CONTROLLED SUBSTANCES LAWS AND REGULATIONS

1
CONTROLLED SUBSTANCES LAWS AND REGULATIONS

• Presented by
• Susan McCann, R.Ph.
• Administrator, BNDD

2
Topics to be Discussed

• Controlled Substance Law
• Drug Abuse / Impairment
• Drug Diversion
• Department of Health and Senior Services The
  Role of the BNDD
• Laws and Regulations
• Registration

3
Topics to be Discussed (continued)

• Prescription Writing and Dispensing
• Individual Practitioners Who can prescribe?
• Long Term Care Facilities
• Home Health / Hospice
• Hospital practice orders versus prescriptions
• Records
• Security

4
Prescription Drug Abuse

• Culture of drug use in our society
• 5-6 of population abuses substances
• 1st time users of prescription drugs for non-
  medical use
• 1980s 0.5 million per year
• 1998 1.6 million
• 2000 gt2 million

5
National Household Survey on Drug Abuse

• Conducted by Substance Abuse and Mental Health
  Services Administration (SAMHSA)
• 15.9 million people were current illicit drug
  users representing 7.1 of the population 12
  years or older (up from 6.3 in 2000 and 4 in
  1999)
• This figure rose to 19.5 million people in 2002
  (8.3) and 2003 (8.2).

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Drug Abuse/Impairment

• 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

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Drug Abuse/Impairment (continued)

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

8
Drug Diversion

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

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Drug Diversion (continued)

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

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Drug Diversion (continued)

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

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Drug Diversion (continued)

• Methods of diversion (continued)
• Record falsification
• Forged, altered prescription
• Administration records
• Distribution records
• Inventory records
• Receiving records
• Physician orders, etc.

12
Department of Health and Senior Services BNDD

• Organization/staffing
• Registrations
• Inspections/investigations
• Administrative actions
• Education

13
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

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Laws and Regulations (cont.)

• Other state agency controlled substance laws and
  regulations
• Boards of professional licensure
• Pharmacy, Healing Arts, Dentistry, Podiatry,
  Optometry, Veterinary Medicine
• Department of Health and Senior Services
• Health Facilities Regulation Unit-Hospitals
• Section for Long Term Care - LTCF
• Home Health/Hospice Unit
• Emergency Medical Services Unit Ambulance
  services

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References for Laws and Regulations

• DHSS www.dhss.mo.gov/BNDD
• Board of Pharmacy
• http//pr.mo.gov/regulated-professions.asp
• Drug Enforcement Administration
• www.deadiversion.usdoj.gov

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Schedules of Controlled Substances

• CI CV based upon potential for abuse
• CI no accepted medical use
• Research is allowed
• Analytical laboratories
• Dog handlers (law enforcement)

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Schedules of Controlled Substances

• 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

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Schedules of Controlled Substances (continued)

• Differences state and federal
• Codeine cough syrups CIV in Missouri
• Ephedrine CIV in Missouri
• Missouri will schedule a substance after DEA does
  unless there is an objection

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Schedules of Controlled Substances (continued)

• Non-controlled abusable agents
• Carisoprodol
• Nalbuphine
• Tramadol
• Advertising not allowed for any schedule

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Registration

• Requirements
• All legitimate controlled substance activities
• Agents excepted pharmacist, nurse, employees
  are not registered
• No registration issued if controlled substance
  conviction
• Misdemeanor 2 years
• Felony 7 years

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Registration (continued)

• Process
• Application, renewal notice
• Notify BNDD of change of name, address, or
  ownership
• Expiration 3 years

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Registration - Discipline

• Administrative
• Warning
• Censure
• Probation
• Suspension
• Revocation
• Denial

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Registration - Discipline

• Criminal
• Federal civil fines, imprisonment
• Refusal to make or keep records is a misdemeanor
• Theft, false prescriptions, and false records are
  felonies.

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Records

• General
• Authority to review by DHSS, Board of Pharmacy,
  law enforcement
• Readily retrievable
• Separate, or
• Electronic or mechanical access, or
• Visually identifiable
• Provide within three (3) working days
• Keep two (2) years (Rxs five (5) years)
• Keep on site, except as allowed

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Records (continued)

• Required information
• Drug name
• Form
• Strength
• Quantity per container
• Number of containers
• Date of transaction
• Name/address of person dispensed to
• Name/initial of person dispensing
• Any other type of disposition
• Goal records are reconcilable

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Records (continued)

• 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

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Records (continued)

• Inventory records
• Annual/biennial
• Opening/close of business day specified
• Exact count CII or if gt 1,000 per container
• Board of Pharmacy requires at PIC change
• Continuous or perpetual
• No requirement except hospital/LTCF (must be
  reconciled periodically)
• Dispensing records
• Will be covered under Prescription Writing and
  Dispensing

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Records (continued)

• Transfer records
• To other pharmacies, physicians, ambulances, etc.
• Use Official Order Form (OOF) for CII
• No borrow loan without record, OOF
• Distributor registration if gt 5 total dosage
  units
• Office use by practitioner cannot obtain with
  prescription

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Records (continued)

• Returns to supplier unusable, expired
• Disposal records
• DEA authorized destroy on site, DEA form
• Reverse distributor
• Hospital pharmacy or patient care areas
• Loss reports

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Security

• Physical security
• Effective controls based on schedules and
  quantities stocked
• CII
• Substantially constructed, securely locked
  cabinet
• Limited access
• LTCF double lock, unless unit dose

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Security (continued)

• Physical security (continued)
• CIII-V
• Allowed to be dispersed in pharmacy
• Locked in all other settings
• Dispensing area security
• Employees
• Family
• Friends

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Security (continued)

• 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

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Security (continued)

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

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Security (continued)

• Reporting losses
• Police
• 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

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Security (continued)

• Reporting losses (continued)
• DEA
• Call immediately
• Form to follow
• Board of Pharmacy
• Notify with annual renewal (BNDD sends a copy of
  pharmacy loss reports to the Board monthly)

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INTERMISSION
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Prescribing

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

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Prescribing (continued)

• 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 (as
  opposed to weaning)
• Exception office-based treatment programs
  buprenorphine
• Using hospital DEA
• Temp license, resident, hospital employee
• Only hospital patients no family, employees,
  friends
• Military

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Prescribing (continued)

• 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
• BNDD registration, no DEA

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Prescription Writing and Dispensing

• 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

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Prescription Writing and Dispensing

• 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

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Prescription Writing and Dispensing

• Ensure Rx is legitimate and properly written
• RPh has corresponding liability with prescriber
• Changes or additions
• Most are allowed after confirming with prescriber
• Changes must be documented
• Changes NOT allowed
• Patient name
• Drug name (except generic substitution)
• Prescriber signature
• Expiration no fill or refill after 6 months
  after date prescribed

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Prescription Writing and Dispensing

• 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
• Confirm prescriber if unknown

44
Prescription Writing and Dispensing

• CII Prescriptions
• Emergency prescriptions (continued)
• Written follow up prescription must be received
  within 7 days to provide authorization for
  emergency dispensing attach to oral Rx
• Notify BNDD and DEA if no written Rx is received

45
Prescription Writing and Dispensing

• CII Prescriptions -- FAX
• Of original, signed prescription
• Receive original prescription before dispensing
• Emergency (same as oral emergency)
• Original not required
• LTCF
• Hospice
• Narcotic injection

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Prescription Writing and Dispensing

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

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Prescription Writing and Dispensing

• CII Prescriptions (continued)
• Computer
• Must receive the original prescription before
  dispensing
• Emergency (same as oral emergency)
• Reduce to writing (printed form) for filing
• Written prescription must be received within 7
  days

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Prescription Writing and Dispensing

• 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

49
Prescription Writing and Dispensing

• CIII-CIV Prescriptions
• Written
• Oral reduce to writing for filing
• FAX
• Telephone number of FAX, date and time of
  transmission on FAX
• File original FAX as prescription
• Prescriber must maintain original prescription on
  file

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Prescription Writing and Dispensing

• CIII-CIV Prescriptions (continued)
• Computer
• Reduce to writing (printed form) for filing
• Verify with prescriber within 30 days by
  telephone or by printout
• Quantity 90 days supply
• Refills
• No more than 5 times within 6 months from Rx date
• Monitor-- for early refills and total use
  compared to dose ordered

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Prescription Writing and Dispensing

• CV Prescriptions
• Same as CIII-CIV
• If prescribed, treat as prescription no refill
  unless authorized
• OTC
• RPh only
• Purchaser must be at least 18 years of age
• Purchaser not known to RPh must provide ID
• Record in bound record book

52
Prescription Writing and Dispensing

• Partial filling CII
• Due to inadequate supply must fill remainder
  within 72 hours or notify prescriber
• LTCF, terminally ill patient
• Record on Rx LTCF or terminal illness
• Record dates/quantities of fills
• No fills after 60 days from Rx date
• Partial filling CIII-IV up to total quantity
  within 6 months

53
Prescription Writing and Dispensing

• DEA Proposed PKI process
• Public key infrastructure (PKI) - Public and
  private IDs
• Positive ID of sender
• Guarantee confidentiality

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Labeling of Prescriptions

• Pharmacy name and address
• Prescriber name
• Patient name
• Directions for use
• Serial (prescription) number
• Date of filling
• CII-CIV -- Caution Criminal offense to
  transfer to person other than patient

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Documentation on Prescriptions

• Required
• RPh signature and date
• Quantity filled if different than prescribed
• Recommended
• Special instructions/communications
• Name of person calling oral prescription

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Prescription Records

• Prescription Files
• Three files required
• CII
• CIII-CV
• Non- Controlled substance
• Refill records
• Manual record on back of Rx
• Computerized records
• All original Rx information
• Refill history
• Daily pharmacist verification printout or log

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Prescription Records

• Transferring Rx to another pharmacy
• One time except if share on-line database
• Record on hard copy except if shared database
• Occurs between two RPhs
• Documentation by transferor
• Writes Void on face of Rx
• Records pharmacy name, address, DEA and RPh
  receiver on reverse of Rx

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Prescription Records

• Transferring Rx to another pharmacy
• Documentation by receiver of transfer
• Transfer on face of Rx
• Original date written
• Original refills authorized
• Original dispensing date
• refills remaining
• Dates of previous fills and locations
• Pharmacy name, address, DEA and transferring RPh

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Delivery by Common Carrier

• Postal regulations
• Prescription properly labeled
• Plain wrapper
• No controlled substance indicators on the
  outside
• Loss report responsibility
• Shipper is responsible

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Prescription Monitoring Programs

• Multiple copy manual systems
• Electronic systems
• 18-20 states
• Federal law proposed in Congress 2002

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Hospitals

• Registration
• As hospital, not as pharmacy
• Administrator signs application as registrant
• Licensing regulations
• DHSS Bureau of Health Facility Regulation
• Center for Medicare and Medicaid Services
• Security
• Locked storage
• Authorized access

62
Hospitals

• Records
• CII routinely reconciled
• CII-CV routinely reconciled outside pharmacy,
  reconcilable inside pharmacy
• Prescribing/ordering
• Written, oral, electronic signature acceptable
• Distribution to patient care areas
• Traditional floor stock
• Automated floor stock
• Discourage patient supply intermingled with other
  drugs

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Hospitals

• ER administering
• Administer on oral order when prescriber not
  present
• Nurse assess patient
• Nurse confirm prescriber/patient relationship
• Narcotic detox/treatment
• If patient in hospital for other medical/surgical
  reasons

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Long Term Care Facilities

• Emergency Kit
• Registration
• LTCF registration, not pharmacy
• No DEA number
• Administrator signs application as registrant
• Pharmacy supplier responsibility
• Assure LTCF has policy and procedure in place to
  address security and record keeping

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Long Term Care Facilities

• Emergency kit (continued)
• Initial stock and replacement stock
• Transfer not patient prescription
• Record keeping
• Transfer record both pharmacy and LTCF
• Accountability records
• Administration records

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Long Term Care Facilities

• Patients own prescriptions
• Written/oral/fax prescriptions usually from
  physicians office
• Physicians order from LTCF to pharmacy
• Nurse call/fax as prescription only if agent of
  physician
• Pharmacist call physician or oral prescription
• Control at facility
• Security all locked, CII double locked unless
  unit dose
• Records all CS reconciled

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Home Health / Hospice

• Patients residence
• Security Access/who can administer
• Records Staff must document CS delivery
• Disposal Agency policy to discuss disposal with
  patient
• Hospice facility
• Registration E-kit or facility
• Security
• E-kit, stock, patient Rxs similar to LTCF /
  hospital
• Special allowance for CS in patients room

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Home Health / Hospice

• Record keeping
• Receiving E-kit, stock, patients own
  prescription
• Reconcile CII each shift, CIII CV daily
• Administration and waste similar to hospital

69
Individual Practitioners

• Licensed by Division of Professional Registration
• Physician
• Dentist
• Veterinarian
• Podiatrist
• Optometrist

70
Individual Practitioners

• Registration
• One registration allows all activities
• Separate registration if has stock at gt1 site
• Free-standing, non-licensed facilities
• Individual practitioner must be registered at the
  location in order to stock CS
• No facility registration
• Physician or hospital owned clinics
• Urgent care centers
• Infusion centers
• Dialysis centers

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Individual Practitioners

• Security
• Locked storage
• Limited access
• Records
• Prescribing
• Administering
• Dispensing
• Receiving
• Inventory
• Other Disposition

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Individual Practitioners

• Prescribing
• Record of all CS Rxs written, including refill
  authorizations
• Rx may be communicated to pharmacy by agent a
  person employed or directly responsible to the
  prescriber
• Dispensing
• CS labeling requirements are similar to pharmacy
  labeling requirements

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Individual Practitioners

• Collaborative practice
• RNs only no LPNs or Pas
• May administer/dispense CS after direct consult
  with physician
• May not prescribe CS, may call CS prescription in
  schedules III-V only at direction of physician

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Listed Chemicals

• Substances
• Precursors to controlled substances
• Ephedrine
• Pseudoephedrine
• Phenylpropanolamine
• Essential chemicals (reagents, solvents)
• Acetone Ethyl Ether
• Iodine Potassium permanganate
• Sulfuric acid Others

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Listed Chemicals

• Registration
• BNDD -- not currently registering
• DEA currently required for some activities
• Reports DEA required based on threshold
  quantities

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Listed Chemicals

• Ephedrine single entity
• No other active medicinal ingredient in
  therapeutic quantity
• C IV in Missouri
• DEA
• Registration
• Records of sales
• Stored behind the counter

77
Listed Chemicals

• Ephedrine combination, pseudoephedrine,
  phenylpropanolamine and combinations
• Missouri Law any methamphetamine precursor drug
• OTC sales
• Maximum of 2 packages (6 total grams) of single
  entity pseudoephedrine or PPA.
• Maximum of 3 packages (9 total grams) of
  combination product
• Must keep single entity product behind the
  checkout counter or within 10 ft and an
  unobstructed view of an attended checkout
  counter.

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Where to Get More Information

• BNDD
• Telephone [phone]
• FAX [phone]
• Board of Pharmacy
• Telephone [phone]
• FAX [phone]
• TDD [phone]
• Drug Enforcement Administration
• Telephone [phone]
• FAX [phone]

79
QUESTIONS