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.     

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.     

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.     

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.     

Concerns of a pediatric hospital's P & T Committee: quality care emphasized over cost considerations

One of the greatest challenges faced by the P & T Committee at Children's Hospital of Denver--a full-service, regional pediatric referral center--is the absence of pharmacologic and pharmacokinetic data for many drugs that are on the market for the treatment of adults but are unapproved for pediatric use. To acquire the needed information, Children's Hospital will rely on its P & T Committee to conduct numerous drug usage evaluations. In addition, the committee is undertaking a cooperative data-exchange venture with other children's hospitals across the U.S. and Canada. Although cost issues must be addressed at Children's Hospital, issues such as quality of care--and even how various formulations taste--are top priorities at this hospital.     

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 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.     

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.     

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.     

Cost containment through P & T committee drug utilization review

Provoked by changes that are occurring in health care, hospitals are currently formulating and implementing strategies to identify and control costs while maintaining the highest quality of care. Because drug costs account for a significant proportion of the hospital supply budget (5 to 10%), there is an increased need for the P & T Committee to become involved in the cost containment effort. This article will demonstrate how an existing program of drug utilization review (DUR) has reduced drug expenses without sacrificing the quality of care or imposing unnecessary restrictions on formulary items. Furthermore, implementation of the DUR program has not resulted in conflict between pharmacy, medical, nursing or administrative staffs within the institution.