Operation, formulary decision-making activities of a P & T Committee in a managed care setting

Managing drug benefits in a Health Maintenance Organization (HMO) is perhaps best accomplished through a formulary, as demonstrated by Kaiser Permanente of Colorado. According to Dr. Jim Adams and Ms. Jackie Richardson, the Chairman and Secretary, respectively, of Kaiser Permanente's P & T Committee, since the advent of their formulary only a few years ago, the cost of drugs has been kept well under control, without jeopardizing the quality of care. Both physician and patient education are critical to the success of a formulary in a managed care system--both monumental tasks for Kaiser Permanente of Colorado considering that prescribers exceed 300 and the number of patients they treat approaches 250,000. What is clear in this exclusive Hospital Formulary interview is that HMOs--long recognized for their ability to control costs--can also provide quality health care for patients who use their facilities.     

P & T Committee formulary requests: criteria for admission

The criteria for P & T Committee members to consider when adding or deleting a product to the formulary are discussed. Although each institution will require and develop different standards that reflect the characteristics of the patient population they serve, two general sets of factors should be studied. The anticipated needs of the institution and the therapeutic application of the medication in consideration must be identified. Furthermore, the characteristics of the drug, including pharmacokinetics, biopharmaceutics, and cost must be clearly defined. The P & T Committee formulary decisions are critical in ensuring high-quality, cost-effective health care.     

Challenges of a P & T Committee in a community teaching hospital

Lutheran General Hospital, a 650-bed, tertiary care and trauma center in Park Ridge, Illinois, has had a P & T Committee in place for 11 years. In this exclusive Hospital Formulary interview, David Cooke, MD, and Jackie Kessler, MS, the respective chairman and secretary of that committee, discuss the challenges their committee faces. Somewhat unique to a community hospital, this committee manages a relatively restricted formulary. They attribute their success to dedicated P & T Committee members and a committed pharmacy. Among the more difficult issues still to be resolved at Lutheran General are relationships between pharmaceutical companies and P & T members and the possible institution of a conflict-of-interest disclosure policy, as well as the never-ending battle of evaluating drug use in their institution.     

P & T Committee perspectives: maintaining a successful formulary system in a private community hospital

Institution of an effective formulary and P & T Committee is a difficult but critical task for many private hospitals. In this exclusive Hospital Formulary interview, Drs. Benner, Mykita, and Brown, members of Sutter Memorial Hospital's Pharmacy, Formulary, and Therapeutic Review Committee (their name for the P & T Committee) emphasize the need for a sound formulary system in order to survive the current changes in health care. Sutter Memorial is sophisticated in its delivery of healthcare services, which include advanced neonatology and state-of-the-art heart transplantation. Although good patient care remains the foremost concern, these committee members acknowledge that care must be affordable as well as therapeutically sound. Key to their committee's success is the cooperative effort among the pharmacy, nursing, and medical staff. They foresee the issue of rational therapeutics as a major challenge in the 1990s.     

How a longstanding P & T Committee identifies and meets current therapeutic challenges

The P & T Committee at the University of Michigan, Ann Arbor, has run smoothly for some time. Nevertheless, it is not immune to today's fiscal and drug therapy challenges. In this exclusive Hospital Formulary interview, Dr. Jeoffrey Stross, chairman; Dr. Richard deLeon, secretary; and Dr. Burgunda Volger, a key University Hospital P & T Committee member, candidly describe their committee's philosophy and the mechanics by which it functions. This committee uses restriction to modify inappropriate prescribing, but it also carries out educational activities. As newer, more expensive, therapies become available, the responsibility to ensure efficacious, safe, economical therapy becomes increasingly complex. The following discussion highlights some of their strategies for success.     

Mission, role, and functions of the P & T Committee

This introductory article in a series on P & T Committees discusses the mission, role, and function of the committee in a hospital. With increasing complexity of drug therapy, the committee's mission has evolved into a multifaceted program related to promotion of rational and safe drug therapy within the institution. Components of the mission, the committee's responsibilities and functions, including formulary, policies and procedures, drug utilization review, drug administration, investigational drug studies, and education, are introduced and briefly discussed in terms of their role in the institution, accreditation standards, and published standards of practice. Future articles will provide fuller consideration of these topics.     

P & T Committee rises to challenges of the changing healthcare environment

The ever-increasing importance of the P & T Committee is well illustrated in this exclusive interview with members of a committee from a leading academic, private-practice, health-science center--Rush-Presbyterian-St. Luke's Medical Center. The participants detail the progress achieved in P & T Committee policy making, particularly in recent years. Unprecedented change in the healthcare environment has demanded a more aggressive P & T Committee, and theirs has responded appropriately. Because the medical staff at Rush constitute a unique blend of academicians and private practitioners, the mechanics of their decision making tends to be consensus-related, while the implementation of those decisions is education-oriented. Other P & T Committees can learn from their political and professional strategies in the management of drug therapy.     

P & T Committee response to evolving technologies: preparing for the launch of high-tech, high-cost products. Roundtable discussion

P & T Committees are entering an exciting era in which the introduction of biotechnology-derived pharmaceuticals is providing life-saving opportunities for conditions for which there was little or no hope for a cure. The P & T Committee at Thomas Jefferson University Hospital has anticipated the challenge that these novel therapeutics present, and has already positioned itself for the pending approval of the first therapeutic human monoclonal antibody. Nebacumab (HA-1A, formerly known as Centoxin; by Centocor) will be used for the treatment of gram-negative sepsis. Although this antiendotoxin has a good side effect profile, its use also carries a high price tag. This will raise several difficult ethical issues once the product is introduced. In this exclusive Hospital Formulary roundtable, members of Thomas Jefferson's P & T Committee and Technology Assessment Subcommittee provide their insights for responsibly managing a high-tech, high-cost product such as nebacumab.     

Organization and operation of P & T Committees in the state of Florida: a survey

To determine the structure and function of P & T Committees in Florida, a survey was initiated. Questionnaires were mailed to all 289 hospitals in the state. Topics addressed included hospital demographics (type of service provided, institution ownership, hospital size), P & T Committee structure (size of the committee, membership breakdown by specialty, chairman specialty, number of meetings per year), formulary additions (personnel authorized to request drug additions, process for adding drugs to the formulary, monitoring new drug use), and formulary systems (prevalence of therapeutic interchange programs, methods of communicating formulary changes). Overall survey response rate was 71.5%. In general, P & T Committees in Florida appear to be functioning at a relatively high level. Since there is little current information about the composition and operation of P & T Committees in hospitals around the country, it is hoped that this survey will be useful to P & T Committees that wish to upgrade or expand their activities.     

P & T Committee interview: Establishing and maintaining a dynamic formulary.

In an exclusive interview with Hospital Formulary, Dr. Stephen Rostand and Mr. Herman Lazarus--the P & T Committee Chairman and Secretary of the University of Alabama Hospital--share their experiences in establishing an effective, functional formulary system. Discussed in this interview are the current activities of this Committee which include: reviewing adherence to an established Committee guideline on an effective antibiotic dosing regimen, creating a more effective adverse drug reaction reporting system, and establishing a computerized program to alert prescribers to the possibility of drug-drug interactions. By their willingness to cooperate, communicate, and remain flexible to medical staff requests, this 15-member Committee has been able to maintain a dynamic formulary.     

Potential extension of strict products liability to hospitals: P & T committee liability

Members of Pharmacy and Therapeutics (P & T) Committees and materials managers should be aware of the current trend of court decisions to extend strict products liability or liability without the showing of fault, to hospitals and providers of health care services in favor of innocent consumer-patients. Traditionally, a hospital's defense if charged with strict liability (in tort) was that its primary business is to provide services and not sell products. Recent Texas strict products liability judicial decisions have questioned, but not resolved, whether or not a hospital does sell or legally introduce a product into the stream of commerce. Since it is the function of materials managers, or in the case of pharmaceuticals the P & T Committee, to make the decisions on products that will be used in the hospital, the precedence established by the Texas cases portend further judicial extension of strict liability to providers of health care services.     

Aromatase inhibitors in breast cancer: a review of cost considerations and cost effectiveness

Aromatase inhibitors (AIs) have been evaluated clinically in a wide range of breast cancer treatment settings. Although these agents appear to have clinical superiority, they are more expensive than the therapies (primarily tamoxifen) they have been compared with, thus economic evaluation is required to consider their incremental value to the payer. This paper reviews published economic evaluations of AIs as first-line therapy for advanced cancer, and as adjuvant therapy for early breast cancer. The evaluations in the advanced setting demonstrate a range of different modelling techniques and consider the payer's perspective in three healthcare systems. There is broad similarity in the application of standard cohort Markov modelling techniques to evaluate AIs in the early breast cancer setting, covering four separate health system perspectives. AIs appear cost effective compared with current practice. An analysis in the advanced setting suggests that letrozole may be the more cost-effective AI. No direct comparisons of alternative AIs in the adjuvant setting are reported, although indirect comparisons may be feasible. Future evaluations of treatment strategies over the entire course of the disease may also be needed.