BILL ANALYSIS |
|
C.S.S.B. 1243 |
|
By: Burton |
|
Public Health |
|
Committee Report (Substituted) |
|
BACKGROUND AND PURPOSE
It has been reported that, in the United States, unused medications may account for as much as $1 billion each year in wasted drug costs. Interested parties assert that the majority of the medications are left unused, especially in the nursing home setting, as a result of a change in prescription, a death, or the transfer of a patient or resident and that many of these medications remain in the manufacturer's original, sealed, and tamper-evident bulk unit of dose packaging known as a blister pack. The parties, noting that many states have enacted laws and programs to recycle such unused medications, contend that these medications are wasted at the expense of taxpayers. C.S.S.B. 1243 seeks to establish a similar program in Texas.
|
||||||||||||||||||
|
CRIMINAL JUSTICE IMPACT
It is the committee's opinion that this bill does not expressly create a criminal offense, increase the punishment for an existing criminal offense or category of offenses, or change the eligibility of a person for community supervision, parole, or mandatory supervision.
|
||||||||||||||||||
|
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.
|
||||||||||||||||||
|
ANALYSIS
C.S.S.B. 1243 amends the Health and Safety Code to require the Department of State Health Services (DSHS) to establish a pilot program for the donation and redistribution of prescription drugs and conduct the pilot program in one or more municipalities with a population of more than 500,000 but less than one million. The bill authorizes a charitable drug donor to donate certain unused prescription drugs to DSHS for the pilot program. The bill defines "charitable drug donor" as a licensed convalescent or nursing facility or related institution, licensed hospice, hospital, physician, or pharmacy; a pharmaceutical seller or manufacturer that donates drugs under a qualified patient assistance program; or the licensed health care professional responsible for administration of drugs in a penal institution in Texas.
C.S.S.B. 1243 requires a charitable drug donor to use appropriate safeguards established by DSHS rule to ensure that the drugs are not compromised or illegally diverted while being stored or transported. The bill prohibits DSHS from accepting the donated drugs unless the charitable drug donor certifies that the drugs have been properly stored while in the possession of the donor or of the person for whom the drugs were originally dispensed, the charitable drug donor provides DSHS with a verifiable address and telephone number, and the person transferring possession of the drugs presents photographic identification.
C.S.S.B. 1243 authorizes DSHS to accept donated drugs only in accordance with the bill's provisions. The bill requires the donated drugs to be prescription drugs approved by the U.S. Food and Drug Administration (FDA) and to be sealed in unopened tamper-evident unit dose packaging, be oral medication in sealed single-dose containers approved by the FDA, or be topical or inhalant drugs in sealed units-of-use containers approved by the FDA. The bill authorizes a drug packaged in single unit doses to be accepted and distributed if the outside packaging is opened but the single unit dose packaging is unopened. The bill prohibits the donated drugs from being the subject of a mandatory recall by a state or federal agency or a voluntary recall by a drug seller or manufacturer, being adulterated or misbranded, being a controlled substance under the Texas Controlled Substances Act, being a parenteral or injectable medication, requiring refrigeration, or expiring less than 60 days after the date of the donation. The bill authorizes DSHS to distribute the donated drugs only after a licensed pharmacist has determined that the drugs are of an acceptable integrity. The bill prohibits DSHS from charging a fee for the drugs donated under the pilot program other than a nominal handling fee to defray the costs incurred in implementing the pilot program and from reselling the drugs donated under the pilot program.
C.S.S.B. 1243 authorizes the donated drugs to be accepted and provided or administered to patients only by a charitable medical clinic as defined by the Texas Food, Drug, and Cosmetic Act, a physician's office using the drugs for patients who receive assistance from Medicaid or for other indigent health care, or a licensed health care professional responsible for administration of drugs in a penal institution in Texas. The bill requires a prescription drug provided or administered to a patient under the pilot program to be prescribed by a practitioner for use by that patient. The bill authorizes the clinic or physician providing or administering the drug to charge a nominal handling fee in an amount prescribed by DSHS rule. The bill prohibits a clinic, physician, or other licensed health care professional receiving donated drugs from reselling the drugs.
C.S.S.B. 1243 requires DSHS, not later than December 1, 2015, to establish a location to centrally store drugs donated under the pilot program for distribution to qualifying recipients and to establish and maintain an electronic database in which DSHS is required to list the name and quantity of each drug donated to DSHS under the pilot program and in which a charitable medical clinic, physician, or other licensed health care professional is authorized to search for and request donated drugs. The bill requires its provisions to be governed by DSHS rules that are designed to protect the public health and safety and that include information regarding a handling fee, database maintenance, and certain forms.
C.S.S.B. 1243 establishes that charitable drug donors, manufacturers and sellers of donated drugs, charitable medical clinics, physicians, penal institutions, and their employees acting in good faith in providing or administering prescription drugs under the pilot program are not civilly or criminally liable or subject to professional disciplinary action for harm caused by providing or administering drugs donated under the pilot program unless the harm is caused by wilful or wanton acts of negligence, conscious indifference or reckless disregard for the safety of others, or intentional conduct. This bill specifies that this limitation on liability does not apply if the harm results from the failure to comply with the bill's provisions and does not apply to a charitable medical clinic that fails to comply with the insurance provisions of the Charitable Immunity and Liability Act of 1987.
C.S.S.B. 1243 requires DSHS, not later than January 1 of each odd-numbered year, to report to the legislature on the results of the pilot program and prescribes the information to be included in the report. The bill requires DSHS, as soon as practicable after the bill's effective date, to conduct a study to determine the feasibility of establishing a program under which a hospital, a nursing facility, or another health facility may transfer to DSHS, or an entity designated by DSHS, for no payment, unused drugs the cost for which the hospital, nursing facility, or health facility received reimbursement under Medicaid and under which DSHS, or the entity designated by DSHS, distributes to public hospitals the unused drugs transferred to DSHS or the entity designated by DSHS. The bill requires DSHS, in conducting the study, to consider the rules the executive commissioner of the Health and Human Services Commission may need to adopt to implement the program described in the study, including rules that provide for certain information as specified by the bill. The bill requires DSHS, not later than September 1, 2016, to submit a report to the legislature containing the findings of the study. The bill applies only to a drug that is donated, accepted, provided, or administered on or after January 1, 2016.
|
||||||||||||||||||
|
EFFECTIVE DATE
September 1, 2015.
|
||||||||||||||||||
|
COMPARISON OF SENATE ENGROSSED AND SUBSTITUTE
While C.S.S.B. 1243 may differ from the engrossed in minor or nonsubstantive ways, the following comparison is organized and formatted in a manner that indicates the substantial differences between the engrossed and committee substitute versions of the bill.
|
||||||||||||||||||
|