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The House of Delegates of the American Society of Health-System Pharmacists (ASHP) considered a number of vital professional issues during its 62nd annual session, including support for minimum hiring standards for pharmacy technicians, interprofessional education and training, and just culture and reporting medication errors. The session was held June 6 and 8 in Tampa, Fla. in conjunction with Society`s Summer Meeting.

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.

Policy Actions

The House approved the following professional policies.

Health Insurance Coverage for U.S. Residents

To advocate health insurance for all residents of the United States, including coverage of medications and related pharmacist patient-care services; further, to advocate that the full range of available methods be used to (1) ensure the provision of appropriate, safe, and cost-effective health care services; (2) optimize treatment outcomes; and (3) minimize overall costs without compromising quality; further, to advocate that health insurers seek to optimize continuity of care in their design of benefit plans. (Replaces ASHP policy 0512.)

Risk Evaluation and Mitigation Strategies

To advocate for research on the impact of the Food and Drug Administration`s Risk Evaluation and Mitigation Strategies (REMS) on patient safety, cost effectiveness, and pharmacy workflow; further, to advocate pharmacist involvement in the development and implementation of REMS; further, to urge computer software vendors to assist pharmacists in the identification of and compliance with REMS; further, to advocate that any REMS that include constraint on traditional drug distribution systems be consistent with ASHP policy on restricted drug distribution.

FDA Authority on Recalls

To strongly encourage the Food and Drug Administration (FDA) to develop a standard recall notification process and format to be used by all manufacturers to facilitate the timely removal of recalled drugs; further, to advocate that such notification should (1) come from a single source, (2) clearly identify the recalled product, (3) explain why the product is being recalled, (4) provide a way to report having the recalled product, (5) give instructions on what to do with the recalled product, and (6) be provided concurrently to all entities in the supply chain; further, to advocate that the FDA be given the authority to order mandatory recalls of medications; further, to urge the FDA to require drug manufacturers and the computer software industry to provide bar codes and data fields for lot number, expiration date, and other necessary and appropriate information on all medication packaging, including unit dose, unit-of-use, and injectable drug packaging, in order to facilitate compliance with recalls or withdrawals and to prevent the administration of recalled products to patients; further, to urge the FDA to encourage postmarketing reporting of adverse events and product quality issues to enhance the recall system.

Postmarketing Comparative Clinical and Pharmacoeconomic Studies

To advocate expansion of comparative clinical and pharmacoeconomic studies on the effectiveness, safety, and cost comparison of marketed medications in order to improve therapeutic outcomes and promote cost-effective medication use; further, to advocate that such studies compare a particular medication with (as appropriate) other medications, medical devices, or procedures used to treat specific diseases; further, to advocate adequate funding for the Agency for Healthcare Research and Quality and other federal agencies to carry out such studies; further, to encourage impartial private-sector entities to also conduct such studies. (Replaces ASHP policy 0513.)

Medication Therapy Management

To support medication therapy management (MTM) services as defined in Section 3503 of the Patient Protection and Affordable Care Act (PL 111-148); further, to affirm that MTM is a partnership between the patient (or a caregiver) and a pharmacist, in collaboration with other health care professionals, that promotes the safe and effective use of medications.

Definition of Meaningful Use of Health Information Technology

To advocate to policymakers (public and private) that definitions of "meaningful use of health information technology" address interoperability of medication orders and prescriptions, medication decision support and continuous improvement, and quality reporting; further, to advocate with respect to interoperability of medication orders and prescriptions that (1) a common medication vocabulary be mandated to promote the semantic interoperability of medication use across the continuum of care, because a common vocabulary is essential for comparative effectiveness research and for communicating medication information; and (2) communication of orders and electronic prescriptions must be demonstrated to be functional and semantically interoperable with pharmacy information systems; further, to advocate with respect to medication decision support and continuous improvement that (1) medication decision support should include but not be limited to allergy, drug interaction (e.g., drug-lab or drug-disease interactions), duplicate therapy, and dose-range checking; and (2) that such a decision-support service must include an ongoing, continuous improvement process to attune the decision-support service to the needs of the providers who use it; further, to advocate with respect to quality reporting that the ability to quantify improved patient safety, quality outcomes, and cost reductions in the medication-use process is essential, particularly in antimicrobial and adverse event surveillance.

Regulation of Home Medical Equipment Medication Products and Devices

To advocate for consistent regulatory oversight of all home medical equipment, with the goals of continuity of care, patient safety, and appropriate pharmacist involvement whenever equipment is used for medication administration; further, to monitor the impact of the Centers for Medicare & Medicaid Services quality standards on the accreditation of suppliers of medication-related durable medical equipment and supplies.

Employment Classification and Duty Hours of Pharmacy Residents

To advocate that pharmacy residents should be classified as exempt employees; further, to advocate that pharmacy residents be subject to duty hour limits (similar to resident physicians) with respect to all clinical and academic activities during their training program in accordance with the Accreditation Council on Graduate Medical Education (ACGME) standards and ASHP accreditation standards for pharmacy residency programs.

Preservation of Antimicrobials for Medical Treatment

To advocate that the Food and Drug Administration (FDA) eliminate future approval of antimicrobials for nontherapeutic uses in agricultural animals that represent a safety risk by contributing to antibiotic resistance; further, to encourage efforts to phase out and eliminate the nontherapeutic uses of antimicrobials previously approved by the FDA; further, to support the therapeutic use of antimicrobials in animals only under the supervision of a veterinarian; further, to encourage the FDA, Centers for Disease Control and Prevention, and other stakeholders to monitor and limit, when effective alternatives are available, the therapeutic use of antimicrobials that are essential to the treatment of critically ill human patients; further, to advocate for the inclusion of pharmacists in antimicrobial surveillance and related public health efforts based on pharmacists` knowledge of antimicrobial drug products and antimicrobial resistance.

Safety and Effectiveness of Ethanol for Treatment of Alcohol Withdrawal Syndrome

To oppose the use of oral or intravenous ethanol for the prevention or treatment of alcohol withdrawal syndrome (AWS) because of its poor effectiveness and safety profile; further, to support hospital and health-system efforts that restrict or prohibit the use of oral or intravenous ethanol therapies to treat AWS; further, to educate clinicians about the availability of alternative therapies for AWS.

Use of Surrogate Endpoints for FDA Approval of Drug Uses

To support the continued use of qualified surrogate endpoints by the Food and Drug Administration (FDA) as a mechanism to evaluate the effectiveness and safety of new drugs and new indications for existing therapies, when measurement of definitive clinical outcomes is not feasible; further, to support efforts by the FDA and other stakeholders to qualify surrogate endpoints; further, to advocate that the FDA consistently enforce existing requirements that drug product manufacturers complete postmarketing studies for drugs approved based on qualified surrogate endpoints in order to confirm that the expected improvement in outcomes occurs, and to require that these studies be completed in a timely manner.

Quality Consumer Medication Information

To support efforts by the Food and Drug Administration (FDA) and other stakeholders to improve the quality, consistency, and simplicity of written consumer medication information (CMI); further, to encourage the FDA to work in collaboration with patient advocates and other stakeholders to create evidence-based models and standards, including establishment of a universal literacy level, for CMI; further, to advocate that research be conducted to validate these models in actual-use studies in pertinent patient populations; further, to advocate that state boards of pharmacy require that pharmacies comply with FDA-established standards for content, format, and distribution of CMI.

Research on Drug Use in Obese Patients

To encourage drug product manufacturers to conduct pharmacokinetic and pharmacodynamic research in obese patients to facilitate safe and effective dosing of medications in this patient population, especially for medications most likely to be affected by obesity; further, to encourage manufacturers to include in the Food and Drug Administration (FDA)-approved labeling detailed information on characteristics of individuals enrolled in drug dosing studies; further, to advocate that the FDA develop guidance for the design and reporting of studies that support dosing recommendations in obese patients; further, to advocate for increased enrollment of obese patients in preapproval clinical trials of new medications; further, to encourage independent research on the clinical significance of obesity on drug use, as well as the reporting and dissemination of this information via published literature, patient registries, and other mechanisms.

Interprofessional Education and Training

To support interprofessional education as a component of didactic and experiential education in Doctor of Pharmacy degree programs; further, to support interprofessional education as a part of professional development for pharmacy practitioners and to collaborate with other disciplines to facilitate and promote programs that support this goal; further, to encourage and support pharmacists` collaboration with other health professionals and health care executives in the development of team-based, patient-centered care models; further, to foster documentation and dissemination of outcomes achieved as a result of interprofessional education of health care professionals. (Replaces ASHP policy 0608.)

Minimum Hiring Standards for Pharmacy Technicians

To encourage employers to hire pharmacy technicians who have successfully completed an ASHP-accredited pharmacy technician training program and are certified by the Pharmacy Technician Certification Board (PTCB); further, to support employment practices that would permit hiring of pharmacy technician trainees only if those individuals (1) are required to both successfully complete an ASHP-accredited pharmacy technician training program and successfully complete PTCB certification within 24 months of employment, and (2) are limited to positions with lesser responsibilities until they successfully complete such training and certification; further, to encourage employers to require ongoing PTCB certification as a condition of continued employment; further, to encourage expansion of ASHP-accredited pharmacy technician training programs.

Pharmaceutical Distribution Systems

To support wholesaler/distribution business models that meet the requirements of hospitals and health systems with respect to timely delivery of products, minimizing short-term outages and long-term product shortages, managing and responding to product recalls, fostering product-handling and transaction efficiency, preserving the integrity of products as they move through the supply chain, and maintaining affordable service costs. (Replaces ASHP policy 0605.)

Impact of Insurance Coverage Design on Patient Care Decisions

To advocate that all health insurance policies be designed and coverage decisions made in a way that preserves the patient-practitioner relationship; further, to oppose provisions in health insurance policies that interfere with established drug distribution and clinical services designed to ensure patient safety, quality, and continuity of care; further, to advocate for the exclusion of hospital and health-system outpatient settings from restrictive reimbursement requirements.

Standardization of Device Connections to Avoid Wrong-Route Errors

To advocate for development and use of medication administration device connectors and fittings that are designed to prevent misconnections and wrong-route errors; further, to support the use of oral syringes that are readily distinguishable from injectable syringes and connect only to oral or enteral adapters and fittings; further, to oppose the use of injectable syringes for other than injectable routes of administration; further, to identify and promote the implementation of best practices for preventing wrong-route errors.

Medication Safety Officer Role

To advocate that accountability for development and maintenance of a medication safety program in hospitals and health systems be assigned to a qualified individual (i.e., a medication safety officer or leader of a medication safety team); further, to advocate that individuals in these roles have the authority and autonomy to establish priorities for medication-use safety and make the necessary changes as authorized by the medical staff committee responsible for medication-use policy; further, to affirm that pharmacists are uniquely prepared by education, experience, and knowledge to assume the role of medication safety officer or other leadership role in all activities that ensure the safety, effectiveness, and efficiency of the medication-use process; further, to support all pharmacists in their leadership roles in organizational medication-use safety, reflecting their authority over and accountability for the performance of the medication-use process.

Role of Pharmacists in Safe Technology Implementation

To affirm the essential role of the pharmacist in the evaluation, implementation, and ongoing assessment of all technology intended to ensure safety, effectiveness, and efficiency of the medication-use process.

Just Culture and Reporting Medication Errors

To encourage pharmacists to exert leadership in establishing a just culture in their workplaces and a nonpunitive systems approach to addressing medication errors while supporting a nonthreatening reporting environment to encourage pharmacy staff and others to report actual and potential medication errors in a timely manner; further, to provide leadership in supporting a single, comprehensive, hospital- or health-system-specific medication error reporting program that (1) fosters a confidential, nonthreatening, and nonpunitive environment for the submission of medication error reports; (2) receives and analyzes these confidential reports to identify system-based causes of medication errors or potential errors; and (3) recommends and disseminates error prevention strategies; further, to provide leadership in encouraging the participation of all stakeholders in the reporting of medication errors to this program.(Note: A just culture is one that has a clear and transparent process for evaluating errors and separating events arising from flawed system design or inadvertent human error from those caused by reckless behavior, defined as a behavioral choice to consciously disregard what is known to be a substantial or unjustifiable risk.) [Replaces ASHP policy 0910.]

Patient Access to Pharmacy Services in Small and Rural Hospitals

To advocate that critical-access hospitals (CAHs) and small and rural hospitals meet national medication management and patient safety standards, regardless of size or location; further, to provide resources and tools to assist pharmacists who provide services to CAHs and small and rural hospitals in meeting standards related to safe medication use. (Replaces ASHP policy 0503.)

Scope and Hours of Pharmacy Services

To support the principle that all patients should have 24-hour access to a pharmacist responsible for their care, regardless of hospital size or location; further, to advocate alternative methods of pharmacist review of medication orders (such as remote review) before drug administration when onsite pharmacist review is not available; further, to support the use of remote medication order review systems that communicate pharmacist approval of orders electronically to the hospital`s automated medication distribution system; further, to promote the importance of pharmacist access to pertinent patient information, regardless of proximity to patient. (Replaces ASHP policy 0403.)

Use of Two Patient Identifiers in the Outpatient Setting

To encourage the use of two identifiers to confirm patient identity when transferring filled prescriptions to the possession of the patient or patient`s agent in outpatient settings.

ASHP Statements

Delegates also approved the ASHP Statement on Bar-code Verification during Inventory, Preparation, and Dispensing of Medications.

Source:
American Society of Health-System Pharmacists