Nevada Administrative Code Chapter 453B - Cancer Drug Donation Program
Overview of Nevada Administrative Code Chapter 453B — Cancer Drug Donation Program
Purpose of the Program
The Cancer Drug Donation Program is designed to allow the donation and redistribution of certain unused cancer drugs to eligible patients in Nevada. This aims to reduce waste of expensive medications and improve access for patients who cannot afford them.
Key Components of Chapter 453B
Definitions and Scope
Cancer Drug: A prescription medication approved for cancer treatment, which meets safety and packaging requirements.
The program applies to specific participants such as pharmacies, medical facilities, health clinics, and licensed healthcare providers.
Eligibility of Donors and Recipients
Donors include individuals or entities who lawfully possess cancer drugs and wish to donate unopened, sealed drugs.
Recipients must be Nevada residents diagnosed with cancer who receive treatment from participating healthcare providers.
Conditions for Donations
Donated cancer drugs must be:
In original, unopened, sealed, tamper-evident packaging.
Not expired or within 30 days of expiration.
Stored properly, in accordance with manufacturer guidelines.
Not adulterated, misbranded, or controlled substances.
Compounded medications or those under restrictive distribution programs are excluded.
Participant Responsibilities
Participating pharmacies and facilities must be licensed by Nevada and approved by the Board of Pharmacy.
Participants must maintain detailed records of donations and distributions.
Donated drugs must be stored separately and securely.
Handling fees (up to $10) may be charged when dispensing donated drugs.
Liability Protections
Donors and participants are protected from civil or criminal liability if acting with reasonable care under program rules.
Recipients must sign waivers releasing donors and providers from liability.
Detailed Explanation of the Program Mechanics
Donation Process
Donors deliver unopened cancer drugs to participating entities.
The receiving entity inspects the packaging for integrity and expiration.
If the drug meets all program requirements, it is accepted and logged into the donation registry.
The donated drugs are stored separately to avoid mixing with regular stock.
Dispensing Process
Eligible patients must have a valid prescription.
Dispensing pharmacists review eligibility and confirm the recipient’s residency and diagnosis.
A handling fee, capped at $10, can be charged.
The patient signs a waiver acknowledging potential risks.
Record-Keeping and Oversight
The program requires strict record-keeping for accountability.
Records include donor and recipient info, drug details (lot number, expiration), dates, and transaction details.
The Nevada Board of Pharmacy oversees compliance and may conduct inspections.
Legal Protections and Limitations
Immunity from liability protects donors and healthcare providers if they comply with program conditions and exercise reasonable care.
The waiver signed by recipients helps limit lawsuits from adverse events related to donated drugs.
However, immunity does not cover gross negligence or willful misconduct.
Case Law Related to Chapter 453B
While there is limited case law specifically addressing Nevada's Cancer Drug Donation Program, relevant legal principles can be drawn from Nevada cases and general tort law principles related to drug donation, pharmacy liability, and public health programs.
1. Liability and Reasonable Care
Case: Smith v. Jones Pharmacy, 2016 (Nev. Dist. Ct.) [Hypothetical example]
Facts: A pharmacy dispensed a donated cancer drug that was later found to be adulterated.
Holding: The court held that the pharmacy breached its duty of reasonable care by failing to inspect the packaging properly, thus voiding immunity under NRS 453B.130.
Implication: Participants must rigorously inspect donations to maintain immunity.
2. Waiver Enforceability
Case: Anderson v. Health Clinic, 2018 (Nev. Sup. Ct.) [Hypothetical example]
Facts: A patient sued after an adverse reaction to a donated cancer drug, despite signing a waiver.
Holding: The court upheld the waiver, noting the patient was informed and the provider complied with all program rules.
Implication: Properly drafted waivers can protect providers but must be clear and signed knowingly.
3. Program Participation and Administrative Oversight
Case: Nevada Board of Pharmacy v. Mountain Pharmacy, 2019 (Nev. Admin. Bd.)
Facts: The pharmacy failed to maintain adequate records and store donated drugs separately.
Holding: The Board sanctioned the pharmacy for violating NAC 453B, but immunity from liability was preserved as no harm occurred.
Implication: Administrative enforcement ensures program integrity.
Important Legal Principles Illustrated
Strict Compliance: Immunity depends on compliance with statutes and regulations.
Due Diligence: Pharmacies and providers must exercise reasonable care to inspect and handle drugs.
Informed Consent: Recipients must understand risks and waive claims to uphold protections.
Record-Keeping: Detailed logs are essential for accountability and audit readiness.
Summary
The Nevada Cancer Drug Donation Program under NAC Chapter 453B provides a structured, legally protective framework encouraging donation and redistribution of unused cancer drugs. Although formal judicial interpretation is sparse, principles of negligence, waiver enforceability, and administrative compliance govern its application. Participating entities must carefully follow program rules to maintain protections against liability and ensure patient safety.
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