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Texas State Profile
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EC PHARMACY UPDATE
NARAL Pro-Choice Texas plans to visit pharmacies throughout the state to educate pharmacists about EC and find out if EC is stocked.
EC pharmacy access bills were introduced in February 2005. SB 477 (HB 1637) from Senator Jeff Wentworth (R) and Representative Senfronia Thompson (D) require that pharmacists obtain EC training and establish a collaborative practice agreement with a physician before providing EC directly to women. The pharmacist would be required to inform the authorizing physician about each EC provision. HB 1354 from Representative Michael Villarreal (D) addresses pharmacist-physician collaborative agreements along with grants for teen pregnancy prevention programs, contraceptive coverage, and EC information. HB 1658 from Representative Jessica Farrar (D) deals with pharmacy access to EC as well as human sexuality education and EC for sexual assault victims.
Pharmacy access legislation (HB 1381/SB 1339) was introduced in 2003. Texas pharmacists got involved after several women’s advocacy groups brought forward an EC initiative. A broad coalition (PDF-16K) of organizations including the Texas Pharmacy Association supported this legislation. There was significant interest in this effort, and the Texas legislature invited pharmacists to testify on the bill. Both the House and Senate had committee hearings.
Both the Austin American-Statesman (April 21, 2003) (PDF-2.4MB) and the Houston Chronicle (March 6, 2003) (PDF-2MB), two of Texas’s biggest daily papers, ran editorials in support of passage of HB 1381. In the end, the bill died in Committee. The EC legislation cannot be re-introduced until 2005.
The Texas House Committee on Judicial Affairs, in its Interim Report to the 78th Texas Legislature in December 2002 (PDF-364K), recommended: “(Recommendation 7) Emergency contraception should be available behind-the-counter in pharmacies on request. The pharmacy should be able to require the requestor to fill out a simple form that might reveal contraindications for emergency contraceptives. Pharmacists who dispense emergency contraception without a prescription should be required to obtain certification through a continuing education class. Pharmacists should be required to enter into a protocol with a licensed medical doctor before dispensing emergency contraception.”
58% of Texans surveyed support making emergency contraception widely available to Texas women according to a 2001 Scripps Howard Data Center Texas poll (PDF-44K).
An Eckerd pharmacist’s refusal to fill a prescription for EC because of moral issues drew media attention and highlighted the controversy over pharmacists as conscientious objectors. The pharmacist was later disciplined by Eckerd Pharmacy. Texas Pharmacy Association has an established policy statement stating the following: “TPA recognizes that a pharmacist has a responsibility in the care of patients. TPA supports prior notification by a pharmacist to the pharmacist’s immediate supervisor where conscientious objection may occur so that a system may be developed to ensure that patients have access to legally prescribed therapy and/or pharmaceutical care without compromising the pharmacists’ right to a conscientious refusal.”
For press coverage in this state, click here.
CONTACTS
Jim Martin, R.Ph.
CEO
Texas Pharmacy Association
P.O. Box 14709
Austin, TX 78761-4709
(512) 836-8350
Fax (512) 836-0308
jmartin@texaspharmacy.org
www.texaspharmacy.org
Kim Roberson, R.Ph.
Sr. Director of Professional Affairs
Texas Pharmacy Association
P.O. Box 14709
Austin, TX 78761-4706
512-836-8350
Fax: 512-836-0308
Kroberson@txpharmacy.com
Sarah Wheat
Director of Public Affairs
NARAL Pro-Choice Texas
PO Box 684602
Austin, TX 78768
512-462-1661
sarah@taral.org
Herb Brown, MD
OB-GYN
Private (Board member, Physicians for Reproductive Choice & Health - PRCH), Affiliated with UT Medical School
7 Bromich Court
San Antonio, TX 78218
hp-srb@swbell.net
USEFUL LINKS
Texas State Board of Pharmacy
www.tsbp.state.tx.us/default.htm
Texas Pharmacy Association
www.txpharmacy.com
Texas Legislature
www.capitol.state.tx.us
Planned Parenthood of Amarillo and the Texas Panhandle
www.ppatp.org
Planned Parenthood of the Texas Capital Region
www.ppaustin.org
Planned Parenthood of South Texas
www.ppstx.org
Planned Parenthood of North Texas
www.ppnt.org
Planned Parenthood of Houston and Southeast Texas
www.pphouston.org/site/PageServer
Planned Parenthood of West Texas, Inc.
www.ppwesttexas.org
Planned Parenthood of Central Texas
www.charityadvantage.com/plannedparenthoodwaco/Home.asp
Planned Parenthood of San Antonio and South Central Texas
www.ppsctx.org
NARAL Pro-Choice Texas
www.taral.org
EC Resources in Austin, TX
www.morningafterpillaustin.com
PROTOCOL ENVIRONMENT
Possible Environment: Revision to Existing Authority Required
This state permits collaborative practice agreements or a similar agreement between physicians and pharmacists. However, some modification of existing statutes and/or regulations is required to allow pharmacists to initiate EC for the general community.
Pharmacist initiation of EC would require:
- Modifying the requirement that protocols are only valid for existing patients of the authorizing prescriber.
PHARMACY PRACTICE ACT
Pharmacy Practice Act Regulatory and Statutory Authority
Note: The text presented below has been prepared by the American Pharmacists Association for the Pharmacy Access Partnership and reflects legislation or regulation promulgated as of June 15, 2003.
TEXAS
Pharmacists practicing in any setting may implement collaborative practice, although the agreements are valid only for existing patients of the authorizing prescriber. Participating pharmacists must have completed six hours of Board-approved continuing education relating to drug therapy initially, and then annually. Protocols are valid for one year and can be patient-specific, standard or standard with notation of patient-specific deviation, if any, from the standard protocol. Patient-specific or standard protocols must be maintained with the pharmacist and interventions documented in the patient medication record, medical chart or in a separate log within a reasonable time frame. Protocols must also be reviewed at least annually.
These protocol requirements do not restrict the use of a pre-established health care program or restrict a physician from authorizing the provision of patient care from such a program if the care is to be given in a hospital with an organized medical staff that has authorized standing delegation orders, standing medical orders or protocols.
The scope of practice is outlined within the written protocol and may include:
- implementing or modifying drug therapy following diagnosis
- ordering or performing routine drug therapy-related patient assessment procedures including temperature, pulse, and respiration
- ordering drug therapy related laboratory tests
- initial patient assessment, and ordering of drug therapy by a physician as detailed in the protocol or
- any other drug therapy related act delegated by physician.
Protocols must also contain statements relating to physician-pharmacist communication and update. Records are to be kept with the pharmacist.
Statutory authority: Provided in the Medical Practice Act (definition for written protocol) Tex. Occ. Code Ann. §157 and the Pharmacy Practice Act §551 (definitions of administer, pharmaceutical care, practice of pharmacy and written protocol.)
- Regulatory authority: Provided in dedicated sections on drug therapy management
- 22 Tex. Admin. Code §295.13 and §295.15
TEXAS STATUTE
CHAPTER 157. AUTHORITY OF PHYSICIAN TO DELEGATE CERTAIN MEDICAL ACTS
SUBCHAPTER A. GENERAL PROVISIONS
§ 157.001. General Authority of Physician to Delegate
(a) A physician may delegate to a qualified and properly trained person acting under the physician's supervision any medical act that a reasonable and prudent physician would find within the scope of sound medical judgment to delegate if, in the opinion of the delegating physician:
- (1) the act:
- (A) can be properly and safely performed by the person to whom the medical act is delegated;
- (B) is performed in its customary manner; and
- (C) is not in violation of any other statute; and
- (2) the person to whom the delegation is made does not represent to the public that the person is authorized to practice medicine.
(b) The delegating physician remains responsible for the medical acts of the person performing the delegated medical acts.
(c) The board may determine whether:
- (1) an act constitutes the practice of medicine, not inconsistent with this chapter; and
- (2) a medical act may be properly or safely delegated by physicians.
Acts 1999, 76th Leg., ch. 388, § 1, eff. Sept. 1, 1999.
SUBCHAPTER C. DELEGATION TO PHARMACISTS
§ 157.101. Delegation to Pharmacist
(a) In this section, “pharmacist” has the meaning assigned by Section 551.003.
(b) A physician may delegate to a properly qualified and trained pharmacist acting under adequate physician supervision the performance of specific acts of drug therapy management authorized by the physician through the physician's order, standing medical order, standing delegation order, or other order or protocol as defined by board rule.
(c) Physician supervision is considered to be adequate for the purposes of this section if a delegating physician:
- (1) is responsible for the formulation or approval of the physician's order, standing medical order, standing delegation order, or other order or protocol and periodically reviews the order or protocol and the services provided to a patient under the order or protocol;
- (2) has established a physician-patient relationship with each patient who is provided drug therapy management by a delegated pharmacist;
- (3) is geographically located so as to be able to be physically present daily to provide medical care and supervision;
- (4) receives, as appropriate, a periodic status report on each patient, including any problem or complication encountered; and
- (5) is available through direct telecommunication for consultation, assistance, and direction.
(d) This section does not restrict the use of a preestablished health care program or restrict a physician from authorizing the provision of patient care by use of a preestablished health care program if the patient is institutionalized and the care is to be delivered in a licensed hospital with an organized medical staff that has authorized standing delegation orders, standing medical orders, or protocols.
(e) This section does not limit, expand, or change any provision of law relating to therapeutic drug substitution or administration of medication, including Section 554.004.
(f) The board by rule shall establish the minimum content of a written order or protocol. The order or protocol may not permit the delegation of medical diagnosis.
SUBTITLE J. PHARMACY AND PHARMACISTS
CHAPTER 551. GENERAL PROVISIONS
§ 551.001. Short Title
The chapters of this subtitle, other than Chapter 567, may be cited as the Texas Pharmacy Act.
Acts 1999, 76th Leg., ch. 388, § 1, eff. Sept. 1, 1999.
§ 551.003. Definitions
In Chapters 551-566:
(1) “Administer” means to directly apply a prescription drug to the body of a patient by any means, including injection, inhalation, or ingestion, by:
- (A) a person authorized by law to administer the drug, including a practitioner or an authorized agent under a practitioner's supervision; or
- (B) the patient at the direction of a practitioner.
…
(10) “Confidential record” means a health-related record, including a patient medication record, prescription drug order, or medication order, that:
- (A) contains information that identifies an individual; and
- (B) is maintained by a pharmacy or pharmacist.
…
(14) “Designated agent” means:
- (A) an individual, including a licensed nurse, physician assistant, or pharmacist:
- (i) who is designated by a practitioner and authorized to communicate a prescription drug order to a pharmacist; and
- (ii) for whom the practitioner assumes legal responsibility;
- (B) a licensed nurse, physician assistant, or pharmacist employed in a health care facility to whom a practitioner communicates a prescription drug order; or
- (C) a registered nurse or physician assistant authorized by a practitioner to administer a prescription drug order for a dangerous drug under Subchapter B, Chapter 157.
…
(19) “Drug regimen review” includes evaluation of prescription drug or medication orders and a patient medication record for:
- (A) a known allergy;
- (B) a rational therapy-contraindication;
- (C) a reasonable dose and route of administration;
- (D) reasonable directions for use;
- (E) duplication of therapy;
- (F) a drug-drug interaction;
- (G) drug-food interaction;
- (H) drug-disease interaction;
- (I) adverse drug reaction; and
- (J) proper use, including overuse or underuse.
…
(24) “Medication order” means an order from a practitioner or a practitioner's designated agent for administration of a drug or device.
…
(27) “Pharmaceutical care” means providing drug therapy and other pharmaceutical services defined by board rule and intended to assist in curing or preventing a disease, eliminating or reducing a patient's symptom, or arresting or slowing a disease process.
(33) “Practice of pharmacy” means:
- (A) providing an act or service necessary to provide pharmaceutical care;
- (B) interpreting or evaluating a prescription drug order or medication order;
- (C) participating in drug or device selection as authorized by law, and participating in drug administration, drug regimen review, or drug or drug-related research;
- (D) providing patient counseling;
- (E) being responsible for:
- (i) dispensing a prescription drug order or distributing a medication order;
- (ii) compounding or labeling a drug or device, other than labeling by a manufacturer, repackager, or distributor of a nonprescription drug or commercially packaged prescription drug or device;
- (iii) properly and safely storing a drug or device; or
- (iv) maintaining proper records for a drug or device;
- (F) performing for a patient a specific act of drug therapy management delegated to a pharmacist by a written protocol from a physician licensed in this state in compliance with Subtitle B; or
- (G) administering an immunization or vaccination under a physician's written protocol.
. . .
(45) “Written protocol” means a physician's order, standing medical order, standing delegation order, or other order or protocol as defined by rule of the Texas State Board of Medical Examiners under Subtitle B.
TEXAS REGULATIONS
TITLE 22 EXAMINING BOARDS
PART 9 TEXAS STATE BOARD OF MEDICAL EXAMINERS
CHAPTER 193 STANDING DELEGATION ORDERS
RULE §193.7 Delegated Drug Therapy Management
(a) Purpose. This section is promulgated to promote the efficient administration and regulation of the delegation by physicians to pharmacists of drug therapy management pursuant to the Medical Practice Act, Texas Occupations Code Annotated, §157.001 (related to Delegation of Certain Functions).
(b) Delegation. A physician licensed to practice medicine in Texas may delegate to a properly qualified and trained pharmacist acting under adequate supervision the performance of specific acts of drug therapy management authorized by the physician through the physician's order, standing medical order, standing delegation order, or other order or protocol as provided for in this section.
(c) Drug therapy management. Drug therapy management is the performance of specific acts by pharmacists as authorized by a physician through written protocol. Drug therapy management does not include the selection of drug products not prescribed by the physician unless the drug product is named in the physician initiated protocol or the physician initiated record of deviation from a standing protocol. Drug therapy management may include the following listed in paragraphs (1)-(6) of this subsection:
- (1) collecting and reviewing patient drug use histories;
- (2) ordering or performing routine drug therapy related patient assessment procedures including temperature, pulse, and respiration;
- (3) ordering drug therapy related laboratory tests;
- (4) implementing or modifying drug therapy following diagnosis, initial patient assessment, and ordering of drug therapy by a physician, as detailed in the protocol;
- (5) generically equivalent drug selection if the physician's signature does not clearly indicate that the prescription must be dispensed as written; or
-
- (6) any other drug therapy related act delegated by a physician.
(d) Supervision. Physician supervision shall be considered adequate for purposes of this section if the delegating physician is in compliance with this section and the physician:
- (1) is responsible for the formulation or approval of the written protocol and any patient-specific deviation from the protocol and review of the written protocol and any patient-specific deviations from the protocol at least annually and the services provided to a patient under the protocol on a schedule defined in the written protocol;
- (2) has established and maintains a physician-patient relationship with each patient provided drug therapy management by a delegated pharmacist and informed the patient that drug therapy will be managed by a pharmacist under written protocol;
- (3) is geographically located so as to be able to be physically present daily to provide medical care and supervision;
- (4) receives, on a schedule defined in the written protocol, a periodic status report on the patient, including any problem or complication encountered;
- (5) is available through direct telecommunication for consultation, assistance, and direction.
(e) Written protocol. Written protocols for purposes of this section shall mean a physician's order, standing medical order, standing delegation order, or other written order.
- (1) A written protocol must contain at a minimum the following listed in subparagraphs (A)-(E) of this paragraph:
- (A) a statement identifying the individual physician authorized to prescribe drugs and responsible for the delegation of drug therapy management;
- (B) a statement identifying the individual pharmacist authorized to dispense drugs and to engage in drug therapy management as delegated by the physician;
- (C) a statement identifying the types of drug therapy management decisions that the pharmacist is authorized to make which shall include:
- (i) a statement of the ailments or diseases, drugs, and type of drug therapy management authorized; and
- (ii) a specific statement of the procedures, decision criteria, or plan the pharmacist shall follow when exercising drug therapy management authority;
- (D) a statement of the activities the pharmacist shall follow in the course of exercising drug therapy management authority, including the method for documenting decisions made and a plan for communication or feedback to the authorizing physician concerning specific decisions made. Documentation shall be recorded within a reasonable time of each intervention and may be performed on the patient medication record, patient medical chart, or in a separate log book; and
- (E) a statement that describes appropriate mechanisms and time schedule for the pharmacist to report to the physician monitoring the pharmacist's exercise of delegated drug therapy management and the results of the drug therapy management.
- (2) A standard protocol may be used, or the attending physician may develop a drug therapy management protocol for the individual patient. If a standard protocol is used, the physician shall record, what deviations if any, from the standard protocol are ordered for that patient.
(f) Review and revision of protocols.
- (1) At least annually, written protocols shall be reviewed by the physician and, if necessary, revised.
- (2) Documentation of all services provided to the patient by the pharmacist shall be reviewed by the physician on the schedule established in the protocol.
(g) Construction and interpretation. This section shall not be construed or interpreted to restrict the use of a pre-established health care program or restrict a physician from authorizing the provision of patient care by use of a pre-established health care program if the patient is institutionalized and the care is to be delivered in a licensed hospital with an organized medical staff that has authorized standing delegation orders, standing medical orders, or protocols. This section may not be construed to limit, expand, or change any provision of law concerning or relating to therapeutic drug substitution or administration of medication, including the Texas Pharmacy Act, Article 4542a-1, Vernon's Texas Civil Statutes, §17(a)(5).
PART 15 TEXAS STATE BOARD OF PHARMACY
CHAPTER 295 PHARMACISTS
§295.13 Drug Therapy Management by a Pharmacist under Written Protocol of a Physician
a) Purpose. The purpose of this section is to provide standards for the maintenance of records of a pharmacist engaged in the provision of drug therapy management as authorized in Chapter 157 of the Medical Practice Act and §554.005 of the Act.
(b) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise.
- (1) Act--The Texas Pharmacy Act, Chapter 551 - 566, Occupations Code, as amended.
- (2) Board--The Texas State Board of Pharmacy.
- (3) Confidential record--Any health-related record maintained by a pharmacy or pharmacist, such as a patient medication record, prescription drug order, or medication order.
- (4) Drug therapy management--The performance of specific acts by pharmacists as authorized by a physician through written protocol. Drug therapy management does not include the selection of drug products not prescribed by the physician, unless the drug product is named in the physician initiated protocol or the physician initiated record of deviation from a standing protocol. Drug therapy management may include the following:
- (A) collecting and reviewing patient drug use histories;
- (B) ordering or performing routine drug therapy related patient assessment procedures including temperature, pulse, and respiration;
- (C) ordering drug therapy related laboratory tests;
- (D) implementing or modifying drug therapy following diagnosis, initial patient assessment, and ordering of drug therapy by a physician as detailed in the protocol; or
- (E) any other drug therapy related act delegated by a physician.
- (5) Medical Practice Act--The Texas Medical Practice Act, Subtitle B, Occupations Code, as amended.
- (6) Written protocol--A physician's order, standing medical order, standing delegation order, or other order or protocol as defined by rule of the Texas State Board of Medical Examiners under the Medical Practice Act.
- (A) A written protocol must contain at a minimum the following:
- (i) a statement identifying the individual physician authorized to prescribe drugs and responsible for the delegation of drug therapy management;
- (ii) a statement identifying the individual pharmacist authorized to dispense drugs and to engage in drug therapy management as delegated by the physician;
- (iii) a statement identifying the types of drug therapy management decisions that the pharmacist is authorized to make which shall include:
- (I) a statement of the ailments or diseases involved, drugs, and types of drug therapy management authorized; and
- (II) a specific statement of the procedures, decision criteria, or plan the pharmacist shall follow when exercising drug therapy management authority;
- (iv) a statement of the activities the pharmacist shall follow in the course of exercising drug therapy management authority, including the method for documenting decisions made and a plan for communication or feedback to the authorizing physician concerning specific decisions made. Documentation shall be recorded within a reasonable time of each intervention and may be performed on the patient medication record, patient medical chart, or in a separate log book; and
- (v) a statement that describes appropriate mechanisms and time schedule for the pharmacist to report to the physician monitoring the pharmacist's exercise of delegated drug therapy management and the results of the drug therapy management.
- (B) A standard protocol may be used or the attending physician may develop a drug therapy management protocol for the individual patient. If a standard protocol is used, the physician shall record what deviations, if any, from the standard protocol are ordered for that patient.
(c) Notification.
- (1) Initial notification. Prior to initially engaging in drug therapy management, a pharmacist shall provide the board with:
- (A) the name, license number, and address of the supervising physician;
- (B) the address where the records of such drug therapy management are maintained; and
- (C) a statement attesting to the fact that the pharmacist has within the last year:
- (i) completed at least six hours of continuing education related to drug therapy offered by a provider approved by the American Council on Pharmaceutical Education (ACPE); or
- (ii) engaged in drug therapy management as allowed under previous laws or rules. A statement from the physician supervising the acts shall be sufficient documentation.
- (2) Continuing requirements. A pharmacist engaged in drug therapy management shall:
- (A) annually complete six hours of continuing education related to drug therapy offered by a provider approved by the American Council on Pharmaceutical Education (ACPE). (These hours may be applied towards the hours required for renewal of a license to practice pharmacy.)
- (B) notify the board of any change in supervising physician or change in the address where the records of drug therapy management are maintained.
(d) Supervision. Physician supervision shall be as specified in the Medical Practice Act, Chapter 157 and shall be considered adequate if the delegating physician:
- (1) is responsible for the formulation or approval of the written protocol and any patient-specific deviations from the protocol and review of the written protocol and any patient-specific deviations from the protocol at least annually and the services provided to a patient under the protocol on a schedule defined in the written protocol;
- (2) has established and maintains a physician-patient relationship with each patient provided drug therapy management by a delegated pharmacist and informs the patient that drug therapy will be managed by a pharmacist under written protocol;
- (3) is geographically located so as to be able to be physically present daily to provide medical care and supervision;
- (4) receives, on a schedule defined in the written protocol, a periodic status report on the patient, including any problem or complication encountered;
- (5) is available through direct telecommunication for consultation, assistance, and direction; and
-
- (6) determines that the pharmacist to whom the physician is delegating drug therapy management establishes and maintains a pharmacist-patient relationship with the patient.
(e) Records.
- (1) Maintenance of records.
- (A) Every record required to be kept under this section shall be kept by the pharmacist and be available, for at least two years from the date of such record, for inspecting and copying by the board or its representative and to other authorized local, state, or federal law enforcement or regulatory agencies.
- (B) Records may be maintained in an alternative data retention system, such as a data processing system or direct imaging system provided:
- (i) the records maintained in the alternative system contain all of the information required on the manual record; and
- (ii) the data processing system is capable of producing a hard copy of the record upon the request of the board, its representative, or other authorized local, state, or federal law enforcement or regulatory agencies.
- (2) Written protocol.
- (A) A copy of the written protocol and any patient-specific deviations from the protocol shall be maintained by the pharmacist.
- (B) A pharmacist shall document all interventions undertaken under the written protocol within a reasonable time of each intervention. Documentation may be maintained in the patient medication record, patient medical chart, or in a separate log.
-
- (C) A standard protocol may be used or the attending physician may develop a drug therapy management protocol for the individual patient. If a standard protocol is used, the physician shall record what deviations, if any, from the standard protocol are ordered for that patient. A pharmacist shall maintain a copy of any deviations from the standard protocol ordered by the physician.
- (D) Written protocols, including standard protocols, any patient-specific deviations from a standard protocol, and any individual patient protocol, shall be reviewed by the physician and pharmacist at least annually and revised if necessary. Such review shall be documented in the pharmacist's records. Documentation of all services provided to the patient by the pharmacist shall be reviewed by the physician on the schedule established in the protocol.
…
(g) Construction and Interpretation.
(1) As specified in the Medical Practice Act, Chapter 157, this section does not restrict the use of a pre-established health care program or restrict a physician from authorizing the provision of patient care by use of a pre-established health care program if the patient is institutionalized and the care is to be delivered in a licensed hospital with an organized medical staff that has authorized standing delegation orders, standing medical orders, or protocols.
(2) As specified in the Medical Practice Act, Chapter 157, this section may not be construed to limit, expand, or change any provision of law concerning or relating to therapeutic drug substitution or administration of medication, including the Act, §554.004.
Source Note: The provisions of this §295.13 adopted to be effective April 7, 1997, 22 TexReg 3112; amended to be effective December 19, 2001, 26 TexReg 10313
Source Note: The provisions of this §295.15 adopted to be effective October 4, 1998, 23 TexReg 9745; amended to be effective December 19, 2001, 26 TexReg 10313
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