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

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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

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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

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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)

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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

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Practitioner Impairment

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

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Diversion

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

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Diversion

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

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Diversion

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

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Diversion

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

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Diversion

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

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Drug Diversion

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

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Controlled Substance Schedules

• 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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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

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Controlled Substances Schedules

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

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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.

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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.

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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

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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).

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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

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Registration

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

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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.

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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

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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

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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.

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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.

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Administrative Action Process

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

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Administrative Action Process

• Non-Public discipline
• Letter of Concern
• Letter of Warning
• Letter of Censure
• Public discipline
• Probation
• Revocation / Denial

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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.

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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

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Practitioner Office Records

• Required information
• Drug name
• Form
• Strength
• Quantity per container
• Number of containers

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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

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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

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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

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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

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Security

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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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.

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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

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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

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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

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Prescription Writing

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

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Prescription Writing

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

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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.

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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.

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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.

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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.

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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

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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

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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

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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

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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.

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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

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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

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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

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Summary

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

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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)

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BNDD Contact Information

• Bureau of Narcotics and Dangerous Drugs
• 912 Wildwood, P.O. Box 570
• Jefferson City, MO 65102-0570
• Telephone [phone]
• Facsimile 573-526-2569

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QUESTIONS