Controlled Substances-General Overview

1. Controlled Substances-General Overview • Harrison Narcotic Act • Marijuana Tax Act • Narcotics Manufacturing Act of 1960 • Drug Abuse Control Amendments of 1965 • Comprehensive Drug Abuse Prevention & Control Act of 1970 (current law)

2. Harrison Narcotic Act of 1914 • A law for the orderly marketing of opium, morphine, heroin • Small quantities OTC, large quantities Rx • Stated that manufacturers, importers, pharmacists, and physicians prescribing narcotics should be licensed to do so • Made opioids difficult to obtain and users flocked to physicians and hospitals for drugs

3. Marijuana Tax Act of 1937 • Goal was to eradicate marijuana use • Cultivation or transfer of marijuana was legal • Tax = $1 per ounce • Penalty for unauthorized transfer was $100 per ounce

4. 1965 Drug Abuse Control Amendments • Enacted to deal with problems caused by abuse of three dangerous drugs: depressants, stimulants, and hallucinogens. • There was rampant recreational drug use in the 1960’s.

5. Controlled Substances-General Overview • Drugs that are subject to abuse • “Controlled substances” or “scheduled drugs” • Federal Comprehensive Drug Abuse Prevention & Control Act of 1970 (current law) • Also called the “Controlled Substance Act” • Establishes a “closed system” for manufacturing, distributing, and dispensing

6. Controlled Substance Act • Administered by the Drug Enforcement Administration (DEA) • DEA replaced the Bureau of Narcotics and Dangerous Drugs (BNDD) • Medical use of controlled substances regulated primarily by Board of Pharmacy • DEA more concerned with criminal use

7. CSA Addresses • Rehabilitation under community mental health programs • Research in medical treatment of drug abuse & addiction • Import and export of controlled substances • Title II-The Controlled Substances Act administered by DEA/US Dept. of Justice

8. Authority for Scheduling • Given to Federal Gvt by CSA • State Gvt, BofP, can make a drug more restrictive than Federal law (i.e. ephedrine, carisoprodol, pseudoephedrine) • Fed and State Gvt must publish intent to schedule (i.e..., Fed Register, Oregon Bulletin, BOP mailings to licensees)

9. Schedules of Controlled Substances • See 21 CFR 812 and OAR 855-080 • Schedule I-high potential for abuse or no medical use or lack of information on use • Schedule II-high potential for abuse, has medical use, abuse may lead to dependence • Schedule III-less abuse potential than I or II, has medical use, lower potential for dependence

10. Schedules of Controlled Substances • Schedule III may not contain more than certain amounts of narcotics (Abood p 149) • Schedule IV - Low potential for abuse relative to I, II or III., has accepted medical use, abuse may lead to limited problems • Schedule V-Cough medicines, anti-diarrhea preps containing codeine or diphenoxylate

11. Medical Marijuana in Oregon • Must be an Oregon resident to be a registered patient in the Oregon Medical Marijuana Program (OMMP). • Must have a qualifying debilitating medical condition as listed on the Attending Physician's Statement. • Physician must be a Medical Doctor (MD) or Doctor of Osteopathy (DO) licensed to practice medicine in Oregon. • Must have an established patient/physician relationship with your "attending physician." Naturopaths, chiropractors, and nurse practitioners cannot sign the documentation. • OMMP cannot refer you to a physician. The OMMP does not have a physician referral list.

12. Medical Marijuana in Oregon • Must list a grow site address on application. You, or your designated primary caregiver, may grow your own medication. There is no place in the State of Oregon to legally purchase medical marijuana. • The OMMP cannot find a designated primary caregiver for you. The OMMP does not keep a referral list of persons who want to be caregivers for patients. (You are not required to list a caregiver, unless you are less than 18 years old.) Your caregiver cannot be your physician. • The OMMP cannot supply you with seeds or starter plants, or give you advice on how to grow medical marijuana. • The application fee cannot be waived. Partial payments cannot be accepted.

13. Treatment Programs • The term detoxification treatment means the dispensing, for a period of time as specified below, of a narcotic drug or narcotic drugs in decreasing doses to an individual to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of a narcotic drug and as a method of bringing the individual to a narcotic drug-free state within such period of time. • The term maintenance treatment means the dispensing for a period in excess of twenty-one days, of a narcotic drug or narcotic drugs in the treatment of an individual for dependence upon heroin or other morphine-like drug.

14. Controlled Substance Registrant Protection Act of 1984 • Requires a Federal investigation if: • theft of CS > $500 in value • death or injury occurs • Interstate of foreign commerce involved in crime • Increased penalties for robbing a pharmacy

15. Chemical Diversion and Trafficking Act of 1988 • To decrease manufacture of controlled substances • 20 chemicals and tablet/capsule machines placed under Federal control • Manufacturers must verify legitimacy of their customers • Must maintain records of transactions and report to DEA

16. Anabolic Steroids Control Act of 1990 • Lots of abuse of anabolic steroids • Placed into C-III • “Performance enhancing” • Severe health hazards to athletes who use them • Penalties for distribution, possession • The law hasn’t slowed abuse… • See: Barry Bonds, Balco, etc.

17. Comprehensive Methamphetamine Control Act of 1996 • Regulates the OTC sale of ephedrine, pseudoephedrine, and phenylpropanolamine • These are handy “precursor” chemicals for cooking methamphetamine

18. Ephedrine Pseudoephedrine Methamphetamine

19. Registration • Those who manufacture, distribute or dispense a controlled substance must register with DEA and Oregon Board of Pharmacy • Exemption: Employee of registrant, common carrier or employee of wholesaler, patient

20. Registration-Individual Practitioners • Physician (MD/DO), DDS, DVM, NP, ND, PA, pharmacies, not pharmacists • Physicians employed by a hospital that do not have their own DEA number may use the hospital’s DEA number.

21. Activities that Require Registration • Manufacturing, distribution, dispensing, research, instruction, narcotic treatment, chemical analysis, import, export, compounding related to narcotic treatment programs. • Pharmacies may distribute CS to other practitioners (i.e. another pharmacy) without registering as a “distributor”. • Amount of CS may not exceed 5 % of all CS dosage units purchased that same year.

22. Application for Registration • Must register with DEA and Oregon Board of Pharmacy

23. Record Keeping • Conduct physical inventory every year in Oregon-must keep records for 3 yrs. • Perpetual inventory of C-II required in institutional drug outlets (hospitals, LTCF) • Separate inventory required for each drug outlet (i.e., a chain like Fred Meyer) • Inventory date-any time within the time period • Drugs Received-invoices and 222 DEA Order form (C-II) • C-III-V use invoices to document purchases • C-II-Use DEA Form 222-can’t transfer C-II using a Rx from a prescriber

24. 222 Order Forms 1. Prepared by purchaser in triplicate. 2. One item on each numbered line 3. No. of items ordered noted in space provided 4. For each item show: drug name; dosage form (tab…), strength, quantity in container, no. of containers

25. 222 Order Forms 5. Name and address of supplier 6. Signature of Purchaser 7. Date 8. Submit copies 1 and 2 to supplier, file copy #3 in pharmacy

26. 222 Order form • may be obtained and executed only by person whose authorized signature appears on original DEA registration form • If forms are lost, notify DEA and Board. • Power of Attorney. Authorized person can legally delegate authority to sign DEA C-II forms • New for 2005 – online CS ordering!

27. 222 Order Forms-Misc.. a. no corrections allowed b. no cancellations c. no NDC numbers d. fill in all information legibly e. valid for only 60 days

28. 222 Order Forms-Misc.. f. supplier must deliver merchandise to address on order form g. maintain third copy for 3 years h. indicate quantity and date received on 3rd copy i. supplier sends 2nd copy to PDX Office of DEA at end of each month

30. Dispensing Controlled Substances • Drugs Dispensed • Prescription records • Invoices if you sold controlled drugs to another registrant (MD or pharmacy) • DEA 222 order forms if you sold a C-II drug to another registrant • Keep all records for three years

31. Filing Prescriptions Filing Systems - two options • 3 separate files • one for C-II, one for C-III-V, one for non-CS drugs • 2 files • one for C-II, one for all others

32. CS Files: From CFR • Each registered manufacturer, distributor, importer, exporter, narcotic treatment program and compounder for narcotic treatment program shall maintain inventories and records of controlled substances as follows: • (1) Inventories and records of controlled substances listed in Schedules I and II shall be maintained separately from all of the records of the registrant; and

33. CS Rx Files: From CFR • (2) Inventories and records of controlled substances listed in Schedules III, IV, and V shall be maintained either separately from all other records of the registrant or in such form that the information required is readily retrievable from the ordinary business records of the registrant.

34. Hospitals and Institutions • Record of Drug disposition is the Medication Administration Record (MAR) • Daily profile with administration time • indicates medication dispensed, when it was administered, and who administered it

35. Disposal or Destruction of Controlled Substances • Retail and Hospital pharmacies must return outdated, adulterated, misbranded, controlled substances (“Reverse Distributor”)

36. Prescriptions-Definition • An order for medication which is dispensed to or for an ultimate user but does not include an order for medication which is dispensed for immediate administration to the ultimate user. • MAR in a hospital, LTCF is not a Rx • Practitioner can’t write a Rx for Controlled Substances for office use

37. Who Can Prescribe Controlled Substances? • Practitioners who are registered with the State and DEA • MD, DO, DVM, DDS, NP, PA, ND • Office staff can call in a Rx C-III-V. Does not have to be the Doc. • Doc can call in a C-II in emergency only - must have copy of original to pharmacy in 7 days

38. CS Rxs- Requirements • Must be dated when issued - can’t pre or post date • (see BofP Newsletter August 2003 - #348) • All CS Rxs must have: Date written, Date dispensed, Pt name, Pt address, Drug name, Drug strength, Dosage form, Quantity prescribed, Quantity Dispensed (if different), SIG, Prescriber name-address-DEA Number and if C-II the Prescriber signature. • RPh initials if C-III-V, “VOID” if C-II, initials of Person taking Rx over the phone if different than dispenser, initials of person counseling patient-on separate log

39. CS Rx-Purpose of: Found in: 21 CFR 1206.04 1. Legitimate medical purpose 2. By a qualified practitioner 3. Acting in usual course of practice • Rxs for narcotic detox takes a separate DEA registration • Oregon Death with Dignity Act • (We will discuss Oregon Death with Dignity Act later in the quarter!)

40. C-II Rxs-Emergency Definition • Immediate Administration of the drug is needed • No alternative drug will work, including a non C-II drug • Practitioner can’t reasonably get Rx to the patient • Under these conditions, some prescriber’s phone in C-II Rxs for cancer pts, other unusual situations

41. Example of Emergency Dispensing • Patient with terminal cancer runs out of morphine liquid on Friday evening. MD is out of town, but calls pharmacy with a prescription. • Is this an “emergency” dispensing? • When must the pharmacy receive written Rx? • How much would you dispense?

42. Emergency C-II Dispensing • Only in an emergency situation, as defined by the Food and Drug Administration, may a C-II prescription be transmitted verbally by the practitioner, and it must be transmitted directly to the pharmacist. • The practitioner must identify the situation as an emergency, and the pharmacist must document the emergency on the prescription with the phrase, “Authorization for Emergency Dispensing.”

43. Emergency C-II Dispensing • The quantity dispensed is limited to an adequate amount to cover the emergency period. • Within seven days, the prescribing practitioner must provide a written prescription, signed by the practitioner, to the pharmacy to cover this emergency dispensing. File them together.

44. FAXing C-II Prescriptions • A faxed C-II prescription signed by the practitioner is acceptable in LTCF, hospice, or home infusion settings. • Do not need original – FAX serves as original Rx

45. Partial Filling of C-II • You can partially fill a C-II if you are unable to fill the entire Rx (i.e...., don’t have enough medication) • Must fill balance within 72 hours • Can partial fill on patient request, but remaining quantity is voided

46. C-II Rxs Partial Filling You can partially fill C-II Rxs for LTCF, terminally-ill, or hospice patients Must contact prescriber first Prescription is valid for up to 60 days You must record the date, quantity dispensed, quantity remaining, and initials for each dispensing Must note “LTCF” or “terminally-ill” on Rx.

47. Dispensing Limits • C-III-V Drugs are limited to 5 refills or 6 months, whichever occurs first • Rx starts to age the day it is written • No time limits on filling C-II Rxs in CFR • RPh must judge validity/”context” • C-II Rxs can’t be refilled, except as noted • Non-CS Rxs are good for one year

48. Transfer of C-III-V Refills Between Pharmacies Pharmacies with real time-on line systems Can transfer CS Rxs as long as valid refills remain Must transfer all refill information each time Rx must be voided from transferring pharmacy

49. C-II - Changes to Rx • Only after contacting prescriber: • dosage form (tablet/capsule/suspension, etc) • patient address • drug strength • drug quantity • directions for use • See Board of Pharmacy Newsletter 11/2000 (No. 302) … no longer online!

50. RPh Signature on CS Rx • Full signature of filling RPh required on face of C-II Rx • RPh must “cancel” C-II Rx • usually with a diagonal line through face of Rx • Initials on C-III-V (same as non-CS)