IML H.B. 3075 75(R)BILL ANALYSIS PUBLIC HEALTH C.S.H.B. 3075 By: Berlanga 4-16-97 Committee Report (Substituted) BACKGROUND Home and community support services agencies are required under their licensure rules to offer their employees the Hepatitis B vaccine and tuberculosis testing, but cannot possess these immunizations under current law. Furthermore, Medicare covers influenza vaccinations for its beneficiaries, but Medicare-certified home and community support services agencies cannot possess the vaccine. If a patient's physician writes an individual order for a vaccine, a nurse from the home and community support services agency must get the prescription filled at a pharmacy and pick it up. This process may require two trips, and is especially burdensome in rural areas where the pharmacy is not in close proximity. A standing order or protocol for these vaccinations requires the agency to pick up and return the vaccine to the physician's office on the same day of the order. This is also inconvenient in rural areas, as the physician's office may not be located near the agency or the patient, and obtaining or returning the vaccine within the same day is difficult. In the administration of medications, there is always the possibility that the patient will have an adverse reaction to the treatment. Home and community support services agencies are required to obtain a patient-specific prescription for anaphylactics in such cases. Clients or patients of these services, must pay for these reaction kits, even if they are never used. For many, this is a wasted expense and a financial burden. PURPOSE CSHB 3075 allows home and community support services agencies to possess Hepatitis B and influenza vaccines, tuberculin derivative tests (TB test), and sealed anaphylactic containers under exemptions and provisions of the Pharmacy and Dangerous Drug Acts. RULEMAKING AUTHORITY It is the committee's opinion that this bill does not expressly grant any additional rulemaking authority to a state officer, department, agency or institution. SECTION BY SECTION ANALYSIS SECTION 1. Amends Subchapter A, Chapter 142, Health and Safety Code by amending Section 142.0061 and adding Sections 142.0062 and 142.0063 as follows: Section 142.0061. Retitles the section heading POSSESSION OF STERILE WATER OR SALINE. Deletes the phrase "the following dangerous drugs." Section 142.0062. POSSESSION OF CERTAIN VACCINES OR TUBERCULIN. is added as follows: Subsection (a) allows a home and community support services agency or its employees who are registered nurses or licensed vocational nurses to purchase, store, or transport the hepatitis B vaccine, influenza vaccine, and the tuberculin purified protein derivative for tuberculosis testing (TB test) for the purposes of administering this test or immunizations to the agency's employees, home health or hospice patients or patient family members under physician's standing orders. Subsection (b) requires the home and community support services agency to ensure that any standing order for the vaccine or TB test (1)is signed and dated by the physician, (2) identifies the vaccine or tuberculin, (3) indicates that the recipient is an appropriate candidate for the vaccine or test, (4) indicates that appropriate procedures are established for any negative reactions, and (5) orders the administration of a specific medication or category of medications if a recipient has a negative reaction. Section 142.0063. POSSESSION OF CERTAIN DANGEROUS DRUGS. is added as follows: Subsection (a) allows a home or community support services agency and its employees who are registered nurses or licensed vocational nurses to purchase, store, or transport for the purposes of administering to their home health or hospice patients, in accordance with Subsection (c), the items listed in this subsection in sealed portable containers of a sizes determined by the dispensing pharmacist. Subsection (b) allows a home and community support services agency or the agency's authorized employees to purchase, store, or transport dangerous drugs in a sealed portable container under this section only if the agency has established policies and procedures regarding safety and accountability as specified in this subsection. Subsection (c) allows a home and community support services agency or the agency's authorized employee who administers a drug listed in subsection (a) to administer the drug only in the patient's residence under physician's orders in connection with the provision of emergency treatment or the adjustment of (1) parenteral drug therapy, or (2) vaccine or TB test administration. Subsection (d) requires a physician to send a signed copy of an order to the agency if the home and community support services agency or the agency's authorized employee administers a drug listed in subsection (a) with a physician's oral order. Requires the agency to (1) transcribe the order and send a copy of the form to the dispensing pharmacy by mail or facsimile transmission within 24 hours, and (2) send a copy of the order as signed by and received from the physician to the dispensing pharmacy within 20 days. Subsection (e) requires a pharmacist who dispenses a sealed portable container to ensure the containers (1) have tamper proof seals; (2) have labels on the outside with a list of the contents and expiration date; and (3) remain in the pharmacy or under the control of a pharmacist, registered nurse or licensed vocational nurse. Subsection (f) requires the home and community support services agency or the agency's authorized employee to deliver the container to the dispensing pharmacy for verification of drug quality, integrity, and expiration dates by either (1) the seventh day after the date on which the seal was broken, or (2) the date for which notice is provided on the label of the container, whichever is earlier. Subsection (g) requires a pharmacy that dispenses a sealed portable container to take reasonable measures to ensure that the home and community support services agency complies with Subsection (f). Requires the pharmacy to take inventory of the drugs used from the container and restock and reseal the container before delivering the container to the agency for reuse. SECTION 2. Amends Section 483.041(c)(8), Health and Safety Code by exempting a licensed home and community support services agency acting in accordance with Chapter 142. SECTION 3. Amends Section 19(f)(4), Texas Pharmacy Act (Article 4542a-1, V.T.C.S.), by exempting a home and community support services agency that possesses a dangerous drug as authorized under new Sections 142.0062 and 142.0063. SECTION 4. Effective date of this Act is September 1, 1997. The change in law made by Section 2 is only applicable to an offense of which all elements of the offense were committed on or after the effective date. SECTION 5. Emergency Clause. COMPARISON OF ORIGINAL TO SUBSTITUTE SECTION 1. CSHB 3075 changes the title of Section 142.0061 and removes the language regarding dangerous drugs. The substitute adds two new sections, Sections 142.0062 regarding possession of certain vaccines and tuberculin and 142.0063 regarding possession of certain dangerous drugs, thereby incorporating the language of the original bill. SECTION 2. CSHB 3075 amends Section 483.041(c)(8), exempting a licensed home and community support services agency under and acting in accordance with Chapter 142. This change conforms to the addition of the two new sections in SECTION 1. SECTION 3. CSHB 3075 amends Section 19(f)(4), Texas Pharmacy Act, to exempt a home and community support services agency that possesses a dangerous drug as authorized by the newly added Sections 142.0062 and 142.0063. SECTION 4. CSHB 3075 establishes the effective date of the Act, and includes standard legislative council language regarding the law in effect as it relates to an offense committed before, on, or after the effective date. The original bill included the emergency clause in this Section. SECTION 5. CSHB 3075 emergency clause.