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January 27, 2018
Texas State Board of Pharmacy 1
Allison Vordenbaumen Benz, R.Ph., M.S.
Executive Director/Secretary
Texas Chapter of the
American Society of Consultant Pharmacists
January 27, 2018
Texas Pharmacy Law Update Speaker Disclosure
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 MembersJeanne 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
5
Recently Adopted Rules
January 27, 2018
Texas State Board of Pharmacy 2
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 opioid-
related 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.
January 27, 2018
Texas State Board of Pharmacy 3
13
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
15
§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.
16
Remote pharmacy services using
emergency medication kits (cont.)
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.
17
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
18
Remote pharmacy services using
emergency medication kits (cont.)
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.
January 27, 2018
Texas State Board of Pharmacy 4
19
Remote pharmacy services using
emergency medication kits (cont.)
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.
20
Remote pharmacy services using
emergency medication kits (cont.)
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.
21
Remote pharmacy services using
emergency medication kits (cont.)
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.
22
Remote pharmacy services using
emergency medication kits (cont.)
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.
23
Remote pharmacy services using
emergency medication kits (cont.)
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.
24
Remote pharmacy services using
emergency medication kits (cont.)
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).
January 27, 2018
Texas State Board of Pharmacy 5
25
Remote pharmacy services using
emergency medication kits (cont.)
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.
26
Remote pharmacy services using
emergency medication kits (cont.)
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.
27
Remote pharmacy services using
emergency medication kits (cont.)
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.
28
Remote pharmacy services using
emergency medication kits (cont.)
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.
29
Remote pharmacy services using
emergency medication kits (cont.)
Stocking emergency medication kits (cont.).
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.
30
Remote pharmacy services using
emergency medication kits (cont.)
Stocking emergency medication kits (cont.).
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.
–
January 27, 2018
Texas State Board of Pharmacy 6
31
Remote pharmacy services using
emergency medication kits (cont.)
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.
32
Remote pharmacy services using
emergency medication kits (cont.)
Policies and Procedures for:
Security Supervision
Operation of the EMK Drug procurement
Preventative maintenance of the APS
if the EMK is APS
Receiving of drugs
Sanitation Delivery of drugs
Storage of drugs Recordkeeping
Dispensing
33
Remote pharmacy services using
emergency medication kits (cont.)
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.
34
Remote pharmacy services using
emergency medication kits (cont.)
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;
35
Remote pharmacy services using
emergency medication kits (cont.)
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.
36
Remote pharmacy services using
emergency medication kits (cont.)
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.
January 27, 2018
Texas State Board of Pharmacy 7
37
Remote pharmacy services using
emergency medication kits (cont.)
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.
38
Remote pharmacy services using
emergency medication kits (cont.)
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
39
Remote pharmacy services using
emergency medication kits (cont.)
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.
40
Remote pharmacy services using
emergency medication kits (cont.)
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.
Pharmacy Related Legislation
Passed by the
2017 Texas LegislatureThe “Sunset” Bill (HB 2561)
Effective Date: 9/1/2017
January 27, 2018
Texas State Board of Pharmacy 8
HB 2561 by Rep. Senfronia
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;
HB 2561 by Rep. Senfronia
Thompson/Sen. Van Taylor (cont.)
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.
HB 2561 by Rep. Senfronia
Thompson/Sen. Van Taylor (cont.)
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.
HB 2561 by Rep. Senfronia
Thompson/Sen. Van Taylor (cont.)
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.
HB 2561 by Rep. Senfronia
Thompson/Sen. Van Taylor (cont.)
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.
HB 2561 by Rep. Senfronia
Thompson/Sen. Van Taylor (cont.)
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.
January 27, 2018
Texas State Board of Pharmacy 9
HB 2561 by Rep. Senfronia
Thompson/Sen. Van Taylor (cont.)
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
HB 2561 by Rep. Senfronia
Thompson/Sen. Van Taylor (cont.)
– 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.
HB 2561 by Rep. Senfronia
Thompson/Sen. Van Taylor (cont.)
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.
HB 2561 by Rep. Senfronia
Thompson/Sen. Van Taylor (cont.)
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;
HB 2561 by Rep. Senfronia
Thompson/Sen. Van Taylor (cont.)
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;
HB 2561 by Rep. Senfronia
Thompson/Sen. Van Taylor (cont.)
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;
January 27, 2018
Texas State Board of Pharmacy 10
HB 2561 by Rep. Senfronia
Thompson/Sen. Van Taylor (cont.)
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;
HB 2561 by Rep. Senfronia
Thompson/Sen. Van Taylor (cont.)
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;
HB 2561 by Rep. Senfronia
Thompson/Sen. Van Taylor (cont.)
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.
HB 2561 by Rep. Senfronia
Thompson/Sen. Van Taylor (cont.)
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.
HB 2561 by Rep. Senfronia
Thompson/Sen. Van Taylor (cont.)
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
January 27, 2018
Texas State Board of Pharmacy 11
HB 2561 by Rep. Senfronia
Thompson/Sen. Van Taylor (cont.)
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.
Quiz
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
HB 2561 by Rep. Senfronia
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.
HB 2561 by Rep. Senfronia
Thompson/Sen. Van Taylor (cont.)
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
HB 2561 by Rep. Senfronia
Thompson/Sen. Van Taylor (cont.)
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.
January 27, 2018
Texas State Board of Pharmacy 12
Data from the PMP- FY2017
Controlled Substance
Dispensed
# Rxs
Dispensed
% of the 4
Controlled
Substances
Dispensed
% of ALL
Controlled
Substances
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 Dispensed27,013,858 68%
Total of Other Controlled
Substance Dispensed12,405,658 32%
Grand Total of All Controlled
Substance Dispensed39,419,516
BARBITURATES, BENZODIAZEPINES, CARSIPRODOL AND OPIOIDS
REPRESENT 68% OF ALL CONTROLLED SUBSTANCES DISPENSED
DURING THIS PERIOD
HB 2561 by Rep. Senfronia
Thompson/Sen. Van Taylor (cont.)
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.
HB 2561 by Rep. Senfronia
Thompson/Sen. Van Taylor (cont.)
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.
HB 2561 by Rep. Senfronia
Thompson/Sen. Van Taylor (cont.)
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).
January 27, 2018
Texas State Board of Pharmacy 13
HB 2561 by Rep. Senfronia
Thompson/Sen. Van Taylor (cont.)
The bill amends the
education code to specify
that:
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.
Other Pharmacy Related Bills
Passed by the Texas Legislature
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.
Texas Prescription
Monitoring Program
PMP AWARxE
Go to the PMP Website:
texas.pmpaware.net
OR
Go to the TSBP Website:
www.pharmacy.texas.gov
January 27, 2018
Texas State Board of Pharmacy 14
User with existing accounts were
transferred to the new system.
Login using email and reset
password. New users can create an
account.
January 27, 2018
Texas State Board of Pharmacy 15
January 27, 2018
Texas State Board of Pharmacy 16
PRESCRIPTION MONITORING PROGRAM
FY2017 Quarterly Reports
1st Quarter 2nd Quarter 3rd Quarter 4th QuarterYear-to-
Date
Registered
Users43,227 5,494 4,773 5,148 58,642
Searches 800,041 982,602 1,113,526 1,279,436 4,175,605
Prescriptions
Dispensed10,123,585 10,092,111 9,856,895 9,346,925 39,419,516
Still valid prescription forms!
www.facebook.com/TexasPMP/
The Texas PMP Facebook page will offer news and updates
specific to the program.
Texas Prescription Monitoring Program
Facebook Page
Thank You!