HEB Pharmacy Conference October 25, 2014

Transcription

1 Texas State Board of Pharmacy Laws and Rules Update Allison Benz, R.Ph., M.S. Director of Professional Services Central Texas Society of Health-System Pharmacists Annual Seminar October 25, 2014 Texas State Board of Pharmacy 1

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. 8 Texas State Board of Pharmacy 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 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. Tramadol became a schedule IV controlled substance on August 18, Texas State Board of Pharmacy 2

3 Delegation of Access to Prescription Access Texas (PAT) System S.B 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 adopted rules to implement this provision in the Texas Register on August 29, 2014 (effective September 7, 2014). Class A Pharmacies Notification When Substituting Dosage Forms Effective Date: September 1, 2013 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. Rules were adopted by the Board at the August 5, 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. 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. Texas State Board of Pharmacy 3

4 Current Issues Schedule III V Controlled Substance Rxs from APRNs and PAs At their December 2013, meeting, the Texas Medical Board reviewed Section (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 Rxs from APRNs and PAs (cont.) 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.) 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. Hydrocodone Combination Products (HCP) Move to CII On 10/6/2014, all hydrocodone combination products will become schedule II controlled substances. Pharmacists are allowed to dispense any refills authorized on HCP prescriptions issued prior to 10/6/2014. Pharmacies must take an inventory of HCP on 10/6/2014. DEA Regulations on Disposal of Controlled Substance Effective Date: October 9, Authorizes certain DEA registrants, including pharmacies to become authorized collectors (Note: this will require modification of the DEA registration to obtain authorization to be a collector). Authorizes pharmacies to operate collection receptacles at long-term care facilities. Texas State Board of Pharmacy 4

5 Sterile Compounding Fungal Meningitis Outbreak 2012 New England Compounding Center (NECC) in Framingham, MA As of October 23, states had reported cases. 751 cases of fungal infections. 64 deaths. Priorities for Inspections Experiences Pharmacies that: Compound High Risk Preparations. Have had previous non-compliance problems during inspections. Compound Low and Medium Risk Preparations. 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 Texas Legislative Session 2013 Texas Legislative Session (cont.) 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. 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. Texas State Board of Pharmacy 5

6 2013 Texas Legislative Session (cont.) 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. 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-S, C-S, E-S. A new inspection form has been developed and is being tested. 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. Testing of Compounded Products SUMMARY OF COMPOUNDED SAMPLE TESTING PROGRAM FY 2009 FY 2013 FY2009 FY2010 FY2011 FY2012 FY Yr. Avg. Total # Samples Tested # Non-Sterile Samples Tested # Potency Failures # Sterile Samples Tested # Potency Failures # Sterility Failures ** 0 <1 # Fungal Failures * N/A N/A N/A N/A 0 0 # Endotoxin Failures * Fungal Testing began in FY2013 **Nasal product Federal Drug Quality and Security Act (DQSA) Texas State Board of Pharmacy 6

7 Drug Quality and Security Act (DQSA) Section 503A Pharmacy Compounding Signed into law on November 27, Title I Compounding Quality Act. Section 503A Pharmacy Compounding. Section 503B Outsourcing Facilities. Section 503A was amended to remove the advertising and solicitation provisions that were struck down as unconstitutional by the U.S. Supreme Court in With these provisions removed, this 1997 law will now become effective. 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; Labeling with adequate directions for use; and Compliance with Current Good Manufacturing Practices (CGMP). 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. Texas State Board of Pharmacy 7

8 Task Force on Pharmacy Technicians In November 2013, the Board directed staff to establish a Task Force on Pharmacy Technicians. Task Force on Pharmacy Technicians (cont.) Task Force on Pharmacy Technicians (cont.) 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. The Task Force met on: January 14, 2014; and March 19, The Recommendations of the Task Force were 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. 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. Texas State Board of Pharmacy 8

9 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. 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. 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. Suggestions for Law Changes during the 2015 Legislative Session Effective Date: March Class A and B Pharmacies ratio of pharmacists to pharmacy technicians is increased to 1:4. Class G Pharmacies ratio of pharmacists to pharmacy technicians is increased to 1:8. Texas State Board of Pharmacy 9

10 Suggestions for Law Changes 2015 Legislative Session Suggestions for Law Changes (cont.) Self-Directed Semi-Independent Agency Status. Transfer the prescription monitoring program to TSBP. Amend the Pharmacy Act to allow the TSBP access to financial records. Expand the Board s inspection authority to include the ability copy and inspect the records of a pharmacist practicing outside a pharmacy. Eliminate the requirement for posting the Generic Substitution Sign and modify the requirement for the Complaint Notification to allow posting on an electronic bulletin board. Allow TSBP to close a pharmacy automatically if the pharmacy is: not open within a reasonable time after the license has been issued; or no longer operating. Suggestions for Law Changes (cont.) Class E (Out-of-State) Pharmacies: Require a Class E pharmacy to have a PIC who is licensed as a pharmacist in Texas; Prohibit a person who has had a pharmacist s license revoked, suspended, restricted, surrendered in another state from being an owner of a Class E Pharmacy. Allow the Board to discipline of a Class E pharmacy license if they have been disciplined for violating laws in their state. New Address and New Look for the TSBP Website Texas State Board of Pharmacy 10

11 Questions? Thank You! Texas State Board of Pharmacy 11