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Allison Benz, R.Ph., M.S.
Director of Professional Services
August 10, 2014
Texas State Board of Pharmacy Laws and Rules Update
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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.
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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
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Tramadol
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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.
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Tramadol
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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.
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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
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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.)
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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
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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
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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.)
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Sterile Compounding
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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.
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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
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Questions?
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Thank You!