1-1     By:  Madla                                             S.B. No. 786

 1-2           (In the Senate - Filed February 26, 1997; March 3, 1997, read

 1-3     first time and referred to Committee on Health and Human Services;

 1-4     April 11, 1997, reported adversely, with favorable Committee

 1-5     Substitute by the following vote:  Yeas 11, Nays 0; April 11, 1997,

 1-6     sent to printer.)

 1-7     COMMITTEE SUBSTITUTE FOR S.B. No. 786                    By:  Madla

 1-8                            A BILL TO BE ENTITLED

 1-9                                   AN ACT

1-10     relating to the authority of pharmacists to administer

1-11     immunizations and vaccinations.

1-12           BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:

1-13           SECTION 1.  Subdivision (38), Section 5, Texas Pharmacy Act

1-14     (Article 4542a-1, Vernon's Texas Civil Statutes), is amended to

1-15     read as follows:

1-16                 (38)  "Practice of pharmacy" means:

1-17                       (A)  provision of those acts or services

1-18     necessary to provide pharmaceutical care;

1-19                       (B)  interpretation and evaluation of

1-20     prescription drug orders or medication orders;

1-21                       (C)  participation in drug and device selection

1-22     as authorized by law, drug administration, drug regimen review, or

1-23     drug or drug-related research;

1-24                       (D)  provision of patient counseling;

1-25                       (E)  responsibility for:

1-26                             (i)  dispensing of prescription drug orders

1-27     or distribution of medication orders;

1-28                             (ii)  compounding and labeling of drugs and

1-29     devices, except labeling by a manufacturer, repackager, or

1-30     distributor of nonprescription drugs and commercially packaged

1-31     prescription drugs and devices;

1-32                             (iii)  proper and safe storage of drugs and

1-33     devices; or

1-34                             (iv)  maintenance of proper records for

1-35     drugs and devices; [and]

1-36                       (F)  performance of a specific act of drug

1-37     therapy management for a patient delegated to a pharmacist by a

1-38     written protocol from a physician licensed in this state in

1-39     compliance with the Medical Practice Act (Article 4495b, Vernon's

1-40     Texas Civil Statutes); and

1-41                       (G)  administration of immunizations and

1-42     vaccinations under a physician's written protocol.

1-43           SECTION 2.  Section 17, Texas Pharmacy Act (Article 4542a-1,

1-44     Vernon's Texas Civil Statutes), is amended by amending Subsection

1-45     (a) and adding Subsections (y), (z), and (aa) to read as follows:

1-46           (a)  The board is responsible for the regulation of the

1-47     practice of pharmacy in this state, including the following:

1-48                 (1)  the licensing by examination or by reciprocity of

1-49     applicants who are qualified to engage in the practice of pharmacy

1-50     and the licensing of pharmacies under this Act;

1-51                 (2)  the renewal of licenses to engage in the practice

1-52     of pharmacy and licenses to operate pharmacies;

1-53                 (3)  the determination and issuance of standards for

1-54     recognition and approval of degree requirements of colleges of

1-55     pharmacy whose graduates shall be eligible for licensing in this

1-56     state and the specification and enforcement of requirements for

1-57     practical training, including internship;

1-58                 (4)  the enforcement of those provisions of this Act

1-59     relating to the conduct or competence of pharmacists practicing in

1-60     this state and the conduct of pharmacies operating in this state

1-61     and the suspension, revocation, fining, reprimanding, cancellation,

1-62     or restriction of licenses to engage in the practice of pharmacy or

1-63     to operate a pharmacy;

1-64                 (5)  the specifications of conditions under which a

 2-1     pharmacist may administer medications, including immunizations and

 2-2     vaccinations, which at a minimum shall include the following:

 2-3                       (A)  a licensed health care provider authorized

 2-4     to administer the medication is not reasonably available to

 2-5     administer the medication;

 2-6                       (B)  failure to administer the medication, other

 2-7     than an immunization or vaccination, might result in a significant

 2-8     delay or interruption of a critical phase of drug therapy;

 2-9                       (C)  the pharmacist possesses the necessary

2-10     skill, [and] education, and certification to administer the

2-11     medication as specified by the board;

2-12                       (D)  the pharmacist notifies the appropriate

2-13     licensed health care provider responsible for the patient's care

2-14     within a reasonable time that the medication was administered;

2-15                       (E)  a pharmacist may not administer medications

2-16     to a patient where the patient resides, except in a licensed

2-17     nursing home or hospital;

2-18                       (F)  the pharmacist administers immunizations or

2-19     vaccinations under a physician's written protocol and meets the

2-20     standards established by the board;

2-21                       (G)  the authority of the pharmacist to

2-22     administer medications may not be delegated;

2-23                       (H) [(G)]  nothing in this subdivision shall be

2-24     construed to prohibit a pharmacist from preparing or manipulating

2-25     biotechnological agents or devices; and

2-26                       (I) [(H)]  nothing in this subdivision shall be

2-27     construed as prohibiting a pharmacist from performing an act

2-28     delegated by a physician in accordance with the provisions of

2-29     Subsection (d), Section 3.06, Medical Practice Act (Article 4495b,

2-30     Vernon's Texas Civil Statutes), and the pharmacist performing such

2-31     a delegated medical act shall be considered to be performing a

2-32     medical act and not as engaged in the practice of pharmacy;

2-33                 (6)  the regulation of the training, qualifications,

2-34     and employment of pharmacist-interns; and

2-35                 (7)  the enforcement of this Act and any rules adopted

2-36     under this Act.

2-37           (y)  The board by rule shall require pharmacists to notify a

2-38     physician who prescribes an immunization or vaccination within 24

2-39     hours of administering the immunization or vaccination and  shall

2-40     establish minimum education and continuing education standards for

2-41     pharmacists who administer immunizations and vaccinations.  The

2-42     standards must include Centers for Disease Prevention and Control

2-43     training, basic life support training, and hands-on training in

2-44     techniques for administering immunizations and vaccinations.

2-45           (z)  Physician supervision is considered to be adequate for

2-46     the purposes of this section if a delegating physician:

2-47                 (1)  is responsible for the formulation or approval of

2-48     the physician's order, standing medical order, standing delegation

2-49     order, or other order or protocol and periodically reviews the

2-50     order or protocol and the services provided to a patient under the

2-51     order or protocol;

2-52                 (2)  has established a physician-patient relationship

2-53     with each patient under 14 years of age and referred the patient to

2-54     the pharmacist;

2-55                 (3)  is geographically located so as to be easily

2-56     accessible to the pharmacy administering the immunization or

2-57     vaccination;

2-58                 (4)  receives, as appropriate, a periodic status report

2-59     on the patient, including any problem or complication encountered;

2-60     and

2-61                 (5)  is available through direct telecommunication for

2-62     consultation, assistance, and direction.

2-63           (aa)  The Texas State Board of Medical Examiners by rule

2-64     shall establish the minimum content of a written order or protocol.

2-65     The order or protocol may not permit the delegation of medical

2-66     diagnosis.

2-67           SECTION 3.  Subchapter E, Chapter 21, Insurance Code, is

2-68     amended by adding Article 21.53K to read as follows:

2-69           Art. 21.53K.  PROVISION OF SERVICES RELATED TO IMMUNIZATIONS

 3-1     AND VACCINATIONS UNDER MANAGED CARE PLANS

 3-2           Sec. 1.  PROHIBITION.  (a)  A managed care entity may not

 3-3     require a physician participating in a managed care plan to issue

 3-4     an immunization or vaccination protocol for an immunization or

 3-5     vaccination to be administered to an enrollee in the plan.

 3-6           (b)  This section prohibits a managed care entity from:

 3-7                 (1)  limiting benefits to enrollees for immunizations

 3-8     or vaccinations to circumstances in which an immunization or

 3-9     vaccination protocol is issued;

3-10                 (2)  providing financial incentives to physicians to

3-11     issue an immunization or vaccination protocol; or

3-12                 (3)  imposing a financial or other penalty on a

3-13     physician who refuses to issue an immunization or vaccination

3-14     protocol.

3-15           Sec. 2.  RULES.  The commissioner may adopt rules to

3-16     implement this article.

3-17           SECTION 4.  This Act takes effect September 1, 1997.

3-18           SECTION 5.  Article 21.53K, Insurance Code, as added by this

3-19     Act, applies only to a managed care plan that is delivered, issued

3-20     for delivery, or renewed on or after January 1, 1998.  A managed

3-21     care plan that is delivered, issued for delivery, or renewed before

3-22     January 1, 1998, is governed by the law as it existed immediately

3-23     before the effective date of this Act, and that law is continued in

3-24     effect for that purpose.

3-25           SECTION 6.  The importance of this legislation and the

3-26     crowded condition of the calendars in both houses create an

3-27     emergency and an imperative public necessity that the

3-28     constitutional rule requiring bills to be read on three several

3-29     days in each house be suspended, and this rule is hereby suspended.

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