APhA Policy Manual

1. APhA advocates for laws, regulations, and policies that establish reasonable out-of-pocket patient costs for evidence-based, guideline-recommended, or standard of care therapies to enhance affordability and ensure access to appropriate treatments from a patient’s preferred pharmacy.
2. APhA advocates for laws, regulations, and policies that allow for sustained access to evidence-based, guideline-recommended, or standard of care therapies after a patient has met treatment goals.

1. APhA supports enactment and enforcement of laws, regulations and policies intended to prevent Organized Retail Crime (ORC) from occurring in our communities.
2. APhA calls on all relevant authorities to enforce laws, regulations, and policies to hold online marketplaces accountable for verifying third-party sellers on their platforms.

APhA advocates for laws, regulations, and policies that recognize access to quality and affordable essential medicines as a fundamental human right.

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 asserts that pharmacists, student pharmacists, pharmacy technicians, and pharmacy support staff are essential members of the healthcare team and should be actively engaged and supported in surveillance, mitigation, preparedness, planning, response, recovery, and countermeasure activities related to public health and other emergencies.
2. APhA reaffirms the 2016 policy on the Role of the Pharmacist in National Defense, and calls for the active and coordinated engagement of all pharmacists in public health and other emergency planning and response activities.
3. APhA advocates for the timely removal of legal, regulatory, and policy restrictions; practice limitations; and financial barriers during public health and other emergencies to meet immediate patient care needs.
4. APhA urges regulatory bodies and government agencies to recognize pharmacists' training and ability to evaluate patient needs, provide care, and appropriately refer patients during public health and other emergencies.
5. APhA advocates for pharmacists’ authority to ensure patient access to care through the prescribing, dispensing, and administering of medications, as well as provision of other patient care services during times of public health and other emergencies.
6. APhA calls for processes to ensure that any willing and able pharmacy and pharmacy practitioner is not excluded from providing pharmacist patient care services during public health and other emergencies.
7. APhA calls on public and private payers to establish and implement payment policies that compensate pharmacists providing patient care services, including during public health and other emergencies, within their recognized authority.
8. APhA advocates for the inclusion of pharmacists as essential members in the planning, development, and implementation of alternate care sites or delivery models during public health and other emergencies.
9. APhA reaffirms the 2015 Interoperability of Communications Among Health Care Providers to Improve Quality of Care and encourages pharmacists, as members of the healthcare team, to communicate care decisions made during public health and other emergencies with other members of the healthcare team to ensure continuity of care.

APhA opposes distribution programs, laws, regulations, and policies by manufacturers, governmental agencies, and voluntary health groups that circumvent the pharmacist and promote the dispensing of prescription, legend drugs by non-pharmacists. These programs and policies should, in the public interest, be eliminated.

1. APhA supports the immediate reporting by manufacturers to the U.S. Food and Drug Administration (FDA) of disruptions that may impact the market supply of medically necessary drug products to prevent, mitigate, or resolve drug shortage issues and supports the authority for FDA to impose penalties for failing to report.
2. APhA supports revising current laws, regulations, and policies that restrict the FDA’s ability to provide timely communication to pharmacists, other health care providers, health systems, and professional associations regarding potential or real drug shortages.
3. APhA encourages the FDA, the Drug Enforcement Administration (DEA), and other stakeholders to collaborate in order to minimize barriers (e.g., aggregate production quotas, annual assessment of needs, unapproved drug initiatives) that contribute to or exacerbate drug shortages.
4. APhA should actively support legislation to hasten the development of an efficient regulatory process to approve therapeutically equivalent generic versions of biologic drug products.
5. APhA encourages pharmacists and other health care providers to assist in maintaining continuity of care during drug shortage situations by (a) creating a practice site drug shortage plan as well as policies and procedures; (b) using reputable drug shortage management and information resources in decision making; (c) communicating with patients and coordinating with other health care providers; (d) avoiding excessive ordering and stockpiling of drugs; (e) acquiring drugs from reputable distributors; and (f) heightening their awareness of the potential for counterfeit or adulterated drugs entering the drug distribution system.
6. APhA encourages accrediting and regulatory agencies and the pharmaceutical science and manufacturing communities to evaluate policies/procedures related to the establishment and use of drug expiration dates and any impact those policies/procedures may have on drug shortages.
7. APhA encourages the active investigation and appropriate prosecution of entities that engage in price gouging and profiteering of medically necessary drug products in response to drug shortages.

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.

1. APhA supports access to third-party (non-patient recipient) prescriptions for opioid reversal agents that are independently prescribed by pharmacists.
2. APhA affirms that third-party (non-patient-recipient) prescriptions should be reimbursed by public and private payers.

1. APhA urges government authorities to hold pharmaceutical manufacturers, wholesalers, pharmacies, and other pharmaceutical supply distributors and providers accountable to state and federal price gouging laws, regulations and policies in selling those items to patients, pharmacies, hospitals, and other health care providers during times of local, state, or national emergency.
2. APhA urges government authorities to aggressively enforce laws and regulations against adulterated products and false and misleading claims by entities offering to sell pharmaceutical and medical products to health care providers and consumers.

APhA opposes any laws, regulations, and policies that would grant FDA authority to restrict the channels of drug distribution for any prescription drug as a condition for approval for marketing the drug under approved labeling.

1. APhA asserts that the quality and safety of pharmaceutical and other medical products and the global pharmaceutical and medical product supply chain are essential to the United States national security and public health.
2. APhA advocates for pharmacist engagement in the development and implementation of national and global strategies to ensure the availability, quality, and safety of pharmaceutical and other medical products.
3. APhA calls for the development, implementation, and oversight of enhanced and transparent processes, standards, and information that ensure quality and safety of all pharmaceutical ingredients and manufacturing processes.
4. APhA calls on the federal government to penalize entities who create barriers that threaten the availability, quality, and safety of United States pharmaceutical and other medical product supplies.
5. APhA calls for the development of redundancy and risk mitigation strategies in the manufacturing process to ensure reliable and consistent availability of safe and high-quality pharmaceutical and other medical products.
6. APhA advocates for legal regulatory, policy, and market incentives that bolster the availability, quality, and safety of pharmaceutical and other medical products.
7. APhA calls for greater transparency, accuracy, and timeliness of information and notification to health care professionals regarding drug shortages, product quality and manufacturing issues, supply disruption, and recalls.
8. APhA encourages pharmacy providers, health systems, and payers to develop coordinated response plans, including the use of therapeutic alternatives, to mitigate the impact of drug shortages and supply disruptions.
9. APhA supports federal legislation and regulations that engages pharmacists, other health professionals, and manufacturers in developing a United States-specific essential medicines list and provides funding mechanisms to ensure consistent availability of these products.
10. APhA recommends the use of pharmacists in the delivery of public messages, through media and other communication channels, regarding pharmaceutical supply and quality issues.

1. APhA supports public education about the risk of using medications whose production, distribution, or sale does not comply with U.S. federal and state laws, regulations, and policies.
2. APhA urges pharmacists and other health care professionals to report suspected counterfeit products to the Food and Drug Administration.

1. APhA recognizes geographic proximity and transportation to pharmacies as key determinants in equitable access to medications, vaccines, and patient care services.
2. APhA calls for laws, regulations, and policies that reduce pharmacy shortage areas and ensure equitable access to essential services.
3. APhA supports the development of financial incentives to establish physical pharmacy locations in pharmacy shortage areas and to prevent the closure of pharmacies in underserved areas.

APhA calls for commensurate compensation for the provision of compulsory or mandated pharmacy services that include all products, supplies, labor, expertise, and administrative fees based on transparent economic analyses of existing and future services.

APhA supports coordination of patients’ comprehensive pharmacy and medical benefits that allows for provision of and compensation for pharmacists’ patient care services; aligns incentives to optimize patient outcomes; streamlines administrative processes; reduces overall health care costs and preserves patients’ right to choose providers under their pharmacy and medical benefits.

1. APhA recognizes that certain complex medications require more specialized care and resources. Further, APhA asserts that delineation of medications as specialty versus non-specialty, and associated payer and manufacturer practices, may introduce continuity of care disruption, patient access issues, and financial inequities.
2. APhA supports pharmacists and pharmacies choosing to specialize or incorporate specialty pharmacy services into their practice to optimize patient outcomes.
3. APhA opposes payer policies and practices that limit patient choice of pharmacy providers, disrupt continuity of care, or compromise patient safety through the creation of specialty drug lists, and restrictive specialty pharmacy networks.
4. APhA opposes manufacturer distribution and related business practices that restrict patient or pharmacy access to medications, medical products, and patient care services.
5. APhA advocates for the adoption of pharmacy profession-developed, harmonized practice standards for specialized pharmacy practices, and specialty pharmacy services and products.
6. APhA encourages increased availability and use of data integration, patient financial assistance, and other resources to inform clinical practice and support the provision of specialized pharmacy practices and specialty pharmacy services.
7. APhA supports the availability of education and training for pharmacists and student pharmacists related to specialized pharmacy practices and specialty pharmacy services.

APhA advocates the elimination of coupons, rebates, discounts, and other incentives provided to patients that promote the transfer of prescriptions between competitors.

APhA supports pharmaceutical industry adoption of a “transparent pricing” system that would eliminate hidden discounts, free goods, and other subtle economic devices.

APhA opposes any manufacturer–provider relationship that involves product licensing agreements and/or restricted distribution arrangements that infringe on pharmacists’ rights to provide pharmaceuticals and pharmaceutical care to their patients.

APhA encourages the development and use of quality-control procedures by all persons or entities involved in the distribution and dispensing of drug products. Such procedures should assure drug product integrity and stability in accordance with official compendia standards.

APhA supports a system of equal opportunity with the same terms, conditions, and prices available for all pharmacies.