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?