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Shaping a New Future
March 19-23, 1994
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Policies defining what pharmacists do as members of the health care team) and model sexual harassment gUidelines will be considered by the APhA House ofDelegates. by Maureen E_ Flanagan
research programs to cover clinical, economic, and humanistic outcomes. The proposed poliCies are the recommendations of APhA's four policy committees-educational, professional, public, and scientific affairs. The committees met last fall to discuss issues raised by APhA members. The committees' recommendations are considered by the APhA reference committees, which hold open hearings to allow members to discuss and debate policy issues. Included in their considerations is input from members during open hearings at the Annual Meeting. The reference committee recommendations are then presented to the House of Delegates, which will vote to adopt, revise, reject, or refer the recommendations back to the appropriate policy committee or the Board of Trustees.
he responsibilities of pharmacists, prescribers, patients, and payers in the appropriate use of drugs and model guidelines to combat sexual harassment in the workplace are among the 23 policy recommendations to be discussed by the 1994 American Pharmaceutical Association (APhA) House of Delegates at the Association's 141st Annual Meeting and Exposition, March 19-23 in Seattle. Other policy recommendations deal with expanding opportunities for pharmacists, including the development of new high-cost drugs and biotechnology products, and the need to change traditional payment systems so pharmacists can handle these products. The policy recommendations also discuss the scientific underpinnings of pharmacy practice in a reformed health care system and the importance of expanding
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P harmacists as Team Players
Sexual Harassment Guidelines
Rarely do phannacists work in isolation. More often than not, particularly when providing phannaceutical care, they function as part of a health care team, working with patients, prescribers, and payers to achieve successful, cost-effective therapeutic outcomes from the medications patients take. Recognizing that providing pharmaceutical care involves many players, the APhA Policy Committee on Public Affairs developed general principles deflning what each member of the team must do and how they should interact with each
Since the 1991 nationally televised Anita Hill-Clarence Thomas hearings on Thomas's nomination to the Supreme Court, sexual harassment has become a cause ceI{~bre. The Navy Tailhook scandal and the current Senate ethics committee investigations of Sen. Bob Packwood (R-Ore.) have kept the issue in the national spotlight. Furthennore, on November 9, 1993, the Supreme Court ruled unanimously that a woman who was sexually harassed on the job need not prove she was psychologically injured to win money damages making it
Team Players continued on next page
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Team Players continued from previous page
other. The guidelines, which will be recommended to the APhA House of Delegates for adoption in March, were proposed after discussions with leadership and staff of several other health care professional associations. In its background policy paper, the committee noted that interactions among the different health care players occur routinely. For example, because of their accessibility in the community, phat.:nacists playa key role in providing pharmaceutical information and services to patients. Patients, too, must become educated and informed about their drugs. In addition, pharmacists monitor drug therapy in collaboration with the p atient and prescriber to ensure compliance and assess therapeutic outcomes. The prescriber has responsibility for diagnosing the patient's illness and for sharing pertinent information in collaboration with the pharmacist and patient to design cost-effective treatment.
Official 1994 Policy Committee Recommendations Policy Committee on Educational Affairs
Members: Holly 1. Mason, West Lafayette, Ind., chairman; Marissa Schiaifer, Spring, Tex. , vice chairman; Brenda K. Adams, Irving, Tex.; Douglas Baldwin, Salt Lake City, Utah; ]. Robert Bradham, Charleston, S.C.; Stephen M. Caiola, Chapel Hill, N.C.; Angela C. Selan, Oak Creek, Wisc.; Jane A. Siebert, Hutchinson, Kans.; andJames P. Wilson, Alexandria, Va. On the subject of "Sexual Harassment in the Workplace" the committee recommends that the Association be committed to the principle that all work environments and educational settings should be free of sexual harassment. The committee recommends that the Association should adopt a model policy on the prevention of sexual harassment. It further recommends that all employers should establish their own written poliCies on sexual harassment prevention and grievance procedures and provide sexual harassment awareness education and training program for all employees. (See Sexual Harassment Guidelines, p.x) Policy Committee on Professional Affairs
Members: "Dewey" Schlittenhard, Fargo, N.Dak., chairman; Sharon Ann Roberson, Phoenix, Ariz., vice chairman; April A. Adams, Tyrone, Ga.; Philip H. Cogan, Ellicott City, Md.; Kenneth R. Couch, Spartanburg, S.C.; Robert H. Hunter, West Point, Pa.; Brian]. Isetts, Hudson, Wisc.; Earlene E. lipowski, Gainesville, Fla.; Jeanne 1. Lucich, San Francisco, Calif.; and Marvin Carl "Monte" Sturgeon, Portland, Ore. On the subject of "Responsiveness to Emerging Product and Payment Systems" the committee recommends thatAPhA:
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The committee emphasized that pharmacists must also know how to work with payers-third party administrators, health maintenance organizations, insurance companies, and the growing number of self-insured employers. Payers are concerned about the increasing cost of drugs as a share of total health care costs, and care directly related to dnlg misadventuring. Pharmacists can help in cutting health plan costs by using their knowledge to improve patient compliance and reduce costs of medications. They can monitor patient outcomes through dnlg utilization review (DUR) and drug utilization management. In drafting the prinCiples to be discussed at the Annual Meeting, the committee specified 11 responsibilities for the pharmaCist, including serving as a dnlg information resource; providing primary care; collaborating with the prescriber and patient in the design of cost-effective treatment regimens that
• Work with public and private sectors in developing timely educational processes that assist pharmacists to implement patient care, understand new payment systems, and apply emerging therapeutic advances to achieve desired patient outcomes. • Support separate payment systems that distinguish compensation for the p rovision of pharmaceutical care from reimbursement for product distribution. • Participate in the identification, development, and implementation of models for procurement and handling of therapeutic and diagnostic pharmaceutical products and devices that assure the continuous provision of pharmaceutical care by pharmacists. On the subject of "Preventing Dispensing-Related Problems," the committee recommends that APhA: • Encourage the development of practice guidelines to identify, resolve, and prevent dispensing-related p roblems. • Support the developmen t of electronic systems that anonymously collect infortnation to record dispensing-related problems. • Assert that pharmacists have a professional responsibility to document and report dispensing-related problems in an ongoing effort to improve the quality of the drug distribution system. • Assume a leadership role in analyzing and interpreting aggregate data regarding dispensing-related problems, and disseminating the results, which will enable pharmacists to further improve medication distribution. Policy Committee on Public Affairs
Members: Gary S. Schneider, Plymouth, Minn., chairman; Carol Petersen, Madison, Wisc. , vice chairman; Edward K. Baker, Rock Springs, Wyo.; llisa B. G. Bernstein, Silver
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produce beneficial outcomes; identifying formulary or generic products as a means to reduce costs; and intervening on behalf of the patient to identify alternate therapies. The patient is responsible for assuming a responsibility for wellness; sharing information with providers, such as medical history, lifestyle, diet, and use of prescription and overthe-counter medications; participating in the design of the treatment program; and understanding the program and the expected outcomes. The patient must also adhere to the treatment and alert prescribers and pharmacists to possible drug-related problems or changes in health status. Prescribers, which can include physicians, nurses, and dentists, are responsible for assessing and diagnosing the patient's illness, using pertinent information in collaboration with the pharmacist and patient in the design of cost-effective treatment regimens, communicating the treatment plan, and collaborating with the patient and the pharmacist in. drug therapy monitoring.
Spring, Md.; William L. Cundiff, Salem, Va.; Carrie Greenwood, Des Moines, Iowa; Mark J. McCurdy, Cambridge, Nebr.; Anthony Palmieri ill, Kalamazoo, Mich.; Brad P. Tice, Marion, Kans.; and Theresa Wells, West Melbourne, Fla. On the subject of "Off-Label Use of FDA-Approved Products," the committee recommends that APhA: • Advocate the collaboration of pharmacists, other health care professionals, industry, and the FDA in developing procedures to evaluate off-label use of FDA-approved products. • Encourage industry and government cooperation to streamline approval of therapeutically beneficial off-label use of FDA-approved products. • Advocate removal of restrictions on reimbursement of pharmaceutical services and FDA-approved products when, in the judgment of the pharmacist, those products are for medically acceptable, off-label uses. On the subject of "Pharmacist-Patient-PrescriberPayer Responsibilities in Appropriate Drug Use," the committee recommends APhA adopt guidelines that defme the responsibilities of pharmacists, patients, prescribers, and payers in the appropriate use of medications. (See Pharmacists as Team Players, p. 71.) Policy Committee on Scientific Affairs
Members: Jack E. Fincham, Omaha, Nebr., chairman; William A. Conyers, lIT, Glasgow, Ky., vice chairman; Wilson O. Allen, Birmingham, Ala.; Amber Andrews, Lynnwood, Wash; Lynn E. Fisher, Akron, Ohio; Barbara S. Jones, Rosemount, Minn.; Hewitt W. Matthews, Atlanta, Ga.; David Newberg, Tucson, Ariz.; Michelle Soble-Lernor, Phoenix, Ariz.; and John D. Thomas, Baltimore, Md. On the subject of "The Scientific Implications of Health Care Reform," the committee recommends that APhA:
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The payers are responsible for determining the objectives and desired benefits of pharmacy service; designing the coverage, with patient and provider input, using productS and services to produce beneficial outcomes; and contracting with providers on the basis of outcomes and efficient use of resources.
New Products, New Payment Systems Expanding the pharmacist'S role in the health care system was the focus of several policy committee recommendations. The Policy Committee on Professional Affairs recognized the need for pharmacists to handle, prepare, counsel on the use of, and monitor the effects of sophisticated medicines. When they' do this, they often embrace a new role in patient care emphasizing on primary care and therapeutic outcomes~ They must also adapt to new procurement and payment systems that separate compensation for pharmaceutical care . from reimbursement for the drug product. '
• Act as an advocate for the public and private sectors to maintain or increase their level of commitment to assure adequate resources for both basic and applied research within a reformed health care system. • Encourage the public and private research communities to preferentially expend resources for the discovery and development of new drugs and technolOgies that provide substantive, innovative therapeutic advances. • Advocate an increased emphasis on outcomes research in all areas of health services, including drug and diseasespecific research encompassing clinical, economiC, and humanistic dimensions (e.g., quality of life, patient satisfaction, ethics). • Encourage interdisciplinary collaboration in research efforts within and between the public and private research communities. The committee also recommends that APhA: • Recognize that effective drug utilization review (prospective, concurrent, retrospective), as a component of pharmaceutical care, depends upon complete and accurate patient information. • Advocate eliminating the economic and operational obstacles pharmacists encounter when conducting drug utilization review for optimal patient care. • Support utilization of universal and comprehensive standards for On-line Real-time Drug Utilization Review (ORDUR) using, as the minimum, standards outlined in the National Council for Prescription Drug Programs, Inc. (NCPDP) manual version 3.2 as a basis for the ongoing development of ORDUR standards. • Encourage the development of a standardized method of electronic transfer of patient medical data between all health professionals involved in the care of a patient.
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The committee recommended that the new models of payment for drug products and pharmacists' services must recognize the different components of pharmacy care: the actual cost of the medication; the costs associated with preparing it; administrative costs and dispensing-related cognitive services, such as prospective DUR and patient counseling; and nondispensing services, such as extensive disease education, screening services, home care consultation, or case management. The committee noted that compensation for these services will require developing and implementing uniform procedure and process codes. The committee also noted that reimbursement to pharmacists for high-tech, high-cost drugs is inadequate, stemming from the increasing complexity and high cost of health care in general. It recommended that pharmacists move to an outcomes-oriented patient care process instead of in a productoriented distribution process. The committee also discussed various ways for pharmacists to handle expensive drugs and not compromise their fmancial viability. These included "justin-time" delivery to avoid stocking the product, modified forms of payment such as consignment for products, or payments from the ultimate payer directly to the manufacturer of the medicine, such as with Berlex's Betaseron. In moving toward this scenario, the committee recommended that APhA work with public and private sectors in developing timely educational processes that help pharmacists implement patient care, understand new payment systems, and apply emerging therapeutic advances to achieve desired patient outcomes. The APhA policy supports separate payment systems that distinguish compensation for providing pharmaceutical care from reimbursement for distribution of a product distribution. The committee further recommended that the Association participate in identifying, developing, and implementing models for procuring and handling therapeutic and diagnostic pharmaceutical products and devices that assure the continuous provision of pharmaceutical care by pharmacists.
Practice Under Health Reform The emphasis on refocusing pharmacists' practices to better position the profession under health care reform was also echoed in recommendations by the Policy Committee on ScientifiC Affairs. The committee recommended that APhA advocate an increased commitment to basic and applied research within a reformed health care system, with a strong emphasis on studying different measures of patient outcomes. The committee noted that the health care environment, which is seeking to spread scarce resources over an increasing population that is in need of the full range of health care services, is undeniably ripe for outcomes and effectiveness research.
AMERICAN PHARMACY
Although funding is expected to be tight, applied research to identify activities stressing a more results-oriented care is seen as the wave of the future . Outcomes of care, specifically related to pharmaceutical care, have become an increasingly important research agenda. The committee identified specific questions regarding clinical, economic, and humanistic outcomes of care, such as assessing treatment approaches for specific diseases, evaluating the roles of the pharmacist in providing primary and preventive care, determining the costeffectiveness and quality of managed care delivery systems, developing alternative financing models for health service, and considering ethical issues in allocating scarce resources. In its recommendations, the committee advocated (1) encouraging researchers to devote more resources for discovering and developing new drugs and technologies that provide substantive, innovative therapy; and (2) supporting an increased emphasis on outcomes research in all areas of health services, including dnlg and disease-specific research encompassing clinical, economic, and humanistic dimensions.
Other Recommendations In addition to the two policy recommendations described above, the following were also proposed: • The Policy Committee on Professional Affairs recommended that APhA encourage the development of practice guidelines to identify, resolve, and prevent dispenSing-related problems. The committee recommended that pharmacists should report all problems-not just those with adverse effects-that occur during drug dispensing. It further recommended that APhA support the development of electronic systems that confidentially collect information to record dispensing-related problems and take the lead in analYZing, interpreting, and reporting the collected data to enable pharmacists to further improve medication distribution. • The Policy Committee on Scientific Affairs recommended that the Association advocate eliminating the financial and operational obstacles pharmacists face when they conduct DUR. The committee endorsed adopting universal standards for on-line, real-time DUR, using, as a minimum, standards developed by the National Council for Prescription Drug Programs. It also encouraged developing a standardized method for electronically transferring patient medical data. • The Policy Committee on Public Affairs recommended that pharmacists, other health care professionals, industry representatives, and the Food and Drug Administration (FDA) develop procedures for evaluating off-label uses of FDAapproved products. If approved by the House of Delegates, the policy would encourage streamlining of the approval process for off-label uses and removing restrictions on reimbursing pharmacists who dispense products for off-label uses.
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Sexual Harassment continued from p. 71
easier for employees to sue over sexual harassment. The ruling also gives juries substantial leeway to decide that certain sexual advances, insults, and other discriminatory behavior constitute unlawful conduct, creating a work environment that most people would agree is hostile or abusive. Closer to home, surveys of APhA new practitioner members reveal that sexual harassment is one of the issues they consider most important. Incidents have been reported between employer and employee, pharmacist and technician, and patient and pharmacist. In response to these concerns, the APhA Policy Committee on Educational Affairs decided it was not enough for the Association to oppose sexual harassment in the workplace. The committee agreed that APhA should be prepared to make available to employers and employees specific model guidelines that could easily be adapted to various work situations. This charge, taken on by the committee in October, represents the first time a policy committee has developed actual guidelines and not simply a recommendation for guidelines. In its policy paper, the committee on educational affairs recommended that the Association be committed to the principle that all work environments and educational settings be free of sexual harassment. The committee further recommended that every employer institute a sexual harassment awareness education and training program for employees and adopt a policy on sexual harassment prevention and grievance procedures. The guidelines are intended to be flexible enough for use in small, independent community pharmacies with only two to three employees, in large community chain pharmacies with many employees; in hospital, nursing home, and hospice settings; and in academic settings. In researching the subject, the committee consulted materials furnished by the Society for Human Resource Management (SHRM) as well as actual guidelines developed by the American Medical Association (AMA), American Society of Association Executives (ASAE), and the American Society of Hospital Pharmacists. The committee discovered that thousands of complaints of sexual harassment have been filed with the Equal Employment Opportunity Commission and other governmental agencies. ASAE estimated that one of every two women will be harassed at some point during her work life. AMA reported that 75% of female medical students, residents, and physicians said they had experienced sexual harassment, and almost none had reported it. In the pharmacy profession, anecdotal information has revealed that many young women pharmacists have been sexually harassed in the workplace. A 1992 Drug Topics survey revealed that of 1,036 respondents, 25% experienced sexual harassment or knew someone who had been harassed. Respondents in chain pharmacies had a higher rate than did their colleagues in independent or hospital settings. One particular concern is the potential liability an employer faces in cases involving sexual harassment, particularly if it Vol. NS34, No.2 February 1994
could be shown that the employer knew of the conduct and took no affirmative steps to remedy the situation. Equal Employment Opportunity Commission guidelines indicate that employers may be held "strictly accountable and thus legally accountable for acts of sexual harassment." If found gUilty, employers could be subject to claims for back wages and reinstatement and also for compensatory and punitive damages. This has led many groups, including SHRM and ASAE, to recommend that an employer have a strong policy backed by an effective system for investigating and resolving complaints internally. As ASAE said in a briefmg on sexual harassment, "the elements of an effective sexual harassment program thus include a proactive stance, clear policy and procedures, widespread publicity, and a strong emphasis on prevention, including training and educational progrants at all levels." The APhA Policy Committee on Educational Affairs concurred, especially since many pharmacies do not have a policy and the pharmacists in charge may not have the time or inclination to develop one. The committee also noted that some pharmacists may not be aware of or understand the type of hostile work environment that interferes with an employee's work performance. The committee recommended that the Association undertake an educational campaign to teach pharmacists about ways they can prevent sexual harassment and how they can use the model policy and procedure. The committee further recommended providing resources for members to use. The APhA guidelines defme sexual harassment and provide examples of different forms harassment can take. They outline grievance procedures that include what a victim should do and how a complaint should be investigated and documented. The guidelines also spell out the investigator's responsibilities in determining whether to act on a complaint, and in deciding whether it constitutes sexual harassment and if remedial action is needed. Maureen E. Flanagan is assistant editor, American Pharmacy.
AMERICAN PHARMACY