APhA Policy Manual

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.

1. APhA supports the inclusion of pharmacogenomic analysis in the drug development/approval and postmarketing surveillance processes.

1. APhA emphasizes genomics as an essential aspect of pharmacy practice.
2. APhA recognizes pharmacists as the health care professional best suited to provide medication-related consults and services based on a patient’s genomic information. All pharmacists involved in the care of the patient should have access to relevant genomic information.
3. APhA supports processes to protect patient data confidentiality and opposes unethical utilization of genomic data.
4. APhA demands payers include pharmacists as eligible providers for covered genomic interpretation and related services to support sustainable models that optimize patient care and outcomes.
5. APhA urges pharmacy management system vendors to include functionality that uses established and adopted electronic health record standards for the exchange, storage, utilization, and documentation of clinically actionable genetic variations and actions taken by the pharmacist in the provision of patient care.
6. APhA recommends pharmacists and pharmaceutical scientists lead the collaborative development of evidence-based practice guidelines for pharmacogenomics and related services.
7. APhA recommends the inclusion of pharmacists and pharmaceutical scientists in the collaborative development of pharmacogenomics clinical support tools and resources.
8. APhA encourages pharmacists to use their professional judgment and published guidelines and resources when providing access to testing or utilizing direct-to-consumer genomic test results in their patient care services.
9. APhA urges schools and colleges of pharmacy to include clinical application of genomics as a required element of the Doctor of Pharmacy curriculum.
10. APhA encourages the creation of continuing professional development and post-graduate education and training programs for pharmacists in genomics and its clinical application to meet varying practice needs.
11. APhA encourages the funding of pharmacist-led research examining the cost effectiveness of care models that utilize pharmacists providing genomic services.

APhA recognizes the urgent need for education and training of pharmacists and student pharmacists relative to the therapeutic and diagnostic use of pharmaceutical biotechnology products. APhA, therefore, supports the continuing development and implementation of such education and training.

APhA encourages the development of appropriate educational materials and guidelines to assist pharmacists in addressing the ethical issues associated with the appropriate use of biotechnology-based products.