Drug Shortages And Biosimilars - NAPLEX

Supply issue that affects pharmacy preparation or patient care when alternatives are needed. ASHP emphasizes practical impacts on pharmacy operations and patient care, differing from FDA's supply-demand focus.

Manufacturing and quality problems (e.g., GMP failures, remediation). Sterile injectables often face shortages due to stringent manufacturing standards and frequent quality control issues.

Limited manufacturers and single-source API or component suppliers. Generic injectables rely on few producers, making the supply chain susceptible to disruptions from any single point of failure.

Check FDA shortage list and wholesaler availability for the specific NDC. Consulting official sources distinguishes between localized issues and widespread national shortages affecting availability.

Verify inventory and usage rate, then implement conservation and alternative therapy plan. Assessing current stock and usage enables proactive planning to extend supply and minimize disruptions in care.

Use institution-wide criteria with stewardship and documented prioritization. Institution-wide criteria ensure fair distribution based on clinical need, guided by ethical and stewardship principles.

FDA Drug Shortages database. The FDA database provides official, up-to-date information on national shortages, serving as the authoritative source for healthcare professionals.

A supply issue that affects how a drug is prepared, dispensed, or used. This captures the FDA's focus on disruptions impacting drug availability and healthcare delivery processes.

CDER (Center for Drug Evaluation and Research). CDER oversees the approval and post-market surveillance of most therapeutic drugs, making it central to managing their shortages.

CBER (Center for Biologics Evaluation and Research). CBER specializes in regulating complex biological products, ensuring targeted oversight for shortages in vaccines and related items.

Interchangeable. This designation requires evidence of safe switching, allowing pharmacists to substitute without prescriber involvement under state laws.

Biologics are not identical; biosimilars are highly similar, not exact copies. Biological products are complex and variable, so biosimilars must prove high similarity rather than exact replication.

Approval for additional reference-product indications without direct clinical trials in each indication. Extrapolation relies on scientific justification from similarity data, reducing the need for redundant clinical studies.

Nonproprietary name with a 4-letter, FDA-designated suffix (e.g., -abcd). The suffix enhances pharmacovigilance by enabling precise identification and tracking of specific biologic products.

FDA enforcement discretion for importation during a medically necessary shortage. FDA may temporarily waive certain regulations to allow importation of unapproved drugs to address critical shortages.

Document product and manufacturer (brand name and suffix) to support traceability. Detailed documentation facilitates adverse event reporting and traceability to the exact product in post-marketing surveillance.

Use therapeutic interchange policy and ensure consistent product selection to reduce switching errors. Formulary policies promote safe substitution of biosimilars, ensuring supply stability and reducing risks from frequent changes.

Notify FDA in advance of discontinuance or interruption for medically necessary drugs. Advance notification allows FDA to mitigate impacts by identifying alternatives or expediting approvals.

A biosimilar expected to produce the same clinical result and allow pharmacy substitution per state law. Interchangeability designation involves additional switching studies to confirm equivalent outcomes, enabling automatic substitution.

Avoid purchase if possible; verify pedigree and report suspicious activity per policy. Gray-market sources pose risks of counterfeit or substandard drugs, necessitating caution and regulatory compliance.

Public Health Service Act (PHS Act) via the BPCIA pathway. The BPCIA amends the PHS Act to provide an abbreviated licensure pathway for biosimilars based on similarity to reference products.

No clinically meaningful differences from the reference product. FDA approval requires extensive analytical, animal, and clinical data showing equivalence in key quality attributes.

Medication errors from substitutions, concentration changes, or unfamiliar products. Shortages necessitate changes in medication use, increasing the likelihood of errors in dosing or administration.

A biologic highly similar to a reference product with no clinically meaningful differences. Biosimilars demonstrate comparable structure, function, and clinical performance to the originator biologic.