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Government, Law, and Regulation
Source: Council on Pharmacy Practice
To advocate that the Centers for Medicare & Medicaid Services (1) remove the requirement in the Hospital Conditions of Participation that all medication orders automatically stop after an arbitrarily assigned period to include other options to protect patients from indefinite, open-ended medication orders, and (2) revise the remainder of the medication management regulations and interpretive guidelines to be consistent with this practice; further,
To affirm that the requirement for automatic stop orders for all medications is a potential source of medication errors and patient harm; further,
To encourage pharmacists to participate in interprofessional efforts to establish standardized methods to assure appropriate duration of therapy.
This policy supersedes ASHP policy 0904.
Federal and State Regulation of Compounding (1406)
Source: Council on Public Policy
To advocate that the applicable compendial standards of the United States Pharmacopeia be included in state and federal laws and regulations that govern compounding by any health professional; further,
To advocate for mandatory state registration of compounding facilities (e.g., pharmacies, physician offices, clinics, ambulatory surgery centers) that provide products for specific patient prescriptions or in anticipation of specific patient prescriptions or medication orders; further,
To advocate for mandatory Food and Drug Administration registration and current good manufacturing practices requirements for outsourcing facilities that compound and sell products without patient-specific prescriptions across state lines; further,
To advocate for improved patient safety and care through education of regulatory inspectors, increased frequency and improved effectiveness of compliance inspections, and enhancing interagency communications; further,
To advocate that state and federal agencies develop standardized definitions and nomenclature relating to sterile and nonsterile compounding, including but not limited to definitions of compounding, manufacturing, repackaging, and relabeling.
This policy supersedes ASHP policy 1308.
340B Drug Pricing Program Sustainability (1407)
Source: Council on Public Policy
To affirm the intent of the federal drug pricing program (the “340B program”) to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services; further,
To advocate legislation or regulation that would optimize access to the 340B program in accordance with the intent of the program; further,
To advocate for clarification and simplification of the 340B program and any future federal discount drug pricing programs with respect to program definitions, eligibility, and compliance measures to ensure the integrity of the program; further,
To encourage pharmacy leaders to provide appropriate stewardship of the 340B program by documenting the expanded services and access created by the program; further,
To educate pharmacy leaders and health-system administrators about the internal partnerships and accountabilities and the patient-care benefits of program participation; further,
To educate health-system administrators, risk managers, and pharmacists about the resources (e.g., information technology) required to support 340B program compliance and documentation; further,
To encourage communication and education concerning expanded services and access provided by 340B participants to patients in fulfillment of its mission.
This policy supersedes ASHP policy 0506.
State Prescription Drug Monitoring Programs (1408)
Source: Council on Public Policy
To advocate for mandatory, uniform prescription drug monitoring programs that collect real-time, relevant, and standard information from all dispensing outpatient entities about controlled substances and monitored prescriptions; further,
To advocate that the design of these programs should balance the need for appropriate therapeutic management with safeguards against fraud, misuse, abuse, and diversion; further,
To advocate that such programs be structured as part of electronic health records and exchanges to allow prescribers, pharmacists, and other practitioners to proactively monitor data for appropriate assessment; further,
To advocate for full interstate integration to allow for access by prescribers, pharmacists, and other qualified designees across state lines; further,
To advocate for federal and state funding to establish and administer these programs; further,
To promote research, education, and implementation of best practices in prescription drug monitoring programs.
This policy supersedes ASHP policy 1122.
Approval of Biosimilar Medications (1409)
Source: Council on Public Policy
To encourage the development of safe and effective biosimilar medications in order to make such medications more affordable and accessible; further,
To encourage research on the safety, effectiveness, and interchangeability of biosimilar medications; further,
To support legislation and regulation to allow Food and Drug Administration (FDA) approval of biosimilar medications; further,
To support legislation and regulation to allow FDA approval of biosimilar medications that are also determined by the FDA to be interchangeable and therefore may be substituted for the reference product without the intervention of the prescriber; further,
To oppose the implementation of any state laws regarding biosimilar interchangeablity prior to finalization of FDA guidance; further,
To require postmarketing surveillance for all biosimilar medications to ensure their continued safety, effectiveness, purity, quality, identity, and strength; further,
To advocate for adequate reimbursement for biosimilar medications that are deemed interchangeable; further,
To promote and develop ASHP-directed education of pharmacists about biosimilar medications and their appropriate use within hospitals and health systems; further,
To advocate and encourage pharmacist evaluation and the application of the formulary system before biosimilar medications are used in hospitals and health systems.
This policy supersedes ASHP policy 1218.
Access to Oral Contraceptives Through an Intermediate Category of Drug Products (1410)
Source: Council on Therapeutics
To advocate that oral contraceptives be provided only under conditions that ensure safe use, including the availability of counseling to ensure appropriate self-screening and product selection; further,
To support expanded access to these products through a proposed intermediate category of drug products, as described by ASHP policy, that would be available from all pharmacists and licensed health care professionals (including pharmacists) who are authorized to prescribe medications; further,
To advocate that the proposed reclassification of these products be accompanied by coverage changes by third-party payers to ensure that patient access is not compromised and that pharmacists are reimbursed for the clinical services provided.
Expedited Pathways for FDA Drug Approval (1411)
Source: Council on Therapeutics
To support the use of expedited pathways for Food and Drug Administration (FDA) approval of new drugs that expand access to innovative therapies while protecting patient safety; further,
To advocate for the development of unique labeling requirements that would be used on an interim basis to identify products approved by these pathways in order to increase awareness of data limitations and guide clinician use of these drugs until additional evidence becomes available; further,
To advocate that the FDA be diligent in enforcing postmarketing commitments for drug products approved via expedited pathways, including utilizing its existing authority to enforce penalties when these requirements are not met; further,
To encourage research to evaluate the impact of expedited pathways on drug product development and patient care, including drug development timelines and costs, overall health care costs, patient access to care, and the effectiveness and safety of these therapies.
FDA Oversight of Laboratory-Developed Tests (1412)
Source: Council on Therapeutics
To advocate that the Food and Drug Administration be granted increased authority to regulate laboratory-developed tests as medical devices, including tests used for pharmacogenetic testing; further,
To support development of a risk-based framework for regulatory oversight of laboratory-developed tests that promotes innovation while providing a mechanism to ensure that test results are reliable, reproducible, and clinically relevant; further,
To encourage expanded availability of commercially marketed pharmacogenetic tests that would be available for use by laboratory and health care professionals to guide drug therapy.
Pharmacist Recognition as a Health Care Provider (1307)
Source: Council on Public Policy
To advocate for changes in federal (e.g., Social Security Act), state, and third-party payment programs to define pharmacists as health care providers; further,
To affirm that pharmacists, as medication-use experts, provide safe, accessible, high-quality care that is cost effective, resulting in improved patient outcomes; further,
To recognize that pharmacists, as health care providers, improve access to patient care and bridge existing gaps in health care; further,
To collaborate with key stakeholders to describe the covered direct patient-care services provided by pharmacists; further,
To pursue a standard mechanism for compensating pharmacists who provide these services.
Regulation of Telepharmacy Services (1310)
Source: Council on Public Policy
To advocate that state governments adopt laws and regulations that standardize telepharmacy practices across state lines and facilitate the use of United States-based telepharmacy services; further,
To advocate that boards of pharmacy and state agencies that regulate pharmacy practice include the following in regulations for telepharmacy services: (1) education and training of participating pharmacists; (2) education, training, certification by the Pharmacy Technician Certification Board, and licensure of participating pharmacy technicians; (3) communication and information systems requirements; (4) remote order entry, prospective order review, verification of the completed medication order before dispensing, and dispensing; (5) direct patient-care services, including medication therapy management services and patient counseling and education; (6) licensure (including reciprocity) of participating pharmacies and pharmacists; (7) service arrangements that cross state borders; (8) service arrangements within the same corporate entity or between different corporate entities; (9) service arrangements for workload relief in the point-of-care pharmacy during peak periods; (10) pharmacist access to all applicable patient information; and (11) development and monitoring of patient safety, quality, and outcomes measures; further,
To identify additional legal and professional issues in the provision of telepharmacy services to and from sites located outside the United States.
This policy supersedes ASHP policy 0716.
Regulation of Centralized Order Fulfillment (1311)
Source: Council on Public Policy
To advocate changes in federal and state laws, regulations, and policies to permit centralized medication order fulfillment within health care facilities under common ownership.
DEA Scheduling of Hydrocodone Combination Products (1314)
Source: Council on Therapeutics
To advocate that the Drug Enforcement Administration (DEA) reschedule hydrocodone combination products to Schedule II based on their potential for abuse and patient harm and to achieve consistency with scheduling of other drugs with similar abuse potential.
DEA Scheduling of Controlled Substances (1315)
Source: Council on Therapeutics
To advocate that the Drug Enforcement Administration (DEA) establish clear, measurable criteria and a transparent process for scheduling determinations; further,
To urge the DEA to use such a process to re-evaluate existing schedules for all substances regulated under the Controlled Substances Act to ensure consistency and incorporate current evidence concerning the abuse potential of these therapies; further,
To monitor the effect of DEA scheduling of products under the Controlled Substances Act and other abuse-prevention efforts (e.g., prescription drug monitoring programs) to assess the impact on patient access to these medications and on the practice burden of health care providers.
Source: Council on Public Policy
To advocate that pharmacy move toward the following model with respect to the evolving pharmacy technician workforce as the optimal approach to protecting public health and safety: (1) development and adoption of uniform state laws and regulations regarding pharmacy technicians, (2) mandatory completion of an ASHP-accredited program of education and training as a prerequisite to pharmacy technician certification, (3) mandatory certification by the Pharmacy Technician Certification Board as a prerequisite to licensure by the state board of pharmacy, and (4) licensure of pharmacy technicians by state boards of pharmacy granting the technician permission to engage in the full scope of responsibilities authorized by the state; further,
To advocate, with respect to certification, as an interim measure until the optimal model is fully implemented, that individuals be required either (1) to have completed an ASHP-accredited program of education and training or (2) to have at least one year of full-time equivalent experience as pharmacy technicians before they are eligible to become certified; further,
To advocate that all pharmacy functions be performed under the general supervision of a licensed pharmacist and that licensed pharmacists and technicians be held accountable for the quality of pharmacy services provided.
(Note: Licensure is the process by which an agency of government grants permission to an individual to engage in a given occupation upon finding that the applicant has attained the minimal degree of competency necessary to ensure that the public health, safety, and welfare will be reasonably well protected. Certification is the process by which a nongovernmental agency or association grants recognition to an individual who has met certain predetermined qualifications specified by that agency or association.)
This policy supersedes ASHP policy 0815.
Stable Funding for HRSA Office of Pharmacy Affairs (1219)
Source: Council on Public Policy
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