CLINICAL PRIVILEGE WHITE PAPER

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Practice area 183 CLINICAL PRIVILEGE WHITE PAPER Hospital pharmacist Background Hospital pharmacists promote appropriate, effective, and safe medication use for patients within the hospital. By working as part of a health care team, they are able to closely monitor patient drug therapy and make recommendations on the selection of the best medication for a patient s condition, the correct dose, and duration of therapy. They can specifically tailor the medication choice or dose-form to be most appropriate for patients. As the experts on medicines, hospital pharmacists are trained to advise doctors, nurses, and other hospital staff on any medication issues. They counsel patients and their families about the purposes, uses, and effects of medication and any related therapies. In addition, they review drug effectiveness and participate in quality assurance programs. Some hospital pharmacists choose to specialize. Currently practitioners can be certified in practice areas like nuclear pharmacy, which involves improving and promoting health through the safe and effective use of radioactive drugs for diagnosis and therapy. Or they may choose nutrition support pharmacy, which involves promoting the maintenance/ restoration of optimal nutritional status by designing and modifying treatment according to the needs of the patient. Education for pharmacists is in the process of transition. Accreditation standards for the baccalaureate in pharmacy and doctor of pharmacy programs have been consolidated and reformed resulting in a new doctor of pharmacy program as the sole professional program in pharmacy. Those colleges and schools of pharmacy that presently offer an accredited baccalaureate in pharmacy degree are discontinuing their programs. Baccalaureate in pharmacy programs may be continued until June 30, 2004, enabling graduation of students who had already entered an accredited program. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) currently is proposing revisions to the medication use standards in its Comprehensive Accreditation Manual for Hospitals. Hospital pharmacists are particularly concerned about one JCAHO proposal that applies when medications are entered by a physician into a computerized physician order entry (CPOE) system that has an active physician alert mechanism and a working, approved set of appropriate checks and balances. In this case, the standard only requires that the pharmacist perform a retrospective review, as soon as possible, after administration of the drug. Pharmacists believe that the use of CPOE is a way to improve safety, efficiency, and accuracy of the medication-use process. However, they do not believe that it is safe to view CPOE as a replacement for the critical role of the pharmacist to ensure the accuracy and appropriateness of orders entered into a CPOE system. Pharmacists should continue to make a prospective review of medication orders, even when CPOE systems are being used. A supplement to Briefings on Credentialing 781/639-1872 05/02 1

Positions of societies and academies APhA According to the American Pharmaceutical Association (APhA), the practice of pharmacy within each state is regulated by the laws of the state, including the regulation of licensure for pharmacy practice. To practice pharmacy in any state, a pharmacist must become a registered pharmacist (RPh), also known as a licensed pharmacist. State boards of pharmacy license pharmacists. Requirements vary somewhat from state to state, but in general, to be licensed a pharmacist must graduate from an accredited college of pharmacy participate in residency or internship programs to acquire direct, hands-on patient care experience pass a rigorous examination, known as the NABPLEX (National Association of Boards of Pharmacy Licensing Examination) The pharmacist s educational experience does not end upon being licensed. Most states require licensed pharmacists to take continuing education courses every year in order to maintain their licenses to practice. Pharmacists obtain this additional education through correspondence courses, attending professional meetings and seminars presented by pharmacy associations, or participating in courses provided by the schools and colleges of pharmacy. ASHP According to the American Society of Health-System Pharmacists (ASHP), acute-care pharmacists generally work in hospitals as a vital component of the health care team, consulting with physicians and other health professionals to ensure that patients receive the appropriate drug therapies. These pharmacists oversee the accurate dispensing of medication orders and ensure safe medication use by monitoring drug dosage and response, timing, and preventing possible drug interactions and adverse reactions. The ASHP recognizes the need for at least the following professional manpower categories in institutional pharmacy practice: Generalists Clinical practitioners 2 A supplement to Briefings on Credentialing 781/639-1872 05/02

Specialized practitioners Managers and administrators The society believes that residency training programs have proved to be the best source of highly qualified hospital pharmacy manpower and that it has an obligation to support residencies in each of the manpower categories through the development of training standards and a program of accreditation. To ensure adherence to the principles and philosophy of such standards, the society has established an accreditation program for these residency-training programs. The ASHP publishes the guidelines Minimum Standard for Pharmacies in Hospitals. In these guidelines, the ASHP states that pharmacists, as providers of pharmaceutical care, are concerned with the outcomes of services and not just the provision of services. The elements of a pharmacy program that are critical to overall successful performance in a hospital include the following: Leadership and practice management Drug information and education Activities to ensure rational medication therapy Drug distribution and control Facilities Participation in drug therapy research The ASHP further states that hospitals should strive to meet the pharmacy practice standards of the ASHP and the JCAHO or other appropriate accrediting body regardless of the particular financial and organizational arrangements by which pharmacy services are provided to the facility and its patients. Positions of other interested parties ACPE The American Council on Pharmaceutical Education (ACPE) is the national agency for the accreditation of professional degree programs in pharmacy and providers of continuing pharmaceutical education. The council is an autonomous and independent agency whose board of directors has members from AphA, the American Association of Colleges of Pharmacy, the A supplement to Briefings on Credentialing 781/639-1872 05/02 3

National Association of Boards of Pharmacy, and the American Council on Education. In its Accreditation Standards and Guidelines for the Professional Program in Pharmacy Leading to the Doctor of Pharmacy Degree, the ACPE states that a college or school of pharmacy should offer a curriculum in pharmacy that is intended to prepare its graduates to become generalist practitioners of pharmacy. The goals and objectives of the curriculum in pharmacy should embrace the scope of contemporary practice responsibilities as well as emerging roles that ensure the rational use of drugs in the individualized care of patients as well as in patient populations. The organized program of study should provide students with a core of knowledge, skills, abilities, attitudes, and values that are necessary to the provision of pharmaceutical care and should provide opportunity for selection by students of courses and professional experiences in keeping with particular interests and goals. The need for life-long learning should be reflected as an integral theme of the curriculum. The ACPE further states that the curriculum in pharmacy should provide sufficient content for the achievement of the professional competencies necessary to the general practice of pharmacy and to satisfy educational requirements for licensure as a pharmacist, and should meet the requirements of the institution for the doctor of pharmacy degree. The college or school of pharmacy s organized plan of study should focus upon the content, sequence, process, and outcomes of the curriculum. The curriculum for the professional program in pharmacy requires a minimum of four academic years or the equivalent in order to ensure achievement of the professional competencies necessary to become a generalist practitioner who renders pharmaceutical care. BPS According to the Board of Pharmaceutical Specialties (BPS), board certification is a voluntary process for those who are already licensed to practice pharmacy. It indicates that a pharmacist has demonstrated an advanced level of education, experience, knowledge, and skills beyond what is required for licensure in a particular specialty practice area. The BPS grants board certification in the following five specialty practice areas: 4 A supplement to Briefings on Credentialing 781/639-1872 05/02

Nuclear pharmacy, which requires 4,000 hours of education/experience. Nutrition support pharmacy, which requires completion of a nutrition support specialty residency or fellowship plus one year of practice, or have a minimum of three years practice with substantial time spent in nutrition support pharmacy activities. Oncology pharmacy, which requires three years of practice with substantial time in oncology pharmacy or completion of an oncology specialty residency and at least one additional year of practice with substantial time in oncology pharmacy. Pharmacotherapy, which requires certification candidates with a bachelor of science degree to have either five years of practice, or complete a residency and have a minimum of three years of practice, or complete a general residency and a specialty residency. Candidates with a doctor of pharmacy degree must have completed a residency, or have a minimum of three years of practice. Regardless of pharmacy degree, all practice experience must include a substantial component of patient care activities in pharmacotherapy. Psychiatric pharmacy, which requires either completion of a psychiatric pharmacy specialty residency plus one year of practice or a minimum of four years practice with substantial time spent in psychiatric pharmacy. There are the following four basic eligibility requirements for board certification: Entry-level pharmacy degree Current active pharmacy license Defined additional training and experience in the specialty Passing the specialty certification examination The term added qualifications is used by the BPS to denote the demonstration of an enhanced level of training and experience within one segment of a specialty recognized by the Board. As of October 2000, two areas of added qualifications have been approved within the pharmacotherapy specialty: cardiology and infectious diseases. A supplement to Briefings on Credentialing 781/639-1872 05/02 5

JCAHO In regard to pharmacist qualifications, the JCAHO states that hospitals have to be in compliance with the following human resources standards from the 2002 Comprehensive Accreditation Manual for Hospitals: HR.1 The hospital leaders define the qualifications and performance expectations for all positions HR.2 The hospital provides an adequate number of staff members whose qualifications are consistent with job responsibilities HR.4 An orientation process provides initial job training and information and assesses the staff s ability to fulfill specified responsibilities HR.4.2 Ongoing inservice and other education and training maintain and improve staff competence and support an interdisciplinary approach to patient care HR.5 The hospital assesses each staff member s ability to meet the performance expectations stated in his or her job description The JCAHO is currently conducting a field review of standards for medication use that have been revised to increase the focus on patient safety. The field review, approved by the Standards and Survey Procedures Committee of the Board of Commissioners, is for hospitals, long term care facilities, and ambulatory care organizations. The standards were devised with the input of two expert panels and follow recommendations to use a systems approach that focuses on safety. The revisions address the key processes of a medication use system, including selection, procurement, and storage prescribing or ordering and transcribing preparation and dispensing administration monitoring The Standards and Survey Procedures Committee is expected to reassess the field review results during the summer of 2002. The earliest that revised medication use standards would be implemented is January 2003. To review the revised standards for medication, go to www.jcaho.org/standard/hap_meduse_fr_std.html. 6 A supplement to Briefings on Credentialing 781/639-1872 05/02

CRC draft criteria When a hospital receives a request from a pharmacist, it should not be the first time the hospital considers whether this type of practitioner should be granted clinical privileges or specified services. The policy covering hospital pharmacists should be drafted ahead of time by the designated committee/department for recommendation to the governing board and should consider state laws, the needs of the community, the medical staff, peer review, liability, and the hospital s mission and strategic plan. Criteria should be in place covering qualifications, scope of practice, and supervisory requirements. All provision of services should be in accordance with written policies and protocols governing allied health professionals developed and approved by the relevant medical staff department, medical executive committee, and the governing board of the hospital. The following draft criteria are intended to serve solely as a starting point for the development of an institution s policy regarding this practice area. Minimum threshold criteria for requesting core privileges in hospital pharmacy Minimum education and formal training: Applicants must graduate from an ACPE-accredited school or college of pharmacy hold a current, valid license to practice pharmacy complete one year of professional pharmaceutical training in a hospital setting or one year of clinical graduate work in an ACPE-accredited school or college of pharmacy Required previous experience: Applicants must be able to demonstrate that they have provided pharmacy services to at least 50 patients in the past 12 months. Note: A letter of reference should come from the director of the applicant s pharmacy training program. Alternatively, a letter of reference regarding competence should come from the director of pharmacy services at the institution where the applicant most recently practiced. Core privileges in hospital pharmacy Core privileges in hospital pharmacy include the following: Participating as a member of a treatment team in planning, A supplement to Briefings on Credentialing 781/639-1872 05/02 7

evaluating, and implementing individualized treatment programs Consulting with physicians in areas such as drug therapy selection, pharmacokinetics, nutritional support, and determination of therapeutic endpoints Counseling and educating patients individually and in groups on drug therapy Explaining to patients the need for medication, effects on disease, potential side effects, and adverse reactions Conducting drug use reviews through review of patients charts and conferences with medical staff Preparing and dispensing medication upon prescription/ physician s order Assessing prescription appropriateness and legibility Evaluating dosages and determining potential of drug-drug, drug-disease and drug-diet interactions and effect of patient related variables in accordance with all applicable state and federal laws, accreditation and Medicare standards, and professional pharmaceutical ethics Monitoring and controlling medication administration and drug distribution in an inpatient care area or outpatient treatment area Consulting with physicians and reinforcing patients knowledge of their medication regimen at the time of discharge Reappointment Reappointment should be based on unbiased, objective results of care according to the organization s existing quality assurance mechanisms. Applicants must be able to demonstrate that they have maintained competence by showing evidence that they have provided pharmacy services to at least 50 patients annually over the reappointment cycle. 8 A supplement to Briefings on Credentialing 781/639-1872 05/02

In addition, continuing education related to clinical pharmacy should be required. For more information For more information regarding this practice area, contact: American Council on Pharmaceutical Education 20 North Clark Street, Suite 2500 Chicago, IL 60602-5109 Telephone: 312/664-3575 Fax: 312/664-4652 Web site: www.acpe-accredit.org American Pharmaceutical Association 2215 Constitution Avenue, NW Washington, DC 20037-2985 Telephone: 800/237-2742 Fax: 202/783-2351 Web site: www.aphanet.org American Society of Health-System Pharmacists 7272 Wisconsin Avenue Bethesda, MD 20814 Telephone: 301/657-3000 Fax: 301/664-8867 Web site: www.ashp.org Board of Pharmaceutical Specialties 2215 Constitution Avenue, NW Washington, DC 20037-2985 Telephone: 202/429-7591 Fax: 202/429-6304 Web site: www.bpsweb.org Joint Commission on Accreditation of Healthcare Organizations One Renaissance Boulevard Oakbrook Terrace, IL 60181 Telephone: 630/792-5000 Fax: 630/792-5005 Web site: www.jcaho.org A supplement to Briefings on Credentialing 781/639-1872 05/02 9

Privilege request form Hospital pharmacist In order to be eligible to request clinical privileges as a hospital pharmacist, an applicant must meet the following minimum threshold criteria: Basic education and minimum formal training: Applicants must - graduate from an ACPE-accredited school or college of pharmacy - hold a current, valid license to practice pharmacy - complete one year of professional pharmaceutical training in a hospital setting or one year of clinical graduate work in an ACPE-accredited school or college of pharmacy Required previous experience: Applicants must be able to demonstrate that they have provided pharmacy services to at least 50 patients in the past 12 months. References: A letter of reference should come from the director of the applicant s pharmacy training program. Alternatively, a letter of reference regarding competence should come from the director of pharmacy services at the institution where the applicant most recently practiced. Core privileges: Core privileges in hospital pharmacy include the following: - Participating as a member of a treatment team in planning, evaluating, and implementing individualized treatment programs - Consulting with physicians in areas such as drug therapy selection, pharmacokinetics, nutritional support, and determination of therapeutic endpoints - Counseling and educating patients individually and in groups on drug therapy - Explaining to patients the need for medication, effects on disease, potential side effects, and adverse reactions - Conducting drug use reviews through review of patients charts and conferences with medical staff - Preparing and dispensing medication upon prescription/physician s order - Assessing prescription appropriateness and legibility - Evaluating dosages and determining potential of drug-drug, drug-disease and drug-diet interactions and effect of patient related variables in accordance with all applicable state and federal laws, accreditation and Medicare standards, and professional pharmaceutical ethics - Monitoring and controlling medication administration and drug distribution in an inpatient care area or outpatient treatment area - Consulting with physicians and reinforcing patients knowledge of their medication regimen at the time of discharge Reappointment: Reappointment should be based on unbiased, objective results of care according to the organization s existing quality assurance mechanisms. Applicants must be able to demonstrate that they have maintained competence by showing evidence that they have provided pharmacy services to at least 50 patients annually over the reappointment cycle. In addition, continuing education related to clinical pharmacy should be required. I understand that by making this request I am bound by the applicable bylaws or policies of the hospital, and hereby stipulate that I meet the minimum threshold criteria for this request. Applicant s signature: Typed or printed name: Date: 10 A supplement to Briefings on Credentialing 781/639-1872 05/02

Clinical Privilege White Papers Advisory Board James F. Callahan, DPA Executive vice president and CEO American Society of Addiction Medicine Chevy Chase, MD Sharon Fujikawa, PhD Clinical professor, Dept. of Neurology University of California, Irvine Medical Center Orange, CA John N. Kabalin, MD, FACS Urologist/Laser surgeon Scottsbluff Urology Associates Scottsbluff, NE Publisher/Vice President: Suzanne Perney sperney@hcpro.com Executive Editor: Dale Seamans dseamans@hcpro.com John E. Krettek Jr., MD, PhD Neurological surgeon Vice president for medical affairs Missouri Baptist Medical Center St. Louis, MO Michael R. Milner, MMS, PA-C Senior physician assistant consultant Phoenix Indian Medical Center Phoenix, AZ Managing Editor: Edwin B. Niemeyer eniemeyer@attbi.com Beverly Pybus President The Beverly Group Georgetown, MA Richard Sheff, MD Practice director Quality and credentialing The Greeley Company Marblehead, MA The information contained in this document is general. It has been designed and is intended for use by hospitals and their credentials committees in developing their own local approaches and policies for various credentialing issues. This information, including the materials, opinions, and draft criteria set forth herein, should not be adopted for use without careful consideration, discussion, additional research by physicians and counsel in local settings, and adaptation to local needs. The Credentialing Resource Center does not provide legal or clinical advice; for such advice, the counsel of competent individuals in these fields must be obtained. Reproduction in any form outside the recipient s institution is forbidden without prior written permission. Copyright 2002 Opus Communications, a division of HCPro, Marblehead, MA 01945. A supplement to Briefings on Credentialing 781/639-1872 05/02 11