Controlled Substances Laws and Regulations Overview for University of Missouri Hospital

1. Controlled Substances Laws and Regulations Overview for University of Missouri Hospital Presented By: Susan McCann, R.Ph. Administrator Bureau of Narcotics and Dangerous Drugs BNDD

2. Topics to Be Discussed • Prescription Drug Abuse • Impairment of Practitioners and Others • Drug Diversion • The Role of the BNDD • Controlled Substance Statutes and Regulations BNDD

3. Topics to Be Discussed • Prescription Writing and Dispensing • Individual Practitioners – Who can prescribe? • Long Term Care Facilities • Home Health / Hospice • Hospital practice – orders versus prescriptions • Records • Security • Protecting Your Practice BNDD

4. Prescription Drug Abuse • Culture of drug use in our society • 6% of general population abuses substances including those with legitimate need for prescription drugs • 1st time users of prescription drugs for non- medical use 1980s : <0.5 million per year 1998: 1.6 million 2000: >2 million per year BNDD

5. Prescription Drug Abuse In 2002, an estimated 6.2 million people – 2.6% of the population aged 2 and older were currently (in last month) using prescription drugs non-medically (up from 4 million in 1999) Pain relievers – 2.6 million users Sedatives/tranquilizers – 1.3 million users Stimulants – 4 million users NIDA Research Report Series – Prescription Drugs: Abuse and Addiction Trends in prescription drug abuse BNDD

6. Prescription Drug Abuse From The DAWN Report: • 2000 - 243 drug abuse related ED visits per 100,000 population • 2001 – 252 drug abuse related ED visits per 100,000 population (638,484) • 2001 – 14% of all ED visits were related to narcotic analgesic abuse (90,232) BNDD

7. Impaired Practitioners • 10-17% of health care professionals will abuse drugs/alcohol during career Physical/mental stresses Recreational use Knowledgeable about drugs/”immune from harm” • 65-85 % of professional discipline is related to controlled substance/alcohol issues BNDD

8. Practitioner Impairment • Consequences • Harm to patients • Harm to self • Harm to family • Harm to career • Professional discipline • Arrest and criminal prosecution BNDD

9. Diversion • Illegal possession – possession except as authorized by Chapter 195 RSMo • Felony • DEA Diversion Task Force arresting patients and licensed professionals BNDD

10. Diversion • Occurs from all levels of controlled distribution Manufacturers Distributors Pharmacies Hospitals Ambulances Physician offices, etc. BNDD

11. Diversion • Persons responsible Pharmacists Physicians Nurses Pharmacy technicians Family members Office staff Custodians Patients, etc. BNDD

12. Diversion • Methods of diversion • Theft • Opportunistic • Planned access • Break-ins • Robberies BNDD

13. Diversion • Methods of diversion • Theft • Wastage • Substitution • Theft of patient dose • Theft is often accompanied by record falsification BNDD

14. Drug Diversion • Methods of diversion (continued) • Record falsification • Administration records • Wastage records • Distribution records • Inventory records • Receiving records BNDD

15. Controlled Substance Schedules • CI – CV based upon potential for abuse • CI – no accepted medical use • Research is allowed • Analytical laboratories • Dog handlers (law enforcement) BNDD

16. Controlled Substances Schedules Criteria • Potential for abuse • Pharmacological effect • Current scientific knowledge of substance • History of abuse • Scope, duration and significance of abuse • Risk to public health • Potential for psychic or physical dependence • Whether an immediate precursor of a current controlled substance BNDD

17. Controlled Substances Schedules • Non-controlled abusable agents • Carisoprodol • Nalbuphine • Tramadol • Advertising – not allowed for any schedule BNDD

18. The Mission of the BNDD The mission of the BNDD is to ensure and protect the public health and safety by preventing the diversion and misuse of controlled substance, without prohibiting their appropriate and effective use. BNDD

19. Mission of the BNDD (Cont.) This will be accomplished through the regulation of distribution and use of controlled and dangerous substances, enforcement of controlled substance laws and education of health professionals, regulatory and law enforcement agencies and the public. BNDD

20. Laws and Regulations State and federal controlled substances acts • Closed system of registration, record keeping and security • Similarities/differences • Not all subjects covered by both BNDD

21. Laws and Regulations Other state agency controlled substance laws and regulations • Board of Pharmacy • Board of Healing Arts • Board of Nursing • Department of Health and Senior Services • Bureau of Health Facility Regulation -Hospitals • Section for Long Term Care Regulation • Bureau of Home Health/Hospice • Bureau of Emergency Medical Services –Ambulance services BNDD

22. The Role of the BNDD • Registration • Education • Enforcement • Administrative Action BNDD

23. BNDD Registration • No person shall produce, prepare, distribute, dispense or prescribe controlled substances without first obtaining a registration from BNDD. • Registrations issued are valid for three (3) years (locum tenens are valid for one (1) year). • Registration fee is currently $90.00 ($30.00 for locum tenens). BNDD

24. Registration • Registration required • All legitimate controlled substance activities • Agents excepted from registration requirement: pharmacists, nurses, employees are not registered • No registration issued if controlled substance conviction: • Misdemeanor – 2 years • Felony – 7 years BNDD

25. Registration • Registration process • Application, “renewal” notice • Notify BNDD of change of name, address, or ownership • 24,143 BNDD registrants as of November 11, 2003 BNDD

26. BNDD Registrants • The University of Missouri is registered as a hospital, not a pharmacy. The registration application is signed by the administrator. • Individual practitioners must also have BNDD registration to conduct CS activities within the hospital. BNDD

27. Ambulance Service Amb. Surgical Ctr Analytical Lab Correctional Ctr Dentist Drug Distributor Drug Exporter Drug Importer Drug Manufacturer Hospital LTCF E-Kit Narcotic Treatment Optometrist Pharmacy Physician Podiatrist Researcher Veterinarian BNDD Registrants BNDD

28. Education and Enforcement • Drug Diversion Prevention • Record Keeping Requirements • Controlled Substance Loss Reporting • Security Requirements • Primary Practitioner in Clinic Setting • Dispensing Procedures • Prescription/CS Order Writing • Drug Destruction BNDD

29. BNDD Inspections • BNDD has the authority to inspect the record keeping and security of any registrant or applicant for registration. • BNDD cooperates with other authorities in conducting inspections and investigations. • BNDD inspections of hospitals may be conducted jointly with a state licensure or Medicare survey. BNDD

30. Administrative Action Process Scope of Practice issues are not within the authority of the Bureau of Narcotics and Dangerous Drugs. Allegations related to questionable prescribing and dispensing patterns are referred to the appropriate licensing boards. BNDD will take action based on determination/action by these agencies. BNDD

31. Administrative Action Process Investigations generated by: • Findings on routine inspection • Receipt of loss report • Complaint • Referral • Licensing board • Law enforcement • Other government agency BNDD

32. Administrative Action Process • Non-Public discipline • Letter of Concern • Letter of Warning • Letter of Censure • Public discipline • Probation • Revocation / Denial BNDD

33. Administrative Action Process • Criminal referral • Federal civil fines, imprisonment • Refusal to make or keep records is a misdemeanor • Theft, false prescriptions, and false records are felonies. BNDD

34. Practitioner Office Records • General • Authority to review by DHSS, Board of Healing Arts, law enforcement • Readily retrievable • Separate, or • Electronic or mechanical access, or • Visually identifiable • Provide within three (3) working days • Keep two (2) years • Keep on site, except as allowed BNDD

35. Practitioner Office Records • Required information • Drug name • Form • Strength • Quantity per container • Number of containers BNDD

36. Practitioner Office Records • Required information, continued • Date of transaction • Name/address of person dispensed to • Name/initial of person dispensing • Any other type of disposition • Goal – records are reconcilable BNDD

37. Practitioner Office Records • Purchasing records • Invoices • Record of date received • BNDD audit problems • Permission for central records • DEA Official Order Forms • Record quantity and date received • Only person with POA may sign form to order BNDD

38. Practitioner Office Records • Returns to supplier – unusable, expired • Disposal records • DEA authorized – destroy on site, DEA form • Reverse distributor • Hospital pharmacy or patient care areas • Loss reports BNDD

39. Practitioner Office Records • Transfer records • To other physicians, ambulances, etc. • Use Official Order Form (OOF) for CII • No “borrow & loan” without transfer record or OOF • Distributor registration if > 5% total dosage units • Office use by practitioner – cannot obtain with prescription BNDD

40. Security • Physical security • Substantially constructed, securely locked cabinet • Limited access BNDD

41. Security • Waivers to employ required • For a person with any conviction regarding controlled substances, if that person will have any access to controlled substances • For previous revocation/surrender of a controlled substance registration BNDD

42. Security • Reporting losses • Law enforcement • BNDD • Any theft/significant loss • Report “upon discovery” • Loss report form within 7 days • Permission for interim report • Summary, name of thief, police report • Insignificant loss – file with inventory BNDD

43. Security • Reporting losses (continued) • DEA • Call immediately • Form to follow BNDD

44. Prescribing • Purpose of prescription • Issued in good faith, • Issued in the course of professional practice, and • Issued for a legitimate medical reason BNDD

45. Prescribing • Authorized prescribers • Scope of practice • By profession as defined by licensing board / practice acts • No self prescribing (family is legal, but discouraged) • No de-tox/maintenance of narcotic addiction • Exception: office-based treatment programs - buprenorphine • Using hospital DEA # • Temp license, resident, hospital employee • Only hospital patients – no family, employees, friends • Military # BNDD

46. Prescribing • Collaborative practice with nurses (MO) • RNs not LPNs or Pas • BHA/BON regulation • Agreement, scope of practice • May not prescribe controlled substances • Direct contact with physician before calling controlled substance Rx to pharmacy • BNDD regulation • May dispense/administer to patient after contact with physician • May obtain BNDD registration, no DEA # BNDD

47. Prescription Writing • Rx can be filled only by RPh (not nurse or hospital) • Format, components for CS prescription • Dated on day signed • Name and address of patient • Drug name, strength, dosage form • Quantity (preferably written out) • Complete instructions (preferably not “prn” or “as directed”) • Specify refills BNDD

48. Prescription Writing • Format, components (continued) • Written signature • No stamp or computer generated signature • Name and address of prescriber (and preferably telephone number) • DEA # • Ink • Typewritten, computer generated original • Preprinted or photocopied – confirm if questionable BNDD

49. Prescription Writing CII Prescriptions • Always written, except special circumstances • NO refill • Oral (telephone) emergency • Immediate administration is necessary, no other drug is appropriate, cannot reasonable provide written prescription • Reduce to writing for filing • Quantity limited to emergency period BNDD

50. Prescription Writing CII Prescriptions • Emergency prescriptions (continued) • Written follow up prescription must be received by pharmacy within 7 days to provide authorization for emergency dispensing – attach to oral Rx • Pharmacy will notify BNDD and DEA if no written Rx is received BNDD