Report to the Texas Pharmacy Congressaugust 18, 2016

Report to the Texas Pharmacy CongressAugust 18, 2016

TEXAS STATE BOARD OF PHARMACY

REPORT TO THE TEXAS PHARMACY CONGRESS

August 18, 2016

Report to the Texas Pharmacy CongressAugust 18, 2016

I.CURRENT ISSUES.

A.Texas Prescription Monitoring Program.

1.The Timeline for implementation of the program at TSBP has been follows:

November 2015 – RFP for the new PMP issued by TSBP.
January 2016 – Appriss Selected as the Vendor.
February –May 2016 – Program Installation at TSBP.
June – August 2016–Testing of Program.
September 1, 2016 – NEW PMP goes Live.

2.TSBP will also be issuing the official prescription pads to prescribers beginning 9/1/2016.

3.Contact information for the PMP

Email:

Phone: 512-305-8050

B.Sunset Review of the Texas State Board of Pharmacy – The Pharmacy Act and the Board of Pharmacy will be abolished on September 1, 2017, unless they are continued by the 85th Texas Legislature. During the first two Quarters of FY 2016, the Sunset Commission conducted its review of the agency in preparation for a recommendation to the Legislature.The Sunset Staff Report is complete and now available on the Sunset Commission Website at:

TSBP’s “Self-Evaluation”– submitted to the Sunset Commission on August 31, 2015.
October 2015 – March 2016 – Sunset staff reviews the agency.
April 2016 – Sunset Staff Report Published.
June 23, 2016 – Public Hearing to receive comments on the Staff Report.
August 22, 2016 –Hearing scheduled for 9:00 a.m. – The Sunset Commission will make decisions on the TSBP Sunset Report at this meeting.
January – May 2017 – Legislative Session.

C.2017-2018 TSBP Legislative Appropriation Request (LAR)–The Board approved the LAR at the August 2, 2016, meeting and the LAR was submitted on Friday, August 12, 2016.

The Governor, Lieutenant Governor, and the Speaker of the House directed all state agencies to submit a base line budget request that is 4% less that the amount budgeted to TSBP for the FY2016-2017 biennium.
TSBP submitted a budget with a 4% cut as requested – This request was for $575,629 less than the budget for the current biennium. This cut would include:
3 FTEs – 1 in licensing and 2 in enforcement (1 Field Compliance Officer and 1 Field Inspector).
Testing of Compounding Products: Reduce the testing of compounded products by 90%.
Scanning Records: Reductions would increase the amount of paper documents which will require additional storage.
Travel: Eliminating the field FTE’s above, will decrease travel associated with those positions.
Training: Reductions would result in field inspection staff not obtaining needed training
In addition to the budget with the 4% cut, TSBP also submitted a request for additional funding for a number of “Exceptional Items” as follows:
#1 - Restore the 4% Cut$575,629
#2 - Prescription Monitoring Program Increase from FY2017$1,518,117
#3 - Reclassifications & Equity Adjustments$188,332
#4 - Technology$228,820
#5 - Merit Increase for Eligible Classified Employees$410,118
#6 - Vehicle Replacements $132,000
#7 - New Positions (14 see below)$2,032,137
#8 - Annual Leave Pay Out$162,744
#9 - Increase PRN$18,684
#10 - Executive Director Salary Increase$59,076
#11 - Hobby Building Maintenance$200,000

Total Exceptional Items$5,525,657

The 14 new positions include:
1 – Deputy Executive Director (Pharmacist III)
1 – Pharmacist I (Assistant Director of Enforcement)
1 – Compliance Officer (Field) - Pharmacist I
2 –Sr. Inspectors VII (Field)
1 – Field Investigator IV
1 – Program Supervisor III
1 – Program Specialist V
2 – Administrative Assistants V
2 – Investigators IV (Enforcement Officer)
1 – Information Technology Security Analyst III
1 – Attorney IV

D.Pilot Project Approved – The Board approved a Request for a Pilot Project submitted by Baylor Scott and White Pharmacy #201 in Round Rock and Baylor Scott and White Pharmacy #104 in Carrollton. The ScriptCenter Kiosk will be installed at the two locations listed above to give prescription access to employees and discharge patients. Tejas Patel (Round Rock) and Lynne Hoang (Carrollton) will oversee the project and will provide updates to the Board. The reports will include:

Number of prescriptions delivered to patients via ScriptCenter
The time of day that the prescriptions were picked up
Length of time and the specific dates of any system downtime
Any errors associated with ScriptCenter
Results from an on-screen survey to measure patient satisfaction

The time frame for the project will be no more than 18 months from the start of the project, which must occur within 30 days of the Board’s approval. However, the Board may extend the time frame for the project as deemed appropriate by the Board.

E.Task Force on Pharmacy Technician – The Board will be convening a Task Force to review pharmacy technician education training and examination requirements. The Task Force is scheduled to present recommendations to the Board at the February 7, 2017, meeting.

II.ADOPTED & WITHDRAWN RULES (August 2, 2016, Meeting – The rules will become effective inlate September 2016)

ADOPTEDRULES

A.Amendments to §281.8 concerning Grounds for Discipline for a Pharmacy License – The amendments implement the provision of SB 460 that prohibits the waiving, discounting, reducing, or offering to waive, discount, or reduce a patient copayment or deductible for a compounded drug.

B.Amendments to §281.31 concerning Burden of Proof – The amendments clarify the rules for show cause order hearings.

C.Amendments to §281.66 concerning Application for Reissuance or Removal of Restrictions of a License or Registration – The amendments correct grammar in the rule.

D.Amendments to §283.12 and §291.1 concerning Licensing Requirements – The amendmentseliminate the provisions allowing individuals who are unable to obtain a social security number, to provide an individual taxpayer identification number in lieu of a social security number because a social security number is required in order to process criminal background checks.

E.Amendments to §291.33 concerning Operations of Class A Pharmacies– The amendments make a number of “clean-up changes to the rules to make the rules consistent with recent changes to law, e.g., changing the time period for notification of change of location from 10-days to 30-days prior to moving a pharmacy.

F.Amendments to §291.76 and §291.151 concerning Floor Stock Documentation in Class F Pharmacies and Ambulatory Surgical Centers – The amendments allow pharmacists to record certain information in the patient’s chart in lieu of keeping a separate log.

G.Amendments to §291.104 concerning Notification Requirements for Class E Pharmacies Dispensing Controlled Substances to Texas Residents – The amendments update the requirements for Class E pharmacies to submit prescription to the Texas State Board of Pharmacy instead of the Texas Department of Public Safety.

H.Amendments to §291.133 concerning Sterile Compounding – The amendments update the rules with regard to USP <797>.

WITHDRAWN RULE

Amendments to §291.17 Concerning Perpetual Inventory in Class A and Class A-S Pharmacies – The amendments would have required Class A and Class A-S pharmacies to maintain perpetual inventories of Schedule II controlled substances. (Note: New language will be presented to the Board at the November 1, 2016, meeting.)

III.PROPOSED RULES (August 2, 2016, Meeting)

A.Amendments to §281.65 concerning Administrative Penaltyfor Failing to Operate a Pharmacy –

These amendments, if adopted, add an administrative penalty for failing to operate a pharmacy within six months of the date of issuance of the pharmacy license and make minor corrections to the rule.

B.Amendments to §291.34 concerning Schedule IIPrescriptions from Out-of-State Practitioners –

These amendments, if adopted, update the requirements regarding Class A pharmacies dispensing schedule II controlled substance prescriptions issued by prescribers licensed in a state other than Texas to require the plan be approved by the Texas State Board of Pharmacy.

C.Amendments to §291.74 concerning Class C PharmaciesOperated by Management Companies– These amendments, if adopted:

eliminate references to pharmacies operated by management companies since management companies are no longer authorized by DEA;
implement provisions of SB 460 regarding notification for a change of location; and
remove references to Class C-S pharmacy which are no longer necessary.

D.Amendments to §291.155 concerning Class H Pharmacies – The amendments, if adopted, clarify that a licensed Class H pharmacy may continue to operate after a Class A or Class C pharmacy that dispenses to outpatient obtains a license in the county.

E.New Rule §295.14 concerning Pharmacists DispensingOpioid Antagonists – The new rule implements SB 1462, passed during the 2015 TexasLegislative Session allowing pharmacists to dispense naloxone toindividuals under a standing order from a physician.

F.Amendments to §295.16 concerning the Definition of anEpinephrine Auto-Injector– The amendments, if adopted, update the definition of auto-injectors.