1. Allison Benz, R.Ph., M.S. Director of Professional Services August 10, 2014 Texas State Board of Pharmacy Laws and Rules Update

2. 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

3. 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 – Dallas Alice G. Mendoza, R.Ph. – Kingsville Bradley A. Miller, Ph.T.R. – Austin Phyllis A. Stine – Abilene Joyce Tipton, R.Ph., MBA – Houston Charles F. Wetherbee – Boerne 8/10/2014 3

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

6. Tramadol 8/10/2014 6 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.

7. Tramadol 8/10/2014 7 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.

8. 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 8/10/2014 8

9. Class A Pharmacies

10. 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 8/10/2014 10

11. 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.) 8/10/2014 11

12. 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.) 8/10/2014 12

13. 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.) 8/10/2014 13

14. 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 8/10/2014 14

15. 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.) 8/10/2014 15

16. 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.) 8/10/2014 16

17. 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 8/10/2014 17

18. 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 8/10/2014 18

19. Pharmacists and Pharmacy Technicians

20. 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 8/10/2014 20

21. 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 8/10/2014 21

22. Current Issues

23. 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 8/10/2014 23

24. 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.) 8/10/2014 24

25. 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.) 8/10/2014 25

26. Sterile Compounding

27. 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. 8/10/2014 27

28. Priorities for Inspections Pharmacies that: – Compound High Risk Preparations. – Have had previous non-compliance problems during inspections. – Compound Low and Medium Risk Preparations. 8/10/2014 28

29. 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. 8/10/2014 29

30. 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. 8/10/2014 30

31. 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. 8/10/2014 31

32. 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. 8/10/2014 32

33. 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. 8/10/2014 33

34. 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. 8/10/2014 34

35. 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. 8/10/2014 35

36. Testing of Compounded Products SUMMARY OF COMPOUNDED SAMPLES TESTING PROGRAM FY2009 – FY2013 FY2009FY2010FY2011FY2012FY2013 5-Yr. Avg. Total # Samples Tested468637285851 # Non-Sterile Samples Tested 35582720929.8 # Potency Failures6134215.2 # Sterile Samples Tested11281084921.2 # Potency Failures184123.2 # Sterility Failures0001 ** 0<1 # Fungal Failures * N/A 00 # Endotoxin Failures000000 * Fungal Testing began in FY2013 **Nasal product 36

37. Questions?

38. Thank You!