Introduced Version






SENATE BILL No. 534

_____


DIGEST OF INTRODUCED BILL



Citations Affected: IC 25-26-13-2.

Synopsis: Immunizations by pharmacists. Allows a physician to delegate a pharmacist to administer immunizations to persons who are at least 18 years of age under a drug order or prescription. Requires the board of pharmacy to adopt rules concerning the qualifications, protocols, and record keeping requirements of pharmacists who administer immunizations.

Effective: July 1, 2005.





Riegsecker




    January 20, 2005, read first time and referred to Committee on Health and Provider Services.







Introduced

First Regular Session 114th General Assembly (2005)


PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana Constitution) is being amended, the text of the existing provision will appear in this style type, additions will appear in this style type, and deletions will appear in this style type.
Additions: Whenever a new statutory provision is being enacted (or a new constitutional provision adopted), the text of the new provision will appear in this style type. Also, the word NEW will appear in that style type in the introductory clause of each SECTION that adds a new provision to the Indiana Code or the Indiana Constitution.
Conflict reconciliation: Text in a statute in this style type or this style type reconciles conflicts between statutes enacted by the 2004 Regular Session of the General Assembly.

SENATE BILL No. 534



    A BILL FOR AN ACT to amend the Indiana Code concerning professions and occupations.

Be it enacted by the General Assembly of the State of Indiana:

SOURCE: IC 25-26-13-2; (05)IN0534.1.1. -->     SECTION 1. IC 25-26-13-2 IS AMENDED TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2005]: Sec. 2. As used in this chapter:
     "Administering" means the direct application of a drug to the body of a person by injection, inhalation, ingestion, or any other means.
    "Board" means the Indiana board of pharmacy.
    "Controlled drugs" are those drugs on schedules I through V of the Federal Controlled Substances Act or on schedules I through V of IC 35-48-2.
    "Counseling" means effective communication between a pharmacist and a patient concerning the contents, drug to drug interactions, route, dosage, form, directions for use, precautions, and effective use of a drug or device to improve the therapeutic outcome of the patient through the effective use of the drug or device.
    "Dispensing" means issuing one (1) or more doses of a drug in a suitable container with appropriate labeling for subsequent

administration to or use by a patient.
    "Drug" means:
        (1) articles or substances recognized in the official United States Pharmacopoeia, official National Formulary, official Homeopathic Pharmacopoeia of the United States, or any supplement to any of them;
        (2) articles or substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or animals;
        (3) articles other than food intended to affect the structure or any function of the body of man or animals; or
        (4) articles intended for use as a component of any article specified in subdivisions (1) through (3) and devices.
    "Drug order" means a written order in a hospital or other health care institution for an ultimate user for any drug or device, issued and signed by a practitioner, or an order transmitted by other means of communication from a practitioner, which is immediately reduced to writing by the pharmacist, registered nurse, or other licensed health care practitioner authorized by the hospital or institution. The order shall contain the name and bed number of the patient; the name and strength or size of the drug or device; unless specified by individual institution policy or guideline, the amount to be dispensed either in quantity or days; adequate directions for the proper use of the drug or device when it is administered to the patient; and the name of the prescriber.
    "Drug regimen review" means the retrospective, concurrent, and prospective review by a pharmacist of a patient's drug related history that includes the following areas:
        (1) Evaluation of prescriptions or drug orders and patient records for drug allergies, rational therapy contradictions, appropriate dose and route of administration, appropriate directions for use, or duplicative therapies.
        (2) Evaluation of prescriptions or drug orders and patient records for drug-drug, drug-food, drug-disease, and drug-clinical laboratory interactions.
        (3) Evaluation of prescriptions or drug orders and patient records for adverse drug reactions.
        (4) Evaluation of prescriptions or drug orders and patient records for proper utilization and optimal therapeutic outcomes.
    "Drug utilization review" means a program designed to measure and assess on a retrospective and prospective basis the proper use of drugs.
    "Device" means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article

including any component part or accessory, which is:
        (1) recognized in the official United States Pharmacopoeia, official National Formulary, or any supplement to them;
        (2) intended for use in the diagnosis of disease or other conditions or the cure, mitigation, treatment, or prevention of disease in man or other animals; or
        (3) intended to affect the structure or any function of the body of man or other animals and which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes.
    "Investigational or new drug" means any drug which is limited by state or federal law to use under professional supervision of a practitioner authorized by law to prescribe or administer such drug.
    "Legend drug" has the meaning set forth in IC 16-18-2-199.
    "License" and "permit" are interchangeable and mean a written certificate from the Indiana board of pharmacy for the practice of pharmacy or the operation of a pharmacy.
    "Nonprescription drug" means a drug that may be sold without a prescription and that is labeled for use by a patient in accordance with state and federal laws.
    "Person" means any individual, partnership, copartnership, firm, company, corporation, association, joint stock company, trust, estate, or municipality, or a legal representative or agent, unless this chapter expressly provides otherwise.
    "Practitioner" has the meaning set forth in IC 16-42-19-5.
    "Pharmacist" means a person licensed under this chapter.
    "Pharmacist extern" means a pharmacy student enrolled full-time in an approved school of pharmacy and who is working in a school sponsored, board approved program related to the practice of pharmacy.
    "Pharmacist intern" means a person who is working to secure additional hours of practice and experience prior to making application for a license to practice as a pharmacist.
    "Pharmacy" means any facility, department, or other place where prescriptions are filled or compounded and are sold, dispensed, offered, or displayed for sale and which has as its principal purpose the dispensing of drug and health supplies intended for the general health, welfare, and safety of the public, without placing any other activity on a more important level than the practice of pharmacy.
    "The practice of pharmacy" or "the practice of the profession of

pharmacy" means a patient oriented health care profession in which pharmacists interact with and counsel patients and with other health care professionals concerning drugs and devices used to enhance patients' wellness, prevent illness, and optimize the outcome of a drug or device, by accepting responsibility for performing or supervising a pharmacist intern, a pharmacist extern, or an unlicensed person under section 18(a)(4) of this chapter to do the following acts, services, and operations:
        (1) The offering of or performing of those acts, service operations, or transactions incidental to the interpretation, evaluation, and implementation of prescriptions or drug orders.
        (2) The compounding, labeling, administering, dispensing, or selling of drugs and devices, including radioactive substances, whether dispensed under a practitioner's prescription or drug order, or sold or given directly to the ultimate consumer. A physician may delegate to a pharmacist the act of administering immunizations to persons under a drug order or prescription that specifies:
            (A) the general population of persons at least eighteen (18) years of age to receive the immunization; and
            (B) the date, time, and place of administration.

        (3) The proper and safe storage and distribution of drugs and devices.
        (4) The maintenance of proper records of the receipt, storage, sale, and dispensing of drugs and devices.
        (5) Counseling, advising, and educating patients, patients' caregivers, and health care providers and professionals, as necessary, as to the contents, therapeutic values, uses, significant problems, risks, and appropriate manner of use of drugs and devices.
        (6) Assessing, recording, and reporting events related to the use of drugs or devices.
        (7) Provision of the professional acts, professional decisions, and professional services necessary to maintain all areas of a patient's pharmacy related care as specifically authorized to a pharmacist under this article.
    "Prescription" means a written order or an order transmitted by other means of communication from a practitioner to or for an ultimate user for any drug or device containing the name and address of the patient, the name and strength or size of the drug or device, the amount to be dispensed, adequate directions for the proper use of the drug or device by the patient, and the name of the practitioner issued and, if the

prescription is in written form, signed by a practitioner.
    "Prescription" means a written order or an order transmitted by other means of communication from a practitioner to or for an ultimate user for any drug or device containing:
        (1) the name and address of the patient;
        (2) the date of issue;
        (3) the name and strength or size (if applicable) of the drug or device;
        (4) the amount to be dispensed (unless indicated by directions and duration of therapy);
        (5) adequate directions for the proper use of the drug or device by the patient;
        (6) the name of the practitioner; and
        (7) the signature of the practitioner if the prescription is in written form.
    "Qualifying pharmacist" means the pharmacist who will qualify the pharmacy by being responsible to the board for the legal operations of the pharmacy under the permit.
    "Record" means all papers, letters, memoranda, notes, prescriptions, drug orders, invoices, statements, patient medication charts or files, computerized records, or other written indicia, documents or objects which are used in any way in connection with the purchase, sale, or handling of any drug or device.
    "Sale" means every sale and includes:
        (1) manufacturing, processing, transporting, handling, packaging, or any other production, preparation, or repackaging;
        (2) exposure, offer, or any other proffer;
        (3) holding, storing, or any other possession;
        (4) dispensing, giving, delivering, or any other supplying; and
        (5) applying, administering, or any other using.

SOURCE: ; (05)IN0534.1.2. -->     SECTION 2. [EFFECTIVE JULY 1, 2005] (a) Before July 1, 2006, the Indiana board of pharmacy, in consultation with the Indiana medical licensing board, shall adopt rules under IC 4-22-2 concerning the qualifications, protocols, and record keeping requirements for a pharmacist to administer immunizations under IC 25-26-13-2, as amended by this act. The rules must include the following:
        (1) The pharmacist has completed an accredited training program.
        (2) The pharmacist is certified in cardiopulmonary resuscitation (CPR).
        (3) The pharmacist is prohibited from delegating the

administration of the immunization to another person.
        (4) The pharmacist must report adverse events.
    (b) This SECTION expires July 1, 2006.