Allison Benz, R.Ph., M.S.

Director of Professional Services

August 10, 2014

Texas State Board of Pharmacy Laws and Rules Update

Texas State Board of Pharmacy 8/10/2014

Goals

Review recent changes to pharmacy rules;

Talk about some issues facing the Board; and

Answer your questions.

2

Board of Pharmacy Members

Jeanne D. Waggener, R.Ph. – President – Waco

Dennis F. Wiesner, R.Ph.– Vice President – Austin

Buford T. Abeldt, Sr., R.Ph. – Lufkin –Treasurer

Christopher M. Dembny, R.Ph. – Richardson

W. Benjamin Fry, R.Ph., FIACP, FACA – San Benito

L. Suzan Kedron – DallasAlice G. Mendoza, R.Ph. –

KingsvilleBradley A. Miller, Ph.T.R. –

AustinPhyllis A. Stine – AbileneJoyce Tipton, R.Ph., MBA

– HoustonCharles F. Wetherbee –

Boerne

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Class A (Community) and Class C (Institutional) Pharmacies

Tramadol

8/10/20146

After 1/1/13, tramadol (Ultram®) is required to be inventoried on the initial, annual, change of ownership, and change of PIC inventories.

After 6/1/13 the change of PIC inventory must include all controlled substances, nalbuphine, and tramadol.

Effective August 18, 2014, tramadol will be a Schedule IV Controlled Substance.

Tramadol

8/10/20147

Effective August 18, 2014, tramadol will be a Schedule IV Controlled Substance.

Every DEA registrant possessing tramadol must take an inventory of all tramadol stock.

S.B. 1643 passed by the 2013 Texas Legislature amended the Texas Controlled Substances Act to allow a pharmacy technician working under the supervision of a pharmacist to query the PAT Program for the recent Schedule II-V prescription history of a particular patient.

Note: DPS Published proposed rules to implement this provision in the Texas Register on July 4, 2014.

Delegation of Access to Prescription Access Texas (PAT) System

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Class A Pharmacies

Effective Date: 9/8/2013.

A pharmacy may use a program that automatically refills prescriptions that have existing refills available in order to improve patient compliance with and adherence to prescribed medication therapy.

Auto-Refill Programs

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To enroll patients into an auto-refill program, a pharmacy must give the patient/agent notice about the availability of the program.

The patient/agent must:– Affirmatively indicate that they wish to enroll in such a

program and the pharmacy must document the patients’ indication; and

– Have the option to withdraw from such a program at any time.

Auto-Refill Program (cont.)

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Auto-refill programs may be used for refills of dangerous drugs, and Schedule IV and V controlled substances.

Schedule II and III controlled substances MAY NOT be included in an auto-refill program.

Auto-Refill Program (cont.)

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A DUR must be completed on all prescriptions including those in the Auto-Refill program.

Special attention must be noted for DUR warnings of duplication of therapy and all conflicts must be resolved with the prescribing practitioner prior to refilling the prescription.

Auto-Refill Program (cont.)

8/10/201413

Effective Date: 9/8/2013.

A verbal prescription transfer must now be communicated directly between a: – Pharmacist and another pharmacist; or– Pharmacist and an intern (Note: Only one of the

individuals involved in a prescription transfer may be an intern).

Prescription Transfer Requirements

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Both the individual transferring and the individual receiving the prescription must engage in a confirmation or double check of the prescription information using steps such as: – The transferring individual sending fax of the hard copy

prescription to the receiving individual; or – The receiving individual repeating the verbal

information received from transferring individual and the transferring individual verbally confirming information is correct.

Prescription Transfer Requirements (cont.)

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An individual may not refuse to transfer a prescription to another individual who is acting on behalf of a patient.

The transfer of original prescription information must be completed in a TIMELY manner.

Prescription Transfer Requirements (cont.)

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Effective Date: 3/26/14.

The ratio for pharmacists to pharmacy technicians in Class A and Class B pharmacies was increased to 1:4; and

The ratio in Class G pharmacies was increased to 1:8.

Ratio of Pharmacists to Pharmacy Technicians

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S.B. 869 passed by the 2013 Texas Legislature amended the Pharmacy Act to delete the requirement for pharmacists to notify a practitioner when they substitute a dosage form.

Notification When Substituting Dosage Forms

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Pharmacists and Pharmacy Technicians

Effective Date: 3/17/2013.

Pharmacists can receive credit for programs approved by AMA as Category 1 CME.

Pharmacists must report 1-hour of CE related to Texas Pharmacy Laws or Regulations on renewals received after 1/1/15.

Pharmacist’s Continuing Education

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Effective Date: 6/12/2013.

Pharmacy Technicians must report 1-hour of CE related to Texas Pharmacy Laws or Regulations on renewals received after 1/1/15.

Pharmacy Technician Continuing Education

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Current Issues

At their December meeting, the Texas Medical Board reviewed Section 157.0511 (b)(2) of the Medical Practices Act that reads:– the prescription, including a refill of the prescription, is

for a period not to exceed 90 days.

TMB has determined that this section means that “an APRN or PA may issue prescriptions for a total of 90-days’ supply of a controlled substance including refills. 

Schedule III – V Controlled Substance Rxs from APRNs and PAs

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TMB stated that the intent of the section is to allow 90-days’ supply and not to limit the patient to one refill.

This means the APRN or PA could issue a prescription with more than one refill provided the total quantity does not exceed more than a 90-day supply.

Schedule III – V Rxs from APRNs and PAs (cont.)

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Further discussions with staff of the Medical Board have also resulted in the interpretation that essentially a controlled substance prescription issued by an APRN or PA, expires 90-days after issuance.

Schedule III – V Rxs from APRNs and PAs (cont.)

8/10/201425

Sterile Compounding

Fungal Meningitis Outbreak

New England Compounding Center (NECC) in Framingham, MA

As of October 23, 2013 –– 20 states had reported cases.– 751 cases of fungal infections. – 64 deaths.

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Priorities for Inspections

Pharmacies that:– Compound High Risk Preparations.– Have had previous non-compliance problems during

inspections.– Compound Low and Medium Risk Preparations.

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Experiences

As a result of recent inspections, 2-pharmacies were ordered to cease compounding of High-Risk preparations.

Tools Available to TSBP “shut down” compounding operations:– Issuance of a “Warning Notice” with immediate due-

date (voluntary compliance).– Summary Suspension of a license.

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2013 Texas Legislative Session

The Texas Pharmacy Act was amended by SB 1100 to specify that:– New pharmacies that compound sterile preparations

may not be licensed by TSBP until the pharmacy has: been inspected to ensure the pharmacy meets the

requirements of TSBP laws and rules; and reimbursed the Board for all expenses incurred in inspecting

the pharmacy, if the pharmacy is located in another state.

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2013 Texas Legislative Session (cont.)

The Texas Pharmacy Act was amended by SB 1100 to specify that:– Existing pharmacies that compounding sterile

preparations may not renew their registration unless the pharmacy has:

been inspected to ensure the pharmacy meets the requirements of TSBP laws and rules; and

reimbursed the Board for all expenses incurred in inspecting the pharmacy, if the pharmacy is located in another state.

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2013 Texas Legislative Session (cont.)

The Texas Pharmacy Act was amended by SB 1100 to specify that:– A pharmacy that compounds a sterile product must

notify the Board: Immediately of any adverse effects reported to the pharmacy

or known by the pharmacy to be potentially attributable to a sterile product compounded by the pharmacy; and

Not later than 24-hours after the pharmacy issues a recall for a sterile product compounded by the pharmacy.

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2013 Texas Legislative Session (cont.)

Through SB 1 TSBP was given additional appropriations to:– Hire 6 additional personnel directly related to the

inspection pharmacies that compound sterile preparations; and

– Additional funding to test sterile preparations compounded by pharmacies.

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Actions Since 2013 Session

New rules for the operation of pharmacies that compound sterile preparations became effective 12/10/13.

A new license designation has been created for pharmacies that compound sterile products.

A new inspection form has been developed and is in use.

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Actions Since 2013 Session (cont.)

TSBP has hired 5 new inspectors and 1 administrative person to assist with inspections.

By 9/30/2014, all inspectors will have received additional training for the inspecting of pharmacies that compound sterile preparations.

8/10/201435

Testing of Compounded ProductsSUMMARY OF COMPOUNDED SAMPLES TESTING PROGRAM

FY2009 – FY2013

FY2009 FY2010 FY2011 FY2012 FY20135-Yr. Avg.

Total # Samples Tested 46 86 37 28 58 51

# Non-Sterile Samples Tested

35 58 27 20 9 29.8

# Potency Failures 6 13 4 2 1 5.2

# Sterile Samples Tested 11 28 10 8 49 21.2

# Potency Failures 1 8 4 1 2 3.2

# Sterility Failures 0 0 0 1** 0 <1

# Fungal Failures* N/A N/A N/A N/A 0 0

# Endotoxin Failures 0 0 0 0 0 0

*Fungal Testing began in FY2013 **Nasal product36

Questions?

Thank You!