texas pharmacy law update speaker disclosure · –remote site by a rph or a pharmacy technician...

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


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


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



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


19



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



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



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



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



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



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


25



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



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



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



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



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



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


31



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



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



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




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




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



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


37



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



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



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



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


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;


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.



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.




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.




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.

January 27, 2018




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;




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





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;




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

January 27, 2018




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


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.

January 27, 2018


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



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).

January 27, 2018




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

http://www.pharmacy.texas.gov/

January 27, 2018


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


January 27, 2018


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!

texas pharmacy law update speaker disclosure · –remote site by a rph or a pharmacy technician...

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