Board of Pharmacy Update Gay Dodson, R.Ph. Executive Director/Secretary Texas Pharmacy Association s Annual San Marcos August 1, 2014 2 Goals Review recent changes to pharmacy rules; Talk about some issues facing the Board; Review some possible legislation that may be introduced during the 2015 Legislative Session; and Answer your questions. 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 3 4 Class A (Community) and Class C (Institutional) Pharmacies Tramadol 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. 6 1
Class A Pharmacies Prescriber Consultation on a Prescription Effective Date: 6/12/2013. Prior to dispensing a prescription a pharmacist must resolve any questions regarding the prescription with the prescriber. The pharmacist must document the consultation on the hard-copy prescription or in the pharmacy's data processing system. 8 Prescriber Consultation on a Prescription (cont.) The following information must be included in the documentation of the consultation: Date the prescriber was consulted; Name of the person communicating the prescriber's instructions; Any applicable information pertaining to the consultation; and Initials or identification code of the pharmacist performing the consultation. Prescription Label Effective Date: 6/12/2013. The prescription label is now required to have ONLY the name of the prescriber who signed the prescription. Note: If the prescription is signed by a PA, APN, or RPh the name of the supervising physician is no longer required to be on the Rx label.) The name of the supervising physician is still required to be on the prescription. 9 10 Auto-Refill Programs Auto-Refill Program (cont.) 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. 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. 11 12 2
Auto-Refill Program (cont.) 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.) 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. 13 14 Prescription Transfer Requirements Prescription Transfer Requirements (cont.) 15 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). 16 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.) Ratio of Pharmacists to Pharmacy Technicians 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. 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. 17 18 3
Notification When Substituting Dosage Forms Delegation of Access to Prescription Access Texas (PAT) System 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. 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. 19 20 Pharmacists and Pharmacy Technicians Pharmacist s Continuing Education 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. 22 Pharmacy Technician Continuing Education 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. Current Issues 23 4
Schedule III V Controlled Substance Rxs from APRNs and PAs Schedule III V Rxs from APRNs and PAs (cont.) 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. 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. 25 26 Schedule III V Rxs from APRNs and PAs (cont.) Sterile Compounding 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. 27 28 Fungal Meningitis Outbreak After NECC Job #1. 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. Identify pharmacies that compound sterile products. Revise licensing system to specifically identify those pharmacies that compound sterile products. Conduct priority inspections of sterile compounding pharmacies, especially those involved in compounding high risk level preparations. 29 30 5
Compounding Pharmacies Licensed by TSBP* Priorities for Inspections # Pharmacies that Compound Sterile Products # Pharmacies that Compound Low Risk Products # Pharmacies Located in Texas # Pharmacies Located Outof-State Total 684 221 905 525 173 698 Pharmacies that: Compound High Risk Preparations. Have had previous non-compliance problems during inspections. Compound Low and Medium Risk Preparations. # Pharmacies that Compound Medium Risk Products 442 155 597 31 # Pharmacies that Compound High Risk Products * Estimates based on a survey in 11/12 114 127 241 32 Experiences 2013 Texas Legislative Session 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 duedate (voluntary compliance). Summary Suspension of a license. 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. 33 34 2013 Texas Legislative Session (cont.) 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. 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. 35 36 6
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. 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. 37 38 Actions Since 2013 Session (cont.) TSBP has hired 5 new inspectors. By 9/30/2014, all inspectors will have received additional training for the inspecting of pharmacies that compound sterile preparations. 40 Testing of Compounded Products SUMMARY OF COMPOUNDED SAMPLE TESTING PROGRAM FY 2009 FY 2013 FY2009 FY2010 FY2011 FY2012 FY2013 5-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 product Drug Quality and Security Act (DQSA) Signed into law on November 27, 2013. Title I Compounding Quality Act. Section 503A Pharmacy Compounding. Section 503B Outsourcing Facilities. Section 503A Pharmacy Compounding Section 503A was amended to remove the advertising and solicitation provisions that were struck down as unconstitutional by the U.S. Supreme Court in 2002. With these provisions removed, this 1997 law will now become effective. 7
Section 503A Pharmacy Compounding (cont.) Section 503A Pharmacy Compounding (cont.) 503A exempts pharmacy compounding from compliance three sections of the Federal law that manufacturers are required to meet: FDA approval of products prior to marketing; Compliance with Current Good Manufacturing Practices (CGMP); and Labeling with adequate directions for use. Pharmacy compounders: Are licensed as a pharmacy by a state; and May compound prescription drugs: Pursuant to a prescription for an individual patient; and In limited quantities, in anticipation of the receipt of a prescription. Section 503B Outsourcing Facilities Section 503B Outsourcing Facilities (cont.) An outsourcing facility: will qualify for exemptions from the: FDA approval requirements; and requirement to label products with adequate directions for use; but not the exemption from CGMP requirements. Outsourcing facilities: Will be registered by FDA; Must comply with CGMP requirements; Will be inspected by FDA according to a risk-based schedule; and Must meet certain other conditions, such as reporting adverse events and providing FDA with certain information about the products they compound. Task Force on Pharmacy Technicians (cont.) In November 2013, the Board directed staff to establish a Task Force on Pharmacy Technicians. The Task Force was charged with: reviewing the current laws and rules relating to technicians in Texas; reviewing literature and studies regarding the changing roles and duties of pharmacists and how these changes may impact the role of technicians; and making recommendations to the Board for any changes to the current technician laws and rules to allow technicians to assist pharmacists in providing safe and quality pharmaceutical care to the citizens of Texas. 47 48 8
Task Force on Pharmacy Technicians (cont.) The Task Force met on: January 14, 2014; and March 19, 2014. The Recommendations of the Task Force will be presented to the Board at their May 6, 2014 meeting. Recommendations The Board should continue requiring pharmacy technicians to take and pass one national certification examination. The Board should allow a Technician Trainee to renew their registration once so that their total time as a Technician Trainee will be 4-years rather than the current 2-years. 49 50 The Board should review the definition of the definition of a pharmacy technician to better define what non-judgmental duties are and seek legislation to amend this definition in the Pharmacy Act. The Board shall establish a training program that the technician must complete prior to completing expanded duties. A technician may perform expanded duties provided the: technician completes Board established on-the-job training; training is documented by the PIC; and pharmacist on duty allows the technician to perform the expanded duties while that pharmacist is working. 51 52 The Board should allow training exemptions from required training for expanded duties for technicians in rural areas. The Board should establish a method to grandfather currently registered technicians from the requirement to have completed an ASHP accredited technician education program after 2020 when PTCB will require completion of this program prior to taking the PTCB exam. The Board should amend rules or seek legislation if necessary to expand the duties of technicians to include: Expanding Tech Check Tech in hospital pharmacies and allowing Tech Check Tech in community pharmacies for such duties as: Stocking medication carts; Checking the prepacking of drugs; and Stocking automated dispensing systems. 53 54 9
Expand the duties of technicians to include: Allowing technicians to: transfer refill prescriptions for dangerous drugs. data enter prescriptions in an area other than the prescription department prior to the opening of the pharmacy). perform a final check on a refilled prescription (Note: DUR by pharmacist will still be required). The task force members support the elimination of the ratio of pharmacists to technicians. 55 56 Sign-up to Receive News and Updates from TSBP 58 59 60 10
Questions? 61 Thank You! 11