1. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Chapter 4 Comprehensive Drug Abuse and Prevention Control Act: A Closer Look Jahangir Moini, MD, MPH, CPhT

2. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Overview DEA established in 1973 as part of Department of Justice to enforce federal laws regarding use of illegal drugs Drugs or substances with potential for illegal use (and abuse) must be included in controlled substances list

3. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Classification of Scheduled Drugs Drugs under jurisdiction of Controlled Substance Act (CSA) are categorized according to potential for abuse and addictiveness Divided into 5 schedules (Schedule I to Schedule V)

4. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. State vs. Federal Laws When state law conflicts with federal government’s position concerning a specific drug, stricter law takes precedence Discrepancies handled by contacting closest DEA office to determine your state’s regulations and federal government’s

5. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Schedule I Not accepted for medical use in U.S. Extremely high potential for abuse Examples: opiates, opium derivatives (e.g., heroin), crystal methamphetamine, hallucinogens, crack cocaine

6. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Schedule II Have medical uses High abuse potential with severe physical or psychological dependence Examples: opiates and opioids (narcotics, including methadone, morphine, and oxycodone), stimulants, depressants

7. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Have accepted medical uses Less abuse potential than Schedule I and II drugs Examples: anabolic steroids, acetaminophen with codeine, butabarbital, other barbiturates combined with non-controlled drugs such as aspirin Schedule III

8. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Schedule IV Less abuse potential than Schedule III Can still lead to physical or psychological dependency Examples: long-acting barbiturates, certain hypnotics, minor tranquilizers (including benzodiazepines, phenobarbital, diazepam [Valium ® ])

9. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Schedule V Lowest abuse potential Preparations containing limited quantities of certain narcotic drugs, generally antitussive or antidiarrheal Examples: cough syrups containing codeine, pseudoephedrine, analgesics

10. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. DEA Registration for Controlled Substances Individuals who manufacture, dispense, or distribute any controlled substance must register with DEA unless exempted Pharmacy registrations issued for 3 years DEA number must be assigned to registered manufacturers, distributors, wholesalers, and practitioners such as physicians, veterinarians, scientists, pharmacies, and hospitals

11. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Pharmacy Registration All pharmacies must have valid DEA registration New pharmacy applicants required to complete DEA Form 224, and must renew application every 3 years DEA numbers may be checked for accuracy using simple mathematical calculation or online verification Web site

12. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Registration Certificate Falsification of an application will result in suspension or revocation of registration by DEA If applicant has previous felony conviction related to controlled substances suspended registration, or suspended state license, applicant will no longer be allowed to dispense controlled substances

13. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Security of Personnel Background checks should be carried out for all potential employees who will work in proximity of controlled substances Interviewees must supply truthful information about past convictions, criminal charges, and illegal drug use

14. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Regulation of Controlled Substances Specific CSA regulations govern record keeping, physician and pharmacy registrations, and inventory concerning controlled substances

15. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Regulation of Controlled Substances All scheduled drugs used in ambulatory care setting must have complete and accurate records kept concerning purchase, storage, management, and distribution Specific guidelines for controlled substances include: –Most prescription forms must be written in ink or typed

16. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Regulation of Controlled Substances –Individual states may require physical prescriptions –Prescriptions must include date prescribed, patient’s name and address, and physician’s DEA number –Amount prescribed should be written out to avoid using numerals which can cause errors –Physician must physically sign every written controlled substance prescription

17. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Ordering Controlled Substances DEA Form 222 used to order controlled substances from Schedules I or II Has been changed to single-sheet document instead of triplicate form Not used when ordering Schedule III, IV, or V substances

18. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. DEA Form 222 Details Max of 10 different items may be ordered on 1 form, with 1 item per numbered line DEA registrant must notate number of lines completed using a designated space Supplier can only ship to purchaser’s address as listed on Form 222 and DEA certificate

19. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. e222 Electronic version of Form 222 Helps reduce illegal orders of controlled substances Identifiers are used that make it very difficult for non-authorized persons to use

20. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Prescriptions for Controlled Substances Practitioner must issue prescription for a controlled substance for a valid medical purpose Practitioner cannot order drugs for the office using prescription pads—they must use order form or purchase order

21. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Prescriptions for Controlled Substances Prescriptions for Schedule II drugs must be written, not faxed or called in, unless an absolute emergency exists

22. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. E-prescribing Electronic (e-)prescribing is instrumental in reducing medication errors Prescriptions generated electronically through automated data entry and pharmacy-linked transmission network System features warning/alert systems, access to medical histories, streamlined authorizations, and increased patient compliance

23. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Filling Prescriptions for Controlled Substances Prescriptions for Schedule II drugs must be signed in ink, but prescription itself can be created on a computer or handwritten No refills allowed, but partial fillings are allowed if the portion dispensed can be used in a 7-day period Oral prescriptions only allowed in emergencies

24. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Follow-up with a Written Prescription Pharmacist must identify physician, who must follow up with a written prescription within 72 hours Amount dispensed for an emergency should only be that which is necessary until the written prescription can be presented

25. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. File Systems All prescriptions for controlled substances must be maintained in one of the following: –A 3-file system 1 file for Schedule II, 1 for Schedules III–V, and 1 for all other types of prescriptions –A 2-file system 1 file for Schedule II, 1 for Schedules III–V –An alternate file system 1 file for all controlled drugs, 1 for all non- controlled drugs

26. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Labeling of Controlled Substances Federal law and state statutes regulate labeling of controlled substance prescriptions These orders must include: –Pharmacist’s name and address –Pharmacy name –Drug’s serial number

27. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Labeling of Controlled Substances –Date prescription was filled –Prescribing physician’s name –Patient’s name –Directions for use –Any cautionary statements

28. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Container Labeling Containers of controlled substances must designate which schedule applies to contents Schedules labeled as follows: –CIorC-I –CII or C-II –CIIIorC-III –CIV orC-IV –CV orC-V

29. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Exemptions from Labeling Requirements – Schedule II Substances Unit doses dispensed to inpatient hospital, nursing home or other long-term care facility are exempt if: –No more than 7-day supply dispensed –Patient does not possess the drug before he or she can use it –Institution maintains appropriate security

30. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. –Directions for use, cautions, patient, product, and supplier identified by the pharmacist’s record-keeping system –CSA Schedule number included on unit dose Exemptions from Labeling Requirements – Schedule II Substances

31. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Distribution Separate DEA registration needed for manufacturing, distributing, dispensing, and conducting research Pharmacy registered to dispense a controlled substance can distribute (without registering as a distributor) to a physician, hospital, nursing home, or another pharmacy for general dispensing

32. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Distribution Conditions These distributions must meet the following conditions: –Pharmacy or practitioner to which controlled substance is distributed must be listed –If substance is Schedule I or II, transfer must be made using DEA Form 222

33. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. –Distribution is recorded as being distributed by pharmacy, and pharmacist or practitioner records substance as being received –Total number of dosage units of controlled substances distributed does not exceed 5% of total dispensed during 12-month period in which pharmacy is registered Distribution Conditions

34. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. DEA Controls DEA maintains strict controls concerning transfer of controlled substances DEA registrant receiving Schedule I or II drugs must issue a Form 222 to document the drug transfer

35. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Record Keeping Any pharmacy that handles controlled substances must keep complete and accurate records of all drugs received and dispensed Records must be kept for 2 years, though some states require 5 years Schedule II drug records must be kept separately from all other records

36. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Inventory Records CSA requires that, every 2 years, each registrant create a complete, accurate controlled substances stock record After inventorying, an exact count or measure of Schedule II substances must be made An “initial inventory” is a complete inventory made before a new pharmacy opens

37. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Keeping Receipts DEA Form 222 is used as official form of receipt for all Schedule I and II substances Invoices are acceptable to use as receipts for all Schedule III–V substances Each type of receipt must have date item(s) were received

38. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Receipt Information Receipts must contain: –Name and strength of each substance –Dosage forms –Number of dosage units –Container volumes –Number of received containers –Dates of receipt –Supplier’s name, address, and DEA number

39. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Dispersal Record Records of all drugs dispensed from pharmacy and records of all drugs removed from pharmacy for any reason are considered “dispersal records” These include: − DEA Form 222 − Invoices − Record books − Disposal records − Theft or loss record

40. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Returning Controlled Substances When controlled substances from Schedule II are returned, DEA Form 222 must be used These substances may only be returned from one DEA registrant to another Any facility that does not have a DEA number cannot return controlled substances

41. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Dealing with Outdated Controlled Substances When controlled substances become out of date, DEA Form 41 must be used Pharmacist must write a cover letter explaining the situation and requesting DEA permission to destroy these substances Approval for destruction is not required from DEA if destruction is witnessed by Board of Pharmacy investigator

42. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Theft or Loss of Controlled Substances DEA office nearest pharmacy must be notified if controlled substance is lost or stolen DEA Form 106 used, with pharmacy keeping original copy, 2 copies to DEA, and 1 copy to Board of Pharmacy or local police department Significant losses must be reported by phone immediately

43. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Refilling Prescriptions for Controlled Substances Prescriptions for Schedule II controlled substance must not be refilled except in certain limited circumstances

44. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Refilling Prescriptions for Controlled Substances Partial refills of Schedule III–V substances are permissible if each is dispensed and recorded in same manner as refilling, with total quantity not exceeding total quantity prescribed No dispensing can occur after 6 months past date of issue

45. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Recording Refills Pharmacist must enter (on back of prescription) his or her initials, date of refill, and amount of drug dispensed after refilling any Schedule III or V substances Not required if using electronic data retrieval

46. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Computerization of Refilling Pharmacy is allowed to use data processing system for storage and retrieval of prescription refill information for Schedule III and IV controlled substances System must provide immediate retrieval of original prescription information for prescriptions currently authorized for refilling

47. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Facsimile Prescriptions DEA regulations permit prescriptions for Schedule II–V drugs via fax from practitioner directly to pharmacy Pharmacist must review original, signed prescriptions for Schedule II substances in most cases

48. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Facsimile Prescriptions DEA allows fax of written signed prescription to be transmitted to serve as the authority for and record of dispensing of Schedule III–V substances

49. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Storage and Security Requirements Except limited amounts of Schedule I substances being processed must be stored in secure cabinet Schedule II–V substances must be stored as above, though pharmacies can disperse them throughout non-controlled substances stock to obstruct theft or diversion

50. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. Security Measures The following help to ensure strict control and security concerning controlled substances: –Electronic alarm system –Perimeter security –Self-closing and locking doors –System of key control –Controlled accessibility

51. © 2010 Delmar, Cengage Learning. ALL RIGHTS RESERVED. DEA Inspections CSA specifically requires administrative search warrant for most non-consensual DEA inspections DEA agent must state purpose of inspection and present appropriate identification Pharmacy technicians should immediately refer any DEA agents to pharmacist in charge