORIES All inventories taken must indicate the date it was taken and whether it was taken at the opening or close of business. Initial inventories are to be taken when the pharmacy commences business. If there are no controlled substances at the pharmacy (which is most likely the case) the initial inventory must indicate this fact. Biennial inventories are new inventories taken within two years of the initial inventory. The biennial inventory may be taken on any date subsequent to the initial or previous biennial inventory as long as it is taken at least within two years of the previous inventory. Inventories for newly controlled substances shall be taken on the effective date a substance is added to any schedule of controlled substances, shall inventory all stocks of the substance on hand. Thereafter, such substance shall be included in each inventory made by the registrant pursuant to paragraph (c) of this section. 26

27 Some Common DEA Record Keeping Violations No date/amount received on DEA 222s, CSOS, or invoices Sharing of CSOS passwords No Power of Attorney for 222s No initial or biennial inventories No separate inventories (Sch 2 vs Sch 3-5) Audit discrepancies Failing to report thefts and losses Interchanging brand and generic names in dispensing records Unlawful manufacturing of controlled substances 27

28 DEA Violation Penalties Failure to follow the Regulations related to Recordkeeping, security of Controlled Substances and Listed Chemicals, and unlawful distribution may result in: O Civil fine of $10,000 up to $25,000 per violation; O Loss of Authority to Handle Controlled Substances; and or O Imprisonment 28

29 Know Your Employees Registrants should not employ an individual who has access to controlled substances if: 1. That person has been convicted of a felony offense related to controlled substances; 2. That person has been denied a DEA registration; 3. That person has had a DEA registration revoked; or 4. That person has surrendered a DEA registration for cause. Code of Federal Regulations (a)

30 Methods of Diversion Practitioners / Pharmacists Illegal distribution Self abuse Trading drugs for sex/money Pharmacy / Other Theft Armed robbery Burglary (Night Break-ins) In Transit Loss (Hijacking) Internet availability The medicine cabinet /obituaries Pain Clinics

31 Methods of Diversion (continued) Employee pilferage Patients Hospitals Drug rings Practitioners offices Doctor-shopping Nursing homes Forged / fraudulent / Retail pharmacies altered prescriptions Manufacturing / distribution facilities

32 Prescription Fraud Create prescriptions Highly organized Use real physician name and DEA Number False contact information Phone number on prescription answered by individual from office Stolen Prescription Pads Used to create fraudulent prescriptions Individuals recruited to walk prescriptions; paid with part of pills picked up

33 Street prices/values O Oxycodone averages $1 per mg O One Rx 180 Oxy 30mg = $5,400 O Hydrocodone ranges $5 - $12 per tablet depending on strength O Alprazolam ranges $2 - $4 per 1mg tablet, $3 - $6 per 2mg tablet O Fentanyl patches average $1 per mcg

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36 Possible "Red Flags" of Diversion on a Prescription must be Resolved before Filling and Dispensing O The following list contains common indicators of diversion by prescriptions that are facially legitimate O Distance of physician from patient or pharmacy s address O Distance of patient from pharmacy or physician s address O Drug, Dosage, or Quantity does not make sense O Diagnosis Code of script (if listed) does not make sense with drug prescribed 36

37 Possible "Red Flags" of Diversion on a Prescription must be Resolved before Filling and Dispensing (continued) O Prescriptions written by physicians that would not ordinarily treat the condition for which a prescription was written. (Examples: an ophthalmologist treating patients for back pain; a gynecologist treating males for pain). O Prescriptions that are not facially legitimate should NEVER be filled (per se fraudulent.) These include prescriptions that: - contain forged physician signatures; - false physician office information; - Prescription paper that is abnormal 37

38 Other Potential "Red Flags" O Factory-like prescribing, O Patients using the multiple patients getting same drug, dosage and quantity O Patients with the same diagnosis codes repeatedly same address getting the same drugs O Patients coming in often for early refills O Patients offering cash in lieu of insurance when they have insurance 38

39 Other Potential "Red Flags" (continued) O Patients arriving together at the pharmacy with scripts from the same doctor O Patients milling around outside the pharmacy O A patient typically sending another person to pick up their prescriptions 39

40 Other Potential "Red Flags" (continued) O Unlike fraudulent prescriptions that should never be filled when identified, prescriptions that were issued by duly authorized practitioners issued for a legitimate medical purpose are presumptively legitimate unless the pharmacist identifies an abnormality (red flag) on the prescription. O The pharmacist has a responsibility to diligently attempt to resolve any red flags before filling. A corresponding responsibility rests upon the pharmacist who fills a prescription not in compliance with DEA regulations (21 CFR Sect ). 40

41 Corresponding Responsibility Purpose of issue of prescription: Title 21 CFR Section (a) refers to the pharmacists corresponding responsibility to ensure the prescription is filled for legitimate medical purpose and in the normal course of the prescribers professional practice. Breaches of the pharmacist s corresponding responsibility may be imputed to the pharmacy owner(s), resulting in action against the pharmacy registration 41

42 Some Resources for Resolving "Red Flags" O Check SCRIPTS O Verify/Discuss prescriptions with physicians O Know your patients/ask questions O Does the prescription make sense based upon the condition, the drug, and the patient? O Inquire, if any distances are involved, why the patient chose your pharmacy? O Get to know the physicians in your area 42

43 Opioid Epidemic Hydrocodone/Acetaminophen Brand Names: Vicodin, Lortab, Lorcet, Norco, Hycet, Xodol Cocktail used by drug abusers: Hydrocodone Carisoprodol (Soma ) Alprazolam (Xanax ) Hydrocodone second only to marijuana as the drug of choice for teens In 2004 U.S. consumed 99% of world s supply of hydrocodone, yet the U.S. makes up only 4.5% of the world s population 43

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45 Opioid Epidemic Who is to blame? How can we help? What is the answer? 45

46 Why DEA Regulates You O Accessibility O Providing health care solutions to those in your communities O Availability O Controlled substances are a scarce good O Authority O Local, State, and Federal Licensure O Accountability O You stand to lose more than money 46

47 Drug Enforcement Administration [Docket No. 15-2] Jones Total Health Care Pharmacy, L.L.C., and SND Health Care, L.L.C.; Decision and Order On April 29, 2015, Administrative Law Judge Gail A. Randall (hereinafter, ALJ) found that "Respondents violated recordkeeping requirements by failing to record whether Jones Pharmacy's biennial inventory was taken at the opening or close of business, and by failing to indicate the number of tablets per opened commercial container, the number of tablets shipped in each commercial container, and the number of commercial containers that [were] on hand." (citing 21 CFR (e)(3)). Most significantly, the ALJ further found that Respondent's (Jones Pharmacy) pharmacists dispensed controlled substance prescriptions in violation of their corresponding responsibility pursuant to which it is a violation of federal law for a pharmacist to knowingly dispense a controlled substance prescription which was not "issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice." 21 CFR (a). The ALJ credited the testimony of the Government's Expert that the prescriptions presented various red flags, i.e., indicia that the prescriptions were not issued for a legitimate medical purpose. These included that: (1) The patients were traveling long distances (and many came from out-of-state) to obtain the prescriptions; (2) that the patients were prescribed cocktails which included narcotics such as oxycodone, benzodiazepines such as Xanax (alprazolam), and muscle relaxants such as Soma (carisoprodol) which were known to be highly abused; (3) that on some occasions, two patients came from the same out-of-state location and presented identical or nearly identical prescriptions; (4) that purported pain patients presented only prescriptions for short-acting but not long-acting narcotics; and (5) that the patients paid for their prescriptions with cash.

48 Drug Enforcement Administration [Docket Nos and 15-7] Superior Pharmacy I and Superior Pharmacy II; Decision and Order This is a consolidated proceeding involving two pharmacies located in Tampa, Florida with common ownership. On October 8, 2014, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration issued an Order to Show Cause to Superior Pharmacy, L.L.C. (hereinafter, Superior II), which proposed the revocation of its DEA Certificate of Registration BS , pursuant to which it is authorized to dispense controlled substances in schedules II through V as a retail pharmacy. The next day, the Deputy Assistant Administrator issued an Order to Show Cause to Superior Pharmacy, L.L.C. (hereinafter, Superior I), which proposed the revocation of its DEA Certificate of Registration BS , pursuant to which it is authorized to dispense controlled substances in schedules II through V as a retail pharmacy. Specifically, with respect to each pharmacy, the Orders alleged that their "pharmacists repeatedly failed to exercise their corresponding responsibility to ensure that controlled substances they dispensed were dispensed pursuant to prescriptions issued for legitimate medical purposes by practitioners acting within the usual course of their professional practice" and that their "pharmacists ignored readily identifiable red flags that the controlled substances prescribed were being diverted and dispensed despite unresolved red flags." 21 CFR (a).

49 Drug Enforcement Administration [Docket Nos and 15-7] Superior Pharmacy I and Superior Pharmacy II; Decision and Order (continued) The Show Cause Orders further alleged that each pharmacy's "pharmacists dispensed controlled substances when they knew or should have known that the prescriptions were not issued in the usual course of professional practice or for a legitimate medical purpose, including circumstances where the pharmacist knew or should have known that the controlled substances were abused and/or diverted by the customer." Each Show Cause Order then listed various red flags which each Respondent's pharmacists allegedly failed to resolve before dispensing prescriptions, including: (1) Multiple individuals presenting prescriptions for the same drugs in the same quantities from the same doctor"; (2) "individuals presenting prescriptions for controlled substances known to be highly abused, such as oxycodone and hydromorphone"; (3) "individuals paying for controlled substances with cash"; and (4) "individuals residing long distances from the pharmacy. Each Show Cause Order then set forth allegations of specific instances in which Respondents' pharmacists dispensed oxycodone 30 mg or hydromorphone 8 mg without resolving various red flags presented by the patients and/or the prescriptions; the Order further alleged that several of these prescriptions were facially invalid because they lacked the patient's address.

50 Drug Enforcement Administration [Docket Nos and 15-7] Superior Pharmacy I and Superior Pharmacy II; Decision and Order (continued) Each Show Cause Order further alleged that Respondents' pharmacists dispensed hydromorphone, notwithstanding that the "dosage amounts, if taken as directed, far exceeded the recommended dosages of hydromorphone that should be taken on a daily basis. The Superior I Order also alleged that its pharmacists dispensed prescriptions, which were written by the same doctor on the same day, for "large and substantially similar quantities of" oxycodone 30 mg, "to two customers... both of whom resided at the same address," in a town "located approximately 449 miles from" the pharmacy. Likewise, the Superior II order alleged that its "pharmacists dispensed large and substantially similar quantities of hydromorphone and oxycodone to two individuals with the same last name who received their prescriptions on the same day from doctors at the same clinic. In addition, the Superior I Order alleged that the pharmacy "failed to create and maintain accurate schedule II order forms in violation of 21 U.S.C. 842(a)(5)," and that "[a]t least two [of its] pharmacists... shared a private key (password) for digitally signing" controlled substances orders, "in violation of 21 CFR (a), (c), and e. The Superior II Order alleged that it had also failed to maintain accurate schedule II order forms and had failed to retain copy three of these forms as required by DEA regulations. 21 CFR (a) & (e); Sec (a); 21 U.S.C. 827(b)). The Order further alleged that the pharmacy failed to create records of the quantity and date received for orders it placed using the Controlled Substances Ordering System (CSOS) and that it "also failed to electronically archive and link these records to the original order."

51 DEA Diversion Home Page 51

52 Diversion Website Resources O Registration O O O O O modifications Reporting (DEA 106, CSOS, etc.) CMEA 21 CFR 21 USC Drug Disposal Information O Federal Register Notices O Questions & Answers O Contacts 52

53 Test your knowledge 1. True or False: DEA registers each pharmacist who dispenses controlled substances 2. Records are required to be maintained for how long? 3. True or False: DEA numbers are transferrable 53

54 Test your knowledge 4. List some of the red flags related to prescriptions 5. Name some resources that can assist you in resolving red flags on questionable prescriptions prior to dispensing 54

55 Contact Information Debra Black, Diversion Group Supervisor tel: fax: