law basics- a focus on the texas controlled substance act...• compounded narcotic controlled...
TRANSCRIPT
PHARMACY
Sarah Redmond, PharmDPGY2 Health-Systems Pharmacy Administration ResidentTexas Children’s Hospital
LAW BASICS: A FOCUS ON THE TEXAS CONTROLLED SUBSTANCE ACT
PHARMACY
The following declare they have no relevant financial interest in relation to this activity
• Sarah Redmond, presenter
• Thuy Nguyen, reviewer
• Susan Powers, CE administrator• Sara Bork, CE reviewer
DISCLOSURE
PHARMACY
1. Discuss controlled substance schedules as set by the Drug Enforcement Administration and Texas Controlled Substance Act
2. Discuss appropriate prescribing of controlled substances as stated in the Texas Controlled Substance Act
3. Describe appropriate acquisition, storage, and disposal of controlled substances
LEARNING OBJECTIVES
PHARMACY
• Texas Administrative Code• Texas State Board of Pharmacy Rules, Title 22, Part 15
• Texas Controlled Substance Act• Texas Health and Safety Code, Chapter 481
• Code of Federal Regulations: Title 21 United States Code Controlled Substance Act
CONTROLLED SUBSTANCE LAWS
PHARMACY
A substance, including a drug, an adulterant, and a dilutant, listed in Schedules I through V or Penalty Group 1, 1-A, 2, 2-A, 3, or 4
• As defined by: • Federal- US Attorney General
• Texas- Commissioner of the Texas Department of State Health Services
SCHEDULED SUBSTANCES
Title 21 Code of Federal Regulations. Sec. §811Texas Controlled Substance Act. Sec.A481.034.A
PHARMACY
Schedule DescriptionI High potential for abuse, no current accepted medical use
II High potential for abuse- may lead to severe physical or psychological dependence, accepted for medical use with restrictions
III Less potential for abuse- may lead to moderate/low physical or high psychological dependence
IV Lower potential for abuse- may lead to limited physical or psychological dependence
V Low potential for abuse- may lead to limited physical or psychological dependence
CRITERIA FOR SCHEDULING
Texas Controlled Substance Act. Sec.A481.035
PHARMACY
A new drug has come to market. It has a moderate potential for abuse and may lead to low physical but high psychological dependence. What schedule do you anticipate the new drug being assigned?
a) Ib) IIc) IIId) IVe) Vf) Not scheduled
CHECK YOUR KNOWLEDGE: SCHEDULES
PHARMACY
A new drug has come to market. It has a moderate potential for abuse and may lead to low physical but high psychological dependence. What schedule do you anticipate the new drug being assigned?
a) Ib) IIc) IIId) IVe) Vf) Not scheduled
CHECK YOUR KNOWLEDGE: SCHEDULES
PHARMACY
• Must register with Drug Enforcement Administration (DEA) and Texas Department of Public Safety (TDPS)• Manufacture, distribute, dispense, prescribe, conduct research
• Intern/residents can use hospital DEA number but hospital must assign a specific intern code to each person
• Pharmacists and nurses are exempt in their usual course of business as employees of a registrant
REGISTRATION REQUIREMENTS
Texas Controlled Substance Act. Sec. 481.061
PHARMACY
• Start with “A” “B” “F” “G” “M”
• Second letter is first letter of last name (or pharmacy/hospital name)
• Step 1: Add 1st, 3rd, and 5th digit
• Step 2: Add 2nd, 4th, and 6th digit, multiply by 2
• Add step 1 and 2
• Last digit of sum will be last digit of DEA number
CHECK A DEA NUMBER
PHARMACY
BS521748
CHECK YOUR KNOWLEDGE: DEA NUMBER
PHARMACY
ü Start with Bo Second letter is first letter of last name • Step 1: Add 1st, 3rd, and 5th digit 5+1+4=10• Step 2: Add 2nd, 4th, and 6th digit, multiply by 2 2+7+8=17 x2=34• Add step 1 and 2 10+34=44
o Last digit of sum will be last digit of DEA number 4≠8
CHECK YOUR KNOWLEDGE: DEA NUMBER: BS521748
PHARMACY
• Electronically through Electronic Prescribing of Controlled Substances (EPCS) certified software
• Official prescription forms• Blue, State of Texas seal• Control number• Pantograph• Thermochromic ink• Watermark
TRANSMITTING PRESCRIPTIONS
Texas State Board of Pharmacy. CII Prescription Form FAQ's Version II
PHARMACY
Official prescription forms can be ordered from the Texas State Board of Pharmacy.
A. True
B. False
CHECK YOUR KNOWLEDGE: OFFICIAL PRESCRIPTION FORM
PHARMACY
Official prescription forms can be ordered from the Texas State Board of Pharmacy.
A. True
B. False
CHECK YOUR KNOWLEDGE: OFFICIAL PRESCRIPTION FORM
PHARMACY
• Prescription must have a valid medical purpose and in the course of medical practice
• A corresponding responsibility rests with the pharmacist who fills the prescription
PHARMACISTS’ RESPONSIBILITY
Texas Controlled Substance Act. Sec.A481.071.Title 21 Code of Federal Regulations. Sec. 1306.04
PHARMACY
• Refills are not allowed
• Multiple 30-day scripts written on the same day are allowed, if the total amount does not exceed 90 days
• Must be filled within 21 days from date of issue or first date authorized to fill
• Partial fills are allowed, if completed within 72 hours
C-II LIMITATIONS
Texas Controlled Substance Act. Sec.A481.074.
PHARMACY
• A pharmacist can never change the following on a C-II prescription:• Patient name
• Medication name (including Route)
• Prescriber name
• Date of issue
C-II LIMITATIONS
Texas Administrative Code. Rule §315.8
PHARMACY
• Refills limited to 6 months after date of issue or 5 times• Natural disaster: pharmacist may dispense not more than a
30-day supply of a prescription drug, other than a C-II if:• Failure to refill might result in interruption of therapy or patient
suffering• Unable to contact provider• Governor has declared a state of disaster• Texas State Board of Pharmacy has notified pharmacies that this is
allowed
C-III-V LIMITATIONS
Texas Controlled Substance Act. Sec.A481.074.
PHARMACY
• Compounded narcotic controlled substances• Concentration no greater than 20%
• Must be with one or more non-narcotic therapeutic agents
COMPOUNDED CONTROLLED SUBSTANCES
Codeine (MUST have Rx) OpiumC-V limit 200mg/100mL 50mg/100mLC-III limit 1.8g/100mL and 90g/unit 500mg/100mL and 25mg/unit
Texas Controlled Substance Act. Sec.A481.105. Sec.A481.104.A
PHARMACY
• Schedule II- DEA 222 form or digital certificates• 3 copies- Brown (supplier), Green (DEA), Blue (purchaser)
• Controlled Substance Ordering System (CSOS)
• Schedule III-IV- Invoice• Invoice must be initialed and dated by receiving RPh
• Transfers- 5% rule• Use DEA 222 form for C-II
ORDERING AND TRANSFERRING
Title 21 Code of Federal Regulations §1305
PHARMACY
DEA FORM 222
Accessed 21 May 18: www.rx-wiki.org
PHARMACY
• Required to store C-II in locked secure cabinet
• Institutional and freestanding ER only
• May store by dispersal throughout non-controlled stock
• May NOT store all controlled substances on one unsecured shelf
STORAGE AND SECURITY
Texas Administrative Code. §291.74 Operational Standards
PHARMACY
Which DEA form is used to report significant theft or loss of controlled substances?
a) 41
b) 222
c) 106
d) 56
CHECK YOUR KNOWLEDGE: DEA FORMS
PHARMACY
Which DEA form is used to report significant theft or loss of controlled substances?
a) 41
b) 222
c) 106
d) 56
CHECK YOUR KNOWLEDGE: DEA FORMS
PHARMACY
Individual employees are REQUIRED to report any diversion by other employees to a
responsible security official of the employer
YOUR RESPONSIBILITY: REPORT DIVERSION
Title 21 Code of Federal Regulations §1301.91
PHARMACY
Each pharmacist on duty shall be responsible for the security of the institutional pharmacy, including provisions for adequate
safeguards against theft or diversion of dangerous drugs, controlled substances, and records for such drugs.
YOUR RESPONSIBILITY: REPORT DIVERSION
Texas Administrative Code RULE §291.74
PHARMACY
• An initial notification to the DEA must be submitted immediately, without delay, upon discovery of theft or significant loss
• DEA form 106 must be submitted within 30 days of discovery• Encouraged to submit electronically
• Can edit with more information after initial submission
REPORTING A DIVERSION
Title 21 Code of Federal Regulations §1301.91
PHARMACY
DEA FORM 106
Accessed 21 May 18: www.rx-wiki.org
PHARMACY
• On-site destruction• DEA form 41 submitted 2 weeks before destruction
• Witnesses required
• Reverse distribution• Documented via invoice or DEA 222 form
DISPOSAL AND DESTRUCTION
Title 21 Code of Federal Regulations
PHARMACY
• Annual inventory of all medications for Texas State Board of Pharmacy (TSBP)
• Exact counts required for all schedule II medications
• Estimated counts allowed for schedule III-V
• Unless container holds more than 1000 tablets/capsules
• Must be signed by the pharmacist-in-charge (PIC) and notarized within 3 days of the inventory
INVENTORY REQUIREMENTS
Texas Administrative Code. §291.17 Inventory Requirements
PHARMACY
• Required for C-II medications in institutions (Class C)
• Required for all controlled substances in:• Remote locations
• Ambulatory surgery centers
• Freestanding ERs
PERPETUAL INVENTORIES
Texas Administrative Code. §291.17 Inventory Requirements
PHARMACY
• Maintain records for 2 years
• DEA 222 forms (also 41, 106)
• Supplier invoices
• Inventories
RECORDS
• Dispensing records
• 3 file storage system
• Schedule II
• Schedule III-V
• Non- scheduled
Texas Controlled Substance Act. Sec.A481.067.A
PHARMACY
• Controlled substances are categorized into schedules
• Prescribers must be registered with the DEA and TDPS• Texas has specific limits on C-II prescriptions
• DEA forms should be used for ordering and transferring C-IIs
• Perpetual inventories are required for C-IIs in hospitals
SUMMARY
PHARMACY
1. Discuss controlled substance schedules as set by the Drug Enforcement Administration and Texas Controlled Substance Act
2. Discuss appropriate prescribing of controlled substances as stated in the Texas Controlled Substance Act
3. Describe appropriate acquisition, storage, and disposal of controlled substances
LEARNING OBJECTIVES
PHARMACY
COMMENTS/QUESTIONS?