APhA Policy Manual

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.

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 legal, regulatory, and policy changes to further facilitate clinical research related to the clinical efficacy and safety associated with the use of cannabis and its various components.
2. APhA encourages health care provider education related to the clinical efficacy, safety, and management of patients using cannabis and its various components.
3. APhA advocates that the pharmacist collect and document information in the pharmacy patient profile about patient use of cannabis and its various components and provide appropriate patient counseling.
4. APhA supports pharmacist participation in independently prescribing cannabis and its various components when scientific data support the legitimate medical use of the products and delivery mechanisms, and federal, state, or territory laws or regulations permit pharmacists to independently prescribe them.
5. APhA opposes pharmacist involvement in independently prescribing cannabis and its various components for recreational use.

1. APhA supports labeling of all prescription and nonprescription products, as well as dietary supplement products, to indicate the presence of gluten.
2. APhA encourages manufacturers to formulate drug products without use of wheat, barley, rye, or their derivatives whenever possible.
3. APhA supports additional research on the effects of gluten intolerance and celiac malabsorption, particularly as it relates to medication absorption.
4. APhA supports pharmacist education regarding celiac disease and non-celiac gluten sensitivity.
5. APhA encourages the development of analytical methods that can accurately detect lower levels of gluten than the current standard (20 ppm) and for the establishment of evidence-based gluten-free standards for the labeling of foods, excipients, dietary supplements, and prescription and nonprescription products.

1. APhA supports establishment of pharmacy practice-based research networks (PBRNs) to strengthen the evidence base in support of pharmacists’ patient care services.
2. APhA encourages collaborations among stakeholders to determine the minimal infrastructure and resources needed to develop and implement local, regional, and nationwide networks for performing pharmacy practice-based research.
3. APhA encourages pharmacy residency programs to actively participate in pharmacy practice-based research network (PBRNs).

1. APhA affirms that pharmacists are the medication experts whose accessibility uniquely positions them to increase access to and improve quality of health care while decreasing overall costs.
2. APhA asserts that pharmacists must be recognized as the essential and accountable patient care provider on the health care team responsible for optimizing outcomes through medication therapy management (MTM).
3. APhA asserts the following:
   1. Medication Therapy Management Services: Definition and Program Criteria is the standard definition of MTM that must be recognized by all stakeholders.
   2. Medication Therapy Management in Pharmacy Practice: Core Elements of an MTM Service Model, as adopted by the profession of pharmacy, shall serve as the foundational MTM service model.
4. APhA asserts that pharmacists must be included as essential patient care provider and compensated as such in every health care model, including but not limited to, the medical home and accountable care organizations.
5. APhA actively promotes the outcomes-based studies, pilot programs, demonstration projects, and other activities that document and reconfirm pharmacists’ impact on patient health and well-being, process of care delivery, and overall health care costs.

1. APhA advocates for federal funding of scientific research and its infrastructure to improve health.
2. APhA values the United States taking a leading role in biomedical, clinical, and health services research to improve health.

1. APhA urges the sponsors of drug research to permit pharmacists to serve as principal investigators.
2. APhA encourages agencies to eliminate laws, regulations, and policies that prohibit pharmacists from being investigators, including principal investigators, in drug research or sponsors of Investigational New Drug Applications, Investigational Device Evaluations, and Animal Investigational New Drug Applications.

1. APhA recognizes that animal experiments continue to be an essential, and indeed irreplaceable, component of biomedical research and testing.
2. When animals must be used for biomedical research and testing, APhA strongly supports humane treatment and adequate laws, regulations, and policies, controls, and enforcement of appropriate measures relating to animal procurement, transportation, housing, care, and treatment.
3. APhA encourages the further development of methods of biomedical research and testing which do not require the use of animals.
4. APhA opposes laws, regulations, and policies that would penalize the properly controlled and conducted use of animals for biomedical research and testing.

1. APhA supports the use of representative populations in clinical studies, including, but not limited to protected populations such as women, persons who are underrepresented or historically marginalized, older adults, persons who are transgender and gender-diverse, and children when appropriate.
2. APhA encourages the development of research techniques which would identify possible problems not readily detected in adult clinical investigations to aid in the safe and effective evaluation of drugs in children.

1. APhA supports the study of economic, scientific, and social issues related to health care, particularly pharmaceutical services.
2. APhA urges the federal government to establish funding mechanisms for objective research to assess the impact of public policy on the health care system, particularly pharmaceutical services.
3. APhA urges that all federally-funded research addressing public policy pertaining to pharmaceutical services incorporate input from the pharmacy profession.

APhA supports access by healthcare professionals and the public to all clinical trial data derived from scientifically valid studies. APhA supports the establishment of a single, independent, publicly accessible clinical trials database that includes but is not limited to the following components:

1. includes all studies, pre and post drug approval, throughout the research period (whether completed, in-progress or discontinued)
2. clearly states the size, demographics, limitations and citations, if published, of each study listed
3. includes an interpretative statement by an independent review body regarding the purpose of the study, methodology and outcomes to assist the public in understanding the posted information in a timely manner
4. includes warnings to the public regarding inappropriate or incomplete use of the data in making clinical decisions in absence of an interpretive statement
5. the sponsor and any supporting company, organization, or partnered institution of each clinical trial listed shall be clearly identified. (This includes Clinical Research Organizations, Academic Research Organizations, Site Management Organizations or any other group that is responsible other than the investigator’s research site.)

APhA supports efforts to increase the number of pharmacists pursuing graduate education and research in the pharmaceutical sciences, including, but not limited to

1. Dissemination of information to create awareness about graduate programs and career opportunities.
2. Pursuit of increased government, industry, and foundation funding.
3. Encouragement of innovative recruitment programs and curricula to facilitate career development.

APhA recognizes the fundamental role of biomedical research in the profession of pharmacy and actively supports continued and predictable funding of NIH research.

APhA recognizes the importance of and the need for placebo-controlled trials in testing new drugs. In addition, APhA supports the use of alternative study designs (such as positive controls), as well as innovative methodologies where they appear to be appropriate and useful.

APhA supports the principle of the free dissemination and exchange of scientific information with only the following exceptions:

1. prior mutual confidentiality agreement between sponsor and researcher,
2. material that is essential to national security, and
3. legitimate trade secrets and/or proprietary information.

APhA supports modifications of patent periods for prescription drugs and drug products that would create reasonable incentives for needed research on new drugs and drug products.