Chapter 27 Controlled Dangerous Substances

1. Chapter 27 Controlled Dangerous Substances Jeffery D. Evans, Pharm.D, Associate Professor of Pharmacy Practice

2. Objectives • At the end of this presentation the student will be able to: • Apply various aspects of controlled substance law to practice • Understand the interaction between the Federal CSA and the board rules for LA • Know which agents are in which class

3. Chapter 27 • Purpose • Regulate multiple aspects of Controlled Dangerous Substances • Impose penalties for failing to comply with them. • Impact on pharmacy practice • In most areas significant. Nuclear for example is zero.

4. Definitions (2701) • Important ones (I think) • Central Fill Pharmacy • A pharmacy that fills other pharmacies medications • Controlled Dangerous Substance or Controlled Substance • Any substance deemed an CDS by the Federal or State CSA • Dispense or Dispensing • Deals with controlled substances here, but says the same thing. • <note must be labeled for use by the patient or caregiver>

5. Definitions (2701) • Dispenser • Notice that the word ‘pharmacist’ does not appear here • Persons • Not just humans. Any Entity is considered a person • Practitioner • Allowed to ‘prescribe and administer’ CDSs

6. Definitions (2701) • Prescription or Prescription Drug Order • Must be patient specific. • Sales Representatives or Professional Medical Representatives • Employed by a manufacturer to transfer CDSs to other CDS registrants.

7. What is a schedule? (2703) • This section is verbatim from the LA CSA and the US CSA • Defines what makes a substance get scheduled • Defines what schedule a substance will fall into

8. What words mean inside the scheduling (2703) • ‘Stimulant effect’ • Extended wakefulness, Elation, Alleviation of fatigue, irritability, flight of ideas, loquacity • ‘Depressant effect’ • Calming Effect, sedation, mood depression, increase pain threshold, disorientation • ‘Habit-Forming’ • Compulsive use, Chronic brain syndrome, personailty changes, dependence

9. What words mean inside the scheduling (2703) • ‘Hallucinogenic effect’ – Alteration of • Orientation in time or place, motor coordination, ideation (flight of ideas) • ‘Potential for abuse’ • People take a substance in amounts that may be harmful • Diversion of the drug from proper channels • Patients want to take it without medical advice. • Drug contains or is related to a known CDS

10. CDS Licensure (2705) • Every person who any controlled substance • Manufactures • Distributes • Prescribes • Dispenses • Every person who proposes to engage in the any controlled substance • Manufacture • Distribution • Prescribing • Dispensing

11. CDS Licensure (2705) • Who is exempt from registration? • Workmen for the company • Not sales reps* • Contract carriers • Warehouseman • Person who possesses a CDS pursuant to a valid prescription • People located on the site of a licensed entity • researchers

12. CDS Licensure (2705) • Practitioners who must register • Must have another license before the CDS • May have one CDS for their prescribing, but must have individual licenses for each of their sites. • If only one site, only need one license for practitioner and site • Physicians in possession of a medical license and a CDS license may prescribe marijuana for authorized therapeutic reasons.

13. CDS Licensure (2705) • Pharmacies • Must be licensed by the board of pharmacy • CDS license only valid at the address on the license • Different location = Different license • Manufacturers and distributors • Must be credentialed by the appropriate LA licensing body • Outside folks need a CDS if transporting inside the State

14. CDS Licensure (2705) • Researchers • Must have Institutional Review Board Approval for a trial • Reviewed by board to determine if elgible • Drug Reps • Must show proof of employment if carrying and delivering CDSs

15. I would like a license, how do I get one? (2707) • Application to BOP • ONE CDS license per applicant per location • Can not fax in or submit non-complete applications • If not licensed by other board, must submit to a background check • CDS license is good for one year • If you have a temporary license, you get a temporary CDS license

16. I have a CDS license, how do I keep it (2707) • Complete the form and pay the fees • Must be renewed prior to the expiration date. • May not fax • If expiration date is past, the licensee may not act as if they have a CDS license • If expired for 30 days, the license dies

17. You took my license, may I have it back (2707) • If late renewal • Pay late fees + registration • If expired for • < 1year an administrative assistant may renew • 1 – 5 years the board member in charge of CDS may renew • >5 years full board hearing required • If taken due to loss of other license, other license must be reinstated • Application for reinstatement secondary to board punishment, must occur to the full board

18. What if circumstances change? (2707) • CDS license is only good for the person who it was issued to • All changes of location must be provided within 10 days • If you need a new license (printed), you will pay for it • A CDS license is not transferable • New ownership needs a new CDS license

19. Do they have to approve my application? (2709) • Short answer, no • Must be denied ‘for cause’ • Any CDS issues is cause • Even if you surrender and plead not guilty, they still have cause

20. So I messed up, what can happen? (2711) • This is rehash of Chapter 3, thus will cover there • However, full range of punishments may occur including permanent licensure revokement

21. What will the board inspector be looking for when he stops by? (2713) • Type of activity conducted • What CDSs are handled • Quantity of CDS handled • Location of licensee • Type of building and characteristics of building • Type of storage area (vault) • Adequacy of security systems • Who enters the premises (public) • Local police protection • Documentation

22. Stuff not so interesting to us (2715) • This section deals with storage requirements not of a pharmacy. • Interesting to read, but not directed at Pharmacy

23. How do I store controls in a pharmacy? (2717) • Schedule I • Always in a locked, substantial cabinet • Schedules II, III, IV, and V • Store in a securely locked, substantial cabinet • May disperse such substances throughout the stock of non-controlled substances … as to obstruct theft or diversion of the CDS • People with felonies related to CDSs are not allowed near CDSs in a pharmacy

24. What if some stuff is missing? (2717) • Significant loss or theft must be reported within 1 day • How is a significant loss determined significant? • Actual quantity • Agents lost/stolen • Is the loss tied to an individual • A pattern of loss over a time period • Are the drugs candidates for diversion • Local trends and other indicators for diversion DEA Form 106 must be used to report loss

25. What if a central fill pharmacy loses it? (2717) • Rule is • Whoever is contracted with the carrier, is responsible for filing the loss/theft paperwork • Example • JoeBob contracts with JimBob trucking to pick up scripts from LarryBob’s Central fill pharmacy. A truck done went and got hijacked on the way from LarryBob’s to JoeBob’s. Who reports the loss?

26. No, not important (2719) • Deals with freight forwarding facilities • I assume life FedEx or UPS

27. Are there questions you should ask of new employees? (2721) • Yep! Within the past five years, have you been convicted of a felony, or within the past two years, of any misdemeanor or are you presently formally charged with committing a criminal offense? (Do not includeany traffic violations, juvenile offenses or military convictions, except by general court-martial.) If the answer is yes, furnish details of conviction, offense, location, date and sentence. In the past three years, have you ever knowingly used any narcotics, amphetamines or barbiturates, other than those prescribed to you by a physician or other authorized prescriber? If the answer is yes, furnish details.

28. Symbol required on all controlled stock bottles (2723,2725,2727) • If controlled, the commercial bottle must have the schedule symbol on it* Schedule I - CI or C-I Schedule II - CII or C-II Schedule III - CI or C-III Schedule IV - CI or C-IV Schedule V - CI or C-V Must appear large enough to notice when walking by. Bottles must be tamper evident * If bottle too small, it does not need to appear

29. Exporting and importing (2729) • Not really important to pharmacy • Deals with manufacturers

30. What records should I keep for CDSs? (2731) • Practitioners are required to keep records for all CDSs which are dispensed • Not if they are prescribed or administered • They are required if prescribed for detox or maintenance of addiction. • If they charge for administered or dispensed meds, they must document. • Midlevels must keep documentation of what they may prescribe • Records must be kept in English, or a translator must translate within 72 hours if requested.

31. How should I store my CDS records? (2731) • All records should be kept for at least two years • Records can be kept at a central location • If financial or shipping • Executed order form can not be kept at a central location • If you use special equipment, you must provide the investigator with that equipment • Prescriptions and prescription records are special

32. How do I store my prescription records? (2731) • Records • Dealing with CI or CII must be stored in a different place than other records • CIII, CIV, or CV must be stored in a different location than other records • Prescriptions must be stored in one of the three following ways? • A ‘C’ in red ink of at least 1 inch in height stamped in the lower right corner • Have a CII, CIII – CV, and a non-controlled file

33. What about records dealing with central fill pharmacies? (2731) • Pharmacy must have information about each central fill pharmacy (CFP) it uses including • Name • Address • DEA Number • Pharmacy must also document that it verifies the registration of the CFP • The CFP must do the same for the pharmacies it serves

34. Should I complete an inventory? (2733) • Inventories must be in hard copy • If electronic, then print • If oral, then transcribe it • Initial Inventory date • Occurs when the business first handles CDSs • Biennial Inventory • Every one, but PHARMACY, must do an inventory every OTHER year • Pharmacies must do them yearly!

35. Any other times to do a CDS inventory? (2733) • YES! • Change in Pharmacist in Charge • When old one leaves AND • When new one starts. • Substantial Loss of CDS • Theft • Lost • Closure of the Pharmacy (Permanent)

36. What should I count? (2733) • Schedule I or II • Exact counts • Schedule III – V • If container has less than 1k doses in it • Guesstimate • If container has 1k or more doses in it • EXACT COUNT ONLY!

37. What must be recorded? (2733) • All of the following data must be kept in the official, writteninventory • Name of substance • Not specified if Brand or Generic is expected • Finished form of the substance • e.g 10 mg tablets, 4 mg capsule • The number of units in each bottle • 100 count bottle with 30 tablets in it • The number of commercial containers • 3 100 count bottles

38. Continuing Records (2735) • An odd little section • Copies verbatim from Federal CSA • But, most of the material was covered in 2733 • Adds section dealing with Compounders for Narcotic Treatment Programs • Requires few extra requirements • Few pharmacists fall into this regulation • GHB dispensers • Again limited people do this • Adds a requirement that you have proof the prescriber may prescribe GHB

39. Is there anything else I should know about reports? (2737) • Yes, most of this deals with manufacturers • Provides exception to ‘institutional practitioners’ who repackage • Meaning? • Most likely hospitals to allow them to not have to do all the paperwork required

40. How do I know if I have had a significant loss of a CDS? (2737) • Consider these • Actual quantity lost in relation to type of business • The specific agent lost • Can the loss be tied to a specific activity or person • A pattern of losses over a time period • Random patterns? • Results of trying to stem losses • Is the drug likely gonna be diverted • Local trends for diversion

41. What do I do if I decide the loss is significant? (2737) • Notify • New Orleans Field Division Office of the DEA • Board of Pharmacy • WITHIN ONE BUSINESS DAY! • Also submit to the NOFDO DEA • A 106 form • Loss should be reported even if they are recovered.

42. Manufacturing of CDSs (2739) • This section does not apply to pharmacy practice • Strange that the Board of Pharmacy regulates industry • Be careful when compounding not to be classified as a manufacturer (more on that elsewhere!)

43. Distributing CDSs (2741) • Note dispensing is not distributing • So most pharmacies do not need to comply • However, the ‘five percent rule’may change that • If you sale (trade, or give) 5% or more of your annual amount of any CDS. You are a distributor and must register as one

44. I would like to buy some CDSs, how do I make this happen? (2743) • Schedule I or II • Require 222 • Duplicate copies must be retained at least two years • Central fill to retail pharmacy is exempt • Electronic 222 is cool • Unique number assigned by purchaser (9 digits) • First two are year, then X, then six unique characters • 11X928S29

45. What about ordering CIII – CV • Requires recordkeeping • But no specific form • BUT, whatever you order from must include • Name, Address and DEA license of supplier • Name of CDS • Dosage form and strength • Amount • When recieved

46. Who can prescribe controlled substances? (2745) • Duly registered, licensed • Physicians • Dentist • Veterinarian • Physician Assistant (no CII, only per protocol) • Advanced PractReg Nurse (only per protocol) • Optometrist (no C-IIs) • Medical psychologist

47. What can a controlled substance be prescribed for? (2745 B) • A prescription for a controlled substance shall be issued for a legitimate medical purpose ny an individual practitioner acting in the usual course of his professional practice. • The responsibility for the proper prescribing of controlled substances rests upon the prescribing practitioner; however, a corresponding responsibility rests with the pharmacist who dispenses the prescription Emphasis from Dr. J. Evans, not BOP

48. What can a controlled substance be prescribed for? (2745 B) • If it is not for a legitimate medical purpose AND • A pharmacist knowingly fills the medication • Bad things can happen • Can not be written for ‘office supply’ or ‘office use.’

49. What about detoxification programs? • Only FDA approved CIII – CV can be used for outpatientdetox supplied by a pharmacy • Only Suboxone/subutex meets this requirement • Methadone written for detoxcan not be filled by a retail pharmacy

50. What needs to be on a CDS Rx? (2745 C) • Must be dated (for date written) • Full name AND address of patient • Drug name, strength, and dosage form • Quantity of drug prescribed • Directions for use • Name, address, telephone number and DEA number of prescriber • If for suboxone must have suboxone DEA number