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APhA Policy Manual

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DRUG CLASSIFICATION

Browse policies organized by category. Select a category to view the related policy statements.

1 categories • 4 policies
Biologic, Biosimilar, and Interchangeable Biologic Drug Products
BIOTECHNOLOGY DRUG CLASSIFICATION DRUG PRICING AND DISTRIBUTION DRUG PRODUCT SELECTION FEDERAL PROGRAMS AND POLICIES RESEARCH

  1. APhA urges the development of laws, regulations, and policies that facilitate patient access to and affordability of biologic products.
  2. APhA urges the Food and Drug Administration (FDA) to expedite the development of standards and pathways that will evaluate the interchangeability of biologic products.
  3. APhA recognizes the Food and Drug Administration’s (FDA) Purple Book as an authoritative reference about biologic product interchangeability within the United States.
  4. APhA opposes interchangeable biologic product substitution processes that require authorization, recordkeeping, or reporting beyond generic product substitution processes.
  5. APhA encourages scientific justification for extrapolation of indications for biologic products to ensure patient safety and optimal therapeutic outcomes.

2024
Non-execution-Related Use of Pharmaceuticals in Correctional Facilities
DRUG CLASSIFICATION DRUG PRICING AND DISTRIBUTION ETHICAL ISSUES FEDERAL PROGRAMS AND POLICIES FREEDOM OF ACCESS (FREEDOM OF CHOICE) PHARMACY PRACTICE

  1. APhA opposes drug manufacturers' refusal to supply certain drugs to correctional health services units necessary to provide medical treatment of those who are incarcerated.
  2. APhA advocates for those who are incarcerated to have an opportunity, equal to that of nonmates, to access medications that correctional healthcare providers deem medically necessary for appropriate and humane health care treatment.
  3. APhA advocates for correctional healthcare providers to have opportunity, equal to that of non-correctional healthcare providers, to access, prescribe, and procure pharmaceuticals deemed necessary for medical treatment of those incarcerated.

2024
Revisions to the Medication Classification System
DISPENSING AUTHORITY DRUG CLASSIFICATION DRUG PRODUCT SELECTION FEDERAL PROGRAMS AND POLICIES PHARMACY PRACTICE REIMBURSEMENT AND COMPENSATION

  1. APhA supports the Food and Drug Administration's (FDA) efforts to revise the drug and medical device classification paradigms for prescription and nonprescription medications and medical devices to allow greater access to certain medications and medical devices under conditions of safe use while maintaining patients' relationships with their pharmacists and other health care providers.
  2. APhA supports the implementation or modification of state laws, regulations, and policies to facilitate pharmacists’ implementation and provision of services related to a revised drug and medical device classification system.
  3. APhA supports a patient care delivery model built on coordination and communication between pharmacists and other health care team members in the evaluation and management of care delivery.
  4. APhA affirms that pharmacists are qualified to provide clinical interventions on medications and medical devices under FDA’s approved conditions of safe use.
  5. APhA urges manufacturers, FDA, and other stakeholders to include pharmacists’ input in the development and adoption of technology and standardized processes for services related to medications and medical devices under FDA’s defined conditions of safe use.
  6. APhA supports the utilization of best practices, treatment algorithms, and clinical judgment of pharmacists and other health care providers to guide the evaluation and management of care delivery related to medications and medical devices under FDA’s approved conditions of safe use.
  7. APhA encourages the inclusion of medications, medical devices, and their associated services provided under FDA’s defined conditions of safe use within health benefit coverage.
  8. APhA supports compensation of pharmacists and other health care professionals for the provision of services related to FDA’s defined conditions of safe use programs.

2024
Drug Classification System
DRUG CLASSIFICATION

  1. APhA supports restructuring the current drug classification system and drug approval process. Evidence should drive the restructuring beyond the current prescription and nonprescription classes to ensure appropriate access to medications and pharmacist services and improve medication use and outcomes.
  2. APhA encourages pharmacists to exercise their professional judgment to manage access to nonprescription medications and dietary supplements to facilitate patient/caregiver interaction with their pharmacist.

2017
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