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Controlled Substances Laws and Regulations Overview for University of Missouri Hospital

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Title: 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

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

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

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 lt0.5 million per year
  • 1998 1.6 million
  • 2000 gt2 million per year

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

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)

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

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

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

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

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

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

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

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

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)

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

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

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.

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.

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

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

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

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).

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

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

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.

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

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

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.

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/actio
    n by these agencies.

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

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

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.

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

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

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

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

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

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 gt 5 total dosage
    units
  • Office use by practitioner cannot obtain with
    prescription

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

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

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

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

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

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

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

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

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

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

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

51
Prescription Writing
  • CII Prescriptions -- FAX
  • Of original, signed prescription
  • Pharmacy must receive original prescription
    before dispensing
  • Emergency (same as oral emergency)
  • Original not required by pharmacy
  • LTCF
  • Hospice
  • Narcotic injection

52
Prescription Writing
  • CII Prescriptions FAX (continued)
  • Telephone number of originating FAX and date and
    time of transmission, must appear on FAX
  • Pharmacy must file original FAX as prescription
  • Prescriber must maintain the original
    prescription on file.

53
Prescription Writing
  • CII Prescriptions (continued)
  • Computer
  • Pharmacy must receive the original prescription
    before dispensing
  • Emergency (same as oral emergency)
  • Written prescription must be received by the
    pharmacy within 7 days

54
Prescription Writing
  • CII Prescriptions (continued)
  • Quantity
  • Thirty day supply prescribed or dispensed at one
    time
  • Oral/fax/computer emergency quantity for
    emergency period only
  • Medical reason documented
  • Up to a three month supply
  • Prescriber describes medical reason on Rx

55
Prescription Writing
  • CIII-CIV Prescriptions
  • Written
  • Oral
  • FAX
  • Telephone number of originating FAX, date and
    time of transmission on FAX
  • Pharmacy must file original FAX as prescription
  • Prescriber must maintain original prescription on
    file

56
Prescription Writing
  • CIII-CIV Prescriptions (continued)
  • Quantity 90 days supply
  • Refills --No more than 5 times within 6 months
    from Rx date

57
Prescription Writing
  • DEA Proposed PKI process
  • Public key infrastructure (PKI) - Public and
    private IDs
  • Positive ID of sender
  • Guaranteed confidentiality

58
Controlled Substance Activities in Hospitals
  • Facilities should not only have adequate policies
    and procedures in place to prevent diversion of
    controlled substances, they should routinely
    review the practices of their employees to
    guarantee compliance. The pharmacy department is
    responsible for all activities concerning
    controlled substances within that facility.

59
Controlled Substance Activities in Hospitals
  • When violations of controlled substance
    requirements are identified in facilities,
    administrative action may result against the
    facility as well as individual practitioner
    registrants depending upon the situation.

60
21 CFR 1301.91
  • Reporting of drug diversion by fellow employees
    is not only a necessary part of an overall
    employee security program but also serves the
    public interest at large. It is, therefore, the
    position of DEA that an employee who has
    knowledge of drug diversion from his employer by
    a fellow employee has an obligation to report
    such information to a responsible security
    official of the employer.

61
21 CFR 1301.91 (Continued)
  • The employer shall treat such information as
    confidential and shall take all reasonable steps
    to protect the confidentiality of the employee
    furnishing the information. A failure to report
    information of drug diversion will be considered
    in determining the feasibility of continuing to
    allow an employee to work in a drug security
    area. The employer shall inform all employees
    concerning this policy.

62
Security in Hospitals
  • Medications must be stored in locked storage
    areas
  • Key control
  • Limit access to persons authorized to administer
    or dispense
  • Always carried
  • Pharmacy department responsible for new key
    authorization
  • Limit access in automated dispensing system by
    time and area

63
Security
  • Automated dispensing systems
  • Drawers, vending machine interfaced with patient
    profile
  • Advantages generates automatic records, ability
    to monitor usage by reports
  • Disadvantages overconfidence in system, no peer
    review as exists in manual records, sharing of
    security codes

64
Hospital Controlled Substance Record Keeping
Requirements
  • Records must be maintained separately from
    patient record in a readily retrievable manner.
  • Transfer records between locations must be signed
    by two persons

65
Hospital Controlled Substance Record Keeping
Requirements
  • Order versus prescription
  • Order for controlled substance must be issued by
    an individual with authority to prescribe
  • CS order must be also documented in the patient
    record
  • Signature of ordering practitioner for phone or
    verbal orders required per facility policy

66
Hospital Controlled Substance Record Keeping
Requirements
  • Administration records must document date,
    patient, medication, strength, quantity, dosage
    form and name of person administering.
  • Wastage of unused medication must be conducted by
    one professional with authority to have access to
    CS and witnessed by another authorized person.
  • Documentation of wasting and witnessing
    individuals required.
  • Product wasted must be beyond reclamation.

67
Methods to Detect/PreventCS Diversion
  • Comply with record keeping and security
    requirements
  • Physical counts
  • Observe for tampering
  • QA Conduct audits of various receiving,
    transfer and administration records

68
Methods to Detect/PreventCS Diversion
  • Observe for impairment profile
  • Best workers, may work extra shifts
  • More CS administered and/or wasted
  • Emotional/physical problems
  • Prefers high-use CS areas
  • Prefer evening/night shift
  • Sloppy documentation
  • Numerous restroom breaks

69
Hospital Loss Reporting
  • Document all occurences
  • Pharmacy department to investigate
  • DEA and BNDD loss reports
  • Mandatory reporting by professional licensing
    boards and 21 CFR 1301.91
  • Protection for good faith reporting
  • Local law enforcement reporting

70
Summary
  • Prescription Drug Abuse
  • Impairment of Practitioners and Others
  • The Role of the BNDD
  • Protecting Your Practice

71
Where to Get More Information
  • Internet references
  • Bureau of Narcotics and Dangerous Drugs
  • www.dhss.state.mo.us/BNDD
  • Drug Enforcement Administration
  • www.deadiversion.usdoj.gov
  • Professional Registration
  • www.ded.state.mo.us
  • (select Regulatory/Licensing)

72
BNDD Contact Information
  • Bureau of Narcotics and Dangerous Drugs
  • 912 Wildwood, P.O. Box 570
  • Jefferson City, MO 65102-0570
  • Telephone 573-751-6321
  • Facsimile 573-526-2569

73
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