Reclassification of Hydrocodone, Recognition of Pharmacists as Providers Among Issues Considered
The American Society of Health-System Pharmacists (ASHP) became the first national pharmacy organization to support the reclassification of hydrocodone combination products under the Controlled Substances Act during the 65th annual session of its House of Delegates this month in Minneapolis.
Delegates also approved policies supporting changes in federal and state laws to define pharmacists as health care providers, the adoption of applicable standards of the United States Pharmacopeia to state laws and regulations governing compounding by health professionals, and training in team-based patient care for student pharmacists and residents. The session was held in conjunction with Society’s Summer Meeting.
The hydrocodone policy calls for the Drug Enforcement Administration (DEA) to reschedule hydrocodone combination products to Schedule II because of their potential for abuse and patient harm. It was developed after carefully weighing the potential public health benefit of rescheduling these therapies against concerns about restricting patients’ access to treatment and increasing administrative and other burdens on pharmacists, physicians, and other clinicians. A separate policy urges the DEA to reevaluate existing schedules of all substances regulated under the Controlled Substances Act to ensure a consistent approach to the classification of these therapies.
The House of Delegates, ASHP’s chief policy-making body, consists of 163 voting state delegates (a minimum of two from each state, the District of Columbia, and Puerto Rico), members of the Board of Directors, past presidents of ASHP, chairs of the Society’s sections and forums, and five delegates representing the federal services.
The House approved the following professional policies.
Payer Processes for Payment Authorization and Coverage Verification
To advocate that public and private payers collaborate with each other and with health care providers to create standardized and efficient processes for authorizing payment or verifying coverage for care; further, to advocate that payment authorization and coverage verification processes (1) facilitate communication among patients, providers, and payers prior to therapy; (2) provide timely payment or coverage decisions; (3) facilitate access to information that allows the pharmacist to provide prescribed medications and medication therapy management to the patient; and (4) foster continuity in patient care. (Replaces ASHP policy 1206.)
Interoperability of Patient-Care Technologies
To encourage interdisciplinary development and implementation of technical and semantic standards for health information technology (HIT) that would promote the interoperability of patient-care technologies that utilize medication-related databases (e.g., medication order processing systems, automated dispensing cabinets, intelligent infusion pumps, electronic health records); further, to encourage the integration, consolidation, and harmonization of medication-related databases used in patient-care technologies to reduce the risk that outdated, inaccurate, or conflicting data might be used and to minimize the resources required to maintain such databases.
Proliferation of Accreditation Organizations
To advocate that health care accreditation organizations include providers and patients in their accreditation and standards development processes; further, to encourage health care accreditation organizations to adopt consistent standards for the medication-use process, based on established principles of patient safety and quality of care; further, to encourage hospitals and health systems to include pharmacy practice leaders in decisions about seeking recognition by specific accreditation organizations.
Drug Product Reimbursement
To pursue, in collaboration with public and private payers, the development of improved methods of reimbursing pharmacies for the costs of drug products dispensed, compounding and dispensing services, and associated overhead; further, to educate pharmacists about those methods. (Replaces ASHP policy 0207.)
Education About Performance-Enhancing Substances
To encourage pharmacists to engage in community outreach efforts to provide education to athletes on the risks associated with the use of performance-enhancing substances; further, to encourage pharmacists to advise athletic authorities and athletes on the dangers of performance-enhancing substances and other products that are prohibited in competition; further, to advocate for the role of the pharmacist in all aspects of sports doping control. (Replaces ASHP policy 0710.)
Standardization of Intravenous Drug Concentrations
To develop nationally standardized drug concentrations and dosing units for commonly used high-risk drugs that are given as continuous infusions to adult and pediatric patients; further, to encourage all hospitals and health systems to use infusion devices that interface with their information systems and include standardized drug libraries with dosing limits, clinical advisories, and other patient-safety-enhancing capabilities; further, to encourage interprofessional collaboration on the adoption and implementation of standardized drug concentrations and dosing units in hospitals and health systems. (Replaces ASHP policy 0807.)
Pharmacist Recognition as a Health Care Provider
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.
Compounding by Health Professionals
To advocate that state laws and regulations that govern compounding by health professionals adopt the applicable standards of the United States Pharmacopeia. (Replaces ASHP policy 0411.)
Pharmacists’ Role in Immunization and Vaccines
To affirm that pharmacists have a role in improving public health and increasing patient access to immunizations by promoting and administering appropriate immunizations to patients and employees in all settings; further, to collaborate with key stakeholders to support the public health role of pharmacists and student pharmacists in the administration of adult and pediatric immunizations; further, to advocate that states grant pharmacists and appropriately supervised student pharmacists the authority to initiate and administer all adult and pediatric immunizations; further, to advocate that pharmacists and student pharmacists who have completed a training and certification program acceptable to state boards of pharmacy and meeting the standards established by the Centers for Disease Control and Prevention may provide such immunizations; further, to advocate that state and federal health authorities establish centralized databases for documenting administration of immunizations that are accessible to all health care providers; further, to advocate that state and federal health authorities require pharmacists and other immunization providers to report their documentation to these centralized databases, if available; further, to strongly encourage pharmacists to educate all patients, their caregivers, parents, guardians, and health care providers about the importance of immunizations for disease prevention; further, to encourage pharmacists to seek opportunities for involvement in disease prevention through community immunization programs; further, to advocate for the inclusion of pharmacist-provided immunization training in college of pharmacy curricula. (Replaces ASHP policies 1220 and 0213.)
Regulation of Telepharmacy Services
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. (Replaces ASHP policy 0716.)
Regulation of Centralized Order Fulfillment
To advocate changes in federal and state laws, regulations, and policies to permit centralized medication order fulfillment within health care facilities under common ownership.
To define medication overuse as use of a medication when the potential risks of using the drug outweigh the potential benefits for the patient; further, to recognize that medication overuse is inappropriate and can result in patient harm and increased overall health care costs; further, to advocate that pharmacists take a leadership role in interprofessional efforts to minimize medication overuse.
To recognize that use of drug-containing devices (also known as combination devices) has important clinical and safety implications for patient care; further, to advocate that use of such devices be documented in the patient's medical record to support clinical decision-making; further, to encourage pharmacists to participate in interprofessional efforts to evaluate and create guidance on the use of these products through the pharmacy and therapeutics committee process to ensure patient safety and promote cost-effectiveness; further, to advocate that the Food and Drug Administration (FDA) and device manufacturers increase the transparency of the FDA approval process for drug-containing devices, including access to data used to support approval; further, to encourage research that evaluates the clinical and safety implications of drug-containing devices to inform product development and guide clinical practice.
DEA Scheduling of Hydrocodone Combination Products
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
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.
Pharmacy Resident and Student Roles in New Practice Models
To promote pharmacy practice and training models that: (1) provide experiential and residency training in team-based patient care; (2) recognize and utilize the skills and knowledge of student pharmacists and residents in providing direct patient care services; (3) augment the patient care services of pharmacists through expanded roles for residents as practitioner learners; and (4) where appropriate, utilize an approach to learning and service in which a supervising pharmacist oversees the services of students, residents, and other pharmacists providing direct patient care; further, to support the assessment of the impact of these pharmacy practice and training models on the quality of learner experiences and patient care outcomes. (Replaces ASHP policy 1204.)
Education and Training in Health Care Informatics Pharmacy
To recognize the significant and vast impacts of health-system information systems, automation, and technology changes on safe and effective use of medications; further, to foster, promote, and lead the development of and participation in formal health care informatics educational programs for pharmacists, pharmacy technicians, and student pharmacists.
The delegates also approved the ASHP Statement on the Pharmacist’s Role in Substance Abuse Prevention, Education, and Assistance and the ASHP Statement on the Pharmacy Technician’s Role in Pharmacy Informatics.
ASHP is the national professional organization whose nearly 40,000 members include pharmacists, pharmacy technicians, and pharmacy students who provide patient care services in hospitals, health systems, and ambulatory clinics. For 70 years, the Society has been on the forefront of efforts to improve medication use and enhance patient safety. For more information about the wide array of ASHP activities and the many ways in which pharmacists help people make the best use of medicines, visit ASHP's website, www.ashp.org, or its consumer website, www.safemedication.com