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.     

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 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.     

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.     

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.     

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.     

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.     

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.     

Preparing the P & T committee agenda for new drug requests

Preparing an agenda is an important element in conducting an effective P & T Committee meeting. A key responsibility of P & T Committee members is reviewing the rationale for formulary requests. Therefore, it is generally an agenda item. This article describes a process for planning, preparing, and distributing agenda materials for a committee meeting. A specific format and sequence for reviewing new drugs for formulary admission and criteria for selecting new drugs are discussed.     

AMCP Format dossier requests: manufacturer response and formulary implications for one large health plan

BACKGROUND: The Academy of Managed Care Pharmacy (AMCP) Format for Formulary Submissions, a template for health plans to use in developing formulary submission guidelines, has been widely adopted since its initial release in 2000. Many health plans request a dossier (a standardized set of clinical and economic evidence prepared by pharmaceutical manufacturers) to provide information for consideration during the formulary decision-making process. While dossier quality has reportedly improved over time, there is no recent research examining the response rate to dossier requests and the quality of dossiers received. OBJECTIVE: To perform an evaluation of pharmaceutical manufacturers. response to a request for a product dossier prepared using the AMCP Format, and to determine if dossier receipt was associated with a favorable formulary placement. METHODS: The pharmacy and therapeutics (P&T) committee of a mid-Atlantic health plan with approximately 3 million members reviewed 43 drug products from February 2004 through December 2005. A university-based clinical evaluation subcontractor requested dossiers in the AMCP Format by telephone and e-mail from the manufacturers. drug information center about 8 weeks before the committee meeting. A retrospective evaluation of the materials received from the manufacturers was performed. A logistic regression model was developed to determine if dossier receipt increased the likelihood of second-tier copayment formulary placement for new product reviews. RESULTS: Dossiers were requested for 43 products. We received dossiers for 25 products (58%), other drug information (e.g., journal reprints, product labeling) for 10 products (23%), a formulary kit for 4 products (9%), and no response for the remaining 4 products (9%). Of the 25 dossiers, 21 (84%) generally followed the AMCP Format. Unlocked interactive budget impact models were included in 5 dossiers (20%), and modeling reports (without an unlocked interactive model) were included in 12 dossiers (48%). Dossiers were more likely to be received when the time between U.S. Food and Drug Administration (FDA) approval and dossier request was >/- 4 months (65% vs. 27% when <4 months; P <0.05) and when requested from a large manufacturer (top 25 in sales) compared with smaller manufacturers (75% vs. 43%; P <0.05). Dossier receipt did not improve a product.s likelihood for preferred formulary placement; none of the new products for which dossiers were received were assigned to the second copayment tier compared with 33% of the new products with no supporting dossier. The logistic regression model failed to find any correlation between dossier receipt and preferred formulary placement. CONCLUSIONS: Manufacturers met the request for a dossier nearly three fifths of the time. The dossiers were of high quality and generally followed the AMCP Format; the models included in dossiers varied widely in their design and utility. The product manufacturer.s size and the time between FDA approval and dossier request influenced the likelihood of dossier receipt. Receipt of a dossier did not appear to influence the likelihood of a product attaining preferred formulary status.