ASHP House Of Delegates Takes On Pressing Professional Issues In Seattle

Main Category: Pharmacy / Pharmacist
Article Date: 23 Jun 2008 - 6:00 PDT

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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 60th annual session, including criteria to determine appropriate pharmacy-department staffing levels, requirements for standardized training for pharmacy technicians, and the disclosure of excipients in drug products. The session was held June 8 and 10 in Seattle, in conjunction with the 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.

Role of Pharmacy Interns: To advocate for changes in state practice acts and regulations that would define a scope of practice for pharmacy interns that is not limited to that of a pharmacy technician; further, to explore and promote new staffing models that foster expanded roles for pharmacy interns, providing work experiences that build upon their knowledge and help them develop as future pharmacists.

Standardized Pharmacy Technician Training as a Prerequisite for Certification: To advocate that completion of an ASHP-accredited pharmacy technician training program be a prerequisite for the Pharmacy Technician Certification Examination.

Collaboration Regarding Experiential Education: To promote collaboration of health-system teaching sites with the colleges of pharmacy (nationally or regionally), for the purpose of fostering preceptor development, standardization of experiential rotation schedule dates and evaluation tools, and other related matters.

Entry-Level Doctor of Pharmacy Degree: To be an active participant in the Accreditation Council for Pharmacy Education (ACPE) process for the revision of accreditation standards for entry-level education in pharmacy; further, to actively monitor the long-range impact that the single entry-level degree will have on residency education, availability of experiential training sites, graduate education, and continuing education programs, and the resulting health-system pharmacist applicant pool. (Replaces ASHP policy 9809.)

Health-System Use of Medications and Administration Devices Supplied Directly to Patients: To encourage hospitals and health systems not to permit administration of medications brought to the hospital or clinic by the patient or caregiver when storage conditions or the source cannot be verified unless it is determined that the risk of not using such a medication exceeds the risk of using it; further, to support care models in which medications are prepared for patient administration by the pharmacy and are obtained from a licensed, verified source; further, to encourage hospitals and health systems not to permit the use of medication administration devices with which the staff is unfamiliar (e.g., devices brought in by patients) unless it is determined that the risk of not using such a device exceeds the risk of using it; further, to advocate adequate reimbursement for preparation, order review, and other costs associated with the safe provision and administration of medications and use of related devices. (Replaces ASHP policy 0706)

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; 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.

Disclosure of Excipients in Drug Products: To advocate that manufacturers declare the name and derivative source of all excipients in drug products on the official label. (Note: Derivative source means the botanical, animal, or other source from which the excipient is originally derived.)

Medications Derived from Biologic Sources: To encourage pharmacists to take a leadership role in their health systems for all aspects of the proper use of medications derived from biologic sources, including preparation, storage, control, distribution, administration procedures, safe handling, and therapeutic applications; further, to facilitate education of pharmacists about the proper use of medications derived from biologic sources. (Note: Section 351(a) of the Public Health Service Act [42 U.S.C. 262(a)] defines biological product as follows: a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or derivative of arsphenamine [or any other trivalent organic arsenic compound], applicable to the prevention, treatment, or cure of a disease or condition of human beings.) [Replaces ASHP policy 0316.]

Education, Prevention, and Enforcement Concerning Workplace Violence: To advocate that federal, state, and local governments recognize the risks and consequences of workplace violence in the pharmacy community and enact appropriate criminal penalties; further, to collaborate with federal, state, and local law enforcement and other government authorities on methods for early detection and prevention of workplace violence; further, to encourage all workplace environments to develop and implement a policy for pharmacy personnel that (1) educates about prevention and deterrence of workplace violence, (2) identifies escalating situations that can lead to violence and instructs employees on protection and self-defense, and (3) provides continued support and care to heal personnel who were directly or indirectly involved in an incident of workplace violence; further, to encourage the health care community to develop and maintain a communication network to share information about incidents of potential and real workplace violence.

Regulation of Dietary Supplements: To advocate that Congress grant authority to the Food and Drug Administration (FDA) to (1) require that dietary supplements undergo FDA approval for evidence of safety and efficacy; (2) mandate FDA-approved dietary supplement labeling that includes disclosure of excipients; (3) mandate FDA-approved patient information materials that describe safe use in a clear, standardized format, including the potential for interaction with medications and cautions for special populations; and (4) establish and maintain an adverse-event reporting system specifically for dietary supplements, and require dietary supplement manufacturers to report suspected adverse reactions to the FDA; further, to oppose direct-to-consumer advertising of dietary supplements unless the following criteria are met: (1) federal laws are amended to include all the requirements described above to ensure that dietary supplements are safe and effective; (2) evidence-based information regarding safety and efficacy is provided in a format that allows for informed decision-making by the consumer; (3) the advertising includes a recommendation to consult with a health care professional before initiating use; (4) any known warnings or precautions regarding dietary supplement-medication interactions or dietary supplement-disease interactions are provided as part of the advertising; and (5) the advertising is educational in nature and includes pharmacists as a source of information.

(Note: Dietary supplement as used in this policy is defined by the Dietary Supplement Health and Education Act of 1994, as amended; 21 U.S.C. 321.)

Appropriate Staffing Levels: To advocate that pharmacists at each practice site base the site's pharmacist and technician staffing levels on patient safety considerations, taking into account factors such as (1) acuity of care, (2) breadth of services, (3) historical safety data, and (4) results of research on the relationship between staffing patterns and patient safety; further, to advocate that regulatory bodies not mandate specific, uniform pharmacy personnel ratios but rather ensure that site-specific staffing levels optimize patient safety; further, to encourage additional research on the relationship between pharmacy staffing patterns and patient safety. (Replaces ASHP policy 0717.)

Medicare Prescription Drug Benefit: To strongly advocate a fully funded prescription drug program for eligible Medicare beneficiaries that maintains continuity of care and ensures the best use of medications; further, to advocate that essential requirements in the program include (1) appropriate product reimbursement; (2) affordability for patients, including elimination of coverage gaps; (3) payment for indirect costs and practice expenses related to the provision of pharmacist services, based on a study of those costs; (4) appropriate coverage and payment for patient care services provided by pharmacists; (5) open access to the pharmacy provider of the patient's choice; (6) formularies with sufficient flexibility to allow access to medically necessary drugs; and (7) well-publicized, unbiased resources to assist beneficiaries in enrolling in the most appropriate plan for their medication needs. (Replaces ASHP policy 072).

(Note: Fully funded means the federal government will make adequate funds available to fully cover the Medicare program's share of prescription drug program costs; eligible means the federal government may establish criteria by which Medicare beneficiaries qualify for the prescription drug program.)

Federal Review of Anticompetitive Practices by Drug Product Manufacturers: To strongly oppose anticompetitive practices by manufacturers that adversely affect drug product availability and price; further, to encourage appropriate federal review of these practices. (Replaces ASHP policy 0520.)

Uniform State Laws and Regulations Regarding Pharmacy Technicians: To advocate that pharmacy move toward the following model with respect to technicians 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; and (3) mandatory certification by the Pharmacy Technician Certification Board as a prerequisite to the state board of pharmacy granting the technician permission to engage in the full scope of responsibilities authorized by the state; further, to advocate registration of pharmacy technicians by state boards of pharmacy; 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 licensed pharmacists be held accountable for the quality of pharmacy services provided and the actions of pharmacy technicians under their charge. (Replaces ASHP policy 0412.)

(Note: 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. Registration is the process of making a list or being enrolled in an existing list; registration should be used to help safeguard the public through interstate and intrastate tracking of the technician work force and preventing individuals with documented problems from serving as pharmacy technicians.)

Pharmacist's Leadership Role in Anticoagulation Therapy Management: To advocate that pharmacists provide leadership in the interdisciplinary development, implementation, maintenance, effectiveness monitoring, and assurance of continuity of care of anticoagulation management programs; further, to advocate that pharmacists be responsible for coordinating the individualized care of patients within anticoagulation management programs; further, to encourage pharmacists who participate in anticoagulation programs to educate patients, caregivers, prescribers, and staff about anticoagulant medication uses, drug interactions, adverse effects, the importance of adhering to therapy, and recommended laboratory testing and other monitoring.

Generic Substitution of Narrow Therapeutic Index Drugs: To support the current processes used by the Food and Drug Administration (FDA) to determine bioequivalence of generic drug products, including those with a narrow therapeutic index, and to recognize the authority of the FDA to decide if additional studies are necessary to determine equivalence; further, to oppose a blanket restriction on generic substitution for any medication or medication class without evidence from well-designed, independent studies that demonstrate inferior efficacy or safety of the generic drug product.

Alternative Drug Coding Systems: To encourage federal agencies, the pharmaceutical industry, pharmacy and medical software providers, and purveyors of clinical data repositories and drug databases to explore the potential benefits of supplementing or modifying the National Drug Code with a coding system that can be effectively used across the medication-use continuum.

ASHP Statements

Delegates approved the following ASHP Statements, which are documents that elaborate on best practices in health-system pharmacy. These documents may be obtained from the ASHP Web site or by contacting the ASHP Public Relations Division.

- ASHP Statement on Bar-Code-Enabled Medication Administration
- ASHP Statement on the Roles and Responsibilities of the Pharmacy Executive
- ASHP Statement on Standards-Based Pharmacy Practice in Hospitals and Health Systems
- ASHP Statement on Pharmacy Services to the Emergency Department
- ASHP Statement on the Pharmacy and Therapeutics Committee and the Formulary System (This statement replaces the ASHP Statement on the Pharmacy and Therapeutics Committee dated June 1, 1992, and the ASHP Statement on the Formulary System dated June 7, 1983.)
- ASHP Statement on Confidentiality of Patient Health Care Information (This statement supersedes a previous version dated June 7, 1999.)
- ASHP Statement on Criteria for an Intermediate Category of Drug Products

About ASHP

For more than 60 years, ASHP has helped pharmacists who practice in hospitals and health systems improve medication use and enhance patient safety. The Society's 30,000 members include pharmacists and pharmacy technicians who practice in inpatient, outpatient, home-care, and long-term-care settings, as well as pharmacy students. 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 Web site, http://www.ashp.org, or its consumer Web site, http://www.SafeMedication.com.

http://www.ashp.org