Documentation and liability

Overview of American Pharmacist Association's pharmacy-based immunization delivery certificate training program.
Focus of the module: Documentation and Liability.
Learning objectives:
- Describe required documentation for vaccinations.
- Discuss immunization information systems (IIS).
- Explain national reporting systems for vaccine-related adverse events and errors.
- Understand liability risks and legal protections for authorized immunizers.

Recommendation to maintain immunization records for a lifetime; actual legal retention requirements vary by state.
Check state laws to determine retention durations, as state laws can be stricter than federal requirements.
Encourage patients to keep accessible personal immunization records.

NCVIA mandates specific documentation requirements in patient vaccination records.
Key information includes:
- Patient identity, vaccine details, and administration date.
- Provision of current Vaccine Information Statements (VISs) to patients or caregivers.
VISs outline the risks and benefits of vaccines and must be provided for relevant vaccines administered.
Availability of current VISs from CDC and Immunization Action Coalition.
For combination vaccines, provide VIS for each component.
When administrating vaccines as a series, each dose requires prior VIS provision.
Emergency Use Authorization (EUA): In cases without available VIS, share EUA fact sheets if applicable.
State laws or company policies may necessitate informed consent forms, especially for minors.

Professional responsibility to notify a patient’s primary care provider (PCP) when vaccines are administered.
State practice acts may specify vaccine reporting requirements based on age groups.
Communication of vaccination information can occur through:
- Electronic health records.
- Mail.
- State immunization information systems (IIS).

Defined by the CDC: Confidential, computer-based databases for recording immunizations in geographical areas.
IIS managed at the state level, tracking separated for major US cities.
Initial purpose: Track immunization status of children; now includes adolescents and adults.
Benefits include:
- Assessing vaccination status.
- Guiding outbreak responses.
- Identifying coverage gaps.
- Facilitating vaccine management.
Systems may update in real time or with a delay—check state specifics.
Contact state IIS for enrollment and reporting options.

National safety surveillance for vaccines run by CDC and FDA.
Monitors adverse events post-vaccination to identify safety concerns.
All immunization providers must report:
- Serious adverse events like anaphylaxis, encephalopathy, and other rare events.
Reporting is required even if uncertainty exists about the cause.
Patients can also report to VAERS.

Developed by the Institute for Safe Medication Practices to gather data on vaccine administration errors.
Aims to facilitate process improvements and education on vaccine safety.
Provides legal protection and confidentiality for submitted reports.

Overview of liability issues related to immunization delivery—complex and nuanced.
Federal Vaccine Injury Compensation Program (VICP) provides substantial protections for immunizers:
- No-fault insurance fund covers injuries from listed vaccine-related events.
- Patients file claims for damages, forfeiting their rights to punitive damage claims.
VICP requirements include providing VIS, documenting vaccinations, and reporting adverse events.
Protection is NOT absolute; negligence can still result in liability claims against providers.
Recommendations for pharmacists:
- Carry professional liability insurance specific to vaccinations.
- Ensure insurance policy includes coverage for medication administration.
- Focus on training and competency in immunization practices to enhance legal protection.

Proper documentation is crucial for patient care, legal protection, and meeting state and federal laws.
Pharmacists should maintain accurate vaccination records, ensure proper communication with healthcare providers, and stay informed on legal protections and liability issues.