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APhA Policy Manual

DRUG PRODUCT SELECTION

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

3 categories • 13 policies

Anti-Substitution Laws

1 Policies
Anti-Substitution Laws: Pharmacists’ Responsibility

APhA supports state substitution laws, regulations, and policies that emphasize pharmacists’ professional responsibility for determining, on the basis of available evidence, including professional literature, clinical studies, drug recalls, manufacturer reputation and other pertinent factors, that the drug products they dispense are therapeutically effective.

Therapeutic Equivalence

5 Policies
Therapeutic Equivalence

  1. APhA encourages continuing dialogue with other health care organizations on pharmacist's role in therapeutic interchange, including the formation of a task force to include representatives of pharmacy, industry, government, and medicine for the purpose of adoption of uniform terminology and definitions related to chemical, biological, and therapeutic equivalence.
  2. APhA supports the concept of therapeutic interchange of various drug products by pharmacists based on mutual arrangements between pharmacists and authorized prescribers on behalf of the care of patients.

Biologic, Biosimilar, and Interchangeable Biologic Drug Products

  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.

Legislative Restrictions on Clinical Judgment

APhA opposes the enactment of laws, regulations, and policies that would act to restrict the clinical judgments of medical practitioners and other health professionals.

Biologic Drug Products

APhA should initiate educational programs for pharmacists and other health care professionals concerning the determination of therapeutic equivalence of generic/biosimilar versions of biologic drug products

Pharmaceutical Alternates

APhA supports recognition of the pharmacist’s role in the selection of pharmaceutical alternates (i.e., drug products containing the same therapeutic moiety, but differing in salt, ester, or comparable physical/chemical form or differing in dosage form)

Uniform Designation for Drug Product Selection Authority

APhA supports having a consistent process across the country for indicating on a prescription that the prescriber does not allow the pharmacist to choose a different drug.

Non-FDA-Approved Drugs and Patient Safety

  1. APhA calls for education and collaboration among health professional organizations, federal agencies, and other stakeholders to ensure that all manufacturer, distributor, and repackaged marketed prescription drugs used in patient care have been FDA-approved as safe and effective.
  2. APhA supports initiatives aimed at closing legislative, regulatory, policy and distribution-system loopholes that facilitate market entry of new prescription drugs products without FDA approval.
  3. APhA encourages health professionals to consider FDA approval status of prescription drug products when making decisions about prescribing, dispensing, substitution, purchasing, formulary development, and in the development of pharmacy/medical education programs and drug information compendia.

Revisions to the Medication Classification System

  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.

Patient Access to Pharmacist-Prescribed Medications

  1. APhA asserts that pharmacists’ patient care services and related prescribing by pharmacists help improve patient access to care, patient outcomes, and community health, and they align with coordinated, team-based care.
  2. APhA supports increased patient access to care through pharmacist prescriptive authority models.
  3. APhA opposes requirements and restrictions that impede patient access to pharmacist-prescribed medications and related services.
  4. APhA urges prescribing pharmacists to coordinate care with patients’ other health care providers through appropriate documentation, communication, and referral.
  5. APhA advocates that medications and services associated with prescribing by pharmacists must be covered and compensated in the same manner as for other prescribers.
  6. APhA supports the right of patients to receive pharmacist-prescribed medications at the pharmacy of their choice.

Potential Conflicts of Interest in Pharmacy Practice

  1. APhA reaffirms that as health care professionals, pharmacists are expected to act in the best interest of patients when making clinical recommendations.
  2. APhA supports pharmacists using evidence-based practices to guide decisions that lead to the delivery of optimal patient care.
  3. APhA supports pharmacist development, adoption, and use of policies and procedures to manage potential conflicts of interest in practice.
  4. APhA should develop core principles that guide pharmacists in developing and using policies and procedures for identifying and managing potential conflicts of interest.

Complementary/Alternative Medications and/Integrative Health

  1. APhA supports pharmacists using professional judgment to make informed decisions regarding the appropriateness of use or the sale of complementary and alternative medicines.
  2. APhA shall assist pharmacists and student pharmacists in becoming knowledgeable about complementary and alternative medications to facilitate the counseling of patients regarding effectiveness, proper use, indications, safety, and possible interactions.

Licensure/Registration of Drug Manufacturers

APhA supports the requirements that all drug manufacturers must obtain a federal license or registration, conditioned upon an inspection of the manufacturer’s facilities before manufacturing is begun.

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