Texas Pharmacy Law Update Speaker Disclosure Allison Vordenbaumen Benz, R.Ph., M.S. Executive Director/Secretary Texas Chapter of the American Society of Consultant Pharmacists January 27, 2018 The presenter has no actual or potential conflict of interest related to this presentation. The speaker has no financial relationships with regard to this presentation to disclose. Goals Identify recent changes in Texas pharmacy rules; Discuss the emergency kit rules for LTC facilities; and Discuss legislation passed by the 2017 Texas Legislature that affects practice of pharmacy and the Board of Pharmacy. Board of Pharmacy Members Jeanne D. Waggener, R.Ph. President Waco Jenny Downing Yoakum, R.Ph. Vice-President Kilgore Bradley A. Miller, Ph.T.R. Treasurer Austin Buford T. Abeldt, Sr., R.Ph. Lufkin Christopher M. Dembny, R.Ph. Richardson L. Suzan Kedron Dallas Alice G. Mendoza, R.Ph. Kingsville Phyllis A. Stine Abilene Chip Thornsburg San Antonio Suzette Tijerina, R.Ph. Castle Hills Dennis F. Wiesner, R.Ph. Austin Recently Adopted Rules 5 Texas State Board of Pharmacy 1
Pharmacy Technician Registration Requirements At the February 2, 2017, meeting, the Board approved the ExCPT examination for pharmacy technician registration beginning September 1, 2017. Pharmacy Technician Registration Requirements Effective Date: March 19, 2017. Amends the exam requirements for initial registration to specify that the applicant must have taken and passed a pharmacy technician certification examination approved by the board and have a current certification certificate. (Note: Reference to PTCB has been removed.) Board Rule 295.14 Effective Date: December 19, 2016 Dispensing of Opioid Antagonist by Pharmacist Allows a pharmacist to dispense an opioid antagonist under a valid prescription, including: Board Rule 295.14 prescription issued by a standing order, to: a person at risk of experiencing an opioidrelated drug overdose; or a family member, friend, or other person in a position to assist a person at risk of experiencing an opioid-related drug overdose. Board Rule 295.14 A prescription dispensed under this section is considered as dispensed for a legitimate medical purpose in the usual course of professional practice. A pharmacist who, acting in good faith and with reasonable care, dispenses or does not dispense an opioid antagonist under a valid prescription is not subject to any criminal or civil liability or any professional disciplinary action for: Board Rule 295.14 dispensing or failing to dispense the opioid antagonist; or if the pharmacist chooses to dispense an opioid antagonist, any outcome resulting from the eventual administration of the opioid antagonist. Texas State Board of Pharmacy 2
Class A Pharmacy Library Requirements Effective Date: September 6, 2017 Library requirements were amended to Add a new reference if the pharmacy dispenses veterinary prescriptions, the pharmacy must have a general reference text on veterinary drugs. TSBP Emergency Kit rules for LTC Facilities 13 291.121(b) Remote pharmacy services using emergency medication kits. Definitions Emergency medication kits (EMKs) Controlled substances and dangerous drugs maintained by a provider pharmacy to meet the emergency medication needs of a resident at: An institution licensed under Chapter 242 or 252, Health and Safety Code; or An institution in Texas that is a veterans home if the provider pharmacy is a US Dept. of Veterans Affairs pharmacy or another federally operated pharmacy. Application for Registration. A pharmacy must apply to TSBP for permission to provide pharmacy services using an EMK. Upon approval of the application, the provider pharmacy will be sent a certificate which must be displayed at the remote site. 15 16 Quiz A provider pharmacy may not place an EMK in a remote site which already has a kit from another provider pharmacy except as provided by the rules. True or False General requirements. A provider pharmacy: May provide remote pharmacy services using an EMK to an institution. May provide remote pharmacy services at more than one remote site. May not place an EMK in a remote site which already has a kit from another provider pharmacy except as provided by the rules. 17 18 Texas State Board of Pharmacy 3
General requirements (cont.). If more than 1 provider pharmacy provides an EMK to a remote site, the pharmacies: Must enter into a written agreement as to the emergency medications supplied by each pharmacy May not duplicate drugs stored in the EMK. The written agreement must include reasons why an additional pharmacy is required to meet the emergency medication needs of the institution. General requirements (cont.). A provider pharmacy that is licensed as Class C or a non-resident Class E pharmacy is required to comply with the provisions of 291.31-291.34 (Class A rules). The PIC of the provider pharmacy is responsible for all pharmacy operations involving the EMK at the remote site including supervision of the EMK and compliance with the rules. 19 20 Environment/Security. EMKs must have adequate security and procedures to: prohibit unauthorized access; comply with federal and state laws and regulations; and maintain patient confidentiality. Environment/Security (cont.). Access to the EMK must be limited to RPhs and healthcare personnel employed by the facility. Drugs must be stored in compliance with Board rules regarding storage and outdated drugs. EMKs must have security and procedures to: prohibit unauthorized access; comply with federal and state laws and regulations; and maintain patient confidentiality. 21 22 Environment/Security (cont.). Drugs in the EMK may be accessed for administration to meet the emergency needs of a resident pursuant to an Rx order. The Rx order for the drugs must be forwarded to the provider pharmacy The remote site must notify the provider pharmacy of each entry into an EMK. Drugs. The contents of an EMK: May consist of dangerous drugs and controlled substances; and Shall be: determined by the consultant RPh, PIC of the provider pharmacy, medical director, and the director of nurses; and limited to drugs necessary to meet the resident's emergency medication needs (a situation in which a drug cannot be supplied within a reasonable time period). 23 24 Texas State Board of Pharmacy 4
Drugs (cont.). When choosing drugs for the EMK, the consultant RPh, PIC of the provider pharmacy, med. director, and the dir. of nurses must select the drugs for potential emergency incidents based on: Clinical criteria applicable to the facility's patients; The facility's census; and The facility's healthcare environment. Drugs (cont.). A list of the drugs stored in the remote site's EMK must be kept by the provider pharmacy and a copy kept with the EMK. An automated pharmacy system (APS) may be used as an EMK, provided the system limits access to those drugs approved for the EMK. 25 26 Drugs (cont.). Drugs for use in an EMK must be packaged in the original manufacturer's container or prepackaged in the provider pharmacy and labeled in compliance with TSBP s rules. Stocking emergency medication kits. Stocking of drugs in an EMK must be completed at: the provider pharmacy; or remote site by a RPh or a pharmacy technician under the direct supervision of a RPh. 27 28 Stocking. If the EMK is an APS that uses bar-coding or other technologies to ensure that the containers/unit dose drugs are accurately loaded, the prepackaging of the containers/unit dose drugs must occur at the provider pharmacy, unless provided by a FDA repackager. All drugs stocked in the EMK must be delivered by the provider pharmacy. Stocking. The prepackaged containers/unit dose drugs may be sent to the site to be loaded by personnel designated by the PIC provided: A RPh verifies the container/unit dose drug has been properly filled and labeled; The containers/unit dose drugs are transported in a secure, tamper-evident container; and the APS uses bar-coding or other technologies to ensure the drugs are accurately loaded in the APS. 29 30 Texas State Board of Pharmacy 5
Policies and Procedures. A provider pharmacy that provides services using an EMK must operate according to written policies and procedures. The P&P manual must include the following: Duties which may only be performed by a RPhs; A copy of the written contract or agreement between the pharmacy and the facility. date of last review/revision of the P&P. Policies and Procedures for: Security Operation of the EMK Preventative maintenance of the APS if the EMK is APS Sanitation Storage of drugs Dispensing Supervision Drug procurement Receiving of drugs Delivery of drugs Recordkeeping 31 32 Policies and Procedures (cont.). A pharmacy that provides services through an EMK shall, at least annually: Review its written P&P; Revise them if necessary; and Document the review. Policies and Procedures (cont.). A pharmacy providing services using an EMK that is an APS must have a written plan for recovery from an event which interrupts the ability of the APS to provide medications. The plan must include: Planning and preparation for maintaining pharmacy services when an APS experiences downtime; 33 34 Policies and Procedures (cont.). The written plan for recovery must include: Procedures for response for downtime; and Procedures for the maintenance and testing of the plan for recovery. Maintenance of records. Every required record must be: Kept by the provider pharmacy and be available, for at least 2-years for inspecting and copying by TSBP or its representative and to other authorized local, state, or federal law enforcement agencies; and Supplied by the provider pharmacy within 72-hours, if requested by an authorized agent of the TSBP. Maintained as specified in Class A Rules. 35 36 Texas State Board of Pharmacy 6
Transaction information. A Rx must be maintained by the provider pharmacy as the record of removal of a drug from an EMK for administration to a patient. The remote site must notify the provider pharmacy of each entry into an EMK. The notification may be on the Rx or a separate document and must include the: Name, strength, and quantity of the drug and the time of removal; and Name of the person removing the drug. Transaction information (cont.) A separate record of stocking, removal, or dispensing from an EMK must kept and include the: Date Name, strength, dosage form, and quantity of drug Name, initials, or ID code of the person stocking, removing, or dispensing, drugs from the system Name, initials, or identification code of the pharmacist who checks and verifies that the system has been accurately filled Unique Rx number assigned to the Rx when the drug is administered to the patient 37 38 Inventory. A provider pharmacy must keep a: Record of all drugs sent to and returned from a remote site separate from the records of the provider pharmacy and other remote site's records; and Keep a perpetual inventory of all controlled substances that are received and dispensed or distributed from each remote site. Inventory (cont.) A provider pharmacy must conduct an inventory at each remote site. The inventory of each remote site and the provider pharmacy must be taken on the same day and must be included with, but listed separately from, the drugs of other remote sites and separately from the drugs at the provider pharmacy. 39 40 Pharmacy Related Legislation Passed by the 2017 Texas Legislature The Sunset Bill (HB 2561) Effective Date: 9/1/2017 Texas State Board of Pharmacy 7
Thompson/Sen. Van Taylor Effective Date: 9/1/2017 Amends the Pharmacy Act to: Continue TSBP until 8/31/2029; Remove the requirement that a person be of good moral character to obtain a license or registration; Amends the Pharmacy Act to: Allow the Board to refuse to renew a license to practice pharmacy for a license holder who is in violation of a Board order; Specifies that TSBP must adopt rules relating to the CE required for pharmacy technicians. Amends the Pharmacy Act to specify that pharmacy technician CE requirements must include the: Number of hours of CE; Methods for meeting the CE requirements; Approval of CE programs; Reporting completion of CE; Records of completion of CE; and Board audits to ensure compliance. Amends the Pharmacy Act to specify that to renew a pharmacy technician registration, the registrant must, before the expiration date of the registration: Pay the renewal fee; and Comply with the continuing education requirements. Amends the Pharmacy Act to specify that to renew a pharmacy technician registration after a registration has been expired for: 90 days or <, the technician must pay a renewal fee that is equal to 1½ times the renewal fee; > than 90 days, but < 1 year, the technician must pay a renewal fee that is 2 times the renewal fee; 1 year or >, the technician may not renew. Adds a new section 551.006 to the Pharmacy Act titled Exclusive Authority that specifies that a pharmacist has the exclusive authority to determine whether or not to dispense a drug. Texas State Board of Pharmacy 8
Adds a new section 551.008 to the Pharmacy Act titled: Prohibition on Rule Violating Sincerely Held Religious Belief that specifies: All rules or policies adopted by TSBP may not violate the Religious Freedom provisions of the Texas Civil Practice and Remedies Code; and A person may assert a violation of the religious freedom provisions as an affirmative defense in an administrative hearing or as a claim or defense in a judicial proceeding. Specifies that Board must adopt rules regarding the use of a telepharmacy system including the locations eligible to be licensed as remote dispensing sites, which must include: Locations in medically underserved areas; Areas with a medically underserved population; and Health professional shortage areas. The Board must adopt rules specifying licensing and operating requirements, including a requirement that a: Remote dispensing site license identify the provider pharmacy that will provide pharmacy services at the remote dispensing site; Provider pharmacy be allowed to provide phcy services at no more than 2 remote sites; The Board must adopt rules that require: A RPh employed by a provider phcy make at least monthly on-site visits to a remote dispensing site or more frequent visits if specified by Board rule; The perpetual inventory of controlled substances at the remote site be reconciled monthly by a RPh employed by the provider pharmacy; The Board must adopt rules that require: A RPh employed by a provider pharmacy be physically present when providing services requiring the physical presence of the pharmacist, including immunizations; A remote site be staffed by an on-site pharmacy tech under the continuous supervision of a RPh; Texas State Board of Pharmacy 9
The Board must adopt rules that require: All pharmacy technicians at a remote site be counted when establishing the pharmacist/pharmacy technician ratio of the provider phcy, which, may not exceed 3 pharmacy technicians for each pharmacist; The Board must adopt rules that require: Before working at a remote site, a pharmacy technician must have: Worked at least 1-year at a retail phcy during the 3-years preceding the date the pharmacy tech begins working at the remote site; and Have completed a Board-approved training program on the proper use of a telepharmacy system; The Board must adopt rules that specify that: A pharmacy tech may not perform extemporaneous sterile or nonsterile compounding but may prepare commercially available meds for dispensing, including the reconstitution of powder antibiotics; and Any additional training or practice experience for pharmacy techs at a remote site. The bill specifies that a telepharmacy system at a remote dispensing site may not: Dispense CII controlled substances. Be located within 22 miles, by road, of a Class A pharmacy. Except if a Class A pharmacy is established within 22 miles of a remote dispensing site that is currently operating, the remote dispensing site may continue to operate at that location. The Act specified that the Board by rule shall require and develop a process for a remote site to apply for a Class A phcy license IF the average number of Rxs dispensed each day the remote dispensing site is open for business is more than 125, as calculated each calendar year. Quiz Effective 9-1-2017, wholesalers are required to submit the sale of controlled substances to the Texas State Board of Pharmacy. True or False Texas State Board of Pharmacy 10
Quiz The bill adds a new Sec. 481.0764 to the Texas Controlled Substances Act (TCSA) titled Reports of Wholesale Distributors to require wholesalers to report to TSBP the sale of a controlled substance made by the distributor to a person in this state. HB2561 amend the Texas Controlled Substances Act to require pharmacies to send all required information for Schedule II V prescriptions to the Prescription Monitoring Program no later than the next business day after the date the prescription is completely filled. True or False Thompson/Sen. Van Taylor The bill amends the TCSA to require pharmacies to send all required information for Schedule II V prescriptions to the PMP not later than the next business day after the date the prescription is completely filled. The bill amends the TCSA to require each regulatory agency that issues a license, to a prescriber to promulgate specific guidelines for prescribers regulated by that agency for the responsible prescribing of opioids, benzodiazepines, barbiturates, or carisoprodol. Quiz Effective 9-1-2019, pharmacists will be required to access the PMP before dispensing Opioids; Benzodiazepines; Barbiturates; or Carisoprodol. True or False The bill amends the TCSA to specify that after 9/1/2019, a pharmacist or prescriber authorized access the PMP, other than a veterinarian, shall access the PMP for the patient before prescribing or dispensing: Opioids; Benzodiazepines; Barbiturates; or Carisoprodol. Texas State Board of Pharmacy 11
Controlled Substance Dispensed Data from the PMP- FY2017 % of the 4 Controlled Substances Dispensed % of ALL Controlled Substances Dispensed # Rxs Dispensed Barbiturates 192,974 <1% <1% Benzodiazepines 8,308,209 31% 21% Carisoprodol 528,543 2% 1% Opioids 17,984,222 66% 45% Total of Above Controlled Substances Dispensed Total of Other Controlled Substance Dispensed Grand Total of All Controlled Substance Dispensed 39,419,516 27,013,858 68% 12,405,658 32% BARBITURATES, BENZODIAZEPINES, CARSIPRODOL AND OPIOIDS REPRESENT 68% OF ALL CONTROLLED SUBSTANCES DISPENSED DURING THIS PERIOD The bill amends the TCSA to specify that a: A dispenser or prescriber may access information of a patient before dispensing or prescribing any controlled substance; and A veterinarian may access the info for Rxs dispensed only for the animals of an owner and may not consider the personal Rx history of the owner. The bill amends the TCSA to specify that if a prescriber or dispenser violates the law related to the access of the PMP, this action is grounds for disciplinary action by the regulatory agency that issued a license to the person who committed the violation. The bill amends the Health and Safety Code to add a new Chapter 442 titled Donation Of Prescription Drugs. The new chapter specifies requirements for an individual to donate unused Rx drugs (dangerous drugs only) to a participating provider (health-care facility or pharmacy). Texas State Board of Pharmacy 12
The bill amends the education code to specify that: Other Pharmacy Related Bills Passed by the Texas Legislature The college shall be known as the Texas A&M University System Health Science Center Irma Lerma Rangel College of Pharmacy, and the primary building in which the school is operated shall be located in Kleberg County and must include "Irma Rangel" in its official name. HB 1178 by Rep. Kuempel/Sen. Hinojosa Effective Date: 9/1/2017. Increases the penalty for stealing a controlled substance to a felony if the: Building in which a controlled substance is stored is a pharmacy, clinic, hospital, or nursing facility; and Person entered or remained concealed in that building with intent to commit a theft of a controlled substance. HB 1178 by Rep. Kuempel/Sen. Hinojosa (cont.) Amends the penal code to specify that an offense is a state jail felony if a controlled substance is taken, regardless of the value of the controlled substance stolen. PMP AWARxE Texas Prescription Monitoring Program Go to the PMP Website: texas.pmpaware.net OR Go to the TSBP Website: www.pharmacy.texas.gov Texas State Board of Pharmacy 13
User with existing accounts were transferred to the new system. Login using email and reset password. New users can create an account. Texas State Board of Pharmacy 14
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PRESCRIPTION MONITORING PROGRAM FY2017 Quarterly Reports 1 st Quarter 2 nd Quarter 3 rd Quarter 4 th Quarter Year-to- Date Registered Users 43,227 5,494 4,773 5,148 58,642 Searches 800,041 982,602 1,113,526 1,279,436 4,175,605 Prescriptions Dispensed 10,123,585 10,092,111 9,856,895 9,346,925 39,419,516 Still valid prescription forms! Texas Prescription Monitoring Program Facebook Page www.facebook.com/texaspmp/ The Texas PMP Facebook page will offer news and updates specific to the program. Thank You! Texas State Board of Pharmacy 16