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CONTROLLED SUBSTANCES LAWS AND REGULATIONS
Presented by Susan McCann, R.Ph. Administrator, BNDD Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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: >2 million When most people hear the term “drug abuse” they think of illicit drugs. To a greater extent every year, the term is coming to mean abuse of prescription drugs as well. Prescription controlled substances are easy to obtain. There is no concern about the content. In spite of the recent rash of counterfeit prescription drugs, an individual obtaining a prescription controlled substance can feel secure that they know exactly what they’re getting, the strength, and the expected response to taking the medication. Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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%). See update below… An estimated 6.2 million persons, or 2.6 percent of the population aged 12 or older, were current users of psychotherapeutic drugs taken non-medically. An estimated 4.4 million used pain relievers, 1.8 million used tranquilizers, 1.2 million used stimulants, and 0.4 million used sedatives. In 2002, approximately 1.9 million persons aged 12 or older had used OxyContin non-medically at least once in their lifetime. LEST YOU THINK THAT THE ONLY WAY THIS WILL IMPACT YOU IS THROUGH THE PATIENTS THAT YOU SERVE… next slide Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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Drug Diversion Occurs from all levels of controlled distribution
Manufacturers Distributors Pharmacies Hospitals Ambulances Physician offices, etc. Long term facilities – emergency supply and resident prescriptions – Theft of resident prescriptions is reported to law enforcement as the CS were the property of the patient when stolen. Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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Drug Diversion (continued)
Persons responsible Pharmacists Physicians Nurses Pharmacy technicians Family members Office staff Custodians Patients, etc. Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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Drug Diversion (continued)
Methods of diversion Theft Opportunistic Planned access Break-ins Robberies Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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. Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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Department of Health and Senior Services BNDD
Organization/staffing Registrations Inspections/investigations Administrative actions Education Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 History of Controlled Substances Act Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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References for Laws and Regulations
DHSS Board of Pharmacy Drug Enforcement Administration Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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) Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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Schedules of Controlled Substances (continued)
Non-controlled abusable agents Carisoprodol Nalbuphine Tramadol Advertising – not allowed for any schedule Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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Registration (continued)
Process Application, “renewal” notice Notify BNDD of change of name, address, or ownership Expiration 3 years Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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Registration - Discipline
Administrative Warning Censure Probation Suspension Revocation Denial Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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. Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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Records (continued) Inventory records Dispensing records
Annual/biennial Opening/close of business day specified Exact count: CII or if > 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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 > 5% total dosage units Office use by practitioner – cannot obtain with prescription Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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) Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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INTERMISSION Missouri Bureau of Narcotics and Dangerous Drugs
11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 # Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 # Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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. Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 ** Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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Prescription Writing and Dispensing
DEA Proposed PKI process Public key infrastructure (PKI) - Public and private IDs Positive ID of sender Guarantee confidentiality Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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” Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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Prescription Monitoring Programs
Multiple copy manual systems Electronic systems 18-20 states Federal law proposed in Congress 2002 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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Hospitals Registration Licensing regulations Security
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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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Hospitals Records Prescribing/ordering
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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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Hospitals ER administering Narcotic detox/treatment
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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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Long Term Care Facilities
Patient’s own prescriptions Written/oral/fax prescriptions – usually from physician’s office Physician’s 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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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Home Health / Hospice Patient’s residence Hospice facility
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 patient’s room Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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Home Health / Hospice Record keeping
Receiving – E-kit, stock, patient’s own prescription Reconcile CII each shift, CIII – CV daily Administration and waste similar to hospital Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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Individual Practitioners
Licensed by Division of Professional Registration Physician Dentist Veterinarian Podiatrist Optometrist Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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Individual Practitioners
Registration One registration allows all activities Separate registration if has stock at >1 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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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Individual Practitioners
Security Locked storage Limited access Records Prescribing* Administering* Dispensing* Receiving Inventory Other Disposition Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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Listed Chemicals Registration
BNDD -- not currently registering DEA – currently required for some activities Reports – DEA required based on threshold quantities Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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 Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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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. Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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Where to Get More Information
BNDD Telephone: (573) FAX: (573) Board of Pharmacy Telephone: (573) FAX: (573) TDD: (800) Drug Enforcement Administration Telephone: (913) FAX: (913) Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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QUESTIONS Missouri Bureau of Narcotics and Dangerous Drugs 11/18/2018
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